There was a significant difference in the average extent of union on CT at 10 weeks ( 85 % vs 70 % ) favoring treatment with a cast excluding the thumb .


The overall union rate was 98 % .


The 1 exception was a patient in the thumb immobilization group who elected operative treatment 1 week after enrollment , used crutches , and failed to heal .


There were no significant differences between groups for wrist motion ; grip strength ; Mayo Modified Wrist Score ; Disabilities of the Arm , Shoulder , and Hand score ; or pain intensity .


Immobilization of the thumb appears unnecessary for CT or magnetic resonance image-confirmed nondisplaced or minimally displaced fractures of the waist of the scaphoid .


Therapeutic I.


This study will evaluate hypoxia , as a novel concept in the pathogenesis of diabetic macular oedema ( DMO ) .


As the oxygen demand of the eye is maximum during dark-adaptation , we hypothesize that wearing light-masks during sleep will cause regression and prevent the development and progression of DMO .


The study protocol comprises both an efficacy and mechanistic evaluation to test this hypothesis .


This is a phase III randomised controlled single-masked multicentre clinical trial to test the clinical efficacy of light-masks at preventing dark-adaptation in the treatment of non-central DMO .


Three hundred patients with non-centre-involving DMO in at least one eye will be randomised 1:1 to light-masks and control masks ( with no light ) to be used during sleep at night for a period of 24 months .


The primary outcome is regression of non-central oedema by assessing change in the zone of maximal retinal thickness at baseline on optical coherence tomography ( SD-OCT ) .


Secondary outcomes will evaluate the prevention of development and progression of DMO by assessing changes in retinal thickness in different regions of the macula , macular volume , refracted visual acuity and level of retinopathy .


Safety parameters will include sleep disturbance .


Adverse events and measures of compliance will be assessed over 24 months .


Participants recruited to the mechanistic sub-study will have additional retinal oximetry , multifocal electroretinography ( ERG ) and microperimetry to evaluate the role of hypoxia by assessing and comparing changes induced by supplemental oxygen and the light-masks at 12 months .


The outcomes of this study will provide insight into the pathogenesis of DMO and provide evidence on whether a simple , non-invasive device in the form of a light-mask can help prevent the progression to centre-involving DMO and visual impairment in people with diabetes .


Pain is the primary complaint and the main reason for prolonged recovery after laparoscopic cholecystectomy .


The authors hypothesized that patients undergoing laparoscopic cholecystectomy will have less pain four hours after surgery when receiving maintenance of anesthesia with propofol when compared to isoflurane , desflurane , or sevoflurane .


In this prospective , randomized trial , 80 patients scheduled for laparoscopic cholecystectomy were assigned to propofol , isoflurane , desflurane , or sevoflurane for the maintenance of anesthesia .


Our primary outcome was pain measured on the numeric analog scale four hours after surgery .


We also recorded intraoperative use of opioids as well as analgesic consumption during the first 24h after surgery .


There was no statistically significant difference in pain scores four hours after surgery ( p = 0.72 ) .


There were also no statistically significant differences in pain scores between treatment groups during the 24h after surgery ( p = 0.45 ) .


Intraoperative use of fentanyl and morphine did not vary significantly among the groups ( p = 0.21 and 0.24 , respectively ) .


There were no differences in total morphine and hydrocodone/APAP use during the first 24h ( p = 0.61 and 0.53 , respectively ) .


Patients receiving maintenance of general anesthesia with propofol do not have less pain after laparoscopic cholecystectomy when compared to isoflurane , desflurane , or sevoflurane .


The aim of this study was twofold : First , to assess the personality profile of treatment-seeking adult outpatients with pathological gambling compared to a matched control group under the Alternative Five Factor Model perspective , and second , to determine which personality variables would predict treatment outcome .


The final total sample consisted of 44 consecutive treatment-seeking pathological gamblers ( PGs ) and 88 controls paired by age and sex who completed the Zuckerman-Kuhlman Personality Questionnaire ( ZKPQ ) .


Twelve months after starting an open program of individual cognitive-behavioral therapy , PGs were categorized as abstinent or treatment failure .


PGs scored significantly higher on Neuroticism-Anxiety .


Those who had relapsed or dropped out showed higher Impulsivity and Sensation Seeking scores .


Impulsivity emerged as a significant predictor of treatment failure .


Treatment-seeking PGs scored higher on Neuroticism-Anxiety and Impulsivity appeared as a risk factor of relapsing or dropping out .


Our findings support the importance of individual differences in personality on therapy outcomes .


The ZKPQ may constitute a useful tool to identify these individual differences that might be considered when making personalized treatment decisions to improve the effectiveness and quality of treatment interventions .


The purpose of this study was to determine whether a difference exists in learner performance and the type and frequency of diagnostic reasoning skills used , based on the method of case presentation .


Faculty can select from a variety of methods for presenting cases when teaching diagnostic reasoning , but little evidence exists with regard to how students use these skills while interacting with the cases .


A total of 54 nursing students participated in two case analyses using human patient and computer-based simulations .


Participant performance and diagnostic reasoning skills were analyzed .


Performance was significantly better with the human patient simulation case .


All diagnostic reasoning skills were used during both methods of case presentation , with greater performance variation in the computer-based simulation .


Both human patient and computer-based simulations are beneficial for practicing diagnostic reasoning skills ; however , these findings support the use of human patient simulations for improving student performance in case synthesis .


Given the limitations of prostate specific antigen and standard biopsies for detecting prostate cancer , we evaluated the cancer detection rate and external validity of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system used at the National Institutes of Health .


We performed a phase III trial of a magnetic resonance imaging/transrectal ultrasound fusion guided prostate biopsy system with participants enrolled between 2012 and 2013 .


A total of 153 men consented to the study and underwent 3 Tesla multiparametric magnetic resonance imaging with an endorectal coil for clinical suspicion of prostate cancer .


Lesions were classified as low or moderate/high risk for prostate cancer .


Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy and standard 12-core prostate biopsy were performed and 105 men were eligible for analysis .


Mean patient age was 65.8 years and mean prostate specific antigen was 9.5 ng/ml .


The overall cancer detection rate was 62.9 % ( 66 of 105 patients ) .


The cancer detection rate in those with moderate/high risk on imaging was 72.3 % ( 47 of 65 ) vs 47.5 % ( 19 of 40 ) in those classified as low risk for prostate cancer ( p < 0.05 ) .


Mean tumor core length was 4.6 and 3.7 mm for fusion biopsy and standard 12-core biopsy , respectively ( p < 0.05 ) .


Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy detected prostate cancer that was missed by standard 12-core biopsy in 14.3 % of cases ( 15 of 105 ) , of which 86.7 % ( 13 of 15 ) were clinically significant .


This biopsy upgraded 23.5 % of cancers ( 4 of 17 ) deemed clinically insignificant on 12-core biopsy to clinically significant prostate cancer necessitating treatment .


Magnetic resonance imaging/transrectal ultrasound fusion guided biopsy can improve prostate cancer detection .


The results of this trial support the external validity of this platform and may be the next step in the evolution of prostate cancer management .


Febuxostat , a novel non-purine selective inhibitor of xanthine oxidase , has been identified as a potential alternative to allopurinol in patients with hyperuricemia .


The purpose of this study was to compare the urate-lowering ( UL ) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia .


Gout patients ( n = 512 ) with serum uric acid ( sUA ) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40mg or 80mg or allopurinol 300mg for 28weeks .


Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8 .


The primary endpoint was the percentage of subjects achieving a sUA concentration of < 6.0 mg/dL at the last three monthly measurements .


The primary endpoint was reached in 44.77 % of patients receiving 80mg of febuxostat , 27.33 % of those receiving 40mg of febuxostat , and 23.84 % of those receiving allopurinol .


The UL efficacy in the febuxostat 80mg group was higher than in the allopurinol ( P < 0.0001 ) and febuxostat 40mg ( P = 0.0008 ) groups .


The UL efficacy of the febuxostat 40mg group was statistically non-inferior to that of the allopurinol group .


No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group .


The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups .


The UL efficacy of daily febuxostat 80mg was greater than that of febuxostat 40mg and allopurinol 300mg , which exhibited comparable UL efficacy .


Safety of febuxostat and allopurinol was comparable at the doses tested .


Effective functioning of the neurotransmitter serotonin is important for optimal cognitive and emotional function .


Dietary supplements able to increase availability to the brain of the precursor amino acid , tryptophan ( TRP ) , and thereby enhance serotonin synthesis , can have measurable impact on these psychological processes .


This study involves a randomised controlled trial of a TRP-rich egg-white protein hydrolysate ( DSM Nutritional Products Ltd. , Switzerland ) on plasma amino acids , cognition , mood and emotional processing in older women .


Following a baseline test day without treatment , 60 healthy women aged 45-65 years received drinks containing either 2 or 4 g of TRP-rich protein hydrolysate product or 3.11 g casein hydrolysate as a control .


One hour later , they undertook a 2-h battery of cognitive and emotional tests .


The TRP-rich protein hydrolysate produced the expected dose-dependent increase in the ratio of plasma TRP to competing large neutral amino acids .


TRP-rich protein hydrolysate ( 2 g only ) prevented both the decline in wellbeing and increase in fatigue seen over the test session in the control group .


This treatment dose resulted in a significant shift in emotional processing towards positive words and reduced negative bias in assessing negative facial expressions .


Effects on cognition were small and not statistically reliable and are not reported here .


However , there was no evidence for any adverse effects .


Consumption of a low dose of TRP-rich protein hydrolysate may have beneficial effects on emotional function that could promote feelings of wellbeing , possibly conferring resistance to deterioration in mood in healthy subjects or depressive episodes .


There is concern that combining energy drinks with alcohol may ` mask ' subjective intoxication leading to greater alcohol consumption .


This study examines the effects of alcohol alone and combined with energy drink on objective and subjective intoxication and mood over the course of 3h .


Using a double-blind , placebo-controlled , balanced , crossover design , 24 participants ( mean age 22.23 years ) were administered with double placebo , 0.6 g/kg alcohol ( mean peak blood alcohol content of 0.051 % ) , 250ml energy drink and alcohol/energy drink , according to a Latin square design , with a washout of > 48h .


On each visit , they were breathalysed and rated themselves on a comprehensive battery of mood items at baseline and then at 45 , 90 and 180min post-drink .


Blood alcohol and subjective intoxication were significantly increased following both alcohol alone and alcohol/energy drink .


Both measures were statistically indistinguishable between alcohol conditions .


In keeping with its ( 80mg ) caffeine content , the energy drink alone significantly increased self-rated ` alertness ' and reduced ` depression-dejection ' scores compared with the combined alcohol/energy drink .


The alcohol/energy drink increased ` vigor ' and ` contentment ' at 45min and decreased ` contentment ' at 180min .


The co-ingestion of an energy drink with alcohol does not differently influence blood alcohol content recordings or subjective intoxication compared with alcohol alone , although some mood items are differentially affected .


Simethicone and N-acetylcysteine have been widely used in improving endoscopic visibility .


However , the optimal dose , volume , and dosing time for the premedication regimen are still unclear .


Our aim was to assess the efficacy of premedication in improving endoscopic visibility and determine the contributions of dose , volume , and premedication time .


A total of 1849 patients were prospectively treated in three groups : group A : 100-mg simethicone suspension in 5 mL water ; group B : 100-mg simethicone suspension in 100 mL water ; and group C : 100-mg simethicone suspension in 100 mL water containing 200 mg N-acetylcysteine .


Mucosa visibility was assessed at seven sites of upper gastrointestinal tract .


The sum of scores was considered as total mucosal visibility score ( TMVS ) .


The upper body of stomach had the worst visibility score for all groups .


TMVS of groups B and C were significantly lower than those of group A. Group C had a significantly fewer patients requiring endoscopic flushing than groups A and B.


The TMVS for groups B and C were significantly lower than for group A within 30 min of beginning premedication .


Beyond 30 min of premedication , there was no significant difference in the TMVS among groups .


Premedication using 100 mg simethicone in 100 mL of water improves endoscopic visibility .


Addition of N-acetylcysteine to simethicone in 100 mL of water reduces the need for endoscopic flushing .


For patients unable to tolerate a large fluid volume , a 5-mL simethicone suspension administered more than 30 min prior to upper endoscopy is suggested .


The aim of this study was to evaluate the remineralization effect of Casein Phosphopeptid Amorphous Calcium Phosphate ( CPP-ACP ) on white spot lesions ( WSL ) and its inhibitory effect on Streptococcus mutans colonization .


The study group consisted of 60 children exhibiting at least 1-WSL .


Subjects were randomly divided into 2 groups : a test group of using CPP-ACP cream ( Tooth Mousse , GC Europe N.V. , Leuven , Belgium ) and a control group using only fluoride containing toothpaste for a period of 3-months .


Baseline WSLs were scored using DIAGNOdent device ( KaVo Germany ) and the saliva samples were collected to measure S. mutans counts .


After the 3-month period the WSLs were again recorded and the saliva sample collection was repeated .


Wilcoxon Signed Ranks Test was used for statistical analysis .


DIAGNOdent measurements were increased by time ( p = 0.002 ) in control group and no statistically significant diference ( p = 0.217 ) was found in test group by the 3-month period .


In both groups , the mutans counts were decreased in 3-month experimental period .


These clinical and laboratory results suggested that CPP-ACP containing cream had a slight remineralization effect on the WSL in the 3-month evaluation period however longer observation is recommended to confirm whether the greater change in WSLs is maintained .


The endomyocardial biopsy ( EMB ) is considered the gold standard in rejection surveillance post cardiac transplant , but is invasive , with risk of complications .


A previous trial suggested that the gene expression profiling ( GEP ) blood test was noninferior to EMB between 6 and 60 months post transplant .


As most rejections occur in the first 6 months , we conducted a single-center randomized trial of GEP versus EMB starting at 55 days post transplant ( when GEP is valid ) .


Sixty heart transplant patients meeting inclusion criteria were randomized beginning at 55 days post transplant to either GEP or EMB arms .


A positive GEP 30 between 2 and 6 months , or 34 after 6 months , prompted a follow-up biopsy .


The primary end point included a composite of death/retransplant , rejection with hemodynamic compromise or graft dysfunction at 18 months post transplant .


A coprimary end point included change in first-year maximal intimal thickness by intravascular ultrasound , a recognized surrogate for long-term outcome .


Corticosteroid weaning was assessed in both the groups .


The composite end point was similar between the GEP and EMB groups ( 10 % versus 17 % ; log-rank P = 0.44 ) .


The coprimary end point of first-year intravascular ultrasound change demonstrated no difference in mean maximal intimal thickness ( 0.350.36 versus 0.360.26 mm ; P = 0.944 ) .


Steroid weaning was successful in both the groups ( 91 % versus 95 % ) .


In this pilot study , GEP starting at 55 days post transplant seems comparable with EMB for rejection surveillance in selected heart transplant patients and does not result in increased adverse outcomes .


GEP also seems useful to guide corticosteroid weaning .


Larger randomized trials are required to confirm these findings .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT014182482377 .


Short-term advantages to laparoscopic surgery are well described .


This study compared medium - to long-term outcomes of a randomized clinical trial comparing laparoscopic and open colonic resection for cancer .


The case notes of patients included in the LAFA study ( perioperative strategy in colonic surgery ; LAparoscopy and/or FAst track multimodal management versus standard care ) were reviewed 2-5years after randomization for incisional hernia , adhesional small bowel obstruction ( SBO ) , overall survival , cancer recurrence and quality of life ( QoL ) .


The laparoscopic and open groups were compared irrespective of fast-track or standard perioperative care .


Data on incisional hernias , SBO , survival and recurrence were available for 399 of 400 patients : 208 laparoscopic and 191 open resections .


These outcomes were corrected for duration of follow-up .


Median follow-up was 34 ( i.q.r. 26-44 ) years .


Multivariable regression analysis showed that open resection was a risk factor for incisional hernia ( odds ratio ( OR ) 244 , 95 per cent confidence interval ( c.i. ) 112 to 526 ; P = 0022 ) and SBO ( OR 370 , 107 to 1250 ; P = 0039 ) .


There were no differences in overall survival ( hazard ratio 110 , 95 per cent c.i. 067 to 180 ; P = 0730 ) or in cumulative incidence of recurrence ( P = 0514 ) between the laparoscopic and open groups .


There were no measured differences in QoL in 281 respondents ( P > 0350 for all scales ) .


Laparoscopic colonic surgery led to fewer incisional hernia and adhesional SBO events .


NTR222 ( http://www.trialregister.nl ) .


Past studies that demonstrated that sexual dysfunction is common among women receiving chronic hemodialysis did not distinguish sexual dysfunction/difficulty from sexual inactivity .


This study sought to differentiate these in order to elucidate the prevalence of true `` sexual dysfunction '' in this population .


As part of a clinical trial of symptom management strategies in patients receiving chronic hemodialysis , female sexual function was prospectively assessed monthly for 6 months and quarterly thereafter using the Female Sexual Function Index , to which questions were added differentiating sexual dysfunction/difficulty from sexual inactivity .


Beginning in month 7 , patients were asked three questions about sexual activity , difficulty , and satisfaction monthly .


Of the women enrolled in the clinical trial ,125 participants completed 1721 assessments between 2009 and 2011 .


Scores on 574 of 643 ( 89 % ) quarterly Female Sexual Function Index assessments were consistent with sexual dysfunction , due largely to sexual inactivity , which was reported on 525 ( 82 % ) quarterly assessments .


When reported ( n = 1663 ) , the most frequently described reasons for sexual inactivity were lack of interest in sex ( n = 715 ; 43 % ) and lack of a partner ( n = 647 ; 39 % ) , but rarely sexual difficulty ( n = 36 ; 2 % ) .


When reported ( n = 1582 ) , women were moderately to very satisfied with their sexual life on 1020 ( 64 % ) assessments and on 513 of 671 ( 76 % ) assessments in which lack of interest was cited as a reason for sexual inactivity .


Women indicated an interest in learning about the causes of and treatment for sexual dysfunction on just 5 % of all assessments .


Although many women receiving chronic hemodialysis are sexually inactive , few describe sexual difficulty .


Most , including those with a lack of interest in sex , are satisfied with their sexual life and few wish to learn about treatment options .


These findings suggest that true sexual dysfunction is uncommon in this population and that treatment opportunities are rare .


To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease ( COPD ) compared with usual care .


24 month , multicentre , pragmatic cluster randomised controlled trial


40 general practices in the western part of the Netherlands


Patients with COPD according to GOLD ( Global Initiative for COPD ) criteria .


Exclusion criteria were terminal illness , cognitive impairment , alcohol or drug misuse , and inability to fill in Dutch questionnaires .


Practices were included if they were willing to create a multidisciplinary COPD team .


General practitioners , practice nurses , and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice , including early recognition of exacerbations and self management , smoking cessation , physiotherapeutic reactivation , optimal diagnosis , and drug adherence .


Additionally , the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice .


The control group continued usual care ( based on international guidelines ) .


The primary outcome was difference in health status at 12 months , measured by the Clinical COPD Questionnaire ( CCQ ) ; quality of life , Medical Research Council dyspnoea , exacerbation related outcomes , self management , physical activity , and level of integrated care ( PACIC ) were also assessed as secondary outcomes .


Of a total of 1086 patients from 40 clusters , 20 practices ( 554 patients ) were randomly assigned to the intervention group and 20 clusters ( 532 patients ) to the usual care group .


No difference was seen between groups in the CCQ at 12 months ( mean difference -0.01 , 95 % confidence interval -0.10 to 0.08 ; P = 0.8 ) .


After 12 months , no differences were seen in secondary outcomes between groups , except for the PACIC domain `` follow-up/coordination '' ( indicating improved integration of care ) and proportion of physically active patients .


Exacerbation rates as well as number of days in hospital did not differ between groups .


After 24 months , no differences were seen in outcomes , except for the PACIC follow-up/coordination domain .


In this pragmatic study , an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care , except improved level of integrated care and a self reported higher degree of daily activities .


The contradictory findings to earlier positive studies could be explained by differences between interventions ( provider versus patient targeted ) , selective reporting of positive trials , or little room for improvement in the already well developed Dutch healthcare system .


Netherlands Trial Register NTR2268 .


Malaria is a leading cause of morbidity and mortality among young children and is estimated to cause at least 1 million deaths each year especially among pregnant women and young children under the age of five years .


Vitamin A supplementation is known to reduce morbidity and mortality in young children .


Zinc is required for growth and immunity and we sought to replicate the study by Zeba et al. which showed 30 % lower cases of clinical malaria in children on a combination of zinc and a large dose of vitamin A compared with children on vitamin A alone based on the hypothesis that combined vitamin A and zinc reduced symptomatic malaria compared to vitamin A alone .


The primary objective was to determine the effect of vitamin A alone vs. vitamin A and zinc supplements on the incidence of clinical malaria and other anthropometric indices .


It also sought to assess the effects on the incidence of anaemia , diarrhoea and pneumonia .


The study was community-based and 200 children between the ages of 6-24 months were randomised to receive either vitamin A ( 100,000 IU for infants less than 12 months & 200,000 IU for children greater than 12 months and 10 mg daily zinc in the intervention group or vitamin A and zinc placebo for 6 months in the control group .


The number of children who were diagnosed with uncomplicated malaria in the intervention group was 27 % significantly lower compared with the children in the control group ( p = 0.03 ) .


There were , however , no effects on severe malaria , pneumonia , anaemia and diarrhea .


Our study confirms a significant role of vitamin A and zinc in reducing malaria morbidity .


Preventing and rehabilitating gait disorders in people with dementia during early disease stage is of high importance for staying independent and ambulating safely .


However , the evidence gathered in randomized controlled trials ( RCTs ) on the effectiveness of exercise training for improving spatio-temporal gait parameters in people with dementia is scarce .


The aim of the present study was to determine whether a specific , standardized training regimen can improve gait characteristics in people with dementia .


Sixty-one individuals ( mean age : 81.9 years ) with confirmed mild to moderate stage dementia took part in a 3-month double-blinded outpatient RCT .


Subjects in the intervention group ( IG ) received supervised , progressive resistance and functional group training for 3 months ( 2 times per week for two hours ) specifically developed for people with dementia .


Subjects in the control group ( CG ) conducted a low-intensity motor placebo activity program .


Gait characteristics were measured before and after the intervention period using a computerized gait analysis system ( GAITRite ) .


Adherence to the intervention was excellent , averaging 91.9 % in the IG and 94.4 % in the CG .


The exercise training significantly improved gait speed ( P < 0.001 ) , cadence ( P = 0.002 ) , stride length ( P = 0.008 ) , stride time ( P = 0.001 ) , and double support ( P = 0.001 ) in the IG compared to the CG .


Effect sizes were large for all gait parameters that improved significantly ( Cohen 's d : 0.80-1 .27 ) .


No improvements were found for step width ( P = 0.999 ) , step time variability ( P = 0.425 ) and Walk-Ratio ( P = 0.554 ) .


Interestingly , low baseline motor status , but not cognitive status , predicted positive training response ( relative change in gait speed from baseline ) .


The intensive , dementia-adjusted training was feasible and improved clinically meaningful gait variables in people with dementia .


The exercise program may represent a model for preventing and rehabilitating gait deficits in the target group .


Further research is required for improving specific gait characteristics such as gait variability in people with dementia .


ISRCTN49243245 .


Palliative care patients and their family caregivers may have a foreshortened perspective of the time left to live , or the expectation of the patient 's death in the near future .


Patients and caregivers may report distress in physical , psychological , or existential/spiritual realms .


To conduct a randomized controlled trial examining the effectiveness of retired senior volunteers ( RSVs ) in delivering a reminiscence and creative activity intervention aimed at alleviating palliative care patient and caregiver distress .


Of the 45 dyads that completed baseline assessments , 28 completed postintervention and 24 completed follow-up assessments .


The intervention group received three home visits by RSVs ; control group families received three supportive telephone calls by the research staff .


Measures included symptom assessment and associated burden , depression , religiousness/spirituality , and meaning in life .


Patients in the intervention group reported a significantly greater reduction in frequency of emotional symptoms ( P = 0.02 ) and emotional symptom bother ( P = 0.04 ) than the control group , as well as improved spiritual functioning .


Family caregivers in the intervention group were more likely than control caregivers to endorse items on the Meaning of Life Scale ( P = 0.02 ) .


Only improvement in intervention patients ' emotional symptom bother maintained at follow-up after discontinuing RSV contact ( P = 0.024 ) .


Delivery of the intervention by RSVs had a positive impact on palliative care patients ' emotional symptoms and burden and caregivers ' meaning in life .


Meaningful prolonged engagement with palliative care patients and caregivers , possibly through alternative modes of treatment delivery such as continued RSV contact , may be necessary for maintenance of therapeutic effects .


Postoperative pancreatic fistula is a major contributor to complications and death associated with pancreatic resection .


Pasireotide , a somatostatin analogue that has a longer half-life than octreotide and a broader binding profile , decreases pancreatic exocrine secretions and may prevent postoperative pancreatic fistula .


We conducted a single-center , randomized , double-blind trial of perioperative subcutaneous pasireotide in patients undergoing either pancreaticoduodenectomy or distal pancreatectomy .


We randomly assigned 300 patients to receive 900 g of subcutaneous pasireotide ( 152 patients ) or placebo ( 148 patients ) twice daily beginning preoperatively on the morning of the operation and continuing for 7 days ( 14 doses ) .


Randomization was stratified according to the type of resection and whether the pancreatic duct was dilated at the site of transection .


The primary end point was the development of pancreatic fistula , leak , or abscess of grade 3 or higher ( i.e. , requiring drainage ) .


The primary end point occurred in 45 of the 300 patients ( 15 % ) .


The rate of grade 3 or higher postoperative pancreatic fistula , leak , or abscess was significantly lower among patients who received pasireotide than among patients who received placebo ( 9 % vs. 21 % ; relative risk , 0.44 ; 95 % confidence interval [ CI ] , 0.24 to 0.78 ; P = 0.006 ) .


This finding was consistent among 220 patients who underwent pancreaticoduodenectomy ( 10 % vs. 21 % ; relative risk , 0.49 ; 95 % CI , 0.25 to 0.95 ) and 80 patients who underwent distal pancreatectomy ( 7 % vs. 23 % ; relative risk , 0.32 ; 95 % CI , 0.10 to 0.99 ) , as well as among 136 patients with a dilated pancreatic duct ( 2 % vs. 15 % ; relative risk , 0.11 ; 95 % CI , 0.02 to 0.60 ) and 164 patients with a nondilated pancreatic duct ( 15 % vs. 27 % ; relative risk , 0.55 ; 95 % CI , 0.29 to 1.01 ) .


Perioperative treatment with pasireotide decreased the rate of clinically significant postoperative pancreatic fistula , leak , or abscess .


( Funded by Novartis Pharmaceuticals ; ClinicalTrials.gov number , NCT00994110 . )


On the basis of phase II trials , we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke .


We studied transcranial laser therapy in a double-blind , sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated 24 hours after stroke onset and who did not undergo thrombolytic therapy .


The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale , with hierarchical Bayesian analysis incorporating relevant previous data .


Interim analyses were planned after 300 and 600 patients included .


The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point ( transcranial laser therapy 140/282 [ 49.6 % ] versus sham 140/284 [ 49.3 % ] for good functional outcome ; modified Rankin Scale , 0-2 ) .


The results remained stable after inclusion of all 630 randomized patients ( adjusted odds ratio , 1.024 ; 95 % confidence interval , 0.705-1 .488 ) .


Once the results of the interim futility analysis became available , all study support was immediately withdrawn by the capital firms behind PhotoThera , and the company was dissolved .


Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera , the CRO Parexel and members of the steering and the safety committees .


We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset .


http://www.clinicaltrials.gov .


Unique identifier : NCT01120301 .


The frailty syndrome is as a well-established condition of risk for disability .


Aim of the study is to explore whether a physical activity ( PA ) intervention can reduce prevalence and severity of frailty in a community-dwelling elders at risk of disability .


Exploratory analyses from the Lifestyle Interventions and Independence for Elders pilot , a randomized controlled trial enrolling 424 community-dwelling persons ( mean age = 76.8 years ) with sedentary lifestyle and at risk of mobility disability .


Participants were randomized to a 12-month PA intervention versus a successful aging education group .


The frailty phenotype ( ie , 3 of the following defining criteria : involuntary weight loss , exhaustion , sedentary behavior , slow gait speed , poor handgrip strength ) was measured at baseline , 6 months , and 12 months .


Repeated measures generalized linear models were conducted .


A significant ( p = .01 ) difference in frailty prevalence was observed at 12 months in the PA intervention group ( 10.0 % ; 95 % confidence interval = 6.5 % , 15.1 % ) , relative to the successful aging group ( 19.1 % ; 95 % confidence interval = 13.9 % ,15.6 % ) .


Over follow-up , in comparison to successful aging participants , the mean number of frailty criteria in the PA group was notably reduced for younger subjects , blacks , participants with frailty , and those with multimorbidity .


Among the frailty criteria , the sedentary behavior was the one most affected by the intervention .


Regular PA may reduce frailty , especially in individuals at higher risk of disability .


Future studies should be aimed at testing the possible benefits produced by multidomain interventions on frailty .


Past traumatic events have been associated with poorer clinical outcomes in people with bipolar disorder .


However , the impact of these events in the early stages of the illness remains unclear .


The aim of this study was to investigate whether prior traumatic events were related to poorer outcomes 12 months following a first episode of psychotic mania .


Traumatic events were retrospectively evaluated from patient files in a sample of 65 participants who had experienced first episode psychotic mania .


Participants were aged between 15 and 28 years and were treated at a specialised early psychosis service .


Clinical outcomes were measured by a variety of symptomatic and functioning scales at the 12-month time-point .


Direct-personal traumatic experiences prior to the onset of psychotic mania were reported by 48 % of the sample .


Participants with past direct-personal trauma had significantly higher symptoms of mania ( p = 0.02 ) , depression ( p = 0.03 ) and psychopathology ( p = 0.01 ) 12 months following their first episode compared to participants without past direct-personal trauma , with medium to large effects observed .


After adjusting for baseline scores , differences in global functioning ( as measured by the Global Assessment of Functioning scale ) were non-significant ( p = 0.05 ) ; however , participants with past direct-personal trauma had significantly poorer social and occupational functioning ( p = 0.04 ) at the 12-month assessment with medium effect .


Past direct-personal trauma may predict poorer symptomatic and functional outcomes after first episode psychotic mania .


Limitations include that the findings represent individuals treated at a specialist early intervention centre for youth and the retrospective assessment of traumatic events may have been underestimated .


Saline ( 0.9 % sodium chloride ) is the most commonly administered intravenous fluid ; however , its use may be associated with acute kidney injury ( AKI ) and increased mortality .


To determine the effect of a buffered crystalloid compared with saline on renal complications in patients admitted to the intensive care unit ( ICU ) .


Double-blind , cluster randomized , double-crossover trial conducted in 4 ICUs in New Zealand from April 2014 through October 2014 .


Three ICUs were general medical and surgical ICUs ; 1 ICU had a predominance of cardiothoracic and vascular surgical patients .


All patients admitted to the ICU requiring crystalloid fluid therapy were eligible for inclusion .


Patients with established AKI requiring renal replacement therapy ( RRT ) were excluded .


All 2278 eligible patients were enrolled ; 1152 of 1162 patients ( 99.1 % ) receiving buffered crystalloid and 1110 of 1116 patients ( 99.5 % ) receiving saline were analyzed .


Participating ICUs were assigned a masked study fluid , either saline or a buffered crystalloid , for alternating 7-week treatment blocks .


Two ICUs commenced using 1 fluid and the other 2 commenced using the alternative fluid .


Two crossovers occurred so that each ICU used each fluid twice over the 28 weeks of the study .


The treating clinician determined the rate and frequency of fluid administration .


The primary outcome was proportion of patients with AKI ( defined as a rise in serum creatinine level of at least 2-fold or a serum creatinine level of 3.96 mg/dL with an increase of 0.5 mg/dL ) ; main secondary outcomes were incidence of RRT use and in-hospital mortality .


In the buffered crystalloid group , 102 of 1067 patients ( 9.6 % ) developed AKI within 90 days after enrollment compared with 94 of 1025 patients ( 9.2 % ) in the saline group ( absolute difference , 0.4 % [ 95 % CI , -2.1 % to 2.9 % ] ; relative risk [ RR ] , 1.04 [ 95 % CI , 0.80 to 1.36 ] ; P = .77 ) .


In the buffered crystalloid group , RRT was used in 38 of 1152 patients ( 3.3 % ) compared with 38 of 1110 patients ( 3.4 % ) in the saline group ( absolute difference , -0.1 % [ 95 % CI , -1.6 % to 1.4 % ] ; RR , 0.96 [ 95 % CI , 0.62 to 1.50 ] ; P = .91 ) .


Overall , 87 of 1152 patients ( 7.6 % ) in the buffered crystalloid group and 95 of 1110 patients ( 8.6 % ) in the saline group died in the hospital ( absolute difference , -1.0 % [ 95 % CI , -3.3 % to 1.2 % ] ; RR , 0.88 [ 95 % CI , 0.67 to 1.17 ] ; P = .40 ) .


Among patients receiving crystalloid fluid therapy in the ICU , use of a buffered crystalloid compared with saline did not reduce the risk of AKI .


Further large randomized clinical trials are needed to assess efficacy in higher-risk populations and to measure clinical outcomes such as mortality .


clinicaltrials.gov Identifier : ACTRN12613001370796 .


To observe the clinical effect of Lingtong Capsule ( LC ) in treating primary dysmenorrhea ( PD ) .


Totally 59 PD patients took LC , while 59 patients in the placebo group took placebo capsule , two pills immediately when they felt dysmenorrhea .


Their pain levels were quantitatively classified .


The pain score was assessed at an interval of 30 min using visual analogue scale/score ( VAS ) while taking medicine and within two h after taking medicine .


It was assessed as effective when the pain level was reduced by more than or equal to 50 % within 2 h.


The total effective rate was 69.49 % ( 41 / 59 ) in the LC group and 20.34 % ( 12/59 ) in the placebo group ( P < 0.01 ) .


The analgesia effect was obviously superior in the LC group 60 min after taking medicine ( P < 0.01 ) .


LC showed better effect in treating mild , moderate , and severe PD ( P < 0.05 ) .


LC showed obvious analgesia effect on PD .


Increased risk of osteoporosis and its clinical significance in patients with diabetes is controversial .


We analyze osteoporosis prevalence and determinants of bone mineral density ( BMD ) in patients with type 1 and 2 diabetes .


Three hundred and ninety-eight consecutive diabetic patients from a single outpatient clinic received a standardized questionnaire on osteoporosis risk factors , and were evaluated for diabetes-related complications , HbA1c levels , and lumbar spine ( LS ) and femoral neck ( FN ) BMD .


Of these , 139 ( 71 men , 68 women ) type 1 and 243 ( 115 men , 128 women ) type 2 diabetes patients were included in the study .


BMD ( T-scores and values adjusted for age , BMI and duration of disease ) was compared between patient groups and between patients with type 2 diabetes and population-based controls ( 255 men , 249 women ) .


For both genders , adjusted BMD was not different between the type 1 and type 2 diabetes groups but was higher in the type 2 group compared with controls ( p < 0.0001 ) .


Osteoporosis prevalence ( BMD T-score < -2.5 SD ) at FN and LS was equivalent in the type 1 and type 2 diabetes groups , but lower in type 2 patients compared with controls ( FN : 13.0 % vs 21.2 % , LS : 6.1 % vs 14.9 % men ; FN : 21.9 % vs 32.1 % , LS : 9.4 % vs 26.9 % women ) .


Osteoporosis prevalence was higher at FN-BMD than at LS-BMD .


BMD was positively correlated with BMI and negatively correlated with age , but not correlated with diabetes-specific parameters ( therapy , HbBA1c , micro - and macrovascular complications ) in all subgroups .


Fragility fracture prevalence was low ( 5.2 % ) and not different between diabetes groups .


Fracture patients had lower BMDs compared with those without fractures ; however , BMD T-score was above -2.5 SD in most patients .


Diabetes-specific parameters did not predict BMD .


Fracture occurrence was similar in both diabetes groups and related to lower BMD , but seems unrelated to the threshold T-score , < -2.5 SD .


These results suggest that osteoporosis , and related fractures , is a clinically significant and commonly underestimated problem in diabetes patients .


Lumbar punctures are frequently performed in pediatric leukemia for central nervous system leukemic prophylaxis .


The contribution of local anesthetic with deep sedation is unknown .


The objective was to evaluate EMLA ( eutectic mixture of local anesthetics ) cream as a pain reliever in conjunction with propofol in the setting of routine lumbar punctures .


We included patients with acute lymphoblastic leukemia aged 3-21 years requiring at least two routine lumbar punctures .


Patients were randomly assigned to receive EMLA or placebo cream and the alternate treatment with the second procedure .


Patients , personnel and outcome assessors were blinded to allocation .


The primary outcome included three indirect measures of pain : total median propofol doses , patient movement and heart rate changes at the time of skin puncture in both treatment groups .


Twenty-six patients were enrolled and 25 were analyzed .


With EMLA cream , 4 mg/kg ( median ) of propofol was required ( 95 % CI 3.5-4 .4 ) .


With placebo , 4.9 mg/kg of propofol was needed ( 95 % CI 4.3-5 .6 ; P = 0.008 ) .


When EMLA cream was applied , 8 % of patients moved , whereas 84 % moved with placebo cream ( P < 0.0001 ) .


There was a lower average heart rate by seven beats in the EMLA treatment compared to placebo ( 95 % CI -2.3 -4.3 ; 4.1-12 .4 ; P = 0.009 ) .


There were no adverse events in either treatment group .


This study demonstrated that the combination of EMLA cream with propofol is beneficial .


Topical analgesics are at the discretion of the oncologist , allowing us to advocate for patients by providing safe and efficacious pain management for lumbar punctures .


We aimed to investigate effects of superoxide dismutase ( SOD ) - melon concentrate supplementation on psychological stress , physical and mental fatigue in healthy people .


A randomized , double-blind , placebo-controlled trial was performed on 61 people divided in two groups : active supplement ( n = 32 ) and placebo ( n = 29 ) for 12 weeks .


Volunteers were given one small hard capsule per day .


One capsule contained 10 mg of SOD-melon concentrate ( 140 U of SOD ) and starch for the active supplement and starch only for the placebo .


Stress and fatigue were evaluated using four psychometric scales : PSS-14 ; SF-36 ; Stroop tests and Prevost scale .


The supplementation with SOD-melon concentrate significantly decreased perceived stress , compared to placebo .


Moreover , quality of life was improved and physical and mental fatigue were reduced with SOD-melon concentrate supplementation .


SOD-melon concentrate supplementation appears to be an effective and natural way to reduce stress and fatigue .


trial approved by the ethical committee of Poitiers ( France ) , and the ClinicalTrials.gov Identifier is NCT01767922 .


No consensus exists for the best way to monitor and when to trigger delivery in mothers of babies with fetal growth restriction .


We aimed to assess whether changes in the fetal ductus venosus Doppler waveform ( DV ) could be used as indications for delivery instead of cardiotocography short-term variation ( STV ) .


In this prospective , European multicentre , unblinded , randomised study , we included women with singleton fetuses at 26-32 weeks of gestation who had very preterm fetal growth restriction ( ie , low abdominal circumference [ < 10th percentile ] and a high umbilical artery Doppler pulsatility index [ > 95th percentile ] ) .


We randomly allocated women 1:1:1 , with randomly sized blocks and stratified by participating centre and gestational age ( < 29 weeks vs 29 weeks ) , to three timing of delivery plans , which differed according to antenatal monitoring strategies : reduced cardiotocograph fetal heart rate STV ( CTG STV ) , early DV changes ( pulsatility index > 95th percentile ; DV p95 ) , or late DV changes ( A wave [ the deflection within the venous waveform signifying atrial contraction ] at or below baseline ; DV no A ) .


The primary outcome was survival without cerebral palsy or neurosensory impairment , or a Bayley III developmental score of less than 85 , at 2 years of age .


We assessed outcomes in surviving infants with known outcomes at 2 years .


We did an intention to treat study for all participants for whom we had data .


Safety outcomes were deaths in utero and neonatal deaths and were assessed in all randomly allocated women .


This study is registered with ISRCTN , number 56204499 .


Between Jan 1 , 2005 and Oct 1 , 2010 , 503 of 542 eligible women were randomly allocated to monitoring groups ( 166 to CTG STV , 167 to DV p95 , and 170 to DV no A ) .


The median gestational age at delivery was 307 weeks ( IQR 291-321 ) and mean birthweight was 1019 g ( SD 322 ) .


The proportion of infants surviving without neuroimpairment did not differ between the CTG STV ( 111 [ 77 % ] of 144 infants with known outcome ) , DV p95 ( 119 [ 84 % ] of 142 ) , and DV no A ( 133 [ 85 % ] of 157 ) groups ( ptrend = 009 ) .


12 fetuses ( 2 % ) died in utero and 27 ( 6 % ) neonatal deaths occurred .


Of survivors , more infants where women were randomly assigned to delivery according to late ductus changes ( 133 [ 95 % ] of 140 , 95 % , 95 % CI 90-98 ) were free of neuroimpairment when compared with those randomly assigned to CTG ( 111 [ 85 % ] of 131 , 95 % CI 78-90 ; p = 0.005 ) , but this was accompanied by a non-significant increase in perinatal and infant mortality .


Although the difference in the proportion of infants surviving without neuroimpairment was non-significant at the primary endpoint , timing of delivery based on the study protocol using late changes in the DV waveform might produce an improvement in developmental outcomes at 2 years of age .


ZonMw , The Netherlands and Dr Hans Ludwig Geisenhofer Foundation , Germany .


To compare corneal stromal and endothelial cells after photorefractive keratectomy with intraoperative mitomycin C in alcohol-assisted versus mechanical epithelial debridement using confocal microscopy .


This prospective randomized comparative study was performed on 88 eyes ( 44 patients ) with myopia up to -6.00 diopters .


The right eye of each patient was randomly assigned to either mechanical or alcohol-assisted groups , and the left eye was assigned to the alternate group .


Confocal microscopy was performed preoperatively and at 3 months postoperatively .


The main outcome measures were epithelial thickness ; number of keratocytes in the anterior , mid - , and posterior stroma ; and characteristics of the central corneal endothelial cells in terms of density , mean cell area , and polymegathism and hexagonality .


Three months after surgery , no statistically significant difference was noted between the study groups in terms of epithelial thickness .


We also found no statistically significant difference in central corneal endothelial cells regarding cell density , mean cell area , hexagonality , or polymegathism .


Compared with baseline values , the density of mid - and posterior stromal keratocytes showed no significant change in either group , whereas it decreased significantly in the anterior stroma in both groups 3 months after surgery .


We found that the adverse effects of photorefractive keratectomy with mitomycin C on central corneal endothelial cells were comparable between the mechanical and alcohol-assisted epithelial debridement groups and the significant decrease in postoperative keratocyte density in anterior stroma was comparable between the two groups .


The choice of their application could be left to the discretion of the ophthalmologist .


The transition from pediatric to nephrology care is not yet a standardized procedure .


The result is an increased risk of deteriorating transplant function , with the potential for premature transplant failure .


In phase I of this study , we shall evaluate the current patient transition situation in all existing German pediatric and nephrology departments ( n = 17 ) , including an evaluation of the views of physicians , nurses , and psychosocial support staff regarding transition .


Phase II will be a prospective , randomized study in which we compare current unstructured transition ( control group ) to structured transition ( intervention group ) .


The structured transition approach integrates the core elements of the Berliner TransitionsProgramm in combination with two facilitating smartphone apps .


The primary endpoint of this study will be therapy adherence , as reflected by group variation coefficients of immunosuppressive agent levels .


As a secondary outcome , we will compare patients ' self-reported quality of life , satisfaction of patients and their parents with each transition model , and how patient-centered healthcare components are utilized .


These secondary parameters will be assessed with established instruments or with instruments developed ( and pilot tested ) in phase I of the project .


The long-term goal of this work is to provide a model of structured transition from pediatric to adult care for adolescent nephrology patients , in order to improve transplant survival and patient wellbeing .


Identifier : Clinicaltrials.gov : ISRCTN22988897 , registered on 24 April 2014 ) .


To explore the clinical efficacy of radiotherapy combined with concurrent combination chemotherapy in the treatment of patients with advanced nasopharyngeal carcinoma ( NPC ) .


Two hundred patients with stage III/IV NPC were randomly allocated into the treatment group ( N = 100 ) and the control group ( N = 100 ) .


Patients in the control group received conventional fractionated radiotherapy , while patients in the treatment group received conventional fractionated radiotherapy combined with concurrent combination chemotherapy with cisplatin and 5-fluorouracil ( 5-FU ) .


Short-term efficacy , radiotherapy toxicity , shortand long-term survival were compared .


The short-term response rate of the treatment group was 96 % , which was significantly higher than that of the control group ( 87 % , p < 0.05 ) .


The local radiation toxicity of the treatment group was similar to that of the control group p > 0.05 ) , but the hematological and gastrointestinal toxicities were significantly higher in the treatment group p < 0.05 ) .


The 1 - , 3 - and 5-year overall survival rates were 87 , 80 , and 76 % , respectively , in the treatment group and 74 , 64 , and 51 % , respectively , in the control group , significantly favoring the treatment group p < 0.05 ) .


Radiotherapy with concurrent combination chemotherapy can improve the prognosis of patients with advanced NPC but at the cost of significant toxicity .


To determine the induction doses , then minimum infusion rates of alfaxalone for total intravenous anaesthesia ( TIVA ) , and subsequent , cardiopulmonary effects , recovery characteristics and alfaxalone plasma concentrations in cats undergoing ovariohysterectomy after premedication with butorphanol-acepromazine or butorphanol-medetomidine .


Prospective randomized blinded clinical study .


Twenty-eight healthy cats .


Cats undergoing ovariohysterectomy were assigned into two groups : together with butorphanol [ 0.2 mgkg ( -1 ) intramuscularly ( IM ) ] , group AA ( n = 14 ) received acepromazine ( 0.1 mgkg ( -1 ) IM ) and group MA ( n = 14 ) medetomidine ( 20gkg ( -1 ) IM ) .


Anaesthesia was induced with alfaxalone to effect [ 0.2 mgkg ( -1 ) intravenously ( IV ) every 20seconds ] , initially maintained with 8mgkg ( -1 ) hour ( -1 ) alfaxalone IV and infusion adjusted ( 0.5 mg kg ( -1 ) hour ( -1 ) ) every five minutes according to alterations in heart rate ( HR ) , respiratory rate ( fR ) , Doppler blood pressure ( DBP ) and presence of palpebral reflex .


Additional alfaxalone boli were administered IV if cats moved/swallowed ( 0.5 mgkg ( -1 ) ) or if fR > 40 breaths minute ( -1 ) ( 0.25 mgkg ( -1 ) ) .


Venous blood samples were obtained to determine plasma alfaxalone concentrations .


Meloxicam ( 0.2 mgkg ( -1 ) IV ) was administered postoperatively .


Data were analysed using linear mixed models , Chi-squared , Fishers exact and t-tests .


Alfaxalone anaesthesia induction dose ( meanSD ) , was lower in group MA ( 1.870.5 ; group AA : 2.570.41 mgkg ( -1 ) ) .


No cats became apnoeic .


Intraoperative bolus requirements and TIVA rates ( group AA : 11.621.37 , group MA : 10.760.96 mgkg ( -1 ) hour ( -1 ) ) did not differ significantly between groups .


Plasma concentrations ranged between 0.69 and 10.76 gmL ( -1 ) .


In group MA , fR , end-tidal carbon dioxide , temperature and DBP were significantly higher and HR lower .


Alfaxalone TIVA in cats after medetomidine or acepromazine sedation provided suitable anaesthesia with no need for ventilatory support .


After these premedications , the authors recommend initial alfaxalone TIVA rates of 10mg kg ( -1 ) hour ( -1 ) .


Zoledronic acid decreases the risk for skeletal-related events ( SREs ) in men with castration-resistant prostate cancer and bone metastases but its role earlier in the natural history of the disease is unknown .


This phase III study evaluated the efficacy and safety of earlier treatment with zoledronic acid in men with castration-sensitive metastatic prostate cancer .


Men with castration-sensitive prostate cancer and bone metastases whose androgen-deprivation therapy was initiated within 6 months of study entry were randomly assigned in a blinded 1:1 ratio to receive zoledronic acid ( 4 mg intravenously every 4 weeks ) or a placebo .


After their disease progressed to castration-resistant status , all patients received open-label treatment with zoledronic acid .


The primary end point was time to first SRE , defined as radiation to bone , clinical fracture , spinal cord compression , surgery to bone , or death as a result of prostate cancer .


Target accrual was 680 patients .


Primary analysis was planned after 470 SREs .


The study was discontinued prematurely ( 645 patients ; 299 SREs ) after the corporate supporter withdrew study drug supply .


Early zoledronic acid was not associated with increased time to first SRE .


The median time to first SRE was 31.9 months in the zoledronic acid group ( 95 % CI , 24.2 to 40.3 ) and 29.8 months in the placebo group ( 95 % CI , 25.3 to 37.2 ; hazard ratio , 0.97 ; 95 % CI , 0 to 1.17 ; one-sided stratified log-rank P = .39 ) .


Overall survival was similar between the groups ( hazard ratio , 0.88 ; 95 % CI , 0.70 to 1.12 ; P = .29 ) .


Rates of adverse events were similar between the groups .


In men with castration-sensitive prostate cancer and bone metastases , early treatment with zoledronic acid was not associated with lower risk for SREs .


About 45 % of all pregnant women suffer low back pain and/or pelvic girdle pain ( LBPGP ) .


This study seeks to evaluate the effect of auricular acupuncture on LBPGP compared with placebo auricular acupuncture and with standard obstetric care in the field of primary health care .


This study will be a four-parallel-arm , multicentre , randomised , placebo-controlled trial .


A total of 212 pregnant women ( 24 to 36weeks ' gestation ) , aged at least 17years , with LBPGP , will be randomly assigned to the verum auricular acupuncture plus standard obstetric care group ( VAAc ) , to the non-specific auricular acupuncture plus standard obstetric care group ( NSAAc ) , to the non-specific placebo auricular acupuncture plus standard obstetric care group ( PAAc ) , or the standard obstetric care group ( SOC ) .


The VAAc , NSAAc , and PAAc groups will receive treatment at three auricular acupuncture points ( specific points for the VAAc group or non-specific ones for the NSAAc and PAAc groups ) , once a week for 2weeks ; the SOC group will receive only standard obstetric care during the same period .


The primary outcome will be the reduction in pain intensity , according to the visual analogue scale ( iVAS ) , at 2weeks after the start of treatment .


The secondary outcomes will be functional status with respect to LBPGP ( according to the Roland-Morris disability questionnaire ) , health-related quality of life ( SF12 ) at 2weeks after the start of treatment , and iVAS at 12 and 48weeks postpartum .


This trial will implement a high-quality methodology and may provide evidence for the efficacy , safety , and specificity of auricular acupuncture as a treatment for pregnant women with LBPGP .


Current Controlled Trials ISRCTN41033073 ( date 20/03/2014 ) .


To explore safe , effective , simple and easy non-drug treatments for grade 1 essential hypertension .


According to TCM syndrome differentiation , 126 cases of grade 1 essential hypertension were classified into 4 types : liver-fire hyperactivity syndrome , yin-deficiency and yang-hyperactivity syndrome , excessive phlegm-dampness syndrome , yin-yang deficiency syndrome , and then the patients were randomly divided into a photoelectric combined with musical treatment group ( group A ) , an acupuncture group ( group B ) and a placebo group ( group C ) .


The acupoints were selected according to TCM syndrome differentiation in group A and group B , and multi-mode audio frequency pulse photoelectric therapeutic apparatus and acupuncture were used in the two groups respectively , once daily .


Taichong ( LR 3 ) and Quchi ( LI 11 ) were selected in liver-fire hyperactivity syndrome , Taixi ( KI 3 ) and Sanyinjiao ( SP 6 ) were selected yi yin-deficiency and yang-hyperactivity syndrome , Zusanli ( ST 36 ) and Fenglong ( ST 40 ) were selected in excessive phlegm-dampness syndrome , while Taixi ( KI 3 ) and Guanyuan ( CV 4 ) were selected yi yirryang deficiency syndrome .


The group C was treated with oral administration of starch tablet ( 25 mg ) , one tablet each time , three times everyday .


Ten days were considered as one course , totally three courses were required in the three groups .


The blood pressure and scores of TCM syndromes before and after treatment were compared among the three groups .


The blood pressure decreased significantly after treatment in group A and group B ( all P < 0.01 ) , and the decrease in systolic blood pressure was more significant in group A ( P < 0.05 ) .


The total effective rate was 90.5 / ( 38/42 ) in group A , which was superior to 71.4 ( 30/42 , P < 0.05 ) in group B and 19.1 % ( 18/34 , P < 0.01 ) in group C.


The scores of TCM syndromes were both improved in group A and group B , but without significant difference between the two groups ( P > 0.05 ) .


The clinical effect of multi-mode audio frequency pulse photoelectric therapeutic apparatus for treatment of grade 1 essential hypertension is reliable .


Meanwhile , it has the advantages of a non-invasive and simple operation .


To evaluate the efficacy of adding folic acid to oral iron supplementation in postpartum women with anemia .


A randomized controlled trial was conducted in the Netherlands between April 8 , 2008 , and August 31 , 2010 .


A total of 112 postpartum women with anemia ( hemoglobin < 10.5 g/dL ) were randomly allocated to receive 600 mg/day ferrous fumarate plus 1mg/day folic acid ( FFFA group ) or 600/day ferrous fumarate alone ( FF group ) for 4 weeks .


Primary outcome measures were hemoglobin and health status .


Secondary outcome measures were fatigue , compliance , and adverse reactions .


No between-group differences were observed in hemoglobin and health status after treatment , and no differences were found in fatigue scores .


Approximately 75 % of all women reported having at least one symptom resulting from ferrous fumarate use .


Constipation caused by ferrous fumarate was significantly associated with non-compliance ( P = 0.014 ) .


The addition of folic acid to iron supplementation is not beneficial in women with postpartum anemia , as it has no effect on hematologic or health status parameters .


CCMO website NL21797 .028.08 and Netherlands Trial Register NTR2232 .


Data show that many research subjects have difficulty understanding study information using traditional paper consent documents .


This study , therefore , was designed to evaluate the effect of an interactive multimedia program on improving parents ' and children 's understanding of clinical trial concepts and participation .


Parents ( n = 148 ) and children ( n = 135 ) were each randomised to receive information regarding clinical trials using either a traditional paper format ( TF ) or an interactive iPad program ( IP ) with inline exercises .


Participants ' understanding of the information was assessed using semistructured interviews prior to ( pretest ) and after ( post-test ) receiving the information .


Participants also completed a short survey to assess their perceptions of information delivery and satisfaction with the process .


Regardless of the mode of information delivery , all participants demonstrated improved pretest to post-test understanding .


While there were no statistical differences in parents ' post-test understanding between the TF and IP groups , children in the IP group had significantly greater post-test understanding compared with children in the TF group ( 11.65 ( 4.1 ) vs 8.85 ( 4.1 ) ( 2.8 , 1.4 , 4.2 ) 0-18 scale where 18 = complete understanding ) .


Furthermore , the IP was found to be significantly ` easier to follow ' and ` more effective ' in presenting information compared with the TF .


Results demonstrated the importance of providing information regarding clinical trial concepts to parents and children .


Importantly , the ability of interactive multimedia to improve understanding of clinical trial concepts and satisfaction with information delivery , particularly among children , supports this approach as a novel and effective vehicle for enhancing the informed consent process .


Many cancer patients report unmet rehabilitation needs .


Rehabilitation may include activities of daily living ( ADL ) tasks , but little is known about how cancer patients perform these tasks and how they prioritize their daily activities .


Hence , this study aims to identify and characterize ADL task performance problems among a group of adult disabled hospitalized cancer patients using interview and questionnaire data .


Cross-sectional study on prevalence of ADL task performance problems experienced by disabled hospitalized cancer patients using the Activities of Daily Living Questionnaire ( ADL-Q ) ( n = 118 ) and the Canadian Occupational Performance Measure ( COPM ) ( n = 55 ) .


All 118 patients reported problems with ADL task performance .


Based on the ADL-Q patients reported more problems within instrumental ( I - ) ADL than personal ( P - ) ADL .


In both I-ADL and P-ADL the results differed between women and men .


There was significant overlap between problems identified using the COPM and the ADL-Q instruments .


RESULTS from the COPM showed that 65 % of problems were related to self-care , 25 % to leisure , and 19 % to productivity .


Using both instruments identified more ADL problems than when using only one of the instruments .


Adult hospitalized disabled cancer patients experience a high degree and variation in difficulties performing ADL , illustrating the need for a comprehensively planned assessment of problems and needs .


Long-term follow-up study is required for verifying whether the clinical outcomes of kyphoplasty and vertebroplasty are altered .


The authors ' findings showed only subtle differences between these operations within a 5-year period .


However , they still suggest the use of vertebroplasty over kyphoplasty in view of the treatment costs .


In their previous study , the authors performed a short-term prospective comparison between vertebroplasty and kyphoplasty .


Vertebroplasty was recommended instead of kyphoplasty for the treatment of vertebral compression fractures ( VCFs ) because of the subtle differences between this procedure and kyphoplasty and the treatment costs .


To determine whether these clinical outcomes persist in the long term , they continued to observe the patients from their short-term study over a longer-term period .


METHODS : One hundred cases of VCF were assigned randomly to either the kyphoplasty or the vertebroplasty group .


In cement augmentation , the authors used polymethylmethacrylate as bone filler .


Pain was assessed by using a visual analog scale ( VAS ) .


For each patient , vertebral body height and wedge angle were measured from reconstructed CT images .


The duration of the follow-up period was 5 years .


Vertebral body height , kyphotic wedge angle , and VAS score were not evidently altered .


Eight patients in the kyphoplasty group had an adjacent fracture after the procedure , whereas 7 patients in the vertebroplasty group had an adjacent fracture after the procedure .


These adjacent fractures occurred within 1 year of surgery in both treatment groups except in 1 kyphoplasty-treated patient in whom the adjacent fracture was noted 16 months after treatment .


Three patients in the vertebroplasty group had a nonadjacent fracture , and 4 patients in the kyphoplasty group had a nonadjacent fracture .


The link between angular correction and the occurrence of adjacent fracture was statistically significant in the vertebroplasty group .


Excessive angular correction is a critical concern in the risk of adjacent fracture after vertebroplasty .


Given the subtle differences between vertebroplasty and kyphoplasty observed over the course of 5 years , vertebroplasty remains the preferred option in view of the costs .


To determine the rate of cervical intraepithelial neoplasia grade 2 ( CIN2 + ) in women with low grade cervical cytology and a normal colposcopy examination over 3 years of follow-up .


Cohort study within a randomised controlled trial .


NHS Cervical Screening Programmes in Grampian , Tayside and Nottingham .


Eight hundred and eighty-four women aged 20-59 years with borderline nuclear abnormalities ( BNA ) or mild dyskaryosis with a normal and adequate colposcopy examination .


Samples at baseline were tested for 14 high-risk ( Hr ) types using GP5 +6 + methodology and for HPV 16 and 18 using type-specific primers .


Women were followed up post-colposcopy by cervical cytology at 6-month intervals in primary care .


After 3 years , women were invited for an exit colposcopy examination and underwent LLETZ if any colposcopic abnormality was identified .


Absolute and relative risks of CIN2 + during follow-up and/or at exit colposcopy .


The median age was 36 years .


The absolute risk of developing CIN2 + within 3 years was 1.86 per 100 woman years and for CIN3 + , 0.64 per 100 woman years .


One microinvasive cancer was identified .


The relative risk ( RR ) was highest for women with initial mild dyskaryosis who were HrHPV-positive ( RR 5.86 , 95 % confidence interval 2.53-13 .56 ) compared with women with BNA who were HrHPV-negative .


For women with low grade cervical cytology , the risk of a high grade CIN within 3 years of a normal colposcopy examination is low .


Women can be reassured that , even with a positive HPV test , the risk of developing CIN2 or worse is sufficiently low to return to the routine 3-year recall .


Constipation is a very common symptom in the general population .


One way of non-pharmacological treatment of constipation is through the addition of probiotics to food .


The aim of this study was to evaluate de effect of the consumption of a fresh cheese , enriched with Bifidobacterium lactis Bi-07 on the symptoms of constipated women .


A randomized controlled trial , carried out in the Basic Health Units of Guapor 's City - RS/Brazil , between January and May 2012 , with 30 constipated women .


The patients were randomized into two groups whom received , for 30 days , 30 g of fresh cheese enriched with Bifidobacterium lactis Bi-07 ( n = 15 ) or regular fresh cheese ( n = 15 ) .


Constipation symptoms were evaluated according to ROMA III Consensus , before and after the nutritional intervention .


Also , data of clinical and anthropometric characteristics of the individuals were collected .


Accepted level of significance 5 % ( P0 ,05 ) .


The medium age of the studied population was 37,514,4 years in the intervention group and 40,812,8 years in the control group .


After 30 days we observed that the ingestion of fresh cheese enriched with Bifidobacterium lactis Bi-07 promoted benefic effects on the symptoms of strength to evacuate .


The consumption of 30g/day of a fresh cheese enriched with Bifidobacterium lactis Bi-07 has beneficial effects on constipation symptoms .


There is a need to improve participation in colorectal cancer screening .


Our objective was to assess the impact of a signature from the patient 's general practitioner on a letter inviting patients to participate in a colorectal cancer screening .


We conducted a cluster randomized controlled trial with 57 general practitioners established in Paris for more than 5 years , randomized to intervention or usual-care arms .


There were 3422 patients included , ages 50-74 years , from general practitioner patient files , and eligible for an invitation letter or a reminder letter to participate in the national population-based screening program .


In the intervention arm , patients received a standard letter signed by their general practitioner inviting them to visit the general practitioner 's office for a fecal occult blood test if they were eligible .


Control patients received the standard invitation letter or the standard reminder .


All letters were sent by the district screening organization .


The main outcome was the proportion of patients who took the fecal occult blood test within 6 months after the invitation .


Among patients eligible for the study , 508 ( 14.8 % ) took a fecal occult blood test after being invited ; 285 ( 15 % ; 95 % confidence interval [ CI ] , 13.5-16 .7 ) in the intervention group and 223 ( 14.6 % ; 95 % CI , 12.9-16 .5 ) in the control group , with no statistical difference between the 2 groups ( odds ratio 1.04 ; 95 % CI , 0.83-1 .31 ; P = .731 ) .


The addition of a general practitioner 's signature to a standard letter inviting patients to take a fecal occult blood test had no impact on the frequency of patients taking the fecal occult blood test in the Paris program of colorectal cancer screening .


To observe the therapeutic effect of acupuncture and moxibustion interventions in the treatment of chronic fatigue syndrome ( CFS ) .


A total of 133 CFS patients were randomized into acupuncture group ( 47 cases ) , warm-needling group ( 44 cases ) and non-acupoint group ( 42 cases ) .


Manual acupuncture ( MA ) stimulation was applied to Baihui ( GV 20 ) , Danzhong ( CV 17 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , bilateral Zusanli ( ST 36 ) , Hegu ( LI 4 ) , Taichong ( LR 3 ) and Sanyinjiao ( SP 6 ) for patients in the acupuncture group .


For patients in the warm-needling group , moxa-heated needle was applied to Baihui ( GV 20 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) and bilateral Zusanli ( ST 36 ) .


Non-acupoints were located about 1-2 cm beside the Baihui ( GV 20 ) , Danzhong ( CV 17 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) , Zusanli ( ST 36 ) , Taichong ( LR 3 ) , Sanyinjiao ( SP 6 ) and Hegu ( LI 4 ) .


The treatment was given once daily for 20 days .


The Chalder Fatigue Scale ( 14-item fatigue scale ) was adopted to evaluate the changes of CFS before and after the treatment .


In comparison with pre-treatment , the scores of Chalder Fatigue Scale including physical and mental fatigue and total score were significantly decreased in both acupuncture and warm-needling groups ( P < 0.05 , P < 0.01 ) , but not in the non-acupoint group ( P > 0.05 ) except physical score ( P < 0.05 ) .


The physical , mental and total scores of the acupuncture and warm-needling groups were significantly lower than those of the non-acupoint group ( P < 0.05 , P < 0.01 ) , while the physical and total scores of the warm-needling group were markedly lower than those of the acupuncture group ( P < 0.05 ) .


After the treatment , the CFS patients ' satisfactory rates of the acupuncture , warm-needling and non-acupoint groups were 36.2 % ( 17/47 ) , 72.7 % ( 32/44 ) and 35.7 % ( 15/42 ) , respectively .


Both MA and warm-needling interventions have a good therapeutic effect in the treatment of CFS patients , while the latter is obviously better .


To test the effectiveness of a programme aimed at reducing the risky use of alcohol and alcohol-related HIV risk and increase help-seeking behaviour among a sample of municipal employees in the Western Cape Province , South Africa .


A clustered randomised controlled trial was conducted in 2011-2012 among 325 employees .


The eight hour intervention , Team Awareness ( TA ) , addressing behavioural risk among employees was administered to 168 employees in the intervention arm and the 157 employees in the control arm who received a one-hour wellness talk .


The results show that TA had the greatest impact on risky drinking practices and hangover effects .


There was a significant group time interaction ( F ( 1 , 117 ) = 25.16 , p < 0.0001 ) with participants in the intervention condition reducing number of days on which they engaged in binge drinking .


There was also a significant time effect with participants in the intervention condition reducing the likelihood of going to work with a hangover ( F ( 1,117 ) = 4.10 , p = 0.045 ) .


No reduction in HIV-related risk behaviours were found .


This intervention study was able to demonstrate a modest but significant reduction in risky drinking practices and hangover effects .


This provides encouraging evidence for the effectiveness of interventions that address risky use of alcohol among employed persons , further providing a launch pad for strengthening and replicating future RCT studies on workplace prevention , especially in developing country settings .


Pan-African Control Trial Registry ( 201301000458308 ) .


Insufficient sleep is associated with increased cardiometabolic risk .


Alterations in hypothalamic-pituitary-adrenal axis may underlie this link .


Our objective was to examine the impact of restricted sleep on daytime profiles of ACTH and cortisol concentrations .


Thirteen subjects participated in 2 laboratory sessions ( 2 nights of 10 hours in bed versus 2 nights of 4 hours in bed ) in a randomized crossover design .


Sleep was polygraphically recorded .


After the second night of each session , blood was sampled at 20-minute intervals from 9:00 am to midnight to measure ACTH and total cortisol .


Saliva was collected every 20 minutes from 2:00 pm to midnight to measure free cortisol .


Perceived stress , hunger , and appetite were assessed at hourly intervals by validated scales .


Sleep restriction was associated with a 19 % increase in overall ACTH levels ( P < .03 ) that was correlated with the individual amount of sleep loss ( rSp = 0.63 , P < .02 ) .


Overall total cortisol levels were also elevated ( +21 % ; P = .10 ) .


Pulse frequency was unchanged for both ACTH and cortisol .


Morning levels of ACTH were higher after sleep restriction ( P < .04 ) without concomitant elevation of cortisol .


In contrast , evening ACTH levels were unchanged while total and free cortisol increased by , respectively , 30 % ( P < .03 ) and 200 % ( P < .04 ) .


Thus , the amplitude of the circadian cortisol decline was dampened by sleep restriction ( -21 % ; P < .05 ) .


Sleep restriction was not associated with higher perceived stress but resulted in an increase in appetite that was correlated with the increase in total cortisol .


The impact of sleep loss on hypothalamic-pituitary-adrenal activity is dependent on time of day .


Insufficient sleep dampens the circadian rhythm of cortisol , a major internal synchronizer of central and peripheral clocks .


Inflammation and coagulation biomarkers interleukin ( IL ) -6 and D-dimer are predictive of all-cause mortality in chronic HIV-1 infection ; however , their predictive value in individuals with recent infection has not been described .


SPARTAC was a randomized controlled trial comparing three strategies of intervention in primary HIV-1 infection [ no therapy , 12-week or 48-week antiretroviral therapy ( ART ) ] .


Plasma IL-6 and D-dimer were measured in 200 participants from sites in Australia , Brazil , UK and Italy .


We evaluated age , sex/HIV risk group , time since HIV-1 seroconversion , baseline HIV-RNA , CD4 cell count and BMI as possible predictors of IL-6 and D-dimer levels at seroconversion using multivariable linear regression .


For participants remaining ART-naive , we evaluated whether baseline IL-6 and D-dimer levels independently predicted time to reaching CD4 cell count less than 350 cells/l or initiating ART using multivariable Cox proportional hazards models .


Median ( interquartile range , IQR ) baseline IL-6 and D-dimer levels were 1.45 ( 0.88-2 .41 ) pg/ml and 0.34 ( 0.20-0 .50 ) g/l , respectively .


Higher levels were associated with older age ( P = 0.008 and 0.004 , respectively ) .


Higher D-dimer levels were associated with higher HIV-RNA ( P < 0.001 ) .


For the 73 participants not initiating ART ( median follow-up 225 weeks ) , of whom 48 reached the primary endpoint , higher baseline IL-6 , but not D-dimer , was independently associated with a shorter time to primary endpoint [ hazard ratio = 1.38 per additional pg/ml , 95 % confidence interval ( CI ) 1.09-1 .75 ; P = 0.007 ] .


Other baseline predictors were older age ( P = 0.030 ) , higher RNA ( P = 0.033 ) and lower CD4 cell count ( P < 0.001 ) .


IL-6 levels at time of HIV-1 seroconversion independently predict HIV-1 disease progression in patients with primary HIV-1 infection .


The incidence of propofol injection pain is high in children , but no methods have been found to suppress it completely .


This study intends to evaluate the efficacy of dexmedetomidine-midazolam in preventing propofol injection pain in children .


One-hundred ASA I patients , aged 3-12 years , weighing 15-53 kg , undergoing elective surgery were randomized into two groups of 50 each , using computer-generated random numbers .


Normal saline 0.15 ml/kg in Group C or dexmedetomidine 0.6 g/kg in Group D was infused IV over 10 min .


Then midazolam 0.06 mg/kg was administered immediately ; 2 min after aforementioned treatments in each group , all patients received propofol 2 mg/kg ( propofol was mixed with lidocaine 1 mg/ml in Group C ) at an average rate of 0.2 ml per 1 s. Another anesthesiologist , blind to the pretreatment , recorded the occurrence of injection pain using a four-graded pain scale : 1 = no pain ( no reaction to injection ) , 2 = slight pain ( minor verbal/facial response or motor reaction to injection ) , 3 = moderate pain ( clear verbal/facial response or motor reaction to injection ) and 4 = severe pain ( the patient both complained of pain and withdrew the arm ) .


Forty ( 80 % ) patients in Group C ( control ) had injection pain ; however , none of patients in Group D had any injection pain .


The total incidence of profol-induced pain in Group C was significantly higher ( P < 0.01 ) .


There were no instances of bradycardia or low blood pressure with either treatment in this study .


Pretreatment with dexmedetomidine 0.6 g/kg , then midazolam 0.06 mg/kg could suppress propofol injection pain in children .


To compare the antioxidant and inflammatory cytokine activities in tears of patients with dry eye syndrome treated with preservative-free versus preserved eye drops .


A total of 100 patients with moderate to severe dry eye syndrome were randomly divided into two groups .


Fifty patients ( group 1 ) were treated four times with preservative-free 0.1 % sodium hyaluronate and 0.1 % fluorometholone eye drops in the first month and with preservative-free 0.1 % sodium hyaluronate and 0.05 % cyclosporine eye drops in the second and third months .


Another 50 patients ( group 2 ) were treated with preserved eye drops on the same schedule .


Ocular Surface Disease Index , corneal fluorescein staining , Schirmer I test , tear film breakup time , impression cytology , and antioxidant and inflammatory cytokine activities in tears were evaluated .


Treatment with preservative-free eye drops led to significant improvements in symptoms , tear film breakup time , Schirmer I score , and impression cytologic findings compared to treatment with preserved eye drops ( P < 0.05 ) in patients with dry eye syndrome .


There was a statistically significant decrease in the IL-1 , IL-6 , IL-12 , and TNF - concentrations and a statistically significant increase in the catalase , peroxiredoxin 2 , superoxide dismutase 2 ( SOD 2 ) , and thioredoxin mean fluorescence intensity ( MFI ) of tears in the preservative-free group at 1 , 2 , and 3 months compared to initial values , respectively ( P < 0.05 ) .


Treatment with preservative-free eye drops is effective against the dry eye syndrome .


Preservative-free eye drops seem to be more effective than preserved eye drops in decreasing ocular inflammation and in increasing antioxidant contents in tears of patients with dry eye syndrome .


The purpose of our study was to evaluate and compare two methods of service delivery ( web-based and telehealth-based ) for chronic insomnia with regard to patient preference , clinical effectiveness , and patient satisfaction .


Our study was a randomized controlled trial with manualized telehealth - and web-based delivery conditions ( nonblinded ) .


The sample comprised 73 adults with chronic insomnia .


Participants received web-based delivery from their homes or telehealth-based delivery from a nearby clinic .


Both interventions consisted of identical psychoeducation , sleep hygiene and stimulus control instruction , sleep restriction treatment , relaxation training , cognitive therapy , mindfulness meditation , and medication-tapering assistance .


Using a linear mixed model analysis , results showed that both delivery methods produced equivalent changes in insomnia severity , with large effect sizes .


Attendance patterns favored telehealth , whereas homework adherence and preference data favored web-based delivery .


Web - and telehealth-based delivery are both helpful in treating chronic insomnia in rural-dwelling adults .


Metabolic syndrome ( MetS ) comprises a spectrum of clinical phenotypes in which dyslipidemia , dysglycemia and hypertension are clustered and where all share a high level of oxidative stress and an increased risk of cardiovascular disease .


This study examines the effect of a nutritional supplement combining red yeast rice and olive fruit extract on the lipid profile and on oxidative stress in a population of patients with MetS .


In a double blind placebo controlled randomized trial , 50 persons with MetS , as defined by the ATPIII criteria , received the study product or placebo for 8 weeks .


The study product contained 10.82 mg of monacolins and 9,32 mg of hydroxytyrosol per capsule , and is commercialized as Cholesfytol plus .


The primary outcome measure was the difference in LDL reduction between intervention and control groups .


Furthermore , differences in changes of CH , HDL , ApoA1 , ApoB , HbA1c and oxLDL were measured , as well as side-effects , CK elevation , changes in clinical parameters and in cardiovascular risk .


In the intervention group , LDL cholesterol was lowered by 24 % whereas it increased by 1 % in the control group ( p < 0.001 ) .


Other effects observed were a change in total cholesterol ( -17 % in the intervention group vs +2 % in the control group , p < 0.001 ) , apolipoprotein B ( -15 % vs +6 % , p < 0.001 ) , and TG ( -9 % vs + 16 % , p = 0.02 ) .


Oxidized LDL decreased by 20 % vs an increase of 5 % in the control group ( p < 0.001 ) .


Systolic and diastolic arterial blood pressure decreased significantly by 10 mmHg ( vs 0 % in the control group , p = 0.001 ) and 7 mmHg ( vs 0 % in the control group , p = 0.05 ) respectively .


One person in the intervention group , who suffered from Segawa 's syndrome , dropped out because of severe muscle ache .


The combination of active products in this study may be an alternative approach to statins in people who do not need , or can not or do not want to be treated with chemical statins .


Side effects , effects on oxidative stress and on glucose metabolism need to be examined more thoroughly .


Clinicaltrials.gov NCT02065180 ( February 2014 ) .


Neurobehavioral functioning is widely recognized as being an important consideration in lung transplant candidates , but little is known about whether these factors are related to clinical outcomes .


The present study examined the relationship of neurobehavioral functioning , including measures of executive function and memory , depression , and anxiety , to long-term survival among lung transplant recipients .


The sample was drawn from 201 patients who underwent transplantation at Duke University and Washington University who participated in a dual-site clinical trial investigating medical and psychosocial outcomes in transplant candidates with end-stage lung disease .


All patients completed the Beck Depression Inventory-II ( BDI-II ) and Spielberger State-Trait Anxiety Inventory at baseline and again after 12 weeks , while a subset of 86 patients from Duke University also completed neurocognitive testing .


Patients were followed for survival up to 12 years after completing baseline assessments .


One hundred eleven patients died over a mean follow-up of 10.8 years ( SD = 0.8 ) .


Baseline depression , anxiety , and neurocognitive function were examined as predictors of posttransplant survival , controlling for age , 6-min walk distance , FEV , and native disease ; education and cardiovascular risk factors were also included in the model for neurocognition .


Lower executive function ( hazard ratio [ HR ] = 1.09 , P = .012 ) and memory performance ( HR = 1.11 , P = .030 ) were independently associated with greater mortality following lung transplant .


Although pretransplant depression and anxiety were not predictive of mortality , patients who scored > 13 on the BDI-II at baseline and after 3 months pretransplant had greater mortality ( HR = 1.85 [ 95 % CI , 1.04 , 3.28 ] , P = .036 ) .


Neurobehavioral functioning , including persistently elevated depressive symptoms and lower neurocognitive performance , was associated with reduced survival after lung transplantation .


ClinicalTrials.gov ; No. : NCT00113139 ; URL : www.clinicaltrials.gov .


To compare measures of dry mouth following extended use of an alcohol-based mouthrinse ( LISTERINE Antiseptic [ LA ] ) and a non-alcohol-based mouthrinse ( Crest Pro-Health Rinse [ CPH ] ) on healthy adults with `` normal '' salivary flow .


This single-site , randomized , observer-blinded , parallel study compared unstimulated whole salivary flow and perceived dryness following daily use at weeks 4 and 12 versus baseline .


Noninferiority , between-treatment flow comparisons ( 0.15 mL/min margin ) , and between-treatment comparisons of the mean Bluestone Mouthfeel Questionnaire ( BMQ ) visual analog scale scores were made using analysis of covariance .


Measures of dry mouth were comparable between mouthrinses , as demonstrated by both noninferiority of LA versus CPH flow ( P < .001 ) and no significant differences between groups in the BMQ measures at 4 or 12weeks .


Extended use of an alcohol-based mouthrinse is no more likely to cause reduction in salivary flow or perceived dryness in individuals with normal salivary flow compared with a non-alcohol-based mouthrinse ( CPH ) .


To investigate the relationship between optic nerve sheath diameter ( ONSD ) and retrobulbar blood flow velocities , as measured by color Doppler imaging ( CDI ) in glaucoma patients .


We performed a prospective , randomized , observer-masked study involving a total of 197 subjects .


Once enrolled , they were divided by three groups : healthy controls ( n = 51 ) , normal-tension glaucoma patients ( NTG , n = 58 ) , and primary , open-angle glaucoma patients ( POAG , n = 88 ) .


All subjects underwent a general ophthalmological examination , an ultrasound-based assessment of the ONSD , and a hemodynamic study of the retrobulbar vascularization using CDI .


Non-parametric tests , chi-square contingency tables , and the Deming correlations were used to explore differences and correlations between variables in the diagnostic groups .


ONSD was not different between experimental groups ( p = 0.28 ) .


ONSD correlated positively with the pulsatility index of the ophthalmic artery in healthy individuals ( p = 0.007 ) , but not in glaucoma patients ( NTG : p = 0.41 ; POAG : p = 0.22 ) .


In NTG patients , higher ONSD values were associated with lower end-diastolic and mean flow velocities in the short ciliary arteries ( p = 0.005 in both correlations ) .


No such correlation was found in healthy nor POAG groups ( p range between 0.15 to 0.96 ) .


ONSD was not associated with any CDI-related variable of the central retinal artery in any cohort .


Venous outflow velocities were not associated with ONSD in any of the three groups .


ONSD is negatively correlated with retrobulbar blood flow velocities in glaucoma patients , but not in healthy controls .


The objective of this study was to compare the efficacy and safety of dexamethasone and methylprednisolone for pulse therapy of rheumatoid arthritis flare-up .


This randomized double-blind controlled study was performed in the Emam Reza Educational Hospital of Tabriz University of Medical Sciences , Tabriz , Iran .


Thirty rheumatoid arthritis patients who had severely active disease were recruited to the dexamethasone and methylprednisolone pulse groups .


Disease activity of all the patients was measured by the Disease Activity Score in 28 joints ( DAS28 ) at baseline , and days 4 and 30 .


The differences in the DAS28 at days 4 and 30 , and the number of patients whose DAS28 obtained less than 3.2 and 2.6 in the dexamethasone and methylprednisolone groups were non-significant .


There was not any significant difference between the adverse effects of the treatments in the two groups .


The results of the study suggest that dexamethasone pulse therapy is a safe and effective treatment for severe rheumatoid arthritis flare-up .


Both supervised exercise ( SE ) and stenting ( ST ) improve functional status , symptoms , and quality of life compared with optimal medical care ( OMC ) in patients with claudication .


The relative cost-effectiveness of these strategies is not well defined .


The Claudication : Exercise Versus Endoluminal Revascularization ( CLEVER ) study randomized patients with claudication due to aortoiliac stenosis to a 6-month SE program , to ST , or to OMC .


Participants who completed 6-month follow-up ( n = 98 ) were included in a health economic analysis through 18 months .


Costs were assessed using resource-based methods and hospital billing data .


Quality-adjusted life-years were estimated using the EQ-5D .


Markov modeling based on the in-trial results was used to explore the impact of assumptions about the longer term durability of observed differences in quality of life .


Through 18 months , mean healthcare costs were $ 5178 , $ 9804 , and $ 14 590 per patient for OMC , SE , and ST , respectively .


Measured quality-adjusted life-years through 18 months were 1.04 , 1.16 , and 1.20 .


In our base case analysis , which assumed that observed differences in quality of life would dissipate after 5 years , the incremental cost-effectiveness ratios were $ 24 070 per quality-adjusted life-year gained for SE versus OMC , $ 41 376 for ST versus OMC , and $ 122 600 for ST versus SE .


If the treatment effect of ST was assumed to be more durable than that of SE , the incremental cost-effectiveness ratio for ST versus SE became more favorable .


Both SE and ST are economically attractive by US standards relative to OMC for the treatment of claudication in patients with aortoiliac disease .


ST is more expensive than SE , with uncertain incremental benefit .


www.clinicaltrials.gov , Unique identifier : NCT00132743 .


Vitiligo can be associated with high levels of distress , yet there are currently no self-help interventions available .


To describe the initial development of a psychosocial self-help intervention designed to reduce social anxiety associated with vitiligo .


Also to examine whether including a planning exercise , aimed at increasing use of the intervention ( termed implementation intentions ) , has the potential to achieve a clinically significant reduction in distress .


Participants ( n = 75 ) were randomized to one of three groups : cognitive behavioural self-help ( CBSH ) , CBSH augmented with implementation intentions ( CBSH + ) , or no intervention .


Participants were assessed at baseline and after 8weeks on measures of social anxiety , anxiety and depression , and appearance-related concern .


The two intervention groups also completed a questionnaire evaluating their use of , and satisfaction with , the intervention .


High levels of social anxiety and concern over appearance were reported .


Twenty-four per cent of participants in the CBSH + group experienced clinically significant change on the measure of social anxiety compared with 8 % in the CBSH group and 0 % in the control group .


In addition , 58 % of the control group deteriorated during the study period .


There were no significant differences between the conditions on the other outcome measures .


Participants reported that the self-help leaflets were helpful .


The findings demonstrate that augmented CBSH provides a relatively simple and accessible intervention that can result in a clinically significant reduction in social anxiety .


The augmented intervention has potential and might be further developed and evaluated in subsequent trials .


In the final analysis of the phase 3 COU-AA-301 study , abiraterone acetate plus prednisone significantly prolonged overall survival compared with prednisone alone in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy .


Here , we present the final analysis of an early-access protocol trial that was initiated after completion of COU-AA-301 to enable worldwide preapproval access to abiraterone acetate in patients with metastatic castration-resistant prostate cancer progressing after chemotherapy .


We did a multicentre , open-label , early-access protocol trial in 23 countries .


We enrolled patients who had metastatic castration-resistant prostate cancer progressing after taxane chemotherapy .


Participants received oral doses of abiraterone acetate ( 1000 mg daily ) and prednisone ( 5 mg twice a day ) in 28-day cycles until disease progression , development of sustained side-effects , or abiraterone acetate becoming available in the respective country .


The primary outcome was the number of adverse events arising during study treatment and within 30 days of discontinuation .