All clinical trials

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.

The ALLEVIATE-HF study is a prospective, randomized, controlled, blinded, multi-site, interventional, investigational device exemption (IDE) pivotal study. The purpose of the study is to demonstrate the safety and efficacy of a patient management pathway that utilizes an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure, and to demonstrate the safety of the Reveal LINQ™ system and procedure in the study population.

Smokers with schizophrenia spectrum disorders have high rates of morbidity and mortality from smoking-related diseases compared with the general population and current options for smoking cessation in this vulnerable group are unsatisfactory. Considering that most people with schizophrenia spectrum disorders continue smoking, it is urgent to consider alternative and more efficient interventions to reduce or prevent their morbidity and mortality. Switching to combustion-free technologies for nicotine delivery (I.e. e-cigarettes) could be a pragmatic and much less harmful alternative to tobacco smoking with the possibility of significant health gains. Emerging research is suggesting that ECs may be useful for smoking cessation and relapse prevention in people with schizophrenia spectrum disorders. In particular, a study conducted with JUUL e-cigarette with 5% nicotine strength showed that this product had sufficient nicotine delivery and product appeal to determine high success rates in heavy smokers with schizophrenia spectrum disorders. In consideration of these preliminary findings, we hypothesized that switching smokers with a schizophrenia spectrum disorder diagnosis to JUUL e-cigarette with 5% nicotine strength could result in higher success rates compared to JUUL e-cigarette with 1.7% nicotine strength. Recent work indicates that nicotine PK of the JUUL e-cigarette with 5% nicotine strength (a device that utilizes a nicotine salt formulation) approximates the nicotine delivery of combustible cigarettes and that the 5% nicotine strength product is far more efficient in delivering nicotine compared to the sister product with 1.7% nicotine strength. Both products are identical in their appearance, making them suitable for a double-blind study design.

Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One recommended intervention is cognitive stimulation. We try to develop serious games as a further treatment option, also usable in pre-dementia as well as early stages of dementia and for a long period of time. The main objective of this study is to test, if the computerized-cognitive training (CCT) is able to improve the performance in a score quantifying an "AD-specific" component score. Additionally, the neurobiological effects of the training are investigated.

Endometriosis affects 10% of reproductive aged women and causes severe pain and impaired quality of life (QoL). Surgery for endometriosis results in long term symptom relief in only 40% of women. QoL in endometriosis improves after surgery, but not to the level of healthy women. Mediators in QoL include pain intensity, pain cognitions, and stress. In a preliminary study, patients with negative pain cognitions reported higher pain intensities compared to patients with positive pain cognitions. This indicates that psychological factors explain considerable variance in pain, suggesting that changing these factors by psychological interventions may contribute to improving QoL. Cognitive behavioral therapy (CBT) is proven effective as a psychological treatment for pain-related symptoms. The primary objective of this study is to investigate whether usual care combined with CBT improves QoL in patients undergoing surgery for endometriosis compared to usual care only. Secondary objectives are to investigate whether pain intensity, pain cognitions, perceived stress, fatigue and objectively measured cortisol levels mediate the effects of CBT on QoL in both groups. In a randomized controlled trial, 100 endometriosis patients undergoing surgery will be randomized between usual care with CBT (CBT group) and usual care only (control group). Women in the CBT group will receive, in addition to usual care, one pre-surgery and six post-surgery sessions of CBT, aimed at positively influencing mediators of QoL. Women in the control group will receive only usual care. Follow-up will be 7,5 months. In both groups QoL, pain intensity, pain cognitions, fatigue, perceived stress (using questionnaires) and objective stress (assessing cortisol in a hair sample) will be assessed at baseline assessment, T1 (two weeks after completion of all CBT sessions) and T2 (follow-up). Recruitment and treatment of patients will take place in Rijnstate hospital and Radboud University Medical Center (UMC).

The rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.

Stroke affects 16.9 million individuals each year and is the second leading cause of death worldwide. Despite advances in pharmacologic therapy, morbidity , mortality and rates of hospitalization for stroke remain high. These data emphasize the importance of identifying all treatable conditions that could aggravate stroke. One such condition is obstructive sleep apnea (OSA). Sleep-related breathing disorders, including obstructive and central sleep apnea, often coexist with stroke. Compared to the general population, in whom OSA is the most common form of this breathing disorder with recent prevalence estimates of 22% of male and 17% of female , in the stroke population, the prevalence of OSA is much greater at 70% . Several randomized controlledtrials on OSA patients with stroke in acute or sub-acute stage showed that treating OSA with continuous positive airway pressure (CPAP) improved motor and functional outcomes, accelerated neurological recovery.Apart from the benefits in better neurological outcomes, secondary analyses of SAVE study suggested that CPAP treatment potentially help to reduce recurrence of stroke. Nevertheless, we don't have evidence yet from randomized control studies to prove CPAP treatment would reduce the recurrence of cardiovascular or cerebrovascular events. Traditionally, recurrence of cardiovascular or cerebrovascular events uses documented mortality, morbidity or hospitalization for heart failure, acute coronary syndrome or stroke as clinical endpoints. Recently, several studies showed that enlarged left atrium (LA) can serve as a predictor for recurrent stroke or cardiovascular events. On the other hand, a growing body of studies demonstrated that CPAP treatment reduce size of LA in those with OSA. Notably, all of these studies above are observational or retrospective in nature. To date, there are no prospective longitudinal randomized controlled trials reporting the effect of CPAP treatment of OSA on the change of size of LA. We therefore will undertake a randomized , controlled trial involving patients with stroke to test the primary hypothesis that treatment of OSA with CPAP would reduce the size of LA.

The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.

The purpose of this study is to determine the safety and efficacy of the combination therapy of TTFields + SRS+ Temozolomide (TMZ) for newly diagnosed glioblastoma (GBM).

In this study, the main goal is to implement and evaluate a novel, evidence-based psycho-educative program for children in oncological care. Patients are provided with booklets tailored to each specific stage of their treatment. Among other factors, children's emotional well-being is evaluated as well as feasibility. The study is carried out at multiple sites across Austria, Germany and Italy/South Tirol.