Search for a trial

A randomized double-blind placebo-controlled phase 1 study regarding safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of ADRECIZUMAB (HAM 8101) in healthy male subjects.

To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.

APA12/PANTER* study: ""PTM202 and modulation of host resistance to diarrheagenic Escherichia coli in a randomized placebo-controlled trial in healthy human subjects"

To study whether PTM202, a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg, improves the resistance of humans to traveller*s diarrhea as caused by diarrheagenic E. coli. PTM202 contains specific…

Systemic antibiotic therapy (amoxicillin plus metronidazole) as an adjunct to surgical treatment of peri-implantitis; a single blind randomized controlled study

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plusmetronidazole therapy in conjunction with surgical treatment of peri-implantitis. The secondary objective is toassess the…

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative Pneumonia

To evaluate the efficacy (superiority) and safety of BAY 41-6551 as measured by the comparison of the clinical cure rate of aerosolized BAY 41-6551, administered via the PDDS Clinical, versus placebo (normal saline) at the Test-of-Cure (TOC0 visit…

The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia

Primary objective:­To determine whether endotoxin tolerance can be prevented by acetylsalicylic acid prophylaxis or can be reversed by acetylsalicylic acid treatment, expressed as an augmentation of pro-inflammatory cytokine levels during the second…

Clinical, microbiological, radiographical and heamatological evaluation of implant surface decontamination using air polishing in the non- surgical treatment of peri-implantitis; a randomized controlled study

The primary objective of this randomized controlled trial is to compare the clinical effect of decontamination of the implant surface during the non-surgical treatment of peri-implantitis using air polishing or ultrasonic treatment. Secondary…

Can Mild Induced Hypothermia reduce mortality in septic shock patients at the Intensive Care Unit?
A randomized, single-blinded, multicenter study. The cooling and surviving septic shock study

To investigate whether cooling to 33 °C for 24 hours in septic shock reduces mortality in intensive care patients.

The effect of Body temperature regulation on host response in patients with Septic shock
(A sub-study of the CASS study)

Primary: To determine the effects of MIH on circulatory, inflammatory and metabolic aspects of host response to sepsis.Secondary: To determine if MIH prevents and/or decreases the severity of ICU-AW in septic shock.

A Phase 1 randomized, double-blind study to investigate the single and multiple dose safety, tolerability and pharmacokinetics of WCK 4282 (FEP-TAZ) upon intravenous administrations in healthy volunteers

Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…

Stop Antibiotics on Procalcitonin guidance Study

The purpose of this trial is to evaluate whether procalcitonin measurements are able to reduce antibiotic usage in Dutch intensive care units by reducing the duration of antibiotic treatment.

The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

The effect of Staphefekt on the skin microbiome, including Staphylococcus aureus, in patients with atopic dermatitis.

To retrieve (in vivo) data about the effect of Staphefekt on the microbiome, including Staphylococcus aureus, and on disease severity in patients with atopic dermatitis.

Effect of donor human milk on severe infections and mortality in VLBW infants, a double blind randomized controlled trial

To determine whether (supplemental) human donor milk has beneficial effects (in terms of reduction of infectious episodes and mortality) when compared to (supplemental) preterm formula during the first 10 days of life in VLBW infants. Amendement ESS…

Clinical and microbiological evaluation of different implant surface decontaminating procedures in the surgical treatment of peri-implantitis; a randomized controlled study

The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surfaceduring the surgical treatment of peri-implantitis using a 35% phosphoric acid gel or saline.The secondary objective…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous WCK 4282 in Healthy Adult Human Subjects

To evaluate the safety and tolerability of multiple escalating doses of intravenous WCK 4282 in healthy, adult, human subjects.To evaluate the pharmacokinetics (PK) of multiple escalating doses of 1g:1g (1 vial) of intravenous (IV) WCK 4282 every 8…

Local gentamicin in Redon treated post-sternotomy mediastinitis

The aim of our study is to evaluate clinical outcomes of patients primarily closed over Redon catheters for the treatment of PSM, comparing the application of local gentamicin with a control group.

Hypertonic saline in primary ciliary dyskinesia: a pilot study

We hypothesize that hypertonic saline nebulizations improve respiratory symptoms and quality of life in PCD patients.

Phase 1, randomized, placebo controlled, double blind, single dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous IQNLF in healthy subjects.

To investigate the safety and tolerability of the intravenously applied (directly given into a blood vessel) new test compound.

Is antibiotic treatment associated with reduced risk of a subsequent exacerbation and mortality in chronic obstructive lung disease? A randomized clinical trial.

Study objective: To evaluate the long-term (cost-)effectiveness of antibiotic treatment added to corticosteroids in the treatment of exacerbations of COPD.

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…