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.
Rationale: Primary antibody deficiencies (PAD) encompass a group of rare heterogeneous diseases. The clinical presentation may vary widely, including infectious and autoimmune symptoms and increased risk of malignancy. Due to the rarity of the diseases and this wide array of symptoms there is often a delay in diagnosis, of up to 12 years on average1-4. Timely diagnosis of PAD reduces morbidity, mortality and health care costs as effective therapies are available. The currently available screening systems for the broader group of primary immunodeficiencies (PID) have been shown to have poor diagnostic performance5-10 and are time consuming. We have thus developed an algorithm to screen patient records in a primary care setting for risk factors specifically for PAD. Patients with a high risk may undergo a laboratory assessment and referral if necessary, thus reducing the diagnostic delay of PAD. The aim of the current study is to validate this algorithm. Objective: Main objective: to validate a screening algorithm for PAD in a primary care setting in the Netherlands. Study design: Mono-centre cohort study based on regular care data Study population: Primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
Preoperative multidisciplinary team (MDT)discussions are recommended by national and international guidelines. However, no guidance is given on how to organise and execute an MDT discussion. The objective of this study is to describe the methods used for preoperative MDT discussion executed in the Netherlands.
Mycosis fungoides (MF) is an ultra-orphan disease of which the etiology remains unknown. MF is diagnosed by correlating clinical appearance with histopathological analysis of often multiple invasive skin punch biopsies. To move patient care and the development of novel treatments for MF forward, objective, sensitive and reliable tools that are preferably non-invasive are desired. Therefore, the objective of the current study is to phenotype the early stages of mycosis fungoides in detail and to assess the response of chlormethine (CL) gel monotherapy. With this approach the investigators aim to detect novel biomarkers and to establish methodologies for the (non-)invasive monitoring of MF.
This study will investigate the effectiveness of an engagement-based personalized 2-week mobile wellbeing intervention, vs the effectiveness of a non-personalized 2-week mobile wellbeing intervention.
This is an interventional, open-label study to evaluate the safety, tolerability and PK of escalating single doses of G3P-01 in 10 healthy adult subjects. All participants will receive G3P-01 in sequential, escalating doses of 50mg (Period 1), 500mg (Period 2), 1,000mg (Period 3), and 2,000mg (Period 4). A wash out period of at least 7 days will occur between doses in each sequential treatment period. Subjects will be admitted Day 1 and stay overnight until the morning of Day 2 for each treatment period. There will be a follow up call 14 days (+/- 2 days) following the last dose of the IP.
Clofazimine (CFZ) is a promising drug for the treatment of NTM diseases. CFZ is highly active in vitro against M. abscessus and M. avium, the most common NTM pathogens, and shows synergy with macrolides and amikacin. The results from limited clinical studies with CFZ-based treatment regimens are promising. CFZ is currently considered an alternative drug for patients with M. avium complex infections, who are intolerant of first-line drugs. CFZ is a first-line oral drug for treatment of M. abscessus infections. CFZ might prove to be a cornerstone in NTM treatment, but its optimal dosage is not known. The current dose for adults is 100 mg oncedaily. However, due to the complex pharmacokinetics (PK) of CFZ - it is highly protein bound, extremely lipophilic and accumulates in fatty tissues resulting in a long elimination half-life of ~30 days - it takes several months before steady state, and presumably effective, concentrations are achieved. With the use of a loading dose regimen concentrations similar to those at steady state could be reached faster, possibly leading to improved early treatment efficacy. The overarching aim of this study is to contribute to dose optimization of CFZ in the treatment of NTM diseases. It will be an explorative, single-center, one-arm, open label, pharmacokinetic study. A number of 10 patients with pulmonary or extrapulmonary NTM disease will be included. Patients will receive a loading dose regimen of 300 mg once daily for 4 weeks and will then continue with a standard dose of 100 mg once daily until a total 4 months of treatment with CFZ. The primary objective of this study is to describe the PK of CFZ, after 4 weeks of treatment with a loading dose regimen of 300 mg once daily, in adult patients with pulmonary or extrapulmonary NTM disease
In August 2020, West Nile Virus (WNV) was isolated from a live common whitethroat for the first time in The Netherlands. Follow-up sampling showed that the virus could also be detected in mosquitos from the same location during at least a whole month of sampling. On 15 October 2020, one case of West Nile virus infection has been reported in a man who was likely infected in the Utrecht region. This is the first time that a locally acquired human case of WNV infection has been reported in The Netherlands. Six additional cases have been identified, one of which from the region Arnhem. West Nile virus infection is a mosquito-borne zoonosis. The disease, which has spread across the Northern Hemisphere in the past three decades, is now found on an annual basis in many European countries where the centre of gravity lies in Southern-European countries. Recently, WNV was reported for the first time in Germany. The virus is transmitted among birds through the bite of infected mosquitoes and incidentally infects humans and other mammals, such as horses. Around 80% of human WNV infections are asymptomatic. The most common clinical presentation is West Nile fever but, older people and immunocompromised persons are at higher risk of developing neuro-invasive disorders (West Nile neuroinvasive disease). Currently, there are no prophylaxis or specific treatment against the disease in humans. In addition, Usutu virus (USUV) was detected in The Netherlands in 2016. USUV is another flavivirus, related to WNV, and also capable of infecting humans. Disease associated with USUV infection in humans appears to be milder and only limited number of cases have been identified. During their bird catching activities, bird ringers are intensively exposed to mosquito bites at the natural habitat of the birds and at the same time of the day when mosquitoes are particularly active. The aim of this study is therefore to determine the prevalence of WNV and USUV serum antibodies in bird ringers in The Netherlands.
The corona crisis has a negative impact on the mental wellbeing of the Dutch population. Positive psychology exercises (PPOs) can potentially improve mental well-being and reduce mild and moderate psychological complaints. Previous research has shown moderate to large effects of PPOs on well-being in people with reduced wellbeing and psychological symptoms at baseline. The University of Twente developed an app (Training in Positivity; TiP) based on an effective intervention. The goal of this study is to investigate the effectiveness of TiP in the general population in people experiencing reduced mental wellbeing as a result of the corona crisis. People using the app will be compared to a waiting list control group.
Nocebo effects are known to adversely affect the experience of various physical symptoms, such as pain and itch. Nocebo effects can be induced by associative learning mechanisms of classical conditioning. Furthermore, recent studies have shown that counterconditioning can successfully reduce nocebo effects, and to a larger extent than mere extinction, which suggests counterconditioning can be an innovative method for desensitization of symptoms. When using such procedures in clinical practice, deception of patients should be avoided as much as possible. The use of open-label procedures could provide a promising alternative. While previous studies have already shown that open-label placebos are effective, the effects of open-label counterconditioning and closed-label counterconditioning are not extensively investigated in comparison to other strategies, such as extinction, and not yet compared amongst each other. Before implementing such a procedure in clinical practice, it would be relevant to get an insight in the efficacy of both open- and closed-label counterconditioning in healthy participants as compared to extinction and to investigate whether open-label counterconditioning can be equally effective as closed-label counterconditioning. Furthermore, it would be relevant to study the induction and reduction of nocebo effects using a pain modality that mimics the type of pain that people suffering from several chronic pain conditions experience, such as pressure pain. The main aim of the current study is to investigate whether open- and closed-label counterconditioning are more effective in reducing nocebo effects than extinction. To this aim, it will be investigated whether open- and closed-label counterconditioning lead to stronger reductions in nocebo effects on pressure pain than (closed-label) extinction, and whether all three successfully reduce nocebo effects. Finally, it will be tested whether open- and closed label counterconditioning are comparable in effectivity.