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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: NCT05906836 Completed - Healthy Clinical Trials

A Drug Drug Interaction (DDI) Study of Selpercatinib (LY3527723) and Rosuvastatin in Healthy Participants

Start date: July 27, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to determine the effect of selpercatinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with selpercatinib in healthy participants. This study will last up to approximately 26 days excluding screening period.

NCT ID: NCT05906641 Completed - Healthy Clinical Trials

Modulation of Secondary Bile Acids Through the Intestinal Microbiota After Consumption of a High-protein Diet.

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

This study will investigate whether changes in the gut microbiota generated after the consumption of a high protein diet in healthy subjects, modify the production of secondary bile acids. In addition, it will be seen whether a high protein intake modifies postprandial glucose response and its relationship with gut microbiota composition.

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: NCT05904418 Completed - Healthy Clinical Trials

Robot-Assisted US-Based Vertebral Segmentation for Pedicle Screw Trajectory Identification

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

This other clinical trial compares robot-assisted US scanning with handheld US scanning and ground-truth CT data of the lumbar spine in healthy, young volunteers. The main questions it aims to answer are: - Is a 3D reconstruction of a lumbar spine from robot-assisted US scanning equivalent to or better quality than a 3D reconstruction from handheld US scanning? - Can a machine learning algorithm automatically segment the bone anatomy from robot-assisted and handheld US scanning to generate 3D lumbar spine reconstructions? - Can pedicle screw trajectories be identified based on posterior vertebral landmarks of 3D reconstructions of lumbar spines from both robot-assisted and handheld US scanning? Participants will: - fill out a medical history questionnaire - get clinically examined - have an ultra-low-dose (ULD) CT Scan of the vertebra L1 to S1 - have a handheld US scan of the vertebra L1 to S1 - have a robot-assisted US Scan of the vertebra L1 to S1 - fill out a post-study questionnaire

NCT ID: NCT05903664 Withdrawn - Healthy Clinical Trials

Retinal Deep Phenotyping.TM

Start date: November 30, 2023
Phase:
Study type: Observational

This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications. As an exploratory study, there are no endpoints per se, however, the following sub-objective will be evaluated for determining the success of this study: - Collection and characterization of MHRC retinal images from at least 250 participants that score at least 80 on the real-time Quality Index (included in the MHRC software). - Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting.

NCT ID: NCT05903651 Completed - Healthy Clinical Trials

Retinal Deep PhenotypingTM

Start date: April 3, 2023
Phase:
Study type: Observational

This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications. A sub-set of the images will also be analyzed by eye specialists to determine if visual inspection of the images could provide useful information in their practice. As an exploratory study, there are no endpoints per se, however the following sub-objective will be evaluated for determining the success of this study: - Collection and characterization of MHRC retinal images from at least 2000 participants that score at least 80 on the real-time Quality Index (included in the MHRC software). - Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting. - At least 5% of participants shall have an MHRC retinal image reviewed by an eye specialist (Optometrist or Ophthalmologist) to assess the image quality and potential clinical usefulness.

NCT ID: NCT05903183 Active, not recruiting - Healthy Clinical Trials

A Study to Evaluate the Safety and Immunogenicity of IVX-A12 in Participants of 60 to 85 Years of Age

Start date: May 15, 2023
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to assess the safety, tolerability and immunogenicity of a bivalent respiratory syncytial virus (RSV)/human metapneumovirus (hMPV) virus-like particle (VLP) candidate vaccine (IVX-A12) compared to placebo, when administered as a single-dose regimen in healthy older adults 60 to 85 years of age.

NCT ID: NCT05901883 Completed - Healthy Clinical Trials

First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects

Start date: June 20, 2023
Phase: Phase 1
Study type: Interventional

This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CEL383 in healthy volunteers.

NCT ID: NCT05901311 Completed - Healthy Clinical Trials

A Study of [14C]-LY3537982 in Healthy Participants

Start date: June 5, 2023
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to conduct blood tests to measure how much LY3537982 is in the bloodstream and how the body handles and eliminates LY3537982 in healthy participants. This study will involve a single dose of 14C radiolabeled LY3537982. This means that a radioactive tracer substance, C14, will be incorporated into the study drug LY3537982 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of LY3537982. The study will be conducted in two parts. The study will last up to 71 days and 61 days for part 1 and 2, respectively.