Goshi, Japan
- Featured
Arise 2 - A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Stimulant use is allowed if certain criteria are met. 4 or 5 non-consecutive overnight sleep tests may be required.
Phase
2Span
Sponsor
Columbia, South Carolina
Recruiting
- Featured
Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Phase
3Span
Sponsor
Flamel Ireland LimitedColumbia, South Carolina
Recruiting
The Effects of High-Intensity Functional Training in Tactical Populations
This study assesses the impact of 8-weeks of high-intensity functional training (HIFT) as compared to traditional resistance training (RT) and concurrent training consisting of RT and high-intensity interval training (HIIT) on various performance outcomes. The main questions the study aims to answer are: - Evaluate the distinct effects of HIFT, RT, and RT plus HIIT over eight weeks on physical performance and body composition measures in tactical men and women. - Determine the distress, training load, and physical readiness associated with each of the three distinct training interventions over eight weeks. Participants will: - Take part in 10-weeks total of study-related activity. - Complete four total sessions of pre and post-testing sessions, which include body composition, maximal oxygen uptake testing (VO2max), upper and lower body maximal strength, and lower body power. - Be randomly assigned to an exercise training intervention.
Phase
N/ASpan
71 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Healthy Volunteers
Theory-based Social Media Intervention for Non-medical Use of Prescription Opioids in Young Adults
Non-medical use of prescription opioids (NMUPO) is a timely and significant public health issue in the United States (US). Young adults are the key population vulnerable to NMUPO. Existing literature indicates that NMUPO in young adults is influenced by a robust array of psychosocial factors. Tailored interventions guided by a psychosocial theory, such as the information-motivation-behavioral skills (IMB) model, are urgently needed for addressing NMUPO in young adults. One innovative approach is to reach out to and deliver psychosocial interventions to young adults via social media technology, yet limited efforts have sought to develop such interventions for NMUPO among young adults. Thus the scientific objective of this study is to gather data via IMB-guided formative study regarding psychosocial influences on NMPUO and then to use these findings to inform the development of a peer-led social media intervention designed to reduce NMUPO among young adults. The objective of this study is to obtain intensive mentored training essential to improving the theoretical and practical expertise needed to develop innovative and implementable peer-led psychosocial interventions for NMUPO in high-risk populations. This study includes three specific research aims. In Aim 1, formative research, guided by the IMB model, will be conducted to explore psychosocial contents associated with NMUPO in young adults. The findings from Aim 1 will be inform the development of a peer-led social media intervention to reduce NMUPO among young adults (Aim 2). The intervention will integrate promising psychotherapy principles and incorporate with peer leaders who are well-trained for recovery coaching. In Aim 3, the feasibility, acceptability, usability, and preliminary efficacy on NMUPO reduction and psychosocial changes of the theory-based social media intervention will be evaluated through a 12-week pilot randomized controlled trial among 70 NMUPO engaging young adults (35 for intervention and 35 for control) via pre-test, 12-week ecological momentary assessment (during the intervention), and post-tests (12-month follow-ups). This project will contribute to future largescale and fully-powered psychosocial interventions for NMUPO among young adults or other high-risk populations using innovative technology that can address challenges in traditional substance use interventions.
Phase
N/ASpan
261 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Healthy Volunteers
Optimizing a Remote-based Physical Activity Intervention for Adults with Total Knee Replacement
All participants will receive a 6-month, fully automated online behavioral exercise program (Energize! Exercise Program). This program is designed to increase moderate-intensity physical activity among individuals who engage in little to no physical activity at baseline. Over the course of the program, participants are given a physical activity goal which starts at 75 minutes per week and gradually progresses to 200 minutes per week. Participants are instructed to view a 10-15-minute video lesson weekly, during months 1-3, and monthly during months 4-6. These lessons teach behavioral principles for increasing exercise and maintaining physical activity long-term. Participants are also asked to complete an 'Apply Your Knowledge' activity after watching each video lesson. These activities are designed to help the participant engage more with the lesson content, with a particular emphasis on applying the content to their lives. Within this program, participants are also asked to plan and report their exercise each week, and automated feedback is provided based upon their weekly physical activity reports. In addition to receiving the Energize! Exercise Program, participants will be randomly assigned to receive 0-4 supplemental intervention components (phone coaching, progress reports to providers, 'Hear From Others' videos, and individualized feedback) which are each described in more detail below.
Phase
N/ASpan
236 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Brain Health Fitness Program: Exercise for People with Mild-moderate Cognitive Impairments
In person Exercise Group: The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist). The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will attend times per week for six months. Coaches will provide exercise plans, and monitor and provide feedback as participants exercise. Participants will wear a heart rate monitor to record exertion. Participants will be able to continuously attend as long as they are attending regularly. Distance Exercise Group: The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist) which will occur in person. The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will exercise on their own 2 x a week for 6 months.Coaches will prescribe an exercise program that can be performed at a local fitness facility or at home and it will be shared through a coaching software. Participants will log their exercises either in the coaching software or in paper formats, have weekly check-ins with fitness center coaches and have options to message the fitness center coaches with questions. Participants who do not log any activity and miss weekly check-ins will have follow up from fitness center coaches.
Phase
N/ASpan
61 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Evaluating the Fade to Fitness Program: a Barbershop-based Program for Black Men
Phase
N/ASpan
74 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Healthy Volunteers
Reducing Metabolic Dysregulation in Dyads
This project leverages our expertise in the epidemiology of colorectal cancer (CRC); disparities; obesity; metabolic dysregulation, an important manifestation of inflammation; the microbiome; animal CRC models; and lifestyle intervention trials to address the growing problem of Early-Onset CRC (EOCRC) (i.e., <50 years). Adiposity and diet drive metabolic dysregulation. So, understanding the interaction between diet and adiposity are key to understanding the genesis of EOCRC - and an array of other obesity-related cancers. This project will address the absence of critical clinical trials and mechanistic studies involving lifestyle interventions for EOCRC. We intend to address this gap; and have the transdisciplinary team representing complementary backgrounds to do so. We focus on dietary modulation of gut microbes to reduce metaflammation and subsequent metabolic dysfunction in obesity, with a goal of preventing EOCRC. We will perform an anti-inflammatory dietary intervention trial in dyads of adults and children at elevated risk for CRC. We also will conduct a complementary mechanistic animal study that builds on and leverages our expertise in mechanistic studies on obesity and CRC. This work is supported by infrastructure that we have built over the past decades in two key centers at the University of South Carolina (USC): (1) Center for Colon Cancer Research (CCCR, 2002 - present - which specializes in mouse models of CRC); and (2) the Cancer Prevention and Control Program (CPCP, 2003 - present - which specializes in the epidemiology of cancer and lifestyle intervention trials for cancer, with a focus on cancer disparities). The two projects that comprise the proposed grant address two Specific Aims that are represented by the human study and laboratory animal experiment: i.e. ,1: To establish the metabolic protective effects of an anti-inflammatory diet in obese, high-risk African-American (AA) and European-American (EA) adults and children in reducing inflammation as indicated by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), IGF-1, Tumor Necrosis Factor alpha (TNFα), Interleukin 6 (IL-6), and C-Reactive Protein (CRP), and a creating more favorable microbiome signature; 2: To establish gut microbes as mediators between anti-inflammatory dietary input and reversal of metabolic dysfunction and associated CRC risk. This complements the human study by carrying out pre-clinical murine model studies with similar inputs (diet), intermediate endpoints (inflammation, microbiome), and outcomes (CRC-related). We hypothesize that an anti-inflammatory dietary intervention will reduce metabolic dysfunction and metainflammation through regulatory effects on gut microbiota. Results from this work will address the role of metabolic dysregulation in relation to factors that are known to be important in carcinogenesis, that therefore could have profound effects on EOCRC, have implications for other obesity-related cancers, and have great promise for moving the field forward by addressing mechanisms that drive large health-related disparities that consistently disfavor African Americans.
Phase
N/ASpan
198 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Healthy Volunteers
Family-Based Prevention With Black and Latinx Children
This pilot project is novel in that it (a) interweaves positive parenting practices, ethnic-racial socialization, and healthy lifestyle behaviors into a prevention program for Black and Latinx families, and (b) targets preschool-aged children using a brief, universal prevention approach, which increases potential for dissemination and scalability. The guiding hypothesis is that incorporating these components into a parenting intervention will lead to improvements in children's health as compared to a control condition. A type 1 hybrid effectiveness-implementation design is used to simultaneously test intervention effectiveness while also gathering information on intervention delivery to inform future implementation trials. The specific aims are to: (a) test the preliminary effects of a preventive intervention on the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children, (b) identify the preliminary effects of the intervention on parenting outcomes, and (c) examine potential barriers and facilitators to intervention delivery.
Phase
N/ASpan
87 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Healthy Volunteers
Optimal Digital Weight Loss Treatment for Rural Individuals
Phase
N/ASpan
209 weeksSponsor
University of South CarolinaColumbia, South Carolina
Recruiting
Healthy Volunteers