Clinical Research Directory

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.

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.

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.

Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study

The goal of this clinical trial is to learn how eating different snack foods affects long term hunger and gut health in healthy adults. The study will be conducted remotely over 7 weeks. The main questions it aims to answer are: 1. Does eating a snack bar intervention for 5-weeks change how hungry participants feel throughout the day compared to a control? 2. Does eating a snack bar intervention change gut microbiome, bowel habits, digestive symptoms, and other health measures compared to a control over 5 weeks? Researchers will compare an intervention snack bar to a control snack bar to see if the intervention improves hunger, gut microbiome, digestive symptoms and other health measures. Participants will: * Eat 2 snack bars in place of their usual snacks every day for 4 weeks * Complete health measurements at the start and end of the study: a health questionnaire, 3-day food diary, 3-day hunger \& satiety survey, body measurements, and a stool sample * Fill out a short online survey (under 5 minutes) once a week

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.

Isolated Gastrocnemius Tightness and Tactile Sensitivity

Isolated gastrocnemius tightness is associated with various foot pathologies, particularly metatarsalgia and hallux valgus, and is also commonly observed in the general population. Limited ankle dorsiflexion, typically resulting from tightness of the gastrocnemius-soleus complex, may alter normal gait mechanics and lead to compensatory movement patterns that increase mechanical stress on the lower extremity. It is planned to include a total of 40 participants in this study: 20 individuals with isolated gastrocnemius tightness and 20 without. The participants' plantar tactile sensitivity and postural control characteristics will be compared.

Early Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults

This study is a pre-post, open-label pilot feasibility study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for 1 month. During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers. This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease.

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.

The Effect of Olive Leaf Extract Supplementation on Training-induced Skeletal Muscle Functional and Molecular Adaptations in Healthy Volunteers

The goal of this study is to investigate the effect of combining olive leaf extract supplementation with endurance training (moderate intensity continuous training or sprint interval training). We hypothesize that OLE supplementation during training, as compared to training alone with placebo, will translate into better performance outcomes. More specifically, we hypothesize that the additional benefits of OLE supplementation on performance will be mediated by improved mitochondrial characteristics in skeletal muscle and increased neural activation.

Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study

The goal of this clinical trial is to learn how eating different snack foods affects acute hunger, energy intake and eating behaviour in healthy adults. The study will be conducted remotely over 5 days. The main questions it aims to answer are: 1. Does eating a snack bar intervention change how hungry participants feel later in the same day? 2. Does eating a snack bar intervention change participants' energy intake, nutrient intake and eating behaviour on the same day? 3. Does eating a snack bar intervention change participants mood, energy levels and alertness later in the same day? Researchers will compare an intervention snack bar to a control snack bar to see if the intervention improves hunger, energy intake, eating behaviour, and other subjective measures. Participants will: * Eat 2 snack bars for breakfast on 2 separate days, with 2 days in between * Not eat anything after 9pm the night before each test day * Fill out short online surveys (under 5 minutes) before breakfast and at set times over the next 3 hours * Not eat for 3 hours after breakfast * Write down everything they eat that day

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

Yeast Protein for Muscle Mass

Protein supplementation is said to be one of the cost-efficient and practical strategies to meet protein needs for growth and exercise, and can help maximize muscle gain from resistance exercise. It facilitates faster recovery from stress-induced tissue damage and enhances performance output. Protein sources derived from animal products are generally recognized as the highest quality protein. However, altering the protein composition of a protein source can improve the protein quality. The yeast protein supplement the investigators will use in this study has a similar amino acid composition to whey protein, which is derived from an animal product, but it is produced more sustainably. The study aims to compare the effects of yeast and whey protein on muscle mass over 16 weeks.

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.

Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure

The goal of this observational study is to evaluate the feasibility and usability of at-home urine sample collection, preparation, and smartphone imaging using the EcoExposure™ platform in adults. The main questions it aims to answer are: Can participants successfully collect, prepare, and photograph urine samples at home and upload the images using a smartphone app? How consistent is image quality and participant adherence across repeated sampling over approximately 12 weeks? What is the short-term day-to-day variability in optical signals during an intensive daily sampling period? Participants will: Complete electronic consent and a brief intake questionnaire Collect and prepare urine samples at home at scheduled timepoints Capture guided smartphone photographs of the prepared samples Upload the images and provide brief feedback through the TrialKit app Optionally add a small reference solution (spike sample) to one sample for technical evaluation only The study is fully remote and lasts approximately 12 weeks. It is intended for product development and workflow validation purposes only and does not involve any diagnostic or clinical decision-making.

Alcohol Sensitivity Among Older Adults Who Consume Alcohol

This is a proof-of-concept study exploring individual differences in sensitivity to alcohol among older healthy current drinkers aged 65 to 80. Participants will complete two sessions during which they will complete questionnaires and laboratory measures of mental abilities and brain activity and receive a beverage that may or may not contain a moderate dose of alcohol.

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.

Replacing Meat With Legumes in a Mediterranean Diet

This study will investigate whether replacing grass-fed organic meat with legumes within a Mediterranean diet affects cardiometabolic health in healthy adults. Participants will be randomly assigned to follow a Mediterranean diet that includes either grass-fed organic meat or legumes as the main protein source for 8 weeks. The study will compare changes in blood cholesterol, blood glucose, inflammation, blood pressure, and other health measures between the two groups. The main outcome will be the change in LDL cholesterol, a type of cholesterol associated with cardiovascular health. The study will include healthy adults aged 25 to 65 years living in the Community of Madrid, Spain.

Anchoring and Postural Stability

This study will compare standing balance in adults ages 18 to 50 during normal standing, inward anchoring, and outward anchoring. Anchoring involves standing with the feet wider than shoulder width and trying to pull the legs together or push them apart without moving the feet. Participants will complete all three conditions in a randomly assigned order. A researcher will use a handheld force-measuring instrument at six points on the pelvis to measure how much pressure participants can resist before a foot lifts from the floor. Participants will also rate how stable they feel after each anchoring condition. The first 18 participants will repeat assessments to evaluate measurement consistency. Participation is expected to last 60 minutes, or 90 minutes for those completing repeat assessments.

A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function

This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.

Effects of Transcutaneous Vagus Nerve Stimulation on Pain and Brain Activity in Healthy Adults

The goal of this clinical trial is to learn whether stimulating a nerve in the neck changes how much pain people feel. It also looks at whether this stimulation changes brain activity. The study is being done in healthy adults ages 18 to 70. The nerve being studied is called the vagus nerve. It runs through the neck and connects to parts of the brain that handle pain. In this study, the nerve is stimulated from outside the body using a small device placed on the skin. There is no surgery, and nothing is implanted. The main questions it aims to answer are: (1) Does stimulating the vagus nerve lower the pain people feel during a cold water test? (2) Does stimulating the vagus nerve change the electrical activity in the brain? Researchers will compare pain ratings and brain activity under three conditions in the same person: no stimulation, real stimulation over the vagus nerve, and sham stimulation placed nearby on the neck. Sham stimulation feels similar but is not aimed at the nerve. Participants will: (1) Come to one visit that lasts about 90 minutes, with no follow-up visits, (2) Wear a cap that records the brain's natural electrical signals for the whole visit, (3) Place both hands in cold water, about 39 degrees Fahrenheit, up to three times for up to 2 minutes each time, (4) Rate their pain after each cold water test, (5) Wear a stimulation device on the neck during two of the three cold water tests, (6) Not be told which of those two is the real stimulation until the visit is over.

Validation of Different Methods for HepQuant DuO® Blood Sample Collection

This is a study to see the agreement of blood samples collected through different means and tube types for the HepQuant DuO Test. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data from patients living with chronic liver disease and healthy adult volunteers. The study has up to 2 study visits at an outpatient clinic and can take up to 4 weeks for a participant to complete study. At these visits, participants will undergo a HepQuant DuO test and other standard lab tests. In addition, the study team will ask about a participant's experience with different blood sampling methods.

Effect of Atogepant on the Vestibulo-Ocular Reflex in Healthy Adults and Adults With Migraine

Researchers want to find out how a substance in the body called CGRP affects balance. CGRP (calcitonin gene-related peptide) is a small protein involved in migraine. Several approved migraine medicines work by blocking it. Studies in animals suggest that CGRP also helps a reflex called the vestibulo-ocular reflex, or VOR. The VOR keeps vision steady when the head moves: when the head turns, the eyes move the opposite way by the same amount, so the world does not appear to jump. Animals that lack the CGRP receptor have a weaker VOR. It is not known whether blocking CGRP weakens the VOR in people. This study tests whether a single dose of atogepant changes the VOR in people. Atogepant is approved in Switzerland for the prevention of migraine and blocks the CGRP receptor. In this study it is used in a different way than it is approved for. Eighty people will take part at the University Hospital Zurich. The study runs in two parts. First, 40 healthy people join. After that, 40 people who have episodic or chronic migraine join. Everyone receives both of the following, in random order: one capsule containing atogepant 60 mg one capsule containing placebo (a capsule with no active medicine) The two test visits are at least 5 days apart. A computer decides which capsule each person receives first. Neither the participants nor the study team know which capsule is which until the study is finished. At each test visit, the participant swallows the capsule at the study centre and stays for at least 90 minutes. Balance and eye-movement tests then begin, about 90 to 120 minutes after the capsule. The tests record eye movements while the head is moved quickly, while warm and cool air or water is placed in the ear canal, while a chair turns gently from side to side, and while the whole body is tilted. Participants also answer short questionnaires about nausea and dizziness before and after the tests. Each test visit lasts about 2 hours and 45 minutes. A short follow-up visit or telephone call takes place within 7 days after the second test visit. People aged 18 to 65 can take part if they have no balance disorder and meet the other study requirements. People cannot take part if, for example, they are allergic to atogepant, have taken a CGRP-blocking medicine in the past 6 months, have severe kidney or liver problems, have unstable heart disease, have a pacemaker, or are pregnant or breastfeeding. Participants are not expected to get a health benefit from taking part. The study is done to learn more about how CGRP works in the balance system, which may help in developing treatments for dizziness and migraine in the future.