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.
The purpose of this study is to compare STZ vs everolimus as first line treatment for advanced pNET and to elucidate which sequence of streptozotocin (STZ) based chemotherapy and the mammalian Target of Rapamycin (mTOR) inhibitor, everolimus, gives better results in terms of second Progression Free Survival (PFS) in well differentiated and advanced pancreatic NETs.
The primary objective is to investigate the efficacy of resveratrol on mitochondrial function in patients with COPD. The secondary objective is to investigate the effect of resveratrol on body composition, inflammatory status and mechanistic markers in blood, adipose and muscle tissue as well as a comprehensive assessment of metabolicand physical performance profile known to be affected by resveratrol.
Up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this disability is mild to moderate (WPN3-). Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary rehabilitation settings but might also benefit from treatments based on these multidisciplinary rehabilitation treatment principles when provided by specifically trained primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the feasibility of a specifically for primary care physiotherapist developed biopsychosocial intervention ("Back on Track" intervention) in WPN3- classified patients, and to evaluate whether this "Back on Track" intervention results in a significant improvement in functional disability in this subgroup of patients.
Dairy-based beverages contain fat and sugars. As both contribute to the energy intake upon consumption, food industry strives to reduce these ingredients while maintaining the taste, texture and aroma properties of the beverages. A successful reduction of fat and sugar from drinks has still proven a great challenge since consumers have less preference for the mouth feel of reformulated beverages than for the regular beverages. Mainly because instrumental measures like rheology and traditional tribology do not entirely predict the experienced mouth feel, there is an interest in alternative correlates for mouth feel aspects related to fat and sugar perception. In a recent study it was demonstrated that vibrations produced during interaction between the tongue, palate and beverages during consumption are very sensitive to the amount of fat and texturizers in the beverage. The present study aims at clarifying that relation for a larger panel of human subjects, by systematically evaluating vibration spectra during consumption of dairy beverages that differ in fat content, sugar content or pH. Secondly, the correlation of vibration spectra (acoustic tribology) with mouth feel-related sensory properties and composition of fat deposits on the tongue will be assessed.
Exercise intolerance, muscle weakness and fatigue complaints are frequent and persistent problems in sarcoidosis. These physical impairments are disabling and affect quality of life in a negative way. The aetiology of these physical impairments is multifactorial. Physical inactivity can cause deconditioning, resulting in more perceived fatigue and muscle weakness. These symptoms may be partially reversible following a structured physical training program. However, scientific studies about physical training in sarcoidosis are lacking. Therefore, the aim of the present study is to examine the changes in fatigue complaints, physical functioning and quality of life (QOL) in patients with sarcoidosis following a 13-week physical training program. After obtaining written informed consent, sarcoidosis patients will start a 13-week physical training program for three times a week. This training program includes peripheral muscle training for both the upper and lower extremities (starting at 40% of the multiple-repetition maximum) and endurance training consisting of walking on a treadmill (starting at 60% of the speed of the 6-minute walk test) or cycling on a ergometer (starting at 50% of the Wmax). Participants will be assessed at baseline (week 0), at the end (13 weeks) and 3 months after ending the training. During these assessments, patients perform muscle strength (m. quadriceps and m. biceps) and exercise tests (six-minute walk test and submaximal endurance cycling test). They also complete several questionnaires: Fatigue Assessment Scale (FAS), World Health Organization Quality of Life assessment instrument-BREF (WHOQOL-BREF), Small Fiber Neuropathy Screening List (SFNSL), Medical Research Council (MRC), Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale (HADS)
Rationale: Increased intakes of n-3 long chain polyunsaturated fatty acids eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA), mainly found in fatty fish, are recommended for the prevention of coronary heart disease. Alpha-linolenic acid (ALA, C18:3n-3) is the most common vegetable-oil based n-3 fatty acid. Evidence exists that ALA supplementation can also have a protective effect on the development on cardiovascular disease, but may exert its cardio protective effects through different routes. The benefit may (partly) be due to blood pressure lowering. However, evidence for beneficial effects of ALA on blood pressure is conflicting. Therefore, we propose to investigate the effect of flaxseed oil, high in ALA, using a study powered on 24-hour blood pressure, in a population with high normal blood pressure and mild hypertension. Objective: To study the effects of flaxseed oil, rich in ALA on 24h-ambulatory mean arterial pressure (MAP) in men and women with high-normal blood pressure and mild hypertension compared to high oleic sunflower oil, poor in ALA. Study design: Using a double blind randomized, placebo-controlled parallel design, subjects will receive at random daily 10 g of flaxseed oil or a high-oleic acid sunflower oil (HOSF) as control for twelve weeks, with a run-in period of 14 days in advance. Study population: 72 men and women, aged 40-70 years, with untreated high-normal blood pressure and stage I hypertension and a body mass index between 25 and 35 kg/m2 will participate in the run-in and intervention period. It is estimated that 144 subject have to be screened to find 72 subjects that will enter the run-in period. Intervention: During the run-in period, subjects will receive daily 10 g of palm super olein oil. During the intervention period subjects receive either 10 g of HOSF or flaxseed oil. All oils are provided in bottles of 5 g, one will be consumed at breakfast or lunch and one at dinner. Main study parameters/endpoints: The main study parameter is the change in 24h-ambulatory mean arterial pressure (MAP)
The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body. In addition, the effects of age and gender are investigated. The study consists of two parts. In Part 1 four dose levels are administered to four separate groups initially. Two additional dosages are then investigated. Subjects receive either a once-daily dose (QD) or twice-daily dose (BID) of ASP3652 or placebo. Part 2 is performed in one group of elderly healthy male or female (post-menopausal) subjects. Subjects receive either a twice daily dose (BID) of ASP3652 or placebo. For both parts of the study, the subjects stay in the clinic for one period of 18 days.
This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.
Given that the cost of proton therapy is considerably higher than that of conventional radiotherapy with photons, it is necessary to establish whether these higher costs are worthwhile in light of the expected advantages2,3,4. Thus, clear evidence of the situations in which proton therapy outperforms conventional photon treatment is needed. The investigators therefore aim to demonstrate through an in silico trial that proton therapy decrease the amount of irradiated normal tissue and, consequently, the risk of side effects in the surrounding normal tissue as well as the risk of secondary tumors. The same overall treatment time and an equal number of fractions will be used for both treatment modalities wherever possible. The most optimal technique for each individual patient, based on objective criteria related to limiting dose to normal tissue, will be prescribed by the institution concerned for each treatment option.
The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included. All directions for medication usage and patient monitoring are solely at the discretion of the investigator in accordance with their usual practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg VDS. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during induction of labour. No effort is expected from the study subjects. 150 patients from 20 Dutch centres will be included.