Organic Food and Health: A new project to study the effects of plant cultivation methods (organic and conventional) on nutritional value, health and reproduction in an animal experiment

Many consumers believe that food from plants grown under certain conditions, such as organic agriculture, will benefit health more than conventional food. This cannot be determined simply by analysing the material, since our understanding of the connections between food components and health is still to imprecise for such a purpose. Rather than waiting until basic research provides the knowledge needed for this approach, in the spring of 2001 we have initiated a project to study physiological effects of plant quality directly, in an animal experiment. The following cultivation treatments are used to grow plants that are typical ingredients for a human diet (potato, mature peas, kale, spring wheat, oilseed rape, carrots and apples): 1. A model of a distinct conventional cultivation system, with high input of mineral nutrients and use of as much pesticides as is allowed. 2. A model of a distinct organic cultivation system, with low input of organic plant nutrients and no use of pesticides. 3. A combination of model 1 and 2, with low input of nutrients and use of pesticides. The materials from each cultivation treatment will be thoroughly characterised, by measuring contents of nutrients (protein, minerals, energy content, vitamins), the biological value of major protein sources of feed plants will be assessed, selected secondary metabolites including known anti-nutrients will be measured and other quality indicators will be assessed including biocrystallization. Based on these results, 3 feed mixtures will be prepared, either based on defined weight percentages of each material from each treatment, or, if large variation in biological value is found, one or two feed mixtures can be adjusted to provide the same availability of protein and energy as the reference treatment (model 1). Potato, mature peas and kale will be cooked and freeze-dried, wheat is ground and baked to biscuits, oil is produced from the rapeseed, and raw carrots and apples are shredded and freeze dried, before feed pellets with the desired composition are prepared from the material. Three groups of rats are each provided one of the dietary treatments during 2.5 generation, and reproductive characteristics and performance are recorded. Subgroups of the last generation are selected for an intensive study in which uptake and excretion of energy and protein and selected micronutrients are determined. Respiration trials are performed to assess the energy metabolism, and simultaneous measurements of the activity levels of the rats are performed. In addition, blood and tissue samples of the rats will be obtained to study the effect of the dietary treatments on the immunological and antioxidant status of the rats. Data from the experiments are assembled and analysed using relevant statistical models, and the relationship to the nutritional characteristics of the plant material is described. Funding for the core project for a 4-year period is secured from the Danish Research Centre for Organic Farming (DARCOF). However, the intention is to provide a platform for international collaboration, since the well-documented material of plants and animals can provide multiple opportunities for associated projects. To investigate other aspects of plant composition or health than what is foreseen in the present project, or to follow up on it with additional experiments

Exercise-Based Real-time Telerehabilitation for Older Adult Patients Recently Discharged After Transcatheter Aortic Valve Implantation:Mixed Methods Feasibility Study

BACKGROUND: The use of telehealth technology to improve functional recovery following transcatheter aortic valve implantation (TAVI) has not been investigated. OBJECTIVE: In this study, we aimed to examine the feasibility of exercise-based cardiac telerehabilitation after TAVI. METHODS: This was a single-center, prospective, nonrandomized study using a mixed methods approach. Data collection included testing, researchers’ observations, logbooks, and individual patient interviews, which were analyzed using a content analysis approach. The intervention lasted 3 weeks and consisted of home-based web-based exercise training, an activity tracker, a TAVI information website, and 1 web-based session with a nurse. RESULTS: Of the initially included 13 patients, 5 (40%) completed the study and were interviewed; the median age was 82 (range 74-84) years, and the sample comprised 3 men and 2 women. Easy access to supervised exercise training at home with real-time feedback and use of the activity tracker to count daily steps were emphasized by the patients who completed the intervention. Reasons for patients not completing the program included poor data coverage, participants’ limited information technology skills, and a lack of functionality in the systems used. No adverse events were reported. CONCLUSIONS: Exercise-based telerehabilitation for older people after TAVI, in the population as included in this study, and delivered as a web-based intervention, does not seem feasible, as 60% (8/13) of patients did not complete the study. Those completing the intervention highly appreciated the real-time feedback during the web-based training sessions. Future studies should address aspects that support retention rates and enhance patients’ information technology skills

Perspectives on Participation in a Feasibility Study on Exercise-Based Cardiac Telerehabilitation After Transcatheter Aortic Valve Implantation:Qualitative Interview Study Among Patients and Health Professionals

BACKGROUND: Aortic valve stenosis affects approximately half of people aged ≥85 years, and the recommended surgical treatment for older patients is transcatheter aortic valve implantation (TAVI). Despite strong evidence for its advantages, low attendance rate in cardiac rehabilitation is observed among patients after TAVI. Cardiac telerehabilitation (CTR) has proven comparable with center-based rehabilitation; however, no study has investigated CTR targeting patients after TAVI. On the basis of participatory design, an exercise-based CTR program (TeleTAVI) was developed, which included a web-based session with a cardiac nurse, a tablet containing an informative website, an activity tracker, and supervised home-based exercise sessions that follow the national recommendations for cardiac rehabilitation. OBJECTIVE: This study aims to explore patients’ and health professionals’ experiences with using health technologies and participating in the exercise-based CTR program, TeleTAVI. METHODS: This study is a part of a feasibility study and will only report patients’ and health professionals’ experiences of being a part of TeleTAVI. A total of 11 qualitative interviews were conducted using a semistructured interview guide (n=7, 64% patients and n=4, 36% health professionals). Patient interviews were conducted after 8 weeks of participation in TeleTAVI, and interviews with health professionals were conducted after the end of the program. The analysis was conducted as inductive content analysis to create a condensed meaning presented as themes. RESULTS: Reticence toward using the website was evident with reduced curiosity to explore it, and reduced benefit from using the activity tracker was observed, as the patients’ technical competencies were challenged. This was also found when using the tablet for web-based training sessions, leading to patients feeling worried before the training, as they anticipated technical problems. Disadvantages of the TeleTAVI program were technical problems and inability to use hands-on guidance with the patients. However, both physiotherapists and patients reported a feeling of improvement in patients’ physical fitness. The home training created a feeling of safety, supported adherence, and made individualization possible, which the patients valued. A good relationship and continuity in the contact with health professionals seemed very important for the patients and affected their positive attitude toward the program. CONCLUSIONS: The home-based nature of the TeleTAVI program seems to provide the opportunity to support individualization, autonomy, independence, and adherence to physical training in addition to improvement in physical capability in older patients. Despite technological challenges, basing the relationship between the health professionals and patients on continuity may be beneficial for patients. Prehabilitation may also be considered, as it may create familiarity toward technology and adherence to the training

RootPainter: Deep Learning Segmentation of Biological Images with Corrective Annotation

We present RootPainter, a GUI-based software tool for the rapid training of deep neural networks for use in biological image analysis. RootPainter facilitates both fully-automatic and semiautomatic image segmentation. We investigate the effectiveness of RootPainter using three plant image datasets, evaluating its potential for root length extraction from chicory roots in soil, biopore counting and root nodule counting from scanned roots. We also use RootPainter to compare dense annotations to corrective ones which are added during the training based on the weaknesses of the current model

Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial

BACKGROUND: Passive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited. METHODS: In this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581. FINDINGS: From Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77–1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66–1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14–4·29); for patients who were antibody negative, the OR was 0·51 (0·29–0·90; pinteraction=0·001). INTERPRETATION: When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry. FUNDING: US National Institutes of Health

The cross-sectional GRAS sample: A comprehensive phenotypical data collection of schizophrenic patients

<p>Abstract</p> <p>Background</p> <p>Schizophrenia is the collective term for an exclusively clinically diagnosed, heterogeneous group of mental disorders with still obscure biological roots. Based on the assumption that valuable information about relevant genetic and environmental disease mechanisms can be obtained by association studies on patient cohorts of ≥ 1000 patients, if performed on detailed clinical datasets and quantifiable biological readouts, we generated a new schizophrenia data base, the GRAS (Göttingen Research Association for Schizophrenia) data collection. GRAS is the necessary ground to study genetic causes of the schizophrenic phenotype in a 'phenotype-based genetic association study' (PGAS). This approach is different from and complementary to the genome-wide association studies (GWAS) on schizophrenia.</p> <p>Methods</p> <p>For this purpose, 1085 patients were recruited between 2005 and 2010 by an invariable team of traveling investigators in a cross-sectional field study that comprised 23 German psychiatric hospitals. Additionally, chart records and discharge letters of all patients were collected.</p> <p>Results</p> <p>The corresponding dataset extracted and presented in form of an overview here, comprises biographic information, disease history, medication including side effects, and results of comprehensive cross-sectional psychopathological, neuropsychological, and neurological examinations. With >3000 data points per schizophrenic subject, this data base of living patients, who are also accessible for follow-up studies, provides a wide-ranging and standardized phenotype characterization of as yet unprecedented detail.</p> <p>Conclusions</p> <p>The GRAS data base will serve as prerequisite for PGAS, a novel approach to better understanding 'the schizophrenias' through exploring the contribution of genetic variation to the schizophrenic phenotypes.</p

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049