The aim of our study was to determine whether the combination of intratympanic ( IT ) corticosteroid with melatonin could be associated with decreased tinnitus in patients with unilateral acute idiopathic tinnitus developed within @months .


We evaluated this hypothesis through a prospective , randomized , controlled , double-blinded trial .


Patients included in the study were randomly allocated into two groups : Group A - comprising @ patients , received melatonin and IT dexamethazone , and Group B - including @ patients receiving melatonin alone .


After @ months , improvement in tinnitus was assessed using different outcome measures : tinnitus loudness score , tinnitus awareness score , Tinnitus Handicap Inventory ( THI ) , Pittsburgh Sleep Quality Index ( PSQI ) and Beck Depression Inventory ( BDI ) .


We have demonstrated significant improvements in each of the above mentioned outcomes subsequent to treatment in both groups .


However , patients in the IT dexamathazone and melatonin group attained statistically significant better outcomes .


Besides , the differences in improvement rate and cure rate were highly significant between the two groups , favoring the IT dexamethazone and melatonin group .


Our preliminary study demonstrated that IT dexamethazone plus melatonin is efficient in improvement of idiopathic unilateral tinnitus developed within @ months .


This study aimed to assess the predictive validity of the Alcohol Use Disorders Identification Test ( AUDIT ) among adult prisoners with respect to hazardous drinking following release , and identify predictors of post-release hazardous drinking among prisoners screening positive for risk of alcohol-related harm on the AUDIT .


Data came from a survey-based longitudinal study of @ sentenced adult prisoners in Queensland , Australia .


Baseline interviews were conducted pre-release with follow-up at @ and @ months post-release .


We calculated sensitivity , specificity and area under the receiver operating characteristic ( AUROC ) to quantify the predictive validity of the AUDIT administered at baseline with respect to post-release hazardous drinking .


Other potential predictors of hazardous drinking were measured by self-report and their association with the outcome was examined using logistic regression .


At a cut-point of @ or above , sensitivity of the AUDIT with respect to hazardous drinking at @-month follow-up was @ % ( @ % CI : @-@ @ % ) and specificity was @ % ( @ % CI : @-@ @ % ) .


The AUROC was @ ( @ % CI : @-@ @ ) , indicating moderate accuracy .


Among those scoring @ or above , high expectations to drink post-release ( AOR : @ ; @ % CI : @-@ @ ) and past amphetamine-type stimulant ( ATS ) use ( AOR : @ ; @ % CI : @-@ @ ) were significantly associated with hazardous drinking at @ months post-release .


Results were similar at @ months .


Among adult prisoners in our sample , pre-release AUDIT scores predicted hazardous drinking six months after release with acceptable accuracy , sensitivity and specificity .


Among prisoners screening positive on the AUDIT , expectations of post-release drinking and ATS use are potential targets for intervention to reduce future hazardous drinking .


Clinical outcomes and the effects of oral anticoagulants among patients with acute coronary syndrome ( ACS ) and either a history of or acute heart failure ( HF ) are largely unknown .


We aimed to assess the relationship between prior HF or acute HF complicating an index ACS event and subsequent clinical outcomes and the efficacy and safety of apixaban compared with placebo in these populations .


High-risk patients were randomly assigned post-ACS to apixaban @ mg or placebo twice daily .


Median follow-up was @ ( @-@ ) months .


The primary outcome was cardiovascular death , myocardial infarction , or stroke .


The main safety outcome was thrombolysis in myocardial infarction major bleeding .


Heart failure was reported in @,@ patients ( @ % ) , either as prior HF ( @,@ -LSB- @ % -RSB- ) or acute HF ( @,@ -LSB- @ % -RSB- ) .


Patients with HF had a very high baseline risk and were more often managed medically .


Heart failure was associated with a higher rate of the primary outcome ( prior HF : adjusted hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ @ , P < @ , acute HF : adjusted HR @ , @ % CI @-@ @ , P < @ ) and cardiovascular death ( prior HF : HR @ , @ % CI @-@ @ , acute HF : adjusted HR @ , @ % CI @-@ @ ) .


Patients with acute HF also had significantly higher rates of thrombolysis in myocardial infarction major bleeding ( prior HF : adjusted HR @ , @ % CI @-@ @ , P = @ , acute HF : adjusted HR @ , @ % CI @-@ @ , P = @ ) .


There was no statistical evidence of a differential effect of apixaban on clinical events or bleeding in patients with or without prior HF ; however , among patients with acute HF , there were numerically fewer events with apixaban than placebo ( @ vs @ , HR @ , @ % CI @-@ @ , interaction P = @ ) , a trend that was not seen in patients with prior HF or no HF .


In high-risk patients post-ACS , both prior and acute HFs are associated with an increased risk of subsequent clinical events .


Apixaban did not significantly reduce clinical events and increased bleeding in patients with and without HF ; however , there was a tendency toward fewer clinical events with apixaban in patients with acute HF .


It was the aim of this study to find an optimal therapeutic regimen of transarterial chemoembolization ( TACE ) by comparing the efficacy of chemoembolization with different anticancer agents in hepatocellular carcinoma ( HCC ) patients .


A single-blind , three-group parallel , randomized trial was conducted in Guangdong General Hospital , Guangzhou , China , with patients with biopsy-confirmed HCC .


Group @ received single-drug ( doxorubicin ) chemoembolization , while group @ received double-drug ( doxorubicin and mitomycin C ) chemoembolization .


Patients in group @ were treated with triple-drug ( doxorubicin , mitomycin C , and gemcitabine ) chemoembolization .


Lipiodol was used as embolization agent in all protocols .


We compared the overall survival ( OS ) , time to progression ( TTP ) , and objective response rate ( ORR ) between groups .


Response assessment was performed according to modified RECIST ( Response Evaluation Criteria In Solid Tumors ) criteria .


Between January @ and January @ , @ patients ( group @ , n = @ ; group @ , n = @ ; group @ , n = @ ) were recruited .


The OS and TTP in groups @ , @ , and @ were @ and @ , @ and @ , and @ and @ months , respectively .


OS and TTP were statistically significant among groups ( p = @ and p = @ ) .


The ORR was @ , @ , and @ % , respectively .


The ORR was significantly different across the three groups ( p < @ ) .


TACE with multiple chemotherapeutic agents might significantly increase survival and tumor response ; additionally , gemcitabine was likely to have an advantage in improving the prognosis of HCC patients .


@ S. Karger AG , Basel .


Many patients with type @ diabetes mellitus ( T@DM ) on insulin therapy have inadequate glycaemic control .


In such cases , Dutch guidelines recommend unlimited up-titration of insulin , yet in practice many patients never reach their glycaemic target .


Clinical evidence shows that dapagliflozin-a highly selective sodium-glucose cotransporter @ inhibitor-meets a need for these patients , i.e. by reducing glycated haemoglobin levels and bodyweight .


We estimated the cost effectiveness and cost utility of adding dapagliflozin to insulin compared with not adding dapagliflozin in patients with T@DM who have inadequate glycaemic control while on insulin .


The cost effectiveness of dapagliflozin was estimated using the Cardiff Diabetes Model , using direct comparative efficacy data from a randomized placebo-controlled trial ( ClinicalTrials.gov identifier NCT@ ) .


In this trial , up-titration of insulin was allowed in case of severe glycaemic imbalance .


Risk factor progression and the occurrence of future vascular events were estimated using the United Kingdom Prospective Diabetes Study @ risk equations .


Costs and utilities were derived from the literature .


The analysis was conducted from the societal perspective , simulating the remaining lifetime of the patients .


The overall incidence of macro - and microvascular complications was lower , and life expectancy was greater ( @ versus @ life-years -LSB- LYs -RSB- ) in patients receiving dapagliflozin than in those not receiving dapagliflozin .


Patients in the dapagliflozin arm obtained an incremental benefit of @ quality-adjusted life-years ( QALYs ) .


The lifetime incremental cost per patient in the dapagliflozin arm was @,@ , resulting in an incremental cost-effectiveness ratio of @,@ per LY gained and an incremental cost-utility ratio of @,@ per QALY gained .


Sensitivity and scenario analyses showed that the results were insensitive to variations in modelling assumptions and input variables .


Dapagliflozin in combination with insulin was estimated to be a cost-effective treatment option for patients with T@DM whose insulin treatment regimen does not provide adequate glycaemic control in a Dutch healthcare setting .


The objective of our study was to use proton MR spectroscopy ( MRS ) to quantitatively evaluate bone marrow infiltration by measuring the fat fraction ( FF ) and to compare the FF with semiquantitative bone marrow MRI scores and clinical status in children treated for type @ Gaucher disease ( GD ) .


Over a @-year period , we prospectively evaluated @ treated GD patients ( six males , four females ; median age , @ years ) and @ healthy age-matched control subjects ( five males , five females ; median age , @ years ) using @-T proton MRS of L@ and the femoral neck .


Water and lipid AUCs were measured to calculate the FF .


Two blinded pediatric musculoskeletal radiologists performed a semiquantitative analysis of the conventional MR images using the bone marrow burden score and modified Spanish MRI score .


We evaluated symptoms , spleen and liver volumes , platelet levels , hemoglobin levels , and bone complications .


In the femur , the FF was higher in the control subjects ( median , @ ) than the GD patients ( @ ) ( p = @ ) .


In L@ , the difference in FF -- higher FF in control subjects ( @ ) than in GD patients ( @ ) -- was not significant ( p = @ ) .


In both groups and both regions , the FF increased with patient age ( p < @ ) .


Semiquantitative scores showed no differences between control subjects and treated GD patients ( p > @ ) .


Eight of @ GD patients were asymptomatic and two had chronic bone pain .


The median age of patients at symptom onset was @ years , the median age of patients at the initiation of enzyme replacement therapy was @ years , and the median treatment duration was @ years .


Hemoglobin level , platelet count , and liver volume at MRI were normal .


Mean pretreatment spleen volume ( @-fold above normal ) decreased to @-fold above normal at the time of MRI ( p = @ ) .


Proton MRS detected FF differences that were undetectable using conventional MRI ; for that reason , proton MRS can be used to optimize treatment of GD patients .


Proper bioequivalence studies comparing original with generic immunosuppressive drugs in patients are limited , especially in the increasing population of elderly renal transplant recipients .


We performed an open-label , single-center , prospective , randomized , cross-over study and compared steady-state pharmacokinetics ( PK ) of a generic tacrolimus ( Tacni ) formulation with the original ( Prograf ) in renal transplant recipients older than @ years .


Twenty-eight patients , with a median age of @ years ( range , @ to @ ) , were randomized at time of transplantation to receive original or generic tacrolimus , and @ ( @ men , @ women ) provided two evaluable @-hr PK profiles .


The PK investigations were performed in a stable phase approximately @ and @ weeks postengraftment .


After the first PK investigation , tacrolimus formulations were switched ( @:@ dose ratio ) .


Generic tacrolimus did not meet the bioequivalence criteria ; the area under the curve ( @-@ ) ratio of generic-original tacrolimus formulation was @ ( @ % confidence interval , @-@ @ ) and the Cmax ratio was @ ( @ % confidence interval , @-@ @ ) .


The generic formulation also showed a shorter time to C ( max ) ( T ( max ) ) ( P = @ ) .


Importantly , the lack of bioequivalence was not reflected in the standard monitoring parameter , trough concentrations ( P = @ ) .


Generic tacrolimus ( Tacni ) was not found to be bioequivalent to the original formulation in elderly renal transplant recipients .


The significantly higher systemic exposure of tacrolimus , despite similar trough concentrations , may in the long run increase the risk of adverse effects .


Autoimmune rheumatic diseases ( ARD ) are characterized by systemic inflammation and may affect multiple organs and cause vascular events such as ischemic stroke and acute myocardial infarction .


However , the association between ARD and increased risk of dementia is uncertain .


This is a retrospective cohort study to investigate and compare the risk of dementia between patients clinically diagnosed with ARD and non-ARD patients during a @-year follow-up period .


Data were obtained from the Longitudinal Health Insurance Database @ ( LHID@ ) .


We included @ patients receiving ambulatory or hospitalization care and @ non-ARD patients ; patients were matched by sex , age , and the year of index use of health care .


Each patient was studied for @ years to identify the subsequent manifestation of dementia .


The data obtained were analyzed by Cox proportional hazard regression .


During the @-year follow-up period , @ ARD ( @ % ) and @ non-ARD patients ( @ % ) developed dementia .


During the @-year follow-up period , there were no significant differences in the risks of any type of dementia ( adjusted hazard ratio ( HR ) , @ ; @ % CI , @-@ @ ) in the ARD group after adjusting for demographics and comorbidities .


Within the @-year period , patients with and without ARD were found to have similar risks of developing dementia .


The high consumption of low-fat and nonfat dairy products is associated with reduced risk of high blood pressure .


We aimed to investigate whether the solitary addition of nonfat dairy products to the normal routine diet was capable of lowering blood pressure in middle-aged and older adults with elevated blood pressure .


With the use of a randomized , crossover intervention-study design , @ adults ( @ % women ) with elevated blood pressure ( mean SEM age : @ @ y ; systolic blood pressure : @ @ ; diastolic blood pressure : @ @ mm Hg ) underwent a high-dairy condition ( +@ servings conventional nonfat dairy products/d ) and isocaloric no-dairy condition ( +@ servings fruit products/d ) in which all dairy products were removed .


Both dietary conditions lasted @ wk with a @-wk washout before crossing over into the alternate condition .


The high-dairy condition produced reductions in systolic blood pressure ( @ @ to @ @ mm Hg ) and pulse pressure ( @ @ to @ @ mm Hg ) ( both P < @ ) .


The hypotensive effects were observed within @ wk after the initiation of the dietary intervention and in both casual seated and ambulatory ( @-h ) measurements ( P < @ ) .


Pulse pressure was increased after the removal of all dairy products in the no-dairy condition ( @ @ to @ @ mm Hg ; P < @ ) .


There were no changes in diastolic blood pressure after either dietary condition .


We concluded that the solitary manipulation of conventional dairy products in the normal routine diet would modulate blood pressure in middle-aged and older adults with prehypertension and hypertension .


This trial was registered at clinicaltrials.gov as NCT@ .


Potent antibody depletion techniques have paved the way to successful ABO-incompatible transplantation .


Considering its efficiency regarding IgG removal , the use of non-antigen-specific semi-selective immunoadsorption ( IA ) has been advocated .


One attractive strategy to overcome the caveat of incomplete IgM depletion and to interfere with complement activation could be the adjunctive use of membrane filtration ( MF ) to enhance the removal of macromolecules .


To investigate the depletion efficiency of semi-selective IA plus MF , we conducted a randomized , controlled , cross-over trial including patients on regular IA treatment for indications outside recipient desensitization .


According to the results of sample size calculation , @ subjects were enrolled .


Two treatment sequences , a single session of IA plus MF followed by IA alone after @ days ( and vice versa ) , were analysed .


IA plus MF markedly enhanced the median per cent reduction of ABO-specific IgM determined by flow cytometry ( primary end point ; @ versus @ % , P < @ ) and haemagglutination ( @ versus @ titre steps , P < @ ) , respectively .


Combined treatment also substantially lowered C@q concentrations ( @ versus @ % reduction , P < @ ) and the functionality of classical complement as reflected by impaired in vitro C@ activation capability .


IgG was strongly reduced without any additional effect of MF .


We demonstrate that the innovative strategy of combining MF with semi-selective IA may substantially increase IgM elimination and affect classical complement activation .


Our findings suggest that this new treatment concept could be an efficient strategy for recipient desensitization in ABO - and HLA-incompatible transplantation .


This study examined the effect of brief functional relaxation ( FR ) training on needle anxiety ( NA ) during vaccinations .


From October @ through May @ , @ undergraduates were recruited through the psychology research participant pool .


Students ( N = @ ) were randomly assigned to a @-minute brief FR session delivered via MP@ player or a standard care condition ( @ minutes of sitting quietly ) prior to receiving injections at the immunization clinic .


Measures were completed before ( T@ ) and after ( T@ ) the assigned condition , assessing expected NA , state anxiety , blood pressure , and heart rate ; and after the injection ( T@ ) , self-reported NA during the injection .


Unexpectedly , the groups did not differ at T@ .


However , during the injection , brief FR participants indicated lower self-reported NA ( T@ ) than standard care .


Brief FR is a simple , inexpensive technique that may reduce NA in college health settings and help decrease delays in treatment seeking .


Little is known about the relationship between body temperature and outcomes in patients with acute respiratory distress syndrome ( ARDS ) .


A better understanding of this relationship may provide evidence for fever suppression or warming interventions , which are commonly applied in practice .


To examine the relationship between body temperature and mortality in patients with ARDS .


Secondary analysis of body temperature and mortality using data from the ARDS Network Fluid and Catheter Treatment Trial ( n = @ ) .


Body temperature at baseline and on study day @ , primary cause of ARDS , severity of illness , and @-day mortality were analyzed by using multiple logistic regression .


Mean baseline temperature was @ C ( SD , @ C ; range , @C-@ @ C ) .


At baseline , fever ( @ C ) was present in @ % and hypothermia ( < @C ) in @ % of the patients .


Body temperature was a significant predictor of @-day mortality after primary cause of ARDS and score on the Acute Physiology and Chronic Health Evaluation III were adjusted for .


Higher temperature was associated with decreased mortality : for every @C increase in baseline temperature , the odds of death decreased by @ % ( odds ratio , @ ; @ % CI , @-@ @ , P = @ ) .


When patients were divided into @ temperature groups , mortality was lower with higher temperature ( P for trend = @ ) .


Early in ARDS , fever is associated with improved survival rates .


Fever in the acute phase response to lung injury and its relationship to recovery may be an important factor in determining patients ' outcome and warrants further study .


Endoscopic examinations carry a potential risk of cross-infection , and the traditional reprocessing method is time consuming .


We evaluated the safety and efficacy of a novel disposable sheathed gastroscope system in clinical practice in comparison with the conventional gastroscope .


There were two phases in the study .


In phase @ , @ patients with hepatitis B were randomized into two groups : the sheathed group was examined with the novel disposable sheathed gastroscope ( n = @ ) and the conventional group with the conventional gastroscope ( n = @ ) .


Microbiologic tests were performed on each endoscope afterwards .


In the second phase , @ patients were randomized again into the same two groups with @ and @ patients in the sheathed group and the conventional group , respectively .


The time duration of the endoscopic procedure and reprocessing were measured .


The pathology detection rate of endoscopic examinations , the patients ' subjective feelings , and problems occurred during procedures were also recorded .


The total instrument turn-around time in the phase @ sheathed group ( @ @ min ) was significantly shorter than the conventional group ( @ @ min , P = @ ) .


The mean procedural time was slightly longer in the sheathed group than in the conventional group ( @ @ vs @ @ min , P = @ ) .


However , the duration of endoscopic reprocessing was much shorter ( @ @ vs @ @ min , P = @ ) .


No significant differences were observed in patient discomfort , optical clarity , or pathology detection rate .


There were no complications in either group , and no microbial contamination was detected in phase @ of the study .


Compared with the conventional gastroscope , the novel disposable sheathed gastroendoscope is safe and more efficient in clinical practice .


To evaluate the outcome of the non-skin thinning technique as compared with the thinning technique @ years after surgical implantation of bone-anchored hearing `` devices . ''


A single-center , @-year retrospective follow-up study was designed to evaluate the novel surgical technique without skin thinning as compared to conventional techniques .


Eligible patients were consecutively operated on @ years earlier in a test group without thinning and in two control groups with thinning .


In the first control group , a flap technique was used , whereas in the second control group a dermatome technique was used and age-matched patients were selected .


Thirty-six patients were operated on with a single-step surgery under local anesthesia .


In the test group ( non-skin thinning technique ) , @ patients were operated on with a linear incision using an @-mm abutment .


In the control groups ( flap and dermatome techniques , @ patients in each group ) , the standard protocol with skin thinning was used with a @-mm abutment .


Throughout the @-year span under review , the non-skin thinning test group exhibited good preservation of tissue with decreased skin reactions and no adverse events .


The time required for surgery without skin thinning was reduced to approximately @ to @ minutes and the cosmetic outcome after @ years was improved .


Numbness and peri-implant infections were minimal in the surrounding skin area for patients who underwent surgery without thinning .


This @-year follow-up study demonstrates that percutaneous osseointegrated implantation without skin thinning is safe and has a better outcome than implantation with skin thinning .


The two primary residential options for older adults who require supportive care are nursing homes and residential care/assisted living .


More than one-quarter of all deaths in the U.S. occur in these settings .


Although the information available on end of life in long-term care has been growing , the comparative suitability of various measures to guide this work is unknown .


To determine the optimal measures to assess end-of-life care and outcomes in nursing homes and residential care/assisted living .


A total of @ family members of decedents from @ settings were interviewed and provided data on @ instruments that have been used in , but not necessarily developed for , long-term care populations ; Overall , @ scales and subscales/indices were evaluated .


Measures were compared on their psychometric properties and the extent to which they discriminated among important resident , family , and setting characteristics .


Prioritizing measures that distinguish the assessment of care from the assessment of dying , and secondarily thatexhibit an acceptable factor structure , this study recommends two measures of care-the Family Perceptions of Physician-Family Caregiver Communication and the End of Life in Dementia ( EOLD ) - Satisfaction With Care-and two measures of outcomes-the EOLD-Symptom Management and the EOLD-Comfort Assessment in Dying .


An additional measure to assess outcomes is the Mini-Suffering State Examination ( MSSE ) .


The care measures and the MSSE are especially valuable as they discriminate between decedents who were and were not transferred immediately before death , an important outcome , and whether the family expected the death , a useful target for intervention .


Despite these recommendations , measurement selection should be informed not only on the basis of psychometric properties but also by specific clinical and research needs .


The data in this manuscript will help researchers , clinicians , and administrators understand the implications of choosing various measures for their work .


To explore the effect of Tongfu Jinghua Decoction ( TJD ) on hemodynamics and tissue oxygen metabolism in patients with post-traumatic sepsis shock .


Totally @ patients were randomly assigned to the treatment group and the control group , @ in each group .


Patients in the treatment group took TJD or were administered with TJD by nasal feeding in combined with conventional Western medical treatment , while patients in the control group only received conventional Western medical treatment .


Changes of each index in hemodynamics and tissue oxygen metabolism were observed before treatment , and at @ , @ , @ , and @ h after treatment .


Compared with before treatment in the same group , hemodynamic changes were significantly improved at each time point in the two groups .


All indices of tissue oxygen metabolism at each time point of the two groups were significantly improved , except changes of O@ extraction ratio ( ER ) after treatment in the control group ( P < @ , P < @ ) .


Compared with the control group in the same period , heart rate ( HR ) , systemic vascular resist - ance ( SVR ) , and cardiac output ( CO ) were significantly improved with statistical difference ( P < @ , P < @ ) .


Mean arterial pressure ( MAP ) , central venous pressure ( CVP ) , and cardiac index ( CI ) were significantly improved at @ , @ , and @ h after treatment with statistical difference ( P < @ , P < @ ) .


Each index of tissue oxygen metabolism in the treatment group were all improved at each time point with statistical difference ( P < @ , P < @ ) .


TJD combined with conventional Western medical treatment could quickly improve hemodynamics and tissue oxygen metabolism disorder in patients with septic shock , and its curative effect was superior to that of conventional Western medical treatment alone .


In the Total Body Hypothermia for Neonatal Encephalopathy Trial ( TOBY ) , newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at @ months of age , but it is uncertain whether such therapy results in longer-term neurocognitive benefits .


We randomly assigned @ newborns with asphyxial encephalopathy who were born at a gestational age of @ weeks or more to receive standard care alone ( control ) or standard care with hypothermia to a rectal temperature of @ to @C for @ hours within @ hours after birth .


We evaluated the neurocognitive function of these children at @ to @ years of age .


The primary outcome of this analysis was the frequency of survival with an IQ score of @ or higher .


A total of @ of @ children ( @ % ) in the hypothermia group versus @ of @ ( @ % ) in the control group survived with an IQ score of @ or more ( relative risk , @ ; P = @ ) .


The proportions of children who died were similar in the hypothermia group and the control group ( @ % and @ % , respectively ) .


More children in the hypothermia group than in the control group survived without neurologic abnormalities ( @ of @ -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- ; relative risk , @ ; @ % confidence interval , @ to @ ) .


Among survivors , children in the hypothermia group , as compared with those in the control group , had significant reductions in the risk of cerebral palsy ( @ % vs. @ % , P = @ ) and the risk of moderate or severe disability ( @ % vs. @ % , P = @ ) ; they also had significantly better motor-function scores .


There was no significant between-group difference in parental assessments of children 's health status and in results on @ of @ psychometric tests .


Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes in middle childhood .


( Funded by the United Kingdom Medical Research Council and others ; TOBY ClinicalTrials.gov number , NCT@ . )


To evaluate the effectiveness and safety of @ % sodium hyaluronate ( HA ) compared to recombinant bovine basic fibroblast growth factor ( rb-bFGF ) for the treatment of corneal epithelial abrasion caused by mechanical damage in Chinese patients .


Thirty patients were randomly assigned to the HA or rb-bFGF treatment group .


The HA group was treated with @ % HA and @ % levofloxacin , and the rb-bFGF group was treated with topical rb-bFGF and @ % levofloxacin .


The primary endpoint was the clinical effectiveness rates at day @ .


Secondary endpoints were the dimensions of the wound area and the percentage of wound closure .


After @ days of treatment , the clinical effectiveness rates of the HA group and the rb-bFGF group were @ % ( @/@ ) and @ % ( @/@ ) , respectively .


The dimensions of the wound area were reduced from @ to @ mm ( @ ) for the HA group at day @ , and from @ to @ mm ( @ ) for the rb-bFGF group .


At day @ , the wound closure was almost complete in both groups ; @ % in the HA group compared to @ % in the rb-bFGF group ( P > @ ) .


Topical @ % HA provided a promising treatment for superficial corneal abrasion caused by mechanical damage in a manner similar to rb-bFGF .


To identify the determinants of recurrence following primary pterygium excision combined with conjunctival autograft ( CAG ) and intraoperative use of Mitomycin C ( MMC ) or @-Fluorouracil ( @-FU ) .


A randomized controlled clinical trial comparing @-FU ( @ mg/ml ) plus CAG versus MMC ( @ % ) plus CAG in preventing recurrence of primary pterygium following excision .


A total of @ eyes of @ subjects were studied , with @ eyes in the @-FU group and @ eyes in the MMC group .


The mean age was @ + / - @ years with a male : female ratio of @:@ .


Mean follow up period was @ + / - @ weeks .


The overall recurrence rate was @ % , with a rate of @ % in the @-FU group and @ % in the MMC group .


The mean age of the patients who had a recurrence was @ + / - @ years compared to @ + / - @ years in those without a recurrence ( p = @ ) .


The median size of the pterygium in patients who had a recurrence was @ mm , while the median size in patients who did not have a recurrence was @ mm ( p = @ ) .


Five ( @ % ) males had a recurrence compared to three ( @ % ) females ( p = @ ) ; while @ % of fleshy pterygia recurred compared to none ( @ % ) of the non-fleshy pterygia ( p = @ ) .


Younger age remains a risk factor for recurrence when both CAG and antimetabolites are combined in the treatment of pterygium , while the effect of gender , size and morphology of the pterygium may be diminished by such combination .


The optimal platelet inhibition strategy for ACS patients managed without revascularization is unknown .


We aimed to evaluate efficacy and safety of ticagrelor vs. clopidogrel in the non-ST-elevation acute coronary syndrome ( NSTE-ACS ) subgroup of the PLATO trial , in the total cohort , and in the subgroups managed with and without revascularization within @ days of randomization .


We performed a retrospective analysis of the primary endpoint of cardiovascular death/myocardial infarction/stroke .


Among @ @ PLATO patients , @ @ ( @ % ) were categorized as NSTE-ACS at randomization .


During the initial @ days , @ % had angiography , @ % PCI , and @ % CABG .


In NSTE-ACS patients , the primary endpoint was reduced with ticagrelor vs. clopidogrel -LSB- @ vs. @ % ; hazard ratio ( HR ) @ ; @ % confidence interval ( CI ) = @-@ @ -RSB- , as was myocardial infarction ( @ vs. @ % ; HR @ ; @ % CI = @-@ @ ) , cardiovascular death ( @ vs. @ % ; HR @ ; @ % CI = @-@ @ ) , and all-cause death ( @ vs. @ % ; HR @ ; @ % CI = @-@ @ ) .


Major bleeding rate was similar between treatment groups ( @ vs. @ % ; HR @ ; @ % CI = @-@ @ ) , but ticagrelor was associated with an increase in non-CABG major bleeding ( @ vs. @ % ; HR @ ; @ % CI = @-@ @ ) .


Within the first @ days , @ ( @ % ) patients were managed without revascularization .


Regardless of revascularization or not , ticagrelor consistently reduced the primary outcome ( HR @ vs. @ , interaction P = @ ) , and all-cause death ( HR @ vs. @ , interaction P = @ ) with no significant increase in overall major bleeding .


In patients with NSTE-ACS , benefit of ticagrelor over clopidogrel in reducing ischaemic events and total mortality was consistent with the overall PLATO trial , independent of actually performed revascularization during the initial @ days .


Declining of eradication rates for Helicobacter pylori in Korea may be partly from the increasing prevalence of antibiotic resistance , especially clarithromycin resistance .


To compare the efficacy and the safety of using @-day standard sequential therapy and levofloxacin-containing sequential therapy as a first-line treatment for Helicobacter pylori eradication in Korea .


A total of @ patients with proven Helicobacter pylori infection randomly received @-day standard sequential therapy ( n = @ ) or levofloxacin-containing sequential therapy ( n = @ ) .


The standard sequential therapy group received rabeprazole and amoxicillin for @ days , followed by rabeprazole , clarithromycin , and metronidazole for @ more days .


The levofloxacin-containing sequential therapy group was treated with rabeprazole and amoxicillin for @ days , followed by rabeprazole , levofloxacin , and metronidazole for @ more days .


Intention-to-treat eradication rates were @ % and @ % for groups of standard sequential and levofloxacin-containing sequential therapy , respectively ( P = @ ) .


Per-protocol eradication rates were @ % and @ % , respectively , for these two therapies ( P = @ ) .


There were no significant differences between the groups in regard to the eradication rates and adverse events .


The @-day levofloxacin-containing sequential regimen and the standard sequential regimen showed the similar eradication rates of Helicobacter pylori in Korea .


We investigated whether individualized positive end-expiratory pressure ( PEEP ) improves oxygenation , ventilation , and lung mechanics during one-lung ventilation compared with standardized PEEP .


Thirty patients undergoing thoracic surgery were randomly allocated to the study or control group .


Both groups received an alveolar recruitment maneuver at the beginning and end of one-lung ventilation .


After the alveolar recruitment maneuver , the control group had their lungs ventilated with a @ cmH@O PEEP , while the study group had their lungs ventilated with an individualized PEEP level determined by a PEEP decrement trial .


Arterial blood samples , lung mechanics , and volumetric capnography were recorded at multiple timepoints throughout the procedure .


The individualized PEEP values in study group were higher than the standardized PEEP values ( @ @ vs @ cmH@O ; P < @ ) .


In both groups , arterial oxygenation decreased when bilateral-lung ventilation was switched to one-lung ventilation and increased after the alveolar recruitment maneuver .


During one-lung ventilation , oxygenation was maintained in the study group but decreased in the control group .


After one-lung ventilation , arterial oxygenation was significantly higher in the study group ( @ vs @ mmHg , P = @ ) .


Static compliance decreased in both groups when bilateral-lung ventilation was switched to one-lung ventilation .


Static compliance increased significantly only in the study group ( P < @ ) after the alveolar recruitment maneuver and optimal PEEP adjustment .


The alveolar recruitment maneuver did not decrease cardiac index in any patient .


During one-lung ventilation , the improvements in oxygenation and lung mechanics after an alveolar recruitment maneuver were better preserved by ventilation by using individualized PEEP with a PEEP decrement trial than with a standardized @ cmH@O of PEEP .


Alzheimer 's disease , a global public health issue , accounts for @ to @ % of all dementias .


Alzheimer 's disease primarily causes cognitive impairment and drugs have only modest short-term effects , highlighting a pressing need to develop effective interventions .


Aerobic exercise holds promise for treating cognitive impairment in Alzheimer 's disease through biologically sound mechanisms .


Nonetheless , aerobic exercise studies in Alzheimer 's disease are limited with mixed findings .


This pilot randomized controlled trial will investigate the effects of a @-month , individualized , moderate-intensity cycling intervention ( @ to @ minutes per session , @ times a week ) on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate Alzheimer 's disease .


The specific aims are to : @ ) determine the immediate effect of the cycling intervention on cognition in Alzheimer 's disease ; @ ) examine if the cycling intervention slows cognitive decline in Alzheimer 's disease from baseline to @ months ; and @ ) assess the effect of aerobic exercise on hippocampal volume over @ months .


Ninety subjects will be randomized on a @:@ allocation ratio to cycling or attention control ( low-intensity stretching ) and followed for another @ months .


Allocations will be concealed to all investigators and outcome assessors will be blinded to group assignments and previous data .


Cognition will be measured by the Alzheimer 's disease Assessment Scale-Cognition at baseline before randomization and at @ , @ , @ , and @ months .


Hippocampal volume will be measured by magnetic resonance imaging at baseline and @ and @ months .


The sample size of @ will give @ % power to detect a @-point difference in within-group changes in the Alzheimer 's disease Assessment Scale-Cognition at @ months for the cycling group .


Findings from this study will address the critical gap of exercise efficacy in Alzheimer 's disease and use of magnetic resonance imaging as an outcome measure in clinical trials .


This study will provide a potential treatment that may increase physical function and quality of life and curb the prohibitive costs for the growing dementia population .


To observe the primary prevention role of Wuling Capsule ( WC ) on poststroke depression ( PSD ) patients .


Acute stroke patients were recruited and randomized into @ groups by stratification , @ in each group .


All patients received same routine treatment of cardiovascular diseases .


Patients in the experimental group additionally took WC ( @ g each pill ) , @ pills per day , three times per day ; while those in the control group additionally took placebos , @ pills per day , three times per day .


Two weeks consisted of one therapeutic course .


The diagnosis of PSD was performed once every other week .


Those in accordance with PSD diagnosis discontinued any drug therapy .


Those not in accordance with PSD diagnosis continued the drug therapy for @-@ therapeutic course ( s ) ( in total of @ months ) .


If they were still not in accordance with PSD diagnosis , then they discontinued the drug therapy .


The morbidity of PSD , the average time of depression occurrence , Hamilton depression rating scale ( HAMD ) score , and adverse reactions were observed .


The @ - , @ - , and @-month morbidity of PSD was @ % , @ % , and @ % in the experimental group , while they were @ % , @ % , and @ % in the control group .


The occurrence rate was lower in the experimental group than in the control group .


Besides , there was statistical difference in the @-month occurrence rate between the two groups ( chi@ = @ , P < @ ) .


The average time of PSD occurrence was longer in the experimental group than in the control group ( @ + / - @ weeks vs. @ + / - @ weeks ; t = @ , P < @ ) .


The HAMD score at the PSD occurrence was @ + / - @ in the experimental group , lower than that of the control group ( @ + / - @ ) , showing statistical difference ( t = @ , P < @ ) .


WC was superior to the placebos in lowering the incidence of PSD , delaying the occurrence time of PSD , attenuating the depression degree of PSD , and had certain preventive effect on the incidence of PSD .


Collective caregiving , performed by caregivers working in pairs ( informal primary and secondary caregivers working together ) , is common in the hospice setting .


Research suggests that caregiving pairs may experience different caregiver outcomes .


However , little is known about how caregiving pairs differ from solo caregivers ( informal primary caregivers ) on outcome measures .


The goal of this study was to determine whether being in a caregiver pair affected caregiver anxiety and depression and how outcomes changed over time .


A mixed model analysis was used .


Hospice caregivers ( @ solo caregivers and @ caregivers in @ pairs ) who participated in a larger , randomized controlled trial completed caregiver measures upon hospice admission and periodically until the death of the patient or hospice decertification .


Measured were caregiver quality of life , social support , anxiety , and depression .


Caregiver pairs had higher anxiety and depression scores than solo caregivers .


Emotional , financial , and physical quality of life were associated with decreased depression , whereas only emotional and financial quality of life were correlated with lower levels of anxiety .


Social support was associated with lower levels of depression and anxiety .


Despite assumptions that social support is positively facilitated vis-a-vis collective caregiving , caregiving pairs may be at higher risk for anxiety and depression .


Future research is needed to address why individuals become anxious and/or depressed when working as part of a caregiving pair .


Delayed antibiotic prescribing is an effective method of reducing the consumption of antibiotics for respiratory tract infections ( RTIs ) .


However , interventions to promote its use remain unexplored .


To measure the effects of a GP educational intervention and a computer delayed-prescribing pop-up reminder on antibiotic-dispensing rates .


The study also aimed to identify factors influencing GPs ' decisions to issue delayed prescriptions and patients ' decisions to fill their prescriptions .


Controlled trial nested within a cluster-randomised controlled trial in urban and rural practices in @ counties in southern Norway .


Educational intervention and control groups were randomly populated from @ continuing medical education groups .


Within the intervention arm , @ of the @ participating GPs were assigned , based on the electronic patient-record system they used , to having a pop-up reminder installed on their computers .


Data on prescribed and dispensed antibiotics from @ year before , and @ year during , the intervention were collected and linked .


Valid data were obtained from @ GPs ( @ % ) .


At baseline , @ % of prescriptions were filled at pharmacies .


The effect of the educational intervention was a @ % reduction in approximated risk ( risk ratio -LSB- RR -RSB- @ , @ % confidence interval -LSB- CI -RSB- = @ to @ ) of antibiotics being dispensed , while the combined effect of the educational and pop-up reminder intervention was a @ % reduction in approximated risk ( RR @ , @ % CI = @ to @ ) .


In the pop-up intervention group , @ % of the prescriptions were issued as delayed prescriptions and @ % of these were filled .


Upper RTI , sinusitis , and otitis gave highest odds for delayed prescribing and lowest odds for dispensing .


Promoting delayed prescribing among GPs results in a small decrease in antibiotic dispensing .


The savings potential is greatest for upper RTI , sinusitis , and otitis .


To study eye movements in a large group of children after the removal of unilateral infantile cataract , and to compare fixation instabilities between treatment groups with or without IOL implantation .


The Infant Aphakia Treatment Study ( IATS ) is a randomized , multicenter clinical trial comparing IOL to contact lens ( CL ) treatment with a unilateral infantile cataract in participants who underwent cataract surgery at @ to @ months of age .


At age @ years , eye movements were recorded in @ participants , using a high-speed video camera while the child performed a fixation task .


The recordings were inspected by masked readers for the presence of fixation instabilities ( nystagmus and saccadic oscillations ) .


Overall , fixation instabilities were observed in @ ( @ % ) of @ children who had evaluable recordings , with no differences between treatment groups ( @ -LSB- @ % -RSB- of @ in the IOL group , @ -LSB- @ % -RSB- of @ in the CL group ; P = @ ) .


Nystagmus was seen in @ % and saccadic oscillations in @ % , with no differences between treatment groups ( P > @ ) .


Children without a fixation instability had better visual acuity ( P = @ ) .


Nystagmus and saccadic oscillations are well-known consequences of infantile cataracts , presumably the result of visual deprivation during the critical period of visual development .


After early cataract extraction , successful optical correction may reduce further form deprivation and minimize the incidence of these fixation instabilities .


In this study , no differences in the presence of fixation instabilities were found between the two treatment strategies ( CL or IOL ) for optical correction after cataract removal .


( ClinicalTrials.gov number , NCT@ . )


This report presents the analysis of the RTOG @ multicenter randomized study that compared acupuncture-like transcutaneous stimulation ( ALTENS ) with pilocarpine ( PC ) for relieving radiation-induced xerostomia .


Eligible patients were randomized to twice-weekly @-minute ALTENS sessions for @ sessions during @weeks or PC ( @mg @ times daily for @weeks ) .


The primary endpoint was the change in the University of Michigan Xerostomia-Related Quality of Life Scale ( XeQOLS ) scores from baseline to @months from randomization ( MFR ) .


Secondary endpoints included basal and citric acid primed whole salivary production ( WSP ) , ratios of positive responders ( defined as patients with @ % reduction in overall radiation-induced xerostomia symptom burden ) , and the presence of adverse events based on the Common Terminology Criteria for Adverse Events version @ .


An intention-to-treat analysis was conducted .


One hundred forty-eight patients were randomized .


Only @ patients completed the required XeQOLS and were evaluable at @ MFR ( representing merely @ % statistical power ) .


Seventy-six patients were evaluable at @ MFR .


The median change in the overall XeQOLS in ALTENS and PC groups at @ and @ MFR were -@ and -@ ( P = @ ) and -@ and -@ ( P = @ ) .


The corresponding percentages of positive responders were @ % and @ % ( P = @ ) and @ % and @ % ( P = @ ) .


Changes in WSP were not significantly different between the groups .


Grade @ or less adverse events , mostly consisting of grade @ , developed in @ % of patients in the ALTENS group and in @ % of the PC group .


The observed effect size was smaller than hypothesized , and statistical power was limited because only @ of the recruited @ patients were evaluable .


The primary endpoint-the change in radiation-induced xerostomia symptom burden at @ MFR-was not significantly different between the ALTENS and PC groups .


There was significantly less toxicity in patients receiving ALTENS .


Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy ( TH ) and stapled haemorrhoidopexy ( SH ) surgery .


However , uncertainty remains as to how they compare from a clinical , quality of life ( QoL ) and economic perspective .


The study is therefore designed to determine whether SH is more effective and more cost-effective , compared with TH .


eTHoS ( either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease ) is a pragmatic , multicentre , randomised controlled trial .


Currently , @ secondary care centres are open to recruitment .


Patients , aged @ year or older , with circumferential haemorrhoids grade II to IV , are eligible to take part .


The primary clinical and economic outcomes are QoL profile ( area under the curve derived from the EuroQol Group 's @ Dimension Health Status Questionnaire ( EQ-@D ) at all assessment points ) and incremental cost per quality adjusted life year ( QALY ) based on the responses to the EQ-@D at @ months .


The secondary outcomes include a comparison of the SF-@ scores , pain and symptoms sub-domains , disease recurrence , complication rates and direct and indirect costs to the National Health Service ( NHS ) .


A sample size of n = @ per group has been calculated to provide @ % power to detect a difference in the mean area under the curve ( AUC ) of @ standard deviations derived from EQ-@D score measurements , with a two-sided significance level of @ % .


Allowing for non-response , @ participants will be randomised per group .


Randomisation will utilise a minimisation algorithm that incorporates centre , grade of haemorrhoidal disease , baseline EQ-@D score and gender .


Blinding of participants and outcome assessors is not attempted .


This is one of the largest trials of its kind .


In the United Kingdom alone , @,@ operations for haemorrhoidal disease are done annually .


The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions and , more importantly , patients can make informed choices .


The aim of the study was to assess the impact of the long-term use of the composite probiotics in patients after restorative proctocolectomy .


Forty-three patients ( @ females and @ males , aged @ to @ years ) after restorative proctocolectomy were included in the study .


After randomization patients were divided into placebo group and treatment group with oral intake of probiotic containing Lactobacillus acidophilus , Lactobacillus delbrueckii subsp .


bulgaricus , and Bifidobacterium bifidus .


Patients were investigated during initial visit and during final visit after @ months .


All patients were subjected to standard clinical and endoscopic examination with microscopic study of the specimens .


Concentrations of calprotectin and pyruvate kinase isoenzyme M@-PK were determined in all cases .


The average severity of pouchitis and the number of patients with pouchitis significantly decrease after @ months of the probiotic taking .


The concentrations of calprotectin and pyruvate kinase isoenzyme M@-PK significantly decreased after the therapy .


Nine months of the probiotic treatment ( Lactobacillus acidophilus , Lactobacillus delbrueckii subsp .


bulgaricus , and Bifidobacterium bifidus ) reduced the number of patients with pouchitis , decreased the PDAI score , and also decreased the fecal pyruvate kinase and calprotectin .


The long-term probiotics use is safe and well accepted and can be an effective method of the pouchitis prevention .


To compare the efficacy and safety of two doses of once-weekly dulaglutide , a glucagon-like peptide @ receptor agonist , to sitagliptin in uncontrolled , metformin-treated patients with type @ diabetes .


The primary objective was to compare ( for noninferiority and then superiority ) dulaglutide @ mg versus sitagliptin in change from baseline in glycosylated hemoglobin A@c ( HbA@c ) at @ weeks .


This multicenter , adaptive , double-blind , parallel-arm study randomized patients ( N = @,@ ; mean baseline age @ years ; HbA@c @ % -LSB- @ mmol/mol -RSB- ; weight @ kg ; diabetes duration @ years ) to dulaglutide @ mg , dulaglutide @ mg , sitagliptin @ mg , or placebo ( placebo-controlled period up to @ weeks ) .


The treatment period lasted @ weeks , with @-week primary end point data presented .


The mean HbA@c changes to @ weeks were ( least squares mean SE ) : -@ @ % ( -@ @ mmol/mol ) , -@ @ % ( @ @ mmol/mol ) , and -@ @ % ( @ @ mmol/mol ) for dulaglutide @ mg , dulaglutide @ mg , and sitagliptin , respectively .


Both dulaglutide doses were superior to sitagliptin ( P < @ , both comparisons ) .


No events of severe hypoglycemia were reported .


Mean weight changes to @ weeks were greater with dulaglutide @ mg ( -@ @ kg ) and dulaglutide @ mg ( -@ @ kg ) compared with sitagliptin ( -@ @ kg ) ( P < @ , both comparisons ) .


The most common gastrointestinal treatment-emergent adverse events in dulaglutide @ - and @-mg arms were nausea , diarrhea , and vomiting .


Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at @ weeks with an acceptable tolerability and safety profile .


Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first @ years of follow-up .


We report the long-term follow-up of the IBIS-I trial , in which the participants and investigators remain largely masked to treatment allocation .


In the IBIS-I randomised controlled trial , premenopausal and postmenopausal women @-@ years of age deemed to be at an increased risk of developing breast cancer were randomly assigned ( @:@ ) to receive oral tamoxifen @ mg daily or matching placebo for @ years .


Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule ( permuted block sizes of six or ten ) .


Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply .


The primary endpoint was the occurrence of breast cancer ( invasive breast cancer and ductal carcinoma in situ ) , analysed by intention to treat .


Cox proportional hazard models were used to assess breast cancer occurrence and mortality .


The trial is closed to recruitment and active treatment is completed , but long-term follow-up is ongoing .


This trial is registered with controlledtrials.com , number ISRCTN@ .


Between April @ , @ , and March @ , @ , @ eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups : @ to tamoxifen and @ to placebo .


After a median follow up of @ years ( IQR @-@ @ ) , @ breast cancers have been reported ( @ -LSB- @ % -RSB- in @ patients in the tamoxifen group vs @ -LSB- @ % -RSB- in @ women in the placebo group ; hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ @ -RSB- , p < @ ) .


The risk of developing breast cancer was similar between years @-@ ( @ -LSB- @ % -RSB- in @ women in the placebo group vs @ -LSB- @ % -RSB- in @ women in the tamoxifen group ; hazard ratio -LSB- HR -RSB- @ -LSB- @ % CI @-@ @ -RSB- , p = @ ) and after @ years ( @ -LSB- @ % -RSB- in @ women vs @ -LSB- @ % -RSB- in @ , respectively ; HR @ -LSB- @-@ @ -RSB- , p = @ ) .


The greatest reduction in risk was seen in invasive oestrogen receptor-positive breast cancer ( HR @ -LSB- @ % CI @-@ @ -RSB- , p < @ ) and ductal carcinoma in situ ( @ -LSB- @-@ @ -RSB- , p = @ ) , but no effect was noted for invasive oestrogen receptor-negative breast cancer ( HR @ -LSB- @ % CI @-@ @ -RSB- , p = @ ) .


These results show that tamoxifen offers a very long period of protection after treatment cessation , and thus substantially improves the benefit-to-harm ratio of the drug for breast cancer prevention .


To assess whether the combination of early inhaled nitric oxide ( iNO ) therapy and vitamin A supplementation lowers the incidence of bronchopulmonary dysplasia ( BPD ) in premature newborns with respiratory failure .


A total of @ mechanically ventilated infants ( birth weight @-@ g ) were randomized ( after stratification by birth weight ) to receive placebo or iNO ( @ ppm ) for @ days or until extubation ( @-@ , @-@ , or @-@ g ) .


A total of @ newborns received iNO , and of these , @ ( @ % ) received vitamin A according to their enrollment center .


We compared patients who received iNO + vitamin A with those who received iNO alone .


The primary outcome was a composite of death or BPD at @ weeks postconceptual age .


BPD was reduced in infants who received iNO + vitamin A for the @-@ g birth weight group compared with iNO alone ( P = @ ) .


This group also showed a reduction in the combined outcome of BPD + death compared with iNO alone ( P = @ ) .


The use of vitamin A did not change the risk for BPD in the placebo group .


Overall , the use of vitamin A was low ( @ of @ patients , or @ % ) .


Combined therapy improved Bayley Scales of Infant Development II Mental and Psychomotor Developmental Index scores at @ year compared with infants treated solely with iNO for the @-@ g birth weight group .


In this retrospective analysis of the nonrandomized use of vitamin A , combined iNO + vitamin A therapy in preterm infants with birth weight @-@ g reduced the incidence of BPD and BPD + death and improved neurocognitive outcomes at @ year in the @-@ g birth weight group .


Hypercholesterolemia is a strong risk factor in cardiovascular disease .


Oat ( Avena sativa L. ) beta-glucan , the soluble fiber in oat , has been known to reduce blood cholesterol levels considerably .


However , the effect of oat soluble fiber in the Thai population is unknown .


To determine the effect of oat consumption on serum lipid profiles in Thai hypercholesterolemic adults .


The present study was a randomized , crossover design .


Twenty-four hypercholesterolemic adults , male and female aged @-@ years , were randomly assigned into two groups of twelve each .


Group @ consumed @ g ( @ g beta-glucan ) of oatmeal daily through the first @-week intervention , and then switched to @ g rice porridge ( control product ) daily for the next @-week intervention .


Group @ consumed rice porridge first and then oatmeal .


Before and after each intervention period , lipid profiles including total cholesterol ( TC ) , triglycerides ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , and low density lipoprotein cholesterol ( LDL-C ) of all subjects were measured .


Following daily oat consumption , total cholesterol and LDL-cholesterol levels were significantly lower than baseline levels and lower than the levels observed with rice consumption .


Oat consumption reduced total cholesterol by @ % and LDL-cholesterol by @ % from baseline levels .


In addition , mean and percent changes were significantly different from the levels after consuming rice porridge ( p < @ ) .


Oatmeal reduced serum total cholesterol and LDL-cholesterol levels in hypercholesterolemic Thai adults .


Hence , oat consumption is a reasonable recommendation for Thai individuals with hyperlipidemia .


Chest pain is the second most common reason patients visit emergency departments ( EDs ) and often results in very low-risk patients being admitted for prolonged observation and advanced cardiac testing .


Shared decision-making , including educating patients regarding their @-day risk for acute coronary syndrome ( ACS ) and management options , might safely decrease healthcare utilization .


This is a protocol for a multicenter practical patient-level randomized trial to compare an intervention group receiving a decision aid , Chest Pain Choice ( CPC ) , to a control group receiving usual care .


Adults presenting to five geographically and ethnically diverse EDs who are being considered for admission for observation and advanced cardiac testing will be eligible for enrollment .


We will measure the effect of CPC on ( @ ) patient knowledge regarding their @-day risk for ACS and the available management options ( primary outcome ) ; ( @ ) patient engagement in the decision-making process ; ( @ ) the degree of conflict patients experience related to feeling uninformed ( decisional conflict ) ; ( @ ) patient and clinician satisfaction with the decision made ; ( @ ) the rate of major adverse cardiac events at @days ; ( @ ) the proportion of patients admitted for advanced cardiac testing ; and ( @ ) healthcare utilization .


To assess these outcomes , we will administer patient and clinician surveys immediately after each clinical encounter , obtain video recordings of the patient-clinician discussion , administer a patient healthcare utilization diary , analyze hospital billing records , review the electronic medical record , and conduct telephone follow-up .


This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes , safety , and healthcare utilization in low-risk chest pain patients from a variety of geographically and ethnically diverse EDs .


To evaluate the efficacy of a combined neurolytic block of the celiac and superior hypogastric plexuses for incapacitating upper abdominal cancer pain .


Fifty-two patients with advanced upper abdominal malignancies and incapacitating pain were equally randomized to receive a combined neurolytic block of the celiac and superior hypogastric plexuses ( combined group ) or a neurolytic celiac plexus block alone ( NCPB group ) using a @ % ethanol trans-intervertebral disk approach under CT guidance .


Visual analogue scores ( VAS ) , morphine consumption , and quality of life ( QoL ) were assessed before the procedure and @ hrs , @ week , @ month , and @ months after the procedure .


The complications and side effects were also recorded .


The amount of ethanol used was @ @ ml in the combined group and @ @ ml in the NCPB group .


VAS scores and morphine consumption decreased significantly pre - compared to post-procedure in both groups ( p < @ ) .


QoL significantly improved @ hrs , @ week , and @ month after the procedure compared with each group pre-procedure ( p < @ ) , but not after @ months ( p > @ ) .


The combined group had significantly lower VAS and morphine consumption than the NCPB group ( p < @ ) .


QoL scores were significantly higher in the combined group @ hrs , @ week , and @ month post-procedure than the NCPB group ( p < @ ) , but not after @ months ( p > @ ) .


A combined neurolytic block of the celiac and superior hypogastric plexuses is more effective than neurolytic celiac plexus block alone in pain relief for patients with advanced upper abdominal cancer .


To assess the effectiveness of task-oriented approach in treating patients with spastic dysarthria .


A randomized control trial was undertaken in @ inpatients diagnosed with spastic dysarthria at the Department of Rehabilitation Medicine in West China Hospital .


All of the participants received basic medical therapy , occupational therapy , physical therapy , and an articulation approach for speech therapy by a professional speech therapist over a one month period .


A task-oriented approach was added to the speech therapy regime of the test group of participants by another professional speech therapist over the same period of time .


The outcomes of speech therapy were measured by the Frenchay dysarthria assessment ( FDA ) .


Significant improvements were found in the test group in relation to @ FDA items , such as dribbling , lips spread , and palate maintenance ( P < @ ) .


The performance of the participants in the test group on the rest of FDA items also demonstrated an improvement trend compared with that of the controls ( P > @ ) except for the three items in relation to cough , lips at rest and jaw in speech .


Task-oriented approach for speech therapy is effective in treating patients with spastic dysarthria .


A task-oriented approach in combination with an articulation approach can produce better patient outcomes compared with the articulation approach alone .


Further studies are warranted .


This report is the second analysis of a prospective randomized trial to investigate the impact of ( @ ) F-fluorodeoxyglucose positron emission tomography ( FDG-PET ) on cervical cancer patients with enlarged pelvic lymph nodes identified by magnetic resonance imaging .


Patients with newly diagnosed cervical cancer with enlarged pelvic lymph nodes but free of enlarged para-aortic lymph nodes ( PALN ) were eligible .


Patients were randomized to receive either pretreatment FDG-PET ( PET arm ) or not ( control arm ) .


The whole pelvis was the standard irradiation field for all patients except those with FDG-avid extrapelvic findings .


In all , @ patients were enrolled .


Pretreatment PET detected extrapelvic metastases in @ patients .


No new patient experienced treatment failure during the additional @-year follow-up period .


There were no significant differences between the PET arm and the control arm regarding overall survival , disease-free survival , and freedom from extrapelvic metastasis .


In the control arm , @ of @ patients with PALN relapse had limited extrapelvic nodal failures ; their @-year disease-specific survival was @ % .


By contrast , only @ of @ patients with PALN relapse in the PET arm experienced such limited failures ; their @-year survival rate was @ % .


Although the pretreatment detection of PALN did not translate into survival benefit , it indeed decreased the need for extended-field concurrent chemoradiation therapy .


To demonstrate the bioequivalence between the test and reference formulations of losartan/hydrochlorothiazide @ + @ mg tablet and evaluate the effect of ethnicity on pharmacokinetics properties of losartan , losartan carboxylic acid and hydrochlorothiazide on healthy Asian Indian and Japanese volunteers .


Randomized , open-label , crossover , bioavailability studies were conducted separately in healthy Asian Indian and Japanese volunteers .


One tablet either of test or of reference product was administered after @ hours of overnight fasting .


After dosing , serial blood samples were collected for a period of @ hours for both the studies .


Plasma samples were analyzed for losartan , losartan carboxylic acid and hydrochlorothiazide by a validated liquid chromatographic and mass spectrometric method ( LC-MS/MS ) .


The pharmacokinetic parameters AUC@-t , AUC@ - , Cmax , tmax , and other pharmacokinetics parameters were determined from plasma concentration-time profiles for both test and reference formulations of losartan/hydrochlorothiazide @ + @ mg tablets .


Statistical evaluations were done to evaluate bioequivalence between generic test formulation ( EPR@ ) and Japanese reference product ( Preminent ) .


Losartan , losartan carboxylic acid and hydrochlorothiazide were well tolerated by subjects in all periods of each study under fasted conditions .


No serious adverse events were observed .


The ratios of least square means for AUC@-t and Cmax and the affiliated @ % confidence intervals were within acceptance range recommended by PMDA .


Marginal differences were observed in pharmacokinetic values of Asian Indian and Japanese volunteers .


The results of these bioavailability studies indicate that the test formulation of losartan/hydrochlorothiazide @ + @ mg ( EPR@ ) tablets is bioequivalent to marketed Preminent reference formulation in Asian Indian and Japanese volunteers , when administered under fasting conditions .


Both test and reference formulations were well tolerated as a single oral dose when administered to healthy adult subjects under fasted conditions .


Although Asian Indian and Japanese volunteers are ethnically different , results of these studies indicate that pharmacokinetic parameters of Asian Indian and Japanese volunteers are comparable to each other in terms of bioavailability of losartan , losartan carboxylic acid and hydrochlorothiazide .


Similar least square means ratios were obtained in Asian Indian and Japanese volunteers demonstrating that a bioequivalence study conducted on Japanese volunteers seems to be substituted by Asian Indian volunteers ' studies .


Suboptimal vitamin D status is highly prevalent in Northern communities , particularly in those patients with chronic diseases such as diabetes and chronic renal disease .


Emerging literature suggests that adherence to daily vitamin D supplementation may be an important factor influencing vitamin D status and overall bone health , but compliance with therapies for bone health is a major challenge .


It is unknown what level of vitamin D supplementation will ameliorate or improve suboptimal vitamin D status in patients with diabetic nephropathy or contribute to improved bone health , particularly for those living in northern climates .


The study purpose was to examine two different strategies of vitamin D@ supplementation ; daily dosing of @IU per day verses monthly dosing of @,@ IU per month on markers of vitamin D status , bone health and to examine whether adherence , quality of life and patient satisfaction with the supplementation strategy differs between the two vitamin D strategies in adults diagnosed with diabetic nephropathy .


The need for RCTs assessing higher doses of vitamin D@ supplementation at varying frequencies of administration and its impact on bone health in adults with diabetes and chronic kidney disease are needed .


Deodorant use during radiation therapy for breast cancer has been controversial as there are concerns deodorant use may exacerbate axillary skin toxicity .


The present study prospectively determined the use of both aluminum-containing and non aluminum containing deodorants on axillary skin toxicity during conventionally fractionated postoperative radiation therapy for breast cancer .


This @-arm randomized controlled study was conducted at a single center , tertiary cancer hospital between March @ and April @ .


Participants were randomized to @ of @ experimental groups ( aluminum-containing deodorant and soap or non-aluminum containing deodorant and soap ) or a control group ( soap ) .


A total of @ participants were randomized .


Generalized estimating equations were used to estimate and compare the odds of experiencing high levels of sweating and skin toxicity in each of the deodorant groups to the odds in the control group .


The study evaluated a range of endpoints including objective measurements of axilla sweating , skin toxicity , pain , itch and burning .


Quality of life was assessed with a validated questionnaire .


Radiation characteristics were similar across all groups .


Patients in the deodorant groups did not report significantly different ratings for axillary pain , itch , or burning compared with the control group .


Patients in the aluminum-containing deodorant group experienced significantly less sweating than the control ; the odds of their sweating being barely tolerable and frequently or always interfering with their daily activities was decreased by @ % ( odds ratio , @ ; @ % confidence interval , @-@ @ ) .


We found no evidence that the use of either aluminum-containing or non-aluminum containing deodorant adversely effects axillary skin reaction during conventionally fractionated radiation therapy for breast cancer .


Our analysis also suggests patients in the aluminum-containing deodorant arm had significantly less sweating without increased symptoms of axillary radiation skin toxicity .


These results add to the evidence that the prescription of deodorants during radiation therapy for breast cancer is now questionable .


Ticagrelor outperforms clopidogrel in preventing cardiovascular events in acute coronary syndrome .


Despite the inclusion of a loading dose in the Platelet Inhibition and Patient Outcomes ( PLATO ) trial for all patients randomized to ticagrelor , it may not be necessary in patients receiving ongoing clopidogrel therapy .


The aim of the present study was to assess whether a ticagrelor loading dose is associated with a further platelet inhibition during the switch from clopidogrel to ticagrelor in patients with acute coronary syndrome receiving ongoing antiplatelet treatment .


Fifty patients with acute coronary syndrome receiving aspirin and clopidogrel treatment were randomly assigned to a starting dose of ticagrelor ( group @ , @ mg ; group @ , @ mg ) .


Platelet aggregation was measured using multiple electrode aggregometry and standard light transmission aggregometry just before the switch and at @ , @ , @ , and @ hours .


No relevant difference in platelet aggregation was observed between the @ study arms at baseline ( P = @ ) .


Residual platelet aggregation was significantly reduced in both arms @ hours after the first administration of ticagrelor ( P < @ for both ) , with no difference in aggregation between groups ( multiple electrode aggregometry , @ versus @ U ; P = @ ) .


Similar results were observed with LTA .


Switching from clopidogrel to ticagrelor without a reloading dose is feasible , and it does not hinder platelet aggregation inhibition in patients with acute coronary syndrome .


Further prospective studies are needed to assess the clinical relevance of our findings .


To evaluate the association of duration of magnesium sulfate infusion with stillbirth or death , cerebral palsy , and select adverse maternal and neonatal outcomes .


This is a secondary cohort analysis of women randomized to receive magnesium sulfate within a previously reported Maternal-Fetal Medicine Units Network prospective clinical trial .


The association of antenatal infusion of magnesium sulfate for less than @ hours , @-@ hours , and greater than @ hours on maternal and perinatal outcomes was compared .


The primary outcome was cerebral palsy of any severity or death .


Secondary outcomes included cerebral palsy , death , and select maternal and neonatal outcomes .


Stratified and logistic regression analyses were used .


The models were adjusted for race , gestational age at birth , time since last magnesium sulfate , any magnesium sulfate at delivery , and eligibility criteria as appropriate .


Of @ women available for analysis , @ , @ , and @ received antenatal magnesium sulfate infusion for a total of less than @ hours , @-@ hours , or greater than @ hours , respectively .


Any cerebral palsy or death occurred in @ women ( @ % ) who received magnesium sulfate less than @ hours , @ women ( @ % ) who received @-@ hours of magnesium sulfate , and @ women ( @ % ) who received greater than @ hours of magnesium sulfate .


There was no difference in death or cerebral palsy among groups ( less than @ hours as reference ; adjusted odds ratio -LSB- OR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ for @-@ hours ; adjusted OR @ , @ % CI @-@ @ for greater than @ hours ) .


Select maternal adverse drug affects and neonatal morbidities were also similar across groups .


The duration of antenatal magnesium sulfate infusion is not associated with risk of death or cerebral palsy .


The optimal treatment duration needed for maximal neuroprotection remains unknown .


: II .


Clear directions and explanations from nurses related to health behaviors and discharge procedures have been shown to effectively reduce the risk of patient readmission .


Nurses thus need to develop good communication skills in order to ensure that their communications help patients become better-informed and less anxious about discharge procedures .


This research evaluates the communication skills of nurses following two different education interventions .


Experimental design principles for education interventions were followed in this research .


Medical nurses certified at the N to N@ level in a municipal hospital in Taipei City were enrolled as participants ( N = @ ) and divided into an experimental group and control group using stratified purposive randomization .


The experimental group received clinical scenario-based simulation education for communication .


The control group received standard class-based education for communication .


Both groups received a pre-test evaluation and an OSCE post-test evaluation .


Results were analyzed using SPSS @ software .


Independent t-test results revealed significant increases in communication skills ( t = @ , p < @ ) in both groups , with the increase in the experimental group ( M = @ , SD = @ ) significantly greater than the increase in the control group ( M = @ , SD = @ ) .


However , the mean scores from the post-test standardized patient survey found no significant differences between the two groups in terms of communication skills .


The results indicate that the clinical scenario-based simulation education intervention is more effective than traditional class-based education in enhancing the communication skills of nurses .


Abdominal aortic aneurysm patients tend to be informed inconsistently and incompletely about their disorder and the treatment options open to them .


The objective of this trial was to evaluate whether these patients are better informed and experience less decisional conflict regarding their treatment options after viewing a decision aid .


A six-centre , randomised clinical trial comparing a decision aid plus regular information versus regular information from the surgeon .


Included patients had recently been diagnosed with an asymptomatic abdominal aortic aneurysm at least @ cm in diameter .


The decision aid consisted of a one-time viewing of an interactive CD-ROM elaborating on elective surgery versus watchful waiting .


Generally , the decision aid advised patients with aneurysms less than @ cm to agree to watchful waiting , for larger aneurysms the decision aid provided insight into the balance of benefit and harm of surgical and conservative approaches , taking into account age , co-morbidity and size of the aneurysm .


The primary outcome was patient decisional conflict measured at @ month follow-up ( Decisional Conflict Scale ) .


Secondary outcomes were patient knowledge , anxiety and satisfaction .


In @ aneurysm patients , decisional conflict scores did not differ significantly between the decision aid and the regular information groups ( @ vs. @ on the @-@ Decisional Conflict Scale ; p = @ ) .


Patients in the decision aid group had significantly better knowledge ( @ vs. @ out of @ points ; p = @ ) , whereas anxiety levels ( @ and @ on a @-@ scale ; p = @ ) and satisfaction scores ( @ and @ on a @-@ scale ; p = @ ) were similar in both groups .


In addition to regular patient-surgeon communication , a decision aid helps to share treatment decisions with abdominal aortic aneurysm patients by increasing their knowledge about the disorder and available treatment options without raising anxiety levels ; however , it does not reduce decisional conflict , nor does it improve satisfaction .


Patients with isolated locoregional recurrences ( ILRR ) of breast cancer have a high risk of distant metastasis and death from breast cancer .


We aimed to establish whether adjuvant chemotherapy improves the outcome of such patients .


The CALOR trial was a pragmatic , open-label , randomised trial that accrued patients with histologically proven and completely excised ILRR after unilateral breast cancer who had undergone a mastectomy or lumpectomy with clear surgical margins .


Eligible patients were enrolled from hospitals worldwide and were centrally randomised ( @:@ ) to chemotherapy ( type selected by the investigator ; multidrug for at least four courses recommended ) or no chemotherapy , using permuted blocks , and stratified by previous chemotherapy , oestrogen-receptor and progesterone-receptor status , and location of ILRR .


Patients with oestrogen-receptor-positive ILRR received adjuvant endocrine therapy , radiation therapy was mandated for patients with microscopically involved surgical margins , and anti-HER@ therapy was optional .


The primary endpoint was disease-free survival .


All analyses were by intention to treat .


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


From Aug @ , @ , to Jan @ , @ , @ patients were randomly assigned to receive chemotherapy and @ were assigned to no chemotherapy .


At a median follow-up of @ years ( IQR @-@ @ ) , @ ( @ % ) patients had disease-free survival events in the chemotherapy group compared with @ ( @ % ) in the no chemotherapy group .


@-year disease-free survival was @ % ( @ % CI @-@ ) with chemotherapy versus @ % ( @-@ ) without chemotherapy ( hazard ratio @ -LSB- @ % CI @-@ -RSB- ; p = @ ) .


Adjuvant chemotherapy was significantly more effective for women with oestrogen-receptor-negative ILRR ( pinteraction = @ ) , but analyses of disease-free survival according to the oestrogen-receptor status of the primary tumour were not statistically significant ( pinteraction = @ ) .


Of the @ patients who received chemotherapy , @ ( @ % ) had serious adverse events .


The most common adverse events were neutropenia , febrile neutropenia , and intestinal infection .


Adjuvant chemotherapy should be recommended for patients with completely resected ILRR of breast cancer , especially if the recurrence is oestrogen-receptor negative .


This meta-analysis compared the earliest clinical effects of intra-articular bupivacaine and morphine for pain management following arthroscopic knee surgery .


A comprehensive literature search was conducted using MEDLINE ( @ to @ ) , the Cochrane Central Register of Controlled Trials ( CENTRAL ) , Embase , and Google Scholar databases for identification of randomized-controlled trials that compared IA bupivacaine and morphine for postoperative pain .


The relative risk , weighted mean difference ( WMD ) , and their corresponding @ % confidence intervals ( CI ) were calculated using RevMan statistical software .


Bupivacaine and morphine group had similar acute postoperative pain scores ( WMD : @ ; @ % CI , -@ to @ ; P = @ ) ; number of patients requiring supplementary analgesia ( relative risk : @ ; @ % CI , @ to @ ; P = @ ) for the trials in this meta-analysis ( n = @ ) ; and side effects ( relative risk : @ ; @ % CI , @ to @ , P = @ ) .


Even though , the time to first analgesic request resulted in a significant difference ( WMD : @ ; @ % CI , @ to @ , P = @ ) , this result was not supported by the sensitivity analysis .


On the basis of the currently available literature , this study failed to demonstrate a significant difference between single-dose intra-articular bupivacaine and morphine at the end of the arthroscopic knee surgery in terms of pain relief , need for supplementary analgesics , times interval before the first request for additional analgesic , and short-term side effects .


Level II-meta-analysis of Level I and II studies .


To evaluate the outcome of accelerated and conventional corneal cross-linking ( CXL ) procedures regarding their effect on morphological and optical properties of the cornea .


One hundred fifty-three eyes of @ patients were evaluated before and during a @-month follow-up period after CXL ( @ eyes in the conventional group and @ eyes in the accelerated group ) .


Measured variables include corrected distance visual acuity ( CDVA ) , uncorrected distance visual acuity ( UDVA ) , refraction , maximum keratometry , endothelial cell density , anterior and posterior stromal keratocyte density , and subbasal nerve density .


All variables were compared between the two study groups .


Cylindrical and spherical components of refraction improved significantly during @ months of follow-up .


No difference was observed between the two study groups .


UDVA and CDVA improved in the same manner , with no intergroup differences .


Endothelial cell density did not change significantly during the follow-up period in either group .


K-max increased slightly in the first month of the follow-up , but started to decrease at postoperative visits without any significant difference in the two groups .


Anterior stromal keratocyte density and subbasal nerve density decreased significantly in both groups @ month postoperatively .


Both variables had a more significant decrease in the conventional group at all visits before the @-year visit .


At the final @-month visit , there were no significant differences in any value between the two groups .


Accelerated and conventional CXL seem to have a comparable and acceptable effect on keratoconus in the short-term follow-up period .


Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors @-@ , approved for second-line treatment of advanced renal cell carcinoma ( RCC ) .


Preclinical studies did not indicate potential for axitinib-induced delayed cardiac repolarization .


The effect of axitinib on corrected QT ( QTc ) prolongation was evaluated with one-stage concentration-QTc response modeling using data from a definitive randomized crossover QT phase I study in healthy volunteers administered one single @-mg axitinib dose alone or in the presence of steady-state ketoconazole ( @mg once daily ) .


Axitinib and ketoconazole had opposite effects on heart rate : Axitinib lowered it , ketoconazole raised it .


The final analysis showed a flat relationship between QTc and axitinib concentration ( slope -@ msmL/ng ) for axitinib alone .


Mean highest placebo-matched change from baseline in QTc was -@ -LSB- @ % confidence interval ( CI ) -@ , -@ -RSB- ms. At supratherapeutic axitinib exposures achieved with potent cytochrome P@ @A@/@ inhibition by ketoconazole , the model predicted mean QTc change of @ ( @ % CI @-@ @ ) ms. The slope population mean estimate was -@ ( @ % CI -@ , @ ) msmL/g for ketoconazole alone and @ ( @-@ @ ) msmL/ng for axitinib in the presence of ketoconazole .


The results were then compared with those obtained based on more widely used Fridericia 's , Bazett 's , and study-specific correction methods .


Since axitinib plasma concentrations observed in this study exceeded the range of concentrations observed in patients with RCC at the highest approved clinical dose ( @mg twice daily ) , axitinib was not associated with clinically significant QTc prolongation in target populations .


Adolescent metabolic syndrome ( MetS ) predicts type @ diabetes mellitus and subclinical atherosclerosis in adulthood .


Our aim was to establish the relationship between an infancy-onset dietary intervention and risk of having MetS between @ and @ years of age .


The Special Turku Coronary Risk Factor Intervention Project for Children ( STRIP ) study is a longitudinal , randomized atherosclerosis prevention trial in which repeated dietary counseling aiming at reducing intake of saturated fat took place from infancy to early adulthood .


Participants who had complete data on the MetS components ( waist circumference , blood pressure , triglycerides , glucose , high-density lipoprotein cholesterol ) at @ ( n = @ ) , @ ( n = @ ) , @ ( n = @ ) , @ ( n = @ ) , @ ( n = @ ) , and @ ( n = @ ) years of age were included in the study .


Modified International Diabetes Foundation criteria with @th/@th percentile cutoff points for the components were primarily applied in statistical analyses , and the results were replicated with the use of other pediatric MetS definitions .


Between the ages of @ and @ years , the prevalence of MetS varied between @ % and @ % in participants in the intervention group and between @ % and @ % in the control group .


The long-term relative risk of MetS was significantly lower in the intervention group ( relative risk , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Of the individual MetS components , the intervention decreased risk of high blood pressure in both sexes ( relative risk , @ ; @ % confidence interval , @-@ @ ) and high triglycerides in male subjects ( relative risk , @ ; @ % confidence interval , @-@ @ ) .


A statistically nonsignificant reduction was seen in the risk of high waist circumference in the intervention individuals ( relative risk , @ ; @ % confidence interval , @-@ @ ) .


Repeated infancy-onset dietary intervention is effective in the prevention of MetS in adolescence .


To evaluate the clinical efficacy of the coronary sinus ( CS ) Reducer in attenuating angina severity in patients suffering from severe refractory angina .


Patients with refractory angina , objective evidence of myocardial ischaemia and no option for revascularisation were treated with CS Reducer implantation at two medical centres .


Six-month follow-up evaluation consisted of clinical assessment of angina severity .


Objective assessment of ischaemia at six-month follow-up was performed in one of the two centres .


Successful CS Reducer implantation was achieved in @ of @ eligible patients , at both centres .


No device-related adverse effects were observed during the procedure or the follow-up period .


Canadian Cardiovascular Society ( CCS ) score diminished from a mean of @ at baseline to @ at six months ( n = @ , p < @ ) , exercise duration was prolonged from @:@ to @:@ min ( min : sec ; n = @ , p = @ ) .


Thallium SPECT summed stress score and summed difference score were both reduced ( n = @ , @ vs. @ , p = @ , and @ vs. @ , p = @ , respectively ) .


Wall motion score index at peak dobutamine infusion was also significantly improved ( n = @ , @ vs. @ , p = @ ) .


CS Reducer implantation was safe and resulted in significant improvement of angina class .


The results of the ongoing randomised sham-control trial will address the concern regarding the possible placebo effect , and hopefully further support our encouraging observations .


To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy .


A multicenter randomized study conducted between @ and @ .


Computer generated randomization was stratified by site .


Patients and evaluating physicians were blinded to treatment outcomes .


Eight military , Veterans Administration , and civilian hospitals .


@ people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain .


Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin .


Average leg pain one and three months after the injection on a @-@ numerical rating scale .


A positive outcome was defined as a @ point decrease in leg pain coupled with a positive global perceived effect .


All patients had one month follow-up visits ; patients whose condition improved remained blinded for their three month visit .


There were no significant differences for the primary outcome measure at one month ( mean pain score @ ( SD @ ) and mean change from baseline -@ ( SD @ ) in epidural steroid injection group versus @ ( SD @ ) and -@ ( SD @ ) in gabapentin group ; adjusted difference @ , @ % confidence interval -@ to @ ; P = @ ) and three months ( mean pain score @ ( SD @ ) and mean change from baseline -@ ( SD @ ) versus @ ( SD @ ) and -@ ( SD @ ) , respectively ; adjusted difference @ , -@ to @ ; P = @ ) .


Among secondary outcomes , one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain ( -@ , SD @ ) than those treated with gabapentin ( -@ , SD @ ; P = @ ) and were more likely to experience a positive successful outcome ( @ % v @ % ; number needed to treat = @ , @ % confidence interval @ to @ ; P = @ ) .


At three months , there were no significant differences between treatments .


Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures , the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier : NCT@ .


This study sought to examine the utility of hair testing as a research measure of drug use among individuals with moderate-risk drug use based on the internationally validated Alcohol , Smoking , and Substance Involvement Screening Test ( ASSIST ) .


This study is a secondary analysis using baseline data from a randomized trial of brief intervention for drug misuse , in which @ adults with moderate-risk drug use were recruited from two community clinics in New Mexico , USA .


The current study compared self-reported drug use on the ASSIST with laboratory analysis of hair samples using a standard commercially available @-panel test with assay screening and gas chromatography/mass spectrometry ( GC/MS ) confirmation .


Both self-report and hair testing covered a @-month period .


Overall concordance between hair testing and self-report was @ % ( marijuana ) , @ % ( cocaine ) , @ % ( amphetamines ) , and @ % ( opioids ) .


Specificity of hair testing at standard laboratory cut-offs exceeded @ % for all drugs , but sensitivity of hair testing relative to self-report was low , identifying only @ % ( @/@ ) of self-disclosed marijuana users , @ % ( @/@ ) of cocaine users , @ % ( @/@ ) of amphetamine users , and @ % ( @/@ ) of opioid users .


Among participants who disclosed using marijuana or cocaine in the past @ months , participants with a negative hair test tended to report lower-frequency use of those drugs ( p < @ for marijuana and cocaine ) .


Hair testing can be useful in studies with moderate-risk drug users , but the potential for under-identification of low-frequency use suggests that researchers should consider employing low detection cut-offs and using hair testing in conjunction with self-report .


Fingertip injuries , which are the most common hand injury , represent management challenges for hand surgeons .


Full thickness skin grafts are routinely used to cover the fingertip site , but has significant donor site morbidity .


As amniotic membranes ( AM ) are used as a dressing substitute in burns , we decided to evaluate the efficacy of AM as a biologic wound dressing material for coverage of these injuries .


In this clinical study , @ patients with full-thickness zone @ fingertip skin loss were included .


The patients were divided into @ groups using the block randomisation method .


In the first group , a skin graft was used for coverage and in the second group , AM was used .


All patients were operated on by the same hand surgeon between February @ to October @ .


The minimum follow-up period was @ months .


Two point discrimination ( T.P.D ) , light touch , healing time , days lost from work and infection rate were evaluated and recorded .


This study recruited @ patients with full-thickness zone @ fingertip skin loss ( age range @-@ years ) .


Fingertips in both groups were assessed .


T.P.D , light touch and days lost from work were significantly lower in the AM group than in the skin graft group .


Healing time was lower in the skin graft group .


In the both groups , no infection was detected .


Patients of both groups were satisfied of their treatment and healing progress .


Our results showed the effectiveness and safety of AM for the treatment of fingertip amputation , which can produce better sensation and functional outcomes than skin graft transplantations .


To identify the effects of a brief educational intervention on stroke patients ' recall and recognition of risk factors and performance of and stage of change for stroke risk-related behaviors .


Sixty-six patients with stroke participated in a multisite randomized controlled trial .


The intervention group ( n = @ ) received a brief education intervention ( tailored written stroke information , verbal reinforcement of information for @ months after discharge , and provision of a telephone number ) .


The control group ( n = @ ) received usual care .


Unprompted recall ( personal and general ) , prompted recognition of risk factors ( @-@ ) , and performance of ( @-@ ) and stage of change for up to @ stroke risk-related behaviors were assessed before and @ months after discharge .


No significant between-group differences were found .


For all participants over time , there were significant improvements for personal ( mean difference -LSB- MD -RSB- , @ ; @ % CI , @-@ @ ; P = @ ) and general ( MD , @ ; @ % CI , @-@ @ ; P = @ ) risk factor recall ; performance of stroke risk-related behaviors ( MD , @ ; @ % CI , @-@ @ ; P < @ ) ; and progression from a nonaction to an action stage of change for @ of @ behaviors over time .


There was a significant decline in total risk factor recognition scores ( MD , -@ ; @ % CI , @-@ @ ; P < @ ) .


Stroke patients ' unprompted recall of risk factors and performance of risk-related behaviors improved over time ; readiness to change risk-related behaviors progressed for some behaviors .


A brief educational intervention did not improve risk factor awareness or behavior change more than usual care .


Epidermal growth factor receptor overexpression is associated with poor outcomes in urothelial carcinoma ( UC ) .


Cetuximab ( CTX ) exhibited an antitumor effect in in vivo UC models .


The efficacy of gemcitabine/cisplatin ( GC ) with or without CTX in patients with advanced UC was evaluated .


Patients with advanced UC , measurable disease , and adequate organ function were randomized @:@ to cisplatin ( @ mg/m ( @ ) ) on day @ plus gemcitabine ( @ mg/m ( @ ) ) on days @ , @ , and @ ( arm A ) or GC plus CTX ( @ mg/m ( @ ) ) on days @ and @ ( arm B ) .


The primary endpoint was the overall response rate .


The secondary endpoints were the response duration , safety , progression-free survival , overall survival , determination of whether or not CTX sensitized nonresponders to GC , and exploratory biomarker analysis .


The accrual targets were @ and @ patients for the @ arms , respectively .


The overall response rate was reported by arm with binomial confidence intervals ( CIs ) .


Kaplan-Meier methods were used for time-to-event endpoints .


Eighty-eight eligible patients were randomized ; @ were toxicity-evaluable , and @ were response-evaluable .


The overall response rates were @ % for arm A ( @ % CI = @ % -@ % ) and @ % for arm B ( @ % CI = @ % -@ % ) .


The median progression-free survival times were @ months for arm A ( @ % CI = @-@ @ months ) and @ months for arm B ( @ % CI = @-@ @ months ) .