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 objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
Primary objective is to assess the impact of different reference glucose measurement methods on the measured performance of a CGM system, aiming at further standardization for the assessment of CGM systems. Secondary objective is to describe the relationship between glucose concentration of venous, capillary and arterialized-venous measurement samples. Study design: Open-label trial. Study population: Nineteen patients with type 1 diabetes aged 18 years and older will be included. Intervention: The study will use the Dexcom G5 Mobile CGM. The participant will visit the clinical research center (CRC) twice during a 6 day period. These visits will have a duration of 8 hours. Blood will be drawn for the determination of glucose concentrations using venous, arterialized-venous and capillary sampling techniques. The patient will receive his usual breakfast and an increased insulin bolus will be administered to correct the breakfast glucose excursion with the aim of inducing a period of minor hypoglycemia. Blood sampling will continue until the end of the admission. The sensor will be worn until the end of the second 8-hour CRC session, which will be planned on day 6 or earlier depending on patient preference. The sensor will be removed and their sensor and blood glucose meter data downloaded from the devices. In the case of sensor failure before the first CRC session, patients will be instructed to insert a new sensor per the manufacturer's instruction and to notify study staff of the event. In case of failure of the sensor after the first CRC session but before the second CRC session, patients will return to the CRC for sensor removal and for data download.
Colonization with Staphylococcus aureus is related to inflammation in atopic dermatitis. Gladskin is a product for topical use containing the proprietary enzyme Staphefekt SA.100, which has the ability to specifically lyse the cell wall of S. aureus. The investigators hypothesize that Staphefekt decreases S. aureus colonization of the skin and consequently decreases symptoms of atopic dermatitis.The goal of this study is to determine the effect of Staphefekt on the use of topical corticosteroids in patients with atopic dermatitis. Secondary goals are to retrieve information about the effect on clinical symptoms, quality of life, growth characteristics of Staphylococcus aureus and the further microbiome.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.
The objective of the study is to demonstrate the safety and feasibility of the Adagio Cryoablation System is subjects with Paroxysmal (PAF), Persistent (PsAF) and Long-Standing Persistent Atrial Fibrillation.
In patients with esophageal cancer (EC) neo-adjuvant chemoradiation (nCRT) followed by surgery with curative intent leads to objective responses in 45 to 60%, whereas 20-35% of the patients had no residual tumor (ypT0N0) at pathologic examination. The absolute survival benefit of response to nCRT is 15%, but still 14% of the patients develop locoregional failure in the CROSS trial. 18F-fluorodeoxyglucose positron emission tomography with computed tomography ((FDG-PET-CT) is able to distinct responders from non-responders, but still misses significant clinical evidence. Whole-body diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) has shown potential benefits, which might be enhanced by combining both methods. PET/CT and DWI-MRI more precisely correlate anatomic and metabolic FDG-avid lesions and seem to assess post-treatment changes, especially regarding nodal staging. Both techniques claim an important role in selection of patients with clinical complete response (cCR) and indirectly with pathologic complete response (pCR) after nCRT. However, the exact role and complementary effects of both techniques is still unknown. For appropriate judgment of response, secure standard endoscopic ultrasonography (EUS) with fine needle aspiration (FNA) / biopsy of potential suspected lesions, both nodal or residual tumor, seen on PET/CT or DWI/MRI or during EUS will be performed <2 weeks before surgery, approximately 6-10 weeks after nCRT and compared with the situation at primary staging. Patients with clinical complete response (cCR) resembling pathologic response (pCR= ypT0N0) after nCRT may refrain from surgical resection and related morbidity and mortality. However, patients without early (2wk after commencement) response during nCRT course may not benefit from nCRT. DWI-MRI seems effective in pre-treatment prediction of treatment outcome. Apparent diffusion coefficient (ADC), which indirectly measures tissue density, can be used to determine the likelihood of tumor response to treatment. High ADC before treatment has shown to predict an unfavorable response. Tumors with low ADC values on presentation generally respond better to treatment. An increased ADC in patients during and after nCRT could be used to predict early pathologic response i.e. discrimination of "responders and non-responders" to nCRT.
Arterial calcification is an independent predictor of coronary events associated with a 3-4 fold increased risk of cardiovascular events. Currently, no effective intervention exists to reduce arterial calcification. However, recent studies showed that vitamin K may reduce ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification. The primary objective is to determine if MK-7 supplementation leads to stabilization or attenuation of ongoing calcium deposition in the femoral artery as quantified by 18F-NaF PET/CT imaging in patients with type 2 diabetes and arterial disease.
Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The investigators' goal is to establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the investigators designed a trial in which patients scheduled for living donor nephrectomy are randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.
This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf) gametocyte carriers for Anopheles mosquitoes.
This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000 mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be hepatic and whole body insulin sensitivity. Secondary objectives, to provide information about the underlying mechanism, will be muscle mitochondrial function, brown fat activity, ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body composition and acetylcarnitine levels.