In contrast , short sleepers at baseline are less likely to have resolution of insomnia diagnosis following BBTI , perhaps due to the sleep restriction component of the treatment .


Identifying the characteristics that predict positive BBTI treatment outcomes can facilitate personalized behavioral treatments to improve outcomes .


To compare the effects on health-related quality of life ( HRQoL ) of a 2-year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) based on four group-meetings to achieve compliance .


To describe different aspects of taking part in the intervention following the LFD or LCD .


Prospective , randomized trial of 61 adults with Type 2 diabetes mellitus .


The SF-36 questionnaire was used at baseline , 6 , 12 and 24 months .


Patients on LFD aimed for 55-60 energy percent ( E % ) and those on LCD for 20 E % from carbohydrates .


The patients were interviewed about their experiences of the intervention .


Mean body-mass-index was 32.7 5.4 kg/m ( 2 ) at baseline .


Weight-loss did not differ between groups and was maximal at 6 months , LFD : -3.99 4.1 kg , LCD : -4.31 3.6 kg ( p < 0.001 within groups ) .


There was an increase in the physical component score of SF-36 from 44.1 ( 10.0 ) to 46.7 ( 10.5 ) at 12 months in the LCD group ( p < 0.009 ) while no change occurred in the LFD group ( p < 0.03 between groups ) .


At 12 months the physical function , bodily pain and general health scores improved within the LCD group ( p values 0.042-0 .009 ) while there was no change within the LFD group .


Weight-changes did not differ between the diet groups while improvements in HRQoL only occurred after one year during treatment with LCD .


No changes of HRQoL occurred in the LFD group in spite of a similar reduction in body weight .


Antifibrinolytics have been used for 2 decades to reduce bleeding in cardiac surgery .


MDCO-2010 is a novel , synthetic , serine protease inhibitor .


We describe the first experience with this drug in patients .


In this phase II , double-blind , placebo-controlled study , 32 patients undergoing isolated primary coronary artery bypass grafting with cardiopulmonary bypass were randomly assigned to 1 of 5 increasing dosage groups of MDCO-2010 .


The primary aim was to evaluate pharmacokinetics ( PK ) with assessment of plasmatic concentrations of the drug , short-term safety , and tolerance of MDCO-2010 .


Secondary end points were influence on coagulation , chest tube drainage , and transfusion requirements .


PK analysis showed linear dosage-proportional correlation between MDCO-2010 infusion rate and PK parameters .


Blood loss was significantly reduced in the 3 highest dosage groups compared with control ( P = 0.002 , 0.004 and 0.011 , respectively ) .


The incidence of allogeneic blood product transfusions was lower with MDCO-2010 4/24 ( 17 % ) vs 4/8 ( 50 % ) in the control group .


MDCO-2010 exhibited dosage-dependent antifibrinolytic effects through suppression of D-dimer generation and inhibition of tissue plasminogen activator-induced lysis in ROTEM analysis as well as anticoagulant effects demonstrated by prolongation of activated clotting time and activated partial thromboplastin time .


No systematic differences in markers of end organ function were observed among treatment groups .


Three patients in the MDCO-2010 groups experienced serious adverse events .


One patient experienced intraoperative thrombosis of venous grafts considered possibly related to the study drug .


No reexploration for mediastinal bleeding was required , and there were no deaths .


This first-in-patient study demonstrated dosage-proportional PK for MDCO-2010 and reduction of chest tube drainage and transfusions in patients undergoing primary coronary artery bypass grafting .


Antifibrinolytic and anticoagulant effects were demonstrated using various markers of coagulation .


MDCO-2010 was well tolerated and showed an acceptable initial safety profile .


Larger multi-institutional studies are warranted to further investigate the safety and efficacy of this compound .


In patients with brain tumors , the choice of antiepileptic medication is guided by tolerability and pharmacokinetic interactions .


This study investigated the effectiveness of levetiracetam ( LEV ) and pregabalin ( PGB ) , 2 non-enzyme-inducing agents , in this setting .


In this pragmatic , randomized , unblinded phase II trial ( NCT00629889 ) , patients with primary brain tumors and epilepsy were titrated to a monotherapy of LEV or PGB .


Efficacy and tolerability were assessed using structured questionnaires .


The primary composite endpoint was the need to discontinue the study drug , add-on of a further antiepileptic treatment , or occurrence of at least 2 seizures with impaired consciousness during 1 year follow-up .


Over 40 months , 25 patients were randomized to LEV , and 27 to PGB .


Most were middle-aged men , with a high-grade tumor and at least one generalized convulsion .


Mean daily doses were 1125 mg ( LEV ) and 294 mg ( PGB ) .


Retention rates were 59 % in the LEV group , and 41 % in the PGB group .


The composite endpoint was reached in 9 LEV and 12 PGB patients-need to discontinue : side effects , 6 LEV , 3 PGB ; lack of efficacy , 1 and 2 ; impaired oral administration , 0 and 2 ; add-on of another agent : 1 LEV , 4 PGB ; and seizures impairing consciousness : 1 in each .


Seven LEV and 5 PGB subjects died of tumor progression .


This study shows that LEV and PGB represent valuable monotherapy options in this setting , with very good antiepileptic efficacy and an acceptable tolerability profile , and provides important data for the design of a phase III trial .


Influenza causes substantial morbidity and mortality worldwide .


Few data exist for the efficacy of neuraminidase inhibitors , which are the only readily available influenza treatment options , especially in low-income settings .


We assessed the efficacy of treatment with the neuraminidase inhibitor oseltamivir to reduce patient illness and viral shedding in people with influenza , in whom treatment was started within 5 days of symptom onset , in an urban setting in Bangladesh .


We undertook a double-blind , randomised , controlled trial between May , 2008 , and December , 2010 .


Patients with a positive rapid influenza test identified by surveillance of households in Kamalapur , Bangladesh were randomly allocated on a 1:1 basis to receive oseltamivir or placebo twice daily for 5 days .


Randomisation lists for individuals enrolled less than 48 h and 48 h or longer since illness onset were generated with permuted blocks of variable length between two and eight .


Participants and study staff were masked to treatment group .


Participants provided nasal wash specimens at enrolment and 2 , 4 , and 7 days later , and were visited daily to record symptoms .


All specimens were tested for influenza with reverse-transcriptase PCR , and if the result was positive , we isolated the virus .


The primary endpoints were duration of clinical illness and viral shedding in patients treated less than and more than 48 h since illness onset and the frequency of oseltamivir resistance during treatment .


Analyses were intention to treat unless otherwise specified .


This trial is registered with ClinicalTrials.gov , number NCT00707941 .


Overall , 1190 people with a median age of 5 years ( IQR 2-9 ) were enrolled : 794 ( 67 % ) less than 48 h since symptom onset and 396 ( 33 % ) 48 h or longer since symptom onset .


592 participants were assigned to placebo and 598 to oseltamivir .


The median duration of symptoms was shorter in the oseltamivir group ( 3 days , IQR 1-5 ) than in the placebo group ( 4 days , 1-6 ; p = 0.01 ) .


When stratified by timing of treatment initiation , in participants enrolled 48 h or longer since illness onset , the median duration of symptoms was similar in both groups ( oseltamivir 3 days [ IQR 2-5 ] , placebo 3 days [ 1-5 ] ; p = 0.04 ) .


The median duration of symptoms was reduced by 1 day in the group given oseltamivir who were enrolled less than 48 h since symptom onset compared with those given placebo , but this difference was not significant .


In those with all swab specimens ( n = 1134 ) , oseltamivir significantly reduced virus isolation on days 2 ( placebo 374 [ 66 % ] vs oseltamivir 321 [ 56 % ] ; difference 15.2 % , 95 % CI 9.5-20 .8 , p = 0.0004 ) , 4 ( 241 [ 43 % ] vs 174 [ 30 % ] ; difference 30.2 % , 95 % CI 24.6-35 .8 , p < 0.0001 ) , and 7 ( 68 [ 12 % ] vs 36 [ 6 % ] ; difference 47.5 % , 95 % CI 44.2-50 .8 , p = 0.0009 ) .


In participants enrolled 48 h or longer since illness onset , oseltamivir treatment significantly reduced virus isolation on days 2 and 4 , but not day 7 .


In participants enrolled less than 48 h since illness onset , oseltamivir treatment significantly reduced virus isolation on days 2 , 4 , and 7 .


The emergency of resistance to oseltamivir during treatment was rare overall ( < 1 % ) and in influenza A H1N1pdm09 viruses ( 3.9 % ) .


Oseltamivir treatment resulted in a modest reduction in the duration of symptoms and virus shedding in people with uncomplicated influenza infections , even when treatment was started 48 h or longer after illness onset .


Centers for Disease Control and Prevention ( in agreement with the International Centre for Diarrhoeal Disease Research , Bangladesh ) .


The severity and course of spinal pain is poorly understood in adolescents .


The study aimed to determine the prevalence and two-year incidence , as well as the course , frequency , and intensity of pain in the neck , mid back , and low back ( spinal pain ) .


This study was a school-based prospective cohort study .


All 5th and 6th grade students ( 11-13 years ) at 14 schools in the Region of Southern Denmark were invited to participate ( N = 1,348 ) .


Data were collected in 2010 and again two years later , using an e-survey completed during school time .


The lifetime prevalence of spinal pain was 86 % and 89 % at baseline and follow-up , respectively .


A group of 13.6 % ( 95 % CI : 11.8 , 15.6 ) at baseline and 19.5 % ( 95 % CI : 17.1 , 22.0 ) at follow-up reported that they had pain frequently .


The frequency of pain was strongly associated with the intensity of pain , i.e. , the majority of the participants reported their pain as relatively infrequent and of low intensity , whereas the participants with frequent pain also experienced pain of higher intensity .


The two-year incidence of spinal pain varied between 40 % and 60 % across the physical locations .


Progression of pain from one to more locations and from infrequent to more frequent was common over the two-year period .


Spinal pain is common at the age of 11-15 years , but some have more pain than others .


The pain is likely to progress , i.e. , to more locations , higher frequency , and higher pain intensity over a two-year period .


To evaluate the cardiorespiratory effects of IV administration of propofol ( 4 mg/kg ) , ketamine hydrochloride and propofol ( 2 mg/kg each ; K-P ) , or ketamine hydrochloride ( 5 mg/kg ) and diazepam ( 0.2 mg/kg ; K-D ) before and after induction of anesthesia ( IoA ) in dogs sedated with acepromazine maleate and oxymorphone hydrochloride .


10 healthy adult Beagles .


Each dog was randomly allocated to receive 2 of 3 treatments ( 1-week interval ) .


For instrumentation prior to each treatment , each dog was anesthetized with isoflurane .


After full recovery , acepromazine ( 0.02 mg/kg ) and oxymorphone ( 0.05 mg/kg ) were administered IV .


Fifteen minutes later ( before IoA ) , each dog received treatment IV with propofol , K-P , or K-D .


Cardiorespiratory and arterial blood gas variables were assessed before , immediately after , and 5 minutes after IoA .


Compared with findings before IoA , dogs receiving the K-P or K-D treatment had increased cardiac output , oxygen delivery , and heart rate 5 minutes after IoA ; K-P administration did not change mean arterial blood pressure or stroke volume and decreased systemic vascular resistance .


Propofol decreased mean arterial blood pressure and systemic vascular resistance immediately after IoA but did not change heart rate , cardiac output , or oxygen delivery .


All treatments caused some degree of apnea , hypoventilation , and hypoxemia ( Pao2 < 80 mm Hg ) .


In dogs , K-P treatment maintained mean arterial blood pressure better than propofol alone and increased heart rate , cardiac output , or oxygen delivery , as did the K-D treatment .


Supplemental 100 % oxygen should be provided during IoA with all 3 treatments .


Antibiotic resistance is the main reason for failure of Helicobacter pylori ( H. pylori ) treatment .


Currently , guidelines recommend a treatment guided by antimicrobial susceptibility testing after two failures .


However , microbial culture is not feasible everywhere , and the limited number of effective antibiotics against the bacterium narrows the options ; thus a rescue therapy combining antibiotics with a low resistance may be fitting .


Patients who have failed a first-line treatment ( either prolonged triple or sequential regimens ) and , successively , a levofloxacin-based triple therapy were considered for the study .


Subjects underwent urea breath test ( UBT ) , stool antigen test ( ST ) and endoscopy/histology to confirm the diagnosis .


Cytopenia and impaired liver and kidney function were exclusion criteria .


Fifty-four subjects were randomized 1:1 to two regimens : RMB Rabeprazole/Rifabutin/Minocycline / Bismuth sub-citrate or MTB Rabeprazole/Tinidazole/Minocycline / Bismuth sub-citrate both for 10 days .


The results were checked 6 weeks after the end of therapy with ST/UBT plus endoscopy when indicated .


RMB eradicated the bacterium in 21 patients .


Two subjects dropped out .


The eradication rate was 77.7 % ( CI 62.0-93 .4 % ) at intention-to-treat and 84.0 % ( CI 69.6-98 .4 % ) at per-protocol analysis .


MTB was successful in 14 patients ( 51.9 % , CI 33.1-70 .7 % ) .


No patient withdrew from the treatment for adverse events .


Drug-related side effects were reported only in 3 subjects , but in all cases the treatment was carried on .


The association minocycline/rifabutin seems to have a synergic effect and a good therapeutic outcome in patients who have failed at least two previous regimens , although a trial on a large population is needed .


To assess the effect of automated adjustment of the inspired oxygen fraction ( FiO2 ) on arterial oxygen saturation ( SpO2 ) and cerebral tissue oxygen saturation ( SctO2 ) in very low birth weight infants with frequent fluctuations in oxygenation .


Fifteen infants ( median gestational age , 25 weeks [ range , 23-28 weeks ] ; median age , 34 days [ range , 19-74 days ] ) were assigned in random sequence to 24 hours of automated adjustment of FiO2 or manual adjustment of FiO2 .


Primary outcome measurements were time within the SpO2 target range and the area under the curve above and below a defined SctO2 range .


Percentage of time within the SpO2 target range increased during automated FiO2 control ( 76.3 % 9.2 % vs 69.1 % 8.2 % for manual ; P < .01 ) .


Prolonged episodes with SpO2 < 88 % of > 60 seconds duration ( median , 115 episodes [ range , 67-240 ] vs 54 episodes [ range , 7-184 ] ; P < .01 ) and of > 180 seconds duration ( median , 13 episodes [ range , 6-39 ] vs 2 episodes [ range , 0-5 ] ; P < .01 ) decreased significantly during the automated period .


Percentage of time with SpO2 > 96 % decreased during automated control ( 6.6 % 4.4 % vs 10.4 % 3.3 % ; P < .02 ) .


There was no significant difference in FiO2 exposure .


The area ( deviation time ) below and above the defined SctO2 threshold did not differ between the 2 periods ( median , 59.7 % * seconds [ range , 17.2 % -208.3 % ] for manual vs 49.0 % * seconds [ range , 4.3 % -193.7 % ] for automated ; P = .36 ) .


Automated FiO2 control in preterm infants with frequent SpO2 fluctuations significantly increased the time within the SpO2 target range and reduced the incidence of prolonged hypoxemic events compared with manual FiO2 adjustment , but did not significantly affect cerebral tissue oxygenation .


In patients with severe sepsis , no randomized clinical trial has tested the concept of de-escalation of empirical antimicrobial therapy .


This study aimed to compare the de-escalation strategy with the continuation of an appropriate empirical treatment in those patients .


This was a multicenter non-blinded randomized noninferiority trial of patients with severe sepsis who were randomly assigned to de-escalation or continuation of empirical antimicrobial treatment .


Recruitment began in February 2012 and ended in April 2013 in nine intensive care units ( ICUs ) in France .


Patients with severe sepsis were assigned to de-escalation ( n = 59 ) or continuation of empirical antimicrobial treatment ( n = 57 ) .


The primary outcome was to measure the duration of ICU stay .


We defined a noninferiority margin of 2 days .


If the lower boundary of the 95 % confidence interval ( CI ) for the difference in patients assigned to the de-escalation group was less than 2 days , as compared with that of patients assigned to the continuation group , de-escalation was considered to be noninferior to the continuation strategy .


Secondary outcomes included mortality at 90 days , occurrence of organ failure , number of superinfections , and number of days with antibiotics during the ICU stay .


The median duration of ICU stay was 9 [ interquartile range ( IQR ) 5-22 ] days in the de-escalation group and 8 [ IQR 4-15 ] days in the continuation group , respectively ( P = 0.71 ) .


The mean difference was 3.4 ( 95 % CI -1.7 to 8.5 ) .


A superinfection occurred in 16 ( 27 % ) patients in the de-escalation group and six ( 11 % ) patients in the continuation group ( P = 0.03 ) .


The numbers of antibiotic days were 9 [ 7-15 ] and 7.5 [ 6-13 ] in the de-escalation group and continuation group , respectively ( P = 0.03 ) .


Mortality was similar in both groups .


As compared to the continuation of the empirical antimicrobial treatment , a strategy based on de-escalation of antibiotics resulted in prolonged duration of ICU stay .


However , it did not affect the mortality rate .


To evaluate the effect of a hamstring block for postoperative pain management using 20 mL of 0.25 % bupivacaine compared with placebo after anterior cruciate ligament ( ACL ) reconstruction with a hamstring autograft .


In a 3-month period , 45 patients undergoing ACL reconstruction with a hamstring autograft who all received a femoral nerve block were randomized to receive either 20 mL of 0.25 % bupivacaine or 20 mL of saline water administered through a catheter into the donor-site space .


The patients and recovery staff were blinded to the treatment .


Postoperative donor-site pain was evaluated subjectively by the patients using a pain score ( Likert scale from 0 to 10 ) .


The pain was registered for each hour in the first 6 hours and thereafter once daily for 8 days .


Furthermore , the requirement for postoperative analgesic medicine was registered .


The hamstring block group ( n = 23 ) had significantly less pain for each of the first 6 postoperative hours .


The pain score was reduced from 4.2 to 2.3 ( 95 % confidence interval , 1.3 to 3.3 ) ( P = .01 ) in the first hour and from 2.8 to 1.3 ( 95 % confidence interval , 0.6 to 1.9 ) in the sixth hour , and there was a significantly lower overall requirement for early postoperative fentanyl , reduced from a mean of 58 to 35 g ( P = .02 ) , and morphine , reduced from a mean of 10 to 6 mg ( P = .04 ) .


After 6 hours , there was no difference in the pain level and use of analgesics between the 2 groups .


With the use of a donor-site block in hamstring ACL reconstruction , the donor-site pain level , as well as the overall requirement for fentanyl and morphine , was significantly reduced in the first 6 postoperative hours .


No effect of the donor-site block was seen after 6 hours .


Level I , therapeutic , randomized controlled study .


The aim of this study was to evaluate the effect of a low tube voltage technique and hybrid iterative reconstruction ( HIR ) on image quality at 3-dimensional computed tomographic angiography ( 3D-CTA ) of the liver .


Before hepatic surgery , we randomly assigned 60 patients ( 17 women , 43 men ; mean SD age , 68.9 10.1 years ) who had undergone 3D-CTA to 1 of 2 protocols ; 30 patients underwent scanning under the conventional 120-kilovolt ( peak ) protocol with filtered back projection ( P1 ) ; and 30 patients , under an 80-kilovolt ( peak ) protocol with HIR ( P2 ) .


The estimated effective radiation dose , computed tomographic attenuation , image noise , contrast-to-noise ratio , and figure of merit were calculated , and the visual image quality of 3D-CTA was scored on a 4-point scale .


The mean effective radiation dose was significantly lower under P2 than P1 ( 4.8 1.2 vs 7.2 1.5 mSv , P < 0.01 ) .


P1 and P2 did not significantly differ with respect to the image noise ( 10.5 2.3 vs 9.9 1.6 Hounsfield units ; P = 0.46 ) .


Computed tomographic attenuation , contrast-to-noise ratio , figure of merit , and the visual scores for image quality were higher under P2 than P1 ( P < 0.01 ) .


The use of low tube voltage and HIR can yield significantly improved image quality at 3D-CTA of the liver .


To improve arterial catheter ( AC ) securement and reduce AC failure ; to assess feasibility of a large randomised controlled trial .


A four-arm , parallel , randomised , controlled , non-blinded pilot trial with 195 intensive care patients taking part , in a tertiary referral hospital in Brisbane , Australia from May to November 2012 .


Standard polyurethane ( SPU ) dressing ( controls ) ; bordered polyurethane ( BPU ) + SPU dressing ; tissue adhesive ( TA ) + SPU dressing ; and sutureless securement device ( SSD ) + SPU dressing ( no sutures used ) .


AC failure , ie , complete dislodgement , occlusion ( monitor failure , inability to infuse or fluid leaking ) , pain or infection ( local or blood ) .


Median AC dwell time was 26.2 hours and was comparable between groups .


AC failure occurred in 26/195 patients ( 13 % ) .


AC failure was significantly worse with SPU dressings ( 10/47 [ 21 % ] ) than with BPU + SPU dressings ( 2 / 43 [ 5 % ] ; P = 0.03 ) , but not significantly different to TA + SPU ( 6/56 [ 11 % ] ; P = 0.18 ) or SSD + SPU ( 8/49 [ 16 % ] ; P = 0.61 ) .


The dressing applied at AC insertion lasted until AC removal in 68 % of controls ; 56 % of BPU + SPU dressings ; 73 % of TA + SPU dressings ; and 80 % of SSD + SPU dressings ( all P > 0.05 ) .


There were no infections or serious adverse events .


Patient and staff satisfaction with all products was high .


Median costs ( labour and materials ) for securement per patient were significantly higher in all groups compared with the control group ( SPU , $ 3.48 [ IQR , $ 3.48 - $ 9.79 ] ; BPU + SPU , $ 5.07 [ IQR , $ 5.07 - $ 12.99 ] ; SSD + SPU , $ 10.90 [ IQR , $ 10.90 - $ 10.90 ] ; TA + SPU , $ 17.70 [ IQR , $ 17.70 - $ 38.36 ] ; all P < 0.01 ) .


AC failure occurred significantly less often with BPU + SPU dressings than with SPU dressings .


TA + SPU and SSD + SPU dressings should be further investigated and compared with BPU + SPU dressings as controls .


The novel approach of TA + SPU dressings appeared safe and feasible .


To evaluate the veterinary student learning outcome of 2 methods of equine rectal examination training .


Randomized prospective study .


Veterinary students ( 3rd and 4th year ; n = 40 ) and practicing equine veterinarians ( n = 10 ) .


Year 1 : Group 1 ( n = 11 ) and Group 2 students ( n = 10 ) received skilled instructor ( SI ) and laparoscopic-guidance ( LG ) , respectively , during rectal exam instruction .


All students were tested on rectal identification of 4 abdominal organs .


Year 2 : One group of students ( n = 19 ) was trained and subsequently tested using each technique , first SI , followed by LG .


Subjective evaluation of laparoscopy as a teaching tool was achieved with veterinary students and equine practitioners .


A significantly greater percentage of students having LG compared to SI were able to correctly identify the left kidney ( Year 1 ) and the spleen , cecum , and right ovary ( Year 2 ) .


A significantly greater proportion of LG trained students in years 1 and 2 ( 100 % and 95 % , respectively ) were also able to identify 75 % of organs compared with SI ( 27 % and 21 % , respectively ) .


Both students and veterinarians uniformly provided favorable feedback for LG in teaching rectal palpation skills .


The LG method of equine rectal examination instruction resulted in improved learning for identification of several key abdominal organs compared with SI .


We report our experience with a modified mini-maze procedure and pulmonary vein isolation using radiofrequency energy for treating persistent atrial fibrillation during coronary artery bypass grafting ( CABG ) .


Ninety-five patients with persistent atrial fibrillation and coronary heart disease underwent open heart surgery combined with intraoperative irrigated radiofrequency ablation .


Patients were randomized into the following three groups : CABG and irrigated radiofrequency pulmonary vein isolation ( CABG+PVI , n = 31 ) ; CABG and an irrigated radiofrequency modified mini-maze procedure ( CABG+MM , n = 30 ) ; and isolated CABG ( CABG alone , n = 34 ) .


All patients received implantable loop recorders .


No reoperation and no hospital mortality were recorded .


Mean follow-up was 14.4 9.7 months .


The implantable loop recorder-determined freedom from atrial fibrillation was 80 % in the CABG+PVI group , 86.2 % in the CABG+MM group and 44.1 % in the CABG alone group .


Patients with concomitant atrial fibrillation and coronary heart disease may benefit from intraoperative ablation to prevent relapse of arrhythmia .


Dystrophinopathy is a rare , severe muscle disorder , and nonsense mutations are found in 13 % of cases .


Ataluren was developed to enable ribosomal readthrough of premature stop codons in nonsense mutation ( nm ) genetic disorders .


Randomized , double-blind , placebo-controlled study ; males 5 years with nm-dystrophinopathy received study drug orally 3 times daily , ataluren 10 , 10 , 20 mg/kg ( N = 57 ) ; ataluren 20 , 20 , 40 mg/kg ( N = 60 ) ; or placebo ( N = 57 ) for 48 weeks .


The primary endpoint was change in 6-Minute Walk Distance ( 6MWD ) at Week 48 .


Ataluren was generally well tolerated .


The primary endpoint favored ataluren 10 , 10 , 20 mg/kg versus placebo ; the week 48 6MWD = 31.3 meters , post hoc P = 0.056 .


Secondary endpoints ( timed function tests ) showed meaningful differences between ataluren 10 , 10 , 20 mg/kg , and placebo .


As the first investigational new drug targeting the underlying cause of nm-dystrophinopathy , ataluren offers promise as a treatment for this orphan genetic disorder with high unmet medical need .


Increased coagulation activation may contribute to the high incidence of cardiovascular complications observed in obese and type 2 diabetes ( T2D ) subjects .


Although tissue factor ( TF ) , the primary initiator of coagulation is increased in obesity , its expression in adipose tissues and its association with metabolic parameters are unclear .


We sought to compare TF expression in plasma and adipose tissues of obese subjects with and without T2D , its correlation with metabolic parameters , and regulation in response to antidiabetic drugs .


Subjects were recruited from diabetes clinics and adipose tissue was obtained by needle biopsy of lower subcutaneous abdominal depot .


For the intervention study , subjects were randomized into treatment groups with rosiglitazone or metformin for 4 months .


Plasma TF antigen , activity , and adipose TF mRNA were greater in obese T2D subjects compared with obese nondiabetics .


Plasma TF activity correlated with fasting insulin , glucose , and free fatty acids , ( FFAs ) , and adipose TF mRNA correlated with plasma FFA .


Plasma TF activity was reduced by metformin and increased with rosiglitazone treatment .


Specific diabetes-related metabolic parameters , but not obesity per se , are correlated with TF expression .


Regulation of TF activity by different classes of antidiabetic drugs may relate to protective or adverse cardiovascular outcomes .


To observe the effects of Liuwei Dihuang Granule ( [ symbols ; see text ] , LDG ) for tonifying Kidney ( Shen ) on the outcomes of in vitro fertilization pre-embryo transfer ( IVF-ET ) of infertility women with Kidney-yin deficiency syndrome and to explore its mechanism by detecting the proteome expression in the follicular fluid .


Sixty-six infertility patients of Kidney-yin deficiency syndrome who would undergo IVF-ET , were randomly assigned to a treatment group and a control group according to a random number table , 33 cases in each group .


Another 33 cases of non-Kidney-yin deficiency syndrome was taken as a syndrome-control group .


Besides Western routine therapy , LDG was given 3 menstrual cycles before IVF to the treatment group , and a placebo granule to the control and syndrome-control groups .


The scores of Kidney-yin deficiency symptoms ( sore waist and knees , dry vagina , dysphoria with feverish sensation in the chest , palms and soles , etc. ) were assessed , the number of retrieved oocytes , rates of high quality oocytes and embryos , fertility rate and clinical pregnancy rate were recorded , and the follicular fluid was collected on the day when the ovum was picked up , the differential protein expression was detected using two-dimensional gel electrophoresis , and then , matrix assisted laser desorption ionization time-of flight mass spectrometry ( MALDI-TOF-MS ) was applied to identify the proteins .


The syndrome score in the treatment group decreased significantly from 16.092.58 to 8.672.13 , while it changed insignificantly in the control group , with a significant difference in the lowering score between the two groups ( P < 0.05 ) ; the high quality rates of oocytes and embryos and clinical pregnancy rate were all superior in the treatment group to the control group ( 82.29 % vs 78.08 % , 76.76 % vs 68.79 % , 63.64 % vs 36.36 % , all P < 0.05 ) .


The protein expression map from the follicular fluid showed that compared with the control group , 33 differential protein expressions were found in the syndrome-control group , among which 18 were down-regulated , and 15 up-regulated ; in the treatment group 28 differential protein expressions were found , among which 15 were down-regulated , and 13 up-regulated .


Through MALDI-TOF-MS , 14 proteins were identified ( P < 0.05 ) .


For the infertility patients undergoing IVF , LDG could alleviate clinical symptoms , improve rates of high quality oocytes and embryos , so as to raise clinical pregnancy rate .


The mechanism may be through regulating proteome expression in the follicular fluid to improve the developmental microenvironment for oocytes which would lead to a successful embryo implantation .


We evaluated the impact of influenza vaccine text message reminders in a low-income obstetric population .


We conducted a randomized controlled trial that enrolled 1187 obstetric patients from 5 community-based clinics in New York City .


The intervention group received 5 weekly text messages regarding influenza vaccination starting mid-September 2011 and 2 text message appointment reminders .


Both groups received standard automated telephone appointment reminders .


The prespecified endpoints were receipt of either pre - or postpartum influenza vaccination calculated cumulatively at the end of each month ( September-December 2011 ) .


After adjusting for gestational age and number of clinic visits , women who received the intervention were 30 % more likely to be vaccinated as of December 2011 ( adjusted odds ratio [ AOR ] = 1.30 ; 95 % confidence interval [ CI ] = 1.003 , 1.69 end of September : AOR = 1.34 ; 95 % CI = 0.98 , 1.85 ; October : AOR = 1.35 ; 95 % CI = 1.05 , 1.75 ; November : AOR = 1.27 ; 95 % CI = 0.98 , 1.65 ) .


The subgroup of women early in the third trimester at randomization showed the greatest intervention effect ( December 31 : 61.9 % intervention vs 49.0 % control ; AOR = 1.88 ; 95 % CI = 1.12 , 3.15 ) .


In this low-income obstetric population , text messaging was associated with increased influenza vaccination , especially in those who received messages early in their third trimester .


Despite the large number of Latinos living in the United States , little research has evaluated the effectiveness of different vocational rehabilitation programs for individuals with severe mental illness in this rapidly growing minority population .


This article presents a secondary analysis of a randomized , controlled trial comparing supported employment with 2 other vocational rehabilitation programs in 3 ethnic/racial groups of participants with severe mental illness : Latinos , non-Latino African Americans , and non-Latino Whites .


The data were drawn from a previously published randomized , controlled trial comparing supported employment with standard vocational rehabilitation services and a psychosocial clubhouse program in persons with severe mental illness ( Mueser et al. , 2004 ) , including 64 Latinos , 91 non-Latino African Americans , and 43 non-Latino Whites .


Comparisons were made between the 3 groups at baseline on demographic characteristics , clinical and psychosocial functioning , and quality of life .


Within each ethnic/racial group , competitive employment and all paid employment outcomes were compared between the 3 vocational rehabilitation programs over the 2-year study period .


At baseline , the Latino participants had lower levels of education and disability income , were less likely to have worked competitively over the previous 5 years , had more severe symptoms , and worse psychosocial functioning than the non-Latino African American or non-Latino White participants .


Latinos randomized to supported employment had better competitive and all-paid work outcomes than those assigned to either standard services or the psychosocial clubhouse program , similar to the non-Latino consumers .


Rates of competitive work for consumers in supported employment were comparable across all 3 racial/ethnic groups .


Supported employment is effective at improving competitive work in Latinos with severe mental illness .


Efforts should be made to increase access to supported employment in the growing population of Latinos with severe mental illness .


A new , novel product , Cynatine HNS , was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized , double-blind , placebo-controlled clinical trial .


A total of 50 females were included and randomized into two groups .


The active group ( n = 25 ) received 2 capsules containing Cynatine HNS , comprised of Cynatine brand keratin ( 500 mg ) plus vitamins and minerals , per day , and the placebo group ( n = 25 ) received 2 identical capsules of maltodextrin per day for 90 days .


End points for hair loss , hair growth , hair strength , amino acid composition , and hair luster were measured .


End points were also measured for nail strength and the appearance of nails .


The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo .


Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less .


EudraCT number is 2014-002645-22 .


Individuals with schizophrenia have functionally significant deficits in automatic and controlled social cognition , but no currently available pharmacologic treatments reduce these deficits .


The neuropeptide oxytocin has multiple prosocial effects when administered intranasally in humans and there is growing interest in its therapeutic potential in schizophrenia .


We administered 40 IU of oxytocin and saline placebo intranasally to 29 male subjects with schizophrenia and 31 age-matched , healthy controls in a randomized , double-blind , placebo-controlled , cross-over study .


Social cognition was assessed with The Awareness of Social Inference Test ( TASIT ) and the Reading the Mind in the Eyes Test ( RMET ) .


We examined the effects of oxytocin administration on automatic social cognition ( the ability to rapidly interpret and understand emotional cues from the voice , face , and body ) ; controlled social cognition ( the ability to comprehend indirectly expressed emotions , thoughts , and intentions through complex deliberations over longer time periods ) ; and a control task ( the ability to comprehend truthful dialog and perform general task procedures ) in individuals with and without schizophrenia using mixed factorial analysis of variance models .


Patients with schizophrenia showed significant impairments in automatic and controlled social cognition compared to healthy controls , and administration of oxytocin significantly improved their controlled , but not automatic , social cognition , F ( 1 , 58 ) = 8.75 ; p = 0.004 .


Conversely , oxytocin administration had limited effects on social cognition in healthy participants .


Patients and controls performed equally well and there were no effects of oxytocin administration on the control task .


Intact social cognitive abilities are associated with better functional outcomes in individuals with schizophrenia .


Our data highlight the potentially complex effects of oxytocin on some but not all aspects of social cognition , and support the exploration of intranasal oxytocin as a potential adjunct treatment to improve controlled social cognition in schizophrenia .


To investigate associations between timing of adiposity rebound ( AR ; the period in childhood where BMI begins to increase from its nadir ) and adiposity ( BMI , fat mass ) at age 15 years in the Avon Longitudinal Study of Parents and Children ( ALSPAC ) .


The sample consisted of 546 children with AR derived in childhood and BMI and fat mass index ( FMI ; fat mass measured by dual-energy radiograph absorptiometry/height in m ( 2 ) ) measured at 15 years .


Multivariable linear regression models were based on standardized residuals of log BMI and log FMI to allow comparison of regression coefficients across outcomes .


There were strong dose-response associations between timing of AR and both adiposity outcomes at 15 years independent of confounders .


BMI was markedly higher in adolescence for those with very early AR ( by 3.5 years ; = 0.70 ; 95 % confidence interval [ CI ] : 0.33-1 .07 ; P .001 ) and was also higher for those with early AR ( between 3.5 and 5 years ; = 0.34 ; 95 % CI : 0.08-0 .59 ; P = .009 ) compared with those with later AR ( > 5 years ) after full adjustment for a range of potential confounders .


Similar magnitudes of association were found for FMI after full adjustment for confounders ( compared with later AR : very early AR = 0.74 ; 95 % CI : 0.34-1 .15 ; P .001 ; early AR = 0.35 ; 95 % CI : 0.07-0 .63 ; P = .02 ) .


Early AR is strongly associated with increased BMI and FMI in adolescence .


Preventive interventions should consider targeting modifiable factors in early childhood to delay timing of AR .


Randomized clinical trial .


To compare the effects of functional stabilization training ( FST ) versus standard training on knee pain and function , lower-limb and trunk kinematics , trunk muscle endurance , and eccentric hip and knee muscle strength in women with patellofemoral pain .


A combination of hip - and knee-strengthening exercise may be more beneficial than quadriceps strengthening alone to improve pain and function in individuals with patellofemoral pain .


However , there is limited evidence of the effectiveness of these exercise programs on the biomechanics of the lower extremity .


Thirty-one women were randomized to either the FST group or standard-training group .


Patients attended a baseline assessment session , followed by an 8-week intervention , and were reassessed at the end of the intervention and at 3 months after the intervention .


Assessment measures were a 10-cm visual analog scale for pain , the Lower Extremity Functional Scale , and the single-leg triple-hop test .


A global rating of change scale was used to measure perceived improvement .


Kinematics were assessed during the single-leg squat .


Outcome measures also included trunk endurance and eccentric hip and knee muscle strength assessment .


The patients in the FST group had less pain at the 3-month follow-up and greater global improvement and physical function at the end of the intervention compared to those in the standard-training group .


Lesser ipsilateral trunk inclination , pelvis contralateral depression , hip adduction , and knee abduction , along with greater pelvis anteversion and hip flexion movement excursions during the single-leg squat , were only observed in the FST group after the intervention .


Only those in the FST group had greater eccentric hip abductor and knee flexor strength , as well as greater endurance of the anterior , posterior , and lateral trunk muscles , after training .


An intervention program consisting of hip muscle strengthening and lower-limb and trunk movement control exercises was more beneficial in improving pain , physical function , kinematics , and muscle strength compared to a program of quadriceps-strengthening exercises alone .


To evaluate the 4-year results following a randomised controlled trial ( RCT ) comparing open ( ONF ) and laparoscopic ( LNF ) Nissen fundoplication in children .


It is assumed that long-term results of ONF and LNF are comparable .


No randomised studies have been performed in children .


A follow-up study was performed in children randomised to ONF or LNF ( clinicaltrials.gov identifier NCT00259961 ) .


Recurrent gastro-oesophageal reflux ( GER ) was documented by upper gastrointestinal contrast study and/or 24-h pH study .


Nutritional status , retching and other symptoms were investigated .


A questionnaire was used to assess the quality of life before and after surgery .


Thirty-nine children were randomised to ONF ( n = 20 ) or LNF ( n = 19 ) .


There were 15 ONF and 16 LNF neurologically impaired children .


One patient ( ONF group ) was lost to follow-up .


Follow-up was 4.1 years ( 3.1-5 .3 ) for ONF group and 4.1 years ( 2.6-5 .1 ) for LNF group ( p = 0.9 ) .


Seven neurologically impaired children had died by the time of follow-up ( 3 ONF , 4 LNF ) .


Incidence of recurrent GER was 12.5 % in the ONF and 20 % in the LNF ( p = ns ) .


One patient in each group underwent redo-Nissen fundoplication .


Nutritional status improved in both groups , as indicated by a significant increase in weight Z-score ( p < 0.01 ) .


Gas bloat and dumping syndrome were present in both groups ( p = ns ) .


Incidence of retching was lower in the laparoscopic group ( p = 0.01 ) .


Quality of life improved in both groups ( p = ns ) .


Open and laparoscopic Nissen provide similar control of reflux and quality of life at follow-up .


LNF is associated with reduced incidence of retching persisting at 4-year follow-up .


NCT00259961 .


To determine the efficacy of consolidation chemotherapy ( CC ) with docetaxel and cisplatin ( DP ) after concurrent chemoradiotherapy ( CCRT ) with the same agents in locally advanced non-small-cell lung cancer ( LA-NSCLC ) .


Patients were randomly assigned to either CCRT alone ( observation arm ) or CCRT followed by CC ( consolidation arm ) .


CCRT with docetaxel ( 20 mg/m ( 2 ) ) and cisplatin ( 20 mg/m ( 2 ) ) was administered every week for 6 weeks with a total dose of 66 Gy of thoracic radiotherapy in 33 fractions .


In the consolidation arm , patients were further treated with three cycles of DP ( 35 mg/m ( 2 ) each on days 1 and 8 , every 3 weeks ) .


The primary end point was 40 % improvement in progression-free survival ( PFS ) compared with observation .


From October 2005 to April 2011 , 437 patients were randomly assigned .


Seventeen patients did not start CCRT as a result of consent withdrawal or ineligibility reasons after random assignment , leaving 420 patients for this analysis ( n = 211 for observation ; n = 209 for consolidation ) .


Patient characteristics were similar in both arms .


In the consolidation arm , 143 patients ( 68 % ) received CC , of whom 88 ( 62 % ) completed three planned cycles .


The median PFS was 8.1 months in the observation arm and 9.1 months in the consolidation arm ( hazard ratio , 0.91 ; 95 % CI , 0.73 to 1.12 ; P = .36 ) .


Median overall survival times were 20.6 and 21.8 months in the observation and consolidation arms , respectively ( HR , 0.91 ; 95 % CI , 0.72 to 1.25 ; P = .44 ) .


CC with DP after CCRT with weekly DP in LA-NSCLC failed to further prolong PFS .


CCRT alone should remain the standard of care .


In mainland China , peginterferon ( PEG-IFN ) alfa-2b 1.0 g/kg/wk for 24 weeks is the approved treatment for HBeAg-positive chronic hepatitis B.


This multicenter , randomized trial evaluated the safety and efficacy of regimens utilizing increased dose or treatment duration in treatment-naive Chinese patients with chronic hepatitis B.


670 HBeAg-positive patients from China , Malaysia , Taiwan area , Singapore , and Thailand were enrolled .


Patients received PEG-IFN alfa-2b 1.0 g/kg/wk ( arm A ) or 1.5 g/kg/wk ( arm B ) for 24 weeks , or 1.5 g/kg/wk for 48 weeks ( arm C ) .


The primary end point was loss of HBeAg 24 weeks after end of treatment .


At the end of follow-up , HBeAg loss was significantly greater in arm C compared with arm A ( 31.3 % vs. 17.3 % ; P = 0.001 ) and arm B ( 31.3 % vs. 18.1 % ; P = 0.001 ) .


No significant difference in the rate of HBeAg loss was observed between arms A and B.


The proportions of patients with HBe seroconversion , HBV DNA levels < 20,000 IU/mL , and ALT normalization at the end of follow-up were significantly higher in arm C compared with arm A and arm B.


In arms A , B , and C , rates of early treatment discontinuation were 6.3 % , 4.9 % , and 8.9 % ; of discontinuation due to an AE , 2 % , 3 % , and 3 % ; and of AEs requiring dose modification , 3 % , 6 % , and 10 % , respectively .


In Chinese patients with HBeAg-positive chronic hepatitis B , PEG-IFN alfa-2b 1.5 g/kg/wk for 48 weeks is more efficacious compared with 1.0 and 1.5 g/kg/wk for 24 weeks .


To evaluate the impact of contact lens ( CL ) - induced corneal swelling on the optical quality of the eye by means of the double-pass technique .


Measurements of 6 healthy subjects were obtained in 5 visits over 1 week , at baseline and after sleeping with 4 different CLs of +0.50 D , +2.00 D , +5.00 D and +8.00 D ( Acuvue2 ) , randomly fitted on 4 different days .


The control eye wore no CL .


Corneal pachymetry and optical quality of the eye ( OQAS , Visiometrics ) were measured once at baseline and at three interval times in the follow-up visits : immediately after CL removal , and 1 and 2 h after CL removal .


Optical quality was evaluated by means of the Strehl ratio and OQAS values at 100 % , 20 % and 9 % contrasts .


Intraocular scattering was evaluated with the objective scatter index ( OSI ) .


Mean overnight swelling was 5.98 4.29 % in CL-eyes versus 0.30 0.78 % in control eyes ( p < 0.01 ) .


Corneal swelling was maximal immediately after CL removal and decreased with time ( p < 0.01 ) .


A significant worsening in all optical quality parameters and a significant increase of the OSI were found in eyes with corneal swelling ( p < 0.05 ) .


Two hours after CL removal there were no statistically significant differences ( p > 0.05 ) between CL-eyes and control eyes in any of the measured parameters .


Corneal swelling has a significant impact on the optical quality of the eye and on intraocular scattering as assessed with the double-pass technique .


Everolimus and cyclosporine A ( CsA ) exhibit synergistic immunosuppressive activity when used in combination .


We examined the safety and efficacy of the use of everolimus with a cyclosporine-sparing strategy in de novo renal transplant recipients .


A comparative , parallel , randomized , open-label 1-year study has been performed in 148 patients from five transplant centers to compare the efficacy and tolerability of everolimus and reduced exposure CsA ( the investigational group ) or enteric-coated mycophenolate sodium and standard-exposure CsA ( the control group ) in combination with basiliximab and steroids .


The eligible subjects were randomly assigned at 1 month after transplantation .


Efficacy failure ( biopsy-proven acute rejection , death , graft loss , or loss to follow-up ) , safety , and renal function were evaluated .


One graft loss has been reported in the control group and no patient death were reported in either group .


The incidence of biopsy-proven acute rejection until 12 months after transplantation of the investigational group was 7.5 % , compared to 11.1 % of the control group ( P = 0.565 ) .


The mean estimated glomerular filtration rates of the investigational group at 12 months after transplantation was significantly higher ( 68.1 16.8 ml/min/1 .73 m ( 2 ) ) than that of the control group ( 60.6 15.8 ml/min/1 .73 m ( 2 ) ; P = 0.016 ) .


There was no significant difference ( P > 0.05 ) in the incidence of discontinuations and serious adverse events between the groups .


The results of this study provide the evidences that ( 1 ) the calcineurin inhibitor ( CNI ) minimization by the introduction of everolimus after 1-month posttransplantation keeps the incidences of acute rejection and additional risks as low as the conventional immunosuppression ; ( 2 ) it allows minimizing CNI exposure , consequently reducing CNI nephrotoxicity and preserving renal function .


The purpose of this randomized controlled study was to examine and compare the immediate and retention effects of speed-dependent treadmill training ( SDTT ) and rhythmic auditory-cued ( RAC ) overground walking on gait function and fall risk in individuals with Parkinson 's disease ( PD ) .


Twenty participants ( mean age 66.1 yrs ) with idiopathic PD were randomized into either SDTT ( n = 10 ) or RAC ( n = 10 ) progressive , interval-based locomotor training protocols .


Immediate and retention training effects on gait function and fall risk were measured by comfortable and fast gait speed ( CGS , FGS ) , 6-Minute Walk Test ( 6MWT ) , and Functional Gait Assessment ( FGA ) .


Immediate within-group training effects revealed significant gains in CGS , 6MWT , and FGA for the RAC group , and in FGS , 6-MinuteWalk Test , and FGA for the SDTT group .


Retention effects were found at 3-month follow-up for all gait measures in the RAC group , and for FGS and FGA in the SDTT group .


No statistically significant differences in immediate or retention training effects on gait measures were found between groups .


Externally-cued locomotor training with progressive and interval-based speed challenges , either with RAC overground or on a treadmill , produced significant improvements in walking speed , endurance , and dynamic balance during walking .


High-sensitivity troponin-I ( hs-TnI ) measurement improves risk assessment for cardiovascular events in many clinical settings , but the added value in atrial fibrillation patients has not been described .


At randomization , hs-TnI was analyzed in 14 821 atrial fibrillation patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial comparing apixaban with warfarin .


The associations between hs-TnI concentrations and clinical outcomes were evaluated by using adjusted Cox analysis .


The hs-TnI assay detected troponin ( 1.3 ng/L ) in 98.5 % patients , 50 % had levels > 5.4 , 25 % had levels > 10.1 , and 9.2 % had levels 23 ng/L ( the 99th percentile in healthy individuals ) .


During a median of 1.9 years follow-up , annual rates of stroke or systemic embolism ranged from 0.76 % in the lowest hs-TnI quartile to 2.26 % in the highest quartile ( > 10.1 ng/L ) .


In multivariable analysis , hs-TnI was significantly associated with stroke or systemic embolism , adjusted hazard ratio 1.98 ( 1.42-2 .78 ) , P = 0.0007 .


hs-TnI was also significantly associated with cardiac death ; annual rates ranged from 0.40 % to 4.24 % , hazard ratio 4.52 ( 3.05-6 .70 ) , P < 0.0001 , in the corresponding groups , and for major bleeding hazard ratio 1.44 ( 1.11-1 .86 ) , P = 0.0250 .


Adding hs-TnI levels to the CHA2DS2VASc score improved c-statistics from 0.629 to 0.653 for stroke or systemic embolism , and from 0.591 to 0.731 for cardiac death .


There were no significant interactions with study treatment .


Troponin-I is detected in 98.5 % and elevated in 9.2 % of atrial fibrillation patients .


The hs-TnI level is independently associated with a raised risk of stroke , cardiac death , and major bleeding and improves risk stratification beyond the CHA2DS2VASc score .


The benefits of apixaban in comparison with warfarin are consistent regardless of hs-TnI levels .


http://www.clinicaltrials.gov .


Unique identifier : NCT00412984 .


Heavy drinking among individuals with HIV is associated with major health concerns ( liver disease , medication nonadherence , immune functioning ) , but little is known about cognitive-motivational factors involved in alcohol consumption in this population , particularly reasons for limiting drinking .


Urban HIV primary care patients ( N = 254 ; 78.0 % male ; 94.5 % African American or Hispanic ) in a randomized trial of brief drinking-reduction interventions reported on reasons for limiting drinking , alcohol consumption , and alcohol dependence symptoms prior to intervention .


Exploratory factor analysis indicated 3 main domains of reasons for limiting drinking : social reasons ( e.g. , responsibility to family ) , lifestyle reasons ( e.g. , religious/moral reasons ) , and impairment concerns ( e.g. , hangovers ) .


These factors evidenced good internal consistency ( s = 0.76 to 0.86 ) .


Higher scores on social reasons for limiting drinking were associated with lower typical quantity , maximum quantity , and binge frequency ( ps < 0.01 ) , and higher scores on lifestyle reasons were associated with lower maximum quantity , binge frequency , and intoxication frequency ( ps < 0.01 ) .


In contrast , higher scores on impairment concerns were associated with more frequent drinking and intoxication , and higher risk of alcohol dependence ( ps < 0.05 ) , likely because dependent drinkers are more familiar with alcohol-induced impairment .


The current study is the first to explore reasons for limiting drinking among individuals with HIV and how these reasons relate to alcohol involvement .


This study yields a scale that can be used to assess reasons for limiting drinking among HIV-positive drinkers and provides information that can be used to enhance interventions with this population .


Discussing social and lifestyle reasons for limiting drinking among less extreme drinkers may support and validate these patients ' efforts to limit engagement in heavy drinking ; discussion of impairment reasons for limiting drinking may be a way to engage dependent drinkers in efforts to decrease their alcohol consumption .


Advanced type 2 diabetes mellitus ( T2DM ) needing insulin therapy is common .


Most conventional anti-hyperglycemic drugs have limited efficacies and significant side effects , so that better anti-hyperglycemic agents are needed .


Urtica dioica L. ( nettle ) leaves have insulin secretagogue , PPARgamma agonistic , and alpha-glucosidase inhibitory effects .


Moreover , nettle leaves are used in traditional medicine as an anti-hyperglycemic agent to treat diabetes mellitus .


Thus , efficacy and safety of nettle in the treatment of patients with advanced type 2 diabetes mellitus needing insulin were studied .


In this randomized double-blind placebo-controlled clinical trial , we evaluated the effects of taking nettle leaf extract ( one 500 mg capsule every 8 hours for 3 months ) combined with the conventional oral anti-hyperglycemic drugs on the blood levels of fasting glucose , postprandial glucose , glycosylated hemoglobin ( HbA1c ) , creatinine and liver enzymes SGOT and SGPT , and systolic and diastolic blood pressures in 46 patients and compared with the placebo group ( n = 46 ) .


At the endpoint , the extract lowered the blood levels of fasting glucose , 2 hours postprandial glucose , and HbA1c significantly ( p < 0.001 , p = 0.009 , and p = 0.006 , respectively ) without any significant effects on the other parameters ( p > 0.05 ) compared with placebo .


Nettle may safely improve glycemic control in type 2 diabetic patients needing insulin therapy .


In women with mixed urinary incontinence , pelvic floor muscle training and solifenacin is the recommended conservative treatment , while electroacupuncture is a safe , economical and effective option .


In this prospective , multi-center , randomized controlled trial , five hundred women with mixed urinary incontinence , from 10 centers will be randomized to receive either electroacupuncture or pelvic floor muscle training plus solifenacin .


Women in the acupuncture group will receive electroacupuncture for 3 sessions per week , over 12 weeks , while women in the control group will receive pelvic floor muscle training plus solifenacin ( 5 mg once daily ) for 36 weeks .


The primary outcome measure is the proportion of change in 72-hour incontinence episode frequency from baseline to week 12 .


The secondary outcome measures include eleven items , including proportion of participants with 50 % decrease in average 72-h incontinence episode frequency , change from baseline in the amount of urine leakage and proportion of change from baseline in 72-h incontinence episode frequency in week 25-36 , and so forth .


Statistical analysis will include covariance analysis , nonparametric tests and t tests .


The objective of this trial is to compare the efficacy and safety of electroacupuncture versus pelvic floor muscle training plus solifenacin in women with moderate and severe mixed urinary incontinence .


ClinicalTrials.gov Identifier : NCT02047032 .


In addition to their effects on bone health , high doses of cholecalciferol may have beneficial non-classic effects including the reduction of incidence of type 2 diabetes mellitus , cardiovascular disease , and cancer .


These pleiotropic effects have been documented in observational and experimental studies or in small intervention trials .


Vitamin D insufficiency is a frequent finding in renal transplant recipients ( RTRs ) , and this population is at risk of the previously cited complications .


The VITALE study is a prospective , multicentre , double-blind , randomized , controlled trial with two parallel groups that will include a total of 640 RTRs .


RTRs with vitamin D insufficiency , defined as circulating 25-hydroxyvitamin D levels of less than 30 ng/ml ( or 75 nmol/l ) , will be randomized between 12 and 48 months after transplantation to blinded groups to receive vitamin D3 ( cholecalciferol ) either at high or low dose ( respectively , 100,000 UI or 12,000 UI every 2 weeks for 2 months then monthly for 22 months ) with a follow-up of 2 years .


The primary objective of the study is to evaluate the benefit/risk ratio of high-dose versus low-dose cholecalciferol on a composite endpoint consisting of de novo diabetes mellitus ; major cardiovascular events ; de novo cancer ; and patient death .


Secondary endpoints will include blood pressure ( BP ) control ; echocardiography findings ; the incidences of infection and acute rejection episodes ; renal allograft function using estimated glomerular filtration rate ; proteinuria ; graft survival ; bone mineral density ; the incidence of fractures ; and biological relevant parameters of mineral metabolism .


We previously reported that the intensive cholecalciferol treatment ( 100 000 IU every 2 weeks for 2 months ) was safe in RTR .


Using a pharmacokinetic approach , we showed that cholecalciferol 100,000 IU monthly should maintain serum 25-hydroxyvitamin D at above 30 ng/ml but below 80 ng/ml after renal transplantation .


Taken together , these results are reassuring regarding the safety of the cholecalciferol doses that will be used in the VITALE study .


Analysis of data collected during the VITALE study will demonstrate whether high or low-dose cholecalciferol is beneficial in RTRs with vitamin D insufficiency .


ClinicalTrials.gov Identifier : NCT01431430 .


The aim of the study was to evaluate the effectiveness and safety of 2 different polyethylene glycol ( PEG ) doses for the maintenance treatment of functional constipation in children .


Children with functional constipation according to the Rome III criteria were randomly assigned to receive PEG 4000 at a dose of either 0.7 g/kg ( high-dose group ; n = 45 ) or 0.3 g/kg ( low-dose group ; n = 47 ) for 6 weeks .


Adjustment of the therapy was recommended in the event of < 3 bowel movements ( BM ) per week or 3 BM per day .


The primary outcome measure was treatment success , defined as 3 BM per week with no fecal soiling during the last week of the intervention .


A total of 90 of 92 randomized children , with a mean age of 3.72.1 years , completed the study .


In the analysis based on allocated treatment , treatment success was similar in both groups ( relative risk 0.9 , 95 % confidence interval 0.78-1 .03 ) .


Compared with the high-dose PEG group , the low-dose PEG group had an increased need for therapy adjustment of borderline significance ( relative risk 2.0 , 95 % confidence interval 1.0-4 .2 ) , an increased risk of painful defecation , a lower number of stools per week , and lower parental satisfaction .


Adverse events were similar in both groups .


To achieve treatment success , both tested doses of PEG were equally safe and effective in the treatment of children with functional constipation .


We sought to assess the prognostic role of collaterals in a large population of patients presenting with an acute coronary syndrome ( ACS ) .


The coronary collateral circulation was assessed by an independent angiographic core laboratory using the Rentrop Score in patients enrolled in the randomised Acute Catheterization and Urgent Intervention Triage Strategy trial .


The cohort comprised 5412 patients with moderate to high risk ACS .


A total of 858 patients ( 16.0 % ) had visible collaterals while 4554 patients ( 84.0 % ) had no collaterals .


After multivariable adjustment , there were no differences in clinical outcomes at 1 year between the groups , including major adverse cardiac events ( MACE ) ( HR 0.94 ( 95 % CI 0.76 to 1.16 ) , p = 0.55 ) , mortality ( HR 1.03 ( 0.65 to 1.62 ) , p = 0.91 ) , myocardial infarction ( MI ) ( HR 1.07 ( 0.83 to 1.38 ) , p = 0.60 ) and unplanned target vessel revascularisation ( TVR ) ( HR 0.95 ( 0.71 to 1.28 ) , p = 0.75 ) .


Similarly , in the subgroup of patients undergoing percutaneous coronary intervention ( PCI ) , the adjusted HR for major adverse cardiac events was 1.1 ( 0.76 to 1.61 ) , p = 0.595 ; 0.81 ( 0.10 to 6.44 ) , p = 0.999 for mortality ; and 0.86 ( 0.54 to 1.35 ) , p = 0.564 for MI .


The risk of unplanned TVR was increased ( HR 2.74 ( 1.48 to 5.10 ) , p = 0.004 ) .


In contrast to other studies , this large core laboratory-based analysis does not confirm a beneficial role of visible coronary collateral vessels on clinical outcomes in patients with ACS ; the presence of collaterals was even associated with increased mortality in the unadjusted analysis .


Collaterals were associated with a higher risk of TVR in patients undergoing PCI , a finding that may not have been fully corrected given confounders and clinical differences between the groups .


ClinicalTrials.gov Identifier : NCT00093158 .


The goal of this work was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of calcaneodynia .


Between February 2006 and February 2010 , 457 evaluable patients were recruited for this prospective trial .


All patients received orthovoltage radiotherapy .


One course consisted of 6 fractions/3 weeks .


In case of insufficient remission of pain after 6 weeks a second series was performed .


Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy .


Endpoint was pain reduction .


Pain was measured before , right after ( early response ) , 6 weeks ( delayed response ) , and approximately 2.5 years after radiotherapy ( long-term response ) with a questionnaire-based visual analogue scale ( VAS ) and a comprehensive pain score ( CPS ) .


The median follow-up was 32 months ( range 9-57 months ) .


The overall early , delayed , and long-term response rates for all patients were 87 , 88 , and 95 % .


The mean VAS values before treatment , for early , delayed , and long-term response for the 0.5 and 1.0 Gy groups were 65.522.1 and 64.020.5 ( p = 0.19 ) , 34.824.7 and 39.026.3 ( p = 0.12 ) , 25.126.8 and 28.926.8 ( p = 0.16 ) , and 16.324.3 and 14.119.7 ( p = 0.68 ) .


The mean CPS values before treatment , for early , delayed , and log-term response were 10.12.7 and 10.03.0 ( p = 0.78 ) , 5.63.7 and 6.03.9 ( p = 0.34 ) , 4.04.1 and 4.33.6 ( p = 0.26 ) , and 2.13.3 and 2.33.2 ( p = 0.34 ) , respectively .


No significant differences in long-term response quality between the two arms were found ( p = 0.50 ) .


Radiotherapy is a very effective treatment for the management of benign calcaneodynia .


For radiation protection reasons , the dose for a RT series should not exceed 3.0 Gy .


In the present study , we applied two incisionless suture techniques for otoplasty : Haytoglu et al. 's modification of incisionless otoplasty technique and Fritsch 's incisionless otoplasty technique for correction of prominent ears .


In this prospective study , 60 patients with prominent ears were included in the study .


In Group 1 , 55 ears of 30 patients ( 25 bilateral and 5 unilateral ) were operated with Haytoglu et al. 's modification of incisionless otoplasty technique .


In Group 2 , 57 ears of 30 patients ( 27 bilateral and 3 unilateral ) were operated with Fritsch 's incisionless otoplasty technique .


For comparison of two methods , auriculocephalic distances were measured at three levels which were level 1 ( the most superior point of the auricle ) , level 2 ( the midpoint of the auricle ) and level 3 ( level of the lobule ) pre-operatively ( preop ) ; and measurements were repeated at the end of the surgery ( PO ( 0-day ) ) , 1st month ( PO ( 1-Mo ) ) and 6th month ( PO ( 6-Mo ) ) after the surgery , in both groups .


Patient satisfaction was evaluated using a visual analog scale ( VAS ) .


Moreover , Global Aesthetic Improvement Scale ( GAIS ) was rated by an independent , non-participating plastic surgeon at 6 months after the surgery .


Operation time was 15.95.6 min in Group 1 ( Haytoglu et al. 's ) and 194.7 min in Group 2 ( Fritsch ) .


Hematoma , infection , bleeding , keloid scar formation , sharp edges or irregularities of the cartilage were not observed in any group .


Suture extrusion was detected in 14.03 % of Group 1 and 16.1 % of Group 2 .


No statistically significant difference was observed between auriculocephalic distances at levels 1-3 of groups at preop , PO ( 0-day ) , PO ( 1-Mo ) and PO ( 6-Mo ) separately .


Similarly , difference in auriculocephalic distances ( preop values-PO ( 6-Mo ) values ) was not detected as statistically significant in Groups 1 and 2 at three levels .


In both techniques , No statistically significant difference was observed in patient satisfaction at 6th months after the operation which was measured using Visual Analogue Scale ( VAS ) on 0 to 100 scales .


According to GAIS , the patients were rated as 92.9 % `` improved '' and 7.1 % `` no change '' in Group 1 ; as 94.6 % `` improved '' and 5.4 % `` no change '' in Group 2 .


Due to the similar results , Haytoglu et al. 's and Fritsch 's incisionless otoplasty techniques are good options in the treatment of prominent ears , especially in pediatric patients with isolated inadequate development of antihelical ridge , and with soft auricular cartilage .


Determine if oral treatment with a vasoconstrictor decreases the blood to middle ear exchange rate of the perfusion-limited gas , nitrous oxide ( N2O ) .


Randomized , double-blind , crossover study .


Ten adult subjects with and 10 without past middle ear disease completed paired experimental sessions , identical except for oral treatment with either pseudoephedrine hydrochloride or lactose placebo .


At each session , subjects were fitted with a nonrebreathing mask and breathed room air for 20 minutes ( acclimation period ) , 50 % N2O :50 % O2 for 20 minutes ( experimental period ) , and 100 % O2 for 10 minutes ( recovery period ) .


Throughout , heart rate , blood pressure , and O2 saturation were monitored , and bilateral middle ear pressures were recorded by tympanometry every minute .


The primary outcome was the slope of the middle ear pressure-time function for the experimental period , which estimates the volume N2O exchange rate .


Using repeated measures analysis of variance , the effects of group ( disease history ) , treatment ( active vs. placebo ) , and period ( 1 vs. 2 ) on the recorded vital signs , and of group , treatment , and ear ( left/right ) on the middle ear pressure-time slope were evaluated for statistical significance .


Statistically significant effects of period on O2 saturation ( period 2 > period 1 ) and of treatment on heart rate ( active > placebo ) were documented .


Only treatment was statistically significant for the middle ear pressure-time slope , with a shallower slope characterizing the active treatment session .


The volume exchange rate across the middle ear mucosa of perfusion-limited gases can be modulated pharmacologically .


Theoretically , similar drugs can be used to reduce the requisite eustachian tube opening efficiency for adequate middle ear pressure regulation .


1b .


Pain attitudes and beliefs are hypothesized to influence pain and adjustment to pain .


Valid and reliable measures of these beliefs are necessary to test their hypothesized associations with outcomes .


The Pediatric version of the Survey of Pain Attitudes ( Peds-SOPA ) is a new measure with limited evidence regarding its psychometric properties .


This study sought to : 1 ) evaluate the predictive validity , reliability , and factor structure of the Peds-SOPA ; and 2 ) determine if there are sex - or age-related differences in children 's attitudes toward pain .


Longitudinal study .


Five hundred and sixty-one schoolchildren between 8 and 16 years old participated in this study .


Factor analyses supported the seven-factor structure described by the original authors .


The Peds-SOPA showed acceptable reliability with Cronbach alpha values ranging from 0.68 to 0.80 .


The Peds-SOPA scales also demonstrated prospective predictive validity via their associations with pain intensity , and pain status at 1-year follow-up .


The findings also showed some few sex - and age-specific differences in the Peds-SOPA scores .


The current findings provide additional support for the reliability and validity of the Peds-SOPA , and suggest that children 's pain attitudes and beliefs might be important intervention targets in pain treatment .


This is the third study in a Phase 3 program evaluating onabotulinumtoxinA treatment of crow 's feet lines ( CFL ) .


To assess the efficacy and safety of repeated onabotulinumtoxinA treatments of CFL alone or with glabellar lines ( GL ) in subjects with moderate-to-severe CFL and GL ( maximum smile ) .


This 5-month extension of a 7-month study randomized subjects who originally received onabotulinumtoxinA 24 U ( CFL only ; n = 227 ) or 44 U ( 24 U for CFL + 20 U for GL ; n = 260 ) to retreatment with the same dose .


Placebo-treated subjects were rerandomized to onabotulinumtoxinA 44 U ( n = 101 ) or placebo ( n = 96 ) .


Primary efficacy end point ( Day 30 ) was the proportion of subjects who achieved a CFL severity rating of none or mild ( maximum smile ) on the investigator-assessed Facial Wrinkle Scale ( FWS ) .


Additional efficacy end points and adverse events were evaluated .


Responder rates ( primary end point ) were significantly greater in onabotulinumtoxinA-treated groups ( 24 U : 56.5 % ; 44 U : 63.6 % ; placebo : 1.1 % ; p < .001 ) .


Improvements on most patient-reported outcomes ( PROs ) favored the 44-U group over the 24-U group .


Adverse events did not differ among groups ; most were mild or moderate .


Repeated onabotulinumtoxinA treatments significantly reduce CFL severity based on FWS and PROs .


Adverse event profiles remain consistent with approved GL labeling .


Few randomized clinical trials have investigated antiretroviral regimens in very advanced HIV-1-infected patients .


The objective was to study the immune reconstitution in very immunosuppressed antiretroviral-naive , HIV-1-infected individuals by comparing an efavirenz-based regimen with 2 ritonavir-boosted protease inhibitor regimens .


Randomized , controlled , open-label , multicenter clinical trial .


Eighty-nine HIV-1-infected antiretroviral-naive patients with < 100 CD4 cells per cubic millimeter were randomly assigned in a 1:1:1 ratio to efavirenz ( n = 29 ) , atazanavir/ritonavir ( n = 30 ) , or lopinavir/ritonavir ( n = 30 ) combined with tenofovir plus emtricitabine .


The primary outcome was median increase in CD4 cell count at week 48 .


Secondary end points were the proportion of patients with HIV-1 RNA < 50 copies per milliliter , adverse events , disease progression , and death .


In the on-treatment analysis , the median ( interquartile range ) increase in the CD4 count after 48 weeks was +193 ( 129-349 ) cells per microliter in the efavirenz arm , +197 ( 146-238 ) cells per microliter in the ritonavir-boosted atazanavir arm , and +205 ( 178-327 ) cells per microliter in the ritonavir-boosted lopinavir arm ( P = 0.73 ) .


The percentage of patients achieving viral suppression was similar in all 3 treatment arms at 48 weeks { efavirenz , 85.71 % [ 95 % confidence interval ( CI ) : 68.5 to 94.3 ] ; atazanavir , 80 % [ 95 % CI : 62.7 to 90.5 ] ; and lopinavir , 82.8 % [ 95 % CI : 65.5 to 92.4 ] ; P = 0.88 } .


Bacterial translocation , inflammation , immune activation , and apoptotic markers , but not D-dimer , declined significantly and similarly in the 3 treatment arms .


Adverse events had a similar incidence in all 3 antiretroviral regimens .


No patients died .


The immune reconstitution induced by an efavirenz-based regimen in very advanced HIV-1-infected patients was similar to that induced by a ritonavir-boosted protease inhibitor-based regimen ( ClinicalTrials.gov registration number : NCT00532168 ) .


There is a major unmet need for effective treatments in patients with squamous cell carcinoma of the lung .


LUX-Lung 8 compared afatinib ( an irreversible ErbB family blocker ) with erlotinib ( a reversible EGFR tyrosine kinase inhibitor ) , as second-line treatment for patients with advanced squamous cell carcinoma of the lung .


We did this open-label , phase 3 randomised controlled trial at 183 cancer centres in 23 countries worldwide .


We enrolled adults with stage IIIB or IV squamous cell carcinoma of the lung who had progressed after at least four cycles of platinum-based-chemotherapy .


Participants were randomly assigned ( 1:1 ) to receive afatinib ( 40 mg per day ) or erlotinib ( 150 mg per day ) until disease progression .


The randomisation was done centrally with an interactive voice or web-based response system and stratified by ethnic origin ( eastern Asian vs non-eastern Asian ) .


Clinicians and patients were not masked to treatment allocation .


The primary endpoint was progression-free survival assessed by independent central review ( intention-to-treat population ) .


The key secondary endpoint was overall survival .


This trial is registered with ClinicalTrials.gov , NCT01523587 .


795 eligible patients were randomly assigned ( 398 to afatinib , 397 to erlotinib ) .


Median follow-up at the time of the primary analysis of progression-free survival was 67 months ( IQR 31-102 ) , at which point enrolment was not complete .


Progression free-survival at the primary analysis was significantly longer with afatinib than with erlotinib ( median 24 months [ 95 % CI 19-29 ] vs 19 months [ 19-22 ] ; hazard ratio [ HR ] 082 [ 95 % CI 068-100 ] , p = 00427 ) .


At the time of the primary analysis of overall survival ( median follow-up 184 months [ IQR 138-224 ] ) , overall survival was significantly greater in the afatinib group than in the erloinib group ( median 79 months [ 95 % CI 72-87 ] vs 68 months [ 59-78 ] ; HR 081 [ 95 % CI 069-095 ] , p = 00077 ) , as were progression-free survival ( median 26 months [ 95 % CI 20-29 ] vs 19 months [ 19-21 ] ; HR 081 [ 95 % CI 069-096 ] , p = 00103 ) and disease control ( 201 [ 51 % ] of 398 patients vs 157 [ 40 % ] of 397 ; p = 00020 ) .


The proportion of patients with an objective response did not differ significantly between groups ( 22 [ 6 % ] vs 11 [ 3 % ] ; p = 00551 ) .


Tumour shrinkage occurred in 103 ( 26 % ) of 398 patients versus 90 ( 23 % ) of 397 patients .


Adverse event profiles were similar in each group : 224 ( 57 % ) of 392 patients in the afatinib group versus 227 ( 57 % ) of 395 in the erlotinib group had grade 3 or higher adverse events .


We recorded higher incidences of treatment-related grade 3 diarrhoea with afatinib ( 39 [ 10 % ] vs nine [ 2 % ] ) , of grade 3 stomatitis with afatinib ( 16 [ 4 % ] vs none ) , and of grade 3 rash or acne with erlotinib ( 23 [ 6 % ] vs 41 [ 10 % ] ) .


The significant improvements in progression-free survival and overall survival with afatinib compared with erlotinib , along with a manageable safety profile and the convenience of oral administration suggest that afatinib could be an additional option for the treatment of patients with squamous cell carcinoma of the lung .


Boehringer Ingelheim .


Physicians adopt evidence-based guidelines with variable consistency .


Narratives , or stories , offer a novel dissemination strategy for clinical recommendations .


The study objective was to compare whether evidence-based narrative versus traditional summary improved recall of opioid prescribing guidelines from the American College of Emergency Physicians ( ACEP ) .


This was a prospective , randomized controlled experiment to compare whether narrative versus summary promoted short-term recall of six themes contained in the ACEP opioid guideline .


The experiment was modeled after the free-recall test , an established technique in studies of memory .


At a regional conference , emergency physicians ( EPs ) were randomized to read either a summary of the guideline ( control ) or a narrative ( intervention ) .


The fictional narrative was constructed to match the summary in content and length .


One hour after reading the text , participants listed all content that they could recall .


Two reviewers independently scored the responses to assess recall of the six themes .


The primary outcome was the total number of themes recalled per participant .


Secondary outcomes included the proportion of responses in each study arm that recalled individual themes and the proportion of responses in each arm that contained falsely recalled or extraneous information .


Ninety-five physicians were randomized .


Eighty-two physicians completed the experiment , for a response rate of 86 % .


The mean of the total number of themes recalled per participant was 3.1 in the narrative arm versus 2.0 in the summary arm ( difference = 1.1 , 95 % confidence interval [ CI ] = 0.6 to 1.7 ) .


For three themes , the proportion of responses that recalled the theme was significantly greater in the narrative arm compared to the summary arm , with the differences ranging from 20 % to 51 % .


For one theme , recall was significantly greater in the summary arm .


For two themes , there was no statistically significant difference in recall between the arms .


In the summary arm , 54 % of responses were found to contain falsely recalled or extraneous information versus 21 % of responses in the narrative arm ( difference = 33 % , 95 % CI = 14 % to 53 % ) .


Physicians exposed to a narrative about opioid guidelines were more likely to recall guideline content at 1 hour than those exposed to a summary of the guidelines .


Future studies should examine whether the incorporation of narratives in dissemination campaigns improves guideline adoption and changes clinical practice


Paullinia cupana ( guaran ) is an Amazonian plant that has been previously shown to be effective in treating chemotherapy-related fatigue ( CRF ) in patients with breast cancer .


We aimed to evaluate the efficacy of a purified dry extract of P. cupana ( PC-18 ) in patients with various solid tumors treated with chemotherapy .


We included 40 patients with solid tumors who showed increases in their Brief Fatigue Inventory ( BFI ) questionnaire scores after 1 week of systemic chemotherapy .


PC-18 was administered at 37.5 mg by mouth two times per day ( PO bid ) , starting after 1 week of chemotherapy , for 3 weeks ( induction phase ) .


Patients who had an improvement in or stabilization of their BFI scores were randomized to receive either PC-18 at the same dose or placebo for the following 3 weeks ( maintenance phase ) .


After PC-18 treatment , the BFI fatigue scores improved or stabilized in 36 out of the 40 patients ( mean BFI score difference = 2.503 ; 95 % confidence interval : 1.716-3 .375 , p = .0002 ) .


Three weeks after randomization ( 16 patients on PC-18 and 17 on placebo ) , we observed no significant differences in the BFI , Functional Assessment of Chronic Illness Therapy , Hospital Anxiety and Depression Scale , and Pittsburgh Sleep Quality Index scores between patients randomized to PC-18 versus placebo .


We conclude that the PC-18 extract may be effective for the treatment of CRF in patients with a variety of solid tumors .


A conditioning effect , which was observed in patients who had a beneficial effect of PC-18 on CRF , may explain the better than expected fatigue scores of the placebo-treated patients .


A single session of left prefrontal rTMS has been shown to have analgesic effects , and to reduce post-operative morphine use .


We sought to test these findings in a larger sample , and try and see if multiple sessions had additive analgesic benefit .


108 patients undergoing laparoscopic gastric bypass surgery received two sessions of 10 Hz rTMS ( 110 % of motor threshold ) over the left dorsolateral prefrontal cortex ( one immediately following surgery and one 4 h later ) .


Participants were randomly assigned to receive 2 sessions of real rTMS , 2 sessions of sham , 1 real then 1 sham , or 1 sham then 1 real rTMS treatments .


Patients and study staff were blind to rTMS conditions .


Unlike previous rTMS trials for post-operative pain , no differences emerged between groups with respect to total patient-controlled analgesia usage ( IV hydromorphone ) .


However , despite no difference in IV analgesic usage , subjects that received 2 real rTMS sessions rated both the affective and sensory dimensions of their pain significantly lower than those in the shamsham group at several time points during the post-surgical/post-rTMS period .


This study suggests that left prefrontal rTMS may produce significant analgesic effects in the perioperative setting .


However , further work is needed to understand this effect and attempt to make it clinically useful in light of the lack of effect on PCA hydromorphone use .


Increasing physical activity is an important public-health goal worldwide , but there are few published mediation analyses of physical-activity interventions in low-to-middle-income countries like South Africa undergoing a health transition involving markedly increased mortality from non-communicable diseases .


This article reports secondary analyses on the mediation of a theory-of-planned-behavior-based behavioral intervention that increased self-reported physical activity in a trial with 1181 men in Eastern Cape Province , South Africa .


Twenty-two matched-pairs of neighborhoods were randomly selected .


Within pairs , neighborhoods were randomized to a health-promotion intervention or an attention-matched control intervention with baseline , immediate-post , and 6 - and 12-month post-intervention assessments .


Theory-of-planned-behavior constructs measured immediately post-intervention were tested as potential mediators of the primary outcome , self-reported physical activity averaged over the 6 - and 12-month post-intervention assessments , using a product-of-coefficients approach in a generalized-estimating-equations framework .


Data were collected in 2007-2010 .


Attitude , subjective norm , self-efficacy , and intention were significant mediators of intervention-induced increases in self-reported physical activity .


The descriptive norm , not affected by the intervention , was not a mediator , but predicted increased self-reported physical activity .


The results suggest that interventions targeting theory-of-planned-behavior constructs may contribute to efforts to increase physical activity to reduce the burden of non-communicable diseases among South African men .


To observe the intervention effect of nourishing Xin and Shen method ( NXSM ) on the cognitive function of mild cognitive impairment due to subcortical small vessel disease ( MCI-SSVD ) .


All 54 MCI-SSVD patients came from Department of Traditional Chinese Medicine , Affiliated Union Hospital of Fujian Medical University from June 2010 to August 2013 .


They were randomly assigned to the treatment group ( 28 cases ) and the control group ( 26 cases ) .


Another 33 volunteers were recruited as a healthy control group .


On the basis of targeting risk factors of blood vessels , MCI-SSVD patients were treated respectively with NXSM and donepezil hydrochloride , with the therapeutic course of 12 weeks .


Neuropsychological scales [ mini-mental state examination ( MMSE ) and Montreal cognitive assessment ( MoCA ) ] , and Chinese medical dementia syndrome scales were performed in all subjects , and results were compared among groups or intra-group before and after treatment .


MMSE and MoCA scores of the two treatment groups decreased more , when compared with those of the healthy control group ( P < 0.05 ) .


In particular , MoCA score was significantly decreased ( P < 0.01 ) .


MMSE and MoCA scores of the two treatment groups increased more after treatment than before treatment ( P < 0.05 ) .


But there was no statistical difference in MMSE or MOCA score after treatment between the two groups ( P > 0.05 ) .


Chinese medical dementia syndrome scales decreased more significantly in the treatment group , when compared with before treatment ( P < 0.01 ) .


But there was no statistical difference in Chinese medical dementia syndrome scales in the control group between before and after treatment ( P > 0.05 ) .


Visual spatial and executive function scores or delayed recall scores of the two treatment groups increased more , when compared with the same group before treatment ( P < 0.05 , P < 0.01 ) .


NXSM could effectively improve cognitive functions of MCI-SSVD .


To optimize the therapeutic programs for periarthritis of shoulder treated with acupuncture , moxibustion and kinetohterapy with orthogonal design method adopted .


The orthogonal design table of L8 ( 2 ( 7 ) ) hierarchical principle was used to randomly divide 192 patients of periarthritis of shoulder into 8 groups , 24 cases in each one .


Separately , 4 factors and each different 2 levels were adopted in treatment , named acupuncture timing ( factor A : A , acute stage , A2 adhesion stage ) , acupoint combination ( factor B : B , local acupoints , B2 local acupoints and distal acupoints along meridians ) , filiform needling and warm needling therapy ( factor C : C1 acupuncture with filiform needle , CZ acupuncture with filiform needle and warm needling therapy ) and positive functional exercise ( factor D : D1 without positive functional exercise , D2 with positive functional exercise ) .


The treatment was given once a day , 10 treatments made one session and 2 sessions were required totally .


The time points of observation were the point after 1 session of treatment and after 2 sessions of treatment .


The short-form McGill pain questionnaire ( MPQ ) and shoulder joint motor disturbance score were adopted for evaluation .


In the orthogonal design analysis , taking the hierarchical factors into consideration , the age was considered as the main factor in the evaluation of shoulder pain and shoulder motor disturbance ( P < 0.01 ) , and the shoulder function grade apparently impacted pain evaluation and the efficacy on shoulder motor disturbance ( P < 0.01 ) .


The best combination of 4 factors and 2 levels were A1B1CzD2 and A2 BC2D2 .


SAS statistical analysis showed that at acute stage and adhesion stage , CZ Dz , meaning acupuncture with fifiform needling and warm needling therapy combined with positive functional exercise , is the main factor of the improvements of shoulder motor function ( P < 0.05 ) .


For periarthritis of shoulder at acute stage , the combined therapy of acupuncture at local acupoints , warm needling and positive functional exercise is adopted .


At chronic stage , the combined therapy of acupuncture at local acupoints and distal acupoints , acupuncture with filiform needle and warm needling and positive functional exercise is the best program .


Additionally , in clinical treatment , the patients ' age , sex , shoulder joint function and duration of treatment should be considered comprehensively for the impacts on the efficacy .


Inappropriate drug use has been identified as one of the most important problems affecting the quality of care in older people .


Inappropriate drug use may increase the risk of the occurrence of ` geriatric giants ' such as immobility , instability , incontinence and cognitive impairment .


There are indications that clinical medication reviews ( CMR ) can reduce inappropriate drug use .


However , CMRs have not yet been implemented at a large scale in primary care .


An innovative medication review program in primary care will be developed which tackles the most important obstacles for a large scale implementation of CMRs .


The aim of this study is to assess whether this CMR program is ( cost - ) effective compared with usual general practice care for older patients with geriatric symptoms with regard to quality of life and geriatric symptoms .


A cluster randomised controlled trial will be performed in 20 Dutch general practices including 500 patients .


Patients of 65years and older are eligible if they newly present with pre-specified geriatric symptoms in general practice and chronic use of at least one prescribed drug .


GP practices will be stratified by practice size and randomly allocated to control ( n = 10 ) or intervention group ( n = 10 ) .


The intervention consists of CMRs which will be facilitated and prepared by an expert team consisting of a GP and a pharmacist .


Primary outcome measures are patient 's quality of life and the presence of self-reported geriatric symptoms during a follow-up period of 6months .


Secondary outcomes are costs of healthcare utilisation , feasibility , number of drug related problems , medication adherence and satisfaction with medication .


This study is expected to add evidence on the ( cost - ) effectiveness of an optimally facilitated , prepared and structured CMR in comparison with usual care in older patients who present a geriatric symptom to their GP .


The strength of this study is that it will be conducted in daily clinical practice .


This improves the possibilities to implement the CMRs in the primary care setting on a large scale .


Netherlands Trial register : NTR4264 .


To evaluate the safety and efficacy of various initial strategies of loop diuretic administration in patients with acute decompensated heart failure ( ADHF ) on diuresis , renal function , electrolyte balance and clinical outcomes .


Consecutive patients admitted with ADHF were randomized into three groups - intravenous furosemide infusion + intravenous dopamine , intravenous furosemide bolus in two divided doses and intravenous furosemide continuous infusion alone .


At 48h , the treating physician could adjust the diuretic strategy .


Primary endpoint was negative fluid balance at 24h after admission .


Secondary end points were duration of hospital stay , negative fluid balance at 48 , 72 , 96h , the trend of serum electrolytes , and renal function and 30 day clinical outcome ( death and emergency department visits ) .


Overall ninety patients ( thirty in each group ) were included in the study .


There was a greater diuresis in first 24h ( p = 0.002 ) and a shorter hospital stay ( p = 0.023 ) with the bolus group .


There was no significant difference in renal function and serum sodium and serum potassium levels .


There was no difference in the number of emergency department visits among the three groups .


All three modes of diuretic therapies can be practiced with no difference in worsening of renal function and electrolyte levels .


Bolus dose administration with itsrapid volume loss and shorter hospital stay might be a more effective diuretic strategy .


Missed scheduled HIV appointments lead to increased mortality , resistance to antiretroviral therapy , and suboptimum virological response .


We aimed to assess whether reminders sent to carers by text message , mobile phone call , or concomitant text message and mobile phone call increase attendance at medical appointments for HIV care in a population of children infected with or exposed to HIV in Cameroon .


We also aimed to ascertain the most cost-effective method of mobile-phone-based reminder .


MORE CARE was a multicentre , single-blind , factorial , randomised controlled trial in urban , semi-urban , and rural settings in Cameroon .


Carers of children who were infected with or had been exposed to HIV were randomly assigned electronically in blocks of four and allocated ( 1:1:1:1 ) sequentially to receive a text message and a call , a text message only , a call only , or no reminder ( control ) .


Investigators were masked to group assignment .


Text messages were sent and calls made 2 or 3 days before a scheduled follow-up appointment .


The primary outcomes were efficacy ( the proportion of patients attending a previously scheduled appointment ) and efficiency ( attendance / [ measures of staff working time cost of the reminders ] ) , as a measure of cost-effectiveness .


The primary analysis was by intention to treat .


This study is registered with the Pan African Clinical Trials Register , number PACTR201304000528276 .


The study took place between Jan 28 and May 24 , 2013 .


We randomly assigned 242 adult-child ( carer-patient ) pairs into four groups : text message plus call ( n = 61 ) , call ( n = 60 ) , text message ( n = 60 ) , and control ( n = 61 ) .


54 participants ( 89 % ) in the text message plus call group , 51 ( 85 % ) in the call group , 45 ( 75 % ) in the text message group , and 31 ( 51 % ) in the control group attended their scheduled appointment .


Compared with control , the odds ratios for improvement in the primary efficacy outcome were 75 ( 95 % CI 29-190 ; p < 00001 ) for text message plus call , 55 ( 23-131 ; p = 00002 ) for call , and 29 ( 13-63 ; p = 0012 ) for text message .


No significant differences were seen in comparisons of the three intervention groups with each other , and there was no synergism between text messages and calls .


For the primary efficiency outcome , the mean difference for text message versus text message plus call was 15 ( 95 % CI 07 to 24 ; p = 0002 ) , for call versus text message plus call was 12 ( 07 to 16 ; p < 00001 ) , and for call versus text message was 04 ( -13 to 06 ; p = 047 ) .


Mobile-phone-based reminders of scheduled HIV appointments for carers of paediatric patients in low-resource settings can increase attendance .


The most effective method of reminder was text message plus phone call , but text messaging alone was the most efficient ( ie , cost-effective ) method .


No external funding .


Safe and cost-effective programs for implementing early infant male circumcision ( EIMC ) in Africa need to be piloted .


We present results on a relative cost analysis within a randomized noninferiority trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe .


Between January and June 2013 , male infants who met inclusion criteria were randomized to EIMC through either AccuCirc or Mogen clamp conducted by a doctor , using a 2:1 allocation ratio .


We evaluated the overall unit cost plus the key cost drivers of EIMC using both AccuCirc and Mogen clamp .


Direct costs included consumable and nonconsumable supplies , device , personnel , associated staff training , and environmental costs .


Indirect costs comprised capital and support personnel costs .


In 1-way sensitivity analyses , we assessed potential changes in unit costs due to variations in main parameters , one at a time , holding all other values constant .


The unit costs of EIMC using AccuCirc and Mogen clamp were $ 49.53 and $ 55.93 , respectively .


Key cost drivers were consumable supplies , capacity utilization , personnel costs , and device price .


Unit prices are likely to be lowest at full capacity utilization and increase as capacity utilization decreases .


Unit prices also fall with lower personnel salaries and increase with higher device prices .


EIMC has a lower unit cost when using AccuCirc compared with Mogen clamp .


To minimize unit costs , countries planning to scale-up EIMC using AccuCirc need to control costs of consumables and personnel .


There is also need to negotiate a reasonable device price and maximize capacity utilization .


A number of perioperative risk factors may suppress the immune system and contribute to the development of post-operative complications .


The association between surgical site infection ( SSI ) and other wound-related complications resulting from immunosuppression through either perioperative administration of dexamethasone , pre-operative smoking or alcohol abuse is , however , uncertain .


This study was a post hoc analysis of data from the PROXI randomized trial in 1386 patients who underwent emergency or elective laparotomy .