Serum Metabolomics Reveals Underlying Mechanisms of Cholesterol‐Lowering Effects of Oat Consumption: A Randomized Controlled Trial in a Mildly Hypercholesterolemic Population

2021 ◽  
pp. 2001059
Author(s):  
Dengfeng Xu ◽  
Shaokang Wang ◽  
Meiyuan Feng ◽  
Varsha Shete ◽  
Yifang Chu ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cholesterol Lowering ◽  
Randomized Controlled ◽  
Underlying Mechanisms ◽  
Serum Metabolomics

scholarly journals Mitochondrial Reprogramming—What Is the Benefit of Hypothermic Oxygenated Perfusion in Liver Transplantation?

2021 ◽  
Vol 2 (2) ◽  
pp. 149-161
Author(s):  
Rebecca Panconesi ◽  
Mauricio Flores Carvalho ◽  
Matteo Mueller ◽  
Philipp Dutkowski ◽  
Paolo Muiesan ◽  
...  
Keyword(s):  
Liver Transplantation ◽  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Cohort Studies ◽  
Controlled Trial ◽  
Machine Perfusion ◽  
Randomized Controlled ◽  
Hypothermic Perfusion ◽  
Underlying Mechanisms ◽  
Circulatory Death

Although machine perfusion is a hot topic today, we are just at the beginning of understanding the underlying mechanisms of protection. Recently, the first randomized controlled trial reported a significant reduction of ischemic cholangiopathies after transplantation of livers donated after circulatory death, provided the grafts were treated with an endischemic hypothermic oxygenated perfusion (HOPE). This approach has been known for more than fifty years, and was initially mainly used to preserve kidneys before implantation. Today there is an increasing interest in this and other dynamic preservation technologies and various centers have tested different approaches in clinical trials and cohort studies. Based on this, there is a need for uniform perfusion settings (perfusion route and duration), and the development of general guidelines regarding the duration of cold storage in context of the overall donor risk is also required to better compare various trial results. This article will highlight how cold perfusion protects organs mechanistically, and target such technical challenges with the perfusion setting. Finally, the options for viability testing during hypothermic perfusion will be discussed.

scholarly journals Effects of a Novel, Transdiagnostic, Hybrid Ecological Momentary Intervention for Improving Resilience in Youth (EMIcompass): Protocol for an Exploratory Randomized Controlled Trial

10.2196/27462 ◽  
2021 ◽  
Vol 10 (12) ◽  
pp. e27462
Author(s):  
Anita Schick ◽  
Isabell Paetzold ◽  
Christian Rauschenberg ◽  
Dusan Hirjak ◽  
Tobias Banaschewski ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Stress Reactivity ◽  
Controlled Trial ◽  
Youth Mental Health ◽  
Preventive Strategy ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Underlying Mechanisms ◽  
Ecological Momentary

Background Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype of psychosis, mania, depression, and anxiety. Elevated stress reactivity is one of the most widely studied mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes that could develop later in life and for improving resilience. Compassion-focused interventions offer a wide range of innovative therapeutic techniques that are particularly amenable to being implemented as ecological momentary interventions (EMIs), a specific type of mobile health intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge the current gap in youth mental health care. Objective This study aims to investigate the clinical feasibility, candidate underlying mechanisms, and initial signals of the efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth—EMIcompass. Methods In an exploratory randomized controlled trial, youth aged between 14 and 25 years with current distress, a broad Clinical High At-Risk Mental State, or the first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (ie, EMI plus face-to-face training sessions) in addition to treatment as usual or a control condition of treatment as usual only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, and momentary physiological markers of stress reactivity), as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms and general psychopathology), will be assessed at baseline, postintervention, and at the 4-week follow-up. Results The first enrollment was in August 2019, and as of May 2021, enrollment and randomization was completed (N=92). We expect data collection to be completed by August 2021. Conclusions This study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of the efficacy of a compassion-focused EMI in youth. If successful, a confirmatory randomized controlled trial will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision. Trial Registration German Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265 International Registered Report Identifier (IRRID) DERR1-10.2196/27462

scholarly journals The effects of a novel, accessible, transdiagnostic ecological momentary intervention for improving resilience in youth (EMIcompass): study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Anita Schick ◽  
Isabell Pätzold ◽  
Christian Rauschenberg ◽  
Dusan Hirjak ◽  
Tobias Banaschewski ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Stress Reactivity ◽  
Controlled Trial ◽  
Youth Mental Health ◽  
Preventive Strategy ◽  
Ecological Momentary Intervention ◽  
Randomized Controlled ◽  
Underlying Mechanisms ◽  
Ecological Momentary

Background: Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype. Elevated stress reactivity is one of the most widely studied psychological mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes later in life and for improving resilience. Compassion-focused interventions (CFIs) offer a wide range of innovative therapeutic techniques particularly amenable to being implemented as an Ecological Momentary Intervention (EMI) to enable youth to access interventions in a given moment and context in daily life. This approach may bridge a gap in current youth mental health care. The aim of this study will be to investigate the clinical feasibility, candidate underlying mechanisms and initial signals of efficacy of a novel, accessible, transdiagnostic EMI for improving resilience to stress in youth (EMIcompass).Methods/Design: In an exploratory randomized controlled trial (RCT), youth aged 14-25 with current distress, a broad Clinical High At-Risk Mental State (CHARMS) or a first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention in addition to treatment as usual (TAU) or a control condition of TAU only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals) as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms, general psychopathology) will be assessed at baseline, post-intervention and 4-week follow-up. Discussion: The current study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of efficacy of a compassion-focused EMI in youth. If successful, a confirmatory RCT will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision. Trial registration number: German Trial Registry (DRKS), DRKS00017265; Date of registration: 31.07.2019.

scholarly journals Printed educational materials directed at Ontario family physicians do not improve adherence to guideline recommendations for diabetes management: a pragmatic, factorial, cluster randomized controlled trial [ISRCTN72772651]

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alison H. Howie ◽  
Neil Klar ◽  
Danielle M. Nash ◽  
Jennifer N. Reid ◽  
Merrick Zwarenstein
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Family Physicians ◽  
Educational Materials ◽  
Cholesterol Lowering ◽  
Randomized Controlled ◽  
Patients With Diabetes ◽  
Cluster Randomized ◽  
Printed Educational Materials ◽  
To Receive

Abstract Background Printed educational materials (PEMs) have long been used to inform clinicians on evidence-based practices. However, the evidence for their effects on patient care and outcomes is unclear. In Ontario, despite widely available clinical practice guidelines recommending antihypertensives and cholesterol-lowering agents for patients with diabetes, prescriptions remain low. We aimed to determine whether PEMs can influence physicians to intensify prescribing of these medications. Methods A pragmatic, 2 × 2 factorial, cluster randomized controlled trial was designed to ascertain the effect of two PEM formats on physician prescribing: a postcard-sized message (“outsert”) or a longer narrative article (“insert”). Ontario family physician practices (clusters) were randomly allocated to receive the insert, outsert, both or neither. Physicians were eligible if they were in active practice and their patients were included if they were over 65 years with a diabetes diagnosis; both were unaware of the trial. Administrative databases at ICES (formerly the Institute for Clinical Evaluative Sciences) were used to link patients to their physician and to analyse prescribing patterns at baseline and 1 year following PEM mailout. The primary outcome was intensification defined as the addition of a new antihypertensive or cholesterol-lowering agent, or dose increase of a current drug, measured at the patient level. Analyses were by intention-to-treat and accounted for the clustering of patients to physicians. Results We randomly assigned 4231 practices (39% of Ontario family physicians) with a total population of 185,526 patients (20% of patients with diabetes in Ontario primary care) to receive the insert, outsert, both, and neither; among these, 4118 practices were analysed (n = 1025, n = 1037, n = 1031, n = 1025, respectively). No significant treatment effect was found for the outsert (odds ratio (OR) 1.01, 95% confidence interval (CI) 0.98 to 1.04) or the insert (OR 0.99, 95% CI 0.96 to 1.02). Percent of intensification in the four arms was similar (approximately 46%). Adjustment for physician characteristics (e.g., age, sex, practice location) had no impact on these findings. Conclusions PEMs have no effect on physician’s adherence to recommendations for the management of diabetes-related complications in Ontario. Further research should investigate the effect of other strategies to narrow this evidence-to-practice gap. Trial registration ISRCTN72772651. Retrospectively registered 21 July 2005.

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