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JOURNAL ARTICLE
Erlend Sunde, Anette Harris, Olav Kjellevold Olsen, Ståle Pallesen
BACKGROUND: Cognitive function, including moral decision-making abilities, can be impaired by sleep loss. Blue-enriched light interventions have been shown to ameliorate cognitive impairment during night work. This study investigated whether the quality of moral decision-making during simulated night work differed for night work in blue-enriched white light, compared to warm white light. METHODS: Using a counterbalanced crossover design, three consecutive night shifts were performed in blue-enriched white light (7000 K) and warm white light (2500 K) provided by ceiling-mounted LED luminaires (photopic illuminance: ∼200 lx)...
December 2024: Annals of Medicine
#2
JOURNAL ARTICLE
Kübra Gülirmak Güler, Serap Güleç Keski N, Eda Albayrak
AIM: This research aimed to assess the impact of the online "Positive Psychotherapy- Based Key Model of Courtesy and Integrity" (KMCI)" program on the effective communication skills of nursing students. BACKGROUND: With the growing integration of virtual platforms in psychotherapy education, there is a burgeoning interest in understanding their influence on nursing student's communication abilities. Recognizing how online positive psychotherapy education shapes these skills is pivotal for enriching nursing education and practice...
April 11, 2024: Nurse Education in Practice
#3
JOURNAL ARTICLE
Lukas Niekrenz, Cord Spreckelsen
BACKGROUND: eLearning can be an effective tool to achieve learning objectives. It facilitates asynchronous distance learning, increasing flexibility for learners and instructors. In this context, the high educational value of videos provides an invaluable primary component for longitudinal digital curricula, especially for maintaining knowledge on otherwise rarely taught subjects. Although literature concerning eLearning evaluation exists, research comprehensively describing how to design effective educational videos is lacking...
December 31, 2024: Medical Education Online
#4
JOURNAL ARTICLE
Eugénie Vaillant-Coindard, Gaëtan Briet, Florence Lespiau, Béatrice Gisclard, Elodie Charbonnier
Adolescence is a strategic developmental stage in terms of preventing later difficulties and ensuring good mental health. Prophylactic interventions, which are conducted before the onset, prolongation, or worsening of difficulties, and aim to prevent or reduce symptoms or to promote wellbeing, therefore appear particularly appropriate for adolescents. However, existing prophylactic interventions conducted with adolescents have several weaknesses, including sparse theoretical frameworks, ambivalent evidence of their efficacy, and implementation and dissemination difficulties...
April 13, 2024: BMC Psychology
#5
JOURNAL ARTICLE
Isabella C Glitza, Yongwoo David Seo, Christine N Spencer, Jennifer R Wortman, Elizabeth M Burton, Farah A Alayli, Christopher P Loo, Shikha Gautam, Ashish Damania, Julie Densmore, Justin Fairchild, Christopher R Cabanski, Matthew C Wong, Christine B Peterson, Brian Weiner, Nathan Hicks, John G Auniņš, Christopher McChalicher, Emily Walsh, Michael T Tetzlaff, Omid Hamid, Patrick A Ott, Genevieve M Boland, Ryan J Sullivan, Kenneth F Grossmann, Nadim J Ajami, Theresa LaVallee, Matthew R Henn, Hussein A Tawbi, Jennifer A Wargo
UNLABELLED: Gut-microbiota modulation shows promise in improving immune-checkpoint blockade (ICB) response; however, precision biomarker-driven, placebo-controlled trials are lacking. We performed a multicenter, randomized placebo-controlled, biomarker-stratified phase I trial in patients with ICB-naïve metastatic melanoma using SER-401, an orally delivered Firmicutes-enriched spore formulation. Fecal microbiota signatures were characterized at baseline; patients were stratified by high versus low Ruminococcaceae abundance prior to randomization to the SER-401 arm (oral vancomycin-preconditioning/SER-401 alone/nivolumab + SER-401), versus the placebo arm [placebo antibiotic/placebo microbiome modulation (PMM)/nivolumab + PMM (NCT03817125)]...
April 4, 2024: Cancer Discovery
#6
JOURNAL ARTICLE
Abigail K Jenkins, Jenna J Bromm, Jordan T Gebhardt, Jason C Woodworth, Robert D Goodband, Mike D Tokach, Joel M DeRouchey
A total of 720 barrows (Line 200 × 400, DNA Genetics) were used in two 42-d nursery trials (initially 6.20 ± 0.12 kg and 5.63 ± 0.16 kg, respectively) to evaluate strategies for allotting pigs to pens in randomized controlled trials. At placement, the population was split into 3 cohorts with similar average weight and standard deviation and randomly assigned to 1 of 3 allotment strategies. Strategy 1 (random) utilized a simple randomization strategy with each pig randomized to pens independent of all other pigs...
April 4, 2024: Journal of Animal Science
#7
REVIEW
Jiayue Xu, Wenkai Wu, Xia Zhang, Yan Ren, Minghong Yao, Mei Liu, Kang Zou, Wen Wang, Xin Sun
There is a growing demand for the use of high-quality real-world evidence (RWE) to support regulatory decision-making worldwide and in China, which highlights the need for conducting literature reviews to evaluate the available data and evidence. This study aims to review the use of RWE in Chinese regulatory decisions and to summarize relevant regulatory and methodological considerations to inform the future use of RWE in China. We identified policy documents, technical guidance documents, and cases on official Chinese government websites and extracted their contents separately...
April 2, 2024: Clinical Pharmacology and Therapeutics
#8
Ester Calvo Fernández, Lorenzo Tomassoni, Xu Zhang, Junqiang Wang, Aleksandar Obradovic, Pasquale Laise, Aaron T Griffin, Lukas Vlahos, Hanna E Minns, Diana V Morales, Christian Simmons, Matthew Gallitto, Hong-Jian Wei, Timothy J Martins, Pamela S Becker, John R Crawford, Theophilos Tzaridis, Robert J Wechsler-Reya, James Garvin, Robyn D Gartrell, Luca Szalontay, Stergios Zacharoulis, Cheng-Chia Wu, Zhiguo Zhang, Andrea Califano, Jovana Pavisic
Diffuse Midline Gliomas (DMGs) are universally fatal, primarily pediatric malignancies affecting the midline structures of the central nervous system. Despite decades of clinical trials, treatment remains limited to palliative radiation therapy. A major challenge is the coexistence of molecularly distinct malignant cell states with potentially orthogonal drug sensitivities. To address this challenge, we leveraged established network-based methodologies to elucidate Master Regulator (MR) proteins representing mechanistic, non-oncogene dependencies of seven coexisting subpopulations identified by single-cell analysis-whose enrichment in essential genes was validated by pooled CRISPR/Cas9 screens...
March 17, 2024: bioRxiv
#9
JOURNAL ARTICLE
Poornima Jayadev Menon, Sara Sambin, Baptiste Criniere-Boizet, Thomas Courtin, Christelle Tesson, Fanny Casse, Melanie Ferrien, Louise-Laure Mariani, Stephanie Carvalho, Francois-Xavier Lejeune, Sana Rebbah, Gaspard Martet, Marion Houot, Aymeric Lanore, Graziella Mangone, Emmanuel Roze, Marie Vidailhet, Jan Aasly, Ziv Gan Or, Eric Yu, Yves Dauvilliers, Alexander Zimprich, Volker Tomantschger, Walter Pirker, Ignacio Álvarez, Pau Pastor, Alessio Di Fonzo, Kailash P Bhatia, Francesca Magrinelli, Henry Houlden, Raquel Real, Andrea Quattrone, Patricia Limousin, Prasad Korlipara, Thomas Foltynie, Donald Grosset, Nigel Williams, Derek Narendra, Hsin-Pin Lin, Carna Jovanovic, Marina Svetel, Timothy Lynch, Amy Gallagher, Wim Vandenberghe, Thomas Gasser, Kathrin Brockmann, Huw R Morris, Max Borsche, Christine Klein, Olga Corti, Alexis Brice, Suzanne Lesage, Jean Christophe Corvol
Bi-allelic pathogenic variants in PRKN are the most common cause of autosomal recessive Parkinson's disease (PD). 647 patients with PRKN-PD were included in this international study. The pathogenic variants present were characterised and investigated for their effect on phenotype. Clinical features and progression of PRKN-PD was also assessed. Among 133 variants in index cases (n = 582), there were 58 (43.6%) structural variants, 34 (25.6%) missense, 20 (15%) frameshift, 10 splice site (7.5%%), 9 (6...
March 29, 2024: NPJ Parkinson's Disease
#10
JOURNAL ARTICLE
Richard Omore, Alex O Awuor, Billy Ogwel, Caleb Okonji, Catherine Sonye, Caren Oreso, Victor Akelo, Manase Amollo, Isaiah Ogudi, Raphael O Anyango, Marjorie Audi, Evans Apondi, Laura Riziki, Lilian Ambila, Nasrin Dilruba, Erick Muok, Stephen Munga, John B Ochieng, Karen L Kotloff
BACKGROUND: Although Shigella is an important cause of diarrhea in Kenyan children, robust research platforms capable of conducting incidence-based Shigella estimates and eventual Shigella- targeted clinical trials are needed to improve Shigella -related outcomes in children. Here, we describe characteristics of a disease surveillance platform whose goal is to support incidence and consequences of Shigella diarrhea as part of multicounty surveillance aimed at preparing sites and assembling expertise for future Shigella vaccine trials...
March 2024: Open Forum Infectious Diseases
#11
COMPARATIVE STUDY
Kenji Harada, Shunsuke Ono
Pharmaceutical companies have adopted biomarker-based enrichment (personalized) strategies to improve research and development productivity. We explored the background in which personalized strategies are adopted and examined whether their adoption is linked to improved efficacy of new drugs approved for non-small cell lung cancer (NSCLC) by US Food and Drug Administration (FDA). We extracted data from the first labels of drugs approved for NSCLC between May 2003 and February 2021, and performed a qualitative comparative analysis and meta-analysis...
March 26, 2024: Scientific Reports
#12
Tao Wen, Xuan Liu, Tao Pang, Mingming Li, Guangyang Jiao, Xiangcheng Fan, Jigui Tang, Ci'an Zhang, Zhipeng Wang, Xiaoqiang Yue, Wansheng Chen, Feng Zhang
PURPOSE: The aim of this study was to verify the effectiveness and explore the mechanism of Chaihu-Guizhi-Ganjiang decoction (CGGD) in the treatment of chronic non-atrophic gastritis (CNAG) with gallbladder heat and spleen cold syndrome (GHSC) by metabolomics based on UHPLC-Q-TOF/MS. PATIENTS AND METHODS: An observational controlled before-after study was conducted to verify the effectiveness of CGGD in the treatment of CNAG with GHSC from January to June 2023, enrolling 27 patients, who took CGGD for 28 days...
2024: Drug Design, Development and Therapy
#13
REVIEW
Kelly H Zou, Chelsea Vigna, Aniketh Talwai, Rahul Jain, Aaron Galaznik, Marc L Berger, Jim Z Li
Conducting clinical trials (CTs) has become increasingly costly and complex in terms of designing and operationalizing. These challenges exist in running CTs on novel therapies, particularly in oncology and rare diseases, where CTs increasingly target narrower patient groups. In this study, we describe external control arms (ECA) and other relevant tools, such as virtualization and decentralized clinical trials (DCTs), and the ability to follow the clinical trial subjects in the real world using tokenization...
March 25, 2024: Therapeutic Innovation & Regulatory Science
#14
REVIEW
Matthieu Legrand, Sean M Bagshaw, Pavan K Bhatraju, Azra Bihorac, Ellen Caniglia, Ashish K Khanna, John A Kellum, Jay Koyner, Michael O Harhay, Fernando G Zampieri, Alexander Zarbock, Kevin Chung, Kathleen Liu, Ravindra Mehta, Peter Pickkers, Abigail Ryan, Juliane Bernholz, Laura Dember, Martin Gallagher, Patrick Rossignol, Marlies Ostermann
Acute kidney injury (AKI) often complicates sepsis and is associated with high morbidity and mortality. In recent years, several important clinical trials have improved our understanding of sepsis-associated AKI (SA-AKI) and impacted clinical care. Advances in sub-phenotyping of sepsis and AKI and clinical trial design offer unprecedented opportunities to fill gaps in knowledge and generate better evidence for improving the outcome of critically ill patients with SA-AKI. In this manuscript, we review the recent literature of clinical trials in sepsis with focus on studies that explore SA-AKI as a primary or secondary outcome...
March 21, 2024: Critical Care: the Official Journal of the Critical Care Forum
#15
JOURNAL ARTICLE
Agnieszka Smrokowska-Reichmann, Edyta Janus, Jeanette Tamplin, Helen Odell-Miller, Karette Stensæth, Jennifer Wenborn, Rønnaug Modell Viken, Thomas Wosch, Anna A Bukowska, Tanara Vieira Sousa, Felicity Anne Baker
The behavioral and psychological symptoms of dementia (BPSD) can be challenging for family caregivers to cope with, leading to distress and fatigue. It is therefore important to offer effective strategies to reduce the impact of BPSD. The HOMESIDE randomized controlled trial (RCT) was testing purposefully developed interventions to improve the quality of life and wellbeing of dyads of people with dementia and family caregivers as a result of reduction of BPSD. HOMESIDE RCT was conducted in Australia, Germany, Norway, Poland and the United Kingdom between 2019 and 2022...
2024: Gerontology & Geriatric Medicine
#16
REVIEW
N Howden, K Branch, P Douglas, M Gray, M Budoff, M Dewey, D E Newby, S J Nicholls, R Blankstein, S Fathieh, S M Grieve, G A Figtree
Atherosclerotic coronary artery disease (CAD) is the causal pathological process driving most major adverse cardiovascular events (MACE) worldwide. The complex development of atherosclerosis manifests as intimal plaque which occurs in the presence or absence of traditional risk factors. There are numerous effective medications for modifying CAD but new pharmacologic therapies require increasingly large and expensive cardiovascular outcome trials to assess their potential impact on MACE and to obtain regulatory approval...
2024: Frontiers in Cardiovascular Medicine
#17
JOURNAL ARTICLE
Qi Zhao, Le Bai, Dongwei Zhu, Tingyuan Li, Jie Xu, Yong Xu, Xianmei Zhou
BACKGROUND: The ginseng polysaccharide injection is a well-known traditional Chinese medicine often employed as a supplementary treatment for cancer. This treatment can not only alleviate the adverse effects caused by tumor radiotherapy and chemotherapy but also enhance the immune system of individuals diagnosed with lung cancer. It is important to acknowledge the efficacy of ginseng polysaccharide injection in the treatment of non-small cell lung cancer (NSCLC). However, these small-sample studies may have certain biases, and the underlying mechanisms of ginseng polysaccharides therapy for NSCLC are still unclear...
March 30, 2024: Heliyon
#18
JOURNAL ARTICLE
Fabienne El-Khoury, Jean-Christophe Mino, Nicolas Deschamps, Chloé Lopez, Gwenn Menvielle, Patricia Dargent-Molina
INTRODUCTION: Breast cancer survivors (BCSs) are often faced with multiple mental and physical sequelae and are at increased risk of emotional distress, degraded health-related quality of life (HRQoL), chronic pain and fatigue.Physical activity is strongly associated with improved HRQoL and survival rates; however, adherence rates to recommendations for a healthy lifestyle are seldom satisfactory among BCSs. Also, few studies have examined the effectiveness of multicomponent and personalised interventions that integrate physical activity and motivational techniques to improve the HRQoL of BCS...
March 14, 2024: BMJ Open
#19
JOURNAL ARTICLE
Michael B Sohn, Bei Gao, Cynthia Kendrick, Anvesha Srivastava, Tamara Isakova, Jennifer J Gassman, Linda F Fried, Myles Wolf, Alfred K Cheung, Kalani L Raphael, Patricia Centron Vinales, John P Middleton, Ana Pabalan, Dominic S Raj
INTRODUCTION: Disruption of gut microbiota underpins some of the metabolic alterations observed in chronic kidney disease (CKD). METHODS: In a nonrandomized, open-label, 3-phase pilot trial, with repeated measures within each phase, we examined the efficacy of oligofructose-enriched inulin (p-inulin) in changing the gut microbiome and their metabolic products in 15 patients with CKD. The stability of microbiome and metabolome was studied during the pretreatment phase (8 weeks), a p-inulin treatment phase (12 weeks), and a post treatment phase (8 weeks) of the study...
March 2024: KI Reports
#20
REVIEW
Muhammad Vaseem Shaikh, Stefan Custers, Alisha Anand, Petar Miletic, Chitra Venugopal, Sheila K Singh
Despite major advances in health care including improved diagnostic tools, robust chemotherapeutic regimens, advent of precision, adjuvant and multimodal therapies, there is a major proportion of patients that still go on to experience tumor progression and recurrence. Cancer stem cells (CSCs) are shown to be responsible for tumor persistence and relapse. This subpopulation of cancer cells possess normal stem cell like traits of self-renewal, proliferation, and multilineage differentiation. Currently, they are isolated and enriched based on the cell surface markers that can be detected and sorted through fluorescence and magnetic-based cell sorting...
2024: Methods in Molecular Biology
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