580,267 results match your criteria trial analysis

Pilot evaluation of a consumer wearable device to assess sleep in a clinical polysomnography trial of suvorexant for treating insomnia in patients with Alzheimer's disease.

J Sleep Res 2021 Aug 2:e13328. Epub 2021 Aug 2.

Merck & Co., Inc., Kenilworth, NJ, USA.

The orexin receptor antagonist suvorexant was previously reported to significantly improve total sleep time (TST), by 28 min per night versus placebo after 4 weeks, in a sleep laboratory polysomnography (PSG) study of patients with Alzheimer's disease and insomnia. The study included an exploratory evaluation of a consumer-grade wearable "watch" device for assessing sleep that we report on here. Participants who met diagnostic criteria for both probable Alzheimer's disease dementia and insomnia were randomized to suvorexant 10-20 mg (N = 142) or placebo (N = 143) in a double-blind, 4-week trial. Read More

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Incubation trial indicated the earthworm intestinal bacteria as promising biodigestor for mitigating tetracycline resistance risk in anthropogenic disturbed forest soil.

Sci Total Environ 2021 Jul 30;798:149337. Epub 2021 Jul 30.

Soil Ecology Lab, College of Resources and Environmental Science, Nanjing Agricultural University, Nanjing 210095, China; Key Laboratory of Plant Immunity, Jiangsu Collaborative Center for Solid Organic Waste Resource Utilization, Nanjing Agricultural University, Nanjing 210095, China.

The continuous input of antibiotics due to frequent anthropogenic activities have increased the dissemination risk of antibiotic resistance genes (ARGs) in forest soil. As soil engineers, it remains unclear whether earthworm intestinal microbial communities might play a role in controlling the ARG proliferation in forest soil. This study collected forest soil in the Yangtze River Delta, China, and its resident Metaphire guillelmi to investigate the interaction between tetracycline (50 μg kg) and the bacteria in worm gut and soil. Read More

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Impact of ozone exposure on heart rate variability and stress hormones: A randomized-crossover study.

J Hazard Mater 2021 Jul 26;421:126750. Epub 2021 Jul 26.

Department of Environmental Health, School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, P.O. Box 249,130 Dong-An Road, Shanghai 200032, China; Children's Hospital of Fudan University, National Center for Children's Health, Shanghai, China. Electronic address:

The biological mechanisms underlying the associations between atmospheric ozone exposure and adverse cardiometabolic outcomes are yet to be identified. Imbalanced autonomic nervous system (ANS) as well as activations of the sympatho-adrenomedullary (SAM) and hypothalamic-pituitary-adrenal (HPA) axes are among possible early biological responses triggered by ozone, and may eventually lead to cardiometabolic abnormalities. To determine whether acute ozone exposure causes ANS imbalance and increases the secretion of neuroendocrine stress hormones, we conducted a randomized, double-blind, crossover trial, under controlled 2-hour exposure to either ozone (200 ppb) or clean air with intermittent exercise among 22 healthy young adults. Read More

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Machine learning applied to over 900 3D printed drug delivery systems.

J Control Release 2021 Jul 30. Epub 2021 Jul 30.

Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, UK; FabRx Ltd., Henwood House, Henwood, Ashford, Kent, England TN24 8DH, UK; Departamento de Farmacología, Farmacia y Tecnología Farmacéutica, I+D Farma (GI-1645), Facultad de Farmacia, Health Research Institute of Santiago de Compostela (IDIS), Universidade de Santiago de Compostela, 15782, Spain. Electronic address:

Three-dimensional printing (3DP) is a transformative technology that is advancing pharmaceutical research by producing personalized drug products. However, advances made via 3DP have been slow due to the lengthy trial-and-error approach in optimization. Artificial intelligence (AI) is a technology that could revolutionize pharmaceutical 3DP through analyzing large datasets. Read More

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Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials.


Lancet Oncol 2021 Aug;22(8):1139-1150

Background: Trastuzumab targets the extracellular domain of the HER2 protein. Adding trastuzumab to chemotherapy for patients with early-stage, HER2-positive breast cancer reduces the risk of recurrence and death, but is associated with cardiac toxicity. We investigated the long-term benefits and risks of adjuvant trastuzumab on breast cancer recurrence and cause-specific mortality. Read More

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Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study.

Lancet Oncol 2021 Jul 30. Epub 2021 Jul 30.

Sarah Cannon Research Institute, Nashville, TN, USA; Tennessee Oncology, Nashville, TN, USA.

Background: Systemic therapies for metastatic biliary tract cancers are few, and patients have a median overall survival of less than 1 year. MyPathway evaluates the activity of US Food and Drug Administration-approved therapies in non-indicated tumours with potentially actionable molecular alterations. In this study, we present an analysis of patients with metastatic biliary tract cancers with HER2 amplification, overexpression, or both treated with a dual anti-HER2 regimen, pertuzumab plus trastuzumab, from MyPathway. Read More

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Neuropathological findings from COVID-19 patients with neurological symptoms argue against a direct brain invasion of SARS-CoV-2: a critical systematic review.

Eur J Neurol 2021 Aug 2. Epub 2021 Aug 2.

IRCCS Mondino Foundation, Pavia, Italy.

Background: Neuropathological studies can elucidate the mechanisms of nervous system damage associated with SARS-CoV-2 infection. Despite literature on this topic is rapidly expanding, correlations between neurological symptoms and brain pathology findings in COVID-19 patients remain largely unknown.

Methods: We performed a systematic literature review on neuropathological studies in COVID-19, including 438 patients from 45 papers published by April 22, 2021. Read More

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Effectiveness of mindfulness-based interventions for people with dementia and mild cognitive impairment: A meta-analysis and implications for future research.

PLoS One 2021 2;16(8):e0255128. Epub 2021 Aug 2.

Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.

Objective: To assess the effectiveness of mindfulness-based interventions on people with dementia and mild cognitive impairment.

Methods: We searched several electronic databases, namely Cochrane Library, EMBASE, and MEDLINE with no limitations for language or document type (last search: 1 February 2020). Randomized controlled trials of mindfulness-based interventions for people with dementia and mild cognitive impairment compared to active-control interventions, waiting lists, or treatment as usual were included. Read More

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Time Trend of the Sensitivity of the Pneumococcal Urinary Antigen Test for Diagnosing Pneumococcal Community-Acquired Pneumonia: An Analysis of 15-Year, Prospective Cohort Data.

Infect Dis Ther 2021 Aug 2. Epub 2021 Aug 2.

Department of Respiratory Medicine, Ohara Healthcare Foundation, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama, 710-8602, Japan.

Introduction: Whether the sensitivity of the BinaxNOW Streptococcus pneumoniae urinary antigen test kit (BinaxNOW), adjusted by some variables including vital signs, laboratory examinations and pneumonia severity, has been decreasing is unknown. The aim of the present study was to investigate whether BinaxNOW sensitivity has decreased recently and to identify the predictors of the BinaxNOW result, including the time trend.

Methods: This prospective cohort study enrolled consecutive patients with pneumococcal community-acquired pneumonia who were hospitalised at Kurashiki Central Hospital from January 2001 to December 2015. Read More

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Can MRI pelvimetry predict the technical difficulty of laparoscopic rectal cancer surgery?

Int J Colorectal Dis 2021 Aug 2. Epub 2021 Aug 2.

Surgical Outcomes Research Centre (SOuRCe), Sydney, Australia.

Purpose: Selection of an open or minimally invasive approach to total mesorectal excision (TME) is generally based on surgeon preference and an intuitive assessment of patient characteristics but there consensus on criteria to predict surgical difficulty. Pelvimetry has been used to predict the difficult surgical pelvis, typically using only bony landmarks. This study aimed to assess the relationship between pelvic soft tissue measurements on preoperative MRI and surgical difficulty. Read More

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Effects of intrathecal opioids on cesarean section: a systematic review and Bayesian network meta-analysis of randomized controlled trials.

J Anesth 2021 Aug 2. Epub 2021 Aug 2.

Department of Anesthesiology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan.

Purpose: We aimed to compare the beneficial and harmful effects of opioids used as adjuncts to local anesthetics in patients undergoing cesarean section under spinal anesthesia.

Methods: We searched electronic databases and ClinicalTrials.gov from their inception until March, 2021 without language restrictions. Read More

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Association of Sodium Thiosulfate With Risk of Ototoxic Effects From Platinum-Based Chemotherapy: A Systematic Review and Meta-analysis.

JAMA Netw Open 2021 Aug 2;4(8):e2118895. Epub 2021 Aug 2.

Department of Otolaryngology - Head and Neck Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.

Importance: Platinum-induced ototoxic effects are a significant issue because platinum-based chemotherapy is one of the most commonly used therapeutic medications. Sodium thiosulfate (STS) is considered a potential otoprotectant for the prevention of platinum-induced ototoxic effects that functions by binding the platinum-based agent, but its administration raises concerns regarding the substantial attenuation of the antineoplastic outcome associated with platinum.

Objective: To evaluate the association between concurrent STS and reduced risk of ototoxic effects among patients undergoing platinum-based chemotherapy and to evaluate outcomes, including event-free survival, overall survival, and adverse outcomes. Read More

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Direct to Angiography Suite Without Stopping for Computed Tomography Imaging for Patients With Acute Stroke: A Randomized Clinical Trial.

JAMA Neurol 2021 Aug 2. Epub 2021 Aug 2.

Unitat d'Ictus, Hospital Universitari Vall d'Hebron, Barcelona, Spain.

Importance: Direct transfer to angiography suite (DTAS) for patients with suspected large vessel occlusion (LVO) stroke has been described as an effective and safe measure to reduce workflow time in endovascular treatment (EVT). However, it is unknown whether DTAS improves long-term functional outcomes.

Objective: To explore the effect of DTAS on clinical outcomes among patients with LVO stroke in a randomized clinical trial. Read More

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Depression Outcomes Among Patients Treated With Fluoxetine for Stroke Recovery: The AFFINITY Randomized Clinical Trial.

JAMA Neurol 2021 Aug 2. Epub 2021 Aug 2.

The George Institute for Global Health, Faculty of Medicine, The University of New South Wales, Camperdown, New South Wales, Australia.

Importance: One in 3 adults experiences clinically significant symptoms of depression during the first year after a stroke, but evidence to support the use of antidepressants in this population remains scant.

Objective: To investigate whether daily treatment with 20 mg of fluoxetine hydrochloride reduces the proportion of people affected by clinically significant symptoms of depression after stroke.

Design, Setting, And Participants: In this secondary analysis of the Assessment of Fluoxetine in Stroke Recovery parallel-group, randomized (1:1 assignment), double-blind, placebo-controlled clinical trial, 1221 participants in Australia, New Zealand, and Vietnam were recruited between January 11, 2013, and June 30, 2019, and were followed up for 6 months. Read More

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Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial.

JAMA Intern Med 2021 Aug 2. Epub 2021 Aug 2.

Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.

Importance: Lower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested.

Objective: To investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability. Read More

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Four-year outcomes of a single-center experience with coronary everolimus-eluting bioresorbable scaffolds.

Minerva Cardiol Angiol 2021 Aug 2. Epub 2021 Aug 2.

Division of Cardiology, Department of Medical Biotechnologies, University of Siena, Siena, Italy.

Background: Bioresorbable scaffolds (BRS) have been introduced to overcome the limitations of drug-eluting stents and the ABSORB (Everolimus-eluting BRS, Abbott Vascular, Santa Clara, CA) was the most extensively tested. Nevertheless, major RCTs reported higher rates of target lesion failures and BRS thrombosis at 3 years follow-up, bringing to the withdrawing of the device from the market. It has been suggested that a better lesions selection and an optimized implantation technique could mitigate the displayed adverse results. Read More

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Association between dynamic dose increases of buprenorphine for treatment of opioid use disorder and risk of relapse.

Addiction 2021 Aug 2. Epub 2021 Aug 2.

Department of Psychiatry, School of Medicine, Columbia University, and New York State Psychiatric Institute, New York, New York.

Background And Aims: Dynamic, adaptive pharmacologic treatment for opioid use disorder (OUD) has been previously recommended over static dosing to prevent relapse, and is aligned with personalized medicine. However, there has been no quantitative evidence demonstrating its advantage. Our objective was to estimate the extent to which a hypothetical intervention that increased buprenorphine dose in response to opioid use would affect risk of relapse over 24 weeks of follow-up. Read More

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Using implementation intentions to prevent relapse after remission from psychological treatment for depression: The SMArT intervention.

Psychother Res 2021 Aug 2:1-12. Epub 2021 Aug 2.

Bradford District Care NHS Foundation Trust, Shipley, UK.

Objective: To provide evidence of the effectiveness of a brief relapse prevention intervention using implementation intentions (Self-Management after Therapy, SMArT), following remission from depression and to identify effective relapse prevention strategies.

Method: The SMArT intervention was provided to 107 patients who were recovered after psychological therapy for depression. Relapse events were calculated as reliable and clinically significant increases in PHQ-scores. Read More

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A randomized controlled trial of glycopyrrolate administered by metered dose inhaler in patients with uncontrolled asthma despite ICS/LABA treatment.

J Asthma 2021 Aug 1:1-13. Epub 2021 Aug 1.

Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.

Objective: To evaluate the efficacy and safety of three doses of glycopyrrolate metered dose inhaler (GP MDI) in patients with uncontrolled asthma despite treatment with inhaled corticosteroid/long-acting β-agonists (ICS/LABA) with or without tiotropium, to characterize the benefit of triple therapy.

Method: This phase II/III, double-blind study randomized patients to 24 weeks' treatment with twice-daily GP MDI 36 µg, 18 µg, 9 µg, or placebo MDI (all delivered Aerosphere inhalers), or once-daily open-label tiotropium 2.5 µg. Read More

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Comparing total medical expenditure between patients receiving direct oral anticoagulants vs warfarin for the treatment of atrial fibrillation: evidence from VA-Medicare dual enrollees.

J Manag Care Spec Pharm 2021 Aug;27(8):1056-1066

Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System, Boston, MA, and Department of Surgery, Boston University, Boston, MA.

Direct oral anticoagulants (DOACs) are an alternative to warfarin for treatment of atrial fibrillation (AF). Evidence demonstrating the efficacy and safety of DOACs has primarily been from clinical trial settings. The real-world effectiveness of DOACs in specific nontrial populations that differ in age, comorbidity burden, and socioeconomic status is unclear. Read More

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Novel epigenetic link between gestational diabetes mellitus and macrosomia.

Epigenomics 2021 Aug 2. Epub 2021 Aug 2.

Center for Global Oncology, Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, IL, 60611, USA.

Examine maternal gestational diabetes mellitus (GDM), macrosomia and DNA methylation in candidate genes , , , , , ,  and . 1145 Children (572 GDM cases and 573 controls) from The Tianjin GDM study, including 177 with macrosomia, had blood DNA collection at median age 5.9 (range: 3. Read More

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Vitamin D supplementation and risk of falling: outcomes from the randomized, placebo-controlled D-Health Trial.

J Cachexia Sarcopenia Muscle 2021 Aug 1. Epub 2021 Aug 1.

Population Health Department, QIMR Berghofer Medical Research Institute, Brisbane, Australia.

Background: Falls cause considerable morbidity and mortality in older people. It is unclear how vitamin D supplementation affects falls risk, particularly when taken at high doses. We sought to determine whether monthly high-dose vitamin D supplementation reduces risk and incidence of falls. Read More

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Degree of Preservation of Neurovascular Bundles in Radical Prostatectomy and Recurrence of Prostate Cancer.

Eur Urol Open Sci 2021 Aug 19;30:25-33. Epub 2021 Jun 19.

Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Background: Reports on possible benefits for continence with nerve-sparing (NS) radical prostatectomy have expanded the indications beyond preservation of erectile function. It is unclear whether NS surgery affects oncological outcomes.

Objective: To determine whether the degree of NS during radical prostatectomy influences oncological outcomes. Read More

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Pigtail Suture Stents Significantly Reduce Stent-related Symptoms Compared to Conventional Double J Stents: A Prospective Randomized Trial.

Eur Urol Open Sci 2021 Jul 10;29:1-9. Epub 2021 May 10.

Department of Urology, Città della Salute e della Scienza, Molinette University Hospital, Turin, Italy.

Background: Double J (DJ) ureteral stents are commonly inserted after ureteroscopy (URS) procedures for stone treatment. However, stent-related symptoms are still a major issue.

Objective: To determine whether a commercially available pigtail suture stent (PSS) can reduce stent-related symptoms compared to a conventional DJ stent after uncomplicated URS. Read More

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Estetrol Cotreatment of Androgen Deprivation Therapy in Infiltrating or Metastatic, Castration-sensitive Prostate Cancer: A Randomized, Double-blind, Phase II Trial (PCombi).

Eur Urol Open Sci 2021 Jun 6;28:52-61. Epub 2021 May 6.

Andros Clinics, Arnhem, The Netherlands.

Background: Androgen deprivation therapy (ADT) for prostate cancer with luteinizing hormone-releasing hormone (LHRH) agonists can be improved.

Objective: To assess safety, the frequency and severity of hot flushes (HFs), bone health, and antitumor effects of high-dose estetrol (HDE4) when combined with ADT.

Design Setting And Participants: A phase II, double-blind, randomized, placebo-controlled study was conducted in advanced prostate cancer patients requiring ADT (the PCombi study). Read More

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Oligorecurrent Prostate Cancer and Stereotactic Body Radiotherapy: Where Are We Now? A Systematic Review and Meta-analysis of Prospective Studies.

Eur Urol Open Sci 2021 May 16;27:19-28. Epub 2021 Mar 16.

Division of Radiation Oncology, IEO European Institute of Oncology IRCCS, Milan, Italy.

Context: The optimal management of oligometastatic prostate cancer (PCa) is still debated.

Objective: The purpose of the present systematic review and meta-analysis is to collect the available evidence to date to better define the role of stereotactic body radiotherapy (SBRT) in selected patients with oligorecurrent PCa.

Evidence Acquisition: Study methodology complied with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA). Read More

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Multicentre International Study for the Prevention with iAluRil of Radio-induced Cystitis (MISTIC): A Randomised Controlled Study.

Eur Urol Open Sci 2021 Apr 23;26:45-54. Epub 2021 Feb 23.

IRCCS Humanitas Research Hospital, via Manzoni 56, 20089 Rozzano, Milan, Italy.

Background: Radiation-induced cystitis is a common side effect of radiotherapy (RT) to the pelvic area. Hyaluronic acid (HA) and chondroitin sulfate (CS) are components of the urothelial mucosa and positive results have been obtained for intravesical HA/CS instillations for the treatment of urinary tract infections and bladder pain syndrome. HA/CS may also have a protective effect against RT bladder toxicity. Read More

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