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A randomised, double-blind, parallel group PhIII study to assess the clinical efficacy and safety of 100 mg SC Mepolizumab as an add on to maintenance treatment in adults with severe bilateral nasal polyps (study 205687, SYNAPSE)

Primary:To evaluate the efficacy of 100mg mepolizumab compared to placebo.Secondary:The impact on actual nasal surgery. Further efficacy assessment. Quality of life.

A placebo-controlled double blind randomized trial to investigate the efficacy and safety of the combination of Penicillin G / Hydrocortisone treatment in ALS patients (PHALS).

The objective is to compare the efficacy and safety of intravenous high-dose penicillin G and hydrocortisone versus placebo in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

A Phase 2, Single dose, Open-Label, Exploratory Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

4.1 Primary• To estimate the Sensitivity and False Positive rate of OTL38 for malignancy detection during Near Infrared Imaging (NIR).• To assess the safety and tolerability of single intravenous doses of OTL384.2 Secondary• To assess the safety of…

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of LTI-291 in Healthy Middle-Aged to Elderly Subjects

- To evaluate the safety and tolerability of four oral dose levels of LTI-291 following multiple administrations in healthy middle-aged to elderly subjects. - To characterize the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK) of LTI-291…

Randomized, double-blind, double-dummy, placebo-controlled, four-way crossover single dose
study to determine the test-retest reliability of, and the effect of oral valproic acid, levetiracetam and
lorazepam on, cortical excitability measurements in healthy volunteers as measured by TMS-EEG and TMS-EMG.

Primary Objective- To investigate the ability of TMS-EEG measures to detect effects on cortical excitability of valproic acid, levetiracetam and lorazepam in healthy subjects- To investigate the ability of TMS-EMG measures to detect effects on…

A phase 2, double-blind, randomized, placebo-controlled pharmacokinetic trial in two parallel groups to investigate possible drug- drug interactions between stiripentol or valproate and GWP42003-P in patients with epilepsy.

Primary Objective: To determine whether GWP42003-P affects the pharmacokinetic (PK) profile of stiripentol (STP) or valproate (VPA).Secondary Objective: To assess the safety and tolerability of GWP42003-P in the presence of STP or VPA.To assess…

The MPAC-study: validating craniocaudal tumor extension on MRI with histoPAthology in patients with Cervical cancer

To validate MRI for assessing craniocaudal tumor extension with histopathology using non-rigid egistration. In addition to 3 Tesla magnetic resonance T2-weighted imaging, diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE) imaging…

Radiotherapy of the head without the need of a thermoplastic mask, a clinical feasibility study.

To prove the clinical feasibility of palliative whole brain radiotherapy without using a thermoplastic mask. Clinical feasibility in this study is defined when more than 70% of the patients can complete the radiation treatment without a mask. We…

Clinical pharmacokinetics of intravenous docetaxel in patients with castration-resistant
prostate cancer and non-castration-resistant prostate cancer

To determine the exposure and clearance of intravenous docetaxel in patients with castration-resistant prostate cancer and non-castration-resistant prostate cancer. All samples will be measured with a validated LC-MS/MS method

Open label, randomized, cross-over study to explore the pharmacokinetics of BAY 1834845 after oral and intravenous dosing, including food effect and absolute bioavailability (Part A), and to investigate the effect of BAY 1834845 on the pharmacokinetics of orally administered methotrexate (Part B) in healthy male subjects

The purpose of the study is to investigate how quickly and to what extent BAY 1834845 is absorbed and eliminated from the body (this is called pharmacokinetics). In both study parts it will also be investigated to what extent BAY 1834845 is…

Oro-sensory exposure, eating rate and satiation

The primary objective of this study is to determine the independent and additive effects of oro-sensory exposure (mastication effort) and ingestion rate (bite interval) on satiation in relation to the cephalic endocrine and metabolic hormonal…

Lexical Production and Cognitive Control in Bilinguals

Thus far, what previous literature has dealt with, addresses the neural mechanisms involved in L1 and L2 lexical production separately (e.g. Hernandez & Meschyan, 2006; Liua et al., 2010; Reverberi et al., 2015), irrespective of any…

Costs of Implant-supported Over-Dentures (IOD) can be halved using a digital workflow

Our goal is to manufacture a 3D-IOD which is designed digitally, and subsequently 3D-printed. Such 3D-IOD, can be made cheaper, faster and more patient friendly. To prove such a statement, patients should at least be even satisfied about their 3D-…

Compromised mandibular function in Juvenile Idiopathic Arthritis: intervention

To contrast jaw exercises and corticosteroid injection via arthrocentesis in children with JIA and MRI confirmed TMJ arthritis despite 1 year regular treatment by the rheumatologist, in a randomized clinical trial, both in combination with continued…

Language representation in children with 22q11 deletion syndrome and children with Specific Language Impairment

The main objective of this study is to determine the language representation in the brain of children with SLI and 22q11DS.

An exploratory, multicenter, placebo-controlled, randomized, double-blind study to investigate the antidepressant mechanism-of-action of JNJ-42847922 in subjects with major depressive disorder.

To investigate the effect of JNJ-42847922 given as monotherapy as compared to placebo on symptoms of depression in male and female MDD patients

A First-in-Human Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of LTI-291 in Healthy Subjects

- To evaluate the safety and tolerability of four different single oral doses of LTI-291 in healthy subjects.- To characterize the plasma pharmacokinetics (PK) of LTI-291 following single oral dosing in healthy subjects.- To evaluate the…

Cognitive behavioral therapy for Misophonia, RCT

To evaluate the effect of the CBT groep treatment for misophonia.

An exploration of intestinal bacterial biofilms in Lynch syndrome patients as disease markers for colorectal cancer

Lynch-related tumors mostly develop in the ascending right side of the colon (70-85%). Strikingly, it was recently discovered that dense bacterial biofilms and invasive bacteria occur in the colonic mucosa of 87% of right-sided colorectal cancer (…

A single arm multicenter biomarker study determining the response to taxane-based chemotherapy in metastatic breast cancer (MBC) patients with ESR1 mutations in cell-free DNA: TAX-ESR1 study.

The primary objective of this study is to assess the outcome of taxane- based chemotherapy in ER-positive MBC HER2-negative patients with progression after receiving endocrine therapy (with at least an AI) who have an ESR1 mutation measured in…