Patients were assigned to groups , given a combination of MARS and standard medical therapy ( SMT ) ( MARS-group , n = 9 ) or Prometheus and SMT ( Prometheus-group , n = 17 ) .


Inclusion criteria were clinical and laboratory signs of ALF : serum total bilirubin level > 180 mkmol/L , 2-fold increasing serum aspartate aminotransferase ( AST ) and alanine aminotransferase ( ALT ) , low serum cholinesterase and high serum ammonia levels .


A variety of clinical and biochemical parameters were assessed .


Primary endpoint was survival probabilities at day 28 .


MARS was used to provide 1 to 2 rounds ( minimum of 6 hours each ) and Prometheus was used to provide 2 to 14 rounds ( minimum of 6 hours each ) .


There were amelioration of haemodinamic instability , especially in MARS-group ( increase in ADmean was 17 % in MARS ( p = 0.005 ) and 10 % in Prometheus-group ( p = 0.001 ) ) , increase in P/F ratio ( 12 % in Prometheus-group ( p = 0.07 ) ) , decrease in serum total bilirubin ( 8.6 % in MARS-group ( p = 0.028 ) and 33 % in Prometheus-group ( p < 0.001 ) ) and unconjugated bilirubin levels ( 29 % in Prometheus-group ( p = 0.003 ) ) , also we had decreasing in serum aminotransferase levels and trend to increasing in serum cholinesterase level ( 12 % in MARS-group ( p = 0.87 ) and 8 % in Prometheus-group ( p = 0.86 ) ) .


There were no side effects of extracorporeal liver support in both patients groups .


Survival of patients with ALF , treated with MARS was 22 % , in Prometheus group -- 35 % .


MARS and Prometheus are found to be safe and effective in patients with ALF after cardiac surgery .


Further studies are needed to assess whether therapy might be beneficial in specific sublets of patients .


To compare the effects of different arm positions on dose exposure and image quality ( IQ ) in cervical spine CT after trauma in different patient groups .


Patients in standard ( STD = 126 ) and in swimmer 's position ( SWIM = 254 ) were included .


Body mass index ( BMI subgroup 1 = underweight to subgroup 4 = obese ) , anterior-posterior diameter ( AP ) , left-right diameter ( LR ) , area of an ellipse ( AoE ) and angle between the humeral heads ( optimal STD < 3 , optimal SWIM > 10 ) were used as grouping criteria .


Computed tomography dose index ( CTDI ) was documented .


Two radiologists rated the IQ at three levels ( CV1/2 , CV4/5 , CV7/T1 ) using a semi-quantitative scale ( 0 = not diagnostic , 1 = diagnostic with limitations , 2 = diagnostic without limitations ) .


The Mann-Whitney U test correlations of grouping criteria with dose effects and intra-class correlation ( ICC ) were calculated .


ICC was 0.87 .


BMI grouping showed the strongest correlation with dose effects : CTDI of optimal STD versus optimal SWIM positioning was 3.17 mGy versus 2.46 mGy ( subgroup 1 ) , 5.47 mGy versus 3.97 mGy ( subgroup 2 ) , 7.35 mGy versus 5.96 mGy ( subgroup 3 ) and 8.71 mGy versus 8.18 mGy ( subgroup 4 ) .


Mean IQ at CV7/T1 was 1.65 versus 1.23 ( subgroup 1 ) , 1.27 versus 1.46 ( subgroup 2 ) , 1.06 versus 1.46 ( subgroup 3 ) , 0.79 versus 1.5 ( subgroup 4 ) .


Patients with a BMI > 20 kg/m ( 2 ) benefited from both potential dose reduction and improved image quality at the critical cervicothoracic junction when swimmer 's position was used .


BMI is a useful metric for personalized optimization in CT for the c-spine .


Using swimmer 's position , patients can benefit from dose reduction .


In some patients a superior image quality can be achieved with swimmer 's position .


For swimmer 's positioning an angle of more than 10 is optimal .


To study the mechanism of Dan ' e Fukang Soft Extract ( DFSE ) on improving oocyte and embryo qualities in endometriosis patients undergoing in vitro fertilization-embryo transfer ( IVF-ET ) .


Totally 70 patients with endometriosis confirmed by laparoscope were randomly assigned to two groups , the treated group and the control group , 35 cases in each group .


Patients in the treated group were treated with DFSE + controlled ovarian hyperstimulation ( COH ) , while those in the control group were treated with DFSE placebo + COH .


Besides , recruited were another 35 subjects undergoing intracytoplasmic sperm injection-embryo transfer ( ICSI-ET ) as a normal control group .


The content of growth differentiation factor 9 ( GDF-9 ) in the granulocytes of the mature follicular fluid on the oocyte retrieval day was determined by Western blot .


The mRNA expression of GDF-9 was detected by RT-PCR .


The oocyte retrieval number , the cleavage rate , the fertilization rate , the high-quality embryo rate , and the pregnancy rate were compared .


The mRNA expression of GDF-9 in the granulocytes was significantly higher in the treated group than in the control group , showing statistical difference ( P < 0.05 ) , but with no statistical difference when compared with that of the normal control group .


There was no statistical difference in the cleavage rate between the two groups ( P > 0.05 ) .


The fertilization rate and the high-quality embryo rate were higher in the treated group than in the control group , showing statistical difference ( P < 0.05 ) , but with no statistical difference when compared with that of the normal control group .


DFSE could improve the oocyte and embryo qualities of endometriosis patients undergoing IVF-ET .


Its mechanism might be associated with regulating the GDF-9 mRNA level of granulocytes .


To study the efficacy/safety of apremilast , an oral phosphodiesterase 4 inhibitor , compared with placebo in patients with active rheumatoid arthritis ( RA ) who had an inadequate response to methotrexate ( MTX ) .


Patients were randomized 1:1:1 to receive placebo , apremilast 20 mg twice a day , or apremilast 30 mg twice a day .


Patients whose swollen and tender joint counts had not improved by 20 % were considered nonresponders at week 16 and were required to enter the protocol-defined early escape .


At week 24 , patients were transitioned in a blinded manner to receive apremilast 20 mg twice a day if they were initially randomized to receive placebo .


Patients who were not initially randomized to receive placebo continued to receive their target apremilast dose .


Patients were required to take a stable dose of MTX ( 7.5-25 mg/week ) throughout the study .


Magnetic resonance imaging ( MRI ) was performed in a subset of patients .


A total of 237 patients who were receiving MTX therapy were randomized and received 1 dose of study medication .


At week 16 , similar proportions of patients receiving placebo ( 35 % ) , apremilast 20 mg twice a day ( 28 % ) , and apremilast 30 mg twice a day ( 34 % ) met the American College of Rheumatology criteria for 20 % improvement in disease activity ( the primary efficacy end point ) .


In the MRI substudy , mean change from baseline in total joint damage scores according to the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring system was generally similar with either apremilast dose at week 16 .


At week 52 , no trends were noted for clinical end points by treatment group .


Both apremilast doses were generally well tolerated .


Apremilast efficacy was not demonstrated in patients who had active RA despite stable MTX therapy .


Each year , approximately 11 % of women diagnosed with breast cancer in the United States are 45 years of age or younger .


These women have concerns specific to or accentuated by their age , including fertility-related concerns , and have higher rates of psychosocial distress than women diagnosed at older ages .


Current guidelines recommend that fertility risks be considered early in all treatment plans ; however , the extant research indicates that attention to fertility by the healthcare team is limited .


Importantly , attention to fertility may be a proxy for whether or not other important issues warranting attention in younger women with breast cancer are addressed , including genetic risks , psychosocial distress , sexual functioning , and body image concerns .


The Young & Strong study tests the efficacy of an intervention designed for young women recently diagnosed with breast cancer and their oncologists with the intention to : 1 ) increase attention to fertility as an important surrogate for other issues facing young women , 2 ) educate and support young women and their providers , and 3 ) reduce psychosocial distress among young women with breast cancer .


The study employs a cluster randomized design including 14 academic institutions and 40 community sites across the U.S. assigned to either the study intervention arm or contact-time comparison intervention arm .


Academic institutions enroll up to 15 patients per site while community sites enroll up to 10 patients .


Patient eligibility requirements include : an initial diagnosis of stage I-III invasive breast cancer within three months prior , without a known recurrence or metastatic breast cancer ; 18-45 years of age at diagnosis ; ability to read and write in English .


The primary outcome is oncologists ' attention to fertility concerns as determined by medical record review .


Secondary outcomes include differences in patient satisfaction with care and psychosocial distress between the two study arms .


Study findings will provide valuable insight into how to increase attention to fertility and other issues specific to young women with breast cancer and how to improve doctor-patient communication around these issues , which may promote better quality of care for this population .


NCT01647607 .


Registered July 19 , 2012 .


To evaluate the clinical efficiency , tolerance , and pharmacoeconomic parameters of treatment for mild community-acquired pneumonia ( CAP ) in patients with risk factors for ineffective treatment with levofloxacin ( Glevo ) versus original levofloxacin and standard pharmacotherapy regimens for mild pneumonia ( real practice ) .


An open-label comparative randomized trial was conducted in parallel groups of 147 patients aged > or = 18 years with mild CAP and risk factors for ineffective treatment .


Group 1 included 61 patients ( 59 men and 2 women ; mean age 23.3 + / - 11.2 years ) receiving levofloxacin ( Glevo ) 500 mg/day ; Group 2 comprised 41 patients ( 39 men and 1 woman ; mean age 26.4 + / - 13.4 years ) treated with original levofloxacin 500 mg/day ; Group 3 consisted of 45 patients ( all men ; mean age 23.7 + / - 9.9 years ) on standard therapy .


The trial was performed in 3 pulmonology centers .


The use of the respiratory fluoroquinolone levofloxacinto treat mild CAP in the patients with risk factors for failure for its therapy demonstrated a higher efficiency than the antibiotic regimens used in real clinical practice .


This suggests that physicians underestimate risk factors and do not always make a rational choice of an antimicrobial agent in the given clinical situation .


The generic form of levofloxacin ( Glevo ) is as clinically effective as its original drug in the treatment of CAP and characterized by its optimal pharmacoeconomic parameters .


Abaloparatide is a novel synthetic peptide analog of parathyroid hormone-related protein ( PTHrP ) that is currently being developed as a potential anabolic agent in the treatment of postmenopausal osteoporosis .


This study sought to assess the effects of abaloparatide on bone mineral density ( BMD ) at the lumbar spine , total hip , and femoral neck in postmenopausal women with osteoporosis .


Multi-center , multi-national , double-blind placebo controlled trial in which postmenopausal women were randomly assigned to receive 24 weeks of treatment with daily sc injections of placebo , abaloparatide , 20 , 40 , or 80 g , or teriparatide , 20 g.


A 24-week extension was also performed in a subset of subjects .


Postmenopausal women with osteoporosis ( n = 222 ) .


BMD by dual-x-ray absorptiometry and biochemical markers of bone turnover .


At 24 weeks , lumbar spine BMD increased by 2.9 , 5.2 , and 6.7 % in the abaloparatide , 20 - , 40 - , and 80-g groups , respectively , and 5.5 % in the teriparatide group .


The increases in the 40 - and 80-g abaloparatide groups and the teriparatide group were significantly greater than placebo ( 1.6 % ) .


Femoral neck BMD increased by 2.7 , 2.2 , and 3.1 % in abaloparatide , 20 - , 40 - , and 80-g groups , respectively , and 1.1 % in the teriparatide group .


The increase in femoral neck BMD with abaloparatide , 80 g was significantly greater than placebo ( 0.8 % ) .


Total hip BMD increased by 1.4 , 2.0 , and 2.6 % in the abaloparatide , 20 - , 40 - , and 80-g groups , respectively .


The total hip increases in the 40 - and 80-g abaloparatide groups were greater than both placebo ( 0.4 % ) and teriparatide ( 0.5 % ) .


Compared with placebo , 24 weeks of daily sc abaloparatide increases BMD of the lumbar spine , femoral neck , and total hip in a dose-dependent fashion .


Moreover , the abaloparatide-induced BMD increases at the total hip are greater than with the marketed dose of teriparatide .


These results support the further investigation of abaloparatide as an anabolic therapy in postmenopausal osteoporosis .


To observe the clinical effects of myopia in children treated with abdominal acupuncture .


Ninety children with myopia were randomly divided into an abdominal acupuncture group ( 45 cases with 90 ill eyes ) and an auricular point group ( 45 cases with 90 ill eyes ) .


In the abdominal acupuncture group , Zhongwan ( CV 12 ) , Shangqu ( KI 17 ) , Xiawan ( CV 10 ) , Tianshu ( ST 25 ) , Qihai ( CV 6 ) , Guanyuan ( CV 4 ) were treated with tapping method .


The needles were not retained and down to the lower in accordance with the order from Zhongwan ( CV 12 ) to Guanyuan ( CV 4 ) for 5 min , and the erubescence skin without blood was proper .


In the auricular point group , vaccaria seeds were pasted at gan ( CO12 ) , shen ( CO10 ) , pi ( CO13 ) , wei ( CO4 ) , yan ( LO5 ) , pingjianqian ( TG2i ) , pingjianhou ( ATli ) and zhen ( AT3 ) ; one ear was chosen every time and the other ear the second time with pressing of patient 's own for 5 min every day .


The treatment was given twice a week and 10 treatments were considered as one course in the two groups .


The changes of the visual levels in visual chart before treatment , 20 min after the first treatment , after 5 weeks ' and 3 months ' treatment were compared between the two groups , and the clinicall efficacy was compared between the two groups as well .


( 1 ) The visual levels in visual chart were improved in the abdominal acupuncture group and auricular point group , and the effects 20 min after the first treatment , after 5 weeks ' and 3 months ' treatment in the abdominal acupuncture group were superior to those in the auricular point group ( 4.780.16 vs 4.690.22 , P < 0.01 ; 4.850.16 vs 4.790.21 , P < 0.05 ; 4.890.13 vs 4.710.25 , P < 0.01 ) .


( 2 ) The effective rates 20 min after the first treatment , after 5 weeks ' and 3 months ' treatment in the abdominal acupuncture group were better than those in the auricular point group [ 31.4 % ( 27/86 ) vs 0 % ( 0/82 ) .


81.4 % ( 70/86 ) vs 60.0 % ( 49/82 ) ; 88.4 % ( 76/86 ) vs 51.2 % ( 42/82 ) , all P < 0.01 ] .


Abdominal acupuncture for improving the visual levels of myopia in children is superior to auricular point sticking .


To assess the impact of low concentration contrast media on the degree of vascular enhancement , image quality and radiation dose in coronary CT angiography ( cCTA ) studies when using a combination of iterative reconstruction and low tube voltage .


120 patients who underwent cCTA were randomly divided into two groups .


The patients in group A received iopromide 370 were scanned using the conventional tube output , and images were reconstructed using filtered back projection ( FBP ) .


The patients in group B received iodixanol 270 were scanned using the low tube output , and images were reconstructed using iterative reconstruction technique ( SAFIRE , Siemens Healthcare ) .


CT attenuation was measured in the coronary arteries , great arteries , interventricular septum and left ventricular cavity .


Noise , subjective image quality scores and effective radiation dose were compared between the two groups .


There was no significant difference in the mean CT attenuation achieved , image noise and mean image quality score at each anatomic site between iomeprol 270 group and iopromide 370 group .


The effective radiation dose were 0.44 0.25 mSv and 0.94 0.42 mSv for iomeprol 270 and iopromide 370 in low weight subgroups , and 1.17 0.30 mSv and 2.37 0.66 mSv in high weight subgroups , respectively , reflecting dose savings of 53.2 % ( P < 0.01 ) and 50.6 % ( P < 0.01 ) , respectively .


The results demonstrate that with a combination of iterative reconstruction and a low tube voltage , a low iodine concentration of 270 mgI/ml still improves the contrast enhancement without impairing image quality , as well as significantly lowers effective radiation dose .


A prospective , randomized , and controlled clinical trial .


To compare surgical zipper with subcuticular Monocryl sutures in terms of incision closure time , cosmetic results , and the complication rate in patients with adolescent idiopathic scoliosis ( AIS ) undergoing posterior spinal fusion ( PSF ) surgery .


In previous literatures , the application of surgical zipper to incision closure has been reported to be associated with a favorable outcome .


However , in the PSF surgery of patients with AIS , the use of surgical zipper has not been described .


Ninety female patients with AIS undergoing PSF were assigned randomly to 2 incision closure groups either using surgical zipper or using the 4-0 absorbable subcuticular suture .


The incision outcome was evaluated with the Hollander Incision Evaluation Score at 7 days , 2 weeks , 6 months , and 1 year after surgery , respectively .


Besides , a visual analogue scale was allocated to each patient to rate the cosmetic result of the incision .


The 2 groups were compared to determine the differences in terms of incision closure time , the complication rate , and cosmetic results .


The incision closure using surgical zipper consumed significantly less time than that using subcuticular suture ( 45.3 vs. 540.5 s , P < 0.001 ) .


As for the cosmetic results , no significant differences of Hollander Incision Evaluation Score scores between the 2 suturing groups were found .


Besides , patients ' satisfaction with cosmetic outcome on a linear visual analogue scale also revealed similar results between the 2 groups .


As for postoperative complications , we found 1 case of mild blister due to allergy to the tape of the dressings and 2 cases of incisional pain in the Monocryl suture group .


The application of surgical zipper in PSF surgery is a safe and effective method .


The ease and the speed of application make surgical zipper an attractive option for incision closure in patients with AIS undergoing PSF .


4 .


D-dimer is related to adverse outcomes in arterial and venous thromboembolic diseases .


To evaluate the predictive value of D-dimer level for stroke , other cardiovascular events , and bleeds , in patients with atrial fibrillation ( AF ) treated with oral anticoagulation with apixaban or warfarin ; and to evaluate the relationship between the D-dimer levels at baseline and the treatment effect of apixaban vs. warfarin .


In the ARISTOTLE trial , 18201 patients with AF were randomized to apixaban or warfarin .


D-dimer was analyzed in 14878 patients at randomization .


The cohort was separated into two groups ; not receiving vitaminK antagonist ( VKA ) treatment and receiving VKA treatment at randomization .


Higher D-dimer levels were associated with increased frequencies of stroke or systemic embolism ( hazard ratio [ HR ] [ Q4 vs. Q1 ] 1.72 , 95 % confidence interval [ CI ] 1.14-2 .59 , P = 0.003 ) , death ( HR [ Q4 vs. Q1 ] 4.04 , 95 % CI3.06-5 .33 ) and major bleeding ( HR [ Q4 vs. Q1 ] 2.47 , 95 % CI1.77-3 .45 , P < 0.0001 ) in the no-VKA group .


Similar results were obtained in the on-VKA group .


Adding D-dimer level to the CHADS2 score improved the C-index from 0.646 to 0.655 for stroke or systemic embolism , and from 0.598 to 0.662 for death , in the no-VKA group .


D-dimer level improved the HAS-BLED score for prediction of major bleeds , with an increase in the C-index from 0.610 to 0.641 .


There were no significant interactions between efficacy and safety of study treatment and D-dimer level .


In anticoagulated patients with AF , the level of D-dimer is related to the risk of stroke , death , and bleeding , and adds to the predictive value of clinical risk scores .


The benefits of apixaban were consistent , regardless of the baseline D-dimer level .


Rebleeding after an initial oesophageal variceal haemorrhage remains a significant problem despite therapy with band ligation , non-selective - blockers or a combination of these .


Carvedilol is a vasodilating non-selective - blocker with alpha-1 receptor and calcium channel antagonism .


A recent study has suggested it is effective in the prevention of a first variceal bleed .


Our aim was to compare oral carvedilol with variceal band ligation ( VBL ) in the prevention of rebleeding following a first variceal bleed .


Patients who were stable 5 days after presentation with a first oesophageal variceal haemorrhage and had not been taking - blockers were randomised to oral carvedilol or VBL .


Patients were followed-up after one week , monthly , then every 3 months .


The primary end point was variceal rebleeding on intention-to-treat analysis .


64 patients were randomised , 33 to carvedilol and 31 to VBL .


58 ( 90.6 % ) patients had alcohol related liver disease .


Age and Child-Pugh score were similar in both groups at baseline .


Median follow-up was 26.3 ( interquartile range [ IQR ] 10.2-46 .6 ) months .


Compliance was 68 % and 65 % for carvedilol and VBL respectively ( p = 0.993 ) and serious adverse events between the two groups were similar ( p = 0.968 ) .


Variceal rebleeding occurred during follow-up in 12 ( 36.4 % ) and 11 ( 35.5 % ) patients in the carvedilol and VBL groups , respectively ( p = 0.857 ) , with 9 ( 27.3 % ) and 16 ( 51.6 % ) deaths in each group , respectively ( p = 0.110 ) .


Carvedilol is not superior to VBL in the prevention of variceal rebleeding .


The trend to a survival benefit for patients taking this drug compared with those undergoing banding requires further exploration .


Alcohol is responsible for a large and growing proportion of the global burden of disease , as well as being the cause of social problems .


Brief interventions are one component of comprehensive policy measures necessary to reduce these harms .


Brief interventions increasingly take advantage of the Internet to reach large numbers of high risk groups such as students .


The research literature on the efficacy and effectiveness of online interventions is developing rapidly .


Although many studies show benefits in the form of reduced consumption , other intervention studies show no effects , for reasons that are unclear .


Sweden became the first country in the world to implement a national system in which all university students are offered a brief online intervention via an e-mail .


This randomized controlled trial ( RCT ) aims to evaluate the effectiveness of this national system comprising a brief online intervention among university students who are hazardous and harmful drinkers .


This study employs a conventional RCT design in which screening to determine eligibility precedes random allocation to immediate or delayed access to online intervention .


The online intervention evaluated comprises three main components ; assessment , normative feedback and advice on reducing drinking .


Screening is confined to a single question in order to minimise assessment reactivity and to prevent contamination .


Outcomes will be evaluated after 2 months , with total weekly alcohol consumption being the primary outcome measure .


Invitations to participate are provided by e-mail to approximately 55,000 students in 9 Swedish universities .


This RCT evaluates routine service provision in Swedish universities via a delay in offer of intervention to the control group .


It evaluates effects in the key population for whom this intervention has been designed .


Study findings will inform the further development of the national service provision .


ISRCTN02335307 .


To determine whether the new selective binding agent sugammadex causes less postoperative nausea and vomiting ( PONV ) than the cholinesterase inhibitor neostigmine .


Prospective , randomized , double-blinded study .


University-affiliated hospital .


One hundred American Society of Anesthesiologists physical status 1 and 2 patients scheduled for extremity surgery .


Patients were randomly assigned to neostigmine ( 70 g/kg ) and atropine ( 0.4 mg per mg neostigmine ) or sugammadex 2 mg/kg for neuromuscular antagonism at the end of anesthesia , when 4 twitches in response to train-of-four stimulation were visible with fade .


We recorded PONV , recovery parameters , antiemetic consumption , and side effects .


Nausea and vomiting scores were lower in the sugammadex patients upon arrival in the postanesthesia care unit ( med : 0 [ min-max , 0-3 ] vs med : 0 [ min-max , 0-3 ] ; P < .05 ) , but thereafter low and comparable .


Postoperative antiemetic and analgesic consumption were similar in each group .


Extubation ( median [ interquartile range ] , 3 [ 1-3 .25 ] vs 4 [ 1-3 .25 ] ; P < .001 ) first eye opening ( 4 [ 3-7 .25 ] vs 7 [ 5-11 ] ; P < .001 ) , and head lift ( 4 [ 2-7 .25 ] vs 8 [ 11-25 ] ; P < .001 ) in minutes were shorter in patients given sugammadex .


Postoperative heart rates were significantly lower in all measured times patients given neostigmine .


Nondepolarizing neuromuscular blocking antagonism with sugammadex speeds recovery of neuromuscular strength but only slightly and transiently reduces PONV compared with neostigmine and atropine .


Intravitreal high dose ( 2 mg ) ranibizumab may lead to quicker resolution of choroidal neovascularization ( CNV ) and associated retinal pigment epithelial detachment in eyes with exudative age-related macular degeneration , although it may possibly correlate with RPE tears in certain cases .


This prospective study compared the outcomes of 0.5 vs 2.0 mg intravitreal ranibizumab injections ( RI ) for treating vascularized pigment epithelial detachment ( vPED ) due to age-related macular degeneration .


Patients with vPED were randomized to receive 2.0 vs 0.5 mg RI monthly for 12 months or for 4 months and then repeated on a pro-re nata basis .


Optical coherence tomography , fundus photography , and fluorescein and indocyanine-green angiography were obtained at baseline and subsequent specific intervals .


Outcome measures were best-corrected standardized visual acuities , central 1-mm thickness , surface area ( SA ) , greatest linear diameter ( GLD ) , heights ( PED and CNV ) , and amount of subretinal fluid ( SRF ) and cystoid macular edema ( CME ) .


Both groups yielded reductions of the central 1-mm thickness , PED and CNV SA and PED height and GLD , SRF , and CME .


Vision improvement and reduction in SRF and PED height occurred earlier for eyes receiving the 2.0 mg dose .


Cataract progression was similar but RPE tears developed more often with the 2.0 mg dose .


There were similar visual and anatomical outcomes at the end of the study ; however , the higher dose yielded more rapid reductions and more complete resolution of the PED , although there was possible increased tendency for an RPE tear with the higher dose .


Acute kidney injury ( AKI ) is associated with increased mortality .


While angiotensin-converting enzyme inhibitors ( ACEI ) are known to slow progression of chronic kidney disease , their role in AKI remains unclear .


The Randomised Evaluation of Normal vs. Augmented Level Replacement Therapy ( RENAL ) study data were analysed according to ACEI use over time .


The primary outcome was all-cause mortality at 90 days following randomisation .


Analyses used a multivariate Cox model adjusted for either baseline or for time-dependent covariates , and a sensitivity analysis of patients surviving to at least the median time to ACEI initiation .


Of the 1463 participants with available data on ACE inhibitors usage , 142 ( 9.7 % ) received ACEI at least once during study data collection .


Participants treated with ACEI were older ( P = 0.02 ) and had less sepsis at baseline ( P < 0.001 ) .


ACEI use was significantly associated with lower mortality at 90 days ( HR 0.46 , 95 % CI 0.30-0 .71 , P < 0.001 ) , and an increase in renal replacement therapy-free days ( P < 0.001 ) , intensive care unit-free days ( P < 0.001 ) and hospital free-days ( P < 0.001 ) after adjusting for baseline covariates .


Using the time-dependent analysis , however , the effect of ACEI administration was not significant ( HR 0.78 , 95 % CI 0.51-1 .21 , P = 0.3 ) .


The sensitivity analysis in day 8 survivors produced similar results .


In the RENAL study cohort , the use of ACEI during the study was not common and , after adjustment for time-dependent covariates , was not significantly associated with reductions in mortality .


Further assessment of the effect of ACEI use in AKI patients is needed .


To observe effects of syndrome-differentiation acupuncture on life quality in patients with functional dyspepsia ( FD ) in order to evaluate its clinical efficacy .


One hundred and five cases of FD were randomly divided into a syndrome-differentiation acupuncture group , a regular acupuncture group and a non-acupoint group , 35 cases in each one .


Zhongwan ( CV 12 ) , Tianshu ( ST 25 ) , Zusanli ( ST 36 ) were selected as main acupoints in the syndrome-differentiation acupuncture group .


After syndrome differentiation , Danzhong ( CV 17 ) and Zhangmen ( LR 13 ) were added for those with stagnation of liver qi ; Pishu ( BL 20 ) and Weishu ( BL 21 ) were added for those with deficiency of spleen-stomach qi ; Qimen ( LR 14 ) and Taichong ( LR 3 ) were added for liver-qi invading stomach and Yinlingquan ( SP 9 ) and Neiting ( ST 44 ) were added for dampness-heat blocking stomach .


The selection of acupoints in the regular acupuncture group was the same as main acupoints in the syndrome-differentiation acupuncture group .


The points 10 mm lateral to the main acupoints were selected in the non-acupoint group .


The treatment was given once a day , six days as a treatment course and totally two courses were required .


The symptom total score , health-related quality of life survey ( SF-36 ) and Nepean dyspepsia index ( NDI ) were evaluated before and after the treatment as well as one month after the treatment ( follow-up visit ) , respectively .


The efficacy was also assessed .


After the treatment , the total effective rate was 87.5 % ( 28/32 ) in the syndrome-differentiation acupuncture group , which was superior to 74.2 % ( 23/31 ) in the regular acupuncture group and 20.7 % ( 6/29 ) in the non-acupoint group ( P < 0.05 , P < 0.01 ) .


Compared before the treatment , the SF-36 , NDI and symptom total score after the treatment and in the follow-up visit were all obviously improved in the syndrome-differentiation acupuncture group and regular acupuncture group ( all P < 0.05 ) , which was the most obvious in the syndrome-differentiation acupuncture group [ after the treatment , SF-36 : 84.54 + / - 5.93 vs 81.44 + / - 6.22 , 63.46 + / - 6.59 ; NDSI : 18.94 + / - 9.30 vs 21.23 + / - 8.39 , 43.93 + / - 11.26 ; NDLQI : 71.42 + / - 7.23 vs 63.11 + / - 7.06 , 54.87 + / - 6.00 ; symptom total score : 22.06 + / - 15.80 vs 32.52 + / - 16.88 , 47.97 + / - 10.92 ] ; the improvement in the regular acupuncture group was more obvious than that in the non-acupoint group ( P < 0.01 , P < 0.05 ) .


Compared before the treatment , only NDSI score was improved in the non-acupoint group after the treatment ( P < 0.05 ) .


The syndrome-differentiation acupuncture could obviously improve patient 's life quality in the treatment of FD , which is an effective therapy for FD .


To assess the efficacy of a mouthwash containing 2 % green tea as compared to a placebo mouthwash for the control of plaque and gingivitis .


A randomised controlled clinical trial was conducted on 110 male subjects 18-60 years of age .


The inclusion criteria were having a minimum of 20 sound natural teeth , a plaque index ( PI ) of at least 1.5 and a gingival index ( GI ) of at least 1.0 .


The subjects were randomised into two parallel groups , test and control .


Subjects in the test group and control group were instructed to rinse twice daily for 1 min with 10 ml of test ( mouthwash containing 2 % green tea ) and placebo mouthwash , respectively .


After 28 days of using the mouthwash , inter - and intragroup differences for mean plaque index and gingival index scores were analysed .


There was a significant ( p < 0.05 ) reduction in mean GI and PI scores among the test group from baseline to 28 days , whereas it was not significant in the control group .


A statistically significant ( p < 0.05 ) reduction was found in the mean difference in GI scores in the test group ( 0.67 0.22 ) as compared to the control group ( 0.05 0.11 ) and a statistically significant ( p < 0.05 ) reduction was observed in the mean difference in PI scores in the test group ( 1.65 0.68 ) compared to the control group ( 0.45 0.99 ) .


The results showed that the green tea mouthwash was effective in the reduction of plaque and gingivitis scores .


Mixed ( subsyndromal hypomanic ) features are prevalent in patients with bipolar depression and are associated with more severe and complex illness , including increased risk for suicide attempts , higher switch to mania during antidepressant therapy , and a higher rate of recurrence .


The aim of this post hoc analysis was to evaluate the efficacy and safety of lurasidone in the treatment of patients with bipolar depression presenting with mixed features .


Patients with a DSM-IV-TR diagnosis of major depressive episode associated with bipolar I disorder , with or without rapid cycling , and with a Montgomery-Asberg Depression Rating Scale ( MADRS ) score 20 and a Young Mania Rating Scale ( YMRS ) score 12 were randomly assigned to 6 weeks of double-blind , once-daily treatment with lurasidone 20-60 mg , lurasidone 80-120 mg , or placebo .


The presence of mixed features was defined as a YMRS score 4 at study baseline .


Efficacy analyses included change in MADRS total score from baseline to week 6 ( the primary outcome in the original study , conducted between April 2009 and February 2012 ) .


At baseline , mixed features were present in 56 % of patients ( lurasidone , n = 182/323 ; placebo , n = 90/162 ) .


Treatment with lurasidone ( vs placebo ) was associated with significantly greater reductions in MADRS scores in the mixed features group ( -15.7 vs -10.9 ; P = .001 ; week 6 ; mixed model for repeated measures [ MMRM ] ; effect size , 0.48 ) and in the group without mixed features ( -15.2 vs -10.8 ; P = .002 ; week 6 ; MMRM ; effect size , 0.48 ) .


Rates of protocol-defined treatment-emergent hypomania or mania were similar for patients with mixed features ( lurasidone , 2.2 % ; placebo , 3.2 % ) and without mixed features ( lurasidone , 3.4 % ; placebo , 0.0 % ) .


Lurasidone was found in this post hoc analysis to be efficacious in the treatment of patients with bipolar depression who present with mixed features ( assessed cross-sectionally at study baseline ) .


No increased risk of treatment-emergent mania was observed in either group .


ClinicalTrials.gov identifier : NCT00868699 .


The present study observed the clinical outcomes of the sodium cantharidinate/vitamin B6/GP regimen in the treatment of middle-late stage Non-small-cell lung carcinoma ( NSCLC ) .


Eighty-six cases of NSCLC were selected and randomized into two groups .


Forty-five cases in the treatment group were subject to 30 ml cantharidinate/vitamin B6 + GP regimen , for four 21-day cycles .


Forty-one cases in the control group were subject to regular GP regimen , for four 21-day cycles .


The effectiveness rate was 57.8 % in the treatment group and 36.6 % in the control group , suggesting statistical difference ( P < 0.05 ) ; life quality in the treatment group was significantly better than that in the control group ( P < 0.05 ) ; the occurrence rate of the toxic/adverse effects were significantly lower in the treatment group compared with that in the control group ( P < 0.05 ) .


Sodium cantharidinate/vitamin B6/GP regimen had fair effectiveness and synergistically improved the clinical outcomes .


It lowered the toxic/adverse effects and its application is worth further investigation and promotion .


Approximately 70 % of homeless youth smoke cigarettes , but their use of alternative tobacco products ( ATPs ) is unknown .


This paper reports on ATP use among past-month smokers in Los Angeles County , including whether it differs by demographic characteristics , homelessness severity , past-year quit attempts , and readiness to quit smoking .


Given the growing popularity of e-cigarettes , we also report on perceptions of harm and reasons for using this product .


We surveyed 292 unaccompanied homeless youth who were randomly sampled from street sites .


Participants had smoked at least 100 cigarettes during their lifetime and 1 cigarette during the past month .


Seventy-two percent of youth reported past-month ATP use ( e-cigarettes = 51 % ; little cigars/cigarillos = 46 % ; hookah = 31 % ; other smokeless tobacco product = 24 % ; chewing tobacco/moist snuff = 19 % ) .


Current ATP use was unrelated to most demographic characteristics or having a past-year quit attempt .


However , youth who planned to quit smoking in the next 30 days were significantly less likely to report current use of hookahs , other smokeless tobacco products , or e-cigarettes .


Among lifetime e-cigarette users , the most common reasons for use included not having to go outside to smoke ( 38 % ) and being able to deal with situations or places where they can not smoke ( 36 % ) ; it was less common to report using e-cigarettes to quit smoking ( 17 % -18 % ) .


Dual use of ATPs among homeless youth smokers is common and is more likely among those who have no immediate plans to quit smoking .


Effective and easily disseminable strategies for reducing all forms of tobacco use among homeless youth are urgently needed .


Rifabutin has been known to be effective in multidrug-resistant Helicobacter pylori-harboring patients undergoing treatment failure for H. pylori infection .


To evaluate the efficacy of 7-day treatment regimen consisting rifabutin daily but increasing the dose of amoxicillin and lansoprazole in patients who have failed first and second eradication and to assess the side effect profiles in South Korea .


From December 2007 to May 2013 , 59 H. pylori-infected patients with two previous eradication failures were enrolled for this study prospectively .


The eligible patients were randomly assigned to either group A or B. Group A received lansoprazole 30 mg bid , amoxicillin 1.0 g tid and rifabutin 150 mg bid during 7 days , whereas group B received lansoprazole 60 mg bid , amoxicillin 1.0 g tid and rifabutin 150 mg bid during 7 days .


In group A , H. pylori eradication was achieved in 25 ( 78.1 % ) of the 32 patients in the ITT analysis and in 25 ( 80.6 % ) of the 31 patients in the PP analysis .


In group B , H. pylori eradication was achieved in 26 ( 96.3 % ) of the 27 patients in the ITT analysis and in 27 ( 100 % ) of the 26 patients in the PP analysis .


There was statistically significant difference between the two groups in terms of the eradication rates in PP analysis ( p = .047 ) , whereas a marginally statistical significance was found in terms of the eradication rates in ITT analysis ( p = .051 ) .


Reported side effects were mild , and treatment was well tolerated .


No major changes in physical examination or in standard laboratory parameters were observed after treatment .


Rifabutin-based high-dose proton-pump inhibitor ( PPI ) - combined therapy as empirical rescue treatment is more effective than standard dose PPI-combined rifabutin-based therapy , safe and best tolerable in third-line therapy in the Korean population .


The key to successful rescue therapy with rifabutin-amoxicillin-PPI regimen may be to increase doses of PPI .


This open-label , randomized , phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide ( MPR ) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma .


We randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after induction , and 251 patients to lenalidomide maintenance therapy or no maintenance therapy .


The primary end point was progression-free survival .


The median follow-up period was 51.2 months .


Both progression-free and overall survival were significantly longer with high-dose melphalan plus stem-cell transplantation than with MPR ( median progression-free survival , 43.0 months vs. 22.4 months ; hazard ratio for progression or death , 0.44 ; 95 % confidence interval [ CI ] , 0.32 to 0.61 ; P < 0.001 ; and 4-year overall survival , 81.6 % vs. 65.3 % ; hazard ratio for death , 0.55 ; 95 % CI , 0.32 to 0.93 ; P = 0.02 ) .


Median progression-free survival was significantly longer with lenalidomide maintenance than with no maintenance ( 41.9 months vs. 21.6 months ; hazard ratio for progression or death , 0.47 ; 95 % CI , 0.33 to 0.65 ; P < 0.001 ) , but 3-year overall survival was not significantly prolonged ( 88.0 % vs. 79.2 % ; hazard ratio for death , 0.64 ; 95 % CI , 0.36 to 1.15 ; P = 0.14 ) .


Grade 3 or 4 neutropenia was significantly more frequent with high-dose melphalan than with MPR ( 94.3 % vs. 51.5 % ) , as were gastrointestinal adverse events ( 18.4 % vs. 0 % ) and infections ( 16.3 % vs. 0.8 % ) ; neutropenia and dermatologic toxic effects were more frequent with lenalidomide maintenance than with no maintenance ( 23.3 % vs. 0 % and 4.3 % vs. 0 % , respectively ) .


Consolidation therapy with high-dose melphalan plus stem-cell transplantation , as compared with MPR , significantly prolonged progression-free and overall survival among patients with multiple myeloma who were 65 years of age or younger .


Lenalidomide maintenance , as compared with no maintenance , significantly prolonged progression-free survival .


( Funded by Celgene ; ClinicalTrials.gov number , NCT00551928 . )


The Stockholm III Trial randomized patients with primary operable rectal cancers to either short-course radiotherapy ( RT ) with immediate surgery ( SRT ) , short-course RT with surgery delayed 4-8 weeks ( SRT-delay ) or long-course RT with surgery delayed 4-8 weeks .


This preplanned interim analysis examined the pathological outcome of delaying surgery .


Patients randomized to the SRT and SRT-delay arms in the Stockholm III Trial between October 1998 and November 2010 were included , and data were collected in a prospective register .


Additional data regarding tumour regression grade , according to Dworak , and circumferential margin were obtained by reassessment of histopathological slides .


A total of 462 of 545 randomized patients had specimens available for reassessment .


Patients randomized to SRT-delay had earlier ypT categories , and a higher rate of pathological complete responses ( 118 versus 17 per cent ; P = 0001 ) and Dworak grade 4 tumour regression ( 101 versus 17 per cent ; P < 0001 ) than patients randomized to SRT without delay .


Positive circumferential resection margins were uncommon ( 63 per cent ) and rates did not differ between the two treatment arms .


Short-course RT induces tumour downstaging if surgery is performed after an interval of 4-8 weeks .


Colonoscopy requires effective bowel preparation for adequate mucosal visualization .


Safety and acceptability of bowel preparation are key components in colorectal cancer screening ( CRC ) populations .


To compare the efficacy , safety and acceptability of bowel preparation with polyethylene glycol ( PEG ) , ascorbic acid , sodium ascorbate ( ascorbate components ) , sodium sulfate and electrolytes ( PEG+A sc ) or sodium phosphate ( NaP ) .


Consenting adults undergoing elective out-patient colonoscopy for CRC were randomized to take 2 L PEG+A sc or 90 mL NaP ( control ) following manufacturer 's instructions .


PEG+A sc was taken the evening before and morning of the colonoscopy ; NaP was taken the morning and evening before colonoscopy .


Participants followed a restricted diet specific to each preparation .


Primary endpoint was bowel cleansing success ( 100 % colon mucosa visible ) rated by an independent expert panel ( all experienced endoscopists ) unaware of treatment allocations .


Subject reported outcomes about the preparations were elicited .


Adverse events were recorded .


Clinicaltrials.gov : NCT00427089 .


Successful bowel cleansing rate was significantly higher in the PEG+A sc ( N = 242 ) than the NaP ( N = 114 ) group ( PEG+A sc 93.4 % [ 95 % CI 89.5-96 .2 ] versus NaP 22.8 % [ 15.5-31 .6 % ] , p < 0.0001 ) .


Subject reported outcomes on acceptability of the two different preparations were not significantly different ( p = 0.238 ) .


However , taste ratings for PEG+A sc were significantly better versus NaP ( mean VAS : 31.2 and 38.1 respectively , p = 0.0111 ) .


The proportion of patients prepared to receive the same preparation again was significantly higher in the PEG+A sc group ( 88.4 % vs. 78.1 % , p < 0.0001 ) .


PEG+A sc provided superior bowel cleansing to NaP and was well tolerated .


Findings for PEG+A sc are aligned with previous similar studies ; however , differences observed in NaP cleansing results , especially for the proximal colon segments , may be due to factors including : differences in demographics and population types and the use of the validated Harefield Cleansing Scale as an assessment tool combined with expert reviews , which may have resulted in conservative cleansing assessments .


Recent studies show that enzymatically hydrolysed collagen , the collagen peptide , is absorbed and distributed to joint tissues and has analgesic and anti-inflammatory properties .


A double-blind , placebo-controlled , randomised trial with collagen peptides isolated from pork skin ( PCP ) and bovine bone ( BCP ) sources was carried out to study the effectiveness of orally supplemented collagen peptide to control the progression of osteoarthritis in patients diagnosed with knee osteoarthritis .


Improvement in treatment was assessed with reduction in Western Ontario McMaster Universities ( WOMAC ) , visual analogue scale ( VAS ) and quality of life ( QOL ) scores from baseline to 13 weeks ( Visit 7 ) .


Safety and tolerability were also evaluated .


There was significant reduction from baseline to Visit 7 in the primary end points of WOMAC and VAS scores and in the secondary end point of QOL score in subjects with PCP and BCP groups , while in subjects with placebo group the end point indices remained unaltered .


Furthermore , all the score levels of WOMAC , VAS and QOL decreased significantly ( P < 0.01 ) in the study group compared to placebo group in Visit 7 .


The study demonstrated that collagen peptides are potential therapeutic agents as nutritional supplements for the management of osteoarthritis and maintenance of joint health .


To explore the feasibility , advantages and clinical value of gasless abdominal-wall lifting laparoscopic myomectomy with 5 mm laparoscope and 2 abdominal holes ( 1.5-hole-gasless-laparoscopic myomectomy ) .


A total of 90 cases of uterine fibroids were randomly divided into 2 groups .


Lifting gasless group ( n = 46 ) underwent gasless abdominal-wall lifting laparoscopic myomectomy with 5 mm laparoscope and 2 abdominal holes , and pneumoperitoneum group ( n = 44 ) pneumoperitoneum laparoscopic myomectomy .


The operative duration , blood loss volume , average time of single-myoma-removal , intestinal function recovery and hospital stay of both groups were compared .


The operative duration , blood loss volume and average time of single-myoma-removal of lifting gasless group were respectively significantly less than those of pneumoperitoneum group ( P < 0.01 ) .


The postoperative intestinal function recovery and postoperative hospital stay had no significant difference between two groups ( P > 0.05 ) .


Three cases of pneumoperitoneum group were converted successfully into myomectomy with traditional 3-hole gasless abdominal wall lifting laparoscopy because of large fibroids in uterine isthmus .


A total of 12 newly discovered myomas , not pre-detected ultrasonically , were removed in 10 cases of lifting gasless group .


1.5-hole-gasless-laparoscopic myomectomy , like traditional gasless laparoscopy , may avoid the complications of laparoscopic CO2 pneumoperitoneum .


The smaller laparoscope-hole and sole operating hole make this maneuver a safe , easy and mini-invasive procedure .


It is more suitable for clinical application and popularity in primary care .


To identify an optimal margin about the gross target volume ( GTV ) for stereotactic radiosurgery ( SRS ) of brain metastases , minimizing toxicity and local recurrence .


Adult patients with 1 to 3 brain metastases less than 4 cm in greatest dimension , no previous brain radiation therapy , and Karnofsky performance status ( KPS ) above 70 were eligible for this institutional review board-approved trial .


Individual lesions were randomized to 1 - or 3 - mm uniform expansion of the GTV defined on contrast-enhanced magnetic resonance imaging ( MRI ) .


The resulting planning target volume ( PTV ) was treated to 24 , 18 , or 15 Gy marginal dose for maximum PTV diameters less than 2 , 2 to 2.9 , and 3 to 3.9 cm , respectively , using a linear accelerator-based image-guided system .


The primary endpoint was local recurrence ( LR ) .


Secondary endpoints included neurocognition Mini-Mental State Examination , Trail Making Test Parts A and B , quality of life ( Functional Assessment of Cancer Therapy-Brain ) , radionecrosis ( RN ) , need for salvage radiation therapy , distant failure ( DF ) in the brain , and overall survival ( OS ) .


Between February 2010 and November 2012 , 49 patients with 80 brain metastases were treated .


The median age was 61 years , the median KPS was 90 , and the predominant histologies were non-small cell lung cancer ( 25 patients ) and melanoma ( 8 ) .


Fifty-five , 19 , and 6 lesions were treated to 24 , 18 , and 15 Gy , respectively .


The PTV/GTV ratio , volume receiving 12 Gy or more , and minimum dose to PTV were significantly higher in the 3-mm group ( all P < .01 ) , and GTV was similar ( P = .76 ) .


At a median follow-up time of 32.2 months , 11 patients were alive , with median OS 10.6 months .


LR was observed in only 3 lesions ( 2 in the 1 mm group , P = .51 ) , with 6.7 % LR 12 months after SRS .


Biopsy-proven RN alone was observed in 6 lesions ( 5 in the 3-mm group , P = .10 ) .


The 12-month DF rate was 45.7 % .


Three months after SRS , no significant change in neurocognition or quality of life was observed .


SRS was well tolerated , with low rates of LR and RN in both cohorts .


However , given the higher potential risk of RN with a 3-mm margin , a 1-mm GTV expansion is more appropriate .


Depression and anxiety disorders during adolescence can have detrimental consequences .


Both disorders are related to negative outcome in various areas during adolescence and are also predictive of depression and anxiety disorders later in life .


Especially parental psychopathology and being female are risk factors that increase the probability of developing one of these disorders during adolescence .


Research has shown that prevention programs have promising results , especially for adolescents who have these risk factors .


Therefore , in this study , we will focus on the effectiveness of a prevention program ' A jump forward ' that has been developed for adolescent girls with a familial risk of depression and/or anxiety .


We designed a randomized controlled trial to test the effectiveness of an indicated and selective prevention program aimed at depression and anxiety in adolescent girls .


Adolescents aged between 11 and 15 years old with depressive and/or anxiety symptoms and with parents who show indicators of parental psychopathology will be randomly assigned to the experimental ( N = 80 ) or control groups ( N = 80 ) .


Participants in the experimental group will follow a preventive intervention , consisting of six sessions of 90 minutes each .


All participants will complete baseline , intervention phase 1 ( after session 2 ) , intervention phase 2 ( after session 4 ) , post-intervention , 6 month follow-up , and 12 month follow-up assessments .


Furthermore , parents will be asked to complete assessments at baseline , post-intervention , and 12-month follow-up .


Primary outcome will be depressive symptoms .


Secondary outcomes will be anxiety symptoms , suicidal ideation , response style , negative cognitive errors , parental emotional support and parental control , parental psychopathology , parenting stress and adolescents ' depression and anxiety symptoms according to the parents .


This paper described the study designed to evaluate a program for preventing depression and/or anxiety in high-risk adolescents over a 12-month follow-up period .


If the program showed to be effective in reducing symptoms of depression and anxiety and preventing adolescents from developing clinical levels of these disorders , our results would be relevant to practice .


Thus , the intervention could be used on a large scale .


Moreover , this study aims to contribute to the evidence-based prevention of depression and anxiety of adolescents .


Dutch Trial Register NTR3720 .


The phosphotidylinositol-3 kinase/serine-threonine kinase ( AKT ) / mammalian target of rapamycin signaling pathway is frequently altered in non-small-cell lung cancer ( NSCLC ) .


PX-866 is an oral , irreversible , pan-isoform inhibitor of phosphotidylinositol-3 kinase .


Preclinical models revealed synergy with docetaxel and a phase 1 trial demonstrated tolerability of this combination .


This randomized phase 2 study evaluated PX-866 combined with docetaxel in patients with advanced , refractory NSCLC .


Patients with locally advanced , recurrent , or metastatic NSCLC who had received at least one and no more than two prior systemic treatment regimens were randomized ( 1:1 ) to a combination of docetaxel ( 75 mg/m intravenous every 21 days ) with or without PX-866 ( 8 mg orally daily ; arms A and B , respectively ) .


The primary end point was progression-free survival ( PFS ) .


Secondary end points included objective response rate , overall survival ( OS ) , toxicity , and correlation of biomarker analyses with efficacy outcomes .


A total of 95 patients were enrolled .


Median PFS was 2 months in arm A and 2.9 months in arm B ( p = 0.65 ) .


Objective response rates were 6 % and 0 % in arms A and B , respectively ( p = 0.4 ) .


There was no difference in OS between the two arms ( 7.0 versus 9.2 months ; p = 0.9 ) .


Grade 3 or higher adverse events were infrequent , but more common in the combination arm with respect to diarrhea ( 7 % versus 2 % ) , nausea ( 4 % versus 0 % ) , and vomiting ( 7 % versus 0 % ) .


PIK3CA mutations or PTEN loss were infrequently observed .


The addition of PX-866 to docetaxel did not improve PFS , response rate , or OS in patients with advanced , refractory NSCLC without molecular preselection .


Earlier studies on the management of metabolic syndrome ( MetS ) have mostly focused on very low carbohydrate diets , whereas long-term adherence to such diets is difficult for apparently healthy people .


The aim of this study was to examine the effects of moderate replacement of carbohydrates by dietary fats on insulin resistance and features of MetS among women .


This randomized crossover clinical trial was performed with 30 overweight or obese ( body mass index [ BMI ] > 25 kg/m ( 2 ) ) women with MetS .


After a 2-wk run-in period , participants were randomly assigned to consume either a calorie-restricted high-carbohydrate ( HC ) diet ( 60 % -65 % of energy from carbohydrates and 20 % -25 % from fats ) or a calorie-restricted moderately restricted carbohydrate ( MRC ) diet ( 43 % -47 % of total calories as carbohydrate and 36 % -40 % as dietary fats ) for 6 wk .


Protein contents of both diets were 15 % to 17 % of total energy .


A 2-wk washout period was applied following which participants were crossed over to the alternate treatment arm for an additional 6 wk .


Anthropometric , blood pressure , and biochemical measurements were performed before and after each phase of intervention .


Mean age and BMI of study participants was 42.4 y and 33 kg/m ( 2 ) , respectively .


A trend toward greater reduction in waist ( -3.9 versus -2.6 cm ; P = 0.07 ) and hip circumferences ( -2.7 versus -1.5 cm ; P = 0.07 ) as well as serum triglyceride ( TG ) levels ( -31.3 versus 0.13 mg/dL ; P = 0.07 ) was observed after consumption of an MRC diet compared with an HC diet .


The TG to high-density lipoprotein cholesterol ( HDL-C ) ratio had a tendency to improve with the MRC diet rather than the HC diet ( -0.9 versus -0.1 ; P = 0.06 ) .


Consumption of the MRC diet resulted in a greater reduction of systolic blood pressure ( -8.93 versus -2.97 mm Hg ; P = 0.06 ) and diastolic blood pressure ( -12.7 versus -1.77 mm Hg ; P = 0.001 ) compared with the HC diet .


The prevalence of MetS was significantly decreased following the consumption of the MRC diet ( P = 0.03 ) .


The two diets were not significantly different in terms of their effect on fasting plasma glucose , serum HDL-C , low-density lipoprotein cholesterol , and total cholesterol , insulin levels , and Homeostasis Model Assessment-Insulin Resistance .


Moderate replacement of carbohydrates by dietary fats was not associated with statistically different changes in fasting plasma glucose , insulin , or atherogenic dyslipidemia among individuals with the metabolic syndrome ; however , it resulted in decreased diastolic blood pressure and lower prevalence of the metabolic syndrome .


Lymphoceles are among the most common post-operative complications of pelvic lymphadenectomy , with a reported incidence of 1 % to 29 % in gynecology oncology .


Several studies evaluated the effectiveness of biological glues on reducing lymphoceles , but no data on gynecological patients are available .


We evaluated the effectiveness of cyanoacrylic glues ( n-butyl cyanoacrylate ) ( Glubran 2 - GEM s.r.l. , Italy ) in preventing lymphocele on 30 patients who underwent pelvic lymphadenectomy for endometrial or cervical cancer .


Single-blind prospective randomized study .


Patients were divided into 2 groups : pelvic lymphadenectomy plus n-butyl cyanoacrylate ( treatment group : 44 patients ) and pelvic lymphadenectomy without n-butyl cyanoacrylate ( control group : 44 patients ) .


Primary endpoint was incidence of pelvic lymphocele in the two groups 30 days after surgery , and evaluated with pelvic ultrasound and RMI examination .


Secondary endpoints evaluated drainage volume of lymphorrhea 36 , 48 , 72 and 96 h after surgery .


15 % in the treatment group and 36.6 % in the control group had lymphocele 1month after the procedure ( p < 0.03 ; RR 0.4 [ 95 % CI 0.152-0 .999 ] ) .


Concerning the secondary outcome in group A the amount of lymphorrhea presented a constant significant decrease during evaluation ; on the contrary , in group B , after an initial decrease at 48 h , the amount of lymphorrhea remained unchanged ; at all considered times the amount of lymphorrhea resulted significantly greater in controls .


Intraoperative application of n-butyl cyanoacrylate seems to reduce lymph production after pelvic lymphadenectomy , providing a useful additional treatment option for reducing drainage volume and preventing lymphocele development after pelvic lymphadenectomy .


To observe the clinical effect of electric stimulation of long-term retaining needle on analgesia after laparoscopic cholecystectomy ( LC ) and the impacts on the post-surgical flatus time .


Under static absorptive composite general anesthesia , 90 cases of LC were randomized into three groups , 30 cases in each one .


In the control group , the analgesia was not applied after LC .


In the analgesia-pumper group , the patient controlled intravenous analgesia ( PCIA ) was used .


In the needle-retaining group , the electric acupuncture stimulator was used .


The needles were inserted transversely at Riyue ( GB 24 ) , Qichong ( ST 30 ) and Yanglingquan ( GB 34 ) and fixed with sterile sticker .


Separately , in 8 h and 24 h after surgery , the electric acupuncture stimulation with disperse-dense wave , 2 Hz/100 Hz frequency was applied continuously for 30 min .


Visual analogue scale ( VAS ) , adverse reactions such as vomiting and nausea and the postoperative flatus time in 2 , 4 , 8 , 12 , 24 and 36 h after surgery were observed and recorded in the three groups .


In 2 , 4 , 8 , 12 and 24 h after surgery , VAS scores in the needle-retaining group and the analgesia-pumper group were all lower than those in the control group ( P < 0.05 , P < 0.01 ) .


The analgesia effect at the above time points in the needle-retaining group was better than that in the analgesia-pumper group ( all P < 0.05 ) .


There was not adverse reaction in the needle-retaining group .


But there were 3 cases of somnolence , 6 cases of nausea and 3 cases of vomiting in the analgesia-pumper group , and 2 cases of nausea and 1 case of vomiting in the control group .


The flatus time was quite earlier in the needle-retaining group as compared with the other two groups [ ( 14.77 + / - 4.99 ) h vs ( 18.50 + / - 4.22 ) h , P < 0.01 ; ( 14.77 + / - 4.99 ) h vs ( 18.17 + / - 4.69 ) h , P < 0.05 ] .


The electric stimulation of long-term retaining needle is safe and effective in analgesia after LC .


It avoids the adverse reactions of analgesics and promotes postoperative flatus .


Recently , we have shown advantages of a direct optical entry ( DOE ) using a bladeless trocar in comparison with the open Hasson technique ( OHT ) in older reproductive-age women with previous operations , as well as in comparison with Veress needle entry in reproductive-age and postmenopausal women .


A prospective multicenter randomized study to determine whether the DOE is feasible for establishing safe and rapid entry into the abdomen in comparison with those of the OHT in reproductive-age obese women .


Two types of surgical techniques were blindly applied in 224 obese reproductive-age women with benign neoplastic diseases of ovary and uterus .


Namely , laparoscopic entry into the abdomen in 108 patients was performed by DOE and in 116 women by OHT .


Following parameters ( entry time in seconds needed to establish the intra-abdominal vision after pneumoperitoneum , blood loss , occurrence of vascular and/or bowel injuries ) were compared during surgery as main outcomes .


Main baseline characteristics of patients , including age ( 36.1 4.5 vs 35.7 5.8 ) , body mass index ( 34.9 5.1 vs 35.1 4.9 kg/m ( 2 ) ) , and parity ( 2.1 0.4 vs 1.9 0.9 ) , were not significantly different between the DOE and OHT groups ( P > .05 ) .


While intraoperative parameters such as the entry time ( 71.9 3.7 vs 215.1 6.2 seconds ) and blood loss value ( 9.7 6.1 vs 12.2 2.9 mL ) were significantly reduced in the DOE group in comparison with those of OHT group ( respectively , P < .0001 and < .01 ) , there were also trends to slight decrease of the occurrence of the minor injuries , manifested as omental small vessels rupture ( 0 of 108 vs 4 of 116 ) and punctures and pinches of jejunal serosa ( 0 of 108 vs 3 of 116 ) in patients of the DOE group in comparison with those of OHT group ( respectively , P = .0515 and = .0925 ) .


DOE reduced entry time and blood loss with trends to slightly decrease of the occurrence of the minor vascular and bowel injuries , thus enabling a possible alternative to OHT in obese women ; however , further larger trials need to confirm the possible additional benefits of a DOE .


Family carers of people with dementia frequently become depressed or anxious .


In observational studies , more emotion-focused and less dysfunctional coping predict fewer psychological symptoms , but no randomised controlled trial ( RCT ) has directly investigated emotion-focused coping as mediator of effectiveness of a successful psychological intervention .


We hypothesised that emotion-focused coping would mediate the START psychological interventions effects in an RCT .


We tested whether mediated effects were moderated by severity of baseline symptoms .


260 family carers from NHS dementia services were randomised to START ( manualised coping skills intervention ) , or treatment-as-usual ( TAU ) .


Blinded raters administered the Hospital Anxiety and Depression Scale ( HADS-T ) and Brief COPE inventory at baseline , 4 and 8 months .


HADS-T improved in the intervention group when compared to TAU at all levels of psychological distress .


We tested whether coping was a mediator and for moderated mediation , and ( post-hoc ) subgroup treatment effects on coping .


Data were available for 187 carers ( 71.9 % ) for the mediation analysis .


The reduced HADS-T score in the intervention group was mediated by increased emotion-focused coping only among carers with higher ( 16 + ) baseline HADS-T scores ( mediated effect = -0.63 [ -1.11 , -0.15 ] ; proportion of overall effect = 33 % [ 3 % , 64 % ] ) .


We did not measure plausible psychosocial treatment mechanisms other than coping .


START benefited family carers both in preventing and treating psychological morbidity , through different mechanisms of action .


The most psychologically distressed carers increased their emotion-focused coping and did not decrease their dysfunctional coping , while others benefited but not through this mechanism .


To investigate the effect of 2 commonly used mydriatics on choroidal thickness using enhanced depth imaging optical coherence tomography ( EDI-OCT ) .


In this prospective study , 90 healthy subjects were enrolled .


The participants were randomly divided into 3 groups based on the application of drops .


One eye of each subject received a drop of tropicamide 1 % in the tropicamide group ( n = 30 ) , a drop of phenylephrine 2.5 % in the phenylephrine group ( n = 30 ) , and a drop of artificial tear in the control group ( n = 30 ) .


Drops were given thrice at 5min intervals .


Subfoveal choroidal thickness ( SFCT ) was measured using EDI-OCT before and at 45min after drop application in both the dilated eye and nondilated contralateral eye .


The SFCT was significantly decreased after drop instillation in both the dilated eye and contralateral eye in the tropicamide group ( P < 0.001 and P = 0.001 , respectively ) and in the phenylephrine group ( P < 0.001 and P = 0.001 , respectively ) .


However , the SFCT did not significantly differ after drop instillation in either the dropped eye or contralateral eye in the control group ( P = 0.108 and P = 0.695 , respectively ) .


The findings of the present study revealed that tropicamide and phenylephrine cause a decrease in choroidal thickness .


An inhaled gas absolute humidity of 20 mg H2OL is the value most considered as the threshold necessary for preventing the deleterious effects of dry gas on the epithelium of the airways during anesthesia .


Because children have small minute ventilation , we hypothesized that the humidification of a circle breathing system is lower in children compared with adults .


The Primus anesthesia workstation ( Drger Medical , Lbeck , Germany ) has a built-in hotplate to heat the patient 's exhaled gases .


A heat and moisture exchanger ( HME ) is a device that can be used to further humidify and heat the inhaled gases during anesthesia .


To evaluate the humidifying properties of this circle breathing system during pediatric anesthesia , we compared the temperature and humidity of inhaled gases under low or high fresh gas flow ( FGF ) conditions and with or without an HME .


Forty children were randomly allocated into 4 groups according to the ventilation of their lungs by a circle breathing system in a Drger Primus anesthesia workstation with low ( 1 Lmin ) or high ( 3 Lmin ) FGF without an HME ( 1L and 3L groups ) or with an HME ( Pall BB25FS , Pall Biomedical , East Hills , NY ; HME1L and HME3L groups ) .


The temperature and absolute humidity of inhaled gases were measured at 10 , 20 , 40 , 60 , and 80 minutes after connecting the patient to the breathing circuit .


The mean inhaled gas temperature was higher in HME groups ( HME1L : 30.3 C 1.1 C ; HME3L : 29.3 C 1.2 C ) compared with no-HME groups ( 1L : 27.0 C 1.2 C ; 3L : 27.1 C 1.5 C ; P < 0.0001 ) .


The mean inhaled gas absolute humidity was higher in HME than no-HME groups and higher in low-flow than high-flow groups ( [ HME1L : 25 1 mg H2OL ] > [ HME3L : 23 2 mg H2OL ] > [ 1L : 17 1 mg H2OL ] > [ 3L : 14 1 mg H2OL ] ; P < 0.0001 ) .


In a pediatric circle breathing system , the use of neither high nor low FGF provides the minimum humidity level of the inhaled gases thought to reduce the risk of dehydration of airways .


Insertion of an HME increases the humidity and temperature of the inhaled gases , bringing them closer to physiological values .


The use of a low FGF enhances the HME efficiency and consequently increases the inhaled gas humidity values .


Therefore , the association of an HME with low FGF in the breathing circuit is the most efficient way to conserve the heat and the moisture of the inhaled gas during pediatric anesthesia .


De novo donor-specific anti-human leukocyte antigen antibodies develop in a high proportion of lung transplant recipients early after lung transplantation .


We recently showed that de novo donor-specific antibodies ( DSA ) occurrence is associated with significantly increased mortality .


Here , we studied the efficacy of a preemptive treatment protocol .


A retrospective observational study was conducted on all lung transplantations at Hanover Medical School between January 2009 and May 2013 .


Among the 500 transplant recipients , early DSA developed in 86 ( 17 % ) .


Of these , 56 patients ( 65 % ; Group A ) received therapeutic plasma exchange , and 30 patients ( 35 % ; Group B ) did not .


Among Group A patients , 51 also received rituximab .


Between groups , there was no statistically significant difference in mortality , incidence of pulsed steroid therapies , rejections diagnosed by biopsy specimen , incidence of bronchitis obliterans syndrome ( BOS ) , or infections requiring hospitalization at 1 year and 3 years .


Also , there were no statistically significant differences after matching 21 Group A with 21 Group B patients through propensity score analysis .


Significantly more Group A patients ( 65 % ) than Group B patients ( 34 % ) cleared DSA at hospital discharge ( p = 0.01 ) .


At the last control after transplantation ( median , 14 months ; interquartile range , 5-24 months ) , 11 Group A ( 22 % ) and 9 Group B patients ( 33 % ) still showed DSA ( p = 0.28 ) .


Preemptive treatment with therapeutic plasma exchange and rituximab led to improved elimination of DSA early after lung transplantation ( p = 0.01 ) .


However , spontaneous elimination in untreated Group B patients also occurred frequently .


This treatment protocol was not associated with significantly improved outcome .


Low back pain is often accepted as a `` normal '' part of pregnancy .


Despite research suggesting that quality of life for women who are pregnant is adversely affected , most are advised to self-manage .


Although the use of acupuncture for the management of persistent nonspecific low back pain has been recommended in recent UK national guidelines , its use in the management of pregnancy-related low back pain remains limited .


This study aimed to explore the perceptions and experiences of physical therapists involved in treating women who are pregnant and have low back pain with the objective of informing the pretrial training program for a pilot randomized trial ( Evaluating Acupuncture and Standard care for pregnant womEn with Back pain [ EASE Back ] ) .


A qualitative phenomenological method with purposive sampling was used in the study .


Three focus groups and 3 individual semistructured interviews were undertaken , and an iterative exploratory thematic analysis was performed .


To ensure transparency of the research process and the decisions made , an audit trail was created .


Twenty-one physical therapists participated , and emergent issues included : a lack of experience in treating pregnancy-related complaints , mixed messages from previous acupuncture education , a mistrust of the current evidence for acupuncture safety and effectiveness , and personal and professional fear of causing harm .


The findings suggest that UK physical therapists are reluctant to use acupuncture in the management of pregnancy-related low back pain .


The explanations for these findings include perceived lack of knowledge and confidence , as well as a pervasive professional culture of caution , particularly fears of inducing early labor and of litigation .


These findings have been key to informing the content of the training program for physical therapists delivering acupuncture within the pilot EASE Back trial .


Tiotropium , a once-daily long-acting anticholinergic bronchodilator , when administered via Respimat SoftMist inhaler ( tiotropium Respimat ) significantly reduces the risk of severe exacerbations and improves lung function in patients with severe persistent asthma that is not fully controlled despite using inhaled corticosteroids ( ICS ) and long-acting 2-agonists .


To further explore the dose-response curve in asthma , we investigated the efficacy and safety of three different doses of tiotropium Respimat as add-on to ICS in symptomatic patients with moderate persistent asthma .


In this randomised , double-blind , placebo-controlled , four-way crossover study , patients were randomised to tiotropium Respimat 5g , 2.5 g or 1.25 g or placebo Respimat , once daily in the evening .


Each treatment was administered for 4weeks , without washout between treatment periods .


Eligibility criteria included 60 % and 90 % of predicted normal forced expiratory volume in 1second ( FEV1 ) and seven-question Asthma Control Questionnaire mean score of 1.5 .


Patients were required to continue maintenance treatment with stable medium-dose ICS for at least 4weeks prior to and during the treatment period .


Long-acting 2-agonists were not permitted during the treatment phase .


The primary efficacy end point was peak FEV1 measured within 3hours after dosing ( peak FEV1 ( 0-3h ) ) at the end of each 4-week period , analysed as a response ( change from study baseline ) .


In total , 149 patients were randomised and 141 completed the study .


Statistically significant improvements in peak FEV1 ( 0-3h ) response were observed with each tiotropium Respimat dose versus placebo ( all P < 0.0001 ) .


The largest difference from placebo was with tiotropium Respimat 5g ( 188mL ) .


Trough FEV1 and FEV1 area under the curve ( AUC ) ( 0-3h ) responses were greater with each tiotropium Respimat dose than with placebo ( all P < 0.0001 ) , and both were greatest with 5g .


Peak forced vital capacity ( FVC ) ( 0-3h ) , trough FVC and FVC AUC ( 0-3h ) responses , versus placebo , were greatest with tiotropium Respimat 5g ( P < 0.0001 , P = 0.0012 and P < 0.0001 , respectively ) .


Incidence of adverse events was comparable between placebo and all tiotropium Respimat groups .


Once-daily tiotropium Respimat add-on to medium-dose ICS improves lung function in symptomatic patients with moderate asthma .


Overall , improvements were largest with tiotropium Respimat 5g .


ClinicalTrials.gov identifier NCT01233284 .


Evolocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , significantly reduced low-density lipoprotein ( LDL ) cholesterol levels in phase 2 studies .


We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab .


We stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program .


On the basis of this classification , patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily , atorvastatin at a dose of 80 mg daily , or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily , for a run-in period of 4 to 12 weeks .


Patients with an LDL cholesterol level of 75 mg per deciliter ( 1.9 mmol per liter ) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab ( 420 mg ) or placebo every 4 weeks .


The primary end point was the percent change from baseline in LDL cholesterol , as measured by means of ultracentrifugation , at week 52 .


Among the 901 patients included in the primary analysis , the overall least-squares mean ( SE ) reduction in LDL cholesterol from baseline in the evolocumab group , taking into account the change in the placebo group , was 57.02.1 % ( P < 0.001 ) .


The mean reduction was 55.74.2 % among patients who underwent background therapy with diet alone , 61.62.6 % among those who received 10 mg of atorvastatin , 56.85.3 % among those who received 80 mg of atorvastatin , and 48.55.2 % among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe ( P < 0.001 for all comparisons ) .


Evolocumab treatment also significantly reduced levels of apolipoprotein B , non-high-density lipoprotein cholesterol , lipoprotein ( a ) , and triglycerides .


The most common adverse events were nasopharyngitis , upper respiratory tract infection , influenza , and back pain .


At 52 weeks , evolocumab added to diet alone , to low-dose atorvastatin , or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks .


( Funded by Amgen ; DESCARTES ClinicalTrials.gov number , NCT01516879 . )


Endoscopic stents are placed for palliation of extrahepatic bile duct obstruction .


Although self-expandable metal stents ( SEMS ) remain patent longer than plastic stents , they are more expensive .


We aimed to evaluate which type of stent ( plastic , uncovered SEMS [ uSEMS ] , or partially covered SEMS [ pcSEMS ] ) is the most effective and we assessed costs .


We performed a multicenter randomized trial in 219 patients at 18 hospitals in The Netherlands from February 2008 through February 2013 .


Patients were assigned randomly for placement of a plastic stent ( n = 73 ) , uSEMS ( n = 75 ) , or pcSEMS ( n = 71 ) during endoscopic retrograde cholangiopancreatography .


Patients were followed up for up to 1 year .


Researchers were not blinded to groups .


The main study end points included functional stent time and costs .


The mean functional stent times were 172 days for plastic stents , 288 days for uSEMS , and 299 days for pcSEMS ( P < .005 for uSEMS and pcSEMS vs plastic ) .


The initial placement of plastic stents ( 1042 or $ 1106 ) cost significantly less than placement of SEMS ( 1973 or $ 2094 ) ( P = .001 ) .


However , the total cost per patient at the end of the follow-up period did not differ significantly between plastic stents ( 7320 or $ 7770 ) and SEMS ( 6932 or $ 7356 ) ( P = .61 ) .


Furthermore , in patients with short survival times ( 3 mo ) or metastatic disease , the total cost per patient did not differ between plastic stents and SEMS .


No differences in costs were found between pcSEMS and uSEMS .


Although placement of SEMS ( uncovered or partially covered ) for palliation of extrahepatic bile duct obstruction initially is more expensive than placement of plastic stents , SEMS have longer functional time .


The total costs after 1 year do not differ significantly with stent type .


Dutch Clinical Trial Registration no : NTR1361 .


To determine whether ureteric stent extraction strings affect stent-related quality of life ( QoL ) or increase complications after ureteroscopy ( URS ) for stone disease .


In all , 68 patients undergoing URS ( October 2011 to May 2013 ) for stone disease were randomised to receive a ureteric stent with or without an extraction string .


Patients completed the Ureteric Stent Symptom Questionnaire ( USSQ ) on postoperative days 1 and 6 , and 6 weeks after stent removal .


Pain was assessed at stent removal .


Adverse events , including early stent removal , stent migration , retained stent , urinary tract infection ( UTI ) , emergency room ( ER ) visits and postoperative phone calls were monitored .


There was no difference in stent-related QoL as measured by the USSQ between those with and without a stent extraction string , pain at stent removal between those who pulled their stent independently vs those who underwent cystoscopy for stent removal , or in the rate of UTIs , ER visits or phone calls between groups .


Five patients ( four female , one male ) removed their stent early by inadvertently pulling the string ; none required replacement .


Patients without a string had a significantly longer period with the postoperative ureteric stent ( 10.6 vs 6.3 days , P < 0.001 ) .


One patient without a stent string retained her ureteric stent for 6 months , which was removed by cystoscopy without incident .


Ureteric stent extraction strings may offer several advantages without increasing stent-related urinary symptoms , complications , or postoperative morbidity .


Administration of a loading dose of a statin ( HMG-CoA reductase inhibitor ) prior to percutaneous coronary intervention ( PCI ) contributes to protection from myocardial ischemic-reperfusion injury .


This trial was designed to investigate the effect and mechanism of loading-dose rosuvastatin therapy before PCI in patients with acute coronary syndrome .


One hundred and forty-three patients with acute coronary syndrome were randomized to either the loading-dose ( rosuvastatin 40mg given 4h before PCI ) or conventional-dose ( rosuvastatin 10mg given 4h before PCI ) group .


Blood samples were collected before and 0 , 24 , and 72h post-PCI for measurement of serum cardiac troponin-I ( cTnI ) , creatine kinase-MB ( CK-MB ) , superoxide dismutase ( SOD ) , reactive oxygen species ( ROS ) , and malondialdehyde ( MDA ) .


Echocardiography and the major adverse cardiac/cerebrovascular events ( MACCE ) rate were followed up for 6months post-PCI .


Blood serum CK-MB and cTnI were significantly lower in the loading-dose group than in the conventional-dose group at 24 and 72h post-PCI [ CK-MB : 26.903.22 vs. 32.962.65 IU/L , P = 0.024 ; 10.794.65 vs. 15.185.39 IU/L , P = 0.021 .


cTnI : 0.0460.007 vs. 0.0550.002 ng/mL , P = 0.015 ; 0.0270.006 vs. 0.0410.006 ng/mL , P = 0.026 ] .


Echocardiography at 6months after PCI revealed significant improvement in cardiac function in the loading-dose group compared with the conventional-dose group ( P < 0.05 ) .


The MACCE rate at 6months after PCI in the loading-dose group was lower than in the conventional-dose group ( P = 0.0428 ) .


The levels of MDA and ROS were decreased and the SOD level was significantly higher in the loading-dose group than in the conventional-dose group at 0 , 24 , and 72h post-PCI ( P < 0.05 ) .


Administration of loading-dose rosuvastatin in patients with acute coronary syndrome prior to PCI exerts myocardial protection by inhibition of oxidative stress .


The variability in habitual intakes of most components in the Philippine diet is unknown .


To perform a quantitative evaluation of the traditional Philippine diet using data collected over an extended period of time .


We sought to identify seasonal variations and within-subject components of variation in nutrient intake .


A quantitative evaluation of the Philippine diet was conducted in convents in metropolitan Manila as part of an efficacy trial to examine biofortified rice as an approach to improve iron nutritional status .


Weighed food intakes were conducted on 54 days in each of more than 300 religious sisters over 9 months in 10 convents .


The sisters consumed their habitual diets except for the substitution of one variety of rice for another .


More than 40 % of calories were derived from rice , with protein from meat and fish comprising 18 % of calories .


There were significant variations in macronutrient and micronutrient intakes across seasons of the year , with more rice consumed in the wet season and more fruits , eggs , milk , and beverages consumed in the dry season .


The day-to-day within-subject variation ( CV ) in median intake was 23 % for energy , 31 % for protein , 42 % for iron , and 138 % for vitamin A.


These novel data show that traditional Filipino dietary patterns have substantial individual variation and are inadequate in certain micronutrients .


This quantitative evaluation of diet can provide a reference point for dietary adequacy .


To study whether the reinforced feedback in virtual environment ( RFVE ) is more effective than traditional rehabilitation ( TR ) for the treatment of upper limb motor function after stroke , regardless of stroke etiology ( i.e. , ischemic , hemorrhagic ) .


Randomized controlled trial .


Participants .


Forty-four patients affected by stroke .


Intervention .


The patients were randomized into two groups : RFVE ( N = 23 ) and TR ( N = 21 ) , and stratified according to stroke etiology .


The RFVE treatment consisted of multidirectional exercises providing augmented feedback provided by virtual reality , while in the TR treatment the same exercises were provided without augmented feedbacks .


Outcome Measures .


Fugl-Meyer upper extremity scale ( F-M UE ) , Functional Independence Measure scale ( FIM ) , and kinematics parameters ( speed , time , and peak ) .


The F-M UE ( P = 0.030 ) , FIM ( P = 0.021 ) , time ( P = 0.008 ) , and peak ( P = 0.018 ) , were significantly higher in the RFVE group after treatment , but not speed ( P = 0.140 ) .


The patients affected by hemorrhagic stroke significantly improved FIM ( P = 0.031 ) , time ( P = 0.011 ) , and peak ( P = 0.020 ) after treatment , whereas the patients affected by ischemic stroke improved significantly only speed ( P = 0.005 ) when treated by RFVE .


These results indicated that some poststroke patients may benefit from RFVE program for the recovery of upper limb motor function .


This trial is registered with NCT01955291 .


Differences in manifestation , treatment , and outcomes of acute heart failure between men and women have not been well studied .


The objective of this analysis was to characterize differences in clinical presentation , and in-hospital and post-discharge outcomes between sexes in acute heart failure patients .


Clinical profiles , treatment characteristics , and outcomes were compared between sexes in 2033 patients hospitalized for acute heart failure and impaired renal function .


Women comprised 33 % of the study population and were older , had higher body mass index , LVEF , and systolic blood pressure , and a greater prevalence of diabetes .


At baseline , women showed signs and symptoms of congestion comparable with men , but more often had rales , orthopnoea , and worse renal function .


Women were less intensively diuresed , as indicated by lower oral and intravenous diuretic doses used , fewer dose increases , and less total weight loss during hospitalization .


Furthermore , hospitalization was slightly but significantly prolonged in women ( 11.04 7.8 vs. 10.65 8.86 days ; P = 0.024 ) .


Age-adjusted 180-day mortality was lower in women ( 15.8 % vs. 18.5 % , hazard ratio 0.74 ; 95 % confidence interval 0.59-0 .93 , P = 0.010 ) , but multivariable risk-adjusted mortality was similar in both sexes , mainly attributable to lower blood urea nitrogen , higher LVEF , and higher systolic blood pressure in women compared with men .


Women with acute heart failure present with a clinical profile different from that of men , with more hypertension , diabetes , and depression , and a preserved LVEF .


During hospitalization , they were less intensively diuresed .


Nevertheless , risk-adjusted 180-day outcome was similar between sexes .


The purpose of this study was to compare the efficacy of percutaneous aspiration thrombectomy ( PAT ) followed by standard anticoagulant therapy , with anticoagulation therapy alone , for the treatment of acute proximal lower extremity deep vein thrombosis .


In this randomised , prospective study , 42 patients with acute proximal iliofemoral deep vein thrombosis documented via Doppler ultrasound examination , were separated into an interventional treatment group ( 16 males , 5 females , average age 51years ) and a medical treatment group ( 13 males , 8 females , average age 59years ) .


In the interventional group , PAT with large-lumen 9-F diameter catheterisation was applied , after initiation of standard anticoagulant therapy .


Balloon angioplasty ( n 19 ) and stent implementation ( n : 14 ) were used to treat patients with residual stenosis ( > 50 % ) after PAT .


Prophylactic IVC filters were placed in two patients .


The thrombus clearance status of the venous system was evaluated by venography .


In both the medical and interventional groups , venous patency rates and clinical symptom scores were evaluated at months 1 , 3 , and 12 after treatment .


Deep venous systems became totally cleared of thrombi in 12 patients treated with PAT .


The venous patency rates in month 12 were 57.1 and 4.76 % in the interventional and medical treatment groups , respectively .


A statistically significant improvement was observed in clinical symptom scores of the interventional group ( PAT ) with or without stenting ( 4.230.51 before treatment ; 0.810.92 at month 12 ) compared with the medical treatment group ( 4.000.63 before treatment ; 2.430.67 at month 12 ) .


During follow-up , four patients in the medical treatment and one in the interventional group developed pulmonary embolisms .


For treatment of acute deep vein thrombosis , PAT with or without stenting is superior to anticoagulant therapy alone in terms of both ensuring venous patency and improving clinical symptoms .


PAT is a safe , inexpensive , and easily performed method of endovascular treatment with a low rate of major complications .


Our present findings and literature data suggest that PAT can be used as first-line treatment in proximal deep vein thrombosis patients , especially when thrombolytic treatment is contraindicated .


To explore a more optimal therapy for chronic prostatitis .


Ninty cases of chronic prostitis were randomized into a warming-promoting needling and target penetrating needling method group ( WT group ) , a conventional acupuncture group ( CA group ) and a medication group ( M group ) , 30 cases in each one .


The warming-promoting needling method was applied at Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Qihai ( CV 6 ) , Daheng ( SP 15 ) , Qichong ( ST 30 ) in the WT group , the needling sensation was targeted towards the prostate , once daily ; in CA group , conventional acupuncture was applied at the same acupoints of WT group ; Qianliekang tablets was prescribed to the M group .


For the 3 groups , 10 treatment made one session and 3 days as an interval , the efficacy was evaluated after 3 sessions .


All of the 3 methods were effective for chronic prostitis , the total effective rate in the WT group was 93.3 % ( 28/30 ) , which was superior to 73.3 % ( 22/30 , P < 0.05 ) in the CA group and 63.3 % ( 19/30 , P < 0.01 ) in the M group .


The curative rate in the WT group was 80.0 % ( 24/30 ) , which was superior to 46.6 % ( 14/30 ) in the CA group and 30.0 % ( 9/30 ) in the M group ( both P < 0.001 ) .


The warming-promoting needling and target penetrating needling method achieve superior efficacy on chronic prostatitis as compared with conventional acupuncture and Qianliekang tablets .


In the American College of Surgeons National Surgical Quality Improvement Program ( ACS NSQIP ) , pancreatic fistula has not been monitored , although organ space infection ( OSI ) data are collected .


Therefore , the purpose of this analysis was to determine the relationship between ACS NSQIP organ space infection and pancreatic fistulas .


From 2007 to 2011 , 976 pancreatic resection patients were monitored via ACS NSQIP at our institution .


From this database , 250 patients were randomly chosen for further analysis .


Four patients were excluded because they underwent total pancreatectomy .


Data on OSI were gathered prospectively .


Data on pancreatic fistulas and other intra-abdominal complications were determined retrospectively .


Organ space infections ( OSIs ) were documented in 22 patients ( 8.9 % ) .


Grades B ( n = 26 ) and C ( n = 5 ) pancreatic fistulas occurred in 31 patients ( 12.4 % ) ; grade A fistulas were observed in 38 patients ( 15.2 % ) .


Bile leaks and gastrointestinal ( GI ) anastomotic leaks each developed in 5 ( 2.0 % ) patients .


Only 17 of 31 grade B and C pancreatic fistulas ( 55 % ) , and none of 38 grade A fistulas were classified as OSIs in ACS NSQIP .


In addition , only 2 of 5 bile leaks ( 40 % ) and 2 of 5 GI anastomotic leaks ( 40 % ) were OSIs .


Moreover , 3 OSIs were due to bacterial peritonitis , a chyle leak , and an ischemic bowel .


This analysis suggests that the sensitivity ( 55 % ) and specificity ( 45 % ) of organ space infection ( OSI ) in ACS NSQIP are too low for OSI to be a surrogate for grade B and C pancreatic fistulas .


We concluded that procedure-specific variables will be required for ACS NSQIP to improve outcomes after pancreatectomy .


To evaluate feasibility , safety , and efficacy of overnight closed-loop insulin delivery in free-living youth with type 1 diabetes .


Overnight closed loop was evaluated at home by 16 pump-treated adolescents with type 1 diabetes aged 12-18 years .


Over a 3-week period , overnight insulin delivery was directed by a closed-loop system , and on another 3-week period sensor-augmented therapy was applied .


The order of interventions was random .


The primary end point was time when adjusted sensor glucose was between 3.9 and 8.0 mmol/L from 2300 to 0700 h.


Closed loop was constantly applied over at least 4 h on 269 nights ( 80 % ) ; sensor data were collected over at least 4 h on 282 control nights ( 84 % ) .


Closed loop increased time spent with glucose in target by a median 15 % ( interquartile range -9 to 43 ; P < 0.001 ) .


Mean overnight glucose was reduced by a mean 14 ( SD 58 ) mg/dL ( P < 0.001 ) .


Time when glucose was < 70 mg/dL was low in both groups , but nights with glucose < 63 mg/dL for at least 20 min were less frequent during closed loop ( 10 vs. 17 % ; P = 0.01 ) .


Despite lower total daily insulin doses by a median 2.3 ( interquartile range -4.7 to 9.3 ) units ( P = 0.009 ) , overall 24-h glucose was reduced by a mean 9 ( SD 41 ) mg/dL ( P = 0.006 ) during closed loop .


Unsupervised home use of overnight closed loop in adolescents with type 1 diabetes is safe and feasible .


Glucose control was improved during the day and night with fewer episodes of nocturnal hypoglycemia .


To evaluate the long-term outcomes of thin-flap laser in situ keratomileusis ( LASIK ) in eyes with thin corneas ( central corneal thickness [ CCT ] < 500 m ) but normal topography .


Private center , Tokyo , Japan .


Retrospective randomized comparative study .


The efficacy , safety , predictability , and topography of LASIK were evaluated in eyes with a CCT of less than 500 m but with normal topography ( thin-cornea group ) to 6 years postoperatively .


The LASIK outcomes in the thin-cornea group were compared with those in eyes with a CCT of 500 m or greater ( control group ) .


Analysis was performed to determine whether there were differences between the groups at the last checkup 3 to 4 years postoperatively .


In the thin-cornea group ( 291 eyes ; 146 patients ) , no significant differences were observed in LASIK outcomes when eyes were subdivided by the time of final checkup ( 3 , 4 , and 5 years ) .


There was a significant difference in visual and refractive outcomes between 3 months postoperatively and the last checkup in the thin-cornea group and the control group ( 371 eyes ; 193 patients ) .


No significant difference in visual , refractive , or topography outcomes was observed between the 2 groups at the last checkup .


Laser in situ keratomileusis in eyes with thin corneas was as safe and effective as and showed similar long-term stability in eyes with a CCT of 500 m or greater .


No eye in either group had a postoperative complication .


No author has a financial or proprietary interest in any material or method mentioned .


Skin-to-skin contact reduces pain response in preterm infants subjected to minor painful procedures , such as heel lance .


Diaper change is a procedure performed several times daily in hospitalized preterm infants .


Routine care giving tasks such as diaper change may be stressful for the infant .


The purpose of this study was to investigate whether diaper change induces stress and if skin-to-skin contact could reduce such stress , measured by changes in skin conductance .


This was a randomized crossover pilot study in 19 preterm infants with gestational age between 28 and 34 weeks .


The diaper change procedure was done twice in each infant , once during skin-to-skin contact , and once in incubator or bed with the mother present .


During diaper change heart rate ( HR ) , peripheral oxygen saturation ( SpO2 ) , and changes in skin conductance ( SC ) peaks per sec , using the Skin Conductance Algesimeter ( SCA ) , were registered .


The mean SC peaks/sec increased/decreased significantly under/after change of diapers which thereby underpins that this is a stressful procedure for the preterm infant .


Skin-to-skin contact ( SSC ) entails significantly lower stress levels ( p < 0.05 ) compared to diaper changed in an incubator/bed measured by the SCA .


Diaper change is a stressful procedure for preterm infants and may be ameliorated by skin-to-skin contact .