Search for a trial

Non-invasive MRI spectroscopy at 7 Tesla in lymphoma

The primary objective of this project is to investigate whether 7T MRI spectroscopy biomarkers lactate and phospholipids can differentiate between aggressive and indolent lymphoma non-invasively. The secondary objective of this study is to assess…

Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)

Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…

Use of individual PK-guided pazopanib dosing: A feasibility study in patients with advanced solid tumors

primary• To determine the safety and feasibility of PK guided dosing of pazopanib secondary• Evaluation of the dried blood spot procedure• To determine the objective response rate (according RECIST 1.1)• To determine the time to tumor progression…

A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels

The primary objectives of the study are the following:* To assess the dose response of the following parameters:* Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to Week 12* Percent change in TG from baseline to…

Hydros and Hydros-TA Joint Therapy for Pain Associated with Knee OA;
A Multi-center, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Hydros and Hydros-TA Joint Therapies for Management of Pain Associated with Osteoarthritis in the Knee

The purpose of this study is to evaluate the safety and efficacy of Hydros-TA Joint Therapy for relief of pain due to OA of the knee. Hydros-TA is designed to provide fast acting and long lasting pain relief for up to six months with a single IA…

IMT measurements during the follow-up of children after Kawasaki disease: the necessity for a control group.

To investigate whether children with a history of Kawasaki disease have an increased IMT and arterial stifness compared to their healthy siblings.

A Phase I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: octocog alfa) in Subjects with Hemophilia A, and a Repeat PK, Safety and Efficacy Study

The study objectives are to determine the incidence rate of FVIII inhibitors, frequency of adverse events (AEs), and serious adverse events (SAEs) associated with the use of CSL627, to evaluate the PK of 50 IU/kg CSL627, and to evaluate the efficacy…

Randomized, first in human, double-blind, placebo- and active comparator- controlled 3-way crossover study in healthy male subjects (part 1), and a subsequent parallel open label study in healthy male and female subjects and MS patients (part 2), to assess the safety, pharmacokinetics and pharmacodynamics of 2B3-201.

Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…

A randomized, double-blind, placebo-controlled clinical trial assessing the efficacy of combining pasireotide with aspiration sclerotherapy to improve volume reduction of dominant hepatic cysts

The primary objective is to minimize fluid reaccumulation in the hepatic cyst after aspiration sclerotherapy in order to reduce cyst size. The secondary objectives are to reduce symptoms, improve health-related quality of life (HRQL), and reduce…

The modified Atkins diet in patients with refractory epilepsy and severe intellectual disability: a randomized controlled trial.

The main objective is to evaluate the effect of the modified Atkins diet on the seizure frequency of institutionalized adults with refractory epilepsy and severe intellectual disability.

HYPerbaric OXygen therapy for benign anastomotIC esophageal strictures: a pilot study

The overall objective of this pilot study is to evaluate the effect of HBOT on recurrent and refractory esophageal anastomotic strictures.

An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant, Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B.

Primary: The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.Secondary: The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of…

Axetis Inert Coronary Stent System First in Man (FIM) Clinical Investigation

The objective is to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.

A double blind, randomized, placebo controlled, cross-over study to validate the predictive power of the demarcation formula for Lybrido and Lybridos efficacy in women with female sexual interest/arousal disorder, in the domestic situation.

Primary Objective• To validate the existing demarcation formula (consisting of psychometric and biological markers) which predicts the sensitivity to Lybrido or Lybridos in women with female sexual interest/arousal disorder (FSIAD with or without…

A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered,
Single and Multiple Ascending Dose, Multicenter Study Evaluating the
Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects
with Moderate to Severe Ulcerative Colitis

The primary objectives of this study are as follows:* To assess the safety and tolerability of escalating single and multiple doses of GS-5745 in subjects with moderate to severe ulcerativecolitis (UC) as assessed by adverse events (AEs), and…

Advanced PET and MRI techniques for improved therapy response assessment in diffuse large B-cell lymphoma / follicular lymphoma grade 3B

This project will first address the hypothesis that dual time-point 18F-FDG PET and DWI improve the discrimination between residual active tumor and inflammatory/necrotic changes after two cycles of R-CHOP in DLBCL / follicular lymphoma grade 3B ,…

Clinical evaluation of blood glucose variability with continuous intravenous measurement in ICU patients (GLIC-study)

Our hypothesis is that continuous intravenous glucose monitoring is helpful in ICU patients treated with IIT to:a) reach and maintain the glucose-target of 4.4-6.1 mmol/L soonerb) to increase safety, by eliminating the development of hypoglycaemiac…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects with Uncomplicated Influenza.

Primary ObjectiveTo evaluate the clinical efficacy of favipiravir compared with placebo in treating adult subjects who have confirmed influenza.Secondary Objectives- To further evaluate the clinical and anti-viral effects of favipiravir.- To…

The effects of 'HealthBread4Kids' vs. brown bread in overweight adults

To this end, two study protocols have been developed, one concerning the *target group* of overweight children (aged 12-16), only including non-invasive measurements, and one targeting adult overweight participants (aged 18-45), allowing for…

Efficacy of Statin Therapy on Atherosclerotic Inflammation in Patients with Ankylosing Spondylitis

To evaluate anti-inflammatory effects of statin therapy on vessel wall inflammation by means of FDG PET/CT in AS patients.