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1.
J Infect Chemother ; 24(6): 434-442, 2018 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-29530544

RESUMEN

The objective of this open-label, randomised (i.e. 2:1 ratio), Phase 3 study was to compare the efficacy and safety of tedizolid phosphate 200 mg, once-daily treatment with that of linezolid 600 mg, twice-daily treatment for 7-14 days in Japanese adult patients (N = 125) with skin and soft tissue infections (SSTIs) and/or for 7-21 days for those with SSTI-related bacteraemia, caused by confirmed or highly suspected methicillin-resistant Staphylococcus aureus (MRSA). Primary outcome was clinical cure rate at test-of-cure (TOC, in SSTI: 7-14 days, in bacteraemia: 4-6 weeks after end-of-therapy [EOT]) time point in the microbiologically evaluable MRSA (ME-MRSA) population (N = 39). Secondary endpoints were clinical and microbiological response rates at EOT. Safety parameters were evaluated in the safety analysis population up to follow up. Data analysis was descriptive in nature. Baseline characteristics of patients were similar between treatment groups. At TOC in the ME-MRSA population, clinical cure rate was similar in tedizolid phosphate (92.6%) and linezolid (88.9%) groups. At EOT, clinical cure (tedizolid phosphate: 93.1%, linezolid: 90.0%) and microbiological success (tedizolid phosphate: 93.1%, linezolid: 100.0%) rates were similar in the ME-MRSA population. Both treatments were well tolerated; overall treatment-emergent adverse events (TEAEs) in tedizolid phosphate (79.5%) and linezolid (75.6%) treatment groups were similar. Drug-related TEAEs were numerically lower with tedizolid phosphate versus linezolid (30.1%; 39.0%, respectively), as well as gastrointestinal (21.7%; 26.8%) and myelosuppression-related (2.4%; 22.0%) TEAEs. One death occurred in the linezolid group. Tedizolid phosphate may be an appropriate antibiotic for the treatment of SSTIs in Japanese adult patients. International clinical trial registration number: NCT01967225. Japanese clinical trial registration number: JapicCTI-132308.


Asunto(s)
Antibacterianos/farmacocinética , Linezolid/farmacocinética , Organofosfatos/farmacocinética , Oxazoles/farmacocinética , Enfermedades Cutáneas Bacterianas/tratamiento farmacológico , Infecciones de los Tejidos Blandos/tratamiento farmacológico , Anciano , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Bacteriemia/tratamiento farmacológico , Femenino , Humanos , Japón , Linezolid/administración & dosificación , Linezolid/uso terapéutico , Masculino , Staphylococcus aureus Resistente a Meticilina/efectos de los fármacos , Organofosfatos/administración & dosificación , Organofosfatos/uso terapéutico , Oxazoles/administración & dosificación , Oxazoles/uso terapéutico , Estudios Prospectivos , Resultado del Tratamiento
2.
Circ J ; 80(5): 1113-22, 2016 Apr 25.
Artículo en Inglés | MEDLINE | ID: mdl-27074824

RESUMEN

BACKGROUND: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, was evaluated in Japanese patients with heart failure (HF) with reduced ejection fraction and chronic kidney disease and/or diabetes mellitus. METHODS AND RESULTS: ARTS-HF Japan was a randomized, double-blind, phase 2b study. Patients (n=72) received oral, once-daily (o.d.) finerenone (2.5, 5, 7.5, 10 or 15 mg, up-titrated to 5, 10, 15, 20, or 20 mg, respectively, on day 30) or eplerenone (25 mg every other day, increased to 25 mg o.d. on day 30, and 50 mg on day 60) for 90 days. The primary endpoint was the proportion of individuals with a decrease of >30% in plasma NT-proBNP at day 90. Safety endpoints included the incidence of hyperkalemia. Decreases in NT-proBNP occurred in 23.1% of patients in the eplerenone group and 15.4%, 23.1%, 45.5%, 27.3% and 45.5% in the 2.5→5 mg, 5→10 mg, 7.5→15 mg, 10→20 mg and 15→20 mg finerenone groups, respectively (all P=NS). Mean changes in serum potassium levels were similar between groups. CONCLUSIONS: Because of the small sample size, limited conclusions can be drawn. Considering the results of ARTS-HF and that finerenone was well tolerated in Japanese patients in ARTS-HF Japan, the safety and efficacy of finerenone should be further explored in a large outcomes trial including Japanese patients. (Circ J 2016; 80: 1113-1122).


Asunto(s)
Insuficiencia Cardíaca/tratamiento farmacológico , Naftiridinas/administración & dosificación , Insuficiencia Renal Crónica/tratamiento farmacológico , Espironolactona/análogos & derivados , Adulto , Enfermedad Crónica , Diabetes Mellitus , Método Doble Ciego , Eplerenona , Insuficiencia Cardíaca/complicaciones , Humanos , Hiperpotasemia/inducido químicamente , Japón , Naftiridinas/efectos adversos , Naftiridinas/uso terapéutico , Péptido Natriurético Encefálico/sangre , Seguridad del Paciente , Fragmentos de Péptidos/sangre , Insuficiencia Renal Crónica/complicaciones , Espironolactona/administración & dosificación , Espironolactona/efectos adversos , Espironolactona/uso terapéutico
4.
Thromb J ; 13: 2, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-25717286

RESUMEN

BACKGROUND: The global EINSTEIN DVT and PE studies compared rivaroxaban (15 mg twice daily for 3 weeks followed by 20 mg once daily) with enoxaparin/vitamin K antagonist therapy and demonstrated non-inferiority for efficacy and superiority for major bleeding. Owing to differences in targeted anticoagulant intensities in Japan, Japanese patients were not enrolled into the global studies. Instead, a separate study of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in Japanese patients was conducted, which compared the Japanese standard of care with a reduced dose of rivaroxaban. METHODS: We conducted an open-label, randomized trial that compared 3, 6, or 12 months of oral rivaroxaban alone (10 mg twice daily or 15 mg twice daily for 3 weeks followed by 15 mg once daily) with activated partial thromboplastin time-adjusted intravenous unfractionated heparin (UFH) followed by warfarin (target international normalized ratio 2.0; range 1.5-2.5) in patients with acute, objectively confirmed symptomatic DVT and/or PE. Patients were assessed for the occurrence of symptomatic recurrent venous thromboembolic events or asymptomatic deterioration and bleeding. RESULTS: Eighty-one patients were assigned to rivaroxaban and 19 patients to UFH/warfarin. Three patients were excluded because of serious non-compliance issues. The composite of symptomatic venous thromboembolic events or asymptomatic deterioration occurred in 1 (1.4%) rivaroxaban patient and in 1 (5.3%) UFH/warfarin patient (absolute risk difference, 3.9% [95% confidence interval, -3.4-23.8]). No major bleeding occurred during study treatment. Clinically relevant non-major bleeding occurred in 6 (7.8%) patients in the rivaroxaban group and 1 (5.3%) patient in the UFH/warfarin group. CONCLUSIONS: The findings of this study in Japanese patients with acute DVT and/or PE suggest a similar efficacy and safety profile with rivaroxaban and control treatment, consistent with that of the worldwide EINSTEIN DVT and PE program. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01516840 and NCT01516814.

5.
Circ J ; 78(6): 1349-56, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24705469

RESUMEN

BACKGROUND: The J-ROCKET AF study found that rivaroxaban was non-inferior to warfarin with respect to the principal safety outcome in patients with atrial fibrillation (AF). The aim of this subgroup analysis was to assess the safety and efficacy of rivaroxaban and warfarin in relation to patient age. METHODS AND RESULTS: A total of 39.0% were elderly (aged ≥75 years). In elderly patients, the principal safety outcome occurred at 25.05%/year with rivaroxaban vs. 16.95%/year on warfarin (hazard ratio [HR], 1.49; 95% confidence interval [CI]: 1.02-2.16), whereas the primary efficacy endpoint occurred at 2.18%/year vs. 4.25%/year (HR, 0.51; 95% CI: 0.20-1.27), respectively. There were significant interactions in the principal safety outcomes of rivaroxaban compared with warfarin between the elderly and non-elderly groups, but not in the primary efficacy endpoints (P=0.04 and 0.82 for both interactions, respectively). Furthermore, in elderly patients, in the rivaroxaban group there was a trend to increase the principal safety outcome regardless of renal function. In elderly patients with preserved renal function, however, patients on rivaroxaban had a marginally favorable trend in the primary efficacy endpoint incidence rate compared with patients on warfarin. CONCLUSIONS: There is a need to carefully consider the risks and benefits of therapy with rivaroxaban in elderly patients with non-valvular AF.


Asunto(s)
Envejecimiento , Fibrilación Atrial/tratamiento farmacológico , Inhibidores del Factor Xa , Morfolinas , Tiofenos , Warfarina , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Morfolinas/administración & dosificación , Morfolinas/efectos adversos , Estudios Prospectivos , Factores de Riesgo , Rivaroxabán , Tiofenos/administración & dosificación , Tiofenos/efectos adversos , Warfarina/administración & dosificación , Warfarina/efectos adversos
6.
J Stroke Cerebrovasc Dis ; 23(2): 379-83, 2014 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23954611

RESUMEN

BACKGROUND: Results from a trial of rivaroxaban versus warfarin in 1280 Japanese patients with atrial fibrillation (J-ROCKET AF) revealed that rivaroxaban was noninferior to warfarin with respect to the principal safety outcome. In this subanalysis, we investigated the safety and efficacy of rivaroxaban and warfarin in relation to patients' CHADS2 scores. RESULTS: The mean CHADS2 score was 3.25, and the most frequent scores were 3 and 4. No statistically significant interactions were observed between principal safety outcome event rates and CHADS2 scores with respect to treatment groups (P value for interaction = .700). Irrespective of stratification into moderate- and high-risk groups based on CHADS2 scores of 2 and 3 or more, respectively, no differences in principal safety outcome event rates were observed between rivaroxaban- and warfarin-treated patients (moderate-risk group: hazard ratio [HR], 1.06; 95% confidence interval [CI], .58-1.95; high-risk group: HR, 1.11; 95% CI, .86-1.45; P value for interaction = .488). The primary efficacy end point rate in the rivaroxaban-treated group was numerically lower than in the warfarin-treated group, regardless of risk group stratification (moderate-risk group: HR, .46; 95% CI, .09-2.37; high-risk group: HR, .49; 95% CI, .22-1.11; P value for interaction = .935). CONCLUSION: This subanalysis indicated that the safety and efficacy of rivaroxaban compared with warfarin were similar, regardless of CHADS2 score.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Morfolinas/uso terapéutico , Accidente Cerebrovascular/prevención & control , Tiofenos/uso terapéutico , Warfarina/uso terapéutico , Anciano , Anticoagulantes/efectos adversos , Pueblo Asiatico , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/etnología , Fibrilación Atrial/mortalidad , Supervivencia sin Enfermedad , Método Doble Ciego , Femenino , Humanos , Japón/epidemiología , Estimación de Kaplan-Meier , Masculino , Morfolinas/efectos adversos , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Rivaroxabán , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/etnología , Accidente Cerebrovascular/mortalidad , Tiofenos/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Warfarina/efectos adversos
7.
J Stroke Cerebrovasc Dis ; 23(5): 1142-7, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24189454

RESUMEN

BACKGROUND: The risk factors that have been identified for bleeding events with rivaroxaban are predominantly the same as those predicting thromboembolic ones in patients with atrial fibrillation (AF). Our aim was to determine the net clinical benefit (NCB) from the results of the J-ROCKET AF trial, in which rivaroxaban was compared with warfarin in Japanese patients with AF. METHODS: Two strategies were adopted to quantify the NCB. First, the NCB was calculated as the number of ischemic strokes avoided with anticoagulation minus the number of excess intracranial hemorrhage (ICH) with a weight of 1.5. Second, the composite end point of major bleeding events and secondary efficacy end points (stroke, noncentral nervous system systemic embolism, myocardial infarction and death) to ascertain the NCB were established. Subgroup analysis by CHADS2 score or creatinine clearance was also performed. RESULTS: The adjusted NCB, which was given a weight of 1.5 for ICH, was nominally significant in favor of rivaroxaban therapy (difference in incidence rate -2.13; 95% confidence interval [CI]: -.26 to -3.99). Furthermore, the event rate of the composite end point tended to be lower in patients treated with rivaroxaban than in those treated with warfarin (rivaroxaban: 4.97% per year, warfarin: 6.11% per year; difference in incidence rate: -1.14; 95% CI: -3.40 to 1.12). The event rate of the composite end point tended to be consistently low in patients treated with rivaroxaban in the subanalysis by CHADS2 score and renal function. CONCLUSION: Analysis of the NCB supports that rivaroxaban therapy provides clinical benefit for Japanese patients with AF.


Asunto(s)
Anticoagulantes/uso terapéutico , Pueblo Asiatico , Fibrilación Atrial/tratamiento farmacológico , Isquemia Encefálica/prevención & control , Inhibidores del Factor Xa/uso terapéutico , Morfolinas/uso terapéutico , Accidente Cerebrovascular/prevención & control , Tiofenos/uso terapéutico , Warfarina/uso terapéutico , Anticoagulantes/efectos adversos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/etnología , Fibrilación Atrial/mortalidad , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/etnología , Isquemia Encefálica/mortalidad , Método Doble Ciego , Inhibidores del Factor Xa/efectos adversos , Humanos , Hemorragias Intracraneales/inducido químicamente , Hemorragias Intracraneales/etnología , Japón , Morfolinas/efectos adversos , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Rivaroxabán , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/etnología , Accidente Cerebrovascular/mortalidad , Tiofenos/efectos adversos , Factores de Tiempo , Resultado del Tratamiento , Warfarina/efectos adversos
8.
Sci Rep ; 14(1): 7968, 2024 04 04.
Artículo en Inglés | MEDLINE | ID: mdl-38575648

RESUMEN

Fear of doctors is a common source of distress among infants; however, the underlying sources of this distress are unknown. To investigate the doctor-infant relationship, the behaviors of 61 healthy infants (176-617 days old) were observed in a simulated examination room. Their behaviors and electrocardiograms were recorded. Two groups of infants were analyzed: those who cried and those who did not. When an experimenter dressed in the doctor's attire entered the room, all 9 infants who were crying (14.8% of all infants) stopped crying, all infants gazed at the experimenter, and their mean heart rate (HR) decreased. After the auscultation started, 29.5% of all infants cried, and the HRs of infants who cried were higher than those of infants who did not cry. During the auscultation, 80.0% of infants who cried averted from the experimenter, while 34.4% of infants who did not cry. Within 5 s of gazing at the stethoscope, the number of infants who cried increased from 3 to 12, and their mean HR also increased. Our findings suggest that the fear of doctors is not due to the appearance of doctors but rather to specific actions performed by doctors, such as auscultation. Infants may regard a doctor's appearance as a source of interest. Furthermore, a stethoscope is a possible trigger for infants' crying. These behavioral observations suggest the potential for patient-centered care for infants.


Asunto(s)
Llanto , Electrocardiografía , Trastornos Fóbicos , Lactante , Humanos
9.
Circ J ; 77(3): 632-8, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-23229461

RESUMEN

BACKGROUND: In the Japanese Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (J-ROCKET AF) study, rivaroxaban 15 mg once daily was given to patients with creatinine clearance (CrCl) ≥ 50 ml/min (preserved renal function), and was reduced to 10mg once daily in patients with CrCl 30-49 ml/min (moderate renal impairment). The aim of this subanalysis was to assess the safety and efficacy of the adjusted dose of rivaroxaban compared with warfarin in a cohort with moderate renal impairment. METHODS AND RESULTS: Compared with patients with preserved renal function, those with moderate renal impairment (22.2% of all randomized patients) had higher rates of bleeding and stroke events irrespective of study treatment. Among those with moderate renal impairment, the principal safety endpoint occurred at 27.76%/year with rivaroxaban vs. 22.85%/year with warfarin (hazard ratio [HR], 1.22; 95% confidence interval [CI]: 0.78-1.91) and the rate of the primary efficacy endpoint was 2.77%/year vs. 3.34%/year (HR, 0.82; 95% CI: 0.25-2.69), respectively. There were no significant interactions between renal function and study treatment in the principal safety and the primary efficacy endpoints (P=0.628, 0.279 for both interactions, respectively). CONCLUSIONS: The safety and efficacy of rivaroxaban vs. warfarin were consistent in patients with moderate renal impairment and preserved renal function.


Asunto(s)
Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Pueblo Asiatico , Fibrilación Atrial/tratamiento farmacológico , Morfolinas/efectos adversos , Morfolinas/uso terapéutico , Insuficiencia Renal/inducido químicamente , Accidente Cerebrovascular/prevención & control , Tiofenos/efectos adversos , Tiofenos/uso terapéutico , Administración Oral , Anciano , Anciano de 80 o más Años , Anticoagulantes/farmacología , Fibrilación Atrial/fisiopatología , Creatinina/metabolismo , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Femenino , Humanos , Japón , Riñón/efectos de los fármacos , Riñón/metabolismo , Riñón/fisiopatología , Masculino , Persona de Mediana Edad , Morfolinas/farmacología , Insuficiencia Renal/metabolismo , Insuficiencia Renal/fisiopatología , Reproducibilidad de los Resultados , Factores de Riesgo , Rivaroxabán , Tiofenos/farmacología , Resultado del Tratamiento , Warfarina/efectos adversos , Warfarina/uso terapéutico
10.
J Stroke Cerebrovasc Dis ; 22(8): 1317-25, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-23352688

RESUMEN

BACKGROUND: The overall analysis of the rivaroxaban versus warfarin in Japanese patients with atrial fibrillation (J-ROCKET AF) trial revealed that rivaroxaban was not inferior to warfarin with respect to the primary safety outcome. In addition, there was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban compared with warfarin. METHODS: In this subanalysis of the J-ROCKET AF trial, we investigated the consistency of safety and efficacy profile of rivaroxaban versus warfarin among the subgroups of patients with previous stroke, transient ischemic attack, or non-central nervous system systemic embolism (secondary prevention group) and those without (primary prevention group). RESULTS: Patients in the secondary prevention group were 63.6% of the overall population of J-ROCKET AF. In the secondary prevention group, the rate of the principal safety outcome (% per year) was 17.02 in rivaroxaban-treated patients and 18.26 in warfarin-treated patients (hazard ratio [HR] 0.95; 95% confidence interval [CI] 0.70-1.29), while the rate of the primary efficacy endpoint was 1.66 in rivaroxaban-treated patients and 3.25 in warfarin-treated patients (HR 0.51; 95% CI 0.23-1.14). There were no significant interactions in the principal safety and the primary efficacy endpoints of rivaroxaban compared to warfarin between the primary and secondary prevention groups (P=.090 and .776 for both interactions, respectively). CONCLUSIONS: The safety and efficacy profile of rivaroxaban compared with warfarin was consistent among patients in the primary prevention group and those in the secondary prevention group.


Asunto(s)
Anticoagulantes/uso terapéutico , Fibrilación Atrial/complicaciones , Fibrilación Atrial/prevención & control , Inhibidores del Factor Xa/uso terapéutico , Morfolinas/uso terapéutico , Accidente Cerebrovascular/prevención & control , Tiofenos/uso terapéutico , Warfarina/uso terapéutico , Anciano , Anciano de 80 o más Años , Anticoagulantes/efectos adversos , Pueblo Asiatico , Método Doble Ciego , Inhibidores del Factor Xa/efectos adversos , Femenino , Humanos , Ataque Isquémico Transitorio/complicaciones , Masculino , Persona de Mediana Edad , Morfolinas/efectos adversos , Estudios Prospectivos , Rivaroxabán , Prevención Secundaria , Tiofenos/efectos adversos , Resultado del Tratamiento , Warfarina/efectos adversos
11.
Circ J ; 76(9): 2104-11, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22664783

RESUMEN

BACKGROUND: The global ROCKET AF study evaluated once-daily rivaroxaban vs. warfarin for stroke and systemic embolism prevention in patients with atrial fibrillation (AF). A separate trial, J-ROCKET AF, compared the safety of a Japan-specific rivaroxaban dose with warfarin administered according to Japanese guidelines in Japanese patients with AF. METHODS AND RESULTS: J-ROCKET AF was a prospective, randomized, double-blind, phase III trial. Patients (n=1,280) with non-valvular AF at increased risk for stroke were randomized to receive 15 mg once-daily rivaroxaban or warfarin dose-adjusted according to Japanese guidelines. The primary objective was to determine non-inferiority of rivaroxaban against warfarin for the principal safety outcome of major and non-major clinically relevant bleeding, in the on-treatment safety population. The primary efficacy endpoint was the composite of stroke and systemic embolism. Non-inferiority of rivaroxaban to warfarin was confirmed; the rate of the principal safety outcome was 18.04% per year in rivaroxaban-treated patients and 16.42% per year in warfarin-treated patients (hazard ratio [HR] 1.11; 95% confidence interval 0.87-1.42; P<0.001 [non-inferiority]). Intracranial hemorrhage rates were 0.8% with rivaroxaban and 1.6% with warfarin. There was a strong trend for a reduction in the rate of stroke/systemic embolism with rivaroxaban vs. warfarin (HR, 0.49; P=0.050). CONCLUSIONS: J-ROCKET AF demonstrated the safety of a Japan-specific rivaroxaban dose and supports bridging the global ROCKET AF results into Japanese clinical practice.


Asunto(s)
Anticoagulantes/administración & dosificación , Fibrilación Atrial/complicaciones , Embolia/prevención & control , Morfolinas/administración & dosificación , Accidente Cerebrovascular/prevención & control , Tiofenos/administración & dosificación , Warfarina/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Anticoagulantes/efectos adversos , Fibrilación Atrial/tratamiento farmacológico , Método Doble Ciego , Embolia/etiología , Femenino , Humanos , Hemorragias Intracraneales/inducido químicamente , Masculino , Persona de Mediana Edad , Morfolinas/efectos adversos , Estudios Prospectivos , Rivaroxabán , Accidente Cerebrovascular/etiología , Tiofenos/efectos adversos , Warfarina/efectos adversos
12.
Front Pediatr ; 10: 902012, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35935356

RESUMEN

This study aimed to develop an automatic classifier for the identification of severe sleep disorders that require immediate intervention in children. Our study assessed 7,008 children (age: 0-83 months) in Japan, whose parents and nursery teachers recorded their 14-day sleep patterns. Sleep quality was assessed by pediatricians and scored as 1 (no severe sleep disorder) or 0 (severe sleep disorder). Discriminant analysis was performed for each age group using sleep quality (0 or 1) as the dependent variable and variables in the 14-day sleep log as independent variables. A stepwise method was used to select the independent variables to build the best model. The accuracy of the discriminant analysis for the age groups ranged from 71.3 to 97.3%. In summary, we developed an automatic classifier with sufficient application value to screen for severe sleep disorders in children. In the future, this classifier can be used to rapidly determine the presence or absence of severe sleep disorders in children based on their 14-day sleep logs, thus allowing immediate intervention.

13.
R Soc Open Sci ; 9(8): 220592, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-35991332

RESUMEN

Gaze following (GF) is fundamental to central aspects of human sociocognitive development, such as acquiring language and cultural learning. Studies have shown that infant GF is not a simple reflexive orientation to an adult's eye movement. By contrast, infants adaptively modulate GF behaviour depending on the social context. However, arguably, the neurophysiological mechanisms underlying contextual modulation of GF remain somewhat unexplored. In this study, we tested the proposition about whether the contextual modulation of infant GF is mediated by the infant's heart rate (HR), which indicates the infant's physiological arousal. Forty-one 6- to 9-month-old infants participated in this study, and infants observed either a reliable face, which looked towards the location of an object, or an unreliable face, which looked away from the location of an object. Thereafter, the infants watched a video of the same model making eye contact or not making any ostensive signals, before shifting their gaze towards one of the two objects. We revealed that reliability and eye contact acted independently to increase HR, which then fully mediates the effects of these social cues on the frequency of GF. Results suggest that each social cue independently enhances physiological arousal, which then accumulatively predicts the likelihood of infant GF behaviour.

15.
Front Psychol ; 12: 786391, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34975680

RESUMEN

Infant crying is an important signal for their survival and development, and maternal beliefs about crying predict responsiveness to crying. Most studies have considered caregivers' reactions to crying to be fixed, and it is unclear how they change with their caregiving experience. Additionally, it has recently been suggested that there is a bidirectional relationship between changes in mothers' beliefs about crying and infants' temperament. This study examined that relationship using a longitudinal study design. Maternal beliefs about crying and infant temperament of 339 Asian first-time mothers (mean age = 28.7 years, SD = 4.1) were measured at 1-month intervals over 4 months. There were 289 participants in Wave 2, 240 in Wave 3, and 164 in Wave 4. Prior to the main survey, we conducted a pre-survey to confirm the reliability and validity of the Japanese version of the Infant Crying Questionnaire. The results showed that parent-oriented beliefs, which focus on the caregiver rather than the crying infant, increased in mothers who had infants aged 3 months or older at Wave 1. We also found that the process of change in maternal beliefs was not uniform, and that infants high on surgency predicted changes in maternal beliefs about infant crying. Longitudinal studies of caregivers' changes, such as the present study, are expected to contribute to understanding the co-development of caregivers and infants.

16.
Front Psychol ; 12: 729302, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34721190

RESUMEN

Efficient data collection in developmental studies is facing challenges due to the decreased birth rates in many regions, reproducibility problems in psychology research, and the COVID-19 pandemic. Here, we propose a novel platform for online developmental science research, the Baby's Online Live Database (BOLD), which extends the scope of the accessible participant pool, simplifies its management, and enables participant recruitment for longitudinal studies. Through BOLD, researchers can conduct online recruitment of participants preregistered to BOLD simply by specifying their attributes, such as gender and age, and direct the participants to dedicated webpages for each study. Moreover, BOLD handles participant recruitment and reward payment, thereby freeing researchers from the labor of participant management. BOLD also allows researchers the opportunity to access data that were collected from participants in previous research studies. This enables researchers to carry out longitudinal analyses at a relatively low cost. To make BOLD widely accessible, a consortium was formed within the Japan Society of Baby Science, where members from diverse research groups discussed the blueprint of this system. Once in full-scaled operation, BOLD is expected to serve as a platform for various types of online studies and facilitate international collaboration among developmental scientists in the near future.

17.
J Oleo Sci ; 70(12): 1829-1838, 2021 Dec 03.
Artículo en Inglés | MEDLINE | ID: mdl-34759112

RESUMEN

The pathogenic mechanism of dementia is still unknown, and the fundamental treatment remains to be established. Thus, there is growing interest in preventing dementia through diet. One of the functional ingredients attracting attention is docosahexaenoic acid. We conducted a 12-month, randomized, double-blind, placebo-controlled clinical trial in healthy elderly Japanese individuals with a Mini-Mental State Examination score of 28 or higher at baseline using a docosahexaenoic acid-enriched milk beverage containing 297 mg docosahexaenoic acid and 137 mg eicosapentaenoic acid. Consumption of a docosahexaenoic acid-enriched milk beverage increased the fatty acid levels of docosahexaenoic acid and eicosapentaenoic acid in erythrocyte membranes, which was the primary outcome of this study. Moreover, intake of this beverage prevented age-related cognitive decline and decreased serum bone resorption marker levels. Our data demonstrate that, even at a low dose, long-term daily intake of docosahexaenoic acid prevents dementia and may show beneficial effect on bone health.


Asunto(s)
Fosfatasa Alcalina/sangre , Resorción Ósea/diagnóstico , Resorción Ósea/prevención & control , Envejecimiento Cognitivo , Disfunción Cognitiva/etiología , Disfunción Cognitiva/prevención & control , Demencia/prevención & control , Suplementos Dietéticos , Ácidos Docosahexaenoicos/administración & dosificación , Ingestión de Alimentos/fisiología , Leche , Fosfatasa Ácida Tartratorresistente/sangre , Anciano , Animales , Pueblo Asiatico , Biomarcadores/sangre , Demencia/etiología , Ácidos Docosahexaenoicos/sangre , Método Doble Ciego , Ácido Eicosapentaenoico/administración & dosificación , Membrana Eritrocítica/metabolismo , Femenino , Humanos , Masculino , Persona de Mediana Edad
18.
PLoS One ; 15(2): e0227880, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32084136

RESUMEN

This study measured automatic walking synchronization and how it associates with social impression. Previous studies discovered positive social consequence of motor synchrony with ecological paradigms (e.g. body movement synchrony between therapists and patients in clinical sessions, and the synchrony of side-by-side walkers). However, most studies of joint movement with high ecological validity face the same challenge, namely that conversations between participants might be the main or a partial contributor to the observed social benefits, as conversation is well documented to promote understanding and motor synchronization. We addressed this issue by using a novel paradigm to remove the conversation component and examined how synchrony per se interacted with social impression. Participants were paired to walk side by side in silence (i.e. without conversation) and their social impression toward each other was rated before/after the paired walk. Our results showed that walkers' first impression was positively associated with their step synchronization rate in the silent paired walk. Together with past findings, the bi-directional relation between body entrainment and social functions suggests that implicit nonverbal communication plays a significant role in providing a basis for interpersonal interaction.


Asunto(s)
Relaciones Interpersonales , Caminata/fisiología , Aceleración , Comunicación , Intervalos de Confianza , Femenino , Humanos , Juicio , Masculino , Movimiento (Física) , Ajuste Social , Análisis y Desempeño de Tareas , Factores de Tiempo , Percepción del Tiempo , Adulto Joven
19.
J Med Econ ; 23(12): 1379-1388, 2020 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-32936057

RESUMEN

OBJECTIVE: To compare the hospital length of stay (LOS) between rivaroxaban and warfarin in hospitalized acute stroke patients with non-valvular atrial fibrillation (NVAF) in Japan. METHODS: This was a retrospective, observational study using a Japanese hospital claims database. Data of NVAF patients who were started on oral anticoagulant (OAC) treatment during hospitalization were extracted and LOS-OAC (period from the initiation of index OAC therapy to the end of hospitalization or censoring date) and medical costs were compared between rivaroxaban and warfarin treatments. To compare LOS-OAC, a time-to-event analysis was performed using the Kaplan-Meier method. The analysis period was from April 2012 to December 2015. RESULTS: This study included 773 rivaroxaban users and 1077 warfarin users. After the propensity score matching, 546 patients for each treatment constituted the matched cohorts. Although the rivaroxaban users had a similar LOS-OAC to warfarin users (median, 18 vs. 19 days, p = .657) in the matched cohorts, 3 days shorter LOS-OAC was observed in the rivaroxaban users (median, 17 vs. 20 days, p = .043) after IPTW adjustment. Subgroup analysis by the severity of stroke after IPTW adjustment demonstrated that rivaroxaban users had a shorter LOS-OAC than warfarin users among patients with mild (median, 10 vs. 14 days) and moderate stroke severity (22 vs. 27 days), but not among those with severe stroke severity (26 vs. 25 days). LIMITATIONS: It is not possible to say that the only confounder was stroke severity and therefore other possible known and unknown confounders could not be ruled out. CONCLUSIONS: The rivaroxaban users had a 3-day shorter LOS-OAC after IPTW-adjustment. Using rivaroxaban was associated with 4-5 days shorter LOS-OAC than using warfarin in patients with mild or moderate stroke, though treatment selection did not have a large impact in patients with severe stroke.


Asunto(s)
Fibrilación Atrial , Isquemia Encefálica , Accidente Cerebrovascular Isquémico , Accidente Cerebrovascular , Anticoagulantes/uso terapéutico , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Isquemia Encefálica/tratamiento farmacológico , Hospitalización , Hospitales , Humanos , Tiempo de Internación , Estudios Retrospectivos , Rivaroxabán/uso terapéutico , Accidente Cerebrovascular/prevención & control , Warfarina/uso terapéutico
20.
Acta Psychol (Amst) ; 210: 103172, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32980633

RESUMEN

When walking alongside someone, you may feel that your legs move in synchrony with theirs. Recent studies have shown that walk-in-synch behaviour observed in natural settings occurs at a rate significantly greater than would be expected by chance, and that the amount of this synchrony is related to interpersonal impressions. However, in such natural settings, the existence of verbal conversations between paired walkers should affect the interpersonal impressions and the effect is not distinguished from the effect of walk-in-synch on the impressions so far. In the current study, we used the analysis of conversation and path analysis to discriminate these two effects (i.e., the effects of synchronization of walking and conversation on interpersonal impressions). Analysis of conversation during the walk revealed that the amount of utterance overlap and the number of turn-takings between two walkers as well as the synchronization of steps predicted their positive interpersonal impression, while synchronization of steps and these two conversational indices were not correlated with each other. We propose that interpersonal synchronization of body movements, such as synchronization of steps itself in paired walking, plays a role in fostering the development of interpersonal relationships.


Asunto(s)
Relaciones Interpersonales , Caminata , Comunicación , Humanos
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