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 present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation.
Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks. Paravalvular leakage after TAVI is relatively common and there is conflicting evidence regarding the clinical impact of mild paravalvular leakage in self-expanding devices. Prospective data for self-expanding devices are required to compare the extent of paravalvular leakage as a result of device design. Grading paravalvular leakage after TAVI is difficult. Echocardiography and angiography systematically underestimate paravalvular leakage (PVL) as compared to cardiac MRI. Hemodynamic measurements are used to aid decision making directly after TAVI implantation. Prospective data comparing hemodynamic measurements with cardiac MRI are needed to design an optimal strategy to grade paravalvular leakage peri-operatively in order to optimize TAVI outcomes. The combination of aortic valve stenosis, angiodysplasia and von Willebrand Disease type 2A (vWD-2A) is known as Heyde syndrome. Previous studies have shown a decrease in angiodysplastic lesions after TAVI. However, since PVL after TAVI is relatively common, angiodysplastic lesions tend to reoccur. Prospective data comparing the severity of PVL to the severity of both vWD-2A and angiodysplasia are lacking. Objective: To assess procedural hemodynamic measurements in patients with paravalvular regurgitation quantified by means of cardiac MRI (CMR) and to analyse its association with impaired clinical outcome during 5-year follow-up. Secondary objectives are to assess whether the severity of vWD-2A correlates with the severity of PVL measured by cardiac MRI, and to prospectively assess the success percentage of TAVI in the treatment of angiodysplasia. Study design: This is a prospective, single-center clinical trial. Patients will receive a TAVI. After implantation different hemodynamic indices of PVL will be assessed. Within 4-8 weeks after TAVI a cardiac MRI will be performed to quantify the amount of PVL. Standardized clinical follow-up will take place at discharge, 30 days, 3 months, 6 months and 1 year. Telephone follow-up will take place at 2, 3, 4 and 5 years after TAVI. In patients with known angiodysplasia or iron deficiency anemia e.c.i., a videocapsule endoscopy (VCE) will take place before TAVI and 6 months after TAVI. Of note, for the substudy on Heyde syndrome, patients with a different type of TAVI valve (i.e. no Abbott Portico valve) are also allowed to participate. Study population: Approximately 80 patients with severe symptomatic aortic valve stenosis with an indication for TAVI will be included. At least 76 patients with a cardiac MRI that is of sufficient quality to quantify the amount of PVL will be included. Intervention: Patients will undergo cardiac MRI on top of standard clinical care within 4-8 weeks after TAVI. A subgroup of patients will also undergo a VCE. Main study parameters/endpoints: The primary endpoint is defined as PVL regurgitation fraction as measured by cardiac MRI. One secondary endpoint will comprise a composite of device success, early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2) (1) and will comprise death, vascular complications, stroke/TIA, life-threatening bleeding requiring transfusion, and acute kidney injury requiring dialysis. Another secondary endpoint will be the reduction of angiodysplastic lesions after TAVI as determined by VCE. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The hemodynamic indices can be assessed in a standard fashion using a fluid filled pigtail catheter that is placed in the left ventricle as part of the routine protocol. Following TAVI, enrolled patients will undergo cardiac MRI to assess PVL. The risk of cardiac MRI after TAVI implantation is negligible. Extra blood samples will be taken. After one year, patients will be followed by telephonic follow-up. Risk/benefit: the expected benefit is a structured clinical follow-up at 1, 2, 3, 4 and 5 years, at the cost of an extra visit to undergo cardiac MRI.
This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.
The obesity epidemic calls for new therapeutic opportunities to prevent and treat obesity and its comorbidities amongst which are insulin resistance and cardiovascular diseases. Recent evidence suggests that tissue oxygenation plays an important role in cardiometabolic health. Remarkably, individuals residing at high altitude (hypobaric hypoxia) are less prone to develop type 2 diabetes mellitus as compared to individuals living at sea-level (normobaric normoxia). Furthermore, there is evidence to suggest that normobaric hypoxia exposure may improve glucose homeostasis and insulin sensitivity in both rodents and humans. The level of physical activity is an important determinant of insulin sensitivity and glucose homeostasis. It is well established that performing physical activity improves glucose uptake in the short term, and glycemic control in the long term. Interestingly, recent studies have demonstrated that an acute bout of exercise under hypoxic conditions (inhalation of air containing less oxygen) may lead to a more pronounced improvement in plasma glucose concentrations and/or insulin sensitivity as compared to normoxic exercise. However, the effects of repeated hypoxic exercise bouts on glucose profile throughout the day (i.e. 24h continuous glucose monitoring) remain elusive. In the present randomized, placebo-controlled, single-blind, cross-over study study, the investigators will investigate the effects of exercise under mild normobaric hypoxic conditions (FiO2, 15%) for 4 consecutive days (2 x 30-min cycling session at 50% WMAX) on postprandial substrate metabolism and 24h-glucose level in overweight/obese subjects with impaired glucose tolerance. The investigators hypothesize that 4 consecutive days of exposure to mild hypoxia while performing moderate intensity exercise improves glucose homeostasis in overweight and obese individuals with impaired glucose homeostasis.
This is the open-label extension study of phase II ARGX-113-1802 to evaluate the long-term safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP. Patients already stabilized on efgartigimod PH20 SC will also have the opportunity to participate in a sub study to explore less frequent dosing of efgartigimod PH20 SC.
Rationale: Foods that can be eaten at a fast rate - with low mastication effort - lead to shorter orosensory exposure (OSE) per unit of food consumed. This results in a decreased satiation response and higher subsequent food intake. Recent research has shown that participants on a ultra-processed diet have an higher caloric intake and gain body weight compared to those on an unprocessed food diet. In this study the ultra-processed vs. unprocessed meals were classified according to the NOVA classification and matched on caloric content and palatability. The NOVA classification, classifies foods based on the physical, biological and chemical processes that occur after foods are separated from nature, and before they are consumed or used in the preparation of dishes and meals. However, it remains unclear whether the found increase in food intake of ultra-processed foods is due to industrial processing or because of a difference in eating rate at which the (ultra-)processed foods can be consumed. Objective: The objective of this study is to determine the independent and additive effects of industrial food processing (according to the NOVA classification) and eating rate on satiation. Study design: The study has a 2x2 randomized crossover design. All participants receive 4 treatments and are their own control. Study population: Healthy adults (n=60) between 18-55 years old with a BMI between 18.5-27 kg/m2. Intervention: Participants will join 4 test days during which they receive 3 main test meals (breakfast, lunch, dinner) and in-between meals snacks according to one of the 4 diets. The 4 diets of this study are: 1) unprocessed, slow eating rate 2) unprocessed, fast eating rate 3) ultra-processed, slow eating rate 4) ultra- processed, fast eating rate. During eating and before and after eating the weight of the plate will be measured to determine intake. Additionally, participants will be recorded on video to determine eating behaviour (number of bites, chews and oral processing duration). The order in which participants will receive the diets will be randomized. The evening before and during each test day participants will keep a food and exercise diary. Main study parameters/endpoints: The main study outcomes are food intake during the three main meals and during snack time. Secondary outcomes are, eating behaviour characteristics measured by video (eating rate (g/min and bites/min), number of chews (chews/bite and chews/gram), bite size (gram/bite), oral processing duration (seconds), appetite (hunger, fullness, desire to eat, desire to eat sweet, desire to eat savoury, prospective consumption) and sensory characteristics (liking (taste + smell), desire to eat the meal, expected satiation, sweet, savoury, smoothness, chewiness, thickness) of the meals. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk associated with participation is small and the burden can be considered as moderate. The knowledge obtained may be used to develop products or strategies that enhance healthy choices and eating behaviour and consequently help prevent overweight and obesity. We consider the knowledge obtained and possible implications of this study to outweigh the individual burden.
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA. The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB in all patients.
Recently, three-dimensional scanning of the torso has been proposed as an alternative for two-view chest radiographies and computed tomography to determine the severity of pectus excavatum without exposure to ionizing radiation. The range of three-dimensional scanning systems is broad with even varying systems being used within hospitals. Most of these scanning systems have been validated for accuracy and reproducibility, no comparison between these systems is known. In addition, severity measures of pectus excavatum, as well as other research outcomes, surgical planning techniques, and analysis methods are based on a single imaging system. It is subsequently essential to determine whether different imaging systems can be used interchangeably regarding accuracy and reproducibility. The aim of this study was to assess the reproducibility and accuracy between three commonly used three-dimensional scanning systems.
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of INCB057643 as monotherapy or combination with ruxolitinib for participants with myelofibrosis (MF) and other myeloid neoplasms.
Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.