There are about 13332 clinical studies being (or have been) conducted in Netherlands. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Background The Trier Social Stress Test (TSST) is a valid and gold standard way for inducing psychosocial stress and is widely used in research and diagnostics. One of the downsides of the TSST is the difficulty to maintain the same experimental conditions repeatedly. A TSST in virtual reality (TSST-VR) is constant and requires far less time and personnel. Our TSST-VR version consist of three stress levels (no stress, moderate stress, high stress), a novelty in this field. Aim The aim is to investigate whether there is a statistically significantly greater increase directly after the TSST-VR in psychological and physiological stress parameters in the moderate and high stress levels compared to the no stress condition (control). Method A randomized controlled trial is conducted in healthy adults, with the three stress levels as conditions. Cortisol and questionnaires on anxiety and physical arousal are measured at baseline, during and after the TSST. Heart rate is measured continuously and adverse events are monitored.
The most common genetic risk factor for Parkinson's Disease is a heterozygous mutation of the GBA1 gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). Reduced GCase activity is associated with aggregation of the protein alpha synucleine (aSyn) in the central nervous system, which is related to the pathological cause of PD. Ambroxol is a mucolytic expectorant that appears to facilitate the refolding of the misfolded GBA protein thats acts as a chaperone for GCase. This randomized placebo-controlled trial aims to investigate the disease-modifying properties of ambroxol in PD patients with a GBA1-mutation. Patients will undergo motor and cognitive tests, as well as imaging and blood tests.
The study investigates the effectiveness of the mindfulness-based intervention "Mindful with your Baby" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and/or parental stress. The intervention "Mindful with your Baby" is one of the very few interventions for maternal postnatal mental health issues that takes the bond between mother and infant into account. It is hypothesized that the "Mindful with your Baby" intervention will reduce levels of postpartum depression, anxiety and parental stress, and improve mother-infant behavioral interaction and increase neural synchrony between mother and infant brains.
The goal of this randomized clinical trial is to test the effectiveness of the KOPPeling intervention that aims at unburdening COPMI (Children Of Parents with a Mental Illness). COPMI are at risk of overtaking the tasks of their parents when their parents are unable to fulfil such due to their psychiatric condition. By overtaking tasks and the urge to always take care of their parents, COPMI often do not participate in outdoor activities, which are necessary for their socio-emotional development. Moreover, insufficient socio-emotional development and parentification are risk factors for the development of psychiatric conditions. KOPPeling is an intervention for COPMI families that focuses on activating the social networks of the families. Within KOPPeling, a strategic plan will be developed and carried out with the goal of receiving support from the social network that will overtake tasks of the family to unburden COPMI. This study aims to answer the following questions: 1. To what extent does KOPPeling lead to an increase in Quality of Life (QoL) among COPMI? 2. To what extent does KOPPeling lead to an increase in mental health among COPMI? 3. To what extent does KOPPeling lead to a reduction of parenting stress among COPMI parents? 4. To what extent does KOPPeling lead to an increase in outdoor activities among COPMI? 5. How does KOPPeling affect the feelings of guilt of COPMI when engaging in outdoor activities? 6. What pre-conditions are needed to make KOPPeling widely applicable? 7. What are the long-term effects of KOPPeling on the QoL and psychological problems among COPMI and parental stress among COPMI parents? Participants will participate in the ten-to-twelve-week long KOPPeling intervention. Researchers will compare the intervention group with a waiting list control group to test the effect of KOPPeling on the QoL and mental health of COPMI and parental stress of parents.
The goals of this cross-sectional study are to compare immune cell composition and release of incretin hormones following a meal in healthy Dutch South Asians and Dutch Europids. The primary aim is to assess potential differences between Dutch South Asians and Dutch Europids with respect to immune cell composition and monocyte phenotype. The secondary aim is to assess potential differences between Dutch South Asians and Dutch Europids with respect to hunger and satiety hormones following a mixed meal test. The investigators will include healthy lean male and female participants of Dutch South Asian and Dutch Europid descent (n=48 in total).
In order to understand which ECAA patients benefit from medical therapy, more should be known about the possible outcomes of this rare disease. Small vessel disease seen on brain MRI's could be a good marker to assess possible silent cerebrovascular disease caused by ECAA's, suggesting underlying generalized vascular disease. With this knowledge, medical therapy for ECAA patients can be optimized and individualized to treat possible generalized vascular disease, aiding physicians in choosing a treatment strategy.
This study will investigate the safety and tolerability of multiple intravenous infusions of NX210c with two ascending doses as well as NX210c pharmacokinetics (PK), and pharmacodynamics (PD) effects, firstly in healthy elderly subjects, and the recommended dose to be used for Alzheimer's disease patients, in a second step.
Background: The majority of stroke survivors regain walking ability, however the ability to adapt their gait to meet environmental demands remains impaired. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting these gait deficiencies is, therefore, critical for allowing safe and independent community ambulation in people with stroke. Rehabilitation programs targeting gait adaptability have gained interest in clinical practice. Besides, the use of augmented and virtual reality in rehabilitation programs becomes more common. Concerning gait adaptability, training programs are developed using the Cmill, an instrumented treadmill with augmented reality. Even though the efficacy of these interventions is limited to small, pilot trials, results are promising. Based on these results we hypothesize that a gait training program using the Cmill will improve gait adaptability and daily-life gait performance in people in the chronic phase after stroke. Objective: The primary objective of this study is to evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke. A second objective is to identify patient characteristics that predict a more favorable response to training. Study design: Randomized, waiting-list controlled trial to evaluate gait adaptability training Study population: 84 stroke patients in the chronic phase after stroke
The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). It is expected that by using the CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).