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.
This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.
The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.
The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain. Secondary endpoints are to assess pain scores, side-effects, quality of life, depressive symptoms and pain coping.
Background of the study: Protein intake is often higher than recommended in Western countries. This leads to increased amounts of protein flowing into the large intestine. Next to increased dietary protein intake, protein digestibility, and endogenous protein losses also affect the amount of protein entering the large intestine. However, these aspects have barely been studied, especially in humans. The large intestine is home to the largest bacterial ecosystem of the body. During the fermentation of protein by these bacteria (microbiota), metabolites are produced such as ammonia, branched-chain fatty acids, biogenic amines, phenolic compounds, indoles, and N-nitroso compounds. There is evidence that some of these metabolites could be harmful for gut epithelia, gastrointestinal health, and health in general after they enter blood circulation. In general, doing measurements inside the gastrointestinal tract is invasive. During this project the protein fermentation will be studied in the gastrointestinal tract using feces and urine, but also in situ using the GISMO GEN1 ingestible. This ingestible contains sensors to measure pH, ammonium, temperature, and redox potential. Objective of the study: The primary objectives of this study are: 1. To investigate the feasibility of the GISMO GEN1 System to monitor biomarkers in the gastrointestinal tract by studying the ingestible transit time, data coverage, participant experience, and serious adverse events (if applicable). 2. To study the effect of a 7-day high versus low digestible protein source present in the diet on protein fermentation in healthy subjects, measured by ammonia concentrations. Study design: The study is divided into 2 phases. In phase 1, preliminary feasibility of the GISMO GEN1 ingestible system will be assessed and the baseline measurements will be taken without any dietary restrictions. An interim analysis will be performed after phase 1 and only after a positive evaluation of the GISMO GEN1 System, the study will continue with phase 2. Phase 2 is a randomized cross-over controlled feeding trial. Two diets will be used: one diet containing a high digestible protein source, and the other diet containing a low digestible protein source. Each diet will be given for 7 days, with a wash-out period in between. Measurements done during the dietary interventions will be compared to the other diet, and to the baseline measurements. Study population: 15 healthy male or female volunteers, age 16 or older, BMI 18.5-30. Intervention: A high digestible protein diet (30 g/d whey protein) and a low digestible protein diet (30 g/d bovine plasma protein). Primary study parameters/outcome of the study: Ammonia as biomarker for protein fermentation, measured in feces and urine and in situ by the GISMO GEN1 ingestible. Also, ingestible transit time, data coverage, participant experience, and serious adverse events. Secundary study parameters/outcome of the study (if applicable): Secondary study parameters include other protein fermentation related metabolites measured in feces, urine and blood; microbiome composition; transit time; absorption kinetics.
Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. In these cases, especially if a CT-scan shows opacification of the mastoid air cells, a mastoidectomy can be considered as treatment modality. In recent years, obliteration of the mastoid cavity following mastoidectomy is gaining popularity. However, the effectiveness of obliterating the mastoid in comparison to mastoidectomy alone is uncertain for CSOM. In this retrospective cohort study, our aim is to compare mastoidectomy to mastoidectomy + mastoid obliteration in a cohort of patients suffering from CSOM with mastoid involvement. The hypothesis is that obliterating the mastoid cavity will result in a higher frequency of dry ears and in a lower frequency of revision surgeries.
In recent years, mastoid obliteration (MO) after mastoidectomy has gained popularity. However, the choice for obliteration material has been a point of discussion. Autologous materials have the advantage of being freely available without cost.Synthetic materials on the other hand have unlimited supply, hold volume over time and have no risk of donor site morbidity. Comparative studies between materials are rare and the few available were unable to ascertain superiority. Our hospital has been utilizing the same material for obliteration since 2011: S53P4 bioactive glass (BAG). It since has become our main operating procedure to obliterate the mastoid cavity with BAG granules following both canal wall up (CWU) and canal wall down (CWD) mastoidectomy. This bioactive glass has several important characteristics, such as the retaining of volume over time and antibacterial properties. An important factor when selecting obliteration material is safety. Data on this was reported in several studies, but unfortunately these studies only investigated short-term safety in small and selected cohorts of patients, often without comparison. Additionally, large studies with extensive follow-up are necessary to detect rare complications and long-term pitfalls. Therefore, the aim of this study is to determine the safety of BAG in a cohort that encompasses all cases that underwent CWU+MO and CWD+MO in our institute and compare these results to a non-obliteration cohort. The main outcomes are short- and long-term safety, as indicated by surgical complications in the first year following surgery and revision surgeries during follow-up, respectively. We compare the obliteration cohort to the non-obliteration cohort, hypothesizing that obliteration results in a comparable or lower rate of complications and revision surgeries
The goal of this two-armed randomized controlled trial is to investigate the effectiveness of a new, individually tailored, brief behavioral training for parents of children with behavioral difficulties in general practitioners' practices. The main questions the study aims to examine are: 1. The short-term effectiveness of a brief and individually-tailored, behavioral parent training program in primary care settings on the severity of four daily rated target behaviors in specific home situations, compared to care as usual (CAU). 2. The short-term effectiveness of the brief parent training compared to CAU on secondary outcome measures: severity of the same four daily rated target behaviors in other home situations, severity of child disruptive behaviors, number of child disruptive behaviors perceived as troublesome by the parents, overall impairment of child behavioral difficulties, impact of child behavioral difficulties on the relationship with parents, parenting behaviors, parenting stress and parenting self-efficacy. 3. The longer-term outcomes (three month follow-up) of the brief parent training program on primary and secondary outcomes. 4. The satisfaction and acceptability of the brief parent training program in primary care settings as perceived by parents and child mental health workers. Parents will be randomly assigned (simple and parallel randomization) to (a) the intervention condition in which parents receive three sessions of brief parent training and may receive CAU, or (b) the control condition in which parents may receive CAU. The brief parent training provides parents 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. CAU may include any support or treatment as regularly provided by general practices, mental health care centers, schools and/or other organizations, except from pharmacological treatment for children's behavioral difficulties and/or behavioral parent training/support. CAU may also imply that there is no support or treatment. After the first posttreatment assessment (T1) parents in the control condition will be offered the brief parent training as well.
A planned analysis of outcomes among consecutive patients after MIDP from centers participating in the E-MIPS registry (2019-2021). Main outcomes of interest were intraoperative events, major morbidity (Clavien-Dindo grade ≥3) and 30-day/in-hospital mortality.
Post-Covid syndrome, also known as long Covid, is a clinical condition in which patients experience long term symptoms after Covid-19 infection. Treatment options for post-Covid are not effective. Therefore, there is an urgent need for a novel therapy. The first study results of HBOT in post-Covid patients are promising. Previous research from Israel has shown improvements in quality of life after HBOT. However, long term results are unknown. Therefore, this study aims to evaluate quality of life at one year after hyperbaric oxygen therapy in post-Covid patients with cognitive symptoms. It is hypothesized that quality of life at one year after HBOT is improved. Furthermore, this study aims to evaluate return to work after HBOT. To our knowledge this was not done before. An observational prospective cohort study will be conducted to answer the research questions. All post-Covid patients who are treated with hyperbaric oxygen therapy in participating centers, will be eligible for inclusion. Questionnaires and medical doctor consultations will be used in order to collect all data. There are no risks for participants, since only 7 questionnaires are not part of standard clinical care. The burden is approximately 40 minutes extra in total for participants, compared to standard clinical care.
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.