METHODS: In this retrospective study, we reviewed the cases diagnosed with CVST admitted to our centre from January 2011 until November 2015.
RESULTS: A total of 15 patients were included in this review. The patterns of imaging findings as well as risk factors for CVST is discussed with a review of the literature and current management practices. One year followed-up showed full recovery (Glasgow Outcome Scale (GOS) of 5) in 10 cases (66.7%), whereas 4 cases (26.7%) with GOS of 4 (three cases with neurological deficits, and 1 case with mild symptom. There was one case of mortality in this study secondary to sepsis during hospitalisation. The presenting symptoms were mainly headache, focal neurology deficits, seizure and altered sensorium. Risk factors identified were oral contraceptive pills usage, chronic sinuses or ear infections, and obesity. Initial computed tomography (CT) scan showed various findings and haemorrhagic infarct was one of the common findings. Magnetic resonance imaging (MRI) and magnetic resonance venography (MRV) revealed majority of the patients had occlusion at two or more venous sinus sites. No patients had new or recurrent intracranial haemorrhage following initiation of anticoagulation therapy.
CONCLUSION: Thus it is considerable safe to start anticoagulation therapy in CVST patients including those with intracranial haemorrhage. We propose further neuroimaging to avoid missed diagnosis of CVST in patient presented with recent onset headache and CT evidence of unusual cerebral infarction.
METHODS: Sixteen patients who were diagnosed with POR scheduled to undergo their second cycle of Intracytoplasmic sperm injection (ICSI)/embryo transfer cycle were enrolled. All enrolled patients had earlier undergone their first ICSI/embryo transfer cycle at least four months prior to this study. All subjects were given DHEA supplementation of 25mg three times daily for at least three months prior to their second ICSI/embryo transfer cycle. Statistical analysis of various ovarian response and ICSI outcomes parameter were compared pre and post DHEA.
RESULTS: Sixteen women with the mean age of 35 years were enrolled in the study. The comparative analysis of results showed a significant increase in the number of good quality of embryos obtained (p<0.05). After the treatment with DHEA, there was an improvement in the number of oocytes retrieved, Metaphase II (MII) oocyte (mature) oocytes obtained, fertilised and transferrable embryos and the pregnancy rate. There was no significant effect of DHEA treatment on the number of days of stimulation and cumulative dose of gonadotrophins used.
CONCLUSION: Our results is able to show that DHEA supplementation may help to enhance IVF-ICSI outcomes in women with POR especially in those age 35 years and below.
METHODS: A retrospective study was conducted on 20 patients who had suffered from ISSHL from January 1, 2012, to December 31, 2017. ISSHL is defined as a rapid decline in hearing over three days or less affecting three or more frequencies by 30dB or greater. Comparison between the mode of steroid therapies and improvement in patients was done. At least 15dB improvement in pure tone audiogram (PTA) was considered as successful therapeutic intervention.
RESULTS: Twenty male and female patients who fit the inclusion and exclusion criteria were included. The mean age of the patients was 41.4 years with a range from 13 to 72 years. Ninety percent patients presented with unilateral ISSHL involvement. Eight ears of patients who received systemic steroid therapy alone had improved hearings (75%). Out of seven ears from six patients who received salvage therapy, four ears (57.1 %) had improvement in PTA. Seven ears showed improvement in PTA from a total of eight patients who primarily received IT injections.
CONCLUSIONS: IT steroid therapy promises a favourable outcome in the improvement of the hearing, as compared to systemic steroid administration. Its usage is recommended not only for salvage therapy but should be used as primary treatment especially in those with co- morbidities.
METHODS: This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs).
RESULTS: Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean [LSM] difference vs placebo: -5.6 with blonanserin 40 mg; 95% confidence interval [CI] -9.6, -1.6; adjusted p = 0.007, and - 10.4 with blonanserin 80 mg; 95% CI -14.4, -6.4; adjusted p
MATERIAL AND METHODS: A validated database was used to generate data related to countries with declared lockdown. Simple regression analysis was conducted to assess the rate of change in infection and death rates. Subsequently, a k-means and hierarchical cluster analysis was done to identify the countries that performed similarly. Sweden and South Korea were included as counties without lockdown in a second-phase cluster analysis.
RESULTS: There was a significant 61% and 43% reduction in infection rates 1-week post lockdown in the overall and India cohorts, respectively, supporting its effectiveness. Countries with higher baseline infections and deaths (Spain, Germany, Italy, UK, and France-cluster 1) fared poorly compared to those who declared lockdown early on (Belgium, Austria, New Zealand, India, Hungary, Poland and Malaysia-cluster 2). Sweden and South Korea, countries without lock-down, fared as good as the countries in cluster 2.
CONCLUSION: Lockdown has proven to be an effective strategy is slowing down the SARS-CoV-2 disease progression (infection rate and death) exponentially. The success story of non-lock-down countries (Sweden and South Korea) need to be explored in detail, to identify the variables responsible for the positive results.
OBJECTIVES: To evaluate the efficacy and safety of animal-assisted therapy for people with dementia.
SEARCH METHODS: We searched ALOIS: the Cochrane Dementia and Cognitive Improvement Group's Specialised Register on 5 September 2019. ALOIS contains records of clinical trials identified from monthly searches of major healthcare databases, trial registries, and grey literature sources. We also searched MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), ISI Web of Science, ClinicalTrials.gov, and the WHO's trial registry portal.
SELECTION CRITERIA: We included randomised controlled trials (RCTs), cluster-randomised trials, and randomised cross-over trials that compared AAT versus no AAT, AAT using live animals versus alternatives such as robots or toys, or AAT versus any other active intervention.
DATA COLLECTION AND ANALYSIS: We extracted data using the standard methods of Cochrane Dementia. Two review authors independently assessed the eligibility and risk of bias of the retrieved records. We expressed our results using mean difference (MD), standardised mean difference (SMD), and risk ratio (RR) with their 95% confidence intervals (CIs) where appropriate.
MAIN RESULTS: We included nine RCTs from 10 reports. All nine studies were conducted in Europe and the US. Six studies were parallel-group, individually randomised RCTs; one was a randomised cross-over trial; and two were cluster-RCTs that were possibly related where randomisation took place at the level of the day care and nursing home. We identified two ongoing trials from trial registries. There were three comparisons: AAT versus no AAT (standard care or various non-animal-related activities), AAT using live animals versus robotic animals, and AAT using live animals versus the use of a soft animal toy. The studies evaluated 305 participants with dementia. One study used horses and the remainder used dogs as the therapy animal. The duration of the intervention ranged from six weeks to six months, and the therapy sessions lasted between 10 and 90 minutes each, with a frequency ranging from one session every two weeks to two sessions per week. There was a wide variety of instruments used to measure the outcomes. All studies were at high risk of performance bias and unclear risk of selection bias. Our certainty about the results for all major outcomes was very low to moderate. Comparing AAT versus no AAT, participants who received AAT may be slightly less depressed after the intervention (MD -2.87, 95% CI -5.24 to -0.50; 2 studies, 83 participants; low-certainty evidence), but they did not appear to have improved quality of life (MD 0.45, 95% CI -1.28 to 2.18; 3 studies, 164 participants; moderate-certainty evidence). There were no clear differences in all other major outcomes, including social functioning (MD -0.40, 95% CI -3.41 to 2.61; 1 study, 58 participants; low-certainty evidence), problematic behaviour (SMD -0.34, 95% CI -0.98 to 0.30; 3 studies, 142 participants; very-low-certainty evidence), agitation (SMD -0.39, 95% CI -0.89 to 0.10; 3 studies, 143 participants; very-low-certainty evidence), activities of daily living (MD 4.65, 95% CI -16.05 to 25.35; 1 study, 37 participants; low-certainty evidence), and self-care ability (MD 2.20, 95% CI -1.23 to 5.63; 1 study, 58 participants; low-certainty evidence). There were no data on adverse events. Comparing AAT using live animals versus robotic animals, one study (68 participants) found mixed effects on social function, with longer duration of physical contact but shorter duration of talking in participants who received AAT using live animals versus robotic animals (median: 93 seconds with live versus 28 seconds with robotic for physical contact; 164 seconds with live versus 206 seconds with robotic for talk directed at a person; 263 seconds with live versus 307 seconds with robotic for talk in total). Another study showed no clear differences between groups in behaviour measured using the Neuropsychiatric Inventory (MD -6.96, 95% CI -14.58 to 0.66; 78 participants; low-certainty evidence) or quality of life (MD -2.42, 95% CI -5.71 to 0.87; 78 participants; low-certainty evidence). There were no data on the other outcomes. Comparing AAT using live animals versus a soft toy cat, one study (64 participants) evaluated only social functioning, in the form of duration of contact and talking. The data were expressed as median and interquartile ranges. Duration of contact was slightly longer in participants in the AAT group and duration of talking slightly longer in those exposed to the toy cat. This was low-certainty evidence.
AUTHORS' CONCLUSIONS: We found low-certainty evidence that AAT may slightly reduce depressive symptoms in people with dementia. We found no clear evidence that AAT affects other outcomes in this population, with our certainty in the evidence ranging from very-low to moderate depending on the outcome. We found no evidence on safety or effects on the animals. Therefore, clear conclusions cannot yet be drawn about the overall benefits and risks of AAT in people with dementia. Further well-conducted RCTs are needed to improve the certainty of the evidence. In view of the difficulty in achieving blinding of participants and personnel in such trials, future RCTs should work on blinding outcome assessors, document allocation methods clearly, and include major patient-important outcomes such as affect, emotional and social functioning, quality of life, adverse events, and outcomes for animals.
METHODS AND ANALYSIS: The Global Outcome Assessment Life-long after stroke in young adults (GOAL) initiative aims to perform a global individual patient data meta-analysis with existing data from young stroke cohorts worldwide. All patients aged 18-50 years with ischaemic stroke or intracerebral haemorrhage will be included. Outcomes will be the distribution of stroke aetiology and (vascular) risk factors, functional outcome after stroke, risk of recurrent vascular events and death and finally the use of secondary prevention. Subgroup analyses will be made based on age, gender, aetiology, ethnicity and climate of residence.
ETHICS AND DISSEMINATION: Ethical approval for the GOAL study has already been obtained from the Medical Review Ethics Committee region Arnhem-Nijmegen. Additionally and when necessary, approval will also be obtained from national or local institutional review boards in the participating centres. When needed, a standardised data transfer agreement will be provided for participating centres. We plan dissemination of our results in peer-reviewed international scientific journals and through conference presentations. We expect that the results of this unique study will lead to better understanding of worldwide differences in risk factors, causes and outcome of young stroke patients.
DESIGN: Cross-sectional study.
SETTING: Primary and secondary schools in Malaysia.
PARTICIPANTS: 11 246 non-smoking school-going adolescents.
OUTCOME MEASURES: The prevalence and factors associated with smoking susceptibility among non-smoking school-going adolescents in Malaysia.
RESULTS: Approximately 14% of non-smokers were susceptible to smoking, and the prevalence of susceptibility was significantly higher among males, ever-smokers and e-cigarette users. The odds of susceptibility to smoking were higher among males, e-cigarette users, those aged 12 years and under and those who had ever smoked or tried cigarettes. Students from schools with educational programmes on the health effects of second-hand smoke (SHS) and who perceived smoking to be harmful were less likely to be susceptible to smoking.
CONCLUSION: Smoking susceptibility is prevalent among school-going adolescents. A comprehensive approach that enhances or reinforces health education programmes on the adverse health effects of smoking and SHS among school children, that considers multiple factors and that involves all stakeholders is urgently needed to reduce the prevalence of smoking susceptibility among vulnerable subgroups, as identified from the present findings.
METHODS: This is an assessor-blinded quasi-experimental study comparing two approaches of physiotherapy, namely pulsed ultrasound-added physiotherapy and conventional physiotherapy. Total number of participants with TKA required for this study will be calculated based on the result of a pilot study. Participants will be alternately allocated into either pulsed ultrasound-added physiotherapy group (low-intensity pulsed ultrasound and conventional physiotherapy) or control group (conventional physiotherapy). Pulsed ultrasound-added physiotherapy group will receive low-intensity pulsed ultrasound starting at post-operative day 2 (4-5 times for the first-week after surgery and 2-3 times a week for a further 2 weeks). Both groups will receive conventional physiotherapy 4 to 5 times for the first-week after surgery and 2 to 3 times a week for a further 11 weeks. This procedure and process will be tested and established in a pilot study. Primary outcomes of interest are pain level, swelling, active range of knee motion, and quadriceps strength. The secondary outcomes are functional performance and quality of life.
DISCUSSION: This study will fill the gaps in knowledge relating the benefits of including low-intensity pulsed ultrasound into conventional physiotherapy for patients with TKA.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12618001226291.
Objective: To investigate the acceptability and pharmacokinetics (PK) of SC injection of TU.
Design: Randomized sequence, crossover clinical study of SC vs IM TU injections.
Setting: Ambulatory clinic of an academic andrology center.
Participants: Twenty men (11 hypogonadal, 9 transgender men) who were long-term users of TU. injections. Intervention: Injection of 1000 mg TU (in 4 mL castor oil vehicle) by SC or IM route. Main Outcome Measures: Patient-reported pain, acceptability, and preference scales. PK by measurement of serum testosterone, dihydrotestosterone (DHT), and estradiol (E2) concentrations with application of population PK methods and dried blood spot (DBS) sampling.
Results: Pain was greater after SC compared with IM injection 24 hours (but not immediately) after injection but both routes were equally acceptable. Ultimately 11 preferred IM, 6 preferred SC, and 3 had no preference. The DBS-based PK analysis of serum testosterone revealed a later time of peak testosterone concentration after SC vs IM injection (8.0 vs 3.3 days) but no significant route differences in model-predicted peak testosterone concentration (8.4 vs 9.6 ng/mL) or mean resident time (183 vs 110 days). The PK of venous serum testosterone, DHT, and E2 did not differ according to route of injection.
Conclusions: We conclude that SC TU injection is acceptable but produces greater pain 24 hours after injection that may contribute to the overall majority preference for the IM injection. The PK of testosterone, DHT, or E2 did not differ substantially between SC and IM routes. Hence whereas further studies are required, the SC route represents an alternative to IM injections without a need to change dose for men for whom IM injection is not desired or recommended.
Purpose: To investigate the effects of 'graded exercise integrated with education' on physical fitness, exercise self-efficacy (ESE), and physical activity (PA) levels among subacute and chronic wheelchair-dependent paraplegia patients.
Overview of Literature: Most of the chronic spinal cord injury (SCI) patients had low physical fitness due to a sedentary lifestyle and lack of ESE after discharge from a rehabilitation program. Education may encourage them to engage with exercise to regain and maintain their physical fitness. However, there is a lack of research to support the effects of exercise integrated with education after an SCI.
Methods: A total of 44 participants will be assigned to either the experimental group (graded exercise integrated with education) or active control (conventional physical therapy). The experimental group will receive graded strength and aerobic exercise training according to their progression criteria. They will attend an education program during and after the rehabilitation program. The control group will only receive conventional physical therapy during their in-rehabilitation program. This study will be conducted during a period of 16 weeks, consisting of 8 weeks of in-rehabilitation and 8 weeks post-rehabilitation. Statistical analysis will be performed using the IBM SPSS ver. 21.0 (IBM Corp., Armonk, NY, USA) at a significance level of p≤0.05.
Results: The primary outcome measures will be upper-limb isokinetic strength, isometric grip strength, and cardiorespiratory fitness. The secondary outcomes will be ESE and PA levels.
Conclusions: An intervention that combines exercise training and education may be warranted to enhance the physical fitness, ESE, and PA levels in SCI patients. This trial was registered with ClinicalTrials.gov (NCT03420170).
AIM: The aim of this study was to classify the primary outcomes used in Cochrane Systematic Reviews (CSRs) into the ICF domains of functioning; to describe the differences in primary outcomes in reviews related to rehabilitation intervention and non-rehabilitation intervention; and to describe the trend of outcome selections according year of publication.
DESIGN: Methodological paper.
POPULATION: Adult stroke population.
METHODS: We analyzed the primary outcomes used in the CSRs published by the Cochrane Stroke Review Group up to December 2017. The primary outcomes were extracted and classified into the ICF domains of functioning (body functions, body structures and activity and participation).
RESULTS: One hundred and seventy-four papers with 216 primary outcomes were included in this analysis. Less than half (102/216, 47.2%) of the outcomes could be classified into the ICF domains of functioning. For the outcomes that could be classified into the ICF domains, the majority (72/102, 70.5%) were in the activity and participation domain, followed by body functions (26/102, 25.5%) and body structures (4/102, 4.0%). Of the outcomes that could not be classified into the ICF domains (N.=114), death (81/114, 71.1%) and recurrent stroke (21/114,18.4%) formed the majority of the outcome. There were 75 CSRs on rehabilitation related interventions; the majority of the outcomes (75/97, 77.3%) used in rehabilitation related CSRs could be classified into the ICF framework with more than half (49/75, 65.3%) in the activity and participation domain.
CONCLUSIONS: The majority of the primary outcomes selected by the Cochrane Stroke Review Group in their CSRs could not be classified into the ICF domains of functioning. Death and recurrence of vascular events remains the major outcome of interest. In rehabilitation related interventions, activity and participation domain is the functioning domain most commonly used.
CLINICAL REHABILITATION IMPACT: The systematic use of patients-centered ICF-based outcomes in CSRs could help the application of evidence in clinical decision making.