In two cases , AEs were classified as serious because of hospitalisation : paronychia in a placebo subject and pleurisy in a MOR103 0.3 mg/kg subject .


Both patients recovered fully .


In exploratory efficacy analyses , subjects in the MOR103 1.0 and 1.5 mg/kg groups showed significant improvements in Disease Activity Score-28 scores and joint counts and significantly higher European League Against Rheumatism response rates than subjects receiving placebo .


MOR103 1.0 mg/kg was associated with the largest reductions in disease activity parameters .


MOR103 was well tolerated and showed preliminary evidence of efficacy in patients with active RA .


The data support further investigation of this monoclonal antibody to GM-CSF in RA patients and potentially in those with other immune-mediated inflammatory diseases .


NCT01023256 .


Home visiting nurses ( HVNs ) have long been part of home and community-based care interventions designed to meet the needs of functionally declining older adults .


However , only one of the studies including HVNs that have demonstrated successful impacts on Activities of Daily Living ( ADL ) has reported how those interventions affected individual ADLs such as bathing , instead reporting the effect on means of various ADL indices and scales .


Reporting impacts on means is insufficient since the same mean can consist of many different combinations of individual ADL impairments .


The purpose of our study was to identify which individual ADLs were affected by a specific HVN intervention .


This is a secondary analysis comparing two arms of a randomized controlled study that enrolled Medicare patients ( mean age = 76.8 years ; 70 % female ) with considerable ADL impairment .


At baseline difficulty with individual ADLs ranged from a low of 16.0 % with eating to a high of 78.0 % with walking .


Through monthly home visits , the HVN focused on empowering patients and using behavior change approaches to facilitate chronic disease self-management .


Three categories of analyses were used to compare difficulty with and dependence in 6 individual ADLs between the HVN ( n = 237 ) and care as usual ( n = 262 ) groups ( total N = 499 ) at 22 months after study entry : ( 1 ) unadjusted analyses that strictly depend on random assignment , ( 2 ) multinomial logistic regression analyses adjusting for baseline risk factors , and ( 3 ) multinomial regression analyses that include variables reporting post-randomization healthcare use as well as the baseline risk factors .


Compared to care as usual , patients receiving the HVN intervention had less difficulty performing bathing at 22 months .


However , there were no effects for difficulty performing the other 5 ADLs .


While no effects were found for lower levels of dependence for any ADLs , impacts were detected for the most dependent levels of 4 ADLs : patients experienced less dependence in walking and transferring , a substitution effect for toileting , and more dependence in eating .


Future research is needed to confirm these findings and determine how HVN interventions affect individual ADLs of older adults with multiple ADLs .


Endoscopic submucosal dissection ( ESD ) is the gold standard technique for en bloc resection of large superficial tumors in the upper and lower gastrointestinal tract .


Little is known about the management of epigastric pain after ESD of gastric neoplasms .


This study investigated the utility and safety of single-dose , perioperative , intravenous dexamethasone for epigastric pain relief following ESD .


The efficacy of intravenous dexamethasone 0.15 mg/kg ( DEXA group ) compared with saline-only placebo ( placebo ) for epigastric pain after ESD of early gastric neoplasms was assessed in a double-blinded , placebo-controlled trial .


Patients completed a questionnaire about present pain intensity ( PPI ) and short-form McGill pain ( SF-MP ) categories for immediate and 6 - , 12 - , and 24-h postoperative periods .


The primary outcome variable was PPI at 6 h following ESD .


Secondary outcome variables included pain medication , SF-MP scores , complications , second-look endoscopic findings , and length of stay .


A total of 36 patients participated in the study .


The mean 6-h PPI value was lower ( p < 0.001 ) in the DEXA group ( 1.61 0.21 ) than in the placebo group ( 2.66 0.19 ) .


The total 6-h SF-MP score , especially the sensory domain , was higher ( p = 0.054 ) in the placebo group ( 11.56 0.75 ) than in the DEXA group ( 8.89 0.75 ) .


Tramadol for epigastric pain relief was more frequent ( p = 0.026 ) in the placebo group ( 44.4 % ) than in the DEXA group ( 11.1 % ) .


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


The distribution of artificial ulcer patterns at 48-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 6 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 2589 patients with acute VTE treated with low-molecular-weight or unfractionated heparin for 5 to 11 days , we compared dabigatran 150 mg twice daily with warfarin .


The primary outcome , recurrent symptomatic , objectively confirmed VTE and related deaths during 6 months of treatment occurred in 30 of the 1279 dabigatran patients ( 2.3 % ) compared with 28 of the 1289 warfarin patients ( 2.2 % ; hazard ratio , 1.08 ; 95 % confidence interval [ CI ] , 0.64-1 .80 ; absolute risk difference , 0.2 % ; 95 % CI , -1.0 to 1.3 ; P < 0.001 for the prespecified noninferiority margin for both criteria ) .


The safety end point , major bleeding , occurred in 15 patients receiving dabigatran ( 1.2 % ) and in 22 receiving warfarin ( 1.7 % ; hazard ratio , 0.69 ; 95 % CI , 0.36-1 .32 ) .


Any bleeding occurred in 200 dabigatran ( 15.6 % ) and 285 warfarin ( 22.1 % ; hazard ratio , 0.67 ; 95 % CI , 0.56-0 .81 ) 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 1.09 ( 95 % CI , 0.76-1 .57 ) , for major bleeding of 0.73 ( 95 % CI , 0.48-1 .11 ) , and for any bleeding of 0.70 ( 95 % CI , 0.61-0 .79 ) .


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


www.clinicaltrials.gov .


Unique identifiers : NCT00680186 and NCT00291330 .


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 20 .


One hundred and ninety eight students out of 239 ( 83 % ) 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 .


158 ( 80 % ) considered the session useful and 139 ( 69 % ) 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 10-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 , 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical ( Clin ) or the Commercial ( Com ) lot of PHiD-CV at 2 , 3 , and 5 months of age .


In the booster vaccination phase , 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age .


Immune responses to pneumococcal polysaccharides were measured using 22F-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 , 93.6 % and 88.5 % of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations 0.2 g/mL and OPA titres 8 , in the Clin and Com groups , respectively .


For each vaccine pneumococcal serotype , 60.8 % and 98.2 % of toddlers from Singapore had pre - and post-booster antibody concentrations 0.2 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 3 solicited symptom was 11.1 % 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.govNCT00808444 and NCT01119625 .


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 337 patients with symptomatic paroxysmal or persistent AF within 6 months of enrollment .


Patients were randomized to fish oil ( 4 g/day ) or placebo and followed , on average , for 271 129 days .


The primary endpoint was time to first symptomatic or asymptomatic AF recurrence lasting > 30 s. Secondary endpoints were high-sensitivity C-reactive protein ( hs-CRP ) and myeloperoxidase ( MPO ) .


The primary endpoint occurred in 64.1 % of patients in the fish oil arm and 63.2 % of patients in the placebo arm ( hazard ratio : 1.10 ; 95 % confidence interval : 0.84 to 1.45 ; p = 0.48 ) .


hs-CRP and MPO were within normal limits at baseline and decreased to a similar degree at 6 months ( hs-CRP , 11 % vs.-11 % ; MPO,-5 % vs.-9 % 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-3 Fatty Acids [ OMEGA-3 ] on Arrhythmia Recurrence in Atrial Fibrillation [ AFFORD ] ; NCT01235130 ) .


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 2-cm short-segment ulnar motor NCS across the elbow were performed in 49 controls and 67 UNE patients .


In controls , subclinical UNE was diagnosed if at least 2 studies were outside the reference limits in the same 2-cm segment .


Exclusion of controls with subclinical UNE produced less stringent normative values ( 2-cm conduction velocity : 25 to 31 m/s ; US cross-sectional area : 11.6 to 9.6 mm2 ) , which raised diagnostic sensitivity ( short-segment NCS : 76 % to 90 % ; 10-cm NCS : 72 % to 85 % , US : 43 % to 79 % ) .


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 0.2 % 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 0.2 % 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 48 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 1 and 2 , quadriceps maximum voluntary isometric contraction , distance ambulated during physical therapy , postoperative nausea and vomiting , and satisfaction with analgesia .


Eighty subjects were randomized , and 76 completed the study per-protocol .


The least-square mean difference in cumulative morphine consumption over 48 hours ( block-sham ) was -- 16.68 mg ( 95 % confidence interval , -29.78 to -3.59 , P = 0.013 ) .


Total morphine use between 24 and 48 hours ( after predicted femoral nerve block resolution ) also differed by least-square mean -11.17 mg ( 95 % confidence interval , : -19.93 to -2.42 , P = 0.013 ) .


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 = 0.010 ) and further distance ambulated ( P = 0.034 ) on postoperative day 2 .


A continuous adductor canal block for total knee arthroplasty reduces opioid consumption compared with that of placebo in the first 48 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 120 patients who undeiwent ESWL for renal stones of 0.5-2 .0 cm .


They were randomized into study and control group in which Tamsulosin 0.4 mg/day was given in former as an adjunctive medical therapy .


All patients underwent ESWL every 2 weeks until complete stone clearance for 8 weeks .


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


Of the 120 patients 60 were in each group .


The stone clearance rate was greater in study than in control group , 58 ( 96.7 % ) vs. 48 ( 80 % ) respectively , ( p < 0.004 ) .


The mean stone clearance time was observed earlier in study group as compared to control group with significant statistical difference in stone size between 0.6-1 .


Scm.The mean intensity of pain patients experienced according to Visual analogue scale ( VAS ) was significantly less in study group ( p < 0.002 ) .


The rate of steinstrasse formation was observed to be higher in control than in study group 15 ( 25 % ) vs 6 ( 10 % ) respectively ( p < 0.003 ) , while its spontaneous clearance was higher in study group than in control group 83.3 % vs 33.3 % ( p < 0.03 ) .


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 1/12 of their 24-hour morphine dose as RMD or 60 percent of this dose as SCM .


Perceived breathlessness was evaluated on a Visual Analogue Scale ( VAS ) during a 60 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 1.1 [ RMD ] and 1.7 [ SCM ] ) and pulse rate ( mean decrease of 4 per minute [ RMD ] and 6 per minute [ SCM ] ) , 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 3 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 3 and 6 months [ American College of Rheumatology response , 28-joint Disease Activity Score ( DAS28 ) - C-reactive protein ( CRP ) improvement and targets ] .


`` Month 3 '' responders met the clinical measure at both months 3 and 6 , and `` Month 6 '' responders met the clinical measure only at Month 6 .


The odds of achieving longterm outcomes [ remission ( DAS28-CRP < 2.6 ) , normal function ( Health Assessment Questionnaire-Disability Index < 0.5 ) , or rapid radiographic progression ( modified total Sharp score > 3 U/yr ) ] 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 6 responders demonstrated worse clinical , functional , and radiographic outcomes than Month 3 MTX and Month 3 or 6 ADA + MTX responders .


Although similar longterm benefit was observed for ADA + MTX responders , delayed ( Month 6 ) responders exhibited downward trends in clinical , functional , and radiographic outcomes that were comparable with those experienced by Month 3 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 3 clinical response have less-favorable outcomes than other groups , while outcomes in ADA + MTX Month 3 and Month 6 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 3 % ointment as monotherapy .


This was a single-centre , randomized , single-blind , vehicle-controlled pilot study in adult patients ( n = 46 ) with 4weeks of treatment and 4weeks 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 4 ( P < 0.001 ) .


The praziquantel group experienced a greater improvement in mean DLQI .


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


Praziquantel ointment 3 % 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 6-26weeks ' 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 23-item test of content knowledge immediately and 2-4weeks after exposure .


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


A total of 150 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 ( 69.4 % 14.2 % vs. 46.0 % 15.2 % , p < 0.001 ) on the immediate questionnaire .


One hundred and twenty-three ( 82 % ) participants participated in the follow-up test .


Women randomized to the tool continued to correctly answer a significantly greater proportion of questions ( 60.6 % 16 % vs. 49.7 % 18.9 % , p = 0.001 ) .


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 2010 , a total of 159 patients [ mean AIR ( Appendicitis Inflammatory Response ) score = 4.9 and mean Alvarado score = 5.2 ] with suspected appendicitis were enrolled and underwent nonoperative management ( NOM ) with amoxicillin/clavulanate .


The follow-up period was 2 years .


Short-term ( 7 days ) NOM failure rate was 11.9 % .


All patients with initial failures were operated within 7 days .


At 15 days , no recurrences were recorded .


After 2 years , the overall recurrence rate was 13.8 % ( 22/159 ) ; 14 of 22 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 3 at 5 days and 2 after 7 days .


Mean length of stay of nonoperatively managed patients was 0.4 days , and mean sick leave period was 5.8 days .


Long-term efficacy of NOM treatment was 83 % ( 118 patients recurrence free and 14 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 & OV0556 ; 316.20 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 2 years of follow-up , recurrences of nonoperatively treated right lower quadrant abdominal pain are less than 14 % 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 3-month evaluations included resting BP ; overnight urine samples ; and saliva collected at bedtime , upon awakening , and at 30 and 60 minutes after awakening for - amylase and cortisol assays .


Twenty-eight ( 14 in the HYP group and 14 in the AC group ) students were assessed both before and after the intervention .


BP changes from pre - to post-intervention were -3.0 / -2.0 mmHg for the HYP group and -0.07 / -0.79 mmHg for the AC group ( p = 0.30 and 0.57 , respectively ) .


Changes in systolic BP ( SBP ) / diastolic BP ( DBP ) for the prehypertensive ( 75th-94th percentiles for SBP ) subgroup analyses were -10.75 / -8.25 mmHg for the HYP group ( n = 4 ) versus 1.8 / 1.0 mmHg for the AC group ( n = 5 ) ( p for SBP = 0.02 ; p for DBP = 0.09 ) .


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 = 0.34 ; prehypertensive d = 0.20 ) .


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 60 healthy ( previously vaccinated ) male human volunteers , aged 19-23 years to receive one dose of either Sabin IPV ( 20:32:64 DU/dose ) , adjuvanted Sabin IPV ( 10:16:32 DU/dose ) , or conventional Salk IPV ( 40:8:32 DU/dose ) .


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


The secondary endpoint measured boosting immune responses ( i.e. seroconversion or 4-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 6-month follow-up period .


Twenty-eight days after vaccination , boosting immune responses against poliovirus types 1-3 were between 90 % and 100 % in all vaccination groups .


There was a more than 6-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 50 % ( 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 24 months in participants who achieved normal glucose tolerance ( NGT ) at 6 months ( NGT-6 m ) compared with the other participants , b ) the factors influencing the reversal to NGT at the end of the study at 24 months ( NGT-24 m ) , and c ) to assess changes in cardiometabolic risk factors in different categories of dysglycemia at 24 months .


Data from a 2-year primary prevention trial were used .


Effect of reversion to NGT-6 m on incidence of type 2 diabetes mellitus ( T2DM ) 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 T2DM in 2 years was lower by 75 % in NGT-6 m group ( hazard ratio 0.25 [ 95 % CI 0.12-0 .52 ] ) .


Predictive variables for reversal to NGT-24 m were good baseline - cell function ( odds ratio [ OR ] 2.79 [ 95 % CI 2.30-3 .40 ] ) and its further improvement ( OR 5.70 [ 95 % CI 4.58-7 .08 ] ) , and NGT-6 m ( OR 2.10 [ 95 % CI 1.14-3 .83 ] ) .


BMI decreased in those who reverted to NGT .


Deterioration to T2DM 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-6 m were associated with reversion to NGT-24 months .


Reversion to NGT was associated with modest improvements , whereas conversion to T2DM 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 179 patients aged 40 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-36 and costs using 2005 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 $ 2,975 .


The sensitivity analysis revealed that there is an 85.8 % probability that HL is cost-effective if decision-makers are willing to pay $ 50,000 .


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 ( NCT01466387 ) .


Healthy adults aged 18 to 60 years were randomized to one of four vaccine regimens : JEV + PCECV + MenACWY-CRM , JEV + PCECV , PCECV or MenACWY-CRM .


Immunogenicity at baseline and 28 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 98-99 % ( JE ) and 100 % ( 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 .


NCT01466387 .


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 , 835 of 1149 patients ( 72.7 % ) participating in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) at 43 CATT clinical centers .


Each patient was genotyped for 7 SNPs in VEGFA ( rs699946 , rs699947 , rs833069 , rs833070 , rs1413711 , rs2010963 , and rs2146323 ) and 1 SNP in VEGFR2 ( rs2071559 ) using TaqMan SNP genotyping assays .


Genotypic frequencies were compared with clinical measures of response to therapy at 1 year , including the mean visual acuity , mean change in visual acuity , at least a 15-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 : rs699947 ( P = .03 ) , rs833070 ( P = .04 ) , rs1413711 ( P = .045 ) , and rs2146323 ( P = .006 ) .


However , adjusted P values for these associations were all statistically nonsignificant ( range , P = .24 to P = .45 ) .


Among the participants in 2 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 > .01 for all ) .


This study provides evidence that no pharmacogenetic associations exist between the studied VEGFA and VEGFR2 SNPs and response to anti-VEGF therapy .


clinicaltrials.gov Identifier : NCT00593450 .


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 .


136 patients undergoing off-pump coronary artery bypass grafting were single-blindly assigned randomly to landiolol ( n = 68 ) and non-landiolol ( control , n = 68 ) groups .


In the landiolol group , the beta blocker was administered from the beginning of the operation until postoperative day 2 .


The primary endpoint was the incidence of atrial fibrillation until postoperative day 7 , 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 ( 13/68 , 19 % vs. 25/68 , 37 % , p = 0.02 , logrank test ) .


Landiolol also significantly reduced the postoperative peak C-reactive protein level compared to the control group ( 13255.4 vs. 16150.9 mgL ( -1 ) , p = 0.004 ) .


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


Magnesium sulphate ( MgSO4 ) , NMDA receptor antagonist , is known to reduce perioperative requirement of anesthetics and analgesics .


However , no studies assessed the effect of MgSO4 on onset and recovery from spinal anesthesia .


A prospective , randomised , double blind study was designed to assess the effect of intravenous ( IV ) MgSO4 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 MgSO4 50 mg kg ( -1 ) in 10 mL within 10 min , followed by an infusion of MgSO4 10 mg kg ( -1 ) hr ( -1 ) IV in 4mL ( MG group ) for 12 hrs or normal saline in same volume and rate for 12 hrs as used in MG group ( NS group ) .


After initiating the infusion , spinal anesthesia was given with 0.5 % bupivacaine ( Hyperbaric ) 2.5 mL at L3/4 or L4/5 space .


Time taken for sensory block at the level of T-10 and motor block ( modified Bromage Score-1 ) was noted .


Postoperatively , time taken for recovery from spinal anesthesia , pain score and requirement of postoperative analgesic in 24 hours were observed and compared between the two groups .


The first rescue analgesia was required after 334 + / - 202 min in MG group and after 233 + / - 141 min in NS group with significant difference ( p < 0.05 ) .


The morphine required over 24 hours for analgesia was significantly less in MG group ( 3.99 + / - 1.25 mg ) as compared to NS group ( 7.13 + / - 2.68 mg ) ( p < 0.000 ) .


Intravenous MgSO4 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 7 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 [ MAP ] within 10 % 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 45.4 % ( SD 23.9 % ; 95 % CI , 41.5 % -49.18 % ) of the time .


Larger changes in infusion rate were associated with worse BP control ( 7.99 % less control for 1 gkgmin increase in average titration size , P = 0.0009 ) .


A larger difference between a patient 's baseline and target MAP predicted worse BP control ( 0.93 % worse control per 1-mm Hg increase in MAP difference , P = 0.0013 ) .


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 2 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 307 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 18.0 % ( n = 55 ) 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 6.0 % 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 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis .


Patients were recruited in the period October 2011 to July 2013 , and the follow-up period is one year from date of surgery .


Patients are allocated on a 1:2 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-5D ) 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 .


Current Controlled Trials ISRCTN42281022 .


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 5 years old ( n = 338 ) were randomly assigned to artesunate-amodiaquine , atovaquone-proguanil , or artesunate-atovaquone-proguanil treatment groups and followed for 28 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 16 failures ( 8 late and 8 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 3 drugs .


However , the proportion of atovaquone-proguanil-treated patients with positive smears on day 3 was much higher ( 36.0 % ; P < .05 ) than that of the artesunate-amodiaquine ( 2.9 % ) and artesunate-atovaquone-proguanil ( 1.0 % ) 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 .


UMIN000003813 .


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-16 / 18 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 ; NCT00128661 ) and ~ the PATRICIA trial ( NCT001226810 ) , two phase 3 , double-blind , randomised controlled clinical trials of the HPV-16 / 18 AS04-adjuvanted vaccine in young women , were combined in a post-hoc analysis ( GlaxoSmithKline [ GSK ] e-track number 202142 ) to investigate the efficacy of fewer than three doses of the HPV-16 / 18 vaccine after 4 years of follow-up .


Women were randomly assigned to receive three doses of the HPV-16 / 18 vaccine or to a control vaccine ; yet , some received fewer doses .


After exclusion of women with less than 12 months of follow-up or those who were HPV-16 / 18 DNA-positive at enrolment ( for the HPV-16 / 18 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-16 / 18 infections accumulated during the follow-up phase .


We assessed vaccine efficacy against incident HPV-16 / 18 infection in the modified total vaccinated cohort ( 22327 received three doses , 1185 two doses , 543 one dose ) .


Vaccine efficacy against incident HPV-16 / 18 infections for three doses was 770 % ( 95 % CI 747-791 ) , two doses was 760 % ( 620-853 ) , and one dose was 857 % ( 707-937 ) .


Vaccine efficacy against incident HPV-31 / 33/45 infections for three doses was 597 % ( 560-630 ) , two doses was 377 % ( 124-559 ) , and one dose was 366 % ( -54 to 622 ) .


Vaccine efficacy against incident HPV-16 / 18 infection for two-dose women who received their second dose at 1 month was 753 % ( 542-875 ) and 826 % ( 423-961 ) for those who received the second dose at 6 months ( CVT data only ) .


Vaccine efficacy against HPV-31 / 33/45 for two-dose women who received their second dose at 6 months ( 681 % , 270-870 ; CVT data only ) , but not those receiving it at one month ( 101 % , -420 to 433 ) , was similar to the three-dose group .


4 years after vaccination of women aged 15-25 years , one and two doses of the HPV-16 / 18 vaccine seem to protect against cervical HPV-16 / 18 infections , similar to the protection provided by the three-dose schedule .


Two doses separated by 6 months additionally provided some cross-protection .


These data argue for a direct assessment of one-dose efficacy of the HPV-16 / 18 vaccine .


US National Cancer Institute , National Institutes of Health Office of Research on Women 's Health , and Ministry of Health of Costa Rica ( CVT ) ; GlaxoSmithKline Biologicals SA ( PATRICIA ) .


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 1 follow-up DXA measurement who had received 1 dose of either ZOL ( n = 55 ) or PLB ( n = 55 ) were included .


BMD was measured at LS , FN , TH , T-EPI , and T-DIA at baseline , 6 , 12 , 24 , and 36 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 36 months , BMD was significantly higher in women treated with ZOL vs. PLB at LS , FN , TH , and T-EPI ( +7.6 % , +3.7 % , +5.6 % , and +5.5 % , respectively , p < 0.01 for all ) but not T-DIA ( +1.1 % ) .


The number of patients with 1 incident non-vertebral or morphometric fracture did not differ between groups ( 9 ZOL/11 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 = 0.005 ) .


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 , 30 cases in each one .


In the auricular acupuncture group , acupuncture was applied bilaterally to gan ( CO12 ) and jiejie ( HX8 ) on the ears and needles were retained for 15 min .


After needle withdrawal , the vaccariae semen were fixed with plaster at naogan ( AT3 , 4i ) , zhen ( AT3 ) , jing ( AH12 ) , shen ( CO10 ) and pi ( CO13 ) on the ears .


In the medicine group , flunarizine hydrochloride capsules ( Sibelium ) , 5mg were prescribed for oral administration , once every night .


The treatment lasted continuously for 2 weeks ( 14 days ) in the two groups .


In 2 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 < 0.01 , P < 0.05 ) .


Compared with the medicine group , the reduced score was much more obvious in the auricular acupuncture group ( P < 0.05 ) , 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 < 0.05 ) .


But the difference was not significant between the two groups ( both P > 0.05 ) .


In comparison of clinical efficacy between the two groups , the effective rate was 93.3 % ( 28/30 ) in the acupuncture group and better than 76.7 % ( 23/30 ) in the medicine group , indicating the significant difference in comparison ( P < 0.05 ) .


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 116E strain .


Using broad screening criteria and active surveillance , the incidence of intussusception between 6 weeks and 2 years of age was measured in 4532 children who received three doses of vaccine and 2267 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 1361 evaluated sentinel events .


Eleven were of level 1 diagnostic certainty as determined by the independent intussusception case adjudication committee .


None required surgical intervention , and the earliest identified intussusception was at 36 days following the third dose in a placebo recipient .


Among vaccine recipients the first event of intussusception occurred 112 days after the third dose .


The incidence of ultrasound-diagnosed intussusception was 200/100 ,000 child-years ( 95 % CI , 120 , 320 ) among those receiving the vaccine and 141/100 ,000 child-years ( 95 % CI , 50 , 310 ) among those receiving the placebo .


The incidence rate of confirmed intussusception among vaccine recipients was 94/100 ,000 child-years ( 95 % CI , 41 , 185 ) and 71/100 ,000 child-years ( 95 % CI , 15 , 206 ) among those receiving the placebo .


In this licensure study , 23 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 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery .


Subjects 18 years of age who were scheduled for colorectal laparoscopy ( Mangram contamination class IIII ) within 8 weeks of selection were eligible , regardless of aetiology .


Participants were randomised 1:1 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 1 to 10 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 30 days following surgery .


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


Of those randomised to the HA/CMC powder ( n = 105 ) or no adhesion barrier ( n = 104 ) 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 ( 63 % vs. 39 % ; P < 0.001 ) , as were serious adverse events ( 28 % vs. 11 % ; P < 0.001 ) .


There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs ( 21 % vs. 14 % ; P = 0.216 ) and serious SSIs ( 12 % vs. 9 % ; P = 0.38 ) , or in the most frequent serious SSIs of pelvic abscess ( 5 % and 2 % ; significance not tested ) , anastomotic fistula ( 3 % and 4 % ) , and peritonitis ( 2 % and 3 % ) .


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 .


ClinicalTrials.gov NCT00813397 .


Registered 19 December 2008 .


We conducted this study to assess the immunologic effect of daily 20 mg zinc supplementation for 24 weeks in HIV-infected children older than 6 months receiving highly active antiretroviral therapy ( ART ) .


Fifty-two HIV-infected children older than 6 months in whom ART was initiated were randomized to receive either 20 mg of zinc or placebo for a period of 24 weeks .


Children underwent clinical examination , anthropometry , and laboratory evaluations : CD4 % and count , viral load , and serum zinc level at baseline , 12 weeks , and 24 weeks .


The primary outcome evaluated was CD4 % value at the end of 12 and 24 weeks of study intervention in the enrolled children .


Of 52 children enrolled , 49 completed the study .


The median CD4 % value rose from 10 % to 23 % at 12 weeks and to 24.5 % at 24 weeks in the zinc group , whereas in the placebo group , the value rose from 11 % to 20 % at 12 weeks and to 22 % at 24 weeks ( P = 0.188 for comparison between the zinc and the placebo group at 12 wk and P = 0.3 for comparison at 24 wk ) .


The median ( interquartile range ) log reductions in the viral load at 12 weeks in the 2 arms were similar at 12 ( P = 0.84 ) and 24 weeks ( P = 0.43 ) .


Supplementation of 20 mg zinc daily for 24 weeks did not have any statistically significant effect on the increase in CD4 % , decrease in viral load , anthropometric indices , and morbidity profile in HIV-infected children started on ART .


To investigate the effects of 4-month treatment of medroxyprogesterone acetate ( MPA ) and Diane-35 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 .


76 adolescents girls aged 14 to 19 years old with PCOS were recruited from July 2007 to July 2010 .


Girls were randomized into 2 groups .


Group 1 received oral MPA for 4 months , followed by a washout period of 4 months , and then Diane-35 for another 4 months .


Group 2 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 2 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-35 .


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


When comparing post-MPA and post-Diane-35 , the post-Diane-35 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-35 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 ( NCT00407043 ) .


Hundred and eighteen patients with dry eye disease were randomized to receive either LE and tCsA ( n = 61 ) or artificial tears ( AT ) and tCsA ( n = 57 ) .


Hundred and twelve patients completed the study ( LE : n = 57 , AT : n = 55 ) and are included in the data analysis .


Patients self-administered either LE or AT for 2 weeks 4 times per day , followed by tCsA twice per day accompanied by either LE twice per day or AT twice per day for an additional 6 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 < 0.05 ) .


Both groups showed significantly improved OSDI scores at the 14 - , 30 - , and 60-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 2 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 70,000 children and adolescents aged 7-18 years from 7 provinces in China .


In each center , about 12-16 primary and secondary schools , with totally at least 10000 participants were randomly selected ( Primary : Secondary = 1:1 ) .


All of the selected schools were randomly allocated to either intervention or control group ( Intervention : Control = 1:1 ) .


The multi-components school-based and family-involved scheme was conducted within the intervention group for 9month , 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 .


January 22 , 2015 ;


NCT02343588 .


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 110 patients with KOA who met the inclusion criteria .


These patients randomly received either active moxibustion ( n = 55 ) or sham moxibustion control ( n = 55 ) at acupoints Dubi ( ST 35 ) , extra-point Neixiyan ( EX-LE 4 ) , and an Ashi ( tender ) point three times a week for 6 weeks .


Effects were evaluated with Western Ontario and McMaster Universities ' Osteoarthritis Index ( WOMAC VA 3.1 ) criteria at the end of the course of treatment and 3 , 12 , and 24 weeks after the initial treatment .


The WOMAC pain scores showed greater improvement in the active treatment group than in control at weeks 3 ( P = 0.012 ) , 6 ( P < 0.001 ) , 12 ( P = 0.002 ) , and 24 ( P = 0.002 ) as did WOMAC physical function scores of the active treatment group at week 3 ( P = 0.002 ) , 6 ( P = 0.015 ) , and 12 ( P < 0.001 ) but not 24 ( P = 0.058 ) .


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


A 6-week course of moxibustion seems to relieve pain effectively and improve function in patients with KOA for up to 18 weeks after the end of treatment .


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


Current controlled trial : ISRCTN68475405 .


Registered 4 April 2014 .


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 ( 0.4 mg tamsulosin , 35 patients ) and the double dose group ( 0.4 mg tamsulosin + 10 mg alfuzosin , 35 patients ) .


The catheter was removed after 3 days , and the patients were put on trial without catheter ( TWOC ) .


Seventy males ( mean age , 71.2 years ) were randomly assigned to receive double or single dose alpha-blocker ( 35 patients per group ) .


The intent-to-treat population consisted of 70 males .


Twenty-seven individuals in the double dose group and 19 in the single dose group did not require re-catheterization on the day of the TWOC ( 77 % and 54 % , respectively ; P = .003 ) .


Success using free-flow variables was also higher in the males who received double dose alpha-blocker compared with single dose therapy ( 48 % vs. 40 % ; P = .017 ) .


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 1:1:1 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 5 cm , pseudoaneurysm , arteriovenous fistula , access-site-related bleeding , acute ipsilateral leg ischaemia , the need for vascular surgical/interventional treatment or documented local infection ) at 30 days after randomisation .


According to power calculations based on non-inferiority hypothesis testing , enrolment of 4,500 patients is planned .


The trial is registered at www.clinicaltrials.gov ( study identifier : NCT01389375 ) .


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


41 adults ( 32 F , 9 M ) with a mean SD age of 56.2 4.7 years and a BMI of 35.9 4.2 kg/m ( 2 ) .


Arch Height Index ( AHI ) , Malleolar Valgus Index ( MVI ) , spatial and temporal gait parameters , plantar peak pressure ( PP ) and weight were measured at baseline , 3 , and 6 months .


The intervention group experienced significantly greater weight loss than did the control group ( 5.9 4.0 kg versus 1.9 3.2 kg , p = 0.001 ) after 3 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 4 ( all p values < .05 ) at 3 months .


The change in PP correlated significantly with the change in weight at the metatarsal 2 ( r = 0.57 , p = 0.0219 ) , metatarsal 3 ( r = 0.56 , p = 0.0064 ) and the medial arch ( r = 0.26 , p < 0.0001 ) at 6 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 4 ( after 3 weeks treatment ) in an exploratory analysis of data from a randomized phase 2 study of motesanib 125 mg once daily plus carboplatin/paclitaxel and in a prespecified analysis of data from a randomized , double-blind phase 3 study of motesanib 125 mg once daily plus carboplatin/paclitaxel vs placebo plus carboplatin/paclitaxel ( MONET1 ) .


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


In the phase 2 study , serum placental growth factor increased from baseline a mean 2.8-fold at study week 4 .


Patients with 2.2-fold change from baseline in placental growth factor ( n = 18 ) had significantly longer overall survival than those with < 2.2-fold change ( n = 19 ; 22.9 vs 7.9 months ; hazard ratio , 0.30 ; 95 % CI , 0.12-0 .74 ; P = 0.009 ) .


Consequently , placental growth factor was investigated as a pharmacodynamic biomarker in the phase 3 MONET1 study .


There was no association between log-transformed placental growth factor fold-change from baseline to week 4 ( continuous variable ) and overall survival ( hazard ratio , 0.98 ; 95 % CI , 0.79-1 .22 ; P = 0.868 ) .


MONET1 did not meet its primary endpoint of overall survival .


Likewise , median overall survival was similar among patients with 2.0-fold change in placental growth factor ( n = 229 ) compared with < 2.0-fold change ( n = 127 ; 14.8 vs 13.8 months ; hazard ratio , 0.88 ; 95 % CI , 0.67-1 .15 , P = 0.340 ) .


Our results illustrate the challenges of successfully translating phase 2 biomarker results into phase 3 studies .


ClinicalTrials.gov NCT00460317 , NCT00369070 .


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 2 groups were compared .


iPhone application users scored significantly higher on their PRM performance compared with controls ( P < .0001 ) and performed the PRM significantly more slowly ( P < .0001 ) .


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 2-59 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 225 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 = 0.0001 ) than in younger ones .


Higher basal zinc concentration ( P = 0.011 ) and better height-for-age z score ( HAZ ) ( P = 0.044 ) were associated with faster resolution of chest indrawing .


Better weight-for-height z score ( WHZ ) ( P = 0.031 ) and HAZ ( P = 0.048 ) were associated with faster resolution of tachypnea .


Increased C-reactive protein was associated with a longer duration of tachypnea ( P = 0.044 ) .


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 409 patients undergoing cardiac operations enrolled in a trial conducted at 30 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 6 g/dL .


Transfusion was acceptable but not mandatory for hemoglobin 6 to 8 g/dL .


For hemoglobin 8 to 10 g/dL , transfusion was acceptable only with evidence for end-organ ischemia .


The patient population was moderately complex , with 20.5 % having combined procedures and 29.6 % having nonelective operations .


The mean EuroSCORE for the population was 4.3 , which predicted a substantial incidence of morbidity and mortality .


Actual outcomes were excellent , with observed mortality of 0.49 % and rates of cerebrovascular accident , myocardial infarction , and acute renal failure 1.2 % , 6.1 % , and 0.98 % , respectively .


The frequency of red blood cell transfusion was 33.7 % , which varied significantly by center .


Most transfusions ( 71.9 % ) were administered for hemoglobin 6 to 8g/dL ; 21.4 % were administered for hemoglobin 8 to 10g/dL with evidence for end-organ ischemia ; 65.0 % 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 43 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 24 weeks .


We compared data between patients who did and did not have at least 5 % decrease in body mass index ( BMI ) during the study period .


Ten of 43 patients had at least a 5 % 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 ( 18.3 % 7.6 % to 13.6 % 13.6 % , P = .03 ) , a relative 25.5 % reduction .


They also had a significant decrease in liver volume ( 5.3 % ) .


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


Thirty-three patients without at least 5 % decrease in BMI had insignificant increases in estimated liver fat fraction and liver volume .


A reduction in BMI of at least 5 % 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 ( 12weeks ) , high-dose glucocorticoids .


Prospective , randomized , controlled , single blind , interventional study conducted on 41 steroid-nave pre-pubertal children ( 29 boys , 12 girls ) .


All children received prednisolone for 12weeks ( 60mg/m ( 2 ) / day daily for 6weeks , followed by 40mg/m ( 2 ) / day alternate days for 6weeks ) .


Recruited children were randomized into the intervention group ( IG ; vitamin D 1,000 IU/day and elemental calcium 500mg/day ) and the control group ( CG ) .


Bone mineral content ( BMC ) and bone mineral density ( BMD ) at the lumbar spine ( L1-L4 ) were estimated at baseline and at 12weeks .


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


Children in the IG showed an increase of 11.2 % in BMC versus the CG , who showed an 8.9 % fall ( p < 0.0001 ) .


Net intervention-attributable difference in BMC was 20.1 % .


BMD increased in both groups ( IG 2.8 % vs CG 0.74 % ) , but the difference was not statistically significant ( p = 0.27 ) .


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 619 NSCLC patients in phases III and IV who were initially treated and re-treated were randomly divided into an NDP group ( n = 294 ) and a DDP group ( n = 325 ) , 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 48.6 % and 95.2 % , significantly higher than in the DDP group at 35.1 % and 89.2 % , respectively ( P < 0.01 ) .


In NSCLC patients with initial treatment , squamous carcinoma and phase III , there were significant differences in ORR and DCR between the groups ( P < 0.05 ) , while ORR was significant in patients with adenocarcinoma , GP/TP and in phase IIIa ( P < 0.05 ) .


There was also a significant difference in DCR in patients in phase IIIb ( P < 0.05 ) .


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 < 0.01 ) .


The rates of decreased hemoglobin and increased creatinine , nausea and vomiting in the NDP group were evidently lower than in DDP group ( P < 0.05 ) .


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 24-week randomized controlled trial of 303 patients with asthma in a real-world setting .


Prestudy use checks involved 2 actuations of the MDI , with a further 2 performed 2 hours later .


Within-study monitor checks , performed before dispensing at clinic visits 2 to 4 , 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 2728 monitors ( 98.2 % ) passed prestudy use checks .


Seventy-six of 2642 monitors ( 2.9 % ) dispensed to participants failed within-study monitor checks .


Fifty-one of 2642 monitors ( 1.9 % ) malfunctioned before data upload , mostly as a result of fluid immersion .


Ninety-three of 2642 monitors ( 3.5 % ) were lost or thrown away by participants .


Complete data was available from 2498 of 2642 dispensed monitors ( 94.5 % ) and 2498 of 2549 returned monitors ( 98.0 % ) .


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 ( 0.025 , 0.5 , 1.0 and 1.5 mA ) were examined up to 10 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 ( 16 cm2 and 35 cm2 ) .


In the equivalent current density condition , the current density was kept constant under both electrodes ( 0.014 , 0.029 and 0.043 mA/cm2 ) , whereas in the equal current intensity condition ( 0.5 , 1.0 and 1.5 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 35 cm2 to 16 cm2 .


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 368 adults with interstitial cystitis/bladder pain syndrome , defined as an ICSI total score of 8 or greater and a score of greater than 0 on the 4 ICSI component items , received pentosan polysulfate sodium 100 mg once daily or 3 times daily , or matching placebo for 24 weeks .


Study eligibility was not based on cystoscopy findings .


ICSI was administered at baseline , and at weeks 4 , 8 , 12 , 18 and 24 .


Unblinded interim analysis performed at 6 years with 54 % of the target number of 645 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 2 pentosan polysulfate sodium groups for the primary end point , defined as responder achieving a 30 % or greater reduction from the baseline ICSI total score at study end .


This primary end point was achieved by 48 of 118 patients ( 40.7 % ) in the placebo group , and by 51 of 128 ( 39.8 % ) and 52 of 122 ( 42.6 % ) in the pentosan polysulfate sodium 100 mg once daily and 3 times daily groups , respectively .


Pentosan polysulfate sodium was well tolerated with a similar percent of patients ( range 10.2 % to 13.3 % ) 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 = 250 ) 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 0.90 , and identification of OCT variables that predict postprocedure FFR .


Adverse cardiac events ( death , recurrent myocardial infarction , stent thrombosis , and repeat target lesion revascularization ) at 6 months will be recorded .


The DOCTORS randomized trial ( ClinicalTrials.gov NCT01743274 ) 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 2 units alternated between disposable and reusable ECG-LWs for 4 months .


A remote monitoring team , blinded to ECG-LW type , assessed frequency and type of alarm events by using total counts and rates per 100 patient days .


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


In 1611 patients and 9385.5 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 [ 95 % CI ] , 0.71 [ 0.53-0 .96 ] ; noninferiority P < .001 ; superiority P = .03 ) and monitoring ( artifact ) alarms were significantly noninferior ( adjusted relative risk [ 95 % CI ] : 0.88 , [ 0.62-1 .24 ] , P = .02 ; superiority P = .44 ) .


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 [ rate per 100 patient days ] , disposable 2029 [ 79.1 ] vs reusable 6673 [ 97.9 ] ; adjusted relative risk [ 95 % CI ] : 0.81 [ 0.63-1 .06 ] , P = .002 ; superiority P = .12 . )


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 3 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 3-month lower-dose flecainide regime on early and late recurrences of ATs .


We randomly assigned 126 patients , who underwent RFCA for AF , to the flecainide group ( 150 or 100 mg/day according to their body weight ) or to the control group receiving no AADs .


The primary endpoint was any AT lasting for 30 s during the first 3 months and the secondary endpoint was a composite of ATs lasting for 24 h or requiring cardioversion or hospitalization during the same period .


All AADs were stopped after the first 3 months and the late arrhythmia recurrences were also evaluated .


The primary endpoint rates were 37 and 41 % in the flecainide ( 143 19 mg/day ) and control groups , respectively ( log-rank P = 0.76 ) , and those of the secondary endpoint were 10 and 14 % , respectively ( log-rank P = 0.45 ) .


The estimated rates of maintaining sinus rhythm at 12 months after the first 3 months were 78 and 72 % , in the flecainide and control groups , respectively ( log-rank P = 0.68 ) , and the rates were 51 and 90 % in those with and without the primary endpoint , respectively ( log-rank P < 0.001 ) .


The 3-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 ( 10 subjects ) underwent intensive gait training with rhythmic auditory stimulation for a period of 6 weeks ( 30 min/day , five days/week ) , while those in the control group ( 10 subjects ) underwent intensive gait training for the same duration .


Two clinical measures , Berg balance scale and stroke specific quality of life scale , and a 2-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 3.3 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 0.454 % stannous-containing dentifrice as compared to a marketed negative control dentifrice after the first brushing as well as after 3 days and 2 weeks of twice daily use .


This was a 2-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 0.454 % stannous fluoride ( SnF2 ) 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 2-week period , with the same tactile and thermal efficacy evaluations repeated at Day 3 and Week 2 post-baseline .


All 116 enrolled subjects completed all evaluations .


The stannous fluoride dentifrice provided significantly ( P < 0.0001 ) 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 124.5 % after one use , 203.8 % after 3 days , and 222.5 % after 2 weeks ; and superior mean relative Schiff Air Index ( thermal ) benefits were 27.6 % after a single use , 44.6 % at Day 3 , and 74.2 % at Week 2 .


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 250 cases undergoing primary Cesarean section from January 2011 to June 2012 at our hospital were recruited .


They were randomly divided into experiment ( n = 130 ) and control ( n = 120 ) groups .


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