Columbia, SC Paid Clinical Trials

The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines \[≥150 min/week of MVPA\]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function. Read Less

The Fade to Fitness Program is a targeted intervention designed to improve the holistic health and quality of life among Black men. This comprehensive initiative focuses on four key health behaviors: Physical Activity, Healthy Eating, Stress Management, and Depression Management. It is grounded in psychological and social theories like Self-Determination Theory, Motivational Interviewing, and Social Cognitive Theory. The program emphasizes the importance of making informed choices, feeling competent and connected, and learning through observation and modeling. Facilitators play a pivotal role, leading group discussions, providing support, and fostering an inclusive atmosphere. The program is structured into weekly sessions that tackle each health behavior, interspersed with off weeks; for community engagement, especially in barbershops, to discuss health topics and promote a healthier lifestyle. Read Less

The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System. A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation. Outcomes will be collected until up to 2 years after surgery. Read Less

The goal of this clinical trial is to test a 6-month, twice a week, moderate intensity exercise and coaching program (an in-person group and a distance group) for adults with mild-moderate cognitive impairments living in South Carolina. The main questions it aims to answer are: 1. Is the program practical to conduct, and it is acceptable and enjoyable? The hypothesis is that it will be possible to recruit participants, obtain the desired dosage of moderate intensity fitness and strength training twice a week. 2. Are their changes at 3-months and 6-months in endurance, mobility, cognitive function and perception of cognitive function? The hypotheses are that endurance, strength and mobility will improve and cognitive measures will not decline (remain the same or improve). Participants will exercise twice a week in-person with a coach or at a distance location with coaching support for six months. Read Less

SUSTAIN (Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder) is a Phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel- group trial to assess the efficacy and safety of solriamfetol in adults with excessive sleepiness associated with shift work disorder (SWD). Read Less

Hypertensive disorders (HD), including preeclampsia, gestational hypertension, chronic hypertension, and chronic hypertension with superimposed preeclampsia, affect around 10-20% of pregnant women in the United States and are significantly associated with maternal mortality and morbidity, particularly in the postpartum period. The prevalence of HD is on the rise in the United States and has increased from 13% in 2017 to 16% in 2019 owing to an increase in advanced maternal age, obesity, and diabetes. There are major racial disparities in HD and subsequent maternal mortality and morbidity. HD affect more than 1 in 5 delivery hospitalizations of Black women. Black women with HD are also more likely than white women with HD to have more adverse postpartum blood pressure trajectories which leads to a higher incidence of hypertension related hospital readmissions (readmission for hypertension during the first 6-weeks postpartum: 16.9% among Black women vs. 9.5% among white women, p=0.02) and cardiovascular-related adverse events. However, most of the management recommendations have been centered around blood pressure targets during the antepartum period with significantly less attention paid to the postpartum period despite evidence showing that hypertensive disorders are the most common reason for postpartum readmissions and are associated with increased maternal mortality and morbidity and a significant cost burden. Read Less

This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems. Read Less

Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by The World Health Organization. Another acute morbidity is anemia in preterm infants due to the prematurity and frequent laboratory testing. Anemia requires correction with a packed red blood cells (PRBC) transfusion. Researchers have previous noted hypothermia during PRBC transfusions in preterm infants. Objective: To use a commercial blood warmer in the neonatal intensive care setting to prevent hypothermic body temperatures (\<36.5°C) in very preterm infants during PRBC transfusions. Process: Based on a completed national survey of neonatal intensive care nurses and PRBC transfusion practices and personal NICU experience, we designed this randomized control trial in 140 very preterm infants in a Southeastern, level III neonatal intensive care unit. Outcomes: Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a lower incidence of central body hypothermia post transfusion (temperatures \<36.5C), compared to infants receiving PRBC transfusions by standard of care. Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a higher post transfusion mean abdominal skin body temperature when compared to infants receiving PRBC transfusions by standard of care. Hypothesis : The results of this trial could show that very preterm infants experience hypothermia during PRBC transfusions, and thus provide the evidence to support the need for warmed PRBC transfusions in very preterm infants nationwide. Read Less

The purpose of this study is to investigate the effects 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 physical performance metrics, body composition, and mental and physical readiness of tactical personnel. Read Less

The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and implementation of community-delivered, 3-month NEW Soul program among participants (N=228). Using a randomized design, the investigators will assess effectiveness of two delivery approaches: (1) In-person, live weekly classes with restaurant vouchers (intervention) or (2) restaurant voucher-only (active control). The investigators will also conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher-only with the outcome of cost/change in weight, healthy eating index, and quality adjusted life year. Lastly, the investigators will examine the implementation of the NEW Soul study with participants and intervention staff. Read Less

Our intent is to establish the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN) as a prospective, international cohort of minimum 5,000 men with advanced cancer, including men with mHSPC and M0/M1 CRPC. The goal is to establish a population-based registry and recruit patients across academic and community practices from Australia, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, Spain, South Africa, Sweden, Switzerland, the United Kingdom (UK), and the United States (US). Target accrual number and number of participating sites are subject to change based on accrual, funding, and interest in participation by other international sites. This cohort study will facilitate a better understanding of the variation in care and treatment of advanced prostate cancer across countries and across academia and community based practices. Detailed data will be collected from patients at study enrollment and then during follow-up, for a minimum of five years. Patients will be followed prospectively for overall survival, clinically significant adverse events, comorbidities, changes in cancer treatments, and PROMs. PROMs questionnaires will be collected at enrollment and every three months thereafter. Physician Questionnaires will be collected from all participating sites at patient enrollment, time of first change in treatment and/or one year follow-up, at each subsequent change of treatment, and discontinuation of treatment. As such, this registry will help identify the treatment sequences or combinations that optimize overall survival and PROMs for men with mHSPC and M0/M1 CRPC. By collecting blood at enrollment, time of first change in treatment and/or one year follow-up (plasma, cell free DNA, buffy coat / RNA), this registry will further identify and validate molecular phenotypes of disease that predict response and resistance to specific therapeutics. Additionally, every effort will be made to collect blood specimen at each subsequent change in treatment due to progression of disease. When feasible, existing tumor tissue may be collected for correlation with described blood based studies. All samples will be used for future research. This cohort study will provide the research community with a unique biorepository to identify biomarkers of treatment response and resistance. Read Less

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD. Read Less