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NCT ID: NCT05919589 Recruiting - Healthy Clinical Trials

Evaluating Care Integration for Children With Special Health Care Needs v1.0

Start date: November 1, 2023
Phase:
Study type: Observational

The Evelina London Children's Hospital (ELCH) is planning to integrate care for children with special health care needs (CSHCN) using a package of support, including 1) family support workers to manage care coordination and support parents, and 2) 'navigation' packs outlining key services, for both the services users and providers. This study aims to explore the views and experiences of key stakeholders involved with these services, including the parents/caregivers of CSHCN, and professionals/staff team members. These will be explored using semi-structured qualitative interviews.

NCT ID: NCT05916560 Recruiting - Healthy Clinical Trials

A Study of LY3437943 in Participants With Impaired and Normal Liver Function

Start date: July 13, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the screening period.

NCT ID: NCT05908474 Recruiting - Healthy Clinical Trials

The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults

IOFW
Start date: April 25, 2023
Phase: N/A
Study type: Interventional

Despite availability of many alternative and conventional weight loss options, the prevalence of obesity increased from 15% in 1993 to 27 in 2015. In 2015, 68% of men and 58% of women in the UK were overweight or obese. Overweight and obesity increase the risk for comorbidities such as hypertension, dyslipidaemia, cardiovascular disease, type 2 diabetes and certain cancers. Hormonal regulation of appetite has been shown to influence body weight and body fat . Gut hormones secreted from the intestine are particularly important both in the regulation of appetite and blood glucose level, and recently the gut hormone Glucagon Like Peptide -1 (GLP-1) has been successfully targeted to treat both type 2 diabetes and obesity. Targeting the gut microbiota has been shown to influence gut hormones, in a way is likely to help treat or prevent obesity and type 2 diabetes. In past decades, considerable attention has been given to investigating the new applications of natural prebiotic polymers on gut microbiota composition. Moreover, recent trend in research indicates a bidirectional communication between the gut microbiota and the central nervous system through the microbiome-gut-brain axis (MGBA). Therefore an in vivo intervention feeding study is proposed performed with a variety of psychological and nutritional tests aiming to compare io fibrewater with an equivalent placebo control water and also highlight both cognitive function, emotional bias and response to appetite and also metabolic profiles of the gut microbiota.

NCT ID: NCT05908461 Recruiting - Healthy Clinical Trials

The Early Childhood Friendship Project - Phase 3

ECFP-3
Start date: August 16, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the impact of the Early Childhood Friendship Project (ECFP) on changes in aggression/peer victimization subtypes, prosocial behavior, and social and academic competence with a teacher-implemented (with coaching) version of the program. Further, investigators will examine whether changes in executive functioning, emotion regulation, and hostile attribution biases indirectly account for the program effects. Investigators will test if physiological reactivity (skin conductance and respiratory sinus arrhythmia) serves as moderators of intervention effects. Data will be collected from 600 children (30 randomly assigned preschool classrooms) diverse in socioeconomic status and race/ethnicity. Investigators will use multiple methods (school-based observations, direct academic assessments, child interviews, physiological reactivity using two tasks, observer, caregiver, and teacher reports) to assess the efficacy of the program, hypothesized mechanisms, and role of physiology as a moderator of intervention effects. The duration of the effects will be tested at both 4 month and 12-month follow-up and will thus demonstrate the impact the program has on children's school readiness and transition to kindergarten. It is expected that preschool children randomly assigned to the ECFP intervention relative to the control condition will show significant and moderate reductions in physical and relational aggression/victimization at post-test and follow-up; the ECFP intervention group will also show increases in prosocial behavior, social competence, and academic competence, relative to the control group at post-test and follow-up (4-months at the end of preschool and 12 months after transitioning to kindergarten). Additionally, it is hypothesized that changes in executive functioning, emotion regulation, and hostile attribution biases will mediate treatment effects from baseline to respective follow-ups. It is anticipated that these hypothesis will be moderated by gender such that effects will be stronger for girls relative to boys. Finally, it is hypothesized that physiological reactivity will act as a moderator of intervention effects and of the executive functioning, emotion regulation, and hostile attribution biases mechanisms.

NCT ID: NCT05905029 Recruiting - Healthy Clinical Trials

Establishment of Biomechanical- and AI- Based Rehabilitation Strategies for Pain Inducing Lifestyles

Start date: August 4, 2023
Phase:
Study type: Observational

To develop biomechanical indicators for pain-inducing lifestyles and apply lifestyle strategies for patients and confirm their effectiveness to be used in artificial intelligence-based digital treatment devices.

NCT ID: NCT05899517 Recruiting - Healthy Clinical Trials

Oxytocin Effects on Self Versus Other Touch

Start date: June 22, 2022
Phase: N/A
Study type: Interventional

The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others.

NCT ID: NCT05898555 Recruiting - Healthy Clinical Trials

Validation of Smart Garments for Gait Classification

Start date: May 26, 2023
Phase:
Study type: Observational

The aim of this study is therefore to validate Myant SKIIN garments for the purpose of gait and balance assessment. To achieve this, we recruit young healthy adults from the University of Waterloo to wear Skiin products (see Fig. 1). Participants will be asked to perform a number of scripted gait and balance tasks.

NCT ID: NCT05896553 Recruiting - Healthy Clinical Trials

Effects of Oxytocin on the Functional Architecture of the Brain Before and After Prolonged Naturalistic Fear Induction

Start date: May 29, 2023
Phase: N/A
Study type: Interventional

The main aim of the pharmacological resting-state fMRI study is to investigate the modulatory effects of intranasal Oxytocin (24IU) on task and intrinsic functional connectivity before and after prolonged exposure to naturalistic fear induction via a movie.

NCT ID: NCT05896384 Recruiting - Healthy Clinical Trials

A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood

Start date: December 7, 2023
Phase: Phase 1
Study type: Interventional

This study is open to women with overweight or obesity who are otherwise healthy. Women with a body mass index (BMI) from 27 to 40 kg/m2 can participate. The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of ethinylestradiol and levonorgestrel in the blood. Ethinylestradiol and levonorgestrel are ingredients of the contraceptive Microgynon®. The study has 2 treatment periods. In Period 1, participants get 1 tablet of Microgynon®. In Period 2, participants get weekly injections of BI 456906 for 7 months. The doses of BI 456906 increase each month. At 8 specific timepoints during Period 2, participants also get 1 tablet of Microgynon®. Participants visit the study site up to 40 times. At 8 visits, participants take Microgynon® and stay overnight at the site. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of ethinylestradiol and levonorgestrel in the blood in Period 2 with the amounts in Period 1. Doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05895474 Recruiting - Healthy Clinical Trials

Safety Assessment of Central Medial Thalamus Stimulation Using Transcranial Focused Ultrasound

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

The purposes of this research study are to investigate closed-loop and personalized focused ultrasound as a technique to study how the brain works and to evaluate the safety and effectiveness of the Attune ATTN201 device. This study will objectively assess brain parenchyma morphology, and neuropsychiatric and neuropsychological function, following Transcranial Focused Ultrasound (tFUS) exposure. Electroencephalographic recordings during parametric sweeps will be obtained for observation of changes in the brain network activity, primarily focused on the Central Medial Thalamus (CMT). The CMT maintains strong network connectivity to the cortex and plays a potent role in sleep induction. tFUS has recently emerged as a powerful tool for targeted deep brain neuromodulation and has, in theory, the ability to modulate the activity of the CMT without affecting overlying tissue.