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.
The objective of the current study, Vital@Work, is to keep employees in the Netherlands vital on the long term by preventing work-related mental health problems. Therefore, we test an evidence based Participatory Approach (PA) to compose a mental health program tailored to behavioral, organizational & contextual (BOC) determinants of individuals and populations at risk. The PA is investigated in four different organizations, which differ in sector, size (small and large organizations), type of organization (private or public) and type of work. The varied organizations, each characterized by unique BOC-determinants, provide an opportunity for researching tailored intervention activities that aim to effectively prevent work-related mental health problems. By identifying common factors across these diverse organizations, we aim to grasp patterns of mechanisms for interventions to mental health at work. By doing this, we come closer to opening black box of how and why interventions work and thus closer to tailoring interventions to needs of both individuals and organizations
Motive: In order to improve the treatment technique, a comprehensive follow-up program is needed to obtain all relevant patient, treatment and toxicity data from breast cancer patients. Goal:to set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. A standard database of patiënts receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment. To set-up and maintain a database containing treatment results in terms of tumor control, side effects, complications and patient-reported quality of life. A standard database of patients receiving photon treatment will be created. These data are then linked to dose-volume data of radiotherapy, with the aim to build prediction models for both tumor control and toxicity after radio (chemo) therapy that can later be used for selecting patients for proton treatment.
Type 2 diabetes mellitus is a highly prevalent disease, affecting over a million Dutch citizens, leading to severe micro- and macrovascular complications, reduced quality of life, and high healthcare costs. Clinical guidelines recommend a person-centered approach to improve (health)outcomes. However, with rapidly increasing treatment options, both in terms of medication and lifestyle interventions, shared decision making (SDM) is challenging in practice. Therefore, researchers have developed a multistage SDM program consisting of an online patient decision aid for type 2 diabetes mellitus, training for healthcare professionals in SDM, and a preparatory consult to provide patients with the knowledge and confidence to participate in SDM. Strong evidence of (cost)-effectiveness is a key requirement to achieve broad implementation of this program. This pilot study represents an important initial step towards high-quality economic evaluation research, with a focus on the diversity of the study population, burden on participating healthcare practices, and feasibility of outcome measurement.
The goal of this clinical trial is to evaluate stress and cardiovascular risk factors in women with preeclampsia in the medical history. The main questions it aims to answer are: - to improve our understanding of the underlying psychological and physical stress factors in relation to the circulatory risk profile in women with a history of preeclampsia - to examine the effects of mindfullness based stress reduction (MBSR) or aerobic exercise training on hair cortisol and symptoms of mental stress. Participants will undergo pre- and post-intervention pre-conceptional standard cardiovascular assessments, head tilt test and give a hair sample. As intervention they will sport or do mindfulness for 3 months.They will be compared with a control group.
G3P-01 is an investigational pectin extracted, enriched and purified from commercial squash puree intended for human consumption. Pectins are an important constituent of fruits and vegetables, and health benefits are attributed to its intake. Some of the health benefits of pectins are attributed to inhibition of galectin-3. This study investigates if 30-days of G3P-01 intake in individuals with elevated galectin-3 induces biomarker changes that can be attributed to target engagement. Participants will be randomized into four groups (placebo, 100mg, 250mg and 1000mg G3P-01).
The aim of this study is to evaluate the IFX exposure (AUC), effectiveness, presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator. Methods: this is a prospective, single centre, open-label cohort study, conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX (cohort 2). After the switch to SC CT-P13, patients are followed for 24 weeks. The study is subdivided into two phases: the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch. After enrolment, the subject receives a final dose of IV IFX according to their own maintenance schedule. Primary endpoints are the Area under the concentration-time curve (AUC) at steady state (1) before and after the switch to SC CT-P13 and (2) with or without concomitant immunomodulator during SC therapy. AUCs will be estimated using pharmacokinetic modelling in MwPharm. Besides IFX trough level, treatment related time expenditure, quality-of-life and patient satisfaction will be assessed before and after the switch.
The research questions this study aims to answer are as follows: Primary research question: "Do primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis with the 150mm Lubinus SPII hip stem have better mortality and stem revision rates than primary total hip arthroplasties with the 130mm hip stem?" Secondary aims include: - How does line-to-line cementation, compare to undersized cementation in primary total hip arthroplasty for patients with OA, hip fracture, or osteonecrosis when comparing equal size Lubinus SPII hip stems implanted with different cementation techniques? - Does the Lubinus SPII 150mm hip stem perform equal to the Lubinus SPII 130mm hip stem in primary total hip arthroplasties for patients with OA, hip fracture or osteonecrosis when comparing patient reported outcome measures? To answer these questions, this study has been allowed use of registered data from the LROI (dutch arthroplasty registry) and the SAR (swedish arthroplasty registry). After exclusion of patients who did not meet inclusion criteria between 2007-2020, approximately 110000 patients remain eligible for analysis.
This observational, prospective data collection is designed to evaluate the effectiveness and stimulation coverage of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with cervical lead placement.
The goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. By providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children. To achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the Netherlands) and also an international level from various countries in Europe.
The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients. The main question[s] it aims to answer are: Primary objective: In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation). Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention. Secondary objectives: Safety endpoint: Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation). A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.