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.

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

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

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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

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.

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.

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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.

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

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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…

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.

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

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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.

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

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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.

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.

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

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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.

Surgical site infections in Italian Hospitals: a prospective multicenter study

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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

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

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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.

Suicide Attempts within 12 Months of Treatment for Substance Use Disorders

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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…

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.

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

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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.

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.

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

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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.

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

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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

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

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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.

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…

Radioembolisation for liver metastases: results from a prospective 151 patient multi-institutional phase II study.

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Benson, Al B; Geschwind, Jean-Francois; Mulcahy, Mary F; Rilling, William; Siskin, Gary; Wiseman, Greg; Cunningham, James; Houghton, Bonny; Ross, Mason; Memon, Khairuddin; Andrews, James; Fleming, Chad J; Herman, Joseph; Nimeiri, Halla; Lewandowski, Robert J; Salem, Riad

2013-10-01

To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with (90)Y (glass) radioembolisation in a prospective, multicenter phase II study. 151 patients with liver metastases (colorectal n=61, neuroendocrine n=43 and other tumour types n=47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival. Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8%), elevated alkaline phospatase (8.1%), hyperbilirubinemia (5.3%), lymphopaenia (4.1%), ascites (3.4%) and vomiting (3.4%). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59%, 93% and 63% for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from (90)Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached. Patients with liver metastases can be safely treated with (90)Y microspheres. This study is the first to demonstrate technical and dose reproducibility of (90)Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

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

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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

Aripiprazole for Irritability in Asian Children and Adolescents with Autistic Disorder: A 12-Week, Multinational, Multicenter, Prospective Open-Label Study.

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Kim, Hyo-Won; Park, Eun-Jin; Kim, Ji-Hoon; Boon-Yasidhi, Vitharon; Tarugsa, Jariya; Reyes, Alexis; Manalo, Stella; Joung, Yoo-Sook

2018-04-24

We investigated the effectiveness and tolerability of aripiprazole in the treatment of irritability in Asian children and adolescents (6-17 years) with autistic disorder in a 12-week, multinational, multicenter, open-label study. Sixty-seven subjects (10.0 ± 3.1 years old, 52 boys) were enrolled and treated with flexibly dosed aripiprazole for 12 weeks (mean dose, 5.1 ± 2.5 mg; range 2-15 mg). Aripiprazole significantly reduced the mean caregiver-rated scores for the Irritability, Lethargy/Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate Speech subscales of the Aberrant Behavior Checklist from baseline to week 12 (p autistic disorder. Further studies with larger sample sizes and longer treatment durations are required.

Pretransplant IgA-Anti-Beta 2 Glycoprotein I Antibodies As a Predictor of Early Graft Thrombosis after Renal Transplantation in the Clinical Practice: A Multicenter and Prospective Study

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Jose M. Morales

2018-03-01

Full Text Available BackgroundGraft thrombosis is a devastating complication after renal transplantation. We recently described the association of anti-beta-2-glycoprotein-I (IgA-ab2GP1 antibodies with early graft loss mainly caused by thrombosis in a monocenter study.MethodsMulticenter prospective observational cohort study.Setting and participantsSeven hundred forty patients from five hospitals of the Spanish Forum Renal Group transplanted from 2000 to 2002 were prospectively followed-up for 10 years.OutcomesEarly graft loss and graft loss by thrombosis.MeasurementsThe presence of IgA anti-B2GP1 antibodies in pretransplant serum was examined using the same methodology in all the patients.ResultsAt transplantation, 288 patients were positive for IgA-B2GP1 (39%, Group-1 and the remaining were negative (Group-2. Graft loss at 6 months was higher in Group-1 (12.5 vs. 4.2% p < 0.001, vessel thrombosis being the most frequent cause of early graft loss, especially in Group-1 (6.9 vs. 0.4% p < 0.001. IgA-aB2GP1 was the most important independent risk factor for graft thrombosis (hazard ratio: 13.83; 95% CI: 3.17–60.27, p < 0.001. Furthermore, the, presence of IgA-aB2GP1 was associated with early graft loss and delayed graft function. At 10 years, survival figures were also lower in Group-1: graft survival was lower compared with Group-2 (60.4 vs. 76.8%, p < 0.001. Mortality was significantly higher in Group-1 (19.8 vs. 12.2%, p = 0.005.LimitationsPatients were obtained during a 3-year period (1 January 2000–31 December 2002 and kidneys were only transplanted from brain-dead donors. Nowadays, the patients are older and the percentage of sensitized and retransplants is high.ConclusionIn a prospective observational multicenter study, we were able to corroborate that pretransplant presence of IgA-aB2GP1 was the main risk factor for graft thrombosis and early graft loss. Therefore, a prospective study is needed to evaluate the efficacy and safety

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

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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.

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.

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...

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.

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.

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

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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.

[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.

Transobturator TVT-O versus retropubic TVT: results of a multicenter randomized controlled trial at 24 months follow-up.

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Deffieux, Xavier; Daher, Nagib; Mansoor, Aslam; Debodinance, Philippe; Muhlstein, Joël; Fernandez, Hervé

2010-11-01

The purpose of this study is to compare the retropubic tension-free vaginal tape (TVT) procedure with the inside-out transobturator approach (TVT-O). Multicenter randomized controlled trial. One hundred forty-nine patients were randomly allocated to either TVT (n = 75) or TVT-O (n = 74). Interview, medical examination, pain scores, success rates, and quality of life assessment were recorded pre-operatively, and 2, 6, 12, and 24 months post-operatively. One hundred forty-nine patients underwent surgery, and 132 completed a 24-month follow-up. Bladder injury rate was 5% (4/75) in the TVT group and 2% (2/74) in the TVT-O group (p = 0.68). There was no significant difference between the two groups, concerning overall cure rate and the patients' satisfaction rate at 24 months follow-up. The range of mean pain scores was significantly higher after the TVT-O procedure post-operatively but not at 24 months follow-up. TVT and TVT-O procedures both have an outcome associated with an increase in quality of life with no significant differences in satisfaction rates at 2 years follow-up.

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.

A Multicenter, Prospective Study of a New Fully Covered Expandable Metal Biliary Stent for the Palliative Treatment of Malignant Bile Duct Obstruction

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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.

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

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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

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

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

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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.

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,

Prenatal phthalate exposures and child temperament at 12 and 24 months.

Science.gov (United States)

Singer, Alison B; Wolff, Mary S; Silva, Manori J; Calafat, Antonia M; Engel, Stephanie M

2017-09-01

Gestational phthalate exposures have been adversely associated with attention, externalizing, and internalizing behaviors in childhood. Early childhood temperament may be a marker of later behavioral patterns. We therefore sought to determine whether gestational phthalate exposures were associated with infant and toddler temperament. The Mount Sinai Children's Environmental Health Study is a prospective cohort study of children born between May 1998 and July 2001 in New York City (N=404). Phthalate metabolites were measured in spot urine samples collected from pregnant women in their third trimester. Child temperament was assessed by parental report at 12-months using the Infant Behavior Questionnaire (IBQ) (N=204) and at 24-months using the Toddler Behavior Assessment Questionnaire (TBAQ) (N=279). We used multiple linear regression to evaluate associations between urinary phthalate metabolites and eleven temperament domains. Phthalate biomarker concentrations were weakly associated with lower gross motor activity levels as well as higher duration of orienting at the 12-month assessment. Mono(3-carboxypropyl) phthalate (MCPP), monobenzyl phthalate (MBzP) and the sum of metabolites of di(2-ethylhexyl) phthalate (∑DEHP) were associated with lower levels of smiling and laughing at 12 months. At 24-months, social fear and lower pleasure was linked to higher concentrations of MCPP and MBzP, and higher ∑DEHP was weakly associated with increased anger levels at 24-months. Though we observed some weak associations between biomarkers of prenatal exposure to phthalates and temperament at 12- and 24-months, overall phthalates biomarkers were not strongly associated with alterations in temperament. Copyright © 2017. Published by Elsevier B.V.

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.

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.

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.

Change in clinical indices following laser or scalpel treatment for periodontitis: A split-mouth, randomized, multi-center trial

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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.

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.

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.

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.

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

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

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.

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.

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...

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.

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.

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.

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.

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.

Stapled trans-anal rectal resection (STARR) by a new dedicated device for the surgical treatment of obstructed defaecation syndrome caused by rectal intussusception and rectocele: early results of a multicenter prospective study.

Science.gov (United States)

Renzi, Adolfo; Talento, Pasquale; Giardiello, Cristiano; Angelone, Giovanni; Izzo, Domenico; Di Sarno, Giandomenico

2008-10-01

Obstructed defaecation syndrome (ODS) represents a very common clinical problem. The aim of the this prospective multicenter study was to evaluate the efficacy and safety of stapler trans-anal rectal resection (STARR) performed by a new dedicated device, CCS-30 Contour Transtar, in patients with ODS caused by rectal intussusception (RI) and/or rectocele (RE). All the patients who underwent STARR for ODS caused by RI and/or RE at Colorectal Surgery Units of S. Stefano Hospital, Naples, Gepos Hospital, Telese, Benevento and S. Maria della Pietà Hospital, Casoria, Naples, Italy were prospectively introduced into a database. Preoperatively, all the patients underwent anorectal manometry and cinedefecography. The grade of ODS was assessed using a dedicated obstructed defaecation syndrome score (ODS-S). All the patients with a ODS-S >or=12 and RI and/or RE were enrolled. Patients were followed up clinically at 6 months. Thirty patients, 28 (93.3%) women, mean age 56.6+/-12.7 years, underwent STARR, by Transtar, between February and October 2006. Preoperatively, ODS-S was 15.8+/-2.4. RI was present in 26 (89.6%) and RE (34.4+/-15.2 mm) in 27 (93.1%) patients. No major postoperative complications occurred. The length of hospital stay was 2.5+/-0.6 days. At 6-month follow-up, ODS-S was 5.0+/-2.3 (P<0.001). Successful outcome was achieved in 25 (86.2%) patients. STARR, performed by the new dedicated device, CCS-30 Contour Transtar, seems to be an effective and safe procedure to treat ODS caused by RE and/or RI. A longer follow-up and a larger number of patients is needed to confirm these results.

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)...

Inadequacy of 3-month Oswestry Disability Index outcome for assessing individual longer-term patient experience after lumbar spine surgery.

Science.gov (United States)

Asher, Anthony L; Chotai, Silky; Devin, Clinton J; Speroff, Theodore; Harrell, Frank E; Nian, Hui; Dittus, Robert S; Mummaneni, Praveen V; Knightly, John J; Glassman, Steven D; Bydon, Mohamad; Archer, Kristin R; Foley, Kevin T; McGirt, Matthew J

2016-08-01

OBJECTIVE Prospective longitudinal outcomes registries are at the center of evidence-driven health care reform. Obtaining real-world outcomes data at 12 months can be costly and challenging. In the present study, the authors analyzed whether 3-month outcome measurements sufficiently represent 12-month outcomes for patients with degenerative lumbar disease undergoing surgery. METHODS Data from 3073 patients undergoing elective spine surgery for degenerative lumbar disease were entered into a prospective multicenter registry (N(2)QOD). Baseline, 3-month, and 12-month follow-up Oswestry Disability Index (ODI) scores were recorded. The absolute differences between actual 12- and 3-month ODI scores was evaluated. Additionally, the authors analyzed the absolute difference between actual 12-month ODI scores and a model-predicted 12-month ODI score (the model used patients' baseline characteristics and actual 3-month scores). The minimal clinically important difference (MCID) for ODI of 12.8 points and the substantial clinical benefit (SCB) for ODI of 18.8 points were used based on the previously published values. The concordance rate of achieving MCID and SCB for ODI at 3-and 12-months was computed. RESULTS The 3-month ODI scores differed from 12-month scores by an absolute difference of 11.9 ± 10.8, and predictive modeling estimations of 12-month ODI scores differed from actual 12-month scores by a mean (± SD) of 10.7 ± 9.0 points (p = 0.001). Sixty-four percent of patients (n = 1982) achieved an MCID for ODI at 3 months in comparison with 67% of patients (n = 2088) by 12 months; 51% (n = 1731) and 61% (n = 1860) of patients achieved SCB for ODI at 3 months and 12 months, respectively. Almost 20% of patients had ODI scores that varied at least 20 points (the point span of an ODI functional category) between actual 3- and 12-month values. In the aggregate analysis of achieving MCID, 77% of patients were concordant and 23% were discordant in achieving or not achieving

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.

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.

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

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.

Leuprolide Acetate 1-Month Depot for Central Precocious Puberty: Hormonal Suppression and Recovery

Directory of Open Access Journals (Sweden)

Neely EKirk

2011-01-01

Full Text Available Methods. This prospective US multicenter trial of leuprolide acetate 1-month depot (7.5–15 mg for central precocious puberty utilized an open-label treatment period, long-term follow-up, and adult callback. Forty-nine females Results. Subjects were treated for years. Mean peak GnRH-stimulated LH and FSH were prepubertal after the first dose and remained suppressed throughout treatment. During treatment, mean estradiol decreased to the limit of detection and mean testosterone decreased but remained above prepubertal norms. During posttreatment follow-up ( years, all patients achieved a pubertal hormonal response within 1 year and menses were reported in all females ≥12 years old. No impairment of reproductive function was observed at adulthood (mean age: 24.8 years.

[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.

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.

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

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.

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

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...

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

Science.gov (United States)

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.

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.

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

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

First human use of hybrid synthetic/biologic mesh in ventral hernia repair: a multicenter trial.

Science.gov (United States)

Bittner, James G; El-Hayek, Kevin; Strong, Andrew T; LaPinska, Melissa Phillips; Yoo, Jin S; Pauli, Eric M; Kroh, Matthew

2018-03-01

Mesh options for reinforcement of ventral/incisional hernia (VIH) repair include synthetic or biologic materials. While each material has known advantages and disadvantages, little is understood about outcomes when these materials are used in combination. This multicenter study reports on the first human use of a novel synthetic/biologic hybrid mesh (Zenapro ® Hybrid Hernia Repair Device) for VIH repair. This prospective, multicenter post-market clinical trial enrolled consecutive adults who underwent elective VIH repair with hybrid mesh placed in the intraperitoneal or retromuscular/preperitoneal position. Patients were classified as Ventral Hernia Working Group (VHWG) grades 1-3 and had clean or clean-contaminated wounds. Outcomes of ventral and incisional hernia were compared using appropriate parametric tests. In all, 63 patients underwent VIH repair with hybrid mesh. Most were females (54.0%), had a mean age of 54.8 ± 10.9 years and mean body mass index of 34.5 ± 7.8 kg/m 2 , and classified as VHWG grade 2 (87.3%). Most defects were midline (92.1%) with a mean area of 106 ± 155 cm 2 . Cases were commonly classified as clean (92.1%) and were performed laparoscopically (60.3%). Primary fascial closure was achieved in 82.5% with 28.2% requiring component separation. Mesh location was frequently intraperitoneal (69.8%). Overall, 39% of patients available for follow-up at 12 months suffered surgical site events, which were generally more frequent after incisional hernia repair. Of these, seroma (23.7%) was most common, but few (8.5%) required procedural intervention. Other surgical site events that required procedural intervention included hematoma (1.7%), wound dehiscence (1.7%), and surgical site infection (3.4%). Recurrence rate was 6.8% (95% CI 2.2-16.6%) at 12-months postoperatively. Zenapro ® Hybrid Hernia Repair Device is safe and effective in VHWG grade 1-2 patients with clean wounds out to 12 months. Short-term outcomes and recurrence rate

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.

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…

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...

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.

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

Science.gov (United States)

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

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.

Trajectories of health-related quality of life after stroke : results from a one-year prospective cohort study

NARCIS (Netherlands)

van Mierlo, Maria; van Heugten, Caroline; Post, Marcel W M; Hoekstra, Trynke; Visser-Meily, Anne

2018-01-01

PURPOSE: To identify trajectories of physical and psychosocial health-related quality of life (HRQoL) from two months to one-year post stroke and to determine the factors that are associated with trajectory membership. METHOD: Multicenter prospective cohort study in which 351 stroke patients were

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�

Efficacy and Safety of Monthly versus Quarterly Ranibizumab Treatment in Neovascular Age-related Macular Degeneration: The EXCITE Study

NARCIS (Netherlands)

Schmidt-Erfurth, Ursula; Eldem, Bora; Guymer, Robyn; Korobelnik, Jean-Franc̦ois; Schlingemann, Reinier O.; Axer-Siegel, Ruth; Wiedemann, Peter; Simader, Christian; Gekkieva, Margarita; Weichselberger, Andreas

2011-01-01

Objective: To demonstrate noninferiority of a quarterly treatment regimen to a monthly regimen of ranibizumab in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Design: A 12-month, multicenter, randomized, double-masked,

Triangular Titanium Implants for Minimally Invasive Sacroiliac Joint Fusion: A Prospective Study.

Science.gov (United States)

Duhon, Bradley S; Cher, Daniel J; Wine, Kathryn D; Kovalsky, Don A; Lockstadt, Harry

2016-05-01

Study Design Prospective multicenter single-arm interventional clinical trial. Objective To determine the degree of improvement in sacroiliac (SI) joint pain, disability related to SI joint pain, and quality of life in patients with SI joint dysfunction who undergo minimally invasive SI joint fusion using triangular-shaped titanium implants. Methods Subjects (n = 172) underwent minimally invasive SI joint fusion between August 2012 and January 2014 and completed structured assessments preoperatively and at 1, 3, 6, and 12 months postoperatively, including a 100-mm SI joint and back pain visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form-36 (SF-36), and EuroQOL-5D. Patient satisfaction with surgery was assessed at 6 and 12 months. Results Mean SI joint pain improved from 79.8 at baseline to 30.0 and 30.4 at 6 and 12 months, respectively (mean improvements of 49.9 and 49.1 points, p < 0.0001 each). Mean ODI improved from 55.2 at baseline to 32.5 and 31.4 at 6 and 12 months (improvements of 22.7 and 23.9 points, p < 0.0001 each). SF-36 physical component summary improved from 31.7 at baseline to 40.2 and 40.3 at 6 and 12 months (p < 0.0001). At 6 and 12 months, 93 and 87% of subjects, respectively, were somewhat or very satisfied and 92 and 91%, respectively, would have the procedure again. Conclusions Minimally invasive SI joint fusion resulted in improvement of pain, disability, and quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis and SI joint disruption.

Painful Memories: Reliability of Pain Intensity Recall at 3 Months in Senior Patients

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Raoul Daoust

2017-01-01

Full Text Available Background. Validity of pain recall is questioned in research. Objective. To evaluate the reliability of pain intensity recall for seniors in an emergency department (ED. Methods. This study was part of a prospective multicenter project for seniors (≥65 years old treated in an ED for minor traumatic injury. Pain intensity (0–10 numerical rating scale was evaluated at the initial ED visit, at one week (baseline, and 3 months. At three months, patients were asked to recall the pain intensity they had at baseline. Results. 482 patients were interviewed (mean age 76.6 years, SD ± 7.3 and 72.8% were female. Intraclass correlation coefficient between pain at baseline and its recall was 0.24 (95% CI: 0.14–0.33. Senior patients tended to overestimate their pain intensity by a mean of 1.2 (95% CI: 0.9–1.5 units. A stepwise multiple regression analysis showed that the variance of baseline pain recall at 3 months was explained by pain at ED visit (11%, pain at 3 months (7%, and pain at baseline (2%. Conclusion. The accuracy of pain intensity recall after three months is poor in seniors and seems to be influenced by the pain experienced at the time of injury.

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

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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.

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.

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.

Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy

Energy Technology Data Exchange (ETDEWEB)

Mariados, Neil, E-mail: nmariados@ampofny.com [Associated Medical Professionals of New York, Syracuse, New York (United States); Sylvester, John [21st Century Oncology, East Bradenton, Florida (United States); Shah, Dhiren [Western New York Urology Associates, Cancer Care of WNY, Cheektowaga, New York (United States); Karsh, Lawrence [The Urology Center of Colorado, Denver, Colorado (United States); Hudes, Richard [Chesapeake Urology Research Associates, The Prostate Center, Owings Mills, Maryland (United States); Beyer, David [Arizona Oncology Services Foundation, Phoenix, Arizona (United States); Kurtzman, Steven [Urological Surgeons of Northern California, Campbell, California (United States); Bogart, Jeffrey [The Research Foundation of State University of New York, SUNY Upstate Medical University, Syracuse, New York (United States); Hsi, R. Alex [Peninsula Cancer Center, Poulsbo, Washington (United States); Kos, Michael [Urology Nevada, Reno, Nevada (United States); Ellis, Rodney [University Hospitals Case Medical Center, Cleveland, Ohio (United States); Logsdon, Mark [Sutter Health Sacramento Sierra Region, Sutter Institute for Medical Research, Sacramento, California (United States); Zimberg, Shawn [Advanced Radiation Centers of New York, Lake Success, New York (United States); Forsythe, Kevin [Oregon Urology Institute, Springfield, Oregon (United States); Zhang, Hong [University of Rochester, Rochester, New York (United States); Soffen, Edward [CentraState Medical Center, Freehold, New Jersey (United States); Francke, Patrick [Carolina Regional Cancer Center, 21st Century Oncology, Myrtle Beach, South Carolina (United States); Mantz, Constantine [21st Century Oncology, Fort Meyers, Florida (United States); Rossi, Peter [Emory University, Atlanta, Georgia (United States); DeWeese, Theodore [The Johns Hopkins University, Baltimore, Maryland (United States); and others

2015-08-01

Purpose: Perirectal spacing, whereby biomaterials are placed between the prostate and rectum, shows promise in reducing rectal dose during prostate cancer radiation therapy. A prospective multicenter randomized controlled pivotal trial was performed to assess outcomes following absorbable spacer (SpaceOAR system) implantation. Methods and Materials: Overall, 222 patients with clinical stage T1 or T2 prostate cancer underwent computed tomography (CT) and magnetic resonance imaging (MRI) scans for treatment planning, followed with fiducial marker placement, and were randomized to receive spacer injection or no injection (control). Patients received postprocedure CT and MRI planning scans and underwent image guided intensity modulated radiation therapy (79.2 Gy in 1.8-Gy fractions). Spacer safety and impact on rectal irradiation, toxicity, and quality of life were assessed throughout 15 months. Results: Spacer application was rated as “easy” or “very easy” 98.7% of the time, with a 99% hydrogel placement success rate. Perirectal spaces were 12.6 ± 3.9 mm and 1.6 ± 2.0 mm in the spacer and control groups, respectively. There were no device-related adverse events, rectal perforations, serious bleeding, or infections within either group. Pre-to postspacer plans had a significant reduction in mean rectal V70 (12.4% to 3.3%, P<.0001). Overall acute rectal adverse event rates were similar between groups, with fewer spacer patients experiencing rectal pain (P=.02). A significant reduction in late (3-15 months) rectal toxicity severity in the spacer group was observed (P=.04), with a 2.0% and 7.0% late rectal toxicity incidence in the spacer and control groups, respectively. There was no late rectal toxicity greater than grade 1 in the spacer group. At 15 months 11.6% and 21.4% of spacer and control patients, respectively, experienced 10-point declines in bowel quality of life. MRI scans at 12 months verified spacer absorption. Conclusions: Spacer

Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study.

Science.gov (United States)

Steffen, Armin; Sommer, J Ulrich; Hofauer, Benedikt; Maurer, Joachim T; Hasselbacher, Katrin; Heiser, Clemens

2018-02-01

Upper airway stimulation (UAS) of the hypoglossal nerve has been implemented in the routine clinical practice for patients with moderate-to-severe obstructive sleep apnea (OSA) who could not adhere to continuous positive airway pressure. This study reports objective and patient-reported outcome after 12 months of implantation. Multicenter prospective single-arm study. Consecutive patients who received the UAS system (Inspire Medical Systems, Inc., Minneapolis, Minnesota, Maple Grove, MN, U.S.A.) were enrolled in three German centers. Key study exclusion criteria included body mass index > 35 kg/m 2 , apnea-hypopnea index (AHI)  65, or complete concentric collapse at the soft palate during sedated endoscopy. Data collection at 6- and 12-month visit include home sleep test and patient-reported outcome measures. Among the total of 60 participants, the median AHI reduced from 28.6 to 9.5 from baseline to 12 months. Patient-reported outcome measured in Epworth Sleepiness Scale and Functional Outcomes of Sleep Questionnaire both improved significantly from baseline to 12 months. The average usage time was 39.1 ± 14.9 hours per week among all participants based on recordings by the implanted device. One patient requested a removal of the device for cosmetic and other personal reasons and was completed without sequelae. This study supported that UAS is a safe and effective treatment option for patients with OSA in routine clinical practice. 4. Laryngoscope, 128:509-515, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

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.

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.

Your Baby's Growth: 12 Months

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... 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 ...

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. ...

Depression and anxiety following hematopoietic stem cell transplantation

DEFF Research Database (Denmark)

Kuba, K; Esser, P; Mehnert, A

2017-01-01

In this prospective multicenter study, we investigated the course of depression and anxiety during hematopoietic stem cell transplantation (HSCT) until 5 years after transplantation adjusting for medical information. Patients were consulted before HSCT (n=239), at 3 months (n=150), 12 months (n=102...

The impact of GI events on persistence and adherence to osteoporosis treatment: 3-, 6-, and 12-month findings in the MUSIC-OS study.

Science.gov (United States)

Modi, A; Sen, S; Adachi, J D; Adami, S; Cortet, B; Cooper, A L; Geusens, P; Mellström, D; Weaver, J P; van den Bergh, J P; Keown, P; Sajjan, S

2018-02-01

The goal of this multinational, prospective, observational study was to examine the relationship between gastrointestinal (GI) events and self-reported levels of medication adherence and persistence in postmenopausal women. A total of 73.9% of patients remained on their osteoporosis (OP) therapy at month 12, although the presence of a GI event at baseline, month 3, and month 6 significantly reduced month 12 persistence among new users. The odds of a month-12 ADEOS score ≥ 20 were significantly lower among patients who experienced a GI event between baseline and month 6. The occurrence of GI events was observed to be associated with a lower likelihood of patient adherence and persistence to OP medication. This study examines the relationship between gastrointestinal (GI) events and self-reported adherence and persistence with initial osteoporosis (OP) therapy over the course of the first 12 months of treatment. The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study was a multinational, prospective, observational study examining the impact of GI events on OP management in postmenopausal women. Information regarding GI events was collected at the time of enrollment and at months 3, 6, and 12 of follow-up. Patients reported GI events and medication persistence and completed the 12-item Adherence Evaluation of Osteoporosis treatment (ADEOS) questionnaire. Multivariate logistic and general linear models examined the association between GI events at various time points and persistence and adherence at month 12. The study enrolled 2943 women; 22.8% were classified as new users of OP therapy and the remainder were considered experienced users. Across all patients, 68.1% reported GI events at baseline; by month 12, over 80% of subjects who completed follow-up reported at least one GI problem. The majority of patients (86.7%) were treated only with bisphosphonates at baseline. At month 12, 73.9% of patients remained on therapy

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.

Intraoperative photodynamic therapy of bladder cancer with alasens (results of multicenter trial

Directory of Open Access Journals (Sweden)

E. V. Filonenko

2014-01-01

Full Text Available The results of multicenter prospective trial for efficacy of combined modality treatment: transurethral resection (TUR + photodynamic therapy (PDT with alasens for bladder cancer are represented in the article. Trials were organized by Research Institute of Organic Intermediates and Dyes and conducted according to clinical protocol approved by Ministry of Health of Russia, at the sites of leading Russian cancer clinical centers. The trial included 45 subjects with verified diagnosis of non-muscle-invasive bladder cancer. Patients underwent TUR of bladder with simultaneous PDT as anti-relapse treatment. Alasens was administered to patients as intravesicular instillation of 3% solution in volume of 50 ml with 1.5–2h exposure (prior to TUR. TUR was performed after instillation. PDT session was conducted immediately after the completion of TUR on a single occasion by means of combined local irradiation on tumor bed with diffuse irradiation on whole urinary bladder mucosa (light dose of local irradiation – 100 J/cm2, diffuse irradiation – 20 J/cm2. Good tolerance of the treatment was noticed, there were no complications. Among 45 patients included in the trial, 35 (78% completed 12 month protocol follow-up without relapse. The recurrence of bladder tumor was registered in 10 (22% cases 6–12 months after TUR+PDT including 3 patients with recurrence 6 months after treatment, 3–9 months and 4–12 months. These patients underwent repeated TUR, whereafter their follow-up in the settings of the clinical trial was disposed. Thus, PDT with alasens after TUR allowed to decrease the recurrence rate of non-muscle-invasive bladder cancer for 1st year after treatment to 22% versus 40–80% for TUR as monotherapy according to literature data. The obtained results were comparable by efficiency with TUR combined with methods of adjuvant treatment for bladder tumors (the recurrence rates for 1-year follow-up after TUR+chemotherapy – 36–44%, after TUR

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.

A multicenter, randomized, double-blind, placebo-controlled, 6-month trial of bupropion hydrochloride sustained-release tablets as an aid to smoking cessation in hospital employees

DEFF Research Database (Denmark)

Dalsgareth, Oli Jacob; Hansen, Niels-Christian Gerner; Søes-Petersen, Ulrik

2004-01-01

Despite changes in smoking behavior, one-third of the Danish population continues to smoke. Many of these smokers are hospital employees. This 6-month, multicenter, parallel group, randomized, double-blind, placebo-controlled study evaluated treatment with bupropion hydrochloride sustained release...

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

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.

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)

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.)

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.)

Comparable Renal Function at 6 Months with Tacrolimus Combined with Fixed-Dose Sirolimus or MMF: Results of a Randomized Multicenter Trial in Renal Transplantation

Directory of Open Access Journals (Sweden)

Eveline Van Gurp

2010-01-01

Full Text Available In a multicenter trial, renal transplant recipients were randomized to tacrolimus with fixed-dose sirolimus (Tac/SRL, N = 318 or tacrolimus with MMF (Tac/MMF, N = 316. Targeted tacrolimus trough levels were lower in the Tac/SRL group after day 14. The primary endpoint was renal function at 6 months using creatinine clearance (Cockcroft-Gault and was comparable at 66.4 mL/min (SE 1.4 with Tac/SRL and at 65.2mL/min (SE 1.3 with Tac/MMF (completers. Biopsy-confirmed acute rejection was 15.1% (Tac/SRL and 12.3% (Tac/MMF. In both groups, graft survival was 93% and patient survival was 99.0%. Premature withdrawal due to an adverse event was twice as high in the Tac/SRL group, 15.1% versus 6.3%. Hypercholesterolemia incidence was higher with Tac/SRL (P30 consecutive days in previously nondiabetic patients was 17.8%, Tac/SRL, and 24.8%, Tac/MMF. Evaluation at 6 months showed comparable renal function using tacrolimus/sirolimus and tacrolimus/MMF regimens.

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

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.

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.

Comparison of Clinical Characteristics among Subtypes of Visual Symptoms in Patients with Transient Ischemic Attack: Analysis of the PROspective Multicenter registry to Identify Subsequent cardiovascular Events after TIA (PROMISE-TIA) Registry.

Science.gov (United States)

Tanaka, Koji; Uehara, Toshiyuki; Kimura, Kazumi; Okada, Yasushi; Hasegawa, Yasuhiro; Tanahashi, Norio; Suzuki, Akifumi; Nakagawara, Jyoji; Arii, Kazumasa; Nagahiro, Shinji; Ogasawara, Kuniaki; Uchiyama, Shinichiro; Matsumoto, Masayasu; Iihara, Koji; Toyoda, Kazunori; Minematsu, Kazuo

2018-06-01

A transient visual symptom (TVS) is a clinical manifestation of transient ischemic attack (TIA). The aim of this study was to investigate differences in clinical characteristics among subtypes of TVS using multicenter TIA registry data. Patients with TIA visiting within 7 days of onset were prospectively enrolled from 57 hospitals between June 2011 and December 2013. Clinical characteristics were compared between patients with 3 major subtypes of TVS (transient monocular blindness [TMB], homonymous lateral hemianopia [HLH], and diplopia). Of 1365 patients, 106 (7.8%) had TVS, including 40 TMB (38%), 34 HLH (32%), 17 diplopia (16%), and 15 others/unknown (14%). Ninety-one patients with 1 of the 3 major subtypes of TVS were included. Symptoms persisted on arrival in 12 (13%) patients. Isolated TVS was significantly more common in TMB than in HLH and diplopia (88%, 62%, and 0%, respectively; P TIA multicenter cohort. Some differences in clinical characteristics were found among subtypes of TVS. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

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

Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

Science.gov (United States)

Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

2017-01-01

The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

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

Retrofit Weight-Loss Outcomes at 6, 12, and 24 Months and Characteristics of 12-Month High Performers: A Retrospective Analysis.

Science.gov (United States)

Painter, Stefanie; Ditsch, Gary; Ahmed, Rezwan; Hanson, Nicholas Buck; Kachin, Kevin; Berger, Jan

2016-08-22

Obesity is the leading cause of preventable death costing the health care system billions of dollars. Combining self-monitoring technology with personalized behavior change strategies results in clinically significant weight loss. However, there is a lack of real-world outcomes in commercial weight-loss program research. Retrofit is a personalized weight management and disease-prevention solution. This study aimed to report Retrofit's weight-loss outcomes at 6, 12, and 24 months and characterize behaviors, age, and sex of high-performing participants who achieved weight loss of 10% or greater at 12 months. A retrospective analysis was performed from 2011 to 2014 using 2720 participants enrolled in a Retrofit weight-loss program. Participants had a starting body mass index (BMI) of >25 kg/m² and were at least 18 years of age. Weight measurements were assessed at 6, 12, and 24 months in the program to evaluate change in body weight, BMI, and percentage of participants who achieved 5% or greater weight loss. A secondary analysis characterized high-performing participants who lost ≥10% of their starting weight (n=238). Characterized behaviors were evaluated, including self-monitoring through weigh-ins, number of days wearing an activity tracker, daily step count average, and engagement through coaching conversations via Web-based messages, and number of coaching sessions attended. Average weight loss at 6 months was -5.55% for male and -4.86% for female participants. Male and female participants had an average weight loss of -6.28% and -5.37% at 12 months, respectively. Average weight loss at 24 months was -5.03% and -3.15% for males and females, respectively. Behaviors of high-performing participants were assessed at 12 months. Number of weigh-ins were greater in high-performing male (197.3 times vs 165.4 times, P=.001) and female participants (222 times vs 167 times, Pactivity tracker days and average steps per day were greater in high-performing females (304.7 vs

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

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...

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.

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

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.

LAP-BAND for BMI 30-40: 5-year health outcomes from the multicenter pivotal study.

Science.gov (United States)

Dixon, J B; Eaton, L L; Vincent, V; Michaelson, R

2016-02-01

We performed a 5-year multicenter study to evaluate the safety and effectiveness of the LAP-BAND System surgery (LBS) in patients with obesity with a body mass index (BMI) of 30-39.9 kg m(-)(2). This pivotal study was designed to support LBS application to the US Food and Drug Administration for broadening the indications for surgery and the lower BMI indication was approved with 1-year data in 2011, with the intention to complete the 5-year evaluation. To present broad health outcome data including weight change, patient reported outcomes, comorbidity change and complications during the 5-year study. The study was conducted at seven US private practice clinical trial sites. We enrolled 149 BMI 30-39.9 subjects into a 5-year, multicenter, longitudinal, prospective post-approval study. Data for those completing each time point are presented. The predefined target of at least 30% excess weight loss was achieved by more than 76% of subjects by 1-year and at every year thereafter during the 5-year study. Mean percentage weight loss at 5 years was 15.9±12.4%. Sustained weight loss was accompanied by sustained improvement in generic and weight-specific quality of life, symptoms of depression and the prevalence of binge-eating disorder. The number of subjects with normal fasting triglyceride, high-density lipoprotein cholesterol, plasma glucose and HbA1c increased significantly between baseline and 5 years. Fifty-four months after LBS implantation, the rate of device explants without replacement was 5.4%; however, the rate of explants increased to 12.1% by month 60 owing to no cost-elective band removals offered to subjects at study exit. No deaths or unanticipated adverse device effects were reported. The LBS is safe and effective for people with BMI 30-39.9 with demonstrated improvements in weight loss, comorbidities and quality of life, and with a low explant rate through 5 years following treatment.

Can the cerebroplacental ratio (CPR) predict intrapartum fetal compromise? : a prospective observational study

OpenAIRE

Page, Ann-Sophie; Page, Geert; Dehaene, Isabelle; Roets, Ellen; Roelens, Kristien

2017-01-01

Objective: To investigate the potential clinical use of serial fetal CPR measurements during the last month of pregnancy for the prediction of adverse perinatal outcome in unselected low-risk pregnancies. Methods: A multicenter prospective observational cohort study in 315 consecutively recruited low-risk pregnancies. All eligible pregnancies underwent serial sonographic evaluation of fetal weight and Doppler indices at two week intervals, from 36 weeks gestation until delivery. Data were ...

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results.

Science.gov (United States)

Zahnert, Thomas; Löwenheim, Hubert; Beutner, Dirk; Hagen, Rudolf; Ernst, Arneborg; Pau, Hans-Wilhelm; Zehlicke, Thorsten; Kühne, Hilke; Friese, Natascha; Tropitzsch, Anke; Lüers, Jan-Christoffer; Mlynski, Robert; Todt, Ingo; Hüttenbrink, Karl-Bernd

2016-01-01

To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction. Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients. A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery. © 2016 S. Karger AG, Basel.

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.

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

The impact of vegan diet on B-12 status in healthy omnivores: five-year prospective study.

Science.gov (United States)

Mądry, Edyta; Lisowska, Aleksandra; Grebowiec, Philip; Walkowiak, Jarosław

2012-04-02

There are no long-term prospective studies assessing the impact of the vegan diet on vitamin B-12 (B-12) status. Many vegans take B-12 supplements irregularly or refuse to adopt them at all, considering them to be "unnatural" products. The use of B-12 fortified food may be an alternative. Therefore, we aimed to estimate the long-term effect of a vegan diet on serum B-12 concentrations in healthy omnivore adults, comparing the influence of natural products consumption and B-12 fortified food. A five year prospective study was carried out comprising 20 omnivore healthy adult subjects, who moved to strict vegan diet for 5 years. Ten volunteers followed vegan diet based entirely on natural products, while the remaining ten subjects consumed food fortified in B-12. In all subjects serum vitamin B-12 concentration was determined before and 6, 12, 24 and 60 months after the implementation of the diet. A significant decrease (p vegan diet. However, observed changes were in fact limited to the subgroup consuming exclusively natural products (p vegan diet is associated with the risk of vitamin B-12 deficiency. B-12 fortified products might constitute a valuable alternative in vegans refusing to take vitamin supplements.

12 CFR 906.5 - Monthly interest rate survey.

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Monthly interest rate survey. 906.5 Section 906... OPERATIONS OPERATIONS Monthly Interest Rate Survey (MIRS) § 906.5 Monthly interest rate survey. The Finance... Board and is used for determining the movement of the interest rate on renegotiable-rate mortgages and...

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.

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.

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.

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.

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.

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....

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.

A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

Directory of Open Access Journals (Sweden)

Wen-Hong Lu

2014-06-01

Full Text Available Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV. IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487, IVD-B (n = 485 or NSV (n = 487 groups and underwent operation. Follow-up included visits at the 3 rd -6 th and 12 th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations and semen analysis. The subjects' partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV among the three groups (P > 0.05. The cumulative rates of complications at the 12 th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method.

A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

Science.gov (United States)

Lu, Wen-Hong; Liang, Xiao-Wei; Gu, Yi-Qun; Wu, Wei-Xiong; Bo, Li-Wei; Zheng, Tian-Gui; Chen, Zhen-Wen

2014-01-01

Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD) implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV). IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing) whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487), IVD-B (n = 485) or NSV (n = 487) groups and underwent operation. Follow-up included visits at the 3rd–6th and 12th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations) and semen analysis. The subjects’ partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV) among the three groups (P > 0.05). The cumulative rates of complications at the 12th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method. PMID:24589454

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.

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.

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.

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.

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.

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

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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.

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

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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.

Single-Chain Antibody Fragment VEGF Inhibitor RTH258 for Neovascular Age-Related Macular Degeneration

DEFF Research Database (Denmark)

Holz, Frank G; Dugel, Pravin U.; Weissgerber, Georges

2016-01-01

Purpose To assess the safety and efficacy of different doses of RTH258 applied as single intravitreal administration compared with ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (AMD). Design Six-month, phase 1/2, prospective, multicenter, double-masked, randomized...

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

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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.

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

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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…

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

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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

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

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.

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

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

Efficacy of Long-Term Oral Vitamin B12 Supplementation after Total Gastrectomy: Results from a Prospective Study

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Joana Moleiro

2017-11-01

Full Text Available Background/Objectives: Vitamin B12 (VB12 deficiency is a common complication after total gastrectomy which may be associated with megaloblastic anemia and potentially irreversible neurologic symptoms. Intramuscular supplementation of VB12 has been considered the standard treatment, although it is associated with high costs and patient discomfort. Patients/Methods: We performed a prospective uncontrolled study (ACTRN12614000107628 in order to evaluate the clinical and laboratory efficacy of long-term oral VB12 supplementation in patients submitted to total gastrectomy. All patients received daily oral VB12 (1 mg/day and were evaluated every 3 months (clinical and laboratory evaluation: hemoglobin, VB12, total iron, ferritin, and folate. Results: A total of 26 patients were included with a mean age of 64 years (29-79. Patients were included with a mean period of 65 months (3-309 after total gastrectomy. At inclusion time, 17/26 patients were under intramuscular VB12, and 9 had not started supplementation yet. There were normal serum VB12 levels in 25/26 patients (mean VB12 serum levels: 657 pg/mL. The mean follow-up period was 20 (8.5-28 months. During follow-up, all patients had normal VB12 levels and there was no need for intramuscular supplementation. The patient with low VB12 levels had an increase to adequate levels, which remained stable. There were no differences with statistical significance among VB12 levels at 6 (867 pg/mL, 12 (1,008 pg/mL, 18 (1,018 pg/mL, and 24 (1,061 pg/mL months. Iron and folate supplementation was necessary in 21 and 7 patients, respectively. Conclusions: Oral VB12 supplementation is effective and safe in patients who underwent total gastrectomy and should be considered the preferential form of supplementation.

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.

Risk of chronic anxiety in implantable defibrillator patients

DEFF Research Database (Denmark)

Pedersen, Susanne S.; den Broek, Krista C van; Theuns, Dominic A M J

2011-01-01

Little is known about the prevalence of chronic anxiety in patients with an implantable cardioverter defibrillator (ICD). In a multi-center, prospective study, we examined 1) the prevalence of chronic anxiety (i.e., patients anxious at implantation and 12 months), and 2) predictors of chronic...... anxiety....

Feeding Your 8- to 12-Month-Old

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... 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. ...

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 ...

A Multicenter Phase I/II Study of the BCNU Implant (Gliadel ® Wafer) for Japanese Patients with Malignant Gliomas

Science.gov (United States)

AOKI, Tomokazu; NISHIKAWA, Ryo; SUGIYAMA, Kazuhiko; NONOGUCHI, Naosuke; KAWABATA, Noriyuki; MISHIMA, Kazuhiko; ADACHI, Jun-ichi; KURISU, Kaoru; YAMASAKI, Fumiyuki; TOMINAGA, Teiji; KUMABE, Toshihiro; UEKI, Keisuke; HIGUCHI, Fumi; YAMAMOTO, Tetsuya; ISHIKAWA, Eiichi; TAKESHIMA, Hideo; YAMASHITA, Shinji; ARITA, Kazunori; HIRANO, Hirofumi; YAMADA, Shinobu; MATSUTANI, Masao

2014-01-01

Carmustine (BCNU) implants (Gliadel® Wafer, Eisai Inc., New Jersey, USA) for the treatment of malignant gliomas (MGs) were shown to enhance overall survival in comparison to placebo in controlled clinical trials in the United States and Europe. A prospective, multicenter phase I/II study involving Japanese patients with MGs was performed to evaluate the efficacy, safety, and pharmacokinetics of BCNU implants. The study enrolled 16 patients with newly diagnosed MGs and 8 patients with recurrent MGs. After the insertion of BCNU implants (8 sheets maximum, 61.6 mg BCNU) into the removal cavity, various chemotherapies (including temozolomide) and radiotherapies were applied. After placement, overall and progression-free survival rates and whole blood BCNU levels were evaluated. In patients with newly diagnosed MGs, the overall survival rates at 12 months and 24 months were 100.0% and 68.8%, and the progression-free survival rate at 12 months was 62.5%. In patients with recurrent MGs, the progression-free survival rate at 6 months was 37.5%. There were no grade 4 or higher adverse events noted due to BCNU implants, and grade 3 events were observed in 5 of 24 patients (20.8%). Whole blood BCNU levels reached a peak of 19.4 ng/mL approximately 3 hours after insertion, which was lower than 1/600 of the peak BCNU level recorded after intravenous injections. These levels decreased to less than the detection limit (2.00 ng/mL) after 24 hours. The results of this study involving Japanese patients are comparable to those of previous studies in the United States and Europe. PMID:24739422

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.

The filtering, clear-cornea diathermal keratostomy: a minor Danish multicenter study

DEFF Research Database (Denmark)

Kessing, S.V.; Nissen, O.I.; Thygesen, J.

2008-01-01

PURPOSE: Is the new micropenetrating, clear-cornea procedure, intrastromal diathermal keratostomy (IDK), an alternative to the intricate "modern trabeculectomy"? METHODS: Prospective multicenter study. Four surgeons from 4 Danish eye departments attended an IDK course and subsequently decided whe...

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

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).

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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.

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

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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

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

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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

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

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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.

Comparative Effectiveness of the Deqi Sensation and Non-Deqi by Moxibustion Stimulation: A Multicenter Prospective Cohort Study in the Treatment of Knee Osteoarthritis

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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.

The PANGAEA study design - a prospective, multicenter, non-interventional, long-term study on fingolimod for the treatment of multiple sclerosis in daily practice.

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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.

A Randomized Trial Comparing Part-time Patching with Observation for Intermittent Exotropia in Children 12 to 35 Months of Age.

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Mohney, Brian G; Cotter, Susan A; Chandler, Danielle L; Holmes, Jonathan M; Chen, Angela M; Melia, Michele; Donahue, Sean P; Wallace, David K; Kraker, Raymond T; Christian, Melanie L; Suh, Donny W

2015-08-01

To determine the effectiveness of part-time patching for treating intermittent exotropia (IXT) in young children. Multicenter, randomized clinical trial. Two hundred one children 12 to 35 months of age with untreated IXT meeting the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near, and (2) 15-prism diopter (Δ) or more exodeviation at distance or near by prism and alternate cover test (PACT) but at least 10 Δ exodeviation at distance by PACT. Participants were assigned randomly to either observation (no treatment for 6 months) or patching prescribed for 3 hours daily for 5 months, followed by 1 month of no patching. The primary outcome was deterioration, defined as constant exotropia measuring at least 10 Δ at distance and near or receipt of nonprotocol treatment for IXT. Of the 177 participants (88%) completing the 6-month primary outcome examination, deterioration occurred in 4.6% (4 of 87) of the participants in the observation group and in 2.2% (2 of 90) of the participants in the patching group (difference, 2.4%; P = 0.27; 95% confidence interval, -3.8% to +9.4%). Motor deterioration occurred in 2.3% (2 of 87) of the observation group and in 2.2% (2 of 90) of the patching group (difference, 0.08%; P = 0.55; 95% confidence interval, -5.8% to +6.1%). For the observation and patching groups, respectively, 6-month mean PACT measurements were 27.9 Δ versus 24.9 Δ at distance (P = 0.02) and 19.3 Δ versus 17.0 Δ at near (P = 0.10); 6-month mean exotropia control scores were 2.8 versus 2.3 points at distance (P = 0.02) and 1.4 versus 1.1 points at near (P = 0.26). Among children 12 to 35 months of age with previously untreated IXT, deterioration over 6 months was uncommon, with or without patching treatment. There was insufficient evidence to recommend part-time patching for the treatment of IXT in children in this age group. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier

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

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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.

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

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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.

The effect of 12-month dehydroepiandrosterone supplementation on the menstrual pattern, ovarian reserve markers, and safety profile in women with premature ovarian insufficiency.

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Wong, Queenie Ho Yan; Yeung, Tracy Wing Yee; Yung, Sofie Shuk Fei; Ko, Jennifer Ka Yee; Li, Hang Wun Raymond; Ng, Ernest Hung Yu

2018-03-09

To evaluate the effect of 12-month DHEA supplementation on menstrual pattern and ovarian reserve markers in women with premature ovarian insufficiency (POI) METHODS: This is a prospective observational study. Women with POI were given DHEA supplements (25 mg three times daily) for 12 months. Sonographic assessment for ovarian volume and antral follicle count (AFC) and serum measurement for anti-Mullerian hormone (AMH), follicle stimulating hormone (FSH), estradiol, testosterone, liver function, and hemoglobin level were performed at baseline and monthly for 13 months after the supplementation. Menstrual pattern, ovarian reserve markers, and side-effects were recorded. Between August 2011 and July 2014, 38 women with POI were recruited and 31 completed the study. The median age of women was 36 years, and the median baseline FSH and AMH concentrations were 82.2 IU/L and 0.01 ng/ml, respectively. No women had resumption of regular menstruation after DHEA supplementation. AMH, FSH, and AFC did not change significantly. No serious side effects were reported. Our results do not support any significant improvement in ovarian function by 12-month DHEA supplementation in women with POI.

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

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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.

Optical Coherence Tomography Substudy of A Prospective Multicenter Randomized Post-Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesions: TARGET All Comers.

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Baumbach, Andreas; Lansky, Alexandra J; Onuma, Yoshi; Asano, Taku; Johnson, Thomas; Anderson, Richard; Kiemeneij, Ferdinand; Zheng, Ming; Van Royen, Niels; Slagboom, Ton; Vlachojannis, Georg; Xu, Bo; Serruys, Patrick; Wijns, William

2018-06-12

Durable polymer drug-eluting stents (DP DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this Optical Coherence Tomography (OCT) sub-study was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (FIREHAWK®) (BP DES) versus the DP DES (XIENCE) at 90 days in an all comers patient population. The TARGET All Comers study is a prospective multicenter randomised post-market trial of 1656 patients randomised 1:1 to FIREHAWK or XIENCE at 21 centers in 10 European countries. The TARGET OCT sub-study enrolled 36 consecutive patients with 52 lesions at 6 centers proficient in OCT. Follow-up OCT was performed at 3 months or prior to revascularisation when occurring before the 3-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions, Firehawk, n=24; Xience, n=28), was not significantly different between groups (Firehawk 75.5μm vs Xience V 82.3 μm) meeting the primary endpoint of non-inferiority (Pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9% ± 0.3 vs 100% ± 0.1, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups. Based on OCT, the FIREHAWK BP DES has a similar healing response 3 months after implantation compared to the DP DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

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

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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°.

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

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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.

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

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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.

Cubital tunnel syndrome: comparative results of a multicenter study of 4 surgical techniques with a mean follow-up of 92 months.

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Bacle, G; Marteau, E; Freslon, M; Desmoineaux, P; Saint-Cast, Y; Lancigu, R; Kerjean, Y; Vernet, E; Fournier, J; Corcia, P; Le Nen, D; Rabarin, F; Laulan, J

2014-06-01

Cubital tunnel syndrome is the second most frequent entrapment syndrome. Physiopathology is mixed, and treatment options are multiple, none having yet proved superior efficacy. The present retrospective multicenter study compared results and rates of complications and recurrence between the 4 main cubital tunnel syndrome treatments, to identify trends and optimize outcome. Patients presenting with primary clinical cubital tunnel syndrome diagnosed on electroneuromyography were included and operated on using 1 of the following 4 techniques: open or endoscopic in situ decompression, or subcutaneous or submuscular anterior transposition. Four specialized upper-limb surgery centers participated, each systematically performing 1 of the above procedures. Subjective and objective results and rates of complications and recurrence were compared at end of follow-up. Five hundred and two patients were included and 375 followed up for a mean 92 months (range, 9-144 months); 103 were lost to follow-up and 24 died. Whichever the procedure, more than 90% of patients were cured or showed improvement. There was a single case of scar pain at end of follow-up, managed by endoscopic decompression; there were no other long-term complications. None of the 4 techniques aggravated symptoms. There were 6 recurrences by end of follow-up: 1 associated with open in situ decompression and 5 with submuscular transposition. Surgery was effective in treating cubital tunnel syndrome. Submuscular anterior transposition was associated with recurrence. In contrast to literature reports, subcutaneous anterior transposition, which is a reliable and valid technique, was not associated with a higher complication rate than in situ decompression. Level IV. Multicenter retrospective. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

[Use of itopride in the symptoms of functional dyspepsia in Russia: results of a phase IV prospective open-label multicenter clinical trial].

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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.

Quality of life and disability 12 months after surgery vs. conservative management for unruptured brain arteriovenous malformations: Scottish population-based and Australian hospital-based studies.

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O'Donnell, Joan Margaret; Al-Shahi Salman, Rustam; Manuguerra, Maurizio; Assaad, Nazih; Morgan, Michael Kerin

2018-03-01

Few data are available on disability and quality of life (QOL) after surgery versus conservative management for unruptured brain arteriovenous malformations (uAVMs). The aim of this study was to test the hypothesis that QOL and disability are worse after surgery ± preoperative embolisation for uAVM compared with conservative management. We included consecutive patients diagnosed with uAVM from a prospective population-based study in Scotland (1999-2003; 2006-2010) and a prospective hospital-based series in Australia (2011-2015). We assessed outcomes on the modified Rankin Scale (mRS) and the Short Form (SF)-36 at ~ 12 months after surgery or conservative treatment and compared these groups using continuous ordinal regression in the two cohorts separately. Surgery was performed for 29% of all uAVM cases diagnosed in Scotland and 84% of all uAVM referred in Australia. There was no statistically significant difference between surgery and conservative management at 12 months among 79 patients in Scotland (mean SF-36 Physical Component Score (PCS) 39 [SD 14] vs. 39 [SD 13]; mean SF-36 Mental Component Score (MCS) 38 [SD 14] vs. 39 [SD 14]; mRS > 1, 24 vs. 9%), nor among 37 patients in Australia (PCS 51 [SD 10] vs. 49 [SD 6]; MCS 48 [SD 12] vs. 49 [SD 10]; mRS > 1, 19 vs. 30%). In the Australian series, there was no statistically significant change in the MCS and PCS between baseline before surgery or conservative management and 12 months. We did not find a statistically significant difference between surgery ± preoperative embolisation and conservative management in disability or QOL at 12 months.

Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF).

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Angermann, Christiane E; Assmus, Birgit; Anker, Stefan D; Brachmann, Johannes; Ertl, Georg; Köhler, Friedrich; Rosenkranz, Stephan; Tschöpe, Carsten; Adamson, Philip B; Böhm, Michael

2018-05-19

Wireless monitoring of pulmonary artery (PA) pressures with the CardioMEMS HF™ system is indicated in patients with New York Heart Association (NYHA) class III heart failure (HF). Randomized and observational trials have shown a reduction in HF-related hospitalizations and improved quality of life in patients using this device in the United States. MEMS-HF is a prospective, non-randomized, open-label, multicenter study to characterize safety and feasibility of using remote PA pressure monitoring in a real-world setting in Germany, The Netherlands and Ireland. After informed consent, adult patients with NYHA class III HF and a recent HF-related hospitalization are evaluated for suitability for permanent implantation of a CardioMEMS™ sensor. Participation in MEMS-HF is open to qualifying subjects regardless of left ventricular ejection fraction (LVEF). Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy as tolerated. The study will enroll 230 patients in approximately 35 centers. Expected duration is 36 months (24-month enrolment plus ≥ 12-month follow-up). Primary endpoints are freedom from device/system-related complications and freedom from pressure sensor failure at 12-month post-implant. Secondary endpoints include the annualized rate of HF-related hospitalization at 12 months versus the rate over the 12 months preceding implant, and health-related quality of life. Endpoints will be evaluated using data obtained after each subject's 12-month visit. The MEMS-HF study will provide robust evidence on the clinical safety and feasibility of implementing haemodynamic monitoring as a novel disease management tool in routine out-patient care in selected European healthcare systems. ClinicalTrials.gov; NCT02693691.

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.

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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.

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

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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

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

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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.

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

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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

Targets for parathyroid hormone in secondary hyperparathyroidism: is a “one-size-fits-all” approach appropriate? A prospective incident cohort study

OpenAIRE

Laurain, Emmanuelle; Ayav, Carole; Erpelding, Marie-Line; Kessler, Michèle; Briançon, Serge; Brunaud, Laurent; Frimat, Luc

2014-01-01

Background Recommendations for secondary hyperparathyroidism (SHPT) consider that a “one-size-fits-all” target enables efficacy of care. In routine clinical practice, SHPT continues to pose diagnosis and treatment challenges. One hypothesis that could explain these difficulties is that dialysis population with SHPT is not homogeneous. Methods EPHEYL is a prospective, multicenter, pharmacoepidemiological study including chronic dialysis patients (≥3 months) with newly SHPT diagnosis, i.e. para...

Emotional and Social Development: 8 to 12 Months

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... 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 ...

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

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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

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

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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

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

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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

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

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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.

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

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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

Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial.

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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.

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.

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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

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

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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.

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

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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.

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

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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.

Novel 'heavy' dyes for retinal membrane staining during macular surgery: multicenter clinical assessment

NARCIS (Netherlands)

Veckeneer, Marc; Mohr, Andreas; Alharthi, Essam; Azad, Rajvardhan; Bashshur, Ziad F.; Bertelli, Enrico; Bejjani, Riad A.; Bouassida, Brahim; Bourla, Dan; Crespo, Iñigo Corcóstegui; Fahed, Charbel; Fayyad, Faisal; Mura, Marco; Nawrocki, Jerzy; Rivett, Kelvin; Scharioth, Gabor B.; Shkvorchenko, Dmitry O.; Szurman, Peter; van Wijck, Hein; Wong, Ian Y.; Wong, David S. H.; Frank, Johannes; Oellerich, Silke; Bruinsma, Marieke; Melles, Gerrit R. J.

2014-01-01

Purpose: To evaluate the feasibility of two novel heavy' dye solutions for staining the internal limiting membrane (ILM) and epiretinal membranes (ERMs), without the need for a prior fluid-air exchange, during macular surgery. Methods: In this prospective nonrandomized multicenter cohort study, the

Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial.

Science.gov (United States)

Voskanyan, Lilit; García-Feijoó, Julián; Belda, Jose I; Fea, Antonio; Jünemann, Anselm; Baudouin, Christophe

2014-02-01

Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain. In this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit. Sixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects. In this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.

[In hospital and mid-term outcome of patients with NIR stent implantation: multicenter ESPORT-NIR registry].

Science.gov (United States)

Iñiguez, A; García, E; Seabra, R; Bordes, P; Bethencourt, A; Rigla, J

2001-05-01

Despite improvements in the results and techniques of catheter-based revascularization, few studies have evaluated the clinical results of the application of new stent designs. We describe the in-hospital and mid-term outcome of patients undergoing a stent NIR implantation. At least 1 Stent NIR was implanted in 1.004 patients (1.136 lesions) recruited from 50 centers in an international, multicenter, prospective, registry (Spain and Portugal NIR stent registry). Inclusion criteria were objective coronary ischemia related to a severe de novo lesion or first restenosis in native vessels with a reference diameter >= 2.75 mm. The primary end-point was the incidence of major adverse cardiac events within the first 7 months of follow-up. The mean age of the patients was 60 years and 82% were male. Angioplasty was indicated due to unstable angina in 61% of the cases. Stent implantation was successfully achieved in 99.6%. Clinical success (angiographic success without in-hospital major events) was achieved in 98.6% of patients. The rate of angiographic restenosis (> 50% stenosis narrowing) was 16% (CI 95%; 11.7-21.2). The accumulated major cardiac adverse event rate at seven months of follow-up was 8.7%: death (0.9%), acute myocardial infarction (1.2%) and target lesion revascularization (6.6%). In the wide setting of the population included in the ESPORT-NIR registry, stent NIR implantation was a highly effective therapy with a good mid-term clinical and angiographic outcome.

Randomized comparison of renal denervation versus intensified pharmacotherapy including spironolactone in true-resistant hypertension: six-month results from the Prague-15 study.

Science.gov (United States)

Rosa, Ján; Widimský, Petr; Toušek, Petr; Petrák, Ondřej; Čurila, Karol; Waldauf, Petr; Bednář, František; Zelinka, Tomáš; Holaj, Robert; Štrauch, Branislav; Šomlóová, Zuzana; Táborský, Miloš; Václavík, Jan; Kociánová, Eva; Branny, Marian; Nykl, Igor; Jiravský, Otakar; Widimský, Jiří

2015-02-01

This prospective, randomized, open-label multicenter trial evaluated the efficacy of catheter-based renal denervation (Symplicity, Medtronic) versus intensified pharmacological treatment including spironolactone (if tolerated) in patients with true-resistant hypertension. This was confirmed by 24-hour ambulatory blood pressure monitoring after excluding secondary hypertension and confirmation of adherence to therapy by measurement of plasma antihypertensive drug levels before enrollment. One-hundred six patients were randomized to renal denervation (n=52), or intensified pharmacological treatment (n=54) with baseline systolic blood pressure of 159±17 and 155±17 mm Hg and average number of drugs 5.1 and 5.4, respectively. A significant reduction in 24-hour average systolic blood pressure after 6 months (-8.6 [95% cofidence interval: -11.8, -5.3] mm Hg; Pblood pressure (-12.4 [95% cofidence interval: -17.0, -7.8] mm Hg; Pblood pressure comparable with intensified pharmacotherapy. © 2014 American Heart Association, Inc.

Combined phacocanaloplasty for open-angle glaucoma and cataract: 12 months results

Directory of Open Access Journals (Sweden)

Genaidy MM

2017-12-01

Full Text Available Mahmoud Mohamed Genaidy, Hosny Ahmed Zein, Ahmed Mostafa Eid Department of Ophthalmology, Faculty of Medicine, Minia University, Minia, Egypt Purpose of the study: To evaluate efficacy, safety, and success rates of canaloplasty combined with phacoemulsification and intraocular lens implantation in patients with open-angle glaucoma (OAG and visually significant cataract.Patients and methods: A prospective interventional noncomparative case series carried out in Minia University Hospital from April 2015 to October 2016 on 20 eyes of 18 patients who had visually significant cataract and primary OAG. All the cases had combined phacocanaloplasty. Preoperative best-corrected visual acuity, intraocular pressure (IOP, and number of antiglaucoma medications were collected and compared to postoperative levels, and complications rates were recorded.Results: 20 eyes of 18 patients (5 males and 15 females, with a mean age 57.6 years (range 48–69 years, underwent phacocanaloplasty. Preoperative mean IOP was 25.20 ±1.009 mmHg. Postoperative IOP decreased to a mean of 14.20±0.9, 14.85±0.8, and 15.85±0.7 mmHG at 3, 6, and 12 months, respectively, with 37% reduction from preoperative IOP level at one year follow-up visit (P=0.0005. The number of antiglaucoma medications dropped from mean of 1.55 preoperatively to 0.35 postoperatively. LogMAR of best-corrected visual acuity improved from 0.6950±0.07 preoperatively to 0.3670±0.056, 0.3460±0.056, and 0.03370±0.052 at 3, 6, and 12 months postoperatively (P=0.0005. Complications were limited to mild hyphemia (one case, mild corneal edema (one case, and mild inflammatory membrane (one case that resolved in the first week after surgery.Conclusion: Canaloplasty combined with clear corneal phacoemulsification and intraocular lens implantation may be a safe and effective procedure to lower IOP in adult patients with OAG and visually significant cataract. Keywords: cataract, glaucoma, phacoemulsification

MO-DE-207B-11: Reliability of PET/CT Radiomics Features in Functional and Morphological Components of NSCLC Lesions: A Repeatability Analysis in a Prospective Multicenter Cohort

Energy Technology Data Exchange (ETDEWEB)

Desseroit, M [INSERM, LaTIM UMR 1101, Brest (France); EE DACTIM, CHU de Poitiers, Poitiers (France); Tixier, F; Cheze Le Rest, C [EE DACTIM, CHU de Poitiers, Poitiers (France); Majdoub, M; Visvikis, D; Hatt, M [INSERM, LaTIM UMR 1101, Brest (France); Weber, W [Memorial Sloan Kettering Cancer Center, New-york, NY (United States); Siegel, B [Washington University School of Medicine, St Louis, MO (United States)

2016-06-15

Purpose: The goal of this study was to evaluate the repeatability of radiomics features (intensity, shape and heterogeneity) in both PET and low-dose CT components of test-retest FDG-PET/CT images in a prospective multicenter cohort of 74 NSCLC patients from ACRIN 6678 and a similar Merck trial. Methods: Seventy-four patients with stage III-IV NCSLC were prospectively included. The primary tumor and up to 3 additional lesions per patient were analyzed. The Fuzzy Locally Adaptive Bayesian algorithm was used to automatically delineate metabolically active volume (MAV) in PET. The 3D SlicerTM software was exploited to delineate anatomical volumes (AV) in CT. Ten intensity first-order features, as well as 26 textural features and four 3D shape descriptors were calculated from tumour volumes in both modalities. The repeatability of each metric was assessed by Bland-Altman analysis. Results: One hundred and five lesions (primary tumors and nodal or distant metastases) were delineated and characterized. The MAV and AV determination had a repeatability of −1.4±11.0% and −1.2±18.7% respectively. Several shape and heterogeneity features were found to be highly or moderately repeatable (e.g., sphericity, co-occurrence entropy or intensity size-zone matrix zone percentage), whereas others were confirmed as unreliable with much higher variability (more than twice that of the corresponding volume determination). Conclusion: Our results in this large multicenter cohort with more than 100 measurements confirm the PET findings in previous studies (with <30 lesions). In addition, our study is the first to explore the repeatability of radiomics features in the low-dose CT component of PET/CT acquisitions (previous studies considered dosimetry CT, CE-CT or CBCT). Several features were identified as reliable in both PET and CT components and could be used to build prognostic models. This work has received a French government support granted to the CominLabs excellence laboratory

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...

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.

Prognostic Factors Toward Clinically Relevant Radiographic Progression in Patients With Rheumatoid Arthritis in Clinical Practice: A Japanese Multicenter, Prospective Longitudinal Cohort Study for Achieving a Treat-to-Target Strategy.

Science.gov (United States)

Koga, Tomohiro; Okada, Akitomo; Fukuda, Takaaki; Hidaka, Toshihiko; Ishii, Tomonori; Ueki, Yukitaka; Kodera, Takao; Nakashima, Munetoshi; Takahashi, Yuichi; Honda, Seiyo; Horai, Yoshiro; Watanabe, Ryu; Okuno, Hiroshi; Aramaki, Toshiyuki; Izumiyama, Tomomasa; Takai, Osamu; Miyashita, Taiichiro; Sato, Shuntaro; Kawashiri, Shin-Ya; Iwamoto, Naoki; Ichinose, Kunihiro; Tamai, Mami; Origuchi, Tomoki; Nakamura, Hideki; Aoyagi, Kiyoshi; Eguchi, Katsumi; Kawakami, Atsushi

2016-04-01

To determine prognostic factors of clinically relevant radiographic progression (CRRP) in patients with rheumatoid arthritis (RA) in clinical practice.We performed a multicenter prospective study in Japan of biological disease-modifying antirheumatic drug (bDMARD)-naive RA patients with moderate to high disease activity treated with conventional synthetic DMARDs (csDMARDs) at study entry. We longitudinally observed 408 patients for 1 year and assessed disease activity every 3 months. CRRP was defined as yearly progression of modified total Sharp score (mTSS) > 3.0 U. We also divided the cohort into 2 groups based on disease duration (<3 vs ≥3 years) and performed a subgroup analysis.CRRP was found in 10.3% of the patients. A multiple logistic regression analysis revealed that the independent variables to predict the development of CRRP were: CRP at baseline (0.30 mg/dL increase, 95% confidence interval [CI] 1.01-1.11), time-integrated Disease Activity Score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) during the 1 year postbaseline (12.4-unit increase, 95%CI 1.17-2.59), RA typical erosion at baseline (95%CI 1.56-21.1), and the introduction of bDMARDs (95%CI 0.06-0.38). The subgroup analysis revealed that time-integrated DAS28-ESR is not a predictor whereas the introduction of bDMARDs is a significant protective factor for CRRP in RA patients with disease duration <3 years.We identified factors that could be used to predict the development of CRRP in RA patients treated with DMARDs. These variables appear to be different based on the RA patients' disease durations.

Research priorities for a multi-center child abuse pediatrics network - CAPNET.

Science.gov (United States)

Lindberg, Daniel M; Wood, Joanne N; Campbell, Kristine A; Scribano, Philip V; Laskey, Antoinette; Leventhal, John M; Pierce, Mary Clyde; Runyan, Desmond K

2017-03-01

Although child maltreatment medical research has benefited from several multi-center studies, the new specialty of child abuse pediatrics has not had a sustainable network capable of pursuing multiple, prospective, clinically-oriented studies. The Child Abuse Pediatrics Network (CAPNET) is a new multi-center research network dedicated to child maltreatment medical research. In order to establish a relevant, practical research agenda, we conducted a modified Delphi process to determine the topic areas with highest priority for such a network. Research questions were solicited from members of the Ray E. Helfer Society and study authors and were sorted into topic areas. These topic areas were rated for priority using iterative rounds of ratings and in-person meetings. The topics rated with the highest priority were missed diagnosis and selected/indicated prevention. This agenda can be used to target future multi-center child maltreatment medical research. Copyright © 2017 Elsevier Ltd. All rights reserved.

A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study

DEFF Research Database (Denmark)

Jensen, Janet F.; Egerod, Ingrid; Bestle, Morten H.

2016-01-01

and December 2015, at ten intensive care units (ICUs) in Denmark. We randomly assigned 386 adult patients (≥18 years) after receiving mechanical ventilation (≥48 h) to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC......Purpose: The aim of this randomized controlled trial (RCT) was to test the effectiveness of a post-ICU recovery program compared to standard care during the first year after ICU discharge. Methods: A pragmatic, non-blinded, multicenter, parallel-group RCT was conducted between December 2012......). Primary outcome was health-related quality of life (HRQOL) at 12 months. Secondary outcomes were sense of coherence (SOC), anxiety, depression, and posttraumatic stress disorder (PTSD) assessed at 3 and 12 months after ICU discharge including utilization of healthcare services at 12 months. Results: At 12...

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

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

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.

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.

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.

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.

Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain

Science.gov (United States)

Tennfjord, Merete Kolberg; Hilde, Gunvor; Ellström-Engh, Marie; Bø, Kari

2016-01-01

Background/aim Diastasis recti abdominis (DRA) is defined as a separation of the 2 muscle bellies of rectus abdominis. To date there is scant knowledge on prevalence, risk factors, and consequences of the condition. The present study aimed to investigate the prevalence of DRA during pregnancy and post partum, presence of possible risk factors, and the occurrence of lumbopelvic pain among women with and without DRA. Methods This prospective cohort study followed 300 first-time pregnant women from pregnancy till 12 months post partum. Data were collected by electronic questionnaire and clinical examinations. DRA was defined as a palpated separation of ≥2 fingerbreadths either 4.5 cm above, at or 4.5 cm below the umbilicus. Women with and without DRA were compared with independent samples Student's t-test and χ2/Fisher exact test, and OR with significance level >0.05. Results Prevalence of DRA was 33.1%, 60.0%, 45.4%, and 32.6% at gestation week 21, 6 weeks, 6 months and 12 months post partum, respectively. No difference in risk factors was found when comparing women with and without DRA. OR showed a greater likelihood for DRA among women reporting heavy lifting ≥20 times weekly (OR 2.18 95% CI 1.05 to 4.52). There was no difference in reported lumbopelvic pain (p=0.10) in women with and without DRA. Conclusions Prevalence of mild DRA was high both during pregnancy and after childbirth. Women with and without DRA reported the same amount of lumbopelvic pain 12 months post partum. PMID:27324871

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

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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.

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

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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.

ABCD3-I score and the risk of early or 3-month stroke recurrence in tissue- and time-based definitions of TIA and minor stroke.

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Mayer, Lukas; Ferrari, Julia; Krebs, Stefan; Boehme, Christian; Toell, Thomas; Matosevic, Benjamin; Tinchon, Alexander; Brainin, Michael; Gattringer, Thomas; Sommer, Peter; Thun, Peter; Willeit, Johann; Lang, Wilfried; Kiechl, Stefan; Knoflach, Michael

2018-03-01

Changing definition of TIA from time to a tissue basis questions the validity of the well-established ABCD3-I risk score for recurrent ischemic cerebrovascular events. We analyzed patients with ischemic stroke with mild neurological symptoms arriving TIA or minor stroke, in the prospective multi-center Austrian Stroke Unit Registry. Patients were retrospectively categorized according to a time-based (symptom duration below/above 24 h) and tissue-based (without/with corresponding brain lesion on CT or MRI) definition of TIA or minor stroke. Outcome parameters were early stroke during stroke unit stay and 3-month ischemic stroke. Of the 5237 TIA and minor stroke patients with prospectively documented ABCD3-I score, 2755 (52.6%) had a TIA by the time-based and 2183 (41.7%) by the tissue-based definition. Of the 2457 (46.9%) patients with complete 3-month followup, corresponding numbers were 1195 (48.3%) for the time- and 971 (39.5%) for the tissue-based definition of TIA. Early and 3-month ischemic stroke occurred in 1.1 and 2.5% of time-based TIA, 3.8 and 5.9% of time-based minor stroke, 1.2 and 2.3% of tissue-based TIA as well as in 3.1 and 5.5% of tissue-based minor stroke patients. Irrespective of the definition of TIA and minor stroke, the risk of early and 3-month ischemic stroke steadily increased with increasing ABCD3-I score points. The ABCD3-I score performs equally in TIA patients in tissue- as well as time-based definition and the same is true for minor stroke patients.

Simplified Therapeutic Intervention Scoring System : The TISS-28 items - Results from a multicenter study

NARCIS (Netherlands)

Miranda, DR; deRijk, A; Schaufeli, W

Objectives: To validate a simplified version of the Therapeutic Intervention Scoring System, the TISS-28, and to determine the association of TISS-28 with the time spent on scored and nonscored nursing activities. Design: Prospective, multicenter study. Setting: Twenty-two adult medical, surgical,

Child and adolescent internalizing and externalizing problems 12 months postburn: the potential role of preburn functioning, parental posttraumatic stress, and informant bias.

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Egberts, Marthe R; van de Schoot, Rens; Boekelaar, Anita; Hendrickx, Hannelore; Geenen, Rinie; Van Loey, Nancy E E

2016-07-01

Adjustment after pediatric burn injury may be a challenge for children as well as their parents. This prospective study examined associations of internalizing and externalizing problems in children and adolescents 12 months postburn with preburn functioning, and parental acute and chronic posttraumatic stress symptoms (PTSS) from different perspectives. Child, mother, and father reports of 90 children (9-18 years), collected within the first month and 12 months postburn, were analyzed. Results indicated that overall, child and parental appraisals of pre- and postburn behavioral problems were not significantly different from reference data. Rates of (sub)clinical postburn behavioral problems ranged from 6 to 17 %, depending on the informant. Pre- and postburn behavioral problems were significantly related, but only from the parents' perspective. Path models showed an association between parental PTSS 12 months postburn and parental reports of child internalizing problems, as well as a significant indirect relationship from parental acute stress symptoms via PTSS 12 months postburn. Notably, no associations between parental PTSS and child reports of postburn behavioral problems were found. In conclusion, parental observations of child externalizing problems appear to be influenced by their perspectives on the child's preburn functioning, while parental observations of internalizing problems are also related to long-term parental PTSS. However, these factors seem of no great value in predicting behavioral problems from the child's perspective, suggesting substantial informant deviations. To optimize adjustment, clinical burn practice is recommended to adopt a family perspective including parent perception of preburn functioning and parental PTSS in assessment and intervention.

Costs of infertility treatment: Results from an 18-month prospective cohort study

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Katz, Patricia; Showstack, Jonathan; Smith, James F.; Nachtigall, Robert D.; Millstein, Susan G.; Wing, Holly; Eisenberg, Michael L.; Pasch, Lauri A.; Croughan, Mary S.; Adler, Nancy

2010-01-01

Objectives To examine resource use (costs) by women presenting for infertility evaluation and treatment over 18 months, regardless of treatment pursued. Design Prospective cohort study in which women were followed for 18 months. Setting Eight infertility practices. Patients 398 women recruited from infertility practices. Data collection Women completed interviews and questionnaires at baseline, and after 4, 10, and 18 months of follow-up. Medical records were abstracted after 18 months to obtain details of services used. Main outcome measures Per-person and per-successful-outcome costs Results Treatment groups were defined as highest intensity treatment use. 20% of women did not pursue cycle-based treatment; about half pursued in-vitro fertilization (IVF). Median per-person costs ranged from $1,182 for medications only, to $24,373 and $38,015 for IVF and IVF-donor egg groups, respectively. Estimates of costs of successful outcomes (delivery or ongoing pregnancy by 18 months) were higher – $61,377 for IVF, for example – reflecting treatment success rates. Within the timeframe of the study, costs were not significantly different for women who were successful and women who were not. Conclusions While individual patient costs vary, these cost estimates developed from actual patient treatment experiences may provide patients with realistic estimates to consider when initiating infertility treatment. PMID:21130988

Quality of life in children three and nine months after discharge from a paediatric intensive care unit: a prospective cohort study

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Bos Albert P

2008-03-01

Full Text Available Abstract Background Improved survival in children with critical illnesses has led to new disease patterns. As a consequence evaluation of the well being of survivors of Pediatric Intensive Care Units (PICU has become important. Outcome assessment should therefore consist of evaluation of morbidity, functional health and Health Related Quality of Life (HRQoL. Awareness of HRQoL consequences and physical sequelae could lead to changes in support during the acute phase and thereafter. The aim of this study was to evaluate HRQoL in PICU survivors. Methods Prospective follow-up study three and nine months after discharge from a 14-bed tertiary PICU. Eighty-one of 142 eligible, previously healthy children were included from December 2002 through October 2005. HRQoL was assessed with the TNO-AZL Preschool Children Quality of Life Questionnaire (TAPQOL-PF for children aged 1 to 6 years of age, the TNO-AZL Children's Quality of Life Questionnaire Parent Form (TACQOL-PF for children aged 6 to 12 years of age, and the TNO-AZL Children's Quality of Life Questionnaire Child Form (TACQOL-CF for children aged 8 to 15 years of age. The studied patients were compared with age appropriate normative data using non-parametric tests and effect sizes. Results Thirty-one and 27 children, and 55 and 50 parents completed questionnaires respectively three and nine months after discharge. In 1–6 year old children parents reported more lung problems (3 and 9 months, worse liveliness (9 months and better appetite and problem behaviour (3 months; in 6–12 year old children parents reported worse motor functioning (3 months; and 12–15 year old adolescents reported worse motor functioning (3 months. Large effect sizes indicating clinical significant differences in HRQoL with healthy control subjects were found on more domains. Conclusion In this small group of PICU survivors differences in HRQoL with the normative population exist three and nine months after discharge

Prediction of motivational impairment: 12-month follow-up of the randomized-controlled trial on extended early intervention for first-episode psychosis.

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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.

Second-generation antipsychotic use in children and adolescents: a six-month prospective cohort study in drug-naïve patients.

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Arango, Celso; Giráldez, Miriam; Merchán-Naranjo, Jessica; Baeza, Inmaculada; Castro-Fornieles, Josefina; Alda, Jose-Angel; Martínez-Cantarero, Carmen; Moreno, Carmen; de Andrés, Pilar; Cuerda, Cristina; de la Serna, Elena; Correll, Christoph U; Fraguas, David; Parellada, Mara

2014-11-01

To assess weight and metabolic effects of 6 months of treatment with second-generation antipsychotics in naïve/quasi-naïve youths. This study looked at a nonrandomized, naturalistic, multicenter, inception cohort study of 279 patients aged 4 to 17 years (mean = 14.6 ± 2.9 years). Of those, 248 (88.8%) received a single antipsychotic (risperidone, olanzapine, or quetiapine) and completed 2 visits, and 178 (63.8%) completed the 6-month follow-up. Patients had schizophrenia-spectrum disorders (44.5%), mood-spectrum disorders (23.2%), disruptive behavioral disorders (17.3%), or other disorders (15.1%). Fifteen age- and gender-matched, healthy, nonmedicated individuals served as a comparison group. From baseline to 1 month, 3 months, and 6 months, all anthropometric measures increased significantly with each antipsychotic, that is, 6-month changes with risperidone (n = 157; 7.1 kg and 0.66 body mass index [BMI] z score), olanzapine (n = 44; 11.5 kg and 1.08 BMI z score), and quetiapine (n = 47; 6.3 kg and 0.54 BMI z score), but not in healthy control participants (-0.11 kg and 0.006 BMI z score). Fasting metabolic parameters increased significantly with risperidone (glucose [3.8] mg/dL, insulin [4.9] mU/L, homeostasis model assessment of insulin resistance [HOMA-IR: 1.2], triglycerides [15.6] mg/dL), and olanzapine (glucose [5.0] mg/dL, total cholesterol [21.2] mg/dL, and low-density lipoprotein cholesterol [44.6] mg/dL), but not with quetiapine or in healthy control participants. The percentage of research participants considered to be "at risk of adverse health outcome" increased during the 6 months from 8.9% to 29.2% for risperidone (p < .0001), 6.8% to 38.1% for olanzapine (p < .0001), and 6.3% to 4.0% for quetiapine (p = .91). Olanzapine, quetiapine, and risperidone increase body weight but have different cardiometabolic side effect profiles and different temporal side effect patterns. Copyright © 2014 American Academy of Child and Adolescent

MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.

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Staats, Peter S; Benyamin, Ramsin M

2016-02-01

Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Prospective, multi-center, randomized controlled clinical trial. Twenty-six US interventional pain management centers. To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each

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.

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

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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

Safety of Percutaneous Patent Ductus Arteriosus Closure: An Unselected Multicenter Population Experience

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El‐Said, Howaida G.; Bratincsak, Andras; Foerster, Susan R.; Murphy, Joshua J.; Vincent, Julie; Holzer, Ralf; Porras, Diego; Moore, John; Bergersen, Lisa

2013-01-01

Background The technique and safety of transcatheter patent ductus arteriosus (PDA) closure have evolved during the past 20 years. We sought to report a multicenter experience of PDA closure with a focus on the rate of adverse events (AE) and a review of institutional practice differences. Methods and Results Outcome data on transcatheter PDA closure were collected at 8 centers prospectively using a multicenter registry (Congenital Cardiac Catheterization Project on Outcome Registry). Between February 2007 and June 2010, 496 PDA closures were recorded using a device in 338 (68%) or coils in 158 (32%). Most patients had an isolated PDA (90%). Fifty percent of patients were between 6 months and 3 years old, with only 40 patients (8%) closure and 1 mm (range 0.5 to 6 mm; IQR 1 to 2 mm) for coil closure (P2 mm (all P1.5 mm. In 9% of cases (n=46), an AE occurred; however, only 11 (2%) were classified as high severity. Younger age was associated with a higher AE rate. Coil‐related AEs were more common than device‐related AEs (10% versus 2%, Pclosure in the present era has a very low rate of complications, although these are higher in younger children. Technical intervention‐related events were more common in coil procedures compared with device procedures. For PDAs ≤2.5 mm in diameter, institutional differences in preference for device versus coil exist. PMID:24284214

Determinants of developmental delay in infants aged 12 months.

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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.

MiDAS I (mild Decompression Alternative to Open Surgery): a preliminary report of a prospective, multi-center clinical study.

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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

Feasibility of a 12-month-exercise intervention during and after radiation and chemotherapy in cancer patients: impact on quality of life, peak oxygen consumption, and body composition.

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Grabenbauer, Alexander; Grabenbauer, Andrea J; Lengenfelder, Rosa; Grabenbauer, Gerhard G; Distel, Luitpold V

2016-03-16

Accumulating evidence suggests that exercise is effective in treating many of the acute and chronic side effects of anti-cancer therapy. A recent meta-analysis supported the use of exercise to prevent or treat fatigue and lymphoedema and to improve functional status in breast cancer patients. This trial was intended as a controlled, prospective feasibility study evaluating the impact of physical exercise (PE) in cancer patients during and after treatment with radio- and chemotherapy. Inclusion criteria were previous or ongoing treatment for cancer, motivation for PE of 0.5-1hour duration at least twice weekly for at least 3 months. Continuation of PE was encouraged thereafter. Every three months the following endpoints were assessed: Peak oxygen consumption as measured by supervised cardiopulmonary exercise test, body composition and quality of life. A total of 45 patients were included with a median age of 49 years. Forty were female and five male. Cancer types were: Breast cancer (n = 30/67 %), gastrointestinal cancer (n = 5/12 %), other types (n = 10/22 %). Thirty-eight (84 %) of the patients were included during curative treatment of their disease. Seven (16 %) were considered palliative. Adherence to the PE-programme longer than 6 months was noted for 41/45 (91 %) of the patients. Intensity of PE was thrice weekly in 32/45 (71 %), twice weekly in 11/45 (24 %). Two of 45 patients (5 %) had no PE. Mean peak oxygen consumption increased from 18.8 ± 5.6 ml/min/kg to 20.5 ± 3 ml/min/kg and 19.9 ± 4.7 ml/min/kg at 3 months (p = 0.005) and 12 months (p = 0.003), respectively. Median fat mass decreased from 30.7 ± 15 kg to 28.9 ± 15 kg and 29.5 ± 13 kg at 3 months (p = 0.001) and 12 months (p = 0.017), respectively. Global health status scores increased from a median baseline value of 54.9 ± 16.3 to 66.4 ± 14 % and 68.0 ± 20.3 % at 3 months (p = 0.001) and 12 months (p = 0.002), respectively. This exercise programme in cancer patients with 2-3 weekly

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

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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.

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

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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.

Individualized Ranibizumab Regimen Driven by Stabilization Criteria for Central Retinal Vein Occlusion

DEFF Research Database (Denmark)

Larsen, Michael; Waldstein, Sebastian M; Boscia, Francesco

2016-01-01

ischemia (exploratory analysis). RESULTS: At baseline, the mean BCVA was 53.0 letters and mean CRVO duration was 8.9 months (median, 2.4 months). Ranibizumab 0.5-mg treatment resulted in a statistically significant mean gain in BCVA from baseline at month 12 of 12.3 letters (standard deviation [SD], 16......PURPOSE: To assess the 12-month efficacy and safety profile of an individualized regimen of ranibizumab 0.5 mg driven by stabilization criteria in patients with macular edema secondary to central retinal vein occlusion (CRVO). DESIGN: A 24-month, prospective, open-label, single-arm, multicenter...... study. PARTICIPANTS: Three hundred fifty-seven patients. METHODS: Patients were treated with monthly ranibizumab 0.5-mg injections (minimum of 3 injections) until stable visual acuity (VA) was maintained for 3 consecutive months. Thereafter, ranibizumab 0.5 mg was dosed as needed if monthly monitoring...

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.

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

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

The Use of the OMERACT Ultrasound Tenosynovitis Scoring System in Multicenter Clinical Trials.

Science.gov (United States)

Ammitzbøll-Danielsen, Mads; Østergaard, Mikkel; Naredo, Esperanza; Iagnocco, Annamaria; Möller, Ingrid; D'Agostino, Maria-Antonietta; Gandjbakhch, Frédérique; Terslev, Lene

2018-02-01

To test the sensitivity to change of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) ultrasound (US) scoring system for tenosynovitis when applied in a multicenter design. RA patients with US-verified tenosynovitis were recruited when scheduled for treatment intensification. Tenosynovitis was assessed at baseline, and 3 and 6 months followup, using the semiquantitative OMERACT scoring system. Expressed in median (25th; 75th percentiles), the overall greyscale and Doppler score decreased significantly from baseline at 4 (2; 7) and 3 (2; 6), to 6 months at 2 (0; 3) and 0 (0; 1, p The OMERACT US scoring system for tenosynovitis showed high responsiveness, supporting its use for diagnosing and monitoring tenosynovitis in multicenter trials.

Software-based evaluation of toric IOL orientation in a multicenter clinical study.

Science.gov (United States)

Kasthurirangan, Sanjeev; Feuchter, Lucas; Smith, Pamela; Nixon, Donald

2014-12-01

To evaluate the rotational stability of a new one-piece hydrophobic acrylic toric intraocular lens (IOL) using a custom-developed software for analysis of slit-lamp photographs. In a prospective, multicenter study, 174 eyes were implanted with the TECNIS Toric IOL (Abbott Medical Optics, Inc., Santa Ana, CA). A custom-developed software was used to analyze high-resolution slit-lamp photographs of 156 eyes taken at day 1 (baseline) and 1, 3, and 6 months postoperatively. The software uses iris and sclera landmarks to align the baseline image and later images for comparison. Validation of software was performed through repeated analyses of protractor images rotated from 0.1° to 10.0° and randomly selected photographs of 20 eyes. Software validation showed precision (repeatability plus reproducibility variation) of 0.02° using protractor images and 2.22° using slit-lamp photographs. Good quality slit-lamp images and clear landmarks were necessary for precise measurements. At 6 months, 94.2% of eyes had 5° or less change in IOL orientation versus baseline; only 2 eyes (1.4%) had axis shift greater than 30°. Most eyes were within 5° or less of rotation between 1 and 3 months (92.9%) and 3 and 6 months (94.1%). Mean absolute axis change (± standard deviation) from 1 day to 6 months was 2.70° ± 5.51°. The new custom software was precise and quick in analyzing slit-lamp photographs to determine postoperative toric IOL rotation. Copyright 2014, SLACK Incorporated.

Selective and faithful imitation at 12 and 15 months.

Science.gov (United States)

Hilbrink, Elma E; Sakkalou, Elena; Ellis-Davies, Kate; Fowler, Nia C; Gattis, Merideth

2013-11-01

Research on imitation in infancy has primarily focused on what and when infants imitate. More recently, however, the question why infants imitate has received renewed attention, partly motivated by the finding that infants sometimes selectively imitate the actions of others and sometimes faithfully imitate, or overimitate, the actions of others. The present study evaluates the hypothesis that this varying imitative behavior is related to infants' social traits. To do so, we assessed faithful and selective imitation longitudinally at 12 and 15 months, and extraversion at 15 months. At both ages, selective imitation was dependent on the causal structure of the act. From 12 to 15 months, selective imitation decreased while faithful imitation increased. Furthermore, infants high in extraversion were more faithful imitators than infants low in extraversion. These results demonstrate that the onset of faithful imitation is earlier than previously thought, but later than the onset of selective imitation. The observed relation between extraversion and faithful imitation supports the hypothesis that faithful imitation is driven by the social motivations of the infant. We call this relation the King Louie Effect: like the orangutan King Louie in The Jungle Book, infants imitate faithfully due to a growing interest in the interpersonal nature of interactions. © 2013 John Wiley & Sons Ltd.

Final results of the prospective multicenter observational program RU-EGD-NI-001 for evaluation of efficacy and tolerability of the 6-month depot Eligard 45 mg in patients with advanced prostate carcinoma in routine clinical practice of uro-oncologists in the Russian Federation

Directory of Open Access Journals (Sweden)

V. B. Matveev

2017-01-01

Full Text Available Introduction. The 6-month depot formulation of leuproreline acetate 45 mg (Eligard, Astellas Pharma was shown to reduce the levels of prostate-specific antigen (PSA and testosterone and to be well tolerated in patients with advanced prostate cancer (PCa in clinical trials as well as other depot formulations of leuproreline acetate (1- and 3-month. However, clinical trials are limited by strict patient inclusion and exclusion criteria.Objective of this study, sponsored by Astellas Pharma Russia, was to assess whether the efficacy and tolerability of the 6-month leuprorelin depot formulation could be confirmed in a broad and heterogeneous patient population encountered in daily clinical practice in the Russian Federation.Materials and methods. A non-interventional multicenter study (a observational program was conducted in male patients with advanced PCa (T3–4, N+/M+, or with progression after local treatment to whom Eligard 45 mg had been prescribed. Patients were followed every 6 months up to 24 months of treatment. Fifty three uro-oncologists from out-patient clinics in the Russia participated in the study.Results. The study enrolled 640 patients, of which 524 met inclusion/exclusion criteria. Mean age of the patients was 69.0 ± 8.6 years old (from 46 to 96 years old. In most cases hormonal therapy with Eligard 45 mg was performed for locally advanced PCa (50 % of patients, distant metastases were detected in 15 % subjects only, nodal involvement was detected in 12 % patients. Patients with initially localized prostate cancer (41.4 % were prescribed Eligard 45 mg because of progression of their disease after local treatment or inability to receive any other treatment. Eligard 45 mg monotherapy was used in 92.75 % cases. Only 7.25 % patients received combined hormonal therapy with Eligard 45 mg and bicalutamide, flutamide and zoledronic acid. Mean serum PSA level was reduced by 81,7 % from 38,47 ng/ml at baseline to 7.05 ng/ml after 24 months

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...

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.

Nonsurgical treatment of peri-implantitis using an air-abrasive device or mechanical debridement and local application of chlorhexidine. Twelve-month follow-up of a prospective, randomized, controlled clinical study.

Science.gov (United States)

John, Gordon; Sahm, Narja; Becker, Jürgen; Schwarz, Frank

2015-11-01

The purpose of this prospective, parallel group-designed, randomized controlled clinical study was the evaluation of the effectiveness of an air-abrasive device (AAD) for nonsurgical treatment of peri-implantitis. Twenty five patients, showing at least one implant with initial to moderate peri-implantitis, underwent an oral hygiene programme and were randomly treated using either (1) AAD (amino acid glycine powder) or (2) mechanical debridement using carbon curettes and antiseptic therapy with chlorhexidine digluconate (mechanical debridement (MDA)). Clinical parameters were measured at baseline and 12 months after treatment (e.g. bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL)). At 12 months, the AAD group revealed significantly higher (p  0.05; Mann-Whitney test, respectively). Within its limitations, the present study has indicated that both treatment procedures resulted in comparable but limited CAL gains at 12 months. Furthermore, it could be detected that AAD was associated with significantly higher BOP decrease than MDA. The present results have indicated that nonsurgical therapy of peri-implantitis using both AAD and MDA resulted in comparable PD reductions and CAL gains after 12 months of healing. The BOP reductions were significantly higher in the AAD in comparison to the MDA group. So, AAD may be more effective for nonsurgical therapy of peri-implantitis than MDA.

Systolic Sac Pressure Index for the Prediction of Persistent Type II Endoleak for 12 Months After Endovascular Abdominal Aortic Aneurysm Repair

Energy Technology Data Exchange (ETDEWEB)

Ikoma, Akira, E-mail: yfb04322@nifty.com; Nakai, Motoki, E-mail: momonga@wakayama-med.ac.jp; Sato, Morio, E-mail: morisato@wakayama-med.ac.jp; Sato, Hirotatsu, E-mail: kuppa1220@yahoo.co.jp; Minamiguchi, Hiroki, E-mail: hiromina4@hotmail.com; Sonomura, Tetsuo, E-mail: sonomura@wakayama-med.ac.jp [Wakayama Medical University, Departments of Radiology (Japan); Nishimura, Yoshiharu, E-mail: nishim-y@wakayama-med.ac.jp; Okamura, Yoshitaka, E-mail: y-ok@wakayama-med.ac.jp [Wakayama Medical University, Thoracic and Cardiovascular Surgery (Japan)

2016-04-15

PurposeTo assess the relationship between the systolic sac pressure index (SPI) and the presence of endoleaks 12 months after endovascular abdominal aortic aneurysm repair (EVAR).Materials and MethodsWe performed a single-center prospective trial of consecutively treated patients. SPI (calculated as systolic sac pressure/systolic aortic pressure) was measured by catheterization immediately after EVAR. Contrast-enhanced computed tomography was scheduled 12 months after EVAR to detect possible endoleaks.ResultsData were available for 34 patients who underwent EVAR for an AAA. Persisting type II endoleak was found in 8 patients (endoleak-positive group) but not in the other 26 patients (endoleak-negative group). The mean ± standard deviation SPI was significantly greater in the endoleak-positive group than in the endoleak-negative group (0.692 ± 0.048 vs. 0.505 ± 0.081, respectively; P = .001). Receiver-operating characteristic curve analysis revealed that an SPI of 0.638 was the optimum cutoff value for predicting a persistent endoleak at 12 months with high accuracy (0.971; 33/34), sensitivity (1.00), and specificity (0.962) values. The mean change in AAA diameter was −4.28 ± 5.03 mm and 2.22 ± 4.54 mm in patients with SPI of <0.638 or ≥0.638, respectively (P = .002).ConclusionPatients with an SPI of ≥0.638 immediately after EVAR were more likely to have a persistent type II endoleak at 12 months with an accuracy of 0.971, and showed increases in aneurysm sac diameter compared with patients with an SPI of <0.638.

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.

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...

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.

Prospective SAH Study in Japan, 2005(Prospective SAH Study)

OpenAIRE

塩川, 芳昭; 栗田, 浩樹; 藤井, 清孝; Yoshiaki, SHIOKAWA; Hiroki, KURITA; Kiyotaka, FUJII; 杏林大学脳神経外科; 杏林大学脳神経外科; 北里大学脳神経外科; Department of Neurosurgery, Kyorin University School of Medicine; Department of Neurosurgery, Kyorin University School of Medicine

2009-01-01

To clarify current treatment status of ruptured cerebral aneurysms in Japan, a prospective multicenter observational study on the treatment results for aneurysmal subarachnoid hemorrhage was conducted over calendar year 2005 and final 1-year outcomes were collected. Studied centers were selected from among institutes of committee member of Japanese stroke surgery organization or symposium of vasospasm in Japan. A total of 927 patients were enrolled in this study and treatment policies were le...

A multi-center randomized controlled trial to compare a self-ligating bracket with a conventional bracket in a UK population: Part 1: Treatment efficiency.

Science.gov (United States)

O'Dywer, Lian; Littlewood, Simon J; Rahman, Shahla; Spencer, R James; Barber, Sophy K; Russell, Joanne S

2016-01-01

To use a two-arm parallel trial to compare treatment efficiency between a self-ligating and a conventional preadjusted edgewise appliance system. A prospective multi-center randomized controlled clinical trial was conducted in three hospital orthodontic departments. Subjects were randomly allocated to receive treatment with either a self-ligating (3M SmartClip) or conventional (3M Victory) preadjusted edgewise appliance bracket system using a computer-generated random sequence concealed in opaque envelopes, with stratification for operator and center. Two operators followed a standardized protocol regarding bracket bonding procedure and archwire sequence. Efficiency of each ligation system was assessed by comparing the duration of treatment (months), total number of appointments (scheduled and emergency visits), and number of bracket bond failures. One hundred thirty-eight subjects (mean age 14 years 11 months) were enrolled in the study, of which 135 subjects (97.8%) completed treatment. The mean treatment time and number of visits were 25.12 months and 19.97 visits in the SmartClip group and 25.80 months and 20.37 visits in the Victory group. The overall bond failure rate was 6.6% for the SmartClip and 7.2% for Victory, with a similar debond distribution between the two appliances. No significant differences were found between the bracket systems in any of the outcome measures. No serious harm was observed from either bracket system. There was no clinically significant difference in treatment efficiency between treatment with a self-ligating bracket system and a conventional ligation system.

The efficacy of an educational program for parents of children with epilepsy (FAMOSES): Results of a controlled multicenter evaluation study.

Science.gov (United States)

Hagemann, Anne; Pfäfflin, Margarete; Nussbeck, Fridtjof W; May, Theodor W

2016-11-01

The objective of this study was to evaluate the efficacy of the educational program FAMOSES (modular service package epilepsy for families) for parents of children with epilepsy. Parents of children with epilepsy from Germany and Austria were included in a controlled prospective multicenter study using a pre-post design. Participants of the FAMOSES program (FAMOSES group, n=148) completed a standardized questionnaire immediately before the program and six months later. The matched control group of parents not participating in the program (n=74, matching ratio 2:1) also answered the questionnaire twice, at an interval of six months. The questionnaire comprised epilepsy-specific outcome measures (e.g., knowledge, coping, fears) and disease-related variables (e.g., seizure frequency). The generalized estimation equation approach was used for statistical analysis. In addition, parents' satisfaction with the FAMOSES program was assessed six months after participation. Parents of the FAMOSES group significantly improved in epilepsy-specific knowledge (group×time interaction: pepilepsy-related fears (pepilepsy with their child (pepilepsy and reduce epilepsy-related fears. Copyright © 2016 Elsevier Inc. All rights reserved.

The effects of thoracic surgery operations on quality of life: a multicenter study.

Science.gov (United States)

Öz, Gürhan; Solak, Okan; Metin, Muzaffer; Esme, Hıdır; Sayar, Adnan

2015-10-01

Some treatment modalities may cause losses in patients' life comfort because of the treatment process. Our aim is to determine the effects of thoracic surgery operations on patients' quality of life. This is a multicenter and prospective study. A hundred patients, who had undergone posterolateral thoracotomy (PLT) and/or lateral thoracotomy (LT), were included in the study. A quality of life questionnaire (SF-36) was used to determine the changes in life comfort. SF-36 was performed before the operation, on the first month, third month, sixth month and twelfth month after the operation. Seventy-two percent (n = 72) of the patients were male. PLT was performed in 66% (n = 66) of the patients, and LT was performed in 34% (n = 34) of the patients. The types of resections in patients were pneumonectomy in four patients, lobectomy in 59 patients and wedge resection in 11 patients. No resection was performed in 26 patients. Thoracotomy caused deteriorations in physical function (PF), physical role (RP), bodily pain (BP), health, vitality and social function scores. The deteriorations observed in the third month improved in the sixth and twelfth months. The PF, RP, BP and MH scores of the patients with lung resection were much more worsened compared with the patients who did not undergo lung resection. Thoracic surgery operations caused substantial dissatisfaction in life comfort especially in the third month postoperatively. The worsening in physical function, physical role, pain and mental health is much more in patients with resection compared with the patients who did not undergo resection. © 2014 John Wiley & Sons Ltd.

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.

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.

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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.

[Pharmacotherapy of attention deficit hyperactivity disorder in children: the results of a multicenter double-blind placebo-controlled study of hopantenic acid].

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Zavadenko, N N; Suvorinova, N Yu; Vakula, I N; Malinina, E V; Kuzenkova, L M

To assess the efficacy and safety of hopantenic acid (pantogam) compared to placebo in the treatment of attention deficit hyperactivity disorder (ADHD) in children, aged from 6 to 12 years, during 4 month in the prospective multicenter comparative double-blind placebo-controlled study in parallel groups. One hundred patients enrolled in the safety assessment population were stratified into two equal pantogam and placebo groups. Eighty-nine patients who completed the study in according to the protocol were included in the efficacy assessment group: 45 in the pantogam group and 44 in the placebo group. Pantogam was administered in tablets (250 mg) in the therapeutic dose 30 mg/kg of body mass, divided into 2 doses, during 4 month. Patient's state was assessed by the total score on ADHD-DSM-IV, CGI-S WFIRS-P and results of the Toulouse-Piéron test for sustained attention. There was a trend towards an increase in the percentage of patients with positive changes (a decrease in the total ADHD-DSM-IV by ≥25%) in the end of the 3rd and 4th month in the pantogam group (treatment response was 66.7 and 68.9%, respectively) compared to the placebo group (treatment response was 52.3 and 61.4%, respectively). A significant decrease in disease severity assessed by the CGI-S was noted in the pantogam group compared to the placebo group. After 4 month of treatment with pantogam, the severity of functional disturbances was reduced by 4 out of 6 WFIRS-P domains: Family, School and learning, Child's self-concept and Risky activities. Pantogam improved the measures of sustained attention (accuracy and speed) in the Toulouse-Piéron test. The drug used in mean daily dose 30 mg/kg during 4 month had a favorable safety profile which did not differ from that of placebo.

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

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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.

Feasibility of a 12-month-exercise intervention during and after radiation and chemotherapy in cancer patients: impact on quality of life, peak oxygen consumption, and body composition

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Grabenbauer, Alexander; Grabenbauer, Andrea J.; Lengenfelder, Rosa; Grabenbauer, Gerhard G.; Distel, Luitpold V.

2016-01-01

Accumulating evidence suggests that exercise is effective in treating many of the acute and chronic side effects of anti-cancer therapy. A recent meta-analysis supported the use of exercise to prevent or treat fatigue and lymphoedema and to improve functional status in breast cancer patients. This trial was intended as a controlled, prospective feasibility study evaluating the impact of physical exercise (PE) in cancer patients during and after treatment with radio- and chemotherapy. Inclusion criteria were previous or ongoing treatment for cancer, motivation for PE of 0.5-1hour duration at least twice weekly for at least 3 months. Continuation of PE was encouraged thereafter. Every three months the following endpoints were assessed: Peak oxygen consumption as measured by supervised cardiopulmonary exercise test, body composition and quality of life. A total of 45 patients were included with a median age of 49 years. Forty were female and five male. Cancer types were: Breast cancer (n = 30/67 %), gastrointestinal cancer (n = 5/12 %), other types (n = 10/22 %). Thirty-eight (84 %) of the patients were included during curative treatment of their disease. Seven (16 %) were considered palliative. Adherence to the PE-programme longer than 6 months was noted for 41/45 (91 %) of the patients. Intensity of PE was thrice weekly in 32/45 (71 %), twice weekly in 11/45 (24 %). Two of 45 patients (5 %) had no PE. Mean peak oxygen consumption increased from 18.8 ± 5.6 ml/min/kg to 20.5 ± 3 ml/min/kg and 19.9 ± 4.7 ml/min/kg at 3 months (p = 0.005) and 12 months (p = 0.003), respectively. Median fat mass decreased from 30.7 ± 15 kg to 28.9 ± 15 kg and 29.5 ± 13 kg at 3 months (p = 0.001) and 12 months (p = 0.017), respectively. Global health status scores increased from a median baseline value of 54.9 ± 16.3 to 66.4 ± 14 % and 68.0 ± 20.3 % at 3 months (p = 0.001) and 12 months (p = 0.002), respectively. This exercise programme in cancer patients with 2–3 weekly

Maternal antenatal depression and infant disorganized attachment at 12 months.

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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.

Endovascular brachytherapy prevents restenosis after femoropopliteal angioplasty: results of the Vienna-3 randomised multicenter study

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Pokrajac, Boris; Poetter, Richard; Wolfram, Roswitha M.; Budinsky, Alexandra C.; Kirisits, Christian; Lileg, Brigitte; Mendel, Helmuth; Sabeti, Schila; Schmid, Rainer; Minar, Erich

2005-01-01

Background and purpose: The aim of the trial was to investigate the effect of Iridium-192 gamma endovascular brachytherapy on reduction of restenosis after femoropopliteal angioplasty. Patients and methods: Between Oct, 1998 and Jul, 2001 a total of 134 patients have been randomized after successful angioplasty to brachytherapy or sham irradiation in a prospective, randomized, multicenter, double blind controlled trial. Patients with de novo lesion of at least 5 cm or recurrent lesion of any length after prior angioplasty have been enrolled. Brachytherapy was performed with 7 F centering catheter. Mean lesion length was 9.1 cm (1.5-25 cm) and mean intervention length 13.6 cm (4-27.5 cm) in brachytherapy cohort. Results: In placebo cohort mean lesion length was 10.3 cm (2-25 cm) and mean intervention length 14.1 cm (2-29 cm). A dose of 18 Gy was prescribed 2 mm from the surface of centering balloons. Analyzed (based on angiography) on intention to treat basis the binary restenosis rate at 12 months was 41.7% (28/67) in brachytherapy cohort and 67.1% (45/67) in placebo cohort (χ 2 test, P 30% residual stenosis after angioplasty) have been 23.4% in the brachytherapy and 53.3% in the placebo group (P<0.05), respectively. The cumulative patency rates after 24 months on intention to treat analysis were 54% in the brachytherapy and 27% in the placebo group (P<0.005). Corresponding data for as treated analysis were 77% in the brachytherapy and 39% in the placebo group (P<0.001). Late thrombosis was not seen. Conclusions: Significant reduction of restenosis rate was obtained with endovascular gamma brachytherapy after femoropopliteal angioplasty

Adverse events following 12 and 18 month vaccinations: a population-based, self-controlled case series analysis.

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Kumanan Wilson

Full Text Available BACKGROUND: Live vaccines have distinct safety profiles, potentially causing systemic reactions one to 2 weeks after administration. In the province of Ontario, Canada, live MMR vaccine is currently recommended at age 12 months and 18 months. METHODS: Using the self-controlled case series design we examined 271,495 12 month vaccinations and 184,312 18 month vaccinations to examine the relative incidence of the composite endpoint of emergency room visits or hospital admissions in consecutive one day intervals following vaccination. These were compared to a control period 20 to 28 days later. In a post-hoc analysis we examined the reasons for emergency room visits and the average acuity score at presentation for children during the at-risk period following the 12 month vaccine. RESULTS: Four to 12 days post 12 month vaccination, children had a 1.33 (1.29-1.38 increased relative incidence of the combined endpoint compared to the control period, or at least one event during the risk interval for every 168 children vaccinated. Ten to 12 days post 18 month vaccination, the relative incidence was 1.25 (95%, 1.17-1.33 which represented at least one excess event for every 730 children vaccinated. The primary reason for increased events was statistically significant elevations in emergency room visits following all vaccinations. There were non-significant increases in hospital admissions. There were an additional 20 febrile seizures for every 100,000 vaccinated at 12 months. CONCLUSIONS: There are significantly elevated risks of primarily emergency room visits approximately one to two weeks following 12 and 18 month vaccination. Future studies should examine whether these events could be predicted or prevented.

Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.

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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

Long term natural history data in ambulant boys with Duchenne muscular dystrophy: 36-month changes.

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Marika Pane

Full Text Available The 6 minute walk test has been recently chosen as the primary outcome measure in international multicenter clinical trials in Duchenne muscular dystrophy ambulant patients. The aim of the study was to assess the spectrum of changes at 3 years in the individual measures, their correlation with steroid treatment, age and 6 minute walk test values at baseline. Ninety-six patients from 11 centers were assessed at baseline and 12, 24 and 36 months after baseline using the 6 minute walk test and the North Star Ambulatory Assessment. Three boys (3% lost the ability to perform the 6 minute walk test within 12 months, another 13 between 12 and 24 months (14% and 11 between 24 and 36 months (12%. The 6 minute walk test showed an average overall decline of -15.8 (SD 77.3 m at 12 months, of -58.9 (SD 125.7 m at 24 months and -104.22 (SD 146.2 m at 36 months. The changes were significantly different in the two baseline age groups and according to the baseline 6 minute walk test values (below and above 350 m (p<0.001. The changes were also significantly different according to steroid treatment (p = 0.01. Similar findings were found for the North Star Ambulatory Assessment. These are the first 36 month longitudinal data using the 6 minute walk test and North Star Ambulatory Assessment in Duchenne muscular dystrophy. Our findings will help not only to have a better idea of the progression of the disorder but also provide reference data that can be used to compare with the results of the long term extension studies that are becoming available.

Long term natural history data in ambulant boys with Duchenne muscular dystrophy: 36-month changes.

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Pane, Marika; Mazzone, Elena Stacy; Sivo, Serena; Sormani, Maria Pia; Messina, Sonia; D'Amico, Adele; Carlesi, Adelina; Vita, Gianluca; Fanelli, Lavinia; Berardinelli, Angela; Torrente, Yvan; Lanzillotta, Valentina; Viggiano, Emanuela; D Ambrosio, Paola; Cavallaro, Filippo; Frosini, Silvia; Barp, Andrea; Bonfiglio, Serena; Scalise, Roberta; De Sanctis, Roberto; Rolle, Enrica; Graziano, Alessandra; Magri, Francesca; Palermo, Concetta; Rossi, Francesca; Donati, Maria Alice; Sacchini, Michele; Arnoldi, Maria Teresa; Baranello, Giovanni; Mongini, Tiziana; Pini, Antonella; Battini, Roberta; Pegoraro, Elena; Previtali, Stefano; Bruno, Claudio; Politano, Luisa; Comi, Giacomo P; Bertini, Enrico; Mercuri, Eugenio

2014-01-01

The 6 minute walk test has been recently chosen as the primary outcome measure in international multicenter clinical trials in Duchenne muscular dystrophy ambulant patients. The aim of the study was to assess the spectrum of changes at 3 years in the individual measures, their correlation with steroid treatment, age and 6 minute walk test values at baseline. Ninety-six patients from 11 centers were assessed at baseline and 12, 24 and 36 months after baseline using the 6 minute walk test and the North Star Ambulatory Assessment. Three boys (3%) lost the ability to perform the 6 minute walk test within 12 months, another 13 between 12 and 24 months (14%) and 11 between 24 and 36 months (12%). The 6 minute walk test showed an average overall decline of -15.8 (SD 77.3) m at 12 months, of -58.9 (SD 125.7) m at 24 months and -104.22 (SD 146.2) m at 36 months. The changes were significantly different in the two baseline age groups and according to the baseline 6 minute walk test values (below and above 350 m) (p<0.001). The changes were also significantly different according to steroid treatment (p = 0.01). Similar findings were found for the North Star Ambulatory Assessment. These are the first 36 month longitudinal data using the 6 minute walk test and North Star Ambulatory Assessment in Duchenne muscular dystrophy. Our findings will help not only to have a better idea of the progression of the disorder but also provide reference data that can be used to compare with the results of the long term extension studies that are becoming available.

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.

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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.

Urinary leukotriene E4 at 12 months and influencing factors

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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.

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

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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

Frey's pancreaticojejunostomy in tropical pancreatitis: assessment of quality of life. A prospective study.

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Pothula Rajendra, Vamsi Krishna; Sivanpillay Mahadevan, Sivaraj; Parvathareddy, Sivacharan Reddy; Nara, Bharat Kumar; Gorlagunta Ramachandra, Mallikarjuna; Tripuraneni Venkata, Aditya Chowdary; Bathalapalli, Jagan Mohan Reddy; Gudi, Vara Prasada Rao; Sampath, Thirunavukkarasu

2014-12-01

Tropical pancreatitis is a form of chronic pancreatitis originally described in the tropics. Prospective studies in Western countries have shown improved quality of life (QOL) following surgery in alcoholic chronic pancreatitis. In studies on Frey's pancreaticojejunostomy for tropical pancreatitis, improvement in pain was considered the endpoint, and there is a paucity of data in the literature with regard to QOL with tropical pancreatitis following surgery. Our objective was to prospectively analyze the outcome of Frey's pancreaticojejunostomy in tropical pancreatitis and health-related QOL following surgery by administering the Short Form 36-item health survey (SF-36). A total of 25 patients underwent Frey's pancreaticojejunostomy between 2010 and 2012 and were included in the study; data were collected prospectively. The visual analog scale (VAS) for pain and the SF-36 form were used to record health-related QOL preoperatively, and at 3 and 12 months post-surgery, comparing the same with the general population. Patients with tropical pancreatitis experience poor QOL (26.71 ± 15.95) compared with the general population (84.54 ± 12.42). Post-operative QOL scores (78.54 ± 15.84) were better than the pre-operative scores (26.71 ± 15.95) at 12-month post-surgery follow-up. The VAS score for pain improved at 12 months post-surgery (1.58 ± 1.41 vs. 8.21 ± 1.64). Two of the three patients (12.5 %) who had diabetes were free from anti-diabetes medication at 12 months post-surgery. Steatorrhea was seen in five patients (20.8 %) before surgery and increased to eight (33.3 %) at 12 months post-surgery. Mean body weight increased from 45.75 kg pre-operatively to 49.25 kg at 12 months post-operatively. Frey's pancreaticojejunostomy effectively reduces pain in tropical pancreatitis, with significant improvement in health-related QOL, which is comparable with the general population in most aspects.

DADOS-Prospective: an open source application for Web-based prospective data collection

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Nguyen Lam

2006-11-01

Full Text Available Abstract Background Randomized, prospective trials involving multi-institutional collaboration have become a central part of clinical and translational research. However, data management and coordination of multi-center studies is a complex process that involves developing systems for data collection and quality control, tracking data queries and resolutions, as well as developing communication procedures. We describe DADOS-Prospective, an open-source Web-based application for collecting and managing prospective data on human subjects for clinical and translational trials. DADOS-Prospective not only permits users to create new clinical research forms (CRF and supports electronic signatures, but also offers the advantage of containing, in a single environment, raw research data in downloadable spreadsheet format, source documentation and regulatory files stored in PDF format, and audit trails. Results Feedback from formal and field usability tests was used to guide the design and development of DADOS-Prospective. To date, DADOS-Prospective has been implemented in five prospective clinical studies at our institution. Four of these studies are still in the CRF creation phase and one study has been entirely launched. Conclusion DADOS-Prospective has significant advantages over existing Web-based data collecting programs. At our institution, it has been demonstrated to be an efficient tool for prospective clinical studies.

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

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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).

Preperimetric Glaucoma Prospective Observational Study (PPGPS: Design, baseline characteristics, and therapeutic effect of tafluprost in preperimetric glaucoma eye.

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Naoko Aizawa

Full Text Available There is no consensus on the diagnosis or treatment policy for Preperimetric Glaucoma (PPG because the pathogenesis of PPG is not clear at this time. Preperimetric Glaucoma Prospective Observational Study (PPGPS is a first multicenter, prospective, observational study to clarify the pathogenesis of PPG. This article indicates study design, patient baseline characteristics, and analysis focused on optic nerve head (ONH blood flow in PPG, as well as the intraocular pressure (IOP -lowering effect and ONH blood flow-improving effects of Tafluprost.In this study, 122 eyes from 122 subjects (mean age: 53.1 ± 14.3 newly diagnosed as PPG were enrolled. The circumpapillary retinal nerve fiber layer thickness (cpRNFLT was evaluated with optical coherence tomography (OCT. The ONH blood flow was measured with laser speckle flowgraphy. The therapeutic effect of Tafluprost was evaluated at Month 0 (ONH blood flow-improving effect and Month 4 (IOP-lowering effect.The untreated IOP, cpRNFLT, and baseline Mean deviation (MD value was 16.4 ± 2.5 mmHg, 80.4 ± 8.2 μm, and -0.48 ± 1.29 dB, respectively. In the site-specific visual field evaluation using the sector map, there was no appreciable site-specific visual field defect in the eye with PPG. The inferior region of cpRNFLT in 4-quadrant OCT sector analysis and 6 o'clock region in 12-o'clock OCT sector analysis was the highest rate of abnormality in PPG eyes. Topical administration of Tafluprost significantly reduced IOP from 16.4 ± 2.5 mmHg at baseline to 14.5 ± 2.3 mmHg at Month 4 (P < 0.001, paired t-test. In the linear regression analysis, there was a significant relationship between the increase of ONH blood flow and baseline value.PPGPS is a first prospective study focusing on the pathology of PPG. This study is expected to elucidate the pathology of PPG, with evidence useful for determining a treatment strategy for PPG.

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

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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.

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).

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

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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

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

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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.

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...

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.

12-month follow-up study of drug treatment in pathological gamblers: a primary outcome study.

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Dannon, Pinhas N; Lowengrub, Katherine; Musin, Ernest; Gonopolsky, Yehudit; Kotler, Moshe

2007-12-01

Pathological gambling (PG) is a relatively common and highly disabling impulse control disorder. A range of psychotherapeutic agents including selective serotonin reuptake inhibitors, antiepileptic drugs, and opioid antagonists are shown to be effective in the short-term treatment of PG. The use of a wide range of pharmacological treatments for PG is consistent with the observation that PG shares features of obsessive-compulsive spectrum disorders, impulse control disorders, and addictive disorders. The aim of the study is to assess the rate of relapse in treatment-responder pathological gamblers after discontinuation of the active treatment. Our study sample was composed of 43 male pathological gamblers who had been full responders to 1 of 4 drug treatment regimens (fluvoxamine, topiramate, bupropion SR, or naltrexone) from several previous acute open-label (12-week) comparison studies. Full response was defined as the absence of gambling for a 1-month duration together with improvement on the Clinical Global Improvement scale. The 43 full responders were then followed prospectively for an additional 9 months, which included a 3-month open-label continuation phase and a 6-month medication-free follow-up phase. Follow-up visits were performed on a monthly basis throughout the duration of study. At every follow-up visit, a comprehensive psychiatric diagnostic evaluation was performed on all patients, and patients were assessed for symptoms of gambling using a self-report instrument and collateral family reports. The Clinical Global Impression Improvement scale was also administered at every follow-up visit. Raters were blind to the previous drug treatment. Most patients did not relapse during the 6-month medication-free follow-up phase. Three of 6 patients with fluvoxamine, 3 of 9 with topiramate, 7 of 18 with bupropion SR, and 4 of 10 with naltrexone relapsed. Relapse was strictly defined as gambling behavior at any time during the 6-month medication-free follow

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

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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

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

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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

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.

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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.

The Effectiveness of Silodosin for Nocturnal Polyuria in Elderly Men With Benign Prostatic Hyperplasia: A Multicenter Study

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Young Won Kim

2015-09-01

Full Text Available Purpose: To investigate improvement in nocturia and nocturnal polyuria in nocturnal polyuria patients after silodosin administration by using a 3-day frequency volume chart. Methods: This was a prospective multicenter study. We enrolled nocturnal polyuria patients (nocturnal polyuria index [NPi]>0.33, aged ≥60 years, diagnosed with the 3-day frequency volume charts of patients with benign prostatic hyperplasia taking α-blockers. Of the 54 patients, 30 (55.6% completed the study according to the study protocol (per-protocol group, and 24 dropped out (dropout group. Results: Of the 24 patients in the dropout group, 5 withdrew consent due to side effects or lack of efficacy, 7 were lost to follow-up at 4 weeks, 8 were lost to follow-up at 12 weeks, and 4 dropped out due to failure to complete 3-day frequency volume charts at 12 weeks. In the per-protocol group, there was significant improvement in the International Prostate Symptom Score (IPSS, especially question numbers 1, 3, 4, 5, 6, 7, and the quality of life question (P=0.001, P=0.007, P0.33. Considering the high dropout rate of our study due to no implementation of 3-day frequency volume charts, prospective and large-scale studies are needed to confirm our results.

Mild pituitary phenotype in 3- and 12-month-old Aip-deficient male mice.

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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.

Do patients in Dutch nursing homes have more pressure ulcers than patients in German nursing homes? A prospective multicenter cohort study.

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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

Assessment of ocular hypotensive effect and safety 12 months after changing from an unfixed combination to a latanoprost 0.005% + timolol maleate 0.5% fixed combination.

Science.gov (United States)

Inoue, Kenji; Okayama, Ryoko; Higa, Risako; Wakakura, Masato; Tomita, Goji

2012-01-01

Latanoprost 0.005% + timolol maleate 0.5% combined eyedrops were recently made available in Japan. We prospectively investigated the intraocular pressure (IOP)-lowering effect, visual preservation effect, and adverse reactions of a one-year administration of this fixed combination. The subjects included 162 eyes from 162 patients diagnosed with either primary open-angle glaucoma or ocular hypertension and using an unfixed combination of latanoprost 0.005% and timolol maleate 0.5%. The unfixed combination was discontinued and replaced with the latanoprost 0.005% + timolol maleate 0.5% fixed combination with no washout period. IOP was measured before (baseline) and 3, 6, 9, and 12 months after the change. The mean deviation value of Humphrey field analysis was compared. Adverse reactions were examined at every follow-up. No significant differences were found between mean IOP values obtained at baseline (mean ± standard deviation, 15.2 ± 3.3 mmHg) 3 months (15.1 ± 3.2 mmHg), 6 months (15.3 ± 3.1 mmHg), 9 months (15.3 ± 3.1 mmHg), and 12 months (15.1 ± 3.2 mmHg) after the change from the unfixed to the fixed combination of eyedrops (P = 0.212). In addition, no significant differences were observed between mean deviation values obtained at baseline (-9.11 ± 6.94 dB) and 12 months (-10.08 ± 7.24 dB) after the change (P = 0.114). Thirty-one patients discontinued the fixed combination within 12 months of replacement, due to an insufficient IOP decrease (20 patients, 12.3%) and adverse reactions (11 patients, 6.8%). Following replacement of two eyedrop medications (latanoprost 0.005% and timolol maleate 0.5%) by one fixed combination (latanoprost 0.005% + timolol maleate 0.5%), IOP and visual field were preserved. However, 20% of the patients discontinued the new treatment because of an insufficient IOP decrease and complaints of adverse reactions.

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.

Expanding the Use of Time-Based Metering: Multi-Center Traffic Management Advisor

Science.gov (United States)

Landry, Steven J.; Farley, Todd; Hoang, Ty

2005-01-01

Time-based metering is an efficient air traffic management alternative to the more common practice of distance-based metering (or "miles-in-trail spacing"). Despite having demonstrated significant operational benefit to airspace users and service providers, time-based metering is used in the United States for arrivals to just nine airports and is not used at all for non-arrival traffic flows. The Multi-Center Traffic Management Advisor promises to bring time-based metering into the mainstream of air traffic management techniques. Not constrained to operate solely on arrival traffic, Multi-Center Traffic Management Advisor is flexible enough to work in highly congested or heavily partitioned airspace for any and all traffic flows in a region. This broader and more general application of time-based metering is expected to bring the operational benefits of time-based metering to a much wider pool of beneficiaries than is possible with existing technology. It also promises to facilitate more collaborative traffic management on a regional basis. This paper focuses on the operational concept of the Multi-Center Traffic Management Advisor, touching also on its system architecture, field test results, and prospects for near-term deployment to the United States National Airspace System.

12 CFR Appendix I to Part 27 - Monthly Home Loan Activity Format

Science.gov (United States)

2010-01-01

... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Monthly Home Loan Activity Format I Appendix I to Part 27 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY FAIR HOUSING HOME LOAN DATA SYSTEM Pt. 27, App. I Appendix I to Part 27—Monthly Home Loan Activity Format EC22SE91...

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.

Recovery, relapse, or else? Treatment outcomes in gambling disorder from a multicenter follow-up study.

Science.gov (United States)

Müller, K W; Wölfling, K; Dickenhorst, U; Beutel, M E; Medenwaldt, J; Koch, A

2017-06-01

Gambling disorder is associated with various adverse effects. While data on the immediate effectiveness of treatment programs are available, follow-up studies examining long-term effects are scarce and factors contributing to a stable therapy outcome versus relapse are under-researched. Patients (n=270) finishing inpatient treatment for gambling disorder regularly participated in a prospective multicenter follow-up study (pre-treatment, post-treatment, 12-month follow-up). Criteria for gambling disorder, psychopathology, functional impairment were defined as endpoints. Changes in personality were defined as an additional parameter. At follow-up, three groups were identified: subjects maintaining full abstinence (41.6%), patients still meeting criteria for gambling disorder (29.2%), and subjects still participating in gambling without meeting the diagnostic criteria for gambling disorder (29.2%). Every group had improvements in functional impairment, abstinent subjects showed the lowest psychopathology. Significant decreases in neuroticism and increases in both extraversion and conscientiousness were found among abstinent subjects but not in patients still meeting criteria for gambling disorder. One year after treatment, a considerable percentage of patients kept on gambling but not all of them were classified with gambling disorder leading to the question if abstinence is a necessary goal for every patient. The changes of personality in abstinent patients indicate that after surmounting gambling disorder a subsequent maturing of personality might be a protective factor against relapse. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

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.

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.

[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.

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

A multicenter, randomized, double-blind, placebo-controlled, 6-month trial of bupropion hydrochloride sustained-release tablets as an aid to smoking cessation in hospital employees

DEFF Research Database (Denmark)

Dalsgareth, O.J.; Gerner Hansen, Niels-Christian; Soes-Petersen, U.

2004-01-01

(Zyban) compared with placebo as an aid to smoking cessation in health care workers. A total of 336 hospital employees who smoked at least 10 cigarettes daily were randomized (2:1) to 7 weeks of treatment with bupropion (n=222) or placebo (n=114). All participants were motivated to quit smoking......Despite changes in smoking behavior, one-third of the Danish population continues to smoke. Many of these smokers are hospital employees. This 6-month, multicenter, parallel group, randomized, double-blind, placebo-controlled study evaluated treatment with bupropion hydrochloride sustained release...... more frequently in the bupropion group than in the placebo group. Bupropion was effective as an aid to smoking cessation in a broad group of hospital employees in Denmark....

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

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.

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.

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.

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.

Parotid gland-recovery after radiotherapy in the head and neck region - 36 months follow-up of a prospective clinical study

Science.gov (United States)

2011-01-01

Background The aim of the present study was to evaluate the recovery potential of the parotid glands after using either 3D-conformal-radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) by sparing one single parotid gland. Methods Between 06/2002 and 10/2008, 117 patients with head and neck cancer were included in this prospective, non-randomised clinical study. All patients were treated with curative intent. Salivary gland function was assessed by measuring stimulated salivary flow at the beginning, during and at the end of radiotherapy as well as 1, 6, 12, 24, and 36 months after treatment. Measurements were converted to flow rates and normalized relative to rates before treatment. Mean doses (Dmean) were calculated from dose-volume histograms based on computed tomographies of the parotid glands. Results Patients were grouped according to the Dmean of the spared parotid gland having the lowest radiation exposure: Group I - Dmean 40 Gy (n = 36). 15/117 (13%) patients received IMRT. By using IMRT as compared to 3D-CRT the Dmean of the spared parotid gland could be significantly reduced (Dmean IMRT vs. 3D-CRT: 21.7 vs. 34.4 Gy, p < 0.001). The relative salivary flow rates (RFSR) as a function of the mean parotid dose after 24 and 36 months was in group I 66% and 74%, in group II 56% and 49%, and in group III 31% and 24%, respectively. Multiple linear regression analyses revealed that the parotid gland dose and the tumor site were the independent determinants 12 and 36 months after the end of RT. Patients of group I and II parotid gland function did recover at 12, 24, and 36 months after the end of RT. Conclusions If a Dmean < 26 Gy for at least one parotid gland can be achieved then this is sufficient to reach complete recovery of pre-RT salivary flow rates. The radiation volume which depends on tumor site did significantly impact on the Dmean of the parotids, and thus on the saliva flow and recovery of parotid gland. PMID:21951317

Parotid gland-recovery after radiotherapy in the head and neck region - 36 months follow-up of a prospective clinical study

International Nuclear Information System (INIS)

Hey, Jeremias; Setz, Juergen; Gerlach, Reinhard; Janich, Martin; Hildebrandt, Guido; Vordermark, Dirk; Gernhardt, Christian R; Kuhnt, Thomas

2011-01-01

The aim of the present study was to evaluate the recovery potential of the parotid glands after using either 3D-conformal-radiotherapy (3D-CRT) or intensity-modulated radiotherapy (IMRT) by sparing one single parotid gland. Between 06/2002 and 10/2008, 117 patients with head and neck cancer were included in this prospective, non-randomised clinical study. All patients were treated with curative intent. Salivary gland function was assessed by measuring stimulated salivary flow at the beginning, during and at the end of radiotherapy as well as 1, 6, 12, 24, and 36 months after treatment. Measurements were converted to flow rates and normalized relative to rates before treatment. Mean doses (D mean ) were calculated from dose-volume histograms based on computed tomographies of the parotid glands. Patients were grouped according to the D mean of the spared parotid gland having the lowest radiation exposure: Group I - D mean < 26 Gy (n = 36), group II - D mean 26-40 Gy (n = 45), and group III - D mean > 40 Gy (n = 36). 15/117 (13%) patients received IMRT. By using IMRT as compared to 3D-CRT the D mean of the spared parotid gland could be significantly reduced (D mean IMRT vs. 3D-CRT: 21.7 vs. 34.4 Gy, p < 0.001). The relative salivary flow rates (RFSR) as a function of the mean parotid dose after 24 and 36 months was in group I 66% and 74%, in group II 56% and 49%, and in group III 31% and 24%, respectively. Multiple linear regression analyses revealed that the parotid gland dose and the tumor site were the independent determinants 12 and 36 months after the end of RT. Patients of group I and II parotid gland function did recover at 12, 24, and 36 months after the end of RT. If a D mean < 26 Gy for at least one parotid gland can be achieved then this is sufficient to reach complete recovery of pre-RT salivary flow rates. The radiation volume which depends on tumor site did significantly impact on the D mean of the parotids, and thus on the saliva flow and recovery of

Adverse Events following 12 and 18 Month Vaccinations: a Population-Based, Self-Controlled Case Series Analysis

OpenAIRE

Wilson, Kumanan; Hawken, Steven; Kwong, Jeffrey C.; Deeks, Shelley; Crowcroft, Natasha S.; Van Walraven, Carl; Potter, Beth K.; Chakraborty, Pranesh; Keelan, Jennifer; Pluscauskas, Michael; Manuel, Doug

2011-01-01

BACKGROUND: Live vaccines have distinct safety profiles, potentially causing systemic reactions one to 2 weeks after administration. In the province of Ontario, Canada, live MMR vaccine is currently recommended at age 12 months and 18 months. METHODS: Using the self-controlled case series design we examined 271,495 12 month vaccinations and 184,312 18 month vaccinations to examine the relative incidence of the composite endpoint of emergency room visits or hospital admissions in consecutive o...

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 ...

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

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.

Descriptive epidemiology of the Multicenter ACL Revision Study (MARS) cohort.

Science.gov (United States)

Wright, Rick W; Huston, Laura J; Spindler, Kurt P; Dunn, Warren R; Haas, Amanda K; Allen, Christina R; Cooper, Daniel E; DeBerardino, Thomas M; Lantz, Brett Brick A; Mann, Barton J; Stuart, Michael J

2010-10-01

Revision anterior cruciate ligament (ACL) reconstruction has worse outcomes than primary reconstructions. Predictors for these worse outcomes are not known. The Multicenter ACL Revision Study (MARS) Group was developed to perform a multisurgeon, multicenter prospective longitudinal study to obtain sufficient subjects to allow multivariable analysis to determine predictors of clinical outcome. To describe the formation of MARS and provide descriptive analysis of patient demographics and clinical features for the initial 460 enrolled patients to date in this prospective cohort. Cross-sectional study; Level of evidence, 2. After training and institutional review board approval, surgeons began enrolling patients undergoing revision ACL reconstruction, recording patient demographics, previous ACL reconstruction methods, intra-articular injuries, and current revision techniques. Enrolled subjects completed a questionnaire consisting of validated patient-based outcome measures. As of April 1, 2009, 87 surgeons have enrolled a total of 460 patients (57% men; median age, 26 years). For 89%, the reconstruction was the first revision. Mode of failure as deemed by the revising surgeon was traumatic (32%), technical (24%), biologic (7%), combination (37%), infection (MARS Group has been able to quickly accumulate the largest revision ACL reconstruction cohort reported to date. Traumatic reinjury is deemed by surgeons to be the most common single mode of failure, but a combination of factors represents the most common mode of failure. Allograft graft choice is more common in the revision setting than autograft. Concomitant knee injury is extremely common in this population.

A long-term randomised trial on tenoxicam and piroxicam in osteoarthritis of the hip or knee: a 24-month interim report focusing on the 12-24 month interval

DEFF Research Database (Denmark)

Lund, B; Andersen, R B; Fossgreen, J

1987-01-01

The long-acting antiphlogistics tenoxicam (Ro 12-0068, Tilcotil) and piroxicam in single daily oral doses of 20 mg are compared in a double-blind, group-comparative, randomised trial planned to last for five years. Results of 12 months' treatment of 108 patients with osteoarthritis of the hip...... or knee have been reported. This interim analysis focuses mainly on the 12 to 24 month interval. The clinical improvements obtained within the first 12 months persisted during the second year in the 55 patients remaining on treatment. After 24 months, 53 patients had been withdrawn prematurely, three......-quarters because of inefficacy or intolerance. Only six patients were withdrawn between 12 and 24 months, three for lack of efficacy, two for side-effects and one for reasons unrelated to therapy. There was no difference between the treatment groups with regard to incidence, time or reason for withdrawal, and only...

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

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.

Multicenter results of stereotactic body radiotherapy (SBRT) for non-resectable primary liver tumors

Energy Technology Data Exchange (ETDEWEB)

Ibarra, Rafael A.; Rojas, Daniel; Sanabria, Juan R. [Dept. of Surgery, Univ. Hospitals-Case Medical Center, Cleveland, OH (United States)], email: juan.sanabria@uhhospitals.org [and others

2012-05-15

Background. An excess of 100 000 individuals are diagnosed with primary liver tumors every year in USA but less than 20% of those patients are amenable to definitive surgical management due to advanced local disease or comorbidities. Local therapies to arrest tumor growth have limited response and have shown no improvement on patient survival. Stereotactic body radiotherapy (SBRT) has emerged as an alternative local ablative therapy. The purpose of this study was to evaluate the tumor response to SBRT in a combined multicenter database. Study design. Patients with advanced hepatocellular carcinoma (HCC, n = 21) or intrahepatic cholangiocarcinoma (ICC, n = 11) treated with SBRT from four Academic Medical Centers were entered into a common database. Statistical analyses were performed for freedom from local progression (FFLP) and patient survival. Results. The overall FFLP for advanced HCC was 63% at a median follow-up of 12.9 months. Median tumor volume decreased from 334.2 to 135 cm{sup 3} (p < 0.004). The median time to local progression was 6.3 months. The 1- and 2-years overall survival rates were 87% and 55%, respectively. Patients with ICC had an overall FFLP of 55.5% at a median follow-up of 7.8 months. The median time to local progression was 4.2 months and the six-month and one-year overall survival rates were 75% and 45%, respectively. The incidence of grade 1-2 toxicities, mostly nausea and fatigue, was 39.5%. Grade 3 and 4 toxicities were present in two and one patients, respectively. Conclusion. Higher rates of FFLP were achieved by SBRT in the treatment of primary liver malignancies with low toxicity.

REDUCING SUICIDAL IDEATION AND DEPRESSION IN OLDER PRIMARY CARE PATIENTS: 24-MONTH OUTCOMES OF THE PROSPECT STUDY

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Alexopoulos, George S.; Reynolds, Charles F.; Bruce, Martha L.; Katz, Ira R.; Raue, Patrick J.; Mulsant, Benoit H.; Oslin, David; Have, Thomas Ten

2010-01-01

Objective The PROSPECT Study evaluated the impact of a care management intervention on suicidal ideation and depression in older primary care patients. This is the first report of outcomes over a 2-year period. Method The subjects (N=599) were older (>=60 years) patients with major or minor depression selected after screening 9,072 randomly identified patients of 20 primary care practices randomly assigned to the PROSPECT intervention or usual care. The intervention consisted of services of 15 trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 24 months. Results Intervention patients had a higher likelihood to receive antidepressants and or psychotherapy (84.9–89% vs. 49–59%) and a 2.2 times greater decline in suicidal ideation than usual care patients over 24 months. Treatment response occurred earlier in intervention patients and continued to increase from the 18th to the 24th month, while there was no appreciable increase in usual care patients during the same period. Among patients with major depression, a greater number achieved remission in the intervention than the usual care group at 4 (26.6 vs. 15.2%), 8 (36% vs. 22.5%), and 24 (45.4% vs. 31.5%) months. Patients with minor depression had favorable outcomes regardless of treatment assignment. Conclusions Sustained collaborative care maintains high utilization of antidepressant treatment, reduces suicidal ideation, and improves the outcomes of major depression over two years. These observations suggest that sustained collaborative care increases depression-free days. PMID:19528195

FTY720 and everolimus in de novo renal transplant patients at risk for delayed graft function: results of an exploratory one-yr multicenter study.

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Tedesco-Silva, H; Lorber, M I; Foster, C E; Sollinger, H W; Mendez, R; Carvalho, D B; Shapiro, R; Rajagopalan, P R; Mayer, H; Slade, J; Kahan, B D

2009-01-01

This exploratory, multicenter, open-label study evaluated the efficacy and safety of FTY720, as a part of an immunosuppressive regimen, in combination with everolimus and steroids in de novo renal transplant recipients at increased risk of delayed graft function (DGF). Patients received FTY720 (5 mg) and everolimus (4 mg) 2-12 h pre-transplantation, followed by 2.5 mg/d FTY720 and concentration-controlled everolimus (4-8 ng/mL) post-transplant for 12 months. Induction therapy was prohibited. After enrollment of 56 of the planned 200 patients between 2000 and 2002, the recruitment was terminated. The primary endpoint, rate of graft loss, or death at three months was 15.4% and the biopsy-confirmed acute rejection was 42.3%. Death or graft loss at 12 months in the DGF and non-DGF arms was 36.0% and 25.9%, respectively. The mean estimated creatinine clearance at three months was 63 and 55 mL/min in the non-DGF and DGF groups, respectively, while at 12 months it was 56 mL/min in both the groups. Although there was no comparator arm, the results from this exploratory study (compared with data from other phases II and III trials) indicated no apparent benefits of FTY720-based regimens for prevention of acute rejection and preservation of renal function in renal transplant recipients at high risk of DGF.

Histological analysis and identification of spermatogenesis-related genes in 2-, 6-, and 12-month-old sheep testes

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Bai, Man; Sun, Limin; Zhao, Jia; Xiang, Lujie; Cheng, Xiaoyin; Li, Jiarong; Jia, Chao; Jiang, Huaizhi

2017-10-01

Testis development and spermatogenesis are vital factors that influence male animal fertility. In order to identify spermatogenesis-related genes and further provide a theory basis for finding biomarkers related to male sheep fertility, 2-, 6-, and 12-month-old Small Tail Han Sheep testes were selected to investigate the dynamic changes of sheep testis development. Hematoxylin-eosin routine staining and RNA-Seq technique were used to perform histological and transcriptome analysis for these testes. The results showed that 630, 102, and 322 differentially expressed genes (DEGs) were identified in 2- vs 6-month-old, 6- vs 12-month-old, and 2- vs 12-month-old testes, respectively. GO and KEGG analysis showed the following: DEGs in 2- vs 6-month-old testes were mainly related to the GO terms of sexual maturation and the pathways of multiple metabolism and biosynthesis; in 6- vs 12-month-old testes, most of the GO terms that DEGs involved in were related to metabolism and translation processes; the most significantly enriched pathway is the ribosome pathway. The union of DEGs in 2- vs 6-month-old, 6- vs 12-month-old, and 2- vs 12-month-old testes was categorized into eight profiles by series cluster. Subsequently, the eight profiles were classified into four model profiles and four co-expression networks were constructed based on the DEGs in these model profiles. Finally, 29 key regulatory genes related to spermatogenesis were identified in the four co-expression networks. The expression of 13 DEGs (CA3, APOH, MYOC, CATSPER4, SYT6, SERPINA10, DAZL, ADIPOR2, RAB13, CEP41, SPAG4, ODF1, and FRG1) was validated by RT-PCR.

Efficacy of levofloxacin in the treatment of BK viremia: a multicenter, double-blinded, randomized, placebo-controlled trial.

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Lee, Belinda T; Gabardi, Steven; Grafals, Monica; Hofmann, R Michael; Akalin, Enver; Aljanabi, Aws; Mandelbrot, Didier A; Adey, Deborah B; Heher, Eliot; Fan, Pang-Yen; Conte, Sarah; Dyer-Ward, Christine; Chandraker, Anil

2014-03-01

BK virus reactivation in kidney transplant recipients can lead to progressive allograft injury. Reduction of immunosuppression remains the cornerstone of treatment for active BK infection. Fluoroquinolone antibiotics are known to have in vitro antiviral properties, but the evidence for their use in patients with BK viremia is inconclusive. The objective of the study was to determine the efficacy of levofloxacin in the treatment of BK viremia. Enrollment in this prospective, multicenter, double-blinded, placebo-controlled trial occurred from July 2009 to March 2012. Thirty-nine kidney transplant recipients with BK viremia were randomly assigned to receive levofloxacin, 500 mg daily, or placebo for 30 days. Immunosuppression in all patients was adjusted on the basis of standard clinical practices at each institution. Plasma BK viral load and serum creatinine were measured monthly for 3 months and at 6 months. At the 3-month follow-up, the percentage reductions in BK viral load were 70.3% and 69.1% in the levofloxacin group and the placebo group, respectively (P=0.93). The percentage reductions in BK viral load were also equivalent at 1 month (58% versus and 67.1%; P=0.47) and 6 months (82.1% versus 90.5%; P=0.38). Linear regression analysis of serum creatinine versus time showed no difference in allograft function between the two study groups during the follow-up period. A 30-day course of levofloxacin does not significantly improve BK viral load reduction or allograft function when used in addition to overall reduction of immunosuppression.

Corporal and testicular biometry in wild boar from birth to 12 months of age

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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.

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

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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.

Volumetric analysis demonstrates that true and false lumen remodeling persists for 12 months after thoracic endovascular aortic repair

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Ga-Young Suh, PhD

2016-09-01

Full Text Available A 62-year-old man underwent an elephant trunk procedure followed by thoracic endovascular aortic repair (TEVAR. Computed tomography angiography-based models were built to quantify volume of the whole aorta and true and false lumens preoperatively, before TEVAR, after TEVAR, and at follow-up at 3, 6, and 12 months. With TEVAR, descending aortic true lumen volume increased by 54%, then increased additionally by 60% during 12 months. The descending aortic false lumen volume regressed continuously for 12 months following TEVAR, with the most rapid rate from 6 to 12 months at 16 cm3/month. TEVAR immediately increased true lumen volume and continued to remodel the true and false lumens throughout the following 12 months.

Moderate risk-adapted dose escalation with 3D-conformal radiotherapy for prostate cancer from 70 to 74 Gy : long-term morbidity and survival from a prospective phase II trial

International Nuclear Information System (INIS)

Bombosch, V. B.

2015-01-01

Abstract English Background and Purpose: Evaluation of late side-effects and survival more than 60 months after 3-dimensional conformal radiotherapy with moderate, risk adapted dose escalation from 70 to 74 Gy in patients with localized prostate cancer within a prospective Austrian-German phase II multicenter trial. Material and Methods: Between 03/1999 and 07/2002 486 patients were registered in the prospective Austrian-German multicenter phase II trial. 441 (90.7%) patients were evaluated. Patients in the low and intermediate risk group were treated with 70Gy, patients in the high risk group received 74Gy. Additional hormonal-therapy was recommended for intermediate- and high-risk group patients. Gastrointestinal (GI) and genitourinary (GU) late toxicity according to EORTC/RTOG criteria, initial appearance, prevalence and duration of grade >=2 side-effects were investigated. Furthermore bNED (Phoenix/Nadir + 2), overall and disease specific survival were prospectively assessed. Results: Median follow-up was 90 (2-158) months in all 441 patients and 99 (18-158) months in living patients. 154 patients (35%) had a follow-up of longer or equal 120 months. Distribution among risk groups was 26% (low), 51% (intermediate) and 23% (high). HT was administered in 86% of patients prior to RT. Late gastrointestinal side-effects at 5- and 10 years were 29%/32% (70/74Gy) and 30%/35% (70/74Gy) as actuarial rates; p=0.67. Late genitourinary side-effects at 5- and 10 years were 17%/26% (70/74Gy) and 27%/34% (70/74Gy); p=0.12. No more than 15% (GI) and 15% (GU) of patients suffered from side-effects >=2 at any time after the end of therapy (prevalence). The proportion of patients suffering from severe toxicity was low (Grade 3 GI: 2%, GU: 10%). 10 year actuarial bNED rate was 65%, 70% and 58% in the low-, intermediate- and high risk group according to Phoenix (Nadir +2) criteria. Overall and disease specific survival were 67% and 91% in all patients. Conclusion: Dose escalation

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

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

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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.

Home noninvasive positive pressure ventilation with built-in software in stable hypercapnic COPD: a short-term prospective, multicenter, randomized, controlled trial.

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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

Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study.

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Lee, Seung-Ah; Suh, Jung-Won; Park, Jin Joo; Yoon, Chang-Hwan; Cho, Young-Suk; Youn, Tae-Jin; Chae, In-Ho; Kim, Hyo-Soo; Kim, Sang-Hyun; Choi, Dong-Ju

2015-07-01

The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643). Copyright © 2015. Published by Elsevier Inc.

The Effectiveness of Silodosin for Nocturnal Polyuria in Elderly Men With Benign Prostatic Hyperplasia: A Multicenter Study.

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Kim, Young Won; Park, Jinsung; Chung, Hong; Kim, Hong-Wook; Kim, Hyung Joon; Jung, Jae Hung; Kim, Won Tae

2015-09-01

To investigate improvement in nocturia and nocturnal polyuria in nocturnal polyuria patients after silodosin administration by using a 3-day frequency volume chart. This was a prospective multicenter study. We enrolled nocturnal polyuria patients (nocturnal polyuria index [NPi]>0.33), aged ≥60 years, diagnosed with the 3-day frequency volume charts of patients with benign prostatic hyperplasia taking α-blockers. Of the 54 patients, 30 (55.6%) completed the study according to the study protocol (per-protocol group), and 24 dropped out (dropout group). Of the 24 patients in the dropout group, 5 withdrew consent due to side effects or lack of efficacy, 7 were lost to follow-up at 4 weeks, 8 were lost to follow-up at 12 weeks, and 4 dropped out due to failure to complete 3-day frequency volume charts at 12 weeks. In the per-protocol group, there was significant improvement in the International Prostate Symptom Score (IPSS), especially question numbers 1, 3, 4, 5, 6, 7, and the quality of life question (P=0.001, P=0.007, Psilodosin monotherapy exhibits good efficacy in improving nocturia and nocturnal polyuria; however, the mean NPi was still >0.33. Considering the high dropout rate of our study due to no implementation of 3-day frequency volume charts, prospective and large-scale studies are needed to confirm our results.

Understanding the Abstract Role of Speech in Communication at 12 Months

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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…

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

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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.

Differences in How 12- and 24-Month-Olds Interpret the Gaze of Adults

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Moore, Chris; Povinelli, Daniel J.

2007-01-01

This study examined the hypothesis that toddlers interpret an adult's head turn as evidence that the adult was looking at something, whereas younger infants interpret gaze based on an expectancy that an interesting object will be present on the side to which the adult has turned. Infants of 12 months and toddlers of 24 months were first shown that…

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.

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

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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.

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

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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

Long-term (12-month) improvement in meibomian gland function and reduced dry eye symptoms with a single thermal pulsation treatment.

Science.gov (United States)

Greiner, Jack V

2013-08-01

To determine the 1-year post-treatment dry eye status of subjects with meibomian gland dysfunction and dry eye symptoms after receiving a single LipiFlow Thermal Pulsation System treatment. Single-centre, prospective, observational, open-label, 1-month-registered clinical trial with a 1-year follow-up examination. Patients with evaporative dry eye disease with meibomian gland dysfunction and dry eye symptoms who had participated in the registered 1-month clinical trial. Eighteen of 30 subjects initially enrolled were able to return for a 1-year follow-up. Both eyes of all patients were treated with a single 12-min treatment using the LipiFlow Thermal Pulsation System. Meibomian gland function, tear break-up time and dry eye symptoms were measured. Data are presented for pretreatment (baseline), and 1-month and 1-year post-treatment. Meibomian gland secretion scores, and tear break-up time and dry eye symptoms. Significant improvement in meibomian gland secretion scores from baseline measurements (4.0 ± 3.4) to 1-month post-treatment (11.3 ± 4.7; P treatment (6.0 ± 4.4). The significant improvement in symptom scores on Ocular Surface Disease Index and Standard Patient Evaluation of Eye Dryness questionnaires observed at 1-month (P Eye Dryness [P treatment with the Lipi Flow Thermal Pulsation System offers an effective treatment for evaporative dry eye and meibomian gland dysfunction resulting in significant and sustained improvement in signs and symptoms for up to 1 year. © 2012 The Author. Clinical and Experimental Ophthalmology © 2012 Royal Australian and New Zealand College of Ophthalmologists.

Sexual function and postpartum depression 6 months after attempted operative vaginal delivery according to fetal head station: A prospective population-based cohort study.

Directory of Open Access Journals (Sweden)

Guillaume Ducarme

Full Text Available To evaluate the effect of the fetal head station at attempted operative vaginal delivery (aOVD, and specifically midpelvic or low aOVD, on female and male sexual function and symptoms of postpartum depression (PPD at 6 months.Prospective population-based cohort study.1,941 women with singleton term fetuses in vertex presentation with midpelvic or low aOVD between 2008 and 2013 in a tertiary care university hospital.Symptoms of female sexual dysfunction using the Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Short Form Questionnaire (PISQ-12, symptoms of PPD using the Edinburgh Postnatal Depression Scale (EPDS score, symptoms of male sexual dysfunction using the International Index of Erectile Function (IIEF-15 and perineal pain were assessed 6 months after aOVD. We measured the association between midpelvic or low aOVD and symptoms of female and male sexual function and symptoms of PPD at 6 months using multiple regression and adjusting for demographics, and risk factors of sexual dysfunction, symptoms of PPD and perineal pain with adjusted odds ratios (aORs and 95% confidence intervals (95% CI.The study included 907 women (46.7% who responded to the questionnaire; 18.4% (167/907 had midpelvic aOVD, and 81.6% (740/907 low. Most women (873/907 [96.3%] of those with partners reported sexual activity at 6 months. No significant difference was observed for PISQ-12, EPDS, IIEF-15 scores and perineal pain between mid and low pelvic groups. Compared with low pelvic aOVD, midpelvic aOVD was not significantly associated with either female or male sexual dysfunction (p = 0.89 and p = 0.76, respectively, or maternal symptoms of PPD (p = 0.83. Perineal pain significantly increased the risk of male and female sexual dysfunction and maternal symptoms of PPD at 6 months (p = 0.02, p = 0.006, and p = 0.02, respectively.Midpelvic compared with low pelvic aOVD was not associated with an increase in sexual dysfunction, nor with symptoms of PPD at 6

Urinary calprotectin and posttransplant renal allograft injury

DEFF Research Database (Denmark)

Tepel, Martin; Borst, Christoffer; Bistrup, Claus

2014-01-01

OBJECTIVE: Current methods do not predict the acute renal allograft injury immediately after kidney transplantation. We evaluated the diagnostic performance of urinary calprotectin for predicting immediate posttransplant allograft injury. METHODS: In a multicenter, prospective-cohort study of 144...... incipient renal transplant recipients, we postoperatively measured urinary calprotectin using an enzyme-linked immunosorbent assay and estimated glomerular filtration rate (eGFR) after 4 weeks, 6 months, and 12 months. RESULTS: We observed a significant inverse association of urinary calprotectin...... concentrations and eGFR 4 weeks after transplantation (Spearman r = -0.33; Prelative risk, 4.3; P

FEMIC (Fibromes Embolises aux MICrospheres calibrees): Uterine Fibroid Embolization using Tris-acryl Microspheres. A French Multicenter Study

International Nuclear Information System (INIS)

Joffre, Francis; Tubiana, Jean-Michel; Pelage, Jean-Pierre

2004-01-01

Purpose: A French multicenter registry was set up to confirm the safety and efficacy of large calibrated tris-acryl gelatin microspheres for embolization of symptomatic fibroids. Methods: Technical recommendations included embolization using large microspheres (>500 μm) with no secondary embolization agent. Postprocedural pain, clinical improvement and adverse events were prospectively evaluated during a follow-up period of at least 6 months.Results: Eighty-five women complaining of fibroid-related symptoms entered the study. In seven women, a secondary embolization agent was used in addition to microspheres. Complete resolution of menorrhagia was achieved in 84% of women at 24 months and significant uterine and fibroid volume reductions were noted after 6 months (37% and 73%, respectively). Three women experienced definitive amenorrhea (4%) and two women required hysteroscopic resection of a fibroid. Eight women were treated by hysterectomy because of treatment failure. In seven of these women, treatment failure was explained by an additional cause of symptoms including diffuse adenomyosis, endometrial hyperplasia or ovarian artery supply to the fibroids.Conclusion: Limited uterine artery embolization using large microspheres has good clinical success rate with low postprocedural pain and complications. Women can expect excellent midterm results with a high level of symptom control and significant fibroid volume reduction. Confidence in the end-point recommended here may require the experience of several cases

Intravascular ultrasound-guided optimized stent deployment. Immediate and 6 months clinical and angiographic results from the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study)

Science.gov (United States)

de Jaegere, P; Mudra, H; Figulla, H; Almagor, Y; Doucet, S; Penn, I; Colombo, A; Hamm, C; Bartorelli, A; Rothman, M; Nobuyoshi, M; Yamaguchi, T; Voudris, V; DiMario, C; Makovski, S; Hausmann, D; Rowe, S; Rabinovich, S; Sunamura, M; van Es, G A

1998-08-01

A study was set up to validate the safety and feasibility of intravascular ultrasound-guided stenting without subsequent anticoagulation, and its impact on the 6 months restenosis rate. The study was designed to be multicentred, prospective, and observational. One hundred and sixty-one patients with stable angina and a de novo coronary artery lesion were enrolled. In four patients, the implantation of a Palmaz-Schatz (with spiral bridge) stent had failed. One of these four patients died 3 days following bypass surgery. In two other patients, intravascular ultrasound assessment was not performed. One hundred and twenty-five of the remaining 155 patients (81%) were treated with aspirin (100 mg x day(-1)), because all three criteria for optimized stent expansion were met. Twenty-two of the remaining 38 patients (25%), in whom at least one criterion was not met were treated with aspirin and acenocoumarol (3 months, INR 2.5-3.5), while 16 patients only received aspirin. Stent thrombosis was documented in two patients (1.3%) for which repeat angioplasty was performed. During the hospital stay, there were no deaths or Q-wave myocardial infarctions. Five patients (3.2%) sustained a non-Q-wave myocardial infarction. During the follow-up period (198+/-38 days, complete for all patients, except one), one patient (0.6%) sustained a Q-wave myocardial infarction, one (0.6%) underwent bypass surgery, and repeat angioplasty was performed in nine patients (5.7%). In two of the nine patients, repeat angioplasty involved another lesion. Therefore, the target lesion revascularization rate during follow-up was 4.5% (seven patients). At quantitative coronary angiography, the minimal lumen diameter (mean+/-SD) increased from 1.12+/-0.34 mm before to 2.89+/-0.35 mm after stenting. Repeat angiography at 6 months was performed in 144 patients (92%). The minimal lumen diameter at follow-up was 2.12+/-0.67 mm. Restenosis (diameter stenosis of 50% or more) was documented in 12 patients or 8

Social capital and the course of depression: six-month prospective cohort study.

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Webber, Martin; Huxley, Peter; Harris, Tirril

2011-03-01

Previous research has found an inverse cross-sectional relationship between an individual's access to social capital (defined as resources embedded within social networks) and depression, but this relationship has not been rigorously tested in prospective research. This is the first longitudinal study to evaluate the effect of social capital on the course of depression and subjective quality of life in a clinical population. This was a six-month prospective cohort study of people with depression in primary care achieving a follow-up rate of 91.3% (n=158). Depression was measured with the HAD-D and social capital using the Resource Generator-UK. Potential confounding variables including socio-demographics, socio-economic status, depression history, social support, life events and attachment style were also measured. Social capital had no independent effect on the course of depression, though an interaction of access to social capital and attachment style was significantly related to change in quality of life alongside multiple covariates. The study used a small sample; a short follow-up period; no measure of ecological social capital; no genetic components; and only two time points. Emotional support is important for the alleviation of depression. Additionally, people with depression may require a secure attachment style to derive the full benefit of their social capital. Copyright © 2010 Elsevier B.V. All rights reserved.

A multicenter randomized controlled trial comparing pancreatic leaks after TissueLink versus SEAMGUARD after distal pancreatectomy (PLATS) NCT01051856.

Science.gov (United States)

Shubert, Christopher R; Ferrone, Christina R; Fernandez-Del Castillo, Carlos; Kendrick, Michael L; Farnell, Michael B; Smoot, Rory L; Truty, Mark J; Que, Florencia G

2016-11-01

Pancreatic leak is common after distal pancreatectomy. This trial sought to compare TissueLink closure of the pancreatic stump to that of SEAMGUARD. A multicenter, prospective, trial of patients undergoing distal pancreatectomy randomized to either TissueLink or SEAMGUARD. Enrollment was closed early due to poor accrual. Overall, 67 patients were enrolled, 35 TissueLink and 32 SEAMGUARD. The two groups differed in American Society of Anesthesiologist class and diagnosis at baseline and were relatively balanced otherwise. Overall, 37 of 67 patients (55%) experienced a leak of any grade, 15 (46.9%) in the SEAMGUARD arm and 22 (62.9%) in the TissueLink arm (P = 0.19). The clinically significant leak rate was 17.9%; 22.9% for TissueLink and 12.5% for SEAMGUARD (P = 0.35). There were no statistically significant differences in major or any pancreatic fistula-related morbidity between the two groups. This is the first multicentered randomized trial evaluating leak rate after distal pancreatectomy between two common transection methods. Although a difference in leak rates was observed, it was not statistically significant and therefore does not provide evidence of the superiority of one technique over the other. Choice should remain based on surgeon comfort, experience, and pancreas characteristics. Copyright © 2016 Elsevier Inc. All rights reserved.

Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study.

Science.gov (United States)

Clemens, Christoph R; Wolf, Armin; Alten, Florian; Milojcic, Carolin; Heiduschka, Peter; Eter, Nicole

2017-11-01

To assess the effects of monthly intravitreal ranibizumab injections in patients with vascularized pigment epithelium detachment (vPED) secondary to age-related macular degeneration (AMD). A total of 40 patients were prospectively observed and treated monthly with 0.5 mg ranibizumab injections (ClinicalTrials.gov Ident. NCT00976222). Inclusion criterion was a treatment-naïve vPED lesion with a minimum height of ≥200 μm. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) were evaluated at all visits. Fluorescein angiography and indocyanine green angiography were performed at baseline and quarterly. Lesions were differentiated between serous vascular PED (svPED, group A, 29 patients) and fibrovascular PED (fPED, group B, 11 patients). Primary outcome was the effectivity of continuous monthly treatment during a 12-month period as measured in change in BCVA. Secondary outcomes were change in PED height and PED greatest linear diameter (GLD). Further secondary outcomes were the presence of subretinal fluid and prognostic markers of an impending retinal pigment epithelium (RPE) tear: PED lesion height and diameter, ratio of choroidal neovascularization (CNV) size to PED size, hyperreflective lines in near-infrared images, microrips and subretinal cleft. Mean BCVA was 56.9 ± 11.5 letters (A: 55.4 ± 10.8; B: 59.1 ± 13.4) at baseline and 55.1 ± 15.9 (A: 53.7 ± 17.0; B: 58.9 ± 12.7) at 12-month follow-up. Excluding the RPE tear patients, the svPED group showed an increase in BCVA from 56.1 ± 10.3 at baseline to 62.4 ± 10.2 at 12-month follow-up (p = 0.048). Best-corrected visual acuity in patient who developed a RPE tear was 55.8 ± 12.5 at baseline and 37.1 ± 14.9 at 12-month follow-up. The mean change in PED height was -242.1 μm ± 285.5 (A: -427.3 μm ± 299.7; B: -51.6 μm ± 99.5). The mean decrease in PED GLD was -471.8 μm ± 727.6 (A: -738.9 μm ± 788.2; B: -10.4�

The 12-month effects of structured lifestyle advice and pelvic floor muscle training for pelvic organ prolapse

DEFF Research Database (Denmark)

Due, Ulla; Brostrøm, Søren; Lose, Gunnar

2016-01-01

INTRODUCTION: We evaluated the 12-month effects of adding pelvic floor muscle training to a lifestyle advice program in women with symptomatic pelvic organ prolapse stage II-III and the number of women who had sought further treatment. MATERIAL AND METHODS: This study was a 12-month follow up...... of a randomized controlled trial comparing a structured lifestyle advice program alone (lifestyle group) or in combination with pelvic floor muscle training (training and lifestyle group). Both programs consisted of six separate group sessions within 12 weeks. RESULTS: Data were available from 83 (76%) of the 109...... surgery. More severe anterior prolapse and more bladder symptoms at the 3-month follow up were significantly associated with having sought further treatment in both groups. CONCLUSIONS: At 12-month follow up, the effects of adding pelvic floor muscle training to a structured lifestyle advice program were...

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...

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.

Reasons for cannabis use in first-episode psychosis: does strength of endorsement change over 12 months?

Science.gov (United States)

Kolliakou, A; Castle, D; Sallis, H; Joseph, C; O'Connor, J; Wiffen, B; Gayer-Anderson, C; McQueen, G; Taylor, H; Bonaccorso, S; Gaughran, F; Smith, S; Greenwood, K; Murray, R M; Di Forti, M; Atakan, Z; Ismail, K

2015-01-01

Why patients with psychosis use cannabis remains debated. The self-medication hypothesis has received some support but other evidence points towards an alleviation of dysphoria model. This study investigated the reasons for cannabis use in first-episode psychosis (FEP) and whether strength in their endorsement changed over time. FEP inpatients and outpatients at the South London and Maudsley, Oxleas and Sussex NHS Trusts UK, who used cannabis, rated their motives at baseline (n=69), 3 months (n=29) and 12 months (n=36). A random intercept model was used to test the change in strength of endorsement over the 12 months. Paired-sample t-tests assessed the differences in mean scores between the five subscales on the Reasons for Use Scale (enhancement, social motive, coping with unpleasant affect, conformity and acceptance and relief of positive symptoms and side effects), at each time-point. Time had a significant effect on scores when controlling for reason; average scores on each subscale were higher at baseline than at 3 months and 12 months. At each time-point, patients endorsed 'enhancement' followed by 'coping with unpleasant affect' and 'social motive' more highly for their cannabis use than any other reason. 'Conformity and acceptance' followed closely. 'Relief of positive symptoms and side effects' was the least endorsed motive. Patients endorsed their reasons for use at 3 months and 12 months less strongly than at baseline. Little support for the self-medication or alleviation of dysphoria models was found. Rather, patients rated 'enhancement' most highly for their cannabis use. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Conversion to belatacept in maintenance kidney-transplant patients: A retrospective multicenter European study.

Science.gov (United States)

Darres, Amandine; Ulloa, Camillo; Brakemeier, Susanne; Garrouste, Cyril; Bestard, Oriol; Del Bello, Arnaud; Sberro Soussan, Rebecca; Dürr, Michael; Budde, Klemens; Legendre, Christophe; Kamar, Nassim

2018-03-22

The use of belatacept is not yet approved for maintenance kidney-transplant patients. This retrospective multicenter European study aimed to assess the efficacy and safety of conversion to belatacept in a large cohort of patients in a real-life setting, and to identify the predictive factors for improved kidney function after the switch. Two-hundred and nineteen maintenance kidney-transplant patients from 5 European kidney-transplant centers were converted to belatacept at 21.2 (0.1-337.1) months posttransplantation, mainly because of impaired kidney function. Thirty-two patients were converted to belatacept within the first 3 months posttransplantation. The mean duration of follow-up was 21.9±20.2 months. The actuarial rate of patients still on belatacept-based therapy was 77.6%. Mean estimated glomerular-filtration rate (eGFR) increased from 32±16.4 at baseline to 38±20 mL/min/1.73 m (ppredictive factor for a significant increase in eGFR (of 5 and 10 mL/min/1.73 m at 3 and 12 months after the switch, respectively). Eighteen patients (8.2%) presented with an acute-rejection episode after conversion; 3 developed a donor-specific antibody (DSA). Overall efficacy and safety were good, including for the 35 patients that had a DSA at conversion. The conversion to belatacept was effective, especially when performed early after transplantation.

12 CFR 1282.18 - Affordability-Income level definitions-family size not known (actual or prospective tenants).

Science.gov (United States)

2010-01-01

....18 Affordability—Income level definitions—family size not known (actual or prospective tenants). In... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Affordability-Income level definitions-family size not known (actual or prospective tenants). 1282.18 Section 1282.18 Banks and Banking FEDERAL...

A multicenter study on objective and subjective benefits with a transcutaneous bone-anchored hearing aid device

DEFF Research Database (Denmark)

Hougaard, Dan Dupont; Boldsen, Soren Kjaergaard; Jensen, Anne Marie

2017-01-01

Examination of objective as well as subjective outcomes with a new transcutaneous bone-anchored hearing aid device. The study was designed as a prospective multicenter consecutive case-series study involving tertiary referral centers at two Danish University Hospitals. A total of 23 patients were...... implanted. Three were lost to follow-up. Patients had single-sided deafness, conductive or mixed hearing loss. Intervention: Rehabilitative. Aided and unaided sound field hearing was evaluated objectively using (1) pure warble tone thresholds, (2) pure-tone average (PTA4), (3) speech discrimination score...... (SDS) in quiet, and (4) speech reception threshold 50% at 70 dB SPL noise level (SRT50%). Subjective benefit was evaluated by three validated questionnaires: (1) the IOI-HA, (2) the SSQ-12, and (3) a questionnaire evaluating both the frequency and the duration of hearing aid usage. The mean aided PTA4...

Prospective study of vaginal dilator use adherence and efficacy following radiotherapy

International Nuclear Information System (INIS)

Law, Ethel; Kelvin, Joanne F.; Thom, Bridgette; Riedel, Elyn; Tom, Ashlyn; Carter, Jeanne; Alektiar, Kaled M.; Goodman, Karyn A.

2015-01-01

Background and purpose: Vaginal stenosis (VS) after pelvic radiotherapy (RT) can impair long-term quality of life. We prospectively assessed adherence and efficacy of vaginal dilator (VD) use in women after pelvic RT. Material and methods: Women with gastrointestinal (n = 63) and gynecologic (n = 46) cancers self-reported use and VD size in monthly diaries for 12 months after radiotherapy. Adherence was measured as actual VD use out of recommended times over 12 months (3×/week × 52 weeks = 156). Results: Among 109 participants, aged 28–81 years (median, 58 years), mean percent adherence over 12 months was 42% (95% confidence interval [CI], 36–48%). Adherence was highest in the first quarter (56%), but fell to 25% by the fourth. Disease type, treatment sequence, and chemotherapy were predictors of adherence (all P < .05). Eighty-two percent maintained pre-RT VD size at 12 months; of 49% with a decrease in VD size at 1 month post-RT, 71% returned to pre-RT VD size at 12 months. Disease type, younger age, and increased adherence at 6 months were associated with maintaining or returning to pre-RT size at 12 months (all P ⩽ .05). Conclusion: VD use is effective in minimizing VS, but adherence at 12 months was poor. Studies evaluating methods of improving adherence and determining the optimal frequency and duration of use are needed

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.

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

Cataract Surgery Outcomes in Uveitis: The Multicenter Uveitis Steroid Treatment Trial.

Science.gov (United States)

Sen, H Nida; Abreu, Francis M; Louis, Thomas A; Sugar, Elizabeth A; Altaweel, Michael M; Elner, Susan G; Holbrook, Janet T; Jabs, Douglas A; Kim, Rosa Y; Kempen, John H

2016-01-01

To assess the visual outcomes of cataract surgery in eyes that received fluocinolone acetonide implant or systemic therapy with oral corticosteroids and immunosuppression during the Multicenter Uveitis Steroid Treatment (MUST) Trial. Nested prospective cohort study of patients enrolled in a randomized clinical trial. Patients that underwent cataract surgery during the first 2 years of follow-up in the MUST Trial. Visual outcomes of cataract surgery were evaluated 3, 6, and 9 months after surgery using logarithmic visual acuity charts. Change in visual acuity over time was assessed using a mixed-effects model. Best-corrected visual acuity. After excluding eyes that underwent cataract surgery simultaneously with implant surgery, among the 479 eyes in the MUST Trial, 117 eyes (28 eyes in the systemic, 89 in the implant group) in 82 patients underwent cataract surgery during the first 2 years of follow-up. Overall, visual acuity increased by 23 letters from the preoperative visit to the 3-month visit (95% confidence interval [CI], 17-29 letters; P uveitis onset, and hypotony were associated with worse preoperative visual acuity (P 0.05, test of interaction). After adjusting for other risk factors, there was no significant difference in the improvement in visual acuity between the 2 treatment groups (implant vs. systemic therapy, 2 letters; 95% CI, -10 to 15 letters; P = 0.70). Cataract surgery resulted in substantial, sustained, and similar visual acuity improvement in the eyes of patients with uveitis treated with the fluocinolone acetonide implant or standard systemic therapy. Published by Elsevier Inc.

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.

Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study.

Science.gov (United States)

Barnes, Darryl E; Beckley, James M; Smith, Jay

2015-01-01

Elbow tendinopathy is the most common cause of elbow pain affecting active populations. Surgical excision is reserved for patients with refractory symptoms. Percutaneous ultrasonic tenotomy performed under local anesthesia also removes degenerated tissue and therefore provides an alternative treatment option to surgical excision. This investigation prospectively documented the safety and 1-year efficacy of ultrasonic percutaneous tenotomy performed by a single operator. Nineteen patients, aged 38 to 67 years, in whom >6 months of conservative management for medial (7) or lateral (12) elbow tendinopathy had failed were prospectively studied. All patients were treated with percutaneous ultrasonic tenotomy of the elbow by a single operator. Visual analog scale (VAS) for pain, the 11-item version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) index, and the Mayo Elbow Performance Score (MEPS) were assessed by an independent observer before treatment and at 6 weeks, 3 months, 6 months, and 12 months after treatment. No procedural complications occurred. Total treatment time was elbow tendinopathy up to 1 year after the procedure. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

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.

A prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes

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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.

Incidence and association factors for the development of chronic post-hysterectomy pain at 4- and 6-month follow-up: a prospective cohort study

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Sng BL

2018-03-01

Full Text Available Ban Leong Sng,1,2 Yin Ying Ching,3 Nian-Lin R Han,4 Farida Binte Ithnin,1 Rehena Sultana,5 Pryseley Nkouibert Assam,6 Alex Tiong Heng Sia1,2 1Department of Women’s Anaesthesia, KK Women’s and Children’s Hospital, Singapore, Singapore; 2Duke-NUS Medical School, Singapore, Singapore; 3Ministry of Health Holdings, Singapore, Singapore; 4Division of Clinical Support Services, KK Women’s and Children’s Hospital, Singapore, Singapore; 5Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore, Singapore; 6Singapore Clinical Research Institute, Singapore, Singapore Abstract: Chronic pain has major adverse effects on health-related quality of life and contributes to significant socioeconomic burden. Hysterectomy is a very common gynecological surgery, resulting in chronic post-hysterectomy pain (CPHP, an important pain syndrome. We conducted a prospective cohort study in 216 Asian women who underwent abdominal or laparoscopic hysterectomy for benign conditions. Demographic, psychological, and perioperative data were recorded. Postoperative 4- and 6-month phone surveys were conducted to assess the presence of CPHP and functional impairment. The incidence rates of CPHP at 4 and 6 months were 32% (56/175 and 15.7% (25/159, respectively. Women with CPHP at 4 and 6 months had pain that interfered with their activities of daily living. Independent association factors for CPHP at 4 months were higher mechanical temporal summation score, higher intraoperative morphine consumption, higher pain score in the recovery room, higher pain score during coughing and itching at 24 hours postoperatively, and preoperative pain in the lower abdominal region. Independent association factors for CPHP at 6 months were preoperative pain during sexual intercourse, higher mechanical temporal summation score, and higher morphine consumption during postoperative 24 and 48 hours. In a majority of cases, CPHP resolved with time, but may have significant impact on

12-month blood pressure results of catheter-based renal artery denervation for resistant hypertension: the SYMPLICITY HTN-3 trial.

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Bakris, George L; Townsend, Raymond R; Flack, John M; Brar, Sandeep; Cohen, Sidney A; D'Agostino, Ralph; Kandzari, David E; Katzen, Barry T; Leon, Martin B; Mauri, Laura; Negoita, Manuela; O'Neill, William W; Oparil, Suzanne; Rocha-Singh, Krishna; Bhatt, Deepak L

2015-04-07

Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure. This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group). Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed. The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg. These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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

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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

Effect of Negative Pressure Wound Therapy vs Standard Wound Management on 12-Month Disability Among Adults With Severe Open Fracture of the Lower Limb: The WOLLF Randomized Clinical Trial.

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Costa, Matthew L; Achten, Juul; Bruce, Julie; Tutton, Elizabeth; Petrou, Stavros; Lamb, Sarah E; Parsons, Nick R

2018-06-12

Open fractures of the lower limb occur when a broken bone penetrates the skin. There can be major complications from these fractures, which can be life-changing. To assess the disability, rate of deep infection, and quality of life in patients with severe open fracture of the lower limb treated with negative pressure wound therapy (NPWT) vs standard wound management after the first surgical debridement of the wound. Multicenter randomized trial performed in the UK Major Trauma Network, recruiting 460 patients aged 16 years or older with a severe open fracture of the lower limb from July 2012 through December 2015. Final outcome data were collected through November 2016. Exclusions were presentation more than 72 hours after injury and inability to complete questionnaires. NPWT (n = 226) in which an open-cell solid foam or gauze was placed over the surface of the wound and connected to a suction pump, creating a partial vacuum over the dressing, vs standard dressings not involving application of negative pressure (n = 234). Disability Rating Index score (range, 0 [no disability] to 100 [completely disabled]) at 12 months was the primary outcome measure, with a minimal clinically important difference of 8 points. Secondary outcomes were complications including deep infection and quality of life (score ranged from 1 [best possible] to -0.59 [worst possible]; minimal clinically important difference, 0.08) collected at 3, 6, 9, and 12 months. Among 460 patients who were randomized (mean age, 45.3 years; 74% men), 88% (374/427) of available study participants completed the trial. There were no statistically significant differences in the patients' Disability Rating Index score at 12 months (mean score, 45.5 in the NPWT group vs 42.4 in the standard dressing group; mean difference, -3.9 [95% CI, -8.9 to 1.2]; P = .13), in the number of deep surgical site infections (16 [7.1%] in the NPWT group vs 19 [8.1%] in the standard dressing group; difference, 1.0% [95

Euclidean supergravity and multi-centered solutions

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W.A. Sabra

2017-04-01

Full Text Available In ungauged supergravity theories, the no-force condition for BPS states implies the existence of stable static multi-centered solutions. The first solutions to Einstein–Maxwell theory with a positive cosmological constant describing an arbitrary number of charged black holes were found by Kastor and Traschen. Generalisations to five and higher dimensional theories were obtained by London. Multi-centered solutions in gauged supergravity, even with time-dependence allowed, have yet to be constructed. In this letter we construct supersymmetry-preserving multi-centered solutions for the case of D=5, N=2 Euclidean gauged supergravity coupled to an arbitrary number of vector multiplets. Higher dimensional Einstein–Maxwell multi-centered solutions are also presented.

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...

Clinical Profile, Etiology, and Treatment of Chronic Pancreatitis in North American Women: Analysis of a Large Multicenter Cohort.

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Romagnuolo, Joseph; Talluri, Jyothsna; Kennard, Elizabeth; Sandhu, Bimaljit S; Sherman, Stuart; Cote, Gregory A; Al-Kaade, Samer; Gardner, Timothy B; Gelrud, Andres; Lewis, Michele D; Forsmark, Christopher E; Guda, Nalini M; Conwell, Darwin L; Banks, Peter A; Muniraj, Thiruvengadam; Wisniewski, Stephen R; Tian, Ye; Wilcox, C Mel; Anderson, Michelle A; Brand, Randall E; Slivka, Adam; Whitcomb, David C; Yadav, Dhiraj

2016-08-01

Historically, chronic pancreatitis (CP) was considered a disease of alcoholic males, but recent data suggest its etiology to be complex. To better understand CP in women, we compared data on women and men with CP in a large, prospectively ascertained multicenter US cohort. Patients with CP enrolled in the NAPS2 Continuation and Validation study were studied. Information on demographics, etiology, risk factors, phenotype, and treatment(s) used was obtained from detailed questionnaires completed by the patients and physicians. Of 521 cases, 45% were women. Women were significantly (P etiology (30% vs 58.5%) and more likely to have nonalcoholic etiologies (idiopathic, 32% vs 18%; obstructive, 12% vs 2.4%; genetic, 12.8% vs 7.3%). Demographics, pain experience, morphologic findings, exocrine and endocrine insufficiency, CP-related disability, and use of medical therapies were mostly similar in both sexes. Sphincterotomy (biliary, 33% vs 24%; pancreatic, 38% vs 28%; P etiologies. In contrast to many other chronic diseases, clinical phenotype of CP is determined by the disease and is independent of sex.

Treatment outcomes after initiation of exenatide twice daily or insulin in clinical practice: 12-month results from CHOICE in six European countries

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Ostenson CG

2013-04-01

Full Text Available Claes-Göran Östenson,1 Stephan Matthaei,2 Matthew Reaney,3 Thure Krarup,4 Bruno Guerci,5 Jacek Kiljanski,6 Carole Salaun-Martin,7 Hélène Sapin,7 David Bruhn,8 Chantal Mathieu,9 Michael Theodorakis10 1Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden; 2Diabetes-Center Quakenbrück, Quakenbrück, Germany; 3Eli Lilly, Windlesham, Surrey, UK; 4Department of Endocrinology I, Bispebjerg Hospital, Copenhagen, Denmark; 5Diabetology, Metabolic Diseases and Nutrition, Brabois Hospital, CHU Nancy, and INSERM CIC, ILCV, Vandoeuvre Lès Nancy, France; 6Eli Lilly, Warsaw, Poland; 7Eli Lilly, Neuilly Cedex, France; 8Eli Lilly, San Diego, California, USA; 9Department of Endocrinology, UZ Gasthuisberg, Leuven, Belgium; 10Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece* *Michael Theodorakis was affiliated with the institution shown at the time of the study, but has since left this institution Objective: The CHanges to treatment and Outcomes in patients with type 2 diabetes initiating InjeCtablE therapy (CHOICE study assessed time to, and reasons for, significant treatment change after patients with type 2 diabetes (T2DM initiated their first injectable glucose-lowering therapy (exenatide twice daily [BID] or insulin in routine clinical practice, and these patients’ clinical outcomes, in six European countries. This paper reports interim data from the first 12 months of the study. Research design and methods: CHOICE (NCT00635492 is a prospective, noninterventional, observational study. Clinical data were collected at initiation of first injectable therapy and after approximately 3, 6, and 12 months. Results: Of 2497 patients enrolled in CHOICE, 1096 in the exenatide BID and 1239 in the insulin cohorts had ≥1 post-baseline assessment and were included in this analysis. Overall, 32.2% of the exenatide BID cohort and 29.1% of the insulin cohort (Kaplan–Meier estimates had

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

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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

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

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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

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

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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.

Cognitive function predicts 24-month weight loss success after bariatric surgery.

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Spitznagel, Mary Beth; Alosco, Michael; Strain, Gladys; Devlin, Michael; Cohen, Ronald; Paul, Robert; Crosby, Ross D; Mitchell, James E; Gunstad, John

2013-01-01

Clinically significant cognitive impairment, particularly in attention/executive and memory function, is found in many patients undergoing bariatric surgery. These difficulties have previously been linked to decreased weight loss 12 months after surgery, but more protracted examination of this relationship has not yet been conducted. The present study prospectively examined the independent contribution of cognitive function to weight loss 24 months after bariatric surgery. Given the rapid rate of cognitive improvement observed after surgery, postoperative cognitive function (i.e., cognition 12 weeks after surgery, controlling for baseline cognition) was expected to predict lower body mass index (BMI) and higher percent total weight loss (%WL) at 24-month follow-up. Data were collected by 3 sites of the Longitudinal Assessment of Bariatric Surgery (LABS) parent project. Fifty-seven individuals enrolled in the LABS project who were undergoing bariatric surgery completed cognitive evaluation at baseline, 12 weeks, and 24 months. BMI and %WL were calculated for 24-month postoperative follow-up. Better cognitive function 12 weeks after surgery predicted higher %WL and lower BMI at 24 months, and specific domains of attention/executive and memory function were robustly related to decreased BMI and greater %WL at 24 months. Results show that cognitive performance shortly after bariatric surgery predicts greater long-term %WL and lower BMI 24 months after bariatric surgery. Further work is needed to clarify the degree to which this relationship is mediated by adherence to postoperative guidelines. Copyright © 2013 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

The effects of using a moldable skin barrier on peristomal skin condition in persons with an ostomy: results of a prospective, observational, multinational study.

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Szewczyk, Maria Teresa; Majewska, Grazyna; Cabral, Mary V; Hölzel-Piontek, Karin

2014-12-01

Peristomal skin problems are the most commonly experienced physical complication following ostomy surgery and often are caused by leakage or a poorly fitting skin barrier. A prospective, multicenter, observational evaluation of persons with a colostomy, ileostomy, or urostomy was conducted to assess the incidence of peristomal lesions and level of patient satisfaction with moldable skin barriers. Peristomal skin was assessed using the Studio Alterazoni Cutanee Stomale (SACS™) scale, and patients were asked to rate barrier application and usage variables. During a period of 12 months, and using convenience sampling, 561 patients from 90 centers in 3 countries were enrolled: 28 in Germany, 48 in Poland, and 14 in the United States. Participants included 277 new stoma patients (average time since surgery 0.3 months; average age 64.7 ± 12.86 years) who had a colostomy (174), ileostomy (72), or urostomy (10); and 284 patients with an existing stoma (average time since surgery 18.2 months; average age 66 ± 12.62 years) who had a colostomy (174), ileostomy (88), or urostomy (22) who experienced skin complications using a traditional skin barrier (ie, a solid or flexible barrier with precut opening or one requiring cutting an opening to accommodate the stoma). All patients were assessed at baseline and after 1 and 2 months. In the patients with a new stoma, 225 (90.4%) had intact skin at baseline, 239 (95.6%) had intact skin after 2 months, and 98% rated overall satisfaction with the barrier as good or excellent. In the patients with an existing stoma, intact skin was observed in 103 patients (39.5%) at baseline and 225 (86.2%) after 2 months, with 96.5% of patients rating overall satisfaction with the barrier as good or excellent. In this group, the proportion of patients who used accessory products (eg, belt, deodorants, powder) was 73% at baseline and 64.2% at the 2-month follow-up. The moldable skin barriers evaluated were effective in preventing and healing

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.)

The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry: design, rationale, and characteristics of patients enrolled in the first 12 months.

Science.gov (United States)

Beukelman, Timothy; Kimura, Yukiko; Ilowite, Norman T; Mieszkalski, Kelly; Natter, Marc D; Burrell, Grendel; Best, Brian; Jones, Jason; Schanberg, Laura E

2017-04-17

Herein we describe the history, design, and rationale of the new Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry and present the characteristics of patients with juvenile idiopathic arthritis (JIA) enrolled in the first 12 months of operation. The CARRA Registry began prospectively collecting data in the United States and Canada in July 2015 to evaluate the safety of therapeutic agents in persons with childhood-onset rheumatic disease, initially restricted to JIA. Secondary objectives include the evaluation of disease outcomes and their associations with medication use and other factors. Data are collected every 6 months and include clinical assessments, detailed medication use, patient-reported outcomes, and safety events. Follow-up is planned for at least 10 years for each participant and is facilitated by a telephone call center. As of July 2016, 1192 patients with JIA were enrolled in the CARRA Registry at 49 clinical sites. At enrollment, their median age was 12.4 years old and median disease duration was 2.6 years. Owing to preferential enrollment, patients with systemic JIA (13%) and with a polyarticular course (75%) were over-represented compared to patients in typical clinical practice. Approximately 49% were currently using biologic agents and ever use of oral glucocorticoids was common (47%). The CARRA Registry provides safety surveillance data to pharmaceutical companies to satisfy their regulatory requirements, and several independently-funded sub-studies that use the Registry infrastructure are underway. The new CARRA Registry successfully enrolled nearly 1200 participants with JIA in the first 12 months of its operation. Sustainable funding has been secured from multiple sources. The CARRA Registry may serve as a model for the study of other uncommon diseases.

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

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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.

Randomized multicenter follow-up trial on the effect of radiotherapy for plantar fasciitis (painful heels spur) depending on dose and fractionation – a study protocol

International Nuclear Information System (INIS)

Holtmann, Henrik; Niewald, Marcus; Prokein, Benjamin; Graeber, Stefan; Ruebe, Christian

2015-01-01

An actual clinical trial showed the effect of low dose radiotherapy in painful heel spur (plantar fasciitis) with single doses of 1.0 Gy and total doses of 6.0 Gy applied twice weekly. Furthermore, a lot of animal experimental and in vitro data reveals the effect of lower single doses of 0.5 Gy which may be superior in order to ease pain and reduce inflammation in patients with painful heel spur. Our goal is therefore to transfer this experimentally found effect into a randomized multicenter trial. This was a controlled, prospective, two-arm phase III-multicenter trial. The standard arm consisted of single fractions of 1.0 Gy applied two times a week, for a total dose of 6.0 Gy (total therapy time: 3 weeks). The experimental arm consisted of single fractions of 0.5 Gy applied 3 times a week, for a total dose of 6.0 Gy (total therapy time: 4 weeks). Following a statistical power calculation, there were 120 patients for each investigation arm. The main inclusion criteria were: age > = 40 years, clinical and radiologically diagnosed painful heel spur (plantar fasciitis), and current symptoms for at least 6 months. The main exclusion criteria were: former local trauma, surgery or radiotherapy of the heel; pregnant or breastfeeding women; and a pre-existing severe psychiatric or psychosomatic disorder. After approving a written informed consent the patients are randomized by a statistician into one of the trial arms. After radiotherapy, the patients are seen after six weeks, after twelve weeks and then every twelve weeks up to 48 weeks. Additionally, they receive a questionnaire every six weeks after the follow-up examinations up to 48 weeks. The effect is measured using the visual analogue scale of pain (VAS), the calcaneodynia score according to Rowe and the SF-12 score. The primary endpoint is the pain relief three months after therapy. Patients of both therapy arms with an insufficient result are offered a second radiotherapy series applying the standard dose

Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE study: findings at 3 months

Directory of Open Access Journals (Sweden)

Reddy RK

2013-09-01

Full Text Available Rahul K Reddy,1 Maziar Lalezary,1 Stephen J Kim,1 Jeffrey A Kammer,1 Rachel W Kuchtey,1 Edward F Cherney,1 Franco M Recchia,2 Karen M Joos,1 Anita Agarwal,1 Janice C Law11Department of Ophthalmology, Vanderbilt University School of Medicine, Nashville, TN, USA; 2Tennessee Retina, PC, Nashville, TN, USABackground: The purpose of this paper is to report the 3-month findings of the Prospective Retinal and Optic Nerve Vitrectomy Evaluation (PROVE study.Methods: Eighty eyes of 40 participants undergoing vitrectomy were enrolled. Participants underwent baseline evaluation of the study (surgical and fellow (control eye that included: intraocular pressure, central corneal thickness, gonioscopy, cup-to-disc ratio measurement, color fundus and optic disc photography, automated perimetry, and optical coherence tomography of the macula and optic nerve. Evaluation was repeated at 3 months. Main outcome measures were changes in macula and retinal nerve fiber layer (RNFL thickness and intraocular pressure.Results: All participants completed follow-up. Mean cup-to-disc ratio of study and fellow eyes at baseline was 0.43 ± 0.2 and 0.46 ± 0.2, respectively, and 13% of participants had undiagnosed narrow angles. There was no significant change in intraocular pressure, cup-to-disc ratio, or pattern standard deviation in study eyes compared with baseline or fellow eyes at 3 months. Vision improved in all study eyes at 3 months compared with baseline (P = 0.013, but remained significantly worse than fellow eyes (P < 0.001. Central subfield and temporal peripapillary RNFL thickness were significantly greater in eyes with epiretinal membrane (P < 0.05, and resolution after surgery correlated with visual improvement (P < 0.05.Conclusion: The 3-month results do not indicate any increased risk for open-angle glaucoma but suggest that a relatively high percentage of eyes may be at risk of angle closure glaucoma. Temporal RNFL thickness and central subfield were increased

Little Words, Big Impact: Determiners Begin to Bootstrap Reference by 12 Months

Science.gov (United States)

Kedar, Yarden; Casasola, Marianella; Lust, Barbara; Parmet, Yisrael

2017-01-01

We tested 12- and 18-month-old English-learning infants on a preferential-looking task which contrasted grammatically correct sentences using the determiner "the" vs. three ungrammatical conditions in which "the" was substituted by another English function word, a nonsense word, or omitted. Our design involved strict controls…

Results from a Prospective, International, Epidemiologic Study of Invasive Candidiasis in Children and Neonates

NARCIS (Netherlands)

Steinbach, W.J.; Roilides, E.; Berman, D.; Hoffman, J.A.; Groll, A.H.; Bin-Hussain, I.; Palazzi, D.L.; Castagnola, E.; Halasa, N.; Velegraki, A.; Dvorak, C.C.; Charkabarti, A.; Sung, L.; Danziger-Isakov, L.; Lachenauer, C.; Arrieta, A.; Knapp, K.; Abzug, M.J.; Ziebold, C.; Lehrnbecher, T.; Klingspor, L.; Warris, A.; Leckerman, K.; Martling, T.; Walsh, T.J.; Benjamin, D.K., Jr.; Zaoutis, T.E.; and the International Pediatric Fungal, N.

2012-01-01

BACKGROUND:: Candida species are the third most common cause of pediatric healthcareassociated bloodstream infection in the United States and Europe. To our knowledge, this report from the International Pediatric Fungal Network is the largest prospective, multi-center observational study dedicated

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…

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.

Late gastrointestinal and urogenital side-effects after radiotherapy – Incidence and prevalence. Subgroup-analysis within the prospective Austrian–German phase II multicenter trial for localized prostate cancer

International Nuclear Information System (INIS)

Schmid, Maximilian P.; Pötter, Richard; Bombosch, Valentin; Sljivic, Samir; Kirisits, Christian; Dörr, Wolfgang; Goldner, Gregor

2012-01-01

Purpose: In general late side-effects after prostate cancer radiotherapy are presented by the use of actuarial incidence rates. The aim of this analysis was to describe additional relevant aspects of late side effects after prostate cancer radiotherapy. Materials and methods: All 178 primary prostate-cancer patients were treated within the Austrian–German multicenter trial by three-dimensional radiotherapy up to a local dose of 70 Gy (low/intermediate-risk) or 74 Gy (high-risk), respectively. Late gastrointestinal/urogenital (GI/GU) side-effects were prospectively assessed by the use of EORTC/RTOG score. Maximum side-effects, actuarial incidence rate and prevalence rates, initial appearance and duration of ⩾grade 2 toxicity were evaluated. Results: Median follow-up was 74 months. Late GI/GU side-effects ⩾grade 2 were detected in 15% (27/178) and 22% (40/178). The corresponding 5-year actuarial incidence rates for GI/GU side-effects were 19% and 23%, whereas the prevalence was 1–2% and 2–7% after 5 years, respectively. Late side effects ⩾grade 2 appeared within 5 years after radiotherapy in all patients with GI side-effects (27/27) and in 85% (34/40) of the patients with GU side-effects, respectively and lasted for less than 3 years in 90% (GI) and 98% (GU). Conclusions: This study demonstrates that the majority of late GI and GU side effects after primary external beam radiotherapy for prostate cancer are transient. Using only actuarial incidence rates for reporting side effects may lead to misinterpretation or overestimation. The combination of incidence and prevalence rates provides a more comprehensive view on the complex issue of late side effects.

Long-term tolerability of tolterodine extended release in children 5-11 years of age: results from a 12-month, open-label study

DEFF Research Database (Denmark)

Nijman, Rien J M; Borgstein, Niels G; Ellsworth, Pamela

2007-01-01

OBJECTIVE: To evaluate the long-term tolerability of tolterodine extended release (ER) in children (aged 5-11 yr) with urgency urinary incontinence (UUI). METHODS: This was a multicenter, open-label extension of a 12-wk, double-blind, placebo-controlled study of tolterodine ER. Patients had UUI...... suggestive of detrusor overactivity (>/=1 diurnal incontinence episode per 24h for >/=5 of 7 d) and >/=6 voids per 24h at baseline and had completed the 12-wk double-blind study. Patients received tolterodine ER (2mg once daily) for 12 mo. The primary end points were the incidence and severity of adverse......-blind tolterodine ER, n=221; placebo, n=97). The majority of patients were white (90%), mean+/-SD age was 7.6+/-1.5 yr, and 54% were boys. Forty-nine percent of patients reported >/=1 AE during the study, similar to that observed in the preceding 12-wk study (42%). The most frequent AEs were urinary tract infection...

PEACE I all-comers registry: patency evaluation after implantation of the 4-French Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions.

Science.gov (United States)

Lichtenberg, Michael; Kolks, Oliver; Hailer, Birgit; Stahlhoff, Wilhelm-Friedrich; Tiefenbacher, Christiane; Nolte-Ernsting, Claus; Arjumand, Jawed; Wittenberg, Guenther

2014-06-01

To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry. Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months. The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (pPulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.

Indirect zirconia-reinforced lithium silicate ceramic CAD/CAM restorations: Preliminary clinical results after 12 months.

Science.gov (United States)

Zimmermann, Moritz; Koller, Christina; Mehl, Albert; Hickel, Reinhard

2017-01-01

No clinical data are available for the new computer-aided design/computer-assisted manufacture (CAD/CAM) material zirconia-reinforced lithium silicate (ZLS) ceramic. This study describes preliminary clinical results for indirect ZLS CAD/CAM restorations after 12 months. Indirect restorations were fabricated, using the CEREC method and intraoral scanning (CEREC Omnicam, CEREC MCXL). Sixty-seven restorations were seated adhesively (baseline). Sixty restorations were evaluated after 12 months (follow-up), using modified FDI criteria. Two groups were established, according to ZLS restorations' post-processing procedure prior to adhesive seating: group I (three-step polishing, n = 32) and group II (fire glazing, n = 28). Statistical analysis was performed with Mann-Whitney U test and Wilcoxon test (P  .05). Statistically significant differences were found for criteria surface gloss for group I and group II (Mann-Whitney U test, P < .05). This study demonstrates ZLS CAD/CAM restorations have a high clinical success rate after 12 months. A longer clinical evaluation period is necessary to draw further conclusions.

Effect of smoking cessation on non-surgical periodontal therapy: Results after 24 months

DEFF Research Database (Denmark)

Francisca Rosa, Ecinele; Corraini, Priscila; Inoue, Gislene

2014-01-01

AIM: The aim of this 24-month prospective study was to assess the effect of smoking cessation on non-surgical periodontal therapy (NSPT) in adult subjects with chronic periodontitis. MATERIALS AND METHODS: Relative to a previous 12-month follow-up study, recruitment and follow-up period were.......05). CONCLUSION: Smoking cessation promoted additional benefits on NSPT in chronic periodontitis subjects....... extended, resulting in 116 eligible among the 286 screened subjects. They received NSPT and concurrent smoking cessation interventions. Periodontal maintenance was performed every three months. A calibrated examined, blinded to smoking status, performed full-mouth periodontal examination in six sites per...

Differential Effects of Acetylcholinesterase Inhibitors on Clinical Responses and Cerebral Blood Flow Changes in Patients with Alzheimer's Disease: A 12-Month, Randomized, and Open-Label Trial

Directory of Open Access Journals (Sweden)

Soichiro Shimizu

2015-04-01

Full Text Available Background/Aims: The present study evaluated the differences in treatment outcomes and brain perfusion changes among 3 types of acetylcholinesterase inhibitors (AchEIs, i.e. donepezil, rivastigmine, and galantamine. Methods: This was a prospective, longitudinal, randomized, open-label, 3-arm (donepezil, rivastigmine, or galantamine, parallel-group, 12-month clinical trial carried out in 55 patients with AD. Results: At 6 months, the results of the Mini-Mental State Examination (MMSE and the Trail Making Test (TMT-Part A showed an improvement versus baseline in the donepezil treatment group. All groups showed a significant increase in regional cerebral blood flow (rCBF, mainly in the frontal lobe. Significant rCBF reduction was observed in the temporal lobe and cingulate gyrus in all 3 groups. Conclusion: AchEI treatment prevents the progression of cognitive impairment and increases the relative rCBF in the frontal lobe.

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…

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.

Anxiety, depression, perceived social support and quality of life in Malaysian breast cancer patients: a 1-year prospective study

OpenAIRE

Ng, Chong Guan; Mohamed, Salina; See, Mee Hoong; Harun, Faizah; Dahlui, Maznah; Sulaiman, Ahmad Hatim; Zainal, Nor Zuraida; Taib, Nur Aishah

2015-01-01

Background Depression and anxiety are common psychiatric morbidity among breast cancer patient. There is a lack of study examining the correlation between depression, anxiety and quality of life (QoL) with perceived social support (PSS) among breast cancer patients. This study aims to study the level of depression, anxiety, QoL and PSS among Malaysian breast cancer women over a period of 12?months and their associations at baseline, 6 and 12?months. Methods It is a 12?months prospective cohor...

[Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).

Science.gov (United States)

Hartholt, Klaas A; Boyé, Nicole D A; Van der Velde, Nathalie; Van Lieshout, Esther M M; Polinder, Suzanne; De Vries, Oscar J; Kerver, Albert J H; Ziere, Gijsbertus; Bruijninckx, Milko M M; De Vries, Mark R; Mattace-Raso, Francesco U S; Uitterlinden, André G; Van Beeck, Ed F; Lips, Paul; Patka, Peter; Van der Cammen, Tischa J M

2011-08-21

Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. The trial is registered in the Netherlands Trial Register (NTR1593).

[Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study

Directory of Open Access Journals (Sweden)

Mattace-Raso Francesco US

2011-08-01

Full Text Available Background Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. Methods/Design A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D, costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. Discussion The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. Trial Registration The trial is registered in the Netherlands Trial Register (NTR1593

A 12-month study of the hikikomori syndrome of social withdrawal: Clinical characterization and different subtypes proposal.

Science.gov (United States)

Malagón-Amor, Ángeles; Martín-López, Luis Miguel; Córcoles, David; González, Anna; Bellsolà, Magda; Teo, Alan R; Pérez, Víctor; Bulbena, Antoni; Bergé, Daniel

2018-03-23

Social withdrawal is a new mental health problem increasingly common, present in different cultures, whose psychopathology and treatment is not yet established. This study aims to determine the socio-demographic and clinical features and possible clinical subtypes that predict the 12-month outcomes of cases with hikikomori syndrome, a severe form of social withdrawal. Socio-demographic and clinical data at baseline were analysed as well as data obtained for 12 months after at-home treatment in 190 cases. The inclusion criteria were: spending all time at home, avoiding social situations and relationships, significant deterioration due to social isolation, with a minimum duration of 6 months. Six major diagnostic groups were identified: affective, anxiety, psychotic, drug use, personality and other Axis I disorders. The anxiety-affective subgroup demonstrated lower clinical severity, but worse evolution. Less than half of the cases were available for medical follow-up at 12-months. Subjects undergoing intensive treatment had a higher medical follow-up rate and better social networks at 12-months. Therefore, our findings provide data to reach consensus on the specific characteristics of social isolation hikikomori syndrome. The analysis demonstrated the fragility and tendency to relapse and have disengagement, particularly relevant in the anxiety-affective subgroup, suggesting that intensive treatments are more effective. Copyright © 2018 Elsevier B.V. All rights reserved.

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

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

The price of donation after cardiac death in liver transplantation : a prospective cost-effectiveness study

NARCIS (Netherlands)

van der Hilst, Christian S.; IJtsma, Alexander J. C.; Bottema, Jan T.; van Hoek, Bart; Dubbeld, Jeroen; Metselaar, Herold J.; Kazemier, Geert; van den Berg, Aad P.; Porte, Robert J.; Slooff, Maarten J. H.

This study aims to perform a detailed prospective observational multicenter cost-effectiveness study by comparing liver transplantations with Donation after Brain Death (DBD) and Donation after Cardiac Death (DCD) grafts. All liver transplantations in the three Dutch liver transplant centers between

A Systematic Review to Define the Speech and Language Benefit of Early (<12 Months) Pediatric Cochlear Implantation.

Science.gov (United States)

Bruijnzeel, Hanneke; Ziylan, Fuat; Stegeman, Inge; Topsakal, Vedat; Grolman, Wilko

2016-01-01

This review aimed to evaluate the additional benefit of pediatric cochlear implantation before 12 months of age considering improved speech and language development and auditory performance. We conducted a search in PubMed, EMBASE and CINAHL databases and included studies comparing groups with different ages at implantation and assessing speech perception and speech production, receptive language and/or auditory performance. We included studies with a high directness of evidence (DoE). We retrieved 3,360 articles. Ten studies with a high DoE were included. Four articles with medium DoE were discussed in addition. Six studies compared infants implanted before 12 months with children implanted between 12 and 24 months. Follow-up ranged from 6 months to 9 years. Cochlear implantation before the age of 2 years is beneficial according to one speech perception score (phonetically balanced kindergarten combined with consonant-nucleus-consonant) but not on Glendonald auditory screening procedure scores. Implantation before 12 months resulted in better speech production (diagnostic evaluation of articulation and phonology and infant-toddler meaningful auditory integration scale), auditory performance (Categories of Auditory Performance-II score) and receptive language scores (2 out of 5; Preschool Language Scale combined with oral and written language skills and Peabody Picture Vocabulary Test). The current best evidence lacks level 1 evidence studies and consists mainly of cohort studies with a moderate to high risk of bias. Included studies showed consistent evidence that cochlear implantation should be performed early in life, but evidence is inconsistent on all speech and language outcome measures regarding the additional benefit of implantation before the age of 12 months. Long-term follow-up studies are necessary to provide insight on additional benefits of early pediatric cochlear implantation. © 2016 S. Karger AG, Basel.

Immediate occlusal loading of Osseotite implants in mandibular edentulous patients: a prospective observational report with 18-month data.

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Drago, Carl J; Lazzara, Richard J

2006-01-01

To evaluate the efficacy of treatment consisting of placement and immediate occlusal loading of implants in 27 patients with edentulous mandibles. Twenty-seven patients were treated in two private practice settings. One hundred fifty-one implants were placed and immediately occlusally loaded with fixed implant prostheses (15 cement-retained, 12 screw-retained) on the day of implant placement. The implant-retained prostheses were inserted within 5 hours of implant placement. Patients were followed for at least 18 months. The required criteria for immediate occlusal loading was primary implant stability of at least 30 Ncm of insertion torque. The implant prostheses were removed at least 12 months post-placement and the implants were evaluated for primary clinical stability and radiographic bone apposition to implants. At the 12-month follow-up appointments, cumulative survival rates of 98.0% and 100% were recorded for implants and prostheses, respectively. Three implants failed within 3 months. All other implants were clinically successful. Immediate occlusal loading of multiple, splinted mandibular implants is an effective treatment when implants are stable at insertion and are rigidly splinted with implant-retained prostheses.

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.

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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.

Nutritional Deficiencies in Children of the First 3 Years of Life, According to a Multicenter Study in Ukraine

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S.L. Nyankovsky

2015-04-01

Full Text Available Taking into account the fact that in Ukraine today there is not enough researches that summarize the data on the nutritional status of young children, the prevalence of eating disorders and lack of basic macro- and micronutrients in children, the multicenter study on nutrition of children from 9 months to 3 years of life has been carried out. It was found that the present dietary intake of infants is unbalanced, contains excess energy and proteins, lack of zinc, iron, calcium, and vitamins A, D, E, B6, B12, B1. Due to unbalanced diet, the use of special infant formula instead of unmodified bovine milk in feeding young child can increase consumption of important nutrients (calcium, iron, iodine, vitamin E, D and folates.

Nutritional Deficiencies in Children of the First 3 Years of Life, According to a Multicenter Study in Ukraine

Directory of Open Access Journals (Sweden)

S.L. Nyankovsky

2013-08-01

Full Text Available Taking into account the fact that in Ukraine today there is not enough researches that summarize the data on the nutritional status of young children, the prevalence of eating disorders and lack of basic macro- and micronutrients in children, the multicenter study on nutrition of children from 9 months to 3 years of life has been carried out. It was found that the present dietary intake of infants is unbalanced, contains excess energy and proteins, lack of zinc, iron, calcium, and vitamins A, D, E, B6, B12, B1. Due to unbalanced diet, the use of special infant formula instead of unmodified bovine milk in feeding young child can increase consumption of important nutrients (calcium, iron, iodine, vitamin E, D and folates.

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

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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.

Distant memories: a prospective study of vantage point of trauma memories.

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Kenny, Lucy M; Bryant, Richard A; Silove, Derrick; Creamer, Mark; O'Donnell, Meaghan; McFarlane, Alexander C

2009-09-01

Adopting an observer perspective to recall trauma memories may function as a form of avoidance that maintains posttraumatic stress disorder (PTSD). We conducted a prospective study to analyze the relationship between memory vantage point and PTSD symptoms. Participants (N= 947) identified the vantage point of their trauma memory and reported PTSD symptoms within 4 weeks of the trauma; 730 participants repeated this process 12 months later. Initially recalling the trauma from an observer vantage point was related to more severe PTSD symptoms at that time and 12 months later. Shifting from a field to an observer perspective a year after trauma was associated with greater PTSD severity at 12 months. These results suggest that remembering trauma from an observer vantage point is related to both immediate and ongoing PTSD symptoms.

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