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NCT00521989
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA. It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.
NCT01508026
To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.
NCT01659814
The overall aim of this study is to utilize an integrative research model in order to dynamically assess reward-related dopamine (DA) transmission in major depressive disorder (MDD) and test the role of dysfunctional DA release in depression and anhedonia. The first arm of this line of research (PET scan) aims to investigate phasic DA release in MDD during incentive motivation. The investigators will utilize an established molecular imaging technique to measure striatal DA release dynamically during performance of testing and control versions of a monetary incentive delay task, which involves anticipation and receipt of monetary rewards. In doing so, this experiment will link together independent lines of research that have associated depression with decreased hedonic responsiveness, impaired reinforcement learning and dysfunctional DA transmission. We hypothesize that, relative to matched controls, unmedicated MDD subjects will show reduced reward-related ligand (11C-raclopride) displacement. Reduced ligand displacement will be interpreted as indicating reduced task-induced release of endogenous striatal DA in response to reward-predicting cues and unpredictable reward in MDD subjects. In the second arm of this research (EEG recording), the investigators aim to probe the spatio-temporal dynamics of brain mechanisms underlying positive and negative reinforcement learning in MDD and their relations to phasic DA. Participants will perform the probabilistic stimulus selection task (PSST) while event-related potentials (ERPs) are collected. The investigators expect that, relative to matched controls, unmedicated MDD subjects will show reduced positive reinforcement learning, potentiated negative reinforcement learning, and larger (i.e., more negative) feedback-related negativity (FRN) in response to positive reinforcement (indicative of reduced DA transmission). Moreover, the investigators hypothesize that a more negative FRN in response to positive reinforcement will be associated with decreased striatal raclopride displacement (i.e., lower release of endogenous DA) as measured by PET in the first part of the study. This experiment will investigate the effects of blunted DA transmission on behavioral and ERP markers of both positive and negative reinforcement learning.
NCT00183755
This study will examine brain responses associated with reinforcement and reward tasks in individuals with major depressive disorder (MDD).
NCT01398761
The purpose of this grant is to fund the research necessary to fully understand the impact of this sign-out tool on clinician workflow, quality of sign-out, and continuity of care. This information will inform exactly how Partners will move ahead with tools to improve handoffs in care (i.e., whether the prototype will be adapted further, adopted Partners wide, or abandoned in favor of other solutions). The investigators hypothesize that a web-based handoff tool improves provider satisfaction, the quality of written sign-outs, and measures of continuity of care compared with current handoff tools.
NCT00113295
The purpose of this study is to examine the safety and efficacy of quetiapine for generalized anxiety disorder patients who remain symptomatic despite treatment with paroxetine CR.
NCT00385632
The purpose of this study is to compare the effects of two different anti-HIV drug regimens on quality of life and health care utilization among SMART study participants.
NCT00381303
The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of \< 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
NCT01215955
Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.
NCT00946569
The purpose of this study is to evaluate the safety and effectiveness of once daily oral administration of JNJ-39758979 in the treatment of adults (18 to 65 years of age) with persistent asthma.
NCT00086684
The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.
NCT01073163
The primary objective of this study is to assess the effect of treatment with bendamustine on cardiac repolarization as reflected by the rate-corrected QT interval by the Fridericia method (QTcF).
NCT01073228
This study is being conducted to determine the safety and effect on cognitive function of the investigational medication, EVP-6124, in individuals with mild to moderate probable Alzheimer's disease.
NCT00643201
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
NCT00868699
This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression
NCT00044512
Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.
NCT00968851
This study is being conducted to determine the safety and effect on cognitive function of two different doses of an investigational medication, EVP-6124, in individuals with schizophrenia who are on chronic stable atypical anti-psychotic therapy. In addition, behavioral and psychotic symptoms will be evaluated.
NCT01281839
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.
NCT02118207
SCUBA diving frequently involves repetitive exposures over multiple days. The goal of this study was to see how exercise impacts microparticles (MPs), endothelial function, and venous gas emboli (VGE) over a series of dives. 16 divers in 2 groups each completed 6 dives. One group completed 3 control dives followed by 5 days rest then 3 dives preceded by exercise. The other group completed the opposite protocol. Flow-mediated dilation (FMD) data and blood for MP analysis was collected before and after each dive. VGE were monitored via transthoracic echocardiography 30, 60, and 90 min after surfacing. Exercise before diving consisted of 60 min running outdoors including 8x4 min intervals at 90% VO2max effort.
NCT01000311
This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.