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 aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea. The main question it aims to answer is: Does MMA surgery in OSA patiënts improve their quality of life? Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure.
SUMMARY Rationale: Quality of Care registries provide valuable insight in guideline adherence and implementation of guideline recommendations in routine clinical practice. Objective: The overall aim of the project is to study the titration of guideline directed medical therapy (GDMT) according to the European Society of Cardiology (ESC) HF 2021 guideline recommendations for patients with heart failure (HF) reduced ejection fraction (HFrEF), and mildly reduced ejection fraction (HFmrEF). Study design: The current study is a prospective multi-center national quality of care registry (longitudinal) of regular HF care (as given). Study population: The study population consists of patients with heart failure (de novo HF, chronic HF and worsening HF). Study setting is outpatient or inpatient (during admission). Patient sample is set at a minimum of 4000 patients, but can be expanded during the course of the registry project. Participating sites: all hospitals with dedicated HF outpatient clinic in the Netherlands can participate. Data: aggregated data Intervention: none / no Main study parameters/endpoints: The main parameters of quality of HF care are the adherence to guideline recommendation in terms of percentage (%) drug prescription, percentage (%) target dose (order, speed) and reason not to adhere to the guideline (intolerance, side-effects, maximum tolerated dose). The main endpoints for prognosis are the number of HF related hospitalizations and all-cause mortality during follow-up. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no risk in participation, no intervention and no active involvement of patients for specific activities in the study. The project is a registration of care as given (standard care) to the participating subject with heart failure.
Suffering from PTSD in childhood can have detrimental formative consequences. Researchers have been eager to develop effective interventions and to enhance treatment motivation since the introduction of the diagnosis of PTSD in the DSM. With evolving understanding of the disorder, its definition and criteria have changed over the course of time. The most recent change involves the addition of the criterium D of negative affects or emotions in relation to PTSD, the feeling of shame amongst others. Individuals experiencing interpersonal trauma, such as sexual abuse, are at high-risk developing trauma-related shame, which in turn can impact the course and effectiveness of PTSD treatment. Shame-inducing situations are typically being avoided, and the feelings are not disclosed to peers and other people. Hence, acknowledging and sharing feelings of shame as well as practicing self-compassion have been proposed to reduce the impact of that negative self-conscious emotion. These aspects get partially tackled in evidence-based trauma therapies, however, there appears to be a need for a more specific trauma-related shame intervention in addition to existing treatments. Recent research has focused on developing such interventions for adults and has reported positive effects. To our knowledge, there is no intervention specifically tackling trauma-related shame in adolescents. Virtual Reality (VR) is a promising tool for such an intervention. Findings suggest that including VR in a treatment results in high treatment satisfaction and that it is highly motivating for its users, which is a crucial component for treatment success. The goal of this study is to test the effectiveness of a short-term VR shame intervention (SHINE-VR) for adolescents suffering from PTSD after having experienced sexual abuse. The primary objectives of this study to assess the effect of SHINE-VR on trauma-related shame, self-compassion, and PTSD symptom reduction, to investigate whether treatment motivation, an increase in self-compassion, and a decrease in trauma-related shame are associated with PTSD symptom reduction, and the evaluation of SHINE-VR by assessing the feasibility of the intervention.
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
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.
Rationale: Acute stroke leaves many patients with functional deficits, of which upper extremity motor impairment is one of the most disabling. Evidence from imaging and electrophysiological studies converge on the idea that impaired motor function after stroke is associated with disrupted network activity in the brain. Non-invasive brain stimulation methods, like transcranial magnetic stimulation (TMS), can be used to restore disrupted network activity and have been shown to successfully facilitate recovery of motor function in patients with stroke. Application of continuous theta burst stimulation (cTBS), an inhibitory form of TMS, to the contralesional motor cortex has been shown to improve the recovery of motor function in patients with stroke. However, responsiveness to this treatment varies considerably between stroke patients and the mechanisms through which contralesional cTBS facilitates recovery of motor function remain unclear. Objective: To determine if contralesional cTBS normalizes interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex stroke patients with motor impairments. Age-matched healthy persons will serve as controls. Study design: A prospective, open-label within-subject intervention study Study population: 40 patients with first-ever ischemic stroke in one hemisphere and a unilateral paresis of the upper extremity, and 40 age-matched controls. Main endpoints: Primary endpoint: Interhemispheric inhibition from the contralesional to ipsilesional primary motor cortex. Secondary endpoints: contralesional intracortical inhibition; effect of contralesional TMS interference on finger tapping frequency.
Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward.
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.
Patients with type 2 diabetes have an increased risk of developing vascular complications. Microvascular dysfunction might be caused by the increased production of methylglyoxal under hyperglycaemic conditions. Methylglyoxal is a by-product of glycolysis and forms advanced glycation endproducts (AGEs) on proteins and DNA, thereby disrupting their function. Preventing methylglyoxal accumulation and AGEs formation may offer a therapeutic option for treating microvascular complications in diabetics. Pyridoxamine is a vitamin B6 vitamer that scavenges methylglyoxal and thereby inhibits the formation of AGEs. In this study, the researchers investigate whether pyridoxamine supplementation in type 2 diabetes improves microvascular function in the eye, kidney and skin, and reduces markers of endothelial dysfunction and glycation.
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants.