33 research outputs found

    Prospective Home-use Study on Non-invasive Neuromodulation Therapy for Essential Tremor.

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    Highlights: This prospective study is one of the largest clinical trials in essential tremor to date. Study findings suggest that individualized non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction and improves quality of life for many essential tremor patients. Background: Two previous randomized, controlled, single-session trials demonstrated efficacy of non-invasive neuromodulation therapy targeting the median and radial nerves for reducing hand tremor. This current study evaluated efficacy and safety of the therapy over three months of repeated home use. Methods: This was a prospective, open-label, post-clearance, single-arm study with 263 patients enrolled across 26 sites. Patients were instructed to use the therapy twice daily for three months. Pre-specified co-primary endpoints were improvements on clinician-rated Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) and patient-rated Bain & Findley Activities of Daily Living (BF-ADL) dominant hand scores. Other endpoints included improvement in the tremor power detected by an accelerometer on the therapeutic device, Clinical and Patient Global Impression scores (CGI-I, PGI-I), and Quality of Life in Essential Tremor (QUEST) survey. Results: 205 patients completed the study. The co-primary endpoints were met (p≪0.0001), with 62% (TETRAS) and 68% (BF-ADL) of \u27severe\u27 or \u27moderate\u27 patients improving to \u27mild\u27 or \u27slight\u27. Clinicians (CGI-I) reported improvement in 68% of patients, 60% (PGI-I) of patients reported improvement, and QUEST improved (p = 0.0019). Wrist-worn accelerometer recordings before and after 21,806 therapy sessions showed that 92% of patients improved, and 54% of patients experienced ≥50% improvement in tremor power. Device-related adverse events (e.g., wrist discomfort, skin irritation, pain) occurred in 18% of patients. No device-related serious adverse events were reported. Discussion: This study suggests that non-invasive neuromodulation therapy used repeatedly at home over three months results in safe and effective hand tremor reduction in many essential tremor patients

    The state of the Martian climate

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    60°N was +2.0°C, relative to the 1981–2010 average value (Fig. 5.1). This marks a new high for the record. The average annual surface air temperature (SAT) anomaly for 2016 for land stations north of starting in 1900, and is a significant increase over the previous highest value of +1.2°C, which was observed in 2007, 2011, and 2015. Average global annual temperatures also showed record values in 2015 and 2016. Currently, the Arctic is warming at more than twice the rate of lower latitudes

    Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

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    BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years

    Qualitative Clinical Evaluation of Scapular Dysfunction: A Reliability Study

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    The purpose of this study was to determine the intrarater and interrater reliability of a clinical evaluation system for scapular dysfunction. No commonly accepted terminology presently exists for describing the abnormal dynamic scapular movement patterns that are commonly associated with shoulder injury. A method of observation was devised for clinical evaluation of scapular dysfunction. Blinded evaluators (2 physicians and 2 physical therapists) were familiarized with the evaluation method of scapular movement patterns before viewing a videotape of 26 subjects with and without scapular dysfunction. Each evaluator was asked to categorize the predominant scapular movement pattern observed during bilateral humeral scaption and abduction motions. Reliability was assessed by a κ coefficient. Intertester reliability (κ = 0.4) was found to be slightly lower than intratester reliability (κ = 0.5). These results indicate that, with refinement, this qualitative evaluation method may allow clinicians to standardize the categorization of dynamic scapular dysfunction patterns

    Assessing the Prevalence of and Risk Factors for Disordered Eating Attitudes and Behaviors in Adolescents With Inflammatory Bowel Disease

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    Adolescents living with inflammatory bowel disease (IBD) have a higher incidence of internalizing disorders, lower quality of life, and impaired social functioning relative to healthy peers.1 Medical and psychosocial risk factors for eating pathology and body image concerns also affect youth with IBD, including medical hyperfocus on weight, medically related food restriction, body image uncertainty, and societal praise of thinness despite health issues.2 Treatment-related risk factors may increase vulnerability to eating pathology and poor body image, including adverse effects of steroids and psychosocial sequelae related to surgery/medical devices (eg, body dissatisfaction after surgery). Adults with IBD have reported high rates of body image dissatisfaction (BID)3; however, few studies have examined prevalence rates among adolescents with IBD. In a review of BID and disordered eating behaviors in pediatric chronic illnesses, 53% and 16% of patients with cystic fibrosis were found to have disordered eating attitudes and disordered eating behaviors, respectively, and patients with type 1 diabetes were more than twice as likely as healthy peers to engage in disordered eating behaviors.2 A recent study of BID in newly diagnosed pediatric IBD found that older age, worse patient-reported disease status, and greater depressive symptoms were associated with higher levels of BID.4 The understanding of BID concerns in pediatric IBD beyond initial diagnosis is unknown and remains essential to care planning for medications and surgery. In addition to BID, young people with IBD may be at risk for disordered eating behaviors, though there is little known about this prevalence. Adolescents with IBD who experience BID and disordered eating are vulnerable for poor outcomes given their need to maintain healthy nutritional status for growth and disease management. The current study assessed the prevalence of disordered eating attitudes and behaviors in adolescents with IBD and factors associated with disordered eating. Determining the prevalence in adolescents with IBD may help clinicians understand the extent of this problem. Discerning the contributions of the unique psychosocial and medical risk factors to this population may provide a framework for developing screening measures and interventions

    Assessing the Prevalence of and Risk Factors for Disordered Eating Attitudes and Behaviors in Adolescents With Inflammatory Bowel Disease

    No full text
    Adolescents living with inflammatory bowel disease (IBD) have a higher incidence of internalizing disorders, lower quality of life, and impaired social functioning relative to healthy peers.1 Medical and psychosocial risk factors for eating pathology and body image concerns also affect youth with IBD, including medical hyperfocus on weight, medically related food restriction, body image uncertainty, and societal praise of thinness despite health issues.2 Treatment-related risk factors may increase vulnerability to eating pathology and poor body image, including adverse effects of steroids and psychosocial sequelae related to surgery/medical devices (eg, body dissatisfaction after surgery). Adults with IBD have reported high rates of body image dissatisfaction (BID)3; however, few studies have examined prevalence rates among adolescents with IBD. In a review of BID and disordered eating behaviors in pediatric chronic illnesses, 53% and 16% of patients with cystic fibrosis were found to have disordered eating attitudes and disordered eating behaviors, respectively, and patients with type 1 diabetes were more than twice as likely as healthy peers to engage in disordered eating behaviors.2 A recent study of BID in newly diagnosed pediatric IBD found that older age, worse patient-reported disease status, and greater depressive symptoms were associated with higher levels of BID.4 The understanding of BID concerns in pediatric IBD beyond initial diagnosis is unknown and remains essential to care planning for medications and surgery. In addition to BID, young people with IBD may be at risk for disordered eating behaviors, though there is little known about this prevalence. Adolescents with IBD who experience BID and disordered eating are vulnerable for poor outcomes given their need to maintain healthy nutritional status for growth and disease management. The current study assessed the prevalence of disordered eating attitudes and behaviors in adolescents with IBD and factors associated with disordered eating. Determining the prevalence in adolescents with IBD may help clinicians understand the extent of this problem. Discerning the contributions of the unique psychosocial and medical risk factors to this population may provide a framework for developing screening measures and interventions
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