11 results
PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…
The primary efficacy objective is to evaluate whether LMWH is superior to VKAs in the long-term treatment of symptomatic VTE in cancer patients who completed 6 to 12 months of anticoagulant treatment. Two aspects are important: the efficacy with…
The primary objective of the study is to determine the rate of majorbleeding events in cancer subjects receiving extended treatment withdalteparin (> 6 months and up to 12 months) for prevention ofrecurrent symptomatic venous thromboembolism…
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH compared with dalteparin for theprevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects…
To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia and recurrent miscarriage on live birth.
Objective: Adequate analgesia during intravenous cannulation.Hypothesis: Xylocaine spray for the placement of an infusion decreases the pain score with two or more points in comparison to placebo spray.Studie questions:Primary: Has xylocaine spray…
Objective: Adequate analgesia during intravenous injections.Hypothesis: Xylocaine spray for the placement of an infusion decreases the pain score with two or more points in comparison to placebo spray.Studie questions:Primary: Has xylocaine spray an…
The proposed study is designed to test the hypothesis that the combination of anticoagulants, in particular Dalteparin plus Sunitinib, can be safely administered in a phase I feasibility trial in patients with renal cell cancer in which Sunitinib…
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
The primary objective of this study is to:* To determine the PD profiles for treatment doses of dalteparin in pediatric subjects of different ages with or without cancer and VTE, using anti-Xa levels and a population PD analysis methodology;* To…
The primary objective of this study is to assess whether abelacimab is non-inferior to dalteparin for preventing VTE recurrence through 6 monthspost randomization in patients with GI or GU cancer and recently diagnosed VTE. If non-inferiority is…