Recovery rate of children with moderate acute malnutrition treated with ready-to-use supplementary food (RUSF) or improved corn–soya blend (CSB+): a randomized controlled trial

AbstractObjectiveTo compare an improved corn–soya blend (CSB+) with a ready-to-use supplementary food (RUSF) to test the hypothesis that satisfactory recovery rate will be achieved with CSB+ or RUSF when these foods provide 50 % of the child’s energy requirement, the 50 % remaining coming from usual diet.DesignA comparative efficacy trial study was conducted with moderately wasted children, using a controlled randomized design, with parallel assignment for RUSF or CSB+. Every child received a daily ration of 167 kJ (40 kcal)/kg body weight during 56 d with a follow-up performed every 14 d. Every caregiver received nutrition counselling at enrolment and at each follow-up visit.SettingHealth districts of Mvog-Beti and Evodoula in the Centre region of Cameroon.SubjectsEight hundred and thirty-three children aged 6–59 months were screened and eighty-one malnourished children (weight-for-height Z-score between −3 and −2) aged 25–59 months were selected.ResultsOf children treated with CSB+ and RUSF, 73 % (95 % CI 59 %, 87 %) and 85 % (95 % CI 73 %, 97 %), respectively, recovered from moderate acute malnutrition, with no significant difference between groups. The mean duration of treatment required to achieve recovery was 44 d in the RUSF group and 51 d in the CSB+ group (log-rank test, P=0·0048).ConclusionsThere was no significant difference in recovery rate between the groups. Both CSB+ and RUSF were relatively successful for the treatment of moderate acute malnutrition in children. Despite the relatively low ration size provided, the recovery rates observed for both groups were comparable to or higher than those reported in previous studies, a probable effect of nutrition education.

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The Relationship between Serum Ferritin Levels and 5-Year All-Cause Mortality in Hemodialysis Patients

Blood Purification ◽

10.1159/000515639 ◽

2021 ◽

pp. 1-7

Author(s):

Emre Erdem ◽

Ahmet Karatas ◽

Tevfik Ecder

Keyword(s):

Serum Ferritin ◽

Hemodialysis Patients ◽

Rank Test ◽

Significant Difference ◽

All Cause Mortality ◽

Group 3 ◽

Group 2 ◽

The Relationship ◽

Group 1

Introduction: The effect of high serum ferritin levels on long-term mortality in hemodialysis patients is unknown. The relationship between serum ferritin levels and 5-year all-cause mortality in hemodialysis patients was investigated in this study. Methods: A total of 173 prevalent hemodialysis patients were included in this study. The patients were followed for up to 5 years and divided into 3 groups according to time-averaged serum ferritin levels (group 1: serum ferritin <800 ng/mL, group 2: serum ferritin 800–1,500 ng/mL, and group 3: serum ferritin >1,500 ng/mL). Along with the serum ferritin levels, other clinical and laboratory variables that may affect mortality were also included in the Cox proportional-hazards regression analysis. Results: Eighty-one (47%) patients died during the 5-year follow-up period. The median follow-up time was 38 (17.5–60) months. The 5-year survival rates of groups 1, 2, and 3 were 44, 64, and 27%, respectively. In group 3, the survival was lower than in groups 1 and 2 (log-rank test, p = 0.002). In group 1, the mortality was significantly lower than in group 3 (HR [95% CI]: 0.16 [0.05–0.49]; p = 0.001). In group 2, the mortality was also lower than in group 3 (HR [95% CI]: 0.32 [0.12–0.88]; p = 0.026). No significant difference in mortality between groups 1 and 2 was found (HR [95% CI]: 0.49 [0.23–1.04]; p = 0.063). Conclusion: Time-averaged serum ferritin levels >1,500 ng/mL in hemodialysis patients are associated with an increased 5-year all-cause mortality risk.

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Randomized Controlled Trial of the Clinical Recovery and Biodegradation of Polylactide-co-glycolide Implants Used in the Intramedullary Nailing of Children’s Forearm Shaft Fractures with at Least Four Years of Follow-Up

Journal of Clinical Medicine ◽

10.3390/jcm10050995 ◽

2021 ◽

Vol 10 (5) ◽

pp. 995

Author(s):

Marja Perhomaa ◽

Tytti Pokka ◽

Linda Korhonen ◽

Antti Kyrö ◽

Jaakko Niinimäki ◽

...

Keyword(s):

Intramedullary Nailing ◽

Controlled Trial ◽

Long Term Outcomes ◽

Intramedullary Nails ◽

Metal Implants ◽

Shaft Fractures ◽

Fractures In Children ◽

Significant Difference

The preferred surgical fixation of forearm shaft fractures in children is Elastic Stable Intramedullary Nailing (ESIN). Due to known disadvantageous effects of metal implants, a new surgical method using biodegradable polylactide-co-glycolide (PLGA) intramedullary nails has been developed but its long-term outcomes are unclear. The aim of this study was to compare the long-term outcomes of Biodegradable Intramedullary Nailing (BIN) to ESIN and assess the biodegradation of the study implants via magnetic resonance imaging (MRI). The study population of the prospective, randomized trial consisted of paediatric patients whose forearm shaft fractures were treated with BIN (n = 19) or ESIN (n = 16). Forearm rotation at minimally four years’ follow-up was the main outcome. There was no clinically significant difference in the recovery of the patients treated with the BIN as compared to those treated with the ESIN. More than half of the implants (57.7%, n = 15/26) were completely degraded, and the rest were degraded almost completely. The PLGA intramedullary nails used in the treatment of forearm shaft fractures in this study resulted in good function and anatomy. No unexpected disadvantages were found in the degradation of the implants. However, two implant failures had occurred in three months postoperatively.

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The Efficacy of Etoposide-Based Therapy in Adult Secondary Hemophagocytic Lymphohistiocytosis

Acta Haematologica ◽

10.1159/000514920 ◽

2021 ◽

pp. 1-9

Author(s):

Leonard Naymagon ◽

Douglas Tremblay ◽

John Mascarenhas

Keyword(s):

Hemophagocytic Lymphohistiocytosis ◽

Proportional Hazards ◽

Multivariable Analysis ◽

Cox Proportional Hazards ◽

Rank Test ◽

Kaplan Meier ◽

Hazard Ratios ◽

Significant Difference ◽

The Impact

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank p = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, p = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.

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Capsular closure versus unrepaired interportal capsulotomy after hip arthroscopy in patients with femoroacetabular impingement, results of a patient-blinded randomised controlled trial

Hip International ◽

10.1177/11207000211005762 ◽

2021 ◽

pp. 112070002110057

Author(s):

Niels H Bech ◽

Inger N Sierevelt ◽

Sheryl de Waard ◽

Boudijn S H Joling ◽

Gino M M J Kerkhoffs ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Femoroacetabular Impingement ◽

Hip Arthroscopy ◽

Controlled Trial ◽

Poor Quality ◽

Control Group ◽

Treatment Groups ◽

Significant Difference ◽

Randomised Controlled

Background: Hip capsular management after hip arthroscopy remains a topic of debate. Most available current literature is of poor quality and are retrospective or cohort studies. As of today, no clear consensus exists on capsular management after hip arthroscopy. Purpose: To evaluate the effect of routine capsular closure versus unrepaired capsulotomy after interportal capsulotomy measured with NRS pain and the Copenhagen Hip and Groin Outcome Score (HAGOS). Materials and methods: All eligible patients with femoroacetabular impingement who opt for hip arthroscopy ( n = 116) were randomly assigned to one of both treatment groups and were operated by a single surgeon. Postoperative pain was measured with the NRS score weekly the first 12 weeks after surgery. The HAGOS questionnaire was measured at 12 and 52 weeks postoperatively. Results: Baseline characteristics and operation details were comparable between treatment groups. Regarding the NRS pain no significant difference was found between groups at any point the first 12 weeks after surgery ( p = 0.67). Both groups significantly improved after surgery ( p < 0.001). After 3 months follow-up there were no differences between groups for the HAGOS questionnaire except for the domain sport ( p = 0.02) in favour of the control group. After 12 months follow-up there were no differences between both treatment groups on all HAGOS domains ( p > 0.05). Conclusions: The results of this randomised controlled trial show highest possible evidence that there is no reason for routinely capsular closure after interportal capsulotomy at the end of hip arthroscopy. Trial Registration: This trial was registered at the CCMO Dutch Trial Register: NL55669.048.15.

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Open versus arthroscopic release for lateral patellar compression syndrome: a randomized-controlled trial

Archives of Orthopaedic and Trauma Surgery ◽

10.1007/s00402-021-03878-0 ◽

2021 ◽

Author(s):

Sherwan A. Hamawandi ◽

Hazhar I. Amin ◽

Ameer Kadhim Al-Humairi

Keyword(s):

Functional Outcome ◽

Patellar Instability ◽

Controlled Trial ◽

Lateral Release ◽

Open Release ◽

Arthroscopic Release ◽

Compression Syndrome ◽

Significant Difference ◽

Lateral Patellar Compression Syndrome

Abstract Introduction Lateral patellar compression syndrome is one of the causes of anterior knee pain in young adults and resulted from tight lateral patellar retinaculum. The aim of our study is to compare between open and arthroscopic release of lateral patellar compression syndrome in relation of functional outcome, time of surgical procedure, length of hospital stays, intraoperative and postoperative complications as bleeding, infection, recurrence, and patellar instability with 2 years of follow-up. Materials and methods 80 patients, age (21–49 years), were divided randomly into 2 groups (A and B). Group A (40 patients) were treated with open release. Group B (40 patients) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features and MRI. All patients were assessed by Lysholm knee scoring scale before surgery and at periods of 2, 6 weeks, 6, 12, and 24 months after surgery. Results There is significant difference in functional outcome, measured by Lysholm knee scoring scale, between preoperative and postoperative assessment periods in both groups (P < 0.001). There is significantly better functional outcome at 2 years of follow-up with arthroscopic release (P = 0.018). There is no recurrence in both groups, but there were 4 patients develop medial patellar instability in the group of open release. Conclusion Both open and arthroscopic lateral release for patients with isolated lateral patellar compression syndrome can be effective surgical procedures, but arthroscopic release can achieve better functional outcome. Trial registration: NCT, NCT04130412. Retrospectively registered on 3rd of June, 2020 at ClinicalTrials.gov.

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Comparing Zirconia to Anterior Strip Crowns in Primary Anterior Teeth in children, A Randomized Clinical Trial

10.21203/rs.3.rs-38319/v4 ◽

2020 ◽

Author(s):

Sumer M Alaki ◽

Bashaer S Abdulhadi ◽

Medhat A AbdelBaki ◽

Najla M Al-Alamoudi

Keyword(s):

Resin Composite ◽

Rank Test ◽

Random Allocation ◽

Tooth Structure ◽

Anterior Teeth ◽

Gingival Health ◽

Significant Difference ◽

Zirconia Crowns ◽

Restoration Failure

Abstract Background: Providing restorations to anterior teeth in children is a challenging task due to the need for high esthetics, strength, and durability. This study was done to compare prefabricated primary zirconia with resin composite strip crowns on primary maxillary central and lateral incisors with regards to gingival health, plaque accumulation, recurrent caries, restoration failure, and opposing teeth wear over a period of 3, 6 and 12 months. Methods: Children attending the King Abdulaziz University, Faculty of Dentistry (KAUFD) clinics who needed restorations were screened for inclusion criteria. A total of 120 teeth were treated; 60 with zirconia and 60 with strip crowns. Randomization was done by simple random allocation using SPSS software version 20.0 (Armonk, NY; IBM Corp.). A simple descriptive statistic was used for analysis by Wilcoxon Signed-Rank test and Chi-square test. Level of significance was set at (α = 0.05) and level of confidence at (95%). The presented research was registered retrospectively at ClinicalTrials.gov in 6th of August 2017, under registration number NCT03184012.Results: Zirconia crowns showed significantly less gingival bleeding at the 3- and 6-months follow up periods (p<0.006, p<0.001; respectively), less plaque accumulation at all follow up visits (p<0.001), no restoration failure (p<0.001), but more wear to opposing teeth (p<0.02). No significant difference was found between the two crowns with regards to recurrent caries (p<0.135).Conclusion: Based on our data we conclude that overtime teeth covered with zirconia crowns show better gingival health and less bleeding, plaque accumulation as well as less loss of material. On the other hand, zirconia can cause more loss of opposing tooth structure.

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Clinical Outcomes of Computational Virtual Mapping-Guided Catheter Ablation in Patients With Persistent Atrial Fibrillation: A Multicenter Prospective Randomized Clinical Trial

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.772665 ◽

2021 ◽

Vol 8 ◽

Author(s):

Yong-Soo Baek ◽

Oh-Seok Kwon ◽

Byounghyun Lim ◽

Song-Yi Yang ◽

Je-Wook Park ◽

...

Keyword(s):

Atrial Fibrillation ◽

Clinical Trial ◽

Catheter Ablation ◽

Computational Modeling ◽

Controlled Trial ◽

Dominant Frequency ◽

Complication Rates ◽

Clinical Recurrence ◽

Significant Difference

Background: Clinical recurrence after atrial fibrillation catheter ablation (AFCA) still remains high in patients with persistent AF (PeAF). We investigated whether an extra-pulmonary vein (PV) ablation targeting the dominant frequency (DF) extracted from electroanatomical map–integrated AF computational modeling improves the AFCA rhythm outcome in patients with PeAF.Methods: In this open-label, randomized, multi-center, controlled trial, 170 patients with PeAF were randomized at a 1:1 ratio to the computational modeling-guided virtual DF (V-DF) ablation and empirical PV isolation (E-PVI) groups. We generated a virtual dominant frequency (DF) map based on the atrial substrate map obtained during the clinical AF ablation procedure using computational modeling. This simulation was possible within the time of the PVI procedure. V-DF group underwent extra-PV V-DF ablation in addition to PVI, but DF information was not notified to the operators from the core lab in the E-PVI group.Results: After a mean follow-up period of 16.3 ± 5.3 months, the clinical recurrence rate was significantly lower in the V-DF than with E-PVI group (P = 0.018, log-rank). Recurrences appearing as atrial tachycardias (P = 0.145) and the cardioversion rates (P = 0.362) did not significantly differ between the groups. At the final follow-up, sinus rhythm was maintained without any AADs in 74.7% in the V-DF group and 48.2% in the E-PVI group (P < 0.001). No significant difference was found in the major complication rates (P = 0.489) or total procedure time (P = 0.513) between the groups. The V-DF ablation was independently associated with a reduced AF recurrence after AFCA [hazard ratio: 0.51 (95% confidence interval: 0.30–0.88); P = 0.016].Conclusions: The computational modeling-guided V-DF ablation improved the rhythm outcome of AFCA in patients with PeAF.Clinical Trial Registration: Clinical Research Information Service, CRIS identifier: KCT0003613.

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Enisamium is an inhibitor of the SARS-CoV-2 RNA polymerase and shows improvement of recovery in COVID-19 patients in an interim analysis of a clinical trial

10.1101/2021.01.05.21249237 ◽

2021 ◽

Author(s):

Olha Holubovska ◽

Denisa Bojkova ◽

Stefano Elli ◽

Marco Bechtel ◽

David Boltz ◽

...

Keyword(s):

Rna Polymerase ◽

Medical Care ◽

Interim Analysis ◽

Influenza A ◽

Controlled Trial ◽

Rank Test ◽

Supplementary Oxygen ◽

Active Inhibitor ◽

Significant Difference

AbstractPandemic SARS-CoV-2 causes a mild to severe respiratory disease called Coronavirus Disease 2019 (COVID-19). Control of SARS-CoV-2 spread will depend on vaccine-induced or naturally acquired protective herd immunity. Until then, antiviral strategies are needed to manage COVID-19, but approved antiviral treatments, such as remdesivir, can only be delivered intravenously. Enisamium (laboratory code FAV00A, trade name Amizon®) is an orally active inhibitor of influenza A and B viruses in cell culture and clinically approved in countries of the Commonwealth of Independent States. Here we show that enisamium can inhibit SARS-CoV-2 infections in NHBE and Caco-2 cells. In vitro, the previously identified enisamium metabolite VR17-04 directly inhibits the activity of the SARS-CoV-2 RNA polymerase. Docking and molecular dynamics simulations suggest that VR17-04 prevents GTP and UTP incorporation. To confirm enisamium’s antiviral properties, we conducted a double-blind, randomized, placebo-controlled trial in adult, hospitalized COVID-19 patients, which needed medical care either with or without supplementary oxygen. Patients received either enisamium (500 mg per dose) or placebo for 7 days. A pre-planned interim analysis showed in the subgroup of patients needing supplementary oxygen (n = 77) in the enisamium group a mean recovery time of 11.1 days, compared to 13.9 days for the placebo group (log-rank test; p=0.0259). No significant difference was found for all patients (n = 373) or those only needing medical care (n = 296). These results thus suggest that enisamium is an inhibitor of SARS-CoV-2 RNA synthesis and that enisamium treatment shortens the time to recovery for COVID-19 patients needing oxygen.Significance statementSARS-CoV-2 is the causative agent of COVID-19. Although vaccines are now becoming available to prevent SARS-CoV-2 spread, the development of antivirals remains necessary for treating current COVID-19 patients and combating future coronavirus outbreaks. Here, we report that enisamium, which can be administered orally, can prevent SARS-CoV-2 replication and that its metabolite VR17-04 can inhibit the SARS-CoV-2 RNA polymerase in vitro. Moreover, we find that COVID-19 patients requiring supplementary oxygen, recover more quickly than patients treated with a placebo. Enisamium may therefore be an accessible treatment for COVID-19 patients.

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Evaluating the effectiveness of a group-based resilience intervention versus psychoeducation for emergency responders in England: A randomised controlled trial

PLoS ONE ◽

10.1371/journal.pone.0241704 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0241704

Author(s):

Jennifer Wild ◽

Shama El-Salahi ◽

Michelle Degli Esposti ◽

Graham R. Thew

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Self Report ◽

Post Traumatic Stress ◽

Emergency Responders ◽

Significant Difference ◽

Randomised Controlled ◽

Resilience Intervention

Background Emergency responders are routinely exposed to traumatic critical incidents and other occupational stressors that place them at higher risk of mental ill health compared to the general population. There is some evidence to suggest that resilience training may improve emergency responders’ wellbeing and related health outcomes. The aim of this study was to evaluate the effectiveness of a tertiary service resilience intervention compared to psychoeducation for improving psychological outcomes among emergency workers. Methods We conducted a multicentre, parallel-group, randomised controlled trial. Minim software was used to randomly allocate police, ambulance, fire, and search and rescue services personnel, who were not suffering from depression or post-traumatic stress disorder, to Mind’s group intervention or to online psychoeducation on a 3:1 basis. The resilience intervention was group-based and included stress management and mindfulness tools for reducing stress. It was delivered by trained staff at nine centres across England in six sessions, one per week for six weeks. The comparison intervention was psychoeducation about stress and mental health delivered online, one module per week for six weeks. Primary outcomes were assessed by self-report and included wellbeing, resilience, self-efficacy, problem-solving, social capital, confidence in managing mental health, and number of days off work due to illness. Follow-up was conducted at three months. Blinding of participants, researchers and outcome assessment was not possible due to the type of interventions. Results A total of 430 participants (resilience intervention N = 317; psychoeducation N = 113) were randomised and included in intent-to-treat analyses. Linear Mixed-Effects Models did not show a significant difference between the interventions, at either the post-intervention or follow-up time points, on any outcome measure. Conclusions The limited success of this intervention is consistent with the wider literature. Future refinements to the intervention may benefit from targeting predictors of resilience and mental ill health. Trial registration ISRCTN registry, ISRCTN79407277.

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