Cure rates did not differ significantly between the two treatments in the subgroups of children , adults , and patients with abscess versus cellulitis .


The proportion of patients with adverse events was similar in the two groups .


We found no significant difference between clindamycin and TMP-SMX , with respect to either efficacy or side-effect profile , for the treatment of uncomplicated skin infections , including both cellulitis and abscesses .


( Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences , National Institutes of Health ; ClinicalTrials.gov number , NCT@ . )


Insulin resistance and sympathetic nervous system overactivity are closely associated and contribute to cardiovascular risk .


The objective of the study was to test the hypotheses that pharmacological improvement in insulin sensitivity would ( @ ) attenuate sympathetic neural drive and ( @ ) enhance neuronal norepinephrine uptake .


A randomized , double-blind trial was conducted in @ obese , unmedicated individuals with metabolic syndrome ( mean age @ @ y , body mass index @ @ kg/m ( @ ) ) who received @ weeks of pioglitazone ( PIO ; @ mg for @ wk , then @ mg daily ) or matched placebo .


Clinical measurements included whole-body norepinephrine kinetics -LSB- spillover rate , plasma clearance , and the steady state ratio of tritiated @,@-dihydroxyphenylglycol to tritiated norepinephrine ( -LSB- ( @ ) H -RSB- - DHPG to -LSB- ( @ ) H -RSB- - NE ) as an index of neuronal uptake-@ -RSB- , muscle sympathetic nerve activity , spontaneous baroreflex sensitivity , euglycemic hyperinsulinemic clamp , oral glucose tolerance test , ambulatory blood pressure , and Doppler echocardiography .


PIO treatment increased glucose uptake by @ % and was accompanied by significant reductions in diastolic blood pressure and improved left ventricular diastolic and endothelial function .


Resting muscle sympathetic nerve activity burst frequency decreased by -@ @ burst/min compared with baseline ( P = @ ) , but the magnitude of change was not different from placebo ( P = @ ) .


Norepinephrine spillover and clearance rates and baroreflex sensitivity were unchanged .


Post hoc subgroup analyses revealed an @ % increase in -LSB- ( @ ) H -RSB- - DHPG to -LSB- ( @ ) H -RSB- - NE ratio in hyperinsulinemic ( P = @ ) but not normoinsulinemic subjects ( time group interaction , P = @ ) .


Change in -LSB- ( @ ) H -RSB- - DHPG to -LSB- ( @ ) H -RSB- - NE ratio correlated with improvements in diastolic blood pressure ( r = -@ , P = @ ) , the ratio of early ( E ) to late ( A ) peak transmitral diastolic inflow velocity ( r = @ , P = @ ) , E wave deceleration time ( r = -@ , P = @ ) , and insulin area under the curve@-@ during the oral glucose tolerance test ( r = -@ , P = @ ) .


Compared with placebo , PIO does not affect resting sympathetic drive or norepinephrine disposition in obese subjects with metabolic syndrome .


Treatment induced changes in the -LSB- ( @ ) H -RSB- - DHPG to -LSB- ( @ ) H -RSB- - NE ratio related to reduction in hyperinsulinemia and improvements in diastolic function .


Persons living with HIV ( PLWH ) who also use crack cocaine may have stressful , chaotic lives and typically do not engage in standard medical care that addresses a multitude of extenuating life circumstances .


Yoga/meditation ( YM ) improves quality of life ( QOL ) and biomarkers of stress , but the effect of this intervention is almost unknown in PLWH , particularly those who use crack cocaine .


This pilot study sought to compare the feasibility and acceptability of @-minute , twice-per-week sessions of YM for @ months with those of no-contact control and to evaluate the effects of the intervention on QOL ( according to the Short Form-@ , Perceived Stress Scale -LSB- PSS -RSB- , and Impact of Events Scale -LSB- IES -RSB- ) and salivary cortisol and dehydroepiandrosterone sulfate ( DHEA-S ) among PLWH who use crack cocaine .


Participants were randomly assigned to YM or no-contact control and were assessed at baseline , @ months after the intervention , and @ months ' follow-up .


The YM program was acceptable and feasible , with high overall attendance ( @ % ) and individual participation in yoga sessions ( @ % ) .


YM participants showed modest improvements on QOL .


The PSS total score and the IES intrusion score improved significantly @ months after the intervention , but cortisol and DHEA-S did not change .


This pilot study showed a high level of feasibility and acceptability and modest effects on measures of QOL among PLWH who use crack cocaine .


The results suggest utility of YM as a simple , safe , and inexpensive format to improve QOL in a population that has many medical difficulties and extenuating stressors .


The aim of the study was to compare prefeed abdominal circumference ( AC ) and gastric residual volume ( GRV ) as a measure of feed intolerance in very-low-birth-weight infants ( VLBW ) .


Eighty VLBW infants were randomized to @ groups ; feed intolerance was monitored by measuring either GRV group or prefeed AC group .


The primary outcome was time to full enteral feeds ( @ mL kg day ) .


Other main outcome measures were feed interruption days , duration of parenteral nutrition , incidence of culture positive sepsis , necrotizing enterocolitis , mortality , and duration of hospital stay .


The median ( interquartile range ) time to achieve full feeds was @ ( @-@ ) versus @ ( @-@ @ ) days in AC and GRV groups , respectively ( P < @ ) .


Infants in AC group had fewer feed interruption days ( @ -LSB- @-@ -RSB- vs @ -LSB- @ , @ -RSB- , P < @ ) and shorter duration of parenteral nutrition ( P < @ ) .


The incidence of culture-positive sepsis in AC and GRV groups was @ % and @ % , respectively ( P = @ ) .


Duration of hospital stay and mortality were comparable in both the groups .


Prefeed AC as a measure of feed intolerance in VLBW infants may shorten the time taken to achieve full feeds .


The Framingham risk score ( FRS ) is one of the standard tools used to predict the incidence of coronary heart disease ( CHD ) .


No previous study has investigated its efficacy for a Japanese population cohort .


The purpose of this study was to develop new coronary prediction algorithms for the Japanese population in the manner of the FRS , and to compare them with the original FRS .


Our coronary prediction algorithms for Japanese were based on a large population-based cohort study ( Suita study ) .


The study population comprised @,@ healthy Japanese .


They were followed-up for @ years on average , and @ cases of CHD were observed .


Multiple Cox proportional hazard model by stepwise selection was used to construct the prediction model .


Our coronary prediction algorithms for Japanese patients were based on a large populationbased cohort study ( the Suita study ) .


A multiple Cox proportional hazard model by stepwise selection was used to construct the prediction model .


The C-statistics showed that the new model had better accuracy than the original and recalibrated Framingham scores .


The net reclassification improvement ( NRI ) by the Suita score with the inclusion of CKD was @ % ( P@ @ ) compared with the original FRS .


The recalibration of the FRS slightly improved the efficiency of the prediction , but it was still worse than the Suita score with the CKD model .


The calibration analysis suggested that the original FRS and the recalibrated FRS overestimated the risk of CHD in the Japanese population .


The Suita score with CKD more accurately predicted the risk of CHD .


The FRS and recalibrated FRS overestimated the @-year risk of CHD for the Japanese population .


A predictive score including CKD as a coronary risk factor for the Japanese population was more accurate for predicting CHD than the original Framingham risk scores in terms of the C-statics and NRI .


The aim of our study was to evaluate the success rate of fiberoptic-guided endotracheal intubation through an Intubating Laryngeal Mask Airway ( ILMA ) , a Cobra Perilaryngeal Airway ( Cobra PLA ) , and a C-Trach Laryngeal Mask Airway ( C-Trach ) in patients whose necks are stabilized in a hard cervical collar .


One hundred and eighty ASA I-II patients were randomized to undergo endotracheal intubation after general anesthesia via an ILMA ( group ILMA ) , a C-Trach ( group C-Trach ) or a Cobra PLA ( group CPLA ) with the application of an appropriately-sized hard cervical collar .


A fiberoptic bronchoscope was used for intubation via the ILMA and Cobra PLA .


Rate of successful insertion of an endotracheal tube through the three devices was the primary aim .


Other parameters compared were time taken for device insertion , endotracheal intubation , hemodynamic changes , incidence of hypoxia , and mucosal injury during the procedure .


The incidence of postoperative sore throat was also compared between the three groups .


The success rates of intubation in the ILMA , C-Trach , and CPLA groups were @ , @ , and @ % respectively .


The first-attempt success rate was significantly better with the C-Trach compared to Cobra PLA ( @ vs. @ % , p < @ ) .


The time taken for device insertion was significantly more with the Cobra PLA as compared to that taken with an ILMA or a C-Trach ( @ vs. @ and @ s , respectively ) .


Intubation through a C-Trach took the least amount of time ( @ s ) as compared to an ILMA ( @ s ) or a Cobra PLA ( @ s ) .


The incidence of hypoxia and airway morbidity was similar between the groups .


The success rates of fiberoptic-guided endotracheal intubation through an ILMA and a Cobra PLA are similar to the success rate of intubation using a C-Trach in patients whose cervical spines are immobilized with a hard cervical collar .


To determine whether the sense of coherence ( SOC ) could predict the outcome of an @-month lifestyle intervention program for subjects at risk of type @ diabetes .


Subjects at high risk of type @ diabetes mellitus were recruited to a low-intensity lifestyle intervention program by their general practitioners .


Weight reduction @ % and improvement in exercise capacity of @ % from baseline to follow-up indicated a clinically significant lifestyle change .


SOC was measured using the @-item SOC questionnaire .


The study involved @ subjects with a mean body mass index of @ ( SD @ ) .


Complete follow-up data were obtained for @ ( @ % ) .


Twenty-six participants had clinically significant lifestyle changes .


There was a @ % increase in the odds of a clinically significant lifestyle change for each point increase in the baseline SOC score ( odds ratio = @ ; confidence interval = @-@ @ ) .


The success rate was @ times higher in the highest SOC score tertile group compared with the lowest .


High SOC scores were good predictors of successful lifestyle change in subjects at risk of type @ diabetes .


SOC-@ can be used in daily practice to increase clinical awareness on the impact of mastery on the outcome of life-style intervention programs .


Teduglutide , a recombinant analog of human glucagon-like peptide ( GLP ) -@ , is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support .


Previous studies assessing the effect of GLP-@ on gastric emptying in humans have yielded inconsistent results , with some studies showing no effect and others documenting a GLP-@-dependent delay in gastric emptying .


The primary objective of this study was to assess the effect of teduglutide on gastric emptying of liquids in healthy subjects , as measured by the pharmacokinetics of acetaminophen .


This double-blind , parallel-group , single-center study enrolled and randomized @ healthy subjects ( @ men , @ women ) to receive subcutaneous doses of teduglutide @ mg or placebo ( @:@ ratio ; @:@ ) once daily on Days @ through @ in the morning .


Gastric emptying of a mixed nutrient liquid meal was assessed by measuring acetaminophen levels predose and at @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , and @ hours after administration of @ mg acetaminophen on Days @ and @ .


The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo .


No significant differences in gastric emptying of liquids ( acetaminophen area under the concentration -LSB- AUC -RSB- vs time curve from time @ to the last measurable concentration , AUC extrapolated to infinity , maximum concentration -LSB- Cmax -RSB- , and time to Cmax ) were observed on Day @ in subjects receiving teduglutide @ mg versus subjects receiving placebo .


There were no serious adverse events ( AEs ) , deaths , or discontinuations due to an AE reported during the study .


Teduglutide @ mg/day for @ days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics .


No unexpected safety signals were observed .


Asian Americans have the highest incidence of hepatocellular carcinoma ( HCC ) , the major form of primary liver cancer , of all ethnic groups in the United States .


Chronic hepatitis B virus ( HBV ) infection is the most common cause of HCC , and as many as @ in @ foreign-born Asian Americans are chronically infected with HBV .


We tested the effectiveness of a culturally tailored liver cancer education program for increasing screening for HBV among Chinese , Korean , and Vietnamese Americans residing in the Baltimore-Washington metropolitan area , from November @ through June @ .


We used a cluster randomized controlled trial to recruit volunteer participants from community-based organizations ( CBOs ) in the Baltimore-Washington metropolitan area .


We selected @ participants by using a pretest survey .


People were eligible to participate if they had not attended a hepatitis B-related education program in the past @ years .


The intervention group ( n = @ ) received a @-minute educational program , and the control group ( n = @ ) received an educational brochure .


After attending the educational program , the intervention group completed a post-education survey .


Six months later , participants in both groups were followed up by telephone .


Receipt of HBV screening was the outcome measure .


Approximately @ % ( n = @ ) of participants completed the @-month follow-up telephone survey .


Among those who had not had HBV screening at baseline ( n = @ ) , the adjusted odds of self-reported receipt of HBV screening at the @-month follow-up to the educational program were significantly higher for the intervention group than for the control group ( odds ratio = @ ; @ % confidence interval , @-@ @ ; P < @ ) .


Chinese Americans and Vietnamese Americans had significantly higher odds of having HBV screening in the @-month period than Korean Americans .


Culturally tailored education programs that increase liver cancer awareness can be effective in increasing HBV screening among underserved Asian American populations .


Placental extract has been used as a therapeutic agent with application in various fields of medicine .


Placental extract is well known for its effects on wound healing with anti-inflammatory , antiplatelet , and angiogenic effects and is also a biogenic modulator .


The present study evaluated the effect of placental extract on wound healing , mouth opening , and postoperative patient discomfort in patients with oral submucous fibrosis treated with fibrotomy with buccal fat pad coverage and coronoidectomy .


Ten subjects with oral submucous fibrosis who presented with mouth opening less than @ mm were enrolled in the present prospective randomized controlled trial to assess the effects of placental extract on the fibrotomy wound covered with a pedicled buccal pad fat ( @ patients allocated to the study group , group S and @ to the control group , group C ) .


The following criteria were used to analyze the postoperative effect of placental extract on fibrotomy wounds compared with that of the controls : subjective assessment of the wound , postoperative discomfort , and postoperative mouth opening assessed at @ , @ , and @ weeks postoperatively .


The average difference in the preoperative and fourth week postoperative mouth opening for group C was @ @ mm and was @ @ mm in group S.


The median calculated for group C was a @-mm increase in mouth opening and was @ mm in group S.


The results obtained with topical application of placental extract on fibrotomy wound healing and postoperative mouth opening were superior to those of the control group in whom placental extract was not used .


To investigate the safety of minimal immunosuppression ( IS ) in liver transplantation ( LT ) .


The lack of long-term follow-up studies , including pathologic data , has led to a protean handling of IS in LT.


Between February @ and September @ , @ adults were enrolled in a prospective , randomized , double-blind , placebo-controlled minimization trial comparing tacrolimus placebo ( TAC-PLAC ) and TAC short-term steroid ( TAC-STER ) IS .


All patients had a minimum clinical , biochemical , and histological follow-up of @ years .


Five-year actual patient and graft survival rates in TAC-PLAC and TAC-STER groups were @ % and @ % ( P = @ ) and @ % and @ % ( P = @ ) , respectively .


Five-year biopsies were available in @ ( @ % ) of @ survivors .


Twelve patients refused a biopsy because of their excellent evolution ; tissue material was insufficient in @ patient ; @ had normal liver tests ; and @ patients had developed alcoholic and secondary biliary cirrhosis .


Histology was normal in @ ( @ % ) patients ; @ ( @ % ) had disease recurrence .


The remaining biopsies showed nonspecific chronic hepatitis ( @ % ) , mild inflammatory infiltrates ( @ % ) , and steatosis ( @ % ) .


All findings were equally distributed between both groups .


In each group , @ patients ( @ % ) presented with acute cellular rejection after the first year and only @ ( @ % ) TAC-PLAC patient developed chronic rejection after IS withdrawal because of pneumonitis .


Arterial hypertension , diabetes mellitus , renal insufficiency , hypercholesterolemia , gout , and obesity were equally low in both groups .


Excellent long-term results can be obtained under minimal IS and absence of steroids .


TAC-based monotherapy is feasible in most adult liver recipients until @ years of follow-up .


To evaluate the effects of combining the assessment of circulating high-sensitivity C-reactive protein ( hs-CRP ) with that of Epstein-Barr virus DNA ( EBV DNA ) in the pretherapy prognostication of nasopharyngeal carcinoma ( NPC ) .


Three independent cohorts of NPC patients ( training set of n = @ , internal validation set of n = @ , and prospective validation set of n = @ ) were studied .


Determinants of disease-free survival , distant metastasis-free survival , and overall survival were assessed by multivariate analysis .


Hazard ratios and survival probabilities of the patient groups , segregated by clinical stage ( T@-@N@-@M@ , T@-@N@-@M@ , T@-@N@-@M@ , and T@-@N@-@M@ ) and EBV DNA load ( low or high ) alone , and also according to hs-CRP level ( low or high ) , were compared .


Elevated hs-CRP and EBV DNA levels were significantly correlated with poor disease-free survival , distant metastasis-free survival , and overall survival in both the training and validation sets .


Associations were similar and remained significant after excluding patients with cardiovascular disease , diabetes , and chronic hepatitis B. Patients with advanced-stage disease were segregated by high EBV DNA levels and high hs-CRP level into a poorest-risk group , and participants with either high EBV DNA but low hs-CRP level or high hs-CRP but low EBV DNA values had poorer survival compared with the bottom values for both biomarkers .


These findings demonstrate a significant improvement in the prognostic ability of conventional advanced NPC staging .


Baseline plasma EBV DNA and serum hs-CRP levels were significantly correlated with survival in NPC patients .


The combined interpretation of EBV DNA with hs-CRP levels led to refinement of the risks for the patient subsets , with improved risk discrimination in patients with advanced-stage disease .


Nerve growth factor ( NGF ) is a neurotrophin with therapeutic possibilities that extend from the nervous system to the eye .


We tested the safety , maximal tolerated dose , pharmacokinetics , and antigenicity of a novel human recombinant NGF ( rhNGF ) eye-drop formulation in a phase I study .


This prospective , randomized , double-masked , vehicle-controlled trial , sponsored by Domp SpA ( registered as NCT@ at ClinicalTrials.gov ) , enrolled @ healthy volunteers ( @ females , @ males , age @ years ) .


Subjects were randomized in three cohorts to receive ( @ ) a single eye-drop containing @ , @ , or @ g rhNGF ; ( @ ) a single ascending dose of rhNGF eye drops three times a day for @day ( total daily dose @ , @ , or @ g ) , or vehicle ; or ( @ ) a multiple ascending dose of rhNGF eye drops three times a day for @days ( total dose @ , @ , or @ g ) , or vehicle .


Outcome measures included blood chemistry , urinalyses , vital signs , electrocardiograms ( ECGs ) , serum NGF antibodies , ocular and systemic adverse events ( AEs ) , visual acuity , tear function , intraocular pressure , fundus oculi , and ocular symptoms .


Administration of rhNGF eye drops did not result in a significant increase of circulating NGF levels and no antidrug antibodies were detected in serum .


No serious AEs were recorded , and a few mild , transient ocular AEs related to rhNGF administration were reported only at the highest concentration .


rhNGF eye drops were well tolerated , with no detectable clinical evidence of systemic AEs .


These results pave the way for the development of clinical trials on rhNGF in ophthalmology .


The impact of intraoperative hydrodebrider sinus irrigation ( HSI ) during endoscopic sinus surgery ( ESS ) on postoperative inflammation , endoscopy , and patient-reported outcomes has not been studied .


A clinical trial of @ patients with symmetric chronic rhinosinusitis were prospectively randomized to HSI on one side after undergoing bilateral ESS .


The contralateral side was not treated with any irrigation and served as an internal control .


Preoperative computed tomography , endoscopic , @-item Sino-Nasal Outcome Test ( SNOT-@ ) , and symptom visual analog scale ( VAS ) scores for each side were obtained .


At @ and @ months postsurgery , endoscopy , SNOT-@ , and sinus VAS were recorded .


Sinonasal mucus levels of interleukin ( IL ) -@ , IL-@ , IL-@a , and tumor necrosis factor ( TNF ) alpha were measured at the time of surgery , @ and @ months , postoperatively , from each side .


VAS scores improved on both sides ( p < @ ) and SNOT-@ improved at all postoperative time points ( p < @ ) .


Endoscopic scores of HSI-treated sides did not improve compared with baseline .


HSI had no additional significant impact on postoperative VAS at any time point .


HSI significantly decreased IL-@a levels when compared with the control side at @ month ( p = @ ) and @ months ( p = @ ) .


No significant change was seen in TNF-alpha , IL-@ , or IL-@ on either side at any time point .


Intraoperative HSI at the time of ESS failed to establish any improvement in postoperative endoscopy or most local cytokine levels after ESS .


This study examined whether changes in pH throughout the physiologic range would have a differential effect on central and peripheral factors associated with fatigue and force production during submaximal lower limb isometric exercise to task failure .


Eight males completed three experimental trials -LSB- @ g kg ( -@ ) ammonia chloride ( ACD ) ; @ g kg ( -@ ) calcium carbonate ( PLA ) ; or @ g kg ( -@ ) sodium bicarbonate ( ALK ) -RSB- , each consisting of submaximal calf contractions at @ % of maximal voluntary contraction ( MVC ) to task failure .


Every minute of the task subjects performed an MVC , coupled with stimulation of the tibial nerve during and immediately post MVC .


Time to task failure was not different between trials ( ACD @ @ s , PLA @ @ s , ALK @ @ s ; p = @ ) .


MVC force in all trials declined @ % from the start of exercise to the fifth minute ( mean decline of @ @ N ; p < @ ) , however was not different between trials ( p = @ ) .


Fatigue was mediated in all trials by central and peripheral factors , as declines in voluntary activation , V/M-wave in the soleus and the potentiated resting twitch amplitudes were evident throughout the task ( p < @ ) .


Central fatigue appeared to be muscle specific , as reductions in central drive ( V/M-wave and rate of sEMG rise ) persisted in the soleus but not the medial gastrocnemius .


These data suggest that calf fatigue associated with intermittent , isometric contractions to task failure is unaffected by alterations in pH ; however , central drive reductions may be muscle specific .


We aimed to assess the efficacy and safety of sequential or simultaneous telomerase vaccination ( GV@ ) in combination with chemotherapy in patients with locally advanced or metastatic pancreatic cancer .


TeloVac was a three-group , open-label , randomised phase @ trial .


We recruited patients from @ UK hospitals .


Eligible patients were treatment naive , aged older than @ years , with locally advanced or metastatic pancreatic ductal adenocarcinoma , and Eastern Cooperative Oncology Group performance status of @-@ .


Patients were randomly assigned ( @:@:@ ) to receive either chemotherapy alone , chemotherapy with sequential GV@ ( sequential chemoimmunotherapy ) , or chemotherapy with concurrent GV@ ( concurrent chemoimmunotherapy ) .


Treatments were allocated with equal probability by means of computer-generated random permuted blocks of sizes @ and @ in equal proportion .


Chemotherapy included six cycles of gemcitabine ( @ mg/m ( @ ) , @ min intravenous infusion , at days @ , @ , and @ ) and capecitabine ( @ mg/m ( @ ) orally twice daily for @ days , repeated every @ days ) .


Sequential chemoimmunotherapy included two cycles of combination chemotherapy , then an intradermal lower abdominal injection of granulocyte-macrophage colony-stimulating factor ( GM-CSF ; @ g ) and GV@ ( @ mg ; days @ , @ , and @ , once on weeks @-@ , and six monthly thereafter ) .


Concurrent chemoimmunotherapy included giving GV@ from the start of chemotherapy with GM-CSF as an adjuvant .


The primary endpoint was overall survival ; analysis was by intention to treat .


This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN@ .


The first patient was randomly assigned to treatment on March @ , @ , and the trial was terminated on March @ , @ .


Of @ patients screened , @ were randomly assigned to treatment ( @ patients were allocated to the chemotherapy group , @ to the sequential chemoimmunotherapy group , and @ to the concurrent chemoimmunotherapy group ) .


We recorded @ deaths ; the @ patients still alive were followed up for a median of @ months ( IQR @-@ ) .


Median overall survival was not significantly different in the chemotherapy group than in the sequential chemoimmunotherapy group ( @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ , p = @ ) , or in the concurrent chemoimmunotherapy group ( @ months -LSB- @ % CI @-@ -RSB- , HR @ , @ % CI @-@ , p = @ ; overall log-rank of ( @ ) @df = @ ; p = @ ) .


The commonest grade @-@ toxic effects were neutropenia ( @ -LSB- @ % -RSB- patients in the chemotherapy group , @ -LSB- @ % -RSB- patients in the sequential chemoimmunotherapy group , and @ -LSB- @ % -RSB- patients in the concurrent chemoimmunotherapy group ; fatigue ( @ -LSB- @ % -RSB- in the chemotherapy group , @ -LSB- @ % -RSB- in the sequential chemoimmunotherapy group , and @ -LSB- @ % -RSB- in the concurrent chemoimmunotherapy group ) ; and pain ( @ -LSB- @ % -RSB- patients in the chemotherapy group , @ -LSB- @ % -RSB- in the sequential chemoimmunotherapy group , and @ -LSB- @ % -RSB- in the concurrent chemoimmunotherapy group ) .


Adding GV@ vaccination to chemotherapy did not improve overall survival .


New strategies to enhance the immune response effect of telomerase vaccination during chemotherapy are required for clinical efficacy .


MicroRNAs ( miRNAs ) regulate genes in animals and plants and can be synthesized endogenously .


In milk , miRNAs are encapsulated in exosomes , thereby conferring protection against degradation and facilitating uptake by endocytosis .


The majority of bovine miRNAs have nucleotide sequences complementary to human gene transcripts , suggesting that miRNAs in milk might regulate human genes .


We tested the hypotheses that humans absorb biologically meaningful amounts of miRNAs from nutritionally relevant doses of milk , milk-borne miRNAs regulate human gene expression , and mammals can not compensate for dietary miRNA depletion by endogenous miRNA synthesis .


Healthy adults ( @ men , @ women ; aged @-@ y ) consumed @ , @ , and @ L of milk in a randomized crossover design .


Gene expression studies and milk miRNA depletion studies were conducted in human cell cultures and mice , respectively .


For comparison , feeding studies with plant miRNAs from broccoli were conducted in humans .


Postprandial concentration time curves suggest that meaningful amounts of miRNA ( miR ) -@ b and miR-@c were absorbed ; plasma concentrations of miR-@ did not change ( negative control ) .


The expression of runt-related transcription factor @ ( RUNX@ ) , a known target of miR-@b , increased by @ % in blood mononuclear cells after milk consumption compared with baseline .


When milk exosomes were added to cell culture media , mimicking postprandial concentrations of miR-@b and miR-@c , reporter gene activities significantly decreased by @ % and @ % , respectively , compared with vehicle controls in human embryonic kidney @ cells .


When C@BL/@J mice were fed a milk miRNA-depleted diet for @ wk , plasma miR-@b concentrations were significantly decreased by @ % compared with miRNA-sufficient controls , i.e. , endogenous synthesis did not compensate for dietary depletion .


Broccoli sprout feeding studies were conducted as a control and elicited no detectable increase in Brassica-specific miRNAs .


We conclude that miRNAs in milk are bioactive food compounds that regulate human genes .


Cigarette craving usually occurs in conjunction with unpleasant feelings , including stress , as part of a withdrawal syndrome .


Progressive muscle relaxation ( PMR ) , a behavioral technique used to reduce stress by concentrating on achieving muscle relaxation , may reduce levels of cigarette craving and other substance-related negative feelings and withdrawal symptoms .


Demographic and cigarette use data were collected from @ experienced smokers at the King Chulalongkorn Memorial Hospital , Bangkok , Thailand using the Semi-Structured Assessment for Drug Dependence and Alcoholism .


Participants were asked to refrain from smoking for at least @ hours before the visit ( acute abstinence ) and were randomly allocated to a @-session PMR group ( n = @ ) or a control activity group ( e.g. , reading newspaper , n = @ ) .


The intervention group was instructed to practice PMR individually in a quiet , private , air-conditioned room for about @minutes .


Craving , other substance-related feelings , and autonomic nervous responses ( e.g. , blood pressure and pulse rate ) were assessed immediately before and after the @-session intervention .


There were no differences in demographics , cigarette use/dependence , and baseline craving characteristics between the PMR and control groups .


However , the control group had higher levels of high and paranoia feeling , and pulse rate than the PMR group at baseline .


After practicing PMR , but not after a control activity , smokers undergoing acute abstinence had significantly lower levels of cigarette craving , withdrawal symptoms , and systolic blood pressure than at baseline .


After controlling for baseline differences , abstaining smokers using PMR had lower levels of cigarette craving , withdrawal symptoms , and systolic blood pressure than smokers who undertook a control activity .


PMR significantly reduces cigarette craving , withdrawal symptoms , and blood pressure in smokers undergoing acute abstinence .


PMR may be used as an adjunct to cigarette dependency treatments .


Inoperable aortic stenosis may be treated with either transcatheter aortic valve replacement ( TAVR ) or medical management ( MM ) with or without balloon aortic valvuloplasty ( BAV ) .


The aim of this study was to compare the long-term echocardiographic findings among TAVR , MM , and BAV in patients with severe , inoperable aortic stenosis .


A total of @ inoperable patients in the Placement of Aortic Transcatheter Valves trial were randomized to MM or TAVR .


Echocardiograms obtained at baseline , @ days , and @ , @ , and @ years were analyzed by a central core laboratory .


At baseline , TAVR and MM were similar , with more frequent Society of Thoracic Surgeons score > @ ( @ % vs @ % , P = @ ) and larger end-systolic volumes ( @ @ vs @ @ mL , P = @ ) in MM .


By @ days after TAVR , mean aortic valve gradient had decreased ( from @ @ to @ @ mm Hg , P < @ ) , ejection fraction had increased ( from @ @ % to @ @ % , P < @ ) , and left ventricular ( LV ) mass index had decreased ( from @ @ to @ @ gm/m ( @ ) , P < @ ) .


After @ year , aortic valve gradients and area were unchanged , while LV mass index had decreased by another @ gm/m ( @ ) ( to @ gm/m ( @ ) ) .


By @ days after BAV , mean aortic valve gradient had decreased from @ @ to @ @ mm Hg , while ejection fraction and LV mass index were unchanged ; gradient reverted to baseline at @ year .


No changes in gradients or mass were seen in MM patients .


TAVR results in immediate and sustained relief in pressure overload and improved LV systolic function , with continued regression of hypertrophy over @ years .


Poor clinical results with BAV are explained by the modest and transient reductions in pressure overload with BAV , which were not accompanied by improved LV function or remodeling .


TAVR is the preferred treatment in eligible inoperable patients ( ClinicalTrials.gov identifier NCT@ ) .


Statins are the most commonly prescribed drugs to reduce cardiometabolic risk .


Besides the well-known efficacy of such compounds in both preventing and treating cardiometabolic disorders , some patients experience statin-induced side effects .


We hypothesize that the use of natural bergamot-derived polyphenols may allow patients undergoing statin treatment to reduce effective doses while achieving target lipid values .


The aim of the present study is to investigate the occurrence of an enhanced effect of bergamot-derived polyphenolic fraction ( BPF ) on rosuvastatin-induced hypolipidemic and vasoprotective response in patients with mixed hyperlipidemia .


A prospective , open-label , parallel group , placebo-controlled study on @ patients with elevated serum LDL-C and triglycerides was designed .


Patients were randomly assigned to a control group receiving placebo ( n = @ ) , two groups receiving orally administered rosuvastatin ( @ and @mg/daily for @ days ; n = @ for each group ) , a group receiving BPF alone orally ( @ mg/daily for @ days ; n = @ ) and a group receiving BPF ( @ mg/daily given orally ) plus rosuvastatin ( @mg/daily for @ days ; n = @ ) .


Both doses of rosuvastatin and BPF reduced total cholesterol , LDL-C , the LDL-C/HDL-C ratio and urinary mevalonate in hyperlipidemic patients , compared to control group .


The cholesterol lowering effect was accompanied by reductions of malondialdehyde , oxyLDL receptor LOX-@ and phosphoPKB , which are all biomarkers of oxidative vascular damage , in peripheral polymorphonuclear cells .


Addition of BPF to rosuvastatin significantly enhanced rosuvastatin-induced effect on serum lipemic profile compared to rosuvastatin alone .


This lipid-lowering effect was associated with significant reductions of biomarkers used for detecting oxidative vascular damage , suggesting a multi-action enhanced potential for BPF in patients on statin therapy .


Patients undergoing surgery in the beach chair position ( BCP ) are at a risk of cerebral ischemia .


We evaluated the effect of arginine vasopressin ( AVP ) on hemodynamics and cerebral oxygenation during surgery in the BCP .


Thirty patients undergoing shoulder surgery in BCP under propofol-remifentanil anesthesia were randomly allocated either to receive IV AVP @ U/kg ( AVP group , N = @ ) or an equal volume of saline ( control group , N = @ ) @ minutes before taking BCP .


Mean arterial blood pressure ( MAP ) , heart rate ( HR ) , jugular venous bulb oxygen saturation ( SjvO@ ) , and regional cerebral tissue oxygen saturation ( SctO@ ) were measured after induction of anesthesia and before ( presitting in supine position ) and after patients took BCP .


AVP itself given before the positioning increased MAP and decreased SjvO@ and SctO@ ( P < @ ) , with HR unaffected .


Although MAP was decreased by BCP in both groups , it was higher in the AVP group ( P < @ ) .


While in BCP , HR remained unaltered in the control and decreased in the AVP group .


SjvO@ in BCP did not differ between the groups .


SctO@ was decreased by BCP in both groups , which was more pronounced in the AVP group until the end of study .


The incidence of hypotension ( @ % vs @ % ; P = @ ) was less frequent , and that of cerebral desaturation ( > @ % SctO@ decrease from presitting value ) ( @ % vs @ % ; P = @ ) was higher in the AVP group .


The incidence of jugular desaturation ( SjvO@ < @ % ) was comparable between the groups .


A prophylactic bolus administration of AVP prevents hypotension associated with BCP in patients undergoing shoulder surgery under general anesthesia .


However , it was associated with regional cerebral but not jugular venous oxygen desaturation on upright positioning .


To explore the feasibility , safety , efficacy , and cosmetic outcomes of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy .


From May @ to May @ , we prospectively enrolled @ patients , each of whom had been scheduled for a salpingectomy because of a tubal ectopic pregnancy , and randomized them into two groups : transvaginal endoscopic surgery and laparoscopic approach .


We recorded the estimated blood loss , time of anal exhaust , postoperative pain score , length of stay , and scar assessment scale associated with transvaginal endoscopic access ( n = @ ) ( natural orifice transluminal endoscopic surgery ) and laparoscopic salpingectomy ( n = @ ) ( control group ) for tubal ectopic pregnancy .


The transvaginal salpingectomy was performed with a double-channel endoscope through a vaginal puncture .


A single surgeon performed the surgical procedures in patients in both groups .


The group that underwent the transvaginal endoscopic procedure reported lesser pain at all postoperative visits than the group that underwent the laparoscopic approach .


The duration of time for transvaginal endoscopic surgery was slightly longer than that for the laparoscopic approach .


However , there was no statistically significant difference between the two groups in the duration of operative time .


The group that underwent transvaginal endoscopic surgery was more satisfied with the absence of an external scar than the group that underwent the laparoscopic procedure , which left a scar .


The estimated blood loss , time of anal exhaust , and length of stay were the same in both groups .


The safety and efficacy of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy are equivalent to those of the laparoscopic procedure .


Lesser postoperative pain and a more satisfactory cosmetic outcome were found with the transvaginal endoscopic procedure , making it the more preferred method and superior to the laparoscopic approach .


Acute pancreatitis has a highly variable clinical course .


Early and reliable predictors for the severity of acute pancreatitis are lacking .


Proteinuria appears to be a useful predictor of disease severity and outcome in a variety of clinical conditions .


This study aims to investigate the predictive value of proteinuria on admission for the severity of acute pancreatitis compared with other commonly used predictors ; the APACHE II score , Modified Glasgow score and C-reactive protein ( CRP ) .


This is a post-hoc analysis of @ patients admitted with acute pancreatitis treated in one teaching hospital , who participated in a previous randomized trial .


Proteinuria was defined as a Protein/Creatinine ( P/C ) ratio > @ mg/mmol .


The primary endpoint was severe acute pancreatitis .


Secondary endpoints included infectious complications , need for invasive intervention , ICU stay and in-hospital mortality .


Proteinuria was present in @/@ patients ( @ % ) .


Eleven patients ( @ % ) had severe acute pancreatitis .


There was no difference in incidence of severe acute pancreatitis between patients with and without proteinuria : @/@ patients ( @ % ) versus @/@ patients ( @ % ) respectively ( p = @ ) .


Likewise , the occurrence of infectious complications , need for intervention and ICU stay and mortality did not differ significantly ( p = @ , p = @ , p = @ and p = @ respectively ) .


The diagnostic performance of the P/C ratio for the prediction of severe pancreatitis was inferior to the Modified Glasgow score ( p = @ ) and CRP ( p = @ ) .


Proteinuria on admission does not seem to be a reliable predictor for disease severity in acute pancreatitis .


The diagnostic performance of the P/C ratio is inferior to the Modified Glasgow score and CRP .


To compare the use of magnesium sulfate for @ hours versus @ hours in postpartum women with stable severe pre-eclampsia .


In @ , an open randomized clinical trial was conducted with @ postpartum women with severe pre-eclampsia who gave birth at a tertiary hospital in Brazil ; @ women received magnesium sulfate for @ hours and @ for @ hours .


The analysis was by intention-to-treat and the intervention was not masked .


Abbreviated ( @-hour ) magnesium sulfate therapy was associated with less exposure to the drug , and clinical outcomes were similar in both groups .


No woman developed eclampsia and there was no need to re-initiate treatment after completing the scheduled magnesium sulfate therapy in either group .


Magnesium sulfate therapy was extended in only three women in the @-hour group .


In addition , in this group , significant reductions were found in the duration of postpartum use of an indwelling bladder catheter , the time to ambulation , and the time to maternal contact with the newborn .


Abbreviated postpartum magnesium sulfate therapy in patients with stable severe pre-eclampsia was associated with less drug exposure , similar outcomes , and benefits such as a reduction in the time to contact with the newborn .


Persistent facial erythema is the most common primary pathological feature of rosacea , the only treatment for which is brimonidine tartrate ( BT ) gel .


To assess the relative bioavailability of topical BT gel in comparison with the ophthalmic BT solution .


A pharmacokinetic study was conducted to compare intraindividual systemic exposures after dermal application of BT gel ( @ % , @ % and @ % ) under maximal use conditions in patients with moderate-to-severe facial erythema associated with rosacea , and administration of BT ophthalmic solution @ % .


Patients who received BT ophthalmic solution @ % three times a day for @ day had a mean Cmax of @ @ pg mL ( -@ ) and a mean @-@-h area under the curve ( AUC@-@ h ) of @ @ pg h mL ( -@ ) .


Topical application of BT gel for @ days resulted in quantifiable systemic exposure in @ % , @ % , @ % and @ % of patients who received BT gel @ % twice daily , @ % once daily , @ % twice daily and @ % once daily , respectively .


The mean Cmax values for the BT gels ranged between @ and @ pg mL ( -@ ) , and mean AUC@-@ h values ranged between @ and @ pg h mL ( -@ ) .


Systemic exposure increased with applied dose , with no drug accumulation for the duration of treatment .


The systemic exposure observed with the highest dose of BT gel ( @ % once daily ) was significantly lower than the systemic levels observed for the ophthalmic solution .


@ % apply for all the concentrations .


The systemic safety profile of BT gel may be considered better than that of the ophthalmic solution .


Transoral incisionless fundoplication ( TIF ) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery .


The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease ( GERD ) patients controlled with proton pump inhibitors ( PPIs ) who opted for an endoscopic intervention over lifelong drug dependence .


Patients with chronic GERD were randomized ( @:@ ) for TIF or continuation of PPI therapy .


American Society of Anesthesiologists > @ , body mass index > @kg/m ( @ ) , hiatal hernia > @cm , and esophageal motility disorders were exclusion criteria .


Primary outcome measure was GERD-related quality of life .


Secondary outcome measures were esophageal acid exposure , number of reflux episodes , PPI usage , appearance of the gastroesophageal valve , and healing of reflux esophagitis .


Crossover for the PPI group was allowed after @ months .


A total of @ patients ( TIF n = @ , PPI n = @ , mean body mass index @kg/m ( @ ) , @ male ) were included .


At @ months , GERD symptoms were more improved in the TIF group compared with the PPI group ( P < @ ) , with a similar improvement of distal esophageal acid exposure ( P = @ ) compared with baseline .


The pH normalization for TIF group and PPI group was @ % and @ % , respectively .


All patients allocated for PPI treatment opted for crossover .


At @ months , quality of life remained improved after TIF compared with baseline ( P < @ ) , but no improvement in esophageal acid exposure compared with baseline was found ( P = @ ) and normalization of pH was accomplished in only @ % in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in @ % .


Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients , no long-term objective reflux control was achieved .


The aim was to investigate the effect of skin contact between mother and child in pain relief of full-term newborns during heel blood collection .


The authors randomly divided @ full-term newborns into two groups .


In the experimental group , the newborn received kangaroo care from the mother before , during , and after the @-minute heel blood collection .


In the control group , the heel blood collection was performed under conventional conditions .


The authors compared the two groups ' heart rate , oxygen saturation , facial expressions of pain , and duration of crying .


The two groups had no statistically significant difference in terms of gender , birth weight , mode of delivery , and gestational age ( p > @ ) .


In the seven time periods during the puncture after ten seconds from the beginning and ten seconds after the end , the neonatal heart rates of the two groups changed and statistically significant differences were observed in the duration of heel blood collection , interaction and group factors , as well as in oxygen saturation ( p < @ ) .


During heel blood collection , skin contact between the mother and child can relieve pain , reduce changes in heart rate , improve neonatal heel blood oxygen saturation , and enhance the emotional communication between the mother and child .


To investigate the effects of a suicide prevention programme on the levels of depression , self-esteem , suicidal ideation and spirituality in patients with mental illness .


Instances of suicide have significant correlations with depression , low self-esteem , suicidal ideation and a low level of spirituality in the victims .


Therefore , addressing depression , low self-esteem and suicidal ideation as suicide risk factors and increasing levels of spirituality can constitute an effective programme to prevent suicide among patients with mental illness .


The study was a quasi-experimental study with a nonequivalent control group , nonsynchronised design .


The study sample consisted of @ patients with mental illness who had been admitted to the psychiatric unit in a university hospital in South Korea .


The patients were assigned to control and experimental groups of @ and @ members , respectively .


The suicide prevention programme was conducted with the experimental group over four weeks and included eight sessions ( two per week ) .


The control group received only routine treatments in the hospital .


The experimental group that participated in the programme had significantly decreased mean scores for depression and suicidal ideation compared with the control group .


However , there were no significant differences in the mean scores for self-esteem and spirituality between the groups .


The suicide prevention programme might be usefully applied as a nursing intervention for patients hospitalised in psychiatric wards or clinics where the goals are to decrease depression and suicidal ideation .


Typical treatments for hospitalised patients with mental illness are not enough to prevent suicide .


Intervention for suicide prevention needs to apply an integrated approach .


The suicide prevention programme using an integrated approach is more effective in reducing depression and suicidal ideation in patients with mental illness than applying routine treatments in the hospital .


This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders .


Present care for this population has a limited evidence base , is often open ended , little effective , and expensive .


Recent epidemiological data shows that @ % of the Dutch are affected by mental illness during their life .


About @ % of all patients receiving mental health services ( MHS ) have one or more non-psychotic disorders .


Particularly for this group , long-term treatment and care is poorly developed .


Care As Usual ( CAU ) currently is a form of low-structured treatment/care .


Interpersonal Community Psychiatric Treatment ( ICPT ) is a structured treatment for people with long-term , non-psychotic disorders , developed together with patients , professionals , and experts .


ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study .


Multi-centre cluster-randomized clinical trial : @ professionals will be randomly allocated to either ICPT or CAU for an intervention period of @months , and a follow-up of @months .


@ Patients between @-@ years of age will be included , who have been diagnosed with a non-psychotic psychiatric disorder ( depressive , anxiety , personality or substance abuse disorder ) , have long-term ( > @years ) or high care use ( > @ outpatient contact per week or > @ crisis contacts per year or > @ inpatient admission per year ) , and who receive treatment in a specialized mental health care setting .


The primary outcome variable is quality of life ; secondary outcomes are costs , recovery , general mental health , therapeutic alliance , professional-perceived difficulty of patient , care needs and social contacts .


No RCT , nor cost-effectiveness study , has been conducted on ICPT so far .


The empirical base for current CAU is weak , if not absent .


This study will fill this void , and generate data needed to improve daily mental health care .


Intraabdominal hypertension is a common occurrence , especially in intensive care unit patients , and it has high mortality and morbidity rates .


The onset is commonly insidious and the poor prognosis is attributed to the long delay in diagnosis .


Unfortunately , diagnosis is often delayed until loss of function in the affected tissues has already occurred .


The aim of this study was to determine the predictive value of mean platelet volume ( MPV ) in assessing the risk of intraabdominal hypertension .


Pneumoperitoneum during elective laparoscopic cholecystectomy was used as a model for intraabdominal hypertension .


The study included @ patients who met the inclusion criteria .


MPV evaluations were made at @ distinct times during laparoscopic cholecystectomy based on the actual intraabdominal pressure .


MPV values during preinsufflation , insufflation , and desufflation were @ fL ( range : @ to @ ) , @ fL ( range : @ to @ ) , and @ fl ( range : @ to @ ) , respectively .


A statistically significant increase in MPV values was found during high intraabdominal pressures ( P < @ ) .


A significant decrease in MPV values was also detected with desufflation ( P < @ ) .


Increasing MPV values may reflect increased intraabdominal pressures , which may have a clinical implementation in intraabdominal hypertension .


This study examined the effectiveness of an Internet parenting education and support intervention among mothers with a serious mental illness ( SMI ) .


Sixty mothers diagnosed with a schizophrenia spectrum or mood disorder who had primary/shared custody for a child @ or younger were enrolled in a randomized controlled trial ( RCT ) with two conditions .


The experimental condition involved participation in the online parental education course and a listserv co-moderated by a parent with a mental illness and a mental health professional .


The control condition involved participation in online education healthy lifestyle course .


Standardized measures were used at baseline and @ months to assess outcomes .


Using an intent-to-treat approach , group differences over time were assessed using a two-tailed independent sample t test on all dependent variables , including parental efficacy , skills , coping , support , and stress .


Participation in an online parenting intervention for mothers with a SMI enhanced parenting and coping skills , and decreased parental stress .


No support was found for improved efficacy or support .


This RCT establishes that mothers with a SMI are interested in and capable of receiving online parenting education and support .


Findings demonstrate that an online parenting intervention can improve parenting and coping skills and decrease parental stress .


The literature comparing open and arthroscopic repair for glenohumeral instability is conflicting .


We performed a prospective , expertise-based , randomized clinical trial to compare open shoulder stabilization with arthroscopic shoulder stabilization by measuring quality-of-life outcomes and recurrence rates at two years among patients treated for traumatic anterior shoulder instability .


Computer-generated , variable-block-size , concealed randomization allocated @ patients to either the open-repair group ( n = @ ) or the arthroscopic-repair group ( n = @ ) .


An expertise-based randomization design was employed to avoid a differential bias in terms of physician experience .


Outcomes were measured at baseline , at three and six months postoperatively , and at one and two years postoperatively with use of the Western Ontario Shoulder Instability Index ( WOSI ) and the American Shoulder and Elbow Surgeons ( ASES ) functional outcome scale .


Recurrent instability was also analyzed .


There were no significant differences in outcome scores at baseline .


At two years , seventy-nine patients in the open group and eighty-three patients in the arthroscopic group were available for follow-up .


There was no significant difference in mean WOSI scores between the groups ; the mean WOSI score ( and standard deviation ) for the open group was @ @ ( @ % confidence interval -LSB- CI -RSB- = @ to @ ) , and for the arthroscopic group , @ @ ( @ % CI = @ to @ ) ; p = @ .


There was also no significant difference in mean ASES scores : @ @ ( @ % CI = @ to @ ) for the open group and @ @ ( @ % CI = @ to @ ) for the arthroscopic group ; p = @ .


Recurrence rates at two years were significantly different : @ % in the open group and @ % in the arthroscopic group ( p = @ ) .


Recurrent instability was more likely in patients with a preoperative Hill-Sachs lesion and in male patients who were twenty-five years old and younger .


There was no significant difference in shoulder motion between the groups at two years .


There was no difference between open and arthroscopic repair in terms of patient quality of life .


Open repair resulted in a significantly lower risk of recurrence .


Secondary outcome data from this trial suggest that open surgical repair may be recommended to reduce the risk of recurrent instability in younger male patients with a Hill-Sachs lesion .


To compare the efficacy , safety , and patient 's perception of two prostaglandin E@ application methods for induction of labour .


Above @th weeks of gestation , all women , who were admitted to hospital for induction of labour , were prospectively randomised to intravaginal @ mg or intracervical @ mg irrespective of cervical Bishop score .


The main outcome variables were induction-to-delivery interval , number of foetal blood samples , PDA rate , rate of oxytocin augmentation , rate of vaginal delivery , and patient 's perception using semantic differential questionnaire .


Thirty-nine patients were enrolled in this study .


There was no statistical significant difference between the two groups in regard to perceptions of induction .


The median induction delivery time using intravaginal versus intracervical administration was @ versus @ hours , respectively ( P = @ ) .


No statistically difference between the groups was detected in regard to parity , gestation age , cervical Bishop score , number of foetal blood samples , PDA rate , rate of oxytocin augmentation , and mode of birth .


Irrespective of the cervical Bishop Score , intracervical gel had a shorter induction delivery time without impingement on the women 's perception of induction .


Patients with distributive shock who require high dose vasopressors have a high mortality .


Angiotensin II ( ATII ) may prove useful in patients who remain hypotensive despite catecholamine and vasopressin therapy .


The appropriate dose of parenteral angiotensin II for shock is unknown .


In total , @ patients with distributive shock and a cardiovascular Sequential Organ Failure Assessment score of @ were randomized to either ATII infusion ( N = @ ) or placebo ( N = @ ) plus standard of care .


ATII was started at a dose of @ ng/kg/min , and titrated for a goal of maintaining a mean arterial pressure ( MAP ) of @ mmHg .


The infusion ( either ATII or placebo ) was continued for @ hours then titrated off .


The primary endpoint was the effect of ATII on the standing dose of norepinephrine required to maintain a MAP of @ mmHg .


ATII resulted in marked reduction in norepinephrine dosing in all patients .


The mean hour @ norepinephrine dose for the placebo cohort was @ mcg/min versus @ mcg/min for the ATII cohort ( P = @ ) .


The most common adverse event attributable to ATII was hypertension , which occurred in @ % of patients receiving ATII .


@-day mortality for the ATII cohort and the placebo cohort was similar ( @ % versus @ % , P = @ ) .


Angiotensin II is an effective rescue vasopressor agent in patients with distributive shock requiring multiple vasopressors .


The initial dose range of ATII that appears to be appropriate for patients with distributive shock is @ to @ ng/kg/min .


Asymptomatic and symptomatic malaria during pregnancy has consequences for both mother and her offspring .


Unfortunately , there is insufficient information on the safety and efficacy of most antimalarials in pregnancy .


Indeed , clinical trials assessing antimalarial treatments systematically exclude pregnancy for fear of teratogenicity and embryotoxicity .


The little available information originates from South East Asia while in sub-Saharan Africa such information is still limited and needs to be provided .


A Phase @ , non-inferiority , multicentre , randomized , open-label clinical trial on safety and efficacy of @ ACT when administered during pregnancy was carried out in @ African countries : Burkina Faso , Ghana , Malawi and Zambia .


This is a four arm trial using a balanced incomplete block design .


Pregnant women diagnosed with malaria are randomised to receive either amodiaquine-artesunate ( AQ-AS ) , dihydroartemisinin-piperaquine ( DHA-PQ ) , artemether-lumefantrine ( AL ) , or mefloquine-artesunate ( MQAS ) .


They are actively followed up until day @ post-treatment and then monthly until @-@ weeks post-delivery .


The offspring is visited at the time of the first birthday .


The primary endpoint is treatment failure ( PCR adjusted ) at day @ and safety profiles .


Secondary endpoints included PCR unadjusted treatment failure up to day @ , gametocyte carriage , Hb changes , placenta malaria , mean birth weight and low birth weight .


The primary statistical analysis will use the combined data from all @ centres , with adjustment for any centre effects , using an additive model for the response rates .


This will allow the assessment of all @ possible pair-wise treatment comparisons using all available data .


The strength of this trial is the involvement of several African countries , increasing the generalisability of the results .


In addition , it assesses most ACTs currently available , determining their relative ' - value - ' compared to others .


The balanced incomplete block design was chosen because using all @-arms in each site would have increased complexity in terms of implementation .


Excluding HIV-positive pregnant women on antiretroviral drugs may be seen as a limitation because of the possible interactions between antiretroviral and antimalarial treatments .


Nevertheless , the results of this trial will provide the evidence base for the formulation of malaria treatment policy for pregnant women in sub-Saharan Africa .


The current evidence supports the clinical benefits of late umbilical cord clamping .


These benefits include increased blood volume and total body iron .


Furthermore , delayed cord clamping facilitates the transplantation of stem cells , which helps the development of infant bodily systems .


However , due to concerns related to postpartum hemorrhaging and neonate jaundice , most maternity units still clamp the cord immediately after a child is born .


This study investigates the impact of delaying cord clamping on neonatal jaundice and postpartum hemorrhage .


A randomized , controlled trial was conducted at a regional teaching hospital in northern Taiwan .


One hundred and five healthy nulliparous women at @ weeks of pregnancy were included and allocated randomly to the experiment group ( n = @ ) and the control group ( n = @ ) .


Participants in the experiment group received delayed cord clamping ( DCC ) at @ minutes after delivery .


Participants in the control group received early cord clamping ( ECC ) at around @ minute after delivery .


Clinical measures of the outcomes were measured by the infant transcutaneous bilirubin levels ( TcB ) and postpartum hemorrhage at birth .


A structured questionnaire and biophysical measures were used to collect data on participant demographics , obstetrical information , maternal blood loss at birth , neonate weight and TcB level at hospitalization , and whether or not the infant received phototherapy at @-@ days postpartum .


Overall , there was no significant difference between the two groups in terms of neonatal jaundice , maternal hemorrhage at birth , and phototherapy rates at time of hospitalization and at @-@ days postpartum .


The findings of the present study support that late umbilical cord clamping does not increase the risk of maternal postpartum hemorrhaging or neonate jaundice .


Thus , we suggest that clinicians inform clients during prenatal classes of the benefits of delayed cord clamping and also use current , evidence-based knowledge to dispel client worries regarding the dangers to maternal-neonate health of delayed cord clamping .


Before the introduction of the tension-free vaginal tape ( TVT ) procedure for the treatment of female stress urinary incontinence , the colposuspension operation was regarded as the `` gold standard '' procedure .


The laparoscopic variant of the colposuspension was introduced as a less invasive operation .


The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension ( LCM ) .


A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence .


Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence .


Patient satisfaction was assessed by Patients Global Impression of Improvement , a visual analog scale , and the Urinary Incontinence Severity Score .


Of @ randomized patients , @ underwent the allocated operation .


At the @-year follow-up @ % in the TVT group and @ % in the LCM group could be assessed according to the protocol .


The objective cure rate was significantly higher in the TVT group ( @ % ) than in the LCM group ( @ % ) .


Subjective treatment satisfaction ( completely satisfied with the procedure ) was significantly higher in the TVT group ( @ % ) than in the LCM group ( @ % ) .


By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group .


If cases that were lost to follow-up were regarded as failures , the intension-to-treat analysis found no difference between the groups .


Zinc treatment shortens diarrhea episodes and can prevent future episodes .


In rural Africa , most children with diarrhea are not brought to health facilities .


In a village-randomized trial in rural Kenya , we assessed if zinc treatment might have a community-level preventive effect on diarrhea incidence if available at home versus only at health facilities .


We randomized @ Kenyan villages ( @,@ eligible children ) to receive a @-day course of zinc and two oral rehydration solution ( ORS ) sachets every two months at home and @ villages ( @,@ eligible children ) to receive ORS at home , but zinc at the health-facility only .


Children 's caretakers were educated in zinc/ORS use by village workers , both unblinded to intervention arm .


We evaluated whether incidence of diarrhea and acute lower respiratory illness ( ALRI ) reported at biweekly home visits and presenting to clinic were lower in zinc villages , using poisson regression adjusting for baseline disease rates , distance to clinic , and children 's age .


There were no differences between village groups in diarrhea incidence either reported at the home or presenting to clinic .


In zinc villages ( @,@ children analyzed ) , @ % of diarrheal episodes were treated with zinc , compared to @ % in comparison villages ( @,@ children analyzed , p < @ ) .


There were no differences in ORS use between zinc ( @ % ) and comparison villages ( @ % ) .


Among children with fever or cough without diarrhea , zinc use was low ( < @ % ) .


There was a lower incidence of reported ALRI in zinc villages ( adjusted RR @ , @ % CI @-@ @ ) , but not presenting at clinic .


In this study , home zinc use to treat diarrhea did not decrease disease rates in the community .


However , with proper training , availability of zinc at home could lead to more episodes of pediatric diarrhea being treated with zinc in parts of rural Africa where healthcare utilization is low .


A study was undertaken to test in a subgroup reanalysis of the URICO-ICTUS trial whether uric acid is superior to placebo in improving the functional outcome in patients with acute stroke and hyperglycemia .


Patients were part of the URICO-ICTUS trial , a double-blind study that compared the administration of uric acid versus placebo in stroke patients treated with alteplase within @ hours of onset .


The effect of therapy on the rate of excellent outcome at @ days ( modified Rankin Scale@ ) in each tertile of admission glucose was assessed with multivariate adjusted models in @ of the @ randomized patients who had available pretreatment glucose levels .


The effect of therapy on infarct growth was assessed in @ patients who had longitudinal multimodal brain imaging .


Uric acid was associated with an increased rate of excellent outcome in patients with glucose levels in the upper tertile range ( odds ratio -LSB- OR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- = @-@ @ ) .


However , the effect was not apparent for patients in the middle tertile ( OR = @ , @ % CI = @-@ @ ) or lower tertile of glucose ( OR = @ , @ % CI = @-@ @ ) .


Uric acid therapy was more effective than placebo in limiting infarct growth in the upper tertile range ( Mann-Whitney U test , p = @ ) but not in the middle tertile ( p = @ ) or lower tertile of glucose ( p = @ ) .


Uric acid also proved superior to placebo in reducing infarct growth in patients with early recanalization .


Uric acid therapy was associated with reduced infarct growth and improved outcome in patients with hyperglycemia during acute stroke .


Cocaine pharmacotherapy trials are often confounded by considerable variability in baseline cocaine-use levels , obscuring possible medication efficacy .


Testing the feasibility of using a prerandomization , abstinence-induction protocol , we screened three candidate medications to explore treatment response in patients who did , or did not , achieve abstinence during an extended baseline phase .


Eligible treatment-seeking , cocaine-dependent subjects entered a @-week baseline period ( Phase I ) with high-value abstinence contingent vouchers and two motivational interviewing sessions , followed by a @-week medication trial ( Phase II ) with random assignment stratified on Phase I abstinence status to ( @ ) modafinil ( @mg/d ) , ( @ ) levodopa/carbidopa ( @/@mg/d ) , ( @ ) naltrexone ( @mg/d ) , or ( @ ) placebo .


Treatment consisted of thrice-weekly clinic visits for urine benzoylecgonine testing and weekly cognitive behavioral therapy with contingency management targeting medication compliance .


Of the @ subjects enrolled , @ ( @ % ) completed Phase I , with @ ( @ % ) achieving abstinence , defined a priori as @ consecutive cocaine-negative urines .


Tests of the interaction of each medication ( active versus placebo ) by baseline status ( abstinent versus nonabstinent ) permitted moderator effect analysis .


Overall , baseline abstinence predicted better outcome .


Cocaine-use outcomes for levodopa and naltrexone treatment differed as a function of Phase I abstinence status , with both medications producing benefit in nonabstinent but not baseline-abstinent subjects .


There was no evidence of a moderator effect for modafinil .


The two-phase screening trial demonstrated that subgrouping of patients with respect to baseline abstinence status is feasible and clinically useful for exploring cocaine cessation and relapse-prevention effects of candidate medications .


Prevention of new IgE sensitizations has been described during allergen-specific immunotherapy .


However , prospective data using a preventive approach in very young children who would benefit most are missing .


We initiated a prospective pilot study investigating the safety , immunomodulatory , and sensitization-preventive effect of sublingual immunotherapy ( SLIT ) in mono/oligoclonally sensitized , clinically asymptomatic children @-@ yr of age .


In this double-blinded , randomized , placebo-controlled pilot study , @ mono - / oligosensitized children to house-dust mite or grass pollen were included .


SLIT with the respective source ( n = @ ) or placebo ( n = @ ) was applied .


After dose-up-phase therapy was continued for @ yr .


Parents recorded clinical events , vaccinations , and drug intake in a diary .


Skin prick testing and specific IgE and IgG measurements were recorded at baseline , @ and @ months .


At the same time , allergen-specific proliferation and IL@ - and TGF-dependent Treg function were measured .


Preventive application of SLIT in young children was safe ( no relevant side effects in @,@ single applications ) .


After @ and @ months of treatment , the rate of allergen-specific sensitization ( specific IgE and SPT reactivity ) was comparable in the treatment and the placebo group .


However , verum-treated patients displayed a significant up-regulation of allergen-specific IgG ( p < @ ) .


Furthermore , IL@-dependent inhibition ( p < @ ) was observed in vitro in the treatment group but not in the placebo group .


Preventive SLIT is safe in children @-@ yr of age and induces regulatory mechanisms involving allergen-specific IgG and IL@ .


Based on this pilot study , large-scale trials will need to investigate the modulation of sensitization and clinically relevant allergy .


Radiofrequency ablation ( RFA ) is associated with an excellent outcome in the treatment of great saphenous vein ( GSV ) incompetence .


The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia .


Mechanochemical endovenous ablation ( MOCA ) combines mechanical endothelial damage , using a rotating wire , with the infusion of a liquid sclerosant .


Tumescence anesthesia is not required .


Preliminary experiences with MOCA showed good results and low post-procedural pain .


The MARADONA ( Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation ) trial is a multicenter randomized controlled trial in which @ patients will be randomly allocated to MOCA or RFA .


All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial .


The primary endpoints are anatomic and clinical success at a one-year follow-up , and post-procedural pain .


The secondary endpoints are technical success , complications , operation time , procedural pain , disease-specific quality of life , time taken to return to daily activities and/or work , and cost-efficiency analyses after RFA or MOCA .


Both groups will be evaluated on an intention to treat base .


The MARADONA trial is designed to show equal results in anatomic and clinical success after one year , comparing MOCA with RFA .


In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA , with less post-procedural pain .


Postoperative pain is an unavoidable consequence of open abdominal surgery .


Although cryotherapy , the application of ice to a surgical wound site , has been shown to be effective in reducing postoperative pain in orthopaedic , gynecologic , and hernia operations , it has not been assessed in patients who undergo major open abdominal operations .


We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcomes measure .


Patients undergoing abdominal operations with midline incisions were randomized to receive cryotherapy for a minimum of @ hours in time intervals dictated by patient preference vs no cryotherapy .


The primary outcome of pain relief was assessed with visual analog pain scores ( VAS ) .


The study was powered to detect a clinically significant difference in VAS between the control and cryotherapy group .


Comparisons between groups were measured by Student 's t-test or Mann-Whitney U test for parametric and nonparametric data , respectively .


There were @ patients randomized : @ to the control group and @ to the cryotherapy group .


For the primary measure , mean postoperative pain score on postoperative days ( PODs ) @ and @ after surgery was significantly lower between the control and cryotherapy groups on the visual analog pain scale ( p < @ ) .


Narcotic use was decreased in the cryotherapy group on POD @ by @ morphine equivalents ( p = @ ) .


No statistically significant difference was found between the @ treatment groups with respect to length of hospital stay , pulmonary complications , and wound infection rate in terms of secondary measures .


Ice packs are a simple , cost-effective adjuvant for decreasing postoperative pain and narcotic use in patients undergoing major abdominal operations .


Cognitive behavior therapy for psychosis has been a prominent intervention in the psychological treatment of psychosis .


It is , however , a challenging therapy to deliver and , in the context of increasingly rigorous trials , recent reviews have tempered initial enthusiasm about its effectiveness in improving clinical outcomes .


Acceptance and commitment therapy shows promise as a briefer , more easily implemented therapy but has not yet been rigorously evaluated in the context of psychosis .


The purpose of this trial is to evaluate whether Acceptance and Commitment Therapy could reduce the distress and disability associated with psychotic symptoms in a sample of community-residing patients with chronic medication-resistant symptoms .


This is a single ( rater ) - blind multi-centre randomised controlled trial comparing Acceptance and Commitment Therapy with an active comparison condition , Befriending .


Eligible participants have current residual hallucinations or delusions with associated distress or disability which have been present continuously over the past six months despite therapeutic doses of antipsychotic medication .


Following baseline assessment , participants are randomly allocated to treatment condition with blinded , post-treatment assessments conducted at the end of treatment and at @ months follow-up .


The primary outcome is overall mental state as measured using the Positive and Negative Syndrome Scale .


Secondary outcomes include preoccupation , conviction , distress and disruption to life associated with symptoms as measured by the Psychotic Symptom Rating Scales , as well as social functioning and service utilisation .


The main analyses will be by intention-to-treat using mixed-model repeated measures with non-parametric methods employed if required .


The model of change underpinning ACT will be tested using mediation analyses .


This protocol describes the first randomised controlled trial of Acceptance and commitment therapy in chronic medication-resistant psychosis with an active comparison condition .


The rigor of the design will provide an important test of its action and efficacy in this population .


To evaluate the effectiveness of low-frequency TENS ( LFT ) and high-frequency TENS ( HFT ) in post-episiotomy pain relief .


A randomized , controlled , double-blind clinical trial with placebo composed of @ puerperae with post-episiotomy pain .


TENS was applied for @ minutes to groups : HFT ( @ Hz ; @ s ) , LFT ( @ Hz ; @ s ) , and placebo ( PT ) .


Four electrodes were placed in parallel near the episiotomy and four pain evaluations were performed with the numeric rating scale .


The first and the second evaluation took place before TENS application and immediately after its removal and were done in the resting position and in the activities of sitting and ambulating .


The third and fourth evaluation took place @ and @ minutes after TENS removal , only in the resting position .


Intragroup differences were verified using the Friedman and Wilcoxon tests , and the intergroup analysis employed the Kruskal-Wallis test .


In the intragroup analysis , there was no significant difference in the PT during rest , sitting , and ambulation ( P > @ ) .


In the HFT and LFT , a significant difference was observed in all activities ( P < @ ) .


In the intergroup analysis , there was a significant difference in the resting position in the HFT and LFT ( P < @ ) .


In the sitting activity , a significant difference was verified in the second evaluation in the HFT and LFT ( P < @ ) .


No significant difference was verified among the groups in ambulation ( P < @ ) .


LFT and HFT are an effective resource that may be included in the routine of maternity wards .


To assess the clinical relevance ( functional outcome ) of a @-month allopurinol regimen in patients with high serum uric acid ( SUA ) levels and acute ischemic stroke without considering the changes in SUA levels .


In a randomized , double-blind , controlled study , @ patients ( @ females , @ males ) with acute ischemic stroke who had elevated levels of SUA were included .


They were divided in two @-patient groups to investigate the effect of @ months of an allopurinol ( @ mg/day ) regimen versus placebo on their functional outcome , which was evaluated using a modified Rankin scale .


The overall mean age was @ @ years ( range @-@ ) .


The final favorable functional status ( mRS = @-@ ) was @ ( @ % ) and @ ( @ % ) in the treated and placebo groups , respectively , which was strongly associated with allopurinol consumption ( OR = @ , p = @ ) and age @ years ( OR = @ , p = @ ) in patients with ischemic stroke after adjusting for confounders .


There was no significant difference in death between allopurinol-treated cases ( @ ; @ % ) and placebo-treated ones ( @ ; @ % ; p = @ ) .


Allopurinol treatment was well tolerated and improved the @-month functional status of patients with acute ischemic stroke who had high levels of SUA without considering the decreasing effect of allopurinol on SUA .


To compare new onset dyslipidaemia in live-related renal transplant recipients taking cyclosporine versus tacrolimus after @ months of therapy .


The randomised controlled trial was conducted at the Sindh Institute of Urology and Transplantation ( SIUT ) Karachi , from September @ to April @ , and included @ End Stage Renal Disease patients on maintenance haemodialysis with pre-transplant normal lipid profile .


The patients , who had live-related renal transplant , were randomly allocated to two equal groups using lottery .


Group A received cyclosporine ( @ mg/kg ) and group B was treated with tacrolimus ( @ mg/kg ) .


All patients had pre-transplant fasting lipid profile checked when they were on maintenance haemodialysis and @ months after renal transplantation .


Serum fasting lipid profile was collected by taking @ ml blood by venipuncture after an overnight fast of @-@ hours .


SPSS @ was used for statistical analyses .


Of the @ patients , @ ( @ % ) were males and @ ( @ % ) were females .


The overall mean age was @ + / - @ years , and the mean weight was @ + / - @ kg .


Significant difference was not observed between the two groups regarding age and weight of the patients .


Dyslipidaemia was found in @ ( @ % ) subjects ; @ ( @ % ) in group A and @ ( @ % ) in group B.


There was no statistical difference ( p = @ ) when comparison was done after @ months of therapy .


The occurrence of new onset hyperlipidaemia is similar in renal transplant recipients receiving either cyclosporine or tacrolimus in first @ months post-transplant , but there is room for more research in this field as dyslipidaemia following successful renal transplantation is a frequent and persistent complication .


Postoperative ileus has been considered an inevitable consequence of abdominal surgery .


The aim of the study was to investigate the efficacy of same treatments in resolving postoperative ileus in various surgical approaches .


A total of @ patients underwent abdominal surgery , and was divided into four groups : videolaparoscopic cholecystectomy , laparotomic colo-rectal surgery , laparotomic Hartmann procedure , laparotomic gastric surgery .


In each group , patients received different postoperative treatments : chewing gum , olive oil , both , and water .


Each group was compared with a control group .


In patients who underwent videolaparoscopic cholecystectomy , median postoperative first passage of flatus and stool in the water group was @ and @ hours , respectively ( P = @ , P = @ ) and significantly earlier than in the control group ( median postoperative @ and @ hours ) .


Postoperative stay for the water group was lower ( median day @ , @rd interquartile @ ) compared with control ( median day @ ; @rd interquartile @ , P = @ ) .


In patients who underwent gastric surgery , median postoperative first passage of stool in the olive oil and chewing gum group was @ hours , significantly earlier than in the control ( median postoperative hour @ , P = @ ) .


Median time to first passage of flatus and stool was also earlier in the other groups compared with the control group , though this difference was not significant .


Chewing gum , olive oil or both do not induce a relevant reduction of ileus after surgery .


Water may be a safe and inexpensive option in reducing ileus .


( United States National Institutes of Health , www.clinicaltrial.gov , number NCT@ ) .


Calcium needs are physiologically upregulated during pregnancy and lactation to meet demands of the developing fetus and breastfeeding infant .


Maternal calcium homeostasis is maintained by hormonal adaptive mechanisms , thus , the role of dietary calcium supplementation in altering maternal responses to fetal-infant demand for calcium is thought to be limited .


However , increased calcium absorption is directly related to maternal calcium intake and dietary supplementation has been suggested to prevent transient bone loss associated with childbearing .


In a double-blind , randomized placebo-controlled trial , we randomly assigned @ women in their first trimester of pregnancy to @,@ mg/day calcium ( N = @ ) or placebo ( N = @ ) .


Subjects were followed through @-month postpartum and the effect on urinary cross-linked N-telopeptides ( NTx ) of type I collagen , a specific marker of bone resorption , was evaluated using an intent-to-treat analysis .


Women with a baseline and at least one follow-up measurement ( N = @ ; @ % ) were included .


Subsequent analyses were conducted stratifying subjects by compliance assessed using pill counts .


In random subsets of participants , bone-specific alkaline phosphatase ( BAP ) ( N = @ ) and quantitative ultrasound ( QUS ) ( N = @ ) were also measured .


Calcium was associated with an overall reduction of @ % in urinary NTx relative to placebo ( p < @ ) .


Among those who consumed @ % , @ % , and @ % of pills , respectively , the effect was associated with @ % , @ % , and @ % reductions in bone resorption ( all p < @ ) .


There was no significant effect of calcium on bone formation measured by BAP .


However , by @-month postpartum , those in the calcium group had significantly lower NTx/BAP ratios than those in the placebo group ( p = @ ) indicating a net reduction in bone loss in the supplement group by the end of follow-up .


Among subjects who consumed @ % and @ % of pills , respectively , calcium was also associated with an increase of @ m/s ( p = @ ) and @ m/s ( p = @ ) in radial SOS relative to placebo by @-month postpartum .


Calcium administered during pregnancy and the early postpartum period , to women with intakes around adequacy , was associated with reduced bone resorption and , thus , may constitute a practical intervention to prevent transient skeletal loss associated with childbearing .


The aim of this study was to investigate clinical application of remifentanil in local anesthesia for resection of tumors in functional brain area .


Twenty-four patients were randomly divided into two groups : control group and remifentanil group .


In remifentanil group remifentanil was infused intravenously with micro pump in @-@ @ gkg-@min-@ .


The hemodynamic changes and complications during operation were monitored .


The satisfactory degree for surgical procedure was evaluated .


The surgery of two groups could be completed in a conscious state .


Mean artery pressure ( MAP ) , heart rate ( HR ) in remifentanil group during opening or closing skull or intra - cranial period were significantly lower than control group ( p < @ ) .


There were no conspicuous complications in two groups such as respiratory depression , nausea , vomitting and dysphoria .


Satisfaction rate of remifentanyl group was significantly higher than control group ( p < @ ) .


Awake brain tumor surgery could be completed in rational use of remifentanil on the base of good local anesthesia , and hemodynamics were stable and the patients were well tolerated .


Brivaracetam ( BRV ) is a novel high-affinity synaptic vesicle protein @A ligand in clinical development for the treatment of epilepsy .


This phase III study ( N@ ; NCT@ ) evaluated the efficacy and safety/tolerability of BRV ( @ , @ , and @ mg/day ) compared with placebo ( PBO ) in patients aged @-@ years with uncontrolled focal seizures with/without secondary generalization , despite treatment with one to two concomitant antiepileptic drugs at a stable and optimal dosage .


This was a double-blind , randomized , placebo-controlled trial conducted across Europe and India .


Eligible patients had two or more focal seizures/month for @ months prior to screening and eight or more focal seizures during the @-week prospective baseline .


Concomitant use of levetiracetam was limited to @ % of randomized patients .


Patients were randomized ( @:@:@:@ ) to BRV @ , @ , @ mg/day or PBO with no up-titration for @ weeks , followed by down-titration or entry into a long-term follow-up study .


The primary efficacy end point was percent reduction over PBO in baseline-adjusted focal seizure frequency/week over the @-week treatment period .


Comparison of BRV with PBO was sequential to control for multiplicity ( @ , @ , @ mg/day ) , and thus required BRV to demonstrate superiority over PBO at @ mg/day to meet the primary efficacy end point .


Secondary efficacy variables were median percent reduction from baseline in focal seizure frequency/week , @ % responder rate , and seizure freedom ( all seizure types ) .


Safety assessments included treatment-emergent adverse events ( TEAEs ) .


Of @ randomized patients , @ were included in the intent-to-treat ( ITT ) and safety populations .


Overall , @ ( @ % ) of @ patients completed the study ( BRV : @ % , @ % , and @ % for @ , @ , and @ mg/day , respectively ; PBO : @ % ) and @ ( @ % ) of @ patients continued into long-term follow-up studies ( BRV : @ % , @ % , and @ % for @ , @ , and @ mg/day , respectively ; PBO : @ % ) .


The study did not meet its primary efficacy end point based on the predefined sequential testing strategy .


Indeed , percent reduction over PBO in baseline-adjusted focal seizure frequency/week ( primary efficacy analysis ) was @ % ( p = @ ) , @ % ( p = @ ) , and @ % ( p = @ ) for BRV @ , @ , and @ mg/day , respectively .


Median percent reduction from baseline in focal seizure frequency/week was @ % ( p = @ ) , @ % ( p = @ ) , and @ % ( p = @ ) for BRV @ , @ , and @ mg/day , respectively , compared with @ % for PBO .


Responder rates ( @ % ) were @ % ( p = @ ) , @ % ( p = @ ) , and @ % ( p = @ ) for BRV @ , @ , and @ mg/day , respectively , compared with @ % for PBO .


Complete seizure freedom was reported by @/@ , @/@ , and @/@ patients on BRV @ , @ , and @ mg/day , respectively , compared with @/@ on PBO .


The incidence of TEAEs was higher for BRV @ ( @/@ , @ % ) , @ ( @/@ , @ % ) , and @ mg/day ( @/@ , @ % ) than PBO ( @/@ , @ % ) ; most TEAEs were mild or moderate in severity .


The most frequently reported TEAEs in the BRV groups were headache , somnolence , dizziness , and fatigue .


In this study of adjunctive BRV ( @-@ mg/day ) in adults with uncontrolled focal seizures , the primary efficacy analysis based on the @ mg/day dose was not statistically significant .


However , BRV @ mg/day reduced baseline-adjusted focal seizure frequency/week by @ % over PBO , achieving statistical significance ( p = @ ) .


Secondary efficacy analyses ( percent reduction from baseline in focal seizure frequency/week , @ % responder rate ) provided supportive evidence for the efficacy of BRV @ mg/day .


BRV @-@ mg/day was well tolerated without up-titration , with a high completion rate .


Medication errors related to hospital discharge result in rehospitalization and emergency department ( ED ) visits , yet no systematic approach has been implemented nationally to decrease these medication errors .


Pharmacist involvement during postdischarge transitions of care may be an important strategy to prevent and correct medication discrepancies and reduce costly rehospitalization and ED visits .


This prospective , randomized , open-label , pilot study evaluated the effect of a pharmacy clinic visit focused on medication reconciliation and patient education after hospital discharge on the incidence of rehospitalization and ED visits and the resolution of medication discrepancies .


Of the @ subjects included in the study , @ ( @ % ) had medication discrepancies identified at discharge .


Fifty percent of medication discrepancies were resolved in subjects randomized to the pharmacist intervention arm compared with @ % in the usual care arm ( P = @ ) .


Patients randomized to the intervention arm had significantly lower rates of the primary composite outcome of @-day rehospitalization and ED visits compared with the usual care arm ( @ % vs @ % , P < @ ) .


A pharmacist-driven intervention focused on patient education and medication reconciliation after discharge improved medication use and reduced health care resource utilization in this pilot study .


Prostate-specific antigen ( PSA ) screening is controversial .


A community jury allows presentation of complex information and may clarify how participants view screening after being well-informed .


We examined whether participating in a community jury had an effect on men 's knowledge about and their intention to participate in PSA screening .


Random allocation to either a @-day community jury or a control group , with preassessment , postassessment and @-month follow-up assessment .


Participants from the Gold Coast ( Australia ) recruited via radio , newspaper and community meetings .


Twenty-six men aged @-@ years with no previous diagnosis of prostate cancer .


The control group ( n = @ ) received factsheets on PSA screening .


Community jury participants ( n = @ ) received the same factsheets and further information about screening for prostate cancer .


In addition , three experts presented information on PSA screening : a neutral scientific advisor provided background information , one expert emphasised the potential benefits of screening and another expert emphasised the potential harms .


Participants discussed information , asked questions to the experts and deliberated on personal and policy decisions .


Our primary outcome was change in individual intention to have a PSA screening test .


We also assessed knowledge about screening for prostate cancer .


Analyses were conducted using intention-to-treat .


Immediately after the jury , the community jury group had less intention-to-screen for prostate cancer than men in the control group ( effect size = -@ SD , p = @ ) .


This was sustained at @-month follow-up .


Community jury men also correctly identified PSA test accuracy and considered themselves more informed ( effect size = @ SD , p < @ ) .


Evidence-informed deliberation of the harms and benefits of PSA screening effects men 's individual choice to be screened for prostate cancer .


Community juries may be a valid method for eliciting target group input to policy decisions .


Mobile-phone-based text ( SMS ) messaging is an effective method for delivering smoking cessation assistance ; however , little is known about optimal program use .


This paper reports on the use of @ forms of interaction ( reporting changes in quit status and emergency help ) among users of QuitTxt , an interactive , automated text messaging advice program .


We examined preferences for messaging intensity , duration of use , and their associations with short-term cessation outcome or perceived helpfulness .


QuitTxt was offered during participation in a previously reported randomized controlled trial and was activated by @ smokers or recent quitters , of whom @ used it to a criterion level .


Outcome data ( quit attempts , @-day point prevalence abstinence , and perceived helpfulness ) were collected @ month after first use .


Most ( @ % ) accepted the default of @-@ messages per day , and median use duration was @ days .


Half ( @ % ) appeared to miss reporting at least @ status change , with relapses less likely to be reported than quit progression .


Emergency help was used by @ % of those eligible for it ; emergency help was used more frequently among those with recent quit experience and lower nicotine dependence .


Use of emergency help was unrelated to short-term cessation outcome .


The most notable finding is the variability in use .


Some users complied fully with the requirement to report status changes , while even among those who did not , many found QuitTxt to be very helpful , suggesting that perfect congruence between message content and quit status is not essential .


The use of emergency help functionality was relatively rare but was appreciated .


To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake .


This randomized controlled trial at two university medical centers enrolled @ overweight or obese adults with type @ diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) .


Relative weight loss was @ % ( @ % CI @-@ @ % ) , @ % ( @-@ @ % ) , and @ % ( @-@ @ % ) for the lower fat , lower carbohydrate , and UC groups ( P < @ intervention effect ) .


Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at @ year ( fasting glucose @ -LSB- @ % CI @-@ -RSB- vs. @ -LSB- @-@ -RSB- mg/dL , P = @ ; hemoglobin A@c @ % -LSB- @-@ @ % -RSB- vs. @ % -LSB- @-@ @ % -RSB- or @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- mmol/mol , P = @ ; triglycerides @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- mg/dL , P < @ ) .


The lower versus higher carbohydrate groups maintained lower hemoglobin A@c ( @ % -LSB- @ % CI @-@ @ % -RSB- vs. @ % -LSB- @-@ @ % -RSB- or @ -LSB- @-@ -RSB- vs. @ -LSB- @-@ -RSB- mmol/mol ) at @ year ( P = @ ) .


The weight loss program resulted in greater weight loss and improved glycemic control in type @ diabetes .


Recurrent miscarriage is a major women 's health problem .


Aspirin and heparin have been shown to have potentially beneficial effects on trophoblast implantation .