title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Declarations | PMC9969622 | |||
Ethics approval and consent to participate {24} | The trial is currently ongoing. The protocol was approved by the ethical committee board (CCER 2019–02469) in April 2020 and by ClinicalTrials.gov (Identifier: NCT04479397) in July 2020. All patients agree to participate, and a written consent will be obtained from all participants. | PMC9969622 | ||
Availability of data and materials {29} | All data will be available on request at the following email address: alexandre.laedermann@gmail.com. | PMC9969622 | ||
Consent for publication {32} | Informed consent from was approved by the ethical committee board (CCER 2019–02469) in April 2020. No identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. Informed consent materials are available from the corresponding author o... | PMC9969622 | ||
Competing interests {28} | FOUNDER | AL is a paid consultant for Stryker, Medacta, and Arthrex. He receives royalties from Stryker. He is the founder of FORE, BeeMed, and Med4Cast. He owns stock options of Medacta, BeeMed, and FollowHealth. The other authors declare that they have no competing interests. | PMC9969622 | |
References | PMC9969622 | |||
Subject terms | Treatment failure occurs in about 25% of patients with methicillin-susceptible New treatments are essential for methicillin-susceptible | PMC10579052 | ||
Results | MSSA bacteremia | MAY | Between 31 May 2019 and 24 February 2022, we assessed 925 patients with MSSA bacteremia for eligibility. After excluding 710 patients who were considered ineligible, we enrolled 215 patients, who were randomly assigned to receive cloxacillin plus fosfomycin ( | PMC10579052 |
Trial profile. | MSSA | CONSORT diagram indicating participant numbers and disposition throughout the course of the trail. *51 patients had more than one exclusion criterion.The primary endpoint was treatment success at day 7 after randomization, a composite endpoint comprising the following criteria: patient alive, stable or with improved qu... | PMC10579052 | |
Primary and secondary endpoints | SECONDARY | The results for primary and secondary endpoints in the intention-to-treat population are shown in Fig. | PMC10579052 | |
Discussion | comorbidity, endocarditis, bacteremia, infection, MSSA bacteremia, bloodstream infections | BLOODSTREAM INFECTION, RECURRENCE, ENDOCARDITIS, ADVERSE EVENTS, DISEASE, RECRUITMENT, INFECTION, SECONDARY | This open-label, phase III–IV superiority randomized clinical trial conducted in 19 Spanish hospitals aimed to evaluate whether the combination of cloxacillin and fosfomycin achieved better treatment success than cloxacillin alone in patients with MSSA bacteremia. The primary endpoint was chosen based on the recommenda... | PMC10579052 |
Methods | PMC10579052 | |||
Study design and setting | MSSA bacteremia | MAY | We performed an open-label, phase III–IV superiority randomized clinical trial of patients with MSSA bacteremia at 19 Spanish university hospitals (the SAFO trial). Participants were recruited from May 2019 to February 2022. Before inclusion in the trial, all patients or legal representatives provided written informed ... | PMC10579052 |
Participants | death, allergy, MSSA, liver cirrhosis, non-type, active infection | CHRONIC HEART FAILURE, HYPERSENSITIVITY REACTION, PROSTHETIC VALVE ENDOCARDITIS, ALLERGY, LIVER CIRRHOSIS, HEART | Adult patients aged ≥18 years with at least one blood culture positive for MSSA ≤ 72 h before randomization, with evidence of active infection, were considered eligible for inclusion in the study. Treatment with any anti-staphylococcal antibiotic ≤72 h preceding randomization was allowed. Exclusion criteria were severe... | PMC10579052 |
Randomization and masking | Participants were randomly assigned (1:1) to receive cloxacillin plus fosfomycin or cloxacillin alone, for the initial 7 days of treatment. A centralized electronic computer randomization schedule was developed by the Biostatistics Unit at the Bellvitge Biomedical Research Institute (IDIBELL). The randomization was per... | PMC10579052 | ||
Outcomes | bacteremia, infection, MSSA | ENDOCARDITIS, ADVERSE EVENTS, INFECTION, SECONDARY, STERILE | The primary study endpoint was treatment success at day 7, a composite endpoint defined as the presence of all of the following criteria: patient alive, stable or with improved qSOFA score compared with baseline, afebrile and with negative blood cultures for MSSA. The primary endpoint was adjudicated by an independent ... | PMC10579052 |
Statistical analysis | EVENTS, SECONDARY | On the basis of our own experienceData for the primary and secondary endpoints were analyzed with the intention-to-treat approach and per protocol. The intention-to-treat analysis included all randomly assigned patients who received at least one day of treatment. As the two analyses produced virtually the same results,... | PMC10579052 | |
Reporting summary | Further information on research design is available in the | PMC10579052 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02569-0. | PMC10579052 | ||
Supplementary information |
Reporting Summary | PMC10579052 | ||
Extended data | is available for this paper at 10.1038/s41591-023-02569-0. | PMC10579052 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02569-0. | PMC10579052 | ||
Acknowledgements | This study was funded by the Spanish Ministry of Health (grant no. PI17/01116), Instituto de Salud Carlos III, Madrid, Spain, and Laboratorios ERN, Barcelona, Spain (grant no. 19PNJ145). We thank the Spanish Clinical Research Network (SCReN), Instituto de Salud Carlos II, for its support through projects PT17/0017/0010... | PMC10579052 | ||
Author contributions | M.P. and J.C. were lead investigators. M.P., J.M.M. and J.C contributed to study design and development of concept. S.G., M.P. and J.C drafted the manuscript. N.P. and C.T performed statistical analysis. M.P. obtained funding. S.V., P.H., G.H., D.M., M.S., S.G., M.P., J.C., N.P. and C.T. had full access to all data in ... | PMC10579052 | ||
Peer review | PMC10579052 | |||
Data availability | SECONDARY | Individual patient data cannot be shared because of privacy restrictions. Raw anonymized data relating to primary and secondary outcomes and safety can be shared upon request. Depending on the data requested, we will need to consult with the institutional review board at Hospital Universitari de Bellvitge. Requests for... | PMC10579052 | |
Competing interests | M.P. received a research grant from Laboratorios ERN. J.M.M. has received consulting honoraria and/or research grants from Angelini Pharma, ContraFect, Genentech, Gilead Sciences, Janssen, Lysovant, Medtronic, Merck Sharp & Dohme (MSD), Novartis, Pfizer and ViiV Healthcare, outside the submitted work. J.L.C. has receiv... | PMC10579052 | ||
References | PMC10579052 | |||
Supplementary Information | hand movements | Pre-operative simulated practice allows trainees to learn robotic surgery outside the operating room without risking patient safety. While simulation practice has shown efficacy, simulators are expensive and frequently inaccessible. Cruff (J Surg Educ 78(2): 379–381, 2021) described a low-cost simulation model to learn... | PMC10492874 | |
Keywords | PMC10492874 | |||
Introduction | Robotic surgery is a positive, enduring innovation that surgeons are increasingly integrating into surgical practice for complex minimally invasive procedures [Various robotic surgery simulators currently are available, including the da Vinci Skills Simulator (dVSS; Intuitive Surgical Inc., Sunnydale, California, USA) ... | PMC10492874 | ||
Materials and methods | PMC10492874 | |||
Development of home simulation kits | foam suture | PAD | The controllers in the home simulation kits were designed to mimic the MTMs on the dVSS and were modeled from those described by Cruff [Home simulation kits including the hand controllers, peg transfer board, and spongeThe peg transfer board allowed trainees to practice an exercise that mimicked the Sea Spikes 1 task o... | PMC10492874 |
Study design and participants | Volunteer medical students who were novices to robotic surgery were recruited to participate in this study. The University of California, San Francisco (UCSF) Institutional Review Board determined this study to be exempt (IRB22-36266). All participants completed a pre-study survey on general demographics and factors th... | PMC10492874 | ||
Main study parameters | After each trial of a task, SimNow produces a score report that provides an overall score (out of 100) for the trainee’s performance. In addition to the overall score for each task, the score report is also broken up into various components. The pre-specified performance parameters examined in this study included: (1) ... | PMC10492874 | ||
Statistical analysis | Descriptive statistics regarding the demographics of the participants, including their year in medical school, gender, age, video game use, handedness, and experience in the OR, as well as with laparoscopic surgery and robotic surgery, were assessed using R version 4.1.3. The groups were compared on these demographics ... | PMC10492874 | ||
Qualitative interviews | SECONDARY | Following the second SimNow session, all the students from the experimental and control groups participated in semi-structured debriefing interviews with RW regarding their experience using the robotic surgery simulator during the first and second simulator sessions. As a medical student, RW was chosen to conduct the i... | PMC10492874 | |
Results | PMC10492874 | |||
Demographics | Overall, 33 participants completed the first dVSS session, of whom 29 participants completed both dVSS sessions (Fig. Participant demographics and baseline characteristics*Not calculated because sample size was too small to meet statistical assumptions | PMC10492874 | ||
Qualitative interviews | All 29 students who returned for the second robotic simulator session completed the post-session interview immediately following the second task. Through the participant interviews, we identified three main themes of student experience: (1) Novices encounter initial challenges with the robotic simulator that improve wi... | PMC10492874 | ||
Novices encounter initial challenges with the robotic simulator that improve with exposure | hand movements | Students experienced challenges upon initial exposure to the robotic simulator in three areas: (1) familiarity, (2) technical skills, and (3) visuospatial skills. These challenges framed subsequent experiences with home simulation.Many participants found it difficult to orient themselves to the robot and the tasks, as ... | PMC10492874 | |
Practice with the home simulation kit impacts the robotic simulator experience | Within the experimental group, participants attributed a variety of experiences during the second SimNow session to their practice with the home kit, including both technical skills and understanding of the robotic console.In terms of technical skills, participants felt that practicing needle manipulation with the cont... | PMC10492874 | ||
The fidelity of the home simulation kit could be improved | PAD | While participants found the home kits to be helpful in improving their skills and comfort with the robotic simulator, they also had some suggestions for refining the kits for future use. Their suggestions focused on model design transferability to the robotic simulator, as well as on the mechanical challenges they exp... | PMC10492874 | |
Discussion | Given the need to provide practice opportunities to prepare learners to use new surgical technologies, this study evaluated home practice for robotic surgery. Overall, low-cost robotic surgery home simulation kits did not lead students to better performance on dVSS compared to control students, though interview data hi... | PMC10492874 | ||
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 15 KB) | PMC10492874 | ||
Author contributions | All authors contributed to the study conception and design. The robotic surgery simulator sessions were run by RW, RB, and NR. Material preparation, data collection and analysis were performed by RW, RB, and PO’S. The first draft of the manuscript was written by RW and RB. All authors had substantial contributions to r... | PMC10492874 | ||
Funding | Rachel Wile received funding through UCSF’s Summer Explore Program. Riley Brian receives funding through the UCSF-Intuitive Simulation-Based Surgical Education Research Fellowship. Jason Cruff previously received a grant from Intuitive Surgical with plans to perform a similar research project at his home institution bu... | PMC10492874 | ||
Data availability | The data that support the findings of this study are available on request from the corresponding author, RW. | PMC10492874 | ||
Declarations | PMC10492874 | |||
Competing interests | The authors declare no competing interests. | PMC10492874 | ||
Ethical approval | The University of California, San Francisco (UCSF) Institutional Review Board determined this study to be exempt (IRB22-36266). | PMC10492874 | ||
Consent to participate | Informed consent was obtained from all individual participants included in the study. | PMC10492874 | ||
Consent to publish | All individual study participant data included in the manuscript has been anonymized. The manuscript contains no individual identifying details, images, or videos. | PMC10492874 | ||
References | PMC10492874 | |||
Background | depression, obsessive–compulsive disorder, anxiety, PCS neuropsychiatric symptoms | CORONAVIRUS DISEASE 2019, SYNDROME, DISORDERS | Shortly after the Coronavirus disease 2019 (COVID-19) pandemic, a considerable number of recovered patients reported persisting symptoms, especially neuropsychological manifestations, which were later named post-COVID syndrome (PCS). Immune dysregulation was suggested as one of the main mechanisms for PCS. Fluvoxamine,... | PMC10064948 |
Method | infectious disease, dyspnea, fatigue | INFECTIOUS DISEASE, SECONDARY, INFILTRATES | In this double-blind randomized clinical trial, we included confirmed mild to moderate COVID-19 outpatients using polymerase chain reaction (PCR) by an infectious disease specialist. The presence of severe COVID-19 symptoms was evaluated by the infectious disease specialist and included dyspnea, SpO2 < 94% on room air,... | PMC10064948 |
Results | Fatigue | We screened a total of 486 patients from March to June 2022. After 12 weeks, 42 patients receiving fluvoxamine and 43 patients receiving Placebo were evaluated for PCS. Patients had a mean age of 38.5 ± 14.1 and 48% of them were women. Fatigue was significantly lower in the fluvoxamine group ( | PMC10064948 | |
Conclusion | fatigue | We concluded that taking fluvoxamine during active COVID-19 can reduce the chance of fatigue but the advantage of fluvoxamine was not observed for other symptoms. Further studies are necessary to confirm these preliminary results. | PMC10064948 | |
Keywords | PMC10064948 | |||
Introduction | pneumonia, sleep disorders, fatigue, anxiety, inflammation, viral infection, microvascular thrombosis, infection, psychiatric, depression, obsessive–compulsive disorder | NEURODEGENERATION, PNEUMONIA, INFLAMMATION, DISEASE, VIRAL INFECTION, DISORDERS, INFECTION, CORONAVIRUS, PATHOLOGY, SEVERE ACUTE RESPIRATORY SYNDROME | In the last days of 2019, several cases of pneumonia of unknown etiology were reported to the World Health Organization (WHO) in Wuhan, China, which cause was confirmed to be of the Coronaviridae family a week later and is now called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [In a systematic review o... | PMC10064948 |
Methods | PMC10064948 | |||
Design and participants | infectious disease, dyspnea | INFECTIOUS DISEASE, INFILTRATES | This randomized clinical trial (RCT) was conducted at Besat hospital, a major referral center east of Tehran, Iran. We enrolled patients above 18 years old with confirmed COVID-19 referring to the infectious disease clinic of the hospital. The confirmation of COVID-19 diagnosis was performed using polymerase chain reac... | PMC10064948 |
Intervention | ADVERSE EFFECTS | Patients were randomized using permuted block randomization with blocks of 4, 6, and 8 then assigned 1:1 into two groups (A and B) to either receive fluvoxamine 100 mg tablet or a placebo daily orally for 10 days. We chose this regimen based on previous studies on the effect of fluvoxamine on COVID-19 patients and cons... | PMC10064948 | |
Primary outcome | fatigue | SYNDROME | The primary outcome of our study was the presence of fatigue as the most common manifestation of the post-COVID syndrome [ | PMC10064948 |
Secondary outcomes | confusion, myalgia, sleep disorder, anxiety, vertigo, aggression, dizziness, memory impairment, headache, depression, distorted taste and smell | SECONDARY | The secondary outcome was the presence of other PCS neuropsychological manifestations which were also evaluated 12 weeks after enrollment. Patients were examined for symptoms including headache, vertigo, confusion, memory impairment, poor concentration, sleep disorder, aggression, anxiety, depression, myalgia, distorte... | PMC10064948 |
Statistical analysis | fatigue | The required sample size was calculated using a formula by Chow et al. for superiority trials. Using type I error rate of 0.05, 40% power, 15% margin, and expected proportion of 50% for fatigue, the primary outcome in both groups was due to having no prior information on the effect of fluvoxamine on fatigue [ | PMC10064948 | |
Results | PMC10064948 | |||
Demographics | We screened a total of 486 patients from March 2022 to Jun 2022, of which 329 patients did not meet inclusion criteria and 57 patients declined to participate in our study. We finally enrolled 100 patients, 50 patients were assigned to fluvoxamine and 50 to Placebo. At 12 weeks of follow-up, 85 patients were eligible f... | PMC10064948 | ||
Secondary outcomes | depression | All other symptoms were less prevalent in patients taking fluvoxamine except for poor concentration (19% in fluvoxamine vs. 16.3% in placebo), Although none were significant. Most considerable one was depression (2.4% in fluvoxamine vs. 16.3% in placebo, | PMC10064948 | |
Discussion | shortness of breath, taste disorder, pneumonia, fatigue, infection, psychiatric, headache, depression, smell or | TASTE DISORDER, PNEUMONIA, DISEASE, INFECTION, ADVERSE EFFECTS | In this randomized clinical trial, we found out that fluvoxamine reduces the risk of developing fatigue, the most common complaint in PCS when taken during active COVID-19. As for other PCS neuropsychological manifestations, no significant differences were observed between fluvoxamine and placebo, albeit because our pr... | PMC10064948 |
Limitations | fatigue | SECONDARY | Our study has several potential limitations. First, although conducted in a major referral center, this is a single-center study only on the Iranian population with a relatively small sample size, therefore our findings should be regarded as preliminary. Second, due to worldwide COVID-19 vaccination, future candidates ... | PMC10064948 |
Acknowledgements | We acknowledge all healthcare workers involved in diagnosing and treating patients in Besat Hospital. | PMC10064948 | ||
Authors’ contributions | A. Ajam contributed to interpreting the data, draft writing, and final editing. A. Ranjbar Naeini contributed to research design and final editing. R. Hamidi Farahani contributed to the research design and revised it critically. The author(s) read and approved the final manuscript. | PMC10064948 | ||
Funding | All funding support was provided by the AJAUMS. | PMC10064948 | ||
Availability of data and materials | The dataset generated and analyzed in this study are available from the authors upon reasonable request. Please contact ali.ajam@outlook.com. | PMC10064948 | ||
Declarations | PMC10064948 | |||
Ethics approval and consent to participate | Informed consent was obtained from all study participants. The protocol of this study is by the 2013 Helsinki declaration and was approved by the Ethics Committee of AJA University of Medical Sciences (AJAUMS), Ethics ID: IR.AJAUMS.REC.1400.302. This RCT was registered in the Iranian registry of clinical trials (IRCT),... | PMC10064948 | ||
Consent for publication | Not applicable. | PMC10064948 | ||
Competing interests | The authors declare no competing interests. | PMC10064948 | ||
References | PMC10064948 | |||
Background: | Parkinson’s disease, PD | Multi-arm, multi-stage (MAMS) platform trials can accelerate the identification of disease-modifying treatments for Parkinson’s disease (PD) but there is no current consensus on the optimal outcome measures (OM) for this approach. | PMC10578294 | |
Objective: | PD | To provide an up-to-date inventory of OM for disease-modifying PD trials, and a framework for future selection of OM for such trials. | PMC10578294 | |
Methods: | Parkinson Disease, PD | PARKINSON DISEASE | As part of the Edmond J Safra Accelerating Clinical Trials in Parkinson Disease (EJS ACT-PD) initiative, an expert group with Patient and Public Involvement and Engagement (PPIE) representatives’ input reviewed and evaluated available evidence on OM for potential use in trials to delay progression of PD. Each OM was ra... | PMC10578294 |
Results: | cognitive, disability | DISEASE PROGRESSION, DISEASE | An extensive inventory of OM was created, divided into: general, motor and non-motor scales, diaries and fluctuation questionnaires, cognitive, disability and health-related quality of life, capability, quantitative motor, wearable and digital, combined, resource use, imaging and wet biomarkers, and milestone-based. A ... | PMC10578294 |
Conclusion: | PD | We present a range of OM, classified according to a transparent framework, to aid selection of OM for disease-modifying PD trials, whilst allowing for inclusion or re-classification of relevant OM as new evidence emerges. | PMC10578294 | |
INTRODUCTION | Parkinson Disease, Parkinson’s disease, PD | PARKINSON DISEASE | There is currently no proven intervention to delay the progression of Parkinson’s disease (PD). A number of novel and promising treatment approaches are being developed to address this and need to be tested in clinical trials. Multi-arm, multi-stage (MAMS) platform trials may help accelerate the identification of poten... | PMC10578294 |
DISCUSSION | PD | We here present an up-to-date inventory of outcome measures for disease-modifying trials in PD based on expert and PPIE consensus. This inventory and framework will be used to guide the decision to select the outcome measures of the EJS ACT-PD MAMS platform trial, based on their fulfilment of desired criteria for an en... | PMC10578294 | |
Conclusions | PD | With the above methodology, we have identified a broad range of outcome measures which can be potentially included in disease-modifying PD trials, and make recommendations for their inclusion as core, supplementary (for specific arms) and exploratory measures in the EJS ACT-PD MAMS initiative. For other MAMS initiative... | PMC10578294 | |
EJS ACT-PD CONSORTIUM MEMBERS | Additional EJS ACT-PD consortium members (further details are provided in the | PMC10578294 | ||
Supplementary Material | PMC10578294 | |||
Supplementary Material 1 | Click here for additional data file. | PMC10578294 | ||
Supplementary Material 2 | Click here for additional data file. | PMC10578294 | ||
ACKNOWLEDGMENTS | Parkinson’s Disease | This work was done as part of the Edmond J Safra Accelerating Clinical Trials in Parkinson’s Disease (EJS ACT-PD) Initiative, which is funded by the Edmond J Safra Foundation. | PMC10578294 | |
SUPPLEMENTARY MATERIAL | The supplementary material is available in the electronic version of this article: | PMC10578294 | ||
CONFLICT OF INTEREST | Nordisk, MTH, Parkinson’s Research Committee member, NINDS, BBS, Parkinson’s disease, PD, Parkinson’s, MDS COA | SECONDARY, FOUNDER, BRAIN | RSW has received speaking honoraria from GE Healthcare and a writing honorarium from Britannia. DVW reports consultancy and speaker fees from Bial and Britannia. MTH received payment for Advisory Board attendance/consultancy for Lundbeck, ESCAPE Bio, Evidera, Manus Neurodynamica, Biogen MA, CuraSen Therapeutics, Roche ... | PMC10578294 |
DATA AVAILABILITY | Data sharing is not applicable to this article as no datasets were generated or analyzed during this study. | PMC10578294 | ||
ADDITIONAL STATEMENT | For the purpose of open access, the author has applied a Creative Commons Attribution (CC BY) license to any Author Accepted Manuscript version arising from this submission. | PMC10578294 | ||
REFERENCES | PMC10578294 | |||
Subject terms | An HPMC-based nasal spray solution containing human IgG1 antibodies against SARS-CoV-2 (nasal antibody spray or NAS) was developed to strengthen COVID-19 management. NAS exhibited potent broadly neutralizing activities against SARS-CoV-2 with PVNT | PMC10511465 | ||
Introduction | SARS-CoV-2 infections | VIRUS, SARS-COV-2 INFECTION, SARS-COV-2 BREAKTHROUGH INFECTION | The enduring waves of SARS-CoV-2 breakthrough infections create a global impediment that requires additional measures beyond vaccination to mitigate this perpetual situation. SARS-CoV-2 is an RNA virus with the characteristic of multiple spike glycoproteins on its envelopeNasal Antibody Spray (NAS) is an HPMC-based nas... | PMC10511465 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.