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 study is to investigate if tocolysis with atosiban in late preterm birth (30 to 34 weeks) is (cost-) effective compared with placebo in improving neonatal morbidity and mortality.
This study will investigate experimental colonisation with non-toxigenic C.difficile (NTCD) in healthy volunteers. Main outcomes will be safety, tolerability, dose needed to obtain colonisation with NTCD to ultimately determine host microbiota factors associated with susceptibility to colonisation.
Rationale: Research on novel methods to screen for esophageal adenocarcinoma (EAC) has expanded. Insight into individuals' drivers and barriers to attend screening is essential to tailor a potential new screening policy to their preferences. Public preferences should also be considered on the organizational level to guarantee client-centered decision-making in the design of the screening process. Objective: This study will examine Dutch individuals' intended uptake of EAC screening, including factors that predict uptake, and their views on its organization. Study design: Cross-sectional population-based survey. Study population: Dutch individuals aged 45-75 years. The required sample size is 2088 and 8350 individuals will be invited based on an assumed participation rate of 25%. Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey. Main study parameters/endpoints: The primary outcome of the study is the intended uptake of EAC screening (strong vs weak). Secondary study endpoints are the perceived need for consultation, perceived need for general education campaigns, acceptability of risk stratification scenarios, and acceptability of using health care resources for EAC screening. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 15 to 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.
Background Optimizing return to work (RTW) after knee arthroplasty (KA) is becoming increasingly important due to a growing incidence of KA and poor RTW outcomes after KA. We developed the Back At work After Surgery (BAAS) clinical pathway for optimized RTW after KA. Since the effectiveness and cost analysis of the BAAS clinical pathway are still unknown, analysis on effectiveness and costs of BAAS is imperative. Method This protocol paper has been written in line with the standards of Standard Protocol Items: Recommendations for Interventional Trails. To assess the effectiveness and cost-effectiveness for RTW, we will perform a multicenter prospective cohort study with patients who decided to receive a total KA (TKA) or an unicompartmental KA (UKA). To evaluate the effectiveness of BAAS regarding RTW, a comparison to usual care will be made using individual patient data on RTW from prospectively performed cohort studies in the Netherlands. Discussion One of the strengths of this study is that the feasibility for the BAAS clinical pathway was tested at first hand. Also, we will use validated questionnaires and functional tests to assess the patient's recovery using robust outcomes. Moreover, the intervention was performed in two hospitals serving the targeted patient group and to reduce selection bias and improve generalizability. The limitations of this study protocol are that the lead author has an active role as a medical case manager (MCM) in one of the hospitals. Additionally, we will use the data from other prospective Dutch cohort studies to compare our findings regarding RTW to usual care. Since we will not perform an RCT, we will use propensity analysis to reduce the bias due to possible differences between these cohorts.
This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.
The goal of this observational study is to gain insight in the natural course of pro-inflammatory factors and hemarthrosis in patients older than 18 with a recent knee trauma. The main question[s] it aims to answer are: - What is the natural course of pro-inflammatory factors and hemarthrosis in knee trauma? - What are the effects of inflammation and hemarthrosis on the anti-inflammatory potential of ASC's in order to better determine eligible patients and circumstances for ASC's therapy? Participants will: - undergo blood withdrawal - undergo knee arthrocentesis for synovial fluid sample collection - physical examination - fill out a questionnaire on knee complaints
The goals of this study is to 1) evaluate feasibility and fidelity of a three-arm RCT containing a twice-weekly exercise intervention supervised by a first-line (oncology) physiotherapist and a 5-day weekly in-hospital exercise intervention versus usual care in patients with rectal cancer or esophageal cancer receiving NCRT, and 2) generate preliminary data on the variability in exercise responses on immune function, immune infiltration, and vascularisation of the tumour. Participants will be randomized in one of three study arms: 1) AE + RE - group; combined moderate-to-high intensity aerobic exercise (AE) and resistance exercise (RE) twice a week supervised by a specially trained first-line physiotherapist, and a home-based moderate intensity aerobic exercise session once a week; 2) ExPR - group; in-hospital exercise intervention consisting of 30 min moderate intensity aerobic exercise within one hour prior to every radiotherapy session (five times a week); and 3) UC - group; a control group that receives usual care. The main study parameters will be the feasibility in terms of trial participation rate and attendance, and intervention fidelity (e.g. extend of and reasons for adaptations to the exercise intervention). The secondary study parameters are the average effect sizes and measures of variability on immune function, infiltration and vascularisation. Measurements will take place at baseline, directly after finishing NCRT, and within a week before surgery.
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a blood clot travelled to the brain in people who within the last 72 hours had: - an acute stroke due to a blood clot that formed outside the heart (acute non-cardioembolic ischemic stroke), or - TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic attack), and who are planned to receive standard of care therapy. Acute ischemic strokes or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain. They are caused by blood clots that travel to the brain and block the vessels that supply it. If these blood clots form elsewhere than in the heart, the stroke is called non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to have another stroke. This is why they are treated preventively with an antiplatelet therapy, the current standard of care. Antiplatelet medicines prevent platelets, components of blood clotting, from clumping together. Anticoagulants are another type of medicine that prevents blood clots from forming by interfering with a process known as coagulation (or blood clotting). The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care without increasing the risk of bleeding. The main purpose of this study is to learn whether asundexian works better than placebo at reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Another aim is to compare the occurrence of major bleeding events during the study between the asundexian and the placebo group. Major bleedings have a serious or even life-threatening impact on a person's health. Dependent on the treatment group, the participants will either take asundexian or placebo once a day for at least 3 months up to 31 months. Approximately every 3 months during the treatment period, either a phone call or a visit to the study site is scheduled on an alternating basis. In addition, one visit before and up to two visits after the treatment period are planned. During the study, the study team will: - Check vital signs such as blood pressure and heart rate - Examine the participants' heart health using an electrocardiogram (ECG) - Take blood samples - Ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study.
Rationale Globally, esophageal cancer is the seventh most common cancer type, with over half a million cases reported in 2020. The survival of gastroesophageal cancer is poor and the prognosis is primarily determined by the possibilities for curative treatment. After resection of part of the esophagus and cardia, the reconstruction of the esophagus is performed with a gastric conduit where an anastomosis is made with the proximal esophageal stump. Globally, a Minimally invasive Esophagectomy (MIE) has a high morbidity rate and a mortality rate ranging up to 5% as a result of the procedure. One of the most feared complications is an anastomotic leakage (AL) with a rate of around 12.5% and a mortality rate of around 15%. AL is associated with prolonged hospital stay and increased re-operation rates. It is generally accepted that impaired blood flow of the gastric conduit is the most important cause of AL. The surgical procedure of an esophagectomy and reconstruction inherently compromises the blood supply of the gastric conduit. However other than the surgical eye, there is no gold standard in assessing this. Surgeons generally look for traditional indicators of tissue viability such as pulsating vessels, bleeding of the resected edges, tissue color and intestinal motility. However, an objective indication of the tissue perfusion is still lacking, implying the clinical need for one. Objectives In this trial the investigators will study the utility of PerfusiX-Imaging for perfusion assessment of the gastric conduit in comparison with the standard of care. Study design The current study is a prospective, observational single-center study in the Medical Center Leeuwarden. Study population A total of 30 patients undergoing an esophageal resection will be included. Patient related study procedures All patients will undergo the standard-of-care program which includes perfusion assessment by the surgical eye and ICG-fluorescence imaging. In addition to this standard-of-care, 2D-perfusion maps will be generated from images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) in combination with a standard surgical laparoscope. Not related to the patient, the PerfusiX-Imaging images will be shown to the surgeon postoperatively and peroperative questionnaires will be filled regarding the standard-of-care perfusion assessment. Study parameters/endpoints Due to the explorative character of this study, there is no formal hierarchy in the respective endpoints of this study. In this, all endpoints will add to the overall assessment of the feasibility of the PerfusiX-imaging derived visual feedback. The investigators will look at the percentage of operating surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. The percentage of the non-involved surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. And the homogeneity of the change in location between non-involved surgeons for individual patients will be analyzed in order to get a sense for the subjectivity of the interpretation of the images. The investigators will also compare the additional PerfusiX-Imaging derived visual feedback to the standard of care by looking at the homogeneity in location of the watershed area between PerfusiX-Imaging, ICG-fluorescence and based on visual assessment by the surgical eye. The difference in the location of watershed area between PerfusiX-Imaging and ICG-fluorescence or based on visual assessment. In order to get a sense of the scale of the indicated change in location of the anastomosis the investigators will look at the estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by the operating surgeon. The estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by non-involved surgeons. Lastly, the investigators will compare the change in the location of the anastomosis by non-involved surgeons in comparison to the operating surgeon; Burden, risk and benefit to participation Burden Not applicable. Risks Not applicable. Benefit Not applicable.
Bevacizumab can be an effective treatment for individuals with NF2 and improve different nerve functions (like hearing, tinnitus or balance problems) and the quality of life of NF2 patients. However, bevacizumab is not effective in all patients or all tumors, at the cost of moderate toxicity and considerable financial burden. Therefore, this observational study will validate an imaging biomarker method to predict bevacizumab efficacy in order to avoid adverse effects and high costs in non-responders to bevacizumab treatment. Patients will undergo standard-of-care treatment with the sole addition of a pre-treatment 89Zr-Bevacizumab PET/CT-scan. Per standard-of-care bevacizumab therapy is administered every three weeks for six months. To monitor treatment effect, follow-up is performed at 3-month intervals.