• and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. (nih.gov)
  • Objective To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity. (bmj.com)
  • Surrogate outcomes may seem an attractive alternative to clinically relevant outcomes in clinical trials. (bmj.com)
  • 5 However, even trials with thoroughly validated surrogates cannot match trials with clinical outcomes, as some uncertainty will always remain. (bmj.com)
  • Clinicians, and particularly pharmaceutical companies, often do not distinguish clearly between surrogate and clinical outcomes. (bmj.com)
  • Targeted pre-post analyses will also examine specific outcomes appropriate to the topics selected for intervention. (cdc.gov)
  • Process evaluation outcomes include fidelity of the HWPP intervention, extent of individual DT member activity, expansion of committee scope to include employee well-being , program obstacles and opportunities in each setting, and sustainability (within the available time frame). (cdc.gov)
  • 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)
  • Clinical significance Proper emergence profile design supports esthetic outcomes and provides favorable biological response to implant‐supported restorations. (researchgate.net)
  • Concealing results or selectively reporting outcomes of a clinical trial can directly influence the care of patients. (cmaj.ca)
  • This entry is our analysis of a study considered particularly relevant to improving outcomes from drug or alcohol interventions in the UK. (findings.org.uk)
  • Each intervention type showed effectiveness on 1-6 outcomes. (cdc.gov)
  • The research methodologies best development in the department are epidemiology (in the broadest sense), clinical research and translational research, especially in immunology and oncology. (erasmusmc.nl)
  • As usual, there was a vast array of PD research presented, covering topics that included clinical trials, epidemiology, non-pharmacologic interventions, non-motor symptoms, neuroimaging, gene- and cell-based therapies and more. (apdaparkinson.org)
  • Journal of clinical epidemiology , 117, 126-137 doi:10.1016/j.jclinepi.2019.10.002. (irb.hr)
  • The chapter aptly titled "Humanity's Biggest Killer" outlines the history, epidemiology, and clinical manifestations of mosquitoborne diseases. (cdc.gov)
  • Systematic studies on the efficacy of prevention methods for problematic pornography use are still missing, but a very important topic for future research and practice. (thieme-connect.com)
  • Systematic studies addressing potential intervention strategies are one of the main challenges for future research providing data for evidence-based prevention and treatment of pornography-use disorder. (thieme-connect.com)
  • The USPSTF has made recommendations on screening for obesity in adults, screening for gestational diabetes mellitus, and behavioral counseling interventions to promote a healthy diet and physical activity for cardiovascular disease prevention in adults with and without cardiovascular risk factors. (uspreventiveservicestaskforce.org)
  • Designing an intervention to prevent suicide: PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial). (athealth.com)
  • I have lead clinical studies of blood thinners and coronary intervention for heart attacks, stroke prevention in atrial fibrillation, and prevention of heart attack for patients with coronary artery disease. (duke.edu)
  • Palliative[[According to WHO, palliative care is ""an approach that improves the quality of life of patients and their families facing the problem associated with life threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual"" ( http://www.who.int/cancer/palliative/definition/en/ ). (europa.eu)
  • In 2006, for example, a case study of the quality of reporting of systematic reviews found that 10 separate reviews on the role of acetylcysteine in the prevention of contrast-associated nephropathy published between 2003 and 2005 were identified 5 and at least 5 more reviews on this topic have been published subsequently. (cmaj.ca)
  • Supports the translation of promising preclinical findings into clinical applications for prevention, detection, diagnosis, treatment, and/or quality of life - Letter of Intent deadline is April 29, 2022 5:00 p.m. (curefa.org)
  • Further review of the data presented, and potentially additional analyses, will be needed to develop clinical guidance on the safe and effective use of this strategy for bacterial STI prevention among gay and bisexual men and transgender women. (cdc.gov)
  • LMICs in the context of cancer control, in the number of doses for more effectiveness of cancer prevention and conducts clinical and screening trials, affordable and logistically feasible pro- early detection interventions to guide and conducts implementation and health grammes. (who.int)
  • BACKGROUND: This article summarizes the results from systematic reviews of human immunodeficiency virus (HIV) prevention interventions for people who use drugs (PWUD). (cdc.gov)
  • METHODS: We conducted a comprehensive systematic literature search using the Centers for Disease Control and Prevention HIV/AIDS Prevention Research Synthesis Project database to identify quantitative systematic reviews of HIV public heath interventions with PWUD published during 2002-2017. (cdc.gov)
  • Therefore results from trials based on surrogates can be difficult for doctors to apply in clinical practice. (bmj.com)
  • Furthermore, readers will want to know if the surrogate has been validated and is sufficiently reliable to warrant changes in clinical practice, provided the harms of the treatment are acceptable. (bmj.com)
  • Clinical practice guideline, number 5. (athealth.com)
  • The interventions proposed under this FOA should have the potential to be widely disseminated to clinical practice, individuals and communities at risk. (nih.gov)
  • Medscape's Topics in Advanced Practice Nursing eJournal is a peer-reviewed, exclusively electronic journal aimed at advanced practice nurses, specialty nurses, and other healthcare providers. (medscape.com)
  • Our focus is on innovative healthcare programs, novel research applications, and comprehensive reviews, all with recommendations for clinical practice. (medscape.com)
  • 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)
  • One group of participants treated in a setting such as a hospital, nursing home, clinic, or physician's practice, might receive the intervention, while people matched to be treated in a similar setting might serve as the control group. (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)
  • We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines. (biomedcentral.com)
  • The oversight of clinical trials aims to safeguard study participants, and ensure that trials are run in accordance with Good Clinical Practice (GCP), and trial data are of high calibre (i.e. reliable) and collected in a reasonable timeframe. (biomedcentral.com)
  • In the United Kingdom (UK), the Medical Research Council (MRC) guidelines for Good Clinical Practice (1998) define a three-committee trial oversight structure for MRC trials and this approach has been broadly adopted in the UK [ 1 ]. (biomedcentral.com)
  • Further improvements in ClinicalTrials.gov registration requirements, including phase 1 trials, and more stringent publishing requirements for essential data on drug interventions, are needed to prevent patient risk in clinical practice regarding concomitant medication use. (irb.hr)
  • At a US practice, this randomised trial supplemented medical care with cognitive-behavioural therapy. (findings.org.uk)
  • Clinical validation should include prospective validation of the biomarker or biomarker signature and if validated, may be used to stratify patient populations for therapeutic testing or for making treatment decisions in clinical practice. (nih.gov)
  • Randomized control ed trials form the foundation for "evidence-based medicine", but such research can be relied upon only if it is conducted according to principles and standards col ec- tively referred to as "Good Clinical Research Practice" (GCP). (who.int)
  • This handbook is issued as an adjunct to WHO's "Guidelines for good clinical practice (GCP) for trials on pharmaceutical products" (1995), and is intended to assist national regulatory authorities, sponsors, investigators and ethics committees in implementing GCP for industry- sponsored, government-sponsored, institution-sponsored, or inves- tigator-initiated clinical research. (who.int)
  • Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientifi c quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects. (who.int)
  • Common sense and clinical observation fail for several reasons: incomplete understanding of pathophysiology, biases and unmeasured confounding in observational research, and failure to understand risks and benefits of treatments within complex systems. (duke.edu)
  • He is the Director of Cardiovascular Research at the Duke Clinical Research Institute where he oversees a large group of clinical research faculty and a broad portfolio of cardiovascular clinical trials and observational clinical research programs. (duke.edu)
  • Randomised clinical trials or observational studies of new or improved patient and/or family centred[[Involving patients and their caregivers (families, volunteers, nurses and others), and taking their views and values into account in care decisions. (europa.eu)
  • STUDY DESIGN AND SETTING: Observational study of completed interventional trials on DDIs with up to two drugs within the Intervention registration element in ClinicalTrials.gov until October 2015. (irb.hr)
  • Sixty participants purposefully selected will complete a semi-structured interview following the 6-month intervention. (nih.gov)
  • Participants Randomised clinical trials published in 2005 and 2006 that used a surrogate as a primary outcome. (bmj.com)
  • Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p = 0.01). (biomedcentral.com)
  • Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome) or 2,000 participants (categorical outcome). (biomedcentral.com)
  • 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 described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor and funder. (biomedcentral.com)
  • Participants will be screened for risk factors related to four modules that comprise the MYB intervention: physical activity, nutrition, mental health, and cognitive training. (mcmaster.ca)
  • Targeting risk factors will enable interventions to be personalized so that participants receive the most appropriate modules. (mcmaster.ca)
  • Upon completing a module, participants will continue to receive less frequent booster activities for their eligible modules (except for the mental health module) until the end of the trial. (mcmaster.ca)
  • Extrapolating from a rate of nonpublication for systematic reviews of 12.4%, 4 one estimate suggests that the contributions to clinical research of about a third of a million participants annually might be unused in a systematic review. (cmaj.ca)
  • With fewer than 100 participants, the size of the average randomized trial is small, 8 whereas systematic reviews are comparatively large. (cmaj.ca)
  • Support trials that minimize participant travel to the Twin Cities with most of the interactions with research participants occurring in their own home clinic, a nearby clinic or hospital, or virtually. (umn.edu)
  • The study offers equitable opportunities for eligible participants within the existing clinical population of the host site(s). (umn.edu)
  • Indexing policy: Use for the original report of the conduct or results of a specific randomized veterinary clinical trial in which animal participants are randomly assigned to receive one or more interventions. (bvsalud.org)
  • In late September, at a WHO consultation on Ebola vaccines, participants agreed to a clinical regulatory pathway for the rapid evaluation of vaccines for safety, immunogenicity, and efficacy. (who.int)
  • Approximately 50 participants from each health facility will be enrolled on the trial. (lu.se)
  • Participants in facilities randomised to the intervention arms are offered a DAT linked to the ASCENT adherence platform for daily adherence monitoring and differentiated response for those who have missed doses. (lu.se)
  • Supports research that will make an original and important contribution to the field of research or patient care in the Topic Area(s) of interest - Letter of Intent deadline is April 29, 2022 5:00 p.m. (curefa.org)
  • Which treatments and interventions will help? (nih.gov)
  • Such discrepancies can lead to implementation of harmful treatments or to exclusion of beneficial interventions. (bmj.com)
  • A clinical trial is a study using people who agree to participate in new tests or treatments. (medlineplus.gov)
  • Current cancer medicines, tests, and treatments used by most health care providers have been tested through clinical trials. (medlineplus.gov)
  • Proposals should demonstrate, the effectiveness and cost-effectiveness of new, improved or specifically adapted pharmacological and/or non-pharmacological interventions to either relieve symptoms (e.g. pain) and suffering caused by life-threatening non-communicable diseases (including disabilities), or serious late and long-term side effects of disease treatments in patients and survivors, or symptoms that occur at the end of life. (europa.eu)
  • Improved clinical guidelines and policy recommendations with respect to pain management, palliative, end-of-life or survivorship care of patients with life-threatening non-communicable diseases or afflicted by late and long term side-effects of treatments. (europa.eu)
  • 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)
  • Much of what is known today about the safety and effi cacy of specifi c prod- ucts and treatments has come from randomized control ed clinical trials1 that are designed to answer important scientifi c and health care questions. (who.int)
  • During the first meeting, ethicists and scientific experts concluded that it would be acceptable to offer to EVD patients as potential treatments unregistered interventions that have shown promising results in the laboratory and in animal models, but have not yet been evaluated for safety and efficacy in humans. (who.int)
  • The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. (bmj.com)
  • Case reports and proof-of-concept studies suggest the efficacy of pharmacological interventions, for example the opioid antagonist naltrexone, for treating individuals with pornography-use disorder and compulsive sexual behavior disorder. (thieme-connect.com)
  • Randomized placebo-controlled clinical trials are needed to demonstrate the potential long-term effects of pharmacological interventions. (thieme-connect.com)
  • The efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. (biomedcentral.com)
  • The DT conducts root cause analyses, prioritizes problems, identifies feasible interventions in light of the constraints and needs of the specific setting, makes business-case presentations to facility leadership, and assists in evaluation. (cdc.gov)
  • Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible. (biomedcentral.com)
  • The study is the first randomized clinical trial to examine efficacy of a disease-modifying therapy in delaying symptoms in RIS. (medscape.com)
  • Member states should expand the scope of the proposed agreement to address such topics as additional funding for research on the development (R&D) of new antibiotic drugs, better low-cost diagnostics, basic research in areas of particular interest to all member states, and the funding to independent clinical trials to evaluate the efficacy of pharmaceutical drugs. (haiweb.org)
  • The approach she adopted for curriculum development is an evidence-supported curriculum-design process through which a curriculum is put to the rigorous process of intervention research to determine its efficacy. (humankinetics.com)
  • Funding agencies such as the United Kingdom Medical Research Council and the Canadian Institutes of Health Research require systematic reviews as part of the rationale to fund randomized trials. (cmaj.ca)
  • Nevertheless, we question whether this many systematic reviews on a single topic are necessary. (cmaj.ca)
  • A registry of systematic reviews differs in purpose and importance from a registry of clinical trials. (cmaj.ca)
  • Preferred Reporting Items for Systematic Reviews and Meta-Analyses), STARD (Standards for Reporting of Diagnostic Accuracy), COREQ (Consolidated criteria for reporting qualitative research), CARE (guideline for clinical case report), and the COCHRANE handbook (for systematic reviews of interventions). (who.int)
  • NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. (nih.gov)
  • This FOA supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. (nih.gov)
  • We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. (nih.gov)
  • ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. (nih.gov)
  • We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. (nih.gov)
  • 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)
  • 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)
  • A strong foundation in clinical trials helps prepare scientists to evaluate published medical advances and to implement well-designed pioneering health research. (umn.edu)
  • OBJECTIVES: The aim of the study was to evaluate the completeness of intervention description in ClinicalTrials.gov and corresponding journal articles for registered and published drug-drug interaction (DDI) trials because complete and transparent description of interventions is particularly important for DDI. (irb.hr)
  • OBJECTIVE: We aim to evaluate the effects of kinesiotherapy with exergaming on older women's epigenetic marks and cognitive ability, as well as on their clinical functional variables. (bvsalud.org)
  • Section develops educational materials mized clinical trials to evaluate the income countries (LMICs). (who.int)
  • This program ensured the inclusion of the topic of 'patient safety' in the curriculum of health undergraduate courses ( 5 ) , but did not specify the mechanisms that should be used to evaluate the insertion of this subject. (bvs.br)
  • Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research. (ahrq.gov)
  • Four grant announcements, sharing a single title, "Research to Address the Heterogeneity in Autism Spectrum Disorders," will use different funding mechanisms to support a range of research topics over the next two years. (nih.gov)
  • While few trials can be completed in two years, ARRA funds will be important for jumpstarting projects and building the infrastructure or foundation for longer-term autism research efforts. (nih.gov)
  • These topics correspond directly to short-term research objectives detailed in the Interagency Autism Coordinating Committee's (IACC's) Strategic Plan for Autism Spectrum Disorder Research ( http://iacc.hhs.gov/reports/2009/iacc-strategic-plan-for-autism-spectrum-disorder-research-jan26.shtml ), released earlier this month. (nih.gov)
  • The Medical Research Councils' framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. (nih.gov)
  • For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. (nih.gov)
  • His research on venous hemodynamics has led to the discovery that increasing venous blood flow through exercise interventions can accelerate thrombus resolution and prevent chronic post-thrombotic syndrome in patients with acute deep vein thrombosis (DVT). (wikipedia.org)
  • The Seniors Health and Activity Research Program Pilot trial (SHARP-P) was designed to serve these purposes for trials assessing cognitive and physical activity training. (biomedcentral.com)
  • Over the three years that these are open, NIA will issue other related notices describing high-priority research topics that fall within the purview of the parents. (nih.gov)
  • Our research includes clinical, epidemiological, cost-effectiveness, qualitative and translational research to detect conditions at early stages, improve treatment and prognosis, and change public health policies. (erasmusmc.nl)
  • John H. Alexander, MD, MHS is a cardiologist and Professor of Medicine in the Department of Medicine, Division of Cardiology at Duke University School of Medicine, as well as the Vice Chief, Clinical Research in the Division of Cardiology. (duke.edu)
  • Research: My primary research interest is in conduct and methodology of large randomized clinical trials in heart disease. (duke.edu)
  • 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)
  • 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)
  • We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines. (biomedcentral.com)
  • CTUs employ staff with expertise in trial design, trial coordination and statistics, and sometimes in qualitative research and health economics, who support trials through to completion. (biomedcentral.com)
  • It really supports the concept of the benefit of early treatment intervention within this given MS disease spectrum," lead investigator Darin Okuda, MD, professor of neurology at The University of Texas Southwestern Medical Center in Dallas, told delegates attending the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Amsterdam. (medscape.com)
  • Graduate students are often encouraged to complete a systematic review as part of their thesis and clinical trainees often perform such reviews during research-related elective courses. (cmaj.ca)
  • 6 Given that many organizations need reviews on the same topics (such as assessment of medications and technologies), avoiding unnecessary duplication would free resources from these agencies to tackle other topics of research. (cmaj.ca)
  • One in five people who have had chickenpox will get shingles later in life, usually after age 50, and the risk increases as people get older," says NIA Director Richard J. Hodes, M.D. "More research is needed, but this study suggests that the Tai Chi intervention tested, in combination with immunization, may enhance protection of older adults from this painful condition. (science20.com)
  • Dr. Irwin's research team has demonstrated that a centuries-old behavioral intervention, Tai Chi, resulted in a level of immune response similar to that of a modern biological intervention, the varicella vaccine, and that Tai Chi boosted the positive effects of the vaccine," says Andrew Monjan, Ph.D., chief of the NIA's Neurobiology of Aging Branch. (science20.com)
  • This study builds upon preliminary research funded by NCCAM and we are delighted to see this rigorous trial of Tai Chi for varicella zoster immunity come to fruition," said Ruth L. Kirschstein, M.D., NCCAM Acting Director. (science20.com)
  • In this article the authors reflect on the experiences they had with her in these curriculum interventions, share the ideas and practices in the research as Ennis envisioned, and discuss challenges and solutions in conducting large-scale, school-based curriculum intervention studies. (humankinetics.com)
  • Build on rural Minnesotans' access to a wide range of human participant research trials by expanding sustained relationships with physicians, clinics, and hospitals in greater Minnesota and ensuring the resources are in place to support that work. (umn.edu)
  • There is not another departmental resource or existing infrastructure that may be a better fit to take on the project (e.g., another clinical trial network with expertise in the research area). (umn.edu)
  • Doing so offers the potential to save research costs, to bring the better technology to patients sooner, and to reduce the number of patients randomised into the trial. (whiterose.ac.uk)
  • CDMRP receives annual appropriations that are disease or condition-specific and for the FY22 budget has added Friedreich Ataxia to the list of topic areas eligible for $370M in funding within the Peer-Reviewed Medical Research Programs . (curefa.org)
  • We also include some records, such as this one, that illustrate progress in the evaluation of animal and other pre-clinical research. (jameslindlibrary.org)
  • In the coming months, CDC in collaboration with trial investigators and other partners, will be reviewing the data, both to develop interim clinical guidance, as well as to outline key additional research questions moving forward. (cdc.gov)
  • Clinical research is necessary to establish the safety and effective- ness of specifi c health and medical products and practices. (who.int)
  • Compliance with GCP provides public assurance that the rights, safety, and wel -being of research subjects are protected and respected, consistent with the principles enunciated in the Declaration of Helsinki and other internationally recognized ethical guidelines, and ensures the integrity of clinical research data. (who.int)
  • The conduct of clinical research is complex and this complexity is compounded by the need to involve a number of dif- ferent individuals with a variety of expertise, all of who must perform their tasks skil ful y and effi ciently. (who.int)
  • Trial registration: ClinicalTrials.gov NCT04251429 (retrospectively registered January 29, 2020), protocol version 1. (cdc.gov)
  • Effect of behavioral interventions on inappropriate antibiotic prescribing among primary care practices: a randomized clinical trial. (ahrq.gov)
  • A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. (nih.gov)
  • Proposals should prove the feasibility of integrating the proposed interventions in current pain management, palliative and/or end-of-life and/or survivorship care regimes and healthcare systems across Europe while taking into account the complex human aspects which are necessarily managed by such regimes and systems. (europa.eu)
  • Create informational documentation about the initiative and ensure that resources are available to UMN faculty to support multi-site trial development, including flexible technology solutions for healthcare sites and travel to greater Minnesota communities to support recruitment, participant visits, and relationship building. (umn.edu)
  • This topic is important to clinicians practising in publicly funded healthcare systems as they rely on evidence-based treatment strategies that have been shown to be effective in comparison to alternative interventions. (whiterose.ac.uk)
  • We also discuss the steps that might be taken by funders, clinicians, trial teams, the public and healthcare decision makers to successfully deploy these methods. (whiterose.ac.uk)
  • Therefore, the purpose of this paper is to propose a clinical guideline for designing an abutment/prosthesis based on implant position. (researchgate.net)
  • His clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and endovascular intervention. (duke.edu)
  • In this cluster randomized trial among 47 primary care practices, prompting clinicians to enter justifications for prescribing antibiotics in patients with antibiotic-inappropriate diagnoses or providing peer comparisons through emails decreased mean antibiotic prescribing rates compared to controls. (ahrq.gov)
  • Nortriptyline and interpersonal psychotherapy as maintenance therapies for recurrent major depression: a randomized controlled trial in patients older than 59 years. (athealth.com)
  • Articles include a wide range of topics affecting the care of patients from preventive care to acute care across the lifespan. (medscape.com)
  • His is involved in several clinical trials involving patients with cardiovascular disease and in cardiac imaging. (duke.edu)
  • 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)
  • Dimethyl fumarate (DMF) could delay - or even prevent - clinical symptoms in patients with radiologically isolated syndrome (RIS), the earliest detected pre-clinical phase of multiple sclerosis. (medscape.com)
  • Up to half patients with RIS experience a first clinical MS event within 10 years. (medscape.com)
  • Diagnostic criteria and whether to treat patients with RIS prophylactically has long been a topic of debate among neurologists and radiologists. (medscape.com)
  • This type of intervention has been used in brain injury patients and is more effective in people with right-sided brain injuries than left-sided brain injuries. (apdaparkinson.org)
  • While a variety of interventions are in use, these are often not adequately validated or adapted to the specific needs of patients affected with a specific chronic disease or with multimorbidities. (europa.eu)
  • only 2 patients required surgical intervention for local progression or symptoms. (medscape.com)
  • The treatment of metastatic RCC is problematic, so whenever possible, patients should be directed to approved and controlled clinical trials. (medscape.com)
  • A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). (clinicaltrials.gov)
  • 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)
  • Typically patients left in the trial were white men in their early thirties and not in full-time employment. (findings.org.uk)
  • In recent years, clinical trials have established targeted therapy as the first-line treatment in patients with metastatic disease. (medscape.com)
  • Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 in PAR-18-430 . (nih.gov)
  • 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)
  • Supports the rapid implementation of clinical trials of novel interventions. (curefa.org)
  • Effect of prescriber notifications of patient's fatal overdose on opioid prescribing at 4 to 12 months: a randomized clinical trial. (ahrq.gov)
  • CONCLUSIONS: Behavioral-psychosocial, SSP, OAT, FSI, and CM interventions are effective in reducing risk of HIV and sequelae of injection and other drug use, and they have a continuing role in addressing the opioid crisis and Ending the HIV Epidemic. (cdc.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)
  • Multiple interventions could boost recruitment, retention, and the structural efficiency of health care delivered by these professions. (rand.org)
  • This brief describes potential interventions to boost recruitment and retention in Virginia's health care workforce and increase its structural efficiency. (rand.org)
  • what health interventions are studied? (asthma.ca)
  • The unit of intervention is a work place health and safety committee, adapted here to a joint labor-management " Design Team" (DT). (cdc.gov)
  • SHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA) and/or cognitive training intervention (CT) in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment. (biomedcentral.com)
  • Marcel SALIVE , Health Scientist Administrator, Division of Geriatrics and Clinical Gerontology (DGCG) . (nih.gov)
  • 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)
  • The School of Public Health Division of Biostatistics is pleased to offer PUBH 3415/7415: Introduction to Clinical Trials. (umn.edu)
  • This National Institutes of Health (NIH)-funded study is the first rigorous clinical trial to suggest that a behavioral intervention, alone or in combination with a vaccine, can help protect older adults from VZV, which causes both chickenpox and shingles. (science20.com)
  • The health education intervention involved classes about a variety of health-related topics. (science20.com)
  • Measuring the quality of life of the elderly in health promotion intervention clinical trials. (cdc.gov)
  • The goal of the project is to set the groundwork for a larger clinical trial to test whether ADAPT+ can improve rural Latino families' health behaviors. (usf.edu)
  • This, combined with new insights into the pandemic's effect on mental health and promising findings regarding treatment options, resulted in anxiety becoming this week's top trending clinical topic. (medscape.com)
  • Value-adaptive designs are a set of emerging methods for efficient clinical trial design that aim to maximise expected population health for the money being spent. (whiterose.ac.uk)
  • The vast majority of records in the James Lind Library illustrate progress in the evaluation of clinical and public health interventions. (jameslindlibrary.org)
  • Gostin discusses interventions such as genetically engineered mosquitoes, long-lasting insecticidal bed nets, and vaccination, but cautions "optimism should be tempered…by the limits of traditional strategies, hurdles still to overcome for newer possibilities (from scientific challenges to special publics), and the weaknesses of the health systems. (cdc.gov)
  • The results allow elucidating the clinical of dysferlinopathies, providing relevant information to guide health professionals in the elaboration of evaluation and treatment protocols. (bvsalud.org)
  • In addition, two candidate vaccines - the cAd3-ZEBOV vaccine, developed by GlaxoSmithKline in collaboration with the United States National Institutes for Health, and the rVSV-ZEBOV vaccine, developed by NewLink Genetics (and later licenced to Merck Vaccines USA), in collaboration with Health Canada - were identified for further clinical studies. (who.int)
  • METHODS AND DESIGN: A total of 78 health facilities have been randomised (1:1:1) into one of two intervention arms or a standard-of-care arm. (lu.se)
  • This paper follows the published trial protocol and describes the protocol and analysis plan for the health economics work package of the ASCENT-Ethiopia trial. (lu.se)
  • What makes pragmatic trials different? (nih.gov)
  • Pragmatic trials also seem likely to allow greater participation of older adults. (nih.gov)
  • NIA is particularly interested in conducting additional pragmatic trials. (nih.gov)
  • The purpose of this study is to refine and test the acceptability and feasibility of a culturally competent, evidence-based, community-centered obesity lifestyle modification intervention, ADAPT+, using mindfulness strategies. (usf.edu)
  • March 05, 2018 Notice: Refinement and Testing of Interventions to Sustain ADHD Treatment Effects Across Settings and Developmental Transitions. (nih.gov)
  • Clinical trials help researchers know whether a new treatment works well and is safe. (medlineplus.gov)
  • If you join a trial, you may get treatment that can help you. (medlineplus.gov)
  • You can find clinical trials listed on the website of the National Cancer Institute (NCI) -- www.cancer.gov/about-cancer/treatment/clinical-trials . (medlineplus.gov)
  • Go to Renal Cell Carcinoma Treatment Protocols , Clear Cell Renal Cell Carcinoma , and Sarcomatoid and Rhabdoid Renal Cell Carcinoma for complete information on these topics. (medscape.com)
  • Update your breast cancer knowledge on topics like genomic testing, biosimilars, clinical trials, new treatment options, cardio-oncology and much more with the Breast Cancer: Staying Up to Date online course. (ons.org)
  • According to a trial of over 500 individuals , these improvements lasted at least 6 months after treatment was discontinued. (medscape.com)
  • 1 These trials assign trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. (who.int)
  • Clinical trials are currently exploring possible future directions in treatment. (medscape.com)
  • The ASCENT-Ethiopia study is a three-arm cluster randomised trial assessing two DATs with differentiated care for supporting tuberculosis treatment adherence in Ethiopia. (lu.se)
  • The proposed study will not negatively impact enrollment for active studies recruiting the same clinical and geographic population. (umn.edu)
  • The authors first provide a brief review of previous intervention studies by summarizing the findings and discussing implications. (humankinetics.com)
  • The clinical of muscle weakness is not correlated with functional findings. (bvsalud.org)
  • Subsequent to committee findings and discussions, WHO actively engaged with partners, industry and regulatory authorities to expedite clinical trials and regulatory approval pathways for the potential deployment of proven medical products in the affected countries. (who.int)
  • Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. (bmj.com)
  • higher scores favour experimental intervention. (bmj.com)
  • Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). (bmj.com)
  • Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. (bmj.com)
  • 1 In a study of trials of multiple myeloma the authors' conclusions-that is, the authors' reported interpretation of the overall trial results-were more positive towards the benefit of experimental interventions in those trials that were funded by the pharmaceutical industry compared with trials that were funded by non-profit organisations. (bmj.com)
  • On 11 November, the Organization convened a meeting of the newly created Scientific and Technical Advisory Group on Ebola Experimental Interventions (STAC-EE). (who.int)
  • This close relationship implies that we have a strong interest in biobanks of diseases of interest, use routine collected (clinical, pharmacy, claims) data and are involved in many clinical trials (preferably with a laboratory component). (erasmusmc.nl)
  • The book is separated into 2 sections: "Growing Threats" encompasses topics as diverse as mosquitoborne diseases, climate change, and biosafety and biosecurity. (cdc.gov)
  • Potential challenges include difficulty in pooling data across study sites if Design Teams select different intervention topics, and follow-up periods too short for change to be observed. (cdc.gov)
  • Concerns about the external validity of traditional randomized clinical trials (RCTs), together with the widespread availability of real-world data and advanced data analytic tools, have led to claims that common sense and clinical observation, rather than RCTs, should be the preferred method to generate evidence to support clinical decision-making. (duke.edu)
  • The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. (biomedcentral.com)
  • These committees are: a Trial Management Group (TMG) that oversees the day-to-day running of the trial, a Data Monitoring Committee (DMC) that reviews accumulating data and a Trial Steering Committee (TSC), with independent members, that provides oversight and supervision [ 2 ]. (biomedcentral.com)
  • Among 51 trials that had data reported both in ClinicalTrials.gov and publication, 60.8% were in phase 1. (irb.hr)
  • The STAC-EE reviewed clinical trial protocols and data for blood products and medicines. (who.int)
  • SHARP-P was a single-blinded pilot randomized controlled trial that involved the delivery of a cognitive training intervention and/or a physical training intervention in a 2 × 2 factorial design. (biomedcentral.com)
  • The purpose of this article is to provide an overview and explore opportunities to continue large-scale physical education curriculum intervention studies. (humankinetics.com)
  • Physical exercise interventions are known to alter the epigenome, but little is known about their association with exergames. (bvsalud.org)
  • Multi-level interventions are needed to address interacting exposures and their overlapping origins in work organization features. (cdc.gov)
  • 6. In accordance with the WHO and ICMJE recommendations, EMHJ requires registration of clinical trials in a public trials registry as a condition for considering papers for publication. (who.int)
  • The studies are broad, but do not contemplate aspects that allow a critical and wide analysis on the functionality and therapeutic intervention. (bvsalud.org)
  • This trial is being conducted across 170 medical centers in the United States, Canada, Israel, Spain, and Australia. (wikipedia.org)
  • Interdisciplinary Center for Evaluation and Intervention (ICEI) is part of a statewide network of Florida Diagnostic and Learning Resources (FDLRS) Multi-Disciplinary Centers (MDC). (usf.edu)
  • Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. (bmj.com)
  • BACKGROUND: Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort. (mcmaster.ca)
  • DISCUSSION: MYB will be the largest internet-based trial to attempt to prevent cognitive decline and potentially dementia. (mcmaster.ca)
  • He is now conducting clinical trials to test whether medications, exercise interventions, and surgical correction of the blockage can reverse these morbidities. (wikipedia.org)
  • Active surveillance may be an acceptable approach to delay or avoid further intervention in the patient at high surgical risk. (medscape.com)
  • The Food and Drug Administration granted marketing clearance Friday to Power Medical Interventions Inc. for its iDrive surgical devices. (blogspot.com)
  • Results of this initial trial suggest that future interventions to improve medical test conversations and reduce test overuse might focus on easing physician adoption barriers and leveraging patient-clinician relationships. (rand.org)
  • Results Of 626 published randomised clinical trials, 109 (17%) used a surrogate as a primary outcome. (bmj.com)
  • However, over the past 4 decades, results from well-done RCTs have repeatedly contradicted practices supported by common sense and clinical observation. (duke.edu)
  • and other interventions on the incidence for simplified, affordable technology of and mortality from gastric cancer. (who.int)
  • 3 These measures are all considered to be in the causal pathway for the clinical outcome. (bmj.com)
  • Of these trials, 62 (57%, 95% confidence interval 47% to 67%) clearly reported that the primary outcome was a surrogate. (bmj.com)
  • Conclusion Only about one third of authors of randomised clinical trials that used a surrogate as a primary outcome reported adequately on the surrogate. (bmj.com)
  • The main one arises when the intervention causes a "positive" response on the surrogate but has no effect, or a harmful effect, on the clinical outcome, or vice versa. (bmj.com)
  • Sometimes, however, the surrogate may not be causally or strongly related to the clinical outcome, but only a concomitant factor, and thus may not predict the effect on the clinical outcome. (bmj.com)
  • and if one or, even better, many randomised trials on similar drug classes have established that the intervention's effect on the surrogate captures the intervention's effect on the clinical outcome. (bmj.com)
  • We evaluated if authors of randomised clinical trials convey the fact that they have used a surrogate as a primary outcome and have discussed the surrogate's validity. (bmj.com)
  • My outcome in this study was how sleep can be improved based on receiving this intervention. (sc.edu)
  • Studies proposing to validate a diagnostic biomarker/biomarker signature must be able to differentiate the patient population(s) of interest against the gold standard outcome such as an established clinical outcome assessment battery, postmortem pathology, or against another/other established diagnostic tool(s). (nih.gov)
  • Studies proposing to validate a prognostic biomarker/biomarker signature should demonstrate the accuracy of the biomarker's ability to predict the likelihood of a clinical event or outcome(s) within a clinically useful defined time-period. (nih.gov)
  • Convalescent plasma entered trial phase in Guinea and Liberia in December. (who.int)
  • Forum (AVAREF), where regulators and ethicists agreed to conduct joint ethical and regulatory reviews to expedite approval of later phase vaccine clinical trials in African countries. (who.int)
  • On December 15-16, National ethics and regulatory authorities from Cameroon, Ghana, Mali, Nigeria and Senegal met at WHO to expedite approval through a joint review of GSK's phase 2 clinical trial application for the cAd3-ZEBOV vaccine. (who.int)
  • The approaches tested must be based on widely accepted interventions previously demonstrated to be efficacious in clinical trials. (nih.gov)
  • We conducted summary meta-analyses separately for reviews of randomized controlled trials (RCTs) and quasi-experiments. (cdc.gov)
  • Before definitive trials are mounted, it is important to conduct pilot studies that address important practical concerns. (biomedcentral.com)
  • Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. (biomedcentral.com)
  • CTUs are specialist units with a specific remit to work with the leading investigators to design, conduct, analyse and publish clinical trials and other studies [ 7 ]. (biomedcentral.com)
  • The final chapter, "Global Medical War Chest," focuses on regulatory considerations, market incentives, and clinical trial design for medical countermeasure development. (cdc.gov)
  • Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. (nih.gov)
  • Therefore a need exists to strengthen the evidence base for available effective interventions improving quality of life in the domains of palliative, end-of-life and survivorship care. (europa.eu)
  • If successful, MYB will provide a model for not just effective intervention among older adults, but an intervention that is scalable for broad use. (mcmaster.ca)
  • Inclusion criteria: English, Portuguese and Spanish, articles of clinical trial and review, with humans, from 2006 to 2016. (bvsalud.org)
  • The primary aim of this mixed-methods study is to determine if there are clinically relevant differences among those with pre-diabetes and excess weight who regress to normoglycaemia, those who have persistent pre-diabetes and those who progress to T2DM following participation in a 6-month primary care nurse-delivered pre-diabetes dietary intervention. (nih.gov)
  • For a full listing of possible study topics, see the grant announcement listing in the NIH Guide ( http://grants1.nih.gov/grants/guide/index.html ). (nih.gov)
  • in the "lagged intervention" site, coaching begins about half-way through the study. (cdc.gov)
  • Discussion: This study aims for a quantitative evaluation of the HWPP over a time period long enough to accomplish multiple intervention cycles in each facility. (cdc.gov)
  • Clinical trials are also monitored during the entire study. (medlineplus.gov)
  • Before you join a clinical trial, you will learn about the safety guidelines, what is expected of you, and how long the study will last. (medlineplus.gov)
  • Each clinical study has guidelines about who can join. (medlineplus.gov)
  • Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials' TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. (biomedcentral.com)
  • I have led a number of large international clinical studies in heart attacks, unstable angina, heart failure, and atrial fibrillation. (duke.edu)
  • NIA recently joined with other NIH Institutes to fund studies using a pragmatic clinical trial approach. (nih.gov)
  • How would it differ from a registry of clinical trials? (cmaj.ca)
  • We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. (nih.gov)
  • To assess the association between competing interests and authors' conclusions in randomised clinical trials. (bmj.com)
  • We analysed the association between financial and other competing interests and authors' conclusions in randomised clinical trials published in the BMJ . (bmj.com)
  • We used the Template for Intervention Description and Replication items to assess the quality of intervention description in both ClinicalTrials.gov Descriptive Information section and matching publications. (irb.hr)
  • The center provides comprehensive evaluations, consultations, and interventions at no cost for children and youth aged 3-21 who have medical, educational, emotional, or behavioral problems. (usf.edu)
  • Use the MeSH headings Clinical Trials, Veterinary as Topic and Randomization for the general design, methodology, economics, etc. of randomized veterinary clinical trials. (bvsalud.org)
  • We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. (nih.gov)
  • Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial. (biomedcentral.com)