bluuebunny/crossref_metadata_2025_split huggingface dataset:
Early changes in scores of chronic damage on transplant kidney protocol biopsies reflect donor characteristics, but not future graft function
Authors: Caplin Ben , Veighey Kristin , Mahenderan Arundathi , Manook Miriam , Henry Joanne , Nitsch Dorothea , Harber Mark , Dupont Peter , Wheeler David C. , Jones Gareth , Fernando Bimbi , Howie Alexander J. , Veitch Peter 
Published: October 2013

AbstractThe amount of irreversible injury on renal allograft biopsy predicts function, but little is known about the early evolution of this damage. In a single‐center cohort, we examined the relationship between donor‐, recipient‐, and transplantation‐associated factors and change in a morphometric index of chronic damage (ICD) between protocol biopsies performed at implantation and at 2–3 months. We then investigated whether early delta ICD predicted subsequent biochemical outcomes. We found little evidence to support differences between the study group, who had undergone serial biopsies, and a contemporaneous control group, who had not. In allografts with serial biopsies (n = 162), there was an increase in ICD between implantation (median: 2%, IQR:0–8) and 2–3 months post‐transplant (median 8% IQR:4–15; p < 0.0001). Donation from younger or live donors was independently associated with smaller early post‐transplant increases in ICD. There was no evidence for a difference in delta ICD between donation after cardiac death vs. donation after brain death, nor association with length of cold ischemia. After adjustment for GFR at the time of the second biopsy, delta ICD after three months did not predict allograft function at one yr. These findings suggest that graft damage develops shortly after transplantation and reflects donor factors, but does not predict future biochemical outcomes.
Poor sleep in organ transplant recipients: self‐reports and actigraphy
Authors: Reilly‐Spong M. , Park T. , Gross C. R. 
Published: October 2013

AbstractSolid organ transplant recipients are at increased risk of poor sleep due to pharmacotherapy and co‐morbidities, but sleep problems are often unrecognized and untreated. Study aims were to measure rates of occurrence, characteristics, and correlates of poor sleep in recipients. The Pittsburgh Sleep Quality Index (PSQI) and sleep parameters measured by wrist actigraphy were obtained at baseline from 143 kidney, liver, heart, lung, or pancreas transplant recipients enrolled in a psychosocial intervention trial to improve symptoms and quality of life. Rates of poor sleep were determined using accepted clinical cutoffs; 41% (58 of 143) were poor sleepers (PSQI > 8) and 36% used sleep medications in the past month. Fifteen percent reported having obstructive sleep apnea (OSA) and 4% reported restless legs syndrome (RLS). Based on actigraphy (n = 73), 69% lacked sleep efficiency (SE), 32% took >30 min to fall asleep, 88% awakened during the night for more than 30 min, and 25% slept less than six h per night. Obesity and use of psychotropics or sleep medications, and pain were independent risk factors for poor objectively measured sleep. Poor sleep is an undertreated problem in transplantation. Screening for sleep problems and behavioral therapies with sleep hygiene instruction may benefit recipients.
Rituximab for Non‐Hodgkin's Lymphoma: A Story of Rapid Success in Translation
Authors: Harrison Andrew M. , Thalji Nassir M. , Greenberg Alexandra J. , Tapia Carmen J. , Windebank Anthony J. 
Published: October 2013

AbstractTranslational stories range from straightforward to complex. In this commentary, the story of the rapid and successful translation of rituximab therapy for the treatment of non‐Hodgkin's lymphoma (NHL) is examined. Development of this monoclonal antibody therapy began in the late 1980s. In 1994, rituximab received its first approval for the treatment of NHL by the United States Food and Drug Administration (FDA). Rituximab has since been approved for additional indications and has transformed medical practice. However, the social and political implications of these rapid successes are only beginning to become clear. In this commentary, key events in the rapid translation of rituximab from the bench to bedside are highlighted and placed into this historical framework. To accomplish this, the story of rituximab is divided into the following six topics, which we believe to be widely applicable to case studies of translation: (1) underlying disease, (2) key basic science, (3) key clinical studies in translation, (4) FDA approval process, (5) changes to medical practice, and (6) the social and political influences on translation.
Measurement of Social Capital among Clinical Research Trainees
Authors: Primack Brian A. , Colditz Jason B. , Cohen Elan , Switzer Galen E. , Robinson Georgeanna F.W.B. , Seltzer Deborah L. , Rubio Doris M. , Kapoor Wishwa N. 
Published: October 2013

AbstractWhile physical and human capital are established as important predictors of success among early‐career clinical investigators, less is known about the role of social capital. The authors aimed to develop a brief scale to assess social capital in this population and test its reliability and validity. A three‐item assessment was developed based on a conceptual framework and measures of social capital from other fields and was administered to 414 clinical research trainees at the University of Pittsburgh in 2007–2012. The measure exhibited good internal consistency reliability (α = 0.71) and a normal distribution. On a 10‐point scale, mean social capital was 6.4 (SD = 1.7). Social capital was significantly associated with 7 of the 9 expected constructs: sex, age, confidence in research skills, work‐related motivation, burnout, and social support. Exploratory multivariable regression analysis demonstrated that social capital was most strongly associated with higher research confidence (β = 0.35, p < 0.001), higher extrinsic motivation (β = 0.50, p = 0.003), and lower burnout (ptrend = 0.02). This three‐item scale measures social capital in this population with adequate internal consistency reliability, face validity, and construct validity. This brief assessment provides a tool that may be valuable to benchmark social capital of clinical research trainees and to better contextualize programmatic and trainee outcomes.
The Design and Conduct of a Community‐Based Registry and Biorepository: A Focus on Cardiometabolic Health in Latinos
Authors: Shaibi Gabriel Q. , Coletta Dawn K. , Vital Veronica , Mandarino Lawrence J. 
Published: October 2013

AbstractBackgroundLatinos are disproportionately impacted by obesity and type 2 diabetes but remain underrepresented in biomedical research. Therefore, the purpose of this project was to develop a research registry and biorepository to examine cardiometabolic disease risk in the Latino community of Phoenix, Arizona. The overarching goal was to establish the research infrastructure that would encourage transdisciplinary research regarding the biocultural mechanisms of obesity‐related health disparities and facilitate access to this research for the Latino community.MethodsPrior to recruitment, key stakeholders from the local Latino community were engaged to develop a broad rapport within the community and seek advice regarding recruitment, enrollment, and follow‐up. Self‐identified community‐dwelling Latinos underwent a comprehensive cardiometabolic health assessment that included anthropometrics, a fasting laboratory panel, and a 2‐hour oral glucose tolerance test with measures of insulin and glucose to estimate insulin action and secretion. Separate consent was requested for future contact and banking of serum, DNA, and RNA. Research collaborations were sought out based on the cultural and metabolic profile of participants, faculty research agendas, and the potential for generating hypotheses.ResultsA total of 667 participants (20.4% children, and 79.6% adults) were enrolled with 97% consenting to the registry and 94% to banking of samples. The prevalence of overweight/obesity was 50% in children and 81% in adults. Nearly 20% of children and more than 45% of the adults exhibited some degree of hyperglycemia. To date, more than 15 research projects have been supported through this infrastructure and have included projects on the molecular biology of insulin resistance to the sociocultural determinants of health behaviors and outcomes.ConclusionsThe high prevalence of obesity and cardiometabolic disease risk factors coupled with the overwhelming majority of participants consenting to be re‐contacted, highlights the importance of supporting research infrastructure to generate hypotheses about obesity‐related health in Latinos. Future studies that stem from the initial project will likely advance the limited understanding regarding the biocultural determinants of health disparities in the Latino community.
The differential diagnosis of CD8‐positive (“type D”) lymphomatoid papulosis
Authors: McQuitty Elizabeth , Curry Jonathan L. , Tetzlaff Michael T. , Prieto Victor G. , Duvic Madeleine , Torres‐Cabala Carlos 
Published: October 2013

BackgroundCutaneous CD8+ CD30+ lymphoproliferative lesions are difficult to classify and encompass entities that follow a benign course to overt lymphoma. In order to identify histopathologic criteria for lesions in this spectrum, a series of such cases was reviewed.MethodsTwenty‐eight biopsies from 27 patients with CD8+ CD30+ cutaneous lymphoid proliferations were evaluated.ResultsSeventeen cases were classified as lymphomatoid papulosis (LyP) ‘type D’, eight as cutaneous anaplastic large cell lymphoma (C‐ALCL) and two as CD8+ mycosis fungoides (MF) with CD30 expression. Features of LyP included spongiosis and/or parakeratosis (90%), epidermotropism by large lymphocytes (90%), with (80%) or without (10%) small lymphocytes; wedge‐shaped infiltrate (70%) with perivascular (100%) and interstitial (80%) pattern; and relative uniformity of CD30+ large atypical cells (90%). C‐ALCL was characterized by ulceration (63%), epidermotropism restricted to small lymphocytes (100%), marked density (63%) and pleomorphism (62%) of CD30+ large atypical cells, and at least focal extension of infiltrate to subcutaneous tissue (88%). CD8+ CD30+ MF had vacuolar interface change and a lichenoid pattern (100%).ConclusionsWe concur with previous authors that distinction of CD8+ LyP from lymphoma in its differential diagnosis is difficult based on histopathology alone. Nonetheless, we propose that certain histopathologic clues may be helpful in this differential diagnosis.
Treatment expectations and satisfaction of treatment‐refractory opioid‐dependent patients in RIOTT, the Randomised Injectable Opiate Treatment Trial, the UK's first supervised injectable maintenance clinics
Authors: Groshkova Teodora , Metrebian Nicola , Hallam Christopher , Charles Vikki , Martin Anthea , Forzisi Luciana , Lintzeris Nicholas , Strang John 
Published: October 2013

AbstractIntroduction and AimsThe study investigates patients' pre‐treatment expectations of, and post‐treatment satisfaction with, supervised injectable opiate treatment delivered within UK's first such clinics within the Randomised Injectable Opiate Treatment Trial (RIOTT) (ISRCTN0133807).Design and MethodsData were collected from 127 chronic heroin addicts recruited to RIOTT and randomised to receive supervised injectable (heroin or methadone) treatment or optimised oral maintenance treatment at supervised injectable maintenance clinics in London, Darlington and Brighton.ResultsOf 127 RIOTT patients, 113 (89%) provided responses to structured enquiry about treatment expectations, and 94 (74%) subsequent responses about treatment satisfaction (at six months). Patients were hoping that injectable heroin treatment would: reduce substance misuse (81%); help achieve normality, routine and structure (16%); and increase education and work prospects (15%). At six months, an area of treatment satisfaction most commonly reported by all three trial groups was reduced substance misuse (supervised injectable heroin 59%, supervised injectable methadone 56%, optimised oral methadone 54%). Most found supervision acceptable, but some desired modifications were also identified.Discussion and ConclusionsPatients previously considered non‐responsive to treatment appear to have similar treatment expectations and aspirations as other drug users in treatment. Supervised injectable opioid treatment patients consistently reported treatment satisfaction but also that more could be done to optimise aspects of current arrangement. This raised the challenging issue of the extent to which opinions of patients need to be taken into consideration in shaping future treatment provision. Future research may need to examine the extent of expectations ‘fit’ and the relationship between treatment sought and received. [Groshkova T, Metrebian N, Hallam C, Charles V, Martin A, Forzisi L, Lintzeris N, Strang J. Treatment expectations and satisfaction of treatment‐refractory opioid dependent patients in Randomised Injectable Opiate Treatment Trial, the UK's first supervised injectable maintenance clinics. Drug Alcohol Rev 2013;32:566–573]
Is narrow‐band imaging useful for histological evaluation of gastric mucosa‐associated lymphoid tissue lymphoma after treatment?
Authors: Nonaka Kouichi , Ohata Ken , Matsuhashi Nobuyuki , Shimizu Michio , Arai Shin , Hiejima Yoshimitsu , Kita Hiroto 
Published: October 2013

Background and AimEndoscopic diagnosis of stomach mucosa‐associated lymphoid tissue (MALT) lymphoma is often difficult because few specific findings are indicated. Even when MALT lymphoma is suspected by endoscopy, it is still difficult to make a definitive diagnosis by biopsy because lymphoma cells sometimes distribute unevenly. We previously reported that a tree‐like appearance (TLA) is a characteristic finding of MALT lymphoma by narrow‐band imaging (NBI) magnifying endoscopy and it is valuable in the selection of an optimal biopsy site in MALT lymphoma. Here, we study the frequency of TLA and evaluate the relationship between the response to eradication therapy and TLA in MALT lymphoma.MethodsWe retrospectively examined the clinical background, endoscopic findings, response to eradication therapy, and Helicobacter pylori infection status of 16 patients diagnosed with MALT lymphoma who were referred to our hospital from April 2007 to August 2012. The regimen for eradicationtherapy consisted of rabeprazole, with amoxicillin and clarithromycin, all given for 7 days.ResultsTLA was found in 75% (12/16) and H. pylori infection in 75% (12/16) of patients diagnosed with MALT lymphoma by NBI magnifying endoscopy. In all complete regression (CR) patients after eradication treatment, the TLA finding had disappeared (100%); however, in the non‐CR patients, TLA remained the same as before the eradication therapy (P = 0.002).ConclusionThese results suggest that NBI magnifying endoscopy may be useful not only in the diagnosis but also in the evaluation of the response to eradication therapy of MALT lymphoma of the stomach.
Influences of vowel and tone variation on emergent word knowledge: a cross‐linguistic investigation
Authors: Singh Leher , Hui Tam Jun , Chan Calista , Golinkoff Roberta Michnick 
Published: October 2013

AbstractTo learn words, infants must be sensitive to native phonological contrast. While lexical tone predominates as a source of phonemic contrast in human languages, there has been little investigation of the influences of lexical tone on word learning. The present study investigates infants’ sensitivity to tone mispronunciations in two groups of infants. For one group (Chinese learners), tone is phonemic in their native language, and for the second group (English learners), tone is non‐phonemic and constituted suprasegmental variation. In Experiment 1, English learners were trained on novel word–object pairings and tested on their recognition of correct pronunciations, tone and vowel mispronunciations of these words at 18 and 24 months. In Experiment 2a, bilingual English‐Chinese learners were tested on a similar task translated into Chinese at the same age intervals. Results demonstrate that non‐tonal learners treated tonal and vowel substitutions alike as mispronunciations at 18 months but only treated vowel substitutions as mispronunciations at 24 months. Tonal learners treated both tonal and vowel substitutions as mispronunciations at both ages. In Experiment 2b, bilingual non‐tone language learners were tested on the same set of tasks replicating a similar set of results as monolingual non‐tone language learners (Experiment 1). Findings point to an early predisposition to treat tone as a defining characteristic of words regardless of its lexical relevance at 18 months. Between 18 and 24 months, learners appear to ascribe lexical relevance to tone in a language‐specific manner. The current study identifies the influences of tone variation on memories for newly learned words and the time period during which lexical tone – a highly frequent constituent of human languages – actually becomes lexical for early learners. Findings are contextualized with prevailing models of the developing lexicon.
Ophthalmic abnormalities in children with developmental coordination disorder
Authors: Creavin Alexandra L , Lingam Raghu , Northstone Kate , Williams Cathy 
Published: October 2013

AimTo explore associations between developmental coordination disorder (DCD) and ophthalmic abnormalities in children aged 7 to 8 years.MethodCross‐sectional analysis of data from the Avon Longitudinal Study of Parents and Children (ALSPAC), a UK birth cohort, was performed. DCD was defined according to DSM‐IV criteria. Children with neurological difficulties or IQ less than 70 were excluded. Ophthalmic abnormalities including visual acuity, refraction, and binocular function were assessed using standard tests. Children who achieved less than the 5th centile in the ALSPAC coordination test and either failed the National Curriculum handwriting test, or achieved less than the 10th centile in the Activities of Daily Living scale (ADL) were defined as having severe DCD, while those who scored between the 5th and 15th centiles in the coordination test and either failed the handwriting test, or achieved less than the 15th centile in the ADL were defined as having moderate DCD.ResultsComplete data were available for 7154 children. One hundred and twenty children (1.8%) met the criteria for severe DCD. A further 215 children had moderate DCD. Children with severe DCD were more likely to have the following: abnormal sensory fusion at near (odds ratio [95% confidence interval]) (1.98 [1.13–3.48]) and distance (2.59 [1.16–5.79]) and motor fusion (1.74 [1.07–2.84]); reduced stereoacuity (2.75 [1.78–4.23]); hypermetropia (2.29 [1.1–4.57]) and anisometropia (2.27 [1.13–4.60]). The majority of children found to have both DCD and a refractive error, had been previously prescribed glasses and wore them for the assessments (71%).InterpretationChildren with severe DCD had abnormalities in binocular vision, refractive error, and ocular alignment. We recommend that children with DCD be assessed for ocular abnormalities as early intervention may improve long‐term visual outcome. The impact of untreated ocular abnormalities such as refractive error on the accuracy of the diagnosis of DCD is difficult to ascertain and further work would be of benefit.
The optimal morning:evening ratio in total dose of twice‐daily biphasic insulin analogue in poorly controlled Type 2 diabetes: a 24‐week multi‐centre prospective, randomized controlled, open‐labelled clinical study
Authors: Jung C. H. , Park J.‐Y. , Cho J. H. , Yoon K.‐H. , Yang H. K. , Lee Y.‐H. , Cha B. S. , Lee B.‐W. 
Published: October 2013

AbstractAimsBiphasic insulin analogues are widely used in patients with Type 2 diabetes mellitus suboptimally controlled on oral anti‐diabetic drugs. Several topics in this area remain controversial, including how to divide the daily dose of biphasic insulin analogue. We aimed to determine the optimal dosing ratio of twice‐daily biphasic insulin analogue and to compare the glycaemic efficacy among groups of patients using different initial dosing ratios of biphasic insulin analogue.MethodsA total of 100 poorly controlled insulin‐naive subjects with Type 2 diabetes [HbA1c ≥ 58 mmol/mol, (7.5%)] on oral anti‐diabetic drugs were randomized into three groups according to initial morning:evening dosing ratio (group I, 50:50; group II, 55:45; group III, 60:40) of twice‐daily biphasic insulin analogue (biphasic insulin aspart 70/30, biphasic insulin aspart 30). The primary outcome measure was the difference in pre‐breakfast to pre‐dinner dose ratio at the end of the study.ResultsTwice‐daily biphasic insulin analogue showed a significant improvement in glycaemic control [HbA1c from 70 mmol/mol (8.6%) to 60 mmol/mol (7.6%)] after 24 weeks regardless of the initial dose ratio given. Despite the similar efficacy and safety profiles among three groups, morning dose was significantly increased (from 50:50 to 55:45–60:40) in group I after 24 weeks. However, there was no significant change in splitting ratio in groups II and III (with higher morning dose) over the 24‐week treatment period.ConclusionsThese results indicate that initiating twice‐daily biphasic insulin analogue on regimens with a higher dose before breakfast than before dinner (i.e. ratio approximately 55:45 to 60:40) might be more appropriate in Korean subjects with Type 2 diabetes.
Efficacy and safety of lixisenatide once daily vs. placebo in people with Type 2 diabetes insufficiently controlled on metformin (GetGoal‐F1)
Authors: Bolli G. B. , Munteanu M. , Dotsenko S. , Niemoeller E. , Boka G. , Wu Y. , Hanefeld M. 
Published: October 2013

AbstractAimsTo assess the efficacy and safety of one‐ and two‐step dose‐increase regimens of lixisenatide once daily in participants with Type 2 diabetes mellitus insufficiently controlled with metformin.MethodsThis was a randomized, double‐blind, placebo‐controlled, parallel‐group, multi‐centre study enrolling participants with Type 2 diabetes (n = 484) treated with metformin. Participants were randomized to receive either lixisenatide in a one‐step dose increase or a two‐step dose increase vs. placebo for 24 weeks, followed by a ≥ 52‐week variable double blind period. Primary outcome was HbA1c reduction at week 24.ResultsLixisenatide one‐/two‐step once daily significantly improved HbA1c at week 24 compared with placebo (P < 0.0001) and allowed more participants to achieve HbA1c < 53 mmol/mol (< 7.0%) (P ≤ 0.0005). Improvements were observed in fasting plasma glucose (–0.5/–0.6 vs. +0.1 mmol/l; P < 0.001) and body weight (–2.6/–2.7 vs. –1.6 kg; P < 0.005). At week 24, adverse events were reported by 67.7/70.8/65.6% of participants treated with lixisenatide one‐/two‐step/placebo, respectively—nausea and vomiting being reported most frequently. Symptomatic hypoglycaemia occurred in 1.9/2.5% of participants on one‐/two‐step lixisenatide and 0.6% with placebo, with no severe episodes. Lixisenatide continued to be efficacious and well tolerated during the variable double‐blind extension period of at least 52 weeks.ConclusionsLixisenatide one‐ or two‐step dose‐increase regimens significantly improved glycaemic control and decreased body weight over 24 weeks and during a long‐term extension period without increasing hypoglycaemia. The study confirmed that tolerability in the one‐step group was at least similar to the two‐step dose increase, with nausea/vomiting and hypoglycaemia frequency being lower in the one‐step regimen.