Lavender aromatherapy has improved sleep in a variety of clinical settings , but the effect has not been tested in the intermediate care unit .


To determine the effect of inhalation of 100 % lavender oil on patients ' vital signs and perceived quality of sleep in an intermediate care unit .


A randomized controlled pilot study was conducted in 50 patients .


Control patients received usual care .


The treatment group had 3 mL of 100 % pure lavender oil in a glass jar in place at the bedside from 10 pm until 6 am .


Vital signs were recorded at intervals throughout the night .


At 6 am all patients completed the Richard Campbell Sleep Questionnaire to assess quality of sleep .


Blood pressure was significantly lower between midnight and 4 am in the treatment group than in the control group ( P = .03 ) According to the overall mean change score in blood pressure between the baseline and 6 am measurements , the treatment group had a decrease in blood pressure and the control group had an increase ; however , the difference between the 2 groups was not significant ( P = .12 ) .


Mean overall sleep score was higher in the intervention group ( 48.25 ) than in the control group ( 40.10 ) , but the difference was not significant .


Lavender aromatherapy may be an effective way to improve sleep in an intermediate care unit .


Some observational studies have reported that transfusion of red-cell units that have been stored for more than 2 to 3 weeks is associated with serious , even fatal , adverse events .


Patients undergoing cardiac surgery may be especially vulnerable to the adverse effects of transfusion .


We conducted a randomized trial at multiple sites from 2010 to 2014 .


Participants 12 years of age or older who were undergoing complex cardiac surgery and were likely to undergo transfusion of red cells were randomly assigned to receive leukocyte-reduced red cells stored for 10 days or less ( shorter-term storage group ) or for 21 days or more ( longer-term storage group ) for all intraoperative and postoperative transfusions .


The primary outcome was the change in Multiple Organ Dysfunction Score ( MODS ; range , 0 to 24 , with higher scores indicating more severe organ dysfunction ) from the preoperative score to the highest composite score through day 7 or the time of death or discharge .


The median storage time of red-cell units provided to the 1098 participants who received red-cell transfusion was 7 days in the shorter-term storage group and 28 days in the longer-term storage group .


The mean change in MODS was an increase of 8.5 and 8.7 points , respectively ( 95 % confidence interval for the difference , -0.6 to 0.3 ; P = 0.44 ) .


The 7-day mortality was 2.8 % in the shorter-term storage group and 2.0 % in the longer-term storage group ( P = 0.43 ) ; 28-day mortality was 4.4 % and 5.3 % , respectively ( P = 0.57 ) .


Adverse events did not differ significantly between groups except that hyperbilirubinemia was more common in the longer-term storage group .


The duration of red-cell storage was not associated with significant differences in the change in MODS .


We did not find that the transfusion of red cells stored for 10 days or less was superior to the transfusion of red cells stored for 21 days or more among patients 12 years of age or older who were undergoing complex cardiac surgery .


( Funded by the National Heart , Lung , and Blood Institute ; RECESS ClinicalTrials.gov number , NCT00991341 . )


The two largest studies of mammalian target of rapamycin inhibitor treatment of autosomal dominant polycystic kidney disease ( ADPKD ) demonstrated no clear benefit on the primary endpoint of total kidney volume ( TKV ) or on eGFR .


The present study evaluated two levels of rapamycin on the 12-month change in ( 125 ) I-iothalamate GFR ( iGFR ) as the primary endpoint and TKV secondarily .


In a 12-month open-label pilot study , 30 adult patients with ADPKD were randomly assigned to low-dose ( LD ) rapamycin ( rapamycin trough blood level , 2-5 ng/ml ) ( LD group , n = 10 ) , standard-dose ( STD ) rapamycin trough level ( > 5-8 ng/ml ) ( STD group , n = 10 ) , or standard care ( SC group , n = 10 ) .


They were evaluated with iGFR and noncontrast computed tomography .


Change in iGFR at 12 months was significantly higher in the LD group ( 7.712.5 ml/min per 1.73 m ( 2 ) ; n = 9 ) than in the SC group ( -11.2 9.1 ml/min per 1.73 m ( 2 ) ; n = 9 ) ( LD versus SC : P < 0.01 ) .


Change in iGFR at 12 months in the STD group ( 1.6 12.1 ml/min per 1.73 m ( 2 ) ; n = 8 ) was not significantly greater than that in the SC group ( P = 0.07 ) , but it was in the combined treatment groups ( LD+STD versus SC : P < 0.01 ) .


Neither eGFR calculated by the CKD-Epidemiology Collaboration equation nor TKV ( secondary endpoint ) changed significantly from baseline to 12 months in any of the groups .


On the basis of results of the mixed model , during the study , patients in the LD group had significantly lower trough blood levels of rapamycin ( mean range SD , 2.40 0.64 to 2.90 1.20 ng/ml ) compared with those in the STD group ( 3.93 2.27 to 5.77 1.06 ng/ml ) ( P < 0.01 ) .


Patients with ADPKD receiving LD rapamycin demonstrated a significant increase in iGFR compared with those receiving standard care , without a significant effect on TKV after 12 months .


Conclusive evidence indicating an effective treatment for carpal tunnel syndrome ( CTS ) , a common entrapment neuropathy , is lacking .


Ultrasound therapy ( US therapy ) has long been used as one of the combination treatments for CTS .


In addition , paraffin bath therapy has been applied widely as a physical modality in treating patients with hand conditions .


The purpose of this randomized trial was to compare the efficacy of combining a wrist orthosis with either US therapy or paraffin bath therapy in treating CTS patients .


Patients with CTS were randomized into two groups .


All patients received a wrist orthosis .


Twice per week , one group underwent paraffin therapy , and the other group underwent ultrasound therapy .


Each patient received a questionnaire , physical examination and nerve conduction study of the upper extremities before and after treatment for eight weeks .


Sixty patients were recruited , and 47 completed the study .


Statistical analysis revealed significant improvements in symptom severity scores in both groups .


After adjusting for age , gender and baseline data , the analysis of covariance revealed a significant difference in the functional status score between two groups .


The combination of ultrasound therapy with a wrist orthosis may be more effective than paraffin therapy with a wrist orthosis .


Clinicaltrial.gov : NCT02278289 Oct 28 , 2014 .


To study the role of exercise in asthma management in children and formulate exercise prescriptions for asthmatic children .


A total of 112 asthmatic children aged 7-14 years were randomized into control group ( n = 56 , with medications only ) and exercise group ( n = 56 , with medications and exercise prescription ) for a trial lasting for 4 months .


An asthma diary was used for all children to record the morning and evening peak expiratory flow ( PEF ) , daytime and nighttime asthma symptom score , use of short-acting beta agonists , participation in physical activity , and exercise-induced asthma symptoms .


Of the 112 children , 5 dropped out before the trial completion .


From the 13th week , PEF variation in exercise group was significantly lowered compared to that in the control group ( P < 0.05 ) .


Upon the completion of the trial , the daytime and nighttime symptoms score and emergency medication score were all significantly lower in the exercise group than in the control group ( P < 0.05 ) .


No severe adverse events occurred in the children during the trial .


Exercise for no less than 20 min , 3 days a week for 4 months is safe and beneficial for asthma control in children .


Karydakis flap ( K-flap ) and excision with healing by secondary intention ( EHSI ) are currently accepted methods for surgical management of sacrococcygeal pilonidal disease .


This clinical trial study aimed to compare early and late outcomes of these two surgical techniques .


In this controlled , prospective , randomized clinical trial , patients diagnosed with sacrococcygeal pilonidal disease were randomly allocated to two groups .


Patients in the first group underwent Karydakis procedure , whereas EHSI was the surgical management in the second group .


The two techniques were compared based on their overall time of wound healing , return to work , rate of complications , and recurrence .


A total of 321 patients including 161 in the K-flap group and 160 in the EHSI group were included in the study .


The median follow-up duration was 49 mo. .


The mean time of wound healing ( 16.44 versus 80.01 d , P < 0.001 ) , return to work ( 14.44 versus 24.19 , P < 0.001 ) , rate of wound complications ( 18.7 % versus 31.2 % , P = 0.006 ) , and recurrence ( 1.2 % versus 7.5 % , P = 0.005 ) were all significantly lower in the K-flap group .


The mean operation time was significantly shorter in the EHSI group ( 15.87 versus 55.17 min , P < 0.001 ) .


The K-flap group showed significantly higher pain on their first postoperative day and significantly less pain after 1 wk ( P < 0.001 ) .


Although both techniques are safe , the K-flap is associated with significantly lower rates of complications and recurrence and significantly shorter time of wound healing and return to work .


The adverse prognostic impact of metabolic syndrome ( METS ) in unselected populations and in patients with coronary heart disease has been previously shown .


The aim of the current analysis was to evaluate the impact of METS on prognosis in chronic heart failure ( HF ) .


International Diabetes Federation criteria were used for the diagnosis of METS .


Adjusted Cox regression models with all-cause and HF death as outcomes were fitted in 6648 patients enrolled in GISSI-HF trial with no missing values for the variables of interest .


Risk of all-cause and HF death was significantly reduced in patients with METS compared to patients without METS ( HR : 0.83 , 95 % CI : 0.72 to 0.95 , p = 0.005 ; HR : 0.76 , 95 % CI : 0.59 to 0.98 , p = 0.031 ; respectively ) .


As compared with patients with no METS and no type 2 diabetes mellitus ( DM ) , the risk of all-cause and HF death was significantly lower in patients with METS and no DM ( HR : 0.76 , 95 % CI : 0.62 to 0.95 , p = 0.015 ; HR : 0.65 , 95 % CI : 0.42 to 0.99 , p = 0.046 ; respectively ) , whereas it was significantly increased in patients with DM and no METS ( HR : 1.34 , 95 % CI : 1.21 to 1.48 , p < 0.001 ; HR : 1.44 , 95 % CI : 1.21 to 1.72 , p < 0.001 ; respectively ) .


Patients with METS and DM showed no difference for risk of total and HF death compared with patients with no METS and no DM ( HR : 1.03 , 95 % CI : 0.87 to 1.21 , p = 0.762 ; HR : 0.99 ; 95 % CI : 0.73 to 1.35 ; p = 0.963 ; respectively ) .


METS is associated with reduced all-cause and HF mortality in patients with HF .


HF patients with DM without METS are at the highest risk of mortality , whereas METS attenuates mortality risk in HF patients with DM .


The aim of this randomized , crossover study was to determine if transoral fundoplication ( TF ) could further improve clinical outcomes in partial responders to high-dose ( HD ) proton-pump inhibitor ( PPI ) therapy and to evaluate durability of TF .


In seven United States centers , patients with hiatal hernia 2 cm and abnormal esophageal acid exposure ( EAE ) were randomized to TF ( n = 40 ) or HD PPIs ( n = 23 ) group .


At 6-month follow-up , PPI patients underwent crossover .


We assessed clinical outcomes 6-month post TF in crossover patients ( COP ) , as compared to 6-month of HD PPI therapy , and 12-month outcomes in patients initially randomized to TF .


The primary outcome was symptom control evaluated by Reflux Disease Questionnaire and Reflux Symptom Index .


Secondary outcomes included healing of esophagitis , normalization of EAE and PPI use after TF .


We analyzed 21 COP and 39 TF patients .


McNemar 's test or Fisher exact test was used to compare proportions .


Of 63 randomized patients , 3 were lost to follow-up , leaving 39 TF and 21 COP for analyses .


In the COP , TF further improved control of regurgitation and of atypical symptoms achieved after six months of HD PPIs .


Of 20 patients with GERD symptoms after six months of high-dose PPI therapy , 65 % ( 13/20 ) reported global elimination of troublesome regurgitation and atypical symptoms post TF off PPIs ; 67 % ( 6/9 ) reported no troublesome regurgitation .


Esophagitis further healed in 75 % ( 6/8 ) of patients .


Seventy-one percent of COP patients were off PPIs six months following TF .


Normalization of EAE decreased from 52 % after HD PPIs ( on PPIs ) to 33 % after TF ( off PPIs ) , p = 0.388 .


In the original TF group , 12-month post TF , 77 % of patients achieved complete symptom control , 82 % ceased PPI therapy , 100 % healed esophagitis and 45 % normalized EAE .


The results of this study indicate that in patients with incomplete symptom control on high-dose PPI therapy TF may provide further elimination of symptoms and esophagitis healing .


In the original TF group , the clinical outcomes of TF remained stable between 6 - and 12-month follow-up .


Sepsis bundles can decrease mortality in patients with severe sepsis or septic shock .


However , current methods of measuring pressure , such as central venous pressure , are inadequate .


This study investigated the effect of improved sepsis bundles informed by pulse-indicated continuous cardiac output .


We compared the outcome of treatment with sepsis bundles informed by either conventional pressure measurements or pulse-indicated continuous cardiac output .


Patients in 2 groups received fluid resuscitation , standard antibiotics , and oxygen therapy .


A total of 105 patients with septic shock were randomly divided into 2 groups : the conventional sepsis bundle group ( n = 52 ) or the improved sepsis bundle group ( ISBG , n = 53 ) .


The ISBG significantly reduced the mean Acute Physiology and Chronic Health Evaluation II and Sepsis-related Organ Failure Assessment scores .


Significantly fewer ISBG-treated patients received vasoactive drugs compared to conventional sepsis bundle group-treated patients .


In addition , patients in the ISBG exhibited a significantly increased arterial blood lactate clearance rate and required less total fluid resuscitation and a shorter duration of mechanical ventilation and stay in the intensive care unit .


Pulse-indicated continuous cardiac output-directed sepsis bundles can reduce the severity of septic shock , provide more accurate fluid resuscitation , and reduce the duration of mechanical ventilation and stay in the intensive care unit .


Pain is a common distressing adverse effect in the early postoperative period following caesarean section .


The aim of this study was to investigate the effect on postoperative pain , analgesic requirement and haemodynamic profile of placing a suprafacial bupivacaine-soaked absorbable gelatin sponge in the caesarean section wound .


A total of 164 healthy patients scheduled to undergo general anaesthesia for elective caesarean section were randomised to a study group ( n = 81 ) or a control group ( n = 83 ) .


In the study group , a bupivacaine-soaked absorbable gelatin sponge was placed subcutaneously in the caesarean section wound .


Intramuscular diclofenac 75 mg was given to all patients at 8-h intervals during the first 24h .


Postoperatively , visual analogue scale pain scores , requirement for pethidine and diclofenac and changes in blood pressure and heart rate were compared between groups .


Pain scores were lower in the study group compared to the control group at all assessments ( P < 0.001 ) .


During the first eight hours after surgery , fewer patients in the study group required rescue pethidine compared with the control group ( 4 vs. 33 , P < 0.001 ) .


In the study group , total opioid and diclofenac consumption was lower ( P < 0.001 ) , and blood pressure and heart rate were lower ( P < 0.001 ) compared to the control group .


Suprafascial wound placement of a bupivacaine-soaked absorbable gelatin sponge improved postoperative analgesia and decreased opioid consumption following caesarean section .


Transfusion of erythrocytes stored for prolonged periods is associated with increased mortality .


Erythrocytes undergo hemolysis during storage and after transfusion .


Plasma hemoglobin scavenges endogenous nitric oxide leading to systemic and pulmonary vasoconstriction .


We hypothesized that transfusion of autologous blood stored for 40 days would increase the pulmonary artery pressure in volunteers with endothelial dysfunction ( impaired endothelial production of nitric oxide ) .


We also tested whether breathing nitric oxide before and during transfusion could prevent the increase of pulmonary artery pressure .


Fourteen obese adults with endothelial dysfunction were enrolled in a randomized crossover study of transfusing autologous , leukoreduced blood stored for either 3 or 40 days .


Volunteers were transfused with 3-day blood , 40-day blood , and 40-day blood while breathing 80 ppm nitric oxide .


The age of volunteers was 41 4 years ( mean SEM ) , and their body mass index was 33.4 1.3 kg/m ( 2 ) .


Plasma hemoglobin concentrations increased after transfusion with 40-day and 40-day plus nitric oxide blood but not after transfusing 3-day blood .


Mean pulmonary artery pressure , estimated by transthoracic echocardiography , increased after transfusing 40-day blood ( 18 2 to 23 2 mm Hg ; P < 0.05 ) but did not change after transfusing 3-day blood ( 17 2 to 18 2 mm Hg ; P = 0.5 ) .


Breathing nitric oxide decreased pulmonary artery pressure in volunteers transfused with 40-day blood ( 17 2 to 12 1 mm Hg ; P < 0.05 ) .


Transfusion of autologous leukoreduced blood stored for 40 days was associated with increased plasma hemoglobin levels and increased pulmonary artery pressure .


Breathing nitric oxide prevents the increase of pulmonary artery pressure produced by transfusing stored blood .


Clinical trial registered with www.clinicaltrials.gov ( NCT 01529502 ) .


To explore perceptions of spinal manipulative therapy and exercise among adults aged 65 years and older with chronic neck pain .


Mixed methods study embedded within a randomized clinical trial .


Interviews were conducted with 222 of 241 randomized clinical trial participants .


They had a mean age of 72.2 years and they had neck pain of moderate severity and of 6 years mean duration .


Semi-structured interviews were conducted at the completion of the 12 week intervention phase , during which participants received spinal manipulative therapy and exercise interventions .


Interviews explored determinants of satisfaction with care , whether or not therapy was worthwhile , and what was liked and disliked about treatment .


Interviews were recorded and transcribed ; content analysis was used to identify themes within responses .


Participants placed high value on their relationships with health care team members , supervision , individualized care , and the exercises and information provided as treatment .


Change in symptoms did not figure as prominently as social and process-related themes .


Percpetions of age , activities , and co-morbities influenced some seniors ' expectations of treatment results , and comorbidities impacted perceptions of their ability to participate in active care .


Relationship dynamics should be leveraged in clinical encounters to enhance patient satisfaction and perceived value of care .


Salivary gland tumors are mostly benign tumors .


Whether a more conservative surgical approach at greater risk of recurrence , or a more radical intervention with an increased risk of facial paralysis is warranted is still under discussion .


Our study addresses the opportunity for improving surgical outcome by employing platelet-rich plasma ( PRP ) gel at the surgical site .


Twenty consecutive patients undergoing superficial parotidectomy were randomized and assigned to two groups , one with and one without PRP gel .


Many parameters were evaluated after surgery and during follow-up , such as the duration of hospitalization , facial nerve deficit , onset of Frey 's syndrome , relapse , cosmetic results , presence of keloid or scar depressions , behavior of several facial muscles .


Our explorative analysis suggests a positive effect of PRP on surgical outcome in patients undergoing parotidectomy , whereas no negative effects were detected .


This work suggests that administration of PRP in patients undergoing parotidectomy is beneficial .


There is a growing recognition that cancer not only affects the lives of the patients , but also the lives of their partners .


Partners of cancer patients are highly involved in the illness trajectory by providing informal care and they often experience distress .


However , supporting interventions for this group are scarce and existing interventions bear several limitations .


On the basis of the need for theory - and evidence-based supportive interventions for partners of cancer patients , the web-based self-help intervention Hold on , for each other has been developed .


This intervention is based on Acceptance and Commitment Therapy .


The primary objective of the RCT is to investigate the ( cost - ) effectiveness of the intervention .


Additional goals are ( 1 ) to examine if psychological flexibility , self-compassion , mastery , supportive behavior , posttraumatic growth and resilience are mediators of the intervention 's effects on the partners ' mental health ; ( 2 ) to examine the moderating effects of the socio demographics ( age , gender , education , working situation , family situation ) and disease-related characteristics of the patients ( sort of cancer , stage of disease , duration and treatment of cancer ) ; and ( 3 ) to investigate to what extend participants are satisfied with the intervention , which parts of the intervention are mostly used , and how adherent the users are .


A three-armed randomized controlled trial ( RCT ) will be conducted to compare two versions of the intervention Hold on , for each other with a waiting list control condition .


Both intervention conditions contain the same content and differ only with regard to the form of professional support ( personal support versus automatic support ) .


Adult partners of cancer patients with mild to moderate depressive and anxiety symptoms , will be recruited through a multi-component strategy .


Online measurements by self-assessment will be made on four measurement points ( prior to randomization ( baseline-measurement ) and 3 , 6 and 12 months after baseline ) .


When proven effective , Hold on , for each other can be an invaluable contribution to the healthcare system and it could be offered to all partners of cancer patients who are in need for additional support .


Dutch Trial Register , trial registration number NTR4035 , date of registration : 17 March 2013 .


Ensuring an open airway during cardiopulmonary resuscitation is fundamental .


The aim of this study was to determine the success rate of blind intubation during simulated cardiopulmonary resuscitation by untrained personnel .


Four devices were compared in a simulated resuscitation scenario : ILMA ( Intavent Direct Ltd , Buckinghamshire , United Kingdom ) , Cobra PLA ( Engineered Medical Systems Inc , Indianapolis , IN ) , Supraglottic Airway Laryngopharyngeal Tube ( SALT ) ( ECOLAB , St. Paul , MN ) , and Air-Q ( Mercury Medical , Clearwater , FL ) .


A group of 210 paramedics intubated a manikin with continuous chest compressions .


The mean times to intubation were 40.46 4.64 , 33.96 6.23 , 17.2 4.63 , and 49.23 13.19 seconds ( SALT vs ILMA , Cobra PLA , and Air-Q ; P < .05 ) .


The success ratios of blind intubation for the devices were 86.7 % , 85.7 % , 100 % , and 71.4 % ( SALT vs ILMA , Cobra PLA , and Air-Q ; P < .05 ) .


The study showed that the most efficient device with the shortest blind intubation time was the SALT device .


Few scientific studies have examined movement-based embodied contemplative practices such as yoga and their effects on cognition .


The purpose of this randomized controlled trial was to examine the effects of an 8-week Hatha yoga intervention on executive function measures of task switching and working memory capacity .


Community-dwelling older adults ( N = 118 ; mean age = 62.0 ) were randomized to one of two groups : a Hatha yoga intervention or a stretching-strengthening control .


Both groups participated in hour-long exercise classes 3/week over the 8-week study period .


All participants completed established tests of executive function including the task switching paradigm , n-back and running memory span at baseline and follow-up .


Analysis of covariances showed significantly shorter reaction times on the mixed and repeat task switching trials ( partial ( 2 ) = .04 , p < .05 ) for the Hatha yoga group .


Higher accuracy was recorded on the single trials ( partial ( 2 ) = .05 , p < .05 ) , the 2-back condition of the n-back ( partial ( 2 ) = .08 , p < .001 ) , and partial recall scores ( partial ( 2 ) = .06 , p < .01 ) of running span task .


Following 8 weeks of yoga practice , participants in the yoga intervention group showed significantly improved performance on the executive function measures of working memory capacity and efficiency of mental set shifting and flexibility compared with their stretching-strengthening counterparts .


Although the underlying mechanisms need to be investigated , these results demand larger systematic trials to thoroughly examine effects of yoga on executive function as well as across other domains of cognition , and its potential to maintain or improve cognitive functioning in the aging process .


Soluble ST2 ( sST2 ) , a biomarker related to inflammation , is associated with outcomes of patients with heart failure .


In-depth analyses of the relationship among sST2 , changes in sST2 , and patient outcomes are reported .


sST2 was measured at baseline ( n = 1650 ) , 4 months ( n = 1345 ) , and 12 months ( n = 1094 ) in Valsartan Heart Failure Trial .


Baseline sST2 averaged 28.716.2 ng/mL , significantly ( P < 0.001 ) higher in men than women but supranormal in only 9 % and 15 % , respectively .


A continuous relationship between sST2 and the log hazard ratio for outcomes was modeled as 2 linear segments with a significant decrease in the rate of increase in hazard ratios > 33.2 ng/mL .


Each segment of the sST2 distribution was significantly ( P < 0.0001 ) associated with the risks of morbid event , mortality , and hospitalization for heart failure .


Only sST2 values < 33.2 ng/mL were significantly related to the outcomes when 23 readily available clinical variables including N-terminal probrain natriuretic peptide were included in the Cox regression model .


sST2 did not improve discrimination of patient outcomes .


Compared with placebo , valsartan significantly ( P < 0.001 ) reduced the rate of increase in sST2 .


Increases in sST2 for 12 months , but not decreases , were significantly associated with subsequent outcomes , independent of clinical variables , sST2 , and valsartan treatment .


In this study , baseline sST2 was nonlinearly associated with patient outcomes but did not provide substantial prognostic information when added to a clinical prediction model that included N-terminal probrain natriuretic peptide .


An increase but not decrease in sST2 was independently associated with outcomes .


Additional research is needed to determine whether monitoring ST2 levels can improve patient outcomes .


The aim of the present study was to compare the effects of preemptive intravenous tenoxicam and methylprednisolone administrations on extraction of impacted third molars .


This was a placebo-controlled , randomized , double-blind , clinical trial .


A total of 60 adult patients ages 18-40 years with the complaints of impacted third molar teeth were included in the study .


The postoperative swelling ratios ( p < 0.05 ) and pain scores ( p < 0.05 ) were significantly better in both study groups than in the control group and there was no statistically significant difference between methylprednisolone and tenoxicam groups with regards to the edema and pain relief .


Preoperative administration of 80 mg methylprednisolone achieves better control of trismus than tenoxicam without any significant differences in edema and pain control in impacted third molar teeth extraction .


GLP-1 receptor agonists may provide an alternative to prandial insulin for advancing basal insulin therapy .


Harmony 6 was a randomized , open-label , active-controlled trial testing once-weekly albiglutide vs. thrice-daily prandial insulin lispro as an add-on to titrated once-daily insulin glargine .


Patients taking basal insulin ( with or without oral agents ) with HbA1c 7-10 .5 % ( 53-91 mmol/mol ) entered a glargine standardization period , followed by randomization to albiglutide , 30 mg weekly ( n = 282 ) , subsequently uptitrated to 50 mg , if necessary , or thrice-daily prandial lispro ( n = 281 ) while continuing metformin and/or pioglitazone .


Glargine was titrated to fasting plasma glucose of < 5.6 mmol/L , and lispro was adjusted based on glucose monitoring .


The primary end point was the difference in the HbA1c change from baseline at week 26 .


At week 26 , HbA1c decreased from baseline by -0.82 SE 0.06 % ( 9.0 mmol/mol ) with albiglutide and -0.66 0.06 % ( 7.2 mmol/mol ) with lispro ; treatment difference , -0.16 % ( 95 % CI -0.32 to 0.00 ; 1.8 mmol/mol ; P < 0.0001 ) , meeting the noninferiority end point ( margin , 0.4 % ) .


Weight decreased with albiglutide but increased with lispro ( -0.73 0.19 kg vs. +0.81 0.19 kg ) .


The mean glargine dose increased from 47 to 53 IU ( albiglutide ) and from 44 to 51 IU ( lispro ) .


Adverse events for albiglutide versus lispro included severe hypoglycemia ( 0 vs. 2 events ) , documented symptomatic hypoglycemia ( 15.8 % vs. 29.9 % ) , nausea ( 11.2 % vs. 1.4 % ) , vomiting ( 6.7 % vs. 1.4 % ) , and injection site reactions ( 9.5 % vs. 5.3 % ) .


Weekly albiglutide is a simpler therapeutic option than thrice-daily lispro for advancing basal insulin glargine therapy , resulting in comparable HbA1c reduction with weight loss and lower hypoglycemia risk .


To present the long-term results of a prostate cancer ( PC ) screening trial conducted in a Mediterranean setting .


A total of 4276 men aged 45-70 years were randomized to screening arm ( PSA test performed ) and control arm ( no tests ) .


Transrectal ultrasonography-guided sextant prostate biopsy was conducted when PSA > or = 3ngml ( -1 ) .


Date and cause of death were retrieved from death certificates .


PC incidence , and disease-specific and overall mortality curves were plotted and comparison between arms was made .


Analysis of causes of death was also performed .


Median age at randomization was 57.0 years .


Median follow-up time was 15.2 years .


A total of 241 men were diagnosed with PC , 161 ( 6.7 % ) in the screening arm and 80 ( 4.3 % ) in the control arm ( P < 0.01 ) .


Eventually , 554 men ( 13 % ) died .


No difference in all-cause mortality was found between arms ( P = 0.34 ) .


Only 10 men ( 10/4276 , 0.23 % ) died from PC , no differences between arms ( P = 0.67 ) .


Overall , the main causes of death were malignancy ( 54.2 % ) , cardiovascular ( 17.9 % ) and respiratory ( 9.2 % ) diseases .


Main cancer causes of death were lung and bronchus cancer ( 37.2 % ) , colorectum ( 15.0 % ) and stomach ( 9.0 % ) cancer .


PC only accounted for 3.0 % of all malignant causes of death ( ranked 10th ) .


Our study failed to demonstrate benefits of PC screening in terms of all-cause and PC-specific mortality after a median follow-up of 15 years .


The limited sample size and the low long-term PC mortality observed in our setting were probably the most important factors to explain these results .


The pathogenesis of perihematoma edema in intracerebral hemorrhage ( ICH ) is unknown but has been hypothesized to be ischemic .


In the ICH Acutely Decreasing Arterial Pressure Trial ( ICH ADAPT ) , perihematoma cerebral blood flow ( CBF ) was reduced but was unaffected by blood pressure ( BP ) reduction .


Using ICH ADAPT data , we tested the hypotheses that edema growth is associated with reduced CBF and lower systolic BP .


Noncontrast computed tomographic scans in patients with ICH were obtained at baseline , 2 hours , and 24 hours after randomization to target systolic BPs of < 150 or < 180 mm Hg .


Computed tomography perfusion imaging was performed at 2 hours , and mean relative CBF was calculated in visibly edematous perihematoma tissue .


Edema volumes were measured using a Hounsfield unit threshold of 5 to 23 at each time-point .


Patients were randomized at a median ( interquartile range ) of 7.4 ( 12.8 ) hours after onset .


Treatment groups ( n = 34 , < 150 and n = 33 , < 180 target ) were balanced with respect to baseline systolic BP and acute ICH volume .


Relative edema growth at 24 hours in the < 150 group ( 0.110.19 ) was similar to that in the < 180 group ( 0.090.16 mL ; P = 0.727 ) .


Absolute CBF was lower in the edematous region ( 35.6713.1 mL/100 g per minute ) when compared with that in the contralateral tissue ( 43.711.7 mL/100 g per minute ; P < 0.0001 ) .


Linear regression indicated that neither systolic BP change ( = -0.022 ; 95 % confidence interval , -0.002 to 0.001 ) nor perihematoma relative CBF ( = -0.144 ; 95 % confidence interval , -0.647 to 0.167 ) predicted edema growth .


Lower perihematoma CBF and BP treatment do not exacerbate edema growth .


These data do not support a cytotoxic edema pathogenesis .


http://www.clinicaltrials.gov .


Unique identifier : NCT00963976 .


Despite their wide use , whether antiarrhythmic drugs improve survival after out-of-hospital cardiac arrest ( OHCA ) is not known .


The ROC-ALPS is evaluating the effectiveness of these drugs for OHCA due to shock-refractory ventricular fibrillation or pulseless ventricular tachycardia ( VF/VT ) .


ALPS will randomize 3,000 adults across North America with nontraumatic OHCA , persistent or recurring VF/VT after 1 shock , and established vascular access to receive up to 450 mg amiodarone , 180 mg lidocaine , or placebo in the field using a double-blind protocol , along with standard resuscitation measures .


The designated target population is all eligible randomized recipients of any dose of ALPS drug whose initial OHCA rhythm was VF/VT .


A safety analysis includes all randomized patients regardless of their eligibility , initial arrhythmia , or actual receipt of ALPS drug .


The primary outcome of ALPS is survival to hospital discharge ; a secondary outcome is functional survival at discharge assessed as a modified Rankin Scale score 3 .


The principal aim of ALPS is to determine if survival is improved by amiodarone compared with placebo ; secondary aim is to determine if survival is improved by lidocaine vs placebo and/or by amiodarone vs lidocaine .


Prioritizing comparisons in this manner acknowledges where differences in outcome are most expected based on existing knowledge .


Each aim also represents a clinically relevant comparison between treatments that is worth investigating .


Results from ALPS will provide important information about the choice and value of antiarrhythmic therapies for VF/VT arrest with direct implications for resuscitation guidelines and clinical practice .


Renal dysfunction is associated with a variety of cardiac alterations including left ventricular ( LV ) hypertrophy , LV dilation , and reduction in systolic and diastolic function .


It is common and associated with an increased mortality risk in heart failure ( HF ) patients .


This study was designed to evaluate whether severe diastolic dysfunction contribute to the increased mortality risk observed in HF patients with renal dysfunction .


Using Cox Proportional Hazard Models on data ( N = 669 ) from the EchoCardiography and Heart Outcome Study ( ECHOS ) study we evaluated whether estimated glomerular filtration rate ( eGFR ) was associated with mortality risk before and after adjustment for severe diastolic dysfunction .


Severe diastolic dysfunction was defined by a restrictive left ventricular filling pattern ( RF ) ( = deceleration time < 140 ms ) by Doppler echocardiography .


Median eGFR was 58 ml/min/1 .73 m , left ventricular ejection fraction was 33 % and RF was observed in 48 % .


During the 7 year follow up period 432 patients died .


Multivariable adjusted eGFR was associated with similar mortality risk before ( Hazard Ratio ( HR ) ( eGFR 10 ml increase ) : 0.94 ( 95 % CI : 0.89-0 .99 , P = 0.024 ) and after ( HR ( eGFR 10 ml increase ) : 0.93 ( 0.89-0 .99 ) , P = 0.012 ) adjustment for RF ( HR : 1.57 ( 1.28-1 .93 ) , P < 0.001 ) .


In patients admitted with HF RF does not contribute to the increased mortality risk observed in patients with a decreased eGFR .


Factors other than severe diastolic dysfunction may explain the association between renal function and mortality risk in HF patients .


We investigated phenotypic and genotypic resistance after 2 years of first-line therapy with two HIV treatment regimens in the absence of virological monitoring .


NORA [ Nevirapine OR Abacavir study , a sub-study of the Development of AntiRetroviral Therapy in Africa ( DART ) trial ] randomized 600 symptomatic HIV-infected Ugandan adults ( CD4 cell count < 200 cells/mm ( 3 ) ) to receive zidovudine/lamivudine plus abacavir ( cABC arm ) or nevirapine ( cNVP arm ) .


All virological tests were performed retrospectively , including resistance tests on week 96 plasma samples with HIV RNA levels 1000 copies/mL .


Phenotypic resistance was expressed as fold-change in IC ( 50 ) ( FC ) relative to wild-type virus .


HIV-1 RNA viral load 1000 copies/mL at week 96 was seen in 58/204 ( 28.4 % ) cABC participants and 21/159 ( 13.2 % ) cNVP participants .


Resistance results were available in 35 cABC and 17 cNVP participants ; 31 ( 89 % ) cABC and 16 ( 94 % ) cNVP isolates had a week 96 FC below the biological cut-off for tenofovir ( 2.2 ) .


In the cNVP arm , 16/17 participants had resistance mutations synonymous with high-level resistance to nevirapine and efavirenz ; FC values for etravirine were above the biological cut-off in 9 ( 53 % ) isolates .


In multivariate regression models , K65R , Y115F and the presence of thymidine analogue-associated mutations were associated with increased susceptibility to etravirine in the cABC arm .


Our data support the use of tenofovir following failure of a first-line zidovudine-containing regimen and shed further light on non-nucleoside reverse transcriptase inhibitor hypersusceptibility .


Missed opportunities for human papilloma virus ( HPV ) vaccination are common , presenting a barrier to achieving widespread vaccine coverage and preventing infection .


To compare the impact of clinician - versus family-focused decision support , none , or both on captured opportunities for HPV vaccination .


Twelve-month cluster randomized controlled trial conducted in 2010-2011 .


Adolescent girls aged 11-17 years due for HPV Dose 1 , 2 , or 3 receiving care at primary care practices .


Twenty-two primary care practices were cluster randomized to receive a three-part clinician-focused intervention ( educational sessions , electronic health record-based alerts , and performance feedback ) or none .


Within each practice , girls were randomized at the patient level to receive family-focused , automated , educational phone calls or none .


Randomization resulted in four groups : clinician-focused , family-focused , combined , or no intervention .


Standardized proportions of captured opportunities ( due vaccine received at clinician visit ) were calculated among girls in each study arm .


Analyses were conducted in 2013 .


Among 17,016 adolescent girls and their 32,472 visits ( 14,247 preventive , 18,225 acute ) , more HPV opportunities were captured at preventive than acute visits ( 36 % vs 4 % , p < 0.001 ) .


At preventive visits , the clinician intervention increased captured opportunities by 9 percentage points for HPV-1 and 6 percentage points for HPV-3 ( p0 .01 ) , but not HPV-2 .


At acute visits , the clinician and combined interventions significantly improved captured opportunities for all three doses ( p0 .01 ) .


The family intervention was similar to none .


Results differed by practice setting ; at preventive visits , the clinician intervention was more effective for HPV-1 in suburban than urban settings , whereas at acute visits , the clinician intervention was more effective for all doses at urban practices .


Clinician-focused decision support is a more effective strategy than family-focused to prevent missed HPV vaccination opportunities .


Given the persistence of missed opportunities even in intervention groups , complementary strategies are needed .


This study is registered at clinicaltrials.gov NCT01159093 .


Short periods of muscle disuse , due to illness or injury , result in substantial skeletal muscle atrophy .


Recently , we have shown that a single session of neuromuscular electrical stimulation ( NMES ) increases muscle protein synthesis rates .


The aim was to investigate the capacity for daily NMES to attenuate muscle atrophy during short-term muscle disuse .


Twenty-four healthy , young ( 23 1 year ) males participated in the present study .


Volunteers were subjected to 5 days of one-legged knee immobilization with ( NMES ; n = 12 ) or without ( CON ; n = 12 ) supervised NMES sessions ( 40-min sessions , twice daily ) .


Two days prior to and immediately after the immobilization period , CT scans and single-leg one-repetition maximum ( 1RM ) strength tests were performed to assess quadriceps muscle cross-sectional area ( CSA ) and leg muscle strength respectively .


Furthermore , muscle biopsies were taken to assess muscle fibre CSA , satellite cell content and mRNA and protein expression of selected genes .


In CON , immobilization reduced quadriceps CSA by 3.5 0.5 % ( P < 0.0001 ) and muscle strength by 9 2 % ( P < 0.05 ) .


In contrast , no significant muscle loss was detected following immobilization in NMES although strength declined by 7 3 % ( P < 0.05 ) .


Muscle MAFbx and MuRF1 mRNA expression increased following immobilization in CON ( P < 0.001 and P = 0.07 respectively ) , whereas levels either declined ( P < 0.01 ) or did not change in NMES , respectively .


Immobilization led to an increase in muscle myostatin mRNA expression in CON ( P < 0.05 ) , but remained unchanged in NMES .


During short-term disuse , NMES represents an effective interventional strategy to prevent the loss of muscle mass , but it does not allow preservation of muscle strength .


NMES during disuse may be of important clinical relevance in both health and disease .


Compared with goal-directed crystalloid therapy , goal-directed colloid therapy during high-risk surgery may improve postoperative outcome .


Whether intraoperative fluid therapy based on goal-directed protocol with different types of fluid has distinctive effects on brain relaxation and cerebral metabolism during craniotomy remains unclear .


Forty patients with supratentorial brain tumors undergoing craniotomy were randomly assigned to either a Ringer 's Lactate-based goal-directed group ( LR group , n = 20 ) or a 6 % hydroxyethyl starch-based goal-directed group ( HES group , n = 20 ) .


The goal was achieved by maintaining a target stroke volume variation ( SVV < 13 % ) by volume loading with LR or HES throughout the procedure .


The primary outcome is brain relaxation scales , an indirect evaluation of ICP ; secondary endpoints include cerebral metabolism variables ( jugular venous oxygen saturation [ SjvO ( 2 ) ] , arterial-jugular venous differences in oxygen [ CajvO ( 2 ) ] , glucose [ A-JvGD ] , lactate [ A-JvLD ] , and cerebral extraction ratio for oxygen [ CERO ( 2 ) ] ) and fluid volumes .


There is no significant difference between the LR and HES groups on brain relaxation scales ( P = 0.845 ) , or measures of cerebral oxygenation and metabolism .


Intragroup comparisons showed that CERO ( 2 ) increased by 14.3 % ( P = 0.009 , LR group ) and 13.2 % ( P = 0.032 , HES group ) , respectively , and SjvO ( 2 ) was decreased by 8.8 % ( P = 0.016 , LR group ) and 8.1 % ( P = 0.026 , HES group ) , respectively , after tumor removal , compared with baseline .


During surgery , the LR group ( 30701138 mL ) received more fluid than the HES group ( 2041758 mL , P = 0.002 ) .


In patients undergoing supratentorial tumor resection , goal-directed HES therapy was not superior to goal-directed LR therapy for brain relaxation or cerebral metabolism , although less fluid was needed to maintain the target SVV in the HES-based group than in the LR-based group .


Clefting of the lip , palate , or both is a common congenital abnormality .


Inadequate treatment for pain in children may result from concerns over opioid-related adverse effects .


Providing adequate pain control with minimal adverse effects remains challenging in children .


To assess opioid-sparing effects of oral or intravenous acetaminophen following primary cleft palate repair in children .


Prospective randomized controlled trial in 45 healthy children , ages 5months to 5years , using standardized general anesthesia and lidocaine infiltration of the operative field .


Patients were allocated to groups : intravenous acetaminophen/oral placebo ( intravenous ) , oral acetaminophen/intravenous placebo ( oral ) , or intravenous/oral placebo ( control ) .


Groups were compared for differences in opioid administration during the 24-h study period ( morphine equivalents gkg ( -1 ) ; 95 % confidence interval ) .


Intravenous acetaminophen decreased opioid requirement after surgery ( P = 0.003 ) .


Patients in the intravenous group received less opioid ( 272.9 ; 202.9-342 .8 gkg ( -1 ) ) than control patients ( 454.2 ; 384.3-524 .2 gkg ( -1 ) ; P < 0.002 ) .


Opioid requirement in oral patients ( 376.5 ; 304.1-448 .9 gkg ( -1 ) ) was intermediate and not significantly different from either intravenous ( P = 0.11 ) or control ( P = 0.27 ) .


During the ward phase of care , intravenous had better analgesia than control ( P = 0.002 ) , and both intravenous and oral group patients received less opioid than control ( P = 0.01 ) .


Intravenous acetaminophen given to young children undergoing primary cleft palate repair was associated with opioid-sparing effects compared to placebo .


The fewer morphine doses during ward stay in both intravenous and oral may be important clinically in some settings .


The aim of the study was to evaluate the durability of efficacy of the Integrated Care ( IC ) program in a Swedish context .


The IC program is a person-centered flexible assertive community treatment approach delivered through a novel mechanism : a resource group clinical microsystem for each patient .


All patients with schizophrenia in a Gothenburg urban-sector catchment area were randomly assigned to either the IC or the Rational Rehabilitation ( RR ) programs .


Sixty-six patients were interviewed and assessed by independent interviewers before treatment , after treatment ( 24 months ) , and at follow-up ( five years ) .


Analysis was by intention to treat .


At the five-year follow-up , significant improvements were noted in social functioning and consumer satisfaction in the IC group ( N = 35 ) compared with the RR group ( N = 31 ) .


No patients were lost to services in either program .


The major finding was the durability of efficacy of the IC program .


Statins are known to possess pleiotropic anti-inflammatory properties which have been evaluated for clinical benefits in a number of disorders .


Studies have demonstrated beneficial actions of statins in experimental models of colitis .


Clinical evidence in acute exacerbation of ulcerative colitis ( UC ) is lacking .


This study aims to assess the efficacy and safety of add-on atorvastatin in mild to moderately severe acute exacerbation of UC .


Patients with acute exacerbation of UC were randomized to receive either atorvastatin ( 20 mg ) or matching placebo once daily orally for 8 weeks in addition to the standard therapy .


Clinical efficacy was assessed by using partial Mayo score ( PMS ) .


Previously diagnosed 64 cases of UC presenting with mild to moderately severe acute exacerbation were randomized to receive either atorvastatin of 20 mg or placebo .


Mean PMS increased by 1.5 points and decreased by 0.31 points in atorvastatin and placebo groups , respectively , at 8 weeks compared to the baseline values ( p = 0.04 ) .


Eight ( 25 % ) and 13 ( 40.6 % ) patients attained the primary outcome criteria for clinical improvement in the atorvastatin and placebo arms , respectively ( p = 0.18 ) .


Fifteen ( 46.8 % ) patients in the atorvastatin group and no patient in the placebo group had 2 point increase in PMS after 8 weeks ( p < 0.001 ) .


Atorvastatin therapy in acute exacerbation of UC may not be associated with beneficial effects .


Paradoxical increase in disease activity may be seen in some patients .


However , these findings need to be substantiated in larger studies .


The high prevalence of sleep disorders highlights the importance of its treatment in hemodialysis patients .


Due to complications of hypnotic medications , considering effective nonpharmacological methods to improve sleep quality is important .


This study has conducted to determine the effect of a sleep hygiene training program on sleep quality of hemodialysis patients .


In a randomized controlled clinical trial , 82 hemodialysis patients were randomly selected and allocated to the intervention ( n = 41 ) and control ( n = 41 ) groups .


A 1-month sleep hygiene program was provided to the intervention group within 6 sessions , and the sleep quality was assessed by the Pittsburgh Sleep Quality Index before and after the intervention .


The global and components scores were compared between the two groups .


The mean global scores and component scores of sleep quality were not significantly different between the two groups before the intervention .


The mean global score of sleep quality of the intervention group significantly reduced after sleep hygiene education , as compared to the baseline values .


The mean global score of the intervention group was significantly lower than that of the control group after the intervention ( intervention , 9.92 + / - 3.80 versus control , 13.05 + / - 4.28 ) .


Also , the mean scores subjective sleep quality , sleep latency , sleep disturbances , and daytime dysfunction were significantly lower in the intervention group .


The findings of this study suggest that nursing and physicians team should consider reducing sleep problems of hemodialysis patients by training sleep hygiene .


Decision aids may improve informed consent in clinical trial recruitment , but have not been evaluated in this context .


This study investigated whether decision aids ( DAs ) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II ( IBIS-II ) trial .


The IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts : women with increased risk ( Prevention ) , and women treated for ductal carcinoma in situ ( DCIS ) .


Australia , New Zealand and United Kingdom participants were randomised to receive a DA ( DA group ) or standard trial consent materials ( control group ) .


Questionnaires were completed after deciding about participation in IBIS-II ( post decision ) and 3 months later ( follow-up ) .


Data from 112 Prevention and 34 DCIS participants were analysed post decision ( 73 DA ; 73 control ) ; 95 Prevention and 24 DCIS participants were analysed at follow-up ( 58 DA ; 61 control ) .


There was no effect on the primary outcome of decisional conflict .


The DCIS-DA group had higher knowledge post decision , and the Prevention-DA group had lower decisional regret at follow-up .


This was the first study to evaluate a DA in the clinical trial setting .


The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation .


This randomized , single center , examiner-blind , controlled , parallel-group , 6-month clinical study compared the antiplaque/antigingivitis potential of an essential oil ( EO ) versus a 0.07 % cetylpyridinium chloride ( CPC ) - containing mouthrinse .


A 5 % hydroalcohol solution was included as a control group .


354 healthy volunteers ( 18-71 years of age ) were enrolled in this clinical trial ; 338 subjects completed the study .


At baseline , 1 - , 3 - , and 6-month visits , subjects received an oral examination , gingivitis ( MGI ) , gingival bleeding ( BI ) and plaque assessments ( PI ) .


Following randomization , subjects received a prophylaxis and began brushing twice daily with the provided fluoride toothpaste and rinsing twice daily with 20 mL of the assigned mouthrinse for 30 seconds .


All rinses were well tolerated by the subjects , with the exception of extrinsic tooth stain complaints in 13 subjects in the CPC group between the 3 - and 6-month exams .


Statistically significant reductions in gingivitis , bleeding and plaque were observed for both EO and CPC at all post-baseline time-points when compared to the negative control .


At 6 months MGI and PI were reduced by 42.6 % and 42.0 % for EO and by 17.1 % and 13.9 % respectively , for CPC vs. control .


When compared to CPC , EO was statistically significantly superior at all post-baseline time-points .


EO showed increasing reductions in MGI of 10.5 % , 20.3 % and 30.7 % as well as reductions in PI of 12.7 % , 23.7 % and 32.6 % at 1 , 3 and 6 months , respectively .


When analyzing the number of healthy sites ( MGI scores of 0 or 1 ) , the beneficial effect of the EO-containing mouthrinse is 45.8 % greater than using a CPC-containing mouthrinse and 59.8 % greater than placebo .


Genome-wide association studies identified that insulin-like growth factor 2 mRNA-binding protein 2 ( IGF2BP2 ) genetic polymorphisms are related to type 2 diabetes mellitus ( T2DM ) in several populations .


This study aimed to investigate whether the IGF2BP2 gene rs1470579 and rs4402960 polymorphisms were associated with T2DM and pioglitazone efficacy in Chinese T2DM patients .


A total of 281 T2DM patients and 111 healthy volunteers were enrolled to identify the IGF2BP2 gene rs1470579 and rs4402960 polymorphisms ; 86 patients were randomly selected and given a 12-week pioglitazone treatment ( 30 mg/day ) .


Fasting plasma glucose , postprandial plasma glucose ( PPG ) , glycated hemoglobin , serum triglycerides ( TG ) , total cholesterol , low-density lipoprotein cholesterol and high-density lipoprotein cholesterol ( HDL-C ) were determined before and after pioglitazone treatment .


The results showed that the IGF2BP2 gene rs1470579 and rs4402960 polymorphisms were associated with T2DM in a Chinese population ( OR = 2.002 , 95 % CI 1.170-3 .426 , p < 0.05 ; OR = 1.879 , 95 % CI 1.110-3 .182 , p < 0.05 ) .


The effect of pioglitazone on PPG ( p < 0.05 ) , TG ( p < 0.01 ) and HDL-C ( p < 0.05 ) was lower in patients with the rs1470579 AC+CC genotypes than in AA genotype carriers .


Its effect on PPG level was also lower in patients with the GT+TT genotypes of rs4402960 than in patients with the GG genotype ( p < 0.05 ) .


The IGF2BP2 gene rs1470579 and rs4402960 polymorphisms were associated with T2DM and therapeutic efficacy of pioglitazone in this Chinese population .


The aim of this study was to evaluate the efficacy and safety of zoledronic acid ( ZA ) in the combination of docetaxel-based chemotherapy for castration-resistant prostate cancer with bone metastases .


We conducted a prospective study in recruiting 105 prostate cancer patients with bone metastases from 2008 to 2010 .


Patients were randomly divided into two groups , 53 in the docetaxel-based chemotherapy + ZA ( Group A ) and 52 in the docetaxel-based chemotherapy + placebo ( Group B ) .


The different outcome between patients treated with chemotherapy combined with ZA and those with chemotherapy alone was evaluated .


The Cox multivariate analyses of clinical features and different treatment methods of the 105 patients were conducted .


There was a response of prostate-specific antigen ( PSA ) in 33 ( 62.3 % ) in Group A and 28 ( 53.8 % ) in Group B ( P = 0.20 ) .


The combined approach group had better bone progression-free survival ( BPFS ) ( 9.0 vs. 6.0 months , P < 0.05 ) and overall survival ( OS ) ( 19.0 vs. 15.0 months , P = 0.02 ) , but no statistical evidence of benefit was observed in terms of PSA response .


Cox multivariate analysis identified the following independent prognostic factors : received ZA , high Hb level and more than 6 cycles of chemotherapy .


There were no clinical relevant differences in the frequencies of adverse events between these two groups .


Zoledronic acid treatment combined with docetaxel-based chemotherapy could have a better bone pain control and improve BPFS and OS for prostate cancer patients with bone metastases .


The PSA response and SREs rate are similar .


The aim of this study was to examine the effects of testosterone on verbal learning and memory in postmenopausal women .


Randomized , placebo-controlled trial in which participants were randomized ( 1:1 ) to transdermal testosterone gel 300mcg/day , or identical placebo , for 26weeks .


Ninety-two postmenopausal women aged 55-65years , on no systemic sex hormone therapy .


The primary outcome was the score for the International Shopping List Task ( ISLT ) of CogState .


Secondary outcomes included other CogState domains , the Psychological General Well-Being Index ( PGWB ) and safety variables .


Eighty-nine women , median age 60years , were included in the primary analysis .


Testosterone treatment resulted in statistically significantly better performance for the ISLT ( improved verbal learning and memory ) compared with placebo , adjusted for age and baseline score ( mean difference 157 ; 95 % CI 013 , 301 ) P = 003 ) .


There were no significant differences for other CogState domains or the PGWB scores .


At 26weeks , the median total testosterone was 17nm ( interquartile range ( IQR ) 11 , 24 ) in the testosterone group and 04nm ( IQR 03 , 05 ) in the placebo group .


The small but statistically significant effect of testosterone treatment on verbal learning and memory in postmenopausal women provides the basis for further clinical trials .


The objective was to determine the effect of preconception-initiated daily low-dose aspirin ( LDA ; 81 mg/day ) treatment on time to pregnancy in women with a history of pregnancy loss .


This was a multicenter , block-randomized , double-blind , placebo-controlled trial .


Participants were block-randomized by center and eligibility stratum .


The study was conducted at four U.S.A. medical centers ( 2007-2012 ) .


Participants women aged 18-40 years actively attempting pregnancy , stratified by eligibility criteria : the `` original '' stratum , women with one loss < 20 weeks ' gestation during the previous year ; and the `` expanded '' stratum , women with one or two previous losses of any gestational age regardless of time since loss .


Daily LDA was compared with matching placebo for up to six menstrual cycles of attempting pregnancy .


Time to hCG detected pregnancy and clinically confirmed pregnancy , analyzed by intention-to-treat , was measured .


Of the 1228 women randomly assigned to LDA ( n = 615 ) or placebo ( n = 613 ) , 410 ( 67 % ) women receiving LDA achieved pregnancy compared to 382 ( 63 % ) receiving placebo , corresponding to a fecundability odds ratio ( FOR ) of 1.14 ( 95 % CI : 0.97 , 1.33 ) .


Among women in the original stratum ( n = 541 ) , LDA was associated with increased fecundability compared to placebo ( FOR : 1.28 ; 95 % CI : 1.02 , 1.62 ) .


Preconception-initiated LDA treatment resulted in a nonsignificant increase in fecundability of 14 % in women with a history of 1-2 pregnancy losses , and a significant increase of 28 % in women with a history of only one pregnancy loss of < 20 weeks ' gestation in the preceding year .


Preconception-initiated LDA may increase fecundability in certain women with a recent early pregnancy loss .


Amrubicin , a third-generation anthracycline and potent topoisomerase II inhibitor , showed promising activity in small-cell lung cancer ( SCLC ) in phase II trials .


This phase III trial compared the safety and efficacy of amrubicin versus topotecan as second-line treatment for SCLC .


A total of 637 patients with refractory or sensitive SCLC were randomly assigned at a ratio of 2:1 to 21-day cycles of amrubicin 40 mg/m ( 2 ) intravenously ( IV ) on days 1 to 3 or topotecan 1.5 mg/m ( 2 ) IV on days 1 to 5 .


Primary end point was overall survival ( OS ) ; secondary end points included overall response rate ( ORR ) , progression-free survival ( PFS ) , and safety .


Median OS was 7.5 months with amrubicin versus 7.8 months with topotecan ( hazard ratio [ HR ] , 0.880 ; P = .170 ) ; in refractory patients , median OS was 6.2 and 5.7 months , respectively ( HR , 0.77 ; P = .047 ) .


Median PFS was 4.1 months with amrubicin and 3.5 months with topotecan ( HR , 0.802 ; P = .018 ) .


ORR was 31.1 % with amrubicin and 16.9 % with topotecan ( odds ratio , 2.223 ; P < .001 ) .


Grade 3 treatment-emergent adverse events in the amrubicin and topotecan arms were : neutropenia ( 41 % v 54 % ; P = .004 ) , thrombocytopenia ( 21 % v 54 % ; P < .001 ) , anemia ( 16 % v 31 % ; P < .001 ) , infections ( 16 % v 10 % ; P = .043 ) , febrile neutropenia ( 10 % v 3 % ; P = .003 ) , and cardiac disorders ( 5 % v 5 % ; P = .759 ) ; transfusion rates were 32 % and 53 % ( P < .001 ) , respectively .


NQO1 polymorphisms did not influence safety outcomes .


Amrubicin did not improve survival when compared with topotecan in the second-line treatment of patients with SCLC .


OS did not differ significantly between treatment groups , although an improvement in OS was noted in patients with refractory disease treated with amrubicin .


Essential hypertension is frequently associated with hyperuricemia in both adult and pediatric patients .


Lowering serum uric acid level may provide greater benefit than simply treating hypertension .


Forty-four adolescents , aged 12-19years , newly diagnosed as essential hypertension ( secondary hypertension was excluded ) and previously untreated were randomized ( open label trial ) to receive either enalapril or enalapril plus allopurinol in combination .


All participants had baseline serum uric acid level 5.5 mg/dl .


Baseline mean blood pressure ( BP ) , age and body mass index were similar between the two groups .


After 8weeks ' treatment , BP reduction was greater , percent of treatment group achieving target BP level was greater , and serum uric acid level was lower in the combination treatment group .


There were no adverse effects during the course of therapy .


Results suggest that uric acid reduction may be used as adjunctive antihypertensive therapy in hypertensive adolescents with hyperuricemia while closely monitoring for any adverse effect .


To investigate the effect of rhubarb combined with early enteral nutrition ( EEN ) on the gastrointestinal function , disease severity and systemic inflammation in patients with severe acute pancreatitis ( SAP ) .


A total of 126 patients with SAP were randomly assigned into three groups : parenteral nutrition group , treated with standard solution first and EN 14 days later ; EEN group , treated with EN suspension ; or EEN combined with rhubarb group , treated with rhubarb and then EN 2 h later .


The gastrointestinal function , APACHE II scores , the levels of plasma IL-6 , IL-11 , C-reactive proteins ( CRP ) and the liver and kidney functional measures were longitudinally analyzed .


Patients in the EEN/rhubarb group had the shortest period of abdominal pain and the fastest recovery from abnormal bowel movement and high fever as well as significantly shorter periods of intensive-care unit and hospital stays .


The combination of EEN and rhubarb significantly reduced the values of APACHE II scores .


Combination therapies significantly reduced abnormally higher white blood cell ( WBC ) counts and levels of plasma CRP and IL-6 , but increased the levels of plasma IL-11 .


Finally , combination therapies improved the SAP-related damages of liver and kidney function by reducing abnormally higher levels of plasma alanine aminotransferase , aspartate aminotransferase , and creatinine ( Cr ) .


Combination of EEN and rhubarb significantly improved the gastrointestinal function , inhibited systemic inflammation and disease severity and mitigated the disease-related damages of liver and kidney function in SAP patients .


Postoperative pain control constitutes a major problem and studies have focused on reducing opioid requirements using regional techniques .


We aimed to investigate the efficacy of wound infiltration with lornoxicam on postoperative pain control following thyroidectomy .


In this prospective , randomized-controlled study , 80 patients scheduled for thyroidectomy were randomly assigned to 2 groups .


After the thyroidectomy was performed , patients in group I underwent wound infiltration with 4 mg of lornoxicam and patients in group II received the same amount of saline .


Rescue analgesia was provided with additional doses oflornoxicam delivered by an on-demand patient-controlled analgesia device .


Total analgesic consumption during the postoperative 24 h , and pain intensities assessed using a visual analog scale score at 0 , 2 , 4 , 8 , 12 and 24 h postoperatively were recorded .


Pain scores during the postoperative 24 h were slightly lower in group I than in group II , but the difference was not significant ( P > 0.05 ) .


The mean analgesic consumption was 8.87 1.87 mg and 10.33 1.25 mg in groups I and II , respectively ( P > 0.05 ) .


Wound infiltration with lornoxicam neither improved postoperative pain control nor decreased total analgesic consumption .


The objective of this study was to determine the effect of inspiratory resistance through an impedance threshold device ( ITD ) on orthostatic tolerance in patients with postural tachycardia syndrome .


We hypothesized that the ITD would result in a greater negative intrathoracic pressure to enhance cardiac venous return , improve stroke volume , and reduce heart rate in these patients .


We compared the effect of a sham device ( sham , no resistance ) versus an ITD ( increased inspiratory resistance ) in 26 patients with postural tachycardia syndrome in a randomized , single-blind , crossover study .


Hemodynamic assessments were performed at baseline while supine and during head-up tilt to 70 for 10 minutes .


We did not find differences in baseline hemodynamic parameters between the ITD and the sham devices .


After 10 minutes of head-up tilt , the heart rate was lower with the ITD versus sham device ( 1024 versus 1094 beat/min , respectively ; P = 0.003 ) .


The ITD also improved stroke volume compared with the sham device ( 352 versus 261 mL ; P = 0.006 ) .


These findings suggest that increasing negative intrathoracic pressure with ITD breathing improves heart rate control in patients with postural tachycardia syndrome during upright posture .


clinicaltrials.gov ; Unique Identifier : NCT00962728 .


This prospective , randomized , single-centre study compared peginterferons alfa-2a and alfa-2b , combined with ribavirin , in treating patients infected with hepatitis C virus ( HCV ) genotype 1 .


Hundred-and-one patients received 48 weeks of open-label treatment with peginterferon alfa-2a ( 180 g/week ) and 111 patients received peginterferon alfa-2b ( 1.5 g/kg/week ) .


All patients received the same dose of ribavirin 1000/1200 mg/day , depending on weight .


The primary efficacy endpoint was sustained virologic response ( SVR ) , defined as undetectable HCV RNA ( < 50 IU/mL ) 24 weeks after the end of treatment .


Early virologic response ( EVR ) , defined as at least 2 log IU/mL reduction of viral load at 12 weeks , was more common in patients treated with peginterferon alfa-2a ( 88 % vs. 74.8 % ; p = 0.04 ) .


However , the difference in SVR was not statistically significant ( 49.5 % vs. 44.1 % ; p = 0.43 ) .


Peginterferon alfa-2a treated patients were also more likely to be HCV RNA negative at the end of treatment ( 67.3 % vs. 57.7 % ) , but this difference did not reach statistical significance .


Multivariate logistic regression analysis found that SVR was associated with low fibrosis stage ( F1-2 by Scheuer ; p = 0.001 ) and low serum HCV RNA level ( < 400,000 IU/L ; p = 0.023 ) .


While both forms of peginterferon showed similar efficacy as measured by SVR , use of peginterferon alfa-2b could lower the number of patients receiving unnecessary treatment beyond 12 weeks .


Trigger digit is one of the most common causes of pain and disability in the hand .


The mainstay of conservative treatment of this disease has been local steroid injection into the tendon sheath .


The aim of this study was to investigate the clinical benefit of an ultrasound-guided corticosteroid injection compared to a blinded application .


74 patients , who suffered from persistent or increasing symptoms of a single trigger digit , were enroled in this prospective , randomised case-control study .


All patients were treated with an injection of 40 mg/1 ml methylprednisolone acetate into the flexor tendon sheath at the level of the A1 pulley .


Half of the patients had their injections under ultrasound control ( USG ) and half without ( blinded injection group , BIG ) .


Associated metabolic diseases were recorded .


At the 6-week and 6-month follow-up examinations , the complication rate and the need for a second injection were assessed .


The outcome was rated using the Quinnell grading .


The pain level was assessed using the visual analogue scale .


Four patients were excluded due to lack of follow-up .


Both study groups were comparable in respect of age , hand dominance and associated diseases .


There were significantly more female patients in the USG group ( 32 versus 23 % ) .


After the corticosteroid injections , all patients improved significantly in terms of pain level and the Quinnell grading at 6 weeks and 6 months after the intervention in comparison to the pre-injection status .


There were no significant differences between the groups .


9 patients ( 13 % ) needed a second injection ( 6 of BIG , 3 of USG ) , all of whom had diabetes mellitus .


No local complications were seen after the injections .


The use of ultrasound-guided injection of corticosteroid may be associated with extra time and effort , with no superior clinical benefits compared to the blinded technique .


Level 1 ( prospective randomised study ) .


To assess changes in Ocular Response Analyzer ( ORA ) waveforms after UVA/riboflavin corneal collagen cross-linking ( CXL ) using investigator-derived and manufacturer-supplied morphometric variables in patients with keratoconus ( KC ) and postrefractive surgery ectasia .


Prospective randomized trial of a standard epithelium-off CXL protocol .


Patients with progressive KC ( 24 eyes of 21 patients ) or postrefractive surgery ectasia ( 27 eyes of 23 patients ) were enrolled .


Replicate ORA measurements were obtained before and 3 months after CXL .


Pretreatment and posttreatment waveform variables were analyzed for differences by paired Student t tests using measurements with the highest waveform scores .


Corneal hysteresis , corneal resistance factor , 37-s generation manufacturer-supplied ORA variables , and 15 investigator-derived ORA variables .


No variables were significantly different 3 months after CXL in the KC group , and no manufacturer-supplied variables changed significantly in the postrefractive surgery ectasia group .


Four custom variables ( ApplanationOnsetTime , P1P2avg , Impulse , and Pmax ) increased by small but statistically significant margins after CXL in the postrefractive surgery ectasia group .


Changes in a small subset of investigator-derived variables suggested an increase in corneal bending resistance after CXL .


However , the magnitudes of these changes were low and not commensurate with the degree of clinical improvement or prior computational estimates of corneal stiffening in the same cohort over the same period .


Available air-puff-derived measures of the corneal deformation response underestimate the biomechanical changes produced by CXL .


Denosumab 60 mg sc injection every 6 months for 36 months was well tolerated and effective in reducing the incidence of vertebral , nonvertebral , and hip fracture in predominantly Caucasian postmenopausal women with osteoporosis .


The objective of this phase 3 fracture study was to examine the antifracture efficacy and safety of denosumab 60 mg in Japanese women and men with osteoporosis compared with placebo .


A randomized , double-blind , placebo-controlled trial with an open-label active comparator as a referential arm was conducted .


Subjects were 1262 Japanese patients with osteoporosis aged 50 years or older , who had one to four prevalent vertebral fractures .


Subjects were randomly assigned to receive denosumab 60 mg sc every 6 months ( n = 500 ) , placebo for denosumab ( n = 511 ) , or oral alendronate 35 mg weekly ( n = 251 ) .


All subjects received daily supplements of calcium and vitamin D.


The primary endpoint was the 24-month incidence of new or worsening vertebral fracture for denosumab vs placebo .


Denosumab significantly reduced the risk of new or worsening vertebral fracture by 65.7 % , with incidences of 3.6 % in denosumab and 10.3 % in placebo at 24 months ( hazard ratio 0.343 ; 95 % confidence interval 0.194-0 .606 , P = .0001 ) .


No apparent difference in adverse events was found between denosumab and placebo during the first 24 months of the study .


These results provide evidence of the efficacy and safety of denosumab 60 mg sc every 6 months in Japanese subjects with osteoporosis .


To determine whether inoculation of healthy dogs with a recombinant peptide containing 3 copies of ACTH would result in the production of antibodies against ACTH and whether this would affect pituitary-adrenocortical function .


8 healthy dogs .


A recombinant peptide consisting of 3 copies of ACTH fused to a T-helper cell epitope was produced in Escherichia coli .


The protein was inoculated into 4 dogs at 4-week intervals ( total of 3 inoculations/dog ) .


Four control dogs received inoculations of PBS solution mixed with adjuvant .


Blood samples were collected for determination of antibody titers against ACTH and for measurement of basal and ACTH-stimulated plasma cortisol concentrations .


Inoculation with the ACTH vaccine resulted in production of anti-ACTH antibodies in all 4 dogs .


Titers were initially high but declined by 15 weeks after the initial inoculation .


Basal cortisol concentrations were unaffected by inoculation with the ACTH vaccine .


Plasma cortisol concentrations in response to ACTH stimulation were reduced at 12 weeks , but not at 15 weeks , after the first inoculation .


Inoculation of dogs with a recombinant ACTH vaccine resulted in the production of antibodies against the hormone .


Anti-ACTH titers were initially high but were not sustained .


The only detectable endocrine effect in treated dogs was a reduction in cortisol concentration in response to ACTH stimulation in 2 of 4 dogs at 12 weeks after the first inoculation .


The effect of vaccine administration on the pituitary-adrenal system was subtle and transient .


Many patients on maintenance dialysis experience significant sleepiness and fatigue .


However , the influence of the hemodialysis ( HD ) day and circadian rhythms on patients ' symptoms have not been well characterized .


We sought to use ecological momentary assessment to evaluate day-to-day and diurnal variability of fatigue , sleepiness , exhaustion and related symptoms in thrice-weekly maintenance HD patients .


Subjects used a modified cellular phone to access an interactive voice response system that administered the Daytime Insomnia Symptom Scale ( DISS ) .


The DISS assessed subjective vitality , mood , and alertness through 19 questions using 7 - point Likert scales .


Subjects completed the DISS 4 times daily for 7 consecutive days .


Factor analysis was conducted and a mean composite score of fatigue-sleepiness-exhaustion was created .


Linear mixed regression models ( LMM ) were used to examine the association of time of day , dialysis day and fatigue , sleepiness , and exhaustion composite scores .


The 55 participants completed 1,252 of 1,540 ( 81 % ) possible assessments over the 7 day period .


Multiple symptoms related to mood ( e.g. , feeling sad , feeling tense ) , cognition ( e.g. , difficulty concentrating ) , and fatigue ( e.g. , exhaustion , feeling sleepy ) demonstrated significant daily and diurnal variation , with higher overall symptom scores noted on hemodialysis days and later in the day .


In factor analysis , 4 factors explained the majority of the observed variance for DISS symptoms .


Fatigue , sleepiness , and exhaustion loaded onto the same factor and were highly intercorrelated .


In LMM , mean composite fatigue-sleepiness-exhaustion scores were associated with dialysis day ( coefficient and 95 % confidence interval [ CI ] 0.21 [ 0.02 - 0.39 ] ) and time of day ( coefficient and 95 % CI 0.33 [ 0.25 - 0.41 ] .


Observed associations were minimally affected by adjustment for demographics and common confounders .


Maintenance HD patients experience fatigue-sleepiness-exhaustion symptoms that demonstrate significant daily and diurnal variation .


The variability in symptoms may contribute to poor symptom awareness by providers and greater misclassification bias of fatigue related symptoms in clinical studies .


Endometrial adenocarcinoma ( EC ) is the most common gynaecologic cancer .


Up to 90 % of EC patients are obese which poses a health threat to patients post-treatment .


Standard treatment for EC includes hysterectomy , although this has significant side effects for obese women at high risk of surgical complications and for women of childbearing age .


This trial investigates the effectiveness of non-surgical or conservative treatment options for obese women with early stage EC .


The primary aim is to determine the efficacy of : levonorgestrel intrauterine device ( LNG-IUD ) ; with or without metformin ( an antidiabetic drug ) ; and with or without a weight loss intervention to achieve a pathological complete response ( pCR ) in EC at six months from study treatment initiation .


The secondary aim is to enhance understanding of the molecular processes and to predict a treatment response by investigating EC biomarkers .


An open label , three-armed , randomised , phase-II , multi-centre trial of LNG-IUD metformin weight loss intervention .


165 participants from 28 centres are randomly assigned in a 3:3:5 ratio to the treatment arms .


Clinical , quality of life and health behavioural data will be collected at baseline , six weeks , three and six months .


EC biomarkers will be assessed at baseline , three and six months .


There is limited prospective evidence for conservative treatment for EC .


Trial results could benefit patients and reduce health system costs through a reduction in hospitalisations and through lower incidence of adverse events currently observed with standard treatment .


To compare the cost-effectiveness of three types of follow-up for outpatients with stable low-activity rheumatoid arthritis ( RA ) .


In total , 287 patients were randomized to either planned rheumatologist consultations , shared care without planned consultations , or planned nurse consultations .


Effectiveness measures included disease activity ( Disease Activity Score based on 28 joint counts and C-reactive protein , DAS28-CRP ) , functional status ( Health Assessment Questionnaire , HAQ ) , and health-related quality of life ( EuroQol EQ-5D ) .


Cost measures included activities in outpatient clinics and general practice , prescription and non-prescription medicine , dietary supplements , other health-care resources , and complementary and alternative care .


Measures of effectiveness and costs were collected by self-reported questionnaires at inclusion and after 12 and 24 months .


Incremental cost-effectiveness rates ( ICERs ) were estimated in comparison with rheumatologist consultations .


Changes in disease activity , functional status , and health-related quality of life were not statistically significantly different for the three groups , although the mean scores were better for the shared care and nurse care groups compared with the rheumatologist group .


Shared care and nurse care were non-significantly less costly than rheumatologist care .


As both shared care and nurse care were associated with slightly better EQ-5D improvements and lower costs , they dominated rheumatologist care .


At EUR 10,000 per quality-adjusted life year ( QALY ) threshold , shared care and nurse care were cost-effective with more than 90 % probability .


Nurse care was cost-effective in comparison with shared care with 75 % probability .


Shared care and nurse care seem to cost less but provide broadly similar health outcomes compared with rheumatologist outpatient care .


However , it is still uncertain whether nurse care and shared care are cost-effective in comparison with rheumatologist outpatient care .


Methotrexate is a commonly used anti-inflammatory and immunosuppressive drug .


There is growing evidence that inflammatory processes are involved in the pathogenesis of schizophrenia .


In our recent randomised double-blind placebo-controlled clinical trial in Pakistan and Brazil , the addition of minocycline ( antibiotic and anti-inflammatory drug ) for 1year to treatment as usual reduced negative symptoms and improved some cognitive measures .


A meta-analysis of cytokine changes in the peripheral blood has identified IL-2 , IFN-gamma , TNF-alpha and soluble IL-2 receptor as trait markers of schizophrenia because their levels were elevated during acute exacerbations and reduced in remission .


This suggests immune activation and an inflammatory syndrome in schizophrenia .


Based on the evidence of the strong anti-inflammatory properties of methotrexate , we propose that low-dose methotrexate may be an effective therapy in early schizophrenia .


This is a double-blind placebo-controlled study of methotrexate added to treatment as usual for patients suffering from schizophrenia , schizoaffective disorder , psychosis not otherwise specified or schizophreniform disorder .


This will be with 72 patients , 36 in each arm over 3months .


There will be screening , randomisation and follow-up visits .


Full clinical assessments will be carried out at baseline , 2 , 4 , 8 and 12weeks .


Social and cognitive assessments will be carried out at baseline and 12weeks .


Methotrexate will be given at a dose of 10 mgs orally once a week for a 3-month period .


Evidence suggests inflammatory processes are involved in the pathogenesis of schizophrenia and anti-inflammatory treatments have shown to have some beneficial effects .


Methotrexate is a known immunosuppressant and anti-inflammatory drug .


The aim of this study is to establish the degree of improvement in positive and negative symptoms , as well as cognitive functioning with the addition of methotrexate to treatment as usual.ClinicalTrials.gov identifier : NCT02074319 ( 24 February 2014 ) .


The role of bony pelvic anomalies in bladder exstrophy is long established and has generated many papers addressing walking problems .


Biomechanical studies and kinematic gait analysis were performed on very young children .


A direct kinetic gait evaluation has never been performed , nor has the effect of pelvis dimorphism on the upper body been studied .


Controlled experimental study .


Outpatients were studied at the time of periodic follow up .


Nineteen patients with bladder exstrophy , age 148 years , and twenty-five healthy control participants , age 158 years , were enrolled in the present gait analysis study .


Clinical evaluation and standard gait analysis were performed .


Gait analysis deviations between exstrophy patients and controls and between patients that received pelvic osteotomy ( OT -- 6 patients ) and those that did not ( no-OT -- 13 patients ) were analyzed .


Bladder exstrophy significantly affects kinematics and kinetics of trunk , spine , pelvis , knee and foot ; in particular : in OT , trunk retroversion , pelvic retroversion and rotation , hip adduction angle and moment , knee flexion and its maximum power during loading response increased , whereas in no-OT , spine angle , pelvic posterior tilt , hip extension , and the external rotation of the foot progression angle increased .


All the kinetics parameters analyzed in the study showed lower values in the patient group than in controls .


Walking in patients with bladder exstrophy is accomplished by retroversion of the pelvis and deviations mainly in the spine angle in no-OT and in knee flexion in OT .


Gait analysis was shown to be an effective tool for the detection of walking deviations that should be identified early , prompting rehabilitative treatment in order to prevent spine and knee diseases .


Maladaptive behaviors may be more fully understood and efficiently prevented by ambulatory tools that assess people 's ongoing experience in the context of their environment .


To demonstrate new field-deployable methods for assessing mood and behavior as a function of neighborhood surroundings ( geographical momentary assessment ; GMA ) , we collected time-stamped GPS data and ecological momentary assessment ( EMA ) ratings of mood , stress , and drug craving over 16 weeks at randomly prompted times during the waking hours of opioid-dependent polydrug users receiving methadone maintenance .


Locations of EMA entries and participants ' travel tracks calculated for the 12 before each EMA entry were mapped .


Associations between subjective ratings and objective environmental ratings were evaluated at the whole neighborhood and 12-h track levels .


Participants ( N = 27 ) were compliant with GMA data collection ; 3711 randomly prompted EMA entries were matched to specific locations .


At the neighborhood level , physical disorder was negatively correlated with negative mood , stress , and heroin and cocaine craving ( ps < .0001 -.0335 ) ; drug activity was negatively correlated with stress , heroin and cocaine craving ( ps .0009 -.0134 ) .


Similar relationships were found for the environments around respondents ' tracks in the 12h preceding EMA entries .


The results support the feasibility of GMA .


The relationships between neighborhood characteristics and participants ' reports were counterintuitive and counter-hypothesized , and challenge some assumptions about how ostensibly stressful environments are associated with lived experience and how such environments ultimately impair health .


GMA methodology may have applications for development of individual - or neighborhood-level interventions .


In single-incision laparoscopic surgery ( SILS ) , operating through 1 incision presents ergonomic challenges .


No consensus exists on whether articulating instruments ( ARTs ) may help .


This study evaluated their effect on simulated SILS , hypothesizing that they would affect performance and workload .


Surgeons were randomized to 2 straight instruments ( STRs ) , 1 ART and 1 STR , or 2 ARTs .


After baseline testing , 25 repetitions of the Fundamentals of Laparoscopic Surgery ( FLS ) peg-transfer ( PEG ) task and 5 repetitions of the short-hand for the FLS pattern-cutting task ( CIRCLE ) were performed .


Primary outcomes were maximum FLS PEG scores , CIRCLE times and errors , and Imperial College Surgical Assessment Device hand motion analysis .


National Aeronautics and Space Administration ( NASA ) Raw Task Load Index ( RTLX ) questionnaires evaluated a secondary outcome -- workload .


The trial took place in a simulated operating theater within the Academic Surgical Unit at St Mary 's Hospital , London , UK .


Eligible surgeons had completed at least 5 laparoscopic cases as a primary operator .


Surgeons were stratified by laparoscopic experience into intermediate ( less than 25 previous procedures as primary operator ) or advanced ( 25 procedures or more ) .


A total of 21 surgeons were recruited and randomized ; 7 of them to each instrument combination group .


All surgeons completed PEG , and 5 from each group completed CIRCLE .


Groups ' baseline PEG scores were similar ( p = 0.625 ) .


STR-ART achieved higher maximum PEG scores than STR or ART did ( median = 236 vs 198 vs 193 , respectively , p = 0.002 ) .


Fastest CIRCLE times were similar ( median = 190s vs 130s vs 186s , p = 0.129 ) as were minimum errors ( median = 1 vs 2 vs 3 , p = 0.101 ) .


For PEG , Imperial College Surgical Assessment Device demonstrated similar total path lengths ( median = 12.3 m vs 12.3 m vs 16.0 m , p = 0.545 ) and total numbers of movements ( median = 89.6 vs 86.4 vs 171 , p = 0.080 ) .


Groups ' NASA Raw Task Load Index scores were similar ( p = 0.708 ) .


Combining 1 STR and 1 ART improved SILS performance in the PEG task .


Therefore , this may be the optimum instrument configuration for use within some clinical SILS applications .


We evaluated the effectiveness of a continuing medical education program , Physician Asthma Care Education , in improving pediatricians ' asthma therapeutic and communication skills and patients ' health care utilization for asthma .


We conducted a randomized trial in 10 regions in the United States .


Primary care providers were recruited and randomly assigned by site to receive the program provided by local faculty .


The program included 2 interactive seminar sessions ( 2.5 hours each ) that reviewed national asthma guidelines , communication skills , and key educational messages .


Format included short lectures , case discussions , and a video modeling communication techniques .


We collected information on parent perceptions of physicians ' communication , the child 's asthma symptoms , and patients ' asthma health care utilization .


We used multivariate regression models to determine differences between control and intervention groups .


A total of 101 primary care providers and a random sample of 870 of their asthma patients participated .


After 1 year , we completed follow-up telephone interviews with the parents of 731 of the 870 patients .


Compared to control subjects , parents reported that physicians in the intervention group were more likely to inquire about patients ' concerns about asthma , encourage patients to be physically active , and set goals for successful treatment .


Patients of physicians that attended the program had a greater decrease in days limited by asthma symptoms ( 8.5 vs 15.6 days ) , as well as decreased emergency department asthma visits ( 0.30 vs 0.55 visits per year ) .


The Physician Asthma Care Education program was used in a range of locations and was effective in improving parent-reported provider communication skills , the number of days affected by asthma symptoms , and asthma health care use .


Patients with more frequent asthma symptoms and higher health care utilization at baseline were more likely to benefit from their physician 's participation in the program .


There are few rigorous studies to confirm or refute the commonly cited concern that control of blood pressure to lower thresholds may result in an increased risk of falls and fractures .


To compare falls and fractures in participants with type 2 diabetes in the intensive ( targeting a systolic blood pressure of < 120 mmHg ) and standard ( targeting a systolic blood pressure of < 140 mmHg ) blood pressure control arms of the Action to Control Cardiovascular Risk in Diabetes ( ACCORD ) randomized trial ( N = 4,733 ) .


A subset of 3,099 participants self-reported annually on the occurrence of falls and non-spine fractures .


Fractures were centrally adjudicated .


The incidence of falls in the two treatment groups was compared using a random-effects negative binomial model , and fracture risk was compared using Cox proportional hazards models .


At enrollment in both groups , the mean age was 62 years , 44 % were women , 25 % were Black , and mean blood pressure was 138/75 mmHg .


During follow-up , all classes of medications , particularly thiazide diuretics , were more commonly prescribed in the intensive group .


After 1 year of follow-up , the mean systolic blood pressure was 13315 mmHg in the standard group and 11914 mmHg in the intensive group .


The adjusted rate of falls did not differ in the intensive and standard groups ( 62.2 / 100 person-years vs. 74.1 / 100 person-years , RR = 0.84 , 95 % CI 0.54-1 .29 , p = 0.43 ) .


The risk of non-spine fractures was nonsignificantly lower in the intensive than in the standard blood pressure group ( HR 0.79 , 95 % CI 0.62-1 .01 , p = 0.06 ) .


We conclude that intensive antihypertensive treatment that lowered mean systolic blood pressure to below 120 mmHg was not associated with an increased risk of falls or non-spine fractures in patients age 40 to 79 years with type 2 diabetes .


Thromboembolism is the most common complication in coiling for an unruptured aneurysm and is frequent in patients with high on-treatment platelet reactivity ( HTPR ) who are prescribed a standard antiplatelet preparation for its prevention .


To evaluate the effect of a modified antiplatelet preparation compared with a standard preparation in patients with HTPR undergoing coiling .


A prospective randomized open-label active-control trial with blinded outcome assessment at the Seoul National University Bundang Hospital from May 27 , 2013 , to April 7 , 2014 .


Patients with HTPR were randomly assigned ( 1 to 1 ) to the standard or modified preparation group .


Patients without HTPR were assigned to the non-HTPR group .


A total of 228 patients undergoing coiling for unruptured aneurysms were enrolled and allocated to the study , 126 in the HTPR group ( 63 to the standard preparation group and 63 to the modified preparation group ) and 102 to the non-HTPR group .


Intent-to-treat analysis was performed .


The modified preparation ( HTPR to aspirin , 300 mg of aspirin and 75 mg of clopidogrel bisulfate ; and HTPR to clopidogrel , 200 mg of cilostazol added to the standard regimen ) was performed before coiling in the modified preparation group .


Standard preparation ( 100 mg of aspirin and 75 mg of clopidogrel ) was maintained in the standard preparation and non-HTPR groups .


The primary outcome was a thromboembolic event defined as thromboembolism during coiling and a transient ischemic attack or ischemic stroke within 7 days after coiling .


The principal secondary outcome was a bleeding complication according to Thrombolysis in Myocardial Infarction bleeding criteria within 30 days after coil embolization .


The thromboembolic event rate was low in the modified preparation group ( 1 of 63 [ 1.6 % ] ) compared with the standard preparation group ( 7 of 63 [ 11.1 % ] ; adjusted risk difference , -11.7 % [ 95 % CI , -21.3 % to -2.0 % ] ; P = .02 ) , which had a higher thromboembolic risk than the non-HTPR group ( 1 of 102 [ 1.0 % ] ; adjusted risk difference , 8.6 % [ 95 % CI , 1.0 % to 16.3 % ] ; P = .03 ) .


All bleeding complications were of minimal grade according to Thrombolysis in Myocardial Infarction bleeding criteria .


The bleeding rate was not different between the modified ( 6 of 63 [ 9.5 % ] ) and standard ( 4 of 63 [ 6.3 % ] ) preparation groups ( adjusted risk difference , 5.6 % [ 95 % CI , -4.2 % to 15.4 % ] ; P = .26 ) .


Modified antiplatelet preparation for patients with HTPR compared with standard antiplatelet preparation reduced the thromboembolic event rate in coiling for an unruptured aneurysm without increasing bleeding .


Clinical Research Information Service Identifier : KCT0000804 .


Minority patients with breast cancer are at risk for undertreatment of cancer-related pain .


The authors evaluated the feasibility and efficacy of an automated pain intervention for improving pain and symptom management of underserved African American and Latina women with breast cancer .


Sixty low-income African American and Latina women with breast cancer and cancer-related pain were enrolled in a pilot study of an automated , telephone-based , interactive voice response ( IVR ) intervention .


Women in the intervention group were called twice weekly by the IVR system and asked to rate the intensity of their pain and other symptoms .


The patients ' oncologists received e-mail alerts if the reported symptoms were moderate to severe .


The patients also reported barriers to pain management and received education regarding any reported obstacles .


The proportion of women in both groups reporting moderate to severe pain decreased during the study , but the decrease was significantly greater for the intervention group .


The IVR intervention also was associated with improvements in other cancer-related symptoms , including sleep disturbance and drowsiness .


Although patient adherence to the IVR call schedule was good , the oncologists who were treating the patients rated the intervention as only somewhat useful for improving symptom management .


The IVR intervention reduced pain and symptom severity for underserved minority women with breast cancer .


Additional research on technological approaches to symptom management is needed .


To evaluate the effect of an improved salt-restriction spoon on the attitude of salt-restriction , the using rate of salt-restriction-spoon , the actual salt intake , and 24-hour urinary sodium excretion ( 24HUNa ) .


A community intervention study .


Two villages in Beijing .


403 local adult residents being responsible for home cooking .


Participants were randomly assigned to the intervention group or the control group .


Those in the intervention group were provided with an improved salt-restriction-spoon and health education , and were informed of their actual salt intake and 24HUNa .


Not any intervention was given to those in the control group .