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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.
NCT02188719
The purpose of this study is look at the safety of: * Taking a specific combination of immunosuppressant drugs after liver transplantation * Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells (darTregs) while taking this specific combination of drugs
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.
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.
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.
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.
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).
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.
NCT02677727
This is a prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20 instrument. Approximately 60 patients will be collected for this study. The duration of this study will be up to 18 months for each patient. This study will complement a current R01 funded trial (Platinum Study) which evaluates the genetic predisposition of chronic neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a similar patient population, it does not evaluate the natural history of platinum induced neuropathy during active treatment and the first 12 months post chemotherapy. This trial will fill this gap and add to the investigators knowledge for both natural history and genetic predisposition of platinum neurotoxicity.
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.
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.
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.
NCT04222244
Neck pain, neck muscle weakness, and limited neck range of motion have been shown in individuals with sinus headaches. Individuals in this previous study self-diagnosed their sinus headaches. It is unknown whether or not individuals who have been diagnosed with sinus headaches according to diagnostic criteria also present with musculoskeletal impairments. The purpose of this study is to determine if musculoskeletal neck impairments are present in individuals diagnosed with headaches attributed to rhinosinusitis compared to people without headaches. Upper cervical range of motion can be measured using different tests. The side bend rotation test has been suggested as potentially more useful than the flexion rotation test in individuals with hyper-laxity, however, has not been examined in a symptomatic population. A secondary purpose is to compare the side bend rotation test to the cervical flexion rotation test in people with varying degrees of joint laxity.
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.
NCT01219699
This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for whom no standard therapy exists. A combination of BYL719 with fulvestrant will also be investigated in post-menopausal patients with locally advanced or metastatic breast cancer whose tumors have an alteration of the PIK3CA gene. The single agent MTD dose expansion cohort and the fulvestrant combination MTD dose expansion cohort will also include ER+/HER2- breast cancer patients whose tumors have the wild type PIK3CA gene
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.
NCT03337490
This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.
NCT02100748
The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain after bunionectomy.
NCT01196208
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001