16 results
Objectives:Primary:- To evaluate efficacy as measured by overall survival (OS), with a goal of demonstrating the superiority of inotuzumab ozogamicin when administered in combination with rituximab, compared with an active comparator arm.Secondary…
To define indications for recently developed, but more expensive, self-expanding metal stents (SEMS) versus cheaper plastic stents in patients with primary or recurrent inoperable malignant extrahepatic common bile duct (CBD) obstruction, based on…
Primary: to compare the efficacy and safety of once daily (evening) administration of FF/VI 100/25 with FF 100 in adult and adolescent subjects >= 12 years of age with moderate to severe, persistent bronchial asthma over 12 weeks.Secondary:…
The objective for the study is to establish a proof of concept for the use of self-expandable stenting in subacute to chronic total occlusions and evaluate the safety and effectiveness of the STENTYS Coronary Stent System in the treatment of these…
The primary objective is to assess the safety and operation of the Stentys coronary stent system in patients with acute myocardial infarction compared with a balloon-expanding stent. These are the effect and safety in the short term (the procedure…
The primary objective of the study is to quantitatively determine the pharmacokinetics (distribution, metabolism, and excretion) of [14C]bendamustine and its metabolites in patients with confirmed, relapsed or refractory malignancy (hematologic or…
To determine the safety and effectiveness of Boston Scientific*s Everolimus-eluting coronary stent system (PROMUS Element*) for coronary revascularization in an unrestricted population compared to the Xience* Prime control.
Primary: Efficacy of FF/GW642444 100/25 mcg once daily in comparison with that of FP/salmeterol 250/50 mcg twice daily during 24 weeks.Secundary: Safety and tolerability.
Efficacy and safety during 24 treatment weeks.
The primary aim of the proposed study is to assess whether stenting for symptomatic vertebral artery stenosis >= 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar…
The aim of this study is to determine safety, patency of placement and long term symptom-free outcome of a covered self expandable metal stent in patients with a benign CBD stricture.
Analyze the protective effect of intranasal corticosteroids against exercise induced upper and lower airway obstruction
The aim of this study is to determine safety, patency of placement and long term symptom-free outcome of a covered self expandable metal stent in patients with a benign CBD stricture.
Primary objective:- To assess safety, efficacy, and potentially select the most active treatment regimen among 3 treatment arms to advance to the Phase 3 component of the study.Secondary objectives:- Ph1b: evaluate PK & assess immunogenicity…
There are two treatment groups in this study: one with participants at low risk of deterioration and one with participants at standard risk of deterioration. The primary objective for each group is described below.-Low Risk group: To describe the…
To investigate the effect of microneedling on the patient overall opinion of the abdominal scar quality after a DIEP flap procedure comparing the treated part and the untreated part of the scar after 9 months of follow up.