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Discover 20,428 clinical trials near North Carolina. Find research studies in your area.
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NCT03116971
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.
NCT03389308
The primary objective of this study is to evaluate the long term safety and tolerability of diacerein 1% ointment for 2 treatment cycles in subjects with EBS that previously participated in the CCP-020-301 or the CCP-020-101 studies.
NCT03345901
Despite improved glycemic and systemic control for many patients with diabetes, over the past several decades, diabetic retinopathy (DR) develops and progresses in a large proportion of patients, and visual loss from diabetic eye complications continues to be a leading cause of blindness in the US and other developed countries worldwide. Thus, even a modest ability to prevent DR onset or to slow DR worsening might substantially reduce the number of patients at risk for diabetes-related vision loss worldwide. Widespread use of an oral agent effective at reducing worsening of DR might also decrease the numbers of patients who undergo treatment for DR and diabetic macular edema (DME) and who are consequently at risk for side effects that adversely affect visual function. Two major studies of fenofibrate, the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and The Action to Control Cardiovascular Risk in Diabetes (ACCORD)-eye study, have demonstrated clinically important reduction in progression of retinopathy in patients with diabetes assigned to fibrate compared with placebo. However, despite the positive clinical trial results, fenofibrate has not gained wide acceptance as a preventive agent by either ophthalmologists or primary diabetes care providers. Thus, it is important to provide further evidence demonstrating whether or not selectively increasing peroxisome proliferator-activated receptor alpha (PPARα) activity reduces progression of retinopathy in patients with diabetes and non-proliferative diabetic retinopathy at baseline. Pemafibrate is a more potent and selective PPARα modulator than fenofibrate. Its efficacy is currently being evaluated in the Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT) study for prevention of cardiovascular events in patients with type 2 diabetes. Given the large study cohort with a substantial proportion likely to have DR and the multi-year duration of the PROMINENT trial, this study represents a unique opportunity to assess effects of chronic PPARα activation through pemafibrate therapy on DR outcomes. Primary Study Objective: To assess whether treatment with pemafibrate (0.2 mg orally BID) compared with placebo reduces the hazard rate of diabetic retinopathy worsening in adults with type 2 diabetes and diabetic retinopathy without neovascularization in at least one eye who are participating in the parent PROMINENT trial.
NCT02016560
A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD).
NCT02441283
This was a long-term follow-up study to evaluate the durability of sustained virologic response (SVR), persistence of direct-acting antiviral agent (DAA) resistance, and clinical outcomes for participants who received glecaprevir (ABT-493) and/or pibrentasvir (ABT-530) in prior AbbVie Phase 2 or 3 clinical studies for the treatment of chronic hepatitis C virus (HCV) infection.
NCT02784444
This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.
NCT01989325
This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.
NCT02185794
The primary objective of the study is to evaluate the safety and tolerability of voxilaprevir (formerly GS-9857) alone or with sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) and antiviral activity of voxilaprevir in adults with genotype 1, 2, 3, 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48 weeks after the last dose.
NCT04018222
This study is investigating the development of a diagnostic test intended to predict flares in patients with Systemic Lupus Erythematosus. Over a six-month period, the participant will donate blood samples for researchers to evaluate the types of proteins that are in their blood. During this time the participant will also visit a research physician to undergo a physical exam that will include an evaluation of the disease's level of activity. Questionnaires will be answered too, either via email, phone call, or a research app for android and iPhone devices. During this six-month period, if the participant experiences a lupus flare, they are strongly encouraged to visit the research physician to receive a complimentary medical evaluation.
NCT02100748
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
NCT04258891
The incidence of end stage renal disease (ESRD) is rapidly increasing, now affecting an estimated 7.4 million people worldwide. Numerous parameters such as demographic, clinical and functional factors drive the deterioration of the kidney, ultimately leading to ESRD. Although some ESRD prediction models have been derived in the past years, none of these models are dynamic: they do not integrate the repeated measurements recorded throughout individuals' follow-up. As highlighted in several studies, kidney function repeated measurements (i.e., trajectories) are highly associated with graft survival after kidney transplantation. The investigators made the hypothesis that these trajectories may bring relevant information in the context of graft survival risk prediction model. Hence, combining these trajectories with standard graft survival risk factors may enhance prediction performance. This could permit to derive a robust tool that could be updated over time by continuously capturing patient' personal evolution.
NCT02059213
This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer. The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT.
NCT02264574
The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.
NCT02797743
This study will obtain whole blood specimens from healthy subjects to be used for research and development and clinical validation of genetic assays.
NCT01983501
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.
NCT03337490
This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.
NCT04043819
The objective of this clinical study is to evaluate the safety of an intraarticular injection of an investigational biologic product (IBP), PSC-01, the patient's own adipose-derived stromal vascular fraction cells (SVF) extracted from a lipoaspirate sample, to treat the pain of osteoarthritis in a single knee. The secondary objective is to get initial data on efficacy of the PSC-01.
NCT02864381
The primary objective of this study is to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.
NCT03090945
The goal of this study is to identify significant clinical and laboratory risk factors in pediatric patients with significant upper gastrointestinal bleeding. This is defined as bleeding that necessitates an upper endoscopic evaluation to either diagnose or treat upper GI bleeding during their hospital admission. If a predictive/risk stratification relationship exists, these data could permit a more effective triaging and intervention scheme in pediatric patients presenting with complaints of gastrointestinal bleeding. In addition we want to get a better understanding of the re-bleeding rate after endoscopic therapy for upper GI bleeding and if there are any identifiable risk factors for re-bleeding. Lastly we want to understand best practice management for upper GI bleeding.
NCT01196208
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001