bluuebunny/crossref_metadata_2025_split huggingface dataset:
Community perspective on the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Authors: Geffen N , Aagaard P , Corbelli GM , Meulbroek M , Peavy D , Rappoport C , Schwarze S , Collins S ,   International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Community Advisory Board
Published: February 2015

Determining when to start antiretroviral treatment (ART) is vitally important for people living with HIV. Yet the optimal point at which to start to maximize clinical benefit remains unknown. In the absence of randomized studies, current guidelines rely on conflicting observational data and expert opinion, and consequently diverge on this point. In the USA, ART is recommended irrespective of CD4 cell count. The World Health Organization now recommends starting ART at a CD4 cell count of 500 cells/μL, while the threshold for the UK and South Africa remains at 350 cells/μL.The Strategic Timing of AntiRetroviral Treatment (START) study, one of the largest clinical trials on the treatment of HIV infection, will answer this question. START compares two treatment strategies: immediate treatment at a CD4 cell count of 500 cells/μL or higher versus deferring treatment until the CD4 cell count decreases to 350 cells/μL or until AIDS develops. START includes seven substudies, five of which will clarify the relative contributions of HIV and ART in common comorbidities. START is fully enrolled and expected to be completed in 2016. HIV advocates support the study's design and have been involved from inception to enrolment. The trial will produce rigorous data on the benefits and risks of earlier treatment. It will inform policy and treatment advocacy globally, benefitting the health of HIV‐positive people.
Demographic and HIV‐specific characteristics of participants enrolled in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Authors: Sharma S , Babiker AG , Emery S , Gordin FM , Lundgren JD , Neaton JN , Bakowska E , Schechter M , Wiselka MJ , Wolff MJ ,   International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group
Published: February 2015

ObjectivesThe risks and benefits of initiating antiretroviral treatment (ART) at high CD4 cell counts have not been reliably quantified. The Strategic Timing of AntiRetroviral Treatment (START) study is a randomized international clinical trial that compares immediate with deferred initiation of ART for HIV‐positive individuals with CD4 cell counts above 500 cells/μL. We describe the demographics, HIV‐specific characteristics and medical history of this cohort.MethodsData collected at baseline include demographics, HIV‐specific laboratory values, prior medical diagnoses and concomitant medications. Baseline characteristics were compared by geographical region, gender and age.ResultsSTART enrolled 4685 HIV‐positive participants from 215 sites in 35 countries. The median age is 36 years [interquartile range (IQR) 29–44 years], 27% are female, and 45% self‐identify as white, 30% as black, 14% as Latino/Hispanic, 8% as Asian and 3% as other. The route of HIV acquisition is reported as men who have sex with men in 55% of participants, heterosexual sex in 38%, injecting drug use in 1% and other/unknown in 5%. Median time since HIV diagnosis is 1.0 year (IQR 0.4–3.0 years) and the median CD4 cell count and HIV RNA values at study entry are 651 cells/μL (IQR 584–765 cells/μL) and 12 754 HIV RNA copies/mL (IQR 3014–43 607 copies/mL), respectively.ConclusionsSTART has enrolled a diverse group of ART‐naïve individuals with high CD4 cell counts who are comparable to the HIV‐positive population from the regions in which they were enrolled. The information collected with this robust study design will provide a database with which to evaluate the risks and benefits of early ART use for many important outcomes.
Baseline cardiovascular risk in the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Authors: Soliman EZ , Sharma S , Arastéh K , Wohl D , Achhra A , Tambussi G , O'Connor J , Stein JH , Duprez DA , Neaton JD , Phillips A ,   International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group
Published: February 2015

ObjectivesThe Strategic Timing of AntiRetroviral Treatment (START) trial has recruited antiretroviral‐naïve individuals with high CD4 cell counts from all regions of the world. We describe the distribution of cardiovascular disease (CVD) risk factors, overall and by geographical region, at study baseline.MethodsThe distribution of CVD risk factors was assessed and compared by geographical region among START participants who had a baseline electrocardiogram (n = 4019; North America, 11%; Europe/Australia/Israel, 36%; South America, 26%; Asia, 4%; Africa, 23%; median age 36 years; 26% female).ResultsAbout 58.3% (n = 2344) of the participants had at least one CVD risk factor and 18.9% (n = 761) had two or more. The most common CVD risk factors were current smoking (32%), hypertension (19.3%) and obesity (16.5%). There were significant differences in the prevalence of CVD risk factors among geographical regions. The prevalence of at least one risk factor across regions was as follows: North America, 70.0%; Europe/Australia/Israel, 65.1%; South America, 49.4%; Asia, 37.0%; Africa, 55.8% (P‐value < 0.001). Significant regional differences were also observed when risk factors were used as part of the Framingham and Data Collection on Adverse events of Anti‐HIV Drugs (D:A:D) risk scores or used to define a favourable risk profile.ConclusionsCVD risk factors are common among START participants, and their distribution varies by geographical region. Better understanding of how and why CVD risk factors develop in people with HIV infection and their geographical distributions could shed light on appropriate strategies for CVD prevention and may inform the interpretation of the results of START, as CVD is expected to be a major fraction of the primary endpoints observed.
Quality of life assessment among HIV‐positive persons entering the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Authors: Lifson AR , Grandits GA , Gardner EM , Wolff MJ , Pulik P , Williams I , Burman WJ ,   International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group
Published: February 2015

ObjectivesWith HIV treatment prolonging survival and HIV infection now managed as a chronic illness, quality of life (QOL) is important to evaluate in persons living with HIV (PLWH). We assessed at study entry the QOL of antiretroviral‐naïve PLWH with CD4 counts > 500 cells/μL in the Strategic Timing of AntiRetroviral Treatment (START) clinical trial.MethodsQOL was assessed with: (1) a visual analogue scale (VAS) for self‐assessment of overall current health; (2) the Short‐Form 12‐Item Version 2 Health Survey® (SF‐12V2), for which responses are summarized into eight individual QOL domains plus component summary scores for physical health [the Physical Health Component Summary (PCS)] and mental health [the Mental Health Component Summary (MCS)]. The VAS and eight domain scores were scaled from 0 to 100. Mean QOL measures were calculated overall and by demographic, clinical and behavioural factors.ResultsA total of 4631 participants completed the VAS and 4119 the SF‐12. The mean VAS score (with standard deviation) was 80.9 ± 15.7. Mean SF‐12 domain scores were lowest for vitality (66.3 ± 26.4) and mental health (68.6 ± 21.4), and highest for physical functioning (89.3 ± 23.0) and bodily pain (88.0 ± 21.4). Using multiple linear regression, PCS scores were lower (P < 0.001) for Asians, North Americans, female participants, older participants, and those with less education, longer duration of known HIV infection, alcoholism/substance dependence and body mass index ≥ 30 kg/m2. MCS scores were highest (P < 0.001) for Africans, South Americans and older participants, and lowest for female participants, current smokers and those with alcoholism/substance dependence.ConclusionsIn this primarily healthy population, QOL was mostly favourable, emphasizing that it is important that HIV treatments do not negatively impact QOL. Self‐assessed physical health summary scores were higher than mental health scores. Factors such as older age and geographical region had different effects on perceived physical and mental health.
Pulmonary function in an international sample of HIV‐positive, treatment‐naïve adults with CD4 counts > 500 cells/μL: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Authors: Kunisaki KM , Niewoehner DE , Collins G , Nixon DE , Tedaldi E , Akolo C , Kityo C , Klinker H , La Rosa A , Connett JE ,   International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group
Published: February 2015

ObjectivesThe aim of the study was to describe the prevalence and correlates of chronic obstructive pulmonary disease (COPD) in a multicentre international cohort of persons living with HIV (PLWH).MethodsWe performed a cross‐sectional analysis of adult PLWH, naïve to HIV treatment, with baseline CD4 cell count > 500 cells/μL enrolled in the Pulmonary Substudy of the Strategic Timing of AntiRetroviral Treatment (START) trial. We collected standardized, quality‐controlled spirometry. COPD was defined as forced expiratory volume in 1 s:forced vital capacity (FEV1:FVC) ratio less than the lower limit of normal.ResultsAmong 1026 participants from 80 sites and 20 countries, the median age was 36 [interquartile range (IQR) 30, 44] years, 29% were female, and the median time since HIV diagnosis was 1.2 (IQR 0.4, 3.5) years. Baseline median CD4 cell count was 648 (IQR 583, 767) cells/μL, median viral load was 4.2 (IQR 3.5, 4.7) log10 HIV‐1 RNA copies/mL, and 10% had a viral load ≤ 400 copies/mL despite lack of HIV treatment. Current/former/never smokers comprised 28%/11%/61% of the cohort, respectively. COPD was present in 6.8% of participants, and varied by age, smoking status and region. Forty‐eight per cent of those with COPD reported lifelong nonsmoking. In multivariable regression, age and pack‐years of smoking had the strongest associations with FEV1:FVC ratio (P < 0.0001). There was a significant effect of region on FEV1:FVC ratio (P = 0.010).ConclusionsOur data suggest that, among PLWH who were naïve to HIV treatment and had CD4 cell counts > 500 cells/μL, smoking and age were important factors related to COPD. Smoking cessation should remain a high global priority for clinical care and research in PLWH.
Prevalence of and risk factors for low bone mineral density in untreated HIV infection: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial
Authors: Carr A , Grund B , Neuhaus J , Schwartz A , Bernardino JI , White D , Badel‐Faesen S , Avihingsanon A , Ensrud K , Hoy J ,   International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) START Study Group
Published: February 2015

ObjectivesHIV infection is associated with a higher prevalence of low bone mineral density (BMD) and fractures than that found in the general population. There are limited data in HIV‐positive adults, naïve to antiretroviral therapy (ART), with which to estimate the relative contribution of untreated HIV infection to bone loss.MethodsThe primary objective of the Strategic Timing of AntiRetroviral Treatment (START) Bone Mineral Density Substudy is to compare the effect of immediate versus deferred initial ART on bone. We evaluated traditional, demographic, HIV‐related and immunological factors for their associations with baseline hip and lumbar spine BMD, measured by dual‐energy X‐ray absorptiometry, using multiple regression.ResultsA total of 424 ART‐naïve participants were enrolled at 33 sites on six continents; the mean age was 34 years [standard deviation (SD) 10.1 years], 79.0% were nonwhite, 26.0% were women, and 12.5% had a body mass index (BMI) < 20 kg/m2. Mean (SD) Z‐scores were −0.41 (0.94) at the spine and −0.36 (0.88) for total hip; 1.9% had osteoporosis and 35.1% had low BMD (hip or spine T‐score < −1.0). Factors independently associated with lower BMD at the hip and spine were female sex, Latino/Hispanic ethnicity, lower BMI and higher estimated glomerular filtration rate. Longer time since HIV diagnosis was associated with lower hip BMD. Current or nadir CD4 cell count and HIV viral load were not associated with BMD.ConclusionsIn this geographically and racially diverse population of ART‐naïve adults with normal CD4 cell counts, low BMD was common, but osteoporosis was rare. Lower BMD was significantly associated with traditional risk factors but not with CD4 cell count or viral load.
β‐cyclodextrin in personal care formulations: role on the complexation of malodours causing molecules
Authors: Lopedota A. , Cutrignelli A. , Laquintana V. , Franco M. , Donelli D. , Ragni L. , Tongiani S. , Denora N. 
Published: February 2015

SynopsisObjectiveThe aim of this study was to prove the capability of β‐cyclodextrin (β‐CD) to interact with some representative molecules responsible to cause body malodour, such as carboxylic acids, thiols and steroids, present in sweat and body secretions.MethodsThe association constants in guest‐CD were determined by 1H‐NMR spectroscopy for thiols and steroids such as 3‐mercapto‐1‐hexanol, androstenone, androstenol and androsterone, and pH‐potentiometric titration for acetic acid, l(+) lactic acid, isobutyric acid, isovaleric acid and 3‐hydroxy‐3‐methyl‐hexanoic acid.ResultsAll considered systems are able to interact with relatively weak association constants with β‐cyclodextrin, in a 1 : 1 host–guest ratio.ConclusionFrom these findings, it is possible to conclude that β‐CD is capable to interact with different components present in the sweat and body secretion, forming inclusion complexes. For this reason, β‐CD could be a component of body care formulations, such as deodorants.
Proposal of a classification system for opportunities to innovate in skin care products
Authors: Souza I. D. da S. , Almeida T. L. , Takahashi V. P. 
Published: February 2015

SynopsisObjectivesWhat are the opportunities to innovate in a skin care product? There are certainly many opportunities and many technologies involved. In this work, we assumed the role of identifying and categorizing these opportunities to develop a comprehensive and intelligible classification system, which could be used as a tool to support decision‐making in different professional contexts.MethodsInitially, we employed the Delphi method to identify, discuss and standardize the opportunities to innovate in a skin care product. Finally, we used the classification system obtained in the previous phase to label patent applications, therefore, testing the suitability and utility of the system.ResultsAt the end of the process, we achieved a 10‐category classification system for opportunities to innovate in skin care products, and we also illustrated how this system could be used.ConclusionThe resultant classification system offers a normalized terminology for cosmetic scientists interested in dealing with the particularities of incremental and radical innovations in skin care products.
Effect on energy and macronutrient intake with partial replacement of external food supply by in‐house cooking at a nursing home for older people inSweden
Authors: Tieva Åse , Persson Evelina , Rhodin Anders , Sköldunger Anders , Pettersén Sigrid , Jonsäll Anette , Hörnell Agneta 
Published: February 2015

AbstractAn increased awareness of the importance of nutrition for older people's health and quality of life has underpinned projects and quality improvements for the meal situation in care establishments. The present study took place in a nursing home in a village outside an average‐sized town situated in mid‐Sweden. Care staff had initiated a change from external catered meals to purchase the food and cook the main meals themselves. The intention was to increase flexibility in accommodating the requests and needs of the elderly and, in doing so, to achieve increased professional pride and satisfaction.To ensure that no negative effects resulted for the residents in the nursing home, outcomes were evaluated through the present intervention study. The objective was to investigate whether and, if so, how their energy and nutrient intake and weight were affected. At the start, only one main hot meal was exchanged for home cooking to avoid work load problems as no increased costs were allowed and no extra staff were to be recruited.The study population consisted of 21 residents, aged 69–97 years. Weight, energy and nutrient intake were recorded before and during the intervention by 3‐day food records validated by Goldberg's cutoff method. The same 3 days of the week—Sunday to Tuesday—and the same menus were used for both measurement periods.At group level, the energy intake corresponded to the estimated energy requirements, both at baseline and at follow‐up, although the intervention resulted in a significantly higher energy intake from the meals cooked in the ward kitchens. Two‐thirds of the residents (n = 13) slightly increased in weight from baseline to follow‐up, while two participants (with body mass index 27.5 kg/m2and 33.5 kg/m2, respectively) lost 5.0 kg and 6.9 kg, respectively. The total protein intake was insufficient both at baseline and follow‐up and only met the participants' needs to 81 ± 22% and 83 ± 26%, respectively.In conclusion, the intervention resulted in no adverse consequences for participants in terms of energy and nutrient intake. Most participants were weight stable or had small increases in weight, and the greatest weight gain was observed in the lighter clients. The low protein intake at both time points causes concern and suggests the need for further nutritional interventions to optimize older people's protein intake.
The Hawke’s Bay Condom Card Scheme: a qualitative study of the views of service providers on increased, discreet access for youth to free condoms
Authors: Ryder Hollie , Aspden Trudi , Sheridan Janie 
Published: February 2015

Abstract

Objectives
The incidence of sexually transmitted infections and unplanned pregnancies in adolescence is of concern. The Hawke’s Bay District Health Board, New Zealand, set up a pilot condom card scheme (‘the Scheme’) to allow 13- to 24-year-olds, deemed suitable for the Scheme, to access free condoms from pharmacies on presentation of a Condom Card. Our study explored the views of service providers of a pilot Condom Card Scheme.

Methods
Qualitative interviews were conducted with 17 service providers (nurses, pharmacists, pharmacy staff) between February and April 2013.

Key findings
Our findings showed that the Scheme was viewed positively by service providers, who indicated almost universal support for the Scheme to continue. However, participants noted a perceived lack of advertising, low number of sites for collection of condoms, lack of flexibility of the Scheme’s criteria relating to who could access the scheme and issues with some pharmacy service providers, all of which led to a number of recommendations for improving the Scheme.

Conclusions
The views of service providers indicate broad support for the continuation of the Scheme. Canvassing young people’s suggestions for improving the Scheme is also essential.
Tadalafil 5 mg once daily for the treatment of Asian men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: Analyses of data pooled from three randomized, double‐blind, placebo‐controlled studies
Authors: Nishizawa Osamu , Yoshida Masaki , Takeda Masayuki , Yokoyama Osamu , Morisaki Yoji , Murakami Masahiro , Viktrup Lars 
Published: February 2015

ObjectivesAssess the efficacy and safety of tadalafil 5 mg once‐daily in Asian men with lower urinary tract symptoms by pooling data from three clinical studies.MethodsData on 1199 Japanese, Korean, and Taiwanese men given tadalafil 5 mg (n = 601) or placebo (n = 598) were pooled from three double‐blind, placebo‐controlled, 12‐week studies. Efficacy measures included International Prostate Symptom Score, and Patient and Clinician Global Impressions of Improvement. These measures were also assessed for patient subgroups (age categories, baseline disease severity and/or prostate volume, prior alpha‐blocker treatment). Safety measures included adverse events, including those in selected body systems. Efficacy measure changes throughout treatment were assessed by mixed‐effect model repeated‐measures analysis; baseline to end‐point changes for the total population and subgroups were evaluated by analysis of covariance.ResultsTadalafil 5 mg led to significant improvement (vs placebo) in all International Prostate Symptom Scores at all time‐points (week 4 P ≤ 0.013 for all measures; week 8 P ≤ 0.005, week 12 P < 0.001). End‐point results for both global impressions scales also favored tadalafil (both P < 0.001 vs placebo). Tadalafil efficacy was similar between patient subgroups of varied disease severity (interaction P = 0.097), prior alpha‐blocker use (P = 0.580), and prostate volume (P = 0.921). The drug was slightly less effective in older men (interaction P = 0.042). No unexpected adverse events were reported, and no meaningful adverse effects were observed in visual, auditory, or cardiovascular systems.ConclusionsTadalafil 5 mg once‐daily for 12 weeks is efficacious and safe in Asian men with lower urinary tract symptoms. Tadalafil is also effective in men of different ages, disease severity, prior alpha‐blocker exposure, and prostate volumes.
Commentary: Developmental origins of autism and ADHD – a commentary on Johnson et al. (2015)
Authors: Nelson Charles A. 
Published: February 2015

Autism (autistic spectrum disorder, ASD) and attention deficit hyperactivity disorder (ADHD) are two highly prevalent neurodevelopmental disorders. Current estimates for autism exceed 1% For ADHD, the 2013 US‐based life time prevalence figure is 11%. Both disorders are also highly heritable. Intriguingly, approximately 50% of children with ASD also meet criteria for ADHD. Between their high heritability and comorbidity, some have wondered whether these two seemingly different disorders might in fact be related at some deep neurobiological level. The notion that these two disorders may be related is surprising when one considers the fact that autism generally appears in the first 1–2 years of life, whereas it is virtually impossible to identify ADHD during this time frame; indeed, inattentiveness and hyperactivity tend to be traits that are shared by nearly all toddlers, making a stable diagnosis of ADHD virtually impossible until early childhood (although a reliable diagnosis can generally be made during the preschool period). Like many neurodevelopmental disorders, early identification and early treatment are essential to easing the life time burden of these disorders. Of course, early treatment is predicated on early identification and it is for this reason that the review article by Johnson and colleagues is so intriguing, as it sets out to determine whether these disorders can be identified in the infancy period. It also raises a number of puzzling issues that remain undiscussed.