Over a median @ years of follow-up , patients with both troponins above the median had significantly higher risk for stroke/systemic embolism -LSB- hazard ratio ( HR ) @ ( @ % CI @-@ @ ) -RSB- , cardiac death -LSB- @ ( @-@ @ ) -RSB- , and myocardial infarction -LSB- @ ( @-@ @ ) -RSB- than those with both troponins below median ( all P < @ ) .


Intermediate risks were observed when only @ troponin was above the median .


When combined with clinical information , each marker provided similar prognostication and had comparable c-index .


cTnI and cTnT concentrations are moderately correlated and measurable in plasma of most AF patients .


The risk of stroke and cardiovascular events is highest when both troponins are above median concentrations .


Each troponin provides comparable prognostic information when combined with clinical risk factors .


ClinicalTrials.gov / NCT@ .


The aim of this study was to evaluate the effects and safety of a sleep aid for postoperative analgesia in patients undergoing arthroscopic rotator cuff repair .


Seventy-eight patients were prospectively assigned to either the zolpidem group ( multimodal analgesia + zolpidem ; @ patients ) or the control group ( multimodal analgesia ; @ patients ) .


Self-rated pain levels were assessed twice a day using a visual analog scale ( VAS ) .


The need for additional rescue analgesic , duration of functional recovery , and adverse effects were assessed for the first @ days after surgery .


The mean number of times that additional rescue analgesic was required during @ days after surgery was @ in the zolpidem group and @ in the control group , a significant difference .


There were no significant differences between the two groups in mean VAS pain scores during the first @ days after surgery , although the zolpidem group had lower VAS pain scores than the control group .


Additionally , there were no significant differences in duration of functional recovery and adverse effects between the two groups .


The use of zolpidem for analgesia after arthroscopic rotator cuff repair provided a significant reduction in the need for rescue analgesic without increasing adverse effects .


Nevertheless , mean VAS pain scores during the first @ days after surgery did not differ between the zolpidem group and the control group .


Surgical resection plus adjuvant platinum-based chemotherapy is considered standard care for stage II to III non-small-cell lung cancer ( NSCLC ) , but its efficacy is limited , and it involves toxic risks , justifying patient-tailored treatment .


Excision repair cross-complementation group @ ( ERCC@ ) was shown to predict cisplatin-based chemotherapy response ; EGFR mutations were predictive of epidermal growth factor receptor inhibition response .


This prospective randomized phase II trial enrolled @ patients with completely resected non-squamous cell stage II or IIIA ( non-N@ ) tumors .


Patients in the control arm ( n = @ ) were treated with four standard-dose courses of cisplatin plus pemetrexed ( CP ) .


In the customized treatment arm ( n = @ ) , patients with activated EGFR mutations received erlotinib @ mg for @ year ; ERCC@-negative patients received four CP courses , whereas ERCC@-positive patients underwent follow-up .


The trial sought to demonstrate the feasibility of customized adjuvant chemotherapy based on timely biomarker analysis within a @-month postsurgery delay .


Secondary objectives were tolerability , compliance with adjuvant therapy , and biomarker distribution .


In arm A , all patients received CP ; in arm B , seven received erlotinib , @ were administered CP , and @ underwent follow-up .


Median erlotinib exposure was @ days .


Of the @ patients allocated to CP , @ % received four cycles with good tolerability .


The overall success rate of the trial ( ie , percentage of patients with complete biomarker status able to start adjuvant treatment within @ months of surgery ) was @ % .


The primary end point of the trial was met , demonstrating the feasibility of a national biology-driven trial in the adjuvant NSCLC setting .


Nevertheless , the phase III part was canceled because of the unreliability of the ERCC@ immunohistochemical readouts .


The phosphodiesterase inhibitors are used in the treatment of ED and there are increasing data of effects of these drugs on bladder and urethral relaxation as well as of prostatic smooth muscles that may relief the symptoms of BPH .


This study was conducted to evaluate the role of Tadalafil ( a PDE-@ inhibitor ) in combination with standard therapy for the treatment of BPH .


In this randomized clinical trial of @ patients with obstructive and irritative urinary tract symptoms due to BPH , IPSS @ , Iief @ , Q-max from @ mL/s to @ mL/s and residual urine volume ( RUV ) < @ mL , there was indication for surgical intervention .


These patients were randomly allocated in three groups .


Each patient received a therapeutic treatment daily for @ weeks .


Group A received treatment with tamsulosin @ mg and tadalafil @ mg , Group B received a standard treatment with tamsulosin @ mg for BPH and Group C received only one treatment with tadalafil @ mg .


There was no significant difference in terms of IPSS score , Qmax and RUV before treatment in the three groups tested .


Analysis of the data shows that in patients treated with tamsulosin and tadalafil IPSS , IIEF and QoL were significantly improved in a different way than in the other two groups , while the Qmax and RUV did not show a significant change in the three groups , remaining almost constant .


The PDE-@ inhibitor improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH , but does n't have any significant effect on Qmax and RUV .


This article presents the results of research based on the feelings and responses of members of a sports club , in relation to a fitness programme offered by Fitness World .


The study consisted of a group of @ participants chosen at random .


Statistically , the analysed results of the research show that the biggest group attending Fitness World consists of men between @ and @ years of age with higher education , and women between @ and @ with , mostly , higher education .


In general , men prefer to participate in aerobics group sessions and gym sessions , and women choose to take part in any activities .


The most preferred time was between @ p.m. and @ p.m. , usually after work , and with a frequency of twice a week .


It was not possible to determine the main reasons for motivation , although @ % prefer to practise regularly .


To generate comparative clinical data in Indian patients with acute coronary syndrome ( ACS ) in terms of safety and efficacy of atorvastatin @ mg vis -- vis atorvastatin @ mg


A total of @ patients with diagnosed ACS ( with TIMI Risk score > or = @ ) within preceding @ days were randomized to receive either atorvastatin @ mg or atorvastatin @ mg once daily for @ weeks .


Out of @ patients , data for @ was analyzed who had both baseline and post-baseline lipid assessment .


The primary end point of the trial was percentage change in LDL-C at the end of treatment from baseline .


Other end points were change in high sensitivity C reactive protein , incidence of increase in liver enzymes > or = @ times upper limit of normal and incidence of myotoxicity ( with or without elevation of creatinine phosphokinase ) at the end of treatment .


A dose-dependent response was observed with greater reduction of LDL - C in atorvastatin @ mg ( @ % vs @ % ) than that of atorvastatin @ mg group .


Both the treatment groups had a significant reduction ( p < @ ) in LDL-C at the end of @ and @ weeks in comparison to baseline .


hs-CRP was also significantly reduced ( p < @ ) in both the treatment groups i.e. atorvastatin @ mg ( @ % ) and atorvastatin @ mg ( @ % ) from baseline at the end of @ weeks .


Both doses of atorvastatin were well tolerated .


No patient had elevation of ( > or = @ times of upper limit of normal ) liver enzymes or creatinine phosphokinase .


One patient on atorvastatin @ mg complained of myalgia .


There were no dose-related differences in incidence of adverse events between two treatment groups .


The CURE-ACS trial indicated that atorvastatin @ mg was more effective than atorvastatin @ mg in terms of reduction in LDL cholesterol and was as safe and well tolerated as @ mg dose in Indian patients with ACS .


With high-fidelity simulators in a modern blended learning setting , students are able to acquire knowledge and practical skills in acute medicine in realistic scenarios .


However , it has not yet been clarified if the sequence of linking between knowledge and simulator-based training of practical skills plays an important role for increasing knowledge , for the self-concept and learning emotions of trainees .


In a pilot study the influence of the type of knowledge acquisition under two independent conditions was investigated in which the order of presenting the learning material ( firstly theory and then simulation vs. simulation elements before the theory ) was reversed .


In addition the influence of individual attributes of personality on the construction of situated knowledge was correlated with these conditions in two groups .


To investigate the outcome of simulator-based learning @ students were randomly allocated to one of the two conditions and undertook two scenarios ( anaphylactic shock and myocardial infarction ) , whereby the theoretical lessons were given either before or after the scenarios .


Using standardized questionnaires and problem-centered semi-standardized interviews , the following variables of the participants were assessed : personality traits , current positive and negative feelings , professional self-concept , general self-efficacy and coping strategies for stress .


Theoretical knowledge and practical skills were assessed using a knowledge test and standardized assessment questionnaires which also focused on performance and patient safety .


All together the results showed a slight advantage for the condition of theory before simulation which was not determined by the acquisition of knowledge but by a better performance of trainees as assessed by the trainers .


Regarding knowledge acquisition , no statistically significant differences could be shown .


Significant differences ( p < @ ) were found for negative feelings ( very intense negative emotional state ) and for the professional self-concept ( perception of own professional skills ) in favor of the theory then simulation condition .


More extrovert participants showed poorer results which could not be attributed to one of the conditions .


However , the participants always assessed the allocated learning condition as the best premise for effective learning outcome .


Reaction to stress has been described as `` jumping in at the deep end '' as well as the lasting effect on learning from errors .


In the context of simulation-based teaching , the learning outcome not only depends on knowledge , practical skills and motivational variables but also on the presence of negative feelings , ability self-concepts and various personality traits .


There was a trend which showed that simulation in the field of anesthesiology and emergency medicine should be set up with the theoretical basis first in order to avoid negative feelings .


To evaluate the relative efficacy and safety of extended-release tramadol HCl @mg/acetaminophen @mg ( TA-ER ) and immediate-release tramadol HCl @ mg/acetaminophen @mg ( TA-IR ) for the treatment of moderate to severe acute pain following total knee replacement .


This phase III , double-blind , placebo-controlled , parallel-group study randomized @ patients with moderate to severe pain ( @ intensity on an @ point numeric rating scale ) following total knee replacement arthroplasty to receive oral TA-ER ( every @ hours ) or TA-IR ( every @ hours ) over a period of @ hours .


In the primary analysis , TA-ER was evaluated for efficacy non-inferior to that of TA-IR based on the sum of pain intensity difference ( SPID ) at @ hours after the first dose of study drug ( SPID@ ) .


Secondary endpoints included SPID at additional time points , total pain relief at all on-therapy time points ( TOTPAR ) , sum of SPID and TOTPAR at all on-therapy time points ( SPID+TOTPAR ) , use of rescue medication , subjective pain assessment ( PGIC , Patient Global Impression of Change ) , and adverse events ( AEs ) .


Analysis of the primary efficacy endpoint ( SPID@ ) could not establish the non-inferiority of TA-ER to TA-IR .


However , a post hoc analysis with a re-defined non-inferiority margin did demonstrate the non-inferiority of TA-ER to TA-IR .


No statistically significant difference in SPID at @ , @ , or @ hours was observed between the TA-ER and TA-IR groups .


Similarly , analysis of TOTPAR showed that there were no significant differences between groups at any on-therapy time point , and SPID+TOTPAR at @ and @ hours were similar among groups .


There was no difference in the mean frequency or dosage of rescue medication required by both groups , and the majority of patients in both the TA-ER and TA-IR groups rated their pain improvement as ` much ' or ` somewhat better ' .


The overall incidence of @ AEs was similar among the TA-ER ( @ % ) and TA-IR ( @ % ) groups .


The most commonly reported AEs by patients treated with TA-ER and TA-IR included nausea ( @ % vs @ % ) , vomiting ( @ % vs @ % ) , and decreased hemoglobin ( @ % vs @ % ) .


This study is limited by the lack of placebo control , and the invalidity of the initial non-inferiority margin .


This study demonstrated that the analgesic effect of TA-ER is non-inferior to TA-IR , and supports TA-ER as an effective and safe treatment for moderate to severe acute pain post total knee replacement .


Methotrexate is a first-line systemic agent for treating of psoriasis , although its onset of effects is slower and overall it is less effective than tumor necrosis factor blockers .


To differentiate the response of psoriatic disease to adalimumab and methotrexate sodium .


Single-center , randomized , assessor-blind , @-arm clinical trial of @ patients from the outpatient dermatology center of Tufts Medical Center , enrolled from August @ , @ , to October @ , @ .


Patients aged @ to @ years with chronic plaque-type psoriasis , a minimum Physician Global Assessment score of @ ( higher scores indicate more severe disease ) , and a psoriatic plaque of at least @ cm were randomized in a @:@ fashion to receive subcutaneous adalimumab or oral methotrexate .


Skin biopsy specimens obtained at baseline and weeks @ , @ , @ , and @ were given a histologic grade by blinded assessors to evaluate treatment response .


Analyses were conducted from April @ , @ , to January @ , @ .


A @-week course of subcutaneous adalimumab ( @ mg every @ weeks after a loading dose ) or low-dosage oral methotrexate sodium ( @-@ mg/wk ) .


Changes in genomic , immunohistochemical , and messenger RNA ( mRNA ) profiles .


Methotrexate responders experienced significant downregulation of helper T-cell-related ( T ( H ) @ , T ( H ) @ , and T ( H ) @ ) mRNA expression compared with methotrexate nonresponders .


Comparisons among adalimumab-treated patients were limited by the number of nonresponders ( n = @ ) .


Between adalimumab and methotrexate responders , we found no significant differences in gene expression at any study point or in the expression of T-cell-related mRNA at week @ .


Adalimumab responders demonstrated early downregulation of chemokine ( C-C motif ) ligand @ ( CCL@ ) mRNA ( mean -LSB- SE -RSB- at week @ , -@ -LSB- @ -RSB- , P < @ ; week @ , -@ -LSB- @ -RSB- , P < @ ) compared with late downregulation for methotrexate responders ( week @ , @ -LSB- @ -RSB- , P = @ ; week @ , -@ -LSB- @ -RSB- , P < @ ) .


Similar differences were observed with interleukin @ ( IL@ ) mRNA showing early downregulation for adalimumab responders ( week @ , -@ -LSB- @ -RSB- , P < @ ; week @ , -@ -LSB- @ -RSB- , P < @ ) compared with late downregulation for methotrexate responders ( week @ , -@ -LSB- @ -RSB- , P = @ ; week @ , -@ -LSB- @ -RSB- , P < @ ) .


Analysis of variance findings for key mRNA and immunohistochemical marker expression over the study course were significant only for CCL@ ( P = @ ) and IL@ ( P = @ ) mRNA comparing adalimumab and methotrexate responders .


Methotrexate is an immunomodulator with effects on helper T-cell signaling in psoriasis .


Similar genomic and immunohistochemical response signatures and levels of mRNA downregulation at study completion among adalimumab and methotrexate responders suggest a disease-driven instead of therapeutic-driven pathway regulation .


Adalimumab and methotrexate responses are differentiated by patterns of normalization of CCL@ and IL@ mRNA expression and may explain the varied onset and degree of clinical responses by each treatment .


The need to prevent reflux in the construction of an orthotopic ileal neobladder is controversial .


We designed the USC-STAR trial to determine whether the T-pouch neobladder that included an antireflux mechanism was superior to the Studer pouch in patients with bladder cancer undergoing radical cystectomy .


This single center , randomized , controlled trial recruited patients with clinically nonmetastatic bladder cancer scheduled to undergo radical cystectomy with neobladder .


Eligible patients were randomly assigned to undergo T-pouch or Studer ileal orthotopic neobladder .


Treatment assignment was not masked .


The primary end point was change in renal function from baseline to @ years .


The CKD-EPI ( Chronic Kidney Disease Epidemiology Collaboration ) equation was used to calculate the estimated glomerular filtration rate .


Between February @ and November @ , @ patients were randomly assigned to T-pouch ileal orthotopic neobladder and @ to Studer ileal orthotopic neobladder .


Baseline characteristics did not differ between the groups .


Between baseline and @ years the estimated glomerular filtration rate decreased by @ ml/minute/@ @ m ( @ ) in the Studer group and @ ml/minute/@ @ m ( @ ) in the T-pouch group ( p = @ ) .


Multivariable analysis showed that type of ileal orthotopic neobladder was not independently associated with @-year renal function ( p = @ ) .


However , baseline estimated glomerular filtration rate , age and urinary tract obstruction were independently associated with @-year decline in renal function .


Cumulative risk of urinary tract infection and overall late complications were not different between the groups , but the T-pouch was associated with an increased risk of secondary diversion related surgeries .


T-pouch ileal orthotopic neobladder with an antireflux mechanism did not prevent a moderate reduction in renal function observed at @ years compared to the Studer pouch , but did result in an increase in diversion related secondary surgical procedures .


Facial affect recognition , a basic building block of social cognition , is often impaired in schizophrenia .


Poor facial affect recognition is closely related to poor functional outcome ; however , neither social cognitive impairments nor functional outcome are sufficiently improved by antipsychotic drug treatment alone .


Adjunctive repetitive transcranial magnetic stimulation ( rTMS ) has been shown to enhance cognitive functioning in both healthy individuals and in people with neuropsychiatric disorders and to ameliorate clinical symptoms in psychiatric disorders , but its effects on social cognitive impairments in schizophrenia have not yet been studied .


Therefore , we evaluated the effects of sham-controlled rTMS on facial affect recognition in patients with chronic schizophrenia .


Inpatients ( N = @ ) on stable antipsychotic treatment were randomly assigned to double-blind high-frequency ( @ Hz ) rTMS or sham stimulation for a total of ten sessions over two weeks .


In the verum group , each session consisted of @ @ stimuli ( @ trains of @ s ) applied over the left dorsolateral prefrontal cortex at @ % of motor threshold .


Facial affect recognition was assessed before ( T@ ) and after ( T@ ) the ten sessions .


Facial affect recognition improved significantly more after rTMS ( accuracy change : mean = @ % , SD = @ % ) than after sham stimulation ( mean = @ % , SD = @ ; Cohen 's d = @ ) .


There was no correlation with clinical improvement .


Our results indicate that prefrontal @ Hz rTMS stimulation may help to ameliorate impaired facial affect recognition in schizophrenia .


Early clinical studies suggested that the anti-interleukin-@ receptor A monoclonal antibody brodalumab has efficacy in the treatment of psoriasis .


In two phase @ studies ( AMAGINE-@ and AMAGINE-@ ) , patients with moderate-to-severe psoriasis were randomly assigned to receive brodalumab ( @ mg or @ mg every @ weeks ) , ustekinumab ( @ mg for patients with a body weight @ kg and @ mg for patients > @ kg ) , or placebo .


At week @ , patients receiving brodalumab were randomly assigned again to receive a brodalumab maintenance dose of @ mg every @ weeks or @ mg every @ weeks , every @ weeks , or every @ weeks ; patients receiving ustekinumab continued to receive ustekinumab every @ weeks , and patients receiving placebo received @ mg of brodalumab every @ weeks .


The primary aims were to evaluate the superiority of brodalumab over placebo at week @ with respect to at least a @ % reduction in the psoriasis area-and-severity index score ( PASI @ ) and a static physician 's global assessment ( sPGA ) score of @ or @ ( clear or almost clear skin ) , as well as the superiority of brodalumab over ustekinumab at week @ with respect to a @ % reduction in PASI score ( PASI @ ) .


At week @ , the PASI @ response rates were higher with brodalumab at the @-mg and @-mg doses than with placebo ( @ % and @ % , respectively , vs. @ % -LSB- AMAGINE-@ -RSB- and @ % and @ % , respectively , vs. @ % -LSB- AMAGINE-@ -RSB- ; P < @ ) ; the rates of sPGA scores of @ or @ were also higher with brodalumab ( P < @ ) .


The week @ PASI @ response rates were significantly higher with @ mg of brodalumab than with ustekinumab ( @ % vs. @ % -LSB- AMAGINE-@ -RSB- and @ % vs. @ % -LSB- AMAGINE-@ -RSB- , P < @ ) .


The PASI @ response rates with @ mg of brodalumab were @ % in AMAGINE-@ ( P = @ for the comparison with ustekinumab ) and @ % in AMAGINE-@ ( P = @ ) .


Rates of neutropenia were higher with brodalumab and with ustekinumab than with placebo .


Mild or moderate candida infections were more frequent with brodalumab than with ustekinumab or placebo .


Through week @ , the rates of serious infectious episodes were @ ( AMAGINE-@ ) and @ ( AMAGINE-@ ) per @ patient-years of exposure to brodalumab .


Brodalumab treatment resulted in significant clinical improvements in patients with moderate-to-severe psoriasis .


( Funded by Amgen ; AMAGINE-@ and AMAGINE-@ ClinicalTrials.gov numbers , NCT@ and NCT@ . )


The significance of basal renal nitric oxide ( NO ) availability in the regulation of renal perfusion and sodium excretion in human congestive heart failure ( CHF ) has not been described previously .


We studied the effects of acute systemic NO synthesis inhibition with N ( G ) - monomethyl-L-arginine ( L-NMMA ) in @ patients with CHF and @ healthy control subjects ( CON ) in a randomized placebo-controlled study .


Effect parameters were renal plasma flow ( RPF ) , renal vascular resistance ( RVR ) , glomerular filtration rate ( GFR ) , urine sodium excretion and plasma levels of vasoactive hormones .


L-NMMA was associated with a significant decrease in RPF ( CON-LNMMA : -@ @ % -LSB- P = @ -RSB- ; CHF-LNMMA : -@ @ % -LSB- P = @ -RSB- ) and a profound increase in RVR in both CHF and CON ( CON-LNMMA : +@ @ % -LSB- P = @ -RSB- ; CHF-LNMMA : +@ @ % -LSB- P = @ -RSB- ) .


Significant decreases in sodium excretion were found in both CHF-LNMMA and CON-LNMMA .


Relative changes from baseline were not statistically different between CHF-LNMMA and CON-LNMMA .


After L-NMMA , RPF values correlated inversely with plasma aldosterone in CHF-LNMMA ( P = @ ) .


L-NMMA induced an increase in A-type natriuretic peptide ( ANP ) only in CHF-LNMMA ( +@ @ % ; P = @ ) , which correlated significantly with basal ANP levels ( P = @ ) .


There was no difference in the renal response to L-NMMA in CHF vs CON , suggesting that the impact of NO on renal perfusion and sodium excretion is maintained in stable CHF .


We suggest that NO influences the release of ANP during high levels of atrial stretch in CHF .


Adipose-derived regenerative cells ( ADRCs ) can be isolated from liposuction aspirates and prepared as fresh cells for immediate administration in cell therapy .


We performed the first randomized , placebo-controlled , double-blind trial to examine the safety and feasibility of the transendocardial injections of ADRCs in no-option patients with ischemic cardiomyopathy .


Procedural , postoperative , and follow-up safety end points were monitored up to @ months .


After baseline measurements , efficacy was assessed by echocardiography and single-photon emission computed tomography ( @ , @ , and @ months ) , metabolic equivalents and maximal oxygen consumption ( MVO@ ) ( @ and @ months ) , and cardiac magnetic resonance imaging ( @ months ) .


We enrolled @ ADRC-treated and @ control patients .


Liposuction was well tolerated , ADRCs were successfully prepared , and transendocardial injections were feasible in all patients .


No malignant arrhythmias were seen .


Adverse events were similar between groups .


Metabolic equivalents and MVO@ values were preserved over time in ADRC-treated patients but declined significantly in the control group .


The difference in the change in MVO@ from baseline to @ and @ months was significantly better in ADRC-treated patients compared with controls .


The ADRC-treated patients showed significant improvements in total left ventricular mass by magnetic resonance imaging and wall motion score index .


Single-photon emission computed tomography results suggested a reduction in inducible ischemia in ADRC-treated patients up to @ months .


Isolation and transendocardial injection of autologous ADRCs in no-option patients were safe and feasible .


Our results suggest that ADRCs may preserve ventricular function , myocardial perfusion , and exercise capacity in these patients .


The treatment of cancer patients with mistletoe extract is said to prolong their survival and , above all , improve their quality of life .


We studied whether the quality of life of patients with advanced pancreatic cancer could be improved by mistletoe extract .


An open , single-center , group-sequential , randomized phase III trial ( ISRCTN@ ) was conducted .


From January @ to December @ , @ patients with locally advanced or metastatic pancreatic cancer who were receiving no further treatment for pancreatic cancer other than best supportive care were included in this trial .


They were stratified by prognosis and randomly allocated either to a group that received mistletoe treatment or to one that did not .


Mistletoe extract was given in escalating doses by subcutaneous injection three times a week .


The planned interim evaluation of data from @ patients indicated that mistletoe treatment was associated with longer overall survival , and the trial was terminated prematurely .


After termination of the study , the results with respect to quality of life ( assessed with the QLO-C@ scales of the European Organisation for Research and Treatment of Cancer ) and trends in body weight were evaluated .


Data on quality of life and body weight were obtained from @ patients treated with mistletoe and @ control patients .


Those treated with mistletoe did better on all @ functional scales and on @ of @ symptom scales , including pain ( @ % confidence interval -LSB- CI -RSB- -@ to -@ ) , fatigue ( @ % CI -@ to -@ ) , appetite loss ( @ % CI -@ to -@ ) , and insomnia ( @ % CI -@ to -@ ) .


This is reflected by the trend in body weight during the trial .


In patients with locally advanced or metastatic pancreatic carcinoma , mistletoe treatment significantly improves the quality of life in comparison to best supportive care alone .


Mistletoe is an effective second-line treatment for this disease .


Immunohistochemical assessment of liver tissue in chronic delta hepatitis ( CDH ) is underinvestigated .


Aim of the study was ( i ) to assess variables associated with hepatitis D antigen ( HDAg ) , hepatitis B surface antigen ( HBsAg ) and hepatitis B core antigen ( HBcAg ) staining in the liver .


Demographic , biochemical and virologic data collected from the HIDIT @ study were used .


HBsAg , HBcAg and HDAg immunohistochemical ( IHC ) staining was semiquantitatively assessed .


Hepatitis D antigen immunohistochemical staining displayed positive correlations with age and alanine aminotransferase ( ALT ) and negative correlations with serum HBsAg ( P = @ for all ) .


HBsAg IHC displayed a negative correlation with gamma glutamyl transferase and positive correlations with serum HBV DNA , serum HBsAg levels and HBeAg serology ( P < @ , P = @ and P = @ respectively ) .


HBcAg staining was mainly nuclear and displayed negative correlations with serum HBsAg and histologic activity ( P = @ and P = @ respectively ) .


Pegylated IFN based treatment led to a decline of all IHC markers , however , these markers had no impact on treatment outcome .


These data suggest an association of liver injury with HDAg expression in CDH whereas the negative correlation between HBcAg expression and liver injury and the overall nuclear localization of HBcAg suggest that HBcAg does not contribute to liver injury in CDH .


HDV cases with high level of HBV replication , high serum HBsAg levels , HBeAg positivity , that are probably in the earlier stages of disease ( low gamma-glutamyl transferase ) , had a more intense HBsAg staining profile .


Overall , the data enforce the importance of HDAg and HBsAg in different phases of CDH infection .


The traditional treatment for primary anterior shoulder dislocations has been immobilization in a sling with the arm in a position of adduction and internal rotation .


However , recent basic science and clinical data have suggested recurrent instability may be reduced with immobilization in external rotation after primary shoulder dislocation .


We performed a randomized controlled trial to compare the ( @ ) frequency of recurrent instability and ( @ ) disease-specific quality-of-life scores after treatment of first-time shoulder dislocation using either immobilization in external rotation or immobilization in internal rotation in a group of young patients .


Sixty patients younger than @ years of age with primary , traumatic , anterior shoulder dislocations were randomized ( concealed , computer-generated ) to immobilization with either an internal rotation sling ( n = @ ) or an external rotation brace ( n = @ ) at a mean of @ days after closed reduction ( range , @-@ days ) .


Patients with large bony lesions or polytrauma were excluded .


The two groups were similar at baseline .


Both groups were immobilized for @ weeks with identical therapy protocols thereafter .


Blinded assessments were completed by independent observers for a minimum of @ months ( mean , @ months ; range , @-@ months ) .


Recurrent instability was defined as a second documented anterior dislocation or multiple episodes of shoulder subluxation severe enough for the patient to request surgical stabilization .


Validated disease-specific quality-of-life data ( Western Ontario Shoulder Instability index -LSB- WOSI -RSB- , American Shoulder and Elbow Surgeons evaluation -LSB- ASES -RSB- ) were also collected .


Ten patients ( @ % , five from each group ) were lost to followup .


Reported compliance with immobilization in both groups was excellent ( @ % ) .


With the numbers available , there was no difference in the rate of recurrent instability between groups : @ of @ patients ( @ % ) with the external rotation brace versus @ of @ patients ( @ % ) with the sling redislocated or developed symptomatic recurrent instability ( p = @ ) .


WOSI scores were not different between groups ( p = @ ) and , although the difference in ASES scores approached statistical significance ( p = @ ) , the magnitude of this difference was small and of uncertain clinical importance .


Despite previous published findings , our results show immobilization in external rotation did not confer a significant benefit versus sling immobilization in the prevention of recurrent instability after primary anterior shoulder dislocation .


Further studies with larger numbers may elucidate whether functional outcomes , compliance , or comfort with immobilization can be improved with this device .


Level I , therapeutic study .


See Instructions for Authors for a complete description of levels of evidence .


We studied the correlation between outer nuclear layer ( ONL ) thickness and cone density in normal eyes and eyes with retinitis pigmentosa ( RP ) .


Spectral-domain optical coherence tomography ( SD-OCT ) scans were acquired using a displaced pupil entry position of the scanning beam to distinguish Henle 's fiber layer from the ONL in @ normal eyes ( @ subjects ) and @ eyes with RP ( @ patients ) .


Cone photoreceptors were imaged using adaptive optics scanning laser ophthalmoscopy .


The ONL thickness and cone density were measured at @ intervals along the horizontal meridian through the fovea nasally and temporally .


The ONL thickness and cone density were correlated using Spearman 's rank correlation coefficient r.


Cone densities averaged over the central @ were lower in eyes with RP than normal , but showed high variability in both groups .


The ONL thickness and cone density were significantly correlated when all retinal eccentricities were combined ( r = @ ) ; the correlation for regions within @ to @ eccentricity was stronger ( r = @ ) than between @ and @ eccentricity ( r = @ ) .


Although cone densities were lower between @ and @ in eyes with RP , ONL thickness measures at identical retinal locations were similar in the two groups ( P = @ ) , and interindividual variation was high for ONL and cone density measures .


Although ONL thickness and retinal eccentricity were important predictors of cone density , eccentricity was over @ times more important .


The ONL thickness and cone density were correlated in normal eyes and eyes with RP , but both were strongly correlated with retinal eccentricity , precluding estimation of cone density from ONL thickness .


( ClinicalTrials.gov number , NCT@ . )


The role of procalcitonin ( PCT ) , a widely used sepsis biomarker , in critically ill patients with sepsis is undetermined .


To investigate the effect of a low PCT cut-off on antibiotic prescription and to describe the relationships between PCT plasma concentration and sepsis severity and mortality .


This was a multicenter ( @ Australian intensive care units -LSB- ICUs -RSB- ) , prospective , single-blind , randomized controlled trial involving @ patients with suspected bacterial infection/sepsis and expected to receive antibiotics and stay in ICU longer than @ hours .


The primary outcome was the cumulative number of antibiotics treatment days at Day @ .


PCT was measured daily while in the ICU .


A PCT algorithm , including @ ng/ml cut-off , determined antibiotic cessation .


Published guidelines and antimicrobial stewardship were used in all patients .


Primary analysis included @ ( PCT ) versus @ standard care patients .


Ninety-three patients in each group had septic shock .


The overall median ( interquartile range ) number of antibiotic treatment days were @ ( @-@ ) versus @ ( @-@ ) , P = @ ; in patients with positive pulmonary culture , @ ( @-@ ) versus @ ( @-@ ) , P = @ ; and in patients with septic shock , @ ( @-@ ) versus @ ( @-@ ) , P = @ ; with an overall @-day all-cause mortality of @ ( @ % ) versus @ ( @ % ) , P = @ in the PCT versus standard care , respectively .


Using logistic regression , adjusted for age , ventilation status , and positive culture , the decline rate in log ( PCT ) over the first @ hours independently predicted hospital and @-day mortality ( odds ratio -LSB- @ % confidence interval -RSB- , @ -LSB- @-@ @ -RSB- , P = @ ; @ -LSB- @-@ @ -RSB- , P = @ , respectively ) .


In critically ill adults with undifferentiated infections , a PCT algorithm including @ ng/ml cut-off did not achieve @ % reduction in duration of antibiotic treatment .


Clinical trial registered with http://www.anzctr.org.au ( ACTRN@ ) .


In contrast to drug-sensitive tuberculosis , the guidelines for the treatment of multi-drug-resistant tuberculosis ( MDR-TB ) have a very poor evidence base ; current recommendations , based on expert opinion , are that patients should be treated for a minimum of @ months .


A series of cohort studies conducted in Bangladesh identified a nine-month regimen with very promising results .


There is a need to evaluate this regimen in comparison with the currently recommended regimen in a randomized controlled trial in a variety of settings , including patients with HIV-coinfection .


STREAM is a multi-centre randomized trial of non-inferiority design comparing a nine-month regimen to the treatment currently recommended by the World Health Organization in patients with MDR pulmonary TB with no evidence on line probe assay of fluoroquinolone or kanamycin resistance .


The nine-month regimen includes clofazimine and high-dose moxifloxacin and can be extended to @ months in the event of delay in smear conversion .


The primary outcome is based on the bacteriological status of the patients at @ months post-randomization .


Based on the assumption that the nine-month regimen will be slightly more effective than the control regimen and , given a @ % margin of non-inferiority , a total of @ patients are required to be enrolled .


Health economics data are being collected on all patients in selected sites .


The results from the study in Bangladesh and cohorts in progress elsewhere are encouraging , but for this regimen to be recommended more widely than in a research setting , robust evidence is needed from a randomized clinical trial .


Results from the STREAM trial together with data from ongoing cohorts should provide the evidence necessary to revise current recommendations for the treatment for MDR-TB .


To determine the effectiveness of part-time patching for treating intermittent exotropia ( IXT ) in young children .


Multicenter , randomized clinical trial .


Two hundred one children @ to @ months of age with untreated IXT meeting the following criteria : ( @ ) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near , and ( @ ) @-prism diopter ( ) or more exodeviation at distance or near by prism and alternate cover test ( PACT ) but at least @ exodeviation at distance by PACT .


Participants were assigned randomly to either observation ( no treatment for @ months ) or patching prescribed for @ hours daily for @ months , followed by @ month of no patching .


The primary outcome was deterioration , defined as constant exotropia measuring at least @ at distance and near or receipt of nonprotocol treatment for IXT .


Of the @ participants ( @ % ) completing the @-month primary outcome examination , deterioration occurred in @ % ( @ of @ ) of the participants in the observation group and in @ % ( @ of @ ) of the participants in the patching group ( difference , @ % ; P = @ ; @ % confidence interval , -@ % to +@ % ) .


Motor deterioration occurred in @ % ( @ of @ ) of the observation group and in @ % ( @ of @ ) of the patching group ( difference , @ % ; P = @ ; @ % confidence interval , -@ % to +@ % ) .


For the observation and patching groups , respectively , @-month mean PACT measurements were @ versus @ at distance ( P = @ ) and @ versus @ at near ( P = @ ) ; @-month mean exotropia control scores were @ versus @ points at distance ( P = @ ) and @ versus @ points at near ( P = @ ) .


Among children @ to @ months of age with previously untreated IXT , deterioration over @ months was uncommon , with or without patching treatment .


There was insufficient evidence to recommend part-time patching for the treatment of IXT in children in this age group .


Despite ultrasound guidance for central line placement , complications persist , as exact needle location is often difficult to confirm with standard two-dimension ultrasound .


A novel real-time needle guidance technology has recently become available ( eZono , Germany ) that tracks the needle during insertion .


This randomized , blinded , crossover study examined whether this needle guidance technology improved cannulation of a simulated internal jugular ( IJ ) vein in an ultrasound phantom .


One hundred physicians were randomized to place a standard needle in an ultrasound neck phantom with or without the needle guidance system .


Video cameras were placed externally and within the lumens of the vessels to record needle location in real time .


The primary outcome measured was the rate of posterior wall puncture .


Secondary outcomes included number of carotid artery punctures , number of needle passes , final needle position , time to cannulation , and comfort level with this new technology .


The incidence of posterior vessel wall puncture without and with needle guidance was @ and @ % , respectively ( P < @ , odds ratio -LSB- OR -RSB- = @ -LSB- @ to @ -RSB- ) .


The rate of carotid artery puncture was higher without needle navigation technology than with needle navigation @ versus @ % , respectively ( P = @ , OR = @ -LSB- @ to @ -RSB- ) .


Final needle tip position being located within the lumen of the IJ was @ % accurate with the navigation technology and @ % accurate with standard ultrasound ( P < @ , OR = @ -LSB- @ to @ -RSB- ) .


Average time for successful vessel cannulation was @ times longer without guidance technology .


This real-time needle guidance technology ( eZono ) shows significant improvement in needle accuracy and cannulation time during simulated IJ vein puncture .


To compare the hemodynamics after combined spinal-epidural anesthesia ( CSEA ) between decubitus and sitting positions in aged patients undergoing total hip replacement .


A total of @ aged patients who underwent CSEA for elective total hip replacement were randomly divided into a decubitus position group ( group D ) and a sitting position group ( group S ; each group with @ patients ) .


In group D , @ mg of @ % bupivacaine were given into the subarachnoid space in decubitus position .


In group S , @ mg of @ % bupivacaine were given into the subarachnoid space in the sitting position , which was maintained for @ min , after which the patients were in decubitus position .


In both groups , the sensory block levels and changes in hemodynamics were assessed .


The mean arterial blood pressure was significantly higher in group S than in group D at each time point within @ min after anesthesia .


There were no significant differences in heart rate between the two groups at each time point .


There was also no significant difference in the level of sensory block between the two groups @ min after the administration of CSEA .


For aged patients undergoing total hip replacement , CSEA is safer and more effective in the sitting position than in decubitus position .


Pathological gambling is associated with elevated proportions of nicotine dependence , and tobacco smoking in pathological gamblers has been associated with increased problem-gambling severity .


This study examined the addition of N-acetylcysteine to imaginal desensitization in adults with co-occurring nicotine dependence and pathological gambling .


Twenty-eight individuals with co-occurring DSM-IV nicotine dependence and pathological gambling who were receiving behavioral therapy were recruited from December @ to February @ and randomized to augmentation with N-acetylcysteine or placebo in an @-week , double-blind trial .


Subjects were assessed with measures of nicotine and gambling severity and followed for @ months after treatment .


The primary outcomes were the Fagerstrm Test for Nicotine Dependence and the pathological gambling adaptation of the Yale-Brown Obsessive-Compulsive Scale .


During the first @ weeks , there was a significant benefit of N-acetylcysteine treatment versus placebo on Fagerstrm Test for Nicotine Dependence total scores ( t = -@ ; P = @ ) .


After the initial @ weeks , all subjects significantly ( P < @ ) benefited from imaginal desensitization .


During the @-month follow-up , there was a significant additional benefit for N-acetylcysteine versus placebo on measures of problem-gambling severity ( t = @ ; P = @ ) .


N-acetylcysteine treatment during therapy facilitates long-term application of behavioral therapy techniques once patients are in the community after therapy has been completed .


To compare the effect of @ vs @ IU of daily oral vitamin D@ on the prevalence of vitamin D deficiency ( VDD ) at @ weeks ' postmenstrual age ( PMA ) in preterm infants of @ to @ weeks ' gestation .


In this randomized double-blind trial , we allocated eligible infants to receive either @ or @ IU of vitamin D@ per day ( n = @ in both groups ) .


Primary outcome was VDD ( serum @-hydroxyvitamin D levels < @ ng/mL ) at @ weeks ' PMA .


Secondary outcomes were VDD , bone mineral content , and bone mineral density at @ months ' corrected age ( CA ) .


Prevalence of VDD in the @-IU group was significantly lower than in the @-IU group at @ weeks ( @ % vs. @ % ; relative risk : @ ; @ % confidence interval : @-@ @ ) and at @ months ' CA ( @ % vs. @ % ; relative risk : @ ; @ % confidence interval : @-@ @ ) .


One infant ( @ % ) in the @-IU group had vitamin D excess ( @-@ ng/mL ) .


Bone mineral content ( mean SD : @ @ vs. @ @ g ; P = @ ) and bone mineral density ( @ @ vs. @ @ g/cm@ ; P = @ ) were not different between the @ groups .


Daily supplementation with @ IU of vitamin D reduces the prevalence of VDD at @ weeks ' PMA and at @ months ' CA in preterm infants without showing any improvement in bone mineralization .


However , there is a possibility that this dose may occasionally result in vitamin D excess .


To explore the effect of early goal-directed therapy ( EGDT ) according to pulse indicated continuous cardiac output ( PiCCO ) on septic shock patients .


Eighty-two septic shock patients in Subei People 's Hospital of Jiangsu Province from January @ to December @ were enrolled and randomly divided into two groups using a random number table , standard surviving sepsis bundle group ( n = @ ) and modified surviving sepsis bundles group ( n = @ ) .


The patients received the standard EGDT bundles in standard surviving sepsis bundle group .


PiCCO catheter was placed in modified surviving sepsis bundles group .


Fluid resuscitation was guided by intrathoracic blood volume index ( ITBVI ) with the aim of @-@ @ mL/m ( @ ) .


Dobutamine was used to improve the heart function according to left ventricular contractile index ( dPmax ) and stroke volume index ( SVI ) .


The mean arterial blood pressure ( MAP ) was maintained @ mmHg ( @ mmHg = @ kPa ) or above with norepinephrine .


Extra-vascular lung water was monitored for the titration of liquid and diuretics .


The acute physiology and chronic health evaluation II ( APACHEII ) score , sequential organ failure assessment ( SOFA ) score , the number of patients needed vasopressor , serum procalcitonin ( PCT ) , lactic acid and lactate extraction ratio , the amount of fluid resuscitation , duration of mechanical ventilation , duration of intensive care unit ( ICU ) stay , hospital mortality were recorded in both groups .


After treatment , the APACHEII score , SOFA score and the number of patients needed vasopressor were gradually reduced in both groups , and those in modified surviving sepsis bundle group were significantly lower than those of standard sepsis bundle group at @ hours ( APACHEII score : @ vs. @ , SOFA score : @ vs. @ , the number of patients needed vasopressor : @ vs. @ , all P < @ ) .


Arterial blood lactate clearance rate was gradually increased after treatment in both groups .


Lactate clearance rate in modified surviving sepsis bundle group was significantly higher than that of standard surviving sepsis bundle group -LSB- @ hours : ( @ ) % vs. ( @ ) % , t = -@ , P = @ ; @ hours : ( @ ) % vs. ( @ ) % , t = -@ , P = @ ; @ hours : ( @ ) % vs. ( @ ) % , t = -@ , P = @ -RSB- .


The amount of fluid resuscitation within @ hours in modified surviving sepsis bundle group increased significantly compared with standard surviving sepsis bundle group ( @ @ mL vs. @ @ mL , t = -@ , P = @ ) .


The amount of fluid resuscitation within @ , @ and @ hours in modified surviving sepsis bundle group was significantly less than that of standard modified surviving sepsis bundle group with the nadir at @ hours ( @ mL vs. @ @ mL , t = @ , P = @ ) .


Duration of mechanical ventilation ( @ hours vs. @ hours , t = @ , P = @ ) and ICU stay ( @ days vs. @ days , t = @ , P = @ ) were significantly reduced in modified surviving sepsis bundle group compared with standard surviving sepsis bundle group .


The hospital mortality in modified surviving sepsis bundle group was slightly lower than that in standard surviving sepsis bundle group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , ( @ ) = @ , P = @ -RSB- .


Modified surviving sepsis bundle treatment according PiCCO can reduce the severity of disease in patients with septic shock , can make more accurately guide fluid resuscitation , and can reduce lung water and duration of mechanical ventilation and ICU stay .


It has great clinical significance .


Identifying the modality and fidelity of simulation that offers the greatest benefit to the learner is critical to Advanced Cardiac Life Support ( ACLS ) training .


Our hypothesis is that participants who receive ACLS training on high-fidelity mannequins will perform better than those trained on low-fidelity mannequins .


The study was performed in the context of an ACLS Initial Provider course for new postgraduate year @ residents and involved @ training arms : ( @ ) low-fidelity , ( @ ) mid-fidelity , and ( @ ) high-fidelity .


Educational outcomes were evaluated by written scores , student evaluations of the course , and expert rater reviews of megacode performance .


A convenience sample of @ subjects was randomized to @ of the @ training arms .


All @ groups significantly improved based on written posttest scores ( P < @ ) ; however , pretest to posttest improvement among the @ training arms was not significantly different : low-fidelity = @ ( @ % CI , @-@ @ ) ; mid-fidelity = @ ( @ % CI , @-@ @ ) ; high-fidelity = @ ( @ % CI , @-@ @ ; P = @ ) .


All participants felt the simulator environment was realistic regardless of level of fidelity .


Participants in the high-fidelity group were less likely to feel comfortable in the simulator environment ( P = @ ) .


Clinical performance as assessed by expert raters ' megacode scores was better for high-fidelity ( @ ) than mid-fidelity ( @ ) ( P = @ ) .


Overall , there was no difference among the @ groups in test scores or perceived instructor or course quality ; however , subjects trained on high-fidelity mannequins performed better than those trained on mid-fidelity with respect to megacode performance .


Acetazolamide is commonly used to treat idiopathic intracranial hypertension ( IIH ) , but there is insufficient information to establish an evidence base for its use .


To determine whether acetazolamide is beneficial in improving vision when added to a low-sodium weight reduction diet in patients with IIH and mild visual loss .


Multicenter , randomized , double-masked , placebo-controlled study of acetazolamide in @ participants with IIH and mild visual loss who received a low-sodium weight-reduction diet .


Participants were enrolled at @ academic and private practice sites in North America from March @ to November @ and followed up for @ months ( last visit in June @ ) .


All participants met the modified Dandy criteria for IIH and had a perimetric mean deviation ( PMD ) between -@ dB and -@ dB .


The mean age was @ years and all but @ participants were women .


Low-sodium weight-reduction diet plus the maximally tolerated dosage of acetazolamide ( up to @ g/d ) or matching placebo for @ months .


The planned primary outcome variable was the change in PMD from baseline to month @ in the most affected eye , as measured by Humphrey Field Analyzer .


Perimetric mean deviation is a measure of global visual field loss ( mean deviation from age-corrected normal values ) , with a range of @ to -@ dB ; larger negative values indicate greater vision loss .


Secondary outcome variables included changes in papilledema grade , quality of life ( Visual Function Questionnaire @ -LSB- VFQ-@ -RSB- and @-Item Short Form Health Survey ) , headache disability , and weight at month @ .


The mean improvement in PMD was greater with acetazolamide ( @ dB , from -@ dB at baseline to -@ dB at month @ ; n = @ ) than with placebo ( @ dB , from -@ dB to -@ dB ; n = @ ) ; the difference was @ dB ( @ % CI , @ to @ dB ; P = @ ) .


Mean improvements in papilledema grade ( acetazolamide : -@ , from @ to @ ; placebo : -@ , from @ to @ ; treatment effect , -@ ; @ % CI , -@ to -@ ; P < @ ) and vision-related quality of life as measured by the National Eye Institute VFQ-@ ( acetazolamide : @ , from @ to @ ; placebo : @ , from @ to @ ; treatment effect , @ ; @ % CI , @ to @ ; P = @ ) and its @-item neuro-ophthalmic supplement ( acetazolamide : @ , from @ to @ ; placebo : @ , from @ to @ ; treatment effect , @ ; @ % CI , @ to @ ; P < @ ) were also observed with acetazolamide .


Participants assigned to acetazolamide also experienced a reduction in weight ( acetazolamide : -@ kg , from @ kg to @ kg ; placebo : -@ kg , from @ kg to @ kg ; treatment effect , -@ kg , @ % CI , -@ to -@ kg ; P < @ ) .


In patients with IIH and mild visual loss , the use of acetazolamide with a low-sodium weight-reduction diet compared with diet alone resulted in modest improvement in visual field function .


The clinical importance of this improvement remains to be determined .


A gel containing diclofenac and hyaluronic acid ( DHA ) and photodynamic therapy with methyl aminolaevulinate ( MAL-PDT ) are widely used treatments for actinic keratoses ( AKs ) .


The aim of this single-centre , open-label , prospective , nonsponsored , randomized controlled clinical trial was to compare the treatment results and cost-effectiveness of MAL-PDT and DHA .


Patients with multiple AKs of the face and scalp were randomized to receive MAL-PDT or DHA .


After @days , the overall complete remission ( CR ) rate of patients and the CR rate of lesions according to thickness score were assessed , and patients and an investigator scored the cosmetic outcome .


In addition , patients scored their overall satisfaction with the treatment .


Patients with CR of all lesions were followed up for @months .


Two hundred patients with a total of @ AKs were enrolled .


The lesion CR rates at @months were @ % with MAL-PDT and @ % with DHA ( P < @ ) .


AKs of all thicknesses were significantly more responsive to MAL-PDT .


The patient CR rates at @months were @ % with MAL-PDT and @ % with DHA .


At the @-month examination , the number of patients with CR reduced to @ with MAL-PDT and seven with DHA .


Rating of cosmetic outcome was very good or excellent in the vast majority of patients with both treatments .


The analysis of cost-effectiveness showed that the costs per patient with CR at @months and at @months are @ and @ , respectively , with MAL-PDT and @ and @ , respectively , with DHA .


Efficacy , cosmetic outcome and patients ' overall satisfaction with MAL-PDT are superior in comparison with DHA .


MAL-PDT is more expensive but it is more cost-effective .


Iron deficiency anaemia ( IDA ) is a common nutritional problem .


To determine the effect of nutritional education and supplemental iron administration on the prevalence of IDA in Arab infants .


Three hundred and ten infants were randomized alternately into two groups .


Mothers ( n = @ ) in the control group received standard information on prevention of IDA and mothers in the intervention group ( n = @ ) received extensive information on the importance of an iron-rich diet .


Data was scored regarding diet contents .


Mothers in the intervention group were encouraged to give their children an iron polymaltose complex ( IPC ) preparation starting from age @ months to @ year .


Compliance of receiving the medication was evaluated .


The groups were compared for outcome by chi-square test .


Main outcome measures were haemoglobin ( Hb ) , mean corpuscular volume ( MCV ) , and serum ferritin levels .


Anaemia ( Hb < @ g/dL ) was recorded in @ % and @ % of the intervention and control groups , respectively ( p = NS ) .


There was no effect of infant or parental background factors on rate of anaemia .


Frequency of anaemia was lower in infants who received @ months of iron medication according to mothers ' reports , and in infants breastfed for @ months ( p = @ ) .


Questions were raised regarding the strategies of preventing IDA in infancy .


Few studies have measured the ability of interventions to affect declining - cell function in screen-detected type @ diabetes .


The Early Diabetes Intervention Programme ( ClinicalTrials.gov NCT@ ) was a randomized study based on the hypothesis that improving postprandial glucose excursions with acarbose would slow the progression of fasting hyperglycaemia in screen-detected type @ diabetes .


In the Early Diabetes Intervention Programme , the effect of acarbose plus lifestyle advice on progression of fasting hyperglycaemia over a @-year period was not greater than that of placebo .


However , there was an early glucose-lowering effect of the trial .


The objective of the current secondary analysis was to describe - cell function changes in response to glucose lowering .


Participants were overweight adult subjects with screen-detected type @ diabetes .


- cell function was measured using hyperglycaemic clamps and oral glucose tolerance testing .


The primary outcome was the change in - cell function from baseline to year @ , the time point where the maximal glucose-lowering effect was seen .


At baseline , participants exhibited markedly impaired first-phase insulin response .


Despite significant reductions in weight , fasting plasma glucose ( PG ) and @-h PG , there was no clinically significant improvement in the first-phase insulin response .


Late-phase insulin responses declined despite beneficial glycaemic effects of interventions .


Insulin secretion is already severely impaired in early , screen-detected type @ diabetes .


Effective glucose-lowering intervention with acarbose was not sufficient to improve insulin secretion or halt the decline of - cell function .


Uncomplicated acute type B aortic dissection ( AD ) treated conservatively has a @ % @-day mortality and up to @ % need intervention within @ years .


In complicated AD , stent grafts have been encouraging .


The aim of the present prospective randomised trial was to compare best medical treatment ( BMT ) with BMT and Gore TAG stent graft in patients with uncomplicated AD .


The primary endpoint was a combination of incomplete/no false lumen thrombosis , aortic dilatation , or aortic rupture at @ year .


The AD history had to be less than @ days , and exclusion criteria were rupture , impending rupture , malperfusion .


Of the @ patients randomised , @ % were DeBakey type IIIB .


Thirty-one patients were randomised to the BMT group and @ to the BMT+TAG group .


Mean age was @ years for both groups .


The left subclavian artery was completely covered in @ % and in part in @ % of the cases .


During the first @ days , no deaths occurred in either group , but there were three crossovers from the BMT to the BMT+TAG group , all due to progression of disease within @ week .


There were two withdrawals from the BMT+TAG group .


At the @-year follow up there had been another two failures in the BMT group : one malperfusion and one aneurysm formation ( p = @ for all ) .


One death occurred in the BMT+TAG group .


For the overall endpoint BMT+TAG was significantly different from BMT only ( p < @ ) .


Incomplete false lumen thrombosis , was found in @ ( @ % ) of the TAG+BMT group and @ ( @ % ) of the BMT group ( p < @ ) .


The false lumen reduced in size in the BMT+TAG group ( p < @ ) whereas in the BMT group it increased .


The true lumen increased in the BMT+TAG ( p < @ ) whereas in the BMT group it remained unchanged .


The overall transverse diameter was the same at the beginning and after @ year in the BMT group ( @ mm ) , but in the BMT+TAG it decreased ( @ mm ; p = @ ) .


Uncomplicated AD can be safely treated with the Gore TAG device .


Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft , but long term results are needed .


Despite the established benefits of exercise for adults with arthritis , participation is low .


Safe , evidence-based , self-directed programs , which have the potential for high reach at a low cost , are needed .


To test a @-week , self-directed , multicomponent exercise program for adults with arthritis .


Randomized controlled trial .


Data were collected from @ to @ .


Data were analyzed in @ and @ .


Adults with arthritis ( N = @ , aged @ -LSB- @ -RSB- years , @ % women , @ % white , @ % African American , BMI of @ -LSB- @ -RSB- ) completed measures at a university research center and participated in a self-directed exercise intervention ( First Step to Active Health ( ) ) or nutrition control program ( Steps to Healthy Eating ) .


Intervention participants received a self-directed multicomponent exercise program and returned self-monitoring logs for @ weeks .


Self-reported physical activity , functional performance measures , and disease-specific outcomes ( arthritis symptoms and self-efficacy ) assessed at baseline , @ weeks , and @ months .


Participants in the exercise condition showed greater increases in physical activity than those in the nutrition control group ( p = @ ) .


Significant improvements , irrespective of condition , were seen in lower body strength , functional exercise capacity , lower body flexibility , pain , fatigue , stiffness , and arthritis management self-efficacy ( p values < @ ) .


More adverse events occurred in the exercise than nutrition control condition , but only one was severe and most were expected with increased physical activity .


The exercise program improves physical activity , and both programs improve functional and psychosocial outcomes .


Potential reasons for improvements in the nutrition control condition are discussed .


These interventions have the potential for large-scale dissemination .


This study is registered at Clinicaltrials.gov NCT@ .


We have recently demonstrated short-term ( @-month ) efficacy and safety of leuprolide acetate @-month depot @ and @ mg in children with central precocious puberty ( CPP ) .


To assess long-term ( @-month ) hypothalamic-pituitary-gonadal axis suppression and safety of leuprolide acetate @-month depot @ and @ mg in children with CPP .


Open-label , @-month extension .


Twenty pediatric endocrine centers .


Seventy-two children ( mean age , @ @ y ; @ females ) with CPP completed and showed maintenance of LH suppression after a @-month lead-in study .


Leuprolide acetate depot ( @ or @ mg ) administered im every @ months .


Peak-stimulated LH , estradiol , T , growth rate , pubertal progression , and adverse events ( AEs ) .


Twenty-nine of @ subjects in the @-mg group and @ of @ subjects in the @-mg group had LH values < @ mIU/mL after day @ at all time points .


All seven subjects who escaped LH suppression at any time still maintained sex steroid concentrations at prepubertal levels and showed no signs of pubertal progression .


AEs were comparable between groups , with injection site pain being the most common ( @ % overall ) .


No AE led to discontinuation of study drug .


The safety profile over @ months was comparable to that observed during the @-month pivotal study .


The two doses of leuprolide acetate @-month depot were associated with an acceptable safety profile and provided maintenance of LH suppression in the majority of children with CPP during the @ months of the study or until readiness for puberty .


Patients with renal insufficiency are hyporesponsive to vaccination , including to hepatitis B vaccines .


A manufacturing process modification for a hepatitis B vaccine ( mpHBV ) was studied in renal pre-dialysis and dialysis patients .


This randomized , open-label , multicenter , estimation study enrolled previously unvaccinated , HBV-seronegative adult dialysis and pre-dialysis patients ( N = @ , median age @ years ) .


At @ , @ , @ , and @ months , group @ received a @ mL intramuscular dose of mpHBV ( containing @ g HBsAg ) as a single injection , while group @ received a @ mL intramuscular dose of a licensed hepatitis B vaccine as two injections ( each containing @ g HBsAg ; @ g HBsAg total ) .


Serum antibody to HBsAg ( anti-HBs ) was measured predose @ , and @ month postdose @ and @ .


Anti-HBs geometric mean concentration ( GMC ) and seroprotection rate ( SPR , % of subjects with anti-HBs titer @ mIU/mL ) were estimated at months @ and @ .


For group @ , month @ SPR was @ % ( @/@ , @ % CI : @ % , @ % ) ; with an additional dose , month @ SPR increased to @ % ( @/@ , @ % CI : @ % , @ % ) .


group @ GMCs at months @ and @ were @ mIU/mL ( @ % CI : @ , @ ) and @ mIU/mL ( @ % CI : @ , @ ) , respectively .


There were @ serious adverse events ; none were considered related to study vaccine .


Both formulations were immunogenic in this population but required more vaccinations to reach seroprotective levels than comparable regimens in healthy individuals , as expected .


The relatively reduced SPRs seen in this population support the need for routine screening and re-dosing in this population .


Inflammation plays a key role in the development of benign prostatic hyperplasia .


Prostaglandin E@ ( PGE@ ) is an important inflammation factor found in enlarged prostatic tissue that can be the main cause of inflammatory pain .


The aim of this study was to investigate whether epidural anesthesia can block the negative effects of prostaglandin mediators during prostate surgery .


The study included @ patients who underwent open prostatectomy .


All patients were randomly allocated to one of two study groups .


The first group received general anesthesia and the second group a combination of general and epidural anesthesia .


Main outcome measures were plasma concentration of PGE@ , adrenaline , noradrenaline , and dopamine , before induction of anesthesia and at the time of enucleation .


Preoperative serum concentrations of PGE@ were high in both groups .


During enucleation , serum concentrations of adrenaline , noradrenaline , and dopamine increased , followed by a rise of systolic and diastolic blood pressure in the group of patients that received only general anesthesia .


Serum concentration of PGE@ was at the same level as before induction of anesthesia in both groups .


Epidural anesthesia blocks transmission of painful stimulus through the spinal cord caused by prostaglandin release and prevents the rise of catecholamines and blood pressure .


Open prostatectomy can become a safer procedure performed under a combination of general and epidural anesthesia .


Negative intraoperative effects of inflammatory prostate mediators during other techniques for prostate surgery could also be blocked with epidural anesthesia .


Population pharmacokinetics ( PK ) of azithromycin ( AZ ) and chloroquine ( CQ ) following administration of fixed-dose combination tablet formulations of AZ and CQ ( AZCQ ) was evaluated using data from two studies : @ ) in children with symptomatic uncomplicated falciparum malaria in sub-Saharan Africa ; and @ ) in healthy adults in the United States .


Study @ included paediatric subjects randomized to either AZCQ or artemether-lumefantrine treatment in Cohort @ ( age @-@years ) and Cohort @ ( age @-@months ) .


Dosing of AZCQ was approximately @mg/kg AZ and @mg/kg CQ once daily for @ days ( for @kg weight : AZ/CQ @/@mg per tablet ; @ to < @kg weight : AZ/CQ @/@mg per tablet ) .


Study @ included adults randomized to receive either two AZCQ tablets ( AZ/CQ @/@mg per tablet ) or individual commercial tablets of AZ @mg and CQ @mg .


Serum AZ and plasma CQ concentrations from both studies were pooled .


Population PK models were constructed using standard approaches to evaluate the concentration-time data for AZ and CQ and to identify any covariates predictive of PK behaviour .


A three-compartment PK model with linear clearance and absorption adequately described AZ data , while a two-compartment model with linear clearance and absorption and an absorption lag adequately described CQ data .


No overall bias or substantial model misspecification was evident using diagnostic plots and visual predictive checks .


Body weight as an allometric function was the only covariate in the final AZ and CQ PK models .


There were significantly lower AZ ( @ vs @ -LSB- mgh/L -RSB- / -LSB- mg/kg -RSB- , p < @ ) and CQ ( @ vs @ -LSB- mgh/L -RSB- / -LSB- mg/kg -RSB- , p < @ ) exposures ( AUCinf ) normalized by dose ( mg/kg ) in children compared with the adults .


The PK of AZ and CQ following administration of AZCQ was well described using a three - and two-compartment model , respectively .


AZ and CQ exhibited linear absorption and clearance ; the model for CQ included an absorption lag .


Weight was predictive of exposure for both AZ and CQ .


Assuming equivalent dosing ( mg/kg ) , AZ and CQ exposure in children would be expected to be lower than that in adults , suggesting that children may require a higher dose ( mg/kg ) than adults to achieve the same AZ and CQ exposure .


In the SAVE-trial we evaluated the safety , reliability and improvements of patient management using the BIOTRONIK Home Monitoring-System ( HM ) in pacemaker ( PM ) and implanted cardioverter defibrillator ( ICD ) patients .


@ PM ( Module A ) and @ ICD-patients ( Module B ) were recruited @ months after implantation .


@ patients in Module A were randomised to HM-OFF and had one scheduled outpatient clinic follow-up ( FU ) per year , whereas patients randomised to HM-ON were equipped with the mobile transmitter and discharged without any further scheduled in-office FU .


In Module B @ patients were randomised to HM-OFF and followed by standard outpatient clinic controls every @ months ; @ patients were randomised to HM-ON receiving remote monitoring plus one outpatient clinic visit per year ; unscheduled follow-ups were performed when necessary .


The average follow-up period was @ @ months in Module A and @ @ months in Module B.


In both modules , the number of FUs per year was significantly reduced ( Module A HM-ON @ @ FUs/year vs HM-OFF @ @ FUs/year ; p b @ ; Module B HM-ON @ @ vs HM-OFF @ @ FU/year , p b @ ) .


Cost analysis was significantly lower in the HM-ON group compared to the HM-OFF group ( @ @ and @ @ respectively ; p b @ ) .


@ % of the unscheduled visits in Module B were clinically indicated , whereas @ % of the routine FUs were classified as clinically unnecessary .


Remote home monitoring of pacemaker and ICD devices was safe , reduced overall hospital visits , and detected events that mandated unscheduled visits .


This study is designed to address the need for evidence-based HIV/STI prevention approaches for drug-involved women under criminal justice community supervision .


We tested the efficacy of a group-based traditional and multimedia HIV/STI prevention intervention ( Project WORTH : Women on the Road to Health ) among drug-involved women under community supervision .


We randomized @ women recruited from community supervision settings to receive either : ( @ ) a four-session traditional group-based HIV/STI prevention intervention ( traditional WORTH ) ; ( @ ) a four-session multimedia group-based HIV/STI prevention intervention that covered the same content as traditional WORTH but was delivered in a computerized format ; or ( @ ) a four-session group-based Wellness Promotion intervention that served as an attention control condition .


The study examined whether the traditional or multimedia WORTH intervention was more efficacious in reducing risks when compared to Wellness Promotion ; and whether multimedia WORTH was more efficacious in reducing risks when compared to traditional WORTH .


Primary outcomes were assessed over the @-month post-intervention period and included the number of unprotected sex acts , the proportion of protected sex acts , and consistent condom use .


At baseline , @ % of participants reported unprotected vaginal or anal sex ( n = @ ) and @ % ( n = @ ) had multiple sex partners .


Women assigned to traditional or multimedia WORTH were significantly more likely than women assigned to the control condition to report an increase in the proportion of protected sex acts ( = @ ; @ % CI = @-@ @ ) and a decrease in the number of unprotected sex acts ( IRR = @ ; @ % CI = @-@ @ ) .


The promising effects of traditional and multimedia WORTH on increasing condom use and high participation rates suggest that WORTH may be scaled up to redress the concentrated epidemics of HIV/STIs among drug-involved women in the criminal justice system .


Ligand-mediated activation of the androgen receptor ( AR ) is critical for prostate cancer ( PCa ) survival and proliferation .


The failure to completely ablate tissue androgens may limit suppression of PCa growth .


We evaluated combinations of CYP@A and @ -- reductase inhibitors for reducing prostate androgen levels , AR signaling , and PCa volumes .


Thirty-five men with intermediate/high-risk clinically localized PCa were randomly assigned to goserelin combined with dutasteride ( ZD ) , bicalutamide and dutasteride ( ZBD ) , or bicalutamide , dutasteride , and ketoconazole ( ZBDK ) for @ months before prostatectomy .


Controls included patients receiving combined androgen blockade with luteinizing hormone-releasing hormone agonist and bicalutamide .


The primary outcome measure was tissue dihydrotestosterone ( DHT ) concentration .


Prostate DHT levels were substantially lower in all experimental arms ( @ to @ ng/g v @ ng/g in controls ; P < @ ) .


The ZBDK group demonstrated the greatest percentage decline in serum testosterone , androsterone , and dehydroepiandrosterone sulfate ( P < @ for all ) .


Staining for AR and the androgen-regulated genes prostate-specific antigen and TMPRSS@ was strongly suppressed in benign glands and moderately in malignant glands ( P < @ for all ) .


Two patients had pathologic complete response , and nine had @ cm ( @ ) of residual tumor ( defined as a near-complete response ) , with the largest numbers of complete and near-complete responses in the ZBDK group .


Addition of androgen synthesis inhibitors lowers prostate androgens below that achieved with standard therapy , but significant AR signaling remains .


Tissue-based analysis of steroids and AR signaling is critical to informing the search for optimal local and systemic control of high-risk prostate cancer .


This prospective registry assessed the safety and efficacy of paclitaxel coated balloon ( PCB ) angioplasty for small vessel coronary artery disease in Europe and Asia with the intention to treat lesions without additional stenting .


The use of PCBs in small vessels seems to be associated with favourable outcomes ; however , prospective data for the use of PCBs without stenting are limited .


The SeQuent Please Small Vessel ` PCB only ' Registry was an international , prospective , multicentre registry enrolling patients with de novo lesions of small reference diameters ( @ mm , @ mm ) .


The primary end point was clinically driven target lesion revascularisation ( TLR ) at @ months .


Secondary end points were acute technical success , in-hospital outcomes , @-month major adverse cardiac events ( MACE ) ( death , myocardial infarction , or TLR ) , and the occurrence of definite lesion and vessel thrombosis .


A total of @ patients ( @ @ years , @ % diabetics ) were enrolled , @ ( @ % ) with an acute coronary syndrome , @ ( @ % ) with ST elevation myocardial infarction ( STEMI ) , and @ ( @ % ) with non-STEMI .


The initial procedural success rate was @ % ; @ patients ( @ % ) needed additional bare metal stent implantation .


TLR at @ months occurred in @ patients ( @ % ) , while three patients ( @ % ) had vessel thrombosis in non-target lesions .


There was no cardiac death or coronary artery bypass graft surgery .


To date , this is the largest prospective study with PCBs in small vessel de novo lesions in unselected patients .


Rates of TLR and MACE were low , suggesting the use of PCBs may be an attractive alternative treatment option to drug eluting stents in small vessels .


This study aimed to determine the safety and efficacy of intraoperative intensive glycaemic treatment with modified glucose-insulin-potassium solution by hyperinsulinemic normoglycaemic clamp in cardiopulmonary bypass surgery patients .


We hypothesised that the treatment would reduce infection rates in this group of patients .


A prospective , randomised , double-blind trial was conducted in cardiopulmonary bypass surgery patients .


A total of @ adult patients ( out of a planned @ ) were randomly allocated to intensive or conventional treatment with target glucose levels of @-@ @ mmol/l and < @ mmol/l , respectively .


The primary outcomes were clinical infection and cytokine levels , including interleukin ( IL ) -@ and IL-@ .


The secondary outcomes were morbidity and mortality .


The study was terminated early because of safety concerns ( hypoglycaemia ) .


The clinical post-operative infection rate was @ % in the intensive group and @ % in the conventional group ( P = @ ) .


The proportion of patients with hypoglycaemia was significantly higher in the intensive group ( @ % ) compared with the conventional group ( @ % ) ( P < @ ) .


Morbidity and mortality rates were similar for both groups .


Anaesthetic duration > @ h ( vs. @ h ) , pre-operative IL-@ level > @ pg/ml ( vs. @ pg/ml ) and post-operative IL-@ level @-@ pg/ml ( vs. @ pg/ml ) were independent predictors for post-operative infection .


Intraoperative intensive glycaemic treatment significantly increased the risk of hypoglycaemia , but its effect on post-operative infection by clinical assessment could not be determined .


Anaesthetic duration , pre-operative and post-operative IL-@ levels can independently predict post-operative infection .


Preclinical and clinical trials suggest that yohimbine may augment extinction learning without significant side effects .


However , previous clinical trials have only examined adults with specific phobias .


Yohimbine has not yet been investigated in the augmentation of exposure therapy for other anxiety disorders .


Adults ( n = @ ) with a DSM-IV diagnosis of social anxiety disorder were randomized to placebo or yohimbine HCl ( @ mg ) @ hour before each of four exposure sessions .


Outcome measures were collected at baseline , each treatment session , posttreatment , and @-month follow-up .


Yohimbine was well tolerated .


Yohimbine augmentation , relative to placebo augmentation , resulted in faster improvement and better outcomes on self-report measures of social anxiety disorder severity ( Liebowitz Social Anxiety Scale , d = @ ) and depressed mood severity ( Beck Depression Inventory , d = @ ) but not on the clinician-rated measures ( Clinical Global Impressions-Severity Scale , d = @ ; Clinical Global Impressions-Improvement Scale , d = @ ) .


Between-group differences on the Liebowitz Social Anxiety Scale were moderated by the level of fear reported at the end of an exposure exercise ( end fear ) , such that the advantage of yohimbine over placebo was only evident among patients who reported low end fear .


The results provide moderate support for yohimbine as a therapeutic augmentation strategy for exposure therapy in social anxiety disorder , one that may be especially effective when coupled with successful exposure experiences .


Beneficial effects for yohimbine were readily evident for self-report measures but not for clinician-rated outcomes of social anxiety severity and improvement .


The aim of this study was to evaluate the effect of long-term administration of liquid nutritional supplement with increased amounts of whey protein and reduced amounts of lactose , produced in accordance with a new recipe `` Nutrisen '' on the elderly living in institutionalized care .


The study was carried out from May to July , @ , on @ retirement home residents , living in Prague , all of which were @ years or older .


Supplemented group ( n = @ ) consumed ( @ ml ) milk drinks with three different flavours on a daily basis for eight weeks .


The reference group was on a normal diet .


There was no significant difference in baseline characteristics between participants in both groups .


Anthropometric and biochemical indicators of nutritional status and tolerance of the nutritional supplement during long-term use were evaluated .


Both compliance ( daily intake program ) and tolerance of the nutritionally defined supplement were very good .


For the supplemented group , there was an average weight increased of @ grams after the @ week nutritional supplement test period .


Average levels of albumin and prealbumin increased significantly ( from the beginning to the end of the program ) , @ @ g/l vs @ @ g/l and @ @ vs @ @ g/l ( p < @ ) , vitamin D levels increased from @ @ nmol/l to @ @ nmol/l ( p < @ ) and HDL-cholesterol levels increased from @ @ mmol/l to @ @ mmol/l ( p < @ ) .


The specific nutritionally defined milk drink ( Nutrisen ) , used in this study , was well tolerated by the elderly study participants , over the eight-week clinical study .


We observed a positive effect on the participants weight , serum albumin , prealbumin , vitamin D and HDL-cholesterol .


Insight into delusional beliefs varies in patients with major depressive disorder ( MDD ) with psychotic features ( `` psychotic depression '' ) .


The relationship between impaired insight and illness severity and its impact on treatment outcomes has not been studied in psychotic depression .


As such , the aim of this analysis was to explore the relationship among impaired insight , patient characteristics ( ie , illness severity , cognition , suicidality , and social functioning ) , and treatment outcome ( ie , remission ) during acute treatment of psychotic depression .


This secondary analysis is based on the data from the Study of Pharmacotherapy for Psychotic Depression ( STOP-PD ) in which @ participants meeting DSM-IV criteria for MDD with psychotic features enrolled between December @ and June @ ( including @ aged @ years ) in a @-center , @ - week , double-blind , randomized controlled trial funded by the US National Institutes of Health .


Insight into delusions was assessed using the Delusion Assessment Scale ( DAS ) .


The primary outcomes were the predictive utility of insight into illness ( ie , Hamilton Depression Rating Scale -LSB- HDRS -RSB- insight item ) and insight into delusions ( conviction factor derived from the DAS ) on final treatment outcome at @ weeks of treatment ( ie , full remission , partial remission , and nonremission ) .


At baseline , impaired insight into delusions was positively associated with illness severity ( HDRS-@ which excluded the insight item , r = @ , P = @ ) and negatively correlated with measures of cognition ( P < @ ) .


Improvement in insight was not associated with changes in cognition , suicidality , or social functioning after adjusting for covariates .


Independent of the severity of depression or psychosis , impaired insight into delusions at baseline ( = @ , P = @ ) and after @ ( = @ , P = @ ) , @ ( = @ , P = @ ) , and @ ( = @ , P = @ ) weeks of treatment predicted remission at the end of the trial .


Impaired insight into delusions appears to be an independent predictor of remission in MDD with psychotic features during acute treatment , suggesting that more attention should be paid to this symptom .


Longitudinal studies are required to determine the impact of impaired insight into delusions on long-term outcomes , including relapse .


Therapy-induced mucositis and dysphagia puts head and neck ( H&N ) cancer patients at increased risk for developing cachexia .


Omega-@ fatty acids ( n-@ FA ) have been suggested to protect against cachexia .


We aimed to examine if echium oil , a plant source of n-@ FA , could reduce weight loss in H&N cancer patients undergoing radio ( chemo ) therapy with curative intent .


In a double-blind trial , patients were randomly assigned to echium oil ( intervention ( I ) group ; @ ml bis in die ( b.i.d. ) , @ mg/ml - linolenic acid ( ALA ) + @ mg/ml stearidonic acid ( SDA ) + @ mg/ml - linolenic acid ( GLA ) ) or n-@ FA deficient sunflower oil high oleic ( control ( C ) group ; @ ml b.i.d. ) additional to standard nutritional support during treatment .


Differences in percentage weight loss between both groups were analysed according to the intention-to-treat principle .


Erythrocyte FA profile , body composition , nutritional status and quality of life were collected .


Ninety-one eligible patients were randomised , of whom @ were evaluable .


Dietary supplement adherence was comparable in both groups ( median , I : @ % , C : @ % ) .


At week @ , the I group showed significantly increased values of erythrocyte n-@ eicosapentanoic acid ( EPA , @ % vs -@ % ) and n-@ GLA ( @ % vs -@ % ) compared to the C group , without a significant change in n-@ arachidonic acid ( AA , @ % vs -@ % ) .


Intention-to-treat analysis could not reveal a significant reduction in weight loss related to echium oil consumption ( median weight loss , I : @ % , C : @ % ) .


Also , no significant improvement was observed in the other evaluated anthropometric parameters .


Echium oil effectively increased erythrocyte EPA and GLA FAs in H&N cancer patients .


It failed however to protect against weight loss , or improve nutritional parameters .


To evaluate the expression of matrix metalloproteinase @ ( MMP@ ) and transglutaminase @ ( TG@ ) in different forms of dry eye .


Case control study .


Seventy-five female subjects divided into @ groups : group @ , @ healthy controls ; group @ , @ subjects with Sjgren syndrome ( SS ) ; and group @ , @ subjects with Meibomian gland dysfunction ( MGD ) .


A clinical assessment was carried out and impression cytologic specimens were processed for immunoperoxidase staining for MMP@ and TG@ and real-time polymerase chain reaction analyses were carried out for MMP@ , TG@ , interleukin-@ , interferon - , B-cell lymphoma @ , and caspase @ .


To study MMP@ and TG@ expression after anti-inflammatory treatment , patients were divided into @ subgroups , one treated with saline and the other treated with saline plus topical corticosteroid eye drops ( @ % loteprednol etabonate ) @ times daily for @ days .


For statistical analysis , Student t test , Mann-Whitney U test , and Spearman 's correlation coefficient were used as appropriate .


Conjunctival expression of MMP@ and TG@ .


MMP@ and TG@ expression were higher in both patient groups than in controls ( P < @ ) .


Group @ patients showed higher expression than group @ ( P < @ ) .


The Spearman 's correlation coefficient showed in group @ a positive correlation between MMP@ and TG@ expression ( = @ ; P = @ ) , but no correlation in group @ ( = @ ; P = @ ) .


Corticosteroid treatment significantly reduced MMP@ and TG@ expression in both groups , ameliorating symptoms and signs .


A much higher percentage reduction was observed in SS .


The pathogenic mechanisms of the @ forms of dry eye give an account for the different MMP@ and TG@ expressions in the @ groups of patients .


The higher expression in SS is determined by the direct autoimmune insult to the ocular surface epithelia , whereas in MGD patients , with an epithelial damage due to an unbalanced tear secretion , the molecules expression is significantly lower , although higher than in controls .


The corticosteroid treatment induced a reduction of both molecules , although higher in SS than in MGD , because of its direct inhibitory effect on inflammation .


Few studies have examined the differential effects of weight management by exercise mode on subclinical atherosclerosis .


We hypothesized that @ modes of aerobic , resistance , and combination exercises have differential effects on the flow-mediated dilation ( FMD ) , carotid-femoral pulse wave velocity ( PWV ) , and carotid intima-media thickness ( IMT ) as well as cardiometabolic profile in weight management .


A randomized , single-blind trial ( ISRCTN@ ) was conducted in Seoul , South Korea between November @ and December @ .


Randomized participants were @ women with abdominal obesity ( aerobic group n = @ ; resistance group n = @ ; combination exercise group n = @ ) .


The treatment period was @ months with @-month follow up : A diet-alone intervention for the first @ months and a diet-plus-exercise intervention for the next @ months according to exercise modes .


The exercise training was designed with an intensity of @-@ % heart rate reserve for @ days a week in @-minute-long sessions for @ months , consisting of @-minute treadmill and @-minute bike exercises for aerobic group ; upper and lower body exercises with an intensity target of @ sets and @-@ repetitions for resistance group ; @-minute resistance and consecutive @-minute aerobic exercises for combination group .


Ninety-two and @ participants were analyzed for modified intention-to-treat analysis and per-protocol ( PP ) analysis , respectively .


The @ exercise modes had no significant differential effects on FMD , PWV , and IMT over time ; however , the combination group was found to have significantly lower levels of fasting glucose than the aerobic group ( p = @ ) in the PP analysis .


Nevertheless , we observed significant time effects such as reductions in PWV ( p = @ ) and IMT ( p = @ ) in cubic and quadratic trends , respectively , and improvements in body weight , waist circumference , low-density and high-density lipoprotein cholesterol levels , fasting glucose levels , and cardiorespiratory fitness in linear , quadratic , or cubic trends .


For women with abdominal obesity , a combination of aerobic and resistance exercises may be preferable to a single exercise mode for effective glucose control .


Regardless of exercise mode , exercise interventions combined with dietary interventions in weight management may be beneficial in reducing the risk of subclinical atherosclerosis and cardiometabolic risk .


We recently completed a randomized controlled trial of an endoscopic quality improvement program ( EQUIP ) that demonstrated an improved adenoma detection rate ( ADR ) through simple educational interventions .


The aim of this study ( phase III ) is to examine whether the improvement in ADR in the trained endoscopists remained stable with further follow-up .


We prospectively followed up @ staff endoscopists who had previously been randomized to a quality improvement intervention .


In the current study , we examined an additional @,@ colonoscopy procedures conducted over a @-month time period following the original study , referred to as phase III .


During this time , all physicians received quarterly ADR and other quality metric feedback , and the previous control group was offered the educational intervention voluntarily .


ADRs and adenoma per patient ( APP ) rates were estimated in the endoscopists who were and were not randomized to EQUIP training and compared with those obtained in phases I and II of the original study .


The study was conducted in a tertiary care Academic Medical Center .


The study sample comprised @ patients undergoing routine colonoscopy .


The main outcome measurement was adenoma detection rate .


The previously observed increase in ADR in the trained group from @ % in phase I to @ % in phase II was maintained into phase III ( @ % ) .


The ADR of the untrained group remained unchanged from phase I ( @ % ) to phase II ( @ % ) ; it was increased only marginally in phase III to @ % , which was still lower than the @ % ADR in the trained group .


The trained group had an increase in APP , from @ in Phase I to @ in Phase II and @ in Phase III .


For the previously untrained group , there was no change in APP from phase I ( @ ) to phase II ( @ ) , but there was possibly a small increase ( to @ ) in Phase III .


This study provides evidence that improvements in ADR obtained through the endoscopic quality-training program can persist for at least @ months after completion of the program .


It further suggests that a focus on ADR does not lead to a `` one and done '' phenomenon .


The limitations of this study were as follows : single-center setting , and lack of sessile polyp information/standardization .


To evaluate the condition of cancer-related fatigue ( CRF ) in breast cancer patients with chemotherapy and to explore the effect of Yoga on it .


After the completion of Yoga , @ breast cancer patients with CRF ( CFS > @ ) were selected and were randomly divided into the Yoga group and the control group ( n = @ ) .


Patients in the control group only received routine cure and care while patients in the Yoga group received extra Yoga exercise , lasting for @ months .


Cancer fatigue scale ( CFS ) was evaluated in the @nd , @th and @th round of chemotherapy .


At the end , @ cases qualified for the study , @ cases for the control group and @ for the Yoga group .


The mean score of body fatigue was @ .


There was no significant difference in CRF between the Yago group and the control group before the Yoga intervention ( P > @ ) .


After the @th round of chemotherapy , the mean scores of CFS and body fatigue in the Yoga group were significantly lower than that in the control group ( P < @ ) .


After the @th round of chemotherapy , the mean scores of CFS , body fatigue and cognitive fatigue in the Yoga group were lower than that in the control group ( P < @ ) .


Repeated analysis of variance showed that the difference in the overall fatigue , body fatigue and cognitive fatigue between the Yoga group and the control group was significant ( P < @ ) ; the time influence on the overall fatigue , body fatigue and emotional fatigue was significant difference between the @ groups ( P < @ ) ; there were interactions between the effect of Yago and time on the overall fatigue , body fatigue and cognitive fatigue ( P < @ ) .


The body fatigue was more serious in breast cancer patients with chemotherapy .


Yoga intervention could significantly reduce body fatigue , cognitive fatigue , thus reduce the overall fatigue in breast cancer patients with chemotherapy .


To assess the efficacy and safety of LY@ , a selective estrogen receptor beta agonist , on lower urinary tract symptoms ( LUTS ) in patients with enlarged prostate secondary to BPH .


In a randomized , double-blind , placebo-controlled , parallel phase @ , efficacy and safety study , eligible patients with moderate to severe LUTS and prostatic enlargement ( @ml ) were randomized to placebo or LY@ at @ , @ , @ and @mg once daily for @ weeks .


Primary efficacy end point was change in total International Prostate Symptoms Score ( IPSS ) after @ weeks .


Secondary end points included changes in total prostate volume ( TPV ) that served as a proof of concept end point , as well as IPSS quality of life , maximum peak urine flow rate ( Qmax ) and PSA and safety ( adverse events , laboratory test ) .


A total of @ patients were randomized when the study was terminated because of insufficient TPV reduction , based on a priori defined interim analysis .


The IPSS mean change from baseline to end point was -@ in the placebo group and -@ , -@ , -@ and -@ in the @ , @ , @ and @mg LY@-treated groups , respectively ( P > @ ) .


Similarly , no treatment effect was observed for any of the secondary efficacy measures .


Incidence of adverse events was comparable between treatment groups , and no clinically meaningful changes in laboratory tests were observed .


LY@ was well tolerated in BPH patients with LUTS at doses up to @mg once daily for @ weeks .


The study was terminated early because of inadequate efficacy .


Phosphodiesterase-@ ( PDE@ ) inhibitors improve exercise capacity and quality of life in patients with idiopathic pulmonary arterial hypertension .


However , whether such beneficial effects take place in selected populations with chronic obstructive pulmonary disease ( COPD ) remains uncertain .


We aimed to assess the effects of tadalafil -- a PDE@ inhibitor -- on exercise capacity and quality of life in patients with COPD and mild pulmonary hypertension .


We did a randomised , double-blind , parallel-group , placebo-controlled trial at three centres in Scotland , UK , between Sept @ , @ , and Sept @ , @ .


Patients with moderate to severe COPD were randomly assigned ( @:@ ) , via centralised randomisation with a computer-generated sequence and block sizes of four , to receive daily tadalafil @ mg or placebo for @ weeks .


Patients , study investigators , outcome assessors , and those administering drugs were masked to group allocation .


The primary endpoint was the mean placebo-corrected difference between the baseline and final @ min walk distance after @ weeks .


We measured change in quality of life at baseline , @ weeks , and @ weeks , with standardised questionnaires .


Analysis was per protocol and by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT@ .


@ patients were randomly assigned to receive tadalafil ( n = @ ) or placebo ( n = @ ) , of whom @ ( @ % ) versus @ ( @ % ) completed the study .


At @ weeks the difference in @ min walking distance between the tadalafil and placebo groups was @ m ( @ % CI -@ to @ ; p = @ ) .


We recorded no statistically significant changes in quality of life ( between-group difference on the St George 's Respiratory Questionnaire -@ -LSB- @ % CI -@ to @ -RSB- ; Research and Development version @ short-form-@ @ -LSB- -@ to @ -RSB- ; Minnesota Living with Heart Failure questionnaire -@ -LSB- -@ to @ -RSB- ) .


@ ( @ % ) of @ patients in the treatment group had dyspepsia ; the severity of dyspepsia ranged from mild to severe , with four ( @ % ) of @ patients needing a proton-pump inhibitor .