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Relevance of Biomarkers and Clinical Predictors of Outcome in Unselected Population with Febrile Urinary Tract Infection at Primary Care and Emergency Department in a Prospective, Randomized Cohort Trial Comparing Short (7 days) Antibiotic Treatment with Conventional Treatment (14 days)

To assess clinical parameters and biomarkers in blood and urine in predicting bacteremia, need for hospital admission, clinical and bacteriologic cure and mortality in patients with fUTI.To determine whether a 7-day duration of antibiotic treatment…

Neural mechanisms of Oxytocin in human social-emotional behaviour in males and females

To gain insight in the neurobiological mechanisms behind oxytocin effects on human social-emotional behaviour.

Vitamin D in addition to RAAS blockade and dietary sodium for the Treatment of Urinary Excretion of albumin.

The primary objective of this study is to determine the antialbuminuric response of vitamin D analogue in addition to ACE-inhibitor and low-sodium diet, in renal patients.

A double-blind, randomized, mulicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

The purpose of this study in patients with primary progressive multiple sclerosis (PPMS) is to evaluatewhether FTY720 is effective in delaying MS disability progression in the absence of relapsescompared to placebo. Furthermore, safety and…

Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction: the EXAMI trial

The primary objective is to determine whether additional treatment with exenatide in patients with acute myocardial infarction and treated with primary PCI, leads to a more preserved left ventricular function, compared to placebo in addition to…

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks (Q3W) in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy.

The purpose of this study is to evaluate the safety of darbepoetin alfa, inclusive of the effects on survival and cancer progression, and the necessity of blood transfusions.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors Following Failure of at Least Imatinib and Sunitinib

The primary objective of this study is to compare the progression free survival (PFS) following administration of IPI-504 plus best supportive care versus placebo plus best supportive care in patients with metastatic and/or unresectable…

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures, Followed by an Open-Label Extension Study

Double-Blind Study CARISEPY3013:The primary objectives of this study are to compare the efficacy safety, and tolerability of carisbamate as adjunctive treatment of partial onset seizures, relative to placebo. The secondary objectives of this study…

A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.

The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with…

Effects of levosimendan on diaphragm contractility in healthy subjects

The primary objective of this proof of principle study is to determine the effect of levosimendan on the strength and endurance of the diaphragm in healthy subjects. The secondary objective is to gain insight in the neural activation and efficiency…

Does local application of betamethasonvalerate 0.1% cream twice a day reduce the complaints of chronic chilblains?

Research question:Does thin application of betamethasonvaleraat cream 0,1% on perniones lesions twice a day reduce the symptoms of patients as determined in 1st. line health care, with at least 10 mm expressed on a visual analogue scale, together…

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…

A first-in-human single-dose escalation study of the safety, pharmacokinetics and pharmacodynamics of the test drug including brain Serotonin Receptor Transporter (SERT) occupancy by Positron Emission Tomography (PET).

Part A: to investigate the safety and tolerability of the drug after a single oral dose in healthy male volunteersPart B: to explore the relationship between dose/exposure of the drug and brain serotonin receptor transporter (SERT) occupancy after a…

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE ESCALATION STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF SINGLE AND MULTIPLE DOSES OF 2-IMINOBIOTINE (2-IB) IN HEALTHY MALE SUBJECTS

Primary objectives- to investigate the safety and tolerability of single and multiple doses of 2-IB pulse iv infusion in healthy male subjects - to determine the pharmacokinetics after single and multiple doses of 2-IB pulse iv infusion in healthy…

A randomised, double-blind, placebo-controlled, single ascending dose, Phase I study to evaluate the safety, tolerability, and pharmacokinetics of PG110 (anti-NGF monoclonal antibody) in patients with pain attributed to osteoarthritis of the knee

The study has two objectives. Firstly, we will investigate the safety and tolerability of the study drug following administration of a single escalating dose of the drug. Secondly, we will investigate the rate at which the study drug is absorbed…

Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

BAY 63 2521 is a direct stimulator of the soluble Guanylate Cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially Pulmonary Hypertension (PH).To assess the efficacy and safety of oral BAY 63 2521 in the treatment of…

A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations

The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…

Maraviroc Immune Recovery Study (MIRS):
A multicentre, randomized, placebo-controlled, exploratory mechanistic study into the role of Maraviroc on immune recovery

The primary objective is to confirm the hypothesis that Maraviroc stimulates immune recovery; the ssecondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis.

A RANDOMISED, DOUBLE-BLIND, PARALLEL-GROUP STUDY EVALUATING THE EFFICACY AND SAFETY OF CO-ADMINISTRATION OF TRIPLE COMBINATIONS OF OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE, AND HYDROCHLOROTHIAZIDE COMPARED WITH THE CORRESPONDING OLMESARTAN-AMLODIPINE COMBINATION IN SUBJECTS WITH HYPERTENSION

Primary Objective1. The main objective of this study is to demonstrate that OM/AML/HCTZ triple combinations are more efficacious in lowering SeDBP than corresponding dual combinations of OM/AML after 10 weeks of double blind treatment.Secondary…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Postherpetic Neuralgia and Post-Traumatic Neuralgia, Followed by a Double Blind Safety Extension and an Open-Label Safety Extension

Primary Objectives• To evaluate the analgesic efficacy of JNJ-42160443 (1, 3, and 10 mg; administered as a single, subcutaneous injection every 28 days) in reducing average pain intensity, in subjects with postherpetic neuralgia neuralgia • To…