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.
To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
Environmental cleanliness As antimicrobial resistance is a major and overall deteriorating public health problem international cooperation is necessary. Continued progress is needed to implement and improve programmes for the prevention and control of antimicrobial resistance and HAIs. Environmental cleanliness might be one of the most important initiatives to reduce HAIs. Hospital surfaces are heavily contaminated with bacteria with the highest numbers on surfaces closest to the patients. Bed rails, nurse call buttons, curtains, towel dispensers, door handles, sinks, floors, clinical information stations, medical devices, stethoscopes, staff toilets etc. Actually, general hospital wards and Intensive Care Units are loaded with an abundance of potential pathogens 8,9,10. Surviving days, weeks or even months in the environment 11. Colonizing patients with bacteria from the hospital environment and getting HAIs or even die. As most ventilator-associated pneumonias (VAPs) are the result of nosocomial microorganisms the environment plays an important role in the acquisition of pathogenic bacteria by contaminating health care workers hands and equipment 12,13. Furthermore, ICUs and wards struggle with colonized patients with ESBL-bacteria from sinks eventually leading to dead or outbreaks of group A streptococcus infections from contaminated curtains 14,15. As key healthcare-associated pathogens have the capacity to persist for weeks to months on hospital surfaces indirect transmission is a serious threat, especially as antimicrobial resistance increases. Hospitalization in a room in which the previous patient had been colonized or infected with nosocomial pathogens (e.g. MRSA, VRE, multidrug-resistant Acinetobacter, Pseudomonas or C. difficile) has been shown to be a risk factor for colonization of infection with the same pathogen for the next patient16. Furthermore, the most important risk factor for hand and glove contamination of healthcare workers with multidrug-resistant bacteria has been demonstrated to be positive environmental cultures 17. To decrease the frequency and level of contamination of environmental surfaces the Centre for Disease Control and Prevention recommends routine disinfection of medical equipment and environmental surfaces to prevent the spread of potential pathogens through the hospital ward or ICU 18. Improved room cleaning has shown to decrease the risk for MRSA, VRE and C. difficile acquisition. Unfortunately, environmental cleaning is frequently inadequate. Less than 50% of hospital room surfaces are adequately cleaned and disinfected even by environmental services personnel. Environmental services personnel have low wages, are under time pressure to clean rooms quickly with high turn-over rates of patients. Novel materials and cleaning technologies have been developed as ultraviolet germicidal irradiation (UVGI) or hydrogen peroxide vapor (HPV). However, both technologies are expensive and can just be used for terminal cleaning and not during routine daily care 16. Self-disinfecting surfaces may overcome these problems. Once applied antimicrobial surfaces will continuously reduce the bioburden of nosocomial pathogens preventing transmission and decrease HAIs. MVX One of these self-disinfecting products is MVX. MVX contains titanium dioxide which by the use of nanotechnology is now available for use in the health sector. Working as a photocatalyticum it generates, in the presence of light, hydroxy radicals and oxygen radicals for at least five years after coating hospital surfaces (durability test TUV Rheinland). Laboratory tests show that MVX is effective in killing bacteria, viruses and fungi (see attachment 1 for summary test results). The positive results reported on the effects of MVX from laboratory evaluations still have to be confirmed in the clinical setting. After getting the CE-marking Gelderse Vallei Hospital in Ede, the Netherlands, will be the first hospital in Europe to study the efficacy of MVX in the Intensive Care Unit (ICU).
This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6). The primary objectives of this study are: - Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens - Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel - Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.
In this prospective single arm study the investigators will assess the feasibility of S-1 and Oxaliplatin as adjuvant treatment in patients with esophageal cancer. The primary objective is to assess the feasibility of administering adjuvant S-1 and Oxaliplatin (SOX) in patients with esophageal cancer after neoadjuvant chemoradiotherapy with paclitaxel and carboplatin and esophagectomy. Primary end point is the percentage of patients completing the preplanned number of 6 cycles of SOX.
Rationale: Colorectal cancer is the fourth most common cause of cancer death worldwide, estimated to be responsible for almost 610,000 deaths in 2008. Surgery remains the predominant curative treatment type for colorectal cancer, but has a major impact on the patient's wellbeing by demanding large amounts of metabolic reserves. This can lead to the development of frequently observed and severe postoperative complications. The most important complication after colorectal surgery is anastomotic leakage (AL), which has an incidence of 8-15% in the Netherlands. AL is associated with high short-term mortality rates of up to 40%. Even though many attempts have been made to reduce the incidence of this dreaded complication, none of these interventions have been successful so far. Despite proper patient selection and improvement in surgical techniques, the percentage of AL has been stable for years. Objectives: To investigate whether recently identified patient-specific factors can predict the occurrence of anastomotic leakage in patients undergoing elective surgery for colorectal cancer. Study design: Prospective observational study Study population: Adult colorectal cancer patients undergoing elective surgery. Main study parameters/endpoints: Primary endpoint: AL within 30 days postoperatively Secondary endpoints: Intestinal microbiome in fecal sample, I-FABP, SM22, Calprotectin, C-reactive protein(CRP), Citrullin, complement factors in blood, VOCs in exhaled air, COX-2 & MBL polymorphisms in buccal smear, L3-index & atherosclerosis measurements on CT-scans, SNAQ & MUST scores
This is a Phase 3, randomized, double blind, placebo controlled, parallel group, multicenter study in people with cystic fibrosis (CF) who are homozygous for the F508del CF transmembrane conductance regulator (CFTR) gene mutation.
Complex Regional Pain syndrome Type I (CRPS-I) is a chronic progressive disease. Patients experience dramatic decline of overall well-being, despite the absence of any apparent physical cause. The main symptoms are hypersensitivity to pain (hyperalgesia) and experiencing normal tactile stimulation as painful (allodynia) in the absence of peripheral nerve damage. The debate on the aetiology of CRPS-I is still open. The therapy offered to CRPS-I patients is diverse and can involve invasive and non-invasive interventions. Current (inter)national guidelines recommend physiotherapy as the best non-invasive treatment for rehabilitation. Recently, cognitive and behavioural Graded Exposure in Vivo (GEXP) therapy aimed at reducing pain-related fear was found to be effective (De Jong et al. 2005), and more effective than standard physical therapy (ReMOVE study, articles in preparation). By reducing pain-related fear EXP might reconcile motor output and sensory feedback. Another type of pain is lower back pain (LBP), which affects 70% to 85% of general population, but usually heals within 12 weeks in 90% of patients. The rest of the patients suffer from intractable, chronic LBP despite no evident organic abnormality. Research shows that also in these patients cognitive and behavioural aspects of pain are important and related to physical performance and self-reported disability (Vlaeyen et al., 2000). Several studies have demonstrated the success of GEXP in this patient group: GEXP resulted in improvements in pain-related fear, catastrophizing, performance of daily relevant activities, and in pain intensity (Leeuw et al., 2008). This study aims to investigate the effect of GEXP on brain regions involved in the processing of harmless tactile stimuli in CRPS-I and CLBP patients, as well as its effect on tactile discrimination thresholds. We hypothesize that GEXP will induce 1) an improvement of tactile discrimination thresholds, 2) a functional reorganization of primary and secondary somatosensory cortex (in regions related to the affected limb in CRPS-I; and to the back in LBP), 3) changes in activation of emotional brain circuits during non-noxious stimulation, 4) changes in resting state connectivity between emotional and sensory brain areas, 5) changes in measures reflecting white matter integrity. No systematic changes are expected in the healthy controls. Patients diagnosed with CRPS-I and CLBP will participate in a Magnetic Resonance Imaging (MRI) experiment. In this observational study, we examine the effects of GEXP treatment that all patients receive as part of usual care. Anatomical as well as diffusion-weighted and T2*-weighted (Blood oxygenation level dependent) MR images will be acquired. The study has a 3x4 split plot design with group (CRPS-I patients and CLBP receiving GEXP treatment / healthy controls) as between-subjects variable and time (pre-, during, post-treatment and follow-up) as within-subject variable.
The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chronic plaque psoriasis.
This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.
The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.