RESUMEN
We implemented a crossover study design exposing 15 participants to two indoor air quality conditions in the Well Living Lab. The first condition, the Standard Control Condition, resembled the ventilation and air supply of a typical home in the USA with a manually operated stove hood. The second condition, Advanced Control, had an automated: (i) stove hood, (ii) two portable air cleaners (PAC), and (iii) bathroom exhaust. The PM2.5 sensors were placed in the kitchen, living room, bedroom, and bathroom. Once the sensor detected a PM2.5 level of 15 µg/m3 or higher, an air quality intervention (stove hood, PAC or bathroom exhaust) in that space was activated and turned off when the corresponding PM2.5 sensor had three consecutive readings below 6 µg/m3. Advanced Control in the overall apartment reduced PM2.5 concentration by 40% compared to the Standard Control. The PM2.5 concentration difference between Advanced and Standard Control was ~ 20% in the kitchen. This can be attributed to using the stove hood manually in 66.5% of cooking PM2.5 emission events for 323.6 h compared to 88 h stove hood used in automated mode alongside 61.9 h and 33.7 h of PAC use in living room and bedroom, respectively.
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Contaminación del Aire Interior , Culinaria , Vivienda , Material Particulado , Ventilación , Contaminación del Aire Interior/análisis , Contaminación del Aire Interior/prevención & control , Culinaria/métodos , Culinaria/instrumentación , Humanos , Material Particulado/análisis , Ventilación/métodos , Estudios Cruzados , Automatización , Monitoreo del Ambiente/métodos , Contaminantes Atmosféricos/análisisRESUMEN
Cool dialysate has variable impact on hemodynamic stability and dialysis adequacy. Hemodynamic stability and dialysis adequacy are crucial indicators for better life expectancy and cardiovascular mortality. This research aims to evaluate the impact of cool dialysate temperature (35.5°C) compared to standard dialysate temperature (37°C) on blood pressures, pulse rate, and dialysis adequacy (Urea reduction ratio and online Kt/V) in a cross over design. Material and Methods. Consenting ESRD patients on maintenance haemodialysis (HD) with minimum 3 months dialysis vintage and functioning permanent vascular access are included for the study. Each participant had two sessions of HD at 37°C followed by two sessions at 35.5° C on a Fresenius 4008S HD machine. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and Pulse rate are measured pre-HD, every hourly and post dialysis. Pre-HD Blood urea nitrogen (BUN) and post-HD BUN are measured, and Urea reduction rate was calculated for each HD session. Kt/V was calculated by ionic conductance by HD machine for each session. Results. 25 patients (5 females and 20 males) were enrolled. The mean age was 54 ± 9.58 years. Dialysis vintage was 21.48 ± 6.9 months for study participants 10 patients (40%) were diabetic nephropathy, 9 patients (36%) were presumed chronic glomerulonephritis, 2 patients (8%) were lupus nephritis and 4 patients (16%) were chronic interstitial nephritis. There was statistically no difference between pre-HD BUN (p = 0.330), post-HD BUN (p = 0.776), URR (p = 0.718) and Kt/V (p = 0.534) among the dialysis sessions done at 37°C and 35.5°C. SBP variability in the low temperature (35.5°C) group at 4th hour and post dialysis assumed statistical significance with p = 0.05 and p = 0.025 respectively. DBP variability in the low temperature (35.5°C) group at 3rd hour, 4th hour and post-dialysis demonstrated statistical significance with p = 0.027, p = 0.36 and p = 0.016 respectively. Pulse rate variability was more in the low temperature (35.5°C) group at 3rd hour and 4th hour which showed statistical significance with p = 0.037 and p = 0.05 respectively. Conclusion. Cool dialysate is non inferior to standard dialysate temperature in terms of dialysis adequacy and is associated with less variability in diastolic blood pressure, systolic blood pressure and more pulse rate variability thereby contributing to better hemodynamic stability.
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Estudios Cruzados , Hemodinámica , Fallo Renal Crónico , Diálisis Renal , Humanos , Femenino , Masculino , Diálisis Renal/métodos , Persona de Mediana Edad , Fallo Renal Crónico/terapia , Fallo Renal Crónico/fisiopatología , Presión Sanguínea , Soluciones para Diálisis/química , Soluciones para Hemodiálisis/química , Temperatura , Frecuencia Cardíaca , Anciano , Frío , Nitrógeno de la Urea SanguíneaRESUMEN
BACKGROUND: The main goal of the pediatric dentist is to address and reduce children's fear and anxiety during the dental treatment, especially when conventional behavior-guiding strategies fail. In such cases, the use of pharmacological agents becomes an essential factor to consider. OBJECTIVE: The objective of the study was to compare the efficacy, safety, and acceptability of intranasal ketamine (INK) with the combination of intranasal midazolam and dexmedetomidine (INMzD) in pediatric dental patients for the procedural sedation. PATIENTS AND METHODS: Forty-seven children aged 3-9 years who required dental procedures such as extractions, pulpectomy, and restorations were randomly distributed into two groups using the envelope drawing method. Group INK received 7 mg/kg INK, whereas Group INMzD received a combination of midazolam spray (0.3 mg/kg) and atomized dexmedetomidine (3 µg/kg). RESULTS: INK showed faster onset, faster recovery, and shorter discharge time than INMzD. Both groups had acceptable physiological parameters and no postoperative complications. INK was more accepted by the patients than INMzD. CONCLUSIONS: In terms of efficacy, safety, and acceptability, INK outperformed the combination of INMzD for the procedural sedation.
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Administración Intranasal , Sedación Consciente , Estudios Cruzados , Dexmedetomidina , Hipnóticos y Sedantes , Ketamina , Midazolam , Humanos , Dexmedetomidina/administración & dosificación , Midazolam/administración & dosificación , Niño , Preescolar , Ketamina/administración & dosificación , Hipnóticos y Sedantes/administración & dosificación , Masculino , Femenino , Sedación Consciente/métodos , Anestesia Dental/métodos , Atención Dental para Niños/métodos , Ansiedad al Tratamiento Odontológico/prevención & control , Extracción DentalRESUMEN
PURPOSE: Montelukast is used extensively in children and adolescents for allergic rhinitis and asthma. However, concerns have been raised regarding the increased risk of neuropsychiatric adverse events (NPAEs) associated with montelukast use. Therefore, our case-crossover study was conducted to observe whether there is an increased risk of NPAEs associated with montelukast use in children and adolescents. MATERIALS AND METHODS: A population-based case-crossover study using the customised Health Insurance Review and Assessment (HIRA) dataset was conducted. Paediatric patients aged between 0 and 19 years diagnosed with allergic rhinitis and/or asthma with a history of at least one montelukast prescription between 1 January 2018 and 31 December 2021 were included. Exposure to montelukast was assessed during 3-, 7-, 14-, 28- and 56-day hazard periods prior to each patient's NPAE. Stratified analyses according to age group, gender and season for the risk of NPAEs associated with montelukast use in the previous 7 days and 14 days were performed, respectively. Conditional logistic regression analysis was used to calculate adjusted ORs (aORs) with their corresponding 95% CIs, adjusting for concomitant medications. RESULTS: A total of 161 386 paediatric patients was identified. An increased risk of NPAEs associated with montelukast was found in all time window periods, including 3-day (aOR 1.28, 95% CI 1.24 to 1.32), 7-day (aOR 1.29, 95% CI 1.26 to 1.33), 14-day (aOR 1.34, 95% CI 1.31 to 1.37), 28-day (aOR 1.38, 95% CI 1.36 to 1.41) and 56-day (aOR 1.21, 95% CI 1.19 to 1.22) preceding hazard periods compared with use in the four control periods. CONCLUSION: Children and adolescents with allergic rhinitis and/or asthma should be prescribed montelukast with caution considering clinical benefits.
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Acetatos , Antiasmáticos , Asma , Estudios Cruzados , Ciclopropanos , Quinolinas , Sulfuros , Humanos , Niño , Adolescente , Masculino , Femenino , Preescolar , Acetatos/efectos adversos , Acetatos/uso terapéutico , Quinolinas/efectos adversos , Quinolinas/uso terapéutico , Sulfuros/efectos adversos , Asma/tratamiento farmacológico , Asma/epidemiología , Lactante , Antiasmáticos/efectos adversos , Antiasmáticos/administración & dosificación , Antiasmáticos/uso terapéutico , Rinitis Alérgica/epidemiología , Recién Nacido , Adulto JovenRESUMEN
We investigated the effect of repeated sessions of anodal transcranial direct current stimulation (a-tDCS) on subjective and objective measures of recovery, cognitive and sport-specific performance in professional soccer players following a soccer match simulation (SMS). Sixteen soccer players participated in this randomized, crossover, and sham-controlled study. They completed baseline assessments of well-being, total quality recovery (TQR), electromyographic activity (EMG) of the thigh muscles, countermovement jump (CMJ), and cognitive and Loughborough soccer passing test (LSPT) skills. Then, the participants engaged in an SMS routine (2 × 45 min, 15-min intervals). There was no significant difference in rating of perceived exertion (RPE) during the SMS in the anodal (17.25 ± 0.85) and sham (16.93 ± 0.92) conditions (p = 0.19). Following the SMS, the participants were randomized to receive three sessions of a-tDCS (2 mA, 20 min, +F3/-F4) targeting the left dorsolateral prefrontal cortex (DLPFC) or sham immediately after, 24 h, and 48 h after the SMS. Finally, the same outcome measures were evaluated 24 and 48 h following the SMS. A two-way repeated-measures ANOVA showed that a-tDCS stimulation improved passing skills (decreased time to perform the LSPT and number of errors; all ps < 0.01; d = 0.56-2.9) and increased the feeling of well-being (p = 0.02; d = 2.8), with no effect on TQR, cognitive performance, CMJ performance, and EMG. Therefore, the results of the present study indicate, for the first time, that repeated a-tDCS could be used as an adjunct method to accelerate soccer players' well-being and technical performance recovery, particularly after congested matches and/or training sessions. These findings may also be applicable to other team sports with characteristics similar to soccer (e.g., futsal, handball, basketball, etc.).
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Rendimiento Atlético , Fútbol , Estimulación Transcraneal de Corriente Directa , Humanos , Fútbol/fisiología , Estimulación Transcraneal de Corriente Directa/métodos , Rendimiento Atlético/fisiología , Masculino , Adulto Joven , Adulto , Estudios Cruzados , Electromiografía , Cognición/fisiología , AtletasRESUMEN
BACKGROUND: Breakthrough cancer pain (BTcP) has a negative impact on patients' quality of life, general activities, and is related to worse clinical outcomes. Fentanyl inhalant is a hand-held combination drug-device delivery system providing rapid, multi-dose (25µg/dose) administration of fentanyl via inhalation of a thermally generated aerosol. This multicenter, randomized, placebo-controlled, multiple-crossover, double-blind study evaluated the efficacy, safety, and tolerability of fentanyl inhalant in treating BTcP in opioid-tolerant patients. METHODS: The trial was conducted in opioid-tolerant cancer patients with 1 ~ 4 BTcP outbursts per day. Each patient was treated and observed for 6 episodes of BTcP (4 with fentanyl inhalant, 2 with placebo). During each episode of targeted BTcP, patients were allowed up to six inhalations, with an interval of at least 4 min between doses. Primary outcome was the time-weighted sum of PID (pain intensity difference) scores at 30 min (SPID30). RESULTS: A total of 335 BTcP episodes in 59 patients were treated. The mean SPID30 was -97.4 ± 48.43 for fentanyl inhalant-treated episodes, and -64.6 ± 40.25 for placebo-treated episodes (p < 0.001). Significant differences in PID for episodes treated with fentanyl inhalant versus placebo was seen as early as 4 min and maintained for up to 60 min. The percentage of episodes reported PI (pain intensity) scores ≤ 3, a ≥ 33% or ≥ 50% reduction in PI scores at 30 min, PR30 (pain relief scores at 30 min) and SPID60 favored fentanyl inhalant over placebo. Only 4.4% of BTcP episodes required rescue medication in fentanyl inhalant group. Most AEs were of mild or moderate severity and typical of opioid drugs. CONCLUSION: Treatment with fentanyl inhalant was shown to be a promising therapeutic option for BTcP, with significant pain relief starting very soon after dosing. Confirmation of effectiveness requires a larger phase III trial. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05531422 registered on 6 September 2022 after major amendment, NCT04713189 registered on 14 January 2021.
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Analgésicos Opioides , Dolor Irruptivo , Dolor en Cáncer , Fentanilo , Humanos , Fentanilo/uso terapéutico , Fentanilo/farmacología , Fentanilo/administración & dosificación , Método Doble Ciego , Masculino , Persona de Mediana Edad , Femenino , Analgésicos Opioides/uso terapéutico , Analgésicos Opioides/administración & dosificación , Dolor Irruptivo/tratamiento farmacológico , Dolor Irruptivo/etiología , Anciano , Dolor en Cáncer/tratamiento farmacológico , Adulto , Administración por Inhalación , Estudios Cruzados , Dimensión del Dolor/métodos , Resultado del Tratamiento , Anciano de 80 o más AñosRESUMEN
RATIONALE: Central neuropathic pain resulting from spinal cord injury is notoriously debilitating and difficult to treat with few currently available treatments. A novel molecule with intrathecal administration: Ziconotide has been approved for treatment of refractory neuropathic pain in general. It acts as a presynaptic calcium channel blocker. A pilot study has shown its potential in SCI neuropathic pain patients. OBJECTIVE: The aim of this study is to determine the long-term (6 months) efficacy of chronic intrathecal ziconotide for the treatment of neuropathic SCI pain. STUDY DESIGN: Multicenter, Randomized, Comparative, Placebo controlled, Double blind clinical trial, with a crossover of random alternated periods of 6 months (placebo or ITZ) for a total of 15 months including a total of 44 patients. STUDY POPULATION: ⢠Patients with SCI of various etiologies exhibiting neuropathic pain refractory to non-invasive treatments. ⢠> 18 years. INTERVENTION: Intrathecal administration of ziconotide via an implanted pump. STUDY OUTCOMES: Primary study outcome Difference in pain intensity for all patients between effective treatment and placebo periods. Secondary study outcomes 1. Continuous evaluation of pain intensity. 2. Percentage of patients with at least 30% of pain reduction. 3. Satisfaction level of the patient pain relief. 4. Declarations of serious adverse events. 5. Duration and intensity of spontaneous and provoked pain. 6. Quality of life. 7. Patient global impression of change. 8. Quantification of daily dosages of analgesic drug intake. 9. Long term memory and neurocognitive effects. 10. Assessment of the patient's physical and emotional distress. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study is in accordance with current treatment protocols for SCI neuropathic pain in France therefore it proposes a treatment that would currently be considered regular practice even though no RCT evidence is yet available. The study gives patients the advantage of directly testing versus placebo a treatment that otherwise entails significant constraints. A Data Safety Monitoring board (DSMB) will be created for continuous safety analysis. Furthermore, patients will be followed in specialized pain centers offering the possibility of continuing their treatment after the study period.
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Estudios Cruzados , Inyecciones Espinales , Neuralgia , Dimensión del Dolor , Traumatismos de la Médula Espinal , omega-Conotoxinas , Humanos , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/uso terapéutico , Método Doble Ciego , Neuralgia/tratamiento farmacológico , Neuralgia/etiología , Neuralgia/diagnóstico , omega-Conotoxinas/administración & dosificación , omega-Conotoxinas/efectos adversos , Satisfacción del Paciente , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Traumatismos de la Médula Espinal/complicaciones , Factores de Tiempo , Resultado del Tratamiento , Estudios Multicéntricos como AsuntoRESUMEN
The use of skin barrier-enhancing topical medication is a favorable approach for the treatment of occupational hand dermatitis (OHD). Cocos nucifera or coconut oil is one of the best sources of lipid enriched with laurate acid, and glycerin is a well-known humectant that improves skin hydration. This study is aimed is to evaluate the effectiveness of C. nucifera and glycerin for secondary prevention of OHD among batik (Indonesian traditional fabric) workers. In a randomized, double-blind, crossover trial, the effect of glycerine-C. nucifera cream versus glycerin-only was considered with multiple afterwork applications of moisturizer over a 2-week period on batik workers with OHD. Assessment of trans-epidermal water loss (TEWL), skin capacitance, and a clinical assessment using the Hand Eczema Severity Index (HECSI) were carried out at day 0 and 14. The results show thirty-two batik dyeing and/or rinsing workers were enrolled in the study with mild to moderate OHD. Clinical improvement was demonstrated by 20% decrease in HECSI and TEWL, and 20% increase in skin capacitance. Both moisturizers were equally effective for the secondary prevention of OHD. As a conclusion, glycerine-C. nucifera and glycerin-only cream are equally effective for secondary prevention for OHD among batik worker to reduce the prevalence of hand dermatitis.
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Cocos , Estudios Cruzados , Emolientes , Glicerol , Humanos , Adulto , Masculino , Método Doble Ciego , Femenino , Cocos/química , Emolientes/administración & dosificación , Emolientes/uso terapéutico , Persona de Mediana Edad , Dermatitis Profesional/prevención & control , Dermatitis Profesional/etiología , Dermatosis de la Mano/prevención & control , Dermatosis de la Mano/tratamiento farmacológico , Crema para la Piel/administración & dosificación , Crema para la Piel/uso terapéutico , Prevención Secundaria/métodosRESUMEN
BACKGROUND: Higher cruciferous vegetable intake is associated with lower cardiovascular disease risk in observational studies. The pathways involved remain uncertain. We aimed to determine whether cruciferous vegetable intake (active) lowers 24-h brachial systolic blood pressure (SBP; primary outcome) compared to root and squash vegetables (control) in Australian adults with mildly elevated BP (SBP 120-160 mmHg inclusive). METHODS: In this randomized, controlled, crossover trial, participants completed two 2-week dietary interventions separated by a 2-week washout. Cruciferous vegetables were compared to root and squash vegetables (~ 300 g/day) consumed with lunch and dinner meals. Participants were blinded to which interventions were the active and control. Adherence was assessed using food diaries and biomarkers (S-methyl cysteine sulfoxide (SMCSO, active) and carotenoids (control)). Twenty-four-hour brachial ambulatory SBP and secondary outcomes were assessed pre- and post each intervention. Differences were tested using linear mixed effects regression. RESULTS: Eighteen participants were recruited (median (IQR) age: 68 (66-70); female: n = 16/18; mean ± SD clinic SBP: 135.9 ± 10.0 mmHg). For both interventions, 72% participants had 100% adherence (IQR: 96.4-100%). SMCSO and carotenoids were significantly different between interventions (mean difference active vs. control SMCSO: 22.93 mg/mL, 95%CI 15.62, 30.23, P < 0.0001; carotenoids: - 0.974 mg/mL, 95%CI - 1.525, - 0.423, P = 0.001). Twenty-four-hour brachial SBP was significantly reduced following the active vs. control (mean difference - 2.5 mmHg, 95%CI - 4.2, - 0.9, P = 0.002; active pre: 126.8 ± 12.6 mmHg, post: 124.4 ± 11.8 mmHg; control pre: 125.5 ± 12.1 mmHg, post: 124.8 ± 13.1 mmHg, n = 17), driven by daytime SBP (mean difference - 3.6 mmHg, 95%CI - 5.4, - 1.7, P < 0.001). Serum triglycerides were significantly lower following the active vs. control (mean difference - 0.2 mmol/L, 95%CI - 0.4, - 0.0, P = 0.047). CONCLUSIONS: Increased intake of cruciferous vegetables resulted in reduced SBP compared to root and squash vegetables. Future research is needed to determine whether targeted recommendations for increasing cruciferous vegetable intake benefits population health. TRIAL REGISTRATION: Clinical trial registry ACTRN12619001294145. https://www.anzctr.org.au.
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Presión Sanguínea , Estudios Cruzados , Verduras , Humanos , Femenino , Masculino , Presión Sanguínea/fisiología , Presión Sanguínea/efectos de los fármacos , Anciano , Australia , Persona de Mediana Edad , Hipertensión/dietoterapia , Hipertensión/fisiopatologíaRESUMEN
This study investigated whether the electric field magnitude (E-field) delivered to the left dorsolateral prefrontal cortex (L-DLPFC) changes resting-state brain activity and the L-DLPFC resting-state functional connectivity (rsFC), given the variability in tDCS response and lack of understanding of how rsFC changes. Twenty-one healthy participants received either 2 mA anodal or sham tDCS targeting the L-DLPFC for 10 min. Brain imaging was conducted before and after stimulation. The fractional amplitude of low-frequency fluctuation (fALFF), reflecting resting brain activity, and the L-DLPFC rsFC were analyzed to investigate the main effect of tDCS, main effect of time, and interaction effects. The E-field was estimated by modeling tDCS-induced individual electric fields and correlated with fALFF and L-DLPFC rsFC. Anodal tDCS increased fALFF in the left rostral middle frontal area and decreased fALFF in the midline frontal area (FWE p < 0.050), whereas sham induced no changes. Overall rsFC decreased after sham (positive and negative connectivity, p = 0.001 and 0.020, respectively), with modest and nonsignificant changes after anodal tDCS (p = 0.063 and 0.069, respectively). No significant differences in local rsFC were observed among the conditions. Correlations were observed between the E-field and rsFC changes in the L-DLPFC (r = 0.385, p = 0.115), left inferior parietal area (r = 0.495, p = 0.037), and right lateral visual area (r = 0.683, p = 0.002). Single-session tDCS induced resting brain activity changes and may help maintain overall rsFC. The E-field in the L-DLPFC is associated with rsFC changes in both proximal and distally connected brain regions to the L-DLPFC.
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Estudios Cruzados , Corteza Prefontal Dorsolateral , Imagen por Resonancia Magnética , Estimulación Transcraneal de Corriente Directa , Humanos , Estimulación Transcraneal de Corriente Directa/métodos , Masculino , Femenino , Adulto , Adulto Joven , Corteza Prefontal Dorsolateral/fisiología , Vías Nerviosas/fisiología , Corteza Prefrontal/fisiología , Corteza Prefrontal/diagnóstico por imagen , Mapeo EncefálicoRESUMEN
OBJECTIVE: Unintentional injuries constitute a significant global public health issue with significant social and economic costs. Previous evidence suggests ambient temperatures are associated with unintentional injury occurrences. However, the impacts of ambient temperature on unintentional injury economic burden have received little research attention. The objective of the study was to examine the association between ambient temperature and economic burden of unintentional injury. DESIGN: Time-stratified case-crossover study. SETTING: This study was performed at Tianjin Hospital, the largest trauma centre in Tianjin, by applying a hospital-based time-stratified case-crossover study. PARTICIPANTS: The 12 241 patients admitted with unintentional injuries and meteorological data were collected in Tianjin, China in 2021. PRIMARY AND SECONDARY OUTCOME: The association between ambient temperature and unintentional injury hospitalisation was evaluated with a distributed lag non-linear model, further temperature-attributable economic burden of unintentional injuries was quantified, and adjusted for demographic characteristics, injury mechanism and injury location of injury. RESULTS: The temperatures below 11.5°C were significantly associated with the increased risk of unintentional injury hospitalisation in Tianjin, in 2021. The effect was maximised on the current day. The relatively low temperature was responsible for 25.44% (95% CI 13.74, 33.09) of unintentional injury patients, and was associated with the number of unintentional injury patients (3114, 95% CI 1608, 4036). The relatively low temperature was associated with the excess economic burden for unintentional injury (¥197.52 million, 95% CI 102.00, 256.00; about 27.10 million dollars), accounting for 26.49% of the total economic burden. The cold temperatures generally had greater impacts on males (¥136.46 million, 95% CI 83.28, 172.42; about 18.67 million dollars) and the elderly (¥74.35 million, 95% CI 14.87, 102.14; about 10.24 million dollars). CONCLUSION: The temperature was associated with approximately 3000 unintentional injury patients and ¥200 million (27 million dollars), accounting for 26% of the total economic burden in Tianjin, 2021.
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Lesiones Accidentales , Estudios Cruzados , Hospitalización , Heridas y Lesiones , Humanos , China/epidemiología , Masculino , Femenino , Persona de Mediana Edad , Adulto , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Anciano , Heridas y Lesiones/economía , Heridas y Lesiones/epidemiología , Lesiones Accidentales/epidemiología , Lesiones Accidentales/economía , Adolescente , Adulto Joven , Niño , Lactante , Preescolar , Temperatura , Costo de EnfermedadRESUMEN
BACKGROUND: Although natural rubber latex remains dominant as the primary manufacturing material for male condoms synthetic materials first introduced in the early 1990s address many of the limitations of latex including the risk of allergies. Polyurethane elastomers allow condoms to be made significantly thinner to provide greater sensitivity and encourage greater use of condoms for contraception and STI prophylaxis. The primary objective of this Study was to evaluate the breakage, slippage and acceptability of two ultra-thin polyurethane condoms against a thin control latex male condom, designated latex C, in a randomized, cross over, masked, non-inferiority study. The condom designated Polyurethane A was designed for markets where 52/53 mm wide latex condoms are preferred whereas the condom designated Polyurethane B was designed for markets where the smaller 49 mm wide latex condom is preferred. METHODS: The Study was designed to meet the requirements specified in ISO 29943-1: 2017 and FDA guidelines for clinical studies on synthetic condoms. It was conducted by two Essential Access Health centres, one in Northern California and the other in Southern California. Sexually active heterosexual couples (300) aged between 18 and 45 years were recruited to use three sets of five condoms in a block randomized order, recording breakage, slippage and acceptability after each use. A total of 252 couples contributed 2405 evaluable condom uses per protocol for the Condom A versus Latex C comparison (1193 Polyurethane A plus 1212 Latex C), and 247 couples provided 2335 evaluable condom uses per protocol for the Condom B versus Latex C comparison (1142 Polyurethane B plus 1193 Latex C). Only condoms used for vaginal intercourse were included in the analysis. FINDINGS: Although the total failure rates (breakage and slippage) for the polyurethane condoms were higher than for the control Latex C condom, all condoms performed extremely well with low failure rates compared to similar condom studies. Condom Polyurethane A met the noninferiority requirements specified in ISO 23409:2011 relative to Latex C, the control NR latex condom, in the full Study population. While condom Polyurethane B did not meet the noninferiority requirement for the full Study population, it did meet the noninferiority requirement when analysis was restricted to the intended population (men with penis lengths ≤ 170 mm). Trial registration The Study is registered with ClinicalTrials.gov, NCT04622306, Protocol Reference SAGCS 2, initial release date 11/02/2020.
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Condones , Falla de Equipo , Látex , Poliuretanos , Humanos , Condones/estadística & datos numéricos , Masculino , Adulto , Adulto Joven , Estudios Cruzados , Adolescente , Persona de Mediana Edad , FemeninoRESUMEN
The newly developed portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS) automatically switches between 3 sensitivities according to the negative pressure gradient of inhalation and supplies oxygen only during inhalation. The aim of this study was to verify the effectiveness and safety of auto-demand devices compared with a continuous flow oxygen concentrator, during sleep, in a randomized crossover noninferiority trial. We alternatively used an auto-DODS or a continuous-flow oxygen concentrator, all night on separate days for HOT (Home Oxygen Therapy) patients with nocturnal hypoxemic symptoms. The primary endpoints were the mean value of oxygen saturation (SpO2) over the total sleep time. The secondary endpoints included the efficacy endpoints and the safety endpoints. Regarding the primary endpoint, the difference in SpO2 between the auto-DODS and continuous flow was 0.835%. Since the upper limit of this difference did not exceed 2.8, which was set as the noninferiority margin, it was shown that the auto-DODS did not reduce SpO2 by at least 2.8% on average compared to continuous flow. No equipment failure or exacerbation of disease was observed, confirming the safety of the auto-DODS during the night.
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Estudios Cruzados , Hipoxia , Terapia por Inhalación de Oxígeno , Oxígeno , Humanos , Hipoxia/terapia , Masculino , Femenino , Terapia por Inhalación de Oxígeno/métodos , Terapia por Inhalación de Oxígeno/instrumentación , Persona de Mediana Edad , Oxígeno/metabolismo , Oxígeno/administración & dosificación , Anciano , Saturación de Oxígeno , AdultoRESUMEN
BACKGROUND: Risk perception varies greatly among individuals, affecting their behavior and decision-making in risky situations. The COVID-19 pandemic affected worldwide, but the role of risk perception related to COVID-19 in ethnic minorities in Mexico is unclear. This study quantifies the impact of COVID-related risk perception (susceptibility and severity) and perceived fear on the utilization of antenatal care services among indigenous women in San Cristobal de las Casas, Chiapas, Mexico. METHODS: We conducted a retrospective crossover study between June and December 2021, interviewing 98 women from San Cristóbal de las Casas, Chiapas. In a crossover design, each subject acts as their own control, so we required the participants to have a previous pregnancy experience. A logistic model was used to calculate the odds ratio for the outcome of having an adequate number of antenatal care visits. The analysis considered the period (during or before the pandemic) as well as perceived severity and susceptibility levels as independent variables. RESULTS: COVID-19 reduced antenatal care utilization by 50%. During the pandemic, the adjusted odds ratio for attending health antenatal care services was 0.83 (95% CI: 4.8, 14.5) compared to pre pandemics. Adjusted for fear of contagion, the mother's perception of severity was associated with an increased likelihood of an insufficient number of antenatal visits. OR = 0.25 (95% CI: 0.10, 0.65). CONCLUSION: The risk perception for COVID-19 decreased the likelihood of receiving an adequate number of antenatal care visits.
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COVID-19 , Aceptación de la Atención de Salud , Atención Prenatal , SARS-CoV-2 , Humanos , Femenino , COVID-19/psicología , COVID-19/epidemiología , Atención Prenatal/estadística & datos numéricos , Atención Prenatal/psicología , Embarazo , Adulto , Aceptación de la Atención de Salud/estadística & datos numéricos , Aceptación de la Atención de Salud/etnología , Aceptación de la Atención de Salud/psicología , México/etnología , Estudios Retrospectivos , Pueblos Indígenas/psicología , Pueblos Indígenas/estadística & datos numéricos , Estudios Cruzados , Adulto Joven , Percepción , Miedo/psicología , Medición de RiesgoRESUMEN
BACKGROUND: Individuals with non-celiac gluten/wheat sensitivity (NCGWS) experience improvement in gastrointestinal symptoms following a gluten-free diet. Although previous results have indicated that fructo-oligosaccharides (FOS), a type of short-chain fructans, were more likely to induce symptoms than gluten in self-reported NCGWS patients, the underlying mechanisms are unresolved. METHODS: Our main objective was therefore to investigate whether FOS-fructans and gluten affect the composition and diversity of the faecal microbiota (16S rRNA gene sequencing), faecal metabolites of microbial fermentation (short-chain fatty acids [SCFA]; gas chromatography with flame ionization detector), and a faecal biomarker of gut inflammation (neutrophil gelatinase-associated lipocalin, also known as lipocalin 2, NGAL/LCN2; ELISA). In the randomised double-blind placebo-controlled crossover study, 59 participants with self-reported NCGWS underwent three different 7-day diet challenges with gluten (5.7 g/day), FOS-fructans (2.1 g/day), and placebo separately (three periods, six challenge sequences). RESULTS: The relative abundances of certain bacterial taxa were affected differently by the diet challenges. After the FOS-fructan challenge, Fusicatenibacter increased, while Eubacterium (E.) coprostanoligenes group, Anaerotruncus, and unknown Ruminococcaceae genera decreased. The gluten challenge was primarily characterized by increased abundance of Eubacterium xylanophilum group. However, no differences were found for bacterial diversity (α-diversity), overall bacterial community structure (ß-diversity), faecal metabolites (SCFA), or NGAL/LCN2. Furthermore, gastrointestinal symptoms in response to FOS-fructans were generally not linked to substantial shifts in the gut bacterial community. However, the reduction in E. coprostanoligenes group following the FOS-fructan challenge was associated with increased gastrointestinal pain. Finally, correlation analysis revealed that changes in gastrointestinal symptoms following the FOS-fructan and gluten challenges were linked to varying bacterial abundances at baseline. CONCLUSIONS: In conclusion, while FOS-fructans induced more gastrointestinal symptoms than gluten in the NCGWS patients, we did not find that substantial shifts in the composition nor function of the faecal microbiota could explain these differences in the current study. However, our results indicate that individual variations in baseline bacterial composition/function may influence the gastrointestinal symptom response to both FOS-fructans and gluten. Additionally, the change in E. coprostanoligenes group, which was associated with increased symptoms, implies that attention should be given to these bacteria in future trials investigating the impact of dietary treatments on gastrointestinal symptoms. TRIAL REGISTRATION: Clinicaltrials.gov as NCT02464150.
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Estudios Cruzados , Heces , Fructanos , Microbioma Gastrointestinal , Glútenes , Humanos , Masculino , Femenino , Microbioma Gastrointestinal/efectos de los fármacos , Microbioma Gastrointestinal/fisiología , Glútenes/efectos adversos , Glútenes/administración & dosificación , Adulto , Heces/microbiología , Heces/química , Persona de Mediana Edad , Método Doble Ciego , Hipersensibilidad al Trigo/dietoterapia , Oligosacáridos/administración & dosificación , Adulto JovenRESUMEN
The study aimed to investigate the effects of acute ingestion of saffron (SAF) on physiological (i.e., heart rate and blood lactate) and perceptual (i.e., ratings of perceived exertion [RPE] and feeling scale) measures in response to a repeated-sprint ability test (RSS) in healthy young males (N = 22; mean ± SD: age, 21.7 ± 1.24 yrs.). All participants completed two experimental trials with a one-week washout period using a double-blind, placebo-controlled, crossover design. In each session, the participants were randomly chosen to receive either a capsule of saffron (300 mg) (SAF session) or a capsule of lactose (PLB session) two hours before performing the RSS.No significant differences (p > 0.05) were found for heart rate, RPE, and feeling scale between the SAF or PLB sessions at pre- and post-RSS. There were no significant changes (p > 0.05) in peak time, total time, fatigue index, and blood lactate in either the SAF or PLB sessions. Acute SAF ingestion did not significantly improve RSS performance nor physiological and perceptual measures in active young males. Future trials should address the topic by using shortened/prolonged higher doses of SAF on biological, physical, physiological, and perceptual responses to acute and chronic exercise.
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Crocus , Estudios Cruzados , Frecuencia Cardíaca , Ácido Láctico , Humanos , Masculino , Adulto Joven , Frecuencia Cardíaca/efectos de los fármacos , Frecuencia Cardíaca/fisiología , Ácido Láctico/sangre , Método Doble Ciego , Carrera/fisiología , Adulto , Esfuerzo Físico/fisiología , Esfuerzo Físico/efectos de los fármacos , Rendimiento Atlético/fisiologíaRESUMEN
Foam rolling have gained popularity among elite athletes, but the effect of the speed parameter of foam rolling has not yet been determined. Our objective was to investigate the impact of different application speeds of foam roller on the mechanical properties of the quadriceps femoris muscle. Eighteen male professional basketball athletes (age 23 ± 4 years, body mass index 24.43 ± 1.59 kg/m2) participated in this study. We used a crossover design to randomize the order of the treatment speeds (30 beats per minute-FAST, 15 beats per minute-SLOW, and a self-determined speed-SELF) with a one-week washout period between each session. We measured dominant quadriceps femoris muscle tone, elasticity, and stiffness using the Myoton device before and after the interventions. We found that the average rate for SELF was 33±10 beats per minute, making SELF the fastest. All application speeds showed similar results in pre-intervention measurements of the mechanical properties of the tissues (P > 0.05). However, post hoc analysis revealed that a decrease was evident in SLOW compared to SELF in muscle tone in post-intervention measurements (P = 0.037). Also, we noted that comparison of pre- and post-intervention on FAST and SLOW showed a significant reduction in muscle tone (P = 0.002, P = 0.008). Slower foam rolling prior to training or competition may lead to a delay in the reaction time due to the reduction in tonus, that can increase the injury risks. Alternatively, the significant reduction in tonus may be useful in regulating the increased tonus after training and competition.
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Baloncesto , Estudios Cruzados , Músculo Cuádriceps , Humanos , Masculino , Músculo Cuádriceps/fisiología , Adulto Joven , Baloncesto/fisiología , Fenómenos Biomecánicos , Adulto , Elasticidad , Tono Muscular/fisiologíaRESUMEN
Sensing of noxious heat has been reported to be mediated by TRPV1, TRPA1, TRPM3, and ANO1 in mice, and this is redundant so that the loss of one receptor is at least partially compensated for by others. We have established an infusion-based human heat pain model. Heat-induced pain probed with antagonists for the four receptors did not match the redundancy found in mice. In healthy participants, only TRPV1 contributes to the detection of noxious heat; none of the other three receptors are involved. TRPV1 inhibition reduced the pain at all noxious temperatures, which can also be seen as an increase in the temperature that causes a particular level of pain. However, even if the TRPV1-dependent shift in heat detection is about 1°C, at the end of the temperature ramp to 52°C, most heat-induced pain remains unexplained. This difference between species reopens the quest for the molecular safety net for the detection of noxious heat in humans.
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Calor , Canales Catiónicos TRPV , Sensación Térmica , Humanos , Canales Catiónicos TRPV/antagonistas & inhibidores , Canales Catiónicos TRPV/metabolismo , Masculino , Adulto , Animales , Femenino , Ratones , Estudios Cruzados , Dolor , Canal Catiónico TRPA1/metabolismo , Canal Catiónico TRPA1/genética , Canal Catiónico TRPA1/antagonistas & inhibidores , Adulto JovenRESUMEN
The pharmacodynamic effects of lysergic acid diethylamide (LSD) are diverse and different in different individuals. Effects of other psychoactive substances have been shown to be critically influenced by non-pharmacological factors such as personality traits and mood states. The aim of this study was to determine pharmacological and psychological predictors of the LSD effects in healthy human subjects. This analysis is based on nine double-blind, placebo-controlled, cross-over studies with a total of 213 healthy subjects receiving between 25-200 µg LSD. The influence of sex, age, dose, body weight, pharmacogenetic, drug experience, personality, setting, and mood before drug intake on the peak autonomic and total subjective responses to LSD was investigated using multiple linear mixed effects models and Least Absolute Shrinkage and Selection Operator regression. Results were adjusted for LSD dose and corrected for multiple testing. LSD dose emerged as the most influential predictor, exhibiting a positive correlation with most response variables. Pre-drug mental states such as "Well-Being", "Emotional Excitability", and "Anxiety" were also important predictor for a range of subjective effects but also heart rate and body temperature. The trait "Openness to Experiences" was positively correlated with elevated ratings in "Oceanic Boundlessness" and mystical-type effects. Previous experiences with hallucinogens have been negatively associated with the overall altered state of consciousness and particularly with "Anxious Ego Dissolution". Acute anxiety negatively correlated with the genetically determined functionality of the Cytochrome 2D6 enzyme. In summary, besides the amount of drug consumed, non-pharmacological factors such as personal traits and current mood also significantly predicted the subjective drug experience. Sex and body weight were not significant factors in influencing the drug experience.
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Afecto , Estudios Cruzados , Alucinógenos , Dietilamida del Ácido Lisérgico , Humanos , Dietilamida del Ácido Lisérgico/farmacología , Dietilamida del Ácido Lisérgico/administración & dosificación , Masculino , Femenino , Adulto , Alucinógenos/administración & dosificación , Alucinógenos/farmacología , Método Doble Ciego , Adulto Joven , Afecto/efectos de los fármacos , Voluntarios Sanos , Frecuencia Cardíaca/efectos de los fármacos , Personalidad , Persona de Mediana Edad , Relación Dosis-Respuesta a Droga , AdolescenteRESUMEN
BACKGROUND: This study examined (i) adaptations in muscle activity following perturbation-based balance training (PBT) using treadmill belt-accelerations or PBT using walkway trips and (ii) whether adaptations during treadmill PBT transfer to a walkway trip. METHODS: Thirty-eight older people (65+ years) undertook two PBT sessions, including 11 treadmill belt-accelerations and 11 walkway trips. Surface electromyography (EMG) was measured bilaterally on the rectus femoris (RF), tibialis anterior (TA), semitendinosus (ST) and gastrocnemius medial head (GM) during the first (T1) and eleventh (T11) perturbations. Adaptations (within-subjects - 1st vs 11th perturbations for treadmill and walkway PBT) and their transfer (between-subjects - 1st walkway trip after treadmill PBT vs 1st walkway trip with no prior training) effects were examined for the EMG parameters. RESULTS: Treadmill PBT reduced post-perturbation peak muscle activation magnitude (left RF, TA, ST, right RF, ST, GM), onset latency (right TA), time to peak (right RF) and co-contraction index (knee muscles) (P < 0.05). Walkway PBT reduced post-trip onset latencies (right TA, ST), peak magnitude (left ST, right GM), time to peak (right RF, ST) and pre-perturbation muscle activity (right TA) (P < 0.05). Those who undertook treadmill PBT were not different to those without prior training during the first walkway trip (P > 0.05). CONCLUSIONS: Both treadmill and walkway PBT induced earlier initiation and peak activation of right limb muscles responsible for the first recovery step. Treadmill PBT also reduced co-contraction of the knee muscles. Adaptations in muscle activity following treadmill PBT did not transfer to a walkway trip.