There are about 13174 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.
Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training.
Hypertension affects 32-35% of the global adult population [1]. Despite many drugs being available [2] hypertension is not controlled in 50% of the over 500 million treated people [1], [3], leaving patients with an elevated blood pressure for life. In the development of isolated systolic hypertension, the aorta plays a pivotal role [4], [5]. With each heartbeat, the heart empties its stroke volume into the large arteries. These arteries, particularly the thoracic part of the aorta [6], temporarily distend to buffer the stroke volume and thereby dampen the pressure fluctuation: they have a Windkessel function [7]. When this function is reduced (and arterial stiffness is increased), the heart needs to contract more forcefully during ejection, leading to isolated systolic hypertension [5]. Likely, the aorta is not just a passive structure (the aorta as an elastic 'bicycle tube'). Rather, the smooth muscle cells in the aorta wall can presumably actively change the aorta's dimension through vasoconstriction/-dilation. If this is the case, such vasoconstriction/-dilation will have direct consequences for the aorta's Windkessel function and, since this Windkessel function directly influences the blood pressure flucturation, also for hypertension and its progression. Therefore, the aim of this study is to quantify the thoracic aorta's ability to vasoconstrict, and to assess whether this contractility is related to specific predictors. During the study we will measure in the operating room the thoracic descending and ascending aortic diameter with transoesopahgeal echocardiography (part of standard clinical care), before and after administration of vasoactive drugs (phenylephrine and norepinephrine; also part of standard clinical care). During these measurements we will simultanesouly measure peripheral arterial blood pressure and an electrocardiogram (ECG, to monitor sympathetic activity as estimated using heart rate variability analysis [8], [9]). Measurements will be performed at Catharina Hospital Eindhoven, the Netherlands (NL), where patients undergo elective cardiac surgery. Using the data obtained, we will 1) establish and quantify the in vivo contractility of the human thoracic aorta, and 2) study whether and to which extent potential predictors (age, sex, smoking status, antihypertensive medication use/class, mean arterial pressure, pulse pressure as an indirect measure of arterial stiffness, diabetes, chronic kidney disease, total cholesterol, and sympathetic activity) influence contractility
This study will assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.
Background: Practical and psychological barriers make it difficult for people with Suicidal Thoughts and Behaviors (STBs) to get professional help. Online interventions have the potential to overcome many of these barriers, but the online interventions to date have produced small or short-lived effects and have only been found to reduce suicidal thoughts, not behaviors. This is a crucial limitation, since previous studies have shown that interventions that reduce suicidal thoughts often do not prevent suicide attempts, and vice versa. Methods: A fully remote randomized controlled trial will be conducted in which 364 participants of 16 years and older will be recruited through the website of a suicide prevention helpline in the Netherlands and randomized with an allocation ratio of 1:1 to either Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT-SP) or a semi-guided online self-help course that has previously been found superior to waitlist in reducing suicidal thoughts. The primary outcome of the study is the number of suicide attempts, measured with the Columbia Suicide Severity Rating Scale. Secondary outcomes are self-reported suicidal ideation, healthcare utilization, treatment satisfaction, adverse effects, and quality of life. All outcomes will be assessed at baseline, immediately after the treatment and at 18 months follow-up. Discussion: If remote BCBT-SP proves effective, the findings of this study will add to the evidence base of BCBT-SP as one of very few psychological interventions with replicated effectiveness in preventing suicide attempts and provide the first evidence to date that remote interventions cannot only reduce suicidal thoughts, but also prevent suicidal behavior.
Rationale: Recent evidence shows that Lysergic Acid Diethylamide (LSD), even when administered in low, non-hallucinogenic doses, can produce analgesic effects and improve pain tolerance in a sample of healthy volunteers. Such results complement what was already observed with other serotonergic psychedelics such as psilocybin: survey studies and case series indicate that its use may lead to improvements in chronic pain conditions such as migraines, cluster headaches and phantom limb pain even at low, non-psychedelic doses. These effects have however not yet been investigated and confirmed in clinical populations under controlled experimental conditions. Fibromyalgia (FM) is a chronic condition characterised by widespread pain, hyperalgesia, anxiety, disturbed sleep patterns, impaired cognitive functioning and comorbid mood disorders. Most suggested therapies are only associated with small improvements in pain ratings and quality of life. Currently, there is no data concerning the effectiveness of serotonergic psychedelics in improving pain ratings in fibromyalgia patients. Objective: The present study will explore the effects that the administration of a placebo and 2 low psilocybin doses (5 mg or 10 mg) will have on pain perception in a group of fibromyalgia patients. Study design: The present study uses a double-blind, randomized, placebo-controlled design. All participants will receive a placebo and 2 doses of psilocybin (5 mg or 10 mg) and will undergo the Cold Pressor Test (CPT) and the Pain Pressure Threshold Task (PPT) o test its analgesic effects.
The goal of this randomized control trial is to test if contemplating in nature could benefit spiritual well-being in general adults. The main question it aims to answer is: Does a 2-week contemplative nature intervention improve spiritual well-being? Researchers will compare intervention conditions to active control (walking in nature) and passive control (waitlist) conditions to see if contemplating in nature works to improve spirituality. Participants in the intervention condition will walk for 10 minutes and then choose a nice spot to sit for 10 minutes. During these minutes they will be asked to be silently present and observe trees, plants, flowers, or other aspects of nature and contemplate their connectedness to nature and their own awareness. Then walk back 10 minutes. Participants in the active control condition will walk for 30 minutes without further instruction.
Suicide is the leading cause of death among young people (YP) aged 10 to 25 years in the Netherlands. In addition, YP report high rates of suicidal ideation (16%). While suicidal behavior is a complex phenomenon with many factors and causes, the role of social media is becoming more prominent, especially for YP. Social media has been shown to be a source where YP can find support, but it's also a place where suicidal behavior is glorified or normalized, which can be triggering or harmful to other social media consumers. The #Chatsafe guidelines were developed by Orygen Australia to better equip young people to communicate safely about suicide on social media. These guidelines are supported by a social media campaign to make the content of the guidelines more accessible to them. The #Chatsafe intervention consists of both the guidelines and the social media campaign. A small-scale Australian feasibility study showed promising results in terms of the acceptance and safety of the campaign, and safety regarding communicating about suicide on social media platforms. Currently, in Australia it is tested to what extent these results hold up in a Randomized Controlled Trial (RCT) (Robinson et al., 2023). With funding from the Dutch National Agenda for Suicide Prevention, a contextualized replication study is conducted. The aim of this study is to determine whether the #Chatsafe intervention has an effect on the way in which Dutch YP communicate online about suicide.
The objective of this study is to prospectively compare decongestive therapy administered by the Reprieve DMS system to Optimal Diuretic Therapy (ODT) in the treatment of patients diagnosed with acute decompensated heart failure (ADHF). The main objective is to determine if the Reprieve DMS is non-inferior to state-of-the-art urine sodium guided aggressive diuretic titration in two European HF centers of excellence.
The goal of this observational study is to explore difficulties in information access, mobility, communication and fatigue in people with combined vision and hearing impairments. The main question it aims to answer is: • What influence do varying severities of vision and hearing loss have on information access, mobility, communication and fatigue. Participants will fill out questionnaires and the researchers will measure their vision and hearing functions.
The goal of the study is to monitor and evaluate the implementation of interventions that aim to increase HPV & MMR vaccines among underserved communities across four European countries: Greece, Netherlands, Poland, and Slovakia. The interventions will target identified health systems barriers in an earlier phase of the project. The interventions that will be implemented employ trusted community members as health promotors whom will provide educational sessions on HPV and MMR vaccination to the target groups. In addition, the cost-effectiveness of vaccine uptake strategies for the target groups is being evaluated. The main research question is: to what extent is the multicomponent tailored intervention effective to increase MMR/HPV intention and vaccine uptake in the target population in Greece, Netherlands, Poland and Slovakia?