178 results
To evaluate whether SAH patients treated by state-of-the-art SAH management with additional ultra-early and short term TXA administration have a significantly higher percentage of favourable outcome after six months (score 0-3 on the Modified Rankin…
The primary objective is, in patients at low-density lipoprotein cholesterol (LDL-C) goal while on statin therapy, with established cardiovascular disease (CVD) or at high risk for CVD, and hypertriglyceridemia (fasting triglycerides [TG] *200 mg/dL…
Objectives: The primary objectives of the study are to assess whether 80 mg LY2439821 every 2 weeks (Q2W) or every 4 weeks (Q4W) is:* Superior to placebo at Week 12 in the treatment of patients with moderate-to-severe plaque Ps as measured by: o…
Primary: superiority of dabrafenib and trametinib combination therapy over vemurafenib monotherapy with respect to overall survival for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.Secondary: progression free…
Main Objective: To assess the effects of OCA in patients with PBC on: -Serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint -SafetySecondary Objectives:To assess the effects of OCA in patients with PBC on:-…
Primary Objective• To assess the safety and tolerability of long-term tofacitinib therapy in subjects with UC.Secondary Objectives• To evaluate the efficacy of long term tofacitinib therapy in subjects with UC.• To evaluate the effect of long term…
1. To improve the overall outcome as compared to the previous protocols of the DCOG, especially ALL-9 and ALL-10.This is aimed for by decreasing therapy for part of the patients (TEL/AML1, Down syndrome, PPR only), increasing therapy for IKZF1…
Primary Objective: Evaluate the safety of the combination of pomalidomide (POM) and low dose dexamethasone (LD-DEX) in a large cohort of subjects with refractory MM or relapsed and refractory MM.Secondary Objectives:- Analyze the population…
Primary Objective: Investigate whether early valganciclovir treatment of children with SNHL of >= 20 dB, unilateral or bilateral, and a confirmed congenital CMV infection can prevent deterioration of the hearing loss at 1 year follow-up.…
Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
The primary objective of this study is to provide access to SPD503 following participation in SPD503-315 or SPD503-316. The primary outcome of this study is to evaluate the long-term safety of SPD503. The evaluation of safety will be based on the…
Primary:The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects undergoing spine, liver, vascular or soft tissue surgery, when…
The primary objective of this study is to:• Evaluate the efficacy of ranolazine as compared with placebowhen used as part of standard medical therapy in chronicangina subjects with incomplete revascularization post percutaneous coronary intervention…
2.1 Primary study objectiveThe primary objective of this study is to investigate the therapeutic effect of an extensively hydrolyzed protein based infant formula with a synbiotic mixture on the severity of atopic dermatitis in infants.2.2 Secondary…
Improvement of the functional recovery of patients with a hipfracture and the prevention of re-surgery.
The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with FCS (HLP type I).
There is still no level I-II evidence for cytoreductive surgery in recurrent ovarian cancer. This is also the conclusion of a Cochrane Review of Galaal et al. published in June 2010. The most active chemotherapy in platinum sensitive recurrent…
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein (LDL) cholesterol (LDL-C) by REGN727 in comparison with ezetimibe (EZE) 10 mg PO QD after 24 weeks in patients with primary hypercholesterolemia (…
The primary objective of this study is to determine whether treatment with the RePneu LVRC System results in improved exercise capacity and quality of life, as measured by improvements in the 6 Minute Walk Test (6MWT).
The primary objective of this study is to evaluate the safety and tolerability of trastuzumab emtansine.