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Rely trial

Charlotte L Hall, Marilyn James, Sue Brown, Jennifer L Martin, Nikki Brown, Kim Selby, Julie Clarke, Hena Vijayan, Boliang Guo, Kapil Sayal, Chris Hollis, Madeleine J Groom
INTRODUCTION: Attention-deficit hyperactivity disorder (ADHD) is characterised by symptoms of inattention, hyperactivity and impulsivity. To improve outcomes, the National Institute for Health and Care Excellence ADHD guidelines recommend regular monitoring of symptoms when children commence medication. However, research suggests that routine monitoring rarely happens, and clinicians often rely on subjective information such as reports from parents and teachers to ascertain improvement...
February 15, 2018: BMJ Open
Jean-Baptiste Woillard, Franck Saint-Marcoux, Jean Debord, Anders Åsberg
Due to a high inter-individual variability in its pharmacokinetics, tacrolimus dose individualization is mandatory. Even though the expert opinion has defined the area under the curve (AUC) as the best marker to use when performing dose adjustment of tacrolimus, most centres only use trough levels. Multiple targets have been proposed for this parameter and physicians rely largely on their personal experience when making a decision about dose adjustment. Several population pharmacokinetics models (POPPK) allowing AUC determination have been developed, but only a few are actually used in routine practice for dose individualization...
February 13, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Zilei Liu, Jie Li, Suhua Li, Gencheng Li, K Barry Sharpless, Peng Wu
Sulfur(VI) Fluoride Exchange (SuFEx) is a new family of click chemistry transformations which relies on readily available materials to produce compounds bearing the S VI -F motif. The potential of SuFEx in drug discovery has just started to be explored. We report the first method of SuFEx chemistry for the conversion of phenolic compounds to their respective arylfluorosulfate derivatives in situ in 96-well plates. This method is compatible with automated synthesis and screening to quickly assess the biological activities of the in situ generated, crude products...
February 16, 2018: Journal of the American Chemical Society
Darya L Zabelina, Giorgio Ganis
Two studies used event-related potentials (ERPs) to examine whether and how divergent thinking and creative achievement are linked to attentional flexibility and cognitive control as indexed by response times and by the amplitude of the anterior N2 ERP component. Both experiments used an oddball paradigm in which participants viewed hierarchical letter stimuli and identified target letters in frequent and rare target trials. The successful identification of targets required attentional flexibility when switching levels of attention (from the frequent global to the rare local attentional level, or vice-versa)...
February 12, 2018: Neuropsychologia
Lisa M Potter, Angela Q Maldonado, Krista L Lentine, Mark A Schnitzler, Zidong Zhang, Gregory P Hess, Edward Garrity, Bertram L Kasiske, David A Axelrod
Transplant immunosuppressants are often used off-label due to insufficient randomized prospective trial data to achieve organ-specific US Food and Drug Administration (FDA) approval. Transplant recipients who rely on Medicare Part D for immunosuppressant drug coverage are vulnerable to coverage denial for off-label prescriptions, unless use is supported by Centers for Medicare & Medicaid Services (CMS)-approved compendia. An integrated data set including national transplant registry data and 3 years of dispensed pharmacy records was used to identify the prevalence of immunosuppression use that is both off-label and not supported by CMS-approved compendia...
February 15, 2018: American Journal of Transplantation
Sanjay Bhandari, Pinky Jha, Abhishek Thakur, Abhipsa Kar, Harrison Gerdes, Thangam Venkatesan
Cyclic-vomiting syndrome (CVS) is a chronic functional gastrointestinal disorder characterized by recurrent episodes of nausea and vomiting. Although once thought to be a pediatric disorder, there has been a considerable increase in recognition of CVS in adults. The exact pathogenesis is unknown and several theories have been proposed. Migraine and CVS share a similar pathophysiology as suggested by several studies. Since there are no specific biomarkers available for this disorder, physicians should rely on Rome criteria for the diagnosis...
February 13, 2018: Clinical Autonomic Research: Official Journal of the Clinical Autonomic Research Society
Jing Zhang, Chia-Wen Ko, Lei Nie, Yong Chen, Ram Tiwari
Meta-analysis of interventions usually relies on randomized controlled trials. However, when the dominant source of information comes from single-arm studies, or when the results from randomized controlled trials lack generalization due to strict inclusion and exclusion criteria, it is vital to synthesize both sources of evidence. One challenge of synthesizing both sources is that single-arm studies are usually less reliable than randomized controlled trials due to selection bias and confounding factors. In this paper, we propose a Bayesian hierarchical framework for the purpose of bias reduction and efficiency gain...
January 1, 2018: Statistical Methods in Medical Research
Feifei Teng, Madhava Aryal, Jae Lee, Choonik Lee, Xioajin Shen, Peter Hawkins, Michelle Mierzwa, Avraham Eisbruch, Yue Cao
PURPOSE: Positron emission tomography with 18 F-deoxyglucose (FDG), dynamic contrast-enhanced magnetic resonance imaging (MRI), and diffusion-weighted MRI each identify unique risk factors for treatment outcomes in head and neck cancer (HNC). Clinical trials in HNC largely rely on a single imaging modality to define targets for boosting. This study aimed to investigate the spatial correspondence of FDG uptake, perfusion, and the apparent diffusion coefficient (ADC) in HNC and their response to chemoradiation therapy (CRT) and to determine the implications of this overlap or lack thereof for adaptive boosting...
December 21, 2017: International Journal of Radiation Oncology, Biology, Physics
Helen K Reddel
Asthma management is in an intriguing phase, with acceptance of asthma as a heterogeneous condition with different phenotypes and underlying mechanisms and the potential for personalized asthma care, in parallel with increasing evidence about the population-level impact of basic strategies to increase access to medicines and improve inhaler technique and adherence. These changes have been facilitated by a more comprehensive view of evidence, including both randomized controlled trials with high internal validity and pragmatic and observational studies with high generalizability to patients in clinical practice...
February 2018: Seminars in Respiratory and Critical Care Medicine
Pau Serra, Pere Santamaria
Autoimmune diseases are caused by antigenically complex immune responses of the adaptive and innate immune system against specific cells, tissues or organs. Antigen-specific approaches for induction of immune tolerance in autoimmunity, based on the use of antigenic peptides or proteins, have failed to deliver the desired therapeutic results in clinical trials. These approaches, which are largely relying on triggering clonal anergy and/or deletion of defined autoreactive specificities, do not address the overwhelming antigenic, molecular and cellular complexity of most autoimmune diseases, which involve various immune cells and ever-growing repertoires of antigenic epitopes on numerous self-antigens...
February 10, 2018: European Journal of Immunology
A Scherpereel, M-C Willemin, E Wasielewski, X Dhalluin
INTRODUCTION: Malignant pleural mesothelioma (MPM) is a quite rare cancer, but with increasing incidence, that is usually induced by previous asbestos exposure. Its prognosis is poor and there is no validated curative therapy to date. Surgery of MPM, done only by few expert teams within a multimodal treatment is of limited and still disputed value. The standard treatment of MPM, relying on first-line chemotherapy by combined cisplatin-pemetrexed is often poorly effective, even if combination with bevacizumab anti-VEGF antibodies has slightly improved the results...
February 4, 2018: Revue des Maladies Respiratoires
Francesco Di Gregorio, Martin E Maier, Marco Steinhauser
Errors in human behavior elicit a cascade of brain activity related to performance monitoring and error detection. Whereas the early error-related negativity (Ne/ERN) has been assumed to reflect a fast mismatch or prediction error signal in the medial frontal cortex, the later error positivity (Pe) is viewed as a correlate of conscious error processing. A still open question is whether these components represent two independent systems of error monitoring that rely on different types of information to detect an error...
January 30, 2018: NeuroImage
Cécile Chalouni, Sophia Doll
Antibody-Drug Conjugates (ADCs) are a class of cancer therapeutics that combines antigen specificity and potent cytotoxicity in a single molecule as they are comprised of an engineered antibody linked chemically to a cytotoxic drug. Four ADCs have received approval by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) and can be prescribed for metastatic conditions while around 60 ADCs are currently enrolled in clinical trials. The efficacy of an ADC greatly relies on its intracellular trafficking and processing of its components to trigger tumor cell death...
February 6, 2018: Journal of Experimental & Clinical Cancer Research: CR
Mitchell S Fourman, Adel Mahjoub, Jon B Mandell, Shibing Yu, Jessica C Tebbets, Jared A Crasto, Peter E Alexander, Kurt R Weiss
BACKGROUND: Current preclinical osteosarcoma (OS) models largely focus on quantifying primary tumor burden. However, most fatalities from OS are caused by metastatic disease. The quantification of metastatic OS currently relies on CT, which is limited by motion artifact, requires intravenous contrast, and can be technically demanding in the preclinical setting. We describe the ability for indocyanine green (ICG) fluorescence angiography to quantify primary and metastatic OS in a previously validated orthotopic, immunocompetent mouse model...
January 17, 2018: Clinical Orthopaedics and related Research
Jake X Checketts, Mathew T Sims, Byron Detweiler, Kevin Middlemist, Jaclyn Jones, Matt Vassar
BACKGROUND: The responsibility for ensuring that studies are adequately reported is primarily that of those conducting the study; however, journal policies may influence how thoroughly authors choose to report their research. The use of reporting guidelines and prospective trial registration are promising avenues for ensuring that published studies adhere to the highest methodological standards. The purpose of this study is to evaluate orthopaedic surgery journal policies regarding reporting guidelines and trial registration, and to evaluate the effects that these policies have on adherence to reporting...
February 7, 2018: Journal of Bone and Joint Surgery. American Volume
Gil Zeevi, Dan Tirosh, Joel Baron, Maayan Yitshak Sade, Adi Segal, Reli Hershkovitz
OBJECTIVE: To (a) evaluate the risk for placenta accreta following primary cesarean section (CS), in regard to the stage of labor, the cesarean section was taken (elective prelabor vs. unplanned during labor); and (b) investigate whether the association between placenta accreta and maternal and neonatal complications is modified by the type of the primary CS. STUDY DESIGN: In a population-based retrospective cohort study, we included all singleton deliveries occurred in Soroka University Medical Center between 1991 and 2015, of women who had a history of a single CS...
February 5, 2018: Archives of Gynecology and Obstetrics
Zobair M Younossi, Maria Stepanova, Nila Rafiq, Linda Henry, Rohit Loomba, Hala Makhlouf, Zachary Goodman
Nonalcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic fatty liver disease (NAFLD). The minimal pathologic criteria for NASH include hepatic steatosis, ballooning degeneration, and lobular inflammation. The resolution of NASH, which relies on the loss of ballooning degeneration, is subject to sampling and observer variability in pathologic interpretation. Ballooning is associated with advanced hepatic fibrosis in cross-sectional studies but is not a predictor of mortality in NAFLD. Fibrosis staging, while still subject to some sampling variability, has less observer variability and is a robust predictor of liver-related mortality in NAFLD...
July 2017: Hepatology Communications
Jiangtao Lin, Xin Zhou, Changzheng Wang, Chuntao Liu, Shaoxi Cai, Mao Huang
The Global Initiative for Asthma (GINA) annual report summarizes the latest evidence for asthma management. GINA recommends stepwise pharmacological treatment, advocating inhaled corticosteroids (ICS) plus rapid, long-acting β2-agonists (LABA) delivered in a single inhaler for maintenance and relief at Steps 3 (moderate persistent asthma requiring 1-2 controllers plus as-needed reliever), 4 (severe persistent asthma requiring ≥2 controllers plus as-needed reliever), and 5 (higher level care and/or add-on treatment)...
February 5, 2018: Expert Review of Respiratory Medicine
Carola F van Eck, Aneet Toor, Michael B Banffy, Ralph A Gambardella
Background: A good patient-surgeon relationship relies on adequate preoperative education and counseling. Several multimedia resources, such as web-based education tools, have become available to enhance aspects of perioperative care. Purpose/Hypothesis: The purpose of this study was to evaluate the effect of an interactive web-based education tool on perioperative patient satisfaction scores after outpatient orthopaedic surgery. It was hypothesized that web-based education prior to outpatient orthopaedic surgery enhances patient satisfaction scores...
January 2018: Orthopaedic Journal of Sports Medicine
Bradley C Leibovich, Christine M Lohse, John C Cheville, Harras B Zaid, Stephen A Boorjian, Igor Frank, R Houston Thompson, William P Parker
BACKGROUND: Predicting oncologic outcomes is important for patient counseling, clinical trial design, and biomarker study testing. OBJECTIVE: To develop prognostic models for progression-free (PFS) and cancer-specific survival (CSS) in patients with clear cell renal cell carcinoma (ccRCC), papillary RCC (papRCC), and chromophobe RCC (chrRCC). DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort review of the Mayo Clinic Nephrectomy registry from 1980 to 2010, for patients with nonmetastatic ccRCC, papRCC, and chrRCC...
February 2, 2018: European Urology
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