دانلود و نمایش مقالات مرتبط با Clinical trials::صفحه 1
دانلود بهترین مقالات isi همراه با ترجمه فارسی 2
نتیجه جستجو - Clinical trials

تعداد مقالات یافته شده: 34
ردیف عنوان نوع
1 Time management: Improving the timing of post-prostatectomy radiotherapy, clinical trials, and knowledge translation
مدیریت زمان: بهبود زمان رادیوتراپی پس از پروستاتکتومی، آزمایشات بالینی و ترجمه دانش-2021
Background: Management of prostate cancer after surgery is controversial. Past studies on adjuvant radiotherapy (aRT) for higher-risk features have had conflicting results. Through the collaborative conversations of the global radiation oncology Twitter-based journal club (#RadOnc #JC), we explored this complex topic to share recent advances, better understand what the global radiation oncology community felt was important and inspire next steps. Methods: We selected the recent publication of a landmark international randomized controlled trial (RCT) comparing immediate and salvage radiotherapy for prostate cancer, RADICALS-RT, for discussion over the weekend of January 16 to 17, 2021. Coordination included open access to the article and an asynchronous portion to decrease barriers to participation, cooperation of study authors (CP, MS) who participated to share deeper insights including a live hour, and curation of related resources and tweet content through a blog post and Wakelet journal club summary. Discussion of Results: Our conversations created 2,370,104 impressions over 599 tweets with 51 participants spanning 11 countries and 5 continents. A quarter of the participants were from the US (13/51) followed by 10% from the UK (5/51). Clinical or Radiation Oncologists comprised 59% of active participants (16/27) with 62% (18/29) reporting giving aRT within the last 5 years. Discussion was interdisciplinary with three urologists (11%), three trainees (11%), and two physiotherapists (7%). Four months after the journal club its article Altmetric score had increased by 7% (214 to 229). Thematic analysis of tweet content suggested participants wanted clarification on definitions of adjuvant (aRT) and salvage radiotherapy (sRT) including indications, timing, and decision-making tools including guidelines; more interdisciplinary and cross-sectoral collaboration including with patients for study design including survivorship and meaningful outcomes; more effective knowledge translation including faster clinical trials; and more data including mature results of current trials, particular high-risk features (Gleason Group 4+, pT4b+, and margin-positive disease), implications of newer technologies such as PSMA-PET and genomic classifiers, and better explanations for practice pattern variations including underutilization of radiotherapy. This was further explored in the context of relevant literature. Conclusion: Together, this global collaborative review on the postoperative management of prostate cancer suggested a stronger signal for the uptake of early salvage radiation treatment with careful PSA monitoring, more sensitive PSA triggers, and expected access to radiotherapy. Questions still remain on potential exceptions and barriers to use. These require better decision-making tools for all practice settings, consideration of newer technologies, more pragmatic trials, and better use of social media for knowledge translation.
Keywords: Prostate radiotherapy | Adjuvant radiation | Salvage radiation | Journal club
مقاله انگلیسی
2 A Study on the Optimal Inventory Allocation for Clinical Trial Supply Chains
یک مطالعه در مورد اختصاص مطلوب موجودی برای زنجیره های تأمین کارآزمایی بالینی-2021
With increasing competition in the pharmaceutical industry, pharmaceutical companies pay more attention to improving the efficiency of clinical trial supply chains to reduce the drug supplying cost, which takes up a considerable part of the total research and development expense. To improve the efficiency of clinical trial supply chains, this study investigates the inventory levels of clinical drugs in each period at a distribution center and clinics considering the reverse replenishment, transshipment, and generalized stockout cost. The inventory allocation problem in clinical trial supply chains is formulated as a rolling horizon-based two-stage stochastic mixed-integer model where the minimal operational cost constitutes the underage cost at the production planning level of clinical trial supply chains. An algorithm extending Benders decomposition is proposed as the solution approach. We also derive several structural results and develop the reformulation method and row generation strategy to improve the efficiency of the optimization process. The effectiveness of our approach is demonstrated in the numerical experiment.
Keywords: Supply chain management | Clinical trials | Inventory allocation | Stochastic programming
مقاله انگلیسی
3 Knowledge gaps and perceptions of future research directions on management of diabetes during Ramadan fasting: An online survey of physicians
شکاف های دانش و درک دستورالعمل های تحقیقاتی آینده در مدیریت دیابت در طول روزهداری ماه رمضان: مرور آنلاین پزشکان-2021
Objectives: Current knowledge and research on diabetes and Ramadan form the basis for evidence-based clinical practice. In this context, we aimed to explore physicians’ perceptions of current knowledge gaps about research fasting (RF), barriers to, and foreseeable directions for advancement of the field.
Methods: We conducted an online survey of a convenience sample of 260 physicians from 27 countries. The survey questionnaire addressed three main domains: perceived current knowledge gaps and unmet needs in research about RF and diabetes, barriers to the conduct of research, and future directions for furthering the evidence in this field.
Results: Majority of respondents (65.7%) were senior physicians in adult endocrinology/diabetes (45.9%) working at tertiary centers (65.2%). The majority (67.3%) reported seeing an average of 20+ patients with diabetes weekly and felt ‘‘very or fairly confident” in managing diabetes during RF (67.7%). The knowledge gaps identified were the management of highrisk patients with diabetes (54.1%), such as renal impairment (59.8%), and pregnancy (61.5%). The main barriers to research were lack of adequate funding to academic centers (75.7%) and lack of interest of institutions in the subject (64.6%). Future efforts should be directed at the conduct of large epidemiological studies (49.5%) or double-blinded, placebo-controlled clinical trials (48.6%) to address the former gaps. Research findings should be widely disseminated via hands-on workshops (recommended by 70.3% of respondents) or international conferences (61.2%).
Conclusions: There is a wide agreement regarding the knowledge gaps in the management of diabetes during RF. Future efforts should focus on addressing these critical deficiencies.
keywords: روزه رمضان | ادبیات | دیابت | هیپوگلیسمی | همهگیرشناسی | کتواسیدوز دیابتی | دیدگاه های بیماران | متخصصان مراقبت های بهداشتی | ادراک | بیماران پر خطر | کودکان و نوجوانان | Ramadan fasting | Literature | Diabetes | Hypoglycaemia | Epidemiology | Diabetic ketoacidosis | Patients’ perspectives | Health Care Professionals | perceptions | High-risk patients | Children and adolescents
مقاله انگلیسی
4 Pharmaceutical R & D pipeline management under trial duration uncertainty
مدیریت خط لوله تحقیق و توسعه دارویی تحت عدم قطعیت آزمایش-2020
We consider a pharmaceutical Research & Development (R & D) pipeline management problem under two significant uncertainties: the outcomes of clinical trials and their durations. We present an Approximate Dynamic Programming (ADP) approach to solve the problem efficiently. Given an initial list of potential drug candidates, ADP derives a policy that suggests the trials to be performed at each decision point and state. For the classical R&D pipeline planning problem with deterministic trial durations, we compare our ADP approach with other methods from the literature, and find that it can find better solutions more quickly in particular for larger problem instances. For the case with stochastic trial durations, we compare the ADP algorithm with a myopic approach and show that the expected net profit obtained by the derived ADP policy is higher (almost 20% for a 10-drug portfolio).
Keywords: Dynamic programming | Pharmaceutical R&D pipeline management | Heuristics | Approximate dynamic programming | Project scheduling
مقاله انگلیسی
5 What electrophysiology tells us about Alzheimer’s disease: a window into the synchronization and connectivity of brain neurons
آنچه الکتروفیزیولوژی در مورد بیماری آلزایمر به ما می گوید: پنجره ای برای هماهنگ سازی و اتصال نورون های مغز-2020
Electrophysiology provides a real-time readout of neural functions and network capability in different brain states, on temporal (fractions of milliseconds) and spatial (micro, meso, and macro) scales unmet by other methodologies. However, current international guidelines do not endorse the use of electroencephalographic (EEG)/magnetoencephalographic (MEG) biomarkers in clinical trials performed in patients with Alzheimer’s disease (AD), despite a surge in recent validated evidence. This position paper of the ISTAART Electrophysiology Professional Interest Area endorses consolidated and translational electrophysiological techniques applied to both experimental animal models of AD and patients, to probe the effects of AD neuropathology (i.e., brain amyloidosis, tauopathy, and neurodegeneration) on neurophysiological mechanisms underpinning neural excitation/inhibition and neurotransmission as well as brain network dynamics, synchronization, and functional connectivity, reflecting thalamocortical and corticocortical residual capacity. Converging evidence shows relationships between abnormalities in EEG/MEG markers and cognitive deficits in groups of AD patients at different disease stages. The supporting evidence for the application of electrophysiology in AD clinical research as well as drug discovery pathways warrants an international initiative to include the use of EEG/MEG biomarkers in the main multicentric projects planned in AD patients, to produce conclusive findings challenging the present regulatory requirements and guidelines for AD studies.
Keywords: The Alzheimer’s Association International | Society to Advance Alzheimer’s Research | and Treatment (ISTAART) | Alzheimer’s disease (AD) | Electroencephalography and | magnetoencephalography (EEG and MEG) | Resting-state condition | Event-related potentials and magnetic fields | Preclinical and clinical research
مقاله انگلیسی
6 Increasing collaboration on substance use disorder research with primary care practices through the National Drug Abuse Treatment Clinical Trials Network
افزایش همکاری در زمینه تحقیق اختلال در مصرف مواد با اقدامات مراقبت های اولیه از طریق شبکه ملی آزمایش های بالینی درمان سوء مصرف مواد-2020
Background: The National Drug Abuse Treatment Clinical Trials Network (CTN) called for its national nodes to promote the translation of evidence-based interventions from substance use disorder (SUD) research into clinical practices. This collaborative demonstration project engaged CTN-affiliated practice-based research networks (PBRNs) in research that describes aspects of opioid prescribing in primary care. Methods: Six PBRNs queried electronic health records from a convenience sample of 134 practices (84 participants) to identify the percent of adult patients with an office visit who were prescribed an opioid medication from October 1, 2015, to September 30, 2016, and, of those, the percent also prescribed a sedative in that year. Seven PBRNs sent an e-mail survey to a convenience sample of 108 practices (58 participants) about their opioid management policies and procedures during the project year. Results: Of 561,017 adult patients with a visit to one of the 84 clinics in the project year, 22.9% (PBRN range 3.1%–25.4%) were prescribed opioid medications, and 52.1% (PBRN range 8.5%–60.6%) of those were prescribed a sedative in the same year. Of the 58 practices returning a survey (45.3% response rate), 98.1% had formal written treatment agreements for chronic opioid therapy, 68.5% had written opioid prescribing policies, and 43.4% provided reports to providers with feedback on opioid management. Only 24.1% were providing buprenorphine for OUD. Conclusion: CTN-affiliated PBRNs demonstrated their ability to collaborate on a project related to opioid management; results highlight the important role for PBRNs in OUD treatment, research, and the need for interventions and additional policies addressing opioid prescribing in primary care practice.
Keywords: Prescribing patterns | Opioids | Primary care | Electronic health records | Practice-based research
مقاله انگلیسی
7 The release of exosomes in the medial prefrontal cortex and nucleus accumbens brain regions of chronic constriction injury (CCI) model mice could elevate the pain sensation
انتشار اگزوزومها در قشر جلوی مغز داخلی و هسته مجذور مناطق مغزی از آسیب مدل انقباضی مزمن (CCI) موش مدل می تواند احساس درد را بالا ببرد-2020
Background: Brain function relies on the capacity of neurons to locally modulate each other at the level of synapses. Therefore, the exosomal pathway may constitute a well-designed mechanism for local and systemic interneuronal transfer of information within functional brain networks. Exosomes bind to and are endocytosed by neurons of different brain regions to play a definite role. The medial prefrontal cortex (mPFC) and nucleus accumbens (NAc) brain regions are known to involve in pain modulation. Our study observes the roles of exosomal activity in these two dominant regions of the pain-related pathway, and there influence on the analgesic effects in CCI mice. Methods: We induced pain exosomes in the mPFC and NAc in the mice of chronic constriction injury of the sciatic nerve model to produce neuropathic pain, and assessed changes that might affect analgesic behaviors. These changes were measured through a combination of behavioral, surgical, and other cellular testings. Results: Our study found that pain expression was elevated in mice given exogenous exosomes isolated from CCI mice, especially at the 2 h and 4 h time interval, in mice given exosomes at the mPFC and NAc, respectively. We also found that inhibiting formation of pain exosomes through GW4869 within the mPFC and NAc can elevate the pain threshold. Conclusion: Results from our study supported the idea that the release of mPFC and NAc exosomes of CCI model has elevated the pain sensations in the subjected mice. This study will further help in designing new clinical trials, and will revolutionize the drug-induced anesthetic responses.
مقاله انگلیسی
8 ابزارهای تحلیلی در ارزیابی درمان دارویی بیماری های عصبی - یک مطالعه موردی
سال انتشار: 2020 - تعداد صفحات فایل pdf انگلیسی: 8 - تعداد صفحات فایل doc فارسی: 16
در این مقاله، اجرای روش تحلیلی و نتیجه رویکرد جدید برای نظارت بر آزمایشات بالینی و ارزیابی داروهای درمان بیماری های عصبی به طور دقیق شرح داده شده است. ابزار طراحی شده و روش اجرای آن از الگوریتم های مبتنی بر برنامه های تلفن همراه و شبکه های عصبی برای کمک و نظارت بر گزارش علائم در زمان استفاده می کند. طبق شواهد این تحقیق،گزارش دقیق وضعیت سلامت به همراه جمع آوری داده های سنسور می تواند آزمایشات بالینی را عینیت بخشد ، بنابراین به افزایش دقت فرایند کمک خواهد کرد. الگوریتم های طراحی شده برای آنالیز داده های سنسور wearable به منظور ارزیابی شدت لرزش یا دیسکینزی (از بین رفتن توان حرکت) و علاوه بر این، ارتباط داده های نظرسنجی بیمار با داده های سنسور به کار رفته است. بر اساس مشاهدات آزمایش های بالینی ، مجموعه ای از ملزومات در تأیید علائم بیماری های عصبی ، با تمرکز بر تعداد معدودی از افراد منتخب و با استفاده از سنسورهای زیست پزشکی wearable ثبت وفرموله شده اند. ابزار ساخته شده با استفاده از روشهای مرسوم نظرسنجی به همراه سنسور زیست پزشکی برای تشخیص علائم عصبی و ارزیابی شدت به کار می رود. سیستم تلفن همراه توسعه یافته با کمک آزمایشات بالینی و با استفاده از ارزیابی حالت مبتنی بر سنسور کار میکند. چنین رویکرد کمی، مکمل ارزیابی ذهنی بیمار از وضعیت سلامتی است. این مقاله پیرامون بحث درمورد جوانب مثبت و منفی چنین فرآیندی و تکمیل آن با فناوری است. روش موجود به ارزیابی وضعیت سلامت بیمار براساس پرسشنامه های تکرار شونده پاسخ می دهد ، که از نظر ما کاملا قابل کنترل نیست ، اما قابل اعتماد است. استفاده از تکنیک های اکتی گرافی (روش غیر تهاجمی ثبت دوره های فعالیت و استراحت انسان) و الکترومیوگرافی (توانایی عضله برای پاسخ، در زمان تحریک عصب) به معنای کارآیی برخی حرکات ، اما بیشتر از شناسایی لرزش PD و ارزیابی شدت ، در شناسایی و ارزیابی حالت دیسکینز یا N / FF کاربرد دارد. مجموعه ای از تکنیک های اضافی به منظور شناسایی حالات خاص بیماران برای PD (لرزش ، برادیکینزیا ، سختی ، کندی ذهنی و غیره) طراحی و اجرا شد. این مقاله شامل خلاصه ای از فرضیات تحقیق و نتایج اعتبارسنجی به دست آمده در طی مرحله مفهومی و آزمایشی سیستم دستیار آزمایش های بالینی IQPharma است. یافته های اصلی تحقیق ارائه شده، سه جنبه ارزیابی درمان دارویی از جمله: 1. ارزیابی وضعیت سلامت ذهنی بیمار - بر اساس پاسخ های نظرسنجی بیمار ، 2. تشخیص لرزش و ارزیابی شدت - براساس آنالیز داده های سنسور اینرسی و زیست پزشکی - ویژگی های جمع شده از اکتی گرافی و الکترومیوگرافی 3. ارزیابی رفلکس و درک ذهنی - بر اساس ارزیابی تمرین صفحه لمسی و دقت و ارزیابی تکمیلی بیمار را فراهم می کند.
کلمات کلیدی: ارزیابی آزمایشات بالینی | سنسورهای زیست پزشکی | همجوشی داده ها | سیستم موبایل | مهندسی پزشکی | بیماری پارکینسون | ارزیابی لرزش | سیستم حسگر | ابزار تحلیلی موبایل | تشخیص داخلی | اقدامات کمی
مقاله ترجمه شده
9 What Can We Learn About Drug Safety and Other Effects in the Era of Electronic Health Records and Big Data That We Would Not Be Able to Learn From Classic Epidemiology?
چه چیزی می توانیم درباره ایمنی دارو و سایر تأثیرات در عصر سوابق الکترونیکی سلامت و داده های بزرگی که نمی توانیم از اپیدمیولوژی کلاسیک یاد بگیریم؟-2020
As more and more health systems have converted to the use of electronic health records, the amount of searchable and analyzable data is exploding. This includes not just provider or laboratory created data but also data collected by instruments, personal devices, and patients themselves, among others. This has led to more attention being paid to the analysis of these data to answer previously unaddressed questions. This is especially important given the number of therapies previously found to be beneficial in clinical trials that are currently being re-scrutinized. Because there are orders of magnitude more information contained in these data sets, a fundamentally different approach needs to be taken to their processing and analysis and the generation of knowledge. Health care and medicine are drivers of this phenomenon and will ultimately be the main beneficiaries. Concurrently, many different types of questions can now be asked using these data sets. Research groups have become increasingly active in mining large data sets, including nationwide health care databases, to learn about associations of medication use and various unrelated diseases such as cancer. Given the recent increase in research activity in this area, its promise to radically change clinical research, and the relative lack of widespread knowledge about its potential and advances, we surveyed the available literature to understand the strengths and limitations of these new tools. We also outline new databases and techniques that are available to researchers worldwide, with special focus on work pertaining to the broad and rapid monitoring of drug safety and secondary effects.
Keywords: Electronic health record | Big data | Drug safety | Health care database | Cancer risk
مقاله انگلیسی
10 Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension
گزارش رهنمودهای گزارش های کارآزمایی بالینی برای مداخلات مربوط به هوش مصنوعی: پسوند CONSORT-AI-2020
The CONSORT 2010 statement provides minimum guidelines for reporting randomised trials. Its widespread use has been instrumental in ensuring transparency in the evaluation of new interventions. More recently, there has been a growing recognition that interventions involving artificial intelligence (AI) need to undergo rigorous, prospective evaluation to demonstrate impact on health outcomes. The CONSORT-AI (Consolidated Standards of Reporting Trials-Artificial Intelligence) extension is a new reporting guideline for clinical trials evaluating interventions with an AI component. It was developed in parallel with its companion statement for clinical trial protocols: SPIRIT-AI (Standard Protocol Items: Recommendations for Interventional Trials-Artificial Intelligence). Both guidelines were developed through a staged consensus process involving literature review and expert consultation to generate 29 candidate items, which were assessed by an international multi-stakeholder group in a two-stage Delphi survey (103 stakeholders), agreed upon in a two-day consensus meeting (31 stakeholders), and refined through a checklist pilot (34 participants). The CONSORT-AI extension includes 14 new items that were considered sufficiently important for AI interventions that they should be routinely reported in addition to the core CONSORT 2010 items. CONSORT-AI recommends that investigators provide clear descriptions of the AI intervention, including instructions and skills required for use, the setting in which the AI intervention is integrated, the handling of inputs and outputs of the AI intervention, the human–AI interaction and provision of an analysis of error cases. CONSORT-AI will help promote transparency and completeness in reporting clinical trials for AI interventions. It will assist editors and peer reviewers, as well as the general readership, to understand, interpret, and critically appraise the quality of clinical trial design and risk of bias in the reported outcomes.
مقاله انگلیسی
rss مقالات ترجمه شده rss مقالات انگلیسی rss کتاب های انگلیسی rss مقالات آموزشی
logo-samandehi