Pragmatic Clinical Trials as Topic

Pragmatic Clinical Trial

Clinical Trials as Topic

Pharmacovigilance

Metacognitive therapy

LGBT psychology

Non-invasive cerebellar stimulation

Nathan Kuppermann

Hierarchical Taxonomy of Psychopathology

Effectiveness

Adult development

PubMed

Saul Kassin

Developmental language disorder

Scientific method

Bioethics

Amul Thapar

Index of contemporary philosophy articles

Panic disorder

Stepped-wedge trial

David J. Impastato

Ben Goldacre

Management of Tourette syndrome

Anorexia nervosa

Abductive reasoning

Helga Jónsdóttir

Science and technology in China

Communication disorder

Impact of the COVID-19 pandemic on children

Fibromyalgia

Non-alcoholic fatty liver disease

Learning health systems

Naloxone

Effectiveness15

• Many researchers are familiar with explanatory clinical trials, which look at the effectiveness of a particular intervention to improve health in a controlled setting. (nih.gov)
• Pragmatic trials are designed to evaluate the effectiveness of interventions in real-life routine practice conditions, whereas explanatory trials aim to test whether an intervention works under optimal situations. (nih.gov)
• Effectiveness is the extent to which a drug works under real world circumstances, i.e., clinical practice. (wikipedia.org)
• This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated multi-site clinical trials (e.g. efficacy, effectiveness or pragmatic trials) to study the effects of mind and body interventions in NCCIH designated areas of high research priority. (nih.gov)
• Methods and analysis: This is the protocol for a pragmatic, cluster-randomised stepped wedge trial to test the effectiveness of PRIM-ER in 35 EDs across the USA. (nyu.edu)
• These data provide essential information to design larger randomized controlled trials to test the effectiveness of these interventions. (elsevierpure.com)
• Effectiveness of a Nurse-Led Multidisciplinary Intervention vs Usual Care on Advance Care Planning for Vulnerable Older Adults in an Accountable Care Organization: A Randomized Clinical Trial. (wakehealth.edu)
• More than 4,000 VA medical providers participated in a pragmatic clinical trial designed to evaluate the effectiveness of two commonly used blood pressure medications. (va.gov)
• Such trials may have the potential to enhance the generalizability of findings, facilitate pragmatic study designs, and evaluate real-world effectiveness. (stanford.edu)
• Effectiveness of group arts therapies (art therapy, dance movement therapy and music therapy) compared to group counselling for diagnostically heterogeneous psychiatric community patients: study protocol for a randomised controlled trial in mental health services (the ERA study). (ox.ac.uk)
• Dr. Tunis was also a member of the Institute of Medicine Committee on Initial National Priorities for Comparative Effectiveness Research, which generated a widely used definition of the field and identified critical topics for research. (jhu.edu)
• The proposed trials should address critical decisional dilemmas that require important new evidence about the comparative clinical effectiveness of available interventions. (pcori.org)
• Through this PFA, PCORI is seeking to fund studies that address high-priority methodological gaps in patient-centered outcomes research (PCOR) and clinical comparative effectiveness research (CER). (pcori.org)
• However, controlled trials of the effectiveness of this approach in epiglottitis are limited. (medscape.com)
• A standardized method for identifying people with diabetes from the detailed clinical information available in electronic health records (EHRs), applied across multiple health systems, would be a powerful tool for conducting comparative effectiveness research, monitoring trends, analyzing geographic variation, and conducting surveillance of prediabetes and diabetes. (cdc.gov)

20234

• Oct 13 2023 This Week in Cardiology Three stories regarding GLP-1 agonists, imaging during PCI, and the power of sham controls in procedure trials are the topics John Mandrola, MD, covers in this week's podcast. (medscape.com)
• IHI will organize info days on call 3 from 12-15 December and call 4 from 18-19 January 2023, aimed at providing potential applicants with the information they need to understand the call topics and make new contacts to build a coherent consortium for their project proposals. (matical.com)
• Five topics will be launched in December 2022 (call 3, single stage) and 2 topics in January 2023 (call 4, two stage). (matical.com)
• The 2023 Broad Pragmatic Studies funding opportunities incorporates PCORI's National Priorities for Health and Board of Governors-approved Topic Themes. (pcori.org)

Outcomes9

• Often, the positive results from explanatory trials have been found to be less effective in practice than they were in the lab, because several factors not present in the controlled setting can affect the eventual outcomes. (nih.gov)
• Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions. (jameslindlibrary.org)
• At inclusion, written informed consent was requested for use of patient data, participation in patient-reported outcomes (PROs), and willingness to participate in (future) trials. (bvsalud.org)
• RWE is a broad area including clinical, economic, and patient reported outcomes, epidemiological and comparative setups, and various external stakeholders as well as the manufacturer's internal organization. (xtalks.com)
• The primary results of the Trauma Survivors Outcomes and Support ( TSOS ) trial, an NIH Collaboratory Demonstration Project , have been published. (nih.gov)
• The Ever-Evolving Landscape of Lipid-Lowering Therapies Drs Pam Taub and Steve Nissen discuss the current state of lipid management and what is on the horizon, thanks to the impact of highly anticipated clinical trial outcomes. (medscape.com)
• This discrepancy between clinical guidelines and real-world usage is possibly related to the belief that CTD has a greater risk of adverse effects without clear evidence for differences in cardiovascular outcomes. (va.gov)
• To incorporate understanding of psychosocial factors and key social determinants of health and their impact on health outcomes and disparities while conducting clinical care, research and advocacy. (cornell.edu)
• Further larger pragmatic studies would be valuable to determine whether bioimpedance to guide volume management improves patient-reported outcomes as well as long-term clinical outcomes in the high-risk hemodialysis population. (medscape.com)

Explanatory trials2

• These conditions are likely to exclude them from explanatory trials. (nih.gov)
• This review describes the concept of pragmatism, and explains in particular that there is a continuum between pragmatic and explanatory trials, rather than a dichotomy. (nih.gov)

Observational studies2

• In this webinar, we will focus on how RWD can be quickly applied to Observational Studies and Pragmatic Clinical Trials (PCTs), as well as what challenges researchers face in successful application of RWD to these studies. (brighttalk.com)
• Key Insights This webinar will discuss the advancements, opportunities, and challenges around the current and future use of Real-World Data from EHR systems in observational studies and pragmatic clinical trials. (brighttalk.com)

Practice9

• Pragmatic trials may test the same intervention as an explanatory trial, but they are conducted in real-world clinical practice settings, with typical patients and by qualified clinicians, who may not, however, have a research background. (nih.gov)
• Pragmatic trials are becoming increasingly popular because they're well suited for studies of how to get health services out into wider practice. (nih.gov)
• Pragmatic trials produce results that can be generalized and applied in routine practice settings. (nih.gov)
• Special focus is put on the limitations of the pragmatic trials, while recognizing the importance for and impact of this design on medical practice. (nih.gov)
• At a US practice, this randomised trial supplemented medical care with cognitive-behavioural therapy. (findings.org.uk)
• Episode 6: The Management of Melanoma in Community Oncology Practice Drs Patel, Wright, and Devoe revisit their involvement in the SWOG S1801 trial to highlight available resources that can expand the reach of cancer care in the community oncology setting. (medscape.com)
• Unmet Care Needs and Financial Hardship in Patients With Metastatic Non-Small-Cell Lung Cancer on Immunotherapy or Chemoimmunotherapy in Clinical Practice. (wakehealth.edu)
• Clinical trials provide the "gold standard" evidence for advancing the practice of medicine, even as they evolve to integrate real-world data sources. (stanford.edu)
• Implementing Genomics in Practice (IGNITE) Pragmatic Clinical Trials Network (PTN). (cdc.gov)

Generalizability of findings1

• Conclusions: Clinical trials can benefit from incorporating real-world data sources, potentially increasing the generalizability of findings and overall trial scale and efficiency. (bvsalud.org)

Participants6

• In pragmatic trials, though, researchers often relax eligibility requirements and accept participants with these conditions and control for it in their analysis. (nih.gov)
• Another feature of pragmatic trials is how participants are randomized to treatment and control groups. (nih.gov)
• In an explanatory trial, participants may be randomized in the order that they are recruited. (nih.gov)
• In pragmatic trials, participants are often randomized at the group level. (nih.gov)
• Participants undergoing phlebotomy were enrolled and randomized to a VR group or standard of care (SOC) group for this prospective pilot randomized, pragmatic study. (frontiersin.org)
• TRIAL DESIGN: Open-label, parallel, 1:1, phase 3, 2-arm randomized controlled trial PARTICIPANTS: The study population includes hospitalized adults admitted for COVID-19 prior to the development of critical illness. (ox.ac.uk)

Collaboratory6

• One relevant RFA ( RFA-RM-16-019 ) is using the NIH Common Fund's Health Care Systems Research Collaboratory, which currently coordinates the work of nine pragmatic trials. (nih.gov)
• The Collaborative Care for Chronic Pain in Primary Care ( PPACT ) study, an NIH Collaboratory Demonstration Project , published the primary results from their trial. (nih.gov)
• Primary results have been published of the Lumbar Imaging With Reporting of Epidemiology ( LIRE ) trial, an NIH Collaboratory Demonstration Project . (nih.gov)
• The primary results of the Pragmatic Trial of Video Education in Nursing Homes ( PROVEN ), an NIH Collaboratory Demonstration Project , have been published. (nih.gov)
• NIH Pragmatic Trials Collaboratory Grand Rounds: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (jhu.edu)
• Berman Institute faculty Stephanie Morain will participate in a special Grand Rounds series that the NIH Pragmatic Trials Collaboratory is launching this fall to examine ethical and regulatory challenges in pragmatic clinical trials. (jhu.edu)

Cluster randomized contr1

• TRAIN-AD - a cluster randomized controlled trial to evaluate a multicomponent intervention to improve infection management for suspected urinary and lower respiratory tract infections among advanced dementia residents in 24 Boston area nursing homes. (nih.gov)

Research21

• Using multiple health systems as the trial setting increases the likelihood that the results of the research can be widely applied. (nih.gov)
• Pragmatic trials are taking advantage of these settings and conducting research that is specific to the practitioners and patients involved in these complex systems. (nih.gov)
• Children's National, through research conducted by Children's Research Institute, the Sheikh Zayed Institute for Pediatric Surgical Innovation, and the Clinical and Translational Science Institute at Children's National, conducts and promotes translational and clinical medical research and education programs within Children's that lead to improved understanding, prevention, treatment, and care of childhood diseases. (childrensnational.org)
• This year, the American Association for Cancer Research (AACR) launched a series of Patient Advocate Forums , virtual conversations featuring leaders from patient advocacy, academia, industry, and health care discussing pressing topics and the latest discoveries in cancer research. (aacr.org)
• As scientific research has driven progress in cancer diagnosis and treatment, it has also led to significant changes in the way clinical trials are conducted. (aacr.org)
• Stuart McCully is an internationally recognized expert on NIS practices and country-specific submission processes, and the founder and owner of CHCUK Ltd, an on-line service specializing in non- interventional studies and clinical research compliance. (xtalks.com)
• Florian is based in Germany and consults on Late Stage and RWE topics such as defining the optimal study design for a research purpose, aligning operational strategy with the selected study design, and ensuring outcome validity. (xtalks.com)
• By taking this approach to research, it's possible to avoid one of the major pitfalls facing pharma today - the high cost of late-stage trial failure. (pmlive.com)
• As Vice President of Regulatory and Clinical Affairs, Paula was responsible for global regulatory leadership, clinical research, and clinical affairs. (citizencpr.org)
• Paula has held a variety of leadership positions since joining Physio-Control in 1985, including Vice President of Clinical Research and Clinical Affairs and Director of AED Product Development. (citizencpr.org)
• I have been a principal investigator of several research projects funded by the Duke Endowment and NIH, including an advance care planning (ACP) pragmatic randomized clinical trial, and have authored several key scientific publications related to this topic. (wakehealth.edu)
• Disclaimer: All research and clinical material published by Wake Forest University School of Medicine on its site is for informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider. (wakehealth.edu)
• Because of the number of Veterans VA cares for and our systemwide electronic medical record, we were able to embed this massive clinical trial within day-to-day care without any additional burden to the thousands of Veterans who volunteered for this study," said Rachel Ramoni, VA's chief research and development officer. (va.gov)
• Modern clinical trials are increasingly incorporating real-world data sources - data not intended for research and often collected in free-living contexts. (stanford.edu)
• In this position paper we aimed to provide guidance from the global clinical research network (Pediatric Inflammatory Bowel Disease Network, PIBDnet) for designing clinical trials in PIBD in order to facilitate drug approval for children. (bmj.com)
• Participation of stakeholders to help shape and inform clinical research design - i.e., participation of patients and caregivers, providers, payers, health technology assessors, and others - continues to be a central tenet of CMTP's commitment to changing health care for the better. (jhu.edu)
• Applicants also have the option to choose up to three Topic Themes based on how their proposed research aligns with the themes. (pcori.org)
• Due to the success of clinical trials in response to rehabilitating sensorimotor functions and cognition, more NICS research is being invested into. (wikipedia.org)
• This seminar will provide an overview of progress and ongoing challenges in genomic medicine in the last two decades and outlines research initiatives at the National Human Genome Research Institute that seek to advance the evaluation and implementation of new genome discoveries into clinical care and population health. (cdc.gov)
• The research funded by the division applies analytic technologies to clinical problems of disease diagnosis and treatment to enable melding clinical and genomic research for rapid improvements in clinical care. (cdc.gov)
• The Clinical Sequencing Evidence Generating Research (CSER) Consortium. (cdc.gov)

Efficacy2

• Clinical trial (or study) refers to an organised program to determine the safety and/or efficacy of a drug (or drugs) in patients. (wikipedia.org)
• Efficacy is the extent to which a drug works under ideal circumstances, i.e., in clinical trials. (wikipedia.org)

Interventions5

• Clinical trials have been the main tool used by the health sciences community to test and evaluate interventions, Trials can fall into two broad categories: pragmatic and explanatory. (nih.gov)
• There is a need for evidence-based, pragmatic interventions to improve functional recovery of older adults following acute hospitalization. (elsevierpure.com)
• Here, we report the results of a Phase I randomized clinical trial designed to determine safety and effect size of protein supplementation, exercise, and testosterone interventions on 30-day post-discharge functional recovery and readmissions in geriatric patients. (elsevierpure.com)
• Conclusions: Findings from this Phase I clinical trial suggest that pragmatic, evidence-based interventions may accelerate recovery from acute hospitalization in geriatric patients. (elsevierpure.com)
• It also provides a useful data source for pragmatic clinical trials of prevention or treatment interventions. (cdc.gov)

Conduct4

• Challenges in the conduct and interpretation of phase II (pilot) randomized trials. (jameslindlibrary.org)
• Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. (nih.gov)
• He has more than 20 years of experience in the conduct and management of Late Stage studies ranging from Phase IIIb/IV clinical trials to preference/opinion based studies. (xtalks.com)
• However, key differences in the design, conduct, and implementation of real-world vs traditional trials have ramifications in data management that can threaten their desired rigor. (bvsalud.org)

Patients24

• PROVEN - a cluster-randomized control trial of an advance care planning video program for nursing home patients in 359 facilities within two health care systems. (nih.gov)
• Phlebotomy procedures required in food allergy (FA) diagnosis and clinical trials often induce fear and anxiety for pediatric patients. (frontiersin.org)
• The primary aim of this study was to determine whether virtual reality (VR) applications were effective in reducing anxiety for pediatric FA patients undergoing phlebotomy during FA clinical trials. (frontiersin.org)
• Control group is a group (or cohort) of individual patients that is used as a standard of comparison within a clinical trial. (wikipedia.org)
• Stopping a trial early in oncology: for patients or for industry? (jameslindlibrary.org)
• More people are living through and beyond cancer thanks in large part to clinical trials, which have given countless cancer patients access to lifesaving treatments. (aacr.org)
• One key example is the I-SPY 2 trial, launched in 2010 as an "adaptive" clinical trial to test neoadjuvant treatments for high-risk breast cancer patients. (aacr.org)
• As genomic testing identified biomarkers in patients' tumors, the patients could be reassigned to different arms of the trial so that they could receive more effective treatments, explained Douglas Yee, MD, director of the Masonic Cancer Center at the University of Minnesota. (aacr.org)
• Current trials under the I-SPY umbrella investigate drug combinations, duration of treatment, and quality of life issues, adding valuable information to guide physicians in making the best decisions for their patients, Yee said. (aacr.org)
• In particular, the featured trial conducted at a US hospital's primary care centre investigated whether adding cognitive-behavioural therapy to medical care of patients prescribed Suboxone would further reduce illegal substance use and improve retention in treatment. (findings.org.uk)
• Patients were excluded from the trial if also dependent on alcohol, benzodiazepines or cocaine, or suffering from serious and/or dangerous forms of mental disturbance. (findings.org.uk)
• The 141 patients who started the trial were those left after 177 otherwise eligible patients did not progress to the randomisation phase of the trial, mostly because they lost contact or chose other treatments. (findings.org.uk)
• Typically patients left in the trial were white men in their early thirties and not in full-time employment. (findings.org.uk)
• Background: 'Trials-within-Cohorts' (TwiCs), previously known as 'cohort multiple randomized controlled trials' is a pragmatic trial design, supporting an efficient and representative recruitment of patients for (future) trials. (bvsalud.org)
• To our knowledge, the 'COhort for Lung cancer Outcome Reporting and trial inclusion' (COLOR) is the first TwiCs in lung cancer patients. (bvsalud.org)
• No Benefit to Extending Bevacizumab in Ovarian Cancer Maurie Markman, MD, discusses results from a pragmatic clinical trial regarding extended frontline treatment with bevacizumab in patients with ovarian cancer. (medscape.com)
• 16) enrollment in another clinical trial of antithrombotic therapy involving hospitalized patients. (ox.ac.uk)
• We also assign levels of certainty to the diagnosis of LM to provide guidance when to treat (as opposed to when to intensify diagnostic efforts) and on which patients to include in clinical trials. (eano.eu)
• Indeed, the clinical successes in several cancer types have generated widespread enthusiasm that immune-based treatments may influence the management of patients with malignant brain tumors as well. (escholarship.org)
• Together, these topics will provide a foundation for the exciting efforts in immune-based treatments that will hopefully provide real benefit to brain tumor patients. (escholarship.org)
• Il semble que l'insuffisance rénale aiguë (IRA) soit un syndrome idéal à partir duquel les différents aspects et applications mis en place pour gérer les mégadonnées pourraient influencer les modèles existants de prestation de services et d'offre de soins et, par extension, l'évolution de l'état de santé des patients. (biomedcentral.com)
• L'utilisation de formes novatrices pour assimiler les technologies et l'information a d'abord été identifiée en 2002 par l' Acute Dialysis Quality Initiative (ADQI) en tant que concept nécessitant une attention particulière et qui pourrait améliorer les soins et le pronostic des patients atteints d'IRA. (biomedcentral.com)
• In a randomized clinical trial of 156 hemodialysis patients, fluid management using BIA measures led to regression of left ventricular mass, decrease in blood pressure, and improvement in arterial stiffness. (medscape.com)
• Application of diagnostic tools such as BIS may be a novel approach to an established but challenging clinical problem of volume management in dialysis patients. (medscape.com)

Increasingly3

• Although the term 'pragmatic' has been used increasingly for such real life, randomized studies, it is not fully clear what pragmatic studies are, and for which purposes they should be performed: There are veils to lift around pragmatic studies, strategically as well as operationally. (xtalks.com)
• This webinar describes and explains pragmatic studies and discusses why key Late Stage stakeholders are increasingly interested in pragmatic studies - and why, nevertheless, pragmatic approaches are still relatively rare in the area of RWE. (xtalks.com)
• Wearables and other mobile technologies are increasingly recognised as drivers of democratisation and diversification in clinical trials. (iconplc.com)

Evaluate2

• Shed MEDS - a randomized controlled trial to evaluate the effects of an intervention to reduce medication use among hospitalized older adults discharged to skilled nursing facilities. (nih.gov)
• The objective of this randomized controlled trial was to evaluate oral health effects of single-visit, non-surgical periodontal therapy compared to no treatment. (who.int)

Findings3

• Presents findings from a test of the Million Hearts model for CMS through a large, randomized trial, including hundreds of thousands of beneficiaries across the United States of the Million Hearts model from 2017 to 2021. (rand.org)
• False-positive findings in Cochrane meta-analyses with and without application of trial sequential analysis: an empirical review. (jameslindlibrary.org)
• Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomised trials? (jameslindlibrary.org)

Study11

• Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study. (jameslindlibrary.org)
• study is a feasibility pilot study to help us get information to design a larger trial of diuretic management for bronchopulmonary dysplasia. (nih.gov)
• This study is located at the NIH Clinical Center in Bethesda, Maryland. (nih.gov)
• Agencies thus look to combine real world data collection with control of treatment allocation bias, preferably by study designs including subject based randomization i.e., pragmatic studies. (xtalks.com)
• The panel outlines operational modifications and adaptations of the main pragmatic study approach, such as community based studies, cluster randomized approaches, and 'stepped wedge' designs. (xtalks.com)
• An outlook into the future of pragmatic study types will be provided, and strategic options for potential design modifications will be assessed. (xtalks.com)
• The study was a first-of-its-kind pragmatic trial that was embedded in usual clinical care. (va.gov)
• Also, all study procedures were done as part of routine clinical care. (va.gov)
• RAPID Trial): A structured summary of a study protocol for a randomised controlled trial. (ox.ac.uk)
• This prepublication history comprises all previous versions of the manuscript, the study protocol (submitting the protocol is mandatory for all clinical trials and encouraged for all other studies at The BMJ ), the report from the manuscript committee meeting, the reviewers' comments, and the authors' responses to all the comments from reviewers and editors. (bmj.com)
• However, the use of an invasive procedure limited the clinical application and relevance of the study. (wikipedia.org)

Ethical2

• Conclusion The viewpoints expressed in this paper could assist planning clinical trials in PIBD which are both of high quality and ethical, while remaining pragmatic. (bmj.com)
• Download the Ethical and Regulatory Dimensions of Pragmatic Trials series flyer and see the schedule below. (jhu.edu)

Practices3

• In addition to testing a particular intervention, pragmatic trials can also illustrate the differences in how the intervention works in different health care settings, such as hospitals, clinics, or physician practices. (nih.gov)
• Media article: Will COVID-19 bring lasting change in clinical trial practices? (iconplc.com)
• COVID-19 may be the inflection point that tips clinical trial practices into the digital age. (iconplc.com)

Informatics2

• Oversight will also be provided by the National Institutes of Health, an Independent Monitoring Committee and a Clinical Informatics Advisory Board. (nyu.edu)
• I have a interest in implementation science, clinical informatics, and pragmatic clinical trial design. (wakehealth.edu)

Design4

• Since most results from exploratory trials fail to be broadly generalizable, the "pragmatic design" has gained momentum. (nih.gov)
• The design of a clinical trial will depend on the drug and the phase of its development. (wikipedia.org)
• In recent years, these high stakes have been somewhat mitigated by trial design that encompasses multiple endpoints and often, multiple sponsors and participating cancer centers. (aacr.org)
• Introduction The optimal trial design for assessing novel therapies in paediatric IBD (PIBD) is a subject of intense ongoing global discussions and debate among the different stakeholders. (bmj.com)

Methods8

• Comparison of four methods of allocation for clinical trials with small sample sizes. (jameslindlibrary.org)
• We will close our evaluation of pragmatic studies and their nuances by assessing evidence validity from pragmatic approaches with others, primarily analytic methods minimizing bias in observational settings. (xtalks.com)
• Understand analytic considerations for evidence validity in pragmatic designs, versus non-interventional approaches using analytic techniques such as regression methods, propensity score matching, instrumental variables. (xtalks.com)
• METHODS: A pragmatic multi-centre 2-arm randomised controlled superiority trial with health economic evaluation and nested process evaluation. (ox.ac.uk)
• Methods A writing group has been established by PIBDnet and topics were assigned to different members. (bmj.com)
• Methods: Three examples of real-world trials that leverage different types of data sources - wearables, medical devices, and electronic health records are described. (bvsalud.org)
• METHODS: In a single-center trial spanning Delta and Omicron variants, outpatients were randomized to 100 mg/d of oral acebilustat or placebo for 28 days. (bvsalud.org)
• METHODS: We conducted a phase 2, double-blind, randomized controlled outpatient trial of favipiravir in asymptomatic or mildly symptomatic adults with a positive SARS-CoV-2 reverse-transcription polymerase chain reaction assay (RT-PCR) within 72â hours of enrollment. (bvsalud.org)

Therapy2

• For this 15th ADQI consensus meeting held on September 6-8, 2015 in Banff, Canada, five topics focused on AKI and acute renal replacement therapy were developed where extensive applications for use of big data were recognized and/or foreseen. (biomedcentral.com)
• BACKGROUND: Simplified periodontal therapy might be a pragmatic strategy for public health programmes targeting Indigenous Australian adults. (who.int)

Genomics2

• Hot Topics of the Day are picked by experts to capture the latest information and publications on public health genomics and precision health for various diseases and health topics. (cdc.gov)
• Articles listed in Hot Topics of the Day are selected by the CDC Office of Genomics and Precision Public Health to provide current awareness of the scientific literature and news. (cdc.gov)

Health9

• Marcel SALIVE , Health Scientist Administrator, Division of Geriatrics and Clinical Gerontology (DGCG) . (nih.gov)
• Clinical data, data on lifestyle factors and health-related quality of life (HR-QoL) and blood samples will be collected at baseline, 6 months, 12 months and 24 months. (nih.gov)
• Digital health has been a hot topic for many years, but it has taken the pandemic to really highlight its value across many areas of the pharma and biotech industries. (iconplc.com)
• They can be incorporated into the clinical workflow of providers by leveraging the electronic health record and other existing infrastructure. (va.gov)
• La antigua IMI ( Innovative Medicines Initiative ) se convierte en IHI ( Innovative Health Initiative ). (matical.com)
• Dr. Tunis has served as the company's CEO since its founding in 2008 and established the company's mission to improve clinical evidence for health care delivery and health policy decisions. (jhu.edu)
• Much of Dr. Tunis's past career has been focused on strategies to improve the quality and relevance of evidence available to inform clinical and health policy decisions. (jhu.edu)
• Title : Pragmatic Applications of RE-AIM for Health Care Initiatives in Community and Clinical Settings Personal Author(s) : Glasgow, Russell E.;Estabrooks, Paul E. (cdc.gov)
• For many years, diabetes registries have been used to assess and enhance clinical care provided by health systems (1). (cdc.gov)

Centers3

• Clinical Coordinating Centers should develop and implement the proposed multi-site clinical trial. (nih.gov)
• The trial is a collaboration between the National Cancer Institute (NCI) and cancer centers across the country, allowing for a large scope and a diverse patient population. (aacr.org)
• The Diuretic Comparison Project ( CSP 597 ) is a large pragmatic clinical trial that was conducted at 537 VA medical centers and community clinics in the U.S. The trial enrolled more than 4,000 providers and 13,500 Veterans with high blood pressure who were taking HCTZ at baseline. (va.gov)

Past decade1

• Panelists discussed how clinical trials have changed over the past decade, evolving to become more flexible, pragmatic, and patient-centered. (aacr.org)

Acute2

• Citation bias favoring positive clinical trials of thrombolytics for acute ischemic stroke: a cross-sectional analysis. (jameslindlibrary.org)
• Introduction: Emergency departments (ED) care for society's most vulnerable older adults who present with exacerbations of chronic disease at the end of life, yet the clinical paradigm focuses on treatment of acute pathologies. (nyu.edu)

Operationally1

• This trial has shown that large, embedded trials are operationally feasible. (va.gov)

Participation4

• Pragmatic trials also seem likely to allow greater participation of older adults. (nih.gov)
• Additionally, needle phobia may contribute to reluctance toward routine diagnostic testing and participation in FA trials that require phlebotomy. (frontiersin.org)
• Among these, 127 (75%) gave informed consent to PROs participation and 110 (65%) were willing to participate in (future) trials. (bvsalud.org)
• As part of VA's clinical trials enterprise, it allowed participation from across the country with no additional staff. (va.gov)

Webinar1

• For each of the upcoming topics in Call 3 and 4 a webinar is provided, followed by matchmaking opportunities and pitching sessions. (matical.com)

Adverse events1

• GESTIÓN EN SALUD PÚBLICA: The INGENIOUS trial: Impact of pharmacogenetic testing on adverse events in a pragmatic clinical trial. (blogspot.com)

Results4

• Trial results will be submitted for publication in a peer-reviewed journal. (nyu.edu)
• Results The commentary includes 18 statements for guiding data extrapolation from adults, eligibility criteria to PIBD trials, use of placebo, dosing, endpoints and recommendations for feasible trials. (bmj.com)
• There is not yet sufficient evidence of the therapeutic effects of cerebellar TMS, although some successful results have been reported in other clinical studies of TMS used to treat the frontal lobe. (wikipedia.org)
• The more recent availability of detailed clinical data, including real-time laboratory test results, has improved the ability to build more sophisticated and accurate diabetes registries that capture more precisely defined cohorts of people with diabetes. (cdc.gov)

Drug's1

• Barker explained that in a single-arm clinical trial, a drug's failure to meet its endpoints and progress to the next phase caused steep financial costs for the drugmakers without leading to patient benefit. (aacr.org)

Treatment6

• Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis. (jameslindlibrary.org)
• These EANO-ESMO joint recommendations for the diagnosis and treatment of leptomeningeal metastasis (LM) from solid cancers represent the first European guideline initiative on this topic. (eano.eu)
• We propose diagnostic criteria as well as a neuroimaging- and cytopathology-based classification of LM syndromes to derive pragmatic treatment algorithms. (eano.eu)
• Conclusion Non-antibiotic prophylactic treatment with methenamine hippurate might be appropriate for women with a history of recurrent episodes of urinary tract infections, informed by patient preferences and antibiotic stewardship initiatives, given the demonstration of non-inferiority to daily antibiotic prophylaxis seen in this trial. (bmj.com)
• NICS has the potential to attack multiple neurological and psychiatric disorders, although NICS are still not included and heavily advocated in clinical treatment. (wikipedia.org)
• Endpoints were summary variables derived from clinical assessments of probing depth, clinical attachment loss, plaque, calculus and gingival bleeding before treatment and 3 months later. (who.int)

Pharmacogenetic1

• The objective of this INGENIOUS trial (NCT02297126) analysis was to determine whether conducting and reporting pharmacogenetic panel testing impacts ADE frequency. (cdc.gov)

Real-world trials1

• We refer to trials that incorporate real-world data sources as real-world trials. (stanford.edu)

Regulatory considerations1

• The panel also discusses both current and future regulatory considerations such as the new EU Clinical Trials Regulation. (xtalks.com)

Studies5

• NIA recently joined with other NIH Institutes to fund studies using a pragmatic clinical trial approach. (nih.gov)
• You can also view the complete list of NHLBI-funded studies at ClinicalTrials.gov . (nih.gov)
• Particularly when we have high failure rates in late stages in clinical studies, it's very, very expensive," he says. (pmlive.com)
• Studies on the clinical relevance of NTM have traditionally been restricted to western countries, where the incidence of TB is relatively low. (cdc.gov)
• View a selection of high-priority conditions and topics that our funded studies and projects address. (pcori.org)

Data6

• In addition, an accompanying Data Coordinating Center application, submitted under PAR-17-173 proposing a data analysis and data management plan for the clinical project is required. (nih.gov)
• Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. (nih.gov)
• The evolving role of data & safety monitoring boards for real-world clinical trials. (stanford.edu)
• Technological innovations have enabled many of our day-to-day activities to be "data-fied" and leave unique and discrete digital traces, from personal (i.e., web searching, wearing a smart watch) to professional tasks (i.e., use of electronic clinical information systems or medical records). (biomedcentral.com)
• Key insights applicable to all three trials in their relationship to Data and Safety Monitoring Boards (DSMBs) are derived. (bvsalud.org)
• The nature of monitoring the data and safety must evolve to adapt to new trial scenarios to protect the rigor of clinical trials. (bvsalud.org)

Researchers1

• Acknowledging the first point, Dr Weir notes that understanding what a patient goes through can inspire researchers who may be 15 years away from their work being translated into something that can be used for clinical benefit. (pmlive.com)

Intervention1

• This study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. (nih.gov)

Diagnosis1

• Trials to date have been limited to one art-form or diagnosis. (ox.ac.uk)