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.
This is a phase IB/II trial to examine feasibility and safety of checkpoint blockade (aPD1 with or without aCTLA4) neoadjuvant to standard of care (SOC) in advanced stage head and neck squamous cell carcinoma (HNSCC), a patient population in need for improved clinical outcome and in tumors likely to respond to neoadjuvant aPD1 and aCTLA4. In addition, with this research protocol the potential impact of intratumoral hypoxia on tumor infiltrating lymphocyte (TIL) abundance, differentiation and effector function will be assessed, and the potentially divergent effects of T cell checkpoint blockade in areas of hypoxia and normoxia.
Rationale: IBS is the most common functional gastrointestinal disorder with a prevalence worldwide ranging from 9-23%. Complaints include abdominal discomfort or pain and altered bowel habits. Although the condition is not life-threatening, it strongly impairs quality of life and up to now there is no cure for IBS. It is assumed that IBS symptoms are related to a combination of altered gut motility and secretion, and visceral hypersensitivity. However, its primary cause still remains largely unknown. The endocannabinoid system, together with some functionally related receptors is among the biological targets considered promising for treatment. Modulation of the CB1 , CB2 and related receptors or enzymes of the endocannabinoid system in a broader sense by (endo) cannabinoids or (and) structurally related lipid mediators can influence motility, secretions and decrease hypersensitivity in the gut. Among the plant-derived cannabinoids or so called 'phytocannabinoids', cannabidiol (CBD) is of special interest as it has shown therapeutic potential in preclinical studies and a growing number of case-reports. CBD is a non-specific phytocannabinoid displaying a broad but weak receptor interaction profile. In contrast to the well-known THC from Cannabis sativa, CBD is not psychoactive and often also present in those Cannabis varieties that are not used for their psychoactive properties but for industrial (fibre) or food properties (oil, flour and seeds) instead. Based on preclinical studies and in vitro data we hypothesize that CBD might be able to relieve symptoms of IBS, including pain in patients with IBS. The chewing gum is to be taken 'on demand' and may have some additional perceived positive effects. Objective: To investigate whether the use of a CBD-containing preparation in the form of CanChew® chewing gum can contribute to a reduction of IBS symptoms and an improvement of perceived wellbeing in patients with IBS. Study design: A randomized, double-blind, cross-over trial of 8 weeks in total. Study population: Adults, aged 18-65, diagnosed according to the ROME III criteria with Irritable Bowel Syndrome. Intervention (if applicable): Patients will, in this cross-over study, receive a maximum 6 chewing gums per day, either containing 50 mg of cannabidiol per chewing gum in case of the CanChew chewing gum, or a placebo chewing gum. This first intervention period will last 3 weeks. Next, participants will undergo a one week wash-out and then switch intervention to either placebo or the CanChew chewing gum for another 3 weeks. Main study parameters/endpoints: The main study parameter is a change in pain reduction perception experienced and measured by the patient using VAS-scales before and after taking the chewing gum, to be recorded in a diary. Next to this a patient is asked to provide one VAS score for each completed week. Furthermore, the adequate relief will be measured every day. At the end of each week patients will also be asked (from their diary) whether they noticed a change in stool frequency or (and) experienced any side-effects. For the disease-related quality of life the IBS-QOL will be used. This questionnaire will be filled out in week 1, 4, 5, and 8.
The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in healthy adult male participants after a single oral dose of 500 milligram (mg) 14C-JNJ-53718678.
Delirium is a common disorder in Intensive Care Unit (ICU) patients and is associated with serious short- and long-term consequences. This study focuses on a program of standardized nursing and physical therapy interventions to prevent delirium in the ICU, and determines the effect of the program on the number of delirium-coma-free days in 28 days and several secondary outcomes in a multicenter randomized controlled trial.
The obesity epidemic has led to a enormous increase in the prevalence of type 2 diabetes mellitus (T2D), dyslipidemia and cardiovascular events. Particularly South Asians, who comprise 1/5 of the world population, are at increased risk of developing a disadvantageous metabolic phenotype and these diseases. Moreover, T2D occurs at a younger age and at a lower BMI when compared to white Caucasians. Recent research has shown that South Asians not only have a lower energy expenditure than their Caucasian counterparts, but also less active brown adipose tissue (BAT). For some time, it has been known that adult humans have active BAT. This metabolic tissue produces heat by combusting triglycerides, in contrast to white adipose tissue, which stores this form of energy. It has been shown that activation of BAT has a positive effect on whole body metabolism, via increasing energy expenditure and improving glucose- and lipid metabolism. For this matter, BAT has been proposed as a major key player in energy homeostasis, which may be implemented in the current combat against the obesity epidemic. Aside from cold exposure, more research focuses on pharmacological activation of BAT. Glucagon-like peptide 1 (GLP-1) is an incretin hormone which is produced by intestinal L-cells and upon food intake stimulates insulin secretion by pancreatic beta cells. The GLP-1 analogue Exenatide is a currently much used antidiabetic drug to reduce hyperglycemia via this aforementioned mechanism. Beyond its blood glucose-improving effects, Exenatide has also shown to lower body weight and improve dyslipidemia in T2D patients. Elucidation of the underlying mechanism of these beneficial effects is highly relevant. Recent preclinical research in our group has shown that central activation of the GLP-1 receptor through exenatide increases BAT activity and thereby contributes to weight loss and improvement of dyslipidemia. The aim of this research project is to investigate whether exenatide is also able to activate BAT and increase resting energy expenditure, thereby improving glucose- and lipid metabolism and reducing fat mass and body weight in humans. Moreover, the investigators aim to validate the MRI scan as a novel way to measure BAT activity. The investigators hope that these forthcoming findings lead to the discovery of new treatment strategies against obesity.
The primary objective of this study was to assess the effect of cytochrome P450 3A4 enzyme (CYP3A4) induction by rifampicin on the pharmacokinetics (PK) of eribulin mesylate following intravenous (IV) administration in participants with advanced solid tumors. The secondary objectives of this study were to assess the safety of eribulin mesylate when co-administered with rifampicin and assess the safety and activity of eribulin mesylate as a single agent.
This study is being conducted to compare the relationship of patient response to treatment to changes in tumor environment.
In this study, the investigators propose to investigate a novel technique for fluid responsiveness prediction. It is based on the occurrence of an extra systole, which induces a preload variation: Extra systoles are comprised by, first, the premature/ectopic beat with decreased cardiac preload, then, the post-ectopic beat with moderately increased preload. Consequently, the post ectopic beat is associated with a Frank-Starling curve right shift but is otherwise a normal sinus beat. As such, the post-ectopic beat elucidates and predicts the hemodynamic effect of increasing preload, i.e. giving fluids
The purpose of this study is to explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).
This is a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the combination regimen of daratumumab plus durvalumab (D2). The study will consist of 2 parts; Part 1 has a 2-stage design while Part 2 consists of an expansion phase. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly [QW], every 2 weeks [Q2W] or every 4 weeks [Q4W] of each 28-day cycle) received on their last prior therapy containing DARA. The dosing schedule for DARA may be adjusted during the course of the study as outlined in the protocol. Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle.