Inclusivity is child's play: pilot study on usability, acceptability and user experience of a sensory-motor PC game for children with cerebral palsy (GiocAbile).

Background: The use of video games in rehabilitation settings is gaining increasing popularity. However, the lack of commercial video games suitable for children with disabilities and the disappointing user experience of serious games limit their applicability. The aim of this study was to assess the usability, acceptability and user experience of GiocAbile, an active video game for children with cerebral palsy (CP).

Congenital isolated unilateral third nerve palsy in children: the diagnostic contribution of high-resolution MR imaging.

Purpose: To describe the neuroanatomical correlates of unilateral congenital isolated oculomotor palsy by means of high-resolution MRI.

Methods: Children with a clinical diagnosis of congenital isolated oculomotr palsy and with a high-resolution MRI acquisition targeted on the orbits and cranial nerves were selected and included in the study. An experienced pediatric neuroradiologist evaluated all the exams, assessing the integrity and morphology of extraocular muscles, oculomotor, trochlear and abducens nerves as well as optic nerves and globes.

Additive Manufacturing of Spinal Braces: Evaluation of Production Process and Postural Stability in Patients with Scoliosis.

Spinal orthoses produced using additive manufacturing show great potential for obtaining patient-specific solutions in clinical applications, reducing manual operations, time consumption, and material waste. This study was conducted to evaluate the production process of spinal orthoses produced by additive manufacturing, and to test the effects of 3D-printed braces on postural stability in patients with adolescent idiopathic scoliosis and osteogenesis imperfecta. Ten patients were recruited consecutively and were asked to wear a spinal orthosis produced by additive manufacturing for 2 weeks.

A Comparative Study for Material Selection in 3D Printing of Scoliosis Back Brace.

In recent years, many research studies have focused on the application of 3D printing in the production of orthopaedic back braces. Several advantages, such as the ability to customise complex shapes, improved therapeutic effect and reduced production costs place this technology at the forefront in the ongoing evolution of the orthopaedic sector. In this work, four different materials, two of them poly(lactic acid) (PLA) and two of them poly(ethylene terephthalate glycol) (PETG), were characterised from a thermal, mechanical, rheological and morphological point of view.

DBB - A Distorted Brain Benchmark for Automatic Tissue Segmentation in Paediatric Patients.

T1-weighted magnetic resonance images provide a comprehensive view of the morphology of the human brain at the macro scale. These images are usually the input of a segmentation process that aims detecting the anatomical structures labeling them according to a predefined set of target tissues. Automated methods for brain tissue segmentation rely on anatomical priors of the human brain structures.

Lentiviral haematopoietic stem-cell gene therapy for early-onset metachromatic leukodystrophy: long-term results from a non-randomised, open-label, phase 1/2 trial and expanded access.

Background: Effective treatment for metachromatic leukodystrophy (MLD) remains a substantial unmet medical need. In this study we investigated the safety and efficacy of atidarsagene autotemcel (arsa-cel) in patients with MLD.

Methods: This study is an integrated analysis of results from a prospective, non-randomised, phase 1/2 clinical study and expanded-access frameworks.

Medical Device Development for Children and Young People-Reviewing the Challenges and Opportunities.

Development of specific medical devices (MDs) is required to meet the healthcare needs of children and young people (CYP). In this context, MD development should address changes in growth and psychosocial maturation, physiology, and pathophysiology, and avoid inappropriate repurposing of adult technologies. Underpinning the development of MD for CYP is the need to ensure MD safety and effectiveness through pediatric MD-specific regulations.

The high rate of spontaneous migration of small size common bile duct stones may allow a significant reduction in unnecessary ERCP and related complications: results of a retrospective, multicenter study.

Introduction: Common bile duct stones (CBDS) can spontaneously migrate through the duodenal papilla. In this case, ERCP could be unnecessary and a significant rate of complications could be avoided. In this study, we aim at retrospectively evaluating the rate of spontaneous stone passage in patients with an imaging diagnosis of CBDS and at analysing the factors associated to spontaneous stone migration.

Learning My Way: A Pilot Study of Navigation Skills in Cerebral Palsy in Immersive Virtual Reality.

Human navigation skills are essential for everyday life and rely on several cognitive abilities, among which visual-spatial competences that are impaired in subjects with cerebral palsy (CP). In this work, we proposed navigation tasks in immersive virtual reality (IVR) to 15 children with CP and 13 typically developing (TD) peers in order to assess the individual navigation strategies and their modifiability in a situation resembling real life. We developed and adapted to IVR an application based on a 5-way maze in a playground that was to be navigated to find a reward.

Inflammatory bowel disease in a colorectal cancer screening population: Diagnosis and follow-up.

Background: Inflammatory bowel disease (IBD) is usually diagnosed in subjects with gastrointestinal symptoms, but may also be asymptomatic and diagnosed incidentally.

Aims: to determine the prevalence of IBD in asymptomatic adults.

Methods: we identified subjects who underwent colonoscopy between 1 September 2013 and 31 August 2019 in a regional colorectal cancer screening program with endoscopic findings suggestive of IBD, and retrieved their clinical, histological and therapeutic information.

Characterizing White Matter Tract Organization in Polymicrogyria and Lissencephaly: A Multifiber Diffusion MRI Modeling and Tractography Study.

Background And Purpose: Polymicrogyria and lissencephaly may be associated with abnormal organization of the undelying white matter tracts that have been rarely investigated so far. Our aim was to characterize white matter tract organization in polymicrogyria and lissencephaly using constrained spherical deconvolution, a multifiber diffusion MR imaging modeling technique for white matter tractography reconstruction.

Materials And Methods: We retrospectively reviewed 50 patients (mean age, 8.

Efficacy of a novel self-assembling peptide hemostatic gel as rescue therapy for refractory acute gastrointestinal bleeding.

Background: Acute gastrointestinal bleeding (AGIB) results in significant morbidity and mortality. Topical hemostatic products have been developed for endoscopic use to help in the management of difficult bleeding. Our aim was to demonstrate the ease of use, safety, and efficacy of PuraStat, a novel hemostat, to control AGIB.

Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial.

Background: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit).

Efficacy of withdrawal time monitoring in adenoma detection with or without the aid of a full-spectrum scope.

 Withdrawal time (WT) monitoring and full-spectrum endoscopy (FUSE) have been suggested to increase adenoma detection rate (ADR) due to more accurate evaluation of the hidden areas of the colon. We aimed to evaluate the efficacy of WT monitoring and FUSE on ADR.  This was a prospective observational study involving consecutive outpatients, aged 18 to 85 years, undergoing colonoscopy with unselected indications.

Comparison of asymmetric (low morning-dose) and standard split-dose regimen of PEG plus bisacodyl for bowel preparation: A randomized controlled trial.

Background: Reducing the morning dose of PEG solution may be a reliable strategy to improve the patient compliance of split-dose regimens without affecting efficacy of bowel cleansing.

Aims: to compare the efficacy for bowel cleansing of an asymmetric split-dose regimen (25% of the dose on the day of colonoscopy and 75% on the day before) with the standard split-dose regimen.

Methods: Outpatients were enrolled in a randomized, single-blind, non-inferiority clinical trial.

[Palliative care in the cardiac setting: a consensus document of the Italian Society of Cardiology/Italian Society of Palliative Care (SIC/SICP)].

Palliative care is recognized as an approach that improves quality of life of patients and families facing life-threatening illnesses. This is achieved through prevention, early identification, assessment and treatment of symptoms and other psycho-social, spiritual and economic issues. Palliative care is not dependent on prognosis and can be delivered as "simultaneous care", together with disease-modifying treatments and adequate symptom relief.

Diagnostic yield and miss rate of EndoRings in an organized colorectal cancer screening program: the SMART (Study Methodology for ADR-Related Technology) trial.

Background And Aims: The EndoRings add-on has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty about their correspondence. The aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia.

Systematic review: Features, diagnosis, management and prognosis of hepatic hematoma, a rare complication of ERCP.

Background: Hepatic hematoma (HH) is a rare but severe adverse event following endoscopic retrograde cholangiopancreatography (ERCP).

Aims: To perform a systematic literature review and describe two additional cases, one of which presenting multiple subcapsular/intrahepatic hematomas after ERCP.

Methods: The literature review was performed in PubMed/MEDLINE, EMBASE, and SCOPUS to identify all cases reporting on HH after ERCP.

Radiological imaging markers predicting clinical outcome in patients with metastatic colorectal carcinoma treated with regorafenib: post hoc analysis of the CORRECT phase III trial (RadioCORRECT study).

Objective: To identify imaging markers predicting clinical outcomes to regorafenib in metastatic colorectal carcinoma (mCRC).

Methods: The RadioCORRECT study is a post hoc analysis of a cohort of patients with mCRC treated within the phase III placebo-controlled CORRECT trial of regorafenib. Baseline and week 8 contrast-enhanced CT were used to assess response by RECIST 1.

A new tool for touch-free patient registration for robot-assisted intracranial surgery: application accuracy from a phantom study and a retrospective surgical series.

OBJECTIVE The purpose of this study was to compare the accuracy of Neurolocate frameless registration system and frame-based registration for robotic stereoelectroencephalography (SEEG). METHODS The authors performed a 40-trajectory phantom laboratory study and a 127-trajectory retrospective analysis of a surgical series. The laboratory study was aimed at testing the noninferiority of the Neurolocate system.

Lentiviral haemopoietic stem-cell gene therapy in early-onset metachromatic leukodystrophy: an ad-hoc analysis of a non-randomised, open-label, phase 1/2 trial.

Background: Metachromatic leukodystrophy (a deficiency of arylsulfatase A [ARSA]) is a fatal demyelinating lysosomal disease with no approved treatment. We aimed to assess the long-term outcomes in a cohort of patients with early-onset metachromatic leukodystrophy who underwent haemopoietic stem-cell gene therapy (HSC-GT).

Methods: This is an ad-hoc analysis of data from an ongoing, non-randomised, open-label, single-arm phase 1/2 trial, in which we enrolled patients with a molecular and biochemical diagnosis of metachromatic leukodystrophy (presymptomatic late-infantile or early-juvenile disease or early-symptomatic early-juvenile disease) at the Paediatric Clinical Research Unit, Ospedale San Raffaele, in Milan.

Shedding of clinical-grade lentiviral vectors is not detected in a gene therapy setting.

Gene therapy using viral vectors that stably integrate into ex vivo cultured cells holds great promises for the treatment of monogenic diseases as well as cancer. However, carry-over of infectious vector particles has been described to occur upon ex vivo transduction of target cells. This, in turn, may lead to inadvertent spreading of viral particles to off-target cells in vivo, raising concerns for potential adverse effects, such as toxicity of ectopic transgene expression, immunogenicity from in vivo transduced antigen-presenting cells and, possibly, gene transfer to germline cells.

Establishment of bone marrow and hematopoietic niches in vivo by reversion of chondrocyte differentiation of human bone marrow stromal cells.

Human bone marrow stromal cells (BMSCs, also known as bone marrow-derived "mesenchymal stem cells") can establish the hematopoietic microenvironment within heterotopic ossicles generated by transplantation at non-skeletal sites. Here we show that non-mineralized cartilage pellets formed by hBMSCs ex vivo generate complete ossicles upon heterotopic transplantation in the absence of exogenous scaffolds. These ossicles display a remarkable degree of architectural fidelity, showing that an exogenous conductive scaffold is not an absolute requirement for bone formation by transplanted BMSCs.