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.
In the Netherlands, most men with prostate cancer (PCa) are treated with radical whole-gland treatment, i.e. prostatectomy or radiotherapy. The burden of complications such as incontinence and erectile dysfunction associated with radical treatment is considerable. A recent systematic review by our group has shown that focal therapy of PCa seems to reduce the burden of treatment side-effects in men with intermediate-risk disease, maintaining their quality of life without compromising oncological effectiveness. The costs of side effects that can be prevented are estimated at €5456 per patient, resulting in total expected cost savings of about €22 million per year in The Netherlands. Furthermore, exploration of the benefit-risk balance under patients showed that they are willing to sacrifice some survival for an improvement in quality of life (QoL). Focal therapy comprises a modern alternative to selectively treat a specific part of the prostate while preserving the rest of the gland. There is, however, a lack of high-quality evidence, and numerous papers therefore recommend to perform a multicenter randomized controlled trial (RCT). The RCT should have long-term follow-up, predefined assessment of cancer-specific and health-related QoL outcome measures, and economic evaluations to inform policymakers regarding cost-effectiveness. This RCT on focal therapy versus usual care is urgently needed to enable focal therapy to overgrow the experimental status, provide the evidence needed for guidelines, and make this available for selected patients who benefit from this strategy. Because of its promising results in other countries, focal therapy is increasingly requested by patients, but due to the lack of high-quality evidence, it is not reimbursed yet. This has been designated by both the PCa patient support group and physicians as a failure of both the market and the funding agencies. The investigators, therefore, aim to perform a high-quality multi-center RCT to provide the evidence needed to decide on reimbursement and implementation of focal therapy in patients with intermediate-risk, unilateral clinically localized PCa in the Netherlands.
The study hypothesizes that human who are both breastfeeding and pumping in the first days postpartum have more expression volume with an additional 5 minutes of pumping with Maintain program after pumping with the INITIATE program.
Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment works by blocking the mutated EGFR and HER2 protein present in NSCLC cells and may help stop the further spread of NSCLC. BAY2927088 is under development, once it is approved, it may help treat people with NSCLC. The participants of this study will be healthy men and will have no benefit from the administration of BAY2927088. However, the study will provide important information for the design of subsequent studies with BAY2927088 in people with NSCLC. The participants in this study will get the non-radiolabeled and radio-labeled study treatment BAY2927088 in the form of tablets and solution by mouth and as an intravenous infusion in the arm. By radiolabeling the study treatment, researchers can track its movement and breakdown in the body of the participants. During the study, the study team will do physical examinations, take medical history, ask the participants questions about their smoking or alcohol consumption habits and other medications used, check vital signs such as blood pressure, heart rate, body temperature and the number of breaths taken per minute (respiratory rate), take blood and urine samples, do HIV (human immunodeficiency virus), hepatitis and optional COVID-19 tests per local regulations, and examine heart health using electrocardiogram (ECG). Each study participant will go through a first test phase (screening) of up to 28 days before the start of treatment. The study will have two parts. In part 1, the study participants will take a single dose of the non-radiolabeled study treatment in the form of tablets by mouth 30 minutes following a light meal. They will then receive the radiolabeled study treatment as an intravenous infusion in the arm over 15 minutes. After 2 days of washout, the same group of participants will move on to Part 2 of the study. They will take a single dose of the radio-labeled study treatment as a solution by mouth 30 minutes after a light meal. The participants and the study team know what treatment the participants will take. The total duration of the study will be approximately 8 weeks per participant, including an in house stay of approximately 23 days and 22 nights. There will be a final examination on the last day of their in-house stay before the participants are discharged and go home. The study doctors and their team will contact the participant to learn about the participant's health until the participant completes the study.
Rationale: OCLs (osteochondral lesions) of the talus can be congenital or can occur after trauma or in patients with juvenile idiopathic arthritis (JIA). The main complaint of an OCL is pain during weightbearing activities. Therefore, these lesions have significant impact on the health status of patients. Objective: The aim of this study is to optimize the treatment for skeletally immature patients with an osteochondral lesion. The hypothesis is that a period of immobilization and supervised rehabilitation will lead to better clinical and radiological outcomes compared with standard care which is a ''skill-full'' neglect. Study design: Observational comparative study Study population: Skeletally immature children with an osteochondral lesion of the talus diagnosed on CT. Intervention: Patients in the intervention group will undergo an 8-week period of casting and walking on crutches. Afterwards, they will receive a protocolled period of rehabilitation under supervision of a physical therapist. The control group will have the standard care as treatment. Main study parameters/endpoints: the main study outcome is the difference between the two groups on the OxAFQ-C. Secondary study outcomes are radiologic changes in terms of morphology and lesion size, NRS during weight bearing and quality of life measured with a Peds-QL, EQ-5D-y and AAS. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden that patients will have is mainly the time that they have to spent on fulfilling the questionnaires.
Train-METASTRA is a retrospective study that will be performed in order to collect a large and harmonised amount of clinical and imaging data concerning vertebral metastases, focusing in particular on the risk of fractures. This type of dataset will be created from the medical records of 2000 patients admitted in the last ten years in the four European clinical centers participating in METASTRA project: "COMPUTER-AIDED EFFECTIVE FRACTURE RISK STRATIFICATION OF PATIENTS WITH VERTEBRAL METASTASES FOR PERSONALISED TREATMENT THROUGH ROBUST COMPUTATIONAL MODELS VALIDATED IN CLINICAL SETTINGS", funded by the European Union under the call "HORIZON-HLTH-2022-TOOL-12-two-stage/Computational models for new patient stratification strategies". The project is coordinated by the University of Bologna (UNIBO) (PI prof. Luca Cristofolini) and involves 15 European partners, including Sarl Voisin Consulting Life Sciences VCLS, University of Szeged (Hungary), University of Sheffield (UK) and FrontEndART (Hungary). This type of dataset is not currently available in the literature and it will be pivotal to the development of the METASTRA computational models for the stratification of the risk of fracture of patients affected by spinal metastases.
Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity. Thereby patients treated for this malignancy are at double the risk of developing symptomatic heart failure / cardiomyopathy when compared to the general population. This corresponds to a cumulative incidence of 5-10% within 5-years after receiving R-CHOP. In the elderly, an incidence of 26% has been reported after 8-years of follow-up. Among patients who die in complete remission, heart failure has been described to be one of the most important causes of death. ANTICIPATE aims to evaluate if dexrazoxane can prevent AICD in DLBCL patients and identify those at highest risk of AICD. Of all patients treated with anthracyclines in a first-line setting, DLBCL patients were chosen for this trial for two primary reasons. Firstly, these patients have a favourable oncological prognosis with a 5-year relative survival in the Netherlands of 64-78% in those aged 18-74 years increasing the importance of preventing long-term toxicity. Secondly, the cumulative anthracycline dose used for the treatment of DLBCL is higher than the dose used in breast cancer. The cumulative anthracycline dose is the most important risk factor for AICD known.
The global burden of stroke is staggering, with over 15M new cases reported annually. Of these cases, around 40% require motor and cognitive rehabilitation, resulting in approximately 6M new patients requiring treatment each year, in addition to the more than 33M chronic patients worldwide. This massive incidence puts great pressure on healthcare systems and mounting costs. Consequently, there is an urgent need for patient-specific solutions that maximize rehabilitation efficiency and improve the patient´s performance, activities of daily living (ADLs), and quality of life. While several technological solutions have been proposed for stroke recovery during hospitalization, there is a notable lack of attention to home rehabilitation, which is crucial for long-term recovery, cost reduction and minimizing the demand for rehabilitation personnel. Investigators propose NEST, the Neurorehabilitation Ecosystem for Sustained Treatment based on the Rehabilitation Gaming System (RGS), an advanced digital rehabilitation program that uses serious gaming and Augmented Reality (AR)- and Virtual Reality VR-based training and is grounded on neuroscientific principles, that has been shown to promote motor recovery after stroke at the clinic and at home (Ballester et al., 2017; Ballester et al., 2019). NEST uses a patient's user model solution interfaced via a novel digital and portable technology to provide a home rehabilitation program accepted by the patients and clinicians. The NEST system integrates the following components: - RGS-wear advances a multimodal unobtrusive wearable interface starting from the state-of-the-art wearable technologies including off-the-shelf wearables for the detection of arm activity. This data is sent through Bluetooth to a paired smartphone, which allows for the filtering of body movements. - The RGS-Mobile App (smartphones) communicates with the RGS-wear and integrates sensor data for the delivery of patient-tailored Augmented Reality AR-based exercises for motor and cognitive training, customized feedback via the AWA coach, and activity reports through the MIMS. - The AWA Coach (Agent for Wellbeing Assistance) which provides specific feedback based on the performance and the status of well-being of the user. The user can access information through the AWA Coach dashboard (AWAtar App), which is an interface that reports their performance. and progress. It also provides the user with direct and motivational feedback and training activities in order to assist them in acting when needed. - MIMS (Medical Information Management System) is a cloud service in which relevant information on the patient's state is uploaded, allowing the monitoring of progress and the customization of the RGS-based training and evaluation protocols. Guaranteeing the correct use of this NEST ecosystem by post-stroke patients performing upper limb telerehabilitation implies conducting an usability study to measure its usability, adherence, acceptance and the user's experience. Investigators will also explore effectiveness of the NEST ecosystem in improving motor function of the paretic arm after stroke. Furthermore, uncovering end-user's experiences with NEST in an international multi-centre study should give valuable information into improving its features for a future clinical trial focusing on the effectiveness of the NEST system. This multicenter study will follow a mixed methods approach (quantitative and qualitative measurements).
Mental health consists of the absence of mental disorders and the presence of mental well-being. However; mental health care currently focuses mainly on mental disorders and less on promoting mental well-being. And yet people with personality problems often score very low on well-being. In order to work on sustainable mental health, attention is needed for both mental complaints and well-being and this is achieved through promoting psychological adaptation. Psychological adaptation is the process in which a person deals in a healthy way with their own needs, emotions and inner signals (such as stress) as well as the smaller or larger challenges in life. For people with personality problems psychological adaptation is also low, they mainly react in rigid patterns. Creative arts and psychomotor therapies (CAPTS) are a non-verbal form of therapy in which various creative methods, such as theater, sports, dance, music and sports methods, are used to make contact with emotions and to practice healthier ways of dealing with them. This is very suitable for working on promoting psychological adaptivity, within a safe and playful context. It's about doing and experiencing, and discovering what works for you personally, more than talking and understanding. That this is effective is endorsed by professionals and clients in mental health care, but scientific evidence is still scarce. That is why a specially developed, CAPTS module for people with personality problems will be investigated in a mixed methods design. We focus on both effectiveness and working mechanisms in a Multiple Baseline Single Case Experimental Design and a qualitative approach.
The present study aims to quantify the insulin sensitivity and the skeletal muscle protein synthetic response to consuming a test drink containing all amino acids or all amino acids except for BCAAs.
This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with [89Zr]crefmirlimab berdoxam PET imaging as an imaging biomarker.