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[ "To compare the effects of massage therapy ( moderate pressure stroking ) and exercise ( flexion and extension of limbs ) on preterm infants ' weight gain and to explore potential underlying mechanisms for those effects .", "Weight gain and parasympathetic nervous system activity were assessed in 30 preterm infants randomly assigned to a massage therapy group or to an exercise group .", "Infants received 10min of moderate pressure massage or passive flexion and extension of the limbs 3 times per day for 5days , and EKGs were collected during the first session to assess vagal activity .", "Both massage and exercise led to increased weight gain .", "However , while exercise was associated with increased calorie consumption , massage was related to increased vagal activity .", "Taken together , these findings suggest that massage and exercise lead to increased preterm infant weight gain via different underlying mechanisms ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Studies have shown that cannabis intake increases the risk of traffic accidents .", "Controlled experiments support these findings and have shown a positive dose-effect relationship .", "In this retrospective cross-sectional study of data from a roadside survey , we investigated whether a police officer 's judgment regarding signs of impairment is related to the concentration of delta-9-tetrahydrocannabinol ( THC ) in the oral fluid ( OF ) .", "We investigated 2,632 cases from a representative sample of 3,302 Spanish drivers : 253 drivers positive for THC only , 32 positive for THC and ethanol , 201 with only ethanol detected in their breath , and 2,146 drivers who tested negative for ethanol in breath and drugs in OF .", "Recorded data comprised breath alcohol concentrations , THC concentrations in the OF , and the 31 observed signs of impairment .", "Subject groups were compared using the chi-square test , and logistic regression was used to examine the risk of being categorized as exhibiting signs of impairment .", "A relationship was found between the OF THC concentration and some observed signs of impairment .", "Eye signs were noticeable from a THC concentration > 3.0 ng/ml in OF , and > 25 ng/ml was related to behavior , facial expression , and speech signs .", "Alcohol and THC contribute to impairment independently and , when taken simultaneously , the effects are comparable to the sum of the effects when consumed separately .", "The observation of signs of impairment due to cannabis occurs in an OF concentration-related manner but , as a clinical test , OF has low sensitivity and specificity in a random roadside survey ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Long-term effects of different weightbearing ( WB ) modalities after matrix-associated autologous chondrocyte implantation ( MACI ) on changes in knee articular cartilage and clinical outcomes are needed to establish more evidence-based recommendations for postoperative rehabilitation .", "There will be no differences between accelerated WB compared with delayed WB regarding knee articular cartilage or patient self-reported knee function or activity level 5 years after MACI .", "Furthermore , significant correlations between magnetic resonance imaging ( MRI ) - based outcomes and patient-reported outcome measures 5 years postoperatively will exist .", "Randomized controlled trial ; Level of evidence , 1 .", "After MACI , 31 patients ( 23 male , 8 female ) were randomly assigned to the accelerated WB group ( AWB group ) or to the delayed WB group ( DWB group ) .", "With the exception of time and increase to full WB , both groups underwent the same rehabilitation program .", "The AWB group was allowed full WB after 6 weeks and the DWB group after 10 weeks .", "Assessments were performed 3 months , 2 years , and 5 years postoperatively , but this long-term follow-up study only included changes from 2 to 5 years postoperatively .", "The magnetic resonance observation of cartilage repair tissue ( MOCART ) score ( primary outcome ) , the MRI-based variables of bone edema and effusion , the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) , and the Tegner scale were included .", "In addition , the association between MRI-based outcomes and the KOOS at 5 years postoperatively was investigated .", "There was a significant decrease in the MOCART score and a significant increase in bone edema 2 and 5 years postoperatively but no significant group differences .", "The only significant correlation between the MRI-based variables and the KOOS was found for bone edema and the KOOS subscale of pain ( r = -0.435 , P < .05 ) at 5-year follow-up .", "There were no significant differences in the MRI-based or clinical outcomes between the AWB group and DWB group 5 years after MACI .", "While the clinical outcomes remained stable , a decline of the MRI-based findings was observed between 2 and 5 years postoperatively .", "Furthermore , a significant association between bone edema and pain was found .", "No occurrence of unintended effects was observed ." ]

[ "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To determine the effects of rivastigmine patch associated with physical exercise versus rivastigmine patch alone in quality of life ( QOL ) , cognition , activities of daily living ( ADL ) and functional mobility in Alzheimer 's disease ( AD ) subjects .", "A randomized , controlled , single-blinded trial was conducted in 40 patients with mild to moderate stages of AD .", "All patients were daily treated with rivastigmine transdermal patch at a stable dose of 4.6 mg and randomized into two groups : physical exercises or control .", "The exercise program consisted of aerobic , flexibility , strength and balance movements , twice a week for 6 months .", "Main outcomes were Quality of Life in Alzheimer 's disease scale ( QOL ) , Activities of Daily Living Questionnaire ( ADL ) , Mini-Mental State Examination ( MMSE ) and `` Time Up and Go Test '' .", "Thirty-four patients completed the study .", "After 6 months , there was a significant improvement in QOL of patients randomized to physical exercise group ( P < 0.05 ) .", "In both groups , there was an improvement on caregivers QOL ( P > 0.05 ) .", "When considering cognitive functions , there was no difference between groups .", "The ability to perform ADL worsened in the group enrolled to RTP alone .", "There was an improvement in functional mobility in the group treated with RTP .", "Our results suggest that the association between physical exercises and RTP improves QOL in patients with AD .", "Cognition remained unchanged in both groups .", "Regarding the effect of physical exercises in ADL , further trials are necessary to confirm these results ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Immobilization of the spine of patients with trauma at risk of spinal damage is usually performed using a rigid long spineboard or vacuum mattress , both during prehospital and in-hospital care .", "However , disadvantages of these immobilization devices in terms of discomfort and tissue-interface pressures have guided the development of soft-layered long spineboards .", "We compared tissue-interface pressures between awake and anaesthetized ( unconscious ) patients during immobilization on a rigid spineboard and a soft-layered long spineboard .", "In this comparative study , 30 anaesthetized patients were randomized to immobilization on either the rigid spineboard or the soft-layered spineboard for the duration of their elective surgery .", "Tissue-interface pressures measured using an Xsensor pressure-mapping device were compared with those of 30 healthy volunteers who were immobilized sequentially on the rigid spineboard and the soft-layered spineboard .", "Redness of the sacrum was also recorded for the anaesthetized patients immediately after the surgery .", "For both anaesthetized patients and awake volunteers , tissue-interface pressures were significantly lower on the soft-layered spineboard than on the rigid spineboard , both at start and after 15min .", "On the soft-layered spineboard , tissue interface pressure and peak pressure index ( PPI ) for the sacrum were significantly lower for anaesthetized patients than for awake volunteers .", "Peak pressures and PPI on the rigid spineboard were equal for both groups .", "Tissue-interface pressures did not change significantly over time .", "Redness of the sacrum was significantly more pronounced on the rigid spineboard than on the soft-layered spineboard .", "This prospective randomized controlled trial shows that using a soft-layered spineboard compared to a rigid spineboard for spinal immobilization resulted in lower tissue-interface pressures in both awake volunteers and anaesthetized patients .", "Moreover , tissue-interface pressures on the soft-layered spineboard were lower in anaesthetized patients than in awake volunteers .", "These findings show the importance of using a soft-layered spineboard to reduce tissue-interface pressure , especially for patients who can not relieve pressure themselves by changing position ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Few studies have designed and tested the use of continuous quality improvement approaches in community based substance use treatment settings .", "Little is known about the feasibility , costs , efficacy , and sustainment of such approaches in these settings .", "A group-randomized trial using a modified stepped wedge design is being used .", "In the first phase of the study , eight programs , stratified by modality ( residential , outpatient ) are being randomly assigned to the intervention or control condition .", "In the second phase , the initially assigned control programs are receiving the intervention to gain additional information about feasibility while sustainment is being studied among the programs initially assigned to the intervention .", "By using this design in a pilot study , we help inform the field about the feasibility , costs , efficacy and sustainment of the intervention .", "Determining information at the pilot stage about costs and sustainment provides value for designing future studies and implementation strategies with the goal to reduce the time between intervention development and translation to real world practice settings ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "One of the main priorities of Dutch organisations providing shelter services is to develop evidence-based interventions in the care for abused women and homeless people .", "To date , most of these organisations have not used specific intervention models and the interventions which have been implemented rarely have an empirical and theoretical foundation .", "The present studies aim to examine the effectiveness of critical time intervention ( CTI ) for abused women and homeless people .", "In two multi-centre randomised controlled trials we investigate whether CTI , a time-limited ( nine month ) outreach intervention , is more effective than care-as-usual for abused women and homeless people making the transition from shelter facilities to supported or independent housing .", "Participants were recruited in 19 women 's shelter facilities and 22 homeless shelter facilities across The Netherlands and randomly allocated to the intervention group ( CTI ) or the control group ( care-as-usual ) .", "They were interviewed four times in nine months : once before leaving the shelter , and then at three , six and nine months after leaving the shelter .", "Quality of life ( primary outcome for abused women ) and recurrent loss of housing ( primary outcome for homeless people ) as well as secondary outcomes ( e.g. care needs , self-esteem , loneliness , social support , substance use , psychological distress and service use ) were assessed during the interviews .", "In addition , the model integrity of CTI was investigated during the data collection period .", "Based on international research CTI is expected to be an appropriate intervention for clients making the transition from institutional to community living .", "If CTI proves to be effective for abused women and homeless people , shelter services could include this case management model in their professional standards and improve the ( quality of ) services for clients .", "NTR3463 and NTR3425 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Eye irritation is a constant hazard for migrant and seasonal farmworkers , but there are few studies of the problem or how to address it .", "Researchers evaluated the effect of a community-based participatory eye health intervention on farmworker eye symptoms in the Hudson Valley , NY .", "A randomized pre-post intervention with 2 , 4-week follow-up periods was implemented with a sample of 97 farmworkers .", "Five eye symptoms were measured , along with utilization of protective eyewear and eye drops .", "Leading baseline eye symptoms were redness ( 49 % ) , blurred vision ( 43 % ) , itching ( 43 % ) , and eye pain ( 29 % ) .", "Significant reductions in eye pain ( P = 0.009 ) , and non-significant reductions in redness were observed for the intervention group while controls experienced increases in both .", "The intervention was effective in significantly reducing eye pain , and to a lesser extent , redness .", "Future eyewear promotion programs should offer a range of eye wear , tailor offerings to local climate and tasks , evaluate eyewear durability , and include eye drops ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Treatments for papulopustular rosacea ( PPR ) are limited .", "To demonstrate the efficacy and safety of once-daily ivermectin 1 % cream in subjects with moderate to severe PPR .", "Two identically designed , randomized , double-blind , controlled studies of ivermectin 1 % cream ( IVM 1 % ) or vehicle once daily for 12 weeks were conducted in subjects with moderate to severe PPR .", "Efficacy assessments were Investigator 's Global Assessment ( IGA ) of disease severity and inflammatory lesion counts .", "Safety assessments included incidence of adverse events ( AEs ) and local tolerance parameters .", "Subjects evaluated their rosacea and completed satisfaction and quality of life ( QoL ) questionnaires .", "In both studies , a greater proportion of subjects in the IVM 1 % group achieved treatment success ( IGA `` clear '' or `` almost clear '' ) : 38.4 % and 40.1 % vs 11.6 % and 18.8 % for vehicle ( both P < .001 ) , respectively .", "Ivermectin was superior to vehicle in terms of reduction from baseline in inflammatory lesion counts ( 76.0 % and 75.0 % vs 50.0 % for both vehicle groups , respectively ) .", "For all endpoints , starting at week 4 and continuing through week 12 , IVM 1 % was statistically significantly superior ( P < .001 ) .", "Fewer subjects treated by IVM 1 % reported dermatologic AEs , and a higher proportion of subjects were observed to have no skin dryness or itching compared to vehicle .", "Significantly more subjects receiving IVM 1 % reported having an `` excellent '' or `` good '' improvement , along with an improved QoL .", "Ivermectin 1 % cream was effective and safe in treating inflammatory lesions of papulopustular rosacea ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To determine whether a novel endpoint of time to prerandomization monthly seizure count could be used to differentiate efficacious and nonefficacious therapies in clinical trials of new add-on antiepileptic drugs ( AEDs ) .", "This analysis used data from 3 randomized , double-blind , placebo-controlled phase III trials of perampanel as an add-on therapy in patients with epilepsy who were experiencing refractory partial seizures : studies 304 ( ClinicalTrials.gov identifier NCT00699972 ) , 305 ( NCT00699582 ) , and 306 ( NCT00700310 ) .", "Time to prerandomization monthly seizure count was evaluated post hoc for each trial , and findings were compared with the original primary outcomes ( median percent change in seizure frequency and 50 % responder rate ) .", "Outcomes were assessed for all partial-onset seizures , secondarily generalized ( SG ) tonic-clonic seizures only , and complex partial plus SG ( CP + SG ) seizures .", "Perampanel 4-12 mg significantly prolonged median time to prerandomization monthly seizure count , generally by more than 1 week , compared with placebo , across all 3 studies , consistent with the original primary outcomes .", "Analysis of SG seizures only , and CP + SG seizures , also indicated a significantly prolonged median time to prerandomization monthly seizure count with perampanel 8 mg and 12 mg compared with placebo .", "Time to prerandomization monthly seizure count is a promising novel alternative to the standard endpoints of median percent change in seizure frequency and 50 % responder rates used in trials of add-on AEDs .", "Use of this endpoint could reduce exposure to placebo or ineffective treatments , thereby facilitating trial recruitment and improving safety ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Patients are at risk of drug-related problems ( DRPs ) at transition points during hospitalization .", "The community pharmacist ( CP ) is often the first healthcare professional patients visit after discharge .", "CPs lack sufficient information about the patient and so they may be unable to identify problems in medications , which may lead to dispensing the wrong drugs or dosage , and/or giving wrong information .", "We aim to assess the impact of a complex intervention comprising of medication reconciliation performed at discharge by a hospital pharmacist ( HP ) with communication between the HP and CP on DRPs during the seven days following discharge .", "The study is a cluster randomized crossover trial involving 46 care units ( each unit corresponding to a cluster ) in 22 French hospitals during two consecutive 14-day periods , randomly assigned as ` experimental ' or ` control ' ( usual care ) periods .", "We will recruit patients older than 18 years of age and visiting the same CP for at least three months .", "We will exclude patients with a hospital length of stay of more than 21 days , who do not return home or those in palliative care .", "During the experimental period , the HP will perform a medications reconciliation that will be communicated to the patient .", "The HP will inform the patient 's CP about the patient 's drug therapy ( modification in home medication , acute drugs prescribed , nonprescription treatments , and/or lab results ) .", "The primary outcome will be a composite outcome of any kind of drug misuse during the seven days following discharge assessed at day seven ( 2 ) post-discharge by a pharmacist in charge of the study who will contact both patients and CPs by phone .", "The secondary outcome will be unplanned hospitalizations assessed by phone contact at day 35 ( 5 ) after discharge .", "We plan to recruit 1,176 patients .", "This study will assess the impact of a reconciliation of medications performed at patient discharge followed by communication between the HP and the patient 's CP .", "It will allow for identifying the type of patients in France for which the intervention is most relevant .", "This study was registered with ClinicalTrials.gov ( number : NCT02006797 ) on 5 December 2013 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The current efforts of intensivists focused on individual antibiotic treatment in patients suffering from sepsis has inspired us to conduct an open prospective clinical study to assess the relationship between body fluid retention ( > 10 L/24 hours ) and the efficiency of hydrophilic time-dependent antibiotics used in critically ill patients .", "Polytrauma and abdominal catastrophes are the most frequent causes of systemic inflammatory response syndrome ( SIRS ) .", "Consequent body liquid retention is taken for a pathophysiological covariate modifying the pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of hydrophilic time-dependent antibiotics ( betalactams and carbapenems ) .", "Not only body fluid retention but also changes in renal clearance are thought to be responsible for failure in PK/PD target attainment necessary for effective antimicrobial activity .", "To describe the importance of the pathophysiological covariates for the individual kinetic variables of a representative antibiotic ( piperacillin ) is the primary goal of this kinetic observational study .", "Three patients with polytrauma and SIRS admitted at the ICU of the Surgical Department , Teaching Hospital Hradec Krlov , whose condition was characterized by cumulative body fluid retention ( > 10 L ) , were eligible for enrolment .", "As per standard hospital protocol , the patients were administered with 4 g of piperacillin in combination with tazobactam 0.5 g intravenously by 1-hour ( h ) infusion every 8 h.", "A series of blood samples were taken 1 , 2.5 , and 5 h after the termination of the infusion .", "Urine was collected over each dosing interval and for 24 h. Piperacillin was detected using a previously validated HPLC method .", "Individual pharmacokinetic variables were estimated using non-compartmental pharmacokinetic analysis .", "Cumulative body fluid retention was calculated as the difference between fluid intake and output .", "Creatinine clearance ( Cl ) was used for renal function evaluation .", "PK/PD target attainment was analysed according to Carlier ( 2013 ) .", "In three patients with polytrauma and SIRS , great interindividual and intraindividual differences in extravascular volume expansion , i.e. cumulative body fluid retention 2030 L and changes in renal function , were recorded .", "In 2/3 patients these pathophysiological changes as well as the clinical interventions administered resulted in augmented piperacillin clearance and an increase in distribution volume ( Vd ) ( > 20 L ) with a maximum at Day 28 after initiation of therapy .", "In such patients treated with a standard dose of piperacillin , only minimum PK/PD target attainment ( 50 % Ft > MIC ) was obtained .", "In contrast , a patient suffering from renal dysfunction attained both minimum ( 50 % ft > MIC ) and maximum PK/PD target ( 100 % ft > MIC ) .", "In three critically ill patients with polytrauma and SIRS , pathophysiological changes ( covariates ) had a profound effect on the key determinants of the pharmacokinetics ( Cl and Vd ) , resulting in significant intraindividual variability in pharmacodynamic / pharmacokinetic target attainment necessary for therapeutic time-dependent antibacterial activity of piperacillin .", "Consequently , patients with augmented clearance of piperacillin may be at risk for treatment failure , and/or bacterial resistance without dose up-titration .", "A subsequent clinical study will be conducted to describe personalised kinetically guided antibiotic therapy ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Intracranial atherosclerosis represents a relatively unexplored , but potentially important , cause of stroke in a white population .", "To investigate the relationship between intracranial carotid artery calcification ( ICAC ) as a marker of intracranial atherosclerosis and the risk of stroke in whites .", "A population-based cohort study in the general community with 6 years of follow-up was conducted ( the Rotterdam Study ) .", "Between 2003 and 2006 , a random sample of 2323 stroke-free persons ( mean age , 69.5 years ) underwent computed tomography scanning to quantify ICAC volume .", "All participants were continuously monitored for the occurrence of stroke until January 1 , 2012 .", "Atherosclerotic calcification in the intracranial internal carotid arteries .", "Incident stroke .", "During 14,055 person-years of follow-up , 91 participants had a stroke , of which 74 were ischemic .", "Larger ICAC volume was related to a higher risk of stroke , independent of cardiovascular risk factors , ultrasound carotid plaque score , and calcification in other vessels ( fully adjusted hazard ratio per an increase of 1 SD in ICAC volume , 1.43 [ 95 % CI , 1.04-1 .96 ] ) .", "Intracranial carotid artery calcification contributed to 75 % of all strokes ; for aortic arch and extracranial carotid artery calcification this incidence was only 45 % and 25 % , respectively .", "Our findings establish intracranial atherosclerosis as a major risk factor for stroke in the general white population and suggest that its contribution to the proportion of all strokes may be greater than that of large-artery atherosclerosis in more proximally located vessel beds ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Transient esophageal ulceration is a common finding after sclerotherapy of varices .", "These ulcers sometimes cause pain , ulcer bleeding , and stricture formation .", "Gastroesophageal reflux ( GER ) after Endoscopic injection sclerotherapy ( EIS ) is a known cause of worsening ulcer formation .", "Therefore , an efficient drug for GER is desirable to improve the quality of life of patients with esophageal varices .", "We randomized 18 Japanese cirrhotic patients who had risky esophageal varices .", "The patients were randomly allocated into two groups , and during EIS sessions , one group was administered proton pump inhibitor ( PPI ) ( Rabeprazole 20 mg a person once a day ) , while the other received histamine H2 receptor antagonist ( H2-blocker ) ( famotidine 20 mg a person , twice a day ) .", "Gastroesophageal reflux was monitored by a 24-h pH-monitoring catheter introduced into the distal esophagus .", "Ulcer formation was evaluated using an endoscopic examination .", "The subjective and objective symptoms were also compared between the two groups .", "All patients in the H2-blocker group showed an increased percentage of time with pH < 4.0 after EIS sessions , but no patients in the PPI group showed an increased such symptoms .", "The H2-blocker group also experienced a significantly higher number of days of heartburn and dysphasia than did the PPI group ( p = 0.017 , p = 0.042 ) .", "The rate of ulcer improvement was found to be faster in Rabeprazole group than in H2 blocker group ( p = 0.008 ) .", "These results suggest that Rabeprazole treatment prevents EIS-associated gastroesophageal reflux and promotes ulcer healing .", "Rabeprazole also improve the subjective symptoms following EIS ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To evaluate the efficacy and safety of gatifloxacin 0.5 % ophthalmic solution administered twice daily for treatment of acute bacterial conjunctivitis .", "Two identically designed , double-masked , multicenter studies in the United States and India enrolled patients 1 year or older with acute bacterial conjunctivitis .", "Patients were randomized to gatifloxacin 0.5 % or vehicle treatment for 5 days .", "Clinical success in clearing conjunctival hyperemia and discharge at day 6 ( primary endpoint ) and day 4 and microbiological cure were determined .", "Isolates from positive conjunctival samples were tested for sensitivity and susceptibility .", "Safety measures included adverse events ( AEs ) .", "Data from these 2 studies were pooled for these analyses .", "Of the 1437 randomized patients , 658 constituted the modified intent-to-treat population .", "Patient characteristics were similar between the pooled treatment groups .", "Clinical success occurred for 58.0 % of gatifloxacin 0.5 % - treated versus 45.5 % vehicle-treated patients at day 6 ( P = 0.001 ) and for 23.7 % versus 15.4 % in the respective groups at day 4 ( P = 0.007 ) .", "Microbiological cure was higher with gatifloxacin 0.5 % than vehicle at days 4 and 6 ( P < 0.001 for both time points ) .", "The combined minimum inhibitory concentration required to inhibit 90 % of isolates for gatifloxacin 0.5 % was 2.0 g/mL for gram-positive and gram-negative organisms .", "AEs were reported by 11.6 % and 13.3 % of patients in the gatifloxacin 0.5 % and vehicle safety populations , respectively .", "One patient in each treatment group experienced a serious AE ; neither was treatment related .", "The 0.5 % concentration of gatifloxacin ophthalmic solution was safe and effective for treatment of acute bacterial conjunctivitis with twice-daily administration for 5 days ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Reduced postoperative pain is considered one of the benefits of laparoscopic inguinal hernia repair ( LHR ) .", "We investigated the need for intravenous flurbiprofen axetil ( FA ) before emergence from anesthesia in patients who had undergone LHR .", "Forty adult patients who were prepared for LHR were randomly divided into the FA group ( FA 1 mg x kg ( -1 ) administered at the end of surgery , n = 20 ) and the control group ( no FA administration , n = 20 ) .", "Postoperative pain was evaluated by the Prince Henry Pain Score ( PHPS ) as well as by the frequency of on-demand use of nonsteroidal antiinflammatory drugs ( NSAIDs ) .", "The PHPS on arrival at the ward was significantly lower in the FA group than the control group .", "Additionally , none of the patients of the FA group required NSAIDs in the first two hours of postoperative period , compared with 6 patients ( 30 % ) of the control group .", "However , at 4 hours postoperatively , none of the patients of both groups suffered pain at rest and the PHPS was similar in the two groups .", "Although postoperative pain after LHR is mild and disappears rapidly , FA administration before emergence from anesthesia is necessary for management of pain during the immediate postoperative period ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The aim of this study was to evaluate the efficacy and safety of combinations of lercanidipine ( L ) and enalapril ( E ) at different doses on office and home blood pressure ( BP ) in patients with Stage 2 hypertension .", "This was a randomized , double-blind , placebo-controlled , factorial study conducted in 100 centres from seven countries .", "Patients with office DBP 100-109mmHg and home DBP at least 85mmHg at the end of a 2-week placebo run-in period were randomized to a 10-week treatment with placebo , L ( 10 or 20mg ) , E ( 10 or 20mg ) or the four L-E combinations .", "The efficacy parameters were office DBP at trough ( primary ) , SBP at trough and home SBP and DBP .", "Office BP was measured at each visit in both the sitting and the standing position , while home BP was measured twice in the morning and twice in the evening for at least 3 days before treatment and at study end .", "Safety parameters included adverse events , laboratory tests and 12-lead ECG .", "A total of 1039 patients were randomized ( 48 % men , mean age 54 years , mean BMI 30kg/m , 40 % obese patients ) .", "Baseline BP was similar in all groups and lower for home than for office values ( 149/95 and 159/103mmHg , respectively ) .", "A marked placebo effect was observed on office but not on home BP .", "Combination therapy was superior to placebo at all doses for both office and home BP .", "The greatest effect was observed in the L20/E20 group , in which the SBP/DBP fall amounted to -19.2 / -15.2 and -13.2 / -7.5 mmHg for sitting office and home BP , respectively .", "Similar reductions were observed on standing office BP .", "The L20/E20 combination was associated with less cough , palpitations and leg oedema than monotherapies , with no increased rate of dizziness or hypotension .", "In Stage 2 hypertension , a fixed-dose combination of L and E ensures a control of both office and out-of-office BP , with a favourable tolerability profile ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Successful preventive therapy for ischemic priapism , a disorder of penile erection with major physical and psychologic consequences , is limited .", "We conducted a randomized , double-blind , placebo-controlled clinical trial to assess the efficacy and safety of sildenafil by a systematic dosing protocol to prevent recurrent ischemic priapism associated with sickle cell disease .", "Thirteen patients with sickle cell disease reporting priapism recurrences at least twice weekly were randomized to receive sildenafil 50 mg or placebo daily , unassociated with sleep or sexual activity , for 8 weeks , followed by open-label use of this sildenafil regimen for an additional 8 weeks .", "Priapism frequency reduction by 50 % did not differ between sildenafil and placebo groups by intention-to-treat or per protocol analyses ( P = 1.0 ) .", "However , during open-label assessment , 5 of 8 patients ( 62.5 % ) by intention-to-treat analysis and 2 of 3 patients ( 66.7 % ) by per protocol analysis met this primary efficacy outcome .", "No significant differences were found between study groups in rates of adverse effects , although major priapism episodes were decreased 4-fold in patients monitored `` on-treatment . ''", "Sildenafil use by systematic dosing may offer a strategy to prevent recurrent ischemic priapism in patients with sickle cell disease ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Goal of the presented study is to evaluate whether alcohol-dependent patients given additional individual psychotherapy after a heavy relapse during pharmacotherapy remain abstinent for longer than those who continue with pharmacotherapy alone .", "In a randomized , multicenter study , 109 alcohol-dependent patients who had suffered a heavy relapse either while receiving anticraving medication or placebo were randomized into 2 groups .", "One group received medication , medical management , and additional individual , disorder-specific , cognitive-behavioral psychotherapy , while the control group received medication and medical management only .", "Main outcome was defined as days until first heavy relapse .", "Fifty-four patients were randomized to the psychotherapy group , 55 to the control group .", "Intention-to-treat and completer analyses found no differences between groups , whereas as-treated analyses ( patients who actually received psychotherapy compared with those who did not ) found a significant effect of psychotherapy .", "Our data indicate that patients that are willing to attend psychotherapy benefit from receiving psychotherapy in addition to pharmacotherapy .", "We suggest that it may be beneficial to consider patients ' preferences concerning psychotherapy at an earlier stage during treatment ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Nonalcoholic fatty liver disease ( NAFLD ) is the most common cause of chronic liver injury .", "Chronic exposure to oxidative stress leads to depletion of liver antioxidants and abnormal cytokine production ; antioxidant therapy is one of the main therapeutic lines in NAFLD .", "In the current study we aimed to investigate the effect of coenzyme Q10 ( coQ10 ) therapy on several adipocytokines and insulin resistance in patients with NAFLD .", "In the current randomized double-blind placebo controlled trial 44 NAFLD patients were enrolled .", "After randomization into two groups , 22 patients received 100 mg/day coQ10 capsules and 22 patients received placebo daily for 4 weeks .", "BMI and WHR were calculated for patients at the beginning and end of the study and blood samples were obtained from the patients to measure serum concentrations of aspartate aminotransferase ( AST ) , alanine aminotransferase ( ALT ) , fasting serum glucose ( FSG ) , insulin resistance ( IR ) , vaspin , chemerin , pentraxin 3 ( PTX3 ) and markers of oxidative stress including total antioxidant capacity ( TAC ) and malondialdehyde ( MDA ) .", "After 4 weeks of coQ10 supplementation , waist circumference ( WC ) and serum AST and TAC concentrations significantly decreased in intervention group ( p < 0.05 ) but no significant changes occurred in placebo-treated group .", "In stepwise multivariate linear regression model , change in serum FSG was a significant predictor of changes in serum vaspin , chemerin and pentraxin 3 ( p < 0.001 ) .", "The present study showed a potential for coQ10 therapy in improving several anthropometric and biochemical variables in NAFLD .", "Longer studies with higher doses of coQ10 are required to further evaluate this potential benefit ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers , when supervised by specialists , in low-income and middle-income countries .", "We did the COmmunity care for People with Schizophrenia in India ( COPSI ) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care .", "We did a multicentre , parallel-group , randomised controlled trial at three sites in India between Jan 1 , 2009 and Dec 31 , 2010 .", "Patients aged 16-60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases , Diagnostic Criteria for Research ( ICD-10-DCR ) were randomly assigned ( 2:1 ) , via a computer-generated randomisation list with block sizes of three , six , or nine , to receive either collaborative community-based care plus facility-based care or facility-based care alone .", "Randomisation was stratified by study site .", "Outcome assessors were masked to group allocation .", "The primary outcome was a change in symptoms and disabilities over 12 months , as measured by the positive and negative syndrome scale ( PANSS ) and the Indian disability evaluation and assessment scale ( IDEAS ) .", "Analysis was by modified intention to treat .", "This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN 56877013 .", "187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group ; 253 ( 90 % ) participants completed follow-up to month 12 .", "At 12 months , total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group ( PANSS adjusted mean difference -3.75 , 95 % CI -7.92 to 0.42 ; p = 0.08 ; IDEAS -0.95 , -1.68 to -0.23 ; p = 0.01 ) .", "However , no difference was shown in the proportion of participants who had a reduction of more than 20 % in overall symptoms ( PANSS 85 [ 51 % ] in the intervention group vs 44 [ 51 % ] in the control group ; p = 0.89 ; IDEAS 75 [ 48 % ] vs 28 [ 35 % ] ) .", "We noted a significant reduction in symptom and disability outcomes at the rural Tamil Nadu site ( -9.29 , -15.41 to -3.17 ; p = 0.003 ) .", "Two patients ( one in each group ) died by suicide during the study , and two patients died because of complications of a road traffic accident and pre-existing cardiac disease .", "18 ( 73 % ) patients ( 17 in the intervention group ) were admitted to hospital during the course of the trial , of whom seven were admitted because of physical health problems , such as acute gastritis and vomiting , road accident , high fever , or cardiovascular disease .", "The collaborative community-based care plus facility-based care intervention is modestly more effective than facility-based care , especially for reducing disability and symptoms of psychosis .", "Our results show that the study intervention is best implemented as an initial service in settings where services are scarce , for example in rural areas .", "Wellcome Trust ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Complications with IV patient-controlled analgesia include programming errors , invasive access , and impairment of mobility .", "This study evaluated an investigational sufentanil sublingual tablet system ( SSTS ) for the management of pain after knee or hip arthroplasty .", "This prospective , randomized , parallel-arm , double-blind study randomized postoperative patients at 34U .", "S. sites to receive SSTS 15 g ( n = 315 ) or an identical placebo system ( n = 104 ) and pain scores were recorded for up to 72h .", "Adult patients with American Society of Anesthesiologists status 1 to 3 after primary total unilateral knee or hip replacement under general anesthesia or with spinal anesthesia that did not include intrathecal opioids were eligible .", "Patients were excluded if they were opioid tolerant .", "The primary endpoint was the time-weighted summed pain intensity difference to baseline over 48h .", "Secondary endpoints included total pain relief , patient and healthcare professional global assessments , and patient and nurse ease-of-care questionnaires .", "Summed pain intensity difference ( standard error ) was higher ( better ) in the SSTS group compared with placebo ( 76 [ 7 ] vs. -11 [ 11 ] , difference 88 [ 95 % CI , 66 to 109 ] ; P < 0.001 ) .", "In the SSTS group , more patients and nurses responded `` good '' or `` excellent '' on the global assessments compared with placebo ( P < 0.001 ) .", "Patient and nurse ease-of-care ratings for the system were high in both groups .", "There was a higher incidence of nausea and pruritus in the SSTS group .", "SSTS could be an effective patient-controlled pain management modality in patients after major orthopedic surgery and is easy to use by both patients and healthcare professionals ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Adherence to pharmacological or non-pharmacological treatment of diabetes type 2 is fundamental in order to delay the onset of complications .", "To measure the effect of nursing educational support on compliance with treatment in patients with type 2 diabetes attending Regional Hospital Universitario of Colima , Mexico .", "An experimental , randomized study including outpatients with type 2 diabetes attending a Regional Hospital who agreed in writing to participate in the study .", "Nursing educational intervention sessions of three hours on two days a week for three months were provided .", "Adherence to treatment was assessed before and after intervention using the Scale for treatment adherence in type 2 diabetes ( EATDM-III ( ) ) .", "We performed two-proportion Z and p ; Risk Ratio and confidence interval 95 % and attributable fraction exposed .", "e experimental group had 32 members , the same as the control .", "After the intervention it was found that 16 members ( 50 % ) in the experimental group showed treatment adherence , unlike the control group where no one showed adherence to treatment , obtaining an independent two-proportion Z = 4.62 , P = .0000 , Risk Ratio = 65 ; Confidence Interval 95 % = 3.67 to 1152.38 ; exposed attributable fraction = 98.46 % .", "The intervention was effective for the adherence of treatment ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "We report the main results , among adults , of a cluster-randomised-trial of Well London , a community-engagement programme promoting healthy eating , physical activity and mental well-being in deprived neighbourhoods .", "The hypothesis was that benefits would be neighbourhood-wide , and not restricted to intervention participants .", "The trial was part of a multicomponent process/outcome evaluation which included non-experimental components ( self-reported behaviour change amongst participants , case studies and evaluations of individual projects ) which suggested health , well-being and social benefits to participants .", "Twenty matched pairs of neighbourhoods in London were randomised to intervention/control condition .", "Primary outcomes ( five portions fruit/vegetables/day ; 530m of moderate intensity physical activity/week , abnormal General Health Questionnaire ( GHQ ) -12 score and Warwick-Edinburgh Mental Well-being Scale ( WEMWBS ) score ) were measured by postintervention questionnaire survey , among 3986 adults in a random sample of households across neighbourhoods .", "There was no evidence of impact on primary outcomes : healthy eating ( relative risk [ RR ] 1.04 , 95 % CI 0.93 to 1.17 ) ; physical activity ( RR :1.01 , 95 % CI 0.88 to 1.16 ) ; abnormal GHQ12 ( RR :1.15 , 95 % CI 0.84 to 1.61 ) ; WEMWBS ( mean difference [ MD ] : -1.52 , 95 % CI -3.93 to 0.88 ) .", "There was evidence of impact on some secondary outcomes : reducing unhealthy eating-score ( MD : -0.14 , 95 % CI -0.02 to 0.27 ) and increased perception that people in the neighbourhood pulled together ( RR : 1.92 , 95 % CI 1.12 to 3.29 ) .", "The trial findings do not provide evidence supporting the conclusion of non-experimental components of the evaluation that intervention improved health behaviours , well-being and social outcomes .", "Low participation rates and population churn likely compromised any impact of the intervention .", "Imprecise estimation of outcomes and sampling bias may also have influenced findings .", "There is a need for greater investment in refining such programmes before implementation ; new methods to understand , longitudinally different pathways residents take through such interventions and their outcomes , and new theories of change that apply to each pathway ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Two phase I studies in healthy Chinese ( NCT01458743 ) and Western ( NCT01612507 ) subjects evaluated the pharmacokinetics ( PK ) and safety of single and multiple ceftaroline fosamil 600 mg infusions administered every 8 or 12 hours ( q8h or q12h ) .", "Each study enrolled subjects sequentially into 1 of 2 cohorts ( cohort 1 : 60-minute infusions ; cohort 2 : 120-minute infusions ) .", "All subjects in the Chinese ( n = 26 ) study received open label ceftaroline fosamil ; in the Western study , subjects ( n = 41 ) in each cohort were randomized 3 : 1 to ceftaroline fosamil or placebo infusions .", "Single infusions were administered on days 1 and 8 .", "On days 2 - 7 ( 3 - 7 for Chinese study , cohort 1 ) subjects received q12h or q8h infusions .", "Plasma and urine were collected on days 1 and 8 for PK analysis .", "Ceftaroline PK was linear and time-independent following single and multiple doses of ceftaroline fosamil .", "The magnitude and timing of peak plasma concentrations of ceftaroline ( active metabolite ) , ceftaroline fosamil ( prodrug ) , and ceftaroline M-1 ( inactive metabolite ) varied according to the ceftaroline fosamil dosing schedule ( q12h or q8h ) and infusion duration ( 60 minutes or 120 minutes ) , but overall plasma ceftaroline exposures within the respective dosing intervals were broadly similar across cohorts .", "The most frequent adverse events were rash/drug eruption , most of which were of mild-moderate intensity and considered related to treatment .", "Ceftaroline PK was broadly similar in healthy Chinese and Western subjects receiving equivalent dose regimens .", "The tolerability profile of ceftaroline fosamil in Chinese and Western subjects was consistent with previous clinical trials ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Pharmacologic treatment options for posttraumatic stress disorder ( PTSD ) are limited in number and effectiveness .", "Medications currently in use to treat PTSD were originally approved based on their efficacy in other disorders , such as major depression .", "Substantial research in PTSD suggests that increased activity of corticotropin releasing hormone ( CRH ) - containing circuits are involved in the pathophysiology of the disease .", "This Phase II trial aims to evaluate the efficacy of a CRH type 1 receptor ( CRHR1 ) antagonist in the treatment of PTSD .", "Currently untreated adult women , ages 18 to 65years , with a primary psychiatric diagnosis of PTSD of at least 3months ' duration , are being enrolled in a parallel-group , double-blind , placebo-controlled , randomized clinical trial evaluating the efficacy and safety of GSK561679 , a novel CRHR1 receptor antagonist .", "GSK561679 ( or matching placebo ) is prescribed at a fixed dose of 350mg nightly for six weeks .", "The primary trial hypothesis is that GSK561679 will reduce symptoms of PTSD , as measured by the Clinician-Administered PTSD Scale ( CAPS ) , significantly more than placebo after six weeks of treatment .", "Putative biological markers of PTSD which may influence treatment response are measured prior to randomization and after five weeks ' exposure to the study medication , including : fear conditioning and extinction using psychophysiological measures ; variants of stress-related genes and gene expression profiles ; and indices of HPA axis reactivity .", "In addition , the impact of PTSD and treatment on neuropsychological performance and functional capacity are assessed at baseline and after the fifth week of study medication .", "After completion of the six-week double blind treatment period , subjects enter a one-month follow-up period to monitor for sustained response and resolution of any adverse effects .", "Considerable preclinical and human research supports the hypothesis that alterations in central nervous system CRH neuronal activity are a potential mediator of PTSD symptoms .", "This study is the first to assess the efficacy of a specific antagonist of a CRH receptor in the treatment of PTSD .", "Furthermore , the biological and neuropsychological measures included in this trial will substantially inform our understanding of the mechanisms of PTSD .", "Clinicaltrials.gov Identifier : NCT01018992.Registered 6 November 2009 .", "First patient randomized 14 January 2010 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "This study evaluates the impact of the duration of pre-existing peripheral neuropathic pain on the therapeutic response to the capsaicin 8 % cutaneous patch .", "The non-interventional QUEPP ( QUTENZA - safety and effectiveness in peripheral neuropathic pain ) study evaluated the effectiveness of Qutenza ( TM ) in 1044 non-diabetic patients with peripheral neuropathic pain , who received a single application .", "Follow-up visits were scheduled at weeks 1-2 , 4 , 8 and 12 .", "A pre-defined co-analysis of changes in average pain intensity was performed based on the duration of pre-existing pain .", "In patients with pre-existing pain for < 6 months , the mean relative change of the numeric pain rating scale score on days 7-14 to week 12 versus baseline was -36.6 % [ 4.6 standard error of the mean ( SEM ) ; n = 105 ] , -25.1 % ( 1.9 SEM ; n = 311 ) in patients with pain duration of 6 months to 2 years , -22.3 % ( 1.6 SEM ; n = 391 ) in patients with pain for > 2-10 years , and -19.2 % ( 2.6 SEM ; n = 99 ) in patients with pain for > 10 years .", "Thirty percent and 50 % responder rates were 61.7 % and 39.3 % in patients with pre-existing pain for < 6 months , 42.3 % and 23.3 % in patients with pain for 6 months to 2 years , 40.9 % and 21.6 % in patients with pain for > 2-10 years , and 32.3 % and 14.1 % in patients with pain for > 10 years .", "The highest treatment response to the capsaicin 8 % cutaneous patch was observed in patients with a history of pre-existing peripheral neuropathic pain of less than 6 months , suggesting that early initiation of topical treatment might be indicated ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Longitudinal evidence linking diabetic retinopathy with changes in brain structure and cognition is sparse .", "We used data from the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) trial to determine whether diabetic retinopathy at baseline predicted changes in brain structure or cognition 40 months later .", "Participants from the ACCORD-MIND and ACCORD-Eye substudies were included in analyses of cognition ( n = 1,862 ) and MRI-derived brain variables ( n = 432 ) .", "Retinopathy was categorized as none , mild nonproliferative , or moderate/severe .", "Tests of cognition included the Mini-Mental State Examination ( MMSE ) , Digit Symbol Substitution Test ( DSST ) , Rey Auditory Verbal Learning Test , and Stroop test .", "Primary brain outcomes were gray matter and abnormal white matter volumes .", "Baseline retinopathy was associated with lower gray matter volume ( adjusted means of 470 , 466 , and 461 cm ( 3 ) for none , mild , and moderate/severe retinopathy , respectively ; P = 0.03 ) .", "Baseline retinopathy also predicted a greater change in MMSE and DSST scores at 40 months in each retinopathy category ( MMSE : -0.20 , -0.57 , and -0.42 , respectively [ P = 0.04 ] ; DSST : -1.30 , -1.84 , and -2.89 , respectively [ P = 0.01 ] ) .", "Diabetic retinopathy is associated with future cognitive decline in people with type 2 diabetes .", "Although diabetic retinopathy is not a perfect proxy for diabetes-related brain and cognitive decline , patients with type 2 diabetes and retinopathy represent a subgroup at higher risk for future cognitive decline ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The superiority of conventional polyethylene glycol ( PEG ) solution over sodium picosulfate with magnesium citrate ( SPMC ) for bowel preparation remains controversial .", "Therefore , this study compared the efficacy , safety , and tolerability of different regimens of SPMC and PEG solution in Koreans , who consume a traditional high-fiber diet .", "A total of 200 outpatients undergoing elective colonoscopy were randomized into four groups receiving different bowel-preparation regimens in a prospective study : 4 L PEG in the morning on the day of colonoscopy , two 2 L split doses of PEG , split doses of 2 SPMC sachets , and split doses of 3 SPMC sachets .", "Bowel cleansing efficacy was assessed based on the Ottawa bowel preparation scale and the Aronchick scale by endoscopists blinded to treatment , and patients filled out a questionnaire to determine satisfaction .", "There was no difference among groups with respect to bowel cleansing grade ( Ottawa scale , p = 0.314 ) .", "Patients in the SPMC groups were less likely to have abdominal fullness , pain , nausea , or vomiting than patients in the PEG groups ( p < 0.05 ) .", "Patients reported SPMC was more palatable than PEG .", "There were no significant differences among groups with respect to polyp detection rate .", "SPMC is as effective as conventional high-volume PEG-electrolyte solution in Korean patients .", "SPMC groups reported superior palatability and tolerability compared to PEG groups ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Information and behaviour can spread through interpersonal ties .", "By targeting influential individuals , health interventions that harness the distributive properties of social networks could be made more effective and efficient than those that do not .", "Our aim was to assess which targeting methods produce the greatest cascades or spillover effects and hence maximise population-level behaviour change .", "In this cluster randomised trial , participants were recruited from villages of the Department of Lempira , Honduras .", "We blocked villages on the basis of network size , socioeconomic status , and baseline rates of water purification , for delivery of two public health interventions : chlorine for water purification and multivitamins for micronutrient deficiencies .", "We then randomised villages , separately for each intervention , to one of three targeting methods , introducing the interventions to 5 % samples composed of either : randomly selected villagers ( n = 9 villages for each intervention ) ; villagers with the most social ties ( n = 9 ) ; or nominated friends of random villagers ( n = 9 ; the last strategy exploiting the so-called friendship paradox of social networks ) .", "Participants and data collectors were not aware of the targeting methods .", "Primary endpoints were the proportions of available products redeemed by the entire population under each targeting method .", "This trial is registered with ClinicalTrials.gov , number NCT01672580 .", "Between Aug 4 , and Aug 14 , 2012 , 32 villages in rural Honduras ( 25-541 participants each ; total study population of 5773 ) received public health interventions .", "For each intervention , nine villages ( each with 1-20 initial target individuals ) were randomised , using a blocked design , to each of the three targeting methods .", "In nomination-targeted villages , 951 ( 743 % ) of 1280 available multivitamin tickets were redeemed compared with 940 ( 662 % ) of 1420 in randomly targeted villages and 744 ( 610 % ) of 1220 in indegree-targeted villages .", "All pairwise differences in redemption rates were significant ( p < 001 ) after correction for multiple comparisons .", "Targeting nominated friends increased adoption of the nutritional intervention by 122 % compared with random targeting ( 95 % CI 69-179 ) .", "Targeting the most highly connected individuals , by contrast , produced no greater adoption of either intervention , compared with random targeting .", "Introduction of a health intervention to the nominated friends of random individuals can enhance that intervention 's diffusion by exploiting intrinsic properties of human social networks .", "This method has the additional advantage of scalability because it can be implemented without mapping the network .", "Deployment of certain types of health interventions via network targeting , without increasing the number of individuals targeted or the resources used , could enhance the adoption and efficiency of those interventions , thereby improving population health .", "National Institutes of Health , The Bill & Melinda Gates Foundation , Star Family Foundation , and the Canadian Institutes of Health Research ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Malnourished HIV-infected African adults are at high risk of early mortality after starting antiretroviral therapy ( ART ) .", "We hypothesized that short-course , high-dose vitamin and mineral supplementation in lipid nutritional supplements would decrease mortality .", "The study was an individually-randomised phase III trial conducted in ART clinics in Mwanza , Tanzania , and Lusaka , Zambia .", "Participants were 1,815 ART-nave non-pregnant adults with body mass index ( BMI ) < 18.5 kg/m who were referred for ART based on CD4 count < 350 cells/L or WHO stage 3 or 4 disease .", "The intervention was a lipid-based nutritional supplement either without ( LNS ) or with additional vitamins and minerals ( LNS-VM ) , beginning prior to ART initiation ; supplement amounts were 30 g/day ( 150 kcal ) from recruitment until 2 weeks after starting ART and 250 g/day ( 1,400 kcal ) from weeks 2 to 6 after starting ART .", "The primary outcome was mortality between recruitment and 12 weeks of ART .", "Secondary outcomes were serious adverse events ( SAEs ) and abnormal electrolytes throughout , and BMI and CD4 count at 12 weeks ART .", "Follow-up for the primary outcome was 91 % .", "Median adherence was 66 % .", "There were 181 deaths in the LNS group ( 83.7 / 100 person-years ) and 184 ( 82.6 / 100 person-years ) in the LNS-VM group ( rate ratio ( RR ) , 0.99 ; 95 % CI , 0.80-1 .21 ; P = 0.89 ) .", "The intervention did not affect SAEs or BMI , but decreased the incidence of low serum phosphate ( RR , 0.73 ; 95 % CI , 0.55-0 .97 ; P = 0.03 ) and increased the incidence of high serum potassium ( RR , 1.60 ; 95 % CI , 1.19-2 .15 ; P = 0.002 ) and phosphate ( RR , 1.23 ; 95 % CI , 1.10-1 .37 ; P < 0.001 ) .", "Mean CD4 count at 12 weeks post-ART was 25 cells/L ( 95 % CI , 4-46 ) higher in the LNS-VM compared to the LNS arm ( P = 0.02 ) .", "High-dose vitamin and mineral supplementation in LNS , compared to LNS alone , did not decrease mortality or clinical SAEs in malnourished African adults initiating ART , but improved CD4 count .", "The higher frequency of elevated serum potassium and phosphate levels suggests high-level electrolyte supplementation for all patients is inadvisable but the addition of micronutrient supplements to ART may provide clinical benefits in these patients .", "PACTR201106000300631 , registered on 1st June 2011 ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Eicosapentaenoic acid ( EPA ) , abundant in oily fish , is reported to reduce skin inflammation and provide photoprotection , potential mechanisms include competition with arachidonic acid ( AA ) for metabolism by cyclooxygenases/lipoxygenases to less pro-inflammatory mediators .", "We thus examine impact of EPA intake on levels of AA , EPA and their resulting eicosanoids in human skin with or without ultraviolet radiation ( UVR ) challenge .", "In a double-blind randomised controlled study , 79 females took 5 g EPA-rich or control lipid for 12 wk .", "Pre - and post-supplementation , red blood cell and skin polyunsaturated fatty acids were assessed by GC , and eicosanoids from unexposed and UVR-exposed skin by LC-MS/MS .", "Active supplementation increased red blood cell and dermal EPA versus control ( both p < 0.001 ) , lowering relative AA : EPA content ( 4:1 versus 15:1 and 5:1 versus 11:1 , respectively ; both p < 0.001 ) .", "Pre-supplementation , UVR increased PGE2 , 12-hydroxyeicosatetraenoic acids , 12-HEPE ( all p < 0.001 ) and PGE3 ( p < 0.05 ) .", "Post-EPA , PGE2 was reduced in unchallenged skin ( p < 0.05 ) while EPA-derived PGE3 ( non-sign ) and 12-HEPE ( p < 0.01 ) were elevated post-UVR .", "Thus , post-EPA , PGE2 : PGE3 was lower in unchallenged ( 12:1 versus 28:1 ; p < 0.05 ) and UVR exposed ( 12:1 versus 54:1 ; p < 0.01 ) skin ; 12-hydroxyeicosatetraenoic acids :12 - HEPE was lower in UVR-exposed skin ( 3:1 versus 11:1 ; p < 0.001 ) .", "Dietary EPA augments skin EPA : AA content , shifting eicosanoid synthesis towards less pro-inflammatory species , and promoting a regulatory milieu under basal conditions and in response to inflammatory insult ." ]

[ "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "We compared the efficacies of cold knife excision and carbon dioxide ( CO2 ) laser fiber excision of oral cavity leukoplakia .", "Between August 2009 and June 2011,45 patients who underwent excision of oral cavity leukoplakia were assessed for operative time , use of bipolar cautery , blood loss , and number of intraoperative margins needed .", "Patients were assigned randomly to either a cold knife group ( 23 procedures ) or a CO2 laser fiber group ( 24 procedures ) at the time of the procedure .", "The times of excision were similar in the CO2 laser fiber group ( 1.64 min/cm2 ) and the cold knife group ( 1.70 min/cm2 ) .", "There were large differences between the CO2 laser fiber group and the cold knife group in the categories of bipolar cautery uses per square centimeter ( 0.34 uses versus 3.32 uses ) and blood loss ( 0.19 g/cm2 versus 2.55 g/cm2 ) .", "The average number of margins needed to clear a specimen by frozen section was 1.21 for the CO2 laser fiber group and 1.83 for the cold knife group .", "The CO2 laser fiber did not show an advantage in operative time .", "The CO2 laser fiber did show better outcomes in the areas of blood loss , bipolar cautery use , and intraoperative margins needed ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Research has shown that auditory training improves auditory sensory skills ; however , it is unclear whether this improvement is transferred to top-down skills , such as memory , attention , and language , and whether it depends on group characteristics in regard to memory and attention skills .", "The primary goal of this research was to investigate the generalization of learning from auditory sensory skills to top-down skills such as memory , attention , and language .", "We also aimed to compare whether this generalization process occurs in the same way among typically developing children and children with speech sound disorder .", "This study was a randomized controlled trial .", "Typically developing 7 - to 12-yr-old children and children with speech sound disorder were separated into four groups : a trained control group ( TDT ; n = 10 , age 9.6 2.0 yr ) , a nontrained control group ( TDNT ; n = 11 , age 8.2 1.6 yr ) , a trained study group ( SSDT ; n = 10 , age 7.7 1.2 yr ) , and a nontrained study group ( SSDNT ; n = 8 , age 8.6 1.2 yr ) .", "Both trained groups underwent a computerized , nonverbal auditory training that focused on frequency discrimination , ordering , and backward-masking tasks .", "The training consisted of twelve 45 min sessions , once a week , for a total of 9 hr of training , approximately .", "Near-transfer ( Gap-In-Noise [ GIN ] and Frequency Pattern Test ) and far-transfer measures ( auditory and visual sustained attention tests , phonological working memory and language tests ) were applied before and after training .", "The results were analyzed using a 2 2 2 mixed-model analysis of variance with the group and training as the between-group variables and the period as the within-group variable .", "The significance threshold was p 0.05 .", "There was a group period training interaction for GIN [ F ( 1.35 ) = 7.18 , p = 0.011 ] , indicating a significant threshold reduction only for the TDT group ( Tukey multiple comparisons ) .", "There was a significant group period interaction [ F ( 1.35 ) = 5.52 , p = 0.025 ] and a training period interaction for visual reaction time [ F ( 1.35 ) = 4.20 , p = 0.048 ] , indicating improvement in the SSDT group and worsening in both nontrained groups .", "There was also a significant group training period interaction [ F ( 1.35 ) = 4.27 , p = 0.046 ] for the auditory false alarms , with a significant improvement after training only for the SSDT group .", "Analysis of variance also revealed that all groups exhibited approximately the same level of gains for all measures , except for GIN [ F ( 3,38 ) = 4.261 , p = 0.011 ] and visual response time [ F ( 3.38 ) = 4.069 , p = 0.014 ] .", "After training , the TDT group demonstrated a significant improvement for GIN and the SSDT exhibited the same for sustained attention , indicating learning generalization from an auditory sensory training to a top-down skill .", "For the other measures , all groups exhibited approximately the same level of gains , indicating the presence of a test-retest effect .", "Our findings also show that the memory span was not related to the learning generalization process given that the SSDT exhibited a more pronounced gain in attention skills after the sensory training ." ]

[ "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Although meditation therapies such as the Transcendental Meditation ( TM ) technique are commonly used to assist with stress and stress-related diseases , there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness .", "This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder ( PTSD ) in a Veteran population .", "This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure ( PE ) - and an active control condition ( health education [ HE ] ) for PTSD .", "This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD , with testing conducted at 0 and 3 months for PTSD symptoms , depression , mood disturbance , quality of life , behavioral factors , and physiological/biochemical and gene expression mechanisms using validated measures .", "The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms , using the Clinician Administered PTSD Scale ( CAPS ) .", "The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD .", "The projected results will help to establish the overall efficacy of TM for PTSD among Veterans , identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms , and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Autism spectrum disorder ( ASD ) is a neurodevelopmental disorder characterized by social communication impairments and restricted , repetitive behaviors .", "Whereas current pharmacological interventions for ASD focus primarily on psychiatric symptoms , including agitation and obsessive behaviors , few agents target core symptomatology .", "It has been previously hypothesized that abnormalities in facial scanning , such as reduced eye contact or increased mouth fixation , contribute to social communication deficits in ASD .", "In addition , previous reports have suggested elevated stress and anxiety in ASD , symptoms that are believed to impact facial scanning patterns .", "The present pilot study sought to explore the effects of pharmacological intervention via propranolol , a nonselective - adrenergic antagonist and known anxiolytic , on facial scanning in ASD .", "Specifically , we wished to determine whether there is an increase in eye contact and a decrease in mouth fixation with administration of propranolol .", "A sample of 14 participants with ASD and 14 matched controls participated in two study sessions in which propranolol and placebo were administered in a counterbalanced , double-blinded manner .", "At each session , ocular fixation data were collected during presentation of video stimuli of 16 human faces .", "Fixation time on the eye , nose , and mouth regions of the face stimuli was analyzed .", "The baseline fixation patterns for the ASD and control groups did not significantly differ ; however , administration of propranolol was associated with a significant reduction in mouth fixation for the ASD group .", "Additionally , mouth fixation was positively related to nonverbal communication impairment in the ASD group .", "Although eye fixation in ASD appears typical in the present study , the effect of propranolol in reducing mouth fixation suggests an important focus for further research .", "Future studies are needed to better characterize the relationship between stress and anxiety and facial scanning in ASD , as well as the effects of pharmacological intervention ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Does the initiation of corifollitropin alfa administration on cycle day 4 instead of cycle day 2 result in a reduced total rFSH consumption in a GnRH antagonist protocol ?", "Initiation of corifollitropin alfa on cycle day 4 compared with day 2 results in significantly reduced total rFSH consumption at the end of the follicular phase .", "In vitro fertilization treatment is associated with significant physical , psychological and emotional stress in infertile patients .", "This notion has fuelled the search for simplified treatment approaches that may reduce the treatment burden .", "The introduction of corifollitropin alfa has provided a more patient-friendly treatment protocol because it obviates the need for daily hormonal injections .", "In addition , postponing the initiation of hormonal stimulation should also reduce the total gonadotrophin consumption and the number of injections needed .", "A prospective randomized controlled pilot study was conducted in a university centre in Belgium .", "Between December 2011 and March 2013 , 59 patients were randomized in the study and 52 of these patients received the allocated intervention .", "All patients were randomly assigned to the control group ( CD2 ) , with initiation of corifollitropin alfa on cycle day 2 , or to the study group ( CD4 ) with initiation of stimulation on day 4 .", "The GnRH antagonist was administered from cycle day 7 onwards in both treatment arms .", "The main outcome measure was the total rFSH consumption at the end of the follicular phase after corifollitropin alfa treatment .", "The total dose of rFSH at the end of the follicular phase was significantly reduced in the CD4 group compared with the CD2 group ( 324 ( 276 ) IU in the CD2 group versus 173 ( 255 ) IU in the CD4 group , P = 0.015 , mean difference -151 , 95 % confidence interval ( CI ) -301 to -1 ) .", "A significant reduction of total duration of rFSH stimulation in the CD4 group was also observed ( 8.6 ( 1.4 ) days in CD2 group versus 7.8 ( 1.2 ) days in the CD4 group , P = 0.008 , mean difference -0.8 , 95 % CI -1.6 to -0.1 ) .", "The number of cumulus-oocyte-complexes was comparable in both treatment groups ( 12.8 ( 7.3 ) in CD2 group versus 14.7 ( 8.8 ) in the CD4 group , P = 0.461 , mean difference 1.8 , 95 % CI -2.7 to 6.4 ) .", "Ongoing pregnancy rates of 48 % in the CD2 group and 41 % in the CD4 group were achieved ( P = 0.60 , relative risk ( RR ) 0.85 , 95 % CI 0.46-1 .56 ) .", "Final oocyte maturation was triggered with GnRH agonist instead of hCG in two patients in the CD2 group and in eight patients in the CD4 group , because of an increased risk of ovarian hyperstimulation syndrome ( P = 0.078 , RR 3.7 ( 95 % CI 0.88-15 .8 ) .", "Before general implementation can be advised , this trial should be validated in a much larger randomized trial .", "WIDER IMPLICATIONS OF THE FINDINGS If the approach of starting ovarian stimulation on Day 4 of the cycle could be implemented in a large population of infertile patients , it would result in a significant reduction of gonadotrophin consumption .", "No external finance was involved in this study .", "C.B and N.P.P. have received fees from MSD .", "Otherwise the authors declare no conflict of interest regarding this study .", "The trial was registered at clinicaltrials.gov ( NCT01633580 ) ." ]

[ "OBJECTIVE", "CONCLUSIONS", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND" ]

[ "The pandemic potential of avian influenza A/H5N1 should not be overlooked , and the continued development of vaccines against these highly pathogenic viruses is a public health priority .", "This open-label extension booster study followed a Phase III study of 1206 adults who had received two 3.75 g doses of primary AS03A-adjuvanted or non-adjuvanted H5N1 split-virus vaccine ( A/Vietnam/1194 / 2004 ; clade 1 ) ( NCT00449670 ) .", "The aim of the extension study was to evaluate different timings for heterologous AS03A-adjuvanted booster vaccination ( A/Indonesia/5 / 2005 ; clade 2.1 ) given at Month 6 , 12 , or 36 post-primary vaccination .", "Immunogenicity was assessed 21days after each booster vaccination and the persistence of immune responses against the primary vaccine strain ( A/Vietnam ) and the booster strain ( A/Indonesia ) was evaluated up to Month 48 post-primary vaccination .", "Reactogenicity and safety were also assessed .", "After booster vaccination given at Month 6 , HI antibody responses to primary vaccine , and booster vaccine strains were markedly higher with one dose of AS03A-H5N1 booster vaccine in the AS03A-adjuvanted primary vaccine group compared with two doses of booster vaccine in the non-adjuvanted primary vaccine group .", "HI antibody responses were robust against the primary and booster vaccine strains 21days after boosting at Month 12 or 36 .", "At Month 48 , in subjects boosted at Month 6 , 12 , or 36 , HI antibody titers of 1:40 against the booster strain persisted in 39.2 % , 61.2 % , and 95.6 % of subjects , respectively .", "Neutralizing antibody responses and cell-mediated immune responses also showed that AS03A-H5N1 heterologous booster vaccination elicited robust immune responses within 21days of boosting at Month 6 , 12 , or 36 post-primary vaccination .", "The booster vaccine was well tolerated , and no safety concerns were raised .", "In Asian adults primed with two doses of AS03A-adjuvanted H5N1 pandemic influenza vaccine , strong cross-clade anamnestic antibody responses were observed after one dose of AS03A-H5N1 heterologous booster vaccine given at Month 6 , 12 , or 36 after priming , suggesting that AS03A-adjuvanted H5N1 vaccines may provide highly flexible prime-boost schedules .", "Although immunogenicity decreased with time , vaccinated populations could potentially be protected for up to three years after vaccination , which is likely to far exceed the peak of the a pandemic ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Labor is one of the most painful experiences a woman may face during her lifetime .", "One of the most effective methods used for eliminating this pain is epidural analgesia .", "The aim of this study to determine the impact of adding morphine to low-dose bupivacaine epidural anesthesia on labor and neonatal outcomes , and maternal side effects .", "This is a prospective randomized double-blind study comparing two regimens of anesthetic agents used for epidural anesthesia in labor .", "A total of 120 pregnant women were randomized into two groups with 60 subjects in each study arm .", "A catheter was inserted , and 0.1 % bupivacaine + 2 g/mL fentanyl in 15 mL saline were given to Group bupivacaine-fentanyl ( Group BF ) , while 0.0625 % bupivacaine + 2 g/ml fentanyl + 2 mg morphine in 15 mL saline were given to Group bupivacaine-fentanyl-morphine ( Group BFM ) with no test dosing from the needle .", "No morphine was added to the subsequent epidural injections in Group BFM .", "The total dose of bupivacaine was significantly lower in Group BFM relative to Group BF ( P = 0.0001 ) .", "The visual analogu scalescores at 15 , 30 , and 45 min were significantly lower in Group BF compared to thosein Group BFM ( P = 0.0001 , P = 0.001 , and P = 0.006 , respectively ) .", "The second stage of labor was significantly shorter in Group BFM relative to Group BF ( P = 0.027 and P = 0.003 , respectively ) .", "The satisfaction with analgesia following the first dose was higher in the nonmorphine group ( P = 0.0001 ) .", "However , maternal postpartum satisfaction was similar in both groups .", "Either nausea or vomiting was recorded in eight patients in Group BFM .", "We believe that epidural analgesia comprised of a low-dose local anaesthetic and 2 mg morphine provides a painless labor that significantly reducesthe use of local anesthetic without changing the efficiency of the analgesic , ensuring the mother 's satisfaction without leading to an adverse effect on the mother or foetus , while mildly ( but significantly ) shortening the second stage of labor ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "This phase III study assessed the safety and immunogenicity of MenACWY-CRM , a quadrivalent meningococcal conjugate vaccine , administered with routine vaccines starting at 2 months of age .", "Healthy infants received MenACWY-CRM in a two - or three-dose primary infant series plus a single toddler dose .", "In addition , a two-dose toddler catch-up series was evaluated .", "Immune responses to MenACWY-CRM were assessed for serum bactericidal activity with human complement ( hSBA ) .", "Reactogenicity and safety results were collected systematically .", "After a full infant/toddler series or two-dose toddler catch-up series , MenACWY-CRM elicited immune responses against the four serogroups in 94-100 % of subjects .", "Noninferiority of the two - versus three-dose MenACWY-CRM infant dosing regimen was established for geometric mean titers for all serogroups .", "Following the three-dose infant primary series , 89-98 % of subjects achieved an hSBA 8 across all serogroups .", "Immune responses to concomitant routine vaccines given with MenACWY-CRM were noninferior to responses to routine vaccines alone , except for pertactin after the two-dose infant series .", "Noninferiority criteria were met for all concomitant antigens after the three-dose infant series .", "MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated .", "No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Teacher training may improve teaching effectiveness , but it might also have paradoxical effects .", "Research on expertise development suggests that the integration of new strategies may result in a temporary deterioration of performance until higher levels of competence are reached .", "In this study , the impact of a clinical teacher training on teaching effectiveness was assessed in an intensive course in emergency medicine .", "As primary study outcome students ' practical skills at the end of their course were chosen .", "The authors matched 18 clinical teachers according to clinical experience and teaching experience and then randomly assigned them to a two-day-teacher training , or no training .", "After 14 days , both groups taught within a 12-hour intensive course in emergency medicine for undergraduate students .", "The course followed a clearly defined curriculum .", "After the course students were assessed by structured clinical examination ( SCE ) and MCQ .", "The teaching quality was rated by students using a questionnaire .", "Data for 96 students with trained teachers , and 97 students with untrained teachers were included .", "Students taught by untrained teachers performed better in the SCE domains ` alarm call ' ( p < 0.01 ) and ` ventilation ' ( p = 0.01 ) , while the domains ` chest compressions ' and ` use of automated defibrillator ' did not differ .", "MCQ scores revealed no statistical difference .", "Overall , teaching quality was rated significantly better by students of untrained teachers ( p = 0.05 ) .", "At the end of a structured intensive course in emergency medicine , students of trained clinical teachers performed worse in 2 of 4 practical SCE domains compared to students of untrained teachers .", "In addition , subjective evaluations of teaching quality were worse in the group of trained teachers .", "Difficulties in integrating new strategies in their teaching styles might be a possible explanation ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Nivolumab , a programmed death 1 ( PD-1 ) checkpoint inhibitor , was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma .", "This randomized , open-label , phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment .", "A total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned ( in a 1:1 ratio ) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily .", "The primary end point was overall survival .", "The secondary end points included the objective response rate and safety .", "The median overall survival was 25.0 months ( 95 % confidence interval [ CI ] , 21.8 to not estimable ) with nivolumab and 19.6 months ( 95 % CI , 17.6 to 23.1 ) with everolimus .", "The hazard ratio for death with nivolumab versus everolimus was 0.73 ( 98.5 % CI , 0.57 to 0.93 ; P = 0.002 ) , which met the prespecified criterion for superiority ( P0 .0148 ) .", "The objective response rate was greater with nivolumab than with everolimus ( 25 % vs. 5 % ; odds ratio , 5.98 [ 95 % CI , 3.68 to 9.72 ] ; P < 0.001 ) .", "The median progression-free survival was 4.6 months ( 95 % CI , 3.7 to 5.4 ) with nivolumab and 4.4 months ( 95 % CI , 3.7 to 5.5 ) with everolimus ( hazard ratio , 0.88 ; 95 % CI , 0.75 to 1.03 ; P = 0.11 ) .", "Grade 3 or 4 treatment-related adverse events occurred in 19 % of the patients receiving nivolumab and in 37 % of the patients receiving everolimus ; the most common event with nivolumab was fatigue ( in 2 % of the patients ) , and the most common event with everolimus was anemia ( in 8 % ) .", "Among patients with previously treated advanced renal-cell carcinoma , overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus .", "( Funded by Bristol-Myers Squibb ; CheckMate 025 ClinicalTrials.gov number , NCT01668784 . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To study changes of plasma ADMA levels of patients with non-ST elevation myocardial infarction ( NSTEMI ) undergoing percutaneous coronary intervention ( PCI ) and to explore the effect of Salvia Miltiorrhiza ( SM ) on them .", "Totally 52 patients with confirmed NSTEMI undergoing PCI were randomly assigned to the SM treated group and the control group , 26 in each group .", "Patients in the SM treated group received the conventional therapy plus SM ( 1 g each time , three times per day till one month after PCI ) .", "Those in the control group only received the conventional therapy .", "Plasma ADMA levels were measured before PCI , and at day 1 and 30 after PCI .", "Plasma ADMA levels in both group obviously decreased at day 30 after PCI with statistical difference ( P < 0.01 ) .", "The decrement was more obviously seen in the SM treated group , with statistical difference when compared with the control group ( P < 0.01 ) .", "Patients with NSTEMI undergoing PCI could have plasma ADMA levels decreased .", "Administration of SM just before PCI might be associated with negative regulating plasma ADMA levels ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To assess treatment outcomes via acoustic voice laboratory measurements before and after intervention in patients with common voice problems and Determine if outcome sensitivity of certain voice laboratory measures varies with disorder type .", "Retrospective and single-blinded .", "In this study , 40 patients with a single voice disorder diagnosis of either benign vocal fold lesions ( lesions ) , primary muscle tension dysphonia ( MTD-1 ) , vocal fold atrophy ( atrophy ) or unilateral vocal fold paralysis ( UVFP ) underwent baseline testing , a single intervention-type ( phonosurgery/voice therapy ) , and follow-up testing at uniform time points .", "Ten patients per diagnosis group were analyzed before and after treatment .", "Time - and frequency-based acoustic measures taken from vowels and sentences as well as patient-perceptual analysis ( Voice Handicap Index-10 ) were reviewed .", "Statistically significant improvements were observed for three of four groups .", "Patients with muscle tension dysphonia displayed an improvement in Cepstral Spectral Index of Dysphonia speech ( CSID ) ( P < 0.05 ) .", "Patients with lesions had improved Voice Handicap Index-10 ( P < 0.05 ) , cepstral peak prominence ( CPP ) vowel standard deviation ( P < 0.05 ) , and CPP speech ( P < 0.05 ) .", "Patients with atrophy did not demonstrate significant improvement in any measure .", "Patients with unilateral vocal fold paralysis showed an improvement in CSID speech ( P < 0.05 ) and CPP speech ( P < 0.05 ) .", "In addition , strong effect sizes were observed for many of the acoustic parameters studied .", "For all groups except atrophy , treatment was successful in improving patient perception of voice handicap and/or some acoustic voice parameters .", "A disorder-specific response to frequency-based acoustic measures was found ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Breakthrough cancer pain ( BTcP ) is recognized as a clinically significant complication of chronic cancer pain with most BTcP episodes peaking in intensity within a few minutes and lasting for approximately 30min .", "Although a number of rapid-onset fentanyl preparations have been developed in the last decade , BTcP is still typically managed through the use of rescue doses of oral morphine but a comparative study of sublingual fentanyl and oral morphine is still lacking .", "The aim of this study was to determine the efficacy , tolerability , and patient satisfaction of sublingual fentanyl citrate ( SLF ) and oral morphine solution ( OM ) in the treatment of BTcP .", "In this prospective , longitudinal , controlled-study , 40 patients with BTcP were allocated to receive oral morphine ( OM ) or sublingual fentanyl ( SLF ) .", "Pain intensity level on a 0-10 numerical rating visual analog scale ( VAS ) , frequency of BTcP throughout the day , onset of relief ( 0-5 , 6-10 , 11-15 , or over 16min ) , time required for dose titration , patient satisfaction and adverse effects were assessed at 3 , 7 , 15 , and 30days after starting the treatment .", "Mean doses of opioids for BTcP were 23523.4 g ( SLF ) and 385.2 mg ( OM ) .", "The mean pain intensity levels were significantly lower with SLF than OM at 3days ( 6.0 vs. 6.95 ; p = 0,001 ) , 7days ( 4.15 vs. 6.25 , p < 0.001 ) , 15days ( 3.45 vs. 5.35 , p < 0.001 ) , and 30days ( 3.05 vs. 4.45 , p < 0.001 ) .", "SLF provided significantly faster relief for BTcP than OM ( p < 0.001 ) with a shorter dose titration period ( mean 6.63.3 vs. 13.34.9 days ; p < 0.001 ) and better satisfaction scores and with a very good safety profile .", "Administration of SLF might provide a more effective treatment option than oral morphine for BTcP ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Four cycles of etoposide plus cisplatin and accelerated hyperfractionated thoracic radiotherapy ( AHTRT ) is the standard of care for limited-stage small-cell lung cancer ( SCLC ) .", "Irinotecan plus cisplatin significantly improved overall survival compared with etoposide plus cisplatin for extensive-stage SCLC .", "We compared these regimens for overall survival of patients with limited-stage SCLC .", "We did this phase 3 study in 36 institutions in Japan .", "Eligibility criteria included age 20-70 years , Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-1 , and adequate organ functions .", "Eligible patients with previously untreated limited-stage SCLC received one cycle of etoposide plus cisplatin ( intravenous etoposide 100 mg/m ( 2 ) on days 1-3 ; intravenous cisplatin 80 mg/m ( 2 ) on day 1 ) plus AHTRT ( 1.5 Gy twice daily , 5 days a week , total 45 Gy over 3 weeks ) .", "Patients without progressive disease following induction therapy were randomised ( 1:1 ratio , using a minimisation method with biased-coin assignment balancing on ECOG performance status [ 0 vs 1 ] , response to induction chemoradiotherapy [ complete response plus near complete response vs partial response and stable disease ] , and institution ) to receive either three further cycles of consolidation etoposide plus cisplatin or irinotecan plus cisplatin ( intravenous irinotecan 60 mg/m ( 2 ) on days 1 , 8 , 15 ; intravenous cisplatin 60 mg/m ( 2 ) on day 1 ) .", "Patients , physicians , and investigators were aware of allocation .", "The primary endpoint was overall survival after randomisation ; primary analysis was by intention to treat .", "This trial is registered with ClinicalTrials.gov , number NCT00144989 , and the UMIN Clinical Trials Registry , number C000000095 .", "281 patients were enrolled between Sept 1 , 2002 , and Oct 2 , 2006 .", "After induction etoposide plus cisplatin and AHTRT , 258 patients were randomised to consolidation etoposide plus cisplatin ( n = 129 ) or irinotecan plus cisplatin ( n = 129 ) .", "In the etoposide plus cisplatin group , median overall survival was 3.2 years ( 95 % CI 2.4-4 .1 ) .", "In the irinotecan and cisplatin group , median overall survival was 2.8 years ( 95 % CI 2.4-3 .6 ) ; overall survival did not differ between the two groups ( hazard ratio 1.09 [ 95 % CI 0.80-1 .46 ] , one-sided stratified log-rank p = 0.70 ) .", "The most common adverse events of grade 3 or 4 were neutropenia ( 120 [ 95 % ] in the etoposide plus cisplatin group vs 101 [ 78 % ] in the irinotecan plus cisplatin group ) , anaemia ( 44 [ 35 % ] vs 50 [ 39 % ] ) , thrombocytopenia ( 26 [ 21 % ] vs six [ 5 % ] ) , febrile neutropenia ( 21 [ 17 % ] vs 18 [ 14 % ] ) , and diarrhoea ( two [ 2 % ] vs 13 [ 10 % ] ) .", "There was one treatment-related adverse event leading to death in each group ( radiation pneumonitis in the etoposide plus cisplatin group ; brain infarction in the irinotecan plus cisplatin group ) .", "Four cycles of etoposide plus cisplatin and AHTRT should continue to be the standard of care for limited-stage SCLC .", "National Cancer Center and the Ministry of Health , Labour , and Welfare of Japan ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "To compare the response with synthetic human parathyroid hormone ( PTH ) 1-34 delivered by twice-daily injection vs insulin pump in children with severe congenital hypoparathyroidism due to calcium receptor mutation or autoimmune polyglandular syndrome type 1 .", "Children and young adults aged 7-20 years with congenital hypoparathyroidism ( N = 12 ) were randomized to receive PTH 1-34 , delivered either by twice-daily subcutaneous injection or insulin pump for 13 weeks , followed by crossover to the opposite delivery method .", "The principal outcome measures were serum and urine calcium levels .", "Secondary outcomes included serum and urine magnesium and phosphate levels and bone turnover markers .", "PTH 1-34 delivered via pump produced near normalization of mean serum calcium ( 2.02 0.05 [ pump ] vs 1.88 0.03 [ injection ] mmol/L , P < .05 , normal 2.05-2 .5 mmol/L ) , normalized mean urine calcium excretion ( 5.17 1.10 [ pump ] vs 6.67 0.76 mmol/24 h/1 .73 m ( 2 ) , P = .3 ) , and significantly reduced markers of bone turnover ( P < .02 ) .", "Serum and urine calcium and magnesium showed a biphasic pattern during twice-daily injection vs minimal fluctuation during pump delivery .", "The PTH 1-34 dosage was markedly reduced during pump delivery ( 0.32 0.04 vs 0.85 0.11 g/kg/d , P < .001 ) , and magnesium supplements were also reduced ( P < .001 ) .", "Compared with twice-daily delivery , pump delivery of PTH 1-34 provides more physiologic calcium homeostasis and bone turnover in children with severe congenital hypoparathyroidism ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Whole-body ischemia during out-of-hospital cardiac arrest triggers immediate activation of inflammatory systems leading to a sepsis-like syndrome .", "The aim was to investigate the association between level of systemic inflammation and mortality in survivors after out-of-hospital cardiac arrest treated with targeted temperature management .", "Post hoc analysis .", "Single-center study of a prospective multicenter randomized study .", "One hundred sixty-nine patients ( 99 % ) with available blood samples out of 171 patients included in the Target Temperature Management trial , randomly assigning patients to targeted temperature management at 33C or 36C .", "None .", "At baseline and 24 , 48 , and 72 hours after out-of-hospital cardiac arrest , blood samples were obtained and screened for a battery of inflammatory markers .", "Level of interleukin-1 , interleukin-2 , interleukin-4 , interleukin-5 , interleukin-6 , interleukin-9 , interleukin-10 , interleukin-12 , interleukin-13 , tumor necrosis factor - , interferon - , C-reactive protein , and procalcitonin were measured .", "Mortality at 30 days was evaluated by Cox analysis , and the predictive capability of inflammatory markers was evaluated by area under the curve .", "Level of all inflammatory markers changed significantly within 72 hours after out-of-hospital cardiac arrest ( all p values < 0.001 ) , but only procalcitonin levels showed overall differences between nonsurvivors and survivors ( p = 0.0002 ) .", "At baseline , interleukin-6 was independently associated with mortality , whereas both interleukin-6 levels ( hazard ratio = 1.23 [ 1.01-1 .49 ] ; p = 0.04 ) and procalcitonin levels ( hazard ratio = 1.20 [ 1.03-1 .39 ] ; p = 0.02 ) 24 hours after out-of-hospital cardiac arrest were associated with 30-day mortality with no interactions between targeted temperature management group and levels of interleukin-6 ( p = 0.25 ) or procalcitonin ( p = 0.85 ) .", "None of the other inflammatory markers were independently associated with mortality .", "Area under the curve for procalcitonin and interleukin-6 , 24 hours after out-of-hospital cardiac arrest , were 0.74 and 0.63 , respectively .", "Level of inflammation , assessed by interleukin-6 and procalcitonin , was independently associated with increased mortality with the highest discriminative value obtained 24 hours after out-of-hospital cardiac arrest .", "Interventions aiming at decreasing level of inflammation as a way to improve outcome may be investigated in future studies ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Candida spp .", "are frequently recovered from endotracheal secretions in critically ill patients suspected of having ventilator-associated pneumonia .", "Observational studies reported an association with worse clinical outcomes but the effect of antifungal therapy in these patients remains unclear .", "We designed this pilot study to assess the feasibility of a larger trial and to evaluate inflammatory profiles and clinical outcomes in these patients .", "We conducted a double-blind , placebo-controlled , multicenter pilot randomized trial of antifungal therapy in critically ill patients with a clinical suspicion of ventilator-associated pneumonia with positive airway secretion specimens for Candida spp .", "We also included an observational group without Candida spp .", "in their airway secretions .", "We measured recruitment rate , inflammatory and innate immune function profiles over time , and clinical outcomes .", "We recruited 60 patients into the randomized trial and 29 patients into the observational study .", "Markers of inflammation and all clinical outcomes were comparable between placebo and antifungal treatment group at baseline and over time .", "At baseline , plasma TNF - levels were higher in patients with VAP and Candida compared to the observational group ( mean SD ) ( 21.8 23.1 versus 12.4 9.3 pg/ml , p = 0.02 ) and these patients had lower innate immune function as evidenced by reduced whole blood ex vivo LPS-induced TNF - production capacity ( 854.8 855.2 versus 1,559.4 1,290.6 pg/ml , p = 0.01 ) .", "This study does not provide evidence to support a larger trial examining the efficacy of empiric antifungal treatment in patients with a clinical suspicion of ventilator-associated pneumonia and Candida in the endotracheal secretions .", "The presence of Candida in the lung may be associated with persistent inflammation and immunosuppression ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The purpose of the current study was to investigate whether an informative Web site is effective at producing higher scores for an individual 's knowledge of Alzheimer 's disease ( AD ) relative to those who do not visit a Web site .", "A total of 552 participants completed the study on Amazon 's Mechanical Turk ; half were randomly assigned to visit alz.org , while a control group did not .", "Both groups were given the AD Knowledge Scale ( ADKS ) to assess their knowledge of AD .", "Participants who visited alz.org scored significantly higher on the ADKS than those in the control group .", "Participants who were health care workers demonstrated higher scores than others in the experimental condition .", "Findings indicate that the Alzheimer 's Association Web site is effective at producing higher scores for AD knowledge relative to no Web site at all and that it is especially helpful for health care workers compared to those who are not health care workers ." ]

[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS" ]

[ "This study aimed to examine the relationship between respiratory health of Malaysian adolescents with secondhand smoke ( SHS ) exposure and smoke-free legislation ( SFL ) implementation .", "A total of 898 students from 21 schools across comprehensive - and partial-SFL states were recruited .", "SHS exposures and respiratory symptoms were assessed via questionnaire .", "Prenatal and postnatal SHS exposure information was obtained from parental-completed questionnaire .", "The prevalence of respiratory symptoms was : 11.9 % ever wheeze , 5.6 % current wheeze , 22.3 % exercise-induced wheeze , 12.4 % nocturnal cough , and 13.1 % self-reported asthma .", "SHS exposure was most frequently reported in restaurants .", "Hierarchical logistic regression indicates living in a comprehensive-SFL state was not associated with a lower risk of reporting asthma symptoms .", "SHS exposure in public transport was linked to increased risk for wheeze ( Adjusted Odds Ratio ( AOR ) 16.6 ; 95 % confidence interval ( CI ) , 2.69-101 .7 ) and current wheezing ( AOR 24.6 ; 95 % CI , 3.53-171 .8 ) .", "Adolescents continue to be exposed to SHS in a range of public venues in both comprehensive - and partial-SFL states .", "Respiratory symptoms are common among those reporting SHS exposure on public transportation .", "Non-compliance with SFL appears to be frequent in many venues across Malaysia and enforcement should be given priority in order to reduce exposure ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The management of psychiatric inpatients exhibiting severely disturbed and aggressive behaviour is an important educational topic .", "Well structured , IT-based educational programmes ( eLearning ) often ensure quality and may make training more affordable and accessible .", "The aim of this study was to explore the impact of an eLearning course for personnel on the rates and duration of seclusion and mechanical restraint among psychiatric inpatients .", "In a cluster-randomized intervention trial , the nursing personnel on 10 wards were randomly assigned to eLearning ( intervention ) or training-as-usual ( control ) groups .", "The eLearning course comprised six modules with specific topics ( legal and ethical issues , behaviour-related factors , therapeutic relationship and self-awareness , teamwork and integrating knowledge with practice ) and specific learning methods .", "The rates ( incidents per 1000 occupied bed days ) and durations of the coercion incidents were examined before and after the course .", "A total of 1283 coercion incidents ( 1143 seclusions [ 89 % ] and 140 incidents involving the use of mechanical restraints [ 11 % ] ) were recorded on the study wards during the data collection period .", "On the intervention wards , there were no statistically significant changes in the rates of seclusion and mechanical restraint .", "However , the duration of incidents involving mechanical restraints shortened from 36.0 to 4.0 h ( median ) ( P < 0.001 ) .", "No statistically significant changes occurred on the control wards .", "After our eLearning course , the duration of incidents involving the use of mechanical restraints decreased .", "However , more studies are needed to ensure that the content of the course focuses on the most important factors associated with the seclusion-related elements .", "The eLearning course deserves further development and further studies .", "The duration of coercion incidents merits attention in future research ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To evaluate whether pretreatment dehydroepiandrosterone ( DHEA ) supplementation improves ovarian response markers , ovarian response to standard low-dose gonadotropin stimulation , and in vitro fertilization ( IVF ) outcomes in poor responders .", "Randomized , double-blind , placebo-controlled pilot study .", "Tertiary reproductive medicine unit .", "Thirty-two women with anticipated poor ovarian response .", "Randomization into DHEA group ( n = 16 ) receiving GNC ( 25 mg three times a day ) or placebo ( n = 16 ) starting from at least 12 weeks before the scheduled IVF treatment according to a computer-generated randomization list .", "Measurement of monthly ovarian response markers , including antral follicle count ( AFC ) , serum antimllerian hormone ( AMH ) , and follicle-stimulating hormone ( FSH ) levels ; comparison of ovarian response to a standard dose of gonadotropin stimulation at week 8 and IVF outcomes ; and AFC after 12 weeks ( primary outcome ) .", "The DHEA supplementation resulted in statistically significantly higher serum DHEA-S , free androgen index , and follicular DHEA-S levels .", "No statistically significant differences in the ovarian response markers ( AFC , AMH , or FSH ) , the ovarian response to standard-dose gonadotropin stimulation , or IVF outcomes were found between the two groups .", "No statistically significant improvement in ovarian response markers , ovarian response to standard dose gonadotropin stimulation , or IVF outcomes was found in poor responders receiving pretreatment DHEA .", "HKCTR-1149 ( www.hkclinicaltrials.com ) and NCT01915186 ( www.ClinicalTrials.org ) ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "To examine the effect of supplementation with probiotics on respiratory and gastrointestinal illness in healthy active men and women .", "A randomised double-blind placebo-controlled trial was conducted .", "Four hundred and sixty five participants ( 241 males ; age 35 12 y ( mean SD ) and 224 females ; age 36 12 y ) were assigned to one of three groups : Group 1 - Bifidobacterium animalis subsp .", "lactis Bl-04 ( Bl-04 ) 2.0 10 ( 9 ) colony forming units per day , CFU per day , Group 2 - Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp .", "lactis Bi-07 ( NCFM & Bi-07 ) 5 10 ( 9 ) CFU each per day ) or Group 3 - placebo mixed in a drink .", "The risk of an upper respiratory illness episode was significantly lower in the Bl-04 group ( hazard ratio 0.73 ; 95 % confidence interval 0.55-0 .95 ; P = 0.022 ) compared to placebo .", "There was no significant difference in illness risk between the NCFM & Bi-07 group ( hazard ratio 0.81 ; 0.62-1 .08 ; P = 0.15 ) and the placebo group .", "There was a 0.7 and 0.9 month delay in the median time to an illness episode in the Bl-04 and NCFM & Bi-07 groups respectively compared to placebo ( placebo 2.5 months ; Bl-04 3.2 months ; NCFM & Bi-07 3.4 months ) .", "There were insufficient GI illness episodes for analysis .", "The NCFM & Bi-07 group but not the Bl-04 group undertook significantly more physical activity ( 8.5 % ; 6.7 % -10 % ; P < 0.003 ) than the placebo group .", "The probiotic Bl-04 appears to be a useful nutritional supplement in reducing the risk of URTI in healthy physically-active adults .", "Australia New Zealand Clinical Trials Registry : Number ACTRN12611000130965 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Hot flushes and night sweats ( vasomotor symptoms ) are common menopausal symptoms , often causing distress , sleep deprivation and reduced quality of life .", "Although hormone replacement therapy is an effective treatment , there are concerns about serious adverse events .", "Non-hormonal pharmacological therapies are less effective and can also cause adverse effects .", "Complementary therapies , including acupuncture , are commonly used for menopausal vasomotor symptoms .", "While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive , acupuncture has a low risk of adverse effects , and two small studies suggest it may be more effective than non-insertive sham acupuncture .", "Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women .", "Our current study design is informed by methods tested in a pilot study .", "This is a stratified , parallel , randomised sham-controlled trial with equal allocation of participants to two trial groups .", "We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency .", "Exclusion criteria include breast cancer , surgical menopause , and current hormone replacement therapy use .", "Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive ( blunt ) needles for ten treatments over eight weeks .", "Participants are blinded to treatment allocation .", "Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures .", "The primary outcome measure is hot flush score , assessed using the validated Hot Flush Diary .", "Secondary outcome measures include health-related quality of life , anxiety and depression symptoms , credibility of the sham treatment , expectancy and beliefs about acupuncture , and adverse events .", "Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy .", "Results from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms .", "If found to be effective and safe , acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms .", "Australian New Zealand Clinical Trials Registry ACTRN12611000393954 11/02/2009 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Insertion of a ventriculoperitoneal shunt ( VPS ) for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK , but failures caused by infection occur in approximately 8 % of primary cases .", "VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service .", "Antibiotic-impregnated ( rifampicin and clindamycin ) and silver-impregnated VPS have been developed to reduce infection rates .", "Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection , there are no randomised controlled trials ( RCTs ) to support their routine use .", "Overall , 1,200 patients will be recruited from 17 regional neurosurgical units in the UK and Ireland .", "Patients of any age undergoing insertion of their first VPS are eligible .", "Patients with previous indwelling VPS , active and on-going cerebrospinal fluid ( CSF ) or peritoneal infection , multiloculated hydrocephalus requiring multiple VPS or neuroendoscopy , and ventriculoatrial or ventriculopleural shunt planned will be excluded .", "Patients will be randomised 1:1:1 to either standard silicone ( comparator ) , antibiotic-impregnated , or silver-impregnated VPS .", "The primary outcome measure is time to VPS infection .", "Secondary outcome measures include time to VPS failure of any cause , reason for VPS failure ( infection , mechanical failure , or patient failure ) , types of bacterial VPS infection ( organism type and antibiotic resistance ) , and incremental cost per VPS failure averted .", "The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial ( the BASICS trial ) is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS .", "The results of this study will be used to inform current neurosurgical practice and may potentially benefit patients undergoing shunt surgery in the future .", "International Standard Randomised Controlled Trial Number : ISRCTN49474281 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "To study the effect of inspiration on airway dimensions measured in voluntary inspiration breath-hold examinations .", "961 subjects with normal spirometry were selected from the Danish Lung Cancer Screening Trial .", "Subjects were examined annually for five years with low-dose CT. .", "Automated software was utilized to segment lungs and airways , identify segmental bronchi , and match airway branches in all images of the same subject .", "Inspiration level was defined as segmented total lung volume ( TLV ) divided by predicted total lung capacity ( pTLC ) .", "Mixed-effects models were used to predict relative change in lumen diameter ( ALD ) and wall thickness ( AWT ) in airways of generation 0 ( trachea ) to 7 and segmental bronchi ( R1-R10 and L1-L10 ) from relative changes in inspiration level .", "Relative changes in ALD were related to relative changes in TLV/pTLC , and this distensibility increased with generation ( p < 0.001 ) .", "Relative changes in AWT were inversely related to relative changes in TLV/pTLC in generation 3 -- 7 ( p < 0.001 ) .", "Segmental bronchi were widely dispersed in terms of ALD ( 5.70.7 mm ) , AWT ( 0.860.07 mm ) , and distensibility ( 23.57.7 % ) .", "Subjects who inspire more deeply prior to imaging have larger ALD and smaller AWT .", "This effect is more pronounced in higher-generation airways .", "Therefore , adjustment of inspiration level is necessary to accurately assess airway dimensions .", "Airway lumen diameter increases and wall thickness decreases with inspiration .", "The effect of inspiration is greater in higher-generation ( more peripheral ) airways .", "Airways of generation 5 and beyond are as distensible as lung parenchyma .", "Airway dimensions measured from CT should be adjusted for inspiration level ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Clopidogrel is indicated for the treatment and prevention of peripheral vascular , cerebrovascular , and coronary artery diseases .", "This clinical trial was designed to demonstrate that clopidogrel napadisilate ( CN ) is not inferior to clopidogrel bisulfate ( CB ) with respect to its effectiveness in inhibiting platelet aggregation .", "This 4 week multi-center , prospective , open-label , randomized trial was conducted at five clinical centers in South Korea .", "Patients were randomized into the 75 mg CN group or the 75mg CB group .", "Platelet aggregation was assessed by the VerifyNow assay .", "The primary outcome was the difference of the percentage P2Y12 inhibition and the secondary outcome was the baseline and change in P2Y12 reaction units ( PRU ) .", "There was no significant difference in the percentage P2Y12 inhibition ( CN vs. CB , 34.92 21.33 % vs. 30.43 17.90 % , p = 0.203 ) .", "The mean difference of the percentage P2Y12 inhibition between groups was 4.49 % , their two-sided 95 % confidence interval was -2.45 % to 11.44 % , and the lower bound ( -2.45 % ) was greater than the acceptable non-inferiority margin of -9.0 % .", "The baseline PRU was 96.67 76.76 in the CN group and 216.95 68.86 in the CB group ( p = 0.121 ) , and the change in the PRU was -3.32 51.71 in the CN group and 10.52 43.31 in the CB group ( p = 0.106 ) .", "Four subjects experienced AEs ( 6.3 % , 5 events ) in the CN group and 7 subjects ( 11.11 % , 13 events ) in the CB group without statistical significance ( p = 0.364 ) .", "With respect to serious adverse events , 2 events were reported in 2 subjects , 1 in each group .", "Clopidogrel napadisilate was not inferior to clopidogrel bisulfate in terms of antiplatelet efficacy and tolerability , and there were no clinically significant adverse events ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Pharmacists may improve medication-related outcomes during transitions of care .", "The aim of the Iowa Continuity of Care Study was to determine if a pharmacist case manager ( PCM ) providing a faxed discharge medication care plan from a tertiary care institution to primary care could improve medication appropriateness and reduce adverse events , rehospitalization and emergency department visits .", "Design .", "Randomized , controlled trial of 945 participants assigned to enhanced , minimal and usual care groups conducted 2007 to 2012 .", "Subjects .", "Participants with cardiovascular-related conditions and/or asthma or chronic obstructive pulmonary disease were recruited from the University of Iowa Hospital and Clinics following admission to general medicine , family medicine , cardiology or orthopedics .", "Intervention .", "The minimal group received admission history , medication reconciliation , patient education , discharge medication list and medication recommendations to inpatient team .", "The enhanced group also received a faxed medication care plan to their community physician and pharmacy and telephone call 3-5 days post-discharge .", "Participants were followed for 90 days post-discharge .", "Main Outcomes and Measures .", "Medication appropriateness index ( MAI ) , adverse events , adverse drug events and post-discharge healthcare utilization were compared by study group using linear and logistic regression , as models accommodating random effects due to pharmacists indicated little clustering .", "Study groups were similar at baseline and the intervention fidelity was high .", "There were no statistically significant differences by study group in medication appropriateness , adverse events or adverse drug events at discharge , 30-day and 90-day post-discharge .", "The average MAI per medication as 0.53 at discharge and increased to 0.75 at 90 days , and this was true across all study groups .", "Post-discharge , about 16 % of all participants experienced an adverse event , and this did not differ by study group ( p > 0.05 ) .", "Almost one-third of all participants had any type of healthcare utilization within 30 days post-discharge , where 15 % of all participants had a 30-day readmission .", "Healthcare utilization post-discharge was not statistically significant different at 30 or 90 days by study group .", "The pharmacist case manager did not affect medication use outcomes post-discharge perhaps because quality of care measures were high in all study groups .", "Clinicaltrials.gov registration : NCT00513903 , August 7 , 2007 ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "Pegloticase is approved in the US for treatment of refractory chronic gout .", "Since chronic kidney disease ( CKD ) is common in these patients , we conducted a post-hoc analysis of 2 replicate phase 3 trials and the subsequent open-label extension study to determine the effects of pegloticase on renal function in patients with CKD stages 3 and 4 , as well as the effects of renal dysfunction on pegloticase efficacy and safety .", "Patients with renal insufficiency were randomized to pegloticase 8mg every 2 weeks ( n = 42 ) , pegloticase 8mg every 4 weeks ( n = 41 ) , or placebo ( n = 20 ) for 6 months as defined by the study protocols .", "Renal function was assessed by estimated glomerular filtration rate ( eGFR ) .", "All patients completing the randomized trials could participate in an open-label extension study for a further 2.5 years .", "Uric acid response , the primary end point in the trials , was plasma uric acid < 6.0 mg/dl for 80 % of months 3 and 6 .", "Mean eGFR in both pegloticase dosing cohorts remained constant over the randomized treatment phase and long-term open-label extension study .", "The number of patients achieving uric acid response was similar across CKD stages ( 32 % stage 1 , 23 % stage 2 , 35 % stage 3 , and 39 % stage 4 , respectively , P = 0.3 ) .", "There was no difference in the pegloticase safety profile based on CKD stage .", "Pegloticase treatment does not impact eGFR in CKD patients and response to pegloticase is independent of CKD stage .", "Clinical trial identifier : NCT00325195 ." ]

[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "The effect of positive vs. negative comments ( praise vs. criticism ) on trainees ' subsequent cognitive and technical performance is unknown , but of potential importance .", "We performed a randomized trial of giving either praise or criticism during simulated normal vaginal deliveries ( using a high-fidelity birthing simulator ) to assess the differential effect of these types of comments on students ' cognitive and technical performance , and perceived confidence after their learning experience .", "Medical and nursing students underwent stratified randomization to praise or criticism .", "Students ( n = 59 ) initially participated in a teaching demonstration and practiced normal spontaneous vaginal delivery using a birthing simulator .", "A baseline assessment of cognitive and technical skills , and of self-confidence , was followed by a second simulation during which positive or negative comments were given using standardized scripts .", "Cognitive performance , technical performance and confidence measures were then scored again .", "Cognitive and technical performance scores in the `` praise '' group improved significantly by 2.5 ( P = 0.007 ) and 1.8 ( P = 0.032 ) , respectively , while those in the `` criticism '' group remained unchanged .", "The self-reported confidence scores did not show any significant change from baseline in either group .", "Praise strengthens students ' cognitive and technical performances , while criticism does not ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Intradermal MVA85A , a candidate vaccine against tuberculosis , induces high amounts of Ag85A-specific CD4 T cells in adults who have already received the BCG vaccine , but aerosol delivery of this vaccine might offer immunological and logistical advantages .", "We did a phase 1 double-blind trial to compare the safety and immunogenicity of aerosol-administered and intradermally administered MVA85A METHODS : In this phase 1 , double-blind , proof-of-concept trial , 24 eligible BCG-vaccinated healthy UK adults were randomly allocated ( 1:1 ) by sequentially numbered , sealed , opaque envelopes into two groups : aerosol MVA85A and intradermal saline placebo or intradermal MVA85A and aerosol saline placebo .", "Participants , the bronchoscopist , and immunologists were masked to treatment assignment .", "The primary outcome was safety , assessed by the frequency and severity of vaccine-related local and systemic adverse events .", "The secondary outcome was immunogenicity assessed with laboratory markers of cell-mediated immunity in blood and bronchoalveolar lavage samples .", "Safety and immunogenicity were assessed for 24 weeks after vaccination .", "Immunogenicity to both insert Ag85A and vector modified vaccinia virus Ankara ( MVA ) was assessed by ex-vivo interferon - ELISpot and serum ELISAs .", "Since all participants were randomised and vaccinated according to protocol , our analyses were per protocol .", "This trial is registered with ClinicalTrials.gov , number NCT01497769 .", "Both administration routes were well tolerated and immunogenic .", "Respiratory adverse events were rare and mild .", "Intradermal MVA85A was associated with expected mild local injection-site reactions .", "Systemic adverse events did not differ significantly between the two groups .", "Three participants in each group had no vaccine-related systemic adverse events ; fatigue ( 11/24 [ 46 % ] ) and headache ( 10/24 [ 42 % ] ) were the most frequently reported symptoms .", "Ag85A-specific systemic responses were similar across groups .", "Ag85A-specific CD4 T cells were detected in bronchoalveolar lavage cells from both groups and responses were higher in the aerosol group than in the intradermal group .", "MVA-specific cellular responses were detected in both groups , whereas serum antibodies to MVA were only detectable after intradermal administration of the vaccine .", "Further clinical trials assessing the aerosol route of vaccine delivery are merited for tuberculosis and other respiratory pathogens .", "The Wellcome Trust and Oxford Radcliffe Hospitals Biomedical Research Centre ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "We recently demonstrated a beneficial effect of metformin compared with glipizide in type 2 diabetic patients regarding cardiovascular outcomes for 3-year treatment in the SPREAD-DIMCAD study .", "However , the potential mechanism for the clinical effects remains unclear .", "Here , we performed a comprehensive lipidomics study to evaluate the different lipid metabolites in serum samples obtained from participants in this study .", "Liquid chromatography-quadrupole time of flight-mass spectrometry was used to evaluate the different lipid metabolites in serum samples obtained from the participants ( 21 patients in glipizide group and 23 patients in metformin group ) before and after each year of treatment ( at 0 [ baseline ] , 1 , 2 , and 3 years of study drug administration ) .", "A total of 118 serum lipid molecular species was identified and quantified .", "During treatment , metformin induced a substantially greater change in serum lipid species compared with glipizide , especially at the 2 - and 3-year time points ( with 2 , 11 , and 12 lipid species being significantly different between the groups after each year of treatment [ 1 , 2 , or 3 years ] , P < 0.05 ) .", "Among the significantly changed lipid species , three lipid metabolites were linked to long-term composite cardiovascular events ( adjusted P < 0.05 ) .", "After treatment , triacylglycerols ( TAGs ) of a relatively higher carbon number showed a clearly increased trend in metformin group compared with the glipizide group , whereas the changes in TAGs with different double bonds were minimal .", "Our findings revealed the differential therapeutic effects of metformin and glipizide on comprehensive lipidomics , which were comparable with their different long-term effects on cardiovascular outcomes ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Proprioception is essential to motor control and joint stability during daily and sport activities .", "Recent studies demonstrated that athletes have better joint position sense ( JPS ) when compared with controls matched for age , suggesting that physical training could have an effect on proprioception .", "To evaluate the result of an 8-week strength-training program on shoulder JPS and to verify whether using training intensities that are the same or divergent for the shoulder 's dynamic-stabilizer muscles promote different effects on JPS .", "Randomized controlled clinical trial .", "We evaluated JPS in a research laboratory and conducted training in a gymnasium .", "A total of 90 men , right handed and asymptomatic , with no history of any type of injury or shoulder instability .", "For 8 weeks , the participants performed the strength-training program 3 sessions per week .", "We used 4 exercises ( bench press , lat pull down , shoulder press , and seated row ) , with 2 sets each .", "We measured shoulder JPS acuity by calculating the absolute error .", "We found an interaction between group and time .", "To examine the interaction , we conducted two 1-way analyses of variance comparing groups at each time .", "The groups did not differ at pretraining ; however , a difference among groups was noted posttraining .", "Strength training using exercises at the same intensity produced an improvement in JPS compared with exercises of varying intensity , suggesting that the former resulted in improvements in the sensitivity of muscle spindles and , hence , better neuromuscular control in the shoulder ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Covered nitinol alloy self-expandable metal stents ( SEMSs ) have been developed to overcome the shortcomings of steel SEMS in patients with malignant biliary obstruction .", "In a randomized , multicenter trial , we compared stent patency , patient survival , and adverse events in patients with partly covered stents made from steel or nitinol .", "A total of 400 patients with unresectable distal malignant biliary obstruction were randomized at endoscopic retrograde cholangiopancreatography ( ERCP ) to insertion of a steel or nitinol partially covered SEMS , with 200 patients in each group.The primary outcome was confirmed stent failure during 300 days of follow-up .", "At 300 days , the proportion of patients with patent stents was 77 % in the steel group , compared with 89 % in the nitinol group ( P = 0.01 ) .", "Confirmed stent failure occurred more often in the steel SEMS group compared with the nitinol SEMS group , in 30 versus 14 patients ( P = 0.02 ) .", "Stent migration occurred in 13 patients in the steel group and in 3 patients in the nitinol group ( P = 0.01 ) .", "Median patient survival ( secondary outcome ) was 137 days and 120 days in the steel SEMS and nitinol SEMS groups , respectively ( P = 0.59 ) .", "The nitinol SEMS showed longer patency time , and the nitinol group had fewer patients with stent failure , compared with the steel SEMS group .", "We could not detect any differences between the two groups regarding survival time , and regarding adverse event rate.Clinical trial registration : NCT 00980889 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To evaluate the combined effect of premedication of parecoxib sodium and local infiltration of ropivocaine on postoperative shoulder pain and incisional pain in patients undergoing diagnostic hysteroscopy and laparoscopy .", "In the study , 60 patients undergoing elective diagnostic hysteroscopy and laparoscopy were randomly allocated to two groups ( each with 30 patients ) .", "The patients in group 1 were premedicated with 40 mg parecoxib sodium ( diluted with 2 mL normal saline ) , and 0.5 % ropivacaine ( 20 mL ) were infiltrated around the incision site before establishment of CO2 pneumoperitoneum .", "The patients in group 2 received 2 mL normal saline intraveniously before anesthesia induction , and infiltration of 0.5 % ropivacaine 20 mL were also applied as group 1 .", "After anesthetic withdrawal , the patients ' postoperative anesthesia recovery time and the time point of opening eyes on verbal command were noted .", "The intensities of postoperative shoulder pain and incisional pain were evaluated at 0 , 2 , 4 , 8 , 12 , 24 , and 48 h after surgery .", "The postoperative analgesic requirement was met by administration of tramadol .", "Compared with group 2 , the incidence of postoperative shoulder pain was less in group 1 ( 37 % vs. 67 % , P = 0.020 ) , and the occurence of severe pain was lower ( 4 vs. 11 , P = 0.037 ) .", "The numerical rating scales ( NRS ) of right shoulder pain of group 1 were significantly reduced than those of group 2 at 12 h postoperatively [ 0 ( 0 , 2 ) vs. 0 ( 0 , 8 ) , P = 0.012 ] .", "Left shoulder pain did not appear at 0 h and 2 h in both groups , while at 12 h and 24 h postoperatively , the NRS scores of group 1 were lower than those of group 2 [ 0 ( 0 , 1 ) vs. 0 ( 0 , 8 ) , P = 0.026 ; 0 ( 0 , 4 ) vs. 2 ( 0 , 9 ) , P = 0.014 ] .", "The dynamic and static abdominal pain scores of group 1 were significantly decreased than those of group 2 in post-anesthesia care unit ( PACU ) after surgery ( P = 0.001 , P = 0.005 ) .", "The NRS scores of static abdominal pain of group 1 were significantly reduced than those of group 2 at 12 h and 24 h postoperatively ( P = 0.042 , P = 0.029 ) .", "More patients in group 2 needed tramadol within 24 h postoperatively ( 8 vs. 0 , P = 0.002 ) .", "Premedication of parecoxib sodium combined with local infiltration of ropinvocaine before incision could significantly reduce the postoperative shoulder pain and incisional pain as well as reduce opioid consumption in patients undergoing diagnostic hysteroscopy and laparoscopy ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The use of live attenuated varicella vaccine ( Varilrix ( ) ) as an adjuvant treatment in severe cases of psoriasis has recently been postulated .", "Its efficacy raised questions regarding its possible mechanisms of action .", "To compare the efficacy and safety of combining Varilrix ( ) and cyclosporine to cyclosporine alone in the treatment of severe psoriasis .", "Furthermore , to study the expression of T helper ( Th ) 17 and T regulatory ( Tregs ) cells before and after therapy .", "This randomized controlled trial included 24 psoriatic patients , randomly divided into 2 groups ( A and B ) .", "All patients received cyclosporine at a daily dose of 2.5 mg/kg/day .", "In addition , group A received 4 doses of Varilrix ( ) once/3 weeks , and group B received 4 doses of subcutaneous saline .", "Skin biopsies were obtained from all patients before and after therapy and from all controls for estimation of interleukin ( IL ) -17 , IL-22 and Forkhead boxP3 ( FoxP3 ) using RT-PCR .", "Group A patients showed a significantly higher % of clinical improvement ( P = 0.011 ) , which occurred earlier than group B.", "At baseline , levels of IL-17 and IL-22 were significantly higher while the level of FoxP3 was significantly lower in patients ( P < 0.001 ) compared to controls .", "After therapy , both groups showed significant reductions in both IL-17 and IL-22 levels , and significant elevation in FoxP3 ( P < 0.001 ) .", "This change was significantly more evident in group A patients .", "Live attenuated varicella vaccine could play a role in the treatment of psoriasis when combined with low dose cyclosporine through accentuating the influence on the Th17/Treg balance ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Exercise is beneficial for breast cancer patients during chemotherapy but adherence to different types and doses of exercise is a challenge .", "The purpose of this study was to examine predictors of adherence to different types and doses of exercise during breast cancer chemotherapy in a multicenter randomized controlled trial .", "Breast cancer patients in Edmonton , Vancouver , and Ottawa , Canada receiving chemotherapy ( N = 301 ) were randomized to a standard dose of 25-30 minutes of aerobic exercise ( STAN ) , a higher dose of 50-60 minutes of aerobic exercise ( HIGH ) , or a higher dose of 50-60 minutes of combined aerobic and resistance exercise ( COMB ) .", "Predictors included demographic , medical , fitness , and quality of life variables .", "Exercise adherence was measured as the percentage of supervised exercise sessions completed .", "Overall adherence to the supervised exercise sessions was 73 % ( SD = 24 % ) .", "In a multivariate regression model , six independent predictors explained 26.4 % ( p < 0.001 ) of the variance in exercise adherence .", "Higher exercise adherence was achieved by breast cancer patients in Vancouver ( p < 0.001 ) , with fewer endocrine symptoms ( p = 0.009 ) , randomized to STAN ( p = 0.009 ) , with fewer exercise limitations ( p = 0.009 ) , receiving shorter chemotherapy protocols ( p = 0.015 ) , and with higher VO2peak ( p = 0.017 ) .", "Disease stage ( p for interaction = 0.015 ) and body mass index ( p for interaction = 0.030 ) interacted with group assignment to predict adherence .", "For disease stage , patients with stage I/IIa disease adhered equally well to all three exercise interventions whereas patients with stage IIb/III disease adhered better to the STAN intervention than the two higher dose exercise interventions .", "For body mass index , healthy weight patients adhered equally well to all three exercise interventions whereas overweight patients adhered best to STAN and worst to COMB ; and obese patients adhered best to STAN and worst to HIGH .", "Determinants of exercise adherence in breast cancer patients receiving chemotherapy are multidisciplinary and may vary by the exercise prescription ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "A live oral cholera vaccine VA 1.4 developed from a non-toxigenic Vibrio cholerae O1 El Tor strain using ctxB gene insertion was further developed into a clinical product following cGMP and was evaluated in a double-blind randomized placebo controlled parallel group two arm trial with allocation ratio of 11 for safety and immunogenicity in men and women aged 18-60 years from Kolkata , India .", "A lyophilized dose of 1.9109 CFU ( n = 44 ) or a placebo ( n = 43 ) reconstituted with a diluent was administered within 5 minutes of drinking 100 ml of a buffer solution made of sodium bicarbonate and ascorbic acid and a second dose on day 14 .", "The vaccine did not elicit any diarrhea related adverse events .", "Other adverse events were rare , mild and similar in two groups .", "One subject in the vaccine group excreted the vaccine strain on the second day after first dose .", "The proportion of participants who seroconverted ( i.e. had 4-folds or higher rise in reciprocal titre ) in the vaccine group were 65.9 % ( 95 % CI : 50.1 % -79.5 % ) at both 7 days ( i.e. after 1st dose ) and 21 days ( i.e. after 2nd dose ) .", "None of the placebo recipients seroconverted .", "Anti-cholera toxin antibody was detected in very few recipients of the vaccine .", "This study demonstrates that VA 1.4 at a single dose of 1.9109 is safe and immunogenic in adults from a cholera endemic region .", "No additional benefit after two doses was seen .", "Clinical Trials Registry-India , National Institute of Medical Statistics ( Indian Council of Medical Research ) CTRI/2012/04 / 002582 ." ]

[ "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The objective of this study was to evaluate the efficacy of belinostat , a histone deacetylase inhibitor , when added to paclitaxel/carboplatin in the empiric first-line treatment of patients with carcinoma of unknown primary site ( CUP ) .", "In this randomized phase 2 trial , previously untreated patients with CUP were randomized to receive belinostat plus paclitaxel/carboplatin ( group A ) or paclitaxel/carboplatin alone ( group B ) repeated every 21 days .", "Patients were re-evaluated every 2 cycles , and those without disease progression continued treatment for 6 cycles .", "Patients in group A then continued receiving single-agent belinostat , whereas patients in group B stopped treatment .", "The primary endpoint was progression-free survival ( PFS ) : The authors postulated that the addition of belinostat would improve PFS from 5 months ( expected with paclitaxel/carboplatin ) to 8 months .", "In total , 89 patients were randomized ( group A , n = 44 ; group B , n = 45 ) , and the demographics and disease characteristics were balanced between the 2 groups .", "The addition of belinostat to paclitaxel/carboplatin did not improve PFS ( group A , 5.4 months [ 95 % confidence interval , 3.0-6 .0 months ] ; group B , 5.3 months [ 95 % confidence interval , 2.8-6 .6 months ] ; P = .85 ) .", "Overall survival was 12.4 months for group A versus 9.1 months for group B ( P = .20 ) .", "The response rate favored the belinostat group ( 45 % vs 21 % ; P = .02 ) .", "Belinostat resulted in a modest increase in treatment toxicity .", "The addition of belinostat to paclitaxel/carboplatin did not improve the PFS of patients with CUP who were receiving first-line therapy , although the patients who received belinostat had a higher investigator-assessed response rate .", "Future trials in CUP should focus on specific subsets , defined either by the predicted tissue of origin or by the identification of targetable molecular abnormalities ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Epidemiological and toxicological evidence suggests lower risk of smokeless tobacco ( ST ) products compared to cigarettes .", "Less is known , however , about consumer perceptions and use of novel forms of ST , including snus and dissolvable tobacco .", "In this study , we conducted in-person experimental auctions in Buffalo , NY , Columbia , SC , and Selinsgrove , PA with 571 smokers to test the impact of information and product trials on smokers ' preferences .", "Auctions were conducted between November 2010-November 2011 .", "We found no evidence of an impact of product trials on demand in our auctions .", "Anti-ST information increased demand for cigarettes when presented alone , but when presented with pro-ST information it decreased demand for cigarettes .", "It did not decrease demand for ST products .", "Anti-smoking information increased demand for ST products , but did not affect cigarette demand .", "These findings suggest that credible and effective communications about tobacco harm reduction should reinforce the negative effects of smoking ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH-LUTS ) with tadalafil using two definitions of response .", "Post hoc integrated analysis of four placebo-controlled studies in men ( aged 45 years ; International Prostate Symptom Score [ IPSS ] of 13 ; maximum urinary flow rate [ Q ( max ) ] of 4 to 15 mL/s ) with BPH-LUTS randomised to tadalafil 5 mg ( 752 patients ) or placebo ( 747 ) for 12 weeks after a 4-week placebo run-in .", "Responders were defined as having a total IPSS improvement of 3 points or 25 % from randomisation to endpoint ( Week 12 ) .", "Response status was calculated per patient , and relative benefit and odds ratio ( OR ) with 95 % confidence interval ( CI ) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures .", "Tadalafil 5 mg once daily resulted in a significantly greater proportion of patients achieving a 3-point IPSS improvement ( 71.1 % and 56.0 % for tadalafil and placebo patients , respectively [ OR 1.9 , 95 % CI 1.5 , 2.4 ; P < 0.001 ] ) and achieving a 25 % improvement in total IPSS randomisation to endpoint ( 61.7 % and 45.5 % for tadalafil and placebo patients , respectively [ OR 2.0 , 95 % CI 1.6 , 2.5 ; P < 0.001 ] ) .", "About two-thirds of tadalafil-treated patients achieve a clinically meaningful improvement in BPH-LUTS symptoms , based on two different definitions of responder status ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "We investigated the longitudinal association of depression , with and without cognitive dysfunction , with hemoglobin A1c ( HbA1c ) , systolic blood pressure ( SBP ) , and low-density lipoprotein ( LDL ) in a predominantly minority cohort .", "There were 613 participants .", "Presence of depression was defined by a score 7 on the Short-CARE depression scale .", "We tested participants for executive dysfunction using the Color Trails Test ( CTT ) , part 2 , and for memory dysfunction using the total recall task of the Selective Reminding Test ( TR-SRT ) .", "We classified performance in these tests as abnormal based on standardized score cutoffs ( < 16th percentile and one standard deviation below the sample mean ) .", "Random effects models were used to compare repeated measures of the diabetes control measures between those with depression versus those without depression and ever versus never cognitively impaired .", "Baseline depression was present in 36 % of participants .", "Over a median follow-up of 2 years , depression was not related to worse HbA1c , SBP , or LDL .", "The presence of ( 1 ) abnormal performance on a test of executive function and depression ( n = 57 ) or ( 2 ) abnormal performance on a test of verbal recall and depression ( n = 43 ) was also not associated with clinically significant worse change in diabetes control .", "Depression , with or without low performance in tests of executive function and memory , may not affect clinically significant measures of diabetes control in the elderly ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To investigate the long-term safety and maintenance of efficacy of monotherapy with once-daily zonisamide versus twice-daily controlled-release carbamazepine for partial seizures in adults with newly diagnosed epilepsy .", "Long-term , double-blind , extension study , conducted in patients completing a phase III noninferiority trial comparing zonisamide and carbamazepine monotherapy .", "Patients continued their randomized treatment , with dosing adjusted according to tolerability/response ( zonisamide 200-500 mg/day ; carbamazepine 400-1 ,200 mg/day ) .", "Safety assessments included treatment-emergent adverse events ( TEAEs ) and clinical laboratory parameters .", "Efficacy assessments included retention rate and the proportion of patients remaining seizure free for 24 months .", "Overall , 120 ( 87.6 % ) of 137 patients randomized to zonisamide and 134 ( 84.8 % ) of 158 patients randomized to carbamazepine completed the study .", "More than three-fourths of patients were exposed to > 24 months of treatment .", "For zonisamide versus carbamazepine , incidences were similar for TEAEs ( 52.6 % vs. 46.2 % ) , serious treatment-related TEAEs ( 0.7 % vs. 1.9 % ) , and TEAEs leading to withdrawal ( 1.5 % vs. 0.6 % ) .", "The incidence of treatment-related TEAEs was 26.3 % for zonisamide compared with 19.6 % for carbamazepine , and the most frequently reported treatment-related TEAEs were decreased weight ( 5.1 % vs. 0 % ) , decreased appetite ( 3.6 % vs. 0 % ) , memory impairment ( 2.9 % vs. 3.2 % ) , and decreased hemoglobin level ( 1.5 % vs. 3.2 % ) .", "Most TEAEs were of mild or moderate intensity .", "There were no reports of Stevens-Johnson syndrome or toxic epidermal necrolysis in either group .", "Zonisamide was associated with small-to-moderate decreases in bicarbonate levels from baseline ( mean -3.4 mm ) .", "There were no reports of metabolic acidosis .", "Retention rates were generally similar between treatment groups at all time points throughout the extension study .", "The proportion of patients remaining seizure free for 24 months was also similar for zonisamide ( 32.3 % ) and carbamazepine ( 35.2 % ) .", "Once-daily zonisamide monotherapy demonstrated favorable long-term safety and maintenance of efficacy in treating partial seizures in adults with newly diagnosed epilepsy .", "No new or unexpected safety findings emerged ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Inflammatory response during sepsis is incompletely understood due to small sample sizes and variable timing of measurements following the onset of symptoms .", "The vasopressin in septic shock trial ( VASST ) compared the addition of vasopressin to norepinephrine alone in patients with septic shock .", "During this study plasma was collected and 39 cytokines measured in a 363 patients at both baseline ( before treatment ) and 24 hours .", "Clinical features relating to both underlying health and the acute organ dysfunction induced by the severe infection were collected during the first 28 days of admission .", "Cluster analysis of cytokines identifies subgroups of patients at differing risk of death and organ failure .", "Circulating cytokines and other signaling molecules were measured using a Luminex multi-bead analyte detection system .", "Hierarchical clustering was performed on plasma values to create patient subgroups .", "Enrichment analysis identified clinical outcomes significantly different according to these chemically defined patient subgroups .", "Logistic regression was performed to assess the importance of cytokines for predicting patient subgroups .", "Plasma levels at baseline produced three subgroups of patients , while 24 hour levels produced two subgroups .", "Using baseline cytokine data , one subgroup of 47 patients showed a high level of enrichment for severe septic shock , coagulopathy , renal failure , and risk of death .", "Using data at 24 hours , a larger subgroup of 81 patients that largely encompassed the 47 baseline subgroup patients had a similar enrichment profile .", "Measurement of two cytokines , IL2 and CSF2 and their product were sufficient to classify patients into these subgroups that defined clinical risks .", "A distinct pattern of cytokine levels measured early in the course of sepsis predicts disease outcome .", "Subpopulations of patients have differing clinical outcomes that can be predicted accurately from small numbers of cytokines .", "Design of clinical trials and interventions may benefit from consideration of cytokine levels ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Nasal packing is usually performed to control bleeding after endoscopic sinus surgery ( ESS ) .", "Although new packing materials have been developed , they still cause pain .", "This study was designed to evaluate the effect of lidocaine-soaked packs on pain after ESS .", "A prospective , randomized , double-blind controlled trial was conducted in 63 patients with CRS undergoing ESS .", "At the conclusion of the operation , 2 % lidocaine-soaked biodegradable synthetic polyurethane foam and saline-soaked polyurethane foam were inserted in both nasal cavities of 31 patients and 32 control patients , respectively .", "The same lidocaine or saline was reapplied into the nasal packs at postoperative 8 hours .", "Pain was evaluated using a visual analog scale at postoperative 1 , 4 , 8 , 16 , 20 , and 24 hour ( s ) .", "The number of gauze that cleaned the blood around the nose was counted .", "Heart rate , rhythm , and blood pressures were checked preoperatively and postoperatively to evaluate the influence of lidocaine on vital signs .", "Postoperative pain decreased in lidocaine group at all of the postoperative time periods ( p < 0.05 ) .", "Lidocaine reduced postoperative bleeding at postoperative 8 and 24 hours .", "Changes of blood pressure from preoperative values in the lidocaine group were not different from those in the control group ( p > 0.05 ) .", "Heart rate in the lidocaine group was more stable than that in the control group ( p < 0.05 ) .", "Lidocaine-soaked packs significantly reduced postoperative pain without serious changes on vital sign .", "These findings suggest that topical lidocaine application to nasal packs could be a useful method to reduce pain during the early postoperative period after ESS ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The anti-influenza virus activity of green tea catechins has been demonstrated in experimental studies , but clinical evidence has been inconclusive .", "School-aged children play an important role in the infection and spread of influenza in the form of school-based outbreaks .", "Preventing influenza infection among students is essential for reducing the frequency of epidemics and pandemics .", "As a non-pharmaceutical intervention against infection , gargling is also commonly performed in Asian countries but has not yet been extensively studied .", "A randomized , open label , 2-group parallel study of 757 high school students ( 15 to 17 years of age ) was conducted for 90 days during the influenza epidemic season from December 1st , 2011 to February 28th , 2012 , in 6 high schools in Shizuoka Prefecture , Japan .", "The green tea gargling group gargled 3 times a day with bottled green tea , and the water gargling group did the same with tap water .", "The water group was restricted from gargling with green tea .", "The primary outcome measure was the incidence of laboratory-confirmed influenza using immunochromatographic assay for antigen detection .", "757 participants were enrolled and 747 participants completed the study ( 384 in the green tea group and 363 in the water group ) .", "Multivariate logistic regression indicated no significant difference in the incidence of laboratory-confirmed influenza between the green tea group ( 19 participants ; 4.9 % ) and the water group ( 25 participants ; 6.9 % ) ( adjusted OR , 0.69 ; 95 % CI , 0.37 to 1.28 ; P = 0.24 ) .", "The main limitation of the study is the adherence rate among high school students was lower than expected .", "Among high school students , gargling with green tea three times a day was not significantly more efficacious than gargling with water for the prevention of influenza infection .", "In order to adequately assess the effectiveness of such gargling , additional large-scale randomized studies are needed .", "ClinicalTrials.gov NCT01225770 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The purpose of this study is to investigate the effects of urocortin-2 as adjunct therapy in acute decompensated heart failure ( ADHF ) .", "Urocortin-2 produced favorable integrated effects in experimental heart failure but there are no equivalent human data .", "We describe the first therapeutic study of urocortin-2 infusion in ADHF .", "Fifty-three patients with ADHF were randomly assigned to 5 ng/kg/min of urocortin-2 or placebo infusion for 4 h as an adjunct therapy .", "Changes in vital signs , plasma neurohormonal and renal indices during treatment were compared using repeated-measures analysis of covariance .", "Ten patients in each arm underwent more detailed invasive hemodynamic evaluation .", "Urocortin-2 produced greater falls in systolic blood pressure compared to placebo ( 16 5.8 mm Hg , p < 0.001 ) with nonsignificant increases in heart rate ( 5.7 3.8 beats/min , p = 0.07 ) and increased cardiac output ( 2.1 0.4 l/min vs. -0.1 0.4 l/min , p < 0.001 ) associated with a 47 % reduction in calculated total peripheral resistance ( p = 0.015 ) .", "Falls in pulmonary artery and pulmonary capillary wedge pressures did not differ significantly between groups .", "Urocortin-2 reduced urine volume and creatinine clearance during infusion but these returned to above baseline level in the 8 h after infusion .", "Plasma renin activity rose briefly with urocortin-2 coinciding with reductions in blood pressure ( p < 0.001 ) .", "B-type natriuretic peptide levels fell significantly over 24 h with urocortin-2 ( p < 0.01 ) but not with placebo .", "Urocortin-2 infusion in ADHF markedly augmented cardiac output without significant reflex tachycardia .", "Renal indices fell transiently concurrent with urocortin-2-induced reductions in blood pressure .", "Further investigations are required to uncover the full potential of urocortin-2 in treating ADHF ." ]

[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Many HIV-infected pregnant women identified during antenatal care ( ANC ) do not enroll in long-term HIV care , resulting in deterioration of maternal health and continued risk of HIV transmission to infants .", "We performed a cluster randomized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya .", "Twelve facilities were randomized to provide either integrated services ( ANC , prevention of mother-to-child transmission , and HIV care delivered in the ANC clinic ; n = 6 intervention facilities ) or standard ANC services ( including prevention of mother-to-child transmission and referral to a separate clinic for HIV care ; n = 6 control facilities ) .", "There were high patient attrition rates over the course of this study .", "Among study participants who enrolled in HIV care , there was 12-month follow-up data for 256 of 611 ( 41.8 % ) women and postpartum data for only 325 of 1172 ( 28 % ) women .", "By 9 months of age , 382 of 568 ( 67.3 % ) infants at intervention sites and 338 of 594 ( 57.0 % ) at control sites had tested for HIV [ odds ratio ( OR ) 1.45 , 95 % confidence interval ( CI ) : 0.71 to 2.82 ] ; 7.3 % of infants tested HIV positive at intervention sites compared with 8.0 % of infants at control sites ( OR 0.89 , 95 % CI : 0.56 to 1.43 ) .", "The composite clinical/immunologic progression into AIDS was similar in both arms ( 4.9 % vs. 5.1 % , OR 0.83 , 95 % CI : 0.41 to 1.68 ) .", "Despite the provision of integrated services , patient attrition was substantial in both arms , suggesting barriers beyond lack of service integration .", "Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes ." ]

[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "It is still unclear whether D2 lymphadenectomy improves the survival of patients with gastric cancer and should therefore be performed routinely or selectively .", "The aim of this multicentre randomized trial was to compare D2 and D1 lymphadenectomy in the treatment of gastric cancer .", "Between June 1998 and December 2006 , patients with gastric adenocarcinoma were assigned randomly to either D1 or D2 gastrectomy .", "Intraoperative randomization was implemented centrally by telephone .", "Primary outcome was overall survival ; secondary endpoints were disease-specific survival , morbidity and postoperative mortality .", "A total of 267 eligible patients were allocated to either D1 ( 133 patients ) or D2 ( 134 ) resection .", "Morbidity ( 12.0 versus 17.9 per cent respectively ; P = 0.183 ) and operative mortality ( 3.0 versus 2.2 per cent ; P = 0.725 ) rates did not differ significantly between the groups .", "Median follow-up was 8.8 ( range 4.5-13 .1 ) years for surviving patients and 2.4 ( 0.2-11 .9 ) years for those who died , and was not different in the two treatment arms .", "There was no difference in the overall 5-year survival rate ( 66.5 versus 64.2 per cent for D1 and D2 lymphadenectomy respectively ; P = 0.695 ) .", "Subgroup analyses showed a 5-year disease-specific survival benefit for patients with pathological tumour ( pT ) 1 disease in the D1 group ( 98 per cent versus 83 per cent for the D2 group ; P = 0.015 ) , and for patients with pT2-4 status and positive lymph nodes in the D2 group ( 59 per cent versus 38 per cent for the D1 group ; P = 0.055 ) .", "No difference was found in overall 5-year survival between D1 and D2 resection .", "Subgroup analyses suggest that D2 lymphadenectomy may be a better choice in patients with advanced disease and lymph node metastases .", "ISRCTN11154654 ( http://www.controlled-trials.com ) ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Patients with lymphoma are at higher-risk of secondary malignancies mainly due to effects of cancer therapy as well as frequent radiological surveillance .", "We thus aimed to investigate the objective and subjective image quality as well as radiation exposure and risk of full-dose standard ( FDS ) , full-dose iterative ( FDI ) , and half-dose iterative ( HDI ) image reconstruction in patients with lymphoma .", "In 100 lymphoma patients , contrast-enhanced whole-body staging was performed on a dual-source CT. .", "To acquire full-dose and half-dose CT data simultaneously , the total current-time product was equally distributed on both tubes operating at 120 kV .", "HDI reconstructions were calculated by using only data from one tube .", "Quantitative image quality was assessed by measuring image noise in different tissues of the neck , thorax , and abdomen .", "Overall diagnostic image quality was assessed using a 5-point Likert scale .", "Radiation doses and risks were estimated for a male and female reference person .", "For all anatomical regions apart from the lungs image noise was significantly lower and the overall subjective image quality significantly better when using FDI and HDI instead of FDS reconstruction ( p < 0.05 ) .", "For the half-dose protocol , the risk to develop a radiation-induced cancer was estimated to be less than 0.11 / 0.19 % for an adult male/female .", "Image quality of FDI and more importantly of HDI is superior to FDS reconstruction , thus enabling to halve radiation dose and risk to lymphoma patients ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The aim of this study was to investigate the potential benefits of an extract obtained from seeds/fruits of an Oleaceae ( Fraxinus excelsior L. ) on glucose homeostasis and associated metabolic markers in non-diabetic overweight/obese subjects .", "This study was performed in 22 participants ( 50-80 years-old ; BMI 31.0 kg/m ( 2 ) ) .", "The design was a longitudinal , randomized , crossover , double-blind , placebo-controlled 7-week nutritional intervention .", "The participants received daily 3 capsules each containing either 333 mg of an extract from Fraxinus excelsior L. seeds ( Glucevia ( ) ) or placebo capsules ( control ) in a random order for 3 weeks with 1 week of washout between treatments .", "Moreover , they followed a balanced covert energy-restricted diet ( -15 % energy ) .", "All variables were measured at the beginning and at the end of each period .", "Compared to baseline , the administration of 1 g of Glucevia ( ) for 3 weeks resulted in significantly lower incremental glucose area under the curve ( -28.2 % ; p < 0.01 ) , and significantly lower 2 h blood glucose values ( -14 % ; p < 0.01 ) following an oral glucose tolerance test .", "No significant changes were found in the control group ( -7.9 % AUC , -1.6 % 2h blood glucose ) .", "Furthermore , significant differences were found between responses in the control and Glucevia ( ) groups with respect to serum fructosamine and plasma glucagon levels ( p < 0.01 and p < 0.05 , respectively ) .", "Interestingly , administration of Glucevia ( ) significantly increased the adiponectin : leptin ratio ( p < 0.05 ) and decreased fat mass ( p < 0.01 ) compared to control ( p < 0.05 ) .", "The administration of an extract from Fraxinus excelsior L. seeds/fruits in combination with a moderate hypocaloric diet may be beneficial in metabolic disturbances linked to impaired glucose tolerance , obesity , insulin resistance and inflammatory status , specifically in older adults ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "With modern initial aggressive combination treatments with synthetic disease-modifying antirheumatic drugs ( sDMARD ) , most patients with rheumatoid arthritis ( RA ) achieve remission , have marginal radiographic progression , and sustain normal function .", "Here we aim to identify the patients failing these targets even after aggressive treatment .", "Ninety-nine patients with early , active RA were treated with a combination of 3 sDMARD and prednisolone ( PRD ) , and either infliximab or placebo infusions during the first 6 months , aiming at strict remission .", "After 24 months , the treatments became unrestricted .", "At 60 months , 4 evident clinical features of treatment failure were defined : area under curve ( AUC ) between 6-60 months for disease activity score assessing 28 joints > 2.6 ; AUC 6-60 for health assessment questionnaire > 0.5 ; progression in total Sharp/van der Heijde score 0-60 months > 3 units ; and need of PRD or biologic DMARD treatment at 60 months .", "A total of 93 patients were followed up for 60 months .", "Of them , 45 had no features of treatment failure , 30 had 1 , 10 had 2 , 7 had 3 , and 1 patient had all 4 features .", "Having 2-4 features of treatment failure at 5 years was predicted by the health assessment score at baseline , and by even low residual disease activity at 3 and 6 months .", "Only 20 % of the patients with RA treated early with combination sDMARD and PRD have more than 1 clinical feature of treatment failure at 60 months .", "Residual clinical disease activity at 3-6 months was the most important predictor for identifying these patients .", "The study was registered at www.clintrials.gov ( NCT00908089 ) ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Anxiety , depressive and substance use disorders account for three quarters of the disability attributed to mental disorders and frequently co-occur .", "While programs for the prevention and reduction of symptoms associated with ( i ) substance use and ( ii ) mental health disorders exist , research is yet to determine if a combined approach is more effective .", "This paper describes the study protocol of a cluster randomised controlled trial to evaluate the effectiveness of the CLIMATE Schools Combined intervention , a universal approach to preventing substance use and mental health problems among adolescents .", "Participants will consist of approximately 8400 students aged 13 to 14-years-old from 84 secondary schools in New South Wales , Western Australia and Queensland , Australia .", "The schools will be cluster randomised to one of four groups ; ( i ) CLIMATE Schools Combined intervention ; ( ii ) CLIMATE Schools - Substance Use ; ( iii ) CLIMATE Schools - Mental Health , or ( iv ) Control ( Health and Physical Education as usual ) .", "The primary outcomes of the trial will be the uptake and harmful use of alcohol and other drugs , mental health symptomatology and anxiety , depression and substance use knowledge .", "Secondary outcomes include substance use related harms , self-efficacy to resist peer pressure , general disability , and truancy .", "The link between personality and substance use will also be examined .", "Compared to students who receive the universal CLIMATE Schools - Substance Use , or CLIMATE Schools - Mental Health or the Control condition ( who received usual Health and Physical Education ) , we expect students who receive the CLIMATE Schools Combined intervention to show greater delays to the initiation of substance use , reductions in substance use and mental health symptoms , and increased substance use and mental health knowledge .", "This trial is registered with the Australian and New Zealand Clinical Trials registry , ACTRN12613000723785 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "Hyperkalemia increases the risk of death and limits the use of inhibitors of the renin-angiotensin-aldosterone system ( RAAS ) in high-risk patients .", "We assessed the safety and efficacy of patiromer , a nonabsorbed potassium binder , in a multicenter , prospective trial .", "Patients with chronic kidney disease who were receiving RAAS inhibitors and who had serum potassium levels of 5.1 to less than 6.5 mmol per liter received patiromer ( at an initial dose of 4.2 g or 8.4 g twice a day ) for 4 weeks ( initial treatment phase ) ; the primary efficacy end point was the mean change in the serum potassium level from baseline to week 4 .", "Eligible patients at the end of week 4 ( those with a baseline potassium level of 5.5 to < 6.5 mmol per liter in whom the level decreased to 3.8 to < 5.1 mmol per liter ) entered an 8-week randomized withdrawal phase in which they were randomly assigned to continue patiromer or switch to placebo ; the primary efficacy end point was the between-group difference in the median change in the serum potassium level over the first 4 weeks of that phase .", "In the initial treatment phase , among 237 patients receiving patiromer who had at least one potassium measurement at a scheduled visit after day 3 , the mean ( SE ) change in the serum potassium level was -1.010.03 mmol per liter ( P < 0.001 ) .", "At week 4 , 76 % ( 95 % confidence interval , 70 to 81 ) of the patients had reached the target potassium level ( 3.8 to < 5.1 mmol per liter ) .", "Subsequently , 107 patients were randomly assigned to patiromer ( 55 patients ) or placebo ( 52 patients ) for the randomized withdrawal phase .", "The median increase in the potassium level from baseline of that phase was greater with placebo than with patiromer ( P < 0.001 ) ; a recurrence of hyperkalemia ( potassium level , 5.5 mmol per liter ) occurred in 60 % of the patients in the placebo group as compared with 15 % in the patiromer group through week 8 ( P < 0.001 ) .", "Mild-to-moderate constipation was the most common adverse event ( in 11 % of the patients ) ; hypokalemia occurred in 3 % .", "In patients with chronic kidney disease who were receiving RAAS inhibitors and who had hyperkalemia , patiromer treatment was associated with a decrease in serum potassium levels and , as compared with placebo , a reduction in the recurrence of hyperkalemia .", "( Funded by Relypsa ; OPAL-HK ClinicalTrials.gov number , NCT01810939 . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The implementation of healthy school canteen policies has been recommended as a strategy to help prevent unhealthy eating and excessive weight gain .", "Internationally , research suggests that schools often fail to implement practices consistent with healthy school canteen policies .", "Without a population wide implementation , the potential benefits of these policies will not be realised .", "The aim of this trial is to assess the effectiveness of an implementation intervention in increasing school canteen practices consistent with a healthy canteen policy of the New South Wales ( NSW ) , Australia , government known as the ` Fresh Tastes @ School NSW Healthy School Canteen Strategy ' .", "The parallel randomised trial will be conducted in 70 primary schools located in the Hunter region of New South Wales , Australia .", "Schools will be eligible to participate if they are not currently meeting key components of the healthy canteen policy .", "Schools will be randomly allocated after baseline data collection in a 1:1 ratio to either an intervention or control group using a computerised random number function in Microsoft Excel .", "Thirty-five schools will be selected to receive a multi-component intervention including implementation support from research staff , staff training , resources , recognition and incentives , consensus and leadership strategies , follow-up support and implementation feedback .", "The 35 schools allocated to the control group will not receive any intervention support as part of the research trial .", "The primary outcome measures will be i ) the proportion of schools with a canteen menu that does not contain foods or beverages restricted from regular sale ( ` red ' and ` banned ' items ) and ii ) the proportion of schools where healthy canteen items ( ` green ' items ) represent the majority ( > 50 % ) of products listed on the menu .", "Outcome data will be collected via a comprehensive menu audit , conducted by dietitians blind to group allocation .", "Intervention effectiveness will be assessed using logistic regression models adjusting for baseline values .", "The proposed trial will represent a novel contribution to the literature , being the first randomised trial internationally to examine the effectiveness of an intervention to facilitate implementation of a healthy canteen policy .", "Australian New Zealand Clinical Trials Registry ACTRN12613000311752 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "Adherence to the Mediterranean diet ( MD ) is associated with reduced morbidity and mortality due to cardiovascular disease .", "However , how the MD exerts its effects is not fully known .", "To assess the 12-month effects of two enhanced MDs compared to a low-fat diet on inflammatory biomarkers related to atherosclerosis and plaque vulnerability in a subcohort of the PREDIMED ( Prevencin con Dieta Mediterrnea ) study .", "A total of 164 participants at high risk for cardiovascular disease were randomized into three diet groups : MD supplemented with 50mL/d of extra virgin olive oil ( MD+EVOO ) or 30 g/d of nuts ( MD+N uts ) and a low-fat diet .", "Changes in classical cardiovascular risk factors , inflammatory biomarkers of atherosclerosis and plaque vulnerability were measured after 12 months of intervention .", "Compared to participants in the low-fat diet group , those receiving MD+EVOO and MD+N uts showed a higher decrease in systolic ( 6mmHg ) and diastolic ( 3mmHg ) blood pressure ( P = 0.02 ; both ) , as well as a reduction of 10 % and 8 % in LDL-cholesterol ( P = 0.04 ) , respectively .", "Patients in the MD+N uts group showed a significant reduction of 34 % in CD40 expression on monocyte surface compared to low-fat diet patients ( P = 0.03 ) .", "In addition , inflammatory biomarkers related to plaque instability such as C-reactive protein and interleukin-6 were reduced by 45 % and 35 % and 95 % and 90 % in the MD+EVOO and MD+N uts groups , respectively ( P < 0.05 ; all ) compared to the low-fat diet group .", "Likewise , sICAM and P-selectin were also reduced by 50 % and 27 % , respectively in the MD+EVOO group ( P = 0.04 ) and P-selectin by 19 % in MD+N uts group ( P = 0.04 ) compared to the low-fat diet group .", "Adherence to the MD is associated with an increase in serum markers of atheroma plaque stability which may explain , at least in part , the protective role of MD against ischemic heart disease .", "www.controlled-trials.com ISRCTN35739639 ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "External cephalic version ( ECV ) is offered to reduce the number of Caesarean delivery indicated by breech presentation which occurs in 3-4 % of term pregnancies .", "ECV is commonly performed aided by the application of aqueous gel or talcum powder to the maternal abdomen .", "We sought to compare gel with powder during ECV on achieving successful version and increasing tolerability .", "We enrolled 95 women ( 36 weeks gestation ) on their attendance for planned ECV .", "All participants received terbutaline tocolysis .", "Regional anaesthesia was not used .", "ECV was performed in the standard fashion after the application of the allocated aid .", "If the first round ( maximum of 2 attempts ) of ECV failed , crossover to the opposing aid was permitted .", "48 women were randomised to powder and 47 to gel .", "Self-reported procedure related median [ interquartile range ] pain scores ( using a 10-point visual numerical rating scale VNRS ; low score more pain ) were 6 [ 5-9 ] vs. 8 [ 7-9 ] P = 0.03 in favor of gel .", "ECV was successful in 21/48 ( 43.8 % ) vs. 26/47 ( 55.3 % ) RR 0.6 95 % CI 0.3-1 .4 P = 0.3 for powder and gel arms respectively .", "Crossover to the opposing aid and a second round of ECV was performed in 13/27 ( 48.1 % ) following initial failure with powder and 4/21 ( 19 % ) after failure with gel ( RR 3.9 95 % CI 1.0-15 P = 0.07 ) .", "ECV success rate was 5/13 ( 38.5 % ) vs. 1/4 ( 25 % ) P = 0.99 after crossover use of gel or powder respectively .", "Operators reported higher satisfaction score with the use of gel ( high score , greater satisfaction ) VNRS scores 6 [ 4.25-8 ] vs 8 [ 7-9 ] P = 0.01 .", "Women find gel use to be associated with less pain .", "The ECV success rate is not significantly different .", "The trial is registered with ISRCTN ( identifier ISRCTN87231556 ) ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Effective patient/provider communication is important to ensure patient understanding , safety , and satisfaction .", "Our hypothesis was that interactive patient/provider counseling using a web-based tool ( iPad application ) would have a greater impact on patient satisfaction with understanding prolapse symptoms compared with standard counseling ( SC ) .", "Women with complaints of seeing/sensing a vaginal bulge were enrolled in this randomized controlled trial .", "Participants completed pre - and postvisit Likert scale questionnaires on satisfaction with prolapse knowledge and related anxiety .", "After new patient histories and physical examinations , study participants were randomized to SC or SC with iPad .", "Ninety participants were required to detect a 30 % difference in satisfaction with prolapse knowledge between the two groups .", "Ninety women were randomized to SC ( n = 44 ) or SC with iPad ( n = 46 ) .", "At baseline , 47 % of women were satisfied with their understanding of bulge symptoms ( 50 % SC vs. 43.5 % SC with iPad , p = 0.5 ) .", "After counseling , 97 % of women reported increased satisfaction with understanding of bulge symptoms ( p < 0.0001 ) , with no difference between groups [ 42/44 ( 95.5 % ) SC vs. 45/46 ( 97.8 % ) SC with iPad , p = 0.5 ] .", "Baseline anxiety was high : 70 % ( 65.9 % SC vs. 73.9 % SC with iPad , p = 0.4 ) .", "After counseling , anxiety decreased to 30 % ( p < 0.0001 ) , with improvement in both groups ( 31.8 % SC vs. 28.3 % SC with iPad , p = 0.7 ) .", "Counseling times were similar between groups ( 9.5 min. , SC vs. 8.9 min. , SC with iPad , p = 0.4 ) .", "Interactive counseling was associated with increased patient satisfaction with understanding bulge symptoms and decreased anxiety whether a web-based tool was used or not ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Guidelines for management of hypertension and lipids recommend using cardiovascular absolute risk ( CVAR ) to manage patients .", "This randomized controlled trial investigated the impact of CVAR assessment in family practice on management of cardiovascular risk , including prescription of antihypertensive and lipid-lowering medication .", "A cluster randomized controlled trial was conducted from 2008 to 2010 in Sydney , Australia .", "Family practices were randomized , and patients aged 45 to 69 years were invited to participate .", "Intervention family physicians ( FP ) were trained in use of CVAR , provided with an electronic CVAR calculator , and assessed their patients ' absolute risk in a dedicated consultation .", "Control practice patients received a general health check .", "Primary outcome analyzed was the proportion of patients in each group on antihypertensive and/or lipid-lowering medication at 12 months .", "Multilevel logistic regression was performed to explore variables influencing changes in pharmacologic therapy .", "The study recruited 36 FPs from 34 practices and 1,074 patients , of which 906 ( 84.4 % ) completed 12-month follow-up .", "At 12 months , there was no significant difference between the intervention and control groups in proportion of patients on antihypertensives ( 31.2 % vs 34.3 % , P = .31 ) , but control group patients were more likely to be on lipid-lowering medications ( 30.2 % vs 22.7 % , P = .01 ) .", "After multilevel analysis , this difference was not present .", "Intensification or reduction of pharmacologic therapy was associated with meeting treatment targets for blood pressure and lipids but not with the CVAR or intervention group .", "Single-risk factor management remains a strong influence on FP prescribing practices .", "Shifting to an approach based on CVAR will require more intensive intervention ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Chronic obstructive pulmonary disease ( COPD ) is characterized by irreversible airflow limitation and is associated with weight loss and decreased muscle strength and exercise capacity .", "A double-blinded randomized controlled trial of 32 male COPD patients ( age , 54.94 11.27 years ) was carried out to assess effects of anabolic steroid in terms of a daily high-protein , high-calorie diet alone or one combined with anabolic steroids on body composition , lung function , and health-related quality of life ( HRQL ) .", "Outcomes were assessed by anthropometric and spirometric measurements , peak expiratory flow rate , partial pressure of oxygen in arterial blood , 6-minute walk test ( 6MWT ) , hand grip test , and HRQL index scores .", "Measurements were made at baseline and end of treatment ( 6 weeks ) .", "All patients showed significant difference ( P < .001 ) in pulmonary function parameters and anthropometric measurements after 6 weeks of intervention ( within-group changes ) ; however , no significant improvement occurred in the pulmonary function parameters between the groups .", "The difference in exercise capacity ( 6MWT ) and HRQL scores in the treatment group were statistically significant ( P < .001 ) compared with control group after 6 weeks of intervention .", "In the treatment group , the average 6MWT distance increased from 213.5 m to 268.5 m at 6-week follow-up , and HRQL scores increased from 101.25 to 118.45 .", "Also , HRQL and 6MWT parameters were positively correlated in response to steroid supplementation at the end of the study .", "Weekly administration of anabolic steroids during 6 weeks increased exercise capacity and quality of life in patients with COPD ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Implantable cardioverter defibrillator ( ICD ) remote follow-up and ICD remote monitoring ( RM ) are established means of ICD follow-up .", "The reduction of the number of in-office visits and the time to decision is proven , but the true clinical benefit is still unknown .", "Cost and cost-effectiveness of RM remain leading issues for its dissemination .", "The MONITOR-ICD study has been designed to assess costs , cost-effectiveness , and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial .", "Patients indicated for single - or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD ( Lumax VR-T or Lumax DR-T ; Biotronik SE & Co KG , Berlin , Germany ) .", "Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol .", "As of December 2011 , recruitment has been completed , and 416 patients have been enrolled .", "Subjects are followed-up for a minimum of 12months and a maximum of 24months , ending in January 2013 .", "Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups .", "Secondary end points include ICD shocks ( including appropriate and inappropriate shocks ) , cardiovascular hospitalizations and cardiovascular mortality , and additional health economic end points .", "The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014 .", "Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This study aims to assess the effects of proanthocyanidin-a class of polyphenol antioxidants extracted from grape seeds-on menopausal symptoms , body composition , and cardiovascular parameters in middle-aged women .", "We conducted a randomized , double-blind , placebo-controlled study in 96 women aged 40 to 60 years who had at least one menopausal symptom .", "The study participants were randomized to receive grape seed extract tablets containing either low-dose ( 100 mg/d ) or high-dose ( 200 mg/d ) proanthocyanidin , or placebo , for 8 weeks .", "Their menopausal symptoms were evaluated using the Menopausal Health-Related Quality of Life Questionnaire , Hospital Anxiety and Depression Scale , and Athens Insomnia Scale before and after 4 and 8 weeks of treatment .", "Body composition and cardiovascular parameters were also measured .", "A total of 91 women ( 95 % ) completed the study .", "Background characteristics , including age , menopause status , subjective symptom scores , body composition , and cardiovascular parameters , were similar among the groups .", "The following significant changes were observed during the course of the study : ( 1 ) physical symptom score , hot flash score , and ( 2 ) Athens Insomnia Scale score decreased in the high-dose group after 8 weeks of treatment ; ( 3 ) Hospital Anxiety and Depression Scale Anxiety score and ( 4 ) systolic and diastolic blood pressure decreased in the low-dose and high-dose groups after 4 weeks ; and , ( 5 ) lastly , muscle mass increased in the low-dose and high-dose groups after 8 weeks of treatment .", "Grape seed proanthocyanidin extract is effective in improving the physical and psychological symptoms of menopause while increasing muscle mass and reducing blood pressure in middle-aged women ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Medications for the treatment of substance use disorders ( SUDs ) are not widely available in publicly funded SUD treatment programs .", "Few studies have drawn on longitudinal data to examine the organizational characteristics associated with programs transitioning from not delivering any pharmacotherapy to adopting at least one SUD medication .", "Using two waves of panel longitudinal data collected over a 5-year period , we measured the transition to medication adoption in a cohort of 190 publicly funded treatment organizations that offered no SUD medications at baseline .", "Independent variables included organizational characteristics , medical resources , funding , treatment culture , and detailing activities by pharmaceutical companies .", "Of 190 programs not offering SUD pharmacotherapy at baseline , 22.6 % transitioned to offering at least one SUD medication at follow-up approximately 5 years later .", "Multivariate logistic regression results indicated that the employment of at least one physician at baseline , having a greater proportion of Medicaid clients , and pharmaceutical detailing were positively associated with medication adoption .", "Adoption of pharmacotherapy was more likely in programs that had greater medical resources , Medicaid funding , and contact with pharmaceutical companies .", "Given the potential expansion of Medicaid under the Affordable Care Act , patients served by publicly funded programs may gain greater access to such treatments , but research is needed to document health reform 's impact on this sector of the treatment system ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The relationship between alcohol use and risky sexual behavior is complex and depends on psychological and environmental factors .", "The alcohol myopia model predicts that , due to alcohol 's impact on attention , the behavior of intoxicated individuals will become increasingly directed by salient cues .", "Autonomic arousal ( AA ) may have a similar effect on attention .", "Experiential delay discounting ( DD ) may be increased by both alcohol consumption and AA due to their common effects and may mediate the relationship between these conditions and risky sex .", "This study employed a 3 ( alcohol , placebo , control ) 2 ( high , low arousal ) experimental design to examine the effects of acute alcohol intoxication and AA on experiential delay discounting , subjective sexual arousal , and risky sex .", "Path models revealed complex results that only partially supported study hypotheses .", "Ratings of subjective sexual arousal did not differ across either beverage or arousal conditions .", "DD was also unrelated to any study variable .", "However , subjective sexual arousal was positively related to risky sexual intentions .", "Alcohol intoxication was also positively associated with increased unprotected sex intentions , consistent with past studies .", "These results affirm the role of subjective sexual arousal and alcohol intoxication in risky sexual decision-making , yielding effect sizes similar to comparable past studies .", "The lack of differences across autonomic arousal groups also suggests that effects of attentional myopia may be behavior-specific .", "Failure to replicate effects of alcohol intoxication on DD also suggests reservation regarding its involvement in alcohol-involved risky sex ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This study was designed to evaluate the response and toxicity of sorafenib alone or when combined with carboplatin and paclitaxel in patients with platinum-sensitive , recurrent ovarian cancer , fallopian tube cancer , or primary peritoneal cancer ( EOC ) .", "Patients with recurrent platinum-sensitive EOC with no more than 2 prior courses of chemotherapy were randomized to single-agent sorafenib 400 mg twice daily or combination sorafenib 400 mg bid ( days 2-19 ) with IV carboplatin ( AUC 6 ) and IV paclitaxel 175 mg/m ( 2 ) ( S+C / T ) every 3 weeks .", "Single agent sorafenib could cross over to combination upon progression .", "Patients were initially randomized to either arm , however , due to poor accrual , sorafenib arm was prematurely closed .", "A total of 13 patients were evaluable for response to sorafenib and 23 patients were evaluable for response to S+C / T. Objective response rate ( RR ) was 15 % for patients on sorafenib vs. 61 % for patients on S+C / T ( p = 0.014 ) ; stable disease was seen in 62 % and 35 % , respectively .", "Clinical benefit rate ( CBR ) at 4 months ( mos . )", "was 69 % for S and 65 % for S+C / T.", "The median progression free survival was 5.6 months on sorafenib vs. 16.8 months on S+C / T ( p = 0.012 ) and there was no significant difference of overall survival between two arms ( p = 0.974 ) with median overall survival 25.6 months under sorafenib vs. 25.9 months on S+C / T. Patients remained on trial for a median of 7.8 cycles on sorafenib and 5.4 cycles on S+C / T.", "Sorafenib , alone or in combination with carboplatin and paclitaxel , has activity in patients with platinum-sensitive EOC .", "Sorafenib in combination with carboplatin and paclitaxel improved RR and PFS ; however , there were increased grade and frequencies of toxicities ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The aim of this study was to evaluate the safety , pharmacokinetics , and clinical response of brodalumab ( AMG 827 ) , a human , anti-IL-17 receptor A ( IL-17RA ) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis ( RA ) .", "This phase Ib , randomized , placebo-controlled , double-blind multiple ascending dose study enrolled subjects with moderate to severe RA ( 6/66 swollen and 8/68 tender joints ) .", "Subjects were randomized 3:1 to receive brodalumab ( 50 mg , 140 mg , or 210 mg subcutaneously every two weeks for 6 doses per group ; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group ) or placebo .", "Endpoints included incidence of adverse events ( AEs ) and pharmacokinetics .", "Exploratory endpoints included pharmacodynamics , and improvements in RA clinical metrics .", "Forty subjects were randomized to investigational product ; one subject discontinued due to worsening of RA ( placebo ) .", "The study was not designed to assess efficacy .", "AEs were reported by 70 % ( 7/10 ) of placebo subjects and 77 % ( 22/30 ) of brodalumab subjects .", "Three serious AEs were reported in two subjects ; there were no opportunistic infections .", "Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes .", "No treatment effects were observed with individual measures of RA disease activity .", "On day 85 ( week 13 ) 37 % ( 11/30 ) of brodalumab subjects and 22 % ( 2/9 ) of placebo subjects achieved ACR20 ; 7 % ( 2/30 ) brodalumab subjects and 11 % ( 1/9 ) of placebo subjects achieved ACR50 ; and 0 % ( 0/30 ) brodalumab subjects and 0 % ( 0/9 ) of placebo subjects achieved ACR70 .", "Multiple dose administration of brodalumab was tolerated in subjects with active RA .", "There was no evidence of a clinical response to brodalumab in subjects with RA .", "ClinicalTrials.gov , NCT00771030 ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer .", "Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10 ( 8 ) colony-forming units and 4.3 g of soluble fiber ( Nestl ) or placebo .", "The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment .", "The sum of both the complete ( proctitis symptoms plus quality of life ) and partial ( proctitis symptoms ) scores of the EORTC QLQ-PRT23 ( European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items ) questionnaire were the main endpoints .", "This pilot study showed that the complete questionnaire score ( median [ range ] ) was higher in the second ( 23 [ 21-30 ] vs 26.5 [ 22-34 ] , P < .05 ) and third ( 23 [ 21-32 ] vs 27.5 [ 24-33 ] , P < .01 ) weeks in the placebo group .", "Proctitis symptoms were highest scored in the placebo group in both the second ( 19.5 [ 16-25 ] ) and third ( 19 [ 17-24 ] ) weeks than in the synbiotic group ( week 2 : 16.5 [ 15-20 ] , P < .05 ; week 3 : 17 [ 15-23 ] , P < .01 ) .", "In both scores the placebo group had a significantly higher result ( P < .01 ) than the synbiotic group ( repeated-measures analysis of variance ) .", "Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To evaluate the safety of two commercially available formulations of bimatoprost eye drops : 0.03 and 0.01 % ophthalmic solutions .", "This was a randomized , prospective , parallel-group , open-label , cohort study .", "A total of 60 glaucoma patients ( 60 eyes ) under bimatoprost 0.03 % monotherapy since at least 1 year were enrolled .", "Selected patients were randomized to receive a single drop of bimatoprost 0.01 % ( n = 30 ) or bimatoprost 0.03 % ( n = 30 ) ophthalmic solutions for 12 months .", "Statistical analysis was performed using paired t-test and repeated measures ANOVA test .", "Global clinical score ( the sum of pruritus , stinging/burning , blurred vision , sticky eye sensation , eye dryness sensation , and foreign body sensation ) significantly decreased in the bimatoprost 0.01 % group from baseline 4.7 3.8 to 2.9 2.3 ( P < 0.001 ) and 2.5 2.0 ( P < 0.001 ) at 6-month and 12-month follow-ups , respectively .", "Comparison between groups showed differences at both follow-up visits ( P = 0.003 and P < 0.001 , respectively ) .", "In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01 % group compared with the bimatoprost 0.03 % group ( P < 0.001 at both follow-up visits ) .", "All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01 % group at each follow-up visit ( P < 0.05 ) and in comparison with bimatoprost 0.03 % ( P < 0.05 ) .", "The results of this trial suggest that bimatoprost 0.01 % eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03 % eye drops ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Type 1 diabetes mellitus ( T1DM ) is caused by insulin deficiency resulting from progressive destruction of cells .", "The histological hallmark of the diabetic islet is mononuclear cell infiltration .", "Thiazolidinediones ( TZDs ) activate PPARg and enhance the actions of insulin .", "Studies in non-obese diabetic and streptocotozin-treated mouse models demonstrated that pretreatment with TZDs prevented the development of T1DM .", "The purpose of this study was to examine whether pioglitazone , given with insulin , preserved cell function in patients with new-onset T1DM .", "This was a randomized , double-blind , placebo-controlled 24-week study .", "Subjects received pioglitazone or placebo .", "Blood sugar , glycated hemoglobin ( HbA1c ) , C-peptide , and liver enzymes were measured at baseline .", "Boost stimulated C-peptide responses were measured at baseline and at 24 weeks .", "Blood sugar , insulin dose , height , weight , and liver enzymes were monitored at each visit .", "HbA1c was performed every 12 weeks .", "Of the 15 patients , 8 received pioglitazone , and 7 - placebo .", "There was no clinical improvement in HbA1c between or within groups at the completion of the study .", "Mean peak C-peptide values were similar between groups at baseline .", "Mean peak C-peptide level was slightly higher at 24 weeks in the pioglitazone group compared to the placebo ( 1.8 vs. 1.5 ng/mL ) which was considered as clinically insignificant .", "The interaction of HbA1c and insulin dose ( HbA1c * insulin/kg/day ) , which combines degree of diabetic control and dose of insulin required to achieve this control , showed transient improvement in the pioglitazone group at 12 weeks but was not sustained at 24 weeks .", "In this pilot study , pioglitazone did not preserve cell function when compared to placebo ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]