bluuebunny/crossref_metadata_2025_split huggingface dataset:
Laying the foundation for a core set of the International Classification of Functioning, Disability and Health for community-dwelling adults aged 75 years and above in general practice: a study protocol
Authors: Tomandl Johanna , Book Stephanie , Gotthardt Susann , Heinmueller Stefan , Graessel Elmar , Freiberger Ellen , Kuehlein Thomas , Hueber Susann , Hoyer Stefanie 
Published: August 2018

IntroductionWith the medical focus on disease, the problem of overdiagnosis inevitably increases with ageing. Considering the functional health of patients might help to discriminate between necessary and unnecessary medicine. The International Classification of Functioning, Disability and Health (ICF) is an internationally recognised tool for describing functional health. However, it is too detailed to be used in primary care practices. Consequently, the aim of this study is to identify relevant codes for an ICF core set for community-dwelling older adults (75 years and above) in primary care.Methods and analysisThe study will follow the methodology proposed by the ICF Research Branch to identify relevant concepts from different perspectives: (1) Research perspective: A systematic review of studies focusing on functional health in old age will be conducted in different databases. Relevant concepts will be extracted from the publications. (2) Patients’ perspective: Relevant areas of functioning and disability will be identified conducting qualitative interviews and focus groups with community-dwelling older persons. The interviews will be transcribed verbatim and analysed using the documentary method of interpretation. (3) Experts’ perspective: An online survey with open-ended questions will be conducted. Answers will be analysed using the qualitative content analysis of Mayring. (4) Clinical perspective: A cross-sectional empirical study will be performed to assess the health status of community-dwelling older adults using the extended ICF checklist and other measurement tools.Relevant concepts identified in each study will be linked to ICF categories resulting in four preliminary core sets.Ethics and disseminationEthical approval for the study was obtained (90_17B). All participants will provide written informed consent. Data will be pseudonymised for analysis. Results will be disseminated by conference presentations and journal publications.Trial registration numberProjektdatenbank Versorgungsforschung Deutschland: VfD_17_003833,Clinicaltrials.gov:NCT03384732and PROSPERO: CRD42017067784.
Effects of interpregnancy interval on pregnancy complications: protocol for systematic review and meta-analysis
Authors: Gebremedhin Amanuel Tesfay , Regan Annette K , Malacova Eva , Marinovich M Luke , Ball Stephen , Foo Damien , Pereira Gavin 
Published: August 2018

IntroductionInterpregnancy interval (IPI) is the length of time between a birth and conception of the next pregnancy. Evidence suggests that both short and long IPIs are at increased risk of adverse pregnancy and perinatal outcomes. Relatively less attention has been directed towards investigating the effect of IPI on pregnancy complications, and the studies that have been conducted have shown mixed results.This systematic review will aim to provide an update to the most recent available evidence on the effect of IPI on pregnancy complications.Method and analysisWe will search electronic databases such as Ovid/MEDLINE, EMBASE, CINAHL, Scopus, Web of Science and PubMed to identify peer-reviewed articles on the effects of IPI on pregnancy complications. We will include articles published from start of indexing until 12 February 2018 without any restriction to geographic setting. We will limit the search to literature published in English language and human subjects. Two independent reviewers will screen titles and abstracts and select full-text articles that meet the eligibility criteria. The Newcastle-Ottawa tool will be used to assess quality of observational studies. Where data permit, meta-analyses will be performed for individual pregnancy complications. A subgroup analyses by country categories (high-income vs low and middle-income countries) based on World Bank income group will be performed. Where meta-analysis is not possible, we will provide a description of data without further attempt to quantitatively pool results.Ethics and disseminationFormal ethical approval is not required as primary data will not be collected. The results will be published in peer-reviewed journals and presented at national and international conferences.PROSPERO registration numberCRD42018088578.
Using routinely collected data to understand and predict adverse outcomes in opioid agonist treatment: Protocol for the Opioid Agonist Treatment Safety (OATS) Study
Authors: Larney Sarah , Hickman Matthew , Fiellin David A , Dobbins Timothy , Nielsen Suzanne , Jones Nicola R , Mattick Richard P , Ali Robert , Degenhardt Louisa 
Published: August 2018

IntroductionNorth America is amid an opioid use epidemic. Opioid agonist treatment (OAT) effectively reduces extramedical opioid use and related harms. As with all pharmacological treatments, there are risks associated with OAT, including fatal overdose. There is a need to better understand risk for adverse outcomes during and after OAT, and for innovative approaches to identifying people at greatest risk of adverse outcomes. The Opioid Agonist Treatment and Safety study aims to address these questions so as to inform the expansion of OAT in the USA.Methods and analysisThis is a retrospective cohort study using linked, routinely collected health data for all people seeking OAT in New South Wales, Australia, between 2001 and 2017. Linked data include hospitalisation, emergency department presentation, mental health diagnoses, incarceration and mortality. We will use standard regression techniques to model the magnitude and risk factors for adverse outcomes (eg, mortality, unplanned hospitalisation and emergency department presentation, and unplanned treatment cessation) during and after OAT, and machine learning approaches to develop a risk-prediction model.Ethics and disseminationThis study has been approved by the Population and Health Services Research Ethics Committee (2018HRE0205). Results will be reported in accordance with the REporting of studies Conducted using Observational Routinely-collected health Data statement.
Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data
Authors: Kwakkenbos Linda , Imran Mahrukh , McCord Kimberly A , Sampson Margaret , Fröbert Ole , Gale Chris , Hemkens Lars G , Langan Sinead M , Moher David , Relton Clare , Zwarenstein Merrick , Benchimol Eric I , Boutron Isabelle , Campbell Marion K , Erlinge David , Jawad Sena , Ravaud Philippe , Rice Danielle B , Sauve Maureen , van Staa Tjeerd P , Thabane Lehana , Uher Rudolf , Verkooijen Helena M , Juszczak Edmund , Thombs Brett D 
Published: August 2018

IntroductionRandomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data.Methods and analysisIn separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data.Ethics and disseminationThe proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.
Use of contraceptives and uptake of long-acting reversible contraception among postpartum women in rural China
Authors: Kang Chuyun , Li Peng , Liu Xiaoli , Ding Yuan , Wang Xiaoye , Zhou Hong 
Published: August 2018

BackgroundPregnancies have been increasing since the universal two-child policy in China was announced and thus the prevention of short inter-pregnancy intervals has become more important. However, little is known about contraceptive use among postpartum women in rural areas of China. This study investigated the current situation and factors associated with contraceptive use, especially long-acting reversible contraception (LARC) practice among postpartum women.Study designA cross-sectional study was conducted with a probability proportionate to size (PPS) sampling method in Shimen County of Hunan province with 423 mothers whose youngest child was aged under 2 years. A questionnaire was used to collect information on participants’ demographics, reproductive history and contraceptive use.ResultsThe rate of using all contraceptive methods was 66.4% in the study group and the rate of using LARC was 9.9%. Statistically significant predictors of contraceptive use were: no breastfeeding, no intention of having another child, and education beyond high school. Statistically significant predictors of LARC utilisation were: vaginal delivery, at least one child before the index delivery, and no breastfeeding.ConclusionsThe utilisation rate of postpartum contraception, especially LARC, was relatively low in rural China. The benefits of LARC have not been realised and breastfeeding is still incorrectly believed to be a definitely reliable method of contraception. Thus, health education and contraceptive knowledge and regulations need to be updated and enhanced based on research evidence, for increased adoption of postpartum contraception in rural China.
Petrology of Jurassic and Cretaceous basaltic formations from the Parnaíba Basin, NE Brazil: correlations and associations with large igneous provinces
Authors: Oliveira Alisson L. , Pimentel Márcio M. , Fuck Reinhardt A. , Oliveira Diógenes C. 
Published: August 2018

Abstract

The basaltic Mosquito and Sardinha formations in the Parnaíba Basin are related to the opening of the Atlantic Ocean at the Triassic–Jurassic boundary and in the early Cretaceous, respectively. The Mosquito Formation consists of tholeiitic flows with both high-Ti (>1.5 wt%) and low-Ti (<1.5 wt%) compositions and the petrogenetic characteristics of enriched mantle reservoirs. The Mosquito Formation basalts have an initial
87
Sr/
86
Sr isotopic composition of 0.70296–0.70841 and a low Nd isotopic composition (0.512245–0.512677) associated with an enrichment in large ion lithophile and high field strength elements relative to primitive mantle compositions. The Sardinha Formation is composed of high-Ti and low-Ti tholeiitic dykes with subordinate alkali basalts. The Sardinha Formation rocks have trace element and isotopic features associated with enriched mantle end-members. The initial isotopic compositions range from 0.702859 to 0.706703 and 0.512184 to 0.512671 for
87
Sr/
86
Sr and
143
Nd/
144
Nd, respectively. The concentrations of large ion lithophile and high field strength elements are elevated relative to primitive mantle values. Although the Mosquito and Sardinha formations share some similarities, they can be differentiated by their unique petrographic characteristics and trace element concentrations. These differences allow the discrimination of the basaltic magmatism in the Parnaíba Basin and their association with large igneous provinces, such as the Central Atlantic Magmatic Province or the Paraná–Etendeka Magmatic Province.

Supplementary material:
Microprobe analyses for clinopyroxene (Table A1), plagioclase (Table A2) and olivine (Table A3) for the Mosquito and Sardinha formations, along with mixing calculation parameters for the geochemical model (Table A4) are available at:
https://doi.org/10.6084/m9.figshare.c.3985437
Phase I Study of the Investigational Aurora A Kinase Inhibitor Alisertib plus Rituximab or Rituximab/Vincristine in Relapsed/Refractory Aggressive B-cell Lymphoma
Authors: Kelly Kevin R. , Friedberg Jonathan W. , Park Steven I. , McDonagh Kevin , Hayslip John , Persky Daniel , Ruan Jia , Puvvada Soham , Rosen Peter , Iyer Swaminathan Padmanabhan , Stefanovic Alexandra , Bernstein Steven H. , Weitman Steven , Karnad Anand , Monohan Gregory , VanderWalde Ari , Mena Raul , Schmelz Monika , Spier Catherine , Groshen Susan , Venkatakrishnan Karthik , Zhou Xiaofei , Sheldon-Waniga Emily , Leonard E. Jane , Mahadevan Daruka 
Published: August 2018

Abstract

Purpose:
The aurora A kinase inhibitor alisertib demonstrated single-agent clinical activity and preclinical synergy with vincristine/rituximab in B-cell non-Hodgkin lymphoma (B-NHL). This phase I study aimed to determine the safety and recommended phase II dose (RP2D) of alisertib in combination with rituximab ± vincristine in patients with relapsed/refractory aggressive B-NHL.

Patients and Methods:
Patients with relapsed/refractory, diffuse, large, or other aggressive B-NHL received oral alisertib 50 mg b.i.d. days 1 to 7, plus i.v. rituximab 375 mg/m2 on day 1, for up to eight 21-day cycles (MR). Patients in subsequent cohorts (3 + 3 design) received increasing doses of alisertib (30 mg starting dose; 10 mg increments) b.i.d. days 1 to 7 plus rituximab and vincristine [1.4 mg/m2 (maximum 2 mg) days 1, 8] for 8 cycles (MRV). Patients benefiting could continue single-agent alisertib beyond 8 cycles. Cell-of-origin and MYC/BCL2 IHC was performed on available archival tissue.

Results:
Forty-five patients participated. The alisertib RP2D for MR was 50 mg b.i.d. For MRV (n = 32), the RP2D was determined as 40 mg b.i.d. [1 dose-limiting toxicity (DLT) at 40 mg; 2 DLTs at 50 mg]. Drug-related adverse events were reported in 89% of patients, the most common was neutropenia (47%). Seven patients had complete responses (CR), 7 had partial responses (PRs); 9 of 20 (45%) patients at the MRV RP2D responded (4 CRs, 5 PRs), all with non–germinal center B-cell (GCB) diffuse large B-cell lymphoma (DLBCL).

Conclusions:
The combination of alisertib 50 mg b.i.d. plus rituximab or alisertib 40 mg b.i.d. plus rituximab and vincristine was well tolerated and demonstrated activity in non-GCB DLBCL.
Family History of Breast or Prostate Cancer and Prostate Cancer Risk
Authors: Barber Lauren , Gerke Travis , Markt Sarah C. , Peisch Samuel F. , Wilson Kathryn M. , Ahearn Thomas , Giovannucci Edward , Parmigiani Giovanni , Mucci Lorelei A. 
Published: August 2018

Abstract

Purpose:
Breast and prostate cancer co-occur in families, and women with a family history of prostate cancer are at increased breast cancer risk. Prostate cancer is among the most heritable cancers, but few studies have investigated its association with familial breast cancer. The objective of this study is to investigate the extent to which familial breast or prostate cancer in first-degree relatives increases prostate cancer risk.

Experimental Design:
A prospective study of 37,002 U.S. men in the Health Professionals Follow-up Study. During the 16-year follow-up to 2012, 4,208 total and 344 lethal cases were diagnosed. Using cause-specific hazards regression, we estimated the multivariable HRs and 95% confidence intervals (CI) for associations between familial breast or prostate cancer and total and lethal prostate cancer.

Results:
Those with familial breast cancer had a 21% greater risk of prostate cancer overall (95% CI, 1.10–1.34), and a 34% greater risk of lethal disease (HR 1.34; 95% CI, 0.96–1.89). Family history of prostate cancer alone was associated with a 68% increased risk of total disease (95% CI, 1.53–1.83) and a 72% increased risk of lethal disease (95% CI, 1.25–2.38). Men with a family history of both cancers were also at elevated risk.

Conclusions:
Our study found that men with a family history of breast or prostate cancer had elevated prostate cancer risks, including risk of lethal disease. These findings have translational relevance for cancer risk prediction in men.
Circulating Biomarkers and Resistance to Endocrine Therapy in Metastatic Breast Cancers: Correlative Results from AZD9496 Oral SERD Phase I Trial
Authors: Paoletti Costanza , Schiavon Gaia , Dolce Emily M. , Darga Elizabeth P. , Carr T. Hedley , Geradts Joseph , Hoch Matthias , Klinowska Teresa , Lindemann Justin , Marshall Gayle , Morgan Shethah , Patel Parul , Rowlands Vicky , Sathiyayogan Nitharsan , Aung Kimberly , Hamilton Erika , Patel Manish , Armstrong Anne , Jhaveri Komal , Im Seock-Ah , Iqbal Nadia , Butt Fouziah , Dive Caroline , Harrington Elizabeth A. , Barrett J. Carl , Baird Richard , Hayes Daniel F. 
Published: August 2018

AbstractPurpose:Common resistance mechanisms to endocrine therapy (ET) in estrogen receptor (ER)–positive metastatic breast cancers include, among others, ER loss and acquired activating mutations in the ligand-binding domain of the ER gene (ESR1LBDm). ESR1 mutational mediated resistance may be overcome by selective ER degraders (SERD). During the first-in-human study of oral SERD AZD9496, early changes in circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) were explored as potential noninvasive tools, alongside paired tumor biopsies, to assess pharmacodynamics and early efficacy.Experimental Design:CTC were enumerated/phenotyped for ER and Ki67 using CellSearch in serial blood draws. ctDNA was assessed for the most common ESR1LBDm by droplet digital PCR (BioRad).Results:Before starting AZD9496, 11 of 43 (25%) patients had ≥5 CTC/7.5 mL whole blood (WB), none of whom underwent reduction to &lt;5 CTC/7.5 mL WB on C1D15. Five of 11 patients had baseline CTC-ER+, two of whom had CTC-ER+ reduction. CTC-Ki67 status did not change appreciably. Patients with ≥5 CTC/7.5 mL WB before treatment had worse progression-free survival (PFS) than patients with &lt;5 CTC (P = 0.0003). Fourteen of 45 (31%) patients had ESR1LBDm+ ctDNA at baseline, five of whom had ≥2 unique mutations. Baseline ESR1LBDm status was not prognostic. Patients with persistently elevated CTC and/or ESR1LBDm+ ctDNA at C1D15 had worse PFS than patients who did not (P = 0.0007).Conclusions:Elevated CTC at baseline was a strong prognostic factor in this cohort. Early on-treatment changes were observed in CTC-ER+ and ESR1LBDm+ ctDNA, but not in overall CTC number. Integrating multiple biomarkers in prospective trials may improve outcome prediction and ET resistance mechanisms' identification over a single biomarker.
Phage Display-Derived Peptide-Based Dual-Modality Imaging Probe for Bladder Cancer Diagnosis and Resection Postinstillation: A Preclinical Study
Authors: Peng Li , Shang Wenting , Guo Pengyu , He Kunshan , Wang Hongzhi , Han Ziyu , Jiang Hongmei , Tian Jie , Wang Kun , Xu Wanhai 
Published: August 2018

Abstract
Bladder cancer is a common human malignancy. Conventional ultrasound and white-light cystoscopy are often used for bladder cancer diagnosis and resection, but insufficient specificity results in a high bladder cancer recurrence rate. New strategies for the diagnosis and resection of bladder cancer are needed. In this study, we developed a highly specific peptide-based probe for bladder cancer photoacoustic imaging (PAI) diagnosis and near-infrared (NIR)-imaging-guided resection after instillation. A bladder cancer–specific peptide (PLSWT7) was selected by in vivo phage-display technology and labeled with IRDye800CW to synthesize a bladder cancer–specific dual-modality imaging (DMI) probe (PLSWT7-DMI). The feasibility of PLSWT7-DMI–based dual-modality PAI-NIR imaging was assessed in vitro, in mouse models, and ex vivo human bladders. An air-pouch bladder cancer (APBC) model suitable for probe instillation was established to evaluate the probe-based bladder cancer PAI diagnosis and NIR-imaging–guided resection. Human bladders were used to assess whether the PLSWT7-DMI–based DMI strategy is a translatable approach for bladder cancer detection and resection. The probe exhibited excellent selectivity and specificity both in vitro and in vivo. Postinstillation of the probe, tumors &lt;3 mm were detectable by PAI, and NIR-imaging–guided tumor resection decreased the bladder cancer recurrence rate by 90% and increased the survival in the mouse model. Additionally, ex vivo NIR imaging of human bladders indicated that PLSWT7-DMI–based imaging would potentially allow precise resection of bladder cancer in clinical settings. This PLSWT7-DMI–based DMI strategy was a translatable approach for bladder cancer diagnosis and resection and could potentially lower the bladder cancer recurrence rate. Mol Cancer Ther; 17(10); 2100–11. ©2018 AACR.
Suppression of Breast Cancer Stem Cells and Tumor Growth by the RUNX1 Transcription Factor
Authors: Hong Deli , Fritz Andrew J. , Finstad Kristiaan H. , Fitzgerald Mark P. , Weinheimer Adam , Viens Adam L. , Ramsey Jon , Stein Janet L. , Lian Jane B. , Stein Gary S. 
Published: August 2018

AbstractBreast cancer remains the most common malignant disease in women worldwide. Despite advances in detection and therapies, studies are still needed to understand the mechanisms underlying this cancer. Cancer stem cells (CSC) play an important role in tumor formation, growth, drug resistance, and recurrence. Here, it is demonstrated that the transcription factor RUNX1, well known as essential for hematopoietic differentiation, represses the breast cancer stem cell (BCSC) phenotype and suppresses tumor growth in vivo. The current studies show that BCSCs sorted from premalignant breast cancer cells exhibit decreased RUNX1 levels, whereas ectopic expression of RUNX1 suppresses tumorsphere formation and reduces the BCSC population. RUNX1 ectopic expression in breast cancer cells reduces migration, invasion, and in vivo tumor growth (57%) in mouse mammary fat pad. Mechanistically, RUNX1 functions to suppress breast cancer tumor growth through repression of CSC activity and direct inhibition of ZEB1 expression. Consistent with these cellular and biochemical results, clinical findings using patient specimens reveal that the highest RUNX1 levels occur in normal mammary epithelial cells and that low RUNX1 expression in tumors is associated with poor patient survival.Implications:The key finding that RUNX1 represses stemness in several breast cancer cell lines points to the importance of RUNX1 in other solid tumors where RUNX1 may regulate CSC properties.