Results 181 to 190 of about 71,128 (257)

Individualized clinical decisions within standard-of-care pragmatic clinical trials: Implications for consent. [PDF]

Clin Trials
Astrachan IM, Flory J, Kim SY.
europepmc   +1 more source

Prediction of Acute Liver Injury Trajectory in Patients Following Acetaminophen Overdose: A Multibiomarker Machine Learning Proof‐of‐Concept Study

Clinical Pharmacology &Therapeutics, EarlyView.
Clinical translation of novel therapies can be hindered by heterogeneity‐driven sample size inflation in late‐stage trials. In acetaminophen‐induced liver injury (APAP DILI), many patients recover spontaneously, diluting investigational drug efficacy signals.
Chris Humphries, Alastair M. Kilpatrick, Kathleen M. Scullion, Rhona Aird, Lorraine Bruce, Maria Elena Candela, Tak Yung Man, Stuart J. Forbes, James W. Dear   +8 more
wiley   +1 more source

Engaging clinical partners in pragmatic clinical trials: lessons learned from the pain management collaboratory. [PDF]

Pain Med
Bastian LA, Cohen SP, Salsbury SA, Davis AF, Katsovich L, Kerns RD.   +5 more
europepmc   +1 more source

Impact of CYP2C19 and CYP3A4 Inhibitor Use on Clopidogrel Clinical Effectiveness in CYP2C19 Genotyped Patients Undergoing Percutaneous Coronary Intervention

Clinical Pharmacology &Therapeutics, EarlyView.
CYP2C19 and CYP3A4 contribute to clopidogrel bioactivation. CYP2C19 no‐function alleles diminish clopidogrel's antiplatelet effects and clinical effectiveness. Coadministration of either a CYP2C19 or a CYP3A4 inhibitor may also reduce clopidogrel's antiplatelet effects and lead to phenoconversion in patients without a CYP2C19 no‐function allele (normal/
Danwei Shao, Jean G. Malavé, Joseph S. Rossi, Francesco Franchi, Ellen C. Keeley, Dominick J. Angiolillo, George A. Stouffer, Larisa H. Cavallari, Craig R. Lee   +8 more
wiley   +1 more source

Monitoring and reporting adverse events in pragmatic clinical trials testing nonpharmacological pain management interventions. [PDF]

Pain Med
Burns A, Young-McCaughan S, Davis AF, Vining R, Ali J, Fritz JM, Morasco BJ, Rhon DI, Roogow R, Kyriakides TC, Kerns RD.   +10 more
europepmc   +1 more source

Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke, Boitumelo Semete‐Makokotlela, Varnika Singh, Khanyisile Nkuku, Madelein Terblanche, Ezekiel T Mukanga, Nancy Ngum, Kudakwashe Dandajena, McNeil Chimus Mhango, Paulyne Wairimu, John Mwangi, Dominique Lagrave, Goonaseelan (Colin) Pillai   +12 more
wiley   +1 more source

Effectiveness of electronic medical record-based strategies for death and hospital admission endpoint capture in pragmatic clinical trials. [PDF]

J Am Med Inform Assoc
Rahafrooz M, Elbers DC, Gopal JR, Ren J, Chan NH, Yildirim C, Desai AS, Santos AA, Murray K, Havighurst T, Udell JA, Farkouh ME, Cooper L, Gaziano JM, Vardeny O, Mao L, Kim K, Gagnon DR, Solomon SD, Joseph J.   +19 more
europepmc   +1 more source

Preserved Spermatogenesis and Hormonal Function in Men Receiving a Pretomanid Regimen (BPaMZ) for Pulmonary Drug‐Resistant Tuberculosis

Clinical Pharmacology &Therapeutics, EarlyView.
Pretomanid is a component of the World Health Organization‐recommended treatment regimen for drug‐resistant tuberculosis in patients aged ≥ 14 years. While preclinical rodent studies identified testicular toxicity as a potential clinical liability at elevated doses, no corresponding effects were observed in nonhuman primates nor clinical hormone ...
Pauline Howell, Antonio Lombardi, William Brumskine, Lali Mikiashvili, Kim Boekelheide, Joanna Moreira, Alda Holsta, Matthew Betteridge, Lindsay Thompson, Angela Crook, Paul Bruinenberg, Maria Beumont, Eugene Sun, Francesca Conradie   +13 more
wiley   +1 more source

Use of Epic^® to facilitate high-quality randomization of emergency department-based pragmatic clinical trials. [PDF]

Clin Trials
Toerper MF, Haukoos J, Hopkins E, Rowan SE, Lyons MS, Galbraith JW, Hsieh YH, White DA, Levin S, Hinson J, Rothman RE, HIV TESTED and DETECT Hep C Trials Investigators.   +11 more
europepmc   +1 more source

Sustainability Assessment of Micro, Small, and Medium Enterprises: A Systematic Review and Hybrid Architecture for Credible, Salient, and Legitimate Knowledge Governance

Corporate Social Responsibility and Environmental Management, EarlyView.
ABSTRACT Sustainability assessment advances corporate social responsibility toward inclusive development. Widely recognized approaches prove inadequate for micro, small, and medium enterprises (MSMEs), resulting in fragmented proliferation that hinders cumulative knowledge.
Luísa Couto Gonçalves de Souza, Laura Proença Guimarães, Maria Auxiliadora Drumond   +2 more
wiley   +1 more source