The median overall survival times were @ months for arm A ( @ % CI = @ months to unreached ) and @ months for arm B ( @ % CI = @-@ @ months ) .


The most common grade @/grade @ adverse events in both arms were myelosuppression and nausea .


Thromboembolism , acneiform rash , fatigue , pain , hypersensitivity reactions , elevated transaminases , hyponatremia , and hypomagnesemia were more common in arm B ; @ grade @ adverse events occurred in arm B.


The presence of primary disease significantly correlated with thromboembolism .


An increased soluble E-cadherin level after cycle @ correlated with a higher risk of death .


GC plus CTX was feasible but was associated with more adverse events and no improvements in outcomes .


Infections with soil-transmitted helminths ( Ascaris lumbricoides , hookworm , and Trichuris trichiura ) are widespread and often occur concomitantly .


These parasitic-worm infections are typically treated with albendazole or mebendazole , but both drugs show low efficacy against T. trichiura .


Albendazole is the drug of choice against hookworm .


In this double-blind trial conducted on Pemba Island , Tanzania , we randomly assigned children , @ to @ years of age , to receive one of four treatments : oxantel pamoate at a dose of @ mg per kilogram of body weight , plus @ mg of albendazole , administered on consecutive days ; oxantel pamoate at a single dose of @ mg per kilogram ; albendazole at a single dose of @ mg ; or mebendazole at a single dose of @ mg .


We assessed the efficacy and safety profile of oxantel pamoate-albendazole when used in the treatment of T. trichiura infection ( primary outcome ) and concomitant soil-transmitted helminth infection ( secondary outcome ) .


Efficacy was determined by means of assessment of the cure rate and egg-reduction rate .


Adverse events were assessed four times after treatment .


Complete data were available for @ children , of whom @ were infected with T. trichiura , @ with hookworm , and @ with A. lumbricoides .


The cure rate of T. trichiura infection was significantly higher with oxantel pamoate-albendazole than with mebendazole ( @ % vs. @ % , P = @ ) , as was the egg-reduction rate ( @ % -LSB- @ % confidence interval -LCB- CI -RCB- , @ to @ -RSB- vs. @ % -LSB- @ % CI , @ to @ -RSB- ) .


The cure rate with albendazole ( @ % ) and the egg-reduction rate with albendazole ( @ % ; @ % CI , @ to @ ) were significantly lower than the rates with mebendazole ( P = @ for the comparison of cure rates ) .


Oxantel pamoate had low efficacy against hookworm and A. lumbricoides .


Adverse events ( mainly mild ) were reported by @ % of all children .


Treatment with oxantel pamoate-albendazole resulted in higher cure and egg-reduction rates for T. trichiura infection than the rates with standard therapy .


( Funded by the Medicor Foundation and the Swiss National Science Foundation ; Current Controlled Trials number , ISRCTN@ . )


The aim of the current study was to analyze the type of variations in expression profiles of matrix metalloproteinase @ ( MMP@ ) , matrix metalloproteinase @ ( MMP@ ) , tissue inhibitor of metalloproteinase @ ( TIMP@ ) , and vascular endothelial growth factor A ( VEGFA ) before and after radiochemotherapy in patients with locally advanced FIGO stage Ib-IIb cervical cancer .


We analyzed the role of these biomarkers in monitoring response to treatment .


Serum from @ patients with cervical cancer treated within a phase III trial with either simultaneous radiochemotherapy ( S-RC ) with cisplatin , or systemic paclitaxel and carboplatin followed by percutaneous radiation ( PC-R ) was analyzed by ELISA .


Sera were obtained during surgery and after the end of adjuvant treatment .


The median age at time of diagnosis was @ years ( range = @-@ years ) .


The most common histological types were squamous cell ( @ % ) and adenocarcinoma ( @ % ) .


Thirty-five ( @ % ) patients underwent surgery followed by S-RC and @ ( @ % ) patients were treated with surgery followed by PC-R .


Five patients developed recurrence within six months after radiochemotherapy .


VEGFA levels were significantly higher before and after adjuvant treatment in patients who developed early recurrence ( p = @ ) .


An increase of more than @ pg/ml VEGFA and a decrease of more than @ % of the pre-therapeutic value of TIMP@ were significantly associated with a higher risk of early recurrence ( RR = @ , @ % CI = @-@ @ and RR = @ , @ % CI = @-@ @ , respectively ) .


TIMP@ expression and risk score for early relapse ( which is calculated using values of VEGFA and TIMP@ ) were independent prognostic factors for overall survival ( p = @ , HR = @ , @ % CI = @-@ @ and p = @ , HR = @ , @ % CI = @-@ @ , respectively ) .


Our results indicate a predictive value of VEGFA and TIMP@ in monitoring cervical cancer patients undergoing radiochemotherapy .


Lumbosacral radicular syndrome ( LRS ) is a self-limiting , benign , painful and impairing condition caused by lumbar disc herniation and inflammatory processes around the nerve root .


Segmental epidural steroid injections ( SESIs ) are helpful to reduce radicular pain on a short-term basis .


It is unknown whether SESIs are an effective addition to usual pain treatment of LRS in general practice .


In our study , we assessed the effectiveness of SESIs on pain and disability as an addition to usual care for acute LRS in general practice .


A pragmatic , single-blinded , randomized controlled trial in Dutch general practice was conducted .


Circumstances of daily practice were closely followed .


Care as usual ( CAU ) was compared to care as usual combined with an additional SESI in @ patients in the acute phase of LRS .


To detect a minimal clinically important difference of @ points on a numerical rating scale for back pain and a common within-group standard deviation of @ with a two-tailed alpha of @ and a power of @ , we needed @ subjects in each group .


Statistical analysis was carried out using mixed models .


A small significant effect in favour of the intervention , corrected for age , sex and baseline values , was found for back pain , impairment and Roland-Morris disability score .


The differences , though statistically significant , were too small to be considered clinically relevant .


Patients from the intervention group were significantly more satisfied with the received treatment than patients from the control group .


We found a small , statistically significant , but not clinically relevant positive effect of SESIs on back pain , impairment and disability in acute LRS .


We do not recommend implementing SESIs as an additional regular treatment option in general practice .


Antiretroviral preexposure prophylaxis ( PrEP ) , using tenofovir disoproxil fumarate ( TDF ) and combination emtricitabine/tenofovir disoproxil fumarate ( FTC+TDF ) , is efficacious for prevention of human immunodeficiency virus ( HIV ) acquisition .


PrEP could reduce periconception HIV risk , but the effect on pregnancy outcomes is not well defined .


To assess pregnancy incidence and outcomes among women using PrEP during the periconception period .


Randomized trial among @ HIV-serodiscordant heterosexual couples ( the Partners PrEP Study ) in which the female partner was HIV uninfected that demonstrated that PrEP was efficacious for HIV prevention , conducted between July @ and June @ at @ sites in Kenya and Uganda .


Daily oral TDF ( n = @ ) , combination FTC+TDF ( n = @ ) , or placebo ( n = @ ) through July @ , when PrEP demonstrated efficacy for HIV prevention .


Thereafter , participants continued receiving active PrEP without placebo .


Pregnancy testing occurred monthly and study medication was discontinued when pregnancy was detected .


Pregnancy incidence , birth outcomes ( live births , pregnancy loss , preterm birth , congenital anomalies ) , and infant growth .


A total of @ pregnancies occurred .


Pregnancy incidence was @ per @ person-years among women assigned placebo , @ among those assigned TDF ( incidence difference , @ ; @ % CI , -@ to @ -LSB- P = @ vs placebo -RSB- ) , and @ among those assigned FTC+TDF ( incidence difference , -@ ; @ % CI , -@ to @ -LSB- P = @ vs placebo -RSB- ) .


Before discontinuation of the placebo treatment group in July @ , the occurrence of pregnancy loss ( @ of @ pregnancies ) was @ % for women receiving FTC+TDF compared with @ % for those receiving placebo ( difference for FTC+TDF vs placebo , @ % ; @ % CI , -@ % to @ % ; P = @ ) and was @ % for those receiving TDF alone ( difference vs placebo , -@ % ; @ % CI , -@ % to @ % ; P = @ ) .


After July @ , the frequency of pregnancy loss ( @ of @ pregnancies ) was @ % for FTC+TDF and @ % for TDF alone ( difference , @ % ; @ % CI , -@ % to @ % ; P = @ ) .


Occurrence of preterm birth , congenital anomalies , and growth throughout the first year of life did not differ significantly for infants born to women who received PrEP vs placebo .


Among HIV-serodiscordant heterosexual African couples , differences in pregnancy incidence , birth outcomes , and infant growth were not statistically different for women receiving PrEP with TDF alone or combination FTC+TDF compared with placebo at conception .


Given that PrEP was discontinued when pregnancy was detected and that CIs for the birth outcomes were wide , definitive statements about the safety of PrEP in the periconception period can not be made .


These results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant .


Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments .


This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years .


Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract ( @ mg/day ) or placebo for @weeks .


Desire , arousal , lubrication , orgasm , satisfaction , and pain were measured at baseline and after @weeks after the end of the treatment by using the Female Sexual Function Index ( FSFI ) .


Two groups were compared by repeated measurement ANOVA test .


Thirty women in placebo group and thirty women in drug group completed the study .


At the end of the fourth week , patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI ( p < @ ) , desire ( p < @ ) , arousal ( p = @ ) , lubrication ( p < @ ) , satisfaction ( p < @ ) and pain ( p = @ ) domains of FSFI .


Frequency of side effects was similar between the two groups .


Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder .


Further investigation of Tribulus terrestris in women is warranted .


Patients who undergo cardiac catheterization or percutaneous coronary intervention ( PCI ) often have a poor understanding of their disease and of related therapeutic risks , benefits , and alternatives .


This pilot study was undertaken to compare the effectiveness of @ preprocedural educational approaches to enhance patients ' knowledge of standard consent elements .


Patients undergoing first-time elective , outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process ( group I ) or a web-based , audiovisual presentation ( group II ) .


Preconsent and postconsent questionnaires were administered to evaluate changes in patients ' self-reported understanding of standard consent elements .


One hundred and two patients enrolled at a single institution completed the pre - and postconsent surveys ( group I = @ ; group II = @ ) .


Changes in patient comprehension rates were similar between groups for risk and benefit consent elements , but group II had significantly greater improvement in the identification of treatment alternatives than group I ( p = @ ) .


Independent of intervention , correct identification of all risks and alternatives increased significantly after consent ( p < @ ) ; @ of @ queried risks were correctly identified by greater than @ % of respondents .


However , misperceptions of benefits persisted after consent ; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by @ % and @ % of respondents , respectively .


Although both scripted verbal and audiovisual informed consent improved patient comprehension , important patient misperceptions regarding PCI-related outcomes and alternatives persist , independent of informed consent approach , and considerable challenges still exist in educating patients about contemplated medical procedures .


Future research appears warranted to improve patient comprehension .


Epidemiological data on the prevalence of headache in nursing staff in Mainland China are lacking .


We therefore performed a study to assess the prevalence of headache , and factors associated with headaches , in nursing staff in three hospitals in North China .


Stratified random cluster sampling was used to select @ nurses from various departments in three hospitals .


A structured questionnaire was used to collect epidemiological data , headache characteristics and associated factors .


The response rate was @ % .


Among nursing staff , the @-year prevalence of primary headache disorders was @ % , of migraine @ % ( migraine with aura @ % , migraine without aura @ % ) , of tension-type headache ( TTH ) @ % , of chronic daily headache ( CDH ) @ % .


Multivariate analysis showed that seniority ( @ years ) was a risk factor for migraine ( OR @ ) , obesity ( BMI@ ) was a risk factor for TTH and CDH ( OR @ and @ ) , and age ( @ years ) was a risk factor for CDH ( OR @ ) .


Nurses working in internal medicine were more likely to suffer CDH than those in other departments .


Working a greater number of night shifts was also associated with increased prevalence of headache .


The prevalence of primary headache disorders in nurses is higher than that in the general population in China , and occupational factors may play an important role .


Therefore , the prevalence of headache in nurses should be a focus of attention , and coping strategies should be provided .


Such measures could contribute to improving patient care .


This open-label study evaluated the effects of fentanyl buccal tablet ( FBT ) on functioning and mood in cancer patients with breakthrough cancer pain ( BTcP ) .


Opioid-tolerant patients in seven European countries with up to four BTcP episodes/day received FBT doses ( @-@ g ) identified during open-label titration to treat up to eight BTcP episodes during an open-label treatment period .


In countries where FBT was not commercially available , patients could enter an open-label continuation phase .


Functionality and satisfaction assessments included change from baseline to the end of the treatment period in the modified Brief Pain Inventory ( BPI-@S ) seven-item interference subscale , patient 's global assessment of satisfaction and ease of use , and Patient 's Global Impression of Change ( PGIC ) .


Safety was also assessed .


Of @ randomized patients , @ completed the treatment period and @ entered the continuation phase .


Median background pain intensity was @ ( mild ) throughout the study .


After the treatment period , mean ( SD ) global modified BPI-@S score improved from @ ( @ ) at baseline to @ ( @ ) for a mean change of -@ ( @ % confidence interval CI -@ , -@ ; P < @ ) , and @ % of patients reported improvement in overall status ( PGIC ) compared with @ % who reported no change or worsening ( P < @ ) .


Treatment-related adverse events ( @ patients ) during the continuation phase were application site erythema ( @ % ) , application site swelling ( @ % ) , and vertigo ( @ % ) .


FBT may improve patient functioning , mood , and overall satisfaction in the management of BTcP .


Long-term data did not indicate new safety concerns with FBT doses up to @ g.


Enteral administration of immune-modulating nutrients ( eg , glutamine , omega-@ fatty acids , selenium , and antioxidants ) has been suggested to reduce infections and improve recovery from critical illness .


However , controversy exists on the use of immune-modulating enteral nutrition , reflected by lack of consensus in guidelines .


To determine whether high-protein enteral nutrition enriched with immune-modulating nutrients ( IMHP ) reduces the incidence of infections compared with standard high-protein enteral nutrition ( HP ) in mechanically ventilated critically ill patients .


The MetaPlus study , a randomized , double-blind , multicenter trial , was conducted from February @ through April @ including a @-month follow-up period in @ intensive care units ( ICUs ) in the Netherlands , Germany , France , and Belgium .


A total of @ adult patients who were expected to be ventilated for more than @ hours and to require enteral nutrition for more than @ hours were randomized to the IMHP ( n = @ ) or HP ( n = @ ) group and included in an intention-to-treat analysis , performed for the total population as well as predefined medical , surgical , and trauma subpopulations .


High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition , initiated within @ hours of ICU admission and continued during the ICU stay for a maximum of @ days .


The primary outcome measure was incidence of new infections according to the Centers for Disease Control and Prevention ( CDC ) definitions .


Secondary end points included mortality , Sequential Organ Failure Assessment ( SOFA ) scores , mechanical ventilation duration , ICU and hospital lengths of stay , and subtypes of infections according CDC definitions .


There were no statistically significant differences in incidence of new infections between the groups : @ % ( @ % CI , @ % -@ % ) in the IMHP group vs @ % ( @ % CI , @ % -@ % ) in the HP group ( P = @ ) .


No statistically significant differences were observed in other end points , except for a higher @-month mortality rate in the medical subgroup : @ % ( @ % CI , @ % -@ % ) in the IMHP group vs @ % ( @ % CI , @ % -@ % ) in the HP group ( P = @ ) , with a hazard ratio of @ ( @ % CI , @-@ @ ; P = @ ) for @-month mortality adjusted for age and Acute Physiology and Chronic Health Evaluation II score comparing the groups .


Among adult patients breathing with the aid of mechanical ventilation in the ICU , IMHP compared with HP did not improve infectious complications or other clinical end points and may be harmful as suggested by increased adjusted mortality at @ months .


These findings do not support the use of IMHP nutrients in these patients .


Although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data .


The purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture .


In four Dutch hospitals , children aged @ years with a both-bone forearm fracture were prospectively followed up consecutive children for @-@ months .


At the final follow-up , pronation/supination and angular malunion on radiographs were determined .


Between January @ and August @ , a total of @ children were prospectively followed up , of which @ children were included for analysis in this study .


The mean age of the children was @ ( @ ) years , of which @ % were male and @ % fractured their dominant arm .


The mean time to final examination was @ ( @ ) days .


Children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of @ had a @-@ % chance of developing a clinically relevant limitation ( i.e. , < @ of pronation and/or supination ) , while children with an angular malalignment of @ had a @ % chance .


Children with diaphyseal both-bone forearm fractures with @ of angular malalignment had a @ % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment .


Children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment .


A double-blind placebo-controlled study was conducted according to EMA guidelines , to evaluate safety , tolerability and short-term treatment effects of three updosing regimens of Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy .


Forty-eight patients were randomized to groups : A ( six weekly doses ) , B ( eight weekly doses ) or C ( eight doses , two clustered doses over @ weeks ) .


The most frequent adverse events were local reactions .


No serious adverse events were found .


Severe systemic reactions were reported more frequently in Group C. Decreased cutaneous responses and increased specific IgGs were shown in all active groups , even within the short-term .


Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy in depot presentation exhibited good safety and tolerability .


Group A seemed to show the best profile for further clinical development .


The treatment of symptomatic acromioclavicular joint ( ACJ ) injury in the rotator cuff ( RC ) tear has not been well clarified .


To compare the clinical results between patients who had distal clavicle resection ( DCR ) and those who did not during RC repair .


Randomized controlled trial ; Level of evidence , @ .


From August @ to December @ , a total of @ consecutive patients ( @ shoulders ) were included .


All patients had either a full-thickness or high-grade ( > @ % ) RC tear , ACJ tenderness , arthritic change visible on plain radiographs , and a positive ACJ lidocaine injection test the day before surgery .


Patients were randomized into @ groups : DCR and RC repair ( DCR+RCR group ) and RC repair only ( isolated RCR ) .


Evaluation was performed preoperatively , at @ months postoperatively , and at a final follow-up a minimum of @ months postoperatively using the American Shoulder and Elbow Surgeons ( ASES ) score , the Constant shoulder score , range of motion examination , and pain visual analog scale ( VAS ) .


After simple randomization , @ shoulders were allocated in the DCR+RCR group , and @ were placed in the isolated RCR group .


Five shoulders in the DCR+RCR group and @ in the isolated RCR group were excluded from analysis due to loss of follow-up .


Therefore , the evaluation was performed for @ shoulders in the DCR+RCR group and @ shoulders in the isolated RCR group .


The mean follow-up period was @ months in the DCR+RCR group and @ months in the isolated RCR group .


There were no differences in age , sex , symptom duration , RC tear size , or preoperative ASES , Constant , and VAS scores between the @ groups ( P > @ ) .


At final follow-up , the ASES , Constant , and VAS scores were significantly improved in both groups ( P < @ ) .


There were no differences in ASES , Constant , and VAS scores between the @ groups at final follow-up ( P > @ ) , and there was no difference in residual ACJ tenderness ( @ in the DCR+RCR group and @ in the isolated RCR group ) between the @ groups ( P = @ ) .


There was no difference in the clinical evaluations between the combined arthroscopic DCR and RCR group and the isolated RCR group at a minimum @-month follow-up .


Arthroscopic DCR should be carefully considered in patients who have symptomatic ACJ arthritis with RC tears .


Although catheter ablation is an effective rhythm control strategy for atrial fibrillation ( AF ) , empirically-based ablation has a substantial recurrence rate .


The purposes of this study were to develop a computational platform for patient-specific virtual AF ablation and to compare the anti-fibrillatory effects of @ different virtual ablation protocols with empirically chosen clinical ablations .


We included @ patients with AF ( @ % male , @ years old , @ % persistent AF -LSB- PeAF -RSB- ) who had undergone empirically-based catheter ablation : circumferential pulmonary vein isolation ( CPVI ) for paroxysmal AF ( PAF ) and additional posterior box lesion ( L@ ) and anterior line ( L@ ) for PeAF .


Using patient-specific three-dimensional left atrial ( LA ) geometry , we generated a finite element model and tested the AF termination rate after @ different virtual ablations : CPVI alone , CPVI+L @ , CPVI+L @,@ , CPVI with complex fractionated atrial electrogram ( CFAE ) ablation , and CFAE ablation alone .


Virtual CPVI+L @,@ ablation showed the highest AF termination rate in overall patients ( @ % ) and PeAF patients ( n = @ , @ % ) .


The virtual AF maintenance duration was shortest in the case of virtual CPVI+L @,@ ablation in overall patients ( @ vs. @ s , p = @ ) and in patients with PeAF ( @ vs. @ s , p = @ ) compared with other protocols .


Virtual AF ablation using personalized in-silico model of LA is feasible .


Virtual ablation with CPVI+L @,@ shows the highest antifibrillatory effect , concordant with the empirical ablation protocol in patients with PeAF .


To investigate the effectiveness of Lactobacillus reuteri DSM @ for the treatment of infantile colic in breastfed Canadian infants , compared with placebo .


A randomized , double-blind , placebo-controlled trial was conducted involving @ infants with colic , according to modified Wessel criteria , who were assigned at random to receive L reuteri DSM @ ( @ ( @ ) colony-forming units ) ( n = @ ) or placebo ( n = @ ) for @ days .


Daily crying and fussing times were recorded in a structured diary , and maternal questionnaires were completed to monitor changes in infant colic symptoms and adverse events .


Total average crying and fussing times throughout the study ( from baseline to day @ ) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group ( @ @ minutes -LSB- @ @ hours -RSB- vs @ @ minutes -LSB- @ @ hours -RSB- ; P = @ ) ( relative risk , @ ; @ % CI , @-@ @ ) .


Infants given L reuteri DSM @ showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo ( median , @ minutes/day -LSB- IQR , @ minutes/day -RSB- vs @ minutes/day -LSB- IQR , @ minutes/day -RSB- ; P = @ ) .


On day @ , a significantly higher proportion of infants in the L reuteri DSM @ group responded to treatment with a @ % crying time reduction compared with infants given placebo ( @ vs @ , P = @ ; relative risk , @ ; @ % CI , @-@ @ ) .


Administration of L reuteri DSM @ significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic .


Tendinopathy is a difficult problem to manage and can result in significant patient morbidity .


Currently , the clinical use of platelet-rich plasma ( PRP ) in painful tendons is widespread but its efficacy remains controversial .


This study is a single-center , randomized double-blind controlled trial .


Eighty patients will be allocated to have ultrasound ( US ) - guided needling combined with a leukocyte-depleted ( that is , pure ) PRP or lidocaine each alternate week for a total of two interventions .


Outcome data will be collected before intervention , and at @ weeks , @ , @ , and @ months after intervention .


Changes in pain and activity levels , as assessed by Disabilities of the Arm , Shoulder and Hand ( DASH-E , Spanish version ) score , at @ months .


We will compare the percentage of patients in each group that achieve a successful treatment defined as a reduction of at least @ % in the DASH-E score .


Secondary outcome measures include changes in DASH-E at @ and @ months , changes in pain as assessed by the visual analogue scale ( VAS ) at the @-week , @ - , @ - , and @-month follow-up , changes in sonographic features and neovascularity , and percentage of patients in each group with adverse reactions at @ , @ , and @ months .


The results of this study will provide insights into the effect of pure PRP in tendon and may contribute to identifying the best protocol for PRP application in tendinopathies .


In Japan nursing care lags behind the growing population of patients with malignant pleural mesothelioma .


This study evaluated an educational program for nurses about caring for patients with malignant pleural mesothelioma in Japan .


In this randomized controlled study relative to care for malignant pleural mesothelioma , Knowledge , Difficulties and Attitude were measured at baseline , at post-test and at follow-up one month later .


The two-day program with a half-day follow-up program included lectures , group work , role-playing and group discussion .


@ participants were randomly assigned to the intervention group ( program , n = @ ) and control group ( n = @ ; self-study by a similar content handbook ) .


At baseline the groups showed no statistical differences in Knowledge ( p = @ ) , Difficulty ( p = @ ) and Attitude ( p = @ ) .


Completing the study were @ participants yielding @ in the intervention group and @ in the control group .


Human rights and privacy of participants were protected .


The Knowledge score was significantly higher in the intervention post-test ( t = @ , p = @ ) and follow-up test ( t = @ , p = @ ) .


Difficulty score was significantly lower in the intervention at post-test ( t = -@ , p = @ ) and follow-up test ( t = -@ , p = @ ) .


The Attitude score was significantly higher in the intervention post-test ( t = @ , p = @ ) and follow-up test ( t = @ , p = @ ) .


The two-way analysis of variance with repeated measures on time showed an interaction between time and group ; the subsequent simple main effect test found significant differences ( p = @-@ @ ) between groups for after-program and at follow-up and a significant difference ( p = @ ) in time only within the intervention group .


The educational program was effective in improving the nurses ' knowledge and attitude toward malignant pleural mesothelioma care and decreasing the difficulty in MPM care , therefore this program has potential for nurses ' in-service education throughout Japan .


Discontinuation of anti-hyperglycemic oral agents and initiation of insulin is recommended in certain clinical situations for inpatients with type @ diabetes ( T@D ) .


The effects on glucose turnover when these agents are acutely withdrawn are poorly understood and may be of importance when insulin therapy is initiated .


Our objective was to investigate alterations in glucose turnover after acute withdrawal of noninsulin therapy .


This was a randomized crossover study at a clinical research facility .


Participants included @ insulin-naive subjects with T@D .


Subjects attended two @-hour visits .


Standard therapy was discontinued and replaced by closed-loop insulin delivery during the intervention visit .


Usual anti-hyperglycemic therapy was continued during the control visit .


Systemic glucose appearance ( Ra ) and glucose disposal ( Rd ) were measured using a tracer dilution technique with iv -LSB- @,@ - ( @ ) H@ -RSB- glucose .


Plasma glucose profiles during both visits were comparable ( P = @ ) .


Glucose Ra increased during the day ( @ -LSB- @ , @ -RSB- vs @ -LSB- @ , @ ) mol/kg/min , P = @ ) and decreased overnight ( @ -LSB- @ , @ -RSB- vs @ -LSB- @ , @ -RSB- mol/kg/min , P = @ ) when the usual therapy was discontinued and replaced with insulin .


Increased daytime glucose Rd ( @ -LSB- @ , @ -RSB- vs @ -LSB- @ , @ -RSB- mol/kg/min , P = @ ) and decreased overnight Rd ( @ -LSB- @ , @ -RSB- vs @ -LSB- @ , @ -RSB- mol/kg/min , P = @ ) were observed when the usual therapy was discontinued , whereas daytime peripheral insulin sensitivity was reduced ( @ -LSB- @ , @ -RSB- vs @ -LSB- @ , @ -RSB- nmol/kg/min per pmol/L , P = @ ) .


In T@D , acute discontinuation of anti-hyperglycemic therapy and replacement with insulin increases postprandial Ra and reduces peripheral insulin sensitivity .


Insulin dose initiation may need to compensate for these alterations .


To evaluate the effect of perioperative gabapentin treatment for the prevention of persistent post-thoracotomy pain and to establish whether gabapentin has a significant therapeutic impact on acute postoperative pain .


Consecutive patients with pulmonary malignancies scheduled for anterior thoracotomy were enrolled in this randomized , double-blinded , placebo-controlled trial .


Patients were given @ mg gabapentin or placebo @ h before surgery followed by increasing doses during @ postoperative days : @ mg for day @ ; @ mg for day @ ; and @ mg for days @-@ .


Effective pain relief was provided with perioperative multimodal analgesia with epidural infusion of bupivacaine and morphine for @ h , and oral acetaminophen , ibuprofen and morphine .


The main outcome was persistent post-thoracotomy pain at @ months .


Secondary outcomes included measures of early postoperative post-thoracotomy pain , morphine requirements , recovery and analgesia-related adverse effects over the first @ weeks as well as persistent post-thoracotomy pain at @ months .


A total of @ patients were randomly assigned to the intervention or control group ; @ ( @ % ) patients were available for the @-day analysis , @ ( @ % ) for the @-month analysis and @ ( @ % ) for the @-month follow-up .


At @ months postoperatively , @ % of patients treated with gabapentin reported persistent post-thoracotomy pain compared with @ % in the placebo group ( P = @ ) .


No overall clinically or statistically significant differences were observed between groups receiving placebo and gabapentin , respectively , for the secondary outcome measures and treatment-related adverse events .


We found no evidence for the superiority of gabapentin over placebo for the treatment of acute pain following thoracotomy or for the prevention of persistent post-thoracotomy pain .


We previously reported an inverse association between flavonoid intake and breast cancer incidence , which has been confirmed by others , but no studies have considered simultaneously potential interactions of flavonoids with multiple genetic polymorphisms involved in biologically relevant pathways ( oxidative stress , carcinogen metabolism , DNA repair , and one-carbon metabolism ) .


To estimate interaction effects between flavonoids and @ polymorphisms in these four pathways on breast cancer risk , we used population-based data ( n = @ cases and @ controls ) and several statistical approaches , including conventional logistic regression and semi-Bayesian hierarchical modeling ( incorporating prior information on the possible biologic functions of genes ) , which also provides biologic pathway-specific effect estimates .


Compared to the standard multivariate model , the results from the hierarchical model indicate that gene-by-flavonoid interaction estimates are attenuated , but more precise .


In the hierarchical model , the average effect of the deleterious versus beneficial gene , controlling for average flavonoid intake in the DNA repair pathway , and adjusted for the three other biologically relevant pathways ( oxidative stress , carcinogen metabolism , and one-carbon metabolism ) , resulted in a @ % increase risk for breast cancer -LSB- odds ratio = @ ; @ % confidence interval ( CI ) = @ , @ -RSB- .


However , the CI was wide .


Based on results from the semi-Bayesian model , breast cancer risk may be influenced jointly by flavonoid intake and genes involved in DNA repair , but our findings require confirmation .


Improvement in quality of life ( QOL ) is a long term goal of drug treatment .


Although some brief interventions have been found to reduce illicit drug use , no trial among adult risky ( moderate non-dependent ) drug users has tested effects on health-related quality of life .


A single-blind randomized controlled trial of patients enrolled from February @ to November @ was conducted in waiting rooms of five federally qualified health centers .


@ adult primary care patients were identified as risky drug users using the WHO-ASSIST and @ ( @ % response ; @ intervention , @ control ) consented to participate in the trial .


Three-month follow-ups were completed by @ patients ( @ % ) .


Intervention patients received the QUIT intervention of brief clinician advice and up to two drug-use health telephone sessions .


The control group received usual care and information on cancer screening .


Outcomes were three-month changes in the Short Form Health Survey ( SF-@ ) mental health component summary score ( MCS ) and physical health component summary score ( PCS ) .


The average treatment effect ( ATE ) was non-significant for MCS ( @ points , p-value = @ ) and marginally significant for PCS ( @ points , p-value = @ ) .


The average treatment effect on the treated ( ATT ) was @ ( p-value = @ ) for MCS and @ ( p-value = @ ) for PCS .


The effect on PCS was stronger at higher ( above median ) baseline number of drug use days : ATE = @ , p-value = @ ; ATT = @ , p-value = @ .


The trial found a marginally significant effect on improvement in PCS , and significant and stronger effect on the SF-@ physical component among patients with greater frequency of initial drug use .


In subjects with hypercholesterolaemia , cholesterol values remain above guideline levels .


One of the limiting factors to the achievement of goals in such patients is therapeutic non-adherence .


The aim of this study is to assess the effectiveness of an intervention designed to improve control of hypercholesterolaemic patients , consisting of a combined strategy that would include the delivery of printed information , treatment-compliance check cards and the dispatch of text messages as complementary measures in support of the intervention at the general practitioner 's practice .


A randomised , parallel-group clinical trial will be conducted at the family medicine outpatient facilities of eight health centres in three of Spain 's Autonomous Regions ( Comunidades Autnomas ) , covering a total of @ subjects aged @years or over with diagnosis of hypercholesterolaemia .


Patients in the intervention group will be supplied with printed material with information on the disease and its management , mobile-telephone text messages with guideline summaries , reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance , and self-report cards to check compliance with recommendations .


Both groups - intervention and control - will receive routine recommendations from their physicians in accordance with current European clinical practice guidelines for hypercholesterolaemia and cardiovascular risk management .


As regards the measurements to be made , the main variable is the proportion of subjects who attain the low density lipoprotein cholesterol levels set as a target across a follow-up period of @months .


The secondary variables are as follows : adherence to recommendations on lifestyle and adherence to drug treatment ; variation in lipid profiles and cardiovascular risk levels ; appearance of cardiovascular events ; physical activity ; food consumption ; smoking habit ; anthropometric measures ; blood pressure ; health problems ; use of hypolipidaemic agents ; socio-demographic data ; beliefs and expectations about preventive recommendations ; and degree of satisfaction with the combined strategy .


Should this intervention prove effective , a recommendation could be issued on the application of this combined strategy to subjects with hypercholesterolaemia .


It is a simple , relatively inexpensive intervention .


In vitro : To assess the effect of common crushing techniques on particle size reduction ( PSR ) and in vitro drug-release kinetics of oxycodone DETERx ( herein DETERx ) and of a commercially available oxycodone extended-release ( ER ) tablet .


In vivo : To evaluate the impact of the most effective manipulation method identified in the in vitro study and the effect of chewing on the pharmacokinetics ( PK ) of DETERx relative to oxycodone solution .


In vitro : Mechanical manipulation of dosage forms using common household utensils .


In vivo : Open-label , randomized , active-controlled , crossover PK study .


In vivo : Forty-four healthy male and female volunteers .


In vitro : DETERx capsule contents and marketed comparator tablets were subjected to manipulation ( crushing ) using @ different household utensils .


Particle size and dissolution analysis were conducted .


In vivo : Subjects were randomly assigned to receive DETERx @-mg capsules intact , crushed , or chewed or oxycodone solution .


Serial blood samples were drawn for PK assessment .


In vitro : The utensils used to manipulate DETERx capsule contents were either ineffective in reducing the particle size or produced only a small change in the median particle size and dissolution rate relative to the marketed comparator .


In vivo : DETERx intact capsules provided significantly lower Cmax and longer Tmax values than oxycodone solution .


Manipulation of DETERx by crushing ( using the most effective method established in vitro ) or chewing resulted in bioequivalent plasma concentration-time profiles to the intact dosage form .


These mechanical manipulation and PK studies demonstrated that DETERx beads retained their ER properties after mechanical tampering and chewing by study subjects .


To observe the impacts of acupoint catgut embedding therapy and acupuncture-moxibustion therapy on the long-term efficacy and patient 's life quality in the treatment of allergic rhinitis .


Sixty-nine patients were randomized into the combined acupuncture-moxibustion and acupoint catgut embedding therapy group ( combined therapy group , @ cases ) and an acupuncture-moxibustion group ( @ cases ) .


In the acupuncture-moxibustion group , acupuncture was applied at Yingxiang ( LI @ ) , Shangyingxiang ( EX-HN @ ) , Yintang ( GV @ ) , Shangxing ( GV @ ) , Tongtian ( BL @ ) and Zusanli ( ST @ ) .


Moxibustion was applied at Zusanli ( ST @ ) , Feishu ( BL @ ) , Dazhui ( GV @ ) and Fengmen ( BL @ ) .


In the combined therapy group , on the basis of the treatment as acupuncture-moxibustion group , the catgut embedding therapy was applied at Feishu ( BL @ ) , Fengmen ( BL @ ) , Pishu ( BL @ ) , Shenshu ( BL @ ) , Zhongwan ( CV @ ) and Qihai ( CV @ ) .


The treatment duration was @ weeks in the two groups .


The clinical efficacy of allergic rhinitis and rhinoconjunctivitis quality of life questionnaire ( RQLQ ) score were observed before and after treatment as well as in the @-weeks follow-up after the end of treatment respectively .


The markedly effective rate was @ % ( @/@ ) in the combined therapy group and @ % ( @/@ ) in the acupuncture-moxibustion group after treatment .


The efficacy was similar between the two groups ( P > @ ) .


It was @ % ( @/@ ) in the combined therapy group and was @ % ( @/@ ) in the @-week follow-up after treatment , indicating the long-term efficacy in the combined therapy group was superior to that in the acupuncture-moxibustion group ( P < @ ) .


Scores of RQLO after treatment and in @-week follow-up after treatment in both groups were improved as compared with those before treatment ( all P < @ ) .


In @-week follow-up , the improvements in sleep and affection in the combined therapy group were superior to the acupuncture-moxibustion group ( @ + / - @ vs @ + / - @ , @ + / - @ vs @ + / - @ , both P < @ ) .


The acupoint catgut embedding therapy combined with acupuncture-moxibustion therapy are safe and effective in the treatment of allergic rhinitis and display the more roles in the long-term efficacy .


Osteoarthritis is a chronic disease with a multifactor etiology involving changes in bone alignment , cartilage , and other structures necessary to joint stability .


There is a need to investigate therapeutic resources that combine different wavelengths as well as different light sources ( low-level laser therapy and light-emitting diode therapy ) in the same apparatus for the treatment of osteoarthritis .


The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for individuals with osteoarthritis of the knee .


A double-blind , controlled , randomized clinical trial will be conducted involving patients with osteoarthritis of the knee .


Evaluations will be performed using functional questionnaires before and after the treatment protocols , in a reserved room with only the evaluator and participant present , and no time constraints placed on the answers or evaluations .


The following functional tests will also be performed : stabilometry ( balance assessment ) , dynamometry ( muscle strength of gluteus medius and quadriceps ) , algometry ( pain threshold ) , fleximeter ( range of motion ) , timed up-and-go test ( functional mobility ) , and the functional reach test .


The participants will then be allocated to three groups through a randomization process using opaque envelopes : exercise program , exercise program + phototherapy , or exercise program + placebo phototherapy , all of which will last for eight weeks .


The purpose of this randomized clinical trial is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program for osteoarthritis of the knee .


The study will support the practice based on evidence to the use of phototherapy in individuals with a diagnosis of osteoarthritis of the knee .


Data will be published after the study is completed .


Prescription opioids have substantial abuse potential .


This study compared the positive subjective drug effects of a newly developed extended-release ( ER ) oxycodone ( OC ) / acetaminophen ( acetyl-para-aminophenol -LSB- APAP -RSB- ) formulation with those of immediate-release ( IR ) OC/APAP .


This randomized , double-blind , active - and placebo-controlled , @-way crossover study enrolled healthy volunteers who were recreational prescription opioid users .


The protocol was approved by an institutional review board and all participants provided written informed consent .


Participants received single doses of intact ER and IR OC/APAP @/@ mg , intact ER and IR OC/APAP @/@ mg , crushed ER and IR OC/APAP @/@ mg , and placebo .


Peak subjective effects ( Emax ) , time to Emax , and area under the drug-effect curves for drug liking , drug high , and good drug effects were measured using visual analogue scales .


Least squares means with @ % confidence interval were compared using analysis of variance .


Among completers ( N = @ ) , intact ER OC/APAP produced delayed and lower peak effects versus IR OC/APAP .


Comparing intact tablets , the drug liking Emax ( least squares means -LSB- @ % confidence interval -RSB- ) was significantly lower for OC/APAP @/@ mg ( @ -LSB- @ to @ -RSB- ) than for IR OC/APAP @/@ mg ( @ -LSB- @ to @ -RSB- ; difference , -@ -LSB- -@ to -@ -RSB- ; P < @ ) .


Similar results were observed for intact ER and IR OC/APAP ( @ mg/@ mg ) .


Crushing ER OC/APAP @/@ mg further delayed these effects compared with the same dose of crushed IR OC/APAP and intact ER OC/APAP .


Extended-release OC/APAP produced lower subjective drug effects than IR OC/APAP .


Crushing ER OC/APAP further delayed onset of subjective effects compared with intact ER OC/APAP .


The ER OC/APAP may be less attractive for abuse than IR OC/APAP .


Teleophthalmology has the potential to reduce costs and inconveniences associated with frequent patient visits .


Evaluating teleophthalmology in the management of age-related macular degeneration ( AMD ) will allow for future implementation of this technology .


To evaluate teleophthalmology as a tool for the screening and monitoring of neovascular AMD .


Prospective , randomized clinical trial that included @ referral eyes for suspected neovascular AMD and @ eyes with stable neovascular AMD .


New referrals for patients with suspected neovascular AMD and patients with stable neovascular AMD were randomized into either routine or teleophthalmologic groups .


In the routine group , patients received clinical assessment and diagnostic imaging at a tertiary hospital-based retina clinic .


In the teleophthalmologic group , patients received basic examination and diagnostic imaging at a stand-alone teleophthalmologic site , where patient information and imaging studies were acquired and electronically sent over to tertiary hospital-based retina specialists .


Patients in the teleophthalmologic group were called back to the tertiary treatment center if the teleophthalmologic data set suggested pathology or was inconclusive for diagnosis .


Patient wait times for diagnosis and/or treatment , referral accuracy , and visual outcome .


For neovascular AMD screening , the average referral-to-diagnostic imaging time was @ days for the teleophthalmologic group and @ days for the routine group , for a difference of @ days ( @ % CI , @ to -@ days ; P = @ ) .


The average diagnostic imaging to treatment time was @ days for the teleophthalmologic group and @ days for the routine group , for a difference of @ days ( @ % CI , @ to -@ days ; P = @ ) .


For neovascular AMD monitoring , the average recurrence to treatment time was shorter for the routine group ( @ days ) compared with @ days for the teleophthalmologic group , for a difference of -@ days ( @ % CI , -@ to -@ days ; P < @ ) .


There was no difference identified between end-of-study visual acuities in the @ groups ( P = @ ) .


A delay of referral to treatment time could not be identified when comparing teleophthalmologic screening for suspected neovascular AMD with retinal specialist-based screening .


Teleophthalmologic monitoring for neovascular AMD recurrence resulted in longer wait times for treatment reinitiation , but no adverse visual outcomes were identified .


To evaluate safety and efficacy of weekly ( qw ) and every other week ( q@w ) dosing of sarilumab , a fully human anti-interleukin @ receptor ( anti-IL-@R ) monoclonal antibody , for moderate-to-severe rheumatoid arthritis ( RA ) .


In this dose-ranging study , patients ( n = @ ) with active RA , despite methotrexate , were randomly assigned to placebo or one of five subcutaneous doses/regimens of sarilumab : @mg q@w , @mg q@w , @mg qw , @mg q@w , @mg qw for @weeks , plus methotrexate .


The primary end point was ACR@ at Week @ .


Secondary endpoints included ACR@ , ACR@ , Disease Activity Score in @ joints ( C reactive protein ) .


Safety , pharmacokinetics , pharmacodynamics and efficacy in population subgroups were assessed .


The proportion of patients achieving an ACR@ response compared with placebo was significantly higher for sarilumab @mg qw ( @ % vs @ % , multiplicity adjusted p = @ ) .


Higher ACR@ responses were also attained with @mg q@w ( @ % ; unadjusted ( nominal ) p = @ ) and @mg q@w ( @ % ; unadjusted p = @ ) versus placebo .


Sarilumab @mg q@w reduced C reactive protein , which did not return to baseline between dosing intervals .


Infections were the most common adverse event ; none were serious .


Changes in laboratory values ( neutropenia , transaminases and lipids ) were consistent with reports with other IL-@R inhibitors .


Sarilumab improved signs and symptoms of RA over @weeks in patients with moderate-to-severe RA with a safety profile similar to reports with other IL-@ inhibitors .


Sarilumab @mg and sarilumab @mg q@w had the most favourable efficacy , safety and dosing convenience and are being further evaluated in Phase III .


We examined risk of newly detected human papillomavirus ( HPV ) infection and cervical abnormalities in relation to HPV type @/@ antibody levels at enrollment in PATRICIA ( Papilloma Trial Against Cancer in Young Adults ; NCT@ ) .


Using Poisson regression , we compared risk of newly detected infection and cervical abnormalities associated with HPV-@ / @ between seronegative vs seropositive women ( @-@ years ) in the control arm ( DNA negative at baseline for the corresponding HPV type -LSB- HPV-@ : n = @ ; HPV-@ : n = @ -RSB- ) .


High titers of naturally acquired HPV-@ antibodies and/or linear trend for increasing antibody levels were significantly associated with lower risk of incident and persistent infection , atypical squamous cells of undetermined significance or greater ( ASCUS + ) , and cervical intraepithelial neoplasia grades @/@ or greater ( CIN@ + , CIN@ + ) .


For HPV-@ , although seropositivity was associated with lower risk of ASCUS + and CIN@ + , no association between naturally acquired antibodies and infection was demonstrated .


Naturally acquired HPV-@ antibody levels of @ ( @ % confidence interval -LSB- CI -RSB- , @-@ ) , @ ( @ % CI , @-@ ) , and @ ( @ % CI , @-@ ) EU/mL were associated with @ % reduction of incident infection , @-month persistent infection , and ASCUS + , respectively .


Naturally acquired antibodies to HPV-@ , and to a lesser extent HPV-@ , are associated with some reduced risk of subsequent infection and cervical abnormalities associated with the same HPV type .


Children with severe cutaneous burn injury show persistent metabolic abnormalities , including inflammation and insulin resistance .


Such abnormalities could potentially increase their future risk for developing type @ diabetes mellitus ( T@DM ) and cardiovascular disease ( CVD ) .


This could be related to changes in body composition and fat distribution .


We studied body composition , fat distribution , and inflammatory cytokines changes in children with severe burn injury up to @ months from discharge .


Sixty-two boys and @ girls ( burn @ % of total body surface area ) were included .


We found a decrease in total body fat and subcutaneous peripheral fat at @ months ( @ % and @ % , respectively ; P < @ each ) .


An inverse correlation between the decrease in peripheral fat content at @ months and the extent of burn injury ( r = -@ , P = @ ) was also observed .


In addition , there was a @ % increase in serum tumor necrosis factor - ( TNF - ) ( P = @ vs. discharge ) and @ % decrease in serum interleukin-@ ( IL-@ ) ( P < @ vs. discharge ) over @ months after burn .


Severe burn injury in children is associated with changes in body fat content and distribution up to @ months from hospital discharge .


These changes , accompanied by persisting systemic inflammation , could possibly mediate the observed persistence of insulin resistance , predisposing burn patients to the development of T@DM and CVD .


To integrate group-based lifestyle sessions ( GBLS ) within prenatal care for gestational weight gain ( GWG ) management .


In Study @ , participants attended GBLS during prenatal care visits .


Participants in Study @ attended off-site GBLS whereby care providers were asked to discuss the program with patients .


Process and outcome evaluation were conducted through a mixed-methods approach .


In both pre-experimental feasibility studies , data provide preliminary support for GBLS ( eg , positive care provider and patient feedback , weight gain patterns ) as well as highlight areas for future research ( eg , lack of GWG management discussions , preference for GBLS location ) .


GBLS represents a promising approach to GWG management .


Future research should assess the generalizability , sustainably , and compatibility of GBLS within prenatal care .


Secondary hyperparathyroidism ( SHPT ) is a frequent complication of chronic kidney disease .


We evaluated AMG @ , a long-acting peptide agonist of the calcium-sensing receptor , to assess its safety , tolerability , and efficacy and to determine a safe and effective starting dose for subsequent phase @ studies .


The study was not designed to titrate AMG @ dosing to achieve a specific PTH treatment goal .


This is a multicenter , double-blind , randomized , placebo-controlled , dose-escalation study designed to evaluate the safety and efficacy of AMG @ administered thrice weekly by IV bolus at the end of hemodialysis for up to @ weeks .


Eligible subjects were enrolled in one of three cohorts and treated with @mg of AMG @ or placebo for @ weeks ( Cohort @ ) or @ or @mg of AMG @ or placebo for @ weeks ( Cohorts @ and @ ) .


The primary endpoint was mean percentage change from baseline in PTH during the efficacy assessment phase ( EAP ) in Cohorts @ and @ .


Analysis of the primary endpoint showed that treatment with AMG @ at @mg ( Cohort @ ) and @mg ( Cohort @ ) for up to @ weeks resulted in mean @ % and @ % reductions from baseline in PTH during the efficacy assessment phase , respectively ( p < @ for both cohorts compared to placebo group within the cohort ) .


A substantial proportion of subjects treated with AMG @ achieved PTH @pg/mL and @ % reduction in PTH from baseline in both cohorts .


The observed decreases in serum-corrected calcium were well tolerated and serum phosphate levels also tended to decrease .


The present clinical findings support the continued development of AMG @ as a treatment for SHPT in hemodialysis patients .


Although there is general agreement that parents should be involved in pediatric obesity treatment , few studies have investigated the effectiveness of interventions that target parents exclusively .


Moreover , the effectiveness of this approach has not been adequately assessed with racially diverse families , particularly African Americans ( AA ) , a group at high risk for elevated Body Mass Index ( BMI ) .


NOURISH ( Nourishing Our Understanding of Role modeling to Improve Support and Health ) is a culturally-sensitive parenting intervention targeting overweight ( AA ) children ( ages @-@ ; MBMI = @ % ile ) .


Families ( N = @ ; @ % AA , @ % White ) were randomly assigned to NOURISH or a control group .


NOURISH families significantly improved on child BMI from pre - to post-testing after adjustment for random effects , baseline BMI , and child race .


NOURISH parents were very satisfied with the intervention and would recommend it to other parents ; @ % strongly or moderately agreed that NOURISH helped them eat in a healthier manner .


These pilot data suggest that NOURISH is acceptable and , with refinement , offers promise for reducing pediatric BMI .


Outcomes , lessons learned , and parent feedback will inform a larger randomized controlled trial .


The eradication rate of @-day sequential therapy for Helicobacter pylori ( H. pylori ) infection was not satisfactory in Korea , probably due to antibiotic resistance .


To compare the treatment efficacy of @-day and @-day sequential therapy of conventional @-day proton pump inhibitor ( PPI ) triple therapy for the treatment of H. pylori infection .


A total of @ patients with H. pylori infection were randomly assigned to receive either @-day PPI triple therapy , @-day sequential therapy or @-day sequential therapy .


Eradication rate , drug compliance , and adverse events were compared among the three regimens .


The eradication rates by intention-to-treat analysis were @ % ( @ % CI : @-@ @ ; @ of @ patients ) , @ % ( @ % CI : @-@ @ ; @ of @ patients ) , and @ % ( @ % CI : @-@ @ ; @ of @ patients ) in the @-day PPI triple , @-day and @-day sequential therapy groups , respectively ( p = @ ) .


The eradication rates by per-protocol analysis were @ % ( @ % CI : @-@ @ ; @ of @ patients ) , @ % ( @ % CI : @-@ @ ; @ of @ patients ) , and @ % ( @ % CI : @-@ @ ; @ of @ patients ) in the @-day PPI triple , @-day and @-day sequential therapy groups , respectively ( p = @ ) .


There were no statistically significant differences between the three eradication therapy groups in regard to drug compliance and adverse events .


The @-day sequential therapy demonstrated improved eradication efficacy compared with @-day PPI triple and @-day sequential therapy in Korea .


We aimed to assess the impact of eplerenone on cardiovascular ( CV ) outcomes in STEMI without known heart failure , when initiated within @ h of symptom onset .


In this randomized , placebo-controlled , double-blind trial , we assigned @ patients with acute STEMI and without a history of heart failure to receive either eplerenone ( @-@ mg once daily ) or placebo in addition to standard therapy .


The primary endpoint was the composite of CV mortality , re-hospitalization , or , extended initial hospital stay , due to diagnosis of HF , sustained ventricular tachycardia or fibrillation , ejection fraction @ % , or elevated BNP/NT-proBNP at @ month or more after randomization .


BNP elevation was defined as BNP levels or values above @ pg/mL or NT-proBNP values above @ pg/mL ( in patients aged below @ ) ; above @ pg/mL ( age @-@ years ) or above @ pg/mL ( patients older than @ ) .


After a mean follow-up of @ months , the primary endpoint occurred in @ patients ( @ % ) in the eplerenone group and in @ patients ( @ % ) in the placebo group -LSB- adjusted hazard ratio ( HR ) , @ ; @ % confidence interval ( CI ) , @-@ @ ; P < @ -RSB- .


The primary endpoint was driven by a high BNP/NT-proBNP level ( adjusted HR , @ ; @ % CI , @-@ @ ; P < @ ) .


Adverse event rates were similar in both groups .


Serum potassium levels exceeded @ mmol/L in @ vs. @ % ( P = @ ) and were below @ mmol/L in @ vs. @ % of patients ( P = @ ) , in the eplerenone and placebo groups , respectively .


The addition of eplerenone during the acute phase of STEMI was safe and well tolerated .


It reduced the primary endpoint over a mean @ months follow-up mostly because of significantly lower BNP/NT-proBNP levels .


Additional studies are needed to clarify the role of early use of MRAs in STEMI patients without heart failure .


Weight-loss trials tend to recruit highly selective , non-representative samples .


Effective weight-loss approaches are needed for real-world challenging populations .


To test whether a small-changes intervention , delivered in groups or via telephone , promotes greater weight loss than standard obesity treatment in a predominantly male , high-risk Veteran population .


Data were collected in @-@ and analyzed in @ .


A three-arm , @-month randomized pragmatic effectiveness trial .


Four-hundred eighty-one overweight/obese participants from two Midwestern Veterans Affairs ( VA ) Medical Centers were randomly assigned to one of three programs : the @-month Aspiring to Lifelong Health ( ASPIRE ) weight-loss program delivered ( @ ) individually over the phone ( ASPIRE-Phone ) or ( @ ) in-person group sessions ( ASPIRE-Group ) ; compared to ( @ ) VA 's standard weight-loss program ( MOVE ! )


Twenty-eight sessions with a non-clinician coach via telephone or in-person groups using a small-changes obesity treatment approach compared to a @-@-session standard VA program .


Twelve-month change in weight ( kilograms ) .


Participants in all three arms lost significant ( p < @ ) weight at @ months .


Participants in the ASPIRE-Group arm lost significantly more weight at @ months than those in the other two treatment arms ( -@ kg , @ % CI = -@ , -@ , in ASPIRE-Group vs -@ kg , @ % CI = -@ , -@ , in ASPIRE-Phone and -@ kg , @ % CI = -@ , -@ ) in MOVE !


ASPIRE-Group resulted in greater improvements in all other anthropometric measures compared to MOVE !


at @ months ( p < @ ) and for all ( p < @ ) but waist circumference ( p = @ ) compared to ASPIRE-Phone .


Group-based delivery of the ASPIRE weight management program is more effective than MOVE !


and the phone-based version of ASPIRE at promoting sustained weight loss in a predominantly male population with multiple comorbidities .


The incremental benefits of group-based ASPIRE over the current MOVE !


program could yield significant population-level benefits if implemented on a large scale .


Disorders of homocysteine and B-vitamin metabolism represent a significant problem in clinical practice .


Establishing the diagnosis requires specialized tests with demanding preanalytical requirements .


To advance the detection of patients with these disorders , we developed a method for the simultaneous determination of cystathionine ( Cysta ) , methionine ( Met ) and total homocysteine ( tHcy ) in dried blood spots ( DBSs ) .


A punch from a DBS sample was mixed with a solution of isotopically labeled internal standards , and analytes were extracted using methanol/@ @ % formic acid/@ @ mol/L dithiothreitol .


The extract was injected into an LC-MS/MS system operating in MRM mode .


The analytical performance of the method employing DBS is adequate for its purpose and the type of sample .


Compared with Cysta , tHcy and Met plasma levels , our method exhibited a negative bias between -@ % and -@ % due to the lower concentrations of these analytes in erythrocytes .


The tHcy level and the Met/Cysta ratio in DBS enabled the clear detection of @ patients with disorders of transsulfuration and with genetic and nutritional remethylation defects .


The ease of collecting and transporting DBS samples may advance diagnostic procedures in patients with neuropsychiatric disorders and thromboembolism .


Consequently , this approach may facilitate detection and simplify the monitoring of patients with homocystinuria .


The effects of short course of corticosteroids on the metabolic processes and bone formation has not been well studied .


Our aim was to compare the efficacy , the side effects and the bone and lipid metabolisms in IBD patients using bolus or conventional tapering of methylprednisolone for @ weeks .


Nineteen IBD patients received intravenous methylprednisolone of @mg/kg for @ days tapered by @ mg per week .


Patients were prospectively randomized in two groups .


In `` conventional '' group ( I ) steroids were given daily .


In `` pulse '' group ( II ) weekly doses of steroids were given on special days of the week .


The body mass index ( BMI ) was measured before and after the corticosteroid therapy .


Blood samples were collected to assess glucose level , electrolytes , cholesterol and triglyceride levels , inflammatory parameters , cortisol , osteocalcin and crosslaps values .


Total body composition analysis was performed at the beginning and at the end of the steroid therapy .


In Group I , BMI increased , total body bone density decreased significantly at the end of the steroid therapy .


Body fat percent showed a tendency to be higher at the end of steroid therapy in Group I. Cholesterol level increased significantly in Group I patients .


The decrease in serum cortisol level was more remarkable in Group I vs. Group II after steroid therapy .


Less side-effect occurred in Group II vs. Group I.


Our results suggest that bolus tapering of corticosteroids may have more favorable short term outcome than conventional tapering that may revolutionize steroid therapy in IBD .


Compared with other countries , patients with chronic hepatitis C infection in Japan tend to be older , have more advanced liver disease , and are more likely to have been previously treated for hepatitis C.


We aimed to assess the efficacy and safety of an all-oral , fixed-dose combination of the hepatitis C virus NS@A inhibitor ledipasvir and the NS@B nucleotide polymerase inhibitor sofosbuvir with and without ribavirin for @ weeks in treatment-naive and previously treated Japanese patients with chronic genotype @ hepatitis C virus infection .


In this randomised , open-label study , we enrolled patients from @ clinical Japanese centres .


Patients were randomly assigned ( @:@ ) to receive either ledipasvir ( @ mg ) and sofosbuvir ( @ mg ) or ledipasvir , sofosbuvir , and ribavirin ( dosed according to the Japanese Copegus product label-ie , patients @ kg received @ mg daily , patients > @ kg to @ kg received @ mg daily , and patients > @ kg received @ mg daily ) orally once daily for @ weeks .


After completion or early discontinuation of treatment , patients were followed up off-treatment for @ weeks .


Eligible patients were at least @ years of age with chronic genotype @ hepatitis C virus infection with serum hepatitis C virus RNA concentrations of at least @ log@ IU/mL , creatinine clearance of at least @ mL/s , and a platelet count of at least @ ( @ ) per L.


An interactive web response system was used to manage patient randomisation and treatment assignment .


Randomisation was stratified by the presence or absence of cirrhosis for treatment-naive patients and stratified by presence or absence of cirrhosis and by previous treatment category ( relapser or breakthrough , non-responder , or interferon-intolerant ) for previously treated patients .


Within each strata , patients were sequentially assigned to either treatment with ledipasvir-sofosbuvir or ledipasvir-sofosbuvir plus ribavirin in a @:@ ratio with block size of @ .


The primary endpoint was sustained virological response @ weeks after completion of treatment ( SVR@ ) assessed in all patients who were randomly assigned and received at least one dose of study drug ; safety outcomes were assessed in all patients who received at least one dose of study drug .


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


Between Oct @ , @ and Dec @ , @ , @ patients were randomly assigned to treatment groups and received at least one dose of study treatment .


SVR@ was achieved in all @ ( @ % ) patients ( @ of @ treatment naive and @ of @ treatment experienced ) receiving ledipasvir-sofosbuvir ( @ % CI @-@ ) and @ ( @ % ) of @ patients ( @ of @ treatment naive and @ of @ treatment experienced ) receiving ledipasvir-sofosbuvir plus ribavirin ( @ % CI @-@ ) .


Of the @ patients with baseline NS@A resistant variants , @ ( @ % ) achieved SVR@ .


Two ( @ % ) of @ patients in the ledipasvir-sofosbuvir plus ribavirin group discontinued treatment because of adverse events .


The most common adverse events were nasopharyngitis ( @ -LSB- @ % -RSB- of @ ) , headache ( @ -LSB- @ % -RSB- of @ ) , and malaise ( nine -LSB- @ % -RSB- of @ ) in patients receiving ledipasvir-sofosbuvir ; and nasopharyngitis ( @ -LSB- @ % -RSB- of @ ) , anaemia ( @ -LSB- @ % -RSB- of @ ) , and headache in those receiving ledipasvir-sofosbuvir and ribavirin ( @ -LSB- @ % -RSB- of @ ) .


Although existing regimens for the treatment of hepatitis C virus are effective for many patients , medical needs remain unmet , particularly in Japan where the population with hepatitis C virus genotype @ is generally older and treatment-experienced , with advanced liver disease .


The efficacy , tolerability , and absence of drug-drug interactions of ledipasvir-sofosbuvir suggest that it could be an important option for treatment of genotype @ hepatitis C virus in Japanese patients .


The effect of fluticasone furoate nasal spray ( FFNS ) on growth in prepubescent children has not been evaluated .


To characterize the difference in mean prepubescent growth velocities , as determined by stadiometry , between patients treated continuously for @ year with FFNS @mcg once daily and placebo nasal spray .


This was a multicenter , randomized , double-blind , placebo-controlled , parallel-group @-week safety study .


Nasal symptom assessments were used as a measure of adherence .


Eligible patients were ages @ to < @ years at screening and had at least a @-year clinical history and diagnosis of perennial allergic rhinitis , including a positive skin test or specific IgE to an appropriate perennial allergen within the past year .


One hundred eighty-six patients in the FFNS group and @ patients in the placebo group completed the entire @-week treatment period .


During treatment , the least squares mean growth velocity was @ cm/y for the FFNS group and @ cm/y for the placebo group ; mean difference,-@ @ cm/y ( @ % CI,-@ @ to-@ @ cm/y ) .


Other safety assessments , including @-hour urinary cortisol excretion , were comparable between the treatment groups .


Daily reflective total nasal symptom scores declined similarly in both the FFNS and placebo groups .


Once-daily treatment with FFNS over @ weeks in prepubescent children resulted in a small reduction in growth velocity compared with placebo .


Clinicians will need to balance the reduction in growth observed with FFNS to its potential for clinical benefit .


To evaluate the effect of a multidisciplinary rehabilitation programme on disability , kinesiophobia , catastrophizing , pain , quality of life and gait disturbances in patients with chronic low back pain ( CLBP ) .


This was a parallel-group , randomised , superiority-controlled pilot study in which @ patients were randomly assigned to a programme consisting of motor training ( spinal stabilising exercises plus usual-care ) and cognitive-behavioural therapy ( experimental group , @ subjects ) or usual-care alone ( control group , @ subjects ) .


Before treatment , @ weeks later ( post-treatment ) , and @ months after the end of treatment , the Oswestry Disability Index , the Tampa Scale for Kinesiophobia , the Pain Catastrophizing Scale , a pain numerical rating scale , and the Short-Form Health Survey were assessed .


Spatio-temporal gait parameters were also measured by means of an electronic walking mat .


A linear mixed model for repeated measures was used for each outcome measure .


The programme had significant group ( p = @ ) , time ( p < @ ) , and time-by-group interaction ( p < @ ) effects on disability , with the experimental group showing an improvement after training of about @ % ( @ % in the control group ) .


The analyses of kinesiophobia , catastrophizing , and the quality of life also revealed significant time , group , and time-by-group interaction effects in favour of the experimental group , and there was a significant effect of time on pain .


Both groups showed a general improvement in gait parameters , with the experimental group increasing cadence significantly more .


The multidisciplinary rehabilitation programme including cognitive-behavioural therapy was superior to the exercise programme in reducing disability , kinesiophobia , catastrophizing , and enhancing the quality of life and gait cadence of patients with CLBP .


Vascular endothelial growth factor ( VEGF ) promotes angiogenesis , a mediator of disease progression in cervical cancer .


Bevacizumab , a humanized anti-VEGF monoclonal antibody , has single-agent activity in previously treated , recurrent disease .


Most patients in whom recurrent cervical cancer develops have previously received cisplatin with radiation therapy , which reduces the effectiveness of cisplatin at the time of recurrence .


We evaluated the effectiveness of bevacizumab and nonplatinum combination chemotherapy in patients with recurrent , persistent , or metastatic cervical cancer .


Using a @-by-@ factorial design , we randomly assigned @ patients to chemotherapy with or without bevacizumab at a dose of @ mg per kilogram of body weight .


Chemotherapy consisted of cisplatin at a dose of @ mg per square meter of body-surface area , plus paclitaxel at a dose of @ or @ mg per square meter or topotecan at a dose of @ mg per square meter on days @ to @ , plus paclitaxel at a dose of @ mg per square meter on day @ .


Cycles were repeated every @ days until disease progression , the development of unacceptable toxic effects , or a complete response was documented .


The primary end point was overall survival ; a reduction of @ % in the hazard ratio for death was considered clinically important .


Groups were well balanced with respect to age , histologic findings , performance status , previous use or nonuse of a radiosensitizing platinum agent , and disease status .


Topotecan-paclitaxel was not superior to cisplatin-paclitaxel ( hazard ratio for death , @ ) .


With the data for the two chemotherapy regimens combined , the addition of bevacizumab to chemotherapy was associated with increased overall survival ( @ months vs. @ months ; hazard ratio for death , @ ; @ % confidence interval , @ to @ ; P = @ in a one-sided test ) and higher response rates ( @ % vs. @ % , P = @ ) .


Bevacizumab , as compared with chemotherapy alone , was associated with an increased incidence of hypertension of grade @ or higher ( @ % vs. @ % ) , thromboembolic events of grade @ or higher ( @ % vs. @ % ) , and gastrointestinal fistulas of grade @ or higher ( @ % vs. @ % ) .


The addition of bevacizumab to combination chemotherapy in patients with recurrent , persistent , or metastatic cervical cancer was associated with an improvement of @ months in median overall survival .


( Funded by the National Cancer Institute ; GOG @ ClinicalTrials.gov number , NCT@ . )


The anterolateral approach is a commonly used technique for total hip replacement .


It requires the detachment of a large part of the gluteus medius muscle .


However , it is known that this muscle has a great impact on hip stability .


Using the percutaneous assisted approach the damage to the gluteus medius can be limited .


The purpose of this study is to compare the effect of the percutaneous assisted approach with the anterolateral approach on postoperative functional outcome .


This study uses a prospective , randomized , parallel-group design with blinded assessment and unblinded treatment to compare the percutaneous assisted approach with the anterolateral approach in total hip replacement surgery .


The postoperative results of patients operated on using the percutaneous assisted approach will be compared with those of patients operated on using the anterolateral approach .


Prior to surgery patients will undergo baseline measurements .


These will consist of gluteus medius measurements ( surface-electromyography , strength measurements of abductors and quadriceps and the Trendelenburg test ) , questionnaires ( Oxford Hip Score and @-item Short Form Health Survey ) and functional measures ( the Timed Get-Up-and-Go test , Five times Sit-to-Stand test and Six-Minute Walk test ) .


These measurements will be repeated four and @ weeks after surgery .


After surgery both groups will receive usual care .


The gluteus medius is the main stabilizer of the hip joint .


Therefore , we assume that functional outcome and gluteus medius function of patients after the percutaneous assisted approach will be better than after the anterolateral approach .


To determine and compare the adverse events and long-term effectiveness for patients with small hepatocellular carcinoma ( HCC ) ( @cm ) treated by percutaneous radiofrequency ablation ( RFA ) or hepatectomy .


Small HCC from @ patients were randomized into either percutaneous RFA therapy or hepatectomy group , and the effectiveness and complications of two treatment modalities were analyzed .


The complications of post-RFA or hepatectomy , the complete treatment rate , treatment-related mortality , and disease-free and overall survival rate were followed up and conducted .


In patients with small HCC , complete remission rates were achieved in @ % and @ % in the percutaneus RFA and hepatectomy groups , respectively ( P > @ ) .


Hepatic function at day-@ status post-treatment , including albumin and bilirubin levels , were significantly worse in the hepatectomy group ( P < @ ) .


Compared with the RFA group , the incidence of postoperative complications ( @ % vs @ % ) and hospital stay ( @ vs @ ) were significantly higher in the hepatectomy group ( P < @ ) .


After a mean follow-up of @ months , @ patients ( @ % ) in the RFA group and @ patients ( @ % ) in the hepatectomy group developed a recurrence ( P > @ ) .


There was no significant difference of the disease-free and overall survival rates at @ , @ , and @ years between the RFA group and the surgical hepatectomy group ( P = @ and P = @ , respectively ) .


In patients with small HCC , percutaneous RFA showed similar local control and long-term survival compared with hepatectomy .


Importantly , percutaneous RFA are accompanied with a lower complication rate and shorter hospital stay day .


Burned patients have increased level of mortality , possibly due to late introduction of enteral feeding .


The aim of this study was to compare the benefits and safety of very early enteral nutrition introduction compared to the normal diet among burns patients in an intensive care unit .


Participants consisted of @ patients , aged @-@ years ( mean age @ years ) , @ men and @ women , with burns that covered more than @ % of the body .


The intervention group consisted of @ subjects fed via introduced nasojejunal probe that started within four hours after admission to the hospital .


The control group consisted of fifty patients fed in standard manner per os ( three standard hospital meals ) immediately after the first wound dressing .


The average decline BMI in control group was @ kg/m@ , while the average reduction in BMI in the intervention group was @ kg/m@ ( p < @ ) .


The largest drop of albumin concentration in the control group was @ % , whereas in the intervention group was @ % .


( p < @ ) .


The greatest decrease of transferrin concentration in the control group was @ % , while the average reduction in the intervention group was @ % .


C-reactive protein values were statistically higher in control group ( p < @ ) .


Intervention group had lower rate of complications and infection rates .


Enteral nutrition in burned patients should begin within few hours of burn onset .


Such approach leads to better outcomes , reduces complications , and improves nutritional profile .


The purpose of this study was to identify optimal target propofol and remifentanil concentrations to avoid a gag reflex in response to insertion of an upper gastrointestinal endoscope .


Patients presenting for endoscopy received target-controlled infusions ( TCI ) of both propofol and remifentanil for sedation-analgesia .


Patients were randomized to @ groups of fixed target effect-site concentrations : remifentanil @ ngmL ( REMI @ ) or @ ngmL ( REMI @ ) and propofol @ gmL ( PROP @ ) or @ gmL ( PROP @ ) .


For each group , the other drug ( propofol for the REMI groups and vice versa ) was increased or decreased using the `` up-down '' method based on the presence or absence of a gag response in the previous patient .


A modified isotonic regression method was used to estimate the median effective Ce ,@ from the up-down method in each group .


A concentration-effect ( sigmoid Emax ) model was built to estimate the corresponding Ce ,@ for each group .


These data were used to estimate propofol bolus doses and remifentanil infusion rates that would achieve effect-site concentrations between Ce ,@ and Ce ,@ when a TCI system is not available for use .


One hundred twenty-four patients were analyzed .


To achieve between a @ % and @ % probability of no gag response , propofol TCIs were between @ and @ gmL ( that could be achieved with a bolus of @ mgkg ) when remifentanil TCI was fixed at @ ngmL , and target propofol TCIs were between @ and @ gmL ( that could be achieved with a bolus of @ mgkg ) when remifentanil TCI was fixed at @ ngmL .


Remifentanil ranges were @ to @ ngmL and @ to @ ngmL when propofol was fixed at @ and @ gmL , respectively .


We identified a set of propofol and remifentanil TCIs that blocked the gag response to endoscope insertion in patients undergoing endoscopy .


Propofol bolus doses and remifentanil infusion rates designed to achieve similar effect-site concentrations can be used to prevent gag response when TCI is not available .


Total atrial conduction time ( TACT ) is the most important parameter in predicting the development of new-onset atrial fibrillation .


We investigated the effect of cilostazol therapy on TACT in patients with peripheral artery disease .


Thirty patients with peripheral artery disease were treated with cilostazol ( @ mg/day ) for @ months .


The baseline echocardiographic total atrial conduction time parameter was compared with the @-month follow-up .


The TACT duration was decreased in all patients compared with the baseline after therapy ( @ @ vs. @ @ milliseconds , p < @ ) .


However , left atrial ( LA ) diameter was not changed with the therapy .


The reduction of TACT duration was correlated with the increase in mitral E wave velocity/mitral A wave velocity ratio ( r = -@ , p < @ ) .


Our results showed that @ mg cilostazol treatment decreased TACT duration in patients with peripheral artery disease , which may also prevent the development and/or recurrence of atrial fibrillation ( AF ) .


Protease-activated receptor @ antagonism with vorapaxar represents a novel strategy for platelet inhibition .


In TRACER , vorapaxar was compared with placebo plus standard of care among @,@ patients with non-ST-segment elevation acute coronary syndromes .


We anticipated that most patients would have received clopidogrel as part of standard care .


We investigated the modification of vorapaxar 's effect associated with clopidogrel use over time .


The marginal structural model method was used to estimate causal modification of vorapaxar effect by use of clopidogrel over time .


The primary outcomes were the composite of cardiovascular death , myocardial infarction , or stroke and Global Use of Strategies to Open Occluded Coronary Arteries moderate or severe bleeding .


The event accrual period excluded the time during which clopidogrel was clinically warranted .


Among @,@ patients who received study medication , @,@ ( @ % ) received clopidogrel before randomization , of whom @ % stopped later in the trial ( median time to stoppage @ days with placebo ; interquartile range -LSB- IQR -RSB- @-@ ) ( @ days with vorapaxar ; IQR @-@ ) .


In total , @,@ ( @ % ) patients were not on clopidogrel at randomization , of whom @ % started afterward ( median time to start @ days ; IQR @-@ ) .


During the period of event accrual , vorapaxar was associated with a @ % reduction in the composite of cardiovascular death , myocardial infarction , or stroke when used with clopidogrel ( hazard ratio -LSB- HR -RSB- @ ; @ % CI @-@ @ ) and a @ % reduction when used without clopidogrel ( HR @ ; @ % CI @-@ @ ) ( interaction ; P = @ ) .


The hazard of Global Use of Strategies to Open Occluded Coronary Arteries bleeding with vorapaxar was not significantly different without clopidogrel ( HR @ ; @ % CI @-@ @ ) or with clopidogrel ( HR @ ; @ % CI @-@ @ ) ( interaction ; P = @ ) .


We observed no interaction between vorapaxar and clopidogrel after non-ST-segment elevation acute coronary syndromes on efficacy or safety outcomes , supporting a complementary role of protease-activated receptor @ and P@Y@ antagonism .


To test whether combining bevacizumab , an anti-vascular endothelial growth factor treatment , with endocrine therapy ( ET ) could potentially delay the emergence of resistance to ET .


A multicenter , randomized , open-label , phase III , binational ( Spain and Germany ) study added bevacizumab ( @ mg/kg every @ weeks ) to ET ( ET-B ; letrozole or fulvestrant ) as first-line therapy in postmenopausal patients with human epidermal growth factor receptor @ ( HER@ ) - negative and hormone receptor-positive advanced breast cancer .


We compared progression-free survival ( PFS ) , overall survival ( OS ) , overall response rate ( ORR ) , response duration ( RD ) , time to treatment failure ( TTF ) , clinical benefit rate ( CBR ) , and safety .


From @ patients recruited ( @ to @ ) , @ were analyzed by intent to-treat ( @ patients on ET and @ patients on ET-B ) .


Median age was @ years , @ patients ( @ % ) had Eastern Cooperative Oncology Group performance status of @ , @ patients ( @ % ) had visceral metastases , and @ patients ( @ % ) and @ patients ( @ % ) had received prior chemotherapy or ET , respectively .


Median PFS was @ months in the ET arm and @ months in the ET-B arm ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


ORR , CBR , and RD with ET versus ET-B were @ % versus @ % ( P < @ ) , @ % versus @ % ( P = @ ) , and @ months versus @ months ( P = @ ) , respectively .


TTF and OS were comparable in both arms .


Grade @ to @ hypertension , aminotransferase elevation , and proteinuria were significantly higher in the ET-B arm .


Eight patients ( @ % ) receiving ET-B died during study or within @ days of end of treatment .


The addition of bevacizumab to ET in first-line treatment failed to produce a statistically significant increase in PFS or OS in women with HER@-negative/hormone receptor-positive advanced breast cancer .


Secretory phospholipase A@ ( sPLA@ ) generates bioactive phospholipid products implicated in atherosclerosis .


The sPLA@ inhibitor varespladib has favorable effects on lipid and inflammatory markers ; however , its effect on cardiovascular outcomes is unknown .


To determine the effects of sPLA@ inhibition with varespladib on cardiovascular outcomes .


A double-blind , randomized , multicenter trial at @ academic and community hospitals in Europe , Australia , New Zealand , India , and North America of @ patients randomized within @ hours of presentation of an acute coronary syndrome ( ACS ) to either varespladib ( n = @ ) or placebo ( n = @ ) with enrollment between June @ , @ , and March @ , @ ( study termination on March @ , @ ) .


Participants were randomized to receive varespladib ( @ mg ) or placebo daily for @ weeks , in addition to atorvastatin and other established therapies .


The primary efficacy measure was a composite of cardiovascular mortality , nonfatal myocardial infarction ( MI ) , nonfatal stroke , or unstable angina with evidence of ischemia requiring hospitalization at @ weeks .


Six-month survival status was also evaluated .


At a prespecified interim analysis , including @ primary end point events , the independent data and safety monitoring board recommended termination of the trial for futility and possible harm .


The primary end point occurred in @ patients ( @ % ) treated with varespladib compared with @ patients ( @ % ) treated with placebo ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ; log-rank P = @ ) .


Varespladib was associated with a greater risk of MI ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; HR , @ ; @ % CI , @-@ @ ; log-rank P = @ ) .


The composite secondary end point of cardiovascular mortality , MI , and stroke was observed in @ patients ( @ % ) in the varespladib group and @ patients ( @ % ) in the placebo group ( HR , @ ; @ % CI , @-@ @ ; P = @ ) .


In patients with recent ACS , varespladib did not reduce the risk of recurrent cardiovascular events and significantly increased the risk of MI .


The sPLA@ inhibition with varespladib may be harmful and is not a useful strategy to reduce adverse cardiovascular outcomes after ACS .


Postoperative nausea and vomiting ( PONV ) occur frequently after laparoscopic bariatric surgery .


The combination of haloperidol , dexamethasone , and ondansetron may reduce these undesirable events .


The aim of this study was to evaluate the intensity of nausea and pain , the number of vomiting episodes , and morphine consumption in postoperative ( PO ) obese patients undergoing laparoscopic sleeve gastrectomy ( LSG ) .


A clinical , randomized , controlled , double-blind study conducted with @ patients with body mass index @ kg.cm ( -@ ) .


Patients were divided into three groups of @ individuals to receive ondansetron @ mg ( Group O ) ; ondansetron @ mg and dexamethasone @ mg ( Group OD ) ; and ondansetron @ mg , dexamethasone @ mg , and haloperidol @mg ( Group HDO ) .


We evaluated the intensity of nausea and pain using the verbal numeric scale , cumulative number of vomiting episodes , and morphine consumption in the period of @-@ , @-@ , @-@ , and @-@ hours postoperatively .


Nausea intensity was lower in Group HDO compared to Group O ( p = @ ) , pain intensity was lower in Group HDO compared to Group O ( p = @ ) , and morphine consumption was lower in Group HDO compared to Group O ( p = @ ) .


There was no difference between groups regarding the number of vomiting episodes ( p = @ ) .


The combination of haloperidol , ondansetron , and dexamethasone reduced nausea and pain intensity and morphine consumption in postoperative obese patients undergoing LSG .


We determined the effect of an intensive lifestyle intervention on the prevalence , incidence and resolution of bothersome nocturia , increased daytime urinary voiding and urinary incontinence in overweight/obese men with type @ diabetes after @ year in the Look AHEAD trial .


A subset of male Look AHEAD participants was selected for this secondary data analysis .


Overall @,@ men with an average ( mean SD ) age of @ @ years and body mass index of @ @ kg/m ( @ ) were randomized to an intensive lifestyle intervention or diabetes support and education group .


All participants self-reported information regarding incontinence , nocturia and daytime urinary voiding at entry and @ year .


After @ year the intensive lifestyle intervention group lost significantly more weight than the diabetes support and education group ( @ % @ % vs @ % @ % , respectively ; p < @ ) .


The odds of prevalent urinary incontinence at @ year were reduced by @ % in the intensive lifestyle intervention group compared to the diabetes support and education group .


The prevalence of urinary incontinence decreased from @ % to @ % in the intensive lifestyle intervention group and increased from @ % to @ % in the diabetes support and education group .


The intensive lifestyle intervention group also had increased odds of urinary incontinence resolving ( OR @ , @ % CI @-@ @ , p = @ and @ % vs @ % , p = @ ) and trend toward reduced odds of new onset , incident urinary incontinence ( OR @ , @ % CI @-@ @ , p = @ ) compared with the diabetes support and education arm .


In contrast , no differences between intensive lifestyle intervention and diabetes support and education were seen at @ year for frequency of nocturia or frequency of daytime voiding .


Intensive lifestyle intervention should be considered for the treatment of urinary incontinence in overweight/obese men with type @ diabetes .


This study is conducted to investigate an optimal timing of sequential noninvasive positive pressure ventilation ( NPPV ) applied for patients with acute exacerbations of chronic obstructive pulmonary disease ( AECOPD ) .


Application of NPPV for @ patients was randomly observed in the conditions of a @-hour spontaneous breathing trial ( SBT-@ ) and pulmonary infection control ( PIC ) window .


Efficiency of NPPV in treatment of the patients , an incidence rate of tracheal reintubation , length of time for patients received invasive mechanical ventilation , and a morbidity rate of ventilator-associated pneumonia were examined in each group of @ patients .


The incidence rates for the patients treated successfully with NPPV and for tracheal reintubation were shown as @ and @ , and @ and @ in SBT-@ and PIC , respectively ( both p < @ ) .


Length of time ( hour ) for use of the invasive ventilation was @ and @ in SBT-@ and PIC , respectively ( p < @ ) .


There was a similar morbidity rate of ventilator-associated pneumonia seen in both groups .


SBT-@ would be the optimal timing considered to use NPPV for AECOPD patients based on a high success rate and a low risk of tracheal reintubation .


To explore the effect of nursing intervention on the prevention of burns in warm needling moxibustion .


Two hundred patients received warm needling treatment were collected from January to December @ and were randomized into an observation group and a control group , @ cases veceived ten hundreds of treatment in each group .


In the control group , the routine nursing was applied in warm needling moxibustion .


In the observation group , on the basic method as the control group , the nursing intervention was used .


The burns incidence and the satisfaction of patients in warm needling moxibustion were recorded in the patients of the two groups .


The burns incidence was @ % ( @/@ ) in the observation group , which was lower apparently than @ % ( @/@ ) in the control group ( P < @ ) .


The satisfaction of patients in warm needling moxibustion was @ % ( @/@ ) in the observation group , which was higher obviously than @ % ( @/@ ) in the control group ( P < @ ) .


The nursing intervention prevents effectively from burns in warm needling moxibustion , reduces medical injuries , avoids the pains of patients and plays the active role in the patient satisfaction .


The macro - and microcirculation disease , in patients with type @ diabetes mellitus ( T@DM ) , induces ischemic wounds of the lower limbs .


We have tried to reduce the aggregation of red blood cells and to improve the O@ supply to the tissues and speed the healing of ulcers in T@DM patients .


We enrolled @ obese subjects without glucose intolerance ( group A ; BMI greater than @ kg/m@ ) , @ obese adults intolerant to glucose ( group B ) and two subgroups , groups C and D , with T@DM and with leg ulcers .


The groups A , B and C were treated with PESF .


Body weight , O@ extraction , the capillary pulse , blood pressure and the surface of the ulcers were monitored .


The technique PESF shows to have positive effects on the metabolism , on the reduction of body weight in the groups A and B , increasing extraction of O@ in group C and increase the speed of healing of wounds in group C compared to group D.


In group A , there was a significant reduction in systolic and diastolic blood pressure .


The technique PESF has affected the metabolic processes and the speed of wound healing ulcer in patients with T@DM .


Labor induction in post-term pregnancy is considered as a conventional process of mothers ' care .


Shiatsu technique is one of the complementary methods which use for post-term pregnancy induction .


Therefore , the researchers decided to examine the effect of Shiatsu technique on the induction of post-term pregnancy .


This is a randomized control trials which conducted on @ women with post-term pregnancy who referred to consulting clinic at Ali - Ibn - Abi - Talib Hospital , in Zahedan-Iran in @-@ .


Participants were selected based on random table .


The participants divided into two groups : the first was shiatsu technique and the second group was control group ( routine procedure ) .


Shiatsu technique was conducted on the participants of intervention group for @s on three points by an experienced midwife .


The gathered data analyzed by SPSS version @ and comparing tests were t-students tests , chi-square .


Mothers ages range were between @ to @ years ( mean @-@ @ ) in shiatsu and @ to @ years ( mean @-@ @ ) in control group .


Regarding spontaneous initiation of labor , @ women ( @ % ) in Shiatsu group had spontaneous initiation of labor , whereas the number of women was only @ ( @ % ) in control group .