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Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…

Assessment of real life and trained inhalation of Tobramycin Inhalation Powder (TIP) and Tobramycin Inhalation Solution (TIS) TIPTIS study.

Primary objective of the study is to record TIP inhalations on video at home to study the association between inhalation manoeuver and cough. Secondary objectives are: To study the inhalation maneuvers of patients using TIP in the home situation; to…

Mindfulness and attention

The objective of the current study is to investigate the effect of mindfulness training on attention shifting in a pain setting. This question will be tested in an experimental design. Outcomes of the study will be used to further investigate…

Effects of Trauma Focused Cognitive Behavioural Therapy (TF-CBT) and Eye Movement Desensitization and Reprocessing (EMDR) for children with Posttraumatic Stress Symptoms

The main objectives of the present study are: determining short and long term effects of TF-CBT and EMDR; assessing the efficiency of these therapies; and identifying the characteristics of those children who do not respond to the given treatment.

Inamed 410 Silicon-Filled Breast Implant European MRI-Study

proof of safety of the Style 410 silicon breast implants

A study of the effects of a novel ovarian stimulation regimen on embryo aneuploidy rates in IVF, and the impact of aneuploidy on implantation, as assessed in an in vitro model.

In this study we aim to compare the effect of two different ovarian stimulation protocols on embryo quality in a group of women of 39 years or younger, in a prospectively randomized controlled trial. PGS will be performed to assess chromosomal…

An Open-Label, Phase I Study to Evaluate the Pharmacokinetics and Tolerance of Co-administration of Oral Multiple Dose of Ketoconazole and an IV (bolus) Infusion of Eribulin in Patients with Advanced Solid Tumors

Primary objective: To study the influence of repeated oral administration of ketoconazole, a potent CYP3A4 inhibitor, in a therapeutic dose on the plasma pharmacokinetics (PK) of eribulin administered via intravenous (IV) infusion.Secondary…

Training of the myoelectric signal by training opening and closing of the prosthetic hand

To investigate whether different ways of training hand opening and closing of a myoelectric device will lead to comparable results.

The TOUCAN trial: a randomised, blind, clinical trial that compares the effects of TOUpet fundopliCAtion and Nissen fundoplication on the mechanics of the gastroesophageal junction.

To identify differences in the mechanisms leading to dysphagia after laparoscopic Toupet and Nissen fundoplication.

Developmental Evaluation of Children: Impact and Benefits of Early hearing screening strategies Leiden

What is the effect of the distraction hearing screening strategy compared to the neonatal hearing screening strategy on speech and language development and other developmental parameters in children with permanent childhood hearing impairment (PCHI…

Chlamydia Screening Implementation Project

The aim of this pilot implementation is first to make a serious start in Chlamydia screening and secondly to determine feasibility, affectivity and cost-effectivity. The results of this pilot implementation will be leading for the decision about the…

MRI-guided transcranial magnetic stimulation on artificial centre embedding grammars

The two main objectives of this experiment is firstly to replicate the finding that repetitive transcranial magnetic stimulation (rTMS) of the inferior frontal cortex (IFC) can interfere with artificial syntactic classification and secondly to…

Short-term individual experiential schema therapy in adult outpatients with cluster C personality disorders: (How) does it work?

Primary Objective: To determine whether short-term experiential ST improves overall wellbeing in adult out-patients with cluster C PD, directly after treatment, at 3 months treatment follow-up (treatment-FU), and at 6 month measurement-FU. 6 months…

*Trauma-informed approach for unaccompanied refugee minors: a multiple baseline case series*

The primary objective of this study is to measure the effectiveness of the TFT for URMs living in the Netherlands. The research question is as follows: is this TFT effective in decreasing symptoms of posttraumatic stress and depression in URMs…

The effectiveness of EMDR in young children (1,5 to 8 years) with PTSD

It is investigated whether EMDR is effective in reducing post-traumatic stress reactions in young children (1.5 to 8 years), reducing co-morbid emotional and behavioral problems and whether the results will be maintained 3 months after treatment. In…

The effect of Eye Movement Desensitization and Reprocessing (EMDR) on Illness Anxiety Disorder (IAD): two multiple baseline n-of-1 trials across seven participants each.

Primary Objective study 1: The primary objective of study 1 is to explore the effectiveness of EMDR treatment targeting images of historic traumatic events in reducing the daily rated illness anxiety symptoms of patients with IAD.Primary Objective…