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.
Rationale: The immune system in the ageing population becomes compromised with age (termed "Immunosenescence"). Therefore, elderly people have a decreased ability to respond to infection and vaccination. Furthermore, many of the health issues associated with ageing are linked to inflammation ("Inflammaging"). It has been suggested that this compromised immune function is in part due to reduced Toll-like receptor (TLR) function, which is part of the innate immune system. Milk and dairy based products have been shown to have beneficial effects on inflammation and immunity. This effect may be mediated via support of the innate immune response and promotes TLR7 signaling in in vitro assays (unpublished observation). Also prebiotics have been suggested to influence markers of innate immune function. Furthermore, TLR function has been suggested to be correlated to vitamin D status. Therefore, in the current pilot study, the potential of milk protein, prebiotics and vitamin D to support innate immune function in elderly will be investigated. Objective: Aim of the current study is to evaluate the effect of milk protein on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by prebiotics and Vitamin D will be studied. Study design: The study will be a double-blind placebo-controlled pilot study. Study population: Healthy female elderly subjects of 65-85 years of age. Intervention: Period 1: Milk protein or placebo. Period 2: Milk protein + prebiotics or placebo. Period 3: Milk protein + prebiotics + Vitamin D or placebo.
The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly prepared colons.
This study evaluates the ability of encapsulation of orally applied lipids in a yoghurt snack to modify ad libitum food intake and satiety, without GI symptoms. Every subject receives two treatments (active, and placebo) on two different days, following a randomized cross-over design.
Repetitive bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) reduces craving and seems to decrease relapse risk in addiction. However, little is known about the relapse rates in cocaine addiction after tDCS, despite the need for neurobiological treatments to reduce the high relapse rates in this population. The current study explores the effects of repetitive tDCS in a larger sample (N=60) of cocaine addicted patients on number of relapse days after three months. We expect that a decrease in relapse risk after tDCS is associated with cognitive control functioning. Therefore, risky decision making and inhibitory control will be measured before and after the interventions, and at three months follow-up. Ecological momentary assessment (EMA) will be used as a reliable measure for relapse, craving and mood.
Radiotherapy (combined with chemotherapy) is increasingly applied in the curative treatment of tumours located in the thoracic region (esophageal cancer, lung cancer, breast cancer, and (non) Hodgkin lymphoma). Accurate radiotherapy planning and delivery is essential for the treatment to be effective. However, this accuracy is compromised by tumour and organ motion. Radiotherapy treatment planning is typically performed on a planning-CT scan recorded several days prior to commencement of radiotherapy. Inter-fraction set up variations and organ motion during treatment can lead to differences between the calculated dose distribution on the planning-CT and the radiation dose actually received by the tumour and normal organs. Accurate assessment of these effects is essential to determine optimal margins in order to irradiate the tumour adequately while minimizing the dose to the organs at risk (OARs). In the near future, patients with esophageal cancer, lung cancer, breast cancer and (non) Hodgkin lymphoma are excellent candidates for proton beam therapy (PBT), which enables marked reductions of the radiation dose to the OARs and thus decreasing the risk of radiation induced cardiac and lung toxicity. However, for PBT using pencil beam scanning (PBS), knowledge of tumour and organ motion will be even more important. The potential major advantages of PBS for tumours in the thoracic region are challenged by the respiratory motion of the tumour, breast, esophagus, diaphragm, heart, stomach, and lungs. Setup errors and inter- and intra-fraction organ motion cause geometric displacement of the tumours and normal tissues, which can cause underdosage of the target volumes and overdosage of the organs at risk. Furthermore, it can result in changes in tissue densities in the beam path, which can alter the position of the Bragg peaks and lead to distorted dose distributions. If pencil beam scanning techniques are used to treat moving tumours, there is interplay between the dynamic pencil beam delivery and target motion. This phenomenon can cause additional deterioration of the delivered dose distribution, usually manifesting as significant local under and/or over dosage. It is therefore essential to incorporate motion-related uncertainties during treatment planning. The main objective of this study is to evaluate the impact of inter-fraction tumour and organ motion - while taking into account intra-fraction movements appropriately - on photon and proton radiotherapy treatment planning in order to yield robust intensity modulated photon and/or proton treatment plans. Objective: To evaluate the impact of inter-fraction tumour and organ geometrical dislocation for moving tumours on photon and proton radiotherapy treatment plans in order to create robust intensity modulated photon- and/or proton treatment plans. Study design: Pilot-study (80 patients). Study population: Patients with esophageal cancer (EC), (non) small cell lung cancer ((N)SCLC) stage III, breast cancer, or (non) Hodgkin lymphoma who will be treated with radiotherapy (with or without chemotherapy) with curative intent. Intervention (if applicable): Not applicable. Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of clinical target volume), dose to organs at risk (OARs), such as the heart (mean heart dose, MHD) and the lungs (mean lung dose, MLD). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat planning CT scans in treatment position without contrast agents in order to evaluate the impact of inter-fraction tumour and organ motion. Furthermore, additional CBCTs are collected after 10 radiotherapy fractions to assess the intra-fraction motion. The additional radiation dose of these 3-6 4D-CT's and 10 CBCTs is low (4-6 x 25-30mSv + 10 x 7mSv results in an effective dose < 250mSv) compared to the therapeutic radiation dose (40-60Gy). The risks are therefore negligible and the burden is low.
The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube). This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.
Radiotherapy (combined with chemotherapy) is commonly used in the curative treatment of pelvic tumours, such as in cervical, vulvar and anal cancer. In these patients, cure rates are high but may be associated with significant treatment-related toxicities, especially dermatologic, gastrointestinal, genitourinary and hematologic toxicity. Accurate treatment planning and dose delivery is essential for radiotherapy in order to be effective in terms of local tumour control and to reduce radiation-induced side effects. However, accuracy is challenged by tumour and organ motion from fraction to fraction (interfraction movements). At present, radiotherapy treatment planning is typically performed on one planning-CT scan which is performed before the start of the treatment. However, interfraction set up variations and organ motions can lead to differences between the calculated dose distribution on the planning-CT and the radiation dose actually received by the tumour and normal organs (actual given dose). Current photon radiotherapy of the pelvic area is relatively insensitive to these changes and margins from CTV to PTV ensures an adequate dose coverage of the tumour area. Despite newer techniques in photon therapy, like intensity modulated radiotherapy (IMRT), critical organs still receive a substantial amount of dose leading to clinically relevant acute and late side effects. With proton beam therapy, the amount of radiation dose to the organs at risk can be significantly reduced. For proton beam therapy (PBT) however, knowledge of tumour and organ motion will be more important. The major potential advantages of PBT for tumours in the pelvic area in terms of prevention of radiation-induced side effects are challenged by differences in bladder volume, rectal filling and air gaps especially in the small bowel, sigmoid and rectum. Setup errors and organ motion cause geometric displacement of the tumours and normal tissues, which deteriorates the dose gradients from target volume to normal tissue. Furthermore, it can result in changes in tissue densities in the beam path, which can alter the position of the Bragg peaks, in turn leading to distorted dose distributions, usually manifesting as significant local under and/or over dosage. In this study, the investigators want to evaluate the impact of inter and intrafractional tumour and organ motion on photon and proton radiotherapy treatment planning in order to create robust intensity modulated photon- and/or proton treatment plans (IMRT, IMPT) with the final aim to lower treatment related toxicity. Objective: To explore the extent of inter- and intrafraction anatomical changes of the tumour and surrounding normal tissues, throughout the full course of treatment, and to subsequently assess the impact of these changes on the nominal planned dose. This information is required to design robust treatment plans (photon and/or proton) that will ensure optimal local tumour control while reducing toxicity. Study design: Pilot-study (40 patients). Study population: Patients with cervical, vulvar or anal cancer, who are planned for radiotherapy (with or without chemotherapy) with curative intent. Intervention (if applicable): Not applicable. Main study parameters/endpoints: Robustness parameters (homogeneity index; coverage of clinical target volume), dose to organs at risk (OARs), such as the small bowel, rectum, bladder and bone marrow. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: During the radiotherapy treatment course, patients will undergo weekly repeat planning CT scans without contrast agents in order to evaluate the impact of intra and inter-fraction tumour and organ motion. The additional radiation dose of these 5 extra CT's is relatively low (5 x 8 mSv, plus 1 x 22 mSv for the 4D CT scan) in relation to the therapeutic radiation dose (50.4-85 Gy). The risks are therefore negligible and the burden is low.
The purpose of this study is to assess the efficacy of voclosporin compared with placebo in achieving renal response after 52 weeks of therapy in subjects with active lupus nephritis.
This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety syringe (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3 doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks including pre-screening visit, a screening visit and a 12-week treatment period which concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately 55 Subjects will be enrolled in the study.
The purpose of the study is to demonstrate the effect of Certolizumab Pegol (CZP) treatment on the reduction of Anterior Uveitis (AU) flares in subjects with active axial Spondyloarthritis (axSpA) and a documented history of AU.