Effectiveness of Early Tracheostomy compared with Late Tracheostomy Or Prolonged Orotracheal Intubation in Traumatic Brain Injury: Protocol of Systematic Review

Review question / Objective: What is the effectiveness of Early Tracheostomy compared with Late Tracheostomy Or Prolonged Orotracheal Intubation in Traumatic Brain Injury? Condition being studied: Traumatic Brain Injury (TBI) is every traumatic anatomical ou functional injury that affects brain, skull and/or vessels related to them. TBI is a public health problem that involves over 50 million people per year in Worldwide. Information sources: PUBLISHED DATABASES (Medline by PUBMED, Lilacs, Central-Cochrane, Scopus by Elsevier, Web Of Science e Embase by Elsevier) NON-PUBLISHED (Open Grey by Sigle; Clinical Trial Register at the International Clinical Trials Registry Platform) (Referencies of the selected studies).

Effects of two training programs on health variables in adults with chronic low back pain: a randomized clinical trial

Aim: To analyze the effects of two training programs on health variables in adults with low back pain (LBP). Methods: Thirty-eight adults were randomly divided into three groups: resistance training (RG); resistance training with core training (RCG) and control (CG). Results: There were reductions in body mass index (BMI) in RG and RCG, waist circumference in RG and RCG, pain in RG, RCG and CG, CK in RCG, stress in RG and RCG, functional deficiency in RG and RCG and increases in trunk flexor and extensor strength in the RG and RCG. Conclusion: Resistance training, with or without core training exercises, reduced the levels of LBP, functional disability, stress and CK, and increased the strength of trunk flexors and extensors. Trial registration: Brazilian Clinical Trials Registry: ReBEC (RBR-5khzxz)

Associations of COVID-19 lockdown restrictions with longer-term activity levels of working adults with type 2 diabetes (Preprint)

BACKGROUND Lockdown restrictions reduce COVID-19 community transmission; however, they may pose challenges for non-communicable disease management. A 112-day hard lockdown in Victoria, Australia (commencing March 23, 2020), which affected an intervention trial of reducing and breaking up sitting time in desk workers with type 2 diabetes who were using a provided consumer grade activity tracker (Fitbit). OBJECTIVE To compare continuously recorded activity levels preceding and during COVID-19 lockdown restrictions among working adults with type 2 diabetes participating in a sitting less and moving more intervention. METHODS Eleven participants (8/11 male; mean [SD] age 52.8 [5.0] years) in Melbourne, Australia had Fitbit activity tracked before (mean [SD]: 122.7 [47.9] days) and during (99.7 [62.5] days) city-wide COVID-19 lockdown restrictions. Regression models compared device (Fitbit Inspire HR)-derived activity (steps; METs [metabolic equivalents], mean time in sedentary, lightly, fairly, and very active minutes, and usual bout durations) during restrictions, to pre-restriction. Relative rates (RR) <1.00 indicated a decline in activity levels following restrictions. RESULTS Total wear days were 2447. There was a decrease in steps (-1,584 steps; RR: 0.91; 95%CI: 0.89, 0.93), METs (-83 METs; RR: 0.95; 95%CI: 0.94, 0.95), lightly active (RR: 0.96; 95%CI: 0.92, 0.99), fairly active (RR: 0.82; 95%CI: 0.79, 0.85), very active (RR: 0.92; 95%CI: 0.89, 0.95) intensity minutes, and increases in sedentary minutes (RR: 1.03; 95%CI: 1.01, 1.06). Only very active (+5.1mins) and sedentary (+4.3mins) bout durations changed significantly. CONCLUSIONS In adults with type 2 diabetes, COVID-19 lockdown restrictions were associated with decreases in overall activity levels and increases in very active and sedentary bout durations. A Fitbit monitor provided meaningful continuous long term data in this context. CLINICALTRIAL Australian New Zealand Clinical Trials Registry ANZCTRN12618001159246

Adolescent Perspectives on Participating in a Feasibility Trial Investigating Shoe Inserts for Patellofemoral Pain

Background Patellofemoral pain (PFP) affects one-quarter of adolescents, yet there are few evidence-informed recommendations to treat PFP in this population. HAPPi Kneecaps! is a randomised, controlled, participant- and assessor-blind, parallel-group feasibility trial of shoe inserts for adolescents with PFP. The aim of this qualitative study was to explore adolescents’ perspectives of participating in HAPPi Kneecaps!. Methods All 36 adolescents with PFP from the HAPPi Kneecaps! study were invited to participate in semi-structured interviews. We used a descriptive qualitative methodology underpinned by a relativist framework to investigate adolescents’ perspectives on participating in the trial. Inductive thematic analysis was used to examine patterns regarding how each adolescent experienced the HAPPi Kneecaps! study within their social, cultural, and historical contexts. Results 14 out of 36 HAPPi Kneecaps! participants provided consent and participated in interviews (12 females; mean [SD] age 14.9 [2.4] years). Overall, most adolescents responded positively when discussing their experience, such as improvements in their knee pain and satisfaction with how the study was run. Major themes emerging from the analysis and feedback were: (1) shoe inserts require little effort to use; (2) shoe inserts improve symptoms and function; (3) participation in the trial could be made easier; (4) warm weather matters; and (5) life happens. Conclusion Adolescents with PFP who participated in the HAPPi Kneecaps! study found that shoe inserts were easy to wear. Most adolescents experienced an improvement in their symptoms and enhanced participation in sport and exercise. Adolescents with PFP prefer an option for warmer climates (e.g. flip flops or sandals), access to online logbooks, and clinicians who are easily accessible. Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12619000957190. Date registered: 8/07/2019.

Soil-transmitted helminth infections and nutritional indices among Filipino schoolchildren

Background Soil-transmitted helminth (STH) infections are still prevalent among schoolchildren in the Philippines. We evaluated the risk factors associated with STH and the relationship between STH and nutritional indices among schoolchildren aged 9–10 years in Laguna province, the Philippines. Methods We used the baseline data from 40 schools enrolled in a randomised controlled trial of the Magic Glasses Philippines health education package. Data on demographic and socio-economic variables, and STH related knowledge, attitudes and practices, were obtained through a questionnaire. Stool samples were collected and assessed for STH egg presence using the Kato-Katz technique. Haemoglobin levels and height and weight of study participants were also determined. The generalized estimating equations approach was used to construct logistic regression models to assess STH-associated risk factors, and the association between any STH infection and anaemia, child stunting, wasting and being underweight. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000508471). Findings Among 1,689 schoolchildren, the prevalence of any STH was 23%. The prevalence of anaemia, stunting, being underweight and wasting was 13%, 20.2%, 19% and 9.5%, respectively. Age, socio-economic status, rural/urban classification of schools and knowledge of STH were significant risk factors for acquiring a STH infection. Moreover, infections with any STH were significantly associated with stunting (P = <0.001) and being underweight (P = <0.003), but not wasting (P = 0.375) or anaemia (P = 0.462) after controlling for confounding covariates. Conclusion The study findings emphasise the need for sustainable deworming in tandem with other measures such as the provision of health education, improvements in sanitation and hygiene, and nutritional programs in order to control STH infections and improve morbidity outcomes in schoolchildren. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12616000508471).

Influence of Vibrotactile Random Noise on the Smoothness of the Grasp Movement in Patients in Chemotherapy-Induced Peripheral Neuropathy

Background Patients with chemotherapy-induced peripheral neuropathy (CIPN) often suffer from sensorimotor dysfunction of the distal portion of the extremities (e.g., loss of somatosensory sensation, numbness/tingling, difficulty typing on a keyboard, or difficulty undoing or doing up a button). The present study aimed to reveal the effects of subthreshold vibrotactile random noise stimulation on sensorimotor dysfunction in CIPN patients without exacerbating symptoms. Methods Twenty-five patients with CIPN and 28 age-matched healthy adults participated in this study. To reveal the effects of subthreshold vibrotactile random noise stimulation on sensorimotor function, participants were asked to perform grasp movement tasks during random noise stimulation delivered to the volar and dorsal wrist. We set three intensity conditions of the vibrotactile random noise: 0%, 60%, and 120% of the sensory threshold (Noise 0%, Noise 60%, and Noise 120% conditions). In the grasp movement task, the distance between the thumb and index finger was recorded while the participant attempted to grasp a target object, and the smoothness of the grasp movement was quantified by calculating normalized jerk in each experimental condition. The experimental data were compared using two-way repeated-measures analyses of variance with two binary factors: experimental condition (Noise 0%, 60%, 120%) × group (Healthy controls, CIPN patients).Results The smoothness of the grasp movement was only improved in the Noise 60% condition without exacerbating numbness/tingling in CIPN patients and healthy controls. Conclusions The current study suggested that the development of treatment devices using stochastic resonance can improve sensorimotor function for CIPN patients.Trial registration UMIN Clinical Trials Registry（UMIN-CTR）No. UMIN000024776https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000024776#

Preoperative education in patients undergoing foot and ankle surgery: A scoping review protocol

Objective: We aim to identify and to describe all the available evidence addressing preoperative education on patients undergoing any foot and ankle surgery.Design: This is the protocol for a scoping review of the literature.Data sources: We will perform electronic searches on Pubmed/MEDLINE, EMBASE, CINAHL, LILACS, ERIC, Scopus, The Cochrane library, clinicaltrials.gov and the International Clinical Trials Registry Platform. We will broad this search by conducting a cross-citation search in Google Scholar of all included studies and by checking their references. Eligibility criteria and methods: We will include any study addressing preoperative education on patients undergoing a foot and ankle surgery, without regard to their design or language. Two independent authors will select the studies and extract the data. We will extract data concerning the characteristics of each study, their participants, and data about the preoperative education they evaluated.Ethics: No ethics committee approval is required.

The Pharmacokinetic Study of Progesterone and Allopregnanolone in Refractory Epilepsy : Phase II Study

Background: Progesterone belongs to a class of neurosteroids used for the reduction of seizure frequency in patients with refractory epilepsy. However, the pharmacokinetics of progesterone and its active derivative, allopregnanolone, have never been studied in these patients. Objectives: This study was aim to explore the pharmacokinetic parameters of progesterone 400 mg every 12 h, for 3 months, in patients with refractory epilepsy as an add-on therapy to control seizures. Phoenix® WinNonlin® was used to analyse the pharmacokinetic parameters. Results: Twelve patients were recruited. From a therapeutic drug monitoring, the serum progesterone and allopregnanolone levels after taking the first dose of progesterone were characterised by a time to maximum concentration (Tmax) median of 1 and 2.5 h, a maximum concentration (Cmax) median of 274.97 and 3.81 ng/mL, and a minimum concentration (Cmin) median of 56.93 and 1.06 ng/mL, respectively. The median values of the pharmacokinetic parameters of progesterone and allopregnanolone during the steady state were as follows: t1/2 of 2.4 and 2.0 h, Cmax of 964.35 and 8.92 ng/mL, and Cmin of 64.67 and 1.86 ng/mL, respectively. By examining the relationship between the progesterone or allopregnanolone concentrations with seizure-controlling ability, we could identify a responder patient group with 6- to 7-fold higher serum concentrations of progesterone and allopregnanolone than the non-responders. Conclusions: We could establish higher serum levels of both progesterone and allopregnanolone, which could consequently relate to lowering the seizure frequency in patients with refractory epilepsy. The suggested progesterone dose was 400 mg orally every 12 h against refractory epilepsy Trial registration: This study has been registered on the Thai Clinical Trials Registry (No. TCTR20200710005, 10 July 2020)

Assistive Robots for Patients with ALS: An Exploratory Study with an Early Stage Demonstrator (Preprint)

BACKGROUND Although robotic manipulators have great potential in promoting motor independence of people with motor impairments, only few systems are currently commercially available. In addition to technical, economic and normative barriers, a key challenge for their diffusion is the current lack of evidence regarding usefulness, acceptance and user-specific requirements. OBJECTIVE Against this background, a semi-autonomous robot system was developed in the R&D project ROBINA to support people with amyotrophic lateral sclerosis (ALS) in various everyday activities. METHODS The developed early stage demonstrator was evaluated in a task-based laboratory study with eleven ALS patients. Based on a mixed-methods design consisting of standardized questionnaires, observation protocols, and semi-structured interviews, participants were asked about usability, acceptance, and design requirements. RESULTS The majority of the participants considered the system provide relevant support within the test scenarios and perceived it as easy to use. Technical requirements consisted in precise object manipulation, reliable autonomous robot actions, and an intuitive GUI. In addition, the adaptability of the system to the abilities and disease-related limitations of the users, as well as a higher degree of intervention in the control and autonomous robot actions, was highlighted. Finally, the need for a holistic concept of robotic assistance in order to adequately address user-specific needs, was emphasized. CONCLUSIONS In summary, it can be stated that robotic manipulators can contribute to the compensation of motor impairments and increase both the autonomy and the psychological well-being of those affected. In this context, further opportunities to relieve the burden on the care network can be expected, especially regarding repetitive actions. CLINICALTRIAL The study is registered in the German Clinical Trials Registry (DRKS00016554).

Antidepressant efficacy of low-frequency repetitive transcranial magnetic stimulation in antidepressant-nonresponding bipolar depression: a single-blind randomized sham-controlled trial

Background To examine the antidepressant efficacy and response predictors of R-DLPFC-LF rTMS for antidepressant-nonresponding BD. Methods We conducted a single-blind randomized sham-controlled trial for 54 (28 sham, 26 active) patients with antidepressant-nonresponding BD (baseline MADRS ≥ 20). Patients received 15 daily sessions of active or sham neuronavigated rTMS (Figure-of-8 coil, five 1 Hz 60 s 110% RMT trains). Outcome measures included depressive response (≥ 50% MADRS reduction, CGI ≤ 2) and remission (MADRS < 7, CGI = 1) rates, treatment emergent hypo/mania (YMRS), depressive and anxiety symptoms (HAM-A). Results 48 patients (25 sham, 23 active) completed treatment, with 3 drop-outs each in active and sham groups. Active rTMS did not produce superior response or remission rates at endpoint or 6 or 12 weeks (ps > 0.05). There was no significant group * time interaction (ps > 0.05) in a multivariate ANOVA with MADRS, HAMA and YMRS as dependent variables. Exploratory analysis found MADRS improvement to be moderated by baseline anxiety (p = 0.02) and melancholia (p = 0.03) at week 3, and depressive onset at weeks 6 (p = 0.03) and 12 (p = 0.04). In subjects with below-mean anxiety (HAMA < 20.7, n = 24), MADRS improvement from active rTMS was superior to sham at week 3 (ITT, t = 2.49, p = 0.04, Cohen’s d = 1.05). No seizures were observed. Groups did not differ in treatment-emergent hypomania (p = 0.1). Limitations Larger sample size might be needed to power subgroup analyses. Moderation analyses were exploratory. Single-blind design. Unblinding before follow-up assessments due to ethical reasons. Conclusions 1-Hz 110% RMT (5 × 60 s trains) R-DLPFC-LF rTMS was not effective for antidepressant non-responding BD but may be further investigated at increased dosage and/or in BD patients with low anxiety. Trial registration CCRB Clinical Trials Registry, CUHK, CUHK_CCT00440. Registered 04 December 2014, https://www2.ccrb.cuhk.edu.hk/registry/public/279