Evaluation of Biosecurity Measures in Pig Holdings in Slovenia as a Risk Assessment for the Introduction of African Swine Fever Virus.

African Swine Fever (ASF) is persistently spreading and hindering pork production in Europe. Slovenia is one of the last countries in Central Europe without a confirmed ASF case in domestic pigs or in wild boar. The aim of this study was to assess the current biosecurity implementation on different types of pig farms. Internal and external biosecurity status was determined in 17 commercial (CF), 15 non-commercial (NC), and 15 outdoor (O) farms. Data were collected using the Biocheck.UGent questionnaire and assessed in combination with the latest information on the wild boar population in Slovenia. Biosecurity was compared between farm types based on the assessment of 12 subcategories. Statistically significant differences (p < 0.05) were found in six subcategories: (i) purchase of pigs and semen, (ii) visitors and farmworkers, (iii) vermin and bird control, (iv) finishing unit, (v) measures between compartments and use of equipment, and (vi) cleaning and disinfection. The highest total biosecurity score (0-100%) was determined on CF with 64.59 ± 16.47%, followed by NC with 55.73 ± 10.67%, and O with 48.47 ± 8.20%. The density of the wild boar population was estimated from the number of wild boars per km2 per year, with 3 or more hunted wild boars per unit representing the highest density. Geolocation of farms on the wild boar population map showed that two O farms are at high risk and seven farms (1 O, 5 NC, and 1 CF) are at medium risk for disease transmission from wild to domestic pigs. Biosecurity measures must be tightened in some subcategories, especially in areas with a high density of wild boar.

The levels of oxidative stress in a combination of stress factors.

We studied the effect of the combined action of ionizing radiation and induced immobilization stress on the lipid peroxidation process and antioxidant protection of organs (mesenteric lymph nodes, spleen, adrenal glands, thymus, and liver) and immune cels - the blood lymphocytes. Results were obtained on the role of free-radical oxidation in combination with exposure to ionizing radiation and immobilization stress at an early stage in the experiment. Gamma radiation in the acute period resulted in significant changes in lipoperoxidation and antioxidant systems. The first period of immobilization stress was marked by the imbalance of LPO-AOS systems disturbance with an accumulation of toxic compounds in tissues which had affected their function. The combined sublethal gamma radiation and immobilization stress disturbed the functional activity of adaptive systems of the body in the early stage of adaptation syndrome. Furthermore, the results show the dominant role of ionizing radiation in it.

The role of non-commercial cyprinids in maintenance and spread of the opisthorchiasis focus in the middle Ob River basin (Tomsk region, Russia).

The study assessed the role of non-commercial cyprinid species in maintaining the opisthorchiasis focus in the middle Ob River basin, Tomsk region, Russia. The source of O. felineus infection for humans and carnivores is fish of the family Cyprinidae. This is the most numerous family, 14 species live in the middle Ob River basin, which includes 6 commercial species and 8 non-commercial species. This study aimed to investigate the current situation on infestation of non-commercial cyprinids with O. felineus metacercariae and their role in maintaining and spreading the natural focus of opisthorchiasis in the middle Ob River basin. We investigated 4 non-commercial species (tench, sunbleak, common bleak, gudgeon), which are highly abundant in water bodies. Tench, common bleak and gudgeon are objects of amateur fishing. These species are traditionally included in the diet of the local population. Opisthorchis felineus metacercariae were recorded in muscles of all the examined fish species. The identification of metacercariae was confirmed by morphological methods and PCR diagnostics. Tench and sunbleak are the main sources of opisthorchiasis infection in the floodplain lakes of the Ob River basin (the prevalence of tench infection is 89.3% and mean intensity of infection is 11.2 metacercariae per fish, the prevalence of sunbleak infection is 50.9% and the intensity of infection is 4.25 metacercariae per fish). The prevalence of infection in the introduced common bleak from the rivers of the middle Ob River basin is rapidly increasing from 2.4 (2016-2018) to 37.5% (2020-2021), and mean intensity of infection increased from 1 to 4.15. The epizootic state of water bodies in the middle Ob River basin remains unfavorable in relation to opisthorchiasis. Tench, common bleak and sunbleak, along with ide and dace, are the main source of infection for humans and animals, which is evidenced by high infection with Opisthorchis felineus metacercariae in these numerous fish species. They pose the greatest danger of infection of people and animals with opisthorchiasis. These species should be included in the campaign to avoid raw and poorly cooked fish in the diet. In addition, such species as roach, bream and sunbleak also pose the danger of infection with opisthorchiasis, but to a lesser extent.

European non-commercial sponsors showed substantial variation in results reporting to the EU trial registry.

OBJECTIVE: To describe the trial results reporting behavior of leading European non-commercial sponsors by country and over time. STUDY DESIGN AND SETTING: Cross-sectional analysis describing results reporting rates to the European Clinical Trials Registry among the top sponsors across Europe as of May 2021 and a comparison of reporting trends for a cohort of major sponsors between January 2018 and May 2021. RESULTS: Fifty-nine highly active sponsors from 10 countries and 9 collaborative groups had 1,916 trials due to report, representing 14% of all due trials on the registry (n = 13,709); of these, 1,058 had reported results (55.2%). Sponsors in the UK, Belgium and Germany had the highest compliance at 94%, 69% and 58%; those in Spain, France and the Netherlands, had the lowest, ranging from 4% to 21%. Collaborative groups had a reporting rate of 50%. In the major sponsors cohort (n = 49), those with no reporting to the registry decreased from 27 (55%) in 2018 to 10 (20%) in 2021. Thirteen of these sponsors (27%) reached a 90-100% reporting rate in 2021 compared to 0 in 2018. CONCLUSION: Compliance with EU regulations by non-commercial sponsors is highly variable between countries. Enforcement of EU reporting regulations should be prioritized.

Which factors contribute to road crashes in non-commercial and commercial vehicles? An examination of administrative data from motorways in Pakistan.

This study aimed to exhibit the crash distribution and compare the contributory factors (crash characteristics, driver characteristics, vehicle characteristics and road characteristics) responsible for road crashes between non-commercial and commercial vehicles. To achieve the objective, a step-wise binary logistic regression (LR) model was employed with the forward LR method to explore the contributing factors to road crashes between the non-commercial and commercial vehicles. The road crash data (2013-2017) on motorways (M1 and M2) was collected from the National Highway and Motorway Police (NHMP) in Pakistan. During the study period, a total of 1110 road crashes were recorded. The proportion of fatal and non-fatal crashes were 29% and 71% for non-commercial vehicles and 31% and 69% for commercial vehicles, respectively. The results from LR model revealed that drowsy driving, poor road conditions, overspeeding and tire bursting were found to be significant predictors of road crashes. Road crashes caused by drowsy driving and poor vehicle condition were prevalent in commercial vehicles. On the contrary, overspeeding and tire bursting were more prevalent in non-commercial vehicles. The remaining factors could not achieve significant values in the model. On the basis of these empirical findings, suggestions to improve safety were pointed out.

Non-commercial pharmaceutical R&D: what do neglected diseases suggest about costs and efficiency?

Background: The past two decades have witnessed significant growth in non-commercial research and development (R&D) initiatives, particularly for neglected diseases, but there is limited understanding of the ways in which they compare with commercial R&D. This study analyses costs, timelines, and attrition rates of non-commercial R&D across multiple initiatives and how they compare to commercial R&D. Methods: This is a mixed-method, observational, descriptive, and analytic study. We contacted 48 non-commercial R&D initiatives and received either quantitative and/or qualitative data from 13 organizations. We used the Portfolio to Impact (P2I) model's estimates of average costs, timelines, and attrition rates for commercial R&D, while noting that P2I cost estimates are far lower than some previous findings in the literature. Results: The quantitative data suggested that the costs and timelines per candidate per phase (from preclinical through Phase 3) of non-commercial R&D for new chemical entities are largely in line with commercial averages. The quantitative data was insufficient to compare attrition rates. The qualitative data identified more reasons why non-commercial R&D costs would be lower than commercial R&D, timelines would be longer, and attrition rates would be equivalent or higher, though the data does not allow for estimating the magnitude of these effects. Conclusions: The quantitative data suggest that costs and timelines per candidate per phase were largely in line with (lower-end estimates of) commercial averages. We were unable to draw conclusions on overall efficiency, however, due to insufficient data on attrition rates. Given that non-commercial R&D is a nascent area of research with limited data available, this study contributes to the literature by generating hypotheses for further testing against a larger sample of quantitative data. It also offers a range of explanatory factors for further exploration regarding how non-commercial and commercial R&D may differ in costs and efficiency.

Design, organisation and impact of treatment optimisation studies in breast, lung and colorectal cancer: The experience of the European Organisation for Research and Treatment of Cancer.

BACKGROUND: Treatment optimisation studies (TOSs) are clinical trials which aim to tackle research questions that are often left unaddressed within the current drug development paradigm due to a lack of financial and regulatory incentives to undertake them. Examples include comparative effectiveness, therapeutic sequencing and dose de-escalation studies. Trials of this nature have historically been primarily carried out by academic institutions and not-for-profit organisations such as the European Organisation for Research and Treatment of Cancer (EORTC). OBJECTIVES: Our objective was to conduct an in-depth analysis of the breast, lung and colorectal cancer TOSs that have been performed by the EORTC in the past four decades. METHODS: We searched the EORTC clinical trials database for relevant studies and subsequently analysed them based on a number of predefined criteria relating to their design, organisation and scientific impact. RESULTS: The 113 EORTC TOSs examined in this analysis were mainly standard-sized, international, multicentre phase III trials using a relatively simple, randomised, open-label design and comparing pharmacological combination regimens against standard-of-care treatments in terms of their potential to improve overall survival of patients with cancer. Although they were typically financially and/or materially supported by the industry, their legal sponsor was nearly always an independent party that did not benefit monetarily from their outcomes. If meaningful findings were obtained, their results, regardless of whether positive or negative, were published in high-impact journals, and the corresponding articles usually received a considerable number of citations. CONCLUSIONS: Our analysis provides an empirical framework for setting up future TOSs based on the EORTC experience in oncology.

Characteristics of HIV/AIDS cases with non-marital or non-commercial heterosexual transmission in Hangzhou / 预防医学

Objective @#To analyze the characteristics of HIV/AIDS cases with non-marital or non-commercial heterosexual transmission in Hangzhou, and the influencing factors for new infection and local infection, so as to provide the evidence for AIDS prevention and control.@*Methods @#From 2017 to 2019, the newly reported HIV/AIDS cases with non-marital or non-commercial heterosexual transmission in Hangzhou were recruited, and their demographic information, previous sexual behaviors and history of HIV testing were collected in the questionnaire survey. The multivariate logistic regression model was used to analyze the influencing factors for new infections and local infections. @*Results @#A total of 522 participants from 668 newly reported HIV/AIDS cases with non-marital or non-commercial heterosexual transmission in Hangzhou during this period were surveyed．Among 522 cases, 263 ( 50.38% ) were aged 40 years or above, 218 ( 41.76% ) were married, 326 ( 62.45% ) had an educational level of junior high school or below, and 340 ( 65.13% ) were not local. Among 504 cases whose infection time could be determined, 72 ( 14.29% ) were newly infected within one year; age of 40 years below ( OR=4.148, 95%CI: 1.956-8.795 ), history of HIV testing ( OR=2.049, 95%CI: 1.163-3.609 ) and history of sexually transmitted diseases ( OR=2.169, 95%CI: 1.076-4.374 ) were risk factors for new infection. Among 454 cases whose infection location could be determined, 267 ( 58.81% ) were infected in Hangzhou; educational level of high school or below ( OR=2.538, 95%CI: 1.252-5.145 ) , Hangzhou residence ( OR=7.835, 95%CI: 4.227-14.353 ), living in Hangzhou for a year or over ( OR=18.960, 95%CI: 8.755-41.060 ) and monthly income of 3 000 yuan or over ( OR=2.630, 95%CI: 1.546-4.474 ) were risk factors for local infection. @*Conclusions @#The HIV/AIDS cases with non-marital or non-commercial heterosexual transmission in Hangzhou are mainly floating population and less educated. The newly infected cases are more likely to be young and middle-aged people and patients with sexually transmitted diseases, the locally infected cases are more likely to be people with permanent residence, less educated and high income.

New insights into the biology, diagnosis and immune response to Dirofilaria repens in the canine host.

Dogs are the primary host for Dirofilaria repens, therefore it is mandatory to accurately diagnose the canine infection and to expand our current knowledge on parasite biology and the immune response of the infected host for a better prevention.Thus, the aim of the present study was to provide new insights from experimental infections of dogs with D. repens, focusing on the evaluation of: 1) the pre-patent period and 2) the antibody response against D. repens somatic antigens and against the Wolbachia endosymbiont. Briefly, on Day 0, twenty purpose-bred Beagle dogs were experimentally infected with 50 infective larvae (L3) of D. repens. Starting from Day 58 until the last day of the study (Day 281), blood samples were collected on a monthly basis for detection of antibodies against D. repens (Dr) and recombinant Wolbachia surface protein (rWSP) by non-commercial IgG-ELISAs. Additional samples were collected on Days 220, 245 and 281 for the detection of microfilariae (mff) using the modified Knott's test and biomolecular analysis, following two PCR protocols: Gioia et al. (2010; protocol A) and Rishniw et al. (2006- protocol B). The results were analysed by univariate statistical analyses using 2 × 2 contingency tables and K Cohen was calculated to assess the agreement among all the diagnostic techniques. Overall, the outcome of the study revealed that out of the 20 dogs experimentally infected with D. repens, 16 (80 %) were microfilaraemic, 17 (85 %) were positive at DNA detection in the blood, 18 (90 %) had D. repens antibodies and 16 (80 %) had Wolbachia antibodies on the last day of the study. The overall k agreement between Knott's and PCR protocol B was 0.442 (P = 0.0001) and increased throughout the study, reaching 0.828 (P = 0.0001) on Day 281. To the authors knowledge, this is only the second study reporting antibody response to D. repens somatic antigen in experimentally infected dogs. ELISA results showed that an antibody response develops before the onset of patency, and steadily increases with time. Results would suggest that the development of an immunological response to infection could lead to application in epidemiological studies, risk assessment and as an aid in the diagnostic approach in dogs, in particular for early infections without mff.

The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic.

INTRODUCTION: Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work. METHOD: A retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications. RESULTS: The search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results. CONCLUSION: The main shortcomings-specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.

[Characteristics of newly reported HIV/AIDS cases with non-marital or non-commercial heterosexual transmission in Guangxi Zhuang Autonomous Region, 2015-2018].

Objective: To understand the characteristics and associated factors of newly reported HIV/AIDS cases with non-marital or non-commercial heterosexual transmission, in Guangxi Zhuang Autonomous Region (Guangxi), 2015-2018. Methods: Information of newly reported HIV/AIDS cases aged ≥18 years in Guangxi between 2015 and 2018 was collected from the National Comprehensive HIV/AIDS Information System. Unconditional logistic regression model was used to access those factors that were associated with HIV infections through non-marital or non-commercial heterosexual contact. Results: Between 2015 and 2018, a total number of 35 497 HIV/AIDS cases, aged ≥18 years were newly reported in Guangxi. Among them, 32 648 (92.0%) were infected heterosexually while 10 500 were infected through non-marital or non-commercial heterosexual behavior. Non-marital or non-commercial heterosexual transmission accounted for 29.6% (10 500/35 497) of the newly reported HIV/AIDS cases, and 32.2% (10 500/32 648) of those with heterosexual transmission. Males counted for 53.5% (5 617/10 500) of non-marital or non-commercial heterosexual transmission and males to females ratio was 1.2∶1 (5 617∶4 883). Those married or had regular sexual partners counted for 55.9% (5 873/10 500). Commercial heterosexual transmission appeared the main mode of HIV transmission for males (64.4%,16 516/25 633) while main mode for females was non-marital or non-commercial heterosexual transmission and counted for 49.5% (4 883/9 864). Results from the multivariate logistic regression analysis showed that adjusted OR of female HIV/AIDS infected HIV via non-marital or non-commercial heterosexual transmission, was 3.98 times (95%CI: 3.78-4.20) hight than that of males. Among the group aged<50 years and the aged 50-59 years, the adjusted ORs were 1.35 times (95%CI: 1.27-1.44) and 1.13 times (95%CI: 1.05-1.21) hight than that of aged ≥60 years. Those who were single/divorced/widowed, the adjusted OR was 1.53 times (95%CI: 1.45-1.61) hight than that of those married/regular partners. Those with junior high school education, high school education and above the adjusted ORs were 1.22 times (95%CI: 1.16-1.29) and 1.18 times (95%CI: 1.10-1.27), compared to those only with education levels of primary school or below. Conclusions: The number of HIV/AIDS cases via non-marital or non-commercial heterosexual transmission accounted for nearly 30.0% of all the routes of HIV transmission in Guangxi, 2015-2018. Female, aged<60 years old, single/divorced/widowed and having had junior and above high school education etc., appeared as risk factors on non-marital or non-commercial heterosexual transmission, among newly reported HIV/AIDS in Guangxi.

New insights into the biology, diagnosis and immune response to Dirofilaria repens in the canine host.

Dogs are the primary host for Dirofilaria repens, therefore it is mandatory to accurately diagnose the canine infection and to expand our current knowledge on parasite biology and the immune response of the infected host for a better prevention.Thus, the aim of the present study was to provide new insights from experimental infections of dogs with D. repens, focusing on the evaluation of: 1) the pre-patent period and 2) the antibody response against D. repens somatic antigens and against the Wolbachia endosymbiont. Briefly, on Day 0, twenty purpose-bred Beagle dogs were experimentally infected with 50 infective larvae (L3) of D. repens. Starting from Day 58 until the last day of the study (Day 281), blood samples were collected on a monthly basis for detection of antibodies against D. repens (Dr) and recombinant Wolbachia surface protein (rWSP) by non-commercial IgG-ELISAs. Additional samples were collected on Days 220, 245 and 281 for the detection of microfilariae (mff) using the modified Knott's test and biomolecular analysis, following two PCR protocols: Gioia et al. (2010; protocol A) and Rishniw et al. (2006- protocol B). The results were analysed by univariate statistical analyses using 2×2 contingency tables and K Cohen was calculated to assess the agreement among all the diagnostic techniques. Overall, the outcome of the study revealed that out of the 20 dogs experimentally infected with D. repens, 16 (80 %) were microfilaraemic, 17 (85 %) were positive at DNA detection in the blood, 18 (90 %) had D. repens antibodies and 16 (80 %) had Wolbachia antibodies on the last day of the study. The overall k agreement between Knott's and PCR protocol B was 0.442 (P=0.0001) and increased throughout the study, reaching 0.828 (P=0.0001) on Day 281. To the authors knowledge, this is only the second study reporting antibody response to D. repens somatic antigen in experimentally infected dogs. ELISA results showed that an antibody response develops before the onset of patency, and steadily increases with time. Results would suggest that the development of an immunological response to infection could lead to application in epidemiological studies, risk assessment and as an aid in the diagnostic approach in dogs, in particular for early infections without mff.

Non-commercial phenotypic assays for the detection of Mycobacterium tuberculosis drug resistance: a systematic review.

Several rapid non-commercial culture-based methods and assays for drug susceptibility testing (DST) of Mycobacterium tuberculosis have emerged over the last decades. The aim of the current review was to summarise evidence on the performance of microscopic observation of drug susceptibility (MODS), thin-layer agar (TLA) and colorimetric redox-indicator (CRI) assays for detection of resistance to first- and second-line anti-tuberculosis (TB) drugs. Forty-three publications satisfying selection criteria were selected for data extraction. MODS and CRI assays demonstrated pooled sensitivity and specificity of > 93% for the detection of resistance to rifampicin and isoniazid and confirmed their utility for an accurate detection of multidrug-resistant TB (MDR-TB) in various settings. Sensitivity and specificity values for indirect DST for ethambutol (EMB) using CRI assays were 94.0% and 82.0%, respectively, suggesting that CRIs could be used to rule out resistance to EMB. Performance for other drugs varied more substantially across the reports. There was no sufficient evidence on the performance of the TLA assay for making any conclusion on its utility for DST. Our data suggests that non-commercial assays could be used for a rapid and accurate DST in settings where the use of commercial World Health Organization-endorsed assays could be limited due to a variety of reasons including limited resources, laboratory facilities or trained personnel. While inexpensive and easy-to-perform MODS and TLA assays can be used in low-income settings, using CRI assays for determination of minimal inhibitory concentrations may be implemented in middle- and high-income countries with high MDR-TB burden to guide clinical management of TB patients.

Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency.

BACKGROUND: Investigator-led multicentre randomised trials are essential to generate evidence on the optimal use of medical interventions. These non-commercial trials are often hampered by underfunding, which may lead to difficulties in gathering a team with the necessary expertise, a delayed trial start, slow recruitment and even early trial discontinuation. As a new public funder of pragmatic clinical trials, the KCE Trials programme was committed to correctly pay all trial activities in order to assure timely delivery of high-quality trial results. As no appropriate trial budget tool was readily publicly available that took into account the costs for the sponsor as well as the costs for participating sites, we developed a tool to make the budgeting of a clinical trial efficient, transparent and fair across applicants. METHODS: All trial-related activities of the sponsor and sites were categorised, and cost drivers were identified. All elements were included in a spreadsheet tool allowing the sponsor team to calculate in detail the various activities of a clinical trial and to appreciate the budget impact of specific cost drivers, e.g. a delay in recruitment. Hourly fees by role were adapted from published data. Fixed amounts per activity were developed when appropriate. RESULTS: This publicly available tool has already been used for 17 trials funded since the start of the KCE Trials programme in 2016, and it continues to be used and improved. This budget tool is used together with additional risk-reducing measures such as a multistep selection process with advance payments, a recruitment feasibility check by sponsor and funder, a close monitoring of study progress and a milestone-based payment schedule with the last payment made when the manuscript is submitted. CONCLUSIONS: The budget tool helps the KCE Trials programme to answer relevant research questions in a timely way, within budget and with high quality, a necessary condition to achieve impact of this programme for patients, clinical practice and healthcare payers.

[What Is Involved in the Training Program for a Japanese Academic Detailer?]

'Academic Detailing' is an approach to providing doctors with information about medicines based on the latest non-commercial evidence-based data for proper prescription. Overseas, pharmacists have been active as academic detailers. Academic Detailing in Japan, as a new approach to disseminating comparative drug information based on basic pharmaceutical sciences and clinical evidence, will influence clinical decision making by doctors, and contribute to better patient-centered medical care. Pharmacists have been participating in ensuring the proper use of drugs by their patients by entering their homes or wards. However, in the future, it is necessary to take steps to improving pharmaceutical decision making by doctors. Therefore, we are considering the following educational points in the Japanese version of training an academic detailer. "A: We shall compare medicines based on basic pharmaceutical sciences and the latest non-commercial evidence-based data. B: We shall understand the point of using medicines based on the patient's condition. C: We shall choose cost-effective drugs from the viewpoint of pharmacoeconomics. And D: We shall acquire communication skills for effective academic detailing." In the future, this first class of Academic Detailers who facilitate academic detailing in the health care field will be pioneers. They will also participate in research to track and quantify the effects of academic detailing.

Non-commercial trials on medicines submitted to the Ethics Committee of the University Hospital of Bologna (Italy) along 8 years of activity: time to update rules and recommendations.

PURPOSE: In Italy, the non-commercial trials on medicines are regulated by the Ministry Decree 17 December, 2004. Its intent is of encouraging the independent research for the improvement of clinical practice. We aimed to analyze the main features of the proposals of non-commercial clinical trials on medicines submitted to the Independent Ethics Committee (IEC) of the University Hospital of Bologna in the period 2010-2017. METHODS: Data were extracted from IEC registry and were organized with an ad hoc database. The relationships between the variables were examined using contingency tables. When appropriate, we applied the chi-square statistical test for the comparison of the categorical variables. RESULTS: Over the 8-year period, the IEC evaluated 2931 studies, of which 1156 (39.4%) related to clinical trials on medicines; 245 (21.2%) out of the latter were non-commercial ones. A percentage of 49.8 of the trials were of phase II; 137 trials (55.9%) were promoted by hospitals, medical schools or institutes for research, hospitalization and health care. Non-profit organizations and scientific societies were promoters of 88 trials (35.9%). Most phase I and phase II trials received additional support from pharmaceutical companies. CONCLUSIONS: Our results show a not negligible industrial influence on non-commercial trials through additional support, mostly to those of phase II. An update of the present legislation on this matter is desirable, adopting clearer rules on the relations sponsor-industry.

Factors associated with condom use with non-commercial partners among sexually-active transgender women in Cambodia: findings from a national survey using respondent-driven sampling.

BACKGROUND: Globally, the prevalence of HIV among transgender women is much higher than that of the general adult population. This can be explained by the persistently low rate of consistent condom use among this population. This study was therefore conducted to explore factors associated with consistent condom use among sexually-active transgender women in Cambodia, specifically with their non-commercial partners. METHODS: Data used for this study were collected as part of the National Integrated Biological and Behavioral Survey 2016. Participants were recruited from the capital city of Phnom Penh and 12 other provinces with high burden of HIV using the Respondent-Driven Sampling (RDS) method. Face-to-face interviews were conducted using a structured questionnaire. Weighted multivariate logistic regression analysis was conducted to explore independent factors associated with consistent condom use. RESULTS: This study included 1202 transgender women who reported having anal sex with at least one male partner not in exchange for money or gifts in the past three months. The mean age of the participants was 26.0 (SD = 7.0) years. Of the total, 41.5% reported always using condoms with male non-commercial partners in the past three months. After adjustment, the likelihood of consistent condom use was significantly higher among participants who resided in an urban community (AOR = 1.7, 95% CI = 1.1-2.6), had attained at least 10 years of formal education (AOR = 1.8, 95% CI = 1.2-2.7), perceived that they were likely or very likely to be HIV infected (AOR = 2.9, 95% CI = 2.0-4.1), reported drinking alcohol two to three times per week (AOR = 3.1, 95% CI = 1.1-8.3), reported using amphetamine-type stimulants (AOR = 1.9, 95% = 1.1-3.8) or other drugs (AOR = 7.6, 95% CI = 1.5-39.5), and reported inconsistent condom use with male commercial partners in the past three months (AOR = 4.3, 95% CI = 1.8-10.4) compared to that of their respective reference group. CONCLUSIONS: This study confirms the low rates of condom use, particularly in non-commercial relationship, among transgender women in Cambodia. To address these concerns, efforts towards education about effects of multiple, concurrent relationships, and inconsistent condom use should be reinforced among transgender women.

Age-Related Trends in the Diet of An Infant's Cohort in the Northeast of Italy from Six to Twelve Months of Age.

Complementary feeding is recognized as an important predictor of health later in life and is likely to affect the development of food preferences. This paper describes age-related trends in terms of energy, nutrients intake and dietary habits of an Italian infant sub cohort (n = 152), enrolled in Trieste. Infant dietary data, collected using a food diary at 6, 9 and 12 months of age, were used to estimate energy and nutrients intake using the Italian food composition database. Age-related trends were calculated using Page's trend test. An increasing age-trend was observed in the percentages of contribution of macronutrients to total energy intake, with the exception of total lipids, which instead decreased over time. Most of the infants shared a low varied diet especially with regards to protein intake sources, represented mainly by dairy and meat products rather than pulses and fish. This could also account for the low intake of essential fatty acids (ω3) that play an important role in infant neurodevelopment. Moreover, non-commercial baby foods contributed more in terms of quantity, energy and macronutrients intake, compared with commercial products. Healthy eating habits should be encouraged during the first year of life, promoting a varied and well balanced diet at family level.

Access and benefit sharing--The perspective of basic research.

BACKGROUND: With the adoption of the Convention on Biological Diversity (CBD) the 196 member countries have agreed that organisms and their derivatives are the property of the country of their origin (CBD Art.3, Art 15). While the spirit of the CBD is generally acknowledged, the ownership causes considerable problems, last not least for research which by the CBD is considered as "use of genetic (=biological) resources" (GR). Such resources include all kinds of material which might contain functional genetic units while the derivatives consist of other materials of biological origin. HYPOTHESIS: Recently, many member countries claim the right of disposal also for digital sequence information about their GR. The Nagoya Protocol (NP) to the CBD regulates access to GR in exchange for sharing benefits arising from their use. Although the main focus of the NP is on "Research and Development" for commercial purposes, many of the issues and regulations apply also to basic, non-profit oriented biodiversity research. RESULTS: According to the NP (Art. 8a), simplified access to GR shall be granted by the provider countries for non-commercial biodiversity research, and a simple research permit may thus be sufficient for research projects not requiring transfer of GR. Nevertheless, there is not yet consensus about the interpretation of the terms "simplified measures" and "basic, academic, non-profit research". Thus negotiations about access to GR for basic research are still an ad-hoc issue at the discretion of a country's relevant authority, termed "Focal Point". Because basic research is mostly financed by public money, compliance of the researcher with the international regulations is of public interest, and in the EU, additional regulations shall make this sure on the part of the researcher by an obligatory declaration of "due diligence". CONCLUSION: Apart from all legal uncertainties on both sides the provider country and the researcher, respect of legal commitments and mutual trust are indispensable for overcoming ABS-difficulties in basic research.

[Characteristics of newly reported HIV/AIDS cases with non-marital but non-commercial heterosexual transmission in Hangzhou, 2015-2017].

Objective: To describe the characteristics of newly reported HIV/AIDS cases via non-marital or non-commercial heterosexual transmission and to find out the relative factors in Hangzhou, from 2015 to 2017. Methods: Data were collected through the national HIV/AIDS comprehensive control and prevention data system. Study subjects would include those reported HIV/AIDS cases who were residents of Hangzhou and were infected via non-marital heterosexual transmission, between January 1, 2015 and December 31, 2017. Demographic characteristics and behavioral information were collected. χ(2) test was used to compare different characteristics of the non-married heterosexual transmission subjects. Logistic regression was used to assess factors that associated with non-marital but non-commercial HIV heterosexual transmission with SPSS. 20 software used to analyze statistically. Results: Non-marital HIV heterosexual transmission accounted for 38.03% (1 393/3 663) of the total new reported HIV/AIDS cases in 2015-2017. Out of the 1 393 HIV/AIDS cases, those infected through non-marital but non-commercial heterosexual transmission accounted for 50.83% (708/1 393), and those through non-martial commercial transmission was accounted for 49.17% (685/1 393). Male to female ratio was 3.51 ∶ 1 (1 084/309). Male HIV cases reported that their major way of infection was via non-marital commercial transmission (670/1 084, 61.81%), while female patients reported the way was via non-marital non-commercial (294/309, 95.1%). Results from multivariate logistic analysis showed that the related risk factors and ORs for non-marital but non-commercial transmission appeared as: female (aOR=48.25, 95%CI: 26.94- 88.44),<30 year olds (aOR=2.43, 95%CI: 1.31-4.51), 30-39 year olds (aOR=1.92, 95%CI: 1.11- 3.33), 40-49 year olds (aOR=1.80, 95%CI: 1.08-3.00), married or unmarried (vs. divorced or widowed, aOR=1.57, 95%CI: 1.10-2.24; aOR=1.78, 95%CI: 1.15-2.78), high school and above of education level (vs. primary school and under of education level, aOR=1.82, 95%CI: 1.18-2.80), administrative officers or employee (vs. farmers, aOR=2.03, 95%CI: 1.04-1.91). Number of non- marital partners less than 5 (vs. number of non-marital partners more than 5, aOR=10.65, 95%CI: 6.41-17.42). Conclusions: HIV/AIDS cases with non-marital heterosexual transmission accounted for considerable proportion regarding the HIV transmission in Hangzhou from 2015 to 2017. Differences were found in the following factors as non-marital and non-commercial heterosexual transmission with diverse gender, age, marital status, educational level and occupation among of the HIV/AIDS patients.