However , few published data on this issue are available from developing countries .


An open clinical trial was conducted at the Department of Obstetrics and Gynecology at Misurata Teaching Hospital in Libya from January @ to December @ to investigate the effects of treatment with low dose aspirin ( LDA ) versus treatment with low-molecular-weight-heparin ( LMWH ) in combination with LDA on patients with a history of recurrent miscarriages .


A total of @ women were enrolled in the study .


Women were eligible for the study if they had a history of three or more consecutive miscarriages .


Participants were randomly assigned to receive either LDA ( @ mg daily ) alone or a combination of LDA and LMWH ( @ women per treatment group ) .


The primary outcomes were the rate of miscarriages and live births for each group .


Compared with the group who received LDA alone , the combination group had a significantly lower number of miscarriages ( @/@ -LSB- @ % -RSB- vs. @/@ -LSB- @ % -RSB- , P < @ ) and had a significantly higher number of live births ( @/@ -LSB- @ % -RSB- vs. @/@ -LSB- @ % -RSB- , P < @ ) .


Two preterm infants in the LDA group and three in the combination group were admitted to the neonatal intensive care unit .


There were no significant differences in the mean ( SD ) birth weights of neonates born in either group ( @ @ vs. @ @ g for the LDA and combination groups , respectively , P = @ ) .


There were no congenital abnormalities detected in either group .


The combination of LDA and LMWH is better than LDA alone for the maintenance of pregnancy in patients with recurrent first trimester miscarriage .


Because heart rate affects ventricular filling , the aim of the present study was to assess the effects of increasing heart rate and tidal volume on stroke volume variability to determine whether this dynamic index is heart-rate dependent .


Prospective , randomized study .


Single university hospital .


Eighteen vascular surgery patients having general anesthesia and endotracheal intubation with an arterial catheter connected to the Vigileo FloTrac system ( Edwards Lifesciences , Irvine , CA ) and a transesophageal atrial pacemaker ( CardioComman Inc , Tampa , FL ) .


A @ @ factorial study of changes in heart rate ( @ bpm and @ bpm ) and tidal volume ( @ mL/kg and @ mL/kg ) .


With tidal volume at @ mL/kg , increasing heart rate from @ mL/kg to @ bpm caused stroke volume variability to increase from @ % @ % to @ % @ % ( p < @ ) , and with tidal volume at @ mL/kg , increasing heart rate from @ mL/kg to @ bpm caused stroke volume variability to increase from @ % @ % to @ % @ % ( p < @ ) .


In comparison , increasing tidal volume from @ mL/kg to @ mL/kg produced a significantly greater effect on stroke volume variability than increasing heart rate .


Stroke volume variability is sensitive to increases in heart rate in addition to tidal volume .


Increasing heart rate caused stroke volume variability to increase significantly , although not to the same magnitude as increasing tidal volume .


When using dynamic volume indices , clinicians should be aware of increases in heart rate , although its clinical impact may be relatively minor compared with changes in tidal volume .


To determine the effect of oral acetazolamide on lowering the peak and duration of intraocular pressure ( IOP ) rise in glaucoma and glaucoma suspect patients , following intravitreal injection of ranibizumab for neovascular age-related macular degeneration .


The study was an open-label , parallel , randomised , controlled trial ( EudraCT Number : @-@-@ ) .


Twenty-four glaucoma or glaucoma suspect patients received either @mg acetazolamide or no treatment @-@min before @ mg ranibizumab .


The primary outcome measure was the difference in IOP immediately after injection ( T@ ) and @ , @ , and @min following injection .


ANCOVA was used to compare groups , adjusting for baseline IOP .


The study was powered to detect a @-mmHg difference at T@ .


The IOP at T@ was @ mmHg higher in the non-treated group ( mean @ mmHg , range ( @-@mmHg ) ) compared with the treated group ( mean @ mmHg , range ( @-@mmHg ) ) , but was not statistically significant after adjusting for baseline IOP ( P = @ ) .


At @min , IOP was @ mmHg higher in the non-treated group ( mean @ mmHg , range ( @-@mmHg ) ) compared with the treated group ( mean @ mmHg , range ( @-@mmHg ) ) .


This was statistically significant after adjusting for baseline IOP ( P = @ ) .


Although the primary end points were not reached , @mg oral acetazolamide , @-@min before intravitreal injection , results in a statistically significant reduction in IOP at @O min post injection .


Prophylactic treatment may be considered as an option to minimise neuro-retinal rim damage in high-risk glaucoma patients who are most vulnerable to IOP spikes and undergoing repeated intravitreal injections of ranibizumab .


The effects of an anticholinergic or antidiuretic agent as add-on therapy to an alpha-blocker for lower urinary tract symptoms ( LUTS ) according to a voiding diary in @ days are unknown .


We prospectively investigated the efficacy of an anticholinergic or antidiuretic agent as add-on therapy for nocturia in men previously treated with an alpha-blocker for LUTS .


Patients were randomly subdivided into two groups .


All patients had a @-week washout .


Group A had alpha-blocker for @ weeks , then an alpha-blocker plus an anticholinergic agent for @ weeks , and , finally , @ weeks of an alpha-blocker plus an antidiuretic agent .


Group B had an alpha-blocker for @ weeks , then an alpha-blocker plus an antidiuretic agent for @ weeks , and , finally , @ weeks of an alpha-blocker plus an anticholinergic agent .


In both groups , patients were subdivided into nocturnal polyuria , decreased nocturnal bladder capacity ( NBC ) , or nocturia by both causes subgroups .


A @-day voiding diary , total International Prostate Symptom Score ( IPSS ) , IPSS sub-scores , Overactive Bladder Symptom Score , uroflowmetry , and post-void residual urine volume , were assessed at baseline , and at @ , @ , and @ weeks .


A total of @ patients completed the study .


During treatment , the changes from baseline in total IPSS and IPSS sub-scores were significantly decreased at @ weeks and were maintained for @ weeks .


In the nocturnal polyuria subgroup of Groups A and B , the number of episodes of nocturia in @ days , nocturnal urine volume , and nocturnal index were significantly decreased using an alpha-blocker plus an antidiuretic agent .


In the decreased NBC subgroup of Groups A and B , IPSS storage sub-score , Overactive Bladder Symptom Score , number of episodes of nocturia in @ days , number of episodes of urgency in @ days , and NBC index were all significantly decreased using an alpha-blocker plus an anticholinergic agent .


An anticholinergic agent or antidiuretic agent as an add-on therapy in men previously treated with an alpha-blocker improves nocturia including LUTS .


The negative effect of hypoxia on cognitive function has been well described .


However , less has been published regarding cognitive dysfunction resulting from hypoxia produced by exposure to different altitudes .


We measured short-term and working memory capacity ( Digit Span tasks ) , cognitive flexibility and selective attention ( Word-Color Stroop Task ) , and executive functioning ( Trailmaking A and B tests ) at baseline and simulated altitudes equal to @,@ ft ( @ m ) and @,@ ft ( @ m ) in order to obtain more information about the role of altitude exposure on cognitive tasks important for optimal functioning in the aviation environment .


Behavioral observations indicated that hypoxia was induced at different simulated altitudes .


Marked declines in cognitive performance were also observed for all tests at @,@ ft , with scores indicating greater impairment in this condition relative to others .


Subjects also showed greater impairment when scores obtained in the @,@-ft condition were compared to baseline , although the effects were not as clearly defined relative to the @,@ vs. baseline contrasts .


The results of this study suggest that electronic versions of these tests may be useful in screening for acute symptoms of hypoxia and could provide insight into how discrete cognitive processes become impaired with oxygen deprivation at various altitudes .


Given that these tests also assess neuropsychological functioning , our results allow for inferences to be made about the effects of hypoxia on human brain functioning .


Recent years have seen remarkable progress in cancer therapy , although treatment-induced adverse reactions and complications are not uncommon .


Approximately @ % of patients undergoing chemotherapy for cancer experience adverse reactions in the oral cavity , with nearly half of them developing severe oral mucositis that necessitates postponing therapy and/or changing the drug dosage .


The objective of this study was to assess the usefulness of prophylactic professional oral health care ( POHC ) for preventing mucositis in patients undergoing chemotherapy .


Twenty-six female patients scheduled for chemotherapy for breast cancer were included in this study and randomized to the self-care or POHC groups .


Assessment parameters included oral cavity photographs , plaque control records , Saxon test scores , Oral Assessment Guide scores , and grading using the Common Terminology Criteria for Adverse Events .


Beginning before surgery and continuing through the completion of chemotherapy , the POHC patient group received weekly professional oral health care , including scaling , professional cleaning of the tooth surfaces , brushing instructions , and nutritional and lifestyle guidance .


More patients in the self-care group developed oral mucositis than in the POHC group .


The Oral Assessment Guide score , which was used as an index of oral mucositis , was also significantly lower in the POHC group .


Based on the Oral Assessment Guide and plaque control records , there was almost no deterioration of the oral environment in the POHC group , whereas deterioration was observed in the self-care group .


These findings demonstrate the efficacy of regular POHC in reducing the risk of oral mucositis in breast cancer patients undergoing chemotherapy .


To compare the superficial incisional surgical site infection ( SSI ) rate after cesarean section ( CS ) in obese women using subcuticular versus interrupted skin suturing .


The current randomized controlled clinical trial was conducted at Ain Shams University Maternity Hospital .


Obese non-diabetic women who underwent elective CS were randomized into two groups : group I included women who had their skin closed with interrupted mattress suture using non-absorbable polypropylene , and group II included women who had their skin closed with subcuticular suture using the same suture material .


Primary outcome measure was superficial incisional SSI and secondary outcome measures were skin closure time , postoperative pain assessed by ten-point visual analog scale ( VAS ) and short-term cosmetic wound outcome according to the Stony Brook Scar Evaluation Scale ( SBSES ) .


A total of @ obese women were finally analyzed .


Group II ( n = @ ) was associated with higher incidence of superficial incisional SSI .


There were nine cases ( @ % ) compared to three cases ( @ % ) in group I ( n = @ ) ; however , this difference was statistically not significant ( P = @ ) .


Skin closure time was significantly prolonged in group I ( @ @ min versus @ @ min , respectively , P < @ ) .


Postoperative pain was significantly lower in group I and the mean VAS in group I was @ @ versus @ @ in group II ( P = @ ) .


Using SBSES , group II had mean score @ @ , while group I had mean score @ @ .


This was statistically significant ( P < @ ) , which means a better cosmetic outcome in group II .


Subcuticular skin closure during CS for non-diabetic obese women was significantly associated with better short-term cosmetic outcome , less skin closure time , yet , with slightly higher risk of superficial incisional SSI and significantly more postoperative pain .


Adherence to pre-exposure prophylaxis ( PrEP ) is critical for efficacy .


Antiretroviral concentrations are an objective measure of PrEP use and correlate with efficacy .


Understanding patterns and correlates of drug detection can identify populations at risk for nonadherence and inform design of PrEP adherence interventions .


Blood antiretroviral concentrations were assessed among active arm participants in iPrEx , a randomized placebo-controlled trial of emtricitabine/tenofovir in men who have sex with men and transgender women in @ countries .


We evaluated rates and correlates of drug detection among a random sample of @ participants at week @ and a longitudinal cohort of @ participants through @ weeks of follow-up .


Overall , @ % of participants ( @ % confidence interval : @ to @ ) tested at week @ had drug detected .


Drug detection was associated with older age and varied by study site .


In longitudinal analysis , @ % never had drug detected , @ % always had drug detected , and @ % had an inconsistent pattern .


Overall detection rates declined over time .


Drug detection at some or all visits was associated with older age , indices of sexual risk , including condomless receptive anal sex , and responding `` do n't know '' to a question about belief of PrEP efficacy ( @-@ scale ) .


Distinct patterns of study product use were identified , with a significant proportion demonstrating no drug detection at any visit .


Research literacy may explain greater drug detection among populations having greater research experience , such as older men who have sex with men in the United States .


Greater drug detection among those reporting highest risk sexual practices is expected to increase the impact and cost-effectiveness of PrEP .


In patients with chronic kidney disease ( CKD ) hyperuricemia is common .


Evidence that hyperuricemia might also play a causal role in vascular disease , hypertension and progression of CKD is accumulating .


Therefore , we studied the association between baseline uric acid ( UA ) levels and the rate of decline in renal function and time until start of dialysis in pre-dialysis patients .


Data from the PREPARE-@ study were used .


The PREPARE-@ study is an observational prospective cohort study including incident pre-dialysis patients with CKD stages IV-V in the years between @ and @ .


Patients were followed for a median of @ months until start of dialysis , kidney transplantation , death , or censoring .


Main outcomes were the change in the rate of decline in renal function ( measured as estimated glomerular filtration rate ( eGFR ) ) estimated using linear mixed models , and time until start of dialysis estimated using Cox proportional hazards models .


In this analysis @ patients were included with a baseline UA level ( mean ( standard deviation ( SD ) ) of @ ( @ ) mg/dl ) and a mean decline in renal function of -@ ( @ % confidence interval ( CI ) , -@ ; -@ ) ml/min/@ @ m@/year .


The change in decline in GFR associated with a unit increase in UA at baseline was -@ ( @ % CI -@ ; @ , p = @ ) ml/min/@ @ m@/year .


Adjusted for demography , comorbidities , diet , body mass index ( BMI ) , blood pressure , lipids , proteinuria , diuretic and/or allopurinol usage the change in decline in eGFR did not change .


The hazard ratio ( HR ) for starting dialysis for each mg/dl increase in UA at baseline was @ ( @ % CI , @ ; @ , p = @ ) .


After adjustment for the same confounders the HR became significant at @ ( @ % CI , @ ; @ , p = @ ) , indicating an earlier start of dialysis with higher levels of UA .


Although high UA levels are not associated with an accelerated decline in renal function , a high serum UA level in incident pre-dialysis patient is a risk factor for an earlier start of dialysis .


A higher protein to carbohydrate ratio in the diet may potentiate weight loss , improve body composition and cardiometabolic risk , including glucose homeostasis in adults .


The aim of this randomised control trial was to determine the efficacy of two structured lifestyle interventions , differing in dietary macronutrient content , on insulin sensitivity and body composition in adolescents .


We hypothesised that a moderate-carbohydrate ( @-@ % of energy ) , increased-protein ( @-@ % ) diet would be more effective than a high-carbohydrate diet ( @-@ % ) , moderate-protein ( @ % ) diet in improving outcomes in obese , insulin resistant adolescents .


Obese @-@ year olds with either pre-diabetes and/or clinical features of insulin resistance were recruited at two hospitals in Sydney , Australia .


At baseline adolescents were prescribed metformin and randomised to one of two energy restricted diets .


The intervention included regular contact with the dietician and a supervised physical activity program .


Outcomes included insulin sensitivity index measured by an oral glucose tolerance test and body composition measured by dual-energy x-ray absorptiometry at @months .


Of the @ adolescents recruited , @ ( @ % ) completed the intervention .


BMI expressed as a percentage of the @th percentile decreased by @ % -LSB- @ % CI : -@ to -@ -RSB- , ISI increased by @ -LSB- @ % CI : @ to @ -RSB- and percent body fat decreased by @ % -LSB- @ % CI : -@ to -@ -RSB- .


There were no significant differences in outcomes between diet groups at any time .


When treated with metformin and an exercise program , a structured , reduced energy diet , which is either high-carbohydrate or moderate-carbohydrate with increased-protein , can achieve clinically significant improvements in obese adolescents at risk of type @ diabetes .


Oxidative stress and inflammation can be altered by dietary factors in various species .


However , little data are available in true carnivorous species such as domestic cats .


As numerous anti-inflammatory and anti-oxidative additives become available and might be of use in cats with chronic low-grade inflammatory diseases , the current study aimed to develop a model of diet-induced inflammation by use of two opposite diets .


It was hypothesized that a high fat diet enhanced in n-@ PUFA and with lower concentrations of antioxidants would evoke inflammation and oxidative stress in domestic cats .


Sixteen healthy adult cats were allocated to two groups .


One group received a moderate fat diet , containing pork lard and salmon oil ( AA : ( EPA+DHA ) ratio @ ) ( MFn-@ ) , while the other group was fed a high fat diet , containing pork lard and chicken fat ( AA : ( EPA+DHA ) ratio @ ) ( HFn-@ ) for @weeks .


Prior to and @ , @ , @ , @ , @ and @weeks after starting the testing period , blood samples were collected .


Erythrocytic fatty acid profile showed clear alterations in accordance to the dietary fatty acid profile .


Serum thiobarbituric acid reactive substances was higher when fed MFn-@ compared to the HFn-@ , suggesting augmented oxidative stress .


This was associated with a reduced serum vitamin E status , as serum - tocopherol concentrations were lower with MFn-@ , even with higher dietary levels of vitamin E. Serum cytokine and serum amyloid A concentrations were not influenced by diet .


These results point towards a resistance of cats to develop dietary fat-induced inflammation , but also suggest a high susceptibility to oxidative stress when fed a fish oil-supplemented diet even with moderate fat level and additional vitamin E.


It is still unknown how best to maintain effects of exercise programmes in COPD in the long-term .


We present the long-term effects of a community-based exercise programme incorporated in a self-management programme , compared to a self-management programme only in patients with COPD .


All included patients participated in four self-management sessions .


Additionally , patients in the intervention group participated in an @-month community-based exercise programme led by physiotherapists .


Patients trained three times/week for six months and two times/week during the subsequent five months .


To encourage a behavioural change towards exercise , one of these weekly training sessions was home-based ( unsupervised ) .


No formal exercise training was offered to intervention patients in the second year .


The intervention was assigned to @ patients , and the control condition to @ patients .


@ % and @ % of the intervention and control group , respectively , completed @ months follow-up .


Modified intention-to-treat analyses were performed .


Although statistically significant after @ months ( @ m ( @ % CI : @-@ @ ) ) , the between-group difference on maximal exercise capacity was not statistically significant after @ months ( @ m ( @ % CI : -@ to @ ) .


Nevertheless , the between-group difference in daily physical activity was maintained after @ months ( @ steps/day ( @ % CI : @-@ ) ) .


A beneficial effect was also found on CRQ dyspnoea score but not on other CRQ domains , CCQ and HADS .


Our intervention was effective in achieving a behavioural change reflected by a sustained increase in daily physical activity , not accompanied by a sustained increase in maximal exercise capacity after two years of follow-up ( ISRCTN@ ) .


Tension-type headache ( TTH ) is the most common type of primary headache however there is no clear evidence as to which specific treatment is most effective or whether combined treatment is more effective than individual treatments .


To assess the effectiveness of manual therapy techniques , applied to the suboccipital region , on aspects of disability in a sample of patients with tension-type headache .


Randomized Controlled Trial .


Specialized centre for headache treatment .


Seventy-six ( @ women ) patients ( age : @ @ years ) with episodic chronic TTH .


Patients were randomly divided into four treatment groups : @ ) suboccipital soft tissue inhibition ; @ ) occiput-atlas-axis manipulation ; @ ) combined treatment of both techniques ; @ ) control .


Four sessions were applied over @ weeks and disability was assessed before and after treatment using the Headache Disability Inventory ( HDI ) .


Headache frequency , severity and the functional and emotional subscales of the questionnaire were assessed .


Photophobia , phonophobia and pericranial tenderness were also monitored .


Headache frequency was significantly reduced with the manipulative and combined treatment ( P < @ ) , and the severity and functional subscale of the HDI changed in all three treatment groups ( P < @ ) .


Manipulation treatment also reduced the score on the emotional subscale of the HDI ( P < @ ) .


The combined intervention showed a greater effect at reducing the overall HDI score compared to the group that received suboccipital soft tissue inhibition and to the control group ( both P < @ ) .


In addition , photophobia , phonophobia and pericranial tenderness only improved in the group receiving combined therapy ( P < @ ) .


When given individually , suboccipital soft tissue inhibition and occiput-atlas-axis manipulation resulted in changes in different parameters related to the disability caused by TTH .


However , when the two treatments were combined , effectiveness was noted for all aspects of disability and other symptoms including photophobia , phonophobia and pericranial tenderness .


Although individual manual therapy treatments showed a positive change in headache features , measures of photophobia , photophobia and pericranial tenderness only improved in the group that received the combined treatment suggesting that combined treatment is the most appropriate for symptomatic relief of TTH .


The evaluation of the safety and preliminary efficacy of @ g ocriplasmin intravitreal injection in patients with focal vitreomacular adhesion ( VMA ) and exudative age-related macular degeneration ( AMD ) .


Randomized , sham-injection controlled , double-masked , multicenter , phase II trial .


A total of @ patients with VMA and wet AMD were randomized @:@ to receive @ g ocriplasmin intravitreal injection or sham injection .


Study treatment was administered in the mid-vitreous cavity by injection .


Post-treatment safety and efficacy assessments were made at baseline and on days @ , @ , and @ and months @ , @ , and @ after injection .


Secondary efficacy end points were exploratory in nature .


The safety and tolerability of ocriplasmin were evaluated .


The primary efficacy end point was the proportion of patients with VMA release at day @ after injection .


Secondary end points reported included VMA release over time , total posterior vitreous detachment ( PVD ) , change in visual acuity from baseline , and number of anti-vascular endothelial growth factor ( VEGF ) injections .


The safety of ocriplasmin in patients with VMA and wet AMD was shown to be comparable to the known safety profile , with the majority of adverse events in the study eye occurring in the first @ days after study treatment .


A greater proportion of patients achieved VMA resolution and total PVD at month @ with ocriplasmin compared with sham treatment .


There was a decrease in the number of anti-VEGF injections with ocriplasmin at month @ compared with the sham group , although no differences in visual acuity were observed .


Ocriplasmin treatment in this population seems to be generally safe and well tolerated and resulted in more patients achieving VMA resolution and PVD with less anti-VEGF use compared with sham treatment .


At present , it is unknown whether the use of nutrient-rich dairy proteins improves the markers of sarcopenia syndrome .


Therefore , our proposal was to investigate whether adding @ g of ricotta cheese daily would improve skeletal muscle mass , handgrip strength , and physical performance in non-sarcopenic older subjects .


This was a single-blind randomized clinical trial that included two homogeneous , randomized groups of men and women over @ years of age .


Participants in the intervention group were asked to consume their habitual diet but add @ g of ricotta cheese ( IG/HD + RCH ) , while the control group was instructed to consume only their habitual diet ( CG/HD ) .


Basal and @-week follow-up measurements included appendicular skeletal muscle mass ( ASMM ) by dual-energy X-ray absorptiometry , handgrip strength by a handheld dynamometer , and physical performance using the short physical performance battery ( SPPB ) and the stair-climb power test ( SCPT ) .


The main outcomes were relative changes in ASMM , strength , SPPB , and SCPT .


ASMM increased in the IG/HD + RCH ( @ kg ) , but decreased in the CG/HD ( -@ ) .


The relative change between groups was statistically significant ( P = @ ) .


The relative change in strength in both groups was negative , but the loss of muscle strength was more pronounced in CG/HD , though in this regard statistical analysis found only a tendency ( P = @ ) .


The relative change in the balance-test scores was positive for the IG/HD + RCH , while in the CG/HD it was negative , as those individuals had poorer balance .


In this case , the relative change between groups did reach statistical significance .


The addition of @ g of ricotta cheese improves ASMM and balance-test scores , while attenuating the loss of muscle strength .


These results suggest that adding ricotta cheese to the habitual diet is a promising dietetic strategy that may improve the markers of sarcopenia in subjects without a pronounced loss of ASMM or sarcopenia .


The heel-lance ( HL ) method for blood collection from the newborn is controversial for the pain it causes .


This is the first randomized controlled trial on the management and reduction of pain using the music of Wolfgang Amadeus Mozart ( `` Sonata K. @ '' ) in premature infants hospitalized in a neonatal intensive care unit ( NICU ) .


This study has compared nonpharmacological techniques with standard procedure for reducing pain during HL procedure .


Thirty-five premature infants were enrolled , each for @ HL procedures , of which each was randomized to @ of the @ study arms .


Arms were then compared in terms of the Premature Infant Pain Profile ( PIPP ) changes by analysis of variance ( ANOVA ) .


One hundred five HL procedures were available for analysis ( @ standard procedure , @ music , @ glucose ) .


Median baseline PIPP was @ , and median PIPP after the HL procedure was @ .


PIPP scale change was +@ in the control arm , +@ in the glucose arm , +@ in the music arm ( p = @ ) .


Both glucose and music were safe and effective in limiting pain increase when compared to standard procedure in HL procedures in preterm infants .


Glutamate excitotoxicity might contribute to the pathophysiology of amyotrophic lateral sclerosis .


In animal models , decreased excitatory aminoacid transporter @ ( EAAT@ ) overexpression delays disease onset and prolongs survival , and ceftriaxone increases EAAT@ activity .


We aimed to assess the safety and efficacy of ceftriaxone for amyotrophic lateral sclerosis in a combined phase @ , @ , and @ clinical trial .


This three-stage randomised , double-blind , placebo-controlled study was done at @ clinical sites in the USA and Canada between Sept @ , @ , and July @ , @ .


Eligible adult patients had amyotrophic lateral sclerosis , a vital capacity of more than @ % of that predicted for age and height , and symptom duration of less than @ years .


In stages @ ( pharmacokinetics ) and @ ( safety ) , participants were randomly allocated ( @:@ ) to ceftriaxone ( @ g or @ g per day ) or placebo .


In stage @ ( efficacy ) , participants assigned to ceftriaxone in stage @ received @ g ceftriaxone , participants assigned to placebo in stage @ received placebo , and new participants were randomly assigned ( @:@ ) to @ g ceftriaxone or placebo .


Participants , family members , and site staff were masked to treatment assignment .


Randomisation was done by a computerised randomisation sequence with permuted blocks of @ .


Participants received @ g ceftriaxone or placebo twice daily through a central venous catheter administered at home by a trained caregiver .


To minimise biliary side-effects , participants assigned to ceftriaxone also received @ mg ursodeoxycholic acid twice daily and those assigned to placebo received matched placebo capsules .


The coprimary efficacy outcomes were survival and functional decline , measured as the slope of Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised ( ALSFRS-R ) scores .


Analyses were by intention to treat .


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


Stage @ included @ participants from stages @ and @ and @ new participants .


In total , @ participants were randomly allocated to ceftriaxone and @ to placebo .


During stages @ and @ , mean ALSFRS-R declined more slowly in participants who received @ g ceftriaxone than in those on placebo ( difference @ units per month , @ % CI @ to @ ; p = @ ) , but in stage @ functional decline between the treatment groups did not differ ( @ , -@ to @ ; p = @ ) .


No significant differences in survival between the groups were recorded in stage @ ( HR @ , @ % CI @ to @ ; p = @ ) .


Gastrointestinal adverse events and hepatobiliary adverse events were more common in the ceftriaxone group than in the placebo group ( gastrointestinal , @ of @ -LSB- @ % -RSB- ceftriaxone vs @ of @ -LSB- @ % -RSB- placebo , p = @ ; hepatobiliary , @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- , p < @ ) .


Significantly more participants who received ceftriaxone had serious hepatobiliary serious adverse events ( @ participants -LSB- @ % -RSB- ) than did those who received placebo ( @ participants ) .


Despite promising stage @ data , stage @ of this trial of ceftriaxone in amyotrophic lateral sclerosis did not show clinical efficacy .


The adaptive design allowed for seamless transition from one phase to another , and central venous catheter use in the home setting was shown to be feasible .


This study describes a single-site investigation on the effects of a randomized double-blind placebo trial targeting duloxetine added to opioid use ( duloxetine + opioid ) against a comparator ( placebo + opioid ) in spine surgery patients , independent of major depression .


The double-blind comparator study assessed two groups on opioids : one using duloxetine and the other a placebo .


Subjects were administered the respective medication @ weeks prior to surgery and continued on this for more than @ months .


Subjects were assessed at three times : prior to surgery , @ weeks postsurgery , and @ weeks postsurgery .


They completed a battery of tests assessing for pain , adjustment , and psychiatric problems .


Neurosurgical outpatient and inpatient setting .


Sixty-eight patients completed the study .


They received one of three types of elective spine surgery .


Subjects were given duloxetine or placebo @ weeks prior to surgery and continued with the regimen for more than @ months .


The primary focus was pain and second on adjustment factors and psychiatric symptoms : depression and anxiety .


The amount of opioid use presurgery and postsurgery was also evaluated .


There were differences among the groups on Brief Pain Inventory ( BPI ) - Average , the core pain marker , and BPI-Sleep .


Within-subject analyses showed that duloxetine subjects improved significantly from baseline .


For function , post-CIBIC and post-Functional Adjustment Questionnaire were significant , favoring duloxetine .


Reduction of opioid use was not a factor ; both groups ' utilization declined .


For affect , both groups were significantly improved over time .


Duloxetine seems to improve pain , assist with maintaining function , and reduce intensity of affect .


Examine the effect of ABT-@ ( fenofibric acid ) on postprandial lipemia and susceptibility of plasma lipoproteins to Cu ( + + ) - mediated oxidation in patients with metabolic syndrome .


This is a randomized double-blind , placebo-controlled study with cross-over and includes a @-week wash-out period between the two treatment periods .


At the end of each @-week treatment period , subjects were challenged with a standardized mixed meal followed by blood collection over the ensuing @ h. Plasma lipoproteins were isolated by a combination of ultracentrifugation and FPLC for the continuous monitoring of conjugated dienes formation as an assessment of oxidative susceptibility .


Fasting plasma TG was reduced by @ % ( p < @ ) and there was a modest reduction in hsCRP ( @ % , p < @ ) .


There was no change in either HDLc or LDLc in these subjects .


Postprandial lipemia was reduced with ABT-@ as demonstrated by a @ % reduction ( p < @ ) in incremental area under the curve for TG during the @-h period after the meal challenge .


Lag times for both fasting LDL ( +@ % ) and postprandial LDL ( +@ % ) were increased with the ABT-@ therapy , suggestive of reduced oxidative susceptibility .


Co-incubation with autologous HDL did not reduced LDL oxidative susceptibility in these patients .


ABT-@ therapy reduced fasting and postprandial triglycerides in patients with metabolic syndrome .


Autologous HDL may be dysfunctional in these patients as co-incubation with HDL failed to reduce oxidative susceptibility of LDL .


During ABT-@ therapy , LDL was less susceptible to Cu ( + + ) - mediated oxidative modification , in spite of the lack of changes in LDLc levels .


To determine whether culture at a more physiologically cooler temperature , as suggested by limited human and animal data , would improve blastulation and pregnancy rates in human clinical IVF .


Paired randomized controlled trial .


Academic .


Infertile couples ( n = @ ) with a female partner less than @ years old with eight or more mature oocytes retrieved .


Mature oocytes obtained from a single cohort of oocytes were randomly divided into two groups ; one was cultured at @C and the other at @C from the time of ICSI to the time of embryo transfer or vitrification .


Paired embryo transfers were accomplished by transferring one euploid embryo from each group .


DNA fingerprinting was used as needed to determine the outcome for each embryo .


Rate of development of expanded blastocysts suitable for transfer or vitrification ( primary outcome ) , fertilization , aneuploidy , and sustained implantation .


A total of @ mature oocytes were cultured ; @ at @C and @ at @C .


Paired analysis demonstrated a higher rate of usable blastocyst formation per zygote at @C ( @ % ) vs. at @C ( @ % ) .


Rates of fertilization , aneuploidy , and sustained implantation were equivalent .


IVF culture at @C does not improve clinically relevant parameters of embryo development or sustained implantation rates .


To explore the protective effect and possible mechanism of intensive lipid modulation on the perioperative period of patients with stable coronary artery disease undergoing noncardiac surgery .


In the study , @ patients with stable coronary artery disease undergoing elective noncardiac surgery were randomly divided into intensive lipid modulation group ( n = @ ) and conventional group ( n = @ ) .


In intensive lipid modulation group , the patients were given atorvastatin @ mg every night before surgery , @ mg @ h before surgery , and @ mg @ h before surgery , and @ mg every night after noncardiac surgery .


In conventional group , the patients were given atorvastatin @ mg every night before surgery and also after the surgery .


The occurrence of perioperative major adverse cardiac events ( including sudden cardiac death , acute myocardial infarction , unplanned revascularization ) were compared in the two groups .


Preoperative and @ h postoperative changes of lipid levels and inflammatory markers were also compared in the two groups .


In conventional group , one patient suffered myocardial infarction with acute anterior ST-segment elevation and was given emergency left anterior descending artery interventional reperfusion therapy , and @ patients suffered asymptomatic myocardial infarction .


In intensive lipid modulation group , one patient suffered asymptomatic myocardial infarction , and the incidence rate of perioperative acute myocardial infarction reduced significantly compared with conventional group ( P < @ ) .


There was no significant difference in preoperative and postoperative changes of lipid levels in the two groups ( P > @ ) , and compared with conventional group , there was significantly lower levels of inflammatory markers in intensive lipid modulation group ( P < @ ) .


The intensive lipid modulation group significantly reduced the incidence of perioperative major adverse cardiac events especially asymptomatic myocardial infarction , and the inhibition of the inflammatory response may be one of the protective mechanisms , which still needs to be further confirmed by large multicenter randomized controlled clinical trials .


Calcium inhibits and ascorbic acid ( AA ) enhances iron absorption from iron-fortified foods .


Absorption efficiency depends on iron status , although the interaction is unclear .


We investigated the ability of AA to overcome calcium-induced inhibition of iron absorption in children differing in iron status .


The effect of calcium ( @ , @ , and @ mg/test meal ) on iron absorption in the absence and presence of AA ( @ , @ , and @ mg/test meal ) from a casein/whey-based drink fortified with ferrous sulfate was assessed in a series of randomized crossover studies both in iron-replete ( IR ) Indian schoolchildren and in children with iron deficiency anemia ( IDA ) ( @-@ y ; n = @-@ / group ) by using stable isotopes .


In the absence of calcium and AA , iron absorption from the casein/whey-based drink was @ % lower in IR children than in children with IDA .


The addition of calcium reduced mean iron absorption by @-@ % , with the effect being stronger for high added calcium ( P < @ ) .


AA at a @:@ or @:@ molar ratio enhanced iron absorption by a factor of @-@ and greatly overcompensated for the inhibitory effect of calcium on iron absorption in a dose-dependent manner ( P < @ ) .


The dose-response effect tended to be stronger ( P < @ ) in the IDA group , and iron status was of far less influence on iron absorption than the enhancing effect of AA .


When adding AA to iron-fortified milk products , care should be taken not to provide absorbable iron in excess of needs .


Migraine remains poorly treated , with few effective preventive drugs available .


We assessed the safety and efficacy of LY@ , a fully humanised monoclonal antibody to calcitonin gene-related peptide , for migraine prevention .


We did a randomised , double-blind , placebo-controlled , phase @ proof-of-concept study at @ centres in the USA .


Patients aged @-@ years with four to @ migraine headache days per month were randomly assigned ( @:@ ) to LY@ or placebo by a computerised randomisation scheme .


LY@ ( @ mg ) or placebo were given as a subcutaneous injection once every @ weeks for @ weeks .


The primary endpoint was the mean change in number of migraine headache days per @-day period assessed at @-@ weeks .


Safety was assessed over @ weeks , including the @-week treatment period and the subsequent @ weeks after study drug administration .


Patients and treating investigators were masked to treatment allocation .


Analyses were by intention to treat .


A mixed-effects model of repeated measures was used , including patient baseline value , treatment , visit , and treatment-by-visit interaction as fixed effects , and patients as random effects .


Safety measures were analysed according to the treatment received .


This study has been completed and is registered with ClinicalTrials.gov , NCT@ .


Between July @ , @ , and Sept @ , @ , @ patients were randomly assigned to LY@ ( n = @ , but one patient withdrew before treatment ) or placebo ( n = @ ) .


The mean change from baseline to week @ in the number of migraine headache days was -@ ( SD @ ; @ % decrease ) in the LY@ group compared with -@ ( SD @ ; @ % decrease ) in the placebo group ( least-squares mean difference -@ , @ % CI -@ to -@ ; p = @ ) .


Adverse events that occurred more frequently with LY@ than with placebo included injection site pain , erythema , or both ( @ -LSB- @ % -RSB- of @ vs seven -LSB- @ % -RSB- of @ ) , upper respiratory tract infections ( @ -LSB- @ % -RSB- vs ten -LSB- @ % -RSB- ) , and abdominal pain ( six -LSB- @ % -RSB- vs three -LSB- @ % -RSB- ) .


There were two serious adverse events reported in the treatment arm and four in the placebo arm , none of which were deemed to be related to the study drug .


These results provide preliminary evidence that LY@ might be beneficial in migraine prevention and provide support for the role of calcitonin gene-related peptide in the pathogenesis of migraine .


Further controlled studies are needed to assess the safety and efficacy of monoclonal calcitonin gene-related peptide antibodies for the preventive treatment of migraine .


Although the WHO recommends that complementary feeding in infants should begin at @ mo of age , it often begins before this in developed countries .


Our objective was to determine whether lactation consultant ( LC ) support , with educational resources given at @-mo postpartum , can delay the introduction of complementary foods until around @ mo of age .


A total of @ mother-infant pairs were recruited from the single maternity hospital serving Dunedin , New Zealand ( @ % response rate ) and randomly assigned to the following : @ ) usual care ( control group ) ; @ ) infant sleep education intervention ( Sleep ) ; @ ) food , activity , and breastfeeding intervention ( FAB ) ; or @ ) combination ( both ) intervention ( Combo ) .


Certified LCs delivered @ intervention sessions ( late pregnancy and @-wk and @-mo postpartum ) .


The @-mo contact used educational resources focused on developmental readiness for complementary foods .


Age when complementary foods were introduced was obtained from repeated interviews ( monthly from @ - to @-wk postpartum ) .


A total of @ % and @ % of infants received complementary foods before @ and @ mo of age , respectively .


There was evidence of group differences in the number of infants introduced to complementary foods before @ mo ( P = @ ) , with those receiving support and resources ( FAB and Combo groups combined ; @ % ) more likely to wait until at least @ mo compared with controls ( control and Sleep groups combined ; @ % ) ( OR : @ ; @ % CI : @ , @ ) .


However , there was no evidence they were more likely to wait until @ mo of age ( P = @ ) .


Higher maternal age , higher parity , and a less positive attitude toward breastfeeding were positively associated , and drinking alcohol during pregnancy was negatively associated , with later age of introduction of complementary foods .


Providing an LC and educational resources at @-mo postpartum to predominantly well-educated , mainly European , women can delay the introduction of complementary foods until @ mo of age , but not until the WHO recommendation of @ mo. .


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


Intradialytic hypertension affects @ % of hemodialysis patients and is associated with increased morbidity and mortality .


While intradialytic hypertension is associated with increases in endothelin @ relative to nitric oxide ( NO ) , the cause of these imbalances is unknown .


Invitro evidence suggests that altering plasma sodium levels could affect endothelial-derived vasoregulators and blood pressure ( BP ) .


Thus , we hypothesized that compared to high dialysate sodium , low dialysate sodium concentration would lower endothelin @ levels , increase NO release , and reduce BP .


@-week , @-arm , randomized , crossover study .


@ patients with intradialytic hypertension .


Low ( @ mEq/L below serum sodium ) versus high ( @ mEq/L above serum sodium ) dialysate sodium concentration .


Endothelin @ , nitrite ( NO@ ( - ) ) , and BP .


Mixed linear regression was used to compare the effect of dialysate sodium ( low vs high ) and randomization arm ( low-then-high vs high-then-low ) on intradialytic changes in endothelin @ , NO@ ( - ) , and BP values .


The average systolic BP throughout all hemodialysis treatments in a given week was lower with low dialysate sodium concentrations compared with treatments with high dialysate sodium concentrations ( parameter estimate,-@ @ -LSB- @ % CI,-@ @ to-@ @ -RSB- mm Hg ; P < @ ) .


The average change in systolic BP during hemodialysis also was significantly lower with low vs high dialysate sodium concentrations ( parameter estimate,-@ @ -LSB- @ % CI,-@ @ to-@ @ -RSB- mm Hg ; P < @ ) .


There were no significant differences in intradialytic levels of endothelin @ or NO@ ( - ) with low vs high dialysate sodium concentrations .


Carryover effects limited the power to detect significant changes in endothelial-derived vasoregulators , and future studies will require parallel trial designs .


Low dialysate sodium concentrations significantly decreased systolic BP and ameliorated intradialytic hypertension .


Longer studies are needed to determine the long-term effects of low dialysate sodium concentrations on BP and clinical outcomes .


To observe the efficacy of He-wei Jie-gu ( Chinese characters ) decoction on femoral intertrochanteric fractures after internal fixation in elderly .


From January @ to January @ , @ elderly patients with osteoporotic intertrochanteric fracture were randomly divided into two groups .


The patients in experimental group were treated with open reduction and internal fixation , He-wei Jie-gu decoction and Caltrate D in oral , including @ males and @ females with an average age of ( @ ) years old ranging from @ to @ years old ; the time from injured to operation was @ to @ days with an average of ( @ ) days ; according to Evans-Jensen classification , @ cases were in type I , @ in type II , @ in type III , @ in type IV , @ in type V. Meanwhile , the patients in control group were treated with open reduction and internal fixation , Caltrate D in oral , including @ males and @ females with an average age of ( @ ) years old ranging from @ to @ years old ; the time from injury to operation was @ to @ days with an average of ( @ ) days ; according to Evans-Jensen classification , @ cases were in type I , @ in type II , @ in type III , @ in type W , @ in type V.


The VAS score , hip BMD value before and after treatment , fracture healing and the Harris function score after operation were recorded and compared .


All patients were followed up from @ to @ months with an average of ( @ ) months .


Compared with the control group , the VAS score of the experimental group had an obviously reduction ( F = @ , P < @ ) after treatment ; the hip BMD value at @ months after treatment in the experimental group was higher than that of the control group ( P < @ ) ; the fracture healing rate of the experimental group was higher than that of the control group ( P < @ ) ; Harris score in @ months of follow-up in the experimental group was higher than that of the control group ( t = @ , P < @ ) ; all the differences between two groups were statistically significant ( P < @ ) .


He-wei Jie-gu decoction can reduce postoperative pain and increase bone mineral density after internal fixation of femoral intertrochanteric fracture in elderly , promote the fracture healing and functional recovery in the hip joint .


A novel musical memory aid has been proposed for aiding laypersons in complying with the American Heart Association ( AHA ) cardiopulmonary resuscitation ( CPR ) guidelines of @ compressions per minute ( cpm ) .


This study tested usefulness of such a memory aid to improve layperson long-term compliance with CPR compression rate guidelines .


A prospective randomized controlled trial was conducted using CPR-untrained laypersons .


Subjects received either a standard CPR educational experience ( AHA Heartsaver CPR class ) or an experimental CPR educational experience ( AHA Heartsaver CPR class augmented with a musical metronome ) .


Experimental group subjects were taught to perform compressions to the cadence of a pop music song ( The Bee Gees `` Stayin ' Alive '' ; Saturday Night Fever , The Original Movie Soundtrack ; Polygram International Music , @ ) with a tempo of @ beats/min .


Compression rates , depth of compressions , and correct compressions were measured initially and upon retesting @ weeks post-training .


Control subjects had a higher mean compression rate both immediately ( @ -LSB- standard deviation -LCB- SD -RCB- = @ -RSB- vs. @ -LSB- SD = @ -RSB- cpm ; @ % confidence interval -LSB- CI -RSB- of mean difference @-@ ; p = @ ) and at follow-up ( @ -LSB- SD = @ -RSB- vs. @ -LSB- SD = @ -RSB- cpm ; @ % CI of mean difference @-@ ; p = @ ) .


Compression rates stratified to @-@ cpm demonstrated no difference between groups initially ( @ % vs. @ % ; p = @ ) , but more experimental subjects maintained these rates at follow-up ( @ % vs. @ % ; p = @ ) .


Subjects trained to use a musical metronome more often maintained a compression rate of @-@ cpm at @-week follow-up , suggesting the memory aid may improve long-term guideline adherence .


Pain is frequent and distressing in people with dementia , but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome .


Three hundred fifty-two people with dementia and significant agitation from @ nursing home units were included in this study .


These units , representing @ nursing homes in western Norway , were randomized to a stepwise protocol of treating pain ( SPTP ) or usual care .


The SPTP group received acetaminophen , morphine , buprenorphine transdermal patch and pregabalin for @ weeks , with a @-week washout period .


Medications were governed by the SPTP and each participant 's existing prescriptions .


We obtained pain intensity scores from @ patients ( intervention n = @ , control n = @ ) at five time points assessed by the primary outcome measure , Mobilization-Observation-Behaviour-Intensity-Dementia-@ ( MOBID-@ ) Pain Scale .


The secondary outcome was activities of daily living ( ADL ) .


We used a linear intercept mixed model in a two-way repeated measures configuration to assess change over time and between groups .


The SPTP conferred significant benefit in MOBID-@ scores compared with the control group -LSB- average treatment effect ( ATE ) -@ ; p < @ -RSB- at week @ , and MOBID-@ scores worsened during the washout period ( ATE = -@ ; p = @ ) .


Examining different analgesic treatments , benefit was conferred to patients receiving acetaminophen compared with the controls at week @ ( ATE = -@ ; p = @ ) , continuing to increase until week @ ( ATE = -@ ; p < @ ) .


Although there were no overall improvements in ADL , an increase was seen in the group receiving acetaminophen ( ATE = +@ ; p = @ ) .


Pain medication significantly improved pain in the intervention group , with indications that acetaminophen also improved ADL function .


To explore the clinical efficacy and safety of compound digestive enzyme tablet in the treatment of dyspepsia .


A randomized , double-blind , double-dummy , positive drug parallel controlled , multicenter clinical trial was conducted for @ dyspeptic patients from October @ to August @ .


And they were randomized into group A ( experimental , n = @ ) and group B ( control , n = @ ) .


Group A received @ tablet of compound digestive enzyme tablet ( Bearse ) plus @ analog capsules of compound digestive enzyme thrice daily .


And group B had @ capsules of compound digestive enzyme capsule ( Dages ) plus @ analog tablet of compound digestive enzyme thrice daily .


The total duration of drug treatment was @ weeks .


There were @ follow-up visits ( W@ , W@ , W@ ) .


The primary endpoint was the total effective rate of all dyspeptic symptoms .


The total efficacy rate of groups A and B were @ % ( @/@ ) and @ % ( @/@ ) ( P > @ ) .


The adverse effects were @ % ( @/@ ) and @ % ( @/@ ) in groups A and B ( P > @ ) .


The adverse effects were mild in both groups .


Compound digestive enzyme tablet and capsule are effective and safe for patients with dyspepsia .


And compound digestive enzymes tablet is comparable to compound digestive enzyme capsule .


Onychomycosis is difficult to cure .


Systemic and topical treatments , including the @,@-nm Nd : YAG laser , are not very effective when used individually .


To compare the efficacy and safety of combined treatment with a long-pulsed @,@-nm Nd : YAG laser and oral terbinafine with those of either treatment alone .


We randomly divided @ patients with a total of @ infected nails into @ treatment groups : the T group received oral terbinafine , the L group received long-pulsed Nd : YAG laser treatment , and the T + L group received both treatments .


We evaluated the mycological clearance rate ( MCR ) and the clinical clearance rate ( CCR ) of the @ groups at Weeks @ , @ , @ , @ , and @ .


The MCR and CCR increased in all @ groups in a time-dependent manner .


The MCR and CCR of the T + L group were significantly higher than those of the T group and the L group at Weeks @ , @ , @ , and @ ( p < @ ) .


These data indicate that @ weeks of combined treatment with a long-pulsed Nd : YAG laser and oral terbinafine produce more rapid and effective mycological and clinical clearance in patients with onychomycosis than either treatment alone , without any obvious side effects .


This study investigated the effects of ethanol consumption on recovery from traditional resistance exercise in recreationally trained individuals .


Nine recreationally trained volunteers ( eight males and one female , @ @ yr , @ @ kg ) conducted four resistance exercise sessions and consumed a low ( @ ( females ) and @ ( males ) g kg ( -@ ) body mass ) or a high dose ( @ or @ g kg ( -@ ) body mass ) of ethanol @-@ @ h after exercise on two occasions .


The first session was for familiarization with the tests and exercises and was performed without ethanol consumption .


As a control trial , alcohol-free drinks were consumed after the exercise session .


The sequence of trials , with low and high ethanol doses and alcohol-free drinks ( control ) , was randomized .


Maximal voluntary contractions ( MVC ) ( knee extension ) , electrically stimulated contractions ( knee extension ) , squat jumps , and hand grip strength were assessed @-@ min and @ and @ h after the ethanol/placebo drinks .


In addition to a baseline sample , blood was collected @ , @ , and @ h after the ethanol/placebo drinks .


The exercise session comprised @ @ repetition maximum of squats , leg presses , and knee extensions .


MVC were reduced by @ % -@ % immediately after the exercise sessions ( P < @ ) .


MVC , electrically stimulated force , and squat jump performance were recovered @ h after ethanol drinks .


MVC was not fully recovered at @ h in the control trial .


Compared with those in the control , cortisol increased and the free testosterone/cortisol ratio were reduced after the high ethanol dose ( P < @ ) .


Neither a low nor a high dose of ethanol adversely affected recovery of muscle function after resistance exercise in recreationally strength-trained individuals .


However , the increased cortisol levels and reduced testosterone/cortisol ratio after the high ethanol dose could translate into long-term negative effects .


Early detection of melanoma improves survival .


Since many melanoma patients and their spouses seek the care of a physician after discovering their melanoma , an ongoing study will determine the efficacy of teaching at-risk melanoma patients and their skin check partner how to conduct skin self-examinations ( SSEs ) .


Internet-based health behavior interventions have proven efficacious in creating behavior change in patients to better prevent , detect , or cope with their health issues .


The efficacy of electronic interactive SSE educational intervention provided on a tablet device has not previously been determined .


The electronic interactive educational intervention was created to develop a scalable , effective intervention to enhance performance and accuracy of SSE among those at-risk to develop melanoma .


The intervention in the office was conducted using one of the following three methods : ( @ ) in-person through a facilitator , ( @ ) with a paper workbook , or ( @ ) with a tablet device used in the clinical office .


Differences related to method of delivery were elucidated by having the melanoma patient and their skin check partner provide a self-report of their confidence in performing SSE and take a knowledge-based test immediately after receiving the intervention .


The three interventions used @ of the @ behavioral change techniques defined by Abraham and Michie to promote planning of monthly SSE , encourage performing SSE , and reinforce self-efficacy by praising correct responses to knowledge-based decision making and offering helpful suggestions to improve performance .


In creating the electronic interactive SSE educational intervention , the educational content was taken directly from both the scripted in-person presentation delivered with Microsoft PowerPoint by a trained facilitator and the paper workbook training arms of the study .


Enrollment totaled @ pairs ( melanoma patient and their SSE partner ) with randomization of @ pairs to the in-person , @ pairs to the workbook , and @ pairs to electronic interactive SSE educational intervention .


The demographic survey data showed no significant mean differences between groups in age , education , or income .


The tablet usability survey given to the first @ tablet pairs found that , overall , participants found the electronic interactive intervention easy to use and that the video of the doctor-patient-partner dialogue accompanying the dermatologist 's examination was particularly helpful in understanding what they were asked to do for the study .


The interactive group proved to be just as good as the workbook group in self-confidence of scoring moles , and just as good as both the workbook and the in-person intervention groups in self-confidence of monitoring their moles .


While the in-person intervention performed significantly better on a skill-based quiz , the electronic interactive group performed significantly better than the workbook group .


The electronic interactive and in-person interventions were more efficient ( @ minutes ) , while the workbook took longer ( @ minutes ) .


This study suggests that an electronic interactive intervention can deliver skills training comparable to other training methods , and the experience can be accommodated during the customary outpatient office visit with the physician .


Further testing of the electronic interactive intervention 's role in the anxiety of the pair and pair-discovered melanomas upon self-screening will elucidate the impact of these tools on outcomes in at-risk patient populations .


Experts advise against parenteral nutrition ( PN ) for patients with advanced cancer at the end of life .


But because many patients and families fear starvation , many physicians administer PN to patients with terminal cancer in Korea .


We designed this study to investigate the effect of PN on survival in patients with terminal cancer at the end of life .


We planned a randomized phase II study enrolling @ patients randomized to receive either fluid or PN .


Eligible patients are who could not tolerate enteral feeding and had short life expectancies ( < @ months ) due to progressive cancer .


Patients with functioning bowels were excluded .


The primary end point was overall survival and the secondary end point was total administered calories .


We prospectively enrolled @ consecutive patients and @ patients were assigned to the PN group .


The study ended early because many patients and families were extremely concerned about starvation .


The baseline characteristics , including nutritional parameters , were not significantly different between the two groups .


The mean administered calories was @ ( @ ) kcal/d for the fluid group and @ ( @ ) kcal/d for the PN group ( p < @ ) .


Median survival was @ days ( @ % confidence interval -LSB- CI -RSB- , @-@ @ days ) in the fluid group and @ days ( @ % CI : @-@ @ days ) in the PN group , and this difference was not statistically significant ( p = @ by Log-rank test ) .


This study did not conclusively determine the role of PN for patients with advanced cancer , however , PN support failed to significantly prolong survival in these patients compared to similar patients receiving only fluid .


Breast ptosis may be caused by several factors , including significant weight loss , pregnancy , long breastfeeding periods , and involution of the postmenopausal breast tissue .


The authors performed a prospective study to evaluate patient satisfaction and the rate of complications after modified round block mastopexy versus traditional round block mastopexy .


Forty-four patients fulfilled the inclusion criteria for undergoing round block mastopexy in a prospective randomized controlled study performed from @ to @ .


All the patients received polyurethane silicone implants .


Group A included patients who underwent the traditional round block technique described by Benelli .


Group B included patients who underwent the traditional round block and @ cardinal glando-glandular permanent sutures .


The overall satisfaction with body appearance after breast mastopexy was rated on a scale of @ ( poor ) , @ ( fair ) , @ ( good ) , @ ( very good ) , and @ ( excellent ) .


Group A patient ages ranged from @ to @ years and in Group B ranged from @ to @ years .


The mean implant volume was @ cc in both Groups .


The complication and satisfaction rates for both Groups are reported .


The combination of the cardinal glandulo-glandular sutures along with the traditional round block appears to be key to preventing the areolar enlargement and persistent breast ptosis .


The satisfaction rates in patients who underwent the modified round mastopexy appear superior when compared to the traditional round block mastopexy .


Furhter long-term follow-up need to be performed in order to confirm the favorable results seen in this series of cases .


Urinary tract infections ( UTI ) are the most frequent bacterial infection affecting women and account for about @ % of antibiotics prescribed in primary care .


However , some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics , while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics .


Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance , and wastes resources .


@ adult female patients will be recruited from four primary care research networks ( Wales , England , Spain , the Netherlands ) and individually randomised to either POCT guided care or the guideline-informed ` standard care ' arm .


Urine and stool samples ( where possible ) will be obtained at presentation ( day @ ) and two weeks later for microbiological analysis .


All participants will be followed up on the course of their illness and their quality of life , using a @ week self-completed symptom diary .


At @ months , a primary care notes review will be conducted for evidence of further evidence of treatment failures , recurrence , complications , hospitalisations and health service costs .


Although the Flexicult POCT is used in some countries in routine primary care , it 's clinical and cost effectiveness has never been evaluated in a randomised clinical trial .


If shown to be effective , the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe .


During clinical development of the licensed Japanese encephalitis chimeric virus vaccine ( JE-CV ) , the neutralization capacity of vaccine-induced antibodies was assessed against the vaccine virus and against well characterized wild-type ( wt ) viruses isolated between @-@ .


We assessed whether JE-CV-induced antibodies can also neutralize more recent wt Japanese encephalitis virus ( JEV ) isolates including a genotype @ isolate .


Sera from @-@month-old children who received a single dose of JE-CV in a phase III study in Thailand and the Philippines ( ClinicalTrials.gov NCT@ ) were randomly selected and pooled according to neutralization titer against JE-CV into eight samples .


Neutralization was assessed by plaque reduction neutralization tests ( PRNT@ ) against three recent isolates from JEV genotypes @ and @ in addition to four JEV previously tested .


Neutralization titers against the three recent JEV strains were comparable to those observed previously against other strains and the vaccine virus .


The observed differences between responses to genotype @ and @ viruses were within assay variability for the PRNT@ .


The results were consistent with previously generated data on the neutralization of wt JEV isolates , immune responses induced by JE-CV neutralize recently isolated virus from southeast ( SE ) Asia and India .


Evidence regarding what comprises effective education for acne vulgaris patients is lacking .


Internet-based education may improve patient knowledge of this condition .


Our objective was to compare the effectiveness of standard web-based education and an automated counseling website in improving acne knowledge .


In a randomized trial , participants visited either a standard website or an automated counseling website to learn about acne .


Multiple-choice questions were administered at baseline and after @weeks to assess change in acne knowledge .


A total of @ high school students were enrolled , and @ completed the study .


The standard website group had a significant increase in knowledge from baseline ( @ ) to @-week follow-up ( @ , p < @ ) .


Similarly , the automated counseling website group had a significant increase in knowledge between both time points ( @ vs. @ , p < @ ) .


After @ weeks , mean improvement in knowledge was higher in the automated counseling group ( @ ) than in the standard website group ( @ , d = @ , p = @ ) .


The number of website visits was positively correlated with improvement in knowledge in both groups .


Finally , the automated counseling website group rated their educational material more useful ( p = @ ) and more enjoyable to view ( p = @ ) than did the standard website group .


This study is limited to adolescents with mild-to-moderate acne vulgaris .


Internet-based patient education appears to be an effective method of improving acne knowledge among adolescents .


Neuropeptide Y is a key peptide affecting adiposity and has been related to obesity risk .


However , little is known about the role of NPY variations in diet-induced change in adiposity .


The objective was to examine the effects of NPY variant rs@ on central obesity and abdominal fat distribution in response to dietary interventions .


We genotyped a functional NPY variant rs@ among @ participants in the Preventing Overweight Using Novel Dietary Strategies trial .


Changes in waist circumference ( WC ) , total abdominal adipose tissue , visceral adipose tissue , and subcutaneous adipose tissue ( SAT ) from baseline to @ and @ mo were evaluated with respect to the rs@ genotypes .


Genotype-dietary fat interaction was also examined .


The rs@ C allele was associated with a greater reduction in WC at @ mo ( P < @ ) .


In addition , the genotypes showed a statistically significant interaction with dietary fat in relation to WC and SAT ( P-interaction = @ and @ ) : the association was stronger in individuals with high-fat intake than in those with low-fat intake .


At @ mo , the association remained statistically significant for WC in the high-fat diet group ( P = @ ) , although the gene-dietary fat interaction became nonsignificant ( P = @ ) .


In addition , we found statistically significant genotype-dietary fat interaction on the change in total abdominal adipose tissue , visceral adipose tissue , and SAT at @ mo ( P = @ , @ , and @ ) : the rs@ T allele appeared to associate with more adverse change in the abdominal fat deposition in the high-fat diet group than in the low-fat diet group .


Our data indicate that the NPY rs@ genotypes affect the change in abdominal adiposity in response to dietary interventions , and the effects of the rs@ single-nucleotide polymorphism on central obesity and abdominal fat distribution were modified by dietary fat .


To compare clinical and subjective quality-of-life ( QoL ) data for teenagers wearing daily disposable contact lenses or spectacles .


This open-label study randomized subjects ( aged @ to @ years ) with no previous contact lens wear experience to nelfilcon A ( DAILIES AquaComfort Plus ) contact lenses or spectacles for @ months .


A full clinical workup , as well as subjective QoL measures using the Pediatric Refractive Error Profile and Quality of Life Impact of Refractive Correction questionnaires , was conducted at baseline and at week @ and months @ and @ , with an additional study visit at week @ for subjects randomized to wear contact lenses .


A total of @ teenagers were enrolled in the study ; @ discontinued before study completion , @ ( @ % ) from the contact lens group and @ ( @ % ) from the spectacle group ( p = @ ) .


Visual acuity was good for both groups at all study visits .


Biomicroscopy assessments were similar at baseline for both groups .


Significant differences in Pediatric Refractive Error Profile responses were noted between vision correction groups across visits for appearance ( p < @ ) , satisfaction ( p < @ ) , activities ( p < @ ) , peer perception ( p = @ ) , and overall score ( p < @ ) .


For Quality of Life Impact of Refractive Correction , the contact lens group gave more favorable responses than the spectacle group ( p = @ ) .


After @ months of wearing contact lenses , teenagers had a more positive attitude toward comfort , vision , and safety with contact lenses .


No serious adverse events were reported during the study .


The daily disposable lenses used in this study are suitable for vision correction for teenagers , offering improvements in QoL measures during the first month of wear , including appearance , satisfaction , activities , and peer perceptions , without negatively impacting vision or eye health .


Teenagers were able to handle contact lenses with the same amount of confidence as spectacles .


Severe deficiencies of testosterone ( T ) and GH are associated with low bone mineral density ( BMD ) and increased fracture risk .


Replacement of T in hypogonadal men improves several bone parameters .


Replacement of GH in GH-deficient men improves BMD .


Our objective was to determine whether T and GH treatment together improves the structural and mechanical parameters of bone more than T alone in men with hypopituitarism .


This randomized , prospective , @-year study included @ men with severe deficiencies of T and GH due to panhypopituitarism .


Subjects were randomized to receive T alone ( n = @ ) or T and GH ( n = @ ) for @ years .


We evaluated magnetic resonance microimaging-derived structural ( bone volume fraction -LSB- BVF -RSB- and trabecular thickness ) and mechanical ( axial stiffness -LSB- AS -RSB- , a measure of bone strength ) properties of the distal tibia at baseline and after @ and @ years of treatment .


Treatment with T and GH did not affect BVF , thickness , or AS differently from T alone .


T treatment in all subjects for @ years increased trabecular BVF by @ % ( P < @ ) , trabecular thickness by @ % ( P < @ ) , and trabecular AS by @ % ( P < @ ) .


In contrast , testosterone treatment in all subjects significantly increased cortical thickness by @ % ( P < @ ) but decreased cortical BVF by -@ % ( P < @ ) and cortical AS by -@ % ( P < @ ) .


Combined T and GH treatment of men with hypopituitarism for @ years did not improve the measured structural or mechanical parameters of the distal tibia more than T alone .


However , testosterone significantly increased the structural and mechanical properties of trabecular bone but decreased most of these properties of cortical bone , illustrating the potential importance of assessing trabecular and cortical bone separately in future studies of the effect of testosterone on bone .


Traumatic brain injury ( TBI ) is the leading cause of death and disability in the US .


Approximately @-@ % of the TBI cases are classified as mild , and up to @ % of them will not recover and suffer chronic neurocognitive impairments .


The main pathology in these cases involves diffuse brain injuries , which are hard to detect by anatomical imaging yet noticeable in metabolic imaging .


The current study tested the effectiveness of Hyperbaric Oxygen Therapy ( HBOT ) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments .


The trial population included @ mTBI patients @-@ years after injury with prolonged post-concussion syndrome ( PCS ) .


The HBOT effect was evaluated by means of prospective , randomized , crossover controlled trial : the patients were randomly assigned to treated or crossover groups .


Patients in the treated group were evaluated at baseline and following @ HBOT sessions ; patients in the crossover group were evaluated three times : at baseline , following a @-month control period of no treatment , and following subsequent @-months of @ HBOT sessions .


The HBOT protocol included @ treatment sessions ( @ days/week ) , @ minutes each , with @ % oxygen at @ ATA .


`` Mindstreams '' was used for cognitive evaluations , quality of life ( QOL ) was evaluated by the EQ-@D , and changes in brain activity were assessed by SPECT imaging .


Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period .


SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements .


HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage .


The Grip on Challenging Behavior care program was developed using the current guidelines and models on managing challenging behavior in dementia in nursing homes .


It was hypothesized that the use of the care program would lead to a decrease in challenging behavior and in the prescription of psychoactive drugs without increase in use of restraints .


A randomized controlled trial was undertaken using a stepped-wedge design to implement the care program and to evaluate the effects .


An assessment of challenging behavior and psychoactive medication was undertaken every @ months on all participating units followed by the introduction of the care program in a group of @ to @ units .


A total of @ time assessments took place over @ months .


Seventeen dementia special care units of different nursing homes .


A total of @ residents of dementia special care units .


All residents with dementia on the unit were included .


Units were assigned by random allocation software to @ of @ groups with different starting points for the implementation of the care program .


A care program consisting of various assessment procedures and tools , which ensure a multidisciplinary approach and which structure the process of managing challenging behavior in dementia .


Challenging behavior was measured using the Cohen-Mansfield Agitation Inventory ( CMAI ) and the Neuropsychiatric Inventory .


Research assistants ( blinded for intervention status of the unit ) interviewed nurses on the units about challenging behavior .


Data on psychoactive drugs and restraints were retrieved from resident charts .


A total of @ assessments took place involving @ residents ( @ control measurements , @ intervention measurements ) .


The group of residents who remained in the intervention condition compared with the group in the control condition differed significantly in the CMAI change scores between successive assessments -LSB- -@ CMAI points , @ % confidence interval ( CI ) -@ to -@ -RSB- .


No significant effects were found for the control-to-intervention group compared with the group who remained in the control group ( @ CMAI points , @ % CI -@ to @ ) .


Significant effects were found on @ of the @ Neuropsychiatric Inventory items and on the use of antipsychotics ( odds ratio @ , @ % CI @ - @ ) and antidepressants ( odds ratio @ , @ % CI @-@ @ ) .


No effect on use of restraints was observed .


The Grip on Challenging behavior program was able to diminish some forms of challenging behavior and the use of psychoactive drugs .


HIV-infected prisoners have a high prevalence of alcohol use disorders and commonly relapse to alcohol soon after release to the community which is linked to high morbidity , poor antiretroviral therapy ( ART ) adherence and increased sexual risk-taking behaviors .


Extended-release naltrexone ( XR-NTX ) effectively reduces relapse to alcohol in alcohol dependent persons , yet it remains unexamined among criminal justice system ( CJS ) populations transitioning to the community .


A randomized double-blind , placebo-controlled trial of XR-NTX to improve HIV treatment outcomes via reducing relapse to alcohol use after prison release for HIV-infected hazardous drinking and alcohol dependent prisoners is discussed .


Acceptability of study participation is high with @ % of those referred who met eligibility criteria and @ % of those who were able to receive injections prior to release accepted injections , yet important implementation issues are identified and addressed during the study and are discussed in this paper .


Medication-assisted therapies for prevention of relapse to alcohol use for CJS populations transitioning to the community , especially for HIV-infected patients , are urgently needed in order to reduce alcohol relapse after release and improve HIV treatment outcomes and contribute to improved individual and public health .


To examine whether the consumption of a Mediterranean diet ( MedDiet ) , compared with a low-fat diet , interacts with two single nucleotide polymorphisms at the tumor necrosis factor alpha gene ( rs@ , rs@ ) in order to improve triglycerides ( TG ) , glycemic control , and inflammation markers .


Genotyping , biochemical measurements , dietary intervention , and oral fat load test meal were determined in @ metabolic syndrome ( MetS ) patients selected from all the subjects included in CORDIOPREV clinical trial ( n = @ ) .


At baseline , G/G subjects ( n = @ ) at the rs@ polymorphism , showed higher fasting and postprandial TG ( p = @ and p = @ , respectively ) , and high sensitivity C-reactive protein ( hsCRP ) ( p = @ ) plasma concentrations than carriers of the minor A-allele ( G/A + A/A ) ( n = @ ) .


After @ months of MedDiet , baseline differences between genotypes disappeared .


The decrease in TG and hsCRP was statistically significant in G/G subjects ( n = @ ) compared with carriers of the minor A-allele ( p = @ and p = @ , respectively ) ( n = @ ) .


No other gene-diet interactions were observed in either diet .


These results suggest that the rs@ at the tumor necrosis factor alpha gene interacts with MedDiet to influence TG metabolism and inflammation status in MetS subjects .


Understanding the role of gene-diet interactions may be the best strategy for personalized treatment of MetS .


We investigated real-life oral anticoagulation ( OAC ) treatment after surgical ablation and examined its adherence to current recommendations .


We also explored factors related to OAC use preoperatively and at follow-up .


One hundred and fifteen patients with atrial fibrillation ( AF ) were evaluated during @-month follow-up after surgery .


Patients were divided into two categories according to the congestive heart failure , hypertension , age @ years , diabetes and prior stroke -LSB- or transient ischaemic attack or thromboembolism -RSB- ( CHADS@ ) score : @ patients were assigned to the high-risk group ( CHADS@ score @ ) and @ to the low-risk group ( CHADS@ score @ ) .


OAC use was defined as guideline adherent , undertreatment or overtreatment .


Baseline overall guideline adherence was @ % .


OAC was underprescribed in high-risk patients and overprescribed in low-risk patients ( both , P < @ ) .


The only factor associated with OAC use after logistic regression analysis were age > @ years ( P = @ ) and preoperative AF > paroxysmal ( P = @ ) .


Overall guideline adherence at @-month follow-up showed a trend towards a better adherence in the sinus rhythm ( SR ) subgroup ( @ % vs @ % , P = @ ) .


OAC was underprescribed in high-risk patients and overprescribed in low-risk patients ( both P < @ ) .


After logistic regression analysis , preoperative OAC use ( P = @ ) and other indications for OAC ( P = @ ) were predictors of anticoagulation treatment .


Real-life OAC prescription in AF patients showed a moderate guideline adherence , with high-risk patients being undertreated and low-risk patients being overtreated .


These findings stress the importance that antithrombotic treatment in patients undergoing AF surgery needs to be critically re-evaluated .


Memory T-cells are mediators of transplant injury , and no therapy is known to prevent the development of cross-reactive memory alloimmunity .


Activated vitamin D is immunomodulatory , and vitamin D deficiency , common in hemodialysis patients awaiting transplantation , is associated with a heightened alloimmune response .


Thus , we tested the hypothesis that vitamin D@ supplementation would prevent alloreactive T-cell memory formation in vitamin D-deficient hemodialysis patients .


We performed a @-month single-center pilot randomized , controlled trial of @,@ IU/week of cholecalciferol ( D@ ) versus no supplementation in @ hemodialysis patients with serum @ ( OH ) D < @ ng/mL , measuring effects on serum @ ( OH ) D and phenotypic and functional properties of T-cells .


Participants were randomized @:@ to active treatment versus control .


D@ supplementation increased serum @ ( OH ) D at @ weeks ( @ -LSB- @ -RSB- ng/mL to @ -LSB- @ -RSB- ng/mL , p < @ ) and for the duration of the study .


No episodes of sustained hypercalcemia occurred in either group .


Results of IFN ELISPOT-based panel of reactive T-cell assays ( PRT ) , quantifying alloreactive memory , demonstrated greater increases in the controls over @ year compared to the treatment group ( delta PRT in treatment @ + / -@ vs @ + / -@ in control ) , but these changes in PRT between groups did not reach statistical significance ( p = @ ) .


D@ supplements are safe , effective at treating vitamin D deficiency , and may prevent time-dependent increases in T-cell alloimmunity in hemodialysis patients , but their effects on alloimmunity need to be confirmed in larger studies .


These findings support the routine supplementation of vitamin D-deficient transplant candidates on hemodialysis and highlight the need for large-scale prospective studies of vitamin D supplementation in transplant candidates and recipients .


To investigate the timing and value of noninvasive ventilation ( NIV ) as a weaning tool immediately after early extubation in patients with acute respiratory distress syndrome ( ARDS ) .


A prospective randomized controlled trial was conducted .


The ARDS patients with surgical diseases admitted to Department of Respiratory Intensive Care Unit ( RICU ) of the First Affiliated Hospital of Xinjiang Medical University were enrolled .


The patients were randomly divided into sequential group and control group .


All patients underwent endotracheal intubation and were mechanically ventilated .


Every @ hours during the first @ days , the lung recruitment maneuver was performed during pressure control ventilation ( PCV ) .


After lung recruitment , all patients were ventilated with synchronized intermittent mandatory ventilation ( SIMV ) + pressure support ventilation ( PSV ) + positive end-expiratory pressure ( PEEP ) or assistant/control ventilation ( A/C ) .


The objects in sequential group who met the following criteria including those with oxygen index ( PaO@/FiO@ ) reaching @-@ mmHg ( @ mmHg = @ kPa ) under PEEP of @ cmH@O ( @ cmH@O = @ kPa ) , and pressure support of @ cmH@O , and most acute infiltrating lesions having resolved on chest imaging , received noninvasive ventilation ( NIV ) immediately after extubation , and patients in control group continued to have invasive mechanical ventilation via intubation or tracheostomy with an endotracheal tube .


The baseline data in both groups and the number of re-intubation in the sequential group were recorded .


The duration of invasive mechanical ventilation and total duration of mechanical ventilation , ICU length of stay , the incidence of ventilator-associated pneumonia ( VAP ) , and mortality rate were compared between the two groups .


@ consecutive adult patients were enrolled , including @ in sequential group and @ cases in control group .


The period of endotracheal intubation was @ ( @ , @ ) days , and @ % ( @/@ ) patients underwent re-intubation in sequential group .


There were significant difference in respiratory and circulatory indicators before extubation spontaneous breathing trial ( SBT ) @ minutes in sequential group , indicating that the patients were still in the early stage of extubation sequential NIV .


There was no significant difference in indices reflecting respiratory function and circulation between the two groups , except that respiratory rate at @ hour was slightly increased in sequential group as compared with that of control group , indicating that sequential NIV could maintain invasive ventilation function .


There was significant difference in duration of invasive mechanical ventilation -LSB- @ ( @ , @ ) days vs. @ ( @ , @ ) days , Z = -@ , P = @ -RSB- , duration of total mechanical ventilation ( @ days vs. @ days , t = -@ , P = @ ) , and length of ICU stay ( @ days vs. @ days , t = -@ , P = @ ) between sequential group and control group , but there was no significant differences in the incidence of VAP -LSB- @ % ( @/@ ) vs. @ ( @/@ ) , ( @ ) = @ , P = @ -RSB- and mortality rate -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P = @ -RSB- .


When PaO@/FiO@ reached @-@ mmHg under the condition of low ventilation , sequential NIV facilitates the early discontinuation of mechanical ventilation in ARDS patients with surgical diseases , with shortening of duration of invasive mechanical ventilation , total mechanical ventilation , and the length of ICU stay .


Low serum @-hydroxyvitamin D levels ( @ ( OH ) D ) have been associated with a higher likelihood of seasonal affective disorder ( SAD ) and poor mental well-being , yet firm evidence for either remains lacking .


Thus , vitamin D supplementation may alleviate symptoms associated with SAD .


This study was a randomized , single-centre , double-blind , placebo-controlled trial including healthcare professionals employed in psychiatric and somatic hospitals .


@ healthcare professionals were invited to participate , @ participants were screened , and @ were able to complete the study .


The main inclusion criterion was @ points or more on question no. @ of the Seasonal Pattern Assessment Questionnaire ( SPAQ-SAD ) .


During a @-month period , the participants received a daily dose of @g vitamin D or placebo .


The primary outcome was the sum of the self-reported questionnaire Structured Interview Guide for the Hamilton Depression Rating Scale , Seasonal Affective Disorders ( SIGH-SAD ) .


The secondary outcome was World Health Organization-Five Well-Being Index ( WHO-@ ) of the healthcare professionals during the winter period and the exploratory outcome measures were weight , waist circumference , blood pressure , absenteeism from work and @ ( OH ) D.


There were no significant between-group differences in SIGH-SAD sums at @weeks ( p = @ ( CI : - @ to @ ) ) .


However , there was a significant improvement of primary SIGH-SAD over time from inclusion ( autumn-winter ) to the completion of the study ( winter-spring ) for all participants .


The secondary and exploratory outcome measures were all insignificant between groups.The sums of the SIGH-SAD at @weeks were not significantly different -LSB- p = @ ( CI : @-@ @ ) -RSB- between the groups .


There was , however , a significant improvement in primary SIGH-SAD sums over time from inclusion ( autumn-winter ) to the completion of the study ( winter-spring ) in both groups .


The secondary and explorative outcome measures were not significantly different between groups .


There were no significant between-group differences in the primary ( SIGH-SAD ) and secondary ( WH@-@ ) as well as the exploratory outcome measures ( weight , waist circumference , blood pressure , absenteeism from work and @ ( OH ) D. Thus , the study failed to demonstrate an effect of vitamin D on SAD symptoms , but our findings may be limited by confounders .


Furthermore , the study was underpowered and did not allow us to assess the ability of vitamin D to improve mood in those with low @ ( OH ) D.


Secondary hyperparathyroidism is a common consequence of chronic kidney disease .


Cinacalcet ( Sensipar ( ) ) is often prescribed in combination to reduce elevated levels of parathyroid hormone , calcium and phosphorus .


The objective of this study was to assess the effects of concomitantly administered therapies of calcium carbonate ( CaCO ( @ ) ; TUMS ( ) ) , sevelamer hydrochloride ( HCl ; Renagel ( ) ) and pantoprazole sodium ( Protonix ( ) ) on the pharmacokinetics and safety of cinacalcet in healthy subjects .


Three randomized , open-label , two-way crossover pharmacokinetic studies were conducted in healthy subjects .


Participants received single doses of cinacalcet alone or in combination with either CaCO ( @ ) , sevelamer HCl or pantoprazole .


The pharmacokinetic profile of cinacalcet was characterized .


Safety assessments including adverse event reporting , changes in vital signs and clinical laboratory measurements were conducted throughout the studies .


The @ % confidence intervals for the area under the concentration-time curve from time zero to the last quantifiable concentration ( AUC ( last ) ) , area under the concentration-time curve from time zero to infinity ( AUC ( @ - ) ) and maximum plasma concentration ( C ( max ) ) of cinacalcet were within the accepted range of @-@ % for both CaCO ( @ ) and sevelamer HCl co-administration with cinacalcet .


No severe or serious adverse events or clinically relevant changes in physical or laboratory findings occurred during the studies .


The pharmacokinetic parameters of cinacalcet were not affected by co-administration of CaCO ( @ ) , sevelamer HCl or pantoprazole .


Co-administration of these agents with cinacalcet does not require an adjustment of the dose of cinacalcet .


We examined the efficacy of a community-based , culturally relevant intervention to promote healthy eating and physical activity among African American ( AA ) women between the ages of @-@ years , residing in rural Alabama .


We conducted a group randomized controlled trial with counties as the unit of randomization that evaluated two interventions based on health priorities identified by the community : ( @ ) promotion of healthy eating and physical activity ; and ( @ ) promotion of breast and cervical cancer screening .


A total of @ counties with @ participants were enrolled in the study between November @ and October @ .


The overall retention rate at @-month follow-up was @ % .


Higher retention rate was observed in the `` healthy lifestyle '' arm ( @ % ) as compared to the `` screening '' arm ( @ % ) .


Participants in the `` healthy lifestyle '' arm showed significant positive changes compared to the `` screening '' arm at @-month follow-up with regard to decrease in fried food consumption and an increase in both fruit/vegetable intake and physical activity .


At @-month follow-up , these positive changes were maintained with healthy eating behaviors , but not engagement in physical activity .


A culturally relevant intervention , developed in collaboration with the target audience , can improve ( and maintain ) healthy eating among AA women living in rural areas .


To compare local infiltration of dexamethasone to intravenous injection for postoperative pain and recovery after tonsillectomy .


Prospective , randomized study .


Second Affiliated Hospital of Harbin Medical University .


Children ( n = @ , American Society of Anesthesiologists -LSB- ASA -RSB- classes I-II , aged @-@ y ) scheduled for tonsillectomy were randomly and equally assigned to @ groups : DEX-IV , for intravenous injection of dexamethasone ( @ mg/kg , maximum dose @ mg ) ; DEX-INF , given the same amount of dexamethasone by local infiltration to the upper middle and lower poles of the tonsils ; and a control group not given dexamethasone .


Postoperative pain was scored at intervals from @ minutes to @ hours .


The time to first administration of analgesic and average consumption of analgesic , times to first oral water and solid food intake , and incidence rates of nausea and vomiting were evaluated .


From postoperative @ to @ hours , the DEX-INF group had significantly lower pain scores than did the DEX-IV group , and the time to first analgesic and average consumption of analgesic were also significantly lower .


The times to first oral water and food intake in the DEX-INF group were significantly shorter than in the DEX-IV group .


The incidence of nausea and vomiting in the DEX-INF group was higher than that of the DEX-IV group .


Local infiltration of dexamethasone was more effective than systemic administration to decrease pain and time to food intake , but the antiemetic effect was less .


A vicious circle of decreased physical fitness , early fatigue , and low physical activity levels ( PAL ) is thought to affect children with cerebral palsy ( CP ) .


However , the relationship of changes in physical fitness to changes in PAL and fatigue is unclear .


The objective of this study was to investigate the associations among changes in physical fitness , walking-related PAL , and fatigue in children with CP .


This study was a secondary analysis of a randomized controlled trial with measurements at baseline , @ months ( after the intervention period ) , and @ months .


Twenty-four children with bilateral spastic CP and @ with unilateral spastic CP , aged @ to @ years , all walking , participated in this study .


Physical fitness was measured by aerobic capacity , anaerobic threshold , anaerobic capacity , and isometric and functional muscle strength .


Walking-related PAL was measured using an ankle-worn activity monitor for @ week .


Fatigue was determined with the Pediatric Quality of Life ( PedsQL ) Multidimensional Fatigue Scale .


Longitudinal associations were analyzed by random coefficient regression analysis .


In children with bilateral CP , all fitness parameters showed a positive , significant association with walking-related PAL , whereas no associations between physical fitness and walking-related PAL were seen in children with unilateral CP .


No clinically relevant association between physical fitness and fatigue was found .


Although random coefficient regression analysis can be used to investigate longitudinal associations between parameters , a causal relationship can not be determined .


The actual direction of the association between physical fitness and walking-related PAL , therefore , remains inconclusive .


Children with bilateral spastic CP might benefit from improved physical fitness to increase their PAL or vice versa , although this is not the case in children with unilateral CP .


There appears to be no relationship between physical fitness and self-reported fatigue in children with CP .


Interventions aimed at improving PAL may be differently targeted in children with either bilateral or unilateral CP .


Effective interventions to reduce HIV incidence in sub-Saharan Africa are urgently needed .


Mathematical modelling and the HIV Prevention Trials Network ( HPTN ) @ trial results suggest that universal HIV testing combined with immediate antiretroviral treatment ( ART ) should substantially reduce incidence and may eliminate HIV as a public health problem .


We describe the rationale and design of a trial to evaluate this hypothesis .