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1.
Behav Neurosci ; 134(5): 369-383, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-33001679

RESUMO

This study investigated whether the application of high definition transcranial DC stimulation (HD-tDCS) to the dorsolateral prefrontal cortex reduces cue-induced food craving when combined with food-specific inhibitory control training. Using a within-subjects design, participants (N = 55) received both active and sham HD-tDCS across 2 sessions while completing a Go/No-Go task in which foods were either associated with response inhibition or response execution. Food craving was measured pre and post stimulation using a standardized questionnaire as well as desire to eat ratings for foods associated with both response inhibition and response execution in the training task. Results revealed no effect of HD-tDCS on reducing state food craving or desire to eat. Due to the COVID-19 pandemic, we were unable to achieve our maximum preplanned sample size or our minimum desired Bayesian evidence strength across all a priori hypotheses; however 6 of the 7 hypotheses converged with moderate or stronger evidence in favor of the null hypothesis over the alternative hypothesis. We discuss the importance of individual differences and provide recommendations for future studies with an emphasis on the importance of cognitive interventions. (PsycInfo Database Record (c) 2020 APA, all rights reserved).


Assuntos
Fissura/fisiologia , Preferências Alimentares/fisiologia , Córtex Pré-Frontal/fisiologia , Adulto , Teorema de Bayes , Estudos Cross-Over , Sinais (Psicologia) , Feminino , Alimentos , Humanos , Masculino , Inquéritos e Questionários , Estimulação Transcraniana por Corrente Contínua/métodos
2.
J Contemp Dent Pract ; 21(6): 604-608, 2020 Jun 01.
Artigo em Inglês | MEDLINE | ID: mdl-33025926

RESUMO

AIM: This study aims to evaluate and compare the efficacy of auto-control syringe (ACS) and insulin syringe (IS) for palatal local anesthesia administration in children. MATERIALS AND METHODS: The study was a double-blind, randomized, and crossover trial, comprising 80 children requiring palatal anesthesia bilaterally (total 160 injections). Palatal anesthesia on one side was delivered with ACS in one appointment and contralaterally with IS in the second appointment. One-week washout period was given between first and second appointments. Each child acted as his own control. Each injection technique subjective and objective pain scores were measured twice (during needle prick and during actual deposition of local anesthesia). Subjective and objective evaluation of pain was measured with Wong-Baker FACES pain rating scale (WB-FPS) and the face, leg, activity, cry, and consolability scale (FLACC), respectively. After concluding second appointment, child was asked about their preference between both ACS and IS. Statistical evaluation was performed using Chi-square test. RESULTS: Child reported less pain score for needle prick with IS as opposed to ACS (p value = 0.000416). There was no significant difference between dentist-reported pain scores between any group for both needle prick and local anesthesia administration. There is no significant difference between child reported pain score during administration of local anesthesia between two groups. Irrespective of pain scores, most of the children (96.5%) preferred IS. CONCLUSION: For palatal local anesthesia administration in children, both IS and auto-controlled syringe have similar efficacy. CLINICAL SIGNIFICANCE: Insulin syringe can serve as an economical alternative to the expensive auto-controlled syringe for palatal injections in children.


Assuntos
Anestesia Dentária , Anestésicos Locais , Insulinas , Seringas , Anestesia Dentária/métodos , Anestésicos Locais/administração & dosagem , Criança , Estudos Cross-Over , Humanos , Medição da Dor
4.
Pancreas ; 49(9): e82-e83, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33003092
5.
Medicine (Baltimore) ; 99(41): e22318, 2020 Oct 09.
Artigo em Inglês | MEDLINE | ID: mdl-33031270

RESUMO

INTRODUCTION: The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits. One group is that of nitric oxide increasing supplements, so-called "NO-boosters," which are claimed to improve the supply of oxygen and nutrients to the muscle by enhancing vasodilation.The aim of this study was to investigate 3 of these supplements in healthy male athletes for their muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS). METHODS: This placebo-controlled, double-blind, randomized cross-over trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Three commercial NO enhancing products including 300 mg of the specific green tea extract VASO6 and a combination of 8 g L-citrulline malate and 3 g L-arginine hydrochloride will be examined for their potential to increase muscular perfusion in 30-male athletes between 18 and 40 years and will be compared with a placebo. On each of the 3 appointments CEUS of the dominant biceps muscle will be performed at rest and after a standardized resistance training. Every athlete receives each of the 3 supplements once after a wash-out period of at least 1 week. Perfusion will be quantified via VueBox quantification software. The results of CEUS perfusion measurements will be compared intra- and interindividually and correlated with clinical parameters. DISCUSSION: The results of this study may help to establish CEUS as a suitable imaging modality for the evaluation of potentially vasodilatory drugs in the field of sports. Other supplements could also be evaluated in this way to verify the content of their advertising claims. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), ID: DRKS00016972, registered on 25.03.2019.


Assuntos
Arginina/administração & dosagem , Citrulina/administração & dosagem , Músculo Esquelético/irrigação sanguínea , Músculo Esquelético/diagnóstico por imagem , Chá , Ultrassonografia/métodos , Adolescente , Adulto , Meios de Contraste , Estudos Cross-Over , Suplementos Nutricionais , Método Duplo-Cego , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Vasodilatação
6.
Medicine (Baltimore) ; 99(39): e22411, 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32991471

RESUMO

BACKGROUND: Acute exercise leads to an immediate drop in blood pressure (BP), also called post-exercise hypotension (PEH). Exercise in hypoxia is related to additional vasodilation, potentially contributing to more profound PEH. Therefore, we investigated the impact of hypoxia versus normoxia on the magnitude of PEH. Second, we examined whether these changes in PEH relate to the BP-lowering effects of 12-week exercise training under hypoxia. METHODS: In this prospective study, 21 healthy individuals (age 22.2 ±â€Š3.0 years, 14 male) performed a 45-minute high-intensity running exercise on 2 different days in a random order, under hypoxia (fraction of inspired oxygen 14.5%) and normoxia (fraction of inspired oxygen 20.9%). BP was examined pre-exercise (t = 0) and at t = 15, t = 30, t = 45, and t = 60 minutes post-exercise. Afterward, subjects took part in a 12-week hypoxic running exercise training program. Resting BP was measured before and after the 12-week training program. RESULTS: Acute exercise induced a significant decrease in systolic BP (systolic blood pressure [SBP], P = .001), but not in diastolic BP (diastolic blood pressure [DBP], P = .113). No significant differences were observed in post-exercise BP between hypoxic and normoxic conditions (SBP, P = .324 and DBP, P = .204). Post-exercise changes in SBP, DBP, and mean arterial pressure significantly correlated to the 12-week exercise training-induced changes in SBP (r = 0.557, P = .001), DBP (r = 0.615, P < .001), and mean arterial pressure (r = 0.458, P = .011). CONCLUSION: Our findings show that hypoxia does not alter the magnitude of PEH in healthy individuals, whilst PEH relates to the BP-lowering effects of exercise. These data highlight the strong link between acute and chronic changes in BP.


Assuntos
Pressão Sanguínea , Treino Aeróbico , Hipóxia , Hipotensão Pós-Exercício/etiologia , Estudos Cross-Over , Feminino , Voluntários Saudáveis , Humanos , Masculino , Adulto Jovem
7.
Am J Vet Res ; 81(10): 775-782, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32969733

RESUMO

OBJECTIVE: To evaluate the thermal antinociceptive effects of hydromorphone hydrochloride after IM administration to orange-winged Amazon parrots (Amazona amazonica). ANIMALS: 8 healthy adult parrots (4 males and 4 females). PROCEDURES: In a randomized crossover study, each bird received hydromorphone (0.1, 1, and 2 mg/kg) and saline (0.9% NaCl) solution (1 mL/kg; control) IM, with a 7-day interval between treatments. Each bird was assigned an agitation-sedation score, and the thermal foot withdrawal threshold (TFWT) was measured at predetermined times before and after treatment administration. Adverse effects were also monitored. The TFWT, agitation-sedation score, and proportion of birds that developed adverse effects were compared among treatments over time. RESULTS: Compared with the mean TFWT for the control treatment, the mean TFWT was significantly increased at 0.5, 1.5, and 3 hours and 1.5, 3, and 6 hours after administration of the 1- and 2-mg/kg hydromorphone doses, respectively. Significant agitation was observed at 0.5, 1.5, and 3 hours after administration of the 1 - and 2-mg/kg hydromorphone doses. Other adverse effects observed after administration of the 1- and 2-mg/kg doses included miosis, ataxia, and nausea-like behavior (opening the beak and moving the tongue back and forth). CONCLUSIONS AND CLINICAL RELEVANCE: Although the 1- and 2-mg/kg hydromorphone doses appeared to have antinociceptive effects, they also caused agitation, signs of nausea, and ataxia. Further research is necessary to evaluate administration of lower doses of hydromorphone and other types of stimulation to better elucidate the analgesic and adverse effects of the drug in psittacine species.


Assuntos
Amazona , Analgésicos Opioides , Hidromorfona , Analgésicos , Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/farmacologia , Animais , Estudos Cross-Over , Feminino , Hidromorfona/efeitos adversos , Hidromorfona/farmacologia , Masculino
8.
J Oral Facial Pain Headache ; 34(3): 281-290, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32870957

RESUMO

AIMS: To investigate pain sensitivity in the masseter muscle and index finger in response to acute psychologic stress in healthy participants. METHODS: Fifteen healthy women (23.7 ± 2.3 years) participated in two randomized sessions: in the experimental stress session, the Paced Auditory Serial Addition Task (PASAT) was used to induce acute stress, and in the control session, a control task was performed. Salivary cortisol, perceived stress levels, electrical and pressure pain thresholds (PTs), and pain tolerance levels (PTLs) were measured at baseline and after each task. Mixed-model analysis was used to test for significant interaction effects between time and session. RESULTS: An interaction effect between time and session occurred for perceived stress levels (P < .001); perceived stress was significantly higher after the experimental task than after the control task (P < .01). No interaction effects occurred for salivary cortisol levels, electrical PTs, or pressure PTLs. Although significant interactions did occur for electrical PTL (P < .05) and pressure PT (P < .001), the simple effects test could not identify significant differences between sessions at any time point. CONCLUSION: The PASAT evoked significant levels of perceived stress; however, pain sensitivity to mechanical or electrical stimuli was not significantly altered in response to the stress task, and the salivary cortisol levels were not altered in response to the PASAT. These results must be interpreted with caution, and more studies with larger study samples are needed to increase the clinical relevant understanding of the pain mechanisms and psychologic stress.


Assuntos
Hidrocortisona , Limiar da Dor , Estudos Cross-Over , Feminino , Humanos , Músculo Masseter , Projetos Piloto , Saliva , Estresse Psicológico
9.
Int Heart J ; 61(5): 984-992, 2020 Sep 29.
Artigo em Inglês | MEDLINE | ID: mdl-32921665

RESUMO

Uric acid is generated with reactive oxygen species via xanthine oxidase (XO), and hyperuricemia, which is identified as the excess of uric acid in the blood, has been associated with vascular endothelial dysfunction. However, the effects of urate-lowering medicines on endothelial function have not been fully elucidated. Thus this study determined and compared the effects of benzbromarone (urate transporter 1 inhibitor) and febuxostat (XO inhibitor) on endothelial function.This randomized, cross-over, open-label study initially recruited 30 patients with hyperuricemia. They were divided into two groups, treated initially with benzbromarone or febuxostat for three months and then were switched for the next three months. Endothelial function was defined as reactive hyperemia indexes (RHI) determined using Endo-PAT 2000 before and at three and six months after medication using the two agents. Blood levels of asymmetric dimethylarginine (ADMA) and high-molecular-weight (HMW) adiponectin were also compared. We finally analyzed data from 24 patients whose endothelial function was assessed as described above.Our findings show that levels of uric acid significantly decreased, whereas those of HMW adiponectin and the RHI have significantly increased after treatment with benzbromarone. Meanwhile, in patients administered with febuxostat, uric acid levels tended to decrease and RHI significantly decreased. Neither of the two agents altered ADMA levels. The changes in RHI (P = 0.026) and HMW adiponectin levels (P = 0.001) were found to be significantly greater in patients treated with benzbromarone than febuxostat. Changes in the levels of HMW adiponectin and of uric acid were significantly correlated (r = -0.424, P = 0.039).Benzbromarone has increased adiponectin besides reducing uric acid levels, and thus, this might confer more benefits on endothelial function than febuxostat.


Assuntos
Benzobromarona/uso terapêutico , Endotélio Vascular/fisiopatologia , Febuxostat/uso terapêutico , Hiperemia/fisiopatologia , Hiperuricemia/tratamento farmacológico , Uricosúricos/uso terapêutico , Adiponectina/sangue , Idoso , Arginina/análogos & derivados , Arginina/sangue , Estudos Cross-Over , Feminino , Supressores da Gota/uso terapêutico , Humanos , Hiperuricemia/fisiopatologia , Masculino , Pessoa de Meia-Idade , Transportadores de Ânions Orgânicos/antagonistas & inibidores , Proteínas de Transporte de Cátions Orgânicos/antagonistas & inibidores , Resultado do Tratamento , Ácido Úrico/sangue , Xantina Oxidase/antagonistas & inibidores
11.
Am J Clin Oncol ; 43(9): 654-659, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32889836

RESUMO

OBJECTIVE: By using the Korean Pancreatic Cancer (K-PaC) registry, we compared the clinical outcomes of FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GNP) in patients with metastatic pancreatic cancer (MPC). METHODS: We constructed a web-based database of 3748 anonymized patients diagnosed with pancreatic ductal adenocarcinoma. MPC patients who received first-line FFX or GNP were enrolled. Overall survival (OS), progression-free survival, grade III to IV toxicity, and cross-over treatment were analyzed. RESULTS: A total of 413 patients (232 vs. 181, FFX vs. GNP; all data are presented in this sequence) were eligible. Median age was 63 years (60 vs. 69 y) with 43% (39% vs. 47%) comprising female individuals. The major metastatic sites were the liver (64%), peritoneum (25%), and distant lymph nodes (18%). The median OS was 11.5 versus 12.7 months (hazard ratio [HR]=0.87, 95% confidence interval [CI]: 0.68-1.12, P=0.286), and median progression-free survival was 7.5 versus 8.1 months (HR=0.92, 95% CI: 0.70-1.20, P=0.517), respectively. The frequency of grade III to IV febrile neutropenia was higher in the FFX group (18% vs. 11%, P=0.040), and that of peripheral neuropathy was higher in the GNP group (8% vs. 14%, P=0.046). The chance to receive second-line chemotherapy was higher in the GNP group (45% vs. 56%, P=0.036). In the cross-over treatment, the median OS of the FFX-GNP group (n=43) and the GNP-FFX group (n=47) was 16.8 versus 17.7 months (HR=0.79, 95% CI: 0.44-1.41, P=0.425). CONCLUSIONS: FFX and GNP showed similar efficacy and comparable toxicity in MPC patients. Although the GNP group had a higher chance to receive second-line chemotherapy, they did not have improved overall survival.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Ductal Pancreático/tratamento farmacológico , Neoplasias Hepáticas/secundário , Neoplasias Pancreáticas/tratamento farmacológico , Neoplasias Peritoneais/secundário , Idoso , Albuminas/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Carcinoma Ductal Pancreático/secundário , Estudos Cross-Over , Desoxicitidina/administração & dosagem , Desoxicitidina/análogos & derivados , Neutropenia Febril/induzido quimicamente , Feminino , Fluoruracila/efeitos adversos , Fluoruracila/uso terapêutico , Humanos , Irinotecano/efeitos adversos , Irinotecano/uso terapêutico , Leucovorina/efeitos adversos , Leucovorina/uso terapêutico , Metástase Linfática , Masculino , Pessoa de Meia-Idade , Oxaliplatina/efeitos adversos , Oxaliplatina/uso terapêutico , Paclitaxel/administração & dosagem , Neoplasias Pancreáticas/patologia , Doenças do Sistema Nervoso Periférico/induzido quimicamente , Intervalo Livre de Progressão , Sistema de Registros , República da Coreia , Taxa de Sobrevida , Resultado do Tratamento
12.
J Speech Lang Hear Res ; 63(10): 3293-3310, 2020 10 16.
Artigo em Inglês | MEDLINE | ID: mdl-32910735

RESUMO

Purpose Surface electromyography (sEMG) is often used for biofeedback during swallowing rehabilitation. However, commercially available sEMG electrodes are not optimized for the head and neck area, have rigid form, and are mostly available in large medical centers. We developed an ultrathin, soft, and flexible sEMG patch, specifically designed to conform to the submental anatomy and which will be ultimately incorporated into a telehealth system. To validate this first-generation sEMG patch, we compared its safety, efficiency, and signal quality in monitoring submental muscle activity with that of widely used conventional sEMG electrodes. Method A randomized crossover design was used to compare the experimental sEMG patch with conventional (snap-on) sEMG electrodes. Participants completed the same experimental protocol with both electrodes in counterbalanced order. Swallow trials included five trials of 5- and 10-ml water. Comparisons were made on (a) signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort. Noninferiority and equivalence tests were used to examine signal-related factors. Paired t tests and descriptive statistics were used to examine safety/preclinical factors. Results Forty healthy adults participated (24 women, M age = 67.5 years). Signal-related factors: SNR of the experimental patch was not inferior to the SNR of the conventional electrodes (p < .0056). Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes (p < .0001). Finally, normalized amplitude values were equivalent across swallows (5 ml: p < .025; 10 ml: p < .0012), and sEMG burst duration was also equivalent (5 ml: p < .0001; 10 ml: p < .0001). Safety/preclinical factors: The experimental patch resulted in fewer mild adverse effects. Participant satisfaction was higher with the experimental patch (p = .0476, d = 0.226). Conclusions Our new wearable sEMG patch is equivalent with widely used conventional sEMG electrodes in terms of technical performance. In addition, our patch is safe, and healthy older adults are satisfied with it. With lessons learned from the current COVID-19 pandemic, efforts to develop optimal swallowing telerehabilitation devices are more urgent than ever. Upon further validation, this new technology has the potential to improve rehabilitation and telerehabilitation efforts for patients with dysphagia. Supplemental Material https://doi.org/10.23641/asha.12915509.


Assuntos
Transtornos de Deglutição/reabilitação , Eletrodos , Eletromiografia/instrumentação , Telerreabilitação/instrumentação , Dispositivos Eletrônicos Vestíveis , Idoso , Betacoronavirus , Infecções por Coronavirus , Estudos Cross-Over , Deglutição/fisiologia , Eletromiografia/métodos , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral
13.
Cochrane Database Syst Rev ; 9: CD009402, 2020 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-32956536

RESUMO

BACKGROUND: Skeletal muscle cramps are common and often occur in association with pregnancy, advanced age, exercise or motor neuron disorders (such as amyotrophic lateral sclerosis). Typically, such cramps have no obvious underlying pathology, and so are termed idiopathic. Magnesium supplements are marketed for the prophylaxis of cramps but the efficacy of magnesium for this purpose remains unclear. This is an update of a Cochrane Review first published in 2012, and performed to identify and incorporate more recent studies. OBJECTIVES: To assess the effects of magnesium supplementation compared to no treatment, placebo control or other cramp therapies in people with skeletal muscle cramps.   SEARCH METHODS: On 9 September 2019, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, CINAHL Plus, AMED, and SPORTDiscus. We also searched WHO-ICTRP and ClinicalTrials.gov for registered trials that might be ongoing or unpublished, and ISI Web of Science for studies citing the studies included in this review. SELECTION CRITERIA: Randomized controlled trials (RCTs) of magnesium supplementation (in any form) to prevent skeletal muscle cramps in any patient group (i.e. all clinical presentations of cramp). We considered comparisons of magnesium with no treatment, placebo control, or other therapy. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion and extracted data. Two review authors assessed risk of bias. We attempted to contact all study authors when questions arose and obtained participant-level data for four of the included trials, one of which was unpublished. We collected all data on adverse effects from the included RCTs. MAIN RESULTS: We identified 11 trials (nine parallel-group, two cross-over) enrolling a total of 735 individuals, amongst whom 118 cross-over participants additionally served as their own controls. Five trials enrolled women with pregnancy-associated leg cramps (408 participants) and five trials enrolled people with idiopathic cramps (271 participants, with 118 additionally crossed over to control). Another study enrolled 29 people with liver cirrhosis, only some of whom suffered muscle cramps. All trials provided magnesium as an oral supplement, except for one trial which provided magnesium as a series of slow intravenous infusions. Nine trials compared magnesium to placebo, one trial compared magnesium to no treatment, calcium carbonate or vitamin B, and another trial compared magnesium to vitamin E or calcium. We judged the single trial in people with liver cirrhosis and all five trials in participants with pregnancy-associated leg cramps to be at high risk of bias. In contrast, we rated the risk of bias high in only one of five trials in participants with idiopathic rest cramps. For idiopathic cramps, largely in older adults (mean age 61.6 to 69.3 years) presumed to have nocturnal leg cramps (the commonest presentation), differences in measures of cramp frequency when comparing magnesium to placebo were small, not statistically significant, and showed minimal heterogeneity (I² = 0% to 12%). This includes the primary endpoint, percentage change from baseline in the number of cramps per week at four weeks (mean difference (MD) -9.59%, 95% confidence interval (CI) -23.14% to 3.97%; 3 studies, 177 participants; moderate-certainty evidence); and the difference in the number of cramps per week at four weeks (MD -0.18 cramps/week, 95% CI -0.84 to 0.49; 5 studies, 307 participants; moderate-certainty evidence). The percentage of individuals experiencing a 25% or better reduction in cramp rate from baseline was also no different (RR 1.04, 95% CI 0.84 to 1.29; 3 studies, 177 participants; high-certainty evidence). Similarly, no statistically significant difference was found at four weeks in measures of cramp intensity or cramp duration. This includes the number of participants rating their cramps as moderate or severe at four weeks (RR 1.33, 95% CI 0.81 to 2.21; 2 studies, 91 participants; moderate-certainty evidence); and the percentage of participants with the majority of cramp durations of one minute or more at four weeks (RR 1.83, 95% CI 0.74 to 4.53, 1 study, 46 participants; low-certainty evidence). We were unable to perform meta-analysis for trials of pregnancy-associated leg cramps. The single study comparing magnesium to no treatment failed to find statistically significant benefit on a three-point ordinal scale of overall treatment efficacy. Of the three trials comparing magnesium to placebo, one found no benefit on frequency or intensity measures, another found benefit for both, and a third reported inconsistent results for frequency that could not be reconciled. The single study in people with liver cirrhosis was small and had limited reporting of cramps, but found no difference in terms of cramp frequency or cramp intensity. Our analysis of adverse events pooled all studies, regardless of the setting in which cramps occurred. Major adverse events (occurring in 2 out of 72 magnesium recipients and 3 out of 68 placebo recipients), and withdrawals due to adverse events, were not significantly different from placebo. However, in the four studies for which it could be determined, more participants experienced minor adverse events in the magnesium group than in the placebo group (RR 1.51, 95% CI 0.98 to 2.33; 4 studies, 254 participants; low-certainty evidence). Overall, oral magnesium was associated with mostly gastrointestinal adverse events (e.g. diarrhoea), experienced by 11% (10% in control) to 37% (14% in control) of participants. AUTHORS' CONCLUSIONS: It is unlikely that magnesium supplementation provides clinically meaningful cramp prophylaxis to older adults experiencing skeletal muscle cramps. In contrast, for those experiencing pregnancy-associated rest cramps the literature is conflicting and further research in this population is needed. We found no RCTs evaluating magnesium for exercise-associated muscle cramps or disease-state-associated muscle cramps (for example amyotrophic lateral sclerosis/motor neuron disease) other than a single small (inconclusive) study in people with liver cirrhosis, only some of whom suffered cramps.


Assuntos
Magnésio/uso terapêutico , Cãibra Muscular/tratamento farmacológico , Músculo Esquelético , Complicações na Gravidez/tratamento farmacológico , Adulto , Fatores Etários , Idoso , Estudos Cross-Over , Feminino , Humanos , Magnésio/efeitos adversos , Masculino , Pessoa de Meia-Idade , Cãibra Muscular/etiologia , Placebos/uso terapêutico , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Ann Hematol ; 99(11): 2689-2698, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32974838

RESUMO

An open-label, crossover randomized study was performed to compare the pharmacokinetics (PK) of damoctocog alfa pegol and rurioctocog alfa pegol, two recombinant factor VIII (FVIII) products indicated in patients with hemophilia A, both conjugated to polyethylene glycol to reduce clearance and extend time in circulation. Adult patients (N = 18) with severe hemophilia A (FVIII < 1 IU/dL), previously treated with any FVIII product for ≥ 150 exposure days, were randomized to receive a single 50 IU/kg infusion of damoctocog alfa pegol followed by rurioctocog alfa pegol, or vice versa, with ≥ 7-day washout between doses. FVIII activity was measured using the one-stage clotting assay. PK parameters, including area under the curve from time 0 to the last data point (AUC0-tlast, primary parameter), dose-normalized AUC (AUCnorm), and time to threshold, were calculated based on 11 time points between 0.25 and 120 h post-dose and evaluated using a noncompartmental model. Due to differences in batch-specific vial content used for the study, actual administered median doses were 54.3 IU/kg for damoctocog alfa pegol and 61.4 IU/kg for rurioctocog alfa pegol. Based on actual dosing, a significantly higher geometric mean (coefficient of variation [%CV]) AUCnorm was observed for damoctocog alfa pegol (43.8 h kg/dL [44.0]) versus rurioctocog alfa pegol (36.0 h kg/dL [40.1, P < 0.001]). Based on population PK modeling, median time to reach 1 IU/dL was 16 h longer for damoctocog alfa pegol compared with rurioctocog alfa pegol. No adverse events or any immunogenicity signals were observed. Overall, damoctocog alfa pegol had a superior PK profile versus rurioctocog alfa pegol. Trial registration number: NCT04015492 ( ClinicalTrials.gov identifier). Date of registration: July 9, 2019.


Assuntos
Fator VIII , Hemofilia A , Adolescente , Adulto , Idoso , Estudos Cross-Over , Fator VIII/administração & dosagem , Fator VIII/farmacocinética , Meia-Vida , Hemofilia A/sangue , Hemofilia A/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Polietilenoglicóis , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/farmacocinética
15.
N Engl J Med ; 383(11): 1040-1049, 2020 09 10.
Artigo em Inglês | MEDLINE | ID: mdl-32905676

RESUMO

BACKGROUND: Darolutamide is a structurally distinct androgen-receptor inhibitor that is approved for the treatment of nonmetastatic, castration-resistant prostate cancer. In the planned primary analysis of a phase 3 trial, the median metastasis-free survival was significantly longer with darolutamide (40.4 months) than with placebo (18.4 months). The data for the analysis of overall survival were immature at the time of the primary analysis. METHODS: In this double-blind, placebo-controlled trial, we randomly assigned 1509 men, in a 2:1 ratio, to receive darolutamide (955 patients) or placebo (554 patients) while they continued to receive androgen-deprivation therapy. After the results of the primary end-point analysis were found to be positive, unblinding of the treatment assignments occurred, and patients in the placebo group were permitted to cross over to receive open-label darolutamide treatment. At the time of this prespecified final analysis, which had been planned to be performed after approximately 240 deaths had occurred, overall survival and all other secondary end points were evaluated. RESULTS: The median follow-up time was 29.0 months. At the time of unblinding of the data, all 170 patients who were still receiving placebo crossed over to receive darolutamide; 137 patients who had discontinued placebo before unblinding had occurred received at least one other life-prolonging therapy. Overall survival at 3 years was 83% (95% confidence interval [CI], 80 to 86) in the darolutamide group and 77% (95% CI, 72 to 81) in the placebo group. The risk of death was significantly lower, by 31%, in the darolutamide group than in the placebo group (hazard ratio for death, 0.69; 95% CI, 0.53 to 0.88; P = 0.003). Darolutamide was also associated with a significant benefit with respect to all other secondary end points, including the time to first symptomatic skeletal event and the time to first use of cytotoxic chemotherapy. The incidence of adverse events after the start of treatment was similar in the two groups; no new safety signals were observed. CONCLUSIONS: Among men with nonmetastatic, castration-resistant prostate cancer, the percentage of patients who were alive at 3 years was significantly higher among those who received darolutamide than among those who received placebo. The incidence of adverse events was similar in the two groups. (Funded by Bayer HealthCare and Orion Pharma; ARAMIS ClinicalTrials.gov number, NCT02200614.).


Assuntos
Antagonistas de Receptores de Andrógenos/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Pirazóis/uso terapêutico , Idoso , Antagonistas de Receptores de Andrógenos/efeitos adversos , Estudos Cross-Over , Método Duplo-Cego , Fadiga/induzido quimicamente , Fraturas Ósseas/induzido quimicamente , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Antígeno Prostático Específico/sangue , Neoplasias de Próstata Resistentes à Castração/mortalidade , Neoplasias de Próstata Resistentes à Castração/patologia , Pirazóis/efeitos adversos
16.
Nat Commun ; 11(1): 4643, 2020 09 16.
Artigo em Inglês | MEDLINE | ID: mdl-32938935

RESUMO

Time-restricted feeding (TRF) improves metabolism independent of dietary macronutrient composition or energy restriction. To elucidate mechanisms underpinning the effects of short-term TRF, we investigated skeletal muscle and serum metabolic and transcriptomic profiles from 11 men with overweight/obesity after TRF (8 h day-1) and extended feeding (EXF, 15 h day-1) in a randomised cross-over design (trial registration: ACTRN12617000165381). Here we show that muscle core clock gene expression was similar after both interventions. TRF increases the amplitude of oscillating muscle transcripts, but not muscle or serum metabolites. In muscle, TRF induces rhythmicity of several amino acid transporter genes and metabolites. In serum, lipids are the largest class of periodic metabolites, while the majority of phase-shifted metabolites are amino acid related. In conclusion, short-term TRF in overweight men affects the rhythmicity of serum and muscle metabolites and regulates the rhythmicity of genes controlling amino acid transport, without perturbing core clock gene expression.


Assuntos
Aminoácidos/sangue , Ritmo Circadiano/genética , Jejum , Lipídeos/sangue , Músculo Esquelético/metabolismo , Adulto , Relógios Circadianos/genética , Estudos Cross-Over , Expressão Gênica , Humanos , Metabolismo dos Lipídeos , Masculino , Músculo Esquelético/fisiologia , Sobrepeso/dietoterapia , Sobrepeso/metabolismo
17.
West J Emerg Med ; 21(5): 1080-1083, 2020 Aug 17.
Artigo em Inglês | MEDLINE | ID: mdl-32970558

RESUMO

INTRODUCTION: Barrier enclosures have been developed to reduce the risk of COVID-19 transmission to healthcare providers during intubation, but little is known about their impact on procedure performance. We sought to determine whether a barrier enclosure delays time to successful intubation by experienced airway operators. METHODS: We conducted a crossover simulation study at a tertiary academic hospital. Participants watched a four-minute video, practiced one simulated intubation with a barrier enclosure, and then completed one intubation with and one without the barrier enclosure (randomized to determine order). The primary outcome measure was time from placement of the video laryngoscope at the lips to first delivered ventilation. Secondary outcomes were periprocedural complications and participant responses to a post-study survey. RESULTS: Proceduralists (n = 50) from emergency medicine and anesthesiology had median intubation times of 23.6 seconds with practice barrier enclosure, 20.5 seconds with barrier enclosure, and 16.7 seconds with no barrier. Intubation with barrier enclosure averaged 4.5 seconds longer (95% confidence interval, 2.7-6.4, p < .001) than without, but was less than the predetermined clinical significance threshold of 10 seconds. Three complications occurred, all during the practice intubation. Barrier enclosure made intubation more challenging according to 48%, but 90% indicated they would consider using it in clinical practice. CONCLUSION: Experienced airway operators performed intubation using a barrier enclosure with minimal increased time to procedure completion in this uncomplicated airway model. Given potential to reduce droplet spread, use of a barrier enclosure may be an acceptable adjunct to endotracheal intubation for those familiar with its use.


Assuntos
Betacoronavirus , Competência Clínica/estatística & dados numéricos , Infecções por Coronavirus/terapia , Transmissão de Doença Infecciosa do Paciente para o Profissional/prevenção & controle , Intubação Intratraqueal/instrumentação , Pneumonia Viral/terapia , Adulto , Anestesiologia , Infecções por Coronavirus/transmissão , Estudos Cross-Over , Medicina de Emergência , Feminino , Humanos , Intubação Intratraqueal/métodos , Laringoscópios , Masculino , Manequins , Pandemias , Pneumonia Viral/transmissão , Fatores de Tempo
18.
PLoS One ; 15(8): e0238307, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32853281

RESUMO

OBJECTIVE: Auricular stimulation (AS) is a promising method in the treatment of situational anxiety. Expressive writing (EW) is an established psychological method, which reduces test anxiety and improves exam results. The aim of this crossover trial was to compare AS with EW, and with the no intervention (NI) condition, for treatment of exam anxiety. METHODS: Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized. AS was applied using indwelling fixed needles bilaterally at the areas innervated mostly by the auricular branch of the vagal nerve on the day before the exam. Anxiety level, measured using State-Trait-Anxiety Inventory (STAI) before and after the interventions and immediately before exam, was the primary outcome. Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA) were analyzed across 3 conditions. RESULTS: All 37 included participants completed the study. Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam. After EW and NI anxiety increased on the day of exam in comparison with baseline (P<0.01). Quality of sleep improved after AS in comparison with both control conditions (P<0.01). The activity of sAA decreased after EW and after AS (P<0.05) but not after NI condition. CONCLUSION: Auricular stimulation, but not expressive writing, reduced exam anxiety and improved quality of sleep in medical students. These changes might be due to reduced activity of the sympathetic nervous system.


Assuntos
Desempenho Acadêmico/psicologia , Transtornos de Ansiedade/prevenção & controle , Transtornos de Ansiedade/psicologia , Ansiedade/psicologia , Estudantes de Medicina/psicologia , Adolescente , Adulto , Ansiedade/metabolismo , Transtornos de Ansiedade/metabolismo , Pressão Sanguínea/fisiologia , Estudos Cross-Over , Feminino , Frequência Cardíaca/fisiologia , Humanos , Masculino , Redação , Adulto Jovem , alfa-Amilases/metabolismo
19.
PLoS One ; 15(8): e0235557, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32756564

RESUMO

AIM: Fibroblast growth factor 21 (FGF21) has recently been implicated in thirst in rodent models. The mechanisms for this are currently uncertain, and it is unclear whether hydration status can alter FGF21 concentrations, potentially providing an additional mechanism by which hypohydration induces thirst. The aim of this study is therefore to understand whether hydration status can alter circulating FGF21 in humans. METHODS: Using a heat tent and fluid restriction, we induced hypohydration (1.9% body mass loss) in 16 healthy participants (n = 8 men), and compared their glycaemic regulation to a rehydration protocol (heat tent and fluid replacement) in a randomised crossover design. RESULTS: After the hypohydration procedure, urine specific gravity, urine and serum osmolality, and plasma copeptin (as a marker for arginine vasopressin) increased as expected, with no change after the rehydration protocol. In the fasted state, the median paired difference in plasma FGF21 concentrations from the rehydrated to hypohydrated trial arm was -37 (interquartile range -125, 10) pg∙mL-1(P = 0.278), with average concentrations being 458 ± 462 pg∙mL-1 after hypohydration and 467 ± 438 pg∙mL-1 after rehydration; mean difference -9 ± 173 pg∙mL-1. CONCLUSION: To our knowledge, these are the first causal data in humans investigating hydration and FGF21, demonstrating that an acute bout of hypohydration does not impact fasted plasma FGF21 concentrations. These data may suggest that whilst previous research has found FGF21 administration can induce thirst and drinking behaviours, a physiological state implicated in increased thirst (hypohydration) does not appear to impact plasma FGF21 concentrations in humans.


Assuntos
Desidratação/sangue , Fatores de Crescimento de Fibroblastos/sangue , Adulto , Estudos Cross-Over , Desidratação/fisiopatologia , Desidratação/terapia , Comportamento de Ingestão de Líquido , Jejum/sangue , Feminino , Hidratação , Humanos , Masculino , Sede , Adulto Jovem
20.
PLoS One ; 15(8): e0237593, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32790734

RESUMO

BACKGROUND: Managing difficult pediatric airway is challenging. The MultiViewScope (MVS) Stylet Scope is reported to be useful in difficult pediatric airway. In this randomized crossover study, we compared the effectiveness of the MVS Stylet Scope to a standard direct laryngoscope with Miller #1 blade in simulated normal and difficult airways. METHODS: Fifteen expert anesthesiologists and Fifteen anesthesiology residents participated in the study. Participants were asked to perform intubation with the Airsim Baby manikin first, and then with the Airsim Pierre Robin manikin. Participants in each group used the intubation devices in a randomized order. The primary outcome was the time of successful intubation. The secondary outcomes were the force exerted on the incisors during intubation, Cormack-Lehane scale, the difficulty of intubation. RESULTS: There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved the force exerted on the incisors during intubation in the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved Cormack-Lehane scale, and the difficulty of intubation with difficult pediatric airway situation in both expert anesthesiologists and anesthesiology residents. CONCLUSIONS: Although less forces on the incisors and improved view of glottis were observed with the MVS Stylet Scope, MVS Stylet Scope did not shorten the time of intubation. The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study.


Assuntos
Manuseio das Vias Aéreas/métodos , Glote/anatomia & histologia , Intubação Intratraqueal/instrumentação , Laringoscópios/estatística & dados numéricos , Laringoscopia/métodos , Manequins , Sistema Respiratório/anatomia & histologia , Anestesiologia , Criança , Estudos Cross-Over , Humanos
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