6,780 results match your criteria: "Alliance Clinical Trials & Probity Medical Research[Affiliation]"

Following a decades-long decline in psychedelic research resulting from social, political, and legislative factors, there has been greatly renewed interest in these compounds' ability to treat psychiatric disorders. Classic psychedelics, encompassing both natural and synthetic psychoactive compounds, are characterized by their action as agonists or partial agonists of serotonin 5-hydroxytryptamine 2A receptors. In this comprehensive review, we summarize the latest clinical trials of classic psychedelics on depression and anxiety, attending to the patient demographics and methodology of each study.

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Background: (pneumococcus) causes invasive pneumococcal disease (IPD) and non-invasive acute respiratory infections (ARIs). Three pneumococcal conjugate vaccines (PCVs) are recommended in the United States with additional products in clinical trials. We aimed to estimate 1) proportions of IPD cases and pneumococcal ARIs caused by serotypes targeted by existing and pipeline PCVs and 2) annual U.

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Aims: The majority of studies of mental health interventions for young adolescents have only evaluated short-term benefits. This study evaluated the longer-term effectiveness of a non-specialist delivered group-based intervention (Early Adolescent Skills for Emotions; EASE) to improve young adolescents' mental health.

Methods: In this single-blind, parallel, controlled trial, Syrian refugees aged 10-14 years in Jordan who screened positive for psychological distress were randomised to receive either EASE or enhanced usual care (EUC).

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The disadvantaged populations eGFR (estimated glomerular filtration rate) epidemiology (DEGREE) study was designed to gain insight into the burden of chronic kidney disease (CKD) of undetermined cause (CKDu) using standard protocols to estimate the general-population prevalence of low eGFR internationally. Therefore, we estimated the age-standardized prevalence of eGFR under 60 ml/min per 1.73m in adults aged 18-60, excluding participants with commonly known causes of CKD; an ACR (albumin/creatinine ratio) over 300 mg/g or equivalent, or self-reported or measured (HT) hypertension or (DM) diabetes mellitus, stratified by sex and location.

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Allogeneic umbilical cord-derived mesenchymal stromal cells as treatment for systemic lupus erythematosus: a single-centre, open-label, dose-escalation, phase 1 study.

Lancet Rheumatol

December 2024

SITI, CHU Rennes, Etablissement Français du Sang Bretagne, Rennes, France; INSERM UMR 1236, Université Rennes, INSERM, Etablissement Français du Sang Bretagne, Rennes, France. Electronic address:

Background: Patients with systemic lupus erythematosus (SLE) with inadequate responses to standard therapies have unmet therapeutic needs. The immunomodulatory, proangiogenic, and antifibrotic properties of mesenchymal stromal cells support their use in treating patients with SLE. We aimed to assess the safety of a single intravenous infusion of allogeneic umbilical cord-derived mesenchymal stromal cells in patients with severe SLE.

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The healthcare system in the United States (US) is complex and often fragmented across national and regional health plans which exhibit substantial variability in benefit design and formulary policies for accessing medications. We propose an access-focused value assessment framework for formulary decision-making for medications to manage immune-mediated inflammatory diseases (IMIDs), where patients are at the center of this framework. Formulary decision-making for IMID medications can be a challenging, even daunting, task with continuously evolving and enhanced treat-to-target goals.

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Investigating the complementary value of OCT to MRI in cognitive impairment in relapsing-remitting multiple sclerosis.

Mult Scler

December 2024

Queen Square MS Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK.

Background: Cognitive decline in multiple sclerosis (MS) is associated with neuro-axonal loss, quantifiable by optical coherence tomography (OCT). Associations between OCT measures and cognition in relapsing-remitting MS (RRMS) remain incompletely investigated, particularly the added value of OCT when combined with magnetic resonance imaging (MRI). We investigated the contributions of OCT and MRI while applying stringent criteria to control for subclinical optic neuropathy.

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Background: Although dyslipidemia has been acknowledged as a risk factor for Alzheimer's disease (AD), the effects of lipid-lowering drugs on AD have not been determined. The primary pathophysiological hallmark of AD is the deposition of amyloid-β (Aβ) plaques in the brain. Plasma Aβ levels are influenced by the transport of Aβ from the central nervous system to the peripheral blood.

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Comparative efficacy and acceptability of pharmacological, psychological, and neurostimulatory interventions for ADHD in adults: a systematic review and component network meta-analysis.

Lancet Psychiatry

January 2025

Hampshire and Isle of Wight NHS Foundation Trust, Southampton, UK; Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, University of Southampton, Southampton, UK; Developmental EPI Evidence Synthesis, Prediction, Implementation Lab, Centre for Innovation in Mental Health-School of Psychology, Faculty of Environmental and Life Sciences, University of Southampton, Southampton, UK; New York University Child Study Center, Hassenfeld Children's Hospital at NYU Langone, New York, NY, USA; Department of Precision and Regenerative Medicine and Ionian Area, University of Studies of Bari Aldo Moro, Bari, Italy.

Background: The comparative benefits and harms of available interventions for ADHD in adults remain unclear. We aimed to address these important knowledge gaps.

Methods: In this systematic review and component network meta-analysis (NMA), we searched multiple databases for published and unpublished randomised controlled trials (RCTs) investigating pharmacological and non-pharmacological interventions for ADHD in adults from database inception to Sept 6, 2023.

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Introduction: This research sought to identify trends in the patient with lung cancer (LC) care pathway, experiences, and needs, across geographies and healthcare settings.

Methods: Patients living with LC for more than 18 years in nine countries completed an online survey covering these domains-demographic, disease, treatment, and patient preferences for information and support services. Recruitment was primarily from patient with LC communities on online platforms.

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Background: Traditional randomised controlled trials (RCTs) are the gold standard for evaluating the effectiveness of interventions in clinical research. Traditional RCTs however are complex, expensive and have low external validity. Registry-based randomised controlled trials (RRCTs) are an emerging alternative approach that integrates the internal validity of a traditional RCT with the external validity of a clinical registry by recruiting more real-world patients and leveraging an existing registry platform for data collection.

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Patterns of genomic instability in > 2000 patients with ovarian cancer across six clinical trials evaluating olaparib.

Genome Med

December 2024

Translational Medicine, Oncology R&D, AstraZeneca, Cambridge Biomedical Campus, 1 Francis Crick Avenue, Cambridge, CB2 0AA, UK.

Background: The introduction of poly(ADP-ribose) polymerase (PARP) inhibitors represented a paradigm shift in the treatment of ovarian cancer. Genomic data from patients with high-grade ovarian cancer in six phase II/III trials involving the PARP inhibitor olaparib were analyzed to better understand patterns and potential causes of genomic instability.

Patients And Methods: Homologous recombination deficiency (HRD) was assessed in 2147 tumor samples from SOLO1, PAOLA-1, Study 19, SOLO2, OPINION, and LIGHT using next-generation sequencing technology.

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Objectives: To explore physiotherapists' experiences and perceived acceptability of delivering a bracing intervention for knee osteoarthritis (OA) in the 'PROvision of braces for Patients with knee OA' (PROP OA) randomised controlled trial.

Method: Semi-structured telephone interviews with consenting physiotherapists who received the PROP OA training programme and delivered the knee bracing intervention (advice, information and exercise instruction plus knee brace matched to patients' clinical and radiographic presentation and with adherence support). Interviews were recorded and transcribed verbatim.

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Article Synopsis
  • Congenital heart disease (CHD) significantly increases the risk of thromboembolism (TE) in children, with a study finding that 33% of affected patients experienced recurrent TE within a year.
  • Among the risk factors identified, immobility and the presence of central venous catheters (CVC) were strongly associated with a higher likelihood of recurrence, demonstrating the need for careful monitoring and management in this population.
  • The study calls for larger multicenter research to further validate these findings and improve understanding of TE recurrence in pediatric patients with CHD.
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Article Synopsis
  • Phenylketonuria (PKU) is a metabolic disorder that leads to high levels of phenylalanine, affecting speech and cognitive function.
  • Researchers used the Cookie Theft Picture Task to analyze spontaneous speech from adults with PKU and found significant linguistic differences compared to those without the disorder, despite traditional tests showing no differences.
  • Advanced AI analysis identified a new dimension of verbal proficiency correlated with PKU biomarkers, suggesting potential for improved assessments in PKU and other rare diseases through speech analysis.
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Article Synopsis
  • Schnitzler syndrome is an adult-onset autoinflammatory condition presenting with a rash, fever, and fatigue, but lacks an approved treatment, prompting this study on canakinumab.
  • In this phase II trial, five patients received a single dose of canakinumab, with the goal of achieving a complete clinical response (CR) and tracking improvements in quality of life and inflammatory markers.
  • The results indicated that 60% of patients achieved CR by Day 7, and all patients demonstrated improvements in inflammation and quality of life, suggesting canakinumab may be beneficial for those with Schnitzler syndrome.
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Background: The relationship between the extent and severity of stress-induced ischemia and the extent and severity of anatomic coronary artery disease (CAD) in patients with obstructive CAD is multifactorial and includes the intensity of stress achieved, type of testing used, presence and extent of prior infarction, collateral blood flow, plaque characteristics, microvascular disease, coronary vasomotor tone, and genetic factors. Among chronic coronary disease participants with site-determined moderate or severe ischemia, we investigated associations between ischemia severity on stress testing and the extent of CAD on coronary computed tomography angiography.

Methods: Clinically indicated stress testing included nuclear imaging, echocardiography, cardiac magnetic resonance imaging, or nonimaging exercise tolerance test.

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Structured tailored rehabilitation after hip fragility fracture: The 'Stratify' feasibility and pilot randomised controlled trial protocol.

PLoS One

December 2024

Department of Population Health Sciences, School of Life Course and Population Health, Faculty of Life Science and Medicine, King's College London, London, United Kingdom.

Background: Rehabilitation in hospital is effective in reducing mortality after hip fracture. However, there is uncertainty over optimal in-hospital rehabilitation treatment ingredients, and the generalizability of trial findings to subgroups of patients systematically excluded from previous trials. The aim of this study is to determine the feasibility of a randomized controlled trial which aims to assess the clinical- and cost-effectiveness of adding a stratified care intervention to usual care designed to improve outcomes of acute rehabilitation for all older adults after hip fracture.

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Biased Language in Simulated Handoffs and Clinician Recall and Attitudes.

JAMA Netw Open

December 2024

Division of Hospital Medicine, Department of Pediatrics, Duke University, Durham, North Carolina.

Importance: Poor-quality handoffs can lead to medical errors when transitioning patient care. Biased language within handoffs may contribute to errors and lead to disparities in health care delivery.

Objective: To compare clinical information recall accuracy and attitudes toward patients among trainees in paired cases of biased vs neutral language in simulated handoffs.

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The Oral Bioavailability of Vitamin B at Different Doses in Healthy Indian Adults.

Nutrients

November 2024

Division of Nutrition, St. John's Research Institute, St. John's National Academy of Health Sciences, Bangalore 560034, India.

Background/objectives: The bioavailability of crystalline vitamin B (B) through active absorption is reported to have a maximum capacity of 1.5-2.5 µg per dose.

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Background And Objective: We conducted an opportunistic pharmacokinetic study to evaluate the population pharmacokinetics of meropenem, an antimicrobial commonly used to treat Gram-negative infections in adults of different ages, including older adults, and determined optimal dosing regimens.

Methods: A total of 99 patients were included. The population pharmacokinetic models used had two compartments: zero-order input and linear elimination.

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Purpose: To provide evidence-based guidance for clinicians who treat patients with stage I-III anal cancer.

Methods: A systematic review of the literature conducted by the Minnesota Evidence-based Practice Center provided the evidence base for this guideline. An ASCO Expert Panel reviewed this evidence and came to consensus on a set of evidence-based recommendations.

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Background: No models predict future outcomes in inflammatory bowel disease (IBD) patients receiving maintenance infliximab therapy. We created a predictive model for unfavorable outcomes.

Methods: Adult patients with IBD receiving maintenance infliximab therapy at 2 centers with matched serum infliximab concentrations and blinded histologic scores (Robarts Histopathologic Index [RHI]) were included.

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A key lesson from the west Africa (2014-16) Ebola disease epidemic was that outbreak responses fail when they respond to patients through a narrow clinical lens without considering the broader community and social context of care. Here, in the second of two Series papers on the modern landscape of Ebola disease, we review progress made in the last decade to improve patient-centred care. Although the biosafety imperatives of treating Ebola disease remain, recent advances show how to mitigate these so that patients are cared for in a safe and dignified manner that encourages early treatment-seeking behaviour and provides support after the return of patients to their communities.

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Feasibility and safety of autologous cord blood derived cell administration in extremely preterm infants: a single-centre, open-label, single-arm, phase I trial (CORD-SaFe study).

EBioMedicine

January 2025

Monash Newborn, Monash Children's Hospital, Melbourne, Australia; Department of Paediatrics, Monash University, Melbourne, Australia; The Ritchie Centre, Hudson Institute of Medical Research, Melbourne, Australia. Electronic address:

Background: Evidence from preclinical studies in small and large animal models has shown neuroprotective effects of intravenous administration of umbilical cord blood derived cells (UCBCs). This study aimed to evaluate the feasibility of umbilical cord blood (UCB) collection, extraction of UCBCs, and subsequent safety of intravenous autologous administration of UCBCs in extremely preterm infants (born <28 weeks gestation).

Methods: A single-centre, open-label, single-arm, safety and feasibility clinical intervention trial was conducted at Monash Medical Centre and Monash Children's Hospital, Melbourne, Australia.

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