Healthy Paid Clinical Trials in North Carolina

MASKOFF Clinical Trials 8/22/23 Brief Summary: Purpose: The study is designed to investigate cardiovascular effects of young healthy human subjects exposed to wood smoke. Participants: Approximately 80 young (18-35 years old) healthy subjects to complete. Procedure (methods): After consenting to participate in the study, subjects will be exposed first to filtered air and on the next exposure day to approximately 500 µg/m^3 wood smoke. Both exposures will be 2 hours long with alternating 15 min of exercise (cycle ergometer) and 15 min rest period. The exercise level will be adjusted to achieve approximately 12 L/min/m^2 minute ventilation. Venous blood samples and measurements of lung, cardiac and vascular function will be made prior to and immediately following each exposure. Induced sputum samples and nasal epithelial lining fluid will be collected approximately 24 hours post each exposure. Read Less

Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit in the form of weekly grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk. Read Less

The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents. The study duration will be up to 12 months for all participants. Read Less

Primary Objective: To assess the safety and tolerability of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers. Secondary Objective: To characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Liposomal Bupivacaine 13.3 administered as a single intrathecal injection in healthy volunteers. Read Less

The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization. Read Less

This study will randomly assign 2,300 older adults on waiting lists at nine Meals on Wheels programs in Florida, Texas, North Carolina, South Carolina, and California into two groups who will receive: (a) daily delivery of meals, five days a week or (b) a shipment of 10 frozen meals, every two weeks. Researchers will examine participants' Medicare claims to understand if differences in healthcare utilization occur between the two groups within six months after they start receiving meals. Researchers will also ask participants questions prior to receiving meals, and again at three months, to understand how meals impact their ability to obtain food, their feelings of loneliness, and their overall quality of life. The primary study outcome will be the ratio of days spent in institutional settings (i.e., hospital, nursing home) in the six months after participants begin receiving meals. The secondary outcomes include the ratio of days spent in institutional settings in the three months after participants begin receiving meals, food insecurity, subjective isolation/loneliness, and health-related quality of life. The team will also examine differences in dietary intake between the two groups as an exploratory outcome. Read Less

The SKyRoCKeT Study (Surface-Knit and Reformulate CADENCE-Kids for Translation) will recruit a sex- and age-balanced sample of 360 young people 6-20 years of age to develop an integrative, physiologically-coherent age-cadence-log(metabolic equivalent, MET) surface-based model, reformulate the prior R21 CADENCE-Kids study (1; NCT01989104) by providing individualized, more precise, age-specific and coherent cadence-intensity thresholds, investigate additional differences by anthropometric factors, and translate cadence-intensity thresholds to over-ground walking. The SKyRoCKeT Study is an innovative critical step to provide a coherent, interpretable, objectively monitored step-based intensity metric to inform (inter)national physical activity (PA) guidelines by transforming currently vague guidelines of PA intensity into quantifiable PA recommendations that can be of widespread use, which clinicians, young people, parents, and researchers can integrate into preventive care management and action plans for personalized care. The SKyRoCKeT Study will allow for a user-friendly, interpretable metric to more accurately inform public health/behavioral interventions, assessments, analyses, school-based health and physical education curricula and programs, and public health messages for young people and their caregivers. Read Less

This is a research study to determine if a particular method of providing nutrition improves the clinical outcomes of patients in the intensive care unit (ICU) who have undergone abdominal surgery and would require nutrition delivered via the bloodstream (called total parenteral nutrition or TPN). The nutrition method we are testing is a structured nutrition delivery plan that involves tube feeding, oral nutrition supplements, and the use of a device (called an indirect calorimeter or IC) to measure calorie needs. This study will also use two devices to measure fat and muscle mass to examine changes during hospitalization. Subjects will be followed throughout hospitalization where nutrition status and fat and muscle mass will be closely monitored. Study activities will begin within 72 hours of a patient's abdominal surgery. TPN (total parenteral nutrition, a method of feeding that bypasses the usual process of eating and digestion) will be started, a non-invasive method of assessing calorie needs (indirect calorimetry (IC)) will be started, a urine sample will be collected to help assist in protein needs, and fat/muscle mass will be measured using bioelectrical impedance analysis (BIA), and an ultrasound. This is a minimal risk study and all products/devices used are non-invasive and FDA-approved. Indirect calorimetry and urine sample collection will be conducted every 3 days during the stay in the Intensive Care Unit - ICU, then every 5 days until hospital discharge. BIA and muscle ultrasound will be conducted every 7 days during ICU stay, then every 14 days until hospital discharge. Read Less

The goal of this randomized counterbalanced repeated measures study is to test beet-root juice supplementation and red light therapy augment forearm muscle endurance in apparently healthy older adults over 65 years of age. The main questions seek to answer the following question: Does beet-root juice supplementation improve forearm muscle endurance compared to a placebo supplement? Does red light therapy improve forearm muscle endurance compared to a sham light exposure? Does beet-root juice supplementation in combination with red light therapy improve forearm muscle endurance compared to a placebo-sham light control? Read Less

This research involves feasibility testing of design concepts to support device development of an electric breast pump. The purpose is to evaluate a prototype device for feasibility purposes and not health outcomes. Read Less

The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies. Read Less

The goal of this study is to determine the appropriate target of medically tailored meals (a particular individual vs. the entire household) and means of delivery (a dedicated delivery driver vs. a commercial shipper), to inform subsequent medically tailored meal trials. Read Less