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COOLing for Ischaemic Stroke Trial. A phase II randomised clinical trial.

To compare the feasibility and safety of surface cooling to 34, 34.5, and 35*C, started within 4.5 hours after the onset of acute ischaemic stroke and maintained for 24 hours, in awake patients on a stroke unit.

Preventive Swallowing Exercises to prevent persistent swallowing dysfunction after curative (chemo)-radiation in head and neck cancer

The proposed phase II study will test the hypothesis that preventive swallowing exercises (PSE) during treatment will reduce the incidence of swallowing dysfunction among patients with HNSCC treated with curatively intended (CH)-RT using SWIMRT. As…

Prospective, multi-center, randomized, heparin-controlled dose-finding trial to evaluate the efficacy and safety of rivaroxaban, a direct factor Xa inhibitor, on the background of standard dual antiplatelet therapy to support elective percutaneous coronary intervention (X-Plorer).

The aim of this study is to assess whether rivaroxaban, as compared to UFH, on the background of standard dual antiplatelet therapy (DAPT), can effectively suppress thrombosis, and related adverse ischemic events, upon balloon inflation and stent…

EVALUATION OF THE EFFICACY AND SAFETY OF 6 REPEATED DAILY
DOSES OF NEBULISED RPL554 0.018 mg/kg (6X)
IN ALLERGIC ASTHMATICS

To investigate the efficacy of repeated daily doses of nebulised RPL554 (0.018 mg/kg) by assessing the effect on FEV1 at day 1, 3 and 6 after daily inhaled doses of nebulised RPL554 0.018 mg/kg (6X) in 16 allergic asthmatics.

LUME-Lung 3. A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first line NSCLC patients with squamous cell histology.

Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…

Extension trial to evaluate long term safety of patients randomised into 1160.113 RE-ALIGN study
(RE-ALIGN-EX)

The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…

A randomized, double-blind, placebo-controlled, multicenter Phase II trial investigating two doses of EMD 525797 in subjects with asymptomatic or mildly symptomatic metastatic castrate-resistant prostate cancer (mCRPC).

The main objective of this study is to investigate of the drug EMD 525797 is better then no treatment with subjects with metastasized asymptomatic or mild symptomatic mCRPC. The efficacy and safety of the drug EMD 525797 is evaluated.Primary…

A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients with Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)

The primary objective of this study is to evaluate the tumor response of stable disease (SD), partial response, or complete response at at 12 weeks (according to RECIST 1.1 criteria) in two separate cohorts representing molecularly distinct subsets…

Can HDL Infusions Significantly Quicken Atherosclerosis Regression?
A phase II, Multi-center, double-blind, ascending dose, placebo-controlled, dose-finding trial of CER-001 or placebo in subjects with acute coronary syndrome.

To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.

A Randomised, phase II study to Evaluate the sAfety of oraL dabIGatran etexilate in patients after heart valve replacemeNt. (RE-ALIGN)

The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…

CT/MR guided cryoablation for painful bone metastasis: an observational trial.

The main objective of the study was to prove the effectiveness of cryoablation in palliating pain and correlate the patients with a matched group of the Dutch bone metastasis study. The secondary objectives are to determine the accuracy of cryoprobe…