Compression in vasculitis

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How to Reduce Complexity in the Licensing Landscape of Standardised Technology

The innovation ecosystem is a fundamental driver of economic development and societal wellbeing. For this reason, key innovations such as 5G and IoT (Internet of Things), which are expected to bring significant benefits to our society and the world economy, should be supported by a standardization effort that allows different infrastructures, services and devices to interoperate in order to facilitate the diffusion and widespread deployment of new technologies on the market and avoid the risk of lock-in into competing, proprietary technologies. Standardization is fundamental to allow interoperability and the worldwide success of new technologies. Standardization bodies have the technical and administrative task to choose the best technology made available by innovators who participate in the standardization efforts. The latter are then rewarded for their contributions to standardization through patent licensing. However, with the ever-increasing complexity in technological standards, licensing activities are often quite complicated, and this causes friction between patent owners and implementers. The article proposes how to solve this complex situation, analysing the role of the FRAND commitment; which factors to be considered when setting a FRAND royalty rate; and how the different interests of innovators (patent owners/licensors) and implementers (licensees) should be well balanced, by means of patent pooling, or injunctions, thus promoting the level playing field that is at the core of fair market competition. This article offers insights from leading market participants who have engaged in licensing of standard essential patents, are developing frameworks to address the challenges of licensing of new technologies covering Internet of Things and application of cellular technologies in the automotive sector; and have actively litigated cases that help shape today’s negotiating process for SEPs. The first part of this article describes Europe’s ambitions in its Digital Agenda and sets out the Inventive Loop (a company’s R&D resulting in patented innovations that when standardised can be licensed for royalties that in turn fund further R&D). It then summarizes the exclusive right available to a patent owner, subject to compulsory licensing and to the holder’s FRAND promise if his innovation is essential to a standard. The article goes on to examines different methodologies for calculating a FRAND royalty rate and its application to new industrial sectors, such as through the adoption by automakers of new cellular mobility technologies. The final part of the article discusses two mechanisms to promote SEP licensing: the judicially created framework for SEP licensing negotiations (as recently set out in Sisvel v Haier) and in patent pools. It assesses a further recent judicial development – anti-suit injunctions – where the exercise of jurisdiction by one court may be harmful to the sovereignty of another. Alternative dispute resolution processes, such as arbitration, may provide a mechanism to resolve global FRAND licensing disputes and reduce these territorial conflicts. The article notes that standard setting organizations could serve as a platform to foster pool formation and to encourage arbitration

Efficacy of adalimumab for the treatment of refractory paediatric acrodermatitis continua of hallopeau

Acrodermatitis continua of Hallopeau (ACH) is a rare, chronic disease characterized by acropustular eruptions predominantly involving the distal phalanges of the hands and feet with marked involvement of the nail bed. The sterile pustules may coalesce to form groups of lesions, which, over time, may spread proximally to involve the dorsal side of the hands, forearms and feet. Pustulation of the nail bed and nail matrix are often associated with onychodystrophy and even anonychia of the involved digits. Atrophic skin changes, onychodystrophy and osteolysis are frequently present, causing painful and disabling lesions

Overview of Cell Death Mechanisms Induced by Rose Bengal Acetate-Photodynamic Therapy

Photodynamic Therapy (PDT) is a non-invasive treatment for different pathologies, cancer included, using three key components: non-toxic light-activated drug (Photosensitizer, PS), visible light, and oxygen. Their interaction triggers photochemical reactions leading to Reactive Oxygen Species (ROS) generation, that mediate cytotoxicity and cell death. In the present paper, the most important findings about the synthetic dye Rose Bengal Acetate (RBAc), an emerging photosensitizer for its efficient induction of cell death, will be reported with the aim to integrate RBAc phototoxicity to novel therapeutic PDT strategies against tumour cells. After its perinuclear intracellular localization, RBAc causes multiple subcellular organelles damage, that is, mitochondria, Endoplasmic Reticulum (ER), lysosomes, and Golgi complex. Indeed, RBAc exerts long-term phototoxicity through activation of both caspase-independent and- dependent apoptotic pathways and autophagic cell death. In particular, this latter cell death type may promote cell demise when apoptotic machinery is defective. The deep knowledge of RBAc photocytotoxicity will allow to better understand its potential photomedicine application in cancer

Buklet Potensi dan Peluang Investasi Berbahasa Mandarin di Dinas Penanaman Modal dan Pelayanan Terpadu Satu Pintu Banyumas

Laporan praktik kerja ini berjudul “Buklet Potensi dan Peluang Investasi Berbahasa Mandarin di Dinas Penanaman Modal dan Pelayanan Terpadu Satu Pintu Banyumas”. Kegiatan praktik kerja dilaksanakan selama enam bulan pada tanggal 15 Agustus 2022 hingga 11 Februari 2023 di Dinas Penanaman Modal dan Pelayanan Terpadu Satu Pintu (DPMPTSP) kabupaten Banyumas. Tujuan dilaksanakannya praktik kerja ini adalah untuk menghasilkan terjemahan buklet potensi dan peluang investasi Banyumas berbahasa Mandarin. Hal ini dilatar belakangi karena ada beberapa investor asing termasuk investor China yang menanamkan modalnya di Banyumas. Metode pengumpulan data yang penulis gunakan yaitu metode wawancara, metode studi pustaka, dan metode jelajah internet. Dalam proses penerjemahan, penulis menggunakan metode penerjemahan komunikatif. Dengan menggunakan metode komunikatif, hasil terjemahan disesuaikan dengan gramatikal Bahasa Sasaran (BSa). Selain menggunakan metode komunikatif, penulis juga menggunakan teknik penerjemahan deskripsi dalam proses penerjemahan, hal ini dilakukan untuk mendeskripsikan istilah budaya di dalam buklet yang tidak memiliki padanannya dalam BSa, sehingga calon investor China akan lebih mudah memahami isi dari buklet potensi dan peluang investasi kabupaten Banyumas. Hasil dari praktik kerja ini adalah buklet potensi dan peluang investasi Banyumas berbahasa Mandarin

Amelogenin, an extracellular matrix protein, in the treatment of venous leg ulcers and other hard-to-heal wounds: Experimental and clinical evidence

Amelogenins are extracellular matrix proteins that, under physiological conditions, self-assemble into globular aggregates up to micron-sizes. Studies with periodontal fibroblasts indicate that attachment to these structures increases the endogenous secretion of multiple growth factors and cell proliferation. Pre-clinical and clinical studies indicate that cutaneous wounds benefit from treatment with amelogenins. A randomized controlled trial (RCT) involving patients with hard-to-heal venous leg ulcers (VLUs) (ie, ulcers with a surface area ≥10 cm2 and duration of ≥6 months) showed that the application of amelogenin (Xelma®, Molnlycke Health Care, Gothenburg, Sweden) as an adjunct treatment to compression results in significant reduction in ulcer size, improvement in the state of ulcers, reduced pain, and a larger proportion of ulcers with low levels of exudate, compared with treatment with compression alone. Amelogenin therapy was also shown to be safe to use in that there were no significant differences in adverse events noted between patients treated with amelogenin plus compression and those treated with compression alone. Case study evaluations indicate that the benefits of amelogenin therapy demonstrated in the RCT are being repeated in “real life” situations and that amelogenin therapy may also have a role to play in the treatment of other wound types such as diabetic foot ulcers

EUREKA study - The evaluation of real-life use of a biophotonic system in chronic wound management: An interim analysis

Objective: Interest has grown regarding photobiomodulation (PBM) with low-level light therapy, which has been shown to positively affect the stages of the wound healing process. In a real-life context clinical setting, the objective of the EUREKA study was to investigate efficacy, safety, and quality of life associated with the use of a BioPhotonic gel (LumiHeal\u2122) in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs). This BioPhotonic gel represents a new, first-in-class emission spectrum of light, including fluorescence, to induce PBM and modulate healing. Design: The multicenter, prospective, interventional, uncontrolled, open-label study enrolled 100 patients in 12 wound centers in Italy. We performed an early interim analysis based on the first 33 subjects (13 VLU, 17 DFU, 3 PU) in seven centers who completed the study. Main results: Seventeen patients (52%) achieved total wound closure (full re-epithelialization for 2 weeks) during the study period. Two patients (6%) were considered \u201calmost closed\u201d (decrease of the wound area of more than 90% at study end) and three others (9%) were considered \u201cready for skin grafting\u201d. No related serious adverse events were observed, and the compliance was excellent. After the treatment, the average time to \u201cpain-free\u201d was 11.9 days in the VLU group. Quality of life was improved with overall increase of 26.4% of the total score (Cardiff Wound Impact Schedule, p=0.001). Conclusion: The study revealed a positive efficacy profile of the BioPhotonic gel in promoting wound healing and reactivating the healing process in different types of chronic, hard-to-heal wounds. The treatment was shown to be safe and well tolerated by the patients, and a reduction of pain perception was also detected during the treatment period. The improvement of the quality of life was accompanied by a high level of clinician satisfaction

Difficult-to-heal wounds of mixed arterial/venous and venous etiology: A cost-effectiveness analysis of extracellular matrix

Importance: Difficult-to-heal wounds pose clinical and economic challenges, and cost-effective treatment options are needed. Objective: The aim of this study is to determine the cost-effectiveness of extracellular matrix (ECM) relative to standard of care (SC) on wound closure for the treatment of mixed arterial/venous (A/V) or venous leg ulcers (VLUs). Design, setting, and participants: A two-stage Markov model was used to predict the expected costs and outcomes of wound closure for ECM and SC. Outcome data used in the analysis were taken from an 8-week randomized clinical trial that directly compared ECM and SC. Patients were followed up for an additional 6 months to assess wound closure. Forty-eight patients completed the study; 25 for ECM and 23 for SC. SC was defined as a standard moist wound dressing. Transition probabilities for the Markov states were estimated from the clinical trial. Main outcomes and measures: The economic outcome of interest was direct cost per closed-wound week. Resource utilization was based on the treatment regimen used in the clinical trial. Costs were derived from standard cost references. The payer’s perspective was taken. Results: ECM-treated wounds closed, on average, after 5.4 weeks of treatment, compared with 8.3 weeks for SC wounds (P=0.02). Furthermore, complete wound closure was significantly higher in patients treated with ECM (P<0.05), with 20 wounds closed in the ECM group (80%) and 15 wounds closed in the SC group (65%). After 8 months, patients treated with ECM had substantially higher closed-wound weeks compared with SC (26.0 weeks versus 22.0 weeks, respectively). Expected direct costs per patient were $2, 527 for ECM and$2, 540 for SC (a cost savings of $13). Conclusion and relevance: ECM yielded better clinical outcomes at a slightly lower cost in patients with mixed A/V and VLUs. ECM is an effective treatment for wound healing and should be considered for use in the management of mixed A/V and VLUs

Visual telerehabilitation in the Covid-19 era: tradition meets innovation

[EN] Visual telerehabilitation is crucial to rise to the challenges of Covid-19 in order to advocate impaired individuals’ adaptation and social inclusion. The present research aims at detecting the predictors of the visual telerehabilitation protocol’s best outcome, also exploring variables’ interactions. The protocol by Chiossone Institute (Italy, Genoa) was administered in 2020 (March-May). Patients weekly video-called the orthoptists (by tablet or PC) to follow a personalized program on residual vision and diagnosis. The sample included seventy-five visually impaired individuals, across different age ranges (n=46 children and n=29 adults), who had all begun in person rehabilitation before pandemic. To detect the predictors of visual telerehabilitation effectiveness, orthoptists completed a self-report sheet with evaluation of the reaction time, participants socio-demographical data, diagnosis, residual vision, telematic session time-length, compliance level.  Descriptive, linear regression, and moderation analyses were implemented. Children’s reaction time was predicted by age, sessions’ time-length, and compliance. Adults’ reaction time was predicted by sessions’ time length, without significant moderators. These findings encourage the combination of traditional setting elements and technological innovation.Perasso, G.; Baghino, C.; Capris, E.; Cocchi, E.; Dini, S.; Facchini, V.; Panizzi, A.... (2022). Visual telerehabilitation in the Covid-19 era: tradition meets innovation. En Proceedings INNODOCT/21. International Conference on Innovation, Documentation and Education. Editorial Universitat Politècnica de València. 41-48. https://doi.org/10.4995/INN2021.2021.13321OCS414

Clinical evaluation of the efficacy and safety of a medical device in various forms containing Triticum vulgare for the treatment of venous leg ulcers – A randomized pilot study

This study was carried out to assess the efficacy and tolerability of the topical application of an aqueous extract of Triticum vulgare (TV) in different vehicles (cream, impregnated gauzes, foam, hydrogel, and dressing gel) for the treatment of venous lower leg ulcers. Fifty patients were randomized to receive one of the five investigational vehicles. Treatment was performed up to complete healing or to a maximum of 29 days. The wound size reduction from baseline was the primary efficacy variable, which was measured by means of a noninvasive laser scanner instrument for wound assessment. In all groups, apart from the foam group, a similar trend toward the reduction of the surface area was observed. The cream showed the greatest effect on the mean reduction of the lesion size. At last visit, six ulcers were healed: two in the cream group, three in the gauze group, and one in the dressing gel group. In the patients treated with the cream, the gauzes, the hydrogel, and the dressing gel, the reduction of lesion size was 40%–50%; the reduction was smaller in the foam group. No impact in terms of age on the healing process was found. The Total Symptoms Score decreased in all groups during the study; a greater efficacy in terms of signs/symptoms was observed in the patients treated with the gauzes. In the dressing gel group, one patient had an infection of the wound after 3 weeks of treatment and 2 of colonization, leading to a systemic antibiotic treatment. The events were judged as nonrelated to the device used. On the basis of the results, it could be argued that the medical device may be useful in the treatment of chronic venous ulcer