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NCT ID: NCT03677583 Recruiting - Clinical trials for Gastrointestinal Complication

Duckweed Intake Study

DIS
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

The study aims to study the impact of frequent intake of 150-180 gram duckweed on gastrointestinal complaints and several other health related biomarkers. The study has a randomised parallel design. Two different treatments will be evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with control/spinach meals. At the start and at the end of the intervention we will collect a blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing, health complaints or other adverse effects will be collected daily during intervention and up to two days after the intervention.

NCT ID: NCT03677050 Recruiting - Colorectal Cancer Clinical Trials

Effect of Individualized Patient Education Including Drinking Advice Using an App

Start date: September 14, 2018
Phase: N/A
Study type: Interventional

Study evaluating the effect of a personalized smart phone application in addition to standard care on bowel preparation scores, compared to standard care alone.

NCT ID: NCT03666013 Recruiting - Muscle Weakness Clinical Trials

Mitochondria and Muscle Health in Elderly

ELMIH
Start date: June 27, 2017
Phase:
Study type: Observational

The aim of this study is to characterize the relation between skeletal muscle mitochondrial metabolism and muscle health in elderly, physically compromised humans. To study this relation, we will perform a cross-sectional study in well-defined, distinct subject groups. Thus, to obtain insight in the relation between mitochondrial health and muscle function, we will not only compare subjects that differ in mitochondrial function (based on physical activity) but also select for subjects with high- versus low muscle function.

NCT ID: NCT03664258 Recruiting - Clinical trials for Non-muscle-invasive Bladder Cancer

A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)

ANTICIPATE X
Start date: June 6, 2018
Phase:
Study type: Observational

Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).

NCT ID: NCT03664011 Recruiting - Healthy Clinical Trials

A Study in Healthy Men to Test How BI 730357 is Processed by the Body

Start date: September 10, 2018
Phase: Phase 1
Study type: Interventional

The main objectives of the study are as follows: - To assess the mass balance recovery of [14C]-radioactivity in urine and faeces after a single oral dose of 50 mg BI 730357 BS (C-14) in healthy male subjects - To provide plasma, urine, and faecal samples for metabolite profiling and structural identification

NCT ID: NCT03658759 Recruiting - Clinical trials for Out-Of-Hospital Cardiac Arrest

Rapid Response VA-ECMO in Refractory Out-of-hospital Cardiac Arrest

RESuSCITATe
Start date: July 2, 2018
Phase:
Study type: Observational [Patient Registry]

A selected group of patients with refractory cardiac arrest may benefit from inhospital treatment and this may warrant transfer to the hospital with ongoing CPR. In patients with VF or ventricular tachycardia (VT) the underlying cause may be reversible and damage to other organs is limited at the time of the arrest. Many patients will have a coronary event that can be treated by angioplasty. However, up to now absence of ROSC poses a barrier for angioplasty, and most patients are therefore not even transported to a hospital. With the use of extra corporeal membrane oxygenation (ECMO) the circulation can be restored immediately, providing time to diagnose and treat the underlying cause of the cardiac arrest. International cohort studies show that a strategy of pre-hospital triage and transport to a cardiac arrest expertise center for "rapid-response" ECMO and coronary revascularization is feasible and improves survival. A clinical pathway will encompass intense cooperation and optimal logistics between several paramedical and medical disciplines, i.e. from prehospital ambulance service to intensive care. Incorporation of mechanical chest compressions devices (LUCAS™), rapid-response veno-arterial (VA-)ECMO (Cardiohelp, Maquet), and ECMO assisted revascularization in a dedicated clinical pathway will offer a potential lifesaving treatment option that is in accordance with the recommendations in the current Guidelines. The aim of the study is to investigate the feasibility of a new local clinical pathway in our hospital to provide ECPR for refractory OHCA patients.

NCT ID: NCT03658200 Recruiting - Pulmonary Disease Clinical Trials

Fully Automated Scan Technique Optimisation of Scan Timing in Chest CT

[FAST-START]
Start date: April 5, 2018
Phase: N/A
Study type: Interventional

Computed Tomography Angiography (CTA) is a non-invasive imaging tool widely used for various indications. Contrast media (CM) is used to enhance the intravascular lumen and organ parenchyma, depending on the indication. Recent technical advances in CT scan techniques allow for a very fast scan acquisition with substantially increased image quality in terms of temporal and spatial resolution. However, with faster scan acquisition, challenges arise with regard to CM bolus timing. The risk of outrunning the CM bolus in these fast acquisitions is higher, resulting in a decreased intravascular attenuation and subsequent hypothetical increase in non-diagnostic image quality. Previous studies have investigated the reduction of CM volume. When reducing the CM volume, the total injection time decreases and the window of peak enhancement shortens and becomes more narrow. The latter increases when injecting small CM volumes with higher flow rates. Although the peak enhancement increases, the window of peak enhancement decreases more rapidly. Thus, when administered with the same flow rate, the peak of the enhancement curve will be lower, narrower and faster compared to larger CM volumes. This, in combination with the faster scan acquisition makes the timing of the start of the scan highly important, since scanning at the peak enhancement is necessary to achieve a diagnostic image quality. New bolus tracking auto-delay software (Fully Automated Scan Technique, FAST, Siemens Healthineers) automatically estimates the delay needed to scan at the peak of the enhancement curve. With help of this software, the optimal individual scan delay and enhancement can be achieved, and the risk of non-diagnostic scans should decrease. Therefore, this study aims to evaluate the performance of the Bolus Tracking Auto-Delay (FAST) software in patients receiving a standard chest CT with regard to the number of non-diagnostic scans (< 300 HU) and compare this with standard care (manual set pre-scan delay).

NCT ID: NCT03653806 Recruiting - Clinical trials for Acute Hypoxemic Respiratory Failure

Automated Analysis of EIT Data for PEEP Setting

Start date: November 21, 2017
Phase:
Study type: Observational

First: to develop a computerized algorithm for automated analysis of the electrical impedance tomography (EIT) data. The algorithm calculates the "optimal" positive end-expiratory pressure (PEEP) and inspiratory pressure defined as the "optimal" balance between stretch, ventilation distribution and collapse. Second: to compare the results of the algorithm with the current standard of care clinical judgement of an experienced ventilation practitioner.

NCT ID: NCT03652883 Recruiting - Clinical trials for Tailored Implementation: Online ItFits-toolkit

ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth

ImpleMentAll
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The ImpleMentAll (IMA) project aims to examine the effectiveness of tailored implementation compared to usual implementation of Internet-based Cognitive Behavioural Therapy (iCBT) for patients suffering from common mental disorders in routine practice. Common mental health disorders account for an alarming proportion of the global burden of disease. Being regarded as an evidence-based psychotherapeutic eHealth intervention, Internet- based Cognitive Behavioural Therapy (iCBT), has the potential to answer to this societal challenge by providing an efficacious and efficient treatment from which more people can benefit. ImpleMentAll will develop, apply, and evaluate tailored implementation strategies in the context of on-going eHealth implementation initiatives in the EU and beyond. The objectives are: 1. To develop a generic Integrated Theory-based Framework for Intervention Tailoring Strategies (the ItFits-toolkit) for data-driven tailored implementation of evidence-based eHealth services. 2. To demonstrate the impact of the ItFits toolkit on the implementation of eHealth for common mental disorders. 3. To disseminate the validated toolkit in various healthcare contexts across Europe. Following a stepped-wedge trial design, the ItFits-toolkit will be introduced in twelve implementation sites in nine countries, and evaluated for its effectiveness in obtaining implementation success. An in-depth process evaluation using a realist evaluation methodology will provide information about the particularities of tailored implementation and the application of the ItFits-toolkit in real implementation work. The resulting ItFits-toolkit will enable data driven evaluation of eHealth implementation projects and its methods, materials, and strategies will provide concrete guidance on tuning implementation interventions to local determinant of practice across a variety of health care systems.

NCT ID: NCT03652597 Recruiting - Clinical trials for Major Depressive Disorder

Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: Replication and Dose-response.

Start date: March 6, 2018
Phase: N/A
Study type: Interventional

Autonomic regulation is disturbed in patients with major depressive disorder (MDD), indicated by a higher heart rate (HR) and lower heart rate variability (HRV). Moreover, the heart seems to be functionally connected via the vagus nerve (VN) to other brain structures that are dysregulated in depression, such as the subgenual anterior cingulate cortex (sgACC), and the dorsolateral prefrontal cortex (DLPFC), suggesting dysregulated network function in MDD. In line with this network dysregulation hypothesis of MDD, optimal transcranial magnetic stimulation (TMS) sites are currently thought to be those that show functional connectivity to the sgACC such as the DLPFC and multiple studies have shown that stimulation of the DLPFC, sgACC and nervus vagus decreased heart rate, suggestive of parasymphatetic action. It is hypothesized that this influence on parasympathetic activity can be used as a functional outcome measure reflecting adequate targeting of the DLPFC-sgACC network, similar to the motor evoked potential (MEP) as functional key measure for primary motor cortex stimulation. Recently, a pilot study was conducted, proposing a new functional neuronavigation method for localizing the frontal area representation of DLPFC-sgACC connectivity using HR, called: Neuro-Cardiac-Guided TMS (NCG-TMS), which is being replicated in the current study. .