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BePATIENT-trial ;Assessing the value of eHealth for bariatric surgery

Assessing the value of online education with and without remote monitoring added to standard perioperative bariatric care

Closure after small skin incisions and excisions with a new closing system

compare the SoClose system with traditional skin wound closure with intracutaneous suturs of small skin excision on: cosmetics, wound healing, closing time, patient comfort and costs.

Examining the difference between healthy and pathological narcissism: the role of empathy

The present research proposal aims at investigating the distinction between healthy and pathological narcissism. In particular, the role of empathy is studied.The present study is the first in which patients with narcissistic personality disorder…

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of ALKS 7119 in Healthy Adults

Primary:* Evaluate the safety and tolerability of ALKS 7119 following oral administration of multiple ascending doses of ALKS 7119 in healthy male and female adultsSecondary:* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119…

The added effect of oral ondansetron to care-as-usual on persisting
vomiting in children aged 6 months to 6 years, presenting at primary care
out of hours service with acute gastro-enteritis and concomitant vomiting

The primary objective is to determine the added effect of oral ondansetron to care-as-usual (including ORT) (CAU) on persisting vomiting within the first 4 hours after presentation at an out-of-hours primary care service (OHS) in children aged 6…

Defining the optimal dose for continuous flucloxacillin infusion using pharmacokinetic modelling ;The FLUCON-study

Step 1 Primary objective: To describe the population pharmacokinetics of flucloxacillin for non-critically ill patients and determine the influence of covariates (demographics and renal function) on the kinetics of flucloxacillin. Step 2Primary…

Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour.

To evaluate the effects of long-term intranasal oxytocin on social behaviour in children with PWS and to compare the effects of different doses and frequencies of oxytocin administration

Spinal Morphine in Robotic Assisted Radical Prostatectomy

The primary goal is to increase the quality of recovery, as measured by the QoR-15-scale.Secundary goals are to decrease the use of systemic opiates, less bladderspasms and pain, reduce the side-effects op opiates, increase the patient-satisfaction…

National observational study to monitor the new guideline concerning treatment of atypical hemolytic uremic syndrome

Monitoring and evaluation of the Dutch guideline for treatment of aHUS in children and adults during two years.

89Zirconium-labeled nivolumab and 18F-labeled anti-PD-L1 as predictive imaging biomarkers of response and toxicity in nivolumab treated patients with non-small-cell lung cancer * a feasibility study

To assess uptake of 18F-PD-L1 and 89Zr- nivolumab in tumor lesions.

Tack Optimized Balloon Angioplasty Study for the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System. (TOBA II)

To compare the safety and efficacy of the Tack Endovascular System* in subjects with peripheral artery disease (PAD) to a pre-defined performance goal (PG).

Low volume high-intensity resistance training in type 2 diabetes: effects on glycemic control.

Primary Objective: (1) To study the efficacy of low volume high-intensity resistance training for improving glycemic control in patients with T2DM. Secondary Objectives: (2) To study the feasibility of low volume high-intensity resistance training…

Training alcohol-related attentional biases in alcohol-dependence. What are the neurocognitive effects?

The aim of the proposed study is to examine the effectiveness of this new form of attentional bias training as an add-on to treatment-as-usual in facilitating abstinence from alcohol use in patients diagnosed with alcohol dependence. Additionally,…

Evaluation of different wound dressings in the treatment of children with spoke injuries

To study wether a biodressing impregnated with polyhexamethylene biguanide in the treatment of spoke injuries in children could give a reduction in pain during the treatment compared to the standard treatment with wound dressing impregnated with

Minimally invasive versus open pancreatoduodenectomy

The objective of the LEOPARD-2 trial is to assess the safety of MIPD versus OPD and after that to assess the time to functional recovery of MIPD versus OPD for symptomatic benign, premalignant or malignant peri-ampullary disease.

Pharmacokinetics of new dexamphetamine sustained release tablets and the clinical validation of measuring dexamphetamine in dried blood spots

The main objective of this study is to determine the release profile of the dexamphetamine sustained release tablets in vivo in humans. Depending on the results, the tablets might be candidates for use in the therapy of attention deficit…

Hypofractionated Focal Lesion Ablative Microboost in prostatE cancer (Hypo-FLAME)

The main goal of this phase II study is to investigate whether a focal ablative SBRT boost to the macroscopic tumor is feasible and associated with acceptable toxicity in addition to whole gland prostate SBRT. Based on the present study, a phase III…

A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS

Safety (Primary) ObjectiveThe primary objective for this study is as follows:- To evaluate the safety and tolerability of cobimetinib in children and young adults, including estimation of the maximum-tolerated dose (MTD) or the maximum administered…

Implicit and explicit home-based training programs for young children with cerebral palsy: process evaluation and effectiveness on bimanual performance and parental stress

To assess fidelity (quality), dose delivered (completeness), dose received (exposure and satisfaction), recruitment and context of two newly developed upper limb home-based training programs, i.e. one based on implicit strategies and one based on…

Chloroprocaine vs prilocaine for spinal anaesthesia in day-case surgery: a double-blind randomized trial

To investigate effectiveness of spinal chloroprocaine, and prilocaine in day case surgery. The null hypothesis is that there is no significant intergroup difference in complete recovery from motor blockade.