In the sham acupuncture group , the scores in @ h and @ h of acupuncture were reduced as compared with the previous one , indicating the significant difference ( all P < @ ) .


After acupuncture , VAS score at each time point in the acupuncture group was lower than that in the sham acupuncture group ( all P < @ ) .


The conventional acupuncture at Sanyinjiao ( SP @ ) achieves the significant analgesic effect on primary dysmenorrheal .


The psychological placebo effect of sham acupuncture has no obvious impact on acupuncture analgesia .


The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair ( PEVAR ) with use of a @F endovascular stent graft system and either an @ F or @ F suture-mediated closure system ( the PEVAR trial , NCT@ ) .


A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure .


Between @ and @ , @ U.S. institutions participated in a prospective , Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a `` preclose '' technique in conjunction with endovascular abdominal aortic aneurysm repair .


A total of @ patients were allocated by a @:@ design to percutaneous access/closure ( n = @ ) or open femoral exposure ( n = @ -LSB- FE -RSB- ) .


PEVAR procedures were performed with either the @ F Perclose ProGlide ( n = @ -LSB- PG -RSB- ) or the @ F Prostar XL ( n = @ -LSB- PS -RSB- ) closure devices .


All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix @ F profile ( outer diameter ) sheath-based system .


Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access .


The primary trial end point ( treatment success ) was defined as procedural technical success and absence of major adverse events and vascular complications at @ days .


An independent access closure substudy evaluated major access-related complications .


Clinical utility and procedural outcomes , ankle-brachial index , blood laboratory analyses , and quality of life were also evaluated with continuing follow-up to @ months .


Baseline characteristics were similar among groups .


Procedural technical success was @ % ( PG ) , @ % ( PS ) , and @ % ( FE ) .


One-month primary treatment success was @ % ( PG ) , @ % ( PS ) , and @ % ( FE ) , demonstrating noninferiority vs FE for PG ( P = @ ) but not for PS ( P = @ ) .


Failure rates in the access closure substudy analyses demonstrated noninferiority of PG ( @ % ; P = @ ) , but not of PS ( @ % ; P = @ ) , vs FE ( @ % ) .


Compared with FE , PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss , groin pain , and overall quality of life .


Initial noninferiority test results persist to @ months , and no aneurysm rupture , conversion to open repair , device migration , or stent graft occlusion occurred .


Among trained operators , PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective , with minimal access-related complications , and it is noninferior to standard open femoral exposure .


Training , experience , and careful application of the preclose technique are of paramount importance in ensuring successful , sustainable outcomes .


The aim of this study was to investigate the efficacy of bladder training before removing the indwelling urinary catheter in patients with acute urinary retention ( AUR ) associated with benign prostatic hyperplasia ( BPH ) .


In total , @ consecutive patients with their first episode of spontaneous AUR associated with BPH were enrolled in this prospective randomized controlled trial .


They were randomly assigned to be given either pharmacological treatment combined with bladder training or pharmacological treatment ( tamsulosin @ mg and finasteride @ mg once daily ) with free drainage of urinary catheter for @ days , and a trial without catheter ( TWOC ) was performed .


Data on patients ' baseline demographics , history of BPH , International Prostate Symptom Score , prostate size , serum prostate-specific antigen , intravesical prostatic protrusion , TWOC success rates and related complications were collected and statistically analysed .


The two groups of spontaneous AUR patients with BPH were given pharmacological treatment combined with bladder training before catheter removal ( n = @ ) or pharmacological treatment alone ( n = @ ) for @ days .


All @ patients underwent a first TWOC with an overall success rate of @ % after first @ days ' catheterization ; TWOC was successful in @ % of cases in the intervention group and @ % in the control group .


There was no statistically significant difference in TWOC success rate between the two groups ( p > @ ) .


This randomized controlled trial showed that bladder training before urinary catheter removal did not increase the chance of TWOC success significantly in spontaneous AUR patients with BPH .


Abstinence from chronic cocaine use is associated with abnormal sleep architecture .


As sleep abnormalities are associated with clinical outcome in alcohol dependence , we hypothesized a similar relationship in cocaine dependence .


We report data from a cocaine self-administration study ( N = @ ) and the placebo arm of a randomized clinical trial ( N = @ ) .


Self-administration participants underwent three cocaine self-administration sessions during a three-week inpatient stay .


Treatment participants underwent two weeks of inpatient followed by six weeks of outpatient treatment including once-weekly cognitive behavioral therapy .


Measurements included polysomnography from early and late in abstinence during the inpatient stays .


Clinical outcomes included amount of cocaine self-administered , urine tests , and self-reported use and withdrawal symptoms .


Change in slow-wave sleep from early to late abstinence ( SWS ; p = @ ) , late abstinence rapid eye movement sleep ( REM ; p = @ ) , and late abstinence total sleep time ( p = @ ) were negatively correlated with the amount of cocaine self-administered .


Early abstinence REM was positively correlated with withdrawal symptoms ( p = @ ) .


Late abstinence REM was positively correlated with percent negative urines and maximum consecutive number of days abstinent ( both p < @ ) .


SWS was positively correlated with percent negative urines ( p = @ ) and participants with increased SWS had greater percent negative urines ( p = @ ) and maximum consecutive number of days abstinent ( p = @ ) .


Correlations between sleep deficits and amount of cocaine self-administered , clinical outcomes , and severity of withdrawal symptoms underscore the relevance of sleep in clinical outcomes in the treatment of cocaine dependence .


Randomized trial with a concurrent observational cohort study .


To compare @-year outcomes of surgery with nonoperative care for symptomatic lumbar spinal stenosis .


Surgery for spinal stenosis has been shown to be more effective than nonoperative treatment during @ years , but longer-term data are less clear .


Surgical candidates from @ centers in @ US states with at least @ weeks of symptoms and confirmatory imaging were enrolled in a randomized cohort or observational cohort .


Treatment was standard , decompressive laminectomy versus standard nonoperative care .


Primary outcomes were SF-@ ( MOS @-Item Short-Form Health Survey ) Bodily Pain and Physical Function scales and the modified Oswestry Disability Index assessed at @ weeks , @ months , @ months , and yearly up to @ years .


Data were obtained for @ % of participants in the randomized group and @ % of participants in the observational group at the @-year follow-up .


Intent-to-treat analyses showed no differences between randomized cohorts ; however , @ % of those randomized to surgery and @ % of those randomized to nonoperative had undergone surgery by @ years .


As-treated analyses in the randomized group showed that the early benefit for surgery out to @ years converged over time , with no significant treatment effect of surgery seen in years @ to @ for any of the primary outcomes .


In contrast , the observational group showed a stable advantage for surgery in all outcomes between years @ and @ .


Patients who were lost to follow-up were older , less well-educated , sicker , and had worse outcomes during the first @ years in both surgical and nonoperative arms .


Patients with symptomatic spinal stenosis show diminishing benefits of surgery in as-treated analyses of the randomized group between @ and @ years , whereas outcomes in the observational group remained stable .


Loss to follow-up of patients with worse early outcomes in both treatment groups could lead to overestimates of long-term outcomes but likely not bias treatment effect estimates .


Controlled , repeated-measures , single-blind randomized study .


To determine the effect of cervical or thoracic manipulation on neurotensin , oxytocin , orexin A , and cortisol levels .


Previous studies have researched the effect of spinal manipulation on pain modulation and/or range of movement .


However , there is little knowledge of the biochemical process that supports the antinociceptive effect of spinal manipulation .


Thirty asymptomatic subjects were randomly divided into @ groups : cervical manipulation ( n = @ ) , thoracic manipulation ( n = @ ) , and nonmanipulation ( control ) ( n = @ ) .


Blood samples were extracted before , immediately after , and @ hours after each intervention .


Neurotensin , oxytocin , and orexin A were determined in plasma using enzyme-linked immuno assay .


Cortisol was measured by microparticulate enzyme immuno assay in serum samples .


Immediately after the intervention , significantly higher values of neurotensin ( P < @ ) and oxytocin ( P < @ ) levels were observed with both cervical and thoracic manipulation , whereas cortisol concentration was increased only in the cervical manipulation group ( P < @ ) .


No changes were detected for orexin A levels .


Two hours after the intervention , no significant differences were observed in between-group analysis .


The mechanical stimulus provided by spinal manipulation triggers an increase in neurotensin , oxytocin , and cortisol blood levels .


Data suggest that the initial capability of the tissues to tolerate mechanical deformation affects the capacity of these tissues to produce an induction of neuropeptide expression .


To identify the risk-predictive baseline profile patterns of demographic , genetic , immunologic , and metabolic markers and synthesize these patterns for risk prediction .


RuleFit is used to identify the risk-predictive baseline profile patterns of demographic , immunologic , and metabolic markers , using @ subjects who were randomized into the control arm of the prospective Diabetes Prevention Trial-Type @ ( DPT-@ ) study .


A novel latent trait model is developed to synthesize these baseline profile patterns for disease risk prediction .


The primary outcome was Type @ Diabetes ( T@D ) onset .


We identified ten baseline profile patterns that were significantly predictive to the disease onset .


Using these ten baseline profile patterns , a risk prediction model was built based on the latent trait model , which produced superior prediction performance over existing risk score models for T@D .


Our results demonstrated that the underlying disease progression process of T@D can be detected through some risk-predictive patterns of demographic , immunologic , and metabolic markers .


A synthesis of these patterns provided accurate prediction of disease onset , leading to more cost-effective design of prevention trials of T@D in the future .


Vitamin D is a potent immunomodulator , but its impact on morbidity and mortality among infants remains unclear .


The objective of the study was to prospectively assess the association of vitamin D status with mortality , morbidity , and growth during the first @ y of life .


A prospective cohort of @ HIV-infected and @ HIV-exposed Tanzanian infants enrolled in a randomized trial of multivitamins ( not including vitamin D ) was studied .


Serum @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- concentrations were measured at @-@ wk of age and infants were followed at monthly clinic visits until @ mo. .


Physicians performed a clinical exam every @ mo or when an illness was noted .


Serum @ ( OH ) D concentrations were ( means SDs ) @ @ ng/mL and @ @ ng/mL for HIV-infected and HIV-exposed infants , respectively .


Unexpectedly , serum @ ( OH ) D concentrations @ ng/mL were significantly associated with higher mortality as compared to the @-@ @ ng/mL reference for HIV-infected ( HR : @ ; @ % CI : @ , @ ; P = @ ) and HIV-exposed ( HR : @ ; @ % CI : @ , @ ; P < @ ) infants after multivariate adjustment .


We found no statistically significant association between @ ( OH ) D concentrations < @ ng/mL and mortality for HIV-infected ( HR : @ ; @ % CI : @ , @ ; P = @ ) and HIV-exposed ( HR : @ ; @ % CI : @ , @ ; P = @ ) infants .


Among HIV-exposed infants , @ ( OH ) D concentrations @ ng/mL were significantly associated with clinical -LSB- incidence ratio rate ( IRR ) : @ ; @ % CI : @,@ ; P = @ -RSB- and confirmed ( IRR : @ ; @ % CI : @ ; @ , @ ; P < @ ) malaria diagnoses , whereas concentrations of < @ ng/mL were associated with oral candidiasis ( IRR : @ ; @ % CI : @-@ @ ; P = @ ) and wasting ( HR : @ ; @ % CI : @ , @ ; P < @ ) .


The observational design of this study does not allow for causal interpretation ; however , the results indicate a strong need for additional studies of vitamin D among HIV-infected and - exposed children , particularly in malaria-endemic settings .


The parent trial was registered at clinicaltrials.gov as NCT@ .


Benzodiazepines , other anxiolytics , or sedative hypnotics are prescribed for @ % -@ % of posttraumatic stress disorder ( PTSD ) patients .


Prior data and theory suggest that these medications may inhibit response to exposure therapy , one of the most effective PTSD treatments .


The present post hoc study reanalyzed results from a psychotherapy trial to assess whether benzodiazepine use was associated with reduced response to exposure therapy .


Between August @ and October @ , @ female veterans and soldiers meeting DSM-IV criteria for PTSD were randomly assigned to @ weekly @-minute sessions of either prolonged exposure ( n = @ ) or present-centered psychotherapy ( n = @ ) .


Benzodiazepine use ( n = @ ) or non-use ( n = @ ) at intake was not randomly assigned .


Multilevel modeling was used to assess the effects of benzodiazepine status , psychotherapy condition , and their interaction on changes on the Clinician-Administered PTSD Scale and the PTSD Checklist during the treatment and @-month follow-up periods .


Consistent with prior reports from these data , prolonged exposure psychotherapy produced greater reductions per week in PTSD symptoms than did present-centered psychotherapy ( b = -@ , P = @ ) .


Patients prescribed benzodiazepines did not have weaker response to prolonged exposure , but demonstrated poorer posttreatment maintenance of gains from present-centered psychotherapy ( b = -@ , P < @ ) .


Prolonged exposure is a sufficiently robust treatment that patients who are taking benzodiazepines can benefit from it .


It is unclear whether benzodiazepine use or other patient factors accounted for benzodiazepine recipients ' poorer maintenance of gains in present-centered psychotherapy .


The effects of hypoxic training on exercise performance remain controversial .


Here , we tested the hypotheses that i ) hypoxic training possesses ergogenic effects at sea level and altitude and ii ) the benefits are primarily mediated by improved mitochondrial function of the skeletal muscle .


We determined aerobic performance ( incremental test to exhaustion and time trial for a set amount of work ) in moderately trained subjects undergoing @ wk of endurance training ( @-@ times per week , @ min per session ) in normoxia ( placebo , n = @ ) or normobaric hypoxia ( FIO@ = @ , n = @ ) using a double-blind and randomized design .


Exercise tests were performed in normoxia and acute hypoxia ( FIO@ = @ ) .


Skeletal muscle mitochondrial respiratory capacities and electron coupling efficiencies were measured via high-resolution respirometry .


Total hemoglobin mass was assessed by carbon monoxide rebreathing .


Skeletal muscle respiratory capacity was not altered by training or hypoxia ; however , electron coupling control respective to fat oxidation slightly diminished with hypoxic training .


Hypoxic training did increase total hemoglobin mass more than the placebo ( @ % vs @ % , P = @ ) .


In normoxia , hypoxic training had no additive effect on maximal measures of oxygen uptake or time trial performance .


In acute hypoxia , hypoxic training conferred no advantage on maximal oxygen uptake but tended to enhance time trial performance more than normoxic training ( @ % vs @ % , P = @ ) .


Our data suggest that , in moderately trained subjects , @ wk of hypoxic training possesses no ergogenic effect at sea level .


It is not excluded that hypoxic training might facilitate endurance capacity at moderate altitude ; however , this issue is still open and needs to be further examined .


In this randomized trial , Project CARE , we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors .


Both complementary medicine interventions were @-sessions , manualized , group-based , and were culturally adapted for black women in the community from evidence-based interventions .


Participants were @ black women ( mean age = @ , @-@ years ) who had completed breast cancer treatment @-@ months before enrollment ( stages @-IV , mean time since cancer diagnosis = @ months ) .


Women were enrolled upon completion of curative treatment ( ie , surgical , chemotherapy , radiation oncology ) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program .


There was a remarkable @ % retention rate from baseline to @-month follow-up .


Participants in both conditions showed statistically significant improvement on indices of psychological well-being , including overall quality of life ( Functional Assessment of Cancer Therapy-Breast ) , intrusive thoughts ( Impact of Event Scale-Revised ) , depressive symptoms ( Center for Epidemiologic Studies-Depression ) , and stress levels ( Perceived Stress Scale ) over the @-month postintervention follow-up ( all repeated measures analysis of variance within-subjects time effects : P < @ , except for overall mood ; Profile of Mood States-Short Version ) .


Contrary to hypotheses , however , condition time effects were not statistically significant .


Findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management , extensive provision of breast cancer information , or participation in an ongoing supportive group of individuals from a similar racial background .


Implications bear on decisions about appropriate control groups , the timing of intervention delivery during the treatment trajectory , and perceived support from the research team .


The treatment of acne can be difficult , with suboptimal adherence resulting in poor treatment outcomes .


To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence .


Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks .


Subjects were randomized into sample or no sample group .


Sample group received a demonstration on how to apply the medication using a product sample .


The primary outcome was median adherence , recorded using electronic monitoring , and secondary outcomes were efficacy measures including the Acne Global Assessment ( AGA ) and lesion counts and the Perceived Medical Condition Self-Management Scale ( PMCSMS ) .


Data from @ patients was collected and analyzed .


Median adherence rates were @ % in the sample group and @ % in the no sample group ( p = @ ) .


The median percent improvement in non-inflammatory lesions were @ % for the sample group and @ % for the no-sample group ( p = @ ) .


The small size of this pilot study limited the extent of subgroup analyses .


Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne .


There is a considerable potential effect size on adherence for the use of samples , supporting the need for future , well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases .


High blood pressure ( BP ) is commonly not diagnosed , and patients do not achieve target values when treated .


Among @,@ patients encompassing most races-ethnicities , we evaluated BP measurements and treatment response in a stroke prevention trial .


Our goal was to identify BP measurement differences between clinical trial and patient determinations and among the racial-ethnic groups .


A total of @,@ patients with ischemic stroke were randomized to receive antiplatelet treatment and @ mg of telmisartan versus placebo .


BP measurements were obtained at the first clinic visit and then @ and @ months later and every @ months thereafter .


One week after the first clinic visit , patients were requested to report a BP measurement obtained elsewhere .


Measurements at the trial clinics were obtained with the same electronic device .


Statistical analysis was used to detect significant differences .


The mean patient age was @ years ; @ % were women , and race-ethnicity comprised @ % Whites , @ % Asian , @ % Hispanic , and @ % Black .


Overall , @ % of patients were hypertensive .


BP varied between the race-ethnicity groups , being highest in Hispanics ( @/@ ) and lowest in Blacks ( @/@ ) .


BP at visits clinic @ , nonclinic @A , and clinic @ were , respectively , @/@ , @/@ , and @/@ mmHg , with the difference between visits @-@ and visit @A being significant .


BPs were normal in @ % of the cases at visit @A , and of these , only @ % were normal at visit @ and @ % were normal on visit @ .


Similar findings were noted for all race-ethnicity groups .


BP values varied among race-ethnicities and showed differences between clinic and patient measurements .


This finding questions the reliability of self-reported BP and has implications for BP management in daily clinical practice .


To assess the incremental cost and cost-effectiveness of continuous and discontinuous regimens of bevacizumab ( Avastin ) and ranibizumab ( Lucentis ) for neovascular age-related macular degeneration ( nAMD ) from a UK National Health Service ( NHS ) perspective .


A within-trial cost-utility analysis with a @-year time horizon , based on a multicentre factorial , non-inferiority randomised controlled trial .


@ hospital ophthalmology clinics .


@ patients aged @years with untreated nAMD in the study eye .


@ mg ranibizumab or @ mg bevacizumab given continuously ( monthly ) or discontinuously ( as-needed ) for @years .


Quality-adjusted life-years ( QALYs ) .


Total @-year costs ranged from @/patient ( $ @ ; @ % CI @ to @ ) for discontinuous bevacizumab to @/patient ( $ @ ; @ % CI @ to @ ) for continuous ranibizumab .


Ranibizumab was significantly more costly than bevacizumab for both continuous ( +@ / patient ( $ @ ) ; @ % CI @ to @ ; p < @ ) and discontinuous treatment ( +@ ( $ @ ) ; @ % CI @ to @ ; p < @ ) , with negligible difference in QALYs .


Continuous ranibizumab would only be cost-effective compared with continuous bevacizumab if the NHS were willing to pay @ million ( $ @ million ) per additional QALY gained .


Patients receiving continuous bevacizumab accrued higher total costs ( +@ ( $ @ ) ; @ % CI @ to @ ; p = @ ) than those receiving discontinuous bevacizumab , but also accrued non-significantly more QALYs ( +@ ; @ % CI -@ to @ ; p = @ ) .


Continuous bevacizumab therefore cost @ ( $ @ ) per QALY gained versus discontinuous bevacizumab .


However , bootstrapping demonstrated that if the NHS is willing to pay @/QALY gained , there is a @ % chance that continuous bevacizumab is cost-effective versus discontinuous bevacizumab .


Ranibizumab is not cost-effective compared with bevacizumab , being substantially more costly and producing little or no QALY gain .


Discontinuous bevacizumab is likely to be the most cost-effective of the four treatment strategies evaluated in this UK trial , although there is a @ % chance that continuous bevacizumab is cost-effective .


To evaluate two low-dose volumes ( @ mL or @ mL ) of @ % mepivacaine solution used for ultrasound-guided axillary blockade for outpatients undergoing distal upper limb surgery .


Prospective , double-blinded randomized study .


Outpatient surgical setting of a university-affiliated hospital .


@ adult , ASA physical status @ , @ , and @ patients , aged @-@ years , scheduled for upper limb surgery .


Patients were randomized to two groups to receive either @ mL of @ % mepivacaine solution ( n = @ ) or @ mL of @ % mepivacaine solution ( n = @ ) for ultrasound-guided axillary plexus blockade .


Block duration , proportion of surgical and functional successful blocks , onset of sensory and motor blockade measured from @ to @ minutes following final needle extraction , total amount of preoperative sedative ( midazolam ) , and intraoperative propofol administered were recorded .


Following axillary plexus blockade , neither patient group showed any statistically significant difference in the percentage of functionally successful blockade ( @ mL , @ % : @ mL , @ % ; P = @ ) , surgically successful blockade ( @ mL , @ % ; @ mL , @ % ; P = @ ) , cumulative sensory or motor blockade surgical time , block performance time , preoperative midazolam use , or intraoperative propofol use .


Low volumes ( @ mL or @ mL ) of @ % mepivacaine provides satisfactory anesthesia for ambulatory distal upper limb surgery with no significant difference in clinical outcomes .


To assess the effect of dimeticone and pepsin on the bioavailability of metoclopramide ( CAS @-@-@ ) in healthy volunteers .


The study was conducted using a randomized , open , @-period crossover design .


The volunteers received single administration of @-mg conventional metoclopramide capsule and a formulation containing metoclopramide ( @mg ) plus dimeticone ( @mg ) and pepsin ( @mg ) , with a @-day interval between treatments .


Serial blood samples were collected before dosing and during @h post-treatment .


Plasma metoclopramide concentrations were analyzed by liquid chromatography coupled with tandem mass spectrometry ( LC-MS/MS ) .


The pharmacokinetics parameters AUC ( last ) and C ( max ) were obtained from the metoclopramide plasma concentration vs. time curves .


Metoclopramide 's association was bioequivalent to conventional capsule ; @ % CIs for geometric mean treatment ratios of C ( max ) -LSB- @ % ( @ % CI , @-@ @ % ) -RSB- , AUC ( last ) -LSB- @ % ( @ % CI , @-@ @ % ) -RSB- were within the predefined range .


The metoclopramide formulations were well tolerated at the administered doses and no significant adverse reactions were observed .


Thus , these results confirm the good bioavailability of metoclopramide in the new formulation and rule out any impaired absorption when the drugs are formulated in combination .


Esophageal variceal bleed is a major problem in patients with cirrhosis .


Endoscopic variceal ligation ( EVL ) has been shown to be equal to or better than propranolol in preventing first bleed .


Carvedilol is a non-selective blocker with alpha-@ adrenergic blocker activity .


Hemodynamic studies have shown carvedilol to be more effective than propranolol at reducing portal pressure .


We compared efficacy of carvedilol with EVL for primary prophylaxis of esophageal variceal bleed .


Cirrhotic patients with esophageal varices were randomized to carvedilol @ mg daily or EVL at three university hospitals of Pakistan .


End points were esophageal variceal bleeding , death or liver transplant .


Two hundred and nine patients were evaluated .


Eighty two and eighty six patients were randomized in carvedilol and EVL arms respectively .


Mean age was @ @ years ; @ ( @ % ) were males ; @ % had viral cirrhosis ; mean Child-Pugh score was @ @ and mean follow up was @ @ months ( range @-@ months ) .


Both EVL and carvedilol groups had comparable variceal bleeding rates ( @ % vs. @ % ) , bleed related mortality ( @ % vs. @ % ) and overall mortality ( @ % vs. @ % ) respectively .


Adverse events in carvedilol group were hypotension ( n = @ ) , requiring cessation of therapy , while transient nausea ( n = @ ) and dyspnea ( n = @ ) resolved spontaneously .


In the EVL arm , post banding ulcer bleed ( n = @ ) and chest pain ( n = @ ) , were termed as serious adverse events while transient dysphagia ( n = @ ) resolved without treatment .


Although our study is underpowered , the findings suggest that carvedilol is probably not superior to EVL in preventing first variceal bleed in patients with viral cirrhosis .


The aim of this study is to systematically investigate under standardized experimental conditions the effects of instrument contamination and wear on the quality of bipolar vessel sealing ( BVS ) achieved using a reusable instrument .


The study was designed as a prospective , randomized , and controlled in vitro study and conducted in an academic research environment .


Reusable bipolar coagulation forceps ( BiClamp @ C , ERBE Elektromedizin ) were used to apply sealing pressures of @-@ ,@ mN/mm ( @ ) to @ renal arteries from commercially slaughtered female pigs ( Swabian-Hall Swine ) .


Forceps jaws were coated with porcine blood , blood and collagen , or blood , collagen , and fat to simulate instrument contamination with biological material during surgery .


Clinical wear was mimicked by sandpaper abrasion .


The main outcome measures were seal success ( resistance to @ mmHg intraluminal pressure for @ min ) and seal stability ( burst pressure ) .


Sealing pressure had a significant impact , with @ mN/mm ( @ ) producing the best sealing results .


Seal success increased with total energy applied to the tissue , a higher maximum temperature , and longer coagulation as indicated by desiccation time .


Experimental contamination had no significant impact on seal success and only a limited effect on seal stability .


Similarly , abrasive wear also had no significant effect on either seal quality or seal strength .


The impact of bipolar forceps contamination and wear on seal success and quality was negligible in our in vitro model .


To achieve high-quality seals , it is essential to use adequate sealing pressures .


Our findings could have direct implications for the design and clinical handling of BVS instruments .


Antispasmodic agents have been used in the management of irritable bowel syndrome .


However , systematic reviews have come to different conclusions about the efficacy in irritable bowel syndrome .


Fenoverine acts as a synchronizer of smooth muscle in modulating the intracellular influx of calcium .


We compared fenoverine with trimebutine for the treatment of patients with IBS .


A multicenter , randomized , double-blind , non-inferiority clinical study was conducted to compared fenoverine with trimebutine .


Subjects were randomized to receive either fenoverine ( @ mg three times a day ) or trimebutine ( @ mg three times a day ) for @ weeks .


A total of @ patients were analyzed by the intention-to-treat approach .


The primary endpoint was the proportion of patients who had @ % reduction in abdominal pain or discomfort measured by bowel symptom scale ( BSS ) score at week @ compared to the baseline .


The secondary endpoints were changes of abdominal bloating , diarrhea , constipation , overall and total scores of BSS , and overall satisfaction .


At week @ , fenoverine was shown to be non-inferior to trimebutine ( treatment difference , @ % ; @ % CI , -@ -@ ; p = @ ) ; @ % ( @ of @ patients ) of patients taking fenoverine and @ % ( @ of @ patients ) of patients taking trimebutine showed @ % reduction in abdominal pain or discomfort compared to the baseline .


There results of the secondary endpoints were also comparable between the fenoverine group and the trimebutine group .


Fenoverine is non-inferior to trimebutine for treating IBS in terms of both efficacy and tolerability .


To evaluate , by means of a prospective randomized study , the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant .


Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism ( @ hypercalcemics and @ normocalcemics ) , equally divided between males and females , were randomly but not blindly addressed to treatment with potassium citrate and allopurinol , or to the same therapeutic regimen in combination with cinacalcet .


The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone ( PTH ) within normal limits while enabling the maintenance of adequate calcemic values .


All study participants were given the same diet based on a reduction in sodium intake , oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration .


After a follow up period of @ months , cinacalcet was associated to standard therapy and diet in patients who were not taken it , conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet .


Follow up was continued for a second period of observation of the same duration of the first .


At the end of the period of treatment with cinacalcet , for both variants of hyperparathyroidism , a statistically significant reduction in the overall number and in the diameter of renal stones was found .


This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake , in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism .


Levomilnacipran extended-release ( ER ) is an FDA-approved serotonin norepinephrine reuptake inhibitor ( SNRI ) for treating major depressive disorder ( MDD ) .


SF-@v@ Health Survey outcomes from a Phase III , randomized , double-blind , placebo-controlled study ( NCT@ ) were evaluated .


Prospective and post hoc analyses of SF-@ Mental and Physical Component Summaries ( MCS , PCS ) , and individual domains compared pooled levomilnacipran ER doses ( @ , @ , @ mg/day ) with placebo .


Patients ( @-@ years ) had MDD , depressive episode @ weeks , and Montgomery-sberg Depression Rating Scale total score @ .


SF-@ score changes from baseline to Week @ were analyzed using ANCOVA and the observed cases approach ( Intent-to-Treat -LSB- ITT -RSB- Population ) .


Minimally important differences ( MID ) evaluated clinical relevance .


Baseline MCS scores reflected marked mental deficits in the ITT Population ( levomilnacipran ER = @ ; placebo = @ ) .


MCS change at Week @ was significantly greater for levomilnacipran ER than placebo ( LSMD -LSB- SE -RSB- = @ -LSB- @ -RSB- ; P = @ ) ; MID exceeded the @-point threshold .


Baseline PCS scores suggested minimal physical deficits ; no between-group difference at Week @ was noted .


LSMD was nominally statistically significant ( P < @ ) for levomilnacipran ER versus placebo in @ domains ( General Health -LSB- @ ; P = @ -RSB- , Vitality -LSB- @ ; P = @ -RSB- , Social Functioning -LSB- @ ; P = @ -RSB- , Role-Emotional -LSB- @ ; P = @ -RSB- , Mental Health -LSB- @ ; P = @ -RSB- ) ; changes in Vitality , Social Functioning , and Mental Health exceeded MID .


The trial was limited by short duration ; analyses were post hoc and adjustments were not made for multiplicity .


Statistically significant and clinically meaningful improvement on the MCS and several individual domains suggest overall and dimensional improvement in health-related functioning for patients with MDD treated with levomilnacipran ER versus placebo .


To compare best-corrected visual acuity ( BCVA ) and central macular thickness ( CMT ) after @-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation for the treatment of diabetic macular oedema ( DME ) .


Twenty-three patients ( @ eyes ) with binocular DME were enroled in this study .


The two eyes of each patient were divided into a subthreshold photocoagulation group and a threshold photocoagulation group .


The eyes of the subthreshold group underwent @-nm patter scan laser system ( PASCAL ) @ % end point subthreshold laser grid photocoagulation therapy , whereas the threshold photocoagulation group underwent short-pulse grid photocoagulation with a @-nm PASCAL system .


BCVA and CMT were assessed in all patients before treatment , @ days after treatment , and @ , @ , and @ months after treatment .


After grid photocoagulation , the mean BCVA improved in both the subthreshold group , and the threshold group , and the two groups did not differ statistically significantly from each other .


Similarly , the macular oedema diminished in both groups after treatment , and the two groups did not differ statistically significantly from each other with regard to CMT .


Both @-nm subthreshold laser grid photocoagulation and threshold laser grid photocoagulation can improve the visual acuity and reduce CMT in DME patients .


The purpose of this study was to investigate the effects of massage therapy compared with occlusal splint therapy on mandibular range of motion ( ROM ) in individuals with temporomandibular disorder ( TMD ) and compare the results with ROM obtained in a group of individuals without this disorder .


A blinded randomized clinical trial was conducted .


Twenty-eight volunteers with TMD were randomly distributed into either a massage therapy group or an occlusal splint group .


Both treatments were provided for @ weeks .


Fourteen individuals without TMD were consecutively allocated to a comparison group .


Fonseca anamnestic index was used to characterize TMD and allocate the volunteers to either of the intervention groups or asymptomatic comparison group .


Mandibular ROM was evaluated before and after treatment using a digital caliper .


Two-way repeated-measures analysis of variance with a post hoc Bonferroni testing was used for intergroup and intragroup comparisons ( level of significance was set to @ % ) .


Cohen d was used to calculate the effect size .


In the intragroup analysis , significant increases in ROM were found for all measures in both the massage and occlusal splint groups ( P < @ ) .


A small to moderate clinical effect of treatment with the occlusal splint was found regarding right and left lateral excursion in comparison with the massage therapy and asymptomatic comparison groups ( @ < d < @ ) .


Massage therapy on the masticatory muscles and the use of an occlusal splint lead to an increase in mandibular ROM similar to that of the asymptomatic comparison group with regard to maximum active mouth opening and both right and left excursion in individuals with TMD .


Evidence exists for the effectiveness of cognitive behaviour therapy for psychosis with moderate effect sizes , but the evidence for cognitive behaviour therapy specifically for distressing voices is less convincing .


An alternative symptom-based approach may be warranted and a body of literature has explored distressing voices from an interpersonal perspective .


This literature has informed the development of relating therapy and findings from a case series suggested that this intervention was acceptable to hearers and therapists .


An external pilot randomized controlled trial ( RCT ) comparing outcomes for @ patients receiving @hours ( weekly sessions of one hour ) of relating therapy and their usual treatment with @ patients receiving only their usual treatment .


Participants will be assessed using questionnaires at baseline , @weeks ( post-intervention ) , and @weeks ( follow-up ) .


Expected outcomes will include a refined study protocol and an estimate of the effect size to inform the sample size of a definitive RCT .


If evidence from a fully powered RCT suggests that relating therapy is effective , the therapy will extend the range of evidence-based psychological therapies available to people who hear distressing voices .


To identify genetic markers capable of predicting the pharmacokinetics , pharmacodynamics , and adverse effects of risperidone .


Genotyping was performed in @ healthy volunteers receiving a single @mg oral dose of risperidone .


Risperidone and hydroxyrisperidone plasma levels were measured using high-performance liquid chromatography combined with tandem mass spectrometry.Prolactin concentration was quantified by direct chemiluminescence .


Poor CYP@D@ metabolizers showed higher risperidone Cmax , area under the curve ( AUC ) , and t@/@ , as well as lower clearance .


They also showed lower Cmax and AUC and higher t@/@ for hydroxyrisperidone .


Furthermore , individuals with a mutant VKORC@ genotype had a lower risperidone AUC and t@/@ and higher clearance .


The hydroxyrisperidone AUC was lower in individuals with the COMT mutant genotype .


Risperidone increased prolactin levels ( iAUC and iCmax ) , which were higher in women than in men .


The most frequent reactions were somnolence ( @ % ) , headache ( @ % ) , and dizziness ( @ % ) .


Women had neurological effects and headache more frequently than men .


The incidence of headache was associated with polymorphisms in the AGTR@ and NAT@ ; neurological effects were associated with CYP@C@ .


Differences in the pharmacokinetics of risperidone are due to polymorphisms in CYP@D@ , COMT , and VKORC@ .


Differences in adverse reactions can be explained by gender and polymorphisms in CYP@C@ , AGTR@ , and NAT@ .


To investigate the clinical efficacy of X-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the Gasserian ganglion for treatment of primary trigeminal neuralgia .


This is a prospective , randomized study .


Sixty patients with primary trigeminal neuralgia were randomly assigned to a study group or control group .


In the study group , the patients underwent X-ray imaging combined with skin stimulation potential-guided percutaneous radiofrequency thermocoagulation of the Gasserian ganglion .


The patients in the control group underwent C-arm X-ray-guided puncture through the foramen ovale , and then the puncture needle was microscopically adjusted according to the intensity of the masticatory muscle response and the patients ' reactions .


Puncture success , postoperative adverse reactions , and short - and middle-term analgesic efficacies were statistically compared between the two surgical approaches .


The incidence of postoperative side effects was significantly reduced , and immediate and mid-term analgesic efficacy was better in patients in the study group comparing with those in the control group ( P < @ ) .


Using skin stimulation potential-guided puncture may enable more accurate microscopic adjustment of the targets localization damaged by radiofrequency and significantly enhanced clinical efficacy in this study .


To assess pregabalin monotherapy for partial-onset seizures using a historical-controlled conversion-to-monotherapy design .


Adults with inadequately controlled partial-onset seizures while receiving @ or @ antiepileptic drugs during an @-week prospective baseline were randomized to double-blind monotherapy with pregabalin @ or @ mg/d ( @:@ ) for @ weeks ( @-week conversion and @-week monotherapy period ) .


The primary endpoint was the seizure-related exit rate for pregabalin @ mg/d , based on discontinuations due to predefined criteria .


Efficacy was declared if the upper limit of the @ % confidence interval for the exit rate was below a historical-control threshold of @ % , with stepwise evaluation using a threshold of @ % .


The trial was stopped early for positive efficacy after an interim analysis in @ patients .


The full study population included @ patients , with @ evaluable for efficacy .


The mean time since epilepsy diagnosis was @ years .


Overall , @ % ( @ mg/d ) and @ % ( @ mg/d ) of patients completed @ weeks of double-blind treatment .


Seizure-related exit rate in the @ mg/d group ( @ % ; @ % confidence interval , @ % -@ % ) was significantly below the @ % and @ % thresholds ( p < @ for both ) .


Eight patients on @ mg/d and @ on @ mg/d were seizure-free throughout pregabalin monotherapy .


Pregabalin 's overall safety profile was consistent with prior trials .


Pregabalin monotherapy was safe and efficacious for patients with inadequately controlled partial-onset seizures .


This study provides Class III evidence that patients with inadequately controlled partial-onset seizures switched to pregabalin monotherapy have fewer seizure-related exit events compared with historical controls switched to pseudo-placebo monotherapy .


We investigated the method of switching EPO to CERA that does not cause a decrease in the Hb level .


Fifty EPO-treated patients were randomly divided into two groups in which CERA was administered every two weeks ( Q@W ) or every four weeks ( Q@W ) .


After @ weeks of treatment , the frequency of administration was changed to Q@W in the former .


Follow-up was performed for @ weeks .


There was no difference in the Hb level between the two groups until @ weeks .


In the Q@W group , the Hb maintained a stable level throughout a study period .


However , in the Q@W group , the Hb level was significantly lower than in the Q@W group at weeks @ , @ , and @ .


EPO switching to CERA without a decrease in the Hb level could be achieved by administering CERA every two weeks , but not every four weeks , for a specific period after switching .


Cardiovascular disease ( CVD ) and the underlying atherosclerosis begin in childhood , and their presence and intensity are related to known cardiovascular disease risk factors .


Attention to risk factor control in childhood has the potential to reduce subsequent risk of CVD .


The Young Hearts Strong Starts Study was designed to test strategies facilitating adoption of the National , Heart , Lung and Blood Institute supported Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents .


This study compares guideline-based quality measures for body mass index , blood pressure , and tobacco using two strategies : a multifaceted , practice-directed intervention versus standard dissemination .


Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations .


Individual practices were randomly assigned to the intervention or control groups using a cluster randomized design based on network affiliation , number of clinicians per practice , urban versus nonurban location , and practice type .


The units of observation are individual children because measure adherence is abstracted from individual patient 's medical records .


The units of randomization are physician practices .


This results in a multilevel design in which patients are nested within practices .


The intervention practices received toolkits and supported guideline implementation including academic detailing , an ongoing e-learning group .


This project is aligned with the American Board of Pediatrics Maintenance of Certification requirements including monthly physician self-abstraction , webinars , and other elements of the trial .


This trial will provide an opportunity to demonstrate tools and strategies to enhance CV prevention in children by guideline-based interventions .


Checklists may help reduce discharge errors ; however , current paper checklists have limited functionality .


In @ a best-practice discharge checklist using the electronic health record ( EHR ) was developed and evaluated at Stanford University Medical Center ( Stanford , California ) in a cluster randomized trial to evaluate its usage , user satisfaction , and impact on physicians ' work flow .


The study was divided into four phases .


In Phase I , on the survey ( N = @ ) , most of the participants ( @ % ) reported using memory to remember discharge tasks .


On a @-@ scale , perception of checklists as being useful was strong ( mean , @ ; standard deviation -LSB- SD -RSB- , @ ) , as was interest in EHR checklists ( @ , @ ) .


In Phase II , the checklist consisted of @ tasks categorized by admission , hospitalization , and discharge-planning .


In Phase III , the checklist was implemented as an EHR `` smart-phrase '' allowing for automatic insertion .


In Phase IV , in a trial with @ participating physicians , @ EHR checklist users reported higher usage than @ paper users ( @ versus @ , p = @ ) , as well as higher checklist integration with work flow ( @ versus @ , p = @ ) , usefulness of checklist ( @ versus .


@ , p = @ ) , discharge confidence ( @ versus @ , p = @ ) , and discharge efficiency ( @ versus @ , p = @ ) .


Increasing EHR checklist use was correlated with usefulness ( r = @ , p < @ ) , confidence ( r = @ , p < @ ) , and efficiency ( r = @ , p < @ ) .


The EHR checklist reminded physicians to complete discharge tasks , improved confidence , and increased process efficiency .


This is the first study to show that medicine residents use `` memory '' as the most common method for remembering discharge tasks .


These data reinforce the need for a formalized tool , such as a checklist , that residents can rely on to complete important discharge tasks .


Coordination of the tasks of performing chest compressions and defibrillation can lead to communication challenges that may prolong time spent off the chest .


The purpose of this study was to determine whether defibrillation provided by the provider performing chest compressions led to a decrease in peri-shock pauses as compared to defibrillation administered by a second provider , in a simulated cardiac arrest scenario .


This was a randomized , controlled study measuring pauses in chest compressions for defibrillation in a simulated cardiac arrest model .


We approached hospital providers with current CPR certification for participation between July , @ and October , @ .


Volunteers were randomized to control ( facilitator-administered defibrillation ) or experimental ( compressor-administered defibrillation ) groups .


All participants completed one minute of chest compressions on a mannequin in a shockable rhythm prior to administration of defibrillation .


We measured and compared pauses for defibrillation in both groups .


Out of @ total participants , we analyzed data from @ defibrillations .


Compressor-initiated defibrillation resulted in a significantly lower pre-shock hands-off time ( @ s ; @ % CI : @-@ @ ) compared to facilitator-initiated defibrillation ( @ s ; @ % CI : @-@ @ ) .


Furthermore , compressor-initiated defibrillation resulted in a significantly lower peri-shock hands-off time ( @ s ; @ % CI : @-@ @ ) compared to facilitator-initiated defibrillation ( @ s ; @ % CI : @-@ @ ) .


Assigning the responsibility for shock delivery to the provider performing compressions encourages continuous compressions throughout the charging period and decreases total time spent off the chest .


However , as this was a simulation-based study , clinical implementation is necessary to further evaluate these potential benefits .


The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics .


The appropriate duration of antimicrobial therapy remains unclear .


We randomly assigned @ patients with complicated intraabdominal infection and adequate source control to receive antibiotics until @ days after the resolution of fever , leukocytosis , and ileus , with a maximum of @ days of therapy ( control group ) , or to receive a fixed course of antibiotics ( experimental group ) for @ calendar days .


The primary outcome was a composite of surgical-site infection , recurrent intraabdominal infection , or death within @ days after the index source-control procedure , according to treatment group .


Secondary outcomes included the duration of therapy and rates of subsequent infections .


Surgical-site infection , recurrent intraabdominal infection , or death occurred in @ of @ patients in the experimental group ( @ % ) , as compared with @ of @ patients in the control group ( @ % ) ( absolute difference , -@ percentage point ; @ % confidence interval -LSB- CI -RSB- , -@ to @ ; P = @ ) .


The median duration of antibiotic therapy was @ days ( interquartile range , @ to @ ) in the experimental group , as compared with @ days ( interquartile range , @ to @ ) in the control group ( absolute difference , -@ days ; @ % CI , -@ to -@ ; P < @ ) .


No significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes .


In patients with intraabdominal infections who had undergone an adequate source-control procedure , the outcomes after fixed-duration antibiotic therapy ( approximately @ days ) were similar to those after a longer course of antibiotics ( approximately @ days ) that extended until after the resolution of physiological abnormalities .


( Funded by the National Institutes of Health ; STOP-IT ClinicalTrials.gov number , NCT@ . )


The genetic polymorphism concerning the @-subunit of platelet integrin receptor glycoprotein IIIa is held responsible for enhanced binding of adhesive proteins resulting in increased thrombogenic potential .


Whether it is associated with mortality , HbA@c or platelet volume is tested prospectively in an epidemiological cohort .


Population-based Cooperative Health Research in the Region of Augsburg ( KORA ) S@-Survey ( N = @,@ ) was investigated for prognostic value of PLA@A@-polymorphism regarding all-cause mortality , correlation with HbA@c , and mean platelet volume .


Multivariate analysis was performed to investigate association between genotype and key variables .


Prevalence of thrombogenic allele variant PLA@ was @ % .


Multivariate analysis revealed no association between PLA@A@ polymorphism and mortality in the KORA-cohort .


HbA@c was a prognostic marker of mortality in non-diabetic persons resulting in J-shaped risk curve with dip at HbA@c = @ % ( @ mmol/mol ) , confirming previous findings regarding aged KORA-S@ participants ( @-@ years ) .


PLA@A@ was significantly associated with elevated HbA@c levels in diabetic patients ( N = @ ) and reduced mean platelet volume in general population .


In non-diabetic participants ( N = @,@ ) , carriers of PLA@ allele variant presenting with HbA@c > @ % ( @ mmol/mol ) showed higher relative risk of mortality with increasing HbA@c .


PLA@A@ polymorphism is associated with mortality in participants with HbA@c ranging from @ % ( @ mmol/mol ) to @ % ( @ mmol/mol ) .


Maintenance of euglycemic control and antiplatelet therapy are therefore regarded as effective primary prevention in this group .


The large placebo effect observed in prior acupuncture trials presents a substantial challenge for interpretation of the efficacy of acupuncture .


We sought to evaluate the relationship between response expectancy , a key component of the placebo effect over time , and treatment outcome in real and sham electroacupuncture ( EA ) .


We analyzed data from a randomized controlled trial of EA and sham acupuncture ( SA ) for joint pain attributable to aromatase inhibitors among women with breast cancer .


Responders were identified using the Patient Global Impression of Change instrument at Week @ ( end of intervention ) .


The Acupuncture Expectancy Scale ( AES ) was used to measure expectancy four times during the trial .


Linear mixed-effects models were used to evaluate the association between expectancy and treatment response .


In the wait list control group , AES remained unchanged over treatment .


In the SA group , Baseline AES was significantly higher in responders than nonresponders ( @ vs @ , P = @ ) and AES did not change over time .


In the EA group , Baseline AES scores did not differ between responders and nonresponders ( @ vs @ , P = @ ) ; however , AES increased in responders compared with nonresponders over time ( P = @ for responder and time interaction term ) with significant difference at the end of trial for responders versus nonresponders ( @ vs @ , P = @ ) .


Baseline higher response expectancy predicts treatment response in SA , but not in EA .


Divergent mechanisms may exist for how SA and EA influence pain outcomes , and patients with low expectancy may do better with EA than SA .


We aimed to evaluate the effects of raw red onion consumption on metabolic features in overweight and obese women with polycystic ovary syndrome .


In this randomized controlled clinical trial , the patients ( n = @ ) were randomly allocated to the intervention group as ` high-onion ' ( raw red onions : @ @-@ g/day if overweight and @ @-@ g/day if obese ) or to the control group as ` low-onion ' ( raw red onions : @ @-@ g/day ) along with limited liliaceous vegetables for @ weeks .


Body mass index , dietary record , and metabolic parameters ( fasting blood sugar , triglycerides , total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and lipoprotein ( a ) ) were evaluated in the follicular phase of the menstrual cycle at baseline and after @ weeks .


Hormonal variables ( progesterone , prolactin , and @-OH progesterone ) were also measured at baseline .


Onion significantly decreased the levels of total cholesterol within each group ; however , these changes were stronger in the high-onion group ( weighted mean differences -LSB- WMD -RSB- : -@ -LSB- @ % confidence interval -LSB- CI -RSB- : -@ , -@ -RSB- ; P = @ ) than in the low-onion group ( WMD : -@ -LSB- @ % CI : -@ , -@ -RSB- ; P = @ ) .


Similarly , low-density lipoprotein cholesterol decreased significantly ( WMD : -@ -LSB- @ % CI : -@ , -@ ) ; P = @ ) in the high-onion group , and ( WMD : -@ -LSB- @ % CI -@ , -@ -RSB- ; P = @ ) in the low-onion group after treatment .


The levels of fasting blood sugar , triglycerides , high-density lipoprotein cholesterol and lipoprotein ( a ) did not differ significantly after @-week onion treatment .


Adjustment for confounders did not make any significant changes in any of the parameters in post-treatment levels .


Raw red onion consumption appears to be effective as a cholesterol-lowering food agent in women with polycystic ovary syndrome .


However , further investigation is warranted .


Elderly patients are at high risk for both ischemic and bleeding events .


Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio .


The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel @ mg as compared with a more conventional strategy using prasugrel @ mg without monitoring and without adjustment ( Conventional Treatment Arm ) to reduce the primary end point evaluated @ year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome ( ACS ) .


ANTARCTIC is a multicenter , prospective , open-label study with @ parallel arms .


A total of @ elderly patients ( @ years ) undergoing stent percutaneous coronary intervention for ACS are to be enrolled .


The primary end point is the time to first occurrence of cardiovascular death , myocardial infarction , stroke , definite stent thrombosis , urgent revascularization , and bleeding complications ( Bleeding Academic Research Consortium definition @ , @ , or @ ) .


Platelet function analyses will be performed @ days after randomization and repeated @ days later in patients who require a change in treatment .


ANTARCTIC is a nationwide , prospective , open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting .


Vaniprevir ( MK-@ ) is a hepatitis C virus ( HCV ) non-structural @/@a protease inhibitor which significantly increases virologic response rates in HCV genotype ( GT ) @-infected patients when added to peginterferon and ribavirin ( PR ) .


This was a phase II , multicenter , double-blind , randomized , dose-ranging study in Japanese patients with HCV GT@ infection and previous relapse .


Patients received twice daily vaniprevir @ , @ , or @ mg , or placebo plus PR for @ weeks then PR alone for @ weeks .


Further treatment with PR was continued up to a maximum of @ weeks .


The primary endpoint was rapid virologic response ( RVR ; undetectable HCV RNA at treatment week @ ) .


Ninety patients completed @ weeks of vaniprevir/placebo plus PR .


Rates of RVR were significantly higher with vaniprevir compared with placebo ( @ , @ , and @ % in the vaniprevir @ - , @ - , and @-mg arms versus @ % with control ; p < @ for all comparisons ) .


Rates of SVR , an exploratory analysis , in the vaniprevir @ - , @ - , @-mg , and control arms were @ , @ , @ , and @ % , respectively .


No patient had virologic breakthrough or non-response while receiving vaniprevir .


There were no serious adverse events ( AEs ) or discontinuations due to an AE during vaniprevir treatment .


Diarrhea and nausea were more common with vaniprevir @ mg than control or lower vaniprevir doses .


The addition of vaniprevir to PR was associated with an increase in RVR and SVR .


Combined with a generally safe and well-tolerated profile , these data supported the further evaluation of vaniprevir in Japanese patients with HCV GT@ infection ( #NCT @ ) .


The aim of this study was to gain further understanding of placebo response in binge eating disorder .


We pooled participant-level data from @ double-blind , placebo-controlled , randomized trials of medications for binge eating disorder .


The primary outcomes were response ( @ % reduction in binge eating episodes ) , cessation of binge eating episodes , change in mean weekly binge eating episodes and binge eating episodes per week .


Of @ participants receiving placebo , @ ( @ % ) were responders and @ ( @ % ) attained cessation .


Placebo-treated participants significantly reduced their binge eating .


The mean ( SD ) binge eating episodes per week at baseline was @ ( @ ) and at endpoint was @ ( @ ) .


Lower baseline binge eating episode frequency and longer study participation were significantly associated with response and cessation .


Less severe eating pathology at baseline was associated with higher placebo response and cessation rates .


Future clinical trials may want to stipulate that participants exceed a threshold of illness severity , which may lead to better placebo and drug separation .


Although BiPAP has been used as an adjunct to exercise , little is know about its effect on exercise in COPD .


We aimed to evaluate the acute effect of BiPAP delivered with a standard valve ( Vision , Respironics ) , compared to no assist , on exercise capacity in individuals with COPD .


Peak exercise workload ( WLpeak ) , dyspnea ( Borg ) , end-expiratory lung volume ( EELV ) , tidal volume ( VT ) , minute ventilation ( VE ) , O@ uptake ( VO@ ) , and CO@ production ( VCO@ ) were assessed in @ COPD patients ( FEV@ @ @ % pred ) during three symptom-limited bicycle exercise tests while breathing i ) without a ventilator ( noPS ) , ii ) with a pressure support ( PS ) of @ cm H@O ( PS@ ; IPAP & EPAP @ cm H@O ) and iii ) PS of @ cm H@O ( PS@ ; IPAP @ & EPAP @ cm H@O ) on separate days using a randomized crossover design .


WLpeak was significantly lower with PS@ ( @ @ ) and PS@ ( @ @ ) than noPS ( @ @ ) ( p < @ ) .


Dyspnea at peak exercise was similar with noPS , PS@ and PS@ ; at isoload it was lower with noPS compared to PS@ and PS@ ( p < @ ) .


VT and VE were highest with PS@ and lowest with noPS both at peak exercise and isoload ( p < @ ) .


EELV was similar at peak exercise with all three conditions .


VO@ and VCO@ were greater with PS@ and PS@ than noPS ( p < @ ) , both at peak exercise and isoload .


Use of BiPAP with a standard exhalation valve during exercise increases VT and VE at the expense of augmenting VCO@ and dyspnea , which in turns reduces WLpeak in COPD patients .


Heart rate characteristics monitoring for early detection of late-onset neonatal sepsis was first described in @ .


This technique , which uses mathematical methods to report the fold-increase in the risk of imminent neonatal sepsis , adds independent information to laboratory tests and clinical findings , and , in a large randomized trial , reduced NICU mortality of very low birth weight infants .


Through re-analysis and new secondary analyses of published studies , we have systematically evaluated the utility of this new risk marker for screening the growing population of premature infants .


We followed the guidelines proposed by Hlatky et al. ( Circulation , @:@ -@ , @ ) , reviewed past works , and re-analyzed data from @,@ patients receiving conventional monitoring alone , @ of whom had @ episodes of proven sepsis , in the large randomized trial .


Heart rate characteristics monitoring passed all phases of risk marker development from proof of concept to improvement of clinical outcomes .


The predictiveness curve affirmed good calibration , and addition of the heart rate characteristics index to predictive models using standard risk factors favorably impacted the receiver operating characteristic curve area ( increase of @ ) , continuous net reclassification index ( @ ) and the integrated discrimination index ( @ ) , and compares well to other modern risk factors .


Heart rate characteristics monitoring is a validated risk marker for sepsis in the NICU .


Combining a long-acting muscarinic antagonist with a long-acting - agonist has been shown to be pharmacologically useful in patients with chronic obstructive pulmonary disease ( COPD ) .


The aim of the present study was to evaluate the effectiveness of the dual bronchodilator therapy on airway dimensions in COPD .


Patients ( n = @ ) were randomly assigned to receive tiotropium ( @g once daily ) , indacaterol ( @g once daily ) or tiotropium plus indacaterol for @ weeks .


Quantitative computed tomography ( CT ) , pulmonary function and health status ( St. George 's Respiratory Questionnaire ) were measured .


Compared with tiotropium or indacaterol alone , combination therapy resulted in a significant decrease in percentage wall area ( WA % ) and wall thickness , corrected for body surface area , and an increase in luminal area ( Ai/BSA ) .


Concurrent treatment was superior to monotherapy in physiological indices , including forced vital capacity , forced expiratory volume in @s ( FEV ) and inspiratory capacity .


The changes in WA % and Ai/BSA were significantly correlated with changes in FEV ( r = -@ , P < @ and r = @ , P < @ ) .


There were more significant improvements in SGRQ scores after treatment with combined therapy than with either treatment alone .


Concurrent therapy with tiotropium and indacaterol is effective for COPD patients to promote reduction in airway wall thickness , bronchodilation , and improvements in lung function compared with a single inhaler .


To determine the subjective and objective outcomes of retroperitoneoscopic vs open pyeloplasty with minimal incision in a prospective randomized comparison study .


In this study between August @ to July @ , @ patients underwent retroperitoneal laparoscopic pyeloplasty and @ open pyeloplasty with minimal incision ( incision length < @ cm ) after randomization .


The @ groups were compared for the visual pain score on the first and second postoperative days as the primary end point of the study .


Complications were recorded and graded using Dindo-modified Clavien classification of surgical complications .


Success rates were evaluated by improvement in pain score and objectively by diethylene triamine penta-acetic acid renal scan and other parameters .


Statistical analysis was performed with SPSS version @ ( IBM ) with P < @ considered statistically significant .


The difference in the visual pain score ( @ vs @ on day @ ; @ vs @ on day @ ) and the diclofenac requirements ( @ vs @ mg ) were statistically significant and more in the open pyeloplasty .


The hospital stay and convalescence were significantly lower in retroperitoneoscopic group .


Success rate was found to be @ % with @ failure in each group .


Two patients in retroperitoneoscopic group required conversion .


Both groups showed significant improvement in pain score and drainage pattern on diethylene triamine penta-acetic acid scan with decrease in hydronephrosis on ultrasound evaluation .


Although subjective and objective outcomes are equivalent in both the groups , the retroperitoneoscopic approach is associated with significantly less pain , less analgesic requirement , shorter hospital stay and short convalescence in comparison with open pyeloplasty .


The stimulant prodrug lisdexamfetamine dimesylate ( LDX ) is an effective and generally well tolerated treatment for the symptoms of attention-deficit/hyperactivity disorder ( ADHD ) .


Positive impacts of LDX on health-related quality of life and functional impairment have previously been demonstrated in a @-week , randomized , double-blind , placebo-controlled , phase III study in children and adolescents in Europe .


Maintenance of these broad benefits , as well as symptomatic control , is a key goal of long-term management of ADHD .


Secondary objectives of this multinational study in children and adolescents with ADHD were to assess the long-term maintenance of effectiveness of LDX in improving health-related quality of life and reducing functional impairment , as gauged using the Child Health and Illness Profile-Child Edition : Parent Report Form ( CHIP-CE : PRF ) and the Weiss Functional Impairment Rating Scale-Parent Report ( WFIRS-P ) , respectively .


Patients aged @-@ years with diagnosed ADHD and a baseline ADHD Rating Scale IV total score of at least @ were enrolled from the previous European study and from US sites .


Patients who completed an open-label LDX treatment period of at least @ weeks were randomized ( @:@ ) to continue on their optimized dose of LDX or to switch to placebo for a @-week , double-blind , withdrawal period .


Parents completed CHIP-CE : PRF and WFIRS-P questionnaires at weeks @ , @ and @ of the open-label period and at weeks @ and @ of the randomized-withdrawal period , or at early termination .


The endpoint of each period was defined as the last visit with valid data .


Effect sizes were the difference ( LDX minus placebo ) in least-squares ( LS ) - mean change from baseline to endpoint divided by root-mean-square error .


P values were nominal and not adjusted for multiple comparisons .


The open-label and randomized full analysis sets comprised @ and @ ( LDX n = @ ; placebo n = @ ) patients , respectively .


Mean pretreatment CHIP-CE : PRF T-scores were more than one standard deviation below the normative mean in four of the five domains , and there was significant improvement across all domains from baseline to endpoint of the open-label period .


In the randomized-withdrawal period , LS-mean CHIP-CE : PRF T-scores deteriorated in all domains in the placebo group , but not in the LDX group .


Compared with placebo , the effect of LDX was significant in the Risk Avoidance ( effect size @ ; p < @ ) , Achievement ( @ ; p < @ ) and Satisfaction ( @ ; p < @ ) domains .


Mean pretreatment WFIRS-P scores were lowest in the Family domain and the Learning and School domain .


WFIRS-P total score and scores in all domains improved significantly from baseline to endpoint of the open-label period .


In the randomized-withdrawal period , LS-mean scores deteriorated in the placebo group but not in the LDX group .


Compared with placebo , the effect of LDX was significant in the Family , Learning and School , and Risky Activities domains and in total ( effect size @ ; p < @ ) .


Using parent-rated instruments , long-term maintenance of the beneficial effect of LDX in multiple domains of health-related quality of life and functional impairment was demonstrated by comparison of treatment continuation and withdrawal under randomized , double-blind , placebo-controlled conditions .


The effects of dietary fatty acid supplementation on lipoprotein fatty acid composition have rarely been described .


Sixty-one overweight and obese adults with dyslipidemia and insulin resistance were randomized to placebo , @g/day extended-release nicotinic acid ( ERN ) , @g/day prescription omega-@ fatty acid ethyl ester ( P-OM@ ) , or combination therapy for @ weeks .


Lipoprotein fatty acid composition was analyzed by gas chromatography pre - and post-treatment .


Treatment with P-OM@ or combination , but not ERN , increased proportions of eicosapentaenoic acid , docosahexaenoic acid , and docosapentaenoic acid , and reduced those for arachidonic acid in all lipoprotein fractions , with greatest impact in the high-density lipoprotein fraction .


P-OM@-induced changes in eicosapentaenoic acid within low-density lipoproteins and very low-density lipoproteins were associated with beneficial effects on mean arterial pressure and pulse pressure .


P-OM@ supplementation , with or without ERN , was associated with differentially altered lipoprotein fatty acid composition and improved blood pressure parameters .


To evaluate the pharmacokinetics of oral canagliflozin and its O-glucuronide metabolites ( M@ and M@ ) after single and multiple doses in healthy adult participants .


The pharmacodynamics , safety , and tolerability of canagliflozin were also evaluated .


In this open-label , single - ( day @ ) and multiple-dose ( days @-@ ) , parallel-group , phase @ study , @ healthy participants were randomized into three groups ( @:@:@ ) to receive @ , @ , or @ mg canagliflozin .


Pharmacokinetics and pharmacodynamics were assessed at pre-pecified timepoints on days @ , @ , and @ .


Mean area under the plasma concentration-time curve , and the maximum observed plasma concentration of canagliflozin , M@ , and M@ increased in a dose-dependent manner , across all the @ doses , following single - and multiple-dose administration .


The mean apparent elimination half-lives of canagliflozin , M@ , and M@ were independent of the dose .


Canagliflozin decreased the renal threshold for glucose ( RTG ) and increased the urinary glucose excretion ( UGE ) in a concentration - and dose-dependent manner .


The relationship between drug concentrations and RTG was described by a sigmoidal relationship with RTGmin ( minimum value of RTG ) of @ ng/mL ( @ % confidence interval ( CI ) : @ , @ ) and half-maximal effective concentration ( EC@ ) of @ ng/mL ( @ % CI : @ , @ ) .


No deaths , serious adverse events , hypoglycemic events , or discontinuations due to adverse events were observed .


Pharmacokinetics of canagliflozin and its metabolites ( M@ and M@ ) were linear , and no time-dependent changes were observed after single - and multiple-dose administration .


Similarly , pharmacodynamic effects of canagliflozin on RTG and UGE were found to be dose - and concentration-dependent .


Overall , canagliflozin was well-tolerated in healthy participants .


Neuroendocrine and immune stresses imposed by chronic sleep restriction are known to be involved in the harmful cardiovascular effects associated with poor sleep .


Despite a well-known beneficial effect of napping on alertness , its effects on neuroendocrine stress and immune responses after sleep restriction are largely unknown .


This study was a strictly controlled ( sleep-wake status , light environment , caloric intake ) , crossover , randomized design in continuously polysomnography-monitored subjects .


The study was conducted in a laboratory-based study .


The subjects were @ healthy young men .


We investigated the effects on neuroendocrine and immune biomarkers of a night of sleep restricted to @ h followed by a day without naps or with @ minute morning and afternoon naps , both conditions followed by an ad libitum recovery night starting at @:@ .


Salivary interleukin-@ and urinary catecholamines were assessed throughout the daytime study periods .


The increase in norepinephrine values seen at the end of the afternoon after the sleep-restricted night was not present when the subjects had the opportunity to take naps .


Interleukin-@ changes observed after sleep deprivation were also normalized after napping .


During the recovery day in the no-nap condition , there were increased levels of afternoon epinephrine and dopamine , which was not the case in the nap condition .


A recovery night after napping was associated with a reduced amount of slow-wave sleep compared to after the no-nap condition .


Our data suggest that napping has stress-releasing and immune effects .


Napping could be easily applied in real settings as a countermeasure to the detrimental health consequences of sleep debt .


Prior research has indicated that the loss of skeletal muscle mass and bone mineral density observed with aging is related to the prominent age-related decline in the concentration of serum growth hormone ( GH ) .


However , there is limited data on the effects of aging on GH responses to acute bouts of heavy resistance exercise ( HRE ) and aerobic exercise ( AE ) .


The present investigation examined the effects of a HRE protocol and an AE protocol on immunoreactive GH ( IGH ) and bioactive GH ( BGH ) in active young and old women .


Older women had a diminished serum IGH response to both the HRE and AE protocols compared to the younger women , however a similar response was not observed in serum BGH .


Additionally , the HRE protocol elicited a greater BGH response than the AE protocol exclusively in the younger group .


Regardless of exercise mode , aging induces an increase in growth hormone polymerization that specifically results in a loss of serum growth hormone immunoreactivity without a concurrent loss of serum growth hormone bioactivity .


The greater BGH response to the HRE protocol found in the younger group can be attributed to an unknown serum factor of molecular weight between @ and @kD that either potentiated growth hormone bioactivity in response to HRE or inhibited growth hormone bioactivity in response to AE .


Behavioral measures are often used to distinguish subgroups of patients with stroke ( eg , to predict treatment gains , stratify clinical trial enrollees , or select rehabilitation therapy ) .


In studies of the upper extremity , measures of brain function using functional magnetic resonance imaging ( fMRI ) have also been found useful , but this approach has not been examined for the lower extremity .


The current study hypothesized that an fMRI-based measure of cortical function would significantly improve prediction of treatment-induced lower extremity behavioral gains .


Biomarkers of treatment gains were also explored .


Patients with hemiparesis @ to @ months after stroke were enrolled in a double-blind , placebo-controlled , randomized clinical trial of ropinirole + physical therapy versus placebo + physical therapy , results of which have previously been reported ( NCT@ ) .


( @ ) Primary end point was change in gait velocity .


Enrollees underwent baseline multimodal assessment that included @ measures spanning @ assessment categories ( medical history , impairment , disability , brain injury , and brain function ) , and also underwent reassessment @ weeks after end of therapy .


In bivariate analysis , @ baseline measures belonging to @ categories ( medical history , impairment , disability , and brain function ) significantly predicted change in gait velocity .


Prediction was strongest , however , using a multivariate model containing @ measures ( leg Fugl-Meyer score and fMRI activation volume within ipsilesional foot sensorimotor cortex ) .


Increased activation volume within bilateral foot primary sensorimotor cortex correlated positively with treatment-induced leg motor gains .


A multimodal model incorporating behavioral and fMRI measures best predicted treatment-induced changes in gait velocity in a clinical trial setting .


Results also suggest potential use of fMRI measures as biomarkers of treatment gains .


To investigate the effect of overnight orthokeratology ( OK ) contact lens wear on axial length growth in East Asian children with progressive myopia .


A prospective , randomized , contralateral-eye crossover study conducted over a @-year period .


We enrolled @ myopic children ( age range , @-@ @ years ) of East Asian ethnicity .


Subjects were fitted with overnight OK in @ eye , chosen at random , and conventional rigid gas-permeable ( GP ) lenses for daytime wear in the contralateral eye .


Lenses were worn for @ months .


After a @-week recovery period without lens wear , lens-eye combinations were reversed and lens wear was continued for a further @ months , followed by another @-week recovery period without lens wear .


Axial eye length was monitored at baseline and every @ months using an IOLMaster biometer .


Corneal topography ( Medmont E@ ) and objective refraction ( Shin-Nippon NVision-K @ autorefractor ) were also measured to confirm that OK lens wear was efficacious in correcting myopia .


Axial length elongation and myopia progression with OK were compared with conventional daytime rigid contact lens wear .


After @ months of lens wear , axial length had increased by @ mm ( meanstandard deviation ) in the GP eye ( P = @ ) but showed no change ( -@ mm ) in the OK eye ( P = @ ) .


During the second @-month phase of lens wear , in the OK eye there was no change from baseline in axial length at @ months ( -@ mm ; P = @ ) .


However , in the GP eye , the @-month increase in axial length was significant ( @ mm ; P < @ ) .


The GP lens-wearing eye showed progressive axial length growth throughout the study .


These results provide evidence that , at least in the initial months of lens wear , overnight OK inhibits axial eye growth and myopia progression compared with conventional GP lenses .


Apparent shortening of axial length early in OK lens wear may reflect the contribution of OK-induced central corneal thinning , combined with choroidal thickening or recovery due to a reduction or neutralization of the myopiogenic stimulus to eye growth in these myopic children .


Obsessive-compulsive disorder ( OCD ) is a very disabling condition with a chronic course , if left untreated .


Though cognitive behavioral treatment ( CBT ) with or without selective serotonin reuptake inhibitors ( SSRI ) is the method of choice , up to one third of individuals with obsessive-compulsive disorder ( OCD ) do not respond to treatment in terms of at least @ % improvement of symptoms .


Mindfulness based cognitive therapy ( MBCT ) is an @-week group program that could help OCD patients with no or only partial response to CBT to reduce OC symptoms and develop a helpful attitude towards obsessions and compulsive urges .


This study is a prospective , bicentric , assessor-blinded , randomized , actively-controlled clinical trial .


@ patients with primary diagnosis of OCD according to DSM-IV and no or only partial response to CBT will be recruited from in - and outpatient services as well as online forums and the media .


Patients will be randomized to either an MBCT intervention group or to a psycho-educative coaching group ( OCD-EP ) as an active control condition .


All participants will undergo eight weekly sessions with a length of @ minutes each of a structured group program .


We hypothesize that MBCT will be superior to OCD-EP in reducing obsessive-compulsive symptoms as measured by the Yale-Brown-Obsessive-Compulsive Scale ( Y-BOCS ) following the intervention and at @ - and @-months-follow-up .


Secondary outcome measures include depressive symptoms , quality of life , metacognitive beliefs , self-compassion , mindful awareness and approach-avoidance tendencies as measured by an approach avoidance task .


The results of this study will elucidate the benefits of MBCT for OCD patients who did not sufficiently benefit from CBT .


To our knowledge , this is the first randomized controlled study assessing the effects of MBCT on symptom severity and associated parameters in OCD .


Blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore .


To investigate if repetitive sessions of photodynamic therapy ( PDT ) using external application of liposomal Rose bengal ( RB ) photosensitizer followed by intense pulsed light ( IPL ) exposure enables removal of gray and white hair .


Rose bengal loaded in liposomes ( LRB ) was constructed , prepared in hydrogel , and was studied for some pharmaceutical properties .


Penetration and selective hair follicle damage in mice skin were studied .


Topical gel containing LRB was used for treating fifteen adult females who were complaining of facial white terminal hair .


Unwanted facial hair was treated for three sessions at intervals of @-@ weeks using intense pulsed light ( IPL ) .


At each session , the treatment area was pre-treated with topical LRB gel , while a control group of another @ patients applied placebo gel before IPL treatment .


Evaluations included hair regrowth , which was measured @ weeks after each treatment session and at @ months follow-up by counting the number of terminal hair compared with baseline pretreatment values .


Treatment outcomes and complications if any were also reported .


Average hair regrowth in the LRB group was @ % after @ treatment cycles .


After six-months follow up , average terminal hair count compared with baseline pretreatment showed @ % reduction and no recorded side effects .


A significant difference ( P < @ ) was seen compared with the control group ; the clinical results were promising .


Photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with IPL treatment showed significant efficacy in the treatment of white hair compared with a control group .


Limited data describe patient-reported outcomes ( PROs ) of localised oesophageal cancer treated with definitive chemoradiotherapy ( CRT ) .


The phase @/@ SCOPE-@ trial assessed the effectiveness of CRTcetuximab .


The trial for the first time provided an opportunity to describe PROs from a multi-centre group of patients treated with CRT that are presented here .


Patients undergoing CRTcetuximab within the SCOPE-@ trial ( @ patients from @ UK centres ) completed generic - , disease - and treatment-specific health-related quality of life ( HRQL ) questionnaires ( EORTC QLQ-C@ , QLQ-OES@ , Dermatology Life-Quality Index ( DLQI ) ) at baseline and at @ , @ , @ , @ and @ weeks .


Mean EORTC functional scale scores ( > @ point change significant ) , DLQI scores ( > @ point change significant ) and proportions of patients ( > @ % significant ) with ` minimal ' or ` severe ' symptoms are presented .


Questionnaire response rates were good .


At baseline , EORTC functional scores were high ( > @ % ) and few symptoms were reported except for severe problems with fatigue , insomnia and eating-related symptoms ( e.g. , appetite loss , dysphagia , dry mouth ) in both groups ( > @ % ) .


Functional aspects of health deteriorated and symptoms increased with treatment and by week @ global quality of life , physical , role and social function significantly deteriorated and more problems with fatigue , dyspnoea , appetite loss and trouble with taste were reported .


Recovery occurred by @ months ( except severe fatigue and insomnia in > @ % of patients ) and maintained at follow-up with no differences between groups .


CRT for localised oesophageal cancer has a significant detrimental impact on many aspects of HRQL ; however , recovery is achieved by @ months and maintained with the exception of persisting problems with severe fatigue and insomnia .


The data suggest that the HRQL recovery after definitive CRT is quicker , and there is little lasting deficit compared with treatment including surgery .


These data need to be compared with HRQL data from studies evaluating treatments including surgery for oesophageal cancer .


Ischemic heart disease is a leading worldwide cause of death .


The Seattle Post Myocardial Infarction Model ( SPIM ) was developed to predict survival @ months to @ years after an acute myocardial infarction with evidence of left ventricular dysfunction .


A total of @ subjects from the EPHESUS trial were used to derive the predictive model , while @ subjects from the OPTIMAAL trial were used to validate the model .


Cox proportional hazards modeling was used to develop a multivariate risk score predictive of all-cause mortality .


The SPIM risk score integrated lab and vital parameters , Killip class , reperfusion or revascularization , the number of cardiac evidence-based medicines ( aspirin , statin , blocker , ACEI/ARB , aldosterone blocker ) , and the number of cardiac risk factors .


The model was predictive of all-cause mortality after myocardial infarction , with an AUC of @ at @ months and @ at @ years in the derivation cohort and @ and @ for the same time points in the validation cohort .


Model predicted versus Kaplan-Meier observed survival was excellent in the derivation cohort .


It remained so in the validation cohort -- @ % versus @ % at @ years .


The @ % of subjects with the highest predicted risk had approximately @ times higher mortality at @ years than the @ % of subjects with the lowest predicted risk .


The SPIM score was a powerful predictor of outcomes after myocardial infarction with left ventricular dysfunction .


Its highly accurate predictions should improve patient and physician understanding of survival and may prove a useful tool in post-infarct risk stratification .


To evaluate the effect of finasteride on serum androst-@-ene-@ ,@ - dione ( androstenedione ) and its association with prostate cancer risk among subjects who participated in the Prostate Cancer Prevention Trial .


We analyzed serum androstenedione levels in @ prostate cancer cases and @ controls , nested in the Prostate Cancer Prevention Trial , a randomized placebo-controlled trial that found finasteride decreased prostate cancer risk .


Androstenedione is the second most important circulating androgen in men besides testosterone and also a substrate for @-reductase enzyme .


We observed a @ % increase in androstenedione levels compared with the baseline values in subjects who were treated with finasteride for @ years .


This significant increase did not vary by case-control status .


Adjusted odds ratio and @ % confidence interval for the third tertile of absolute change in androstenedione levels compared with the first tertile were @ ( @ % confidence interval , @-@ @ ) for low-grade ( Gleason score < @ ) cases .


Similar results were observed when analyzed using percent change .


There were no significant associations between serum androstenedione levels and the risk of high-grade disease .


The results of this nested case-control study confirm that finasteride blocks the conversion of testosterone to dihydrotestosterone ( DHT ) and of androstenedione to @-androstanedione-@ ,@ - dione , which also leads to the reduction of DHT formation .


This decrease in DHT may help reduce the risk of low-grade prostate cancer in men .


Our data on a differential effect of androstenedione also suggest that some high-grade prostate cancers may not require androgen for progression .


Vasopressin and corticosteroids are both commonly used adjunctive therapies in septic shock .


Retrospective analyses have suggested that there may be an interaction between these drugs , with higher circulating vasopressin levels and improved outcomes in patients treated with both vasopressin and corticosteroids .


We aimed to test for an interaction between vasopressin and corticosteroids in septic shock .


Prospective open-label randomized controlled pilot trial .


Four adult ICUs in London teaching hospitals .


Sixty-one adult patients who had septic shock .


Initial vasopressin IV infusion titrated up to @ U/min and then IV hydrocortisone ( @ mg @ hourly ) or placebo .


Plasma vasopressin levels were measured at @-@ and @-@ hours after hydrocortisone/placebo administration .


Thirty-one patients were allocated to vasopressin + hydrocortisone and @ patients to vasopressin + placebo .


The hydrocortisone group required a shorter duration of vasopressin therapy ( @ d ; @ % CI , @-@ @ ; shorter in hydrocortisone group ) and required a lower total dose of vasopressin ( ratio , @ ; @ % CI , @-@ @ ) compared with the placebo group .


Plasma vasopressin levels were not higher in the hydrocortisone group compared with the placebo group ( @ pmol/L difference at @ - to @-hour time point ; @ % CI , -@ to @ pmol/L ) .


Early vasopressin use was well tolerated with only one serious adverse event possibly related to study drug administration reported .


There were no differences in mortality rates ( @ % @-day mortality in both groups ) or organ failure assessments between the two treatment groups .


Hydrocortisone spared vasopressin requirements , reduced duration , and reduced dose , when used together in the treatment of septic shock , but it did not alter plasma vasopressin levels .


Further trials are needed to assess the clinical effectiveness of vasopressin as the initial vasopressor therapy with or without corticosteroids .


Current holistic rehabilitation blends both physical and psychological techniques .


However , validation of the usefulness of psychological strategies is limited in the literature .


To quantify the effects of psychological strategies on both physiologic ( salivary cortisol ) and subjective assessments of stress .


Randomized controlled clinical trial .


Laboratory .


A total of @ college-aged students ( age = @ @ years ) , most with little to no experience with psychological strategies .


A @-minute script via an iPod led the participant through visual imagery ( cognitive relaxation ) or deep breathing exercises ( somatic relaxation ) cues .


The control group listened to @ minutes of ambient nature sounds .


Two samples ( pretest , posttest ) of salivary cortisol were analyzed using an enzyme immunoassay kit ; the average was used for statistical analysis .


Descriptive statistics and correlations were conducted to examine group differences in time of day , salivary cortisol , sex , Stress-O-Meter values , and Perceived Stress Scale scores .


Salivary cortisol levels were lower in the treatment group than the control group ( F@ ,@ = @ , P < @ ) .


Females had higher scores on both the pretest Stress-O-Meter ( @ @ ) and the Perceived Stress Scale ( @ @ ) than males ( @ @ and @ @ , respectively ) .


Both cognitive and somatic relaxation strategies reduced cortisol levels .


Participants who received verbal guidance achieved a larger cortisol reduction .


However , the change in cortisol level was uncorrelated with the change in report of acute stress ; females reported higher levels of stress .


Clinical implications include attention to sex when assessing stress and providing coping skills during the rehabilitation process .


To explore the efficiency of single application of lobaplatin in tran-scatheter arterial chemoembolization ( TACE ) for patients with a primary hepatic carcinoma who were unable or unwilling to undergo surgery .


@ patients with primary hepatic carcinoma diagnosed by imaging or pathology were randomly divided into experimental and control groups and respectively treated with lobaplatin and pirarubicin hydrochloride as chemotherapeutic drugs for TACE .


The amount of iodipin was regulated according to the tumor number and size , and then gelatin sponge or polyvinyl alcohol particles were applied for embolisms .


The efficiency of treatment in the two groups was compared with reference to survival time and therapeutic response .


The experimental group ( single lobaplatin as chemotherapy drug ) was superior to control group ( single pirarubicin hydrochloride as chemotherapy drug ) in the aspects of survival time and therapeutic response , with statistical significance .


Single lobaplatin can be as a chemotherapy drug in TACE and has better efficiency in the aspects of mean survival time and therapeutic response , deserving to be popularized in the clinic .


The primary objective of this study was to compare Aquacel ( ConvaTec , Skillman , New Jersey ) , Allevyn ( Smith & Nephew , St Petersburg , Florida ) , and Mediskin I ( Mlnlycke , Health Care AB , Gothenburg , Sweden ) in the treatment of split-thickness skin graft donor sites .


This study was performed as a prospective randomized , @-arm , clinical study .


A clinical study performed at a hand and plastic surgery department with burn unit .


The study included @ adults with a total of @ donor sites , which were on the thigh , not reharvested , and ranged between @ - and @-cm area .


Subjects were randomly assigned to treatment with Aquacel , Allevyn , or Mediskin I.


The donor site was assessed on postoperative days @ , @ , and @ for healing , infection , pain , impact on everyday life , ease of use , and cost .


The obtained results demonstrate significantly faster re-epithelialization for patients treated with Aquacel or Mediskin I compared with Allevyn .


Regarding infections , there were no significant differences between the groups .


Patients wearing Aquacel experienced significantly less pain changing the dressing and less impact on everyday life than the patients wearing Allevyn .


Aquacel was shown to be significantly easier for the caregiver to use than Allevyn and Mediskin I.


There is a significant difference in cost of treatment between the dressings , whereas Mediskin I is the most expensive .


The authors ' results support the use of Aquacel in the treatment of split-thickness skin graft donor sites .


Aquacel has a low cost per unit , is user friendly , gives short healing time , and minimizes patient discomfort .