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Trials and Tribulations: mHealth Clinical Trials in the COVID-19 Pandemic.

Yearb Med Inform 2021 Apr 21. Epub 2021 Apr 21.

Graduate School of Biomedical Engineering, The University of New South Wales, Sydney, Australia.

Introduction: Mobile phone-based interventions in cardiovascular disease are growing in popularity. A randomised control trial (RCT) for a novel smartphone app-based model of care, named TeleClinical Care - Cardiac (TCC-Cardiac), commenced in February 2019, targeted at patients being discharged after care for an acute coronary syndrome or episode of decompensated heart failure. The app was paired to a digital sphygmomanometer, weighing scale and a wearable fitness band, all loaned to the patient, and allowed clinicians to respond to abnormal readings. Read More

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Aspirin Responsiveness at a Dose of 80 mg and Its Impact on Birth Weight when Used in Twin Pregnancies: The GAP Pilot Randomized Trial.

Am J Perinatol 2021 Apr 21. Epub 2021 Apr 21.

Centre de recherche du Centre Hospitalier, Universiatire de Québec-Université Laval, Axe Santé Reproduction Mère et Enfant, Québec, Canada.

Objective:  Daily aspirin, started in the first trimester of pregnancy, is commonly used for the prevention of preeclampsia and fetal growth restriction in multiple gestation. However, the optimal dose remains controversial and the evidence for the use of aspirin in multiple pregnancies is scarce. We aimed to estimate the impact of 80 mg of aspirin in twin pregnancies. Read More

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[Non-metastatic castration-resistant prostate cancer (M0CRPC) - Apalutamide in high-risk M0CRPC: case reports from the SPARTAN study and the apalutamide compassionate use program].

Aktuelle Urol 2021 Apr 21. Epub 2021 Apr 21.

Universitätsklinikum Münster, Urology, Münster.

The occurrence of distant metastases represents a prognostically unfavourable turning point in non-metastatic castration-resistant prostate cancer (M0CRPC). M0CRPC patients with a short PSA doubling time have a particularly high risk of progression. For a long time, there was no further treatment option for these patients apart from watchful waiting while maintaining classic androgen deprivation therapy (ADT). Read More

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Translucent Zirconium Dioxide and Lithium Disilicate: A 3-Year Follow-up of a Prospective, Practice-Based Randomized Controlled Trial on Posterior Monolithic Crowns.

Int J Prosthodont 2021 Mar-Apr;34(2):163-172

Purpose: To systematically evaluate and compare the clinical performance of lithium disilicate (LDS)- and zirconium dioxide (ZrO)-based ceramic monolithic crowns in the posterior dentition.

Materials And Methods: Treatment was administered by two experienced general dental practitioners in two public dental health care clinics. Forty-four patients received 60 crowns randomized to be either LDS or ZrO and cemented with resin cement. Read More

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TRanexamic Acid In Pediatric Scoliosis Surgery (TRIPSS): A Prospective Randomized Trial Comparing High Dose and Low Dose Tranexamic Acid in Adolescent Idiopathic Scoliosis (AIS) Undergoing Posterior Spinal Fusion Surgery.

Spine (Phila Pa 1976) 2021 Apr 19. Epub 2021 Apr 19.

Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia Department of Orthopaedic Surgery (NOCERAL), Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.

Study Design: Prospective randomized double-blinded trial.

Objective: The objective of this study is to determine the efficacy of high dose versus low dose tranexamic acid (TXA) in adolescent idiopathic scoliosis (AIS) corrective surgery.

Summary Of Background Data: Corrective surgery for AIS is associated with significant blood loss. Read More

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Anal squamous cell carcinoma: standards of care, new data and ongoing clinical trials.

Curr Opin Oncol 2021 Apr 20. Epub 2021 Apr 20.

Medical Oncology Department of Precision Medicine, University of Campania 'Luigi Vanvitelli', Naples, Italy Department of Medical Oncology, Institut Jules Bordet - Université Libre de Bruxelles (ULB), Brussels, Belgium.

Purpose Of Review: To summarize current standards of care, discuss results of recent studies and present ongoing clinical trials for anal squamous cell carcinoma (ASCC).

Recent Findings: Over the last year, no practice changing studies have been reported in the setting of localised ASCC. A number of retrospective analyses, however, have provided practice-informing data, such as those confirming the negative impact of low compliance to chemoradiotherapy (CRT) on patient outcomes. Read More

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Retroperitoneal sarcoma: the Transatlantic Australasian Retroperitoneal Sarcoma Working Group Program.

Curr Opin Oncol 2021 Apr 20. Epub 2021 Apr 20.

Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy Department of Surgery, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA Department of Surgical Oncology, Princess Margaret Cancer Centre/Mount Sinai Hospital, Toronto and Department of Surgery, University of Toronto, Toronto, Ontario, Canada.

Purpose Of The Review: The Transatlantic Australasian Retroperitoneal Sarcoma Working Group (TARPSWG) is a bottom-up clinical network established in 2013 with the goal of improving the care and outcomes of patients with retroperitoneal sarcoma (RPS). Here, we review the knowledge produced by this collaborative effort and examine the future potential of this group.

Recent Findings: TARPSWG has produced retrospective studies focused on patients with primary and recurrent RPS allowing a better understanding of patient prognosis, treatment outcomes and tumor biology. Read More

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Invariability of EEG error-related potentials during continuous feedback protocols elicited by erroneous actions at predicted or unpredicted states.

J Neural Eng 2021 Apr 21. Epub 2021 Apr 21.

ECE & Neurology, University of Texas at Austin, 2501 Speedway, Austin, Texas, 78712-1139, UNITED STATES.

When humans perceive an erroneous action, an EEG error related potential (ErrP) is elicited as a neural response. ErrPs have been largely investigated in discrete feedback protocols, where actions are executed at discrete steps, to enable seamless brain-computer interaction. However, there are only a few studies that investigate ErrPs in continuous feedback protocols. Read More

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Ten women's decision-making experiences in threatened preterm labour: Qualitative findings from the EQUIPTT trial.

Sex Reprod Healthc 2021 Mar 29;29:100611. Epub 2021 Mar 29.

Department of Women and Children's Health, School of Life Course Sciences, King's College London, 10(th) Floor North Wing, St Thomas' Hospital, Westminster Bridge Road, SE1 7EH, United Kingdom.

Background: Clinical triage of women in threatened preterm labour (TPTL) could be improved through utilising the QUiPP App, as symptoms alone are poor predictors of early delivery. As most women in TPTL ultimately deliver at term, they must weigh this likelihood with their own personal considerations, and responsibilities. The importance of personal considerations was highlighted by the 2015 Montgomery ruling, and the significance of shared decision-making. Read More

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Changes in salivary oxytocin after stroking in dogs: Validation of two assays for its assessment.

Res Vet Sci 2021 Apr 13;136:527-534. Epub 2021 Apr 13.

Interdisciplinary Laboratory of Clinical Analysis of the University of Murcia (Interlab-UMU), Regional Campus of International Excellence 'Campus Mare Nostrum', University of Murcia, Campus de Espinardo s/n, 30100 Espinardo, Murcia, Spain.

Oxytocin is currently of high interest as a biomarker of welfare and stress in humans and animals. The purpose of this study was to validate two new assays (one using a monoclonal antibody and the other using a polyclonal antibody) for the oxytocin measurement in the saliva of dogs. For this purpose, an analytical validation was performed, and these assays were applied in an experimental trial in which dogs were stroked by their owners. Read More

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Study of the SARS-CoV-2-specific immune T-cell responses in COVID-19-positive cancer patients.

Eur J Cancer 2021 Mar 26;150:1-9. Epub 2021 Mar 26.

INSERM, EFS BFC, UMR1098 RIGHT, University of Bourgogne Franche-Comté, France; Department of Medical Oncology, Biotechnology and Immune-oncology Platforme, University Hospital of Besançon, France; Department of Pharmacy, University Hospital of Besançon, France.

Background: Cancer patients are considered highly vulnerable to the COVID-19 pandemic. However, delaying cancer-specific therapies could have a deleterious effect on survival. The potential suppressive effects of chemotherapies or cancer-related microenvironment raised the question on how cancer patients' immune system responds to SARS-CoV-2 virus. Read More

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Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19.

N Engl J Med 2021 Apr 21. Epub 2021 Apr 21.

From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, G. Shukarev, G. Scheper, M.L.G., H.S., J.V.H., M.D.); South African Research Council, Cape Town, South Africa (G.G.); Janssen Research and Development, Beerse, Belgium (A.V., C.T., H.F., B.S., K.O., M.F.R., N.C., T.T., K.H., J.R.G., F.S.); Janssen Research and Development, Spring House, PA (V.C.); Evandro Chagas National Institute of Infectious Diseases-Fiocruz, Rio de Janeiro (B.G.); the University of Alabama at Birmingham, Birmingham (P.A.G.); the National Institute of Allergy and Infectious Diseases, Rockville (K.L.T., M.A.M.), Walter Reed Army Institute of Research, Silver Spring (M.L.R.), and the Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore (K.M.N.) - all in Maryland; Biomedical Advanced Research and Development Authority, Washington, DC (J.T.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (D.H.B.); Janssen Research and Development, Raritan, NJ (J. Stoddard); and Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (L.C.).

Background: The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. Read More

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Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer.

N Engl J Med 2021 04;384(16):1529-1541

From the Division of Medical Oncology, Massachusetts General Hospital Cancer Center (A. Bardia), and the Department of Medical Oncology, Dana-Farber Cancer Institute (S.M.T.) - both in Boston; the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles (S.A.H.); the Medical Oncology Department and the Department of Drug Development and Innovation, Institut Curie, Paris (D.L.), Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse (F.D.), and the Department of Medical Oncology, Centre Eugène Marquis, Rennes (V.D.) - all in France; the Department of General Medical Oncology and Multidisciplinary Breast Center, Leuven Cancer Institute, University Hospitals Leuven, Leuven (K.P.), and the Clinical Trials Conduct Unit (P.A.), Institut Jules Bordet-Université Libre de Bruxelles (M.J.P.), Brussels - all in Belgium; the Medical Oncology Department and Breast Cancer Group, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (M.O.), and the International Breast Cancer Center, Quiron Group (J.C.) - all in Barcelona; Magee-Womens Hospital and the Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh (A. Brufsky); Ohio State University Wexner Medical Center, Columbus (S.D.S.); Columbia University Irving Medical Center (K.K.) and Memorial Sloan Kettering Cancer Center (T.T.) - both in New York; Northside Hospital, Atlanta (A.B.Z.); Florida Cancer Specialists, Tampa (R.W.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (F.L.); Rocky Mountain Cancer Centers, Greenwood Village, CO (S.D.); Baylor University Medical Center and Texas Oncology, Dallas (J.O.); Segal Cancer Centre, Jewish General Hospital, Montreal (C.F.); Barts Cancer Institute, Queen Mary University of London, London (P.S.); University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill (L.A.C.); Gianni Bonadonna Foundation, Milan (L.G.); the Department of Medicine and Research, Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Frankfurt, Germany (S.L.); Immunomedics, Morris Plains, NJ (D.M.G., Q.H., M.S.O., L.M.I.); and the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco (H.S.R.).

Background: Patients with metastatic triple-negative breast cancer have a poor prognosis. Sacituzumab govitecan is an antibody-drug conjugate composed of an antibody targeting the human trophoblast cell-surface antigen 2 (Trop-2), which is expressed in the majority of breast cancers, coupled to SN-38 (topoisomerase I inhibitor) through a proprietary hydrolyzable linker.

Methods: In this randomized, phase 3 trial, we evaluated sacituzumab govitecan as compared with single-agent chemotherapy of the physician's choice (eribulin, vinorelbine, capecitabine, or gemcitabine) in patients with relapsed or refractory metastatic triple-negative breast cancer. Read More

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Different clinical entities of the same mutation: a case report of three sisters with Wolfram syndrome and efficacy of dipeptidyl peptidase-4 inhibitor therapy.

J Pediatr Endocrinol Metab 2021 Apr 21. Epub 2021 Apr 21.

Department of Pediatric Endocrinology, Istanbul University-Cerrahpasa Cerrahpasa Faculty of Medicine, Istanbul, Turkey.

Objectives: Wolfram syndrome (WS) is a rarely seen autosomal recessive multisystem neurodegenerative disorder caused by mutations in the gene.

Case Presentation: Three sisters with WS had diabetes mellitus (DM) at 4 years of age and optic atrophy. In addition, the first case had hearing impairment, and the second case had diabetes insipidus and urinary incontinence. Read More

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Tocilizumab in COVID-19 pneumonia: Practical proposals based on a narrative review of randomised trials.

Rev Med Virol 2021 Apr 21:e2239. Epub 2021 Apr 21.

Infectious Disease Department, Nord Franche-Comté Hospital, Montbéliard-Belfort, France.

In this article, we express our opinion about tocilizumab as an effective treatment in coronavirus disease 2019, based on a narrative review and a deep analysis of tocilizumab randomised trial results. Eight trials were included. No one was in favour for controlled arm about main endpoint of death or mechanical ventilation incidence at day 28-30. Read More

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SWOG S1609-A phase 2 basket trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors: A high-grade neuroendocrine neoplasm cohort.

Cancer 2021 Apr 21. Epub 2021 Apr 21.

Moores Cancer Center, University of California at San Diego, La Jolla, California.

Background: The authors previously reported the results of the nonpancreatic neuroendocrine neoplasm cohort of the SWOG S1609 DART (Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors) trial, which permitted all histologic grades and had a 44% overall response rate (ORR) among patients with high-grade disease. Here they sought to validate their findings in a dedicated prospective cohort of high-grade neuroendocrine neoplasms within S1609.

Methods: A prospective, open-label, multicenter, phase 2 clinical trial of ipilimumab plus nivolumab was conducted across multiple rare tumor cohorts. Read More

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Clinical Evaluation of Lithium Disilicate Veneers Manufactured by CAD/CAM Compared with Heat-pressed Methods: Randomized Controlled Clinical Trial.

Oper Dent 2021 Jan;46(1):4-14

Clinical Relevance: Lithium disilicate veneers for esthetic restorations show great accuracy and similarity, regardless of the type of fabrication technique.

Summary: Read More

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January 2021

Effectiveness and cardiac safety of bedaquiline-based therapy for drug-resistant tuberculosis: a prospective cohort study.

Clin Infect Dis 2021 Apr 21. Epub 2021 Apr 21.

Wellcome Centre for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, and Department of Medicine, University of Cape Town, Cape Town, South Africa.

Background: Bedaquiline improves treatment outcomes in patients with rifampin-resistant TB (RR-TB) but prolongs the QT-interval and carries a black-box warning by the U.S. Food and Drug Administration. Read More

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What proportion of people have a follow-up biopsy in randomized trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis.

PLoS One 2021 21;16(4):e0250385. Epub 2021 Apr 21.

Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.

Background And Aim: Trials of treatments for non-alcoholic steatohepatitis require endpoint assessment with liver biopsies. Previous large-scale trials have calculated their sample size expecting high retention but on average did not achieve this. We aimed to quantify the proportion of participants with a valid follow-up biopsy. Read More

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Finding, treating and retaining persons with HIV in a high HIV prevalence and high treatment coverage country: Results from the Botswana Combination Prevention Project.

PLoS One 2021 21;16(4):e0250211. Epub 2021 Apr 21.

Division of Global HIV/AIDS, U.S. Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.

Introduction: The scale-up of Universal Test and Treat has resulted in reductions in HIV morbidity, mortality and incidence. However, healthcare system and personal challenges have impacted the levels of treatment coverage achieved. We implemented interventions to improve linkage to care, retention, viral load (VL) coverage and service delivery, and describe the HIV care cascade over the course of the Botswana Combination Prevention Project (BCPP) study. Read More

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eNose-TB: A trial study protocol of electronic nose for tuberculosis screening in Indonesia.

PLoS One 2021 21;16(4):e0249689. Epub 2021 Apr 21.

Faculty of Medicine, Public Health and Nursing, Center for Tropical Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia.

Background: Even though conceptually, Tuberculosis (TB) is almost always curable, it is currently the world's leading infectious killer. Patients with pulmonary TB are the source of transmission. Approximately 23% of the world's population is believed to be latently infected with TB bacteria, and 5-15% of them will progress at any point in time to develop the disease. Read More

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Experiences of maternity care among women at increased risk of preterm birth receiving midwifery continuity of care compared to women receiving standard care: Results from the POPPIE pilot trial.

PLoS One 2021 21;16(4):e0248588. Epub 2021 Apr 21.

Department of Women and Children's Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.

Background: Midwifery continuity of care models for women at low and mixed risk of complications have been shown to improve women's experiences of care. However, there is limited research on care experiences among women at increased risk of preterm birth. We aimed to explore the experiences of care among women with risk factors for preterm birth participating in a pilot trial (POPPIE) of a midwifery continuity of care model which included a specialist obstetric clinic. Read More

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Nutraceutical Support of Mitochondrial Function Associated With Reduction of Long-term Fatigue and Inflammation.

Altern Ther Health Med 2021 May;27(3):8-18

Objectives: To evaluate the effects of ATP 360, a nutraceutical energy formula, in people experiencing long-term fatigue affecting daily living. To explore the use of ex vivo mitochondrial stress testing to evaluate cellular energy improvements with nutraceutical support.

Study Design: An open-label study design was used with screening for long-term fatigue, scoring 50% or higher on the Piper Fatigue Scale. Read More

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Effects of multi-domain lifestyle interventions on sarcopenia measures and blood biomarkers: secondary analysis of a randomized controlled trial of community-dwelling pre-frail and frail older adults.

Aging (Albany NY) 2021 Mar 19;13(7):9330-9347. Epub 2021 Mar 19.

Gerontology Research Programme, Department of Psychological Medicine, National University Health System, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.

Few studies have comprehensively described changes in blood biomarkers of the physiological responses underlying sarcopenia reduction associated with lifestyle interventions. In this study, we performed secondary analyses of data in a randomized controlled trial of multi-domain lifestyle interventions (6-month duration physical exercise, nutritional enrichment, cognitive training, combination and standard care control) among 246 community-dwelling pre-frail and frail elderly, aged ≥65 years, with and without sarcopenia. Appendicular lean mass (ALM), lower limb strength, gait speed, and blood levels of markers of muscle metabolism, inflammation, anti-oxidation, anabolic hormone regulation, insulin signaling, tissue oxygenation were measured at baseline, 3-month and 6-month post-intervention. Read More

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Usability and Clinical Evaluation of Self-Sampling for SARS-CoV-2 Diagnostic Testing Using Nasal and Saliva Specimens in South Africa: Study Protocol.

JMIR Res Protoc 2021 Mar 9. Epub 2021 Mar 9.

Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington DC, USA, Washington, US.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a coronavirus novel discovered in December 2019 and is currently the cause of a global pandemic. A critical aspect of fighting this pandemic is by obtaining accurate and timeous test results so that positive identified cases can be isolated to reduce the spread. Research has shown that saliva is a promising candidate for SARS-CoV-2 diagnostics because collection is minimally invasive and can reliably be self-administered. Read More

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A Peer-to-Peer Live Streaming Intervention for Children during COVID-19 Home Schooling to Promote Physical Activity and Reduce Anxiety and Eye Strain: Cluster Randomized Controlled Trial.

J Med Internet Res 2021 Apr 14. Epub 2021 Apr 14.

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Room 509, No.7 Jinsui Rd, Zhujiang New Town, Guangzhou, CN.

Background: The COVID-19 pandemic has led to global school closures, and millions of children are confined to online learning at home. As a result, children may be susceptible to anxiety and digital eye strain, highlighting a need for population interventions.

Objective: The objective of our study was to investigate whether a digital behavior change intervention could reduce children's anxiety and digital eye strain while undergoing prolonged home schooling during the COVID-19 pandemic. Read More

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Predictors of Vision-Related Quality of Life After Endothelial Keratoplasty in the Descemet Endothelial Thickness Comparison Trials.

Cornea 2021 Apr;40(4):449-452

*F. I. Proctor Foundation, University of California, San Francisco, CA; †Casey Eye Institute, Oregon Health Sciences University, Portland, OR; ‡Byers Eye Institute, Stanford University, Palo Alto, CA; §Lions VisionGift, Portland, OR; ¶Department of Ophthalmology, University of California, San Francisco, CA; ‖Department of Epidemiology and Biostatistics, University of California, San Francisco, CA; and **Department of Research, Kaiser Permanente Northern California.

Purpose: To determine which baseline characteristics are associated with vision-related quality of life (QOL) after endothelial keratoplasty.

Methods: A patient- and outcome-masked randomized clinical trial. Consecutive patients presenting with isolated endothelial disease requiring endothelial keratoplasty at Oregon Health Sciences University and Stanford University. Read More

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Urinary dipeptidyl peptidase-4 protein is increased by linagliptin and is a potential predictive marker of urine albumin-to-creatinine ratio reduction in patients with type 2 diabetes.

Diabetes Obes Metab 2021 Apr 21. Epub 2021 Apr 21.

Boehringer Ingelheim International GmbH, Ingelheim, Germany.

Results of a post-hoc analysis of urinary dipeptidyl peptidase-4 (DPP-4) protein as a predictor of urinary albumin-to-creatinine ratio (UACR) response to linagliptin treatment based on MARLINA-T2D trial data are described. MARLINA was a 24-week, phase 3b, multinational, placebo-controlled clinical trial in which patients with type 2 diabetes (T2D), glycated haemoglobin 6.5-10. Read More

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Effect of the use of earplugs and eye masks on the quality of sleep after major abdominal surgery: a randomised controlled trial.

Anaesthesia 2021 Apr 21. Epub 2021 Apr 21.

Department of Surgical Intensive Care, Anaesthesia, Singapore General Hospital, Singapore.

Significant sleep disturbance can occur following major abdominal surgery. We aimed to evaluate the effectiveness of earplugs and eye masks in improving sleep quality and patient satisfaction, reducing nursing demands and in the incidence of delirium in patients after major abdominal surgery. We conducted a randomised controlled trial in 100 patients undergoing major abdominal surgery. Read More

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