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Rheos(TM) Pivotal Trial, a Study of Baroreflex Hypertension Therapy in Refractory Hypertension.
Amendment 1: Dynamic cerebral autoregulation and lacol pulsewave velocity.
Amendment 2: Investigational Plan , revision D
Amendment 3: Investigational Plan, revision E
Amendment 4: Investigational Plan, revision F

The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with JNC-7 defined stage II hypertension that is resistant to treatment with at least three anti-hypertension agents, one of which is a…

Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care

The aim of this study is to explore the incidence of MTX related gastro-intestinal in a large cohort of JIA patients. Secondly, we want to investigate the effect of psychological behavioural therapy or switch to parenteral MTX dosing to ameliorate…

An open prospective randomized long-term effectiveness study, comparing best medical practice with or without adjunctive spinal cord stimulation in patients with chronic diabetic neuropathic pain

What is the long-term clinical benefit of best medical practice with and without adjunctive SCS Therapy in patients with chronic diabetic neuropathic pain?

Cervical spine movement, before and after anterior cervical discectomy (ACD).
ACD, pure intervertebral discectomy (1) compared to intervertebral discectomy followed by implantation of an intervertebral disc prosthesis (2) in patients with a radicular syndrome. A randomised study

Objective of the study is to verify whether the movement pattern after anterior cervical discectomy normalises, in case of implantation of a cervical disc prosthesis.

Evaluation of a newly developed spineboard in anaesthetized patients.

We want to study whether there is a difference with respect to the pressure exerted onto the body when using a normal spineboard and a newly developed spineboard, related to the level of consciousness of the volunteer. Also the experienced comfort…

Evaluating the effectiveness of an in-home self-management intervention to prevent psychological distress in frail older people living in the community

In the light of the aforementioned the current study has three objectives: 1) to study the effectiveness of an in-home self-management intervention to reduce fear of falling, avoidance behavior, catastrophizing about falls in order to prevent…

A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical PVD Induction for Treatment of Diabetic Macular Edema.

The purpose of this study is to evaluate if microplasmin is safe and effective when injected into the vitreous without performing a vitrectomy.

A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A

The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.

A randomised, double-blind, active-controlled, double-dummy, parallel group study to determine the safety and efficacy of oxycodone / naloxone prolonged release tablets in subjects with moderate to severe, chronic cancer pain

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to subjects receiving oxycodone prolonged release tablets (OXY) based on the Bowel Function…

Grip op je dip online (Master your mood online): development and effectiveness

The aim of the project is to further develop and study the effectiveness of the Internet groupcourse Gripop Je Dip Online for young people (16-25 years) with depressive symptoms.Development objective:The eight-session groupcourse will be adapted…

GRACE (Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe).Workpackage 10: Antibiotic Trial One

The aim is to understand which individuals benefit from antibiotics.

A Phase-II, double-blind, randomized, placebo-controlled study on the safety and early efficacy of Alkaline Phosphatase in sepsis patients with Renal Failure.

To establish the safety and and tolerability and early efficacy of Alkaline phosphatase in the treatment of sepsis patients with renal failure.

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease

The primary objectives of the study are to assess the safety and tolerability of E5555 in subjects with coronary artery disease (CAD) (Revised per Amendment 01).The secondary objectives are to determine the effect of E5555 on (a) the incidence of…

A MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED PHASE 3, EFFICACY AND SAFETY STUDY OF SUNITINIB (SU011248) IN PATIENTS WITH ADVANCED/METASTATIC NON SMALL CELL LUNG CANCER TREATED WITH ERLOTINIB

The purpose of this clinical trial is to test whether treatment of patients with NSCLC with erlotinib plus sunitinib is better than treatment with erlotinib plus placebo. All patients enrolling in this study will receive treatment with erlotinib.

A 12-month open-label, randomized, multicenter sequential cohort, dose finding study to evaluate the efficacy, safety and tolerability of oral AEB071 versus Neoral® in combination with Certican®, Simulect®, and corticosteroids in de novo adult renal transplant recipients

CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…

A psychological intervention in COPD patients who are hospitalized with an exacerbation: a RCT to improve health related quality of life outcomes and study mechanisms of change

To test the effects of a short psychological intwervention on quality of life, exercise capacity, self-management and health care utilisation.

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of Acute Coronary Syndrome (ACS). This will be assessed for a period of up to 16 weeks (…

A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety
and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill
Medical Subjects During and Following Hospitalization

To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…

Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.

Therapeutic exploratory study (Phase II).The purpose of this study the efficacy of a new compound (CPD323) for the treatment of Relapsing Remitting Multiple Sclerose (RRMS).CDP323 is a small chemical molecule. It is taken orally (by mouth) as a…

A randomised placebo-controlled trial of
fixed-dose combination medication in people
at raised risk of cardiovascular disease

To measure the efficacy (change in systolic blood pressure and LDL cholesterol) and tolerability of a polypill in individuals with raised risk of a cardiovascular event.