Clinical Research Directory

Radiocaine Safety Study

This is a Phase 1, single-center, open-label study evaluating the safety, biodistribution, and radiation dosimetry of Radiocaine™, an investigational fluorine-18-labeled PET radiotracer designed to bind voltage-gated sodium channels. The study enrolls adult volunteers and aims to inform future clinical development in molecular imaging applications. Radiocaine™ is being developed as a potential diagnostic imaging agent and imaging biomarker for the localization and quantification of sodium channel activity.

High Frequency Stimulation to Improve Cognition, Mobility, and Affect in Individuals With and Without Subjective Cognitive Decline

The goal is to determine whether three months of at least three times / week of sensory flicker stimulation improves cognition, mobility, and affect in healthy older adults and older adults with and without Subjective Cognitive Decline (SCD). Investigators will also determine whether the intervention slows cortical thinning and declines in brain functional network segregation and changes in blood biomarkers of Alzheimer's Disease (AD).

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 4-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 4 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 Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon

This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation. The study endpoints chosen for this study are commonly used for evaluating the safety, tolerability, and PK of single doses of IPs. No interim analysis is planned.

Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)

Background: \- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth. Objectives: \- To study how immune system problems may lead to problems in the mouth, including gum disease. Eligibility: * Children and adults at least 7 years of age who have genetic problems with their immune system. * Healthy adults that have periodontal disease * Health adults that do not have periodontal disease Design: * This study will involve a screening visit and a study visit. * Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos. * The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.

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

Phase 1/1b Study of TLC-6740 in Healthy Subjects and Subjects With Obesity, With or Without Diabetes

The phase 1 portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects. The phase 1b portion of the study is designed to assess the safety, tolerability, and PK of TLC-6740 in subjects with obesity, with or without type 2 diabetes mellitus.

Cerebral Cortical Influences on Autonomic Function

This is an exploratory neurophysiological study that will determine the impact of non-invasive brain stimulation on autonomic regulation, with a focus on gastrointestinal function. These studies should provide a basis for future brain-based neurotherapeutic strategies in patients with functional GI disorders.

Studies of Frontal Lobe Brain Functioning in Schizophrenia

The purpose of this study is to use brain imaging technology to investigate the role of the frontal lobe of the brain in the thinking of individuals with schizophrenia and other neuropsychiatric disorders and healthy volunteers. Participants in this study will undergo a positron emission tomography (PET) scan of the brain while performing neuropsychological tests. Some of the tests involve cognitive operations that depend upon the frontal cortex. Interactions between frontal lobe activation, cognitive behavior, and neuropharmacology will be assessed by measuring regional cerebral blood flow (rCBF) during treatment with drugs that may affect frontal lobe physiology.

A Music and Visual Arts Digital Intervention in Teenagers to Promote Healthy Engagement With Social Media.

The primary goal of this interventional study is to explore whether 3 months of arts-based digital interventions can change the way in which teenagers (13-16 years of age) use social media and are affected by them. The main questions it aims to answer are: * Can we give teenagers new, stimulating, and more goal-oriented ways of using social media through arts-based digital trainings and active discussions around social media? * Can these arts-based digital interventions also help teenagers to overcome the negative consequences of social media overuse (such as depression, anxiety, and reduced attention and cognitive performance)? Secondarily, this study also aims to explore the brain and behavioral traits associated with these arts-based interventions to better understand how they work. Researchers will compare a music composition intervention with two other interventions: an active control intervention based on visual-arts instead of music (i.e., photography), and a passive approach to control for the mere pass of time. Participants will: * Complete a baseline and a post-intervention evaluation where researchers will obtain measures of cognitive performance (attention and executive functions, mainly), mood, mental health, brain structure and function, and social media usage and attitudes towards these platforms. * Complete weekly measures regarding their use of social media platforms and their mood. * Complete 3-month arts-based composition / edition intervention (based on music or visual-arts/photography), or the equivalent time with no intervention (passive control group). The motivation of this study was driven by the observation that, in recent years, there has been an increasing use of social media and digital devices in teenagers, while the scientific community still does not fully understand the effects of the overuse of these digital means and platforms. Moreover, some of the negative effects described to be associated with the passive overuse of social media tap on the same brain structures that are benefited by musical and artistic trainings. Hence, we thought it could be worth trying to use arts-based training to help teenagers compensate for or overcome the negative effects of social media at the neural, cognitive, mood and mental health levels. This study introduces novelty through three main aspects. Firstly, it employs a digital art creation approach that requires no classical art training, making it more accessible and less intimidating. Secondly, it incorporates commonly used digital devices (e.g., phones/tablets) and motivating environments into the learning process, integrating the development of new digital skills and the practice of critical thinking around the use of SM into normal classroom activities. Finally, the study employs a multi-methodological approach to explore the brain mechanisms underlying mental-health and cognitive changes resulting from arts-based interventions. Finally, we believe that conclusions from SMART will: * set the basis for developing preventive and therapeutic interventions for depression and anxiety in teenagers, * promote educational programs that provide optimal tools for adolescents to navigate social media in a healthy manner, and * inspire educational policy.

Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)

Background: \- Computed Tomography (CT) is a scan that makes detailed pictures of the body. It uses radiation to do that. In 2011, about 85.3 million CT scans were done in the United States. But there is growing concern about the health effects of radiation. There are new and different ways to make CT pictures that use less radiation. Researchers want to learn whether these new methods create images that are similar to images from a traditional CT. Objective: \- To learn if new CT imaging methods with less radiation make images that are similar to traditional ways. Eligibility: \- Adults 18 years of age and older who are scheduled for a CT of the chest, abdomen and pelvis with contrast. Design: * Researchers will review participants medical records to see if they can be in this study. * Participants may have blood drawn from an arm vein by a needle stick. The blood will be used to make sure they can be in this study and that it is safe for them to have contrast. * During the participants CT scan appointment, one extra scan will be done using low radiation methods. * During a CT scan, the participant lies on a table. A large x-ray machine takes pictures of the body.

A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator.

The objective of this study is to assess the post-infusion recovery and survival of platelets in 100% Plasma treated with INTERCEPT Blood System for Platelets with LED Illuminator and stored for 5 days after apheresis collection. The post-infusion recovery and survival of autologous radiolabeled 5-day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to fresh autologous radiolabeled platelets (Control).

High Image Matrix CT Reconstruction

Background: Computed Tomography (CT) scans make detailed pictures of the body in seconds. CT scans make pictures by passing x-rays through a person. CT scans are common. In 2011, around 85.3 million of them occurred in the United States. Researchers think CT images can be made better using new techniques. Higher resolution images can be derived from the original scan. Objective: To learn if new ways of obtaining and processing pictures of the body from a regular CT scan can produce images with higher resolution (pixels) and more information than standard methods. Eligibility: People ages 18 and older who are scheduled to have a CT scan and are not pregnant Design: Participants will be screened with a review of their medical records. Participants will have their scheduled CT scan. The CT scanner used in this study provides enhanced images of inside the body. Researchers may use the CT scanner in a research mode to test and improve the pictures. Images from the CT scan will be reviewed. Any clinical findings from the CT test will be shared with the participant s doctor. Participants will continue to receive their medical care from their regular doctor. The CT images will be entered into an NIH research database. In the future, they may be used for research purposes.

Capillary-Venous Paired Data Collection

Capillary-venous paired data collection.

Bioequivalence (BE) Study Between YHP2511 and YHP2511A in Healthy Volunteers

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2511 and YHP2511A in healthy volunteers

Avocado and Postprandial Responses

The purpose of this study is to see how adding avocado to a breakfast meal affects blood sugar control and signals of hunger and fullness after eating. The investigators will test the effects of 3 breakfast meals on blood sugar control and signals of hunger and fullness after eating: 1. Whole-wheat bread and strawberry jam 2. Whole-wheat bread, strawberry jam, and avocado 3. Whole-wheat bread and strawberry jam (meal enriched with fat and fiber to mimic that of an avocado) Participants will undergo 3 test periods, each separated by a week. Each test period consists of one day with set meals that the investigators will provide (breakfast, lunch, and dinner), and then the next morning, participants will eat a breakfast meal and have blood drawn several times over 4 hours.

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.

Optimizing Ultrasound-induced Anti-inflammation in Human Subjects

This is a feasibility study to determine whether pulsed ultrasound stimulation targeting the splenic nerve or the cervical vagus nerve can elicit an anti-inflammatory immune response in healthy volunteers.

A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese Subjects

This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.

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.

Bladder and Bowel Functions, Participation and Quality of Life in Children With Intellectual Disabilities

Many neurodevelopmental, psychiatric, and medical disorders are commonly associated with intellectual disability. The presence of neurodevelopmental and psychiatric (NDP) comorbidities has been reported to negatively impact the clinical outcomes of bowel or bladder dysfunction. Pediatric bladder and bowel dysfunction (BBD) is a common but underdiagnosed condition characterized by a spectrum of lower urinary tract symptoms and is often associated with constipation. Lower urinary tract symptoms include dysuria, urinary urgency, daytime incontinence, and enuresis, while bowel symptoms include constipation and encopresis. Most BBD cases are functional and not neurogenic in origin. In children with special needs, all types of urinary incontinence are reported to occur more frequently compared to children without developmental or behavioral disabilities. Intellectual disability (IQ \<70) is also identified as a significant risk factor for urinary incontinence, with prevalence increasing as IQ decreases. In these children, lower urinary tract symptoms such as overactive bladder, dysfunctional voiding, and low fluid intake are also observed. Furthermore, according to support plans and medical records, 94% of individuals with intellectual and multiple disabilities experience constipation. Interestingly, lower levels of intellectual disability (profound and severe ID) have been associated with a lower prevalence of constipation. Although there are studies in the literature examining bladder and bowel functions separately in specific diagnostic groups with intellectual disability, the number of studies that assess bladder and bowel functions together in children with any form of intellectual disability is limited. Moreover, to our knowledge, there is no study in the literature that evaluates bladder and bowel functions along with child participation and parental quality of life in children with intellectual disability. Based on this gap in the literature, the aim of our study is to examine bladder and bowel functions, participation, and quality of life in children with intellectual disability

Imaging of Electrical Properties by MRI: Investigation of Age-Related Changes

The goal of this study is to build a database of personalized EP (Electrical Properties) maps (accounting for age, anatomical location, and tissue complexity), obtained via MRI, to improve electromagnetic safety assessments, especially in the context of MRI. The EP values derived from this study are expected to be more accurate than current literature values, leading to more realistic specific absorption rate (SAR) modeling and improved patient safety. To investigate age-related differences, the study will include three distinct age groups.

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2061

This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061.

Comparing The Effect of Proprioceptive Neuromuscular Facilitation (PNF) When Coupled With Dry Needling (DN), Acupuncture (AN) or Sham Needling (SN) on Knee Range of Motion (ROM), Jump Height and Unipedal Balance

Muscle tightness was found to increase injury risks. Muscle relaese techniques and needling were known to reduce muscle tightness, their specific influence on functional muscle performance remains inconclusive. We hypothesized that (1) combining needling modalities with muscle release techniques (PNF) would significantly improve range of motion, unipedal balance, and jump height compared to a sham intervention; and (2) the specific combination of dry needling and PNF would demonstrate superior functional progression compared to the acupuncture and PNF protocol over a 5-week timeframe.