Main effects and differential effects for subgroups with different educational levels and different levels of readiness to quit were assessed .


During a blind randomized controlled trial , smokers willing to quit within 6 months were assigned to a video computer tailoring group with video messages ( n = 670 ) , a text computer tailoring group with text messages ( n = 708 ) , or to a control condition with short generic text advice ( n = 721 ) .


After 6 months , effects on 7-day point prevalence abstinence and prolonged abstinence were assessed using logistic regression analyses .


Analyses were conducted in 2 samples : ( 1 ) respondents ( as randomly assigned ) who filled in the baseline questionnaire and completed the first session of the program , and ( 2 ) a subsample of sample 1 , excluding respondents who did not adhere to at least one further intervention session .


In primary analyses , we used a negative scenario in which respondents lost to follow-up were classified as smokers .


Complete case analysis and multiple imputation analyses were considered as secondary analyses .


In sample 1 , the negative scenario analyses revealed that video computer tailoring was more effective in increasing 7-day point prevalence abstinence than the control condition ( OR 1.45 , 95 % CI 1.09-1 .94 , P = .01 ) .


Video computer tailoring also resulted in significantly higher prolonged abstinence rates than controls among smokers with a low ( ready to quit within 4-6 months ) readiness to quit ( OR 5.13 , 95 % CI 1.76-14 .92 , P = .003 ) .


Analyses of sample 2 showed similar results , although text computer tailoring was also more effective than control in realizing 7-day point prevalence abstinence .


No differential effects were found for level of education .


Complete case analyses and multiple imputation yielded similar results .


In all analyses , video computer tailoring was effective in realizing smoking cessation .


Furthermore , video computer tailoring was especially successful for smokers with a low readiness to quit smoking .


Text computer tailoring was only effective for sample 2 .


Results suggest that video-based messages with personalized feedback adapted to the smoker 's motivation to quit might be effective in increasing abstinence rates for smokers with diverse educational levels .


Netherlands Trial Register : NTR3102 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3102 ( Archived by WebCite at http://www.webcitation.org/6NS8xhzUV ) .


Ban-Lan-Gen ( BLG ) is a traditional Chinese herbal medicine .


It has been used for the prevention and treatment of virus-related respiratory diseases such as influenza virus infection .


BLG contains some antiviral compounds , but few evidence-based clinical studies have been conducted to assess its efficacy against influenza .


We assessed the effects of BLG ( including efficacy and safety ) on the treatment of seasonal influenza in an evidence-based clinical trial .


We conducted a randomized , double-blinded , oseltamivir - and placebo-controlled , parallel-design clinical trial .


A total of 177 subjects are going to be recruited after satisfying the criteria : ( i ) 18 to 65 years of age ; ( ii ) illness onset within 36 h ; ( 3 ) axillary temperature 38.0 C ; and ( iv ) positive influenza ( type A/B ) virus test .


Subjects will be assigned randomly into three groups in equal proportions : oseltamivir treatment , BLG granule treatment , and placebo treatment .


Each group receives 5-day treatment and is followed up 1 , 3 , 5 , 7 and 21 days later .


Symptoms and patient compliance are recorded , and virus/serum viral antibodies tested .


We will use the primary outcome , secondary outcome , and safety indicators to evaluate the efficacy and safety of BLG granules in the treatment of seasonal influenza .


We have described the first clinical trial for treatment using a single herb against influenza A and B viruses in China .


We will hold a large-scale clinical trial to comprehensively evaluate the effectiveness and safety of BLG against influenza infection based on the results of this pilot study .


And this clinical trial will serve as an example for the study of other traditional herbal medicines in evidence-based clinical trials .


This study has been registered at ClinicalTrials.gov : NCT02232945 ( 3 September 2014 ) .


We evaluated whether a brief , universal , postnatal nurse home-visiting intervention can be implemented with high penetration and fidelity , prevent emergency health care services , and promote positive parenting by infant age 6 months .


Durham Connects is a manualized 4 - to 7-session program to assess family needs and connect parents with community resources to improve infant health and well-being .


All 4777 resident births in Durham , North Carolina , between July 1 , 2009 , and December 31 , 2010 , were randomly assigned to intervention and control conditions .


A random , representative subset of 549 families received blinded interviews for impact evaluation .


Of all families , 80 % initiated participation ; adherence was 84 % .


Hospital records indicated that Durham Connects infants had 59 % fewer infant emergency medical care episodes than did control infants .


Durham Connects mothers reported fewer infant emergency care episodes and more community connections , more positive parenting behaviors , participation in higher quality out-of-home child care , and lower rates of anxiety than control mothers .


Blinded observers reported higher quality home environments for Durham Connects than for control families .


A brief universal home-visiting program implemented with high penetration and fidelity can lower costly emergency medical care and improve family outcomes .


Interruption of the renin-angiotensin-aldosterone system prevents incident diabetes in high-risk individuals , although the mechanism remains unclear .


To test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system or exogenous aldosterone impairs insulin secretion in humans .


We conducted a randomized , blinded crossover study of aldosterone vs vehicle and compared the effects of a low-sodium versus a high-sodium diet .


Academic clinical research center .


Healthy , nondiabetic , normotensive volunteers .


Infusion of exogenous aldosterone ( 0.7 g/kg/h for 12.5 h ) or vehicle during low or high sodium intake .


Low sodium ( 20 mmol/d ; n = 12 ) vs high sodium ( 160 mmol/d ; n = 17 ) intake for 5-7 days .


Change in acute insulin secretory response assessed during hyperglycemic clamps while in sodium balance during a low-sodium vs high-sodium diet during aldosterone vs vehicle .


A low-sodium diet increased endogenous aldosterone and plasma renin activity , and acute glucose-stimulated insulin ( -16.0 5.6 % ; P = .007 ) and C-peptide responses ( -21.8 8.4 % ; P = .014 ) were decreased , whereas the insulin sensitivity index was unchanged ( -1.0 10.7 % ; P = .98 ) .


Aldosterone infusion did not affect the acute insulin response ( +1.8 4.8 % ; P = .72 ) or insulin sensitivity index ( +2.0 8.8 % ; P = .78 ) .


Systolic blood pressure and serum potassium were similar during low and high sodium intake and during aldosterone infusion .


Low dietary sodium intake reduces insulin secretion in humans , independent of insulin sensitivity .


A peripheral nerve stimulus can enhance or suppress the evoked response to transcranial magnetic stimulation ( TMS ) depending on the latency of the preceding peripheral nerve stimulation ( PNS ) pulse .


Similarly , somatosensory afference from the passively moving limb can transiently alter corticomotor excitability , in a phase-dependent manner .


The repeated association of PNS with TMS is known to modulate corticomotor excitability ; however , it is unknown whether repeated passive-movement associative stimulation ( MAS ) has similar effects .


In a proof-of-principal study , using a cross-over design , seven healthy subjects received in separate sessions : ( 1 ) TMS ( 120 % of the resting motor threshold-RMT , optimal site for Flexor Carpi Radialis ) with muscle at rest ; ( 2 ) TMS paired with cyclic passive movement during extension cyclic passive movement ( 400 pairs , 1 Hz ) , with the intervention order randomly assigned .


Normality was tested using the Kolmogorov-Smirnov test , then compared to pre-intervention baseline using repeated measures ANOVA with a Dunnet multiple comparisons test .


MAS led to a progressive and significant decrease in the motor evoked potential ( MEP ) amplitude over the intervention ( R ( 2 ) = 0.6665 , P < 0.0001 ) , which was not evident with TMS alone ( R ( 2 ) = 0.0068 , P = 0.641 ) .


Post-intervention excitability reduction , only present with MAS intervention , remained for 20 min ( 0-10 min = 68.2 4.9 % , P < 0.05 ; 10-20 min = 73.3 9.7 % , P < 0.05 ) .


The association of somatosensory afference from the moving limb with TMS over primary motor cortex in healthy subjects can be used to modulate corticomotor excitability , and may have therapeutic implications .


The objective of this pilot 6-month randomized controlled trial was to determine the effectiveness of an intensive , community-based , group intervention that focused on diet , physical activity , and peer support for reducing weight among urban-dwelling African Americans with comorbid type 2 diabetes and hypertension .


Sixty-one participants were randomized into an intervention or control group .


The 6-month intervention consisted of 18 group sessions led by a dietitian in a community setting and weekly telephone calls from a peer supporter .


The intervention featured culturally tailored nutrition education , behavioral skills training , and social support focused on changes to diet and physical activity .


The control group consisted of two 3-hour group sessions of diabetes self-management education taught by a community health worker .


Outcome measures were assessed at baseline and 6 months .


The primary outcome was achievement of a 5 % weight reduction at 6 months .


A secondary outcome was achievement of a 0.5 percentage-point reduction in hemoglobin A1c ( HbA1c ) .


Groups did not differ in achievement of the weight-loss goal .


Intervention participants lost a mean of 2.8 kg ( P = .01 ) ; control participants did not lose a significant amount of weight .


A greater proportion of intervention ( 50.0 % ) than control ( 21.4 % ) participants reduced HbA1c by 0.5 percentage points or more at 6 months ( P = .03 ) .


The intervention was more effective than usual care ( short-term diabetes education ) at improving glycemic control , but not weight , in low-income African Americans with comorbid diabetes and hypertension .


A community-based 6-month group class with culturally tailored education , behavioral skills training , and peer support can lead to a clinically significant reduction in HbA1c .


Mandibular advancement devices ( MADs ) are used to treat obstructive sleep apnoea-hypopnoea syndrome ( OSAHS ) but evidence is lacking regarding their clinical and cost-effectiveness in less severe disease .


To compare clinical - and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS .


This open-label , randomised , controlled , crossover trial was undertaken at a UK sleep centre .


Adults with Apnoea-Hypopnoea Index ( AHI ) 5 - < 30/h and Epworth Sleepiness Scale ( ESS ) score 9 underwent 6weeks of treatment with three non-adjustable MADs : self-moulded ( SleepPro 1 ; SP1 ) ; semi-bespoke ( SleepPro 2 ; SP2 ) ; fully-bespoke MAD ( bMAD ) ; and 4weeks no treatment .


Primary outcome was AHI scored by a polysomnographer blinded to treatment .


Secondary outcomes included ESS , quality of life , resource use and cost .


90 patients were randomised and 83 were analysed .


All devices reduced AHI compared with no treatment by 26 % ( 95 % CI 11 % to 38 % , p = 0.001 ) for SP1 , 33 % ( 95 % CI 24 % to 41 % ) for SP2 and 36 % ( 95 % CI 24 % to 45 % , p < 0.001 ) for bMAD .


ESS was 1.51 ( 95 % CI 0.73 to 2.29 , p < 0.001 , SP1 ) to 2.37 ( 95 % CI 1.53 to 3.22 , p < 0.001 , bMAD ) lower than no treatment ( p < 0.001 for all ) .


Compliance was lower for SP1 , which was the least preferred treatment at trial exit .


All devices were cost-effective compared with no treatment at a 20,000 / quality-adjusted life year ( QALY ) threshold .


SP2 was the most cost-effective up to 39,800 / QALY .


Non-adjustable MADs achieve clinically important improvements in mild to moderate OSAHS and are cost-effective .


Of those trialled , the semi-bespoke MAD is an appropriate first choice .


ISRCTN02309506 .


Investigate the effect of a brimless interface design compared with ischial ramus containment ( IRC ) of interfaces when using vacuum-assisted suspension ( VAS ) on transfemoral amputees ( TFAs ) .


Randomized experimental crossover .


Household , community , and clinic .


Unilateral TFAs ( N = 12 enrolled , N = 10 analyzed ) .


Mean age : 42.9 years .


Mean residual limb length : 60.3 % of the sound side femur length .


Participants ' mean time as an amputee : 8.3 years and median AMP score : 43 .


( 1 ) IRC VAS interface , and ( 2 ) brimless VAS interface .


Average medial wall height for IRC interfaces was 0.7 cm proximal to the distal-most aspect of the ischial tuberosity ( IT ) .


The medial wall on the brimless design was an average of 3.3 cm distal to the distal-most aspect of the IT .


Spatiotemporal gait parameters , limits of stability , four square step test , and subjective perception using the prosthetic evaluation questionnaire ( PEQ ) .


Step length was significantly improved towards the IRC ( p = 0.04 ) , when calculating degree of asymmetry .


Base of support was significantly narrowed toward the brimless ( p = 0.03 ) .


All subjective measures reached statistical significance in favor of improvement with the brimless design , compared to the IRC .


The brimless design was equivalent to IRC in most gait and balance outcome measures .


However , step length was more symmetrical toward the IRC while base of support was narrowed toward the brimless demonstrating mixed inconsistent performance changes .


Further , the PEQ demonstrated significant subjective improvements in prosthetic related function and quality of life when participants used the brimless design .


Brimless interface design may be a clinically viable choice .


This study assessed changes in cardiovascular disease risk factors among participants in a 12-week behavioral weight loss intervention featuring a commercial format .


132 participants were enrolled in a randomized controlled trial of a 12-week group-based lifestyle intervention that involved two structured food plan conditions .


Of them , 112 ( 100 women and 12 men , mean BMI = 31.44 2.18 kg/m ( 2 ) ) completed the program with post-treatment assessments .


Weight and changes in risk factors ( cholesterol , triglycerides , fasting blood glucose , and blood pressure ) were assessed at pre - and posttreatment .


Additionally , changes for each risk factor were examined among participants with baseline values of risk factors beyond recommended cut points .


With no weight loss differences between conditions , analyses used the combined sample .


Participants lost 3.74 3.16 kg ( 4.37 3.71 % of baseline weight ) , and exhibited significant decreases in triglyceride , total cholesterol and LDL-cholesterol levels .


There were trends toward reductions in fasting glucose , systolic blood pressure , and HDL cholesterol .


Among participants with elevated baseline values , significant reductions were seen on all risk factors , with the exception of HDL cholesterol .


Modest weight loss achieved via a relatively brief , non-intensive intervention using a commercial format can yield significant improvements in cardiovascular disease risk factors , particularly among individuals with initially higher-risk values .


Effective non-invasive ventilation ( NIV ) therapy is dependent on optimal ventilator settings to maximize clinical benefit and patient tolerance .


Intelligent volume-assured pressure support ( iVAPS ) is a hybrid mode of servoventilation , providing constant automatic adjustment of pressure support ( PS ) to achieve a target ventilation determined by the patient 's requirements .


In a randomized crossover trial , we tested the hypothesis that iVAPS , with automated selection of ventilator settings , was non-inferior to standard PS ventilation , with settings determined by an experienced health-care professional , for controlling nocturnal hypoventilation in patients naive to NIV .


Eighteen patients referred to a ventilator clinic with chronic obstructive or restrictive lung disease and newly diagnosed nocturnal hypoventilation ( 10 male , median ( interquartile range ) : age 54 ( 41-61 ) years , mean daytime PaO2 9.25 ( 8.59-10 .31 ) kPa , - PaCO2 6.38 ( 5.93-6 .65 ) kPa were randomized to iVAPS and standard PS .


Polysomnography with transcutaneous CO2 monitoring was performed at baseline and 1 month after each treatment period .


Nightly hours of therapy were recorded by the ventilator .


iVAPS delivered a lower median PS compared with standard PS ( 8.3 ( 5.6-10 .4 ) vs 10.0 ( 9.0-11 .4 ) cmH2 O ; P = 0.001 ) for the same ventilatory outcome ( mean overnight : SpO2 96 ( 95-98 ) vs 96 ( 93-97 ) % ; P = 0.13 and PtcCO2 6.5 ( 5.8-6 .8 ) vs 6.2 ( 5.8-6 .9 ) ; P = 0.54 ) .


There was no difference in outcome between ventilator modes for spirometry , respiratory muscle strength , sleep quality , arousals or O2 desaturation index .


Adherence was greater with iVAPS ( 5:40 ( 4:42 -6:49 ) vs 4:20 ( 2:27 -6:17 ) hh : mm/night ; P = 0.004 ) .


iVAPS servoventilation with automation of ventilation settings is as effective as PS ventilation initiated by a skilled health-care professional in controlling nocturnal hypoventilation and produced better overnight adherence in patients naive to NIV .


To evaluate the risk of documented hypoglycaemia with glimepiride versus linagliptin .


This was an exploratory analysis of data from a 2-year , randomized , double-blind study of the dipeptidyl peptidase-4 inhibitor linagliptin 5mg once daily ( n = 764 ) versus the sulphonylurea glimepiride 1-4mg once daily ( n = 755 ) in patients with type 2 diabetes uncontrolled by metformin .


Patients randomized to glimepiride started on 1mg and after 4weeks were allowed to be individually uptitrated stepwise to glimepiride 4mg if a fasting plasma glucose concentration 6.1 mmol/l was not achieved .


Investigator-reported hypoglycaemia was evaluated by dose , over time , and by the degree of glycated haemoglobin ( HbA1c ) reduction .


The percentages of patients with at least one hypoglycaemic event at the individual maximum glimepiride dose were : 1mg , 45.0 % ; 2mg , 50.8 % ; 3mg , 36.1 % ; and 4mg , 27.7 % .


The incidence of hypoglycaemia was higher with glimepiride than with linagliptin ( 36.1 vs. 7.5 % ; p < 0.0001 ) ; after performing sensitivity analyses by excluding events during dose escalation ( weeks0-16 ) , this difference remained significant ( weeks16-104 : 25.8 vs. 5.9 % ; p < 0.0001 ) .


Notably , the incidence of hypoglycaemia was higher with glimepiride than with linagliptin in each quartile of HbA1c change from baseline ( all p < 0.0001 ) ; the incidence of hypoglycaemic episodes was not increased with greater reductions in HbA1c in either group .


In all 4-week intervals across the 2-year study , the incidence of hypoglycaemia was lower with linagliptin than with glimepiride .


Linagliptin was associated with a lower risk of hypoglycaemia than glimepiride at all dose levels and time intervals , and regardless of change in HbA1c level .


IgE-mediated allergic rhinitis to grass pollen can successfully be treated with either allergen immunotherapy tablets ( SLIT tablet ) or SQ-standardized subcutaneous immunotherapy ( SCIT ) .


The efficacy of these two treatment modalities for grass allergy is comparable , but the immunological mechanisms may differ .


ClinicalTrials.gov ID : NCT01889875 .


To compare the immunological changes induced by SQ-standardized SCIT and SLIT tablet .


We randomized 40 individuals with grass pollen rhinitis into groups receiving SCIT , SLIT tablet , or neither and followed them for 15 months with regular serum measurements of specific IgE , IgG4 , IgE-blocking factor , facilitated antigen presentation ( FAP ) , and basophil activation test ( BAT ) .


Nasal challenges were used to assess changes in nasal sensitivity .


After 15 months of treatment IgG4 , IgE-blocking factor , FAP , and BAT values differed significantly in both SCIT and SLIT-tablet treatment groups when compared to the control group .


Both SCIT and SLIT-tablet groups were significantly different from the control group after 13 months of treatment .


In general , the changes induced by SCIT reached twice that of SLIT tablet , with the exception of specific IgE where SLIT tablet induced initial threefold increase compared with SCIT .


A slight but significant increase in IgE and BAT after season was seen only in the control group .


Significant differences between SCIT and SLIT tablet were observed early , but the differences diminished with the length of treatment , especially for FAP inhibition .


Both SCIT and SLIT tablet induce significant changes in specific antibodies ( IgE and IgG4 ) and competition assays ( IgE-blocking factor , FAP , and BAT ) .


Overall , SCIT induced larger ( two - to threefold ) changes than SLIT tablet , with the exception of FAP , where SLIT tablet showed a gradual increase ending at the same level as SCIT .


Maximal change was generally reached after 3 months ' treatment .


Painful diabetic peripheral neuropathy ( PDPN ) is a common complication of diabetes mellitus .


Unfortunately , pharmacological treatment is often partially effective or accompanied by unacceptable side effects , and new treatments are urgently needed .


Small observational studies suggested that spinal cord stimulation ( SCS ) may have positive effects .


We performed a multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy .


Twenty-two patients were randomly assigned to SCS in combination with the best medical treatment ( BMT ) ( SCS group ) and 14 to BMT only ( BMT group ) .


The SCS system was implanted only if trial stimulation was successful .


Treatment success was defined as 50 % pain relief during daytime or nighttime or '' ( very ) much improved '' for pain and sleep on the patient global impression of change ( PGIC ) scale at 6 months .


Trial stimulation was successful in 77 % of the SCS patients .


Treatment success was observed in 59 % of the SCS and in 7 % of the BMT patients ( P < 0.01 ) .


Pain relief during daytime and during nighttime was reported by 41 and 36 % in the SCS group and 0 and 7 % in the BMT group , respectively ( P < 0.05 ) .


Pain and sleep were '' ( very ) much improved '' in 55 and 36 % in the SCS group , whereas no changes were seen in the BMT group , respectively ( P < 0.001 and P < 0.05 ) .


One SCS patient died because of a subdural hematoma .


Treatment success was shown in 59 % of patients with PDPN who were treated with SCS over a 6-month period , although this treatment is not without risks .


Direct-to-consumer ( DTC ) genetic tests have facilitated easy access to personal genetic information related to health and nutrition ; however , consumer perceptions of the nutritional information provided by these tests have not been evaluated .


The objectives of this study were to assess individual perceptions of personalized nutrition and genetic testing and to determine whether a personalized nutrition intervention modifies perceptions .


A double-blind , parallel-group , randomized controlled trial was conducted among healthy men and women aged 20-35 years ( n = 138 ) .


Participants in the intervention group ( n = 92 ) were given a report of DNA-based dietary advice and those in the control group ( n = 46 ) were given a general dietary advice report .


A survey was completed at baseline and 3 and 12 months after distributing the reports to assess perceptions between the two groups .


No significant differences in perceptions of personalized nutrition and genetic testing were observed between the intervention and control group , so responses of both groups were combined .


As compared to baseline , participant responses increased significantly toward the positive end of a Likert scale at 3 months for the statement ' I am interested in the relationship between diet and genetics ' ( mean change SD : 0.28 0.99 , p = 0.0002 ) .


The majority of participants indicated that a university research lab ( 47 % ) or health care professional ( 41 % ) were the best sources for obtaining accurate personal genetic information , while a DTC genetic testing company received the fewest selections ( 12 % ) .


Most participants ( 56 % ) considered dietitians to be the best source of personalized nutrition followed by medical doctors ( 27 % ) , naturopaths ( 8 % ) and nurses ( 6 % ) .


These results suggest that perceptions of personalized nutrition changed over the course of the intervention .


Individuals view a research lab or health care professional as better providers of genetic information than a DTC genetic testing company , and registered dietitians are considered to be the best providers of personalized nutrition advice .


Until now , there has not been any evaluated , disease-specific education and treatment program for patients with coronary heart disease ( CHD ) in Germany .


It is thought that education can improve these patients ' physical activity and quality of life and teach them how to lessen their risk factors , what to do in case of an emergency , and how to assess their own medical treatment .


A randomized controlled open intervention trial was carried out from February 2010 to September 2011.196 patients were assigned to receive the intervention ( patient education ) , while 199 were assigned to a control group .


In an intention-to-treat analysis , baseline and follow-up data were compared after a mean interval of 220 days .


The evaluative instruments included the Freiburg Questionnaire of Physical Activity , the MacNew Heart Disease Quality of Life Questionnaire , questionnaires regarding knowledge about CHD , ergometric performance ability , and the body-mass index .


The patients in the intervention group reported having increased their physical activity by a mean of 9.3 MET/week ( MET = metabolic equivalent of task ) , compared to 2.5 MET/week in the control group ; the difference of 6.8 MET/week was statistically significant ( p = 0.015 ) .


The patients in the intervention group also rated their quality of life higher than those in the control group ( 0.2 0.56 vs. 0.09 0.53 [ mean standard deviation ] , p = 0.056 ) .


They were significantly better informed than patients in the control group about risk factors and about what to do in an emergency .


Persistently unhealthy lifestyle is a common problem of CHD patients ; the education and treatment program presented here may be a suitable means of improving patients ' lifestyle for secondary prevention .


Further studies will be needed to document long-term efficacy and to determine whether occasional refresher courses will be needed as well .


The present study aimed to compare the outcome of secondary cytoreductive surgery retrospectively in patients with positive and negative Arbeitsgemeinschaft Gynkologische Onkologie ( AGO ) score that were operated on at the Department of Gynecology , Charit Comprehensive Cancer Center , Medical University , between 2006 and 2013 .


A total of 209 consecutive patients presenting a first recurrence of epithelial ovarian cancer were enrolled : 139 patients had a positive AGO score , and 70 patients had at least one negative criterion of the AGO score .


All patients underwent secondary cytoreductive surgery and data were evaluated retrospectively .


Total macroscopic tumor resection was obtained during secondary cytoreductive surgery in 127 patients ( 61 % ) , 93 ( 67 % ) in the AGO-positive group and 34 ( 48.5 % ) in the AGO-negative group .


Overall ( OS ) and progression-free survival ( PFS ) were identical in both groups of patients when secondary cytoreductive surgery succeeded in achieving complete tumor resection .


PFS was 22 months in AGO-positive patients who were tumor-free after secondary cytoreductive surgery and 21 months in AGO-negative patients with complete resection after secondary cytoreductive surgery .


There were no significant differences in morbidity and mortality rates for both groups .


AGO score is a useful predictor for operability in patients with a first recurrence of ovarian cancer .


Patients with negative scores may still have a 50 % chance of achieving optimal tumor resection after secondary cytoreductive surgery .


This will be a pivotal factor when counseling patients with recurrent disease regarding further management options .


Obsessive-Compulsive Disorder ( OCD ) is a common chronic psychiatric disorder that constitutes a leading cause of disability .


Although Cognitive-Behaviour Therapy ( CBT ) has been shown to be an effective treatment for OCD , this specialised treatment is unavailable to many due to access issues and the social stigma associated with seeing a mental health specialist .


Internet-based psychological treatments have shown to provide effective , accessible and affordable treatment for a range of anxiety disorders , and two Randomised Controlled Trials ( RCTs ) have demonstrated the efficacy and acceptability of internet-based CBT ( iCBT ) for OCD , as compared to waitlist or supportive therapy .


Although these initial findings are promising , they do not isolate the specific effect of iCBT .


This paper details the study protocol for the first randomised control trial evaluating the efficacy of therapist-assisted iCBT for OCD , as compared to a matched control intervention ; internet-based therapist-assisted progressive relaxation training ( iPRT ) .


It will aim to examine whether therapist-assisted iCBT is an acceptable and efficacious treatment , and to examine how effectiveness is influenced by patient characteristics .


A randomised controlled trial using repeated measures with two arms ( intervention and matched control ) will be used to evaluate the efficacy and acceptability of iCBT for OCD .


The RCT will randomise 212 Australian adults with a primary diagnosis of OCD into either the active intervention or control condition , for 12 weeks duration .


Outcomes for participants in both study arms will be assessed at baseline and post-intervention .


Participants in iCBT will be further assessed at six month follow-up , while participants in the control condition will be crossed over to receive the iCBT intervention and reassessed at post-intervention and six month follow-up .


The primary outcome will be clinically significant change in obsessive-compulsive symptom scores .


This will be the first known therapist assisted internet-based trial of a comprehensive CBT treatment for OCD as compared to a matched control intervention .


Demonstrating the efficacy of an internet-based treatment for OCD will allow the development of models of care for broad-based access to an evidence-based but complex treatment .


To observe the differences in clinical effect on menstrual migraine between subgaleal acupoint injection with metoclopramide and oral administration of medication .


Sixty-four patients of menstrual migraine were randomized into a subgaleal acupoint injection group and a medication group , 32 cases in each one .


In the subgaleal acupoint injection group , the acupoint injection started 10 days before menstruation .


Eight acupoints on the head were selected and injected alternatively in two groups , once every 2 days , 4 treatments made one session and 3 sessions ( 3 menstrual cycles ) were required .


In the medication group , flunarizine was applied with oral administration , 2.5 mg each time , once every night .


The duration of treatment was 3 months .


The analgesic effect , frequency and time of pain attack were observed in 3 and 6 months after treatment in the two groups .


After treatment , VAS scores were lower than those before treatment in the two groups ( P < 0.01 , P < 0.05 ) , the attack frequency and pain time were all reduced as compared with those before treatment ( all P < 0.01 ) .


After treatment , VAS score , the frequency and time of pain attack in the subgaleal acupoint injection group were improved significantly as compared with the medication group ( all P < 0.01 ) .


The subgaleal acupoint injection with metoclopramide achieves the superior preventive effect in clinical treatment of menstrual migraine as compared with flunarizine .


The aim of this study was to compare the effectiveness of a new index of perceived mental workload , the Multiple Resource Questionnaire ( MRQ ) , with the standard measure of workload used in the study of vigilance , the NASA Task Load Index ( NASA-TLX ) .


The NASA-TLX has been used extensively to demonstrate that vigilance tasks impose a high level of workload on observers .


However , this instrument does not specify the information-processing resources needed for task performance .


The MRQ offers a tool to measure the workload associated with vigilance assignments in which such resources can be identified .


Two experiments were performed in which factors known to influence task demand were varied .


Included were the detection of stimulus presence or absence , detecting critical signals by means of successive-type ( absolute judgment ) and simultaneous-type ( comparative judgment ) discriminations , and operating under multitask vs. single-task conditions .


The MRQ paralleled the NASA-TLX in showing that vigilance tasks generally induce high levels of workload and that workload scores are greater in detecting stimulus absence than presence and in making successive as compared to simultaneous-type discriminations .


Additionally , the MRQ was more effective than the NASA-TLX in reflecting higher workload in the context of multitask than in single-task conditions .


The resource profiles obtained with MRQ fit well with the nature of the vigilance tasks employed , testifying to the scale 's content validity .


The MRQ may be a meaningful addition to the NASA-TLX for measuring the workload of vigilance assignments .


By uncovering knowledge representation associated with different tasks , the MRQ may aid in designing operational vigilance displays .


The effects of less-tight versus tight control of hypertension on pregnancy complications are unclear .


We performed an open , international , multicenter trial involving women at 14 weeks 0 days to 33 weeks 6 days of gestation who had nonproteinuric preexisting or gestational hypertension , office diastolic blood pressure of 90 to 105 mm Hg ( or 85 to 105 mm Hg if the woman was taking antihypertensive medications ) , and a live fetus .


Women were randomly assigned to less-tight control ( target diastolic blood pressure , 100 mm Hg ) or tight control ( target diastolic blood pressure , 85 mm Hg ) .


The composite primary outcome was pregnancy loss or high-level neonatal care for more than 48 hours during the first 28 postnatal days .


The secondary outcome was serious maternal complications occurring up to 6 weeks post partum or until hospital discharge , whichever was later .


Included in the analysis were 987 women ; 74.6 % had preexisting hypertension .


The primary-outcome rates were similar among 493 women assigned to less-tight control and 488 women assigned to tight control ( 31.4 % and 30.7 % , respectively ; adjusted odds ratio , 1.02 ; 95 % confidence interval [ CI ] , 0.77 to 1.35 ) , as were the rates of serious maternal complications ( 3.7 % and 2.0 % , respectively ; adjusted odds ratio , 1.74 ; 95 % CI , 0.79 to 3.84 ) , despite a mean diastolic blood pressure that was higher in the less-tight-control group by 4.6 mm Hg ( 95 % CI , 3.7 to 5.4 ) .


Severe hypertension ( 160/110 mm Hg ) developed in 40.6 % of the women in the less-tight-control group and 27.5 % of the women in the tight-control group ( P < 0.001 ) .


We found no significant between-group differences in the risk of pregnancy loss , high-level neonatal care , or overall maternal complications , although less-tight control was associated with a significantly higher frequency of severe maternal hypertension .


( Funded by the Canadian Institutes of Health Research ; CHIPS Current Controlled Trials number , ISRCTN71416914 ; ClinicalTrials.gov number , NCT01192412 . )


The menopausal transition ( MT ) is a biological inevitability for all ageing women that can be associated with changes in mood , including depressive symptoms .


There is tentative evidence that women who develop depression during the MT have greater risk of subsequent depressive episodes , as well as increased health morbidity and mortality .


Thus , preventing depression during the MT could enhance both current and the future health and well-being of women .


This study aims to test the efficacy of a client-centred health promotion intervention to decrease the 12-month incidence of clinically significant symptoms of depression among women undergoing the MT.


This randomised controlled trial will recruit 300 women undergoing the MT living in the Perth metropolitan area .


They will be free of clinically significant symptoms of depression and of psychotic or bipolar disorders .


Consenting participants will be stratified for the presence of subsyndromal symptoms of depression and then randomly assigned to the intervention or control group .


The intervention will consist of eight telephone health promotion sessions that will provide training in problem solving and education about the MT , healthy ageing , depression and anxiety , and management of chronic health symptoms and problems .


The primary outcome of interest is the onset of a major depressive episode according the DSM-IV-TR criteria during the 12-month follow-up or of clinically significant symptoms of depression , as established by a score of 15 or greater on the Patient Health Questionnaire ( PHQ-9 ) .


Secondary outcomes of interest include changes in the severity of symptoms of depression and anxiety ( Hospital Anxiety and Depression Scale , HADS ) , quality of life ( Short Form Health Survey , SF-12 ) , and lifestyle .


Current evidence shows that depressive symptoms and disorders are leading causes of disability worldwide , and that they are relatively common during the MT. This study will use a multifaceted health promotion intervention with the aim of preventing depression in these women .


If successful , the results of this trial will have implications for the management of women undergoing the MT.


Australian and New Zealand Clinical Trials Registry ACTRN12613000724774 .


Date registered : 1 July 2013 .


The UK has one of the highest fatality rates for deaths from fire-related injuries in children aged 0-14years ; these injuries have the steepest social gradient of all injuries in the UK .


Children 's centres provide children under five years old and their families with a range of services and information , including home safety , but their effectiveness in promoting injury prevention has yet to be evaluated .


We developed a fire prevention intervention for use in children 's centres comprising an Injury Prevention Briefing ( IPB ) which provides evidence on what works and best practice from those running injury prevention programmes , and a facilitation package to support implementation of the IPB .


This protocol describes the design and methods of a trial evaluating the effectiveness and cost-effectiveness of the IPB and facilitation package in promoting fire prevention .


Pragmatic , multicentre cluster randomised controlled trial , with a nested qualitative study , in four study centres in England .


Children 's centres in the most disadvantaged areas will be eligible to participate and will be randomised to one of three treatment arms comprising : IPB with facilitation package ; IPB with no facilitation package ; usual care ( control ) .


The primary outcome measure will be the proportion of families who have a fire escape plan at follow-up .


Eleven children 's centres per arm are required to detect an absolute difference in the percentage of families with a fire escape plan of 20 % in either of the two intervention arms compared with the control arm , with 80 % power and a 5 % significance level ( 2-sided ) , an intraclass correlation coefficient of 0.05 and assuming outcomes are assessed on 20 families per children 's centre .


Secondary outcomes include the assessment of the cost-effectiveness of the intervention , other fire safety behaviours and factors associated with degree of implementation of the IPB .


This will be the first trial to develop and evaluate a fire prevention intervention for use in children 's centres in the UK .


Its findings will be generalisable to children 's centres in the most disadvantaged areas of the UK and may also be generalisable to similar interventions to prevent other types of injury .


http://NCT01452191 ( date of registration : 13/10/2011 ) .


The Cornea Donor Study ( CDS ) showed that donor age is not a factor in survival of most penetrating keratoplasties for endothelial disease .


Secondary analyses confirm the importance of surgical indication and presence of glaucoma in outcomes at 10 years .


To assess the relationship between donor and recipient factors and corneal graft survival in the CDS .


Multicenter prospective , double-masked , controlled clinical trial conducted at 80 clinical sites .


One hundred five surgeons enrolled 1090 participants undergoing corneal transplant for a moderate-risk condition , principally Fuchs dystrophy or pseudophakic or aphakic corneal edema ( PACE ) .


Forty-three eye banks provided corneas .


Corneas from donors younger than 66 years and donors 66 years or older were assigned , masked to donor age .


Surgery and postoperative care were performed according to the surgeons ' usual routines .


Participants were followed up for as long as 12 years .


Graft failure , defined as a regrafting procedure or a cloudy cornea for 3 consecutive months .


The 10-year cumulative probability of graft failure was higher in participants with PACE than in those with Fuchs dystrophy ( 37 % vs 20 % ; hazard ratio [ HR ] , 2.1 [ 99 % CI , 1.4-3 .0 ] ; P < .001 ) and in participants with a history of glaucoma before penetrating keratoplasty , particularly with prior glaucoma surgery ( 58 % with prior glaucoma surgery and use of medications to lower intraocular pressure at the time of surgery vs 22 % with no history of glaucoma surgery or medication use ; HR , 4.1 [ 99 % CI , 2.2-7 .5 ] ; P < .001 ) .


We found trends toward increased graft failure in recipients who were 70 years or older compared with those younger than 60 years ( 29 % vs 19 % ; HR , 1.2 [ 99 % CI , 0.7-2 .1 ] ; P = .04 ) or were African American ( HR , 1.5 ; P = .11 ) or who had a history of smoking ( 35 % vs 24 % ; HR , 1.6 [ 99 % CI , 0.9-2 .8 ] ; P = .02 ) .


Lower endothelial cell density ( ECD ) and higher corneal thickness ( CT ) at 6 months ( 6 % vs 41 % for ECD 2700 vs < 1700 cells/mm2 [ P < .001 ] ; 14 % vs 36 % for CT < 500 vs 600 m [ P = .001 ] ) , 1 year ( 4 % vs 39 % for ECD 2700 vs < 1700 cells/mm2 [ P < .001 ] ; 18 % vs 28 % for CT < 500 vs 600 m [ P = .04 ] ) , and 5 years ( 2 % vs 29 % for ECD 1500 vs < 500 cells/mm2 [ P < .001 ] ; 7 % vs 34 % for CT < 550 vs 650 m [ P < .001 ] ) were associated with subsequent graft failure .


Most penetrating corneal grafts for Fuchs dystrophy or PACE remain clear at 10 years .


The risk for failure is greater for graft recipients with PACE and those with a history of glaucoma .


Measurements of ECD and CT during the course of postkeratoplasty follow-up are associated with a risk for failure .


However , even with very low ECD and high CT at 5 years , most corneas remain clear at 10 years .


Digital nerve blocks are commonly used as effective techniques of anaesthesia to allow a variety of surgical procedures performed on digits .


This study was conducted to compare the efficacy of volar subcutaneous single injection block and the traditional dorsal two injections digital block .


This randomized controlled trial was conducted at Plastic and Reconstructive Surgery Department , Hayatabad Medical Complex Peshawar from December .


2009-10 .


A total of 126 patients with pathology distal to the first palmer digital crease divided into two equal groups .


Group A received volar subcutaneous digital block while group B dorsal two injections block .


Efficacy of digital block was measured in terms of time of onset of anaesthesia , which was the total time duration after administering local anaesthetic to loss of pinprick sensation and total duration of anaesthesia , which was defined as the time period from onset of block ( loss of pinprick sensation ) till the appearance of pain which required additional local anaesthetic or postoperative analgesia .


A total of 126 patients were studied , 63 in each group .


Of the total patients , 102 ( 81 % ) were male and 24 ( 19 % ) female with a mean age of 27 4.2 years ( range 17-60 years ) .


The mean time of onset of anaesthesia from injection till the loss of pin prick sensation was 3.32 0.42 minutes for volar single injection group and 4.53 minutes 0.57 minutes for dorsal two injections group ( p = 0.049 ) .


Similarly the mean total duration of anaesthesia for the volar subcutaneous group was 271.9 29.34 minutes while for the dorsal two injections group , it was 229.52 28.82 minutes ( p = 0.415 ) .


Single injection volar subcutaneous digital block provides faster onset of anaesthesia , produces predictable , consistent dense anaesthesia of all of the fingers with the help of single injection prick .


Pain is underrecognized and undermanaged in older adults with dementia .


Because dementia patients have a diminished capacity to communicate discomfort , untreated pain may be expressed in the form of behavioral and psychiatric symptoms .


The goal of the present study was to examine the relationship between pain and behavioral and psychiatric symptoms of dementia in community-residing older adults from the perspective of the family caregiver .


Dyads composed of 272 dementia patients , and their family caregivers were assessed to determine dementia patient 's mental status ; family caregiver 's assessment of care recipient 's pain , functional dependence , and number of behavioral symptoms ; analgesic use ; and demographic information .


Hierarchical multiple regression analysis controlling for age , marital status , race , functional disability , and analgesic use showed that pain explained a small but significant percent of variance in the number of behavioral symptoms ( 3 % , P < 0.001 ) .


Pain had a stronger influence on the number of behavioral and psychiatric symptoms of dementia among those with severe cognitive impairment ( F1 ,69 = 11.75 , P < 0.001 ) compared with those with low to moderate cognitive impairment ( F1 ,199 = 4.543 , P = 0.034 . )


The findings indicate that pain is a risk factor for behavioral symptoms in individuals with dementia and suggest that pain is a more significant predictor of behavior for individuals with severe dementia , compared with those with mild/moderate stage dementia .


These results reinforce the importance of proper pain assessment and its management as part of dementia care planning .


T-cell infiltration in estrogen receptor ( ER ) - negative breast tumours has been associated with longer survival .


To investigate this association and the potential of tumour T-cell infiltration as a prognostic and predictive marker , we have conducted the largest study of T cells in breast cancer to date .


Four studies totalling 12 439 patients were used for this work .


Cytotoxic ( CD8 + ) and regulatory ( forkhead box protein 3 , FOXP3 + ) T cells were quantified using immunohistochemistry ( IHC ) .


IHC for CD8 was conducted using available material from all four studies ( 8978 samples ) and for FOXP3 from three studies ( 5239 samples ) - multiple imputation was used to resolve missing data from the remaining patients .


Cox regression was used to test for associations with breast cancer-specific survival .


In ER-negative tumours [ triple-negative breast cancer and human epidermal growth factor receptor 2 ( human epidermal growth factor receptor 2 ( HER2 ) positive ) ] , presence of CD8 + T cells within the tumour was associated with a 28 % [ 95 % confidence interval ( CI ) 16 % to 38 % ] reduction in the hazard of breast cancer-specific mortality , and CD8 + T cells within the stroma with a 21 % ( 95 % CI 7 % to 33 % ) reduction in hazard .


In ER-positive HER2-positive tumours , CD8 + T cells within the tumour were associated with a 27 % ( 95 % CI 4 % to 44 % ) reduction in hazard .


In ER-negative disease , there was evidence for greater benefit from anthracyclines in the National Epirubicin Adjuvant Trial in patients with CD8 + tumours [ hazard ratio ( HR ) = 0.54 ; 95 % CI 0.37-0 .79 ] versus CD8-negative tumours ( HR = 0.87 ; 95 % CI 0.55-1 .38 ) .


The difference in effect between these subgroups was significant when limited to cases with complete data ( P heterogeneity = 0.04 ) and approached significance in imputed data ( P heterogeneity = 0.1 ) .


The presence of CD8 + T cells in breast cancer is associated with a significant reduction in the relative risk of death from disease in both the ER-negative [ supplementary Figure S1 , available at Annals of Oncology online ] and the ER-positive HER2-positive subtypes .


Tumour lymphocytic infiltration may improve risk stratification in breast cancer patients classified into these subtypes .


NEAT ClinicalTrials.gov : NCT00003577 .


To study the influence of adjuvant androgen suppression and bisphosphonates on incident vertebral and non-spinal fracture rates and bone mineral density ( BMD ) in men with locally advanced prostate cancer .


Between 2003 and 2007 , 1071 men with locally advanced prostate cancer were randomly allocated , using a 2 2 trial design , to 6 months i.m. leuprorelin ( androgen suppression [ AS ] ) before radiotherapy alone 12 months additional leuprorelin 18 months zoledronic acid ( ZdA ) , commencing at randomization .


The main endpoint was incident thoraco-lumbar vertebral fractures , which were assessed radiographically at randomization and at 3 years , then reassessed by centralized review .


Subsidiary endpoints included incident non-spinal fractures , which were documented throughout follow-up , and BMD , which was measured in 222 subjects at baseline , 2 years and 4 years .


Incident vertebral fractures at 3 years were observed in 132 subjects .


Their occurrence was not increased by 18 months ' AS , nor reduced by ZdA .


Incident non-spinal fractures occurred in 72 subjects and were significantly related to AS duration but not to ZdA .


Osteopenia and osteoporosis prevalence rates at baseline were 23.4 and 1.4 % , respectively , at the hip .


Treatment for 6 and 18 months with AS caused significant reductions in hip BMD at 2 and 4 years ( P < 0.01 ) and ZdA prevented these losses at both time points .


In an AS-nave population , 18 months of ZdA treatment prevented the sustained BMD losses caused by 18 months of AS treatment ; however , the study power was insufficient to show that AS duration or ZdA influenced vertebral fracture rates .


Febrile neutropenia ( FN ) is a common and serious complication of cancer chemotherapy associated with significant morbidity and mortality .


Cefozopran ( CZOP ) is a potential candidate for empirical monotherapy in FN .


However , studies on the use of CZOP as empirical treatment for pediatric patients with FN are quite limited .


The purpose of this study was to compare the efficacy and safety of CZOP with cefepime ( CFPM ) empirical monotherapy in pediatric cancer patients with FN .


A total of 64 patients with 224 episodes of FN were randomly assigned to receive antibiotic therapy with either CZOP ( 100 mg/kg/day ) or CFPM ( 100 mg/kg/day ) .


Of these episodes , 223 were considered eligible for the study .


Success was defined as resolution of febrile episodes and clinical signs of infection within 120 hr following the start of antibiotic therapy .


The success rate was not significantly different between the CZOP ( 64.0 % ) and CFPM ( 56.3 % ) groups ( P = 0.275 ) .


Duration of fever , duration of antibiotic therapy , and the success rate in patients with blood stream infection did not differ between the two groups .


There was no infection-related mortality in the study period .


Both CZOP and CFPM as monotherapy appear to be effective and safe in pediatric patients .


This study suggests that CZOP has satisfactory efficacy and is well tolerated as initial empirical therapy for pediatric cancer patients with FN .


Obstructive sleep apnea ( OSA ) relates to overnight rostral fluid shift , possibly because fluid accumulation around the pharynx increases pharyngeal resistance ( Rph ) .


We hypothesised that Rph will increase more in men with than without OSA in response to rostral fluid redistribution .


Seventeen men with , and 12 without OSA were randomized to lower body positive pressure ( LBPP ) for 15min or control , then crossed over .


Leg fluid volume ( LFV ) and Rph were measured before and after each period .


LBPP displaced similar amounts of fluid from the legs in both groups .


However , compared to the non-OSA group , Rph increased significantly more during LBPP in the OSA group ( -0.382.87 vs. 2.522.94 cmH2O/l/s , p = 0.016 ) .


Change in Rph during LBPP correlated directly with baseline Rph in the OSA group , but inversely in the non-OSA group .


OSA patients have increased susceptibility to pharyngeal obstruction in response to rostral fluid redistribution , which could predispose to pharyngeal collapse during sleep .


To investigate whether a virtual reality simulator ( LapSim ) and traditional box trainer are effective tools for the acquisition of basic laparoscopic skills , and whether the LapSim is superior to the box trainer in surgical education .


In a study at Ege University School of Medicine , Izmir , Turkey , between September 2008 and March 2013 , 40 first - and second-year residents were randomized to train via the LapSim or box trainer for 4 weeks , and 20 senior residents were allocated to a control group .


All 3 groups performed laparoscopic bilateral tubal ligation .


Video records of each operation were assessed via the general rating scale of the Objective Structured Assessment of Laparoscopic Salpingectomy and by operation time in seconds .


Compared with the control group , the LapSim and box trainer groups performed significantly better in total score ( P < 0.01 and P < 0.01 , respectively ) and time ( P = 0.03 and P = 0.01 , respectively ) .


There were no differences between the LapSim and box trainer groups .


Novice residents who trained on a LapSim or box trainer performed better live laparoscopies than residents who trained via standard clinical surgical education .


Training with a virtual reality simulator or box trainer should be considered before actual laparoscopic procedures are carried out .


Acupuncture has been used in China to treat tinnitus for a long time .


There is debate as to whether or not De Qi is a key factor in achieving the efficacy of acupuncture .


However , there is no sufficient evidence obtained from randomized controlled trials to confirm the role of De Qi in the treatment of acupuncture for tinnitus .


This study aims to identify the effect of De Qi for patients who receive acupuncture to alleviate tinnitus by a prospective , double-blind , randomized , sham-controlled trial .


This study compares two acupuncture groups ( with or without manipulation ) in 292 patients with a history of subjective tinnitus .


The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine .


In the study , the patients will be randomly assigned into two groups according to a computer-generated randomization list and assessed prior to treatment .


Then , they will receive 5 daily sessions of 30 minutes each time for 4 consecutive weeks and undergo a 12-week follow-up phase .


The administration of acupuncture follows the guidelines for clinical research on acupuncture ( WHO Regional Publication , Western Pacific Series Number 15 , 1995 ) , and is performed double-blind by physicians well-trained in acupuncture .


The measures of outcome include the subjective symptoms scores and quantitative sensations of De Qi evaluated by Visual Analog Scales ( VAS ) and the Chinese version of the ` modified ' Massachusetts General Hospital Acupuncture Sensation Scale ( C-MMASS ) .


Furthermore , adverse events are recorded and analyzed .


If any subjects are withdrawn from the trial , intention-to-treat analysis ( ITT ) and per-protocol ( PP ) analysis will be performed .


The key features of this trial include the randomization procedures , large sample and the standardized protocol to evaluate De Qi qualitatively and quantitatively in the treatment of acupuncture for tinnitus .


The trial will be the first study with a high evidence level in China to assess the efficacy of De Qi in the treatment of tinnitus in a randomized , double-blind , sham-controlled manner .


Chinese Clinical Trial Registry : ChiCTR-TRC-14004720 ( 6 May 2014 ) .


To evaluate the protective effects of oral administration of D-methionine tablets on noise-induced hearing impairment .


Two hundred and three volunteers were recruited and randomly divided into two groups : experimental group ( n = 113 ) and control group ( n = 90 ) .


The subjects received oral administration of D-methionine tablets in the experimental group and placebo in the control group before noise exposure .


Routine audiometric evaluation and ABR testing were performed and recorded before and after noise exposure .


The statistical analysis was carried out with SPSS 11.0 .


There were no differences in auditory threshold and I-V interpeak latency pre-noise exposure ( P > 0.05 ) , however , there were statistically significant differences between two groups 1 d , 7 d after noise exposure ( P < 0.01 and P < 0.05 ) .


In-respective-group , there were statistically significant differences between before and 1 d after noise exposure ( P < 0.05 and P < 0.01 ) , however , no difference was noted between before and 7 d after noise exposure in the experimental group ( P > 0.05 ) .


The protective effects of D-methionine tablets were prominent on the noise-induced hearing impairment .


Further studies regarding the optimal time of D-methionine administration will be recommended in the future .


Non-extensive superficial partial thickness burns constitute a major proportion of burns .


Conventional treatment involves regular changing of absorptive dressings including the application of a topical antimicrobial , commonly silver sulfadiazine .


A systematic review has found insufficient evidence to support or refute such antimicrobial prophylaxis .


Another review compared silver sulfadiazine dressings with other occlusive and non-antimicrobial dressings and found insufficient evidence to guide practice .


Other research has suggested that dressings with petrolatum gel are as effective as silver sulfadiazine .


Single-center , randomized , controlled parallel group trial comparing conventional silver sulfadiazine dressings with treatment with petrolatum gel alone .


Consenting adults 18-45 years old with superficial partial thickness burns10 % total body surface area seen within 24h of the injury were randomized to daily dressing either with petrolatum gel without top dressings or conventional silver sulfadiazine treatment with gauze dressings .


Primary outcomes were blinded assessment of time to complete re-epithelialization , wound infection or allergic contact dermatitis .


Secondary outcomes included assessment of ease , time and pain of dressing changes .


26 patients were randomized to petrolatum and 24 to silver sulfadiazine dressings .


Follow up data available for 19 in each group .


Mean time to re-epithelialization was 6.2 days ( SD 2.8 ) in the petrolatum group and 7.8 days ( SD 2.1 ) in the silver sulfadiazine group ( p = 0.050 ) .


No wound infection or dermatitis was observed in either group .


Scores for adherence to wound , ease of dressing removal and time required to change dressings were significantly better in the petrolatum treatment arm ( p < 0.01 ) .


Petrolatum gel without top dressings may be at least as effective as silver sulfadiazine gauze dressings with regard to time to re-epithelialization , and incidence of infection and allergic contact dermatitis .


Petrolatum gel appears to be an effective , affordable and widely available alternative in the treatment of minor superficial partial thickness burns in adults .


Studies have demonstrated that both pain and opioids have actions on the central nervous system that may interfere with cognitive function , but their effects have mainly been analysed separately and not as an integrated process .


The objective of this study is to test two hypotheses : ( 1 ) the analgesic effect of opioids improves cognitive function by decreasing pain , and ( 2 ) pain antagonizes cognitive effects of opioids .


Randomized , placebo-controlled , crossover study .


Three experiments were conducted with 22 healthy males .


Sustained attention , memory and motor function/attention/mental flexibility were evaluated by continuous reaction time ( CRT ) , verbal fluency test ( VFT ) and trail making test-B ( TMT-B ) , respectively .


In the 1st experiment , the cognitive effects of experimental tonic pain of mild and moderate intensities produced by a computer-controlled pneumatic tourniquet cuff were assessed ; in the 2nd , the effects of saline solution and remifentanil were assessed in the absence of pain ; and in the 3rd experiment , the cognitive effects of moderate pain intensity relieved by remifentanil infusion were assessed followed by increasing pain to moderate intensity during a constant remifentanil infusion .


The first two experiments demonstrated that pain and remifentanil impaired CRT .


In the 3rd experiment , remifentanil infusion relieving pain significantly impaired CRT and further deterioration was noted following increasing pain intensity .


Pain and remifentanil seemed to have additive deleterious cognitive effects .


This study represents an initial step to enhance our basic understanding of some of the cognitive effects following a painful stimulus and an opioid infusion separately and combined in a sequence comparable to clinical settings .


We sought to determine the feasibility of conducting percutaneous coronary intervention ( PCI ) in high-risk acute coronary syndrome ( ACS ) patients utilising the REG1 system consisting of pegnivacogin , an aptameric factor IXa inhibitor , and its controlling agent anivamersen .


In RADAR , ACS patients were randomised to pegnivacogin 1 mg/kg with 25 % , 50 % , 75 % , or 100 % anivamersen reversal or unfractionated heparin .


Of the 640 patients randomised , 388 ( 61 % ) underwent PCI .


Major modified ACUITY 30-day bleeding rates were 18 % ( 25 % reversal ) , 12 % ( 50 % reversal ) , 9 % ( 75 % reversal ) , and 7 % ( 100 % reversal ) , compared with 11 % with heparin .


The corresponding total bleeding rates were 68 % , 39 % , 35 % , 34 % , and 38 % ( heparin ) .


Ischaemic events were less frequent in those receiving pegnivacogin versus heparin ( 4.4 % vs. 7.3 % , p = 0.3 ) .


Thirty-day urgent TVR ( 1.1 % vs. 0.9 % , p = 1.0 ) , myocardial infarction ( 4.0 % vs. 6.4 % , p = 0.3 ) , and angiographic complication ( 11.2 % and 10.8 % , p = 0.9 ) rates were similar with pegnivacogin and heparin .


There were no incidences of clot formation on guidewires or catheters .


High-level factor IXa inhibition in ACS patients undergoing PCI , with at least 50 % reversal , has a favourable bleeding profile and appears effective at suppressing ischaemic events and thrombotic complications .


Larger phase trials in PCI are warranted .


ClinicalTrials.gov NCT00932100 .


Female pattern hair loss is a frequent and distressing condition .


To evaluate vs. control , the effects on hair loss of a 6-month supplementation with specific omega 3 & 6 and antioxidants .


One hundred and twenty healthy female subjects participated in this 6-month , randomized , comparative study .


The primary endpoint was the change in hair density evaluated on standardized photographs .


Secondary endpoints included changes in telogen hair percentage and diameter distribution of anagen hair ( > 40m vs. 40m ) measured by trichogram .


Overall changes in hair density and diameter were also measured by trichometer and by subjects ' self-assessment .


After 6 months of treatment , photograph assessment demonstrated a superior improvement in the supplemented group ( P < 0.001 ) .


The telogen hair percentage was significantly ( P < 0.001 ) reduced in the supplemented group .


The proportion of nonvellus anagen hair ( > 40m ) increased compared to the control group .


The trichometer index increased in the supplemented group , while it decreased in the control group .


A large majority of supplemented subjects reported a reduction in hair loss ( 89.9 % of subjects at 6months ) , as well as an improvement in hair diameter ( 86.1 % ) and hair density ( 87.3 % ) .


A 6-month supplementation with omega 3 & 6 and antioxidants acts efficiently against hair loss in improving hair density and reducing the telogen percentage and the proportion of miniaturized anagen hair .


Objectively measured improvements were confirmed by the subjects ' perception of efficacy .


Sham-controlled low-frequency repetitive transcranial magnetic stimulation ( rTMS ) was used in patients with pharmacoresistant major depression as an added treatment along with partial sleep deprivation ( PSD ) .


In addition , the potential predictive role of brain-derived neurotrophic factor genetic polymorphism on treatment response was analyzed .


We recruited 19 female patients ( 48.3 8.6 years old ) with treatment-resistant unipolar major depression ( Hamilton Depression Rating Scale [ HDRS ] score 20 ) who were on a stable antidepressant treatment .


They received either 1-Hz rTMS or sham stimulation over the right dorsolateral prefrontal cortex ( intensity of 110 % of the threshold ; 3000 stimuli per protocol ; and 10 daily sessions ) .


Additionally , PSD was applied once per week during the treatment .


The patients were evaluated ( HDRS and Clinical Global Impression Scale ) by a blind rater at baseline ( B ) and after 2 and 3 weeks ( W2 and W3 ) of treatment for short-term outcome .


Long-term evaluations were performed after 12 ( W12 ) and 24 weeks ( W24 ) for patients who received active stimulation .


Eleven patients in the active group showed a significant HDRS score reduction from 30.09 3.53 ( B ) to 16.73 5.71 ( W3 ) compared to the lack of therapeutic response in the sham-treated patients .


The long-term follow-up for the active group included 64 % of the responders at W12 and 55 % at W24 .


Full remission ( HDRS 10 ) was achieved in 5 of 11 patients .


Four of these 5 patients with long-term sustained remission expressed the Val66Val genotype .


Our study suggests a clinically relevant response , persisting for up to 6 months , from 1-Hz rTMS over the right dorsolateral prefrontal cortex and PSD in patients with pharmacoresistant major depression .


The brain-derived neurotrophic factor Val66Val homozygous genotype may be related to a better treatment outcome .


Computer-assisted surgery plays an increasingly important role in mandibular reconstruction , ensuring the best possible masticatory function and aesthetic outcome .


Twenty patients were randomly assigned to computer-assisted or conventional mandibular reconstruction with vascularized iliac crest bone graft in a prospective study design.Virtual surgical planning was based on preoperative CT-data using specific surgical planning software .


A rapid prototyping guide transferred the virtual surgery plan to the operation site .


During surgery the transplant ischemic time , reconstruction time , time for shaping the transplant and amount of bone removed were measured .


Additionally , the difference in the intercondylar distance before and after surgery was calculated .


Computer-assisted surgery shortened the time of transplant ischemia ( P < 0.005 ) and defect reconstruction ( P < 0.001 ) compared to conventional surgery .


The time to saw and shape the transplant at the donor site was shorter using conventional surgery ( P < 0.005 ) ; therefore , the overall time for surgery did n't change ( P = 0.527 ) .


In the computer-assisted group , the amount of bone harvested equaled the defect size , whereas the transplant size in the conventional group exceeded the defect site by 16.85.6 mm ( P < 0.001 ) on average .


The intercondylar distance before compared to after surgery was less affected in the computer-assisted than in the conventional group ( P < 0.001 ) .


The presented study shows that computer-assisted surgery can help reduce the time for mandibular defect reconstruction and consequently the transplant ischemic time .


In the computer-assisted group , the iliac crest donor site defect was downsized and the postoperative condyle position was less altered , reducing possible risks of postoperative complications and donor site morbidity .


DRKS00005181 .


The objectives of this study were to assess the efficacy of lifestyle intervention on gestational weight gain in pregnant women with normal and above normal body mass index ( BMI ) in a randomized controlled trial .


A total of 116 pregnant women ( < 20 weeks of pregnancy ) without diabetes were enrolled and 113 pregnant women completed the program .


Participants were randomized into intervention and control groups .


Women in the intervention group received weekly trainer-led group exercise sessions , instructed home exercise for 3-5-times / week during 20-36 weeks of gestation , and dietary counseling twice during pregnancy .


Participants in the control group did not receive the intervention .


All participants completed a physical activity questionnaire and a 3-day food record at enrolment and 2 months after enrolment .


The participants in the intervention group with normal pre-pregnancy BMI ( 24.9 kg/M2 , n = 30 ) had lower gestational weight gain ( GWG ) , offspring birth weight and excessive gestational weight gain ( EGWG ) on pregnancy weight gain compared to the control group ( n = 27 , p < 0.05 ) .


Those weight related-changes were not detected between the intervention ( n = 27 ) and control group ( n = 29 ) in the above normal pre-pregnancy BMI participants .


Intervention reduced total calorie , total fat , saturated fat and cholesterol intake were detected in women with normal or above normal pre-pregnancy BMI compared to the control group ( p < 0.05 or 0.01 ) .


Increased physical activity and reduced carbohydrate intake were detected in women with normal ( p < 0.05 ) , but not above normal , pre-pregnancy BMI at 2 months after the onset of the intervention compared to the control group .


The results of the present study demonstrated that the lifestyle intervention program decreased EGWG , GWG , offspring birth weight in pregnant women with normal , but not above normal , pre-pregnancy BMI , which was associated with increased physical activity and decreased carbohydrate intake .


NCT00486629 .


CPX-351 is a liposome-encapsulated fixed-molar-ratio formulation of cytarabine and daunorubicin that exploits molar ratio-dependent drug-drug synergy to enhance antileukemic efficacy .


This phase II study randomized 125 patients 2:1 to CPX-351 or investigators ' choice of first salvage chemotherapy .


Patients with acute myeloid leukemia ( AML ) in first relapse after initial Complete Remission ( CR ) lasting 1 month were stratified per the European Prognostic Index ( EPI ) into favorable , intermediate , and poor-risk groups based on duration of first CR , cytogenetics , age , and transplant history .


Control salvage treatment was usually based on cytarabine and anthracycline , often with 1 or more additional agents .


Survival at 1 year was the primary efficacy end point .


Patient characteristics were well balanced between the 2 study arms .


Improvements in efficacy outcomes were observed following CPX-351 , but did not meet prospectively defined statistical criteria for 1-year survival improvement in the overall population .


Subset analyses of the EPI-defined poor-risk strata demonstrated higher response rates ( 39.3 % vs 27.6 % ) and improvements in event-free survival ( HR , 0.63 ; P = .08 ) and overall survival ( HR , 0.55 ; P = .02 ) .


Also , 60-day mortality was lower in the CPX-351 study arm for poor-risk patients ( 16.1 % vs 24.1 % ) .


Taken together , the data suggest possible improved outcomes in CPX-351-treated first relapse AML patients with EPI-defined poor-risk disease .


to compare the effects of pulsed electromagnetic field ( PEMF ) therapy and sham treatment on DOMS-related variables in elbow flexors at 24 , 48 and 72 h after delayed onset muscle soreness ( DOMS ) induction exercise .


randomized , double-blind , placebo-controlled study .


Yonsei University laboratory .


In total , 30 healthy male college students .


Muscle soreness , peak torque , median frequency ( MDF ) and electromechanical delay ( EMD ) during isometric contraction at 24 , 48 and 72 h after DOMS induction exercise .


Overall , the application of the PEMF was found to be effective in reducing the physiological deficits associated with DOMS , including improved recovery of perceived muscle soreness , MDF , and EMD during isometric contraction .


Our results did not show that PEMF treatment was mechanically more effective for isometric peak torque generation compared to the sham group .


this study indicates that PEMF may be useful as a modality to reduce DOMS symptoms .


However , further well-designed experiments are required to determine optimal treatment dosage and duration , and to investigate the physiological and clinical mechanisms of PEMF on DOMS .


Supervised exercise training ( SET ) is recommended for patients with intermittent claudication ( IC ) .


The optimal exercise programme has not been identified , and the potential adverse effects of exercise on these patients warrant consideration .


Calpain proteases have been linked with tissue atrophy following ischaemia-reperfusion injury .


High calpain activity may therefore cause muscle wasting in claudicants undergoing SET , and skeletal muscle mass ( SMM ) is integral to healthy ageing .


This study assesses the impact of ( 1 ) treadmill-based SET alone ; and ( 2 ) treadmill-based SET combined with resistance training on pain-free walking distance ( PFWD ) , SMM , and calpain activity .


Thirty-five patients with IC were randomised to 12 weeks of treadmill only SET ( group A ) , or combined treadmill and lower-limb resistance SET ( group B ) .


PFWD via a 6-minute walking test , SMM via dual energy X-ray absorptiometry , and calpain activity via biopsies of gastrocnemius muscles were analysed .


Intention-to-treat analyses revealed PFWD improved within group A ( 160 m to 204 m , p = .03 ) , but not group B ( 181 m to 188 m , p = .82 ) .


There was no between group difference ( p = .42 ) .


Calpain activity increased within group A ( 1.62 10 ( 5 ) fluorescent units [ FU ] to 2.21 10 ( 5 ) FU , p = .05 ) , but not group B.


There was no between group difference ( p = .09 ) .


SMM decreased within group A ( -250 g , p = .11 ) and increased in group B ( 210 g , p = .38 ) ( p = .10 between groups ) .


Similar trends were evident for per protocol analyses , but , additionally , change in SMM was significantly different between groups ( p = .04 ) .


Neither exercise regimen was superior in terms of walking performance .


Further work is required to investigate the impact of the calpain system on SMM in claudicants undertaking SET .


To observe the therapeutic effect and relevant mechanism of shuxuening Injection ( SI ) in treating patients with active ulcerative colitis ( UC ) .


Totally 91 patients with active UC were randomly assigned to 2 groups , 44 in the control group and 47 in the treatment group .


Patients in the control group received routine treatment , while patients in the treatment group additionally received intravenous injection of SI ( 15 mL ) , twice daily for 14 days in total .


Colonoscopy was performed before and after treatment .


The therapeutic effect was assessed by Mayo scoring system and the grading of activities evaluated by Baron endoscope .


Serum levels of IL-6 and TNF - were detected by ELISA .


The activity of SOD was detected by xanthine oxidase method .


The content of MDA was detected by thiobarbituricacid ( TBA ) .


Besides , 20 healthy subjects were recruited as the healthy control group .


Totally 82 patients completed the study ( 40 in the control group and 42 in the treatment group ) .


There was no statistical difference in serum levels of IL-6 , TNF - , SOD , MDA , the Mayo score and endoscope grading between the two groups before treatment ( P > 0.05 ) .


Compared with the healthy control group , serum levels of IL-6 , TNF - , MDA significantly increased ( P < 0.01 ) , and the serum SOD level decreased ( P < 0.05 ) in the treatment grup and the control group before treatment .


Compared with before treatment in the same group , serum levels of IL-6 , TNF - , MDA , the Mayo score and endoscope grading all decreased in the treatment group and the control group after treatment ( P < 0.01 , P < 0.05 ) .


Compared with the control group after treatment , serum levels of IL-6 , TNF - , MDA , the Mayo score and endoscope grading all decreased ( P < 0.01 , P < 0.05 ) , the serum SOD level increased ( P < 0.05 ) in the treatment group after treatment .


The serum SOD level was obviously negative correlated with serum levels of IL-6 , TNF-a , Mayo score , and endoscope score ( r = -0.621 , -0.638 , -0.509 , -0.787 , P < 0.01 ) .


The serum MDA level was obviously positive correlated with serum levels of IL-6 , TNF - , Mayo score , and endoscope score ( r = 0.711 , 0.882 , 0.525 , 0.639 , P < 0.01 ) .


SI could improve inflammatory injury and clinical symptoms of patients with active UC , and its mechanism might be associated with antioxidant and scavenging oxygen free radicals .


To explored the effect of sildenafil in treatment of pregnant women with pulmonary arterial hypertension .


From January 2012 to November 2013 , 64 pregnant women with pulmonary arterial hypertension ( PAH ) were randomly divided into group and control group .


16 cases with mild and 16 cases with moderate PAH .


To treatment with low-flow oxygen , low-salt diet therapy , cardiac , etc.sildenafil group : 15 cases were mild pulmonary hypertension , and 17 cases moderate PAH .


Treatment sildenafil 25 mg , tid in this study .


Then the variation of the blood oxygen saturation , pulmonary artery systolic pressure , hemodynamic parameters and pregnancy outcome , including delivery modes , neonatal weight , morbidity of mother and fetus were compared .


( 1 ) Cardiac function and pulmonary hypertension : control group : the proportion of cardiac functional class I-II reduced from 81 % ( 26/32 ) to 56 % ( 18/32 ) significantly after treatment ( P < 0.05 ) .


Sildenafil group : the proportion of cardiac functional class I-II increased from 75 % ( 24/32 ) to 84 % ( 27/32 ) significantly after treatment ( P < 0.05 ) .


Between two groups , the proportion of mild and moderate turning to server PAH patients were significant difference ( P < 0.05 ) .


( 2 ) The pregnancy outcome of two group : the premature birth rate , low birth weight rate and cesarean section rate of 9 % ( 3/32 ) , 9 % ( 3/32 ) and 69 % ( 22/32 ) in sildenafil group were significantly lower than 16 % ( 5/32 ) , 19 % ( 6/32 ) and 81 % ( 26/32 ) in control group ( P < 0.05 ) .


The rate of vaginal delivery , term pregnancy and neonatal weight of 31 % ( 10/32 ) , 91 % ( 29/32 ) and ( 3 214 306 ) g in sildenafil group were different with 19 % ( 6/32 ) , 84 % ( 27/32 ) and ( 3 004 458 ) g in control group ( P < 0.05 ) .


( 3 ) Hemodynamic parameters : in control group , arterial partial pressure of oxygen , oxygen saturation and left ventricular ejection fraction , pulmonary systolic pression were ( 80 5 ) % to ( 72 8 ) % , ( 87 8 ) to ( 83 9 ) mmHg ( 1 mmHg = 0.133 kPa ) , 0.77 0.24 to 0.70 0.38 and ( 63 9 ) to ( 69 12 ) mmHg before and after treatment , which showed remarkable decreased trends ( P < 0.05 ) .


The other parameter were not significantly different ( P > 0.05 ) .


In sildenafil group , arterial partial pressure of oxygen , oxygen saturation and left ventricular ejection fraction , pulmonary systolic pression showed increased trend before and after treatment , which were ( 80 9 ) % to ( 88 9 ) % , ( 84 3 ) to ( 89 7 ) mmHg , 0.70 0.32 to 0.79 0.27 ( P < 0.05 ) , in the mean time , pulmonary systolic pression showed decreased trend from ( 65 18 ) to ( 60 13 ) mmHg ( P < 0.05 ) .


The other parameter did not show significant different ( P > 0.05 ) .


Sildenafil treatment can significantly improve the clinical symptoms , cardiac function and hemodynamic parameters.It also could significantly improve pregnancy outcomes , reduce premature delivery , the incidence of low birth weight children , and cesarean section rate .


The effectiveness of exercise therapy in the treatment of osteoarthritis of the knee ( KOA ) is widely evidenced .


The current study aims to compare the effectiveness of massage therapy as a co-adjuvant treatment for KOA .


A blind , randomized controlled trial design was used .


Eighteen women were randomly allocated to two different groups .


Group A was treated with massage therapy and an exercise program , and Group B was treated with the exercise program alone .


The intervention lasted for 6 weeks .


Outcomes were assessed using a verbal analogue scale ( VAS ) , the WOMAC index , and the Get-Up and Go test .


Baseline , post-treatment , and 1 - and 3 - month follow-up data were collected .


Values were considered statistically significant at a p < 0.05 .


The Mann-Whitney U test was applied in order to find out the differences between groups , and to verify the existence of such differences , the Friedman Test for repeated measures complemented with multiple comparisons tests was carried out .


In both groups , significant differences were found in the three variables between the baseline measurement and three months after treatment , with the exception of the WOMAC variable in group B ( p = 0.064 ) No significant differences were found between both groups in the WOMAC index ( p = 0.508 ) and VAS ( p = 0.964 ) variables and the Get-Up and Go test ( p = 0.691 ) .


Combining exercise-based therapy with massage therapy may lead to clinical improvement in patients with KOA .


The use of massage therapy combined with exercise as a treatment for gonarthrosis does not seem to have any beneficial effects .


To explore the best therapy for infertility caused by polycystic ovary syndrome ( PCOS ) .


One hundred and twenty patients were randomized into three groups , a clomi-phene group ( group A ) , an acupuncture-moxibustion + Chinese medicine group ( group B ) and a clomiphene + acupuncture-moxibustion + Chinese medicine group ( group C ) , 40 cases in each one .


In the group A , since the 5th day of menstruation , clomiphene was prescribed for oral administration .


In the group B , on the 5th day of menstruation , warm needling therapy was applied at Zhongji ( CV 3 ) , Guanyuan ( CV 4 ) , Guilai ( ST 29 ) , etc. .


Additionally , the Chinese herbal medication for tonifying the kidney and activating blood circulation was provided .


In the group C , the therapy as the group B was combined on the basis of the treatment as the group A.


The treatment lasted continuously for 3 menstrual cycles .


The endometrial thickness , endometrial type and cervical mucus score on human chorionic gon adotropin ( HCG ) day , and ovulatory cycle rate , clinical pregnancy rate and abortion rate after treatment were observed in the patients of the three groups .


1 ) HCG day cervical mucus score , endometrial thickness and endometrial morphology ( A type rate ) : the results in the group C were better than those in the group A ( all P < 0.01 ) ; the results in the group B were better than those in the group A ( all P < 0.05 ) .


The difference in the endometrial thickness was not significant in comparison between the group C and the group B ( P > 0.05 ) .


The cervical mucus score and endometrial morphology ( A type rate ) in the group C were better than those in the group B ( both P < 0.05 ) .


2 ) The ovulatory cycle rates in the group A and group ( C were higher than that in the group B ( both P < 0.05 ) , the pregnancy rate in the group C was higher than that in the other groups ( both P < 0.05 ) , and the early abortion rate in the group C was lower than that in the group A and group B ( both P < 0.01 ) .


3 ) Follicle diameter from 18 mm to 20 mm and endometrial thickness : the differences were not significant between the normal pregnancy patients and the early abortion patients ( both P > 0.05 ) .


The endometrial morphology A type rate in the normal pregnancy patients was higher than that in the early abortion patients ( P < 0.05 ) .


The combined therapy of acupuncture , herbal medicine and clomiphene improves the pregnancy rate and reduces early abortion rate by effectively improving HCG day cervical mucus , endometrial thickness and morphology .


The efficacy is apparently superior to the simple medication with clomiphene and the combined application of acupuncture and herbal medicine .


To reduce the seroma formation following mastectomy and axillary dissection , many different techniques and drugs have been investigated .


The aim of this study is to evaluate the effects of oral - glucan on drain fluid and efficacy of daily drainage and drain removal day in mastectomy patients .


One hundred and thirty breast cancer patients of Ankara Oncology Training and Research Hospital were divided into 2 groups by consecutive randomization ( n = 65 each ) .


- glucan 10mg capsules were administered to Group 1 twice a day for 10days .


Group 2 took placebos in the same manner .


Age , menarche age , menopause , parity , history of oral contraceptives , comorbidities , postoperative daily drainage volumes and drain removal days were recorded and compared .


Seroma samples during the first and second day of drainage were taken for analysis of Interleukin-6 ( IL-6 ) and Tumor Necrosis Factor ( TNF - ) .


There was no difference between groups in terms of age , menarche age , menopause period , parity , oral contraceptive use and comorbidities .


Group 1 showed significantly lower daily drainage volumes between days 2 and 8 .


Mean drain removal day was 7.161.72 in Group 1 and 8.592.27 in Group 2 .


The difference was significant ( p < 0.001 ) .


TNF - and IL-6 levels on days 1 and 2 in Group 1 were significantly lower ( p < 0.001 ) .


In addition , - glucan significantly shortened the number of days required for the drain removal in patients who have comorbidities ( p = 0.018 ) .


The earliest removal was in patients without comorbidity and who received - glucan ( p = 0.002 ) .


- glucan decreased drain discharges after mastectomy .


The drains were removed earlier in - glucan administered patients .


Efavirenz and nevirapine failure is associated with a rapid selection of resistance-associated mutations ( RAMs ) , which may impact on etravirine or rilpivirine susceptibility .


However , RAMs for rilpivirine and etravirine can not be reported on previous resistance genotypes because these specific RAMs were not analyzed at that time .


Therefore , our objective was to determine , in virologically suppressed HIV-1-infected individuals , the presence of RAMs to rilpivirine , etravirine and the combination of tenofovir/emtricitabine/rilpivirine in HIV-1 DNA from individuals previously exposed to efavirenz and/or nevirapine .


The studied population included 169 treatment-experienced individuals enrolled in the ANRS 138-EASIER trial who previously failed on and/or were intolerant to efavirenz and/or nevirapine and who had plasma HIV-1 RNA < 400 copies/mL .


Resistance to rilpivirine , etravirine , tenofovir and emtricitabine by bulk sequencing was performed on extracted HIV-1 DNA from whole blood collected at the time of trial inclusion .


Reverse transcriptase gene amplification was successful in 128/169 ( 76 % ) individuals and 95 % of HIV-1 were infected with subtype B. Rilpivirine RAMs were detected in 41 ( 32 % ) individuals , with highest frequency for the mutations Y181C/I/V ( 18 % ) , K101E/P ( 7 % ) and E138A/G/K / Q/R/S ( 6 % ) and the association L100I + K103N/S ( 5 % ) .


Etravirine RAMs were detected in five ( 4 % ) individuals .


Resistance to emtricitabine , tenofovir and at least one drug included in the combination of tenofovir/emtricitabine/rilpivirine were detected in 72 ( 56 % ) , 12 ( 9 % ) and 88 ( 69 % ) , respectively .


In individuals with suppressed viraemia under antiretroviral therapy ( ART ) , but who had been previously exposed to an efavirenz and/or nevirapine-based regimen , rilpivirine RAMs are frequent and etravirine RAMs are rare .


This finding suggests that the switch to a rilpivirine-based regimen should not be recommended .


To evaluate the incremental prognostic value of the number and maximum volume of coronary artery calcifications over modified Agatston score strata , age , pack-years , and smoking status for predicting cardiovascular events .


A total of 3559 male current and former smokers received a CT examination for lung cancer screening .


Smoking characteristics , patient demographics , and physician-diagnosed cardiovascular events were collected .


Images were acquired without electrocardiography gating on 16-slice CT scanners .


The association between the presence of both fatal and nonfatal cardiovascular events and the predictors was quantified using Cox proportional hazard analysis .


Median follow-up period was 2.9 years .


Incident cardiovascular events occurred in 186 participants .


Adjusted hazard ratios for modified Agatston score strata of 1 to 10 , 11 to 100 , 101 to 400 , and > 400 were 3.39 ( 95 % confidence interval [ CI ] , 1.20-9 .59 ) , 6.52 ( 95 % CI , 2.73-15 .60 ) , 6.58 ( 95 % CI , 2.75-15 .78 ) , and 12.58 ( 95 % CI , 5.42-29 .16 ) , respectively .


Moreover , comparing the models with and without modified Agatston score strata to the model with age , pack-years , and smoking status yielded a significantly better net reclassification improvement ( NRI ; 27.3 % ; P < .0001 ) .


Adding the number of calcifications to the model with age , pack-years , smoking status , and modified Agatston score strata resulted in a slightly better NRI ( 1.68 % ; P = .0490 ) with a hazard ratio of 1.13 ( 95 % CI , 1.05-1 .21 ) per 10 calcifications .


The incremental prognostic information contained in the volume of the largest calcification was not statistically significant ( NRI , 0.14 % ; P = .3458 ) .


Cardiovascular event rate increased with higher numbers of calcified lesions .


The number but not maximum volume of calcifications has independent , although minimal , prognostic value over age , pack-years , smoking status , and modified Agatston score strata in our population .


The results of the CLOTS 3 trial showed that intermittent pneumatic compression ( IPC ) reduced the risk of deep vein thrombosis and improved survival in immobile patients with stroke .


IPC is now being widely used in stroke units .


Here we describe the disability , living circumstances , quality of life , and hospital costs of patients in CLOTS 3 .


In CLOTS 3 , a parallel group trial in 94 UK hospitals , immobile patients with stroke from days 0 to 3 of admission were assigned with a computer-generated allocation sequence in a 1:1 ratio to IPC or no IPC through a central randomisation system .


We followed up patients at about 6 months with postal or telephone questionnaire to assess the secondary endpoints : disability ( Oxford Handicap Scale [ OHS ] ) , living circumstances , health-related quality of life ( EQ5D-3L ) , and hospital costs ( based on use of IPC and length of hospital stay ) .


Patients and carers who completed the postal questionnaires were not masked to treatment allocation , but telephone follow-up in non-responders was masked .


All analyses were by intention to treat .


This trial is registered , number ISRCTN93529999 .


Between Dec 8 , 2008 , and Sept 6 , 2012 , we enrolled 2876 patients , with 1438 in each group .


Despite the previously reported reduction in the risk of proximal deep vein thrombosis at 30 days ( primary endpoint ) , there were no significant differences in disability ( OHS 0-2 vs 3-6 , adjusted odds ratio [ OR ] 098 , 95 % CI 080 to 119 , p = 083 ; adjusted ordinal analysis common OR 097 , 95 % CI 086 to 111 ) , living circumstances ( institutional care vs not ; adjusted OR 111 , 95 % CI 089 to 137 ; p = 0358 ) , or health-related quality of life ( median utility value 026 , IQR -007 to 066 with IPC , and 027 , -006 to 064 , with no IPC ; p = 0952 ) .


The estimated cost of IPC was 6410 per patient ( SD 283 ) .


The direct costs of preventing a deep vein thrombosis and death were 1282 ( 95 % CI 785 to 3077 ) and 2756 ( 1346 to not estimable ) , respectively , with IPC .


Hospital costs increased by 451 with IPC compared with no IPC because of a longer stay in hospital ( mean 445 days [ SD 376 ] vs 428 days [ 372 ] ; mean difference 18 days , 95 % CI -10 to 45 ) .


By 6 months , despite an increase in survival ( IPC 1525 days [ SD 606 ] vs no IPC 1481 days [ 643 ] ; mean difference 45 days , 95 % CI -02 to 91 ) , there was a non-significant increase in quality-adjusted survival associated with IPC ( IPC 276 days [ SD 406 ] vs no IPC 267 days [ 396 ] ; mean difference 09 days , 95 % CI -21 to 39 ) .


IPC is inexpensive , prevents deep vein thrombosis , improves survival but not functional outcomes , and does not lead to a significant gain in quality-adjusted survival .


When deciding whether to treat patients with IPC , clinicians need to take into account all these potential effects .


National Institute of Health Research Health Technology Assessment Programme , Chief Scientist Office of Scottish Government , and Covidien .


Psychogenic gait disorder , defined as loss of ability to walk without neurological aetiologies , has poor rehabilitation options that are well documented .


Left untreated these patients have substantial and long-lasting dysfunction .


The present study examined the effect of a 3-week inpatient rehabilitation programme compared with a waiting list control condition , and whether eventual gains were maintained at 1-month and 1-year follow-up .


A cross-over design evaluated the effect of treatment , and a carry-over effect was considered as a long-lasting treatment effect .


Treatment consisted of adapted physical activity within a cognitive behavioural framework , and focused on offering an alternative explanation of symptoms , positively reinforcing normal gait and not reinforcing dysfunction .


A total of 60 patients were recruited from neurological departments and were randomly assigned to immediate treatment ( intervention ) or treatment after 4 weeks ( controls ) .


Cross-over design revealed that the mean difference between treatment vs no treatment was 8.4 Functional Independence Measure units ( p < 0.001 , 95 % confidence interval 5.2-11 .7 ) , and 6.9 Functional Mobility Scale units ( p < 0.001 , 95 % confidence interval 5.5-8 .3 ) .


Patients significantly improved their ability to walk and their quality of life after inpatient rehabilitation compared with the untreated control group .


The improvements in gait were sustained at 1-month and 1-year follow-up .


Substantial and lasting improvement can be achieved by inpatient rehabilitation of patients with psychogenic gait , and the gains are maintained during follow-up .


Chronic lung allograft dysfunction ( CLAD ) , predominantly manifest as bronchiolitis obliterans syndrome ( BOS ) , is the primary cause of morbidity and death after lung transplantation .


We assessed the efficacy and safety of 2 de novo immunosuppression protocols to prevent BOS .


This was a multicenter , prospective , international , randomized ( 1:1 ) open-label superiority study of de novo enteric-coated mycophenolate sodium ( MPS ) vs delayed-onset everolimus ( RAD ) , both arms in combination with cyclosporine ( CsA ) monitored by 2-hour post-dose ( C2 ) levels , and corticosteroids .


Target C2 levels were lower in the RAD group because RAD is known to potentiate CsA nephrotoxicity .


Cytolytic induction therapy was not used .


Patients were stratified at entry for cystic fibrosis .


Confirmation of anastomotic healing was required for randomization .


Primary efficacy was freedom from BOS Grade 1 on intention-to-treat ( ITT ) analysis .


Secondary efficacy parameters were patient and graft survival and severity of rejection .


Treatment failure was defined by graft loss , patient death , drug cessation , or need for other therapy .


The 3-year freedom from BOS Grade 1 was 70 % for MPS ( n = 80 ) vs 71 % for RAD ( n = 84 ; p = 0.95 by log-rank ) in ITT but was lower in the RAD arm of the per-protocol population ( p = 0.03 ) .


The 3-year survival was 84 % ( MPS ) vs 76 % ( RAD ; p = 0.19 by log-rank ) .


Thirteen patients switched from MPS vs 31 from RAD ( p < 0.01 ) .


Days on MPS were greater than days on RAD ( p < 0.01 ) .


Rejection events proven by biopsy specimen were more common on MPS ( p = 0.02 ) , as were leucopenia ( p < 0.01 ) , diarrhea ( p < 0.01 ) , and cytomegalovirus infection ( p = 0.04 ) .


Venous thromboembolism was more frequent on RAD ( p = 0.02 ) .


Creatinine at 3 years was 160 112 mol/1iter in MPS patients vs 152 98 mol/1iter in RAD patients ( p = 0.67 ) .


This 3-year ITT analysis found no significant difference between arms but was underpowered to accept the null hypothesis that RAD and MPS have equivalent efficacy in preventing BOS or death after lung transplantation .