TRY plant trait database – enhanced coverage and open access

Plant traits - the morphological, anatomical, physiological, biochemical and phenological characteristics of plants - determine how plants respond to environmental factors, affect other trophic levels, and influence ecosystem properties and their benefits and detriments to people. Plant trait data thus represent the basis for a vast area of research spanning from evolutionary biology, community and functional ecology, to biodiversity conservation, ecosystem and landscape management, restoration, biogeography and earth system modelling. Since its foundation in 2007, the TRY database of plant traits has grown continuously. It now provides unprecedented data coverage under an open access data policy and is the main plant trait database used by the research community worldwide. Increasingly, the TRY database also supports new frontiers of trait‐based plant research, including the identification of data gaps and the subsequent mobilization or measurement of new data. To support this development, in this article we evaluate the extent of the trait data compiled in TRY and analyse emerging patterns of data coverage and representativeness. Best species coverage is achieved for categorical traits - almost complete coverage for ‘plant growth form’. However, most traits relevant for ecology and vegetation modelling are characterized by continuous intraspecific variation and trait–environmental relationships. These traits have to be measured on individual plants in their respective environment. Despite unprecedented data coverage, we observe a humbling lack of completeness and representativeness of these continuous traits in many aspects. We, therefore, conclude that reducing data gaps and biases in the TRY database remains a key challenge and requires a coordinated approach to data mobilization and trait measurements. This can only be achieved in collaboration with other initiatives

Plant–environment interactions through a functional traits perspective: a review of Italian studies

Italy is among the European countries with the greatest plant diversity due to both a great environmental heterogeneity and a long history of man–environment interactions. Trait-based approaches to ecological studies have developed greatly over recent decades worldwide, although several issues concerning the relationships between plant functional traits and the environment still lack sufficient empirical evaluation. To draw insights on the association between plant functional traits and direct and indirect human and natural pressures on the environmental drivers, this article summarizes the existing knowledge on this topic by reviewing the results of studies performed in Italy adopting a functional trait approach on vascular plants, bryophytes and lichens. Although we recorded trait measurements for 1418 taxa, our review highlighted some major gaps in plant traits knowledge: Mediterranean ecosystems are poorly represented; traits related to belowground organs are still overlooked; traits measurements for bryophytes and lichens are lacking. Finally, intraspecific variation has been little studied at community level so far. We conclude by highlighting the need for approaches evaluating trait–environment relationship at large spatial and temporal scales and the need of a more effective contribution to online databases to tie more firmly Italian researchers to international scientific networks on plant traits

Postsurgical adjuvant therapy for melanoma - Evaluation of a 3-year randomized trial with recombinant interferon-alpha after 3 and 5 years of follow-up

BACKGROUND, Early surgical intervention is still the most successful therapy for patients with melanoma. The results obtained with medical therapies are still quite disappointing, with better results observed in soft tissue and lymph node metastasis. There currently is no standardized adjuvant therapy for primary melanoma. On the basis of the activity demonstrated in vitro against melanoma cell lines and the results obtained in many clinical trials in patients with advanced melanoma, the authors chose to study the use of recombinant interferon-alpha (IFN-alpha) as adjuvant therapy for patients with Stage I and Stage II melanoma. METHODS, A randomized multicenter trial based on the use of recombinant IFN-alpha-2b for 3 years at the dose of 3 MU given intramuscularly 3 times a week for a period of 6 months with a 1-month interval between cycles was conducted in Stage I and Stage II melanoma patients (using the American Joint Committee on Cancer classification). The efficacy of this treatment was evaluated calculating the incidence of recurrence after 3 and 5 years. RESULTS, Results were collected at the end of the treatment period and after 5 years of follow-up for a smaller number of patients. Statistical evaluation showed a significant difference between treated patients and untreated controls with regard to progression of the disease. In particular, IfN-alpha appears to be more effective in patients with worse prognosis lesions. CONCLUSIONS. IFN-alpha appears to be effective as adjuvant therapy for high risk melanoma patients and the risk/benefit ratio appears to be very favorable. The authors' next goal is to separate those patients who might benefit from adjuvant therapy from those who are cured after the surgical intervention only. (C) 1997 American Cancer Society

Clinical Trials and Machine Learning: Regulatory Approach Review

Machine Learning, a fast-growing technology, is an application of Artificial Intelligence that has provided important contributes to drug discovery and clinical development. In the last few years, the number of clinical applications based on Machine Learning has been constantly growing and this is now affecting the National Competent Authorities during the assessment of most recently submitted Clinical Trials that are designed, managed or that are generating data deriving from the use of Machine Learning or Artificial Intelligence technologies. We review current information available on the regulatory approach to Clinical Trials and Machine Learning. We also provide inputs for further reasoning and potential indications, including six actionable proposals for regulators to proactively drive the upcoming evolution of Clinical Trials within a strong regulatory frame-work, focusing on patient's safety, health protection and fostering immediate access to effective treatments

Moving towards a customized approach for drug development: lessons from clinical trials with immune checkpoint inhibitors in lung cancer

Lung cancer has recently been discovered to be an immunological targetable disease, on the basis of the exciting results of the randomized trials with immune checkpoint inhibitors. Nevertheless, the survival benefit appears to not be entirely captured by the usual outcome measures, thus requiring a deep reflection about the appropriateness of the traditional statistical methodologies in this context. The intrinsic biological differences existing both in terms of mechanism of action and kinetic between immunotherapy and chemotherapy or targeted therapy, impact on patients' outcome, requiring a global revolution in the way to design clinical studies with the ideal aim to evolve towards trials carefully 'customized' on the basis of the investigational drug, the specific disease and the biological background. The exciting data recently obtained with immune checkpoint inhibitors, offer an ideal context and background to explore the major questions and future perspectives about the development of immunotherapeutic agents. In this regard, the choice of adequate endpoints, the use of modified statistical methods and the potential introduction of predictive biomarkers for immunotherapy clinical trials, will be discuss in this review in order to provide practical and rationale suggestions aimed to improve the existing model for cancer immunotherapy investigation

Evaluación de la disponibilidad del hierro para la eritropoyesis en una población tratada por hemodiálisis crónica

En la hemodiálisis crónica (HDC), determinar el hierro disponible para la eritropoyesis implica algunos desafíos. La ferritina y la saturación de transferrina (SatT) tienen limitaciones. El porcentaje de eritrocitos hipocrómicos (%Hypo) y contenido de hemoglobina reticulocitaria (CHr) se consideran indicadores directos del hierro utilizable. Objetivo: Evaluar el hierro disponible mediante CHr y %Hypo y analizar su relación con parámetros habituales, inflamación y respuesta a la eritropoyetina (Epo). Material y métodos: Estudio observacional y transversal en 80 pacientes con HDC, sin sangrado evidente, infección u operación reciente, neoplasia o talasemia; 64 pacientes recibían Epo. Se determinaron hemoglobina, %Hypo, reticulocitos, CHr, sideremia, ferritina, transferrina y proteína C reactiva (PCR), expresados por mediana y percentiles 2.5 - 97.5. Índice de resistencia a Epo (ResistEpo) = (dosis/kg/sem)/hemoglobina. Resultados: La población presentaba hemoglobina =11.8 g/dl (9.2-14.2), sideremia = 54.6 μg/dl (21-111), SatT = 21.3% (9.3-47.5), %Hypo = 1.4% (0.1-7.1), CHr = 32.4 pg (27.5-35), ferritina = 422 ng/ml (26-1,396), PCR = 9.5 mg/L (0.5-91.7). Sideremia y SatT se correlacionaron positivamente con %Hypo y negativamente con CHr (p 10 mg/L determinaron el riesgo de %Hypo > 3%. Sideremia, SatT ≤ 20% y %Hypo explicaron la ResistEpo > 12, desde %Hypo >3% (OR = 5.26; p = 0.03). Conclusiones: %Hypo y CHr complementan la evaluación del hierro en HDC. Se confirmó una relación entre inflamación y hierro disponible. %Hypo > 3% es el determinante de respuesta a Epo

The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience

This study aimed to assess the real-life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within the Italian compassionate use program