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.
Background Many people with cancer face ongoing problems from their disease and treatments, like fatigue, reduced physical fitness, feeling anxious or down, and neuropathy. While exercise might help with these problems, most studies did not focus on tailoring exercise to address these specific complaints. Exercise programs under supervision (like with a trainer) seem to work better, but barriers for following such sessions are travel distance and time. Therefore, following an exercise program at home with a trainer guiding via video (live-remote) might be a good solution. But, it is unclear how effective this remote exercise program is for cancer patients. Goal of the study: The main goal of this study is to assess the effectiveness of a personalized, live-remote exercise intervention for cancer survivors on quality of life and the patients' main complaint. The four complaints tackled in this study are: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and 4) neuropathy. Design of the study In the LION study, 350 cancer patients will be randomly divided into the exercise group or control group. These patients all have at least one of these complaints: 1) fatigue, 2) reduced physical functioning, 3) anxiety and/or depressive symptoms, and/or 4) neuropathy. Patients cannot participate in the study if they are already very active. The exercise group will start a 12-week exercise program right away, and the other group will wait for 12 weeks before starting. The exercise program consists of three sessions per week. Two sessions per week include aerobic training and strength training. These sessions will be followed by all patients; and aim to improve fitness and strength. The third session specifically aims at improvement of the main complaint, for example fatigue. Participants will get an app and a fitness tracker to help them stay on track with their exercises. Furthermore, patients get information on the effects of exercise for cancer patients and why exercise is important for specific complaints. Measurements The main outcomes of this study are quality of life and the main side-effect of the patient. Other measurements include all kind of patient reported outcomes (like sleep problems and pain), physical fitness, muscle strength, balance, anthropometrics, and (inflammatory) markers in blood. Conclusion: This study investigates if personalized exercises done at home, with video guidance, can make cancer survivors feel better and manage their side effects more effectively.
Advances in prenatal and neonatal care have improved outcomes in children with severe congenital heart disease (CHD). With the increase in survival, neurocognitive problems such as executive functioning (EF) impairments have become more apparent in these children. EF problems have cascading negative effects on a child's development. New insights in EF development suggest that in otherwise physically healthy young children, EF can be improved by training. In a pilot study funded by Stichting Hartekind, the investigators studied the feasibility of a personalized EF training program called 'Kleuter Extra' and the results were promising. Therefore, the current study will investigate the effectiveness of this program in 4-6-year-old children with severe CHD. The researchers will also explore interactions between the parent-child relationship and EF development of the child as psychosocial difficulties in these children and their parent(s) and/or caretaker(s) may impact EF-development. If found effective, EF training for children with severe CHD will improve their developmental outcome.
The goal of this clinical try is to investigate the effect of hyperbaric oxygen therapy (HBOT) on symptoms, quality of life and absence of work through sickness in patients with post-COVID on short- and mid-term, as well as to identify biochemical mechanisms of action. The main questions it aims to answer are: - What is the clinical relevance of improvements of symptoms and quality of life after treatment with HBOT for post-COVID? - What are the changes in absence from work after treatment with HBOT? - What is the cost-effectiveness of treatment with HBOT? - What are possible mechanisms of action of HBOT? Participants will undergo 40 sessions of HBOT. Researchers will compare HBOT with standard care alone (control group). In case of a positive outcome, patients in the control group can cross-over to the HBOT group after 6 months.
The purpose of this study is to assess wether the SONDA visual field test is suitable for patients with a supra sellar tumour.
Rationale: Every year, about 40,000 people in the Netherlands have a stroke. After the initial admission to the hospital, about 15% of stroke survivors is admitted to a rehabilitation center because of remaining disabilities. Three out of four of these patients have upper limb dysfunction, hampering activities of daily living. Upper limb function plays a critical role in the performance of most daily life activities. In our phase II trial B-STARS, continuous theta burst stimulation (cTBS) treatment led to an absolute additional recovery of upper limb function of 17%, as measured with the Action Research Arm Test (ARAT) score three months after stroke. This improvement exceeds the minimal clinically important difference of 10%. cTBS treatment also resulted in a significant improvement in measures of activities and participation (of similar magnitude) and a reduction in the mean length of stay at the rehabilitation center by 18 days. Objective: To assess the effectiveness and cost effectiveness of cTBS treatment in promoting upper limb recovery after stroke in patients admitted to a rehabilitation center. Study design: A phase III, multi-center, double-blind, randomized, sham-controlled, clinical trial. Study population: 454 patients aged 18 years or older with a first-ever ischemic stroke or intracerebral hemorrhage and a unilateral arm paresis, defined by a Motricity Index between 9 and 99, in whom cTBS treatment can be started within 3 weeks after stroke onset. Intervention: 10 daily sessions of cTBS delivered over the contralesional primary motor cortex during a period of 2 weeks, delivered immediately before regular care physical therapy of the affected upper limb. Main study parameters/endpoints: The primary endpoint will be the score on the upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days after stroke. Secondary endpoints will include the score on the FM-UE at one year and the scores on the Action Research Arm Test, Nine Hole Peg Test, Stroke Impact Scale, EuroQol 5 Dimensions and modified Rankin Scale at 90 days and one year after stroke
This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.
The goal of this exploratory randomized controlled trial is to assess the effect of a personalized training intervention during primary rehabilitation of 6 weeks on cardiorespiratory fitness in individuals with subacute (<6 months) spinal cord injury during primary rehabilitation and during follow-up. Secondary outcomes include the effect on gait assessments, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, quality of life, functional independence and self-efficacy. Participants in the intervention group will receive 2-3 personalized cardiorespiratory fitness-focused training sessions per week, for a period of 6 weeks. Participants in the control group will receive usual care.
The goal of this study is to evaluate the effectiveness of a programme for transitional palliative cancer care (Pal-Cycles) in seven countries (the Netherlands, Germany, United Kingdom, Hungary, Poland, Romania and Portugal) and its consequent effects on the number of readmissions into hospital. The main hypothesis for the study is: that fewer people in the intervention arm of the study will require hospital re admission than those having usual care. Participants will be asked to fill in questionnaires regarding their quality of care and quality of life.
Cataracts are a clouding of the lens of the eye. Cataract surgery replaces the cloudy lens with a clear artificial lens. It is one of the leading causes of low vision worldwide. Since cataracts are mostly age-related, the number of patients with cataracts is increasing sharply due to an ageing population. The indication for cataract surgery is currently based on the visual impairment experienced by the patient, a measurement of visual acuity and the ophthalmologist's assessment of the extent to which the clouding of the lens explains the patient's symptoms. It has been said that after cataract surgery, "the world opens up to you". However, about 10% of patients actually experience worse vision after surgery. This amounts to almost a whole month of potentially unnecessary surgery. It is therefore important to develop a more objective indicator for cataract surgery. Our study focuses on measuring the optical quality of the eye before and after cataract surgery. We also ask patients before and after cataract surgery how they themselves perceive the quality of their vision. We do this with different patient-reported outcomes. We investigate whether the objective measurement of the optical quality of the eye can predict which patients will be satisfied with the cataract surgery. With this, we aim to further improve patient care and prevent unnecessary surgery.
The ORBIT trial is part of a worldwide search for a functional cure of HIV. One such cure strategy aims to reverse HIV in the reservoir from latency by increasing cell-associated HIV-RNA, which will lead to increased antigen presentation, trigger immune recognition, and facilitate the elimination of reservoir cells (so-called 'shock and kill' approach to HIV cure). Participants of the trial are adults with HIV with undetectable viral load that are able to give informed consent to participate in the trial, in total 49 patients will be recruited. The investigational medical compounds in this trial are panobinostat, lenalidomide and pyrimethamine. These are all licensed drugs for other conditions. Participants of this trial will receive a single dose of the IMPs, either as monotherapy or as combination therapy. Sampling will be performed before, during and after medical treatment to evaluate latency reversal, reservoir reduction and safety endpoints. Patients will be recruited from the Erasmus MC, Amsterdam university Medical Center and the University Medical Center Utrecht.