Durham, NC Paid Clinical Trials

This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss. Read Less

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality). Read Less

This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group. Patients in the sling group will wear a sling for three weeks after their surgery while the no sling group will only wear a sling three days after their surgery. Patients will follow their doctors normal follow up visit schedule after surgery, with visits at 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years. Read Less

OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol. After the child/adult (\<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected. Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system. Read Less

This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers. The goal is to create a robust resource for various research objectives, including studying the impact of variations in donor and medical practices on clinical outcomes. The project also seeks to identify serum biomarkers associated with or predictive of specific post-transplant complications and conditions. Read Less

Smoking is the leading cause of preventable illness, disability, and death in the United States. The rate of smoking is disproportionately higher among Veterans with posttraumatic stress disorder (PTSD). Unfortunately, smoking cessation efforts that are effective in the general population have shown limited effectiveness in smokers with PTSD. The high smoking rate and difficulty with achieving abstinence indicate a critical need to develop effective interventions for Veterans who smoke and have PTSD. The investigators' data indicate that negative emotions and trauma reminders are associated with relapse for smokers with PTSD. In this context, an ideal strategy may be to combine evidence-based PTSD treatment with intensive smoking cessation treatment to maximize quit rates. Cognitive processing therapy (CPT) is a well-established evidence-based treatment for PTSD. The investigators have successfully developed a treatment manual that combines CPT with cognitive-behavioral counseling for smoking cessation. Contingency management (CM) is another intensive behavioral treatment that has been shown to help with reducing smoking. CM provides positive reinforcers such as money to individuals misusing substances contingent upon abstinence from use. The primary goal of this study is to evaluate the efficacy of a treatment that combines CM with cognitive-behavioral smoking cessation counseling, smoking cessation medication, and CPT. Proposed is a randomized, two-arm clinical trial in which 120 Veteran smokers with PTSD will be randomized to either: 1) COGNITIVE PROCESSING THERAPY with SMOKING ABSTINENCE REINFORCEMENT THERAPY (CPT-SMART) or 2) COMBINED CONTACT CONTROL, an intervention identical to CPT-SMART in PTSD and smoking treatment, except for using payment that is not contingent on abstinence. Specific aims include: AIM 1) To evaluate the efficacy of CPT-SMART on rates of short- and long-term abstinence from cigarettes; AIM 2) To evaluate the impact of CPT-SMART on treatment engagement and utilization; and an EXPLORATORY AIM) To explore mechanisms of CPT-SMART on long-term smoking abstinence. The positive public health impact of reducing smoking among Veterans with PTSD could be enormous as it would prevent significant smoking-related morbidity and mortality. Read Less

Chlorhexidine gluconate (CHG) bathing is an effective intervention to reduce hospitalized patient's risk of acquiring a central line-associated bloodstream infection (CLABSI). While daily CHG bathing for hospitalized patients is widely supported in the literature, patient adherence with this practice is suboptimal. Written and verbal information is provided to patients by nursing staff regarding the importance of CHG bathing and the correct usage of the CHG cloths; however, these methods can be hindered by literacy and language barriers. Medical videos have become popular avenues to provide necessary education to patients, and have been shown to improve patient-reported outcomes. Whereas the benefits of educational videos has been described in previous studies on advanced care planning and postoperative quality of life, they have not been described for CHG bathing. In this study, we aim to provide education (including the rationale/importance of CHG bathing, and the appropriate process for bathing) through the use of a short video provided to hospitalized patients. The purpose of this study is to evaluate the use of medical videos to educate patients on CHG bathing while hospitalized in the inpatient setting. Read Less

The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision-makers often experience lasting psychological distress from the ICU experience. We will conduct a multicenter randomized trial among 370 incapacitated, critically ill older adult patients at high risk of death or severe functional impairment, their surrogate decision-makers, and their ICU clinicians to determine whether a multi-component family support intervention can improve the patient- and family-centeredness of care (primary outcome), as well as positively impact a variety of other patient, family, and healthcare delivery outcomes. The multicomponent intervention involves: Proactive family meetings scheduled within 48 hours of ICU admission and approximately every 5-7 days after that. Surrogates will have access (computer, tablet, or mobile phone) to the interactive web-based Family Support Tool. The tool will familiarize families with the ICU and prepare them for their interactions with the clinical team by completing specific sections of the Family Support Tool upon study enrollment, before family meetings, and any other time they wish. The ICU team will receive a tool-generated summary of information about the family before each family meeting, including their main questions and concerns, information about the patient's values and preferences, prognostic expectations, and unmet psychological needs. Read Less

This study is a prospective, randomized clinical trial. During this study,pregnant participants will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart). All participants will receive an mRNA COVID-19 vaccine at Visit 1 (Day 1). Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries, depending on study participant preference. Serious adverse events (SAE) and adverse events of special interest (AESI) will be collected throughout the duration of the study. Pregnant people will be followed through delivery with comprehensive obstetric and infant outcomes obtained from medical record review for 90 days post-delivery. Maternal serum samples will be collected for antibody titers relevant to Influenza and COVID-19 prior to vaccination, at Day 29 (both groups), as well as Days 36-43 if in sequential group. When feasible, maternal blood at delivery and cord blood serum will be analyzed for serological analyses of placental influenza and COVID-19 antibody transfer (cord blood: maternal antibody ratio) will be determined. Read Less

This Phase 1 dose escalation trial will assess the safety and preliminary efficacy of a single dose intravenous infusion of RP-A601 in high-risk adult patients with PKP2-ACM. Read Less

The primary objective of this study is to estimate the proportion of major congenital malformations in infants of women with migraine exposed to erenumab-aooe during pregnancy compared to infants of women with migraine unexposed to erenumeb-aooe. Read Less

The purpose of this feasibility study is to compare the impact of Spinal cord stimulation \[SCS\] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 12 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy. Participating subjects will be randomly assigned to one of two treatment groups: 1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation. 2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation \[SCS\]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation). For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm. At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 12 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits. Read Less