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Discover 9,731 clinical trials near North Carolina. Find research studies in your area.
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NCT03887455
This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.
NCT06729606
This study looks at the safety and effectiveness of Aviptadil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.
NCT07214610
Phase 4 of the Carolina Breast Cancer Study (CBCS4) builds on prior phases that examined molecular and epidemiologic differences in breast cancer types and outcomes. Previous findings showed that certain breast cancer subtypes and genetic factors are linked to higher risks. While prior research uncovered subtype-specific risks and relevant genetic loci, persistent disparities especially among African American (AA) and American Indian/Alaska Native (AIAN) women suggest that tumor biology alone does not fully explain outcome differences. Other important factors, like access to healthcare, treatment adherence, patient engagement must also be evaluated. In addition to collecting biological and clinical data, participants will receive a structured behavioral intervention designed to improve communication with providers and self-advocacy during cancer care. This phase includes a structured behavioral intervention designed to improve health communication and self-advocacy, both of which are hypothesized to improve health outcomes. All participants are prospectively assigned to this single-arm intervention, which includes educational resources, symptom reporting tools, reflective self-assessments, and regular engagement with trained study staff over a defined timeline. This study assesses whether structured research participation can positively influence patient behavior and ultimately reduce disparities in breast cancer care. This study also aims to better understand etiology and prognosis of breast cancer, including subtypes such as Luminal A and B, Basal-like, and Human Epidermal Growth Factor Receptor 2 positive (HER2+) / estrogen receptor negative (ER-) and to address disparities driven by both biology and systemic barriers.
NCT07068477
The primary purpose of this study is to evaluate the effect of values assessment tool on patient and caregiver perception of decisional conflict, and communication with their oncology clinician.
NCT07065331
The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 administered in adolescent participants with asthma as well as the safety and performance of the dry powder inhaler.
NCT05370521
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
NCT05932615
The objective of ENVISION is to evaluate the safety and effectiveness of the Navitor Transcatheter Aortic Valve Implantation (TAVI) System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will also evaluate the safety and effectiveness of the Navitor TAVI System in a valve-in-valve (ViV) application in patients with symptomatic heart disease due to failure of a surgical or transcatheter bioprosthetic aortic valve who are at high or greater surgical risk.
NCT04825223
Primary Objective: * To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-4 only), and with age-appropriated routine pediatric vaccines (for Stages 3-4 only) 1. To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents; 2. To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants; 3. To describe the safety profile of the SP MenB vaccine formulations, * when administered alone * when administered with MenQuadfiTM (MenACYW conjugate vaccine) * when administered with routine infant immunizations * To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines after the last dose of primary vaccination in healthy adults, adolescents, toddlers and infants, when administered alone, or concomitantly with MenQuadfi Vaccine or other routine vaccines, as measured by the serum bactericidal assay using human complement (hSBA) in the primary panel of MenB strains by Stage, by age group and by vaccine schedule Secondary Objective: * To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines at each timepoint in healthy adults, adolescents, toddlers and infants, when administered alone or concomitantly with MenQuadfi Vaccine or other routine vaccines as measured by hSBA in the primary panel of MenB strains by Stage by age group and by vaccine schedule * To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents) in Stage 1 and 2 after the last dose of the primary series in each group * To describe the persistence of immune response following primary series at D366, and immune response 1 month after a booster dose of the SP MenB vaccine given 1-year post-dose 1 (at D366) in a subset of adults and adolescents in Stage 2 who received SP MenB vaccine formulations, Bexsero Vaccine or Trumenba Vaccine as measured by hSBA in the primary panel of MenB strains by age group * To describe the immune response against meningococcal serogroups A, C, W and Y measured with hSBA in participants from each agegroup receiving MenQuadfi Vaccine
NCT05729373
A clinical study that will meaure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old. The study will be held in Approximately 50 global study centers and approximately 15 additional centers for a separate Japan population. Participation in the study can be up to approximately 12 weeks.
NCT05383274
Single-arm, prospective study assessing semen quality after treatment with the Optilume Urethral DCB in men between 22 and 65 years of age.
NCT04810078
The purpose of this study is to evaluate the drug levels, efficacy, safety, and tolerability of subcutaneous nivolumab versus intravenous nivolumab in participants with previously treated clear cell renal cell carcinoma that is advanced or has spread. The purpose of this study's substudy is to evaluate drug level biocomparability of subcutaneous nivolumab manufactured using two different manufacturing processes.
NCT05650229
The primary objective of the FALCON study is to evaluate the efficacy of KL1333 on selected disease manifestations of primary mitochondrial disease (PMD) following 48 weeks of treatment. This objective involves evaluating the efficacy of KL1333 versus placebo on fatigue symptoms and impacts on daily living as well as on functional lower extremity strength and endurance. Additionally, the study evaluates the safety and tolerability of KL1333.
NCT04856410
This study investigates the effects of extended-duration spaceflight (12-month International Space Station missions) on general cognitive performance (measured with the Cognition test battery), spatial cognition, structural and functional brain changes in general, and hippocampal plasticity more specifically relative to the shorter 6-month and 2-month missions.
NCT05902663
The goal of this non-interventional study (NIS) is to collect real-world data to describe the natural history of Netherton Syndrome (NS).
NCT06733441
The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.
NCT02290951
This study has two parts with distinct study objectives and study design. In part A, odronextamab is studied as an intravenous (IV) administration with a dose escalation and a dose expansion phase for B-NHL and CLL. The dose escalation phase for B-NHL and the CLL study are closed at the time of protocol amendment 17. In part B, odronextamab is studied as a subcutaneous (SC) administration with a dose finding and a dose expansion phase for B-NHL.
NCT04095234
The purpose of this study is to compare the long-term effectiveness of acupuncture versus massage in people living with advanced cancer. The study will test how the two approaches compare in helping people with pain and its related symptoms and improving quality of life.
NCT01908777
The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous transplantation.
NCT05429502
This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors, including medulloblastoma (MB), high-grade glioma (HGG), malignant rhabdoid tumors (MRT), and rhabdomyosarcoma (RMS).
NCT02500849
The purpose of the study is to evaluate the safety and feasibility of administering SB-728mR-HSPC after conditioning with busulfan.