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JOURNAL ARTICLE
Pietro Gregori, Nicola Maffulli, Joseph Abboud, Pierangelo Za, Giancarlo Giurazza, Giuseppe Francesco Papalia, Augusto Ferrini, Edoardo Franceschetti
BACKGROUND: Patients undergoing surgery for Superior-Labrum-anterior-to-posterior (SLAP) lesions are often worried about their return to sport performance. This systematic review determined the rate of return to sport and return to sport at the previous level (RTSP) after surgery for SLAP lesion. MATERIALS AND METHODS: The PRISMA guidelines were followed. Meta-analysis of data through forest plot projections was conducted. Studies were divided and analyzed according to the type of interventions (isolated slap repair or SLAP repair with rotator cuff debridement and biceps tenodesis)...
March 1, 2024: Sports Medicine and Arthroscopy Review
#2
REVIEW
Philip Heesen, Malgorzata Roos
BACKGROUND: The successful completion of clinical trials ultimately depends on realistic recruitment predictions. Statistical methods for recruitment prediction implemented in a free-of-charge open-source software could be routinely used by researchers worldwide to design clinical trials. However, the availability of such software implementations is currently unclear. METHODS: Two independent reviewers conducted a systematic review following PRISMA guidelines. Eligible articles included English publications focused on statistical methods for recruitment prediction and monitoring that referred to software implementations...
June 2024: Contemporary Clinical Trials Communications
#3
JOURNAL ARTICLE
Ana M Aparicio, Rebecca S S Tidwell, Shalini S Yadav, Jiun-Sheng Chen, Miao Zhang, Jingjing Liu, Shuai Guo, Patrick G Pilie, Yao Yu, Xingzhi Song, Haswanth Vundavilli, Sonali Jindal, Keyi Zhu, Paul V Viscuse, Justin M Lebenthal, Andrew W Hahn, Rama Soundararajan, Paul G Corn, Amado J Zurita, Sumit K Subudhi, Jianhua Zhang, Wenyi Wang, Chad Huff, Patricia Troncoso, James P Allison, Padmanee Sharma, Christopher J Logothetis
PURPOSE: To determine the efficacy and safety of risk-adapted combinations of androgen signaling inhibitors and inform disease classifiers for metastatic castration-resistant prostate cancers (mCRPC). EXPERIMENTAL DESIGN: In a modular, randomized phase II trial, 192 men were treated with 8 weeks of abiraterone acetate, prednisone and apalutamide (AAPA; Module 1), then allocated to Modules 2 or 3 based on Satisfactory (≥50% PSA decline from baseline and <5 CTC/7...
April 29, 2024: Clinical Cancer Research
#4
JOURNAL ARTICLE
Shuhao Xu, Grady G Nguyen, Jack T Naritomi, Hema M Kopalle, Brian A Yee, Katherine L Rothamel, Evan A Boyle, Gene W Yeo
Here, we present a protocol for using Skipper, a pipeline designed to process crosslinking and immunoprecipitation (CLIP) data into annotated binding sites. We describe steps for partitioning annotated transcript regions and fitting data to a beta-binomial model to call windows of enriched binding. From raw CLIP data, we detail how users can map reproducible RNA-binding sites to call enriched windows and perform downstream analysis. This protocol supports optional customizations for different use cases. For complete details on the use and execution of this protocol, please refer to Boyle et al...
April 25, 2024: STAR protocols
#5
REVIEW
Koji Kono, Shotaro Nakajima, Kosaku Mimura
The biomarker-oriented chemo-immunotherapy is useful and promising in the development of new anticancer agents, since the responders can be enriched by selecting patients with biomarkers. Compared to colorectal and lung cancers, the development of biomarker-driven molecular-targeted therapeutics for gastric cancers has been straggled. However, several new biomarkers in gastric cancers have been discovered and clinical trials in enrichment design with certain biomarkers have been conducted. Therefore, there are currently several treatment options to treat gastric cancer patients based on individual biomarker-oriented strategies...
April 22, 2024: International Journal of Clinical Oncology
#6
JOURNAL ARTICLE
Tahreem Arshad, Haji Muhammad Shoaib Khan, Kashif-Ur-Rehman Khan, Abdulaziz S Al-Roujayee, Mohamed Mohany, Maqsood Ahmad, Sana Maryam, Muhammad Bilal Akram, Hasnain Shaukat, Umair Khursheed, Mourad A M Aboul-Soud
The bioactive extracts of traditional medicinal plants are rich in polyphenols and help to rejuvenate skin. The study was designed to assess the skin rejuvenating effects of a stable cream enriched with 4% I. argentea (IaMe) extract. The quantity of polyphenols by spectrophotometric methods was TPC, 101.55 ± 0.03 mg GAE/g and total flavonoid content; 77.14 ± 0.13 mg QE/g, while HPLC-PDA revealed gallic acid; 4.91, chlorogenic acid 48.12, p-coumaric acid 0.43, and rutin 14.23 μg/g...
2024: Frontiers in Pharmacology
#7
JOURNAL ARTICLE
Pietro Ameri, Valentina Mercurio, Piero Pollesello, Markus S Anker, Johannes Backs, Antoni Bayes-Genis, Barry A Borlaug, Daniel Burkhoff, Sergio Caravita, Stephen Y Chan, Frances de Man, George Giannakoulas, Aránzazu González, Marco Guazzi, Paul M Hassoun, Anna R Hemnes, Cristoph Maack, Brendan Madden, Vojtech Melenovsky, Oliver J Müller, Zoltan Papp, Soni Savai Pullamsetti, Peter P Rainer, Margaret M Redfield, Stuart Rich, Gabriele G Schiattarella, Hall Skaara, Kostantinos Stellos, Ryan J Tedford, Thomas Thum, Jean Luc Vachiery, Peter van der Meer, Sophie Van Linthout, Piotr Pruszczyk, Petar Seferovic, Andrew J S Coats, Marco Metra, Giuseppe Rosano, Stephan Rosenkranz, Carlo Gabriele Tocchetti
Pulmonary hypertension (PH) associated with left heart failure (LHF) (PH-LHF) is one of the most common causes of PH. It directly contributes to symptoms and reduced functional capacity and negatively affects right heart function, ultimately leading to a poor prognosis. There are no specific treatments for PH-LHF, despite the high number of drugs tested so far. This scientific document addresses the main knowledge gaps in PH-LHF with emphasis on pathophysiology and clinical trials. Key identified issues include better understanding of the role of pulmonary venous versus arteriolar remodelling, multidimensional phenotyping to recognize patient subgroups positioned to respond to different therapies, and conduct of rigorous pre-clinical studies combining small and large animal models...
April 19, 2024: European Journal of Heart Failure
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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