1,221 results match your criteria: "and ‡Late Clinical Research and Development[Affiliation]"

Background: Current methods for evaluating liver health rely on nonspecific blood tests, elastography surrogates for fibrosis, and invasive procedures, none of which directly measure liver function and physiology. Herein we present the analytical validation of a unique, highly sensitive LC-MS/MS assay and dual-sample oral (DuO) cholate challenge test to reliably quantify serial serum concentrations of cholate isotopes administered to patients with liver diseases. The clearance of administered cholate isotopes measured by the assay provides information about liver function and physiology.

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  • The study aimed to compare the efficacy, safety, and immunogenicity of a new treatment (P043) for allergic asthma with the established drug, Xolair (omalizumab), focusing on the rate of asthma exacerbations.
  • Over a 28-week trial with 256 participants, results showed that both treatments had similar rates of exacerbations, asthma control test scores, and spirometry measurements, indicating that P043 is as effective as omalizumab.
  • Adverse events reported were comparable between both groups, with common issues being dyspnea and headache, and no significant issues with drug safety or immunogenicity observed for either treatment.
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The Effect of Thickened Water on Ciprofloxacin Pharmacokinetics: A Comparative Study in Adult Males.

J Clin Med

August 2024

Department of Clinical Research and Development, Graduate School of Pharmacy, Showa University, Tokyo 157-8577, Japan.

Article Synopsis
  • The use of food thickeners with ciprofloxacin can alter the drug’s appearance and slow down its dissolution, potentially affecting its effectiveness and posing economic concerns in healthcare.
  • A study was conducted on healthy Japanese males to compare how different methods of taking ciprofloxacin (with water, thickened water, and crushed tablets in thickened water) affect drug absorption.
  • Results showed that while thickened water changed drug absorption, crushed tablets in thickened water provided similar absorption metrics as tablets with regular water, though crushing may risk losing active ingredients and requires careful consideration.
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We investigated the potential diagnostic role of galectin-3 (Gal-3) in patients presenting with suspected acute coronary syndromes (ACS). We searched PubMed Central, Scopus, EMBASE, and the Cochrane Library from inception until 20 June 2024. We measured effect sizes using odds ratios (OR) with 95% CIs for dichotomous data and mean differences (MD) with CIs for continuous data.

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Background: On December 2019, a novel coronavirus disease (COVID-19) spread worldwide and became a pandemic. Multisystem inflammatory syndrome in children (MIS-C) due to cytokine release syndrome following COVID-19 presents with various manifestations. We hypothesize that one of the rare manifestations is acute abdomen.

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  • Immunochemotherapy is currently the primary treatment for newly diagnosed diffuse large B-cell lymphoma (ndDLBCL), but it's ineffective for some patients, prompting research into better prognostic methods.
  • By analyzing transcriptomic data from a large group of patients, researchers identified seven distinct clusters of ndDLBCL, with one specific cluster (A7) linked to poorer outcomes due to characteristics like low immune cell presence and high MYC expression.
  • The study also explores how certain drugs, like lenalidomide, may improve treatment for the high-risk A7 cluster by enhancing T-cell movement into tumors and the expression of key tumor markers, while identifying TCF4 as a crucial factor in MYC biology for this group.
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Background: Aesthetic medicine has traditionally relied on clinical scales for the objective assessment of baseline appearance and treatment outcomes. However, the scales focus on limited aesthetic areas mostly and subjective interpretation inherent in these scales can lead to variability, which undermines standardization efforts.

Objective: The consensus meeting aimed to establish guidelines for AI application in aesthetic medicine.

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Background: In May 2020, England implemented soft 'opt-out' or 'deemed consent' for deceased donation with the intention of raising consent rates. However, this coincided with the COVID-19 pandemic, making it difficult to assess the early impact of the law change. Wales and Scotland changed their organ donation legislation to implement soft opt-out systems in 2015 and 2021 respectively.

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Long-term inhaled corticosteroid treatment in patients with chronic obstructive lung disease, cardiovascular disease, and recent hospitalization for exacerbation.

Eur J Intern Med

November 2024

Department of Clinical Research and Development, LUXMED Group, Warsaw, Poland; Institute of Outcomes Research, Maria Sklodowska-Curie Medical Academy, Warsaw, Poland; Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA. Electronic address:

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Introduction: To evaluate the efficacy, safety, pharmacokinetics (PK), and immunogenicity of ZRC-3277 (pertuzumab biosimilar) with Perjeta® (pertuzumab) in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).

Patients And Methods: This phase III, multicenter, double-blind study across 38 sites in India randomized (1:1) patients with HER2-positive MBC in either the ZRC-3277 or Perjeta® group. Both groups also received trastuzumab and docetaxel.

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VISCERAL SENSITIVITY INDEX (VSI-IT): Italian Adaptation and Validation.

Eur J Investig Health Psychol Educ

July 2024

Post-Graduate School of Occupational Medicine, Faculty of Medicine and Surgery, Catholic University of the Sacred Heart, 00168 Rome, Italy.

Article Synopsis
  • * A study tested the Italian VSI on 500 participants, including patients with Crohn's disease, ulcerative colitis, IBS, and healthy controls, ensuring accurate translation and implementation through an online survey.
  • * The results showed that the Italian VSI is reliable and valid, effectively identifying differences in sensitivity and correlating with symptoms, thus aiding in better understanding and treatment of gastrointestinal disorders in Italy.
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  • Cushing's syndrome, particularly Cushing's disease, presents diagnostic challenges that this study aims to address using the desmopressin stimulation test (DST) to differentiate between various causes of ACTH-dependent forms of the syndrome.
  • Twenty-three patients underwent a series of tests, including DST and surgeries, while the effectiveness of DST was measured by its sensitivity, specificity, and other predictive values to assess diagnostic performance.
  • Results indicated that DST demonstrates strong sensitivity and positive predictive value, suggesting it could be a valuable non-invasive method for diagnosing ACTH-dependent Cushing's syndrome with further validation needed for its routine use in clinical settings.
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Key Clinical Message: Clinicians should carefully consider generalized lymphadenopathy, particularly post viral infections, as one of the possible systemic lupus erythematous (SLE) first signs regarding unusual joint involvements such as sacroiliitis. Late diagnosis of this autoimmune inflammatory disease, could lead to irreversible morbidity and higher mortality.

Abstract: Lymphadenopathy could represent various etiologies, including infections, malignancies, and rheumatologic diseases.

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Minimum effective dose of clemastine in a mouse model of preterm white matter injury.

Pediatr Res

September 2024

Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.

Article Synopsis
  • Preterm white matter injury (PWMI) is a primary cause of brain injury in premature infants, and clemastine has shown promise in promoting myelination in affected mouse models at a dose of 10 mg/kg/day.* -
  • This study aimed to determine the minimum effective dose (MED) of clemastine in neonatal mice, hypothesizing it to be lower than 10 mg/kg/day; they found the MED to be 7.5 mg/kg/day for rescuing hypoxia-induced hypomyelination.* -
  • The results highlight the potential for clemastine as a treatment for PWMI, providing essential data on dosing and pharmacokinetics that will aid future clinical trials in neonates
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Breast milk contains numerous factors that are involved in the maturation of the immune system and development of the gut microbiota in infants. These factors include transforming growth factor-β1 and 2, immunoglobin A, and lactoferrin. Breast milk factors may also affect epidermal differentiation and the stratum corneum (SC) barrier in infants, but no studies examining these associations over time during infancy have been reported.

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We are grateful for the insightful comments provided by the author [...

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Cannabichromene (CBC) is a minor cannabinoid within the array of over 120 cannabinoids identified in the plant. While CBC does not comprise a significant portion of whole plant material, it is available to the public in a purified and highly concentrated form. As minor cannabinoids become more popular due to their potential therapeutic properties, it becomes crucial to elucidate their metabolism in humans.

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Current evidence suggests that airborne pollutants have a detrimental effect on fetal growth through the emergence of small for gestational age (SGA) or term low birth weight (TLBW). The study's objective was to critically evaluate the available literature on the association between environmental pollution and the incidence of SGA or TLBW occurrence. A comprehensive literature search was conducted across Pubmed/MEDLINE, Web of Science, Cochrane Library, EMBASE, and Google Scholar using predefined inclusion and exclusion criteria.

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Introduction: Chemotherapy for breast cancer can cause neutropenia, increasing the risk of febrile neutropenia (FN) and serious infections. The use of granulocyte colony-stimulating factors (G-CSF) as primary prophylaxis has been explored to mitigate these risks. To evaluate the efficacy and safety of primary G-CSF prophylaxis in patients with invasive breast cancer undergoing chemotherapy.

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