Komlã³, Hungary

Home Treatment for Individuals Suffering From Severe Addictive Disorders

Effects of EEG- Microstate Neurofeedback on Attention and Impulsivity in Adult Attention-deficit/Hyperactivity Disorder (ADHD) and Neurotypical Controls

Neurofeedback (NFB) is a broadly used method that enables individuals to self-regulate one or more neurophysiological parameters. In the case of electroencephalography (EEG) the parameters most often used so far are slow cortical potentials (SCPs), coherence training and frequency training. Protocols based on these measures have been applied to many clinical populations exhibiting abnormal EEG patterns including schizophrenia, insomnia, dyslexia, drug addiction, autistic spectrum disorder and attention deficit/hyperactivity disorder (ADHD). Today, the most widely used neurofeedback protocol for the ADHD population is based on the theta/beta ratio (TBR). However more recent studies have failed to replicate this finding of elevated TBR as a diagnostic feature in ADHD, which was also confirmed in a meta-analysis. These divergent results motivate the need for research to explore new markers to diagnose and treat ADHD. In a recent study, Férat and colleagues proposed EEG microstate analysis as a new framework to study ADHD. Microstate analysis models spontaneous EEG as a sequence of states defined by recurring appearance of a given distribution of scalp potentials. The authors observed a significantly increased contribution of one specific state commonly referred to microstate D in the ADHD population compared to healthy subjects. This state is often associated with attentional functions and brain regions in the dorsal attention networks are involved . It would therefore be interesting to study the causal link between this microstate and attention by manipulating this biomarker with neurofeedback. In this context, a recent study by Hernandez and colleagues has already demonstrated that healthy participants were able to control such brain microstates by neurofeedback. The aim of the present study is to test whether patients with ADHD are also capable of self-regulating their microstate dynamics. In the light of recent findings on EEG microstate and the ADHD population, the hypothesis is that microstate D could be a potential functional biomarker of ADHD. To test it, the proposal is to modulate this microstate using a neurofeedback training protocol directly targeting microstate parameters. According to the main hypothesis, changes in microstate parameters should be correlated with change in attentional and impulsive behaviour. To answer this question, a two-session study was designed, where participants will perform a continuous performance task (CPT) before and after 30 minutes of microstate-based neurofeedback training. During one of the sessions participants will be trained to upregulate microstate parameters, while during the other one, they will be trained to downregulate the same parameters. Intra- and across-section statistical contrasts, both in terms of brain activity changes and behavioural performance, should provide evidence to evaluate the impact of microstate changes relative to behaviour. In addition, and according to a large number of studies on ERP components in ADHD patients the recording of event related potentials (ERPs) during the behavioural task could help us understand the neurophysiological changes linked to attention and impulsivity measures.

Microbiota and Pancreatic Cancer Cachexia

Aim: Evaluating the effects of fecal microbiota transplantation (FMT) from 6 newly diagnosed cachectic and 6 non-cachectic pancreatic cancer patients, and 12 healthy age-and sex-matched volunteers on several cachexia-related parameters of 96 germ-free mice (4 per donor) over a 30-day period. The fecal material of all 12 pancreatic cancer patients will be collected at diagnosis before any cancer treatment onset. Hypothesis: FMT of cachectic patients with pancreas cancer, naïve of any anti-cancer treatment and artificial nutrition, into germ-free mice impairs weight gain, in contrast to FMT of non-cachectic patients and healthy controls.

Real-time Deflectable Guidewire in Neuro-interventions Study

OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial

This is a randomized, controlled, factorial, superiority trial to evaluate the viral efficacy of DAA (nirmatrelvir/r) + DAA (remdesivir)∞ versus nirmatrelvir/r alone and of 5 days versus 10 days of nirmatrelvir/r in immunocompromised patients diagnosed with asymptomatic or mild to moderate COVID-19. The primary objective is to assess whether (i) a combination antiviral therapy of two DAA (nirmatrelvir/r + remdesivir)∞ And/or (ii) an increase in nirmatrelvir/r duration from 5 to 10 days improves viral efficacy by decreasing the SARS-CoV-2 positivity rate by real time RT-PCR (CT<32) in nasopharyngeal swabs at D10. Patients will be eligible if they are immunocompromised, have confirmed asymptomatic SARS-CoV-2 infection or mild to moderate COVID-19, regardless of symptoms onset, provided that they have no contra-indication to any of the study drugs. A total of 256 patients will be included in France and Switzerland. Participants not eligible for randomisation or who refuse to participate to the trial for any reason will be proposed to be included in an exploratory non comparative cohort (maximum 97 participants).

Effectiveness of a Mobile App in Reducing Therapeutic TAT in an Emergency Department

The study objective is to evaluate whether the use of the PIMPmyHospital app alters emergency departments (ED) physicians and nurses' temporal efficiency to learn about laboratory results more quickly while actively working in an ED. Temporal efficiency will be assessed by measuring the time between the release of the laboratory results in the clinical information system and their acknowledgement by these clinicians. Information regarding the app has been published previously (doi.org/10.3390/jpm12030428). The investigators will conduct an 18-month, single center, non-equivalent comparison group, pre-post study. The study will compare the control and experimental groups on outcome measures before (12-month period) and after (6-month period) the intervention consisting of the use of the app. The study will take place in the pediatric ED of a tertiary referral and major trauma hospital in Switzerland, with an annual volume of 35,000 visits. Eligible participants will be postgraduate residents pursuing a <6-year residency in pediatrics, pediatric emergency medicine fellows, and registered nurses from the pediatric ED (aged > 18 years). Written informed consent will be obtained from each participant in the interventional group after full information disclosure prior to study participation. Before the implementation of the app, electronic medical records (EMR)-based data from the past 12 months will be collected retrospectively. These data include the times (i.e., HH:MM:SS) that results issued by the central laboratory were available on the institutional's EMR, as well as the times at which these results were accessed by caregivers via conventional computerized workstations. (ii) After the implementation of the app, data will be collected prospectively over a 6-month period of use. This will include the times (HH:MM:SS) when the results issued by the central laboratory are made available on caregivers' mobile app and access times, as well as concurrent or preferred access times on the conventional computerized workstations should this occur. Individual acceptance of the app on the first day (a priori), at 1 week, and then on the last day of the intervention (6 months) will be evaluated through the Unified Theory of Acceptance, and Use of Technology (UTAUT). Usability of the app will be measured by the System Usability Scale (SUS). The primary outcome will be the mean elapsed time in minutes between the delivery of the lab results and the caregiver accessing them, both before and after the implementation of the app.

Radiosurgery Induced Ototoxicity in Patients Treated for a Vestibular Schwannoma

The study will have a retrospective part and a prospective part. The retrospective study will be based on a series of consecutive patients with vestibular Schwannoma (VS) treated either with stereotactic radiosurgery (SRS) or followed up radiologically between 2014 and 2021 in our institution. The following data will be retrieved from the hospital archiving system and will be subsequently analyzed: demographics, patient characteristics, details regarding SRS planning, clinical baseline and follow-up data, hearing, vestibular and taste function assessment initially and during follow-up, presence of additional symptoms (tinnitus, hemifacial spasm, trigeminal neuralgia), radiosurgery parameters and MRI characteristics of tumors. The following parameters will be retrospectively measured on MRI images by an experienced radiologist in each VS: tumor volume, ratio of brain stem compression, tumor shape and distance to the fundus of the internal auditory canal, length of the tumor in the internal auditory canal, and signal intensity in the cochlea and vestibule. The MRI textural features extracted from whole tumor segmentation of VSs will be calculated and analyzed with MatLab®. They include shape features, first order and second order textural features. The prospective study part aims to obtain more precise and predefined follow-up data from patients treated either with SRS or followed up conservatively from now on. Our institution's multidisciplinary skull base tumor board will be responsible for treatment decisions independently of the study. It will be a single-center observational cohort study investigating the respective impact of tumor morphology and SRS on the inner ear, the facial nerve function, and the quality of life of these patients. As data collection will be done prospectively, MRI acquisition parameters will be standardized, as well as quantification of hearing, vestibular, facial nerve function, and quality of life. Additionally, the investigators will analyze the characteristics of the tumors and several parameters of the irradiation protocol to develop predictive models for ototoxicity.

Distal Versus Conventional Transradial Artery Access for Coronary Catheterization in Patients With STEMI

Gaining vascular access is the first, mandatory step for undertaking percutaneous coronary angiography and interventions. The recent guidelines, published by European Society of Cardiology (ESC), American College of Cardiology (ACC), American Heart Association (AHA) and Society for Cardiovascular Angiography and Interventions (SCAI), propose TRA as the gold standard for acute coronary syndromes (ACS), chronic coronary syndrome (CCS) percutaneous coronary interventions (PCI). Recently, a novel distal transradial, through anatomical snuffbox, approach has been proposed. The existing literature has evaluated distal transradial access (dTRA) as a feasible and safe approach, with faster hemostasis, lower rates of periprocedural complications and reduced incidence of radial artery occlusion (RAO). Mutual point of all the previous RCTs is that excluded patients suffering from ST-elevation Myocardial Infraction (STEMI). Aim of the present study is to compare dTRA versus conventional TRA access in patients with STEMI undergoing coronary angiography and interventions regarding peri- and post-procedural characteristics.

The ReTAVI Prospective Observational Registry

Between 1.4 and 2.8% of all patients undergoing transcatheter heart valve (THV) implantation require a second THV implanted into the previously implanted THV because of clinically significant aortic regurgitation [1-3]. 90% of THV-in-THV implants were considered successful although the mortality in the redo-TAVI group was higher at similar STS risks as in those with a successful first implant. Redo-TAVI may also be a promising treatment strategy in degenerated THVs, but there is insufficient knowledge which strategy and valve design may result in the best outcomes [4]. Evidence so far reported is based on case reports and small case series, but not on a prospective, multicenter documentation. Currently, ~ 5% of THV are implanted in degenerated surgical bioprosthetic valves. With the expanded use of THV for treatment of lower risk patients with severe aortic stenosis (sAS), it is estimated that the number of patients requiring re-treatment for THV failure is likely to rise within the next years.

Intrathecal Double Checkpoint Inhibition

The treatment regimen within the IT-IO study consists of intrathecal administration of nivolumab/ipilimumab in combination with systemic combined nivolumab/ipilimumab. The scheme of administration of systemic nivolumab/ipilimumab corresponds to the current standard of care for non-small cell lung cancer and for melanoma patients.