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.
Invasive aspergillosis (IA) is the most common mould infection in immunocompromised patients with haematological disease. Voriconazole, a triazole, improves overall survival of patients with an IA and is the mainstay of therapy. Resistance of A. Fumigatus emerged as an important clinical problem and infections with azole resistant Aspergillus have a high mortality. Nowhere in the world, azole resistance is more prevalent than in the Netherlands. Rapid detection of resistance is key to improve the patient's outcome but fungal cultures take time and are often negative. The investigators aim to detect azole resistance associated mutations in fungal DNA extracted directly from serum or plasma to accelerate diagnosis and improve outcome of patients infected with azole resistant A. fumigatus.
RESEARCH QUESTION Is the effectiveness of conservative policy comparable to that of surgery in children with trigonocephaly, with regard to clinical outcomes and psychosocial functioning, stress for parents, and costs? DESIGN Observational cohort study in children, aged 0 to 8 years old, with trigonocephaly, excluding metopic ridging (physiologic early closure of metopic suture), treated conservatively or surgically. OUTCOME MEASURES Primary: Head growth decline, indicating raised intracranial pressure Secondary: fundoscopy, cognition, behavior, refraction and vision, forehead shape, quality of life, posttraumatic stress, decisional conflict, costs.
The goal of this randomized controlled trial is to compare the effectiveness of two innovative interventions aimed at preventing cognitive decline and work-related problems to enhanced usual care in improving quality of life in people with multiple sclerosis. Secondary objectives are: - to compare the effectiveness of the investigated interventions in improving cognitive, psychological, and work functioning, and in enhancing the brain's functional network - to examine which factors (i.e., baseline cognitive, psychological, work, and brain MRI-parameters) are predictive of the response to the investigated interventions - aim to qualitatively reflect on the process and outcome of the investigated interventions considering the perspectives of relevant stakeholders to allow for smooth and successful implementation in clinical practice Participants will follow the intervention for four months, with follow-up measurements at six months after intervention and 12 months after intervention.
This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
Rationale: Incisional hernias (IH) are a frequent complication after abdominal surgery. Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70% in high-risk patients after open surgery. To investigate different fascia closure techniques in the prevention of IHs, the STITCH trial (NCT01132209) was designed. The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy. Patients were randomly assigned to the intervention group (small bites 5 mm x 5 mm) or the control group (large bites 1 cm x 1 cm). The study showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision. So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group. Objective: The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.
The primary objective of the study is to evaluate the safety and tolerability of single doses (Part A) and multiple doses (Part B) of AP31969 in healthy participants.
The goal of this clinical trial is to investigate if access to the StoMakker application will significantly improve health-related quality of life in children receiving surgery resulting in an ileostomy, colostomy or continent urostomy. The main question it aims to answer are: - Does access to StoMakker improve health-related quality of life in children receiving surgery for an ostomy? - Does access to StoMakker improve the anxiety and social functioning of children receiving surgery for an ostomy? - Does access to StoMakker improve postoperative complications of children receiving surgery for an ostomy? Participants will be asked to fill in several questionnaires around their surgery. The intervention group of the trial will be given access to the application "StoMakker". The control group of the trial will receive standard care.
Peritoneal dialysis (PD) is the most frequent modality of home dialysis for patients with kidney failure. Most PD catheters are placed using a laparoscopic technique. This approach requires the availability of a qualified surgeon, time in the operating theater and general anaesthesia for the patient. Thus, the laparoscopic technique is less suitable for patients with severe heart failure or multimorbidity where general anaesthesia is not possible. PD catheters can also be inserted using a percutaneous strategy using a modified Seldinger technique. This strategy can be performed bedside under local anaesthesia, by the nephrologist, radiologist, a surgeon, physician assistant or qualified nurse. The availability of the percutaneous implantation strategy of a PD catheter in a nephrology center may accomodate more patients to receive a PD catheter insertion, including those who have a contraindication to general anaesthesia or need urgent PD. The PREDICT project aims to increase knowledge and competencies on percutaneous PD catheter insertions by training centers for this technique. By establisching a prospective registry, the outcomes of percutaneously inserted PD catheters, both in experienced and newly trained centers, will be assessed.
The goal of this study is to evaluate the effectiveness of an individualized treatment trajectory in which the order of trauma therapy for the parent (Eye movement desensitization and reprocessing (EMDR) therapy), trauma therapy for the child (EMDR therapy) and attachment-based therapy (Dutch short-term intervention for atypical parenting behavior (NIKA)) is tailored towards the complex needs of victimized parents and their young children (4-6 y/o) after domestic violence. The treatment trajectory is based on a guidance document that supports therapists to determine the optimal order of interventions based on a standardized set of factors. The primary goals of this study are: 1. To examine how post-traumatic stress disorder (PTSD)-symptoms of parent and child and parental sensitive and disruptive parenting behavior develop and interact over time, while they follow the individualized treatment trajectory. 2. To test whether the start of the treatment trajectory (e.g. the phase in which parents can receive NIKA and EMDR therapy and their child can receive EMDR therapy) leads to a decrease in disruptive parenting behavior towards the child, an increase in sensitive parenting behavior towards the child, and a decrease in PTSD symptoms of the parent in comparison to the baseline phase. 3. To test whether the start of the treatment trajectory (e.g. the phase in which children can receive EMDR therapy and their parent can receive NIKA and EMDR therapy) leads to a decrease in PTSD symptoms of the child in comparison to the baseline phase.
The goal of this clinical study is to learn about an investigational gene therapy product called AVB-101, which is designed to treat a disease called Frontotemporal Dementia with Progranulin Mutations (FTD-GRN). FTD-GRN is an early-onset form of dementia, a progressive brain disorder that affects behavior, language and movement. These symptoms result from below normal levels of a protein called progranulin (PGRN) in the brain, which leads to the death of nerve cells (neurons), affecting the brain's ability to function. The main questions that the study aims to answer are: 1. Is a one-time treatment with AVB-101 safe for patients with FTD-GRN? 2. Does a one-time treatment with AVB-101 restore PGRN levels to at least normal levels? 3. Could AVB-101 work as a treatment to slow down or stop progression of FTD-GRN? In this study there is no placebo (a dummy pill or treatment used for comparison purposes), so all participants will receive a one-time treatment of AVB-101 delivered directly to the brain, with follow-up assessments for 5 years.