Multiple issues surrounding the publication of clinical trials and the conduct of clinical trials, especially those that are industry-sponsored, have raised doubts regarding the integrity of their results, and of the integrity of the medical profession. An appreciation of the historical and economic changes in the relationship between physicians and industry is crucial to the understanding of these issues. Increasingly, as healthcare professionals and centers in the Asia-Pacific region become involved in corporate-funded multi-center drug trials, these ethical issues similarly come into play. It is imperative for medical leaders to take actions ensuring rights of subjects participating in these clinical trials, and to ensure the integrity of physicians and authors of clinical trials from this region of the world.
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http://dx.doi.org/10.1111/j.1756-185X.2009.01409.x | DOI Listing |
BAY 2413555 is a novel selective and reversible positive allosteric modulator of the type 2 muscarinic acetylcholine (M2) receptor, aimed at enhancing parasympathetic signaling and restoring cardiac autonomic balance for the treatment of heart failure (HF). This study tested the safety, tolerability and pharmacokinetics of this novel therapeutic option. REMOTE-HF was a multicenter, double-blind, randomized, placebo-controlled, phase Ib dose-titration study with two active arms.
View Article and Find Full Text PDFNat Commun
December 2024
Laboratory of Aging Research and Cancer Drug Target, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
The immune escape capacities of XBB variants necessitate the authorization of vaccines with these antigens. In this study, we produce three recombinant trimeric proteins from the RBD sequences of Delta, BA.5, and XBB.
View Article and Find Full Text PDFHere we report results of a phase 1 multi-institutional, open-label, dose-escalation trial (NCT02744287) of BPX-601, an investigational autologous PSCA-directed GoCAR-T® cell product containing an inducible MyD88/CD40 ON-switch responsive to the activating dimerizer rimiducid, in patients with metastatic pancreatic (mPDAC) or castration-resistant prostate cancer (mCRPC). Primary objectives were to evaluate safety and tolerability and determine the recommended phase 2 dose/schedule (RP2D). Secondary objectives included the assessment of efficacy and characterization of the pharmacokinetics of rimiducid.
View Article and Find Full Text PDFAndrology
December 2024
Interdisciplinary Department of Medicine, School of Medicine, University of Bari "Aldo Moro", Bari, Italy.
Background: Evidence indicates a wide range of andrological alterations in patients with the Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2) infection and Coronavirus Disease 2019 (COVID-19).
Aim: To provide an update on the andrological effects of SARS-CoV-2 infection and COVID-19.
Methods: PubMed/MEDLINE and Institutional websites were searched for randomized clinical trials, non-systematic reviews, systematic reviews, and meta-analyses.
Clin Physiol Funct Imaging
January 2025
Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation, Istanbul Okan University, Istanbul, Turkey.
Background: Delayed onset muscle soreness (DOMS) is a well-established phenomenon characterized by ultrastructural muscle damage that typically develops following unfamiliar or high-intensity exercise. DOMS manifests with a constellation of symptoms, including muscle tenderness, stiffness, edema, mechanical hyperalgesia, and a reduced range of joint motion. In recent years, the application of blood flow restriction (BFR) has garnered attention for its potential impact on DOMS.
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