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 overall objective of this study is to describe the incidence of postoperative pulmonary complications in patients with a positive and negative AIR-test result. Second, the investigators wish to describe the incidence of a positive AIR-test and its association with the development of PPC. In addition, the investigators aim to describe whether mechanical ventilation strategy differs between patients with a positive and negative AIR-test.
Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events. Currently, mitral valve repair surgery is the ultimate treatment for severe primary mitral valve insufficiency. The main indications and timing for surgery are severe mitral valve insufficiency with symptoms or left ventricular dysfunction. However, the role of atrial fibrosis in this process remains undetermined despite its well-recognized clinical implications. Characterization of atrial fibrosis patterns in mitral valve insufficiency patients might be potentially valuable for the indication and timing of mitral valve repair surgery in order to improve clinical outcomes. To date, however, mitral valve insufficiency patients suffering from left atrial remodeling have hardly been studied using these new imaging techniques. Therefore, the investigators intend to combine advanced cardiac MRI and post-processing techniques prior to and after mitral valve repair surgery to gain more insight in the clinical implications of atrial fibrosis in this patient population. It is hypothesized that the atrial fibrosis surface area paradoxically will increase after mitral valve surgery because of global shrinkage of the left atrium caused by the reversed remodeling process. As a consequence, more frequently atrial fibrosis related events including (paroxysmal) atrial fibrillation, may be observed in these patients. Objective: To assess the effects of (reduced) volume overload on the left atrial wall texture (presence, amount and location of atrial fibrosis) and associated geometry and function in patients with mitral valve insufficiency, prior to and after mitral valve repair surgery. Study design: Single center pilot study. Study population: The research population consists of mitral valve insufficiency patients scheduled for elective surgical mitral valve repair (N=20) according to the current European guideline criteria.
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in these women.
The primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels with removal of dietary protein restriction and alternative pathway medication.
Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. Supposedly, the tip of a GDD tube with a thinner diameter, such as the Paul implant, will remain at a larger distance from the cornea and, thereby, cause less damage. Objective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD. Study design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise, both GDDs will probably have a similar risk/benefit profile. The risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.
Rationale: Patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease (CAD). In addition to high healthcare costs, some of the examinations do not assess the presence of CAD, which means that patients may be undertreated and are at risk for myocardial infarction. A uniform diagnostic and treatment strategy that uses computed tomography coronary angiography (CTCA) as initial examination may reduce major adverse cardiac events (MACE) and may reduce healthcare costs. In addition, we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms (CAG's). Objectives: - To show that the intervention is non-inferior to the control with regards to clinical outcomes - To show superiority of the intervention with regards to clinical outcomes Study design: National multicenter prospective randomized controlled trial. Study population: Patients with suspected stable CAD. Intervention: upfront CTCA to diagnose CAD and guide optimal medical therapy (OMT). Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization. Control: Standard of care. Diagnosis and treatment are at the discretion of the attending cardiologist. Main study end point: Composite of all-cause mortality and non-fatal myocardial infarction.
Enzalutamide is one of the oncolytic drugs that showed efficacy and safety in most of the features of prostate cancer. Approximately 17% of the patients treated with enzalutamide need pain control. Nearly all opioids are metabolized through one of the CYP enzymes induced by enzalutamide, making optimal pain management difficult. For pain control, while using enzalutamide, morphine is being advised since morphine is mainly glucuronidated by UGT2B7 and to a lesser extent UGT1A1. Enzalutamide is in vitro an inducer of UGT1A1 and may inhibit UGT2B7 which could alter morphine concentrations, though the clinical relevance of this interaction is unknown. In patients with cancer, Direct Oral Anticoagulants (DOACs) are frequently used since vitamin-K antagonists were reported less effective than DOACs in preventing thromboembolic events. However, DOACs are all metabolized through CYP3A4 or P-gp. Due to interaction potential with DOACs, patients treated with enzalutamide are switched to Low Molecular Weight Heparin (LMWHs) administered subcutaneously which is considered safe but less patient friendly. For patients comfort DOACs are preferred over the use of LMWHs. Since rivaroxaban and apixaban are both major substrates for CYP3A4, combination with enzalutamide is prohibited. Dabigatran is a DOAC which is only metabolized by P-gp and edoxaban is a minor substrate for CYP3A4. Therefore, both might be safe to combine with enzalutamide. However, in patients with an active malignancy edoxaban is preferred according to national guidelines. Still, it is unknown if enzalutamide has a significant effect on the edoxaban exposure. The purpose of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics.
Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension. Therefore, aim of this study is to assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.
In this pharmacokinetic/pharmacodynamic modelling study we will determine the ability of intranasal and intramuscular naloxone to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in healthy volunteers and chronic opioid users to develop dosing recommendations in case of opioid-induced respiratory depression from an opioid overdose in clinical practice and in the out-of-hospital overdose.
Rationale: Clemastine fumarate has been identified as potential remyelinating therapy for multiple sclerosis (MS). The (long-term) effects of clemastine need to be confirmed in clinical models for MS. Internuclear ophthalmoparesis (INO) may be used as a clinical model for investigating remyelinating therapies by measuring horizontal eye movements with infrared oculography. Furthermore, infrared oculography combined with a single dose of fampridine may be used to identify individuals with MS that are most likely to benefit from remyelinating therapy. Objective: To assess the (long-term) efficacy of clemastine fumarate in improving dysconjugacy of eye movements in patients with internuclear ophthalmoparesis and multiple sclerosis. Secondly, to assess whether a response to a single dose of fampridine can predict the effects of clemastine treatment. Study design: A single-centre double-blind randomized placebo-controlled trial consisting of a 6 months (180 days) treatment period followed by a 30 months follow-up period. Study population: 80 MS patients, age 18-70 years, with INO. Intervention: The intervention group will receive 4 mg of clemastine fumarate twice daily (8 mg/day) for 6 months (180 days), the control group will receive an equivalent amount of placebo. At baseline all participants will receive a single 10 mg dose of fampridine. Main study parameters/endpoints: The primary outcome measure is the change in versional dysconjugacy index (VDI) of area under the curve (AUC) measured by infrared oculography. Secondary outcome measures include changes in other VDI measures (peak velocity per amplitude (PV/Am) and peak velocity (PV)), changes in VDI after single fampridine dose, other oculography parameters (e.g. saccadic latency, anti-saccades), (peripheral) retinal nerve fibre layer (pRNFL) and (macular) ganglion cell inner plexiform layer (mGCIPL) thickness measured by OCT, SDMT, EDSS, high and low contrast visual acuity, subjective visual functioning (NEI-VFQ-25 and NOV-AU questionnaire), quality of life (EQ5D-5L) and fatigue (CIS20R and NFI-MS questionnaire). Nature and extent of the burden and risks: Participation in the study will consist of a total of 7 study visits. Study visits will include physical/neurological examination, infrared oculography, OCT, visual acuity tests, a cognition test (SDMT), 5 questionnaires and blood samples for safety laboratory tests. Considering both clemastine and fampridine are registered and well-established drugs and have been used in clinical practice, the estimated risk of unexpected adverse reactions is low.