Search for a trial

A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

In subjects with T2DM, with inadequate glycemic control, who have a history or high risk of CV disease:Primary Objectives*to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on CV risk as measured by…

Prevention of the progression of very early symptoms into ankylosing spondylitis

The general aim of this project is the primary prevention of the development of AS in patients with IBP, additional (SpA) features and inflammation on MRI of the SI joint and/or spine (but still no sacroiliitis on X-ray) by giving them, a short…

The effects of plant sterol and stanol esters on serum oxyphytosterol concentrations in healthy human subjects

The major objective of the present study is to examine the effects of dietary plant sterols and stanols on fasting serum concentrations of oxyphytosterols. The minor objective is to investigate the effects of these products on postprandial serum…

A Phase 1, randomized, double-blind, controlled trial to evaluate the safety and immunogenicity of increasing intranasal doses or of three intramuscular doses of the adjuvant Gram-positive Enhancer Matrix (GEM) administered with a standard dose of trivalent inactivated influenza vaccine (TIV) antigens, compared to a standard dose of TIV antigens administered either intranasally or intramuscularly in healthy adult volunteers; followed by a randomized, double-blind, controlled evaluation of safety

To assess the safety, reactogenicity, and tolerability of increasing GEM intranasal doses (1.25 mg, 2.5 mg and 5.0 mg) and intramuscular doses (0.05, 0.1, 0.2 mg) of the GEM adjuvant, each administration containing as well a standard 2010/2011 Flu…

Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)

To determine whether aleglitazar reduces cardiovasculair mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and type 2 diabetes.

Reduction of asthma exacerbation rate in children by non-invasive monitoring of inflammatory markers in exhaled breath (condensate): the RASTER study

The purpose of the present proposal is to improve care to children with asthma by including regular assessments of non-invasive inflammatory markers during the management of asthma. In this case, treatment is also guided by inflammatory markers (…

Immunization with different numbers of Plasmodium falciparum infected mosquito-bites under chloroquine prophylaxis

Primary Objective: To determine if two thirds or one third of the CPS immunization dose still induces complete protection against an experimental malaria challenge. Secondary Objectives: • To study and compare parasitemia and kinetics of parasitemia…

Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD, a randomized double-blind placebo-controlled trial

To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the previous year can decrease the exacerbation rate in the year of treatment.

The effects of oral dipyridamole treatment on the innate immune response during human endotoxemia.

Primary objective: The primary objective of the study is to determine the effect of oral dipyridamole treatment on the innate immune response induced by a lipopolysaccharide (LPS) challenge. Various pro- and anti-inflammatory cytokines will be…

A Randomized, Double - Masked, Placebo - Controlled Study of PRM - 151 in the Prevention of Postoperative Scarring in Glaucoma Patients Following Primary Trabeculectomy.

Primary: To assess the effects of PRM-151 compared to placebo on the success of trabeculectomy by reducing post-surgical scarring in glaucoma patients who have undergone primary trabeculectomy, evaluated at day 120.Secondary: To assess the safety…

The (cost) effectiveness of an intervention on energy balance related behaviours and work engagement

The study aims to develop an intervention to improve workers' energy balance related lifestyle behaviours (EBRB) to prevent overweight and to improve work engagement and subsequently evaluate the intervention developed.

Comparison of three Plasmodium falciparum isolates in an experimental human malaria infection

• Primary objective (parasitological): To investigate the kinetics of parasitemia of different Plasmodium falciparum isolates• Secondary objective (immunological): To investigate parasite development and immunological properties of different…

A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light eruption (PLE).

Primary Objective - To determine if afamelanotide can reduce the severity of PLE related pruritis.Secondary Objectives- To determine if afamelanotide can reduce the frequency of PLE episodes;- To determine if afamelanotide can reduce the duration of…

Sitagliptin prophylaxis for glucocorticoid-induced impairment of glucose metabolism and beta-cell function in males with the metabolic syndrome-X: a randomized, placebo controlled, double blind, 2x2 factorial designed intervention trial.

The objective of this study is to assess whether sitagliptin may prevent prednisolone-induced impairment of glucose metabolism and beta-cell function.

Dipeptide Alanyl Glutamine and Postoperative Insulin Resistance in Colon Carcinoma Patients

The effect of the dipeptide alanyl-glutamine, intravenously or enterally and perioperatively given, on postoperative insulin resistance in colon cancer patients.

A Prospective, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter, Event-Driven, Non-inferiority Study Comparing the Efficacy and Safety of Once Daily Oral Rivaroxaban (BAY 59-7939) With Adjusted-Dose Oral Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation (39039039AFL3001)

The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…

A multi-centre randomised double blind, placebo and active controlled parallel group study to investigate efficacy and safety of ONO-5334 in post menopausal women with osteopenia or osteoporosis.

The objective of this study is to investigate if use of ONO-5334 has a more positive effect on bone density and biochemical markers of bone turnover than Alendronate (a bisphosphonate) and placebo.

A Phase III, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study to Confirm the Safety and Efficacy of Subcutaneous Bioresorbable Afamelanotide Implants in Patients with Erythropoietic Protoporphyria (EPP).

Primary objective: - To determine whether afamelanotide can reduce the severity of phototoxic reactions in patients with EPPSecondary objectives:- To determine whether afamelanotide can reduce the number of phototoxic reactions in patients with EPP…

Prevention of delirium in acute stroke

To evaluate whether preventive treament with haloperidol lowers the risk for delirium in stroke patients with an increased risk for delirium.

The influence of supplementary regional infiltration anesthesia with ropivacaine on postoperative pain, nausea and vomiting in patients undergoing mamma surgery under general anesthesia

To investigate that in mamma surgery, regional infiltration with ropivacaine 0,75% added to general anaesthesia causes less postoperative pain, nausea and vomiting compared to general anaesthesia alone.