15 results
The primary objective of the proposed feasibility study is to determine the willingness of patients to be randomized to CLI or DBS. Furthermore it will serve as a pilot trial for a future larger randomized controlled trial. For this larger trial,…
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…
Objective: Primary objective: safety profile of LEV in neonates. Safety outcome parameters as liver, kidney and metabolic function, electrolytes, hemodynamic effects (heart rate/arrhythmia, arterial blood pressure/hypotension). Investigation of…
Comparison of single-dose pharmacokinetics of levetiracetam after rectal versus oral administration at healthy volunteers.
The objective of the study is to realize an efficient allocation of resources to the available treatment options in advanced PD, while guaranteeing the highest standard of care.Secondary objectives are 1) to quantify the need for and cost of…
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…
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…
The primary objective of the clinical part of EPISTOP project is to identify the clinical and molecular biomarkers of epileptogenesis in a prospective clinical study of patients with TSC. Secondary objective of the clinical part of EPISTOP is to…
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…
To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia and recurrent miscarriage on live birth.
Primary Objective: To assess whether early postoperative AED withdrawal improves cognitive function compared to late withdrawal.Secondary objectives: * To confirm safety of earlier AED withdrawal; we will assess eventual seizure freedom, seizure…
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…
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…
Primary Objective- To investigate the ability of TMS-EEG measures to detect effects on cortical excitability of valproic acid, levetiracetam and lorazepam in healthy subjects- To investigate the ability of TMS-EMG measures to detect effects on…
- To evaluate effects of levetiracetam 2000 mg on single and paired pulse TMS-EMG and TMS-EEG in patients with epilepsy treated with mono-therapy levetiracetam, when compared to placebo (levetiracetam trough concentrations). - To evaluatethe effects…