634 results match your criteria: "Institute of Biometry and Clinical Epidemiology[Affiliation]"

Background: Deficits in cholinergic function are assumed to cause cognitive decline. Studies have demonstrated that changes in serum cholinesterase activities are associated with a higher incidence of delirium in critically ill patients. Additionally, basic research indicates that the cholinergic and circadian systems are interconnected, with each system influencing the functionality of the other.

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Cancer survivors (CS) often experience treatment-related side effects, such as fatigue, and have reduced physical function. Regular physical activity has been demonstrated to reduce these symptoms and improve cardiopulmonary fitness. Digital solutions are needed to optimize exercise options for CS in aftercare, especially given the significant limitations during the Covid-19 pandemic.

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iKNOW-Supporting the counseling of women with hereditary risk of breast and ovarian cancer with digital technologies: A randomized controlled trial.

Genet Med Open

September 2024

Gender in Medicine, Charité-Universitätsmedizin Berlin, Germany Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.

Purpose: We developed the online-based counseling tool iKNOW for women with a pathogenic germline variant in to improve risk understanding and quality of life.

Methods: With a randomized controlled trial, we investigated the efficacy of iKNOW with regard to risk understanding (primary endpoint), quality of life, risk perception, and anxiety (secondary endpoints). Self-report questionnaires were administered to  = 217 women with a pathogenic variant in before counseling (T0), immediately after (T1), 4 weeks after (T2), and 6 months after (T3).

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Background: Cognitive and neuropsychiatric impairment, known as cerebellar cognitive affective syndrome (CCAS), may be present in cerebellar disorders. This study identified distinct CCAS subtypes in cerebellar patients using cluster analysis.

Methods: The German CCAS-Scale (G-CCAS-S), a brief screening test for CCAS, was assessed in 205 cerebellar patients and 200 healthy controls.

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Background: Intraoperative hypotension is associated with acute kidney injury (AKI). Clinicians thus frequently use vasopressors, such as norepinephrine, to maintain blood pressure. However, vasopressors themselves might promote AKI.

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Importance: The magnetic resonance imaging (MRI) pathway for diagnosing clinically significant prostate cancer (csPCa; defined as International Society of Urological Pathology grade group ≥2) uses multiparametric MRI (mpMRI) for prostate biopsy (PB) decision-making. However, the intermediate impact on patient outcomes in men with negative MRI results avoiding PB and men with positive MRI results without PCa remains unknown.

Objective: To assess the feasibility and safety of a community-based MRI diagnostic strategy in men with suspected PCa using 3-year active monitoring.

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The combined assessment of p16 and Mib/Ki-67 in oral squamous cell carcinoma.

Front Oncol

November 2024

Department of Oral and Maxillofacial Surgery, Fachklinik Hornheide, Münster, Germany.

Objective: Despite numerous studies addressing the impact of p16 in oral squamous cell carcinoma (OSCC), consistent data regarding survival and tumor proliferation behavior are lacking. Although some authors investigate both p16 and Mib/Ki-67 in their cohorts, direct correlations are consistently missing. The aim of this study was to investigate the combined influence of p16 and Mib/Ki-67 status on prognosis in OSCC.

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Unlabelled: Stroke frequently results in mobility impairments, contributing to an increased cardiovascular risk. Despite efforts to promote physical activity, stroke survivors fail to meet recommended levels. This secondary analysis of the 'Physical Fitness in Patients with Subacute Stroke' (Phys-Stroke) trial analyzes physical activity at 6 months post-stroke, and examines the effect of gains in walking capacity during the subacute phase on physical activity in the chronic stage.

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Objectives: To examine the relationship between the quality of paraspinal muscles and pain intensity, duration, and quality of life in patients with chronic low back pain (cLBP).

Methods: Between January 2022 and December 2023, 119 individuals with no-back pain (no-BP) and 136 cLBP patients were enrolled. Both groups underwent health surveys and magnetic resonance imaging.

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Hospital-Acquired Pressure Ulcers and Long-Term Motor Score Recovery in Patients With Acute Cervical Spinal Cord Injury.

JAMA Netw Open

December 2024

Department of Neurology and Experimental Neurology, Clinical and Experimental Spinal Cord Injury Research (Neuroparaplegiology), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.

Importance: Pressure ulcers (PUs) are (1) prevalent secondary complications after spinal cord injury (SCI), (2) present with elevated systemic inflammatory tone, and (3) may interfere with healing processes underlying neurological recovery (disrepair).

Objective: To investigate whether PUs acquired during initial hospitalization are associated with neurological and functional long-term outcome and survival after SCI.

Design, Setting, And Participants: Multicenter cohort study at 20 centers of the prospective SCI Model Systems (SCIMS) Database (Birmingham, AL).

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Ravulizumab and Efgartigimod in Myasthenia Gravis: A Real-World Study.

Neurol Neuroimmunol Neuroinflamm

January 2025

From the Department of Neurology with Experimental Neurology (F.S., S.L., M.S., M.H., P.D., L.M.G., S.H., A.M.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt Universität zu Berlin; Neuroscience Clinical Research Center (F.S., S.L., M.S., M.H., P.D., L.M.G., S.H., A.M.), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt Universität zu Berlin; Department of Neurology with Institute of Translational Neurology (C.D.F.S., M.B., C.W.K., L.K., H.W., J.D.L.), University Hospital Münster; Institute of Biometry and Clinical Epidemiology (A.A.), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin; Center for Stroke Research Berlin (A.A., M.S., A.M.), Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Germany; Department of Immunology (K.L.), Hellenic Pasteur Institute; and 2nd Neurology Department (J.T.), School of Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Greece.

Background And Objectives: Biologics that target pathogenic antibodies (Abs) and their effector functions such as the complement inhibitor ravulizumab and the neonatal Fc receptor agonist efgartigimod have recently been approved for the treatment of acetylcholine receptor (AChR)-Ab-positive myasthenia gravis (MG), but comparative studies are lacking.

Methods: In a prospective, exploratory real-world study, we assessed clinical efficacy, safety, and biological effects of ravulizumab and efgartigimod treatment initiation. Myasthenia Gravis-Activities of Daily Living and Quantitative Myasthenia Gravis scores were used as clinical endpoints.

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Article Synopsis
  • Hypernatremia is a common and serious condition in ICU patients, linked to higher mortality and longer stays, prompting this study to compare sodium chloride 0.9% and glucose 5% solutions as intravenous drug diluents.
  • The study analyzed 265 adult COVID-19 patients, observing sodium levels and severe hypernatremia over the first 8 days after ICU admission, finding that glucose 5% led to lower sodium levels and reduced occurrences of severe hypernatremia.
  • The results suggest that switching to glucose 5% as the standard diluent can help prevent hypernatremia in ICU patients, indicating a potentially simple change in treatment protocols.
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In many life science experiments or medical studies, subjects are repeatedly observed and measurements are collected in factorial designs with multivariate data. The analysis of such multivariate data is typically based on multivariate analysis of variance (MANOVA) or mixed models, requiring complete data, and certain assumption on the underlying parametric distribution such as continuity or a specific covariance structure, for example, compound symmetry. However, these methods are usually not applicable when discrete data or even ordered categorical data are present.

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Increase in PUFA and protein, and decrease in carbohydrate intake improves liver fat in 12 months and the role of weight loss as a mediator: A randomized controlled trial.

Clin Nutr

December 2024

Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology and Metabolism, 10117, Berlin, Germany; NutriAct-Competence Cluster Nutrition Research Berlin-Potsdam, Germany; German Center for Diabetes Research (DZD e.V.), Neuherberg, Germany; Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charité Center for Cardiovascular Research, 10117, Berlin, Germany; DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Germany; Max Rubner Center for Cardiovascular Metabolic Renal Research, 10115, Berlin, Germany. Electronic address:

Background & Aims: Recently, a beneficial effect of high intake of unsaturated fatty acids (UFA) and protein on intrahepatic lipids (IHL) was demonstrated over 12 months within a randomized controlled trial (the NutriAct trial). We now aimed to explore the specific macronutrient components driving this IHL improvement within this trial in middle-aged and elderly subjects (50-80 y) at risk for age-related diseases.

Methods: The NutriAct trial (n = 502) analyzed the effect of a high-protein and high-UFA diet on age related diseases including fatty liver disease.

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Long-term effects of tocilizumab on retinal and choroidal inflammation in Birdshot uveitis.

J Ophthalmic Inflamm Infect

November 2024

Department of Ophthalmology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.

Article Synopsis
  • Tocilizumab (TCZ) is a drug used for rheumatic diseases that has shown promise in treating refractory non-infectious uveitis (NIU), particularly in Birdshot NIU, and this study examined its long-term effects.
  • Eight patients were monitored over an average of 33 months using various imaging techniques to assess retinal and choroidal inflammation, with significant improvements noted in retinal inflammation and central retinal thickness (CRT) after six months.
  • While TCZ effectively reduced retinal vasculitis and improved CRT, it was less effective for choroidal inflammation, indicating a need for further research to optimize TCZ treatment in NIU patients.
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Background: Associations between longitudinal changes of plasma biomarkers and cerebral magnetic resonance (MR)-derived measurements in Alzheimer's disease (AD) remain unclear.

Methods: In a study population (n = 127) of healthy older adults and patients within the AD continuum, we examined associations between longitudinal plasma amyloid beta 42/40 ratio, tau phosphorylated at threonine 181 (p-tau181), glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL), and 7T structural and functional MR imaging and spectroscopy using linear mixed models.

Results: Increases in both p-tau181 and GFAP showed the strongest associations to 7T MR-derived measurements, particularly with decreasing parietal cortical thickness, decreasing connectivity of the salience network, and increasing neuroinflammation as determined by MR spectroscopy (MRS) myo-inositol.

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Leveraging large language models to construct feedback from medical multiple-choice Questions.

Sci Rep

November 2024

Data-Intensive Systems and Visualization Group (dAI.SY), Fakultät für Informatik und Automatisierung, Technische Universität Ilmenau, Ehrenbergstraße 29, 98693, Ilmenau, Thuringia, Germany.

Exams like the formative Progress Test Medizin can enhance their effectiveness by offering feedback beyond numerical scores. Content-based feedback, which encompasses relevant information from exam questions, can be valuable for students by offering them insight into their performance on the current exam, as well as serving as study aids and tools for revision. Our goal was to utilize Large Language Models (LLMs) in preparing content-based feedback for the Progress Test Medizin and evaluate their effectiveness in this task.

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In many trials and experiments, subjects are not only observed once but multiple times, resulting in a cluster of possibly correlated observations (e.g., brain regions per patient).

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Aims: Timely referrals for transplantation and left ventricular assist device (LVAD) play a key role in favourable outcomes in patients with advanced heart failure (HF). Cardiovascular mortality, driven by sudden cardiac death, is the main reason for dying while waiting for heart transplantation (HTx). The purpose of the Preventive Catheter Ablation for ventricular arrhythmiaS in patients with end-sTage heart faiLure rEferred for heart transplantation eValuaTion (CASTLE-VT) trial is to test the hypothesis that prophylactic catheter ablation of arrhythmogenic ventricular scar tissue will reduce mortality, need for LVAD implantation, and urgent HTx in patients with end-stage HF related to ischaemic cardiomyopathy (ICM).

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Background: COVID-19 vaccines are well tolerated and effective but may have adverse effects on the cardiovascular system. Vaccine-associated myocardial injury was analysed by measuring high-sensitive troponin T (hsTnT); mid-regional pro-adrenomedullin (MR-proADM) levels were evaluated to assess endothelial dysfunction.

Methods: This was a prospective study with a vulnerable population of healthcare workers (HCWs) and elderly patients (>70 years) who were vaccinated with either one dose of ChAdOx1 nCov-19 adenoviral vector vaccine (AZ) followed by one dose of the BNT162b2 messenger RNA vaccine (BNT), or with two doses of BNT (12th of January - 30th of November 2021).

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Article Synopsis
  • Patients who have suffered a stroke are at higher risk for developing post-stroke dementia, and the presence of serum anti-NMDA receptor autoantibodies (NMDAR1-abs) may negatively impact cognitive outcomes, particularly memory.
  • In a study using the DEMDAS cohort, researchers found that 10.2% of stroke patients were seropositive for NMDAR1-abs, but this did not correlate with overall cognitive decline.
  • However, those with NMDAR1-abs did show significantly worse performance in memory tasks and were more likely to experience memory impairment one year post-stroke, indicating a specific link between these autoantibodies and memory dysfunction.
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Landmarking for Left-Truncated Competing Risk Data.

Biom J

December 2024

Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charitéplatz 1, Berlin, Germany.

Landmarking is an alternative to complex multistate models when the aim is to calculate dynamic predictions. We develop the concept of landmarking for the case of left truncation and competing risks from the application background of drug safety assessment in pregnancy. The method is illustrated with a cohort study of the German Embryotox Pharmacovigilance Institute in Berlin to assess if the risk or the cumulative incidence of adverse pregnancy outcomes, like spontaneous abortions (SABs), is increased in fluoroquinolone-exposed women.

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Introduction: Wheezing is an important indicator of exacerbated respiratory symptoms in early childhood and must be monitored to regulate pharmacological therapy. However, parents' subjective perception of wheezing in their children is not always precise. We investigated the objective identification of children's wheezing by parents using a digital wheeze detector (WheezeScan, OMRON Healthcare Co.

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Article Synopsis
  • * In a study of 194 patients, those who underwent catheter ablation showed a significant decrease in AF recurrence and improvement in their heart function, with left ventricular ejection fraction (LVEF) rising from 29.2% to 39.1% after 12 months.
  • * Overall, AF ablation not only lowered AF burden but also successfully shifted patients from persistent AF to a less severe form, benefiting those with or without left atrial cardiomyopathy.
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