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.
Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy combined with androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.
Rationale: Complication rates after major liver resections remain as high as 43%. Many initiatives have been taken to reduce postoperative morbidity. As such, prehabilitation programmes are increasingly used for patients undergoing major abdominal surgery. Improvement of aerobic fitness has been proven to reduce complication rates, especially in high-risk patients (those with a low preoperative aerobic capacity). Different conceptual hypotheses exist of the underlying mechanism of variability in postoperative complications and prehabilitation response. One of the complementary rationales focusses on homeostasis-allostasis before and after surgery, more specifically on the preoperative aerobic capacity to meet postoperative metabolic demands. However, more insight in postoperative metabolic demands (energy expenditure) during in-hospital recovery from major abdominal surgery in relation to preoperative resting metabolic demands and maximal aerobic capacity is essential to understand the increase in metabolic demands coinciding with major surgery in relation to the body's reserve capacity. This information can be used to better understand the rationale behind exercise prehabilitation, as well as to optimize the content of preoperative treatment for unfit patients, for instance by means of personalized prehabilitation programs that might improve postoperative outcomes. Objective: This study aims to explore the difference of pre- and postoperative energy expenditure in patients undergoing major elective liver resection and relate this to their preoperative aerobic capacity. Study design: The study will be a prospective observational study with thorough pre- and postoperative measurements of energy expenditure. Energy expenditure will be measured using the doubly labelled water method, as well as by indirect calorimetry. To assess aerobic capacity, cardiopulmonary exercise testing will be performed pre- and postoperatively. Additionally, accelerometers will be used to evaluate pre- and postoperative physical activity levels. Study population: Patients aged ≥18 years undergoing major liver resection (≥3 segments) will be asked to participate. The inability to perform cardiopulmonary exercise testing, neo-adjuvant chemotherapy, and cirrhotic liver are reasons for exclusion. Main study parameters/endpoints: The main study parameter is the difference of energy expenditure pre- and postoperatively, as measured with doubly labelled water and indirect calorimetry. Secondary endpoints: Additionally, as secondary endpoints, aerobic fitness, physical activity level, and postoperative complications will be assessed.
The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. The main research objectives of this study are: 1. To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery 2. To assess the safety and tolerability 3. To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging The study population will consist of patients, aged ≥18 years, diagnosed with high-grade glioma and scheduled for surgery.
The goal of this observational study is to investigate whether daily physical activities measured with a smartphone are related to the possible side effects or other physical complaints that arise as a result of cancer treatment. The investigators want to test whether the number of steps per day, both before and during treatment, are related to possible side effects or other physical complaints of the treatment using a smartphone. Knowledge about this relationship gives us possible starting points to prevent and/or reduce side effects and improve treatment outcomes. Additional research would then be needed. The investigators also want to investigate whether these daily measurements are feasible for patients undergoing treatment. Participation in the study involves measuring daily physical activity from the week before treatment until the first 3 months of treatment have been completed. This is done by tracking daily steps with patients own phone using the OncoSTAPP application.
Pancreatic ductal adenocarcinoma (PDAC) is estimated to become the second leading cause of cancer-related death by 2030. Effective management of PDAC is challenged by a combination of late diagnosis, lack of effective screening methods and high risk of early metastasis. Although systemic chemotherapy improves survival, 5-year survival is only 6%. Chemotherapy efficacy is attenuated by innate and acquired drug resistance of tumor cells, a strong desmoplastic reaction that limits local accessibility of drugs and a "cold" tumor microenvironment (TME) with high infiltrating levels of immunosuppressive cells. In PDAC, increased T cell exhaustion defined by increased PD-1/PD-L1 activity in both peripheral blood and tumor microenvironment, is associated with poor prognosis. Hence the rationale for targeting the PD-1/PD-L1 axis with the aim to release the "brake" and exert an anti-tumor response. In PDAC successful results with Immune Checkpoint Inhibition (ICI) monotherapy are limited and combination therapy with other agents is encouraged; specifically agents that induce dendritic cell priming. We hypothesize that combination therapy of ICI therapy with a toll like receptor 3 (TLR-3) agonist is a potential effective strategy. TLR-3 agonists are hypothesized to increase dendritic cell maturation and cross-priming naïve cytotoxic CD8 T cells while eliminating regulatory T-cell attraction, thereby acting as an immune-boosting agent. We propose that rintatolimod/durvalumab-combination therapy is feasible and may induce synergistic anti-tumor immune responses in PDAC.
The goal of this clinical trial is to test the effect of music in reducing the pain felt by newborn children during an intravenous line procedure. An intravenous line is a small tube brought into a vein by using a needle. The main questions it aims to answer are: 1. Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music? 2. How do parents and medical staff experience the music that's being played? Participants will all receive the same care and treatments as usual. The only difference being about half of the participants will be randomly assigned to the group that gets music. Researchers will compare the music group to the non-music group to see if there is any difference in vital signs and behaviors of the child.
The goal of this pilot clinical trial is to test the safety and effectiveness of genotype-guided clopidogrel monotherapy in patients presenting with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) who have undergone successful Percutaneous Coronary Intervention (PCI). The main questions it aims to answer are: - Is genotype-guided clopidogrel monotherapy effective in reducing ischemic risk during the first six months following successful PCI? - Is genotype-guided clopidogrel monotherapy safe in terms of reducing bleeding risk during the first six months following successful PCI? Participants will be given genotype-guided clopidogrel monotherapy after their successful PCI procedure and will be monitored for any bleeding or ischemic complications over the next six months. Researchers will compare these results to the typical outcomes associated with traditional Dual antiplatelet therapy (DAPT) to see if genotype-guided clopidogrel monotherapy provides similar or improved protection from ischemic events, but with fewer bleeding complications.
To report Cold intolerance by the CISS score in medicolegal patients.
The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.
This study aims to assess if a single flap peritoneum vaginoplasty is safe and feasible.The IDEAL framework for evaluation and implementation of surgical techniques will be used. There are two patient groups who are eligible to undergo this procedure. The first group consists of transgender women who either have a shortage of penile skin (so they cannot undergo standard operation technique: penile inversion) or a stenosis of their primary neovagina. The second group consists of women who are born without a vagina or have an acquired short or absent vagina after vaginectomy or hysterectomy because of malignancy of the cervix or vagina. At the moment, standard procedure for both groups in the Amsterdam University Medical Center (UMC) is the sigmoid vaginoplasty, where a part of the bowel is used to form a vaginal cavity. This procedure is risky, because in some cases, the bowel anastomosis is defect. An other more frequent complication, is malodorous excessive discharge. Sometimes accompanied by inflammation of the diversion neovagina. In recent years, the use of the peritoneum vaginoplasty has been described for transgender women. However, the peritoneum is either used as small flaps to deepen the vagina, or the peritoneum is pulled down, which limits the depth of the neovagina. We want to implement a different technique, where the peritoneum is harvested in a single pedicled flap, which is brought down and sutured in the cavity cylinder shaped. The risks are the same as in any laparoscopic surgery, but we suspect the risk of failure of the anastomosis is much lower, as is the chance of a temporary stoma.