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Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study.

Eur J Cancer 2021 Sep 15;157:225-237. Epub 2021 Sep 15.

Department of Oncology, Lausanne University Hospital (CHUV), Lausanne, Switzerland; Institute of Higher Education and Research in Healthcare, Faculty of Biology and Medicine, University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland. Electronic address:

Background: Immune-related adverse events (IrAEs) associated with the use of immune checkpoint inhibitors (ICIs) may not be fully covered by existing measures like the PRO-CTCAE™. Selecting PRO-CTCAE™ items for monitoring symptomatic adverse events is hindered by the heterogeneity and complexity of IrAEs, and no standardised selection process exists. We aimed to reach expert consensus on the PRO-CTCAE™ symptom terms relevant for cancer patients receiving ICIs and to gather preliminary expert opinions about additional symptom terms reflecting ICI symptomatic toxicities. Read More

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September 2021

Neuromyelitis optica spectrum disorder (NMOSD) associated with cancer: A systematic review.

Mult Scler Relat Disord 2021 Aug 27;56:103227. Epub 2021 Aug 27.

Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran; Department of Neurology, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address:

NMOSD: is a disease shown to be highly associated with other diseases such as autoimmune diseases. There are a few reports of this association with cancer. So, this systematic review aimed to obtain a broad understanding on the cancers associated in NMOSD, including the source of common perceptions and assumptions in this regard. Read More

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Spatialization of saturated hydraulic conductivity using the Bayesian Maximum Entropy method: Application to wastewater infiltration areas.

Water Res 2021 Aug 28;204:117607. Epub 2021 Aug 28.

INRAE, REVERSAAL, F-69626 Villeurbanne Cedex, France.

Wastewater treatment, a major issue at the European level, focuses on improving surface water and groundwater quality, preserving the receiving environment, and ensuring a sustainable use of water. Soil infiltration is increasingly practiced downstream of wastewater treatment plants, particularly in rural areas without surface water bodies, as is the use of soil as an additional buffer and treatment step. However, the design of infiltration areas on heterogeneous soils remains an extremely complex task due to the costly and time-consuming spatial measurement of saturated hydraulic conductivity (Ks). Read More

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Barriers and facilitators to using vaporised nicotine products as smoking cessation aids among people receiving treatment for substance use disorder.

Addict Behav 2021 Aug 24;124:107097. Epub 2021 Aug 24.

The University of Newcastle, Faculty of Health and Medicine, School of Medicine and Public Health, 1 University Drive, Callaghan, NSW 2308, Australia; Hunter Medical Research Institute, Lot 1 Kookaburra Circuit, New Lambton Heights, NSW 2305, Australia; Flinders University, College of Medicine & Public Health, Level 5 Flinders Medical Centre, Bedford Park, SA 5042, Australia.

Introduction: Vaporised nicotine products (VNPs) may be useful smoking cessation aids for people in alcohol and other drug (AOD) treatment, a population with high tobacco-related morbidity and mortality rates. This qualitative study aimed to examine the barriers and facilitators of using VNPs as part of a clinical trial to reduce or quit smoking among people in AOD treatment.

Methods: Thirteen people in AOD treatment who were participating in a trial of VNPs for smoking cessation (QuitENDs) completed a brief semi-structured interview examining experiences of using VNPs to reduce or quit smoking. Read More

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Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial.

Lancet Neurol 2021 Oct;20(10):821-831

Department of Basic and Clinical Neuroscience, Maurice Wohl Clinical Neuroscience Institute, and Department of Neurology, King's College Hospital, King's College London, London, UK.

Background: There is an urgent unmet need for new therapies in amyotrophic lateral sclerosis. In a clinical study with healthy volunteers, levosimendan, a calcium sensitiser, was shown to improve neuromechanical efficiency and contractile function of the human diaphragm. We aimed to evaluate the safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis, with a focus on respiratory function. Read More

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October 2021

A comprehensive prognostic analysis of osimertinib treatment in advanced non-small cell lung cancer patients with acquired EGFR-T790M mutation: a real-world study.

J Cancer Res Clin Oncol 2021 Sep 18. Epub 2021 Sep 18.

Department of Radiology, West China Hospital, Sichuan University, 37# Guo Xue Xiang, Chengdu, 610041, Sichuan, China.

Purpose: Osimertinib is the standard treatment for advanced non-small cell lung cancer (NSCLC) patients with T790M mutation after the failure of first-/second-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI). We comprehensively analyzed factors that affect the therapeutic efficacy of the osimertinib treatment in NSCLC patients.

Methods: 351 NSCLC patients with T790M mutation receiving osimertinib treatment were included. Read More

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September 2021

Population pharmacokinetic analysis of entrectinib in pediatric and adult patients with advanced/metastatic solid tumors: support of new drug application submission.

Cancer Chemother Pharmacol 2021 Sep 18. Epub 2021 Sep 18.

Roche Pharmaceutical Research and Early Development, Roche Innovation Center, F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, Basel, Switzerland.

Purpose: Entrectinib (ROZLYTREK) is a CNS-active, potent, and selective inhibitor of ROS1, TRK A/B/C, and ALK kinase activity. It was recently approved for the treatment of ROS1-positive non-small cell lung cancer and NTRK gene fusion-positive solid tumors. The main objective of this analysis was to characterize the pharmacokinetics (PK) of entrectinib and its main active metabolite, M5. Read More

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September 2021

Dose-dependent effect of mesenchymal stromal cells co-grafted with dopaminergic neurons in a Parkinson's disease rat model.

J Cell Mol Med 2021 Sep 18. Epub 2021 Sep 18.

Cellular and Molecular Neurobiology of Parkinson's disease, Research Center for Molecular Medicine and Chronic diseases (CIMUS), IDIS, University of Santiago de Compostela, Santiago de Compostela, Spain.

A major limiting factor for cell therapy in Parkinson's disease is the poor survival and reinnervation capacity of grafted dopaminergic neurons, independently of the cell source. Mesenchymal stromal cells (MSCs) have high capability to regulate the local environment through the release of trophic, antiapoptotic and immunomodulatory factors. In this work, we investigated whether co-grafting of MSCs could improve the survival and reinnervation ability of dopaminergic precursors transplanted in animal models of Parkinson's disease. Read More

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September 2021

The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids.

Arthritis Rheumatol 2021 Sep 17. Epub 2021 Sep 17.

Metroplex Clinical Research Center, Dallas.

Objective: To evaluate changes in bone turnover and bone mineral density (BMD) in subjects with rheumatoid arthritis (RA) on glucocorticoid (GC) after discontinuing denosumab for 12 months.

Methods: Randomized, double-blind, placebo-controlled phase 2 study of subjects with RA. Subjects received placebo, or denosumab 60 or 180 mg every 6 months for 12 months and were followed for an additional 12 months after discontinuation, during which no bone loss prevention therapy was instituted. Read More

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September 2021

Combined assessment of the GAP index and body mass index at antifibrotic therapy initiation for prognosis of idiopathic pulmonary fibrosis.

Sci Rep 2021 Sep 17;11(1):18579. Epub 2021 Sep 17.

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka, 431-3192, Japan.

Antifibrotic therapy (AFT) slows disease progression in patients with idiopathic pulmonary fibrosis (IPF). The Gender-Age-Physiology (GAP) index, was developed based on data at IPF diagnosis before the introduction of AFT and has not been evaluated in the AFT context. Further, recent advances have revealed the importance of body-composition factors in prognosis of IPF treated with AFT. Read More

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September 2021

A phase 2, proof of concept, randomised controlled trial of berberine ursodeoxycholate in patients with presumed non-alcoholic steatohepatitis and type 2 diabetes.

Nat Commun 2021 Sep 17;12(1):5503. Epub 2021 Sep 17.

Hightide Therapeutics, Rockville, MD, USA.

Non-alcoholic steatohepatitis is frequently associated with diabetes and may cause progressive liver disease. Current treatment options are limited. Here we report on a prospective, randomised, double-blind, placebo-controlled trial of two doses of HTD1801 (berberine ursodeoxycholate, an ionic salt of berberine and ursodeoxycholic acid), versus placebo that was conducted in 100 subjects with fatty liver disease and diabetes (NCT03656744). Read More

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September 2021

Critical illness in patients with metastatic cancer: a population-based cohort study of epidemiology and outcomes.

Authors:
Lavi Oud

J Investig Med 2021 Sep 17. Epub 2021 Sep 17.

Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Texas Tech University Health Sciences Center at the Permian Basin, Odessa, Texas, USA

The appropriateness of intensive care unit (ICU) admission of patients with metastatic cancer remains debated. We aimed to examine the short-term outcomes and their temporal pattern in critically ill patients with metastatic disease. We used state-wide data to identify hospitalizations aged ≥18 years with metastatic cancer admitted to ICU in Texas during 2010-2014. Read More

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September 2021

Risk prediction of covid-19 related death and hospital admission in adults after covid-19 vaccination: national prospective cohort study.

BMJ 2021 Sep 17;374:n2244. Epub 2021 Sep 17.

Division of Primary Care, School of Medicine, University of Nottingham, Nottingham, UK.

Objectives: To derive and validate risk prediction algorithms to estimate the risk of covid-19 related mortality and hospital admission in UK adults after one or two doses of covid-19 vaccination.

Design: Prospective, population based cohort study using the QResearch database linked to data on covid-19 vaccination, SARS-CoV-2 results, hospital admissions, systemic anticancer treatment, radiotherapy, and the national death and cancer registries.

Settings: Adults aged 19-100 years with one or two doses of covid-19 vaccination between 8 December 2020 and 15 June 2021. Read More

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September 2021

Overall Survival of Patients Receiving Cisplatin or Carboplatin for Primary Metastatic Urothelial Carcinoma of the Bladder: A Contemporary Dutch Nationwide Cohort Study.

Eur Urol Focus 2021 Sep 14. Epub 2021 Sep 14.

Department of Research and Development, The Netherlands Comprehensive Cancer Organisation, Utrecht, The Netherlands; Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.

Background: Cisplatin is preferred to carboplatin when treating metastatic urothelial carcinoma of the bladder (mUCB), despite its greater toxicity. Randomised studies underpinning this have been performed in noncontemporary populations with limitations in sample sizes and analyses, affecting their validity in current clinical practice.

Objective: To estimate overall survival (OS) and assess the benefit of cisplatin-based regimens over carboplatin-based regimens in a contemporary cohort of patients with mUCB. Read More

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September 2021

Image intensity histograms as imaging biomarkers: application to immune-related colitis.

Biomed Phys Eng Express 2021 Sep 17. Epub 2021 Sep 17.

7033 Wisconsin Institute for Medical Research Department of Medical Physics, University of Wisconsin-Madison, 1111 Highland Avenue, Madison, Madison, Wisconsin, 53706, UNITED STATES.

Purpose To investigate image intensity histograms as a potential source of useful imaging biomarkers in both a clinical example of detecting immune-related colitis (irColitis) inF-FDG PET/CT images of immunotherapy patients and an idealized case of classifying digital reference objects (DRO). Methods Retrospective analysis of bowelF-FDG uptake in N=40 patients receiving immune checkpoint inhibitors was conducted. A CNN trained to segment the bowel was used to generate the histogram of bowelF-FDG uptake, and percentiles of the histogram were considered as potential metrics for detecting inflammation associated with irColitis. Read More

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September 2021

Concepts behind epilepsy among Egyptian patients. Is it a disease or a possession?!

Epilepsy Res 2021 Sep 13;177:106760. Epub 2021 Sep 13.

Faculty of Medicine Ain Shams University, Egypt.

Background: Many epileptic patients visit traditional healers secondary to unaffordability, inaccessibility of medical service and being refractory. This may lead to delay in seeking medical advice and may influence prognosis.

Objectives: Studying concepts behind epilepsy among Egyptian epilepsy sufferers including beliefs behind epilepsy and whether there is difference in these beliefs as regards gender, education and urban to rural socioeconomic status. Read More

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September 2021

Heavy episodic drinking and HIV disclosure by HIV treatment status among People with HIV in IeDEA Cameroon.

Int J Drug Policy 2021 Sep 14;98:103431. Epub 2021 Sep 14.

University of North Carolina at Chapel Hill, United States.

Background: Heavy alcohol use is common among people with HIV (PWH), leading to sub-optimal HIV care outcomes. Yet, heavy episodic drinking (HED) is not routinely addressed within most HIV clinics in sub-Saharan Africa. HIV disclosure may provide social support, potentially reducing HED to cope with HIV. Read More

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September 2021

Role of extracellular matrix structural components and tissue mechanics in the development of postoperative pancreatic fistula.

J Biomech 2021 Aug 27;128:110714. Epub 2021 Aug 27.

Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Julius Wolff Institute, Augustenburger Platz 1, Berlin 13353, Germany; Berlin Institute of Health at Charité - Universitätsmedizin Berlin, BIH Center for Regenerative Therapies (BCRT), Charitéplatz 1, 10117 Berlin, GermanyBerlin Institute of Health Center for Regenerative Therapies, Charité - Universitätsmedizin Berlin, Berlin 13353, Germany; Max Planck Institute of Colloids and Interfaces, Department of Biomaterials, Potsdam 14476, Germany.

Radical resection remains the only curative treatment option in pancreatic cancer. Postoperative pancreatic fistulas (POPF) occur in up to 30% of patients leading to prolonged hospital-stay, increased cost of care and morbidity and mortality. Mechanical properties of the pancreas are associated with POPF. Read More

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Membrane-based technologies for per- and poly-fluoroalkyl substances (PFASs) removal from water: Removal mechanisms, applications, challenges and perspectives.

Environ Int 2021 Sep 14;157:106876. Epub 2021 Sep 14.

ETH Zurich, Department of Health Sciences and Technology, 8092 Zurich, Switzerland; ETH Zurich, Department of Materials, Wolfgang-Pauli-Strasse 10, 8093 Zurich, Switzerland. Electronic address:

Water purification from per- and poly-fluoroalkyl substances (PFASs), as a group of persistent and mobile fluoro-organic contaminants, is receiving increasing attention worldwide due to the ubiquitous presence of these highly toxic compounds. To reduce the risk of exposure of human life to PFASs and their dispersion in the environment, various techniques, primarily based on membrane technologies, have been rapidly developed. Here we critically review and analyze the current state-of-the-art of membrane-based techniques for PFASs removal, including direct membrane filtrations, adsorption-based membranes, and hybrid membrane processes. Read More

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September 2021

Reversing pathology in a preclinical model of Alzheimer's disease by hacking cerebrovascular neoangiogenesis with advanced cancer therapeutics.

EBioMedicine 2021 Sep 14;71:103503. Epub 2021 Sep 14.

Department of Medical Genetics, University of British Columbia, 2350 Health Sciences Mall, Vancouver, BC V6T 1Z4, Canada; Michael Smith Laboratories, University of British Columbia, 2185 East Mall, Vancouver, BC V6T 1Z4, Canada; Centre for Blood Research, University of British Columbia, 2350 Health Sciences Mall, Vancouver, BC V6T 1Z4, Canada; The Djavad Mowafaghian Centre for Brain Health, University of British Columbia, 2215 Wesbrook Mall, Vancouver, BC V6T 1Z4, Canada; Department of Microbiology and Immunology, University of British Columbia, 2350 Health Sciences Mall, Vancouver, BC V6T 1Z4, Canada; Department of Zoology, University of British Columbia, 6270 University Blvd., Vancouver, BC V6T 1Z4, Canada; The Vancouver Prostate Centre, Vancouver General Hospital, 2660 Oak Street, Vancouver, BC V6T 1Z4, Canada; Department of Urologic Sciences, University of British Columbia, Gordon & Leslie Diamond Health Care Centre, Level 6, 2775 Laurel Street, Vancouver, BC V5Z 1M9, Canada. Electronic address:

Background: Cognitive decline leading to dementia, accompanied by the accumulation of amyloid-beta (Aβ) in neuritic plaques together with the appearance of neurofibrillary tangles (NFT) composed of hyperphosphorylated tau protein (tau), are previously noted hallmarks of Alzheimer's disease (AD). We previously discovered hypervascularity in brain specimens from AD patients and consistent with this observation, we demonstrated that overexpression of Aβ drives cerebrovascular neoangiogenesis leading to hypervascularity and coincident tight-junction disruption and blood-brain barrier (BBB) leakiness in animal models of AD. We subsequently demonstrated that amyloid plaque burden and cerebrovascular pathogenesis subside when pro-angiogenic Aβ levels are reduced. Read More

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September 2021

Hypophosphatemia after intravenous iron therapy: Comprehensive review of clinical findings and recommendations for management.

Bone 2021 Sep 14:116202. Epub 2021 Sep 14.

Medical University of Innsbruck, Department of Medicine I, Gastroenterology, Hepatology and Endocrinology, Innsbruck, Austria; Christian Doppler Laboratory on Iron and Phosphate Biology. Electronic address:

Contemporary intravenous iron formulations allow administration of high doses of elemental iron and enable correction of total iron deficit in one or two infusions. An important but underappreciated complication of certain formulations is hypophosphatemia caused by increased secretion of the phosphaturic hormone, fibroblast growth factor 23 (FGF23). The pathophysiology of FGF23-induced hypophosphatemia due to certain intravenous iron formulations has been recently investigated in prospective clinical trials. Read More

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September 2021

Morin attenuates memory deficits in a rat model of Alzheimer's disease by ameliorating oxidative stress and neuroinflammation.

Eur J Pharmacol 2021 Sep 14;910:174506. Epub 2021 Sep 14.

Department of Biology, Zanjan Branch, Islamic Azad University, Zanjan, Iran.

This study aimed to investigate the effect of flavonoid morin on oxidative/nitrosative stress, neuroinflammation, and histological, molecular, and behavioral changes caused by amyloid-beta (Aβ) in male Wistar rats (Alzheimer's disease model). Rats received morin (20 mg/kg, oral gavage) for 14 consecutive days after intrahippocampal injection of Aβ. Morin decreased the levels of malondialdehyde and nitric oxide, increased glutathione content, and enhanced catalase activity in the hippocampus of animals receiving Aβ. Read More

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September 2021

Spanish and Portuguese Parental Acceptance of Behavior Management Techniques in Pediatric Dentistry.

J Clin Pediatr Dent 2021 Oct;45(4):247-252

Aim: To compare acceptance of behavior management techniques used in pediatric dentistry by Spanish and Portuguese parents.

Study Design: cross-sectional study. A survey of 8 behavior management techniques used in pediatric dentistry was administered to parents whose children were being treated at the Universitat Internacional de Cataluña (Barcelona, Spain) or at the Universidade de Coimbra (Portugal). Read More

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October 2021

Ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in healthy elderly subjects.

Eur Heart J 2021 Sep 17. Epub 2021 Sep 17.

AMAG Pharmaceuticals, Inc., 1100 Winter St., Waltham, MA 02450, USA.

Aims : Ciraparantag is a reversal agent for anticoagulants including direct oral anticoagulants. The aim was to evaluate the efficacy and safety of ciraparantag to reverse anticoagulation induced by apixaban or rivaroxaban in healthy elderly adults.

Methods And Results : Two randomized, placebo-controlled, dose-ranging trials conducted in healthy subjects aged 50-75 years. Read More

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September 2021

Estimating the cost and value of functional changes in communication ability following telepractice treatment for aphasia.

PLoS One 2021 17;16(9):e0257462. Epub 2021 Sep 17.

Department of Speech, Language and Hearing Sciences, University of Florida, Gainesville, Florida, United States of America.

Context: Aphasia is a post-stroke condition that can dramatically impact a person with aphasia's (PWA) communication abilities. To date, few if any studies have considered the cost and cost-effectiveness of functional change in aphasia nor considered measures of patient's value for aphasia treatment.

Objective: To assess the cost, cost-effectiveness, and perceived value associated with improved functional communication in individuals receiving telerehabilitation treatment for aphasia. Read More

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September 2021

Community-facility linkage models and maternal and infant health outcomes in Malawi's PMTCT/ART program: A cohort study.

PLoS Med 2021 Sep 17;18(9):e1003780. Epub 2021 Sep 17.

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.

Background: In sub-Saharan Africa, 3 community-facility linkage (CFL) models-Expert Clients, Community Health Workers (CHWs), and Mentor Mothers-have been widely implemented to support pregnant and breastfeeding women (PBFW) living with HIV and their infants to access and sustain care for prevention of mother-to-child transmission of HIV (PMTCT), yet their comparative impact under real-world conditions is poorly understood.

Methods And Findings: We sought to estimate the effects of CFL models on a primary outcome of maternal loss to follow-up (LTFU), and secondary outcomes of maternal longitudinal viral suppression and infant "poor outcome" (encompassing documented HIV-positive test result, LTFU, or death), in Malawi's PMTCT/ART program. We sampled 30 of 42 high-volume health facilities ("sites") in 5 Malawi districts for study inclusion. Read More

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September 2021

Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.

Female Pelvic Med Reconstr Surg 2021 Sep 15. Epub 2021 Sep 15.

From the Department of Urology Department of Obstetrics and Gynecology Department of Healthcare Policy and Research, Weill Cornell Medical College-New York Presbyterian, New York, NY.

Objectives: In recent years, new intravaginal support devices for stress urinary incontinence have been introduced to the market. Although studies have demonstrated their safety and efficacy, few studies have examined adverse events attributed to their use. The objective of this study was to characterize reported adverse events for an over-the-counter intravaginal support device and determine whether further medical treatment was necessary to manage the adverse event. Read More

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September 2021

Panitumumab Plus Fluorouracil and Folinic Acid Versus Fluorouracil and Folinic Acid Alone as Maintenance Therapy in Wild-Type Metastatic Colorectal Cancer: The Randomized PANAMA Trial (AIO KRK 0212).

J Clin Oncol 2021 Sep 17:JCO2101332. Epub 2021 Sep 17.

Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven, Wilhelmshaven, Germany.

Purpose: The randomized PANAMA trial investigated the efficacy of panitumumab (Pmab) when added to maintenance therapy with fluorouracil and folinic acid (FU/FA) in patients with wild-type metastatic colorectal cancer.

Methods: Following first-line induction therapy with six cycles of FU/FA and oxaliplatin plus Pmab, responding patients (stable disease or partial or complete remission) were randomly assigned (1:1, open-label) to maintenance treatment with either FU/FA plus Pmab or FU/FA alone. The primary objective was to demonstrate superiority of progression-free survival (PFS, time from random assignment until progression or death) in favor of FU/FA plus Pmab with a hazard ratio (HR) of 0. Read More

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September 2021

Examining the relationship between pain interference, pain intensity, and mental health symptoms among veterans receiv-ing long-term opioid therapy for chronic noncancer pain in primary care.

J Opioid Manag 2021 Jul-Aug;17(4):289-299

VA Salt Lake City Health Care System, Salt Lake City, Utah.

Objective: As part of the evaluation of the Whole Health Primary Care Pain Education and Opioid Monitoring Program (PC-POP), we examined the relationship between pain intensity, pain interference, and mental health symptoms among PC-POP enrollees.

Design/methods: Retrospective cohort study examining self-reported symptoms of pain intensity, pain interference, anxiety, depression, substance use, and quality of life. Data were retrieved through a combination of chart review and data extracted from the VA Informatics and Computing Infrastructure. Read More

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September 2021