Clinical Research Directory

Human Skin Safety Testing of 1 Mitopure Topical Product Using a Clinical Safety in Use Study in Healthy Volunteers

The objective of this study is to investigate the safety of 1 topically applied test article containing Mitopure in a panel of healthy volunteers.

A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.

Contactless Human-Machine-Interface Based on Magnetometers for Consumer Applications

This study explores the use of novel, highly sensitive quantum-based magnetometers for creating a contactless human-machine interface for consumer applications. These sensors can detect extremely weak biomagnetic fields, such as those from the brain's neural activity (magnetoencephalography), at room temperature. The research aims to quantify interfering biological signals and evaluate the system's performance in detecting user intention for a simple use case. The results will serve as a foundation for developing future applications.

The Effectiveness of Couple Therapy and Relationship Support

This randomized and controlled study investigates the effectiveness of relationship counselling and couple therapy in improving couples' relationship satisfaction and overall well-being. It compares four intervention groups both with each other and with a waitlist control group. The groups are: 1. HUS Self-Help (Mielenterveystalo.fi): Participants independently complete online self-help tasks based on couple therapy, developed by Helsinki University Hospital (HUS) Psychiatry and Väestöliitto. 2. Peloton Parisuhde (eng. Fearless Relationship) Online Course: Based on Emotionally Focused Couple Therapy (EFCT), this course by EFCT trainers Eklund-Mikola \& Pinomaa uses online lectures and exercises to help couples identify negative interaction patterns and strengthen their emotional connection. 3. Short Manualized Emotionally Focused Couple Intervention: Five face-to-face sessions with a couple therapist. 4. Face-to-Face Couple Therapy (Treatment As Usual): 1 to 10 sessions, with the therapeutic approach varying depending on the therapist's training. The study is conducted at the Relationship Counselling Unit of the City of Helsinki's Social Services in Finland, which provides counselling and family guidance under Section 26 of the Social Welfare Act to couples with children living in Helsinki. A total of 200 couples from the unit's treatment queue will be invited to participate and randomly assigned to one of the interventions or the control group, with 40 couples in each group. Participants will complete questionnaires at the beginning and end of the service, and at a 4-month follow-up. The questionnaires measure relationship satisfaction and well-being, among other things. The study also examines how individual, couple-level, and treatment-related background factors influence and mediate the effectiveness of the interventions. In addition to the questionnaires, registry data, therapist assessments, and ongoing treatment feedback collected within the unit is utilized. The results will provide new scientific insights into the effectiveness of short interventions and their suitable target groups and can be used to develop relationship counselling work both within the unit and nationally.

Improving Vaccine Protection for Adults

As people grow older, their immune system - the body's natural defence against diseases - becomes weaker, making them more vulnerable to infections and less responsive to vaccines. This was clearly seen during the COVID-19 pandemic, where older adults were more likely to develop severe illness. Researchers have made an interesting discovery about AS01, an ingredient already used in successful vaccines like the shingles vaccine. They found clues that AS01 might work like a general fitness trainer for the immune system, potentially making it stronger and better at fighting off various types of infections, not just specific ones. To confirm this possibility, we are conducting this research study with adults aged 21-59 to test whether AS01 by itself can boost and train the immune system, how long this boost lasts, and if it actually helps you fight off other infections more effectively.

This Study Evaluates Skin Response Following Application of a Collagen-based Material in Healthy Adult Volunteers Using a Standardized Skin Prick Test. Skin Responses Will be Assessed at Multiple Time Points Following Application, and the Study is Intended to Evaluate Dermal Safety.

This study evaluates the allergic (immunogenic) response following application of a collagen-based material in healthy adult volunteers using a standardized skin prick test. Skin responses will be assessed at multiple time points following application.

Human Repeat Insult Patch Test to Evaluate Skin Irritation and Sensitization in Healthy Volunteers

This study evaluates skin irritation and sensitization following repeated application of a collagen-based material in healthy adult volunteers under controlled conditions. Skin responses will be assessed during study participation.

Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke

Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (\>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.

Effects of Astragalus Membranaceus on Muscle Function

This study evaluated whether daily supplementation with Astragali radix extract (480 mg/day) for 10 weeks could attenuate training-induced impairments in muscle function, joint pain, and inflammatory markers in moderately active young adults undergoing a structured resistance training program. Participants were randomized in a double-blind, placebo-controlled design to receive either Astragali radix extract (ASTRA) or placebo (PLA) during 8 weeks of progressive resistance training followed by 2 weeks of intensified training. The primary outcome was maximal voluntary isometric torque (MVIT) of the knee extensors. Secondary outcomes included one-repetition maximum (1RM) strength, knee range of motion, muscle soreness (VAS), and circulating blood biomarkers of muscle damage and inflammation.

Exploring the Modulatory Role of Brain State on the Prefrontal Response to Excitatory Stimulation

Therapeutic repetitive transcranial magnetic stimulation (rTMS) for depression is well-supported, with multiple protocols approved by the United States Food and Drug Administration and global efforts aimed at boosting its antidepressant effects underway. However, there exists an under-reported aspect of clinical trials using rTMS: what are patients doing during each stimulation session? Here, the investigators begin this investigation with individuals without a history of depression nor other psychiatric diagnosis. The investigators focus on the underlying brain activity. The investigators will systematically assess the modulatory role of brain state on the brain's response to a session of rTMS by using a concurrent, non-invasive brain imaging setting: functional near-infrared spectroscopy (fNIRS), marking the first effort of its kind in this field.

The Dosimetry, Safety and Diagnostic Efficacy of ⁶⁸Ga-FC516 in Healthy Subjects and Patients With Prostate Cancer

This goal of this study is to investigate the dosimetry, safety, biodistribution of ⁶⁸Ga-FC516. In this study, we will evaluate the safety, biodistribution and dosimetry of ⁶⁸Ga-FC516 in subjects and compared them with the results of ⁶⁸Ga-labeled prostate cancer-targeting tracer imaging to evaluate the dosimetric characteristics and diagnostic efficacy of ⁶⁸Ga-FC516.

Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.

The purpose of this study is to understand acute tendon changes after two exercise programs. We will invite individuals with and without shoulder pain to participate in this study. Every individual will participate in both exercise programs separated by up to 15 days. The researcher will evaluate the shoulder tendon using ultrasound before each exercise program and at 1 hour, 6 hours and 24 hours after each exercise program. The researcher will also evaluate self reported pain, pain sensitivity testing, and self reported questionnaires. We will compare the tendon changes after each exercise program, as well as between participants with and without shoulder pain.

The Effects of Palm Olein and Palm Kernel Oil Diets on Gut Hormones and Appetite in Healthy Adults

The goal of this clinical trial is to investigate the postprandial effect of palm olein- and palm kernel oil- diets compared to PUFA-rich diet (sunflower oil in this study) on gut hormones response and appetite in healthy adults. The main questions it aims to answer are: • Do palm olein- and palm kernel oil-diets postulate to improve satiety and lower appetite compared to PUFA rich diet (sunflower oil) in healthy adults? Researchers will compare diets prepared with palm olain or palm kernel oil to a diet prepared with sunflower oil to see the effects of these three diets on gut hormones and satiety score. Participants will: * Attend a health screening session for subjects selection according to inclusion and exclusion criteria. * Visit the study center three times with 2 weeks apart. * Provide blood samples and fill up questionnaires at different time point within 4 hours. * Receive a ad libitum meal after 4 hours intervention.

Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects

The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.

Cerebrospinal Fluid Kinetics of Urolithin A

The purpose of this study is to determine the impact of Mitopure® consumption on urolithin A (UA) kinetics in cerebral spinal fluid (CSF).

Nicotinamide Adenine Dinucleotide Responses to a Nutritional Supplement

The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+) in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.

Phase 1 Trial to Evaluate 150 mg Subcutaneous CIT-013

This is a phase 1, double-blind, randomized, placebo-controlled, single center, repeat-dose trial for the assessment of safety, tolerability, bioavailability and pharmacokinetic profiles of 150 mg CIT-013 in healthy adult volunteers

Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical Trial

This randomized split-mouth clinical trial evaluates enamel surface preservation, pulpal temperature variation, and patient-reported discomfort during ceramic orthodontic bracket removal using two Erbium-doped yttrium aluminum garnet (Er:YAG) laser parameter settings compared to conventional mechanical debonding. Pulpal temperature is monitored in real time using a thermocouple device. Enamel integrity is assessed using the Adhesive Remnant Index (ARI) under 40× magnification. The study aims to determine optimal laser parameters ensuring safe and conservative bracket removal.

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.

Occlusal Contact Registration Using Jaw Tracking Device Versus Articulating Paper at Different Head Positions

this study will test the ability of the Jaw Tracking Device to detect occlusal contacts as an additional data that could be used during diagnosis and occlusion analysis and the results will be compared to contacts gotten from articulating paper and that will be tested at different head position to also detect the changes related to change in condylar position.

Investigating Specific Gait Patterns in Individuals Living With Multiple Sclerosis

The study aims to investigate specific ambulation patterns characteristic of the quality of gait in people with MS (pwMS)

Sex Differences in Exercise-Induced Hypoalgesia

Exercise-induced hypoalgesia (EIH) refers to the reduction in pain sensitivity following acute exercise. Although aerobic exercise has been shown to induce hypoalgesia in healthy individuals, it remains unclear whether the magnitude of this response differs between men and women. This quasi-experimental study aims to evaluate sex differences in pressure pain thresholds following a standardized aerobic exercise protocol using a lower-limb cycle ergometer. Pressure pain thresholds will be assessed before exercise, immediately after exercise, and 30 minutes after exercise in healthy adults aged 18 to 65 years. The findings of this study may contribute to improving individualized exercise prescription strategies based on sex differences in pain modulation.

SweetSpot - The Effect of Non-nutritive Sweeteners on Health

The aim of the study is to investigate the effect of non-nutritive sweeteners on glucose regulation. Secondary objectives are to investigate the effect of NNS on gut microbiome, gut hormone secretion, sweet taste sensitivity and preference, and the excretion of NNS in urine.

Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations

This study plans to learn more about how stimulating the vagus nerve through gentle electrical stimulation applied to the ear can affect decision-making, problem-solving, and other thinking abilities. This process, called transcutaneous auricular vagus nerve stimulation (taVNS), could help improve brain function in both healthy individuals and people with Parkinson's disease (PD).