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 study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.
In this study, various health care professionals will follow an E-learning module in which BCC detection on OCT is explained. Thereafter, the participants will test their skill by assessing OCT-scans. Their performance will be monitored using cumulative-sum analysis. After completion, newly trained OCT assessors will test their diagnostic accuracy for BCC detection on OCT in a exploratory study. The trainability, amount of required training and diagnostic accuracy will be compared between dermatologist and non-dermatologists.
In this pilot study the effect and safety of the use of steroid eye drops in chronic central serous chorioretinopathy (cCSC) will be evaluated. The study is conducted as a randomized single-blind placebo-controlled trial. Forty patients will be randomized to either steroid eye drops or placebo eye drops. Patients will self-administer the eye drops three times a day for four weeks.
Orthopaedic surgeons are often faced with the clinical dilemma of whether or not to add fusion to a decompression procedure. To decide between these two surgical options, surgeons rely mostly on their experience to conclude if a level is unstable preoperatively or if a specific decompression procedure is likely to destabilize the spine. Recently, the Sagittal Plain Shear Index (SPSI) has been developed as a valid test for determining the degree of spinal (in)stability. The SPSI metric, which can be calculated using flexion-extension radiographs of the lumbar spine, informs the orthopaedic surgeon about whether the spine is stable in and of itself (necessitating decompression surgery only) or whether there is spinal instability (necessitating decompression and additional fusion surgery). The SPSI metric can be calculated using both the validated semi-automated QMA® and more recently developed fully automated Spine CAMP software platforms. The concurrent validity between these two software platforms, as well as the reliability of both of these objective diagnostic indicator for spinal instability have not yet been evaluated. This study will investigate if SPSI-metrics/values obtained with Spine CAMP are equivalent to measurements from QMA®, and will also investigate the repeatability of two measurements of the SPSI taken one hour apart ('test-retest reliability').
The primary objective of this study is to determine the safety and tolerability of multiple doses of QRL-201 in people living with ALS
Research shows that online unguided self-help interventions focused on psycho-education, skills training and lifestyle can prevent mild mood complaints from turning into a full-blown depression. These encouraging results are found even though the adherence to these types of interventions is generally low. With this project, the investigators examine whether effectiveness and adherence to online unguided self-help interventions can be increased by additional motivational guidance elements. This is examined by adding three additional components to the intervention: 1) A coach who provides online feedback once a week to provide support. 2) Mobile application to monitor mood and related factors and to receive automated personalized messages, 3) Content based on the principles of motivational interviewing. A secondary aim is to compare the additional effects of the individual components against the additional costs.
The goal of this clinical trial is to study respiratory muscle training in patients with Spinal Muscular Atrophy (SMA). The main questions it aims to answer are: - Is a home-based individualized training program for the inspiratory and expiratory muscles feasible (good adherence and good acceptability)? - Can a home-based individualized training program for the inspiratory and expiratory muscles increase the strength of these muscles? Participants will be asked to perform 10 training sessions per week, spread out over 5-7 days. Each training session consists of 30 breathing cycles through the inspiratory muscle trainer and 30 breathing cycles trough the expiratory muscle trainer. In the first four months of the study researchers will compare two groups to see if a higher trainings load is more effective. One group will start at a trainings load of 10% of their maximal inspiratory and expiratory muscle strength. The other group will start at a trainings load of 30% of their maximal inspiratory and expiratory muscle strength. This group also need to adjust the trainings load based on their perceived exertion. After four months all participants will train on a trainings load of 30% of their maximal inspiratory and expiratory muscle strength and adjust the trainings load based on their perceived exertion. The participants will come to the hospital for lung function tests every four months for 12 months.
Rationale: Alcohol-Avoidance Training (AAT) has been used successfully to strengthen avoidance-tendencies in patients with alcohol use disorder (AUD). AAT is already recommended in German clinical treatment guidelines as an evidence-based treatment for AUD and may be incorporated in the next revision of the Dutch clinical guidelines on AUD. Studies in other fields (semantic learning) suggest that spaced learning may be superior to massed learning, but this has not been studied with regard to AAT. Objectives: To compare the effectiveness of spaced versus massed AAT sessions. Study design: a two armed, randomised controlled trail. All participants will receive AAT in addition to routine clinical care in an inpatient setting (Treatment As Usual; TAU). AAT sessions in the experimental group (AAT-S) will be spaced out over four weeks following detoxification. Sessions in the control group (AAT-M) are massed within one week following detoxification. Assessments of alcohol consumption and craving take place before the start of AAT (baseline: T0, timeframe: last 30 days before admission (alcohol use) or past week (craving)) at three (T1) and six months follow-up (T2). Study population: 200 patients with a primary DSM-5 diagnosis of AUD who receive TAU at three addiction care sites (clinical facilities 'Zevenaar', 'Tiel' and 'Wolfheze') of IrisZorg. Patients have finished alcohol detoxification, age ≥ 18, have good Dutch proficiency and have given written informed consent. During the follow-up assessments they are likely to have progressed to regular outpatient addiction treatment. Intervention: During their four week (minimum) admission all participants receive TAU, which includes Community Reinforcement Approach (CRA) (Meyers & Smith, 1995) grouptraining, AAT, sociotherapy and pharmacotherapy. AAT is a Cognitive Bias Modification paradigm that is used to retrain alcohol approach biases. In AAT participants must react to pictures of alcoholic and non-alcoholic beverages with a joystick to the tilt of the pictures which are presented on a computer screen. In current routine clinical care AAT sessions are massed in the first week after detoxification (control condition: AAT-M). In the experimental condition AAT trails will be spaced out over four weekly sessions instead of one week (AAT-S). Main study parameters/endpoints: Changes from baseline to three and six month follow-up in: 1. Mean daily units of alcohol consumed (past 30 days); at baseline this refers to the 30 days directly pre-admission). 2. Mean ratings of mean alcohol craving (past seven days). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants in both conditions will receive the same amount of AAT sessions and trials. Sessions in the AAT-S condition will be spread out over four weeks. Participants in this condition will therefore be exposed to AAT alcohol pictures over a longer period. Given our current experience of AAT as part of TAU, we expect little risk of participants experiencing more sensations of craving. Alcohol (use) is discussed daily during admission as part of TAU. As an extra burden, participants will be asked to complete a questionnaire before the first AAT session. Participants will be approached for follow-up assessment three and six months following the first month of inpatient treatment. Participants receive an incentive (a voucher worth €15,-) after completing all FU assessments, as a compensation for the extra burden.
The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.
Patellofemoral pain is a common complaint especially in young adults. It can be caused by patellar maltracking. Part of this is a patella alta. When patellar maltracking is the cause of the problem and conservative therapy fails, surgery, a tibial tuberosity transposition, may be considered. Most research has been done in patients with recurrent patella luxation. However, in patients without luxation, research is scarce. It is known that patients with patella alta have an increased risk of developing patellofemoral chondropathy due to increased pressure. With this study, we aim to investigate whether and how a tibial tuberosity transposition in patients with patella alta and no instability affects the degree of patellofemoral chondropathy and patient satisfaction after 10 years. This will allow us to educate patients regarding long-term outcomes better.