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https://www.readbyqxmd.com/read/29035675/practical-considerations-in-clinical-strategy-to-support-the-development-of-injectable-drug-device-combination-products-for-biologics
#1
Zhaoyang Li, Rachael Easton
The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely...
October 16, 2017: MAbs
https://www.readbyqxmd.com/read/29035611/are-people-who-inject-drugs-frequent-users-of-emergency-department-services-a-cohort-study-2008-2013
#2
Dhanya Nambiar, Tim Spelman, Mark Stoové, Paul Dietze
BACKGROUND: Although people who inject drugs (PWID) have been described as frequent users of emergency services, the majority of research is cross-sectional and involves records from a single emergency department (ED). OBJECTIVES: We describe characteristics of state-wide ED presentations in a cohort of PWID, and compare presentation rates to the general population. We also examine characteristics associated with frequent ED use. METHODS: We used data from a retrospective linkage of public ED presentations from a cohort of 678 PWID between January 2008 and June 2013...
October 16, 2017: Substance Use & Misuse
https://www.readbyqxmd.com/read/29032478/total-knee-arthroplasty-in-patients-with-a-history-of-illicit-intravenous-drug-abuse
#3
David E Bauer, Andreas Hingsammer, Lukas Ernstbrunner, Alexander Aichmair, Andrea B Rosskopf, Franziska Eckers, Karl Wieser, Sandro F Fucentese
PURPOSE: Injection drug users are at high risk for both infection with blood-borne pathogens, namely, human immune deficiency virus (HIV), hepatitis-B, -C virus, various bacterial infections, as well as early primary and secondary joint degeneration. When total knee arthroplasty (TKA) is anticipated the risk of septic complications is a major concern. The purpose of this study was to assess the clinical and radiographic outcome of patients with a history of intravenous drug use after total knee arthroplasty...
October 14, 2017: International Orthopaedics
https://www.readbyqxmd.com/read/29026870/comparing-injecting-drug-users-with-others-receiving-outpatient-parenteral-antibiotic-therapy
#4
Pauline M Dobson, Mark R Loewenthal, Kellie Schneider, Katy Lai
No abstract text is available yet for this article.
2017: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/29024922/isolation-and-whole-genome-analysis-of-endospore-forming-bacteria-from-heroin
#5
Jörn Kalinowski, Björn Ahrens, Arwa Al-Dilaimi, Anika Winkler, Daniel Wibberg, Uwe Schleenbecker, Christian Rückert, Roman Wölfel, Gregor Grass
Infections caused by endospore-forming bacteria have been associated with severe illness and death among persons who inject drugs. Analysis of the bacteria residing in heroin has thus been biased towards species that affect human health. Similarly, exploration of the bacterial diversity of seized street market heroin correlated with the skin microflora of recreational heroin users insofar as different Staphylococus spp. or typical environmental endospore formers including Bacillus cereus and other Bacilli outside the B...
October 4, 2017: Forensic Science International. Genetics
https://www.readbyqxmd.com/read/29021113/association-between-alcohol-consumption-and-injection-and-sexual-risk-behaviors-among-people-who-inject-drugs-in-rural-puerto-rico
#6
Melissa Welch-Lazoritz, Dane Hautala, Patrick Habecker, Kirk Dombrowski
Although alcohol use has been associated with risky behavior generally, the relationship between alcohol use and multiple types of risk behaviors that could lead to the acquisition and transmission of HIV and hepatitis C (HCV) among people who inject drugs (PWID) has not been fully examined. The current study seeks to contribute to the understanding of how alcohol use is related to both injection risk and sexual risk, among a non-treatment, cross-sectional sample of mostly male PWID in rural Puerto Rico (n=315)...
November 2017: Journal of Substance Abuse Treatment
https://www.readbyqxmd.com/read/29016896/poor-working-conditions-and-work-stress-among-canadian-sex-workers
#7
P Duff, J Sou, J Chapman, S Dobrer, M Braschel, S Goldenberg, K Shannon
Background: While sex work is often considered the world's oldest profession, there remains a dearth of research on work stress among sex workers (SWs) in occupational health epidemiological literature. A better understanding of the drivers of work stress among SWs is needed to inform sex work policy, workplace models and standards. Aims: To examine the factors that influence work stress among SWs in Metro Vancouver. Methods: Analyses drew from a longitudinal cohort of SWs, known as An Evaluation of Sex Workers' Health Access (AESHA) (2010-14)...
August 23, 2017: Occupational Medicine
https://www.readbyqxmd.com/read/29016621/epidemic-dispersion-of-hiv-and-hcv-in-a-population-of-co-infected-romanian-injecting-drug-users
#8
Simona Paraschiv, Leontina Banica, Ionelia Nicolae, Iulia Niculescu, Adrian Abagiu, Raluca Jipa, Andrea-Clemencia Pineda-Peña, Marta Pingarilho, Emil Neaga, Kristof Theys, Pieter Libin, Dan Otelea, Ana Abecasis
Co-infections with HIV and HCV are very frequent among people who inject drugs (PWID). However, very few studies comparatively reconstructed the transmission patterns of both viruses in the same population. We have recruited 117 co-infected PWID during a recent HIV outbreak in Romania. Phylogenetic analyses were performed on HIV and HCV sequences in order to characterize and compare transmission dynamics of the two viruses. Three large HIV clusters (2 subtype F1 and one CRF14_BG) and thirteen smaller HCV transmission networks (genotypes 1a, 1b, 3a, 4a and 4d) were identified...
2017: PloS One
https://www.readbyqxmd.com/read/28989321/-because-i-ve-been-extremely-careful-hiv-seroconversion-responsibility-citizenship-and-the-neo-liberal-drug-using-subject
#9
Andrea Krüsi, Ryan McNeil, David Moore, Will Small
In this article we examine how injection drug users who do not attribute their HIV infection to engaging in HIV risk behaviours take up and critique discourses of individual responsibility and citizenship relating to HIV risk and HIV prevention. We draw on data from a study in Vancouver, Canada (2006 - 2009) in which we interviewed individuals living with HIV who had a history of injection drug use. In this paper we focus on 6 cases studies of participants who did not attribute their HIV infection to engaging in HIV risk behaviours...
2017: Health, Risk & Society
https://www.readbyqxmd.com/read/28987019/patterns-of-substance-use-and-mortality-risk-in-a-cohort-of-hard-to-reach-polysubstance-users
#10
Linn Gjersing, Anne Line Bretteville-Jensen
AIMS: To examine the mortality risk in a cohort of "hard-to-reach" polysubstance users and its putative associations with substance use. Specifically, we estimated all-cause mortality risk as a function of individual substance use indicators, and then as a function of their complex, "real-life" patterns as identified through Latent Class Analysis (LCA). DESIGN: Prospective cohort study among street-and low-threshold-service-recruited polysubstance users included between September and November 2013 and followed through the National Cause of Death Registry until 31 October 2015...
October 7, 2017: Addiction
https://www.readbyqxmd.com/read/28981193/organ-utilization-from-increased-infectious-risk-donors-an-observational-study
#11
Arnaud G L'Huillier, Atul Humar, Clare Payne, Deepali Kumar
BACKGROUND: Donors with an increased risk of transmitting human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) (increased risk donors [IRDs]) are a potential source of organs for transplant. Organs from IRDs can be utilized with appropriate recipient consent and post-transplant follow-up. We reviewed the characteristics and utilization of IRDs in our Organ Procurement Organization (OPO) over a 2-year period. METHODS: Donor information from April 1, 2013 to March 31, 2015 was obtained through the OPO database...
October 5, 2017: Transplant Infectious Disease: An Official Journal of the Transplantation Society
https://www.readbyqxmd.com/read/28975029/cascade-of-care-among-hiv-patients-diagnosed-in-2013-in-georgia-risk-factors-for-late-diagnosis-and-attrition-from-hiv-care
#12
Ekaterine Ruadze, Nikoloz Chkhartishvili, Otar Chokoshvili, Tengiz Tsertsvadze
INTRODUCTION: The major challenge in the HIV epidemic in Georgia is a high proportion of undiagnosed people living with HIV (estimated 48%) as well as a very high proportion of late presentations for care, with 66% presenting for HIV care with CD4 count <350 and 40% with <200 cells/mm(3), in 2013. The objectives of this study was to evaluate patient engagement in the continuum of HIV care for HIV patients diagnosed in 2013 and, within this cohort, to evaluate factors associated with late diagnosis and attrition from care...
2017: SAGE Open Medicine
https://www.readbyqxmd.com/read/28974239/history-of-medication-assisted-treatment-and-its-association-with-initiating-others-into-injection-drug-use-in-san-diego-ca
#13
Maria Luisa Mittal, Devesh Vashishtha, Shelly Sun, Sonia Jain, Jazmine Cuevas-Mota, Richard Garfein, Steffanie A Strathdee, Dan Werb
BACKGROUND: Medication-assisted treatment (MAT) remains the gold standard for the treatment of opioid use disorder. MAT also reduces the frequency of injecting among people who inject drugs (PWID). Relatedly, data suggest that PWID play a key role in the initiation of others into drug injecting by exposing injecting practices to injection-naïve drug users. Our primary objective was to test whether a history of MAT enrollment is associated with a reduced odds of PWID providing injection initiation assistance...
October 3, 2017: Substance Abuse Treatment, Prevention, and Policy
https://www.readbyqxmd.com/read/28969490/reducing-substance-use-and-risky-sexual-behaviour-among-drug-users-in-durban-south-africa-assessing-the-impact-of-community-level-risk-reduction-interventions
#14
C D H Parry, T Carney, P Petersen Williams
Alcohol and other drug (AOD) use is increasingly recognised as having a direct and indirect effect on the transmission of human immunodeficiency virus (HIV). However, there is evidence to suggest that drug- and sex-related HIV risk-reduction interventions targeted at drug users within drug treatment centres or via community outreach efforts can lead to positive health outcomes. This study aimed to test whether a community-level intervention aimed at AOD users has an impact on risky AOD use and sexual risk behaviour...
December 2017: SAHARA J: Journal of Social Aspects of HIV/AIDS Research Alliance
https://www.readbyqxmd.com/read/28967582/new-hiv-diagnoses-among-adults-aged-50-years-or-older-in-31-european-countries-2004-15-an-analysis-of-surveillance-data
#15
Lara Tavoschi, Joana Gomes Dias, Anastasia Pharris
BACKGROUND: The HIV burden is increasing in older adults in the European Union (EU) and European Economic Area (EEA). We investigated factors associated with HIV diagnosis in older adults in the 31 EU/EEA countries during a 12 year period. METHODS: In this analysis of surveillance data, we compared data from older people (aged ≥50 years) with those from younger people (aged 15-49 years). We extracted new HIV diagnoses reported to the European Surveillance System between Jan 1, 2004, and Dec 31, 2015, and stratified them by age, sex, migration status, transmission route, and CD4 cell count...
September 26, 2017: Lancet HIV
https://www.readbyqxmd.com/read/28962612/spatial-distribution-of-hiv-hcv-and-co-infections-among-drug-users-in-the-southwestern-border-areas-of-china-2004-2014-a-cohort-study-of-a-national-methadone-maintenance-treatment-program
#16
Mingli Li, Rongjian Li, Zhiyong Shen, Chunying Li, Nengxiu Liang, Zhenren Peng, Wenbo Huang, Chongwei He, Feng Zhong, Xianyan Tang, Guanghua Lan
BACKGROUND: A methadone maintenance treatment (MMT) program to curb the dual epidemics of HIV/AIDS and drug use has been administered by China since 2004. Little is known regarding the geographic heterogeneity of HIV and hepatitis C virus (HCV) infections among MMT clients in the resource-constrained context of Chinese provinces, such as Guangxi. This study aimed to characterize the geographic distribution patterns and co-clustered epidemic factors of HIV, HCV and co-infections at the county level among drug users receiving MMT in Guangxi Zhuang Autonomous Region, located in the southwestern border area of China...
September 30, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28960166/perceived-treatment-need-and-latent-transitions-in-heroin-and-methamphetamine-polydrug-use-among-people-who-inject-drugs-in-tijuana-mexico
#17
Meredith C Meacham, Scott C Roesch, Steffanie A Strathdee, Tommi L Gaines
People who inject drugs (PWID) in Tijuana, Mexico, use heroin and/or methamphetamine. While polydrug use is associated with HIV risk behavior, less is known about the stability of polydrug use patterns over time and how polydrug use is related to perceived treatment need. Within a cohort of PWID in Tijuana (N = 735) we sought to (1) characterize subgroups of polydrug and polyroute use from baseline to six months; (2) determine the probabilities of transitioning between subgroups; and (3) examine whether self-reported need for help for drug use modified these transition probabilities...
September 29, 2017: Journal of Psychoactive Drugs
https://www.readbyqxmd.com/read/28946634/towards-robot-assisted-retinal-vein-cannulation-a-motorized-force-sensing-microneedle-integrated-with-a-handheld-micromanipulator-%C3%A2
#18
Berk Gonenc, Jeremy Chae, Peter Gehlbach, Russell H Taylor, Iulian Iordachita
Retinal vein cannulation is a technically demanding surgical procedure where therapeutic agents are injected into the retinal veins to treat occlusions. The clinical feasibility of this approach has been largely limited by the technical challenges associated with performing the procedure. Among the challenges to successful vein cannulation are identifying the moment of venous puncture, achieving cannulation of the micro-vessel, and maintaining cannulation throughout drug delivery. Recent advances in medical robotics and sensing of tool-tissue interaction forces have the potential to address each of these challenges as well as to prevent tissue trauma, minimize complications, diminish surgeon effort, and ultimately promote successful retinal vein cannulation...
September 23, 2017: Sensors
https://www.readbyqxmd.com/read/28943522/community-based-molecular-epidemiology-study-of-hepatitis-c-virus-infection-in-injection-drug-users
#19
D Pc Chan, K Ck Lee, S S Lee, T Y Tan
No abstract text is available yet for this article.
August 2017: Hong Kong Medical Journal, Xianggang Yi Xue za Zhi
https://www.readbyqxmd.com/read/28932350/lurking-epidemic-of-hepatitis-c-virus-infection-in-iran-a-call-to-action
#20
Reza Taherkhani, Fatemeh Farshadpour
Despite having a relatively low prevalence in the Iranian general population, the burden of hepatitis C virus (HCV) infection is on the rise, and hepatitis C is predicted to be the most important leading cause of viral hepatitis-related mortality in the near future in Iran. The recent population-based epidemiological studies have revealed the predominant role of injecting drug use in increasing prevalence of HCV infection. Undoubtedly, new management paradigm is required to drive down the rising wave of hepatitis C in Iran...
August 28, 2017: World Journal of Hepatology
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