There are about 13253 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.
Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.
The purpose of this study is to assess the long-term safety and tolerability of reldesemtiv in patients with ALS who have successfully completed dosing in the Phase 3 clinical trial, CY 5031 (also known as COURAGE-ALS)
The aim of this study is to determine the safety, tolerability and anti-tumoral activity of autologous T cells transduced with a T cell receptor specific for MAGE-A1 in eligible patients with advanced solid tumors.
This is a phase 1 study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of VIS171 in healthy participants and in participants with autoimmune disease(s).
Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.
This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in pediatric subjects with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterosomy). The OLE will continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of OCA. In addition, a change in vitamin A and D levels, and where possible the degree of change in liver stiffness, will be assessed during the OLE.
In two randomized clinical trials the investigators have demonstrated that continuous postoperative pericardial flushing (CPPF) therapy can reduce postoperative blood loss and bleeding-related complications after cardiac surgery and that CPPF therapy is safe and feasible in an experimental setting. The Haermonics investigational device is a novel medical device that enables CPPF therapy to be used in daily clinical setting. The aim of this study is three-fold. First, to evaluate the safety and functionality of the Haermonics investigational device. Secondly, to investigate the effect of CPPF therapy on bleeding related complications in the adulty cardiac surgery population. Thirdly, to explore the effect of CPPF therapy on intraluminal chest tube clogging.
Rationale: Increased albuminuria has a relatively high prevalence in the general population (5-9%) People with increased albuminuria are more likely to develop progressive kidney and cardiovascular disease compared to persons with no albuminuria. ACE-inhibitors or Angiotensin Receptor Blockers are recommended by clinical practice guidelines to lower albuminuria in patients with hypertension and diabetes. However, despite these drugs decrease albuminuria by approximately 30%, elevated albuminuria remains present in the substantial proportion of persons in the general population. SGLT2 inhibitors are a relatively new class of drugs. Originally they were developed as oral antihyperglycemic drugs. SGLT2 inhibitors have been demonstrated to lower albuminuria and protect the kidney in patients with established chronic kidney disease (CKD) with or without diabetes. Whether the efficacy of SGTL2 inhibitors to lower albuminuria (and possibly confer kidney protection) to persons in the general population (with or without diabetes or hypertension) with persistent albuminuria who generally are at early stages of CKD is unknown. Objective: To assess the albuminuria lowering effects of dapagliflozin in subjects with and without diabetes or hypertension and persistent elevated albuminuria. Study design: Randomized placebo-controlled double blind clinical trial of 24 weeks in duration followed by a 4 weeks wash-out period
This study is designed to evaluate the long-term safety and tolerability of REN001 administered once daily to subjects with PMM due to mitochondrial DNA mutations (mtDNA-PMM) or nuclear DNA mutations (nDNA-PMM). Subjects with mtDNA mutations will have previously completed Study REN001-201 or participated in Study REN001-101. Subjects with nDNA mutations who enroll in this study will be REN001- naïve.
Cystitis is the most frequent reason for women to visit their general practitioner. More than 600.000 women suffer from urinary tract infections in The Netherlands each year. Currently, the 1st choice treatment for uncomplicated cystitis is nitrofurantoin (NIT) for 5 days. The second choice is 3 gram fosfomycin-trometamol (FT) in a single dose. FT is increasingly prescribed because it has few side-effects and it has a patient-friendly dosing scheme. Previous research did not show significant difference in efficacy between fosfomycin and nitrofurantoin, but a clinical trial from 2018 claims a single dose of FT might be inferior to 5 days of nitrofurantoin. Pharmacodynamic and pharmacokinetic research suggests that a single dose of FT may be insufficient to cure cystitis. Overall, it remains unknown whether a single gift of FT is as efficacious as 5 days of nitrofurantoin for uncomplicated cystitis with regard to clinical cure and if an additional gift of FT would overcome this. A clinical trial is therefore warranted. Objective: To investigate the comparative effectiveness and side-effects of 5 days of nitrofurantoin, single dose FT, and extended use of FT in uncomplicated cystitis in primary care. Study design: An open-label randomized non-inferiority / superiority study with 3 arms. Study population: 777 non-pregnant women with symptoms of uncomplicated cystitis, with 259 subjects in each study arm. Intervention: (A) FT in a single dose of 3000mg on day 1; (B) extended dosing of 3000mg FT on day 1 and 3 (C) nitrofurantoin 100mg bid (slow release) for 5 days. Main study parameters/endpoints: primary: days of absence of cystitis symptoms within 28 days. Secondary: clinical failure on day 28, microbiological failure on day 28, incidence of side-effects, cost-effectiveness Burden and risks associated with participation, benefit and group relatedness: A potential risk of participation is that the treatment arm to which the patient is allocated is either less efficacious, has more adverse events or higher recurrence rate than the other treatment arms. However, NIT and FT are both frequently used for urinary tract infections and considered safe and effective compounds for uncomplicated cystitis. According to previous studies, a second dose of FT is well tolerated. The potential risks of participation on severe adverse events is expected to be negligible as the risk of severe clinical failure after cystitis treatment is only 1% according to previous studies and differences between NIT and FT have not been observed previously. A potential benefit of participating to this study is that a more patient friendly treatment scheme is equally effective. For future patients the guidelines could be improved and become more patient-friendly. The burden of participation is considered low. Study participants need to complete a short daily questionnaire on a mobile application up to 28 days.