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.
There is a need for better visualization of resection margins during surgery for soft tissue sarcoma. Optical molecular imaging of soft tissue sarcoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in soft tissue sarcoma versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling soft tissue sarcoma visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (10, 25 or 50mg) to detect soft tissue sarcoma intraoperatively.
The purpose of this double-masked, randomized, controlled, multiple-dose study is to evaluate the efficacy, safety, tolerability and systemic exposure of sepofarsen (QR-110) administered via intravitreal injection in subjects with Leber's Congenital Amaurosis (LCA) due to the CEP290 p.Cys998X mutation after 24 months of treatment
Research has shown that replacing sitting time with low intensity physical activity (such as slowly walking and standing) has beneficial effects on metabolic health, like insulin sensitivity, comparable to improvements after sitting all day in combination with 1h streneous exercise. The main objective of this study is to investigate the underlying mechanisms responsible for improved insulin sensitivity after 4 days of sitting less compared to sitting and exercise in healthy obese women. Our secondary objective is to investigate the effects of sitting less on cardio metabolic parameters.
Rationale: The annual incidence of ulcerative colitis (UC) amounts to 6-8 new cases per 100.000. Patients are initially treated medically, and colitis refractory to medical management is treated surgically, mostly by means of an (emergency) colectomy or a proctocolectomy with ileal J-pouch anastomosis. Over the past 10 years evidence has been accumulating indicating that the appendix has an immunomodulatory role in patients with UC reducing the need for medication and perhaps even colectomy. Objective: The objective of this prospective observational cohort study is to evaluate the effect of appendectomy on the disease course of patients with active ulcerative colitis despite standard step-up treatment including biologicals. The second objective is to determine if histological inflammation in the appendix resection specimens can be reliably predicted by pre-operative endoscopic biopsies of the appendix and correlated to clinical and pathological response after appendectomy. Study design: The design of the study is a prospective observational cohort study of 80 consecutive patients. Study population: Sixty patients of 18 years and older, with established diagnosis of UC and ongoing disease activity despite standard step-up treatment including biologicals. Furthermore, histological characteristics in appendix biopsies of 10 patients with non-active UC and 10 'healthy control' patients (e.g. patients undergoing endoscopy for polyps) will be evaluated and used as a reference control group. Intervention: Patients will undergo laparoscopic appendectomy in clinical or day care setting. Main study parameters/objectives: The primary outcome parameter is the number of patients achieving remission (Total Mayo score ≤2) 12 months after appendectomy. Secondary endpoints are reduction of medical therapy, the disease activity as measured with the Mayo score, colectomy rate, the health related quality of life and costs (EQ-5D, EORTC-QLQ-C30-QL and IBDQ), and histological appendix characteristics predictive of response.
The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis (CF).
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
An international multi-center prospective observational study to address safety and feasibility of an early discharge protocol in patients with symptomatic severe aortic stenosis who are eligible for transfemoral TAVI with the Boston Scientific ACURATE Neo Aortic Bioprosthesis transcatheter heart valve.
This is a multicenter home-based medical device intervention study, with prospective validation of the wearable seizure detection device (Nightwatch) and retrospective validation of remote sensors (video and audio detection) in children. The investigators will also perform a feasibility and utility analysis of Nightwatch.
The purpose of this study is to compare progression free survival rates of metastasized colorectal cancer patients refractory or intolerant to systemic therapy with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF therapy and anti-EGFR therapy (for tumours with wild-type KRAS)); randomized for treatment with TAS-102 (standard-arm) or High Dose Intermittent Sunitinib (700 mg once every 2 weeks). The investigators hypothesis is that treatment with the experimental arm (sunitinib) will provide an improvement in progression free in this patient group.
There is limited quality research on the effectiveness of treatments in Bowen's disease (BD). Patient and lesion characteristics, patient preferences and costs should be considered when choosing therapy. Surgical excision (SE), photodynamic therapy (PDT) and 5-fluorouracil (5FU) are mentioned as treatment options in guidelines. However no clear and evidence based recommendations are made in terms of effectiveness. Objective: The aim of this study is 1) to evaluate the (cost)effectiveness of 5FU and PDT compared to SE in BD and 2) to compare the effectiveness of 5FU with that of PDT. With a better understanding of the (cost)effectiveness of alternative treatment options, the investigators will supply the necessary evidence for national and international guidelines, to achieve more uniformity in treatment of BD. Study design: Randomized controlled non-inferiority multicenter trial. Study population: Patients ≥18 years, with a histological proven primary lesion of Bowen's disease, visiting Maastricht University Medical Centre, Catharina hospital Eindhoven, VieCuri MC Venlo or Zuyderland Medical Centre Heerlen. Intervention: One group undergoes SE with a 5mm safety margin followed by routine histological examination. The other group receives PDT with application of methyl aminolevulinate (MAL) cream followed by two illuminations with a one-week interval. The third group receives 5FU cream, which has to be applied by the patient twice daily for 4 weeks. Main study parameters/endpoints: The primary outcome is the proportion of patients with sustained clearance at 12 months post-treatment. Secondary outcomes are proportion of patients with clearance at 3 months, 3-year and 5-year probability of sustained clearance, cost-effectiveness, patient satisfaction, patient preferences, compliance, side effects and cosmetic outcome. Post-treatment, patients will be asked to answer a short questionnaire regarding side effects, experience with the treatment and satisfaction.