599 results match your criteria: "Institute of Clinical Pharmacology and Toxicology[Affiliation]"

Risk of congenital malformations and miscarriages following maternal use of oral fluconazole during the first trimester of pregnancy: a systematic review and meta-analysis.

Eur J Epidemiol

December 2024

Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Equipe PEPITES, AP-HP, Hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT), F75012, Paris, France.

The risks related to fluconazole use during the first trimester of pregnancy (T1) remain controversial. The aims of this systematic review and meta-analysis were to assess the association between oral fluconazole during T1 and major congenital malformations (MCM) overall and by subtype, minor malformations and miscarriages.We searched MEDLINE, EMBASE, Cochrane, ICTRP and ClinicalTrials.

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Prostate cancer is the second most commonly diagnosed cancer in men worldwide. Despite this, current diagnostic tools are still not satisfactory, lacking sensitivity for early-stage or single-cell diagnosis. This study describes the development of small-molecule tracers for the well-known tumor marker prostate-specific membrane antigen (PSMA).

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Viral infections can lead to platelet activation and hemostatic complications. However, the extent to which platelet reactivity remains altered after convalescence, contributing to long-term health impairments as observed after COVID-19 is not yet fully understood. Therefore, we conducted a cohort study (DRKS00025217) to determine platelet function in individuals convalesced from mild COVID-19.

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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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Background: Bleeding complications following intramuscular (IM) injections are generally considered rare with reported incidence of 0.06%. However, evidence on safety of IM injections among anticoagulated hospitalized patients is lacking.

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Article Synopsis
  • The study aims to determine the effectiveness of the new-user design in pharmacoepidemiological research by examining the interaction between sulfonylureas and warfarin and its impact on severe hypoglycemia.
  • Researchers analyzed data from patients in the UK's Clinical Practice Research Datalink between 1998 and 2020, matching patients using both medications with those using sulfonylureas alone.
  • Results indicated no significant increase in the risk of severe hypoglycemia for patients taking both sulfonylureas and warfarin, suggesting that the new-user design is a viable method for studying drug-drug interactions.
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Objectives: To assess the efficacy and safety of a two-drug regimen (2DR) with dolutegravir (DTG) and lamivudine (3TC) in maintaining viral suppression during pregnancy and breastfeeding, and to evaluate its potential as an alternative to the recommended three-drug regimen (3DR) in preventing mother-to-child transmission (MTCT) of HIV.

Methods: We present a case of a 34-year-old pregnant woman who, after discontinuing 3DR due to side effects and poor adherence, was switched to DTG/3TC at gestational week 23. Maternal viral load (VL) and infant HIV status were monitored throughout pregnancy and a ten-month breastfeeding period.

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The impact of the COVID-19 Pandemic on hypertension phenotypes (ESH ABPM COVID-19 study).

Eur J Intern Med

September 2024

Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology, Berlin, Germany.

Article Synopsis
  • * It compared two groups of patients with treated hypertension: one group monitored during the pandemic and another monitored before it, looking at changes in hypertension phenotypes like sustained uncontrolled hypertension (SUCH) and sustained controlled hypertension (SCH).
  • * Results showed no significant changes in the pandemic group’s hypertension phenotypes, while the pre-pandemic group saw an increase in SCH and a decrease in SUCH, suggesting the pandemic negatively impacted blood pressure management.
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Comparative risk of infection of medications used for type 2 diabetes.

Expert Opin Drug Saf

September 2024

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.

Introduction: Glucose-lowering drugs pose a potential infection risk among individuals with type 2 diabetes. The U.S.

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Article Synopsis
  • The study investigated how the COVID-19 pandemic affected blood pressure control in patients with hypertension using ambulatory blood pressure monitoring (ABPM).
  • Data were compared between two groups: patients measured before the pandemic and those measured during it, with a total of 704 pandemic patients and 916 prepandemic patients included in the analysis.
  • Results showed that during the pandemic, patients had higher blood pressure readings and a greater prevalence of uncontrolled hypertension, highlighting the need for strategies to manage blood pressure during such crises.
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Article Synopsis
  • - Chronic pain is a significant issue for aging populations, and in Berlin, a study found that 92% of older adults (65+) with care needs utilize nonpharmacological interventions (NPIs) for pain management, favoring active approaches over passive ones.
  • - The study, which included 250 participants, highlighted that 85.6% used active NPIs, especially active movement, with distraction and physiotherapy being the most common methods employed.
  • - Findings revealed a social gradient in NPI usage; those with higher education were three times more likely to use physiotherapy compared to those with lower education, who preferred thermotherapy/compresses instead.
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Background: Atrial fibrillation (AF) is a stroke risk factor that often remains undetected at hospital admission. Long-term Holter monitoring helps to identify patients with previously unrecognized AF. Asymmetric (ADMA) and symmetric dimethylarginine (SDMA) are elevated in AF in cross-sectional studies.

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Opioid Use and the Risk of Ventricular Arrhythmias: A Systematic Review and Meta-Analysis.

Pharmacoepidemiol Drug Saf

August 2024

Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada.

Background: The association between opioid use and the risk of ventricular arrhythmias (VA) is poorly understood.

Aims: The objective of this study was to synthesize the evidence on the risk of VA associated with opioid use.

Materials & Methods: We systematically searched the Cochrane Library, Embase, MEDLINE, and CINAHL databases in July 2022.

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Article Synopsis
  • HFpEF (heart failure with preserved ejection fraction) is linked to inflammation, obesity, and changes in gut microbiome, with high TMAO levels indicating worse outcomes.
  • A study of healthy and obese rats confirmed HFpEF via various measurements, revealing increased TMAO, carnitine, and NT-proBNP levels in obese rats.
  • The impaired intestinal barrier function and decreased FMO3 levels in these rats suggest a connection between microbiome alterations and HFpEF progression, despite stable kidney function.
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Fluoroquinolones and the risk for incidental seizures: a comparative retrospective study.

J Antimicrob Chemother

October 2024

Institute of Clinical Pharmacology and Toxicology, Sheba Medical Center, Tel Hashomer, Israel.

Background: Over the years, reports have associated fluoroquinolones (FQ) with seizures. The incidence and whether FQ compared to non-epileptogenic antibiotic are associated with increased risk of seizures has yet to be examined.

Methods: A retrospective observational study of hospitalized patients treated with FQ (ofloxacin, ciprofloxacin, levofloxacin, moxifloxacin) or macrolides (MA: azithromycin or roxithromycin) between January 2009 and January 2021 in a large tertiary academic medical centre.

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Objective: To evaluate the efficacy and safety of 2 doses of vilaprisan vs. placebo in participants with symptomatic endometriosis.

Design: Multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2b trial (NCT03573336).

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Mortality of patients hospitalized with COVID-19 has remained high during the consecutive SARS-CoV-2 pandemic waves. Early discrimination of patients at high mortality risk is crucial for optimal patient care. Symmetric (SDMA) and asymmetric dimethylarginine (ADMA) have been proposed as possible biomarkers to improve risk prediction of COVID-19 patients.

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Background: Treatment with vitamin K antagonists (VKAs) has been linked to worsening of kidney function in patients with atrial fibrillation (AF).

Objectives: XARENO (Factor XA-inhibition in RENal patients with non-valvular atrial fibrillation Observational registry; NCT02663076) is a prospective observational study comparing adverse kidney outcomes in patients with AF and advanced chronic kidney disease receiving rivaroxaban or VKA.

Methods: Patients with AF and an estimated glomerular filtration rate (eGFR) of 15 to 49 mL/min/1.

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Classic psychedelics and MDMA have a colorful history of recreational use, and both have recently been re-evaluated as tools for the treatment of psychiatric disorders. Several studies have been carried out to assess potential long-term effects of a regular use on cognition, delivering distinct results for psychedelics and MDMA. However, to date knowledge is scarce on cognitive performance during acute effects of those substances.

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Objective Real-life management of patients with hypertension and chronic kidney disease (CKD) among European Society of Hypertension Excellence Centres (ESH-ECs) is unclear : we aimed to investigate it. Methods A survey was conducted in 2023. The questionnaire contained 64 questions asking ESH-ECs representatives to estimate how patients with CKD are managed.

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The search for 3R-relevant information is a prerequisite for any planned experimental approach considering animal use. Such a literature search includes all methods to replace, reduce and refine (3Rs) animal testing with the aim of improving animal welfare, and requires an intensive screening of literature databases reflecting the current state of knowledge in experimental biomedicine. We developed SMAFIRA, a freely available online tool to facilitate the screening of PubMed/MEDLINE for possible alternatives to animal testing.

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Background: Chronic obstructive lung disease (COPD) has diverse molecular pathomechanisms and clinical courses which, however, are not fully mirrored by current therapy. Intermittent hypoxemia is a driver of lung function decline and poor outcome, e.g.

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