LG mouthrinse was able to reduce oral malodour and appeared to be safe .


The overall satisfaction of the mouthrinse was acceptable .


However , the spiciness and taste of the mouthrinse need to be improved .


This study demonstrated that the LG mouthrinse significantly reduced oral malodour .


This mouthrinse would be another alternative mouthrinse choice for prevention of malodour , plaque and gingivitis .


The goal of aneurysm treatment is occlusion of an aneurysm without morbidity or mortality .


Using well-established , traditional endovascular techniques , this is generally achievable with a high level of safety and efficacy .


These techniques involve either constructive treatment of the aneurysm ( coils with or without an intravascular stent ) or deconstruction ( coil occlusion ) of the aneurysm and the parent artery .


While established as safe and efficacious , the constructive treatment of large and giant aneurysms with coils has typically been associated with relatively lower rates of complete occlusion and higher rates of recurrence .


Parent artery deconstruction , though immediately efficacious in achieving complete and durable occlusion , does require occlusion of a major intracranial blood vessel and is associated with risk of stroke .


Flow diversion represents a new technology that can be used to constructively treat large and giant aneurysms .


Once excluded successfully , the vessel reconstruction and aneurysm occlusion appears durable .


The ability to definitively reconstruct cerebral blood vessels is an attractive approach to these large and giant complex aneurysms and allows the treatment of some aneurysms which were previously not amenable to other therapies .


By comparison , conventional coiling techniques have traditionally been used for endovascular treatment of large aneurysms .


Large and giant aneurysms that are amenable to either flow diversion or traditional endovascular treatment will be randomized to either therapy with FDA ( or appropriate regulatory body ) approved devices .


The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up .


This paper details the trial design of the LARGE trial , a blinded , prospective randomized trial of large anterior circulation aneurysms amenable to either traditional endovascular treatments using coils or reconstruction with flow diverters .


Sixty percent of cancer survivors are 65years of age or older .


Cancer and its treatments lead to cancer-related fatigue and many other side effects , in turn , creating substantial global side-effect burden ( total burden from all side effects ) which , ultimately , compromises functional independence and quality of life .


Various modes of exercise , such as yoga , reduce cancer-related fatigue and global side-effect burden in younger cancer survivors , but no studies have specifically examined the effects of yoga on older cancer survivors .


The purpose of this study was to assess the effects of a 4-week yoga intervention ( Yoga for Cancer Survivors : YOCAS ) on overall cancer-related fatigue , and due to its multidimensional nature , the subdomains of cancer-related fatigue ( general , physical , emotional , and mental ) and global side-effect burden in older cancer survivors .


We conducted a secondary analysis on data from a multicenter phase III randomized controlled clinical trial with 2 arms ( standard care and standard care plus a 4-week YOCAS intervention ) .


The sample for this secondary analysis was 97 older cancer survivors ( 60years of age ) , between 2months and 2years post-treatment , who participated in the original trial .


Participants in the YOCAS intervention arm reported significantly lower cancer-related fatigue , physical fatigue , mental fatigue , and global side-effect burden than participants in the standard care arm following the 4-week intervention period ( p < 0.05 ) .


YOCAS is an effective standardized yoga intervention for reducing cancer-related fatigue , physical fatigue , mental fatigue , and global side-effect burden among older cancer survivors .


To observe the clinical effect of acupuncture therapy combined with Lipitor in the treatment of primary hyperlipidemia ( spleen deficiency and food stagnation type ) .


Sixty primary hyperlipidemia patients ( spleen deficiency and food stagnation type ) were equally randomized into medication group and acupuncture plus medication group .


Patients of both groups were treated by oral administration of Lipitor ( 20 mg/tablet , one tablet per day ) for 6 weeks .


Manual acupuncture stimulation was applied to Baihui ( GV 20 ) , Zhongwan ( CV 12 ) , and bilateral Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) , Yin-lingquan ( SP 9 ) and Fenglong ( ST 40 ) for 40 min , twice daily for 6 weeks except the weekends .


Serum total cholesterol ( TC ) , triglyceride ( TG ) , high density lipoprotein-cholesterol ( HDL-C ) , low density lipoprotein-cholesterol ( LDL-C ) were detected by using a full-automatic biochemistry analyzer before and after the treatment .


The therapeutic effect was assessed according to the standards described in `` Guide Principles for Clinical Researches of New Chinese Herbal Drugs '' .


After the treatment , the levels of serum TC , TG of the two groups were significantly decreased in comparison with pre-treatment in the same one group ( P < 0.05 ) , and the therapeutic effect of the acupuncture + medication group was significantly superior to that of simple medication group in lowering serum TC , TG and LDL-C levels and heightening HDL-C levels ( P < 0.05 ) .


Of the two 30 cases in the medication and acupuncture + medication groups , 2 ( 6.7 % ) and 7 ( 23.3 % ) were basically controlled in their blood-lipid levels , 10 ( 33.3 % ) and 15 ( 50.0 % ) had a marked improvement , 10 ( 33.3 % ) and 6 ( 20.0 % ) were improved , and 8 ( 26.7 % ) and 2 ( 6.7 % ) were invalid , with the effective rates being 73.3 % and 93.3 % , respectively .


Acupuncture combined with administration of Lipitor is effective in improving primary hyperlipidemia in patients , which is superior to administration of simple Lipitor .


To evaluate the feasibility of using a reduced radiation dose and reduced iodine intake ( i.e. , `` double low '' : low tube voltage/low iodine dose contrast agent ) scanning protocol and the adaptive iterative dose reduction ( AIDR ) reconstruction algorithm in coronary heart disease ( CHD ) patients with a BMI of 26-30kg / m ( 2 ) .


One-hundred and seventy-nine consecutive CHD patients with a body mass index > 26kg/m but < 30kg/m were randomly assigned to two groups ( group A : 53 men , 39 women , average age 61.8311.84 years , and group B : 40 men , 47 women , average age 62.2511.37 years ) based on tube voltage , contrast agent , and algorithm used .


Group A underwent the `` double low '' protocol ( iodixanol at 270mg iodine/ml , 100kVp tube voltage , and AIDR ) .


Group B received the conventional protocol [ iopamidol at 370mg iodine/ml , 120kVp tube voltage , and filtered back projection ( FBP ) ] .


The volume CT dose index ( CTDIvol ) , dose-length product ( DLP ) , effective dose ( ED ) , and iodine intake of patients in `` double low '' group A were significantly lower than the `` conventional '' group B ( p < 0.001 ) .


The mean intraluminal attenuation and contrast enhancement in group A were also significantly less than group B ( p < 0.001 ) , whereas the image noise using AIDR in group A was significantly lower than group B using FBP ( p < 0.001 ) .


However , the signal-to - noise ratio ( SNR ) , contrast-to-noise ratio ( CNR ) , and image-quality scores between the two groups were comparable .


Use of 320-row CT with a `` double low '' scanning protocol for CCTA in patients with a BMI of 26-30kg / m ( 2 ) not only provided images of diagnostic quality but also reduced both radiation dose and iodine intake during scanning .


A self-enhancing loop between impaired inhibitory control under alcohol and alcohol consumption has been proposed as a possible mechanism underlying dysfunctional drinking in susceptible people .


However , the neural underpinnings of alcohol-induced impairment of inhibitory control are widely unknown .


We measured inhibitory control in 50 young adults with a stop-signal task during functional magnetic resonance imaging .


In a single-blind placebo-controlled cross-over design , all participants performed the stop-signal task once under alcohol with a breath alcohol concentration of .6 g/kg and once under placebo .


In addition , alcohol consumption was assessed with a free-access alcohol self-administration paradigm in the same participants .


Inhibitory control was robustly decreased under alcohol compared with placebo , indicated by longer stop-signal reaction times .


On the neural level , impaired inhibitory control under alcohol was associated with attenuated brain responses in the right fronto-temporal portion of the inhibition network that supports the attentional capture of infrequent stop-signals and subsequent updating of action plans from response execution to inhibition .


Furthermore , the extent of alcohol-induced impairment of inhibitory control predicted free-access alcohol consumption .


We suggest that during inhibitory control alcohol affects cognitive processes preceding actual motor inhibition .


Under alcohol , decreased brain responses in right fronto-temporal areas might slow down the attentional capture of infrequent stop-signals and subsequent updating of action plans , which leads to impaired inhibitory control .


In turn , pronounced alcohol-induced impairment of inhibitory control might enhance alcohol consumption in young adults , which might promote future alcohol problems .


Ex vivo evidence suggests that cyclo-oxygenase ( COX ) 2-preferential inhibitor nonsteroidal anti-inflammatory drugs ( NSAIDs ) , such as meloxicam , have a less detrimental effect on intestinal healing than flunixin meglumine ( FM ) .


Whether this translates to a beneficial effect in horses with naturally occurring strangulating small intestinal ( SSI ) lesions is unknown .


To compare the clinical outcome of horses with naturally occurring SSI lesions treated with meloxicam or FM .


Randomised prospective study .


Cases presenting to the Royal Veterinary College Equine Referral Hospital and Bell Equine Veterinary Clinic during 2010 and 2011 in which an SSI lesion was identified at exploratory laparotomy were eligible for inclusion .


Horses received either 1.1 mg/kg bwt FM or 0.6 mg/kg bwt meloxicam i.v. q. 12h .


Clinical outcomes and clinical and laboratory parameters associated with endotoxaemia were compared between groups .


Sixty cases were enrolled , 32 horses received FM and 28 received meloxicam .


There was no difference in signalment , physical examination or surgical factors between groups .


The overall survival to discharge was 81 % ; there was no difference in survival ( P = 0.14 ) or incidence of post operative ileus ( P = 0.25 ) between groups .


There was no significant difference between the plasma lipopolysaccharide ( LPS ) concentrations at 0h ( P = 0.18 ) or 48h ( P = 0.60 ) ; however , there was a significant difference between neutrophil count at 48h ( P < 0.05 ) and at 96h ( P < 0.01 ) with significantly greater cell numbers in horses receiving meloxicam compared with FM .


Blinded pain score evaluation showed that more horses receiving meloxicam showed gross signs of pain than those treated with FM ( P = 0.04 ) .


Nonsteroidal anti-inflammatory drug choice did not affect major clinical outcomes in horses with SSI lesions but had some effects on signs of pain .


This study provides no evidence to recommend one NSAID treatment above another based on survival or the incidence of ileus ; however , evaluation of a larger number of cases is required .


Long-term ventilated intensive care patients frequently require tracheostomy .


Although overall risks are low , serious immediate and late complications still arise .


Real-time ultrasound guidance has been proposed to decrease complications and improve the accuracy of the tracheal puncture .


We aimed to compare the procedural safety and efficacy of real-time ultrasound guidance with the traditional landmark approach during percutaneous dilatational tracheostomy ( PDT ) .


A total of 50 patients undergoing PDT for clinical indications were randomly assigned , after obtaining informed consent , to have the tracheal puncture procedure carried out using either traditional anatomical landmarks or real-time ultrasound guidance .


Puncture position was recorded via bronchoscopy .


Blinded assessors determined in a standardised fashion the deviation of the puncture off midline and whether appropriate longitudinal position between the first and fourth tracheal rings was achieved .


Procedural safety and efficacy data , including complications and number of puncture attempts required , were collected .


In total , 47 data sets were evaluable .


Real-time ultrasound guidance resulted in significantly more accurate tracheal puncture .


Mean deviation from midline was 153 versus 355 ( P = 0.001 ) .


The proportion of appropriate punctures , defined a priori as 030 from midline , was significantly higher : 20 ( 87 % ) of 23 versus 12 ( 50 % ) of 24 ( RR = 1.74 ; 95 % CI = 1.13 to 2.67 ; P = 0.006 ) .


First-pass success rate was 20 ( 87 % ) of 23 in the ultrasound group and 14 ( 58 % ) of 24 in the landmark group ( RR = 1.49 ; 95 % CI = 1.03 to 2.17 ; P = 0.028 ) .


The observed decrease in procedural complications was not statistically significant : 5 ( 22 % ) of 23 in the ultrasound group versus 9 ( 37 % ) of 24 in the landmark group ( RR = 0.58 ; 95 % CI = 0.23 to 1.47 ; P = 0.24 ) .


Ultrasound guidance significantly improved the rate of first-pass puncture and puncture accuracy .


Fewer procedural complications were observed ; however , this did not reach statistical significance .


These results support wider general use of real-time ultrasound guidance as an additional tool to improve PDT .


Australian New Zealand Clinical Trials Registry ID : ACTRN12611000237987 ( registered 4 March 2011 ) .


The United Nations Millennium Development Goals include targets for the health of children under five years old .


Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty .


However , there is a lack of reliable evidence to support this .


In addition , microfinance schemes may have adverse effects on health , for example due to increased indebtedness .


Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women 's self-help groups ( SHGs ) .


This pilot study , conducted in rural Bihar ( India ) , will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention .


We have designed a cluster randomized trial in which participating tolas ( small communities within villages ) will be randomized to either receive early ( SHGs and microfinance at baseline ) or late intervention ( SHGs and microfinance after 18months ) .


Using predesigned questionnaires , demographic , and mortality data for the last year and information about participating mothers and their children will be collected and the weight , height , and mid upper arm circumference ( MUAC ) of children will be measured at baseline and at 18months .


The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36months .


The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18months .


Secondary outcome measures will be the mortality rate , mean weight for age , height for age , prevalence of underweight , stunting , and wasting among children under five years of age .


Despite economic progress , marked inequalities in child health persist in India and Bihar is one of the worst affected states .


There is a need to evaluate programs that may alleviate poverty and improve health .


This study will help to inform the design of a definitive trial to determine if the Rojiroti scheme can improve the nutrition and survival of children under five years of age in deprived rural communities .


Clinicaltrials.gov ( study ID : NCT01845545 ) .


Registered on 24 April 2013 .


The potential for small-quantity lipid-based nutrient supplements ( LNS ) to promote growth and development after 6 mo of age is currently being investigated .


Because infants self-regulate energy intake , consumption of LNS may reduce breast milk intake and potentially decrease the beneficial effects of breast milk .


The objective was to test the hypothesis that the breast milk intake of 9 - to 10-mo-old rural Malawian infants receiving LNS would not be lower than that of infants receiving no supplementation .


This was a substudy of the International Lipid-based Nutrient Supplements ( iLiNS ) DOSE trial , in which 6-mo-old infants were randomly assigned to receive 10 , 20 , or 40 g LNS/d containing 56 , 117 , or 241 kcal/d , respectively , or no LNS until 18 mo of age .


A subset was randomly selected to estimate breast milk intake at 9-10 mo of age with the dose-to-mother deuterium oxide dilution method .


The noninferiority margin was < 10 % of total energy requirements .


Baseline characteristics ( n = 376 ) were similar across groups .


The mean ( SD ) daily breast milk intake of unsupplemented infants was 730 226 g.


The differences ( 95 % CIs ) in mean intake of infants provided with 10 , 20 , or 40 g LNS/d , compared with controls , were +62 ( -18 , +143 ) , +30 ( -40 , +99 ) , and +2 ( -68 , +72 ) g/d , respectively .


Non-breast milk oral water intake did not differ by group ( P = 0.39 ) and was inversely ( r = -0.22 , P < 0.01 ) associated with breast milk intake .


In this rural Malawian population , breast milk intake at 9-10 mo of age was not reduced by supplementation with complementary foods with 10-40 g LNS/d .


In the United States , data from federally funded genomics studies are stored in national databases , which may be accessible to anyone online ( public release ) or only to qualified researchers ( restricted release ) .


The availability of such data exposes participants to privacy risk and limits the ability to withdraw from research .


This exposure is especially challenging for pediatric participants , who are enrolled in studies with parental permission .


The current study examines genomic research participants ' attitudes to explore differences in data sharing ( DS ) preferences between parents of pediatric patients and adult patients .


A total of 113 parents of pediatric patients and 196 adult participants from 6 genomics studies were randomly assigned to 3 experimental consent forms .


Participants were invited to a follow-up structured interview exploring DS preferences , study understanding , and attitudes .


Descriptive analyses and regression models were built on responses .


Most parents ( 73.5 % ) and adult participants ( 90.3 % ) ultimately consented to broad public release .


However , parents were significantly more restrictive in their data release decisions , not because of understanding or perceived benefits of participation but rather autonomy and control .


Parents want to be more involved in the decision about DS and are significantly more concerned than adult participants about unknown future risks .


Parents have the same altruistic motivations and grasp of genomics studies as adult participants .


However , they are more concerned about future risks to their child , which probably motivates them to choose more restrictive DS options , but only when such options are made available .


To evaluate the safety , tolerability and immunogenicity of three different doses ( 5 , 25 and 50 g ) of the novel antituberculous vaccine RUTI compared to placebo in subjects with latent tuberculosis infection .


Double-blind , randomized , placebo-controlled Phase II Clinical Trial ( 95 patients randomized ) .


Three different RUTI doses and placebo were tested , randomized both in HIV-positive ( n = 47 ) and HIV-negative subjects ( n = 48 ) , after completion of one month isoniazid ( INH ) pre-vaccination .


Each subject received two vaccine administrations , 28 Days apart .


Five patients withdrew and 90 patients completed the study .


Assessment of safety showed no deaths during study .


Two subjects had serious adverse events one had a retinal detachment while taking INH and was not randomized and the other had a severe local injection site abscess on each arm and was hospitalized ; causality was assessed as very likely and by the end of the study the outcome had resolved .


All the patients except 5 ( 21 % ) patients of the placebo group ( 3 HIV + and 2 HIV - ) reported at least one adverse event ( AE ) during the study .


The most frequently occurring AEs among RUTI recipients were ( % in HIV + / - ) : injection site reactions [ erythema ( 91/92 ) , induration ( 94/92 ) , local nodules ( 46/25 ) , local pain ( 66/75 ) , sterile abscess ( 6/6 ) , swelling ( 74/83 ) , ulcer ( 20/11 ) , headache ( 17/22 ) and nasopharyngitis ( 20/5 ) ] .


These events were mostly mild and well tolerated .


Overall , a polyantigenic response was observed , which differed by HIV - status .


The best polyantigenic response was obtained when administrating 25 g RUTI , especially in HIV-positive subjects which was not increased after the second inoculation .


This Phase II clinical trial demonstrates reasonable tolerability of RUTI .


The immunogenicity profile of RUTI vaccine in LTBI subjects , even being variable among groups , allows us considering one single injection of one of the highest doses in future trials , preceded by an extended safety clinical phase .


ClinicalTrials.gov NCT01136161 .


Regular monitoring of the international normalized ratio ( INR ) is crucial for dose adjustment of vitamin K antagonists ( VKA ) to maximize time in therapeutic range ( TTR ) .


We compared the use of a mobile electronic assistant INRPlus which proposes patient-specific fluindione doses , to standard fluindione management in a cluster randomized controlled study .


Twenty clusters of six general practitioners were randomized to adjust fluindione doses in VKA-treated patients either using INRPlus or according to routine practice .


TTR was measured over 6 months , along with time spent above or below the recommended INR range , frequency of measurements and related complications .


Of the 595 included patients , 551 were assessable ( 259 INRPlus , 292 control ) and had a mean of 1.6 INR measurements/month .


TTR was not significantly different between the two groups , 72.7 % [ Q1 : 58.1 % ; Q3 : 90 % ] in INRPlus patients and 71.2 % [ Q1 : 54.8 % ; Q3 : 88.2 % ] in control patients ( p = 0.445 ) .


At least 60 % time within reference ranges was reported in 73.4 % of INRPlus patients and 67.1 % of control patients ( relative risk 1.09 , 95 % CI 0.98-1 .22 , p = 0.115 ) .


No significant differences were reported between the two groups for time outside reference ranges , frequency of measurements or complications .


Eighty-two percent ( 82 % ) of patients complying with INRPlus-proposed doses spent more than 60 % of TTR versus 66.9 % of non-compliant patients and 67.1 % of reference patients .


In this trial , the use of the INRPlus electronic assistant resulted in a non-significant improvement in TTR that may be due to a higher than expected TTR in the control group .


Hospital malnutrition is a highly prevalent problem that affects patient morbidity and mortality resulting in longer hospital stays and increased healthcare costs .


Although there is no single nutritional screening method , subjective global assessment ( SGA ) may be a useful , inexpensive , and easily reproducible tool .


A cross-sectional , observational , randomized study was conducted in 197 patients in a tertiary hospital .


SGA , anthropometric data , and biochemical parameters were used to assess the nutritional status of study patients .


Fifty percent of subjects were malnourished according to SGA .


A higher prevalence of malnutrition was found in medical ( 53 % ) as compared to surgical departments ( 47 % ) .


Half the subjects ( 50 % ) had malnutrition by SGA , but only 37.8 % received nutritional treatment during their hospital stay .


Mean hospital stay was longer for patients malnourished ( 13.5 days ) or at risk of malnutrition ( 12.1 days ) as compared to well nourished subjects ( 6.97 days ) .


SGA significantly correlated ( P < .012 ) with anthropometric and biochemical malnutrition parameters .


Prevalence of hospital malnutrition is very high in both medical and surgical departments and is inadequately treated .


SGA is a useful tool for screening hospital malnutrition because of its high degree of correlation with anthropometric and biochemical parameters .


To compare the immunogenicity and safety between full-dose ( 15 g ) intramuscular ( i.m. ) and full-dose ( 15 g ) intradermal ( i.d. ) immunization of the trivalent influenza vaccine in nursing home older adults .


A single-center , randomized , controlled , open-label , parallel group trial from October 2013 to April 2014 .


Nine nursing homes in Hong Kong .


Hundred nursing home older adults ( mean age : 82.9 7.4 years ) .


Fifty received i.d. ( Intanza ) and 50 received i.m. ( Vaxigrip ) vaccination .


Baseline measurements included demographics , comorbidity , frailty and nutritional status .


Day 21 and day 180 immunogenicity ( seroconversion rate , seroprotection rate , geometric mean titer [ GMT ] fold increase in antibody titer ) using hemagglutination-inhibition and adverse events were measured .


Noninferiority and superiority of i.d. compared with i.m. vaccination in immunogenicity were analyzed .


The study was registered on ClinicalTrials.gov ; identifier : NCT 01967368 .


At day 21 , noninferiority in immunogenicity of the i.d. vaccination was demonstrated .


The seroconversion rate of the H1N1 strain was significantly higher in the i.d. group .


At day 180 , immunogenicity of both groups fell but the GMT of all strains in i.d. group was higher and the difference was significant for H3N2 strain .


The seroconversion rate and GMT fold increase of H3N2 strain was significantly higher in the i.d. group .


Local adverse events was significantly more in i.d. group , but they were mild and resolved in 72 hours .


I.d. vaccination is noninferior , and even superior in some parts of immunogenicity assessment , to i.m. vaccination without compromising safety in nursing home older adults .


I.d. vaccination is a good alternative to i.m. vaccination in this population .


Calcineurin inhibitors ( CNIs ) reduce short-term kidney transplant failure , but might contribute to transplant failure in the long-term .


The role of alemtuzumab ( a potent lymphocyte-depleting antibody ) as an induction treatment followed by an early reduction in CNI and mycophenolate exposure and steroid avoidance , after kidney transplantation is uncertain .


We aimed to assess the efficacy and safety of alemtuzumab-based induction treatment compared with basiliximab-based induction treatment in patients receiving kidney transplants .


For this randomised trial , we enrolled patients aged 18 years and older who were scheduled to receive a kidney transplant in the next 24 h from 18 transplant centres in the UK .


Using minimised randomisation , we randomly assigned patients ( 1:1 ; minimised for age , sex , and immunological risk ) to either alemtuzumab-based induction treatment ( ie , alemtuzumab followed by low-dose tacrolimus and mycophenolate without steroids ) or basiliximab-based induction treatment ( basiliximab followed by standard-dose tacrolimus , mycophenolate , and prednisolone ) .


Participants were reviewed at discharge from hospital and at 1 , 3 , 6 , 9 , and 12 months after transplantation .


The primary outcome was biopsy-proven acute rejection at 6 months , analysed by intention to treat .


The study is registered at ClinicalTrials.gov , number NCT01120028 , and isrctn.org , number ISRCTN88894088 .


Between Oct 4 , 2010 , and Jan 21 , 2013 , we randomly assigned 852 participants to treatment : 426 to alemtuzumab-based treatment and 426 to basiliximab-based treatment .


Overall , individuals allocated to alemtuzumab-based treatment had a 58 % proportional reduction in biopsy-proven acute rejection compared with those allocated to basiliximab-based treatment ( 31 [ 7 % ] patients in the alemtuzumab group vs 68 [ 16 % ] patients in the basiliximab group ; hazard ratio ( HR ) 042 , 95 % CI 028-064 ; log-rank p < 00001 ) .


We detected no between-group difference in treatment effect on transplant failure during the first 6 months ( 16 [ 4 % ] patients vs 13 [ 3 % ] patients ; HR 123 , 059-255 ; p = 058 ) or serious infection ( 135 [ 32 % ] patients vs 136 [ 32 % ] patients ; HR 102 , 080-129 ; p = 088 ) .


During the first 6 months after transplantation , 11 ( 3 % ) patients given alemtuzumab-based treatment and six ( 1 % ) patients given basiliximab-based treatment died ( HR 179 , 95 % CI 066-483 ; p = 025 ) .


Compared with standard basiliximab-based treatment , alemtuzumab-based induction therapy followed by reduced CNI and mycophenolate exposure and steroid avoidance reduced the risk of biopsy-proven acute rejection in a broad range of patients receiving a kidney transplant .


Long-term follow-up of this trial will assess whether these effects translate into differences in long-term transplant function and survival .


UK National Health Service Blood and Transplant Research and Development Programme , Pfizer , and Novartis UK .


Initially , unresectable colorectal liver metastases can be resected after response to chemotherapy .


While cetuximab has been shown to increase response and resection rates , the survival outcome for this conversion strategy needs further evaluation .


Patients with technically unresectable and/or 5 liver metastases were treated with FOLFOX/cetuximab ( arm A ) or FOLFIRI/cetuximab ( arm B ) and evaluated with regard to resectability every 2 months .


Tumour response and secondary resection data have been reported previously .


A final analysis of overall survival ( OS ) and progression-free survival ( PFS ) was carried out in December 2012 .


Between December 2004 and March 2008 , 56 patients were randomised to arm A , 55 to arm B.


The median OS was 35.7 [ 95 % confidence interval ( CI ) 27.2-44 .2 ] months [ arm A : 35.8 ( 95 % CI 28.1-43 .6 ) , arm B : 29.0 ( 95 % CI 16.0-41 .9 ) months , HR 1.03 ( 95 % CI 0.66-1 .61 ) , P = 0.9 ] .


The median PFS was 10.8 ( 95 % CI 9.3-12 .2 ) months [ arm A : 11.2 ( 95 % CI 7.2-15 .3 ) , arm B : 10.5 ( 95 % CI 8.9-12 .2 ) months , HR 1.18 ( 95 % CI 0.79-1 .74 ) , P = 0.4 ] .


Patients who underwent R0 resection ( n = 36 ) achieved a better median OS [ 53.9 ( 95 % CI 35.9-71 .9 ) months ] than those who did not [ 21.9 ( 95 % CI 17.1-26 .7 ) months , P < 0.001 ] .


The median disease-free survival for R0 resected patients was 9.9 ( 95 % CI 5.8-14 .0 ) months , and the 5-year OS rate was 46.2 % ( 95 % CI 29.5 % to 62.9 % ) .


This study confirms a favourable long-term survival for patients with initially sub-optimal or unresectable colorectal liver metastases who respond to conversion therapy and undergo secondary resection .


Both FOLFOX/FOLFIRI plus cetuximab , appear to be appropriate regimens for ` conversion ' treatment in patients with K-RAS codon 12/13/61 wild-type tumours .


Thus , liver surgery can be considered curative or alternatively as an additional ` line of therapy ' in those patients who are not cured .


NCT00153998 , www.clinicaltrials.gov .


Ankle fractures account for 9 % of all fractures with a quarter of these occurring in adults over 60years .


The short term disability and long-term consequences of this injury can be considerable .


Current opinion favours open reduction and internal fixation ( ORIF ) over non-operative treatment ( fracture manipulation and the application of a standard moulded cast ) for older people .


Both techniques are associated with complications but the limited published research indicates higher complication rates of fracture malunion ( poor position at healing ) with casting .


The aim of this study is to compare ORIF with a modification of existing casting techniques , Close Contact Casting ( CCC ) .


We propose that CCC may offer an equivalent functional outcome to ORIF and avoid the risks associated with surgery .


This study is a pragmatic multi-centre equivalence randomised controlled trial .


620 participants will be randomised to receive ORIF or CCC after sustaining an isolated displaced unstable ankle fracture .


Participants will be recruited from a minimum of 20 National Health Service ( NHS ) acute hospitals throughout England and Wales .


Participants will be aged over 60years and be ambulatory prior to injury .


Follow-up will be at six weeks and six months after randomisation .


The primary outcome is the Olerud & Molander Ankle Score , a functional patient reported outcome measure , at 6months .


Follow-up will also include assessments of mobility , ankle range of movement , health related quality of life and complications .


The six-month follow-up will be conducted face-to-face by an assessor blinded to the allocated intervention .


A parallel economic evaluation will consider both a health service and a broader societal perspective including the individual and their family .


In order to explore patient experience of their treatment and recovery , a purposive sample of 40 patients will also be interviewed using a semi-structured interview schedule between 6-10weeks post treatment .


This multicentre study was open to recruitment July 2010 and recruitment is due to be completed in December 2013 .


Current Controlled Trials ISRCTN04180738 .


Dyad practice may be as effective as individual practice during clinical skills training , improve students ' confidence , and reduce costs of training .


However , there is little evidence that dyad training is non-inferior to single-student practice in terms of skills transfer .


This study was conducted to compare the effectiveness of simulation-based ultrasound training in pairs ( dyad practice ) with that of training alone ( single-student practice ) on skills transfer .


In a non-inferiority trial , 30 ultrasound novices were randomised to dyad ( n = 16 ) or single-student ( n = 14 ) practice .


All participants completed a 2-hour training programme on a transvaginal ultrasound simulator .


Participants in the dyad group practised together and took turns as the active practitioner , whereas participants in the single group practised alone .


Performance improvements were evaluated through pre - , post - and transfer tests .


The transfer test involved the assessment of a transvaginal ultrasound scan by one of two clinicians using the Objective Structured Assessment of Ultrasound Skills ( OSAUS ) .


Thirty participants completed the simulation-based training and 24 of these completed the transfer test .


Dyad training was found to be non-inferior to single-student training : transfer test OSAUS scores were significantly higher than the pre-specified non-inferiority margin ( delta score 7.8 % , 95 % confidence interval -3.8 -19.6 % ; p = 0.04 ) .


More dyad ( 71.4 % ) than single ( 30.0 % ) trainees achieved OSAUS scores above a pre-established pass/fail level in the transfer test ( p = 0.05 ) .


There were significant differences in performance scores before and after training in both groups ( pre - versus post-test , p < 0.01 ) with large effect sizes ( Cohen 's d = 3.85 ) and no significant interactions between training type and performance ( p = 0.59 ) .


The dyad group demonstrated higher training efficiency in terms of simulator score per number of attempts compared with the single-student group ( p = 0.03 ) .


Dyad practice improves the efficiency of simulation-based training and is non-inferior to individual practice in terms of skills transfer .


Google Street View provides a valuable and efficient alternative to observe the physical environment compared to on-site fieldwork .


However , studies on the use , reliability and validity of Google Street View in a cycling-to-school context are lacking .


We aimed to study the intra - , inter-rater reliability and criterion validity of EGA-Cycling ( Environmental Google Street View Based Audit - Cycling to school ) , a newly developed audit using Google Street View to assess the physical environment along cycling routes to school .


Parents ( n = 52 ) of 11-to-12-year old Flemish children , who mostly cycled to school , completed a questionnaire and identified their child 's cycling route to school on a street map .


Fifty cycling routes of 11-to-12-year olds were identified and physical environmental characteristics along the identified routes were rated with EGA-Cycling ( 5 subscales ; 37 items ) , based on Google Street View .


To assess reliability , two researchers performed the audit .


Criterion validity of the audit was examined by comparing the ratings based on Google Street View with ratings through on-site assessments .


Intra-rater reliability was high ( kappa range 0.47-1 .00 ) .


Large variations in the inter-rater reliability ( kappa range -0.03 -1.00 ) and criterion validity scores ( kappa range -0.06 -1.00 ) were reported , with acceptable inter-rater reliability values for 43 % of all items and acceptable criterion validity for 54 % of all items .


EGA-Cycling can be used to assess physical environmental characteristics along cycling routes to school .


However , to assess the micro-environment specifically related to cycling , on-site assessments have to be added .


Preoperative nutrition is beneficial for malnourished cancer patients .


Yet , there is little evidence whether or not it should be given to nonmalnourished patients .


The aim of this study was to assess the need to introduce preoperative nutritional support in patients without malnutrition at qualification for surgery .


This was a prospective , two-arm , randomized , controlled , open-label study .


Patients in interventional group received nutritional supplementation for 14 days before surgery , while control group kept on to their everyday diet .


Each patient 's nutritional status was assessed twice -- at qualification ( weight loss in 6 months , laboratory parameters : albumin , total protein , transferrin , and total lymphocyte count ) and 1 day before surgery ( change in body weight and laboratory parameters ) .


After surgery , all patients were followed up for 30 days for postoperative complications .


Fifty-four patients in interventional and 48 in control group were analyzed .


In postoperative period , patients in control group suffered from significantly higher ( p < 0.001 ) number of serious complications compared with patients receiving nutritional supplementation .


Moreover , levels of all laboratory parameters declined significantly ( p < 0.001 ) in these patients , while in interventional arm were stable ( albumin and total protein ) or raised ( transferrin and total lymphocyte count ) .


Preoperative nutritional support should be introduced for nonmalnourished patients as it helps to maintain proper nutritional status and reduce number and severity of postoperative complications compared with patients without such support .


Juvenile Cerebral Palsy -- is caused by damage of the motor control centers of the developing brain ( cerebral refers to the cerebrum , which is the affected area of the brain , although the disorder probably involves connections between the cortex and other parts of the brain and palsy refers to disorder of movement ) .


The clinical symptoms of juvenile cerebral palsy are very diversified and include gross and fine motor-coordination disorders , manual ability , locomotion , perception and response , speech , psychomotor retardation , emotional disorders .


The primary therapeutic problem in children with cerebral palsy is learning to move in a lower position and learning to walk .


The aim of this research is evaluation the action of the botulinum toxin on gait pattern of children with cerebral palsy .


Application of a comprehensive BTS analysis of gait will get accurate , consistent EBM ( Evidence Base Medicine ) results .


The children with pyramidal syndrome of juvenile cerebral palsy have been included in the examinations .


The children have been divided into 2 random groups : group I -- children treated with standard therapy a neurodevelopmental rehabilitation and classic kinesiotherapy , group II -- hildren treated with standard therapy -- eurodevelopmental rehabilitation , classic kinesiotherapy and a botulinum toxin .


The children were examined three times : before the therapy , after 6 weeks of treatment and after 3 months of treatment .


In the research BTS comprehensive motion analysis system have been used where influence of toxin botulin on walk stereotype of children was assessed .


The treatment connected with standard rehabilitation and using botulinum toxin brings quicker walk improvement .


Comparing the above treatment methods of influence on the walk stereotype of children with juvenile cerebral palsy , we can confirm , that standard treatment brings regular improvement , still , it requires longer period of time , often even 3 months .


Using botulinum toxin brings quicker walk improvement , after 6 weeks only , which is a clear , but short-term result .


Botulinum toxin has a positive effect on gait parameters in children , especially until 3 months , after this time parameters are not better .


Concomitant treatment with standard therapy and botulinum toxin should be used becouse it is possitive treatment for locomotion of children with cerebral palsy .


Appearance-based education shows promise in promoting sunscreen use although resource-intensive methods used in prior studies preclude wide dissemination .


Appearance-based video education can be made easily accessible .


We sought to compare the effectiveness of appearance-based video education with that of health-based video education in improving sunscreen use and knowledge .


In a randomized controlled trial , participants viewed either an appearance-based video on ultraviolet-induced premature aging or a health-based video emphasizing ultraviolet exposure and skin cancer risk .


Fifty high-school students participated in the study , conducted from February through March 2012 .


The health-based group had a nonstatistically significant increase in sunscreen use ( 0.9 1.9 d/wk , P = .096 ) , whereas the appearance-based group demonstrated a statistically significant increase in sunscreen use ( 2.8 2.2 , P < .001 ) .


Between-group comparisons revealed that the appearance-based group applied sunscreen at significantly greater frequencies compared with the health-based group ( 2.21.4 vs 0.2 0.6 , P < .001 ) .


Knowledge scores significantly improved in both study groups .


Thedifference in knowledge scores between the study groups was not significant .


The study population may not reflect the general population .


Appearance-based video education appears to be effective in promoting sunscreen use and knowledge in adolescents .


Oritavancin is a lipoglycopeptide with bactericidal activity against gram-positive bacteria .


Its concentration-dependent activity and prolonged half-life allow for single-dose treatment .


We conducted a randomized , double-blind trial in which adults with acute bacterial skin and skin-structure infections received either a single intravenous dose of 1200 mg of oritavancin or a regimen of intravenous vancomycin twice daily for 7 to 10 days .


Three efficacy end points were tested for noninferiority .


The primary composite end point was defined as cessation of spreading or reduction in lesion size , absence of fever , and no need for administration of a rescue antibiotic 48 to 72 hours after administration of oritavancin .


Secondary end points were clinical cure 7 to 14 days after the end of treatment , as determined by a study investigator , and a reduction in lesion size of 20 % or more 48 to 72 hours after administration of oritavancin .


The modified intention-to-treat population comprised 475 patients who received oritavancin and 479 patients who received vancomycin .


All three efficacy end points met the prespecified noninferiority margin of 10 percentage points for oritavancin versus vancomycin : primary end point , 82.3 % versus 78.9 % ( 95 % confidence interval [ CI ] for the difference , -1.6 to 8.4 percentage points ) ; investigator-assessed clinical cure , 79.6 % versus 80.0 % ( 95 % CI for the difference , -5.5 to 4.7 percentage points ) ; and proportion of patients with a reduction in lesion area of 20 % or more , 86.9 % versus 82.9 % ( 95 % CI for the difference , -0.5 to 8.6 percentage points ) .


Efficacy outcomes measured according to type of pathogen , including methicillin-resistant Staphylococcus aureus , were similar in the two treatment groups .


The overall frequency of adverse events was also similar , although nausea was more common among those treated with oritavancin .


A single dose of oritavancin was noninferior to twice-daily vancomycin administered for 7 to 10 days for the treatment of acute bacterial skin and skin-structure infections caused by gram-positive pathogens .


( Funded by the Medicines Company ; SOLO I ClinicalTrials.gov number , NCT01252719 . )


Many interventions targeting college student drinking have focused on negative health effects of drinking heavily ; however , some research suggests that social factors may have a stronger influence on the drinking behaviour of young people .


Moreover , few studies have examined message framing effects in the context of alcohol consumption .


This study investigated the effects of social and health consequence framing on college students ' intentions to engage in heavy drinking .


This study used a 2 2 experimental design with an appended control condition .


One hundred and twenty-four college students ( 74 women ; M ( age ) = 18.9 ) participated in this study for course credit .


Participants read vignettes that were ostensibly written by a recent graduate from the university , who described an episode of drinking in which he or she experienced either social or health consequences .


These consequences were framed as either a gain ( i.e. , positive consequences of not drinking heavily ) or a loss ( i.e. , negative consequences of drinking heavily ) .


After reading the vignette , participants completed a measure of heavy drinking intentions .


Regression analyses revealed that social consequences were associated with lower heavy drinking intentions when framed as a loss and that health consequences were associated with lower heavy drinking intentions when framed as a gain .


These effects were stronger among those who reported higher ( vs. lower ) levels of previous drinking .


Results suggest that interventions that focus on the negative health effects of heavy drinking may be improved by instead emphasizing the negative social consequences of drinking heavily and the positive health consequences of avoiding this behaviour .


Statement of contribution What is already known on this subject ?


Previous studies have shown that gain frames are more effective than loss frames when highlighting the health consequences of health risk behaviours , such as heavy drinking .


The heavy drinking behaviour of young people is influenced by social factors ( e.g. , perceived social consequences ) .


However , little is known about framing effects for social consequences of heavy drinking .


What does this study add ?


This study builds on previous research by demonstrating that a loss frame is more effective than a gain frame when highlighting the social consequences of health risk behaviour .


Framing effects are strongest for those with more previous drinking experience .


Lactobacilli have been found in the neovagina of very low numbers of transsexual women .


We undertook this study to determine whether an orally administered preparation of four lactobacilli strains exerts some measurable effect on the neovaginal microflora of female transsexuals .


60 male to female transsexual women with penile linked neovagina were randomised into two groups .


Women in the intervention group ( n = 33 ) received oral probiotic capsules and women in the control group ( n = 27 ) placebo in for 7 days .


Swabs of the neovagina were taken before and after the therapy .


Comparing the first and second swabs , we observed a significant improvement of the Nugent score in the intervention group 16 ( 48.5 % ) vs. low improvement in control group 4 ( 14.8 % ) ( p < 0.006 ) .


The neovaginal microflora was significantly enriched with lactobacilli after oral supplementation compared to placebo .


In the intervention group , an increase by 10,000600 colony forming units ( CFU ) of presumptive lactobacilli was observed , compared with an increase by 1600100CFU in the control group ( p < 0.0001 ) .


When measured by real-time PCR ( c/ml ) , lactobacilli increased by 1400100c/ml in the intervention group and 300100c/ml in the control group ( p < 0.0001 ) .


There was an improvement of vaginal lactobacilli microflora after of oral supplementation with lactobacilli strains in transsexual women .


There is no single model available to predict the long term survival for patients starting renal replacement therapy ( RRT ) .


The available models either predict survival on dialysis until transplantation , survival on the transplant waiting list , or survival after transplantation .


The aim of this study was to develop a model that includes dialysis survival and survival after an eventual transplantation .


From the Dutch renal replacement registry , patients of 16 years of age or older were included if they started RRT between 1995 and 2005 , still underwent RRT at baseline ( 90 days after the start of RRT ) and were not registered at a non-renal organ transplant waiting list ( N = 13868 ) .


A prediction model of 10-year patient survival after baseline was developed through multivariate Cox regression analysis , in one half of the research group .


Age at start , sex , primary renal disease ( PRD ) and therapy at baseline were included as possible predictors .


A sensitivity analysis has been performed to determine whether listing on the transplant waiting list should be added .


The predictive performance of the model was internally validated .


Calibration and discrimination were computed in the other half of the research group .


Another sensitivity analysis was to assess whether the outcomes differed if the model was developed and tested in two geographical regions , which were less similar than the original development and validation group .


No external validation has been performed .


Survival probabilities were influenced by age , sex , PRD and therapy at baseline ( p < 0.001 ) .


The calibration and discrimination both showed very reasonable results for the prediction model ( C-index = 0.720 and calibration slope for the prognostic index = 1.025 , for the 10 year survival ) .


Adding registration on the waiting list for renal transplantation as a predictor did not improve the discriminative power of the model and was therefore not included in the model .


With the presented prediction model , it is possible to give a reasonably accurate estimation on the survival chances of patients who start with RRT , using a limited set of easily available data .


The ADAGIO study included a large cohort of patients with early PD ( baseline total-UPDRS = 20 ) who were initially randomized to rasagiline and placebo , thereby allowing analyses of symptomatic efficacy .


Post-hoc analyses comparing the efficacy of rasagiline 1mg/day ( n = 288 ) versus placebo ( n = 588 ) on key symptoms at 36 weeks , and on total-UPDRS scores over 72 weeks ( completer population : rasagiline 1mg/day n = 221 , placebo n = 392 ) were performed .


Treatment with rasagiline resulted in significantly better tremor , bradykinesia , rigidity and postural-instability-gait-difficulty scores at week 36 versus placebo .


Whereas the placebo group experienced progressive deterioration from baseline ( 2.6 UPDRS points at week 36 ) , patients in the rasagiline group were maintained at baseline values at week 60 ( UPDRS-change of 0.3 points ) .


At week 72 , patients who had received continuous monotherapy with rasagiline experienced a worsening of only 1.6 points .


Treatment with rasagiline maintained motor function to baseline values for at least a year with significant benefits observed in all key PD motor symptoms .


In medicine , research misconduct is historically associated with laboratory or pharmaceutical research , but the vulnerability of epidemiological surveys should be recognized .


As these surveys underpin health policy and allocation of limited resources , misreporting can have far-reaching implications .


We report how fraud in a nationwide headache survey occurred and how it was discovered and rectified before it could cause harm .


The context was a door-to-door survey to estimate the prevalence and burden of headache disorders in Pakistan .


Data were collected from all four provinces of Pakistan by non-medical interviewers and collated centrally .


Measures to ensure data integrity were preventative , detective and corrective .


We carefully selected and trained the interviewers , set rules of conduct and gave specific warnings regarding the consequences of falsification .


We employed two-fold fraud detection methods : comparative data analysis , and face-to-face re-contact with randomly selected participants .


When fabrication was detected , data shown to be unreliable were replaced by repeating the survey in new samples according to the original protocol .


Comparative analysis of datasets from the regions revealed unfeasible prevalences and gender ratios in one ( Multan ) .


Data fabrication was suspected .


During a surprise-visit to Multan , of a random sample of addresses selected for verification , all but one had been falsely reported .


The data ( from 840 cases ) were discarded , and the survey repeated with new interviewers .


The new sample of 800 cases was demographically and diagnostically consistent with other regions .


Fraud in community-based surveys is seldom reported , but no less likely to occur than in other fields of medical research .


Measures should be put in place to prevent , detect and , where necessary , correct it .


In this instance , had the data from Multan been pooled with those from other regions before analysis , a damaging fraud might have escaped notice .


Access to effective smoking cessation programs is crucial to reducing smoking-related morbidity and mortality .


Several studies have shown promising results for the application of Acceptance and Commitment Therapy ( ACT ) in managing psychological or behavioral health problems .


However , to date , only one study has examined the feasibility of a telephone-based ACT for smoking cessation and it was conducted among a Western population , in the United States .


This study reports a protocol for a randomized controlled trial ( RCT ) examining the feasibility and potential efficacy of an individual , telephone-delivered ACT for smoking cessation in primary healthcare settings among a Chinese population .


A randomized , two-group design was chosen , with assessment at baseline ( before intervention ) and via telephone follow-ups at three and six months .


Subjects will be proactively recruited from primary healthcare centers .


Eligible participants will be randomized to either the intervention ( ACT ) or control group following the baseline assessment .


Both groups will receive self-help materials on smoking cessation .


Those in the ACT group will undergo an initial face-to-face session and two telephone ACT sessions at one week and one month following the first session , to be delivered by a counselor based on the treatment protocol .


All of the participants will be contacted by telephone for follow-up assessments at three and six months .


Treatment fidelity will be assessed by reviewing around one-fifth of audio-recorded telephone calls .


To the best of our knowledge , this protocol describes the first RCT of a telephone-based ACT for smoking cessation .


It is also the first RCT of ACT for smoking cessation on a Chinese population .


The study will provide us with information about the feasibility of a telephone-delivered ACT within a Chinese sample .


If effective , this trial will support the development of ACT treatment protocols that could be made available for use by a greater range of clinicians , and offer an evidence base to support alternative treatments for smoking cessation .


ClinicalTrials.gov ID NCT01652508 .


Registered on 26 ( th ) July 2012 .


In this phase 3 extension study , the long-term maintenance of efficacy of lisdexamfetamine dimesylate ( LDX ) in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) was evaluated using a randomized-withdrawal study design .


European and US patients ( 6-17 years ; N = 276 ) with ADHD were entered into a 26-week open-label trial of LDX treatment .


Those who completed the open-label period ( n = 157 ) were randomized 1:1 to their optimized dose of LDX ( 30 , 50 , or 70 mg per day ) or placebo for a 6-week randomized-withdrawal period ( RWP ) .


The primary efficacy measure was the proportion of patients meeting treatment failure criteria ( 50 % increase in ADHD Rating Scale IV total score and 2-point increase in Clinical Global Impressions-Severity of Illness [ CGI-S ] score , compared with RWP start point ) .


Safety and tolerability were also evaluated .


During the RWP ( LDX , n = 78 ; placebo , n = 79 ) , significantly fewer patients receiving LDX met treatment failure criteria ( 15.8 % ) compared with those receiving placebo ( 67.5 % ; difference = -51.7 % ; 95 % confidence interval = -65.0 , -38.5 ; p < .001 ) .


Most treatment failures occurred at or before the week 2 visit after randomization .


Treatment-emergent adverse events were reported in 39.7 % and 25.3 % of patients receiving LDX and placebo , respectively , during the RWP .


These data demonstrate the maintenance of efficacy of LDX during long-term treatment in children and adolescents with ADHD .


The rapid return of symptoms on LDX withdrawal demonstrates the need for continuing treatment .


The safety profile of LDX was consistent with that of other stimulants .


Clinical trial registration information-Double-Blind , Placebo-Controlled , Randomized Withdrawal , Extension , Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17 ; http://clinicaltrials.gov; NCT00784654 .


To compare the utilization of conventional treatments and utilization of complementary and alternative medicine in preschoolers with autism spectrum disorders ( ASD ) and other developmental disabilities ( DD ) .


Participants were 578 children who were part of an ongoing population-based , case-control study of 2 - to 5-year olds with ASD , DD , and the general population .


Parents completed an interview on past and current services .


Four hundred fifty-three children with ASD and 125 DD children were included .


ASD families received more hours of conventional services compared with DD families ( 17.8 vs 11 ; p < .001 ) .


The use of psychotropic medications was low in both groups ( approximately 3 % ) .


Overall , complementary and alternative medicine ( CAM ) use was not significantly different in ASD ( 39 % ) versus DD ( 30 % ) .


Hispanic families in both groups used CAM less often than non-Hispanic families .


Variables such as level of function , immunization status , and the presence of an identified neurogenetic disorder were not predictive of CAM use .


A higher level of parental education was associated with an increased CAM use in ASD and DD .


Families who used > 20 hours per week of conventional services were more likely to use CAM , including potentially unsafe or disproven CAM .


Underimmunized children were marginally more likely to use CAM but not more likely to have received potentially unsafe or disproven CAM .


Use of CAM is common in families of young children with neurodevelopmental disorders , and it is predicted by higher parental education and non-Hispanic ethnicity but not developmental characteristics .


Further research should address how health care providers can support families in making decisions about CAM use .


There is no established psychometric instrument dedicated to the measurement of severity in psychotic depression ( PD ) .


The aim of this study was to investigate whether a new composite rating scale , the Psychotic Depression Assessment Scale ( PDAS ) , covering both the psychotic and the depressive domains of PD , could detect differences in effect between two psychopharmacological treatment regimens .


We reanalyzed the data from the Study of Pharmacotherapy of Psychotic Depression ( STOP-PD ) , which compared the effect of Olanzapine + Sertraline ( n = 129 ) versus Olanzapine + Placebo ( n = 130 ) .


The response to the two regimens was compared using both a mixed effects model and effect size statistics on the total scores of three rating scales : the 17-item Hamilton Depression Rating Scale ( HAM-D17 ) , its 6-item melancholia subscale ( HAM-D6 ) , and the 11-item PDAS consisting of the HAM-D6 plus five items from the Brief Psychiatric Rating Scale covering psychotic symptoms .


According to both statistical approaches , the PDAS , the HAM-D17 and the HAM-D6 were all able to detect significant differences in treatment effect between Olanzapine + Sertraline and Olanzapine + Placebo ( Olanzapine + Sertraline being superior ) .


Notably , 45 % of the trial participants were at least `` probable psychotic '' at their last assessment in the trial .


The STOP-PD was not designed specifically to answer the research questions of the present study .


The Psychotic Depression Assessment Scale ( PDAS ) is a sensitive measure of treatment response in PD .


The fact that 45 % of the patients still experienced psychotic symptoms at their last trial assessment emphasizes the need to include items pertaining to psychotic symptoms in rating scales for PD .


This study examined the effects of three consecutive days of attentional training on the salivary alpha amylase ( sAA ) , cortisol , and mood response to the Trier Social Stress Test ( TSST ) .


The training was designed to elicit faster disengagement of attention away from threatening facial expressions and faster shifts of attention toward positive ones .


Fifty-six healthy participants between the ages of 18 and 30 participated in a double-blind , within-subject experiment .


Participants were randomly assigned to one of three attentional training conditions - supraliminal training : pictures shown with full conscious awareness , masked training : stimuli presented with limited conscious awareness , or control training : both supraliminal and masked pictures shown but no shifting of attention required .


Following training , participants underwent the TSST .


Self-reported mood and saliva samples were collected for the determination of emotional reactivity , cortisol , and sAA in response to stress post-training .


Unexpectedly , participants in both attentional training groups exhibited a higher salivary cortisol response to the TSST relative to participants who underwent the control training , F ( 4 , 86 ) = 4.07 , p = .005 , p ( 2 ) = .16 .


Supraliminal training was also associated with enhanced sAA reactivity , F ( 2 , 44 ) = 13.90 , p = .000 , p ( 2 ) = .38 , and a more hostile mood response ( p = .021 ) , to the TSST .


Interestingly , the effect of attention training on the cortisol response to stress was more robust in those with high attentional control than those with low attentional control ( = -0.134 ; t = -2.24 , p = .03 ) .


This is among the first experimental manipulations to demonstrate that attentional training can elicit a paradoxical increase in three different markers of stress reactivity .


These findings suggest that attentional training , in certain individuals , can have iatrogenic effects .


The PACT randomised-controlled trial evaluated a parent-mediated communication-focused treatment for children with autism , intended to reduce symptom severity as measured by a modified Autism Diagnostic Observation Schedule-Generic ( ADOS-G ) algorithm score .


The therapy targeted parental behaviour , with no direct interaction between therapist and child .


While nonsignificant group differences were found on ADOS-G score , significant group differences were found for both parent and child intermediate outcomes .


This study aimed to better understand the mechanism by which the PACT treatment influenced changes in child behaviour though the targeted parent behaviour .


Mediation analysis was used to assess the direct and indirect effects of treatment via parent behaviour on child behaviour and via child behaviour on ADOS-G score .


Alternative mediation was explored to study whether the treatment effect acted as hypothesised or via another plausible pathway .


Mediation models typically assume no unobserved confounding between mediator and outcome and no measurement error in the mediator .


We show how to better exploit the information often available within a trial to begin to address these issues , examining scope for instrumental variable and measurement error models .


Estimates of mediation changed substantially when account was taken of the confounder effects of the baseline value of the mediator and of measurement error .


Our best estimates that accounted for both suggested that the treatment effect on the ADOS-G score was very substantially mediated by parent synchrony and child initiations .


The results highlighted the value of repeated measurement of mediators during trials .


The theoretical model underlying the PACT treatment was supported .


However , the substantial fall-off in treatment effect highlighted both the need for additional data and for additional target behaviours for therapy .


Medical textbooks often list Legionnaires ' disease as a differential diagnosis of the syndrome of inappropriate secretion of anti-diuretic hormone ( ADH ) ( SIADH ) , but evidence supporting this association is largely lacking .


We tested the hypothesis whether hyponatremia in patients with Legionnaires ' disease would be caused by increased CT-ProVasopressin .


We measured CT-ProVasopressin and sodium levels in a prospective cohort of 873 pneumonia patients from a previous multicentre study with 27 patients having positive antigen tests for Legionella pneumophila .


Patients with Legionnaires ' disease more frequently had low sodium levels ( Na < 130mmol/L ) ( 44.4 % vs 8.2 % , p < 0.01 ) , but similar mean CT-ProVasopressin levels ( pmol/l ) ( 39.4 [ 7 ] vs 51.2 [ 2.7 ] , p = 0.43 ) as compared to patients with pneumonia of other etiologies .


In patients with Legionnaires ' disease , CT-ProVasopressin levels showed a positive correlation with sodium ( r = 0.42 , p < 0.05 ) .


Independent of pneumonia etiology , CT-ProVasopressin correlated significantly with the pneumonia severity index ( r = 0.56 , p < 0.05 ) , ICU admission ( adjusted odds ratio per decile , 95 % CI ) ( 1.6 , 1.2 - 2.0 ) , and 30-day-mortality ( 1.8 , 1.3 - 2.4 ) .


While Legionnaires ' disease was associated with hyponatremia , no concurrent increase in CT-ProVasopressin levels was found , which argues against elevated ADH levels as the causal pathway to hyponatremia .


Rather , Vasopressin precursors were upregulated as response to stress in severe disease , which seems to overrule the osmoregulatory regulation of ADH .


Follicular fluid of mature oocytes is rich in growth factors and cytokines that may exert paracrine and autocrine effects on implantation .


The aim of this study was to investigate if flushing the endometrial cavity with follicular fluid after oocyte retrieval improved pregnancy rates in subfertile women undergoing intracytoplasmic sperm injection ( ICSI ) .


One hundred subfertile women undergoing ICSI between April 2012 and September 2012 at the centre for reproductive medicine , Cairo University , Egypt were enrolled in this open label , parallel randomized controlled study .


Patients were randomized into two groups at the start of treatment using a computer-generated programme and sealed opaque envelopes : the follicular fluid group ( n = 50 ) and the control group ( n = 50 ) .


Inclusion criteria were : age 20-38 years ; basal follicle-stimulating hormone < 10mIU/ml ; body mass index < 35kg/m ( 2 ) ; and ostradiol > 1000pg/ml and < 4000pg/ml on the day of human chorionic gonadotrophin administration .


Exclusion criteria were : evidence of endometriosis ; uterine myoma ; hydrosalpinges ; endocrinological disorders ; history of implantation failure in previous in-vitro fertilization/ICSI cycles ; and severe male factor infertility .


Clinical pregnancy and implantation rates were higher in the follicular fluid group compared with the control group [ 354 % ( 17/48 ) vs 319 % ( 15/47 ) ; p = 0718 ] and ( 18.6 % vs 11.3 % ; p = 0.153 ) , respectively .


However , the difference was not statistically significant .


Flushing the endometrial cavity with follicular fluid after oocyte retrieval neither improved nor adversely affected clinical pregnancy and implantation rates in subfertile women undergoing ICSI .


RCT-18 is a novel recombinant fusion protein that targets and neutralizes B-lymphocyte stimulator ( BLyS ) and a proliferation-inducing ligand ( APRIL ) .


This first in-human study investigated the safety , tolerability , pharmacokinetics , immunogenicity , and pharmacodynamics of RCT-18 in patients with rheumatoid arthritis ( RA ) .


This was a single-center , randomized , single-blind , placebo-controlled study in 28 RA patients .


Eligible patients were randomized 3:1 to receive single subcutaneous doses of RCT-18 ( 1.2 , 6 , 18 , 60 , 180 , 360 , 540mg ) or placebo .


A 71-day observation period was scheduled for each patient , during which serial blood sampling for pharmacokinetic , pharmacodynamic , and immunogenicity assessments was performed .


Safety was assessed throughout the study .


RCT-18 was well tolerated , although mild infections and skin irritation occurred more frequently in patients receiving this drug .


After single-dose RCT-18 , the maximal serum concentration ( C max ) of total and free RCT-18 was reached within 1-2days , followed by a multi-exponential decline .


Mean elimination half-life for total RCT-18 and free RCT-18 was 5.7-12 .8 days and 3.2-11 .3 days at 6-60mg , and 15.1-17 .5 days and 18.8-36 .8 days with 180-540mg RCT-18 .


The formation and elimination of BLyS-RCT-18 complex were much slower , with a time to C max of 5-29days and the elimination half-life mounting from 13.3 to 32.8 days with dose escalation .


No positive reaction was detected in the immunogenicity assessments .


Substantial IgM reduction was only evidenced with 540mg RCT-18 , while the response profiles of IgM/IgG were distinguishable from placebo after 180 , 360 , or 540mg RCT-18 .


RCT-18 was safe and well tolerated up to 540-mg single doses .


The serum exposure of total and free RCT-18 is linearly correlated to the weight-normalized doses of RCT-18 in dose groups receiving 180-540mg RCT-18 .


The elimination half-life of BLyS-RCT-18 increased with RCT-18 doses , suggesting a shift from target-mediated disposition in 1.2-18mg RCT-18 groups to non-specific clearance in 60-540mg RCT-18 groups .


Assuming the concentration of BLyS-RCT-18 complex and the IgM/IgG ratio are surrogate biomarkers for clinical effects of RCT-18 , the dose-response relationship suggests 180-540mg are pharmacodynamically effective doses in RCT-18 for RA patients , but the effect profile of 540mg RCT-18 on IgM is similar to that of atacicept at pharmacodynamically effective but clinically ineffective doses .


Dairy protein seems to reduce appetite by increasing satiety and delaying the return of hunger and subsequently lowering energy intake compared with fat or carbohydrate .


The aim of this study was to compare the effect of whey with that of casein proteins on satiety in overweight/obese individuals .


This was a randomized , parallel-design 12-week-long study .


Seventy subjects with a body mass index between 25 and 40kg/m ( 2 ) and aged 18-65 years were randomized into one of three supplement groups : glucose control ( n = 25 ) , casein ( n = 20 ) or whey ( n = 25 ) protein .


Before commencing the study , at weeks 6 and 12 of the treatment , a Visual Analogue Scale ( VAS ) was used to measure subjective sensations of appetite before lunch and before dinner .


Rating for VAS ( mm ) at 6 and 12 weeks showed significantly higher satiety in the whey group compared with the casein ( P = 0.017 and P = 0.025 , respectively ) or control ( P = 0.024 and P = 0.032 , respectively ) groups when measured before lunch .


Similarly , at 6 and 12 weeks , the score for fullness was also significantly higher in the whey group compared with both casein ( P = 0.038 and P = 0.022 , respectively ) and control ( P = 0.020 and P = 0.030 , respectively ) groups .


However , these short-term effects on satiety from dairy whey proteins did not have any long-term effects on energy intake or body weight over 12 weeks compared with casein .


Collectively , whey protein supplementation appears to have a positive and acute postprandial effect on satiety and fullness compared with casein and carbohydrate supplementation in overweight and obese individuals .


Inhalation of diesel exhaust ( DE ) at moderate concentrations causes increased airway responsiveness in asthmatics and increased airway resistance in both healthy and asthmatic subjects , but the effect of baseline airway responsiveness and anti-oxidant supplementation on this dynamic is unknown .


We aimed to determine if changes in airway responsiveness due to DE are attenuated by thiol anti-oxidant supplementation , particularly in those with underlying airway hyper-responsiveness .


Participants took N-acetylcysteine ( 600 mg ) or placebo capsules three times daily for 6 days .


On the last of these 6 days , participants were exposed for 2 h to either filtered air ( FA ) or DE ( 300 g/m ( 3 ) of particulate matter smaller than 2.5 microns ) .


Twenty-six non-smokers were studied under each of three experimental conditions ( filtered air with placebo , diesel exhaust with placebo , and diesel exhaust with N-acetylcysteine ) using a randomized , double-blind , crossover design , with a 2-week washout between conditions .


Methacholine challenge was performed pre-exposure ( baseline airway responsiveness ) and post-exposure ( effect of exposure ) .


Anti-oxidant supplementation reduced baseline airway responsiveness in hyper-responsive individuals by 20 % ( p = 0.001 ) .


In hyper-responsive individuals , airway responsiveness increased 42 % following DE compared with FA ( p = 0.03 ) and this increase was abrogated with anti-oxidant supplementation ( diesel exhaust with N-acetylcysteine vs. filtered air with placebo , p = 0.85 ) .


Anti-oxidant ( N-acetylcysteine ) supplementation protects against increased airway responsiveness associated with DE inhalation and reduces need for supplement bronchodilators in those with baseline airway hyper-responsiveness .


Individuals with variants in genes of oxidative stress metabolism when exposed to DE are protected from increases in airway responsiveness if taking anti-oxidant supplementation .


To test the effectiveness of thymus honey as a complementary intervention for decreasing the salivary gland damage due to Radioiodine ( ( 131 ) I ) therapy .


Radioiodine is the treatment of choice in people diagnosed with thyroid cancer following total thyroidectomy .


Although its value has been acknowledged in eradicating remnant thyroid tissue and treating residual disease in patients with visible , inoperable , iodine-avid metastases , it has been associated with various salivary gland side effects .


This is a randomized controlled trial with a 2 3 mixed between-within subjects design .


In total , 120 participants of postsurgical differentiated thyroid cancer , who will be referred to this centre for ( 131 ) I therapy to ablate the remnant thyroid tissue or to treat metastatic tumour , will be prospectively studied under varying regimens of lemon candy ( standard treatment ) and thymus honey mouthwashes ( experimental intervention ) .


Patients will be randomized in four equally numbered groups based on the assumptions and hypothesis of the study .


The recruiting process will be informed by predefined inclusion and exclusion criteria .


Mixed statistical modelling will be adopted taking into consideration between and within subjects ' effects and repeated measures .


The recommended intervention protocol is expected to improve the comprehensive management of salivary gland-related side effects induced by the radioiodine treatment in people diagnosed with thyroid cancer .


Through the methodological approach chosen , the ideal intervention protocol in terms of the time to initiate the intervention and the frequency of the intervention to acquire optimal results in minimizing salivary glands damage will be tested .


This study examined the immediate effects of noxious and innocuous thermal stimulation intervention on corticomotor excitability for the paretic arm in patients with stroke .


Sixteen patients with stroke for more than 3 mos were randomly assigned into the experimental and control groups .


All participants received the thermal stimulation protocol on the affected arm for 30 mins .


The experimental group received noxious heat ( 46C-47C ) and cold ( 7C-8C ) stimuli , and the control group received innocuous heat ( 40C-41C ) and cold ( 20C-21C ) stimuli .


Corticomotor excitability was assessed to measure the motor threshold , size of cortical motor output map , and mean motor evoked potentials for the abductor pollicis brevis by focal transcranial magnetic stimulation before and after 30 mins of thermal stimulation intervention program .


The findings of transcranial magnetic stimulation revealed a significant increase in map size of the affected hemisphere and mean motor evoked potentials in the experimental group .


Moreover , significant differences in the change values of map size ( 7.0 [ 7.9 ] for the experimental group vs. -1.7 [ 2.9 ] for the control group , P = 0.03 ) and mean ( SD ) motor evoked potentials ( 0.4 [ 8.9 ] mV for the experimental group vs. -0.1 [ 0.1 ] mV for the control group , P = 0.03 ) were found .


The preliminary results suggest that the noxious 30 mins of thermal stimulation intervention induced neurophysiologic changes in the motor cortex of the lesioned hemisphere .


To evaluate the effectiveness of neuromuscular electrical stimulation ( NMES ) treatment in patients with oropharyngeal dysphagia secondary to acquired brain injury .


Twenty patients with neurological oropharyngeal dysphagia ( 14 stroke and six severe traumatic brain injury ) were enrolled in a prospective randomized study , with patients and assessors blinded ( to group allocation ) : 10 patients underwent NMES and conventional swallowing therapy and 10 patients underwent sham electrical stimulation ( SES ) and conventional swallowing therapy .


Both groups completed 20 sessions .


At baseline , at the end of treatment ( 1month ) and at 3-month follow-up , clinical , videofluoroscopic and esophageal manometric analyses were done .


Feeding swallowing capacity was evaluated using the functional oral intake scale ( FOIS ) .


Mean FOIS score before treatment was 1.9 for the NMES group and 2.1 for the SES group .


After treatment , the NMES group increased by 2.6 points ( 4.5 points ) compared with only 1 point ( 3.1 points ) for the SES group ( P = 0.005 ) .


At 3months of follow-up , mean scores were 5.3 and 4.6 respectively ; thus , both groups improved similarly .


At that time point ( 3months ) , tracheal aspiration persisted in six patients in each group .


However , a significant improvement in relation to the bolus viscosity at which aspiration appeared was found in the NMES group versus the SES group ( P = 0.015 ) .


Also , a significant increase ( P = 0.04 ) in pharyngeal amplitude contraction was observed at the end of treatment ( 1month ) in the NMES group compared with the SES group .


Neuromuscular electrical stimulation significantly accelerated swallowing function improvement in patients with oropharyngeal dysphagia secondary to acquired brain injury .


An earlier randomized controlled trial ( RCT ) study showed that bee venom acupuncture ( BVA ) in combination with physiotherapy can be more effective in functional improvement and pain reduction in patients with adhesive capsulitis ( AC ) .


The objective of the current study was to examine the long-term effect of BVA in combination with physiotherapy on AC of the shoulder .


Retrospective 1-year follow-up analysis of a previous RCT using a telephone interview method .


Outpatient joint center at the Gang Dong Kyung Hee University Hospital of Seoul , Republic of Korea .


A total of 192 patients had been enrolled in the previous study , and 124 of these were excluded from the current study .


Sixty-eight patients who had been treated with combined BVA and physiotherapy for AC of the shoulder for 2 months were interviewed at approximately 1 year after treatment by telephone .


Sixty of 68 patients were included in the follow-up analysis .


Twenty received BV 1 treatment ( 1:10,000 concentration BVA plus physiotherapy ) , 22 received BV 2 treatment ( 1:30,000 concentration BVA plus physiotherapy ) , and 18 received control treatment ( normal saline injection plus physiotherapy ) .


The primary outcome measure was Shoulder Pain And Disability Index ( SPADI ) score .


Secondary outcome measure was score on verbal rating scale for pain and patient satisfaction .


Baseline characteristics of the groups did not significantly differ .


SPADI scores at 1 year significantly differed between the BV 1 group and the control group ( p = 0.043 ) .


No significant differences were found in pain verbal rating scores after 1 year .


Treatment satisfaction with therapy was also assessed , and the BV 1 and BV 2 groups showed significantly greater satisfaction compared with the control group .


BVA combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder .


Synaptic loss is a major hallmark of Alzheimer 's disease ( AD ) .


Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication .


The medical food Souvenaid , containing the specific nutrient combination Fortasyn Connect , is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials .


To explore the effect of Souvenaid compared to control product on brain activity-based networks , as a derivative of underlying synaptic function , in patients with mild AD .


A 24-week randomised , controlled , double-blind , parallel-group , multi-country study .


179 drug-nave mild AD patients who participated in the Souvenir II study .


Patients were randomised 11 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks .


In a secondary analysis of the Souvenir II study , electroencephalography ( EEG ) brain networks were constructed and graph theory was used to quantify complex brain structure .


Local brain network connectivity ( normalised clustering coefficient gamma ) and global network integration ( normalised characteristic path length lambda ) were compared between study groups , and related to memory performance .


THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS : they decreased in the control group , but remained relatively unchanged in the active group .


No consistent relationship was found between these network measures and memory performance .


The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks , hypothetically counteracting the progressive network disruption over time in AD .


The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function .


Secondly , we conclude that advanced EEG analysis , using the mathematical framework of graph theory , is useful and feasible for assessing the effects of interventions .


Dutch Trial Register NTR1975 .


To investigate the therapeutic effect of topical corticosteroids injection and systemic application in the treatment of typing idiopathic sudden sensorineural hearing loss ( ISSNHL ) .


Total of 438 patients with ISSNHL , including 76 with hearing loss in low-middle frequencies , 43 in middle-high frequencies , 162 in all frequencies and 157 in total deafness , were randomly divided into two groups , the systemic application group : dexamethasone ( DEX ) was applied by intravenous injection in dose of 10 mg3 d followed by 5 mg4 d , and the topical injection group : methylprednisolone sodium succinate of 40 mg was injected into cortical bone of mastoid region every three days .


According to the results of pure-tone threshold audiometry , the curative effect among ISSNHL with low-middle frequencies , middle-high frequencies , all frequencies hearing loss , and total deafness were evaluated .


SPSS 18.0 software was used to analyze the data .


Among 220 patients with systemic application of DEX , 66 subjects ( 30.0 % ) cases were recovery , 51 ( 23.2 % ) were excellent better , 39 ( 17.7 % ) better , 64 ( 29.1 % ) were poor , and the total effective rate was 70.9 % ( 156/220 ) .


There was no statistical difference in total effective rate of four typing subgroups ( ( 2 ) = 1.60 , P > 0.05 ) .


And the recovery rate in total deafness subgroup was significant lower than that in low-middle and all frequencies subgroups ( ( 2 ) = 10.63 and 15.94 respectively , both P < 0.05 ) .


In the topical injection group , the recovery rate was 30.3 % ( 66 cases ) , excellent better 18.8 % ( 41 ) , better 15.6 % ( 34 ) , poor 35.3 % ( 77 ) , and the total effective rate was 64.7 % ( 141/220 ) .


There were statistical differences of total effective rate in low-middle frequencies in comparison with that in all frequencies ( ( 2 ) = 8.38 ) and total deafness ( ( 2 ) = 7.28 ) subgroups ( both P < 0.05 ) .


Regarding recovery rate , there were significant differences between each two typing subgroups , except middle-high frequencies subgroup vs. all frequencies ( ( 2 ) = 1.60 ) and total deafness ( ( 2 ) = 2.29 ) subgroups ( both P < 0.05 ) .


In 76 ISSNHL with hearing loss in low-middle frequencies , the recovery rate in cases with local corticosteroids injection ( 65.0 % ) was significantly increased in comparison with that with systemic application ( 41.7 % ) , ( 2 ) = 4.15 , P < 0.05 .


There were increasing tendencies of curative effect in other three typing groups by systemic corticosteroids application when compared with local injection , but no statistical significances ( all P > 0.05 ) .


For low-middle frequencies ISSNHL , the corticosteroids administration of local injection should be the optimization .


Systemic application would be applied for middle-high frequencies , all frequencies and total deafness .


The present study investigated the efficacy of a 6-hour self-directed workbook adapted from the REACH Forgiveness intervention .


Undergraduates ( N = 41 ) were randomly assigned to either an immediate treatment or waitlist control condition .


Participants were assessed across 3 time periods using a variety of forgiveness outcome measures .


The 6-hour workbook intervention increased forgiveness , as indicated by positive changes in participants ' forgiveness ratings that differed by condition .


In addition , benchmarking analysis showed that the self-directed workbook intervention is at least as efficacious as the delivery of the REACH Forgiveness model via group therapy .


A self-directed workbook intervention adapted from the REACH Forgiveness intervention provides an adjunct to traditional psychotherapy that could assist the mental health community to manage the burden of unforgiveness among victims of interpersonal harm .


Although renal sinus fat invasion has prognostic significance in patients with renal cell carcinomas ( RCCs ) , there are no previous studies about the value of multidetector computed tomography ( MDCT ) about this issue in the current literature .


A total of 863 consecutive patients ( renal sinus fat invasion in 110 patients ( 12.7 % ) ) from single institutions with surgically-confirmed renal cell carcinoma who underwent MDCT between 2010 and 2012 were included in this study .


The area under the curves ( AUCs ) of the receiver operating characteristic ( ROC ) analysis was used to compare diagnostic performance .


Reference standard was pathologic examination .


Weighted statistics were used to measure the level of interobserver agreement .


Multivariate logistic regression model was used to find the predictors for renal sinus fat invasion .


Image analysis was first performed with axial-only CT images .


A second analysis was then performed with both axial and coronal CT images .


A qualitative analysis was then conducted by two reviewers who reached consensus regarding tumor size , decreased perfusion , tumor margin , vessel displacement , and lymph node metastasis .


The reference standard was pathologic evaluation .


The AUCs of the ROC analysis were 0.881 and 0.922 for axial-only images and 0.889 and 0.902 for combined images in both readers .


The AUC of tumor size was 0.884 , a similar value to that of the reviewers .


In multivariate analysis , tumor size , a linear-nodular or nodular type of fat infiltration , and an irregular tumor margin were independent predicting factors for perinephric fat invasion .


MDCT shows relatively high diagnostic performance in detecting perinephric fat invasion of RCC but suffers from a relatively low PPV related to low prevalence of renal sinus fat invasion .


Applying tumor size alone we could get similar diagnostic performance to those of radiologists .


Tumor size , fat infiltration with a nodular appearance , and an irregular tumor margin were predictors for perinephric invasion .


Quality of life ( QOL ) of patients receiving home parenteral nutrition ( HPN ) may be impacted by device technology .


Historically , our HPN patients used pole-mounted pumps which can hinder activities and affect QOL .


Patients receiving HPN with a pole-mounted pump completed Short Form 36 ( SF-36 ) and pump-specific questionnaires .


Patients were then enrolled in a 2-month prospective crossover open study .


Patients were randomized to use a pole-mounted pump or a portable pump .


After 1 month , each arm crossed over .


Measurements were repeated at 4 and 8 weeks .


Participants included 5 males , 15 females ; age 52.8 3.3 ( mean SEM ) years ; 50 % had short bowel syndrome ; received HPN for 83.3 15.9 months ; infused HPN over 11.2 0.3 hours/day ; 4.3 0.4 days/week .


Portable pump users scored 53.75 5.64 , 61.25 6.14 , and 40.31 4.94 in SF-36v2 physical , social , and health vitality , respectively , while the stationary pump users scored 45.50 4.82 , 55.00 5.97 , and 35.31 4.63 , respectively ( NS ) .


They reported ease of movement between rooms ( 4.11 0.21 vs 1.44 0.20 ; P = .001 ) ; when traveling ( 5.00 0.00 vs 3.00 0.45 ; P < .02 ) ( 1 = very difficult , 5 = very easy ) ; 5.0 % were sleep disturbed with the portable compared to 42.1 % with pole-mounted pump ( P < .04 ) .


Overall , patients were significantly happier with the portable vs pole-mounted pump ( 4.53 0.19 vs 2.68 0.22 ; P < .001 ) ( 1 = very unhappy , 5 = very happy ) .


Our HPN patients reported improved happiness and satisfaction regarding ease of use and function with a portable vs pole-mounted pump .


We aimed to evaluate the surrogacy of bone mineral density and bone turnover markers for incident vertebral fracture using data from 237 patients treated with once weekly 56.5 g teriparatide or placebo .


This analysis was conducted using data from the Teriparatide Once-Weekly Efficacy Research trial , a randomized , double-blind , placebo-controlled trial for patients with severe osteoporosis in Japan .


A total of 237 subjects ( placebo group , n = 130 ; teriparatide group , n = 107 ) were assessed at baseline and at 72 weeks .


Main outcome measures included estimation of the treatment effects of once weekly teriparatide on vertebral fracture risk reduction using percentage changes in lumbar bone mineral density and bone turnover markers .


The percentage change in lumbar bone mineral density was 6.69 % in the teriparatide group compared with 0.28 % in the placebo group ( p < 0.01 ) .


One incident vertebral fracture occurred in the teriparatide group compared with 16 in the placebo group .


The unadjusted and adjusted hazard ratios of the teriparatide group compared with the placebo group were 0.07 ( 95 % confidence interval : 0.01 to 0.56 ) and 0.64 ( 95 % confidence interval : 0.06 to 6.36 ) , respectively .


The proportion of treatment effect explained by changes in lumbar bone mineral density was 83 % ( Freedman 's method ) and 66 % ( Chen 's method ) .


There were no notable changes in hazard ratios if we adjusted for bone turnover markers .


Most of the vertebral fracture risk reduction with once weekly 56.5 g teriparatide is explained by changes in lumbar bone mineral density rather than changes in bone turnover markers .


Poor sleep hygiene including sleeping in the daytime or with the lights on at night is discovered during the assessment of many sleep disorders including sleep apnea .


The aim of this study was to investigate whether environmental light affected autonomic control of heart rate , sleep-disordered breathing ( SDB ) , and/or breathing patterning .


Seventeen non-obese healthy volunteers without witnessed snoring and apneas were recruited .


Studies were performed at home using a type 3 portable monitor combined with actigraphy for sleep-wake timing , using a randomly assigned , crossover between dark , or 1,000 lx of fluorescent lighting environment .


The outcomes were low-frequency power divided by high-frequency power ( LF/HF ratio ) in the analysis of heart rate variability , the apnea-hypopnea index ( AHI ) , and ventilatory pattern variability before and after sleep onset between environments .


The LF/HF ratio and AHI were both significantly higher in light as compared to dark .


Before sleep onset , the coefficient of variation ( CV ) for breath-to-breath tidal volume representing breathing irregularity tended to be higher in light than in dark environment .


The CV values for tidal volume after sleep onset were significantly decreased compared with before sleep onset in both sleep environments .


Mutual information of the ventilatory pattern was significantly lower before sleep onset than after sleep onset , only in the light environment .


Sleeping in the light has effects like that of a stressor as it is associated with neuroexcitation , SDB , and resting breathing irregularity in healthy volunteers .


These findings may be relevant to many sleep disorders associated with poor sleep hygiene .


Despite evidence that daily self-weighing is an effective strategy for weight control , concerns remain regarding the potential for negative psychological consequences .


The goal of the study was to examine the impact of a daily self-weighing weight-loss intervention on relevant psychological constructs .


A 6-month RCT .


The study sample ( N = 91 ) included overweight men and women in the Chapel Hill NC area .


Between February and August 2011 , participants were randomly assigned to a daily self-weighing intervention or delayed-intervention control group .


The 6-month intervention included daily self-weighing for self-regulation of diet and exercise behaviors using an e-scale that transmitted weights to a study website .


Weekly e-mailed lessons and tailored feedback on daily self-weighing adherence and weight-loss progress were provided .


Self-weighing frequency was measured throughout the study using e-scales .


Weight was measured in-clinic at baseline , 3 months , and 6 months .


Psychological outcomes were assessed via self-report at the same time points .


In 2012 , using linear mixed models and generalized estimating equation models , there were no significant differences between groups in depressive symptoms , anorectic cognitions , disinhibition , susceptibility to hunger , and binge eating .


At 6 months , there was a significant group X time interaction for body dissatisfaction ( p = 0.007 ) and dietary restraint ( p < 0.001 ) , with the intervention group reporting lower body dissatisfaction and greater dietary restraint compared to controls .


Results indicate that a weight-loss intervention that focuses on daily self-weighing does not cause adverse psychological outcomes .


This suggests that daily self-weighing is an effective and safe weight-control strategy among overweight adults attempting to lose weight .


This study is registered at clinicaltrials.gov NCT01369004 .


Depression is a mental health condition which affects millions of people each year , with worldwide rates increasing .


Cognitive behavioral therapy ( CBT ) is recommended in the National Institute for Health and Clinical Excellence ( NICE ) guidelines for the treatment of depression .


However , waiting lists can cause delays for face-to-face therapy .


Also a proportion of people decline to present for help through the health service - the so-called treatment gap .


Self-referral to CBT using community-based group interventions delivered by a voluntary sector organization may serve to resolve this problem .


The aim of this randomized controlled trial ( RCT ) is to determine the efficacy of such a guided CBT self-help course , the ` Living Life to the Full ' ( LLTTF ) classes delivered by the charity Action on Depression ( AOD ) .


The primary outcome is level of depression at 6 months assessed using the patient health questionnaire-9 ( PHQ9 ) depression scale .