7,031 results match your criteria: "c Medical Services and Clinical Trials; Research and Development[Affiliation]"

Article Synopsis
  • Rheumatoid arthritis (RA) is an autoimmune disease causing chronic inflammation in joints and other organs, leading to potential joint damage and increased health risks if not properly managed.
  • Interleukin-6 (IL-6) is a key cytokine involved in RA, making it a significant target for treatment; therapies like tocilizumab can block IL-6 receptors and help reduce inflammation.
  • Personalizing RA treatment based on individual patient profiles and addressing related health issues can improve outcomes, with a focus on a 'treat-to-profile' strategy that considers the patient's overall health.
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This study aims to determine the bioequivalence of the reference preparation and the test preparation containing eltrombopag when both were given during the COVID-19 pandemic while fasting. Participants in the research were healthy male Caucasian subjects. One film-coated tablet of the test preparation or one film tablet of the reference preparation, equivalent to 75 mg of eltrombopag, was given to the participants in a randomized order throughout each treatment session.

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Observational studies suggest a reduction in fatal or severe COVID-19 disease with the use of ACE2 inhibitors and statins. We implemented a randomized controlled tree-arm open label trial evaluating the benefits of adding telmisartan (TLM) or atorvastatin (ATV) to lopinavir boosted ritonavir (LPVr) on the SARS-CoV-2 nasopharyngeal viral load in patients with mild / moderate COVID-19 infection in Côte d'Ivoire. RT-PCR positive COVID-19 patients ≥ 18 years, with general or respiratory symptoms for less than 7 days were randomized (1:1:1) to receive LPVr (400 mg/100 mg twice daily), LPVr + TLM (10 mg once daily) or LPVr + ATV (20 mg once daily) for 10 days.

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Meeting the World Health Organisation 2030 target of treating 80% of people with hepatitis C virus (HCV) in Australia requires accessible testing and treatment services for at-risk populations. Previous clinical trials, including those in Australia, have demonstrated the efficacy of outreach programmes to community pharmacies offering opioid agonist therapy (OAT). This analysis evaluates the potential cost-effectiveness of introducing an outreach programme in community pharmacies.

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The contribution of neutrophils to bacteriophage clearance and pharmacokinetics in vivo.

JCI Insight

October 2024

Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California, USA.

With the increasing prevalence of antimicrobial-resistant bacterial infections, there is interest in using bacteriophages (phages) to treat such infections. However, the factors that govern bacteriophage pharmacokinetics in vivo remain poorly understood. Here, we have examined the contribution of neutrophils, the most abundant phagocytes in the body, to the pharmacokinetics of i.

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Designing a clinical trial to evaluate the efficacy of an intervention is often complicated by uncertainty over aspects of the study population, potential treatment effects, most relevant outcomes, dropouts, and other factors. However, once participants begin to be enrolled and partial trial data become available, this level of uncertainty is reduced. Adaptive clinical trials are designed to take advantage of the accumulating data during the conduct of a trial to make changes according to prespecified decision rules to increase the likelihood of success or statistical efficiency.

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An Introduction to Bayesian Approaches to Trial Design and Statistics for Stroke Researchers.

Stroke

November 2024

Department of Diagnostic Imaging (J.M.O., S.B.C., M.D.H., M.G.), Foothills Medical Center, University of Calgary, AB, Canada.

Article Synopsis
  • Most stroke researchers currently use frequentist statistics, but there is a growing trend towards using Bayesian statistics in stroke research.
  • Bayesian statistics focus on updating the probability of parameters based on observed data and prior beliefs, allowing for more flexible interpretations of treatment effectiveness.
  • This review discusses the fundamental concepts of Bayesian statistics in stroke trials, compares them to frequentist methods with examples, and explains how to conduct and interpret Bayesian analyses.
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Article Synopsis
  • A study on the effects of statin therapy in people living with HIV (PWH) found that while it did not reduce the overall incidence of COVID-19, it may lower the risk of severe cases of COVID-19 before vaccination.
  • The study analyzed data from 6,905 PWH and included variables such as age, gender, and race, showing that a majority had received COVID-19 vaccinations by the end of the study period.
  • Statin therapy demonstrated a potential protective effect against serious COVID-19 cases, as evidenced by a hazard ratio of 0.75, but the results were inconclusive due to fewer cases than expected.
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Generating and translating evidence for safe and effective medication management in aged care homes.

Br J Clin Pharmacol

January 2025

Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville Campus, Parkville, Victoria, Australia.

Generating and translating high-quality evidence is integral to providing safe and effective medication management for residents of aged care homes. Residents are often under-represented in trials of medication effectiveness and safety. This paper reviews opportunities and challenges for generating and translating evidence for safe and effective medication management in aged care homes.

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Combination of Pretarsal and Preseptal Botulinum Toxin Injections in the Treatment of Blepharospasm: A Prospective Nonrandomized Clinical Trial.

Am J Ophthalmol

February 2025

From the Department of Neurology, Xijing Hospital, Air Force Medical University (J.H., Q.M., F.M., H.W., M.S.), Xi'an, Shaanxi Province, China. Electronic address:

Article Synopsis
  • The study aimed to compare the effectiveness of two botulinum toxin injection methods—pretarsal combined with preseptal (PT-PS) versus conventional pretarsal (PT)—for treating benign essential blepharospasm (BEB).
  • Conducted as a prospective nonrandomized clinical trial with 95 injections across 45 patients, the researchers measured outcomes using the Jankovic Rating Scale and Blepharospasm Disability Index.
  • Results indicated that PT-PS injections resulted in faster response times, longer effects, higher patient satisfaction, and a similar safety profile compared to PT injections, making PT-PS a more favorable option for BEB treatment.
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Aims: Racial disparities exist in clinical outcomes for valvular heart disease (VHD). It is unknown whether clinician segregation contributes to these disparities. Among an adequately insured population, we evaluated the relationship between clinician segregation in a hospital and receipt of care by a cardiologist according to patient race.

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Bacterial meningitis (BM) is a critical central nervous system infection characterized by increased risks of complications and potentially fatal outcomes. The chances of full recovery are significantly reduced in the presence of concomitant neurovascular complications such as ischemic and hemorrhagic strokes, intracerebral hemorrhage, and cerebral sinus thrombosis. Effective treatment of BM requires a targeted approach that simultaneously addresses the causative pathogen and manages the neurologically related complications.

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Article Synopsis
  • Regulation of dopamine activity is crucial for treating conditions like schizophrenia, with LB-102 being a new dopamine D/5-HT inhibitor aimed at this purpose.
  • The study measured how effectively LB-102 occupied dopamine receptors in healthy volunteers using PET scans at various doses, finding that 50 mg consistently provided the desired occupancy over 24 hours.
  • Results indicated that while steady dosing led to consistent receptor occupancy, the relationship between receptor occupancy and plasma concentrations was different than usual, and LB-102 was safe and well-tolerated across all tested doses.
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Longitudinal Evaluation of Individuals With Severe Alpha-1 Antitrypsin Deficiency (Pi∗ZZ Genotype).

Gastroenterology

February 2025

Medical Clinic III, Gastroenterology, Metabolic Diseases and Intensive Care, University Hospital RWTH Aachen, Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN RARE LIVER), Aachen, Germany. Electronic address:

Background & Aims: Homozygous Pi∗Z mutation in alpha-1 antitrypsin (Pi∗ZZ genotype) predisposes to pulmonary loss-of-function and hepatic gain-of-function injury. To facilitate selection into clinical trials typically targeting only 1 organ, we systematically evaluated an international, multicenter, longitudinal, Pi∗ZZ cohort to uncover natural disease course and surrogates for future liver- and lung-related endpoints.

Methods: Cohort 1 recruited 737 Pi∗ZZ individuals from 25 different centers without known liver comorbidities who received a baseline clinical and laboratory assessment as well as liver stiffness measurement (LSM).

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The high cancer burden in the Middle East and North Africa (MENA region) is coupled with an increasing cancer incidence. While the MENA region constitutes 6% of the world's population, it remains underrepresented in clinical trials. Cutaneous T-cell lymphomas (CTCLs) represent a heterogeneous group of rare extranodal non-Hodgkin lymphomas with variable clinical presentation.

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Background: Metabolic dysfunction-associated steatohepatitis (MASH) is a growing global health concern with no effective pharmacological treatments. SNP-630, a newly developed synthetic molecule with multiple mechanisms of action, and a mixture of two of its active metabolites (SNP-630-MS) inhibit CYP2E1 expression to prevent reactive oxygen species generation, thereby reducing the accumulation of hepatic triglycerides and lowering chemokine levels. This study investigated the SNP-630's potential to alleviate the liver injury in MASH and its efficacy in both a mouse model and patients with MASH to identify a drug candidate that targets multiple pathways implicated in MASH.

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Effect of CPAP therapy on blood pressure in patients with obstructive sleep apnoea: a worldwide individual patient data meta-analysis.

Eur Respir J

January 2025

Department of Cardiovascular, Neural and Metabolic Sciences, Istituto Auxologico Italiano IRCCS, Milan, Italy.

Background: Obstructive sleep apnoea (OSA) is associated with hypertension, and OSA treatment can reduce systolic blood pressure (SBP) and diastolic blood pressure (DBP), but with a modest mean effect size and vast heterogeneity among studies. The aim of this individual patient data (IPD) meta-analysis was to understand which OSA phenotypes could benefit the most in terms of BP reduction.

Methods: A systematic review of randomised controlled trials that compared continuous positive airway pressure (CPAP) with either passive or active treatment was conducted.

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This commentary explores the potential cardiovascular (CV) benefits of combining methotrexate (MTX) and Janus kinase inhibitors (JAKis) in the treatment of rheumatoid arthritis (RA). While European guidelines recommend MTX as first-line treatment, concerns about the CV risks associated with JAKis have emerged. This article reviews the existing literature to assess the role of concomitant MTX in reducing CV risk when used with JAKis.

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Efficacy of medications for the treatment of alcohol use disorder (AUD): A systematic review and meta-analysis considering baseline AUD severity.

Pharmacol Res

November 2024

Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Laboratory for Psychiatric Neurogenomics, McLean Hospital, Belmont, MA, USA.

Baseline severity of alcohol use disorder (AUD) is an influencing factor in the response to medications recommended for the treatment of AUD. The scarce efficacy of AUD medications partly justifies their limited uses. We were interested in evaluating the efficacy of approved and recommended AUD medications using generic inverse-variance, an analysis facilitating comparison between medications and placebo both at the end of the study and, concomitantly, to baseline values for the same participants.

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Article Synopsis
  • Simlukafusp alfa (FAP-IL2v) is an engineered immune cytokine aimed at enhancing immune responses specifically in tumor environments, and was evaluated with atezolizumab for treating recurrent/metastatic cervical squamous cell carcinoma (SCC) in a phase 2 study.
  • A total of 48 patients with advanced cervical SCC who had previously received treatment were enrolled; the study primarily measured the objective response rate, yielding a 27% response with a median duration of 13.3 months for those who responded.
  • The combination treatment showed clinical efficacy with manageable side effects, including immune cell activation, indicating a promising approach for this patient group.
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The effect of colchicine on myocardial infarction: An updated systematic review and meta-analysis of randomized controlled trials.

Curr Probl Cardiol

January 2025

Nursing & Midwifery Research Department (NMRD), Hamad Medical Corporation, Doha, Qatar; Department of Public Health, College of Health Sciences, QU Health, Qatar University, Doha, Qatar. Electronic address:

Article Synopsis
  • Myocardial infarction (MI) causes significant inflammation that affects recovery, and colchicine, an anti-inflammatory drug, may help reduce adverse cardiovascular events in post-MI patients.
  • This meta-analysis reviewed randomized controlled trials to assess colchicine's effectiveness and safety, focusing on multiple cardiovascular outcomes including mortality and adverse events.
  • Results from eleven studies involving over 7,000 patients showed that colchicine significantly lowered the risk of adverse cardiovascular events and hospitalization urgency, but it also increased gastrointestinal issues without affecting overall mortality rates.
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Interstitial Lung Abnormality: Narrative Review of the Approach to Diagnosis and Management.

Chest

October 2024

Division of Pulmonary and Critical Care Medicine, Lenox Hill Hospital, Northwell Health, New York NY. Electronic address:

Topic Importance: As interstitial lung abnormalities (ILAs) are increasingly recognized on imaging and in clinical practice, identification and appropriate management are critical. We propose an algorithmic approach to the identification and management of patients with ILAs.

Review Findings: The radiologist initially identifies chest CT scan findings suggestive of an ILA pattern and excludes findings that are not consistent with ILAs.

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Article Synopsis
  • Preterm infants often face the risk of respiratory failure after being extubated from invasive ventilation, and this can occur due to issues like apnoea and hypoxia. Traditionally, they were extubated to head box oxygen or low-flow nasal cannulas, but non-invasive support such as nasal continuous positive airway pressure (NCPAP) may enhance extubation success by stabilizing the airway and improving lung function.
  • The objective of the reviewed study is to find out if using NCPAP right after extubation can lower the occurrence of reintubation and the need for further ventilatory support in preterm infants, while ensuring there are no significant negative side effects.
  • For
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Background: Early assessment of patients with suspected transient ischaemic attack (TIA) is crucial to provision of effective care, including initiation of preventive therapies and identification of stroke mimics. Many patients with TIA present to emergency medical services (EMS) but may not require hospitalisation. Paramedics could identify and refer patients with low-risk TIA, without conveyance to the ED.

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Article Synopsis
  • Early phase clinical trials focus on evaluating the safety and tolerability of new therapies, primarily using investigator and lab results rather than patient feedback.
  • A recent expert roundtable brought together 22 stakeholders to discuss the need for a universal patient-reported outcomes (PRO) model in early phase trials and how to effectively incorporate PROs to assess tolerability and guide treatment decisions.
  • The discussions yielded key recommendations and identified priority areas for further research on integrating patient feedback into early trials to improve safety and symptom management.
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