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 Identifying emergency department (ED) patients at high and low risk shortly after admission could help decision-making regarding patient care. Several clinical risk scores and triage systems for stratification of patients have been developed, but often underperform in clinical practice. Moreover, most of these risk scores only have been diagnostically validated in an observational cohort, but never have been evaluated for their actual clinical impact. In a recent retrospective study that was conducted in the Maastricht University Medical Center (MUMC+), a novel clinical risk score, the RISKINDEX, was introduced that predicted 31-day mortality of sepsis patients presenting to an ED. The RISKINDEX hereby also outperformed internal medicine specialists. Observational follow-up studies underlined the potential of the risk score. However, it remains unknown to what extent these models have any beneficial value when it is actually implemented in clinical practice. Objective To determine the diagnostic accuracy, policy changes and clinical impact of the RISKINDEX as basis to conduct a large scale, multi-center randomised trial. Study design The MARS-ED study is designed as a multi-center, randomized, open-label, non-inferiority pilot clinical trial. Study population Adult patients who are assessed and treated by an internal medicine specialist in the ED of whom a minimum of 4 different laboratory results (hematology or clinical chemistry, required for calculation of ML risk score) are available within the first two hours of the ED visit. Intervention Physicians will be presented with the ML risk score (the RISKINDEX) of the patients they are actively treating, directly after assessment of regular diagnostics has taken place. Main study parameters Primary - Diagnostic accuracy, policy changes and clinical impact of a novel clinical risk score (the RISKINDEX) Secondary - Policy changes due to presentation of ML score (treatment policy, requesting ancillary investigations, treatment restrictions (i.e., no intubation or resuscitation) - Intensive care (ICU) and medium care (MC) admission - Length of admission - Mortality within 31 days - Readmission - Patient preference - Feasibility of novel clinical risk score
Unexpected intensive care unit (ICU) readmission is associated with longer length of stay and increased mortality. Bedside decision support may prevent readmission and mortality and may allow optimizing ICU capacity. Using a recently developed and prospectively validated machine learning model that predicts ICU readmission and mortality rate after ICU discharge and shows trends in these predictions over time, we will evaluate the implementation of the European conformity (CE)-marked software based on this model (Pacmed Critical, Pacmed, Amsterdam) by investigating whether the software improves diagnostic accuracy compared to routine clinical evaluation by the treatment team and whether availability of the information from this software leads to changes in discharge management (either postponing or advancing discharge) for patients considered eligible for discharge.
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Rationale: The complication rate after pancreatic resection is high, especially in elderly and physically unfit patients. Aerobic capacity, as indicated by the ventilatory anaerobic threshold (VAT) assessed by a cardiopulmonary exercise test (CPET), can be used to identify high-risk patients. Previous studies have demonstrated that exercise prehabilitation can increase aerobic capacity in patients scheduled for intra-abdominal surgery, subsequently leading to better treatment outcomes. There is limited evidence on the feasibility of a (partly) supervised home-based prehabilitation program in patients scheduled for pancreatic resection. Objective: The primary objective of this study is to assess the feasibility of a four-week supervised home-based prehabilitation program in patients scheduled for elective pancreatic resection. Secondary objectives are to evaluate individual responses to prehabilitation on a number of secondary endpoints (no cause-effect relationship to be established). Study design: This study is a pragmatic multicenter study with a pretest-posttest design. It will take place at the Maastricht University Medical Center+ and University Medical Center Groningen in the Netherlands, and at the 'Città della Salute e della Scienza' in Torino, Italy. Study population: Patients planned for elective resection of a pancreatic tumor will be screened for potential eligibility. High-risk patients, identified by an oxygen uptake (VO2) at VAT ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min, will be asked to participate. Intervention: A total of 45 patients will participate in a four-week (partly) supervised home-based personalized exercise training program before surgery (12 sessions in total). An advanced cycle ergometer (Lode Corival, Lode BV, Groningen, the Netherlands) will be delivered at the patient's home. Three weekly sessions of high-intensity interval training on the cycle will be combined with functional task exercise training. A trained physical therapist will visit the patient at least weekly to monitor progress. Main study parameters: The main study parameter is feasibility of the (partly) supervised home-based prehabilitation program. Hereto participation rate and reasons for non-participation will be evaluated. In participating patients, adherence/compliance, dropout rate, reasons for dropout, adverse events, patient motivation, and patient and therapist appreciation will be assessed throughout the program. Secondary endpoints: Secondary endpoints before and after prehabilitation include aerobic capacity, muscle function, body composition, functional mobility, immune system function, perceived fatigue, quality of life, and sarcopenia. Data on patient characteristics, neoadjuvant therapy, surgical procedure, and postoperative outcomes will also be collected for explorative purposes.
This study aims to investigate whether the use of medical checklists in the emergency department can decrease resuscitation time in critically ill patients.
TRICOLON is an investigator initiated, prospective, interventional, open-label, randomized, real-world, multi-centre, 3-arms study in the Netherlands. The primary objective is to investigate in COPD patients if single-inhaler triple therapy (SITT) is superior to multi-inhaler triple therapy (MITT) in terms of adherence to inhaled corticosteroids (ICS) therapy and to investigate if SITT with e-health support is superior to MITT and SITT without e-health support.
The aim of the study is to determine whether conducting a randomized placebo-controlled clinical trial is feasible, safe for the patient and whether the treatment is well tolerated in patients with idiopathic pulmonary arterial hypertension.
Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.
In an effort to prevent surgery in selected patients with esophageal cancer, the SANO-2 study offers active surveillance to patients with clinically complete response (cCR) after neoadjuvant chemoradiation (nCRT). Some of these patients will never develop locoregional and/or distant recurrence of disease (persistent cCR). However, two-thirds of the patients that undergo active surveillance still get disease recurrence. This can be locoregional regrowth or distant metastases. To increase the efficacy of active surveillance (reduce the proportion of patients that need surgery) and improve survival, effective systemic maintenance therapy is needed. The CheckMate 577 randomized, placebo controlled, clinical trial showed that Nivolumab increases disease free survival in patients after nCRT and esophagectomy. Objective: To assess the efficacy of nivolumab during active surveillance in patients with cCR after neoadjuvant chemoradiation for esophageal cancer
The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints. In the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.