GI-education improves GI-concept knowledge and helps lower dietary glycaemic index among women with a history of GDM .


To determine whether single-dose tranexamic acid given intravenously immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and blood transfusions .


A randomized double-blind , placebo-controlled multicenter study .


Two university hospitals and two central hospitals in the southeast health region of Sweden .


One hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery between March @ and May @ who complied with inclusion/exclusion criteria were randomized ; @ were allocated to receive tranexamic acid and @ to receive placebo .


Analysis was performed according to intention-to-treat principles .


The volume of tranexamic acid ( @mg/kg body weight , @mg/mL tranexamic acid ) or the same volume of placebo ( @ % NaCl ) was added to a @-mL saline solution plastic bag .


The study medication was given immediately before the start of surgery .


Data were analyzed by means of non-parametric statistics and multivariate models adjusted for confounding factors .


Blood loss and red blood cell transfusions .


The total blood loss volume and transfusion rate were significantly lower in the tranexamic acid group compared with the placebo group .


Median total blood loss was @ and @mL , respectively ( p = @ ) .


Fifteen ( @ % ) and @ ( @ % ) , respectively received transfusions ( odds ratio @ ; upper @ % CI @ ; p = @ ) .


A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates significantly in advanced ovarian cancer surgery .


Tranexamic acid may be recommended as standard prophylactic treatment in advanced ovarian cancer surgery .


To determine the effectiveness of a physical activity intervention for smoking cessation during pregnancy .


Parallel group , randomised controlled , multicentre trial .


@ hospitals in England , April @ to January @ .


@ pregnant smokers , aged @-@ years and at @-@ weeks ' gestation , who smoked at least one cigarette daily and were prepared to quit smoking one week after enrollment were randomised ( @:@ ) ; @ were included in the intention to treat analyses , with @ assigned to the physical activity group .


Interventions began one week before a target quit date .


Participants were randomised to six weekly sessions of behavioural support for smoking cessation ( control ) or to this support plus @ sessions combining supervised treadmill exercise and physical activity consultations .


The primary outcome was continuous smoking abstinence from the target quit date until end of pregnancy , validated by exhaled carbon monoxide or salivary cotinine levels .


To assess adherence , levels of moderate-vigorous intensity physical activity were self reported and in a @ % ( n = @ ) random subsample of participants , physical activity was objectively measured by an accelerometer .


No significant difference was found in rates of smoking abstinence at end of pregnancy between the physical activity and control groups ( @ % v @ % ; odds ratio @ , @ % confidence interval @ to @ ) .


For the physical activity group compared with the control group , there was a @ % ( @ % confidence interval @ % to @ % ) , @ % ( @ % to @ % ) , and @ % ( @ % to @ % ) greater increase in self reported minutes carrying out physical activity per week from baseline to one week , four weeks , and six weeks post-quit day , respectively .


According to the accelerometer data there was no significant difference in physical activity levels between the groups .


Participants attended a median of four treatment sessions in the intervention group and three in the control group .


Adverse events and birth outcomes were similar between the two groups , except for significantly more caesarean births in the control group than in the physical activity group ( @ % v @ % , P = @ ) .


Adding a physical activity intervention to behavioural smoking cessation support for pregnant women did not increase cessation rates at end of pregnancy .


During pregnancy , physical activity is not recommended for smoking cessation but remains indicated for general health benefits .


Trial registration Current Controlled Trials ISRCTN@ .


Cisplatin and gemcitabine is the standard first-line chemotherapy regimen for patients with advanced biliary tract cancer ; expression of VEGF and its receptors is associated with adverse outcomes .


We aimed to assess the effect of the addition of cediranib ( an oral inhibitor of VEGF receptor @ , @ , and @ ) to cisplatin and gemcitabine on progression-free survival .


In this multicentre , placebo-controlled , randomised phase @ study , we recruited patients aged @ years or older with histologically confirmed or cytologically confirmed advanced biliary tract cancer from hepatobiliary oncology referral centres in the UK .


Patients were eligible if they had an ECOG performance status of @-@ and an estimated life expectancy of longer than @ months .


Patients were given first-line cisplatin and gemcitabine chemotherapy ( @ mg/m ( @ ) cisplatin and @ mg/m ( @ ) gemcitabine -LSB- on days @ and @ every @ days , for up to eight cycles -RSB- ) with either @ mg oral cediranib or placebo once a day until disease progression .


We randomly assigned patients ( @:@ ) with a minimisation algorithm , incorporating the stratification factors : extent of disease , primary disease site , previous treatment , ECOG performance status , and centre .


The primary endpoint was progression-free survival in the intention-to-treat population .


This study is registered with ClinicalTrials.gov , number NCT@ , and was closed on Sept @ , @ ; results of the final analysis for the primary endpoint are presented .


Between April @ , @ , and Sept @ , @ , we enrolled @ patients ( @ in each group ) .


With a median follow-up of @ months ( IQR @-@ ) , median progression-free survival was @ months ( @ % CI @-@ ) in the cediranib group and @ months ( @-@ ) in the placebo group ( HR @ , @ % CI @-@ , @ % CI @-@ ; p = @ ) .


Patients who received cediranib had more grade @-@ toxic effects than did patients who received placebo : hypertension ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; p = @ ) , diarrhoea ( eight -LSB- @ % -RSB- vs two -LSB- @ % -RSB- ; p = @ ) ; platelet count decreased ( ten -LSB- @ % -RSB- vs four -LSB- @ % -RSB- ; p = @ ) , white blood cell decreased ( @ -LSB- @ % -RSB- vs seven -LSB- @ % -RSB- ; p = @ ) and fatigue ( @ -LSB- @ % -RSB- vs seven -LSB- @ % -RSB- ; p = @ ) .


Cediranib did not improve the progression-free survival of patients with advanced biliary tract cancer in combination with cisplatin and gemcitabine , which remains the standard of care .


Although patients in the cediranib group had more adverse events , we recorded no unexpected toxic effects .


The role of VEGF inhibition in addition to chemotherapy for patients with advanced biliary tract cancer remains investigational .


In the United Kingdom , licensed nicotine-containing products can be recommended to reduce the harm associated with smoking .


Many smokers find currently available nicotine replacement products unsatisfactory .


The arterial and venous pharmacokinetics ( PK ) of nicotine delivered via a novel inhaler device were determined .


Results are reported for Parts A ( N = @ ) and C ( N = @ ) of a @-part ( A-D ) Phase I study .


Participants ( @-@ years , @ cigarettes/day , smoking within @ hr of waking , expired carbon monoxide > @ ppm on screening ) orally inhaled @ single doses of nicotine ( @ of @ dose levels -LSB- @ , @ , and @ mg -RSB- ) ( Part A ) and repeated hourly doses of @ mg nicotine for @ hr ( Part C ) , via the novel device .


Arterial and venous PK and tolerability were assessed .


In Part A , mean arterial plasma nicotine concentrations at @ min after the start of inhalation were @ , @ , and @ ng/mL for the @ , @ , and @ mg doses , respectively .


Mean maximum arterial plasma nicotine concentrations ( C ( max ) ) were @ , @ , and @ ng/mL and mean times to C ( max ) were @ , @ , and @ min after the start of inhalation for the @ , @ , and @ mg doses , respectively .


In Part C , the mean pre - and postdose venous plasma nicotine concentration increased steadily and fluctuated in the range @-@ mg/mL after @ hr .


The novel device was well tolerated ; most adverse events were mild .


The novel inhaler device delivers nicotine rapidly into the systemic circulation and offers a viable alternative to cigarettes for those finding it difficult to quit the behavioral and sensorial aspects of smoking .


The N-methyl-D-aspartate glutamate receptor antagonist ketamine , delivered via an intravenous route , has shown rapid antidepressant effects in patients with treatment-resistant depression .


The current study was designed to test the safety , tolerability , and efficacy of intranasal ketamine in patients with depression who had failed at least one prior antidepressant trial .


In a randomized , double-blind , crossover study , @ patients with major depression were randomly assigned , and @ completed @ treatment days with intranasal ketamine hydrochloride ( @ mg ) or saline solution .


The primary efficacy outcome measure was change in depression severity @ hours after ketamine or placebo , measured using the Montgomery-sberg Depression Rating Scale .


Secondary outcomes included persistence of benefit , changes in self-reports of depression , changes in anxiety , and proportion of responders .


Potential psychotomimetic , dissociative , hemodynamic , and general adverse effects associated with ketamine were also measured .


Patients showed significant improvement in depressive symptoms at @ hours after ketamine compared to placebo ( t = @ , p < @ ; estimated mean Montgomery-sberg Depression Rating Scale score difference of @ @ ; @ % confidence interval , @-@ @ ) .


Response criteria were met by @ of @ patients ( @ % ) @ hours after ketamine administration compared with @ of @ ( @ % ) after placebo ( p = @ ) .


Intranasal ketamine was well tolerated with minimal psychotomimetic or dissociative effects and was not associated with clinically significant changes in hemodynamic parameters .


This study provides the first controlled evidence for the rapid antidepressant effects of intranasal ketamine .


Treatment was associated with minimal adverse effects .


If replicated , these findings may lead to novel approaches to the pharmacologic treatment of patients with major depression .


High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes , including coronary heart disease , stroke , decompensated heart failure , chronic kidney disease , and decline in cognitive function .


Observational studies show a progressive increase in risk associated with blood pressure above @/@ mm Hg .


Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease .


However , the optimal systolic blood pressure to reduce blood pressure-related adverse outcomes is unclear , and the benefit of treating to a level of systolic blood pressure well below @ mm Hg has not been proven in a large , definitive clinical trial .


To describe the design considerations of the Systolic Blood Pressure Intervention Trial ( SPRINT ) and the baseline characteristics of trial participants .


The Systolic Blood Pressure Intervention Trial is a multicenter , randomized , controlled trial that compares two strategies for treating systolic blood pressure : one targets the standard target of < @ mm Hg , and the other targets a more intensive target of < @ mm Hg .


Enrollment focused on volunteers of age @ years ( no upper limit ) with an average baseline systolic blood pressure @ mm Hg and evidence of cardiovascular disease , chronic kidney disease , @-year Framingham cardiovascular disease risk score @ % , or age @ years .


The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups : participants with chronic kidney disease ( estimated glomerular filtration rate < @ mL/min/@ @ m ( @ ) ) , participants with a history of cardiovascular disease , and participants @ years of age or older .


The primary outcome is first the occurrence of a myocardial infarction ( MI ) , acute coronary syndrome , stroke , heart failure , or cardiovascular disease death .


Secondary outcomes include all-cause mortality , decline in kidney function or development of end-stage renal disease , incident dementia , decline in cognitive function , and small-vessel cerebral ischemic disease .


Between @ November @ and @ March @ , Systolic Blood Pressure Intervention Trial recruited and randomized @ people at @ clinics , including @ women , @ with chronic kidney disease , @ with a history of cardiovascular disease , @ minorities , and @ @ years of age .


Although the overall recruitment target was met , the numbers recruited in the high-risk subgroups were lower than planned .


The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants , including those with prior cardiovascular disease , chronic kidney disease , and those aged @ years .


To observe the clinical effect of Shen-reinforcing and menstrual cycle-regulating therapy ( SRMCRT ) combined with Western medicine ( WM ) in treating decline in ovarian reserve ( DOR ) .


Totally @ patients with DOR were assigned to the traditional Chinese medicine combined WM group ( abbreviated as IM group , @ cases ) , and the WM group ( @ cases ) according to random digit table method .


Patients in the WM group were treated with hormone replacement therapy , while those in the IM group additionally received SRMCRT .


The therapeutic course for all was @ consecutive months .


The therapeutic efficacy was compared between the two groups .


The serum levels of follicle stimulating hormone ( FSH ) , FSH/luteinizing hormone ( LH ) , and estradiol ( E@ ) , as well as the development of sinus follicles were compared between before and after treatment in the two groups .


The therapeutic effective rate was @ % in the IM group , higher than that of the WM group ( @ % , P < @ ) .


The serum levels of FSH , FSH/LH , and E@ decreased ( P < @ ) and the number of the sinus follicle increased ( P < @ ) in the two groups after treatment .


Besides , IM was superior in decreasing serum levels of FSH and FSH/LH , and increasing the number of the sinus follicle ( P < @ ) .


SRMCRT was an effective method for treating ROD .


IM was superior in decreasing serum levels of FSH and FSH/LH , and increasing the number of the sinus follicle .


Animal studies suggest that the renin-angiotensin-aldosterone system is involved in neurocognitive function and the response to antihypertensive therapy .


We investigated the impact of circulating aldosterone and renin activity on cognition and cerebral hemodynamics at baseline and after antihypertensive therapy for @ year .


Participants were older adults ( n = @ ; mean age = @ years ) enrolled in a clinical trial .


Routine antihypertensive medications were replaced with the study regimen to achieve a blood pressure < @/@ mm Hg .


Executive function , memory , cerebral hemodynamics ( blood flow velocity ) , CO@ vasoreactivity ( measured using transcranial Doppler ultrasonography ) , plasma renin activity , and aldosterone were measured at baseline and at @ and @ months after the initiation of treatment .


At baseline , higher levels of circulating aldosterone were associated with lower blood flow velocity ( = -@ ; P = @ ) , lower CO@ vasoreactivity ( = -@ ; P = @ ) , and decreased autoregulation abilities ( = -@ ; P = @ ) .


Those with higher levels of aldosterone at baseline demonstrated the greatest improvement in executive function ( P = @ for the aldosterone effect ) and in CO@ vasoreactivity ( P = @ for the aldosterone effect ) after @ months of lowering blood pressure ( < @/@ mm Hg ) .


Plasma renin activity was not associated with any of the measures .


Higher levels of aldosterone may be associated with decreased cerebrovascular function in hypertension .


Those with higher aldosterone levels may benefit the most from lowering blood pressure .


The role of aldosterone in brain health warrants further investigation in a larger trial .


To compare the difference in the clinical efficacy on cervical spondylosis between acupuncture at three lines of cervical Jiaji ( EX-B @ ) and oral administration of jingfukang granules .


Three hundred cases of cervical spondylosis were divided into an acupuncture group and a medication group , @ cases in each one .


In the acupuncture group , according to the different types of cervical spondylosis , acupuncture was applied at three lines of cervical Jiaji ( EX-B @ ) , once a day .


In the medication group , jingfukang granules were prescribed for oral administration , one bag each time , three times a day .


The treatment of ten days made one session in the two groups and two sessions were required totally .


Before and after two sessions of treatment , the clinical assessment scale for cervical spondylosis ( CASCS ) was adopted to evaluate the score of subjective symptoms , clinical physical signs and adaptability as well as the total score in the patients of the two groups and the efficacy was compared .


The patients ' symptoms and physical signs were alleviated , the adaptability was improved and the score of each item and the total score were increased in the two groups after treatment ( all P < @ ) .


The improvements in the acupuncture group were better than those in the medication group ( all P < @ ) .


The curative and markedly effective rate was @ % ( @/@ ) in the acupuncture group , better than @ % ( @/@ ) in the medication group ( P < @ ) .


Acupuncture at three lines of cervical Jiaji ( EX-B @ ) achieves the significant clinical efficacy on cervical spondylosis .


This therapy is superior to relieving symptoms and physical signs and recovering adaptability as compared with jingfukang granules .


The standard of care for operable , stage I , non-small-cell lung cancer ( NSCLC ) is lobectomy with mediastinal lymph node dissection or sampling .


Stereotactic ablative radiotherapy ( SABR ) for inoperable stage I NSCLC has shown promising results , but two independent , randomised , phase @ trials of SABR in patients with operable stage I NSCLC ( STARS and ROSEL ) closed early due to slow accrual .


We aimed to assess overall survival for SABR versus surgery by pooling data from these trials .


Eligible patients in the STARS and ROSEL studies were those with clinical T@-@a ( < @ cm ) , N@M@ , operable NSCLC .


Patients were randomly assigned in a @:@ ratio to SABR or lobectomy with mediastinal lymph node dissection or sampling .


We did a pooled analysis in the intention-to-treat population using overall survival as the primary endpoint .


Both trials are registered with ClinicalTrials.gov ( STARS : NCT@ ; ROSEL : NCT@ ) .


@ patients were enrolled and randomly assigned ( @ to SABR and @ to surgery ) .


Median follow-up was @ months ( IQR @-@ ) for the SABR group and @ months ( @-@ ) for the surgery group .


Six patients in the surgery group died compared with one patient in the SABR group .


Estimated overall survival at @ years was @ % ( @ % CI @-@ ) in the SABR group compared with @ % ( @-@ ) in the surgery group ( hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ -RSB- , log-rank p = @ ) .


Recurrence-free survival at @ years was @ % ( @ % CI @-@ ) in the SABR group and @ % ( @-@ ) in the surgery group ( HR @ -LSB- @ % CI @-@ -RSB- , log-rank p = @ ) .


In the surgery group , one patient had regional nodal recurrence and two had distant metastases ; in the SABR group , one patient had local recurrence , four had regional nodal recurrence , and one had distant metastases .


Three ( @ % ) patients in the SABR group had grade @ treatment-related adverse events ( three -LSB- @ % -RSB- chest wall pain , two -LSB- @ % -RSB- dyspnoea or cough , and one -LSB- @ % -RSB- fatigue and rib fracture ) .


No patients given SABR had grade @ events or treatment-related death .


In the surgery group , one ( @ % ) patient died of surgical complications and @ ( @ % ) patients had grade @-@ treatment-related adverse events .


Grade @ events occurring in more than one patient in the surgery group were dyspnoea ( four -LSB- @ % -RSB- patients ) , chest pain ( four -LSB- @ % -RSB- patients ) , and lung infections ( two -LSB- @ % -RSB- ) .


SABR could be an option for treating operable stage I NSCLC .


Because of the small patient sample size and short follow-up , additional randomised studies comparing SABR with surgery in operable patients are warranted .


Major depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society .


Although antidepressant treatment is the most common therapy provided in routine practice , there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants .


The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy ( CBT ) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care .


The current study is a @-week assessor-blinded randomised , parallel-groups superiority trial with @-month follow-up at an outpatient clinic as part of usual depression care .


Patients aged @-@years with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ( DSM-IV ) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care , will be randomly assigned to receive CBT plus treatment as usual , or treatment as usual alone .


The primary outcome is the change in clinician-rated @-item GRID-Hamilton Depression Rating Scale ( GRID-HAMD ) score at @weeks , and secondary outcomes include severity and change in scores of subjective depression symptoms , proportion of responders and remitters , safety and quality of life .


The primary population will be the intention-to-treat patients .


The enigmatic etiology of neurodegenerative diseases poses a challenge for the development of novel and efficient drugs .


The objective of the present study was to evaluate the efficacy of a polyherbal ( test ) formulation on cognitive functions , inflammatory markers and oxidative stress in healthy elderly as well as senile dementia of Alzheimer 's type ( SDAT ) patients .


A randomized double-blind placebo - and active-controlled clinical trial was performed in healthy elderly subjects and SDAT patients with an age range of @-@ years .


The polyherbal test formulation along with a placebo was given to healthy elderly subjects while the SDAT patients received either the test formulation containing extracts of Bacopa monnieri ( whole plant ) , Hippophae rhamnoides ( leaves and fruits ) and Dioscorea bulbifera ( bulbils ) at a dose of @ mg or donepezil drug ( Aricept ) at a dose of @ mg , twice daily , for a period of @ months .


After every three months , cognitive functions were assessed by determining the mini mental state examination ( MMSE ) score , digital symbol substitution ( DSS ; subtest of the Wechsler Adult Intelligence Scale-Revised ) , immediate and delayed word recall ( digital memory apparatus-Medicaid systems , Chandigarh , India ) , attention span ( Attention Span Apparatus-Medicaid systems , Chandigarh , India ) , functional activity questionnaire ( FAQ ) and depression ( geriatric depression scale ) scores .


Further inflammatory markers and level of oxidative stress were analyzed using standard biochemical tests .


The trial was performed in @ healthy subjects and @ SDAT patients of whom @ healthy subjects and @ SDAT patients completed the study .


Administration of the test formulation for a period of @ months was effective in improving cognitive functions in the SDAT patients , when compared to the donepezil-treated group , as determined by the DSS ( @ @ vs @ @ , P = @ ) , word recall immediate ( @ @ vs @ @ , P < @ ) and attention span ( @ @ vs @ @ , P = @ ) scores .


A significant improvement in the FAQ ( @ @ vs @ @ , P < @ ) and depression ( @ @ vs @ @ , P < @ ) scores was also observed , whereas no significant differences were observed in the MMSE and word recall delayed scores .


The level of inflammation and oxidative stress was markedly reduced in the SDAT patients treated with the test formulation when compared to the donepezil-treated group indicating a likely mechanism of action of the test formulation ( homocysteine @ @ vs @ @ nmol/L , P < @ ; C-reactive protein -LSB- CRP -RSB- @ @ vs @ @ mg/L , P < @ ; tumour necrosis factor alpha -LSB- TNF - -RSB- @ @ vs @ @ pg/ml , P < @ ; superoxide dismutase -LSB- SOD -RSB- @ @ vs @ @ U/g Hb , P = @ ; glutathione peroxidase -LSB- GPx -RSB- @ @ vs @ @ U/g Hb , P < @ ; glutathione -LSB- GSH -RSB- @ @ vs @ @ U/g Hb , P < @ ; thiobarbituric acid reactive substances -LSB- TBARS -RSB- @ @ vs @ @ nmol/g Hb , P < @ ) .


Similarly , when healthy elderly subjects treated with the test formulation for @ months were compared to the placebo group , a significant ( P < @ ) improvement in cognitive measures ( MMSE , DSS , word recall delayed but not immediate , attention span , FAQ and depression scores ) and a reduction in inflammation ( reduction in homocysteine , CRP , IL-@ and TNF - levels ) and oxidative stress levels ( reduction in SOD , GPx and TBARS and increase in GSH ) was observed .


This indicated a protective effect of the test formulation in managing cognitive decline associated with the ageing process .


The results of this study demonstrate the therapeutic potential of this novel polyherbal formulation for the management and treatment of SDAT .


To determine the costs and cost-effectiveness of an early childhood home visiting program delivered to families in socio-economically disadvantaged areas of Sydney , Australia during @-@ .


Economic evaluation of a randomized controlled trial , the healthy beginnings ( HB ) trial , from the perspective of the health funder .


Intervention resources were determined from local health district records in @ $ AUD .


Health-care resource utilization was determined through patient-level data linkage .


The cost of HB intervention in the clinical trial over @ years was $ @ per child ( @ $ AUD ) .


The incremental cost-effectiveness ratio was $ @ per unit BMI avoided and $ @ per @ reduction in BMI z-score .


It was estimated that the program could be delivered in practice for $ @ per child ; with incremental cost-effectiveness ratios of $ @ per unit BMI avoided and $ @ per @ reduction in BMI z-score .


We present the first economic evaluation of an effective obesity prevention initiative in early childhood .


HB is a moderately priced intervention with demonstrated effectiveness that offers similar or better value for money than existing obesity prevention or treatment interventions targeted at older children .


To compare the Helicobacter pylori ( H. pylori ) eradication rate of clarithromycin-based triple therapy , metronidazole-based triple therapy , sequential therapy and concomitant therapy .


A total of @ patients infected with H. pylori were divided into @ groups and each group was treated with a different eradication therapy .


Clarithromycin-based triple therapy was applied to the first group -LSB- rabeprazole , amoxicillin and clarithromycin ( PAC ) group : proton pump inhibitor ( PPI ) , amoxicillin , clarithromycin -RSB- , whereas the second group was treated with metronidazole-based triple therapy -LSB- rabeprazole , amoxicillin and metronidazole ( PAM ) group : PPI , amoxicillin , metronidazole -RSB- .


The third group was treated with rabeprazole and amoxicillin , followed by rabeprazole , clarithromycin and metronidazole ( sequential group ) .


The final group was simultaneously treated with rabeprazole , amoxicillin clarithromycin and metronidazole ( concomitant therapy group ) .


In the case of a failure to eradicate H. pylori , second-line quadruple and third-line eradication therapies were administered .


The per protocol ( PP ) analysis was performed on @ , @ , @ and @ patients in the PAC , PAM , sequential and concomitant groups , respectively .


We excluded patients who did not receive a C ( @ ) - urea breath test ( @ , @ , @ and @ patients , respectively ) and patients with less than an @ % compliance level ( @ , @ , @ and @ patients , respectively ) .


The eradication rates were @ % ( @/@ ) in the PAC group , @ % ( @/@ ) in the PAM group , @ % ( @/@ ) in the sequential group and @ % ( @/@ ) in the concomitant group ( P = @ ) .


All @ patients who failed second-line therapy were treated with third-line eradication therapy .


Among these @ patients , @ infections were successfully eradicated with the third-line therapy .


Both PP and intention-to-treat analysis showed an eradication rate of @ % ( @/@ ) .


In the PAC group , @ of @ patients were successfully cured ( @/@ , @ % ) ; @ of @ patients in the PAM group ( @/@ , @ % ) and @ of @ patients in the sequential group ( @/@ , @ % ) were also cured .


In the concomitant group , all @ patients failed ( @/@ , @ % ) .


The eradication rate for the concomitant therapy was much higher than those of the standard triple therapy or sequential therapy ( ClinicalTrials.gov number NCT@ ) .


Ramucirumab is a human IgG@ monoclonal antibody that targets the extracellular domain of VEGFR-@ .


We aimed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as second-line treatment for patients with stage IV non-small-cell-lung cancer ( NSCLC ) after platinum-based therapy .


In this multicentre , double-blind , randomised phase @ trial ( REVEL ) , we enrolled patients with squamous or non-squamous NSCLC who had progressed during or after a first-line platinum-based chemotherapy regimen .


Patients were randomly allocated ( @:@ ) with a centralised , interactive voice-response system ( stratified by sex , region , performance status , and previous maintenance therapy -LSB- yes vs no -RSB- ) to receive docetaxel @ mg/m ( @ ) and either ramucirumab ( @ mg/kg ) or placebo on day @ of a @ day cycle until disease progression , unacceptable toxicity , withdrawal , or death .


The primary endpoint was overall survival in all patients allocated to treatment .


We assessed adverse events according to treatment received .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Dec @ , @ , and Jan @ , @ , we screened @ patients , of whom @ patients were randomly allocated to treatment .


Median overall survival was @ months ( IQR @-@ ) for @ patients allocated ramucirumab plus docetaxel and @ months ( @-@ ) for @ patients who received placebo plus docetaxel ( hazard ratio @ , @ % CI @-@ ; p = @ ) .


Median progression-free survival was @ months ( IQR @-@ ) for the ramucirumab group compared with @ months ( @-@ ) for the control group ( @ , @-@ ; p < @ ) .


We noted treatment-emergent adverse events in @ ( @ % ) of @ patients in the ramucirumab safety population and @ ( @ % ) of @ patients in the control safety population .


The most common grade @ or worse adverse events were neutropenia ( @ patients -LSB- @ % -RSB- in the ramucirumab group vs @ -LSB- @ % -RSB- in the control group ) , febrile neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , fatigue ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , leucopenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and hypertension ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


The numbers of deaths from adverse events ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) and grade @ or worse pulmonary haemorrhage ( eight -LSB- @ % -RSB- vs eight -LSB- @ % -RSB- ) did not differ between groups .


Toxicities were manageable with appropriate dose reductions and supportive care .


Ramucirumab plus docetaxel improves survival as second-line treatment of patients with stage IV NSCLC .


We compared the long-term success of desmopressin sublingual lyophilisate formulation and enuretic alarm therapy in children with primary monosymptomatic nocturnal enuresis , and determined predictive factors for treatment success .


A total of @ children with primary monosymptomatic nocturnal enuresis were randomized to receive treatment consisting of desmopressin or enuretic alarm for @ months .


Treatment compliance and response were reviewed monthly in each patient using a @-day bed-wetting diary .


Outcomes were assessed according to International Children 's Continence Society criteria , and success rates at @ and @ months were compared for desmopressin and enuretic alarm .


Additional intention to treat analyses were performed , considering cases with missing data as failures .


Possible demographic factors predicting success were investigated by logistic regression analysis .


Overall @ children ( @ % ) in the desmopressin group and @ ( @ % ) in the enuretic alarm group withdrew after randomization .


Based on patients who completed @ months of treatment , success ( more than @ % reduction in wet nights per month ) was achieved in @ % and @ % of children in the desmopressin and enuretic alarm groups , respectively .


At @ months @ % of those receiving desmopressin and @ % of those treated with enuretic alarm had success .


However , long-term success rate was significantly higher with desmopressin ( @ % vs @ % ) if intention to treat population was considered .


Multivariate analysis revealed treatment group , severity of enuresis and monthly income as independent predictors of cure at @ months .


In compliant patients desmopressin lyophilisate and enuretic alarm provided equivalent success at the end of treatment and after extended followup .


Alarm therapy had a high rate of early withdrawal from therapy and consequently lower rates of success on intention to treat analyses .


Severe enuresis ( more than @ wet nights weekly ) is an important predictive factor for cure after first-line treatment .


Following from previous research in which post-encoding suggestions of threat led to the development of a memory bias ( in the presumed absence of an attentional bias ; Senn & Radomsky , @ ) , we sought to examine whether the development of a similar threat-relevant memory bias could be fostered via a purely informational pathway .


A vignette about a classroom interaction was read aloud to ( n = @ ) undergraduate participants who then completed a post-encoding recall test .


Participants were told that the experimenter forgot to read the last sentence of the vignette , and were then randomly assigned either to the Threat condition , in which the additional statement indicated that a character in the vignette had a highly contagious flu , or to the No-Threat condition , in which the additional statement indicated that a character in the vignette had been accepted to graduate school .


A second recall test was then administered .


Participants in the Threat condition ( but not those in the No-Threat condition ) demonstrated aproportionate memory bias in favor of threatening information .


This bias was not evident at the initial recall test .


Time spent engaging in active recall was not assessed .


Also , although the study was designed to minimize demand characteristics , it is possible that these played a role .


An explicit memory bias for threat can be created through informational means alone , even when no threat was present at encoding .


Results are discussed in terms of pathways to fear and of cognitive approaches to understanding and treating anxiety disorders .


To evaluate the multi-function rapid allergic skin test instrument for application in drug allergy testing .


Three hundred patients were planned to be treated with cephalosporins Injection were divided randomly into @ groups , the new allergic skin test instrument group , normal allergic skin test instrument group , and traditional skin test group , the true positive rate and false positive rate were calculated .


Using multifunctional rapid allergy skin test was carried out on @ cases of volunteers preliminary clinical evaluation of traditional Chinese medicine injections skin test .


There were no significance difference between the new allergic skin test instrument group and control group in the true positive rate .


As compared with the control group , a significance difference was found between the new allergic skin test instrument group and control group in false positive rate respectively ( P < @ ) .


The multi-function rapid allergic skin test instrument is safe and easy to use , with a higher rate of accuracy and lower false positive rate .


Current medical knowledge has provided us with a wide range of possibilities of treating chronic wounds .


Over the recent decades , in particular , significant progress has been made in this field .


The authors present an overview of current knowledge of chronic wound healing , pointing out the surgeons role in the process of chronic wound management .


Using surgical therapy , we are able to heal a chronic wound in a shorter period of time , particularly if the treatment is accelerated by the application of platelet-rich plasma ( PRP ) as a source of growth factors .


The pilot randomized prospective study included four patients with chronic wounds of the lower leg after previous failure of conservative therapy who were indicated for skin transplantation .


Following previous vacuum-assisted closure therapy , the patients undergoing skin transplantation were prospectively randomized into two groups .


Autologous PRP was used in one of the groups and standard skin transplantation without PRP was performed in the other one .


In the PRP group , @ % of the wound areas were healed on the @th day after the operation .


In the other group , @ % of the areas were healed on the @th day following the operation .


In the PRP group , complete healing of the defect occurred in both patients at @ and @ days post-surgery .


In the second group , one patient completely healed within @ days ; the other one was not fully healed even at @ months post-surgery .


Most patient groups at great risk may benefit from the method using PRP , as well as patients with chronic wounds who have failed conventional methods available for both general and local therapy .


This fact has been confirmed by the authors initial experience presented.Key words : platelet-rich plasma ( PRP ) - platelets wound healing chronic wound .


To compare lag-screw sliding characteristics and fixation stability of two cephalomedullary nails ( CMN ) with different lag-screw designs ( solid and telescopic ) , we conducted a biomechanical study and an analysis of clinical results .


Six pairs of cadaver femurs with simulated intertrochanteric fractures were randomly assigned to one of two CMN fixations .


Femur constructs were statically then cyclically loaded on an MTS machine .


Lag-screw sliding and inferior and lateral femoral head displacements were measured , following which failure strength of the construct was determined .


Forty-five patients with intertrochanteric fractures treated with these CMN were identified .


Medical records and radiographs were reviewed and analyzed using Fisher 's exact test and Student 's t test to determine lag-screw sliding .


No difference was seen with cycling in inferior femoral head displacement between the two screw designs .


The solid screw had an average inferior head displacement of @ mm compared with @ mm for the telescoping screw ( p = @ ) .


The solid lag screws slid an average of @ mm lateral from the nail , whereas the telescoping screws slid an average of @ mm ( p = @ ) .


In our clinical review , the average lateral sliding of the telescoping screw was @ mm and of the solid screw was @ mm ( p < @ ) .


Despite differences in lateral sliding , there were no reoperations for prominent or painful hardware in either group .


Both designs are acceptable devices for stabilization of intertrochanteric fractures .


Clinical and biomechanical data demonstrate greater lateral sliding in the solid lag-screw group , making for greater potential for lateral-sided hip pain in CMNs with solid lag screws as opposed to telescoping lag screws .


Neonatal diagnoses are often used as surrogate endpoints for longer-term outcomes .


We sought to characterize the correlation between neonatal diagnoses and early childhood neurodevelopment .


We conducted secondary analysis of a multicenter randomized controlled trial of antenatal magnesium sulfate vs placebo administered to women at imminent risk for delivery < @ weeks to prevent death and cerebral palsy in their offspring .


Singletons and twins delivering @-@ @ weeks who survived to hospital discharge and had @-year-old outcome data were included .


Those surviving to age @ years were assessed by trained physicians and the Bayley II Scales of Infant Development Mental Development and Psychomotor Development Indices .


Neonatal diagnoses at the time of each baby 's initial hospital discharge were examined singly and in combination to determine those most predictive of childhood neurodevelopmental impairment , defined as a childhood diagnosis of moderate/severe cerebral palsy and/or Bayley scores > @ SD below the mean .


Data were analyzed by multiple regression models and area under receiver operating characteristic curves .


A total of @ children met criteria .


Children were delivered at a mean of @ weeks ' gestation .


In all , @ ( @ % ) had neurodevelopmental impairment .


In models controlling for gestational age at delivery , maternal education , maternal race , tobacco/alcohol/drug use during pregnancy , randomization to magnesium , fetal sex , and chorioamnionitis , individual neonatal morbidities were moderately predictive of childhood neurodevelopmental impairment ( best model area under receiver operating characteristic curve , @ ; @ % confidence interval , @-@ @ ) .


Combinations of @ , @ , and @ morbidities did not improve the prediction of neurodevelopmental impairment .


Approximately @ in @ previously preterm children had neurodevelopmental impairment at age @ years .


Prediction of childhood outcomes from neonatal diagnoses remains imperfect .


This @-week , multicenter , double-blind , randomized , placebo-controlled study ( NCT@ ) compared efficacy and safety of certolizumab pegol ( CZP ) in combination with methotrexate ( MTX ) vs placebo plus MTX in Japanese rheumatoid arthritis ( RA ) patients with inadequate response to MTX .


In total , @ patients were randomized @:@:@:@ to subcutaneous CZP @ , @ , or @ mg ( induction dose : @ mg or @ mg CZP at Weeks @ , @ , and @ ) plus MTX or placebo plus MTX every @ weeks .


Primary endpoint was ACR@ response at Week @ .


ACR@ response rates were @ % , @ % , @ % , and @ % at Week @ , and @ % , @ % , @ % , and @ % at Week @ for CZP @ , @ , and @ mg , and placebo groups , respectively , with statistical significance between each CZP group and placebo .


Change in Total Sharp Score over @ weeks was significantly smaller in CZP @ and @ mg groups vs placebo .


Improvements in health-related quality of life ( HRQoL ) were observed in all three CZP groups vs placebo .


Incidence of adverse events was similar between CZP groups .


CZP plus MTX resulted in rapid , sustained reductions in RA signs and symptoms in Japanese patients with inadequate response to MTX , with significant inhibition of radiographic progression and improved HRQoL .


Growth hormone deficiency ( GHD ) is associated with reduced bone mineral content and increased risk of osteoporotic fractures .


Reduced peak bone mass might explain the low bone mineral density ( BMD ) among patients with childhood onset GHD ( CO-GHD ) whilst the cause of osteopenia in adult-onset GHD ( AO-GHD ) is not fully understood .


Prospective multicentric study to asses bone status in GHD adults after two years of recombinant growth hormone replacement treatment .


In @ GHD adults ( @ men ; @ yrs ) we have measured BMD and bone markers ( CTX , osteocalcin ) during two years of rhGH treatment ( at baseline , after @ and @ months , and after @ and @ years ) .


Patients were adequately substituted for GHD and other pituitary deficiencies .


We have observed an increase in BMD-lumbar spine : n = @ , @ @ g/cm@ , p < @ ; femoral neck n = @ ; @ @ ; p = @ ; BMD-whole body @ @ ; p = @ .


We have compared gender difference : BMD-L-spine by @ % in men ( n = @ ) and by @ % in women ( n = @ ) ( p = @ ) ; BMD-femoral neck increased by @ % in men and by about @ % in women ( p = @ ) .


In women , the initial decrease in BMD was recorded after @ months .


CO-GHD adults yielded a higher increase in BMD - L-spine ( @ % , p = @ ) .


A correlation exists between IGF-I levels and BMD in lumbar spine ( @st year : R = @ , p = @ ; @nd year : R = @ , p = @ ) and between IGF-I and osteocalcin ( @st year : R = @ ; p = @ ) .


Two-year therapy with recombinant human growth hormone improved bone status .


IGF-I appears to be a good indicator of rhGH effect on bone ( Tab .


@ , Fig. @ , Ref .


Text in PDF www.elis.sk .


Up to @ % of patients with treatment-resistant schizophrenia do not respond to clozapine .


Pharmacological augmentation to clozapine has been studied with unimpressive results .


The authors examined the use of ECT as an augmentation to clozapine for treatment-refractory schizophrenia .


In a randomized single-blind @-week study , patients with clozapine-resistant schizophrenia were assigned to treatment as usual ( clozapine group ) or a course of bilateral ECT plus clozapine ( ECT plus clozapine group ) .


Nonresponders from the clozapine group received an @-week open trial of ECT ( crossover phase ) .


ECT was performed three times per week for the first @ weeks and twice weekly for the last @ weeks .


Clozapine dosages remained constant .


Response was defined as @ % reduction in symptoms based on the psychotic symptom subscale of the Brief Psychiatric Rating Scale , a Clinical Global Impressions ( CGI ) - severity rating < @ , and a CGI-improvement rating @ .


The intent-to-treat sample included @ participants ( ECT plus clozapine group , N = @ ; clozapine group , N = @ ) .


All @ patients from the clozapine group received ECT in the crossover phase .


Fifty percent of the ECT plus clozapine patients met the response criterion .


None of the patients in the clozapine group met the criterion .


In the crossover phase , response was @ % .


There were no discernible differences between groups on global cognition .


Two patients required the postponement of an ECT session because of mild confusion .


The augmentation of clozapine with ECT is a safe and effective treatment option .


Further research is required to determine the persistence of the improvement and the potential need for maintenance treatments .


To evaluate the performance effect of short-term catheter-directed thrombolysis with different dosage of rt-PA allied with endovascular interventional therapy for patients with acute lower limb ischemia .


To separate @ consecutive patients suffered from acute lower limb ischemia into two groups at random , then adopt catheter-directed thrombolysis for each group of patients injected @ mg ( Group A ) or @ mg ( Group B ) rt-PA into the occlusive lesion correspondingly , and subsequently perform endovascular intervention on significant underlying lesions on the base of angiography results .


Adopt statistical methods to assess treatment effectiveness , rates of complication and amputation rates within @ days , @ months or @ months .


The statistic analysis was performed under SPSS @ format , and adopts t test and ( @ ) test .


There was no statistical difference on patient characteristics and lesions between both groups ( P > @ ) .


Procedural success rates as well clinical success rates were all @ % .


Not incur any diversity on thrombolysis effectiveness between both groups injected different dosage of rt-PA ( P > @ ) .


Not found major differences on ratios of PTA or implant stent between both groups ( P > @ ) .


During the follow-up period of @-day , @ - , @ - months , there were no statistical differences on the amputation-free survival rates and complication rates between both groups .


Whereas short-term catheter-directed thrombolysis combined with endovascular interventional therapy won good operation effectiveness on patients with acute lower limb ischemia , moreover the dosage of rt-PA did not impact on thrombolysis , it is worthy to be applied in the clinical practice .


The Prevencin con Dieta Mediterrnea ( PREDIMED ) trial showed that a Mediterranean diet ( MedDiet ) supplemented with either extra virgin olive oil or @ g/d of mixed nuts reduced incident cardiovascular events compared with a control ( low fat ) diet .


The mechanisms of cardiovascular protection afforded by MedDiets remain to be uncovered .


We assessed the effect of both supplemented MedDiets on internal carotid intima-media thickness ( ICA-IMT ) and plaque height , the ultrasound features that best predict future cardiovascular events , in subjects at high cardiovascular risk .


In a PREDIMED subcohort ( n = @ ) , plaque height and carotid IMT of @ prespecified segments ( ICA , bifurcation , and common ) were sonographically assessed at baseline and after intervention for a mean of @ years .


We evaluated @ subjects with complete data .


In a multivariate model , mean ICA-IMT progressed in the control diet group ( mean -LSB- @ % confidence interval -RSB- , @ mm -LSB- -@ to @ mm -RSB- ) , whereas it regressed in the MedDiet + nuts group ( -@ mm -LSB- -@ to -@ mm -RSB- ; P = @ versus control ) .


Similar results were observed for maximum ICA-IMT ( control , @ mm -LSB- @ to @ mm -RSB- ; MedDiet + nuts , -@ mm -LSB- -@ to @ mm -RSB- ; P = @ ) and maximum plaque height ( control , @ mm -LSB- @ to @ mm -RSB- ; MedDiet + nuts , -@ mm -LSB- -@ to @ mm -RSB- ; P = @ ) .


There were no changes in ICA-IMT or plaque after the MedDiet + extra virgin olive oil .


Compared with a control diet , consumption of a MedDiet supplemented with nuts is associated with delayed progression of ICA-IMT and plaque .


The results contribute mechanistic evidence for the reduction of cardiovascular events observed in the PREDIMED trial .


This study assessed the efficacy and safety of the once-daily glucagon-like peptide-@ receptor agonist , lixisenatide , in Asian patients with type @ diabetes mellitus inadequately controlled on metforminsulfonylurea .


In this @-week , double-blind , placebo-controlled , multinational study , patients were randomized to lixisenatide @ g once daily or placebo .


The primary endpoint was absolute change in glycated haemoglobin ( HbA@c ) from baseline to week @ .


A total of @ patients were randomized .


Lixisenatide significantly reduced HbA@c levels compared with placebo ( LS mean difference : -@ % , p = @ ) .


A significantly higher proportion of lixisenatide-treated patients achieved HbA@c targets of < @ % ( p = @ ) and @ % ( p = @ ) versus placebo .


Lixisenatide was associated with a statistically significant reduction in @-h postprandial plasma glucose after a standardized breakfast versus placebo ( LS mean difference : -@ mmol/L , p < @ ) and a significant reduction in fasting plasma glucose ( p = @ ) .


There was no difference in weight loss versus placebo , with a modest reduction in body weight reported for both groups ( lixisenatide : -@ kg , placebo : -@ kg ; p = @ ) .


The incidence of treatment-emergent adverse events ( TEAEs ) was @ % with lixisenatide versus @ % with placebo , with serious TEAEs reported in @ % versus @ % of patients , respectively .


The most common TEAE in the lixisenatide group was nausea ( @ % vs @ % with placebo ) .


The incidence of symptomatic hypoglycaemia was @ % with lixisenatide treatment and @ % with placebo ( p = @ ) , with no severe symptomatic hypoglycaemia events reported .


In Asian patients with type @ diabetes mellitus insufficiently controlled on metforminsulfonylurea , lixisenatide significantly improved glycaemic control and was well tolerated during the @-week study .


School absenteeism because of infections is one of the most important problems facing both public and private primary schools .


The aim of the study was to assess the impact of infections on school absenteeism and their reduction with a handwashing program using hand sanitizer .


The study was an @-month-long , randomized , controlled open study ( N = @,@ children , aged @-@ years old ) at @ state schools in Almeria ( Spain ) .


The experimental group ( EG ) washed their hands with soap and water , complemented with the use of hand sanitizer , and the control group ( CG ) followed the usual handwashing procedure .


The total number of episodes and days missed as well as those because of upper respiratory infections and gastrointestinal infections were compared in both groups with a Z-test .


The students were absent @,@ days in @,@ episodes .


The incidence of total absent episodes and percent of missed days , including those because of upper respiratory infections and gastrointestinal infections , were significantly lower in the EG than the CG ( P < @ ) , and this was maintained through the flu pandemic period .


School absenteeism because of infections in schools is reduced when a hand hygiene program utilizing sanitizing gels is properly carried out , especially during the flu season .


The purpose of the study was to measure contact lens lipid spoliation of silicone hydrogel PureVision ( balafilcon A ) and hydrogel Acuvue @ ( etafilcon A ) contact lenses worn for @ hours single use ( DD ) and @ days of extended wear ( EW ) .


Two similar study populations ( DD , n = @ ; EW , n = @ ) , were enrolled at four study sites .


In each population , a bilateral , randomized , crossover ( lens material ) , subject-masked experimental design was followed .


Worn contact lenses were analyzed for lipid uptake using high-performance liquid chromatography by two laboratories : Alcon Laboratories ( right lens total uptake ) and OTG Research & Consultancy ( left lens total uptake and individual lipid classes ) .


Lipid uptake was different for the two materials : total lipid ( p < @ ) , cholesterol esters ( p < @ ) , cholesterol ( p < @ EW only ) , and triglycerides/phospholipids ( p < @ ) were higher for balafilcon A , whereas fatty acid ( p < @ EW only ) was higher for etafilcon A.


The ratio of the extracted lipids was also different : higher percentages of triglycerides/phospholipids ( p < @ ) and cholesterol ( p < @ EW only ) for balafilcon A and higher percentages of fatty acids/di - and monoglycerides ( p < @ ) for etafilcon A.


Total lipid uptake was highly material dependent .


Both laboratories measured a greater uptake of lipids by the silicone hydrogel than the hydrogel material , a difference that was evident after only @ hours of DD .


Total lipid uptake was greater after @ days of EW compared with @ hours of DD .


Of interest for contact lens spoliation and its avoidance was the differential lipid uptake profile , indicating material selectivity .


Whereas greater differentiation between materials was possible after @ days of EW for each material , the lipid uptake profile was similar for DD and EW , indicating a greater material effect than a wear modality effect .


This study was done to investigate how nicardipine , remifentanil and dexmedetomidine affect the balance of the autonomic nervous system in patients receiving controlled hypotension under general anaesthesia by evaluating heart rate variability indices .


Sixty-two patients were randomly allocated to either the nicardipine-sevoflurane ( Group N , n = @ ) , remifentanil-sevoflurane ( Group R , n = @ ) or dexmedetomidine-sevoflurane ( Group D , n = @ ) group for controlled hypotension during orthognathic surgery .


Electrocardiogram data acquisition was done after vital sign stabilization following anaesthesia induction ( T@ ) and @min after controlled hypotension was induced ( T@ ) .


Total power and low frequency ( LF ) power was significantly decreased at T@ compared with T@ in all groups , while a decrease in high frequency ( HF ) power was only observed in Group N ( P < @ ) .


LF/HF ratios of Group R and D were significantly suppressed at T@ compared with T@ ( P = @ and P < @ , respectively ) , but was increased Group N ( P = @ ) .


The LF/HF ratio of Group N was significantly higher than Group R and D at T@ ( P < @ in both ) , with Group D showing a significantly lower LF/HF ratio compared with Group R ( P < @ ) .


Remifentanil and dexmedetomidine did not have sympathetic nervous system-stimulating effects during controlled hypotension , while remifentanil seemed to be superior in preserving the overall balance in autonomic nervous system activity .


Nicardipine was found to stimulate the sympathetic nervous system , which may be problematic in patients vulnerable to disturbances in the autonomic nervous system .


Vortioxetine ( Lu AA@ ) is an antidepressant with a mechanism of action thought to be related to a combination of @ pharmacologic actions : direct modulation of several receptors and inhibition of the serotonin transporter .


To evaluate the efficacy of vortioxetine @ and @ mg once daily in outpatients with major depressive disorder .


This @-week , multicenter , randomized , double-blind , placebo-controlled , parallel-group study was conducted from July @ to January @ among adults with a primary diagnosis of recurrent major depressive disorder ( DSM-IV-TR ) .


Eligible subjects were randomized in @:@:@ ratio to @ of @ treatment arms : vortioxetine @ mg , vortioxetine @ mg , or placebo once daily for @ weeks .


Subjects who completed the @-week trial entered a @-week blinded discontinuation period to assess potential discontinuation symptoms .


The primary endpoint was the least squares mean change in Montgomery-Asberg Depression Rating Scale ( MADRS ) total score from baseline .


Key secondary outcomes were analyzed in the following prespecified sequential order : MADRS response ( @ % decrease from baseline in total score ) , Clinical Global Impressions-Improvement score , change from baseline in MADRS total score in subjects with baseline Hamilton Anxiety Rating Scale score @ , MADRS remission ( total score @ ) , and change from baseline in Sheehan Disability Scale total score ( all at week @ ) .


A total of @ subjects were randomized to placebo ( n = @ ) , vortioxetine @ mg ( n = @ ) , and vortioxetine @ mg ( n = @ ) .


Mean ( SE ) reductions from baseline in MADRS total score ( week @ ) were -@ ( @ ) , -@ ( @ ) , and -@ ( @ ) for the placebo , vortioxetine @ mg ( P = @ vs placebo ) , and vortioxetine @ mg ( P = @ vs placebo ) groups .


MADRS response/remission was achieved in @ % / @ % , @ % / @ % , and @ % / @ % of subjects , respectively , in the @ groups .


Only MADRS response for vortioxetine @ mg significantly separated from placebo ( P = @ ) .


Treatment was well tolerated , with the most frequently reported adverse events consisting of nausea , headache , diarrhea , and dizziness .


Vortioxetine @ mg significantly reduced MADRS total score at @ weeks in this study population .


Overall , vortioxetine was well tolerated in this study .


Experimental evidence has indicated the benefits of simvastatin for the treatment of subarachnoid hemorrhage .


Two randomized placebo-controlled pilot trials that used the highest clinically approved dose of simvastatin ( @ mg daily ) gave positive results despite the fact that a lower dose of simvastatin ( @ mg daily ) did not improve clinical outcomes .


We hypothesized that a high dose of @ mg of simvastatin daily for @ weeks would reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with a lower dose ( @ mg of simvastatin daily ) and lead to improved clinical outcomes .


The study design was a randomized controlled double-blinded clinical trial .


Patients with aneurysmal subarachnoid hemorrhage ( presenting within @ hours of the ictus ) from @ neurosurgical centers were recruited for @ years .


The primary outcome measure was the presence of delayed ischemic deficits , and secondary outcome measures included a modified Rankin disability score at @ months and an analysis of cost-effectiveness .


No difference was observed between the groups treated with the higher dose or the lower dose of simvastatin in the incidence of delayed ischemic deficits ( @ % versus @ % ; odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) or in the rate of favorable outcomes ( modified Rankin Scale score , @-@ ) at @ months ( @ % versus @ % ; odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


High-dose simvastatin treatment should not be prescribed routinely for aneurysmal subarachnoid hemorrhage .


We examined the cost-effectiveness of an intervention to reduce coronary heart disease ( CHD ) risk and blood pressure in African Americans .


Stochastic cost-effectiveness analysis alongside a clinical trial , augmented by a Markov model of lifetime cost-effectiveness .


In @ urban academic primary care practices , we randomized African American patients with uncontrolled hypertension to a @-month intervention of office practice and peer coach behavioral support ( N = @ ) or informational brochures about CHD risk factors ( N = @ ) .


Costs were estimated from the perspective of the provider .


Outcomes included estimated CHD events avoided over @ months and reduction in systolic blood pressure ( SBP ) ( mm Hg ) .


Subgroup analysis was performed for compliers who received an `` effective '' dose of the peer coach and office staff visits .


Long-term cost-effectiveness was estimated by applying the clinical trial cost and effectiveness into a Markov model of CHD risk .


The average cost for the behavioral support intervention group was $ @ compared with $ @ for the brochure control group .


The incremental cost-effectiveness ratio ( ICER ) was $ @ per mm Hg reduction in SBP and $ @,@ per CHD event avoided in @ months .


Modeled over a @-year horizon , the intervention had an ICER only as high as $ @ per incremental quality-adjusted life-year .


A community-primary care practice behavioral intervention to reduce hypertension in African Americans with sustained uncontrolled hypertension does not appear to be cost-effective in the first @ months .


If intervention results are sustained over the long term , the program may be cost-effective over the patient 's lifetime .


Our primary objective was to determine the proportion of patients with atrial fibrillation ( AF ) eligible for enrollment in a randomized controlled trial for a novel oral anticoagulant , the ARISTOTLE trial .


A secondary objective was to describe the reasons for trial ineligibility .


We performed a cross-sectional study of an unselected population including @ patients in Skellefte , Sweden with at least one verified episode of AF on or before December @ , @ .


Patients were classified as suitable or unsuitable for anticoagulant treatment according to current guidelines .


The enrollment criteria from the ARISTOTLE trial were extracted from the original publication and applied to the population .


Among all patients with AF , @ were classified as suitable for anticoagulant treatment .


Of these , only @ patients ( @ % ) were eligible for participation in the ARISTOTLE trial .


Among the @ patients ineligible for participation , @ did not meet the ECG criteria , @ had psychosocial problems , and in addition , @ patients were excluded due to both of these criteria .


Our study shows that a majority of the patients in an unselected population with AF suitable for anticoagulant treatment were ineligible for participation in the ARISTOTLE trial .


The applicability of the ARISTOTLE trial is therefore unknown for a considerable proportion of patients with AF in real life .


The purpose of this study was to evaluate the safety and effectiveness of @-level total disc replacement ( TDR ) using a Mobi-C cervical artificial disc at @ months ' follow-up .


A prospective randomized , US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at @ centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement ( @ patients ) or the control treatment , anterior cervical discectomy and fusion ( ACDF ) ( @ patients ) .


Patients were followed up at regular intervals for @ years after surgery .


At @ months , both groups demonstrated improvement in clinical outcome measures and a comparable safety profile .


Data were available for @ TDR patients and @ ACDF patients in calculation of the primary endpoint .


TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline : Neck Disability Index scores , @-Item Short Form Health Survey Physical Component Summary scores , patient satisfaction , and overall success .


ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs .


Overall , TDR patients maintained segmental range of motion through @ months with no device failure .


Four-year results from this study continue to support TDR as a safe , effective , and statistically superior alternative to ACDF for the treatment of degenerative disc disease at @ contiguous cervical levels .


Clinical trial registration no. : NCT@ ( clinicaltrials.gov ) .


The objective of this study was to test the effect of a brief educational and counseling intervention on increasing the uptake of free testing for Chlamydia trachomatis ( chlamydia ) and Neisseria gonorrhea ( gonorrhea ) among young female emergency department ( ED ) patients .


Women are particularly vulnerable to more serious consequences of these infections due to asymptomatic presentation .


Increased testing is important to detect , treat , and halt the spread of these infections among asymptomatic women .


This was a randomized controlled trial .


Research assistants ( RAs ) approached female patients in two EDs .


Eligible patients were between @ and @ years of age , who reported having sex with males , but were not attending the ED for either treatment of sexually transmitted infection ( STI ) or testing for possible STI exposure .


Participants responded to survey questions about their lifetime and past @-month substance use , number of recent sexual partners , condom use , and perception of risks for chlamydia and gonorrhea infections .


Following the survey , the RAs randomized participants into study control or treatment arms .


Each treatment arm participant received a brief educational/counseling intervention from the RA .


The brief intervention focused on the woman 's personal risks for chlamydia and gonorrhea and condoms attitudes and usage .


As the primary outcome of this study , participants were offered free urine tests for chlamydia and gonorrhea infection postintervention or post-survey completion , depending on group assignment .


A total of @ women completed the baseline assessment and were offered chlamydia and gonorrhea testing .


The mean ( SD ) age was @ ( @ ) years , @ % were Hispanic , and @ % were Spanish-speaking only .


The brief intervention that was offered to increase these women 's awareness of their STI risk did not result in increased acceptance of testing ; @ % in the brief intervention group accepted testing ( @ % confidence interval -LSB- CI -RSB- = @ % to @ % ) versus @ % in the control group ( @ % CI = @ % to @ % ) .


In a multivariable logistic regression , only self-identifying as being Hispanic was associated with greater willingness to be tested .


Of the asymptomatic women tested ( n = @ ) , five tested positive for chlamydia .


This represents a positivity rate of @ % .


There were no positive test results for gonorrhea .


Women who reported high-risk factors for STI , such as younger age ( @ years ) , having sex in the past @ days without using condoms , identified substance use , or previous STI , were not more likely to accept the offer of chlamydia and gonorrhea testing .


The brief intervention used in this study did not increase the uptake of testing for chlamydia and gonorrhea infections in this sample , in comparison to receiving no intervention .


Although Hispanic women were more likely to accept chlamydia and gonorrhea testing , it is concerning that those women who report STI risk factors were not more likely to accept the offer of chlamydia and gonorrhea testing .


Future research should focus on the refinement of an intervention protocol to focus on prior STI and lack of condom use to increase the uptake of testing among this high-risk group .


Preclinical studies support the hypothesis that endogenous neuroactive steroids mediate some effects of alcohol .


The aim of this study was to examine the effect of dutasteride inhibition of @-reduced neuroactive steroid production on subjective responses to alcohol in adult men .


Using a within-subject factorial design , @ men completed four randomly ordered monthly sessions in which pretreatment with @ mg dutasteride or placebo was paired with a moderate dose of alcohol ( @ g/kg ) or placebo beverage .


The pharmacologic effect of dutasteride was measured by an assay of serum androstanediol glucuronide .


Self-reports of alcohol effects were obtained at @-min intervals following alcohol administration using the Biphasic Alcohol Effects Scale ( BAES ) and the Alcohol Sensation Scale ( SS ) .


We used linear mixed models to examine the effects of dutasteride and alcohol on BAES and SS responses and the interaction of dutasteride with the GABRA@ alcohol dependence-associated polymorphism rs@ .


We also examined whether exposure to dutasteride influenced drinking in the weeks following each laboratory session .


A single @-mg dose of dutasteride produced a @ % reduction in androstanediol glucuronide .


Dutasteride pretreatment reduced alcohol effects on the BAES sedation and SS anesthesia scales .


There was no interaction of dutasteride with rs@ .


Heavy drinkers had fewer heavy drinking days during the @ weeks following the dutasteride sessions and fewer total drinks in the first week after dutasteride .


These results provide evidence that neuroactive steroids mediate some of the sedative effects of alcohol in adult men and that dutasteride may reduce drinking , presumably through its effects on neuroactive steroid concentrations .


Tapentadol prolonged release ( PR ) is effective and well tolerated for chronic osteoarthritis , low back , and diabetic peripheral neuropathic pain .


To evaluate the efficacy and tolerability of tapentadol PR compared with placebo and morphine controlled release ( CR ) for managing moderate to severe chronic malignant tumor-related pain .


Randomized-withdrawal , parallel group , active - and placebo-controlled , double-blind phase @ study ( NCT@ ) .


Primary , secondary , and tertiary care settings in @ countries .


Eligible patients ( pain intensity @ -LSB- @-point numerical rating scale -RSB- on prior analgesics ) were randomized ( @:@ ) and titrated to their optimal dose of tapentadol PR ( @-@ mg bid ) or morphine sulfate CR ( @-@ mg bid ) over @ weeks .


Morphine sulfate immediate release @ mg was permitted as needed for rescue medication ( no maximum dose ) .


Patients who completed titration and , during the last @ days of titration , had mean pain intensity < @ ( based on twice-daily ratings ) and mean rescue medication use = @ mg/day continued into a @-week maintenance period ; patients who received morphine CR during titration continued taking morphine CR , and those who received tapentadol PR were re-randomized ( @:@ ) to tapentadol PR or placebo bid .


Response during maintenance ( primary efficacy endpoint ) was defined as having : ( @ ) completed the maintenance period , ( @ ) a mean pain intensity < @ during maintenance , and ( @ ) used an average of = @ mg/day of rescue medication during maintenance .


Response at the end of titration was defined similarly , with pain intensity and rescue medication averages based on the last @ days of titration .


Of @ patients screened , @ were randomized , treated during titration , and evaluable for safety ; @ were re-randomized , treated during maintenance , and evaluable for safety ; and @ were evaluable for efficacy .


The adjusted responder rate estimate during maintenance ( logistic regression adjusting for treatment group , pooled center , and pain intensity at start of maintenance ) was significantly higher with tapentadol PR ( @ % ) than with placebo ( @ % ; odds ratio ( OR ) , @ -LSB- @ % confidence interval ( CI ) , @ - @ -RSB- ; P = @ ) .


Based on responder rates at the end of titration , tapentadol PR ( @ % -LSB- @/@ -RSB- ) was non-inferior to morphine CR ( @ % -LSB- @/@ -RSB- ) .


The lower limit of the @ % CI for the between-groups difference ( -@ % ) was within the pre-specified @ % non-inferiority margin .


During titration , incidences of treatment-emergent adverse events ( TEAEs ) were @ % ( @/@ ) with tapentadol PR and @ % ( @/@ ) with morphine CR ; incidences of nausea , vomiting , and dry mouth were lower with tapentadol PR than with morphine CR .


During maintenance , incidences of TEAEs were @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) with placebo , tapentadol PR , and morphine CR , respectively .


Statistical comparisons between tapentadol PR and morphine CR were limited to descriptive statistics during the maintenance period because of the pre-selection of responders to tapentadol PR or morphine CR during titration .


Results obtained during maintenance indicate that tapentadol PR ( @-@ mg bid ) is effective compared with placebo for managing moderate to severe chronic malignant tumor-related pain .


Based on results obtained during titration , tapentadol PR provides comparable efficacy to that of morphine sulfate CR ( @-@ mg bid ) , but is associated with better gastrointestinal tolerability .


The aim of this study was to determine the effect of a single dose of @g of clonidine as an adjuvant to levobupivacaine ( Chirocaine ( ) ) in retrobulbar block on postoperative safety and analgesia .


This was a prospective , randomized , controlled , double-blind trial .


One hundred twenty patients with a rhegmatogenous retinal detachment scheduled to undergo external buckling surgery and cryocoagulation were asked to participate .


Participants were randomly assigned either to receive @-@mL Chirocaine ( @-@ @ mg ) or @-@mL Chirocaine and @mL clonidine ( @g ) before surgery .


Main outcome measures were postoperative pain , use of analgesics , blood pressure , and plasma clonidine concentration .


Nine nonrandomized patients consented to give blood samples for pharmacokinetic analysis .


There was no significant difference in pain score between both groups .


On average , the use of analgesic medication occurred later in the clonidine group ( P = @ ) , but there was no statistical difference in the first time that postoperative medication was taken ( P = @ ) .


Blood pressure was reduced by clonidine ( systolic : P = @ , diastolic : P = @ ) .


Clonidine levels could be demonstrated during the @-h postoperative period , with an average half-life of @h .


Administration of clonidine as an adjuvant to conventional retrobulbar block is safe , and delays the postoperative use of analgesics .


The reduction of postoperative pain and the time of first use of analgesic medication , however , were not significantly different between groups .


Further , pain scores in both study groups remained low .


Therefore , the beneficial effect of clonidine in conventional scleral buckle surgery appears to be limited .


Osteoporosis is a skeletal disorder characterized by impaired bone turnover and compromised bone strength , thereby predisposing to increased risk of fracture .


Preclinical research has shown that compounds produced by the olive tree ( Olea europaea ) , may protect from bone loss , by increasing osteoblast activity at the expense of adipocyte formation .


The aim of this exploratory study was to obtain a first insight on the effect of intake of an olive extract on bone turnover in postmenopausal women with decreased bone mass ( osteopenia ) .


For that , a double blind , placebo-controlled study was performed in which participants were randomly allocated to either treatment or placebo groups .


@ osteopenic patients , with a mean bone mineral density ( BMD ) T-score between -@ and -@ in the lumbar spine ( L@-L@ ) were included in the study .


PARTICIPANTS received for @ months daily either @ mg/day of olive extract and @ mg Ca ( treatment ) or @ mg Ca alone ( placebo ) .


Primary endpoints consisted of evaluation of bone turnover markers .


Secondary endpoints included BMD measurements and blood lipid profiles .


After @ months , the levels of the pro-osteoblastic marker osteocalcin were found to significantly increase in the treatment group as compared to placebo .


Simultaneously , BMD decreased in the placebo group , while remaining stable in the treatment group .


In addition , improved lipid profiles were observed , with significant decrease in total - and LDL-cholesterol in the treatment group .


This exploratory study supports preclinical observations and warrants further research by showing that a specific olive polyphenol extract ( Bonolive ) affects serum osteocalcin levels and may stabilize lumbar spine BMD .


Moreover , the improved blood lipid profiles suggest additional health benefits associated to the intake of the olive polyphenol extract .


Recruitment is a challenge in developing population-representative pregnancy and birth cohorts .


We developed a collaborative recruitment infrastructure ( CRI ) to recruit pregnant women for @ pregnancy cohorts using : faxes from obstetrical offices , in-clinic recruiters , university and funder-driven free-media events , paid-media , and attendance at relevant tradeshows .


Recruitment rates and demographic differences were compared between recruitment methods .


We received @ referrals over @ months .


Compared to fax , free-media referrals were @ times more likely to be recruited ( OR @ , @ % CI @ , @ : p < @ ) and paid-media referrals were @ times more likely to be recruited ( OR @ , @ % CI @ , @ : p < @ ) .


Among paid-media advertisements , free-to-read print ( e.g. Metro ) was the most effective ( OR @ , @ % CI @ , @ : p < @ ) .


Several demographic differences were identified between recruitment methods and against a reference population .


Between recruitment methods , media recruits had a similar proportion families with incomes $ @,@ ( paid-media : @ % ; free-media : @ % ) compared to fax recruits ( @ % ) , while in-clinic recruits were less likely to have family incomes $ @,@ ( @ % , p < @ ) .


Maternal recruits from fax and in-clinic were more likely to attend university ( Fax : @ % , in-clinic @ % ) versus the reference population ( @ % ; p < @ for both ) and both were less likely to smoke ( Fax : @ % , in-clinic @ % ) versus reference ( @ % ; p < @ for both ) .


However , while fax referrals were more likely to be Caucasian ( @ % versus reference @ % ; p < @ ) , in-clinic referrals were not significantly different ( @ % ; P > @ ) .


Recruitment methods result in different recruitment rates and participant demographics .


A variety of methods are required to recruit a generalizable sample .


Research on contingency management to treat excessive alcohol use is limited due to feasibility issues with monitoring adherence .


This study examined the effectiveness of using transdermal alcohol monitoring as a continuous measure of alcohol use to implement financial contingencies to reduce heavy drinking .


Twenty-six male and female drinkers ( from @ to @ years old ) were recruited from the community .


Participants were randomly assigned to one of the two treatment sequences .


Sequence @ received @ weeks of no financial contingency ( i.e. , $ @ ) drinking followed by @ weeks each of $ @ and then $ @ contingency management ; Sequence @ received @ weeks of $ @ contingency management followed by @ weeks each of no contingency ( i.e. , $ @ ) and then $ @ contingency management .


During the $ @ and $ @ contingency management conditions , participants were paid each week when the Secure Continuous Remote Alcohol Monitor ( SCRAM-II ) identified no heavy drinking days .


Participants in both contingency management conditions had fewer drinking episodes and reduced frequencies of heavy drinking compared to the $ @ condition .


Participants randomized to Sequence @ ( receiving $ @ contingency before the $ @ condition ) exhibited less frequent drinking and less heavy drinking in the $ @ condition compared to participants from Sequence @ .


Transdermal alcohol monitoring can be used to implement contingency management programs to reduce excessive alcohol consumption .


In the European HIT-SIOP PNET@ randomized controlled trial , children with standard risk medulloblastoma were allocated to hyperfractionated radiation therapy ( HFRT arm , including a partially focused boost ) or standard radiation therapy ( STRT arm ) , followed , in both arms , by maintenance chemotherapy .


Event-free survival was similar in both arms .


Previous work showed that the HFRT arm was associated with worse growth and better questionnaire-based executive function , especially in children < @years of age at diagnosis .


Therefore , the aim of this study was to compare performance-based cognitive outcomes between treatment arms .


Neuropsychological data were collected prospectively in @ patients .


Using the Wechsler Intelligence Scales , Kaufman Assessment Battery for Children , and Raven 's Progressive Matrices , we estimated full-scale intelligence quotient ( FSIQ ) and , when available , verbal IQ ( VIQ ) , performance IQ ( PIQ ) , working memory index ( WMI ) , and processing speed index ( PSI ) .


Among the @ participants ( HFRT arm n = @ , STRT arm n = @ , @ % males ) , mean ( SD ) ages at diagnosis and assessment respectively were @ ( @ ) years of age ( @ % < @years of age at diagnosis ) and @ ( @ ) years of age .


Mean ( SD ) FSIQ was @ ( @ ) , and mean intergroup difference was @ ( @ % confidence interval : -@ to @ , P = @ ) .


No significant differences were found in children > @years of age at diagnosis .


In children < @years of age at diagnosis , a marginally significant trend toward higher VIQ was found in those treated in the HFRT arm ; a similar trend was found for PSI but not for PIQ , WMI , or FSIQ ( mean intergroup differences were : @ for VIQ -LSB- @ % CI : @-@ @ ; P = @ -RSB- ; @ for PIQ -LSB- @ % CI : -@ to @ ; P > @ -RSB- ; @ for WMI -LSB- @ % CI : -@ to @ ; P > @ -RSB- ; @ for PSI -LSB- @ % CI : -@ to @ ; P = @ -RSB- ; and @ for FSIQ -LSB- @ % CI : -@ to @ ; P > @ -RSB- ) .


HFRT was associated with marginally higher VIQ in children < @years of age at diagnosis , consistent with a previous report using questionnaire-based data .


However , overall cognitive ability was not significantly different .


Compare the treatment outcome after scaling and root-planing using local anesthesia gel or injected local anesthesia .


Thirty-eight patients with periodontitis and good general health were included in a randomized , single-blind , split-mouth clinical trial .


Probing depths and clinical attachment levels were recorded at baseline and @weeks after treatment .


Performed treatment procedures were scaling and root planing using two types of local anesthesia for separate treatment appointments .


Anesthetics used were intra-pocket lidocaine and prilocaine gel ( @ % each ) and injected articaine ( @:@,@ adrenaline ) .


Type of anesthesia for first appointment was randomized and switched for second appointment .


Patients ' pain perception and anesthesia acceptance were recorded on questionnaires .


No influence of applied type of anesthesia could be detected for change of probing pocket depths and clinical attachment level ( p > @ ) .


These findings are valid even for deeper pockets .


Gel-group had significant higher intra-operative pain perception .


In retrospect @ % of patients favored gel .


Treatment outcome is not compromised by use of anesthesia gel in comparison to injected anesthesia .


The same beneficial results for probing pocket depths and clinical attachment gain could be detected .


The majority of patients prefer local anesthesia gel despite a slightly greater procedural discomfort .


To explore the clinical values of detecting drug related molecules excision repair cross complementing @ ( ERCC@ ) and top-isomerase I ( TOPO I ) in individualized therapies of metastatic colorectal cancer .


From June @ to December @ , @ patients at Huadong Hospital with metastatic colorectal cancer were randomly separated into @ groups after operation .


Each group had @ patients without difference in gender , age or TNM stage .


The expressions of ERCC@ and TOPO Iin cancer tissues were detected by immunohistochemical staining .


The testing group received individualized chemotherapies following the expression results while the control group had random chemotherapies .


The survival difference between two groups was analyzed by log-rank test and Kaplan-Meier analysis .


And curative effect was analyzed by ( @ ) or Fisher 's analysis .


The expressions of ERCC@ and TOPO I had no statistical significance between two groups ( both P > @ ) .


In the testing group , the median survival time was @ days and the beneficial ratio @ % ( @/@ ) versus @ days and @ % ( @/@ ) respectively in the control group .


The inter-group comparisons of survival ( P = @ ) and curative effect ( ( @ ) = @ , P > @ ) showed no statistical significance .


In the estimated drug tolerated group ( ERCC@ high expression or TOPO I low expression ) , the median survival time was @ days and the beneficial ratio @/@ versus @ days and @ % ( @/@ ) in the estimated drug sensitive group .


The inter-group comparisons of survival and curative effect ( both P < @ ) had statistical significance .


The median survival time and beneficial ratio significantly increased in estimated drug sensitive group than those in estimated drug tolerated group .


The expression of drug related molecule in colorectal cancer tissue is significantly associated with curative effect in patients .


Patients with down-regulated ERCC@ on Oxaliplatin or up-regulated TOPO Ion Irinotecan have longer survival and better curative effect .


And chemotherapies guided by drug related molecule detection may boost curative effects in metastatic colorectal cancer .


Biodegradable-polymer drug-eluting stents ( BP-DES ) were developed to be as effective as second-generation durable-polymer drug-eluting stents ( DP-DES ) and as safe > @ year as bare-metal stents ( BMS ) .


Thus , very late stent thrombosis ( VLST ) attributable to durable polymers should no longer appear .


To address these early and late aspects , @ patients presenting with acute or stable coronary disease needing stents @ mm in diameter between April @ and May @ were randomly assigned to biolimus-A@-eluting BP-DES , second-generation everolimus-eluting DP-DES , or thin-strut silicon-carbide-coated BMS in @ European centers .


All patients were treated with aspirin and risk-adjusted doses of prasugrel .


The primary end point was combined cardiac death , myocardial infarction , and clinically indicated target-vessel revascularization within @ years .


The combined secondary safety end point was a composite of VLST , myocardial infarction , and cardiac death .


The cumulative incidence of the primary end point was @ % with BP-DES , @ % with DP-DES , and @ % with BMS .


By intention-to-treat BP-DES were noninferior ( predefined margin , @ % ) compared with DP-DES ( absolute risk difference , @ % ; -@ % to @ % ; P for noninferiority @ ; per protocol P = @ ) and superior to BMS ( absolute risk difference , -@ ; -@ to -@ ; P = @ ) .


The @ stent groups did not differ in the combined safety end point , with no decrease in events > @ year , particularly VLST with BP-DES .


In large vessel stenting , BP-DES appeared barely noninferior compared with DP-DES and more effective than thin-strut BMS , but without evidence for better safety nor lower VLST rates > @ year .


Findings challenge the concept that durable polymers are key in VLST formation .


The World Health Organization recommends vitamin A supplementation ( VAS ) at routine vaccination contacts after @ months of age based on the assumption that it reduces mortality by @ % .


The policy has never been evaluated in randomized controlled trials for its effect on overall mortality .


We conducted a randomized double-blind trial to evaluate the effect of VAS with vaccines .


We randomized children aged @ to @ months @:@ to VAS ( @ IU if aged @-@ months , @ IU if aged @-@ months ) or placebo at vaccination contacts in Guinea-Bissau .


Mortality rates were compared in Cox proportional-hazards models overall , and by gender and vaccine .


Between August @ and November @ , @ children were enrolled .


Within @ months of follow-up @ nonaccident deaths occurred ( VAS : @ ; placebo : @ ) .


The mortality rate ratio ( MRR ) comparing VAS versus placebo recipients was @ ( @ % confidence interval @-@ @ ) and differed significantly between boys ( MRR @ -LSB- @-@ @ -RSB- ) and girls ( MRR @ -LSB- @-@ @ -RSB- ) ( P = @ for interaction between VAS and gender ) .


At enrollment , @ % ( @/@ ) received live measles vaccine , @ % ( @/@ ) received inactivated diphtheria-tetanus-pertussis-containing vaccines , and @ % ( @/@ ) received both live and inactivated vaccines .


The effect of VAS did not differ by vaccine group .


This is the first randomized controlled trial to assess the effect of the policy on overall mortality .


VAS had no overall effect , but the effect differed significantly by gender .


More trials to ensure an optimal evidence-based vitamin A policy are warranted .


Sedation-analgesia is recommended for comfortable colonoscopy procedures , which are invasive and can be painful .


This study aimed to compare the combinations of propofol-alfentanil and propofol-fentanyl for sedation-analgesia in elective colonoscopy patients .


This prospective and randomized study was planned in ASA I-II groups and included @ patients between the ages of @ and @ years .


Sedation-analgesia induction was performed as @ g.kg ( -@ ) fentanyl , @mg .


kg ( -@ ) propofol in the propofol-fentanyl group ( Group PF ) and @ g.kg ( -@ ) alfentanil , @mg .


kg ( -@ ) propofol in the propofol-alfentanil group ( Group PA ) .


Patients ' scores were limited to @-@ values on the Ramsey Sedation Scale ( RSS ) by @ mg.kg ( -@ ) bolus additional doses of propofol in sedation-analgesia maintenance .


We recorded demographical data , heart rate , mean arterial pressure ( MAP ) , oxygen saturation of hemoglobin ( SpO@ ) , RSS value , colonoscopy time , total dose of propofol , complications , recovery time , and discharge time , as well as colonoscopist and patient satisfaction scores .


MAP at the @ ( th ) minute in Group PA was significantly higher than in Group PF ( p = @ ) .


Group PA 's beginning mean heart rate was higher than the mean heart rate at subsequent readings ( p = @ , p = @ ) .


The mean total propofol dose of Group PA was significantly higher than the total dose of Group PF ( p = @ ) .


The mean recovery time of Group PA was significantly longer than that of Group PF ( p = @ ) .


Fentanyl provides better operative conditions and reduces the need for additional propofol doses .


These advantages cause a shorter recovery time .


Therefore , propofol-fentanyl is superior to the propofol-alfentanil for sedation-analgesia in colonoscopy .


To investigate the immediate effects of manipulation of bilateral sacroiliac joints ( SIJs ) on the plantar pressure distribution in asymptomatic participants in the standing position .


Randomized , controlled , double-blind clinical trial .


Sixty-two asymptomatic men and women ( mean age , @ years ) randomly assigned to @ groups .


The experimental group underwent mobilization without tension of the hips in the supine position and high-velocity , low-amplitude manipulation in the SIJs bilaterally .


The control group underwent only mobilization , without tension of the hips in supine position .


Pre - and postintervention outcomes measured by an assessor blinded to the treatment allocation of the participants included a baropodometric analysis performed by using a force platform .


Baseline between-group differences were examined with a Kolmogorov-Smirnov test .


A chi-square test was used for categorical data .


Analysis of covariance ( ANCOVA ) was used to assess differences between groups , with the preintervention value as covariant ( @ % confidence level ) .


At baseline , no variables significantly differed between groups .


Baropodometric analysis showed statistically significant differences in the location of the maximum pressure point in the experimental group ( p = @ ) .


Pre - and postintervention analysis with ANCOVA showed statistically significant differences between both groups in the left hindfoot load percentage ( interaction p = @ ; ANCOVA p = @ ) , right foot load percentage ( ANCOVA p = @ ) , and surface of the right forefoot ( interaction p = @ ) .


There was also a significant effect in the variables that analyze the entire foot ( left foot : surface -LSB- interaction p = @ -RSB- , percentage of load -LSB- ANCOVA p = @ -RSB- ) and between both groups ( right foot : weight -LSB- interaction p = @ ; ANCOVA p = @ -RSB- ) .


Sacroiliac joint manipulation applied bilaterally in asymptomatic persons resulted in immediate changes in load distribution on plantar support in the standing position .


Study limitations and suggestions for future studies are discussed .


New-onset diabetes after transplantation ( NODAT ) is a common complication after renal transplantation .


There are limited available oral drugs to treat hyperglycaemia in this population owing to reduced renal function , potential interactions with immunosuppressive drugs and adverse effects such as hypoglycaemic events that may increase the cardiovascular risk .


This study was initiated to investigate efficacy and safety of sitagliptin treatment that may represent a novel alternative in renal transplant recipients .


Nineteen long-term stable renal transplant recipients with NODAT were included in a controlled , cross-over study and randomized to first receive either sitagliptin @-@ mg/day or a sitagliptin-free period of @ weeks .


Median age ( interquartile range , IQR ) was @ ( @-@ ) years ( @ males/@ females ) , all studied @ ( @-@ ) year after transplantation .


The immunosuppressive regimen was a triple calcineurin inhibitor-based therapy .


Oral glucose tolerance test ( OGTT ) with insulin and C-peptide responses and laser Doppler ( LD ) flowmetry assessment of endothelial function were performed at baseline and after each treatment period .


Home measurements of plasma glucose were performed daily during the study .


The median ( IQR ) first - and second-phase insulin secretion responses increased significantly by @ % ( @-@ @ % , P = @ ) and @ % ( @-@ @ % , P = @ ) , respectively , following sitagliptin treatment as compared with no sitagliptin treatment .


Fasting and @-h plasma glucose concentrations fell significantly -LCB- @ mmol/L -LSB- @-@ @ mmol/L ( @ mg/dL ) , P = @ -RSB- and @ mmol/L -LSB- @-@ @ mmol/L ( @ mg/dL ) , P = @ -RSB- , respectively -RCB- , as did also home measurements of plasma glucose .


Endothelial function and plasma markers of cardiovascular risk were unaffected .


No serious adverse events were observed .


Two mild and asymptomatic hypoglycaemic episodes were observed in combination with glipizide .


Sitagliptin increases insulin secretion and reduces fasting and postprandial plasma glucose in renal transplant recipients with NODAT .


The short-term treatment was well tolerated , and sitagliptin seems safe in this population .


Sepsis , a leading cause of death in critically ill patients , is the result of complex interactions between the infecting microorganisms and the host responses that influence clinical outcomes .


We evaluated the prognostic value of presepsin ( sCD@-ST ) , a novel biomarker of bacterial infection , and compared it with procalcitonin ( PCT ) .


This is a retrospective , case-control study of a multicenter , randomized clinical trial enrolling patients with severe sepsis or septic shock in ICUs in Italy .


We selected @ survivors and @ non-survivors at ICU discharge , matched for age , sex and time from sepsis diagnosis to enrollment .


Plasma samples were collected @ , @ and @ days after enrollment to assay presepsin and PCT .


Outcome was assessed @ and @ days after enrollment .


Early presepsin ( day @ ) was higher in decedents ( @,@ pg/ml , median ( Q@ to Q@ ) , @,@ to @,@ pg/ml ) than in survivors ( @,@ pg/ml ( median , @ to @,@ ) ; P = @ ) , whereas PCT was not different ( @ g/L ( median @ to @ ) and @ g/L ( @ to @ ) ; P = @ ) .


The evolution of presepsin levels over time was significantly different in survivors compared to decedents ( P for time-survival interaction = @ ) , whereas PCT decreased similarly in the two groups ( P = @ ) .


Presepsin was the only variable independently associated with ICU and @-day mortality in Cox models adjusted for clinical characteristics .


It showed better prognostic accuracy than PCT in the range of Sequential Organ Failure Assessment score ( area under the curve ( AUC ) from @ to @ vs. AUC @ to @ ) .


In this multicenter clinical trial , we provide the first evidence that presepsin measurements may have useful prognostic information for patients with severe sepsis or septic shock .


These preliminary findings suggest that presepsin may be of clinical importance for early risk stratification .


To compare the efficacy of celecoxib for treatment of withdrawal headache vs prednisone in patients with medication overuse headache ( MOH ) .


In this prospective , double-blind , parallel-group clinical trial , @ consecutive subjects with MOH were randomized ( simple randomization using computer-generated numbers ) for treatment with either @mg/day celecoxib ( for the first @ days then decreased at a rate of @mg every @ days ) or prednisone @ mg/day orally ( for the first @ days then tapered off every @ days ) .