159 results
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
To study the effects of ARA290 on the cognitive and neural processing of emotions in healthy volunteers 7 days post-administration.
To evaluate the efficacy and safety of nilotinib in spondyloarthritis
Hypothesis: PLS will improve speech understanding in noise in comparison to HiRes, an exisiting state-of-the-art speech coding strategy. The objective is to test this hypothesis. A secondary hypothesis is that PLS improves pitch perception. A…
Primary Objectives:• show effectiveness of the SMSC instrument in 3D correction of the spine prior to placement of the implants.The hypothesis is that to achieve de-rotation of the spine without failure of the pedicle screws, de-rotation has to be…
The primary objective for this study is to compare the safety, tolerability and analgesic efficacy of ABT-110 administered subcutaneously (SC) once every 8 weeks (q8w) for a total of 2 doses to placebo in subjects with pain due to osteoarthritis (OA…
To increase progression-free survival at 3 months.
Primary Objective• To evaluate best overall response rate (BORR; CR + PR) in Cohort 1 (TKI-naïve patients).* BORR will be based on investigator assessment, based on the findings on computed tomography (CT) or magnetic resonance imaging, using RECIST…
Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…
The primary objective of this study is to monitor the safety and tolerability of PF 00547659 during long term treatment. Secondary objectives: * The secondary objective is to assess pharmacokinetics and immunogenicity of PF 00547659.* Exploratory…
The aim of this project is to evaluate the clinical value of biomarkers in adult patients with pulmonary hypertension, in particular:1) To quantify biomarkers of neurohormonal activity as NTproBNP, endotheline-1 and of immunological activity as CRP…
Primary Objective:• To determine the safety and feasibility of intracoronary allogeneic, immuno-selected, bone marrow-derived Stro3 MPC delivery in the treatment of subjects with STEMI undergoing PCI of the LAD coronary artery.Secondary Objectives…
The primary objectives of this study are: • To determine the longterm safety and tolerability of rhHNS administered via an intrathecal (IT) route once monthly for 8 years in patients with MPS IIIA, who have received and tolerated 6 months of…
The aim of the trial is to obtain data on the optimal dose, feasibility and pharmacokinetics of bumetanide when given as an add-on treatment for seizures in full term babies with hypoxic ischemic encephalopathy (HIE). Bumetanide will be given in a…
The primary objective of this study is to demonstrate whether the MiStent Drug Eluting Coronary Stent System can safely and effectively improve coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo…
The primary objective of this study is to evaluate tolerance of a new high-energy high-protein oral nutritional supplement compared to a commercially available high-energy high-protein oral nutritional supplement in elderly subjects in need of oral…
The primary objective of the Phase 2 part of the study is to determine if overall survival(OS) in patients with Stage II-IV unresectable pancreatic cancer administered LY2603618 and gemcitabine combination therapy exceeds gemcitabine monotherapy OS.…
To determine the safety and efficacy (in increasing insulin sensitivity) of TRC 150094 once daily dosing for 4 weeks in male subjects with increased cardiometabolic risk.To evaluate the effect of TRC150094 on hepatic fat and metabolic parameters.To…
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2.1 Primary objective * To determine the feasibility (as measured by non-relapse mortality after 7 months) of the regimen of Ibritumomab, followed by a reduced intensity, partial T cell-depleted allogeneic stem cell transplantation and…