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1.

Purpose

Community exercise programs can help maintain or improve health in cancer survivors. However, the most effective and feasible duration of a community exercise program for breast cancer survivors who are undergoing treatment is not known. This pre-post-design study evaluated the effects of the “Breast cancer patients Engaging in Activity while Undergoing Treatment” (BEAUTY) program on physical and psychosocial outcomes after 12 and 24 weeks.

Methods

BEAUTY is an ongoing community exercise and wellness program for breast cancer patients who are undergoing, or within 3 months of completing chemotherapy and radiation. Participants completed assessments at baseline, 12 weeks, and 24 weeks to measure body composition, hand-grip dynamometry, aerobic fitness, and flexibility. Self-report questionnaires assessed fatigue (FACIT-fatigue), cognitive function (FACT-cog), quality of life (QOL) (FACT-B), and depressive symptoms (CES-D). Main analyses were repeated measures general linear model for all outcomes.

Results

Assessments at all three time points were completed by N?=?63 participants. At 24 weeks, waist to hip ratio (p?=?.019), duration of the submaximal treadmill test (p?=?.013), and estimated VO2max (p?=?.018) improved compared to baseline. Fatigue improved at 24 compared to 12 weeks (p?=?.002). FACT-B scores improved at 24 weeks when compared to both baseline (p?=?.002) and 12 weeks (p?=?.001). Depressive symptoms improved compared to baseline (p?=?.05) and 12 weeks (p?=?.009).

Conclusions

Additional benefits were seen after 24 versus 12 weeks, suggesting that a longer duration exercise program during, or shortly after completing treatments for breast cancer, may be necessary to see improvements in fitness and psychosocial outcomes. Findings can be applied to community exercise and rehabilitation programs for breast cancer survivors.
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2.

Background

Parental social characteristics influence the use of emergency departments (ED) in the USA, but less is known about paediatric ED care-seeking in countries with national health insurance. This prospective study was designed to evaluate associations between parental care-seeking and social characteristics, with emphasis on impact of non-native origin, at a paediatric ED in Sweden, a European country providing paediatric healthcare free of charge.

Methods

Parents attending a paediatric ED at a large urban university hospital filled out a questionnaire on social characteristics and reasons for care-seeking. Information on patient characteristics and initial management was obtained from ED registers and patient records. Paediatric ED physicians assessed the medical appropriateness of each patient visit triaged for ED care.

Results

In total, 962 patient visits were included. Telephone healthline service before the paediatric ED visit was less often used by non-native parents (63/345 vs. 249/544, p?<?0.001). Low-aquity visits, triaged away from the ED, were more common among non-native parents (80/368 vs. 67/555, OR?=?1.66; p?=?0.018), and among those reporting lower abilities in the Swedish language (23/82 vs. 120/837, OR?=?2.66; p?=?0.003). Children of non-native parents were more often assessed by physicians not to require ED care (122/335 vs. 261/512, OR?=?0.70; p?=?0.028).

Conclusions

This study confirms more direct and less urgent use of paediatric ED care by parents of non-native origin or with limited abilities in the Swedish language, proposing that parental social characteristics influence paediatric ED care-seeking, also in a country with healthcare free of charge, and that specific needs of these groups should be better met by prehospital medical services.
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3.

Background

Nurses often have difficulties with using interdisciplinary stroke guidelines for patients with stroke as they do not focus sufficiently on nursing. Therefore, the Stroke Nursing Guideline (SNG) was developed and implemented. The aim of this study was to determine the implementation and feasibility of the SNG in terms of changes in documentation and use of the guideline in the care of stroke patients on Neurological and Rehabilitation wards, barriers and facilitators, and nurses’ and auxiliary nurses’ view of the implementation.

Methods

A sequential explorative mixed method design was used including pre-test post-test measures and post intervention focus groups interviews. For the quantitative part retrospective electronic record data of nursing care was collected from 78 patients and prospective measures with Barriers and Facilitators Assessment Instrument (BFAI) and Quality Indicator Tool (QIT) from 33 nursing staff including nurses and auxiliary nurses. In the qualitative part focus groups interviews were conducted with nursing staff on usefulness of the SNG and experiences with implementation.

Results

Improved nursing documentation was found for 23 items (N?=?37), which was significant for nine items focusing mobility (p?=?0.002, p?=?0.024, p?=?0.012), pain (p?=?0.012), patient teaching (p?=?0.001, p?=?0.000) and discharge planning (p?=?0.000, p?=?0.002, p?=?0.004). Improved guideline use was found for 20 QIT-items (N?=?30), with significant improvement on six items focusing on mobility (p?=?0.023), depression (p?=?0.033, p?=?0.025, p?=?0.046, p?=?0.046), discharge planning (p?=?0.012). Facilitating characteristics for change were significantly less for two of four BFAI-subscales, namely Innovation (p?=?0.019) and Context (p?=?0.001), whereas no change was found for Professional and Patient subscales. The findings of the focus group interviews showed the SNG to be useful, improving and providing consistency in care. The implementation process was found to be successful as essential components of nursing rehabilitation were defined and integrated into daily care.

Conclusion

Nursing staff found the SNG feasible and implementation successful. The SNG improved nursing care, with increased consistency and more rigorous functional exercises than before. The SNG provides nurses and auxiliary nurses with an important means for evidence based care for patients with stroke. Several challenges of implementing this complex nursing intervention surfaced which mandates ongoing attention.
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4.

Purpose

This study evaluated the effectiveness of a self-managed home-based moderate intensity walking intervention on psychosocial health outcomes among breast cancer patients undergoing chemotherapy.

Methods

The randomised controlled trial compared a self-managed, home-based walking intervention to usual care alone among breast cancer patients receiving chemotherapy. Outcome measures included changes in self-report measures of anxiety, depression, fatigue, self-esteem, mood and physical activity. Fifty participants were randomised to either the intervention group (n?=?25), who received 12 weeks of moderate intensity walking, or the control group (n?=?25) mid-way through chemotherapy. Participants in the intervention group were provided with a pedometer and were asked to set goals and keep weekly diaries outlining the duration, intensity and exertion of their walking. Levels of psychosocial functioning and physical activity were assessed pre- and post-intervention in both groups.

Results

The intervention had positive effects on fatigue (F?=?5.77, p?=?0.02), self-esteem (F?=?8.93, p?≤?0.001), mood (F?=?4.73, p?=?0.03) and levels of physical activity (x 2?=?17.15, p?=?0.0011) but not anxiety (F?=?0.90, p?=?0.35) and depression (F?=?0.26, p?=?0.60) as assessed using the HADS. We found an 80 % adherence rate to completing the 12-week intervention and recording weekly logs.

Conclusion

This self-managed, home-based intervention was beneficial for improving psychosocial well-being and levels of physical activity among breast cancer patients treated with chemotherapy.

Trial registration

Current Controlled Trials ISRCTN50709297.
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5.

Background

Female handball athletes are at a particular risk of sustaining lower extremity injuries. The study examines time-dependent adaptations of static and dynamic balance as potential injury risk factors to a specific warm-up program focusing on neuromuscular control.

Methods

Fourty one (24.0?±?5.9 years) female handball athletes were randomized to an intervention or control group. The intervention group implemented a 15-min specific neuromuscular warm-up program, three times per week for eleven weeks, whereas the control group continued with their regular warm-up. Balance was assessed at five time points. Measures included the star excursion balance test (SEBT), and center of pressure (COP) sway velocity during single-leg standing.

Results

No baseline differences existed between groups in demographic data. Adherence to neuromuscular warm-up was 88.7 %. Mean COP sway velocity decreased significantly over time in the intervention group (?14.4 %; p?<?.001), but not in the control group (?6.2 %; p?=?0.056). However, these effects did not differ significantly between groups (p?=?.098). Mean changes over time in the SEBT score were significantly greater (p?=?.014) in the intervention group (+5.48) compared to the control group (+3.45). Paired t-tests revealed that the first significant balance improvements were observed after 6 weeks of training.

Conclusions

A neuromuscular warm-up positively influences balance variables associated with an increased risk of lower extremity injuries in female handball athletes. The course of adaptations suggests that a training volume of 15 min, three times weekly over at least six weeks produces measurable changes.

Trial registration

Retrospectively registered on 4th October 2016. Registry: clinicaltrials.gov. Trial number: NCT02925377.
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6.

Purpose

The aim of this study was to clarify whether ultrasound quantitative methods were positively correlated with volume of ascites evaluated by whole abdominopelvic CT.

Methods

Sixty-eight patients with cirrhotic ascites were retrospectively analyzed. First, to confirm that virtual ultrasonography (VUS) is an alternative method to conventional ultrasound, 22 patients underwent both conventional ultrasonography and VUS. Second, the efficacy of US quantitative methods (3-point method, 4-point method, 5-point method, and Matsumoto’s method) was confirmed by VUS in 68 patients. We assessed whether the ascites volume predicted by VUS corresponded with that calculated by 3D-CT. Of the 68 patients, 23 patients were analyzed before and after administration of tolvaptan.

Results

The predictive volumes calculated by VUS were remarkably relative to those yielded by conventional US. Correlations between exact volume and those measured by VUS were significantly high (3-point method: r?=?0.882, p?<?0.001; 4-point method: r?=?0.797, p?<?0.001; 5-point method: r?=?0.836, p?<?0.001; Matsumoto’s method: r?=?0.453, p?<?0.001). Correlations between decreasing volume on 3D-CT and that measured by VUS were also significantly high in patients with administration of tolvaptan.

Conclusion

Ascites volume measured by ultrasound was effective, especially the 3-point and 5-point methods. It was useful to assess the efficacy of diuretics in cirrhotic patients.
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7.

Purpose

To evaluate extraocular orbital vessels with color Doppler ultrasound (CDU) and investigate the effects of severe obstructive sleep apnea (OSA) on retrobulbar blood flow.

Methods

Between February 2014 and September 2015, 30 patients with severe OSA (apnea–hypopnea index (AHI) > 30) and 28 controls were prospectively included in this study. Intraocular pressure (IOP) was measured with a Goldmann applanation tonometer, and CDU was used to evaluate the retrobulbar vessels.

Results

The mean AHI score for the OSA group was 63.2 ± 21.5 per hour. The IOP values were significantly higher in the severe OSA group (p < 0.05). The central retinal artery peak systolic velocity (PSV) (p < 0.05) and end-diastolic velocity (EDV) (p < 0.02), and the ophthalmic artery (OA) PSV and EDV, were found to be significantly lower in the OSA group (p < 0.05).

Conclusion

Severe OSA causes an increase in IOP and a decrease in flow velocity in the retrobulbar circulation.
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8.

Introduction

Tiotropium bromide has been widely used in clinical practice, while theophylline is another treatment option for chronic obstructive pulmonary disease (COPD). However, only a few relevant studies have investigated the long-term outcomes and efficacy of both in patients with COPD. We evaluated the effects of tiotropium and low-dose theophylline on stable COPD patients of groups B and D.

Methods

Eligible participants (n?=?170) were randomized and received either tiotropium 18 µg once daily with theophylline 100 mg twice daily (Group I) or tiotropium 18 µg once daily (Group II) for 6 months. COPD assessment test (CAT), modified Medical Research Council (mMRC) dyspnea scores and pulmonary function tests were measured before randomization and during the treatment.

Results

After 6 months of treatment, the CAT scores in both groups decreased significantly (11.41?±?3.56 and 11.08?±?3.05, p?<?0.0001). The changes of CAT (p?=?0.028) and mMRC scores (p?=?0.049) between the two groups differed after 1 month of treatment. In Group I, forced expiratory flow after 25% of the FVC% predicted (MEF25% pred) was significantly improved after 3 months (4.84?±?8.73%, p?<?0.0001) and 6 months (6.21?±?8.65%, p?<?0.0001). There was a significant difference in small airway function tests (MEF50% pred, MEF25% pred, and MMEF% pred) between the two groups after 6 month of treatment (p?=?0.003, p?<?0.0001, and p?=?0.021, respectively).

Conclusions

Tiotropium combined with low-dose theophylline significantly improved the symptoms and general health of patients with stable COPD of groups B and D after 6 months of follow-up. Additionally, this therapy also improved the indicators of small airway function.

Trial Registration

Chinese Clinical Trial Registry (Registry ID: ChiCTR1800019027).
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9.

Purpose

To introduce a new diagnostic parameter: the linear combination of apparent integrated backscatter and spectral centroid shift.

Methods

Ultrasonic backscatter measurements were performed at the calcanei of 1262 volunteers in vivo. The hip and spine bone mineral densities of the volunteers were measured using dual X-ray absorptiometry. The apparent integrated backscatter and spectral centroid shift were calculated. A new diagnostic parameter, i.e., the linear combination of apparent integrated backscatter and spectral centroid shift, was introduced and its correlation to bone mineral density was analyzed.

Results

The results show that the combination of apparent integrated backscatter and spectral centroid shift is significantly correlated to bone mineral density (R = 0.73–0.84, n = 1262, p < 0.05), and that this correlation is more significant than the correlation between the apparent integrated backscatter and bone mineral density or the correlation between spectral centroid shift and bone mineral density (R = 0.48–0.69, p < 0.05).

Conclusion

The combination of apparent integrated backscatter and spectral centroid shift can provide the complementary information of attenuation of the two parameters and predict more information about cancellous bone, and may be employed to assess cancellous bone status.
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10.

Background

Withholding analgesics in acute abdomen for fear of masking clinical features and impairing diagnosis and decision-making is still being practiced despite recent evidence to the contrary. This study assesses the effect of preoperative analgesia on clinical findings, clinical diagnosis, and decision-making in patients with non-trauma acute abdomen.

Method

This is a randomized, double-blind, placebo-controlled study using Tramal, a brand of tramadol, at the ED of LAUTECH Teaching Hospital Osogbo, Nigeria. Ninety-five patients between 18–60 years received Tramal (n?=?46) or placebo (n?=?49). The pain score, clinical findings, provisional diagnosis, and treatment plan were noted before and 15–20 min after administration of the analgesic or placebo. The final diagnosis arrived at after adequate investigation or operation was considered the gold standard. The pain scores, diagnosis, treatment plan, and decision between the two groups were compared. Statistical analysis was by SPSS 16. Results were considered statistically significant at p?<?0.05.

Results

Demography and case distribution were similar in both groups. The improvement in pain was greater in the Tramal group (p?=?0.001). The abdominal palpation findings were also better in the Tramal group (p?=?0.02). There were more changes in the diagnosis after use of Tramal (p?=?0.01). There were more changes in the decision in the Tramal group (p?=?0.03). Most of the changes in diagnosis and decision in the Tramal group were for the better.

Conclusion

The preoperative use of Tramal in acute abdomen improved the experience of pain and did not adversely affect the accuracy of the diagnosis or decision-making.
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11.

Purpose

Data on purpura fulminans (PF) in adult patients are scarce and mainly limited to meningococcal infections. Our aim has been to report the clinical features and outcomes of adult patients admitted in the intensive care unit (ICU) for an infectious PF, as well as the predictive factors for limb amputation and mortality.

Methods

A 17-year national multicenter retrospective cohort study in 55 ICUs in France from 2000 to 2016, including adult patients admitted for an infectious PF defined by a sudden and extensive purpura, together with the need for vasopressor support. Primary outcome variables included hospital mortality and amputation during the follow-up period (time between ICU admission and amputation, death or end of follow-up).

Results

Among the 306 included patients, 126 (41.2%; 95% CI 35.6–46.9) died and 180 (58.8%; 95% CI 53.3–64.3) survived during the follow-up period [13 (3–24) days], including 51/180 patients (28.3%, 95% CI 21.9–35.5) who eventually required limb amputations, with a median number of 3 (1–4) limbs amputated. The two predominantly identified microorganisms were Neisseria meningitidis (63.7%) and Streptococcus pneumoniae (21.9%). By multivariable Cox model, SAPS II [hazard-ratio (HR)?=?1.03 (1.02–1.04); p?<?0.001], lower leucocytes [HR 0.83 (0.69–0.99); p?=?0.034] and platelet counts [HR 0.77 (0.60–0.91); p?=?0.007], and arterial blood lactate levels [HR 2.71 (1.68–4.38); p?<?0.001] were independently associated with hospital death, while a neck stiffness [HR?0.51 (0.28–0.92); p?=?0.026] was a protective factor. Infection with Streptococcus pneumoniae [sub-hazard ratio 1.89 (1.06–3.38); p?=?0.032], together with arterial lactate levels and ICU admission temperature, was independently associated with amputation by a competing risks analysis.

Conclusion

Purpura fulminans carries a high mortality and morbidity. Pneumococcal PF leads to a higher risk of amputation.

Trials registration

NCT03216577.
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12.

Purpose

We evaluated whether 18F-FDG-PET altered stage classification, management, and prognostic stratification of newly diagnosed small cell lung cancer (SCLC).

Procedures

We identified 46 consecutive patients undergoing staging positron emission tomography for SCLC from 1993–2008 inclusive. Updated survival data from the state Cancer Registry was available on 42 of 46 patients.

Results

PET altered stage classification in 12 of 46 (26%) patients. PET altered treatment modality in nine patients, and the target mediastinal radiation field in another three patients. Therefore, PET altered management in 12 of 46 (26%) patients. Patients with limited disease (LD) on pre-PET staging had significantly longer overall survival (OS) than those upstaged to extensive disease (ED; median 18.6 months versus 5.7 months; log-rank p?versus 5.9 months; log-rank p?=?0.037).

Conclusion

PET had a major impact on stage classification, management, and prognostic stratification of newly diagnosed SCLC.
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13.

Purpose

The goal of this study was to develop a plasmid-based lux bio-reporter for use to obtain in vivo images of Brucella suis vaccine strain 2 (B.suis S2) infection with high resolution and good definition.

Procedures

The pBBR-lux (pBBR1MCS-2-lxCDABE) plasmid that carries the luxCDABE operon was introduced into B. suis S2 by electroporation yielding B. suis S2-lux. The spatial and temporal transit of B. suis S2 in mice and guinea pigs was monitored by bioluminescence imaging.

Results

The plasmid pBBR-lux is stable in vivo and does not appear to impact the virulence or growth of bacteria. This sensitive luciferase reporter could represent B. suis S2 survival in real time. B. suis S2 mainly colonized the lungs, liver, spleen, and uterus in mice and guinea pigs as demonstrated by bioluminescence imaging.

Conclusion

The plasmid-based lux bioreporter strategy can be used to obtain high resolution in vivo images of B. suis S2 infection in mice and guinea pigs.
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14.

Objectives

Assess differences in three-dimensional colonic metrics on CTC in women with or without hysterectomy following incomplete endoscopy to determine if there is a correlation between colonic morphology and incomplete colonoscopy after hysterectomy.

Methods

Quantitative rectosigmoid metrics were derived from CTC datasets of 37 women with hysterectomy and 36 women without hysterectomy who underwent CTC for incomplete endoscopy. Evaluated metrics included colonic length, volume, tortuosity, and compactness and sigmoid apex height relative to the lumbosacral junction. Differences were measured using the Student’s t test, and intra-reader reliability was assessed using ICC. The relative risk of incomplete rectosigmoid visualization was determined by reviewing the endoscopy reports.

Results

Women with hysterectomy had a lower sigmoid apex height (p = 0.002), as well as increased tortuosity (p = 0.012) and compactness (p = 0.001) and decreased length (p = 0.026) and volume (p = 0.016) of the rectosigmoid. Intra-reader reliability was high for centerline length (ICC = 0.9940) and sigmoid apex height (ICC = 0.9851). The relative risk of incomplete visualization of the rectosigmoid on endoscopy in women with hysterectomy was 2.068 (p = 0.043) compared to women without hysterectomy.

Conclusion

Our pilot data show reproducible quantitative differences in three-dimensional metrics of the rectosigmoid in women with or without hysterectomy who underwent CTC for incomplete endoscopy and increased relative risk of incomplete endoscopic visualization of the rectosigmoid after hysterectomy. Our findings suggest that women with hysterectomy may benefit from CTC rather than endoscopy as the initial diagnostic test for evaluating the colon.
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15.

Background

Up-to-date research on musculoskeletal- and neuromotor fitness (MSMF) is lacking. The aims of the present paper were to a) establish normative values of MSMF by gender and age, and b) to assess how much of the variance in MSMF can be explained by obesity in adults.

Methods

A random selection of 726 Norwegians (20–65 years) participated in a national cross-sectional study. Muscular endurance, muscular strength, explosive power, flexibility and balance were assessed in addition to waist circumference (WC).

Results

Females displayed significantly higher scores compared to males on muscular endurance of the back extensors and on the flexibility tests (p?<?0.001). Males displayed significantly higher scores than females (p?<?0.001) on handgrip strength, modified push-ups, and explosive power. An inverse association was found between age and all MSMF scores for females (Beta:?0.06–(?0.92), p?≤?0.044) and males (Beta:?0.15–(0.91), p?≤?0.006), where younger participants displayed higher test scores on all MSMF tests, compared to older participants. Furthermore, participants showing higher scores on WC displayed lower scores on the following MSMF tests for both females and males: muscular endurance of the back extensors, balance, flexibility of the shoulder, and explosive power (p?<?0.001). Additionally, male participants with higher WC scores showed lower scores on muscular endurance of the upper body and flexibility of the hamstrings compared to males with lower WC scores (p?<?0.001).

Conclusions

The data provide normative values of MSMF for adults based on age and gender, and support an inverse relationship of MSMF to age and WC.
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16.

Background

Impaired left atrial (LA) function is an early marker of cardiac dysfunction and predictor of adverse cardiac events. Herein, we assess LA structure and function in hypertrophy in hypertrophic cardiomyopathy (HCM) sarcomere mutation carriers with and without left ventricular hypertrophy (LVH).

Method

Seventy-three participants of the HCMNet study who underwent cardiovascular magnetic resonance (CMR) imaging were studied, including mutation carriers with overt HCM (n =?34), preclinical mutation carriers without HCM (n =?24) and healthy, familial controls (n =?15).

Results

LA volumes were similar between preclinical, control and overt HCM cohorts after covariate adjustment. However, there was evidence of impaired LA function with decreased LA total emptying function in both preclinical (64?±?8%) and overt HCM (59?±?10%), compared with controls (70?±?7%; p =?0.002 and p =?0.005, respectively). LA passive emptying function was also decreased in overt HCM (35?±?11%) compared with controls (47?±?10%; p =?0.006). Both LAtotal emptying function and LA passive emptying function were inversely correlated with the extent of late gadolinium enhancement (LGE; p?=?0.005 and p <?0.05, respectively), LV mass (p =?0.02 and p <?0.001) and interventricular septal thickness (p?<?0.001 for both) and serum NT-proBNP levels (p?<?0.001 for both).

Conclusion

LA dysfunction is detectable by CMR in preclinical HCM mutation carriers despite non-distinguishable LV wall thickness and LA volume. LA function appears most impaired in subjects with overt HCM and a greater extent of LV fibrosis.
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17.

Purpose

The purpose of the study is to investigate screening in follow-up care to identify head and neck cancer (HNC) patients with untreated psychological distress.

Methods

From November 2009 until December 2012, we investigated the use of OncoQuest (a touch screen computer system to monitor psychological distress (Hospital Anxiety and Depression Scale (HADS)) and quality of life (HRQOL; EORTC QLQ-C30 and H&N35 module) in routine follow-up care. Patients who screened positive for psychological distress (HADS-T >14, HADS-A >7, or HADS-D >7) were asked whether they received psychological or psychiatric treatment.

Results

During the study period of 37 months, OncoQuest was used by 720 individual HNC patients, of whom 714 had complete HADS data. Psychological distress was present in 206 patients (29 %). Of those patients who fulfilled in- and exclusion criteria (n?=?137), 25 received psychological treatment (18 %). Receipt of psychological treatment was significantly related to a higher score on the HADS total scale (19.6 vs. 16.9; p?=?0.019), a lower (worse) score on the EORTC QLQ-C30 scale emotional functioning (46.0 vs. 58.6; p?=?0.023), a higher (worse) score on fatigue (58.2 vs. 46.4; p?=?0.032), problems with sexuality (44.1 vs. 34.4; p?=?0.043), oral pain (43.8 vs. 28.8; p?=?0.011) and speech problems (37.0 vs. 25.3; p?=?0.042).

Conclusions

Screening for psychological distress via OncoQuest is beneficial because 82 % of HNC patients identified with an increased level of distress who do not yet receive mental treatment were identified. Patients who did receive treatment reported more distress and worse quality of life, which may be explained because patients with more severe problems maybe more inclined to seek help or might be detected easier by caregivers and referred to supportive care more often.
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18.

Background

Advances such as targeted muscle reinnervation and pattern recognition control may provide improved control of upper limb myoelectric prostheses, but evaluating user function remains challenging. Virtual environments are cost-effective and immersive tools that are increasingly used to provide practice and evaluate prosthesis control, but the relationship between virtual and physical outcomes—i.e., whether practice in a virtual environment translates to improved physical performance—is not understood.

Methods

Nine people with transhumeral amputations who previously had targeted muscle reinnervation surgery were fitted with a myoelectric prosthesis comprising a commercially available elbow, wrist, terminal device, and pattern recognition control system. Virtual and physical outcome measures were obtained before and after a 6-week home trial of the prosthesis.

Results

After the home trial, subjects showed statistically significant improvements (p <?0.05) in offline classification error, the virtual Target Achievement Control test, and the physical Southampton Hand Assessment Procedure and Box and Blocks Test. A trend toward improvement was also observed in the physical Clothespin Relocation task and Jebsen-Taylor test; however, these changes were not statistically significant. The median completion time in the virtual test correlated strongly and significantly with the Southampton Hand Assessment Procedure (p =?0.05, R =???0.86), Box and Blocks Test (p =?0.007, R =???0.82), Jebsen-Taylor Test (p =?0.003, R =?0.87), and the Assessment of Capacity for Myoelectric Control (p =?0.005,R =???0.85). The classification error performance only had a significant correlation with the Clothespin Relocation Test (p =?0.018, R =?.76).

Conclusions

In-home practice with a pattern recognition-controlled prosthesis improves functional control, as measured by both virtual and physical outcome measures. However, virtual measures need to be validated and standardized to ensure reliability in a clinical or research setting.

Trial registration

This is a registered clinical trial: NCT03097978.
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19.

Introduction

Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

Methods

In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC0–168h)].

Results

Steady-state exposure of semaglutide was similar for both populations: AUC0–168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (Cmax) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02. Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC0–168h ERR 1.11; Cmax ERR 1.14). Dose-dependent increases in AUC0–168h and Cmax occurred in both populations. Accumulation was as expected, based on the half-life (t1/2, ~ 1 week) and dosing interval of semaglutide. Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo. No new safety issues were identified.

Conclusions

The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects.

Funding

Novo Nordisk A/S, Denmark.

Trial registration

ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.
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20.

Background

Phytochemicals are natural bioactive compounds that protect plants against the stress. These phytochemicals may also have other biological activities like, antibacterial activity.

Objective

The objective of this work is to study the antibacterial effect of aqueous and hydro-alcoholic extracts prepared from Thymus vulgaris, Aloysia triphylla, Pistacia lentiscus, Olea europaea leaves and Trigonella foenum-graecum seeds on some pathogenic bacteria responsible for gastroenteritis.

Result

The results obtained from the antibacterial effect showed a moderate activity against the strains studied with a diameters of inhibition zones ranging from 07.00 ± 0.8 to 16.00 ± 1.0 mm for aqueous extracts and vary between 07.00 ± 0.9 and 13.00 ± 1.0 mm for hydro-alcoholic extracts.

Conclusion

This study confirms the possibility of using these plants or components in the prevention of several diseases like, gastroenteritis.
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