North Carolina Paid Clinical Trials

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks. Read Less

Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs. Read Less

The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data. Read Less

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. The study will be conducted in 3 parts: Part A (INX-315 monotherapy dose escalation and combination therapy with fulvestrant), Part B (ovarian cancer INX-315 monotherapy dose expansion), and Part C (INX-315 combination therapy with abemaciclib \[a CDK4/6i\] and fulvestrant \[a SERD\] in advanced/metastatic breast cancer; dose escalation and expansion). Read Less

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of ABBV-383 in adult participants with relapsed/refractory (R/R) MM. ABBV-383 is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 3 Arms; Arm A (Parts 1 and 2), Arm B and Arm C. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of ABBV-383. In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of ABBV-383. In Arm B a flat dose of ABBV-383 will be tested. "In Arm C, the step-up dose identified in Arm A will be used followed by the target dose of ABBV-383 to investigate outpatient administration of ABBV-383. Around 180 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 40 sites across the world. Participants will receive ABBV-383 as an infusion into the vein in 28 day cycles for approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires. Read Less

Posttraumatic stress disorder (PTSD) is a significant problem among underserved populations who receive care in community health centers. Several evidence-based psychotherapies for PTSD are not practical given the time and resources required for these approaches. This research will examine whether Written Exposure Therapy (WET), a brief and well-tolerated therapy approach, delivered within collaborative primary care is effective and can be implemented successfully within a collaborative care (CC) intervention. The primary aims of the proposed study are to evaluate the effectiveness and implementation of delivering WET into CoCM to improve the management of PTSD among underserved primary care patients in Federally Qualified Health Centers (FQHCs). Read Less

The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications. Read Less

Central centrifugal cicatricial alopecia (CCCA) is form of scarring hair loss that predominately affects middle-aged women of African descent.1 . Clinically, the natural progression of CCCA starts at the crown as roughly circular scarred patches, which evolve into scarred areas increasing in size circumferentially. Characteristically, the scar is often smooth and shiny, and the hair density in the affected area is frequently decreased. The hair remaining in the scarred areas is more brittle and shorter than the hair in unaffected areas. Since CCCA is a scarring disorder, it can cause permanent hair loss, dyesthesias, and psychological distress which can affect overall quality of life. Affected individuals may complain of pruritus, pain, or tenderness.2 The management of CCCA is challenging due to limited current treatments and a lack of randomized controlled trails. Management focuses on behavioral and styling modifications, in addition to symptomatic relief. Any potentially damaging hair care practices such as chemical relaxers, heat application to the scalp, and the use of hardening gels and sprays are discouraged.3 Many commonly used therapies are anti-inflammatory in nature, including intralesional steroids, topical steroids, oral antibiotics and increased frequency of hair washing with antidandruff shampoos.4 These treatments not only lead to improvement in pruritus and tenderness, but in some cases result in increased hair density.5 Since there is limited investigation done to determine the most effective treatment approach for CCCA subjects, it would be of great benefit to determine if there is any advantage in using one particular anti-inflammatory therapy over others and whether one is more efficacious in relieving symptoms or promoting hair regrowth in follicles that have not yet become scarred. The Revian Red All LED cap is a dual-band LED light therapy wireless "smart" cap. It has been effective in androgenetic alopecia (used once daily, 10-minute treatment regimen) for both men and women. There are also reportedly minimal side effects, unlike with topical minoxidil which can cause pruritus and initial hair shedding in the first few weeks, or finasteride which can cause gynecomastia and loss of libido. In this study we hope to see if the anti-inflammatory capabilities of this cap can improve scalp symptoms, reduce hair loss, and promote maturation of vellus and intermediate hairs in non-scarred areas of the scalp in those affected by CCCA. Read Less

The primary goal of this study is to examine whether recurrence of HPV-associated OPSCC can be predicted by two factors: 1) mutations in genes called TRAF3 and CYLD, and 2) measurements of circulating HPV DNA in blood plasma. The study will also investigate whether HPV integration is associated with TRAF3 and CYLD mutations, and whether recurrence prediction improves when looking at HPV integration along with TRAF3 and CYLD mutations. Read Less

This phase II trial investigates how well lisinopril may work in preventing the progression of non-alcoholic fatty liver disease (NAFLD). NAFLD is a condition where there is an accumulation of fatty cells in the liver. NAFLD increases a person's risk of developing liver cancer. Liver fibrosis is the common finding of chronic liver diseases leading to reduced liver function. Lisinopril is a medication that is commonly used to treat high blood pressure. Lisinopril may help to decrease liver fibrosis. The purpose of this trial is to find out what effect, if any, lisinopril has on a patient's risk of developing liver cancer. Read Less

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension Read Less

This study will be a prospective, observational study of patients who undergo endoscopic sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do not undergo surgery but are treated medically for CRS will also be enrolled to serve as a control group. Outcomes analyzed will include pulmonary, quality of life, and others. Read Less