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: Hypoglycaemia is the most frequent complication of insulin treatment in individuals with type 1 diabetes and a limiting factor for achieving optimal glycaemic control. When recurrent, hypoglycaemia can induce a process of habituation, leading to impaired awareness of hypoglycaemia (IAH), a process that can be reversed by meticulous avoidance of hypoglycaemia. In the past 5-10 years, the use of continuous real-time (RT-CGM) or flash glucose monitoring (FGM) has increased rapidly in the clinical management of type 1 diabetes to improve overall glycaemic control and reduce the frequency of hypoglycaemic events, in particular in patients with IAH. It is unknown, however, whether the use of these devices, as well as other improvements in clinical management, has reduced the prevalence IAH and exposure to severe hypoglycaemia (SH) in subjects with type 1 diabetes in a real-world setting. Therefore, it becomes highly appropriate to investigate the current state of IAH and SH in type 1 diabetes. Also, since invites to this study will specifically include people who have taken part of previous assessments, this study will be able to investigate the change in IAH over time and the potential contributing role of RT-CGM/FGM. Furthermore, we want to explore associations of IAH and SH with clinical parameters, quality of life and psychosocial impact. This knowledge will help people with diabetes and their healthcare providers to better adjust treatment recommendations to individual targets. Objective: The primary objective of our study is to investigate the current prevalence of IAH and exposure to severe hypoglycaemia in individuals with diabetes type 1. The secondary objectives of our study are to: - Study the difference in IAH prevalence over time in individuals with diabetes type 1. - Assess the association of RT-CGM/FGM with IAH and SH. - Study thoughts, emotions and worries which lead to a certain behaviour in case of hypoglycaemia and prevention of hypoglycaemia. - Study associations of IAH and history of SH with productivity in different situations (work/study, relation/sexuality, driving behaviour/traffic and sport/leisure). - Study association between partner involvement and handling in case of (unawareness for) hypoglycaemia. - Study knowledge of subjects with diabetes about hypoglycaemia and IAH. - Study burden of IAH and severe hypoglycaemia on family members of people with type 1 diabetes, as experienced by patients themselves. Study design: This study will be a cross-sectional observational cohort study. The study will be conducted at the Radboud university medical center, department of internal medicine. Subjects with type 1 diabetes will be recruited from outpatient diabetes clinic as well as subjects who participated in two earlier cohorts and agreed to be approached again. Study population: The study population will be individuals with diabetes type 1, older than sixteen years old. Main study parameters/endpoints The main study parameter will be the current prevalence of IAH and exposure to severe hypoglycaemia in the past 12 months.
Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.
The PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria.
This study evaluates the effect of regulating salt and protein intake on urinevolume in patients with ADPKD treated with a vasopressine V2 receptor antagonist (V2RA). The investigators hypothesize that changing sodium and protein intake will reduce V2RA-induced polyuria.
This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.
This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
This is a phase 2 study, designed as a European multicentre 6-month double blind random-ized controlled trial (RCT) of AZD0530 versus matched placebo, followed by a 12 month trial comparing open-label extended AZD0530 treatment with historical control data. Study population: Male and female adult patients aged 18 years and older with a diagnosis of FOP who meet the inclusion (active disease) and exclusion criteria will be eligible for participation in this study. The total number of enrolled patients will be 20. Intervention: Patients will be randomized to receive either AZD0530 100mg once daily or matched placebo, taken orally for the first 6 months, immediately followed by an open-label extension in which all patients will receive AZD0530 100mg once daily oral dose for a further 12 months. Endpoints: Endpoints include objective change in heterotopic bone volume measured by low-dose whole-body computer tomography (CT) , [18F] NaF Positron Emission Tomography (PET) activity and patient reported outcome measures.
The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.
ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.
The purpose of this study is to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (HAE).