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 risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT measurements provide information about bone structure, bone quality and bone strength in addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. Therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.
The purpose of this study is to explore the efficacy and safety of LTP001 in participants with pulmonary arterial hypertension (PAH) to determine if LTP001 has an adequate clinical profile to warrant further clinical development in this indication.
Rationale: Aging is accompanied by impairments in the sensitivity of skeletal muscle tissue to respond to the anabolic properties of protein feeding, which is suggested to result in age-related loss in muscle mass. Adequate muscle perfusion capacity is essential for muscle mass maintenance, as it determines the rapid delivery of amino acids, nutrients and growth factors to the muscle fiber, thereby stimulating muscle protein synthesis. However, muscle perfusion capacity declines with increasing age. Hence, improving muscle perfusion may be key to augment the sensitivity of senescent muscle following protein feeding in older adults. Although exercise training is an effective way to improve muscle perfusion capacity, there are a number of patient groups that find exercise training difficult to achieve. Hence, alternative strategies need to be developed to improve muscle perfusion capacity. Passive heat treatment (PHT) has been associated with various health benefits in older adult populations, including improved blood pressure, cardiovascular disease risk, and metabolic health. In addition, PHT has been shown to increase muscle fiber capillarization in healthy young adults. However, whether such an intervention improves muscle perfusion capacity, and enhances the anabolic response of skeletal muscle following food ingestion in older adults is unknown. Objective: To assess the impact of an 8-week passive heat treatment intervention on skeletal muscle fiber capillarization/perfusion capacity and post-prandial muscle protein synthesis rates in healthy older adults. Study design: single arm, within subject study design Study population: 14 healthy older (65-85 y) men and women. Intervention (if applicable): Participants will be subjected to an 8-week (3 x pw) PHT, by means of infrared sauna bathing, intervention. Before and after the PHT intervention the participants will undergo one test day during which blood pressure, body composition, physical function and muscle strength will be assessed. In addition, before and after the PHT intervention period subjects will be complete a 'whole-meal test day' during which the muscle protein synthesis and perfusion capacity response will be evaluated following the ingestion of a whole food meal. Basal and post-prandial muscle protein synthesis and perfusion capacity will be assessed by a continuous infusion of labelled amino acids combined with contrast-enhanced ultrasound measurements. Blood and muscle samples will be collected in order to assess the muscle protein synthetic response. Main study parameters/endpoints: The primary outcome will be post-prandial muscle protein synthesis rates following meal ingestion.
The aim of this study is to explore and evaluate the effects of an individually tailored intervention focusing on influencing dysfunctional illness perceptions and dysfunctional movement/pain behavior in patients with non-specific neck pain.
A study based on electronic heath records will evaluate the incidence and relative risk of safety concerns and adverse events of special interest (AESIs) following immunisation by AZD1222 in the real-world setting. A cohort and a self-controlled case series desings will be used.
The aim of this study is to determine the impact of the COVID-19 pandemic on the Dutch surgical care, expressed as number of performed procedures, altered treatment plans, and surgical outcomes in the Netherlands during the year 2020.
Rationale: In breast cancer, a sentinel node procedure is performed to investigate whether malignant cells have spread to the axillary lymph nodes. This is an important part of determining the stage of breast cancer and the final treatment plan. A disadvantage of the sentinel node procedure is that it is performed using radioactive tracing with concomitant radiation exposure for the patients and involved health care personnel. In addition, the use of radioactive tracing puts high demands on the logistics in the operation theatre: the capacity of patients that can be treated in one day is limited and the radio-active tracing leads to many time-consuming precautionary measures. A radiation free alternative would therefore have multiple advantages. Not only with respect to radiation exposure for the patients and health care workers, but also by reducing the waiting time for operation for the patients as it will make the planning of patients for surgery more efficient. Recently, a radiation free tracer for the sentinel node procedure has become available (Magtrace). This tracer has been tested in small-case studies and is currently used as standard care in several hospitals around the world. Objective: The primary objective of this study is to evaluate the diagnostic accuracy of Magtrace in the sentinel node procedure in breast cancer in the Breast Care Centre in Zuyderland Medical Centre; with the ultimate goal to make the sentinel node procedure a radiation free process. Study design: A prospective cohort of forty patients with breast cancer and an indication for a sentinel node procedure will be injected with both Technetium (radioisotope) and Magtrace (magnetic). All patients in this study will receive both tracers. Study population: Patients of 18 years or older with breast cancer and an indication for a sentinel node procedure will be included. These patients will be recruited by their breast surgeon in the outpatient department of the Breast Care Centre in Zuyderland Medical Centre. Intervention (if applicable): Sentinel node procedure using a magnetic tracer next to Technetium. Main study parameters/endpoints: The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer, measured by the sensitivity and specificity of Magtrace in detecting sentinel nodes with Technetium tracer as gold standard. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The goal of this project is evaluating the diagnostic accuracy of Magtrace in the sentinel node procedure. To establish that Magtrace is a non-inferior and a non-radioactive alternative for Technetium with respect to reliability in detecting metastases. The ultimate goal is to make the sentinel node procedure a radiation free process.
Rationale. Facial synkinesis is one of the most common consequences after facial paralysis, defined as the inability to move muscles due to nerve damage. Facial synkinesis arises during recovery of nerve injury and is characterized by involuntary and synchronous contractions of muscles during facial movements. Patients' quality of life is major influenced by the disease. As patients experience problems with facial movements, this leads to difficulties in expressing emotions, eating, and drinking. A common type of facial synkinesis is oral-ocular synkinesis, defined as eye closure during movement with the mouth. During movements of the mouth, the buccinator muscle plays an essential role. Both the trigeminal and the facial nerve innervate the buccinator muscle, resulting in a complex sensorimotor feedback system between the nerves. Dysregulation of this feedback system is assumed to result in hyperexcitability of the trigeminal and facial nuclei in the pons. In addition, this will lead to cortical plasticity of the sensory and motor areas of the brain. Based on this, the investigators hypothesize dysregulation of the sensorimotor feedback system in patients with facial synkinesis, resulting in differences in the neuroplastic organization of the primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex compared to healthy control participants. In addition, the investigators expect hyperexcitability of the trigeminal and facial nuclei. Therefore, this study aims to obtain a more detailed understanding of the neural reorganization of the sensory and motor areas as a consequence of facial synkinesis using 7T fMRI. Objective. To study the neuroplasticity of the brain due to facial synkinesis by assessing the somatotopy of the face on several cortexes of interest (primary and secondary somatosensory cortexes, the primary motor cortex, the supplementary motor cortex, and the ventral lateral premotor cortex) compared to healthy control participants. Study design. A single center imaging study carried out in MUMC+. Study population. Two patients with severe oral-ocular synkinesis will be included in this pilot study. In addition, two age- and sex-matched healthy control participants will be included. Intervention. Every subject will undergo a single functional MRI scan in the 7 Tesla MRI scan of Scannexus. A scanning session takes approximately 1 hour. During the scan, participants are asked to perform motor and sensory tasks. Main study parameters. The main study parameter is the hemodynamic response after stimulation of specific parts of the face. Within the areas of interest (primary motor cortex, the ventral lateral premotor cortex, the supplementary motor cortex, the primary somatosensory cortex (S1), and the secondary somatosensory cortex (S2)), the temporo-spatial brain activity patterns after the different motor and sensory tasks are assessed, and the representation of the face is mapped on the cortexes of interest.
It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.
This study aims to quantify the variation in postprandial AA profiles between (and within) individuals after consumption of a poorly digestible plant protein source (Lucerne) and to compare the variation in postprandial AA profiles between a poorly digestible plant protein source and an easy digestible protein source (whey). The study has a randomised, cross-over, controlled design. Two different treatments, all representing a 20g protein load, will be evaluated on five occasions with a washout period of minimum one week between the test days. On test days, research subjects will receive two different protein sources, in the form of a protein drink, in randomised order; on three test days they will receive a poor-digestible protein source, on two test days an easily digestible protein source. Blood will be collected via a catheter before and up-to four hours after protein consumption. Wellbeing, health complaints or other adverse effects will be collected via short questionnaires during each test day. After each test day gastrointestinal complaints will be collected via an online questionnaire.