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.
In this study, a comparison is made between two types of polyp resection methods (hysteroscopic tissue removal and bipolar resectoscopy). More specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps. The aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.
Rationale: Approximately one in three cancer patients and survivors experience significant psychological distress. Previous research has shown that mindfulness-based interventions such as mindfulness-based cognitive therapy (MBCT) can help reduce distress among cancer patients. However, MBCT typically takes place in face-to-face group sessions, which are not easily accessible to many cancer patients. Blended therapist-assisted (combination of group sessions and individual online sessions) and unguided online MBCT interventions may address this problem, however, research on effectiveness of these interventions is missing. Objective: This three-armed, randomized controlled trial (RCT) evaluates the effectiveness and cost-effectiveness of blended therapist-assisted (blended MBCT) and unguided individual internet-based MBCT (online MBCT) compared to treatment-as-usual (TAU) for cancer patients. Secondly, consolidation of treatment effects is studied up to nine months post-treatment. Thirdly, possible working mechanisms and effect moderators are studied. Study design: The current study is a RCT with three arms (blended MBCT, online MBCT and TAU) with assessments at baseline (T0), mid-treatment, post-treatment (T1) and 3 months follow-up (T2). At 3 months follow-up (T2), patients in the TAU arm will be crossed over to blended MBCT or online MBCT (random allocation). Uncontrolled follow-up assessments will be conducted at 6 (T3) and 9 months (T4) follow-up. Study population: 254 adults (>18 years) who have or have had a cancer diagnosis (any stage/any type) will be randomized. Intervention: Patients will be randomly assigned with a 1:1:1 ratio to one of three groups: (1) blended MBCT: patients will be invited to a blended therapist-assisted MBCT program, consisting of 8 weekly sessions (4 online group meetings, 4 online sessions with therapist assistance, and an online silent day), in addition to TAU; (2) online MBCT: patients will be invited to an individual internet-based MBCT program without assistance from a therapist, that consists of 8 weekly sessions and a silent day, in addition to TAU; (3) TAU: patients receive usual care, which can be medical, psychological or paramedical care, except mindfulness interventions. Main study parameters/endpoints: Primary outcome is the difference in Hospital Anxiety and Depression Scale (HADS) total scores between patients in the blended MCBT and TAU arms and between the online MCBT and TAU arms post-treatment (T1).
This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.
In this study it is researched how preventive and curative healthcare for children with overweight and obesity was conducted during the Covid-19 pandemic, which barriers were noticed by professionals, and how new methods (such as e-health and telemonitorning) for coaching, communication and healthcare were used and experienced.
The general purpose of this feasibility study is to evaluate the potential impact of Pathways to Empowerment (PTE) on the four constitutional conditions of social quality for persons living in persistent poverty. PTE is a strengths-based methodology developed for social care professionals to support persons in vulnerable positions with their recovery. PTE was chosen for evaluation based on in-depth interviews about appropriate support, a literature search, and participatory action research in which the wishes of each participating municipality were explored.
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
Since intermediate vision is becoming increasingly important in our day-to-day tasks, a new IOL was introduced (Acunex Vario) with this objective in mind. This IOL provides excellent vision at far and intermediate distances up to 60 cm and with negligible photopic disturbances compared to conventional multifocal lenses. The Alcon AcrySof IQ Vivity IOL is designed to provide continuous vision from distance to intermediate while preserving contrast sensitivity and with a monofocal visual disturbance profile. So far, there are no published studies comparing these new IOL designs that offer an extended range of vision at far and intermediate distances. Objective: The primary objective of this study is to compare the binocular uncorrected intermediate visual acuity (UIVA) at 66 cm under photopic conditions 3 months postoperatively, in a series of patients bilaterally implanted with the Vario IOL versus those bilaterally implanted with the Vivity IOL. Study design: controlled double masked, randomized, prospective clinical trial Study population: patients of 18 years or older with bilateral cataracts that require cataract surgery. Intervention: One group receives bilateral implantation with the Vario IOL and the other group receives bilateral implantation with the Vivity IOL. Main study parameters: The main study parameter is the binocular UIVA at 66 cm under photopic conditions at 3 months postoperatively. Hypothesis: The investigators hypothesise that bilateral implantation with the Vario IOL is non-inferior when compared to bilateral implantation with the Vivity IOL, with regards to binocular UIVA at 66 cm under photopic conditions 3 months postoperatively. Cataract extraction in this study will proceed according to regular cataract surgery. As with any type of intraocular surgery, there is a possibility of complications due to anesthesia, drug reactions, and surgical problems. Postoperatively, there will be one extra postoperative visit, compared to standard cataract surgery follow-up. Spectacle-independency postoperatively, without photopic phenomena, is one of the major expected benefits when treating cataract (and presbyopia) with the implantation of the Vario or Vivity IOLs.
Introduction and rationale Benign airway stenosis or malacia is a frequent complication of lung transplantation occurring in 4-24% of patients, most often occurring two to nine months post-transplant. Initial therapeutic approach consists of conservative endobronchial treatment with recurrent balloon dilatation, radial incision, and electro cautery. For severe case of recurrent stenosis or malacia, airway stent placement can be considered. Different types of airway stent exist, for instance self-extendable metallic stent (SEMS), silicone stent and biodegradable airway stent. Conventional airway stents (SEMS, silicone) are associated with complications as granulation tissue and recurrent infections and can be difficult to remove. Newly developed biodegrabale stents are made of polydioxanone and disintegrate after a period of time are thought to have less side effects, and has been standard of care for the last few years. A sub selection of patients have been treated with conventional stent before treated with biodegradable stent. Research question - To assess the efficacy and efficiency of biodegradable airway stent. - Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents. - Asses if biodegradable stent lead to improvement of lung function. - Assessment of the life span of biodegradable stents.
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TETRO is a multi-center placebo-controlled double-blind randomized controlled trial with an intervention phase of 5-7 weeks and a follow-up phase of 12 months in 250 adult (18 years and older) OCD patients who show no/insufficient response to ERP, aiming to establish the cost-effectiveness of low frequency (1 Hz) rTMS to the pre-SMA (compared to sham rTMS to the pre-SMA) as adjuvant treatment to exposure with response prevention (ERP). The treatment consists of 4 times/week rTMS combined with ERP for at least 5 weeks (20 sessions), with optional extension phase of 1 or 2 weeks (maximum of 28 sessions in total).