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 purpose of this study is to investigate two independent Virtual Reality interventions for self-criticism and self-compassion and the use of perspective-change in these interventions.
The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.
Crohn's disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases (IBD) with a heterogeneous disease course. Recurrent mucosal inflammation or chronic subclinical inflammation results in damage to the bowel and complications like stenosis, fistula and colorectal cancer. Therefore, tight control of mucosal inflammation is important to prevent complications. The goal of this multicenter observational cohort study is to determine the best remote monitoring tool for predicting mucosal inflammation in adult patients with inflammatory bowel disease, relative to the gold standard endoscopy. Participants will be asked to fill out questionnaires regarding disease activity (MIAH, mHI, IBD-control, Manitoba IBD Index, p-HBI/p-SCCAI), perform a FC home test and collect one stool sample for routine laboratory calprotectin measurement, before the start of the bowel preparation for the ileocolonoscopy. During this ileocolonoscopy, endoscopic disease activity will be determined. .
The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse. The primary question it aims to answer is: • how many patients succeed learning self-management if offered a standardized training? Secondary outcomes are: - how many patients are willing to learn self-management? - what patient factors contribute to successfully learning self-management and willingness to self-manage? - how satisfied are patients with pessary therapy and self-management? - the occurrence of side-effects - continuation and quitting of pessary therapy and self-management - cross-over to surgery - number of visits to doctor because of pessary therapy - healthcare costs Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary). Researchers will compare the self-managing patient to the non-self-managing patients.
In this study, the investigators hypothesize that the reference product (SalbR/Ventolin) is more effective than SalbG (Salbutamol Sandoz) at improving the lung function in children with asthma, and that this difference increases alongside the severity of the airway resistance. (Null hypothesis: There is no difference). This could be explained by different properties and deposition of the aerosol. Purpose of this research: Rejecting the null hypothesis. This is based on the answers to the questions below. Research questions: 1. Is there a difference between the increase in FEV1 (and FVC) after 100 μg SalbG versus FEV1 after 100 μg SalbR in children aged 4-14 years with insufficient asthma control? (primary question) 2. Is there a difference in the subjective feeling of the children after inhalation with 100 μg SalbR and after 100 μg SalbG, measured with a VAS score? 3. Is the increase in FEV1 (and FVC) in children with asthma between 4-14 years of age with insufficient asthma control after inhalation of 400 μg SalbR different than after inhalation of 400 μg SalbG? 4. Is there a difference in the subjective feeling of the children after inhalation with 400 μg SalbR and after 400 μg SalbG, measured with a VAS score?
About 5-15% of the general population experience a chronic ringing, buzzing, hissing or roaring sound in one or two ears, without any external source. This so-called tinnitus can be present in people with normal hearing, but often coexists with hearing loss. Most people suffering from tinnitus can cope with it, however a minority experiences emotional distress or cognitive dysfunction as a result of the tinnitus, called tinnitus disorder. People suffering from tinnitus disorder regularly complain about an increased experienced effort when listening to speech or other sounds in daily life situations. As this has never been proven scientifically, the investigators aim to evaluate the effect of the tinnitus percept and tinnitus disorder on experienced listening effort by comparing listening effort between a population with tinnitus disorder and a population without tinnitus.
Rationale: To unravel the role of dopamine in gating of working memory, motivation and learning. Objective: The primary objective of this study is to isolate effects of blocking D2 receptor stimulation on gating of working memory, reinforcement learning and reward-based motivation, and their associated physiological changes (measured with fMRI and eye tracking). The secondary objective is to assess the degree to which the effects of D2 receptor action vary as a function of proxy measures of baseline dopamine levels. Study design: A double-blind placebo controlled within-subject design will be employed, in which young healthy participants are tested twice, once on placebo, and once on a low oral dose (400mg) of the D2 receptor antagonist sulpiride. This design and drug dose is commonly used in our lab without side effects (previously approved CMO protocols 2011/204, 2008/078 & 2016/2646). Study population: Healthy human participants, 18 - 45 yr old. We will recruit 46 participants. Intervention: Participants will receive both 400 mg sulpiride and placebo, in separate sessions in a counterbalanced order. Main study parameters/endpoints: BOLD signal measured with fMRI, and behavioural performance on cognitive tasks. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will attend 3 study sessions: A screening session and 2 pharmaco-fMRI sessions (sulpiride and placebo). Participants will complete a baseline battery of tasks and questionnaires, a structural MRI scan, as well as a battery of tasks both in and outside the scanner. On the day preceding each pharmaco-fMRI session, participants will have to adhere to some simple restrictions with respect to medication, alcohol and drug intake. On the day of testing participants will have to refrain from smoking and stimulant-containing drinks. Sulpiride can be administered safely without any relevant risk of serious adverse events and has been approved for clinical use in the Netherlands.
The proposed study is a prospective, non-randomized, pilot study to test the impact of the Allurion Digital Behaviour Change Intervention (DBCI) in participants who have been treated with the Allurion™ Gastric Balloon System. The study will include a nested qualitative and quantitative evaluations of the intervention from both the participant and Allurion provider perspective.
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
Transgender and gender diverse (TGD) individuals most often choose for phalloplasty as a means to create masculine external genitalia. The neophallus created in phalloplasty is usually insufficient for penetrative sexual intercourse due to the lack of erectile structures. Therefore, implantation of an internal erectile prosthesis or use of an external device or epithesis is required. Internal prostheses are the main method for attaining penile rigidity after phalloplasty, but they carry a high risk of complications. Previous research has shown that up to 22% of prostheses for cisgender men were explanted due to various reasons, including infection, erosion, and malfunction within 20 months. The lack of reliable and durable erectile devices leads to a large proportion of patients either choosing phalloplasty but never going for the placement of an erectile prosthesis or completely abandoning the idea of GGAS under the form of phalloplasty. Secondarily, TGD individuals may be concerned about complication rates and likely need for additional surgeries associated with penile implant surgery. Therefore, alternative options for transgender and gender non-conforming patients after phalloplasty are needed. These alternatives may be surgical or non-surgical. External penile epitheses or penile splints were originally designed for cisgender men with erectile dysfunction but have been used experimentally by post-phalloplasty transgender men. While there is no data on the usability and durability of penile epitheses in a TGD population, they may be a viable alternative to an internal penile prosthesis after phalloplasty. Penile lifters or splints, marketed as ElatorTM or ErektorTM, are commercially available and consist of two rigid rings connected by rigid metal rods. The biggest of two rings is placed around the base of the phallus, and the second ring is placed behind the coronal ridge. By connecting the rods to the ring at the base of the penis, tension and rigidity between the two rings is created, allowing the user to penetrate their partner and remove the device after intercourse. The current study aims to extend the knowledge on these external devices by comparing them to the implantation of an internal penile prosthesis in post-phalloplasty transgender patients.