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Discover 17,526 clinical trials near North Carolina. Find research studies in your area.
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NCT04667234
The primary objective of this study is to provide expanded access to and characterize the safety profile of Sotorasib in participants with previously treated locally advanced/unresectable/metastatic non small-cell lung cancer (NSCLC) with KRAS p.G12C mutation in a real-world setting.
NCT06571045
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME) In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.
NCT04476043
To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week open-label extension period. All eligible participants will be invited to continue treatment for an additional 48-week Long-term extension period (also open label).
NCT05555043
Introduction: In the US, 15 million root canal treatments (RCTs) are carried out annually. Success rates decrease with conventional chemo-mechanical root canal preparation techniques used on teeth with periapical radiolucencies associated with bacterial presence. New irrigation modalities, such as the GentleWave® System (GWS) and Waterlase iPlus® (WL), have been developed to overcome limitations and improve RCT success rates. Hypotheses: (1) GWS and WL provide superior clinical outcomes compared to conventional RCT using passive ultrasonic activation (PUI). (2) GWS and WL are acceptable treatment modalities for clinicians and patients. Aims: (1) Estimate probability of success of GWS, WL, and conventional RCT with PUI. (2) Evaluate clinician and patient experiences of the different techniques.
NCT04761822
Background: Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine. Allergic reactions range from mild to severe and include life- threatening anaphylactic reactions, although no deaths have been reported with either vaccine. This study is designed with two principal aims: * To estimate the proportions of systemic allergic reactions to the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine in a High-Allergy/Mast Cell Disorder (HA/MCD) population, and * If the risk in the HA/MCD is demonstrable, to determine whether the proportions are higher in the HA/MCD in comparison to a representative population without severe allergies or mast cell disorders
NCT04279522
The MOOD study will evaluate the safety and efficacy of a noninvasive, self-administered external Combined Occipital and Trigeminal Neurostimulation (eCOT-NS) treatment for Major Depressive Disorder (Relivion®DP). This is a prospective, multi-center, 2-arm randomized, double-blind, parallel-group, sham-controlled study. The study will include the following stages: 1. Screening, Eligibility evaluation and Randomization to Relivion®DP vs. Sham control (1:1 randomization) (Baseline - Day 0). 2. Daily treatment period: Active/Sham (Group A/B) treatment protocol (Baseline to end of 8 weeks). 3. Open label phase: Active treatment period of additional 8 weeks. After completion of the open label period the subject's participation in the study will be over.
NCT06840600
The goal of this experiment is to examine the impact of policy rationale on public support for prison nutrition standards. The main question this experiment aims to answer is: Does the rationale provided for a policy to improve prison nutrition standards impact public support for such a policy? Additionally, this experiment aims to answer: To what extent are participant demographic characteristics correlated with public support for prison nutrition standards?
NCT06303739
The goal of this clinical trial is to test how well psilocybin-assisted therapy works in treating people with depression. The main questions this study aims to answer are: * Does psilocybin with assisted therapy help improve symptoms for people with depression? * How long do the effects of this treatment last? Participants will: * Take part in a couple of screening and preparation visits. * Be given psilocybin in one or two treatment sessions. * Attend a series of follow-up sessions over the following year. * Complete forms and surveys to test how their symptoms have changed and what they thought of their experience. Researchers will also compare whether one treatment or two treatments help improve symptoms more for participants.
NCT04513912
The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
NCT04454463
The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.
NCT05142774
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.
NCT05316220
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon. This study will assess how safe and effective mesalamine delayed-release capsules are in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Delzicol (Mesalamine) is an approved drug being developed for the treatment of Ulcerative Colitis (UC). Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. Around 80 Pediatric participants aged 5 to 17 years with a diagnosis of UC will be enrolled in approximately 45 sites in the United States. Participants will receive oral mesalamine capsules twice daily for 26 weeks and followed for 30 days. 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 completing questionnaires.
NCT05135975
This study will expand the types of pediatric cancers being evaluated for response to cabozantinib. The current COG study is restricted to Ewing sarcoma, osteosarcoma, rhabdomyosarcoma, Wilms tumor, and a handful of uncommon tumors. The proposed study will extend this evaluation to tumors that have been shown to either express known targets of cabozantinib or with preclinical evidence of efficacy, including specifically neuroblastomas. These tumors have high morbidity and mortality, particularly in the relapse setting, and few or no proven therapeutic options. As such, evaluation of cabozantinib in these studies is warranted. The study hypothesizes that use of cabozantinib in patients with ultra-high-risk pediatric solid tumors with minimal disease burden, as defined in the inclusion criteria below, can prevent and/or slow recurrent tumor formation in pediatric solid tumors and thereby significantly extend the period of disease control and/or induce a durable cure.
NCT06503367
The goal of this observational study is to understand how young children with LAMA2-related dystrophy move and change over time. We will also learn about how this condition impacts other body systems. Participants will undergo: * Neuromuscular assessments * Blood collections * Swallowing and breathing assessments * Questionnaires
NCT03314935
The purpose of this open-label nonrandomized Phase 1/2 study is to evaluate INCB001158 in combination with chemotherapy in participants with advanced/metastatic solid tumors.
NCT06450925
The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.
NCT06213831
This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).
NCT06487962
Low-income adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to mitigate these inequities. To increase CGM uptake in low-income, adults with T1D receiving diabetes management in federally qualified health centers (FQHCs), this pilot randomized control trial (RCT), will assess the feasibility of our study protocol, including our multi-level intervention informed by the Socio-Ecological Model.
NCT04285086
This is a Phase 3 open-label, multicenter, randomized, active-controlled study designed to compare the efficacy and safety and tolerability of P1101 compared with ANA after 12 months of treatment as second-line therapy for subjects with ET who have had a suboptimal or failed response to HU.
NCT04016389
This study will include patients with invasive cervical cancer that wish to keep their fertility as much as possible in the future after treatment. Patients who receive surgery alone may experience long-term side effects including infertility. The purpose of this research study is to determine whether giving neo-adjuvant chemotherapy prior to surgery can maintain fertility in patients with invasive cervical cancer. The neo-adjuvant chemotherapy will consist of a platinum-based chemotherapy drug cisplatin or carboplatin, with a chemotherapy drug called paclitaxel. These are common chemotherapy drugs used in the treatment of women with cervical cancers.