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 a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
Rationale/objective: This study hypothesizes that offering patient-tailored and dosed information on PPI discontinuation in patients with inappropriate chronic PPI use will result in an increased discontinuation rate when compared to a conventional information folder offering all information on discontinuing inappropriate PPI use at once. Study design: Multicenter randomized controlled trial. Study population: A minimum 152 patients with chronic PPI use without a valid indication for chronic PPI use according to the NHG-guidelines will be included. Possible participants will be identified at the outpatient clinics of the departments of Internal Medicine, Gastroenterology, Rheumatology and Nephrology in the Radboud University Medical Center, Canisius Wilhelmina Hospital and Sint Maartenskliniek. Intervention: Timely informing patients on discontinuing PPI use through the Patient Journey App. Control: Conventional information, consisting of an online information folder on discontinuing PPI use. Inclusion criteria: - Patients with daily PPI use for at least 4 weeks; - Age 18-70 years. Exclusion criteria: - Chronic PPI indication according to NHG-guidelines; - Chronic PPI indication according to treating physician, despite absence of chronic PPI indication according to NHG-guidelines; - Patients that underwent anti-reflux surgery; - No understanding of the study or study procedures including the digital application (smartphone/computer skills); - No smartphone/computer available; - No informed consent; - Limited life span. Primary end point: - Discontinuation of PPI use at 2-month follow-up, defined as self-declared intake of a maximum of 1 tablet in the previous 14 days. Secondary end points: - Upper gastrointestinal symptoms or disorders that are potentially related to discontinuation of PPI use, subdivided as: - Upper gastrointestinal symptoms as measured by the Patient Assessment of Gastrointestinal Symptom Severity Score (PAGI-SYM); - Any upper gastrointestinal event that requires a doctor's visit or hospitalization. - Potential adverse drug reactions (ADRs) of PPIs, subdivided as: - Most prevalent (1-10%) ADRs according to the Medicines Evaluation Board1: obstipation, diarrhea, meteorism, abdominal pain, nausea/vomitus, headache; - Other potential ADRs requiring a doctor's visit or hospitalization. The following disorders are considered as potentially related to PPI use: any pneumonia, gastroenteritis, vitamin B12 deficiency, iron deficiency, calcium deficiency, fractures, acute interstitial nephritis or hypomagnesaemia. - Frequency of PPI use, measured monthly during follow-up, measured as number of PPI tablets per month; - Start of new medication for upper gastrointestinal symptoms, other than PPI (e.g., antacids, H2-blockers, analgesics, anti-emetics); - Association between successful discontinuation and variables such as gender, age, fear of ADRs, occurrence of potential ADRs or occurrence of rebound effect; - Change in lifestyle (BMI, smoking status and alcohol usage); - Patient Journey App usability as measured by the System Usability Score (SUS); - Self-management behavior as measured by the short Patient Activation Measure (PAM-13); - Recurrent PPI use, defined as the intake of more than 1 PPI tablet in the previous 14 days measured as self-declared intake during follow-up after successful discontinuation during follow-up.
Exoskeletons can be used for rehabilitation, as assistive device for patients, or to support workers during strenuous tasks. To fulfil their purpose, they need to apply forces to the user's musculoskeletal system. The forces are transmitted at skin level through an interface, often in the form of cuffs. Adverse events causing discomfort and injuries to the skin and underlying tissue can be attributed to those interaction forces. While there is some information about safe limit values for impact forces or pressure and shear applied for short durations, little is known regarding comfort and safety thresholds for repetitive forces applied over long durations as is the case in exoskeleton use. This study therefore aims at gaining new knowledge on safe and limit values, based on discomfort (staying below pain threshold), for continuous repetitive shear and normal forces applied through a cuff. Therefore, the primary objective is to determine comfort thresholds for prolonged exposure to repetitive normal and shear stress exerted to the human thigh via a cuff with straps, using different force patterns comparable to those exerted during exoskeleton use. The secondary objectives are to determine the feasibility of the experiment, the influence of subject characteristics on comfort thresholds, the occurrence of skin injuries or other negative signs, and whether characteristics of muscle activity can be related to discomfort.
Rationale: Lumbar spine surgery is associated with high postoperative pain scores and analgesic use, despite use of multimodal analgesia. The erector spinae plane block (ESPB) is a promising locoregional anesthetic technique for this type of surgery. The literature is not yet conclusive about the effectiveness of this technique on reducing postoperative pain intensity. Objective: The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain intensity after lumbar spinal fusion surgery compared to placebo. Study design: The study is designed as a prospective mono-centre, randomized, double-blinded, placebo-controlled trial. Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion surgery involving one to four fusion levels. Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo at the end of surgery. Main study parameters/endpoints: Main study parameter is pain intensity upon emergence from anesthesia measured with the Numeric Rating Scale. A minimal clinically important difference is considered to be a decrease of 1.5 points. Secondary endpoints are pain intensity during hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay, quality of recovery at discharge. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Sint Maartenskliniek is experienced in applying locoregional analgesia, the use of ropivacaine and using sonography. The procedure of administering ESPB has a very low risk of complications. Receiving placebo is justifiable because this group will not be withhold standard treatment. The risks of receiving placebo are negligible. The patients will visit the clinic at regular follow-up moments.
In this study, a comparison is made between two types of polyp resection methods (hand driven and motor driven morcellation). 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.
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.
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.
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.
Rationale: Dupilumab has proven to be effective and safe in several large randomized controlled trials. However, study populations in RCT's represent only a small proportion of severe asthma patients treated in real life circumstances. Therefore, real-life studies provide data complementary to RCT's derived from a more diverse and heterogeneous group of patients. This study is unique in that it represents a large population of European patients that are not represented in the Global Registry. Objective: To collect and analyse efficacy and safety data in severe asthma patients treated with dupilumab in a real-life setting. Study design: Single center, retrospective cohort analysis of severe asthma patients treated with dupilumab, as decided by the treating physician. Setting: Severe Asthma Expert Center Franciscus Gasthuis & Vlietland, Rotterdam Study population: All patients that started with dupilumab from jan 2019 (early access program) until June 2020 are eligible for the study. They should be 18 years or older, with severe T2 high asthma and treated with at least one dose of dupilumab. Main study parameters/endpoints: - Primary endpoint: To assess changes in annual exacerbation rate between baseline and after 12 months treatment in severe asthma patients treated with dupilumab. - Secondary endpoints: To collect data on ACQ, OCS use, FEV1, treatment response rate, influence of co-morbidities and safety. Methods: Exacerbation history and patient characterization will be done at baseline. We aim to include patients in the analysis that had at least one administration of dupilumab (intention-to-treat). Treatment response evaluation is done at 12 months. Final evaluation of efficacy and safety is done at 12 months of treatment. We aim to enroll at least 120 patients in the study. Data collection will be done in Castor Electronic Data Capture. Of the 120 patients scheduled for inclusion, all have already started treatment and data will be collected retrospectively at the predefined time points. Patient data will be handled confidentially. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since this is a retrospective cohort analysis there are no extra visits, interventions or procedures needed. Therefore, there is no increased burden or risk for the patients involved.