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

Background: A broad-spectrum anti-SARS-CoV-2 monoclonal antibody (mAb), SA55, is highly effective against SARS-CoV-2 variants. This trial aimed at demonstrating the safety, tolerability, local drug retention and neutralizing activity, systemic exposure level, and immunogenicity of the SA55 nasal spray in healthy individuals.

Methods: This phase I, dose-escalation clinical trial combined an open-label design with a randomized, controlled, double-blind design.

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Comparison of Influence of Office and 24-h Central Aortic Blood Pressure on Target Organ Damage in Hypertension.

J Clin Hypertens (Greenwich)

January 2025

Department of Geriatrics, Medical Center on Aging of Shanghai Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

The aim of this study was to explore whether 24-h ambulatory central (aortic) blood pressure (BP) has an advantage over office central aortic BP in screening for hypertension-mediated target organ damage (HMOD). A total of 714 inpatients with primary hypertension and the presence of several cardiovascular risk factors or complications involving clinical HMOD were enrolled. Twenty-four hour central aortic BP was measured by means of a noninvasive automated oscillometric device (Mobil-O-Graph).

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Background: Complete Cytoreduction (CC) in ovarian cancer (OC) has been associated with better outcomes. Outcomes after CC have a multifactorial and interrelated cause that may not be predictable by conventional statistical methods. Artificial intelligence (AI) may be more accurate in predicting outcomes.

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Bioinformatics analysis of mitochondrial metabolism-related genes demonstrates their importance in renal cell carcinoma.

Discov Oncol

January 2025

Clinical Research and Development Center, Division of Nephrology, Department of Internal Medicine, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Purpose: Clear cell renal cell carcinoma (ccRCC) is resistant to radiotherapy and chemotherapy. Thus, it is necessary to find new diagnostic markers and therapeutic targets to increase the overall outcomes of ccRCC. Recent studies have shown that therapeutic methods that interfere with the energy transfer system can also positively affect the treatment process.

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Background: Residual fatigue is a common and debilitating symptom in patients with unipolar and bipolar depression, even after achieving partial or full remission. It significantly impacts patients' quality of life and increases the risk of relapse. This systematic review aims to evaluate the prevalence and effectiveness of therapeutic options for residual fatigue in individuals with unipolar major depressive disorder (MDD) and bipolar disorder (BD).

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Background: For non-small-cell lung cancer (NSCLC) patients who progressed after first-line chemotherapy, immunotherapy targeting programmed cell death (ligand) 1 has shown promising activity. However, the activity is relatively limited in patients harboring epidermal growth factor receptor (EGFR) mutations.

Objectives: This study aimed to evaluate the efficacy and safety of camrelizumab plus famitinib in previously treated patients with locally advanced and metastatic NSCLC.

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Purpose: Bladder preservation therapy in combination with atezolizumab and radiation therapy (BPT-ART) trial, which was a multicenter, open-label, single-arm phase II study, showed a promisingly high interim clinical complete response (cCR) rate of 84.4% (38/45). In the present study, we aimed to identify potential tissue biomarkers for achieving cCR via BPT-ART.

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Selecting the optimal dose of psilocybin for treating Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD) is crucial for clinical development and regulatory approval. This meta-analysis evaluates psilocybin's efficacy and safety in treating MDD to determine the optimal dose and timing for clinical trials. A systematic review and Dose-Response Network Meta-Analysis (NMA) of Randomized Placebo-Controlled Clinical Trials (RCTs) registered with PROSPERO was conducted.

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Background: Proteinuria is a key indicator of kidney damage in diabetic nephropathy, and its severity correlates with the progression of the disease. In diabetic patients, it is crucial to identify reliable predictors for proteinuria and its severity for early detection and management of kidney damage.

Materials And Methods: This cross-sectional study was conducted from November 16, 2022, to May 20, 2023, on patients with type 2 diabetes mellitus (T2DM) who were outpatients at clinics of Shahid Modarres Hospital, Tehran, Iran.

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Background: Facial palsy (FP) is a widespread condition affecting over 3 million people annually, with a complex etiology requiring tailored, multidisciplinary management. Despite advancements, there remains a lack of reliable, automated tools for objective pre- and postoperative assessment, limiting progress in treatment optimization. This study introduces the AI Research Metrics Model (CAARISMA ® ARMM) to evaluate FP severity and outcomes following microsurgical gracilis muscle transfer.

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Background: Reducing inflammation is central to the management of RA. However, commonly used markers such as CRP and ESR, along with the DAS-28 score, have shown limitations. Hematologic indices, such as platelet-lymphocyte ratio (PLR), lymphocyte-monocyte ratio (LMR), and neutrophil-lymphocyte ratio (NLR), show potential as reliable indicators of inflammation in RA.

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Significance of ongoing enhancement of Pediatric Intensive Care Unit follow-up.

Anaesth Crit Care Pain Med

December 2024

Department of Clinical Research and Development, LUXMED Group, Warsaw, Poland; Institute of Medical Science, Collegium Medicum, The John Paul II Catholic University of Lublin, Lublin, Poland; Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA. Electronic address:

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Very early-onset inflammatory bowel disease (VEO-IBD) is a distinct subtype of inflammatory bowel disease (IBD) characterized by onset before the age of 6 years, and patients often exhibit more severe clinical features. Interleukin 10 receptor alpha (IL10RA) is a hotspot mutation in the Chinese population and is associated with a poor prognosis closely linked to the onset of IBD. However, limited knowledge exists regarding how the IL10RA mutation influences the host microbiota and its role in disease development.

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Background & Aims: Enteral formulas containing predigested lipids to support the needs of patients with fat maldigestion are currently unavailable. Monoacylglycerol (MAG)-rich oils offer potential benefits for fat absorption without prior digestion, but their safety and tolerability in enteral formulas need evaluation. We assessed the safety and tolerability of a new formula containing predigested lipids in the form of MAG-rich oil.

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Risk Factors for Osteonecrosis of the Jaw in Patients with Chronic Kidney Disease: A Nested Case-Control Study.

J Bone Miner Res

December 2024

Department of Clinical Pharmacy, Division of Clinical Research and Development, School of Pharmacy, Showa University, Tokyo, Japan.

Osteonecrosis of the jaw (ONJ) is a severe disease leading to decreased quality of life, but risk factors for ONJ in chronic kidney disease (CKD) patients remain unclear. We conducted a nested case-control study using a large Japanese administrative database to investigate. CKD patients were identified based on estimated glomerular filtration rate (eGFR) measurements, and ONJ cases were identified using ICD-10 codes and diagnostic terms.

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Perirenal adipose tissue (PRAT) has been identified as an important factor in local and general homeostasis of the human body and is especially important in regulating renal and cardiovascular functions. It has also been identified as a crucial risk factor to consider in cardiovascular and renal disorders, malignancies, and various other diseases. Having a concrete idea of the effects of therapeutic interventions on the size and metabolism of the PRAT could prove highly beneficial.

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Article Synopsis
  • The text discusses the importance of forecasting future health issues in the USA for effective planning and public awareness regarding disease and injury burdens.
  • It describes the methodology for predicting life expectancy, cause-specific mortality, and disability-adjusted life-years (DALYs) from 2022 to 2050 using the Global Burden of Diseases framework.
  • The forecasting includes various scenarios to assess the potential impacts of health risks and improvements across the country, focusing on demographic trends and health-related risk factors.
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Quantification of 11 kratom alkaloids including mitragynine and its main metabolites in human plasma using LC-MS/MS.

Anal Bioanal Chem

February 2025

iC42 Clinical Research and Development, Department of Anesthesiology, Anschutz Medical Campus, University of Colorado, 12705 E Montview Blvd, Suite 200, Aurora, CO, 80045, USA.

Recently in the USA, kratom consumers increasingly report use of the plant for self-treatment of mood ailments, the lack of energy, chronic pain, and opioid withdrawal and dependence. Several alkaloids are present in kratom leaves, but limited data are available on their pharmacokinetics/pharmacodynamics, except for mitragynine. To support clinical studies, a high-performance liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of 11 kratom alkaloids in human plasma was developed and validated.

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Article Synopsis
  • This text references a correction to an article identified by the DOI number 10.3389/fendo.2024.1447750.
  • The correction likely addresses errors or inaccuracies found in the original publication.
  • It highlights the importance of maintaining accuracy and credibility in scientific literature.
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Peri-operative venous thromboembolism prophylaxis.

Eur J Anaesthesiol

January 2025

From the Department of Clinical Research and Development, LUXMED Group, Warsaw, Poland (MP, LS), Department of Public Health, International European University, Kyiv, Ukraine (MP), Laboratory for Experimental Medicine and Innovative Technologies, Department of Emergency Medical Service, Wroclaw Medical University, Wroclaw (JS, LS), Institute of Outcomes Research, Maria Sklodowska-Curie Medical Academy, Warsaw, Poland (LS), and Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine, Houston, Texas, USA (LS).

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Aims: This study aimed to assess the safety, pharmacokinetics and pharmacodynamics of noiiglutide (SHR20004), a novel glucagon-like peptide-1 receptor agonist, in Chinese obese participants without diabetes mellitus (DM).

Materials And Methods: This phase 1, randomised, double-blind, placebo-controlled study enrolled adult participants with body mass index (BMI) ≥28 kg/m. The study used a titration method, each subject received daily noiiglutide injection for 3-6 weeks, until reaching the final dose of 0.

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Background: Pain in the knee joint area and reduced sleep quality are prevalent symptoms of knee osteoarthritis. This study examines the impact of self-administered acupressure on pain severity and sleep quality in patients with knee osteoarthritis.

Methods: In this trial conducted in 2023, 126 patients were enrolled.

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Article Synopsis
  • A phase 3 study showed that combining camrelizumab with chemotherapy significantly improved progression-free survival in patients with advanced non-squamous non-small-cell lung cancer compared to chemotherapy alone.
  • After 5 years, overall survival rates were 31.2% for those receiving camrelizumab and chemotherapy versus 19.3% for those on chemotherapy alone, indicating a substantial benefit.
  • Patients who completed two years of treatment with camrelizumab had an impressive 5-year overall survival rate of 84.3%, reinforcing its effectiveness and safety as a first-line therapy for this cancer type.
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