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Sample records for multicenter prospective 12-month

  1. Absorbable hydrogel spacer use in men undergoing prostate cancer radiotherapy: 12 month toxicity and proctoscopy results of a prospective multicenter phase II trial

    International Nuclear Information System (INIS)

    Uhl, Matthias; DeWeese, Theodore L; Herfarth, Klaus; Eble, Michael J; Pinkawa, Michael; Triest, Baukelien van; Kalisvaart, Robin; Weber, Damien C; Miralbell, Raymond; Song, Danny Y

    2014-01-01

    Radiation therapy is one of the recommended treatment options for localized prostate cancer. In randomized trials, dose escalation was correlated with better biochemical control but also with higher rectal toxicity. A prospective multicenter phase II study was carried out to evaluate the safety, clinical and dosimetric effects of the hydrogel prostate-rectum spacer. Here we present the 12 months toxicity results of this trial. Fifty two patients with localized prostate cancer received a transperineal PEG hydrogel injection between the prostate and rectum, and then received IMRT to a dose of 78 Gy. Gastrointestinal and genitourinary toxicity were recorded during treatment and at 3, 6 and 12 months following irradiation by using the RTOG/EORTC criteria. Additionally, proctoscopy was performed 12 months after treatment and the results were scored using the Vienna Rectoscopy Scale (VRS). Of the patients treated 39.6% and 12.5% experienced acute Grade 1 and Grade 2 GI toxicity, respectively. There was no Grade 3 or Grade 4 acute GI toxicity experienced in the study. Only 4.3% showed late Grade 1 GI toxicity, and there was no late Grade 2 or greater GI toxicity experienced in the study. A total of 41.7%, 35.4% and 2.1% of the men experienced acute Grade 1, Grade 2 and Grade 3 GU toxicity, respectively. There was no Grade 4 acute GU toxicity experienced in the study. Late Grade 1 and Grade 2 GU toxicity was experienced in 17.0% and 2.1% of the patients, respectively. There was no late Grade 3 or greater GU toxicity experienced in the study. Seventy one percent of the patients had a VRS score of 0, and one patient (2%) had Grade 3 teleangiectasia. There was no evidence of ulceration, stricture or necrosis at 12 months. The use of PEG spacer gel is a safe and effective method to spare the rectum from higher dose and toxicity

  2. Safety and effectiveness of minimally invasive sacroiliac joint fusion in women with persistent post-partum posterior pelvic girdle pain: 12-month outcomes from a prospective, multi-center trial.

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    Capobianco, Robyn; Cher, Daniel

    2015-01-01

    Postpartum posterior pelvic girdle pain (PPGP) affects nearly 20 % of women who experience back pain in the peripartum period. The sacroiliac joint is a source of this pain in 75 % of women with persistent PPGP. A subset of women will fail to obtain acceptable pain relief from the current array of non-surgical treatment options. The purpose of this study is to assess the safety and effectiveness of minimally invasive sacroiliac (SI) joint fusion in women with chronic SI joint dysfunction whose pain began in the peri-partum period whose symptoms were recalcitrant to non-surgical management. A sub-group analysis of subjects with sacroiliac joint disruption and/or degenerative sacroiliitis enrolled in a prospective, multi-center trial of SI joint fusion was performed. Subjects with PPGP were identified and compared with women without PPGP and with men. Of 172 enrolled subjects, 52 were male, 100 were females without PPGP and 20 females had PPGP. PPGP subjects were significantly younger (43.3 years, vs. 52.8 for females without PPGP and 50.5 for men, p = 0.002). There were no differences in any other demographic or baseline clinical measure. Women with PPGP experienced a significant improvement in pain (-51 mm on VAS), function (-20.6 pts on ODI) and quality of life (SF-36 PCS +10.4, MCS +7.2, EQ-5D +0.31) at 12 months after surgery. These improvements were characteristic of the overall study results; no difference was detected between sub-groups. The sacroiliac joint can be a source of pain in women with persistent PPGP and should be investigated as a pain generator. In this study, women with carefully diagnosed chronic SI joint pain from PPGP recalcitrant to conservative therapies experienced clinically beneficially improvements in pain, disability and quality of life after minimally invasive SI joint fusion using a series of triangular porous plasma spray coated implants.

  3. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study.

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    McKinsey, James F; Zeller, Thomas; Rocha-Singh, Krishna J; Jaff, Michael R; Garcia, Lawrence A

    2014-08-01

    The aim of this study was to assess the safety and effectiveness of directional atherectomy (DA) for endovascular treatment of peripheral arterial disease (PAD) in infrainguinal arteries in patients with claudication or critical limb ischemia. To date, no prospective, multicenter, independently-adjudicated study has evaluated the effectiveness and durability of DA in the treatment of PAD. Previous DA studies have not been prospectively powered to evaluate any differences in outcomes in patients with and without diabetes. DEFINITIVE LE (Determination of EFfectiveness of the SilverHawk(®) PerIpheral Plaque ExcisioN System (SIlverHawk Device) for the Treatment of Infrainguinal VEssels / Lower Extremities) prospectively enrolled subjects at 47 multinational centers with an infrainguinal lesion length up to 20 cm. Primary endpoints were defined as primary patency at 12 months for claudicants and freedom from major unplanned amputation for critical limb ischemia (CLI) subjects. A pre-specified statistical hypothesis evaluated noninferiority of primary patency in diabetic versus nondiabetic claudicants. Independent angiographic and sonographic core laboratories assessed outcomes, and events were adjudicated by a clinical events committee. A total of 800 subjects were enrolled. The 12-month primary patency was 78% (95% confidence interval: 74.0% to 80.6%) in claudicants, with a 77% rate in the diabetic subgroup versus 78% in the nondiabetic subgroup (noninferior, p < 0.001). The rate of freedom from major unplanned amputation of the target limb at 12 months in CLI subjects was 95% (95% confidence interval: 90.7% to 97.4%). Periprocedural adverse events included embolization (3.8%), perforation (5.3%), and abrupt closure (2.0%). The bail-out stent rate was 3.2%. The DEFINITIVE LE study demonstrated that DA is a safe and effective treatment modality at 12 months for a diverse patient population with either claudication or CLI. Furthermore, DA was shown to be noninferior for

  4. Quit and Smoking Reduction Rates in Vape Shop Consumers: A Prospective 12-Month Survey

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    Riccardo Polosa

    2015-03-01

    Full Text Available Aims: Here, we present results from a prospective pilot study that was aimed at surveying changes in daily cigarette consumption in smokers making their first purchase at vape shops. Modifications in products purchase were also noted. Design: Participants were instructed how to charge, fill, activate and use their e-cigarettes (e-cigs. Participants were encouraged to use these products in the anticipation of reducing the number of cig/day smoked. Settings: Staff from LIAF contacted 10 vape shops in the province of the city of Catania (Italy that acted as sponsors to the 2013 No Tobacco Day. Participants: 71 adult smokers (≥18 years old making their first purchase at local participating vape shops were asked by professional retail staff to complete a form. Measurements: Their cigarette consumption was followed-up prospectively at 6 and 12 months. Details of products purchase (i.e., e-cigs hardware, e-liquid nicotine strengths and flavours were also noted. Findings: Retention rate was elevated, with 69% of participants attending their final follow-up visit. At 12 month, 40.8% subjects could be classified as quitters, 25.4% as reducers and 33.8% as failures. Switching from standard refillables (initial choice to more advanced devices (MODs was observed in this study (from 8.5% at baseline to 18.4% at 12 month as well as a trend in decreasing thee-liquid nicotine strength, with more participants adopting low nicotine strength (from 49.3% at baseline to 57.1% at 12 month. Conclusions: We have found that smokers purchasing e-cigarettes from vape shops with professional advice and support can achieve high success rates.

  5. Predictors of self-rated health: a 12-month prospective study of IT and media workers.

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    Hasson, Dan; Arnetz, Bengt B; Theorell, Töres; Anderberg, Ulla Maria

    2006-07-31

    The aim of the present study was to determine health-related risk and salutogenic factors and to use these to construct prediction models for future self-rated health (SRH), i.e. find possible characteristics predicting individuals improving or worsening in SRH over time (0-12 months). A prospective study was conducted with measurements (physiological markers and self-ratings) at 0, 6 and 12 months, involving 303 employees (187 men and 116 women, age 23-64) from four information technology and two media companies. There were a multitude of statistically significant cross-sectional correlations (Spearman's Rho) between SRH and other self-ratings as well as physiological markers. Predictors of future SRH were baseline ratings of SRH, self-esteem and social support (logistic regression), and SRH, sleep quality and sense of coherence (linear regression). The results of the present study indicate that baseline SRH and other self-ratings are predictive of future SRH. It is cautiously implied that SRH, self-esteem, social support, sleep quality and sense of coherence might be predictors of future SRH and therefore possibly also of various future health outcomes.

  6. Predictors of self-rated health: a 12-month prospective study of IT and media workers

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    Arnetz Bengt B

    2006-07-01

    Full Text Available Abstract Objective The aim of the present study was to determine health-related risk and salutogenic factors and to use these to construct prediction models for future self-rated health (SRH, i.e. find possible characteristics predicting individuals improving or worsening in SRH over time (0–12 months. Methods A prospective study was conducted with measurements (physiological markers and self-ratings at 0, 6 and 12 months, involving 303 employees (187 men and 116 women, age 23–64 from four information technology and two media companies. Results There were a multitude of statistically significant cross-sectional correlations (Spearman's Rho between SRH and other self-ratings as well as physiological markers. Predictors of future SRH were baseline ratings of SRH, self-esteem and social support (logistic regression, and SRH, sleep quality and sense of coherence (linear regression. Conclusion The results of the present study indicate that baseline SRH and other self-ratings are predictive of future SRH. It is cautiously implied that SRH, self-esteem, social support, sleep quality and sense of coherence might be predictors of future SRH and therefore possibly also of various future health outcomes.

  7. Child and Adolescent Emergency and Urgent Mental Health Delivery Through Telepsychiatry: 12-Month Prospective Study.

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    Roberts, Nasreen; Hu, Tina; Axas, Nicholas; Repetti, Leanne

    2017-10-01

    The significant gap between children and adolescents presenting for emergency mental healthcare and the shortage of child and adolescent psychiatrists constitutes a major barrier to timely access for psychiatric assessment for rural and remote areas. Unlike remote areas, urban emergency departments have in-house psychiatric consultation. Telepsychiatry may be a solution to ensure the same service for remote areas. However, there is a paucity of studies on the use of telepsychiatry for child and adolescent emergency consults. Thus, the aim of our study was to (1) assess patient satisfaction with telepsychiatry and (2) compare clinical characteristics and outcome of telepsychiatry with face-to-face emergency child and adolescent assessments. This is a prospective study of telepsychiatry emergency assessments of children and adolescents referred by emergency physicians. The comparison group was age- and gender-matched patients seen for face-to-face urgent assessments. Data were gathered on demographic and clinical variables. Telepsychiatry satisfaction was assessed using a questionnaire. Descriptive statistics and chi-square tests were used to assess group differences for each variable. Logistic regression was used to assess impact of the variables on outcome after the consult. A p value <0.05 was used to determine statistical significance. Sixty (n = 60) assessments were conducted through telepsychiatry in 12 months. Among the telepsychiatry group, Aboriginal patients were over-represented (50% vs. 6.7%, p < 0.001), a higher proportion received a diagnosis of adjustment disorder (22% vs. 8.3%, p = 0.004) or no diagnosis (27% vs. 6.7%, p = 0.004) compared with controls. There was no statistically significant difference between groups on other clinical variables. Patients reported a high degree of satisfaction with telepsychiatry. Telepsychiatry is acceptable to patients and families for safe emergency assessment and follow-up, reducing unnecessary travel

  8. Weight loss after bariatric surgery and periodontal changes: a 12-month prospective study.

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    Sales-Peres, Silvia Helena de Carvalho; Sales-Peres, Matheus de Carvalho; Ceneviva, Reginaldo; Bernabé, Eduardo

    2017-04-01

    Several longitudinal studies have explored the association of obesity and weight gain with periodontal disease. However, the effect of weight loss on periodontal tissues remains unclear. To explore whether weight loss after bariatric surgery was associated with changes in periodontal measures over 12 months. Two public hospitals in São Paulo, Brazil. We used data from 110 morbidly obese patients (body mass index [BMI]>40 kg/m 2 or≥35 kg/m 2 with co-morbid conditions) who underwent bariatric surgery between April 2011 and March 2013. Data on demographic factors, BMI, smoking habits, and glucose levels were extracted from medical records preoperatively and after 6 and 12 months postsurgery. A full-mouth periodontal examination was conducted by trained examiners to assess probing pocket depth, clinical attachment loss, and bleeding on probing (BOP) at baseline and 6 and 12 months after surgery. Data were analyzed using linear mixed-effects models. BMI was not significantly related to the proportion of sites with BOP at baseline, but it was negatively associated with the rate of change in the proportion of sites with BOP. The greater the BMI loss, the higher the proportion of sites with BOP, particularly 6 months after surgery. However, BMI was not associated with baseline probing pocket depth and clinical attachment loss or rates of changes in these periodontal outcomes. The findings suggest that weight loss was associated with increased gingival bleeding, showing a peak at 6 months after bariatric surgery. Periodontal pocketing and attachment loss remained unchanged during the study period. Copyright © 2017. Published by Elsevier Inc.

  9. Disruptions in brain networks of older fallers are associated with subsequent cognitive decline: a 12-month prospective exploratory study.

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    Chun Liang Hsu

    Full Text Available Cognitive impairment and impaired mobility are major public health concerns. There is growing recognition that impaired mobility is an early biomarker of cognitive impairment and dementia. The neural basis for this association is currently unclear. We propose disrupted functional connectivity as a potential mechanism. In this 12-month prospective exploratory study, we compared functional connectivity of four brain networks- the default mode network (DMN, fronto-executive network (FEN, fronto-parietal network (FPN, and the primary motor sensory network (SMN--between community-dwelling older adults with ≥ two falls in the last 12 months and their non-falling counterparts (≤ one fall in the last 12 months. Functional connectivity was examined both at rest and during a simple motor tapping task. Compared with non-fallers, fallers showed more connectivity between the DMN and FPN during right finger tapping (p  = 0.04, and significantly less functional connectivity between the SMN and FPN during rest (p ≤ 0.05. Less connectivity between the SMN and FPN during rest was significantly associated with greater decline in both cognitive function and mobility over the12-month period (r =  -0.32 and 0.33 respectively; p ≤ 0.04. Thus, a recent history of multiple falls among older adults without a diagnosis of dementia may indicate sub-clinical changes in brain function and increased risk for subsequent decline.

  10. APPLICATION OF FILTEK SILORANE-INITIAL OBSERVATIONS AND PROSPECTIVE CLINICAL TRIAL FOR 12 MONTH

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    Lyubomir Vangelov

    2010-12-01

    Full Text Available Polymerization shrinkage and related adverse effects are still considered a major problem of dental composites. To solve this problem different approaches are offered. Currently, 3M ESPE developed a new monomer system based on cationic ring opening, the goal is to create a composite material with low polymerization shrinкage called siloran. Aim: To investigate the clinical presentation of Filtek д Silorane Low Shrink Posterior Restorative for an observation period of 12 months. Material and methods: The study included 36 patients. Total of 66 restorations are made. They were evaluated using modified USPHS criteria of Ryge and Cvar. After their assessment, restorations were captured with a digital camera and X-rays were taken in parallel technique. On control examination after one year, 31 patients (63 restorations were available for the study. Same parameters were assessed and new digital pictures and X-rays were made. The statistics was made with software SPSS version 17. For statistical analysis a Criterion Pirson (x2 was used. Results: With the exception of one of the criteria, it was shown that no statistically significant difference exists between the baseline and after one year (p> 0,05. Only the criterion surface of the filling was found to have statistically significant difference (p <0,05

  11. Visual Acuity Change over 12 Months in the Prospective Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Study: ProgStar Report Number 6.

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    Kong, Xiangrong; Strauss, Rupert W; Cideciyan, Artur V; Michaelides, Michel; Sahel, José-Alain; Munoz, Beatriz; Ahmed, Mohamed; Ervin, Ann M; West, Sheila K; Cheetham, Janet K; Scholl, Hendrik P N

    2017-11-01

    To estimate the yearly rate of change of best-corrected visual acuity (BCVA) and the risk of loss 1 line or more over 1 year and to identify risk factors for BCVA loss in patients with Stargardt disease (STGD1). Multicenter, prospective cohort study. Two hundred fifty-nine patients (489 eyes) with molecularly confirmed STGD1 enrolled at 9 centers in the United States and Europe. Participants were followed up every 6 months, and data at the baseline and 6- and 12-month visits were analyzed. Best-corrected visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Standardized reporting forms were used to collect participants' characteristics and clinical observations. Linear mixed effects models were used to estimate the rate of BCVA loss. Linear models with generalized estimating equations were used to identify risk factors for BCVA loss of 1 line or more over 1 year. Change in BCVA over 1 year. Cross-sectional analysis at baseline showed that earlier symptom onset and longer duration since onset was associated with worse BCVA. Longitudinal analysis showed no overall significant change of BCVA within 12 months, but the rate of BCVA change was significantly different by baseline BCVA (P trials with 1 year's duration. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  12. [Inadequate ICU-admissions : A 12-month prospective cohort study at a German University Hospital].

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    Bangert, K; Borch, J; Ferahli, S; Braune, S A; de Heer, G; Kluge, S

    2016-05-01

    Intensive care medicine (ICM) is increasingly utilized by a growing number of critically ill patients worldwide. The reasons for this are an increasingly ageing and multimorbid population and technological improvements in ICM. Inappropriate patient admissions to the intensive care unit (ICU) can be a threat to rational resource allocation and to patient autonomy. In this study, the incidence, characteristics, and resource utilization of patients inappropriately admitted to ICUs are studied. This prospective study included all consecutive patients admitted from 01 September 2012 to 31 August 2013 to the Department of Intensive Care Medicine of a German university hospital comprised of 10 ICUs and 120 beds. Inappropriate admission was defined according to category 4B of the recommendations of the Society of Critical Care Medicine (SCCM; "futility of ICU treatment" or "ICU declined by patient") and was determined in each suspected case by structured group discussions between the study team and all involved care givers including the referring team. In all, 66 of 6452 ICU admissions (1 %) were suspected to have been inappropriate on retrospective evaluation the day after admission. In 50 patients (0.8 %), an interdisciplinary consensus was reached on the inappropriateness of the ICU admission. Of these 50 patients, 41 (82 %) had previously declined ICU treatment in principle. This information was based on the patient's presumed wish as expressed by next of kin (56 %) or in a written advanced directive (26 %). In 9 patients (18 %), ICU treatment was considered futile. In all cases, a lack of information regarding a patient's wishes or clinical prognosis was the reason for inappropriate ICU admission. In this study, patients were regularly admitted to the ICU despite their contrary wish/directive or an unfavorable clinical condition. Although this was registered in only 1 % of all admissions, optimizing preICU admission information flow with regard to

  13. The progression of 102 Brazilian patients with bipolar disorder: outcome of first 12 months of prospective follow-up

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    Fernanda Novis

    2014-03-01

    Full Text Available INTRODUCTION: Prospective studies have shown that the course of bipolar disorder (BD is characterized by the persistence of symptoms, predominantly depression, along most of the time. However, to our knowledge, no studies in Latin America have investigated it. OBJECTIVES: To replicate international studies using a Brazilian sample to prospectively analyze treatment outcomes in the first year and to determine potential chronicity factors. METHODS: We followed up 102 patients with BD for 12 months and evaluated the number of months with affective episodes and the intensity of manic and depressive symptoms using the Young Mania Rating Scale (YMRS and the Hamilton Depression Scale (HAM-D17. Sociodemographic and retrospective clinical data were examined to determine possible predictors of outcome. RESULTS: Almost 50% of the patients had symptoms about half of the time, and there was a predominance of depressive episodes. Disease duration and number of depressive episodes were predictors of chronicity. Depressive polarity of the first episode and a higher number of depressive episodes predicted the occurrence of new depressive episodes. CONCLUSION: In general, BD outcome seems to be poor in the first year of monitoring, despite adequate treatment. There is a predominance of depressive symptoms, and previous depressive episodes are a predictor of new depressive episodes and worse outcome.

  14. [Results of therapeutics strategy of protein-energy wasting in chronic hemodialysis: a prospective study during 12 months].

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    Mpio, Ignace; Cleaud, Christine; Arkouche, Walid; Laville, Maurice

    2015-04-01

    Undernutrition (UN) in chronic hemodialysis (CHD) is a recurrent complication and constitutes a major public health problem. This work aims to evaluate the effects of our nutritional strategy (NS) developed among malnourished patients (pts) in CHD. This is a prospective observational study conducted for 12 months (M) in a cohort of 132 pts in CHD including 49 women, mean age 66 ± 16 years and the dialysis vintage 72 ± 74 months. This NS is based on the action of a multidisciplinary team; it provides for moderate UN pts one first phase of an optimization of protein and energy intake in the daily meals; then depending on the clinical course a second phase of oral supplementation at home. For severe UN pts, the optimization of daily meals and the oral supplements at home are reinforced with perdialytic oral supplementation. This modality was also prescribed for moderate UN pts with poor compliance at home. In case of loss of appetite, anorexia, gastrointestinal intolerance or inadequate oral intakes the relay is made by the intradialytic parenteral nutrition (IPN). Methods consist in the evaluation of the serum albumin (ALB), CRP, normalized PCR (nPCR), and Kt/V ratio of urea at baseline (day (D) 0) and at endpoint (M12). The ALB was measured by immunoturbidimetry. Three nutritional profiles were defined, severe UN if ALB ≤ 35 g/L, moderate UN if 35 treatment. The control of inflammation and optimizing dialysis are decisive factors of success. Copyright © 2014 Association Société de néphrologie. Published by Elsevier SAS. All rights reserved.

  15. Objectively measured physical activity and 12-month trajectories of neck-shoulder pain in workers: A prospective study in DPHACTO.

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    Hallman, David M; Birk Jørgensen, Marie; Holtermann, Andreas

    2017-05-01

    This study aimed to investigate the association between objectively measured physical activity at work and leisure and the intensity (mean level and time course) of neck-shoulder pain (NSP) over 12 months among male and female blue collar workers. Data were obtained from 625 blue collar workers from the Danish cohort DPHACTO. Physical activity was measured objectively at baseline using accelerometers. The percentage of time spent in physical activity (walking, climbing stairs, running and cycling) was calculated for both work and leisure time. Longitudinal data on the intensity of NSP (numerical rating scale 0-10) were collected using text messages every fourth week over 12 months. Linear mixed models were used to investigate the associations between occupational physical activity (OPA) and leisure time physical activity (LTPA) and the trajectories of the intensity of NSP, adjusted for individual, biomechanical and psychosocial factors, and baseline pain. OPA was not associated with the mean intensity of NSP over 12 months. LTPA was negatively associated with the mean intensity of NSP both among men ( B=-0.71, 95% CI -1.31 to -0.11) and women ( B=-0.85, 95% CI -1.57 to -0.13). Sex interactions on the 12-month trajectories of NSP showed that higher physical activity was associated with a slower reduction in NSP among men for OPA only ( B=0.03, 95% CI 0.01-0.05) and women for LTPA only ( B=0.05, 95% CI 0.00-0.09). We found that more time in LTPA was associated with a lower overall intensity of NSP over 12 months among blue collar workers. However, depending on sex and domain, high physical activity had an unfavourable effect on the course of NSP over 12 months.

  16. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

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    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  17. Cognitive status is a determinant of health resource utilization among individuals with a history of falls: a 12-month prospective cohort study.

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    Davis, J C; Dian, L; Khan, K M; Bryan, S; Marra, C A; Hsu, C L; Jacova, P; Chiu, B K; Liu-Ambrose, T

    2016-03-01

    Falls are a costly public health problem worldwide. The literature is devoid of prospective data that identifies factors among fallers that significantly drive health care resource utilization. We found that cognitive function--specifically, executive functions--and cognitive status are significant determinants of health resource utilization among older fallers. Although falls are costly, there are no prospective data examining factors among fallers that drive health care resource utilization. We identified key determinants of health resource utilization (HRU) at 6 and 12 months among older adults with a history of falls. Specifically, with the increasing recognition that cognitive impairment is associated with increased falls risk, we investigated cognition as a potential driver of health resource utilization. This 12-month prospective cohort study at the Vancouver Falls Prevention Clinic (n = 319) included participants with a history of at least one fall in the previous 12 months. Based on their cognitive status, participants were divided into two groups: (1) no mild cognitive impairment (MCI) and (2) MCI. We constructed two linear regression models with HRU at 6 and 12 months as the dependent variables for each model, respectively. Predictors relating to mobility, global cognition, executive functions, and cognitive status (MCI versus no MCI) were examined. Age, sex, comorbidities, depression status, and activities of daily living were included regardless of statistical significance. Global cognition, comorbidities, working memory, and cognitive status (MCI versus no MCI ascertained using the Montreal Cognitive Assessment (MoCA)) were significant determinants of total HRU at 6 months. The number of medical comorbidities and global cognition were significant determinants of total HRU at 12 months. MCI status was a determinant of HRU at 6 months among older adults with a history of falls. As such, efforts to minimize health care resource use related to falls

  18. Effect of bariatric surgery-induced weight loss on renal and systemic inflammation and blood pressure: a 12-month prospective study.

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    Fenske, Wiebke K; Dubb, Sukhpreet; Bueter, Marco; Seyfried, Florian; Patel, Karishma; Tam, Frederick W K; Frankel, Andrew H; le Roux, Carel W

    2013-01-01

    Bariatric surgery improves arterial hypertension and renal function; however, the underlying mechanisms and effect of different surgical procedures are unknown. In the present prospective study, we compared the 12-month follow-up results after Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and laparoscopic sleeve gastrectomy on weight loss, hypertension, renal function, and inflammatory status. A total of 34 morbidly obese patients were investigated before, one and 12 months after Roux-en-Y gastric bypass (n = 10), laparoscopic adjustable gastric banding (n = 13), and laparoscopic sleeve gastrectomy (n = 11) for hypertension, kidney function, urinary and serum cytokine levels of macrophage migration inhibitory factor, monocyte chemotactic protein-1, and chemokine ligand-18. At 12 months after surgery, the patients in all 3 treatment arms showed a significant decrease in the mean body mass index, mean arterial pressure, and urinary and serum inflammatory markers (all P .8 mg/L) had a marked improvement in renal function 12 months after surgery (P < .05). Surgically induced weight loss is associated with a marked decrease in renal and systemic inflammation and arterial hypertension and improvement in renal function in patients with pre-existing renal impairment. These effects appear to be independent of surgical procedure. The improvement in renal inflammation could be 1 of the mechanisms contributing to the beneficial effects of bariatric surgery on arterial blood pressure, proteinuria, and renal function. Copyright © 2013 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  19. Prevalence and patterns of depression and anxiety in hemodialysis patients: a 12-month prospective study on incident and prevalent populations.

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    Ng, Hui Juan; Tan, Wei Jie; Mooppil, Nandakumar; Newman, Stanton; Griva, Konstadina

    2015-05-01

    Depression is common in dialysis patients and has been shown to be associated with higher morbidity and mortality, but little is known about the course of symptoms over time. The current study set up to explore group and individual patterns of change in symptoms of anxiety and depression within the hemodialysis population and to identify socio-demographic, clinical, and psychological factors that may be associated with different trajectories of emotional distress. A total of 159 hemodialysis patients (n = 42 incident and n = 117 prevalent) completed the Hospital Anxiety and Depression Scale and social support and symptoms subscales from the Kidney Disease Quality of Life (Short Form) on two occasions 12 months apart. Clinical cut-offs were used to identify individual patterns of change in anxiety and depression symptoms across time, and analysis of variance (ANOVA) procedures were employed to establish potential correlates of these trajectories. Mean levels of anxiety and depression symptoms remained unchanged over 1 year with 44.7-54.1% of patients above cut-off at both baseline and follow-up. Individual-level analyses showed that the course of symptoms does not follow a single trajectory. While most patients had either persistent symptoms of distress (39.6% and 31.8% for depression and anxiety, respectively) or no/low symptoms of distress (32.1% and 36.9% for depression and anxiety, respectively), a total of 12.7-18.5% patients either had new-onset symptoms of depression/anxiety or symptoms diminishing over time. Patients with persisting or new-onset symptoms of depression or anxiety reported reduced perceived social support and quality of social interaction compared to the subgroups with low depressive/anxious symptoms. Different patterns of symptoms reflect heterogeneity in patients' emotional reactions and adjustment. More research is needed to identify patients at risk for emotional distress and to explore social support in the context of dialysis. Statement

  20. Assessment of psychosocial factors and predictors of psychopathology in a sample of heart transplantation recipients: a prospective 12-month follow-up.

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    Sánchez, Roberto; Baillès, Eva; Peri, Josep Maria; Bastidas, Anna; Pérez-Villa, Félix; Bulbena, Antonio; Pintor, Luis

    2016-01-01

    In the last decades, researchers of heart transplantation (HT) programs have attempted to identify the existence of psychosocial factors that might influence the clinical outcome before and after the transplantation. The first objective of this study is the prospective description of changes in psychiatric and psychosocial factors in a sample of HT recipients through a 12-month follow-up. The second goal is to identify predictors of psychopathology 1 year after HT. Pretransplant baseline assessment consisted of clinical form; Hospital Anxiety and Depression Scale (HADS); Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Structured Clinical Interview; Coping questionnaire (COPE); Five Factors Inventory Revised; Apgar-Family questionnaire and Multidimensional Health Locus of Control (MHLC). The assessment 1 year after HT consisted of HADS, COPE, Apgar-Family and MHLC. The sample included 78 recipients. During the waiting list period, 32.1% of them had a psychiatric disorder; personality factors profile was similar to the general population, and they showed adaptive coping strategies. Some changes in psychosocial factors were observed at 12 months after the surgery: lower scores of anxiety and depression, less necessity of publicly venting of feelings and a trend to an internal locus of control. Neuroticism and Disengagement pre-HT were predictors of psychopathology in the follow-up assessment. Pretransplant psychosocial screening is important and enables to find out markers of emotional distress like Neuroticism or Disengagement coping styles to identify patients who might benefit from psychiatric and psychological interventions. Successful HT involved some positive changes in psychosocial factors 12 months after the surgery beyond physical recovery. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Transobturator vaginal tape in comparison to tension-free vaginal tape: A prospective trial with a minimum 12 months follow-up

    Directory of Open Access Journals (Sweden)

    R B Nerli

    2009-01-01

    Full Text Available Background: The tension-free vaginal tape (TVT procedure is based on the integral theory that the midurethra has an important role in the continence mechanism. Transobturator vaginal tape (TOT is the same in concept as TVT but it differs from TVT in that, rather than passing through the retropubic space, sling materials are drawn through the obturator foramina. We prospectively compared TVT with TOT with respect to operation-related morbidity and surgical outcomes at a minimum follow up of 12 months. Materials and Methods: A total of 36 women with stress urinary incontinence (SUI were alternatively assigned to the TVT group (18 or the TOT group. Preoperative evaluation included urodynamic study and I-QOL questionnaire. One year after operation the surgical result, patient satisfaction, incontinence quality-of-life questionnaire, long-term complications, and uroflowmetry were evaluated in both groups. Results: The patient characteristics in both the TVT and TOT group were similar. Mean operating time was significantly shorter in the TOT group likened to the TVT group. Conclusions: Both the TVT and TOT procedures are minimally invasive and similar in operation-related morbidity. TOT appears to be as effective as TVT, and safer than TVT for the surgical treatment of SUI in women at 12 months follow-up.

  2. Continuous ambulatory right heart pressure measurements with an implantable hemodynamic monitor: a multicenter, 12-month follow-up study of patients with chronic heart failure.

    Science.gov (United States)

    Magalski, Anthony; Adamson, Philip; Gadler, Frederick; Böehm, Michael; Steinhaus, David; Reynolds, Dwight; Vlach, Kathryn; Linde, Cecilia; Cremers, Bodo; Sparks, Brandon; Bennett, Tom

    2002-04-01

    We describe the performance of an implantable hemodynamic monitor (IHM) that allows continuous recording of heart rate, patient activity levels, and right ventricular systolic, right ventricular diastolic, and estimated pulmonary artery diastolic pressures. Pressure parameters derived from the implantable monitor were correlated to measurements made with a balloon-tipped catheter to establish accuracy and reproducibility over time in patients with chronic heart failure (CHF). IHM devices were implanted in 32 patients with CHF (left ventricular ejection fraction, 29% +/- 11%; range, 14%-62%) and were tested with right heart catheterization at implantation and 3, 6, and 12 months later. Hemodynamic variables were digitally recorded simultaneously from the IHM and catheter. Values were recorded during supine rest, peak response of Valsalva maneuver, sitting, peak of a 2-stage (25-50 W) bicycle exercise test, and final rest period. The median of 21 paired beat-to-beat cardiac cycles was analyzed for each intervention. A total of 217 paired data values from all maneuvers were analyzed for 32 patients at implantation and 129 paired data values for 20 patients at 1 year. The IHM and catheter values were not different at baseline or at 1 year (P >.05). Combining all interventions, correlation coefficients were 0.96 and 0.94 for right ventricular systolic pressure, 0.96 and 0.83 for right ventricular diastolic pressure, and 0.87 and 0.87 for estimated pulmonary artery diastolic pressure at implantation and 1 year, respectively. The IHM and a standard reference pressure system recorded comparable right heart pressure values in patients with CHF. This implantable pressure transducer is accurate over time and provides a means to precisely monitor the hemodynamic condition of patients with CHF in a continuous fashion.

  3. Hospital Utilisation in Indigenous and Non-Indigenous Infants under 12 Months of Age in Western Australia, Prospective Population Based Data Linkage Study.

    Science.gov (United States)

    McAuley, Kimberley; McAullay, Daniel; Strobel, Natalie A; Marriott, Rhonda; Atkinson, David N; Marley, Julia V; Stanley, Fiona J; Edmond, Karen M

    2016-01-01

    Indigenous infants (infants aged under 12 months) have the highest hospital admission and emergency department presentation risks in Australia. However, there have been no recent reports comparing hospital utilisation between Indigenous and non-Indigenous infants. Our primary objective was to use a large prospective population-based linked dataset to assess the risk of all-cause hospital admission and emergency department presentation in Indigenous compared to non-Indigenous infants in Western Australia (WA). Secondary objectives were to assess the effect of socio-economic status (Index of Relative Socio-Economic Disadvantage [IRSD]) on hospital utilisation and to understand the causes of hospital utilisation. There were 3,382 (5.4%) Indigenous and 59,583 (94.6%) non-Indigenous live births in WA from 1 January 2010 to 31 December 2011. Indigenous infants had a greater risk of hospital admission (adjusted odds ratio [aOR] 1.90, 95% confidence interval [95% CI] 1.77-2.04, p = disadvantaged (IRSD 1) infants in the total cohort (35.7%) was similar to the risk in the least disadvantaged (IRSD 5) infants (30.6%) (aOR 1.04, 95% CI 0.96-1.13, p = 0.356). WA Indigenous infants have much higher hospital utilisation than non Indigenous infants. WA health services should prioritise Indigenous infants regardless of their socio economic status or where they live.

  4. Hospital Utilisation in Indigenous and Non-Indigenous Infants under 12 Months of Age in Western Australia, Prospective Population Based Data Linkage Study.

    Directory of Open Access Journals (Sweden)

    Kimberley McAuley

    Full Text Available Indigenous infants (infants aged under 12 months have the highest hospital admission and emergency department presentation risks in Australia. However, there have been no recent reports comparing hospital utilisation between Indigenous and non-Indigenous infants.Our primary objective was to use a large prospective population-based linked dataset to assess the risk of all-cause hospital admission and emergency department presentation in Indigenous compared to non-Indigenous infants in Western Australia (WA. Secondary objectives were to assess the effect of socio-economic status (Index of Relative Socio-Economic Disadvantage [IRSD] on hospital utilisation and to understand the causes of hospital utilisation.There were 3,382 (5.4% Indigenous and 59,583 (94.6% non-Indigenous live births in WA from 1 January 2010 to 31 December 2011. Indigenous infants had a greater risk of hospital admission (adjusted odds ratio [aOR] 1.90, 95% confidence interval [95% CI] 1.77-2.04, p = <0.001 and emergency department presentation (aOR 2.15, 95% CI 1.98-2.33, p = <0.001 compared to non-Indigenous infants. Fifty nine percent (59.0% of admissions in Indigenous children were classified as preventable compared to 31.2% of admissions in non-Indigenous infants (aOR 2.12, 95% CI 1.88-2.39. The risk of hospital admission in the most disadvantaged (IRSD 1 infants in the total cohort (35.7% was similar to the risk in the least disadvantaged (IRSD 5 infants (30.6% (aOR 1.04, 95% CI 0.96-1.13, p = 0.356.WA Indigenous infants have much higher hospital utilisation than non Indigenous infants. WA health services should prioritise Indigenous infants regardless of their socio economic status or where they live.

  5. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT as tobacco cigarettes substitute: a prospective 12-month randomized control design study.

    Directory of Open Access Journals (Sweden)

    Pasquale Caponnetto

    Full Text Available Electronic cigarettes (e-cigarettes are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a 'smoking' experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model ('Categoria'; Arbi Group Srl, Italy compared to its non-nicotine choice. GroupA (n = 100 received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100, a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100 received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed.Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline, with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants' perception and acceptance of the product under investigation was satisfactory.In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco

  6. Elevate Anterior/Apical: 12-Month Data Showing Safety and Efficacy in Surgical Treatment of Pelvic Organ Prolapse

    NARCIS (Netherlands)

    Stanford, Edward J.; Moore, Robert D.; Roovers, Jan-Paul W. R.; Courtieu, Christophe; Lukban, James C.; Bataller, Eduardo; Liedl, Bernhard; Sutherland, Suzette E.

    2013-01-01

    Objective: This study aimed to assess the safety and efficacy of the Elevate Anterior/Apical transvaginal mesh procedure in pelvic organ prolapse (POP) repair at 12-months follow-up. Methods: This prospective, multicenter, multinational study enrolled 142 patients experiencing anterior vaginal

  7. Proton Pump Inhibitors Intake and Iron and Vitamin B12 Status: A Prospective Comparative Study with a Follow up of 12 Months

    OpenAIRE

    Qorraj-Bytyqi, Hasime; Hoxha, Rexhep; Sadiku, Shemsedin; Bajraktari, Ismet H.; Sopjani, Mentor; Thaçi, Kujtim; Thaçi, Shpetim; Bahtiri, Elton

    2018-01-01

    BACKGROUND: Proton pump inhibitors (PPIs) represent the most widely prescribed antisecretory agents, but their prolonged use, may influence iron and vitamin B12 status, which could have important implications for clinical practice. AIM: We undertook this study aiming to investigate the association between PPIs use for 12 months and potential changes in iron and vitamin B12 status, as well as whether this potential association varies among four specific PPI drugs used in the study. MET...

  8. Your Baby's Growth: 12 Months

    Science.gov (United States)

    ... Safe Videos for Educators Search English Español Your Baby's Growth: 12 Months KidsHealth / For Parents / Your Baby's ... doubled his or her birth weight. Is My Baby Growing Normally? Babies' growth begins to slow as ...

  9. Developmental milestones record - 12 months

    Science.gov (United States)

    ... to 2 naps during the day SENSORY AND COGNITIVE DEVELOPMENT The typical 12-month-old: Begins pretend play ( ... Editorial team. Infant and Newborn Development Read more Toddler Development Read more NIH MedlinePlus Magazine Read more A. ...

  10. Pain and recovery after total knee arthroplasty: a 12-month follow-up after a prospective randomized study evaluating Nefopam and Ketamine for early rehabilitation.

    Science.gov (United States)

    Aveline, Christophe; Roux, Alain Le; Hetet, Hubert Le; Gautier, Jean F; Vautier, Pierre; Cognet, Fabrice; Bonnet, Francis

    2014-09-01

    Ketamine and nefopam has been documented to decrease pain intensity and improve rehabilitation after total knee arthroplasty (TKA). We conducted a follow-up study of a previously randomized clinical trial to determine the prevalence and risk factors of chronic pain 1 year after TKA and to assess the role of perioperative administration of ketamine and nefopam. The original randomized, double-blind trial evaluated postoperative pain in 75 patients scheduled for TKA who received either a 48-hour infusion of ketamine or nefopam compared with placebo. The current study has evaluated patients at 6 and 12 months for the presence of chronic pain defined as a visual analogue scale ≥40 mm during a stair-climbing test. Other outcomes were incidence of neuropathic pain evaluated (DN4 score), active flexion of the knee, and functional outcome (KOOS-PS score). A total of 69 patients completed the trial. The prevalence of chronic pain at 12 months was 17.4% (95% confidence interval [CI], 10.2%-27.9%) without difference between the ketamine (12.5%), nefopam (13.7%), and placebo groups (26.1%). Prevalence of neuropathic pain was 10.2% (95% CI, 3%-17.3%). Ketamine reduced DN4 scores (P=0.02), increased knee flexion (P=0.0007), and KOOS-PS scores (Ppain (odds ratio 4.54; 95% CI, 1.17-17.67). After TKA, the intensity of postoperative pain is a risk factor of chronic pain on movement. Intraoperative ketamine seems to improve long-term results of rehabilitation in this setting.

  11. Short Berg Balance Scale, BBS-9, as a predictor of fall risk among the aged: a prospective 12-month follow-up study.

    Science.gov (United States)

    Hohtari-Kivimäki, Ulla; Salminen, Marika; Vahlberg, Tero; Kivelä, Sirkka-Liisa

    2013-12-01

    The aim of this study was to assess the adequacy of the short, 9-item Berg Balance Scale (BBS-9) to predict fall risk among the community-dwelling aged. The subjects (n = 519) were derived from the participants in a multifactorial fall prevention intervention conducted in Pori, Finland. Receiver operating characteristic (ROC) analysis was used to determine the cut-off score for BBS-9 (range 0-36) to classify aged people with a fall risk during a 12-month follow-up. Logistic regression was used to analyse the relationship of potential confounders with fall risk. The association between the cut-off score for BBS-9 and fall risk was tested using the Chi-square test. In determining the cut-off score of BBS-9 to classify fall risk, the highest sensitivity (0.51) and specificity (0.57) (when both presumed to be above 0.50) sum score was within the limit range 32 scores or below. The area under curve (AUC) was significantly better in the model adjusted for significant confounders (vision and the number of regularly used drugs) (AUC = 0.64) than in the unadjusted model (AUC = 0.57) (p = 0.045). Among patients who scored 32 or below in BBS-9 the incidence of multiple falls was 20.0 %, whereas among those who scored 33-36 it was 15.7 %. BBS-9 with the cut-off score of 32/33 together with data on vision and the number of regularly used drugs predicted moderately the risk of falling among the community-dwelling aged.

  12. Effect of 12-month weekly professional oral hygiene care on the composition of the oral flora in dentate, dependent elderly residents: A prospective study.

    Science.gov (United States)

    Wikström, Maude; Kareem, Kawa L; Almståhl, Annica; Palmgren, Erika; Lingström, Peter; Wårdh, Inger

    2017-06-01

    To study the effect of weekly professional oral hygiene care on the proportion of micro-organisms associated with good oral health, caries, and periodontal and soft tissue diseases in oral biofilms in dentate, dependent elderly residents. Assisted oral hygiene care reduces the plaque score and number of micro-organisms in the oral biofilms in elderly residents. Less is known about the effect on the quality/composition of the remaining oral flora. Participants comprised 33 residents in the study and 35 in the control group. Dental status (≥10 natural teeth and no removable dentures to be included), plaque score, salivary secretion rate and prescription medicines were recorded. Duplicate samples, collected from supragingival plaque and tongue, were analysed using cultivation technique. Differences between and within groups were analysed using one-way and two-way ANOVA, respectively. At the baseline, the number of teeth in the participants (mean age, 83.7 ± 7.4 years) was 22.0 ± 4.5. The number of prescription medicines was 9.4 ± 4.5. Seventy-six per cent had low salivary secretion rate. Fifty per cent had "visible thick" supragingival plaque. At the 12-month registration, "no visible" or "visible but thin" plaque was recorded in 92% in the study group. The proportions of bacteria associated with good oral health and periodontal diseases were decreased over time, while the frequency and proportions of micro-organisms associated with caries and soft tissue infection were unaffected or increased. The results indicate that assisted oral hygiene care alone is not sufficient to regain an oral microbial flora associated with good oral health in dentate, dependent elderly residents. © 2016 John Wiley & Sons A/S and The Gerodontology Association. Published by John Wiley & Sons Ltd.

  13. Periodic progress report, 12 months

    DEFF Research Database (Denmark)

    Juhl, Thomas Winther; Nielsen, Jakob Skov

    The work performed during the first 12 months of the project started with the establishment of the cutting theory for the cutting of heavy sections (phase 1). Phase 2 comprises the design of the first laboratory version cutting head with optics, nozzle systems and interfaces for the various...

  14. Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: Results of a phase III, randomized, open-label, multicenter study.

    Science.gov (United States)

    Lal, Himal; Poder, Airi; Campora, Laura; Geeraerts, Brecht; Oostvogels, Lidia; Vanden Abeele, Carline; Heineman, Thomas C

    2018-01-02

    In phase III trials, 2 doses of a herpes zoster (HZ) subunit vaccine (HZ/su; 50 µg varicella-zoster virus glycoprotein E [gE] and AS01 B Adjuvant System) administered 2-months apart in older adults (≥50 and ≥70 years) demonstrated >90% efficacy in preventing HZ and had a clinically acceptable safety profile. Here we report immunogenicity, reactogenicity and safety following administration of 2 HZ/su doses at intervals longer than 2 months. In this Phase III, open-label trial conducted in the US and Estonia, 354 adults ≥50 years were randomized 1:1:1 to receive 2 HZ/su doses 2, 6, or 12 months apart. gE-specific humoral immune responses were evaluated at pre-vaccination, 1 and 12 months post-dose 2. Co-primary objectives were to compare immune responses to HZ/su 1 month post-dose 2 when given 6-months or 12-months apart to those administered 2-months apart. For each participant, safety information was collected from dose 1 to 12 months post-dose 2. 346 participants completed the study and 343 were included in the according-to-protocol cohort for immunogenicity. One month post-dose 2, vaccine response rates were 96.5% (97.5% confidence interval [CI]: 90.4; 99.2) and 94.5% (97.5% CI: 87.6; 98.3) for the 0, 6- and 0, 12-month schedules, respectively, both schedules meeting the pre-defined criterion. Non-inferiority of anti-gE geometric mean concentrations was demonstrated for HZ/su administered on 0, 6-month compared to a 0, 2-month schedule; however, HZ/su administered on a 0, 12-month schedule did not meet the non-inferiority criterion. Injection site pain was the most commonly reported solicited adverse event (AE). 26 participants each reported at least 1 serious AE; none were assessed as related to vaccination. Immune responses to HZ/su administered at 0, 6-month were non-inferior to those elicited by a 0, 2-month schedule. HZ/su exhibited a clinically acceptable safety profile for all dosing intervals. Clinicaltrials.gov (NCT01751165

  15. [Stinging nettle root extract (Bazoton-uno) in long term treatment of benign prostatic syndrome (BPS). Results of a randomized, double-blind, placebo controlled multicenter study after 12 months].

    Science.gov (United States)

    Schneider, T; Rübben, H

    2004-03-01

    Phytotherapy of BPS has a long tradition in Germany; nevertheless, data referring to single phytotherapeutic agents are rare. We therefore performed a randomized, double-blind, placebo-controlled multicenter study for 1 year with Bazoton uno (459 mg dry extract of stinging nettle roots) with 246 patients. The IPSS decreased on average from 18.7+/-0.3 to 13.0+/-0.5 with a statistically significant difference compared to placebo (18.5+/-0.3 to 13.8+/-0.5; p=0.0233). The median Q(max) increased by 3.0+/-0.4 ml/s in comparison to 2.9+/-0.4 ml/s (placebo), thus not statistically significantly different, as well as the median volume of residual urine, which changed from 35.5+/-3.4 ml before therapy to 20.0+/-2.8 ml and from 40.0+/-4.0 ml to 21.0+/-2.9 ml under placebo application. The number of adverse events (29/38) as well as urinary infections etc. (3/10 events) was smaller under Bazoton uno therapy compared to placebo. Treatment with Bazoton uno can therefore be considered a safe therapeutic option for BPS, especially for reducing irritative symptoms and BPS-associated complications due to the postulated antiphlogistic and antiproliferative effects of the stinging nettle extract. A strong increase of Q(max) or reduction of residual urine are not to be expected.

  16. Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

    Directory of Open Access Journals (Sweden)

    Rocco Totaro

    2015-01-01

    Full Text Available Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting. Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months. The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity. Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%. Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

  17. Short-term stress, but not mucosal healing nor depression was predictive for the risk of relapse in patients with ulcerative colitis: a prospective 12-month follow-up study.

    Science.gov (United States)

    Langhorst, Jost; Hofstetter, Anna; Wolfe, Fred; Häuser, Winfried

    2013-10-01

    Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. Psychological factors such as depression and stress are under debate to contribute to the risk of relapse. The impact of mucosal healing to reduce the risk of relapse had not been studied prospectively. The aim of this study was to identify whether depression and stress increase and mucosal healing reduces the risk of clinical relapse in patients with UC in clinical remission. Patients in clinical remission were followed prospectively for 1 year, or less if they relapsed. Endoscopy and histology score and long-term perceived stress (Perceived Stress Questionnaire) were measured at baseline. Mucosal healing was defined by a Mayo Endoscopy score of 0-1. Depression (Hospital Anxiety and Depression Scale) and acute perceived stress (Cohen Perceived Stress Scale) were measured at baseline and after 1, 3, 6, 9, and 12 months. A time-dependent multivariate Cox regression model determined the predictors of time to relapse. Seventy-five patients were included into final analysis, of which 28 (37.3%) relapsed. Short-term stress at the last visit before relapse (hazard ratio [HR] = 1.05, 95% confidence interval [CI] = 1.01-1.10) and male gender (HR = 2.38, 95% CI = 1.01-5.61), but not baseline mucosal healing (HR = 0.86, 95% CI = 0.35-2.11), baseline long-term stress (HR = 0.20, 95% CI = 0.01-3.31), and depression at the last visit before relapse (HR = 1.08, 95% CI = 0.95-1.22) were predictive for a relapse. Short-term stress but not depression nor mucosal healing was predictive for the risk of relapse in patients with UC in clinical remission. Larger multicentre studies are necessary to confirm our findings.

  18. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    , dialysis-related complications, dialysis-related expenses. RESULTS: The quality-of-life studies showed that significantly more time for work, family, and social activities was available to patients on APD compared to those on CAPD (p ...) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... were assessed at baseline and after 6 months by the self-administered short-form SF-36 generic health survey questionnaire supplemented with disease- and treatment-specific questions. Therapy costs were compared by evaluating dialysis-related expenses. MAIN OUTCOME MEASURES: Quality-of-life parameters...

  19. Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

    Energy Technology Data Exchange (ETDEWEB)

    Abbott, Andrea M.; Portschy, Pamela R. [Division of Surgical Oncology, University of Minnesota, Minneapolis, Minnesota (United States); Lee, Chung [Department of Radiation Oncology, University of Minnesota, Minneapolis, Minnesota (United States); Le, Chap T. [Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota (United States); Han, Linda K. [Department of Surgery, Indiana University, Indianapolis, Indiana (United States); Washington, Tara [Vantage Oncology, Redhawk and Wildomar Centers California, Wildomar, California (United States); Kinney, Michael [Center for Advanced Breast Care, Arlington Heights, Illinois (United States); Bretzke, Margit [Surgical Specialists of Minnesota, Minneapolis, Minnesota (United States); Tuttle, Todd M., E-mail: tuttl006@umn.edu [Division of Surgical Oncology, University of Minnesota, Minneapolis, Minnesota (United States)

    2013-11-01

    Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.

  20. Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

    International Nuclear Information System (INIS)

    Abbott, Andrea M.; Portschy, Pamela R.; Lee, Chung; Le, Chap T.; Han, Linda K.; Washington, Tara; Kinney, Michael; Bretzke, Margit; Tuttle, Todd M.

    2013-01-01

    Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended

  1. Surgical site infections in Italian Hospitals: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    Ippolito Giuseppe

    2008-03-01

    Full Text Available Abstract Background Surgical site infections (SSI remain a major clinical problem in terms of morbidity, mortality, and hospital costs. Nearly 60% of SSI diagnosis occur in the postdischarge period. However, literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence. A national prospective multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI, and the associated risk factors. Methods In 2002, a one-month, prospective national multicenter surveillance study was conducted in General and Gynecological units of 48 Italian hospitals. Case ascertainment of SSI was carried out using standardized surveillance methodology. To assess potential risk factors for SSI we used a conditional logistic regression model. We also reported the odds ratios of in-hospital and postdischarge SSI. Results SSI occurred in 241 (5.2% of 4,665 patients, of which 148 (61.4% during in-hospital, and 93 (38.6% during postdischarge period. Of 93 postdischarge SSI, sixty-two (66.7% and 31 (33.3% were detected through telephone interview and questionnaire survey, respectively. Higher SSI incidence rates were observed in colon surgery (18.9%, gastric surgery (13.6%, and appendectomy (8.6%. If considering risk factors for SSI, at multivariate analysis we found that emergency interventions, NNIS risk score, pre-operative hospital stay, and use of drains were significantly associated with SSI occurrence. Moreover, risk factors for total SSI were also associated to in-hospital SSI. Additionally, only NNIS, pre-operative hospital stay, use of drains, and antibiotic prophylaxis were associated with postdischarge SSI. Conclusion Our study provided information on risk factors for SSI in a large population in general surgery setting in Italy. Standardized postdischarge surveillance detected 38.6% of all SSI. We also compared risk factors for in-hospital and postdischarge SSI

  2. A prospective, multi-center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry.

    Science.gov (United States)

    Mustapha, Jihad A; Lansky, Alexandra; Shishehbor, Mehdi; Miles McClure, John; Johnson, Sarah; Davis, Thomas; Makam, Prakash; Crowder, William; Konstantino, Eitan; Attaran, Robert R

    2018-05-01

    The Chocolate BAR study is a prospective multicenter post-market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow-limiting dissection); secondary long-term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers between 2012 and 2014. The primary endpoint of procedure success was achieved in 85.1% of cases, and freedom from stenting occurred in 93.1%. Bail out stenting by independent adjudication occurred in 1.6% of cases and there were no flow limiting dissections. There was mean improvement of 2.1 Rutherford classes (±1.5) at 12-months, with 78.5% freedom from TLR, 97.2% freedom from major amputation, and 93.3% freedom from all-cause mortality. Core Lab adjudicated patency was 64.1% at 12 months. Use of the Chocolate balloon in an "all-comers" population achieved excellent procedural outcomes with low dissection rates and bailout stent use. © 2018 Wiley Periodicals, Inc.

  3. Endoscopic third ventriculostomy in children: prospective, multicenter results from the Hydrocephalus Clinical Research Network.

    Science.gov (United States)

    Kulkarni, Abhaya V; Riva-Cambrin, Jay; Holubkov, Richard; Browd, Samuel R; Cochrane, D Douglas; Drake, James M; Limbrick, David D; Rozzelle, Curtis J; Simon, Tamara D; Tamber, Mandeep S; Wellons, John C; Whitehead, William E; Kestle, John R W

    2016-10-01

    OBJECTIVE Endoscopic third ventriculostomy (ETV) is now established as a viable treatment option for a subgroup of children with hydrocephalus. Here, the authors report prospective, multicenter results from the Hydrocephalus Clinical Research Network (HCRN) to provide the most accurate determination of morbidity, complication incidence, and efficacy of ETV in children and to determine if intraoperative predictors of ETV success add substantially to preoperative predictors. METHODS All children undergoing a first ETV (without choroid plexus cauterization) at 1 of 7 HCRN centers up to June 2013 were included in the study and followed up for a minimum of 18 months. Data, including detailed intraoperative data, were prospectively collected as part of the HCRN's Core Data Project and included details of patient characteristics, ETV failure (need for repeat hydrocephalus surgery), and, in a subset of patients, postoperative complications up to the time of discharge. RESULTS Three hundred thirty-six eligible children underwent initial ETV, 18.8% of whom had undergone shunt placement prior to the ETV. The median age at ETV was 6.9 years (IQR 1.7-12.6), with 15.2% of the study cohort younger than 12 months of age. The most common etiologies were aqueductal stenosis (24.8%) and midbrain or tectal lesions (21.2%). Visible forniceal injury (16.6%) was more common than previously reported, whereas severe bleeding (1.8%), thalamic contusion (1.8%), venous injury (1.5%), hypothalamic contusion (1.5%), and major arterial injury (0.3%) were rare. The most common postoperative complications were CSF leak (4.4%), hyponatremia (3.9%), and pseudomeningocele (3.9%). New neurological deficit occurred in 1.5% cases, with 0.5% being permanent. One hundred forty-one patients had documented failure of their ETV requiring repeat hydrocephalus surgery during follow-up, 117 of them during the first 6 months postprocedure. Kaplan-Meier rates of 30-day, 90-day, 6-month, 1-year, and 2-year failure

  4. Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

    LENUS (Irish Health Repository)

    Unterscheider, Julia

    2013-04-01

    The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

  5. Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: 2-Year Follow-Up from a Prospective Multicenter Trial.

    Science.gov (United States)

    Duhon, Bradley S; Bitan, Fabien; Lockstadt, Harry; Kovalsky, Don; Cher, Daniel; Hillen, Travis

    2016-01-01

    Sacroiliac joint (SIJ) dysfunction is an underdiagnosed condition. Several published cohorts have reported favorable mid-term outcomes after SIJ fusion using titanium implants placed across the SIJ. Herein we report long-term (24-month) results from a prospective multicenter clinical trial. One hundred and seventy-two subjects at 26 US sites with SI joint dysfunction were enrolled and underwent minimally invasive SI joint fusion with triangular titanium implants. Subjects underwent structured assessments preoperatively and at 1, 3, 6, 12, 18 and 24 months postoperatively, including SIJ pain ratings (0-100 visual analog scale), Oswestry Disability Index (ODI), Short Form-36 (SF-36), EuroQOL-5D (EQ-5D), and patient satisfaction. Adverse events were collected throughout follow-up. All participating patients underwent a high-resolution pelvic CT scan at 1 year. Mean subject age was 50.9 years and 69.8% were women. SIJ pain was present for an average of 5.1 years prior to surgical treatment. SIJ pain decreased from 79.8 at baseline to 30.4 at 12 months and remained low at 26.0 at 24 months (pdysfunction, minimally invasive SI joint fusion using triangular titanium implants showed marked improvements in pain, disability and quality of life at 2 years. Imaging showed that bone apposition to implants was common but radiographic evidence of intraarticular fusion within the joint may take more than 1 year in many patients. This prospective multicenter clinical trial was approved by local or regional IRBs at each center prior to first patient enrollment. Informed consent with IRB-approved study-specific consent forms was obtained from all patients prior to participation.

  6. Functional Recovery and Life Satisfaction in the First Year After Severe Traumatic Brain Injury: A Prospective Multicenter Study of a Norwegian National Cohort.

    Science.gov (United States)

    Anke, Audny; Andelic, Nada; Skandsen, Toril; Knoph, Rein; Ader, Tiina; Manskow, Unn; Sigurdardottir, Solrun; Røe, Cecilie

    2015-01-01

    (1) To examine the impact of demographic and acute injury-related variables on functional recovery and life satisfaction after severe traumatic brain injury (sTBI) and (2) to test whether postinjury functioning, postconcussive symptoms, emotional state, and functional improvement are related to life satisfaction. Prospective national multicenter study. Level 1 trauma centers in Norway. 163 adults with sTBI. Functional recovery between 3 and 12 months postinjury measured with Glasgow Outcome Scale Extended, Rivermead Postconcussion Symptoms Questionnaire, Hospital Anxiety and Depression Scale, and satisfaction with life situation. 60% of cases experienced functional improvement from 3 to 12 months postinjury. Multivariate logistic regression analysis revealed that discharge to a rehabilitation department from acute care (odds ratio [OR] = 2.14; P life situation. Regression analysis revealed that older age (>65 years), low education, better functional outcome, and the absence of depressive and postconcussion symptoms were significant (P life satisfaction. Functional improvement was significantly associated with emotional state but not to life satisfaction. Following sTBI, approximately two-thirds of survivors improve between 3 and 12 months postinjury and are satisfied with their life. Direct discharge from acute care to specialized rehabilitation appears to increase functional recovery.

  7. Radiation-induced emesis: a prospective observational multicenter Italian trial

    International Nuclear Information System (INIS)

    1999-01-01

    Purpose: A prospective observational multicenter trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and evaluate the use of antiemetic drugs in radiation oncology clinical practice. Methods and Materials: Fifty-one Italian radiation oncology centers took part in this trial. The accrual lasted 2 consecutive weeks, only patients starting radiotherapy in this period were enrolled. Exclusion criteria were age under 18 years, and concomitant chemotherapy. Evaluation was based on diary cards filled in daily by patients during radiotherapy and 1 week after stopping it. Diary cards recorded the intensity of nausea and any episode of vomiting and retching. Prophylactic and symptomatic antiemetic drug prescriptions were also registered. Results: Nine hundred thirty-four patients entered the trial, and 914 were evaluable. Irradiated sites were: breast in 211 patients, pelvis in 210 patients, head and neck in 136 patients, thorax in 129 patients, brain in 52 patients, upper abdomen in 42 patients, skin and/or extremities in 37 patients, and other sites in 97 patients. Vomiting and nausea occurred in 17.1% and 37.3% of patients, respectively, and 38.7% patients had both vomiting and nausea. At multifactorial analysis, the only patient-related risk factor that was statistically significant was represented by previous experience with cancer chemotherapy. Moreover, two radiotherapy (RT)-related factors were significant risk factors for RIE, the irradiated site and field size. In fact, a statistically significant higher percentage of RIE was registered in upper abdomen RT and RT fields > 400 cm 2 . Although nonstatistically significant, patients receiving RT to the thorax and head and neck presented a higher incidence of RIE. Only a minority (14%) of patients receiving RT were given an antiemetic drug, and the prescriptions were more often symptomatic than prophylactic (9% vs. 5%, respectively). Different compounds and

  8. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  9. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study

    NARCIS (Netherlands)

    von Renteln, Daniel; Fuchs, Karl-Hermann; Fockens, Paul; Bauerfeind, Peter; Vassiliou, Melina C.; Werner, Yuki B.; Fried, Gerald; Breithaupt, Wolfram; Heinrich, Henriette; Bredenoord, Albert J.; Kersten, Jan F.; Verlaan, Tessa; Trevisonno, Michael; Rösch, Thomas

    2013-01-01

    Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months

  10. Treatment of traumatic thoracolumbar spine fractures : A multicenter prospective randomized study of operative versus nonsurgical treatment

    NARCIS (Netherlands)

    Siebenga, Jan; Leferink, Vincent J. M.; Segers, Michiel J. M.; Elzinga, Matthijs J.; Bakker, Fred C.; Haarman, Henk J. Th. M.; Rommens, Pol M.; ten Duis, Henk-Jan; Patka, Peter

    2006-01-01

    Study Design. Multicenter prospective randomized trial. Objective. To test the hypotheses that thoracolumbar AO Type A spine fractures without neurologic deficit, managed with short-segment posterior stabilization will show an improved radiographic outcome and at least the same functional outcome as

  11. Who Donates Their Body to Science? An International, Multicenter, Prospective Study

    Science.gov (United States)

    Cornwall, Jon; Perry, Gary F.; Louw, Graham; Stringer, Mark D.

    2012-01-01

    The altruistic act of body donation provides a precious resource for both teaching and researching human anatomy. However, relatively little is known about individuals who donate their bodies to science (donors), and in particular whether donors in different geographical locations share similar characteristics. A multicenter prospective survey of…

  12. Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

    Science.gov (United States)

    Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

    2012-05-01

    Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

  13. Fall predictors in older cancer patients: a multicenter prospective study.

    Science.gov (United States)

    Vande Walle, Nathalie; Kenis, Cindy; Heeren, Pieter; Van Puyvelde, Katrien; Decoster, Lore; Beyer, Ingo; Conings, Godelieve; Flamaing, Johan; Lobelle, Jean-Pierre; Wildiers, Hans; Milisen, Koen

    2014-12-15

    In the older population falls are a common problem and a major cause of morbidity, mortality and functional decline. The etiology is often multifactorial making the identification of fall predictors essential for preventive measures. Despite this knowledge, data on falls within the older cancer population are limited. The objective of this study was to evaluate the occurrence of falls within 2 to 3 months after cancer treatment decision and to identify predictors of falls (≥1 fall) during follow-up. Older patients (70 years or more) with a cancer treatment decision were included. At baseline, all patients underwent geriatric screening (G8 and Flemish Triage Risk Screening Tool), followed by a geriatric assessment including living situation, activities of daily living (ADL), instrumental activities of daily living (IADL), fall history in the past 12 months, fatigue, cognition, depression, nutrition, comorbidities and polypharmacy. Questionnaires were used to collect follow-up (2-3 months) data. Univariate and multivariate analyses were performed to identify predictors for falls (≥1 fall) during follow-up. At baseline, 295 (31.5%) of 937 included patients reported at least one fall in the past 12 months with 88 patients (29.5%) sustaining a major injury. During follow-up (2-3 months), 142 (17.6%) patients fell, of whom 51.4% fell recurrently and 17.6% reported a major injury. Baseline fall history in the past 12 months (OR = 3.926), fatigue (OR = 0.380), ADL dependency (OR = 0.492), geriatric risk profile by G8 (OR = 0.471) and living alone (OR = 1.631) were independent predictors of falls (≥1 fall) within 2-3 months after cancer treatment decision. Falls are a serious problem among older cancer patients. Geriatric screening and assessment data can identify patients at risk for a fall. A patient with risk factors associated with falls should undergo further evaluation and intervention to prevent potentially injurious fall incidents.

  14. Pylorus preserving pancreaticoduodenectomy versus standard Whipple procedure: a prospective, randomized, multicenter analysis of 170 patients with pancreatic and periampullary tumors

    NARCIS (Netherlands)

    K.T. Tran; H.G. Smeenk; C.H.J. van Eijck (Casper); G. Kazemier (Geert); W.C.J. Hop (Wim); J.W. Greve (Jan Willem); O.T. Terpstra (Onno); J.A. Zijlstra (Jan); P. Klinkert; J. Jeekel (Hans)

    2004-01-01

    textabstractOBJECTIVE: A prospective randomized multicenter study was performed to assess whether the results of pylorus-preserving pancreaticoduodenectomy (PPPD) equal those of the standard Whipple (SW) operation, especially with respect to duration of surgery, blood loss,

  15. The success of opening single chronic total occlusion lesions to improve myocardialviabilitytrial (SOS-COMEDY): Study protocol of a prospective multicenter study.

    Science.gov (United States)

    Huang, Rongchong; Song, Xiantao; Zhang, Haishan; Tian, Wen; Huang, Zheng; Zhang, Xingwei; Yang, Junqing; Zhang, Dongfeng; Wu, Jian; Zhong, Lei; Ting, Henry H

    2018-04-01

    Success of opening single (SOS)-comedy is a prospective multicenter study to compare the improvement in the decrease of myocardial viability by percutaneous coronary intervention (PCI) with that by optimal medical therapy (OMT) alone in patients with chronic total occlusion (CTO) of a single coronary artery. The risks and the benefits of both options (PCI and OMT) were listed in a CTO decision aid (DA). Eligible participants detected by invasive coronary angiography (ICA) or coronary computed tomography angiography (CCTA) were divided into PCI or OMT groups according to patients' choice after shared-decision making process with DA. Participants will undergo positron emission tomography/computed tomography (PET/CT), cardiac magnetic resonance (CMR) and transthoracic echocardiography (TTE), and proceed to ICA and revascularization if possible. Blinded core laboratory interpretation will be performed for ICA, CCTA, PET/CT, CMR, and TTE. All participants will be followed up for 12 months. The primary endpoint is the improvement to the decrease of myocardial viability from baseline assessed with the use of PET/CT after 12-month follow-up. All of the patients are appropriately consented before enrolling in this study, which has been approved by the Ethics Committee. Results of SOS-COMEDY will be helpful to develop a strategy for single CTO patients.

  16. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Pascal H Colson

    Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  17. Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

    Science.gov (United States)

    Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

    2016-01-01

    To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

  18. The Barrel vascular reconstruction device for endovascular coiling of wide-necked intracranial aneurysms: a multicenter, prospective, post-marketing study.

    Science.gov (United States)

    Gory, Benjamin; Blanc, Raphaël; Turjman, Francis; Berge, Jérôme; Piotin, Michel

    2018-02-02

    The Barrel vascular reconstruction device (Barrel VRD) is a novel stent with design features that allow endovascular coiling of wide-necked bifurcation aneurysms while preserving adjacent branches, without necessitating dual stent implantation. This study aimed to assess the safety and effectiveness of the Barrel VRD at 12-month follow-up. The Barrel VRD trial is a prospective, multicenter, observational post-marketing registry evaluating the use of the Barrel VRD for treatment of wide-necked bifurcation aneurysms. The primary effectiveness endpoint was successful aneurysm treatment measured by digital subtraction angiography with a Raymond-Roy occlusion grade of 1 or 2 in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture at 12 months. The primary safety endpoint was the absence of neurological death or major stroke at 12 months. Twenty patients were enrolled from December 2013 to December 2014. The device was implanted in 19 patients with 19 aneurysms (8 middle cerebral artery, 4 anterior communicating artery, 1 internal carotid artery terminus, 4 basilar artery aneurysms; mean dome height 5.7±1.91 mm; mean neck length 4.8±1.35 mm, mean dome-to-neck ratio 1.6±2.0). Coiling was performed in all cases. The primary effectiveness endpoint was achieved in 78.9% of subjects (15/19; 12 complete occlusions, 3 neck remnants), and the primary safety endpoint was 5.3% (1/19). This prospective study demonstrates that the Barrel VRD device resulted in ~80% occlusion rates and ~5% rates of neurological complications at 1 year after endovascular treatment of wide-necked bifurcation intracranial aneurysms. REGISTERED CLINICAL TRIAL: NCT02125097;Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. A multicenter prospective study of surgical audit systems.

    Science.gov (United States)

    Haga, Yoshio; Ikejiri, Koji; Wada, Yasuo; Takahashi, Tadateru; Ikenaga, Masakazu; Akiyama, Noriyoshi; Koike, Shoichiro; Koseki, Masato; Saitoh, Toshihiro

    2011-01-01

    This study was undertaken to evaluate a modified form of Estimation of Physiologic Ability and Surgical Stress (E-PASS) for surgical audit comparing with other existing models. Although several scoring systems have been devised for surgical audit, no nation-wide survey has been performed yet. We modified our previous E-PASS surgical audit system by computing the weights of 41 procedures, using data from 4925 patients who underwent elective digestive surgery, designated it as mE-PASS. Subsequently, a prospective cohort study was conducted in 43 national hospitals in Japan from April 1, 2005, to April 8, 2007. Variables for the E-PASS and American Society of Anesthesiologists (ASA) status-based model were collected for 5272 surgically treated patients. Of the 5272 patients, we also collected data for the Portsmouth modification of Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity (P-POSSUM) in 3128 patients. The area under the receiver operative characteristic curve (AUC) was used to evaluate discrimination performance to detect in-hospital mortality. The ratio of observed to estimated in-hospital mortality rates (OE ratio) was defined as a measure of quality. The numbers of variables required were 10 for E-PASS, 7 for mE-PASS, 20 for P-POSSUM, and 4 for the ASA status-based model. The AUC (95% confidence interval) values were 0.86 (0.79-0.93) for E-PASS, 0.86 (0.79-0.92) for mE-PASS, 0.81 (0.75-0.88) for P-POSSUM, and 0.73 (0.63-0.83) for the ASA status-based model. The OE ratios for mE-PASS among large-volume hospitals significantly correlated with those for E-PASS (R = 0.93, N = 9, P = 0.00026), P-POSSUM (R = 0.96, N = 6, P = 0.0021), and ASA status-based model (R = 0.83, N = 9, P = 0.0051). Because of its features of easy use, accuracy, and generalizability, mE-PASS is a candidate for a nation-wide survey.

  20. Electronic Cigarettes Efficacy and Safety at 12 Months: Cohort Study.

    Directory of Open Access Journals (Sweden)

    Lamberto Manzoli

    Full Text Available To evaluate the safety and efficacy as a tool of smoking cessation of electronic cigarettes (e-cigarettes, directly comparing users of e-cigarettes only, smokers of tobacco cigarettes only, and smokers of both.Prospective cohort study. Final results are expected in 2019, but given the urgency of data to support policies on electronic smoking, we report the results of the 12-month follow-up.Direct contact and structured questionnaires by phone or via internet.Adults (30-75 years were included if they were smokers of ≥1 tobacco cigarette/day (tobacco smokers, users of any type of e-cigarettes, inhaling ≥50 puffs weekly (e-smokers, or smokers of both tobacco and e-cigarettes (dual smokers. Carbon monoxide levels were tested in a sample of those declaring tobacco smoking abstinence.Sustained smoking abstinence from tobacco smoking at 12 months, reduction in the number of tobacco cigarettes smoked daily.We used linear and logistic regression, with region as cluster unit.Follow-up data were available for 236 e-smokers, 491 tobacco smokers, and 232 dual smokers (overall response rate 70.8%. All e-smokers were tobacco ex-smokers. At 12 months, 61.9% of the e-smokers were still abstinent from tobacco smoking; 20.6% of the tobacco smokers and 22.0% of the dual smokers achieved tobacco abstinence. Adjusting for potential confounders, tobacco smoking abstinence or cessation remained significantly more likely among e-smokers (adjusted OR 5.19; 95% CI: 3.35-8.02, whereas adding e-cigarettes to tobacco smoking did not enhance the likelihood of quitting tobacco and did not reduce tobacco cigarette consumption. E-smokers showed a minimal but significantly higher increase in self-rated health than other smokers. Non significant differences were found in self-reported serious adverse events (eleven overall.Adding e-cigarettes to tobacco smoking did not facilitate smoking cessation or reduction. If e-cigarette safety will be confirmed, however, the use of e

  1. Diagnostic performance of computed tomography coronary angiography (from the Prospective National Multicenter Multivendor EVASCAN Study).

    Science.gov (United States)

    Gueret, Pascal; Deux, Jean-François; Bonello, Laurent; Sarran, Anthony; Tron, Christophe; Christiaens, Luc; Dacher, Jean-Nicolas; Bertrand, David; Leborgne, Laurent; Renard, Cedric; Caussin, Christophe; Cluzel, Philippe; Helft, Gerard; Crochet, Dominique; Vernhet-Kovacsik, Hélène; Chabbert, Valérie; Ferrari, Emile; Gilard, Martine; Willoteaux, Serge; Furber, Alain; Barone-Rochette, Gilles; Jankowski, Adrien; Douek, Philippe; Mousseaux, Elie; Sirol, Marc; Niarra, Ralph; Chatellier, Gilles; Laissy, Jean-Pierre

    2013-02-15

    Computed tomographic coronary angiography (CTCA) has been proposed as a noninvasive test for significant coronary artery disease (CAD), but only limited data are available from prospective multicenter trials. The goal of this study was to establish the diagnostic accuracy of CTCA compared to coronary angiography (CA) in a large population of symptomatic patients with clinical indications for coronary imaging. This national, multicenter study was designed to prospectively evaluate stable patients able to undergo CTCA followed by conventional CA. Data from CTCA and CA were analyzed in a blinded fashion at central core laboratories. The main outcome was the evaluation of patient-, vessel-, and segment-based diagnostic performance of CTCA to detect or rule out significant CAD (≥50% luminal diameter reduction). Of 757 patients enrolled, 746 (mean age 61 ± 12 years, 71% men) were analyzed. They underwent CTCA followed by CA 1.7 ± 0.8 days later using a 64-detector scanner. The prevalence of significant CAD in native coronary vessels by CA was 54%. The rate of nonassessable segments by CTCA was 6%. In a patient-based analysis, sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios of CTCA were 91%, 50%, 68%, 83%, 1.82, and 0.18, respectively. The strongest predictors of false-negative results on CTCA were high estimated pretest probability of CAD (odds ratio [OR] 1.97, p <0.001), male gender (OR 1.5, p <0.002), diabetes (OR 1.5, p <0.0001), and age (OR 1.2, p <0.0001). In conclusion, in this large multicenter study, CTCA identified significant CAD with high sensitivity. However, in routine clinical practice, each patient should be individually evaluated, and the pretest probability of obstructive CAD should be taken into account when deciding which method, CTCA or CA, to use to diagnose its presence and severity. Copyright © 2013 Elsevier Inc. All rights reserved.

  2. Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD

    DEFF Research Database (Denmark)

    Miravitlles, Marc; Sliwinski, Pawel; Rhee, Chin Kook

    2018-01-01

    BACKGROUND: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHOD: This international, multicenter, prospective study aimed to validate the concept of control in COPD [control = stability (no...... exacerbations or impairment in CAT scores) + low impact (low level of symptoms)]. Data from the screening visit was used to: investigate the level of control, compare characteristics of patients according to the control status, and perform a sensitivity analysis of the levels of control using either clinical...... criteria or questionnaires (COPD Assessment Test -CAT- or Clinical COPD Questionnaire -CCQ-). RESULTS: A total of 314 patients were analysed, mean age was 68.5 years and mean FEV1 was 52.6% of predicted. According to the prespecified criteria 21% of patients were classified as controlled, all of them...

  3. MRI, PET/CT and ultrasound in the preoperative staging of endometrial cancer - A multicenter prospective comparative study

    DEFF Research Database (Denmark)

    Antonsen, Sofie Leisby; Jensen, Lisa Neerup; Loft, Annika

    2012-01-01

    OBJECTIVES: The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC). METHODS: 318 consecutive women with EC were included when...

  4. Prospective validation of a prognostic model for respiratory syncytial virus bronchiolitis in late preterm infants: a multicenter birth cohort study

    NARCIS (Netherlands)

    Blanken, M.O.; Koffijberg, H.; Nibbelke, E.E.; Rovers, M.M.; Bont, L.; Liem, K.D.; et al.,

    2013-01-01

    OBJECTIVES: This study aimed to update and validate a prediction rule for respiratory syncytial virus (RSV) hospitalization in preterm infants 33-35 weeks gestational age (WGA). STUDY DESIGN: The RISK study consisted of 2 multicenter prospective birth cohorts in 41 hospitals. Risk factors were

  5. Suicide Attempts within 12 Months of Treatment for Substance Use Disorders

    Science.gov (United States)

    Britton, Peter C.; Conner, Kenneth R.

    2010-01-01

    There are limited prospective data on suicide attempts (SA) during the months following treatment for substance use disorders (SUD), a period of high risk. In an analysis of the Drug Abuse Treatment Outcomes Study, a longitudinal naturalistic multisite study of treated SUDs, variables associated with SA in the 12 months following SUD treatment…

  6. Screening for distant metastases in head and neck cancer patients by chest CT or whole body FDG-PET: A prospective multicenter trial

    International Nuclear Information System (INIS)

    Senft, Asaf; Bree, Remco de; Hoekstra, Otto S.; Kuik, Dirk J.; Golding, Richard P.; Oyen, Wim J.G.; Pruim, Jan; Hoogen, Frank J. van den; Roodenburg, Jan L.N.; Leemans, C. Rene

    2008-01-01

    Background and purpose: The aim of the study was to define the added value of whole body FDG-PET in screening for distant metastases in patients with head and neck squamous cell carcinoma and risk factors. Materials and methods: In a multi-center prospective study between 1998 and 2003, 145 consecutive HNSCC patients with risk factors for distant metastases underwent chest CT and whole body FDG-PET for screening of distant metastases. The data of 92 evaluable patients who developed distant metastases or who had a follow-up of at least 12 months were analyzed. Besides their performance in clinical practice, the operational characteristics of PET and CT using ROC analyses were investigated. Results: Pretreatment screening identified distant metastases in 19 patients (21%). FDG-PET had a higher sensitivity (53% vs. 37%) and positive predictive value (80% vs. 75%) than CT. The combination of CT and FDG-PET had the highest sensitivity (63%). The ROC analyses of the five point ordinal scales revealed that the 'area under the curve' (AUC) of FDG-PET was significantly higher as compared to CT. Conclusion: In HNSCC patients with risk factors, pretreatment screening for distant metastases by chest CT is improved by FDG-PET

  7. Peripheral nerve field stimulation (PNFS) in chronic low back pain: a prospective multicenter study.

    Science.gov (United States)

    Kloimstein, Herwig; Likar, Rudolf; Kern, Michael; Neuhold, Josef; Cada, Miroslav; Loinig, Nadja; Ilias, Wilfried; Freundl, Brigitta; Binder, Heinrich; Wolf, Andreas; Dorn, Christian; Mozes-Balla, Eva Maria; Stein, Rolf; Lappe, Ivo; Sator-Katzenschlager, Sabine

    2014-02-01

    The goal of this study was to evaluate the long-term efficacy and safety of peripheral nerve field stimulation (PNFS) for chronic low back pain (cLBP). In this prospective, multicenter observational study, 118 patients were admitted to 11 centers throughout Austria and Switzerland. After a screening visit, all patients underwent a trial stimulation period of at least seven days before implantation of the permanent system. Leads were placed in the subcutaneous tissues of the lower back directly in the region of greatest pain. One hundred five patients were implanted with a permanent stimulating system. Patients' evaluation of pain and functional levels were completed before implantation and one, three, and six months after implantation. Adverse events, medication usage, and coverage of the painful area and predictive value of transcutaneous electrical nerve stimulation (TENS) were monitored. All pain and quality-of-life measures showed statistically significant improvement during the treatment period. These included the average pain visual analog scale, the Oswestry Disability Questionnaire, the Becks Depression Inventory, and the Short Form-12 item Health survey. Additionally, medication usage with opioids, nonsteroidal anti-inflammatory drugs, and anti-convulsants showed a highly significant reduction. Complications requiring surgical intervention were reported in 9.6% of the patients. The degree of coverage of painful areas seems to be an important criterion for efficacy of PNFS, whereas TENS is presumably no predictor. This prospective, multicenter study confirms that PNFS is an effective therapy for the management of cLBP. Significant improvements in many aspects of the pain condition were measured, and complications were minimal. © 2013 International Neuromodulation Society.

  8. Emotional and Social Development: 8 to 12 Months

    Science.gov (United States)

    ... Stages Listen Español Text Size Email Print Share Emotional and Social Development: 8 to 12 Months Page ... around strangers is usually one of the first emotional milestones your baby will reach. You may think ...

  9. Learning, Play, and Your 8- to 12-Month-Old

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Learning, Play, and Your 8- to 12-Month-Old ... these next few months. What Is My Child Learning? Your little one will make great strides in ...

  10. Feeding Your 8- to 12-Month-Old

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Feeding Your 8- to 12-Month-Old KidsHealth / For ... will help with the transition from the bottle . Feeding Safety Never leave your baby unattended while eating. ...

  11. A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

    Science.gov (United States)

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  12. Febrile urinary tract infection after pediatric kidney transplantation: a multicenter, prospective observational study.

    Science.gov (United States)

    Weigel, Friederike; Lemke, Anja; Tönshoff, Burkhard; Pape, Lars; Fehrenbach, Henry; Henn, Michael; Hoppe, Bernd; Jungraithmayr, Therese; Konrad, Martin; Laube, Guido; Pohl, Martin; Seeman, Tomáš; Staude, Hagen; Kemper, Markus J; John, Ulrike

    2016-06-01

    Febrile urinary tract infections (fUTIs) are common after kidney transplantation (KTx); however, prospective data in a multicenter pediatric cohort are lacking. We designed a prospective registry to record data on fUTI before and after pediatric KTx. Ninety-eight children (58 boys and 40 girls) ≤ 18 years from 14 mid-European centers received a kidney transplant and completed a 2-year follow-up. Posttransplant, 38.7% of patients had at least one fUTI compared with 21.4% before KTx (p = 0.002). Before KTx, fUTI was more frequent in patients with congenital anomalies of kidneys and urinary tract (CAKUT) vs. patients without (38% vs. 12%; p = 0.005). After KTx, fUTI were equally frequent in both groups (48.7% vs. 32.2%; p = 0.14). First fUTI posttransplant occurred earlier in boys compared with girls: median range 4 vs. 13.5 years (p = 0.002). Graft function worsened (p pediatric KTx, which is not restricted to patients with CAKUT; fUTIs have a negative impact on graft function during the infectious episode but not on 2-year graft outcome.

  13. Screening for primary aldosteronism in an argentinian population: a multicenter prospective study.

    Science.gov (United States)

    Leal Reyna, Mariela; Gómez, Reynaldo M; Lupi, Susana N; Belli, Susana H; Fenili, Cecilia A; Martínez, Marcela S; Ruibal, Gabriela F; Rossi, María A; Chervin, Raúl A; Cornaló, Dora; Contreras, Liliana N; Costa, Liliana; Nofal, María T; Damilano, Sergio A; Pardes, Ester M

    2015-10-01

    Primary aldosteronism (PA) is characterized by the autonomous overproduction of aldosterone. Its prevalence has increased since the use of the aldosterone (ALD)/plasma renin activity (PRA) ratio (ARR). The objective of this study is to determine ARR and ARC (ALD/plasma renin concentration ratio) cut-off values (COV) and their diagnostic concordance (DC%) in the screening for PA in an Argentinian population.Design multicenter prospective study. We studied 353 subjects (104 controls and 249 hypertensive patients). Serum aldosterone, PRA and ARR were determined. In 220 randomly selected subjects, 160 hypertensive patients and 60 controls, plasma renin concentration (PRC) was simultaneously measured and ARC was determined. According to the 95th percentile of controls, we determined a COV of 36 for ARR and 2.39 for ARC, with ALD ≥ 15 ng/dL. In 31/249 hypertensive patients, ARR was ≥ 36. PA diagnosis was established in 8/31 patients (23/31 patients did not complete confirmatory tests). DC% between ARR and ARC was calculated. A significant correlation between ARR and ARC (r = 0.742; p 0.3 ng/mL/h and PRC > 5 pg/mL. DC% for ARR and ARC above or below 36 and 2.39 was 79.1%, respectively. This first Argentinian multicenter study determined a COV of 36 for ARR and 2.39 for ARC. Applying an ARR ≥ 36 in the hypertensive group, we confirmed PA in a higher percentage of patients than the previously reported one in our population. As for ARC, further studies are needed for its clinical application, since DC% is acceptable only for medium range renin values.

  14. A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain

    NARCIS (Netherlands)

    A.L. Liem (Liong); M. Russo (Marc); F.J.P.M. Huygen (Frank); J.P. Van Buyten (Jean-Pierre); I. Smets (Ilse); P. Verrills (Paul); M. Cousins (Michael); C. Brooker (Charles); R. Levy (Richard); T. Deer (Timothy); J. Kramer (Jeffery)

    2013-01-01

    textabstractObjectives: This multicenter prospective trial was conducted to evaluate the clinical performance of a new neurostimulation system designed to treat chronic pain through the electrical neuromodulation of the dorsal root ganglia (DRG) neurophysiologically associated with painful regions

  15. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    OpenAIRE

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2012-01-01

    INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60)...

  16. Neuropsychological outcomes after Gamma Knife radiosurgery for mesial temporal lobe epilepsy: a prospective multicenter study.

    Science.gov (United States)

    Quigg, Mark; Broshek, Donna K; Barbaro, Nicholas M; Ward, Mariann M; Laxer, Kenneth D; Yan, Guofen; Lamborn, Kathleen

    2011-05-01

    To assess outcomes of language, verbal memory, cognitive efficiency and mental flexibility, mood, and quality of life (QOL) in a prospective, multicenter pilot study of Gamma Knife radiosurgery (RS) for mesial temporal lobe epilepsy (MTLE). RS, randomized to 20 Gy or 24 Gy comprising 5.5-7.5 ml at the 50% isodose volume, was performed on mesial temporal structures of patients with unilateral MTLE. Neuropsychological evaluations were performed at preoperative baseline, and mean change scores were described at 12 and 24 months postoperatively. QOL data were also available at 36 months. Thirty patients were treated and 26 were available for the final 24-month neuropsychological evaluation. Language (Boston Naming Test), verbal memory (California Verbal Learning Test and Logical Memory subtest of the Wechsler Memory Scale-Revised), cognitive efficiency and mental flexibility (Trail Making Test), and mood (Beck Depression Inventory) did not differ from baseline. QOL scores improved at 24 and 36 months, with those patients attaining seizure remission by month 24s accounting for the majority of the improvement. The serial changes in cognitive outcomes, mood, and QOL are unremarkable following RS for MTLE. RS may provide an alternative to open surgery, especially in those patients at risk of cognitive impairment or who desire a noninvasive alternative to open surgery. Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.

  17. Pediatric Patients Receiving Specialized Palliative Home Care According to German Law: A Prospective Multicenter Cohort Study

    Directory of Open Access Journals (Sweden)

    Silke Nolte-Buchholtz

    2018-05-01

    Full Text Available In Germany, every child with a life-limiting condition suffering from symptoms that cannot sufficiently be controlled is eligible by law for specialized pediatric palliative home care (SPPHC. It is the aim of this study to describe the demographic and clinical characteristics of children referred to SPPHC and to compare patients with cancer and non-cancer conditions. The prospective multicenter study includes data on 75 children (median age 7.7 years, 50.7% male. The majority had non-cancer conditions (72%. The most common symptoms were cognitive impairment, somatic pain, impairment in communication or swallowing difficulties. Swallowing difficulties, seizures, and spasticity occurred significantly more often in non-cancer patients (p < 0.01. Cancer patients received antiemetics significantly more often (permanent and on demand than non-cancer patients (p < 0.01. Significantly more non-cancer patients had some type of feeding tube (57.3% or received oxygen (33.3% (p < 0.01. Central venous catheters had been fitted in 20% of the patients, mostly in cancer patients (p < 0.001. Tracheostomy tubes (9.3% or ventilation (14.7% were only used in non-cancer patients. In conclusion, patients referred to SPPHC are a diverse cohort with complex conditions including a large range of neurologically originating symptoms. The care of pediatric palliative care patients with cancer is different to the care of non-cancer patients.

  18. "Burnout in Medical Oncology Fellows: a Prospective Multicenter Cohort Study in Brazilian Institutions".

    Science.gov (United States)

    Cubero, Daniel I G; Fumis, Renata Rego Lins; de Sá, Thiago Hérick; Dettino, Aldo; Costa, Felipe Osório; Van Eyll, Brigitte M R H Adam; Beato, Carlos; Peria, Fernanda Maris; Mota, Augusto; Altino, José; Azevedo, Sérgio Jobim; da Rocha Filho, Duílio Reis; Moura, Melba; Lessa, Álvaro Edson Ramos; Del Giglio, Auro

    2016-09-01

    Burnout syndrome is a common occurrence among oncologists. Doctors enrolled in residency programs in clinical oncology are exposed to similar risk factors; however, few data are available in this population. This study assessed the occurrence of burnout and associated factors among first-year residents at Brazilian institutions. The present prospective, multicenter, cohort study was conducted with doctors enrolled in residency programs in clinical oncology at Brazilian institutions affiliated with the public health system. The participants answered a sociodemographic questionnaire, the Maslach Burnout Inventory (MBI), Lipp's Stress Inventory, and the Beck Depression Inventory (BDI), upon admission to the program and 6 and 12 months later. Of 37 eligible residency programs in 2009, 11 (30.6 %) agreed to participate in the study. Fifty-four residents, representing 100 % of new admissions to the participating institutions, were included. Most of the participants met the criteria for severe burnout upon admission to the residency programs (emotional exhaustion in 49.0 % and depersonalization in 64.7 %). The scores on MBI domains emotional exhaustion and depersonalization increased significantly (p burnout increased to 88 % at the end of that first year. The present study found a high prevalence of burnout among doctors enrolled in residency programs in clinical oncology at Brazilian institutions. A large fraction of the participants met the criteria for burnout syndrome upon admission to the program, which suggests that the problem began during the course of the previous residency program in internal medicine.

  19. Effectiveness of Psychosocial Interventions in Complex Palliative Care Patients: A Quasi-Experimental, Prospective Multicenter Study.

    Science.gov (United States)

    Mateo-Ortega, Dolors; Gómez-Batiste, Xavier; Maté, Jorge; Beas, Elba; Ela, Sara; Lasmarias, Cristina; Limonero, Joaquín T

    2018-03-13

    To determine whether specific psychosocial interventions can ease discomfort in palliative care (PC) patients, particularly in those with high levels of pain or emotional distress. Changes in the psychological parameters of 8333 patients were assessed in a quasi-experimental, prospective, multicenter, single group pretest/post-test study. Psychosocial care was delivered by 29 psychosocial care teams (PSTs; 137 professionals). Pre- and post-intervention changes in these variables were assessed: mood, anxiety, and emotional distress. Patients were classified as complex, when presented with high levels of anxiety, mood, suffering (or perception of time as slow), and distress (or unease, or discomfort), or noncomplex. These groups were compared to assess changes in suffering-related parameters from baseline. Psychosocial interventions reduced patients' suffering. These interventions were more effective in complex patients. After successive psychosocial interventions, the level of suffering in complex patients decreased until close to parity with noncomplex patients, suggesting that patients with major complexity could benefit most from specific psychosocial treatment. These findings support the importance of assessing and treating patients' psychosocial needs.

  20. Determinants of Severity in Acute Pancreatitis: A Nation-wide Multicenter Prospective Cohort Study.

    Science.gov (United States)

    Sternby, Hanna; Bolado, Federico; Canaval-Zuleta, Héctor J; Marra-López, Carlos; Hernando-Alonso, Ana I; Del-Val-Antoñana, Adolfo; García-Rayado, Guillermo; Rivera-Irigoin, Robin; Grau-García, Francisco J; Oms, Lluís; Millastre-Bocos, Judith; Pascual-Moreno, Isabel; Martínez-Ares, David; Rodríguez-Oballe, Juan A; López-Serrano, Antonio; Ruiz-Rebollo, María L; Viejo-Almanzor, Alejandro; González-de-la-Higuera, Belén; Orive-Calzada, Aitor; Gómez-Anta, Ignacio; Pamies-Guilabert, José; Fernández-Gutiérrez-Del-Álamo, Fátima; Iranzo-González-Cruz, Isabel; Pérez-Muñante, Mónica E; Esteba, María D; Pardillos-Tomé, Ana; Zapater, Pedro; de-Madaria, Enrique

    2018-04-18

    The aim of this study was to compare and validate the different classifications of severity in acute pancreatitis (AP) and to investigate which characteristics of the disease are associated with worse outcomes. AP is a heterogeneous disease, ranging from uneventful cases to patients with considerable morbidity and high mortality rates. Severity classifications based on legitimate determinants of severity are important to correctly describe the course of disease. A prospective multicenter cohort study involving patients with AP from 23 hospitals in Spain. The Atlanta Classification (AC), Revised Atlanta Classification (RAC), and Determinant-based Classification (DBC) were compared. Binary logistic multivariate analysis was performed to investigate independent determinants of severity. A total of 1655 patients were included; 70 patients (4.2%) died. RAC and DBC were equally superior to AC for describing the clinical course of AP. Although any kind of organ failure was associated with increased morbidity and mortality, persistent organ failure (POF) was the most significant determinant of severity. All local complications were associated with worse outcomes. Infected pancreatic necrosis correlated with high morbidity, but in the presence of POF, it was not associated to higher mortality when compared with sterile necrotizing pancreatitis. Exacerbation of previous comorbidity was associated with increased morbidity and mortality. The RAC and DBC both signify an advance in the description and differentiation of AP patients. Herein, we describe the complications of the disease independently associated to morbidity and mortality. Our findings are valuable not only when designing future studies on AP but also for the improvement of current classifications.

  1. Surgical crown lengthening: a 12-month study - radiographic results

    Directory of Open Access Journals (Sweden)

    Daniela Eleutério Diniz

    2007-08-01

    Full Text Available OBJECTIVE: The purpose of this study was to perform a radiographic follow-up evaluation after a 12-month healing period, following crown lengthening surgery. MATERIAL AND METHODS: Twenty-three periodontally healthy subjects (mean age 32.5 years that required crown lengthening surgery in premolars were recruited. In a total of 30 premolars, full thickness flaps, osseous resection, and flap suturing were performed. The restorative margin was defined in the pre-surgical phase and maintained unaltered during the healing period, serving as a reference point. Standardized bitewing radiographs were taken before and after osseous reduction, and at 2, 3, 6, and 12-month healing periods. RESULTS: Intact lamina dura was observed at both mesial and distal alveolar crests only from the 3rd month. At 12-months, all alveolar crests presented lamina dura. The overall mean distance from the restorative margin to the alveolar crest achieved after osseous resection was 3.28±0.87 mm at mesial and 2.81±0.51 mm at distal sites. No significant radiographic changes in the bone crest were observed during a 12-month healing period. CONCLUSION: The findings of this study suggest that the radiographic proximal bone level observed on bitewing radiographs following crown lengthening surgery can be used as a reference to predict the future level of the healed alveolar crest.

  2. Perceptual Learning: 12-Month-Olds' Discrimination of Monkey Faces

    Science.gov (United States)

    Fair, Joseph; Flom, Ross; Jones, Jacob; Martin, Justin

    2012-01-01

    Six-month-olds reliably discriminate different monkey and human faces whereas 9-month-olds only discriminate different human faces. It is often falsely assumed that perceptual narrowing reflects a permanent change in perceptual abilities. In 3 experiments, ninety-six 12-month-olds' discrimination of unfamiliar monkey faces was examined. Following…

  3. Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases

    International Nuclear Information System (INIS)

    Bagla, Sandeep; Sayed, Dawood; Smirniotopoulos, John; Brower, Jayson; Neal Rutledge, J.; Dick, Bradley; Carlisle, James; Lekht, Ilya; Georgy, Bassem

    2016-01-01

    BackgroundRadiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM.MethodsFifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval.ResultsTwenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported.ConclusionRFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

  4. Health care utilization in patients with gout: a prospective multicenter cohort study.

    Science.gov (United States)

    Singh, Jasvinder A; Bharat, Aseem; Khanna, Dinesh; Aquino-Beaton, Cleopatra; Persselin, Jay E; Duffy, Erin; Elashoff, David; Khanna, Puja P

    2017-05-31

    All published studies of health care utilization in gout have been cross-sectional to date, and most used a patient-reported diagnosis of gout. Our objective was to assess health care utilization and its predictors in patients with physician-confirmed gout in a prospective cohort study. In a multi-center prospective cohort study of U.S. veterans with rheumatologist-confirmed gout (N = 186; two centers), we assessed patient self-reported overall and gout-specific health care utilization with the Gout Assessment Questionnaire (GAQ) every 3-months for a 9-month period. Comparisons were made using the student's t test or the chi-square, Wilcoxon rank sum test or Fisher exact test, as appropriate. Mixed effects Poisson regression was used to assess potential correlates of gout-related health care utilization. Mean age was 64.6 years, 98% were men, 13% Hispanic or Latino, 32% were African-American, 6% did not graduate high school, mean serum urate was 8.3 and mean Deyo-Charlson score was 3.1. During the past year, mean gout-related visits were as follows: rheumatologist, 1.5; primary care physician, 2 visits; ≥1 inpatient visits, 7%; ≥1 ER visits, 26%; and urgent care/walk-in visit, 33%. In longitudinal analyses, African-American race and gout flares in the last 3 months were associated with significantly higher rate ratio of gout-related outpatient visits. African-American race and lack of college education were associated with significantly higher rate ratio for gout-related urgent visits and overnight stays. African-American race and recent gout flares were associated with higher outpatient utilization and African-American race and no college education with higher urgent or inpatient utilization. Future studies should examine whether modifiable predictors of utilization can be targeted to reduce healthcare utilization in patients with gout.

  5. Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases.

    Science.gov (United States)

    Bagla, Sandeep; Sayed, Dawood; Smirniotopoulos, John; Brower, Jayson; Neal Rutledge, J; Dick, Bradley; Carlisle, James; Lekht, Ilya; Georgy, Bassem

    2016-09-01

    Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported. RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

  6. Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases

    Energy Technology Data Exchange (ETDEWEB)

    Bagla, Sandeep, E-mail: sandeep.bagla@gmail.com [Vascular Institute of Virginia, LLC (United States); Sayed, Dawood [University of Kansas Medical Center (United States); Smirniotopoulos, John [New York Presbyterian Hospital/Weill Cornell Medical Center (United States); Brower, Jayson [Providence Sacred Heart Medical Center and Children’s Hospital (United States); Neal Rutledge, J. [Seton Medical Center (United States); Dick, Bradley [Suburban Hospital (United States); Carlisle, James [St. Mark’s Hospital (United States); Lekht, Ilya [University of Southern California (United States); Georgy, Bassem [San Diego Imaging (United States)

    2016-09-15

    BackgroundRadiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM.MethodsFifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval.ResultsTwenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported.ConclusionRFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

  7. The sustained effect (12 months) of a single-dose vectored thermal pulsation procedure for meibomian gland dysfunction and evaporative dry eye.

    Science.gov (United States)

    Blackie, Caroline A; Coleman, Christy A; Holland, Edward J

    2016-01-01

    To evaluate the sustained effect (up to 1 year) of a single, 12-minute vectored thermal pulsation (VTP) treatment in improving meibomian gland function and dry eye symptoms in patients with meibomian gland dysfunction and evaporative dry eye. The prospective, multicenter, open-label clinical trial included 200 subjects (400 eyes) who were randomized to a single VTP treatment (treatment group) or twice-daily, 3-month, conventional warm compress and eyelid hygiene therapy (control group). Control group subjects received crossover VTP treatment at 3 months (crossover group). Effectiveness measures of meibomian gland secretion (MGS) and dry eye symptoms were evaluated at baseline and 1, 3, 6, 9, and 12 months. Subjects with inadequate symptom relief could receive additional meibomian gland dysfunction therapy after 3 (treatment group) and 6 months (crossover group). At 3 months, the treatment group had greater mean improvement in MGS (Pdry eye symptoms (P=0.0068), compared to controls. At 12 months, 86% of the treatment group had received only one VTP treatment, and sustained a mean improvement in MGS from 6.4±3.7 (baseline) to 17.3±9.1 (Pdry eye symptoms from 44.1±20.4 to 21.6±21.3 (Pdry eye symptoms from 49.1±21.0 to 24.0±23.2 (Pdry eye symptoms, over 12 months. A single VTP treatment provides significantly greater mean improvement in meibomian gland function and dry eye symptoms as compared to a conventional, twice-daily, 3-month regimen. Early VTP intervention for meibomian gland dysfunction is associated with improved treatment outcomes.

  8. Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

    Science.gov (United States)

    Lequin, Michiel B; Barth, Martin; Thomė, Claudius; Bouma, Gerrit J

    2012-12-01

    Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor. We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up. At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed. The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

  9. In-hospital management and outcome of patients on warfarin undergoing coronary stent implantation: results of the multicenter, prospective WARfarin and coronary STENTing (WAR-STENT) registry.

    Science.gov (United States)

    Rubboli, Andrea; Sciahbasi, Alessandro; Briguori, Carlo; Saia, Francesco; Palmieri, Cataldo; Moroni, Luigi Andrea; Calabrò, Paolo; Leone, Antonio Maria; Franco, Nicoletta; Valgimigli, Marco; Varani, Elisabetta; Santi, Michela; Pasqualini, Paola; Capecchi, Alessandro; Piccalò, Giacomo; Margheri, Massimo; di Pasquale, Giuseppe; Galvani, Marcello; Bolognese, Leonardo; Gonzini, Lucio; Maggioni, Aldo Pietro

    2013-04-01

    The in-hospital management of patients on warfarin undergoing coronary stent implantation (PCI-S) is variable, and the in-hospital outcome incompletely defined. To determine the adherence to the current recommendations, and the incidence of adverse events, we carried out the prospective, multicenter, observational WARfarin and coronary STENTing (WAR-STENT) registry (ClinicalTrials.gov identifier NCT00722319). All consecutive patients on warfarin undergoing PCI-S at 37 Italian centers were enrolled and followed for 12 months. Outcome measures were: major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, need for urgent revascularization, stroke, and venous thromboembolism, and major and minor bleeding. In this paper, we report the in-hospital findings. Out of the 411 patients enrolled, 92% were at non-low (ie, moderate or high) thromboembolic risk. The radial approach and bare-metal stents were used in 61% and 60% of cases, respectively. Drug-eluting stents were essentially reserved to patients with diabetes, which in turn, significantly predicted the implantation of drug-eluting stents (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.29-3.17; P=.002). The in-hospital MACE and major bleeding rates were 2.7% and 2.1%, respectively. At discharge, triple therapy (TT) of warfarin, aspirin, and clopidogrel was prescribed to 76% of patients. Prescription of TT was significantly more frequent in the non-low thromboembolic risk group. Non-low thromboembolic risk, in turn, was a significant predictor of TT prescription (OR, 11.2; 95% CI, 4.83-26.3; P<.0001). In conclusion, real-world warfarin patients undergoing PCI-S are largely managed according to the current recommendations. As a consequence, the risk of in-hospital MACE and major bleedings appears limited and acceptable.

  10. Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial.

    Science.gov (United States)

    Götberg, Matthias; Christiansen, Evald H; Gudmundsdottir, Ingibjörg; Sandhall, Lennart; Omerovic, Elmir; James, Stefan K; Erlinge, David; Fröbert, Ole

    2015-11-01

    Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up. iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1:1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality. The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Stability of cocaine impurity profiles during 12 months of storage

    DEFF Research Database (Denmark)

    Nielsen, Louise Stride; Villesen, Palle; Lindholst, Christian

    2016-01-01

    During the lifetime of a cocaine batch from production end to consumption, several alterations may occur, leading to possible changes in the original impurity profile. Such profile changes may eventually result in erroneous forensic evaluations. In the present study, the stability of both...... the alkaloid and the residual solvent impurity profiles of cocaine were evaluated over a period of 12 months under different storage conditions (temperature, purity and weight) using GC-MS and HS-GC-MS, respectively. The sample purity (p ... profile. The most significant change was observed in low purity samples stored at 37 °C. In contrast, no changes were observed in the residual solvent profile at all storage conditions for the entire 12-month study period. This finding indicates...

  12. Maternal Antenatal Depression and Infant Disorganized Attachment at 12 months

    OpenAIRE

    Hayes, Lisa J.; Goodman, Sherryl H.; Carlson, Elizabeth

    2012-01-01

    Although high rates of attachment disorganization have been observed in infants of depressed mothers, little is known about the role of antenatal depression as a precursor to infant attachment disorganization. The primary aim of this study was to examine associations between maternal antenatal depression and infant disorganization at 12 months in a sample of women (N = 79) at risk for perinatal depression. A secondary aim was to test the roles of maternal postpartum depression and maternal pa...

  13. Urinary leukotriene E4 at 12 months and influencing factors

    Directory of Open Access Journals (Sweden)

    K Stencel-Gabriel

    2016-01-01

    • 3.        Department of Gynecology, Obstetrics and Oncological Gynecology, Bytom, Medical University of Silesia       Corresponding author: Krystyna Stencel-Gabriel ul. Batorego 15 41-902 Bytom   Keywords: leukotriene E4, infants, allergy, urine.   Summary Objective LTE4 is the end point of cysLTs pathway and its only stable product. Its role was discussed in asthma and AEDS. We aimed to investigate the impact of genetic and environmental factors ( sex, maternal positive family atopy history, breastfeeding, passive smoking and pet exposure . 60 newborns ( including 30 boys were enrolled in the study. Each child was examined at 12 months and urine samples for urinary LTE4 measurement were collected. All samples were processed using ACETM Enzyme Immunoassay Kit ( Cayman Chemical, Ann Arbor, MI, USA . The mean level of urinary LTE4 at 12 months was 186,99 pg/ml ( median: 159,0; CI 95%: 157,79- 221,59 . The Shapiro- Wilk test showed that the distribution of the levels of urinary LTE4 were abnormal. 12- month- old girls had higher urinary LTE4 levels than boys ( mean: 270,50 vs. 193,55 , but maternal positive atopy history, pet exposure, tobacco smoking or length of breastfeeding had no impact on urinary LTE4 excretion. Conclusions In conclusion, most of genetic or environmental factors do not change levels of urinary LTE4 in infants.

  14. Mechanical Ventilation and ARDS in the ED: A Multicenter, Observational, Prospective, Cross-sectional Study.

    Science.gov (United States)

    Fuller, Brian M; Mohr, Nicholas M; Miller, Christopher N; Deitchman, Andrew R; Levine, Brian J; Castagno, Nicole; Hassebroek, Elizabeth C; Dhedhi, Adam; Scott-Wittenborn, Nicholas; Grace, Edward; Lehew, Courtney; Kollef, Marin H

    2015-08-01

    There are few data regarding mechanical ventilation and ARDS in the ED. This could be a vital arena for prevention and treatment. This study was a multicenter, observational, prospective, cohort study aimed at analyzing ventilation practices in the ED. The primary outcome was the incidence of ARDS after admission. Multivariable logistic regression was used to determine the predictors of ARDS. We analyzed 219 patients receiving mechanical ventilation to assess ED ventilation practices. Median tidal volume was 7.6 mL/kg predicted body weight (PBW) (interquartile range, 6.9-8.9), with a range of 4.3 to 12.2 mL/kg PBW. Lung-protective ventilation was used in 122 patients (55.7%). The incidence of ARDS after admission from the ED was 14.7%, with a mean onset of 2.3 days. Progression to ARDS was associated with higher illness severity and intubation in the prehospital environment or transferring facility. Of the 15 patients with ARDS in the ED (6.8%), lung-protective ventilation was used in seven (46.7%). Patients who progressed to ARDS experienced greater duration in organ failure and ICU length of stay and higher mortality. Lung-protective ventilation is infrequent in patients receiving mechanical ventilation in the ED, regardless of ARDS status. Progression to ARDS is common after admission, occurs early, and worsens outcome. Patient- and treatment-related factors present in the ED are associated with ARDS. Given the limited treatment options for ARDS, and the early onset after admission from the ED, measures to prevent onset and to mitigate severity should be instituted in the ED. ClinicalTrials.gov; No.: NCT01628523; URL: www.clinicaltrials.gov.

  15. A prospective, multicenter study of pharmacist activities resulting in medication error interception in the emergency department.

    Science.gov (United States)

    Patanwala, Asad E; Sanders, Arthur B; Thomas, Michael C; Acquisto, Nicole M; Weant, Kyle A; Baker, Stephanie N; Merritt, Erica M; Erstad, Brian L

    2012-05-01

    The primary objective of this study is to determine the activities of pharmacists that lead to medication error interception in the emergency department (ED). This was a prospective, multicenter cohort study conducted in 4 geographically diverse academic and community EDs in the United States. Each site had clinical pharmacy services. Pharmacists at each site recorded their medication error interceptions for 250 hours of cumulative time when present in the ED (1,000 hours total for all 4 sites). Items recorded included the activities of the pharmacist that led to medication error interception, type of orders, phase of medication use process, and type of error. Independent evaluators reviewed all medication errors. Descriptive analyses were performed for all variables. A total of 16,446 patients presented to the EDs during the study, resulting in 364 confirmed medication error interceptions by pharmacists. The pharmacists' activities that led to medication error interception were as follows: involvement in consultative activities (n=187; 51.4%), review of medication orders (n=127; 34.9%), and other (n=50; 13.7%). The types of orders resulting in medication error interceptions were written or computerized orders (n=198; 54.4%), verbal orders (n=119; 32.7%), and other (n=47; 12.9%). Most medication error interceptions occurred during the prescribing phase of the medication use process (n=300; 82.4%) and the most common type of error was wrong dose (n=161; 44.2%). Pharmacists' review of written or computerized medication orders accounts for only a third of medication error interceptions. Most medication error interceptions occur during consultative activities. Copyright © 2011. Published by Mosby, Inc.

  16. Prospective multicenter survey on the clinical management of pediatric contact dermatitis.

    Science.gov (United States)

    Ruggiero, Giuseppe; Carnevale, Claudia; Diociaiuti, Andrea; Arcangeli, Fabio; El Hachem, May

    2016-12-01

    Contact dermatitis can be defined as an inflammatory process affecting the skin surface and induced by contact with chemical, physical and/or biotic agents in the environment. It causes lesions to skin, mucosae and semi-mucosae by means of allergic and irritant pathogenic mechanisms. Among the main triggers of contact dermatitis in the pediatric age are chemical or physical agents, which cause irritant contact dermatitis (ICD), and sensitizers, which cause a tissue damage through an allergic mechanism (allergic contact dermatitis [ACD]). A prospective, multicenter, observational study was carried out in 204 children affected by contact dermatitis, aged up to 14 years, and enrolled by pediatricians from 7 different Italian provinces. The diagnosis of contact dermatitis was based on the pediatrician's clinical evaluation. The data were collected through a series of simple and multiple choice questions, anonymously filled out by pediatricians. In 90% of cases (184 of 204 patients), there was complete remission of contact dermatitis, with no cases of worsening. No adverse events were observed, either. The effectiveness of the therapy was rated as "very effective" by 84.4% of the parents and 86.8% of the pediatricians. In only 10 patients a new therapy had to be prescribed. Contact dermatitis is a heterogeneous inflammatory skin disease induced by contact with different kinds of environmental agents. Cutaneous manifestations are highly variable and depend on the modality of contact, on the causative agent and on the pathogenesis. This Italian experience of a clinical approach to contact dermatitis stresses the need of daily skin care through different therapeutic strategies, based on the diagnosis, the clinical severity and the parents and children compliance. The first therapeutic measure to be implemented is prevention, through the removal of the causative agent and the use of protective devices. Indeed, preserving the skin's barrier function is an important goal and

  17. The Effectiveness and Efficiency of Inpatient Rehabilitation Services in Thailand: A Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Vilai Kuptniratsaikul

    2016-01-01

    Full Text Available Objective To investigate the effectiveness and efficiency of inpatient rehabilitation. Methods A total of 2,081 patients across 14 hospitals were recruited in this prospective, multicenter cohort study. Data on the diagnoses, types of admission, length of stay (LOS, and functional ability score based on a modified Barthel index (BI at admission (BIa and at discharge (BId were collected. Effectiveness was defined as the difference of BI (ΔBI and efficiency as ΔBI divided by LOS. Results The majority of patients were diagnosed with spinal cord injury and stroke (41.8% and 37.5%, respectively. The mean age was 52.4 ± 18.6 years with a mean LOS of 23.9 ± 19.9 days, BIa of 9.4 ± 6.1, and BId of 12.3 ± 5.7. The overall effectiveness and efficiency were 2.9 ± 3.4 and 0.16 ± 0.30 scores/day, respectively; stroke rehabilitation provided the most effective and efficient BI improvement compared with rehabilitation for other diseases. Most patients (54.5% received intensive functional rehabilitation, which was the most effective and efficient program (4.4 ± 3.6 and 0.23 ± 0.32 scores/day, respectively; the efficiency of the intensive program was not different among various diseases (P = 0.726. Conclusion Stroke rehabilitation had the highest efficiency compared with rehabilitation for other neurological diseases. The most efficient type of admission was intensive rehabilitation, regardless of the disease being treated.

  18. Office gel sonovaginography for the prediction of posterior deep infiltrating endometriosis: a multicenter prospective observational study.

    Science.gov (United States)

    Reid, S; Lu, C; Hardy, N; Casikar, I; Reid, G; Cario, G; Chou, D; Almashat, D; Condous, G

    2014-12-01

    To use office gel sonovaginography (SVG) to predict posterior deep infiltrating endometriosis (DIE) in women undergoing laparoscopy. This was a multicenter prospective observational study carried out between January 2009 and February 2013. All women were of reproductive age, had a history of chronic pelvic pain and underwent office gel SVG assessment for the prediction of posterior compartment DIE prior to laparoscopic endometriosis surgery. Gel SVG findings were compared with laparoscopic findings to determine the diagnostic accuracy of office gel SVG for the prediction of posterior compartment DIE. In total, 189 women underwent preoperative gel SVG and laparoscopy for endometriosis. At laparoscopy, 57 (30%) women had posterior DIE and 43 (23%) had rectosigmoid/anterior rectal DIE. For the prediction of rectosigmoid/anterior rectal (i.e. bowel) DIE, gel SVG had an accuracy of 92%, sensitivity of 88%, specificity of 93%, positive predictive value (PPV) of 79%, negative predictive value (NPV) of 97%, positive likelihood ratio (LR+) of 12.9 and negative likelihood ratio (LR-) of 0.12 (P = 3.98E-25); for posterior vaginal wall and rectovaginal septum (RVS) DIE, respectively, the accuracy was 95% and 95%, sensitivity was 18% and 18%, specificity was 99% and 100%, PPV was 67% and 100%, NPV was 95% and 95%, LR+ was 32.4 and infinity and LR- was 0.82 and 0.82 (P = 0.009 and P = 0.003). Office gel SVG appears to be an effective outpatient imaging technique for the prediction of bowel DIE, with a higher accuracy for the prediction of rectosigmoid compared with anterior rectal DIE. Although the sensitivity for vaginal and RVS DIE was limited, gel SVG had a high specificity and NPV for all forms of posterior DIE, indicating that a negative gel SVG examination is highly suggestive of the absence of DIE at laparoscopy. Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd.

  19. Efficacy of Mesoglycan in Pain Control after Excisional Hemorrhoidectomy: A Pilot Comparative Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Gaetano Gallo

    2018-01-01

    Full Text Available Introduction. Various pain management strategies for patients undergoing open excisional hemorrhoidectomy have been proposed, yet postoperative pain remains a frequent complaint. Objective. To determine whether mesoglycan (30 mg two vials i.m. once/day for the first 5 days postoperative, followed by 50 mg 1 oral tablet twice/day for 30 days would reduce the edema of the mucocutaneous bridges and thus improve postoperative pain symptoms. Patients and Methods. For this prospective observational multicenter study, 101 patients undergoing excisional diathermy hemorrhoidectomy for III-IV degree hemorrhoidal disease were enrolled at 5 colorectal referral centers. Patients were assigned to receive either mesoglycan (study group SG or a recommended oral dose of ketorolac tromethamine of 10 mg every 4–6 hours, not exceeding 40 mg per day and not exceeding 5 postoperative days according to the indications for short-term management of moderate/severe acute postoperative pain, plus stool softeners (control group CG. Results. Postoperative thrombosis (SG 1/48 versus CG 5/45 (p<0.001 and pain after rectal examination (p<0.001 were significantly reduced at 7–10 days after surgery in the mesoglycan-treated group, permitting a faster return to work (p<0.001; however, in the same group, the incidence of postoperative bleeding, considered relevant when needing a readmission or an unexpected outpatient visit, was higher, possibly owing to the drug’s antithrombotic properties. Conclusions. The administration of mesoglycan after an open diathermy excisional hemorrhoidectomy can reduce postoperative thrombosis and pain at 7–10 days after surgery, permitting a faster return to normal activities.

  20. Multicenter prospective study of magnetic resonance imaging prior to breast-conserving surgery for breast cancer.

    Science.gov (United States)

    Liu, Qian; Liu, Yinhua; Xu, Ling; Duan, Xuening; Li, Ting; Qin, Naishan; Kang, Hua; Jiang, Hongchuan; Yang, Deqi; Qu, Xiang; Jiang, Zefei; Yu, Chengze

    2014-01-01

    This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer. The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012. The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group). Enhanced MRI was used to measure breast volume, longest diameter of tumor and tumor volume. The correlations between these measurements and those derived from histopathologic findings were assessed. The relationships between the success rate of breast-conserving surgery and MRI- and pathology-based measurement results were statistically analyzed in the breast-conserving group. The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group. Allocation to these groups was based on clinical indications and patient preferences. The cut-off for concurrence between MRI- and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm. In the total mastectomy group, the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%. Correlation coefficients for MRI and histopathology-based measurements of breast volume, tumor volume and tumor volume/breast volume ratio were r = 0.861, 0.569, and 0.600, respectively (all P surgery were 100% and 88.54%, respectively. There were significant correlations between dynamic enhanced MRI- and histopathology-based measurements of the longest diameter of breast lesions, breast and tumor volumes, and breast volume/tumor volume ratios. Preoperative MRI examination improves the success rate of breast-conserving surgery.

  1. Aggressive Surgical Management of Congenital Diaphragmatic Hernia: Worth the Effort?: A Multicenter, Prospective, Cohort Study.

    Science.gov (United States)

    Harting, Matthew T; Hollinger, Laura; Tsao, Kuojen; Putnam, Luke R; Wilson, Jay M; Hirschl, Ronald B; Skarsgard, Erik D; Tibboel, Dick; Brindle, Mary E; Lally, Pamela A; Miller, Charles C; Lally, Kevin P

    2018-05-01

    The objectives of this study were (i) to evaluate infants with congenital diaphragmatic hernia (CDH) that do not undergo repair, (ii) to identify nonrepair rate by institution, and (iii) to compare institutional outcomes based on nonrepair rate. Approximately 20% of infants with CDH go unrepaired and the threshold to offer surgical repair is variable. Data were abstracted from a multicenter, prospectively collected database. Standard clinical variables, including repair (or nonrepair), and outcome were analyzed. Institutions were grouped based on volume and rate of nonrepair. Preoperative mortality predictors were identified using logistic regression, expected mortality for each center was calculated, and observed /expected (O/E) ratios were computed for center groups and compared by Kruskal-Wallis ANOVA. A total of 3965 infants with CDH were identified and 691 infants (17.5%) were not repaired. Nonrepaired patients had lower Apgar scores (P HiLo = 5.1-16.7% and HiHi = 17.6-38.5%), leaving 3 groups: HiLo, HiHi, and Lo. Predictors of mortality were lower birth weight, lower Apgar scores, prenatal diagnosis, and presence of congenital anomalies. O/E ratios for mortality in the HiLo, HiHi, and Lo groups were 0.81, 0.94, and 1.21, respectively (P HiLo centers have 2.73 (2.4-3.1, 95% confidence interval) survivors beyond expectation. There are significant differences between repaired and nonrepaired CDH infants and significant center variation in rate of nonrepair exists. Aggressive surgical management, leading to a low rate of nonrepair, is associated with improved risk-adjusted mortality.

  2. Next-generation narrow band imaging system for colonic polyp detection: a prospective multicenter randomized trial.

    Science.gov (United States)

    Horimatsu, Takahiro; Sano, Yasushi; Tanaka, Shinji; Kawamura, Takuji; Saito, Shoichi; Iwatate, Mineo; Oka, Shiro; Uno, Koji; Yoshimura, Kenichi; Ishikawa, Hideki; Muto, Manabu; Tajiri, Hisao

    2015-07-01

    Previous studies have yielded conflicting results on the colonic polyp detection rate with narrow-band imaging (NBI) compared with white-light imaging (WLI). We compared the mean number of colonic polyps detected per patient for NBI versus WLI using a next-generation NBI system (EVIS LUCERA ELITE; Olympus Medical Systems) used with standard-definition (SD) colonoscopy and wide-angle (WA) colonoscopy. this study is a 2 × 2 factorial, prospective, multicenter randomized controlled trial. this study was conducted at five academic centers in Japan. patients were allocated to one of four groups: (1) WLI with SD colonoscopy (H260AZI), (2) NBI with SD colonoscopy (H260AZI), (3) WLI with WA colonoscopy (CF-HQ290), and (4) NBI with WA colonoscopy (CF-HQ290). the mean numbers of polyps detected per patient were compared between the four groups: WLI with/without WA colonoscopy and NBI with/without WA colonoscopy. Of the 454 patients recruited, 431 patients were enrolled. The total numbers of polyps detected by WLI with SD, NBI with SD, WLI with WA, and NBI with WA were 164, 176, 188, and 241, respectively. The mean number of polyps detected per patient was significantly higher in the NBI group than in the WLI group (2.01 vs 1.56; P = 0.032). The rate was not higher in the WA group than in the SD group (1.97 vs 1.61; P = 0.089). Although WA colonoscopy did not improve the polyp detection, next-generation NBI colonoscopy represents a significant improvement in the detection of colonic polyps.

  3. Screening techniques to identify people at high risk for diabetic foot ulceration: a prospective multicenter trial.

    Science.gov (United States)

    Pham, H; Armstrong, D G; Harvey, C; Harkless, L B; Giurini, J M; Veves, A

    2000-05-01

    Diabetic foot ulceration is a preventable long-term complication of diabetes. A multicenter prospective follow-up study was conducted to determine which risk factors in foot screening have a high association with the development of foot ulceration. A total of 248 patients from 3 large diabetic foot centers were enrolled in a prospective study. Neuropathy symptom score, neuropathy disability score (NDS), vibration perception threshold (VPT), Semmes-Weinstein monofilaments (SWFs), joint mobility, peak plantar foot pressures, and vascular status were evaluated in all patients at the beginning of the study. Patients were followed-up every 6 months for a mean period of 30 months (range 6-40), and all new foot ulcers were recorded. The sensitivity, specificity, and positive predictive value of each risk factor were evaluated. Foot ulcers developed in 95 feet (19%) or 73 patients (29%) during the study. Patients who developed foot ulcers were more frequently men, had diabetes for a longer duration, had nonpalpable pedal pulses, had reduced joint mobility, had a high NDS, had a high VPT, and had an inability to feel a 5.07 SWE NDS alone had the best sensitivity, whereas the combination of the NDS and the inability to feel a 5.07 SWF reached a sensitivity of 99%. On the other hand, the best specificity for a single factor was offered by foot pressures, and the best combination was that of NDS and foot pressures. Univariate logistical regression analysis yielded a statistically significant odds ratio (OR) for sex, race, duration of diabetes, palpable pulses, history of foot ulceration, high NDSs, high VPTs, high SWFs, and high foot pressures. In addition, 94 (99%) of the 95 ulcerated feet had a high NDS and/or SWF which resulted in the highest OR of 26.2 (95% CI 3.6-190). Furthermore, in multivariate logistical regression analysis, the only significant factors were high NDSs, VPTs, SWFs, and foot pressures. Clinical examination and a 5.07 SWF test are the two most sensitive

  4. Comparative Study for Efficacy and Safety of Adenoidectomy according to the Surgical Method: A Prospective Multicenter Study.

    Directory of Open Access Journals (Sweden)

    Jeong-Whun Kim

    Full Text Available There have been several operative techniques for adenoidectomy and their efficacy and morbidity are different according to the technique. This prospective multicenter study was aimed to compare the efficacy and morbidity of coblation adenoidectomy (CA with those of power-assisted adenoidectomy.Prospective multi-institutional study.Children who underwent CA, power-assisted adenoidectomy with cauterization (PAA+C or without cauterization (PAA-C due to adenoid hypertrophy were enrolled from 13 hospitals between July 2013 and June 2014. Mean operation time, degree of intraoperative bleeding and postoperative bleeding rate were evaluated.A total of 388 children (mean age ± standard deviation = 6.6 ± 2.5 years; 245 males and 143 females were included. According to the adenoidectomy technique, the children were classified into 3 groups: (1 CA (n = 116; (2 PAA+C (n = 153; and (3 PAA-C (n = 119. Significant differences were not found in age and sex among three groups. In the CA group, mean operation time was significantly shorter (P < 0.001 and degree of intraoperative bleeding was significantly less (P < 0.001 compared to PAA+C or PAA-C group. Delayed postoperative bleeding rate of PAA-C group was significantly higher than that of CA or PAA+C group (P = 0.016.This prospective multicenter study showed that CA was superior to PAA in terms of mean operation time and degree of intraoperative bleeding.

  5. Determinants of developmental delay in infants aged 12 months.

    Science.gov (United States)

    Slykerman, Rebecca F; Thompson, John M D; Clark, Phillipa M; Becroft, David M O; Robinson, Elizabeth; Pryor, Jan E; Wild, Chris J; Mitchell, Edwin A

    2007-03-01

    The aim of this study was to determine which demographic, maternal, obstetric and postnatal variables were associated with achievement of developmental milestones at the age of 12 months in term infants. Mothers and babies were enrolled in the Auckland Birthweight Collaborative Study shortly after birth. All infants were full term (gestation >or= 37 weeks). Approximately half of the sample were small for gestational age (SGA = birthweight 10th percentile). A maternal interview was conducted soon after birth. Phase 2 of the study occurred 12 months later when mothers were sent a postal questionnaire requesting information about the child's health and development during the first year of life using the Denver Prescreening Developmental Questionnaire. Seven hundred and forty-four (85.4%) European mothers returned the postal questionnaire. SGA children were not at increased risk of developmental delay at 12 months of age. In a sample representative of New Zealand European children, after adjustment for the effects of potential confounders, maternal smoking during pregnancy (OR = 2.1 [95% CI 1.1, 4.0]), maternal smoking during the first year of life (OR = 1.9 [95% CI 1.0, 3.8]) and low levels of satisfaction with parenting (OR = 2.4 [95% CI 1.1, 5.2]) were associated with significantly increased risk of developmental delay. In the subgroup of SGA children, maternal smoking during pregnancy (OR = 2.9 [95% CI 1.4, 6.2]), high levels of stress associated with parenting (OR = 2.2 [95% CI 1.2, 4.0]), and low levels of satisfaction with parenting (OR = 4.3 [95% CI 1.3, 13.5]) were significantly associated with developmental delay after adjustment for the effects of potential confounders. In conclusion, maternal and postnatal factors were better predictors of developmental delay than demographic variables.

  6. Maternal antenatal depression and infant disorganized attachment at 12 months.

    Science.gov (United States)

    Hayes, Lisa J; Goodman, Sherryl H; Carlson, Elizabeth

    2013-01-01

    Although high rates of attachment disorganization have been observed in infants of depressed mothers, little is known about the role of antenatal depression as a precursor to infant attachment disorganization. The primary aim of this study was to examine associations between maternal antenatal depression and infant disorganization at 12 months in a sample of women (N = 79) at risk for perinatal depression. A secondary aim was to test the roles of maternal postpartum depression and maternal parenting quality as potential moderators of this predicted association. Among women with histories of major depressive episodes, maternal depressive symptoms were assessed at multiple times during pregnancy and the first year postpartum, maternal parenting quality was measured at three months postpartum, and attachment disorganization was assessed at 12 months postpartum. Results revealed that infants classified as disorganized had mothers with higher levels of depressive symptoms during pregnancy compared to infants classified as organized. Maternal parenting quality moderated this association, as exposure to higher levels of maternal depressive symptoms during pregnancy was only associated with higher rates of infant disorganized attachment when maternal parenting at three months was less optimal. These findings suggest that enhancing maternal parenting behaviors during this early period in development has the potential to alter pathways to disorganized attachment among infants exposed to antenatal maternal depressive symptoms, which could have enduring consequences for child wellbeing.

  7. A Prospective, Multicentered Study to Assess Social Adjustment in Patients With an Intestinal Stoma in Turkey.

    Science.gov (United States)

    Karadağ, Ayişe; Karabulut, Hatice; Baykara, Zehra G; Harputlu, Deniz; Toyluk, Eylem; Ulusoy, Birgül; Karadağ, Sercan; Kahraman, Aysel; Hin, Aysel Ören; Altinsoy, Meral; Akıl, Yasemin; Leventoğlu, Sezai

    2015-10-01

    Patients with a stoma undergo physiological, psychological, and social adjustment to their new life situation. A descriptive, prospective study was conducted to assess adaptation among patients >18 years of age with a new temporary or permanent colostomy or ileostomy living in Turkey and receiving care at a participating stomatherapy unit. The study took place between September 1, 2011, and September 1, 2012. During hospitalization and following discharge, patients with a stoma received training and counseling according to their individual characteristics and their physiological, psychological, and social needs. Each participant completed the 19-item "Identification Form for Patients with a Stoma" at the beginning of the study to document sociodemographic and stoma characteristics. To assess adjustment to the stoma, The Ostomy Assessment Inventory (OAI-23) was administered 2 times - the first within 1 month and the second within 6 months after surgery or when a temporary stoma was closed (whichever came first). This instrument comprised 23 items regarding adaptation to the stoma using Likert-type response options (0-4 range). Total scores ranged from 10 to 92, with higher scores indicating better adjustment. The instruments were completed by stoma and wound care nurses during face-to-face interviews. Data were analyzed using the Kruskal-Wallis, Mann-Whitney, and Wilcoxon tests. Of the 135 participants, the majority (77, 57.0%) were male; 73 (54.1%) had a colostomy, and 106 (78.5%) had a temporary stoma. The primary reason for stoma creation was cancer (89, 65.9%). Mean total OAI-23 scores were 48.63 ± 13.75 at the first administration and 50.59 ± 13.89 for the second. In terms of sociodemographic factors, significant increases in mean scores from the first to the second survey time were noted among patients in the 50-69 age group, women, married persons, and unemployed persons (P less than 0.05). With regard to stoma characteristics, the OAI-23 scores of patients

  8. Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

    Directory of Open Access Journals (Sweden)

    Bockelbrink Angelina

    2010-07-01

    Full Text Available Abstract Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female were included. The most frequent diagnoses were hypertension (11.1%, breast cancer (3.5%, and heart failure (3.0%. In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic. The adjusted odds ratio (AOR for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79, treatment by an internist (AOR = 1.49; CI: 1.40-1.58, female patients (AOR = 1.35; CI: 1.27-1.43, cancer (AOR = 4.54; CI: 4.12-4.99, arthropathies (AOR = 1.36; CI: 1.19-1.55, or dorsopathies (AOR = 1.34; CI: 1.16-1.55 and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98. The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39, diabetes mellitus (AOR = 0.17; CI: 0

  9. Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Gianni Imperiali

    2017-01-01

    Full Text Available Background. Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although it is limited by costs and variability of results. Aim. To assess effectiveness of granulocyte-monocyte apheresis in patients with steroid-dependent, azathioprine-intolerant/resistant moderate ulcerative colitis. Methods. Consecutive patients fulfilling inclusion criteria were prospectively enrolled, treated by apheresis, and followed up for 12 months. The primary end point of the study was steroid-free clinical remission at 12 months, with no need for biologic therapy or surgery. Results. From January to December 2013, 33 patients were enrolled. After one year of follow-up, 12 (36% patients had clinical remission, were steroid-free, and had no need for biological therapy or surgery; 3 (9% cases showed a clinical response (but not clinical remission. Moreover, 12 (36% patients required biologic therapy, 4 (12% underwent colectomy, and in the other 2 (6% a reduction, but not withdrawal, of steroid dose was achieved. Conclusions. Our study shows that a standard course of granulocyte-monocyte apheresis is associated with a 36% steroid-free clinical remission in patients with steroid-dependent, azathioprine-intolerant or resistant moderate ulcerative colitis. Apheresis might represent an alternative to biologic therapy or surgery in this specific subgroup of patients. This trial is registered with Clinicaltrial.gov NCT03189888.

  10. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    Energy Technology Data Exchange (ETDEWEB)

    Zaknun, John J. [University Hospital of Innsbruck, Department of Nuclear Medicine, Innsbruck (Austria); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria); IAEA, Nuclear Medicine Section, Division of Human Health, Wagramer Strasse 5, P.O. Box 100, Wien (Austria); Bal, Chandrasekhar [All India Institute of Medical Sciences, Department of Nuclear Medicine, New Delhi (India); Maes, Alex [Katholieke Universiteit Leuven, Leuven (Belgium); AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); Tepmongkol, Supatporn [Chulalongkorn University, Nuclear Medicine Division, Department of Radiology, Bangkok (Thailand); Vazquez, Silvia [Instituto de Investigaciones Neurologicas, FLENI, Department of Radiology, Buenos Aires (Argentina); Dupont, Patrick [Katholieke Universiteit Leuven, Leuven (Belgium); Dondi, Maurizio [Ospedale Maggiore, Department of Nuclear Medicine, Bologna (Italy); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria)

    2008-01-15

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  11. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    International Nuclear Information System (INIS)

    Zaknun, John J.; Bal, Chandrasekhar; Maes, Alex; Tepmongkol, Supatporn; Vazquez, Silvia; Dupont, Patrick; Dondi, Maurizio

    2008-01-01

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  12. Impact of malnutrition on 12-month mortality following acute hip fracture.

    Science.gov (United States)

    Bell, Jack J; Pulle, Ranjeev C; Crouch, Alisa M; Kuys, Suzanne S; Ferrier, Rebecca L; Whitehouse, Sarah L

    2016-03-01

    Studies investigating the relationship between malnutrition and post-discharge mortality following acute hip fracture yield conflicting results. This study aimed to determine whether malnutrition independently predicted 12-month post-fracture mortality after adjusting for clinically relevant covariates. An ethics approved, prospective, consecutive audit was undertaken for all surgically treated hip fracture inpatients admitted to a dedicated orthogeriatric unit (November 2010-October 2011). The 12-month mortality data were obtained by a dual search of the mortality registry and Queensland Health database. Malnutrition was evaluated using the Subjective Global Assessment. Demographic (age, gender, admission residence) and clinical covariates included fracture type, time to surgery, anaesthesia type, type of surgery, post-surgery time to mobilize and post-operative complications (delirium, pulmonary and deep vein thrombosis, cardiac complications, infections). The Charlson Comorbidity Index was retrospectively applied. All diagnoses were confirmed by the treating orthogeriatrician. A total of 322 of 346 patients were available for audit. Increased age (P = 0.004), admission from residential care (P malnutrition (P 48 h (P malnutrition (odds ratio (OR) 2.4 (95% confidence interval (CI) 1.3-4.7, P = 0.007)), in addition to admission from residential care (OR 2.6 (95% CI 1.3-5.3, P = 0.005)) and pulmonary embolism (OR 11.0 (95% CI 1.5-78.7, P = 0.017)), independently predicted 12-month mortality. Findings substantiate malnutrition as an independent predictor of 12-month mortality in a representative sample of hip fracture inpatients. Effective strategies to identify and treat malnutrition in hip fracture should be prioritized. © 2016 Royal Australasian College of Surgeons.

  13. Prevalence, incidence and course of lower extremity injuries in runners during a 12-month follow-up period

    NARCIS (Netherlands)

    Poppel van, D.; Scholten-Peeters, G G M; van Middelkoop, M.; Verhagen, Arianne P

    2014-01-01

    To describe the incidence, 12-month prevalence, and course of lower extremity injuries that occurred during and after the Amgen Singelloop Breda in 2009. The design was based on a prospective cohort study with a population-based setting. In total, 3605 registered runners received a web-based

  14. Impact of lenalidomide-based induction therapy on the mobilization of CD34+ cells, blood graft cellular composition, and post-transplant recovery in myeloma patients: a prospective multicenter study.

    Science.gov (United States)

    Partanen, Anu; Valtola, Jaakko; Silvennoinen, Raija; Ropponen, Antti; Siitonen, Timo; Putkonen, Mervi; Sankelo, Marja; Pelkonen, Jukka; Mäntymaa, Pentti; Varmavuo, Ville; Jantunen, Esa

    2017-10-01

    Lenalidomide is an immunomodulatory drug that is also currently used in transplant-eligible patients with multiple myeloma. Previous studies have suggested a negative impact of lenalidomide on the mobilization of CD34 + cells. No data are available regarding the more detailed composition of blood grafts after lenalidomide. In a multicenter, prospective study, we analyzed the mobilization of CD34 + cells, graft cellular composition, and post-transplant hematologic recovery in 26 patients with multiple myeloma after lenalidomide-based induction and in 34 lenalidomide-naive controls with multiple myeloma. All patients were mobilized with low-dose cyclophosphamide plus granulocyte-colony-stimulating factor. The cellular composition of the grafts was analyzed from thawed, cryopreserved samples with flow cytometry. Graft function was evaluated by engraftment data and by complete blood counts until 12 months after the graft infusion. Patients in the lenalidomide arm had lower median peak CD34 + counts and approximately 40% lower CD34 + cell yields from the first apheresis session, but these differences were not significant. The median total number of CD34 + cells collected was comparable (6.4 vs. 7.5 × 10 6 /kg). The number of apheresis sessions was higher in the lenalidomide group (2 vs. 1; p = 0.039). The blood graft composition was comparable between the groups. Hematologic recovery within 12 months post-transplant did not differ between the groups. Lenalidomide-based induction seems to have an impact on the number of aphereses performed, but not on the total yields of the CD34 + cells in the graft. Neither cellular composition of the grafts nor post-transplant recovery was affected by the limited pre-transplant exposure to lenalidomide. © 2017 AABB.

  15. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

    Science.gov (United States)

    Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

    2016-02-08

    This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  16. Sympathetic Response and Outcomes Following Renal Denervation in Patients With Chronic Heart Failure: 12-Month Outcomes From the Symplicity HF Feasibility Study.

    Science.gov (United States)

    Hopper, Ingrid; Gronda, Edoardo; Hoppe, Uta C; Rundqvist, Bengt; Marwick, Thomas H; Shetty, Sharad; Hayward, Christopher; Lambert, Thomas; Hering, Dagmara; Esler, Murray; Schlaich, Markus; Walton, Antony; Airoldi, Flavio; Brandt, Mathias C; Cohen, Sidney A; Reiters, Pascalle; Krum, Henry

    2017-09-01

    Heart failure (HF) is associated with chronic sympathetic activation. Renal denervation (RDN) aims to reduce sympathetic activity by ablating the renal sympathetic nerves. We investigated the effect of RDN in patients with chronic HF and concurrent renal dysfunction in a prospective, multicenter, single-arm feasibility study. Thirty-nine patients with chronic systolic HF (left ventricular ejection fraction [LVEF] renal impairment (estimated glomerular filtration rate [eGFR; assessed with the use of the Modification of Diet in Renal Disease equation] renal artery occlusion that was possibly related to the denervation procedure. Statistically significant reductions in N-terminal pro-B-type natriuretic peptide (NT-proBNP; 1530 ± 1228 vs 1428 ± 1844 ng/mL; P = .006) and 120-minute glucose tolerance test (11.2 ± 5.1 vs 9.9 ± 3.6; P = .026) were seen at 12 months, but there was no significant change in LVEF (28 ± 9% vs 29 ± 11%; P= .536), 6-minute walk test (384 ± 96 vs 391 ± 97 m; P= .584), or eGFR (52.6 ± 15.3 vs 52.3 ± 18.5 mL • min -1  • 1.73 m -2 ; P= .700). RDN was associated with reductions in NT-proBNP and 120-minute glucose tolerance test in HF patients 12 months after RDN treatment. There was no deterioration in other indices of cardiac and renal function in this small feasibility study. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Kristen Meldi Plasseraud

    2016-01-01

    Full Text Available Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p=0.003 with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher’s exact test p=2.1×10-13 and p=0.04, resp.. The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920.

  18. Assessing early communication skills at 12 months: a retrospective study of Autism Spectrum Disorder.

    Science.gov (United States)

    Swain, Nathaniel Robert; Eadie, Patricia Ann; Prior, Margot Ruth; Reilly, Sheena

    2015-07-01

    Early identification of Autism Spectrum Disorder (ASD) is currently limited by the absence of reliable biological markers for the disorder, as well as the reliability of screening and assessment tools for children aged between 6 and 18 months. Ongoing research has demonstrated the importance of early social communication skills in differentiating children later diagnosed with ASD from their typically developing (TD) peers, but researchers have not yet investigated whether these differences can be detected using community-ascertained systematic observation data as early as 12 months. To investigate whether differences in early social communication skills can be detected at 12 months of age, comparing children later diagnosed with ASD, and TD peers; and to determine whether differences remain when groupings are based on age of subsequent ASD diagnosis. From a prospective community-ascertained sample, we collected data on children in early life, then conducted retrospective analyses for those children who were later diagnosed with ASD by the age of 7 years, compared with matched TD peers. We analysed standardized observational data of early communication skills, collected using the Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP) Behavior Sample, when participants were 12 months of age. Children in the ASD group exhibited significantly lower social communication skills than the TD group, including on the Total score and Social and Symbolic Composite scores of the CSBS-DP Behavior Sample. Differences on the Total score and Social Composite were also detected for both early and late ASD diagnosis groups when compared with the TD group. These findings give further support for the importance of social communication in assessing children at risk of ASD as early as 12 months of age. Future research could evaluate the sensitivity and specificity of direct observation of these early communication skills as diagnostic indicators for ASD at 12 months

  19. A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch

    DEFF Research Database (Denmark)

    Berrevoet, Frederik; Doerhoff, Carl; Muysoms, Filip

    2017-01-01

    PURPOSE: This study assessed the recurrence rate and other safety and efficacy parameters following ventral hernia repair with a polyester composite prosthesis (Parietex™ Composite Ventral Patch [PCO-VP]). PATIENTS AND METHODS: A single-arm, multicenter prospective study of 126 patients undergoing...

  20. The steroids for corneal ulcers trial (SCUT): secondary 12-month clinical outcomes of a randomized controlled trial.

    Science.gov (United States)

    Srinivasan, Muthiah; Mascarenhas, Jeena; Rajaraman, Revathi; Ravindran, Meenakshi; Lalitha, Prajna; O'Brien, Kieran S; Glidden, David V; Ray, Kathryn J; Oldenburg, Catherine E; Zegans, Michael E; Whitcher, John P; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R

    2014-02-01

    To determine whether topical corticosteroids as adjunctive therapy for bacterial keratitis improves long-term clinical outcomes. Randomized, placebo-controlled, double-masked clinical trial. This multicenter trial compared 1.0% prednisolone sodium phosphate to placebo in the treatment of bacterial keratitis among 500 patients with culture-positive ulcers receiving 48 hours of moxifloxacin before randomization. The primary endpoint was 3 months from enrollment, and 399 patients were evaluated at 12 months. The outcomes examined were best spectacle-corrected visual acuity (BSCVA) and scar size at 12 months. Based on previous results, regression models with adjustments for baseline status and/or causative organism were used for analysis. No significant differences in clinical outcomes by treatment group were seen with the prespecified regression models (BSCVA: -0.04 logMAR, 95% CI, -0.12 to 0.05, P = .39; scar size: 0.03 mm, 95% CI, -0.12 to 0.18, P = .69). A regression model including a Nocardia-treatment arm interaction found corticosteroid use associated with a mean 1-line improvement in BSCVA at 12 months among patients with non-Nocardia ulcers (-0.10 logMAR, 95% CI, -0.19 to -0.02, P = .02). No significant difference was observed in 12-month BSCVA for Nocardia ulcers (0.18 logMAR, 95% CI, -0.04 to 0.41, P = .16). Corticosteroids were associated with larger mean scar size at 12 months among Nocardia ulcers (0.47 mm, 95% CI, 0.06-0.88, P = .02) and no significant difference was identified by treatment for scar size for non-Nocardia ulcers (-0.06 mm, 95% CI, -0.21 to 0.10, P = .46). Adjunctive topical corticosteroid therapy may be associated with improved long-term clinical outcomes in bacterial corneal ulcers not caused by Nocardia species. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).

    Science.gov (United States)

    Matsushita, Hidenobu; Tanaka, Chie; Murotani, Kenta; Misawa, Kazunari; Ito, Seiji; Ito, Yuichi; Kanda, Mitsuro; Mochizuki, Yoshinari; Ishigure, Kiyoshi; Yaguchi, Toyohisa; Teramoto, Jin; Nakayama, Hiroshi; Kawase, Yoshihisa; Fujiwara, Michitaka; Kodera, Yasuhiro

    2018-01-01

    Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC. © 2017 S. Karger AG, Basel.

  2. A multicenter prospective study to assess the effect of early cleavage on embryo quality, implantation, and live-birth rate.

    Science.gov (United States)

    de los Santos, Maria José; Arroyo, Gemma; Busquet, Ana; Calderón, Gloria; Cuadros, Jorge; Hurtado de Mendoza, Maria Victoria; Moragas, Marta; Herrer, Raquel; Ortiz, Agueda; Pons, Carme; Ten, Jorge; Vilches, Miguel Angel; Figueroa, Maria José

    2014-04-01

    To investigate the impact of early cleavage (EC) on embryo quality, implantation, and live-birth rates. Prospective cross-sectional study. Multicenter study. Seven hundred embryo transfers and 1,028 early-stage human embryos. None. Implantation according to the presence of EC and embryo quality. The presence of EC is associated with embryo quality, especially in cycles with autologous oocytes. However, the use of EC as an additional criterion for selecting an embryo for transfer does not appear to significantly improve likelihood of implantation. Furthermore, embryos that presented EC had live-birth rates per implanted embryo similar to those that did not show any sign of cleavage. At least for conventional embryo culture and morphologic evaluations, the additional evaluation of EC in embryos may not be valuable to improve embryo implantation. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  3. Moderate Traumatic Brain Injury: Clinical Characteristics and a Prognostic Model of 12-Month Outcome.

    Science.gov (United States)

    Einarsen, Cathrine Elisabeth; van der Naalt, Joukje; Jacobs, Bram; Follestad, Turid; Moen, Kent Gøran; Vik, Anne; Håberg, Asta Kristine; Skandsen, Toril

    2018-03-31

    Patients with moderate traumatic brain injury (TBI) often are studied together with patients with severe TBI, even though the expected outcome of the former is better. Therefore, we aimed to describe patient characteristics and 12-month outcomes, and to develop a prognostic model based on admission data, specifically for patients with moderate TBI. Patients with Glasgow Coma Scale scores of 9-13 and age ≥16 years were prospectively enrolled in 2 level I trauma centers in Europe. Glasgow Outcome Scale Extended (GOSE) score was assessed at 12 months. A prognostic model predicting moderate disability or worse (GOSE score ≤6), as opposed to a good recovery, was fitted by penalized regression. Model performance was evaluated by area under the curve of the receiver operating characteristics curves. Of the 395 enrolled patients, 81% had intracranial lesions on head computed tomography, and 71% were admitted to an intensive care unit. At 12 months, 44% were moderately disabled or worse (GOSE score ≤6), whereas 8% were severely disabled and 6% died (GOSE score ≤4). Older age, lower Glasgow Coma Scale score, no day-of-injury alcohol intoxication, presence of a subdural hematoma, occurrence of hypoxia and/or hypotension, and preinjury disability were significant predictors of GOSE score ≤6 (area under the curve = 0.80). Patients with moderate TBI exhibit characteristics of significant brain injury. Although few patients died or experienced severe disability, 44% did not experience good recovery, indicating that follow-up is needed. The model is a first step in development of prognostic models for moderate TBI that are valid across centers. Copyright © 2018 The Author(s). Published by Elsevier Inc. All rights reserved.

  4. Sentinel node mapping for gastric cancer: a prospective multicenter trial in Japan.

    Science.gov (United States)

    Kitagawa, Yuko; Takeuchi, Hiroya; Takagi, Yu; Natsugoe, Shoji; Terashima, Masanori; Murakami, Nozomu; Fujimura, Takashi; Tsujimoto, Hironori; Hayashi, Hideki; Yoshimizu, Nobunari; Takagane, Akinori; Mohri, Yasuhiko; Nabeshima, Kazuhito; Uenosono, Yoshikazu; Kinami, Shinichi; Sakamoto, Junichi; Morita, Satoshi; Aikou, Takashi; Miwa, Koichi; Kitajima, Masaki

    2013-10-10

    Complicated gastric lymphatic drainage potentially undermines the utility of sentinel node (SN) biopsy in patients with gastric cancer. Encouraged by several favorable single-institution reports, we conducted a multicenter, single-arm, phase II study of SN mapping that used a standardized dual tracer endoscopic injection technique. Patients with previously untreated cT1 or cT2 gastric adenocarcinomas 4 cm. We observed no serious adverse effects related to endoscopic tracer injection or the SN mapping procedure. The endoscopic dual tracer method for SN biopsy was confirmed as safe and effective when applied to the superficial, relatively small gastric adenocarcinomas included in this study.

  5. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC.

    Science.gov (United States)

    Sekulic, Aleksandar; Migden, Michael R; Lewis, Karl; Hainsworth, John D; Solomon, James A; Yoo, Simon; Arron, Sarah T; Friedlander, Philip A; Marmur, Ellen; Rudin, Charles M; Chang, Anne Lynn S; Dirix, Luc; Hou, Jeannie; Yue, Huibin; Hauschild, Axel

    2015-06-01

    Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. An efficacy and safety analysis was conducted 12 months after primary analysis. This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  6. Micropulse diode laser trabeculoplasty (MDLT: A phase II clinical study with 12 months follow-up

    Directory of Open Access Journals (Sweden)

    Antonio Maria Fea

    2008-06-01

    Full Text Available Antonio Maria Fea, Alex Bosone, Teresa Rolle, Beatrice Brogliatti, Federico Maria GrignoloIstituto di Fisiopatologia Clinica, Clinica Oculistica dell’ Università di Torino, Torino, ItalyObjective: This pilot study evaluates the pressure lowering potential of subthreshold micropulse diode laser trabeculoplasty (MDLT for a clinically meaningful duration in patients with medically uncontrolled open angle glaucoma (OAG.Design: prospective interventional case series.Participants: Thirty-two eyes of 20 consecutive patients with uncontrolled OAG (12 bilateral and 8 unilateral.Methods: Confluent subthreshold laser applications over the inferior 180° of the anterior TM using an 810 nm diode laser in a micropulse operating mode. The intraocular pressure (IOP was measured at baseline and at 1 hour, 1 day, 1 week, 3, 6, 9, and 12 months post-treatment. Flare was measured with a Kowa FM 500 flare-meter at baseline and at 3 hours, 1 day, 1 week, and 12 months post-treatment. After treatment, the patients were maintained on their pre-treatment drug regimen.Main outcome measures: Criteria for treatment response were IOP reduction ≥3 mm Hg and IOP ≤21 mm Hg within the first week after MDLT. Eyes not complying to the above criteria during the follow-up were considered treatment failure. Mean IOP change and percentage of IOP reduction during the follow-up were calculated.Results: One eye was analyzed for bilateral patients. A total of 20 eyes were thus included. Four eyes (20% did not respond to treatment during the first week. One additional eye failed at the 6 month visit. The treatment was successful in 15 eyes (75% at 12 months. The IOP was significantly lower throughout follow-up (p < 0.01. At 12 months, the mean percentage of IOP reduction in the 15 respondent eyes was 22.1% and 12 eyes (60% had IOP reduction higher than 20%. During the first two postoperative days, one eye with pigmentary glaucoma experienced a significant increase of flare

  7. Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

    Science.gov (United States)

    Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

    2012-01-01

    The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

  8. Diagnostic and prognostic stratification in the emergency department using urinary biomarkers of nephron damage: a multicenter prospective cohort study.

    Science.gov (United States)

    Nickolas, Thomas L; Schmidt-Ott, Kai M; Canetta, Pietro; Forster, Catherine; Singer, Eugenia; Sise, Meghan; Elger, Antje; Maarouf, Omar; Sola-Del Valle, David Antonio; O'Rourke, Matthew; Sherman, Evan; Lee, Peter; Geara, Abdallah; Imus, Philip; Guddati, Achuta; Polland, Allison; Rahman, Wasiq; Elitok, Saban; Malik, Nasir; Giglio, James; El-Sayegh, Suzanne; Devarajan, Prasad; Hebbar, Sudarshan; Saggi, Subodh J; Hahn, Barry; Kettritz, Ralph; Luft, Friedrich C; Barasch, Jonathan

    2012-01-17

    This study aimed to determine the diagnostic and prognostic value of urinary biomarkers of intrinsic acute kidney injury (AKI) when patients were triaged in the emergency department. Intrinsic AKI is associated with nephron injury and results in poor clinical outcomes. Several urinary biomarkers have been proposed to detect and measure intrinsic AKI. In a multicenter prospective cohort study, 5 urinary biomarkers (urinary neutrophil gelatinase-associated lipocalin, kidney injury molecule-1, urinary liver-type fatty acid binding protein, urinary interleukin-18, and cystatin C) were measured in 1,635 unselected emergency department patients at the time of hospital admission. We determined whether the biomarkers diagnosed intrinsic AKI and predicted adverse outcomes during hospitalization. All biomarkers were elevated in intrinsic AKI, but urinary neutrophil gelatinase-associated lipocalin was most useful (81% specificity, 68% sensitivity at a 104-ng/ml cutoff) and predictive of the severity and duration of AKI. Intrinsic AKI was strongly associated with adverse in-hospital outcomes. Urinary neutrophil gelatinase-associated lipocalin and urinary kidney injury molecule 1 predicted a composite outcome of dialysis initiation or death during hospitalization, and both improved the net risk classification compared with conventional assessments. These biomarkers also identified a substantial subpopulation with low serum creatinine at hospital admission, but who were at risk of adverse events. Urinary biomarkers of nephron damage enable prospective diagnostic and prognostic stratification in the emergency department. Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  9. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

    Science.gov (United States)

    Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

    2012-05-01

    Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

  10. Good Functional Recovery of Complex Elbow Dislocations Treated With Hinged External Fixation: A Multicenter Prospective Study

    NARCIS (Netherlands)

    Iordens, Gijs I. T.; den Hartog, Dennis; van Lieshout, Esther M. M.; Tuinebreijer, Wim E.; de Haan, Jeroen; Patka, Peter; Verhofstad, Michael H. J.; Schep, Niels W. L.; Bronkhorst, M. W. G. A.; de Vries, M. R.; Goslings, J. C.; Rhemrev, S. J.; Roukema, G. R.; van der Meulen, H. G. W. M.; Verleisdonk, E. J. M. M.; Vroemen, J. P. A. M.; Wittich, Ph

    2015-01-01

    After a complex dislocation, some elbows remain unstable after closed reduction or fracture treatment. Function after treatment with a hinged external fixator theoretically allows collateral ligaments to heal without surgical reconstruction. However, there is a lack of prospective studies that

  11. Results of a Peripheral Cutting Balloon Prospective Multicenter European Registry in Hemodialysis Vascular Access

    International Nuclear Information System (INIS)

    Peregrin, Jan H.; Rocek, Miloslav

    2007-01-01

    Purpose. To report initial experience with the Peripheral Cutting Balloon (PCB) in treatment of failing hemodialysis shunts. Methods. A total of 190 patients (95 men, 95 women; average age 64.4 ± 11.9 years, range 32-87 years) who were treated with the PCB for pressure-resistant stenosis, restenosis or failed percutaneous transluminal angioplasty (PTA) in the venous limb of an arteriovenous shunt were followed in seven European centers using a simple registry. The group consisted of 109 de novo lesions (57%) and 79 restenotic lesions (43%). Results. Technical success was achieved in 88.9% of cases. Primary patency was as follows (the results for whole group and simultaneous results for de novo lesions and restenoses are presented): 1 month (140 patients followed): 94%, 98%, and 93%; 3 months (116 patients followed): 93%, 98%, and 92%; 6 months (40 patients followed): 85%, 92%, and 79%; 12 months (27 patients followed): 74%, 87%, and 48%. No complication occurred. Patients experienced an equal or lower level of pain during the procedure compared with conventional PTA. Conclusion. The PCB proved to be successful in dilating pressure-resistant stenoses. We cannot conclude whether PCB angioplasty can lower the restenosis rate in hemodialysis access lesions, but the long-term patency for de novo lesions is high. A further randomized study is advisable

  12. Correlation of serum KL-6 and CC16 levels with neurodevelopmental outcome in premature infants at 12 months corrected age

    Science.gov (United States)

    Zhang, Zhiqun; Lu, Hui; Zhu, Yunxia; Xiang, Junhua; Huang, Xianmei

    2015-01-01

    The aim of this study was to evaluate KL-6 and CC16 levels and their correlation with neurodevelopmental outcome among very low birth weight pre-term infants at 12 months corrected age. This prospective cohort study was performed from 2011 to 2013 by enrolling pre-term neonates of gestational age ≤ 32 weeks and birth weight ≤ 1500 g. Serum KL-6 and CC16 levels were determined 7 days after birth and their correlation with neurodevelopment was evaluated using Gesell Mental Developmental Scales. Of the 86 eligible pre-term infants, 63 completed follow-up, of which 15 had bronchopulmonary dysplasia. At 12 months corrected age, 49 infants had favorable outcomes and 14 infants had poor neurodevelopmental outcome. KL-6 levels were higher and CC16 levels were lower in infants with poor neurodevelopmental outcome compared with those infants who had favourable neurodevelopmental outcome. Serum KL-6 levels less than 90.0 ng/ml and CC16 levels greater than 320.0 pg/ml at 7 days of life were found to be predictive of a favourable outcome at 12 months corrected age. These biological markers could predict neurodevelopmental outcome at 12 months corrected age in very low birth weight premature infants, and help the clinician plan early therapeutic interventions to minimize or avoid poor neurodevelopmental outcome. PMID:25631862

  13. Hemorrhoid laser procedure for second- and third-degree hemorrhoids: results from a multicenter prospective study.

    Science.gov (United States)

    De Nardi, P; Tamburini, A M; Gazzetta, P G; Lemma, M; Pascariello, A; Asteria, C R

    2016-07-01

    The aim of our study was to assess the outcome of hemorrhoidal dearterialization, achieved by a dedicated laser energy device. From November 2012 to December 2014, 51 patients with second- or third-degree hemorrhoids were studied. The primary end point was a reduction in the bleeding rate; secondary end points were: postoperative complications, reduction in pain and prolapse, resolution of symptoms, and degree of patient's perception of improvement. The procedure was carried out as 1-day surgery. A diode laser device was employed to seal the terminal branches of the hemorrhoidal arteries, detected by a Doppler-equipped proctoscope. Follow-up was scheduled at 1 and 4 weeks, 3, 12, and 24 months. The rate and degree of symptoms was assessed with a four-point verbal rating scale. The rate of subjective symptomatic improvement was also evaluated with the Patient Global Improvement (PGI) Scale. Mean bleeding and pain scores at baseline were 2 and 0.57. All the patients were discharged on the day of surgery. Postoperative complications were bleeding (n = 4) and external hemorrhoidal thrombosis (n = 4). Mean bleeding and pain scores at 3, 12, and 24 months were significatively reduced. After 24 months, complete resolution of bleeding was observed in 28/29 patients (96.7 %), resolution of pain in all patients, and resolution of the mucosal prolapse in 15/18 patients (76.9 %). At 12-month follow-up, 86.3 % of patients reported improvement with the PGI Scale. The hemorrhoid laser procedure was effective in improving bleeding and pain symptoms in patients with grade II and III hemorrhoids.

  14. Results of prospective multicenter study on heart failure on Campania Internal Medicine wards: the FASHION study

    Directory of Open Access Journals (Sweden)

    Fernando Gallucci

    2017-06-01

    Full Text Available Heart failure (HF is characterized by a high prevalence and hospitalization rate with considerable health and social impact; the knowledge of its epidemiological features remains the mainstay to assess adequacy of the health care needs. The aim of this study was to evaluate the prevalence of HF in Internal Medicine Units of the Campania region (Italy and patients’ characteristics. We recruited all patients with HF admitted between April 1 and June 30, 2014, in 23 Units of Internal Medicine: 975 patients (19.5% of 5000 admissions, 518 women and 457 men, mean age 76.9±9.9 (range 34-100 with 741 (76% older than 70 years. The mean age was higher in women than men; 35.8% of patients had atrial fibrillation, with higher prevalence in women than in men. Coronary artery disease represented the leading etiology while prevalence of non-ischemic heart failure was higher in women. New York Heart Association class was indicated in 926 patients. Left ventricular ejection fraction (LVEF was measured in 503 patients; 18.4% of patients had a severely reduced LVEF<35%, mostly men (P=0.0001 and 67.4% presented a LVEF>40%. At least one hospital admission in the previous 12 months was registered in 39.6% of patients. One, two and more than two relevant comorbidities were present in 8.6%, 24.7% and 64.8% of patients, respectively. Arterial hypertension and coronary artery disease were more frequent in female. In conclusion, advanced age and clinical complexity were the main characteristics of HF patients hospitalized in the Internal Medicine Units in Campania. Gender differences also emerged from the analysis of demographic parameters and etiopathogenetic features. Some diagnostic and therapeutic aspects not in line with that recommended by the most recent HF international guidelines were registered.

  15. Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study.

    Science.gov (United States)

    Westera, Liset; van Viegen, Tanja; Jeyarajah, Jenny; Azad, Azar; Bilsborough, Janine; van den Brink, Gijs R; Cremer, Jonathan; Danese, Silvio; D'Haens, Geert; Eckmann, Lars; Faubion, William; Filice, Melissa; Korf, Hannelie; McGovern, Dermot; Panes, Julian; Salas, Azucena; Sandborn, William J; Silverberg, Mark S; Smith, Michelle I; Vermeire, Severine; Vetrano, Stefania; Shackelton, Lisa M; Stitt, Larry; Jairath, Vipul; Levesque, Barrett G; Spencer, David M; Feagan, Brian G; Vande Casteele, Niels

    2017-11-02

    Flow cytometry (FC) aids in characterization of cellular and molecular factors involved in pathologic immune responses. Although FC has potential to facilitate early drug development in inflammatory bowel disease, interlaboratory variability limits its use in multicenter trials. Standardization of methods may address this limitation. We compared variability in FC-aided quantitation of T-cell responses across international laboratories using three analytical strategies. Peripheral blood mononuclear cells (PBMCs) were isolated from three healthy donors, stimulated with phorbol 12-myristate 13-acetate and ionomycin at a central laboratory, fixed, frozen, and shipped to seven international laboratories. Permeabilization and staining was performed in triplicate at each laboratory using a common protocol and centrally provided reagents. Gating was performed using local gating with a local strategy (LGLS), local gating with a central strategy (LGCS), and central gating (CG). Median cell percentages were calculated across triplicates and donors, and reported for each condition and strategy. The coefficient of variation (CV) was calculated across laboratories. Between-strategy comparisons were made using a two-way analysis of variance adjusting for donor. Mean interlaboratory CV ranged from 1.8 to 102.1% depending on cell population and gating strategy (LGLS, 4.4-102.1%; LGCS, 10.9-65.6%; CG, 1.8-20.9%). Mean interlaboratory CV differed significantly across strategies and was consistently lower with CG. Central gating was the only strategy with mean CVs consistently lower than 25%, which is a proposed standard for pharmacodynamic and exploratory biomarker assays.

  16. Beta-blockers and depression after myocardial infarction - A multicenter prospective study

    NARCIS (Netherlands)

    van Melle, Joost P.; Verbeek, Danielle E. P.; van den Berg, Maarten P.; Ormel, Johan; van der Linde, Marcel R.; de Jonge, Peter

    2006-01-01

    OBJECTIVES The purpose of this research was to explore the prospective relationship between the use of beta-blockers and depression in myocardial infarction (MI) patients. BACKGROUND Beta-blocker use has been reported to be associated with the development of depression, but the methodological

  17. Laparoscopic sleeve gastrectomy in patients over 59 years: early recovery and 12-month follow-up.

    Science.gov (United States)

    Leivonen, Marja Kaarina; Juuti, Anne; Jaser, Nabil; Mustonen, Harri

    2011-08-01

    Bariatric surgery has shown to be safe for patients over 60 years with good results especially considering resolving of comorbidities. Sleeve gastrectomy is considered to be safer than gastric bypass (GBP) and more effective than gastric banding with less adverse symptoms. Weight loss may be more modest than after GBP, but the effect on vitamins may also be milder. Since 2007, we collected prospectively 12-month follow-up data from 55 sleeve gastrectomy patients of whom 12 were over 59 years of age. Vitamin and calcium supplements were used postoperatively. The recovery from the operation was recorded during hospital stay, at 1- and 12-month follow-up visits using a standard protocol including laboratory tests. The results between patients over and under 59 years were compared. The preoperative weight and weight loss were comparable between the groups. Operation time was shorter and hospital stay was longer for older patients, p = ns. There was no operative mortality. Early major complications were seen more often in the older age group, 42% vs 9% (p = 0.02), but late complications were more common in younger patients, 17% vs 44%, p = ns. Early complications were mostly bleedings, which did not lengthen the hospital stay, neither were re-operations nor endoscopic procedures needed. Excess weight loss and resolving of comorbidities after 12 months was comparable between the groups. However, vitamin deficiencies and hypoalbuminemia were more common in the older age group, 42% and 23% for vitamins and 44% and 29% for proteins, p = ns. The older patients had more adverse effects related to surgery, 25% vs 9%, and younger had more adverse psychiatric effects, p = ns. Sleeve gastrectomy is effective and safe for older bariatric patients. Weight loss is comparable to younger patients and enough to resolve the comorbidities in most of the patients. With standardized nutritional supplementation, the older patients had more often vitamin deficiencies and

  18. [The thermoformable spiral metallic stents in the treatment of localized ureteral stenosis: an alternative to JJ stent? Prospective multicenter study].

    Science.gov (United States)

    Bonniol, R; Meria, P; Safsaf, A; Albouy, B; Sibert, L

    2011-06-01

    Evaluation of the effectiveness and tolerance of thermoformable metallic spiral stents Memokath(®) 051 (Bard, Pnn Medical) in the treatment of localized ureteral stenosis in non-operable patients who have JJ ureteral stents. Prospective, descriptive and multicenter study of patients with ureteral strictures treated with metallic ureteral stents Memokath(®) 051. Assessment criteria (recurrent stenotic, permeability, tolerance) were measured by clinical, biological and radiological examination at 1 month, and then every 3 months. Fifteen stents (average length: 9.15 cm, range 6-15 cm) were implanted in 14 patients (mean age: 55 years, range: 38-72 years) with secondary suspended ureteral stenosis during 2 years in two centers. The median follow-up was 11 months (range 6 to 24 months). Technical difficulty was observed with two patients. Stents are still up in four patients. The stenosis recurred in four patients with spontaneous progression of stenosis but without endoprosthetics tissue invasion. Two and three migration were observed with spontaneous expulsions. Two lower urinary infections and one high occurred, resolved on antibiotic therapy, no inlay or hematuria, no pain (mean VAS score=3/10) or urinary disorders of the lower unit have been identified. Stents Memokath(®) 051 are well tolered and seem to position themselves as an interesting alternative to JJ ureteral stent in some frails patients. The refinement of contraindication should help to improve the stent's efficacity and to reduce the risk of migration and expulsion. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  19. How does social support affect functional impairment in late life? Findings of a multicenter prospective cohort study in Germany.

    Science.gov (United States)

    Hajek, André; Brettschneider, Christian; Mallon, Tina; van der Leeden, Carolin; Mamone, Silke; Wiese, Birgitt; Weyerer, Siegfried; Werle, Jochen; Fuchs, Angela; Pentzek, Michael; Riedel-Heller, Steffi G; Stein, Janine; Bickel, Horst; Weeg, Dagmar; Heser, Kathrin; Wagner, Michael; Maier, Wolfgang; Scherer, Martin; Luck, Tobias; König, Hans-Helmut

    2017-09-01

    to investigate how social support affects functional impairment (FI) in late life in a longitudinal approach. in a multicenter prospective cohort study, subjects in old age (≥75 years at baseline) were interviewed every 1.5 years. Social support was quantified in the follow-up (FU) Waves 2 and 4 (FU Wave 2: n = 2,349; FU Wave 4: n = 1,484). FI was assessed by using the Lawton and Brody Instrumental Activities of Daily Living scale. fixed effects regressions showed that a decrease in social support is associated with FI in the total sample and in both sexes. The effect on FI was most pronounced with the dimension social integration, whereas changes in practical support only affected FI in the total sample and changes in emotional support only affected FI in men. our findings emphasise the importance of social support for functional status in late life. Thus, strengthening social support in old age might be effective in maintaining functional abilities. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.All rights reserved. For permissions, please email: journals.permissions@oup.com

  20. One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial

    Science.gov (United States)

    Rastan, Aljoscha; McKinsey, James F.; Garcia, Lawrence A.; Rocha-Singh, Krishna J.; Jaff, Michael R.; Harlin, Stuart; Kamat, Suraj; Janzer, Sean; Zeller, Thomas

    2017-01-01

    Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound–defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients. PMID:29117818

  1. Outcome of the Respiratory Syncytial Virus related acute lower respiratory tract infection among hospitalized newborns: a prospective multicenter study.

    Science.gov (United States)

    Alan, Serdar; Erdeve, Omer; Cakir, Ufuk; Akduman, Hasan; Zenciroglu, Aysegul; Akcakus, Mustafa; Tunc, Turan; Gokmen, Zeynel; Ates, Can; Atasay, Begum; Arsan, Saadet

    2016-01-01

    To determine the incidence and outcomes of respiratory syncytial virus (RSV)-related acute lower respiratory tract infection (ALRI) including morbidity, nosocomial infection and mortality among newborn infants who were admitted to the neonatal intensive care units (NICUs). A multicenter, prospective study was conducted in newborns who were hospitalized with community acquired or nosocomial RSV infection in 44 NICUs throughout Turkey. Newborns with ALRI were screened for RSV infection by Respi-Strip®-test. Main outcome measures were the incidence of RSV-associated admissions in the NICUs and morbidity, mortality and epidemics results related to these admissions. The incidence of RSV infection was 1.24% (n: 250) and RSV infection constituted 19.6% of all ALRI hospitalizations, 226 newborns (90.4%) had community-acquired whereas 24 (9.6%) patients had nosocomial RSV infection in the NICUs. Of the 250 newborns, 171 (68.4%) were full-term infants, 183 (73.2%) had a BW >2500 g. RSV-related mortality rate was 1.2%. Four NICUs reported seven outbreaks on different months, which could be eliminated by palivizumab prophylaxis in one NICU. RSV-associated ALRI both in preterm and term infants accounts an important percent of hospitalizations in the season, and may threat other high-risk patients in the NICU.

  2. Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China.

    Science.gov (United States)

    He, Zhong; Chen, Rong; Zhou, Yingfang; Geng, Li; Zhang, Zhenyu; Chen, Shuling; Yao, Yanjun; Lu, Junli; Lin, Shouqing

    2009-05-20

    To investigate the efficacy and safety of VAC BNO 1095 extract in Chinese women suffering from moderate to severe premenstrual syndrome (PMS). Prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial design was employed. After screening and preparation phase lasting three cycles, Eligible patients were randomly assigned into treatment or placebo groups and had treatment with VAC extract or placebo for up to three cycles. Efficacy was assessed using the Chinese version PMS-diary (PMSD) and PMTS. Two hundred and seventeen women were eligible to enter the treatment phase (TP) and were randomly assigned into the treatment group (108) or the placebo group (109), 208 provided the efficacy data (treatment 104, placebo 104), and 202 completed the treatment phase (treatment 101, placebo 101). The mean total PMSD score decreased from 29.23 at baseline (0 cycle) to 6.41 at the termination (3rd cycle) for the treatment group and from 28.14 at baseline (0 cycle) to 12.64 at the termination (3rd cycle) for the placebo group. The total PMSD score of 3rd cycle was significantly lower than the baseline in both groups (pVitex agnus castus (VAC BNO 1095 corresponding to 40mg herbal drug) is a safe, well tolerated and effective drug of the treatment for Chinese women with the moderate to severe PMS.

  3. Treatment in carbon monoxide poisoning patients with headache: a prospective, multicenter, double-blind, controlled clinical trial.

    Science.gov (United States)

    Ocak, Tarik; Tekin, Erdal; Basturk, Mustafa; Duran, Arif; Serinken, Mustafa; Emet, Mucahit

    2016-11-01

    There is a lack of specificity of the analgesic agents used to treat headache and underlying acute carbon monoxide poisoning. To compare effectiveness of "oxygen alone" vs "metoclopramide plus oxygen" vs "metamizole plus oxygen" therapy in treating carbon monoxide-induced headache. A prospective, multicenter, double-blind, controlled trial. Three emergency departments in Turkey. Adult carbon monoxide poisoning patients with headache. A total of 117 carbon monoxide-intoxicated patients with headache were randomized into 3 groups and assessed at baseline, 30 minutes, 90 minutes, and 4 hours. The primary outcome was patient-reported improvement rates for headache. Secondary end points included nausea, need for rescue medication during treatment, and reduction in carboxyhemoglobin levels. During observation, there was no statistical difference between drug type and visual analog scale score change at 30 minutes, 90 minutes, or 4 hours, for either headache or nausea. No rescue medication was needed during the study period. The reduction in carboxyhemoglobin levels did not differ among the 3 groups. The use of "oxygen alone" is as efficacious as "oxygen plus metoclopramide" or "oxygen plus metamizole sodium" in the treatment of carbon monoxide-induced headache. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Recent effectiveness of proton pump inhibitors for severe reflux esophagitis: the first multicenter prospective study in Japan.

    Science.gov (United States)

    Mizuno, Hideki; Matsuhashi, Nobuyuki; Sakaguchi, Masahiro; Inoue, Syuji; Nakada, Koji; Higuchi, Kazuhide; Haruma, Ken; Joh, Takashi

    2015-11-01

    Proton pump inhibitors are the first-line treatment for reflux esophagitis. Because severe reflux esophagitis has very low prevalence in Japan, little is known about the effectiveness of proton pump inhibitors in these patients. This prospective multicenter study assessed the effectiveness of proton pump inhibitors for severe reflux esophagitis in Japan. Patients with modified Los Angeles grade C or D reflux esophagitis were treated with daily omeprazole (10 or 20 mg), lansoprazole (15 or 30 mg), or rabeprazole (10, 20, or 40 mg) for 8 weeks. Healing was assessed endoscopically, with questionnaires administered before and after treatment to measure the extent of reflux and dyspepsia symptoms. Factors affecting healing rates, including patient characteristics and endoscopic findings, were analyzed. Of the 115 patients enrolled, 64 with grade C and 19 with grade D reflux esophagitis completed the study. The healing rate was 67.5% (56/83), with 15 of the other 27 patients (55.6%) improving to grade A or B. No patient characteristic or endoscopic comorbidity was significantly associated with healing rate. Reflux and dyspepsia symptoms improved significantly with treatment. The low healing rate suggests the need of endoscopic examination to assess healing of reflux esophagitis at the end of therapy. (UMIN000005271).

  5. Laparoscopy in management of appendicitis in high-, middle-, and low-income countries: a multicenter, prospective, cohort study.

    Science.gov (United States)

    2018-04-05

    Appendicitis is the most common abdominal surgical emergency worldwide. Differences between high- and low-income settings in the availability of laparoscopic appendectomy, alternative management choices, and outcomes are poorly described. The aim was to identify variation in surgical management and outcomes of appendicitis within low-, middle-, and high-Human Development Index (HDI) countries worldwide. This is a multicenter, international prospective cohort study. Consecutive sampling of patients undergoing emergency appendectomy over 6 months was conducted. Follow-up lasted 30 days. 4546 patients from 52 countries underwent appendectomy (2499 high-, 1540 middle-, and 507 low-HDI groups). Surgical site infection (SSI) rates were higher in low-HDI (OR 2.57, 95% CI 1.33-4.99, p = 0.005) but not middle-HDI countries (OR 1.38, 95% CI 0.76-2.52, p = 0.291), compared with high-HDI countries after adjustment. A laparoscopic approach was common in high-HDI countries (1693/2499, 67.7%), but infrequent in low-HDI (41/507, 8.1%) and middle-HDI (132/1540, 8.6%) groups. After accounting for case-mix, laparoscopy was still associated with fewer overall complications (OR 0.55, 95% CI 0.42-0.71, p introduction, laparoscopy could significantly improve outcomes for patients in low-resource environments. NCT02179112.

  6. Point-of-care Beta-lactam Allergy Skin Testing by Antimicrobial Stewardship Programs: A Pragmatic Multicenter Prospective Evaluation.

    Science.gov (United States)

    Leis, Jerome A; Palmay, Lesley; Ho, Grace; Raybardhan, Sumit; Gill, Suzanne; Kan, Tiffany; Campbell, Jackie; Kiss, Alex; McCready, Janine B; Das, Pavani; Minnema, Brian; Powis, Jeff E; Walker, Sandra A N; Ferguson, Heather; Wong, Benny; Weber, Elizabeth

    2017-06-01

    Beta-lactam allergy skin testing (BLAST) is recommended by antimicrobial stewardship program (ASP) guidelines, yet few studies have systematically evaluated its impact when delivered at point-of-care. We conducted a pragmatic multicenter prospective evaluation of the use of point-of-care BLAST by ASPs. In staggered 3-month intervals, ASP teams at three hospitals received training by allergists to offer BLAST for eligible patients with infectious diseases receiving non-preferred beta-lactam therapy due to severity of their allergy. The primary outcome was the proportion of patients receiving the preferred beta-lactam therapy. Of 827 patients with reported beta-lactam allergy over 15-months, beta-lactam therapy was preferred among 632(76%). During baseline periods, 50% (124/246) received preferred beta-lactam therapy based on history, compared with 60% (232/386) during the intervention periods (p=0.02), which improved further to 81% (313/386) upon provision of BLAST (pcare across three hospital ASPs resulted in greater use of preferred beta-lactam therapy without increasing the risk of adverse drug reactions. Longer term studies are needed to better assess the safety and clinical impact of this ASP intervention. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  7. Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

    2011-07-01

    The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

  8. Endoscopic management of unresectable malignant gastroduodenal obstruction with a nitinol uncovered metal stent: A prospective Japanese multicenter study

    Science.gov (United States)

    Sasaki, Reina; Sakai, Yuji; Tsuyuguchi, Toshio; Nishikawa, Takao; Fujimoto, Tatsuya; Mikami, Shigeru; Sugiyama, Harutoshi; Yokosuka, Osamu

    2016-01-01

    AIM: To determine the safety and efficacy of endoscopic duodenal stent placement in patients with malignant gastric outlet obstruction. METHODS: This prospective, observational, multicenter study included 39 consecutive patients with malignant gastric outlet obstruction. All patients underwent endoscopic placement of a nitinol, uncovered, self-expandable metal stent. The primary outcome was clinical success at 2 wk after stent placement that was defined as improvement in the Gastric Outlet Obstruction Scoring System score relative to the baseline. RESULTS: Technical success was achieved in all duodenal stent procedures. Procedure-related complications occurred in 4 patients (10.3%) in the form of mild pneumonitis. No other morbidities or mortalities were observed. The clinical success rate was 92.3%. The mean survival period after stent placement was 103 d. The mean period of stent patency was 149 d and the patency remained acceptable for the survival period. Stent dysfunction occurred in 3 patients (7.7%) on account of tumor growth. CONCLUSION: Endoscopic management using duodenal stents for patients with incurable malignant gastric outlet obstruction is safe and improved patients’ quality of life. PMID:27076769

  9. Clinical effect of intratympanic dexamethasone injection in acute unilateral tinnitus: A prospective, placebo-controlled, multicenter study.

    Science.gov (United States)

    Lee, Hyun-Jin; Kim, Min-Beom; Yoo, Shin-Young; Park, Shi Nae; Nam, Eui-Cheol; Moon, In Seok; Lee, Ho-Ki

    2018-01-01

    The purpose of this study was to investigate the effectiveness of intratympanic dexamethasone injection (ITDI) in acute tinnitus of presumed cochlear origin. A prospective, randomized, placebo-controlled, double-blinded, multicenter study. Between August 2013 and December 2015, 54 patients with unilateral tinnitus were enrolled at four different centers. Patients were assigned either to an ITDI (n = 27) or an intratympanic normal saline injection (ITNI; n = 27) group through block randomization. Intratympanic injections were administered four times over 2 weeks. At 4 weeks after initial injection, we analyzed the improvement rates of tinnitus using the tinnitus handicap Inventory (THI) and visual analogue scale (VAS) for loudness, awareness, and annoyance. We defined improvement as the reduction of more than 7 points or of more than 20% in the final THI score compared to the initial THI score. The initial mean hearing thresholds and VAS and THI scores of the two groups did not differ significantly. At 4 weeks after initial injection, the mean VAS and THI scores of both groups had significantly reduced. However, the improvement rate did not differ significantly between the groups (ITDI, 51.9%; ITNI, 59.3%). The results indicate that ITDI might not be more effective than ITNI for the treatment of acute unilateral tinnitus. Therefore, ITDI should not be considered as the main treatment for patients presenting with acute tinnitus as the primary symptom. 1b. Laryngoscope, 128:184-188, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

  10. Effectiveness of intra-articular injections of sodium hyaluronate-chondroitin sulfate in knee osteoarthritis: a multicenter prospective study.

    Science.gov (United States)

    Rivera, Fabrizio; Bertignone, Luca; Grandi, Giancarlo; Camisassa, Roberto; Comaschi, Guido; Trentini, Diego; Zanone, Marco; Teppex, Giuseppe; Vasario, Gabriele; Fortina, Giorgio

    2016-03-01

    Intra-articular injection of hyaluronic acid is a well-established therapy for the treatment of knee osteoarthritis. The aim of the study was to assess the effectiveness and safety of the use of Arthrum HCS(®) (40 mg hyaluronic acid and 40 mg chondroitin sulfate in 2 mL). This was an open, multicenter, prospective study. Men or women over 40 years of age with documented knee osteoarthritis and WOMAC subscore A (severity of pain) ≥25 were enrolled. They received three weekly intra-articular injections of sodium hyaluronate 2 % and chondroitin sulfate 2 % in combination. WOMAC subscore A was assessed at 1, 3 and 6 months after the last injection. One hundred and twelve patients were included (women, 66 %). The mean (SD) WOMAC subscore A decreased from 52.1 (15.2) at inclusion to 20.5 (19.7) at month 6 (P chondroitin sulfate in reducing pain (77 %), improving mobility (78 %) and reducing the consumption of analgesics (74 %). Only one adverse effect was reported by one patient (knee tumefaction). These results suggest that intra-articular injections of Arthrum HCS(®) (sodium hyaluronate plus chondroitin sulfate) in patients with knee osteoarthritis are efficient and safe. These results should be confirmed in a randomized controlled study. IV.

  11. Centrally Determined Standardization of Flow Cytometry Methods Reduces Interlaboratory Variation in a Prospective Multicenter Study

    Science.gov (United States)

    Westera, Liset; van Viegen, Tanja; Jeyarajah, Jenny; Azad, Azar; Bilsborough, Janine; van den Brink, Gijs R; Cremer, Jonathan; Danese, Silvio; D'Haens, Geert; Eckmann, Lars; Faubion, William; Filice, Melissa; Korf, Hannelie; McGovern, Dermot; Panes, Julian; Salas, Azucena; Sandborn, William J; Silverberg, Mark S; Smith, Michelle I; Vermeire, Severine; Vetrano, Stefania; Shackelton, Lisa M; Stitt, Larry; Jairath, Vipul; Levesque, Barrett G; Spencer, David M; Feagan, Brian G; Vande Casteele, Niels

    2017-01-01

    Objectives: Flow cytometry (FC) aids in characterization of cellular and molecular factors involved in pathologic immune responses. Although FC has potential to facilitate early drug development in inflammatory bowel disease, interlaboratory variability limits its use in multicenter trials. Standardization of methods may address this limitation. We compared variability in FC-aided quantitation of T-cell responses across international laboratories using three analytical strategies. Methods: Peripheral blood mononuclear cells (PBMCs) were isolated from three healthy donors, stimulated with phorbol 12-myristate 13-acetate and ionomycin at a central laboratory, fixed, frozen, and shipped to seven international laboratories. Permeabilization and staining was performed in triplicate at each laboratory using a common protocol and centrally provided reagents. Gating was performed using local gating with a local strategy (LGLS), local gating with a central strategy (LGCS), and central gating (CG). Median cell percentages were calculated across triplicates and donors, and reported for each condition and strategy. The coefficient of variation (CV) was calculated across laboratories. Between-strategy comparisons were made using a two-way analysis of variance adjusting for donor. Results: Mean interlaboratory CV ranged from 1.8 to 102.1% depending on cell population and gating strategy (LGLS, 4.4–102.1% LGCS, 10.9–65.6% CG, 1.8–20.9%). Mean interlaboratory CV differed significantly across strategies and was consistently lower with CG. Conclusions: Central gating was the only strategy with mean CVs consistently lower than 25%, which is a proposed standard for pharmacodynamic and exploratory biomarker assays. PMID:29095427

  12. rhBMP-2 for posterolateral instrumented lumbar fusion: a multicenter prospective randomized controlled trial.

    Science.gov (United States)

    Hurlbert, R John; Alexander, David; Bailey, Stewart; Mahood, James; Abraham, Ed; McBroom, Robert; Jodoin, Alain; Fisher, Charles

    2013-12-01

    Multicenter randomized controlled trial. To evaluate the effect of recombinant human bone morphogenetic protein (rhBMP-2) on radiographical fusion rate and clinical outcome for surgical lumbar arthrodesis compared with iliac crest autograft. In many types of spinal surgery, radiographical fusion is a primary outcome equally important to clinical improvement, ensuring long-term stability and axial support. Biologic induction of bone growth has become a commonly used adjunct in obtaining this objective. We undertook this study to objectify the efficacy of rhBMP-2 compared with traditional iliac crest autograft in instrumented posterolateral lumbar fusion. Patients undergoing 1- or 2-level instrumented posterolateral lumbar fusion were randomized to receive either autograft or rhBMP-2 for their fusion construct. Clinical and radiographical outcome measures were followed for 2 to 4 years postoperatively. One hundred ninety seven patients were successfully randomized among the 8 participating institutions. Adverse events attributable to the study drug were not significantly different compared with controls. However, the control group experienced significantly more graft-site complications as might be expected. 36-Item Short Form Health Survey, Oswestry Disability Index, and leg/back pain scores were comparable between the 2 groups. After 4 years of follow-up, radiographical fusion rates remained significantly higher in patients treated with rhBMP-2 (94%) than those who received autograft (69%) (P = 0.007). The use of rhBMP-2 for instrumented posterolateral lumbar surgery significantly improves the chances of radiographical fusion compared with the use of autograft. However, there is no associated improvement in clinical outcome within a 4-year follow-up period. These results suggest that use of rhBMP-2 should be considered in cases where lumbar arthrodesis is of primary concern.

  13. Prospective assessment of clinical symptoms associated with enterovirus and parechovirus genotypes in a multicenter study in Dutch children.

    Science.gov (United States)

    de Crom, S C M; Rossen, J W A; de Moor, R A; Veldkamp, E J M; van Furth, A M; Obihara, C C

    2016-04-01

    Human non-polio enterovirus (EV) and human parechovirus (HPeV) are important pathogens of viral infection and aseptic meningitis in children. The aim of this study is to prospectively compare the incidence, clinical signs, blood and cerebrospinal fluid in EV and HPeV infected children. To compare the clinical symptoms and laboratory data of children with different EV and HPeV genotypes. This study is part of a multicenter prospective cohort study. Children were included in 3 different hospitals in The Netherlands from 2008 to 2011. Of 285 included patients, 140 (49%) had EV and 44 (15%) HPeV infection. Of children with EV infection 9 (6%) had EV-A, 109 (78%) EV-B, 12 (9%) had a non-type able EV and in 10 (7%) no genotyping was performed. Of children with HPeV infection, 24 (55%) had HPeV-3, 6 (14%) HPeV-1, 2 (5%) HPeV-4 and 1 (2%) HPeV-6. Meningitis was more frequent in EV than in HPeV infected children (54% vs. 36%, p=0.046), and in EV-B than EV-A infected children (60 vs. 33%). In contrast gastroenteritis was more frequent in HPeV than EV infected children (30% vs. 15%, p=0.030), and significantly more in HPeV-1 than HPeV-3 infected children (p<0.001). EV infection is more often associated with meningitis and HPeV infection more often with a gastro-enteritis. EV genotype B infection is more often associated with meningitis than EV genotype A infection. HPeV-1 infection was more often associated with gastroenteritis than HPeV-3 infection. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. Prospective validation of a prognostic model for respiratory syncytial virus bronchiolitis in late preterm infants: a multicenter birth cohort study.

    Directory of Open Access Journals (Sweden)

    Maarten O Blanken

    Full Text Available This study aimed to update and validate a prediction rule for respiratory syncytial virus (RSV hospitalization in preterm infants 33-35 weeks gestational age (WGA.The RISK study consisted of 2 multicenter prospective birth cohorts in 41 hospitals. Risk factors were assessed at birth among healthy preterm infants 33-35 WGA. All hospitalizations for respiratory tract infection were screened for proven RSV infection by immunofluorescence or polymerase chain reaction. Multivariate logistic regression analysis was used to update an existing prediction model in the derivation cohort (n = 1,227. In the validation cohort (n = 1,194, predicted versus actual RSV hospitalization rates were compared to determine validity of the model.RSV hospitalization risk in both cohorts was comparable (5.7% versus 4.9%. In the derivation cohort, a prediction rule to determine probability of RSV hospitalization was developed using 4 predictors: family atopy (OR 1.9; 95%CI, 1.1-3.2, birth period (OR 2.6; 1.6-4.2, breastfeeding (OR 1.7; 1.0-2.7 and siblings or daycare attendance (OR 4.7; 1.7-13.1. The model showed good discrimination (c-statistic 0.703; 0.64-0.76, 0.702 after bootstrapping. External validation showed good discrimination and calibration (c-statistic 0.678; 0.61-0.74.Our prospectively validated prediction rule identifies infants at increased RSV hospitalization risk, who may benefit from targeted preventive interventions. This prediction rule can facilitate country-specific, cost-effective use of RSV prophylaxis in late preterm infants.

  15. Comparative analysis of perioperative complications between a multicenter prospective cervical deformity database and the Nationwide Inpatient Sample database.

    Science.gov (United States)

    Passias, Peter G; Horn, Samantha R; Jalai, Cyrus M; Poorman, Gregory; Bono, Olivia J; Ramchandran, Subaraman; Smith, Justin S; Scheer, Justin K; Sciubba, Daniel M; Hamilton, D Kojo; Mundis, Gregory; Oh, Cheongeun; Klineberg, Eric O; Lafage, Virginie; Shaffrey, Christopher I; Ames, Christopher P

    2017-11-01

    Complication rates for adult cervical deformity are poorly characterized given the complexity and heterogeneity of cases. To compare perioperative complication rates following adult cervical deformity corrective surgery between a prospective multicenter database for patients with cervical deformity (PCD) and the Nationwide Inpatient Sample (NIS). Retrospective review of prospective databases. A total of 11,501 adult patients with cervical deformity (11,379 patients from the NIS and 122 patients from the PCD database). Perioperative medical and surgical complications. The NIS was queried (2001-2013) for cervical deformity discharges for patients ≥18 years undergoing cervical fusions using International Classification of Disease, Ninth Revision (ICD-9) coding. Patients ≥18 years from the PCD database (2013-2015) were selected. Equivalent complications were identified and rates were compared. Bonferroni correction (pdatabases. A total of 11,379 patients from the NIS database and 122 patiens from the PCD database were identified. Patients from the PCD database were older (62.49 vs. 55.15, pdatabase. The PCD database had an increased risk of reporting overall complications than the NIS (odds ratio: 2.81, confidence interval: 1.81-4.38). Only device-related complications were greater in the NIS (7.1% vs. 1.1%, p=.007). Patients from the PCD database displayed higher rates of the following complications: peripheral vascular (0.8% vs. 0.1%, p=.001), gastrointestinal (GI) (2.5% vs. 0.2%, pdatabases (p>.004). Based on surgicalapproach, the PCD reported higher GI and neurologic complication rates for combined anterior-posterior procedures (pdatabase revealed higher overall and individual complication rates and higher data granularity. The nationwide database may underestimate complications of patients with adult cervical deformity (ACD) particularly in regard to perioperative surgical details owing to coding and deformity generalizations. The surgeon-maintained database

  16. Permissive weight bearing in trauma patients with fracture of the lower extremities: prospective multicenter comparative cohort study.

    Science.gov (United States)

    Kalmet, Pishtiwan H S; Meys, Guido; V Horn, Yvette Y; Evers, Silvia M A A; Seelen, Henk A M; Hustinx, Paul; Janzing, Heinrich; Vd Veen, Alexander; Jaspars, Coen; Sintenie, Jan Bernard; Blokhuis, Taco J; Poeze, Martijn; Brink, Peter R G

    2018-02-02

    The standard aftercare treatment in surgically treated trauma patients with fractures around or in a joint, known as (peri)- or intra-articular fractures of the lower extremities, is either non-weight bearing or partial weight bearing. We have developed an early permissive weight bearing post-surgery rehabilitation protocol in surgically treated patients with fractures of the lower extremities. In this proposal we want to compare our early permissive weight bearing protocol to the existing current non-weight bearing guidelines in a prospective comparative cohort study. The study is a prospective multicenter comparative cohort study in which two rehabilitation aftercare treatments will be contrasted, i.e. permissive weight bearing and non-weight bearing according to the AO-guideline. The study population consists of patients with a surgically treated fracture of the pelvis/acetabulum or a surgically treated (peri)- or intra-articular fracture of the lower extremities. The inclusion period is 12 months. The duration of follow up is 6 months, with measurements taken at baseline, 2,6,12 and 26 weeks post-surgery. ADL with Lower Extremity Functional Scale. Outcome variables for compliance, as measured with an insole pressure measurement system, encompass peak load and step duration. This study will investigate the (cost-) effectiveness of a permissive weight bearing aftercare protocol. The results will provide evidence whether a permissive weight bearing protocol is more effective than the current non-weight bearing protocol. The study is registered in the Dutch Trial Register ( NTR6077 ). Date of registration: 01-09-2016.

  17. The Role of Transnasal Esophagoscopy in ENT Office: A Prospective, Multicenter Study in Korea

    OpenAIRE

    Chung, Eun-Jae; Rho, Young-Soo; Jung, Kwang-Yoon; Kim, Jae-Wook; Lee, Seung-Won

    2014-01-01

    Objectives The purpose of study was to report the current role of transnasal esophagoscopy (TNE) in Korea. Methods One hundred thirty-seven patients who underwent TNE at Soonchunhyang University Bucheon Hospital (n=69) and Korea University Anam Hospital (n=68) from July 2007 to February 2009 were prospectively analyzed. Laryngopharyngeal reflux disease (LPRD) patients without any response to proton-pump inhibitor (n=102), and patients with complaints that require esophagoscopy as part of thei...

  18. Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial.

    Science.gov (United States)

    Ram-Liebig, Gouya; Barbagli, Guido; Heidenreich, Axel; Fahlenkamp, Dirk; Romano, Giuseppe; Rebmann, Udo; Standhaft, Diana; van Ahlen, Hermann; Schakaki, Samer; Balsmeyer, Ulf; Spiegler, Maria; Knispel, Helmut

    2017-09-01

    Harvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data). 99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24months. All but one patient had ≥1, 77.1% (64 of 83)≥2 and 31.3% (26 of 83)≥4 previous surgical treatments. Pre- and postoperative mean±SD peak flow rate (Qmax) were 8.3±4.7mL/s (n=57) and 25.4±14.7mL/s (n=51). SR was 67.3% (95% CI 57.6-77.0) at 12 and 58.2% (95% CI 47.7-68.7) at 24months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported. TEOMG is safe and efficient in urethroplasty. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  19. Multicenter prospective randomized study comparing the technique of using a bovine pericardium biological prosthesis reinforcement in parietal herniorrhaphy (Tutomesh TUTOGEN) with simple parietal herniorrhaphy, in a potentially contaminated setting.

    Science.gov (United States)

    Nedelcu, Marius; Verhaeghe, Pierre; Skalli, Mehdi; Champault, Gerard; Barrat, Christophe; Sebbag, Hugues; Reche, Fabian; Passebois, Laurent; Beyrne, Daniel; Gugenheim, Jean; Berdah, Stephane; Bouayed, Amine; Michel Fabre, Jean; Nocca, David

    2016-03-01

    The use of parietal synthetic prosthetic reinforcement material in potentially contaminated settings is not recommended, as there is a risk that the prosthesis may become infected. Thus, simple parietal herniorrhaphy, is the conventional treatment, even though there is a significant risk that the hernia may recur. Using new biomaterials of animal origin presently appears to offer a new therapeutic solution, but their effectiveness has yet to be demonstrated. The purpose of this multicenter prospective randomized single-blind study was to compare the surgical treatment of inguinal hernia or abdominal incisional hernia by simple parietal herniorrhaphy without prosthetic reinforcement (Group A), with Tutomesh TUTOGEN biological prosthesis reinforcement parietal herniorrhaphy (Group B), in a potentially contaminated setting. We examined early postoperative complications in the first month after the operation, performed an assessment after one year of survival without recurrence and analyzed the quality of life and pain of the patients (using SF-12 health status questionnaire and Visual Analog Pain Scale) at 1, 6, and 12 months, together with an economic impact study. Hundred and thirty four patients were enrolled between January 2009 and October 2010 in 20 French hospitals. The groups were comparable with respect to their enrollment characteristics, their history, types of operative indications and procedures carried out. At one month post-op, the rate of infectious complications (n(A) = 11(18.33%) vs. n(B) = 12(19.05%), p = 0.919) was not significantly different between the two groups. The assessment after one year of survival without recurrence revealed that survival was significantly greater in Group B (Group A recurrence: 10, Group B: 3; p = 0.0475). No difference in the patients' quality of life was demonstrated at 1, 6, or 12 months. However, at the 1 month follow-up, the "perceived health" rating seemed better in the group with Tutomesh (p

  20. Validation of the new graded prognostic assessment scale for brain metastases: a multicenter prospective study

    International Nuclear Information System (INIS)

    Villà, Salvador; Verger, Eugènia; Balañà, Carme; Graus, Francesc; Weber, Damien C; Moretones, Cristina; Mañes, Anabel; Combescure, Christophe; Jové, Josep; Puyalto, Paloma; Cuadras, Patricia; Bruna, Jordi

    2011-01-01

    Prognostic indexes are useful to guide tailored treatment strategies for cancer patients with brain metastasis (BM). We evaluated the new Graded Prognostic Assessment (GPA) scale in a prospective validation study to compare it with two published prognostic indexes. A total of 285 newly diagnosed BM (n = 85 with synchronous BM) patients, accrued prospectively between 2000 and 2009, were included in this analysis. Mean age was 62 ± 12.0 years. The median KPS and number of BM was 70 (range, 20-100) and 3 (range, 1-50), respectively. The majority of primary tumours were lung (53%), or breast (17%) cancers. Treatment was administered to 255 (89.5%) patients. Only a minority of patients could be classified prospectively in a favourable prognostic class: GPA 3.5-4: 3.9%; recursive partitioning analysis (RPA) 1, 8.4% and Basic Score for BM (BSBM) 3, 9.1%. Mean follow-up (FU) time was 5.2 ± 4.7 months. During the period of FU, 225 (78.9%) patients died. The 6 months- and 1 year-OS was 36.9% and 17.6%, respectively. On multivariate analysis, performance status (P < 0.001), BSBM (P < 0.001), Center (P = 0.007), RPA (P = 0.02) and GPA (P = 0.03) were statistically significant for OS. The survival prediction performances' of all indexes were identical. Noteworthy, the significant OS difference observed within 3 months of diagnosis between the BSBM, RPA and GPA classes/groups was not observed after this cut-off time point. Harrell's concordance indexes C were 0.58, 0.61 and 0.58 for the GPA, BSBM and RPA, respectively. Our data suggest that the new GPA index is a valid prognostic index. In this prospective study, the prediction performance was as good as the BSBM or RPA systems. These published indexes may however have limited long term prognostication capability

  1. Object Permanence in 3 1/2- and 4 1/2-Month-Old Infants.

    Science.gov (United States)

    Baillargeon, Renee

    1987-01-01

    Three experiments test object permanenece in 3 1/2- and 4 1/2-month-old infants, and use an impossible-possible-habituation event format. The 4 1/2-month-olds, and the 3 1/2-month-olds who were fast habituators, look reliably longer at the impossible than at the possible event. Results seriously question Piaget's (1954) claims regarding the age at…

  2. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.

    Science.gov (United States)

    Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea

    2017-04-01

    Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.

  3. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

    Science.gov (United States)

    Sugano, Kentaro; Matsumoto, Yasushi; Itabashi, Tsukasa; Abe, Sumihisa; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Chiba, Tsutomu; Matsui, Shigeyuki; Kanto, Tatsuya; Shimada, Kazuyuki; Uchiyama, Shinichiro; Uemura, Naomi; Hiramatsu, Naoki

    2011-06-01

    The efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15 mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers. Patients were randomized to receive lansoprazole 15 mg daily (n = 226) or gefarnate 50 mg twice daily (n = 235) for 12 months or longer in a prospective, multicenter, double-blind, randomized active-controlled trial, followed by a 6-month follow-up study with open-label lansoprazole treatment. The study utilized 94 sites in Japan and 461 Japanese patients with a history of gastric or duodenal ulcers who required long-term LDA therapy for cardiovascular and cerebrovascular disease. The primary endpoint was the development of gastric or duodenal ulcers. The cumulative incidence of gastric or duodenal ulcers on days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 1.5, 2.1, and 3.7%, respectively, in the lansoprazole group versus 15.2, 24.0, and 31.7%, respectively, in the gefarnate group. The risk of ulcer development was significantly (log-rank test, P lansoprazole group than in the gefarnate group, with the hazard ratio being 0.099 (95% confidence interval [CI] 0.042-0.230). Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy.

  4. Gender Differences in Patients with Intracerebral Hemorrhage: A Hospital-Based Multicenter Prospective Study

    Directory of Open Access Journals (Sweden)

    Monique Bueno Alves

    2012-10-01

    Full Text Available Gender differences are well described for patients with ischemic stroke. Conversely, sex disparities in stroke presentation, risk factors, treatment, and outcomes for intracerebral hemorrhage (ICH were not previously studied. Our objective was to compare the frequency of risk factors, management patterns, symptoms at presentation, complication rates, and outcomes between genders in patients with ICH in Fortaleza, Brazil. Methods: Data were prospectively collected from patients admitted to 19 hospitals in Fortaleza with a diagnosis of ICH by trained research coordinators from June 2009 to October 2010. Daily visits to the selected hospitals were performed, and all patients admitted with a diagnosis of ICH were prospectively evaluated. Results: We evaluated 364 patients, 47.5% of whom were women. Men were younger (59.3 ± 14.58 years vs. 66.3 ± 14.6 years, p Conclusion: Overall risk factors for ICH in men and women were similar in our series. Men had a higher frequency of alcohol abuse and smoking. Women were older, had an increased time length from symptoms onset to hospital admission and had a worse prognosis at discharge. A better understanding of the gender disparities in patients with ICH will hopefully lead to better outcomes in both sexes in the future.

  5. Risk factors for shunt malfunction in pediatric hydrocephalus: a multicenter prospective cohort study.

    Science.gov (United States)

    Riva-Cambrin, Jay; Kestle, John R W; Holubkov, Richard; Butler, Jerry; Kulkarni, Abhaya V; Drake, James; Whitehead, William E; Wellons, John C; Shannon, Chevis N; Tamber, Mandeep S; Limbrick, David D; Rozzelle, Curtis; Browd, Samuel R; Simon, Tamara D

    2016-04-01

    OBJECT The rate of CSF shunt failure remains unacceptably high. The Hydrocephalus Clinical Research Network (HCRN) conducted a comprehensive prospective observational study of hydrocephalus management, the aim of which was to isolate specific risk factors for shunt failure. METHODS The study followed all first-time shunt insertions in children younger than 19 years at 6 HCRN centers. The HCRN Investigator Committee selected, a priori, 21 variables to be examined, including clinical, radiographic, and shunt design variables. Shunt failure was defined as shunt revision, subsequent endoscopic third ventriculostomy, or shunt infection. Important a priori-defined risk factors as well as those significant in univariate analyses were then tested for independence using multivariate Cox proportional hazard modeling. RESULTS A total of 1036 children underwent initial CSF shunt placement between April 2008 and December 2011. Of these, 344 patients experienced shunt failure, including 265 malfunctions and 79 infections. The mean and median length of follow-up for the entire cohort was 400 days and 264 days, respectively. The Cox model found that age younger than 6 months at first shunt placement (HR 1.6 [95% CI 1.1-2.1]), a cardiac comorbidity (HR 1.4 [95% CI 1.0-2.1]), and endoscopic placement (HR 1.9 [95% CI 1.2-2.9]) were independently associated with reduced shunt survival. The following had no independent associations with shunt survival: etiology, payer, center, valve design, valve programmability, the use of ultrasound or stereotactic guidance, and surgeon experience and volume. CONCLUSIONS This is the largest prospective study reported on children with CSF shunts for hydrocephalus. It confirms that a young age and the use of the endoscope are risk factors for first shunt failure and that valve type has no impact. A new risk factor-an existing cardiac comorbidity-was also associated with shunt failure.

  6. Pancreatic Cancer: Multicenter Prospective Data Collection and Analysis by the Hungarian Pancreatic Study Group.

    Science.gov (United States)

    Lakatos, Gábor; Balázs, Anita; Kui, Balázs; Gódi, Szilárd; Szücs, Ákos; Szentesi, Andrea; Szentkereszty, Zsolt; Szmola, Richárd; Kelemen, Dezső; Papp, Róbert; Vincze, Áron; Czimmer, József; Pár, Gabriella; Bajor, Judit; Szabó, Imre; Izbéki, Ferenc; Halász, Adrienn; Leindler, László; Farkas, Gyula; Takács, Tamás; Czakó, László; Szepes, Zoltán; Hegyi, Péter; Kahán, Zsuzsanna

    2016-06-01

    Pancreatic cancer is a devastating disease with poor prognosis. There is very limited information available regarding the epidemiology and treatment strategies of pancreatic cancer in Central Europe. The purpose of the study was to prospectively collect and analyze data of pancreatic cancer in the Hungarian population. The Hungarian Pancreatic Study Group (HPSG) organized prospective, uniform data collection. Altogether 354 patients were enrolled from 14 Hungarian centers. Chronic pancreatitis was present in 3.7% of the cases, while 33.7% of the patients had diabetes. Family history for pancreatic cancer was positive in 4.8%. The most frequent presenting symptoms included pain (63.8%), weight loss (63%) and jaundice (52.5%). The reported frequency of smoking and alcohol consumption was lower than expected (28.5% and 27.4%, respectively). The majority of patients (75.6%) were diagnosed with advanced disease. Most patients (83.6%) had a primary tumor located in the pancreatic head. The histological diagnosis was ductal adenocarcinoma in 90.7% of the cases, while neuroendocrine tumor was present in 5.3%. Biliary stent implantation was performed in 166 patients, 59.2% of them received metal stents. Primary tumor resection was performed in 60 (16.9%) patients. Enteral or biliary bypass was done in 35 and 49 patients, respectively. In a multivariate Cox-regression model, smoking status and presence of gemcitabine-based chemotherapy were identified as independent predictors for overall survival. We report the first data from a large cohort of Hungarian pancreatic cancer patients. We identified smoking status and chemotherapy as independent predictors in this cohort.

  7. Impact of lymphoma treatments on spermatogenesis and sperm deoxyribonucleic acid: a multicenter prospective study from the CECOS network.

    Science.gov (United States)

    Bujan, Louis; Walschaerts, Marie; Brugnon, Florence; Daudin, Myriam; Berthaut, Isabelle; Auger, Jacques; Saias, Jacqueline; Szerman, Ethel; Moinard, Nathalie; Rives, Nathalie; Hennebicq, Sylvianne

    2014-09-01

    To determine consequences of lymphoma treatments on sperm characteristics and sperm DNA, and to evaluate predictors of sperm recovery. Multicenter prospective longitudinal study of patients analyzed before treatment and after 3, 6, 12, and 24 months. University hospitals. Seventy-five Hodgkin lymphoma and non-Hodgkin lymphoma patients and a control group of 257 fertile men. Semen analyses, and sperm DNA and chromatin assessments. Comparisons of sperm characteristics before and after treatment. Patients already had altered sperm characteristics before lymphoma treatment, with no identified risk factor. Sperm count, total sperm count, motility, and vitality decreased after treatment, with lowest values at 3 and 6 months. Twelve months after treatment, mean sperm count recovered to pretreatment values after doxorubicin, bleomycin, vinblastine, darcarbacine (ABVD) or ABVD+radiotherapy, but not after doxorubicin, cyclophosphamide, vincristine, prednisone (CHOP) or mechlorethamine, oncovin, procarbazine, prednisone (MOPP) chemotherapies. It was noteworthy that 7% of patients remained azoospermic at 24 months. After 24 months, Kaplan-Meier estimates showed that more than 90% of patients will recover normal sperm count after ABVD or ABVD+radiotherapy vs. 61% for CHOP chemotherapies. In multivariate analyses including diagnosis and treatment protocol, only pretreatment total sperm count was related to recovery. Compared with a control group, lymphoma patients had higher sperm chromatin alterations and DNA fragmentation before any treatment. After treatment, DNA fragmentation assessed by TUNEL assay and sperm chromatin structure assay decreased from 3 and 6 months, respectively, while remaining higher than in the control group during follow-up. Lymphoma patients had altered sperm DNA and chromatin before treatment. Lymphoma treatment had damaging effects on spermatogenesis. These data on both the recovery period according to treatment modalities and the pre- and post

  8. Serum ARCHITECT PIVKA-II reference interval in healthy Chinese adults: Sub-analysis from a prospective multicenter study.

    Science.gov (United States)

    Yan, Cunling; Hu, Jian; Yang, Jia; Chen, Zhaoyun; Li, Huijun; Wei, Lianhua; Zhang, Wei; Xing, Hao; Sang, Guoyao; Wang, Xiaoqin; Han, Ruilin; Liu, Ping; Li, Zhihui; Li, Zhiyan; Huang, Ying; Jiang, Li; Li, Shunjun; Dai, Shuyang; Wang, Nianyue; Yang, Yongfeng; Ma, Li; Soh, Andrew; Beshiri, Agim; Shen, Feng; Yang, Tian; Fan, Zhuping; Zheng, Yijie; Chen, Wei

    2018-04-01

    Protein induced by vitamin K absence or antagonist-II (PIVKA-II) has been widely used as a biomarker for liver cancer diagnosis in Japan for decades. However, the reference intervals for serum ARCHITECT PIVKA-II have not been established in the Chinese population. Thus, this study aimed to measure serum PIVKA-II levels in healthy Chinese subjects. This is a sub-analysis from the prospective, cross-sectional and multicenter study (ClinicalTrials.gov Identifier: NCT03047603). A total of 892 healthy participants (777 Han and 115 Uygur) with complete health checkup results were recruited from 7 regional centers in China. Serum PIVKA-II level was measured by ARCHITECT immunoassay. All 95% reference ranges were estimated by nonparametric method. The distribution of PIVKA-II values showed significant difference with ethnicity and sex, but not age. The 95% reference range of PIVKA-II was 13.62-40.38 mAU/ml in Han Chinese subjects and 15.16-53.74 mAU/ml in Uygur subjects. PIVKA-II level was significantly higher in males than in females (P < 0.001). The 95% reference range of PIVKA-II was 15.39-42.01 mAU/ml in Han males while 11.96-39.13 mAU/ml in Han females. The reference interval of serum PIVKA-II on the Architect platform was established in healthy Chinese adults. This will be valuable for future clinical and laboratory studies performed using the Architect analyzer. Different ethnic backgrounds and analytical methods underline the need for redefining the reference interval of analytes such as PIVKA-II, in central laboratories in different countries. Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  9. A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

    Science.gov (United States)

    Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

    2013-02-08

    Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

  10. A multicenter prospective cohort study of volume management after subarachnoid hemorrhage: circulatory characteristics of pulmonary edema after subarachnoid hemorrhage.

    Science.gov (United States)

    Obata, Yoshiki; Takeda, Junichi; Sato, Yohei; Ishikura, Hiroyasu; Matsui, Toru; Isotani, Eiji

    2016-08-01

    OBJECT Subarachnoid hemorrhage (SAH) is often accompanied by pulmonary complications, which may lead to poor outcomes and death. This study investigated the incidence and cause of pulmonary edema in patients with SAH by using hemodynamic monitoring with PiCCO-plus pulse contour analysis. METHODS A total of 204 patients with SAH were included in a multicenter prospective cohort study to investigate hemodynamic changes after surgical clipping or coil embolization of ruptured cerebral aneurysms by using a PiCCO-plus device. Changes in various hemodynamic parameters after SAH were analyzed statistically. RESULTS Fifty-two patients (25.5%) developed pulmonary edema. Patients with pulmonary edema (PE group) were significantly older than those without pulmonary edema (non-PE group) (p = 0.017). The mean extravascular lung water index was significantly higher in the PE group than in the non-PE group throughout the study period. The pulmonary vascular permeability index (PVPI) was significantly higher in the PE group than in the non-PE group on Day 6 (p = 0.029) and Day 10 (p = 0.011). The cardiac index of the PE group was significantly decreased biphasically on Days 2 and 10 compared with that of the non-PE group. In the early phase (Days 1-5 after SAH), the daily water balance of the PE group was slightly positive. In the delayed phase (Days 6-14 after SAH), the serum C-reactive protein level and the global end-diastolic volume index were significantly higher in the PE group than in the non-PE group, whereas the PVPI tended to be higher in the PE group. CONCLUSIONS Pulmonary edema that occurs in the early and delayed phases after SAH is caused by cardiac failure and inflammatory (i.e., noncardiogenic) conditions, respectively. Measurement of the extravascular lung water index, cardiac index, and PVPI by PiCCO-plus monitoring is useful for identifying pulmonary edema in patients with SAH.

  11. In vivo and in vitro performance of a China-made hemodialysis machine: a multi-center prospective controlled study.

    Science.gov (United States)

    Wang, Yong; Chen, Xiang-Mei; Cai, Guang-Yan; Li, Wen-Ge; Zhang, Ai-Hua; Hao, Li-Rong; Shi, Ming; Wang, Rong; Jiang, Hong-Li; Luo, Hui-Min; Zhang, Dong; Sun, Xue-Feng

    2017-08-02

    To evaluate the in vivo and in vitro performance of a China-made dialysis machine (SWS-4000). This was a multi-center prospective controlled study consisting of both long-term in vitro evaluations and cross-over in vivo tests in 132 patients. The China-made SWS-4000 dialysis machine was compared with a German-made dialysis machine (Fresenius 4008) with regard to Kt/V values, URR values, and dialysis-related adverse reactions in patients on maintenance hemodialysis, as well as the ultrafiltration rate, the concentration of electrolytes in the proportioned dialysate, the rate of heparin injection, the flow rate of the blood pump, and the rate of malfunction. The Kt/V and URR values at the 1st and 4th weeks of dialysis as well as the incidence of adverse effects did not differ between the two groups in cross-over in vivo tests (P > 0.05). There were no significant differences between the two groups in the error values of the ultrafiltration rate, the rate of heparin injection or the concentrations of electrolytes in the proportioned dialysate at different time points under different parameter settings. At weeks 2 and 24, with the flow rate of the blood pump set at 300 mL/min, the actual error of the SWS-4000 dialysis machine was significantly higher than that of the Fresenius 4008 dialysis machine (P  0.05). The malfunction rate was higher in the SWS-4000 group than in the Fresenius 4008 group (P Fresenius 4008 dialysis machine; however, the malfunction rate of the former is higher than that of the latter in in vitro tests. The stability and long-term accuracy of the SWS-4000 dialysis machine remain to be improved.

  12. One-Year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial.

    Science.gov (United States)

    Rastan, Aljoscha; McKinsey, James F; Garcia, Lawrence A; Rocha-Singh, Krishna J; Jaff, Michael R; Noory, Elias; Zeller, Thomas

    2015-12-01

    To report a subgroup analysis of the prospective, multicenter, single-arm DEFINITIVE LE trial to assess the effectiveness of directional atherectomy for the treatment of infrapopliteal artery lesions at 1 year. In the DEFINITIVE LE trial, follow-up assessments occurred up to 1 year postprocedure. Of the 800 patients enrolled, 145 subjects with 189 infrapopliteal lesions met the criteria for this analysis. Seventy (48.3%) and 75 (51.7%) patients were suffering critical limb ischemia (CLI) and intermittent claudication, respectively; 68.3% (99/145) had diabetes. The mean lesion length was 58±44 mm (all lesions); 20.2% were occluded. The primary endpoint for patients with claudication was duplex ultrasound-derived primary patency, while for subjects with CLI it was freedom from major amputation of the target limb at 1 year. Endpoints and adverse events were independently assessed. Procedure success (≤30% residual stenosis) was achieved in 84% of treated lesions. The 1-year primary patency rate was 84% (claudicants 89.6% and CLI patients 78%, p=0.11), and the freedom from major amputation rate was 97.1% (claudicants 100% and CLI 93.8%, p=0.03). In both claudication and CLI patients, significant improvements in Rutherford category and objective measures of walking distance and quality of life were seen at 1 year in comparison to baseline. This study demonstrates that directional atherectomy in infrapopliteal arteries results in promising technical and clinical results at 1 year for claudicant as well as CLI patients. © The Author(s) 2015.

  13. The burden and etiology of community-onset pneumonia in the aging Japanese population: a multicenter prospective study.

    Directory of Open Access Journals (Sweden)

    Konosuke Morimoto

    Full Text Available The increasing burden of pneumonia in adults is an emerging health issue in the era of global population aging. This study was conducted to elucidate the burden of community-onset pneumonia (COP and its etiologic fractions in Japan, the world's most aged society.A multicenter prospective surveillance for COP was conducted from September 2011 to January 2013 in Japan. All pneumonia patients aged ≥ 15 years, including those with community-acquired pneumonia (CAP and health care-associated pneumonia (HCAP, were enrolled at four community hospitals on four major islands. The COP burden was estimated based on the surveillance data and national statistics.A total of 1,772 COP episodes out of 932,080 hospital visits were enrolled during the surveillance. The estimated overall incidence rates of adult COP, hospitalization, and in-hospital death were 16.9 (95% confidence interval, 13.6 to 20.9, 5.3 (4.5 to 6.2, and 0.7 (0.6 to 0.8 per 1,000 person-years (PY, respectively. The incidence rates sharply increased with age; the incidence in people aged ≥ 85 years was 10-fold higher than that in people aged 15-64 years. The estimated annual number of adult COP cases in the entire Japanese population was 1,880,000, and 69.4% were aged ≥ 65 years. Aspiration-associated pneumonia (630,000 was the leading etiologic category, followed by Streptococcus pneumoniae-associated pneumonia (530,000, Haemophilus influenzae-associated pneumonia (420,000, and respiratory virus-associated pneumonia (420,000, including influenza-associated pneumonia (30,000.A substantial portion of the COP burden occurs among elderly members of the Japanese adult population. In addition to the introduction of effective vaccines for S. pneumoniae and influenza, multidimensional approaches are needed to reduce the pneumonia burden in an aging society.

  14. Efficacy of Magnesium Trihydrate of Ursodeoxycholic Acid and Chenodeoxycholic Acid for Gallstone Dissolution: A Prospective Multicenter Trial.

    Science.gov (United States)

    Hyun, Jong Jin; Lee, Hong Sik; Kim, Chang Duck; Dong, Seok Ho; Lee, Seung-Ok; Ryu, Ji Kon; Lee, Don Haeng; Jeong, Seok; Kim, Tae Nyeun; Lee, Jin; Koh, Dong Hee; Park, Eun Taek; Lee, In-Seok; Yoo, Byung Moo; Kim, Jin Hong

    2015-07-01

    Cholecystectomy is necessary for the treatment of symptomatic or complicated gallbladder (GB) stones, but oral litholysis with bile acids is an attractive alternative therapeutic option for asymptomatic or mildly symptomatic patients. This study was conducted to evaluate the efficacy of magnesium trihydrate of ursodeoxycholic acid (UDCA) and chenodeoxycholic acid (CDCA) on gallstone dissolution and to investigate improvements in gallstone-related symptoms. A prospective, multicenter, phase 4 clinical study to determine the efficacy of orally administered magnesium trihydrate of UDCA and CDCA was performed from January 2011 to June 2013. The inclusion criteria were GB stone diameter ≤15 mm, GB ejection fraction ≥50%, radiolucency on plain X-ray, and asymptomatic/mildly symptomatic patients. The patients were prescribed one capsule of magnesium trihydrate of UDCA and CDCA at breakfast and two capsules at bedtime for 6 months. The dissolution rate, response rate, and change in symptom score were evaluated. A total of 237 subjects were enrolled, and 195 subjects completed the treatment. The dissolution rate was 45.1% and the response rate was 47.2% (92/195) after 6 months of administration of magnesium trihydrate of UDCA and CDCA. Only the stone diameter was significantly associated with the response rate. Both the symptom score and the number of patients with symptoms significantly decreased regardless of stone dissolution. Adverse events necessitating discontinuation of the drug, surgery, or endoscopic management occurred in 2.5% (6/237) of patients. Magnesium trihydrate of UDCA and CDCA is a well-tolerated bile acid that showed similar efficacy for gallstone dissolution and improvement of gallstone-related symptoms as that shown in previous studies.

  15. Quality of life is modestly improved in older patients with mild primary hyperparathyroidism postoperatively: results of a prospective multicenter study.

    Science.gov (United States)

    Blanchard, Claire; Mathonnet, Muriel; Sebag, Frédéric; Caillard, Cécile; Kubis, Caroline; Drui, Delphine; van Nuvel, Elise; Ansquer, Catherine; Henry, Jean-François; Masson, Damien; Kraeber-Bodéré, Françoise; Hardouin, Jean-Benoît; Zarnegar, Rasa; Hamy, Antoine; Mirallié, Eric

    2014-10-01

    The objectives of this study were to evaluate, in mild primary hyperparathyroidism (pHPT) patients, the quality of life (QoL) using the SF-36 questionnaire before and after parathyroidectomy and to detect preoperatively patients who benefit the most from surgery. Most pHPT patients present a mild pHPT defined by calcemia ≤11.4 mg/dL. For these patients, there is debate about whether they should be managed with surveillance, medical therapy, or surgery. A prospective multicenter study investigated QoL (SF-36) in patients with mild pHPT before and after parathyroidectomy in four university hospitals. Laboratory results and SF-36 scores were obtained preoperatively and postoperatively (3, 6, and 12 months). One hundred sixteen patients were included. After surgery, the biochemical cure rate was 98%. Preoperatively, the mental component summary and the physical component summary (PCS) were 38.69 of 100 and 39.53 of 100, respectively. At 1 year, the MCS and the PCS were 41.29 of 100 and 42.03 of 100. The subgroup analysis showed a more significant improvement in patients < 70 years and with calcemia ≥10.4 mg/dL. Postoperative PCS was correlated with age and preoperative PCS: variation = 32.11 - 0.21 × age - 0.4 × preoperative PCS. Men did not improve their MCS postoperatively. Only women with a preoperative MCS <43.6 of 100 showed postoperative improvement. This study showed, in patients with mild pHPT, an improvement of QoL 1 year after parathyroidectomy. Patients <70 years and with calcemia ≥10.4 mg/dL had a more significant improvement.

  16. Prognostic role of LDL cholesterol in non-dialysis chronic kidney disease: Multicenter prospective study in Italy.

    Science.gov (United States)

    De Nicola, Luca; Provenzano, Michele; Chiodini, Paolo; D'Arrigo, Graziella; Tripepi, Giovanni; Del Vecchio, Lucia; Conte, Giuseppe; Locatelli, Francesco; Zoccali, Carmine; Minutolo, Roberto

    2015-08-01

    The prognostic role of LDL in non-dialysis chronic kidney disease (CKD) is still undefined. We addressed this question in a multicenter prospective study including patients referred to nephrologist for management. 1306 patients with CKD stage III-V were studied at basal visit in 79 Italian nephrology clinics in 2004-2006, and then followed for survival analyses. Study endpoints were incident cardiovascular -CV events (fatal and major non-fatal) and renal events (start of renal replacement therapy or eGFR halving). Mean age was 67.6 ± 11.8 years, male 65%, diabetes 25%, CV disease 27%, and eGFR 35.8 ± 12.5 mL/min/1.73 m(2). LDL was 119 ± 40 mg/dL, with high levels in 50.1% and 82.8% defined on the basis of the individual CV risk profile estimated according to ATPIII 2001 and ESC 2012 guidelines (LDL 100 to 160, and >70 or >100 mg/dL, respectively). Over a median follow up of 2.87 years, 178 CV and 181 renal events occurred. At multivariable Cox analyses, CV risk linearly increased with higher LDL (hazard ratio-HR per 40 mg/dL higher LDL: 1.20, 95% confidence intervals-CI 1.03-1.39); risk doubled when considering high LDL defined according to ESC 2012 (HR 2.37, 95%CI 1.39-4.03) while this association was not significant when considering the higher threshold levels of ATPIII 2001 (HR 1.10, 95%CI 0.82-1.49). No association emerged between LDL and renal risk. In non-dialysis CKD patients, CV risk increases linearly with higher LDL and is more than doubled when considering the lower threshold values currently indicated for defining optimal LDL level. Copyright © 2015 Elsevier B.V. All rights reserved.

  17. A multicenter prospective cohort study on camera navigation training for key user groups in minimally invasive surgery.

    Science.gov (United States)

    Graafland, Maurits; Bok, Kiki; Schreuder, Henk W R; Schijven, Marlies P

    2014-06-01

    Untrained laparoscopic camera assistants in minimally invasive surgery (MIS) may cause suboptimal view of the operating field, thereby increasing risk for errors. Camera navigation is often performed by the least experienced member of the operating team, such as inexperienced surgical residents, operating room nurses, and medical students. The operating room nurses and medical students are currently not included as key user groups in structured laparoscopic training programs. A new virtual reality laparoscopic camera navigation (LCN) module was specifically developed for these key user groups. This multicenter prospective cohort study assesses face validity and construct validity of the LCN module on the Simendo virtual reality simulator. Face validity was assessed through a questionnaire on resemblance to reality and perceived usability of the instrument among experts and trainees. Construct validity was assessed by comparing scores of groups with different levels of experience on outcome parameters of speed and movement proficiency. The results obtained show uniform and positive evaluation of the LCN module among expert users and trainees, signifying face validity. Experts and intermediate experience groups performed significantly better in task time and camera stability during three repetitions, compared to the less experienced user groups (P < .007). Comparison of learning curves showed significant improvement of proficiency in time and camera stability for all groups during three repetitions (P < .007). The results of this study show face validity and construct validity of the LCN module. The module is suitable for use in training curricula for operating room nurses and novice surgical trainees, aimed at improving team performance in minimally invasive surgery. © The Author(s) 2013.

  18. Prospective, multicenter clinical trial to validate new products for skin tests in the diagnosis of allergy to penicillin.

    Science.gov (United States)

    Fernández, J; Torres, M J; Campos, J; Arribas-Poves, F; Blanca, M

    2013-01-01

    Allergy to penicillin is the most commonly reported type of drug hypersensitivity. Diagnosis is currently confirmed using skin tests with benzylpenicillin reagents, ie, penicilloyl-polylysine (PPL) as the major determinant of benzylpenicillin and benzylpenicillin, benzylpenicilloate and benzylpenilloate as a minor determinant mixture (MDM). To synthesize and assess the diagnostic capacity of 2 new benzylpenicillin reagents in patients with immediate hypersensitivity reactions to B-lactams: benzylpenicilloyl octa-L-lysine (BP-OL) as the major determinant and benzylpenilloate (penilloate) as the minor determinant. Prospective multicenter clinical trial performed in 18 Spanish centers. Efficacy was assessed by detection of positive skin test results in an allergic population and negative skin test results in a nonallergic, drug-exposed population. Sensitivity, specificity, and negative and positive predictive values were determined. The study sample comprised 94 allergic patients: 31 (35.23%) presented anaphylaxis, 4 (4.55%) anaphylactic shock, 51 (58.04%) urticaria, and 2 (2.27%) no specific condition. The culprit 8-lactams were amoxicillin in 63 cases (71.60%), benzypencillin in 14 cases (15.89%), cephalosporins in 2 cases (2.27%), other drugs in 3 cases (3.42%), and unidentified agents in 6 cases (6.82%). The results of testing with BP-OL were positive in 46 cases (52.3%); the results of testing with penilloate were positive in 33 cases (37.5%). When both reagents were taken into consideration, sensitivity reached 61.36% and specificity 100%. Skin testing with penilloate was significantly more often negative when the interval between the reaction and the study was longer. The sensitivity of BP-OL and penilloate was 61%. Considering that amoxicillin was the culprit drug in 71% of reactions, these results indicate that most patients were allergic to the whole group of penicillins. These data support the use of benzylpenicillin determinants in the diagnosis of allergy

  19. Adjuvant chemotherapy and radiotherapy in triple-negative breast carcinoma: A prospective randomized controlled multi-center trial

    International Nuclear Information System (INIS)

    Wang, Jianhua; Shi, Mei; Ling, Rui; Xia Yuesheng; Luo Shanquan; Fu Xuehai; Xiao Feng; Li Jianping; Long Xiaoli; Wang Jianguo; Hou Zengxia; Chen Yunxia; Zhou Bin; Xu, Man

    2011-01-01

    Background and purpose: Triple-negative breast cancer (TNBC) presents a high risk breast cancer that lacks the benefit from hormone treatment, chemotherapy is the main strategy even though it exists in poor prognosis. Use of adjuvant radiation therapy, which significantly decreases breast cancer mortality, has not been well described among poor TNBC women. The aim of this study was to evaluate whether the combination of chemotherapy and radiotherapy could significantly increase survival outcomes in TNBC women after mastectomy. Patients and methods: A prospective randomized controlled multi-center study was performed between February 2001 and February 2006 and comprised 681 women with triple-negative stage I-II breast cancer received mastectomy, of them, 315 cases received systemic chemotherapy alone, 366 patients received radiation after the course of chemotherapy. Recurrence-free survival (RFS) and overall survival (OS) were estimated. Simultaneously local and systemic toxicity were observed. Results: After a median follow-up of 86.5 months, five-year RFS rates were 88.3% and 74.6% for adjuvant chemotherapy plus radiation and adjuvant chemotherapy alone, respectively, with significant difference between the two groups (HR 0.77 [95% CI 0.72, 0.98]; P = 0.02). Five-year OS significantly improved in adjuvant chemotherapy plus radiation group compared with chemotherapy alone (90.4% and 78.7%) (HR 0.79 [95% CI 0.74, 0.97]; P = 0.03). No severe toxicity was reported. Conclusions: Patients received standard adjuvant chemotherapy plus radiation therapy was more effective than chemotherapy alone in women with triple-negative early-stage breast cancer after mastectomy.

  20. Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT Study.

    Directory of Open Access Journals (Sweden)

    Sara E Moore

    Full Text Available Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated. We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating

  1. Risk factors for post-colorectal endoscopic submucosal dissection (ESD) coagulation syndrome: a multicenter, prospective, observational study

    Science.gov (United States)

    Arimoto, Jun; Higurashi, Takuma; Kato, Shingo; Fuyuki, Akiko; Ohkubo, Hidenori; Nonaka, Takashi; Yamaguchi, Yoshikazu; Ashikari, Keiichi; Chiba, Hideyuki; Goto, Shungo; Taguri, Masataka; Sakaguchi, Takashi; Atsukawa, Kazuhiro; Nakajima, Atsushi

    2018-01-01

    Background and study aims  Colorectal cancer (CRC) is one of the most common neoplasms and endoscopic submucosal dissection (ESD) is an effective treatment for early-stage CRC. However, it has been observed that patients undergoing ESD often complain of pain, even if ESD has been successfully performed. Risk factors for such pain still remain unknown. The aim of this study was to explore the risk factors for post-colorectal ESD coagulation syndrome (PECS). Patients and methods  This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS. We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure. Results  PECS occurred in 15/106 (14.2 %), and 10 were women ( P  = 0.01, OR: 7.74 [1.6 – 36.4]), 7 had lesions in the cecum ( P   90 min ( P  = 0.002, OR: 10.3 [2.4 – 44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47 % [7/15] vs. 2 % [2/91], P  PECS group.  Conclusions  Female gender, location of lesion in the cecum, and ESD operation time > 90 minutes were significant risk factors independent of PECS. These findings are important to management of PECS.  PMID:29527556

  2. Diagnostic Accuracy of Copeptin in the Differential Diagnosis of the Polyuria-polydipsia Syndrome: A Prospective Multicenter Study.

    Science.gov (United States)

    Timper, Katharina; Fenske, Wiebke; Kühn, Felix; Frech, Nica; Arici, Birsen; Rutishauser, Jonas; Kopp, Peter; Allolio, Bruno; Stettler, Christoph; Müller, Beat; Katan, Mira; Christ-Crain, Mirjam

    2015-06-01

    The polyuria-polydipsia syndrome comprises primary polydipsia (PP) and central and nephrogenic diabetes insipidus (DI). Correctly discriminating these entities is mandatory, given that inadequate treatment causes serious complications. The diagnostic "gold standard" is the water deprivation test with assessment of arginine vasopressin (AVP) activity. However, test interpretation and AVP measurement are challenging. The objective was to evaluate the accuracy of copeptin, a stable peptide stoichiometrically cosecreted with AVP, in the differential diagnosis of polyuria-polydipsia syndrome. This was a prospective multicenter observational cohort study from four Swiss or German tertiary referral centers of adults >18 years old with the history of polyuria and polydipsia. A standardized combined water deprivation/3% saline infusion test was performed and terminated when serum sodium exceeded 147 mmol/L. Circulating copeptin and AVP levels were measured regularly throughout the test. Final diagnosis was based on the water deprivation/saline infusion test results, clinical information, and the treatment response. Fifty-five patients were enrolled (11 with complete central DI, 16 with partial central DI, 18 with PP, and 10 with nephrogenic DI). Without prior thirsting, a single baseline copeptin level >21.4 pmol/L differentiated nephrogenic DI from other etiologies with a 100% sensitivity and specificity, rendering a water deprivation testing unnecessary in such cases. A stimulated copeptin >4.9 pmol/L (at sodium levels >147 mmol/L) differentiated between patients with PP and patients with partial central DI with a 94.0% specificity and a 94.4% sensitivity. A stimulated AVP >1.8 pg/mL differentiated between the same categories with a 93.0% specificity and a 83.0% sensitivity. This study was limited by incorporation bias from including AVP levels as a diagnostic criterion. Copeptin is a promising new tool in the differential diagnosis of the polyuria-polydipsia syndrome

  3. A Prospective, Holistic, Multicenter Approach to Tracking and Understanding Bloodstream Infections in Pediatric Hematology-Oncology Patients.

    Science.gov (United States)

    Gaur, Aditya H; Bundy, David G; Werner, Eric J; Hord, Jeffrey D; Miller, Marlene R; Tang, Li; Lawlor, John P; Billett, Amy L

    2017-06-01

    OBJECTIVE To assess the burden of bloodstream infections (BSIs) among pediatric hematology-oncology (PHO) inpatients, to propose a comprehensive, all-BSI tracking approach, and to discuss how such an approach helps better inform within-center and across-center differences in CLABSI rate DESIGN Prospective cohort study SETTING US multicenter, quality-improvement, BSI prevention network PARTICIPANTS PHO centers across the United States who agreed to follow a standardized central-line-maintenance care bundle and track all BSI events and central-line days every month. METHODS Infections were categorized as CLABSI (stratified by mucosal barrier injury-related, laboratory-confirmed BSI [MBI-LCBI] versus non-MBI-LCBI) and secondary BSI, using National Healthcare Safety Network (NHSN) definitions. Single positive blood cultures (SPBCs) with NHSN defined common commensals were also tracked. RESULTS Between 2013 and 2015, 34 PHO centers reported 1,110 BSIs. Among them, 708 (63.8%) were CLABSIs, 170 (15.3%) were secondary BSIs, and 232 (20.9%) were SPBCs. Most SPBCs (75%) occurred in patients with profound neutropenia; 22% of SPBCs were viridans group streptococci. Among the CLABSIs, 51% were MBI-LCBI. Excluding SPBCs, CLABSI rates were higher (88% vs 77%) and secondary BSI rates were lower (12% vs 23%) after the NHSN updated the definition of secondary BSI (Papproach that could help better assess across-center and within-center differences in infection rates, including CLABSI. This approach enables informed decision making by healthcare providers, payors, and the public. Infect Control Hosp Epidemiol 2017;38:690-696.

  4. One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

    Science.gov (United States)

    Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

    2013-02-01

    The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

  5. Surgical treatment for osteoporotic thoracolumbar vertebral collapse using vertebroplasty with posterior spinal fusion: a prospective multicenter study.

    Science.gov (United States)

    Katsumi, Keiichi; Hirano, Toru; Watanabe, Kei; Ohashi, Masayuki; Yamazaki, Akiyoshi; Ito, Takui; Sawakami, Kimihiko; Sano, Atsuki; Kikuchi, Ren; Endo, Naoto

    2016-11-01

    The study aimed to investigate the clinical outcomes and limitations after vertebroplasty with posterior spinal fusion (VP+PSF) without neural decompression for osteoporotic vertebral collapse. We conducted a prospective multicenter study including 45 patients (12 men and 33 women, mean age: 77.0 years) evaluated between 2008 and 2012. Operation time, blood loss, visual analog scale (VAS) of back pain, neurological status, kyphosis angle in the fused area, and vertebral union of the collapsed vertebra were evaluated. The mean operation time was 162 min and blood loss was 381 mL. The postoperative VAS score significantly improved, and the neurological status improved in 35 patients (83 %), and none of the remaining patients demonstrated a deteriorating neurological status at two years post-operatively. The mean kyphosis angle pre-operatively, immediately post-operatively, and two years post-operatively was 23.8°, 10.7°, and 24.3°, respectively, and there was no significant difference between the angles pre-operatively and two years post-operatively. The extensive correction of kyphosis >16° was a risk factor for a higher correction loss and subsequent fracture. Union of the collapsed vertebra was observed in 43 patients (95 %) at two years post-operatively. The present study suggests that spinal stabilization rather than neural decompression is essential to treat OVC. Short-segment VP+PSF can achieve a high union rate of collapsed vertebra and provide a significant improvement in back pain or neurological status with less invasive surgery, but has a limit of kyphosis correction more than 16°.

  6. Severity of Pneumonia in Under 5-Year-Old Children from Developing Countries: A Multicenter, Prospective, Observational Study.

    Science.gov (United States)

    Bénet, Thomas; Picot, Valentina Sanchez; Awasthi, Shally; Pandey, Nitin; Bavdekar, Ashish; Kawade, Anand; Robinson, Annick; Rakoto-Andrianarivelo, Mala; Sylla, Maryam; Diallo, Souleymane; Russomando, Graciela; Basualdo, Wilma; Komurian-Pradel, Florence; Endtz, Hubert; Vanhems, Philippe; Paranhos-Baccalà, Gláucia; For The Gabriel Network

    2017-07-01

    Pneumonia is the leading cause of death in children. The objectives were to evaluate the microbiological agents linked with hypoxemia in hospitalized children with pneumonia from developing countries, to identify predictors of hypoxemia, and to characterize factors associated with in-hospital mortality. A multicenter, observational study was conducted in five hospitals, from India (Lucknow, Vadu), Madagascar (Antananarivo), Mali (Bamako), and Paraguay (San Lorenzo). Children aged 2-60 months with radiologically confirmed pneumonia were enrolled prospectively. Respiratory and whole blood specimens were collected, identifying viruses and bacteria by real-time multiplex polymerase chain reaction (PCR). Microbiological agents linked with hypoxemia at admission (oxygen saturation pneumonia cases (3,338 hospitalization days) were analyzed; 13 patients died within 14 days of hospitalization. Hypoxemia prevalence was 17.3%. Detection of human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) in respiratory samples was independently associated with increased risk of hypoxemia (adjusted odds ratio [aOR] = 2.4, 95% confidence interval [95% CI] = 1.0-5.8 and aOR = 2.5, 95% CI = 1.1-5.3, respectively). Lower chest indrawing and cyanosis were predictive of hypoxemia (positive likelihood ratios = 2.3 and 2.4, respectively). Predictors of death were Streptococcus pneumoniae detection by blood PCR (crude hazard ratio [cHR] = 4.6, 95% CI = 1.5-14.0), procalcitonin ≥ 50 ng/mL (cHR = 22.4, 95% CI = 7.3-68.5) and hypoxemia (cHR = 4.8, 95% CI = 1.6-14.4). These findings were consistent on bivariate analysis. hMPV and RSV in respiratory samples were linked with hypoxemia, and S. pneumoniae in blood was associated with increased risk of death among hospitalized children with pneumonia in developing countries.

  7. Fragility Hip Fractures in Elderly Patients in Bhubaneswar, India (2012-2014): A Prospective Multicenter Study of 1031 Elderly Patients.

    Science.gov (United States)

    Dash, Sunil K; Panigrahi, Ranajit; Palo, Nishit; Priyadarshi, Ashok; Biswal, Manas

    2015-03-01

    Elderly patients with hip fracture constitute Single Largest Group of Emergency Orthopaedics Admissions. In 2050, 6.26 million hip fractures worldwide, approximately 50%, will occur in Asia. Only small number of reports on incidence of hip fractures in the Asian population exist. India lacks data registry for fragility hip fractures, therefore, the magnitude and standard of patient care are not known. A prospective multicenter study was conducted from January 2012 to April 2014 to describe population-based longitudinal trends, namely, age-specific incidence, fracture type, timing of presentation, kilometers traveled, timing of surgery, hospital stay, man hours lost, pressure ulcers, weight bearing, 30-day return, 3-month mortality, and so on, of fragility hip fractures. A total of 1031 patients were included with 59.7% females and 40.3% of male patients, with a female-male ratio of 1.5:1. Commonest mode: Falls 45%. 56.4% IT fractures. 66.2%patients operated, Operative/Conservative Ratio of 2.8:1. Patients travel a mean distance of 86.4 kilometers for quality treatment. Of the patients, 85.9 % presented late due to ignorance and misguiding quack practice. Incidence of delayed surgery was 69.3%. Persistent electrolytes imbalance and hyperglycemia normalized in 81.2% by second or third postoperative day. The man hours lost was 157.85 hours/person. Medical complications was more (90%) in patients who had delays in surgeries and presentation. Mortality rate was 6.2 %. Patients travel long for quality treatment, most of them are misguided, present late with significant complications and sufferings, and their pockets half drained depriving them off best treatment. Early presentation and operation have better prognosis and rehabilitation, facilitates early return to work, and independence. Increased pressure sores, infections, hospital stay, treatment cost, depression, and mortality are directly related to delays in surgeries and presentation. Estimated losses according to

  8. Post-Traumatic Stress Disorder among Older Adults Experiencing Motor Vehicle Collision: A Multicenter Prospective Cohort Study.

    Science.gov (United States)

    Platts-Mills, Timothy F; Nebolisa, Bo C; Flannigan, Sean A; Richmond, Natalie L; Domeier, Robert M; Swor, Robert A; Hendry, Phyllis L; Peak, David A; Rathlev, Niels K; Jones, Jeffrey S; Lee, David C; Jones, Christopher W; McLean, Samuel A

    2017-09-01

    To characterize risk factors for and consequences of post-traumatic stress disorder (PTSD) among older adults evaluated in the emergency department (ED) following motor vehicle collision (MVC). Prospective multicenter longitudinal study (2011-2015). 9 EDs across the United States. Adults aged 65 years and older who presented to an ED after MVC without severe injuries. PTSD symptoms were assessed 6 months after the ED visit using the Impact of Event Scale-Revised. Of 223 patients, clinically significant PTSD symptoms at 6 months were observed in 21% (95% CI 16%-26%). PTSD symptoms were more common in patients who did not have a college degree, had depressive symptoms prior to the MVC, perceived the MVC as life-threatening, had severe ED pain, and expected their physical or emotional recovery time to be greater than 30 days. Three factors (ED pain severity [0-10 scale], perceived life-threatening MVC [0-10 scale], and pre-MVC depressive symptoms [yes to either of two questions]), predicted 6-month PTSD symptoms with an area under the curve of 0.76. Compared to patients without PTSD symptoms, those with PTSD symptoms were at higher risk for persistent pain (72% versus 30%), functional decline (67% versus 42%), and new disability (49% versus 18%). Among older adults treated in the ED following MVC, clinically significant PTSD symptoms at 6 months were present in 21% of patients and were associated with adverse health outcomes. Increased risk for PTSD development can be identified with moderate accuracy using information readily available in the ED. Copyright © 2017 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  9. Cellular microparticle and thrombogram phenotypes in the Prospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study: correlation with coagulopathy

    Science.gov (United States)

    Matijevic, Nena; Wang, Yao-Wei W.; Wade, Charles E.; Holcomb, John B.; Cotton, Bryan A.; Schreiber, Martin A.; Muskat, Peter; Fox, Erin E.; del Junco, Deborah J.; Cardenas, Jessica C.; Rahbar, Mohammad H.; Cohen, Mitchell Jay

    2014-01-01

    Background Trauma-induced coagulopathy following severe injury is associated with increased bleeding and mortality. Injury may result in alteration of cellular phenotypes and release of cell-derived microparticles (MP). Circulating MPs are procoagulant and support thrombin generation (TG) and clotting. We evaluated MP and TG phenotypes in severely injured patients at admission, in relation to coagulopathy and bleeding. Methods As part of the Prospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, research blood samples were obtained from 180 trauma patients requiring transfusions at 5 participating centers. Twenty five healthy controls and 40 minimally injured patients were analyzed for comparisons. Laboratory criteria for coagulopathy was activated partial thromboplastin time (APTT) ≥35 sec. Samples were analyzed by Calibrated Automated Thrombogram to assess TG, and by flow cytometry for MP phenotypes [platelet (PMP), erythrocyte (RMP), leukocyte (LMP), endothelial (EMP), tissue factor (TFMP), and Annexin V positive (AVMP)]. Results 21.7% of patients were coagulopathic with the median (IQR) APTT of 44 sec (37, 53), and an Injury Severity Score of 26 (17, 35). Compared to controls, patients had elevated EMP, RMP, LMP, and TFMP (all p<0.001), and enhanced TG (p<0.0001). However, coagulopathic PROMMTT patients had significantly lower PMP, TFMP, and TG, higher substantial bleeding, and higher mortality compared to non-coagulopathic patients (all p<0.001). Conclusions Cellular activation and enhanced TG are predominant after trauma and independent of injury severity. Coagulopathy was associated with lower thrombin peak and rate compared to non-coagulopathic patients, while lower levels of TF-bearing PMPs were associated with substantial bleeding. PMID:25086657

  10. Sedation and Anesthesia in Pediatric and Congenital Cardiac Catheterization: A Prospective Multicenter Experience.

    Science.gov (United States)

    Lin, C Huie; Desai, Sanyukta; Nicolas, Ramzi; Gauvreau, Kimberlee; Foerster, Susan; Sharma, Anshuman; Armsby, Laurie; Marshall, Audrey C; Odegard, Kirsten; DiNardo, James; Vincent, Julie; El-Said, Howaida; Spaeth, James; Goldstein, Bryan; Holzer, Ralf; Kreutzer, Jackie; Balzer, David; Bergersen, Lisa

    2015-10-01

    Sedation/anesthesia is critical to cardiac catheterization in the pediatric/congenital heart patient. We sought to identify current sedation/anesthesia practices, the serious adverse event rate related to airway, sedation, or anesthesia, and the rate of intra-procedural conversion from procedural sedation to the use of assisted ventilation or an artificial airway. Data from 13,611 patients who underwent catheterization at eight institutions were prospectively collected from 2007 to 2010. Ninety-four (0.69 %) serious sedation/airway-related adverse events occurred; events were more likely to occur in smaller patients (anesthesia, LMA, or tracheostomy, whereas 4232 (31 %) were managed with procedural sedation without an artificial airway, of which 75 (1.77 %) patients were converted to assisted ventilation/general anesthesia. Young age (risk procedure (category 4, OR 10.1, 95 % CI 6.5-15.6, p pediatric/congenital patients was associated with a low rate of serious sedation/airway-related adverse events. Smaller patients with non-cardiac comorbidities or low mixed venous oxygen saturation may be at higher risk. Patients under 1 year of age, undergoing high-risk procedures, or requiring continuous pressor/inotrope support may be at higher risk of requiring conversion from procedural sedation to assisted ventilation/general anesthesia.

  11. Risk factors for tuberculosis in dialysis patients: a prospective multi-center clinical trial

    Directory of Open Access Journals (Sweden)

    Goumenos Demetrios S

    2009-11-01

    Full Text Available Abstract Background Profound alterations in immune responses associated with uraemia and exacerbated by dialysis increase the risk of developing active tuberculosis (TB in chronic haemodialysis patients (HDPs. In the current study, was determined the impact of various risk factors on TB development. Our aim was to identify which HDPs need anti-TB preventive therapy. Methods Prospective study of 272 HDPs admitted, through a 36-month period, to our institutions. Specific Relative Risk (RR for TB was estimated, considering age matched subjects from the general population as reference group. Entering the study all patients were tested with tuberculin (TST. Using Cox's proportional hazard model the independent effect of various risk factors associated with TB development was estimated. Results History of TB, dialysis efficiency, use of Vitamin D supplements, serum albumin and zinc levels were not proved to influence significantly the risk for TB, in contrast to: advanced age (>65 years, BMI, diabetes mellitus, tuberculin reactivity, healed TB lesions on chest X-ray and time on dialysis. Elderly (>70 years old HDPs (Adjusted RR 25.3, 95%CI 20.4-28.4, P Conclusion The above mentioned factors have to be considered by the clinicians, evaluating for TB in HDPs. Positive TST, the existence of predisposing risk factors and/or old TB lesions on chest X-ray, will guide the diagnosis of latent TB infection and the selection of those HDPs who need preventive chemoprophylaxis.

  12. Respiratory Viruses in Invasively Ventilated Critically Ill Patients-A Prospective Multicenter Observational Study.

    Science.gov (United States)

    van Someren Gréve, Frank; Juffermans, Nicole P; Bos, Lieuwe D J; Binnekade, Jan M; Braber, Annemarije; Cremer, Olaf L; de Jonge, Evert; Molenkamp, Richard; Ong, David S Y; Rebers, Sjoerd P H; Spoelstra-de Man, Angelique M E; van der Sluijs, Koenraad F; Spronk, Peter E; Verheul, Kirsten D; de Waard, Monique C; de Wilde, Rob B P; Winters, Tineke; de Jong, Menno D; Schultz, Marcus J

    2018-01-01

    The presence of respiratory viruses and the association with outcomes were assessed in invasively ventilated ICU patients, stratified by admission diagnosis. Prospective observational study. Five ICUs in the Netherlands. Between September 1, 2013, and April 30, 2014, 1,407 acutely admitted and invasively ventilated patients were included. None. Nasopharyngeal swabs and tracheobronchial aspirates were collected upon intubation and tested for 14 respiratory viruses. Out of 1,407 patients, 156 were admitted because of a severe acute respiratory infection and 1,251 for other reasons (non-severe acute respiratory infection). Respiratory viruses were detected in 28.8% of severe acute respiratory infection patients and 17.0% in non-severe acute respiratory infection (p < 0.001). In one third, viruses were exclusively detected in tracheobronchial aspirates. Rhinovirus and human metapneumovirus were more prevalent in severe acute respiratory infection patients (9.6% and 2.6% vs 4.5 and 0.2%; p = 0.006 and p < 0.001). In both groups, there were no associations between the presence of viruses and the number of ICU-free days at day 28, crude mortality, and mortality in multivariate regression analyses. Respiratory viruses are frequently detected in acutely admitted and invasively ventilated patients. Rhinovirus and human metapneumovirus are more frequently found in severe acute respiratory infection patients. Detection of respiratory viruses is not associated with worse clinically relevant outcomes in the studied cohort of patients.

  13. Down syndrome as risk factor for respiratory syncytial virus hospitalization: A prospective multicenter epidemiological study.

    Science.gov (United States)

    Sánchez-Luna, Manuel; Medrano, Constancio; Lirio, Julián

    2017-03-01

    Respiratory syncytial virus (RSV) infection in childhood, particularly in premature infants, is associated with significant morbidity and mortality. To compare the hospitalization rates due to RSV infection and severity of disease between infants with and without Down syndrome (DS) born at term and without other associated risk factors for severe RSV infection. In a prospective multicentre epidemiological study, 93 infants were included in the DS cohort and 68 matched by sex and data of birth (±1 week) and were followed up to 1 year of age and during a complete RSV season. The hospitalization rate for all acute respiratory infection was significantly higher in the DS cohort than in the non-DS cohort (44.1% vs 7.7%, P<.0001). Hospitalizations due to RSV were significantly more frequent in the DH cohort than in the non-DS cohort (9.7% vs 1.5%, P=.03). RSV prophylaxis was recorded in 33 (35.5%) infants with DS. The rate of hospitalization according to presence or absence of RSV immunoprophylaxis was 3.0% vs 15%, respectively. Infants with DS showed a higher rate of hospitalization due to acute lower respiratory tract infection and RSV infection compared to non-DS infants. Including DS infants in recommendations for immunoprophylaxis of RSV disease should be considered. © 2016 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd.

  14. Economic consequences incurred by living kidney donors: a Canadian multi-center prospective study.

    Science.gov (United States)

    Klarenbach, S; Gill, J S; Knoll, G; Caulfield, T; Boudville, N; Prasad, G V R; Karpinski, M; Storsley, L; Treleaven, D; Arnold, J; Cuerden, M; Jacobs, P; Garg, A X

    2014-04-01

    Some living kidney donors incur economic consequences as a result of donation; however, these costs are poorly quantified. We developed a framework to comprehensively assess economic consequences from the donor perspective including out-of-pocket cost, lost wages and home productivity loss. We prospectively enrolled 100 living kidney donors from seven Canadian centers between 2004 and 2008 and collected and valued economic consequences ($CAD 2008) at 3 months and 1 year after donation. Almost all (96%) donors experienced economic consequences, with 94% reporting travel costs and 47% reporting lost pay. The average and median costs of lost pay were $2144 (SD 4167) and $0 (25th-75th percentile 0, 2794), respectively. For other expenses (travel, accommodation, medication and medical), mean and median costs were $1780 (SD 2504) and $821 (25th-75th percentile 242, 2271), respectively. From the donor perspective, mean cost was $3268 (SD 4704); one-third of donors incurred cost >$3000, and 15% >$8000. The majority of donors (83%) reported inability to perform usual household activities for an average duration of 33 days; 8% reported out-of-pocket costs for assistance with these activities. The economic impact of living kidney donation for some individuals is large. We advocate for programs to reimburse living donors for their legitimate costs. © 2014 The Authors. American Journal of Transplantation Published by Wiley Periodicals, Inc. on behalf of American Society of Transplant Surgeons.

  15. Prospective observational multicenter study to define a diagnostic algorithm for biliary candidiasis.

    Science.gov (United States)

    Lenz, Philipp; Eckelskemper, Franziska; Erichsen, Thomas; Lankisch, Tim; Dechêne, Alexander; Lubritz, Gabriele; Lenze, Frank; Beyna, Torsten; Ullerich, Hansjörg; Schmedt, Andre; Domagk, Dirk

    2014-09-14

    To develop an algorithm to improve the diagnosis and treatment of patients with biliary candidiasis. We performed a prospective study of 127 patients who underwent endoscopic retrograde cholangiopancreatography, for various biliary disorders, at 3 tertiary referral centers in Germany from July 2011 through July 2012 (ClinicalTrials.gov: NCT01109550). Bile, buccal, and stool samples were collected. When indicated, endoscopic transpapillary bile duct biopsies were performed to clarify the etiology of bile duct strictures and to prove invasive fungal infections. Candida species were detected in 38 of the 127 bile samples (29.9%). By multivariate analysis patients' age and previous endoscopic sphincterotomy were independent risk factors for biliary candidiasis (P 7 d) (P = 0.089) tend to be at risk for biliary candidiasis. One patient was negative in mycological culture of bile fluid but invasive biliary candidiasis was diagnosed histologically. Of Candida subspecies detected, 36.7% were azole-resistant, such as C glabrata. Eight patients received anti-mycotic therapy, based on our algorithm. Of these, 3 had cancer with biliary tract involvement, 2 had secondary sclerosing cholangitis, 1 had retroperitoneal fibrosis, and 5 had septicemia. In all patients contamination was ruled out by smears of the endoscope channel. Gastroenterologists should be aware of frequent candida colonization in patients with cholangitis and biliary disorders. Our suggested algorithm facilitates the further clinical management.

  16. Prospective observational multicenter study to define a diagnostic algorithm for biliary candidiasis

    Science.gov (United States)

    Lenz, Philipp; Eckelskemper, Franziska; Erichsen, Thomas; Lankisch, Tim; Dechêne, Alexander; Lubritz, Gabriele; Lenze, Frank; Beyna, Torsten; Ullerich, Hansjörg; Schmedt, Andre; Domagk, Dirk

    2014-01-01

    AIM: To develop an algorithm to improve the diagnosis and treatment of patients with biliary candidiasis. METHODS: We performed a prospective study of 127 patients who underwent endoscopic retrograde cholangiopancreatography, for various biliary disorders, at 3 tertiary referral centers in Germany from July 2011 through July 2012 (ClinicalTrials.gov: NCT01109550). Bile, buccal, and stool samples were collected. When indicated, endoscopic transpapillary bile duct biopsies were performed to clarify the etiology of bile duct strictures and to prove invasive fungal infections. RESULTS: Candida species were detected in 38 of the 127 bile samples (29.9%). By multivariate analysis patients’ age and previous endoscopic sphincterotomy were independent risk factors for biliary candidiasis (P 7 d) (P = 0.089) tend to be at risk for biliary candidiasis. One patient was negative in mycological culture of bile fluid but invasive biliary candidiasis was diagnosed histologically. Of Candida subspecies detected, 36.7% were azole-resistant, such as C glabrata. Eight patients received anti-mycotic therapy, based on our algorithm. Of these, 3 had cancer with biliary tract involvement, 2 had secondary sclerosing cholangitis, 1 had retroperitoneal fibrosis, and 5 had septicemia. In all patients contamination was ruled out by smears of the endoscope channel. CONCLUSION: Gastroenterologists should be aware of frequent candida colonization in patients with cholangitis and biliary disorders. Our suggested algorithm facilitates the further clinical management. PMID:25232260

  17. Language skills of children during the first 12 months after stuttering onset.

    Science.gov (United States)

    Watts, Amy; Eadie, Patricia; Block, Susan; Mensah, Fiona; Reilly, Sheena

    2017-03-01

    To describe the language development in a sample of young children who stutter during the first 12 months after stuttering onset was reported. Language production was analysed in a sample of 66 children who stuttered (aged 2-4 years). The sample were identified from a pre-existing prospective, community based longitudinal cohort. Data were collected at three time points within the first year after stuttering onset. Stuttering severity was measured, and global indicators of expressive language proficiency (length of utterances and grammatical complexity) were derived from the samples and summarised. Language production abilities of the children who stutter were contrasted with normative data. The majority of children's stuttering was rated as mild in severity, with more than 83% of participants demonstrating very mild or mild stuttering at each of the time points studied. The participants demonstrated developmentally appropriate spoken language skills comparable with available normative data. In the first year following the report of stuttering onset, the language skills of the children who were stuttering progressed in a manner that is consistent with developmental expectations. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. [Hematemesis in Togo: findings of a 12-month study in an intensive care unit].

    Science.gov (United States)

    Djibril, A M; Tomta, K; Balaka, K; Bagny, A; M'ba, K B; Kaaga, L; Redah, D; Agbetra, A

    2010-06-01

    This prospective study was conducted over a 12-month period on patients who underwent upper digestive endoscopy for hematemesis in the medical intensive care unit (ICU) of the Tokoin University Hospital Center in Lomé, Togo. A total of 44 patients with a mean age of 44 years were included. The sex-ratio was 2.61. Risk factors included use of non-steroid anti-inflammatory (NSAI) in 16 patients (36.4%) and alcohol abuse in 13 (29.6%). At the time of admission to the ICU, 21 patients (47.7%) were in hemodynamic shock and 11 (25%) presented signs of portal hypertension. The underlying etiology was peptic ulcer in 18 cases (40.9%) including 13 cases of duodenal ulcer and 5 cases of stomach ulcer, rupture of esophageal varicosities in 8 (18.2%), gastric tumor in 6 (13.6%), Mallory Weiss syndrome in 5 (11.4%), gastritis in 4 (9,1%), and esophagitis in 3 (6.8%) due to peptic inflammation in 2 and mycotic infection in 1. The mortality rate was 45.5%. The main causes of hematemesis were peptic ulcer and rupture of esophageal varicosities. The death rate was high due to inadequate care facilities.

  19. Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893

    International Nuclear Information System (INIS)

    Kim, Hyoung-Il; Hur, Hoon; Kim, Youn Nam; Lee, Hyuk-Joon; Kim, Min-Chan; Han, Sang-Uk; Hyung, Woo Jin

    2014-01-01

    Extended systemic lymphadenectomy (D2) is standard procedure for surgical treatment of advanced gastric cancer (AGC) although less extensive lymphadenectomy (D1) can be applied to early gastric cancer. Complete D2 lymphadenectomy is the mandatory procedure for studies that evaluate surgical treatment results of AGC. However, the actual extent of D2 lymphadenectomy varies among surgeons because of a lacking consensus on the anatomical definition of each lymph node station. This study is aimed to develop a consensus for D2 lymphadenectomy and also to qualify surgeons that can perform both laparoscopic and open D2 gastrectomy. This (KLASS-02-QC) is a prospective, observational, multicenter study to qualify the surgeons that will participate in the KLASS-02-RCT, which is a prospective, randomized, clinical trial comparing laparoscopic and open gastrectomy for AGC. Surgeons and reviewers participating in the study will be required to complete a questionnaire detailing their professional experience and specific gastrectomy surgical background/training, and the gastrectomy metrics of their primary hospitals. All surgeons must submit three laparoscopic and three open D2 gastrectomy videos, respectively. Each video will be allocated to five peer reviewers; thus each surgeon’s operations will be assessed by a total of 30 reviews. Based on blinded assessment of unedited videos by experts’ review, a separate review evaluation committee will decide whether or not the evaluated surgeon will participate in the KLASS-02-RCT. The primary outcome measure is each surgeon’s proficiency, as assessed by the reviewers based on evaluation criteria for completeness of D2 lymphadenectomy. We believe that our study for standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC) will guarantee successful implementation of the subsequent KLASS-02-RCT study. After making consensus on D2 lymphadenectomy, we developed evaluation criteria for completeness of D2

  20. PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

    Science.gov (United States)

    Douglas, Pamela S; Hoffmann, Udo; Lee, Kerry L; Mark, Daniel B; Al-Khalidi, Hussein R; Anstrom, Kevin; Dolor, Rowena J; Kosinski, Andrzej; Krucoff, Mitchell W; Mudrick, Daniel W; Patel, Manesh R; Picard, Michael H; Udelson, James E; Velazquez, Eric J; Cooper, Lawton

    2014-06-01

    Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Copyright © 2014 Mosby, Inc. All rights reserved.

  1. Out-of-pocket fertility patient expense: data from a multicenter prospective infertility cohort.

    Science.gov (United States)

    Wu, Alex K; Odisho, Anobel Y; Washington, Samuel L; Katz, Patricia P; Smith, James F

    2014-02-01

    The high costs of fertility care may deter couples from seeking care. Urologists often are asked about the costs of these treatments. To our knowledge previous studies have not addressed the direct out-of-pocket costs to couples. We characterized these expenses in patients seeking fertility care. Couples were prospectively recruited from 8 community and academic reproductive endocrinology clinics. Each participating couple completed face-to-face or telephone interviews and cost diaries at study enrollment, and 4, 10 and 18 months of care. We determined overall out-of-pocket costs, in addition to relationships between out-of-pocket costs and treatment type, clinical outcomes and socioeconomic characteristics on multivariate linear regression analysis. A total of 332 couples completed cost diaries and had data available on treatment and outcomes. Average age was 36.8 and 35.6 years in men and women, respectively. Of this cohort 19% received noncycle based therapy, 4% used ovulation induction medication only, 22% underwent intrauterine insemination and 55% underwent in vitro fertilization. The median overall out-of-pocket expense was $5,338 (IQR 1,197-19,840). Couples using medication only had the lowest median out-of-pocket expenses at $912 while those using in vitro fertilization had the highest at $19,234. After multivariate adjustment the out-of-pocket expense was not significantly associated with successful pregnancy. On multivariate analysis couples treated with in vitro fertilization spent an average of $15,435 more than those treated with intrauterine insemination. Couples spent about $6,955 for each additional in vitro fertilization cycle. These data provide real-world estimates of out-of-pocket costs, which can be used to help couples plan for expenses that they may incur with treatment. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  2. [Assessing nutritional status of severe malnutrition patients by bioelectrical impedance technique: a multicenter prospective study].

    Science.gov (United States)

    Li, Qiang; Li, Xueni; Leng, Yuxin; Zhu, Xi; Yao, Gaiqi

    2018-02-01

    To assess the nutritional status of severe malnutrition patients with anorexia nervosa by multi-frequency bioelectrical impedance technique, and to provide the basis for nutritional support therapy. A prospective study was conducted. Twenty-six severe malnutrition patients with anorexia nervosa, body mass index (BMI) ≤ 16 kg/m 2 admitted to intensive care unit (ICU) of Peking University Third Hospital and general three ward of Peking University Sixth Hospital from June 1st to September 30th, 2017 were enrolled. The extracellular water (ECW), intracellular water (ICW), ECW/ICW ratio, adipose tissue mass (ATM), lean tissue mass (LTM), total body water/body weight (TBW/WT), ATM/WT, and LTM/WT were measured by multi-frequency bioelectrical impedance meter. Thirty-eighty healthy volunteers with normal nutritional status (23.0 kg/m 2 > BMI > 18.5 kg/m 2 ) matched by gender and height were enrolled as healthy control group. The predictive value of main body composition for nutritional status were analyzed by receiver operating characteristic (ROC) curve. All the patients were female. There was no significant difference in height between two groups, but WT and BMI in the severe malnutrition group were significantly higher than those in the healthy control group [WT (kg): 38.1±4.9 vs. 54.2±3.3, BMI (kg/m 2 ): 13.6±2.5 vs. 21.2±1.1, both P anorexia nervosa changed significantly. Bioelectrical impedance technology can be an effective assessment tool for the nutritional status of such patients.

  3. Socioeconomic deprivation does not influence the severity of Crohn's disease: Results of a prospective multicenter study.

    Science.gov (United States)

    Nahon, Stéphane; Lahmek, Pierre; Macaigne, Gilles; Faurel, Jean-Pierre; Sass, Catherine; Howaizi, Mehran; Fleury, Antoine; Baju, A; Locher, Christophe; Barjonet, Georges; Saillant, GillesGatineau; Moulin, Jean-Jacques; Poupardin, Cécile

    2009-04-01

    Socioeconomic deprivation is associated with poor health. The aims of this study were to evaluate the influence of deprivation in the characteristics and comparisons of deprived and nondeprived Crohn's disease (CD) patients. CD patients were prospectively recruited from September 2006 to June 2007 in 6 hospitals in the Paris area. To assess the level of deprivation we used the EPICES score (Evaluation of Precarity and Inequalities in Health Examination Centers; http://www.cetaf.asso.fr), a validated individual index of deprivation developed in France, a score >30 defining deprivation. We defined CD as severe when at least 1 of the conventionally predefined criteria of clinical severity was present. In all, 207 patients (128 women and 79 men, mean age 40 years) were included and had a median score of deprivation of 20.7 (0-100). Seventy-three (35%) were deprived. There were no statistical differences between deprived and nondeprived patients for the following parameters: 1) mean age: 39 +/- 14.6 versus 40.6 +/- 13.5, P = 0.4; 2) sex ratio (female/male): 87/47 (65%) versus 41/32 (56%), P = 0.2; 3) duration of disease (years) 9 +/- 8.8 versus 8.5 +/- 7.2, P = 0.7; 4) delay from onset of symptoms to diagnosis >1 year: 22/115 (19%) versus 13/63 (21%), P = 0.8; and 5) severity of disease 71% versus 70% (P = 0.9). Nondeprived patients had a lower rate of hospitalization (40 versus 56%, P = 0,04) and a higher rate of surgery (44 versus 22%, P = 0,004); the rate of surgery was only identified by logistic regression. In this study deprivation does not seem to influence the severity of CD. This can be explained by easy access to healthcare in France.

  4. Comparison of scoring systems for nonvariceal upper gastrointestinal bleeding: a multicenter prospective cohort study.

    Science.gov (United States)

    Yang, Hae Min; Jeon, Seong Woo; Jung, Jin Tae; Lee, Dong Wook; Ha, Chang Yoon; Park, Kyung Sik; Lee, Si Hyung; Yang, Chang Heon; Park, Jun Hyung; Park, Youn Sun

    2016-01-01

    The Glasgow-Blatchford score (GBS) and Rockall score (RS) are widely used to assess risk in patients with upper gastrointestinal bleeding (UGIB). We compared both scoring systems and evaluated their clinical usefulness. Between February 2011 and December 2013, 1584 patients with nonvariceal UGIB were included in the study. A prospective study was conducted to compare the performance of the GBS, pre-RS, and full RS. We compared the performance of these scores using receiver operating characteristic curves. For prediction of the need for hospital-based intervention, the GBS was similar to the full RS (area under the receiver operating characteristic curves [AUROC] 0.705 vs 0.727; P = 0.282) and superior to the pre-RS (AUROC 0.705 vs 0.601; P < 0.0001). In predicting death, the full RS was superior to the GBS (AUROC 0.758 vs 0.644; P = 0.0006) and similar to the pre-RS (AUROC 0.758 vs 0.754; P = 0.869). In predicting rebleeding, the full RS was superior to both GBS (AUROC 0.642 vs 0.585; P = 0.031) and pre-RS (AUROC 0.642 vs 0.593; P = 0.0003). Of 1584 patients, 13 (0.8%) scored 0 on the GBS. Therapeutic intervention was not performed in any of these patients. The GBS is more useful than the pre-RS for predicting the need for hospital-based intervention. A cutoff value of 0 for low-risk patients who might be suitable for outpatient management is useful. The full RS is helpful in predicting death. None of the systems accurately predict rebleeding with a low AUROC. ( cris.nih.go.kr/KCT0000514). © 2015 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  5. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine.

    NARCIS (Netherlands)

    Beck, D.E.; Cohen, Z.; Fleshman, J.W.; Kaufman, H.S.; Goor, H. van; Wolff, B.G.

    2003-01-01

    INTRODUCTION: Seprafilm adhesion barrier (Seprafilm) has been proven to prevent adhesion formation after abdominal and pelvic surgery. This article reports safety results, including the postoperative incidence of abdominal and pelvic abscess and pulmonary embolism, from a large, multicenter trial

  6. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI

    Directory of Open Access Journals (Sweden)

    Chuchalin Alexander

    2013-01-01

    Full Text Available Abstract Background Acute exacerbations of chronic bronchitis (AECB, including chronic obstructive pulmonary disease (AECOPD, represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox®, although moxifloxacin is widely approved in this region based on evidence from international clinical studies. Methods AVANTI (AVelox® in Acute Exacerbations of chroNic bronchiTIs was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected. Results In the efficacy population (N = 2536, chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I was 6.4 ± 1.9 days. Symptom improvement was reported after a mean of 3.4 ± 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672, 57 (2.3% patients had treatment-emergent adverse events (TEAEs and 4 (0.15% had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin. Conclusions A significant number of patients in this

  7. ASSESSMENT OF NEURODEVELOPMENTAL OUTCOMES IN INFANTS 6-12 MONTHS OF AGE ACCORDING TO IMPACT OF PERINATAL RISK FACTORS.

    Science.gov (United States)

    Tskimanauri, N; Khachapuridze, N; Imnadze, P; Chanadiri, T; Bakhtadze, S

    2017-12-01

    The purpose of this research was to investigate the developmental follow-up of infants (at age of 6 month and 12 month), exposed to separate and combination impact of perinatal risk factors, compared with not exposed cases, within the prospective cohort study. Between January 2015 and January 2017, in this research we prospectively enrolled 1018 live-born infants from the medical reports of the participating clinics in Tbilisi (capital of Republic of Georgia) and Mtskheta, Dusheti (districts of Georgia). Within postnatal follow-up, the children from whole population were assessed at 6 and 12 months of age by family doctors using the Denver Developmental Screening Test (Denver II). The association between the risk factors and neurodevelopmental outcomes was analyzed by Chi-square test of independence. Statistical analysis of these data was performed using the SPSS version 12. (SPSS Inc., Chicago, IL). A P value of less than 0.05 was considered as significant. Prevalence of abnormal development in whole population was revealed 9.0% or 92 cases at age of 6 month and 36 cases or 3.5% at age of 12 month. Point prevalence of farther neurodevelopmental adversities for healthy born children not influenced by studied risk factors was 0.1% and for infants with impact of the risk factors - 1.5%; on the other hand, prevalence of observed abnormal development in infant's population who had neonatal pathologies was 2.3% if risk factors were not exposed and 21.6% under influence of risk factors. Statistical analysis showed that an abnormal developmental outcomes were more frequent when researched risk factors were exposed (OR-23.18, CI 95% - 11.83 to 45.41 - at age of 6 month; OR - 26.12, CI 95% - 7.95 to 85.85 - at age of 12 month) as well, as correlation of these risk factors with neurodevelopmental adverse outcomes was significant (prisk factors, such as maternal age (35Y), pathologies of pregnancy and delivery as well as gestation age (risk factors increased probability of

  8. Providing reviews of evidence to COPD patients: controlled prospective 12-month trial.

    Science.gov (United States)

    Harris, M; Smith, B J; Veale, A J; Esterman, A; Frith, P A; Selim, P

    2009-01-01

    The aim of this study was to evaluate a novel patient-held manual designed to reduce the evidence-practice gap in chronic obstructive pulmonary disease (COPD). The intervention manual contained summaries of research evidence. It was developed using current best practice for patient information materials and designed to cause discussion of evidence between patient and doctor. A controlled before-and-after study was employed in two similar but geographically separate regions of metropolitan Adelaide, South Australia. Participants had moderate to severe COPD, with 249 included at baseline and 201 completing the study. Evidence-based COPD management was measured using an indicator with three components: rates of influenza vaccination, bone density testing, and pulmonary rehabilitation. A survey of behavioral steps leading to practice change was conducted with the trial. Analysis, by median split of socioeconomic disadvantage, showed significant difference between study arms for only one component of the indicator of evidence-based practice, enrollment in pulmonary rehabilitation and only for the most socioeconomically disadvantaged stratum. For both socioeconomic strata, more intervention participants than control participants reported remembering being given the information material, reading part or all, and finding it very or quite helpful. Other significant differences were restricted to the stratum of greatest socioeconomic disadvantage: reading all of the material, learning from it, referring back, and talking to a doctor about a topic from the material. Above 90% of all participants who received the manual reported reading from it, 42% reported discussing topics with a doctor, but only 10% reported treatment change attributable to the manual. We have found that people with COPD will read an evidence manual developed using current best practice. However, the study demonstrated improvement for only one of the three components of an indicator of evidence-based disease management for only the most socioeconomically disadvantaged stratum of participants. Future interventions should be designed to better translate reading uptake into evidence-based disease management.

  9. Percutaneous Stabilization System Osseofix® for Treatment of Osteoporotic Vertebral Compression Fractures - Clinical and Radiological Results after 12 Months.

    Directory of Open Access Journals (Sweden)

    Stephan Albrecht Ender

    Full Text Available A prospective consecutive cohort study (follow-up study.Our study investigated whether implantation of an expandable titanium mesh cage (Osseofix® is a successful and safe minimally invasive therapy for osteoporotic vertebral compression fractures (VCF. Our experiences, clinical and radiological findings after 12 months follow-up are presented. Kypho- and vertebroplasty are well-established minimally invasive procedures for the treatment of osteoporotic VCF. The main complications associated with both procedures are uncontrolled bone cement leakage. Therefore a suitable alternative has been investigated.During June 2010 to May 2011 24 patients were included with 32 osteoporotic VCF (T6 to L4. All of them were stabilized with the Osseofix® system. Preinterventionally we performed X-ray, MRI, and bone density measurements (DXA. Clinical and radiological results were evaluated preop., postop. and after 12 months postop. based on the Oswestry Disability Index (ODI and the Visual Analogue Scale (VAS, X-ray (Beck Index, Cobb-angle and CT.There was a significant improvement in the mean ODI (70,6% to 30,1% as well as a significant reduction in pain intensity (VAS (7,7 to 1,4 after 12 month. The mean kyphotic angle according to Cobb showed significant improvements (11,7° to 10,4° after 12 months. Postinterventional imaging showed only one case of loss of height in a stabilized vertebral body (3.1%. We saw no changes in posterior vertebral wall or adjacent fractures. Except for one pronounced postoperative hematoma we saw no surgical complications including no cement leakage.Stabilization of symptomatic osteoporotic VCF with Osseofix® system is a safe and effective procedure, even in fractures with posterior wall involvement. The clinical mid-term results are good at a very low complication rate. The Osseofix® system is an interesting alternative to the established procedures of cement augmentation.

  10. Evaluation of a prospective scoring system designed for a multicenter breast MR imaging screening study.

    Science.gov (United States)

    Warren, Ruth M L; Thompson, Deborah; Pointon, Linda J; Hoff, Rebecca; Gilbert, Fiona J; Padhani, Anwar R; Easton, Douglas F; Lakhani, Sunil R; Leach, Martin O

    2006-06-01

    To evaluate prospectively the accuracy of a lesion classification system designed for use in a magnetic resonance (MR) imaging high-breast-cancer-risk screening study. All participating patients provided written informed consent. Ethics committee approval was obtained. The results of 1541 contrast material-enhanced breast MR imaging examinations were analyzed; 1441 screening examinations were performed in 638 women aged 24-51 years at high risk for breast cancer, and 100 examinations were performed in 100 women aged 23-81 years. Lesion analysis was performed in 991 breasts, which were divided into design (491 breasts) and testing (500 breasts) sets. The reference standard was histologic analysis of biopsy samples, fine-needle aspiration cytology, or minimal follow-up of 24 months. The scoring system involved the use of five features: morphology (MOR), pattern of enhancement (POE), percentage of maximal focal enhancement (PMFE), maximal signal intensity-time ratio (MITR), and pattern of contrast material washout (POCW). The system was evaluated by means of (a) assessment of interreader agreement, as expressed in kappa statistics, for 315 breasts in which both readers analyzed the same lesion, (b) assessment of the diagnostic accuracy of the scored components with receiver operating characteristic curve analysis, and (c) logistic regression analysis to determine which components of the scoring system were critical to the final score. A new simplified scoring system developed with the design set was applied to the testing set. There was moderate reader agreement regarding overall lesion outcome (ie, malignant, suspicious, or benign) (kappa=0.58) and less agreement regarding the scored components. The area under the receiver operating characteristic curve (AUC) for the overall lesion score, 0.88, was higher than the AUC for any one component. The components MOR, POE, and POCW yielded the best overall result. PMFE and MITR did not contribute to diagnostic utility

  11. Baseline Shoulder Ultrasonography Is Not a Predictive Marker of Response to Glucocorticoids in Patients with Polymyalgia Rheumatica: A 12-month Followup Study.

    Science.gov (United States)

    Miceli, Maria Concetta; Zoli, Angelo; Peluso, Giusy; Bosello, Silvia; Gremese, Elisa; Ferraccioli, Gianfranco

    2017-02-01

    In this study, we evaluated whether ultrasound (US) subdeltoid bursitis (SB) and/or biceps tenosynovitis (BT) presence at baseline could represent a predictive marker of response to standard therapy after 12 months of followup, and whether a positive US examination could highlight the need of higher maintenance dosage of glucocorticoids (GC) at 6 and 12 months in patients with polymyalgia rheumatica (PMR). Sixty-six consecutive patients with PMR underwent bilateral shoulder US evaluations before starting therapy and after 12 months of followup. Absence of girdle pain and morning stiffness (clinical remission) and laboratory variables were evaluated. After diagnosis, all patients were treated with prednisone. At baseline, SB and/or BT were present in 46 patients (70%), of whom 33 (72%) became negative while 13 (28%) remained positive at the 12-month US evaluation. All patients rapidly achieved a clinical remission, and at 6 months 26 (39%) also achieved a laboratory variable normalization. According to US positivity at baseline, no difference was found in remission or relapse rate after 12 months. Thirty patients (46%) at 6 months and 7 (11%) at 12 months were still taking more than 5 mg/day of prednisone. According to the US pattern at baseline, no difference was found in the mean GC dose at 6 and 12 months. In patients with PMR, the presence of SB and/or BT on US at diagnosis is not a predictive marker of GC response or of a higher GC dosage to maintain remission in a 12-month prospective followup study.

  12. Axial Globe Position Measurement: A Prospective Multi-center Study by the International Thyroid Eye Disease Society

    Science.gov (United States)

    Bingham, Chad M.; Sivak-Callcott, Jennifer A.; Gurka, Matthew J.; Nguyen, John; Hogg, Jeffery P.; Feldon, Steve E.; Fay, Aaron; Seah, Lay-Leng; Strianese, Diego; Durairaj, Vikram D.; Uddin, Jimmy; Devoto, Martin H.; Harris, Matheson; Saunders, Justin; Osaki, Tammy H.; Looi, Audrey; Teo, Livia; Davies, Brett W.; Elefante, Andrea; Shen, Sunny; Realini, Tony; Fischer, William; Kazim, Michael

    2015-01-01

    Purpose Identify a reproducible measure of axial globe position (AGP) for multicenter studies of patients with thyroid eye disease (TED). Methods This is a prospective, international, multicenter, observational study in which 3 types of AGP evaluation were examined: radiologic, clinical, and photographic. In this study, computed tomography (CT) was the modality to which all other methods were compared. CT AGP was measured from an orthogonal line between the anterior lateral orbital rims to the cornea. All CT measurements were made at a single institution by 3 individual clinicians. Clinical evaluation was performed with exophthalmometry. Three clinicians from each clinical site assessed AGP with 3 different exophthalmometers and horizontal palpebral width using a ruler. Each physician made 3 separate measurements with each type of exophthalmometer, not in succession. All photographic measurements were made at a single institution. AGP was measured from lateral photographs in which a standard marker was placed at the anterior lateral orbital rim. Horizontal and vertical palpebral fissure were measured from frontal photographs. Three trained readers measured 3 separate times, not in succession. Exophthalmometry and photography method validity was assessed by agreement with CT (mean differences calculation, ICC’s, Bland-Altman figures). Correlation between palpebral fissure and CT AGP was assessed with Pearson correlation. Intraclinician and interclinician reliability was evaluated using intraclass correlation coefficients (ICC). Results Sixty-eight patients from 7 centers participated. CT mean AGP was 21.37mm (15.96 – 28.90mm) right, 21.22mm (15.87 – 28.70mm) left (ICC 0.996 and 0.995). Exophthalmometry AGP fell between 18mm and 25mm. Intraclinician agreement across exophthalmometers was ideal (ICC 0.948 – 0.983). Agreement between clinicians was greater than 0.85 for all upright exophthalmometry measurements. Photographic mean AGP was 20.47mm (10.92 – 30

  13. Associations with legal representation in a compensation setting 12 months after injury.

    Science.gov (United States)

    Casey, Petrina P; Feyer, Anne Marie; Cameron, Ian D

    2015-05-01

    Many people with Whiplash Associated Disorder (WAD) seek treatment though a compensation system where factors such as legal involvement have been reported as having a negative impact on recovery outcomes. To compare those with and without legal involvement in their compensation claim, and identify associations with legal involvement at 12 months post injury; and longer term disability. Inception cohort study. 246 people with WAD compensation claim. Legal involvement and Functional Rating Index at 12 months post injury. Participants were recruited from an insurance database. Baseline health (Functional Rating Index, Pain Catastrophising Scale and SF-36), socio-economic, work capacity, and claims data were collected within three months of injury and 12 months. Logistic regression models were used to identify associations with legal involvement at 12 months; and disability (FRI) at 12 months. At baseline 246 participants were enrolled into the study in a median 72 days post injury. At 12 months post injury 52 (25%) had engaged a lawyer. The significant independent associations with legal involvement at 12 months were higher levels of initial disability, work disability, speaking a language other than English at home and lower levels of mental health. Specifically, the odds of lawyer involvement at 12 months post injury was 4.9 times greater for those with work disability; 2.3 times greater for those who spoke a language other than English at home. In terms of health, they had poorer mental health and for every 10 unit increase in the baseline FRI score the odds of having lawyer involvement increased by 38%. DISABILITY: at 12 months (FRI) was significantly independently associated with, PCS-helplessness (pdisadvantage, have had a prior claim and a worse baseline health profile compared to those without a lawyer. Understanding this profile could allow for improved claims processes and targeted interventions to assist this group through any perceived complexities in the

  14. Accuracy of a Computer-Aided Surgical Simulation (CASS) Protocol for Orthognathic Surgery: A Prospective Multicenter Study

    Science.gov (United States)

    Hsu, Sam Sheng-Pin; Gateno, Jaime; Bell, R. Bryan; Hirsch, David L.; Markiewicz, Michael R.; Teichgraeber, John F.; Zhou, Xiaobo; Xia, James J.

    2012-01-01

    Purpose The purpose of this prospective multicenter study was to assess the accuracy of a computer-aided surgical simulation (CASS) protocol for orthognathic surgery. Materials and Methods The accuracy of the CASS protocol was assessed by comparing planned and postoperative outcomes of 65 consecutive patients enrolled from 3 centers. Computer-generated surgical splints were used for all patients. For the genioplasty, one center utilized computer-generated chin templates to reposition the chin segment only for patients with asymmetry. Standard intraoperative measurements were utilized without the chin templates for the remaining patients. The primary outcome measurements were linear and angular differences for the maxilla, mandible and chin when the planned and postoperative models were registered at the cranium. The secondary outcome measurements were: maxillary dental midline difference between the planned and postoperative positions; and linear and angular differences of the chin segment between the groups with and without the use of the template. The latter was measured when the planned and postoperative models were registered at mandibular body. Statistical analyses were performed, and the accuracy was reported using root mean square deviation (RMSD) and Bland and Altman's method for assessing measurement agreement. Results In the primary outcome measurements, there was no statistically significant difference among the 3 centers for the maxilla and mandible. The largest RMSD was 1.0mm and 1.5° for the maxilla, and 1.1mm and 1.8° for the mandible. For the chin, there was a statistically significant difference between the groups with and without the use of the chin template. The chin template group showed excellent accuracy with largest positional RMSD of 1.0mm and the largest orientational RSMD of 2.2°. However, larger variances were observed in the group not using the chin template. This was significant in anteroposterior and superoinferior directions, as in

  15. TRREMS procedure (transanal repair of rectocele and rectal mucosectomy with one circular stapler: a prospective multicenter trial

    Directory of Open Access Journals (Sweden)

    José Vinicius Cruz

    2011-03-01

    Full Text Available CONTEXT: Since anorectocele is usually associated with mucosa prolapse and/or rectal intussusceptions, it was developed a stapled surgical technique using one circular stapler. OBJECTIVE: To report the results of Transanal Repair of Rectocele and Rectal Mucosectomy with one Circular Stapler (TRREMS procedure in the treatment of anorectocele with mucosa prolapse in a prospective multicenter trial. METHODS: It was conducted by 14 surgeons and included 75 female patients, mean aged 49.6 years, with symptoms of obstructed defecation due to grade 2 (26.7% and grade 3 (73.3% anorectocele associated with mucosa prolapse and/or rectal intussusception (52.0% and an average validated Wexner constipation score of 16. All patients were evaluated by a proctological examination, cinedefecography, anal manometry and colonic transit time. The TRREMS procedure consists of the manual removal of the rectocele wall with circumferential rectal mucosectomy performed with a circular stapler. The mean follow-up time was 21 months. RESULTS: All patients presented obstructed defecation and they persisted with symptoms despite conservative treatment. The mean operative time was 42 minutes. In 13 (17.3% patients, bleeding from the stapled line required hemostatic suture. Stapling was incomplete in 2 (2.6%. Forty-nine patients (65.3% required 1 hospitalization day, the remainder (34.7% 2 days. Postoperatively, 3 (4.0% patients complained of persistent rectal pain and 7 (9.3% developed stricture on the stapled suture subsequently treated by stricturectomy under anesthesia (n = 1, endoscopic stricturectomy with hot biopsy forceps (n = 3 and digital dilatation (n = 3. Postoperative cinedefecography showed residual grade I anorectoceles in 8 (10.6%. The mean Wexner constipation score decreased significantly from 16 to 4 (0-4: n = 68 (6: n = 6 (7: n = 1 (P<0.0001. CONCLUSION: Current trial results suggest that TRREMS procedure is a safe and effective technique for the treatment

  16. Omega-3 fatty acid supplementation improves dry eye symptoms in patients with glaucoma: results of a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    Tellez-Vazquez J

    2016-04-01

    Full Text Available Jesús Tellez-Vazquez On behalf of the Dry Eye In Glaucoma Study Group (DEIGSG Glaucoma Section, Ophthalmology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain Purpose: The purpose of this study is to assess the effectiveness and tolerability of a dietary supplement with a combination of omega-3 fatty acids and antioxidants on dry eye symptoms caused by chronic instillation of antihypertensive eye drops in patients with glaucoma. Patients and methods: A total of 1,255 patients with glaucoma and dry eye symptoms related to antiglaucoma topical medication participated in an open-label, uncontrolled, prospective, and multicenter study and were instructed to take three capsules a day of the nutraceutical formulation (Brudypio® 1.5 g for 12 weeks. Dry eye symptoms (graded as 0–3 [none to severe, respectively], conjunctival hyperemia, tear breakup time, Schirmer I test, Oxford grading scheme, and intraocular pressure were assessed. Results: After 12 weeks of administration of the dietary supplement, all dry eye symptoms improved significantly (P<0.001 (mean 1.3 vs 0.6 for scratching, 1.4 vs 0.7 for stinging sensation, 1.6 vs 0.7 for grittiness, 1.0 vs 0.4 for tired eyes, 1.1 vs 0.5 for grating sensation, and 0.8 vs 0.3 for blurry vision. The Schirmer test scores and the tear breakup time also increased significantly. There was an increase in the percentage of patients grading 0–I in the Oxford scale and a decrease in those grading IV–V. Compliance was recorded in 62.5% of patients. In compliant patients, the mean differences at 12 weeks vs baseline of dry eye symptoms were statistically significant as compared to noncompliant patients. Conclusion: Dietary supplementation with Brudypio® may be a clinically valuable additional option for the treatment of dry eye syndrome in patients with glaucoma using antiglaucoma eye drops. These results require confirmation with an appropriately designed randomized controlled study

  17. Analysis of Inappropriate Admissions of Residents of Medicalized Nursing Homes to Emergency Departments: A Prospective Multicenter Study in Burgundy.

    Science.gov (United States)

    Manckoundia, Patrick; Menu, Didier; Turcu, Alin; Honnart, Didier; Rossignol, Sylvie; Alixant, Jean-Christophe; Sylvestre, Franck-Henry; Bailly, Vanessa; Dion, Michèle; Putot, Alain

    2016-07-01

    To determine the rate of inappropriate admissions to emergency departments (EDs) and to identify determinants of these admissions. Prospective multicenter study. Burgundy (France), EDs and medical nursing homes (MNHs). 1000 Burgundy MNH residents admitted to EDs, from April 17 to June 20, 2013. For each subject, a questionnaire was completed. Data included age, gender, type of health professional who referred the resident to the ED (THP), whether or not a medical dispatcher organized the transfer to the ED, transport mode, reason for admission to the ED, level of independence according to the Groupes Iso-Ressource score (GIRS), and diagnosis made in the ED. The French version of the Appropriateness Evaluation Protocol grid was applied to each admission to the ED, and in some situations, the expert committee ruled on the appropriateness of the admission to the ED. MNH characteristics were also recorded. Two groups were constituted according to the appropriateness or not of admission to the ED. Mean age of the 1000 residents was 87. There were 706 women. Two-thirds were referred to the EDs by a physician, mainly a general practitioner. In 91.7%, the transfer to the ED was organized by a medical dispatcher, and 8.8% were transported by medicalized transport. More than 95% had a GIRS ≤4. Among the admissions to EDs, 18.1% were inappropriate. Female gender (P = .017), nonmedicalized transport (P = .002), public MNH (P = .044), and nonaccess to a geriatric opinion in an emergency (P = .043) were determinants of inappropriate admission to EDs. In this first study on admissions to EDs of MNH residents using French data, we found a lower rate of admissions to the ED than that reported in the literature. Female gender, nonmedicalized transport, public MNH, and nonaccess to a geriatric opinion in an emergency were associated with inappropriate admission to EDs. Copyright © 2016 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier

  18. Epidemiology and outcomes of acute respiratory distress syndrome in children according to the Berlin definition: a multicenter prospective study.

    Science.gov (United States)

    Barreira, Eliane R; Munoz, Gabriela O C; Cavalheiro, Priscilla O; Suzuki, Adriana S; Degaspare, Natalia V; Shieh, Huei H; Martines, João A D S; Ferreira, Juliana C; Lane, Christianne; Carvalho, Werther B; Gilio, Alfredo E; Precioso, Alexander R

    2015-05-01

    In 2012, a new acute respiratory distress syndrome definition was proposed for adult patients. It was later validated for infants and toddlers. Our objective was to evaluate the prevalence, outcomes, and risk factors associated with acute respiratory distress syndrome in children up to 15 years according to the Berlin definition. A prospective, multicenter observational study from March to September 2013. Seventy-seven PICU beds in eight centers: two private hospitals and six public academic hospitals in Brazil. All children aged 1 month to 15 years admitted to the participating PICUs in the study period. None. All children admitted to the PICUs were daily evaluated for the presence of acute respiratory distress syndrome according to the American-European Consensus Conference and Berlin definitions. Of the 562 patients included, acute respiratory distress syndrome developed in 57 patients (10%) and 58 patients (10.3%) according to the Berlin definition and the American-European Consensus Conference definition, respectively. Among patients with acute respiratory distress syndrome according to the Berlin definition, nine patients (16%) were mild, 21 (37%) were moderate, and 27 (47%) were severe. Compared with patients without acute respiratory distress syndrome, patients with acute respiratory distress syndrome had significantly higher severity scores, longer PICU and hospital length of stay, longer duration of mechanical ventilation, and higher mortality (p < 0.001). The presence of two or more comorbidities and admission for medical reasons were associated with development of acute respiratory distress syndrome. Comparisons across the three the Berlin categories showed significant differences in the number of ventilator-free days (21, 20, and 5 d, p = 0.001) and mortality for severe acute respiratory distress syndrome (41%) in comparison with mild (0) and moderate (15%) acute respiratory distress syndrome(p = 0.02). No differences in PICU or hospital stay were

  19. Portable Video Media Versus Standard Verbal Communication in Surgical Information Delivery to Nurses: A Prospective Multicenter, Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Kam, Jonathan; Ainsworth, Hannah; Handmer, Marcus; Louie-Johnsun, Mark; Winter, Matthew

    2016-10-01

    Continuing education of health professionals is important for delivery of quality health care. Surgical nurses are often required to understand surgical procedures. Nurses need to be aware of the expected outcomes and recognize potential complications of such procedures during their daily work. Traditional educational methods, such as conferences and tutorials or informal education at the bedside, have many drawbacks for delivery of this information in a universal, standardized, and timely manner. The rapid uptake of portable media devices makes portable video media (PVM) a potential alternative to current educational methods. To compare PVM to standard verbal communication (SVC) for surgical information delivery and educational training for nurses and evaluate its impact on knowledge acquisition and participant satisfaction. Prospective, multicenter, randomized controlled crossover trial. Two hospitals: Gosford District Hospital and Wyong Hospital. Seventy-two nursing staff (36 at each site). Information delivery via PVM--7-minute video compared to information delivered via SVC. Knowledge acquisition was measured by a 32-point questionnaire, and satisfaction with the method of education delivery was measured using the validated Client Satisfaction Questionnaire (CSQ-8). Knowledge acquisition was higher via PVM compared to SVC 25.9 (95% confidence interval [CI] 25.2-26.6) versus 24.3 (95% CI 23.5-25.1), p = .004. Participant satisfaction was higher with PVM 29.5 (95% CI 28.3-30.7) versus 26.5 (95% CI 25.1-27.9), p = .003. Following information delivery via SVC, participants had a 6% increase in knowledge scores, 24.3 (95% CI 23.5-25.1) versus 25.7 (95% CI 24.9-26.5) p = .001, and a 13% increase in satisfaction scores, 26.5 (95% CI 25.1-27.9) versus 29.9 (95% CI 28.8-31.0) p < .001, when they crossed-over to information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the

  20. Prospective multicenter trial comparing echodefecography with defecography in the assessment of anorectal dysfunction in patients with obstructed defecation.

    Science.gov (United States)

    Regadas, F Sergio P; Haas, Eric M; Abbas, Maher A; Marcio Jorge, J; Habr-Gama, Angelita; Sands, Dana; Wexner, Steven D; Melo-Amaral, Ingrid; Sardiñas, Carlos; Lima, Doryane M; Sagae, Univaldo E; Sagae, Evaldo U; Murad-Regadas, Sthela M

    2011-06-01

    Defecography is the gold standard for assessing functional anorectal disorders but is limited by the need for a specific radiologic environment, exposure of patients to radiation, and inability to show all anatomic structures involved in defecation. Echodefecography is a 3-dimensional dynamic ultrasound technique developed to overcome these limitations. This study was designed to validate the effectiveness of echodefecography compared with defecography in the assessment of anorectal dysfunctions related to obstructed defecation. Multicenter, prospective observational study. Women with symptoms of obstructed defecation. Six centers for colorectal surgery (3 in Brazil, 1 in Texas, 1 in Florida, and 1 in Venezuela). Defecography was performed after inserting 150 mL of barium paste in the rectum. Echodefecography was performed with a 2050 endoprobe through 3 automatic scans. The κ statistic was used to assess agreement between echodefecography and defecography in the evaluation of rectocele, intussusception, anismus, and grade III enterocele. Eighty-six women were evaluated: median Wexner constipation score, 13.4 (range, 6-23); median age, 53.4 (range, 26-77) years. Rectocele was identified with substantial agreement between the 2 methods (defecography, 80 patients; echodefecography, 76 patients; κ = 0.61; 95% CI = 0.48-0.73). The 2 techniques demonstrated identical findings in 6 patients without rectocele, and in 9 patients with grade I, 29 with grade II, and 19 patients with grade III rectoceles. Defecography identified rectal intussusception in 42 patients, with echodefecography identifying 37 of these cases, plus 4 additional cases, yielding substantial agreement (κ = 0.79; 95% CI = 0.57-1.0). Intussusception was associated with rectocele in 28 patients for both methods (κ = 0.62; 95% CI = 0.41-0.83). There was substantial agreement for anismus (κ = 0.61; 95% CI = 0.40-0.81) and for rectocele combined with anismus (κ = 0.61; 95% CI = 0.40-0.82). Agreement for

  1. Ethical validity of palliative sedation therapy: a multicenter, prospective, observational study conducted on specialized palliative care units in Japan.

    Science.gov (United States)

    Morita, Tatsuya; Chinone, Yoshikazu; Ikenaga, Masayuki; Miyoshi, Makoto; Nakaho, Toshimichi; Nishitateno, Kenji; Sakonji, Mitsuaki; Shima, Yasuo; Suenaga, Kazuyuki; Takigawa, Chizuko; Kohara, Hiroyuki; Tani, Kazuhiko; Kawamura, Yasuo; Matsubara, Tatsuhiro; Watanabe, Akihiko; Yagi, Yasuo; Sasaki, Toru; Higuchi, Akiko; Kimura, Hideyuki; Abo, Hirofumi; Ozawa, Taketoshi; Kizawa, Yoshiyuki; Uchitomi, Yosuke

    2005-10-01

    Although palliative sedation therapy is often required in terminally ill cancer patients to achieve acceptable symptom relief, empirical data supporting the ethical validity of this approach are lacking. The primary aim of this study was to systematically investigate whether empirical evidence supports the ethical validity of sedation. This was a multicenter, prospective, observational study, which was conducted by 21 specialized palliative care units in Japan. One-hundred two consecutive adult cancer patients who received continuous deep sedation were enrolled. Continuous deep sedation was defined as the continuous use of sedative medications to relieve intolerable and refractory distress by achieving almost or complete unconsciousness until death. Prior to the study, we conceptualized the ethical validity of sedation from the viewpoints of physicians' intent, proportionality, and autonomy. Sedation was performed mainly with midazolam and phenobarbital. The initial doses of midazolam and phenobarbital were 1.5 mg/hour and 20 mg/hour, respectively. Main administration routes were continuous subcutaneous infusion and continuous intravenous infusion, and no rapid intravenous injection was reported. Of 59 patients who received artificial hydration or could intake adequate fluids/foods orally before sedation, 63% received artificial hydration therapy after sedation, and in the remaining patients, artificial hydration was withheld or withdrawn due to fluid retention symptoms and/or patient wishes. Of 66 patients who were able to verbally express themselves, 95% explicitly stated that symptoms were intolerable. The etiologies of the symptoms requiring sedation were primarily related to the progression of the underlying malignancy, such as cancer cachexia and organ failure, and standard palliative treatments had failed: steroids in 68% of patients with fatigue, opioids in 95% of patients with dyspnea, antisecretion medications in 75% of patients with bronchial secretion

  2. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study).

    Science.gov (United States)

    Starling, Amaal J; Tepper, Stewart J; Marmura, Michael J; Shamim, Ejaz A; Robbins, Matthew S; Hindiyeh, Nada; Charles, Andrew C; Goadsby, Peter J; Lipton, Richard B; Silberstein, Stephen D; Gelfand, Amy A; Chiacchierini, Richard P; Dodick, David W

    2018-05-01

    Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a -2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (-0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of -2

  3. Prognostic Value of Coronary Artery Calcium in the PROMISE Study (Prospective Multicenter Imaging Study for Evaluation of Chest Pain).

    Science.gov (United States)

    Budoff, Matthew J; Mayrhofer, Thomas; Ferencik, Maros; Bittner, Daniel; Lee, Kerry L; Lu, Michael T; Coles, Adrian; Jang, James; Krishnam, Mayil; Douglas, Pamela S; Hoffmann, Udo

    2017-11-21

    Coronary artery calcium (CAC) is an established predictor of future major adverse atherosclerotic cardiovascular events in asymptomatic individuals. However, limited data exist as to how CAC compares with functional testing (FT) in estimating prognosis in symptomatic patients. In the PROMISE trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain), patients with stable chest pain (or dyspnea) and intermediate pretest probability for obstructive coronary artery disease were randomized to FT (exercise electrocardiography, nuclear stress, or stress echocardiography) or anatomic testing. We evaluated those who underwent CAC testing as part of the anatomic evaluation (n=4209) and compared that with results of FT (n=4602). We stratified CAC and FT results as normal or mildly, moderately, or severely abnormal (for CAC: 0, 1-99 Agatston score [AS], 100-400 AS, and >400 AS, respectively; for FT: normal, mild=late positive treadmill, moderate=early positive treadmill or single-vessel ischemia, and severe=large ischemic region abnormality). The primary end point was all-cause death, myocardial infarction, or unstable angina hospitalization over a median follow-up of 26.1 months. Cox regression models were used to calculate hazard ratios (HRs) and C statistics to determine predictive and discriminatory values. Overall, the distribution of normal or mildly, moderately, or severely abnormal test results was significantly different between FT and CAC (FT: normal, n=3588 [78.0%]; mild, n=432 [9.4%]; moderate, n=217 [4.7%]; severe, n=365 [7.9%]; CAC: normal, n=1457 [34.6%]; mild, n=1340 [31.8%]; moderate, n=772 [18.3%]; severe, n=640 [15.2%]; P 0), whereas fewer than half of events occurred in patients with mildly, moderately, or severely abnormal FT (n=57 of 132, 43%; P fair for both CAC and FT (C statistic, 0.67 versus 0.64). Coronary computed tomographic angiography provided significantly better prognostic information compared with FT and CAC testing (C index

  4. The 6-F nitinol TrapEase inferior vena cava filter: results of a prospective multicenter trial.

    Science.gov (United States)

    Rousseau, H; Perreault, P; Otal, P; Stockx, L; Golzarian, J; Oliva, V; Reynaud, P; Raat, F; Szatmari, F; Santoro, G; Emanuelli, G; Nonent, M; Hoogeveen, Y

    2001-03-01

    The authors report the first results of a new 6-F symmetrically designed permanent nitinol inferior vena cava (IVC) filter, the Cordis TrapEase, evaluated in a multicenter prospective study with 6-months of follow-up. A total of 65 patients (29 men, 36 women) who ranged in age from 37 to 96 years (mean age, 68 years) and who were at high risk of pulmonary embolism (PE) were enrolled in 12 centers in Europe and Canada. The study was approved by the institutional review boards at all centers. Study objectives were to evaluate filter effectiveness, filter stability, and caval occlusion. Indications for filter placement were deep vein thrombosis with recurrent thromboembolism and/or free-floating thrombus with contraindication to anticoagulation in 37 patients, and complications in achieving adequate anticoagulation in 28 patients. Follow-up included clinical examination, plain film, Doppler ultrasound, CT scan, and nuclear medicine. The analysis of the data revealed a technical success of 95.4% (three filter-system related implantations not at the intended site, no events of filter tilting) and a clinical success of 100% at 6 months (no cases of symptomatic PE), the study primary endpoint. There were no cases (0%) of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study period, there were two cases of filter thrombosis: one case of early symptomatic thrombosis that was successfully treated in the hospital, and one case of nonsymptomatic filter thrombosis detected at 1-month follow-up, with spontaneous recanalization at 3 months. In the latter patient, some residual thrombus was still detected at 6 months. Of the study population of 65 patients, there were 23 deaths. These deaths were not related to the device or the implantation procedure but to the underlying disease process. This study demonstrates the new nitinol permanent IVC filter to be a safe and an effective device, with a low overall complication rate, for

  5. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    Directory of Open Access Journals (Sweden)

    Shah K

    2017-05-01

    Full Text Available Kshitij Shah,1 Omvijay B Chaudhari,2 Palash Gupta,3 R Hom Chaudhuri,4 Ranjan Kamilya,5 Shreedhar S Kulkarni,6 S Subbaiah,7 Zubair H Sorathia,8 Gauri Billa9 1MS Orthopedic, Prime Hospital, Andheri (West, 2Vatsalya Nursing Home, Kalyan (West, Mumbai, 3Dr. Palash Gupta Clinic, Rohini, New Delhi, 4Homchaudhuri’s Clinic, 5Apollo Gleneagles Hospital, Kolkata, West Bengal, 6Amrit Clinic, Matunga, Mumbai, 7Subbaiah’s Clinic, West Mambalam, Chennai, 8Medicare Hospital, Marol, Andheri East, 9Medical Services, Abbott Healthcare Pvt. Ltd, Mulund (West, Mumbai, Maharashtra, India Objective: To assess the effectiveness, overall tolerability, and gastrointestinal (GI tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg] in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods: In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at baseline, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results: A total of 351 patients (mean age 44.2 years; male 43%; female 57% were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001. The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 % patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients

  6. Dry Eye Disease following Refractive Surgery: A 12-Month Follow-Up of SMILE versus FS-LASIK in High Myopia

    Science.gov (United States)

    Wang, Bingjie; Chu, Renyuan; Dai, Jinhui; Qu, Xiaomei; Zhou, Hao

    2015-01-01

    Purpose. To compare dry eye disease following SMILE versus FS-LASIK. Design. Prospective, nonrandomised, observational study. Patients. 90 patients undergoing refractive surgery for myopia were included. 47 eyes underwent SMILE and 43 eyes underwent FS-LASIK. Methods. Evaluation of dry eye disease was conducted preoperatively and at 1, 3, 6, and 12 months postoperatively, using the Salisbury Eye Evaluation Questionnaire (SEEQ) and TBUT. Results. TBUT reduced following SMILE at 1 and 3 months (p dry eye disease than FS-LASIK at 6 months postoperatively but demonstrates similar degrees of dry eye disease at 12 months. PMID:26649190

  7. The South African Stress and Health (SASH) study: 12- month and ...

    African Journals Online (AJOL)

    scale population-based study of common mental disorders in the country. This paper provides data on the 12-month and lifetime prevalence of these conditions. Methods. Data from a nationally representative sample of 4 351 adults were ...

  8. Unexpected Arrest-Related Deaths in America: 12 Months of Open Source Surveillance

    Directory of Open Access Journals (Sweden)

    Ho, Jeffrey D

    2009-05-01

    Full Text Available Introduction: Sudden, unexpected arrest-related death (ARD has been associated with drug abuse, extreme delirium or certain police practices. There is insufficient surveillance and causation data available. We report 12 months of surveillance data using a novel data collection methodology.Methods: We used an open-source, prospective method to collect 12 consecutive months of data, including demographics, behavior, illicit substance use, control methods used, and time of collapse after law enforcement contact. Descriptive analysis and chi-square testing were applied.Results: There were 162 ARD events reported that met inclusion criteria. The majority were male with mean age 36 years, and involved bizarre, agitated behavior and reports of drug abuse just prior to death. Law enforcement control techniques included none (14%; empty-hand techniques (69%; intermediate weapons such as TASER device, impact weapon or chemical irritant spray (52%; and deadly force (12%. Time from contact to subject collapse included instantaneous (13%, within the first hour (53% and 1-48 hours (35%. Significant collapse time associations occurred with the use of certain intermediate weapons.Conclusion: This surveillance report can be a foundation for discussing ARD. These data support the premise that ARDs primarily occur in persons with a certain demographic and behavior profile that includes middle-aged males exhibiting agitated, bizarre behavior generally following illicit drug abuse. Collapse time associations were demonstrated with the use of TASER devices and impact weapons. We recommend further study in this area to validate our data collection method and findings. [WestJEM. 2009;10:68-73.

  9. Frequency of cardiovascular risk factors before and 6 and 12 months after bariatric surgery.

    Science.gov (United States)

    Silva, Maria Alayde Mendonça da; Rivera, Ivan Romero; Barbosa, Emília Maria Wanderley de Gusmão; Crispim, Maria Angélica Correia; Farias, Guilherme Costa; Fontan, Alberto Jorge Albuquerque; Bezerra, Rodrigo Azavedo; Sá, Larissa Gabriella de Souza

    2013-01-01

    To compare the frequency of cardiovascular risk factors (CVRFs) in obese patients of the Brazilian Unified Health System (Sistema Único de Saúde - SUS) with indication of bariatric surgery during the preoperative period and after the sixth month and the first year of the procedure. An observational, longitudinal, prospective, and analytical study was performed, with consecutive selection of obese patients with indication for surgery referred to preoperative cardiac evaluation. The protocol consisted of: medical history, physical examination, electrocardiogram, echocardiogram, and biochemical analysis. This study analyzed the following variables: weight, body mass index (BMI), waist circumference (WC), systemic arterial hypertension (SAH), diabetes mellitus type 2(DM), dyslipidemia (high LDL cholesterol; low HDL cholesterol; hypertriglyceridemia), and metabolic syndrome (MS). The chi-squared test and the Tukey-Kramer method were used for statistical analysis. The sample was composed of 96 obese people, among which 86 were women, aged between 18 and 58 years old (median 35 years old). At the end of six months, significant reductions of 88%, 95%, 71%, 89%, and 80% in the frequency of SAH, high LDL cholesterol, hypertriglyceridemia, DM, and MS could already be observed. A significant and small reduction in the frequency of low HDL cholesterol (24%) and abnormal WC (31%) was observed only at the end of 12 months. After six months and one year, weight and BMI experienced reductions of 33.4kg and 44.3kg, and 13.1kg/m(2) and 17.2kg/m(2), respectively. The positive impact on weight loss and the reduction in BMI, WC, and in the frequency of CVRFs are already extremely significant after six months and remain so one year after bariatric surgery. Copyright © 2013 Elsevier Editora Ltda. All rights reserved.

  10. A 12-month exercise intervention decreased stress symptoms and increased mental resources among working adults – Results perceived after a 12-month follow-up

    Directory of Open Access Journals (Sweden)

    Oili Kettunen

    2015-02-01

    Full Text Available Introduction This study evaluated the effect of a 12-month physical exercise intervention accompanied by a 12-month followup evaluating stress symptoms (SS, mental resources (MR and cardiorespiratory fitness (CRF in healthy, working adults. We hypothesized that the stress symptoms would decrease and mental resources would increase during the intervention and that these results are associated with changes in CRF. Material and methods The study group included healthy adults (N = 371. Three hundred thirty eight participants (212 women, 126 men were allocated in the exercise group and 33 in the control group (17 women and 16 men. For the analysis, the exercise group was divided into subgroups according to the baseline SS and MR. Stress symptoms and MR were measured using the Occupational Stress Questionnaire. Results During the 12-month exercise intervention, SS decreased by 16% (p < 0.0001, MR increased by 8% (p < 0.0001 and CRF increased by 7% (p < 0.0001 in the exercise group, while no changes occurred in the control group (ANCOVA, p < 0.01. In the exercise group, the results (SS, MR, and CRF remained improved during the follow-up. There was a positive correlation between the change in SS and the change in CRF (r = 0.19, p < 0.01. In the subgroup having the highest SS at baseline, SS during the intervention decreased most (26% (ANCOVA, p < 0.0001. Conclusions One year physical exercise intervention improved mental well-being among working adults and this was associated with an improvement in cardiorespiratory fitness. The positive changes remained after the 12-month follow-up.

  11. A Multi-Center Prospective Study to Validate an Algorithm Using Urine and Plasma Biomarkers for Predicting Gleason ≥3+4 Prostate Cancer on Biopsy

    DEFF Research Database (Denmark)

    Albitar, Maher; Ma, Wanlong; Lund, Lars

    2017-01-01

    a prospective multicenter study recruiting patients from community-based practices. Patients and Methods: Urine and plasma samples from 2528 men were tested prospectively. Results were correlated with biopsy findings, if a biopsy was performed as deemed necessary by the practicing urologist. Of the 2528......Background: Unnecessary biopsies and overdiagnosis of prostate cancer (PCa) remain a serious healthcare problem. We have previously shown that urine- and plasma-based prostate-specific biomarkers when combined can predict high grade prostate cancer (PCa). To further validate this test, we performed...... of high grade prostate cancer with negative predictive value (NPV) of 90% to 97% for Gleason ≥3+4 and between 98% to 99% for Gleason ≥4+3....

  12. Prediction of cesarean delivery in the term nulliparous woman: results from the prospective, multicenter Genesis study.

    Science.gov (United States)

    Burke, Naomi; Burke, Gerard; Breathnach, Fionnuala; McAuliffe, Fionnuala; Morrison, John J; Turner, Michael; Dornan, Samina; Higgins, John R; Cotter, Amanda; Geary, Michael; McParland, Peter; Daly, Sean; Cody, Fiona; Dicker, Pat; Tully, Elizabeth; Malone, Fergal D

    2017-06-01

    In contemporary practice many nulliparous women require intervention during childbirth such as operative vaginal delivery or cesarean delivery (CD). Despite the knowledge that the increasing rate of CD is associated with increasing maternal age, obesity and larger infant birthweight, we lack a reliable method to predict the requirement for such potentially hazardous obstetric procedures during labor and delivery. This issue is important, as there are greater rates of morbidity and mortality associated with unplanned CD performed in labor compared with scheduled CDs. A prediction algorithm to identify women at risk of an unplanned CD could help reduced labor associated morbidity. In this primary analysis of the Genesis study, our objective was to prospectively assess the use of prenatally determined, maternal and fetal, anthropomorphic, clinical, and ultrasound features to develop a predictive tool for unplanned CD in the term nulliparous woman, before the onset of labor. The Genesis study recruited 2336 nulliparous women with a vertex presentation between 39+0 and 40+6 weeks' gestation in a prospective multicenter national study to examine predictors of CD. At recruitment, a detailed clinical evaluation and ultrasound assessment were performed. To reduce bias from knowledge of these data potentially influencing mode of delivery, women, midwives, and obstetricians were blinded to the ultrasound data. All hypothetical prenatal risk factors for unplanned CD were assessed as a composite. Multiple logistic regression analysis and mathematical modeling was used to develop a risk evaluation tool for CD in nulliparous women. Continuous predictors were standardized using z scores. From a total enrolled cohort of 2336 nulliparous participants, 491 (21%) had an unplanned CD. Five parameters were determined to be the best combined predictors of CD. These were advancing maternal age (odds ratio [OR], 1.21; 95% confidence interval [CI], 1.09 to 1.34), shorter maternal height (OR

  13. The Influence of Back Pain and Urinary Incontinence on Daily Tasks of Mothers at 12 Months Postpartum

    Science.gov (United States)

    McDonald, Sheila W.; Tough, Suzanne C.

    2015-01-01

    Objective The present study examined back pain (BP) and/or urinary incontinence (UI) impact on the ability to perform daily tasks at 12 months after childbirth in healthy reproductive women who sought maternity care in community based family practice clinics. Methods This study is a secondary analysis from the All Our Babies Study, a prospective, community-based pregnancy cohort in Calgary, Alberta. Maternal self-reported information on demographics, lifestyle, experiences with pregnancy and childbirth, occurrence of BP, UI and consequent impairment of daily tasks were collected by questionnaires administered before 25 weeks, at 34-36 weeks gestation and at 4 and 12 months postpartum. The occurrence and severity of BP and UI at one year after childbirth was assessed using descriptive and bivariate analyses. Logistic regression models examined the association between demographic and obstetrical variables and the severity of functional impairment due to UI and BP. Results From 1574 women with singleton pregnancies included in the study, 1212 (77%) experienced BP, 773 (49%) UI, and 620 (40%) both BP and UI. From the 821 women reporting impairment of daily tasks due to BP, 199 (24 %) were moderately and 90 (11%) severely affected with the remainder, 532 (64%) being mildly affected. From 267 women with functional impairment due to UI, 52 (19%) reported moderately to severe impairment in their ability to perform daily tasks. Obesity and parity were risk factors for impairment of daily functioning due to BP, whereas obesity and vaginal delivery increased the risk of moderate to severe impairment due to UI. Conclusions BP and UI are common occurrences 1 year after childbirth. Maternal performance of daily tasks and women’s health and quality of life are more often impaired due to BP than UI. Our study brings new evidence of the risk factors that predict severity and impact of these conditions on women functioning at 12 months postpartum. PMID:26083252

  14. The Influence of Back Pain and Urinary Incontinence on Daily Tasks of Mothers at 12 Months Postpartum.

    Directory of Open Access Journals (Sweden)

    Cynthia A Mannion

    Full Text Available The present study examined back pain (BP and/or urinary incontinence (UI impact on the ability to perform daily tasks at 12 months after childbirth in healthy reproductive women who sought maternity care in community based family practice clinics.This study is a secondary analysis from the All Our Babies Study, a prospective, community-based pregnancy cohort in Calgary, Alberta. Maternal self-reported information on demographics, lifestyle, experiences with pregnancy and childbirth, occurrence of BP, UI and consequent impairment of daily tasks were collected by questionnaires administered before 25 weeks, at 34-36 weeks gestation and at 4 and 12 months postpartum. The occurrence and severity of BP and UI at one year after childbirth was assessed using descriptive and bivariate analyses. Logistic regression models examined the association between demographic and obstetrical variables and the severity of functional impairment due to UI and BP.From 1574 women with singleton pregnancies included in the study, 1212 (77% experienced BP, 773 (49% UI, and 620 (40% both BP and UI. From the 821 women reporting impairment of daily tasks due to BP, 199 (24 % were moderately and 90 (11% severely affected with the remainder, 532 (64% being mildly affected. From 267 women with functional impairment due to UI, 52 (19% reported moderately to severe impairment in their ability to perform daily tasks. Obesity and parity were risk factors for impairment of daily functioning due to BP, whereas obesity and vaginal delivery increased the risk of moderate to severe impairment due to UI.BP and UI are common occurrences 1 year after childbirth. Maternal performance of daily tasks and women's health and quality of life are more often impaired due to BP than UI. Our study brings new evidence of the risk factors that predict severity and impact of these conditions on women functioning at 12 months postpartum.

  15. Does intraoperative neuromonitoring of recurrent nerves have an impact on the postoperative palsy rate? Results of a prospective multicenter study.

    Science.gov (United States)

    Mirallié, Éric; Caillard, Cécile; Pattou, François; Brunaud, Laurent; Hamy, Antoine; Dahan, Marcel; Prades, Michel; Mathonnet, Muriel; Landecy, Gérard; Dernis, Henri-Pierre; Lifante, Jean-Christophe; Sebag, Frederic; Jegoux, Franck; Babin, Emmanuel; Bizon, Alain; Espitalier, Florent; Durand-Zaleski, Isabelle; Volteau, Christelle; Blanchard, Claire

    2018-01-01

    The impact of intraoperative neuromonitoring on recurrent laryngeal nerve palsy remains debated. Our aim was to evaluate the potential protective effect of intraoperative neuromonitoring on recurrent laryngeal nerve during total thyroidectomy. This was a prospective, multicenter French national study. The use of intraoperative neuromonitoring was left at the surgeons' choice. Postoperative laryngoscopy was performed systematically at day 1 to 2 after operation and at 6 months in case of postoperative recurrent laryngeal nerve palsy. Univariate and multivariate analyses and propensity score (sensitivity analysis) were performed to compare recurrent laryngeal nerve palsy rates between patients operated with or without intraoperative neuromonitoring. Among 1,328 patients included (females 79.9%, median age 51.2 years, median body mass index 25.6 kg/m 2 ), 807 (60.8%) underwent intraoperative neuromonitoring. Postoperative abnormal vocal cord mobility was diagnosed in 131 patients (9.92%), including 69 (8.6%) and 62 (12.1%) in the intraoperative neuromonitoring and nonintraoperative neuromonitoring groups, respectively. Intraoperative neuromonitoring was associated with a lesser rate of recurrent laryngeal nerve palsy in univariate analysis (odds ratio = 0.68, 95% confidence interval, 0.47; 0.98, P = .04) but not in multivariate analysis (oddsratio = 0.74, 95% confidence interval, 0.47; 1.17, P = .19), or when using a propensity score (odds ratio = 0.76, 95% confidence interval, 0.53; 1.07, P = .11). There was no difference in the rates of definitive recurrent laryngeal nerve palsy (0.8% and 1.3% in intraoperative neuromonitoring and non-intraoperative neuromonitoring groups respectively, P = .39). The sensitivity, specificity, and positive and negative predictive values of intraoperative neuromonitoring for detecting abnormal postoperative vocal cord mobility were 29%, 98%, 61%, and 94%, respectively. The use of intraoperative

  16. A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients.

    Science.gov (United States)

    Saito, Shuji; Yoshida, Shuntaro; Isayama, Hiroyuki; Matsuzawa, Takeaki; Kuwai, Toshio; Maetani, Iruru; Shimada, Mamoru; Yamada, Tomonori; Tomita, Masafumi; Koizumi, Koichi; Hirata, Nobuto; Kanazawa, Hideki; Enomoto, Toshiyuki; Sekido, Hitoshi; Saida, Yoshihisa

    2016-09-01

    Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study. Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery. A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively. This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute

  17. Stable cognitive deficits in schizophrenia patients with comorbid obsessive-compulsive symptoms: a 12-month longitudinal study.

    Science.gov (United States)

    Schirmbeck, Frederike; Rausch, Franziska; Englisch, Susanne; Eifler, Sarah; Esslinger, Christine; Meyer-Lindenberg, Andreas; Zink, Mathias

    2013-11-01

    Amongst schizophrenia patients, a large subgroup of up to 25% also suffers from comorbid obsessive-compulsive symptoms (OCSs). The association between comorbid OCSs in these patients and neuropsychological impairment remains unclear and somewhat contradictory. Longitudinal approaches investigating the stability of OCS-associated cognitive deficits are missing. Thirty-seven patients with schizophrenia and comorbid OCSs and 43 schizophrenia patients without OCS were assessed with a comprehensive cognitive test battery and compared at baseline and, again, 12 months later. Schizophrenia patients with comorbid OCSs showed significant pronounced deficits, with increasing effect sizes over the 12-month assessment period in specific cognitive areas such as visuospatial perception and visual memory (WAIS-R block design, Rey-Osterrieth Complex Figure Test), executive functioning (perseveration in the Wisconsin Card Sorting test), and cognitive flexibility (Trail Making test B). These cognitive domains are correlated with OCS severity and are known to be candidate cognitive domains in obsessive-compulsive disorder (OCD). OCSs in schizophrenia is associated with specific and longitudinally stable cognitive deficits, strongly arguing for at least partially overlapping neurobiological mechanisms with OCD. Prospective studies involving patients with at-risk mental states for psychosis are necessary to decipher the interaction of cognitive impairment and the clinical manifestations of schizophrenia and OCSs. This might facilitate the definition of patients at high risk for OCSs, an early detection of subclinical levels, therapeutic interventions, and clinical monitoring.

  18. Improved plasma amino acids pattern following 12 months of supplemented low-protein diet in peritoneal dialysis patients.

    Science.gov (United States)

    Jiang, Na; Qian, Jiaqi; Lin, Aiwu; Fang, Wei; Cao, Liou; Wang, Qin; Ni, Zhaohui; Lindholm, Bengt; Axelsson, Jonas; Yao, Qiang

    2010-07-01

    Decreased plasma essential amino acid (EAA) levels, increased nonessential amino acid (NEAA) levels, and low EAA to NEAA ratio (E/NEAA) are common in peritoneal dialysis (PD) patients and may impact uremic complications. In the present study, we investigate the impact of keto acids-supplemented low-protein (sLP) diet on plasma amino acids (AAs) patterns in stable PD patients. This is a supplemental analysis of a previously published prospective and randomized trial. Thirty-nine PD patients selected from the original population were divided to receive either low (LP: 0.6-0.8 g/kg ideal body weight [IBW]/d, n = 13), keto acids-supplemented low- (sLP: 0.6-0.8 g/kg IBW/d + 0.12 g/kg IBW/d of keto acids, n = 12), or high- (HP: 1.0-1.2 g/kg IBW/d, n = 14) protein diets and followed for 1 year. Plasma AA patterns were assessed at baseline and 12 months using high-performance liquid chromatography. Whereas there were no significant differences between the three groups at baseline, following 12 months, the E/NEAA had increased significantly in group sLP (0.58 +/- 0.16 to 0.83 +/- 0.20, p diet supplemented with keto acids significantly improved the pattern of plasma AA in prevalent PD patients.

  19. Unfulfilled rehabilitation needs and dissatisfaction with care 12 months after a stroke

    DEFF Research Database (Denmark)

    Tistad, Malin; Tham, Kerstin; von Koch, Lena

    2012-01-01

    a questionnaire. Stroke severity, domains of the Stroke Impact Scale (SIS), the Sense of Coherence scale (SOC) and socio demographic factors were used as independent variables in four logistic regression analyses. RESULTS: Unfulfilled needs for rehabilitation at 12 months were predicted by strength (SIS) (odds......BACKGROUND: People who have suffered a stroke commonly report unfulfilled need for rehabilitation. Using a model of patient satisfaction, we examined characteristics in individuals that at 3 months after stroke predicted, or at 12 months were associated with unmet need for rehabilitation...... or dissatisfaction with health care services at 12 months after stroke. METHODS: The participants (n = 175) received care at the stroke units at the Karolinska University Hospital, Sweden. The dependent variables "unfulfilled needs for rehabilitation" and "dissatisfaction with care" were collected using...

  20. Infant pain-related negative affect at 12 months of age: early infant and caregiver predictors.

    Science.gov (United States)

    Din Osmun, Laila; Pillai Riddell, Rebecca; Flora, David B

    2014-01-01

    To examine the predictive relationships of early infant and caregiver variables on expressed pain-related negative affect duration at the 12-month immunization. Infants and their caregivers (N = 255) were followed during immunization appointments over the first year of life. Latent growth curve modeling in a structural equation modeling context was used. Higher levels of initial infant pain reactivity at 2 months and caregiver emotional availability averaged across 2, 4, and 6 months of age were related to larger decreases in the duration of infant negative affect over the first 6 months of life. Longer duration of infant negative affect at 2 months and poorer regulation of infant negative affect over the first 6 months of life predicted longer durations of infant negative affect by 12 months. Infant negative affect at 12 months was a function of both infant factors and the quality of caregiver interactive behaviors (emotional availability) in early infancy.

  1. Time-course of exercise and its association with 12-month bone changes

    Directory of Open Access Journals (Sweden)

    Vainionpää Aki

    2009-11-01

    Full Text Available Abstract Background Exercise has been shown to have positive effects on bone density and strength. However, knowledge of the time-course of exercise and bone changes is scarce due to lack of methods to quantify and qualify daily physical activity in long-term. The aim was to evaluate the association between exercise intensity at 3, 6 and 12 month intervals and 12-month changes in upper femur areal bone mineral density (aBMD and mid-femur geometry in healthy premenopausal women. Methods Physical activity was continuously assessed with a waist-worn accelerometer in 35 healthy women (35-40 years participating in progressive high-impact training. To describe exercise intensity, individual average daily numbers of impacts were calculated at five acceleration levels (range 0.3-9.2 g during time intervals of 0-3, 0-6, and 0-12 months. Proximal femur aBMD was measured with dual x-ray absorptiometry and mid-femur geometry was evaluated with quantitative computed tomography at the baseline and after 12 months. Physical activity data were correlated with yearly changes in bone density and geometry, and adjusted for confounding factors and impacts at later months of the trial using multivariate analysis. Results Femoral neck aBMD changes were significantly correlated with 6 and 12 months' impact activity at high intensity levels (> 3.9 g, r being up to 0.42. Trochanteric aBMD changes were associated even with first three months of exercise exceeding 1.1 g (r = 0.39-0.59, p r = 0.38-0.52, p Conclusion The number of high acceleration impacts during 6 months of training was positively associated with 12-month bone changes at the femoral neck, trochanter and mid-femur. These results can be utilized when designing feasible training programs to prevent bone loss in premenopausal women. Trial registration Clinical trials.gov NCT00697957

  2. HIIT in the Real World: Outcomes from a 12-Month Intervention in Overweight Adults.

    Science.gov (United States)

    Roy, Melyssa; Williams, Sheila M; Brown, Rachel C; Meredith-Jones, Kim A; Osborne, Hamish; Jospe, Michelle; Taylor, Rachael W

    2018-04-21

    Although high-intensity interval training (HIIT) and moderate-intensity continuous exercise have comparable health outcomes in the laboratory setting, effectiveness studies in real-world environments are lacking. The aim of this study was to determine the effectiveness of an unsupervised HIIT programme in overweight/obese adults over 12 months. 250 overweight/obese adults could choose HIIT or current exercise guidelines of 30 minutes/day moderate-intensity exercise. HIIT participants received a single training session and were advised to independently perform HIIT 3x/week utilizing a variety of protocols. Mixed models, with a random effect for participant, compared differences in weight, body composition, blood pressure, aerobic fitness, physical activity and blood indices at 12 months, adjusting for relevant baseline variables. Forty-two percent (n=104) of eligible participants chose HIIT in preference to current guidelines. At 12 months, there were no differences between exercise groups in weight (adjusted difference HIIT vs conventional; 95% CI: -0.44kg; -2.5, 1.6) or visceral fat (-103cm; -256, 49), although HIIT participants reported greater enjoyment of physical activity (p=0.01). Evidence of adherence to ≥2 sessions/week of unsupervised HIIT (from heart rate monitoring) declined from 60.8% at baseline to 19.6% by 12 months. Participants remaining adherent to HIIT over 12 months (23%) were more likely to be male (67% vs 36%, p=0.03), with greater reductions in weight (-2.7kg; -5.2 -0.2) and visceral fat (-292cm; -483, -101) than non-adherent participants. HIIT was well-accepted by overweight adults and opting for HIIT as an alternative to standard exercise recommendations led to no difference in health outcomes after 12 months. While regular participation in unsupervised HIIT declined rapidly, those apparently adherent to regular HIIT demonstrated beneficial weight loss and visceral fat reduction. Australian New Zealand Clinical Trials Registry (ACTRN

  3. Long-distance longitudinal prostate MRI quality assurance: from startup to 12 months.

    Science.gov (United States)

    Curci, Nicole E; Gartland, Patrick; Shankar, Prasad R; Montgomery, Jeffrey S; Miller, David C; George, Arvin K; Davenport, Matthew S

    2018-02-22

    To evaluate a 12-month long-distance prostate MRI quality assurance (QA) program. The need for IRB approval was waived for this prospective longitudinal QA effort. One academic institution experienced with prostate MRI [~ 1000 examinations/year (Site 2)] partnered with a private institution 240 miles away that was starting a new prostate MRI program (Site 1). Site 1 performed all examinations (N = 249). Four radiologists at Site 1 created finalized reports, then sent images and reports to Site 2 for review on a rolling basis. One radiologist at Site 2 reviewed findings and exam quality and discussed results by phone (~ 2-10 minutes/MRI). In months 1-6 all examinations were reviewed. In months 7-12 only PI-RADS ≤ 2 and 'difficult' cases were reviewed. Repeatability was assessed with intra-class correlation (ICC). 'Clinically significant cancer' was Gleason ≥ 7. Image quality significantly (p < 0.001) improved after the first three months. Inter-rater agreement also improved in months 3-4 [ICC: 0.849 (95% CI 0.744-0.913)] and 5-6 [ICC: 0.768 (95% CI 0.619-0.864)] compared to months 1-2 [ICC: 0.621 (95% CI 0.436-0.756)]. PI-RADS ≤ 2 examinations were reclassified PI-RADS ≥ 3 in 19% (30/162); of these, 23 had post-MRI histology and 57% (13/23) had clinically significant cancer (5.2% of 249). False-negative examinations [N = 18 (PI-RADS ≤ 2 and Gleason ≥ 7)] were more common at Site 1 during months 1-6 [9% (14/160) vs. 4% (4/89)]. Positive predictive values for PI-RADS ≥ 3 were similar. Remote quality assurance of prostate MRI is feasible and useful, enabling new programs to gain durable skills with minimal risk to patients.

  4. Objectively measured physical activity and 12-month trajectories of neck-shoulder pain in workers

    DEFF Research Database (Denmark)

    Hallman, David M.; Birk Jørgensen, Marie; Holtermann, Andreas

    2017-01-01

    Aims: This study aimed to investigate the association between objectively measured physical activity at work and leisure and the intensity (mean level and time course) of neck-shoulder pain (NSP) over 12 months among male and female blue collar workers. Methods: Data were obtained from 625 blue...... of NSP (numerical rating scale 0-10) were collected using text messages every fourth week over 12 months. Linear mixed models were used to investigate the associations between occupational physical activity (OPA) and leisure time physical activity (LTPA) and the trajectories of the intensity of NSP...

  5. Rationale and design of the worldwide prospective multicenter registry on radiation dose estimates of cardiac CT angiography in daily practice in 2017 (PROTECTION VI)

    DEFF Research Database (Denmark)

    Stocker, Thomas J; Deseive, Simon; Chen, Marcus

    2018-01-01

    -randomized and randomized studies have been performed to reduce the associated radiation exposure. Currently, it is unclear if the advances in technology and knowledge about radiation reduction translated into reduced levels of cardiac CTA radiation dose in daily clinical practice as well as a wide utilization of dose......-saving strategies. METHODS: The PROTECTION VI study is a multicenter, prospective, worldwide registry designed to evaluate radiation dose exposure, utilization of dose-saving strategies and diagnostic image quality during cardiac CTA in current daily practice. Assessment of image quality will be addressed...... median radiation dose levels, image quality, frequency of use and efficacy of algorithms for dose reduction, and patient and study-related predictors associated with radiation dose. CONCLUSIONS: The PROTECTION VI study is designed to provide a reliable estimate of current radiation dose for cardiac CTA...

  6. Prospective multicenter observational study of 260 infants born to 259 opiate-dependent mothers on methadone or high-dose buprenophine substitution.

    Science.gov (United States)

    Lejeune, Claude; Simmat-Durand, Laurence; Gourarier, Laurent; Aubisson, Sandrine

    2006-05-20

    Specialized prenatal care and substitution programs improve the perinatal prognoses of pregnant drug-abusers and their infants. Although methadone is well documented, little is known about high-dose buprenorphine (HDB). This prospective, multicenter (n = 35) observational study included 259 women on maintenance during pregnancy: 39% on methadone and 61% on HDB. Major findings were: 46% of them received good prenatal care; 62% had peridural analgesia; 12.3% delivered prematurely (hydrochloride. No baby died. Newborns were discharged with their mothers (96%) or placed in foster care (4%). Comparing methadone with HDB, respectively, mean age at the maximum Lipsitz score was 81 h versus 66 h (P = 0.066). The perinatal medical and social prognoses for these 259 drug addicts and their infants appeared to be improved by specialized prenatal care and was similar for methadone or BHD substitution during pregnancy.

  7. Nutrition-related risk indexes and long-term mortality in noncritically ill inpatients who receive total parenteral nutrition (prospective multicenter study).

    Science.gov (United States)

    Tapia, María José; Ocón, Julia; Cabrejas-Gómez, Carmen; Ballesteros-Pomar, María D; Vidal-Casariego, Alfonso; Arraiza-Irigoyen, Carmen; Olivares, Josefina; Conde-García, Ma Carmen; García-Manzanares, Álvaro; Botella-Romero, Francisco; Quílez-Toboso, Rosa P; Cabrerizo, Lucio; Rubio, Miguel A; Chicharro, Luisa; Burgos, Rosa; Pujante, Pedro; Ferrer, Mercedes; Zugasti, Ana; Petrina, Estrella; Manjón, Laura; Diéguez, Marta; Carrera, Ma José; Vila-Bundo, Anna; Urgelés, Juan Ramón; Aragón-Valera, Carmen; Sánchez-Vilar, Olga; Bretón, Irene; García-Peris, Pilar; Muñoz-Garach, Araceli; Márquez, Efren; del Olmo, Dolores; Pereira, José Luis; Tous, María C; Olveira, Gabriel

    2015-10-01

    Malnutrition in hospitalized patients is associated with an increased risk of death, in both the short and the long term. The purpose of this study was to determine which nutrition-related risk index predicts long-term mortality better (three years) in patients who receive total parenteral nutrition (TPN). This prospective, multicenter study involved noncritically ill patients who were prescribed TPN during hospitalization. Data were collected on Subjective Global Assessment (SGA), Nutritional Risk Index (NRI), Geriatric Nutritional Risk Index (GNRI), body mass index, albumin and prealbumin, as well as long-term mortality. Over the 1- and 3-year follow-up periods, 174 and 244 study subjects (28.8% and 40.3%) respectively, died. Based on the Cox proportional hazards survival model, the nutrition-related risk indexes most strongly associated with mortality were SGA and albumin (Nutrition and Metabolism. All rights reserved.

  8. Prospective multicenter surveillance and risk factor analysis of deep surgical site infection after posterior thoracic and/or lumbar spinal surgery in adults.

    Science.gov (United States)

    Ogihara, Satoshi; Yamazaki, Takashi; Maruyama, Toru; Oka, Hiroyuki; Miyoshi, Kota; Azuma, Seiichi; Yamada, Takashi; Murakami, Motoaki; Kawamura, Naohiro; Hara, Nobuhiro; Terayama, Sei; Morii, Jiro; Kato, So; Tanaka, Sakae

    2015-01-01

    Surgical site infection is a serious and significant complication after spinal surgery and is associated with high morbidity rates, high healthcare costs and poor patient outcomes. Accurate identification of risk factors is essential for developing strategies to prevent devastating infections. The purpose of this study was to identify independent risk factors for surgical site infection among posterior thoracic and/or lumbar spinal surgery in adult patients using a prospective multicenter surveillance research method. From July 2010 to June 2012, we performed a prospective surveillance study in adult patients who had developed surgical site infection after undergoing thoracic and/or lumbar posterior spinal surgery at 11 participating hospitals. Detailed preoperative and operative patient characteristics were prospectively recorded using a standardized data collection format. Surgical site infection was based on the definition established by the Centers for Disease Control and Prevention. A total of 2,736 consecutive adult patients were enrolled, of which 24 (0.9%) developed postoperative deep surgical site infection. Multivariate regression analysis indicated four independent risk factors. Preoperative steroid therapy (P = 0.001), spinal trauma (P = 0.048) and gender (male) (P = 0.02) were statistically significant independent patient-related risk factors, whereas an operating time ≥3 h (P operating time ≥3 h were independent risk factors for deep surgical site infection after thoracic and/or lumbar spinal surgery in adult patients. Identification of these risk factors can be used to develop protocols aimed at decreasing the risk of surgical site infection.

  9. The Spectrum of Histopathological Changes in the Renal Allograft - a 12 Months Protocol Biopsy Study

    Directory of Open Access Journals (Sweden)

    Galina Severova-Andreevska

    2018-03-01

    CONCLUSION: Our 12-month protocol biopsy study revealed the presence of different forms of mixed subclinical rejection. Use of recent BANFF classification and scoring system enables more precise diagnosis and subsequently different approach to the further treatment of the KTR. More correlative long-term studies including Anti HLA antibodies and Endothelial Cell Activation- Associated Transcripts (ENDAT are needed.

  10. The outcome at 12 months of very-Iow-birth-weight infants ventilated ...

    African Journals Online (AJOL)

    Main outcome measures. Attrition rates for rural and urban babies, BPD, ROP, IVH and abnormal motor development. Study population and setting. All ventilated VLBW infants discharged from the neonatal intensive care unit at Tygerberg Hospital over a 1-year period were followed up at 3-monthly intervals for 12 months.

  11. Sequential Analysis of Mastery Behavior in 6- and 12-Month-Old Infants.

    Science.gov (United States)

    MacTurk, Robert H.; And Others

    1987-01-01

    Sequences of mastery behavior were analyzed in a sample of 67 infants 6 to 12 months old. Authors computed (a) frequencies of six categories of mastery behavior, transitional probabilities, and z scores for each behavior change, and (b) transitions from a mastery behavior to positive affect. Changes in frequencies and similarity in organization…

  12. A 12-month follow-up study of treating overweight schizophrenic patients with aripiprazole

    NARCIS (Netherlands)

    Schorr, S. G.; Slooff, C. J.; Postema, R.; Van Oven, W.; Schilthuis, M.; Bruggeman, R.; Taxis, K.

    Objective: To investigate the feasibility of switching overweight schizophrenic patients to aripiprazole and to assess the impact of 12 months of aripiprazole treatment on weight in routine practice. Method: This was a non-controlled cohort study in overweight schizophrenic patients. Data were

  13. Understanding the Abstract Role of Speech in Communication at 12 Months

    Science.gov (United States)

    Martin, Alia; Onishi, Kristine H.; Vouloumanos, Athena

    2012-01-01

    Adult humans recognize that even unfamiliar speech can communicate information between third parties, demonstrating an ability to separate communicative function from linguistic content. We examined whether 12-month-old infants understand that speech can communicate before they understand the meanings of specific words. Specifically, we test the…

  14. 12-Month Follow-Up of Fluoxetine and Cognitive Behavioral Therapy for Binge Eating Disorder

    Science.gov (United States)

    Grilo, Carlos M.; Crosby, Ross D.; Wilson, G. Terence; Masheb, Robin M.

    2012-01-01

    Objective: The longer term efficacy of medication treatments for binge-eating disorder (BED) remains unknown. This study examined the longer term effects of fluoxetine and cognitive behavioral therapy (CBT) either with fluoxetine (CBT + fluoxetine) or with placebo (CBT + placebo) for BED through 12-month follow-up after completing treatments.…

  15. Transition from 12 months to 18 months cycles at Krsko in a core physics perspective

    International Nuclear Information System (INIS)

    Jensen-Tornehed, J.

    2004-01-01

    Krsko has historically been operating in 12 months cycles with an annual outage for refuelling and maintenance work. Krsko is now in a transition from 12 months to 18 months cycles. Cycle 19, June 2002 - May 2003, was the last 12 month cycle. Cycle 20, June 2003 - September 2004 is a 15 month transition cycle and cycle 21, September 2004 - April 2006 will be the first 18 month cycle. This paper will describe the effects of the transition in a core physics perspective. There are big differences in how to design an 18 month cycle in comparison with a 12 month cycle. The required number of feed assemblies increases, as well as the content of burnable absorbers in the fuel. The strategy of the loading pattern has to be changed with the increased number of fresh fuel assemblies. The most limiting margins can be different for different cycle lengths which also affect the fresh assembly design and loading pattern during the transition. During the core design for cycle 21 the Moderator Temperature Coefficient was the main issue, which caused the need for extra amount of burnable absorbers. (author)

  16. Fish oil affects immune function in 9 to 12 month old infants

    DEFF Research Database (Denmark)

    Damsgaard, Camilla Trab; Lauritzen, Lotte; Kjær, Tanja

    2006-01-01

    /day) or no fish oil and cow’s milk or infant formula from 9 to 12 month of age in 64 healthy Danish infants. Before and after the intervention we measured the fatty acid composition of erythrocyte (RBC) membranes, plasma IgE levels, C-reactive protein and soluble IL-2 receptors (sIL-2R) as well as cytokine...

  17. Associations of obesity with tracheal intubation success on first attempt and adverse events in the emergency department: An analysis of the multicenter prospective observational study in Japan.

    Science.gov (United States)

    Yakushiji, Hiromasa; Goto, Tadahiro; Shirasaka, Wataru; Hagiwara, Yusuke; Watase, Hiroko; Okamoto, Hiroshi; Hasegawa, Kohei

    2018-01-01

    Obesity is deemed to increase the risk of difficult tracheal intubation. However, there is a dearth of research that examines the relationship of obesity with intubation success and adverse events in the emergency department (ED). We analyzed the data from a prospective, observational, multicenter study-the Japanese Emergency Airway Network (JEAN) 2 study from 2012 through 2016. We included all adults (aged ≥18 years) who underwent tracheal intubation in the ED. Patients were categorized into three groups according to their body mass index (BMI): lean (<25.0 kg/m²), overweight (25.0-29.9 kg/m²), and obesity (≥30.0 kg/m²). Outcomes of interest were intubation success on the first attempt and intubation-related adverse events. Of 6,889 patients who are eligible for the analysis, 5,370 patients (77%) were lean, 1,177 (17%) were overweight, and 342 (4%) were obese. Compared to the lean patients, the intubation success rates were significantly lower in the overweight and obese patients (70.9% in lean, 66.4% in overweight, and 59.3% in obese patients; P<0.001). In the multivariable analysis, compared to the lean patients, overweight (adjusted odds ratio [OR], 0.85; 95%CI, 0.74-0.98) and obese (adjusted OR, 0.62; 95%CI, 0.49-0.79) patients had a significantly lower success rate on the first attempt. Additionally, obesity was significantly associated with a higher risk of adverse events (adjusted OR, 1.62; 95%CI, 1.23-2.13). Based on the data from a multicenter prospectively study, obesity was associated with a lower success rate on the first intubation attempt and a higher risk of adverse event in the ED.

  18. How Many Samples and How Many Culture Media To Diagnose a Prosthetic Joint Infection: a Clinical and Microbiological Prospective Multicenter Study.

    Science.gov (United States)

    Bémer, Pascale; Léger, Julie; Tandé, Didier; Plouzeau, Chloé; Valentin, Anne Sophie; Jolivet-Gougeon, Anne; Lemarié, Carole; Kempf, Marie; Héry-Arnaud, Geneviève; Bret, Laurent; Juvin, Marie Emmanuelle; Giraudeau, Bruno; Corvec, Stéphane; Burucoa, Christophe

    2016-02-01

    Although numerous perioperative samples and culture media are required to diagnose prosthetic joint infection (PJI), their exact number and types have not yet been definitely determined with a high level of proof. We conducted a prospective multicenter study to determine the minimal number of samples and culture media required for accurate diagnosis of PJI. Over a 2-year period, consecutive patients with clinical signs suggesting PJI were included, with five perioperative samples per patient. The bacteriological and PJI diagnosis criteria were assessed using a random selection of two, three, or four samples and compared with those obtained using the recommended five samples (references guidelines). The results obtained with two or three culture media were then compared with those obtained with five culture media for both criteria. The times-to-positivity of the different culture media were calculated. PJI was confirmed in 215/264 suspected cases, with a bacteriological criterion in 192 (89%). The PJI was monomicrobial (85%) or polymicrobial (15%). Percentages of agreement of 98.1% and 99.7%, respectively, for the bacteriological criterion and confirmed PJI diagnosis were obtained when four perioperative samples were considered. The highest percentages of agreement were obtained with the association of three culture media, a blood culture bottle, a chocolate agar plate, and Schaedler broth, incubated for 5, 7, and 14 days, respectively. This new procedure leads to significant cost saving. Our prospective multicenter study showed that four samples seeded on three culture media are sufficient for diagnosing PJI. Copyright © 2016, American Society for Microbiology. All Rights Reserved.

  19. Physical inactivity at leisure and work: a 12-month study of cardiac patients.

    Science.gov (United States)

    Rogerson, Michelle C; Murphy, Barbara M; Le Grande, Michael R; Worcester, Marian U C

    2013-01-01

    Physical inactivity has been identified as a distinct health risk. However, little is known about how this can vary at leisure and work in cardiac patients. The aim of this study was to examine the prevalence and predictors of inactivity during leisure and work in the 12 months following a cardiac event in Australian cardiac patients. A total of 346 patients consecutively admitted to hospital with acute coronary syndrome or to undergo coronary artery bypass graft surgery were interviewed in hospital, and 4 and 12 months later. Leisure and occupational physical activity was measured using the Stanford Brief Activity Survey. Sociodemographic, psychosocial, and clinical data were also collected. The prevalence of leisure-time physical inactivity declined over time, with 52% inactive preevent and 29% inactive at 12 months. Approximately 50% of participants were physically inactive in their work, regardless of whether this was measured before or after the cardiac event. Logistic regression revealed that the significant predictors of leisure-time physical inactivity at 12 months were non-home ownership (OR = 2.19; P = .007) and physical inactivity in leisure-time prior to the event (OR = 2.44; P = .001). The significant predictors of occupational physical inactivity at 12 months were white-collar occupation (OR = 3.10; P physical inactivity at work prior to the event (OR = 12.99; P physical inactivity, socioeconomic, and clinical factors predicted both leisure and work inactivity after an acute cardiac event. Effective interventions could be designed and implemented to target those most at risk of being physically inactive at work or leisure.

  20. β-Blocker Therapy Prior to Admission for Acute Coronary Syndrome in Patients Without Heart Failure or Left Ventricular Dysfunction Improves In-Hospital and 12-Month Outcome: Results From the GULF-RACE 2 (Gulf Registry of Acute Coronary Events-2).

    Science.gov (United States)

    Abi Khalil, Charbel; AlHabib, Khalid F; Singh, Rajvir; Asaad, Nidal; Alfaleh, Hussam; Alsheikh-Ali, Alawi A; Sulaiman, Kadhim; Alshamiri, Mostafa; Alshaer, Fayez; AlMahmeed, Wael; Al Suwaidi, Jassim

    2017-12-20

    The prognostic impact of β-blockers (BB) in acute coronary syndrome (ACS) patients without heart failure (HF) or left ventricular dysfunction is controversial, especially in the postreperfusion era. We sought to determine whether a BB therapy before admission for ACS has a favorable in-hospital outcome in patients without HF, and whether they also reduce 12-month mortality if still prescribed on discharge. The GULF-RACE 2 (Gulf Registry of Acute Coronary Events-2) is a prospective multicenter study of ACS in 6 Middle Eastern countries. We studied in-hospital cardiovascular events in patients hospitalized for ACS without HF in relation to BB on admission, and 1-year mortality in relation to BB on discharge. Among the 7903 participants, 7407 did not have HF, of whom 5937 (80.15%) patients were on BB. Patients on BB tended to be older and have more comorbidities. However, they had a lower risk of in-hospital mortality, mitral regurgitation, HF, cardiogenic shock, and ventricular tachycardia/ventricular fibrillation. Furthermore, 4208 patients were discharged alive and had an ejection fraction ≥40%. Among those, 84.1% had a BB prescription. At 12 months, they also had a reduced risk of mortality as compared with the non-BB group. Even after correcting for confounding factors in 2 different models, in-hospital and 12-month mortality risk was still lower in the BB group. In this cohort of ACS, BB therapy before admission for ACS is associated with decreased in-hospital mortality and major cardiovascular events, and 1-year mortality in patients without HF or left ventricular dysfunction if still prescribed on discharge. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  1. Socio-demographic and clinical profiles of paranoid and nonparanoid schizophrenia: a prospective, multicenter study in China.

    Science.gov (United States)

    Xiang, Yu-Tao; Wang, Chuan-Yue; Chiu, Helen F K; Weng, Yong-Zhen; Bo, Qi-Jing; Chan, Sandra S M; Lee, Edwin H M; Ungvari, Gabor S

    2011-07-01

    This study aimed to explore the socio-demographic and clinical characteristics of paranoid and nonparanoid subtypes of schizophrenia. In a multicenter, randomized, controlled, longitudinal study, 374 clinically stable schizophrenia patients were interviewed at entry with standardized assessment instruments and followed for 12-26 months. In the multivariate analysis, male sex, married marital status, urban abode, and more frequent relapse over the study period were independently associated with paranoid schizophrenia. The socio-demographic and clinical characteristics of Chinese patients with the paranoid subtype of schizophrenia are different from those of their Caucasian counterparts who are more likely to be women and have a better outcome. © 2010 Wiley Periodicals, Inc.

  2. Italian multicenter, prospective study to evaluate the negative predictive value of 16- and 64-slice MDCT imaging in patients scheduled for coronary angiography (NIMISCAD-non invasive multicenter Italian study for coronary artery disease)

    International Nuclear Information System (INIS)

    Marano, Riccardo; Cobelli, Francesco de; Maschio, Alessandro del; Becker, Christoph; Herzog, Christopher; Centonze, Maurizio; Morana, Giovanni; Gualdi, Gian Franco; Ligabue, Guido; Pontone, Gianluca; Catalano, Carlo; Chiappino, Dante; Midiri, Massimo; Simonetti, Giovanni; Marchisio, Filippo; Olivetti, Lucio; Fattori, Rossella; Bonomo, Lorenzo

    2009-01-01

    This was a prospective, multicenter study designed to evaluate the utility of MDCT in the diagnosis of coronary artery disease (CAD) in patients scheduled for elective coronary angiography (CA) using different MDCT systems from different manufacturers. Twenty national sites prospectively enrolled 367 patients between July 2004 and June 2006. Computed tomography (CT) was performed using a standardized/optimized scan protocol for each type of MDCT system (≥16 slices) and compared with quantitative CA performed within 2 weeks of MDCT. A total of 284 patients (81%) were studied by 16-slice MDCT systems, while 66 patients (19%) by 64-slice MDCT scanners. The primary analysis was on-site/off-site evaluation of the negative predictive value (NPV) on a per-patient basis. Secondary analyses included on-site evaluation on a per-artery and per-segment basis. On-site evaluation included 327 patients (CAD prevalence 58%). NPV, positive predictive value (PPV), sensitivity, specificity, and diagnostic accuracy (DA) were 0.91 (95% CI 0.85-0.95), 0.91 (95% CI 0.86-0.95), 0.94 (95% CI 0.89-0.97), 0.88 (95% CI 0.81-0.93), and 0.91 (95% CI 0.88-0.94), respectively. Off-site analysis included 295 patients (CAD prevalence 56%). NPV, PPV, sensitivity, specificity, and DA were 0.73 (95% CI 0.65-0.79), 0.93 (95% CI 0.87-0.97), 0.73 (95% CI 0.65-0.79), 0.93 (95% CI 0.87-0.97), and 0.82 (95% CI 0.77-0.86), respectively. The results of this study demonstrate the utility of MDCT in excluding significant CAD even when conducted by centers with varying degrees of expertise and using different MDCT machines. (orig.)

  3. Transvenous stimulation of the phrenic nerve for the treatment of central sleep apnoea: 12 months' experience with the remedē® System.

    Science.gov (United States)

    Jagielski, Dariusz; Ponikowski, Piotr; Augostini, Ralph; Kolodziej, Adam; Khayat, Rami; Abraham, William T

    2016-11-01

    Patients with central sleep apnoea (CSA) often have poor quality of life and are at increased risk of morbidity and mortality. This study sought to evaluate the 12-month clinical outcomes of patients with CSA treated with unilateral transvenous phrenic nerve stimulation in the prospective, multicentre, non-randomized remedē ® System pilot study. Forty-seven patients with CSA were treated with the remedē ® System (Respicardia Inc., Minnetonka, MN, USA) for a minimum of 3 months. Sleep-disordered breathing parameters were evaluated by polysomnography (PSG) at 3, 6, and 12-month follow-up. Sleep symptoms and quality of life were also evaluated. Forty-one patients completed all follow-up PSGs and were included in the analysis. At 12 months, there was sustained improvement compared with baseline in the apnoea-hypopnoea index (49.9 ± 15.1 vs. 27.5 ± 18.3 events/h, P phrenic nerve stimulation is associated with sustained improvement in key sleep parameters, sleep symptoms, and quality of life over 12 months of follow-up. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

  4. Oscillatory Dynamics Underlying Perceptual Narrowing of Native Phoneme Mapping from 6 to 12 Months of Age.

    Science.gov (United States)

    Ortiz-Mantilla, Silvia; Hämäläinen, Jarmo A; Realpe-Bonilla, Teresa; Benasich, April A

    2016-11-30

    During the first months of life, human infants process phonemic elements from all languages similarly. However, by 12 months of age, as language-specific phonemic maps are established, infants respond preferentially to their native language. This process, known as perceptual narrowing, supports neural representation and thus efficient processing of the distinctive phonemes within the sound environment. Although oscillatory mechanisms underlying processing of native and non-native phonemic contrasts were recently delineated in 6-month-old infants, the maturational trajectory of these mechanisms remained unclear. A group of typically developing infants born into monolingual English families, were followed from 6 to 12 months and presented with English and Spanish syllable contrasts varying in voice-onset time. Brain responses were recorded with high-density electroencephalogram, and sources of event-related potential generators identified at right and left auditory cortices at 6 and 12 months and also at frontal cortex at 6 months. Time-frequency analyses conducted at source level found variations in both θ and γ ranges across age. Compared with 6-month-olds, 12-month-olds' responses to native phonemes showed smaller and faster phase synchronization and less spectral power in the θ range, and increases in left phase synchrony as well as induced high-γ activity in both frontal and left auditory sources. These results demonstrate that infants become more automatized and efficient in processing their native language as they approach 12 months of age via the interplay between θ and γ oscillations. We suggest that, while θ oscillations support syllable processing, γ oscillations underlie phonemic perceptual narrowing, progressively favoring mapping of native over non-native language across the first year of life. During early language acquisition, typically developing infants gradually construct phonemic maps of their native language in auditory cortex. It is well

  5. Predictors of pain and physical function at 3 and 12 months after total hip arthroplasty

    DEFF Research Database (Denmark)

    Plews, Sarah; Løvlund Nielsen, Randi; Overgaard, Søren

    Background: Few studies have combined preoperative patient-reported and objective outcome measures to predict outcomes after total hip arthroplasty (THA). Purpose / Aim of Study: to identify predictors of outcome 3 and 12 months after THA Materials and Methods: A cohort of 107 consecutive patients...... with primary hip osteoarthritis responded to Hip dysfunction and Osteoarthritis Outcome Score (HOOS) questionnaires prior to and 3 and 12 months after THA. Preoperative pain intensity; joint space width (JSW), age, gender, and body mass index (BMI) were used to predict changes in pain and physical function....... Conclusions: Preoperative pain predicted changes in pain and physical function up to one year after THA. Such knowledge should be taken into consideration, when assessing OA patients prior to surgery. This study provides useful insight for clinicians, regarding the overall improvement patients can expect...

  6. 12-month efficacy of a single radiofrequency ablation on autonomously functioning thyroid nodules.

    Science.gov (United States)

    Bernardi, Stella; Stacul, Fulvio; Michelli, Andrea; Giudici, Fabiola; Zuolo, Giulia; de Manzini, Nicolò; Dobrinja, Chiara; Zanconati, Fabrizio; Fabris, Bruno

    2017-09-01

    Radiofrequency ablation has been advocated as an alternative to radioiodine and/or surgery for the treatment of autonomously functioning benign thyroid nodules. However, only a few studies have measured radiofrequency ablation efficacy on autonomously functioning benign thyroid nodules. The aim of this work was to evaluate the 12-month efficacy of a single session of radiofrequency ablation (performed with the moving shot technique) on solitary autonomously functioning benign thyroid nodules. Thirty patients with a single, benign autonomously functioning benign thyroid nodules, who were either unwilling or ineligible to undergo surgery and radioiodine, were treated with radiofrequency ablation between April 2012 and May 2015. All the patients underwent a single radiofrequency ablation, performed with the 18-gauge needle and the moving shot technique. Clinical, laboratory, and ultrasound evaluations were scheduled at baseline, and after 1, 3, 6, and 12 months from the procedure. A single radiofrequency ablation reduced thyroid nodule volume by 51, 63, 69, and 75 % after 1, 3, 6, and 12 months, respectively. This was associated with a significant improvement of local cervical discomfort and cosmetic score. As for thyroid function, 33 % of the patients went into remission after 3 months, 43 % after 6 months, and 50 % after 12 months from the procedure. This study demonstrates that a single radiofrequency ablation allowed us to withdraw anti-thyroid medication in 50 % of the patients, who remained euthyroid afterwards. This study shows that a single radiofrequency ablation was effective in 50 % of patients with autonomously functioning benign thyroid nodules. Patients responded gradually to the treatment. It is possible that longer follow-up studies might show greater response rates.

  7. Beta blocker therapy is associated with reduced depressive symptoms 12 months post percutaneous coronary intervention.

    Science.gov (United States)

    Battes, Linda C; Pedersen, Susanne S; Oemrawsingh, Rohit M; van Geuns, Robert J; Al Amri, Ibtihal; Regar, Evelyn; de Jaegere, Peter P T; Serruys, Patrick; van Domburg, Ron T

    2012-02-01

    Beta blocker therapy may induce depressive symptoms, although current evidence is conflicting. We examined the association between beta blocker therapy and depressive symptoms in percutaneous coronary intervention (PCI) patients and the extent to which there is a dose-response relationship between beta blocker dose and depressive symptoms. Patients treated with PCI (N=685) completed the depression scale of the Hospital Anxiety and Depression Scale 1 and 12 months post PCI. Information about type and dose of beta blocker use was extracted from medical records. Of all patients, 68% (466/685) were on beta blocker therapy at baseline. In adjusted analysis, beta blocker use at 1 month post PCI (OR: 0.82; 95% CI: 0.53-1.26) was not significantly associated with depressive symptoms. At 12 months post PCI, there was a significant relationship between beta blocker use and depressive symptoms (OR: 0.51; 95% CI: 0.31-0.84), with beta blocker therapy associated with a 49% risk reduction in depressive symptoms. There was a dose-response relationship between beta blocker dose and depressive symptoms 12 months post PCI, with the risk reduction in depressive symptoms in relation to a low dose being 36% (OR: 0.64; 95% CI: 0.37-1.10) and 58% (OR: 0.42; 95% CI: 0.24-0.76) in relation to a high dose. Patients treated with beta blocker therapy were less likely to experience depressive symptoms 12 months post PCI, with there being a dose-response relationship with a higher dose providing a more pronounced protective effect. Copyright © 2011 Elsevier B.V. All rights reserved.

  8. Headache patients' satisfaction with telemedicine: a 12-month follow-up randomized non-inferiority trial.

    Science.gov (United States)

    Müller, K I; Alstadhaug, K B; Bekkelund, S I

    2017-06-01

    We investigated non-acute headache patients' long-term satisfaction with a telemedicine consultation and consultation preferences in northern Norway. We hypothesized that patients were not less satisfied with telemedicine than traditional consultations. We also examined the influence of gender, age and education on satisfaction. For 2.5 years, patients were consecutively screened, recruited and randomly assigned to telemedicine or traditional visits with a consultation at a neurological outpatient department. The primary endpoint was frequency of satisfied patients at 3 and 12 months. Secondary endpoints were satisfaction with consultation, communication, information, diagnosis, advice and prescriptions, and preferred visit form at 12 months. Of 402 participants, 279 (69.4%) answered questionnaires at both 3 and 12 month, and 291 (72.4%) responded at 12 months. The long-term satisfaction of telemedicine patients was 124/145 (85.5%) compared with 118/134 (88.1%) in the traditional group (P = 0.653). The groups did not differ with respect to secondary endpoints, but females were more satisfied with telemedicine communication (P = 0.027). In the telemedicine group, 99/147 (67.3%) were indifferent to the type of consultation. Age and education did not alter the primary results. At 1 year after a specialist evaluation for headache, telemedicine patients did not express less satisfaction than those with traditional consultation. Telemedicine specialist consultations may be a good alternative for headache patients in secondary care. © 2017 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

  9. Assessment of Gastroesophageal Reflux in Children(2-12 Month) Based on Clinical Findings and Ultrasonography

    OpenAIRE

    F Jassemi Zergani; R Farahi Rostami; F Hakim; Z Jannat Alipour; K Karimi; Z Fotokian

    2012-01-01

    Introduction: Gastroesophageal reflux is a common gastrointestinal disorder among infants, which can cause complications, such as esophagitis and Barrett's esophagus if its diagnosis and treatment are delayed. On the other hand, similarity of Gastro esophageal Reflux symptoms with symptoms of other childhood diseases makes its diagnosis and treatment difficult. So a proper tool for early screening and diagnostic test is essential. Methods: This study was conducted on 221 infants(2 to 12 month...

  10. Improvement in GOS and GOSE scores 6 and 12 months after severe traumatic brain injury.

    Science.gov (United States)

    Corral, Luisa; Ventura, José Luis; Herrero, José Ignacio; Monfort, Jose Luis; Juncadella, Montserrat; Gabarrós, Andreu; Bartolomé, Carlos; Javierre, Casimiro F; García-Huete, Lucía

    2007-11-01

    To assess improvements in Glasgow Outcome Scale (GOS) and GOS extended (GOSE) scores between 6 months and 1 year following severe traumatic brain injury (TBI). One studied 214 adult patients with severe TBI with Glasgow Coma Scale (GCS) GOSE at 6 months and 1 year) was better in the high GCS score at admission (6-8) group than in the low score group (3-5). The improvement in GOS scores between 6 months and 1 year was greater in the high GCS score at admission group than in the low score group. At 6 months, 75 patients had died and 120 survived. None died between the 6-12-month assessments; at 12 months, 36% had improved GOS score. GOS scores improved between 6-12 months after severe TBI in 36% of survivors and it is concluded that the expectancy of improvement is incomplete at 6 months. This improvement was greater in patients with better GCS scores (6-8) at admission than in those with worse GCS scores (3-5).

  11. Utility of an Abbreviated Dizziness Questionnaire to Differentiate Between Causes of Vertigo and Guide Appropriate Referral: A Multicenter Prospective Blinded Study.

    Science.gov (United States)

    Roland, Lauren T; Kallogjeri, Dorina; Sinks, Belinda C; Rauch, Steven D; Shepard, Neil T; White, Judith A; Goebel, Joel A

    2015-12-01

    Test performance of a focused dizziness questionnaire's ability to discriminate between peripheral and nonperipheral causes of vertigo. Prospective multicenter. Four academic centers with experienced balance specialists. New dizzy patients. A 32-question survey was given to participants. Balance specialists were blinded and a diagnosis was established for all participating patients within 6 months. Multinomial logistic regression was used to evaluate questionnaire performance in predicting final diagnosis and differentiating between peripheral and nonperipheral vertigo. Univariate and multivariable stepwise logistic regression were used to identify questions as significant predictors of the ultimate diagnosis. C-index was used to evaluate performance and discriminative power of the multivariable models. In total, 437 patients participated in the study. Eight participants without confirmed diagnoses were excluded and 429 were included in the analysis. Multinomial regression revealed that the model had good overall predictive accuracy of 78.5% for the final diagnosis and 75.5% for differentiating between peripheral and nonperipheral vertigo. Univariate logistic regression identified significant predictors of three main categories of vertigo: peripheral, central, and other. Predictors were entered into forward stepwise multivariable logistic regression. The discriminative power of the final models for peripheral, central, and other causes was considered good as measured by c-indices of 0.75, 0.7, and 0.78, respectively. This multicenter study demonstrates a focused dizziness questionnaire can accurately predict diagnosis for patients with chronic/relapsing dizziness referred to outpatient clinics. Additionally, this survey has significant capability to differentiate peripheral from nonperipheral causes of vertigo and may, in the future, serve as a screening tool for specialty referral. Clinical utility of this questionnaire to guide specialty referral is discussed.

  12. Effect of the pringle maneuver on tumor recurrence of hepatocellular carcinoma after curative resection (EPTRH): a randomized, prospective, controlled multicenter trial

    International Nuclear Information System (INIS)

    Xiaobin, Feng; Shuguang, Wang; Ping, Bie; Jiahong, Dong; Shuguo, Zheng; Jian, Zhou; Yudong, Qiu; Lijian, Liang; Kuansheng, Ma; Xiaowu, Li; Feng, Xia; Dong, Yi

    2012-01-01

    Hepatic resection is currently still the best choice of therapeutic strategies for liver cancer, but the long-term survival rate after surgery is unsatisfactory. Most patients develop intra- and/or extrahepatic recurrence. The reasons for this high recurrence rate are not entirely clear. Recent studies have indicated that ischemia-reperfusion injury to the liver may be a significant factor promoting tumor recurrence and metastasis in animal models. If this is also true in humans, the effects of the Pringle maneuver, which has been widely used in hepatectomy for the past century, should be examined. To date, there are no reported data or randomized controlled studies examining the relationship between use of the Pringle maneuver and local tumor recurrence. We hypothesize that the long-term prognosis of patients with liver cancer could be worsened by use of the Pringle maneuver due to an increase in the rate of tumor recurrence in the liver remnant. We designed a multicenter, prospective, randomized surgical trial to test this hypothesis. At least 498 eligible patients from five participating centers will be enrolled and randomized into either the Pringle group or the non-Pringle group in a ratio of 1:1 using a permuted-blocks randomization protocol. After the completion of surgical intervention, patients will be included in a 3-year follow-up program. This multicenter surgical trial will examine whether the Pringle maneuver has a negative effect on the long-term outcome of hepatocellular carcinoma patients. The trial will also provide information about prognostic differences, safety, advantages and disadvantages between Pringle and non-Pringle surgical procedures. Ultimately, the results will increase the available information about the effects of ischemia-reperfusion injury on tumor recurrence, which will be of immense benefit to general surgery.

  13. Effect of Exercise on Serum Sex Hormones in Men: A 12-Month Randomized Clinical Trial

    Science.gov (United States)

    HAWKINS, VIVIAN N.; FOSTER-SCHUBERT, KAREN; CHUBAK, JESSICA; SORENSEN, BESS; ULRICH, CORNELIA M.; STANCYZK, FRANK Z.; PLYMATE, STEPHEN; STANFORD, JANET; WHITE, EMILY; POTTER, JOHN D.; MCTIERNAN, ANNE

    2011-01-01

    Purpose The effect of exercise on androgens in middle-aged to older men is poorly understood, and it could have implications for several aspects of health. This analysis was conducted to examine the effects of long-term aerobic exercise on serum sex hormones in middle-aged to older men. Methods One hundred two sedentary men, ages 40–75 yr, were randomly assigned to a 12-month exercise intervention or a control group (no change in activity). The combined facility- and home-based exercise program consisted of moderate/vigorous-intensity aerobic activity for 60 min·d−1, 6 d·wk−1. Serum concentrations of testosterone, free testosterone, dihydrotestosterone (DHT), 3α-androstanediol glucuronide (3α-Diol-G), estradiol, free estradiol, and sex hormone–binding globulin (SHBG) were measured at baseline, 3, and 12 months. Results Exercisers trained a mean of 370 min·wk−1 (102% of goal), with only two dropouts. Cardiopulmonary fitness (V̇O2max) increased 10.8% in exercisers and decreased by 1.8% in controls (P < 0.001). DHT increased 14.5% in exercisers versus 1.7% in controls at 3 months (P = 0.04); at 12 months, it remained 8.6% above baseline in exercisers versus a 3.1% decrease in controls (P = 0.03). SHBG increased 14.3% in exercisers versus 5.7% in controls at 3 months (P = 0.04); at 12 months, it remained 8.9% above baseline in exercisers versus 4.0% in controls (P = 0.13). There were significant trends toward increasing DHT and SHBG, with greater increases in V̇O2max at 3 and 12 months in exercisers. No statistically significant differences were observed for testosterone, free testosterone, 3α-Diol-G, estradiol, or free estradiol in exercisers versus controls. Conclusions A yearlong, moderate-intensity aerobic exercise program increased DHT and SHBG, but it had no effect on other androgens in middle-aged to older men. PMID:18202581

  14. Physical health after childbirth and maternal depression in the first 12 months post partum: results of an Australian nulliparous pregnancy cohort study.

    Science.gov (United States)

    Woolhouse, Hannah; Gartland, Deirdre; Perlen, Susan; Donath, Susan; Brown, Stephanie J

    2014-03-01

    to investigate the relationship between maternal physical health problems and depressive symptoms in the first year after childbirth. prospective pregnancy cohort study. Melbourne, Victoria, Australia. 1507 nulliparous women. women were recruited from six public hospitals between six and 24 weeks gestation. Written questionnaires were completed at recruitment and at three, six and 12 months post partum. Edinburgh Postnatal Depression Scale (EPDS); standardised measures of urinary and faecal incontinence, a checklist of symptoms for other physical health problems. overall, 16.1% of women reported depressive symptoms during the first 12 months post partum, with point prevalence at three, six and 12 months post partum of 6.9%, 8.8% and 7.8% respectively. The most commonly reported physical health problems in the first three months were tiredness (67%), back pain (47%), breast problems (37%), painful perineum (30%), and urinary incontinence (29%). Compared with women reporting 0-2 health problems in the first three months post partum, women reporting 5 or more health problems had a six-fold increase in likelihood of reporting concurrent depressive symptoms at three months post partum (Adjusted OR=6.69, 95% CI=3.0-15.0) and a three-fold increase in likelihood of reporting subsequent depressive symptoms at 6-12 months post partum (Adjusted OR=3.43, 95% CI 2.1-5.5). poor physical health in the early postnatal period is associated with poorer mental health throughout the first 12 months post partum. Early intervention to promote maternal mental health should incorporate assessment and intervention to address common postnatal physical health problems. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

    Science.gov (United States)

    Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

    2016-05-01

    Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6

  16. A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

    Science.gov (United States)

    Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

    2018-04-01

    Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

  17. Communication and coping as predictors of fertility problem stress: cohort study of 816 participants who did not achieve a delivery after 12 months of fertility treatment

    DEFF Research Database (Denmark)

    Schmidt, L; Holstein, B E; Christensen, Ulla

    2005-01-01

    BACKGROUND: We investigated coping strategies and communication strategies as predictors of fertility problem stress 12 months after start of fertility treatment. METHODS: We used a prospective, longitudinal cohort design including 2250 people beginning fertility treatment with a 12-month follow......-up. Data were based on self-administered questionnaires measuring communication with partner and with other people, coping strategies: active-avoidance coping, active-confronting coping, passive-avoidance coping, meaning-based coping, and fertility problem stress. The study population included those...... participants (n = 816, men and women) who had not achieved pregnancy by assisted reproduction or delivery at follow-up. RESULTS: Among both men and women, difficulties in partner communication predicted high fertility problem stress (odds ratio for women, 3.47, 95% confidence interval 2.09-5.76; odds ratio...

  18. Miglustat in late-onset Tay-Sachs disease: a 12-month, randomized, controlled clinical study with 24 months of extended treatment.

    Science.gov (United States)

    Shapiro, Barbara E; Pastores, Gregory M; Gianutsos, John; Luzy, Cécile; Kolodny, Edwin H

    2009-06-01

    To evaluate the safety and efficacy of miglustat in patients with GM2 gangliosidosis. A randomized, multicenter, open-label, 12-month study involving patients aged 18 years or older, randomized 2:1 to miglustat (200 mg TID) or "no miglustat treatment." This study was followed by 24 months of extended treatment during which all patients received miglustat. Primary efficacy endpoints were change in eight measures of isometric muscle strength in the limbs and isometric grip strength, evaluated at baseline, and months 12 and 36. Secondary efficacy endpoints included gait, balance, disability, and other neurological assessments. Safety evaluations included adverse event reporting. Thirty patients (67% male, age range 18-56 years) with late-onset Tay-Sachs disease were enrolled; 20 were randomized to miglustat and 10 to "no miglustat treatment." Muscle and grip strength generally decreased over the study period. No differences were observed between the two groups in any efficacy measure, either during the 12-month randomized phase or the full 36 months. The most common treatment-related adverse events were decrease in weight and diarrhea. Miglustat treatment was not shown to lead to measurable benefits in this cohort of patients with late-onset Tay-Sachs disease. The observed safety profile was consistent with that of the approved dose (100 mg TID) in type 1 Gaucher disease.

  19. Newly identified psychiatric illness in one general practice: 12-month outcome and the influence of patients' personality.

    Science.gov (United States)

    Wright, A F; Anderson, A J

    1995-01-01

    BACKGROUND. Relatively little is known about the natural history and outcome of psychological problems in patients who present to general practitioners. Only a small proportion of such patients are seen by specialists. Clinical experience suggests that patient personality is one of the factors influencing outcome in patients diagnosed as having psychiatric illness. AIM. This study set out to examine prospectively the progress and 12-month outcome of patients with newly identified psychiatric illness, and the association of patients' personality with outcome. METHOD. One hundred and seventy one patients with clinically significant psychiatric illness attending one practice in a Scottish new town were followed up prospectively (96 presented with psychological symptoms and 75 with somatic symptoms), and were compared with a group of 127 patients with chronic physical illness. Patients were assessed in terms of psychiatric state, social problems and personality using both computer-based and pencil and paper tests in addition to clinical assessments at each consultation during the follow-up year and structured interview one year after recruitment. RESULTS. Most of the improvement in psychiatric state scores on the 28-item general health questionnaire occurred in the first six months of the illness. Of the 171 patients with psychiatric illness 34% improved quickly and remained well, 54% had an intermittent course but had improved at 12-month follow up while 12% pursued a chronic course without improvement. The mean number of consultations in the follow-up year was 8.4 for patients presenting with psychological symptoms, 7.2 for those presenting with somatic symptoms and 6.6 for patients with chronic physical illness. The Eysenck N score proved a strong predictor of the outcome of new psychiatric illness. CONCLUSION. Only one in three patients with newly identified psychiatric illness improved quickly and and remained well, reflecting the importance of continuing care of

  20. CUMULATIVE TRAUMAS AND RISK THRESHOLDS: 12-MONTH PTSD IN THE WORLD MENTAL HEALTH (WMH) SURVEYS

    Science.gov (United States)

    Karam, Elie G.; Friedman, Matthew J.; Hill, Eric D.; Kessler, Ronald C.; McLaughlin, Katie A.; Petukhova, Maria; Sampson, Laura; Shahly, Victoria; Angermeyer, Matthias C.; Bromet, Evelyn J.; de Girolamo, Giovanni; de Graaf, Ron; Demyttenaere, Koen; Ferry, Finola; Florescu, Silvia E.; Haro, Josep Maria; He, Yanling; Karam, Aimee N.; Kawakami, Norito; Kovess-Masfety, Viviane; Medina-Mora, María Elena; Browne, Mark A. Oakley; Posada-Villa, José A.; Shalev, Arieh Y.; Stein, Dan J.; Viana, Maria Carmen; Zarkov, Zahari; Koenen, Karestan C.

    2014-01-01

    Background Clinical research suggests that posttraumatic stress disorder (PTSD) patients exposed to multiple traumatic events (TEs) rather than a single TE have increased morbidity and dysfunction. Although epidemiological surveys in the United States and Europe also document high rates of multiple TE exposure, no population-based cross-national data have examined this issue. Methods Data were analyzed from 20 population surveys in the World Health Organization World Mental Health Survey Initiative (n 51,295 aged 18+). The Composite International Diagnostic Interview (3.0) assessed 12-month PTSD and other common DSM-IV disorders. Respondents with 12-month PTSD were assessed for single versus multiple TEs implicated in their symptoms. Associations were examined with age of onset (AOO), functional impairment, comorbidity, and PTSD symptom counts. Results 19.8% of respondents with 12-month PTSD reported that their symptoms were associated with multiple TEs. Cases who associated their PTSD with four or more TEs had greater functional impairment, an earlier AOO, longer duration, higher comorbidity with mood and anxiety disorders, elevated hyper-arousal symptoms, higher proportional exposures to partner physical abuse and other types of physical assault, and lower proportional exposure to unexpected death of a loved one than cases with fewer associated TEs. Conclusions A risk threshold was observed in this large-scale cross-national database wherein cases who associated their PTSD with four or more TEs presented a more “complex” clinical picture with substantially greater functional impairment and greater morbidity than other cases of PTSD. PTSD cases associated with four or more TEs may merit specific and targeted intervention strategies. Depression and Anxiety 31:130–142, 2014. PMID:23983056

  1. Effect of omega-3 supplementation on neuropathy in type 1 diabetes: A 12-month pilot trial.

    Science.gov (United States)

    Lewis, Evan J H; Perkins, Bruce A; Lovblom, Leif E; Bazinet, Richard P; Wolever, Thomas M S; Bril, Vera

    2017-06-13

    To test the hypothesis that 12 months of seal oil omega-3 polyunsaturated fatty acids (ω-3 PUFA) supplementation will stop the known progression of diabetic sensorimotor polyneuropathy (DSP) in type 1 diabetes mellitus (T1DM). Individuals with T1DM and evidence of DSP as determined by a Toronto Clinical Neuropathy Score ≥1 were recruited to participate in a single-arm, open-label trial of seal oil ω-3 PUFA supplementation (10 mL·d -1 ; 750 mg eicosapentaenoic acid, 560 mg docosapentaenoic acid, and 1,020 mg docosahexaenoic acid) for 1 year. The primary outcome was the 1-year change in corneal nerve fiber length (CNFL) measured by in vivo corneal confocal microscopy, with sensory and nerve conduction measures as secondary outcomes. Forty participants (53% female), aged 48 ± 14 years, body mass index 28.1 ± 5.8 with diabetes duration of 27 ± 18 years, were enrolled. At baseline, 23 participants had clinical DSP and 17 did not. Baseline CNFL was 8.3 ± 2.9 mm/mm 2 and increased 29% to 10.1 ± 3.7 mm/mm 2 ( p = 0.002) after 12 months of supplementation. There was no change in nerve conduction or sensory function. Twelve months of ω-3 supplementation was associated with increase in CNFL in T1DM. NCT02034266. This study provides Class IV evidence that for patients with T1DM and evidence of DSP, 12 months of seal oil omega-3 supplementation increases CNFL. © 2017 American Academy of Neurology.

  2. Histamine-dependent behavioral response to methamphetamine in 12-month-old male mice

    Science.gov (United States)

    Acevedo, Summer F.; Raber, Jacob

    2011-01-01

    Methamphetamine (MA) use is a growing problem across the United States. Effects of MA include hyperactivity and increased anxiety. Using a mouse model system, we examined behavioral performance in the open field and elevated zero maze and shock-startle response of 12-month-old wild-type mice injected with MA once (1mg/kg) 30 min prior to behavioral testing. MA treatment resulted in behavioral sensitization in the open field, consistent with studies in younger mice. There was an increased activity in the elevated zero maze and an increased shock-startle response 30 and 60 min post-injection. Since histamine mediates some effects of MA in the brain, we assessed whether 12-month-old mice lacking histidine decarboxylase (Hdc−/−), the enzyme required to synthesize histamine, respond differently to MA than wild-type (Hdc+/+) mice. Compared to saline treatment, acute and repeated MA administration increased activity in the open field and measures of anxiety, though more so in Hdc−/− than Hdc+/+ mice. In the elevated zero maze, opposite effects of MA on activity and measures of anxiety were seen in Hdc+/+ mice. In contrast, MA similarly increased the shock-startle response in Hdc−/− and Hdc+/+ mice, compared to saline-treated genotype-matched mice. These results are similar to those in younger mice suggesting that the effects are not age-dependent. Overall, single or repeated MA treatment causes histamine-dependent changes in 12-month-old mice in the open field and elevated zero-maze, but not in the shock-startle response. PMID:21466792

  3. Prognosis at 6 and 12months after self-attempted hanging.

    Science.gov (United States)

    Gantois, Guillaume; Parmentier-Decrucq, Erika; Duburcq, Thibault; Favory, Raphaël; Mathieu, Daniel; Poissy, Julien

    2017-11-01

    Patients surviving a self-attempted hanging have a total neurological recovery in 57-77% of cases at hospital discharge, but no long-term data are available. In this observational study, all patients hospitalized post-self-attempted hanging in the intensive care unit (ICU) in a 5-year period were included. Neurological evaluations at 6 and 12months were performed according to Cerebral Performance Category (CPC) scores. Factors associated with neurological recovery were determined by comparing CPC2+3+4 (bad recovery) vs. CPC1 (good recovery). Of 231 patients included, 104 (47%) were found to have cardiac arrest (CA). Ninety-five (41%) patients died in the ICU: 93 (89%) in the CA group and 2 (1.6%) in the group without CA. Neurological evaluations at 6 and 12months were obtained in 97 of the 136 surviving patients. At 6months, in the CA group (n=9), the CPC score was 1 for 6 patients, 2 for 2, and 4 for 1 patient. In the group without CA (n=88), 79 patients had normal neurological status at 6months and 78 at 12months. Among these patients, 96% returned home, 77% returned to work, 16 (18%) patients re-attempted suicide within the year. Risk factors of neurological sequelae at 6months were a CA at the hanging site (P=0.045), an elevated diastolic blood pressure (87 vs. 70 mm Hg; P=0.04), a lower initial Glasgow score (4 vs. 5; P=0.04), and an elevated blood glucose level (139 vs. 113 mg/dL; Pgood neurological outcome. The rate of suicidal recidivism is particularly important, which justifies joint work with psychiatrists. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. Community participation of patients 12 months post-stroke in Johannesburg, South Africa

    Directory of Open Access Journals (Sweden)

    Witness Mudzi

    2013-01-01

    Full Text Available Background: Improvement in health-related quality of life (HRQL is the main goal of rehabilitation. The ability of the stroke-patient to participate in various situations signifies successful rehabilitation. The aim of the study was to establish the extent of communityparticipation and the barriers and facilitators to the participation for stroke patients after their discharge.Method: This study formed part of a larger study focusing on the impact of caregiver education on stroke survivors and their careers. This was a longitudinal study comprising 200 patients with first-time ischaemic stroke. Although the patients were followed up at home at 3 months, 6 months and 12 months post-stroke, this paper focuses on the 12-months follow-up participation results. Patient functional ability was measured by using the Barthel Index (BI and the Rivermead Mobility Index (RMI, whereas participation was measured by using the International Classification of Functioning, Disability and Health (ICF checklist. Descriptive statistics were used to analyse the data.Results: Patients experienced severe to complete difficulty when undertaking single and multiple tasks without help 12-months post-discharge. They struggled with the preparation of meals, household work and interpersonal interactions, and they had difficulties withcommunity life and partaking in recreation and leisure activities. Immediate family and societal attitudes were viewed as facilitators to community participation whereas friends, transportation services and social security services were viewed as barriers to communityparticipation.Conclusion: The patient-ability to socialise and participate in community issues is currently poor. The identified barriers to community participation need to be addressed in order toimprove patient-participation in the community post-stroke.

  5. Ospemifene 12-month safety and efficacy in postmenopausal women with vulvar and vaginal atrophy

    DEFF Research Database (Denmark)

    Goldstein, S R; Bachmann, G A; Koninckx, P R

    2014-01-01

    OBJECTIVE: Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA). METHODS: In this 52-week, randomized, double-blind, placebo-controlled, parallel-group study, women 40-80 years with VVA and an intact uterus were randomized...... baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH. RESULTS: Of 426 randomized subjects, 81.9% (n = 349) completed the study with adverse events the most common reason for discontinuation (ospemifene 9.5%; placebo 3.9%). Most (88%) treatment-emergent adverse events...

  6. Evaluation of radurizited and pasteurized fruits juices during 12 months of storage

    International Nuclear Information System (INIS)

    Wilska-Jeszka, J.; Skorupinska, A.

    1975-01-01

    Stability of radurized red and black currant, bilberry, plum and tomato juices, stored at a temperature of 20+-3 0 C, was investigated. With 60 Co as radiation source, doses of 0,5 to 1,5 Mrad were applied. In a 12-month period no significant changes in pH, total and volatile acidity were found. Anthocyanic pigment and ascorbic acid losses were greater in radurized than in pasteurized juices. No organoleptic changes occurred after irradiation with 1 Mrad in tomato juices, very little change in plum and bilberry juices and considerable unfavorable changes in currant juice

  7. Long-term memory, forgetting, and deferred imitation in 12-month-old infants

    OpenAIRE

    Klein, Pamela J.; Meltzoff, Andrew N.

    1999-01-01

    Long-term recall memory, as indexed by deferred imitation, was assessed in 12-month-old infants. Independent groups of infants were tested after retention intervals of 3 min, 1 week and 4 weeks. Deferred imitation was assessed using the ‘observation-only’ procedure in which infants were not allowed motor practice on the tasks before the delay was imposed. Thus, the memory could not have been based on re-accessing a motor habit, because none was formed in the first place. After the delay, memo...

  8. Prospective assessment of clinical symptoms associated with enterovirus and parechovirus genotypes in a multicenter study in Dutch children

    NARCIS (Netherlands)

    de Crom, S. C. M.; Rossen, J. W. A.; de Moor, R. A.; Veldkamp, E. J. M.; van Furth, A. M.; Obihara, C. C.

    Background: Human non-polio enterovirus (EV) and human parechovirus (HPeV) are important pathogens viral infection and aseptic meningitis in children. The aim of this study is to prospectively compare the incidence, clinical signs, blood and cerebrospinal fluid in EV and HPeV infected children.

  9. Considering abortion: a 12-month audit of records of women contacting a Pregnancy Advisory Service.

    Science.gov (United States)

    Rowe, Heather J; Kirkman, Maggie; Hardiman, E Annarella; Mallett, Shelley; Rosenthal, Doreen A

    2009-01-19

    To characterise the demographic and psychosocial circumstances of women contacting Victoria's largest public pregnancy advisory service (PAS). Audit of PAS electronic records for the 12 months from 1 October 2006 to 30 September 2007. De-identified data were extracted from a comprehensive electronic database used for recording consultations. Summary statistics and measures of association. During the 12 months, 5462 women contacted PAS; records were created for 3827 women, and data were available in more than 80% of records for 77% (13/17) of items. Over half of the women receiving pregnancy support from PAS (60%) were 18-29 years old; 12% lived outside the metropolitan area; 51% held a health care card, and smaller percentages faced housing, financial, or drug and alcohol problems; 16% reported violence, but 71% described partners as involved and supportive. Most (79%) made contact within 2 weeks of discovering pregnancy, and 72% were referred by a general practitioner. Later gestation at contact was associated with younger age (P abortion were the desire to delay pregnancy (23%) and family completion (18%); 42% already had at least one child. Twenty-three women reported that the pregnancy was the result of rape. Ten per cent had mental health problems, and smaller numbers faced access barriers and had special needs. This PAS responds to demand from women with diverse social and personal circumstances. Findings provide evidence for policy, prevention and service development.

  10. Does contingency in adults' responding influence 12-month-old infants' social referencing?

    Science.gov (United States)

    Stenberg, Gunilla

    2017-11-01

    In two experiments we examined the influence of contingent versus non-contingent responding on infant social referencing behavior. EXPERIMENT 1: Forty 12-month-old infants were exposed to an ambiguous toy in a social referencing situation. In one condition an unfamiliar adult who in a previous play situation had responded contingently to the infant's looks gave the infant positive information about the toy. In the other condition an unfamiliar adult who previously had not responded contingently delivered the positive information. EXPERIMENT 2: Forty-eight 12-month-old infants participated in Experiment 2. In this experiment it was examined whether the familiarity of the adult influences infants' reactions to contingency in responding. In one condition a parent who previously had responded contingently to the infant's looks provided positive information about the ambiguous toy, and in the other condition a parent who previously had not responded contingently provided the positive information. The infants looked more at the contingent experimenter in Experimenter 1, and also played more with the toy after receiving positive information from the contingent experimenter. No differences in looking at the parent and in playing with the toy were found in Experiment 2. The results indicate that contingency in responding, as well as the familiarity of the adult, influence infants' social referencing behavior. Copyright © 2017 Elsevier Inc. All rights reserved.

  11. The relationship between attention and deferred imitation in 12-month-old infants.

    Science.gov (United States)

    Zmyj, Norbert; Schölmerich, Axel; Daum, Moritz M

    2017-08-01

    Imitation is a frequent behavior in the first years of life, and serves both a social function (e.g., to interact with others) and a cognitive function (e.g., to learn a new skill). Infants differ in their temperament, and temperament might be related to the dominance of one function of imitation. In this study, we investigated whether temperament and deferred imitation are related in 12-month-old infants. Temperament was measured via the Infant Behavior Questionnaire Revised (IBQ-R) and parts of the Laboratory Temperament Assessment Battery (Lab-TAB). Deferred imitation was measured via the Frankfurt Imitation Test for 12-month-olds (FIT-12). Regression analyses revealed that the duration of orienting (IBQ-R) and the latency of the first look away in the Task Orientation task (Lab-TAB) predicted the infants' imitation score. These results suggest that attention-related processes may play a major role when infants start to imitate. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Distress among women receiving uninformative BRCA1/2 results: 12-month outcomes.

    Science.gov (United States)

    O'Neill, Suzanne C; Rini, Christine; Goldsmith, Rachel E; Valdimarsdottir, Heiddis; Cohen, Lawrence H; Schwartz, Marc D

    2009-10-01

    Few data are available regarding the long-term psychological impact of uninformative BRCA1/2 test results. This study examines change in distress from pretesting to 12-months post-disclosure, with medical, family history, and psychological variables, such as pretesting perceived risk of carrying a deleterious mutation prior to testing and primary and secondary appraisals, as predictors. Two hundred and nine women with uninformative BRCA1/2 test results completed questionnaires at pretesting and 1-, 6-, and 12-month post-disclosure, including measures of anxiety and depression, cancer-specific and genetic testing distress. We used a mixed models approach to predict change in post-disclosure distress. Distress declined from pretesting to 1-month post-disclosure, but remained stable thereafter. Primary appraisals predicted all types of distress at 1-month post-disclosure. Primary and secondary appraisals predicted genetic testing distress at 1-month as well as change over time. Receiving a variant of uncertain clinical significance and entering testing with a high expectation for carrying a deleterious mutation predicted genetic testing distress that persisted through the year after testing. As a whole, women receiving uninformative BRCA1/2 test results are a resilient group. For some women, distress experienced in the month after testing does not dissipate. Variables, such as heightened pretesting perceived risk and cognitive appraisals, predict greater likelihood for sustained distress in this group and could be amenable to intervention.

  13. Replicating Reducing the Risk: 12-Month Impacts of a Cluster Randomized Controlled Trial

    Science.gov (United States)

    Blocklin, Michelle; Layzer, Jean; Price, Cristofer; Juras, Randall; Freiman, Lesley

    2016-01-01

    Objectives. To test the effectiveness of Reducing the Risk, an evidence-based sexual health curriculum designed to help prevent adolescent pregnancy and sexually transmitted infections, on youth sexual behavior and intermediate outcomes thought to lead to these behaviors. Methods. Classes within schools in St. Louis, Missouri; Austin, Texas; and San Diego, California; were randomly assigned to receive Reducing the Risk or “business as usual.” Youths completed Web-based surveys at baseline (preintervention, August 2012–January 2014) and 12 months later (August 2013–January 2015). Intent-to-treat analyses were conducted across sites; we tested for differences in impacts between sites and other subgroups. Results. The program had no overall impact on sexual behaviors. However, at 1 site, program participants were significantly less likely to have engaged in recent sexual intercourse than were control group members. There were positive overall impacts on intermediate outcomes (e.g., knowledge, attitudes). Conclusions. After 12 months, Reducing the Risk was unsuccessful at changing sexual behaviors. Other results were mixed, but promising evidence (e.g., behavioral impacts at 1 site, impacts on intermediate outcomes) suggests potential for more widespread behavioral impacts over a longer term. PMID:27689492

  14. Parents’ Experiences of Suicide-Bereavement: A Qualitative Study at 6 and 12 Months after Loss

    Directory of Open Access Journals (Sweden)

    Victoria Ross

    2018-03-01

    Full Text Available The death of a child by suicide is a severe trauma, placing parents at greater risk of psychological morbidity and physical health problems compared to other causes of death. However, few studies have examined the aftermath and bereavement experience for parents following the death of a child to suicide, limiting the ability to guide effective postvention services through empirical research. The current study, which was part of a larger longitudinal investigation of suicide bereavement in Queensland, Australia, examined the individual experiences of both mothers and fathers bereaved by suicide over time, specifically at the six month and 12 month time points after their loss. Bereaved parents who had provided written consent to be contacted for research purposes were identified through the Queensland Suicide Register, and took part in individual, semi-structured interviews. Generic qualitative analysis identified three key themes: searching for answers and sense-making, coping strategies and support, and finding meaning and purpose. Some participants showed indications of meaning-making and post-traumatic growth at 12 months after the suicide. According to the dual process model of bereavement, it is likely that participants were still oscillating between sense-making and meaning making, indicating that adapting to bereavement is a dynamic and fluctuating process.

  15. Corporal and testicular biometry in wild boar from birth to 12 months of age

    Directory of Open Access Journals (Sweden)

    Danillo Velloso Ferreira Murta

    2013-02-01

    Full Text Available The aim of this tudy was to evaluate corporal and testicular development in wild boars (Sus scrofa scrofa from birth to 12 months of age, evaluating body weight, biometric testicular parameters, and gonadosomatic index. Thirty-nine male wild boars from a commercial farm licensed by IBAMA were used in the study. The animals were weighed and assigned to 13 experimental groups. The testes were recovered through unilateral orchiectomy, weighed on an analytical balance and measured for length, width and thickness. Body weight and testicular measures increased with the age, up to 12 months, and were more accelerated in the first and ninth months. Initially the testicular growth pattern, between zero and nine months, followed the body growth, and the gonadosomatic index varied from 0.07 to 0.09%. Between 9 and 11 months, the testicular growth was superior to the body growth, and the gonadosomatic index varied from 0.09 to 0.16%. Finally, after 11 months of age, testicular and body growth had a similar behavior. In conclusion, body weight, testicular biometry, and gonadosomatic index development accelerated in the ninth month.

  16. Changes in knee joint load indices from before to 12 months after arthroscopic partial meniscectomy

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Holsgaard-Larsen, Anders; Creaby, M W

    2016-01-01

    with the contra-lateral leg. METHODS: We estimated indices of knee joint loading (external peak knee adduction moment (KAM), KAM impulse and peak knee flexion moment (KFM)) normalized to body size (i.e., body mass (BM) and height (HT)) using 3D gait analysis in 23 patients (17 men, mean (SD) 46.2 (6.4) years, BMI...... 25.8 (3.4) kg/m(2)) without radiographic knee OA before and 12 months after medial APM. Static alignment was assessed by radiography and self-reported outcomes by Knee injury and Osteoarthritis Outcome Score (KOOS). RESULTS: Peak KAM and KAM impulse increased in the APM leg compared to the contra......-lateral leg from before to 12 months after surgery (change difference: 0.38 Nm/BM*HT% 95% CI 0.01 to 0.76 (P = 0.049) and 0.20 Nm*s/BM*HT% 95% CI 0.10 to 0.30 (P

  17. Serum reference interval of ARCHITECT alpha-fetoprotein in healthy Chinese Han adults: Sub-analysis of a prospective multi-center study.

    Science.gov (United States)

    Yan, Cunling; Yang, Jia; Wei, Lianhua; Hu, Jian; Song, Jiaqi; Wang, Xiaoqin; Han, Ruilin; Huang, Ying; Zhang, Wei; Soh, Andrew; Beshiri, Agim; Fan, Zhuping; Zheng, Yijie; Chen, Wei

    2018-02-01

    Alpha-fetoprotein (AFP) has been widely used in clinical practice for decades. However, large-scale survey of serum reference interval for ARCHITECT AFP is still absent in Chinese population. This study aimed to measure serum AFP levels in healthy Chinese Han subjects, which is a sub-analysis of an ongoing prospective, cross-sectional, multi-center study (ClinicalTrials.gov Identifier: NCT03047603). This analysis included a total of 530 participants (41.43±12.14years of age on average, 48.49% males), enrolled from 5 regional centers. Serum AFP level was measured by ARCHITECT immunoassay. Statistical analysis was performed using SAS 9.4 and R software. AFP distribution did not show significant correlation with age or sex. The overall median and interquartile range of AFP was 2.87 (2.09, 3.83) ng/mL. AFP level did not show a trend of increasing with age. The new reference interval was 2.0-7.07ng/mL (LOQ- 97.5th percentiles). The reference interval for ARCHITECT AFP is updated with the data of adequate number of healthy Han adults. This new reference interval is more practical and applicable in Chinese adults. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  18. Patient-Related Determinants of the Administration of Continuous Palliative Sedation in Hospices and Palliative Care Units: A Prospective, Multicenter, Observational Study.

    Science.gov (United States)

    van Deijck, Rogier H P D; Hasselaar, Jeroen G J; Verhagen, Stans C A H H V M; Vissers, Kris C P; Koopmans, Raymond T C M

    2016-05-01

    Knowledge of determinants that are associated with the administration of continuous palliative sedation (CPS) helps physicians identify patients who are at risk of developing refractory symptoms, thereby enabling proactive care planning. This study aims to explore which patient-related factors at admission are associated with receiving CPS later in the terminal phase of life. A prospective multicenter observational study was performed in six Dutch hospices and three nursing home-based palliative care units. The association between patient-related variables at admission (age, gender, diagnosis, use of opioids or psycholeptics, number of medications, Karnofsky Performance Status scale score, Edmonton Symptom Assessment System distress score, and Glasgow Coma Scale score) and the administration of CPS at the end of life was analyzed. A total of 467 patients died during the study period, of whom 130 received CPS. In univariate analysis, statistically significant differences were noted between the sedated and nonsedated patients with respect to younger age (P = 0.009), malignancy as a diagnosis (P = 0.05), higher Karnofsky Performance Status score (P = 0.03), the use of opioids (P Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  19. Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study

    Directory of Open Access Journals (Sweden)

    Thibaut Pranal

    2018-01-01

    Full Text Available Rationale. Although soluble forms of the receptor for advanced glycation end products (RAGE have been recently proposed as biomarkers in multiple acute or chronic diseases, few studies evaluated the influence of usual clinical and biological parameters, or of patient characteristics and comorbidities, on circulating levels of soluble RAGE in the intensive care unit (ICU setting. Objectives. To determine, among clinical and biological parameters that are usually recorded upon ICU admission, which variables, if any, could be associated with plasma levels of soluble RAGE. Methods. Data for this ancillary study were prospectively obtained from adult patients with at least one ARDS risk factor upon ICU admission enrolled in a large multicenter observational study. At ICU admission, plasma levels of total soluble RAGE (sRAGE and endogenous secretory (esRAGE were measured by duplicate ELISA and baseline patient characteristics, comorbidities, and usual clinical and biological indices were recorded. After univariate analyses, significant variables were used in multivariate, multidimensional analyses. Measurements and Main Results. 294 patients were included in this ancillary study, among whom 62% were admitted for medical reasons, including septic shock (11%, coma (11%, and pneumonia (6%. Although some variables were associated with plasma levels of RAGE soluble forms in univariate analysis, multidimensional analyses showed no significant association between admission parameters and baseline plasma sRAGE or esRAGE. Conclusions. We found no obvious association between circulating levels of soluble RAGE and clinical and biological indices that are usually recorded upon ICU admission. This trial is registered with NCT02070536.

  20. A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

    Directory of Open Access Journals (Sweden)

    Bret T. Petersen

    2013-01-01

    Full Text Available Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientific, Natick, USA was assessed for palliation of extrahepatic malignant biliary obstruction. Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1 absence of stent occlusion within six months or until death, whichever occurred first and (2 technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events. Results. Technical success was achieved in 98% (57/58, with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achievedin 98% (54/55 of evaluable patients, with 1 reintervention due to stent obstruction after 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy. Conclusions. The WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.

  1. A comparison of laser-welded titanium and conventional cast frameworks supported by implants in the partially edentulous jaw: a 3-year prospective multicenter study.

    Science.gov (United States)

    Jemt, T; Henry, P; Lindén, B; Naert, I; Weber, H; Bergström, C

    2000-01-01

    The purpose of this prospective multicenter study was to evaluate and compare the clinical performance of laser-welded titanium fixed partial implant-supported prostheses with conventional cast frameworks. Forty-two partially edentulous patients were provided with Brånemark system implants and arranged into 2 groups. Group A was provided with a conventional cast framework with porcelain veneers in one side of the jaw and a laser-welded titanium framework with low-fusing porcelain on the other side. The patients in group B had an old implant prosthesis replaced by a titanium framework prosthesis. The patients were followed for 3 years after prosthesis placement. Clinical and radiographic data were collected and analyzed. Only one implant was lost, and all prostheses were still in function after 3 years. The 2 framework designs showed similar clinical performance with few clinical complications. Only one abutment screw (1%) and 9 porcelain tooth units (5%) fractured. Four prostheses experienced loose gold screws (6%). In group A, marginal bone loss was similar for both designs of prostheses, with a mean of 1.0 mm and 0.3 mm in the maxilla and mandible, respectively. No bone loss was observed on average in group B. No significant relationship (P > 0.05) was observed between marginal bone loss and placement of prosthesis margin or prosthesis design. The use of laser-welded titanium frameworks seems to present similar clinical performance to conventional cast frameworks in partial implant situations after 3 years.

  2. Multiple pregnancy, short cervix, part-time worker, steroid use, low educational level and male fetus are risk factors for preterm birth in Japan: a multicenter, prospective study.

    Science.gov (United States)

    Shiozaki, Arihiro; Yoneda, Satoshi; Nakabayashi, Masao; Takeda, Yoshiharu; Takeda, Satoru; Sugimura, Motoi; Yoshida, Koyo; Tajima, Atsushi; Manabe, Mami; Akagi, Kozo; Nakagawa, Shoko; Tada, Katsuhiko; Imafuku, Noriaki; Ogawa, Masanobu; Mizunoe, Tomoya; Kanayama, Naohiro; Itoh, Hiroaki; Minoura, Shigeki; Ogino, Mitsuharu; Saito, Shigeru

    2014-01-01

    To examine the relationship between preterm birth and socioeconomic factors, past history, cervical length, cervical interleukin-8, bacterial vaginosis, underlying diseases, use of medication, employment status, sex of the fetus and multiple pregnancy. In a multicenter, prospective, observational study, 1810 Japanese women registering their future delivery were enrolled at 8⁺⁰ to 12⁺⁶ weeks of gestation. Data on cervical length and delivery were obtained from 1365 pregnant women. Multivariate logistic regression analysis was performed. Short cervical length, steroid use, multiple pregnancy and male fetus were risk factors for preterm birth before 34 weeks of gestation. Multiple pregnancy, low educational level, short cervical length and part-timer were risk factors for preterm birth before 37 weeks of gestation. Multiple pregnancy and cervical shortening at 20-24 weeks of gestation was a stronger risk factor for preterm birth. Any pregnant woman being part-time employee or low educational level, having a male fetus and requiring steroid treatment should be watched for the development of preterm birth. © 2013 The Authors. Journal of Obstetrics and Gynaecology Research © 2013 Japan Society of Obstetrics and Gynecology.

  3. Derivation and Validation of a Biomarker-Based Clinical Algorithm to Rule Out Sepsis From Noninfectious Systemic Inflammatory Response Syndrome at Emergency Department Admission: A Multicenter Prospective Study.

    Science.gov (United States)

    Mearelli, Filippo; Fiotti, Nicola; Giansante, Carlo; Casarsa, Chiara; Orso, Daniele; De Helmersen, Marco; Altamura, Nicola; Ruscio, Maurizio; Castello, Luigi Mario; Colonetti, Efrem; Marino, Rossella; Barbati, Giulia; Bregnocchi, Andrea; Ronco, Claudio; Lupia, Enrico; Montrucchio, Giuseppe; Muiesan, Maria Lorenza; Di Somma, Salvatore; Avanzi, Gian Carlo; Biolo, Gianni

    2018-05-07

    To derive and validate a predictive algorithm integrating a nomogram-based prediction of the pretest probability of infection with a panel of serum biomarkers, which could robustly differentiate sepsis/septic shock from noninfectious systemic inflammatory response syndrome. Multicenter prospective study. At emergency department admission in five University hospitals. Nine-hundred forty-seven adults in inception cohort and 185 adults in validation cohort. None. A nomogram, including age, Sequential Organ Failure Assessment score, recent antimicrobial therapy, hyperthermia, leukocytosis, and high C-reactive protein values, was built in order to take data from 716 infected patients and 120 patients with noninfectious systemic inflammatory response syndrome to predict pretest probability of infection. Then, the best combination of procalcitonin, soluble phospholypase A2 group IIA, presepsin, soluble interleukin-2 receptor α, and soluble triggering receptor expressed on myeloid cell-1 was applied in order to categorize patients as "likely" or "unlikely" to be infected. The predictive algorithm required only procalcitonin backed up with soluble phospholypase A2 group IIA determined in 29% of the patients to rule out sepsis/septic shock with a negative predictive value of 93%. In a validation cohort of 158 patients, predictive algorithm reached 100% of negative predictive value requiring biomarker measurements in 18% of the population. We have developed and validated a high-performing, reproducible, and parsimonious algorithm to assist emergency department physicians in distinguishing sepsis/septic shock from noninfectious systemic inflammatory response syndrome.

  4. Pre-fracture nutritional status is predictive of functional status at discharge during the acute phase with hip fracture patients: A multicenter prospective cohort study.

    Science.gov (United States)

    Inoue, Tatsuro; Misu, Syogo; Tanaka, Toshiaki; Sakamoto, Hiroki; Iwata, Kentaro; Chuman, Yuki; Ono, Rei

    2017-10-01

    Malnutrition is common in patients with hip fractures, and elderly patients with hip fractures lose functional independence and often fail to recover previous functional status. The aim of this study was to determine whether pre-fracture nutritional status predicts functional status of patients with hip fracture at discharge from acute hospitals. In the present multicenter prospective cohort study, pre-fracture nutritional status was assessed using the Mini Nutritional Assessment Short-Form (MNA-SF). At discharge from acute hospitals, functional status was evaluated using a functional independent measurement instrument (FIM). Subsequently, multiple regression analyses were performed using FIM as the dependent variable and MNA-SF as the independent variable. Among the 204 patients analyzed in the present study, the mean length of hospital stay was 26.2 ± 12.6 days, and according to MNA-SF assessments, 51 (25.0%) patients were malnourished, 98 (48.0%) were at risk of malnutrition, and 55 (27.0%) were well-nourished before fracture. At discharge, FIM scores were higher in patients who were well-nourished than in those who were malnourished or were at risk of malnutrition (p fracture nutritional status was a significant independent predictor for functional status at discharge during the acute phase, warranting early assessment of nutritional status and early intervention for successful postoperative rehabilitation. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  5. Comparative Effectiveness of the Deqi Sensation and Non-Deqi by Moxibustion Stimulation: A Multicenter Prospective Cohort Study in the Treatment of Knee Osteoarthritis

    Directory of Open Access Journals (Sweden)

    Rixin Chen

    2013-01-01

    Full Text Available Substantial evidence has supported that moxibustion stimulates a unique phenomenon of Deqi, heat-sensitive moxibustion sensation. This study consisted of a multicenter, prospective cohort study with two parallel arms (A: heat-sensitive moxibustion sensation group; B: nonheat-sensitive moxibustion sensation group. All forms of moxibustion were applied unilaterally on the right leg with a triangle shape of three acupuncture points simultaneously (bilateral Xi Yan (EX-LE5 and He Ding (EX-LE2. After one month the primary outcome parameter GPCRND-KOA showed significant differences between groups: trial group 5.23 ± 2.65 (adjusted mean ± SE 95% CI [4.44~6.01] versus control group 7.43 ± 2.80 [6.59~8.26], P=0.0001. Significant differences were manifested in total M-JOA score during the follow-up period (P=0.0006. Mean knee circumference indicated significant difference between the groups (P=0.03; P=0.007. Overall, this evidence suggested that the effectiveness of the Deqi sensation group might be more superior than the non-Deqi sensation one in the treatment of KOA. This study was aimed at providing scientific evidence on the Deqi sensation of moxibustion and at showing that heat-sensitive moxibustion sensation is essential to achieve the preferable treatment effects of KOA.

  6. [Use of itopride in the symptoms of functional dyspepsia in Russia: results of a phase IV prospective open-label multicenter clinical trial].

    Science.gov (United States)

    Kas'ianenko, V I; Denisov, N L; Vasil'ev, Iu V

    2014-01-01

    To evaluate the efficacy and safety of itopride used to treat the symptoms of functional dyspepsia (FD) of the upper gastrointestinal tract. A prospective, open-label, multicenter trial using as a control the placebo response obtained in the previous investigations enrolled 96 adult patients. The diagnosis of FD corresponded to its Rome II criteria. Patients received itopride (Ganaton) oral tablets (50 mg) 3 times daily for 8 weeks. When included into the trial, the patients were orally given itopride (ganaton) tablets (50 mg) thrice daily before meals for 8 weeks. The patients' status was evaluated during (at weeks 4 and 8) and after (at week 12) treatment. Treatment response was assessed using the Global Patient Assessment (GPA) and the Leeds Dyspepsia Questionnaire (LDQ). To evaluate the safety of itopride use, the investigators studied the frequency of adverse events and carried out laboratory tests (renal and liver function tests) and electrocardiography (ECG). The GPA showed that 53.76, 85.71, and 82.22% of the patients achieved a therapeutic effect of itopride at weeks 4, 8, and 12, respectively. The proportion of the patients who achieved the therapeutic effect (86%) at week 8 was higher than the historical placebo controls in the previous studies--45% (86% vs 45%; X2 = 68.868, df = 3; p Itopride is an effective and well-tolerated drug in the treatment of functional dyspepsia in the Russian patients.

  7. Predictive validity of granulation tissue color measured by digital image analysis for deep pressure ulcer healing: a multicenter prospective cohort study.

    Science.gov (United States)

    Iizaka, Shinji; Kaitani, Toshiko; Sugama, Junko; Nakagami, Gojiro; Naito, Ayumi; Koyanagi, Hiroe; Konya, Chizuko; Sanada, Hiromi

    2013-01-01

    This multicenter prospective cohort study examined the predictive validity of granulation tissue color evaluated by digital image analysis for deep pressure ulcer healing. Ninety-one patients with deep pressure ulcers were followed for 3 weeks. From a wound photograph taken at baseline, an image representing the granulation red index (GRI) was processed in which a redder color represented higher values. We calculated the average GRI over granulation tissue and the proportion of pixels exceeding the threshold intensity of 80 for the granulation tissue surface (%GRI80) and wound surface (%wound red index 80). In the receiver operating characteristics curve analysis, most GRI parameters had adequate discriminative values for both improvement of the DESIGN-R total score and wound closure. Ulcers were categorized by the obtained cutoff points of the average GRI (≤80, >80), %GRI80 (≤55, >55-80, >80%), and %wound red index 80 (≤25, >25-50, >50%). In the linear mixed model, higher classes for all GRI parameters showed significantly greater relative improvement in overall wound severity during the 3 weeks after adjustment for patient characteristics and wound locations. Assessment of granulation tissue color by digital image analysis will be useful as an objective monitoring tool for granulation tissue quality or surrogate outcomes of pressure ulcer healing. © 2012 by the Wound Healing Society.

  8. The impact of social engagement on health-related quality of life and depressive symptoms in old age - evidence from a multicenter prospective cohort study in Germany.

    Science.gov (United States)

    Hajek, André; Brettschneider, Christian; Mallon, Tina; Ernst, Annette; Mamone, Silke; Wiese, Birgitt; Weyerer, Siegfried; Werle, Jochen; Pentzek, Michael; Fuchs, Angela; Stein, Janine; Luck, Tobias; Bickel, Horst; Weeg, Dagmar; Wagner, Michael; Heser, Kathrin; Maier, Wolfgang; Scherer, Martin; Riedel-Heller, Steffi G; König, Hans-Helmut

    2017-07-14

    Thus far, only a few longitudinal studies investigated the impact of social engagement on health-related quality of life (HRQoL) and depressive symptoms in old age. Therefore, we aimed to examine the impact of social engagement on HRQoL and depressive symptoms in late life. Individuals aged 75 years and over at baseline were interviewed every 1.5 years in a multicenter prospective cohort study in Germany. While HRQoL was quantified by using the Visual Analogue Scale (EQ VAS) of the EQ-5D instrument, depressive symptoms was assessed by using the Geriatric Depression Scale (GDS). Individuals reported the frequency ("never" to "every day") of social engagement (e.g., engagement in the church, as a volunteer, in a party, or in a club) in the last four weeks. Fixed effects regressions were used to estimate the effect of social engagement on the outcome variables. After adjusting for age, marital status, functional status and chronic diseases, fixed effects regressions revealed that the onset of social engagement markedly increased HRQoL and considerably decreased depressive symptoms in the total sample and in women, but not men. Our findings corroborate the relevance of social engagement for HRQoL and depressive symptoms in old age. Encouraging the individuals to start, maintain and expand social engagement in late life might help to maintain and improve HRQoL and decrease depressive symptoms.

  9. The Progetto Nazionale Emorragia Digestiva (PNED) system vs. the Rockall score as mortality predictors in patients with nonvariceal upper gastrointestinal bleeding: A multicenter prospective study.

    Science.gov (United States)

    Contreras-Omaña, R; Alfaro-Reynoso, J A; Cruz-Chávez, C E; Velarde-Ruiz Velasco, A; Flores-Ramírez, D I; Romero-Hernández, I; Donato-Olguín, I; García-Samper, X; Bautista-Santos, A; Reyes-Bastidas, M; Millán-Marín, E

    The predictive scale for mortality risk in patients with nonvariceal upper gastrointestinal bleeding (NVUGIB) proposed by Italy's PNED (Progetto Nazionale Emorragia Digestiva) group has not been validated in Latin America since its original publication. To compare the PNED system and the Rockall score as mortality predictors in patients hospitalized for NVUGIB. A multicenter, prospective, cross-sectional, analytic study was conducted that recruited patients diagnosed with nonvariceal upper gastrointestinal bleeding within the time frame of 2011 to 2015. Six Mexican hospital centers participated in the study. The Rockall and PNED system scores were calculated, classifying the patients as having mild, moderate, or severe disease. The association between mortality and risk was determined through the chi-square test and relative risk (RR) calculation. Statistical significance was set at a Pbleeding. According to the Rockall score, 46 patients had severe disease (23.2%), 5 of whom died, with a RR of 5.5 (CI 1.35-22.02, P=.006). In relation to the PNED, only 8 patients had severe disease (4%), 5 of whom died, with a RR of 38.7 (CI 11.4-137.3, P=.001). The PNED system was more selective for classifying a case as severe, but it had a greater predictive capacity for mortality, compared with the Rockall score. Copyright © 2016 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

  10. Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation.

    Science.gov (United States)

    Takahashi, Kota; Saito, Kazuhide; Takahara, Shiro; Fuchinoue, Shohei; Yagisawa, Takashi; Aikawa, Atsushi; Watarai, Yoshihiko; Yoshimura, Norio; Tanabe, Kazunari; Morozumi, Kunio; Shimazu, Motohide

    2017-08-01

    Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m 2 at day -14 and day -1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

  11. Prognosis of patients excluded by the definition of septic shock based on their lactate levels after initial fluid resuscitation: a prospective multi-center observational study.

    Science.gov (United States)

    Ko, Byuk Sung; Kim, Kyuseok; Choi, Sung-Hyuk; Kang, Gu Hyun; Shin, Tae Gun; Jo, You Hwan; Ryoo, Seung Mok; Beom, Jin Ho; Kwon, Woon Yong; Han, Kap Su; Choi, Han Sung; Chung, Sung Phil; Suh, Gil Joon; Lim, Tae Ho; Kim, Won Young

    2018-02-24

    Septic shock can be defined both by the presence of hyperlactatemia and need of vasopressors. Lactate levels should be measured after volume resuscitation (as per the Sepsis-3 definition). However, currently, no studies have evaluated patients who have been excluded by the new criteria for septic shock. The aim of this study was to determine the clinical characteristics and prognosis of these patients, based on their lactate levels after initial fluid resuscitation. This observational study was performed using a prospective, multi-center registry of septic shock, with the participation of 10 hospitals in the Korean Shock Society, between October 2015 and February 2017. We compared the 28-day mortality between patients who were excluded from the new definition (defined as lactate level definition of septic shock. These patients, in whom perfusion was restored, demonstrated significantly lower age, platelet count, and initial and subsequent lactate levels (all p < 0.01). Similarly, significantly lower 28-day mortality was observed in these patients than in those who had not been excluded (8.2% vs 25.5%, p = 0.02). In-hospital mortality and the maximum SOFA score were also significantly lower in the excluded patients group (p = 0.03, both). It seems reasonable for septic shock to be defined by the lactate levels after volume resuscitation. However, owing to the small number of patients in whom lactate levels were improved, further study is warranted.

  12. Baseline data from a multicenter, 5-year, prospective cohort study of Japanese age-related macular degeneration: an AMD2000 report.

    Science.gov (United States)

    Tsujikawa, Akitaka; Akagi-Kurashige, Yumiko; Yuzawa, Mitsuko; Ishibashi, Tatsuro; Nakanishi, Hideo; Nakatani, Eiji; Teramukai, Satoshi; Fukushima, Masanori; Yoshimura, Nagahisa

    2018-03-01

    To report research participants' baseline characteristics in the AMD2000 study, a prospective, multicenter, 5-year, observational cohort study of Japanese age-related macular degeneration (AMD). The characteristics were determined using multimodal imaging. Patients with AMD were recruited at 18 clinical sites in Japan between April 2006 and March 2009. Each patient underwent a complete ophthalmic examination, including measurement of best-corrected visual acuity (Landolt chart), indirect ophthalmoscopy, slit-lamp biomicroscopy with a contact lens, optical coherence tomography imaging, fundus photography, and fluorescein and indocyanine green angiography. Four hundred sixty participants (326 men [70.9%]) were included in the study. At enrollment, 131 eyes (28.5%) had hard drusen and 125 eyes (27.2%) had soft drusen in the macular area. A total of 455 eyes (98.9%) were diagnosed as having wet AMD, and 5 eyes (1.1%), as having dry AMD. Of the 455 eyes with wet AMD, 209 eyes (45.4%) had typical AMD, 228 eyes (49.6%) had polypoidal choroidal vasculopathy (PCV), and 18 eyes (3.9%) had retinal angiomatous proliferation. The size of choroidal neovascularization (CNV) was significantly smaller with indocyanine green angiography than with fluorescein angiography (P macular edema, older age, scar, extrafoveal macular edema, subfoveal CNV, large branching vascular network, and hard exudates. Japanese patients with AMD are predominantly male, lack drusen, and have a high rate of PCV.

  13. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial.

    Science.gov (United States)

    Levkovitz, Yechiel; Isserles, Moshe; Padberg, Frank; Lisanby, Sarah H; Bystritsky, Alexander; Xia, Guohua; Tendler, Aron; Daskalakis, Zafiris J; Winston, Jaron L; Dannon, Pinhas; Hafez, Hisham M; Reti, Irving M; Morales, Oscar G; Schlaepfer, Thomas E; Hollander, Eric; Berman, Joshua A; Husain, Mustafa M; Sofer, Uzi; Stein, Ahava; Adler, Shmulik; Deutsch, Lisa; Deutsch, Frederic; Roth, Yiftach; George, Mark S; Zangen, Abraham

    2015-02-01

    Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22-68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p=0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p=0.013; remission: 32.6 vs. 14.6%, p=0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. © 2015 World Psychiatric Association.

  14. Salivary pathogen and serum antibody to assess the progression of chronic periodontitis: a 24-mo prospective multicenter cohort study.

    Science.gov (United States)

    Morozumi, T; Nakagawa, T; Nomura, Y; Sugaya, T; Kawanami, M; Suzuki, F; Takahashi, K; Abe, Y; Sato, S; Makino-Oi, A; Saito, A; Takano, S; Minabe, M; Nakayama, Y; Ogata, Y; Kobayashi, H; Izumi, Y; Sugano, N; Ito, K; Sekino, S; Numabe, Y; Fukaya, C; Yoshinari, N; Fukuda, M; Noguchi, T; Kono, T; Umeda, M; Fujise, O; Nishimura, F; Yoshimura, A; Hara, Y; Nakamura, T; Noguchi, K; Kakuta, E; Hanada, N; Takashiba, S; Yoshie, H

    2016-12-01

    A diagnosis of periodontitis progression is presently limited to clinical parameters such as attachment loss and radiographic imaging. The aim of this multicenter study was to monitor disease progression in patients with chronic periodontitis during a 24-mo follow-up program and to evaluate the amount of bacteria in saliva and corresponding IgG titers in serum for determining the diagnostic usefulness of each in indicating disease progression and stability. A total of 163 patients with chronic periodontitis who received trimonthly follow-up care were observed for 24 mo. The clinical parameters and salivary content of Porphyromonas gingivalis, Prevotella intermedia and Aggregatibacter actinomycetemcomitans were assessed using the modified Invader PLUS assay, and the corresponding serum IgG titers were measured using ELISA. The changes through 24 mo were analyzed using cut-off values calculated for each factor. One-way ANOVA or Fisher's exact test was used to perform between-group comparison for the data collected. Diagnostic values were calculated using Fisher's exact test. Of the 124 individuals who completed the 24-mo monitoring phase, 62 exhibited periodontitis progression, whereas 62 demonstrated stable disease. Seven patients withdrew because of acute periodontal abscess. The ratio of P. gingivalis to total bacteria and the combination of P. gingivalis counts and IgG titers against P. gingivalis were significantly related to the progression of periodontitis. The combination of P. gingivalis ratio and P. gingivalis IgG titers was significantly associated with the progression of periodontitis (p = 0.001, sensitivity = 0.339, specificity = 0.790). It is suggested that the combination of P. gingivalis ratio in saliva and serum IgG titers against P. gingivalis may be associated with the progression of periodontitis. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  15. Renoprotective effects of topiroxostat for hyperuremic patients with overt diabetic nephropathy study (ETUDE Study): A prospective, randomized, multicenter clinical trial.

    Science.gov (United States)

    Mizukoshi, Toshihiro; Kato, Sawako; Ando, Masahiko; Sobajima, Hiroshi; Ohashi, Norimi; Naruse, Tomohiko; Saka, Yosuke; Shimizu, Hideaki; Nagata, Takanobu; Maruyama, Shoichi

    2017-10-09

    We aimed to evaluate the anti-albuminuric effects of topiroxostat in Japanese hyperuricemic patients with diabetic nephropathy. In this 24-week, multicenter, open-label, randomized (1:1) trial, we assigned hyperuricemic patients with diabetic nephropathy (estimated glomerular filtration rate ≥ 20 mL/min/1.73m 2 ) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) <3.5 g/g Cr) to either high dose (160 mg daily) or low dose (40 mg daily) topiroxostat. The primary endpoint was the change in albuminuria indicated by urine albumin-to-creatinine ratio (UACR) from the baseline at the final time point. A total of 80 patients underwent randomization. The changes in UACR after 24 weeks of treatment (or at the final time point if patients failed to reach 24 weeks) relative to the baseline were -122 mg/gCr (95% CI: -5.1 to -240.1, P = 0.041) in patients treated with high dose, while treatment with low dose topiroxostat could not show significant reduction (P = 0.067). In the linear mixed model including baseline albuminuria, eGFR, age, and sex as covariates, the decreases in UACR were still significant from baseline to 12 weeks by 228.7 ± 83.2 mg/gCr (P = 0.0075) in the high dose group. The adverse-event profile during this study was not different between the groups. Topiroxostat 160 mg daily reduced albuminuria in patients with diabetic nephropathy. (Funded by Sanwa Kagaku Kenkyusho; Trial registration, UMIN000015403). This article is protected by copyright. All rights reserved.

  16. Hartmann's Procedure or Primary Anastomosis for Generalized Peritonitis due to Perforated Diverticulitis: A Prospective Multicenter Randomized Trial (DIVERTI).

    Science.gov (United States)

    Bridoux, Valerie; Regimbeau, Jean Marc; Ouaissi, Mehdi; Mathonnet, Muriel; Mauvais, Francois; Houivet, Estelle; Schwarz, Lilian; Mege, Diane; Sielezneff, Igor; Sabbagh, Charles; Tuech, Jean-Jacques

    2017-12-01

    About 25% of patients with acute diverticulitis require emergency intervention. Currently, most patients with diverticular peritonitis undergo a Hartmann's procedure. Our objective was to assess whether primary anastomosis (PA) with a diverting stoma results in lower mortality rates than Hartmann's procedure (HP) in patients with diverticular peritonitis. We conducted a multicenter randomized controlled trial conducted between June 2008 and May 2012: the DIVERTI (Primary vs Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis) trial. Follow-up duration was up to 18 months. A random sample of 102 eligible participants with purulent or fecal diverticular peritonitis from tertiary care referral centers and associated centers in France were equally randomized to either a PA arm or to an HP arm. Data were analyzed on an intention-to-treat basis. The primary end point was mortality rate at 18 months. Secondary outcomes were postoperative complications, operative time, length of hospital stay, rate of definitive stoma, and morbidity. All 102 patients enrolled were comparable for age (p = 0.4453), sex (p = 0.2347), Hinchey stage III vs IV (p = 0.2347), and Mannheim Peritonitis Index (p = 0.0606). Overall mortality did not differ significantly between HP (7.7%) and PA (4%) (p = 0.4233). Morbidity for both resection and stoma reversal operations were comparable (39% in the HP arm vs 44% in the PA arm; p = 0.4233). At 18 months, 96% of PA patients and 65% of HP patients had a stoma reversal (p = 0.0001). Although mortality was similar in both arms, the rate of stoma reversal was significantly higher in the PA arm. This trial provides additional evidence in favor of PA with diverting ileostomy over HP in patients with diverticular peritonitis. ClinicalTrials.gov Identifier: NCT 00692393. Copyright © 2017. Published by Elsevier Inc.

  17. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study.

    Science.gov (United States)

    Berlucchi, Marco; Castelnuovo, Paolo; Vincenzi, Andrea; Morra, Bruno; Pasquini, Ernesto

    2009-06-01

    Nasal packings can aid in control of postoperative bleeding and healing following functional endoscopic sinus surgery (FESS), but traditional non-resorbable stents have several inherent drawbacks. We performed a randomized, controlled, multicenter clinical trial to assess efficacy of resorbable nasal packing in patients undergoing FESS for chronic rhinosinusitis. A total of 66 patients for 88 nasal cavities were randomized to receive either hyaluronan resorbable packing (MeroGel) or standard non-resorbable nasal dressing after FESS. All underwent preoperative rhinoscopy, CT of sinuses, and, after surgery, were reassessed by rhinoscopy at 2, 4, and 12 weeks in blinded fashion. A total of 44 nasal cavities (MeroGel-group) received resorbable packing, whereas the remaining 44 were packed with non-resorbable nasal dressing. At follow-up endoscopic visit, the presence of nasal synechia was evaluated as primary outcome. Moreover, the tolerability and surgical handling properties of MeroGel and its comfort were assessed by surgeons and patients. Preoperative severity of rhinosinusitis was similar in both groups. No significant adverse events were observed in all patients. Follow-up endoscopy showed a lower proportion of nasal adhesions in MeroGel-group at both 4 (P = 0.041) and 12 weeks (P appearance of nasal mucosa of nasal cavities after FESS was observed in the MeroGel-group. Tolerability and surgical handling properties of MeroGel were positively rated by clinicians and the overall patient judged comfort of MeroGel was favorable. In conclusion, MeroGel can be considered a valid alternative to standard non-resorbable nasal dressings. It is safe, well-accepted, well-tolerated, and has significant advantage of being resorbable. Moreover, it may favor improved healing in patients undergoing FESS and reduce formation of adhesions.

  18. Three-year colonoscopy surveillance after polypectomy in Korea: a Korean Association for the Study of Intestinal Diseases (KASID multicenter prospective study

    Directory of Open Access Journals (Sweden)

    Won Seok Choi

    2018-01-01

    Full Text Available Background/Aims: Colonoscopic surveillance is currently recommended after polypectomy owing to the risk of newly developed colonic neoplasia. However, few studies have investigated colonoscopy surveillance in Asia. This multicenter and prospective study was undertaken to assess the incidence of advanced adenoma based on baseline adenoma findings at 3 years after colonoscopic polypectomy. Methods: A total of 1,323 patients undergoing colonoscopic polypectomy were prospectively assigned to 3-year colonoscopy surveillance at 11 tertiary endoscopic centers. Relative risks for advanced adenoma after 3 years were calculated according to baseline adenoma characteristics. Results: Among 1,323 patients enrolled, 387 patients (29.3% were followed up, and the mean follow-up interval was 31.0±9.8 months. The percentage of patients with advanced adenoma on baseline colonoscopy was higher in the surveillance group compared to the non-surveillance group (34.4% vs. 25.7%. Advanced adenoma recurrence was observed in 17 patients (4.4% at follow-up. The risk of advanced adenoma recurrence was 2 times greater in patients with baseline advanced adenoma than in those with baseline non-advanced adenoma, though the difference was not statistically significant (6.8% [9/133] vs. 3.1% [8/254], P=0.09. Advanced adenoma recurrence was observed only in males and in subjects aged ≥50 years. In contrast, adenoma recurrence was observed in 187 patients (48.3% at follow-up. Male sex, older age (≥50 years, and multiple adenomas (≥3 at baseline were independent risk factors for adenoma recurrence. Conclusions: A colonoscopy surveillance interval of 3 years in patients with baseline advanced adenoma can be considered appropriate.

  19. Safety and effectiveness of the Phoenix Atherectomy System in lower extremity arteries: Early and midterm outcomes from the prospective multicenter EASE study.

    Science.gov (United States)

    Davis, Thomas; Ramaiah, Venkatesh; Niazi, Khusrow; Martin Gissler, Hans; Crabtree, Tami

    2017-12-01

    Objectives To evaluate the novel Phoenix Atherectomy System as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions. Methods This prospective, multicenter, nonrandomized investigational device exemption trial was conducted across 16 US and German centers between August 2010 and April 2013. Intention-to-treat enrollment was 128 patients (mean age: 71.8 years, 59% male) with 149 lesions (mean length: 34 mm, mean diameter stenosis: 89.5%), and the primary analysis per-protocol population consisted of 105 patients with 123 lesions. The primary efficacy endpoint, technical success, was the achievement of acute debulking with a post-atherectomy residual diameter stenosis ≤50% (before adjunctive therapy). The primary safety endpoint was the major adverse event (MAE) rate through 30 days. Results For the primary analysis per-protocol population, the rate of lesion technical success was 95.1% (117/123), with the lower limit of the 95% CI 90.6%, meeting the prospectively established target performance goal of ≥86%. After post-atherectomy adjunctive therapy, residual stenosis was ≤30% for 99.2% (122/123) of lesions (mean final diameter stenosis 10.5%). Improvement of ≥1 Rutherford class occurred for 74.5% of patients through 30 days and for 80% through six months. MAEs were experienced by 5.7% (6/105) of patients through 30 days (with the upper limit of the 95% CI 11.0%, meeting the target performance goal of Atherectomy System is safe and effective for the debulking of lower-extremity arterial lesions. ClinicalTrials.gov identifier NCT01541774.

  20. A prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes

    Directory of Open Access Journals (Sweden)

    Lipsky Benjamin A

    2012-09-01

    Full Text Available Abstract Background Complicated skin and soft tissue infections (cSSTIs occur frequently, but limited data do not allow any consensus on an optimal treatment strategy. We designed this prospective, multicenter, observational study to to explore the current epidemiology, treatment, and resulting clinical outcomes of cSSTIs to help develop strategies to potentially improve outcomes. Methods From June 2008 to December 2009 we enrolled a pre-specified number of adults treated in 56 U.S. hospitals with intravenous antibiotic(s for any of the following cSSTIs: diabetic foot infection (DFI; surgical site infection (SSI; deep soft tissue abscess (DSTA; or, cellulitis. Investigators treated all patients per their usual practice during the study and collected data on a standardized form. Results We enrolled 1,033 patients (DFI 27%; SSI 32%; DSTA 14%; cellulitis 27%; mean age 54 years; 54% male, of which 74% had healthcare-associated risk factors. At presentation, 89% of patients received initial empiric therapy with intravenous antibiotics; ~20% of these patients had this empiric regimen changed or discontinued based on culture and sensitivity results. Vancomycin was the most frequently used initial intravenous antibiotic, ordered in 61% of cases. During their stay 44% of patients underwent a surgical procedure related to the study infection, usually incision and drainage or debridement. The mean length of stay was 7.1 days, ranging from 5.8 (DSTA to 8.1 (SSI. Conclusion Our findings from this large prospective observational study that characterized patients with cSSTIs from diverse US inpatient populations provide useful information on the current epidemiology, clinical management practices and outcomes of this common infection.

  1. The prognostic significance of atrial fibrillation in heart failure with preserved ejection function: insights from KaRen, a prospective and multicenter study.

    Science.gov (United States)

    Bosseau, Christian; Donal, Erwan; Lund, Lars H; Oger, Emmanuel; Hage, Camilla; Mulak, Geneviève; Daubert, Jean-Claude; Linde, Cecilia

    2017-06-01

    The prognostic value of atrial fibrillation (AF) in heart failure with preserved ejection fraction (HFPEF) remains controversial. We sought to study the prognostic value of AF in a prospective cohort and to characterize the HFPEF patients with AF. KaRen was a prospective, multicenter, international, observational study intended to characterize HFPEF; 538 patients presenting with an acute decompensated cardiac failure and a left ventricular EF > 45% were included. EKG and echocardiogram performed 4-8 week following the index hospitalization were analyzed in core centers. Clinical and echocardiographic characteristics of patients in sinus rhythm vs. with documented AF at enrolment (decompensated HF), upon their 4-8-week visit (in presumed stable clinical condition) and according to patients' cardiac history, were compared. The primary study endpoint was death from any cause or first hospitalization for decompensated heart failure (HF). A total of 413 patients (32% in AF) were analyzed, with a mean follow-up period of 28 months. The patients were primarily elderly individuals (mean age: 76.2 years), with a slight female predominance and a high prevalence of non-cardiovascular comorbidities. The baseline echocardiographic characteristics and the natriuretic peptide levels were indicative of a more severe heart condition among the patients with AF. However, the patients with AF exhibited a similar survival-free interval compared with the patients in sinus rhythm. In this elderly HFPEF population with a high prevalence of non-cardiovascular comorbidities, the presence of AF was not associated with a worse prognosis despite impaired clinical and echocardiographic features.ClinicalTrials.gov: NCT00774709.

  2. Health-related quality of life is related to cytokine levels at 12 months in patients with chronic heart failure

    DEFF Research Database (Denmark)

    Mommersteeg, Paula M C; Kupper, Nina; Schoormans, Dounya

    2010-01-01

    for the MLHFQ, the SF-36 mental component summary (MCS) and the physical component summary (PCS), controlling for age, sex, BMI, smoking, co morbidity, NYHA-class and 6min walk test. Baseline MLHFQ was associated with increased levels of baseline sTNFR2, and 12-month sTNFR1 12month sTNFR2. Baseline MCS...

  3. Identification of Infants at Risk for Autism Spectrum Disorder and Developmental Language Delay Prior to 12 Months

    Science.gov (United States)

    Samango-Sprouse, Carole A.; Stapleton, Emily J.; Aliabadi, Farhad; Graw, Robert; Vickers, Rebecca; Haskell, Kathryn; Sadeghin, Teresa; Jameson, Robert; Parmele, Charles L.; Gropman, Andrea L.

    2015-01-01

    Studies have shown an increased head circumference and the absence of the head tilt reflex as possible risk factors for autism spectrum disorder, allowing for early detection at 12 months in typically developing population of infants. Our aim was to develop a screening tool to identify infants prior to 12 months at risk for autism spectrum…

  4. Dry Eye Disease following Refractive Surgery: A 12-Month Follow-Up of SMILE versus FS-LASIK in High Myopia

    Directory of Open Access Journals (Sweden)

    Bingjie Wang

    2015-01-01

    Full Text Available Purpose. To compare dry eye disease following SMILE versus FS-LASIK. Design. Prospective, nonrandomised, observational study. Patients. 90 patients undergoing refractive surgery for myopia were included. 47 eyes underwent SMILE and 43 eyes underwent FS-LASIK. Methods. Evaluation of dry eye disease was conducted preoperatively and at 1, 3, 6, and 12 months postoperatively, using the Salisbury Eye Evaluation Questionnaire (SEEQ and TBUT. Results. TBUT reduced following SMILE at 1 and 3 months (p<0.001 and at 1, 3, and 6 months following FS-LASIK (p<0.001. TBUT was greater following SMILE than FS-LASIK at 3, 6, and 12 months (p<0.001, p<0.001, and p=0.009, resp.. SEEQ scores increased (greater symptoms following SMILE at 1 month (p<0.001 and 3 months (p=0.003 and at 1, 3, and 6 months following FS-LASIK (p<0.001. SMILE produced lower SEEQ scores (fewer symptoms than FS-LASIK at 1, 3, and 6 months (p<0.001. Conclusion. SMILE produces less dry eye disease than FS-LASIK at 6 months postoperatively but demonstrates similar degrees of dry eye disease at 12 months.

  5. Factors influencing oral hygiene behaviour and gingival outcomes 3 and 12 months after initial periodontal treatment: an exploratory test of an extended Theory of Reasoned Action.

    Science.gov (United States)

    Jönsson, Birgitta; Baker, Sarah R; Lindberg, Per; Oscarson, Nils; Ohrn, Kerstin

    2012-02-01

    The aim was to empirically test the extended Theory of Reasoned Action (TRA) and the prospective direct and indirect role of attitudes, beliefs, subjective norms, self-efficacy, and a cognitive behavioural intervention in adult's oral hygiene behaviour and gingival outcomes at 3- and 12-month follow-up. Data were derived from an RCT evaluating the effectiveness of oral hygiene educational programs integrated in non-surgical periodontal treatment (n = 113). Before baseline examination, participants completed a self-report questionnaire. Structural equation modelling using maximum likelihood estimation with bootstrapping was used to test the direct and indirect (mediated) pathways within the extended TRA model. The extended TRA model explained a large amount of variance in gingival outcome scores at 12 months (56%). A higher level of self-efficacy at baseline was associated with higher frequencies of oral hygiene behaviour at 3 months. Being female was linked to more normative beliefs that, in turn, related to greater behavioural beliefs and self-efficacy. Gender was also related to behavioural beliefs, attitudes and subjective norms. Both frequency of oral hygiene behaviour at 3 months and the cognitive behavioural intervention predicted gingival outcome at 12 months. The model demonstrated that self-efficacy, gender and a cognitive behavioural intervention were important predictors of oral hygiene behavioural change. © 2011 John Wiley & Sons A/S.

  6. Prediction of motivational impairment: 12-month follow-up of the randomized-controlled trial on extended early intervention for first-episode psychosis.

    Science.gov (United States)

    Chang, W C; Kwong, V W Y; Chan, G H K; Jim, O T T; Lau, E S K; Hui, C L M; Chan, S K W; Lee, E H M; Chen, E Y H

    2017-03-01

    Amotivation is prevalent in first-episode psychosis (FEP) patients and is a major determinant of functional outcome. Prediction of amotivation in the early stage of psychosis, however, is under-studied. We aimed to prospectively examine predictors of amotivation in FEP patients in a randomized-controlled trial comparing a 1-year extension of early intervention (Extended EI, 3-year EI) with step-down psychiatric care (SC, 2-year EI). One hundred sixty Chinese patents were recruited from a specialized EI program for FEP in Hong Kong after they have completed this 2-year EI service, randomly allocated to Extended EI or SC, and followed up for 12 months. Assessments on premorbid adjustment, onset profiles, baseline symptom severity and treatment characteristics were conducted. Data analysis was based on 156 subjects who completed follow-up assessments. Amotivation at 12-month follow-up was associated with premorbid adjustment, allocated treatment condition, and levels of positive symptoms, disorganization, amotivation, diminished expression (DE) and depression at study intake. Hierarchical multiple regression analysis revealed that Extended EI and lower levels of DE independently predicted better outcome on 12-month amotivation. Our findings indicate a potentially critical therapeutic role of an extended specialized EI on alleviating motivational impairment in FEP patients. The longer-term effect of Extended EI on amotivation merits further investigation. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  7. The influence of maternal optimality and infant temperament on parenting stress at 12 months among mothers with substance abuse and psychiatric problems.

    Science.gov (United States)

    Siqveland, Torill S; Olafsen, Kåre S; Moe, Vibeke

    2013-10-01

    The present prospective longitudinal study aimed to investigate the long-term impact of maternal optimality assessed during pregnancy on parenting stress at infant age 12 months. In this study the concept of optimality was utilized to investigate maternal variations regarding resources during pregnancy in relation to later parenting stress, among three different groups of mothers that were recruited from substance abuse treatment, psychiatric outpatient treatment and well-baby clinics respectively. The influence of infant temperament on parenting stress was also examined. All mothers were interviewed during pregnancy. At 12 months, infant temperament (Colorado Childhood Temperament Inventory; Rowe & Plomin, 1977) and stress in the parent and child domain (Parenting Stress Index; Abidin, 1955) were assessed. Results demonstrated higher levels of parenting stress among mothers in the clinical groups, compared to the non-clinical group. Furthermore, it was the maternal psychiatric optimality index in combination with child temperament characteristics (child emotionality) that contributed uniquely to stress in the parent domain, while stress in the child domain was significantly associated only with child temperament characteristics (both child emotionality and soothability). The association between maternal psychiatric optimality assessed in pregnancy, infant temperament and parenting stress when the infants were 12 months old, points to the importance of simultaneously addressing the mothers' own psychological distress, and to support positive mother-infant interactions. Each woman's individual optimality profile may be used to display needs of follow-up in order to prevent enduring effects of non-optimality on parenting stress. © 2013 The Scandinavian Psychological Associations.

  8. Risk factor assessment and counselling for 12 months reduces metabolic and cardiovascular risk in overweight or obese patients with schizophrenia spectrum disorders: The CRESSOB study.

    Science.gov (United States)

    Gutiérrez-Rojas, Luis; Pulido, Susana; Azanza, Jose R; Bernardo, Miguel; Rojo, Luis; Mesa, Francisco J; Martínez-Ortega, Jose M

    2016-01-01

    Metabolic syndrome (MS) and cardiovascular risk factors (CRF) have been associated with patients with schizophrenia. The main objective is to assess the evolution of CRF and prevalence of MS for 12 months in a cohort of overweight patients diagnosed with schizophrenia schizophreniform disorder or schizoaffective disorder in which the recommendations for the assessment and control of metabolic and cardiovascular risk were applied. The Control of Metabolic and Cardiovascular Risk in Patients with Schizophrenia and Overweight (CRESSOB) study is a 12-month, observational, prospective, open-label, multicentre, naturalistic study including 109 community mental health clinics of Spain. The study included a total of 403 patients, of whom we could collect all variables related to CRF and MS in 366 patients. Of these 366 patients, 286 completed the follow-up, (baseline, months 3, 6 and 12) where they underwent a complete physical examination and a blood test (glucose, cholesterol and triglycerides), they were asked about their health-related habits (smoking, diet and exercise) and they were given a series of recommendations to prevent cardiovascular risk and MS. A total of 403 patients were included, 63% men, mean age (mean; (SD)) 40.5 (10.5) years. After 12 months, the study showed statistically significant decrease in weight (prisk of heart disease at 10 years (p=0.0353). Overweight patients with schizophrenia who receive appropriate medical care, including CRF monitoring and control of health-related habits experience improvements with regard to most CRFs.

  9. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer

    International Nuclear Information System (INIS)

    Ishiguro, Megumi; Mori, Masaki; Kakeji, Yoshihiro; Kanazawa, Akiyoshi; Kobayashi, Michiya; Okajima, Masazumi; Hyodo, Ichinosuke; Miyakoda, Keiko; Sugihara, Kenichi; Kotake, Kenjiro; Nishimura, Genichi; Tomita, Naohiro; Ichikawa, Wataru; Takahashi, Keiichi; Watanabe, Toshiaki; Furuhata, Tomohisa; Kondo, Ken

    2013-01-01

    Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy. Several oral fluorouracil (5-FU) derivatives with different properties are available in Japan, but which drug is the most appropriate for each patient has not been established. Although efficacy prediction of 5-FU derivatives using expression of 5-FU activation/metabolism enzymes in tumors has been studied, it has not been clinically applied. The B-CAST study is a multicenter, prospective cohort study aimed to identify the patients who benefit from adjuvant chemotherapy with each 5-FU regimen, through evaluating the relationship between tumor biomarker expression and treatment outcome. The frozen tumor specimens of patients with stage III colon cancer who receives postoperative adjuvant chemotherapy are examined. Protein expression of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), epidermal growth factor receptor (EGFR), and vascular endothelial growth factor (VEGF) are evaluated using enzyme-linked immunosorbent assay (ELISA). mRNA expression of TP, DPD, thymidylate synthase (TS) and orotate phosphoribosyl transferase (OPRT) are evaluated using reverse transcription polymerase chain reaction (RT-PCR). The patients’ clinical data reviewed are as follow: demographic and pathological characteristics, regimen, drug doses and treatment duration of adjuvant therapy, types and severity of adverse events, disease free survival, relapse free survival and overall survival. Then, relationships among the protein/mRNA expression, clinicopathological characteristics and the treatment outcomes are analyzed for each 5-FU derivative. A total of 2,128 patients from the 217 institutions were enrolled between April 2009 and March 2012. The B-CAST study demonstrated that large-scale, multicenter translational research using frozen samples was feasible when the sample shipment and Web-based data collection were well organized. The results

  10. A randomized clinical trial of methadone maintenance for prisoners: results at 12 months postrelease.

    Science.gov (United States)

    Kinlock, Timothy W; Gordon, Michael S; Schwartz, Robert P; Fitzgerald, Terrence T; O'Grady, Kevin E

    2009-10-01

    This study examined the impact of prison-initiated methadone maintenance at 12 months postrelease. Males with pre-incarceration heroin dependence (N = 204) were randomly assigned to (a) Counseling Only: counseling in prison, with passive referral to treatment upon release; (b) Counseling + Transfer: counseling in prison with transfer to methadone maintenance treatment upon release; and (c) Counseling + Methadone: counseling and methadone maintenance in prison, continued in the community upon release. The mean number of days in community-based drug abuse treatment were, respectively, Counseling Only, 23.1; Counseling + Transfer, 91.3; and Counseling + Methadone, 166.0 (p Counseling + Methadone participants were also significantly less likely than participants in each of the other two groups to be opioid-positive or cocaine-positive according to urine drug testing. These results support the effectiveness of prison-initiated methadone for males in the United States. Further study is required to confirm the findings for women.

  11. Outcomes of a Multi-Component Family Enrichment Project: 12-Month Follow-up

    Directory of Open Access Journals (Sweden)

    Sara Anne Tompkins

    2014-02-01

    Full Text Available Previous research has established that family enrichment programs work with a variety of populations (e.g., Hawkins, Stanley, Blanchard, & Albright, 2012. It is unclear if a multi-component program focusing on a variety of family outcomes can lead to lasting change. This study used growth modeling to examine effects of relationship (i.e., Within My Reach, parenting (i.e., Making Parenting a Pleasure, and financial enrichment (i.e., Spend Some, Save Some, Share Some classes over 12 months. Results revealed improvement in family functioning at one year post for all three programs. Program specific improvements included relationship functioning and parenting alliance. Program participants reported overall satisfaction and gaining of valuable skills. Findings suggest these family enrichment programs can have long-lasting effects; potential reasons for sample success and implications are discussed.

  12. Associations between positive and negative affect and 12-month physical disorders in a national sample.

    Science.gov (United States)

    Weiser, Eric B

    2012-06-01

    Associations between positive and negative affect and a range of 12-month physical disorders were investigated in the Midlife Development in the United States Survey, a nationally representative sample of 3,032 adults ages 25-74. These associations were examined, controlling for relevant sociodemographic and psychiatric covariates. High positive affect was associated with decreased risk of physical disorders, whereas high negative affect was associated with increased risk. However, associations between positive affect and physical disorders were partially attenuated following adjustment for concurrent negative affect. Additionally, high affect balance was associated with decreased risk of physical disorders before and after adjustments. These findings underscore the relevance of affective disposition in health status, suggesting that both positive and negative affect may serve as viable health risk parameters.

  13. Decrease in musculoskeletal pain after 4 and 12 months of an aerobic exercise intervention

    DEFF Research Database (Denmark)

    Korshøj, Mette; Birk Jørgensen, Marie; Lidegaard, Mark

    2018-01-01

    affects level of musculoskeletal pain from baseline to 4- and 12-months follow-up. METHODS: One-hundred-and-sixteen cleaners aged 18-65 years were cluster-randomized. The aerobic exercise group ( n = 57) received worksite aerobic exercise (30 min twice a week) and the reference group ( n = 59) lectures....... Aerobic exercise interventions among workers standing or walking in the majority of the working hours should tailor exercise to only maintain the positive effect on musculoskeletal pain.......BACKGROUND: Prevalence of musculoskeletal pain is high in jobs with high physical work demands. An aerobic exercise intervention targeting cardiovascular health was evaluated for its long term side effects on musculoskeletal pain. OBJECTIVE: The objective was to investigate if aerobic exercise...

  14. Knowledge and beliefs concerning early childhood caries from mothers of children ages zero to 12 months.

    Science.gov (United States)

    Azevedo, Marina Sousa; Romano, Ana Regina; Dos Santos, Iná da Silva; Cenci, Maximiliano Sergio

    2014-01-01

    This study's purpose was to assess mothers' knowledge and beliefs about early childhood caries (ECC) etiology and prevention. This cross-sectional study targeted mothers (N=277) of zero- to 12-month-olds visiting 12 public health care centers in Pelotas, Rio Grande do Sul, Brazil. Information on causes of and recommendations to prevent ECC, as well as socioeconomic and demographic variables, was collected. Chi-square, univariate, and multiple logistic regression analyses were performed (Pinfluence caries in their children. None reported the role of micro-organisms and lack of fluoride in the caries etiology. These findings highlight the importance of providing preventive orientation to the mothers regarding early childhood caries. Information on age of first dental visit should be emphasized, especially among mothers with more than one child and low-income families.

  15. A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.

    Science.gov (United States)

    Gordon, Michael S; Kinlock, Timothy W; Schwartz, Robert P; O'Grady, Kevin E; Fitzgerald, Terrence T; Vocci, Frank J

    2017-03-01

    This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting. Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs. Community Health Center (CHC)]×2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore pre-release prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release. Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=0.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>0.14) and no statistically significant hypothesized gender effects (all Ps>0.18). Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Factors associated with presenteeism among employed Australian adults reporting lifetime major depression with 12-month symptoms.

    Science.gov (United States)

    Cocker, Fiona; Martin, Angela; Scott, Jenn; Venn, Alison; Otahal, Petr; Sanderson, Kristy

    2011-12-01

    Employees experiencing depression can take a sickness absence or continue working ('presenteeism'). However, little is known about the factors associated with these behaviors within this population. This study aimed to determine the relative importance of socio-demographic, financial, work and health-related factors associated with presenteeism. The 2007 Australian National Survey of Mental Health and Wellbeing provided data from employed individuals reporting lifetime major depression with 12-month symptoms (N=320). Survey adjusted multivariable logistic regression assessed classification of 12-month, depression-related presenteeism on the basis of socio-demographic, financial, work and health factors. Acceptable classification of cases was 70% or greater. Classification of cases based on socio-demographic factors, age, sex and marital status, was reasonable (62%). Adding work factors (work hours and occupation type) produced a 1% increase in successfully classified cases (63%). Health factors further increased correctly classified cases (67%). Marital status, housing tenure and co-morbid mental disorders were important indicators of presenteeism behavior. Work-related variables were restricted to available measures. Potentially important psychosocial work environment factors were unavailable. Cross-sectional data precluded causal inference. Using available factors, model discrimination did not reach an acceptable level i.e. 70% of presenteeism cases successfully classified. This highlighted the contribution of unmeasured factors to presenteeism behavior. Future research should explore the relative importance of psychosocial work environment and personality factors such as work demands, effort/reward imbalance and conscientiousness. The identified associations between socio-demographic, financial and health factors on work attendance behaviors could inform disease management guidelines for employers via recognition of employees at risk of presenteeism. Copyright

  17. Mild pituitary phenotype in 3- and 12-month-old Aip-deficient male mice.

    Science.gov (United States)

    Lecoq, Anne-Lise; Zizzari, Philippe; Hage, Mirella; Decourtye, Lyvianne; Adam, Clovis; Viengchareun, Say; Veldhuis, Johannes D; Geoffroy, Valérie; Lombès, Marc; Tolle, Virginie; Guillou, Anne; Karhu, Auli; Kappeler, Laurent; Chanson, Philippe; Kamenický, Peter

    2016-10-01

    Germline mutations in the aryl hydrocarbon receptor-interacting protein (AIP) gene predispose humans to pituitary adenomas, particularly of the somatotroph lineage. Mice with global heterozygous inactivation of Aip (Aip(+/-)) also develop pituitary adenomas but differ from AIP-mutated patients by the high penetrance of pituitary disease. The endocrine phenotype of these mice is unknown. The aim of this study was to determine the endocrine phenotype of Aip(+/-) mice by assessing the somatic growth, ultradian pattern of GH secretion and IGF1 concentrations of longitudinally followed male mice at 3 and 12 months of age. As the early stages of pituitary tumorigenesis are controversial, we also studied the pituitary histology and somatotroph cell proliferation in these mice. Aip(+/-) mice did not develop gigantism but exhibited a leaner phenotype than wild-type mice. Analysis of GH pulsatility by deconvolution in 12-month-old Aip(+/-) mice showed a mild increase in total GH secretion, a conserved GH pulsatility pattern, but a normal IGF1 concentration. No pituitary adenomas were detected up to 12 months of age. An increased ex vivo response to GHRH of pituitary explants from 3-month-old Aip(+/-) mice, together with areas of enlarged acini identified on reticulin staining in the pituitary of some Aip(+/-) mice, was suggestive of somatotroph hyperplasia. Global heterozygous Aip deficiency in mice is accompanied by subtle increase in GH secretion, which does not result in gigantism. The absence of pituitary adenomas in 12-month-old Aip(+/-) mice in our experimental conditions demonstrates the important phenotypic variability of this congenic mouse model. © 2016 Society for Endocrinology.

  18. A survey of nutritional status of children 0-12 months in specialist hospital Gombe, Nigeria

    Directory of Open Access Journals (Sweden)

    Mela Danjin

    2015-01-01

    Full Text Available Background: This study was a cross-sectional survey of children and their mothers in specialist Hospital Gombe, Nigeria. Objective: Anthropometric assessment of nutritional status of the children (0-12 months and a survey of mothers′ opinion on malnutrition. Population: Children and mothers attending immunization sessions in specialist hospital Gombe, Nigeria. Materials and Methods: Hundred children (0-12 months attending immunization sessions were purposefully sampled and measured using sensitive anthropometric tools and techniques, while on the other arm of the study structured interviews were administered on the children′s consenting mothers (100 who turned in for their wards′ immunization. Only 97 out of 100 data collected on the children were used. Anthropometric indices used were height-for-age, weight-for-height, weight-for-age, and mid-upper arm circumference. Results: The study revealed a higher prevalence of moderate stunting in male (46.9% than in female (33.3% children (P 11 exhibited both severe and moderate forms of underweight. Among infants 3-5 months, moderate wasting was found to be less prevalent (4.2%. And despite the fact that 90% of their mothers showed a positive attitude toward exclusive breastfeeding, only 44% of them breastfed their infants exclusively from birth to the 6 th month of life. Conclusion: In order to address the various forms of nutritional derangements detected among the children, mothers should be targeted for infant nutritional education and authorities should institute poverty alleviation measures so as to address underlying causes of malnutrition.

  19. Maternal stress and psychological distress preconception: association with offspring atopic eczema at age 12 months.

    Science.gov (United States)

    El-Heis, S; Crozier, S R; Healy, E; Robinson, S M; Harvey, N C; Cooper, C; Inskip, H M; Baird, J; Godfrey, K M

    2017-06-01

    Perinatal maternal stress and low mood have been linked to offspring atopic eczema. To examine the relation of maternal stress/mood with atopic eczema in the offspring, focusing particularly on stress/psychological distress preconception. At recruitment in the UK Southampton Women's Survey, preconception maternal reports of perceived stress in daily living and the effect of stress on health were recorded; in a subsample, psychological distress was assessed (12-item General Health Questionnaire). Infants were followed up at ages 6 (n = 2956) and 12 (n = 2872) months and atopic eczema ascertained (based on UK Working Party Criteria for the Definition of Atopic Dermatitis). At 6 months post-partum, mothers were asked if they had experienced symptoms of low mood since childbirth and completed the Edinburgh Postnatal Depression Scale. Preconception perceived stress affecting health [OR 1.21 (95% CI 1.08-1.35), P = 0.001] and stress in daily living [OR 1.16 (1.03-1.30), P = 0.014] were associated with an increased risk of offspring atopic eczema at age 12 months but not at 6 months, robust to adjustment for potentially confounding variables. Findings were similar for maternal psychological distress preconception. Low maternal mood between delivery and 6 months post-partum was associated with an increased risk of infantile atopic eczema at age 12 months, but no significant association between post-natal mood and atopic eczema was seen after taking account of preconception stress. Our data provide novel evidence linking maternal stress at preconception to atopic eczema risk, supporting a developmental contribution to the aetiology of atopic eczema and pointing to potentially modifiable influences. © 2017 John Wiley & Sons Ltd.

  20. The Origins of 12-Month Attachment: A Microanalysis of 4-Month Mother-Infant Interaction

    Science.gov (United States)

    Beebe, Beatrice; Jaffe, Joseph; Markese, Sara; Buck, Karen; Chen, Henian; Cohen, Patricia; Bahrick, Lorraine; Andrews, Howard; Feldstein, Stanley

    2013-01-01

    A detailed microanalysis of 4-month mother-infant face-to-face communication revealed a fine-grained specification of essential communication processes that predicted 12-month insecure attachment outcomes, particularly resistant and disorganized classifications. An urban community sample of 84 dyads were videotaped at 4 months during a face-to-face interaction, and at 12 months during the Ainsworth Strange Situation. Four-month mother and infant communication modalities of attention, affect, touch, and spatial orientation were coded from split-screen videotape on a 1s time base; mother and infant facial-visual “engagement” variables were constructed. We used contingency measures (multi-level time-series modeling) to examine the dyadic temporal process over time, and specific rates of qualitative features of behavior to examine the content of behavior. Self-contingency (auto-correlation) measured the degree of stability/lability within an individual’s own rhythms of behavior; interactive contingency (lagged cross-correlation) measured adjustments of the individual’s behavior that were correlated with the partner’s previous behavior. We documented that both self- and interactive contingency, as well as specific qualitative features, of mother and infant behavior were mechanisms of attachment formation by 4 months, distinguishing 12-month insecure, resistant, and disorganized attachment classifications from secure; avoidant were too few to test. All communication modalities made unique contributions. The separate analysis of different communication modalities identified intermodal discrepancies or conflict, both intrapersonal and interpersonal, that characterized insecure dyads. Contrary to dominant theories in the literature on face-to-face interaction, measures of maternal contingent coordination with infant yielded the fewest associations with 12-month attachment, whereas mother and infant self-contingency, and infant contingent coordination with mother

  1. Excess Mortality Associated With Colistin-Tigecycline Compared With Colistin-Carbapenem Combination Therapy for Extensively Drug-Resistant Acinetobacter baumannii Bacteremia: A Multicenter Prospective Observational Study.

    Science.gov (United States)

    Cheng, Aristine; Chuang, Yu-Chung; Sun, Hsin-Yun; Sheng, Wang-Huei; Yang, Chia-Jui; Liao, Chun-Hsing; Hsueh, Po-Ren; Yang, Jia-Ling; Shen, Ni-Jiin; Wang, Jann-Tay; Hung, Chien-Ching; Chen, Yee-Chun; Chang, Shan-Chwen

    2015-06-01

    Since few therapeutic options exist for extensively drug resistant Acinetobacter baumannii, an emerging threat in ICUs worldwide, and comparative prospective studies of colistin-based combination therapies are lacking, our objective was to compare the outcomes of patients with extensively drug-resistant A. baumannii bacteremia, treated with colistin-carbapenem and colistin-tigecycline combinations. Prospective, observational, multicenter study. Adults with extensively drug-resistant A. baumannii bacteremia were prospectively followed from 2010 to 2013 at three hospitals in Taiwan. Extensively drug-resistant A. baumannii was defined as A. baumannii (genospecies 2) nonsusceptible to all drug classes except for colistin and tigecycline, and standard combination therapy as use of parenteral colistin-carbapenem or colistin-tigecycline for at least 48 hours after onset of bacteremia. Primary outcome measure was 14-day mortality. Of the 176 episodes of extensively drug-resistant A. baumannii bacteremia evaluated, 55 patients with a median (interquartile range) age of 62 years (44-79 yr) and Sequential Organ Failure Assessment score of 9 (5-13) points received standard combination therapy: colistin-tigecycline in 29 patients and colistin-carbapenem in 26. Crude 14-day and in-hospital mortality rates for patients receiving colistin-tigecycline versus patients receiving colistin-carbapenem were 35% versus 15% (p=0.105) and 69% versus 50% (p=0.152), respectively. Breakthrough extensively drug-resistant A. baumannii bacteremia under steady state concentrations of combination therapy for colistin-tigecycline group was 18% and for colistin-carbapenem group was 0% (p=0.059). Eleven patients (20.0%) developed nephrotoxicity. After adjusting for age, sex, comorbidity, initial disease severity, loading colistin dose, polymicrobial infection, and primary infection site, excess 14-day mortality was associated with the use of colistin-tigecycline in the subgroup with tigecycline

  2. Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: a multicenter prospective study (PLASTIC-study).

    Science.gov (United States)

    Brenkman, H J F; Gertsen, E C; Vegt, E; van Hillegersberg, R; van Berge Henegouwen, M I; Gisbertz, S S; Luyer, M D P; Nieuwenhuijzen, G A P; van Lanschot, J J B; Lagarde, S M; de Steur, W O; Hartgrink, H H; Stoot, J H M B; Hulsewe, K W E; Spillenaar Bilgen, E J; van Det, M J; Kouwenhoven, E A; van der Peet, D L; Daams, F; van Sandick, J W; van Grieken, N C T; Heisterkamp, J; van Etten, B; Haveman, J W; Pierie, J P; Jonker, F; Thijssen, A Y; Belt, E J T; van Duijvendijk, P; Wassenaar, E; van Laarhoven, H W M; Wessels, F J; Haj Mohammad, N; van Stel, H F; Frederix, G W J; Siersema, P D; Ruurda, J P

    2018-04-20

    Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy. In locally advanced (cT3-4) gastric cancer, fluorodeoxyglucose positron emission tomography with CT (FDG-PET/CT or PET) and staging laparoscopy (SL) may have a role in staging, but evidence is scarce. The aim of this study is to evaluate the impact and cost-effectiveness of PET and SL in addition to initial staging in patients with locally advanced gastric cancer. This prospective observational cohort study will include all patients with a surgically resectable, advanced gastric adenocarcinoma (cT3-4b, N0-3, M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT. The modalities to be investigated in this study is the addition of PET and SL. The primary outcome of this study is the proportion of patients in whom the PET or SL lead to a change in treatment strategy. Secondary outcome parameters are: diagnostic performance, morbidity and mortality, quality of life, and cost-effectiveness of these additional diagnostic modalities. The study recently started in August 2017 with a duration of 36 months. At least 239 patients need to be included in this study to demonstrate that the diagnostic modalities are break-even. Based on the annual number of gastrectomies in the participating centers, it is estimated that approximately 543 patients are included in this study. In this study, it is hypothesized that performing PET and SL for locally advanced gastric adenocarcinomas results in a change of treatment strategy in 27% of patients and an annual cost-reduction in the Netherlands of €916.438 in this patient group by reducing futile treatment. The results of this study may be applicable to all countries with comparable treatment algorithms and health care systems. NCT03208621 . This trial was registered prospectively on June 30, 2017.

  3. PROGNOSTIC SIGNIFICANCE OF CLINICAL, HISTOPATHOLOGICAL, AND MOLECULAR CHARACTERISTICS OF MEDULLOBLASTOMAS IN THE PROSPECTIVE HIT2000 MULTICENTER CLINICAL TRIAL COHORT

    Science.gov (United States)

    Pietsch, Torsten; Schmidt, Rene; Remke, Marc; Korshunov, Andrey; Hovestadt, Volker; Jones, David TW; Felsberg, Jörg; Kaulich, Kerstin; Goschzik, Tobias; Kool, Marcel; Northcott, Paul A.; von Hoff, Katja; von Bueren, André O.; Friedrich, Carsten; Skladny, Heyko; Fleischhack, Gudrun; Taylor, Michael D.; Cremer, Friedrich; Lichter, Peter; Faldum, Andreas; Reifenberger, Guido; Rutkowski, Stefan; Pfister, Stefan M.

    2014-01-01

    BACKGROUND: This study aimed to prospectively evaluate clinical, histopathological and molecular variables for outcome prediction in medulloblastoma patients. METHODS: Patients from the HIT2000 cooperative clinical trial were prospectively enrolled based on the availability of sufficient tumor material and complete clinical information. This revealed a cohort of 184 patients (median age 7.6 years), which was randomly split at a 2:1 ratio into a training (n = 127), and a validation (n = 57) dataset. All samples were subjected to thorough histopathological investigation, CTNNB1 mutation analysis, quantitative PCR, MLPA and FISH analyses for cytogenetic variables, and methylome analysis. RESULTS: By univariable analysis, clinical factors (M-stage), histopathological variables (large cell component, endothelial proliferation, synaptophysin pattern), and molecular features (chromosome 6q status, MYC amplification, TOP2A copy-number, subgrouping) were found to be prognostic. Molecular consensus subgrouping (WNT, SHH, Group 3, Group 4) was validated as an independent feature to stratify patients into different risk groups. When comparing methods for the identification of WNT-driven medulloblastoma, this study identified CTNNB1 sequencing and methylation profiling to most reliably identify these patients. After removing patients with particularly favorable (CTNNB1 mutation, extensive nodularity) or unfavorable (MYC amplification) markers, a risk score for the remaining “intermediate molecular risk” population dependent on age, M-stage, pattern of synaptophysin expression, and MYCN copy-number status was identified and validated, with speckled synaptophysin expression indicating worse outcome. CONCLUSIONS: Methylation subgrouping and CTNNB1 mutation status represent robust tools for the risk-stratification of medulloblastoma. A simple clinico-pathological risk score for “intermediate molecular risk” patients was identified, which deserves further validation

  4. Large-scale prospective T cell function assays in shipped, unfrozen blood samples: experiences from the multicenter TRIGR trial.

    Science.gov (United States)

    Hadley, David; Cheung, Roy K; Becker, Dorothy J; Girgis, Rose; Palmer, Jerry P; Cuthbertson, David; Krischer, Jeffrey P; Dosch, Hans-Michael

    2014-02-01

    Broad consensus assigns T lymphocytes fundamental roles in inflammatory, infectious, and autoimmune diseases. However, clinical investigations have lacked fully characterized and validated procedures, equivalent to those of widely practiced biochemical tests with established clinical roles, for measuring core T cell functions. The Trial to Reduce Insulin-dependent diabetes mellitus in the Genetically at Risk (TRIGR) type 1 diabetes prevention trial used consecutive measurements of T cell proliferative responses in prospectively collected fresh heparinized blood samples shipped by courier within North America. In this article, we report on the quality control implications of this simple and pragmatic shipping practice and the interpretation of positive- and negative-control analytes in our assay. We used polyclonal and postvaccination responses in 4,919 samples to analyze the development of T cell immunocompetence. We have found that the vast majority of the samples were viable up to 3 days from the blood draw, yet meaningful responses were found in a proportion of those with longer travel times. Furthermore, the shipping time of uncooled samples significantly decreased both the viabilities of the samples and the unstimulated cell counts in the viable samples. Also, subject age was significantly associated with the number of unstimulated cells and T cell proliferation to positive activators. Finally, we observed a pattern of statistically significant increases in T cell responses to tetanus toxin around the timing of infant vaccinations. This assay platform and shipping protocol satisfy the criteria for robust and reproducible long-term measurements of human T cell function, comparable to those of established blood biochemical tests. We present a stable technology for prospective disease-relevant T cell analysis in immunological diseases, vaccination medicine, and measurement of herd immunity.

  5. A Prospective, Multicenter Study of Complementary/Alternative Medicine (CAM) Utilization During Definitive Radiation for Breast Cancer

    International Nuclear Information System (INIS)

    Moran, Meena S.; Ma Shuangge; Jagsi, Reshma; Yang, Tzu-I Jonathan; Higgins, Susan A.; Weidhaas, Joanne B.; Wilson, Lynn D.; Lloyd, Shane; Peschel, Richard; Gaudreau, Bryant; Rockwell, Sara

    2013-01-01

    Purpose: Although complementary and alternative medicine (CAM) utilization in breast cancer patients is reported to be high, there are few data on CAM practices in breast patients specifically during radiation. This prospective, multi-institutional study was conducted to define CAM utilization in breast cancer during definitive radiation. Materials/Methods: A validated CAM instrument with a self-skin assessment was administered to 360 Stage 0-III breast cancer patients from 5 centers during the last week of radiation. All data were analyzed to detect significant differences between users/nonusers. Results: CAM usage was reported in 54% of the study cohort (n=194/360). Of CAM users, 71% reported activity-based CAM (eg, Reiki, meditation), 26% topical CAM, and 45% oral CAM. Only 16% received advice/counseling from naturopathic/homeopathic/medical professionals before initiating CAM. CAM use significantly correlated with higher education level (P<.001), inversely correlated with concomitant hormone/radiation therapy use (P=.010), with a trend toward greater use in younger patients (P=.066). On multivariate analysis, level of education (OR: 6.821, 95% CI: 2.307-20.168, P<.001) and hormones/radiation therapy (OR: 0.573, 95% CI: 0.347-0.949, P=.031) independently predicted for CAM use. Significantly lower skin toxicity scores were reported in CAM users vs nonusers, respectively (mild: 34% vs 25%, severe: 17% vs 29%, P=.017). Conclusion: This is the first prospective study to assess CAM practices in breast patients during radiation, with definition of these practices as the first step for future investigation of CAM/radiation interactions. These results should alert radiation oncologists that a large percentage of breast cancer patients use CAM during radiation without disclosure or consideration for potential interactions, and should encourage increased awareness, communication, and documentation of CAM practices in patients undergoing radiation treatment for breast

  6. Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.

    Science.gov (United States)

    Hequet, Delphine; Callens, Céline; Gentien, David; Albaud, Benoit; Mouret-Reynier, Marie-Ange; Dubot, Coraline; Cottu, Paul; Huchon, Cyrille; Zilberman, Sonia; Berseneff, Helene; Foa, Cyril; Salmon, Rémy; Roulot, Aurélie; Lerebours, Florence; Salomon, Anne; Ghali, Nadeem; Morel, Pascale; Li, Qianyi; Cayre, Anne; Guinebretière, Jean-Marc; Hornberger, John; Penault-Llorca, Frédérique; Rouzier, Roman

    2017-01-01

    The Prosigna® breast cancer prognostic gene signature assay identifies a gene-expression profile that permits the classification of tumors into subtypes and gives a score for the risk of recurrence (ROR) at 10 years. The primary objective of this multicenter study was to evaluate the impact of Prosigna's assay information on physicians' adjuvant treatment decisions in patients with early-stage breast cancer. Secondary objectives were to assess confidence of practitioners in their therapeutic recommendations before and after the added information provided by the Prosigna assay; and to evaluate the emotional state of patients before and after the Prosigna test results. Consecutive patients with invasive early-stage breast cancer were enrolled in a prospective, observational, multicenter study carried out in 8 hospitals in France. The Prosigna test was carried out on surgical specimens using the nCounter® Analysis System located at the Institut Curie. Both before and after receiving the Prosigna test results, physicians completed treatment confidence questionnaires and patients completed questionnaires concerning their state of anxiety, the difficulties felt in face of the therapy and quality of life. Information was also collected at 6 months regarding the physicians' opinion on the test results and the patients' degree of anxiety, difficulties with therapy and quality of life. Between March 2015 and January 2016, 8 study centers in France consecutively enrolled 210 postmenopausal women with estrogen receptor (ER) positive, human epidermal growth hormone-2 (HER-2) negative, and node negative tumors, either stage 1 or stage 2. Intrinsic tumor subtypes as assessed by the Prosigna test were 114 (58.2%) Luminal A, 79 (40.3%) Luminal B, 1 (0.5%) HER-2 enriched (HER-2E), and 2 (1.0%) basal-like. Before receiving the Prosigna test results, physicians categorized tumor subtypes based on immunohistochemistry (IHC) as Luminal A in 126 (64%) patients and Luminal B in 70 (36

  7. Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.

    Directory of Open Access Journals (Sweden)

    Delphine Hequet

    Full Text Available The Prosigna® breast cancer prognostic gene signature assay identifies a gene-expression profile that permits the classification of tumors into subtypes and gives a score for the risk of recurrence (ROR at 10 years. The primary objective of this multicenter study was to evaluate the impact of Prosigna's assay information on physicians' adjuvant treatment decisions in patients with early-stage breast cancer. Secondary objectives were to assess confidence of practitioners in their therapeutic recommendations before and after the added information provided by the Prosigna assay; and to evaluate the emotional state of patients before and after the Prosigna test results.Consecutive patients with invasive early-stage breast cancer were enrolled in a prospective, observational, multicenter study carried out in 8 hospitals in France. The Prosigna test was carried out on surgical specimens using the nCounter® Analysis System located at the Institut Curie. Both before and after receiving the Prosigna test results, physicians completed treatment confidence questionnaires and patients completed questionnaires concerning their state of anxiety, the difficulties felt in face of the therapy and quality of life. Information was also collected at 6 months regarding the physicians' opinion on the test results and the patients' degree of anxiety, difficulties with therapy and quality of life.Between March 2015 and January 2016, 8 study centers in France consecutively enrolled 210 postmenopausal women with estrogen receptor (ER positive, human epidermal growth hormone-2 (HER-2 negative, and node negative tumors, either stage 1 or stage 2. Intrinsic tumor subtypes as assessed by the Prosigna test were 114 (58.2% Luminal A, 79 (40.3% Luminal B, 1 (0.5% HER-2 enriched (HER-2E, and 2 (1.0% basal-like. Before receiving the Prosigna test results, physicians categorized tumor subtypes based on immunohistochemistry (IHC as Luminal A in 126 (64% patients and Luminal B in

  8. Dichorionic twin ultrasound surveillance: sonography every 4 weeks significantly underperforms sonography every 2 weeks: results of the Prospective Multicenter ESPRiT Study.

    Science.gov (United States)

    Corcoran, Siobhan; Breathnach, Fionnuala; Burke, Gerard; McAuliffe, Fionnuala; Geary, Michael; Daly, Sean; Higgins, John; Hunter, Alyson; Morrison, John J; Higgins, Shane; Mahony, Rhona; Dicker, Patrick; Tully, Elizabeth; Malone, Fergal D

    2015-10-01

    A 2-week ultrasound scanning schedule for monochorionic twins is endorsed widely. There is a lack of robust data to inform a schedule for the surveillance of dichorionic gestations. We aimed to determine how ultrasound scanning that is performed at 2- or 4-week intervals (or every 4 weeks before 32 weeks' gestation and every 2 weeks thereafter) may impact the prenatal detection of fetal growth restriction (FGR) and ultimately influence timing of delivery. In a consecutive cohort of 789 dichorionic twin pregnancies that were recruited prospectively for the multicenter Evaluation of Sonographic Predictors of Restricted Growth in Twins study, ultrasound determination of fetal growth and interrogation of umbilical and middle cerebral artery Doppler scans were performed every 2 weeks from 24 weeks' gestation until delivery. Complete delivery and perinatal outcome data were recorded for all pregnancies. Where delivery was prompted by FGR, abnormal umbilical artery Doppler examination or poor biophysical profile and in the absence of ruptured membranes, onset of labor, preeclampsia, or antepartum hemorrhage, the delivery was considered "ultrasound-indicated." For ultrasound-indicated deliveries, detection probabilities for FGR/abnormal umbilical artery Doppler scans/poor biophysical were determined according to the interval between examinations, by the suppression if alternate examination data. Among 789 dichorionic twin pregnancies, 66 pairs (8%) had an "ultrasound indicated" delivery. Detection of FGR was reduced from 88-69%, and detection of abnormal umbilical artery Doppler was reduced from 82-62% when a 4-week ultrasound schedule was simulated. Both of these reductions reached statistical significance. There was a nonsignificant trend toward a reduction in the recording of oligohydramnios with a 4-week interval between examinations. This study suggests that the ultrasound surveillance program of every 2 weeks that is recommended currently for monochorionic twins

  9. [The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study].

    Science.gov (United States)

    Rafal'skiĭ, V V; Dovgan', E V; Kozyrev, Iu V; Gustovarova, T A; Khlybova, S V; Novoselova, A V; Filippenko, N G; Likhikh, D G

    2013-01-01

    The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25.2 +/- 6.6; in group 2--26.6 +/- 5.8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94.8 and 92.7% of women treated with cefixime, and in 98.2 and 92.5% of women treated with amoxicillin/clavulanate, respectively (P > 0.05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1.7; respectively; P = 0.02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

  10. Do patients in Dutch nursing homes have more pressure ulcers than patients in German nursing homes? A prospective multicenter cohort study.

    Science.gov (United States)

    Meesterberends, Esther; Halfens, Ruud J G; Spreeuwenberg, Marieke D; Ambergen, Ton A W; Lohrmann, Christa; Neyens, Jacques C L; Schols, Jos M G A

    2013-08-01

    To investigate whether the incidence of pressure ulcers in nursing homes in the Netherlands and Germany differs and, if so, to identify resident-related risk factors, nursing-related interventions, and structural factors associated with pressure ulcer development in nursing home residents. A prospective multicenter cohort study. Ten nursing homes in the Netherlands and 11 nursing homes in Germany (around Berlin and Brandenburg). A total of 547 newly admitted nursing home residents, of which 240 were Dutch and 307 were German. Residents had an expected length of stay of 12 weeks or longer. Data were collected for each resident over a 12-week period and included resident characteristics (eg, demographics, medical history, Braden scale scores, nutritional factors), pressure ulcer prevention and treatment characteristics, staffing ratios and other structural nursing home characteristics, and outcome (pressure ulcer development during the study). Data were obtained by trained research assistants. A significantly higher pressure ulcer incidence rate was found for the Dutch nursing homes (33.3%) compared with the German nursing homes (14.3%). Six factors that explain the difference in pressure ulcer incidence rates were identified: dementia, analgesics use, the use of transfer aids, repositioning the residents, the availability of a tissue viability nurse on the ward, and regular internal quality controls in the nursing home. The pressure ulcer incidence was significantly higher in Dutch nursing homes than in German nursing homes. Factors related to residents, nursing care and structure explain this difference in incidence rates. Continuous attention to pressure ulcer care is important for all health care settings and countries, but Dutch nursing homes especially should pay more attention to repositioning residents, the necessity and correct use of transfer aids, the necessity of analgesics use, the tasks of the tissue viability nurse, and the performance of regular

  11. The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

    Science.gov (United States)

    Ziemssen, Tjalf; Kern, Raimar; Cornelissen, Christian

    2015-06-18

    Fingolimod (Gilenya) is an oral medication for patients with highly active relapsing-remitting Multiple Sclerosis (RRMS). Clinical trials and post-marketing experience on more than 114,000 patients have established a detailed safety profile. Total patient exposure now exceeds 195,000 patient-years as stated in the last financial report (Dec 2014) of the Novartis Pharma AG, Basel, Switzerland. However, less is known about the safety of long-term fingolimod use in daily practice. Here, we describe the study design of PANGAEA (Post-Authorization Non-interventional German sAfety of GilEnyA in RRMS patients), a prospective, multicenter, non-interventional, long-term study to collect safety, efficacy, and pharmacoeconomic data on RRMS patients treated with fingolimod (0.5 mg/daily) under real-world conditions in Germany. PANGAEA is striving to assess a real-world safety and efficacy profile of fingolimod, based on data from 4,000 RRMS patients, obtained during a 60-month observational phase. A pharmacoeconomic sub-study of 800 RRMS patients further collects patient-reported outcome measures of disability, quality of life, compliance, treatment satisfaction, and usage of resources during a 24-month observational phase. Descriptive statistical analyses of the safety set as well as of stratified subgroups such as patients with concomitant diabetes mellitus and pretreated patients (e.g., natalizumab) will be conducted. PANGAEA seeks to confirm the current safety profile of fingolimod obtained in phase I-III clinical trials. The study design presented here will additionally provide guidance on the therapeutic use of fingolimod in clinical practice and possibly assists physicians in making evidence-based decisions.

  12. Clinical effectiveness and safety of OROS® hydromorphone in break-through cancer pain treatment: a multicenter, prospective, open-label study in Korean patients.

    Science.gov (United States)

    Lee, Kyung Hee; Kim, Min Kyoung; Hyun, Myung Soo; Kim, Jin Young; Park, Keon Uk; Song, Hong Suk; Lee, Sun Ah; Lee, Won Sik; Bae, Sung Hwa; Ryoo, Hun Mo; Cho, Yoon Young

    2012-01-01

    To evaluate the effectiveness of OROS® hydromorphone in reducing breakthrough pain (BTP) medication frequency in Korean patients with chronic cancer pain. Multicenter, prospective, open-label, phase IV study. Patients with chronic malignant pain using immediate-release oxycodone more than two times per day for BTP. Patients were stabilized on their ongoing drug for 3 days immediately before baseline measurements (day 0). Medication was changed to OROS® hydromorphone at a dose equianalgesic to oxycodone using a 2.5:1 controlled-release oxycodone to hydromorphone hydrochloride conversion ratio; the patients were observed for 7 days. Dose was titrated, if required, and the patients were observed for another 7 days. Effectiveness and safety parameters were measured at baseline, day 7, and day 14. BTP medication frequency on days 7 and 14, compared to baseline. Of the 141 patients screened, 114 received study drug and 98 completed the study. Compared to day 0, daily BTP medication frequency on day 14 decreased from 2.93 to 2.00 (p > 0.0001), daily BTP frequency decreased from 3.67 to 2.44 (p > 0.0001), and end-of-dose pain frequency decreased by 44 percent. Pain was controlled adequately during daytime and night-time. Pain intensity decreased by 11 percent as assessed using the Korean Brief Pain Inventory and by 17 percent as assessed using the numerical rating scale. About 61.2 percent patients and 60.2 percent physicians were satisfied with the treatment. Common adverse events, which occurred in 91.2 percent patients, were constipation, somnolence, and dizziness. Once-daily OROS® hydromorphone is efficient in the reduction of cancer pain-related BTP episodes, including end-of-dose pain.

  13. Clinical effectiveness of hymenoptera venom immunotherapy: a prospective observational multicenter study of the European academy of allergology and clinical immunology interest group on insect venom hypersensitivity.

    Science.gov (United States)

    Ruëff, Franziska; Przybilla, Bernhard; Biló, Maria Beatrice; Müller, Ulrich; Scheipl, Fabian; Seitz, Michael J; Aberer, Werner; Bodzenta-Lukaszyk, Anna; Bonifazi, Floriano; Campi, Paolo; Darsow, Ulf; Haeberli, Gabrielle; Hawranek, Thomas; Küchenhoff, Helmut; Lang, Roland; Quercia, Oliviero; Reider, Norbert; Schmid-Grendelmeier, Peter; Severino, Maurizio; Sturm, Gunter Johannes; Treudler, Regina; Wüthrich, Brunello

    2013-01-01

    Treatment failure during venom immunotherapy (VIT) may be associated with a variety of risk factors. Our aim was to evaluate the association of baseline serum tryptase concentration (BTC) and of other parameters with the frequency of VIT failure during the maintenance phase. In this observational prospective multicenter study, we followed 357 patients with established honey bee or vespid venom allergy after the maintenance dose of VIT had been reached. In all patients, VIT effectiveness was either verified by sting challenge (n = 154) or patient self-reporting of the outcome of a field sting (n = 203). Data were collected on BTC, age, gender, preventive use of anti-allergic drugs (oral antihistamines and/or corticosteroids) right after a field sting, venom dose, antihypertensive medication, type of venom, side effects during VIT, severity of index sting reaction preceding VIT, and duration of VIT. Relative rates were calculated with generalized additive models. 22 patients (6.2%) developed generalized symptoms during sting challenge or after a field sting. A strong association between the frequency of VIT failure and BTC could be excluded. Due to wide confidence bands, however, weaker effects (odds ratios <3) of BTC were still possible, and were also suggested by a selective analysis of patients who had a sting challenge. The most important factor associated with VIT failure was a honey bee venom allergy. Preventive use of anti-allergic drugs may be associated with a higher protection rate. It is unlikely that an elevated BTC has a strong negative effect on the rate of treatment failures. The magnitude of the latter, however, may depend on the method of effectiveness assessment. Failure rate is higher in patients suffering from bee venom allergy.

  14. Clinical effectiveness of hymenoptera venom immunotherapy: a prospective observational multicenter study of the European academy of allergology and clinical immunology interest group on insect venom hypersensitivity.

    Directory of Open Access Journals (Sweden)

    Franziska Ruëff

    Full Text Available BACKGROUND: Treatment failure during venom immunotherapy (VIT may be associated with a variety of risk factors. OBJECTIVE: Our aim was to evaluate the association of baseline serum tryptase concentration (BTC and of other parameters with the frequency of VIT failure during the maintenance phase. METHODS: In this observational prospective multicenter study, we followed 357 patients with established honey bee or vespid venom allergy after the maintenance dose of VIT had been reached. In all patients, VIT effectiveness was either verified by sting challenge (n = 154 or patient self-reporting of the outcome of a field sting (n = 203. Data were collected on BTC, age, gender, preventive use of anti-allergic drugs (oral antihistamines and/or corticosteroids right after a field sting, venom dose, antihypertensive medication, type of venom, side effects during VIT, severity of index sting reaction preceding VIT, and duration of VIT. Relative rates were calculated with generalized additive models. RESULTS: 22 patients (6.2% developed generalized symptoms during sting challenge or after a field sting. A strong association between the frequency of VIT failure and BTC could be excluded. Due to wide confidence bands, however, weaker effects (odds ratios <3 of BTC were still possible, and were also suggested by a selective analysis of patients who had a sting challenge. The most important factor associated with VIT failure was a honey bee venom allergy. Preventive use of anti-allergic drugs may be associated with a higher protection rate. INTERPRETATION: It is unlikely that an elevated BTC has a strong negative effect on the rate of treatment failures. The magnitude of the latter, however, may depend on the method of effectiveness assessment. Failure rate is higher in patients suffering from bee venom allergy.

  15. Evaluation of clinical safety and beneficial effects of a fish oil containing lipid emulsion (Lipoplus, MLF541): data from a prospective, randomized, multicenter trial.

    Science.gov (United States)

    Wichmann, Matthias W; Thul, Paul; Czarnetzki, Hans-Dieter; Morlion, Bart J; Kemen, Matthias; Jauch, Karl-Walter

    2007-03-01

    To prove safety and effectiveness of a lipid emulsion enriched with n-3 fatty acids from fish oil (Lipoplus) within the setting of parenteral nutrition of patients after major abdominal surgery and to determine whether there are effects on outcome parameters. Prospective, randomized, double-blind, multicenter trial. University and surgical teaching hospitals. After obtaining informed consent, 256 patients undergoing major abdominal surgery were randomized. Parameters of safety, effectiveness, and outcome were routine laboratory parameters, complication rates, length of stay in the intensive care unit, and length of hospital stay. In addition we determined in patient subgroups of 30 patients each, the changes of the content of selected long-chain polyunsaturated fatty acids, the leukotriene synthetic capacity and the antioxidant alpha-tocopherol. Participating patients were randomized to receive either Lipoplus (group I; n = 127 patients) or Intralipid (group II; n = 129 patients). Parenteral nutrition was initiated immediately after surgery and ended on day 5 after surgery. No significant differences between groups I and II were observed when comparing routine laboratory parameters during the perioperative period. Plasma levels of eicosapentaenoic acid, leukotriene B5, and antioxidant content were significantly increased in group I. Furthermore, there was a significantly shorter length of hospital stay of approximately 21% (17.2 vs. 21.9 days; p = .0061) in group I. Our findings indicate that the administration of Lipoplus in the postoperative period after major abdominal surgery is safe and results in a significantly shorter length of hospital stay. Administration of n-3 polyunsaturated fatty acids in the postoperative period can be considered a valuable choice for patients requiring parenteral nutrition after major abdominal surgery.

  16. Empty polyetheretherketone (PEEK) cages in anterior cervical diskectomy and fusion (ACDF) show slow radiographic fusion that reduces clinical improvement: results from the prospective multicenter "PIERCE-PEEK" study.

    Science.gov (United States)

    Suess, Olaf; Schomaker, Martin; Cabraja, Mario; Danne, Marco; Kombos, Theodoros; Hanna, Michael

    2017-01-01

    Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment for radiculopathy and myelopathy. Previous studies showed that empty PEEK cages have lower radiographic fusion rates, but the clinical relevance remains unclear. This paper's aim is to provide high-quality evidence on the outcomes of ACDF with empty PEEK cages and on the relevance of radiographic fusion for clinical outcomes. This large prospective multicenter clinical trial performed single-level ACDF with empty PEEK cages on patients with cervical radiculopathy or myelopathy. The main clinical outcomes were VAS (0-10) for pain and NDI (0-100) for functioning. Radiographic fusion was evaluated by two investigators for three different aspects. The median (range) improvement of the VAS pain score was: 3 (1-6) at 6 months, 3 (2-8) at 12 months, and 4 (2-8) at 18 months. The median (range) improvement of the NDI score was: 12 (2-34) at 6 months, 18 (4-46) at 12 months, and 22 (2-44) at 18 months. Complete radiographic fusion was reached by 126 patients (43%) at 6 months, 214 patients (73%) at 12 months, and 241 patients (83%) at 18 months. Radiographic fusion was a highly significant ( p  PEEK cages is slow and insufficient. Lack of complete radiographic fusion leads to less improvement of pain and disability. We recommend against using empty uncoated pure PEEK cages in ACDF. ISRCTN42774128. Retrospectively registered 14 April 2009.

  17. Safety of gadobutrol in more than 1,000 pediatric patients: subanalysis of the GARDIAN study, a global multicenter prospective non-interventional study

    International Nuclear Information System (INIS)

    Glutig, Katja; Bhargava, Ravi; Hahn, Gabriele; Hirsch, Wolfgang; Kunze, Christian; Mentzel, Hans-Joachim; Schaefer, Juergen F.; Willinek, Winfried; Palkowitsch, Petra

    2016-01-01

    Gadobutrol is a gadolinium-based contrast agent, uniquely formulated at 1.0 mmol/ml. Although there is extensive safety evidence on the use of gadobutrol in adults, few studies have addressed the safety and tolerability of gadobutrol in pediatric patients. This subanalysis of data from the GARDIAN study evaluated the safety and use of gadobutrol in pediatric patients (age <18 years). The GARDIAN study was a large phase IV non-interventional prospective multicenter post-authorization safety study performed in Europe, Asia, North America and Africa. A total of 23,708 patients were included who were scheduled to undergo cranial or spinal MRI, liver or kidney MRI, or MR angiography with gadobutrol enhancement. The primary study endpoint was the overall incidence of adverse drug reactions (ADRs) and serious adverse events (SAEs) following gadobutrol administration. The GARDIAN study included 1,142 children (age <18 years) who received gadobutrol at a mean dose of 0.13 (range 0.04-0.50) mmol/kg body weight. Gadobutrol was well tolerated in these children, with low rates of ADRs (0.5%) and no SAEs, consistent with results in adults enrolled in the GARDIAN study. Rates of adverse events and ADRs were unrelated to pediatric age or gadobutrol weight-adjusted dose. There were no symptoms suggestive of nephrogenic systemic fibrosis. Investigators rated the contrast quality of gadobutrol-enhanced images as good or excellent in 97.8% of pediatric patients, similar to the main study population. Gadobutrol is very well tolerated and provides excellent contrast quality at the recommended weight-adjusted dose in children (age <18 years), similar to the profile in adults. (orig.)

  18. Surgical perspectives from a prospective, nonrandomized, multicenter study of breast conserving surgery and adjuvant electronic brachytherapy for the treatment of breast cancer

    Directory of Open Access Journals (Sweden)

    Beatty J David

    2011-03-01

    Full Text Available Abstract Background Accelerated partial breast irradiation (APBI may be used to deliver radiation to the tumor bed post-lumpectomy in eligible patients with breast cancer. Patient and tumor characteristics as well as the lumpectomy technique can influence patient eligibility for APBI. This report describes a lumpectomy procedure and examines patient, tumor, and surgical characteristics from a prospective, multicenter study of electronic brachytherapy. Methods The study enrolled 65 patients of age 45-84 years with ductal carcinoma or ductal carcinoma in situ, and 44 patients, who met the inclusion and exclusion criteria, were treated with APBI using the Axxent® electronic brachytherapy system following lumpectomy. The prescription dose was 34 Gy in 10 fractions over 5 days. Results The lumpectomy technique as described herein varied by site and patient characteristics. The balloon applicator was implanted by the surgeon (91% or a radiation oncologist (9% during or up to 61 days post-lumpectomy (mean 22 days. A lateral approach was most commonly used (59% for insertion of the applicator followed by an incision site approach in 27% of cases, a medial approach in 5%, and an inferior approach in 7%. A trocar was used during applicator insertion in 27% of cases. Local anesthetic, sedation, both or neither were administered in 45%, 2%, 41% and 11% of cases, respectively, during applicator placement. The prescription dose was delivered in 42 of 44 treated patients. Conclusions Early stage breast cancer can be treated with breast conserving surgery and APBI using electronic brachytherapy. Treatment was well tolerated, and these early outcomes were similar to the early outcomes with iridium-based balloon brachytherapy.

  19. Prospective multicenter validation of the Glasgow Blatchford bleeding score in the management of patients with upper gastrointestinal hemorrhage presenting at an emergency department.

    Science.gov (United States)

    Aquarius, Michel; Smeets, Fabiënne G M; Konijn, Helena W; Stassen, Patricia M; Keulen, Eric T; Van Deursen, Cees T; Masclee, Ad A M; Keulemans, Yolande C

    2015-09-01

    The Glasgow Blatchford Bleeding Score (GBS) has been developed to assess the need for treatment in patients with acute upper gastrointestinal hemorrhage (UGIH) presenting at emergency departments (EDs). We aimed (a) to determine the validity of the GBS and Rockall scoring systems for prediction of need for treatment and (b) to identify the optimal cut-off value of the GBS. We carried out a population-based, prospective multicenter study of 520 consecutive patients presenting with acute UGIH at EDs of three hospitals. The accuracy of GBS and Rockall scores in predicting the need for treatment (i.e. endoscopic, surgical, or radiological intervention and blood transfusion) was analyzed using receiver operating characteristic curves. Receiver operating characteristic curve analysis showed that the GBS had a good discriminative ability to determine the need for treatment in patients with acute UGIH (area under the curve: 0.88; 95% confidence interval: 0.85-0.91). The GBS was superior to both the clinical Rockall and the full Rockall score in predicting the need for treatment (area under the curve: 0.86 vs. 0.70 vs. 0.77). At a cut-off value of up to 2, the GBS had the optimal combination of sensitivity (99.4%) and specificity (42.4%). The GBS is superior compared with both Rockall scores in predicting the need for treatment in patients with suspected acute UGIH presenting at EDs in the Netherlands. Patients with a GBS of 2 or less form a subgroup of low-risk patients. These low-risk patients are eligible for outpatient management, which might reduce hospital admissions and healthcare costs.

  20. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial.

    Science.gov (United States)

    Marsen, Tobias A; Beer, Justinus; Mann, Helmut

    2017-02-01

    Protein-energy wasting (PEW) is increasingly becoming a clinical problem in maintenance hemodialysis patients and guidelines call for nutritional interventions. Serum prealbumin (transthyretin) represents a critical nutritional marker positively correlated with patient survival and negatively correlated with morbidity. Nutritional counseling, oral supplementation as well as intradialytic parenteral nutrition (IDPN) are recommended to fight PEW, however clinical trials on their use are scarce. We conducted a prospective, multicenter, randomized, open-label, controlled, parallel-group Phase IV clinical trial in 107 maintenance hemodialysis patients suffering from PEW to assess the impact of IDPN on prealbumin and other biochemical and clinical parameters reflecting nutritional status. Patients randomized to the intervention group received standardized nutritional counseling plus IDPN three times weekly over 16 weeks followed by a treatment-free period of 12 weeks. The control group received standardized nutritional counseling only. Main trial inclusion criteria included moderate to severe malnutrition (SGA score B or C), maintenance hemodialysis therapy (3 times per week) for more than six months, and presence of two out of the following three criteria: albumin 30 mg/L at week 16 (48.7% vs. 31.8%). Prealbumin response to IDPN therapy was more prominent in patients suffering from moderate malnutrition (SGA score B) compared to patients with severe malnutrition (SGA score C). The results of this trial demonstrate for the first time that IDPN therapy, given three times weekly in a 16-week short-term intervention, results in a statistically significant and clinically relevant increase in mean serum prealbumin, a surrogate marker for outcome and survival in hemodialysis patients suffering from PEW, and is superior to nutritional counseling. Clinical trial registry:www.clinicaltrials.gov (NCT00501956). Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights

  1. Immediate provisionalization in the esthetic zone: 1-year interim results from a prospective single-cohort multicenter study evaluating 3.0-mm-diameter tapered implants.

    Science.gov (United States)

    Kolinski, Martin; Hess, Pablo; Leziy, Sonia; Friberg, Bertil; Bellucci, Gionata; Trisciuoglio, Davide; Wagner, Wilfried; Moergel, Maximilian; Pozzi, Alessandro; Wiltfang, Jörg; Behrens, Eleonore; Zechner, Werner; Vasak, Christoph; Weigl, Paul

    2018-07-01

    The aim of this interim analysis of a 5-year prospective multicenter study is to evaluate clinical and radiological performance of immediately provisionalized 3.0-mm-diameter tapered implants. Patients needing implant rehabilitation of maxillary lateral incisors or mandibular lateral and central incisors were treated with 3.0-mm-diameter implants placed in extraction or healed sites and immediately provisionalized. Clinical and radiographic examinations were performed at implant insertion, 6 months thereafter, and are ongoing. Marginal bone levels and changes, complications, the papilla, plaque, and bleeding indices, and the pink esthetic score (PES) were evaluated at each follow-up visit. Of 112 enrolled patients, 77 patients (91 implants) met the inclusion criteria. Seventy-one patients with 82 implants completed the 1-year follow-up. Three implants failed yielding a CSR of 96.7%. All failures occurred within the first 3 months after implant insertion. Marginal bone level changes from insertion to 6 months was - 0.57 ± 1.30 mm (n = 75) and from insertion to 12 months - 0.25 ± 1.38 mm (n = 72). Fifteen non-serious complications were recorded. Papilla index score and PES improved at the 1-year follow-up. Plaque formation and bleeding-on-probing showed no statistically significant differences between the 6-month and the 1-year visit. This 1-year analysis demonstrated high survival, stable bone levels, and healthy soft tissue with 3.0-mm-diameter implants. Narrow diameter implants are a safe and predictable treatment option in patients with limited bone volume and/or limited interdental space and eligible for immediate loading protocols.

  2. A prospective multicenter study of venous thromboembolism in patients with newly-diagnosed high-grade glioma: hazard rate and risk factors.

    Science.gov (United States)

    Streiff, Michael B; Ye, Xiaobu; Kickler, Thomas S; Desideri, Serena; Jani, Jayesh; Fisher, Joy; Grossman, Stuart A

    2015-09-01

    Venous thromboembolism (VTE) is a common complication in patients with high-grade gliomas. The purpose of this prospective multicenter study was to determine the hazard rate of first symptomatic VTE in newly-diagnosed glioma patients and identify clinical and laboratory risk factors. On enrollment, demographic and clinical information were recorded and a comprehensive coagulation evaluation was performed. Patients were followed until death. The study end point was objectively-documented symptomatic VTE. One hundred seven patients were enrolled with a median age of 57 years (range 29-85) between June 2005 and April 2008. Ninety-one (85 %) had glioblastoma multiforme (GBM). During an average survival of 17.7 months, 26 patients (24 %) (95 % CI 17-34 %) developed VTE (hazard rate 0.15 per person-year) and 94 patients (88 %) died. Median time to VTE was 14.2 weeks post-operation (range 3-126). Patients with an initial tumor biopsy were 3.0 fold more likely to suffer VTE (p = 0.02). Patients with an elevated factor VIII activity (>147 %) were 2.1-fold more likely to develop VTE. ABO blood group, D dimer and thrombin generation were not associated with VTE. No fatal VTE occurred. VTE is a common complication in patients with newly-diagnosed high grade gliomas, particularly in the first six months after diagnosis. Patients with an initial tumor biopsy and elevated factor VIII levels are at increased risk. However, VTE was not judged to be primarily responsible for any patient deaths. Therefore, outpatient primary VTE prophylaxis remains investigational until more effective primary prophylaxis strategies and therapies for glioma are identified.

  3. Helicobacter pylori Primary Antibiotic Resistance in 2015 in Morocco: A Phenotypic and Genotypic Prospective and Multicenter Study.

    Science.gov (United States)

    Bouihat, Najat; Burucoa, Christophe; Benkirane, Ahmed; Seddik, Hassan; Sentissi, Sara; Al Bouzidi, Abderrahmane; Elouennas, Mustapha; Benouda, Amina

    2017-09-01

    Knowledge of local antibiotic resistance is crucial to adaption of the choice of effective empirical first-line treatment for Helicobacter pylori infection. The aim of this study was to evaluate, for the first time in Morocco, the prevalence of the primary resistance of H. pylori to clarithromycin, metronidazole, amoxicillin, levofloxacin, tetracycline, and rifamycin. We conducted a 1-year prospective study (2015), including 255 Moroccan patients referred for gastro-duodenal endoscopy to two hospitals of Rabat (Morocco) and never previously treated for H. pylori infection. Three gastric biopsies were collected: one for histology, one for culture, and one for molecular detection of H. pylori and the mutations in 23S rRNA genes that confer resistance to clarithromycin. Antimicrobial susceptibility testing was performed on isolated strains by Etest and disk diffusion methods. One hundred seventy-seven patients were infected (69.4%). The prevalence of primary resistances of H. pylori to clarithromycin was 29%, 40% to metronidazole, 0% to amoxicillin, tetracycline, and rifamycin, and 11% to levofloxacin. Only four isolates (2%) were resistant to both clarithromycin and metronidazole. The high level of primary clarithromycin resistance in the H. pylori strains infecting the Moroccan population leads us to recommend the abandonment of the standard clarithromycin-based triple therapy as a first-line treatment in Morocco and to prefer a concomitant quadruple therapy.

  4. Does Visual Impairment Affect Social Ties in Late Life? Findings of a Multicenter Prospective Cohort Study in Germany.

    Science.gov (United States)

    Hajek, A; Brettschneider, C; Lühmann, D; Eisele, M; Mamone, S; Wiese, B; Weyerer, S; Werle, J; Pentzek, M; Fuchs, A; Stein, J; Luck, T; Bickel, H; Weeg, D; Heser, K; Jessen, F; Maier, W; Scherer, M; Riedel-Heller, S G; König, H-H

    2017-01-01

    To investigate how visual impairment affects social ties in late life longitudinally. Population-based prospective cohort study. Individuals in old age were recruited via general practitioners' offices (at six study centers) in Germany. They were interviewed every 18 months. Individuals aged 75 years and above at baseline. Follow-up wave 2 (36 months after baseline, n=2,443) and wave 4 (72 months after baseline, n=1,618) were used for the analyses presented here. Social ties were assessed using the 14-item form of the questionnaire for social support (F-SozU K-14). Visual impairment was self-rated on a three level Likert scale (no impairment, mild visual impairment, or severe/profound visual impairment). Adjusting for sociodemographic factors, hearing impairment and comorbidity, fixed effects regressions revealed that the onset of mild visual impairment decreased the social support score, in particular the emotional support score. Additionally, the onset of mild hearing impairment decreased the social support score in men. Moreover, increasing age decreased the social support score in the total sample and in both sexes. Loss of spouse and increasing comorbidity did not affect the social support score. Our results highlight the importance of visual impairment for social ties in late life. Consequently, appropriate strategies in order to delay visual impairment might help to maintain social ties in old age.

  5. Procalcitonin guided antibiotic therapy and hospitalization in patients with lower respiratory tract infections: a prospective, multicenter, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Henzen Christoph

    2007-07-01

    Full Text Available Abstract Background: Lower respiratory tract infections like acute bronchitis, exacerbated chronic obstructive pulmonary disease and community-acquired pneumonia are often unnecessarily treated with antibiotics, mainly because of physicians' difficulties to distinguish viral from bacterial cause and to estimate disease-severity. The goal of this trial is to compare medical outcomes, use of antibiotics and hospital resources in a strategy based on enforced evidence-based guidelines versus procalcitonin guided antibiotic therapy in patients with lower respiratory tract infections. Methods and design: We describe a prospective randomized controlled non-inferiority trial with an open intervention. We aim to randomize over a fixed recruitment period of 18 months a minimal number of 1002 patients from 6 hospitals in Switzerland. Patients must be >18 years of age with a lower respiratory tract infections Discussion: Use of and prolonged exposure to antibiotics in lower respiratory tract infections is high. The proposed trial investigates whether procalcitonin-guidance may safely reduce antibiotic consumption along with reductions in hospitalization costs and antibiotic resistance. It will additionally generate insights for improved prognostic assessment of patients with lower respiratory tract infections. Trial registration: ISRCTN95122877

  6. Risk factors of exocrine and endocrine pancreatic insufficiency after pancreatic resection: A multi-center prospective study.

    Science.gov (United States)

    Maignan, A; Ouaïssi, M; Turrini, O; Regenet, N; Loundou, A; Louis, G; Moutardier, V; Dahan, L; Pirrò, N; Sastre, B; Delpero, J-R; Sielezneff, I

    2018-01-26

    Management of functional consequences after pancreatic resection has become a new therapeutic challenge. The goal of our study is to evaluate the risk factors for exocrine (ExoPI) and endocrine (EndoPI) pancreatic insufficiency after pancreatic surgery and to establish a predictive model for their onset. Between January 1, 2014 and June 19, 2015, 91 consecutive patients undergoing pancreatoduodenectomy (PD) or left pancreatectomy (LP) (72% and 28%, respectively) were followed prospectively. ExoPI was defined as fecal elastase content126mg/dL or aggravation of preexisting diabetes. The volume of residual pancreas was measured according to the same principles as liver volumetry. The ExoPI and EndoPI rates at 6 months were 75.9% and 30.8%, respectively. The rate of ExoPI after PD was statistically significantly higher than after LP (98% vs. 21%; Ppancreatic volume less than 39.5% was predictive of ExoPI. ExoPI occurs quasi-systematically after PD irrespective of the reconstruction scheme. The rate of EndoPI did not differ between PD and LP. Copyright © 2017. Published by Elsevier Masson SAS.

  7. Changes in Rotavirus Genotypes before and after Vaccine Introduction: a Multicenter, Prospective Observational Study in Three Areas of Japan.

    Science.gov (United States)

    Tanaka, Takaaki; Kamiya, Hajime; Asada, Kazutoyo; Suga, Shigeru; Ido, Masaru; Umemoto, Masakazu; Ouchi, Kazunobu; Ito, Hiroaki; Kuroki, Haruo; Nakano, Takashi; Taniguchi, Koki

    2017-07-24

    In Japan, monovalent and pentavalent rotavirus (RV) vaccines were approved in 2011 and 2012, respectively. To monitor changes in the RV genotypes before and after vaccine introduction, we performed a prospective observational study among children (< 5 years) with gastroenteritis who tested RV-positive on antigen rapid tests. Stool samples were collected from 3 different sites in Japan: Tsu City, Mie Prefecture; Kurashiki City, Okayama Prefecture; and Isumi City, Chiba Prefecture. RV genotypes were determined using reverse transcription-polymerase chain reaction. In Tsu City, G3P[8] was dominant (61.0-77.1%) before vaccine introduction, but decreased after introduction. Meanwhile, in an inverse proportion to the decrease in G3P[8], G1P[8] increased until the 2013/14 season, when a sudden predominance of G2P[4] (100%) occurred. A similar trend was observed in Kurashiki City in terms of the extent of reduction in G3P[8] and the emergence of G2P[4]. In Isumi City, G1P[8] was dominant (70.3%) before vaccine introduction, and G9P[8] became predominant (83.3%) in the 2013/14 season. To determine whether the genotype changes are attributable to vaccines or natural epidemiological changes, ongoing continuous monitoring of the RV genotypes is required.

  8. Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

    Directory of Open Access Journals (Sweden)

    Imasawa Toshiyuki

    2012-03-01

    Full Text Available Abstract Background The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD. If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to

  9. Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

    Science.gov (United States)

    Coric, Domagoj; Guyer, Richard D; Nunley, Pierce D; Musante, David; Carmody, Cameron; Gordon, Charles; Lauryssen, Carl; Boltes, Margaret O; Ohnmeiss, Donna D

    2018-03-01

    OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but

  10. Epidemiology of respiratory syncytial virus in children ≤2 years of age hospitalized with lower respiratory tract infections in the Russian Federation: a prospective, multicenter study

    Directory of Open Access Journals (Sweden)

    Vladimir Tatochenko

    2010-09-01

    Full Text Available Vladimir Tatochenko1, Vasily Uchaikin2, Aleksandr Gorelov3, Konstantin Gudkov4, Andrew Campbell5, Gregory Schulz5, Rebecca Prahl5, Gerard Notario51Scientific Centre of Children’s Health, Russian Academy of Medical Sciences, Lomonosovskiy Prospect, Moscow, Russia; 2Russian State Medical University of Roszdrav, Moscow, Russia; 3Central Scientific Research Institution of Epidemiology, Moscow, Russia; 4Abbott Laboratories LLC, Khimki, Moscow, Russia; 5Abbott Laboratories, Abbott Park, IL, USABackground: Respiratory syncytial virus (RSV is the leading cause of severe lower respiratory tract infections among infants and young children, and is responsible for an estimated four million deaths per year globally. A monthly injection of palivizumab has been used for prophylaxis of serious RSV infections among high-risk children in 71 countries since 1998 and approval for use in the Russian Federation was obtained in February 2010. A recommendation for RSV prophylaxis in the Russian Federation would require knowledge of the prevalence and seasonality of RSV in that country.Methods: In a prospective, multicenter, epidemiological study of the prevalence, seasonality, and peak occurrence of RSV infection, children aged ≤2 years hospitalized for lower respiratory tract infections in three regions of the Russian Federation, from September 2008 through April 2009, were screened and tested for RSV using rapid immunochromatography of nasopharyngeal lavage. For subjects who were tested positive, hospitalization data were collected.Results: Of 519 children aged ≤2 years enrolled from September 11, 2008 through April 26, 2009, 197 tested positive for RSV (38.0%, 95% CI: 33.8, 42.3. The onset of the 2008–2009 RSV season in the Russian Federation occurred in late October 2008, similar to what is observed in other northern temperate zones. Peak activity occurred in early April 2009, when 62% of children enrolled tested positive for RSV.Conclusion: The prevalence

  11. African American community members sustain favorable blood pressure outcomes through 12-month telephone motivational interviewing (MI) maintenance

    Science.gov (United States)

    Community approaches offer promise for addressing disparities experienced by African Americans in hypertension prevalence, treatment, and control. HUB City Steps, a community-based participatory research lifestyle intervention, tracked participants through a 12-month MI maintenance phase following a...

  12. Comparison of F(ab')2 versus Fab antivenom for pit viper envenomation: a prospective, blinded, multicenter, randomized clinical trial.

    Science.gov (United States)

    Bush, Sean P; Ruha, Anne-Michelle; Seifert, Steven A; Morgan, David L; Lewis, Brandon J; Arnold, Thomas C; Clark, Richard F; Meggs, William J; Toschlog, Eric A; Borron, Stephen W; Figge, Gary R; Sollee, Dawn R; Shirazi, Farshad M; Wolk, Robert; de Chazal, Ives; Quan, Dan; García-Ubbelohde, Walter; Alagón, Alejandro; Gerkin, Richard D; Boyer, Leslie V

    2015-01-01

    Crotalidae Polyvalent Immune Fab (Ovine) has been the only antivenom commercially available in the US since 2007 for treatment of Crotalinae envenomation. Late coagulopathy can occur or recur after clearance of Fab antivenom, often after hospital discharge, lasting in some cases more than 2 weeks. There have been serious, even fatal, bleeding complications associated with recurrence phenomena. Frequent follow-up is required, and additional intervention or hospitalization is often necessary. F(ab')2 immunoglobulin derivatives have longer plasma half life than do Fab. We hypothesized that F(ab')2 antivenom would be superior to Fab in the prevention of late coagulopathy following treatment of patients with Crotalinae envenomation. We conducted a prospective, double-blind, randomized clinical trial, comparing late coagulopathy in snakebitten patients treated with F(ab')2 with maintenance doses [F(ab')2/F(ab')2], or F(ab')2 with placebo maintenance doses [F(ab')2/placebo], versus Fab with maintenance doses [Fab/Fab]. The primary efficacy endpoint was coagulopathy (platelet count Fab/Fab cohort experienced late coagulopathy versus 4/39 (10.3%, p < 0.05) in the F(ab')2/F(ab')2 cohort and 2/38 (5.3%, p < 0.05) in the F(ab')2/placebo cohort. The lowest heterologous protein exposure was with F(ab')2/placebo. No serious adverse events were related to study drug. In each study arm, one patient experienced an acute serum reaction and one experienced serum sickness. In this study, management of coagulopathic Crotalinae envenomation with longer-half-life F(ab')2 antivenom, with or without maintenance dosing, reduced the risk of subacute coagulopathy and bleeding following treatment of envenomation.

  13. EUS-guided rendezvous for difficult biliary cannulation using a standardized algorithm: a multicenter prospective pilot study (with videos).

    Science.gov (United States)

    Iwashita, Takuji; Yasuda, Ichiro; Mukai, Tsuyoshi; Iwata, Keisuke; Ando, Nobuhiro; Doi, Shinpei; Nakashima, Masanori; Uemura, Shinya; Mabuchi, Masatoshi; Shimizu, Masahito

    2016-02-01

    Biliary cannulation is necessary in therapeutic ERCP for biliary disorders. EUS-guided rendezvous (EUS-RV) can salvage failed cannulation. Our aim was to determine the safety and efficacy of EUS-RV by using a standardized algorithm with regard to the endoscope position in a prospective study. EUS-RV was attempted after failed cannulation in 20 patients. In a standardized approach, extrahepatic bile duct (EHBD) cannulation was preferentially attempted from the second portion of the duodenum (D2) followed by additional approaches to the EHBD from the duodenal bulb (D1) or to the intrahepatic bile duct from the stomach, if necessary. A guidewire was placed in an antegrade fashion into the duodenum. After the guidewire was placed, the endoscope was exchanged for a duodenoscope to complete the cannulation. The bile duct was accessed from the D2 in 10 patients, but from the D1 in 5 patients and the stomach in 4 patients because of no dilation or tumor invasion at the distal EHBD. In the remaining patient, biliary puncture was not attempted due to the presence of collateral vessels. The guidewire was successfully manipulated in 80% of patients: 100% (10/10) with the D2 approach and 66.7% (6/9) with other approaches. The overall success rate was 80% (16/20). Failed EUS-RV was salvaged with a percutaneous approach in 2 patients, repeat ERCP in 1 patient, and conservative management in 1 patient. Minor adverse events occurred in 15% of patients (3/20). EUS-RV is a safe and effective salvage method. Using EUS-RV to approach the EHBD from the D2 may improve success rates. Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  14. Brachytherapy versus prostatectomy in localized prostate cancer: Results of a French multicenter prospective medico-economic study

    International Nuclear Information System (INIS)

    Buron, Catherine; Le Vu, Beatrice; Cosset, Jean-Marc; Pommier, Pascal; Peiffert, Didier; Delannes, Martine; Flam, Thierry; Guerif, Stephane; Salem, Naji; Chauveinc, Laurent; Livartowski, Alain

    2007-01-01

    Purpose: To prospectively compare health-related quality of life (HRQOL), patient-reported treatment-related symptoms, and costs of iodine-125 permanent implant interstitial brachytherapy (IB) with those of radical prostatectomy (RP) during the first 2 years after these treatments for localized prostate cancer. Methods and Materials: A total of 435 men with localized low-risk prostate cancer, from 11 French hospitals, treated with IB (308) or RP (127), were offered to complete the European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire QLQ-C30 version 3 (EORTC QLQ-C30) and the prostate cancer specific EORTC QLQ-PR25 module before and at the end of treatment, 2, 6, 12, 18, and 24 months after treatment. Repeated measures analysis of variance and analysis of covariance were conducted on HRQOL changes. Comparative cost analysis covered initial treatment, hospital follow-up, outpatient and production loss costs. Results: Just after treatment, the decrease of global HRQOL was less pronounced in the IB than in the RP group, with a 13.5 points difference (p < 0.0001). A difference slightly in favor of RP was observed 6 months after treatment (-7.5 points, p = 0.0164) and was maintained at 24 months (-8.2 points, p = 0.0379). Impotence and urinary incontinence were more pronounced after RP, whereas urinary frequency, urgency, and urination pain were more frequent after IB. Mean societal costs did not differ between IB ( Euro 8,019 at T24) and RP ( Euro 8,715 at T24, p = 0.0843) regardless of the period. Conclusions: This study suggests a similar cost profile in France for IB and RP but with different HRQOL and side effect profiles. Those findings may be used to tailor localized prostate cancer treatments to suit individual patients' needs

  15. Early and 1-year outcomes of aortic root surgery in patients with Marfan syndrome: a prospective, multicenter, comparative study.

    Science.gov (United States)

    Coselli, Joseph S; Volguina, Irina V; LeMaire, Scott A; Sundt, Thoralf M; Connolly, Heidi M; Stephens, Elizabeth H; Schaff, Hartzell V; Milewicz, Dianna M; Vricella, Luca A; Dietz, Harry C; Minard, Charles G; Miller, D Craig

    2014-06-01

    To compare the 1-year results after aortic valve-sparing (AVS) or valve-replacing (AVR) aortic root replacement from a prospective, international registry of 316 patients with Marfan syndrome (MFS). Patients underwent AVS (n = 239, 76%) or AVR (n = 77, 24%) aortic root replacement at 19 participating centers from 2005 to 2010. One-year follow-up data were complete for 312 patients (99%), with imaging findings available for 293 (94%). The time-to-events were compared between groups using Kaplan-Meier curves and Cox proportional hazards models. Two patients (0.6%)--1 in each group--died within 30 days. No significant differences were found in early major adverse valve-related events (MAVRE; P = .6). Two AVS patients required early reoperation for coronary artery complications. The 1-year survival rates were similar in the AVR (97%) and AVS (98%) groups; the procedure type was not significantly associated with any valve-related events. At 1 year and beyond, aortic regurgitation of at least moderate severity (≥2+) was present in 16 patients in the AVS group (7%) but in no patients in the AVR group (P = .02). One AVS patient required late AVR. AVS aortic root replacement was not associated with greater 30-day mortality or morbidity rates than AVR root replacement. At 1 year, no differences were found in survival, valve-related morbidity, or MAVRE between the AVS and AVR groups. Of concern, 7% of AVS patients developed grade ≥2+ aortic regurgitation, emphasizing the importance of 5 to 10 years of follow-up to learn the long-term durability of AVS versus AVR root replacement in patients with MFS. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  16. The application of the Ten Group classification system (TGCS in caesarean delivery case mix adjustment. A multicenter prospective study.

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    Gianpaolo Maso

    Full Text Available BACKGROUND: Caesarean delivery (CD rates are commonly used as an indicator of quality in obstetric care and risk adjustment evaluation is recommended to assess inter-institutional variations. The aim of this study was to evaluate whether the Ten Group classification system (TGCS can be used in case-mix adjustment. METHODS: Standardized data on 15,255 deliveries from 11 different regional centers were prospectively collected. Crude Risk Ratios of CDs were calculated for each center. Two multiple logistic regression models were herein considered by using: Model 1- maternal (age, Body Mass Index, obstetric variables (gestational age, fetal presentation, single or multiple, previous scar, parity, neonatal birth weight and presence of risk factors; Model 2- TGCS either with or without maternal characteristics and presence of risk factors. Receiver Operating Characteristic (ROC curves of the multivariate logistic regression analyses were used to assess the diagnostic accuracy of each model. The null hypothesis that Areas under ROC Curve (AUC were not different from each other was verified with a Chi Square test and post hoc pairwise comparisons by using a Bonferroni correction. RESULTS: Crude evaluation of CD rates showed all centers had significantly higher Risk Ratios than the referent. Both multiple logistic regression models reduced these variations. However the two methods ranked institutions differently: model 1 and model 2 (adjusted for TGCS identified respectively nine and eight centers with significantly higher CD rates than the referent with slightly different AUCs (0.8758 and 0.8929 respectively. In the adjusted model for TGCS and maternal characteristics/presence of risk factors, three centers had CD rates similar to the referent with the best AUC (0.9024. CONCLUSIONS: The TGCS might be considered as a reliable variable to adjust CD rates. The addition of maternal characteristics and risk factors to TGCS substantially increase the

  17. Data-driven Development of ROTEM and TEG Algorithms for the Management of Trauma Hemorrhage: A Prospective Observational Multicenter Study.

    Science.gov (United States)

    Baksaas-Aasen, Kjersti; Van Dieren, Susan; Balvers, Kirsten; Juffermans, Nicole P; Næss, Pål A; Rourke, Claire; Eaglestone, Simon; Ostrowski, Sisse R; Stensballe, Jakob; Stanworth, Simon; Maegele, Marc; Goslings, Carel; Johansson, Pär I; Brohi, Karim; Gaarder, Christine

    2018-05-23

    Developing pragmatic data-driven algorithms for management of trauma induced coagulopathy (TIC) during trauma hemorrhage for viscoelastic hemostatic assays (VHAs). Admission data from conventional coagulation tests (CCT), rotational thrombelastometry (ROTEM) and thrombelastography (TEG) were collected prospectively at 6 European trauma centers during 2008 to 2013. To identify significant VHA parameters capable of detecting TIC (defined as INR > 1.2), hypofibrinogenemia (< 2.0 g/L), and thrombocytopenia (< 100 x10/L), univariate regression models were constructed. Area under the curve (AUC) was calculated, and threshold values for TEG and ROTEM parameters with 70% sensitivity were included in the algorithms. A total of, 2287 adult trauma patients (ROTEM: 2019 and TEG: 968) were enrolled. FIBTEM clot amplitude at 5 minutes (CA5) had the largest AUC and 10 mm detected hypofibrinogenemia with 70% sensitivity. The corresponding value for functional fibrinogen (FF) TEG maximum amplitude (MA) was 19 mm. Thrombocytopenia was similarly detected using the calculated threshold EXTEM-FIBTEM CA5 30 mm. The corresponding rTEG-FF TEG MA was 46 mm. TIC was identified by EXTEM CA5 41 mm, rTEG MA 64 mm (80% sensitivity). For hyperfibrinolysis, we examined the relationship between viscoelastic lysis parameters and clinical outcomes, with resulting threshold values of 85% for EXTEM Li30 and 10% for rTEG Ly30.Based on these analyses, we constructed algorithms for ROTEM, TEG, and CCTs to be used in addition to ratio driven transfusion and tranexamic acid. We describe a systematic approach to define threshold parameters for ROTEM and TEG. These parameters were incorporated into algorithms to support data-driven adjustments of resuscitation with therapeutics, to optimize damage control resuscitation practice in trauma.

  18. Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ricke, Jens, E-mail: jens.ricke@med.ovgu.de; Jürgens, Julian H. W., E-mail: julian.juergens@med.ovgu.de [University of Magdeburg, Department of Radiology and Nuclear Medicine (Germany); Deschamps, Frederic; Tselikas, Lambros [Institut de Cancérologie Gustave Roussy, Department of Image Guided Therapy (France); Uhde, Katja; Kosiek, Ortrud [University of Magdeburg, Department of Radiology and Nuclear Medicine (Germany); Baere, Thierry De [Institut de Cancérologie Gustave Roussy, Department of Image Guided Therapy (France)

    2015-04-15

    PurposeTo assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.Materials and MethodsPatients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife{sup ®} (Angiodynamics). System settings for the ablation procedure followed the manufacturer’s recommendations. The Mann–Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up was 12 months.ResultsThe expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8–27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).ConclusionsIRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.

  19. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation.

    Science.gov (United States)

    Hsieh, Yu-Hsi; Tseng, Chih-Wei; Hu, Chi-Tan; Koo, Malcolm; Leung, Felix W

    2017-07-01

    Adenoma detection rate (ADR), defined as the proportion of patients with at least one adenoma of any size, is a quality indicator. We tested the hypothesis that water exchange (WE) improves ADR but water immersion (WI) has no adverse effect on ADR compared with air insufflation (AI). A prospective study was conducted at the Dalin Tzu Chi Hospital in southern Taiwan and the Hualien Tzu Chi Hospital in eastern Taiwan on patients randomly assigned to WE, WI, or AI with stratification by the 3 study colonoscopists. The primary outcome was ADR. From July 2013 to December 2015, 651 patients were recruited and randomized into 3 groups with a 1:1:1 ratio (217 patients per group). Overall, ADR met quality standards: WE 49.8% (95% CI, 43.2%-56.4%), AI 37.8% (95% CI, 31.6%-44.4%), and WI 40.6% (95% CI, 34.2%-47.2%). Compared with AI, WE significantly increased ADR (P = .016). There was no difference between WI and WE. ADRs of WI and AI were comparable. Compared with AI, WE confirmed a longer insertion time, higher cleanliness score, but similar adenoma per positive colonoscopy (APPC) and withdrawal time with polypectomy. Subgroup analysis found WE significantly increased ADR in propofol-sedated patients. Multivariate generalized linear mixed model analysis revealed that age ≥50 years, WE (vs AI), colonoscopy indication, no previous history of colonoscopy, and withdrawal time >8 minutes were significant predictors of increased ADR. Confirmation of prior reports showing WE, but not WI, increased ADR further strengthened the validity of our observations. WE significantly increased ADR in propofol-sedated patients. The outcome differences justify assessment of the role of WE in colorectal cancer prevention. Similar APPC and withdrawal times suggest that adequate inspection was performed on colonoscope withdrawal in each of the study arms. (Clinical trial registration number: NCT01894191.). Copyright © 2017 American Society for Gastrointestinal Endoscopy. All rights reserved.

  20. A Multicenter Prospective Validation Study for the Korean Thyroid Imaging Reporting and Data System in Patients with Thyroid Nodules

    Energy Technology Data Exchange (ETDEWEB)

    Ha, Eun Ju [Department of Radiology, Ajou University School of Medicine, Suwon 16499 (Korea, Republic of); Moon, Won-Jin [Department of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul 05030 (Korea, Republic of); Na, Dong Gyu [Department of Radiology, Human Medical Imaging and Intervention Center, Seoul 06524 (Korea, Republic of); Lee, Young Hen [Department of Radiology, Ansan Hospital, Korea University School of Medicine, Ansan 15355 (Korea, Republic of); Choi, Nami [Department of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul 05030 (Korea, Republic of); Kim, Soo Jin [Department of Radiology, Human Medical Imaging and Intervention Center, Seoul 06524 (Korea, Republic of); Department of Radiology, New Korea Hospital, Gimpo 10086 (Korea, Republic of); Kim, Jae Kyun [Department of Radiology, Chung-Ang University Hospital, Seoul 06973 (Korea, Republic of)

    2016-11-01

    To validate a new risk stratification system for thyroid nodules, the Korean Thyroid Imaging Reporting and Data System (K-TIRADS), using a prospective design. From June 2013 to May 2015, 902 thyroid nodules were enrolled from four institutions. The type and predictive value of ultrasonography (US) predictors were analyzed according to the combination of the solidity and echogenicity of nodules; in addition, we determined malignancy risk and diagnostic performance for each category of K-TIRADS, and compared the efficacy of fine-needle aspiration (FNA) with a three-tier risk categorization system published in 2011. The malignancy risk was significantly higher in solid hypoechoic nodules, as compared to partially cystic or isohyperechoic nodules (each p < 0.001). The presence of any suspicious US features had a significantly higher malignancy risk (73.4%) in solid hypoechoic nodules than in partially cystic or isohyperechoic nodules (4.3–38.5%; p < 0.001). The calculated malignancy risk in K-TIRADS categories 5, 4, 3, and 2 nodules were 73.4, 19.0, 3.5, and 0.0%, respectively; and the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for malignancy were 95.5, 58.6, 44.5, 96.9, and 69.5%, respectively, in K-TIRADS categories 4 and 5. The efficacy of FNA for detecting malignancy based on K-TIRADS was increased from 18.6% (101/544) to 22.5% (101/449), as compared with the three-tier risk categorization system (p < 0.001). The proposed new risk stratification system based on solidity and echogenicity was useful for risk stratification of thyroid nodules and the decision for FNA. The malignancy risk of K-TIRADS was in agreement with the findings of a previous retrospective study.

  1. A multicenter prospective validation study for the Korea thyroid imaging reporting and data system in patients with thyroid nodules

    Energy Technology Data Exchange (ETDEWEB)

    Ha, Eun Ju [Dept. of Radiology, Ajou University School of Medicine, Suwon (Korea, Republic of); Moon, Won Jin; Choi, Nami [Dept. of Radiology, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul (Korea, Republic of); Na, Dong Gyu; Kim, Soo Jin [Dept. of Radiology, Human Medical Imaging and Intervention Center, Seoul (Korea, Republic of); Lee, Young Hen [Dept. of Radiology, Ansan Hospital, Korea University School of Medicine, Ansan (Korea, Republic of); Kim, Jae Kyun [Dept. of Radiology, Chung-Ang University Hospital, Seoul (Korea, Republic of)

    2016-09-15

    To validate a new risk stratification system for thyroid nodules, the Korean Thyroid Imaging Reporting and Data System (K-TIRADS), using a prospective design. From June 2013 to May 2015, 902 thyroid nodules were enrolled from four institutions. The type and predictive value of ultrasonography (US) predictors were analyzed according to the combination of the solidity and echogenicity of nodules; in addition, we determined malignancy risk and diagnostic performance for each category of K-TIRADS, and compared the efficacy of fine-needle aspiration (FNA) with a three-tier risk categorization system published in 2011. The malignancy risk was significantly higher in solid hypoechoic nodules, as compared to partially cystic or isohyperechoic nodules (each p < 0.001). The presence of any suspicious US features had a significantly higher malignancy risk (73.4%) in solid hypoechoic nodules than in partially cystic or isohyperechoic nodules (4.3–38.5%; p < 0.001). The calculated malignancy risk in K-TIRADS categories 5, 4, 3, and 2 nodules were 73.4, 19.0, 3.5, and 0.0%, respectively; and the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for malignancy were 95.5, 58.6, 44.5, 96.9, and 69.5%, respectively, in K-TIRADS categories 4 and 5. The efficacy of FNA for detecting malignancy based on K-TIRADS was increased from 18.6% (101/544) to 22.5% (101/449), as compared with the three-tier risk categorization system (p < 0.001). The proposed new risk stratification system based on solidity and echogenicity was useful for risk stratification of thyroid nodules and the decision for FNA. The malignancy risk of K-TIRADS was in agreement with the findings of a previous retrospective study.

  2. Comprehensive Nutritional and Dietary Intervention for Autism Spectrum Disorder—A Randomized, Controlled 12-Month Trial

    Directory of Open Access Journals (Sweden)

    James B. Adams

    2018-03-01

    Full Text Available This study involved a randomized, controlled, single-blind 12-month treatment study of a comprehensive nutritional and dietary intervention. Participants were 67 children and adults with autism spectrum disorder (ASD ages 3–58 years from Arizona and 50 non-sibling neurotypical controls of similar age and gender. Treatment began with a special vitamin/mineral supplement, and additional treatments were added sequentially, including essential fatty acids, Epsom salt baths, carnitine, digestive enzymes, and a healthy gluten-free, casein-free, soy-free (HGCSF diet. There was a significant improvement in nonverbal intellectual ability in the treatment group compared to the non-treatment group (+6.7 ± 11 IQ points vs. −0.6 ± 11 IQ points, p = 0.009 based on a blinded clinical assessment. Based on semi-blinded assessment, the treatment group, compared to the non-treatment group, had significantly greater improvement in autism symptoms and developmental age. The treatment group had significantly greater increases in EPA, DHA, carnitine, and vitamins A, B2, B5, B6, B12, folic acid, and Coenzyme Q10. The positive results of this study suggest that a comprehensive nutritional and dietary intervention is effective at improving nutritional status, non-verbal IQ, autism symptoms, and other symptoms in most individuals with ASD. Parents reported that the vitamin/mineral supplements, essential fatty acids, and HGCSF diet were the most beneficial.

  3. Physical activity in Iranian older adults who experienced fall during the past 12 months.

    Science.gov (United States)

    Salehi, Leili; Shokrvash, Behjat; Jamshidi, Ensiyeh; Montazeri, Ali

    2014-10-31

    Physical activity may have several benefits for elderly people. However, the risk of falling might prevent this population from showing interest in physical activity. This research was aimed to explore facilitators and barriers to physical activity in older persons who have experienced at least one fall in the past 12 months. This cross sectional study was conducted in 2010-2011, in Tehran, Iran. Using a multistage sampling method a group of elderly people entered into the study. A multi-section questionnaire was used to collect data on demographic information, physical activity level, and different determinants that might influence physical activity. Several statistical tests including linear regression were used to analyze the data. In all, 180 old people from 40 elderly centers (49 men and 131 women) took part in the study. The mean age of participants was 65.9 ± 6.1 years. The result indicated that most participants experienced two or more falls during the last year (54.5%). Those who had more falls significantly scored lower on the Physical Activity Scale for Elderly (p falls, self-reported health and daily living activities. However, we observed inverse association between number of falls and physical activity. Indeed the findings suggest that we should reinforce benefits exist when designing programs to increase physical activity among elderly population.

  4. Fine Motor Development of Low Birth Weight Infants Corrected Aged 8 to 12 Months

    Directory of Open Access Journals (Sweden)

    Sepideh Nazi

    2012-10-01

    Full Text Available Objectives: The aim of this study was to compare the fine motor development between Low Birth Weight (LBW infants and Normal Birth Weight infants (NBW at the age of 8-12 months by using the Peabody Developmental Motor Scale-2 (PDMS-2 . Methods: This was a non experimental and cross sectional study which was conducted on the 18 LBW infants and 14 normal infants. By referring to the profile of infants in NICU of Aliasghar Hospital, those with defined inclusion criteria was recognized (case group. The normal weight infants, randomly selected from Health Center of that hospital, matched with case group for date of birth. After completing the questionnaire about demographic variables, their gross motor development was assessed with PDMS-2. Finally the scores of the motor quotient were analyzed by independent t-test statistical method. Results: There was a significant difference between Fine motor quotient of groups (P=0.007. Discussion: This study showed that LBW infants are significantly lower than normal weight infants in attaining Fine motor skills. It means that the LBW infants are more prone to developmental difficulties.

  5. Cerebral ultrasound in newborns with severs asphyxia: correlation with the neurological status at 12 months

    International Nuclear Information System (INIS)

    Esparza, J.; Gonzalez, A.; Inchusta, M.I.; Pina, L.

    1997-01-01

    To establish the prognostic value of cerebral ultrasound performed in newborns (NB) with severe asphyxia. A retrospective study of the ultrasound (US) findings during the acute phase of severe perinatal asphyxia was carried out in a series of 182 NB. The US images were correlated with the neurological status of the infants at the age of 12 months. Of the 122 NB with normal US findings, 94,2% presented no sequelae or a slightly impaired psychomotor performance attributable to prematurity, thus conferring a high prognostic value to this technique. Subependymal cerebral hemorrhage was diagnosed in 35 cases (22 grades I and II, 9 grade III and 4 grade IV), in whom the prognosis was related to the grade of hemorrhage. Twenty-five NB were diagnosed as having some type of hypoxic or ischemic encephalopathy, eith the prognosis differing according to the topography of the lesion and the reversibility of the ultrasonographic signs: poor prognosis in ten NB with diffuse cerebral involvement and in four with periventricular leukomalacia, uncertain prognosis in seven NB with focal brain damage and a good prognosis in four with reversible cerebral edema. (Author) 35 refs

  6. Atypical social development in neonatal intensive care unit survivors at 12 months.

    Science.gov (United States)

    Yamada, Yasumasa; Yoshida, Futoshi; Hemmi, Hayato; Ito, Miharu; Kakita, Hiroki; Yoshikawa, Toru; Hishida, Manabu; Iguchi, Toshiyuki; Seo, Tomoko; Nakanishi, Keiko

    2011-12-01

    Owing to advances in neonatal intensive care, many infants who are hospitalized in neonatal intensive care units (NICU) can survive and grow, and are referred to as NICU survivors. However, social development in NICU survivors has not been fully explored. To examine the social development of NICU survivors, a questionnaire consisting of the Modified Checklist for Autism in Toddlers (M-CHAT) was used. The M-CHAT was completed by the parents of either NICU survivors (n= 117) or normally delivered children (control group, n= 112) during their regular medical checkups at a corrected age of 12 months. Ninety percent of NICU survivors and 63% of control children did not pass the M-CHAT screen. As it was originally designed for children aged 18-30 months, failed M-CHAT items could have been due to developmental issues and not due to autistic spectrum disorders. However, there was a significant difference in the total number of items failed between the two groups. In particular, many NICU survivors did not pass on M-CHAT items, such as oversensitivity to noise, unusual finger movements, and attempts to attract attention. Concerning perinatal complications, infants with low birthweight and/or the need for respiratory support tended to have a higher number of failures on all M-CHAT items. NICU survivors may have distinct developmental patterns of social communication, and should be followed up for assessment of social skills and neurological development. © 2011 The Authors. Pediatrics International © 2011 Japan Pediatric Society.

  7. The role of verbal labels on flexible memory retrieval at 12-months of age.

    Science.gov (United States)

    Taylor, Gemma; Liu, Hao; Herbert, Jane S

    2016-11-01

    The provision of verbal labels enhances 12-month-old infants' memory flexibility across a form change in a puppet imitation task (Herbert, 2011), although the mechanisms for this effect remain unclear. Here we investigate whether verbal labels can scaffold flexible memory retrieval when task difficulty increases and consider the mechanism responsible for the effect of language cues on early memory flexibility. Twelve-month-old infants were provided with English, Chinese, or empty language cues during a difficult imitation task, a combined change in the puppet's colour and form at the test (Hayne et al., 1997). Imitation performance by infants in the English language condition only exceeded baseline performance after the 10-min delay. Thus, verbal labels facilitated flexible memory retrieval on this task. There were no correlations between infants' language comprehension and imitation performance. Thus, it is likely that verbal labels facilitate both attention and categorisation during encoding and retrieval. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  8. Assessment of Gastroesophageal Reflux in Children(2-12 Month Based on Clinical Findings and Ultrasonography

    Directory of Open Access Journals (Sweden)

    F Jassemi Zergani

    2012-07-01

    Full Text Available Introduction: Gastroesophageal reflux is a common gastrointestinal disorder among infants, which can cause complications, such as esophagitis and Barrett's esophagus if its diagnosis and treatment are delayed. On the other hand, similarity of Gastro esophageal Reflux symptoms with symptoms of other childhood diseases makes its diagnosis and treatment difficult. So a proper tool for early screening and diagnostic test is essential. Methods: This study was conducted on 221 infants(2 to 12 months with initial symptoms of gastro esophageal reflux(frequent vomiting, restlessness after feeding, no weight gain, coughing repeatedly and refusing to eat that referred to pediatric Clinic of Rajai Hospital in Tonekabon. Data was collected with demographic and infant gastro esophageal reflux questionnaire by use of the information in records and interview with parents. Then the samples were examined via sonography for gastroesophagial reflux. Results: After initial screening based on infants gastro esophageal reflux tool, gastro esophageal reflux by ultrasound was positive in 63/3% of infants. The mean esophageal diameter was (20/73±2/54mm in infants with gastro esophageal reflux and (23/71±2/35mm in infants without gastro esophageal reflux. Conclusion: Due to the similarity of gastro esophageal Reflux symptoms with clinical symptoms of other childhood diseases, use of an initial screening measurement for early assessment of gastro esophageal reflux in infants is necessary. Moreover, appropriate, available and low costs diagnostic method with little complication seems essential such as ultrasonography for confirm diagnosis and early treatment.

  9. Handgrip strength is associated with, but poorly predicts, disability in older women with acute low back pain: A 12-month follow-up study.

    Science.gov (United States)

    Felício, Diogo Carvalho; Diz, Juliano Bergamaschine Mata; Pereira, Daniele Sirineu; Queiroz, Bárbara Zille de; Silva, Juscélio Pereira de; Moreira, Bruno de Souza; Oliveira, Vinícius Cunha; Pereira, Leani Souza Máximo

    2017-10-01

    Older women with low back pain (LBP) constitute a special subpopulation at risk of severe and permanent disability. It is important to identify factors limiting functionality in this population in order to reduce costs and improve both prevention and intervention. Handgrip strength (HGS) is a biomarker of aging associated with several adverse health outcomes, but long-term associations with disability in older patients with LBP are not known. To examine whether HGS predicts disability in older women with acute low back pain (LBP). Longitudinal analyses were conducted with a sample of 135 older women from the international multicenter study Back Complaints in the Elders (BACE-Brazil). Women aged 60 years and over with a new episode of acute LBP were included. HGS was assessed with Jamar ® dynamometer, and disability was assessed using the Roland Morris questionnaire and gait speed test. Variables were assessed at baseline and at 12-month follow-up. Linear regression models explored associations between HGS and disability measures. Significant association was found between HGS at baseline and gait speed at 12-month follow-up (r=-0.24; p=0.004). A multivariable-adjusted model showed that this association was independent of age, body mass index, and pain intensity (adjusted R 2 =0.13; pinclusion of HGS as an independent variable. No association was found between HGS and score on the Roland Morris questionnaire. Caution is needed regarding the use of HGS as a predictive measure of disability in older women with acute LBP. Changes in gait speed were very small and unlikely to be of clinical relevance. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Relationships between Breastfeeding Patterns and Maternal and Infant Body Composition over the First 12 Months of Lactation

    OpenAIRE

    Zoya Gridneva; Alethea Rea; Anna R. Hepworth; Leigh C. Ward; Ching T. Lai; Peter E. Hartmann; Donna T. Geddes

    2018-01-01

    Breastfeeding has been implicated in the establishment of infant appetite regulation, feeding patterns and body composition (BC). A holistic approach is required to elucidate relationships between infant and maternal BC and contributing factors, such as breastfeeding parameters. Associations between maternal and breastfed term infant BC (n = 20) and feeding parameters during first 12 months of lactation were investigated. BC was measured at 2, 5, 9 and/or 12 months postpartum with ultrasound ...

  11. Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

    Science.gov (United States)

    Harris, David M.; Nicholson, Dawn M.; McCarthy, Delwin; Yukna, Raymond A.; Reynolds, Mark A.; Greenwell, Henry; Finley, James; McCawley, Thomas K.; Xenoudi, Pinelopi; Gregg, Robert H.

    2014-02-01

    Data are presented from a multi-center, prospective, longitudinal, clinical trial comparing four different treatments for periodontitis, (1) the LANAPTM protocol utilizing a FR pulsed-Nd:YAG laser; (2) flap surgery using the Modified Widman technique (MWF); (3) traditional scaling and root planing (SRP); and (4) coronal debridement (CD). Each treatment was randomized to a different quadrant. Fifty-one (54) subjects were recruited at five centers that included both private practice and university-based investigators. At 6-months and 12 months post-treatment the LANAPTM protocol and MWF yielded equivalent results based on changes in probing depths. The major difference observed between the two procedures was that patients reported significantly greater comfort following the LANAP™ procedure than following the MWF (P<0.001). There was greater reduction in bleeding in the LANAPTM quadrant than in the other three at both 6 and 12 months. Improvements following SRP were better than expected at 6 months and continued to improve, providing outcomes that were equivalent to both LANAPTM and MWF at 12 months. The improvement in the SRP quadrants suggests the hypothesis that an aspect of the LANAPTM protocol generated a significant, positive and unanticipated systemic (or trans-oral) effect on sub-gingival wound healing.

  12. A multicenter prospective study of neonatal outcomes at less than 32 weeks associated with indications for maternal admission and delivery.

    Science.gov (United States)

    Garite, Thomas J; Combs, C Andrew; Maurel, Kimberly; Das, Anita; Huls, Kevin; Porreco, Richard; Reisner, Dale; Lu, George; Bush, Melissa; Morris, Bruce; Bleich, April

    2017-07-01

    Counseling for patients with impending premature delivery traditionally has been based primarily on the projected gestational age at delivery. There are limited data regarding how the indications for the preterm birth affect the neonatal outcome and whether this issue should be taken into account in decisions regarding management and patient counseling. We performed a prospective study of pregnancies resulting in premature delivery at less than 32 weeks to determine the influence of both the indications for admission and their associated indications for delivery on neonatal mortality and complications of prematurity. This is a multicenter, prospective study in 10 hospitals where all data from the neonatal intensive care unit routinely was imported to a deidentified data warehouse. Maternal data were collected prospectively at or near the time of delivery. Eligible subjects included singleton deliveries in these hospitals between 23 0/7 and 31 6/7 weeks. The primary hypothesis of the study was to determine whether there was a difference in the primary outcome, which was defined as neonatal composite morbidity, between those neonates delivered after admission for premature labor vs premature rupture of membranes, because these were expected to be the 2 most frequent diagnoses leading to premature birth. The sample size was calculated based on a 10% difference in outcomes for these 2 entities. We based this hypothesis on the knowledge that premature rupture of membranes has a greater incidence of intra-amniotic infection and inflammation than premature labor and that outcomes for premature neonates are worse when delivery is associated with intra-amniotic infection. Additional outcomes were analyzed for all other indications for admission and delivery. Composite morbidity was defined as ≥1 of the following: respiratory distress syndrome (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (requirement for oxygen

  13. Role of major resection in pulmonary metastasectomy for colorectal cancer in the Spanish prospective multicenter study (GECMP-CCR).

    Science.gov (United States)

    Hernández, J; Molins, L; Fibla, J J; Heras, F; Embún, R; Rivas, J J

    2016-05-01

    Patients with pulmonary metastases from colorectal cancer (CRC) may benefit from aggressive surgical therapy. The objective of this study was to determine the role of major anatomic resection for pulmonary metastasectomy to improve survival when compared with limited pulmonary resection. Data of 522 patients (64.2% men, mean age 64.5 years) who underwent pulmonary resections with curative intent for CRC metastases over a 2-year period were reviewed. All patients were followed for a minimum of 3 years. Disease-specific survival (DSS) and disease-free survival (DFS) were assessed with the Kaplan-Meier method. Factors associated with DSS and DFS were analyzed using a Cox proportional hazards regression model. A total of 394 (75.6%) patients underwent wedge resection, 19 (3.6%) anatomic segmentectomy, 5 (0.9%) lesser resections not described, 100 (19.3%) lobectomy, and 4 (0.8%) pneumonectomy. Accordingly, 104 (19.9%) patients were treated with major anatomic resection and 418 (80.1%) with lesser resection. Operations were carried out with video-assisted thoracoscopic surgery (VATS) in 93 patients. The overall DSS and DFS were 55 and 28.3 months, respectively. Significant differences in DSS and DFS in favor of major resection versus lesser resection (DSS median not reached versus 52.2 months, P = 0.03; DFS median not reached versus 23.9 months, P < 0.001) were found. In the multivariate analysis, major resection appeared to be a protective factor in DSS [hazard ratio (HR) 0.6, 95% confidence interval (CI) 0.41-0.96, P = 0.031] and DFS (HR 0.5, 95% CI 0.36-0.75, P < 0.001). The surgical approach (VATS versus open surgical resection) had no effect on outcome. Major anatomic resection with lymphadenectomy for pulmonary metastasectomy can be considered in selected CRC patient with sufficient functional reserve to improve the DSS and DFS. Further prospective randomized studies are needed to confirm the present results. © The Author 2016. Published by Oxford University Press

  14. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

    Science.gov (United States)

    Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

    2011-05-06

    The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional

  15. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    Directory of Open Access Journals (Sweden)

    Poeze Martijn

    2011-05-01

    Full Text Available Abstract Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%, non-union (5-21% and early osteo-arthritis (up to 32% which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning. Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation

  16. Impact of an Electronic Cigarette on Smoking Reduction and Cessation in Schizophrenic Smokers: A Prospective 12-Month Pilot Study

    Directory of Open Access Journals (Sweden)

    Pasquale Caponnetto

    2013-01-01

    Full Text Available Background: Cigarette smoking is a tough addiction to break. This dependence is the most common dual diagnosis for individuals with schizophrenia. Currently three effective drugs are approved for smoking cessation: nicotine replacement therapy (NRT, varenicline and bupropion. However, some serious side effects of varenicline have been reported, including depression, suicidal thoughts, and suicide. The use of bupropion also has side effects. It should not be used by people who have epilepsy or any condition that lowers the seizure threshold, nor by people who take a specific class of drugs called monoamine oxidase inhibitors. Hence, there are pharmacodynamic reason to believe they could precipitate or exacerbate psychosis. For its capacity to deliver nicotine and provide a coping mechanism for conditioned smoking cues by replacing some of the rituals associated with smoking gestures, electronic-cigarettes may reduce nicotine withdrawal symptoms without serious side effects. Our recent work with ECs in healthy smokers not intending to quit consistently show surprisingly high success rates. We hypothesised that these positive findings could be replicated in difficult patients with schizophrenia This tool may help smokers with schizophrenia remain abstinent during their quitting attempts or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated for this special population. Methods: In this study we monitored possible modifications in smoking habits of 14 smokers (not intending to quit with schizophrenia experimenting with the “Categoria” e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend six study visits: at baseline, week-4, week-8, week-12 week-24 and week 52. Product use, number of cigarettes smoked, carbon monoxide in exhaled breath (eCO and positive and negative symptoms of schizophrenia levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events were also reviewed. Results: Sustained 50% reduction in the number of cig/day at week-52 was shown in 7/14 (50% participants; their median of 30 cig/day decreasing significantly to 15 cig/day (p = 0.018. Sustained smoking abstinence at week-52 was observed in 2/14 (14.3% participants. Combined sustained 50% reduction and smoking abstinence was shown in 9/14 (64.3% participants. Nausea was observed in 2/14 (14.4% of participants, throat irritation in 2/14 (14.4% of participants, headache in 2/14 (14.4% of participants , and dry cough in 4/14 (28.6% of participants. However, these adverse events diminished substantially by week-24. Overall, one to two cartridges/day were used throughout the study. Positive and negative symptoms of schizophrenia are not increased after smoking reduction/cessation in patients using e-cigarettes. Conclusions: We have shown for the first time that the use of e-cigarette substantially decreased cigarette consumption without causing significant side effects in chronic schizophrenic patients who smoke not intending to quit. This was achieved without negative impacts on the symptoms of schizophrenia as assessed by SAPS and SANS symptoms scales.

  17. Impact of an electronic cigarette on smoking reduction and cessation in schizophrenic smokers: a prospective 12-month pilot study.

    Science.gov (United States)

    Caponnetto, Pasquale; Auditore, Roberta; Russo, Cristina; Cappello, Giorgio Carlo; Polosa, Riccardo

    2013-01-28

    Cigarette smoking is a tough addiction to break. This dependence is the most common dual diagnosis for individuals with schizophrenia. Currently three effective drugs are approved for smoking cessation: nicotine replacement therapy (NRT), varenicline and bupropion. However, some serious side effects of varenicline have been reported, including depression, suicidal thoughts, and suicide. The use of bupropion also has side effects. It should not be used by people who have epilepsy or any condition that lowers the seizure threshold, nor by people who take a specific class of drugs called monoamine oxidase inhibitors. Hence, there are pharmacodynamic reason to believe they could precipitate or exacerbate psychosis. For its capacity to deliver nicotine and provide a coping mechanism for conditioned smoking cues by replacing some of the rituals associated with smoking gestures, electronic-cigarettes may reduce nicotine withdrawal symptoms without serious side effects. Our recent work with ECs in healthy smokers not intending to quit consistently show surprisingly high success rates. We hypothesised that these positive findings could be replicated in difficult patients with schizophrenia This tool may help smokers with schizophrenia remain abstinent during their quitting attempts or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated for this special population. In this study we monitored possible modifications in smoking habits of 14 smokers (not intending to quit) with schizophrenia experimenting with the "Categoria" e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend six study visits: at baseline, week-4, week-8, week-12 week-24 and week 52. Product use, number of cigarettes smoked, carbon monoxide in exhaled breath (eCO) and positive and negative symptoms of schizophrenia levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events were also reviewed. Sustained 50% reduction in the number of cig/day at week-52 was shown in 7/14 (50%) participants; their median of 30 cig/day decreasing significantly to 15 cig/day (p = 0.018). Sustained smoking abstinence at week-52 was observed in 2/14 (14.3%) participants. Combined sustained 50% reduction and smoking abstinence was shown in 9/14 (64.3%) participants. Nausea was observed in 2/14 (14.4%) of participants, throat irritation in 2/14 (14.4%) of participants, headache in 2/14 (14.4%) of participants , and dry cough in 4/14 (28.6%) of participants. However, these adverse events diminished substantially by week-24. Overall, one to two cartridges/day were used throughout the study. Positive and negative symptoms of schizophrenia are not increased after smoking reduction/cessation in patients using e-cigarettes. We have shown for the first time that the use of e-cigarette substantially decreased cigarette consumption without causing significant side effects in chronic schizophrenic patients who smoke not intending to quit. This was achieved without negative impacts on the symptoms of schizophrenia as assessed by SAPS and SANS symptoms scales.

  18. THE REAL PREVALENCE OF EROSIVE ESOPHAGITIS AND BARRETT'S ESOPHAGUS IN SYSTEMIC SCLERODERMA: DATA FROM 12-MONTHS PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Andrey Evgenievich Karateev

    2012-01-01

    Full Text Available Complicated forms of reflux-esophagitis, i.e., erosive esophagitis and Barrett's esophagus (BE — are common types of visceral pathology in systemic scleroderma (SSD, which require adequate therapy and follow up. Although real prevalence of esophageal involvement in SSD in Russian patients remains uncertain. Objective — to identify prevalence of erosive esophagitis and BE, and to quantify gastro-intestinal (GI symptoms in patients with SSD. Material and methods. During 1 year (December 2009 — January 2011 all consecutive SSD patients, hospitalized to FSBI «SRIR» RAMS, after signing informed consent, were subjected to esophagogastroduodenoscopy with biopsy of esophageal mucosa in upper 1/3. Totally 123 patients were examined (96,8% females, 3,2% males, aged 50,5±13,1 years. Esophageal mucous was evaluated for presence of pathologic changes and BE (intestinal metaplasia in biopsy samples was a BE diagnostic criterion. SODA questionnaire was used to quantify GIT symptoms Results. Erosive esophagitis was detected in 30 (24,3% patients, BE — in 11 (8,9%. In 80% of patients marked changes in esophageal mucosa were associated with typical symptoms (heartburn, regurgitaion, dysphagia, while in some cases (in 3 patients erosive esophagitis and BE were asymptomatic. Quantitative evaluation of symptoms with SODA questionnaire demonstrated clear correlation between subjective assessment and severity of esophageal pathologic changes. In patients with erosive gastritis and BE the SODA «pain» and «non-pain» parameters scores were significantly higher and satisfaction in dyspepsia management was lower (p<0,05, then in individuals without erosions and mucosal inflammation. Here was no clear correlation between esophageal pathology and SSD type (limited, diffuse, age, duration of the disease, presence of pulmonary interstitial lesion and Sjogren's syndrome. Patients with erosive esophagitis were significantly more often (36,6% using proton pomp inhibitors as compared to individuals without apparent esophageal pathology (22,0%; p<0,001. Conclusion. Erosive esophagitis is diagnosed in each 4th patient with SSD.EB is also quite common in this pathology, predetermining the necessity of regular endoscopic check-ups in all SSD patients. SODA questionnaire is a useful tool to evaluate the severity of upper GIT symptoms in SSD patients during follow up.

  19. Embolization for the treatment of intractable epistaxis: 12 month outcomes in a two centre case series.

    Science.gov (United States)

    Robinson, Anthony E; McAuliffe, William; Phillips, Timothy J; Phatouros, Constantine C; Singh, Tejinder P

    2017-12-01

    Embolization is a treatment option for intractable epistaxis; however, concerns regarding tissue necrosis, stroke and blindness persist in the literature. A retrospective review of patients from September 2010 to January 2016 treated with embolization for epistaxis was performed. No patient was excluded. Follow-up was 12 months and no patient was lost. 62 embolizations on 59 patients occurred. 21 cases were taking anticoagulants, P2Y12 inhibiting agents or had a systemic coagulopathy. Embolized territories typically involved bilateral distal internal maxillary arteries with unilateral or bilateral facial arteries with polyvinyl alcohol particles. 60 cases had procedural general anaesthesia. There were no major complications. Six died of unrelated causes. Of the surviving 53 patients, excluding the 3 patients with hereditary haemorrhagic telangiectasia, 5 had recurrent epistaxis post-embolization. Four were taking P2Y12 inhibiting and/or anticoagulants, none of which required surgery, prolonged packing or repeat embolization. This group had a propensity to recur compared with cases taking aspirin only or no antiplatelet/anticoagulant (77.8 vs 97.1%, p = 0.04). The fifth underwent repeat embolization after previously only having ipsilateral distal internal maxillary and facial arteries treated. Embolization for epistaxis is safe and effective. Of those who had recurrent epistaxis post embolization, most were taking P2Y12 inhibition and/or anticoagulation. We prefer bilateral distal internal maxillary artery and unilateral facial artery embolization under general anaesthesia for optimal safety and efficacy. Advances in knowledge: Embolization with this technique seems to facilitate superior outcomes without complications despite the large proportion of patients taking anticoagulating or P2Y12 inhibiting agents.

  20. Co-occurrence of posttraumatic stress symptoms, pain, and disability 12 months after traumatic injury

    Science.gov (United States)

    Giummarra, Melita J.; Casey, Sara L.; Devlin, Anna; Ioannou, Liane J.; Gibson, Stephen J.; Georgiou-Karistianis, Nellie; Jennings, Paul A.; Cameron, Peter A.; Ponsford, Jennie

    2017-01-01

    Abstract Introduction: Chronic pain is common after traumatic injury and frequently co-occurs with posttraumatic stress disorder (PTSD) and PTSD symptoms (PTSS). Objectives: This study sought to understand the association between probable PTSD, PTSS, and pain. Methods: Four hundred thirty-three participants were recruited from the Victorian Orthopaedic Trauma Outcomes Registry and Victorian State Trauma Registry and completed outcome measures. Participants were predominantly male (n = 324, 74.8%) and aged 17-75 years at the time of their injury (M = 44.83 years, SD = 14.16). Participants completed the Posttraumatic Stress Disorder Checklist, Brief Pain Inventory, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia, EQ-5D-3L and Roland-Morris Disability Questionnaire 12 months after hospitalization for traumatic injury. Data were linked with injury and hospital admission data from the trauma registries. Results: Those who reported having current problems with pain were 3 times more likely to have probable PTSD than those without pain. Canonical correlation showed that pain outcomes (pain severity, interference, catastrophizing, kinesiophobia, self-efficacy, and disability) were associated with all PTSSs, but especially symptoms of cognition and affect, hyperarousal, and avoidance. Posttraumatic stress disorder symptoms, on the contrary, were predominantly associated with high catastrophizing and low self-efficacy. When controlling for demographics, pain and injury severity, depression, and self-efficacy explained the greatest proportion of the total relationship between PTSS and pain-related disability. Conclusion: Persons with both PTSS and chronic pain after injury may need tailored interventions to overcome fear-related beliefs and to increase their perception that they can engage in everyday activities, despite their pain. PMID:29392235

  1. Immediate Implant Placement and Provisionalization Using the Patient's Extracted Crown: 12-Month Follow-Up.

    Science.gov (United States)

    Deliberador, Tatiana Miranda; Begnini, Gilmar José; Tomazinho, Flávia; Rezende, Carlos Eduardo Edwards; Florez, Fernando Luis Esteban; Leonardi, Denise Piotto

    2018-03-01

    Immediate placement and provisionalization of implants in fresh sockets has been previously demonstrated to be a predictable treatment in the restoration of non-recoverable teeth in the anterior regions of the maxilla. This article reports a clinical case in which an immediate implant placement protocol was used in combination with two distinct and sequential grafts (bovine bone and connective tissue, respectively) followed by immediate implant provisionalization using the patient's crown of an extracted tooth. Physical, clinical, and image examinations of the patient (female, 23 years old) revealed a maxillary central incisor (tooth No. 8) with slight mobility due the presence of extensive cervical resorption. The treatment proposed was the atraumatic extraction of the tooth followed by immediate implant placement and provisionalization. Two grafts (bovine bone and connective tissue) were used due to the presence of a very thin maxillary bone plate associated with a thin gingival biotype. The use of the extracted crown as a temporary crown after immediate implant placement resulted in immediate attainment of an esthetically pleasing outcome and long-term favorable results. The treatment protocol proposed can be efficiently used to immediately restore the patient's esthetics and function while maintaining the health, volume, and contours of gingival tissues over a 12-month follow-up period. Anterior teeth extractions typically require the execution of single-unit prostheses using dental materials of synthetic origin (such as polymers), which often are incapable of achieving the esthetic and physiological results patients expect. The use of the patient's own crown was demonstrated, which allowed good clinical results to be achieved and the natural shape and function of tissues to be maintained.

  2. Immediate and early function of Brånemark System implants placed in the esthetic zone: a 1-year prospective clinical multicenter study.

    Science.gov (United States)

    Maló, Paulo; Friberg, Bertil; Polizzi, Giovanni; Gualini, Federico; Vighagen, Torbjörn; Rangert, Bo

    2003-01-01

    Immediate/early implant function means great benefits for patients and therapists because treatment time and cost can be substantially reduced. This concept has become an accepted alternative for complete arch fixed restorations in the mandible, and clinical documentation is emerging for other indications. The purpose of this prospective clinical multicenter study was to evaluate the outcome of implants placed in incisor, canine, and premolar regions in maxillas or mandibles. Implants were loaded with provisional crowns and bridges on the same day or within a few days and were followed up for 1 year during function. Four centers treated 76 patients each in need of an implant-retained prosthesis in the anterior and premolar regions in the maxilla or mandible. A total of 116 titanium implants with machined surfaces (Brånemark System , Nobel Biocare AB, Gothenburg, Sweden) were placed: 74 in maxillas and 42 in mandibles. Eighty-seven prostheses were made, of which 63 were single crowns and 24 were bridges (supported by 53 splinted implants). Twenty-two implants in 14 patients were placed in fresh extraction sites. The goal with the preparation and insertion technique was to achieve good primary implant stability and a minimum implant insertion torque of 30 Ncm before the implant was completely seated. The occlusion was adjusted to eliminate direct contact with the provisional prostheses. After 6 months, the patients received their permanent prostheses. Sixty-seven patients were followed for 1 year. Five implants were lost in five patients, three in the maxilla and two in the mandible. Four of the lost implants were single-tooth replacements and one was splinted. The cumulative survival rate (CSR) was 95.7% for all implants after 1 year and 93.7% and 98.1% for single-tooth and splinted implants, respectively. There were no implant losses in the extraction sites. The CSR of 96% at 1 year indicates that immediate function of Brånemark System implants placed in incisor

  3. Simple Rules, Not So Simple: The Use of International Ovarian Tumor Analysis (IOTA) Terminology and Simple Rules in Inexperienced Hands in a Prospective Multicenter Cohort Study.

    Science.gov (United States)

    Meys, Evelyne; Rutten, Iris; Kruitwagen, Roy; Slangen, Brigitte; Lambrechts, Sandrina; Mertens, Helen; Nolting, Ernst; Boskamp, Dieuwke; Van Gorp, Toon

    2017-12-01

     To analyze how well untrained examiners - without experience in the use of International Ovarian Tumor Analysis (IOTA) terminology or simple ultrasound-based rules (simple rules) - are able to apply IOTA terminology and simple rules and to assess the level of agreement between non-experts and an expert.  This prospective multicenter cohort study enrolled women with ovarian masses. Ultrasound was performed by non-expert examiners and an expert. Ultrasound features were recorded using IOTA nomenclature, and used for classifying the mass by simple rules. Interobserver agreement was evaluated with Fleiss' kappa and percentage agreement between observers.  50 consecutive women were included. We observed 46 discrepancies in the description of ovarian masses when non-experts utilized IOTA terminology. Tumor type was misclassified often (n = 22), resulting in poor interobserver agreement between the non-experts and the expert (kappa = 0.39, 95 %-CI 0.244 - 0.529, percentage of agreement = 52.0 %). Misinterpretation of simple rules by non-experts was observed 57 times, resulting in an erroneous diagnosis in 15 patients (30 %). The agreement for classifying the mass as benign, malignant or inconclusive by simple rules was only moderate between the non-experts and the expert (kappa = 0.50, 95 %-CI 0.300 - 0.704, percentage of agreement = 70.0 %). The level of agreement for all 10 simple rules features varied greatly (kappa index range: -0.08 - 0.74, percentage of agreement 66 - 94 %).  Although simple rules are useful to distinguish benign from malignant adnexal masses, they are not that simple for untrained examiners. Training with both IOTA terminology and simple rules is necessary before simple rules can be introduced into guidelines and daily clinical practice. © Georg Thieme Verlag KG Stuttgart · New York.

  4. Level of Discomfort Decreases After the Administration of Continuous Palliative Sedation: A Prospective Multicenter Study in Hospices and Palliative Care Units.

    Science.gov (United States)

    van Deijck, Rogier H P D; Hasselaar, Jeroen G J; Verhagen, Stans C A H H V M; Vissers, Kris C P; Koopmans, Raymond T C M

    2016-09-01

    A gold standard or validated tool for monitoring the level of discomfort during continuous palliative sedation (CPS) is lacking. Therefore, little is known about the course of discomfort in sedated patients, the efficacy of CPS, and the determinants of discomfort during CPS. To identify the course of discomfort in patients receiving CPS. A prospective observational multicenter study in nine hospices and palliative care units was performed. The Discomfort Scale-Dementia of Alzheimer Type (DS-DAT) was independently assessed for monitoring of patient discomfort during CPS. The DS-DAT scores range from 0 (no observed discomfort) to a maximum of 27 (high level of observed discomfort). Using a mixed model, the mean group score of discomfort between four predefined time frames of CPS was compared, correcting for confounding patient characteristics. A total of 130 patients were sedated, and the DS-DAT was completed in 106 patients at least once. The median duration of the sedation in these 106 patients was 25.5 hours (range 2-161). The mean score of the DS-DAT in the phase before sedation was 12.16 (95% CI 9.83-14.50) and decreased significantly to 8.06 (95% CI 5.53-10.58) in the titration phase of sedation. The mean score of the DS-DAT in the final phase of sedation was 7.42 (95% CI 4.90-9.94). This study shows that CPS is associated with a decrease in the level of discomfort within an acceptable time frame, although in some sedated patients higher levels of discomfort in the last hours of life occurred. Although the DS-DAT seems to be of value for monitoring the level of discomfort during CPS, the results of this study should be interpreted within the constraints of the limitations, and further research on the psychometric properties of this tool is needed before the DS-DAT can be used in clinical practice. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  5. Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study.

    Science.gov (United States)

    Brunori, Giuliano; Viola, Battista F; Parrinello, Giovanni; De Biase, Vincenzo; Como, Giovanna; Franco, Vincenzo; Garibotto, Giacomo; Zubani, Roberto; Cancarini, Giovanni C

    2007-05-01

    A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. Mortality, hospitalization, and metabolic markers. 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

  6. Diagnostic Accuracy of the Aortic Dissection Detection Risk Score Plus D-Dimer for Acute Aortic Syndromes: The ADvISED Prospective Multicenter Study.

    Science.gov (United States)

    Nazerian, Peiman; Mueller, Christian; Soeiro, Alexandre de Matos; Leidel, Bernd A; Salvadeo, Sibilla Anna Teresa; Giachino, Francesca; Vanni, Simone; Grimm, Karin; Oliveira, Múcio Tavares; Pivetta, Emanuele; Lupia, Enrico; Grifoni, Stefano; Morello, Fulvio

    2018-01-16

    Acute aortic syndromes (AASs) are rare and severe cardiovascular emergencies with unspecific symptoms. For AASs, both misdiagnosis and overtesting are key concerns, and standardized diagnostic strategies may help physicians to balance these risks. D-dimer (DD) is highly sensitive for AAS but is inadequate as a stand-alone test. Integration of pretest probability assessment with DD testing is feasible, but the safety and efficiency of such a diagnostic strategy are currently unknown. In a multicenter prospective observational study involving 6 hospitals in 4 countries from 2014 to 2016, consecutive outpatients were eligible if they had ≥1 of the following: chest/abdominal/back pain, syncope, perfusion deficit, and if AAS was in the differential diagnosis. The tool for pretest probability assessment was the aortic dissection detection risk score (ADD-RS, 0-3) per current guidelines. DD was considered negative (DD-) if 1. Two hundred forty-one patients (13%) had AAS: 125 had type A aortic dissection, 53 had type B aortic dissection, 35 had intramural aortic hematoma, 18 had aortic rupture, and 10 had penetrating aortic ulcer. A positive DD test result had an overall sensitivity of 96.7% (95% confidence interval [CI], 93.6-98.6) and a specificity of 64% (95% CI, 61.6-66.4) for the diagnosis of AAS; 8 patients with AAS had DD-. In 294 patients with ADD-RS=0/DD-, 1 case of AAS was observed. This yielded a failure rate of 0.3% (95% CI, 0.1-1.9) and an efficiency of 15.9% (95% CI, 14.3-17.6) for the ADD-RS=0/DD- strategy. In 924 patients with ADD-RS ≤1/DD-, 3 cases of AAS were observed. This yielded a failure rate of 0.3% (95% CI, 0.1-1) and an efficiency of 49.9% (95% CI, 47.7-52.2) for the ADD-RS ≤1/DD- strategy. Integration of ADD-RS (either ADD-RS=0 or ADD-RS ≤1) with DD may be considered to standardize diagnostic rule out of AAS. URL: https://www.clinicaltrials.gov. Unique identifier: NCT02086136. © 2017 American Heart Association, Inc.

  7. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study.

    Science.gov (United States)

    Karpecki, Paul; Depaolis, Michael; Hunter, Judy A; White, Eric M; Rigel, Lee; Brunner, Lynne S; Usner, Dale W; Paterno, Michael R; Comstock, Timothy L

    2009-03-01

    Besifloxacin ophthalmic suspension 0.6% is a new topical fluoroquinolone for the treatment of bacterial conjunctivitis. Besifloxacin has potent in vitro activity against a broad spectrum of ocular pathogens, including drug-resistant strains. The primary objective of this study was to compare the clinical and microbiologic efficacy of besifloxacin ophthalmic suspension 0.6% with that of vehicle (the formulation without besifloxacin) in the treatment of bacterial conjunctivitis. This was a multicenter, prospective, randomized, double-masked, vehicle-controlled, parallel-group study in patients with acute bacterial conjunctivitis. Patients received either topical besifloxacin ophthalmic suspension or vehicle administered 3 times daily for 5 days. At study entry and on days 4 and 8 (visits 2 and 3), a clinical assessment of ocular signs and symptoms was performed in both eyes, as well as pinhole visual acuity testing, biomicroscopy, and culture of the infected eye(s). An ophthalmoscopic examination was performed at study entry and on day 8. The primary efficacy outcome measures were clinical resolution and eradication of the baseline bacterial infection on day 8 in culture-confirmed patients. The safety evaluation included adverse events, changes in visual acuity, and biomicroscopy and ophthalmoscopy findings in all patients who received at least 1 dose of active treatment or vehicle. The safety population consisted of 269 patients (mean [SD] age, 34.2 [22.3] years; 60.2% female; 82.5% white) with acute bacterial conjunctivitis. The culture-confirmed intent-to-treat population consisted of 118 patients (60 besifloxacin ophthalmic suspension, 58 vehicle). Significantly more patients receiving besifloxacin ophthalmic suspension than vehicle had clinical resolution of the baseline infection at visit 3 (44/60 [73.3%] vs 25/58 [43.1%], respectively; P suspension compared with vehicle at visit 3 (53/60 [88.3%] vs35/58 [60.3%]; P suspension 0.6% given 3 times daily for 5 days

  8. External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life

    Energy Technology Data Exchange (ETDEWEB)

    Gay, Hiram A., E-mail: hiramgay@wustl.edu [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri (United States); Sanda, Martin G. [Department of Urology, Emory University School of Medicine, Atlanta, Georgia (United States); Liu, Jingxia; Wu, Ningying [Division of Public Health Sciences, Washington University School of Medicine, St. Louis, Missouri (United States); Hamstra, Daniel A. [Texas Center for Proton Therapy, Irving, Texas (United States); Wei, John T.; Dunn, Rodney L. [Department of Urology, University of Michigan, Ann Arbor, Michigan (United States); Klein, Eric A. [Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, Ohio (United States); Sandler, Howard M. [Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California (United States); Saigal, Christopher S. [Department of Urology, University of California at Los Angeles, Los Angeles, California (United States); Litwin, Mark S. [Department of Urology, University of California at Los Angeles, Los Angeles, California (United States); Health Policy and Management, University of California at Los Angeles, Los Angeles, California (United States); Kuban, Deborah A. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Hembroff, Larry [Institute for Public Policy and Social Research, Michigan State University, East Lansing, Michigan (United States); Regan, Meredith M. [Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts (United States); Chang, Peter [Department of Surgery, Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (United States); Michalski, Jeff M. [Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri (United States); Regan, Meredith; Hembroff, Larry; Wei, John T.; Hamstra, Dan; and others

    2017-06-01

    Purpose: The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. Methods and Materials: We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the χ{sup 2} or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level. Results: For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively. Conclusions: Compared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression

  9. Preoperative prediction of lymph node metastasis and deep stromal invasion in women with invasive cervical cancer: prospective multicenter study using 2D and 3D ultrasound.

    Science.gov (United States)

    Pálsdóttir, K; Fischerova, D; Franchi, D; Testa, A; Di Legge, A; Epstein, E

    2015-04-01

    To determine how various objective two-dimensional (2D) and three-dimensional (3D) ultrasound parameters allow prediction of deep stromal tumor invasion and lymph node involvement, in comparison to subjective ultrasound assessment, in women scheduled for surgery for cervical cancer. This was a prospective multicenter trial including 104 women with cervical cancer at FIGO Stages IA2-IIB, verified histologically. Patients scheduled for surgery underwent a preoperative ultrasound examination. The value of various 2D (size, color score) and 3D (volume, vascular indices) ultrasound parameters was compared to that of subjective assessment in the prediction of deep stromal tumor invasion and lymph node involvement. Histology obtained from radical hysterectomy or trachelectomy and pelvic lymphadenectomy was considered as the gold standard for assessment. All women underwent pelvic lymphadenectomy, with 99 (95%) undergoing subsequent radical surgery; five underwent only pelvic lymphadenectomy because of the presence of a positive sentinel lymph node. Women with deep stromal invasion or lymph node involvement had significantly larger tumors (diameter and volume) but there was no correlation with vascular indices measured on 3D ultrasound. Subjective evaluation was superior (AUC, 0.93; sensitivity, 90.5%; specificity, 97.2%) in the prediction of deep stromal invasion when compared to any objective measurement technique, with maximal tumor diameter at 20.5-mm cut-off (AUC, 0.83; sensitivity, 90.5%; specificity, 61.1%) and 3D tumor volume at 9.1-mm(3) cut-off (AUC, 0.85; sensitivity, 79.4%; specificity, 83.3%) providing the best performance among the objective parameters. Both subjective assessment and objective measurements were poorly predictive of lymph node involvement. In women with cervical cancer, subjective ultrasound evaluation allowed better prediction of deep stromal invasion than did objective measurements; however, neither subjective evaluation nor objective

  10. MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study.

    Science.gov (United States)

    Chopko, Bohdan; Caraway, David L

    2010-01-01

    Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion. When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study were treated with mild, an ultra-minimally invasive lumbar decompression procedure using a dorsal approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding muscular and skeletal structure. To assess the clinical application and patient safety and functional outcomes of the mild lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis. Multi-center, non-blinded, prospective clinical study. Fourteen US spine specialist practices. Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was available for 75 patients. Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2 Health Survey. Outcomes were assessed at baseline and 6 weeks post-treatment. There were no major device or procedure-related complications reported in this patient cohort. At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI, ZCQ, and SF-12v2 was statistically and clinically significant in this study. This is a preliminary report encompassing 6-week follow-up. There was no control group

  11. Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study.

    Science.gov (United States)

    Fruehauf, Stefan; Otremba, Burkhard; Stötzer, Oliver; Rudolph, Christine

    2016-11-01

    Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study (ClinicalTrials.gov identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy. This was a prospective, multicenter, non-interventional, longitudinal study. Consenting adult patients with solid tumors or hematologic malignancies for whom cytotoxic chemotherapy and treatment with biosimilar filgrastim was planned were enrolled. Among the enrolled patients (N = 386), 81% were female, with a median age (range) of 61 (22-92) years, with 39% >65 years old. Most patients (n = 338; 88%) had solid tumors and the remainder (n = 49; 13%) had hematological malignancies. The majority of the patients (64%) received biosimilar filgrastim as primary prophylaxis and 36% as secondary prophylaxis. At the follow-up visits, for the majority of patients (95.6%) there had been no change in chemotherapy dose due to FN. For two patients (0.5%) the chemotherapy was discontinued due to FN and for four patients (1.0%) the chemotherapy dose was reduced due to FN. For the majority of patients (96.9%) the chemotherapy cycle following the first biosimilar filgrastim treatment was not delayed due to FN. For 3 patients (0.8%), the chemotherapy was delayed following the first biosimilar filgrastim treatment. Less than one-third (29.8%) of the patients experienced ≥1 adverse event that was at least potentially related to biosimilar filgrastim treatment. Biosimilar filgrastim was effective and well-tolerated in both the primary and secondary prophylactic setting in patients undergoing chemotherapy for solid tumors and hematological malignancies. Clinical

  12. Surgical data and early postoperative outcomes after minimally invasive lumbar interbody fusion: results of a prospective, multicenter, observational data-monitored study.

    Directory of Open Access Journals (Sweden)

    Paulo Pereira

    Full Text Available Minimally invasive lumbar interbody fusion (MILIF offers potential for reduced operative morbidity and earlier recovery compared with open procedures for patients with degenerative lumbar disorders (DLD. Firm conclusions about advantages of MILIF over open procedures cannot be made because of limited number of large studies of MILIF in a real-world setting. Clinical effectiveness of MILIF in a large, unselected real-world patient population was assessed in this Prospective, monitored, international, multicenter, observational study.To observe and document short-term recovery after minimally invasive interbody fusion for DLD.In a predefined 4-week analysis from this study, experienced surgeons (≥ 30 MILIF surgeries pre-study treated patients with DLD by one- or two-level MILIF. The primary study objective was to document patients' short-term post-interventional recovery (primary objective including back/leg pain (visual analog scale [VAS], disability (Oswestry Disability Index [ODI], health status (EQ-5D and Patient satisfaction.At 4 weeks, 249 of 252 patients were remaining in the study; the majority received one-level MILIF (83% and TLIF was the preferred approach (94.8%. For one-level (and two-level procedures, surgery duration was 128 (182 min, fluoroscopy time 115 (154 sec, and blood-loss 164 (233 mL. Time to first ambulation was 1.3 days and time to study-defined surgery recovery was 3.2 days. Patients reported significantly (P < 0.0001 reduced back pain (VAS: 2.9 vs 6.2, leg pain (VAS: 2.5 vs 5.9, and disability (ODI: 34.5% vs 45.5%, and a significantly (P < 0.0001 improved health status (EQ-5D index: 0.61 vs 0.34; EQ VAS: 65.4 vs 52.9 4 weeks postoperatively. One adverse event was classified as related to the minimally invasive surgical approach. No deep site infections or deaths were reported.For experienced surgeons, MILIF for DLD demonstrated early benefits (short time to first ambulation, early recovery, high patient satisfaction

  13. Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial.

    Science.gov (United States)

    Zhou, Luqian; Li, Xiaoying; Guan, Lili; Chen, Jianhua; Guo, Bingpeng; Wu, Weiliang; Huo, Yating; Zhou, Ziqing; Liang, Zhenyu; Zhou, Yuqi; Tan, Jie; Chen, Xin; Song, Yuanlin; Chen, Rongchang

    2017-01-01

    The benefits of noninvasive positive pressure ventilation (NPPV) in patients with hypercapnic COPD are controversial. It is presumed that methodology and appropriate use of NIV ventilator might be crucial for the outcomes. With the new built-in software, the performance of NIV can be monitored at home, which can guarantee the compliance and appropriate use. This study investigated effects of home use of NIV in hypercapnia in COPD patients using the NIV ventilator with built-in software for monitoring. The current multicenter prospective, randomized, controlled trial enrolled patients with stable GOLD stages III and IV hypercapnic COPD. Patients were randomly assigned via a computer-generated randomization sequence, with a block size of four patients, to continue optimized treatment (control group) or to receive additional NPPV (intervention group) for 3 months. The primary outcome was arterial carbon dioxide pressure (PaCO 2 ). Data were derived from built-in software and analyzed every 4 weeks. Analysis was carried out with the intention to treat. This study is registered with ClinicalTrials.gov, number NCT02499718. Patients were recruited from 20 respiratory units in China from October 1, 2015, and recruitment was terminated with a record of the vital statistics on May 31, 2016. A total of 115 patients were randomly assigned to the NPPV group (n=57) or the control group (n=58). Patients complied well with NPPV therapy (mean [± standard deviation] day use 5.6±1.4 h). The mean estimation of leaks was 37.99±13.71 L/min. The changes in PaCO 2 (-10.41±0.97 vs -4.32±0.68 mmHg, P =0.03) and 6-min walk distance (6MWD) (38.2% vs 18.2%, P =0.02) were statistically significant in the NPPV group versus the control group. COPD assessment test (CAT) showed a positive trend ( P =0.06) in favor of the NPPV group. Pulmonary function and dyspnea were not different between groups. Ventilators equipped with built-in software provided methodology for monitoring NIV use at home

  14. External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life

    International Nuclear Information System (INIS)

    Gay, Hiram A.; Sanda, Martin G.; Liu, Jingxia; Wu, Ningying; Hamstra, Daniel A.; Wei, John T.; Dunn, Rodney L.; Klein, Eric A.; Sandler, Howard M.; Saigal, Christopher S.; Litwin, Mark S.; Kuban, Deborah A.; Hembroff, Larry; Regan, Meredith M.; Chang, Peter; Michalski, Jeff M.; Regan, Meredith; Hembroff, Larry; Wei, John T.; Hamstra, Dan

    2017-01-01

    Purpose: The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. Methods and Materials: We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the χ"2 or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level. Results: For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively. Conclusions: Compared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression, lack of

  15. SLCO1B1 and SLC19A1 gene variants and irinotecan-induced rapid response and survival: a prospective multicenter pharmacogenetics study of metastatic colorectal cancer.

    Directory of Open Access Journals (Sweden)

    Liu Huang

    Full Text Available Rapid response to chemotherapy in metastatic colorectal cancer (mCRC patients (response within 12 weeks of chemotherapy may increase the chance of complete resection and improved survival. Few molecular markers predict irinotecan-induced rapid response and survival. Single-nucleotide polymorphisms (SNPs in solute carrier genes are reported to correlate with the variable pharmacokinetics of irinotecan and folate in canc