7,028 results match your criteria: "c Medical Services and Clinical Trials; Research and Development[Affiliation]"

Prophylactic Antibiotics in Adults With Acute Brain Injury Who Are Invasively Ventilated in the ICU: A Systematic Review and Meta-Analysis.

Chest

October 2024

Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St. Leonards, NSW, , Australia; Critical Care Program, The George Institute for Global Health and UNSW, Barangaroo, NSW, Australia; Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Australia. Electronic address:

Background: Lower respiratory tract infections are common in patients receiving invasive mechanical ventilation in an ICU after an acute brain injury and may have deleterious consequences.

Research Question: In adults with acute brain injury receiving invasive mechanical ventilation in an ICU, is the administration of prophylactic parenteral antibiotics, compared with placebo or usual care, associated with reduced mortality?

Study Design And Methods: We conducted a systematic review and meta-analysis. We searched for randomized clinical trials (RCTs) in electronic databases, as well as unpublished trials.

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This post-hoc analysis of the SABINA III study evaluated the association of short-acting β-agonist (SABA) prescriptions and self-reported over-the-counter (OTC) SABA purchase in the previous 12 months with asthma-related outcomes using multivariable regression models in 4556 patients (mean age, 48.9 years). Of the 2810 patients prescribed ≥3 SABA canisters, 776 (27.

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Care of Pregnant Women Living with Human Immunodeficiency Virus.

Clin Perinatol

December 2024

Division of Maternal Fetal Medicine, Department of Gynecology & Obstetrics, School of Medicine, Johns Hopkins University, 600 N Wolfe Street, Phipps 228, Baltimore, MD, USA. Electronic address: https://twitter.com/AhizechukwuEke.

Article Synopsis
  • Managing HIV during pregnancy involves addressing both medical needs and the psychological aspects of the mother's health.
  • Effective care plans aim to maintain low HIV levels and enhance the mother's overall health before conception.
  • The article discusses the use of antiretroviral drugs, pregnancy outcomes for mothers with HIV, and the importance of a comprehensive approach to care.
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Article Synopsis
  • Cardiac amyloidosis (CA) is an often overlooked cause of heart failure (HF), highlighting the importance of early detection and timely therapy for better patient outcomes.
  • A global survey with 1,460 physicians revealed that while many have experience diagnosing CA in patients with preserved ejection fraction (HFpEF), systematic screening is not widely practiced, with only 10% conducting routine checks.
  • There is significant variability in screening and management strategies for CA, indicating a need for better education and access to disease-modifying therapies within the HF community.
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Intraosseous or Intravenous Vascular Access for Out-of-Hospital Cardiac Arrest.

N Engl J Med

January 2025

From Prehospital Emergency Medical Services, Central Denmark Region (M.F.V., A.L.P., A.H.P., S.W., L.W.F., C.M., K.B.W., A.B., T.H.D., L.K.R., L.R.M., M.L.L., T.E., A.G.N., C.R., L.W.A.), the Department of Clinical Medicine, Aarhus University (M.F.V., A.G., C.J.T., S.C., L.W.A.), and the Departments of Anesthesiology and Intensive Care (A.G., M.J.H., T.H.D., S.C., C.G.N., B.S., L.W.A.), Cardiology (C.J.T.), and Radiology (E.K.), Aarhus University Hospital, Aarhus, the Department of Anesthesiology and Intensive Care, Aalborg University Hospital (T.L.K., F.M.N.), the Center for Prehospital and Emergency Research, Department of Clinical Medicine, Aalborg University and Aalborg University Hospital (E.F.C.), and Emergency Medical Services, North Denmark Region (P.B.), Aalborg, the Prehospital Research Unit (S.M., P.M.H.) and Emergency Medical Services (J.H.H., M.B., L.-G.R.N., M.P., G.K.-A., P.M.H.), Region of Southern Denmark, the Department of Anesthesiology and Intensive Care, Odense University Hospital (J.H.H., M.B.), and the Department of Regional Health Research, University of Southern Denmark (A.C.B.), Odense, the Departments of Cardiology (F.F.) and of Anesthesiology and Intensive Care (L.R.), Copenhagen University Hospital, Gentofte Copenhagen University Hospital-Emergency Medical Services, Ballerup (F.F., J.W.B., H.A., S.H., T.H.F.), the Department of Clinical Medicine, University of Copenhagen (F.F., H.C.C., L.R., M.K.), and the Department of Cardiology, the Heart Center, Copenhagen University Hospital, Rigshospitalet (L.E.R.O., S.L.D.H.), Copenhagen, the Prehospital Center, Region Zealand, Næstved (H.C.C.), the Department of Anesthesiology and Intensive Care, Gødstrup Regional Hospital, Gødstrup (L.K.R.), the Department of Anesthesiology and Intensive Care, Randers Regional Hospital, Randers (L.R.M., T.E.), the Department of Anesthesiology and Intensive Care, Viborg Regional Hospital, Viborg (A.G.N.), the Elective Surgery Center, Silkeborg Regional Hospital, Silkeborg (C.R.), the Department of Anesthesiology and Intensive Care, University Hospital of Southern Denmark, Esbjerg and Grindsted, Esbjerg (L.-G.R.N.), the Department of Anesthesiology and Intensive Care, University Hospital of Southern Denmark, Kolding (M.P., A.C.B.), the Department of Anesthesiology and Intensive Care, University Hospital of Southern Denmark, Aabenraa (G.K.-A.), the Department of Anesthesiology and Intensive Care, Svendborg Hospital, Svendborg (P.M.H.), the Department of Anesthesiology and Intensive Care, Copenhagen University Hospital, Herlev (H.A.), the Department of Anesthesiology and Intensive Care, Copenhagen University Hospital-North Zealand, Hillerød (S.H.), the Department of Anesthesiology and Intensive Care, Zealand University Hospital, Køge (J.U.H.B.), the Department of Anesthesiology and Intensive Care, Nykøbing Falster Hospital, Nykøbing Falster (K.J.), the Department of Anesthesiology and Intensive Care, Holbæk Hospital, Holbæk (M.K.), and the Department of Anesthesiology and Intensive Care, Slagelse Hospital, Slagelse (M.S.) - all in Denmark.

Article Synopsis
  • Out-of-hospital cardiac arrest is a major global health issue, necessitating effective vascular access for drug administration during resuscitation.
  • A clinical trial comparing intraosseous and intravenous methods found that both had similar effectiveness for restoring circulation, with around 30% of patients in each group succeeding.
  • At 30 days post-arrest, survival rates and favorable neurologic outcomes also showed no significant differences between the two methods, indicating both approaches are equally viable.
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A Randomized Trial of Drug Route in Out-of-Hospital Cardiac Arrest.

N Engl J Med

January 2025

From the Warwick Medical School, Clinical Trials Unit, University of Warwick (K.C., C.J., J.P.N., J.B.L., J.M.M., F.M., C.N., H.N., A.-M.S., M.A.S., K.R.S., S.W., R.L., G.D.P.), and the Critical Care Unit, University Hospital Coventry and Warwickshire NHS Trust (M.A.S.), Coventry, Devon Air Ambulance (N.L., B.T.) and South Western Ambulance Service NHS Foundation Trust (R.O., S.W.), Exeter, East Midlands Ambulance Service NHS Trust, Nottingham (R.E.S.S., G.L.S., G.A.W.), East of England Ambulance Service NHS Trust, Cambridge (S.B., T.F.), Kingston University (T.Q.) and London Ambulance Service NHS Trust (R.T.F., J.K., J.F., A.M.-S.), London, North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne (K.C., E.B., M.L.), North West Ambulance Service NHS Trust, Bolton (S.B., A. Wright, M.W.), South Central Ambulance Service NHS Foundation Trust, Bicester (C.D.D., M.B., A.C., V.D.), South East Coast Ambulance Service NHS Foundation Trust, Crawley (G.B., J.W.), Welsh Ambulance Services University NHS Trust, Cwmbran (C.M., N.R.), West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill (A. Walker, C.E., J.M., J.V.W.), the Critical Care Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham (G.D.P., K.C.), the Emergency Department, Harrogate and District NHS Foundation Trust, Harrogate (A. Walker), the Department of Anaesthesia, Royal United Hospitals Bath NHS Foundation Trust, Bath (J.P.N.), University Hospital Southampton NHS Foundation Trust, Southampton (C.D.D.), and the University of Bristol, Bristol (J.P.N.) - all in the United Kingdom.

Background: In patients with out-of-hospital cardiac arrest, the effectiveness of drugs such as epinephrine is highly time-dependent. An intraosseous route of drug administration may enable more rapid drug administration than an intravenous route; however, its effect on clinical outcomes is uncertain.

Methods: We conducted a multicenter, open-label, randomized trial across 11 emergency medical systems in the United Kingdom that involved adults in cardiac arrest for whom vascular access for drug administration was needed.

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Background: Inflammation promotes atherogenesis. Randomized controlled trials of anti-inflammatory therapies for prevention after stroke have not yet demonstrated clear benefit. IL-6 (interleukin-6) and hsCRP (high-sensitivity C-reactive protein) are independently associated with major adverse cardiovascular events poststroke and may guide patient selection in future randomized controlled trials.

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Inavolisib-Based Therapy in -Mutated Advanced Breast Cancer.

N Engl J Med

October 2024

From the Royal Marsden Hospital and Institute of Cancer Research (N.C.T.) and the Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London (P. Schmid), London, and Roche, Welwyn Garden City (E.T., G.L.) - all in the United Kingdom; Seoul National University Hospital, Seoul National University College of Medicine, Cancer Research Institute, Seoul National University, Seoul, South Korea (S.-A.I.); Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona (C. Saura); Mass General Cancer Center, Department of Medicine, Harvard Medical School, Boston (D.J.); Winship Cancer Institute at Emory University, Atlanta (K.K.); Genentech, San Francisco (N.S., T.J.S., K.E.H., J.L.S., C. Song); the Breast and Early Drug Development Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College - both in New York (K.L.J.); the German Breast Group, Neu-Isenburg, and the Center for Hematology and Oncology Bethanien, Goethe University, Frankfurt - both in Germany (S. Loibl); the Division of Cancer Research and Clinical Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, and the Sir Peter MacCallum Department of Medical Oncology, University of Melbourne, Parkville, VIC - both in Australia (S. Loi); the Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand (P. Sunpaweravong); the Department of Medicine, University of Parma, Parma, and the Medical Oncology and Breast Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori," Meldola - both in Italy (A.M.); the Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Department of Breast Oncology, Peking University Cancer Hospital and Institute, Beijing (H.L.), Harbin Medical University, Harbin (Q.Z.), and the University Department of Medicine, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong (R.L.) - all in China; and Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland (Z.N.).

Article Synopsis
  • * In a phase 3 trial involving 325 patients, those taking inavolisib had a median progression-free survival of 15.0 months, significantly better than the 7.3 months for the placebo group, indicating better disease management.
  • * The treatment with inavolisib showed promising results with a 58.4% objective response rate; however, there were notable side effects, similar between both groups, including high rates of neutropenia
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Recommendations to promote equity, diversity and inclusion in decentralized clinical trials.

Nat Med

November 2024

Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.

Decentralized clinical trials involving the use of digital tools to facilitate remote research are gaining momentum. Rapid advancements in digital technologies have supported the adoption of these trials. These innovations facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer and store electronic data.

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Chimeric antigen receptor (CAR) T-cell therapy has transformed the care of lymphoma, yet many patients relapse. Several prognostic markers have been associated with CAR T-cell outcomes, such as tumor burden, response to bridging chemotherapy, and laboratory parameters at the time of lymphodepletion or infusion. The effect of cancer cachexia and weight loss before CAR T cells on toxicity and outcomes is not well understood.

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Background And Purpose: Disabling dystonia despite optimal medical treatment is common in Wilson disease (WD). No controlled study has evaluated the effect of deep brain stimulation (DBS) on dystonia related to WD. This study was undertaken to evaluate the efficacy of DBS on dystonia related to WD.

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Background: Relapse of depression is common and contributes to the overall associated morbidity and burden. We lack evidence-based tools to estimate an individual's risk of relapse after treatment in primary care, which may help us more effectively target relapse prevention.

Objective: The objective was to develop and validate a prognostic model to predict risk of relapse of depression in primary care.

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Objectives: Allergic bronchopulmonary aspergillosis (ABPA) is a complex lung disease associated with significant morbidity. The ABPA Working Group (AWG) of the International Society for Human and Animal Mycology (ISHAM) revised their management guidelines in 2024, but there is currently no standardised tool to assess adherence to these recommendations.

Methods: We extracted key recommendations from the updated 2024 ISHAM-AWG guidelines, focusing on critical areas: screening and diagnosis of ABPA, managing acute and treatment-dependent ABPA, and monitoring treatment response.

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Objective: This study was undertaken to assess long-term safety, tolerability, and efficacy of lacosamide (LCM) as adjunctive therapy for generalized onset tonic-clonic seizures (GTCS) in patients aged ≥4 years with idiopathic generalized epilepsy (IGE).

Methods: EP0012 (NCT02408549) was a phase 3, multicenter, open-label extension (OLE) trial. Patients were enrolled from SP0982 (NCT02408523).

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Article Synopsis
  • Semaglutide, a drug for type 2 diabetes, shows promise in reducing albuminuria and slowing kidney disease progression in patients with chronic kidney disease (CKD) in a double-blind clinical trial.
  • The study involved 101 participants, comparing those receiving 2.4 mg of semaglutide weekly to a placebo, with a focus on changes in urine albumin-to-creatinine ratio after 24 weeks.
  • Results indicated a significant 52.1% reduction in albuminuria for the semaglutide group, although gastrointestinal side effects were more common compared to the placebo group.
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Background: Protein biomarkers that reflect different pathophysiological pathways have been associated with the risk of adverse cardiovascular events. However, it is uncertain whether these associations are sustained with increasing years after the biomarkers are measured.

Methods And Results: In this cohort study, 7745 patients with coronary heart disease who participated in the LIPID (Long-Term Intervention With Pravastatin in Ischemic Disease) trial, BNP (B-type natriuretic peptide), troponin I, cystatin-C, C-reactive protein, d-dimer and midregional proadrenomedullin were measured at baseline and after 1 year.

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First-in-Human Phase I Clinical Trial of the Adenosine A1R/A3R Agonist AST-004 in Healthy Subjects.

Stroke

December 2024

Astrocyte Pharmaceuticals, Inc, Groton, CT (L.M.M., J.H., D.E.H., M.A.M., T.E.L., R.B.P., W.S.K., R.A.L.).

Article Synopsis
  • - AST-004 is a small molecule that targets adenosine receptors and shows promise for protecting the brain after strokes and injuries, aiming to assess its safety and how it's processed in the body during a phase I clinical trial on healthy individuals.
  • - The study involved giving varying doses of AST-004 to different groups of participants and then analyzing its levels in blood, cerebrospinal fluid (CSF), and urine; no serious side effects were observed, though headaches were reported by some.
  • - Findings indicated that AST-004 is safe at higher concentrations than previously effective in animal studies and that it reaches highest levels in CSF an hour after infusion, suggesting it may be suitable for further testing in treating strokes and brain injuries.
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Background Recent biomedical research has emphasized the potential of biocomposite materials for medicinal purposes. This work investigates the combination of magnesium oxide (MgO)-doped chitosan and polyvinyl alcohol (PVA) with extracts from , a medicinal plant renowned for its abundant alkaloid content and therapeutic advantages. The antioxidant, anti-inflammatory, and anti-cancer characteristics of this unique biocomposite material are being studied better to understand its prospective uses in biomedicine.

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Article Synopsis
  • A multicenter phase 1b study explored the effectiveness and tolerability of combining spartalizumab with various platinum-doublet chemotherapy regimens in treatment-naïve patients with non-small cell lung cancer (NSCLC) that were not selected based on PD-L1 expression.
  • The study found that the maximum tolerated dose for spartalizumab was 300 mg every 3 weeks, and overall response rates to the treatment generally ranged from 51.5% to 57.6%, indicating a good level of efficacy across different chemotherapy combinations.
  • Notably, patients receiving pemetrexed/cisplatin showed the longest median progression-free survival and overall survival compared to other treatment groups, highlighting the potential of this regimen in
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Type 1 diabetes treatment stands at a crucial and exciting crossroad since the 2022 U.S. Food and Drug Administration approval of teplizumab to delay disease development.

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Does targeted temperature management at 33 °C improve outcome after cardiac arrest?

Curr Opin Crit Care

December 2024

Mount Sinai Professor and System Chair, Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai.

Purpose Of Review: Following successful resuscitation from cardiac arrest, a complex set of pathophysiologic processes are acutely triggered, leading to substantial morbidity and mortality. Postarrest management remains a major challenge to critical care providers, with few proven therapeutic strategies to improve outcomes. One therapy that has received substantial focus is the intentional lowering of core body temperature for a discrete period of time following resuscitation.

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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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