Clinical Trial
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James L. Cook ◽  
Kylee Rucinski ◽  
Cory R. Crecelius ◽  
Suzin Cunningham ◽  
Trent M. Guess

AbstractThis prospective randomized clinical trial assessed a novel device for initial management of knee range of motion (ROM), pain, and function after total knee arthroplasty (TKA). Primary TKA patients with preoperative ROM of at least 5° to 115° were randomized to initial knee motion management: Mizzou BioJoint Flex—novel motion-assistive device with prescribed physical therapy or standard physical therapy—prescribed physical therapy. ROM, pain score, and knee injury and osteoarthritis score for joint replacement (KOOSjr) were obtained preoperatively and 2 weeks, 6 weeks, and 3 months postoperatively. Patient satisfaction for both cohorts and subjective assessments of the MBF device were assessed at 3 months. Readmissions, reoperations, and complications were assessed through 1 year. Nineteen patients were randomized to each cohort, with no significant preoperative differences in demographics, pain score, KOOSjr score, or ROM. Six SPT (31.6%) and 3 MBF (15.8%) patients failed to regain preoperative ROM (p = 0.044). One SPT (5.3%) and eight MBF (42%) patients exceeded 125° ROM (p = 0.019) by 3 months. Total ROM (p = 0.039), pain (p = 0.0068), and function (p = 0.0027) were significantly better for MBF at 3 months. MBF patients reported significantly higher satisfaction (mean, 9.4 ± 1.1 vs. 8.0 ± 1.8, respectively; p = 0.0084). One patient in each group underwent manipulation under anesthesia. No other readmissions, reoperations, or complications were reported. A novel durable medical equipment device can provide a safe and effective patient-controlled method for initial management of knee ROM, pain, and function after primary TKA with potential clinically meaningful advantages over physical therapy alone. In conjunction with physical therapy, management with this novel knee flexion device more effectively restored knee ROM and early patient function when compared with therapy alone and was associated with higher proportions of patients regaining minimum (115°) and desired (125°) levels of knee ROM and clinically meaningful differences in pain scores, knee function, and patient satisfaction. This is a Level 1, prospective trial study.

2021 ◽  
Jens Peter Klussmann ◽  
Clara Lehmann ◽  
Maria Grosheva ◽  
Kurtulus Sahin ◽  
Eszter Nagy ◽  

Abstract Background:The current COVID-19 pandemic has had a major influence on our daily lives. The most frequent early symptoms associated with SARS-CoV-2 infection are coughing, fever, rhinitis, and loss of smell and taste. If the infection progresses to the lower respiratory tract, it can cause massive inflammation of the pulmonary system, which can be life threatening. There is urgent need for a broadly available and effective therapy for the treatment of early infections with SARS-CoV-2 in order to prevent progression to severe disease. Methodology:CARVIN is a phase II proof of concept, randomized, parallel, double-blind, placebo-controlled, interventional clinical trial. 90 SARS-CoV-2 positive volunteers were randomized into three groups to receive either placebo, azelastine 0.02% or azelastine 0.1% nasal spray for a period of 11 days. Seven nasopharyngeal swabs were taken during this period for quantitative PCR measurements assessing the viral load via the ORF 1a/b and E genes. Investigators also assessed patients’ status continuously throughout the trial, and the intensity of individual symptoms were reported by the patients using an electronic diary. Two safety follow-ups were performed at days 16 and 60 of study participation. Results:Since the data of the primary outcome did not show a normal distribution, all statistical tests presented here were done non-parametrically and all p-values are descriptive and without adjustment for multiple testing. A broader descriptive analysis will be performed at a later date on all variables and it will be published in a peer-reviewed publication. A wide range of initial viral loads in the nasopharyngeal swabs of the study population was observed with an overall median/mean + SD Ct value of approximately 21.9 / 23.6 + 5.8, corresponding to log10 6.6 + 1.8 copies per /ml. Out of the 90 enrolled subjects, at least 54 carried the Alpha (B.1.1.7, UK) variant.Treatment with azelastine nasal sprays resulted in a greater but non-significant decrease in mean viral load compared to that measured in the placebo group at all 6 timepoints after initiation of treatment. This tendency was stable and most pronounced on day 8 (after 7 days treatment), when in the 0.1% and 0.02% azelastine nasal spray groups, an approximately 8- and 29-fold greater clinically meaningful reduction of the baseline viral load, respectively, compared to placebo was observed (based on the ORF1a/b gene). On days 4 and 11, approximately 4-fold greater mean viral load reduction was seen in the 0.1% azelastine group.Differences in mean viral load compared to baseline values were seen starting on the second day (after one day of treatment) in the azelastine 0.1% and azelastine 0.02% group for ORF 1a/b gene, and with azelastine 0.1% for the E gene, while this reduction was less pronounced in the placebo group.The effects of 0.1% azelastine nasal spray treatment to accelerate viral load reduction were even more pronounced in patients with initial high viral load (subgroup analyses in patients exhibiting initial Ct values below 25 and below 20, respectively). Of note, by day 8 the PCR-test had turned negative in more patients in the 0.1% azelastine group (n=6, p= 0.01 for the ORF 1a/b gene and n = 3, p= 0.08 for the E gene) and in the 0.02% azelastine group (n=8, p< 0.01 for the ORF 1a/b gene and n = 5, p= 0.02 for the E gene) than in the placebo group (n=0 for the ORF 1a/b gene and n = 0, for the E gene).Discussion:This study provides the first clinical hints of the effects of an azelastine nasal spray in SARS-CoV-2 positive patients. Subgroup analyses performed in patients exhibiting high initial viral loads are further suggestive of azelastine’s potential as an antiviral treatment.

2021 ◽  
Vol 8 ◽  
Chen Zhao ◽  
Li Li ◽  
Wei Yang ◽  
Wenliang Lv ◽  
Jian Wang ◽  

Background: Previous research suggested that Chinese Medicine (CM) Formula Huashibaidu granule might shorten the disease course in coronavirus disease 2019 (COVID-19) patients. This research aimed to investigate the early treatment effect of Huashibaidu granule in well-managed patients with mild COVID-19.Methods: An unblinded cluster-randomized clinical trial was conducted at the Dongxihu FangCang hospital. Two cabins were randomly allocated to a CM or control group, with 204 mild COVID-19 participants in each cabin. All participants received conventional treatment over a 7 day period, while the ones in CM group were additionally given Huashibaidu granule 10 g twice daily. Participants were followed up to their clinical endpoint. The primary outcome was worsening symptoms before the clinical endpoint. The secondary outcomes were cure and discharge before the clinical endpoint and alleviation of composite symptoms after the 7 days of treatment.Results: All 408 participants were followed up to their clinical endpoint and included in statistical analysis. Baseline characteristics were comparable between the two groups (P &gt; 0.05). The number of worsening patients in the CM group was 5 (2.5%), and that in the control group was 16 (7.8%) with a significant difference between groups (P = 0.014). Eight foreseeable mild adverse events occurred without statistical difference between groups (P = 0.151).Conclusion: Seven days of early treatment with Huashibaidu granule reduced the likelihood of worsening symptoms in patients with mild COVID-19. Our study supports Huashibaidu granule as an active option for early treatment of mild COVID-19 in similar well-managed medical environments.Clinical Trial, identifier: ChiCTR2000029763.

2021 ◽  
Junhong Chen ◽  
Ran Zhuo ◽  
Jiayan Chen ◽  
Adeline Yang ◽  
Ee Woon Lim ◽  

Abstract Objectives: Myopia is a major public health problem and it is essential to find safe and effective means to control its progression. The study design and baseline data are presented for a one-year prospective, double-masked, cross-over, randomized clinical trial evaluating the efficacy of single vision spectacle lenses with concentric rings of slightly aspherical contiguous lenslets technology (SAL) on myopia control. Methods: One hundred 8- to 13-year old Chinese children with a refractive error of -0.75 D to -4.75 D were assigned into two groups. In Group 1, SAL then single vision lenses were each worn for 6 months, and Group 2 wore the lenses in the reversed order. Primary outcomes are axial length and spherical equivalent of cycloplegic refractive error. Secondary outcomes include corneal thickness, anterior chamber depth, lens thickness, visual acuity, and lens adaptation.Results: No significant differences in baseline parameters (cycloplegic spherical equivalent, axial length, age) were found between groups (0.49 < p < 0.94). All children adapted well to the test lenses and there was no significant difference in visual acuity between the SAL and single vision lenses (p = 0.27).Conclusions: The children in the two well balanced groups had comparable visual acuity and adapted well to the test lenses. These results imply the visual acuity can be well improved by SAL lens. Clear visual acuity provide the assurance for good compliance in this longitudinal study.

2021 ◽  
Emanuella Silva Joventino Melo ◽  
Brena Shellem Bessa Oliveira ◽  
Francisca Mayra de Sousa Melo ◽  
Maria Jocelane Nascimento Silva ◽  
Rhaiany Kelly Lopes Oliveira ◽  

2021 ◽  
Vol 8 ◽  
Xuyan Li ◽  
Ming Hu ◽  
Ruiqiang Zheng ◽  
Yishan Wang ◽  
Hanyujie Kang ◽  

Background: Extracorporeal membrane oxygenation (ECMO) is a rapidly evolving therapy for acute lung and/or heart failure. However, the information on the application of ECMO in severe coronavirus disease 2019 (COVID-19) is limited, such as the initiation time. Especially in the period and regions of ECMO instrument shortage, not all the listed patients could be treated with ECMO in time. This study aimed to investigate and clarify the timing of ECMO initiation related to the outcomes of severe patients with COVID-19. The results show that ECMO should be initiated within 24 h after the criteria are met.Methods: In this retrospective, multicenter cohort study, we enrolled all ECMO patients with confirmed COVID-19 at the three hospitals between December 29, 2019 and April 5, 2020. Data on the demographics, clinical presentation, laboratory profile, clinical course, treatments, complications, and outcomes were collected. The primary outcomes were successful ECMO weaning rate and 60-day mortality after ECMO. Successful weaning from ECMO means that the condition of patients improved with adequate oxygenation and gas exchange, as shown by the vital signs, blood gases, and chest X-ray, and the patient was weaned from ECMO for at least 48 h.Results: A total of 31 patients were included in the analysis. The 60-day mortality rate after ECMO was 71%, and the ECMO weaning rate was 26%. Patients were divided into a delayed ECMO group [3 (interquartile range (IQR), 2–5) days] and an early ECMO group [0.5 (IQR, 0–1) days] based on the time between meeting the ECMO criteria and ECMO initiation. In this study, 14 and 17 patients were included in the early and delayed treatment groups, respectively. Early initiation of ECMO was associated with decreased 60-day mortality after ECMO (50 vs. 88%, P = 0.044) and an increased ECMO weaning rate (50 vs. 6%, P = 0.011).Conclusions: In ECMO-supported patients with COVID-19, delayed initiation of ECMO is a risk factor associated with a poorer outcome.Trial Registration: Clinical trial submission: March 19, 2020. Registry name: A medical records-based study for the clinical application of extracorporeal membrane oxygenation in the treatment of severe respiratory failure patients with novel coronavirus pneumonia (COVID-19). Chinese Clinical Trial Registry:,identifier:~ChiCTR2000030947.

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