دانلود و نمایش مقالات مرتبط با clinical trial::صفحه 1
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نتیجه جستجو - clinical trial

تعداد مقالات یافته شده: 49
ردیف عنوان نوع
1 Effects of a symptom management intervention based on group sessions combined with a mobile health application for persons living with HIV in China: A randomized controlled trial
اثرات مداخله مدیریت علائم بر اساس جلسات گروهی همراه با یک برنامه بهداشتی همراه برای افراد مبتلا به HIV در چین: یک آزمایش تصادفی کنترل شده-2021
Objective: This study aims to evaluate the effects of a symptom management intervention (SMI) based on symptom management group sessions combined with a mobile health (mHealth) application (app) on the knowledge of symptom management, the certainty of symptom self-management, symptom severity, symptom distress, medication adherence, social support, and quality of life among persons living with HIV (PLWH) in China.
Methods: A parallel randomized controlled trial with 61 PLWH was conducted in Shanghai, China. The participants in the control group (n ¼ 30) downloaded the Symptom Management (SM) app according to their needs and preferences, and received routine follow-ups. The participants in the intervention group (n ¼ 31) were guided to download and use the SM app, and received four tailored weekly group sessions at routine follow-ups. Each group session lasted for approximately 2 h and targeted one of the major modules of the SM app. All the outcomes were assessed at baseline and post-intervention. The study was registered with the Chinese Clinical Trial Registry (ChiCTR1900024821).
Results: The symptom management knowledge and certainty of symptom self-management were significantly improved after the intervention (all P < 0.01). Compared with the control group, the scores of symptoms reasons knowledge score improved 11.47 points (95% CI: 3.41, 19.53) and scores of symptoms self-management knowledge score improved 12.80 points (95% CI: 4.55, 21.05) in the intervention group after controlling for covariates. However, other outcomes did not show statistically significant differences between the intervention group and the control group (P > 0.05).
Conclusion: The SMI could improve PLWH’s symptom management knowledge and certainty of symptom self-management. Multi-center studies with larger sample sizes and longer follow-ups are needed to further understand the effects of SM app on ameliorating symptom severity and symptom distress. More innovative strategies are also needed to promote and maintain the sustainability of the SM app.
keywords: چین | عفونت های HIV | برنامه های موبایل | پیروی از دارو | کیفیت زندگی | خود مدیریت | حمایت اجتماعی | China | HIV Infections | Mobile applications | Medication adherence | Quality of life | Self-management | Social support
مقاله انگلیسی
2 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
3 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
4 Adaptive finite element eye model for the compensation of biometric influences on acoustic tonometry
مدل چشم اجزای محدود تطبیقی برای جبران تأثیرات بیومتریک بر تونومتری آکوستیک-2021
Background and objective: Glaucoma is currently a major cause for irreversible blindness worldwide. A risk factor and the only therapeutic control parameter is the intraocular pressure (IOP). The IOP is determined with tonometers, whose measurements are inevitably influenced by the geometry of the eye. Even though the corneal mechanics have been investigated to improve accuracy of Goldmann and air pulse tonometry, influences of geometric properties of the eye on an acoustic self-tonometer approach are still unresolved.
Methods: In order to understand and compensate for measurement deviations resulting from the geometric uniqueness of eyes, a finite element eye model is designed that considers all relevant eye components and is adjustable to all physiological shapes of the human eye.
Results: The general IOP-dependent behavior of the eye model is validated by laboratory measurements on porcine eyes. The difference between simulation and measurement is below 8 μm for IOP levels from 5 to 40 mmHg. The adaptive eye model is then used to quantify systematic uncertainty contributions of a variation of eye length and central corneal thickness based on input statistics of a clinical trial series. The adaptive eye model provides the required relation between biometric eye parameters and the corneal deflection amplitude, which here is the measured quantity to trace back to the IOP. Implementing the relations provided by the eye model in a Gaussian uncertainty propagation calculation now allows the quantification of the uncertainty contributions of the biometric parameters on the overall measurement uncertainty of the acoustic self-tonometer. As a result, a systematic uncertainty contribution resulting from deviations in eye length dominate stochastic deviations of the sensor equipment by a factor of 3.5.
Conclusion: As perspective, the proposed adaptive eye model provides the basis to compensate for systematic deviations of (but not only) the acoustic self-tonometer.
Keywords: Corneal vibration | Transient simulation | FEM | Eye model | Intraocular pressure | Glaucoma
مقاله انگلیسی
5 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
6 Can paracetamol lower stress and anxiety by blunting emotions during and after computer guided dental implant surgeries? Findings from a randomized crossover clinical trial
آیا پاراستامول می تواند استرس و اضطراب را با کاستن احساسات در حین و بعد از جراحی های ایمپلنت دندان با رایانه کاهش دهد؟ یافته های یک کارآزمایی بالینی متقاطع تصادفی-2021
Background/purpose: Dental implants insertion can be a major factor in stress and anxiety. The aim was to evaluate the paracetamol ability to lower stress and anxiety when compared with ibuprofen during and after computer guided implant surgery utilizing CAD/ CAM surgical template and a computer vision system for assessment.
Materials and methods: Thirty patients were enrolled in a crossover study design having bilateral missing lower molars. Patients were randomized into 2 equal groups with the first assigned for dental implant insertion in the lower molar area on one side with the administration of paracetamol (with 7-day follow-up) followed by 2-week washout period, then another implant was inserted on the contra-lateral side with ibuprofen. The second group received the same drugs but in reversed order. Salivary cortisol level was used to measure anxiety and a computer vision system was used to measure swelling. Visual-Analogue-Scale pain score from 0-to-100 was also utilized.
Results: Only 29 patients completed the study. Stress and anxiety was found to be significantly lower in paracetamol group (4.1  1.08 ng/mL and 6.2  0.94 ng/mL for paracetamol/ ibuprofen respectively). Pain score was 13.1  1.1 and 12.9  2.3 in paracetamol/ibuprofen groups respectively with no significant differences. Swelling showed significant difference favoring the paracetamol group (0.91  0.41 and 0.61  0.31 for paracetamol/ibuprofen respectively).
Conclusion: Paracetamol is effective in reducing stress by minimizing anxiety and blunting emotions of “fear-from-pain” so that pain is no longer perceived as much. However, paracetamol lacks the ability to control swelling at implant site. Computer guided flapless-implant surgery with immediate loading can be recommended for fearful patients.
KEYWORDS: ne-piece implant | Computer vision | system | Acetaminophen | Ibuprofen | Pain | Salivary cortisol
مقاله انگلیسی
7 Host transcriptomic signature as alternative test-of-cure in visceral leishmaniasis patients co-infected with HIV
امضای transcriptomic میزبان به عنوان گزینه درمانی جایگزین در بیماران لیشمانیوز احشایی آلوده به HIV-2020
Visceral leishmaniasis (VL) treatment in HIV patients very often fails and is followed by high relapse and case-fatality rates. Hence, treatment efficacy assessment is imperative but based on invasive organ aspiration for parasite detection. In the search of a less-invasive alternative and because the host immune response is pivotal for treatment outcome in immunocompromised VL patients, we studied changes in the whole blood transcriptional profile of VL-HIV patients during treatment. Methods: Embedded in a clinical trial in Northwest Ethiopia, RNA-Seq was performed on whole blood samples of 28 VL-HIV patients before and after completion of a 29-day treatment regimen of AmBisome or AmBisome/ miltefosine. Pathway analyses were combined with a machine learning approach to establish a clinically-useful 4-gene set. Findings: Distinct signatures of differentially expressed genes between D0 and D29 were identified for patients who failed treatment and were successfully treated. Pathway analyses in the latter highlighted a downregulation of genes associated with host cellular activity and immunity, and upregulation of antimicrobial peptide activity in phagolysosomes. No signs of disease remission nor pathway enrichment were observed in treatment failure patients. Next, we identified a 4-gene pre-post signature (PRSS33, IL10, SLFN14, HRH4) that could accurately discriminate treatment outcome at end of treatment (D29), displaying an average area-under-the-ROC-curve of 0.95 (CI: 0.751.00). Interpretation: A simple blood-based signature thus holds significant promise to facilitate treatment efficacy monitoring and provide an alternative test-of-cure to guide patient management in VL-HIV patients. Funding: Project funding was provided by the AfricoLeish project, supported by the European Union Seventh Framework Programme (EU FP7).
Keywords: Visceral leishmaniasis | HIV | RNA signature | Treatment efficacy | Blood signature
مقاله انگلیسی
8 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
9 Lessons Learned About Autonomous AI: Finding a Safe, Efficacious, and Ethical Path Through the Development Process
درسهایی که درباره هوش مصنوعی مستقل آموخته اند: یافتن راهی ایمن ، کارآمد و اخلاقی از طریق فرایند توسعه-2020
Artificial intelligence (AI) describes systems capable of making decisions of high cognitive complexity; autonomous AI systems in healthcare are AI systems that make clinical decisions without human oversight. Such rigorously validated medical diagnostic AI systems hold great promise for improving access to care, increasing accuracy, and lowering cost, while enabling specialist physicians to provide the greatest value by managing and treating patients whose outcomes can be improved. Ensuring that autonomous AI provides these benefits requires evaluation of the autonomous AI’s effect on patient outcome, design, validation, data usage, and accountability, from a bioethics and accountability perspective. We performed a literature review of bioethical principles for AI, and derived evaluation rules for autonomous AI, grounded in bioethical principles. The rules include patient outcome, validation, reference standard, design, data usage, and accountability for medical liability. Application of the rules explains successful US Food and Drug Administration (FDA) de novo authorization of an example, the first autonomous point-of-care diabetic retinopathy examination de novo authorized by the FDA, after a preregistered clinical trial. Physicians need to become competent in understanding the potential risks and benefits of autonomous AI, and understand its design, safety, efficacy and equity, validation, and liability, as well as how its data were obtained. The autonomous AI evaluation rules introduced here can help physicians understand limitations and risks as well as the potential benefits of autonomous AI for their patients. (Am J Ophthalmol 2020;214:134–142.
مقاله انگلیسی
10 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
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