Datasets:

radiachkik

/

PubMed_20k_RCT

like 0

[ "Investigate the 5-year longitudinal changes in bone curvature after acute anterior cruciate ligament ( ACL ) injury , and identify predictors of such changes .", "In the KANON-trial ( ISRCTN 84752559 ) , 111/121 young active adults with an acute ACL tear to a previously un-injured knee had serial 1.5 T MR images from baseline ( within 5 weeks from injury ) to 5 years after injury .", "Of these , 86 had ACL reconstruction ( ACLR ) performed early or delayed , 25 were treated with rehabilitation alone .", "Measures of articulating bone curvature were obtained from computer-assisted segmentation of MR images .", "Curvature ( mm ( -1 ) ) was determined for femur , tibia , medial/lateral femur , trochlea , medial/lateral tibia .", "Age , sex , treatment , BMI , meniscal injury , osteochondral fracture on baseline MR images were tested for association .", "Over 5 years , curvature decreased in each region ( P < 0.001 ) suggesting flattening of convex shapes and increased concavity of concave shapes .", "A higher BMI was associated with flattening of the femur ( P = 0.03 ) , trochlea ( P = 0.007 ) and increasing concavity of the lateral tibia ( LT ) ( P = 0.011 ) .", "ACLR , compared to rehabilitation alone , was associated with flatter curvature in the femur ( P < 0.001 ) , medial femoral condyle ( P = 0.006 ) and trochlea ( P = 0.003 ) .", "Any meniscal injury at baseline was associated with a more flattened curvature in the femur ( P = 0.038 ) , trochlea ( P = 0.039 ) , lateral femoral condyle ( P = 0.034 ) and increasing concavity of the LT ( P = 0.048 ) .", "ACL injury is associated with significant changes in articulating bone curvature over a 5 year period .", "Higher BMI , baseline meniscal injury and undergoing ACL reconstruction ( as distinct from undergoing rehabilitation alone ) are all associated with flattening of the articulating bone ." ]

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

[ "To test the effects of integrating health protection and health promotion with a continuous improvement system ( Kaizen ) on proximal employee outcomes ( health promotion , integration , and Kaizen ) and distal outcomes ( workability , productivity , self-rated health and self-rated sickness absence ) .", "Twelve units in a county hospital in Sweden were randomized to control or intervention groups using a quasiexperimental study design .", "All staff ( approximately 500 ) provided self-ratings in questionnaires at baseline , and a 12 - and 24-month follow-up ( response rate , 79 % to 87.5 % ) .", "There was a significant increase in the proximal outcomes over time in the intervention group compared with the control group , and a trend toward improvement in the distal outcomes workability and productivity .", "Integration seems to promote staff engagement in health protection and promotion , as well as to improve their understanding of the link between work and health ." ]

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

[ "Laparoscopy cholecystectomy for the surgical treatment of cholelithiasis has been considered the gold standard .", "The referred pain to the shoulder ( omalgia ) may be present to 63 % of the patients and limits outpatient management .", "The study was to evaluate the usefulness of acetazolamide associated with ketorolac for reduction of the omalgia to minimally invasive treatment .", "We performed a clinical trial , randomized , double blind in patients undergoing laparoscopic cholecystectomy to assess the reduction of post-operative omalgia comparing ketorolac and ketorolaco + acetazolamida .", "31 patients in each group were studied .", "The study group : 250 mg of acetazolamide before anesthetic induction and 30 mg of ketorolac in the immediate postoperative period .", "one tablet of placebo prior to the anesthetic induction and 30 mg of ketorolac in the immediate postoperative .", "The presence of omalgia was assessed using the analog visual scale .", "The variables recorded included : age , sex , flow of carbon dioxide intra-abdominal pressure , surgical time , urgent or elective surgery , omalgia , severity of pain evaluated by analog visual scale , addition analgesia .", "Both groups were homogeneous and statistical analysis showed no differences in the variables studied .", "The omalgia in the study group was presented at 9.67 % and in the group control was the 58.06 % ( p < 0.001 ) .", "250 mg oral acetazolamide associated 30 mg of ketorolac reduces significantly the development of omalgia in patients undergoing laparoscopic cholecystectomy ." ]

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

[ "Using a monoclonal antibody with greater affinity for IgE than omalizumab , we examined whether more complete suppression of IgE provided greater pharmacodynamic effects , including suppression of skin prick responses to allergen .", "To explore the pharmacokinetics , pharmacodynamics and safety of QGE031 ( ligelizumab ) , a novel high-affinity humanized monoclonal IgG1 anti-IgE .", "Preclinical assessments and two randomized , placebo-controlled , double-blind clinical trials were conducted in atopic subjects .", "The first trial administered single doses of QGE031 ( 0.1-10mg / kg ) or placebo intravenously , while the second trial administered two to four doses of QGE031 ( 0.2 - 4mg/kg ) or placebo subcutaneously at 2-week intervals .", "Both trials included an open-label omalizumab arm .", "Sixty of 73 ( 82 % ) and 96 of 110 ( 87 % ) subjects completed the intravenous and subcutaneous studies , respectively .", "Exposure to QGE031 and its half-life depended on the QGE031 dose and serum IgE level .", "QGE031 had a biexponential pharmacokinetic profile after intravenous administration and a terminal half-life of approximately 20days .", "QGE031 demonstrated dose - and time-dependent suppression of free IgE , basophil FcRI and basophil surface IgE superior in extent ( free IgE and surface IgE ) and duration to omalizumab .", "At Day 85 , 6weeks after the last dose , skin prick wheal responses to allergen were suppressed by > 95 % and 41 % in subjects treated subcutaneously with QGE031 ( 2mg/kg ) or omalizumab , respectively ( P < 0.001 ) .", "Urticaria was observed in QGE031 - and placebo-treated subjects and was accompanied by systemic symptoms in one subject treated with 10mg/kg intravenous QGE031 .", "There were no serious adverse events .", "These first clinical data for QGE031 , a high-affinity IgG1 anti-IgE , demonstrate that increased suppression of free IgE compared with omalizumab translated to superior pharmacodynamic effects in atopic subjects , including those with high IgE levels .", "QGE031 may therefore benefit patients unable to receive , or suboptimally treated with , omalizumab ." ]

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

[ "Hospitalization for worsening heart failure ( HF ) is known to increase mortality and morbidity risk and has been frequently used as an endpoint in randomized clinical trials .", "Whether outpatient management of HF exacerbation carries similar prognostic and therapeutic information is less well known , but could be important for the design of trials that use HF hospitalization as an endpoint .", "MADIT-CRT randomized patients with mild HF symptoms to resynchronization therapy vs. control with an average follow-up of 3.3 years and a total of 191 deaths .", "HF events were centrally adjudicated for receiving i.v. decongestive therapy in an outpatient setting , or an augmented HF regimen during a hospital stay .", "Patients were compared according to whether their first HF was an out - or inpatient event .", "The first primary event was non-fatal outpatient HF , non-fatal inpatient HF , and death in 52 , 331 , and 78 patients , respectively .", "Patients with inpatient HF tended to be older and more likely to have HF of ischaemic aetiology than subjects who developed outpatient HF events .", "The risk of death following either type of non-fatal HF events was extremely high [ hazard ratio ( HR ) 12.4 , 95 % confidence interval ( CI ) 9.1-16 .9 for inpatient HF ; HR 10.7 , 95 % CI 6.1-18 .7 for outpatient HF ] compared with subjects without non-fatal HF events .", "Allocation to CRT-D was associated with significant reduction in both types of HF .", "Outpatient management of worsening HF portends a high risk of death , similar to inpatient HF events , and may be equally sensitive to the effects of therapy .", "These findings suggest that outpatient HF events should be considered in publicly reported outcomes measures and future HF clinical trials .", "NCT01294449 ." ]

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

[ "To observe the effects of anesthetic intervention with small-dose lidocaine and ketamine on early postoperative cognitive function in elderly patients undergoing surgeries for gastrointestinal tumors .", "Sixty patients ( ASA I-III , aged 63-82 years ) scheduled for surgeries for gastrointestinal tumors were randomized into intervention group ( n = 30 ) and control group ( n = 30 ) .", "After intravenous induction and tracheal intubation , the patients in the interventional group received intravenous infusion of 0.5 mg/kg lidocaine and 0.5 mg/kg ketamine , followed by continuous infusion of lidocaine at the rate of 0.5 mgkg ( -1 ) h ( -1 ) till the end of the operation ; the patients in the control group received saline infusion only .", "The cognitive function of the patients was assessed at 3 day before and 2 day after the operation using comprehensive neuro-psychological tests .", "Peripheral venous blood was extracted before anesthesia induction ( T0 ) , at the end of the surgery ( T1 ) , and at 1 day ( T2 ) and 2 days ( T3 ) after the operation for measurement of serum S-100 protein , NSE and IL-6 levels using ELISA .", "The difference between the test scores before and after the operation ( X values ) was significantly smaller in the intervention group than in the control group ( P < 0.05 ) .", "The intervention group showed a significantly lower incidence rate of postoperative cognitive dysfunction ( POCD ) than the control group ( 6.7 % vs 33.3 % , P < 0.05 ) .", "Compared with the control group , the intervention group exhibited significantly lower serum levels of S-100 protein , NSE and IL-6 at T1 ( P < 0.05 ) , significantly lower NSE and IL-6 levels at T2 ( P < 0.05 ) time point , and significantly lower IL-6 level at T3 ( P < 0.05 ) .", "Intravenous injection of small-dose lidocaine and ketamine during the operation can reduce the incidence of POCD in elderly patients undergoing surgeries for gastrointestinal tumors possibly in relation to decreased serum S-100 , NSE and IL-6 levels ." ]

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

[ "The impact of interferon beta ( IFN ) therapy on a patient 's quality of life ( QoL ) has not been completely clarified .", "This multicenter , independent , observational and longitudinal study was aimed to evaluate the impact of different pharmaceutical formulations of IFN-1a on QoL in patients affected by relapsing-remitting multiple sclerosis ( RRMS ) .", "The multiple sclerosis quality of life-54 questionnaire was used to assess patients ' QoL .", "394 ( 66 % ) patients completed the two-year study ; 152 were treated with IFN-1a i.m. weekly injected ( group a ) , 152 with IFN-1a 44 g s.c. injected three times a week ( group b ) and 90 were untreated ( group c ) .", "After two years , a significant increase was found in the physical health composite score ( = +3.1 in group a , = +3 in group b , p < 0.05 in both ) , mental health composite score ( = +4.7 in group a , = +5.5 in group b , p < 0.001 in both ) , in eight MSQoL sub-items of group a and in seven sub-items in group b. Conversely , the untreated group showed a slight decrease in seven domains .", "The variable `` therapy with DMDs '' was associated with improved QoL .", "QoL of RRMS could be improved by IFN-1a treatment , despite natural history data which seem to demonstrate that QoL could get worse over the time ." ]

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

[ "Physical activity is believed to exert a beneficial effect on functional and cognitive rehabilitation of patients with stroke .", "Although studies have addressed the impact of physical exercise in cerebrovascular prevention and rehabilitation , the underlying mechanisms leading to improvement are poorly understood .", "Training-induced increase of cerebral perfusion is a possible mediating mechanism .", "Our exploratory study aims to investigate training-induced changes in blood biomarker levels and magnetic resonance imaging in patients with subacute ischemic stroke .", "This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized , controlled PHYS-STROKE trial .", "In PHYS-STROKE , 215 patients with subacute stroke ( hemorrhagic and ischemic ) receive either 4weeks of physical training ( aerobic training , 5 times a week , for 50minutes ) or 4weeks of relaxation sessions ( 5 times a week , for 50minutes ) .", "A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging ( MRI ) scans and an additional blood draw before and after the PHYS-STROKE intervention .", "Imaging scans will address parameters of cerebral perfusion , vessel size imaging , and microvessel density ( the Q factor ) to estimate the degree of neovascularization in the brain .", "Blood tests will determine several parameters of immunity , inflammation , endothelial function , and lipometabolism .", "Primary objective of this study is to evaluate differential changes in MRI and blood-derived biomarkers between groups .", "Other endpoints are next cerebrovascular events and functional status of the patient after the intervention and after 3months assessed by functional scores , in particular walking speed and Barthel index ( co-primary endpoints of PHYS-STROKE ) .", "Additionally , we will assess the association between functional outcomes and biomarkers including imaging results .", "For all endpoints we will compare changes between patients who received physical fitness training and patients who had relaxation sessions .", "This exploratory study will be the first to investigate the effects of physical fitness training in patients with ischemic stroke on MRI-based cerebral perfusion , pertinent blood biomarker levels , and functional outcome .", "The study may have an impact on current patient rehabilitation strategies and reveal important information about the roles of MRI and blood-derived biomarkers in ischemic stroke .", "NCT01954797 ." ]

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

[ "We previously reported decreased transfusions and donor exposures in preterm infants randomized to Darbepoetin ( Darbe ) or erythropoietin ( Epo ) compared with placebo .", "As these erythropoiesis-stimulating agents ( ESAs ) have shown promise as neuroprotective agents , we hypothesized improved neurodevelopmental outcomes at 18 to 22 months among infants randomized to receive ESAs .", "We performed a randomized , masked , multicenter study comparing Darbe ( 10 g/kg , 1/week subcutaneously ) , Epo ( 400 U/kg , 3/week subcutaneously ) , and placebo ( sham dosing 3/week ) given through 35 weeks ' postconceptual age , with transfusions administered according to a standardized protocol .", "Surviving infants were evaluated at 18 to 22 months ' corrected age using the Bayley Scales of Infant Development III .", "The primary outcome was composite cognitive score .", "Assessments of object permanence , anthropometrics , cerebral palsy , vision , and hearing were performed .", "Of the original 102 infants ( 946 196 g , 27.7 1.8 weeks ' gestation ) , 80 ( 29 Epo , 27 Darbe , 24 placebo ) returned for follow-up .", "The 3 groups were comparable for age at testing , birth weight , and gestational age .", "After adjustment for gender , analysis of covariance revealed significantly higher cognitive scores among Darbe ( 96.2 7.3 ; mean SD ) and Epo recipients ( 97.9 14.3 ) compared with placebo recipients ( 88.7 13.5 ; P = .01 vs ESA recipients ) as was object permanence ( P = .05 ) .", "No ESA recipients had cerebral palsy , compared with 5 in the placebo group ( P < .001 ) .", "No differences among groups were found in visual or hearing impairment .", "Infants randomized to receive ESAs had better cognitive outcomes , compared with placebo recipients , at 18 to 22 months .", "Darbe and Epo may prove beneficial in improving long-term cognitive outcomes of preterm infants ." ]

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

[ "Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children 's fruit and vegetable intake .", "This is the first cluster randomised controlled trial ( RCT ) designed to evaluate whether a school gardening programme can have an effect on children 's fruit and vegetable intake .", "The trial included children from 23 schools ; these schools were randomised into two groups , one to receive the Royal Horticultural Society ( RHS ) - led intervention and the other to receive the less involved Teacher-led intervention .", "A 24-hour food diary ( CADET ) was used to collect baseline and follow-up dietary intake 18months apart .", "Questionnaires were also administered to evaluate the intervention implementation .", "A total of 641 children completed the trial with a mean age of 8.1 years ( 95 % CI : 8.0 , 8.4 ) .", "The unadjusted results from multilevel regression analysis revealed that for combined daily fruit and vegetable intake the Teacher-led group had a higher daily mean change of 8g ( 95 % CI : -19 , 36 ) compared to the RHS-led group -32 g ( 95 % CI : -60 , -3 ) .", "However , after adjusting for possible confounders this difference was not significant ( intervention effect : -40 g , 95 % CI : -88 , 1 ; p = 0.06 ) .", "The adjusted analysis of process measures identified that if schools improved their gardening score by 3 levels ( a measure of school gardening involvement - the scale has 6 levels from 0 ` no garden ' to 5 ` community involvement ' ) , irrespective of group allocation , children had , on average , a daily increase of 81g of fruit and vegetable intake ( 95 % CI : 0 , 163 ; p = 0.05 ) compared to schools that had no change in gardening score .", "This study is the first cluster randomised controlled trial designed to evaluate a school gardening intervention .", "The results have found very little evidence to support the claims that school gardening alone can improve children 's daily fruit and vegetable intake .", "However , when a gardening intervention is implemented at a high level within the school it may improve children 's daily fruit and vegetable intake by a portion .", "Improving children 's fruit and vegetable intake remains a challenging task .", "ISRCTN11396528 ." ]

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

[ "Epidermal growth factor receptor tyrosine kinase inhibitors are effective as first-line therapy for advanced non-small cell lung cancer patients harboring epidermal growth factor receptor mutations .", "However , it is unknown whether second-line platinum-based chemotherapy after epidermal growth factor receptor tyrosine kinase inhibitor therapy could lead to better outcomes .", "We evaluated the efficacy of second-line platinum-based chemotherapy after gefitinib for advanced non-small cell lung cancers harboring epidermal growth factor receptor mutations ( the NEJ002 study ) .", "Seventy-one non-small cell lung cancers , treated with gefitinib as first-line therapy and then receiving platinum-based chemotherapy as second-line therapy were evaluated in NEJ002 .", "Patients were evaluated for antitumor response to second-line chemotherapy by computed tomography according to the criteria of the Response Evaluation Criteria in Solid Tumors group ( version 1.0 ) .", "Of the 71 patients receiving platinum-based chemotherapy after first-line gefitinib , a partial response was documented in 25.4 % ( 18/71 ) , stable disease in 43.7 % ( 31/71 ) and progression of disease in 21.1 % ( 15/71 ) .", "The objective response and disease control rates were 25.4 % ( 18/71 ) and 69 % ( 49/71 ) , respectively .", "There was no significant difference between first - and second-line chemotherapy in objective response and disease control rates for advanced non-small cell lung cancer harboring activating epidermal growth factor receptor mutations .", "In the analysis of epidermal growth factor receptor mutation types , the objective responses of deletions in exon 19 and a point mutation in exon 21 ( L858R ) were 27.3 % ( 9/33 ) and 28.1 % ( 9/32 ) , respectively , but these differences between objective response rates were not significant .", "The efficacy of second-line platinum-based chemotherapy followed at progression by gefitinib was similar to first-line platinum-based chemotherapy , and epidermal growth factor receptor mutation types did not influence the efficacy of second-line platinum-based chemotherapy ." ]

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

[ "This study aims to compare histopathological results of conventional surgery and transoral radiofrequency ablation in patients with early stage laryngeal carcinoma .", "Between January 2006 and May 2010 , 36 patients ( 34 males , 2 females ; mean age 61.6 years ; range 43 to 77 years ) who underwent partial laryngectomy in our clinic were retrospectively analyzed .", "All patients were randomized to partial laryngectomy with radiofrequency ablation or conventional surgery .", "Hoarseness due to early stage T1 and selected T2N0 vocal cord lesions was an indication for surgery .", "Of 20 patients receiving conventional surgery , 14 underwent partial laryngectomy , while six patients underwent cordectomy for the excision of tumors .", "Tumors were excised by transoral radiofrequency ablation in 16 patients .", "We observed thermal artifacts in four patients undergoing conventional surgery and in 13 patients undergoing transoral radiofrequency ablation .", "There was also hemorrhage in 16 patients undergoing conventional surgery and in seven patients undergoing transoral radiofrequency ablation .", "Histopathological examination revealed that the surgical margins were safe in 10 patients after radiofrequency ablation .", "The specimens obtained from six patients showed thermal artifacts which complicated histopathological examination .", "Sixteen ( 80 % ) of 20 conventional surgery patients and nine ( 56 % ) of 16 radiofrequency ablation patients had safe surgical margins .", "In radiofrequency ablation , the surgical zone must be larger than in conventional surgery due to the high risk of tissue damage and complicated histopathological examination ." ]

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

[ "Serum vascular endothelial growth factor-C ( VEGF-C ) , transforming growth factor - ( TGF - ) , and interleukin ( IL ) -6 promote angiogenesis and metastases in colon cancer .", "We hypothesized that patients who received propofol-epidural anaesthesia ( PEA ) would exhibit decreases in VEGF-C , TGF - , and IL-6 and an increase in IL-10 compared with patients who received general anaesthesia ( GA ) .", "Colon cancer surgery patients were randomly assigned to the PEA ( n = 20 ) or GA ( n = 20 ) group .", "Serum VEGF-C , TGF - , IL-6 , and IL-10 levels before surgery and 24 h after surgery were measured .", "Patients who received PEA showed decreases in VEGF-C [ 526 ( 261 ) vs 834 ( 304 ) pg ml ( -1 ) , P = 0.001 ] , TGF - ( P = 0.027 ) , and IL-6 ( P = 0.007 ) and an increase in IL-10 ( P = 0.001 ) 24 h after surgery compared with patients subjected to GA. .", "The visual analogue scale scores at rest and during coughing at 2 and 24 h after operation were significantly lower in PEA patients ( P < 0.05 ) .", "PEA reduces serum concentrations of factors associated with angiogenesis during colon cancer surgery .", "ChiCTR-TRC-13003146 ( www.chictr.org ) ." ]

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

[ "Cytomegalovirus ( CMV ) infection is a leading cause of illness and death in patients who have undergone allogeneic hematopoietic-cell transplantation .", "Available treatments are restricted by clinically significant toxic effects and drug resistance .", "In this phase 2 study , we evaluated the effect of letermovir ( also known as AIC246 ) , a new anti-CMV drug with a novel mechanism of action , on the incidence and time to onset of prophylaxis failure in CMV-seropositive recipients of allogeneic hematopoietic-cell transplants from matched related or unrelated donors .", "From March 2010 through October 2011 , we randomly assigned 131 transplant recipients in a 3:1 ratio to three sequential study cohorts according to a double-blind design .", "Patients received oral letermovir ( at a dose of 60 , 120 , or 240 mg per day , or matching placebo ) for 12 weeks after engraftment .", "The primary end point was all-cause prophylaxis failure , defined as discontinuation of the study drug because of CMV antigen or DNA detection , end-organ disease , or any other cause .", "Patients underwent weekly surveillance for CMV infection .", "The reduction in the incidence of all-cause prophylaxis failure was dose-dependent .", "The incidence of prophylaxis failure with letermovir , as compared with placebo , was 48 % versus 64 % at a daily letermovir dose of 60 mg ( P = 0.32 ) , 32 % at a dose of 120 mg ( P = 0.01 ) , and 29 % at a dose of 240 mg ( P = 0.007 ) .", "Kaplan-Meier time-to-onset profiles for prophylaxis failure showed a significant difference in the comparison of letermovir at a dose of 240 mg per day with placebo ( P = 0.002 ) .", "The safety profile of letermovir was similar to placebo , with no indication of hematologic toxicity or nephrotoxicity .", "Letermovir , as compared with placebo , was effective in reducing the incidence of CMV infection in recipients of allogeneic hematopoietic-cell transplants .", "The highest dose ( 240 mg per day ) had the greatest anti-CMV activity , with an acceptable safety profile .", "( Funded by AiCuris ; ClinicalTrials.gov number , NCT01063829 . )" ]

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

[ "Bleeding from peptic ulcers can be effectively and safely treated with endoscopic hemoclips therapy .", "However , due to certain limiting factors of hemoclips , application of combination with another endoscopic method may give better results .", "The aim of this study was to examine the efficacy and safety of endoscopic hemoclips therapy and to evaluate potential benefits of this therapy combined with epinephrine in the treatment of bleeding peptic ulcers .", "This prospective randomized study included 70 patients with bleeding gastric or duodenal ulcer .", "In 34 of the patients endoscopic hemoclips therapy was applied ( group I ) , and in 36 of them a combined therapy of hemoclips and epinephrine ( group II ) .", "Initial hemostasis was achieved in most patients treated with endoscopic hemoclips therapy ( 94.1 % ) as well as in the patients treated with combination therapy ( 97.2 % ) .", "After initial hemostasis achieved rebleeding occurred in 3 ( 9.3 % ) patients treated with hemoclips and in 2 ( 5.7 % ) patients treated with combination therapy , but this difference was not statistically significant ( p > 0.05 ) .", "The difference in the achieved final hemostasis between the group I ( 91.1 % ) and the group II ( 94.4 % ) was not statistically significant .", "Also , the differences between the two groups of patients in the need for blood transfusions , length of hospital stay , need for surgery and mortality were not statistically significant ( p > 0.05 ) .", "Endoscopic hemoclips therapy is effective and safe in treatment of bleeding peptic ulcers .", "Combination therapy of hemoclips and epinephrine has no advantage over hemoclips monotherapy ." ]

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

[ "To assess whether vaginal misoprostol or oral nonsteroidal anti-inflammatory drugs ( NSAIDs ) reduce pain during and 30 minutes after hysterosalpingography ( HSG ) .", "Randomized prospective , controlled , parallel-group study ( Canadian Task Force classification I ) .", "University teaching hospital .", "One hundred sixty-eight women with primary infertility who underwent HSG for evaluation of infertility .", "Patients were randomly assigned to 1 of 3 groups .", "Group 1 received 200 g misoprostol vaginally 6 hours before HSG ; group 2 , 50 mg diclofenac potassium orally 45 to 60 minutes before HSG ; and group 3 , no medication .", "The primary outcome of the study was to evaluate the severity of pain during and 30 minutes after the procedure using a visual analog scale ( VAS ) ranging from 1 ( very favorable ) to 10 ( very unfavorable ) .", "The secondary outcomes were to assess the rate of completion and the vasovagal effects including nausea , vomiting , sweating , weakness , syncope , hypotension , and bradycardia .", "There was no statistically significant difference in the median ( 25 % -75 % ) VAS pain scores between women administered vaginal misoprostol ( median , 6.7 cm ; range , 4.7-9 cm ) and the control group ( median , 6.7 cm ; range , 4.6-8 .8 cm ) during the HSG .", "However , women in the NSAID group ( median , 5.5 cm ; range , 3-7 .6 cm ) reported less pain than did those in the misoprostol group ( p = .009 ) and the control group ( p = .03 ) .", "At 30 minutes after HSG , there was no significant difference in the median VAS pain scores between patients administered NSAIDs ( median , 2.3 cm ; range , 1.4-4 .2 ) or misoprostol ( median , 2.3 cm ; range , 1.2-4 .4 ) and the control group ( median , 2.2 cm ; range , 1.3-4 .4 ) .", "There is no benefit in terms of pain reduction with the use of misoprostol during HSG or at 30 minutes after the procedure .", "However , NSAIDs are associated with pain relief during the HSG procedure ." ]

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

[ "Oral glucocorticoids can prevent acute mountain sickness ( AMS ) .", "Whether inhaled budesonide ( BUD ) can prevent AMS remains unknown .", "Our aim was to investigate the effectiveness of BUD in AMS prevention .", "Eighty subjects were randomly assigned to receive budesonide ( BUD , inhaled ) , procaterol tablet ( PT ) , budesonide/formoterol ( BUD/FM , inhaled ) , or placebo tablet ( n = 20 in each group ) .", "Subjects were treated for 3 days before ascending from 500 m to 3700 m within 2.5 h by air .", "Lake Louis AMS questionnaire , blood pressure , heart rate , and oxygen saturation ( SpO2 ) were examined at 20 , 72 , and 120 h after high-altitude exposure .", "Pulmonary function was measured at 20 h after exposure .", "Compared with placebo , BUD significantly reduced the incidence of AMS ( 70 % vs. 25 % at 20 h , p < 0.05 ; both 10 % vs. 5 % at 72 and 120 h , both p > 0.05 ) without side effects .", "The relative risk was 0.357 , and the risk difference was 0.45 .", "Mean SpO2 was higher in BUD , BUD/FM , and PT groups than in the placebo group at 20 h ( p < 0.05 ) .", "SpO2 in all 80 subjects dropped after ascent ( 98.1 % to 88.12 % , p < 0.01 ) and increased gradually , but it was still lower at 120 h than at baseline ( 92.04 % vs. 98.1 % , p < 0.01 ) .", "Pulmonary function did not differ among the four groups at 20 h.", "BUD can prevent AMS without side effects .", "The alleviation of AMS may be related to increased blood oxygen levels rather than pulmonary function ." ]

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

[ "The effects of supplementation of the omega-3 fatty acids eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) on prevalence and severity of depression were evaluated in patients after a myocardial infarction .", "A cross-sectional evaluation ( posttest-only design ) within the prospective , randomized , controlled , multicenter OMEGA trial was performed in patients after myocardial infarction at 12 months ' follow-up ( N = 2,081 ; age , mean = 64 years ; men , 76.7 % ; women , 21.8 % ) from April 2005 to June 2007 .", "Patients received supplementation with ethyl esters 90 ( 460-mg EPA and 380-mg DHA ) or placebo for 12 months .", "Depression was assessed with the Beck Depression Inventory-II ( BDI-II ) ; a BDI-II cutoff score of 14 was used as diagnosis of depression .", "When the total population was evaluated , no effects of EPA/DHA supplementation on depressive symptoms according to BDI-II score ( mean [ SD ] ) could be demonstrated : EPA/DHA ( n = 1,046 ) , 7.1 ( 6.9 ) ; placebo ( n = 1,035 ) , 7.1 ( 7.0 ) ; P = .7 .", "The post hoc analyses of depressed patients with and without antidepressants revealed a tendency toward an antidepressant effect in patients with EPA/DHA supplementation as monotherapy : EPA/DHA ( n = 125 ) , 19.4 ( 5.8 ) ; placebo ( n = 113 ) , 19.9 ( 5.1 ) ; P = .07 .", "However , in depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants , a clinically relevant antidepressant effect was demonstrated : EPA/DHA ( n = 33 ) , 20.9 ( 7.1 ) ; placebo ( n = 29 ) , 24.9 ( 8.5 ) ; P < .05 .", "EPA/DHA supplementation in the total sample of patients after myocardial infarction had no effect on depressive symptoms .", "The clinically relevant antidepressant effect in the subgroup of depressed patients with EPA/DHA supplementation as adjunctive to conventional antidepressants that was revealed in the post hoc analysis might provide a basis for a controlled , prospective trial of omega-3 augmentation of antidepressants in patients after myocardial infarction .", "ClinicalTrials.gov identifier : NCT00251134 ." ]

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

[ "This paper seeks to determine the relevance and likely salience of cognitive behaviour therapy ( CBT ) as a treatment for melancholic depression .", "The findings of a randomised trial comparing 12-week outcome of 18 patients with melancholic depression receiving antidepressant medication and 11 receiving CBT were evaluated , and qualitative explanations for the outcomes were provided principally by the treating CBT practitioners .", "In the trial , CBT showed no improvement in depression severity in the first four weeks and then some level of improvement over the subsequent eight weeks .", "Outcome was superior for those receiving antidepressant medication at 12 weeks and was first demonstrated at four weeks .", "The benefits of CBT appeared to be in settling anxiety , dealing with cognitive processing of having a melancholic depression and addressing any personality vulnerabilities .", "While a pilot study , our qualitative reports indicate that CBT may provide a useful role in managing melancholia as an adjunct to antidepressant medication .", "Future studies examining such a combination treatment model should seek to determine if indicative data provided here argue for a sequencing model of CBT being introduced after medication has addressed core biological underpinnings ." ]

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

[ "This study identified distinct tobacco use trajectories across 18months in 943 veteran smokers with posttraumatic stress disorder ( PTSD ) in order to describe quit and relapse patterns , examine associations between trajectory groups on baseline characteristics and cessation service utilization , and explore group differences in mental health outcomes .", "Veterans who participated in a multisite , randomized trial of integrated smoking cessation care were grouped using k-means clustering based on reported daily tobacco use between baseline and 18months .", "Four trajectory clusters were identified : no reduction ( 62 % ) , temporary reduction ( 11 % ) , late sustained reduction ( 9 % ) and early sustained reduction ( 18 % ) .", "Median quit times in the early , late , temporary , and no reduction groups were 451 , 141.5 , 97 , and 2days , respectively .", "Compared to the early reduction group , the temporary reduction group exhibited higher baseline depression ( p < 0.01 ) and anxiety ( p < 0.01 ) , but did not differ in treatment received , with both groups attending significantly more cessation visits ( p < 0.001 ) and more likely to receive recommended pharmacotherapy ( p < 0.001 ) than the no reduction group between baseline and 6months .", "The early reduction group exhibited lower depression relative to the no reduction ( p < 0.01 ) and temporary reduction ( p < 0.01 ) groups across all assessments between baseline and 18months .", "Differences were not observed between groups in depressive or PTSD symptom change over time between baseline and 18months .", "Tobacco use trajectories among treated smokers with PTSD vary distinctly .", "Characteristics of identified subgroups may lead to targeted interventions among smokers with PTSD and potentially other psychiatric disorders ." ]

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

[ "Uveal melanoma is the most common primary intraocular malignancy in adults .", "Despite successful control of the primary tumor , metastatic disease will ultimately develop in approximately 50 % of patients , with the liver being the most common site for metastases .", "The median survival for patients with liver metastases is between 6 and 12months , and no treatment has in randomized trials ever been shown to prolong survival .", "A previous phase II trial using isolated hepatic perfusion ( IHP ) has suggested a 14-month increase in overall survival compared with a historic control group consisting of the longest surviving patients in Sweden during the same time period ( 26 versus 12months ) .", "This is the protocol for a multicenter phase III trial randomizing patients with isolated liver metastases of uveal melanoma to IHP or best alternative care ( BAC ) .", "Inclusion criteria include liver metastases ( verified by biopsy ) and no evidence of extra-hepatic tumor manifestations by positron emission tomography-computed tomography ( PET-CT ) .", "The primary endpoint is overall survival at 24months , with secondary endpoints including response rate , progression-free survival , and quality of life .", "The planned sample size is 78 patients throughout five years .", "Patients with isolated liver metastases of uveal melanoma origin have a short expected survival and no standard treatment option exists .", "This is the first randomized clinical trial to evaluate IHP as a treatment option with overall survival being the primary endpoint .", "ClinicalTrials.gov registration number : NCT01785316 ( registered 1 February 2013 ) .", "EudraCT registration number : 2013-000564-29 ." ]

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

[ "To compare the influence of low-frequency ( 10-25 Hz ) versus higher ( 60-80 Hz ) frequency stimulation of the pedunculopontine nucleus area ( PPNa ) on akinaesia , freezing of gait and daytime sleepiness .", "We included nine patients with Parkinson 's disease ( PD ) and severe gait disorders .", "In this double-blind randomised cross-over study , patients were assessed after 24 h of PPNa stimulation .", "Assessments included the motor part of the Unified Parkinson 's Disease Rating Scale , the Epworth Sleepiness Scale and a behavioural gait assessment .", "Compared with 60-80 Hz , 10-25 Hz PPNa stimulation led to decreased akinaesia , gait difficulties and daytime sleepiness in 7/9 patients .", "In one patient , these symptoms were aggravated under 10-25 Hz stimulation compared with 60-80 Hz .", "These results are in keeping with the benefits of chronic PPNa stimulation for gait and postural difficulties in patients with PD , and with regard to the influence of patients ' clinical characteristics , differential neuronal loss in the PPNa and electrode location .", "We conclude that in patients with PPNa stimulation , low frequency provides a better outcome than high-frequency stimulation ." ]

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

[ "The present study is a prospective randomized double-blinded study that designed to evaluate and compare the effectiveness of postoperative pain control and incidence of complications between ilioinguinal/iliohypogastric nerve block and intravenous morphine in paediatric patients undergoing unilateral orchidopexy in day surgery unit .", "Seventy patients aged 2-12 years were randomly allocated to two groups of thirty five .", "One group received intravenous morphine 100 microgram/kg before skin incision and the other group had ilioinguinal/iliohypogastric nerve block with 0.25 ml/kg bupivacaine 0.5 % also before skin incision .", "All patients have received standardized anaesthesia .", "Postoperative pain was assessed using 0 - 10 scale at 0 , 1 , 2 , 3 and 4 postoperative hours , also the intraoperative fentanyl requirements , time to first postoperative analgesia , the total number of paracetamol doses and any extra analgesic requirements were recorded , side effects like respiratory depression , vomiting , itching , inguinal hematoma and lower limb weakness were assessed during the first 24 hours .", "Pain scores were significantly lower in the morphine group compared to the block group on admission and one hour after admission to the postanaesthesia care unit , no significant difference in pain score on 2nd , 3rd and 4th postoperative hours .", "The total number of intraoperative fentanyl doses was significantly higher in the block group compared to morphine group , there was no significant difference in the duration of analgesia , number of total paracetamol doses , need for extra analgesics in both groups over the 24 postoperative hours .", "None of the seventy patients experienced postoperative respiratory depression , inguinal hematoma or lower limb weakness , but significantly more patients in morphine group experienced vomiting and itching compared to the block group .", "Ilioinguinal/iliohypogastric nerve block and intravenous morphine administered following general anaesthesia for unilateral orchidopexy in day surgery unit are safe and effective in controlling postoperative pain , morphine analgesia had a higher incidence of postoperative vomiting and itching ." ]

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

[ "Right heart evaluation on coronary computed tomography angiography ( CCTA ) is underutilized due to nonopacification of the right heart chambers and poor endocardial resolution .", "We analyzed feasibility and reproducibility of right heart functional analysis by measuring CCTA-based tricuspid annular plane systolic excursion ( CT-TAPSE ) on ECG-gated CCTA and correlated the results with 2D transthoracic echocardiography ( TTE ) - derived TAPSE ( Echo-TAPSE ) .", "CT-TAPSE was measured on a total population of 41 patients who had CCTA and TTE performed within 6 months of each other .", "Two independent CCTA readers performed analysis on reformatted four-chamber view .", "Intra - and inter-observer variability analysis was performed on 16 randomly selected patients .", "Correlative ( Spearman 's R ) and Bland-Altman analysis was used to assess the level of agreement between the 2 methods and to compare CT-TAPSE with Echo-TAPSE .", "CT-TAPSE measured by Readers 1 and 2 on 16 randomly selected patients , demonstrated excellent intra-observer and inter-observer agreement , with very close correlation ( R > 0.80 and 2-tailed P-value of < 0.001 ) .", "When tested in the entire study population of 41 patients , CT-TAPSE correlated closely with Echo-TAPSE ( R = 0.738 , P < 0.001 ) .", "Bland-Altman analysis indicated that the 2 methods provided similar measures as majority of values lay within the 95 % confidence limits .", "Based on abnormal Echo-TAPSE cutoff value of < 16 mm , CT-TAPSE identified impaired right ventricle ( RV ) function with sensitivity of 82 % and specificity of 93 % , respectively .", "We demonstrated feasibility and reproducibility of assessing TAPSE on coronary CTA .", "RV functional analysis utilizing CT-TAPSE is simple and reproducible methodology , and is in close agreement with Echo-TAPSE ." ]

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

[ "To observe the therapeutic effect of Yangxue Tongluo Recipe ( YTR ) combined with immunosuppressive agents in the treatment of rheumatoid arthritis ( RA ) .", "Totally 88 RA patients were randomly assigned to the treatment group [ 47 cases , YTR combined Methotrexate ( MTX ) + Leflunomide ( LEF ) treatment ] and the control group ( 41 cases , MTX + LEF therapy ) .", "All patients received 12-week treatment .", "Clinical symptoms and signs , laboratory tests [ erythrocyte sedimentation rate ( ESR ) , rheumatoid factor ( RF ) , and C reactive protein ( CRP ) ] , and adverse reactions were observed before and after treatment .", "The total effective rate was 91.5 % ( 43/47 cases ) in the treatment group , and the total effective rate was 75.6 % ( 31/41 cases ) in the control group .", "There was statistical difference between the two groups ( P < 0.05 ) .", "The morning stiffness , the rest pain , the number of tender joints , the number of swollen joints , tender joint index , swollen joint index , ESR , RF , and CRP were significantly improved in the two groups after treatment ( P < 0.01 ) .", "Besides , clinical symptoms and signs , ESR , RF , and CRP were more improved in the treatment group after treatment , when compared with those in the control group ( P < 0.05 ) .", "Gastrointestinal discomfort was the main adverse reaction in the two groups , but the occurrence was lower in the treatment group than in the control group ( P > 0.05 ) .", "The clinical efficacy of YTR combined MTX + LEF in the treatment of RA was better than using Western medicine alone .", "It was more safe with less adverse reactions ." ]

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

[ "Randomised studies have demonstrated a beneficial effect of pre-surgical treatment with somatostatin analogues ( SSA ) in acromegaly when evaluated early postoperatively .", "The objective of this study was to evaluate the long-term surgical cure rates .", "Newly diagnosed patients were randomised to direct surgery ( n = 30 ) or 6-month pretreatment with octreotide LAR ( n = 32 ) .", "The patients were evaluated 1 and 5 years postoperatively .", "Cure was defined as normal IGF1 levels and by normal IGF1 level combined with nadir GH < 2mU/l in an oral glucose tolerance test , all without additional post-operative treatment .", "A meta-analysis using the other published randomised study with long-term analyses on preoperative SSA treatment was performed .", "The proportion of patients receiving post-operative acromegaly treatment was equal in the two groups .", "When using the combined criteria for cure , 10/26 ( 38 % ) macroadenomas were cured in the pretreatment group compared with 6/25 ( 24 % ) in the direct surgery group 1 year postoperatively ( P = 0.27 ) , and 9/22 ( 41 % ) vs 6/22 ( 27 % ) macroadenomas , respectively , 5 years postoperatively ( P = 0.34 ) .", "In the meta-analysis , 16/45 ( 36 % ) macroadenomas were cured using combined criteria in the pretreatment group vs 8/45 ( 18 % ) in the direct surgery group after 6-12 months ( P = 0.06 ) , and 15/41 ( 37 % ) vs 8/42 ( 19 % ) , respectively , in the long-term ( P = 0.08 ) .", "This study does not prove a beneficial effect of SSA pre-surgical treatment , but in the meta-analysis a trend towards significance can be claimed .", "A potential favourable , clinically relevant response can not be excluded ." ]

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

[ "Patients with chronic severe asthma ( CSA ) have a crippling disease and current available treatments are not satisfactory .", "Thus , management of CSA remains a major unmet need .", "Although the evidence from existing randomized controlled trials fails to support a definite role for immunomodulatory drugs in these patients due to major methodologic drawbacks , findings with low-dose methotrexate ( MTX ) are encouraging .", "However , larger and well-designed clinical trials are required to establish the beneficial role of MTX in CSA , and for the detection of the key characteristics of those who are going to respond to this drug .", "Patients will be recruited from the accessible asthmatic patients lists of tertiary referral centers .", "All patients will meet the stringent diagnostic criteria for CSA , including the requirement for the regular use of Global Initiative for Asthma ( GINA ) Global Strategy for Asthma Management and Prevention Step 5 medications ( oral prednisone and/or omalizumab ) .", "The experimental design of the proposed study will take the form of a double-blind parallel-randomized placebo-controlled trial consisting of a total of eight visits , including run-in and run-out periods .", "Patients will be randomly allocated to receive either MTX or a matched placebo once a week as an add-on therapy to their existing medication after run-in .", "Physiological , laboratory and clinical assessments will be measured regularly throughout the study and compared with baseline assessments .", "We expect that MTX will reduce Step 5 medications dosage in patients with CSA without compromising the overall disease control .", "Improvement in several indicators of asthma severity and control will be also investigated .", "ClinicalTrials.gov Identifier : NCT02124226 ( assigned 25 April 2014 ) ." ]

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

[ "Spinal anaesthesia performed at levels higher than the L3-4 intervertebral space may result in spinal cord injury .", "Our aim was to establish a protocol to reduce the chance of spinal anaesthesia performed at or above L2-3 .", "One hundred and ten consenting patients at 32weeks of gestation or greater scheduled for non-emergency caesarean section under spinal anaesthesia were randomly allocated to have needle insertion performed at an intervertebral space determined by one of two landmark techniques .", "In Group A , if the intercristal line intersected an intervertebral space , this space was selected or if the intercristal line intersected a spinous process the space immediately above was selected .", "In Group B , if the intercristal line intersected an intervertebral space or a spinous process , the intervertebral space immediately below was chosen .", "The actual intervertebral space chosen was identified using ultrasound by a blinded investigator .", "In Group A , an intervertebral space at or above L2-3 was marked in 25 ( 45.5 % ) patients compared with 4 ( 7.3 % ) in Group B ( P < 0.001 ) .", "In 5/55 ( 9.1 % ) patients in Group A , the intervertebral space initially chosen was L1-2 whereas this occurred in no patient in Group B.", "There was no difference between groups in number of needle passes or attempts , onset of block at 5 , 10 and 15min or need for rescue analgesia .", "Our data suggest that when performing spinal anaesthesia in pregnant patients , if the intercristal line intersects an intervertebral space then the space below should be chosen and if the intercristal line intersects a spinous process then the interspace below should be chosen .", "This will reduce the incidence of spinal anaesthesia performed at or above L2-3 ." ]

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

[ "The effectiveness of continuous renal replacement therapy ( CRRT ) increases when unplanned circuit failure is prevented .", "Adequate anticoagulation is an important component .", "Although heparin is the predominating anticoagulant , calcium chelation with citrate is an alternative , but systemic calcium monitoring and supplementation increase the complexity of CRRT .", "We assessed efficacy and safety of citrate delivery via integrated software algorithms against an established regional heparin protocol .", "Prospective computer randomisation allocated eligible patients to regional citrate or heparin between April and December 2012 .", "Citrate fluids were Prismocitrate 18 mmol/L predilution and Prism0cal B22 dialysate .", "Hemosol B0 was the default fluid for heparin .", "The primary outcome was filter running time .", "Electively terminated circuits were censored .", "Intention-totreat ( ITT ) and per-protocol analyses were performed .", "Filter survival was compared by log-rank tests and hazard ratios were explored with a mixed-effects Cox model .", "221 filters were analysed from 30 patients ( of whom 19 were randomly allocated to citrate filters and 11 to heparin filters ) .", "Patients randomly allocated to citrate were older , sicker , with a higher male : female ratio , but of similar weight .", "Mortality was 37 % in the citrate arm and 27 % in the heparin arm .", "All deaths were attributed to underlying disease .", "Significant crossover occurred from the citrate arm to use of heparin .", "Median filter survival , by ITT , was not significantly different ( citrate , 34 hours ; heparin , 30.7 hours ; P = 0.58 ) .", "Per-protocol survival favoured citrate ( citrate , 42.1 hours ; heparin , 24 hours ; ( 2 ) = 8.1 ; P = 0.004 ) .", "Considerable variation in filter life existed between patients , and between vascular access sites within patients .", "Safety end points were reached in one heparin and three citrate patients .", "Although the per-protocol results favoured citrate when it was actually delivered , the significant crossover between treatment arms hampered more definitive conclusions .", "Until further studies support improved patient outcomes , increased complexity and complications suggest that anticoagulation choice be made using patient-specific indications ." ]

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

[ "To assess objective and subjective outcomes of retrograde intrarenal surgery ( RIRS ) and extracorporeal shock wave lithotripsy ( SWL ) for the treatment of intermediate size ( 1-2 cm ) inferior calyceal ( IC ) stones in a prospective randomized fashion .", "Between March 2011 and January 2013 , 70 symptomatic adults who had isolated IC stone between 10 and 20 mm underwent RIRS or SWL by computer-generated pseudorandom assignment ( 1:1 ) .", "Success rate , mean procedure time , hospital stay , pain score on day 1 and 2 using visual analog scale , analgesic requirement after discharge , complications , retreatment rate , auxiliary procedure , and patient-reported outcomes ( using self-made nonvalidated questionnaire ) were compared .", "Baseline parameters and mean stone size ( SWL 16.45 2.28 mm , RIRS 15.05 3.56 mm ; P = .0542 ) were comparable .", "Success rate was significantly higher after a single session of RIRS compared with 3 sessions of SWL ( 85 % vs 54 % ; P = .008 ) .", "Retreatment rate ( 65 % vs 5.7 % ; P = .0001 ) and auxiliary procedure ( 45 % vs 8 % ; P = .0009 ) were significantly higher in SWL .", "Pain score on postoperative day 1 and 2 was significantly higher in RIRS , but patients with SWL required significantly more analgesics afterward .", "Most of the complications were of Clavien grade I and/or II in both groups .", "Average time to return to normal activity and voiding symptoms were significantly higher in RIRS .", "Overall satisfaction score ( 2.17 1.24 vs 2.82 1.17 ; P = .026 ) was significantly higher in RIRS than SWL .", "For the treatment of intermediate size IC calculi , RIRS is superior to SWL in terms of objective and subjective outcomes ." ]

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

[ "To compare macular hole ( MH ) closure and visual acuity improvement after vitrectomy using SF6 versus C3F8 gas tamponade .", "The secondary purposes were to report the cumulative incidence of cataract development at 1 year after MH surgery and the proportion of complications .", "Prospective , randomized study .", "Thirty-one patients were prospectively randomized to the SF6 group and 28 patients to the C3F8 group .", "Preoperative data included MH minimum diameter , Early Treatment Diabetic Retinopathy Study ( ETDRS ) best corrected visual acuity ( BCVA ) , cataract staging , and intraocular pressure ( IOP ) measurement .", "Postoperative data included optical coherence tomography confirmation of the closure at 6 weeks and 1 year , and ETDRS BCVA and cataract development/extraction , both 1 year after the MH surgery .", "Primary MH closure was achieved in 93.3 % in the SF6 group and 92.9 % in the C3F8 group .", "Mean ETDRS BCVA improved by 17.7 letters in the SF6 and 16.9 letters in the C3F8 group .", "The difference in cumulative incidence of cataract development and extraction between both groups was not statistically significant .", "Regardless of the dye used , similar results were achieved .", "Finally , the proportion of adverse events was similar in both groups .", "MH surgery with SF6 gas achieves results similar to C3F8 in terms of visual acuity improvement , MH closure , cataract development/extraction , and adverse events ." ]

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

[ "Patients with latent autoimmune diabetes in adults ( LADA ) express autoantibodies against the 65-kDa isoform of GAD ( GADA ) .", "Intervention with recombinant human GAD65 formulated with aluminium hydroxide ( GAD-alum ) given twice subcutaneously to LADA patients at intervals of 4 weeks was safe and did not compromise - cell function in a Phase II clinical trial .", "GADA affinity has been shown to predict progression to type 1 diabetes .", "Here , we asked whether GADA affinity was affected by the GAD65 antigen-specific vaccination and/or associated with - cell function in participants of this trial .", "GADA affinity was measured in sera of 46 LADA patients obtained prior to the first week and 20 weeks after the second injection with GAD-alum or placebo using competitive binding experiments with [ 125I ] - labeled and unlabeled human GAD65 .", "At baseline , GADA affinities ranged from 1.9 10 ( 7 ) to 5.0 10 ( 12 ) L/mol ( median 2.8 10 ( 10 ) L/mol ) and were correlated with GADA titers ( r = 0.47 ; P = 0.0009 ) , fasting ( r = -0.37 ; P = 0.01 ) and stimulated ( r = -0.40 ; P = 0.006 ) C-peptide concentrations , and HbA1c ( r = 0.39 ; P = 0.007 ) .", "No significant changes in affinity were observed from baseline to week 24 .", "Patients with GADA affinities in the lower first quartile ( < 4 10 ( 9 ) L/mol ) had better preserved fasting C-peptide concentrations at baseline than those with higher affinities ( mean 1.02 vs. 0.66 nmol/L ; P = 0.004 ) and retained higher concentrations over 30 months of follow-up ( mean 1.26 vs. 0.62 nmol/L ; P = 0.01 ) .", "Intervention with GAD-alum in LADA patients had no effect on GADA affinity .", "Our data suggest that patients with low GADA affinity have a prolonged preservation of residual - cell function ." ]

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

[ "Few studies support oral diabetic treatment in pregnant women with type 2 diabetes mellitus ( T2DM ) .", "The objective of this study was to compare the effects of metformin versus insulin on achieving glycemic control and improving maternal and neonatal outcomes in pregnant women with T2DM .", "A pilot randomized , controlled trial was conducted of metformin versus insulin for the treatment of T2DM during pregnancy .", "The primary outcome was glycemic control measured with hemoglobin A1c < 7 % at delivery .", "Maternal and neonatal outcomes were compared between groups .", "In this study , 8 women received metformin and 11 received insulin .", "All women in both groups achieved glycemic control by delivery ( HgbA1c : metformin 5.965.88 vs. insulin 6.340.92 % ) .", "There were similar rates of cesarean delivery , birth weights , neonatal intensive care unit admissions , respiratory distress syndrome , and neonatal dextrose treatment between groups .", "There was one case of fetal macrosomia in the insulin group , one case of shoulder dystocia in the metformin group and no cases of failed metformin therapy .", "In this pilot study , glycemic control was achieved in women who received metformin and insulin .", "Larger studies are needed to determine whether metformin can be considered a reasonable alternative to insulin in pregnant women with T2DM ." ]

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

[ "This in vitro study compared the effect of a concave with a straight-bevelled cavity margin on the microleakage of Class V composite resin restorations in primary teeth .", "Standardised Class V cavity preparations were made in vitro on the buccal ( all margins placed in enamel ) and on the lingual ( margins placed in enamel and cementum ) surfaces of 20 sound primary molars .", "The teeth were randomly assigned to two groups of 10 each : in Group 1 , a concave bevel was made with a high-speed No. 04 tungsten carbide bur and in Group 2 , a straight bevel was made with a high-speed No. 556 tungsten carbide bur .", "The teeth were restored incrementally with Adper Single Bond 2 ( 3M ) adhesive and Filtek Z 350 ( 3M ) composite resin .", "All specimens were subsequently thermocycled and immersed in 50 % silver nitrate solution .", "Microleakage of the restorations was then assessed by silver penetration .", "A grading scale of 0 to 4 was used as the scoring criterion .", "At the enamel margins no statistically significant differences were observed between the two groups ( p >> 0.05 ) .", "Occlusal walls in enamel , in both groups , exhibited less leakage than the cervical walls in cementum ( p < 0.01 ) and Group 1 showed better results than Group 2 in decreasing microleakage at the cementum margins ( p < 0.05 ) .", "Based on the results , it was concluded that concave-beveled cavity preparations may reduce but did not totally eliminate microleakage at the cementum margins of Class V composite resin restorations in primary teeth ." ]

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

[ "Computerized tomography DICOM file can be relatively easily transformed to a virtual 3D model .", "With the help of additional software we are able to create the mirrored model of an undamaged orbit and on this basis produce an individual implant for the patient Authors decided to apply implants with any thickness , which are authors own invention to obtain volumetric support and more stable orbital wall reconstruction outcome .", "Material of choice was ultra-high molecular weight polyethylene ( UHMWPE ) .", "The aim of this study was to present and compare functional results of individual reconstructions of orbital wall using either titanium mesh or ultra-high molecular weight polyethylene .", "57 consecutive patients affected by orbital wall fracture ( 46 males , 11 females , mean age 3414 year ) were treated in Department of Maxillofacial Surgery from 2010 to 2012 .", "In the first group we used patient specific treatment by titanium mesh shaped on a 3D printed model of a mirrored intact orbit ( 37 orbits ) or by individually manufactured UHMW-PE implantby CAM milling in second group ( 20 orbits ) .", "All of these patients were subjected to preoperative helical computerized tomography and consultation of an ophthalmologist ( including binocular single vision loss test - BSVL ) .", "Further on , patients were operated under general anaesthesia using transconjuctival approach .", "BSVL was again evaluated post-operationally in 1 month and 6 months later .", "Functional treatment results ( BSVL ) for both groups were similar in 1 month as well as 6 months post operational time .", "There was no statistically significant difference between these two groups .", "This study of 6 months functional result assessment of pre-bent individual implants and CNC milled ultra-high molecular weight polyethylene of the orbital wall has shown it to be a predictable reconstruction method .", "Individually shaped UHMWPE seems to be as good as pre-bent titanium mesh ." ]

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

[ "To assess the effect of a capsular tension ring ( CTR ) on the postoperative anterior chamber depth ( ACD ) .", "Vienna Institute for Research in Ocular Surgery , Department of Ophthalmology , Hanusch Hospital , Vienna , Austria .", "Prospective observer - and patient-masked randomized trial .", "Bilateral small-incision cataract surgery with implantation of a hydrophobic acrylic single-piece intraocular lens ( IOL ) ( Tecnis ZCB00 ) was performed using a standard technique .", "Each patient received a CTR in 1 eye ( CTR group ) and no CTR in the fellow eye ( control group ) .", "The ACD was measured preoperatively with biometry ( IOLMaster 500 ) and at 1 hour and 12 weeks postoperatively using partial coherence interferometry ( ACMaster ) .", "The subjective refraction was assessed at 12 weeks .", "Sixty eyes ( 30 patients ) were included .", "Preoperatively , the mean axial length was 23.36 mm 1.55 ( SD ) ( range 21.01 to 29.46 mm ) in the CTR group and 23.37 1.70 mm ( range 21.14 to 28.84 mm ) in the control group and the mean ACD was 3.06 0.45 mm ( range 2.25 to 4.16 mm ) and 3.03 0.47 mm ( range 2.18 to 4.10 mm ) , respectively .", "The differences were not statistically significant ( P = .148 and P = .074 , respectively ) .", "The mean postoperative ACD was 4.83 0.46 mm ( range 3.84 to 5.76 mm ) in the CTR group and 4.81 0.43 mm ( range 3.67 to 5.65 mm ) in the control group .", "The difference between the groups was not statistically significant ( P = .329 ) .", "Implantation of a CTR had no significant influence on the postoperative axial IOL position .", "No author has a financial or proprietary interest in any material or method mentioned ." ]

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

[ "Transfused blood may have immunomodulatory and proinflammatory effects .", "We report the first randomized study exploring whether leukoreduced red blood cell ( RBC ) transfusion increases circulating proinflammatory mediators , markers of neutrophil activation , and the acute-phase response in critically ill adults .", "Eighty-four patients were recruited from six general intensive care units in the United Kingdom as part of a laboratory study nested within a parallel-group randomized trial comparing restrictive and liberal leukoreduced RBC transfusion strategies in critically ill patients aged more than 55years with measured hemoglobin concentrations of not more than 90g/L ( ClinicalTrials.gov NCT00944112 ) .", "Forty-one patients received transfusion and 43 did not receive transfusion .", "Plasma was sampled at baseline , 6 hours , and 24 hours after randomization or transfusion , and concentrations of interleukin ( IL ) -1 , IL-2 , IL-4 , IL-5 , IL-6 , IL-8 , IL-10 , IL-12-p70 , interferon - , tumor necrosis factor - , human neutrophil elastase , soluble L-selectin , and C-reactive protein were measured using cytokine bead array analysis and an enzyme-linked immunosorbent assay .", "Patients who received transfusion did not have significantly different inflammatory biomarker plasma concentrations at the time points compared to those who did not receive transfusion , with the exception of IL-8 concentrations at 24 hours , which were reduced in the transfused group ( p = 0.02 ) .", "After adjustment for baseline inflammatory biomarker concentrations , there were no significant differences between patients who received transfusion and those who did not .", "Concentrations of measured biomarkers were not significantly increased during the first 24 hours after leukoreduced RBC transfusion .", "These data do not support the contention that leukoreduced RBC transfusion is associated with a proinflammatory response in the general adult critically ill population ." ]

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

[ "To evaluate the influence of estrogen therapy and estrogen-progestin therapy on homocysteine and C-reactive protein levels in postmenopausal women .", "In total , 99 postmenopausal women were included in this double-blind , randomized clinical trial and divided into three groups : Group A used estrogen therapy alone ( 2.0 mg of 17-estradiol ) , Group B received estrogen-progestin therapy ( 2.0 mg of 17 - estradiol +1.0 mg of norethisterone acetate ) and Group C received a placebo ( control ) .", "The length of treatment was six months .", "Serum measurements of homocysteine and C-reactive protein were carried out prior to the onset of treatment and following six months of therapy .", "After six months of treatment , there was a 20.7 % reduction in homocysteine levels and a 100.5 % increase in C-reactive protein levels in the group of women who used estrogen therapy .", "With respect to the estrogen-progestin group , there was a 12.2 % decrease in homocysteine levels and a 93.5 % increase in C-reactive protein levels .", "Our data suggested that hormone therapy ( unopposed estrogen or estrogen associated with progestin ) may have a positive influence on decreasing cardiovascular risk due to a significant reduction in homocysteine levels ." ]

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

[ "Optimal pain management after video-assisted thoracic surgery ( VATS ) remains an open issue .", "We prospectively studied the analgesic effect of intercostal analgegia ( ICA ) by comparison with epidural analgesia .", "Twenty-two patients undergoing VATS procedures were randomly divided into ICA ( n = 8 ) or epidural ( n = 14 ) group .", "Postoperatively 2 ml x hr ( -1 ) of 0.2 % ropivacaine was delivered continuously through intercostal or epidural catheter .", "Moreover , each group received the equal dose of fentanyl ( 0.25 x g ( -1 ) .", "kg ( -1 ) x hr ( -1 ) ) intravenously or epidurally .", "When no pain relief was achieved , iv fentanyl was given as a rescue .", "Requirement of additional fentanyl and pain score using a visual analogue scale ( VAS ) were documented for 19 hours .", "The mean pain scores at rest , mobilization and with coghing were slightly higher in the ICA group .", "Total additional dose of iv fentanyl was significantly different between the groups ( ICA 147 41 vs Epidural 39 15 g ; P = 0.015 ) .", "Pain scores and fentanyl requirements spread over the lower range .", "The mean of VAS in ICA group was less than 5 even at coughing , suggesting clinically irrelevant .", "In patients with coagulopathy , multimodal approach using intercostal analgesia supplemented by intravenous patient-controlled analgesia may be an alternative to epidural analgesia for postoperative pain management ." ]

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

[ "A/H3N2 variant ( H3N2v ) influenza may sustain human-to-human transmission , and an available candidate vaccine would be important .", "In this phase I , randomized , observer-blind , dose-ranging study , 627 healthy subjects 3 years of age were randomized to receive 2 vaccinations with H3N2c cell-culture-derived vaccine doses containing 3.75 g , 7.5 g , or 15 g hemagglutinin antigen of H3N2v with or without MF59 ( registered trademark of Novartis AG ) adjuvant ( an oil-in-water emulsion ) .", "This paper reports Day 43 planned interim data .", "Single MF59-adjuvanted H3N2c doses elicited immune responses in almost all subjects regardless of antigen and adjuvant dose ; the Center for Biologics Evaluation Research and Review ( CBER ) licensure criteria were met for all groups .", "Subjects with prevaccination hemagglutination inhibition titers < 10 and children 3 - < 9 years achieve CBER criteria only after receiving 2 doses of nonadjuvanted H3N2c vaccine .", "Highest antibody titers were observed in the 7.5 g + 0.25 mL MF59 groups in all age cohorts .", "MF59-adjuvanted H3N2c vaccines showed the highest rates of solicited local and systemic events , predominately mild or moderate .", "A single dose of H3N2c vaccine may be immunogenic and supports further development of MF59-adjuvanted H3N2c vaccines , especially for pediatric populations .", "ClinicalTrials.gov identifier NCT01855945 ( http://clinicaltrials.gov/ct2/show/NCT01855945 ) ." ]

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

[ "Insomnia , which is very common in patients with chronic low back pain ( LBP ) , has long been viewed as a pain symptom that did not merit specific treatment .", "Recent data suggest that adding insomnia therapy to pain-targeted treatment should improve outcome ; however , this has not been empirically tested in LBP or in any pain condition treated with a standardized pain medication regimen .", "We sought to test the hypothesis that adding insomnia therapy to pain-targeted treatment might improve sleep and pain in LBP .", "Double-blind , placebo-controlled , parallel-group , 1-mo trial .", "Duke University Medical Center Outpatient Sleep Clinic .", "Fifty-two adult volunteers with LBP of at least 3 mo duration who met diagnostic criteria for insomnia ( mean age : 42.5 y ; 63 % females ) .", "Subjects were randomized to eszopiclone ( ESZ ) 3 mg plus naproxen 500 mg BID or matching placebo plus naproxen 500 mg twice a day .", "ESZ SIGNIFICANTLY IMPROVED TOTAL SLEEP TIME ( MEAN INCREASE : ESZ , 95 min ; placebo , 9 min ) ( primary outcome ) and nearly all sleep measures as well as visual analog scale pain ( mean decrease : ESZ , 17 mm ; placebo , 2 mm ) ( primary pain outcome ) , and depression ( mean Hamilton Depression Rating Scale improvement ESZ , 3.8 ; placebo , 0.4 ) compared with placebo .", "Changes in pain ratings were significantly correlated with changes in sleep .", "The addition of insomnia-specific therapy to a standardized naproxen pain regimen significantly improves sleep , pain , and depression in patients with chronic low back pain ( LBP ) .", "The findings indicate the importance of administering both sleep and pain-directed therapies to patients with LBP in clinical practice and provide strong evidence that improving sleep disturbance may improve pain .", "clinicaltrials.gov identifier : NCT00365976 ." ]

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

[ "The present study investigated the immediate effects of low frequency repetitive transcranial magnetic stimulation ( LF-rTMS ) combined with reach-to-grasp ( RTG ) training of the paretic hand in individuals with chronic stroke .", "Fourteen participants were randomly assigned to receive LF-rTMS or sham stimulation conditions .", "All participants underwent RTG training after the stimulation .", "Corticospinal excitability ( CE ) of the non-lesioned hemisphere , the total time of the wolf motor function test ( WMFT ) for dexterity tasks , maximum aperture , and movement time of RTG actions were evaluated at baseline , after the stimulation , and after RTG training .", "Significant differences between interaction ( group x time ) were found in the total time of WMFT The CE of non-lesioned hemisphere diminished after LF-rTMS and showed moderate correlation with the reduction in time of RTG actions after the stimulation .", "The total time of WMFT and RTG actions reduced after motor training only in the LF-rTMS group .", "No change was observed in maximum aperture in either group .", "The application of LF-rTMS combined with RTG training enhanced the training effect as evidenced by faster movement for the dexterity tasks of the paretic hand than RTG training alone .", "The findings suggested the benefit of LF-rTMS for enhancing the training effects in stroke rehabilitation ." ]

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

[ "Whether therapeutic drug monitoring of biologic therapy can predict the efficacy of adalimumab to prevent postoperative Crohn 's disease recurrence is unknown .", "To investigate whether adalimumab trough levels and anti-adalimumab antibodies correlate with endoscopic and clinical outcomes in a series of patients treated with prophylactic adalimumab monotherapy after resective surgery .", "Post hoc analysis of a randomized , mesalamine-controlled trial .", "Adalimumab trough levels and antibodies were analysed every 8 weeks for 2 years using an homogeneous mobility shift assay .", "At two years , 1/6 patient had clinical recurrence and 1/6 patient had endoscopic and clinical recurrence .", "At baseline ( 9.5 vs. 14.4 mcg/mL ) and during follow-up [ 7.5 ( 4.4-9 .8 ) vs. 13.9 ( 8.9-23 .6 ) mcg/mL , p < 0.01 ] , median adalimumab trough levels in patients with clinical or endoscopic recurrence were lower than in those who maintained remission .", "Persistent antibodies-against-adalimumab were detected in the patient with both endoscopic and clinical recurrence .", "Measurement of adalimumab trough levels and anti-adalimumab antibodies after surgery could be useful to further reduce postoperative recurrence ." ]

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

[ "We showed previously that rabbit ATG induction induces a strong decrease of CD4 + T cells together with impaired in vitro IL-2 secretion up to 1 year post-transplant .", "To further characterize long-term immunological effects of ATG induction 2 and 5 years post-transplant , we used sensitive intracellular cytokine analysis in the same prospective study of 84 renal transplant recipients ( ATG , n = 44 ) .", "A significantly increased frequency of severe infectious disease ( HR = 2.0 , p = 0.027 ) as well as suppressed T cell functions were found within 2 years after ATG induction but not beyond ( logistic regression ( logreg ) : CD4 cell IL-10 responses , p = 0.064 ; T cell proliferation , p = 0.038 ) .", "Impaired T cell proliferation at 2 years was associated with occurrence of severe infection ( p = 0.017 ) .", "Importantly , a strong and persistent decrease of CD4 cell counts ( p < 0.0005 at 5 years ) was independently associated with ATG induction ( logreg p = 0.002 ) but not related to functional CD4 cell impairment ( helper activity/cytokine production ) or an increased risk of infection .", "Severe infection up to 2 years after ATG induction was associated with impaired T cell proliferative capacity but not with the profound decline in CD4 cell counts that occurred after ATG induction and persisted up to 5 years ." ]

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

[ "To compare anxiolysis produced by intranasal clonidine with intranasal midazolam as premedication in children undergoing surgery .", "Double-blind randomized controlled study .", "Tertiary-care hospital , July 2009 to June 2010 .", "60 American Society of Anesthesiologists physical status I-II surgical patients aged 1-10 yr .", "Participants randomly allocated to receive either intranasal clonidine 4 mcg/kg ( Group I ) with atropine or intranasal midazolam 0.3 mg/kg ( Group II ) .", "Primary : satisfactory anxiolysis at 30 min after drug administration .", "Secondary : satisfactory mask acceptance , times of onset of sedation and anxiolysis , drug acceptance , level of sedation , wake-up score and side effects .", "All children achieved satisfactory anxiolysis at 30 min .", "Group I fared significantly better than GroupII on mask acceptance ( 100 % in Group I vs. 80 % in Group II ; P = 0.024 ) , drug acceptance ( 93 % vs. 13 % ; P < 0.001 ) and proportion of patients with satisfactory wake up scores ( 100 % vs. 53 % ; P < 0.001 ) .", "Group II patients had significantly faster onset of sedation ( median 10 min vs. 15 min ; P < 0.05 ) but not that of anxiolysis compared to Group-I ( median 10 min for both groups ; P > 0.05 ) .", "Side effects were significantly more frequent in Group II .", "Though intranasal midazolam produced faster sedation , both the drugs produced satisfactory anxiolysis at 30 min ." ]

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

[ "Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials .", "The Silent Cerebral Infarct Multi-Center Clinical ( SIT ) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children .", "Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease ( SCD ) and silent cerebral infarct ( SCI ) in the SIT Trial after initial consent .", "Differences in socio-economic and demographic variables , family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent .", "Head of household educational level and family income were examined separately for US versus non-US sites .", "Of 1,176 children enrolled in the SIT Trial , 1,016 ( 86 % ) completed screening .", "Of 208 ( 20 % ) children with qualifying SCI on pre-randomization MRI , 196 ( 94 % ) were successfully randomized .", "There were no differences in socio-economic , demographic , or disease-related variables between children who were or were not randomized .", "Participants from non-US sites were more likely to be randomized ( 22 % vs. 12 % , P = 0.011 ) ; although , randomization by country was associated with neither head of household education nor family income .", "In the SIT Trial , acceptance of random allocation was not associated with socio-economic or demographic factors .", "Although these factors may represent barriers for some participants , they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation ." ]

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

[ "Acute pain is common during the endotracheal extubation period , and is related to complications and adverse outcomes .", "Patients with delayed extubation after craniotomy are vulnerable to pain and complications of extubation .", "However , pain control during extubation is still inadequate .", "Remifentanil , a new opioid with rapid onset and short duration of action , provides adequate analgesia during procedures with minimal effect of respiratory depression .", "The study is a prospective , randomised , double-blinded , controlled parallel-group design .", "Patients with delayed extubation after intracranial surgery are screened daily .", "Adult patients ready for extubation are enrolled and assigned randomly to one of the two treatment study groups , labelled as the ` Remi group ' or ` Saline group ' .", "Patients in the Remi group receive an intravenous bolus dose of remifentanil 0.5 g/kg over 60s followed by a continuous infusion 0.05 g/kg/min for 20min .", "Patients in the Saline group receive an intravenous infusion of 0.9 % sodium chloride at a volume and rate equal to that of remifentanil .", "Pain intensity is measured by the visual analogue scale ( VAS ) pain score .", "Adverse events during drug infusion are documented and reported .", "Patients will be followed up until hospital discharge , death or 60days after the trial intervention on a first come , first served basis .", "Details of the incidence of reintubation and reoperation within 72h after extubation , length of stay in the intensive care unit and hospital and mortality are collected .", "The primary end point is the incidence of severe pain ( defined as a VAS pain score more than 5cm ) during the periextubation period ( defined as the period of time from immediately before extubation to 20min after extubation ) .", "The study was approved by the Institutional Review Board ( IRB ) of the Beijing Tiantan Hospital , Capital Medical University .", "The study findings will be disseminated through peer-reviewed publications and conference presentations .", "ClinicalTrials ( NCT ) : ChiCTR-PRC-13003879 ." ]

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

[ "Virtually no clinical trials for smoking cessation have been undertaken in bipolar disorder .", "Varenicline has shown efficacy for smoking cessation , but warnings about neuropsychiatric adverse events have been issued .", "We assessed the efficacy and safety of varenicline in euthymic bipolar subjects motivated to quit smoking .", "Clinically stable adult patients with DSM-IV bipolar disorder ( n = 60 ) who smoked 10 cigarettes per day were randomized to a 3-month , double-blind , placebo-controlled varenicline trial and a 3-month follow-up .", "Study enrollment was completed from February 2010 through March 2013 .", "Varenicline was dosed using standard titration , and smoking cessation counseling was provided to all patients .", "The primary outcome was defined as a 7-day point prevalence of self-reported no smoking verified by expired carbon monoxide level < 10 ppm at 12 weeks .", "Psychopathology and side-effects were assessed at each visit .", "At 3 months ( end of treatment ) , significantly more subjects quit smoking with varenicline ( n/n = 15/31 , 48.4 % ) than with placebo ( n/n = 3/29 , 10.3 % ) ( OR = 8.1 ; 95 % CI , 2.03-32 .5 ; P < .002 ) .", "At 6 months , 6 of 31 varenicline-treated subjects ( 19.4 % ) remained abstinent compared to 2 of 29 ( 6.90 % ) assigned to placebo ( OR = 3.2 ; 95 % CI , 0.60-17 .6 ; P = .17 ) .", "Psychopathology scores remained stable .", "Ten serious adverse events occurred ( n = 6 , varenicline ; n = 4 , placebo ) .", "Abnormal dreams occurred significantly more often in varenicline-treated subjects ( n/n = 18/31 , 61.3 % ) than in those receiving placebo ( n/n = 9/29 , 31 % ; Fisher exact test , P = .04 ) .", "Eight varenicline-treated and 5 placebo-assigned subjects expressed fleeting suicidal ideation , a nonsignificant difference .", "Varenicline shows efficacy for initiating smoking cessation in bipolar patients , but medication trials of longer duration are warranted for maintaining abstinence .", "Vigilance for neuropsychiatric adverse events is prudent when initiating varenicline for smoking cessation in this patient population .", "ClinicalTrials.gov identifier : NCT01010204 ." ]

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

[ "To examine the stability of severe pediatric obesity relative to moderate obesity and associated changes in cardiometabolic risk from the beginning of 6th to the end of 8th grade .", "Participants in HEALTHY , a multi-site , cluster randomized school-based study designed to mitigate risk for type 2 diabetes , completed standardized assessments of height , weight , glucose , insulin , lipids , and blood pressure at the beginning of 6th grade and the end of 8th grade .", "Youth were classified as moderately obese ( 100-119 % of the 95th percentile of BMI for age and gender ) or severely obese ( 120 % of the 95th percentile of BMI for age and gender ) .", "Generalized linear mixed models ( GLMM ) that controlled for relevant covariables were used to examine the relation between baseline demographic and cardiometabolic risk factors and BMI status , as well as changes in relative weight category and risk factors during middle school .", "Severe obesity was more likely to endure over the course of middle school than was moderate obesity , and was associated with significantly higher levels of cardiometabolic risk .", "Research with a specific focus on understanding , preventing , and treating severe obesity in children is warranted ." ]

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

[ "Infections caused by carbapenemase-producing Enterobacteriaceae are increasing worldwide , especially in ICUs , and have been associated with high mortality rates .", "However , unequivocally demonstrating causality of such infections to death is difficult in critically ill patients because of potential confounding and competing events .", "Here , we quantified the effects of carbapenemase-producing Enterobacteriaceae carriage on patient outcome in two Greek ICUs with carbapenemase-producing Enterobacteriaceae endemicity .", "Observational cohort study .", "Two ICUs with carbapenemase-producing Enterobacteriaceae endemicity .", "Patients admitted to the ICU with an expected length of ICU stay of at least 3 days were included .", "None .", "Carbapenemase-producing Enterobacteriaceae colonization was established through screening in perineum swabs obtained at admission and twice weekly and inoculated on chromogenic plates .", "Detection of carbapenemases was performed phenotypically , with confirmation by polymerase chain reaction .", "Risk factors for ICU mortality were evaluated using cause-specific hazard ratios and subdistribution hazard ratios , with carbapenemase-producing Enterobacteriaceae colonization as time-varying covariate .", "One thousand seven patients were included , 36 ( 3.6 % ) were colonized at admission , and 96 ( 9.5 % ) acquired carbapenemase-producing Enterobacteriaceae colonization during ICU stay , and 301 ( 29.9 % ) died in ICU .", "Of 132 carbapenemase-producing Enterobacteriaceae isolates , 125 ( 94.7 % ) were Klebsiella pneumoniae and 74 harbored K. pneumoniae carbapenemase ( 56.1 % ) , 54 metallo -- lactamase ( 40.9 % ) , and four both ( 3.0 % ) .", "Carbapenemase-producing Enterobacteriaceae colonization was associated with a statistically significant increase of the subdistribution hazard ratio for ICU mortality ( subdistribution hazard ratio = 1.79 ; 95 % CI , 1.31-2 .43 ) , not explained by an increased daily hazard of dying ( cause-specific hazard ratio for death = 1.02 ; 95 % CI , 0.74-1 .41 ) , but by an increased length of stay ( cause-specific hazard ratio for discharge alive = 0.73 ; 95 % CI , 0.51-0 .94 ) .", "Other risk factors in the subdistribution hazard model were Acute Physiology and Chronic Health Evaluation II score ( subdistribution hazard ratio = 1.13 ; 95 % CI , 1.11-1 .15 ) , female gender ( subdistribution hazard ratio = 1.29 ; 95 % CI , 1.02-1 .62 ) , presence of solid tumor ( subdistribution hazard ratio = 1.54 ; 95 % CI , 1.15-2 .06 ) , hematopoietic malignancy ( subdistribution hazard ratio = 1.61 ; 95 % CI , 1.04-2 .51 ) , and immunodeficiency ( subdistribution hazard ratio = 1.59 ; 95 % CI , 1.11-2 .27 ) .", "Patients colonized with carbapenemase-producing Enterobacteriaceae have on average a 1.79 times higher hazard of dying in ICU than noncolonized patients , primarily because of an increased length of stay ." ]

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

[ "The extubation phase is an extremely critical moment in patients who have undergone orthotopic liver transplantation , who do not always have the advantage of long-lasting positive-pressure ventilation and positive expiratory end pressure ; these factors can lead to splanchnic venous congestion , and this is why a rapid extubation can represent a great benefit for the graft .", "The aim of this study was to compare the adaptive support ventilation ( ASV ) mode with the standard mode of weaning in our intensive care unit , synchronized intermittent mandatory ventilation with pressure support ( P-SIMV ) , in patients who received orthotopic liver transplantation .", "ASV is a positive-pressure mode , in which pressure level and respiratory rate are automatically adjusted according to measured lung dynamics at each breath .", "Eligible patients were assigned to either ASV or P-SIMV group .", "The weaning protocol was based on the individual respiratory activity and structured in 4 different phases .", "The average length of intubation was significantly shorter in the ASV group than in the P-SIMV group ( 9013 vs 15322 minutes , P = .05 ) .", "The total modifications to the ventilator settings were significantly larger in the P-SIMV group ( 1.51 vs 62 ; P = .003 ) .", "Our results suggest that although both procedures are safe and easy to apply , ASV is superior in terms of weaning times , and it simplifies respiratory management .", "The better patient-machine interaction in ASV has been highlighted by other authors for different clusters of patients ." ]

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

[ "In the international randomised phase 3 CORRECT trial ( NCT01103323 ) , regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer .", "Of the 760 patients in CORRECT , 111 were Asian ( mostly Japanese ) .", "This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT .", "In this randomised , double-blind , placebo-controlled , parallel-group , phase 3 trial done in 25 hospitals in mainland China , Hong Kong , South Korea , Taiwan , and Vietnam , we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments .", "Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1 , life expectancy of at least 3 months , and adequate bone marrow , liver , and renal function , without other uncontrolled medical disorders .", "We randomly allocated patients ( 2:1 ; with a computer-generated unicentric randomisation list [ prepared by the study funder ] and interactive voice response system ; block size of six ; stratified by metastatic site [ single vs multiple organs ] and time from diagnosis of metastatic disease [ < 18 months vs 18 months ] ) to receive oral regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle ; patients in both groups were also to receive best supportive care .", "Participants , investigators , and the study funder were masked to treatment assignment .", "The primary endpoint was overall survival , and we analysed data on an intention-to-treat basis .", "This trial is registered with ClinicalTrials.gov , number NCT01584830 .", "Between April 29 , 2012 , and Feb 6 , 2013 , we screened 243 patients and randomly assigned 204 patients to receive either regorafenib ( 136 [ 67 % ] ) or placebo ( 68 [ 33 % ] ) .", "After a median follow-up of 74 months ( IQR 43-122 ) , overall survival was significantly better with regorafenib than it was with placebo ( hazard ratio 055 , 95 % CI 040-077 , one-sided p = 000016 ; median overall survival 88 months [ 95 % CI 73-98 ] in the regorafenib group vs 63 months [ 48-76 ] in the placebo group ) .", "Drug-related adverse events occurred in 132 ( 97 % ) of 136 regorafenib recipients and 31 ( 46 % ) of 68 placebo recipients .", "The most frequent grade 3 or higher regorafenib-related adverse events were hand-foot skin reaction ( 22 [ 16 % ] of 136 patients in the regorafenib group vs none in the placebo group ) , hypertension ( 15 [ 11 % ] vs two [ 3 % ] of 68 patients in the placebo group ) , hyperbilirubinaemia ( nine [ 7 % ] vs one [ 1 % ] ) , hypophosphataemia ( nine [ 7 % ] vs none ) , alanine aminotransferase concentration increases ( nine [ 7 % ] vs none ) , aspartate aminotransferase concentration increases ( eight [ 6 % ] vs none ) , lipase concentration increases ( six [ 4 % ] vs one [ 1 % ] ) , and maculopapular rash ( six [ 4 % ] vs none ) .", "Drug-related serious adverse events occurred in 12 ( 9 % ) patients in the regorafenib group and three ( 4 % ) in the placebo group .", "This phase 3 trial is the second to show an overall survival benefit with regorafenib compared with placebo in patients with treatment-refractory metastatic colorectal cancer , substantiating the role of regorafenib as an important treatment option for patients whose disease has progressed after standard treatments .", "In this trial , preceding standard treatments did not necessarily include targeted treatments .", "Adverse events were generally consistent with the known safety profile of regorafenib in this setting .", "Bayer HealthCare Pharmaceuticals ." ]

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

[ "Lumbar discectomy and laminectomy in patients with intervertebral disc herniation ( IDH ) is common , with variable reported reoperation rates .", "Our study examined which baseline characteristics might be risk factors for reoperation and compared outcomes between patients who underwent reoperation and those who did not .", "We performed a retrospective subgroup analysis of patients from the IDH arm of the Spine Patient Outcomes Research Trial ( SPORT ) randomized and observational cohorts .", "We analyzed baseline characteristics and outcomes of patients who underwent reoperation and those who did not with use of data collected from enrollment through eight-years of follow-up after surgery .", "Follow-up times were measured from the time of surgery , and baseline covariates were updated to the follow-up immediately preceding the time of surgery for outcomes analyses .", "At eight years , the reoperation rate was 15 % ( 691 no reoperation ; 119 reoperation ) .", "Sixty-two percent of these patients underwent reoperation because of a recurrent disc herniation ; 25 % , because of a complication or other factor ; and 11 % , because of a new condition .", "The proportion of reoperations that were performed for a recurrent disc herniation ranged from 58 % to 62 % in the individual years .", "Older patients were less likely to have reoperation ( p = 0.015 ) , as were patients presenting with asymmetric motor weakness at baseline ( p = 0.0003 ) .", "Smoking , diabetes , obesity , Workers ' Compensation , and clinical depression were not associated with a greater risk of reoperation .", "Scores on the Short Form ( SF ) -36 for bodily pain and physical functioning , the Oswestry Disability Index ( ODI ) , and the Sciatica Bothersomeness Index as well as satisfaction with symptoms had improved less at the time of follow-up in the reoperation group ( p < 0.001 ) .", "In patients who underwent surgery for IDH , the overall reoperation rate was 15 % at the eight-year follow-up .", "Patients of older age and patients presenting with asymmetric motor weakness were less likely to undergo a reoperation .", "Less improvement in patient-reported outcomes was noted in the reoperation group ." ]

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

[ "Asthma is a common disease that affects people of all ages and has significant morbidity and mortality .", "Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and care delivery methods such as shared decision making ( SDM ) into clinical practice .", "This non-blinded study will randomize 30 primary care clinics in NC stratified by four PBRNs .", "We will test dissemination across these practices using a facilitator-led participatory approach to dissemination ( FLOW ) , a novel method of participatory dissemination involving key principles of community-based participatory research , and a more typical `` lunch and learn '' dissemination method .", "Specifically , we will use cluster randomization to assign each of the 30 practices to one of three arms : ( 1 ) control , no dissemination ; ( 2 ) traditional dissemination , one didactic session a year and distribution of educational material ; and ( 3 ) FLOW dissemination .", "We hypothesize that at the unit of randomization , the clinic , patients in the FLOW dissemination arm will be more likely to share in their treatment decisions compared to patients in the traditional dissemination or control arms .", "All outcomes will be measured at the level of the clinic .", "Adoption of the SDM approach will be evaluated by 1 ) asthma exacerbations , 2 ) level of patient involvement in the decision making process , and 3 ) qualitative assessments from patients and providers .", "The trial was registered on January 27 , 2014 through the United States National Institutes of Health 's ClinicalTrials.gov NCT02047929 and funded by the Patient-Centered Outcomes Research Institute ( PCORI ) ." ]

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

[ "Adverse events ( AEs ) are health related events , reported by participants in clinical trials .", "We describe AEs in the PACE trial of treatments for chronic fatigue syndrome ( CFS ) and baseline characteristics associated with them .", "AEs were recorded on three occasions over one year in 641 participants .", "We compared the numbers and nature of AEs between treatment arms of specialist medical care ( SMC ) alone , or SMC supplemented by adaptive pacing therapy ( APT ) , cognitive behaviour therapy ( CBT ) or graded exercise therapy ( GET ) .", "We examined associations with baseline measures by binary logistic regression analyses , and compared the proportions of participants who deteriorated by clinically important amounts .", "Serious adverse events and reactions were infrequent .", "Non-serious adverse events were common ; the median ( quartiles ) number was 4 ( 2 , 8 ) per participant , with no significant differences between treatments ( P = .47 ) .", "A greater number of NSAEs were associated with recruitment centre , and baseline physical symptom count , body mass index , and depressive disorder .", "Physical function deteriorated in 39 ( 25 % ) participants after APT , 15 ( 9 % ) after CBT , 18 ( 11 % ) after GET , and 28 ( 18 % ) after SMC ( P < .001 ) , with no significant differences in worsening fatigue .", "The numbers of adverse events did not differ significantly between trial treatments , but physical deterioration occurred most often after APT .", "The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments .", "Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data ." ]

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

[ "The principal objective of the present work was to examine the effects of mind state ( mind-wandering vs. on-task ) on driving performance in a high-fidelity driving simulator .", "Mind-wandering is thought to interfere with goal-directed thought .", "It is likely , then , that when driving , mind-wandering might lead to impairments in critical aspects of driving performance .", "In two experiments , we assess the extent to which mind-wandering interferes with responsiveness to sudden events , mean velocity , and headway distance .", "Using a car-following procedure in a high-fidelity driving simulator , participants were probed at random times to indicate whether they were on-task at that moment or mind-wandering .", "The dependent measures were analyzed based on the participant 's response to the probe .", "Compared to when on-task , when mind-wandering participants showed longer response times to sudden events , drove at a higher velocity , and maintained a shorter headway distance .", "Collectively , these findings indicate that mind-wandering affects a broad range of driving responses and may therefore lead to higher crash risk .", "The results suggest that situations that are likely associated with mind-wandering ( e.g. , route familiarity ) can impair driving performance ." ]

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

[ "No study has examined the effects of the combination of respiratory muscle training ( RMT ) and abdominal drawing-in maneuver ( ADIM ) on respiratory muscle activity and function in stroke patients during early pulmonary rehabilitation .", "The purpose of this study was to investigate the effects of RMT combined with ADIM on decreased respiratory muscle activity and function in patients with post-stroke hemiplegia .", "Thirty-seven subjects with post-stroke hemiplegia were randomly allocated to three groups ; integrated training group ( ITG ) , respiratory muscle training group ( RMTG ) , and control group ( CG ) .", "All of the subjects received routine therapy for stroke rehabilitation for 1 hour , five times a week for 6 weeks .", "Especially , the ITG received RMT using an incentive respiratory spirometer and ADIM using a Stabilizer , and the RMTG only received RMT using incentive respiratory spirometer for 15 minutes a day , five times a week for 6 weeks .", "Pulmonary function was evaluated using spirometry for measuring the forced vital capacity ( FVC ) and force expiratory volume in 1 second ( FEV1 ) .", "Additional surface electromyography ( sEMG ) analysis was included by measuring the respiratory muscle activity .", "Our results showed that changes between the pre - and post-test values of FVC ( F = 12.50 , P = 0.02 ) and FEV1 ( F = 12.81 , P = 0.01 ) ( P < 0.05 ) in the ITG were significantly ( P < 0.05 ) greater .", "Changes in EMG activation of the diaphragm ( F = 13.75 , P = 0.003 ) and external intercostal ( F = 14.33 , P = 0.002 ) ( P < 0.01 ) muscles of patients in the ITG during maximal static inspiratory efforts were significantly ( P < 0.05 ) greater than those in patients of the RMTG and the CG at post-test .", "Our findings suggested that RMT combined with ADIM could improve pulmonary function in patients with post-stroke hemiplegia ." ]

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

[ "To study the effects of transcutaneous electrical nerve stimulation on multimodal analgesia after total knee arthroplasty .", "Sixty patients diagnosed as knee osteoarthritis and suffered unilateral total knee arthroplasty in the department of orthopedics , Zhejiang Traditional Chinese Medicine Hospital from March 2009 to May 2012 were randomly divided into control group and test group , 30 cases in each group .", "All the patients received celecoxib preoperatively , knee periarticular injection with the drug mixture intraoperatively , and celecoxib and morphine sulfate controlled-release tablets postoperatively .", "The patients in the test group were also treated with transcutaneous electrical nerve stimulation each day after operation .", "All the patients started doing functional exercises at 24 h after operation .", "Postoperative visual analogue scales ( VAS ) , passive and active range of motion of knee joint , and complications were recorded .", "The VAS scores of test group during postoperative 24 h to 1 week were 3.39 + / - 0.69 , 2.79 + / - 0.51 , 2.16 + / - 0.52 , and 1.07 + / - 0.57 separately , which were lower than 3.80 + / - 0.86 , 3.22 + / - 0.58 , 2.53 + / - 0.54 and 1.38 + / - 0.52 in the control group .", "The passive and active range of knee joint motion in the test group during postoperative 24 h to 2 weeks were ( 30.67 + / - 3.65 ) degrees , ( 39.17 + / - 3.96 ) degrees , ( 47.83 + / - 4.86 ) degrees , ( 93.67 + / - 7.30 ) degrees , ( 107.67 + / - 7.51 ) degrees and ( 29.83 + / - 5.33 ) degrees , ( 78.33 + / - 8.24 ) degrees , ( 95.17 + / - 5.94 ) degrees respectively , which were higher than ( 28.67 + / - 3.92 ) degrees , ( 36.83 + / - 4.25 ) degrees , ( 45.17 + / - 5.17 ) degrees , ( 89.83 + / - 7.25 ) degrees , ( 103.17 + / - 7.37 ) degrees and ( 24.17 + / - 10.26 ) degrees , ( 73.83 + / - 9.07 ) degrees , ( 91.33 + / - 7.42 ) degrees in the control group .", "In the test group , 19 patients had ring-shaped haemostasis impression to some extent in the skin of knee joint to different degree , and 5 patients had blister formation .", "It is meaningful to apply transcutaneous electrical nerve stimulation for treating multimodal analgesia after total knee arthroplasty , which can not only relieve patients ' postoperative pain , and also promote the rehabilitation of knee function as far as possible ." ]

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

[ "Current efforts to improve clinical effectiveness and utility of repetitive transcranial magnetic stimulation ( rTMS ) in the treatment of major depression ( MD ) include theta burst stimulation ( TBS ) , a patterned form of rTMS .", "Here , we investigated the efficacy of bilateral TBS to the dorsolateral prefrontal cortex ( dlPFC ) in patients with MD in additon to ongoing medication and psychotherapy .", "In this randomized-controlled trial , thirty-two patients with MD were treated for six weeks ( thirty sessions ) with either successively intermittent , activity enhancing TBS ( iTBS ) to the left and continuous , inhibiting TBS ( cTBS ) to the right dlPFC or with bilateral sham stimulation .", "Primary outcome measure was the proportion of treatment response defined as a Montgomery-sberg Depression Rating Scale ( MADRS ) 50 % compared to baseline .", "Secondary outcomes comprised response and remission rates of the Hamilton Depression Rating Scale ( HAMD ) and the Beck Depression Inventory ( BDI ) .", "A larger number of responders were found in the cTBS ( n = 9 ) compared to the sham-stimulation ( n = 4 ) group ( odds ratio : 3.86 ; Wald ( 2 ) = 3.9 , p = 0.048 ) .", "On secondary endpoint analysis , patient-reported outcome as assessed by the BDI , pointed towards a higher rate of remitters in the cTBS ( n = 6 ) than in the sham ( n = 1 ) group ( odds ratio : 9 ; Wald ( 2 ) = 3.5 , p = 0.061 ) .", "With regard to the pilot character of the study and the small sample size , the results have to be considered as preliminary .", "These findings provide first evidence that six weeks treatment of MDD with iTBS to the left and cTBS to the right dlPFC for six weeks is safe , feasible and superior to sham stimulation applied add-on to pharmacological and psychotherapeutic treatment ." ]

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

[ "The time of lung cancer screening may provide the ideal setting to discuss and initiate a smoking cessation plan that includes pharmacologic aids .", "No studies to date have fully investigated the potential effectiveness of such combined approach .", "We prospectively evaluated the biochemically verified 1-year continuous abstinence rate from smoking of 187 persistent smokers enrolled within the Multicentric Italian Lung Detection Trial ( MILD ) , who received a pharmacologic aid to quit smoking with varenicline along with behavioral counseling .", "The propensity of study subjects to succeed in smoking cessation was also monitored .", "At 12 months , the continuous abstinence rate from smoking was achieved in 37 out of 187 patients ( 19.8 % ) , with a propensity to succeed in smoking cessation for the assisted attempt equal to 1.43 , as compared to an unassisted MILD patient .", "At the end of the third month of therapy , 48.7 % of subjects showed a continuous abstinence rate , while only 33.7 % of patients were abstinent from smoking at 6 months .", "At baseline , the subgroup of MILD participants who were originally allocated to lung tomography showed higher smoking intensity than those allocated to no screening .", "A combined smoking cessation intervention can be implemented with satisfactory results within a lung cancer screening program ; this preliminary observation needs to be replicated in a prospective investigation .", "Clinicians should consider that lung cancer screening may be falsely reassuring for persistent smokers ; therefore it should always be coupled with a smoking cessation program ." ]

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

[ "To evaluate the new RetroView colonoscope and compare its ability to detect simulated polyps `` hidden '' behind colonic folds with that of a conventional colonoscope , utilizing anatomic colon models .", "Three anatomic colon models were prepared , with twelve simulated polyps `` hidden '' behind haustral folds and five placed in easily viewed locations in each model .", "Five blinded endoscopists examined two colon models in random order with the conventional or RetroView colonoscope , utilizing standard withdrawal technique .", "The third colon model was then examined with the RetroView colonoscope withdrawn initially in retroflexion and then in standard withdrawal .", "Polyp detection rates during standard and retroflexed withdrawal of the conventional and RetroView colonoscopes were determined .", "Polyp detection rates for combined standard and retroflexed withdrawal ( combination withdrawal ) with the RetroView colonoscope were also determined .", "For hidden polyps , retroflexed withdrawal using the RetroView colonoscope detected more polyps than the conventional colonoscope in standard withdrawal ( 85 % vs 12 % , P = 0.0001 ) .", "For hidden polyps , combination withdrawal with the RetroView colonoscope detected more polyps than the conventional colonoscope in standard withdrawal ( 93 % vs 12 % , P 0.0001 ) .", "The RetroView colonoscope in `` combination withdrawal '' was superior to other methods in detecting all ( hidden + easily visible ) polyps , with successful detection of 80 of 85 polyps ( 94 % ) compared to 28 ( 32 % ) polyps detected by the conventional colonoscope in standard withdrawal ( P < 0.0001 ) and 67 ( 79 % ) polyps detected by the RetroView colonoscope in retroflexed withdrawal alone ( P < 0.01 ) .", "Continuous withdrawal of the colonoscope through the colon model while retroflexed was achieved by all endoscopists .", "In a post-test survey , four out of five colonoscopists reported that manipulation of the colonoscope was easy or very easy .", "In simulated testing , the RetroView colonoscope increased detection of hidden polyps .", "Combining standard withdrawal with retroflexed withdrawal may become the new paradigm for `` complete screening colonoscopy '' ." ]

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

[ "Parents of children and adolescents with diabetes type 1 ( DT1 ) usually experience high stress levels , as they have to cope with multiple demands in their everyday life .", "Different complex interventions have been implemented , which sometimes have led to opposite results .", "The purpose of this study was to assess stress levels in parents of children and adolescents with DT1 and to evaluate the effectiveness of a stress management program ( progressive muscle relaxation combined with diaphragmatic breathing ) in reducing perceived and parenting stress , increasing internal locus of control , promoting healthy lifestyle , and normalizing cortisol levels .", "Randomized controlled trial .", "A total of 44 parents were randomly assigned to the intervention group ( performing relaxation for eight weeks , n = 19 ) and control group ( n = 25 ) .", "Pre-post measurements included cortisol levels , lifestyle characteristics , perceived stress , perception of health , and parenting stress .", "A statistically significant decrease in perceived stress ( from 27.21 to 19.00 , P = .001 ) , as well as in parenting stress ( from 85.79 to 73.68 , P = .003 ) , was observed in the intervention group .", "A statistically significant difference was found in perceived stress between the two groups after the intervention ( Dmean = 6.64 , P = .010 ) .", "No significant difference was revealed between or within the groups in cortisol levels .", "Significant improvement was reported by the subjects of the intervention group in various lifestyle parameters .", "Relaxation techniques seem to have a positive impact on stress and on various lifestyle factors in parents of children and adolescents with DT1 .", "Future research on long-term benefits of an intervention program comprising of various relaxation schemes is warranted ." ]

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

[ "Consumption of a cholesterol lowering dietary portfolio including plant sterols ( PS ) , viscous fibre , soy proteins and nuts for 6 months improves blood lipid profile .", "Plant sterols reduce blood cholesterol by inhibiting intestinal cholesterol absorption and concerns have been raised whether PS consumption reduces fat soluble vitamin absorption .", "The objective was to determine effects of consumption of a cholesterol lowering dietary portfolio on circulating concentrations of PS and fat soluble vitamins .", "Using a parallel design study , 351 hyperlipidemic participants from 4 centres across Canada were randomized to 1 of 3 groups .", "Participants followed dietary advice with control or portfolio diet .", "Participants on routine and intensive portfolio involved 2 and 7 clinic visits , respectively , over 6 months .", "No changes in plasma concentrations of and tocopherol , lutein , lycopene and retinol , but decreased - carotene concentrations were observed with intensive ( week 12 : p = 0.045 ; week 24 : p = 0.039 ) and routine ( week 12 : p = 0.031 ; week 24 : p = 0.078 ) portfolio groups compared to control .", "However , cholesterol adjusted - carotene and fat soluble compound concentrations were not different compared to control .", "Plasma PS concentrations were increased with intensive ( campesterol :p = 0.012 ; - sitosterol :p = 0.035 ) and routine ( campesterol : p = 0.034 ; - sitosterol : p = 0.080 ) portfolio groups compared to control .", "Plasma cholesterol-adjusted campesterol and - sitosterol concentrations were negatively correlated ( p < 0.001 ) with total and LDL-C levels .", "Results demonstrate that consuming a portfolio diet reduces serum total and LDL-C levels while increasing PS values , without altering fat soluble compounds concentrations .", "The extent of increments of PS with the current study are not deleterious and also maintaining optimum levels of fat soluble vitamins are of paramount necessity to maintain overall metabolism and health .", "Results indicate portfolio diet as one of the best options for CVD risk reduction .", "clinicaltrials.gov Identifier : NCT00438425 ." ]

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

[ "To better understand the role of the professional oral health care for elderly in improving geriatric oral health , the effects of short-term professional oral health care ( once per week for 1 month ) on oral microbiological parameters were assessed .", "Parallel , open-labelled , randomize-controlled trial was undertaken in a nursing home for elderly in Shizuoka , Japan .", "Thirty-four dentate elderly over 74 years were randomly assigned from ID number to the intervention ( 17/34 ) and control ( 17/34 ) groups .", "The outcomes were changes in oral microbiological parameters ( number of bacteria in unstimulated saliva ; whole bacteria , Streptococcus , Fusobacterium and Prevotella : opportunistic pathogens detection : and index of oral hygiene evaluation [ Dental Plaque Index , DPI ] ) within the intervention period .", "Each parameter was evaluated at before and after intervention period .", "Four elderly were lost from mortality ( 1 ) , bone fracture ( 1 ) , refused to participate ( 1 ) and multi-antibiotics usage ( 1 ) .", "Finally , 30 elderly were analysed ( 14/intervention and 16/control ) .", "At baseline , no difference was found between the control and intervention groups .", "After the intervention period , the percentage of Streptococcus species increased significantly in the intervention group ( Intervention , 86 % [ 12/14 ] ; Control , 50 % [ 8/16 ] : Fisher 's , right-tailed , P < 0.05 ) .", "Moreover , DPI significantly improved in the intervention group ( Intervention , 57 % [ 8/14 ] ; Control , 13 % [ 2/16 ] : Fisher 's , two-tailed , P < 0.05 ) .", "The improvement in DPI extended for 3 months after intervention .", "None of side effects were reported .", "The short-term professional oral health care can improve oral conditions in the elderly ." ]

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

[ "Physical activity guidelines recommend engaging in moderate - and vigorous-intensity physical activity to elicit health benefits .", "Similarly , these higher intensity ranges for activity are typically targeted in healthy living interventions ( ie , exercise prescription ) .", "Comparatively less attention has been focused on changing lower intensity physical activity ( ie , sedentary activity ) behaviors .", "The purpose of this study was to explore the effects of prescribing changes to physical activity of various intensities ( ie , sedentary through exercise ) through the primary care setting .", "Sixty older adults ( aged 55-75 years ; mean age 63 = 5 years ) volunteered to participate , and were randomly assigned to 4 groups : 3 receiving an activity prescription intervention targeting a specific intensity of physical activity ( exercise , sedentary , or both ) , and 1 control group .", "During the 12-week intervention period participants followed personalized activity programs at home .", "Basic clinical measures ( anthropometrics , blood pressure , aerobic fitness ) and blood panel for assessing cardiometabolic risk ( glucose , lipid profile ) were conducted at baseline ( week 0 ) and follow-up ( week 12 ) in a primary care office .", "There were no differences between groups at baseline ( P > 0.05 ) .", "The intervention changed clinical ( F , = 20.458 , P = 0.000 , P = 0.672 ) and blood panel measures ( F , = 4.576 , P = 0.002 , P = 0.314 ) of cardiometabolic health .", "Post hoc analyses indicted no differences between groups ( P > 0.05 ) .", "Physical activity prescription of various intensities through the primary care setting improved cardiometabolic health status .", "To our knowledge , this is the first report of sedentary behavior prescription ( alone , or combined with exercise ) in primary care .", "The findings support the ongoing practice of fitness assessment and physical activity prescription for chronic disease management and prevention ." ]

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

[ "`` Practice effects '' ( PE ) , or performance improvements due to prior exposure to testing , are known to confound cognitive test results , particularly when short intervals occur between two test sessions .", "We examined two subsamples with short or long re-test intervals from a recent clinical trial .", "Thirty-four non-depressed adults with mild Huntington Disease ( HD ) participated .", "Three cognitive tests were administered at screening and again at baseline , before active treatment randomization .", "Half the sample had a 24-hour retest interval while the other half was > 6-days .", "The two groups differed on demographic/clinical factors ( age , Total Motor Score and Total Functional Capacity ) .", "After controlling for age and motor score , PE differences were found on three of the five UHDRS cognitive tests : the longer interval group showed larger PE on Symbol-Digit Modalities and Stroop color , while the rapid interval group had larger PE on Stroop interference .", "Controlling for screening cognitive performance yielded similar results .", "Length of interval between screening and baseline visits and level of disease severity may influence stability of UHDRS cognitive test results in clinical trials in HD ." ]

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

[ "There is increasing evidence that vaccines have an effect on general mortality which goes beyond specific disease protection .", "Oral polio vaccine ( OPV ) is widely used in low-income countries , but in observational studies in Guinea-Bissau we observed that not receiving OPV at birth was associated with reduced overall male infant mortality and enhanced immune response to BCG vaccine .", "We therefore initiated a randomized trial to test the overall effect of OPV at birth ( OPV0 ) .", "A small thymic gland is a predictor of mortality in high-mortality settings .", "Within the trial we aimed to test whether no-OPV0 was associated with increased thymic size .", "In 511 normal birth weight infants who were randomized to receive or not receive OPV0 , thymic index and thymus/weight index were measured before randomization and after 2 weeks ( N = 49 ) , 4 weeks ( N = 308 ) or 6 weeks ( N = 27 ) .", "The association between OPV0 and the log transformed thymic size indicators were analyzed in ANCOVA models with thymic size at follow-up as the outcome and adjusting for thymic size at enrollment and age at follow-up .", "Estimates were reported as geometric mean ratios ( GMR ) with 95 % confidence intervals , comparing no-OPV0 to OPV0 .", "No-OPV0 was not associated with thymic index after 2 weeks ( GMR : 1.14 ( 0.99-1 .30 ) ) , after 4 weeks ( GMR : 0.98 ( 0.93-1 .05 ) ) or after 6 weeks ( GMR : 1.00 ( 0.81-1 .23 ) ) .", "However , no-OPV0 was associated with increased thymus/weight index after 2 weeks ( GMR : 1.22 ( 1.06-1 .40 ) ) , but the effect was not seen after 4 weeks ( GMR : 0.97 ( 0.92-1 .03 ) ) and 6 weeks ( GMR : 0.99 ( 0.82-1 .19 ) ) .", "There were no strong sex-differences .", "Overall there was no effect on thymic size of OPV0 when administered with BCG .", "The results could indicate that if an effect occurs , it is only within the first weeks after vaccination ." ]

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

[ "This study investigated the influence of injury cause , contact-sport participation , and prior knowledge of mild traumatic brain injury ( mTBI ) on injury beliefs and chronic symptom expectations of mTBI .", "A total of 185 non-contact-sport players ( non-CSPs ) and 59 contact-sport players ( CSPs ) with no history of mTBI were randomly allocated to one of two conditions in which they read either a vignette depicting a sport-related mTBI ( mTBIsport ) or a motor-vehicle-accident-related mTBI ( mTBIMVA ) .", "The vignettes were otherwise standardized to convey the same injury parameters ( e.g. , duration of loss of consciousness ) .", "After reading a vignette , participants reported their injury beliefs ( i.e. , perceptions of injury undesirability , chronicity , and consequences ) and their expectations of chronic postconcussion syndrome ( PCS ) and posttraumatic stress disorder ( PTSD ) symptoms .", "Non-CSPs held significantly more negative beliefs and expected greater PTSD symptomatology and greater PCS affective symptomatology from an mTBIMVA vignette thann mTBIsport vignette , but this difference was not found for CSPs .", "Unlike CSPs , non-CSPs who personally knew someone who had sustained an mTBI expected significantly less PCS symptomatology than those who did not .", "Despite these different results for non-CSPs and CSPs , overall , contact-sport participation did not significantly affect injury beliefs and symptom expectations from an mTBIsport .", "Expectations of persistent problems after an mTBI are influenced by factors such as injury cause even when injury parameters are held constant .", "Personal knowledge of mTBI , but not contact sport participation , may account for some variability in mTBI beliefs and expectations .", "These factors require consideration when assessing mTBI outcome ." ]

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

[ "Previous research has demonstrated that current methods of informed consent are relatively ineffective as shown by poor recall and comprehension by adolescent patients and their parents .", "The purpose of this study was to determine whether adding a short videotape presentation reiterating the issues related to informed consent to a modified informed consent document that emphasizes a limited number of core and patient-specific custom `` chunks '' at the beginning of an informed consent presentation improved the recall and comprehension of the risks , benefits , and alternatives of orthodontic treatment .", "A second objective was to evaluate the current related data for recommendable practices .", "Seventy patient-parent pairs were randomly divided into 2 groups .", "The intervention group ( group A ) patients and parents together reviewed a customized slide show and a short videotape presentation describing the key risks of orthodontic treatment .", "Group B followed the same protocol without viewing the videotape .", "All patients and parents were interviewed independently by research assistants using an established measurement tool with open-ended questions .", "Interviews were transcribed and scored for the appropriateness of responses using a previously established codebook .", "Lastly , the patients and parents were given 2 reading literacy tests , 1 related to health and 1 with general content followed by the self-administered demographic and psychological state questionnaires .", "There were no significant differences between the groups for sociodemographic variables .", "There were no significant differences between the groups for overall recall and comprehension ; recall and comprehension for the domains of treatment , risk , and responsibility ; and recall and comprehension for core , general , and custom items .", "The positional effects were limited in impact .", "When compared with previous studies , these data further demonstrate the benefit of improved readability and audiovisual supplementation with the addition of `` chunking . ''", "There is no benefit to adding a short video to the previously established improved readability and audiovisual supplementation .", "There is a significant benefit of improved readability and audiovisual slide supplementation with the addition of `` chunking '' over traditional informed consent methods in terms of patient improvement in overall comprehension , treatment recall , and treatment comprehension .", "The treatment domain is the most affected ." ]

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

[ "War-related trauma , posttraumatic stress disorder ( PTSD ) , depression and suicide are common in US military members .", "Often , those affected do not seek treatment due to stigma and barriers to care .", "When care is sought , it often fails to meet quality standards .", "A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system .", "The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care .", "The STEPS-UP Trial ( STepped Enhancement of PTSD Services Using Primary Care ) is a 6 installation ( 18 clinic ) randomized effectiveness trial in the US military health system .", "Study rationale , design , enrollment and sample characteristics are summarized .", "Military members attending primary care with suspected PTSD , depression or both were referred to care management and recruited for the trial ( 2592 ) , and 1041 gave permission to contact for research participation .", "Of those , 666 ( 64 % ) met eligibility criteria , completed baseline assessments , and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care .", "Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP .", "Research reassessments occurred at 3 - , 6 - , and 12-months .", "Baseline characteristics were similar across the two intervention groups .", "STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system , assessing how an implementation model affects collaborative care impact on mental health outcomes .", "It promises lessons for health system change ." ]

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

[ "Survival is poorer in elderly patients with head and neck squamous cell carcinomas [ HNSCCs ] than in younger patients .", "Possible explanations include a contribution of co-morbidities to mortality , frequent refusal of standard therapy , and the use of suboptimal treatments due to concern about toxicities .", "The Comprehensive Geriatric Assessment [ CGA ] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans .", "The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer .", "Our aim here was to assess the impact of the CGA on overall survival , function , and nutritional status of elderly patients with HNSCC .", "EGeSOR is an open-label , multicentre , randomised , controlled , parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC .", "The intervention includes four components : the CGA conducted by a geriatrician before cancer treatment , participation of the same geriatrician in cancer treatment selection , a standardised geriatric therapeutic intervention designed by the same geriatrician ; and geriatric follow-up for 24 months .", "The primary endpoint , assessed after 6 months , is a composite criterion including death , functional impairment [ Activities of Daily Living score decrease 2 ] , and weight loss 10 % .", "Secondary endpoints include progression-free survival , unscheduled admissions , quality of life , treatment toxicities , costs , and completion of the planned cancer treatment .", "A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre , age , T and N stages , and tumour site [ oral , oropharyngeal , hypopharyngeal , or laryngeal ] .", "The estimated sample size is 704 patients , who are being recruited by 14 centres in 9 French cities .", "EGeSOR is the first randomised trial of the CGA in elderly cancer patients .", "We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC .", "If this expectation is fulfilled , the trial may lead to modifications of the management model for elderly patients with cancer .", "Trial registration : NCT02025062 ." ]

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

[ "Laparoscopic ventral hernia repair ( LVHR ) is associated with considerable postoperative pain .", "Transversus abdominis plane ( TAP ) blocks have proven effective in controlling postoperative pain in a variety of laparoscopic abdominal operations .", "To date , no studies have focused on TAP blocks in LVHR .", "Our goal was to assess whether TAP blocks reduce opioid requirements and pain scores after LVHR .", "Patients undergoing LVHR were randomly assigned to receive a TAP block or placebo injection .", "The primary end points were cumulative opioid use at 1 , 3 , 6 , 12 , 18 , and 24 hours postoperatively and pain scores recorded at 1 and 24 hours postoperatively .", "Patients in the experimental TAP group ( n = 52 ) and control group ( n = 48 ) were comparable with respect to patient demographics and clinical characteristics .", "In the postanesthesia care unit , the TAP group had significantly lower pain scores than the control group ( p < 0.05 ) .", "Patients in the TAP group used less opioids than the control group at each time point assessed after 6 hours postoperatively ( p < 0.05 ) .", "There was no significant difference in pain scores at 24 hours postoperatively ( p > 0.05 ) .", "Transversus abdominis plane blocks given during LVHR significantly decrease both short-term postoperative opioid use and pain experienced by patients ." ]

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

[ "Research conducted with adults suggests that successful weight losers demonstrate greater activation in brain regions associated with executive control in response to viewing high-energy foods .", "No previous studies have examined these associations in adolescents .", "Functional neuroimaging was used to assess brain response to food images among groups of overweight ( OW ) , normal-weight ( NW ) , and successful weight-losing ( SWL ) adolescents .", "Eleven SWL , 12 NW , and 11 OW participants underwent functional magnetic resonance imaging while viewing images of high - and low-energy foods .", "When viewing high-energy food images , SWLs demonstrated greater activation in the dorsolateral prefrontal cortex ( DLPFC ) compared with OW and NW controls .", "Compared with NW and SWL groups , OW individuals demonstrated greater activation in the ventral striatum and anterior cingulate in response to food images .", "Adolescent SWLs demonstrated greater neural activation in the DLPFC compared with OW/NW controls when viewing high-energy food stimuli , which may indicate enhanced executive control .", "OW individuals ' brain responses to food stimuli may indicate greater reward incentive processes than either SWL or NW groups ." ]

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

[ "The integration of simulation into the training of health care professionals provides context for decision making and procedural skills in a high-fidelity environment , without risk to actual patients .", "It was hypothesised that a novel approach to simulation-based education - error management training - would produce higher performance ratings compared with traditional step-by-step instruction .", "Radiology technology students were randomly assigned to participate in traditional procedural-based instruction ( n = 11 ) or vicarious error management training ( n = 11 ) .", "All watched an instructional video and discussed how well each incident was handled ( traditional instruction group ) or identified where the errors were made ( vicarious error management training ) .", "Students then participated in a 30-minute case-based simulation .", "Simulations were videotaped for performance analysis .", "Blinded experts evaluated performance using a predefined evaluation tool created specifically for the scenario .", "Blinded experts evaluated performance using a predefined evaluation toolcreated specifically for the scenario", "The vicarious error management group scored higher on observer-rated performance ( Mean = 9.49 ) than students in the traditional instruction group ( Mean = 9.02 ; p < 0.01 ) .", "These findings suggest that incorporating the discussion of errors and how to handle errors during the learning session will better equip students when performing hands-on procedures and skills .", "This pilot study provides preliminary evidence for integrating error management skills into medical curricula and for the design of learning goals in simulation-based education ." ]

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

[ "Dry eye is a multifactorial disease of the tears and the ocular surface .", "This study aimed to investigate the clinical efficacy of a non-steroidal anti-inflammatory drug , pranoprofen , in the treatment of dry eye .", "It is a prospective , multi-center , randomized , controlled , parallel group study .", "One hundred and fifteen patients with mild to moderate dry eye disease ( 55-60 in each treatment group ) participated in this multi-center study .", "Patients were randomly administered with eyedrops containing 0.1 % pranoprofen ( PRA ) plus 0.1 % sodium hyaluronate ( SH ) or SH only , three times daily for 28 days , followed by a 1-week after treatment observation .", "Dry eye symptom score ( DESS ) , fluorescein corneal staining ( FLCS ) , tear break-up time ( TBUT ) , and Shirmer 1 tear test ( ST1 , without anesthesia ) were evaluated or conducted before treatment and at each study visit .", "Conjunctival impression cytology was taken from the patients treated with PRA plus SH before and after treatment and real-time polymerase chain reaction ( RT-PCR ) was performed to detect the changes of human leukocyte antigen DR ( HLA-DR ) and intercellular adhesion molecule 1 ( ICAM-1 ) .", "Patients treated with PRA plus SH showed gradual improvements of DESS , FLCS , and TBUT .", "Between-group comparisons of FLCS and TBUT have statistically significant differences from day 14 .", "Good tolerance with no severe adverse events was found in both groups .", "Patients treated with PRA plus SH had a reduced expression level of HLA-DR and were statistically different after 28 days of therapy .", "The application of PRA at a dose of 0.1 % was well tolerated and benefited to the patients with mild to moderate dry eye disease .", "The underlying mechanism of its efficacy may be associated with the reduction of inflammatory factors of conjunctival epithelial cells ." ]

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

[ "We investigated the pattern of rash , diarrhea , and hepatic adverse events ( AEs ) secondary to lapatinib and their association with age and pathologic complete response ( pCR ) in the Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation ( NeoALLTO ) phase III trial .", "Patients with HER2-positive early breast cancer were randomly assigned to receive lapatinib ( Arm A ) , trastuzumab ( Arm B ) , or their combination ( Arm C ) for 6 weeks followed by the addition of paclitaxel for 12 weeks before surgery .", "We investigated the frequency and time to developing each AE according to age ( 50 v > 50 years ) and their association with pCR in a logistic regression model adjusted for age , hormone receptors , tumor size , nodal status , planned breast surgery , completion of lapatinib administration , and treatment arm .", "Only patients randomly assigned to arms A and C were eligible ( n = 306 ) .", "Younger patients ( 50 years ) experienced significantly more rash compared with older patients ( 74.4 % v 47.9 % ; P < .0001 ) .", "Diarrhea and hepatic AEs were observed in 78.8 % and 41.2 % of patients , respectively , with no differences in rate or severity or time of onset according to age .", "Early rash ( ie , before starting paclitaxel ) was independently associated with a higher chance of pCR , mainly in patients older than 50 years ( odds ratio [ OR ] = 3.76 ; 95 % CI , 1.69 to 8.34 ) but not in those 50 years ( OR = 0.92 ; 95 % CI , 0.45 to 1.88 ; P for interaction = .01 ) .", "No significant association was observed between pCR and diarrhea or hepatic AEs .", "Our results indicate that the frequency and clinical relevance of lapatinib-related rash is largely dependent on patient age ." ]

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

[ "We examined whether the effects of topiramate and a single nucleotide polymorphism ( rs2832407 ) in GRIK1 , which encodes a kainate receptor subunit , persisted following a 12-week , placebo-controlled trial in 138 heavy drinkers with a treatment goal of reduced drinking .", "During treatment , topiramate 200mg/d significantly reduced heavy drinking days and increased the frequency of abstinent days ( Am J Psychiatry , 2014 , 171:445 ) .", "In the European-American ( EA ) subsample ( n = 122 ) , rs2832407 moderated the treatment effect on heavy drinking .", "Patients were re-interviewed 3 and 6months after the end of treatment .", "During treatment , we obtained 92.4 % of drinking data , with 89.1 and 85.5 % complete data at the 3 - and 6-month follow-up visits , respectively .", "We examined 4 outcomes over time in the overall sample and the EA subsample : percent heavy drinking days ( PHDD ) , percent days abstinent ( PDA ) , serum - glutamyl transpeptidase ( GGTP ) concentration , and a measure of alcohol-related problems .", "In the full sample , the lower PHDD and higher PDA seen with topiramate treatment were no longer significant during follow-up .", "Nonetheless , the topiramate-treated patients had lower alcohol-related problem scores during treatment and both follow-up periods .", "Further , in the EA subsample , the greater reduction in PHDD seen with topiramate treatment in rs2832407 * C-allele homozygotes persisted throughout follow-up , with no significant effects in A-allele carriers .", "A reduction in GGTP concentration was consistent with the reduction in heavy drinking , but did not reach statistical significance .", "There are persistent therapeutic effects of topiramate in heavy drinkers , principally in rs2832407 * C-allele homozygotes ." ]

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

[ "We introduce a new method of peritoneal dialysis ( PD ) catheter placement with cystoscopic assistance .", "It has clear advantages compared with conventional open surgery .", "Patients with end-stage renal disease ( ESRD ) were randomly divided into two groups .", "Group A ( 14 patients ) underwent cystoscopy-assisted surgery , and group B ( 15 patients ) underwent conventional open surgery for the PD catheter placement .", "Continuous ambulatory PD training was started 14 days after surgery in both groups .", "We evaluated the differences between the two groups prospectively .", "Both groups had no difference in demographics including age , male/female ratio , previous abdominal surgery percent , and cause of ESRD ( p > 0.05 ) .", "All catheters were placed successfully without mortality .", "Group A had better surgery-related data : local anesthesia rate , VAS ( Visual Analogue Score ) , incisional length , and hospital stay were significantly different compared with group B ( p < 0.05 ) .", "And the blood loss duration surgery and duration of surgery were not significantly different ( p > 0.05 ) .", "In group A , there was no case of catheter obstruction and migration , dialysate leak , exit site infection , or incisional hernia .", "There was only one peritonitis case in group A. Compared with group B , the total surgical complications difference was significant ( p < 0.05 ) .", "Cystoscopy-assisted PD catheter placement is a direct , visual , safe , precise , easy , inexpensive , and minimally invasive technique that is ideal for patients with ESRD ." ]

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

[ "The optimum duration of first-line treatment with chemotherapy in combination with bevacizumab in patients with metastatic colorectal cancer is unknown .", "The CAIRO3 study was designed to determine the efficacy of maintenance treatment with capecitabine plus bevacizumab versus observation .", "In this open-label , phase 3 , randomised controlled trial , we recruited patients in 64 hospitals in the Netherlands .", "We included patients older than 18 years with previously untreated metastatic colorectal cancer , with stable disease or better after induction treatment with six 3-weekly cycles of capecitabine , oxaliplatin , and bevacizumab ( CAPOX-B ) , WHO performance status of 0 or 1 , and adequate bone marrow , liver , and renal function .", "Patients were randomly assigned ( 1:1 ) to either maintenance treatment with capecitabine and bevacizumab ( maintenance group ) or observation ( observation group ) .", "Randomisation was done centrally by minimisation , with stratification according to previous adjuvant chemotherapy , response to induction treatment , WHO performance status , serum lactate dehydrogenase concentration , and treatment centre .", "Both patients and investigators were aware of treatment assignment .", "We assessed disease status every 9 weeks .", "On first progression ( defined as PFS1 ) , patients in both groups were to receive the induction regimen of CAPOX-B until second progression ( PFS2 ) , which was the study 's primary endpoint .", "All endpoints were calculated from the time of randomisation .", "Analyses were done by intention to treat .", "This trial is registered with ClinicalTrials.gov , number NCT00442637 .", "Between May 30 , 2007 , and Oct 15 , 2012 , we randomly assigned 558 patients to either the maintenance group ( n = 279 ) or the observation group ( n = 279 ) .", "Median follow-up was 48 months ( IQR 36-57 ) .", "The primary endpoint of median PFS2 was significantly improved in patients on maintenance treatment , and was 85 months in the observation group and 117 months in the maintenance group ( HR 067 , 95 % CI 056-081 , p < 00001 ) .", "This difference remained significant when any treatment after PFS1 was considered .", "Maintenance treatment was well tolerated , although the incidence of hand-foot syndrome was increased ( 64 [ 23 % ] patients with hand-foot skin reaction during maintenance ) .", "The global quality of life did not deteriorate during maintenance treatment and was clinically not different between treatment groups .", "Maintenance treatment with capecitabine plus bevacizumab after six cycles of CAPOX-B in patients with metastatic colorectal cancer is effective and does not compromise quality of life .", "Dutch Colorectal Cancer Group ( DCCG ) .", "The DCCG received financial support for the study from the Commissie Klinische Studies ( CKS ) of the Dutch Cancer Foundation ( KWF ) , Roche , and Sanofi-Aventis ." ]

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

[ "Self-guided , Web-based interventions for depression show promising results but suffer from high attrition and low user engagement .", "Online peer support networks can be highly engaging , but they show mixed results and lack evidence-based content .", "Our aim was to introduce and evaluate a novel Web-based , peer-to-peer cognitive reappraisal platform designed to promote evidence-based techniques , with the hypotheses that ( 1 ) repeated use of the platform increases reappraisal and reduces depression and ( 2 ) that the social , crowdsourced interactions enhance engagement .", "Participants aged 18-35 were recruited online and were randomly assigned to the treatment group , `` Panoply '' ( n = 84 ) , or an active control group , online expressive writing ( n = 82 ) .", "Both are fully automated Web-based platforms .", "Participants were asked to use their assigned platform for a minimum of 25 minutes per week for 3 weeks .", "Both platforms involved posting descriptions of stressful thoughts and situations .", "Participants on the Panoply platform additionally received crowdsourced reappraisal support immediately after submitting a post ( median response time = 9 minutes ) .", "Panoply participants could also practice reappraising stressful situations submitted by other users .", "Online questionnaires administered at baseline and 3 weeks assessed depression symptoms , reappraisal , and perseverative thinking .", "Engagement was assessed through self-report measures , session data , and activity levels .", "The Panoply platform produced significant improvements from pre to post for depression ( P = .001 ) , reappraisal ( P < .001 ) , and perseverative thinking ( P < .001 ) .", "The expressive writing platform yielded significant pre to post improvements for depression ( P = .02 ) and perseverative thinking ( P < .001 ) , but not reappraisal ( P = .45 ) .", "The two groups did not diverge significantly at post-test on measures of depression or perseverative thinking , though Panoply users had significantly higher reappraisal scores ( P = .02 ) than expressive writing .", "We also found significant group by treatment interactions .", "Individuals with elevated depression symptoms showed greater comparative benefit from Panoply for depression ( P = .02 ) and perseverative thinking ( P = .008 ) .", "Individuals with baseline reappraisal deficits showed greater comparative benefit from Panoply for depression ( P = .002 ) and perseverative thinking ( P = .002 ) .", "Changes in reappraisal mediated the effects of Panoply , but not the expressive writing platform , for both outcomes of depression ( ab = -1.04 , SE 0.58 , 95 % CI -2.67 to -.12 ) and perseverative thinking ( ab = -1.02 , SE 0.61 , 95 % CI -2.88 to -.20 ) .", "Dropout rates were similar for the two platforms ; however , Panoply yielded significantly more usage activity ( P < .001 ) and significantly greater user experience scores ( P < .001 ) .", "Panoply engaged its users and was especially helpful for depressed individuals and for those who might ordinarily underutilize reappraisal techniques .", "Further investigation is needed to examine the long-term effects of such a platform and whether the benefits generalize to a more diverse population of users .", "ClinicalTrials.gov NCT02302248 ; https://clinicaltrials.gov/ct2/show/NCT02302248 ( Archived by WebCite at http://www.webcitation.org/6Wtkj6CXU ) ." ]

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

[ "To improve patient health , recent research urges for medical decision aids that are designed to enhance the effectiveness of specific medically related decisions .", "Many such decisions involve complex information , and decision aids that independently use deliberative ( analytical and slower ) or intuitive ( more affective and automatic ) cognitive processes for such decisions result in suboptimal decisions .", "Unconscious thought can arguably use both intuitive and deliberative ( slow and analytic ) processes , and this combination may further benefit complex patient ( or practitioner ) decisions as medical decision aids .", "Indeed , mounting research demonstrates that individuals render better decisions generally if they are distracted from thinking consciously about complex information after it is presented ( but can think unconsciously ) , relative to thinking about that information consciously or not at all .", "The current research tested whether the benefits of unconscious thought processes can be replicated using an Internet platform for a patient medical decision involving complex information .", "This research also explored the possibility that judgments reported after a period of unconscious thought are actually the result of a short period of conscious deliberation occurring during the decision report phase .", "A total of 173 participants in a Web-based experiment received information about four medical treatments , the best ( worst ) associated with mostly positive ( negative ) side-effects/attributes and the others with equal positive-negative ratios .", "Next , participants were either distracted for 3 minutes ( unconscious thought ) , instructed to think about the information for 3 minutes ( conscious thought ) , or moved directly to the decision task ( immediate decision ) .", "Finally , participants reported their choice of , and attitudes toward , the treatments while experiencing high , low , or no cognitive load , which varied their ability to think consciously while reporting judgments .", "Cognitive load was manipulated by having participants memorize semi-random ( high ) , line structured ( low ) , or no dot patterns and recall these intermittently with their decision reports .", "Overall then , participants were randomly assigned to the conditions of a 3 ( thought condition ) by 3 ( cognitive-load level ) between-subjects design .", "A logistic regression analysis indicated that the odds of participants choosing the best treatment were 2.25 times higher in the unconscious-thought condition compared to the immediate-decision condition ( b = .81 , Wald = 4.32 , P = .04 , 95 % CI 1.048-4 .836 ) , and 2.39 times greater compared to the conscious-thought condition ( b = .87 , Wald = 4.87 , P = .027 , 95 % CI 1.103-5 .186 ) .", "No difference was observed between the conscious-thought condition compared to the immediate-decision condition , and cognitive load manipulations did not affect choices or alter the above finding .", "This research demonstrates a plausible benefit of unconscious thinking as a decision aid for complex medical decisions , and represents the first use of unconscious thought processes as a patient-centered medical decision aid .", "Further , the quality of decisions reached unconsciously does not appear to be affected by the amount of cognitive load participants experienced ." ]

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

[ "the medications used according to the recommendation of the World Health Organization do not promote pain relief in a number of patients with cancer pain .", "The aim of this study was to evaluate the use of morphine as first medication for the treatment of moderate cancer pain in patients with advanced and/or metastatic disease , as an option to the recommendations of the World Health Organization analgesic ladder .", "sixty patients without opioid therapy , with 18 years of age , were randomized into two groups .", "G1 patients received medication according to the analgesic ladder and started treatment with non-opioids in the first , weak opioids in the second , and strong opioids in the third step ; G2 patients received morphine as first analgesic medication .", "The efficacy and tolerability of initial use of morphine were evaluated every two weeks for three months .", "the groups were similar with respect to demographic data .", "There was no significant difference between the groups regarding pain intensity , quality of life , physical capacity , satisfaction with treatment , need for complementation and dose of morphine .", "In G1 there was a higher incidence of nausea ( p = 0.0088 ) , drowsiness ( p = 0.0005 ) , constipation ( p = 0.0071 ) and dizziness ( p = 0.0376 ) in the second visit and drowsiness ( p = 0.05 ) in the third .", "the use of morphine as first medication for pain treatment did not promote better analgesic effect than the ladder recommended by World Health Organization , with higher incidence of adverse effects ." ]

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

[ "Simplification of antiretroviral therapy in patients with suppressed viremia may minimize long-term adverse effects .", "The study 's primary objective was to determine whether abacavir/lamivudine + atazanavir ( ABC/3TC + ATV ) was virologically non-inferior to tenofovir/emtricitabine + atazanavir/ritonavir ( TDF/FTC + ATV/r ) over 24 weeks in a population of virologically suppressed , HIV-1 infected patients .", "This open-label , multicenter , non-inferiority study enrolled antiretroviral experienced , HIV-infected adults currently receiving a regimen of TDF/FTC + ATV/r for 6 months with no history of virologic failure and whose HIV-1 RNA had been 75 copies/mL on 2 consecutive measurements including screening .", "Patients were randomized 1 2 to continue current treatment or simplify to ABC/3TC + ATV .", "The primary endpoint was the proportion of patients with HIV-RNA < 50 copies/mL at Week 24 by the Time to Loss of Virologic Response ( TLOVR ) algorithm .", "Secondary endpoints included alternative measures of efficacy , adverse events ( AEs ) , and fasting lipids .", "Exploratory endpoints included inflammatory , coagulation , bone , and renal biomarkers .", "After 24 weeks , ABC/3TC + ATV ( n = 199 ) was non-inferior to TDF/FTC + ATV/r ( n = 97 ) by both the primary analysis ( 87 % in both groups ) and all secondary efficacy analyses .", "Rates of grade 2-4 AEs were similar between the two groups ( 40 % vs 37 % , respectively ) , but an excess of hyperbilirubinemia made the rate of grade 3-4 laboratory abnormalities higher in the TDF/FTC + ATV/r group ( 30 % ) compared with the ABC/3TC + ATV group ( 13 % ) .", "Lipid levels were stable except for HDL cholesterol , which increased significantly in the ABC/3TC + ATV group .", "Bone and renal biomarkers improved significantly between baseline and Week 24 in patients taking ABC/3TC + ATV , and the difference between groups was significant at Week 24 .", "No significant changes occurred in any inflammatory or coagulation biomarker within or between treatment groups .", "After 24 weeks , simplification to ABC/3TC + ATV from TDF/FTC + ATV/r maintained viral suppression was well-tolerated , and led to improvements in bone and renal biomarkers and HDL cholesterol .", "ClinicalTrials.gov NCT01102972 GlaxoSmithKline Clinical Study Register # 113734 ." ]

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

[ "Increased life expectancy has resulted in a greater provision of informal care within the community for patients with chronic physical health conditions .", "Informal carers are at greater risk of poor mental health , with one in three informal carers of stroke survivors experiencing depression .", "However , currently no psychological treatments tailored to the unique needs of depressed informal carers of stroke survivors exist .", "Furthermore , informal carers of stroke survivors experience a number of barriers to attending traditional face-to-face psychological services , such as lack of time and the demands of the caring role .", "The increased flexibility associated with supported cognitive behavioral therapy self-help ( CBTsh ) , such as the ability for support to be provided by telephone , email , or face-to-face , alongside shorter support sessions , may help overcome such barriers to access .", "CBTsh , tailored to depressed informal carers of stroke survivors may represent an effective and acceptable solution .", "This study is a Phase II ( feasibility ) randomized controlled trial ( RCT ) following guidance in the MRC Complex Interventions Research Methods Framework .", "We will randomize a sample of depressed informal carers of stroke survivors to receive CBT self-help supported by mental health paraprofessionals , or treatment-as-usual .", "Consistent with the objectives of assessing the feasibility of trial design and procedures for a potential larger scale trial we will measure the following outcomes : a ) feasibility of patient recruitment ( recruitment and refusal rates ) ; ( b ) feasibility and acceptability of data collection procedures ; ( c ) levels of attrition ; ( d ) likely intervention effect size ; ( e ) variability in number , length and frequency of support sessions estimated to bring about recovery ; and ( f ) acceptability of the intervention .", "Additionally , we will collect data on the diagnosis of depression , symptoms of depression and anxiety , functional impairment , carer burden , quality of life , and stroke survivor mobility skill , self-care and functional ability , measured at four and six months post-randomization .", "This study will provide important information for the feasibility and design of a Phase III ( effectiveness ) trial in the future .", "If the intervention is identified to be feasible , effective , and acceptable , a written CBTsh intervention for informal carers of stroke survivors , supported by mental health paraprofessionals , could represent a cost-effective model of care .", "Current Controlled Trials ISRCTN63590486 ." ]

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

[ "The purpose of this study was to investigate the effect of aerosolized fibrin sealant ( FS ) compared with that of polyvinyl acetal sponge packing on hemostasis and wound healing after functional endoscopic sinus surgery ( FESS ) .", "We conducted a prospective randomized controlled trial of the use of aerosolized FS in 41 consecutive patients who underwent bilateral FESS between February 2011 and March 2012 .", "The patients were randomized to receive FS applied via an aerosol spray in one nasal cavity and polyvinyl acetal sponge packing in the opposite cavity .", "The patients were followed up at 1 , 2 , 4 , 8 , and 12 weeks postoperatively .", "Crusting , adhesion , bleeding , granulation tissue formation , infection , and frontal sinus ostium stenosis after endoscopic surgery were assessed using a grading scale .", "Subjective symptoms related to nasal packing were evaluated using questionnaires quantified by visual analog scales .", "The degree of granulation and crusting was significantly reduced in the side treated with FS compared with the polyvinyl acetal sponge side , as were bleeding and pain during nasal packing removal ( p < 0.05 ) .", "In addition , general satisfaction and willingness to reuse the material were significantly higher for the FS-treated side than for the polyvinyl acetal sponge-packed side ( p < 0.001 ) .", "Compared with polyvinyl acetal sponge , aerosolized FS shows beneficial effects on hemostasis and wound healing after FESS .", "The application of FS resulted in a high degree of patient satisfaction without additional morbidity ." ]

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

[ "People infected with the human immunodeficiency virus are at an increased risk of developing ischemic heart disease ( IHD ) ; however , the effects of an education and home-based pedometer walking program on risk factors of IHD are not known .", "We conducted a 12-month randomized study of an education and home-based pedometer walking program in 84 human immunodeficiency virus-infected individuals with risk factors of IHD .", "Pedometer step count of the control and intervention groups improved significantly ( P = 0.03 for both groups ) at 6 months but was not significant at 12 months ( P = 0.33 and 0.21 , respectively ) .", "Significant between-group effects were observed in 6-minute walk test distance ( P = 0.01 ) , waist to hip ratio ( P = 0.00 ) , glucose ( P = 0.00 ) , and high-density lipoprotein ( P = 0.01 ) over the 12-month period .", "The program did not result in change in high-sensitivity C-reactive protein as it was associated with perceived stress ( r = 0.23 ; P = 0.03 ) , weight ( r = 0.28 ; P = 0.01 ) , body mass index ( r = 0.35 ; P < 0.00 ) , waist ( r = 0.28 ; P = 0.01 ) and hip circumference ( r = 0.28 ; P = 0.01 ) .", "Multivariate generalized estimation equation analysis demonstrated an inverse association between interaction and perceived stress ( logB = -0.01 ; 95 % confidence interval : -0.02 to -0.01 ; P < 0.00 ) and body mass index ( logB = -0.02 ; 95 % confidence interval : -0.03 to -0.002 ; P = 0.02 ) at group level .", "An education and home-based pedometer walking program improves physical activity levels , and beneficial changes in other IHD risk factors were noted ." ]

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

[ "At the time of the initial analysis of overall survival ( OS ) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer ( CONFIRM ) randomized , double-blind , phase III trial , approximately 50 % of patients had died .", "A final analysis of OS was subsequently planned for when 75 % of patients had died .", "Patients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0 , 14 , and 28 and every 28 ( 3 ) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections ( one fulvestrant and one placebo [ identical in appearance to study drug ] ) on days 0 , 14 ( two placebo injections only ) , and 28 and every 28 ( 3 ) days thereafter .", "OS was analyzed using an unadjusted log-rank test .", "No adjustments were made for multiplicity .", "Serious adverse events ( SAEs ) and best response to subsequent therapy were also reported .", "All statistical tests were two-sided .", "In total , 736 women ( median age = 61.0 years ) were randomly assigned to fulvestrant 500 mg ( n = 362 ) or 250 mg ( n = 374 ) .", "At the final survival analysis , 554 of 736 ( 75.3 % ) patients had died .", "Median OS was 26.4 months for fulvestrant 500 mg and 22.3 months for 250 mg ( hazard ratio = 0.81 ; 95 % confidence interval = 0.69-0 .96 ; nominal P = .02 ) .", "There were no clinically important differences in SAE profiles between the treatment groups ; no clustering of SAEs could be detected in either treatment group .", "Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups .", "In patients with locally advanced or metastatic estrogen receptor-positive breast cancer , fulvestrant 500 mg is associated with a 19 % reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250 mg .", "Fulvestrant 500 mg was well tolerated , and no new safety concerns were identified ." ]

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

[ "The purpose of this study was to compare the use of amoxicillin ( 1g ) vs amoxicillin and clavulanate ( 875/125mg ) after extraction of retained third molars for prevention of infectious complications .", "The study involved 546 patients attending for removal a retained third molar and divided in to two groups : Group 1 - amoxicillin and clavunate ( 875/125mg ) group ( n = 257 ) and Group 2 - amoxicillin ( 1g ) group ( n = 289 ) .", "All patients were recalled for investigating the possibility of infection , presence of diarrhea and further analgesic intake .", "From a total of 546 patients , the frequency of infection was 1.4 % , without no statistically differences between the two groups .", "Group 1 showed statistically higher presence of patients with gastrointestinal complications ( p > 0.05 ) .", "In 546 patients , 2.7 % of patients reported severe pain that would not relieve with medication .", "The results of our study show that the use of amoxicillin ( 1g ) and amoxicillin and clavunate ( 875/125mg ) is similar efficacious in preventing infection after retained third molar extraction but amoxicillin and clavunate ( 875/125mg ) produces more gastrointestinal discomfort ." ]

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

[ "The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers , allegedly due to high physical work demands of healthcare work .", "Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups , but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise .", "Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence .", "On the other hand , physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend .", "Thus , it seems relevant to compare the efficacy of workplace - versus home-based training on musculoskeletal pain .", "This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers .", "This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen , Denmark .", "Clusters are hospital departments and hospital units .", "Cluster randomization was chosen to increase adherence and avoid contamination between interventions .", "Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10weeks of 1 ) workplace based physical exercise performed during working hours ( using kettlebells , elastic bands and exercise balls ) for 510minutes per week and up to 5 group-based coaching sessions , or 2 ) home based physical exercise performed during leisure time ( using elastic bands and body weight exercises ) for 510minutes per week .", "Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. .", "Inclusion criteria are female healthcare workers working at a hospital .", "Average pain intensity ( VAS scale 0-10 ) of the back , neck and shoulder ( primary outcome ) and physical exertion during work , social capital and work ability ( secondary outcomes ) is assessed at baseline and 10-week follow-up .", "Further , postural balance and mechanical muscle function is assessed during clinical examination at baseline and follow-up .", "This cluster randomized trial will investigate the change in self-rated average pain intensity in the back , neck and shoulder after either 10 weeks of physical exercise at the workplace or at home .", "ClinicalTrials.gov ( NCT01921764 ) ." ]

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

[ "We compared the analgesic effects of caudal and ilioinguinal-iliohypogastric nerve block using bupivacaine-clonidine performed in children undergoing inguinal hernia repair .", "The ilioinguinal-iliohypogastric nerve block provides excellent pain relief for operations on the inguinal region , including emergency procedures ( e.g. strangulated inguinal hernia with intestinal obstruction ) .", "It should be preferred to caudal block for these procedures .", "After local ethics committee approval and written parental consent , 67 ASA class I - II patients aged between 2-7 years old scheduled for elective inguinal hernia repair were allocated randomly into two groups after general anesthesia with same drugs in both groups .", "Group C received caudal block with 1 ml/kg bupivacaine 0.25 % combined with 1 g/kg clonidine , and group I received ilioinguinal - iliohypogastric nerve block with 0.3 ml / kg bupivacaine 0.25 % combined with 1 g/kg clonidine .", "Blood pressure and heart rate were documented every 5 minutes .", "Post-operative analgesia , analgesic use and side-effects were assessed during first 24 hours .", "In group C , 7 / 34 and in group I , 12/33 patients required post-operative analgesia ( P = 0.174 ) .", "Five patients ( 15.5 % ) in group I and one patient ( 2.94 % ) in group C had severe pain after operation .", "Systolic and diastolic blood pressure decreased during operation , but the differences between two groups were not significant ( P = 0.176 , P = 0.111 ) .", "Heart rate changes between two groups were insignificant ( P = 0.182 ) .", "It seems that in children , caudal epidural block and ilioinguinal - iliohypogastric nerve block using bupivacaine-clonidine have comparable effects on analgesia , severity of pain and hemodynamic changes during and after surgery on inguinal region ." ]

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

[ "Work and being able to work are important prerequisites for health and well being .", "Health problems can have a negative influence on the ability to work and not being able to work can be detrimental for patients ' psychosocial well being .", "Although GPs are aware of this importance they do not always structurally pay attention to patients ' work during their daily practice .", "To investigate whether GPs can be trained to increase their awareness of work and improve their skills when dealing with work related problems we designed a cluster randomised controlled trial .", "The intervention in this trial is a tailored training based on the findings of qualitative research with focus groups of GPs .", "Gender aspects received specific attention in these focus groups .", "Primary outcome measures are self efficacy of patients concerning return to work , and GPs ' use of ICPC code Z05 ( work problems ) and registration of patients ' occupation .", "Secondary outcome measures are work awareness of GPs as perceived by patients , quality of life , health , use of care and illness related costs .", "A process evaluation will be part of our study .", "We investigate a training to increase work awareness among GPs , improve their skills in managing work related problems and structurally register work related data in the EMR .", "We think this study will make a contribution to better health care for workers by motivating GPs to appreciate their specific needs .", "It will also add to our knowledge of the complex relationship between gender , work and health ." ]

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

[ "Diabetes mellitus may be present in patients with cystic fibrosis starting in the second decade of life .", "The prevalence increases rapidly with increasing age .", "As life-expectancy increases in cystic fibrosis , cystic fibrosis related diabetes will be diagnosed more frequently in the future.Up to date , no data are available to answer the question if cystic fibrosis related diabetes should always initially be treated by insulin therapy .", "Missing data regarding oral antidiabetic treatment of newly diagnosed cystic fibrosis related diabetes are an important reason to recommend insulin treatment .", "Several centres report the successful management of cystic fibrosis related diabetes using oral anti-diabetic drugs at least for some years .", "Oral therapies would be less invasive for a patient group which is highly traumatized by a very demanding therapy .", "Based on an initiative of the German Mukoviszidosis-Foundation , the present study tries to answer the question , whether oral therapy with repaglinide is as effective as insulin therapy in cystic fibrosis patients with early diagnosed diabetes mellitus .", "In all cystic fibrosis patients with an age of 10 years or older , an oral glucose tolerance test is recommended .", "The result of this test is classified according to the WHO cut off values .", "It is required to have two diabetes positive oral glucose tolerance tests for the diagnosis of diabetes mellitus.This study is a multi-national , multicentre , open labelled , randomized and prospective controlled parallel group 's trial , with 24 months treatment.The primary objective of this trial is to compare the glycaemic control of oral therapy with Repaglinide with insulin injections in patients with cystic fibrosis related diabetes after 2 years of treatment.The trial should include 74 subjects showing cystic fibrosis related diabetes newly diagnosed by oral glucose tolerance test during annual screening for cystic fibrosis related diabetes.Patients are randomised by central fax randomisation.Primary endpoint is mean HbA1c after 24 months of treatment .", "Secondary endpoints are change in FEV1 % predicted and change in BMI-Z-score .", "There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia .", "The results regarding BMI after 6 months and 12 months showed an improvement for the insulin treated patients and were inconsistent for those treated with repaglinide .", "HbA1c and lung function ( FEV1 % pred ) were unchanged for either group .", "The authors compared the changes -12 months to baseline and baseline to +12 months separately for each group .", "Therefore a direct comparison of the effect of repaglinide versus insulin on BMI , HbA1c and FEV1 % pred was not presented .", "According to our protocol , we will directly compare treatment effects ( HbA1c , BMI , FEV1 % pred ) in between both groups .", "The actual Cochrane report regarding `` Insulin and oral agents for managing CFRD '' stated that further studies are needed to establish whether there is clear benefit for hypoglycemic agents .", "We expect that the results of our study will help to address this clinical need .", "ClinicalTrials.gov Identifier : NCT00662714 ." ]

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

[ "Calcium from different dairy sources might affect blood lipids and fecal fat excretion differently because of differences in the food matrix and nutritional composition .", "We investigated whether milk - and cheese-based diets with similar calcium contents affect a saturated fatty acid-induced increase in blood lipids differently .", "Fifteen healthy , young men participated in a randomized 3 2-wk crossover study in which the following 3 isocaloric diets that were similar in fat contents and compositions were compared : control diet [ nondairy diet ( ~ 500 mg Ca/d ) ] , milk diet [ semiskimmed milk-based diet ( 1700 mg Ca/d ) ] , and cheese diet [ semihard cow-cheese-based diet ( 1700 mg Ca/d ) ] .", "Blood was drawn before and after each period , and feces were collected for 5 d during each period .", "Saturated fatty acid-induced increases in total and low-density lipoprotein ( LDL ) cholesterol were lower with the milk diet ( mean SD : 0.57 0.13 and 0.53 0.11 mmol/L , respectively ) ( P < 0.01 ) and cheese diet ( 0.41 0.15 and 0.47 0.12 mmol/L , respectively ) ( P < 0.05 ) than with the control diet ( 0.89 0.12 and 0.84 0.11 mmol/L , respectively ) .", "Fecal fat excretion increased more with the consumption of both the milk ( 5.2 0.4 g/d ) and cheese ( 5.7 0.4 g/d ) diets than with the control diet ( 3.9 0.3 g/d ) ( P < 0.001 ) .", "Changes in blood pressure , high-density lipoprotein cholesterol , triglycerides , and lipid ratios did not differ .", "Compared with the control diet , milk - and cheese-based diets attenuated saturated fatty acid-induced increases in total and LDL cholesterol and resulted in increased fecal fat excretion ; however , effects of milk and cheese did not differ .", "Because the diets contained similar amounts of saturated fat , similar increases in total and LDL cholesterol could be expected ; however , both milk and cheese attenuated these responses , which seem to be explained by their calcium contents .", "This trial was registered at clinicaltrials.gov as NCT01317251 ." ]

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

[ "The aim of this study was to evaluate the effectiveness of middle turbinate radiofrequency ( RF ) turbinoplasty for the management of the polypoid middle turbinate compared to middle turbinate resection and middle turbinate medialization .", "The study was performed on 90 patients at a tertiary referral hospital with nasal polyposis resistant to maximal medical treatment .", "At the time of functional endoscopic sinus surgery ( FESS ) , patients were randomized into 3 groups with respect to the management of the middle turbinate : middle turbinate turbinoplasty by RF ; partial resection of the middle turbinate ; and medialization of the middle turbinate by scarification to the septum .", "We evaluated the patients ' symptoms according to the 22-item Sino-Nasal Outcome Test ( SNOT-22 ) preoperatively and 1 year after surgery .", "Additionally , polyp recurrence and complications were compared among the 3 groups .", "One year after surgery , there was no significant difference in SNOT-22 scores between the groups .", "However , the RF group had a significantly lower polyp recurrence rate when compared to other groups ( p < 0.05 ) .", "RF middle turbinate turbinoplasty could be considered an alternative to other common approaches , but it needs further long-term studies before widespread usage ." ]

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

[ "Addition of a MEK inhibitor to a BRAF inhibitor enhances tumour growth inhibition , delays acquired resistance , and abrogates paradoxical activation of the MAPK pathway in preclinical models of BRAF-mutated melanoma .", "We assessed the safety and efficacy of combined BRAF inhibition with vemurafenib and MEK inhibition with cobimetinib in patients with advanced BRAF-mutated melanoma .", "We undertook a phase 1b study in patients with advanced BRAF ( V600 ) - mutated melanoma .", "We included individuals who had either recently progressed on vemurafenib or never received a BRAF inhibitor .", "In the dose-escalation phase of our study , patients received vemurafenib 720 mg or 960 mg twice a day continuously and cobimetinib 60 mg , 80 mg , or 100 mg once a day for either 14 days on and 14 days off ( 14/14 ) , 21 days on and 7 days off ( 21/7 ) , or continuously ( 28/0 ) .", "The primary endpoint was safety of the drug combination and to identify dose-limiting toxic effects and the maximum tolerated dose .", "Efficacy was a key secondary endpoint .", "All patients treated with vemurafenib and cobimetinib were included in safety and efficacy analyses ( intention-to-treat ) .", "The study completed accrual and all analyses are final .", "This study is registered with ClinicalTrials.gov , number NCT01271803 .", "129 patients were treated at ten dosing regimens combining vemurafenib and cobimetinib : 66 had recently progressed on vemurafenib and 63 had never received a BRAF inhibitor .", "Dose-limiting toxic effects arose in four patients .", "One patient on a schedule of vemurafenib 960 mg twice a day and cobimetinib 80 mg once a day 14/14 had grade 3 fatigue for more than 7 days ; one patient on a schedule of vemurafenib 960 mg twice a day and cobimetinib 60 mg once a day 21/7 had a grade 3 prolongation of QTc ; and two patients on a schedule of vemurafenib 960 mg twice a day and cobimetinib 60 mg 28/0 had dose-limiting toxic effects-one developed grade 3 stomatitis and fatigue and one developed arthralgia and myalgia .", "The maximum tolerated dose was established as vemurafenib 960 mg twice a day in combination with cobimetinib 60 mg 21/7 .", "Across all dosing regimens , the most common adverse events were diarrhoea ( 83 patients , 64 % ) , non-acneiform rash ( 77 patients , 60 % ) , liver enzyme abnormalities ( 64 patients , 50 % ) , fatigue ( 62 patients , 48 % ) , nausea ( 58 patients , 45 % ) , and photosensitivity ( 52 patients , 40 % ) .", "Most adverse events were mild-to-moderate in severity .", "The most common grade 3 or 4 adverse events were cutaneous squamous-cell carcinoma ( 12 patients , 9 % ; all grade 3 ) , raised amounts of alkaline phosphatase ( 11 patients , 9 % ] ) , and anaemia ( nine patients , 7 % ) .", "Confirmed objective responses were recorded in ten ( 15 % ) of 66 patients who had recently progressed on vemurafenib , with a median progression-free survival of 28 months ( 95 % CI 26-34 ) .", "Confirmed objective responses were noted in 55 ( 87 % ) of 63 patients who had never received a BRAF inhibitor , including six ( 10 % ) who had a complete response ; median progression-free survival was 137 months ( 95 % CI 101-175 ) .", "The combination of vemurafenib and cobimetinib was safe and tolerable when administered at the respective maximum tolerated doses .", "The combination has promising antitumour activity and further clinical development is warranted in patients with advanced BRAF ( V600 ) - mutated melanoma , particularly in those who have never received a BRAF inhibitor ; confirmatory clinical testing is ongoing .", "F Hoffmann-La Roche/Genentech ." ]

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

[ "This study tested the hypothesis that early routine use of tranexamic acid ( TXA ) reduces mortality in a subset of the most critically injured trauma intensive care unit patients .", "Consecutive trauma patients ( n = 1,217 ) who required emergency surgery ( OR ) and/or transfusions from August 2009 to January 2013 were reviewed .", "At surgeon discretion , TXA was administered at a median of 97 minutes ( 1-g bolus then 1-g over 8 hours ) to 150 patients deemed high risk for hemorrhagic death .", "With the use of propensity scores based on age , sex , traumatic brain injury ( TBI ) , mechanism of injury , systolic blood pressure , transfusion requirements , and Injury Severity Score ( ISS ) , these patients were matched to 150 non-TXA patients .", "The study population was 43 years old , 86 % male , 54 % penetrating mechanism of injury , 25 % TBI , 28 ISS , with 22 % mortality .", "OR was required in 78 % at 86 minutes , transfusion was required in 97 % at 36 minutes , and 75 % received both .", "For TXA versus no TXA , more packed red blood cells and total fluid were required , and mortality was 27 % versus 17 % ( all p < 0.05 ) .", "The effects of TXA were similar in those with or without TBI , although ISS , fluid , and mortality were all higher in the TBI group .", "Mortality associated with TXA was influenced by the timing of administration ( p < 0.05 ) , but any benefit was eliminated in those who required more than 2,000-mL packed red blood cells , who presented with systolic blood pressure of less than 120 mm Hg or who required OR ( all p < 0.05 ) .", "For the highest injury acuity patients , TXA was associated with increased , rather than reduced , mortality , no matter what time it was administered .", "This lack of benefit can probably be attributed to the rapid availability of fluids and emergency OR at this trauma center .", "Prospective studies are needed to further identify conditions that may override the benefits from TXA .", "Therapeutic study , level IV ." ]

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

[ "This study aimed to examine the correlation of heart rate variability ( HRV ) and meridian electrical conductance among middle-aged women during an 8-week period of auricular acupressure ( AA ) treatment for weight reduction .", "Sixty ( 60 ) subjects were randomized either to a control group ( n = 30 ) or to a treatment group with AA ( n = 30 ) .", "Anthropometric parameters , HRV indices , and meridian levels were measured before treatment , at the 5th week , and 1 week after the 8-week treatment period .", "Although no significant changes were observed in body weight ( BW ) and body-mass index ( BMI ) from baseline to 1 week after AA treatment , a significant decrease in Waist Circumference ( WC ) was observed in the acupressure group .", "In contrast , the subjects ' BW , BMI , and WC were significantly increased from baseline to the 9th week in the control group .", "With adjustment for baseline low frequencies ( LF ) of HRV , the LF at the 5th and 9th weeks in the acupressure groups was generally lower than that in the control group , with a p-value = 0.027 using the mixed linear model .", "The meridian levels for Spleen , Bladder , and Gallbladder were significantly lower in the group subjected to acupressure than in the control group at the 5th week .", "The results of the present study indicate that AA tends to inactivate the sympathetic nervous activity demonstrated by both HRV and meridian electrical conductance changes .", "As a result , AA may modulate the autonomic nervous system to exert its physiological effect through the pathway of the meridian system ." ]

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

[ "The glycemic management of patients with type 2 diabetes mellitus ( T2DM ) and renal impairment is challenging , with few treatment options .", "We investigated the effect of saxagliptin in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus ( SAVOR ) - Thrombolysis in Myocardial Infarction ( TIMI ) 53 trial according to baseline renal function .", "Patients with T2DM at risk for cardiovascular events were stratified as having normal or mildly impaired renal function ( estimated glomerular filtration rate [ eGFR ] > 50 mL/min/1 .73 m ( 2 ) ; n = 13,916 ) , moderate renal impairment ( eGFR 30-50 mL/min/1 .73 m ( 2 ) ; n = 2,240 ) , or severe renal impairment ( eGFR < 30 mL/min/1 .73 m ( 2 ) ; n = 336 ) and randomized to receive saxagliptin or placebo .", "The primary end point was cardiovascular death , myocardial infarction , or ischemic stroke .", "After a median duration of 2 years , saxagliptin neither increased nor decreased the risk of the primary and secondary composite end points compared with placebo , irrespective of renal function ( all P for interactions 0.19 ) .", "Overall , the risk of hospitalization for heart failure among the three eGFR groups of patients was 2.2 % ( referent ) , 7.4 % ( adjusted hazard ratio [ HR ] 2.38 [ 95 % CI 1.95-2 .91 ] , P < 0.001 ) , and 13.0 % ( adjusted HR 4.59 [ 95 % CI 3.28-6 .28 ] , P < 0.001 ) , respectively .", "The relative risk of hospitalization for heart failure with saxagliptin was similar ( P for interaction = 0.43 ) in patients with eGFR > 50 mL/min/1 .73 m ( 2 ) ( HR 1.23 [ 95 % CI 0.99-1 .55 ] ) , eGFR 30-50 mL/min/1 .73 m ( 2 ) ( HR 1.46 [ 95 % CI 1.07-2 .00 ] ) , and in patients with eGFR < 30 ( HR 0.94 [ 95 % CI 0.52-1 .71 ] ) .", "Patients with renal impairment achieved reductions in microalbuminuria with saxagliptin ( P = 0.041 ) that were similar to those of the overall trial population .", "Saxagliptin did not affect the risk of ischemic cardiovascular events , increased the risk of heart failure hospitalization , and reduced progressive albuminuria , irrespective of baseline renal function ." ]

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

[ "High-dose statin loading is known to reduce periprocedural myocardial infarction and contrast-induced acute kidney injury in patients undergoing percutaneous coronary intervention .", "However , the clinical role of high-dose statin loading in patients with acute heart failure ( AHF ) remains unknown .", "In a prospective , single-center , randomized , controlled , open-label pilot study , patients hospitalized with AHF were randomly assigned to receive oral high-dose atorvastatin loading ( 80 mg for 3 days , followed by 10 mg/day until discharge ) or no statin therapy , on top of optimal HF treatment .", "The primary outcome measures were changes to the level of biomarkers related to inflammation and renal injury from admission to hospital day 4 .", "No significant changes in the levels of NT-proBNP ( -2,6274,956 vs. -2,9816,951 pg/ml , P = 0.845 ) , hsCRP ( -6.116.4 vs. -2.116.2 mg/L , P = 0.105 ) , cystatin C ( 0.0020.185 vs. 0.0090.216 mg/L , P = 0.904 ) , ACR ( -886.31,984.9 vs. -165.6825.2 mg/day , P = 0.124 ) were observed in either group .", "In-hospital mortality ( 4.3 % vs. 3.8 % , P > 0.999 ) and all-cause mortality at 90 days ( 4.3 % vs. 3.8 % , P > 0.999 ) were not significantly different between groups .", "This pilot study showed that oral high-dose atorvastatin loading may be used safely in patients with AHF , but is not effective in reducing the levels of circulating biomarkers related to inflammation and renal injury during hospitalization ." ]

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

[ "There is growing recognition of a syndrome of disturbed grief referred to as prolonged grief disorder ( PGD ) .", "PGD is mostly studied in adults , but clinically significant PGD symptoms have also been observed in children and adolescents .", "Yet , to date no effective treatment for childhood PGD exists .", "The aims of this study are : ( 1 ) to investigate the effectiveness of Grief-Help , a nine-session cognitive-behavioural treatment for childhood PGD , combined with five sessions of parental counselling , immediately after the treatment and at three , six and twelve months follow-up ; ( 2 ) to examine tentative mediators of the effects of Grief-Help , ( i.e. , maladaptive cognitions and behaviours and positive parenting ) , and ( 3 ) to determine whether demographic variables , child personality , as well as symptoms of PGD , anxiety , and depression in parents moderate the treatment effectiveness .", "We will conduct a Randomised Controlled Trial ( RCT ) in which 160 children and adolescents aged 8-18years are randomly allocated to cognitive behavioural Grief-Help or to a supportive counselling intervention ; both treatments are combined with five sessions of parental counselling .", "We will recruit participants from clinics for mental health in the Netherlands .", "The primary outcome measure will be the severity of Prolonged Grief Disorder symptoms according to the Inventory of Prolonged Grief for Children ( IPG-C ) .", "Secondary outcomes will include PTSD , depression and parent-rated internalizing and externalizing problems .", "Mediators like positive parenting and maladaptive cognitions and behaviours will be identified .", "We will also examine possible moderators including demographic variables ( e.g. time since loss , cause of death ) , psychopathology symptoms in parents ( PGD , anxiety and depression ) and child personality .", "Assessments will take place in both groups at baseline , after the treatment-phase and three , six and twelve months after the post-treatment assessment .", "We aim to contribute to the improvement of mental health care for children and adolescents suffering from loss .", "By comparing Grief-Help with supportive counselling , and by investigating mediators and moderators of its effectiveness we hope to provide new insights in the effects of interventions for bereaved children , and their mechanisms of change .", "Netherlands Trial Register NTR3854 ." ]

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