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.
As one of the few centers, MAASTRO also aggressively re-treats patients with recurrent non-small cell lung cancer. Even after primary radical treatment to high doses, re-irradiation (with concurrent chemotherapy) is also given in curative intent, thus again using high doses of radiation. Publications on high-dose re-irradiation of lung cancer patients are scarce, and outcome and toxicity for patients treated in MAASTRO are unknown at present. This study will provide knowledge on benefit and risks of such a therapeutic approach.
Rationale: Sudden cardiac death, mainly caused by ventricular arrhythmias (VA), is a major cause of morbidity and mortality in non-ischemic cardiomyopathy (NICM). Therapies that effectively prevent VA are lacking. Improved understanding of the substrate and mechanisms of VA in NICM may allow more effective, individualized and substrate-based therapies to be developed. In addition, risk stratification in NICM needs to be improved so that therapies can be allocated more efficiently. Objectives: 1) To improve our understanding of the underlying pro-arrhythmic substrate and electrophysiologic mechanisms of VA in NICM, and to develop individualized treatment for VA based on the identified substrate. 2) To improve risk stratification for VA and sudden cardiac death in NICM based on substrate characteristics. 3) to evaluate disease progression in NICM. Hypothesis: Improved understanding of the substrate and mechanisms of VA in NICM may allow more effective, individualized and substrate-based therapies to be developed. Study design: A prospective cohort study. Study population: The study population will consist of three groups (A, B and C): NICM patients with documented VA, suspected VA or intermediate to high risk for VA (according to established criteria) who are not referred for cardiac surgery (group A), NICM patients with documented VA, suspected VA or a high risk for VA who are referred for cardiac surgery (group B) and a control group consisting of patients without NICM who are referred for cardiac surgery (group C). Evaluation: All patients will be evaluated according to current standards for patients with NICM. Evaluation will include 24h-Holter, echocardiography, coronary angiogram and contrast-enhanced MRI (CE-MRI). If CE-MRI is performed in another hospital, additional recordings will be performed in our hospital. Additionally, blood samples (arterial, cardiac venous and peripheral venous) for collagen turnover markers will be taken from all patients. 123-iodine metaiodobenzylguanidine (123-I MIBG) imaging, electrophysiologic study and endomyocardial biopsy will be performed in group A and B. Intra-operative biopsy will be performed in group B and C. Intervention: In group B, intra-operative mapping and cryo-ablation and postoperative electrophysiologic study will be performed in patients with subepicardial late enhancement on MRI or induced VA suspected for an subepicardial origin. Main study parameters/endpoints: The main study parameters are extent, location and pattern of fibrosis on imaging and in biopsy specimens. The main study endpoints are inducibility of VA, type of induced VA, spontaneous VA and type of spontaneous VA.
Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis. The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response. Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker. We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment. The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.
This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.
Lung cancer is the most common cancer type worldwide, with more than 1.1 million annual deaths. There are two types of the disease, namely non-small cell lung cancer (NSCLC) and small-cell lung cancer (SCLC), with the first accounting for 85% of the total number of cases. The 5-year survival across stages remains disappointingly low, around 10% in most countries, due to a high incidence of both loco-regional and distant failure [3]. However, during the last decade improved radiotherapy techniques allowed an increase of the radiation dose, while at the same time more effective chemo radiation schemes are being applied. These developments have lead to improved outcome in terms of survival. As the TNM staging system is highly inaccurate for the prediction of survival outcome for non-surgical patients, attempts have been made to develop a more accurate risk stratification for these patients [1,2]. A model based on clinical variables yielded an AUC of 0.74, which was encouraging, but also left room for improvement [2]. An extended model, which included clinical as well as biomarker variables, reached a higher AUC, but the limited number of patients included in this study made it impossible to draw definitive conclusions [1]. New prognostic parameters can be retrieved from several sources, which include anatomic, molecular and functional imaging, genomics, proteomics and clinical analysis of patients. The unlimited amount of information is expected to lead to more accurate predictions of individual treatment outcome [4]. The analysis of biomarkers, including proteins, is a fast developing, promising and challenging area of research. Biomarkers can measure or evaluate normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention. Oncoproteins are produced by, or in response to tumor cells, and may be secreted in the circulation of patients. As tissue sampling is often not possible in lung cancer patients, blood sample collection by venepuncture offers an attractive alternative, which is safe and easy to implement. A number of studies described the prognostic and predictive value of blood biomarkers for NSCLC [5-7]. In this study we will investigate the prognostic value of blood biomarkers related to 1) hypoxia: Osteopontin (OPN), carbonic anhydrase IX (CA-9), and lactate dehydrogenase (LDH); 2) inflammation - interleukin 6 (IL-6), IL-8, and C-reactive protein (CRP), and α-2-macroglobulin (α-2M); and 3) tumor load: Carcinoembryonic antigen (CEA) and cytokeratin fragment (CYFRA 21-1). 1. Dehing-Oberije C, Aerts H, Yu S, De Ruysscher D, Menheere P, Hilvo M, et al. Development and validation of a prognostic model using blood biomarker information for prediction of survival of non-small-cell lung cancer patients treated with combined chemotherapy and radiation or radiotherapy alone (NCT00181519, NCT00573040, and NCT00572325). Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):360-368. 2. Dehing-Oberije C, Yu S, De Ruysscher D, Meersschout S, Van Beek K, Lievens Y, et al. Development and external validation of prognostic model for 2-year survival of non-small-cell lung cancer patients treated with chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2009 Jun 1;74(2):355-362. 3. Travis WD, Brambilla E, Müller-Hermelink HK, Harris CC. World Health Organization Classification of Tumours: Pathology and Genetics of Tumours of the Lung, Pleura, Thymus and Heart. Paul Kleihues MD, Leslie H. Sobin MD, editors. Lyon, France: IARC Press, International Agency for Research on Cancer; 2004. 4. Lambin P, Rios-Velazquez E, Leijenaar R, Carvalho S, van Stiphout RG, Granton P, et al. Radiomics: extracting more information from medical images using advanced feature analysis. Eur J Cancer. 2012 Mar;48(4):441-446. 5. Donati V, Boldrini L, Dell'Omodarme M, Prati MC, Faviana P, Camacci T, et al. Osteopontin expression and prognostic significance in non-small cell lung cancer. Clin Cancer Res. 2005 Sep 15;11(18):6459-6465. 6. Muley T, Fetz TH, Dienemann H, Hoffmann H, Herth FJ, Meister M, et al. Tumor volume and tumor marker index based on CYFRA 21-1 and CEA are strong prognostic factors in operated early stage NSCLC. Lung Cancer. 2008 Jun;60(3):408-415. 7. Pine SR, Mechanic LE, Enewold L, Chaturvedi AK, Katki HA, Zheng YL, et al. Increased levels of circulating interleukin 6, interleukin 8, C-reactive protein, and risk of lung cancer. J Natl Cancer Inst. 2011 Jul 20;103(14):1112-1122.
The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.
An open randomized phase III study to compare 8 continuous cycles of chemotherapy with 8 cycles of intermittent (2 times 4 cycles) chemotherapy in first line treatment, in combination with bevacizumab, and second line treatment of patients with HER2/neu negative, incurable, metastatic or unresectable locally advanced breast cancer.
Medically unexplained symptoms (MUS) are a common and important problem in primary care. Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful tests, referrals and treatment. Evidence indicate that specific interventions for patients with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited help. According to experts in this field a multi-component approach is most helpful for these patients. This pilot trial aims to test the systematic identification of eligible patients, to assess the acceptability of the intervention and to estimate potential treatment effects for a larger trial. It's a randomised pilot study consisting of patients with MUS in primary care. Patients will be randomized to intervention (usual care and additional psychosomatic therapy) or control condition (usual care alone). Patients will be followed for one year. Participants are patients consulting their GP more than once with MUS and in which the GP presumes that psychosocial distress is an underlying cause. The intervention is the psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS. Primary outcome measures are: the number of patients identified and recruited, perceived symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated symptoms of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional Symptom Questionnaire). Other primary outcome measures are the time needed to include the eligible patients, the number of withdrawals in the intervention and control group, compliance in the therapy group and the number of patients who complete the questionnaires. Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation List), physical and mental health status and quality of life (SF-36), and level of functioning (MAF: measure of general functioning). Patient satisfaction with the received therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the Cost Diary for medical consumption.
Rationale: Cardiac surgery with extracorporeal circulation (ECC) triggers platelets. Minimal extracorporeal circulation system (minimal-ECC) has several advantages compared with conventional ECC amongst less platelet activation. Platelet function can be analysed with thromboelastography (TEG) and multiple electrode aggregometry (MEA). Objective: The use of minimal ECC leads to less platelet dysfunction compared with conventional ECC in coronary artery bypass grafting (CABG) analysed with TEG and MEA Study design: Single center, prospective, randomized, pilot study Study population: Group 1: 20 patients undergoing CABG using minimal ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative. Group 2: 20 patients undergoing CABG using conventional ECC. Patients continued the use of acetylsalicylic acid and discontinued the use of clopidogrel minimal 5 days preoperative. Intervention: Group 1: CABG using minimal ECC Group 2: CABG using conventional ECC Main study parameters/endpoints: 1. Results of TEG and MEA, see detailed description 2. Per operative blood loss and total blood loss 24 hours after CABG 3. Total amount of transfused platelet units during CABG and 24 hours after CABG