Tramadol for epigastric pain relief was more frequent ( p = @ ) in the placebo group ( @ % ) than in the DEXA group ( @ % ) .


No differences were noted between groups in length of stay or complications , including acute or delayed bleeding .


The distribution of artificial ulcer patterns at @-h post-ESD as determined by second-look endoscopy was similar in both groups .


Single-dose perioperative intravenous dexamethasone after ESD effectively relieved epigastric pain @ h postoperatively .


Dabigatran and warfarin have been compared for the treatment of acute venous thromboembolism ( VTE ) in a previous trial .


We undertook this study to extend those findings .


In a randomized , double-blind , double-dummy trial of @ patients with acute VTE treated with low-molecular-weight or unfractionated heparin for @ to @ days , we compared dabigatran @ mg twice daily with warfarin .


The primary outcome , recurrent symptomatic , objectively confirmed VTE and related deaths during @ months of treatment occurred in @ of the @ dabigatran patients ( @ % ) compared with @ of the @ warfarin patients ( @ % ; hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; absolute risk difference , @ % ; @ % CI , -@ to @ ; P < @ for the prespecified noninferiority margin for both criteria ) .


The safety end point , major bleeding , occurred in @ patients receiving dabigatran ( @ % ) and in @ receiving warfarin ( @ % ; hazard ratio , @ ; @ % CI , @-@ @ ) .


Any bleeding occurred in @ dabigatran ( @ % ) and @ warfarin ( @ % ; hazard ratio , @ ; @ % CI , @-@ @ ) patients .


Deaths , adverse events , and acute coronary syndromes were similar in both groups .


Pooled analysis of this study RE-COVER II and the RE-COVER trial gave hazard ratios for recurrent VTE of @ ( @ % CI , @-@ @ ) , for major bleeding of @ ( @ % CI , @-@ @ ) , and for any bleeding of @ ( @ % CI , @-@ @ ) .


Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE .


Peer teaching is now used in medical education with its value increasingly being recognised .


It is not yet established whether students differ in their satisfaction with teaching by peer-teachers compared to those taught by academic or clinical staff .


This study aimed to establish satisfaction with communication skills teaching between these three teaching groups .


Students participated in a role-play practical facilitated either by clinicians , peer-teachers or non-clinical staff .


A questionnaire was administered to first-year medical students after participating in a communication skills role-play session asking students to evaluate their satisfaction with the session .


Data were analysed in SPSS @ .


One hundred and ninety eight students out of @ ( @ % ) responded .


Students were highly satisfied with the teaching session with no difference in satisfaction scores found between those sessions taught by peers , clinical and non-clinical staff members .


@ ( @ % ) considered the session useful and @ ( @ % ) strongly agreed tutors facilitated their development .


There was no significant difference in satisfaction scores based on tutor background .


Satisfaction is as high when tutored by peer-teachers compared to clinicians or non-clinical staff .


Constructive feedback is welcomed from a range of personnel .


Final-year students could play an increasing role in the teaching of pre-clinical medical students .


The immunogenicity , reactogenicity , and safety of the @-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine ( PHiD-CV ) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia , where PHiD-CV has been licensed .


In the primary vaccination phase , @ infants from Singapore and @ infants from Malaysia were randomised to receive the Phase III Clinical ( Clin ) or the Commercial ( Com ) lot of PHiD-CV at @ , @ , and @ months of age .


In the booster vaccination phase , @ toddlers from Singapore received one dose of the PHiD-CV Commercial lot at @-@ months of age .


Immune responses to pneumococcal polysaccharides were measured using @F-inhibition enzyme-linked immunosorbent assay ( ELISA ) and functional opsonophagocytic activity ( OPA ) assay and to protein D , using ELISA .


Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration ( GMC ) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype , @ % and @ % of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations @ g/mL and OPA titres @ , in the Clin and Com groups , respectively .


For each vaccine pneumococcal serotype , @ % and @ % of toddlers from Singapore had pre - and post-booster antibody concentrations @ g/mL , in the Clin and Com groups , respectively .


All children , except one , had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic .


The incidence of each grade @ solicited symptom was @ % in both study phases .


No serious adverse events considered causally related to vaccination were reported throughout the study .


PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT@ and NCT@ .


Recent trials of fish oil for the prevention of atrial fibrillation ( AF ) recurrence have provided mixed results .


Notable uncertainties in the existing evidence base include the roles of high-dose fish oil , inflammation , and oxidative stress in patients with paroxysmal or persistent AF not receiving conventional antiarrhythmic ( AA ) therapy .


The aim of this study was to evaluate the influence of high-dose fish oil on AF recurrence , inflammation , and oxidative stress parameters .


We performed a double-blind , randomized , placebo-controlled , parallel-arm study in @ patients with symptomatic paroxysmal or persistent AF within @ months of enrollment .


Patients were randomized to fish oil ( @ g/day ) or placebo and followed , on average , for @ @ days .


The primary endpoint was time to first symptomatic or asymptomatic AF recurrence lasting > @ s. Secondary endpoints were high-sensitivity C-reactive protein ( hs-CRP ) and myeloperoxidase ( MPO ) .


The primary endpoint occurred in @ % of patients in the fish oil arm and @ % of patients in the placebo arm ( hazard ratio : @ ; @ % confidence interval : @ to @ ; p = @ ) .


hs-CRP and MPO were within normal limits at baseline and decreased to a similar degree at @ months ( hs-CRP , @ % vs.-@ % ; MPO,-@ % vs.-@ % for fish oil vs. placebo , respectively ; p value for interaction = NS ) .


High-dose fish oil does not reduce AF recurrence in patients with a history of AF not receiving conventional AA therapy .


Furthermore , fish oil does not reduce inflammation or oxidative stress markers in this population , which may explain its lack of efficacy .


( Multi-center Study to Evaluate the Effect of N-@ Fatty Acids -LSB- OMEGA-@ -RSB- on Arrhythmia Recurrence in Atrial Fibrillation -LSB- AFFORD -RSB- ; NCT@ ) .


In patients with ulnar neuropathy at the elbow ( UNE ) , short-segment nerve conduction studies ( NCS ) are rarely performed due to unclear reference values .


We excluded controls with subclinical UNE , calculated normative values , and tested them in UNE patients .


Clinical examination , ultrasonography ( US ) , and @-cm short-segment ulnar motor NCS across the elbow were performed in @ controls and @ UNE patients .


In controls , subclinical UNE was diagnosed if at least @ studies were outside the reference limits in the same @-cm segment .


Exclusion of controls with subclinical UNE produced less stringent normative values ( @-cm conduction velocity : @ to @ m/s ; US cross-sectional area : @ to @ mm@ ) , which raised diagnostic sensitivity ( short-segment NCS : @ % to @ % ; @-cm NCS : @ % to @ % , US : @ % to @ % ) .


We propose the use of our normative values in patients with clinically definite and probable UNE after exclusion of alternative diagnoses .


Adductor canal blocks have shown promise in reducing postoperative pain in total knee arthroplasty patients .


No randomized , controlled studies , however , evaluate the opioid-sparing benefits of a continuous @ % ropivacaine infusion at the adductor canal .


We hypothesized that a continuous adductor canal block would decrease postoperative opioid consumption .


Eighty subjects presenting for primary unilateral total knee arthroplasty were randomized to receive either a continuous ultrasound-guided adductor canal block with @ % ropivacaine or a sham catheter .


All subjects received a preoperative single-injection femoral nerve block with spinal anesthesia as is standard of care at our institution .


Cumulative IV morphine consumption @ hours after surgery was evaluated with analysis of covariance , adjusted for baseline characteristics .


Secondary outcomes included resting pain scores ( numeric rating scale ) , peak pain scores during physical therapy on postoperative days @ and @ , quadriceps maximum voluntary isometric contraction , distance ambulated during physical therapy , postoperative nausea and vomiting , and satisfaction with analgesia .


Eighty subjects were randomized , and @ completed the study per-protocol .


The least-square mean difference in cumulative morphine consumption over @ hours ( block-sham ) was -- @ mg ( @ % confidence interval , -@ to -@ , P = @ ) .


Total morphine use between @ and @ hours ( after predicted femoral nerve block resolution ) also differed by least-square mean -@ mg ( @ % confidence interval , : -@ to -@ , P = @ ) .


Intention-to-treat analysis was similar to the per-protocol results .


Functional outcomes revealed subjects in the adductor canal catheter group had better quadriceps strength ( P = @ ) and further distance ambulated ( P = @ ) on postoperative day @ .


A continuous adductor canal block for total knee arthroplasty reduces opioid consumption compared with that of placebo in the first @ hours after surgery .


Other outcomes including quadriceps strength , distance ambulated , and pain scores all show benefit from an adductor canal catheter after total knee arthroplasty but require further study before being interpreted as conclusive .


To determine the effect of Tamsulosin , as adjunctive medical therapy after Extracorporeal Shock Wave Lithotripsy for renal stones on rate of stone clearance , clearance time , pain intensity during stone clearance , steinstrasse formation and auxiliary surgical intervention required .


A prospective randomized controlled study was carried out in @ patients who undeiwent ESWL for renal stones of @-@ @ cm .


They were randomized into study and control group in which Tamsulosin @ mg/day was given in former as an adjunctive medical therapy .


All patients underwent ESWL every @ weeks until complete stone clearance for @ weeks .


The parameters assessed were stone clearance , clearance time , pain intensity and effect on steinstrasse .


Of the @ patients @ were in each group .


The stone clearance rate was greater in study than in control group , @ ( @ % ) vs. @ ( @ % ) respectively , ( p < @ ) .


The mean stone clearance time was observed earlier in study group as compared to control group with significant statistical difference in stone size between @-@ .


Scm.The mean intensity of pain patients experienced according to Visual analogue scale ( VAS ) was significantly less in study group ( p < @ ) .


The rate of steinstrasse formation was observed to be higher in control than in study group @ ( @ % ) vs @ ( @ % ) respectively ( p < @ ) , while its spontaneous clearance was higher in study group than in control group @ % vs @ % ( p < @ ) .


Tamsulosin significantly increases stone clearance after shock wave lithotripsy for renal stones .


It also appeared to facilitate earlier stone clearance , reduces severity of pain , reduces the incidence of steinstrasse formation and tends to facilitate its spontaneous clearance .


Dyspnea is considered as one of the most frequent and distressing symptoms in patients with advanced cancer , and systemic administration of morphine has been reported to have beneficial effect on this complaint .


The effect of red morphine drops ( RMD ) given orally and kept in the mouth as long as possible before swallowing to alleviate dyspnea was compared to the effect of morphine given subcutaneously ( SCM ) in a double-blind , double-dummy trial .


Twenty consecutive terminally ill patients with primary lung cancer or lung metastases admitted to Sankt Lukas Hospice were included in the study .


All patients had dyspnea at rest , and they received either @/@ of their @-hour morphine dose as RMD or @ percent of this dose as SCM .


Perceived breathlessness was evaluated on a Visual Analogue Scale ( VAS ) during a @ minutes observation time , and pulse rate , respiratory rate and oxygen saturation were assessed as well .


Compared to baseline both RMD and SCM showed a small , but statistical significant effect on VAS ( mean decrease of @ -LSB- RMD -RSB- and @ -LSB- SCM -RSB- ) and pulse rate ( mean decrease of @ per minute -LSB- RMD -RSB- and @ per minute -LSB- SCM -RSB- ) , the effect being significantly larger after SCM .


The study confirms the beneficial effect of morphine on dyspnea in terminally ill patients , and we conclude that RMD is an attractive alternative to injected morphine , when self-administration is preferable .


Rheumatoid arthritis ( RA ) treatment recommendations suggest target attainment within the first @ months of therapy , yet delayed clinical responses can occur .


This analysis assessed the longterm clinical , functional , and radiographic outcomes associated with delayed responses to methotrexate ( MTX ) monotherapy or to the combination of adalimumab ( ADA ) + MTX .


In this posthoc analysis , patients with early RA who received MTX monotherapy or ADA + MTX in the PREMIER study were categorized based on clinical responses at @ and @ months -LSB- American College of Rheumatology response , @-joint Disease Activity Score ( DAS@ ) - C-reactive protein ( CRP ) improvement and targets -RSB- .


`` Month @ '' responders met the clinical measure at both months @ and @ , and `` Month @ '' responders met the clinical measure only at Month @ .


The odds of achieving longterm outcomes -LSB- remission ( DAS@-CRP < @ ) , normal function ( Health Assessment Questionnaire-Disability Index < @ ) , or rapid radiographic progression ( modified total Sharp score > @ U/yr ) -RSB- were modeled using logistic regression , including treatment , response , and interaction .


A delayed or low-level response was associated with poorer longterm outcomes .


Generally , MTX Month @ responders demonstrated worse clinical , functional , and radiographic outcomes than Month @ MTX and Month @ or @ ADA + MTX responders .


Although similar longterm benefit was observed for ADA + MTX responders , delayed ( Month @ ) responders exhibited downward trends in clinical , functional , and radiographic outcomes that were comparable with those experienced by Month @ MTX responders .


Response speed and magnitude predict longterm outcomes in patients with early RA treated with MTX or ADA + MTX .


MTX-treated patients failing to demonstrate a Month @ clinical response have less-favorable outcomes than other groups , while outcomes in ADA + MTX Month @ and Month @ responders tended to be comparable .


Perioral dermatitis ( POD ) is a common skin disease , and extending the range of treatments available for this condition is important .


To evaluate the safety , efficacy and tolerability of praziquantel @ % ointment as monotherapy .


This was a single-centre , randomized , single-blind , vehicle-controlled pilot study in adult patients ( n = @ ) with @weeks of treatment and @weeks of follow-up .


Efficacy was assessed clinically using the Investigator 's Global Assessment ( IGA ) and the Perioral Dermatitis Severity Index ( PODSI ) .


Quality of life ( QOL ) was determined by the Dermatology Quality of Life Index ( DLQI ) .


PODSI was significantly lower in the praziquantel group than in the placebo ( vehicle ) group , both during treatment and period .


Mean IGA score showed a statistically significant therapeutic advantage of praziquantel over placebo at week @ ( P < @ ) .


The praziquantel group experienced a greater improvement in mean DLQI .


No serious treatment-related adverse events occurred in either group .


Praziquantel ointment @ % effectively improves POD symptoms and QOL .


The aim of this study was to determine whether an interactive computer program could improve patient knowledge regarding genetic screening and diagnostic concepts .


In this randomized trial , women @-@weeks ' gestation were assigned to standard care with provider-based counseling or to augmented counseling with an interactive computer program .


The computer-based tool conveyed information about genetic testing options .


Women were administered a @-item test of content knowledge immediately and @-@weeks after exposure .


Test scores were compared between groups at both points using T-tests .


A total of @ women were randomized equally between groups .


Groups were similar with regard to demographic characteristics .


Women randomized to the interactive tool correctly answered a significantly greater proportion of questions than those who received standard counseling ( @ % @ % vs. @ % @ % , p < @ ) on the immediate questionnaire .


One hundred and twenty-three ( @ % ) participants participated in the follow-up test .


Women randomized to the tool continued to correctly answer a significantly greater proportion of questions ( @ % @ % vs. @ % @ % , p = @ ) .


Education , health literacy , electronic health literacy , and other discussions with providers were not associated with a differential benefit from the educational intervention .


A patient-directed interactive computer program may help providers to convey relevant information about genetic screening and diagnostic concepts .


To assess the safety and efficacy of antibiotics treatment for suspected acute uncomplicated appendicitis and to monitor the long term follow-up of non-operated patients .


Right lower quadrant abdominal pain is a common cause of emergency department admission .


The natural history of acute appendicitis nonoperatively treated with antibiotics remains unclear .


In @ , a total of @ patients -LSB- mean AIR ( Appendicitis Inflammatory Response ) score = @ and mean Alvarado score = @ -RSB- with suspected appendicitis were enrolled and underwent nonoperative management ( NOM ) with amoxicillin/clavulanate .


The follow-up period was @ years .


Short-term ( @ days ) NOM failure rate was @ % .


All patients with initial failures were operated within @ days .


At @ days , no recurrences were recorded .


After @ years , the overall recurrence rate was @ % ( @/@ ) ; @ of @ patients were successfully treated with further cycle of amoxicillin/clavulanate .


No major side effects occurred .


Abdominal pain assessed by the Numeric Rating Scale and the visual analog scale ; median Numeric Rating Scale score was @ at @ days and @ after @ days .


Mean length of stay of nonoperatively managed patients was @ days , and mean sick leave period was @ days .


Long-term efficacy of NOM treatment was @ % ( @ patients recurrence free and @ patients with recurrence nonoperatively managed ) .


None of the single factors forming the Alvarado or AIR score were independent predictors of failure of NOM or long-term recurrence .


Alvarado and AIR scores were the only independent predictive factors of NOM failure after multivariate analysis , but both did not correlate with recurrences .


Overall costs of NOM and antibiotics were & OV@ ; @ per patient .


Antibiotics for suspected acute appendicitis are safe and effective and may avoid unnecessary appendectomy , reducing operation rate , surgical risks , and overall costs .


After @ years of follow-up , recurrences of nonoperatively treated right lower quadrant abdominal pain are less than @ % and may be safely and effectively treated with further antibiotics .


Evidence is accumulating , predominantly among clinical trials in adults , that yoga improves blood pressure ( BP ) control , with downregulation of the hypothalamic-pituitary-adrenal ( HPA ) axis and the sympathetic nervous system ( SNS ) projected as underlying mechanisms .


This pilot study assessed whether Hatha yoga has the potential to reduce BP among youth and whether dampening of the SNS and/or HPA activity is a likely pathway of change .


Thirty-one seventh graders were randomly assigned to a Hatha yoga program ( HYP ) or attention control ( AC ) music or art class .


Baseline and @-month evaluations included resting BP ; overnight urine samples ; and saliva collected at bedtime , upon awakening , and at @ and @ minutes after awakening for - amylase and cortisol assays .


Twenty-eight ( @ in the HYP group and @ in the AC group ) students were assessed both before and after the intervention .


BP changes from pre - to post-intervention were -@ / -@ mmHg for the HYP group and -@ / -@ mmHg for the AC group ( p = @ and @ , respectively ) .


Changes in systolic BP ( SBP ) / diastolic BP ( DBP ) for the prehypertensive ( @th-@th percentiles for SBP ) subgroup analyses were -@ / -@ mmHg for the HYP group ( n = @ ) versus @ / @ mmHg for the AC group ( n = @ ) ( p for SBP = @ ; p for DBP = @ ) .


Although no statistically significant group differences were observed with changes in SNS or HPA awakening curves ( area under curve for - amylase and cortisol , respectively ) , a small to moderate effect size was seen favoring a reduction of - amylase activation for the HYP group ( Cohen d = @ ; prehypertensive d = @ ) .


A school-based Hatha yoga program demonstrated potential to decrease resting BP , particularly among prehypertensive youth .


Reduced SNS drive may be an underlying neurohormonal pathway beneficially affected by the program .


A large-scale efficacy/effectiveness randomized clinical trial is warranted .


To ensure that developing countries have the option to produce inactivated poliovirus vaccine ( IPV ) , the Global Polio Eradication Initiative has promoted the development of an IPV using Sabin poliovirus strains ( Sabin IPV ) .


This trial assessed the reactogenicity and immunogenicity of Sabin IPV and adjuvanted Sabin IPV in healthy adults in Cuba .


This is a randomized , controlled phase I trial , enrolling @ healthy ( previously vaccinated ) male human volunteers , aged @-@ years to receive one dose of either Sabin IPV ( @:@:@ DU/dose ) , adjuvanted Sabin IPV ( @:@:@ DU/dose ) , or conventional Salk IPV ( @:@:@ DU/dose ) .


The primary endpoint for reactogenicity relied on monitoring of adverse events .


The secondary endpoint measured boosting immune responses ( i.e. seroconversion or @-fold rise ) of poliovirus antibody , assessed by neutralization assays .


Sixty subjects fulfilled the study requirements .


No serious adverse events reported were attributed to trial interventions during the @-month follow-up period .


Twenty-eight days after vaccination , boosting immune responses against poliovirus types @-@ were between @ % and @ % in all vaccination groups .


There was a more than @-fold increase in median antibody titers between pre - and post-vaccination titers in all vaccination groups .


Both Sabin IPV and adjuvanted Sabin IPV were well tolerated and immunogenic against all poliovirus serotypes .


This result suggests that the aluminum adjuvant may allow a @ % ( or higher ) dose reduction .


Objectives of this ancillary analysis of a prospective , prevention study among Asian Indians with impaired glucose tolerance ( IGT ) were a ) to quantify the reduction in incident diabetes at @ months in participants who achieved normal glucose tolerance ( NGT ) at @ months ( NGT-@ m ) compared with the other participants , b ) the factors influencing the reversal to NGT at the end of the study at @ months ( NGT-@ m ) , and c ) to assess changes in cardiometabolic risk factors in different categories of dysglycemia at @ months .


Data from a @-year primary prevention trial were used .


Effect of reversion to NGT-@ m on incidence of type @ diabetes mellitus ( T@DM ) was analyzed using the Cox proportional hazards model .


Predictive variables for reversal to NGT were identified using multiple logistic regression analysis .


Changes in cardiometabolic risk factors were estimated according to the final glycemic status using fixed-effect , mixed-linear regression modeling .


The risk of T@DM in @ years was lower by @ % in NGT-@ m group ( hazard ratio @ -LSB- @ % CI @-@ @ -RSB- ) .


Predictive variables for reversal to NGT-@ m were good baseline - cell function ( odds ratio -LSB- OR -RSB- @ -LSB- @ % CI @-@ @ -RSB- ) and its further improvement ( OR @ -LSB- @ % CI @-@ @ -RSB- ) , and NGT-@ m ( OR @ -LSB- @ % CI @-@ @ -RSB- ) .


BMI decreased in those who reverted to NGT .


Deterioration to T@DM was associated with an increase in the levels of cardiometabolic risk factors .


Early reversion to NGT by lifestyle intervention in prediabetic men was associated with a significant reduction in subsequent incidence of diabetes .


Good baseline - cell function and its further improvement and NGT-@ m were associated with reversion to NGT-@ months .


Reversion to NGT was associated with modest improvements , whereas conversion to T@DM was associated with significant worsening of the cardiometabolic risk profile .


This one-year study investigated whether the Manitoba Provincial Health Contact program for congestive heart failure ( CHF ) is a cost-effective intervention relative to the standard treatment .


Individual patient-level , randomized clinical trial of cost-effective model using data from the Health Research Data Repository at the Manitoba Centre for Health Policy , University of Manitoba .


A total of @ patients aged @ and over with a diagnosis of CHF levels II to IV were recruited from Winnipeg and Central Manitoba and randomized into three treatment groups : one receiving standard care , a second receiving Health Lines ( HL ) intervention and a third receiving Health Lines intervention plus in-house monitoring ( HLM ) .


A cost-effectiveness study was conducted in which outcomes were measured in terms of QALYs derived from the SF-@ and costs using @ Canadian dollars .


Costs included intervention and healthcare utilization .


Bootstrap-resampled incremental cost-effectiveness ratios were computed to take into account the uncertainty related to small sample size .


The total per-patient mean costs ( including intervention cost ) were not significantly different between study groups .


Both interventions ( HL and HLM ) cost less and are more effective than standard care , with HL able to produce an additional QALY relative to HLM for $ @,@ .


The sensitivity analysis revealed that there is an @ % probability that HL is cost-effective if decision-makers are willing to pay $ @,@ .


Findings demonstrate that the HL intervention from the Manitoba Provincial Health Contact program for CHF is an optimal intervention strategy for CHF management compared to standard care and HLM .


Potential interactions between vaccines may compromise the immunogenicity and/or safety of individual vaccines so must be assessed before concomitant administration is recommended .


In this study , the immunogenicity and safety of travel vaccines against Japanese encephalitis ( JEV ) and rabies ( PCECV ) administered together with or without a quadrivalent meningococcal glycoconjugate ACWY-CRM vaccine were evaluated ( NCT@ ) .


Healthy adults aged @ to @ years were randomized to one of four vaccine regimens : JEV + PCECV + MenACWY-CRM , JEV + PCECV , PCECV or MenACWY-CRM .


Immunogenicity at baseline and @ days post-complete vaccination was assessed by serum bactericidal assay using human complement or neutralization tests .


Adverse events ( AEs ) were collected throughout the study period .


JEV + PCECV + MenACWY-CRM was non-inferior to JEV + PCECV .


Post-vaccination seroprotective neutralizing titers or concentrations were achieved in @-@ % ( JE ) and @ % ( rabies ) of subjects across the vaccine groups .


Antibody responses to vaccine meningococcal serogroups were in the same range for MenACWY-CRM and JEV + PCECV + MenACWY-CRM .


Rates of reporting of AEs were similar for JEV + PCECV and JEV + PCECV + MenACWY-CRM .


MenACWY-CRM was administered with an inactivated adjuvanted JE and a purified chick embryo cell-culture rabies vaccine without compromising immunogenicity or safety of the individual vaccines .


These data provide evidence that MenACWY-CRM could be effectively incorporated into travel vaccination programs .


Individual variation in response and duration of anti-vascular endothelial growth factor ( VEGF ) therapy is seen among patients with neovascular age-related macular degeneration .


Identification of genetic markers that affect clinical response may result in optimization of anti-VEGF therapy .


To evaluate the pharmacogenetic relationship between genotypes of single-nucleotide polymorphisms ( SNPs ) in the VEGF signaling pathway and response to treatment with ranibizumab or bevacizumab for neovascular age-related macular degeneration .


In total , @ of @ patients ( @ % ) participating in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) at @ CATT clinical centers .


Each patient was genotyped for @ SNPs in VEGFA ( rs@ , rs@ , rs@ , rs@ , rs@ , rs@ , and rs@ ) and @ SNP in VEGFR@ ( rs@ ) using TaqMan SNP genotyping assays .


Genotypic frequencies were compared with clinical measures of response to therapy at @ year , including the mean visual acuity , mean change in visual acuity , at least a @-letter increase , retinal thickness , mean change in total foveal thickness , presence of fluid on optical coherence tomography , presence of leakage on fluorescein angiography , mean change in lesion size , and mean number of injections administered .


Differences in response by genotype were evaluated with tests of linear trend calculated from logistic regression models for categorical outcomes and linear regression models for continuous outcomes .


The method of controlling the false discovery rate was used to adjust for multiple comparisons .


For each of the measures of visual acuity evaluated , no association was observed with any of the genotypes or with the number of risk alleles .


Four VEGFA SNPs demonstrated an association with retinal thickness : rs@ ( P = @ ) , rs@ ( P = @ ) , rs@ ( P = @ ) , and rs@ ( P = @ ) .


However , adjusted P values for these associations were all statistically nonsignificant ( range , P = @ to P = @ ) .


Among the participants in @ as-needed groups , no association was found in the number of injections among the different genotypes or for the total number of risk alleles .


The effect of risk alleles on each clinical measure did not differ by treatment group , drug , or dosing regimen ( P > @ for all ) .


This study provides evidence that no pharmacogenetic associations exist between the studied VEGFA and VEGFR@ SNPs and response to anti-VEGF therapy .


Atrial fibrillation after cardiac surgery is associated with increases in the risk of complications , length of intensive care unit stay , and cost of care .


Beta blockers are effective for controlling myocardial ischemia and arrhythmia and suppressing inflammatory cytokines .


The purpose of this study was to examine the effect of administrating a short-acting beta-adrenoceptor antagonist , landiolol , on postoperative atrial fibrillation .


@ patients undergoing off-pump coronary artery bypass grafting were single-blindly assigned randomly to landiolol ( n = @ ) and non-landiolol ( control , n = @ ) groups .


In the landiolol group , the beta blocker was administered from the beginning of the operation until postoperative day @ .


The primary endpoint was the incidence of atrial fibrillation until postoperative day @ , and the secondary endpoints were the postoperative levels of troponin I , creatine kinase MB-isoenzyme , and C-reactive protein .


The incidence of atrial fibrillation was significantly lower in the landiolol group compared to the control group ( @/@ , @ % vs. @/@ , @ % , p = @ , logrank test ) .


Landiolol also significantly reduced the postoperative peak C-reactive protein level compared to the control group ( @ vs. @ mgL ( -@ ) , p = @ ) .


Low-dose continuous infusion of landiolol reduced the incidence of postoperative atrial fibrillation , and significantly suppressed inflammation .


Magnesium sulphate ( MgSO@ ) , NMDA receptor antagonist , is known to reduce perioperative requirement of anesthetics and analgesics .


However , no studies assessed the effect of MgSO@ on onset and recovery from spinal anesthesia .


A prospective , randomised , double blind study was designed to assess the effect of intravenous ( IV ) MgSO@ on onset and recovery from spinal anesthesia and post operative analgesic requirement following below umbilical surgery .


Sixty patients ( ASA class I & II ) were selected randomly and divided into two groups .


Patients were given either MgSO@ @ mg kg ( -@ ) in @ mL within @ min , followed by an infusion of MgSO@ @ mg kg ( -@ ) hr ( -@ ) IV in @mL ( MG group ) for @ hrs or normal saline in same volume and rate for @ hrs as used in MG group ( NS group ) .


After initiating the infusion , spinal anesthesia was given with @ % bupivacaine ( Hyperbaric ) @ mL at L@/@ or L@/@ space .


Time taken for sensory block at the level of T-@ and motor block ( modified Bromage Score-@ ) was noted .


Postoperatively , time taken for recovery from spinal anesthesia , pain score and requirement of postoperative analgesic in @ hours were observed and compared between the two groups .


The first rescue analgesia was required after @ + / - @ min in MG group and after @ + / - @ min in NS group with significant difference ( p < @ ) .


The morphine required over @ hours for analgesia was significantly less in MG group ( @ + / - @ mg ) as compared to NS group ( @ + / - @ mg ) ( p < @ ) .


Intravenous MgSO@ improves postoperative analgesia without affecting the onset and recovery from spinal anesthesia .


Sodium nitroprusside ( SNP ) is used to decrease arterial blood pressure ( BP ) during certain surgical procedures .


There are limited data regarding efficacy of BP control with SNP .


There are no data on patient and clinician factors that affect BP control .


We evaluated the dose-response relationship of SNP in infants and children undergoing major surgery and performed a quantitative assessment of BP control .


One hundred fifty-three subjects at @ sites received a blinded infusion followed by open-label SNP during operative procedures requiring controlled hypotension .


SNP was administered by continuous infusion and titrated to maintain BP control ( mean arterial BP -LSB- MAP -RSB- within @ % of clinician-defined target ) .


BP was recorded using an arterial catheter .


Statistical process control methodology was used to quantify BP control .


A multivariable model assessed the effects of patient and procedural factors .


BP was controlled an average @ % ( SD @ % ; @ % CI , @ % -@ % ) of the time .


Larger changes in infusion rate were associated with worse BP control ( @ % less control for @ gkgmin increase in average titration size , P = @ ) .


A larger difference between a patient 's baseline and target MAP predicted worse BP control ( @ % worse control per @-mm Hg increase in MAP difference , P = @ ) .


Both effects persisted in multivariable models .


SNP was effective in reducing BP .


However , BP was within the target range less than half of the time .


No clinician or patient factors were predictive of BP control , although @ inverse relationships were identified .


These relationships require additional study and may be best coupled with exposure-response modeling to propose improved dosing strategies when using SNP for controlled hypotension in the pediatric population .


Acamprosate has been available in the United States for treating alcohol use disorders ( AUDs ) for nearly a decade , yet few studies have examined its use within AUD treatment organizations .


In addition to describing dissemination and adoption of acamprosate , this study provides novel data regarding organizational processes that underlie its implementation within adopting programs .


Data were drawn from interviews with leaders of a nationally representative sample of @ organizations delivering AUD treatment .


Quantitative indicators of organizational characteristics , dissemination , adoption , and implementation of acamprosate , as well as qualitative measures of implementation processes , were measured during face-to-face interviews .


Only @ % ( n = @ ) of sampled organizations had adopted acamprosate for treating AUDs , and adoption was positively associated with accreditation , having a physician on staff , receiving information about acamprosate via pharmaceutical representatives , and learning about this medication from other treatment providers .


Within adopting programs , an average of @ % of AUD patients were currently receiving acamprosate .


Numerous implementation challenges were identified , including appropriate patient selection , patient reluctance to be prescribed acamprosate , suboptimal adherence , its costs , and limited counselor training .


The limited adoption and implementation of acamprosate likely limits the potential public health impact of this adjunct to AUD treatment .


Research integrating the perspectives of organizational leaders , medical professionals , and patients is needed to determine whether specific strategies can address the implementation challenges identified in the current study and increase use of acamprosate in specialty AUD treatment settings .


The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established .


This paper is a study protocol , describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence .


Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention , and the components of the intervention were structured in accordance with the cognitive-behavioural model .


The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery .


The study is a randomized clinical trial including @ patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis .


Patients were recruited in the period October @ to July @ , and the follow-up period is one year from date of surgery .


Patients are allocated on a @:@ ratio ( control : intervention ) to either treatment as usual ( control group ) , which implies surgery and the standard postoperative rehabilitation , or in addition to this , a patient education focusing on pain behaviour and pain coping ( intervention group ) .


It takes place in a hospital setting , and consists of six group-based sessions , managed by a multidisciplinary team of health professionals.The primary outcomes are disability ( Oswestry Disability Index ) and sick leave , while secondary outcomes include coping ( Coping Strategies Questionnaire ) , fear-avoidance belief ( Fear Avoidance Belief Questionnaire ) , pain ( Low Back Pain Rating Scale , pain index ) , mobility during hospitalization ( Cumulated Ambulation Score ) , generic health-related quality of life ( EQ-@D ) and resource use .


Outcomes are measured using self report questionnaires , medical records and national registers .


It is expected that the intervention can provide better functional outcome , less pain and earlier return to work after lumbar spinal fusion surgery .


By combining knowledge and evidence from different knowledge areas , the project aims to provide new knowledge that can create greater consistency in patient treatment .


We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbar spinal fusion .


Artemisinin-based combination therapies ( ACTs ) are recommended for the treatment of acute uncomplicated falciparum malaria in many malaria-endemic countries .


Despite the emergence of artemisinin resistance , few alternative non-ACTs , including atovaquone-proguanil , are currently available .


Plasmodium falciparum-infected Cameroonian children @ years old ( n = @ ) were randomly assigned to artesunate-amodiaquine , atovaquone-proguanil , or artesunate-atovaquone-proguanil treatment groups and followed for @ days , according to the standard World Health Organization protocol .


In vitro response to atovaquone and cytochrome b sequence of clinical isolates were determined .


Eight late failures and @ failures ( @ late and @ early failures ) were observed after artesunate-amodiaquine and atovaquone-proguanil therapies , respectively .


Most late failures were due to reinfections .


Artesunate-atovaquone-proguanil was not associated with any failure .


After correction by genotyping , per-protocol analysis showed no difference in the efficacy of @ drugs .


However , the proportion of atovaquone-proguanil-treated patients with positive smears on day @ was much higher ( @ % ; P < @ ) than that of the artesunate-amodiaquine ( @ % ) and artesunate-atovaquone-proguanil ( @ % ) groups .


In vitro response and cytochrome b sequence did not indicate atovaquone resistance .


Atovaquone-proguanil was characterized by a slow blood schizontocidal action and resulted in early treatment failure in a few patients .


Artesunate-atovaquone-proguanil was a highly effective alternative treatment .


There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen .


The main aim of the study was to ascertain HPV-@ / @ vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-vaccine HPV types , by number of doses received .


Summary data from the Costa Rica Vaccine Trial ( CVT ; NCT@ ) and ~ the PATRICIA trial ( NCT@ ) , two phase @ , double-blind , randomised controlled clinical trials of the HPV-@ / @ AS@-adjuvanted vaccine in young women , were combined in a post-hoc analysis ( GlaxoSmithKline -LSB- GSK -RSB- e-track number @ ) to investigate the efficacy of fewer than three doses of the HPV-@ / @ vaccine after @ years of follow-up .


Women were randomly assigned to receive three doses of the HPV-@ / @ vaccine or to a control vaccine ; yet , some received fewer doses .


After exclusion of women with less than @ months of follow-up or those who were HPV-@ / @ DNA-positive at enrolment ( for the HPV-@ / @ endpoint ) , we calculated vaccine efficacy against one-time detection of incident HPV infections after three , two , and one dose ( s ) .


The primary study endpoint was one-time detection of first incident HPV-@ / @ infections accumulated during the follow-up phase .


We assessed vaccine efficacy against incident HPV-@ / @ infection in the modified total vaccinated cohort ( @ received three doses , @ two doses , @ one dose ) .


Vaccine efficacy against incident HPV-@ / @ infections for three doses was @ % ( @ % CI @-@ ) , two doses was @ % ( @-@ ) , and one dose was @ % ( @-@ ) .


Vaccine efficacy against incident HPV-@ / @/@ infections for three doses was @ % ( @-@ ) , two doses was @ % ( @-@ ) , and one dose was @ % ( -@ to @ ) .


Vaccine efficacy against incident HPV-@ / @ infection for two-dose women who received their second dose at @ month was @ % ( @-@ ) and @ % ( @-@ ) for those who received the second dose at @ months ( CVT data only ) .


Vaccine efficacy against HPV-@ / @/@ for two-dose women who received their second dose at @ months ( @ % , @-@ ; CVT data only ) , but not those receiving it at one month ( @ % , -@ to @ ) , was similar to the three-dose group .


@ years after vaccination of women aged @-@ years , one and two doses of the HPV-@ / @ vaccine seem to protect against cervical HPV-@ / @ infections , similar to the protection provided by the three-dose schedule .


Two doses separated by @ months additionally provided some cross-protection .


These data argue for a direct assessment of one-dose efficacy of the HPV-@ / @ vaccine .


In postmenopausal women , yearly intravenous zoledronate ( ZOL ) compared to placebo ( PLB ) significantly increased bone mineral density ( BMD ) at lumbar spine ( LS ) , femoral neck ( FN ) , and total hip ( TH ) and decreased fracture risk .


The effects of ZOL on BMD at the tibial epiphysis ( T-EPI ) and diaphysis ( T-DIA ) are unknown .


A randomized controlled ancillary study of the HORIZON trial was conducted at the Department of Osteoporosis of the University Hospital of Berne , Switzerland .


Women with @ follow-up DXA measurement who had received @ dose of either ZOL ( n = @ ) or PLB ( n = @ ) were included .


BMD was measured at LS , FN , TH , T-EPI , and T-DIA at baseline , @ , @ , @ , and @ months .


Morphometric vertebral fractures were assessed .


Incident clinical fractures were recorded as adverse events .


Baseline characteristics were comparable with those in HORIZON and between groups .


After @ months , BMD was significantly higher in women treated with ZOL vs. PLB at LS , FN , TH , and T-EPI ( +@ % , +@ % , +@ % , and +@ % , respectively , p < @ for all ) but not T-DIA ( +@ % ) .


The number of patients with @ incident non-vertebral or morphometric fracture did not differ between groups ( @ ZOL/@ PLB ) .


Mean changes in BMD did not differ between groups with and without incident fracture , except that women with an incident non-vertebral fracture had significantly higher bone loss at predominantly cortical T-DIA ( p = @ ) .


ZOL was significantly superior to PLB at T-EPI but not at T-DIA .


Women with an incident non-vertebral fracture experienced bone loss at T-DIA .


To compare the efficacy on vertebrobasilar insufficiency ( VBI ) between auricular acupuncture therapy and oral administration of medicine .


Sixty patients of VBI were randomized into an auricular acupuncture therapy group and a medicine group , @ cases in each one .


In the auricular acupuncture group , acupuncture was applied bilaterally to gan ( CO@ ) and jiejie ( HX@ ) on the ears and needles were retained for @ min .


After needle withdrawal , the vaccariae semen were fixed with plaster at naogan ( AT@ , @i ) , zhen ( AT@ ) , jing ( AH@ ) , shen ( CO@ ) and pi ( CO@ ) on the ears .


In the medicine group , flunarizine hydrochloride capsules ( Sibelium ) , @mg were prescribed for oral administration , once every night .


The treatment lasted continuously for @ weeks ( @ days ) in the two groups .


In @ weeks , the clinical efficacy was assessed and the transcranial doppler ( TCD ) examination was performed .


After treatment , the symptom scores were all apparently reduced in the patients of the two groups ( P < @ , P < @ ) .


Compared with the medicine group , the reduced score was much more obvious in the auricular acupuncture group ( P < @ ) , indicating the significant difference .


After treatment , with TCD examination , the blood velocity was increased to different degrees in the patients of low velocity type in the auricular acupuncture group and the medicine group ; that was reduced to different degrees in the patients of high velocity type in the auricular acupuncture group and the medicine group .


All of them were different significantly as compared with those before treatment ( all P < @ ) .


But the difference was not significant between the two groups ( both P > @ ) .


In comparison of clinical efficacy between the two groups , the effective rate was @ % ( @/@ ) in the acupuncture group and better than @ % ( @/@ ) in the medicine group , indicating the significant difference in comparison ( P < @ ) .


The auricular acupuncture therapy achieves the definite efficacy on VBI and the efficacy is better than flunarizine hydrochloride capsules .


Post licensure studies have identified an increased risk of intussusception following vaccination with currently licensed rotavirus vaccines , raising safety concerns generic to all rotavirus vaccines .


We describe the surveillance for intussusception in a phase III clinical trial with an oral monovalent rotavirus vaccine developed from the neonatal @E strain .


Using broad screening criteria and active surveillance , the incidence of intussusception between @ weeks and @ years of age was measured in @ children who received three doses of vaccine and @ children who received a placebo in the clinical trial .


Possible intussusceptions were evaluated with a screening ultrasonogram .


An independent intussusception case adjudication committee reviewed all intussusceptions and graded them on Brighton Collaboration criteria for diagnostic certainty .


We identified twenty-three intussusceptions on ultrasound from @ evaluated sentinel events .


Eleven were of level @ diagnostic certainty as determined by the independent intussusception case adjudication committee .


None required surgical intervention , and the earliest identified intussusception was at @ days following the third dose in a placebo recipient .


Among vaccine recipients the first event of intussusception occurred @ days after the third dose .


The incidence of ultrasound-diagnosed intussusception was @/@ ,@ child-years ( @ % CI , @ , @ ) among those receiving the vaccine and @/@ ,@ child-years ( @ % CI , @ , @ ) among those receiving the placebo .


The incidence rate of confirmed intussusception among vaccine recipients was @/@ ,@ child-years ( @ % CI , @ , @ ) and @/@ ,@ child-years ( @ % CI , @ , @ ) among those receiving the placebo .


In this licensure study , @ cases of intussusception were identified through an active surveillance system , but there was no temporal association with rotavirus vaccination .


The use of active surveillance with broad criteria intended for ensuring safety of children participating in a trial , identified several transient intussusceptions that were of doubtful clinical significance .


Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions .


A hyaluronic acid/carboxymethylcellulose ( HA/CMC ) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery .


An HA/CMC powder formulation was developed for application during laparoscopic procedures .


This was an exploratory , prospective , randomised , single-blind , parallel-group , Phase IIIb , multicentre study conducted at @ hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery .


Subjects @ years of age who were scheduled for colorectal laparoscopy ( Mangram contamination class IIII ) within @ weeks of selection were eligible , regardless of aetiology .


Participants were randomised @:@ to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list .


Patients assigned to HA/CMC powder received a single application of @ to @ g on adhesion-prone areas .


In the no adhesion barrier group , no adhesion barrier or placebo was applied .


The primary safety assessments were the incidence of adverse events , serious adverse events , and surgical site infections ( SSIs ) for @ days following surgery .


Between-group comparisons were made using Fisher 's exact test .


Of those randomised to the HA/CMC powder ( n = @ ) or no adhesion barrier ( n = @ ) groups , one patient in each group discontinued prior to the study end ( one death in each group ) .


Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group ( @ % vs. @ % ; P < @ ) , as were serious adverse events ( @ % vs. @ % ; P < @ ) .


There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs ( @ % vs. @ % ; P = @ ) and serious SSIs ( @ % vs. @ % ; P = @ ) , or in the most frequent serious SSIs of pelvic abscess ( @ % and @ % ; significance not tested ) , anastomotic fistula ( @ % and @ % ) , and peritonitis ( @ % and @ % ) .


This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection .


We conducted this study to assess the immunologic effect of daily @ mg zinc supplementation for @ weeks in HIV-infected children older than @ months receiving highly active antiretroviral therapy ( ART ) .


Fifty-two HIV-infected children older than @ months in whom ART was initiated were randomized to receive either @ mg of zinc or placebo for a period of @ weeks .


Children underwent clinical examination , anthropometry , and laboratory evaluations : CD@ % and count , viral load , and serum zinc level at baseline , @ weeks , and @ weeks .


The primary outcome evaluated was CD@ % value at the end of @ and @ weeks of study intervention in the enrolled children .


Of @ children enrolled , @ completed the study .


The median CD@ % value rose from @ % to @ % at @ weeks and to @ % at @ weeks in the zinc group , whereas in the placebo group , the value rose from @ % to @ % at @ weeks and to @ % at @ weeks ( P = @ for comparison between the zinc and the placebo group at @ wk and P = @ for comparison at @ wk ) .


The median ( interquartile range ) log reductions in the viral load at @ weeks in the @ arms were similar at @ ( P = @ ) and @ weeks ( P = @ ) .


Supplementation of @ mg zinc daily for @ weeks did not have any statistically significant effect on the increase in CD@ % , decrease in viral load , anthropometric indices , and morbidity profile in HIV-infected children started on ART .


To investigate the effects of @-month treatment of medroxyprogesterone acetate ( MPA ) and Diane-@ on the clinical and biochemical features of hyperandrogenism and quality of life of adolescent girls with polycystic ovarian syndrome ( PCOS ) .


A prospective , randomized , cross-over study .


An accredited pediatric and adolescent gynecology clinic of a university-affiliated tertiary hospital .


@ adolescents girls aged @ to @ years old with PCOS were recruited from July @ to July @ .


Girls were randomized into @ groups .


Group @ received oral MPA for @ months , followed by a washout period of @ months , and then Diane-@ for another @ months .


Group @ received the same combination but in the reverse order .


Clinical and biochemical features of hyperandrogenism and quality of life were assessed .


There was no significant difference between the @ groups at baseline .


No significant difference was found in the clinical and biochemical parameters of hyperandrogenism before and after treatment with MPA .


Significant reduction of the acne score , LH/FSH ratio , and testosterone level was seen after taking Diane-@ .


Hirsutism was also improved but it did not reach statistical significant .


When comparing post-MPA and post-Diane-@ , the post-Diane-@ group had significantly improved acne score and LH/FSH ratio .


No significant difference was found on quality of life between both groups after treatment .


Diane-@ may be a more suitable treatment option in adolescent girls diagnosed with PCOS when compared to MPA .


The purpose of this work was to evaluate the effect of loteprednol etabonate ( LE ) before the initiation of topical cyclosporine A ( tCsA ) therapy in patients with mild-to-moderate dry eye disease .


Prospective , multicenter randomized double-masked parallel group clinical study ( NCT@ ) .


Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA ( n = @ ) or artificial tears ( AT ) and tCsA ( n = @ ) .


Hundred and twelve patients completed the study ( LE : n = @ , AT : n = @ ) and are included in the data analysis .


Patients self-administered either LE or AT for @ weeks @ times per day , followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional @ weeks of treatment .


Primary outcome measures included the Ocular Surface Disease Index ( OSDI ) questionnaire , the Likert scale using standardized facial expressions , lissamine green staining , fluorescein staining , and the Schirmer test .


Additional measures included global self-assessment , and safety outcomes included slitlamp examination , intraocular pressure , and assessment of visual acuity .


Loteprednol etabonate pretreatment significantly reduced tCsA stinging ( P < @ ) .


Both groups showed significantly improved OSDI scores at the @ - , @ - , and @-day visits .


Loteprednol etabonate showed significantly more OSDI improvement than AT .


Both pretreatment strategies improved global self-assessment scores , Schirmer test , fluorescein staining , lissamine staining , and adjunctive AT use .


Loteprednol etabonate showed superior improvement in Schirmer test , fluorescein staining , and lissamine staining .


Intraocular pressure did not increase in either group .


Loteprednol etabonate induction therapy @ weeks before the initiation of long-term tCsA treatment for chronic dry eye disease provides more rapid relief of dry eye signs and symptoms with greater efficacy than tCsA and AT alone .


The prevalence of obesity among children and adolescents has been rapidly rising in Mainland China in recent decades , both in urban and rural areas .


There is an urgent need to develop effective interventions to prevent childhood obesity .


Limited rigid data regarding children and adolescent overweight prevention in China are available .


A national random controlled school-based obesity intervention program was developed in the mainland of China .


The study was designed as a national multi-centered cluster randomized controlled trial involving more than @,@ children and adolescents aged @-@ years from @ provinces in China .


In each center , about @-@ primary and secondary schools , with totally at least @ participants were randomly selected ( Primary : Secondary = @:@ ) .


All of the selected schools were randomly allocated to either intervention or control group ( Intervention : Control = @:@ ) .


The multi-components school-based and family-involved scheme was conducted within the intervention group for @month , while students in the control group followed their usual health practice .


The intervention consisted of four components : a ) Create supportive school and family environment , b ) Health lifestyles education and related compulsory physical activities , c ) Instruct and promote school physical education , d ) Self-monitor obesity related behaviors .


Four types of outcomes including anthropometric , behavioral , blood chemical and physical fitness were measured to assess the effectiveness of the intervention program .


This is the first and largest multi-centered school-based obesity intervention program with the consideration of geographical and social-demographic characteristics of the rapidly increased obesity prevalence of Chinese children and adolescent .


The intervention is based on Social Cognitive Theory and Social-Ecological Model of Health , and follows a stepwise approach guided by PRECEDE-PROCEED ( P-P ) Model and Intervention Map .


The results of and lesson learned from this study will help guide future school-based national childhood obesity prevention programs in Mainland China .


Our objective was to compare the effectiveness and safety of traditional Chinese moxibustion to that of sham moxibustion in patients with chronic knee osteoarthritis ( KOA ) pain .


We conducted a randomized placebo-controlled trial involving @ patients with KOA who met the inclusion criteria .


These patients randomly received either active moxibustion ( n = @ ) or sham moxibustion control ( n = @ ) at acupoints Dubi ( ST @ ) , extra-point Neixiyan ( EX-LE @ ) , and an Ashi ( tender ) point three times a week for @ weeks .


Effects were evaluated with Western Ontario and McMaster Universities ' Osteoarthritis Index ( WOMAC VA @ ) criteria at the end of the course of treatment and @ , @ , and @ weeks after the initial treatment .


The WOMAC pain scores showed greater improvement in the active treatment group than in control at weeks @ ( P = @ ) , @ ( P < @ ) , @ ( P = @ ) , and @ ( P = @ ) as did WOMAC physical function scores of the active treatment group at week @ ( P = @ ) , @ ( P = @ ) , and @ ( P < @ ) but not @ ( P = @ ) .


Patients and practitioners were blinded successfully , and no significant adverse effects were found during the trial .


A @-week course of moxibustion seems to relieve pain effectively and improve function in patients with KOA for up to @ weeks after the end of treatment .


Moxibustion treatment appears to be safe , and the usefulness of the novel moxa device was validated .


To compare the efficacy and safety of single ( tamsulosin ) and double dose ( tamsulosin + alfuzosin ) alpha-blocker therapy for treating catheterized patients with acute urinary retention ( AUR ) due to benign prostatic hyperplasia ( BPH ) .


Seventy patients with AUR due to BPH were catheterized and randomized into two groups : the single dose group ( @ mg tamsulosin , @ patients ) and the double dose group ( @ mg tamsulosin + @ mg alfuzosin , @ patients ) .


The catheter was removed after @ days , and the patients were put on trial without catheter ( TWOC ) .


Seventy males ( mean age , @ years ) were randomly assigned to receive double or single dose alpha-blocker ( @ patients per group ) .


The intent-to-treat population consisted of @ males .


Twenty-seven individuals in the double dose group and @ in the single dose group did not require re-catheterization on the day of the TWOC ( @ % and @ % , respectively ; P = @ ) .


Success using free-flow variables was also higher in the males who received double dose alpha-blocker compared with single dose therapy ( @ % vs. @ % ; P = @ ) .


TWOC was more successful in males treated with double dose alpha-blockers , and the subsequent need for re-catheterization was also reduced .


The side-effect profiles were similar in the single and double dose alpha-blocker groups and were consistent with the known pharmacology .


These results state that double dose alpha-blocker treatment can be recommended for treating males after catheterization for AUR , which may reduce the need for re-catheterization .


Vascular closure devices ( VCD ) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography .


However , clinical studies comparing VCD and manual compression have yielded mixed results , and large randomised clinical trials comparing the two strategies are missing .


Moreover , comparative efficacy studies between different VCD in routine clinical use are lacking .


The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression ( ISAR-CLOSURE ) trial is a prospective , randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis .


The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications .


Patients undergoing coronary angiography via the common femoral artery will be randomised in a @:@:@ fashion to receive FemoSeal VCD , EXOSEAL VCD or manual compression .


The primary endpoint is the incidence of the composite of arterial access-related complications ( haematoma @ cm , pseudoaneurysm , arteriovenous fistula , access-site-related bleeding , acute ipsilateral leg ischaemia , the need for vascular surgical/interventional treatment or documented local infection ) at @ days after randomisation .


According to power calculations based on non-inferiority hypothesis testing , enrolment of @,@ patients is planned .


The trial is registered at www.clinicaltrials.gov ( study identifier : NCT@ ) .


The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise .


The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications .


To investigate the effects of weight reduction on foot structure , gait , and dynamic plantar loading in obese adults .


In a @-month randomized-controlled trial , participants were randomized to receive either a weight loss intervention based on portion-controlled meals or a delayed-treatment control .


@ adults ( @ F , @ M ) with a mean SD age of @ @ years and a BMI of @ @ kg/m ( @ ) .


Arch Height Index ( AHI ) , Malleolar Valgus Index ( MVI ) , spatial and temporal gait parameters , plantar peak pressure ( PP ) and weight were measured at baseline , @ , and @ months .


The intervention group experienced significantly greater weight loss than did the control group ( @ @ kg versus @ @ kg , p = @ ) after @ months .


There were no differences between the groups in anatomical foot structure or gait .


However , the treatment group showed a significantly reduced PP than the control group beneath the lateral arch and the metatarsals @ ( all p values < @ ) at @ months .


The change in PP correlated significantly with the change in weight at the metatarsal @ ( r = @ , p = @ ) , metatarsal @ ( r = @ , p = @ ) and the medial arch ( r = @ , p < @ ) at @ months .


This was the first RCT designed to assess the effects of weight loss on foot structure , gait , and plantar loading in obese adults .


Even a modest weight loss significantly reduced the dynamic plantar loading in obese adults .


However , weight loss appeared to have no effects on foot structure and gait .


We sought to develop placental growth factor as a predictive pharmacodynamic biomarker for motesanib efficacy as first-line therapy in patients with advanced nonsquamous non-small-cell lung cancer .


Placental growth factor was evaluated at baseline and study week @ ( after @ weeks treatment ) in an exploratory analysis of data from a randomized phase @ study of motesanib @ mg once daily plus carboplatin/paclitaxel and in a prespecified analysis of data from a randomized , double-blind phase @ study of motesanib @ mg once daily plus carboplatin/paclitaxel vs placebo plus carboplatin/paclitaxel ( MONET@ ) .


Associations between fold-change from baseline in placental growth factor and overall survival were evaluated using Cox proportional hazards models .


In the phase @ study , serum placental growth factor increased from baseline a mean @-fold at study week @ .


Patients with @-fold change from baseline in placental growth factor ( n = @ ) had significantly longer overall survival than those with < @-fold change ( n = @ ; @ vs @ months ; hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


Consequently , placental growth factor was investigated as a pharmacodynamic biomarker in the phase @ MONET@ study .


There was no association between log-transformed placental growth factor fold-change from baseline to week @ ( continuous variable ) and overall survival ( hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


MONET@ did not meet its primary endpoint of overall survival .


Likewise , median overall survival was similar among patients with @-fold change in placental growth factor ( n = @ ) compared with < @-fold change ( n = @ ; @ vs @ months ; hazard ratio , @ ; @ % CI , @-@ @ , P = @ ) .


Our results illustrate the challenges of successfully translating phase @ biomarker results into phase @ studies .


The Epley particle repositioning maneuver ( PRM ) is an effective treatment for benign paroxysmal positional vertigo ( BPPV ) , the most common cause of peripheral vertigo in primary care settings .


The goal of this study was to determine whether the use of an iPhone application ( DizzyFIX ; Clearwater Clinical Ltd , Ottawa , Ontario , Canada ) by medical students had a significant impact on the performance of the PRM .


We recruited senior medical students who had previously been trained in the management of BPPV and asked them to perform the PRM on a healthy volunteer .


One half of the students used a real iPhone application , whereas the others used a sham application .


The PRM performance scores of the @ groups were compared .


iPhone application users scored significantly higher on their PRM performance compared with controls ( P < @ ) and performed the PRM significantly more slowly ( P < @ ) .


Senior medical students performed a more correct PRM when assisted by the iPhone application .


This application represents a significant improvement from standard medical school training using written instructions .


Family physicians could also use this iPhone application for the quick and effective treatment of BPPV .


Studies of zinc as an adjunct to treatment of severe pneumonia in children have shown mixed results , possibly because of poor information on zinc status and respiratory pathogens .


We evaluated the effect of zinc given with standard antimicrobial treatment on the duration of respiratory signs in children with severe pneumonia .


Zinc status and pathogens were assessed .


Children aged @-@ mo with severe pneumonia who were admitted to the main children 's hospital in Quito , Ecuador , were given standard antibiotics and randomly allocated to receive zinc supplements twice daily or a placebo .


Measurements included anthropometric variables , breastfeeding , hemoglobin , plasma zinc , and common bacteria/viral respiratory pathogens .


The primary outcome was time to resolution of respiratory signs .


The secondary outcome was treatment failure .


We enrolled @ children in each group .


There was no difference between groups in time to resolution of respiratory signs or treatment failure ; pathogens were not associated with outcomes .


Tachypnea and hypoxemia resolved faster in older children ( P = @ ) than in younger ones .


Higher basal zinc concentration ( P = @ ) and better height-for-age z score ( HAZ ) ( P = @ ) were associated with faster resolution of chest indrawing .


Better weight-for-height z score ( WHZ ) ( P = @ ) and HAZ ( P = @ ) were associated with faster resolution of tachypnea .


Increased C-reactive protein was associated with a longer duration of tachypnea ( P = @ ) .


Zinc did not affect time to pneumonia resolution or treatment failure , nor did type of respiratory pathogens affect outcomes .


Higher basal zinc and better HAZ and WHZ were associated with reduced time to resolution of respiratory signs .


These results suggest the need for prevention of chronic zinc deficiency and improvement of general nutritional status among Ecuadorian children .


Perioperative red blood cell transfusion is associated with adverse outcomes after cardiac operations .


Although restrictive transfusion protocols have been developed , their safety and efficacy are not well demonstrated , and considerable variation in transfusion practice persists .


We report our experience with a restrictive transfusion protocol .


We analyzed the outcomes in @ patients undergoing cardiac operations enrolled in a trial conducted at @ centers worldwide .


Blood products were administered on the basis of a transfusion algorithm applied across all centers , with a restrictive transfusion trigger of hemoglobin less than or equal to @ g/dL .


Transfusion was acceptable but not mandatory for hemoglobin @ to @ g/dL .


For hemoglobin @ to @ g/dL , transfusion was acceptable only with evidence for end-organ ischemia .


The patient population was moderately complex , with @ % having combined procedures and @ % having nonelective operations .


The mean EuroSCORE for the population was @ , which predicted a substantial incidence of morbidity and mortality .


Actual outcomes were excellent , with observed mortality of @ % and rates of cerebrovascular accident , myocardial infarction , and acute renal failure @ % , @ % , and @ % , respectively .


The frequency of red blood cell transfusion was @ % , which varied significantly by center .


Most transfusions ( @ % ) were administered for hemoglobin @ to @g/dL ; @ % were administered for hemoglobin @ to @g/dL with evidence for end-organ ischemia ; @ % of patients avoided allogeneic transfusion altogether .


A restrictive transfusion protocol can be safely applied in the care of moderate-risk patients undergoing cardiac operations .


This strategy has significant potential to reduce transfusion and resource utilization in these patients , standardize transfusion practices across institutions , and increase the safety of cardiac operations .


Little is known about how weight loss affects magnetic resonance imaging ( MRI ) of liver fat and volume or liver histology in patients with nonalcoholic steatohepatitis ( NASH ) .


We measured changes in liver fat and liver volume associated with weight loss by using an advanced MRI method .


We analyzed data collected from a previous randomized controlled trial in which @ adult patients with biopsy-proven NASH underwent clinical evaluation , biochemical tests , and MRI and liver biopsy analyses at the start of the study and after @ weeks .


We compared data between patients who did and did not have at least @ % decrease in body mass index ( BMI ) during the study period .


Ten of @ patients had at least a @ % decrease in BMI during the study period .


These patients had a significant decrease in liver fat , which was based on MRI proton density fat fraction estimates ( @ % @ % to @ % @ % , P = @ ) , a relative @ % reduction .


They also had a significant decrease in liver volume ( @ % ) .


However , no significant changes in levels of alanine aminotransferase or aspartate aminotransferase were observed with weight loss .


Thirty-three patients without at least @ % decrease in BMI had insignificant increases in estimated liver fat fraction and liver volume .


A reduction in BMI of at least @ % is associated with significant decrease in liver fat and volume in patients with biopsy-proven NASH .


These data should be considered in assessing effect size in studies of patients with nonalcoholic fatty liver disease or obesity that use MRI-estimated liver fat and volume as end points .


There are no robust guidelines on strategies to prevent the adverse skeletal effects of glucocorticoids in children .


To evaluate the role of prophylactic calcium and vitamin D on bone health in children with new-onset nephrotic syndrome ( NS ) treated with short-term ( @weeks ) , high-dose glucocorticoids .


Prospective , randomized , controlled , single blind , interventional study conducted on @ steroid-nave pre-pubertal children ( @ boys , @ girls ) .


All children received prednisolone for @weeks ( @mg/m ( @ ) / day daily for @weeks , followed by @mg/m ( @ ) / day alternate days for @weeks ) .


Recruited children were randomized into the intervention group ( IG ; vitamin D @,@ IU/day and elemental calcium @mg/day ) and the control group ( CG ) .


Bone mineral content ( BMC ) and bone mineral density ( BMD ) at the lumbar spine ( L@-L@ ) were estimated at baseline and at @weeks .


Mean percentage changes in BMC and BMD in IG and CG were compared .


Children in the IG showed an increase of @ % in BMC versus the CG , who showed an @ % fall ( p < @ ) .


Net intervention-attributable difference in BMC was @ % .


BMD increased in both groups ( IG @ % vs CG @ % ) , but the difference was not statistically significant ( p = @ ) .


Short-term , high-dose glucocorticoid therapy decreases the BMC of the lumbar spine in steroid-nave children with NS .


Vitamin D and calcium co-administration not only prevents this decline , but also enhances BMC of the lumbar spine .


To observe the short-term efficacy , long-term survival time and adverse responses with nedaplatin ( NDP ) or cisplatin ( DDP ) concomitant with other chemotherapy in treating non-small cell lung cancer .


A retrospective , randomized , control study was conducted , in which @ NSCLC patients in phases III and IV who were initially treated and re-treated were randomly divided into an NDP group ( n = @ ) and a DDP group ( n = @ ) , the latter being regarded as controls .


Chemotherapeutic protocols ( CP/DP/GP / NP/TP ) containing NDP or DDP were given to both groups .


Patients in both groups were further divided to evaluate the clinical efficacies according to initial and re-treatment stage , pathological pattern , type of combined chemotherapeutic protocols , tumor stage and surgery .


The overall response rate ( ORR ) and disease control rate ( DCR ) in the NDP group were @ % and @ % , significantly higher than in the DDP group at @ % and @ % , respectively ( P < @ ) .


In NSCLC patients with initial treatment , squamous carcinoma and phase III , there were significant differences in ORR and DCR between the groups ( P < @ ) , while ORR was significant in patients with adenocarcinoma , GP/TP and in phase IIIa ( P < @ ) .


There was also a significant difference in DCR in patients in phase IIIb ( P < @ ) .


According to the statistical analysis of survival time of all patients and of those in clinical phase III , the NDP group survived significantly longer than the DDP group ( P < @ ) .


The rates of decreased hemoglobin and increased creatinine , nausea and vomiting in the NDP group were evidently lower than in DDP group ( P < @ ) .


NDP concomitant with other chemotherapy is effective for treating NSCLC , with higher clinical efficacy than DDP concomitant with chemotherapy , with advantages in prolonging survival time and reducing toxic and adverse responses .


Electronic monitoring of inhaled asthma medications is one method to measure medication adherence and patterns of use .


Information on the performance of monitors in a randomized controlled trial allows researchers and clinicians to understand their utility and limitations .


The Smartinhaler Tracker is an electronic monitor for metered-dose inhalers ( MDIs ) that records the date , time , and number of actuations .


To determine the performance of the Smartinhaler monitors used in a @-week randomized controlled trial of @ patients with asthma in a real-world setting .


Prestudy use checks involved @ actuations of the MDI , with a further @ performed @ hours later .


Within-study monitor checks , performed before dispensing at clinic visits @ to @ , included a computerized check of monitor clock function , actuation accuracy , and battery life .


Within-study data checks involved computerized checks of monitor clock function before data upload .


Two thousand six hundred seventy-eight of @ monitors ( @ % ) passed prestudy use checks .


Seventy-six of @ monitors ( @ % ) dispensed to participants failed within-study monitor checks .


Fifty-one of @ monitors ( @ % ) malfunctioned before data upload , mostly as a result of fluid immersion .


Ninety-three of @ monitors ( @ % ) were lost or thrown away by participants .


Complete data was available from @ of @ dispensed monitors ( @ % ) and @ of @ returned monitors ( @ % ) .


The Smartinhaler Tracker is a reliable monitor for measuring MDI use in a real-world setting .


Use of extensive monitor and data-checking protocols reduces data loss .


In a research or clinical setting , the use of a validated and reliable electronic monitor represents the reference standard for assessing patterns of medication use .


Cutaneous discomfort is typically reported during transcranial direct current stimulation ( tDCS ) , restricting the current intensity and duration at which tDCS can be applied .


It is commonly thought that current density is associated with the intensity of perceived cutaneous perception such that larger electrodes with a lower current density results in milder cutaneous sensations .


The present study examined the relationship between current density , current intensity and cutaneous sensations perceived during tDCS .


Two experiments were performed .


In the first control experiment , the cutaneous sensations induced by varying current intensities ( @ , @ , @ and @ mA ) were examined up to @ min .


These data were used for optimizing inter-stimulation intervals in the second main experiment , where participants rated the intensity , spatial size and location of the cutaneous sensations experienced during tDCS using two electrodes sizes ( @ cm@ and @ cm@ ) .


In the equivalent current density condition , the current density was kept constant under both electrodes ( @ , @ and @ mA/cm@ ) , whereas in the equal current intensity condition ( @ , @ and @ mA ) the same intensities were used for the two electrode sizes .


Large electrodes were associated with greater cutaneous discomfort when compared to smaller electrodes at a given current density .


Further , levels of cutaneous perception were similar for small and large electrodes when current intensity was kept constant .


Cutaneous sensations during stimulation can be minimized by reducing the electrode size from @ cm@ to @ cm@ .


We compared the efficacy and safety of the currently recommended dose of pentosan polysulfate sodium with a third of the daily dose and with placebo .


In this multicenter , double-blind , randomized , placebo controlled study @ adults with interstitial cystitis/bladder pain syndrome , defined as an ICSI total score of @ or greater and a score of greater than @ on the @ ICSI component items , received pentosan polysulfate sodium @ mg once daily or @ times daily , or matching placebo for @ weeks .


Study eligibility was not based on cystoscopy findings .


ICSI was administered at baseline , and at weeks @ , @ , @ , @ and @ .


Unblinded interim analysis performed at @ years with @ % of the target number of @ patients enrolled resulted in early study termination .


There was no statistically significant difference between the pentosan polysulfate sodium group and the placebo group or between the @ pentosan polysulfate sodium groups for the primary end point , defined as responder achieving a @ % or greater reduction from the baseline ICSI total score at study end .


This primary end point was achieved by @ of @ patients ( @ % ) in the placebo group , and by @ of @ ( @ % ) and @ of @ ( @ % ) in the pentosan polysulfate sodium @ mg once daily and @ times daily groups , respectively .


Pentosan polysulfate sodium was well tolerated with a similar percent of patients ( range @ % to @ % ) across the groups discontinuing due to an adverse event .


Results of this study in a broad population of patients with symptoms consistent with interstitial cystitis revealed no treatment effect vs placebo for pentosan polysulfate sodium at the currently established dose or at a third of the daily dose .


To date , no randomized study has investigated the value of optical coherence tomography ( OCT ) in optimizing the results of coronary angioplasty for non-ST-segment elevation acute coronary syndromes .


DOCTORS is a randomized , prospective , multicenter , open-label clinical trial to evaluate the utility of OCT to optimize results of angioplasty of a lesion responsible for non-ST-elevation acute coronary syndromes .


Patients ( n = @ ) will be randomized to undergo OCT-guided angioplasty ( use of OCT to optimize procedural result , including change to strategy with the possibility of additional interventions ) or angioplasty under fluoroscopy alone .


The primary end point is the functional result of the angioplasty procedure as assessed by fractional flow reserve ( FFR ) measured at the end of the procedure .


Secondary end points include safety of OCT in the context of angioplasty for ACS , percentage of patients in whom OCT reveals suboptimal result of stenting , percentage of patients in whom a change in procedural strategy is decided based on OCT data , correlation between quantitative measures by OCT and FFR , determination of a threshold for quantitative OCT measure that best predicts FFR @ , and identification of OCT variables that predict postprocedure FFR .


Adverse cardiac events ( death , recurrent myocardial infarction , stent thrombosis , and repeat target lesion revascularization ) at @ months will be recorded .


The DOCTORS randomized trial ( ClinicalTrials.gov NCT@ ) is designed to investigate whether use of OCT yields useful additional information beyond that obtained by angiography alone and , if so , whether this information changes physician strategy and impacts on the functional result of angioplasty as assessed by FFR .


Disposable electrocardiographic lead wires ( ECG-LWs ) may not be as durable as reusable ones .


To examine differences in alarm events between disposable and reusable ECG-LWs .


Two cardiac telemetry units were randomized to reusable ECG-LWs , and @ units alternated between disposable and reusable ECG-LWs for @ months .


A remote monitoring team , blinded to ECG-LW type , assessed frequency and type of alarm events by using total counts and rates per @ patient days .


Event rates were compared by using generalized linear mixed-effect models for differences and noninferiority between wire types .


In @ patients and @ patient days of ECG monitoring , patient characteristics were similar between groups .


Rates of alarms for no telemetry , leads fail , or leads off were lower in disposable ECG-LWs ( adjusted relative risk -LSB- @ % CI -RSB- , @ -LSB- @-@ @ -RSB- ; noninferiority P < @ ; superiority P = @ ) and monitoring ( artifact ) alarms were significantly noninferior ( adjusted relative risk -LSB- @ % CI -RSB- : @ , -LSB- @-@ @ -RSB- , P = @ ; superiority P = @ ) .


No between-group differences existed in false or true crisis alarms .


Disposable ECG-LWs were noninferior to reusable ECG-LWs for all false-alarm events ( N -LSB- rate per @ patient days -RSB- , disposable @ -LSB- @ -RSB- vs reusable @ -LSB- @ -RSB- ; adjusted relative risk -LSB- @ % CI -RSB- : @ -LSB- @-@ @ -RSB- , P = @ ; superiority P = @ . )


Disposable ECG-LWs with patented push-button design had superior performance in reducing alarms created by no telemetry , leads fail , or leads off and significant noninferiority in all false-alarm rates compared with reusable ECG-LWs .


Fewer ECG alarms may save nurses time , decrease alarm fatigue , and improve patient safety .


Atrial tachyarrhythmias ( AT ) commonly recur within the first @ months after radiofrequency catheter ablation ( RFCA ) of atrial fibrillation ( AF ) , and the influence of antiarrhythmic drugs ( AADs ) on the recurrences has not been fully elucidated .


We sought to evaluate the efficacy of a @-month lower-dose flecainide regime on early and late recurrences of ATs .


We randomly assigned @ patients , who underwent RFCA for AF , to the flecainide group ( @ or @ mg/day according to their body weight ) or to the control group receiving no AADs .


The primary endpoint was any AT lasting for @ s during the first @ months and the secondary endpoint was a composite of ATs lasting for @ h or requiring cardioversion or hospitalization during the same period .


All AADs were stopped after the first @ months and the late arrhythmia recurrences were also evaluated .


The primary endpoint rates were @ and @ % in the flecainide ( @ @ mg/day ) and control groups , respectively ( log-rank P = @ ) , and those of the secondary endpoint were @ and @ % , respectively ( log-rank P = @ ) .


The estimated rates of maintaining sinus rhythm at @ months after the first @ months were @ and @ % , in the flecainide and control groups , respectively ( log-rank P = @ ) , and the rates were @ and @ % in those with and without the primary endpoint , respectively ( log-rank P < @ ) .


The @-month lower-dose flecainide therapy after AF ablation did not reduce the early and late arrhythmia recurrences .


The clinically significant ATs were also not prevented .


Motor relearning protocols should involve task-oriented movement , focused attention , and repetition of desired movements .


To investigate the effect of intensive gait training with rhythmic auditory stimulation on postural control and gait performance in individuals with chronic hemiparetic stroke .


Twenty patients with chronic hemiparetic stroke participated in this study .


Subjects in the Rhythmic auditory stimulation training group ( @ subjects ) underwent intensive gait training with rhythmic auditory stimulation for a period of @ weeks ( @ min/day , five days/week ) , while those in the control group ( @ subjects ) underwent intensive gait training for the same duration .


Two clinical measures , Berg balance scale and stroke specific quality of life scale , and a @-demensional gait analysis system , were used as outcome measure .


To provide rhythmic auditory stimulation during gait training , the MIDI Cuebase musical instrument digital interface program and a KM Player version @ was utilized for this study .


Intensive gait training with rhythmic auditory stimulation resulted in significant improvement in scores on the Berg balance scale , gait velocity , cadence , stride length and double support period in affected side , and stroke specific quality of life scale compared with the control group after training .


Findings of this study suggest that intensive gait training with rhythmic auditory stimulation improves balance and gait performance as well as quality of life , in individuals with chronic hemiparetic stroke .


To assess the dentin hypersensitivity-reducing effectiveness of a @ % stannous-containing dentifrice as compared to a marketed negative control dentifrice after the first brushing as well as after @ days and @ weeks of twice daily use .


This was a @-week , randomized , double-blind , parallel group , single-center clinical investigation in confirmed dentin hypersensitivity adult sufferers .


At baseline , subjects were stratified by age , gender , and thermal sensitivity scores , and randomly assigned to a marketed @ % stannous fluoride ( SnF@ ) dentifrice or a marketed sodium fluoride ( NaF ) dentifrice negative control .


Following baseline assessment of tactile and thermal sensitivity via the Yeaple Probe and air-blast/Schiff Air Index evaluations , respectively , subjects brushed once on-site with their assigned test product following the same usage instructions .


Post-brushing tactile and thermal sensitivity were then assessed ( ` Immediate ' evaluation ) .


Subjects subsequently brushed twice daily at home for a @-week period , with the same tactile and thermal efficacy evaluations repeated at Day @ and Week @ post-baseline .


All @ enrolled subjects completed all evaluations .


The stannous fluoride dentifrice provided significantly ( P < @ ) superior dentin hypersensitivity reduction compared to the negative control dentifrice at each time point and by both evaluation measures : superior mean relative Yeaple Probe ( tactile ) benefits were @ % after one use , @ % after @ days , and @ % after @ weeks ; and superior mean relative Schiff Air Index ( thermal ) benefits were @ % after a single use , @ % at Day @ , and @ % at Week @ .


Both dentifrices were well-tolerated .


To evaluate the efficacies of modified chitosan , an adhesive prevention substance , as a biological barrier for preventing adhesion after Cesarean section .


A total of @ cases undergoing primary Cesarean section from January @ to June @ at our hospital were recruited .


They were randomly divided into experiment ( n = @ ) and control ( n = @ ) groups .


The experiment group received modified chitosan during Cesarean section while no adhesive prevention substance was offered for the control group .


Postoperative flatus time , postoperative infection and pelvic adhesion were used to evaluate the clinical efficacies .


For the experiment group , the average postoperative flatus time was ( @ @ ) hours .


Three cases had postoperative infections with a postoperative infection rate of @ % .


There were @ cases of pelvic adhesion ( pelvic adhesion rate : @ % ) during the postoperative follow-up period .


For the control group , the average postoperative flatus time was ( @ @ ) hours .


Five cases had postoperative infections with a postoperative infection rate of @ % .


There were significant inter-group differences in postoperative flatus time , postoperative infection and pelvic adhesion ( P < @ ) .


Modified chitosan can prevent pelvic adhesion after Cesarean section .


Baseline patients ' characteristics are critical for treatment planning , as these can be moderators of treatment effects .


In Mexico , information on treatment seekers with substance use disorders is scarce and limited to demographic characteristics .


This paper presents and analyses demographic characteristics , substance use related problems , clinical features , and addiction severity in a sample of treatment seekers from the first multi-site randomized clinical trial implemented in the Mexican Clinical Trials Network on Addiction and Mental Health .


A total of @ participants were assessed prior randomization .


Chi square or F-tests were used to compare sites across variables .


Spearman correlation was used to associate negative consequences of substance use and motivation to change .


The majority of participants were men , and the most prevalent substances reported were alcohol , marijuana , and cocaine .


Participants were predominantly on the contemplation or action stage of change , and this was correlated with the perception of the negative consequences associated with substance use .


Participants reported a high prevalence of substance use related problems .


Substance use related problems , clinical features , and addiction severity reported by treatment seekers are important characteristics to take into account when planning treatment as they facilitate tailoring treatment to meet patients ' needs .


The aim was to compare endovenous laser ablation ( EVLA ) and endovenous steam ablation ( EVSA ) for great saphenous varicose veins in a non-inferiority study .


Patients with primary great saphenous vein reflux were randomized to EVLA ( @nm ) or EVSA ( SVS ) .


Primary outcomes were treatment success ( vein obliteration or abolition of reflux ) -LSB- corrected -RSB- at @weeks , and Venous Clinical Severity Score ( VCSS ) at @weeks .


Secondary outcomes were pain , satisfaction with treatment , duration of analgesia use and days lost from daily activities , changes in Aberdeen Varicose Vein Questionnaire ( AVVQ ) and EQ-@D scores after @weeks , and complications at @ and @weeks .


A total of @ legs were treated ( EVSA , @ ; EVLA , @ ) ; @ legs treated with EVSA received a low dose and the remaining @ a higher dose .


At @ year , the treatment success rate after high-dose EVSA was not inferior to that of EVLA : @ ( @ per cent confidence interval ( c.i. ) @ to @ ) versus @ ( @ to @ ) per cent respectively .


Changes in VCSS after @weeks were similar : -@ ( @ per cent c.i. -@ to -@ ) and -@ ( -@ to -@ ) .


AVVQ , EQ-@D and EQ VAS scores improved equally @weeks after both treatments .


Patients treated with EVSA reported less postprocedural pain , fewer days of analgesia use , were more satisfied with therapy , and had a shorter convalescence .


Complication rates were comparable .


The @-year treatment success of high-dose EVSA was not inferior to that of EVLA .


Several secondary outcomes were in favour of EVSA .


Registration number NCT@ ( http://www.clinicaltrials.gov ) .


Recommendations for surgical , compared with lifestyle and pharmacologically based , approaches for type @ diabetes ( T@D ) management remain controversial .


The objective was to compare laparoscopic adjustable gastric band ( LAGB ) to an intensive medical diabetes and weight management ( IMWM ) program for T@D .


This was designed as a prospective , randomized clinical trial .


The setting was two Harvard Medical School-affiliated academic institutions .


INTERVENTIONS AND PARTICIPANTS : A @-month randomized trial comparing LAGB ( n = @ ) vs IMWM ( n = @ ) in persons aged @-@ years with body mass index of @-@ kg/m ( @ ) , T@D diagnosed more than @ year earlier , and glycated hemoglobin ( HbA ( @c ) ) @ % on antihyperglycemic medication ( s ) .


The proportion meeting the prespecified primary glycemic endpoint , defined as HbA ( @c ) < @ % and fasting glucose < @ mmol/L at @ months , on or off medication .


After randomization , five participants did not undergo the surgical intervention .


Of the @ initiating intervention ( @ males/@ females ; age , @ @ y ; body mass index , @ @ kg/m ( @ ) ; diabetes duration , @ @ y ; HbA ( @c ) , @ @ % ; @ % on insulin ) , the proportion meeting the primary glycemic endpoint was achieved in @ % of the LAGB patients and @ % of the IMWM patients ( P = @ ) .


HbA ( @c ) reduction was similar between groups at both @ and @ months ( -@ @ vs -@ @ % ; P = @ ) .


Weight loss was similar at @ months but greater @ months after LAGB ( -@ @ vs -@ @ kg ; P = @ ) .


Systolic blood pressure reduction was greater after IMWM than LAGB , whereas changes in diastolic blood pressure , lipids , fitness , and cardiovascular risk scores were similar between groups .


Patient-reported health status , assessed using the Short Form-@ , Impact of Weight on Quality of Life , and Problem Areas in Diabetes , all improved similarly between groups .


LAGB and a multidisciplinary IMWM program have similar @-year benefits on diabetes control , cardiometabolic risk , and patient satisfaction , which should be considered in the context of other factors , such as personal preference , when selecting treatment options with obese T@D patients .


Longer duration studies are important to understand emergent differences .


Autism spectrum disorders ( ASDs ) have core impairments in social communication as well as the presence of repetitive , stereotypic behaviors and restricted interests .


Older adolescents and young adults are particularly impacted by these deficits .


Preclinical data implicate glutamatergic dysfunction in the pathophysiology of ASDs .


D-Cycloserine ( DCS ) , a partial glycineB agonist at the N-methyl-D-aspartic acid receptor site , has been shown to improve sociability in mouse models and a small human study .