Impact of coronavirus disease 2019 pandemic on good clinical practice trials in oncology.

Aim: Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population, so many recommendations have been approved to ensure optimal management. Clinical research was notably impacted by COVID too. This review aims to analyze the challenges occurred during a pandemic for the management of enrolled patients (enrollment, use of telemedicine visits, study procedures) and for the clinical trials system (from feasibility to selection visit, site initiation visit, monitorings, use of e-signature, deviations and discontinuations). Methods: The studies included in the present review were selected from PubMed/Google Scholar/ScienceDirect databases. Results: During the first phase of pandemic many clinical trials were suspended in accrual and, as the pandemic progressed, recommendations were established to guarantee the safety and the continuity of care of enrolled patients. In addition, lot of new strategies was found during the pandemic to reduce the negative consequences on clinical trial performance and to guarantee new opportunities of care in the respect of good clinical practice (GCP) in a bad scenario. Conclusions: Among all modifiers, investigators would prefer to maintain the positive ones such as pragmatic and simplified trial designs and protocols, reducing in-person visits when not necessary and to minimizing sponsor and contract research organizations (CROs) visits.

UV-B Irradiation Effect on Microalgae Performance in the Remediation of Effluent Derived from the Cigarette Butt Cleaning Process.

In this study, the potential of ultraviolet B (UV-B) radiation to alleviate the effects of pollutants in cigarette butt wastewater (CBW) was investigated using different Chlorella sorokiniana strains (F4, R1 and LG1). Microalgae were treated with UV-B (1.7 W m-2) for 3 days prior to their exposure to CBW and then incubated for 4 days in the absence or presence of UV-B. UV-B-untreated microalgae were used as the control. Comparative physiological responses, including photosynthetic pigments and non-enzymatic antioxidants, as well as nicotine and nicotyrine removal, were evaluated in 7-day cultures. UV-B treatments did not negatively impact algal chlorophyll or carotenoid production. UV-B acclimation was strain-dependent, correlating with native environment adaptations and genetic constitutions. UV-B as a pretreatment had long-term positive effects on non-enzymatic antioxidant capacity. However, LG1 needed more time to readjust the pro-oxidant/antioxidant balance, as it was the most UV-B-sensitive. Phenolic compounds played an important role in the antioxidant system response to UV-B, while flavonoids did not contribute to the total antioxidant capacity. Although cross-resistance between UV-B and CBW was observed in F4 and R1, only R1 showed nicotine/nicotyrine catabolism induction due to UV-B. Overall, the results suggest that UV-B activates defense pathways associated with resistance or tolerance to nicotine and nicotyrine.

Remediation Capacity of Different Microalgae in Effluents Derived from the Cigarette Butt Cleaning Process.

Microalgal-based remediation is an ecofriendly and cost-effective system for wastewater treatment. This study evaluated the capacity of microalgae in the remediation of wastewater from cleaning process of smoked cigarette butts (CB). At laboratory scale, six strains (one from the family Scenedesmaceae, two Chlamydomonas debaryana and three Chlorella sorokiniana) were exposed to different CB wastewater dilutions to identify toxicity levels reflected in the alteration of microalgal physiological status and to determine the optimal conditions for an effective removal of contaminants. CB wastewater could impact on microalgal chlorophyll and carotenoid production in a concentration-dependent manner. Moreover, the resistance and remediation capacity did not only depend on the microalgal strain, but also on the chemical characteristics of the organic pollutants. In detail, nicotine was the most resistant pollutant to removal by the microalgae tested and its low removal correlated with the inhibition of photosynthetic pigments affecting microalgal growth. Concerning the optimal conditions for an effective bioremediation, this study demonstrated that the Chlamydomonas strain named F2 showed the best removal capacity to organic pollutants at 5% CB wastewater (corresponding to 25 butts L−1 or 5 g CB L−1) maintaining its growth and photosynthetic pigments at control levels.

Photosynthesizing while hyperaccumulating nickel: Insights from the genus Odontarrhena (Brassicaceae).

Nickel-induced changes in photosynthetic activity were investigated in three Ni-hyperaccumulating Odontarrhena species with increasing Ni tolerance and accumulation capacity, O. muralis, O. moravensis, and O. chalcidica. Plantlets were grown in hydroponics at increasing NiSO4 concentrations (0, 0.25, and 1 mM) for one week, and the effects of Ni on growth, metal accumulation, photosynthesis, and nitrogen (N) allocation to components of the photosynthetic apparatus were analysed. Nickel treatments in O. chalcidica, and O. moravensis to a lesser extent, increased not only the photochemical efficiency of photosystem II (PSII) and the CO2 assimilation rate, but also CO2 diffusion from the atmosphere to the carboxylation sites. These two species displayed a specific increase and/or rearrangement of the photosynthetic pigments and a higher leaf N allocation to the photosynthetic components in the presence of the metal. Odontarrhena muralis displayed a decrease in photosynthetic performance at the lowest Ni concentration due to a combination of both stomatal and non-stomatal limitations. Our data represent the first complete investigation of the effects of Ni on the photosynthetic machinery in Ni hyperaccumulating plants. Our findings clearly indicate a stimulatory, hormetic-like, effect of the metal on both biophysics and biochemistry of photosynthesis in the species with the highest hyperaccumulation capacity.

Ulva intestinalis Extract Acts as Biostimulant and Modulates Metabolites and Hormone Balance in Basil (Ocimum basilicum L.) and Parsley (Petroselinum crispum L.).

Natural elicitors from macroalgae may affect plant secondary metabolites. Ulvan is a sulfated heteropolysaccharide extracted from green seaweed, acting as both a plant biotic protecting agent, and a plant elicitor, leading to the synthesis of signal molecules. In this work, the aqueous extract of Ulva intestinalis L., mainly composed of ulvan, was used as foliar-spraying treatment and its eliciting effect was investigated in basil (Ocimum basilicum L.) and parsley (Petroselinum crispum L.). Antioxidant metabolites (polyphenols and carotenoids), volatile compounds (both in headspace emissions and hydrodistilled essential oils), and hormones (jasmonic acid, salicylic acid, salicylic acid 2-O-ß-D-glucoside, abscisic acid, and azelaic acid) were quantified. The foliar-spraying treatment with U. intestinalis extract increased salicylic acid and its ß-glucoside in parsley; in basil, it induced the accumulation of jasmonic and abscisic acids, indicating the presence of a priming effect. In basil, the elicitation caused a change of the essential oil (EO) chemotype from methyl eugenol/eugenol to epi-α-cadinol and increased sesquiterpenes. In parsley EO it caused a significant accumulation of 1,3,8-p-menthatriene, responsible of the typical "parsley-like" smell. In both species, the phenylpropanoids decreased in headspace and EO compositions, while the salicylic acid concentration increased; this could indicate a primarily defensive response to U. intestinalis extract. Due to the evidenced significant biological activity, U. intestinalis extract used as an elicitor may represent a suitable tool to obtain higher amounts of metabolites for optimizing plant flavor metabolites.

Correction: Effect of Iodine treatments on Ocimum basilicum L.: Biofortification, phenolics production and essential oil composition.

[This corrects the article DOI: 10.1371/journal.pone.0226559.].

Hormone profile changes occur in roots and leaves of Micro-Tom tomato plants when exposing the aerial part to low doses of UV-B radiation.

During the last decades, many studies investigated the effects of UV-B on the above-ground organs of plants, directly reached by the radiation but, to the best of our knowledges, the influence of mild UV-B doses on root hormones was not explored. Consequently, this research aimed at understanding whether low, not-stressful doses of UV-B radiation applied above-ground influenced the hormone concentrations in leaves and roots of Micro-Tom tomato (Solanum lycopersicum L.) plants during 11 days of treatment and after 3 days of recovery. In particular, ethylene, abscisic acid, jasmonic acid, salicylic acid and indoleacetic acid were investigated. The unchanged levels of chlorophyll a and b, lutein, total xanthophylls and carotenoids, as well as the similar H2O2 concentration between control and treated groups suggest that the UV-B dose applied was well tolerated by the plants. Leaf ethylene emission decreased after 8 and 11 days of irradiation, while no effect was found in roots. Conversely, indoleacetic acid underwent a significant reduction in both organs, though in the roots the decrease occurred only at the end of the recovery period. Salicylic acid increased transiently in both leaves and roots on day 8. Changes in leaf and root hormone levels induced by UV-B radiation were not accompanied by marked alterations of plant architecture. The results show that irradiation of above-ground organs with low UV-B doses can affect the hormone concentrations also in roots, with likely implications in stress and acclimation responses mediated by these signal molecules.

Effect of Iodine treatments on Ocimum basilicum L.: Biofortification, phenolics production and essential oil composition.

Iodine biofortification has been gaining interest in recent years as a sustainable and innovative approach to eradicate iodine deficiency disorders. Studying the impact of iodine biofortification on plant phenotype, biochemical and physiological parameters is crucial to leverage the expertise and best practices for the agro-food industry and human health. The aim of this study was to evaluate iodine biofortification on the main quantitative and qualitative traits of basil (Ocimum basilicum L.) plants cultivated both in open field and in growth chamber. The impact of KI and KIO3 treatments was evaluated on biomass production, as well as on the synthesis of phenolic compounds, especially rosmarinic acid and other caffeic acid derivatives, and on the essential oil (EO) composition. These compounds are typically accumulated in basil leaves and strongly contribute to the plant nutraceutical value and aroma. In open field, the use of increasing concentrations of both iodine salts gradually enhanced iodine accumulation in leaves, also determining an increase of the antioxidant power, total phenolics, rosmarinic acid and cinnamic acid accumulation. The composition of EO was only slightly affected by the treatments, as all the samples were characterized by a linalool chemotype and a minor alteration in their relative content was observed. A growth chamber experiment was performed to test EO variation in controlled conditions, broadening the range of iodine concentrations. In this case, plant chemotype was significantly affected by the treatments and large EO variability was observed, suggesting that iodine form and concentration can potentially influence the EO composition but that in open field this effect is overcome by environmental factors.

Influence of partial replacement of soya bean meal by faba beans or peas in heavy pigs diet on meat quality, residual anti-nutritional factors and phytoestrogen content.

The study evaluated the partial substitution of soybean meal by faba beans (18%) or peas (20%) as additional protein sources in diets destined for typical Italian heavy pig production. It compared animal performances, meat quality, the presence of residual anti-nutritional factors (ANF) and phytoestrogens in plasma and meat and the possible effects on pig health, by evaluating oxidative, inflammatory and pro-atherogenic markers. The results showed that the productive performances, expressed as body weight and feed conversion ratio, of pigs fed with faba bean and pea diets were similar to those of pigs fed only the soybean meal. Meat quality of pigs fed with the three diets was similar in colour, water-holding capacity, tenderness and chemical composition. Despite the higher levels of phytoestrogen in the plasma of pigs fed only the soybean meal, phytoestrogen concentration in the muscle was equivalent to that of animals fed diets with faba beans, whereas pigs fed a diet with peas showed a lower concentration. Inflammation and pro-atherogenic parameters did not show significant differences among the three diets. Overall, the partial substitution of soybean meal by faba beans appears more interesting than with peas, particularly in relation to the higher amount of polyphenols in the diet and the highest concentration of phytoestrogens found in the plasma and muscle of animals, while the pyrimidine anti-nutritional compounds present in the diet did not appear to accumulate and had no effect on the growth performance of animals.

Ethylene produced by the endosperm is involved in the regulation of nucellus programmed cell death in Sechium edule Sw.

The nucellus is a maternal tissue that feeds the developing embryo and the secondary endosperm. During seed development the cells of the nucellus suffer a degenerative process early after fertilization as the cellular endosperm expands and accumulates reserves. Nucellar cell degeneration has been characterized as a form of developmentally programmed cell death (PCD). In this work we analysed the role of the endosperm as main regulator of nucellus PCD. We demonstrated that endosperm produces high amount of ethylene, nitric oxide and indoleacetic acid. We examined the role of these small and diffusible signalling molecules in the regulation of nucellus PCD and we tried to elucidate how they can cooperate and regulate each other into the endosperm. We showed that ethylene acts a positive regulator of nucellus PCD and its synthesis can be in part induced by nitric oxide. High levels of IAA were detected both in the endosperm and in dying nucellus but this hormone is not directly involved in the execution of PCD.