111,476 results match your criteria: "Clinical Research Biostatistics & Bioinformatics[Affiliation]"

Safety and immunogenicity of an mRNA-1273 vaccine booster in adolescents.

Hum Vaccin Immunother

December 2025

Research and Development, Infectious Disease, Moderna, Inc., Cambridge, MA, USA.

Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12-17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427).

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External Validation of a 5-Factor Risk Model for Breast Cancer-Related Lymphedema.

JAMA Netw Open

January 2025

Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.

Importance: Secondary lymphedema is a common, harmful side effect of breast cancer treatment. Robust risk models that are externally validated are needed to facilitate clinical translation. A published risk model used 5 accessible clinical factors to predict the development of breast cancer-related lymphedema; this model included a patient's mammographic breast density as a novel predictive factor.

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Importance: Spontaneous reports have indicated that montelukast increases the risk of neuropsychiatric adverse events, and the US Food and Drug Administration added a boxed warning about these risks in 2020. However, the potential mechanism is not well understood, and the observational evidence is scarce, particularly in children.

Objective: To assess the potential association between the use of montelukast and the risk of neuropsychiatric adverse events in children and adolescents.

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Aim: Identify values that could predict the presence of increased pressure-pain sensitivity independent of the migraine cycle through a single assessment.

Methods: This was a secondary analysis of a previous study in which 198 episodic and chronic migraine patients were assessed during all phases of the migraine cycle. Pressure pain threshold (PPT) was assessed over the temporalis, cervical spine, hand, and leg.

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An introduction to propensity score analysis in acute care surgery research: Methodology and pitfalls.

J Trauma Acute Care Surg

January 2025

From the Department of Surgery (T.G.) and Department of Biostatistics and Epidemiology (T.G.), University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma; and Comparative Effectiveness and Clinical Outcomes Center (CECORC) (Z.L.B.), Riverside University Health Systems, Moreno Valley, CA.

Observational studies assessing causal effects of interventions are subject to indication (selection) bias, which may be difficult to eliminate using traditional multivariable techniques. When properly specified, propensity score-adjusted analysis may offer an advantage traditional regression by ensuring that investigators explicitly assess comparability of baseline prognostic factors between the treated and untreated. However, it is important to note that the effectiveness of a propensity score-adjusted analysis depends on the variables selected for the model and the analytic approach.

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To estimate time-to-progression milestones in people with amyotrophic lateral sclerosis (PALS) treated versus not treated with intravenous (IV) edaravone (Radicava IV, Mitsubishi Tanabe Pharma America [MTPA], hereafter "IV edaravone") in a real-world setting. IV edaravone is US FDA approved for the treatment of ALS and was shown in clinical trials to slow the rate of physical functional decline. This retrospective observational analysis included PALS continuously enrolled in Optum's Clinformatics Data Mart between 8 August 2017 and 31 December 2021.

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The effect of moderate-late preterm (MLP; 32 to 36 completed weeks' gestation) birth on childhood respiratory health is unclear. To assess the effect of being born MLP, compared with being born at term (≥37 completed weeks' gestation), on lung function and respiratory morbidity at 9-10 years of age. Prospective cohort of children born MLP or at term at the Royal Women's Hospital, Victoria, Australia.

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Objective: Cognitive dysfunction is a significant issue in old age and can cause many problems in older adults, especially those with diabetes. This study aimed to investigate the association between oral health status and DMFT index with cognitive dysfunction in community-dwelling older adults with T2D (type 2 diabetes).

Methods: This was a cross-sectional study that included 245 older people aged 60 years and older with T2D, visiting healthcare centers in north of Iran, using the cluster sampling method.

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The personalized prescription plan (PPP) summarizes the changes made to a patient's prescription on discharge from hospital. The aim of the present study was to evaluate 30-day medication continuity in older patients whose PPP was implemented at hospital discharge. Prospective randomized controlled trial including people aged at least 75 discharged from an acute geriatric unit.

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Effect of a Medication Adherence Education Intervention on Clinical Outcomes in Adults with Type 2 Diabetes Mellitus: A Randomized Controlled Trial Study.

Endocr Metab Immune Disord Drug Targets

January 2025

Mohammad Asghari Jafarabadi: Professor of Biostatistics, Cabrini Research, Cabrini Health, VIC 3144, Australia; School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, VIC 3800, Australia; Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Background: Low adherence to Oral Antidiabetic Drugs (OADs) in adults with Type 2 Diabetes Mellitus (T2DM) leads to complications, death, and increased healthcare costs.

Objective: This study aimed to evaluate the effectiveness of medication adherence education interventions for the clinical outcomes of adults with T2DM.

Materials And Methods: Seventy adults with T2DM from an outpatient clinic in the City of Ardabil, Iran, participated in this study.

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Education Research: Making a Tweetorial Fly: Features of Educational Social Media Posts Associated With High Sharing and Engagement.

Neurol Educ

December 2024

From the Departments of Neurology and Neurosurgery (C.S.W.A., E.C.L.), Emory University School of Medicine, Atlanta, GA; Division of Biostatistics (T.M.), Rollins School of Public Health, Emory University, Atlanta, GA; Department of Neurology (G.F.P.), University of Pittsburgh, PA; Department of Neurology (A.S.Z.), Weill Cornell Medical College, New York, NY; Emory University School of Medicine (N.D.), Atlanta, GA; Consulting Web Developer (S.M.), Scotland; Department of Neurology (A.S.), Wake Forest University, Winston-Salem, NC; Departments of Neurology and Neurosurgery (N.S.D), Icahn School of Medicine at Mount Sinai, New York, NY; Department of Neurology (A.L.B.), University of California, San Francisco; Department of Neurology (N.A.M.), University of Maryland School of Medicine, Baltimore, MD; and Department of Neurology (L.K.J.), Mayo Clinic, Rochester, MN.

Background And Objectives: Social media platforms such as X (formerly Twitter) are increasingly used in medical education. Characteristics of tweetorials (threaded teaching posts) associated with higher degrees of engagement are unknown. We sought to understand features of neurology-themed tweetorials associated with high sharing and engagement.

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Background: People with diabetes are at increased risk of hospitalisation, morbidity, and mortality following SARS-CoV-2 infection. Long-term outcomes for people with diabetes previously hospitalised with COVID-19 are, however, unknown. This study aimed to determine the longer-term physical and mental health effects of COVID-19 in people with and without diabetes.

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Unlabelled: In this unblinded multi-center stepped-wedge randomized controlled trial the effectiveness of the nurse-led ZENN-intervention was tested in promoting self-management skills in comparison to standard care among heart, lung and kidney transplant recipients. This intervention is based on behaviour change theories and was conducted in four sessions over 6 months at the outpatient clinic. The experimental group received standard care, plus the ZENN-intervention, while the control group received only standard care.

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This study investigates the association between self-reported birth weight (BW) and the frequency of cataract and pseudophakia in a large population-based cohort in Germany, as part of the Gutenberg Health Study (GHS). Slit lamp examination and Scheimpflug imaging of 8205 participants, aged 35 to 74, were assessed and signs of cataract or pseudophakia analyzed. The research aimed to explore the correlation between fetal growth restriction and/or prematurity indicated by BW and the frequency of cataract and pseudophakia.

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Background: In the DISCOMS (DISCOntinuation of disease-modifying therapies (DMTs) in multiple sclerosis (MS)) randomized clinical trial, we could not demonstrate that discontinuing MS DMTs in older, stable adults was not inferior to continuing DMTs. Relapses were rare in both groups, and most new disease activity was one to two new brain magnetic resonance imaging (MRI) lesions unassociated with clinical changes.

Objective/aims: Describe results of the DISCOMS extension study.

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Introduction: Societal stressors place a tremendous burden on individuals who identify with a sexual minority identity. While minority stress experienced by racial/ethnic minority groups has been linked to accelerated aging, this link has yet to be examined among sexual minority youth. This study explores whether sexual minority youth who indicate experiencing stress at home or school (Minority Stress) due to their identity show evidence of accelerated aging (pubertal status or tempo) compared to those who do not report such experiences (No Minority Stress).

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Strontium-90 plesiotherapy delivers high doses of radiation to superficial lesions (<3 mm depth) with excellent sparing of deeper tissues. The sealed-source applicator tip is circular and 8-10 mm in diameter. Larger treatment fields are treated with multiple overlapping fields.

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Advanced glycation end products and breast cancer risk in a sample of the ORDET cohort.

Int J Biol Markers

January 2025

Epidemiology and Prevention Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.

Introduction: Breast cancer is the most common cancer among women, and metabolic syndrome (MetS) is a risk factor for breast cancer, especially postmenopausal breast cancer. We evaluated the role of the advanced glycated end products (AGEs) levels contributing to the association between MetS and breast cancer risk.

Methods: Plasma AGEs were measured in a case-control study nested within the Hormones and Diet in the Etiology of Breast Tumors (ORDET) cohort, including 40 incident postmenopausal breast cancer cases (20 with MetS and 20 without) and 40 postmenopausal controls (20 with MetS and 20 without).

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 Cognitive impairment is a core feature of traumatic encephalopathy syndrome (TES), the putative clinical syndrome of chronic traumatic encephalopathy-a neuropathological disease associated with repetitive head impacts (RHI). Careful operationalization of cognitive impairment is essential to improving the diagnostic specificity and accuracy of TES criteria. We compared single- versus two-test criteria for cognitive impairment in their associations with CSF and imaging biomarkers in male former American football players.

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Background: Despite efforts to promote optimal breastfeeding practices, the practice of exclusive breastfeeding is low in South Africa. We conducted a trial to determine whether text messaging plus motivational interviewing prolonged exclusive breastfeeding during the first six months of life and improved child health outcomes.

Methods: We conducted a randomized parallel group-controlled trial between July 2022 and May 2024, at a secondary-level healthcare facility.

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Kidney failure-related excess mortality during the first three years of the COVID-19 pandemic in the United States: a nation-wide, population-based analysis.

BMC Public Health

January 2025

Department of Pulmonary and Critical Care Medicine, Zhujiang Hospital, Southern Medical University, No.253 Industrial Avenue Middle, Guangzhou, 510280, China.

Background: The onset of the COVID-19 pandemic has had a detrimental impact on the healthcare system. Patients with kidney failure and related kidney disease are notably vulnerable to the COVID-19 pandemic. However, it remains unclear how mortality trends associated with kidney failure have evolved over the past three years.

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Background: The coexistence of obesity and hypertension (HTN) is a global health concern due to its association with various health abnormalities. This study targeted the association between uncontrolled HTN-defined according to the JNC8 guidelines- and different obesity patterns (general and abdominal) among adult hypertensive individuals.

Methods: Data for the present investigation were obtained from the 2021 STEPwise Approach to NCD Risk Factor Surveillance (STEPS) national survey in Iran.

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Intensified Induction Therapy for Newly Diagnosed, Localized Skeletal Ewing Sarcoma (ISG/AIEOP EW-1): A Randomized, Open-Label, Phase 3, Non-Inferiority Trial.

Pediatr Blood Cancer

January 2025

Osteoncology, Bone and Soft Tissue Sarcomas and Innovative Therapies Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.

Background: Several studies have shown that the intensity of treatment in Ewing sarcoma has an impact on outcome. The present trial tested the non-inferiority of intensive, shorter, induction chemotherapy (25 weeks total treatment time) compared to the standard treatment (37 weeks) in non-metastatic Ewing sarcoma (ES) at onset.

Procedure: This national, multicenter, parallel, randomized, controlled, open-label, non-inferiority, phase III trial was conducted in 14 specialized hospitals in Italy.

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Background: A substantial subset of individuals recovering from the Coronavirus disease 2019 (COVID-19) continues to experience persistent symptoms. Individuals with type 2 diabetes face increased morbidity and mortality following COVID-19 infection. This study aimed to identify risk factors for developing post-COVID-19 conditions among COVID-19 patients with diabetes compared to those without diabetes in the United Arab Emirates.

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