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 primary goal of this observational study is to explore to which extent lithium concentrations in the brains in BD subjects correlate with clinical treatment response. Secondary, to determine correlations of brain lithium concentrations with serum lithium levels. Participants will undergo lithium magnetic resonance spectroscopy imaging (MRSI) within two weeks of reaching adequate serum lithium level. A blood sample will be drawn to determine lithium serum level and after one year a validated questionnaire will be used to assess clinical lithium response. Participants start with lithium treatment as part of their regular treatment.
Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.
The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that sacituzumab tirumotecan is superior to TPC with respect to OS.
SELENON-related myopathy (SELENON-RM) and LAMA2-related muscular dystrophy (LAMA2-MD) are congenital neuromuscular disorders presenting with slowly, progressive axial muscle weakness, spinal rigidity, scoliosis and respiratory insufficiency. Currently, no curative treatment options exist, yet promising preclinical trials are ongoing. Clinical trials are expected to start within 5 years. Natural history data and outcome measures for measuring therapy effectiveness were lacking. Therefore, the LAST STRONG Study (a 1.5-year natural history study) started in 2020. With the extended LAST STRONG Study, we aim to further analyze and expand the 1.5-year natural history data on SELENON-RM or LAMA2-MD to provide a detailed clinical description of the Dutch and Flemish cohort. This will enable a smooth transition towards implementation into clinical care and clinical trials. The extended LAST STRONG Study is a prospective, observational natural history study in Dutch-speaking patients of all ages diagnosed with SELENON-RM and LAMA2-MD. Patients will be invited to visit our hospital two times (3- and 5-years) after the first visit in the LAST STRONG Study. During both visits, patients will undergo a subset of tests (neurological examination, functional measurements, questionnaires, muscle ultrasound, MRI, pulmonary assessment and accelerometry). All measurements are adapted to the patient's age and functional disabilities.
Sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. Music interventions have shown potential in improving sleep quality. Unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. Therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. Participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. The researchers will compare both groups to see if there is a difference in sleep quality.
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumours with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.
This study prospectively evaluates the effect of surgical wait time on knee function, pain and quality of life in patients waiting for knee arthroplasty (TKA or PKA)
The goal of this two-armed randomized controlled trial is to investigate the effectiveness of a new, individually tailored, brief behavioral training for teachers of children with behavioral difficulties at school. The main questions the study aims to answer are: - Does the brief teacher training reduce the severity of four daily rated target behaviors in specific classroom situations compared to practice as usual (PAU) on the short term? - Does the brief teacher training program reduce the severity of the same four daily rated target behaviors in other classroom situations, behavioral difficulties of the child at school and at home, and the impairment of the child in the school situation and reduce the number of behavioral difficulties of the child at school judged as troublesome by the teacher, and improve the teacher-student relationship quality, teachers' sense of efficacy, and teachers' behavior management strategies compared to practice as usual (PAU) on the short term? - Are short-term improvements maintained at 3 months follow-up? Teachers will be randomly assigned (simple randomization) to (a) three sessions of brief teacher training with PAU, or (b) PAU only. The brief teacher training provides teachers with individually tailored stimulus control and contingency management techniques to treat children's behavioral difficulties in two (bi)weekly training sessions of two hours and a third session of one hour in which the training will be evaluated and maintenance training will be provided. PAU may include any support or treatment as regularly provided by mental health care centers, schools, school collaborations and/or other organizations, except from pharmacological treatment for children's behavioral difficulties and/or behavioral teacher training/support. PAU can also imply that there is no support or treatment.
The 3TR-ABC study is a multicentre observational prospective cohort study platform that follows patients with severe asthma from the start of biological therapy and three years onwards. In the 3TR-ABC platform, individual studies are conducted on specific biologics, using aligned study designs. The aim of the study is to assess response to treatment and examine clinical characteristics, biomarkers, and immunological mechanisms related to response, including remission and non-response, that might be new targets or explanations for insufficient treatment. Patients will be extensively characterized at baseline and then followed throughout the years with formal clinical and biological assessment at 4, 16, 52 weeks, and 2, 3 years. Based on the response to treatment, patients will be stratified into remission, clinical responders, and non-responders, and pre-treatment biomarker profiles obtained at the baseline visit will be compared, as well as the immunological response to treatment. Healthy individuals and patients with mild/moderate controlled asthma are included as reference groups and will undergo the same baseline visit as patients with severe asthma. Several bio-samples, to perform multi-omic analysis, will be taken to examine biological pathways associated with response and non-response to biologics.
This study is a multicenter, prospective, randomized controlled trial (RCT) to compare the effectiveness of a smartphone-based self-monitoring and self-management tool on control self-efficacy with respect to standard clinical practice for patients with relapsing-remitting multiple sclerosis (RRMS). RRMS patients will be recruited and screened for study eligibility at four Dutch MS centers. Following inclusion, participants will be randomly allocated to the intervention group (use of MS sherpa® in addition to standard care) or control group (standard care only). The duration of follow-up is 12 months with study visits at baseline and 12 months, and additional study assessments coupled with every clinical visit as part of standard care during the follow-up period.