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.
Parkinson's disease (PD) is a neurodegenerative disorder that is characterized with motor symptoms such as hypokinesia, rigidity, tremor and postural instability. These symptoms can also be present during the night. Half of the patients with PD have difficulty turning around in bed. This nocturnal hypokinesia is considered as a possible cause of sleep problems in this population. The diagnosis nocturnal hypokinesia is based on the clinical interview. There is a need for a diagnostic devices that measures nocturnal movements, preferably in the home setting. This device can be used in the diagnostic trajectory as well in the evaluation of treatment. Recently the Dynaport Minimod (McRoberts, The Hague) has been developed to register nocturnal movements. The tri-axial accelerometer has been developed to measure position changes in the night. A validation study with actigraphy and polysomnography concluded that the Dynaport MiniMod is a valid an feasible device for assessing intensity and physical activity and changes of body position during sleep. Nocturnal hypokinesia is treated with nocturnal dopamine. Sometimes a night-time dose of dopaminergics is adequate, but most of the time slow release dopaminergics are needed. However response fluctuations can negatively influence the treatment. In these cases continuous dopaminergic stimulation is needed, such as rotigotine. Rotigotine treats response fluctuations during the day and studies show that sleep quality measured with questionnaires improves. If the improvement of sleep quality is caused by improved bed mobility has not been studied yet. The study hypothesis is that rotigotine does not influence nocturnal hypokinesia in PD. Objective of the study: Primary: • To study the effect of rotigotine on nocturnal hypokinesia Secondary: - To study the possibility of measuring nocturnal hypokinesia and its severity in a home setting - To correlate improvements in sleep quality by rotigotine with changes in nocturnal hypokinesia Study design: We will study patients who will recieve rotigotine as a part of their usual care. During three nights, nocturnal movements are being registered with movement sensors, before treatment has started as well as after a stable medication dose of one month. We will also assess sleep quality with questionnaires. Study population: The study population are patients with Parkinson's disease with sleep problems caused by nocturnal hypokinesia, who will start treatment with rotigotine. Patients will be recruited in the neurology patient outdoor clinic of the Radboud University Medical Centre Nijmegen. We will ask the treating neurologist to inform us when a patient will start treatment with rotigotine. One of the researchers will contact the patient to give further information about the study. The study is a first hypothesis generating study and we will start with the inclusion of 10 patients. Intervention (if applicable): Primary study parameters/outcome of the study: Position changes over the night. Secundary study parameters/outcome of the study (if applicable): Objective - Degree of mobility, measured as the speed of the movements - Total amount of movements - Score on the motor symptom scale according to the MDS-UPDRS part III Subjective - Nocturnal sleep quality Excessive daytime sleepiness - Presence of nocturnal akinesia
It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus. Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will accumulate, because of an improved balance between supply and demand of lipids. The major research objective is to examine if acute exercise results in a more pronounced increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in endurance-trained subjects when compared to sedentary subjects. The investigators hypothesize that the increase in acetylcarnitine levels will be lower in trained subjects when compared to sedentary subjects, due to a better balance between lipid supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine concentrations will be restored faster in these trained subjects, because of a tighter regulation of influx of fatty acids. To test this hypothesis the investigators want to compare the acetylcarnitine response to exercise in a group of sedentary subjects and a group of endurance trained subjects. This response will be measured for 30 minutes after exercise with the use of 1H-MRS.
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
This is a 12 week open label pilot study to determine the efficacy and safety of a surgically implanted, electrically active vagal nerve stimulation device in patients with active rheumatoid arthritis.
This will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis. Patients who complete study SPM-005 will be enrolled in this study at the time of the last visit of the preceding study.
Abdominal pain resulting from chronic pancreatitis (CP) is often recurrent, intense and long-lasting, and is extremely difficult to treat. Medical analgesic therapy is considered as first choice in pain management of CP, resulting in regularly prescription of opioids. The adverse consequences of prolonged opioid use, including addiction, tolerance and opioid induced hyperalgesia, call for an alternative medical treatment. Cannabis has been used to treat pain for many centuries. Delta-9-tetrahydrocannabinol (Δ9-THC), the psychoactive substance of the cannabis plant, has been shown in previous studies to be a promising analgesic. The development of Namisol®, a tablet containing purified Δ9-THC showing an improved pharmacokinetic profile, provides the opportunity to test the analgesic potential of Δ9-THC in favourable conditions. The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of abdominal pain resulting from CP.
The purpose of this study is to determine energy expenditure and sleep in response to protein/carbohydrate and fat ratio of the diet over a short-term and long-term period of time.
This study will be executed according to a randomized double-blind placebo-controlled trial with two parallel groups, treated over the period of 6 months with escitalopram or placebo. Hypotheses: Escitalopram is more effective than placebo in the control of gastrointestinal symptoms, in irritable bowel syndrome (IBS) patients with panic disorder. Escitalopram is more effective than placebo in the control of psychiatric symptoms, in IBS patients with panic disorder.
This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.
The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring results in an earlier detection of circulatory failure in newborn infants