Clinical therapeutics
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Clinical therapeutics · Aug 2019
Multicenter Study Observational StudyEffects of an Extract of Salmon Milt on Symptoms and Serum TNF and Substance P in Patients With Fibromyalgia Syndrome.
The aim of this study was to evaluate the effects of a dietary supplement containing primarily an extract of salmon's milt (semen) on symptoms and blood levels of proinflammatory molecules in patients with fibromyalgia syndrome (FMS), a chronic, painful musculoskeletal disease without a distinct pathogenesis or treatment. We recently reported increased serum levels of the proinflammatory molecules substance P (SP) and tumor necrosis factor (TNF) in patients with FMS as compared to those in normal controls. ⋯ Our findings indicate that this dietary supplement may significantly improve symptoms in patients with FMS. This is the first time to our knowledge that any molecule has been reported to be associated with a reduction in serum SP level. Consequently, the supplement or its hypothesized main active ingredient, spermine, may be developed as a novel treatment approach to FMS or other neuroinflammatory conditions. ClinicalTrials.gov identifier: NCT03911882.
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Clinical therapeutics · Aug 2019
A Study on the Application and Use of Artificial Intelligence to Support Drug Development.
The Tufts Center for the Study of Drug Development (CSDD) and the Drug Information Association (DIA) in collaboration with 8 pharmaceutical and biotechnology companies conducted a study examining the adoption and effect of artificial intelligence (AI), such as machine learning, on drug development. The study was conducted to clarify and understand AI adoption across the industry and to gather detailed insights into the spectrum of activities included in the definition of AI. The study investigated and identified analytical platforms and innovations across pharmaceutical and biotechnology companies currently being used or planned for in the future. ⋯ Despite the challenges to AI implementation, the survey revealed that most organizations use AI in some capacity and that it is important to the success of an organization's workforce. Many organizations reported expectations for increasing staff as implementation of AI expands. Further research should examine the changing development landscape as the role of AI evolves.
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Clinical therapeutics · May 2019
Randomized Controlled Trial Comparative StudyPharmacokinetics and Tolerability of Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate and Glycopyrronium/Formoterol Fumarate Dihydrate Metered Dose Inhalers in Healthy Chinese Adults: A Randomized, Double-blind, Parallel-group Study.
The objective of this study was to assess pharmacokinetic (PK) and safety profiles of 2 fixed-dose combinations in development for the treatment of chronic obstructive pulmonary disease (COPD): budesonide/glycopyrronium/formoterol fumarate dihydrate metered-dose inhaler (BGF MDI; triple combination) and glycopyrronium/formoterol fumarate dihydrate (GFF MDI; dual combination). The PK and safety profiles of BGF MDI and GFF MDI were assessed for the first time in healthy Chinese adults after single and repeated (7-day) dosing. ⋯ Overall, all treatments were well tolerated and PK parameters were generally comparable to those previously reported in Western and Japanese healthy subjects, suggesting that the doses of BGF MDI and GFF MDI in development globally for COPD are also appropriate for Chinese patients with COPD. ClinicalTrials.gov identifier: NCT03075267.
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Clinical therapeutics · May 2019
An Analysis of Time to Improvement in Oxygenation in Japanese Preterm and Late Preterm or Term Neonates With Hypoxic Respiratory Failure and Pulmonary Hypertension.
We analyzed data from an ongoing registry to determine time to improvement in oxygenation in preterm and late preterm or term neonates with hypoxic respiratory failure and pulmonary hypertension receiving inhaled nitric oxide (iNO) in Japan. ⋯ iNO treatment provided acute, sustained improvement in oxygenation in neonates with GAs <34 and ≥34 weeks; 70% of patients had improvement within 1 h, but the remaining 30% took >1 h to respond. Initiation of iNO at lower OIs was associated with reduced mortality compared with higher OI.
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Clinical therapeutics · Mar 2019
ReviewPreoperative Frailty Evaluation: A Promising Risk-stratification Tool in Older Adults Undergoing General Surgery.
General surgical procedures are among the most commonly performed operations in the United States. Despite advances in surgical and anesthetic techniques and perioperative care, complications after general surgery in older adults remain a significant cause of increased morbidity, mortality, and health care costs. Frailty, a geriatric syndrome characterized by multisystem physiologic decline and increased vulnerability to stressors and adverse clinical outcomes, has emerged as a plausible predictor of adverse outcomes after surgery in older patients. Thus, the goal of this topical review is to evaluate the evidence on the association between preoperative frailty and clinical outcomes after general surgery and whether frailty evaluation may have a role in surgical risk-stratification in vulnerable older patients. ⋯ Evidence supports the further development of preoperative frailty evaluation as a risk-stratification tool in older adults undergoing general surgery. Research is urgently needed to quantify and differentiate the predictive ability of validated frailty instruments in the context of different general surgical procedures and medical acuity and in conjunction with existing surgical risk indices widely used in clinical practice. Practical applicability of frailty instrument as well as geriatrics-centered outcomes need to be incorporated in future studies in this line of research. Furthermore, clinical care pathways that integrate frailty assessment, geriatric medicine focused perioperative and postoperative management, and patient-centered interdisciplinary care models should be investigated as a comprehensive intervention approach in older adults undergoing general surgery. Finally, early implementation of palliative care should occur at the outset of hospital encounter in frail older patients who present with indications for emergent general surgery.