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Pharmacokinetic drug interaction study between rAltegraVIr and ATORvastatin (AVIATOR).

Primary objective:To assess the effect of multiple dose atorvastatin on the steady state pharmacokinetics of raltegravir and vice versa by intrasubject comparison in healthy subjects.• The comparison of steady state raltegravir (400 mg BID for 7…

SOM230 Graves Orbitopathy pilot trial

Therefore, we aim to investigate in a pilot trial the effect of SOM230 on predefined endpoints in patients with moderate to severe GO whom have contraindications for prednisolone therapy or decline from prednisolone therapy for other reasons.

prediction of everolimus-induced interstitial lung disease in breast cancer patients; maximizing efficacy by reducing toxicity

Primary objective:Analyze the value of pneumoproteins, everolimus exposure, pulmonary function tests, distinct radiological patterns, baseline patient characteristics and the development of skin toxicity or oral mucositis for the prediction of the…

An exploratory, blinded, randomized, placebo-controlled study in subjects with depressive disorder to investigate the effect of minocycline on relapse after successful intravenous ketamine/minocycline-induced (partial) symptoms response

Primary ObjectiveThe primary objective of this study is to assess whether the antidepressant response to IV ketamine can be maintained by minocycline compared to placebo.Secondary ObjectivesThe secondary objectives of this study are:* To investigate…

Optimizing the intermanual transfer effects after training with a prosthetic simulator

The objective of this study is to determine the optimal myo-electric prosthesis training for obtaining the largest transfer effect. Here fore we plan to execute three experiments. At first it needs to be revealed which trainingtasks leads to the…

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.

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…

Early Diagnosis Dyadic Intervention'(EDDI), an intervention for community-dwelling people with dementia and their caregivers: a pilot study

Objective of the project is to the American EDDI translate and adapt to the Dutch situation. Then, in a pilot study there will be examined whether the intervention is applicable to people with dementia and their caregiver, and if so, under what…

Facilitation of human long-term memory with post-learning physical exercise

To examine the behavioural and neural effects of a single session of post-learning exercise on long-term memory retention in humans.

Mesenchymal stromal cells for treatment of drug resistant pediatric Juvenile idiopathic arthritis

To find out if intravenous MSC is a safe treatment for children with therapy-resistant JIA

Phenotyping CYP2D6 in localized and in metastasized breast cancer patients using tamoxifen (metCYP study)

Primary-To compare CYP2D6 clinical phenotype by a 13C-DM-BT in LBC patients with MBC patients, and are currently using tamoxifen -To correlate CYP2D6 clinical phenotype by 13C-DM-BT to serum endoxifen levels in LBC and MBC patientsSecondary---To…

Using advanced MRI techniques to improve the planning treatment for head-neck hyperthermia and radiotherapy

The purpose of this study is to determine the thermal parameters by MRI scans at different time points during head-neck radiotherapy combined with hyperthermia treatment series.

CIP Pulsecath iVAC2L in High-Risk PCI patients

The primary objective is to evaluate the safety and efficacy of the PulseCath iVAC2L in highriskPCI patients who require left ventricular assistance. Safety will be assessed by theincidence of Cerebrovascular Accidents (CVA*s), thrombo-embolic…

Effects of methylphenidate on resting state connectivity in healthy controls and in adults with Attention Deficit Hyperactivity Disorder.

Primary Objective:The primary objective in the current trial is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. The main question we intend to answer in…

Conventional CABG and On Pump Beating Heart: a pilotstudy into the differences

These clinical pilot study examines whether there are differences between patients with ejection fraction (LVEF) > 30% who have undergone a CCABG or OPBH. We look at te myocardial damage, the use of inotropica, blood loss and blood…