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Abstracts from 2020 national congress of the Italian Society of Hypertension (SIIA).

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… Department of Biostatistics and Research Support, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands; 7. Fourth Unit of Internal Medicine, University Hospital of Pisa, Pisa, Italy; 8. … Gobbo Stefano 1 , Ortolan Sara 1 , Gasperetti Andrea 1 , Ermolao Andrea 1 1-Department of Medicine, Sports and Exercise Medicine Division, University of Padova; Regional Center for Exercise Prescription in Chronic Diseases, Veneto Region, Italy; 2-Department of Cardiac, Thoracic and Vascular Sciences, Biostatistics …

Catheter-related thrombosis in cancer patients with tunnelled non-cuffed centrally inserted central catheters: a retrospective cohort study.

BACKGROUND: Peripherally inserted central catheters (PICCs) are widely used in oncology but are associated with higher rates of catheter-related thrombosis compared to other central venous access devices. Tunnelled non-cuffed centrally inserted central catheters (tnc-CICC) may offer a safer alternative in patient at high risk of thrombosis. METHODS: This retrospective cohort study evaluated 193 tnc-CICCs placed in 182 cancer patients at a tertiary oncology unit between January 2021 and December 2022. Primary outcomes is catheter-related thrombosis; secondary outcomes are procedural duration a

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… Laenen from the Leuven Biostatistics and Statistical Bioinformatics Centre (LBioStat) for assistance in the statistical analysis. …

Высокополосная оценка переносимого Ультра-Лоу-Полевой МРТ для многоразового склероза.

МРТ имеет решающее значение для многократного склероза (MS), однако относительное значение переносного ультранизкого поля МРТ (PULF-MRI) — технологии, которая обещает расширить доступ к МРТ, неизвестно. Мы оценивали обнаружение повреждений белой материи (WML) на PULF-MRI по сравнению с высокофилиальными МРТ (HF-MRI), сосредоточив внимание на слепых оценках, самоподготовке специалистов по оценке и многопланных приобретениях. МЕТОДЫ: Fifty-five Взрослые с MS прошли курс PULF-MRI после своего HF-MRI. Two Нейрорадиологи провели независимую оценку изображений PULF-MRI в процессе оценки, включая пер

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… Statistics were performed by S.V.O. and supervised by D.S.R., who is an adjunct professor of biostatistics at Johns Hopkins University. Images from 15 of 55 participants in this cohort were used in Arnold et al. [ 13 ]. …

A biobehavioral intervention to enhance recovery following hematopoietic cell transplantation: Protocol for a feasibility and acceptability randomized control trial.

BackgroundInsomnia, fatigue, and depression are among the most persistent and distressing concerns for hematologic cancer patients recovering from hematopoietic cell transplantation (HCT). This study will evaluate a novel behavioral intervention, Restoring Sleep and Energy after Transplant (ReSET), designed to alleviate insomnia, fatigue, and depression by improving rest-activity patterns. Evidence-based behavioral strategies to improve nighttime sleep and increase non-sedentary daytime activity will be combined to optimize 24-h rest-activity patterns.MethodsThe protocol herein evaluates the f

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… Rathouz: Conceptualization, methodology, biostatistics, writing – review and editing. Schell: Methodology, project administration, writing – review and editing. Callander: Methodology, resources, writing – review and editing. Hematti: Methodology, resources, writing – review and editing. …

Patient-reported symptom burden in routine oncology care: Examining racial and ethnic disparities.

BackgroundRacial and ethnic disparities are well-documented in cancer outcomes such as disease progression and survival, but less is known regarding potential disparities in symptom burden.AimsThe goal of this retrospective study was to examine differences in symptom burden by race and ethnicity in a large sample of cancer patients. We hypothesized that racial and ethnic minority patients would report greater symptom burden than non-Hispanic and White patients.Methods and resultsA total of 5798 cancer patients completed the Edmonton Symptom Assessment Scale-revised (ESAS-r-CSS) at least once a

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… Lee Moffitt Cancer Center: Biostatistics and Bioinformatics; Collaborative Data Services; and Participant Research, Interventions, and Measurement (PRISM). CONFLICT OF INTEREST B.D.G.: Personal fees from SureMed Compliance and Elly Health, Inc. …

The age-related impact of surviving sarcoma on health-related quality of life: data from the SURVSARC study.

BackgroundHealth-related quality of life (HRQoL) data of sarcoma survivors are scarce and the impact of age remains unclear. The aims of this population-based study were to (i) compare HRQoL scores amongst three age-groups [adolescents and young adults (AYA, aged 18-39 years), older adults (OA, aged 40-69 years) and elderly (aged ≥70 years)]; (ii) compare HRQoL of each sarcoma survivor age group with an age- and sex-matched normative population sample; (iii) determine factors associated with low HRQoL per age group.MethodsDutch sarcoma survivors, who were 2-10 years after diagnosis, were invit

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… Encyclopedia of Biostatistics. John Wiley & Sons; Chichester, England: 2005. 26. Cocks K., King M.T., Velikova G., Martyn St-James M., Fayers P.M., Brown J.M. …

FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia.

BackgroundThe optimal iron therapy regimen in patients with non-dialysis-dependent chronic kidney disease (CKD) is unknown.MethodsFerinject® assessment in patients with Iron deficiency anaemia and Non-Dialysis-dependent Chronic Kidney Disease (FIND-CKD) was a 56-week, open-label, multicentre, prospective and randomized study of 626 patients with non-dialysis-dependent CKD, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents (ESAs). Patients were randomized (1:1:2) to intravenous (IV) ferric carboxymaltose (FCM), targeting a higher (400-600 µg/L) or lower (100-200 µg/L)

Cardiovascular Adverse Events Associated With Bispecific T-Cell Engager Therapy.

BACKGROUND: Although some cancer immunotherapies have been linked to increased cardiovascular risk, data on T-cell engager (TCE) therapy-associated cardiovascular complications remain limited. OBJECTIVES: This study sought to characterize the incidence and factors associated with cardiovascular events (CVEs) and mortality during TCE therapy. METHODS: We conducted a dual-center retrospective study of patients with cancer treated with TCEs between 2016 and 2024. The cumulative incidence of on-treatment CVEs (heart failure, arrhythmias, myocardial infarction, stroke) and cardiovascular mortalit

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… Tutorial in biostatistics: competing risks and multi-state models. Stat Med. 2007;26(11):2389–2430. doi: 10.1002/sim.2712. 13. Salem J.E., Manouchehri A., Moey M., et al. …

Feasibility of decentralized real-world monitoring of SARS-CoV-2 booster vaccines and COVID-19 outcomes in myeloma.

AbstractPatients with multiple myeloma have an elevated risk of severe complications from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; COVID-19) infection. To demonstrate proof of concept for a pandemic preparedness and response network, the American Society of Hematology Research Collaborative Multiple Myeloma Program developed a prospective, decentralized study within a site-based provider network. In the COVID-19 outcomes in myeloma and the impact of vaccines (COSMIC) study, patients provided consent, permitted electronic health record data collection, completed patient-repo

Клиническое описание и социально-демографическая характеристика лиц, страдающих киберсексуальной зависимостью, в рамках долгосрочных программ терапевтической поддержки.

ЦЕЛЬ: Киберсексуальная зависимость и гиперсексуальное поведение представляют собой растущие проблемы в области психического здоровья во всем мире. В ходе этого исследования были проанализированы социально-демографические и клинические характеристики когорты мужчин, проходящих курс лечения, а также была изучена взаимосвязь между продолжительностью терапевтической помощи и симптоматической строгостью. МЕТОД: В рамках программ терапевтической поддержки было проведено исследование по наблюдению, описательному и сквозному изучению с участием преимущественно мужской клинической группы (n = 27; 26 му

Действенность и безопасность цифрового таперинга для пациентов, которым предписывается опиоид после хирургической операции: протокол для перспективного исследования кохарта.

Предыстория 300 million Каждый год во всем мире проводятся хирургические операции, и опиоиды по-прежнему являются одним из основных методов борьбы с острой послеоперационной болью. Исследования показали, что значительное число пациентов не прекращают опиоидное лечение и продолжают использовать опиоиды в течение месяцев или даже лет после операции. Известная практика применения опиоидов рецептурного отпуска и управления ими является частью нынешних клинических руководящих принципов безопасного прописывания. Каждый пациент должен получать тщательный контроль, образование и план скрининга, когда

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… Fundamentals of Biostatistics 7th Edition. Boston, MA: Cengage Learning; 2010. …

Genetically predicted immune cells and metabolites mediate the causal relationship between inflammatory factors and rheumatoid arthritis.

This study investigates the causal relationship between inflammatory factors and rheumatoid arthritis (RA) and potential immune cells and metabolites mediator using Mendelian randomization. A bidirectional Mendelian randomization study was conducted using statistics from a genome-wide association study database to explore the causal relationship between inflammatory factors and RA, combined with mediation analysis, to discover potential immune cells and metabolites with mediating effects, and to estimate the proportion of total effects mediated by each immune cell and metabolite. The level of

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… Biostatistics. 2021;22:68–81. [24] Wang X, Wang X, Gong Y, et al. Appraising the causal association between systemic iron status and heart failure risk: a mendelian randomisation study. Nutrients. 2022;14:3258. [25] Hemani G, Zheng J, Elsworth B, et al. …

Society for Immunotherapy of Cancer clinical and biomarkers data sharing resource document: Volume I-conceptual challenges.

The sharing of clinical trial data and biomarker data sets among the scientific community, whether the data originates from pharmaceutical companies or academic institutions, is of critical importance to enable the development of new and improved cancer immunotherapy modalities. Through data sharing, a better understanding of current therapies in terms of their efficacy, safety and biomarker data profiles can be achieved. However, the sharing of these data sets involves a number of stakeholder groups including patients, researchers, private industry, scientific journals and professional societ

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… the National Institutes of Health (FNIH) has launched and coordinated the Partnership for Accelerating Cancer Therapies (PACT) program, aimed at building an oncology clinical study database with state-of-the art study design, technology implementation, and pipelines for databases, bioinformatics, and biostatistics …

Efficacy of phosphodiesterase type 5 inhibitors in univentricular congenital heart disease: the SV-INHIBITION study design.

AIMS: In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance. However, the level of evidence for the use of PDE5 inhibitors in patients with a single ventricle (SV) remains limited. We present the SV-INHIBITION study rationale, design, and methods. METHODS AND RESULTS: The SV-INHIBITION trial is a nationwide multicentre, randomized, double blind, placebo-controlled, Phase III study, aiming to evaluate the efficacy of sildenafil on the ventilatory efficiency during exercise, in

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… Damien Bonnet, MD, PhD d ; Sebastien Hascoet, MD k a Paediatric and Congenital Cardiology Department, M3C Regional Reference CHD Centre, CHU Montpellier, Montpellier, France b PhyMedExp, CNRS, INSERM, University of Montpellier, CHU Montpellier, Montpellier, France c Department of Epidemiology and Biostatistics …

Clinical Genetics of Cancer 2017 : Szczecin, Poland. 21-22 September 2017

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… Olavs Hospital, Trondheim, Norway; 4 Centre for Clinical Epidemiology and Biostatistics, University of Newcastle, Newcastle, NSW, Australia; 5 School of Biomedical Science and Pharmacy, Faculty of Health and Medicine, University of Newcastle and Hunter Medical Research Institute, Newcastle, Australia …

Plerixafor (a CXCR4 antagonist) following myeloablative allogeneic hematopoietic stem cell transplantation enhances hematopoietic recovery.

BackgroundThe binding of CXCR4 with its ligand (stromal-derived factor-1) maintains hematopoietic stem/progenitor cells (HSPCs) in a quiescent state. We hypothesized that blocking CXCR4/SDF-1 interaction after hematopoietic stem cell transplantation (HSCT) promotes hematopoiesis by inducing HSC proliferation.MethodsWe conducted a phase I/II trial of plerixafor on hematopoietic cell recovery following myeloablative allogeneic HSCT. Patients with hematologic malignancies receiving myeloablative conditioning were enrolled. Plerixafor 240 μg/kg was administered subcutaneously every other day begin

Food and Drug Administration (FDA) Approvals of Biological Drugs in 2023.

An increase in total drug (small molecules and biologics) approvals by the Food and Drug Administration (FDA) was seen in 2023 compared with the previous year. Cancer remained the disease most targeted by monoclonal antibodies (mAbs), followed by autoimmune conditions. Our data reveal the prevalence of approvals for biologics even during years when the total number of authorizations was low, such as in 2022. Over half the drugs that received the green light in 2023 benefited from expedited programs, as the incidence of many diseases increased. In addition, over half of the biologics approved r

The Impact of Survival Benefit and Study Design on FDA Approval for Anticancer Drugs Over the Past Decades.

Despite the tremendous effort in the oncology community, the success rate of anticancer development remained low at 30% to 40% from the Phase 3 study to the regulatory approval. The factors associated with the regulatory approval for market authorization have gained interest in the community to improve the success rate of drug development. Using the data from 208 Phase 3 studies for anticancer drugs, we explored the possible factors associated with the US Food and Drug Administration's (FDA's) approval by multivariate logistic regression analysis. The model incorporated 21 factors from therape

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… Biostatistics. 2019;20:273‐286. 4. Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J. Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32:40‐51. 5. Thomas DV, Burns J, Audette J, et al. Clinical Development Success Rates 2006–2015. …

A liberalized diet does not improve caloric intake during neutropenia in patients undergoing hematopoietic stem cell transplants: A prospective randomized controlled trial.

BackgroundThe neutropenic diet has been a long-standing approach to preventing infection in patients with hematopoietic stem cell transplants (HSCTs), although data on its efficacy are inconclusive and its restrictive nature might contribute to harm by reducing dietary intake in this patient population who typically experiences poor oral intake. The aim was to determine if a liberalized diet (LD), in comparison with a neutropenic hospital diet (ND), would improve energy intake and lessen weight loss during neutropenia in patients with HSCTs.MethodsA randomized controlled trial was conducted in

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… We thank Derek Li, Biostatistics and Computational Biology Shared Resource at the University of Florida Health Cancer Center, for his assistance with data management. …

Clinical impact of clonal hematopoiesis in hematopoietic cell transplantation: a review, meta-analysis, and call to action.

Hematopoietic cell transplantation (HCT) is the only potentially curative treatment option for many patients with hematologic malignancies. While HCT outcomes have improved drastically over the years, patients and clinicians continue to face numerous survivorship challenges, such as relapse, graft-versus-host disease, and secondary malignancies. Recent literature suggests that clonal hematopoiesis (CH), the presence of a recurrent somatic mutation in hematopoietic cells, in HCT patients or donors may be associated with outcomes in autologous and allogeneic HCT. Herein, we perform a review of t

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… Supplementary Material Funding Statement Funding : This work has been supported in part by the Biostatistics and Bioinformatics Shared Resource at the H. Lee Moffitt Cancer Center & Research Institute, an NCI designated Comprehensive Cancer Center (P30-CA076292). …