Loading clinical trials...
Discover 9,710 clinical trials near Florida. Find research studies in your area.
Browse by condition:
Showing 6641-6660 of 9,710 trials
NCT01945866
Although anti-vascular endothelial growth factor (VEGF) therapy is generally effective as treatment for center-involved diabetic macular edema (DME), a substantial proportion of anti-VEGF-treated eyes with DME do not achieve vision of 20/20 or complete resolution of retinal thickening. Indeed, over 50% of ranibizumab-treated eyes did not achieve a 2 or more line improvement in visual acuity from baseline at 2 years in Protocol I, a previous DRCR.net (Diabetic Retinopathy Clinical Research Network) study. Furthermore, 27% of ranibizumab-treated eyes still had central subfield (CSF) thickness on time-domain optical coherence tomography (OCT) ≥ 300 at 1 year, and more than 40% of ranibizumab-treated eyes did not achieve complete resolution of retinal thickening (\< 250 microns) by 2 years. Thus, there is a need for alternative or additional treatments that will improve vision by reducing retinal edema in eyes with persistent DME following previous anti-VEGF therapy. Intravitreal steroid is not as efficacious as ranibizumab in eyes with DME overall, but it has been shown to have a positive effect for DME in some eyes and might add benefit in eyes that are already receiving anti-VEGF. The main objective of this study is to assess the short-term effects of combination steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF therapy alone in eyes with persistent central-involved DME and visual acuity impairment despite previous anti-VEGF treatment. This study will provide important information for the design of a future confirmatory phase III clinical trial on the efficacy of combination steroid and anti-VEGF in eyes with persistent DME and vision impairment following previous anti-VEGF therapy. The primary outcome for efficacy will be the mean change in visual acuity at 24 weeks. Each study eye is required to complete a 12-week run-in phase. The run-in phase will identify study eyes that truly have persistent DME despite anti-VEGF therapy by requiring an additional 3 injections while also collecting standardized visual acuity and OCT measurements. At the enrollment, 4-week and 8-week visits of the run-in phase, enrolled eyes will receive an intravitreal injection of ranibizumab 3mg. Then at the 12-week run-in visit, if the eye still has persistent DME, it will be randomized to receive either intravitreal sham+intravitreal ranibizumab 0.3 or intravitreal dexamethasone+intravitreal ranibizumab 0.3 injections. The randomized study duration is 24 week, during which a protocol visit takes place every month. The combination injections of sham+ranibizumab or dexamethasone +ranibizumab will be given at the randomization visit (baseline) and at the 12-week visit after randomization. In between, an intravitreal injection of ranibizumab only will be given to study eyes at the 4, 8, 16 and 20 week visits.
NCT02164513
The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid \[ICS\]/ Long-acting Muscarinic Receptor Antagonists \[LAMA\])/ Long Acting Beta-Agonist \[LABA\] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD
NCT00584051
Asthma is an inflammatory condition of the airways in the lungs that results in obstruction of airflow in those with the condition. The disease continues to be a major worldwide health care problem and its prevalence continues to increase annually. In 2005, 20 million people were diagnosed with asthma. The disease causes significant morbidity and accounts for 5,000 deaths annually. Between 1980 and 1994 the prevalence of asthma increased 74% in the United States and, in children under age 5, the prevalence increased by 160%. The allergic etiology of airway inflammation associated with asthma is established. Bronchial washings of asthmatic subjects are most often characterized by eosinophils, mast cells, and cytokines that are associated with the Th2 (allergic) phenotype. Similarly, IgE plays a pivotal role in airway inflammation of asthmatic subjects when allergens that cross-link IgE bound to mast cells in the airways cause the release of histamine and other inflammatory mediators. The association of asthma and the IgE mediated allergic phenotype is well established and up to 70% of asthmatics also suffer from allergic disease. Adequately treated asthma often has minimal impact of quality of life but diagnosis and proper treatment is often delayed, resulting in increased missed school days, emergency room visits, and otherwise preventable degradation in quality of life. It would therefore be highly useful to identify a biomarker that can be used to assist in the diagnosis of asthma or to identify subjects at higher risk of developing allergic disease or asthma in the future. Efforts at identifying a genetic marker for the early diagnosis of asthma have been unsuccessful, mainly due to the complexity of the pathogenesis of the disease. Atrial natriuretic factor is a pro-hormone precursor for 4 natriuretic peptide hormones including atrial natriuretic peptide (ANP). ANP's effects on the cardiovascular system are well characterized. Less well understood is the role these hormones play in immune regulation. Recent studies have demonstrated a role for ANP in the regulation of immune function: ANP induces release of histamine from mast cells and macrophages, stimulates migration of neutrophils, enhances the cytotoxic activity of natural killer (NK) cells, and stimulates TNF-β production. Human dendritic cells express ANP receptors (GC-a) which polarize CD4+ cells towards a Th2 phenotype. Since allergic rhinitis and asthma are associated with a Th2 phenotype, it is possible that elevated levels of ANP can be used to predict asthma severity or to predict future predilection to atopic disease. There are a number of ANP gene polymorphisms that have been studied and found to be associated with renal disease, heart disease, hypertension and diabetes. Several studies have investigated the potential role of these polymorphisms in cardiovascular disease and have found association between polymorphisms of the ANP gene and left ventricular remodeling, hypertension, renal disease, diabetes, and increased risk of ischemic stroke. To our knowledge, no studies evaluating the role of ANP polymorphisms in allergic disease have been performed. The goal of this research proposal is to evaluate whether ANP levels can be utilized to assist in diagnosis of asthma and in the prediction of asthma severity. Additionally, we will investigate the potential effect of polymorphisms in the ANP gene on asthma severity and thus serve as a useful genetic marker to predict future risk of atopy and asthma.
NCT01262365
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)
NCT02472184
This study will look at the optimal order in which to perform concurrent office hysteroscopy and endometrial biopsy in female patients who present for evaluation of abnormal uterine bleeding at a fibroid and endometriosis treatment center.
NCT00175825
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
NCT03120598
A cluster randomized experiment focused on testing the extent to which the organization-focused Implementation \& Sustainment Facilitation (ISF) strategy is an effective adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.
NCT01626456
This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.
NCT00430638
This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure.
NCT00712348
This is a multi-center, open-label, switchover trial to assess the safety of taliglucerase alfa in 30 patients with Gaucher disease who are currently being treated with imiglucerase (Cerezyme®) enzyme replacement therapy.
NCT01977573
This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
NCT01189864
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.
NCT00957723
The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.
NCT01543958
HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines. Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer carbonate decreases the inflammation endotoxin causes in dialysis patients. A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer carbonate administration on markers of microbial translocation and T-cell activation in the blood in chronically HIV-infected subjects not receiving ART.
NCT02653625
This is an open label, proof of concept (PoC) study of Cenicriviroc (CVC) in adult participants with Primary Sclerosing Cholangitis (PSC). The main objective of this PoC study is to assess changes in alkaline phosphatase (ALP) both individually and as a group, over 24 weeks of treatment with CVC.
NCT01739673
This study is to evaluate the efficacy of ultraviolet-A (UVA) and riboflavin application (also often referred to as corneal collagen crosslinking) as a method to enhance treatment of infectious keratitis.
NCT00705939
Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (GCD) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer) in the cells of the monocyte-macrophage system. This is an extension trial to Study NCT00376168 and NCT00712348.
NCT00526071
Study to evaluate the long-term safety, tolerability, and pharmacodynamics (PD) of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease
NCT00084136
This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.
NCT00231166
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.
