Clinical Research Directory

Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans

This study is being done to better understand how the immune system responds to vaccination against influenza and rabies. Researchers want to study how immune responses develop and change over time in the blood and in the lymph nodes that drain the vaccination site, following vaccination with two vaccines licensed by the U.S. Food and Drug Administration (FDA): the seasonal trivalent influenza vaccine (TIV) and the rabies vaccine (RabAvert). By studying these samples, researchers hope to learn how the body produces high-quality, long-lasting antibody and memory immune responses after vaccination. The study will also compare immune responses in younger adults to immune responses in older adults, because prior research suggests that the immune system's ability to respond to vaccination weakens with age.

Single-dose Effects of Ayahuasca Compared to Esketamine on Experimentally Induced Pain

This was a randomized, parallel, double-blind clinical trial with healthy volunteers

Ultra-high-performance Positron Emission Tomography (PET) of Synaptic Density, Reactive Astrogliosis and Tau in Alzheimer's Disease

AIM: to investigate the relationship between synaptic density, tau and reactive astrogliosis in Alzheimer's disease (AD) versus healthy controls and centenarians. DESIGN: this cross-sectional study will recruit patients with biomarker-proven AD, age- and sex-matched healthy controls as well as centenarians. All subjects will undergo a neuropsychological evaluation and ultra-high-performance PET imaging sessions with 18F-SynVesT-1 (synaptic density), 18F-MK6240 (tau) and 18F-SMBT-1 (reactive astrogliosis) as well as structural and diffusion MRI. Blood samples will be taken for the evaluation of blood-based biomarkers.

Magnetic Field Maps With NV Application Kit MCG

This prospective, single-center, exploratory feasibility study investigates the use of diamond-based nitrogen-vacancy (NV) magnetometers for non-invasive magnetocardiography (MCG). The goal is to assess whether highly sensitive NV sensors can reliably detect and reconstruct the weak magnetic fields generated by the human heart and evaluate their potential for future cardiac diagnostics.

Pharmacokinetics and Safety of Single-Dose Wafermine™ (Ketamine Sublingual Wafer) in Healthy Subjects

This is a Phase 1, open-label, three-period crossover study evaluating the pharmacokinetics and safety of single-dose Wafermine™ (ketamine sublingual wafer) at dose levels of 25 mg, 50 mg, and 75 mg in healthy adult participants under fasting conditions. Participants will receive all three dose levels in a fixed ascending sequence during a single inpatient admission, with washout periods between doses. Pharmacokinetic sampling will be conducted over 36 hours following each dose.

A Randomized, Double-blind, Placebo Controlled, Parallel Virtual Clinical Trial to Investigate the Efficacy of Marine Oil Products on Omega-3 Status in Healthy Adults

Heart disease is the leading cause of death worldwide. The Omega-3 Index (O3I) is a blood test that measures the amount of the omega-3 fats EPA and DHA in red blood cells. Research suggests that people with an O3I above 8% have a lower risk of dying from coronary heart disease than people with an O3I below 4%. Eating fatty fish two or more times per week may help improve omega-3 status, but many people do not eat enough fish because of taste preferences or concerns about contaminants. Omega-3 supplements, such as fish oil and algae oil, can provide EPA and DHA directly and may help raise the Omega-3 Index. Research suggests that algae oil can be as effective as fish oil for increasing EPA and DHA levels. This study will evaluate whether different fish-oil and algae-oil products-including softgels, liquids, and gummies-improve omega-3 status in healthy adults who eat little fatty fish. Participants will be asked to keep their usual diet, activity, medications, supplements, and lifestyle habits as consistent as possible during the study.

Methylation Analyses for Gynaecological Research Through Home-based Self-sampling

The goal of the MARGOT study is to collect self-samples, such as first-void urine and vaginal samples, from people without cancer and compare them with samples from people with gynecological (pre-)cancers collected in other studies, to better understand the differences in biological markers present in these samples between these two groups.

A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A

This study is evaluating ARD001, an investigational medicine being developed for the treatment of hemophilia A. In Phase 1, healthy adult participants will receive a single dose of ARD001 or placebo to assess its safety and tolerability, how it moves through the body, its effects on blood coagulation, and whether the body develops antibodies against it. If the Phase 1 results support further study and the required regulatory and ethics approvals are obtained, Phase 2 will evaluate repeated doses of ARD001 in adults with hemophilia A. Phase 2 is not currently open for enrollment. The study is designed to determine whether ARD001 can be administered with acceptable safety and to identify doses suitable for further clinical development.

Effects of Different Doses of Ayahuasca on Personality in Healthy Volunteers

Randomized, double-blind, placebo-controlled clinical trial that included 28 healthy volunteers allocated to four experimental single dose groups (n = 7 per group) (ayahuasca 0.5 mL/kg, 1.0 mL/kg, 1.5 mL/kg, or placebo)

Acute Effects of a Single Dose of Ayahuasca on Cerebral Metabolism in Healthy Volunteers: a PET Study

Open-label trial with healthy adults

A Trial in Healthy Participants to Assess Drug Interaction Potential of BGB-43395

This study will enroll healthy participants to evaluate whether BGB-43395 interacts with other drugs, including midazolam, celecoxib, dabigatran, and rosuvastatin.

Investigation of Egg Intake and the Relationship Between Gut Microbiome, Metabolic, and Immune Profiles

The purpose of this intervention study is to investigate the effects of daily egg intake on markers of gut health, high-density lipoprotein (HDL), metabolic, and immune cell profiles in adults with body mass indexes (BMI) in normal and obesity ranges. This study further aims to determine whether egg effects are associated with baseline gut microbiome profiles, and whether egg effects are different between males and females and by BMI status. The study will address the following objectives: Objective 1: Evaluate the effects of daily egg white vs. whole egg intake on gut health, microbiome, and metabolome profiles. Objective 2: Evaluate the effects of daily egg white vs. whole egg intake on HDL composition and function. Objective 3: Evaluate the effects of daily egg white vs. whole egg intake on immune profiles and function in culture (ex vivo). Participants will be asked to consume egg whites and whole eggs on a daily basis for 4-weeks each, and avoid eating eggs for a total of 8 weeks at different points in the study. Participants will be asked to complete surveys about dietary intake and physical activity, as well as provide blood and stool samples throughout the course of the study.

Exploration of Tolerability and Dose Responses for a Yeast-based Probiotic

The purpose of this study is to evaluate the tolerability and efficacy of a yeast-based dietary supplement on gastrointestinal, mental, and skin health. Yeasts are naturally present on fruits and plants, and are used to bake bread, beer and wine. Some of these yeasts are commonly consumed and may actually benefit your gut health. The supplemental yeast could strengthen the gut lining or help good bacteria in the gut grow better. In this study, the investigators will look at how two doses of a yeast-based supplement impacts gut health, bowel movement consistency, and mental health. The study will last 17 weeks and consist of 7 clinic visits (1 screening visit and 6 test visits).

A Phase 1 Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, Drug-Drug Interactions, and Pharmacokinetics of TBD11

This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose trial of TBD11 in healthy adults. It includes a dedicated open-label cohort in which TBD11 will be administered as a single dose with either a strong cytochrome P450 3A (CYP3A) inhibitor (itraconazole) or a strong CYP3A inducer (rifampicin) in 2 trial periods to evaluate DDI. The trial will consist of 3 cohorts; Cohort 1 will occur prior to Cohort 2 and Cohort 3. Cohort 2 and Cohort 3 will start after completion of Cohort 1 and will run in parallel. Cohort 1 will be double-blind and participants will receive 300 mg TBD11 or placebo once daily for 14 days. Cohort 2 will be the open-label DDI cohort. Cohort 3 will be double-blind and participants will receive TBD11 or placebo once daily for 84 days.

A Study to Evaluate the Effect of Carbamazepine or Itraconazole on Radiprodil in Healthy Adult Participants

This is a Phase 1, open-label, 2-part study in healthy adult participants to evaluate the pharmacokinetics and safety of radiprodil when coadministered with either the CYP3A4 inducer carbamazepine or the CYP3A4 inhibitor itraconazole. Up to 36 participants will be enrolled, with approximately 18 participants in Part A and 18 participants in Part B.

Three-dimensional Biomechanics of the Lower Limbs in Healthy Volunteers: Establishment of a Reference Database Using the MERItest® System

Anterior cruciate ligament (ACL) reconstruction is frequently associated with persistent biomechanical impairments despite clinically satisfactory recovery. The MERItest® is a standardized biomechanical assessment battery designed to evaluate movement strategies, muscle strength, and neuromuscular control during functional tasks. However, the clinical interpretation of these assessments is currently limited by the lack of normative data collected using a standardized protocol. This single-center, prospective interventional trial involving minimal risk, aims to establish a biomechanical reference database of healthy volunteers based on measurements obtained during the MERItest® assessment. The development of this normative database will enhance the interpretation of biomechanical outcomes in patients following ACL reconstruction by enabling direct comparison with a healthy reference population assessed under identical conditions.

Breathwork and Stress: Investigating the Mechanisms of Action and Effectiveness of Breathing Interventions in Modulating the Psychophysiological Response to Acute Stress Test

This study investigates whether the psychophysiological benefits of breathing exercises are driven by a specific physiological rhythm (6 breaths per minute) or by the general psychological experience of performing a structured, mindful activity. Researchers aim to determine if "coherent breathing", which is hypothesized to synchronize heart and respiratory rhythms, offers unique physiological protection against stress compared to breathing at a natural pace or simple resting. The main questions it aims to answer are: * Does slow, steady breathing at 6 breaths per minute lower physical stress markers (like heart rate variability and cortisol) better than faster, but structured breathing or just sitting still? * Is the calming effect caused by the specific breathing rhythm or simply by performing a structured, relaxing activity? Researchers will compare three groups to see if the specific rhythm of "coherent breathing" offers unique benefits: 1. Group (Interventional): Coherent Breathing: Slow breathing at 6 breaths per minute. 2. Group (Sham Breathing): Regular breathing at 15 breaths per minute (matching a natural pace). 3. Spontaneous Breathing (Control Group): Natural, unguided breathing. Participants will: * Complete a one-day preparation phase to become familiar with the breathing technique. * Visit the research center for one experimental session. * Perform their assigned breathing method before and after a stress test. * Take the Maastricht Acute Stress Test (MAST), which involves putting a hand in cold water and doing mental math. * Provide saliva samples and have their heart rate variability, and mood measured multiple times.

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment

The goal of this study is to understand how the body processes sonrotoclax in adults with serious liver problems compared to adults with normal liver function.

A Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult Subjects

This is a Phase 1, fixed-sequence, multiple-dose study in approximately 42 healthy adult participants. The study will be conducted in two parts. Part 1 will evaluate the effect of fosmanogepix, through exposure to its active moiety manogepix, on selected CYP enzymes and on the concentration-QT interval corrected for heart rate (QTc). Part 2 will evaluate the effect of manogepix on CYP2C8 and on selected drug transporters. The maximum study duration will be approximately 13.5 weeks for participants in Part 1 and approximately 12 weeks for participants in Part 2.

Foam Rolling and Blood Pressure

Foam rolling (FR) has emerged as a widely adopted modality among rehabilitation practitioners and physically active populations. Previous investigations on FR have reported improvements in joint range of motion, small to trivial enhancements in selected performance measures, attenuation of exercise-induced muscle soreness, and reductions in pain perception. While the evidence base supporting range-of-motion, performance, muscle soreness and pain sensitivity adaptations is relatively well developed, considerably less attention has been directed toward the blood pressure responses to FR and the potential underlying mechanisms. Consequently, the physiological impact of FR on cardiovascular regulation in healthy, normotensive young adults remains insufficiently characterized and requires further systematic investigation. An acute reduction in blood pressure may be postulated, potentially mediated by mechanisms involving changes in total peripheral resistance, which could be linked to modifications in tissue mechanical characteristics. In parallel, a contributory role of autonomic regulation cannot be excluded, as shifts in sympathetic and parasympathetic activity may also influence cardiovascular responses.

The Effect of A Slow-Paced Breathing Intervention on Heart Rate Variability, Stress, and Dysfunctional Breathing Patterns in Healthy Young Adults

The primary aim of this study is to evaluate the effects of a controlled breathing exercises-on autonomic nervous system functions (HRV) and perceived stress levels in healthy young adults with dysfunctional breathing patterns. The secondary objectives of the study are: * To examine changes in HRV parameters, which serve as an indicator of vagal tone. * To identify improvements in participants' subjective stress levels and dysfunctional breathing symptoms following the intervention. This study aims to demonstrate the efficacy of a low-cost, non-invasive, and sustainable respiratory rehabilitation strategy for clinical practice.

Neuroanatomically Informed fMRI Neurofeedback in Healthy Adults

This study will test and refine a type of brain training called functional magnetic resonance imaging (fMRI) neurofeedback in healthy adults. Neurofeedback allows participants to view real-time information about their own brain activity while undergoing an MRI scan and to attempt to modify this activity using mental strategies. The study focuses on a brain circuit involving regions important for decision-making, attention, and emotion. Participants will complete two neurofeedback MRI sessions. In one session, feedback will be based on activity within individual brain regions. In the other session, feedback will be based on communication (functional connectivity) between brain regions, guided by prior knowledge of their anatomical connections. The order of the two sessions will be randomized. The main objective is to determine whether incorporating information about the anatomical organization of brain circuits can improve fMRI neurofeedback. The findings will be used to optimize neurofeedback methods for future studies, including studies involving psychiatric disorders such as obsessive-compulsive disorder (OCD).

A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants

The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order. Participants will be in the study for up to approximately 9 weeks.

Evaluation of a Voice-Activated Call Light System for Clients With Limited Upper-Extremity Mobility

The goal of this study is to evaluate whether a voice-activated call light system enables people in a rehabilitation facility who have limited use of their arms and hands to call for help more independently and reliably than with their previous call light access method. The study will also examine client confidence, family confidence and peace of mind, staff confidence, staff effort, system reliability, and the level of disruption to routine care. The main questions to be answered are: 1. People with what etiologies benefit most from access to the voice-activated call light system? 2. How reliable is the voice-activated call light system in alerting staff to a client's need for assistance? 3. How confident are clients, family members, and staff in the reliability of the voice-activated system for alerting staff of a client's need for assistance? 4. How does access to the voice-activated call light system compare to traditional call light systems regarding staff effort and disruption to routine care? Participants with limited upper extremity movement will use the voice-activated call light system as needed during normal daily activities for up to 90 days. At study initiation, clients with limited upper extremity movement, staff members working with those clients, and family members of the clients will complete a brief questionnaire about their experiences using the existing call light system. At approximately Days 30, 60, and 90, they will complete brief questionnaires about use of the voice-activated call light system and its effectiveness.