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Author(s):  
Yen-Wei Chen ◽  
Wei-Chi Chiang ◽  
Chia-Ling Chang ◽  
Shih-Ming Lo ◽  
Ching-Yi Wu

Abstract Background Robot-assisted hand training has shown positive effects on promoting neuromuscular control. Since both robot-assisted therapy and task-oriented training are often used in post-stroke rehabilitation, we raised the question of whether two interventions engender differential effects in different domains. Methods The study was conducted using a randomized, two-period crossover design. Twenty-four chronic stroke survivors received a 12-session robot-assisted intervention followed by a 12-session task-oriented intervention or vice versa. A 1-month washout period between each intervention was implemented. Outcome measures were evaluated before the intervention, after the first 12-session intervention, and after the second 12-session intervention. Clinical assessments included Fugl-Meyer Assessment for Upper Extremity, Wolf Motor Function Test, Action Research Arm Test and Motor Activity Log. Results Our findings suggested that EMG-driven robot-assisted therapy was as effective as task-oriented training in terms of improving upper limbs functional performance in activity domain, and robot-assisted therapy was more effective in improving movement duration during functional tasks. Task-oriented training showed better improvement in body function domain and activity and participation domain, especially in improving spontaneous use of affected arm during daily activities. Conclusions Both intervention protocol had their own advantages in different domains, and robot-assisted therapy may save manpower and be considered as an alternative intervention to task-oriented training. Combining the two approaches could yield results greater than either alone, which awaits further study. Trial registration: ClinicalTrials.gov Identifier: NCT03624153. Registered on 9th August 2018, https://clinicaltrials.gov/ct2/show/NCT03624153.


2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Iichiro Sugita ◽  
Tomoichiro Ogawa ◽  
Kazuo Ichikawa ◽  
Takahide Okita ◽  
Kazuno Negishi ◽  
...  

Abstract Background To evaluate the safety and efficacy of a new toric intraocular lens (IOL) with anchor-wing haptics. Methods The new toric IOL with anchor-wing haptics (NS60YT, NIDEK Co., Ltd.) was implanted in eligible patients with age-related cataracts with preoperative corneal astigmatism of 1.0 D or greater at a university hospital and two private hospitals in Japan. The following IOL cylinder powers were evaluated: 1.50 D (NS60YT3), 2.25 D (NS60YT4), 3.00 D (NS60YT5) and 4.50 D (NS60YT7). All patients were assessed out to 12 months postoperatively. The primary endpoint was visual acuity (VA) with spherical addition at 6 months postoperatively, and the primary analysis calculated the proportion of eyes with VA with spherical addition of 0.1 logMAR or better. The magnitude of rotation was compared to the intended axis of IOL implantation at each postoperative examination. Adverse events were evaluated for the safety analysis. Results This study enrolled 64 eyes of 53 patients. At 6 months postoperatively, for all IOL powers, VA with spherical addition of 0.1 logMAR or better was achieved in 90% [95% confidence interval (CI): 80–96] of eyes. The mean IOL rotation was 5.3 ± 4.3° at 12 months postoperatively. The mean magnitude of rotation ranged from 1.9° to 2.5° between each postoperative examination from 1 day to 12 months. There were no vision-threatening intraoperative or postoperative complications for the duration of the study. Conclusions The NS60YT IOL remained stable after implantation and was efficacious for treating 1.00 D or greater astigmatism in patients with senile cataracts. Trial registration This study was registered at ClinicalTrials.gov (NCT03242486) on August 8, 2017 - Retrospectively registered.


2022 ◽  
Vol 11 (1) ◽  
Author(s):  
Yuelun Zhang ◽  
Siyu Liang ◽  
Yunying Feng ◽  
Qing Wang ◽  
Feng Sun ◽  
...  

Abstract Background Systematic review is an indispensable tool for optimal evidence collection and evaluation in evidence-based medicine. However, the explosive increase of the original literatures makes it difficult to accomplish critical appraisal and regular update. Artificial intelligence (AI) algorithms have been applied to automate the literature screening procedure in medical systematic reviews. In these studies, different algorithms were used and results with great variance were reported. It is therefore imperative to systematically review and analyse the developed automatic methods for literature screening and their effectiveness reported in current studies. Methods An electronic search will be conducted using PubMed, Embase, ACM Digital Library, and IEEE Xplore Digital Library databases, as well as literatures found through supplementary search in Google scholar, on automatic methods for literature screening in systematic reviews. Two reviewers will independently conduct the primary screening of the articles and data extraction, in which nonconformities will be solved by discussion with a methodologist. Data will be extracted from eligible studies, including the basic characteristics of study, the information of training set and validation set, and the function and performance of AI algorithms, and summarised in a table. The risk of bias and applicability of the eligible studies will be assessed by the two reviewers independently based on Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). Quantitative analyses, if appropriate, will also be performed. Discussion Automating systematic review process is of great help in reducing workload in evidence-based practice. Results from this systematic review will provide essential summary of the current development of AI algorithms for automatic literature screening in medical evidence synthesis and help to inspire further studies in this field. Systematic review registration PROSPERO CRD42020170815 (28 April 2020).


Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Tao Yuan ◽  
Hongyu He ◽  
Yuepeng Liu ◽  
Jianwei Wang ◽  
Xin Kang ◽  
...  

Abstract Background Blood glucose levels that are too high or too low after traumatic brain injury (TBI) negatively affect patient prognosis. This study aimed to demonstrate the relationship between blood glucose levels and the Glasgow Outcome Score (GOS) in TBI patients. Methods This study was based on a randomized, dual-center, open-label clinical trial. A total of 208 patients who participated in the randomized controlled trial were followed up for 5 years. Information on the disease, laboratory examination, insulin therapy, and surgery for patients with TBI was collected as candidate variables according to clinical importance. Additionally, data on 5-year and 6-month GOS were collected as primary and secondary outcomes, respectively. For multivariate analysis, a generalized additive model (GAM) was used to investigate relationships between blood glucose levels and GOS. The results are presented as odds ratios (ORs) with 95% confidence intervals (95% CIs). We further applied a two- piecewise linear regression model to examine the threshold effect of blood glucose level and GOS. Results A total of 182 patients were included in the final analysis. Multivariate GAM analysis revealed that a bell-shaped relationship existed between average blood glucose level and 5-year GOS score or 6-month GOS score. The inflection points of the average blood glucose level were 8.81 (95% CI: 7.43–9.48) mmol/L considering 5-year GOS as the outcome and were 8.88 (95% CI 7.43−9.74) mmol/L considering 6-month GOS score as the outcome. The same analysis revealed that there was also a bell relationship between average blood glucose levels and the favorable outcome group (GOS score ≥ 4) at 5 years or 6 months. Conclusion In a population of patients with traumatic brain injury, blood glucose levels were associated with the GOS. There was also a threshold effect between blood glucose levels and the GOS. A blood glucose level that is either too high or too low conveys a poor prognosis. Trial registration ClinicalTrials.gov NCT02161055. Registered on 11 June 2014.


BMC Cancer ◽  
2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Giuditta Chiloiro ◽  
Davide Cusumano ◽  
Luca Boldrini ◽  
Angela Romano ◽  
Lorenzo Placidi ◽  
...  

Abstract Background Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality in locally advanced rectal cancer (LARC). Since response to radiotherapy (RT) is dose dependent in rectal cancer, dose escalation may lead to higher complete response rates. The possibility to predict patients who will achieve complete response (CR) is fundamental. Recently, an early tumour regression index (ERI) was introduced to predict pathological CR (pCR) after nCRT in LARC patients. The primary endpoints will be the increase of CR rate and the evaluation of feasibility of delta radiomics-based predictive MRI guided Radiotherapy (MRgRT) model. Methods Patients affected by LARC cT2-3, N0-2 or cT4 for anal sphincter involvement N0-2a, M0 without high risk features will be enrolled in the trial. Neoadjuvant CRT will be administered using MRgRT. The initial RT treatment will consist in delivering 55 Gy in 25 fractions on Gross Tumor Volume (GTV) plus the corresponding mesorectum and 45 Gy in 25 fractions on the drainage nodes. Chemotherapy with 5-fluoracil (5-FU) or oral capecitabine will be administered continuously. A 0.35 Tesla MRI will be acquired at simulation and every day during MRgRT. At fraction 10, ERI will be calculated: if ERI will be inferior than 13.1, the patient will continue the original treatment; if ERI will be higher than 13.1 the treatment plan will be reoptimized, intensifying the dose to the residual tumor at the 11th fraction to reach 60.1 Gy. At the end of nCRT instrumental examinations are to be performed in order to restage patients. In case of stable disease or progression, the patient will undergo surgery. In case of major or complete clinical response, conservative approaches may be chosen. Patients will be followed up to evaluate toxicity and quality of life. The number of cases to be enrolled will be 63: all the patients will be treated at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Discussion This clinical trial investigates the impact of RT dose escalation in poor responder LARC patients identified using ERI, with the aim of increasing the probability of CR and consequently an organ preservation benefit in this group of patients. Trial registration ClinicalTrials.gov Identifier: NCT04815694 (25/03/2021).


2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Elena Rojano ◽  
Fernando M. Jabato ◽  
James R. Perkins ◽  
José Córdoba-Caballero ◽  
Federico García-Criado ◽  
...  

Abstract Background Protein function prediction remains a key challenge. Domain composition affects protein function. Here we present DomFun, a Ruby gem that uses associations between protein domains and functions, calculated using multiple indices based on tripartite network analysis. These domain-function associations are combined at the protein level, to generate protein-function predictions. Results We analysed 16 tripartite networks connecting homologous superfamily and FunFam domains from CATH-Gene3D with functional annotations from the three Gene Ontology (GO) sub-ontologies, KEGG, and Reactome. We validated the results using the CAFA 3 benchmark platform for GO annotation, finding that out of the multiple association metrics and domain datasets tested, Simpson index for FunFam domain-function associations combined with Stouffer’s method leads to the best performance in almost all scenarios. We also found that using FunFams led to better performance than superfamilies, and better results were found for GO molecular function compared to GO biological process terms. DomFun performed as well as the highest-performing method in certain CAFA 3 evaluation procedures in terms of $$F_{max}$$ F max and $$S_{min}$$ S min We also implemented our own benchmark procedure, Pathway Prediction Performance (PPP), which can be used to validate function prediction for additional annotations sources, such as KEGG and Reactome. Using PPP, we found similar results to those found with CAFA 3 for GO, moreover we found good performance for the other annotation sources. As with CAFA 3, Simpson index with Stouffer’s method led to the top performance in almost all scenarios. Conclusions DomFun shows competitive performance with other methods evaluated in CAFA 3 when predicting proteins function with GO, although results vary depending on the evaluation procedure. Through our own benchmark procedure, PPP, we have shown it can also make accurate predictions for KEGG and Reactome. It performs best when using FunFams, combining Simpson index derived domain-function associations using Stouffer’s method. The tool has been implemented so that it can be easily adapted to incorporate other protein features, such as domain data from other sources, amino acid k-mers and motifs. The DomFun Ruby gem is available from https://rubygems.org/gems/DomFun. Code maintained at https://github.com/ElenaRojano/DomFun. Validation procedure scripts can be found at https://github.com/ElenaRojano/DomFun_project.


2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Maciej J. K. Simon ◽  
Jennifer A. Coghlan ◽  
Jeff Hughes ◽  
Warwick Wright ◽  
Richard J. Dallalana ◽  
...  

Abstract Background In an anatomic shoulder replacement (aTSR) good results have been reported with the use of a stemless humeral prosthesis. In vitro a ceramic articulation with polyethylene has been shown to produce less polyethylene wear particles than with metal. This study aims to evaluate clinical and radiographic results of a stemless aTSR with a ceramic head articulating with a polyethylene glenoid component, with mid-term follow-up. Methods All patients (n = 92) in this prospective study had an aTSR utilizing a stemless humeral component with a ceramic head and a cemented double pegged cemented polyethylene glenoid component for glenohumeral osteoarthritis. Pre- and postoperative clinical evaluations at 2 years were performed using the ASES score, Constant score, SPADI score, DASH score, VAS pain score, patient satisfaction and range of motion. There was a 5-year evaluation of SPADI, ASES, pain, and satisfaction, plus radiographic assessment of glenoid component radiolucent lines and humeral osteolysis. Results Seventy-four cases (68.1 ± 7.1 years) had a five-year follow-up and demonstrated active elevation improvement from 91.3° preoperatively to 151.1° (p < 0.001). Further improvement was identified with the ASES from 41.6 to 94.3, the SPADI from 62.9 to 4.3, VAS pain from 5.6 to 0.4 (0–10), and satisfaction levels were at 96%. Sixty-two cases had no glenoid radiolucent lines with a maximum Lazarus score of 2 in one patient. Constant scores, available up to 2 years, improved significantly from 30.3 to 77.9 (p < 0.001). There was one case that required revision for glenoid loosening. Conclusions Overall, the 5-year results of this ceramic head prosthesis demonstrated good radiographic and clinical outcomes. Trial registration ACTRN12613001183774. Registered: 29 October 2013 - Retrospectively registered. Australian New Zealand Clinical Trials Registry (ANZCTR).


2022 ◽  
Vol 22 (1) ◽  
Author(s):  
Mariko Hojo ◽  
Daisuke Asaoka ◽  
Yuji Shimada ◽  
Shuko Nojiri ◽  
Akihito Nagahara

Abstract Background Proton pump inhibitors (PPIs), including potassium ion-competitive acid blocker, are widely used worldwide and are often used for long periods of time. However, in recent years, potential side effects associated with long-term PPI use have been reported. Many patients take PPI for a long period of time, even though it is unnecessary, and it is necessary to discontinue PPI administration in such patients. However, sudden discontinuation may cause symptoms to recur and discontinuation may be unsuccessful. A strategy for safe and secure PPI discontinuation has not yet been established. The purpose of this study is to determine whether PPI can be safely discontinued by tapering the PPI dose or by abrupt discontinuation of PPI, and to establish a strategy for safe and secure PPI discontinuation. Methods The evaluation will be conducted as a multicenter, randomized, parallel-group clinical trial with five assessment points at the start of the study and 2 weeks, 4 weeks, 6 months, and 12 months after the start of the study. One intervention group is the group in which PPI administration is abruptly discontinued (Group A), and the second group is the group in which the PPI dose is gradually tapered and then PPI administration is discontinued (Group B). The primary outcome and secondary outcome are the proportion of patients who successfully discontinued the PPI at 6 months and at 12 months after the start of the study in groups A and B, respectively. Discussion We predict that the proportion of patients who successfully discontinue PPI will be higher in the group in which PPI administration was gradually tapered than in the group in which PPI administration was abruptly discontinued. On the other hand, we expect that many participants will succeed in discontinuing PPI regardless of the discontinuation strategy due to the explanation that discontinuation is necessary. Trial registration Japan Registry of Clinical Trials, jRCT1031180383. Registered 20 March 2019, https://jrct.niph.go.jp/latest-detail/jRCT1031180383.


Author(s):  
Tapio Helin ◽  
Remo Kretschmann

AbstractIn this paper we study properties of the Laplace approximation of the posterior distribution arising in nonlinear Bayesian inverse problems. Our work is motivated by Schillings et al. (Numer Math 145:915–971, 2020. 10.1007/s00211-020-01131-1), where it is shown that in such a setting the Laplace approximation error in Hellinger distance converges to zero in the order of the noise level. Here, we prove novel error estimates for a given noise level that also quantify the effect due to the nonlinearity of the forward mapping and the dimension of the problem. In particular, we are interested in settings in which a linear forward mapping is perturbed by a small nonlinear mapping. Our results indicate that in this case, the Laplace approximation error is of the size of the perturbation. The paper provides insight into Bayesian inference in nonlinear inverse problems, where linearization of the forward mapping has suitable approximation properties.


Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Sua Jo ◽  
Hyeyeon Moon ◽  
Kyungil Park ◽  
Chang-Bae Sohn ◽  
Jeonghwan Kim ◽  
...  

Abstract Background Dilated cardiomyopathy (DCMP) is characterized by ventricular chamber enlargement and systolic dysfunction which may cause heart failure. Patients with DCMP have overactivation of the renin-angiotensin-aldosterone systems, which can also adversely affect myocardial metabolism in heart failure. The impairment of myocardial metabolism can contribute to the progression of left ventricular remodeling and contractile dysfunction in heart failure. Although angiotensin II receptor blockers (ARBs) have been used to treat patients with DCMP, there has been no direct comparison of the efficacy of these agents. The objective of this study is to compare the effects of olmesartan and valsartan on myocardial metabolism in patients with DCMP. Methods/design The OVOID study (a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy) is designed as a non-blinded, open-label, parallel-group, prospective, randomized, controlled, multicenter clinical trial. A total of 40 DCMP patients aged between 20 and 85 years will be randomly allocated into the olmesartan or the valsartan group. 18F-fluoro-2-deoxyglucose (FDG) cardiac positron emission tomography (PET) will be performed at baseline and six months after receiving the study agent. The primary endpoint is myocardial glucose consumption per square meter, measured using 18F-FDG PET 6 months after receiving the study agent. Discussion The purpose of this trial is to compare the efficacy between olmesartan and valsartan in improving myocardial metabolism in DCMP patients. This will be the first randomized comparative study investigating the differential effects of ARBs on heart failure. Trial registration ClinicalTrials.govNCT04174456. Registered on 18 November 2019


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