Clinical Research Directory

Pharmacokinetics of Huperzine A Oral Solution in Healthy Participants

In this study, 4 dose groups are planned: Group 1 (0.22 mg, QD), Group 2 (0.22 mg, BID), Group 3 (0.44 mg, QD), and Group 4 (0.44 mg, BID). Ten healthy study participants will be enrolled in each dose group, and randomized to the investigational drug group or the placebo group in a 4:1 ratio (i.e., 8 study participants in the investigational drug group and 2 study participants in the placebo group). An appropriate gender ratio will be ensured within each dose group.

Study to Evaluate Safety, Tolerability and Pharmacokinetics of G01 Eye Drops in Healthy Volunteers

The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of G01 when administered as eye drops in healthy subjects.

Effect of Chronotype on Balance and Cognitive Function

Balance is the ability of an individual to maintain posture against gravity and sustain stability during movement; it depends on the coordinated functioning of the proprioceptive, visual, and vestibular systems, as well as the central nervous system. Current studies show that movement control occurs not only through the motor system but also through the interaction of sensory-cognitive-motor components. Cognitive functions encompass processes such as attention, memory, visuospatial skills, and executive functions, with attention and visuospatial processing playing a particularly important role in balance control. The literature reports significant relationships between balance and cognitive functions, particularly noting that increased attention requirements in dual-tasking situations negatively impact balance performance. Furthermore, it has been shown that both balance performance and cognitive functions are affected by circadian rhythm and chronotype, with individuals exhibiting different performance levels at different times of the day. Despite this, studies examining the relationship between balance and cognitive functions appear to have insufficiently addressed the chronotype factor. Therefore, the aim of this study is to investigate how the relationship between balance and cognitive functions changes according to individuals' chronotypes.

Validation of a New System for Measuring Ventilation and CO₂ Production

Gas exchange measurement systems are complex and require specialized facilities and expertise. As a result, access to these measurements remains limited, particularly in the field of sports performance. The aim of this validation study was to compare measurements obtained with a reference device and a new portable system.

Validation of a Remediation Method for Memory Impairments Through Motor Encoding in Patients With Alzheimer's Disease

In France, over 1.5 million people suffer from mild cognitive impairment, often a precursor to Alzheimer's disease (AD), whose global prevalence could reach 153 million by 2050. With no curative treatment available, maintaining patients' autonomy at home is essential to mitigate the negative effects of institutionalization and reduce economic costs. Non-pharmacological approaches, such as cognitive training, have shown potential in stabilizing cognitive functions. Research suggests that motor networks and procedural memory remain relatively preserved in early AD, and bodily engagement during encoding enhances memory. For patients with motor impairments, motor imagery (MI) activates these networks without actual movement. Additionally, dynamic visual cues, like videos, reduce cognitive load compared to static images. This project aims to combine real action, MI, and dynamic visual supports to optimize memory. By validating 120 videos of daily activities, it will assess the impact of action on recall, evaluate MI's effectiveness for patients with mobility limitations, and confirm the superiority of videos over static images. The results could support the development of digital tools, such as serious games, to enhance patients' autonomy and address aging-related challenges.

Platforms Comparison Study - NIXOS-COMPARISON

The purpose of the study is to verify that BulbiCAM®, a video-oculography medical device, gives similar results regardless of the Operating System (OS) used. The study compares three platforms: Windows, Linux Ubuntu, and Linux NixOS.

Autonomic and Peripheral Neurochemical Responses to Maximal Rowing Exercise

The goal of this observational study is to characterize autonomic, neuroendocrine, and peripheral neurochemical responses to maximal rowing exercise and early recovery in highly trained male athletes. The main questions it aims to answer are: * How do circulating concentrations of cortisol, testosterone, dopamine, serotonin, gamma-aminobutyric acid (GABA), and the testosterone-to-cortisol ratio change in response to maximal rowing exercise and during the first hour of recovery? * How do autonomic cardiovascular parameters, including heart rate variability, blood pressure variability, and baroreflex sensitivity, change 3 hours after maximal exercise compared with baseline values? * Do endocrine, peripheral neurochemical, and autonomic responses demonstrate similar or divergent recovery patterns following maximal exercise? Participants will: * Perform a maximal 6,000-m rowing ergometer test. * Undergo venous blood sampling before exercise, immediately after exercise, and 1 hour after exercise recovery for assessment of endocrine and peripheral neurochemical markers. * Undergo noninvasive cardiovascular and autonomic assessment using the Task Force Monitor System before exercise and 3 hours after exercise recovery.

Correlation Studies on Human Body Composition Based on Bioequivalence or Pharmacokinetic Trials

The aim of this observational study is to investigate the impact of body composition on the absorption, distribution, and metabolism of drugs. The primary question it seeks to answer is: Does body composition affect the absorption, distribution, and metabolism of drugs? By combining pharmacokinetic parameters and adverse drug reactions, the study will analyze differences in the metabolism of drugs under various body composition conditions. During the Phase I clinical trial, under the guidance of the researchers, subjects will use the non-invasive InBody S10 body composition analyzer to obtain body composition data, including but not limited to inorganic salts, muscle mass, lean body mass, body weight, and body fat percentage.

Human Milk Oligosaccharides, Gut Bifidobacterium, Vitamin D, and Infant Immunity

The goal of this observational study is to learn how certain natural sugar components in breast milk may be linked with vitamin D level, healthy gut bacteria, and immune markers in healthy breastfed infants. The study will include exclusively breastfeeding mothers and their healthy infants aged 1 to 2 months. The main questions it aims to answer are: * Is this natural sugar in breast milk linked with the baby's vitamin D level? * Is this natural sugar in breast milk linked with healthy gut bacteria? * Is this baby's vitamin D level linked with healthy gut bacteria? * Is this natural sugar linked with immune factors in breast milk? Participants will answer health questions from questionnaire, undergo a brief physical examination, allow breast milk and a small baby blood sample to be collected, and provide an baby stool sample. Researchers will test these samples in the laboratory and analyze the results to answer the research questions.

The Effect of White Tea in Healthy Human Subjects

This clinical study aims to determine the effects of consuming white tea infusion (Camellia sinensis) on healthy subjects over a period of 14 days. The main questions it aims to answer are: 1. Determine the effect of white tea consumption on the anthropometry of healthy subjects. 2. Determine the effect of white tea consumption on the biochemical parameters of healthy subjects. 3. Determine the effect of white tea consumption on hematology parameters that are related to anemia case in healthy subjects. 4. Determine the effect of white tea consumption on the activity of first-line antioxidant enzymes in healthy subjects Researchers used only one treatment group, and respondents knew which treatment they would receive (single-arm and open-labelled), namely white tea infusion to maintain human body health. Participants will: 1. Follow the washout stage for 7 days 2. Drink white tea infusion every day for 14 days. 3. Follow up to monitor adverse effects after consuming white tea; this stage will be conducted for 7 days. 4. Report all food and beverages consumed by respondents during the study.

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect of HSK55879 Tablets in Healthy Subjects.

This is a single-center, random, double blind, placebo control clinical study to evaluate the safety, tolerability pharmacokinetics and food effect of HSK55879 in healthy subjects

A Study to Assess Effect of Dosing Intervals on Multiple-Dose Pharmacokinetics of WD-1603 Taken Before Meals in Healthy Participants

WD-1603 contains two different drugs called levodopa and carbidopa in one tablet. The goal of this clinical trial is to see if taking the study drug WD-1603 at different time intervals affects how the drug acts in healthy volunteers. We also want to learn about the safety of WD-1603. The main question we want to answer is: * How does the body process WD-1603 when it is taken by different time intervals? What will participants do? * Participants will take one tablet of WD-1603 twice a day on three separate days. * On each dosing day, the two doses will be spaced different hours apart. * Between each dosing day, there will be a rest period of up to 7 days.

Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants

This study investigates whether MDMA may have a pain-reducing effect. The effect of MDMA is compared with a placebo (a substance with no active effect). In the study, moderate pain will be artificially created in healthy participants using repeated small electrical pulses applied under the skin. At the same time, participants will take MDMA or a placebo by mouth. This allows researchers to compare how MDMA affects the artificially created pain. A total of 20 healthy volunteers will take part in this study.

Effects of Vibrational Therapy on Pelvic Floor Muscle Strength and Tone in Healthy Women

This quasi-experimental study aims to evaluate the effects of mechanical vibration applied to the pelvic floor musculature in healthy women aged 18-45. The intervention involves vibrational therapy targeting the central fibrous nucleus of the perineum, with the goal of assessing changes in muscle tone, strength, and biomechanical properties. The study will also examine the tolerance to this technique, with data collected at baseline and after 8 weeks of treatment.

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers

A randomized, double-blinded, partial-open, placebo/active-controlled, single/multiple dosing, dose escalation phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of IY-828026 in healthy adult volunteers

Metabolic Effects of Short-Chain Fatty Acids in Healthy Individuals

The primary objective of this study is to investigate the acute physiological and metabolic effects of ingesting the short-chain fatty acids (SCFA)s propionate (three carbon atoms long; C3:0) and butyrate (C4:0) in healthy men and women. This aim will be addressed through a block-randomized cross-over study including two visits with acute intake of propionate and butyrate, respectively. The hypothesis is that plasma ketone body levels will increase during the first three hours after intake of butyrate, but not propionate, in healthy individuals in the overnight fasted state.

Video Game Intervention In Older Adults

The purpose of this clinical trial is to investigate the effects of a rehabilitative game-based intervention on self-efficacy, balance, and visual-motor integration in individuals aged 60 years and older. The primary research questions are: Does the rehabilitative game-based intervention improve balance and visual-motor integration? Does the rehabilitative game-based intervention improve self-efficacy levels? Researchers will compare a rehabilitative game intervention group with a control group. Participants will complete baseline and post-intervention assessments. Individuals in the intervention group will participate in rehabilitative game sessions twice per week for 6 weeks, while the control group will not receive any intervention.

Validation of Virtual Reality Tests for the Assessment of Patients With Age-related Macular Degeneration as Clinical Endpoints

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrialized countries and affects tens of millions of people worldwide, with a rapidly increasing prevalence. It causes irreversible central vision loss and significant difficulties in daily activities, impairing patients' quality of life and independence. Conventional clinical assessments, which focus on visual acuity and retinal imaging, do not fully reflect the functional impact of the disease. Virtual reality (VR) makes it possible to create immersive, controlled environments to accurately measure functional vision and simulate real-life situations. The study proposes to develop a standardized and reproducible functional test in virtual reality that can complement conventional examinations and support clinical and industrial research.

Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion

This study investigates how the naturally occurring gut hormones GIP and GLP-1 influence whole-body glucose uptake and organ perfusion in humans. Using a state-of-the-art total-body PET-CT scanner, the study measures dynamic uptake of the glucose analogue 18F-FDG and blood flow using H₂¹⁵O across multiple organs during controlled elevations of plasma glucose and endogenous insulin secretion. The project consists of two sub-studies. Sub-study 1 includes healthy individuals who undergo three experimental visits with infusions of GIP, GLP-1, or saline (placebo) during a hyperglycemic clamp followed by FDG PET-CT scanning. Sub-study 2 includes healthy individuals and participants with type 2 diabetes who undergo two experimental visits with saline followed by either GIP or GLP-1 during a hyperglycemic clamp, combined with repeated H₂¹⁵O PET-CT measurements of perfusion. The primary aims are to quantify insulin-mediated skeletal muscle glucose uptake (sub-study 1) and skeletal muscle perfusion (sub-study 2). Secondary aims include assessment of glucose uptake and perfusion across adipose tissue, liver, and additional organs. The results will provide novel physiological insight into postprandial glucose metabolism and serve as reference data for future whole-body PET research.

Effectiveness of Artificial Intelligence Integrated Mixed Reality-based High-Alert Medications Management Simulation Program

The goal of this clinical trial is to learn if a Artificial Intelligence integrated Mixed Reality-based High-Alert Medications Management Simulation Program (AIMR-HAM) helps hospital nurses manage high-alert medicines (HAMs) more safely. MR mixes real and virtual elements to let nurses practice in realistic scenarios. The main questions are: Does the AIMR-HAM improve nurses' medication safety skills? Does the AIMR-HAM lower medication errors and improve clinical performance? Researchers will compare two groups to answer these questions: Intervention group: AIMR-HAM Control group: standard education only Who can take part: Nurses who work at large hospitals and have 1 to 6 years of clinical experience. About 60 nurses will join the study. What participants will do: Attend the assigned training (AIMR-HAM or standard education only). Complete short tests and surveys before and after training to measure skills, communication, and clinical reasoning. Report any medication errors that occur during the study. Why this matters: The study will show whether AIMR-HAM training can improve how nurses handle HAMs and make patient care safer.

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women

This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.

Marmet and Oxytocin Massage for Breast Milk Increase

This study is designed as a randomized controlled single-blind experimental study to examine the effectiveness of the oxytocin massage and Marmet technique applied to mothers who have undergone cesarean section on breast milk quantity and maternal state anxiety levels. The hypotheses of the study are as follows: H0.1. There is no difference in the amount of breast milk among mothers in the Marmet technique, oxytocin massage, and control (placebo) groups. H1.1. There is a difference in the amount of breast milk among mothers in the Marmet technique, oxytocin massage, and control (placebo) groups. H0.2. There is no difference in the state anxiety scale scores among mothers in the Marmet technique, oxytocin massage, and control (placebo) groups. H1.2. There is a difference in the state anxiety scale scores among mothers in the Marmet technique, oxytocin massage, and control (placebo) groups. Participants: Marmet technique, oxytocin massage, and control (placebo) groups will be informed about the study and asked to provide their consent. Participants will complete the descriptive questionnaire. Colostrum status will be checked and marked as "present" or "absent" on the "Breast Milk, Vital Signs, and Pain Level Form." Under researcher supervision, the mother will breastfeed her baby. Afterward, the State Anxiety Inventory will be administered. Two hours later, mothers will express milk using a hospital-grade pump, with 15 minutes on each breast (total 30 minutes). Milk volume, vital signs, pain levels, and milk flow rate will be recorded on the relevant form. Following this, mothers in the Marmet group will receive 10 minutes of the Marmet technique, mothers in the oxytocin group will receive 5 minutes of oxytocin massage, and mothers in the control group will receive 5 minutes of light touch on their wrists and shoulders. Immediately after, milk expression will again be performed with 15 minutes per breast (30 minutes total). The State Anxiety Inventory will be re-administered, and milk amount, vital signs, pain levels, and flow rate will be recorded again. All mothers will express milk using a hospital-grade breast pump, and the expression duration is standardized as 15 minutes per breast (30 minutes total) based on the literature. Two expressions will be performed - one before and one immediately after the intervention. Expressed milk will not be discarded and will instead be used to feed the babies via spoon or syringe under the researcher's supervision.

Gamma Transcranial Alternating Current Stimulation in Healthy Adults

Transcranial Alternating Current Stimulation (tACS), particularly at gamma frequencies, may enhance fast brain oscillations (especially gamma and possibly beta), while reducing slower rhythms such as theta. These effects are not confined to the stimulation site (e.g., the precuneus) but can extend to structurally and functionally connected regions, including the default mode network (DMN). Notably, 40 Hz gamma tACS applied to the left dorsolateral prefrontal cortex (DLPFC) has been associated with improvements in working memory and motor learning during reaction time tasks. While beta-frequency stimulation often shows no significant effect, gamma-frequency tACS has been shown to reduce response times. Gamma oscillations are commonly disrupted in neuropsychiatric disorders. These rhythms depend on a balance between excitation and inhibition, possibly linked to interneuron dysfunction. Abnormal gamma activity has been proposed as a biomarker for cognitive impairment. In this context, non-invasive rhythmic stimulation aiming to restore gamma activity is a promising cognitive enhancement strategy, though unlike pharmacological approaches, gamma-tACS has not yet been widely adopted in clinical practice. A meta-analysis of 56 studies emphasized that tACS outcomes vary with stimulation frequency, brain region, and timing protocols. Research suggests that the susceptibility of gamma oscillations to external modulation may provide insights into cognitive reserve, domain-specific processes, and Alzheimer's disease progression. Oscillatory changes may help predict conversion from MCI to Alzheimer's disease. However, evidence on the neural mechanisms of tACS remains limited and heterogeneous, and outcomes appear to depend on task type, frequency, and intensity. In this study, we will deliver a single 20-minute tACS session over the bilateral DLPFC using gamma frequencies (40 Hz, 80 Hz, and individualized gamma), and a theta-gamma coupling range (6-80 Hz). A sham group will also be included. The anodal electrode will be placed over F3, and the cathodal electrode over F4 (10-20 system). Cognitive performance will be assessed pre- and post-stimulation using neuropsychological tests, and EEG will measure theta-gamma phase-amplitude coupling and changes in oscillatory activity.

The Effect of Oral Oxytocin and Atosiban on Social Attention

The main aim of the present study is to investigate whether orally (lingual spray) administered oxytocin influences human social attention and behaviors via oxytocin receptors and whether its effects are dose- and task-dependent.