clinical trial

High-Dose intravenous immunoglobulin is effective in painful diabetic polyneuropathy resistant to conventional treatments. Results of a double-blind, randomized, placebo-controlled, multicenter trial

Objectives: The efficacy and safety of high-dose intravenous immunoglobulin (IVIG) in treatment-resistant diabetic painful polyneuropathy (DPN) were assessed. Design: This was a randomized, double-blind, placebo-controlled, multicenter trial (EudraCT 2010-023883-42). Setting: This trial was conducted at eight sites in Italy with a neurology specialist level of care.

Antiviral activity of reagents in mouth rinses against SARS-CoV-2

The oral cavity, an essential part of the upper aerodigestive tract, is believed to play an important role in the pathogenicity and transmission of SARS-CoV-2. The identification of targeted antiviral mouth rinses to reduce salivary viral load would contribute to reducing the COVID-19 pandemic. While awaiting the results of significant clinical studies, which to date do not exist, the commercial availability of mouth rinses leads us to search among them for reagents that would have specific antiviral properties with respect to SARS-CoV-2.

Effect of recombinant human nerve growth factor eye drops in patients with dry eye: a phase IIa, open label, multiple-dose study

Background: Dry eye disease (DED) affects more than 14% of the elderly population causing decrease of quality of life, high costs and vision impairment. Current treatments for DED aim at lubricating and controlling inflammation of the ocular surface. Development of novel therapies targeting different pathogenic mechanisms is sought-after. The aim of this study is to evaluate safety and efficacy of recombinant human nerve growth factor (rhNGF) eye drops in patients with DED.

Yoga and mindfulness as a tool for influencing affectivity, anxiety, mental health, and stress among healthcare workers. Results of a single-arm clinical trial

Mindfulness-based interventions have emerged as unique approaches for addressing a range of clinical and subclinical difficulties such as stress, chronic pain, anxiety, or recurrent depression. Moreover, there is strong evidence about the positive effects of yoga practice on stress management and prevention of burnout among healthcare workers. The aim of this study was to conduct a single-arm clinical trial to assess the effectiveness of an intervention based on mindfulness-based stress reduction and yoga in improving healthcare workers' quality of life.

Efficacy of two different doses of rabbit anti-T-lymphocyte globulin to prevent graft-versus-host disease in children with haematological malignancies transplanted from an unrelated donor: a multicentre, randomised, open-label, phase 3 trial

Background Although rabbit anti-T-lymphocyte globulin (ATLG) is largely used for the prevention of immune-mediated complications in patients given allogeneic haemopoietic stem-cell transplantation (HSCT) from an unrelated donor, the optimum dose of this drug in children is still undefined. We aimed to test whether a higher dose of ATLG was superior to a lower dose for prevention of grade II–IV acute graft-versus-host disease (GVHD).

Two-year longitudinal monitoring of amnestic mild cognitive impairment patients with prodromal alzheimer's disease using topographical biomarkers derived from functional magnetic resonance imaging and electroencephalographic activity

Auditory "oddball" event-related potentials (aoERPs), resting state functional magnetic resonance imaging (rsfMRI) connectivity, and electroencephalographic (rsEEG) rhythms were tested as longitudinal functional biomarkers of prodromal Alzheimer's disease (AD). Data were collected at baseline and four follow-ups at 6, 12, 18, and 24 months in amnesic mild cognitive impairment (aMCI) patients classified in two groups: "positive" (i.e., "prodromal AD"; n = 81) or "negative" (n = 63) based on a diagnostic marker of AD derived from cerebrospinal samples (Aβ42/P-tau ratio).

Biomarker matrix to track short term disease progression in amnestic mild cognitive impairment patients with prodromal Alzheimer's disease

BACKGROUND: Assessment of human brain atrophy in temporal regions using magnetic resonance imaging (MRI), resting state functional MRI connectivity in the left parietal cortex, and limbic electroencephalographic (rsEEG) rhythms as well as plasma amyloid peptide 42 (Aβ42) has shown that each is a promising biomarker of disease progression in amnestic mild cognitive impairment (aMCI) patients with prodromal Alzheimer's disease (AD). However, the value of their combined use is unknown.

Plasma Aβ42 as biomarker of prodromal Alzheimer's disease progression in patients with amnestic mild cognitive impairment: evidence from the pharmaCog/E-ADNI study

It is an open issue whether blood biomarkers serve to diagnose Alzheimer's disease (AD) or monitor its progression over time from prodromal stages. Here, we addressed this question starting from data of the European FP7 IMI-PharmaCog/E-ADNI longitudinal study in amnesic mild cognitive impairment (aMCI) patients including biological, clinical, neuropsychological (e.g., ADAS-Cog13), neuroimaging, and electroencephalographic measures.

Predicting and tracking short term disease progression in amnestic mild cognitive impairment patients with prodromal alzheimer's disease: structural brain biomarkers

BACKGROUND:
Early Alzheimer's disease (AD) detection using cerebrospinal fluid (CSF) biomarkers has been recommended as enrichment strategy for trials involving mild cognitive impairment (MCI) patients.

OBJECTIVE:
To model a prodromal AD trial for identifying MRI structural biomarkers to improve subject selection and to be used as surrogate outcomes of disease progression.

Random Projection to Preserve Patient Privacy

With the availability of accessible and widely used cloud services, it is natural that large components of healthcare systems migrate to them; for example, patient databases can be stored and processed in the cloud. Such cloud services provide enhanced flexibility and additional gains, such as availability, ease of data share, and so on. This trend poses serious threats regarding the privacy of the patients and the trust that an individual must put into the healthcare system itself. Thus, there is a strong need of privacy preservation, achieved through a variety of different approaches.

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