North Carolina Paid Clinical Trials

The investigators will utilize a systematic approach for the diagnostic evaluation of patients to identify characteristics which may distinguish between Primary Immunodeficiency (PID) disorders versus Primary Ciliary Dyskinesia (PCD). Read Less

To conduct a randomized trial to determine the effect of Targeted Lifestyle Change Group Prenatal Care (TLC) on maternal and neonatal outcomes in women at high risk for developing gestational diabetes mellitus (GDM). Read Less

This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 45 ml/min/1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit. Read Less

The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor. 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

This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia. Read Less

The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with NKTR-255 and anti-PD1 therapy for subjects with refractory non-small cell lung cancer. The purpose of this study is to: 1. Test the safety and ability for subjects to tolerate the TIL therapy 2. Measure to see how the NSCLC responds to the TIL therapy Participants will be asked to: * Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051. * Receive standard of care treatment until their lung cancer no longer responds * When necessary, the C-TIL051 will be manufactured by the sponsor and sent back to the site * Subject will then receive chemotherapy (called lymphodepletion) for 3 days followed by 2 days of rest * C-TIL051 will then be infused on day 0 followed by NKTR-255 (IL-15) about 12 to 24 hours later * Pembrolizumab will be administered every 3 weeks for up to 2 years NKTR-255 is a novel polymer-conjugated human IL-15 receptor agonist molecule designed to increase the proliferation and survival of memory CD8+ T cells and enhance the formation of long-term immunological memory which may lead to sustained anti-cancer immune response. The combination of NKTR 255 and TIL's could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity. 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

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

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 main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT). 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