Coprimary efficacy endpoints were the proportions of treatment responders , defined as a @-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale ( CR-SMFRS ) , and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale ( SSRS score @ ) .


Secondary efficacy endpoints included a @-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale ( PR-SMFRS ) and changes in the Patient-Reported Submental Fat Impact Scale ( PR-SMFIS ) .


Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded .


Adverse events ( AEs ) and laboratory test results were monitored .


Compared with placebo , a greater proportion of patients treated with ATX-@ @ and @ mg/cm ( @ ) showed a @-point improvement in CR-SMFRS ( @ % and @ % , respectively , vs. @ % with placebo ; P < @ ) and patient satisfaction ( SSRS score @ ) with the appearance of their face and chin ( @ % and @ % , respectively , vs. @ % ; P < @ ) .


Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity ( PR-SMFRS ; P = @ for ATX-@ @ mg/cm ( @ ) , P < @ for ATX-@ @ mg/cm ( @ ) vs. placebo ) and emotions and perceived self-image ( PR-SMFIS ; P < @ ) .


No overall worsening of skin laxity was observed .


AEs were mostly transient , mild to moderate in intensity and localized to the treatment area .


ATX-@ was effective and well tolerated , and may be an alternative to surgery for patients desiring improvement of their submental profile .


Transnasal endoscopy ( TNE ) with ultrathin endoscopes has been advocated as an attractive alternative , for diagnostic upper endoscopy .


To assess tolerability , acceptability and quality of TNE , in comparison with standard upper endoscopy ( SOGD , standard oesophago-gastro-duodenoscopy ) under local anaesthetic .


We prospectively recruited @ patients ( @ females/@ males ) mean age @years .


The Fujinon EG@N ( @ mm ) and EG@WR ( @ mm ) endoscopes were used .


The endoscopist and all patients completed detailed questionnaires regarding tolerability , acceptance and quality of endoscopy using standard visual analogue scales ( VAS ) .


Oxygen saturation ( SaO@ ) , heart rate ( HR ) and systolic blood pressure ( SBP ) were recorded .


Quality of biopsies was evaluated .


Analysis included @ procedures ( TNE :@ , SOGD :@ ) with duodenal intubation achieved in all patients .


VAS scores for patient comfort were significantly better in the TNE group ( @ vs. @ respectively , P < @ ) .


Twenty patients with previous experience of standard endoscopy were randomised to TNE and @ of them ( @ % ) preferred the TNE .


Gagging was significantly less in the TNE group ( @ vs. @ respectively , P < @ ) .


Cardiovascular stress was significantly less in the TNE group irrespective of the degree of gagging or comfort .


TNE biopsies were smaller , but adequate for definitive diagnosis , similarly to standard endoscopy .


Transnasal endoscopy is superior to SOGD in terms of comfort and patient acceptance with significantly less cardiovascular stress .


TNE can routinely be used as alternative to SOGD under local anaesthetic , for diagnosis and should be preferentially offered in cardiorespiratory compromised patients .


To determine whether glutamate-evoked jaw muscle pain is altered by the temperature of the solution injected .


Sixteen healthy volunteers participated and received injections of hot ( @C ) , neutral ( @C ) , or cold ( @C ) solutions ( @ mL ) of glutamate or isotonic saline into the masseter muscle .


Pain intensity was assessed with an electronic visual analog scale ( eVAS ) .


Numeric rating scale ( NRS ) scores of unpleasantness and temperature perception , pain-drawing areas , and pressure pain thresholds ( PPTs ) were also measured .


Participants filled out the McGill Pain Questionnaire ( MPQ ) .


Two-way or three-way repeated measures ANOVA were used for data analyses .


Injection of hot glutamate and cold glutamate solutions significantly increased and decreased , respectively , the peak pain intensity compared with injection of neutral glutamate solution .


The duration of glutamate-evoked pain was significantly longer when hot glutamate was injected than when cold glutamate was injected .


No significant effect of temperature on pain intensity was observed when isotonic saline was injected .


No effect of solution temperature was detected on unpleasantness , heat perception , cold perception , area of pain drawings , or PPTs .


There was a significantly greater use of the `` numb '' term in the MPQ to describe the injection of cold solutions compared to the injection of both neutral and hot solutions .


Glutamate-evoked jaw muscle pain was significantly altered by the temperature of the injection solution .


Although temperature perception in the jaw muscle is poor , pain intensity is increased when the muscle tissue temperature is elevated .


Vascular dysfunction plays a central role in sepsis , and it is characterized by hypotension and hyporesponsiveness to vasoconstrictors .


Nitric oxide is regarded as a central element of sepsis vascular dysfunction .


The high amounts of nitric oxide produced during sepsis are mainly derived from the inducible isoform of nitric oxide synthase @ .


We have previously shown that nitric oxide synthase @ levels decrease in later stages of sepsis , whereas levels and activity of soluble guanylate cyclase increase .


Therefore , we studied the putative role of other relevant nitric oxide sources , namely , the neuronal ( nitric oxide synthase @ ) isoform , in sepsis and its relationship with soluble guanylate cyclase .


We also studied the consequences of nitric oxide synthase @ blockade in the hyporesponsiveness to vasoconstrictors .


Randomized controlled prospective experimental study .


Academic research laboratory .


Female Wistar rats submitted to cecal ligation and puncture method .


@ ) Six , @ , and @ hours after cecal ligation and puncture , vascular reactivity to phenylephrine ( @ and @ nmol/kg ) before and after @-nitroindazole ( @ mol/kg , s.c. ) or aminoguanidine ( @ mol/kg , s.c. ) administration was evaluated .


@ ) Protein levels and interaction between nitric oxide synthase @ and soluble guanylate cyclase were determined .


@ ) Six , @ , and @ hours after cecal ligation and puncture , thoracic aorta segments were stimulated with phenylephrine in the presence or absence of @-nitroindazole and cyclic guanosine monophosphate accumulation was determined .


@ ) After @ hours of cecal ligation and puncture , norepinephrine was infused ( @ g/kg/min ) in the presence or absence of @-nitroindazole or S-methyl-L-thiocitrulline ( @ mol/kg , IV ) and mean arterial pressure was registered .


@ ) Both nitric oxide synthase @ and soluble guanylate cyclase are expressed in higher levels in vascular tissues during sepsis ; @ ) both proteins physically interact and nitric oxide synthase @ blockade inhibits cyclic guanosine monophosphate production ; @ ) pharmacological blockade of nitric oxide synthase @ using @-nitroindazole or S-methyl-L-thiocitrulline reverts the hyporesponsiveness to phenylephrine and increases the vasoconstrictor effect of norepinephrine and phenylephrine .


Sepsis induces increased expression and physical association of nitric oxide synthase @/soluble guanylate cyclase and a higher production of cyclic guanosine monophosphate that together may help explain sepsis-induced vascular dysfunction .


In addition , selective inhibition of nitric oxide synthase @ restores the responsiveness to vasoconstrictors .


Therefore , inhibition of nitric oxide synthase @ ( and possibly soluble guanylate cyclase ) may represent a valuable alternative to restore the effectiveness of vasopressor agents during late sepsis .


Retrospective cohort study .


To identify risk factors for poor short-term outcomes after vertebral augmentation procedures .


Vertebral compression fractures are the most common fractures of osteoporosis and are frequently treated with vertebroplasty or kyphoplasty .


There is a shortage of information about risk factors for short-term , general health outcomes after vertebral augmentation in the literature .


Patients older than @ years who underwent vertebroplasty or kyphoplasty in @ and @ were identified from the American College of Surgeons National Surgical Quality Improvement Program database .


Patient characteristics were tested for association with @-day adverse events , mortality , and readmission using bivariate and multivariate analyses .


A total of @ patients met inclusion criteria .


The average age was @ years ( meanstandard deviation ) and females made up @ % of the cohort .


Of these patients , @ % had any adverse event ( AAE ) , and @ % had a serious adverse event ( SAE ) .


Death occurred in @ % of patients , and @ % were readmitted within the first @ postoperative days.On multivariate analysis , AAE and SAE were both significantly associated with American Society of Anesthesiologists class @ ( AAE : odds ratio -LSB- OR -RSB- = @ , P = @ ; SAE : OR = @ , P = @ ) and inpatient status before procedure ( AAE : OR = @ , P < @ , SAE : OR = @ , P = @ ) .


Increased postoperative mortality rate was associated with American Society of Anesthesiologists class @ ( OR = @ , P = @ ) and the use of nongeneral anesthesia ( OR = @ , P = @ ) .


Readmission was associated with history of pulmonary disease ( OR = @ , P = @ ) and inpatient status before procedure ( OR = @ , P = @ ) .


Adverse general health outcomes were relatively common , and the factors identified in the earlier text associated with patient outcomes after vertebral augmentation may be useful for preoperative discussions and counseling .


To study the association between changes in brain magnetic resonance imaging ( MRI ) and clinical outcomes in early MS.


MS patients within @ months of onset were enrolled and followed up to @ years .


Clinical measures included Symbol Digit Modalities Test ( SDMT ) , MS Functional Composite ( MSFC ) and low contrast letter acuity ( LCLA ) .


MRI outcomes included brain volume changes measured by SIENA and SIENAX normalized measurements -LSB- brain parenchymal volume ( BPV ) , normal-appearing white and gray matter volume ( NAWMV and GMV ) and T@ lesion volume ( T@LV ) -RSB- .


Mixed model regression measured time trends and associations between imaging and clinical outcome .


Forty-three patients were enrolled within @ months of onset .


Baseline T@ lesion volume predicted subsequent changes in Paced Auditory Serial Addition Test ( PASAT ) ( p = @ ) , whereas baseline measures of atrophy including BPV , GMV , and NAWMV predicted longitudinal changes in MSFC ( p = @ , p = @ , p = @ , respectively ) and Timed-@ Foot Walk ( p < @ ) .


Each @ % decrease in SIENA was associated with @ point decrease in SDMT score ( p = @ ) .


Each @ % decrease in brain volume SIENA was associated with almost @ letters decrease on LCLA ( p = @ ) .


Measures of lesion volume and overall brain volume were associated with different long-term clinical outcome measures in early MS.


VEGFR-@ has a role in gastric cancer pathogenesis and progression .


We assessed whether ramucirumab , a monoclonal antibody VEGFR-@ antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel .


This randomised , placebo-controlled , double-blind , phase @ trial was done at @ centres in @ countries in North and South America , Europe , Asia , and Australia .


Patients aged @ years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within @ months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were randomly assigned with a centralised interactive voice or web-response system in a @:@ ratio to receive ramucirumab @ mg/kg or placebo intravenously on days @ and @ , plus paclitaxel @ mg/m ( @ ) intravenously on days @ , @ , and @ of a @-day cycle .


A permuted block randomisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used .


The primary endpoint was overall survival .


Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug .


This trial is registered with ClinicalTrials.gov , number NCT@ , and has been completed ; patients who are still receiving treatment are in the extension phase .


Between Dec @ , @ , and Sept @ , @ , @ patients were randomly assigned to treatment-@ to ramucirumab plus paclitaxel and @ to placebo plus paclitaxel .


Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @ % CI @-@ -RSB- , hazard ratio @ -LSB- @ % CI @-@ -RSB- ; p = @ ) .


Grade @ or higher adverse events that occurred in more than @ % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( @ -LSB- @ % -RSB- of @ vs @ -LSB- @ % -RSB- of @ ) , leucopenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , hypertension ( @ -LSB- @ % -RSB- vs eight -LSB- @ % -RSB- ) , fatigue ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , anaemia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and abdominal pain ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


The incidence of grade @ or higher febrile neutropenia was low in both groups ( ten -LSB- @ % -RSB- vs eight -LSB- @ % -RSB- ) .


The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new standard second-line treatment for patients with advanced gastric cancer .


To evaluate the effect of statin treatment on strut coverage after drug-eluting stent ( DES ) implantation .


In this study , @ patients were randomly assigned to undergo sirolimus-eluting stent ( SES ) or biolimus-eluting stent ( BES ) implantation , after which patients were randomly treated with pitavastatin @ mg or pravastatin @ mg for @ months .


The degree of strut coverage was assessed by @-month follow-up optical coherence tomography , which was performed in @ DES-implanted patients .


The percentages of uncovered struts were @ % in pitavastatin-treated patients ( n = @ ) and @ % in pravastatin-treated patients ( n = @ ; p = @ ) .


A lower percentage of uncovered struts was significantly correlated with a lower follow-up low-density lipoprotein ( LDL ) cholesterol level ( r = @ ; p = @ ) and a greater decline of the LDL cholesterol level ( r = -@ ; p = @ ) in SES-implanted patients , but not in BES-implanted patients .


In SES-implanted patients , the percentage of uncovered struts was significantly lower among those with LDL cholesterol levels of less than @ mg/dL after @ months of follow-up ( p = @ ) , but no significant difference in this variable according to the follow-up LDL cholesterol level was noted among BES-implanted patients ( p = @ ) .


Lower follow-up LDL cholesterol levels , especially those less than @ mg/dL , might have a protective effect against delayed strut coverage after DES implantation .


This vascular healing effect of lower LDL cholesterol levels could differ according to the DES type .


This study evaluated the efficacy of a cancer geneticsspecific questionnaire in facilitating communication about , awareness of , and management of psychosocial problems , as well as in lowering distress levels .


Individuals referred to genetic counseling for cancer at two family cancer clinics in The Netherlands were randomly assigned to an intervention or a control group .


All participants completed the psychosocial questionnaire before counseling .


In the intervention group , the counselors received the results of this questionnaire before the counseling session .


All sessions were audiotaped for content analysis .


Primary outcomes were the frequency with which psychosocial problems were discussed , the genetic counselors awareness of these problems , and their management .


Secondary outcomes included cancer worries and psychological distress , duration and dynamics of the counseling , and satisfaction .


The frequency with which psychosocial problems were discussed with @ participating counselees was significantly higher in the intervention group ( n = @ ) than in the control group ( n = @ ; P = @ ) , as was the counselors awareness of psychosocial problems regarding hereditary predisposition ( P < @ ) , living with cancer ( P = @ ) , and general emotions ( P < @ ) .


Counselors initiated more discussion of psychosocial problems in the intervention group ( P < @ ) , without affecting the length of the counseling session .


No significant differences were found on management ( P = @ ) .


The intervention group reported significantly lower levels of cancer worries ( p = @ ) and distress ( p = @ ) after counseling .


The routine assessment of psychosocial problems by questionnaire facilitates genetic counselors recognition and discussion of their clients psychosocial problems and reduces clients distress levels .


To pilot the feasibility of a prenatal lifestyle intervention to modify physical activity and diet among pregnant overweight and obese Hispanic women , with the aim of reducing risk factors for gestational diabetes mellitus .


Women were randomized either to a lifestyle intervention ( n = @ , @ % ) , consisting of a culturally and linguistically modified , motivationally targeted , individually tailored @-month prenatal programme , or to standard care ( n = @ , @ % ) .


Bilingual and bicultural health educators encouraged women to achieve guidelines for physical activity , decrease saturated fat and increase dietary fibre .


Outcomes included gestational weight gain , infant birth weight and biomarkers associated with insulin resistance .


Patient retention up to delivery was @ % in both study groups .


The lifestyle intervention attenuated the pregnancy-associated decline in moderate-intensity physical activity , but differences between groups were not significant ( mean se -@ @ vs -@ @ metabolic equivalent of task h/week ; P = @ ) .


Vigorous-intensity activity increased during the course of pregnancy in the lifestyle intervention group ( mean se @ @ metabolic equivalent of task h/week ) and declined in the standard care group ( -@ @ metabolic equivalent of task h/week ; P = @ ) .


The lifestyle intervention group also had slightly lower gestational weight gain and infant birth weights compared with the standard care group ; however , these differences were not statistically significant .


There were no statistically significant differences in biomarkers of insulin resistance between groups .


Findings suggest that a motivationally matched lifestyle intervention is feasible and may help attenuate pregnancy-related decreases in vigorous physical activity in a population of overweight and obese Hispanic women .


The intervention protocol can readily be translated into clinical practice in underserved and minority populations .


Chronic ischemia related occult systolic dysfunction of the right ventricle is difficult to detect using traditional echocardiography .


The aim of this study was to verify the diagnostic value of speckle-tracking echocardiography in proximal right coronary artery ( pRCA ) lesion-induced right ventricular ( RV ) occult dysfunction .


One hundred forty-two patients undergoing elective coronary angiography for suspected coronary artery disease were divided into two groups according to involvement of the right coronary artery .


In further analysis , significant stenosis before the acute marginal branch was defined as pRCA involvement and compared with a control group .


Global longitudinal strain and RV free wall longitudinal train ( RVLS-FW ) were measured using speckle-tracking echocardiography .


Other traditional parameters to evaluate RV function were also measured .


Eighty-seven patients in the right coronary artery group ( @ % ) displayed significant decreases in the magnitudes of both global longitudinal strain ( -@ @ % vs -@ @ % , P = @ ) and RVLS-FW ( -@ @ % vs -@ @ % , P = @ ) , independent of other parameters .


Conversely , when focusing on pRCA involvement , only RVLS-FW showed significant attenuation in the group with pRCA involvement ( -@ @ % vs -@ @ % , P = @ ) .


On multivariate analysis , RVLS-FW was still independently lower in the group with pRCA involvement ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


The results of this study show that RVLS-FW was independently impaired in patients with coronary artery disease with right coronary artery stenosis , especially with involvement of the acute marginal branches .


RV strain can be used to detect occult RV dysfunction in patients with stable coronary artery disease .


Young women attending university are at substantial risk for being sexually assaulted , primarily by male acquaintances , but effective strategies to reduce this risk remain elusive .


We randomly assigned first-year female students at three universities in Canada to the Enhanced Assess , Acknowledge , Act Sexual Assault Resistance program ( resistance group ) or to a session providing access to brochures on sexual assault , as was common university practice ( control group ) .


The resistance program consists of four @-hour units in which information is provided and skills are taught and practiced , with the goal of being able to assess risk from acquaintances , overcome emotional barriers in acknowledging danger , and engage in effective verbal and physical self-defense .


The primary outcome was completed rape , as measured by the Sexual Experiences Survey-Short Form Victimization , during @ year of follow-up .


A total of @ women were assigned to the resistance group and @ women to the control group .


Of the women assigned to the resistance group , @ % attended at least three of the four units .


The @-year risk of completed rape was significantly lower in the resistance group than in the control group ( @ % vs. @ % ; relative risk reduction , @ % -LSB- @ % confidence interval , @ to @ -RSB- ; P = @ ) .


The @-year risk of attempted rape was also significantly lower in the resistance group ( @ % vs. @ % , P < @ ) .


A rigorously designed and executed sexual assault resistance program was successful in decreasing the occurrence of rape , attempted rape , and other forms of victimization among first-year university women .


( Funded by the Canadian Institutes of Health Research and the University of Windsor ; SARE ClinicalTrials.gov number , NCT@ . )


Lace-up ankle braces reduce the incidence of ankle sprains and have been hypothesized to do so through both mechanical and neuromuscular mechanisms .


To determine the effect of lace-up ankle braces on surface electromyography ( sEMG ) measures during walking in adults with chronic ankle instability ( CAI ) .


Randomized crossover .


Laboratory .


Fifteen adults with CAI .


Surface EMG activity was recorded from the anterior tibialis , peroneus longus , lateral gastrocnemius , rectus femoris , biceps femoris and gluteus medius during treadmill walking with and without lace-up ankle braces .


The dependent variables were sEMG amplitude @ ms pre - and @ ms post-initial contact , time of activation relative to initial contact , and percent of activation across the stride cycle .


When compared to no brace , ankle bracing resulted in lower pre-contact amplitude of the peroneus longus ( p = @ ) .


The anterior tibialis , peroneus longus , rectus femoris , and gluteus medius were activated later relative to initial contact ( p < @ ) .


The peroneus longus and rectus femoris were activated for a shorter percentage of the stride cycle ( p < @ ) .


Braces cause a change in neuromuscular activity during walking .


Clinicians should be aware of these changes when prescribing braces , as it may relate to the mechanism in which braces decrease sprains .


Osteoarthritis ( OA ) is a heterogeneous group of conditions with disturbed integrity of articular cartilage and changes in the underlying bone .


The pathogenesis of OA is multifactorial and not just a disease of older people .


Hydroxychloroquine ( HCQ ) is a disease-modifying anti-rheumatic drug ( DMARD ) typically used for the treatment of various rheumatic and dermatologic diseases .


Three studies of HCQ in OA , including one abstract and one letter , are available and use a wide variety of outcome measures in small patient populations .


Despite initial evidence for good efficacy of HCQ , there has been no randomized , double-blind , and placebo-controlled trial in a larger patient group .


In the European League Against Rheumatism ( EULAR ) , evidence-based recommendations for the management of hand OA , HCQ was not included as a therapeutic option because of the current lack of randomized clinical trials .


OA TREAT is an investigator-initiated , multicenter , randomized , double-blind , placebo-controlled trial .


A total of @ subjects with inflammatory and erosive hand OA , according to the classification criteria of the American College of Rheumatology ( ACR ) , with recent X-ray will be recruited across outpatient sites , hospitals and universities in Germany .


Patients are randomized @:@ to active treatment ( HCQ @ to @ mg per day ) or placebo for @ weeks .


Both groups receive standard therapy ( non-steroidal anti-inflammatory drugs -LSB- NSAID -RSB- , coxibs ) for OA treatment , taken steadily two weeks before enrollment and continued further afterwards .


If disease activity increases , the dose of NSAID/coxibs can be increased according to the drug recommendation .


The co-primary clinical endpoints are the changes in Australian-Canadian OA Index ( AUSCAN , German version ) dimensions for pain and hand disability at week @ .


The co-primary radiographic endpoint is the radiographic progression from baseline to week @ .


A multiple endpoint test and analysis of covariance will be used to compare changes between groups .


All analyses will be conducted on an intention-to-treat basis .


The OA TREAT trial will examine the clinical and radiological efficacy and safety of HCQ as a treatment option for inflammatory and erosive OA over @ months .


OA TREAT focuses on erosive hand OA in contrast to other current studies on symptomatic hand OA , for example , HERO -LSB- Trials @:@ , @ -RSB- .


Despite the often social nature of smoking , relatively little research has been conducted on the relationship between smoking and social anxiety disorder ( SAD ) .


Participants ( N = @ ) included @ smokers without current mental health disorders , @ smokers with SAD , and @ smokers who met criteria for other anxiety disorder diagnoses ( e.g. , panic disorder or generalized anxiety disorder , but not SAD ) .


Nicotine and placebo patches were administered to participants in a counterbalanced manner across two assessment days .


Urge and craving were assessed before and after a @-h nicotine absorption/deprivation period .


Compared to smokers without current mental health disorders , smokers with SAD did not report greater nicotine dependence , but did endorse greater motivation to use nicotine to avoid negative outcomes .


In addition , after controlling for demographic variables , smoking characteristics , pre-deprivation urge and craving , and other anxiety/depression symptoms , social anxiety symptoms uniquely predicted urge and craving in the placebo patch condition ; however , social anxiety had no influence on urge and craving in the nicotine patch condition .


These findings suggest that one potential reason that smokers with SAD may have worse cessation outcomes is that they may experience higher levels of craving and urge to smoke during quit attempts .


Thus , during a quit attempt , particularly in the absence of nicotine replacement therapy , smokers with SAD are likely to benefit from additional treatment aimed at managing or reducing their social anxiety symptoms .


To analyze recurrence patterns in patients with cancer of the esophagus or gastroesophageal junction treated with either preoperative chemoradiotherapy ( CRT ) plus surgery or surgery alone .


Recurrence pattern was analyzed in patients from the previously published CROSS I and II trials in relation to radiation target volumes .


CRT consisted of five weekly courses of paclitaxel and carboplatin combined with a concurrent radiation dose of @ Gy in @-Gy fractions to the tumor and pathologic lymph nodes with margin .


Of the @ patients included from @ to @ , @ were available for analysis .


Histology was mostly adenocarcinoma ( @ % ) .


Of the @ patients who underwent resection , @ % were allocated to surgery and @ % to CRT plus surgery .


On January @ , @ , after a minimum follow-up of @ months ( median , @ months ) , the overall recurrence rate in the surgery arm was @ % versus @ % in the CRT plus surgery arm .


Preoperative CRT reduced locoregional recurrence ( LRR ) from @ % to @ % ( P < @ ) and peritoneal carcinomatosis from @ % to @ % ( P < @ ) .


There was a small but significant effect on hematogenous dissemination in favor of the CRT group ( @ % v @ % ; P = @ ) .


LRR occurred in @ % within the target volume , in @ % in the margins , and in @ % outside the radiation target volume .


In @ % , the exact site in relation to the target volume was unclear .


Only @ % had an isolated infield recurrence after CRT plus surgery .


Preoperative CRT in patients with esophageal cancer reduced LRR and peritoneal carcinomatosis .


Recurrence within the radiation target volume occurred in only @ % , mostly combined with outfield failures .


To explore the efficacy and feasibility of dog days moxibustion plaster therapy in treatment of allergic rhinitis of different patterns/syndromes .


Allergic rhinitis of lung deficiency and invasion of cold , spleen qi deficiency and kidney yang deficiency , @ patients for each pattern/syndrome were randomized into a plaster therapy group and a nasal spray group , @ cases in each one .


In the plaster therapy group , according to the pattern/syndrome differentiation , with literature retrieval method , @ acupoints of high frequency utility in clinic were selected as one group in acupoint plaster therapy .


For lung deficiency and invasion of cold pattern/syndrome , Feishu ( BL @ ) , Fengmen ( BL @ ) and Hegu ( LI @ ) were selected .


For spleen qi deficiency pattern/syndrome , Pishu ( BL @ ) , Zusanli ( ST @ ) and Dazhui ( GV @ ) were selected .


For kidney yang deficiency pattern / syndrome , Shenshu ( BL @ ) , Dingchuan ( EX-B @ ) and Bailao ( EX-HN @ ) were selected .


Separately , on July @ , @ , July @ , @ , August @ , @ and August @ , @ , the aucpoint plaster therapy was applied , @ to @ h ( @ to @ h for children ) each time .


In the nasal spray group , beclometasone dipropionate aqueous nasal spray , @ presses one nostril each time , @ to @ times a day , continuously for @ weeks .


The symptom score and efficacy were compared before and after treatment in the patients of the two groups .


The symptom scores of @ patterns/syndromes were all apparently improved after treatment as compared with those before treatment in the patients of the two groups ( all P < @ ) , and the result in the plaster therapy group was better than that of the nasal spray group ( P < @ , P < @ ) .


For lung deficiency and invasion of cold pattern/syndrome , the total effective rate was @ % ( @/@ ) in the plaster therapy group , better than @ % ( @/@ ) in the nasal spray group ( P < @ ) .


For spleen qi deficiency pattern/syndrome , the total effective rate was @ % ( @/@ ) in the plaster therapy group , obviously better than @ % ( @/@ ) in the nasal spray group ( P < @ ) .


For kidney yang deficiency pattern/syndrome , the total effective rate was @ % ( @/@ ) in the plaster therapy group , better than @ % ( @/@ ) in the nasal spray group ( P < @ ) .


The dog days moxibustion plaster therapy achieves definite efficacy on allergic rhinitis at the acupoints selected based on the differentiation of different patterns/syndromes and the efficacy is better than beclometasone dipropionate aqueous nasal spray .


Cytotoxic chemotherapy is widely used for advanced , unresectable pancreatic and other gastrointestinal foregut neuroendocrine tumours ( NETs ) and the most commonly used regimen combines @-fluorouracil with streptozocin .


The NET@ trial was designed to investigate whether capecitabine combined with streptozocin was an acceptable regimen with or without adding cisplatin .


Patients with advanced , unresectable NETs of pancreatic , gastrointestinal foregut or unknown primary site were randomised to receive three-weekly capecitabine ( Cap ) @ mg/m ( @ ) twice daily orally , streptozocin ( Strep ) @ g/m ( @ ) intravenously on day @ , with or without cisplatin ( Cis ) @ mg/m ( @ ) intravenously on day @ .


The primary outcome measure was objective response .


Secondary outcome measures included progression-free and overall survival , quality of life , toxicity and biochemical response .


@ ( @ CapStrep , @ CapStrepCis ) patients were randomised .


Best objective response rate was @ % ( @ % confidence interval ( CI ) = @-@ % ) with CapStrep and @ % ( @ % CI = @-@ @ % ) with CapStrepCis .


Disease-control rate was @ % with CapStrep and @ % with CapStrepCis .


The estimated median progression-free and overall survival were @ and @ months for CapStrep and @ and @ months for CapStrepCis .


@ % of CapStrep and @ % of CapStrepCis patients experienced grade @ adverse events .


The efficacies of the novel CapStrepCis regimens were very similar .


CapStrep was better tolerated than CapStrepCis .


The trial was registered as EudraCT : @-@-@ and ISRCTN : @ .


The Trendelenburg position has a dramatic effect on circulation , consequently increasing cerebral and intraocular pressure .


We evaluated whether modifying the Trendelenburg position would minimize the increase in intraocular pressure .


In this prospective , randomized , controlled study we compared intraocular pressure in patients undergoing robot-assisted laparoscopic radical prostatectomy while in the Trendelenburg position or the modified Z Trendelenburg position .


In group @ intraocular pressure , blood pressure and endotracheal CO@ were measured in the patient at anesthesia induction ( time @ ) , before positioning ( time @ ) , and while in the Trendelenburg position ( time @ ) and in the modified Z Trendelenburg position ( time @ ) .


They were also measured after pneumoperitoneum ( time @ ) , every @ minutes ( times @ to @ ) , while supine at the end of pneumoperitoneum ( time @ ) and before awakening ( time @ ) .


We modified the Trendelenburg position by placing the head and shoulders horizontally .


Group @ included @ patients in the modified Z Trendelenburg position .


Group @ included @ patients in the Trendelenburg position .


No difference was found in patient demographics or surgical outcomes .


Median intraocular pressure was in the low normal range at times @ and @ , and increased in time @ in each group .


From time @ intraocular pressure decreased and at all time points it was significantly lower in group @ by a mean of @ mm Hg ( @ % CI -@ -@ , p < @ ) .


At time @ mean intraocular pressure decreased to normal ( @ mm Hg ) in group @ but remained in the hypertensive range ( @ mm Hg ) in group @ .


At time @ mean intraocular pressure was @ mm Hg in each group .


Blood pressure was significantly lower in group @ with a mean reduction in systolic and diastolic pressure of @ and @ mm Hg , respectively .


Our results suggest that modifying the Trendelenburg position during robot-assisted laparoscopic radical prostatectomy has a significant positive effect on patient neuro-ocular safety by lowering intraocular pressure and accelerating its recovery to the normal range without affecting the operation .


To assess whether bezafibrate increases fatty acid oxidation ( FAO ) and lowers heart rate ( HR ) during exercise in patients with carnitine palmitoyltransferase ( CPT ) II and very long-chain acyl-CoA dehydrogenase ( VLCAD ) deficiencies .


This was a @-month , randomized , double-blind , crossover study of bezafibrate in patients with CPT II ( n = @ ) and VLCAD ( n = @ ) deficiencies .


Primary outcome measures were changes in FAO , measured with stable-isotope methodology and indirect calorimetry , and changes in HR during exercise .


Bezafibrate lowered low-density lipoprotein , triglyceride , and free fatty acid concentrations ; however , there were no changes in palmitate oxidation , FAO , or HR during exercise .


Bezafibrate does not improve clinical symptoms or FAO during exercise in patients with CPT II and VLCAD deficiencies .


These findings indicate that previous in vitro studies suggesting a therapeutic potential for fibrates in disorders of FAO do not translate into clinically meaningful effects in vivo .


This study provides Class I evidence that bezafibrate @ mg @ times daily is ineffective in improving changes in FAO and HR during exercise in adults with CPT II and VLCAD deficiencies .


The aim of the study was to evaluate the safety and efficacy of early feeding after cesarean delivery under different anesthetic methods .


Two hundred women with elective cesarean delivery were randomly assigned to early oral feeding ( EOF ) or routine oral feeding ( ROF ) groups .


EOF patients were informed that they could begin taking fluids orally ( regime I ) as soon as @ hours after the delivery and then gradually progress to solid foods ( regime III ) , if tolerated .


ROF patients were informed that they could start regime I right after bowel sounds were heard on examination and then gradually move on to regime III .


Hospitalization time and total time to ambulation ( primary outcomes ) , gasstool discharge time and onset of bowel sounds ( secondary outcomes ) were compared in groups A -LSB- EOF patients after regional anesthesia ( n = @ ) -RCB- , B -LSB- EOF patients after general anesthesia ( n = @ ) -RCB- , C -LSB- ROF patients after regional anesthesia ( n = @ ) -RCB- and @ -LSB- ROF patients after general anesthesia ( n = @ ) -RSB- .


There were significant differences in primary and secondary outcomes between group A and the remaining groups , especially group D.


The status of patients from group B was not better than group C.


In fact , the latter were discharged home sooner and passage of gas , as well as initiation of regime I occurred earlier as compared to the former


Cesarean section under regional anesthesia and encouragement of oral feeding @ hours after the operation should be recommended in order to acnieve postoperative recovery and early hospital discharge .


Routine oral feeding ( right after bowel sounds are heard on examination ) after cesarean section under general anesthesia should be the last choice .


Hypoglycemia is a leading risk of glucose-lowering therapy .


Treatment with insulin glargine compared with standard care early in the course of dysglycemia in the Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial provides information on the frequency and predictors of hypoglycemia in this setting .


A total of @,@ people with high cardiovascular risk and dysglycemia treated with one or no oral glucose-lowering agents were randomized to add glargine titrated to a fasting glucose level of @ mmol/L ( @ mg/dL ) or to use standard therapies .


Independent associations of both nonsevere hypoglycemia ( symptomatic and confirmed with a glucose level of @ mmol/L -LSB- @ mg/dL -RSB- ) and severe hypoglycemia with characteristics at baseline , treatment allocation , and average HbA@c were assessed by Cox proportional hazards models .


During a median follow-up period of @ years , @ % of participants reported nonsevere hypoglycemia , and @ % reported severe hypoglycemia .


Prior use of a sulfonylurea and allocation to glargine independently predicted a higher risk for both categories of participants .


Nonsevere events were independently associated with younger age , lower BMI , the presence of diabetes , and higher baseline HbA@c level .


Severe events were associated with older age , hypertension , higher serum creatinine level , and lower cognitive function , but not baseline glycemic status .


Progressively higher on-treatment HbA@c level was associated with a lower risk of nonsevere events in both treatment groups ; a lower risk of severe events in the glargine group , and a higher risk of severe events with standard care .


Hypoglycemia was relatively uncommon in the ORIGIN trial , but was more frequent with sulfonylurea use at baseline and allocation to glargine .


Nonsevere and severe events were associated with different clinical characteristics , awareness of which may guide individualized therapy .


Few studies were conducted on hepatitis B and C virus ( HBV and HCV , respectively ) risk factors among Chinese blood donors in recent years since voluntary donors replaced commercial donors .


A case-control survey was conducted in HBV - or HCV-positive and - negative donors from five blood centers in China between September @ and April @ .


Case status was defined by having a reactive result on Monolisa HBsAg Ultra ( Bio-Rad ) for HBV and Ortho anti-HCV EIA @ ( Johnson & Johnson ) for HCV .


Controls were randomly selected qualified blood donors matched to cases by donation month and blood center .


Specific test-seeking , medical-related , and behavioral risk factors were compared by HBV and HCV status using chi-square tests or Fisher 's exact tests with Bonferroni correction .


A total of @ HBV cases , @ HCV cases , and @ controls completed the survey ; response rates were @ , @ , and @ % , respectively .


HCV-positive donors were significantly more likely to report having a blood transfusion history ( @ % vs. @ % , p < @ ) and ever living with a person with illegal drug injection ( @ % vs. @ % , p < @ ) than controls .


Having intravenous and intramuscular injections in the past @ months and ever having a tattoo are marginal risk factors for HCV ( p values < @ ) .


No specific risk factor for HBV was identified .


History of previous transfusion and living with illegal drug users are risk factors for HCV infection among Chinese blood donors from five regions .


Test-seeking behavior is not associated with HBV or HCV infections .


Patients with a recent vertebrobasilar transient ischaemic attack or ischaemic stroke and vertebral artery stenosis of at least @ % have a high risk of future vertebrobasilar stroke .


Stenting of vertebral artery stenosis is promising , but of uncertain benefit .


We investigated the safety and feasibility of stenting of symptomatic vertebral artery stenosis of at least @ % , and assessed the rate of vascular events in the vertebrobasilar supply territory to inform the design of a phase @ trial .


Between Jan @ , @ , and April @ , @ , patients with a recent transient ischaemic attack or minor stroke associated with an intracranial or extracranial vertebral artery stenosis of at least @ % were enrolled from seven hospitals in the Netherlands in a phase @ open-label trial with masked assessment of outcome .


Patients were randomly allocated in a @:@ ratio to stenting plus best medical treatment or best medical treatment alone by the local investigators using a web-based randomisation system .


The primary outcome was the composite of vascular death , myocardial infarction , or any stroke within @ days after the start of treatment .


The secondary outcomes were stroke in the supply territory of the symptomatic vertebral artery during follow-up , the composite outcome during follow-up , and the degree of stenosis in the symptomatic vertebral artery at @ months .


The trial is registered , number ISRCTN@ .


The trial was stopped after inclusion of @ patients because of new regulatory requirements , including the use of a few prespecified stent types and external monitoring , for which no funding was available .


@ patients were assigned to stenting and @ to medical treatment alone .


Three patients in the stenting group had vascular death , myocardial infarction , or any stroke within @ days after the start of treatment ( @ % , @ % CI @-@ ) versus one patient in the medical treatment group ( @ % , @-@ ) .


During a median follow-up of @ years ( IQR @-@ ) , seven ( @ % , @ % CI @-@ ) patients in the stenting group and four ( @ % , @-@ ) in the medical treatment group had a stroke in the territory of the symptomatic vertebral artery ; @ ( @ % ) patients in the stenting group and ten ( @ % ) in the medical treatment group had vascular death , myocardial infarction , or any stroke .


The small size of the vertebral artery and stent artifacts did not allow exact grading of restenosis on CT angiography .


During the complete period of follow-up , there were @ serious adverse events ( eight strokes ) in the stenting group and @ ( seven strokes ) in the medical treatment alone group .


Stenting of symptomatic vertebral artery stenosis is associated with a major periprocedural vascular complication in about one in @ patients .


In the population we studied , the risk of recurrent vertebrobasilar stroke under best medical treatment alone was low , questioning the need for and feasibility of a phase @ trial .


To evaluate preliminarily the efficacy on functional constipation treated with electroacupuncture of different acupoint prescriptions .


One hundred and four patients were randomized into a front-mu and back-shu points group ( @ cases ) , a he-sea points group ( @ cases ) , a he-sea , front-mu and back-shu points group ( @ cases ) and a western medication control group ( @ cases ) .


In the front-mu and back-shu points group , electroacupuncture was applied at bilateral Tianshu ( ST @ ) and Dachangshu ( BL @ ) .


In the he-sea points group , electroacupuncture was applied at bilateral Quchi ( LI @ ) and Shangjuxu ( ST @ ) .


In the he-sea , front-mu and back-shu points group , electroacupuncture was applied at unilateral Tianshu ( ST @ ) , Dachangshu ( BL @ ) , Quchi ( LI @ ) and Shangjuxu ( ST @ ) .


In the three groups above , the treatment was given @ times a week in the first two weeks and @ times a week in the next two weeks .


In the western medication control group , mosapride citrate tablets were prescribed for oral administration , @ table ( @ mg ) each time , @ times a day , continuously for @ weeks .


The period of research was @ weeks , including @ week for baseline evaluation , @ weeks for treatment and @ weeks for follow-up .


The weekly defecation frequency was taken as primary index , while the defecation difficulty and life quality score were taken as the secondary indices for the efficacy evaluation after treatment and in follow-up .


According to the intention-to-treat ( ITT ) analytic principle , @ cases were all enrolled in the final analysis .


( @ ) After treatment , the weekly frequency of defecation was all increased significantly in the four groups ( P < @ , P < @ ) .


The efficacy of the three electroacupuncture groups was similar to that of western medication control group ( P > @ ) .


In follow-up , the increasing effect on the weekly frequency of defecation was maintained in the he-sea points group ( P < @ ) , superior to the front-mu and back-shu points group and the western medication control group ( P < @ , P < @ ) ; the weekly frequency of defecation was not improved in the rest three groups ( P > @ ) .


( @ ) After treatment , defecation difficulty was relieved in the he-sea points group , the he-sea , front-mu and back-shu points group and the western medication control group ( P < @ , P < @ ) .


In follow-up , the improvements were still significant in the he-sea points group and the he-sea , front-mu and back-shu points group ( both P < @ ) .


( @ ) After treatment , the life quality score was significantly improved in the patients of the he-sea points group ( P < @ ) .


The difference was not significant in the rest three groups as compared with that before treatment ( all P > @ ) .


The weekly frequency of defecation is increased effectively after treatment in the three electroacupuncture groups and the efficacy is similar to mosapride citrate tablets .


The bilateral Quchi ( LI @ ) and Shangjuxu ( ST @ ) in he-sea acupoints increase significantly the weekly frequency of defecation , relieve defecation difficulty and improve life quality .


Acupuncture efficacy is sustained for @ weeks .


This acupoints prescription is the best in the treatment of functional constipation .


Management of diabetes in elderly subjects is complex and careful management of glucose levels is of particular importance in this population because of an increased risk of diabetes-related complications and hypoglycaemia .


The aim of this study was to evaluate the pharmacokinetic and pharmacodynamic properties of insulin degludec ( IDeg ) , a basal insulin with an ultra-long duration of action , in elderly subjects with type @ diabetes compared with younger adults .


This trial was a randomised , double-blind , two-period , crossover trial conducted in a single centre and included both inpatient and outpatient periods .


Subjects were men and women aged @-@ years inclusive ( younger adult group ) or @ years ( elderly group ) with type @ diabetes who received IDeg ( @ U/kg ) via subcutaneous injection in the thigh once-daily for six days .


Following @-day dosing , a @-hour euglycaemic glucose clamp procedure was conducted to evaluate the steady-state pharmacodynamic effects of IDeg .


Blood samples were taken for pharmacokinetic analysis up to @ h post-dose .


Pharmacokinetic endpoints included the total exposure of IDeg , ie the area under the IDeg serum concentration curve during one dosing interval at steady state ( AUC ( IDeg , , SS ) ) ( = @-@ h , equal to one dosing interval ) and the maximum IDeg serum concentration at steady state ( C ( max , IDeg , SS ) ) .


Pharmacodynamic endpoints included the total glucose-lowering effect of IDeg , ie the area under the glucose infusion rate ( GIR ) curve at steady state ( AUC ( GIR , , SS ) ) , and the maximum GIR at steady state ( GIR ( max , IDeg , SS ) ) .


Total exposure ( AUC ( IDeg , , SS ) ) and maximum concentration ( C ( max , IDeg , SS ) ) of IDeg were comparable between elderly subjects and younger adults .


Estimated mean age group ratios ( elderly/younger adult ) for AUC ( IDeg , , SS ) and C ( max , IDeg , SS ) and corresponding two-sided @ % confidence intervals ( CIs ) were @ ( @ % CI @-@ @ ) and @ ( @ % CI @-@ @ ) , respectively .


Mean AUC ( IDeg,@-@h , SS ) / AUC ( IDeg , , SS ) was @ % in both younger adult and elderly subjects , showing that in both age groups IDeg exposure was evenly distributed across the first and second @ h of the @-hour dosing interval .


No statistically significant differences were observed between younger adult and elderly subjects with regard to AUC ( GIR , , SS ) ( the primary endpoint of this study ) and GIR ( max , IDeg , SS ) .


Estimated mean age group ratios ( elderly/younger adult ) for AUC ( GIR , , SS ) and GIR ( max , IDeg , SS ) and corresponding two-sided @ % CIs were @ ( @ % CI @-@ @ ) and @ ( @ % CI @-@ @ ) , respectively .


Duration of action was beyond the clamp duration of @ h in all subjects .


The exposure of IDeg at steady state during once-daily dosing was similar in younger adult and elderly subjects .


The glucose-lowering effect of IDeg was numerically lower in elderly subjects compared with younger adults , but no significant differences were observed between age groups .


The ultra-long pharmacokinetic and pharmacodynamic properties of IDeg observed in younger adults were preserved in elderly subjects with type @ diabetes .


Clinical trials.gov number : NCT@ .


This study sought to examine the possible drug-drug interactions between clopidogrel and morphine .


Because morphine-the recommended treatment for pain of myocardial infarction-is associated with poor clinical outcome , we hypothesized that morphine lowers the plasma levels of clopidogrel active metabolite as well as its effects on platelets .


Twenty-four healthy subjects received a loading dose of @ mg clopidogrel together with placebo or @ mg morphine intravenously in a randomized , double-blind , placebo-controlled , cross-over trial .


Pharmacokinetics was determined by liquid chromatography tandem mass spectrometry , and clopidogrel effects were measured by platelet function tests .


Morphine injection delayed clopidogrel absorption ( p = @ ) and reduced the area under the curve levels of its active metabolite by @ % ( p = @ ) .


Morphine delayed the maximal inhibition of platelet aggregation on average by @ h ( n = @ ; p < @ ) .


Residual platelet aggregation was higher @ to @ h after morphine injection ( n = @ ; p < @ ) .


Furthermore , morphine delayed the inhibition of platelet plug formation under high shear rates ( P@Y-Innovance ; n = @ ; p < @ ) and abolished the @-fold prolongation in collagen adenosine diphosphate-induced closure times seen in extensive and rapid metabolizers ( n = @ ; p = @ ) .


Morphine delays clopidogrel absorption , decreases plasma levels of clopidogrel active metabolite , and retards and diminishes its effects , which can lead to treatment failure in susceptible individuals .


( Drug/Drug Interactions of Aspirin and P@Y@-inhibitors ; NCT@ ) .


In STEMI , grade-@ ischemia ( G@ ) on admission ECG predicts larger infarct size ( IS ) than grade-@ ( G@ ) .


We evaluated whether pre-hospital G@ and its temporal behavior are associated with IS and salvage after pPCI .


In @ STEMI patients , pre-hospital and pre-PCI ECGs were classified as G@ or G@ .


IS was assessed by single-photon emission computed tomography ( SPECT ) at @days .


In @ patients , pre-PCI SPECT was available to determine myocardium at risk ( MaR ) .


G@ criteria were met by @ , and G@ by @ patients .


G@ was independently associated with IS ( p = @ ) .


With ST resolution ( STR ) group as a reference , G@ - > G@ , G@ - > G@ and G@ - > G@ were associated with larger IS ( B = @ , p = @ ; B = @ , p = @ ; B = @ , p < @ , respectively ) , whereas G@ - > G@ was not .


Salvage was similar between G@ and G@ on pre-hospital ECG if treated early , however lower for G@ when treated later ( > @ h ) ; @ % ( @-@ ) vs @ % ( @-@ ) ; p = @ .


Development or persistence of G@ is associated with larger IS and less salvage , but decreasing grade G@ - > G@ was not .


The prevalence of type @ diabetes has increased dramatically in the last decade , and is continuing to rise .


It is a chronic condition , often related to obesity , diet and sedentary lifestyles , and can lead to significant health complications , disability and early death .


Diabetes is commonly associated with depression , which can impact significantly on a person 's ability to manage their illness and , consequently , on disease outcomes .


Disease self-management is fundamental in diabetes and requires support from multiple health professionals and the active participation of the person , including in maintaining a healthy lifestyle .


The Whole Person Model was developed in order to integrate emotional and behavioural aspects into a self-management program for people with type @ diabetes .


Here we describe a study designed to test the efficacy of the Whole Person Model of disease self-management in type @ diabetes .


In a parallel-group randomised trial , @ people with type @ diabetes of between @-@ years duration will be recruited via invitation through the Australian National Diabetes Services Scheme .


Participants will undergo baseline assessment , followed by randomisation to either intervention or control condition .


Control participants will receive fact sheets containing key information about diabetes self-management .


The intervention group will receive the INSPIRED ( Individual Support & Resources for Diabetes ) Manual and be assigned a Health Coach .


The INSPIRED Manual consists of six modules that provide key information about diabetes and disease management using the Whole Person Model .


Engagement is facilitated by interactive tasks and contact with a Health Coach over seven weeks -- an introductory face-to-face session , and six subsequent contacts by phone following each module .


Follow-up assessments occur at @ weeks ( post-intervention ) and @ weeks .


Primary outcomes include blood glucose management ( HbA@c ) , weight and mood .


Secondary outcomes include level of exercise , confidence to manage diabetes , and psychosocial well-being .


The Whole Person Model is designed to enable health professionals to address mood disturbance without pathologizing any disorders and , in the context of the chronic illness , empowering behavior change and self-management .


If proven effective , this model will strengthen capacity of the healthcare workforce to foster and support effective diabetes self-management .


Sleep disturbances are common following traumatic brain injury ( TBI ) .


The Pittsburgh Sleep Quality Index ( PSQI ) is a widely used measure of sleep quality that has been used in numerous populations .


Although this measure has been used in TBI research , there are few studies examining the psychometric properties in this population .


The current study examined the factor structure of the PSQI in a sample of persons with TBI and tested the one , two , and three factor models derived from previous studies in other populations .


A telephone interview was conducted with @ individuals who had sustained a TBI .


All participants were approximately one year post-injury .


Factor analyses were conducted ( exploratory and confirmatory ) to examine the factor structure of the PSQI .


Results confirm the fit of models previously tested in the literature but also reveal an alternative conceptualization of sleep containing both qualitative and quantitative factors .


While the @-factor model best fits the data in this TBI sample , the use of a @-factor model is acceptable and may be more clinically relevant due to the grouping of time-related variables that could provide important information with regard to circadian rhythm disorders .


To compare the efficacy and safety of recombinant streptokinase ( rSK ) and phenylephrine-based suppositories in acute hemorrhoidal disease .


A multicenter ( @ sites ) , randomized ( @:@ ) , open , parallel groups , active controlled trial was done .


After inclusion , subjects with acute symptoms of hemorrhoids , who gave their written , informed consent to participate , were centrally randomized to receive , as outpatients , rSK ( @ IU ) or @ % phenylephrine suppositories , which had different organoleptic characteristics .


Treatment was administered by the rectal route , one unit every @ h during @ h for rSK , and up to a maximum of @ d ( @ suppositories ) for phenylephrine .


Evaluations were performed at @ , @ and @ d post-inclusion .


The main end-point was the @ ( th ) - day complete clinical response ( disappearance of pain and edema , and @ % reduction of the lesion size ) .


Time to response and need for thrombectomy were secondary efficacy variables .


Adverse events were evaluated too .


@ ( th ) day complete response rates were @/@ ( @ % ) and @/@ ( @ % ) with rSK and phenylephrine suppositories , respectively .


This @ % difference ( @ % CI : @-@ @ ) was highly significant ( P < @ ) .


The advantage was detected since the early @ ( rd ) day evaluation ( @ % vs @ % for the rSK and active control groups , respectively ; P < @ ) and was kept even at the late @ ( th ) day assessment ( @ % vs @ % for rSK and phenylephrine , respectively ; P < @ ) .


Time for complete response was significantly shorter ( P = @ ; log-rank test ) in the rSK group ( median : @ d ; @ % CI : @-@ @ ) with respect to the active control ( median : @ d ; @ % CI : @-@ @ ) .


Thrombectomy was necessary in @/@ and @/@ patients with baseline thrombosis in the rSK and phenylephrine groups , respectively ( P = @ ) .


There were no adverse events attributable to the experimental treatment .


rSK suppositories showed a significant advantage over a widely used over-the-counter phenylephrine preparation for the treatment of acute hemorrhoidal illness , with an adequate safety profile .


The impact of different approaches to fluid management during intraoperative volume resuscitation in patients undergoing major elective surgery is poorly defined .


We compared volume effectiveness of crystalloid and colloid substitution aimed to maintain the cardiac index ( CI ) between @ and @ l/min/m ( @ ) as measured by transesophageal Doppler ( TED ) .


A total of @ urological patients were enrolled in the prospective randomized trial and then randomized into @ groups , one with volume therapy based on crystalloids ( n = @ ) and the other with colloids ( n = @ ) .


A TED probe was inserted and then hemodynamic optimization ( therapy with Ringer 's solution or hydroxyethyl starch @ % @/@ @ and administration of vasoactive drugs ) was started according to TED variables to maintain the CI between @ and @ l/min/m ( @ ) .


We observed high incidence of CI < @ l/min/m ( @ ) after induction of anesthesia ( @ % ) in both groups .


There were no significant differences in demographic characteristics , ASA classification , length of surgery , estimated blood loss and the CI during surgery .


To maintain the CI within the requested interval , significantly different amounts of crystalloids were needed as compared to colloid ( median : @ ml vs @ ml ) .


In the CRY group , more patients were treated by vasodilatators ( @ vs @ % ) .


The study confirmed that crystalloids and colloids are effective in correcting flow-related perfusion abnormalities .


The significant difference between volumes of crystalloids and colloids proved their different characteristics such as unequal distribution between compartments .


The expansion of therapeutic algorithm by using vasoactive drugs allows us to avoid adverse events resulting from fluid overload ( Tab .


@ , Fig. @ , Ref .


Pedometry is an objective method to analyse part of physical activity .


The aims of this study were to evaluate physical activity ( by quantifying walking steps/day ) in Romanian chronic obstructive pulmonary disease ( COPD ) patients and healthy subjects .


A total of @ COPD patients ( GOLD stages III and IV ) and @ healthy subjects , divided by decades of age , wore pedometers for @ weeks .


Significant decrease of physical activity level was observed in COPD patients vs. control group ( @,@,@ vs. @,@,@ steps/day ) .


Walking performance of patients with COPD stage III was better than that of patients with COPD stage IV .


For both groups , the lowest activity level was recorded during the weekend .


Patients with COPD could not perform any aerobic movement .


This study revealed a difference of physical activity in both healthy individuals and COPD patients , in the latter group the decrease being worse and in accordance with the disease severity .


The potential of secretory leukocyte protease inhibitor ( SLPI ) as a biomarker for colorectal cancer was studied .


A prospective , randomized , controlled , clinical trial was conducted in @ and @ to confirm whether the expression of SLPI correlates with prognosis and metastasis in colorectal cancer patients .


Immunohistochemistry was used to detect SLPI expression in colorectal cancer .


The expression of SLPI was scored by two pathologists independently .


Statistical analysis of the data was performed using a @ test to investigate the influence of SLPI on the pathologic characteristics of colorectal cancer .


Compared with normal tissue , SLPI was overexpressed in colorectal cancer tissue .


Overexpression of SLPI correlated with different grades ( moderate or good differentiation : @ % low expression versus @ % high expression , low differentiation : @ % low expression versus @ % high expression ) , TNM stage ( I or II : @ % low expression versus @ % high expression ; III or IV : @ % low expression versus @ % high expression ) , lymphatic metastasis ( @ % low expression versus @ % high expression ) and distal metastasis ( @ % low expression versus @ % high expression ) , but not with patient age or sex ( P = @ , P = @ ) .


Upregulated SLPI correlates with aggressive pathologic characteristics of colorectal cancer ; SLPI could be used as an indicator of progression and metastasis in patients with colorectal cancer .


The purpose of this study was to investigate the impact of recovery by cool or warm water immersion , between two @-m sprints on performance determinants and lactate responses in simulated competition conditions .


Eight well-trained sprint swimmers ( @ @ years ) , after an initial warm-up and @-minutes recovery with no immersion ( NI ) , performed a maximal @ m sprint .


A second @ m sprint followed after a second @-minute recovery period with passive immersion in either warm ( WI , @ C ) , or cool water ( CI , @ C ) .


In a crossover design , all subjects repeated the trial @ hours later utilizing the alternate immersion temperature .


During the @-m sprints , time and stroke characteristics were recorded .


Blood lactate and heart rates were measured before and after the trials .


Strength and flexibility were recorded before and after immersions and ratings of perceived exertion were evaluated .


There were no significant differences in time , event velocity , or stroke rate , between any of the trials .


With WI , a significant reduction of handgrip strength was observed ( P = @ ) with lower ratings of perceived exertion observed after the sprint .


Higher resting lactate levels were recorded , prior to swimming , after both the @-minute WI and CI water recoveries ( P < @ ) as compared to NI .


No correlation was observed between swim performance times and starting or peak lactate levels , with any type of recovery intervention ( R@ = @ ; slope NS from zero ) .


Recovery by cool ( @ C ) or warm ( @ C ) water immersion does not affect velocity or stroke characteristics in a @-m freestyle sprint , even when widely employed performance related determinants such as resting lactate levels and perceived exertion are not optimal .


Message framing outcomes of healthy behaviours as occurring ` every day ' vs. ` every year ' can influence the temporal proximity and perceived likelihood of these outcomes .


However , it is not known how pre-existing beliefs such as confidence in one 's ability to perform health-related behaviour interact with such messages .


The purpose of this research was to investigate whether eating self-efficacy moderates the effect of temporal framing ( day-frame vs. year-frame ) on snacking behaviour .


Participants ( N = @ ) completed the short form of the Weight Efficacy Lifestyle Questionnaire ( WEL-SF ) and read either a day-framed or year-framed message about the health benefits associated with avoiding snacking .


Consumption of snacks was reported @ days later .


For those with low levels of eating self-efficacy ( WEL-SF score < @ on a @-point response scale ) , the year-framed message was associated with lower levels of snacking than the day-framed message .


The current research identifies a key role for eating self-efficacy in shaping recipients ' responses to temporally framed messages about the health benefits associated with the avoidance of snacking .


Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis .


This phase @ study evaluated the safety and efficacy of luliconazole cream @ % in patients with tinea pedis .


A total of @ male and female patients aged @ years with tinea pedis and eligible for modified intent-to-treat analysis were randomized @:@ to receive luliconazole cream @ % ( n = @ ) or vehicle ( n = @ ) once daily for @ days .


Efficacy was evaluated at days @ and @ ( i.e. , days @ and @ posttreatment ) based on clinical signs ( erythema , scaling , pruritus ) and mycology ( KOH , fungal culture ) .


The primary outcome was complete clearance at day @ .


Safety evaluations included adverse events and laboratory assessments .


Complete clearance at day @ was achieved in @ % ( @/@ ) of patients treated with luliconazole cream @ % compared with @ % ( @/@ ) of patients treated with vehicle ( P < @ ) .


Similar safety profiles were obtained for luliconazole cream @ % and vehicle .


This study was conducted in a relatively small population under controlled clinical trial conditions .


Luliconazole cream @ % applied once daily for @ days is well tolerated and more effective than vehicle in patients with tinea pedis .


Small dense low density lipoprotein-cholesterol ( sdLDL-C ) molecules are more atherogenic compared with large buoyant ones .


Phytosterols-enriched diets are effective in decreasing total cholesterol ( TC ) and low density lipoprotein-cholesterol ( LDL-C ) concentrations in hyperlipidemic children without significant adverse effects .


Limited data on the impact of such a diet on sdLDL-C levels is available in adults while there are no reports concerning children .


The purpose of this study is to prospectively evaluate the effect of the daily consumption of @ g of plant sterols on sdLDL-C levels in children with hypercholesterolemia .


Fifty-nine children , @ with LDL-C @ mmol/l ( @ mg/dl ) and @ with LDL-C < @ mmol/l , aged @-@ @ years , were included in the study .


A yogurt-drink enriched with @ g of plant sterols was added to the daily diet of hypercholesterolemic children and @-@ months later lipid profiles were reassessed .


Direct quantitative methods were used to measure LDL-C and sdLDL-C levels .


The consumption of plant sterols reduced sdLDL-C significantly ( p < @ ) , but levels remained higher compared with controls ( p < @ ) .


TC , LDL-C , non high density lipoprotein-cholesterol ( NonHDL-C ) and apolipoprotein B ( ApoB ) levels also decreased significantly ( p < @ ) .


The median reduction of sdLDL-C and LDL-C was @ % and @ % , respectively .


These variables decreased > @ % in sixteen children ( @ % ) , independently from baseline levels , sex , age and body mass index ( BMI ) .


High density lipoprotein-cholesterol ( HDL-C ) , lipoprotein a -LSB- Lp ( a ) -RSB- , and triglycerides ( TGs ) levels remained unaffected .


Plant sterols decrease sdLDL-C significantly and may be beneficial for children with hypercholesterolemia .


Acute bowel toxicity significantly affects the quality of life of patients treated with pelvic radiotherapy .


This study was performed to assess whether pretreatment with famotidine can reduce acute radiation toxicities in patients undergoing radiotherapy for prostate cancer .


Between April @ and February @ , @ patients undergoing radiotherapy for prostate cancer were enrolled to receive either placebo or famotidine .


The patients received external-beam radiotherapy up to @ Gy at daily fractions of @-@ Gy ( @ days/week ) .


Oral famotidine @ mg ( @ mg/day ) or placebo was administered twice daily ( @ and @ h prior to each radiotherapy fraction ) .


Bowel and bladder acute toxicities were evaluated weekly during radiotherapy and once thereafter according to RTOG grading criteria .


Famotidine was well tolerated .


No grade III or higher acute toxicities were noted in the two groups .


Grade II rectal toxicity developed significantly more often in patients receiving placebo than in patients receiving famotidine ( @/@ vs. @/@ , p = @ ) .


Moreover , no rectal bleeding occurred in the famotidine group , while @ patients in the placebo group experienced rectal bleeding during treatment ( p = @ ) .


The duration of rectal toxicity in the radiotherapy course was also reduced in the famotidine group ( @ vs. @ days , p = @ ) .


No significant difference between the two groups was observed in terms of urinary toxicity .


We demonstrated for the first time that famotidine significantly reduces radiation-induced injury on rectal mucosa representing a suitable radioprotector for patients treated with radiotherapy for prostate cancer .


The aim of this study was to comparatively evaluate in vivo the disinfecting ability of conventional method and lasers in root canals .


Study criteria included @ single rooted teeth , which were indicated for root canal therapy followed to dental caries and trauma with intact crowns .


Such selected patients were randomly divided into @ groups , namely , Group A ( @ teeth ) and Group B ( @ teeth ) .


All clinical procedures were carried out under strict aseptic precautions .


The teeth in Group A were subjected to biomechanical preparation followed by the treatment with the help of diode laser containing the gallium aluminum and arsenic , which emitted @ nm wavelengths .


The teeth in Group B were treated with routine method of biomechanical preparation along with irrigation using sodium hypochlorite and hydrogen peroxide .


The microbiological samples were taken immediately after the access preparation and after the completion of the root canal disinfection and were sent for microbiological analysis .


The teeth in Group A showed presence of common strains of bacteria ranging from Streptococci , Staphylococci , Klebsiella , and Pseudomonas .


Reduction in the growth of microorganisms was found for all types of microorganisms .


Only @ samples exhibited the growth after treatment with laser .


Results of Group B also showed the presence of common strains of anaerobic and aerobic bacteria as shown in earlier studies , predominantly Staphylococcus , Streptococci , and Pseudomonas .


Statistical analysis showed non-significant P values for the microorganisms ; however , only @ samples showed the growth after treatment with conventional technique using sodium hypochlorite and hydrogen peroxide .


Conventional method by using sodium hypochlorite and hydrogen peroxide as irrigating solutions is highly effective in disinfecting the root canal .


Lasers when used can also reduce the bacterial load of the infected root canal .


Combination therapy with two or more different drugs , with the intension of reaching the same therapeutic goal , was heavily criticized for a long time .


However , it is accepted today , especially when advantage over monotherapy can be proved .


Our study was undertaken to compare whether propofol priming and midazolam predosing would affect total induction dose requirement of Propofol .


A prospective randomized , double blind control study was conducted where @ patients ( @-@ years ) were divided into @ groups .


Group P received @ mg/kg of Propofol , Group M received @ mg/kg of Midazolam and Group N received @ ml of Normal Saline @ minutes after intravenous pethidine @ mg / kg given for analgesia .


We compared the total dose of propofol requirement for induction of anaesthesia in all the @ groups , taking loss of verbal contact as the end point .


Additionally , changes in haemodynamic status like blood pressure and heart rate at various intervals were studied and compared among the groups .


The groups were similar in terms of age , sex , weight and American Society of Anesesthesiologists Physical Status.The dose of Propofol required to induce anesthesia in Midazolam group was @ mg/kg ,@ mg/kg in Propofol group and @ mg/kg in the control group .


There were less hemodynamic changes in Midazolam group compared to the other two .


Pre-dosing with Midazolam is more effective than Propofol priming in reducing the dose of Propofol induced anaesthesia associated with minimum hemodynamic alterations .


Most drug-eluting stents currently in use are coated with a polymer carrying the drug that is released for several weeks .


However , a durable polymer may provoke hypersensitive reaction , delayed artery healing , and eventually stent thrombosis .


The aim of this study was to investigate the safety and efficacy of a polymer-free paclitaxel-eluting stent ( PF-PES ) versus a polymer-based PES ( PB-PES ) .


Eligible patients undergoing percutaneous coronary intervention were randomized @:@ to receive either PF-PES or PB-PES .


The primary end point was late loss at @ months .


Intravascular ultrasound analysis at @ months and final @-year clinical follow-up were also performed .


From October @ to April @ , @ patients were enrolled and randomized into @ groups ( PF-PES : n = @ ; PB-PES : n = @ ) .


Mean in-stent lumen loss was @ @ mm for PF-PES and @ @ mm for PB-PES ( P < @ ) .


Mean neointimal area by intravascular ultrasound was higher in PF-PES than in PB-PES ( @ @ versus @ @ mm ( @ ) ; P < @ ) .


At @ years , a composite end point of all-cause death , any myocardial infarction , and target vessel revascularization occurred in @ % for PF-PES and @ % for PB-PES ( P = @ ) , mainly driven by a higher rate of target vessel revascularization ( PF-PES : @ % ; PB-PES : @ % ; P = @ ) .


One late stent thrombosis was observed in PF-PES .


Compared with PB-PES , PF-PES was associated with increased neointimal proliferation and subsequent clinical restenosis .


Polymer plays an essential role in the performance of drug-eluting stents .


Response to treatment may be useful for diagnostic confirmation of childhood tuberculosis ( TB ) .


We aimed to evaluate time to symptom resolution in children treated for pulmonary TB .


We compared pulmonary TB cases and noncases , classified by a published diagnostic algorithm , in South African children younger than @ .


TB treatment was prescribed independently on clinical grounds .


We analyzed independent determinants of baseline symptom resolution by Cox regression .


One hundred and ninety-one symptomatic children , median age @ months , were prescribed for TB treatment .


Chest radiograph features of TB were associated with longer time to resolution of cough ( adjusted hazard ratio , AHR @ ) , wheeze ( AHR @ ) and failure to thrive ( AHR @ ) , ( all P < @ ) .


However , median duration of baseline cough ( @ vs. @ days , P = @ ) , wheeze ( @ vs. @ days , P = @ ) and failure to thrive ( @ vs. @ days , P = @ ) did not differ in TB cases ( n = @ ) versus noncases ( n = @ ) .


Baseline symptoms take more than @ days to resolve in the majority of young children after starting TB treatment .


Furthermore , since time to resolution does not differentiate TB cases from noncases ; clinical response to treatment is not an appropriate diagnostic criterion for pediatric trials of TB diagnostics , drugs and vaccines .


This study sought to assess device-specific outcomes after implantation of bare-metal stents ( BMS ) , zotarolimus-eluting Endeavor Sprint stents ( ZES-S ) , paclitaxel-eluting stents ( PES ) , or everolimus-eluting stents ( EES ) ( Medtronic Cardiovascular , Santa Rosa , California ) in all-comer patients undergoing percutaneous coronary intervention .


Few studies have directly compared second-generation drug-eluting stents with each other or with BMS .


We randomized @,@ patients to BMS , ZES-S , PES , or EES implantation .


At @ days , each stent group received up to @ or @ months of clopidogrel therapy .


The key efficacy endpoint was the @-year major adverse cardiac event ( MACE ) including any death , myocardial infarction , or target vessel revascularization , whereas the cumulative rate of definite or probable stent thrombosis ( ST ) was the key safety endpoint .


Clinical follow-up at @ years was complete for @ % of patients .


The MACE rate was lowest in EES ( @ % ; @ % confidence interval -LSB- CI -RSB- : @ to @ ) , highest in BMS ( @ % ; @ % CI : @ to @ ) , and intermediate in PES ( @ % ; @ % CI : @ to @ ) and ZES-S ( @ % ; @ % CI : @ to @ ) groups ( chi-square test = @ , p = @ ) .


The @-year incidence of ST in the EES group ( @ % ; @ % CI : @ to @ ) was similar to that in the ZES-S group ( @ % ; @ % CI : @ to @ ) , whereas it was lower compared with the PES ( @ % , @ % CI : @ to @ ) and BMS ( @ % ; @ % CI : @ to @ ) groups ( chi-square = @ ; p = @ ) .


Our study shows that cumulative MACE rate , encompassing both safety and efficacy endpoints , was lowest for EES , highest for BMS , and intermediate for PES and ZES-S groups .


EES outperformed BMS also with respect to the safety endpoints with regard to definite or probable and definite , probable , or possible ST. ( PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia studY -LSB- PRODIGY -RSB- ; NCT@ ) .


To determine the efficacy of Rifaximin in prevention of repeated episodes of hepatic encephalopathy in patients with liver cirrhosis as compared to placebo .


Triple-blind , randomized placebo-controlled trial .


Department of Gastroenterology-Hepatology , Shaikh Zayed Hospital , Lahore , from October @ to April @ .


Patients in remission from recurrent hepatic encephalopathy resulting from cirrhosis were randomly assigned to receive either Rifaximin , at a dose of @ mg twice daily ( @ patients ) , or placebo ( @ patients . )


Patients were requested to take the drug orally twice daily for @ months or until they developed a breakthrough episode of hepatic encephalopathy .


Mean age of patients in treatment and control group was @ @ years and @ @ years respectively .


The most common etiology of cirrhosis was hepatitis C followed by hepatitis B. Patients who remained free of hepatic encephalopathy during study period were @ out of @ patients in control group and @ patients out of @ patients ( p = @ ) .


Most of the patients who developed breakthrough hepatic encephalopathy had a MELD score range of @-@ in both groups .


The number of deaths and adverse events was similar in both groups .


Over a @-month period , treatment with Rifaximin failed to maintain remission from hepatic encephalopathy more effectively than placebo in the studied group .


Novel sensory inputs for the control of food intake and gastrointestinal ( GI ) function are of increasing interest due to the rapid increase in nutrition-related diseases .


The essential amino acid L-lysine was demonstrated to have a selective impact on food intake , gastric emptying , and intestinal transit in rats , thus indicating a potential novel direct sensory input to assess dietary protein content and quality .


The aim of this study was to assess translational aspects of this finding and to investigate the dose-dependent effect of L-lysine on human and rat GI function .


L-lysine doses from @-@ mg in rats and @-@ @ g in humans were analyzed for their effect on gastric emptying and GI secretion .


Human GI function was assessed non-invasively using magnetic resonance imaging ( MRI ) , rat data were acquired using standard lethal measurement methods .


L-lysine dose dependently delayed gastric emptying and stimulated GI secretion in rats as reflected by residual phenol red content and increased gastric wet weight .


The dose-dependent delay in gastric emptying observed in rats was confirmed in humans with an increase in halftime of gastric emptying of @ min/g L-lysine , p < @ .


Moreover , a dose-dependent increase in intestinal fluid accumulation was observed ( @ mL/min/g L-lysine , p < @ ) .


No effect on alkaline tide , glucose concentration , hematocrit , or visceral sensations was detected .


This translational study demonstrates comparable dose-dependent effects of intragastric L-lysine on GI function in humans and rats and suggests a broader role for individual amino acids in the control of GI motility and secretion in vivo .


To assess and compare the effects of contact lens-based artificial pupil design and contralateral balanced multifocal contact lens combination ( CBMCLC ) on visual performance .


This randomized crossover study conducted at the University of Valencia , Spain included @ presbyopic patients using an artificial pupil contact lens in the nondominant eye and a CBMCLC .


After a month of lens wear , the binocular distance visual acuity ( BDVA ) , binocular near visual acuity ( BNVA ) , defocus curve , binocular distance , and near contrast sensitivity and near stereoacuity ( NSA ) were measured under photopic conditions ( @ cd/m@ ) .


Moreover , BDVA and binocular distance contrast sensitivity were examined under mesopic conditions ( @ cd/m@ ) .


Visual acuity at an intermediate distance and near vision was better with the CBMCLC than with the artificial pupil ( p < @ ) .


Statistically significant differences were found in contrast sensitivity between the two types of correction for distance ( under mesopic conditions ) and for near vision , with the CBMCLC exhibiting better results in both cases ( p < @ ) .


The mean NSA values obtained for the artificial pupil contact lens were significantly worse than those for the CBMCLC ( p = @ ) .


The CBMCLC provided greater visual performance in terms of intermediate and near vision compared with the artificial pupil contact lens .


To verify the clinical efficacy of acupuncture and moxibustion on depressive states of stroke patients ' spouses .


Forty-four subjects who were stroke patients ' spouses and according with inclusive criteria with mild or moderate depressive states were randomly divided into an acupuncture-moxibustion group and a blank control group , @ cases in each group .


In the acupuncture-moxibustion group , acupuncture was applied at Baihui ( GV @ ) , Shenting ( GV @ ) , Sishencong ( EX-HN @ ) , Hegu ( LI @ ) , Zusanli ( ST @ ) and Taichong ( LR @ ) , and suspended moxibustion was used at Shenque ( CV @ ) , Guanyuan ( CV @ ) and Zhongwan ( CV @ ) .


The treatment was given twice a week for continuous @ weeks .


In the blank control group , neither acupuncture nor moxibustion treatment was given , and the patients were only treated with health and psychological guidance .


Before treatment and after @-week treatment , scores of self-rating depression scale ( SDS ) and numbers of insomnia severity grade were observed .


In the two groups , the scores of SDS were both reduced than those before treatment ( both P < @ ) , and the decrease in the acupuncture-moxibustion group was more obvious ( P < @ ) .


After treatment , the number of insomnia severity grade in the acupuncture-moxibustion group was improved than that before treatment ( P < @ ) , and the improvement was evidently superior to that in the blank control group ( P < @ ) .


The numbers of insomnia severity grade of the blank control group before and after treatment had no statistic significance ( P > @ ) .


The acupuncture and moxibustion intervention plan has clinical treatment significance on the improvement of mild and moderate depressive states for the stroke patients ' primary caregivers who are the patients ' spouses .


Melasma has a negative impact on quality of life since it typically occurs on the face .


To evaluate the erythema and pigmentation of melasma lesions and the surrounding areas in patients receiving triple combination ( TC : hydroquinone , tretinoin , and fluocinolone acetonide ) regimens .


Patients first received an @-week daily TC treatment and were then randomized to twice weekly or tapering regimen with TC .


Melanin and erythema levels of lesions and surrounding areas were objectively measured using a narrowband reflectance spectrophotometer .


Progressive reduction in the mean melanin levels was observed in the treatment phase .


Following both maintenance regimens , there was no difference between melanin levels in the melasma lesions .


Adverse effects were rare in both phases of the study and there was borderline reduction in erythema with regimen II .


Both maintenance regimens were effective in maintaining results obtained during the initial treatment phase , and were safe and well-tolerated .


Erythema was less intense with the tapering regimen .


We compared the longer-term impact of the two most commonly applied forms of post-discharge management designed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure ( CHF ) .


We followed a multi-center randomized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for @ @ days .


Blinded endpoints included event-free survival from all-cause emergency hospitalization or death , all-cause mortality and rate of all-cause hospitalization and stay .


@ patients ( @ % male , aged @ @ years and @ % left ventricular systolic dysfunction ) were initially randomized to home-based ( n = @ ) or clinic-based ( n = @ ) intervention .


During extended follow-up ( complete for @ patients ) , @ all-cause hospitalizations ( @ days of hospital stay ) and @ ( @ % ) deaths occurred .


There was no difference in the primary endpoint ; @ ( @ % ) home-based versus @ ( @ % ) clinic-based patients remained event-free ( adjusted HR @ , @ % CI @ to @ ; p = @ ) .


Significantly fewer home-based ( @/@ , @ % ) than clinic-based intervention ( @/@ , @ % ) patients died ( adjusted HR @ , @ % CI @ to @ : p = @ ) .


Home-based versus clinic-based intervention patients accumulated @ and @ all-cause hospitalizations ( p = @ ) associated with @ ( median @ , IQR @ to @ ) versus @ ( @ , IQR @ to @ ) days of hospital stay ( p < @ for rate and duration of hospital stay ) .


Relative to clinic-based intervention , home-based intervention was not associated with prolonged event-free survival .


Home-based intervention was , however , associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term .


To investigate the contribution of Bispectralindex monitoring on the amount of used anaesthetic substance and the quality of anaesthesia in patients with persistent atrial fibrillation who would undergo cardioversion .


The prospective , randomised , controlled clinical study was conducted at Akdeniz University , Antalya , Turkey from October @ to November @ Sedation was performed on @ adult patients using midazolam and fentanyl .


Patients were randomised to group @ and @ .


In group @ cardioversion was performed when the BispectralIndex value was seen to have decreased to < @ and the Ramsay sedation score was @-@ .


In Group @ , BispectralIndex monitor was blinded to the investigator , and cardioversion was performed when Ramsay sedation score was @-@ .


In both groups , blood pressure , heart rate and Bispectral index values were recorded .


Total anaesthetic amount , awareness and pain were also assessed .


SPSS @ was used for statistical analysis .


Overall , @ ( @ % ) patients were male and @ ( @ % ) were female and there was no significant difference in the two groups in terms of age ( p > @ ) .


No statistically significant difference was detected between the groups in terms of induction time , anaesthetic need and Bispectral Index values ( p > @ ) .


In both groups , @ ( @ % ) patients perceived pain and @ ( @ % ) perceived the procedure .


In the presence of anaesthetist in the team , Bispectral Index monitoring did not contribute to the determining of anaesthetic drug dosage and the depth and quality of anaesthesia in patients with persistent atrial fibrillation during cardioversion .


To determine whether genotypes at @ major loci associated with late age-related macular degeneration ( AMD ) , complement factor H ( CFH ) and age-related maculopathy susceptibility @ ( ARMS@ ) , influence the relative benefits of Age-Related Eye Disease Study ( AREDS ) supplements .


Unplanned retrospective evaluation of a prospective , randomized , placebo-controlled clinical trial of vitamins and minerals for the treatment of AMD .


AREDS participants ( mean age , @ years ) who were at risk of developing late AMD and who were randomized to the @ arms of AREDS supplement treatment .


Analyses were performed using the Cox proportional hazards model to predict progression to late AMD ( neovascular or central geographic atrophy ) .


Statistical models , adjusted for age , gender , smoking status , and baseline AMD severity , were used to examine the influence of genotypes on the response to therapy with @ randomly assigned arms of AREDS supplement components : placebo , antioxidants ( vitamin C , vitamin E , - carotene ) , zinc , or a combination .


The influence of the genotype on the relative treatment response to the randomized components of the AREDS supplement , measured as progression to late AMD .


Of the @ genotyped AREDS participants of white ethnicity , late AMD developed in @ ( @ % ) during the mean follow-up of @ years .


As previously demonstrated , CFH genotype ( P = @ ) , ARMS@ ( P < @ ) , and supplement were associated individually with progression to late AMD .


An interaction analysis found no evidence that the relative benefits of AREDS supplementation varied by genotype .


Analysis of ( @ ) CFH rs@ and rs@ combined with ARMS@ rs@ with the @ randomly assigned arms of AREDS supplement and ( @ ) analysis of the combination of CFH rs@ and rs@ with ARMS@ c. @_@del@ins@ with the AREDS components resulted in no interaction ( P = @ and P = @ , respectively , before multiplicity adjustment ) .


The AREDS supplements reduced the rate of AMD progression across all genotype groups .


Furthermore , the genotypes at the CFH and ARMS@ loci did not statistically significantly alter the benefits of AREDS supplements .


Genetic testing remains a valuable research tool , but these analyses suggest it provides no benefits in managing nutritional supplementation for patients at risk of late AMD .


To analyze performance and fatigue effects of small-sided games ( SSG ) vs high-intensity interval training ( HIIT ) performed during a @-wk in-season period in high-level youth football .


Nineteen players from @ youth teams ( @ -LSB- SD @ -RSB- y , @ -LSB- @ -RSB- m , @ -LSB- @ -RSB- kg ) of the @ highest German divisions completed the study .


Teams were randomly assigned to @ of @ training sequences ( @ endurance sessions per wk ) : One training group started with SSG , whereas the other group conducted HIIT during the first half of the competitive season .


After the winter break , training programs were changed between groups .


Before and after the training periods the following tests were completed : the Recovery-Stress Questionnaire for Athletes , creatine kinase and urea concentrations , vertical-jump height ( countermovement jump -LSB- CMJ -RSB- , drop jump ) , straight sprint , agility , and an incremental field test to determine individual anaerobic threshold ( IAT ) .


Significant time effects were observed for IAT ( +@ % , ( p ) ( @ ) = @ ) , peak heart rate ( -@ % , ( p ) ( @ ) = @ ) , and CMJ ( -@ % , ( p ) ( @ ) = @ ) , with no significant interaction between groups ( P > @ ) .


Players with low baseline IAT values ( +@ % ) showed greater improvements than those with high initial values ( @ % ) .


A significant decrease was found for total recovery ( -@ % , ( p ) ( @ ) = @ ) , and an increase was found for urea concentration ( +@ % , ( p ) ( @ ) = @ ) .


Four weeks of in-season endurance training can lead to relevant improvements in endurance capacity .


The decreases in CMJ height and total-recovery score together with the increase in urea concentration might be interpreted as early signs of fatigue .


Thus , the danger of overtaxing players should be considered .


To evaluate the effects of whole body vibration ( WBV ) and local muscle vibration ( LMV ) on quadriceps function after experimental knee effusion ( ie , simulated pathology ) .


Randomized controlled trial .


Research laboratory .


Healthy volunteers ( N = @ ) were randomized to WBV ( n = @ ) , LMV ( n = @ ) , or control ( n = @ ) groups .


Saline was injected into the knee to induce quadriceps arthrogenic muscle inhibition ( AMI ) .


All groups then performed isometric squats while being exposed to WBV , LMV , or no vibration ( control ) .


Quadriceps function was assessed at baseline , immediately after effusion , and immediately and @ minutes after each intervention ( WBV , LMV , control ) via voluntary peak torque ( VPT ) and the central activation ratio ( CAR ) during maximal isometric knee extension on a multifunction dynamometer .


The CAR improved in the WBV ( @ % , P = @ ) and LMV ( @ % , P < @ ) groups immediately postintervention , but they did not improve in the control group .


Similarly , VPT increased by @ % ( P = @ ) in the WBV group and @ % ( P = @ ) in the LMV group immediately postintervention , but it did not increase in the control group .


The magnitudes of improvements in the CAR and VPT did not differ between the WBV and LMV groups .


Quadriceps AMI is a common complication following knee pathology that produces quadriceps dysfunction and increases the risk of posttraumatic osteoarthritis .


Quadriceps strengthening after knee pathology is often ineffective because of AMI .


WBV and LMV improve quadriceps function equivocally after simulated knee pathology , effectively minimizing quadriceps AMI .


Therefore , these stimuli may be used to enhance quadriceps strengthening , therefore improving the efficacy of rehabilitation and reducing the risk of osteoarthritis .


Cognitive behaviour therapy ( CBT ) is an effective treatment for depression .


However , CBT is a complex therapy that requires highly trained and qualified practitioners , and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand .


Behavioural activation ( BA ) is a psychological treatment for depression that may be an effective alternative to CBT and , because it is simpler , might also be delivered by less highly trained and specialised mental health workers .


COBRA is a two-arm , non-inferiority , patient-level randomised controlled trial , including clinical , economic , and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT .


Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care .


We will analyse for non-inferiority in per-protocol and intention-to-treat populations .


Our primary outcome will be severity of depression symptoms ( Patient Health Questionnaire-@ ) at @ months follow-up .


Secondary outcomes will be clinically significant change and severity of depression at @ months , and anxiety ( General Anxiety Disorder-@ questionnaire ) and health-related quality of life ( Short-Form Health Survey-@ ) at @ and @ months .


Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions , health and social care services used , plus productivity losses .