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MS2_dynamic_1_shot_test

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MS2_dynamic_1_shot0

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: An anthroposophic lifestyle , which has been associated with reduced allergy risk in children , has several characteristics that could influence gut microbiota . This study aim ed to investigate the impact of anthroposophic lifestyle as well as specific early life exposures on the gut microbiota . In total , 665 stool sample s from 128 mother-infant pairs from the ALADDIN birth cohort study were included . Sample s collected from infants at ages 6 days , 3 weeks , 2 months and 6 months , and from their mothers before and after delivery , respectively , were analyzed using 454-pyrosequencing . Information regarding lifestyle exposures was collected prospect ively through interviews and question naires . Six-month-old infants in anthroposophic families had a significantly higher abundance of Bifidobacterium and lower abundances of Bacteroides and Veillonella . Caesarean section and breastfeeding had a significant impact on the microbiota : caesarean section was primarily associated with delayed colonization of Bifidobacterium and Bacteroides , whereas breastfed children had a higher relative abundance of Bifidobacterium and a lower abundance of Clostridiales . However , despite large differences in lifestyle exposures , we determined no significant differences in the gut microbiota between the anthroposophic and non-anthroposophic mothers or their infants ' before 6 months of age Background Neonatal sepsis due to intestinal bacterial translocation is a major cause of morbidity and mortality . Underst and ing microbial colonisation of the gut in prematurity may predict risk of sepsis to guide future strategies to manipulate the microbiome . Methods Prospect i ve longitudinal study of premature infants . Stool sample s were obtained weekly . DNA was extracted and the V6 hypervariable region of 16S rRNA was amplified followed by high throughput pyrosequencing , comparing subjects with and without sepsis . Results Six neonates were 24–27 weeks gestation at birth and had 18 sample s analysed . Two subjects had no sepsis during the study period , two developed late-onset culture-positive sepsis and two had culture-negative systemic inflammation . 324 350 sequences were obtained . The meconium was not sterile and had predominance of Lactobacillus , Staphylococcus and Enterobacteriales . Overall , infants who developed sepsis began life with low microbial diversity , and acquired a predominance of Staphylococcus , while healthy infants had more diversity and predominance of Clostridium , Klebsiella and Veillonella . Conclusions In very low birth weight infants , the authors found that meconium is not sterile and is less diverse from birth in infants who will develop late-onset sepsis . Empiric , prolonged antibiotics profoundly decrease microbial diversity and promote a microbiota that is associated not only with neonatal sepsis , but the predominant pathogen previously identified in the microbiome . Our data suggest that there may be a ‘ healthy microbiome ’ present in extremely premature neonates that may ameliorate risk of sepsis . More research is needed to determine whether altered antibiotics , probiotics or other novel therapies can re-establish a healthy microbiome in neonates Perinatal administration of the probiotic Lactobacillus rhamnosus strain GG ( ATCC 53103 ) , reduces incidence of atopic eczema in at-risk children during the first 2 years of life ( infancy ) . We have therefore assessed persistence of the potential to prevent atopic eczema at 4 years . Atopic disease was diagnosed on the basis of a question naire and a clinical examination . 14 of 53 children receiving lactobacillus had developed atopic eczema , compared with 25 of 54 receiving placebo ( relative risk 0.57 , 95 % CI 0.33 - 0.97 ) . Skin prick test reactivity was the same in both groups : ten of 50 children previously given lactobacillus compared with nine of 50 given placebo tested positive . Our results suggest that the preventive effect of lactobacillus GG on atopic eczema extends beyond infancy Abstract Objective : To test the hypothesis that maternal complications significantly affect gut colonization patterns in very low birth weight infants . Methods : Forty-nine serial stool sample s were obtained weekly from nine extremely premature infants enrolled in a prospect i ve longitudinal study . Sequencing of the bacterial 16S rRNA gene from stool sample s was performed to approximate the intestinal microbiome . Linear mixed effects models were used to evaluate relationships between perinatal complications and intestinal microbiome development . Results : Subjects with prenatal exposure to a non-sterile intrauterine environment , i.e. prolonged preterm premature rupture of membranes ( PPPROM ) and chorioamnionitis exposure , were found to have a relatively higher abundance of potentially pathogenic bacteria in the stool across all time points compared to subjects without those exposures , irrespective of exposure to postnatal antibiotics . Compared with those delivered by Caesarean section , vaginally delivered subjects were found to have significantly lower diversity of stool microbiota across all time points , with lower abundance of many genera , most in the family Enterobacteriaceae . Conclusions : We identified persistently increased potential pathogen abundance in the developing stool microbiota of subjects exposed to a non-sterile uterine environment . Maternal complications appear to significantly influence the diversity and bacterial composition of the stool microbiota of premature infants , with findings persisting over time Background The ' hygiene hypothesis ' suggests that early exposure to microbes can be protective against atopic disease . The intestinal microbial flora could operate as an important postnatal regulator of the Th1/Th2 balance . The aim of the study was to investigate the association between early intestinal colonisation and the development of asthma in the first 3 years of life . Methods In a prospect OUTPUT: Overall , a greater relative abundance of Bacteroidaceae , Clostridiaceae , and Enterobacteriaceae and a lower relative abundance of Bifidobacteriaceae and Lactobacillaceae is associated with the development of allergic sensitization , eczema , or asthma . Reduced bacterial diversity can be associated with the development of allergic disease . The association between the composition of the intestinal microbiota and the development of allergic disease or asthma is less consistent in older children than in neonates , suggesting that early‐life microbial exposure plays a more important role . INPUT: ABSTRACT A healthy intestinal microbiota is considered to be important for priming of the infants ' mucosal and systemic immunity . Breast-fed infants typically have an intestinal microbiota dominated by different Bifidobacterium species . It has been described that allergic infants have different levels of specific Bifidobacterium species than healthy infants . For the accurate quantification of Bifidobacterium adolescentis , Bifidobacterium angulatum , Bifidobacterium bifidum , Bifidobacterium breve , Bifidobacterium catenulatum , Bifidobacterium dentium , Bifidobacterium infantis , and Bifidobacterium longum in fecal sample s , duplex 5′ nuclease assays were developed . The assays , targeting rRNA gene intergenic spacer regions , were vali date d and compared with conventional PCR and fluorescent in situ hybridization methods . The 5′ nuclease assays were subsequently used to determine the relative amounts of different Bifidobacterium species in fecal sample s from infants receiving a st and ard formula or a st and ard formula supplemented with galacto- and fructo-oligosaccharides ( OSF ) . A breast-fed group was studied in parallel as a reference . The results showed a significant increase in the total amount of fecal bifidobacteria ( 54.8 % ± 9.8 % to 73.4 % ± 4.0 % ) in infants receiving the prebiotic formula ( OSF ) , with a diversity of Bifidobacterium species similar to breast-fed infants . The intestinal microbiota of infants who received a st and ard formula seems to resemble a more adult-like distribution of bifidobacteria and contains relatively more B. catenulatum and B. adolescentis ( 2.71 % ± 1.92 % and 8.11 % ± 4.12 % , respectively , versus 0.15 % ± 0.11 % and 1.38 % ± 0.98 % for the OSF group ) . In conclusion , the specific prebiotic infant formula used induces a fecal microbiota that closely resembles the microbiota of breast-fed infants also at the level of the different Bifidobacterium species Preterm infants have an impaired gut barrier function . We aim ed to determine the effects of enteral supplementation of a prebiotic mixture consisting of neutral oligosaccharides ( short-chain galacto-oligosaccharides (SCGOS)/long-chain fructo-oligosaccharides ( LCFOS ) ) and acidic oligosaccharides ( AOS ) on intestinal permeability of preterm infants as measured by the sugar absorption test in the first week of life . Furthermore , we determined host- and treatment-related factors associated with intestinal permeability . In a r and omised controlled trial , preterm infants with a gestational age < 32 weeks and /or birth weight ( BW ) < 1500 g received enteral supplementation of SCGOS/LCFOS/AOS or placebo ( maltodextrin ) between days 3 and 30 of life . Intestinal permeability , reflected by the urinary lactulose/mannitol ( L/M ) ratio after oral ingestion of lactulose and mannitol , was assessed at three time points : before the start of the study ( t = 0 ) , at day 4 ( t = 1 ) and at day 7 ( t = 2 ) of life . Data were analysed by generalised estimating equations . In total , 113 infants were included . Baseline patient and nutritional characteristics were not different between the SCGOS/LCFOS/AOS ( n 55 ) and the placebo groups ( n 58 ) . SCGOS/LCFOS/AOS had no effect on the L/M ratio between t = 0 and t = 2 . In both the groups , the L/M ratio decreased from t = 0 to t = 2 ( P < 0·001 ) . Low BW increased the L/M ratio ( P = 0·002 ) . Exclusive breast milk feeding and mixed breast milk/formula feeding during the first week of life decreased the L/M ratio ( P < 0·001 and P < 0·05 , respectively ) . In conclusion , enteral supplementation of a prebiotic mixture does not enhance the postnatal decrease in intestinal permeability in preterm infants in the first week of life BACKGROUND Galactooligosaccharides ( GOS ) and long-chain fructooligosaccharides ( lcFOS ) proliferate bifidobacteria in infant gut microbiota . However , it is not known how GOS and FOS influence the microbiota of pregnant women and whether a potential prebiotic effect is transferred to the offspring . OBJECTIVES We aim ed to test how supplementation with GOS and lcFOS ( GOS/lcFOS ) in the last trimester of pregnancy affects maternal and neonatal gut microbiota . Variables of fetal immunity were assessed as a secondary outcome . DESIGN In a r and omized , double-blind , placebo-controlled pilot study , 48 pregnant women were supplemented 3 times/d with 3 g GOS/lcFOS ( at a ratio of 9:1 ) or maltodextrin ( placebo ) from week 25 of gestation until delivery . Percentages of bifidobacteria and lactobacilli within total bacterial counts were detected by fluorescent in situ hybridization and quantitative polymerase chain reaction in maternal and neonatal ( days 5 , 20 , and approximately 182 ) stool sample s. Variables of fetal immunity were assessed in cord blood by using flow cytometry and cytokine multiplex-array analysis . RESULTS The proportions of bifidobacteria in the maternal gut were significantly higher in the supplemented group than in the placebo group ( 21. OUTPUT:

Current evidence from systematic review and meta- analysis revealed that probiotics are the most promising intervention in reduction of the incidence of NEC in VLBW neonates . As per the evidence , prebiotics modulate the composition of human intestine microflora to the benefit of the host by suppression of colonization of harmful microorganism and /or the stimulation of bifidobacterial growth , decreased stool viscosity , reduced gastrointestinal transit time , and better feed tolerance .

MS2_dynamic_1_shot1

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND No studies have examined whether increased consumption of oat cereal , rich in soluble fiber , favorably alters lipoprotein particle size and number . OBJECTIVE We examined the effects of large servings of either oat or wheat cereal on plasma lipids , lipoprotein subclasses , lipoprotein particle diameters , and LDL particle number . DESIGN Thirty-six overweight men aged 50 - 75 y were r and omly assigned to consume daily for 12 wk either oat or wheat cereal providing 14 g dietary fiber/d . Before and after the intervention , plasma lipid and lipoprotein subclasses were measured with proton nuclear magnetic resonance spectroscopy , and whole-body insulin sensitivity was estimated with the frequently sample d intravenous-glucose-tolerance test . RESULTS Time-by-treatment interactions ( P < 0.05 ) for LDL cholesterol ( oat : -2.5 % ; wheat : 8.0 % ) , small LDL cholesterol ( oat : -17.3 % ; wheat : 60.4 % ) , LDL particle number ( oat : -5.0 % ; wheat : 14.2 % ) , and LDL : HDL cholesterol ( oat : -6.3 % ; wheat : 14.2 % ) were observed . Time-by-treatment interactions were nearly significant for total cholesterol ( oat : -2.5 % ; wheat : 6.3 % ; P = 0.08 ) , triacylglycerol ( oat : -6.6 % ; wheat : 22.0 % ; P = 0.07 ) , and VLDL triacylglycerol ( oat : -7.6 % ; wheat : 2.7 % ; P = 0.08 ) . No significant time-by-treatment interactions were observed for HDL cholesterol , HDL-cholesterol subclasses , or LDL , HDL , and VLDL particle diameters . Insulin sensitivity did not change significantly with either intervention . CONCLUSIONS The oat compared with the wheat cereal produced lower concentrations of small , dense LDL cholesterol and LDL particle number without producing adverse changes in blood triacylglycerol or HDL-cholesterol concentrations . These beneficial alterations may contribute to the cardioprotective effect of oat fiber BACKGROUND The US Food and Drug Administration ( FDA ) approved health cl aims for 2 dietary fibers , beta-glucan ( 0.75 g/serving ) and psyllium ( 1.78 g/serving ) , on the assumption that 4 servings/d would reduce cardiovascular disease risk . OBJECTIVE We assessed the efficacy of this dose of fibers in reducing serum lipid risk factors for cardiovascular disease . DESIGN Sixty-eight hyperlipidemic adults consumed a test ( high-fiber ) and a control low-fat ( 25 % of energy ) , low-cholesterol ( < 150 mg/d ) diet for 1 mo each in a r and omized crossover study . The high-fiber diet included 4 servings/d of foods containing beta-glucan or psyllium that delivered 8 g/d more soluble fiber than did similar , unsupplemented foods in the control diet . Fasting blood sample s and blood pressure readings were obtained at baseline and weeks 2 and 4 , and the subjects ' weight was monitored weekly . RESULTS Compared with the control diet , the high-fiber diet reduced total cholesterol ( 2.1 + /- 0.7 % ; P = 0.003 ) , total : HDL cholesterol ( 2.9 + /- 0.8 % ; P = 0.001 ) , LDL : HDL cholesterol ( 2.4 + /- 1.0 % ; P = 0.015 ) , and apolipoprotein B : A-I ( 1.4 + /- 0.8 % ; P = 0.076 ) . Applying the Framingham cardiovascular disease risk equation to the data confirmed a reduction in risk of 4.2 + /- 1.4 % ( P = 0.003 ) . Small reductions in blood pressure were found after both diets . The subjects reported no significant differences in palatability or gastrointestinal symptoms between the diets . CONCLUSIONS The reduction in serum lipid risk factors for cardiovascular disease supports the FDA 's approval of a health cl aim for a dietary fiber intake of 4 servings/d . Although relatively small in terms of patient treatment , the reduction in cardiovascular disease risk is likely to be significant on a population basis BACKGROUND Dietary fiber intake remains low despite increasing evidence for its health benefits , including laxation . OBJECTIVE We aim ed to assess the effects of increasing fiber intake on bowel habits and gastrointestinal tolerance in healthy persons consuming a typical Canadian or US diet . DESIGN Under a r and omized crossover design , 23 free-living participants consumed a typical Canadian or US diet ( 35 % fat , 12 g fiber/d ) and received 25.0 - 28.7 g fiber/d from each of 5 breakfast cereals : All-Bran ( AB ) , Bran Buds with Corn ( BBC ) , Bran Buds with Psyllium ( BBP ) , BBC with viscous fiber blend ( VFB ) , or a low-fiber control for 3 wk , with each study arm separated by a washout of > /=1 wk . Seven-day stool collection s and a symptom diary were obtained during the last week of each study arm . RESULTS All study cereals induced significant ( P < 0.05 ) increases in fecal bulk from the control diet at 128 + /- 38 g to 199 + /- 5 OUTPUT: There was a wide variety of fibre sources used , with little similarity between groups in the choice of intervention . Adverse events , where reported , appeared to mostly reflect mild to moderate gastrointestinal side-effects and these were generally reported more in the fibre intervention groups than the control groups . The pooled analyses for CVD risk factors suggest reductions in total cholesterol and LDL cholesterol with increased fibre intake , and reductions in diastolic blood pressure . INPUT: The effects of the soluble fiber konjac glucomannan ( GM ) on serum cholesterol concentrations were investigated in 63 healthy men in a double-blind crossover , placebo-controlled study . After a 2-wk baseline period , the subjects were given 3.9 g GM or placebo daily for 4 wk . After a washout period of 2 wk , crossover took place , followed by another 4 wk of treatment . The subjects were encouraged not to change their ordinary diets or general lifestyle during the investigation . GM fibers reduced total cholesterol ( TC ) concentrations by 10 % ( P < 0.0001 ) , low-density-lipoprotein cholesterol ( LDL-C ) concentrations by 7.2 % ( P < 0.007 ) , triglycerides by 23 % ( P < 0.03 ) , and systolic blood pressure by 2.5 % ( P < 0.02 ) . High-density-lipoprotein cholesterol ( HDL-C ) and the ratio of LDL-C to HDL-C did not change significantly . No change in diastolic blood pressure or body weight was observed . No adverse effects were observed . The results of this study show that GM is an effective cholesterol-lowering dietary adjunct BACKGROUND Fiber supplements added to a caloric diet have additional effects on weight reduction in overweight subjects . The aim of this study was to compare the effect of various commercial fiber supplements ( glucomannan , guar gum and alginate ) on weight reduction in healthy overweight subjects . MATERIAL / METHODS One hundred and seventy six men and women were included to receive either active fiber substance or placebo in r and omized placebo-controlled studies . The fiber supplements consisted of the viscous fibers glucomannan ( Chrombalance ) , glucomannan and guar gum ( Appe-Trim ) and glucomannan , guar gum and alginat ( Glucosahl ) . RESULTS All fiber supplements plus a balanced 1200 kcal diet induced significantly weight reduction more than placebo and diet alone , during a five week observation period . However , there were no significant differences between the different fibers in their ability to induce weight reduction , which was approximately 0.8 kg/week ( 3.8 + /- 0.9 , 4.4 + /- 2.0 , 4.1 + /- 0.6 in the Chrombalance , Appe-Trim and Glucosahl group , respectively ) . CONCLUSIONS Glucomannan induced body weight reduction in healthy overweight subjects , whereas the addition of guar gum and alginate did not seem to cause additional loss of weight Dietary fibres are frequently used for the treatment of paediatric obesity . The aim of this clinical trial is to evaluate the efficacy of glucomannan in the child obesity management . This experimental design was double blinded with a block r and omisation , alpha = 0.05 , beta = 0.2 and delta = 50 % . The study involved 60 children under 15 years of age ( mean age 11.2 years , mean overweight 46 % ) , 30 of them under glucomannan treatment ( 1 g twice a day for two months ) and 30 under placebo and the same schedule . The drug and the placebo were indistinguishable both for the family and the physician . During the two months study period the children followed a normocaloric diet evaluated every two weeks by a dietetic record book . At the beginning of the study the drug and the placebo groups were comparable in regards to anthropometric data . At the end , the mean overweight of the drug group was decreased from 49.5 % to 41 % and that of the placebo group from 43.9 % to 41.7 % . Both decreases were significant ( p < 0.01 ) , but no significant difference was observed between the drug and the placebo groups . The only significant difference concerned the lipid metabolism . The children under glucomannan treatment manifested a significant decrease of alpha-lipoprotein and an increase of pre-beta-lipoprotein and triglycerides ; the children under placebo manifested only a decrease of triglycerides and apo beta-lipoprotein . We suggest that this metabolic alteration may derive from a primary decrease of alpha-lipoprotein , most likely because of an inadequate water intake . ( ABSTRACT TRUNCATED AT 250 WORDS Carbohydrate-restricted diets ( CRDs ) promote weight loss , reductions in plasma triacylglycerol ( TAG ) levels , and increases in high-density lipoprotein cholesterol ( HDL-C ) levels but may cause undesirable low-density lipoprotein cholesterol ( LDL-C ) responses in some people . The objective of the present study was to determine the effect of adding soluble fiber to a CRD on plasma LDL-C and other traditionally measured markers of cardiovascular disease . Using a parallel-arm , double-blind , placebo-controlled design , 30 overweight and obese men ( body mass index , 25 - 35 kg/m(2 ) ) were r and omly assigned to supplement a CRD with soluble fiber ( Konjac-mannan , 3g/d ) ( n = 15 ) or placebo ( n = 15 ) . Plasma lipids , anthropometrics , body composition , blood pressure , and nutrient intake were evaluated at baseline and at 6 and 12 weeks . Compliance was excellent as assessed by 7-day weighed dietary records and ketonuria . Both groups experienced decreases in ( P < .01 ) body weight , percent body fat , systolic blood pressure , waist circumference , and plasma glucose levels . After 12 weeks , HDL-C and TAG improved significantly in the fiber ( 10 % and -34 % ) and placebo ( 14 % , -43 OUTPUT:

The use of glucomannan did not appear to significantly alter any other study endpoints . Pediatric patients , patients receiving dietary modification , and patients with impaired glucose metabolism did not benefit from glucomannan to the same degree . Glucomannan appears to beneficially affect total cholesterol , LDL cholesterol , triglycerides , body weight , and FBG , but not HDL cholesterol or BP

MS2_dynamic_1_shot2

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The current study was design ed to explore the use of behavioral ( i.e. , accuracy and reaction times ) and electrophysiological measures ( i.e. , event-related potentials ) to assess the impact of a family-based preventive intervention for preschool-aged , maltreated children in foster care . These measures were recorded during a computerized flanker task design ed to assess cognitive control and response monitoring . The sample was recruited from a larger r and omized efficacy trial of Multidimensional Treatment Foster Care for Preschoolers ( MTFC-P ) and included foster children assigned to the intervention condition ( n = 10 ) , foster children assigned to a services-as-usual comparison condition ( n = 13 ) , and low-income , nonmaltreated community children ( n = 11 ) . The children ’s behavioral and electrophysiological performance on the task was generally consistent with previous research with adults and older children . There were no group differences on the behavioral measures of cognitive control or response monitoring . Notably , however , group differences were observed on the electrophysiological measures of response monitoring . Specifically , the foster children who received services as usual were significantly less responsive to performance feedback about errors than the foster children who received the intervention and the nonmaltreated children . Applications of this methodology and implication s of the results for future prevention research are discussed Children with language processing deficits have various learning impairments and poor scholastic performance . In 3 - 10 % of all children a specific language processing deficit can be identified by the Sound Connecting Sub-Test of the Illinois Test of Psycholinguistic-Abilities ( SC-ITPA ) . These children among which we drew our index group ( AS-Group ) suffer from the disability to recognize isolated sounds as parts of words . Following linguistic terminology this is known as an auditory sequential sound processing deficit ( ASSPD ) Eighteen children ( AS-Group ) and 21 controls ( C-Group ) were subjected to mapped P300 evoked potential analyses of cortical response to acoustic stimulation in the oddball paradigm . The data presented here show that there exists significant relation between the P300 amplitude reduction and ASSPD . The P300 amplitude decrease measured in the AS-Group is due to a reduced information transmission in accordance with Johnson 's Triarchic Model of the P300 Amplitude . The cerebral structures involved in poor language processing are localized at the left temporo-parietal cortex . This supports the hypothesis that the underlying neuronal defect of ASSPD is localized in the language center and not in the auditory pathway . The P300 amplitude may serve as electrophysiological tool to identify ASSPD and to quantify the degree of improvement in the course of specific therapy The magnocellular deficit theory is one of the prominent hypotheses in dyslexia research . However , recent studies have produced conflicting results . Ten dyslexic children and 12 controls were examined with visual evoked potentials elicited by r and om dot kinematogram . The experiment comprises two sequences , one with r and omly moving dots ( control condition ) and a second sequence where a fraction of the dots were moved coherently at the left or right side ( depending on the level of coherence , 10 % , 20 % , and 40 % of the dots ) . R and omly moving dots elicited two components , a P100 and P200 , which were not different between the groups . Coherently moving dots elicited a late positivity between 300 and 800 ms , which was significantly attenuated in dyslexic children . The area of this component becomes larger at a higher level of coherence . This study supports the hypothesis of an impairment of a specific magnocellular function in dyslexia PURPOSE To verify the effectiveness of the Cognitive Auditory Evoked Potential-P300 ( CAEP-P300 ) for monitoring the therapeutical evolution of students with developmental dyslexia . METHODS Twenty students diagnosed with developmental dyslexia , of both genders , aged between 8 and 14 years , divided into two r and omized groups , one of them su bmi tted to a phonological remediation program associated with reading and writing ( GI ) , and the other one representing the control group ( GII ) , participated in the study . The groups were paired up , and the individuals were su bmi tted to two evaluations of the CAEP-P300 and the same interval was kept for both . Paired Student 's t-test , ANOVA test , and Pearson 's correlation coefficient were used , adopting 5 % significance level . RESULTS The statistical comparison of the pre and post evaluations of each group demonstrated difference in the Phonological Awareness Test ( p=0.000 ) and in the P300 latency ( p=0.005 ) only for GI . CONCLUSION CAEP-P300 use for monitoring the therapeutical evolution of children with developmental dyslexia is possible and represents a viable option for intervention programs PURPOSE To evaluate whether a hypothesis suggesting that apraxia of speech results from phonological overspecification could be relevant for childhood apraxia of speech ( CAS ) . METHOD High-density EEG was recorded from 5 children with CAS and 5 matched controls , ages 5 - 8 years , with and without CAS , as they listened to r and omized sequences of CV syllables in two oddball paradigms : phonemic ( /ba/ , /pa/ ) and allophonic ( /pa/ , /p(h)a/ ) . RESULTS In the phonemic contrast condition , mismatch negativity ( MMN ) responses to oddball sounds were observed for the typically developing ( comparison ) group but not the CAS group , although a component similar to an immature mismatch response was apparent . The allophonic contrast did not elicit MMN responses in the comparison group , but in the CAS group , an MMN-like response was observed . CONCLUSION The authors propose that these preliminary findings are consistent with a view of CAS as a disorder that not only affects motor planning but also has a phonological component OUTPUT: The present meta- analysis demonstrates that speech therapy does not influence the latency and amplitude results of the P300 evoked potential in children undergoing speech therapy intervention INPUT: The aims of this study were 1 ) to evaluate whether subjects suffering from acute mountain sickness ( AMS ) during exposure to high altitude have signs of autonomic dysfunction and 2 ) to verify whether autonomic variables at low altitude may identify subjects who are prone to develop AMS . Forty-one mountaineers were studied at 4,559-m altitude . AMS was diagnosed using the Lake Louise score , and autonomic cardiovascular function was explored using spectral analysis of R-R interval and blood pressure ( BP ) variability on 10-min resting recordings . Seventeen subjects ( 41 % ) had AMS . Subjects with AMS were older than those without AMS ( P < 0.01 ) . At high altitude , the low-frequency ( LF ) component of systolic BP variability ( LF(SBP ) ) was higher ( P = 0.02 ) and the LF component of R-R variability in normalized units ( LF(RR)NU ) was lower ( P = 0.001 ) in subjects with AMS . After 3 mo , 21 subjects ( 43 % with AMS ) repeated the evaluation at low altitude at rest and in response to a hypoxic gas mixture . LF(RR)NU was similar in the two groups at baseline and during hypoxia at low altitude but increased only in subjects without AMS at high altitude ( P < 0.001 ) and did not change between low and high altitude in subjects with AMS . Conversely , LF(SBP ) increased significantly during short-term hypoxia only in subjects with AMS , who also had higher resting BP ( P < 0.05 ) than those without AMS . Autonomic cardiovascular dysfunction accompanies AMS . Marked LF(SBP ) response to short-term hypoxia identifies AMS-prone subjects , supporting the potential role of an exaggerated individual chemoreflex vasoconstrictive response to hypoxia in the genesis of AMS OBJECTIVE : Although a history of previous acute mountain sickness ( AMS ) is commonly used for providing advice and recommending its prophylaxis during subsequent exposure , the intraindividual reproducibility of AMS during repeated high-altitude exposure has never been examined in a prospect i ve controlled study . METHODS : In 27 nonacclimatized children and 29 adults , AMS was assessed during the first 48 hours after rapid ascent to 3450 m on 2 consecutive occasions 9 to 12 months apart . RESULTS : During the first exposure , 18 adults ( 62 % ) and 6 children ( 22 % ) suffered from AMS ; during the second exposure , 14 adults ( 48 % ) and 4 children ( 15 % ) suffered from this problem ( adults versus children , P ≤ .01 ) . Most importantly , the intraindividual reproducibility of AMS was very different ( P < .001 ) between children and adults . None of the 6 children having suffered from AMS during the first exposure suffered from AMS during the second exposure , but 4 children with no AMS during the first exposure did experience this problem during the second exposure . In contrast , 14 of the 18 adults who suffered from AMS on the first occasion also presented with this problem during the second exposure , and no new case developed in those who had not experienced AMS on the first occasion . CONCLUSIONS : In adults , a history of AMS is highly predictable of the disease on subsequent exposure , whereas in children it has no predictive value . A history of AMS should not prompt practitioners to advise against reexposure to high altitude or to prescribe drugs for its prophylaxis in children Study Objective : Despite causing significant morbidity throughout the mountainous regions of the world , the pathophysiology of acute mountain sickness ( AMS ) remains poorly understood . This study aims to improve the underst and ing of altitude illness by determining if vascular endothelial growth factor ( VEGF ) plays a role in the development of AMS . The purpose of this study was to determine if elevated plasma VEGF correlates with increased symptoms of AMS at high altitude . Patients and Methods : This is a prospect i ve study of a cohort of healthy climbers on Denali ( Mount McKinley ) in Alaska at 14 , 200 feet . Baseline demographics , medications , rates of ascent , and AMS scores were recorded . Pulse oximetry measurements and venous blood sample s were obtained . Comparisons were made between mountaineers with and without AMS . Results : Seventy-two climbers were approached for participation in the study ; 21 ( 29 % ) refused . Of the 51 climbers participating in the study , 14 subjects ( 27.5 % ) had symptoms of AMS and 37 subjects ( 72.5 % ) were free of symptoms of AMS . Plasma VEGF levels were 79.14 pg/dl ( SD : 121.44 ) and 57.57pg/dl ( SD : 102.71 ) in the AMS and non-AMS groups , respectively . These results were nonsignificant . Similarly , comparison of sex , age , rate of ascent , pulse oximetry values , or history of altitude illness did not reveal significant differences between the AMS and non-AMS groups . Conclusion : This study does not provide evidence in support of the theory that plasma VEGF correlates with symptoms of AMS Forty-seven climbers participated in a double-blind , r and omized trial comparing acetazolamide 250 mg , dexamethasone 4 mg , and placebo every eight hours as prophylaxis for acute mountain sickness during rapid , active ascent of Mount Rainier ( elevation 4,392 m ) . Forty-two subjects ( 89.4 percent ) achieved the summit in an average of 34.5 hours after leaving sea level . At the summit or high point attained above base camp , the group taking dexamethasone reported less headache , tiredness , dizziness , OUTPUT:

Ensuring that the characteristics of the history and future ascents are similar may improve the clinical utility of AMS history

MS2_dynamic_1_shot3

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND There are no controlled , prospect i ve studies comparing the 10-year outcomes of anterior cruciate ligament ( ACL ) reconstruction using patellar tendon ( PT ) and 4-str and hamstring tendon ( HT ) autografts . HYPOTHESIS Comparable results are possible with HT and PT autografts . STUDY DESIGN Cohort study ; Level of evidence , 2 . METHODS One hundred eighty ACL-deficient knees that met inclusion criteria underwent ACL reconstruction ( 90 HT autograft , 90 PT autograft ) by one surgeon and were treated with an accelerated rehabilitation program . All knees were observed in a prospect i ve fashion with subjective , objective , and radiographic evaluation at 2 , 5 , 7 , and 10-year intervals . RESULTS At 10 years , there were no differences in graft rupture rates ( 7/90 PT vs. 12/90 HT , P = .24 ) . There were 20 contralateral ACL ruptures in the PT group , compared with 9 in the HT group ( P = .02 ) . In all patients , graft rupture was associated with instrumented laxity > 2 mm at 2 years ( P = .001 ) . Normal or near-normal function of the knee was reported in 97 % of patients in both groups . In the PT group , harvest-site symptoms ( P = .001 ) and kneeling pain ( P = .01 ) were more common than in the HT group . More patients reported pain with strenuous activities in PT knees than in HT knees ( P = .05 ) . Radiographic osteoarthritis was more common in PT knees than the HT-reconstructed knees ( P = .04 ) . The difference , however , was composed of patients with mild osteoarthritis . Other predictors of radiographic osteoarthritis were < 90 % single-legged hop test at 1 year and the need for further knee surgery . An " ideal " outcome , defined as an overall International Knee Documentation Committee grade of A or B and a radiographic grade of A at 10 years after ACL reconstruction , was associated with <3 mm of instrumented laxity at 2 years , the absence of additional surgery in the knee , and HT grafts . CONCLUSIONS It is possible to obtain excellent results with both HT and PT autografts . We recommend HT reconstructions to our patients because of decreased harvest-site symptoms and radiographic osteoarthritis Purpose Primary aim of the study was analysis of hamstring tendon regeneration after anterior cruciate ligament reconstruction ( ACLR ) . Secondary aim was analysis of isokinetic muscle strength in relation to hamstring regeneration . The hypothesis was that regeneration of hamstring tendons after ACLR occurs and that regenerated hamstring tendons contribute to isokinetic hamstring strength with regeneration distal to the knee joint line . Methods Twenty-two patients scheduled for ACLR underwent prospect i ve MRI analysis of both legs . MRI parameters were tendon regeneration and morphology , muscle retraction and muscle cross-sectional area . A double-blind , prospect i ve analysis of isokinetic quadriceps and hamstrings strength was performed . Results Regeneration of the gracilis tendon after ACLR occurred in all patients . Regeneration of the semitendinosus tendon occurred in 14 patients . At 1 year , the surface area of the semitendinosus and gracilis muscle decreased compared to both preoperatively ( P < 0.01 ) and the contralateral leg ( P < 0.01 ) . The cross-sectional area of the semitendinosus muscle decreased in the absence of tendon regeneration ( P = 0.05 ) . The cross-sectional area of the gracilis muscle was greater in case of regeneration distal to the joint line ( P = 0.01 ) . Muscle retraction of the semitendinosus muscle was increased in case of nonregeneration ( P = 0.02 ) . There was no significant relationship between isokinetic flexion strength and tendon regeneration . Conclusion Hamstring tendons regenerated after harvest of both semitendinosus and gracilis tendons for ACLR . There was no relation between isokinetic flexion strength and tendon regeneration . Level of evidence Prognostic study , Level II Abstract Coactivation of knee flexors during knee extension assists in joint stability by exerting an opposing torque to the anterior tibial displacement induced by the quadriceps . This opposing torque is believed to be generated by eccentric muscle actions that stiffen the knee , thereby attenuating strain to joint ligaments , particularly the anterior cruciate ligament ( ACL ) . However , as the lengths of knee muscles vary with changes in joint position , the magnitude of flexor/extensor muscle force coupling may likewise vary , possibly affecting the capacity for active knee stabilization . The purpose of this study was to assess the effect of changes in movement speed and joint position on eccentric/concentric muscle action relationships in the knees of uninjured ( UNI ) and post-ACL-surgery ( INJ ) subjects ( n = 14 ) . All subjects were tested for maximum eccentric and concentric torque of the contralateral knee flexors and extensor muscles at four isokinetic speeds ( 15 ° –60 ° · s−1 ) and four joint position intervals ( 20 ° –60 ° of knee flexion ) . Eccentric flexor torque was normalized to the percentage of concentric flexor torque generated at each joint position interval for each speed tested ( flexor E-C ratio ) . In order to estimate the capacity of the knee flexors to resist active knee extension , the eccentric-flexor/concentric-extensor ratios were also computed for each joint position interval and speed ( flexor/extensor E-C ratio ) . The results revealed that eccentric torque surpassed concentric torque by 3%–144 % across movement speeds and joint position OUTPUT: Some of these deficits persisted up to 5 years after surgery . Knee flexor strength is more impaired after ACL reconstruction with hamstring grafts and quadriceps strength after BPTB ACL reconstruction . ConclusionS trength deficits of hip , knee and ankle muscles are reported after ACL reconstruction . Muscular strength test may be an important tool to determine if an athlete can return to competitive sports after ACL reconstruction INPUT: Abstract . This study documented postoperative morbidity during the first 4 months following anterior cruciate ligament ( ACL ) reconstruction using either patellar tendon or hamstring tendon autograft . Sixty-five patients undergoing primary arthroscopically assisted single-incision ACL reconstruction were r and omized to have a central third bone patellar tendon bone autograft ( PT ) or a doubled semitendinosus/doubled gracilis autograft ( HS ) . Postoperatively patients undertook a st and ard ' accelerated ' rehabilitation protocol . Patients were review ed after 2 weeks , 8 weeks , and 4 months . At each review the location and severity of general knee pain and the presence and severity of anterior knee pain ( AKP ) were recorded as were the presence and size of an effusion as well as the active and passive flexion and passive extension deficits compared to the contralateral limb . Pain on kneeling , KT-1000 measured side to side difference in anterior tibial displacement , isokinetic assessment of quadriceps and hamstring peak torque deficits , IKDC score and Cincinnati sports activity level were also recorded after 4 months . After 2 weeks more patients in the PT group complained of AKP and reported that the pain was more severe . After 8 weeks there was no significant difference between the groups for any variable . After 4 months the severity of general pain experienced and the incidence of pain on kneeling were greater in the PT group . The PT group also demonstrated a significantly greater quadriceps peak torque deficit at 240 ° /s . IKDC scores were higher in the HS group , but Cincinnati sports activity scores were higher in the PT group . Although we observed a lower morbidity in the HS group , primarily related to pain , the severity of pain in both groups was relatively low and , in light of the higher mean sports activity level observed in the PT group at 4 months the clinical impact of the difference may not be significant BACKGROUND There are no controlled , prospect i ve studies comparing the 10-year outcomes of anterior cruciate ligament ( ACL ) reconstruction using patellar tendon ( PT ) and 4-str and hamstring tendon ( HT ) autografts . HYPOTHESIS Comparable results are possible with HT and PT autografts . STUDY DESIGN Cohort study ; Level of evidence , 2 . METHODS One hundred eighty ACL-deficient knees that met inclusion criteria underwent ACL reconstruction ( 90 HT autograft , 90 PT autograft ) by one surgeon and were treated with an accelerated rehabilitation program . All knees were observed in a prospect i ve fashion with subjective , objective , and radiographic evaluation at 2 , 5 , 7 , and 10-year intervals . RESULTS At 10 years , there were no differences in graft rupture rates ( 7/90 PT vs. 12/90 HT , P = .24 ) . There were 20 contralateral ACL ruptures in the PT group , compared with 9 in the HT group ( P = .02 ) . In all patients , graft rupture was associated with instrumented laxity > 2 mm at 2 years ( P = .001 ) . Normal or near-normal function of the knee was reported in 97 % of patients in both groups . In the PT group , harvest-site symptoms ( P = .001 ) and kneeling pain ( P = .01 ) were more common than in the HT group . More patients reported pain with strenuous activities in PT knees than in HT knees ( P = .05 ) . Radiographic osteoarthritis was more common in PT knees than the HT-reconstructed knees ( P = .04 ) . The difference , however , was composed of patients with mild osteoarthritis . Other predictors of radiographic osteoarthritis were < 90 % single-legged hop test at 1 year and the need for further knee surgery . An " ideal " outcome , defined as an overall International Knee Documentation Committee grade of A or B and a radiographic grade of A at 10 years after ACL reconstruction , was associated with <3 mm of instrumented laxity at 2 years , the absence of additional surgery in the knee , and HT grafts . CONCLUSIONS It is possible to obtain excellent results with both HT and PT autografts . We recommend HT reconstructions to our patients because of decreased harvest-site symptoms and radiographic osteoarthritis Two commercially available knee ligament arthrometers ( KT-1000 MEDmetric Corporation , San Diego , California and Kneelax MR Systems , Haarlem , The Netherl and s ) were used to measure anterior tibial translation . In this study 91 subjects with no history of knee pathology were tested using both devices . Both normal knees were tested and comparison of recorded anterior translation ( millimeters ) was performed . Absolute numbers at forces of 67N , 89N , 134N , and manual maximum displacements were recorded . Side-to-side differences were calculated and data were compared . There was a significant difference found between the absolute values of each device . The KT-1000 was found to record greater values in millimeters of translation . Although the absolute values were significantly different , the side-to-side differences were not significantly different between devices Background : Numerous studies have compared patellar tendon ( PT ) and hamstring tendon ( HS ) anterior cruciate ligament ( ACL ) reconstructions in the short to midterm , but fewer long-term results have been published . Hypothesis : There will be no difference in functional outcome between ACL reconstruction performed with PT and HS grafts , but PT grafts will have more donor site morbidity . Study Design : R and omized controlled trial ; Level of evidence , 1 . Methods : Sixty-five patients undergoing ACL reconstruction were r and omized to receive either a PT graft or a 4-str and HS graft . Early results were reported at 4 , 8 , 12 , 24 , and 36 months . Forty OUTPUT:

The QT autograft detected comparable rate of Lachman test > 3 mm , Pivot shift test > 3 m and instrumental laxity > 3 mm . The QT autograft showed a lower rate of autograft failure above all . The QT autograft detected the reduced rate of AKP than the PT . Quadriceps tendon autograft may represent a feasible option for primary ACL reconstruction .

MS2_dynamic_1_shot4

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This study evaluated the efficacy , tolerability , and safety of darifenacin , an M3 selective receptor antagonist ( M3 SRA ) , in patients with overactive bladder ( OAB ) . In a multicenter , double-blind , placebo-controlled dose-ranging study , 439 adult OAB patients ( 85.4 % female ) were r and omized to darifenacin controlled-release tablets 7.5 mg ( n = 108 ) , 15 mg ( n = 107 ) or 30 mg ( n = 115 ) qd , or placebo ( n = 109 ) for 12 weeks . Darifenacin significantly reduced the median number of incontinence episodes/week ( −68.7 , −76.5 , and −77.3 % from baseline at 7.5 , 15 , and 30 mg , respectively , vs −46 % with placebo , all p < 0.01 ) and dose relatedly improved micturition frequency , frequency and severity of urgency , nocturia , and bladder capacity . Darifenacin was well tolerated . Adverse events were commonly mild to moderate dry mouth and constipation . There were no safety concerns . Darifenacin is effective and well tolerated in the treatment of OAB , with 7.5 and 15 mg doses offering flexibility of dosing for optimal treatment outcome Overactive bladder ( OAB ) has a significant impact on a patient ’s health-related quality of life ( HRQoL ) . This study assessed the HRQoL of Japanese OAB patients following 12 weeks ’ treatment with tolterodine extended release ( ER ) or oxybutynin . A total of 293 patients with symptoms of OAB were r and omized for treatment with tolterodine ER 4 mg once daily ( n=114 ) , oxybutynin 3 mg three times daily ( n=122 ) or a placebo ( n=57 ) . Treatment efficacy and safety assessment s were made over the 12-week period . HRQoL was assessed using the King ’s Health Question naire ( KHQ ) . Patients receiving tolterodine ER or oxybutynin showed a significant ( P<0.05 ) improvement in the Incontinence Impact , Role Limitations and most other KHQ domains compared with the placebo . These changes in HRQoL corresponded with significant ( P<0.05 ) improvements in micturition diary variables for patients receiving tolterodine ER and oxybutynin compared with placebo . Our findings demonstrate that Japanese OAB patients receiving tolterodine ER or oxybutynin experienced overall improvement in their quality of life The embarrassment and social stigma associated with urinary incontinence ( UI ) in overactive bladder syndrome ( OAB ) sufferers is a major reason for individuals to seek help for their condition . An analysis of 1,873 subjects with OAB with UI was conducted to assess the efficacy of solifenacin in reducing incontinence in a pooled population from four phase III clinical trials , stratified by severity of incontinence , urgency , and other key factors at baseline . Subjects were r and omized to either 5 or 10 mg of solifenacin once daily or placebo for 12 weeks . More than 50 % of the total population became continent at study end , with either dose of solifenacin ( P<0.01 vs placebo ) . Significant reductions in incontinence episodes and higher rates of attainment of continence vs placebo were observed irrespective of age or severity of incontinence or urgency at baseline with solifenacin treatment . Treatment was well tolerated , with the majority of adverse events being mild in nature . Solifenacin is an effective antimuscarinic agent for the treatment of incontinence associated with OAB PURPOSE In this phase 3 trial we assessed the efficacy of solifenacin 5 mg and 10 mg daily in patients with symptoms related to overactive bladder . In addition , we assessed the safety and acceptability of solifenacin . MATERIAL S AND METHODS The study was a multicenter , multinational , r and omized , double-blind , placebo controlled trial . Patients were r and omized to 12-week once daily treatment with solifenacin 5 mg , solifenacin 10 mg or placebo . The primary efficacy variable was changed from baseline to study end point in mean number of micturitions per 24 hours . Secondary efficacy variables included changes from baseline in mean number of urgency , nocturia and incontinence episodes per 24 hours , and mean volume voided per micturition . RESULTS Compared with changes obtained with placebo ( -1.59 ) , micturitions per 24 hours were statistically significantly decreased with solifenacin 5 mg ( -2.37 , p = 0.0018 ) and solifenacin 10 mg ( -2.81 , p = 0.0001 ) . A statistically significant decrease was observed in the number of incontinence episodes with both solifenacin doses ( 5 mg , p = 0.002 and 10 mg , p = 0.016 ) . This effect was also seen for episodes of urge incontinence ( 5 mg , p = 0.014 and 10 mg , p = 0.042 ) . Of patients reporting incontinence at baseline , fully 50 % achieved continence after treatment with solifenacin . Episodes of nocturia were statistically significantly decreased in patients treated with solifenacin 10 mg ( -0.71 , -38.5 % ) versus placebo ( -0.52 , -16.4 % , p = 0.036 ) . Episodes of urgency were statistically significantly reduced with solifenacin 5 mg ( -2.84 , -51 % , p = 0.003 ) and solifenacin OUTPUT: Tolterodine immediate release ( IR ) had a more favorable profile of adverse events than oxybutynin IR . Regarding different dosages of IR formulations , dose escalation might yield some limited improvements in the efficacy but at the cost of significant increase in the rate of adverse events . In the comparisons between IR and extended-release ( ER ) formulations , the latter showed some advantages , both in terms of efficacy and safety . With regard to the route of administration , use if a transdermal route of administration does not provide significant advantage over an oral one . With regard to IR formulations , dose escalation might yield some improvements in the efficacy with significant increase in the AE . INPUT: OBJECTIVES To investigate the effects of darifenacin controlled-release ( CR ) and oxybutynin extended-release ( ER ) on cognitive function ( particularly memory ) in older subjects . METHODS Healthy subjects ( n=150 ) > /=60 years were r and omised to darifenacin , oxybutynin ER or placebo in a multicentre , double-blind , double-dummy , parallel-group , 3-week study . Doses were administered according to US labels : oxybutynin ER 10 mg once daily ( od ) , increasing to 15 mg od then 20 mg od by week 3 ; darifenacin 7.5 mg od in weeks 1 and 2 , then 15 mg od in week 3 . The primary end point was accuracy on the Name-Face Association Test ( delayed recall ) at week 3 . RESULTS Results of the Name-Face Association Test at week 3 showed no significant difference between darifenacin and placebo on delayed recall ( mean difference , -0.06 , p=0.908 ) . In contrast , oxybutynin ER result ed in memory impairment , with significantly lower scores than placebo and darifenacin ( mean differences , -1.30 , p=0.011 and -1.24 , p=0.022 , respectively ) for delayed recall on the Name-Face Association Test at week 3 . Additional tests of delayed recall indicated significant memory impairment with oxybutynin ER versus placebo at certain time points , whereas darifenacin was similar to placebo . No between-treatment differences were detected in self-rated memory , demonstrating that subjects were unaware of memory deterioration . CONCLUSIONS While darifenacin had no significant effects on memory versus placebo , oxybutynin ER caused significant memory deterioration ( magnitude of effect comparable to brain aging of 10 years ) . The results also demonstrate that subjects may not recognise/report memory deterioration INTRODUCTION Anti-cholinergic medications have been associated with increased risks of cognitive impairment , premature mortality and increased risk of hospitalisation . Anti-cholinergic load associated with medication increases as death approaches in those with advanced cancer , yet little is known about associated adverse outcomes in this setting . METHODS A sub study of 112 participants in a r and omised control trial who had cancer and an Australia modified Karnofsky Performance Scale ( AKPS ) score ( AKPS ) of 60 or above , explored survival and health service utilisation ; with anti-cholinergic load calculated using the Clinician Rated Anti-cholinergic Scale ( modified version ) longitudinally to death . A st and ardised starting point for prospect ively calculating survival was an AKPS of 60 or above . RESULTS Baseline entry to the sub- study was a mean 62 + /- 81 days ( median 37 , range 1 - 588 ) days before death ( survival ) , with mean of 4.8 ( median 3 , SD 4.18 , range 1 - 24 ) study assessment s in this time period . Participants spent 22 % of time as an inpatient . There was no significant association between anti-cholinergic score and time spent as an inpatient ( adjusted for survival time ) ( p = 0.94 ) ; or survival time . DISCUSSION No association between anti-cholinergic load and survival or time spent as an inpatient was seen . Future studies need to include cognitively impaired population s where the risks of symptomatic deterioration may be more substantial BACKGROUND Observational studies report a relationship between anticholinergic drug scale ( ADS ) score and cognitive function . This study investigated whether a reduced ADS score improved cognitive function in a frail elderly population . METHODS This r and omized , controlled , single-blinded trial , recruited long-term residents with an ADS score of greater than or equal to 3 from 22 nursing homes in Norway . The participants were r and omly allocated ( 1:1 ) to intervention or control . The intervention was a pharmacist-initiated reduction of ADS score after multidisciplinary drug review s. Primary end point was Consortium to Establish a Registry for Alzheimer 's Disease 10-wordlist test for immediate recall . Secondary end points were Mini-Mental Sate Examination , delayed recall and recognition of words , saliva flow , and serum anticholinergic activity (SAA).The participants were retested after 4 and 8 weeks , and the study groups were compared after adjusting for baseline differences . RESULTS Eighty-seven patients were included . The median ADS score was reduced by 2 units ( p < .0001 ) in the intervention group and remained unchanged in the control group . After 8 weeks , the adjusted mean difference in immediate recall was 0.54 words between the intervention and control group ( 95 % confidence interval [ CI ] : -0.91 , 2.05 ; p = .48 ) . The study groups did not differ significantly in any of the other cognitive end points , salvia flow , or SAA at either follow-up ( p > .18 ) . CONCLUSION Pharmacist-initiated drug changes significantly reduced ADS score but did not improve cognitive function in nursing home residents . Moreover , the drug changes did not reduce SAA or mouth dryness significantly , which might indicate limited applicability of the ADS score to prevent prescription risks in this population PURPOSE Overactive bladder is common in the elderly population , which is susceptible to cognitive disorders and drug induced cognitive impairment . Existing overactive bladder treatments may cause adverse events , such as cognitive impairment , due to antagonism of the M1 receptor in the central nervous system . In this study we evaluated the effect of darifenacin , an M3 selective antagonist , on cognitive function in elderly volunteers without clinical dementia . MATERIAL S AND METHODS This double-blind , 3-period crossover study r and omized 12 OUTPUT:

medicines with anti-cholinergic properties have a significant adverse effect on cognitive and physical function , but limited evidence exists for delirium or mortality outcomes

MS2_dynamic_1_shot5

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract . Glucocorticoid-induced osteoporosis has been reported to be caused by enhanced bone resorption and suppressed bone formation . To clarify whether administration of vitamin K , which enhances bone formation , prevents prednisolone-induced loss of bone mineral density ( BMD ) , a r and omized , prospect i ve , controlled study was conducted on 20 patients with chronic glomerulonephritis scheduled for treatment with prednisolone . All patients were initially treated with 0.8 mg/kg body weight/day of prednisolone ( maximum of 40 mg ) for 4 weeks , tapering to 20 mg/day over approximately 6 weeks . Ten patients received prednisolone alone ( Group 1 ) , and the other 10 patients received prednisolone plus 15 mg of menatetrenone , vitamin K , three times per day ( Group 2 ) . BMD of the lumbar spine measured by dual-energy X-ray absorptiometry ( DXA ) and biochemical markers of bone metabolism in blood and urine were evaluated before and 10 weeks after administration of prednisolone alone or with menatetrenone . In Group 1 , treatment with prednisolone significantly reduced BMD of the lumbar spine from 1.14 ± 0.12 to 1.10 ± 0.11 g/cm2 ( P= 0.0029 ) . Serum intact osteocalcin and procollagen type I C-peptide ( PICP ) concentrations , biochemical markers of bone formation , were markedly reduced . A biochemical marker of bone resorption , urinary excretion of deoxypyridinoline , was significantly reduced . In Group 2 , prednisolone-induced reduction of BMD was prevented by menatetrenone administration ( 1.09 ± 0.09 to 1.07 ± 0.07 g/cm2 , P= 0.153 ) . Menatetrenone prevented reduction of PICP concentration by prednisolone but not in serum intact osteocalcin concentration and urinary excretion of deoxypyridinoline . Thus , treatment with prednisolone result ed in loss of BMD of the lumbar spine associated with suppression of both bone formation and bone resorption . Menatetrenone is a useful agent in preventing prednisolone-induced loss of BMD We have recently demonstrated that glucocorticoid ( GC ) suppresses bone formation and enhances bone resorption , with result ant bone loss . This altered bone turnover is not due to the action of parathyroid hormone ( PTH ) , but appears to be related to the suppression of osteoprotegerin ( OPG ) . As vitamin K2 ( menatetrenone ) has been used for the treatment of osteoporosis , the present study was carried out to evaluate the effect of vitamin K2 on GC-induced bone loss . Twenty patients with chronic glomerulonephritis treated with GC for the first time were chosen for this study . Ten patients received GC alone ( group A ) and the other 10 patients each received 15 mg of vitamin K2 per day in addition to GC ( group B ) . Markers of bone metabolism , including serum OPG , osteocalcin ( OC ) , bone-specific alkaline phosphatase activity ( BAP ) , PTH , tartrate-resistant acid phosphatase ( TRAP ) , and bone mineral density ( BMD ) , were measured before and during the treatment . OPG was significantly decreased in group A ( P < 0.001 ) , while no significant change was seen in group B. TRAP was markedly increased in both groups , more particularly in group A ( P < 0.01 ) . PTH was decreased in group A , but was increased in group B. OC was decreased at month 1 but subsequently increased until month 12 in both groups . BAP had decreased at month 3 in group A ( P < 0.05 ) , but not in group B. BMD of the lumbar spine was significantly reduced after 6 months ( P < 0.01 ) , and 12 months ( P < 0.001 ) of treatment in group A , whereas there was no remarkable change in group B. The present study demonstrated that the inhibition exerted by vitamin K2 of the reduction in OPG induced by GC may , at least in part , play a role in the prevention and treatment of GC-induced bone loss The purpose of this study was to evaluate the influence of gamma-glutamyl transferase ( GGCX ) gene polymorphisms on the response of serum undercarboxylated osteocalcin ( ucOC ) and bone turnover markers 3 months after treatment with menatetrenone . One hundred and forty postmenopausal Thai women were enrolled and assigned to receive 45 mg/day treatment of menatetrenone ( MK-4 ) concurrently with calcium 1.2 g and vitamin D 400 IU for 3 months . Demographic characteristics , GGCX genotyping , serum bone turnover markers and ucOC levels were obtained from all participants at baseline . We evaluated the reduction of ucOC at 3 months and the reduction of beta-CTx and P1NP at 1 and 3 months . The responses were compared between the different genotypes of GG and GA + AA groups . There was a significant reduction of serum ucOC , beta-CTx and P1NP from the baseline at 3 months ( p < 0.001 ) though there was no significant difference between genotypes ( GG vs. GA + AA ; p > 0.05 ) . Nonetheless , a subgroup analysis of postmenopausal women who 65 years of age or over ( N = 37 ) revealed a significant difference between the two groups in the reduction of ucOC . Menatetrenone significantly reduced serum ucOC as well as beta-CTX and P1NP from the baseline . GGCX polymorphism appeared to have an influence over the reduction of ucOC especially in older women ( age ≥65 ) . Furthermore , the groups which have “ A ” OUTPUT: A meta- analysis study , but not a systematic review study , showed efficacy against vertebral and non-vertebral fractures mainly in postmenopausal women with osteoporosis . There was no available evidence for men with osteoporosis . The present review of the literature revealed some evidence of a positive effect of menatetrenone on the skeleton of postmenopausal women and in patients treated with glucocorticoid . EXPERT OPINION Menatetrenone is considered to be a second-line medicine for postmenopausal osteoporotic women with an increased risk for vertebral fractures INPUT: We have recently demonstrated that glucocorticoid ( GC ) suppresses bone formation and enhances bone resorption , with result ant bone loss . This altered bone turnover is not due to the action of parathyroid hormone ( PTH ) , but appears to be related to the suppression of osteoprotegerin ( OPG ) . As vitamin K2 ( menatetrenone ) has been used for the treatment of osteoporosis , the present study was carried out to evaluate the effect of vitamin K2 on GC-induced bone loss . Twenty patients with chronic glomerulonephritis treated with GC for the first time were chosen for this study . Ten patients received GC alone ( group A ) and the other 10 patients each received 15 mg of vitamin K2 per day in addition to GC ( group B ) . Markers of bone metabolism , including serum OPG , osteocalcin ( OC ) , bone-specific alkaline phosphatase activity ( BAP ) , PTH , tartrate-resistant acid phosphatase ( TRAP ) , and bone mineral density ( BMD ) , were measured before and during the treatment . OPG was significantly decreased in group A ( P < 0.001 ) , while no significant change was seen in group B. TRAP was markedly increased in both groups , more particularly in group A ( P < 0.01 ) . PTH was decreased in group A , but was increased in group B. OC was decreased at month 1 but subsequently increased until month 12 in both groups . BAP had decreased at month 3 in group A ( P < 0.05 ) , but not in group B. BMD of the lumbar spine was significantly reduced after 6 months ( P < 0.01 ) , and 12 months ( P < 0.001 ) of treatment in group A , whereas there was no remarkable change in group B. The present study demonstrated that the inhibition exerted by vitamin K2 of the reduction in OPG induced by GC may , at least in part , play a role in the prevention and treatment of GC-induced bone loss BACKGROUND Osteoporotic structural damage and bone fragility result from reduced bone formation and increased bone resorption . In a phase 2 clinical trial , strontium ranelate , an orally active drug that dissociates bone remodeling by increasing bone formation and decreasing bone resorption , has been shown to reduce the risk of vertebral fractures and to increase bone mineral density . METHODS To evaluate the efficacy of strontium ranelate in preventing vertebral fractures in a phase 3 trial , we r and omly assigned 1649 postmenopausal women with osteoporosis ( low bone mineral density ) and at least one vertebral fracture to receive 2 g of oral strontium ranelate per day or placebo for three years . We gave calcium and vitamin D supplements to both groups before and during the study . Vertebral radiographs were obtained annually , and measurements of bone mineral density were performed every six months . RESULTS New vertebral fractures occurred in fewer patients in the strontium ranelate group than in the placebo group , with a risk reduction of 49 percent in the first year of treatment and 41 percent during the three-year study period ( relative risk , 0.59 ; 95 percent confidence interval , 0.48 to 0.73 ) . Strontium ranelate increased bone mineral density at month 36 by 14.4 percent at the lumbar spine and 8.3 percent at the femoral neck ( P<0.001 for both comparisons ) . There were no significant differences between the groups in the incidence of serious adverse events . CONCLUSIONS Treatment of postmenopausal osteoporosis with strontium ranelate leads to early and sustained reductions in the risk of vertebral fractures It has been previously shown that the level of circulating undercarboxylated osteocalcin ( ucOC ) is elevated in elderly women in comparison with young , healthy , premenopausal ones . To underst and the mechanism of the increase in the ucOC in the elderly and to assess its potential consequences on bone fragility , we have measured ucOC in the sera of 195 elderly institutionalized women 70 - 101 yr of age . In 45 women ( 23 % ) serum ucOC was above the upper limit of the normal range for young women . The level of ucOC was negatively correlated with 25OHD ( r = -0.32 , P < 0.001 ) even after excluding the effect of age , parathyroid hormone ( PTH ) , and creatinine by partial correlation ( r = -0.24 , P < 0.002 ) . During an 18-mo follow-up , 15 women sustained a hip fracture and their baseline ucOC level was higher ( P < 0.01 ) in women who subsequently sustained hip fracture than in the nonfracture group contrasting with no significant differences for serum calcium , phosphate , alkaline phosphatase , creatinine , PTH , 250HD , and total and carboxylated OC . The risk of hip fracture was increased in women with elevated ucOC ( relative ratio 5.9 , 99.9 % Cl 1.5 - 22.7 , P < 0.001 ) . During 1 yr of calcium/vitamin D2 treatment , ucOC decreased ( P < 0.05 ) , especially in those with the initially increased values ( from 2.22 + /- 0.35 to 1.41 + /- 0.29 ng/ml , P < 0.005 ) contrasting with an increase in the placebo group ( P < 0.05 ) . In conclusion , the increase in ucOC in the elderly reflects not only some degree of vitamin K deficiency but also their poor vitamin D status , suggesting that vitamin D may be important , either directly or indirectly through its effect on bone turnover , for OUTPUT:

This systematic review suggests that supplementation with phytonadione and menaquinone-4 reduces bone loss . In the case of the latter , there is a strong effect on incident fractures among Japanese patients

MS2_dynamic_1_shot6

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The relative accuracy of r and omized control trials ( RCTs ) and historical control trials ( HCTs ) in determining effective therapies has not been compared since there is no external verification of efficacy . We review ed six therapies studied by both methods . Most HCTs concluded therapy was better than control , but few RCTs agreed . We calculated sensitivity and specificity for each type of trial by combining published results with all possible combinations of effectiveness . The sensitivity of HCTs was 0.80 to 1.00 ( mean , 0.90 ) and specificity was 0.0 to 0.27 ( mean , 0.11 ) . The sensitivity of RCTs was 0.0 to 0.27 ( mean , 0.12 ) and specificity was 0.67 to 1.00 ( mean , 0.88 ) . Defects of RCTs are more easily corrected than those of HCTs . Readers should consider trial design and the probability of errors when deciding how much credence to give to a clinical trial CONTEXT Medical evidence may be biased over time if completion and publication of r and omized efficacy trials are delayed when results are not statistically significant . OBJECTIVE To evaluate whether the time to completion and the time to publication of r and omized phase 2 and phase 3 trials are affected by the statistical significance of results and to describe the natural history of such trials . DESIGN Prospect i ve cohort of r and omized efficacy trials conducted by 2 trialist groups from 1986 to 1996 . SETTING Multicenter trial groups in human immunodeficiency virus infection sponsored by the National Institutes of Health . PATIENTS A total of 109 efficacy trials ( total enrollment , 43708 patients ) . MAIN OUTCOME MEASURES Time from start of enrollment to completion of follow-up and time from completion of follow-up to peer- review ed publication assessed with survival analysis . RESULTS The median time from start of enrollment to publication was 5.5 years and was substantially longer for negative trials than for results favoring an experimental arm ( 6.5 vs 4.3 years , respectively ; P<.001 ; hazard ratio for time to publication for positive vs negative trials , 3.7 ; 95 % confidence interval [ CI ] , 1.8 - 7.7 ) . This difference was mostly attributable to differences in the time from completion to publication ( median , 3.0 vs 1.7 years for negative vs positive trials ; P<.001 ) . On average , trials with significant results favoring any arm completed follow-up slightly earlier than trials with nonsignificant results ( median , 2.3 vs 2.5 years ; P=.045 ) , but long-protracted trials often had low event rates and failed to reach statistical significance , while trials that were terminated early had significant results . Positive trials were su bmi tted for publication significantly more rapidly after completion than were negative trials ( median , 1.0 vs 1.6 years ; P=.001 ) and were published more rapidly after su bmi ssion ( median , 0.8 vs 1.1 years ; P=.04 ) . CONCLUSION Among r and omized efficacy trials , there is a time lag in the publication of negative findings that occurs mostly after the completion of the trial follow-up Meta-analytic investigations sometimes use assessment s of research quality according to a formal protocol as a tool for improving research synthesis . We asked whether a particular quality scoring system could have a direct use in adjusting the summary estimates of a treatment difference . In an empirical study of the relation of quality scores to treatment differences in published meta-analyses of 7 groups of controlled r and omized clinical trials comprising 107 primary studies , we found no relation between treatment difference and overall quality score . We also found no relation between quality score and variation in treatment difference . The level of quality scores has increased at a rate of 9 % per decade for three decades , averaging 0.51 on a scale of 0 to 1 for the 1980s , and leaving much room for improvement . Nevertheless , attention to quality of studies by editors , review ers , and authors may be raising both the level of research done and quality of the reports OBJECTIVE To determine whether crossover trials with simple pooling of data over different study periods leads to a different estimate of treatment effect compared with parallel group trials in infertility research using pregnancy as the outcome measure . DESIGN An observational study using nine overviews that included trials with both crossover and parallel group design s. These overviews comprised 17 crossover and 17 parallel group trials . In total , there were 5,291 outcomes including 775 pregnancies . The association between study design and treatment effect estimate was analyzed using multiple logistic regression , controlling for differences in the therapeutic interventions and variations in the method ological quality of the trials . SETTING Infertile patients in an academic research environment . PATIENTS Infertile patients undergoing treatment efficacy evaluation in controlled trials . INTERVENTIONS R and om allocation to a variety of treatments including clomiphene citrate , hCG , IUI , tamoxifen , and bromocriptine . MAIN OUTCOME MEASURE Estimate of bias between study design s , based on the interaction of study design and treatment in the logistic regression model . RESULTS Crossover trials produced a larger average estimate of treatment effect compared with trials with a parallel group design , overestimating the odds ratio by 74 % ( 95 % confidence interval , 2 % to 197 % ) . CONCLUSION The use of a crossover design for evaluating infertility treatments with outcomes that prevent patients from completing later phases of the trial should be avoided because it leads to exaggerated estimates of treatment effect and may result in erroneous inferences and clinical decisions . Furthermore , the type of study design should be taken into account when assessing the method ological quality of therapy trials in infertility To compare the use of r and omized controls ( RCTs ) and historical controls ( HCTs ) for clinical trials , we search ed the literature for therapies studied by OUTPUT: Some of these differences were due to a poorer prognosis in the control groups in the non-r and omised trials . Comparisons of adequately and inadequately concealed allocation in r and omised trials of the same intervention provided high quality evidence that concealment can be crucial in achieving similar treatment groups and , therefore , unbiased estimates of treatment effects . Studies with inadequate concealment tended to overestimate treatment effects . Comparisons of high and low quality trials of the same intervention have found important differences in estimates of effect , but it is not possible to determine the extent to which these differences can be attributed to r and omisation or concealment of allocation . Omitting comparisons between r and omised trials and non-r and omised trials using historical controls did not substantially alter the results or conclusions of our review . On average , non-r and omised trials and r and omised trials with inadequate concealment of allocation tend to result in larger estimates of effect than r and omised trials with adequately concealed allocation . However , it is not generally possible to predict the magnitude , or even the direction , of possible selection biases and consequent distortions of treatment effects INPUT: To compare the use of r and omized controls ( RCTs ) and historical controls ( HCTs ) for clinical trials , we search ed the literature for therapies studied by both methods . We found six therapies for which 50 RCTs and 56 HCTs were reported . Forty-four of 56 HCTs ( 79 percent ) found the therapy better than the control regimen , but only 10 of 50 RCTs ( 20 percent ) agreed . For each therapy , the treated patients in RCTs and HCTs of the same therapy was largely due to differences in outcome for the control groups , with HCT control patients generally doing worse than the RCT control groups . Adjustment of the outcomes of the HCTs for prognostic factors , when possible , did not appreciably change the results . The data suggest that biases in patient selection may irretrievably weight the outcome of HCts in favor of new therapies . RCTs may miss clinical ly important benefits because of inadequate attention to sample size . The predictive value of each might be improved by reconsidering the use of p less than 0.05 as the significance level for all types of clinical trials , and by the use of confidence intervals around estimates of treatment effects A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL sessions . Further research is needed to answer the question of “ intensity versus type of exercise ” by comparing different intervention programs , with similar intensity Study Design . The study was carried out as an open , r and omized , multicenter , parallel‐group study with an observation period of 12 months . Four Norwegian physiotherapy institutes took part . Patients were subsequently followed for 12 months of home exercise on their own , without the supervision of a physiotherapist . Objectives . 1 ) To investigate and compare the effects of two different exercise programs on low back problems in patients after a 1‐year training program under the supervision of a physiotherapist . 2 ) To investigate the effect supervision by , and motivation from , physiotherapists has on training compliance and efficacy . Summary of Background Data . After ordinary physiotherapy treatment for low back problems , patients were r and omly allocated either to a conventional training program design ed by physiotherapists or to a training program using a new Norwegian‐developed training apparatus called the TerapiMaster . The study included 153 patients with low back problems , all of whom had been referred to physiotherapy by their general practitioners . One hundred twenty‐six patients were followed for an additional 12 months when performing home exercise programs on their own . Methods . Monitoring patient satisfaction with the training program , compliance with the program , and absenteeism from work during the training period . Results . Patient satisfaction with both training programs was high , with about 83 % of participating patients completing the study in accordance with the protocol . Mean absenteeism ( SD ) during the preceding year totaled 82.5 days ( 19.8 ) in the conventional training group and 61.6 days ( 14.7 ) in the TerapiMaster group . Significant reductions to 17.2 days ( 6.0 ) and 15.4 days ( 5.3 ) in the two groups , respectively , were recorded during the training period , corresponding to a 75 % to 80 % reduction compared with the preceding 1‐year period . Mean absenteeism showed a further significant decline during the 12‐month period without supervised training . The average values were 9.9 days ( 3.2 ) for conventional training and 9.3 days ( 3.1 ) for the TerapiMaster , respectively . Conclusions . Both exercise programs reduced absenteeism significantly ( 75‐80 % ) . No difference in the effects of the two different programs was discernible . Regular follow‐up through encouragement and variation in the training programs appear to be important factors for motivating patients to adhere to regular exercise programs for low back problems . This thesis was corroborated by the 12‐month study of unsupervised exercise CONTEXT Low back pain is a frequent and costly health problem . Prevention of low back pain is important both for the individual patient and from an economic perspective . OBJECTIVE To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry . DESIGN A r and omized controlled trial with a factorial design . SETTING The cargo department of an airline company in the Netherl and s. PARTICIPANTS A total of 312 workers were r and omized , of whom 282 were available for the 6-month follow-up . INTERVENTIONS Subjects were r and omly assigned to 4 groups : ( 1 ) education ( lifting instructions ) and lumbar support , ( 2 ) education , ( 3 ) lumbar support , and ( 4 ) no intervention . Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours . Lumbar supports were recommended to be used during working hours for 6 months . MAIN OUTCOME MEASURES Low back pain incidence and sick leave because of back pain during the 6-month intervention period . RESULTS Compliance with wearing the lumbar support at least half the time was 43 % . In the 282 subjects for whom data were available , no statistically significant differences in back pain incidence ( 48 [ 36 OUTPUT:

The trials suggest that work place exercise is effective , braces and education are ineffective , and workplace modification plus education is of unknown value in preventing low back pain

MS2_dynamic_1_shot7

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Better self management could improve quality of life ( QoL ) and reduce hospital admissions in chronic obstructive pulmonary disease ( COPD ) , but the best way to promote it remains unclear . AIM To explore the feasibility , effectiveness and cost effectiveness of a novel , layperson-led , theoretically driven COPD self-management support programme . DESIGN AND SETTING Pilot r and omised controlled trial in one UK primary care trust area . METHOD Patients with moderate to severe COPD were identified through primary care and r and omised 2:1 to the 7-week-long , group intervention or usual care . Outcomes at baseline , 2 , and 6 months included self-reported health , St George 's Respiratory Question naire ( SGRQ ) , EuroQol , and exercise . RESULTS Forty-four per cent responded to GP invitation , 116 were r and omised : mean ( st and ard deviation [ SD ] ) age 69.5 ( 9.8 ) years , 46 % male , 78 % had unscheduled COPD care in the previous year . Forty per cent of intervention patients completed the course ; 35 % attended no sessions ; and 78 % participants completed the 6-month follow-up question naire . Results suggest that the intervention may increase both QoL ( mean EQ-5D change 0.12 ( 95 % confidence interval [ CI ] = -0.02 to 0.26 ) higher , intervention versus control ) and exercise levels , but not SGRQ score . Economic analyses suggested that with thresholds of £ 20 000 per quality -adjusted life-year gained , the intervention is likely to be cost-effective . CONCLUSION This intervention has good potential to meet the UK National Institute for Health and Clinical Excellence criteria for cost effectiveness , and further research is warranted . However , to make a substantial impact on COPD self-management , it will also be necessary to explore other ways to enable patients to access self-management education Aims : The main objective of this study was to investigate whether a comprehensive self-management programme , including self-treatment guidelines for exacerbations and a fitness programme , is an efficient treatment option for chronic obstructive pulmonary disease ( COPD ) patients . Method : We r and omly allocated 248 COPD patients to either self-management ( 127 ) or usual care ( 121 ) . Data on preference-based utilities ( EuroQol-5D ) , health-related quality of life ( HRQoL ) , health-care re source use and productivity losses associated with exacerbations were prospect ively collected . Quality -adjusted life years ( QALYs ) were calculated . The economic analysis took the societal perspective and the observation period was one year . Results : As we observed that the groups were equally effective in terms of QALYs and HRQoL ( SGRQ ) , we described a cost minimization analysis only . The self-management programme-specific costs amounted to 6642 per patient . In the base-case cost analysis , the incremental cost difference amounted to 838 per patient per year in favour of usual care . When only direct medical costs were included , the incremental annual cost of self-managementrelative to usual care was 179 per person per year . If time costs for the fitness programme were set to zero , the costs for self-management diminished to 542 . Sensitivity analysis showed that these results were robust to changes in the underlying assumptions . Conclusion : We conclude that the COPE self-management programme is not an efficient treatment option for moderate to severe COPD patients who rate their HRQoL relatively high . The programme was twice as expensive as usual care and had no measurable beneficial effects on QALYs or Objectives Pulmonary rehabilitation ( PR ) provides benefit for patients with chronic obstructive pulmonary disease ( COPD ) in terms of quality of life ( QoL ) and exercise capacity ; however , the effects diminish over time . Our aim was to evaluate a maintenance programme for patients who had completed PR . Setting Primary and secondary care PR programmes in Norfolk . Participants 148 patients with COPD who had completed at least 60 % of a st and ard PR programme were r and omised and data are available for 110 patients . Patients had greater than 20 pack year smoking history and less than 80 % predicted forced expiratory volume in 1 s but no other significant disease or recent respiratory tract infection . Interventions Patients were r and omised to receive a maintenance programme or st and ard care . The maintenance programme consisted of 2 h ( 1 h individually tailored exercise training and 1 h education programme ) every 3 months for 1 year . Primary and secondary outcome measures The Chronic Respiratory Question naire ( CRQ ) ( primary outcome ) , endurance shuttle walk test ( ESWT ) , EuroQol ( EQ5D ) , hospital anxiety and depression score ( HADS ) , body mass index ( BMI ) , body fat , activity levels ( overall score and activity diary ) and exacerbations were assessed before and after 12 months . Results There was no statistically significant difference between the groups for the change in CRQ dyspnoea score ( primary end point ) at 12 months which amounted to 0.19 ( −0.26 to 0.64 ) units or other domains of the CRQ . There was no difference in the ESWT duration ( −10.06 ( −191.16 to 171.03 ) seconds ) , BMI , body fat , EQ5D , MET-minutes , activity rating , HADS , exacerbations or admissions . Conclusions A maintenance programme of three monthly 2 h sessions does not improve outcomes in patients with COPD after 12 months . We do not recommend that our maintenance programme is adopted . Other methods of sustaining the benefits of PR are required . Trial registration number NCT00925171 The Global Initiative for Chronic Obstructive Lung Disease ( GOLD ) serves as a guide to treat and manage different severity classes of patients with COPD . It was suggested that the five categories of FEV1 % predicted ( GOLD 0–4 ) , can be applied OUTPUT: Meta-analyses of COPD stages utility values showed influence of airway obstruction on utility value . INPUT: BACKGROUND There is some evidence that quality of life ( QOL ) in patients with chronic obstructive pulmonary disease ( COPD ) may predict clinical outcomes and use of re sources . This study examined whether QOL scores could prospect ively predict re-admission for COPD or death within 12 months of an original admission , and whether QOL scores predicted home nebuliser provision . METHODS The study was carried out in all acute medical wards of Aberdeen Royal Infirmary , Woodend and City Hospitals , Aberdeen over 12 months . A total of 377 patients admitted with an exacerbation of COPD were identified in this time , 111 of whom were not included in the study because they refused the interview or died before discharge . The remaining 266 patients completed the St George 's Respiratory Question naire ( SGRQ ) . Information on spirometric parameters , nebuliser provision at discharge , provision of domiciliary oxygen , and re-admission within 12 months was collected from patient notes . RESULTS The mean age of the patients was 68 years and 53 % were men . The mean ( SD ) forced expiratory volume in one second ( FEV1 ) was 38.8 (18.0)% predicted and forced vital capacity ( FVC ) was 58.9 (23.8)% predicted . Higher ( worse ) scores on the SGRQ were significantly related to re-admission for COPD in the next 12 months ( difference = 4.8 , 95 % CI 1.6 to 8.0 ) . Patients who were re-admitted and died from COPD did not differ in SGRQ scores from those who were re-admitted and survived for more than 12 months . Re-admission was not related to sex , age , or pulmonary function . One hundred and thirty eight patients did not have a home nebuliser before admission . Of these , 14 were provided with a home nebuliser at discharge . Patients provided with nebulisers had significantly worse SGRQ scores and worse FVC . The 41 patients given domiciliary oxygen did not differ in SGRQ or spirometric parameters . Logistic regression analysis of the three SGRQ subscales ( Symptom , Impact and Activity ) , adjusting for lung function , age and sex , showed that all three subscales were significantly related to hospital readmission and that Impact scores were related to nebuliser provision . Women did not differ from men in Symptom scores on the SGRQ but differed markedly on the Activity and Impact scales . CONCLUSIONS It is concluded that poor scores on the SGRQ , a QOL scale which measures patient distress and coping , are associated with re-admission for COPD and use of re sources such as nebulisers , independent of physiological measures of disease severity PURPOSE Self-directed and supervised exercise were compared with usual care in a clinical trial design ed to evaluate the effect of structured exercise on physical functioning and other dimensions of health-related quality of life in women with stages I and II breast cancer . PATIENTS AND METHODS One hundred twenty-three women with stages I and II breast cancer completed baseline evaluations of generic and disease- and site-specific health-related quality of life , aerobic capacity , and body weight . Participants were r and omly allocated to one of three intervention groups : usual care ( control group ) , self-directed exercise , or supervised exercise . Quality of life , aerobic capacity , and body weight measures were repeated at 26 weeks . The primary outcome was the change in the Short Form-36 physical functioning scale between baseline and 26 weeks . RESULTS Physical functioning in the control group decreased by 4.1 points , whereas it increased by 5.7 points and 2.2 points in the self-directed and supervised exercise groups , respectively ( P = .04 ) . Post hoc analysis showed a moderately large ( and clinical ly important ) difference between the self-directed and control groups ( 9.8 points ; P = .01 ) and a more modest difference between the supervised and control groups ( 6.3 points ; P = .09 ) . No significant differences between groups were observed for changes in quality of life scores . In a secondary analysis of participants stratified by type of adjuvant therapy , supervised exercise improved aerobic capacity ( + 3.5 mL/kg/min ; P = .01 ) and reduced body weight ( -4.8 kg ; P < .05 ) compared with usual care only in participants not receiving chemotherapy . CONCLUSION Physical exercise can blunt some of the negative side effects of breast cancer treatment , including reduced physical functioning . Self-directed exercise is an effective way to improve physical functioning compared with usual care . In participants not receiving chemotherapy , supervised exercise may increase aerobic capacity and reduce body weight compared with usual care We have developed a rehabilitation programme at home and have investigated its effects on quality of life ( QOL ) , lung function , and exercise tolerance in patients with chronic obstructive pulmonary disease ( COPD ) . We studied 43 patients with severe airflow obstruction : forced expiratory volume in one second ( FEV1 ) 1.3 + /- 0.4 l ( mean + /- SD ) , FEV1/inspiratory vital capacity ( IVC ) 37 + /- 7.9 % . After stratification , 28 patients were r and omly allocated in a home rehabilitation programme for 12 weeks . Fifteen patients in a control group received no rehabilitation . The rehabilitation group received physiotherapy by the local physiotherapist , and supervision by a nurse and a general practitioner . Quality of life was assessed by the four dimensions of the Chronic Respiratory Question naire ( CRQ ) . We found a highly significant improvement in the rehabilitation group compared to the control group for the dimensions dyspnoea , emotion , and mastery . Lung function showed no changes in the rehabilitation group . The exercise tolerance improved significantly in the rehabilitation group compared to the control group . The improvement in quality of life was not correlated with the improvement in exercise tolerance . Rehabilitation of COPD patients at home may improve quality of life ; this improvement is not correlated with an OUTPUT:

There was no consistent relationship with factors such as disease-specific or generic instrument or the number of response options . Negative changes were not associated with larger ESs . Population -based estimation procedures and brief follow-up were associated with smaller ESs , and acute conditions with larger ESs .

MS2_dynamic_1_shot8

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: CONTEXT The generalized type of social phobia ( social anxiety disorder ) is a severe and often disabling form of social anxiety that affects approximately 5 % of the general population . Earlier research has shown monoamine oxidase inhibitors or benzodiazepines to be effective in treating this condition , but neither has achieved widespread use . OBJECTIVE To compare the efficacy of paroxetine , a selective serotonin reuptake inhibitor , with placebo in adults with generalized social phobia . DESIGN Twelve-week , multicenter , r and omized , double-blind trial . SETTING Thirteen centers across the United States and 1 in Canada . PARTICIPANTS Between April 13 , 1995 , and February 28 , 1996 , 187 persons meeting Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria for generalized social phobia were r and omized ( and 183 returned for at least 1 efficacy assessment ) to treatment . INTERVENTION After a 1-week , single-blind , placebo , run-in period , patients received a double-blind , 11-week course of either paroxetine or matching-image placebo . The initial daily dosage of paroxetine ( or placebo ) was 20 mg with increases of 10 mg/d weekly ( flexible dosing to a maximum of 50 mg/d ) permitted after the second week of treatment . MAIN OUTCOME MEASURES Number of responders based on the Clinical Global Impression Global Improvement Item ( " much improved " or " very much improved " ) ; mean change from baseline on the Liebowitz Social Anxiety Scale total score . RESULTS Fifty ( 55.0 % ) of 91 persons taking paroxetine and 22 ( 23.9 % ) of 92 persons taking placebo were much improved or very much improved at the end of treatment ( odds ratio [ OR ] , 3.88 ; 95 % confidence interval [ CI ] , 2.81 - 5.36 ) . Mean Liebowitz Social Anxiety Scale total scores were reduced by 39.1 % ( the mean baseline score of 78.0 declined by a mean of 30.5 points at follow-up ) in the paroxetine group compared with 17.4 % ( the mean baseline score of 83.5 declined 14.5 points at follow-up ) in the placebo group , a difference of 21.7 % ( 95 % CI , 8.7%-34.7 % ) favoring paroxetine . CONCLUSIONS Paroxetine is an effective treatment for patients with generalized social phobia . Short-term ( ie , 11-week ) treatment results in substantial and clinical ly meaningful reductions in symptoms and disability . Future research should test whether these may be further reduced by extended treatment or supplementation with specific educational-cognitive-behavioral techniques Rationale Seasonal affective disorder ( SAD ) is a relatively common cyclical depressive illness characterized by seasonal depressions during winter . The disorder is commonly responsive to light therapy , but antidepressant drug efficacy has not been definitely established . Serotonin selective re-uptake inhibitors are potentially efficacious treatments for SAD . Objectives The objective of this study was to evaluate the efficacy , tolerability and safety of sertraline treatment for SAD . Methods One hundred and eighty seven out patients with seasonal pattern recurrent winter depression ( DSM-III-R defined ) and a minimum 29-item Hamilton depression scale ( SIGH-SAD version ) score of 22 were r and omized to 8 weeks treatment with either sertraline or placebo in a double-blind , multi-country , multi-center , parallel-group , flexible dose ( 50–200 mg once daily ) study . Efficacy was investigated using physician and patient-rated scales measuring depression , anxiety and symptoms characteristic of seasonal affective disorder . Results Sertraline produced a significantly greater response than placebo at endpoint as measured by changes in the 29-item and 21-item Hamilton depression scales , the clinical global impression ( CGI ) severity scale , the Hamilton anxiety scale , and the hospital anxiety and depression scale . The proportion of sertraline-treated subjects achieving a response on the CGI improvement rating ( ratings of 1 or 2 ) at endpoint ( last observation carried forward ) was significantly greater than that of the placebo group . Overall sertraline was well tolerated with the most frequent placebo adjusted adverse events , being nausea , diarrhea , insomnia and dry mouth . Adverse events were mostly mild to moderate and transient . Conclusions Sertraline pharmacotherapy has been demonstrated to be an effective and well-tolerated therapy for out patients with SAD . As such , sertraline offers an important pharmacological option in the clinical management of this condition The efficacy of paroxetine in the treatment of obsessive-compulsive disorder in Western population s is well established . The present study compares the efficacy and safety of paroxetine with placebo in the treatment of obsessive-compulsive disorder in Japanese patients . Patients aged 16 years or older who met Diagnostic and Statistical Manual of Mental Disorders ( 4th edn ; DSM-IV ) criteria for obsessive-compulsive disorder and had a Yale-Brown Obsessive-Compulsive Scale ( Y-BOCS ) score of > /=16 were r and omized to receive 12 weeks ' therapy in a double-blind manner . Paroxetine 20 - 50 mg/day or placebo was administered following a 1 week , placebo run-in phase . One hundred and ninety-one patients were r and omized to either paroxetine or placebo , 188 patients were assessed as the full analysis set ( FAS ) and 144 patients completed the 12 week study . After adjustment for the Y-BOCS total score at baseline , reductions in obsessive-compulsive total score at week 6 and at OUTPUT: Systematic assessment led to higher rates than less systematic assessment . Conclusion : Adverse effect profiles reported in clinical trials are strongly influenced by expectations from investigators and patients . This difference can not be attributed to ascertainment methods . Adverse effect patterns of the drug group are closely related to adverse effects of the placebo group . These results question the validity of the assumption that adverse effects in placebo groups reflect the ‘ drug-unspecific effects ’ INPUT: Abstract This long-term extension of an 8-week r and omized , naturalistic study in patients with panic disorder with or without agoraphobia compared the efficacy and safety of clonazepam ( n = 47 ) and paroxetine ( n = 37 ) over a 3-year total treatment duration . Target doses for all patients were 2 mg/d clonazepam and 40 mg/d paroxetine ( both taken at bedtime ) . This study reports data from the long-term period ( 34 months ) , following the initial 8-week treatment phase . Thus , total treatment duration was 36 months . Patients with a good primary outcome during acute treatment continued monotherapy with clonazepam or paroxetine , but patients with partial primary treatment success were switched to the combination therapy . At initiation of the long-term study , the mean doses of clonazepam and paroxetine were 1.9 ( SD , 0.30 ) and 38.4 ( SD , 3.74 ) mg/d , respectively . These doses were maintained until month 36 ( clonazepam 1.9 [ SD , 0.29 ] mg/d and paroxetine 38.2 [ SD , 3.87 ] mg/d ) . Long-term treatment with clonazepam led to a small but significantly better Clinical Global Impression (CGI)–Improvement rating than treatment with paroxetine ( mean difference : CGI-Severity scale −3.48 vs −3.24 , respectively , P = 0.02 ; CGI-Improvement scale 1.06 vs 1.11 , respectively , P = 0.04 ) . Both treatments similarly reduced the number of panic attacks and severity of anxiety . Patients treated with clonazepam had significantly fewer adverse events than those treated with paroxetine ( 28.9 % vs 70.6 % , P < 0.001 ) . The efficacy of clonazepam and paroxetine for the treatment of panic disorder was maintained over the long-term course . There was a significant advantage with clonazepam over paroxetine with respect to the frequency and nature of adverse events Background Anxiety disorders are among the most common psychiatric illnesses , with generalized anxiety disorder ( GAD ) being one of the most common . Sleep disturbances are highly prevalent in GAD patients . While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials , mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin . Thus , the objective of this study was to model the longitudinal latent effect of pregabalin or usual care ( UC ) therapies on changes in sleep in out patients with GAD under routine clinical practice . Methods Male and female GAD out patients , aged 18 years or above , from a 6-month prospect i ve noninterventional trial were analyzed . Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms ( assessed with Hamilton Anxiety Scale ) and sleep disturbances ( assessed with Medical Outcomes Study -Sleep Scale [ MOS-S ] ) were estimated by a conditional latent curve model applying structural equation modeling . Results A total of 1,546 pregabalin-naïve patients were analyzed , 984 receiving pregabalin and 562 UC . Both symptoms of anxiety and sleep disturbances were significantly improved in both groups , with higher mean ( 95 % confidence interval ) score reductions in subjects receiving pregabalin : −15.9 ( −15.2 ; −16.6 ) vs −14.5 ( −13.5 ; −15.5 ) , P=0.027 , in Hamilton Anxiety Scale ; and −29.7 ( −28.1 ; −31.3 ) vs −24.0 ( −21.6 ; −26.4 ) , P<0.001 , in MOS-S. The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant ( γ = −3.99 , P<0.001 ) , after discounting the effect on reduction in anxiety symptoms . A mediation model showed that 70 % of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement . Conclusion A substantial proportion of the incremental improvements in anxiety-related sleep disturbances with pregabalin vs UC were explained by its direct effect , not mediated by improvements in anxiety symptoms Background : Remission has become one of the leading outcome criteria in clinical trials . Data collected by this research group assessed the rate of remission after 6 months of treatment of generalized anxiety disorder ( GAD ) with venlafaxine XR , to search for predictors of remission and to define how early on in treatment later remission can be predicted . Method : Two hundred sixty-eight patients with a GAD diagnosis enrolled into an open-label 6-month-treatment trial with venlafaxine XR ( 75 - 225 mg/day ) . Remission was defined by a Hamilton anxiety scale total score ≤7 . Logistic regression approaches were used to find out how early on in treatment later remission could be predicted , as well as to determine predictors of remission . In addition , adverse events were also followed over time . Results : While the total enrolled patient sample ( n = 268 ) had a remission rate of 53 % , 6-month completers ( n = 159 ) had a remission rate of 79 % . The only statistically significant predictor of remission , independent of baseline anxiety and depression levels , was a low Eysenck neuroticism score . The remission status outcome could best be predicted after 8 weeks of treatment when a CGI-I score of 1 or 2 predicted later remission with 78 % accuracy and later nonremission with 91 % accuracy . The incidence of adverse events decreased over the 6-month period , with sexual adverse events decreasing the least . Conclusion : The only significant predictor of remission was a OUTPUT:

Our review confirms the usefulness of long-term pharmacological treatments for PD and GAD and suggests that they can provide further improvement over that obtained during short-term therapy . Paroxetine , escitalopram , and clonazepam can be effective for long-term treatment of PD . Pregabalin and quetiapine can be effective for long-term treatment of GAD , while preliminary suggestions emerged for agomelatine and vortioxetine . We did not find any evidence for determining the optimal length and /or dosage of medications to minimize the relapse risk .

MS2_dynamic_1_shot9

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVES To assess the optimal stroke prevention treatment for patients with atrial fibrillation ( AF ) and a low-medium risk ( < or = 4 % ) of stroke . DESIGN A total of 668 patients with persistent or permanent AF , without an indication for full dose and with adequate rate control on sotalol , were r and omized to warfarin 1.25 mg + aspirin 75 mg daily ( W/A , 334 patients ) or no anticoagulation ( C , 334 patients ) . The mean follow-up period was 33 months . The protocol intended to verify a 37 % relative risk reduction provided a 4 % stroke incidence in the C group . RESULTS The stroke incidence was less in the W/A group , although the reduction was not statistically significant ( W/A 9.6 % versus C 12.3 % ) . Four haemorrhagic strokes were identified , two in each group . Secondary end-points were transient ischaemic attacks ( TIA ) ( W/A 3.3 % versus C 4.5 % ) , all cause mortality ( W/A 9.3 % versus C 10.8 % ) , cardiovascular morbidity ( W/A 17.7 % versus C 22.2 % ) and the combination of stroke + TIA ( W/A 11.7 % versus C 16.5 % ) . Bleedings were documented in 19 versus four patients ( W/A 5.7 % versus C 1.2 % ) ( P = 0.003 ) , although none fatal . Sinus rhythm ( SR ) was recorded occasionally in 68 patients ( W/A 9.6 % versus C 10.8 % ) . The stroke incidence tended to be higher in those with SR than without , 16.2 % versus 10.4 % . CONCLUSIONS Our results were inconclusive , but consistent with a small beneficial effect of W/A for reduction of stroke and major vascular events in AF patients at moderate risk . The low-dose regiment produced , however , a significantly increased risk of bleedings . Documented SR occasionally recorded may represent a sub population that warrants full dose warfarin BACKGROUND AND PURPOSE Nonvalvular atrial fibrillation ( AF ) is a strong , independent risk factor for stroke , but the absolute rate of stroke varies widely among AF patients , importantly influencing the potential benefit of antithrombotic prophylaxis . We explore factors associated with ischemic stroke in AF patients taking aspirin . METHODS We performed multivariate logistic regression analysis of 2012 participants given aspirin alone or in combination with low , inefficacious doses of warfarin in the Stroke Prevention in Atrial Fibrillation I-III trials followed for a mean of 2.0 years , during which 130 ischemic strokes were observed . RESULTS Age ( relative risk [RR]=1.8 per decade , P<0.001 ) , female sex ( RR=1.6 , P=0.01 ) , history of hypertension ( RR=2.0 , P<0.001 ) , systolic blood pressure > 160 mm Hg ( RR=2.3 , P<0.001 ) , and prior stroke or transient ischemic attack ( RR=2.9 , P<0.001 ) were independently associated with increased stroke risk . Regular consumption of > /=14 alcohol-containing drinks per week was associated with reduced stroke risk ( adjusted RR=0.4 , P=0.04 ) . Among SPAF III participants , estrogen hormone replacement therapy was associated with a higher risk of ischemic stroke ( adjusted RR=3.2 , P=0.007 ) . With the use of these variables , a risk stratification scheme for primary prevention separated participants into those with high ( 7.1%/y , 22 % of the cohort ) , moderate ( 2.6%/y , 37 % of the cohort ) , and low ( 0.9%/y , 41 % of the cohort ) rates of stroke . Ischemic strokes in low-risk participants were less often disabling ( P<0.001 ) . CONCLUSIONS Patients with AF who have high and low rates of stroke during treatment with aspirin can be identified . However , validation of our risk stratification scheme is necessary before it can be applied with confidence to clinical management . Postmenopausal estrogen replacement therapy and moderate alcohol consumption may additionally modify the risk of stroke in AF , but these findings require confirmation Background Atrial fibrillation in the absence of rheumatic valvular disease is associated with a fivefold to sevenfold increased risk of ischemic stroke . Methods and Main Results . The Stroke Prevention in Atrial Fibrillation Study , a multicenter , r and omized trial , compared 325 mg/day aspirin ( double-blind ) or warfarin with placebo for prevention of ischemic stroke and systemic embolism ( primary events ) , and included 1,330 in patients and out patients with constant or intermittent atrial fibrillation . During a mean follow-up of 1.3 years , the rate of primary events in patients assigned to placebo was 6.3 % per year and was reduced by 42 % in those assigned to aspirin ( 3.6 % per year , p = 0.02 ; 95 % confidence interval , 9–63 % ) . In the subgroup of warfarin-eligible patients ( most less than 76 years old ) , warfarin dose-adjusted to prolong prothrombin time to 1.3-fold to 1.8-fold that of control reduced the risk of primary events by 67 % ( warfarin versus placebo , 2.3 % versus 7.4 % per year , p = 0.01 ; 95 % confidence interval , 27–85 % ) . Primary events or death were reduced 58 % ( p = 0.01 ) by warfarin and 32 % ( p = 0.02 ) by aspirin . The risk of OUTPUT: The observed rates of intracranial and extracranial hemorrhage were not significantly increased by OAC therapy , but the confidence intervals were wide . Treatment with adjusted-dose warfarin to achieved INRs of 2 to 3 reduces stroke , disabling or fatal stroke , and death for patients with non-valvular AF . The benefits were not substantially offset by increased bleeding among these participants in r and omized clinical trials . INPUT: Aim Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation ( AF ) . We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation . Methods and results Patients r and omized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) trial ( n = 14 264 ) were grouped by baseline AF category : paroxysmal or persistent . Multivariable adjustment was performed to compare thrombo-embolic events , bleeding , and death between groups , in high-risk subgroups , and across treatment assignment ( rivaroxaban or warfarin ) . Of 14 062 patients , 11 548 ( 82 % ) had persistent AF and 2514 ( 18 % ) had paroxysmal AF . Patients with persistent AF were marginally older ( 73 vs. 72 , P = 0.03 ) , less likely female ( 39 vs. 45 % , P < 0.0001 ) , and more likely to have previously used vitamin K antagonists ( 64 vs. 56 % , P < 0.0001 ) compared with patients with paroxysmal AF . In patients r and omized to warfarin , time in therapeutic range was similar ( 58 vs. 57 % , P = 0.94 ) . Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( 2.18 vs. 1.73 events per 100-patient-years , P = 0.048 ) and all-cause mortality ( 4.78 vs. 3.52 , P = 0.006 ) . Rates of major bleeding were similar ( 3.55 vs. 3.31 , P = 0.77 ) . Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = 0.6 ) . Conclusion In patients with AF at moderate-to-high risk of stroke receiving anticoagulation , those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF Background and Purpose — We sought to investigate the apparently high risk of early death after an ischemic stroke among patients with atrial fibrillation ( AF ) , identify the main factors associated with early death , and assess the effect of treatment with different doses of subcutaneous unfractionated heparin ( UFH ) given within 48 hours . Methods — We studied the occurrence of major clinical events within 14 days among 18 451 patients from the International Stroke Trial , first for all treatment groups combined . Then , among patients with AF , we examined the effects of treatment with subcutaneous UFH started within 48 hours and continued until 14 days after stroke onset . Results — A total of 3169 patients ( 17 % ) had AF . Seven hundred eighty-four patients were allocated to UFH 12 500 IU SC BID , 773 to UFH 5000 IU SC BID , and 1612 to no heparin . Within each of these groups , half of the patients were r and omly assigned to aspirin 300 mg once daily . Compared with patients without AF , patients with AF were more likely to be female ( 56 % versus 45 % ) , to be old ( mean age , 78 versus 71 years ) , to have an infa rct on prer and omization CT ( 57 % versus 47 % ) , and to have impaired consciousness ( 37 % versus 20 % ) . The initial ischemic stroke type was more often a large-artery infa rct ( 36 % versus 21 % ) . A lacunar stroke syndrome was less common ( 13 % versus 26 % ) . Death within 14 days was more common in patients with AF ( 17 % versus 8 % ) and more often attributed to neurological damage from the initial stroke ( 10 % versus 4 % ) . The frequency of recurrent ischemic or undefined stroke was not significantly different ( 3.9 % versus 3.3 % ) . The proportion of AF patients with further events within 14 days allocated to UFH 12 500 IU ( n=784 ) , UFH 5000 IU ( n=773 ) , and to no-heparin ( n=1612 ) groups were as follows : ischemic stroke , 2.3 % , 3.4 % , 4.9 % ( P = 0.001 ) ; hemorrhagic stroke , 2.8 % , 1.3 % , 0.4 % ( P < 0.0001 ) ; and any stroke or death , 18.8 % , 19.4 % and 20.7 % ( P = 0.3 ) , respectively . No effect of heparin on the proportion of patients dead or dependent at 6 months was apparent . Conclusions — Acute ischemic stroke patients with AF have a higher risk of early death , which can be explained by older age and larger infa rcts but not by a higher risk of early recurrent ischemic stroke , although slightly more patients with AF died from a fatal recurrent stroke of ischemic or unknown type ( 1.3 % versus 0.9 % ) . In patients with AF the absolute risk of early recurrent stroke is low , and there is no net advantage to treatment with heparin . These data do not support the widespread use of intensive heparin regimens in the acute phase of ischemic stroke associated with AF BACKGROUND Few epidemiologic cohort studies have evaluated atrial flutter ( flutter ) as an arrhythmia distinct from atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to examine the clinical correlates of flutter and its associated outcomes to distinguish them from those associated with AF in OUTPUT:

These results showed that AF is an independent risk factor for MI , CV death , and CV events

MS2_dynamic_1_shot10

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Cholera is endemic in Bangladesh with epidemics occurring each year . The decision to use a cheap oral killed whole-cell cholera vaccine to control the disease depends on the feasibility and effectiveness of vaccination when delivered in a public health setting . We therefore assessed the feasibility and protective effect of delivering such a vaccine through routine government services in urban Bangladesh and evaluated the benefit of adding behavioural interventions to encourage safe drinking water and h and washing to vaccination in this setting . METHODS We did this cluster-r and omised open-label trial in Dhaka , Bangladesh . We r and omly assigned 90 clusters ( 1:1:1 ) to vaccination only , vaccination and behavioural change , or no intervention . The primary outcome was overall protective effectiveness , assessed as the risk of severely dehydrating cholera during 2 years after vaccination for all individuals present at time of the second dose . This study is registered with Clinical Trials.gov , number NCT01339845 . FINDINGS Of 268,896 people present at baseline , we analysed 267,270 : 94,675 assigned to vaccination only , 92,539 assigned to vaccination and behavioural change , and 80,056 assigned to non-intervention . Vaccine coverage was 65 % in the vaccination only group and 66 % in the vaccination and behavioural change group . Overall protective effectiveness was 37 % ( 95 % CI lower bound 18 % ; p=0·002 ) in the vaccination group and 45 % ( 95 % CI lower bound 24 % ; p=0·001 ) in the vaccination and behavioural change group . We recorded no vaccine-related serious adverse events . INTERPRETATION Our findings provide the first indication of the effect of delivering an oral killed whole-cell cholera vaccine to poor urban population s with endemic cholera using routine government services and will help policy makers to formulate vaccination strategies to reduce the burden of severely dehydrating cholera in such population s. FUNDING Bill & Melinda Gates Foundation This paper analyzes a r and omized experiment that uses novel strategies to promote h and washing with soap at critical points in time in Peru . It evaluates a large-scale comprehensive initiative that involved both community and school activities in addition to communication campaigns . The analysis indicates that the initiative was successful in reaching the target audience and in increasing the treated population 's knowledge about appropriate h and washing behavior . These improvements translated into higher self-reported and observed h and washing with soap at critical junctures . However , no significant improvements in the health of children under the age of 5 years were observed . Copyright © 2015 John Wiley & Sons , Summary Background Diarrhoea and growth faltering in early childhood are associated with subsequent adverse outcomes . We aim ed to assess whether water quality , sanitation , and h and washing interventions alone or combined with nutrition interventions reduced diarrhoea or growth faltering . Methods The WASH Benefits Bangladesh cluster-r and omised trial enrolled pregnant women from villages in rural Bangladesh and evaluated outcomes at 1-year and 2-years ' follow-up . Pregnant women in geographically adjacent clusters were block-r and omised to one of seven clusters : chlorinated drinking water ( water ) ; up grade d sanitation ( sanitation ) ; promotion of h and washing with soap ( h and washing ) ; combined water , sanitation , and h and washing ; counselling on appropriate child nutrition plus lipid-based nutrient supplements ( nutrition ) ; combined water , sanitation , h and washing , and nutrition ; and control ( data collection only ) . Primary outcomes were caregiver-reported diarrhoea in the past 7 days among children who were in utero or younger than 3 years at enrolment and length-for-age Z score among children born to enrolled pregnant women . Masking was not possible for data collection , but analyses were masked . Analysis was by intention to treat . This trial is registered at Clinical Trials.gov , number NCC01590095 . Findings Between May 31 , 2012 , and July 7 , 2013 , 5551 pregnant women in 720 clusters were r and omly allocated to one of seven groups . 1382 women were assigned to the control group ; 698 to water ; 696 to sanitation ; 688 to h and washing ; 702 to water , sanitation , and h and washing ; 699 to nutrition ; and 686 to water , sanitation , h and washing , and nutrition . 331 ( 6 % ) women were lost to follow-up . Data on diarrhoea at year 1 or year 2 ( combined ) were available for 14 425 children ( 7331 in year 1 , 7094 in year 2 ) and data on length-for-age Z score in year 2 were available for 4584 children ( 92 % of living children were measured at year 2 ) . All interventions had high adherence . Compared with a prevalence of 5·7 % ( 200 of 3517 child weeks ) in the control group , 7-day diarrhoea prevalence was lower among index children and children under 3 years at enrolment who received sanitation ( 61 [ 3·5 % ] of 1760 ; prevalence ratio 0·61 , 95 % CI 0·46–0·81 ) , h and washing ( 62 [ 3·5 % ] of 1795 ; 0·60 , 0·45–0·80 ) , combined water , sanitation , and h and washing ( 74 [ 3·9 % ] of 1902 ; 0·69 , 0·53–0·90 ) , nutrition ( OUTPUT: Conclusions Many people lack a design ated h and washing facility , but even among those with access , HWWS is poorly practised . People with access to design ated h and washing facilities are about twice as likely to wash their h and s with soap after potential faecal contact as people who lack a facility . INPUT: Vaccination of one person may prevent the infection of another either because the vaccine prevents the first from being infected and from infecting the second , or because , even if the first person is infected , the vaccine may render the infection less infectious . We might refer to the first of these mechanisms as a contagion effect and the second as an infectiousness effect . In the simple setting of a r and omized vaccine trial with households of size two , we use counterfactual theory under interference to provide formal definitions of a contagion effect and an unconditional infectiousness effect . Using ideas analogous to mediation analysis , we show that the indirect effect ( the effect of one person 's vaccine on another 's outcome ) can be decomposed into a contagion effect and an unconditional infectiousness effect on the risk difference , risk ratio , odds ratio , and vaccine efficacy scales . We provide identification assumptions for such contagion and unconditional infectiousness effects and describe a simple statistical technique to estimate these effects when they are identified . We also give a sensitivity analysis technique to assess how inferences would change under violations of the identification assumptions . The concepts and results of this paper are illustrated with hypothetical vaccine trial data BACKGROUND We evaluated the herd protection conferred by an oral cholera vaccine using 2 approaches : cluster design and geographic information system ( GIS ) design . METHODS Residents living in 3933 dwellings ( clusters ) in Kolkata , India , were cluster-r and omized to receive either cholera vaccine or oral placebo . Nonpregnant residents aged≥1 year were invited to participate in the trial . Only the first episode of cholera detected for a subject between 14 and 1095 days after a second dose was considered . In the cluster design , indirect protection was assessed by comparing the incidence of cholera among non participants in vaccine clusters vs those in placebo clusters . In the GIS analysis , herd protection was assessed by evaluating association between vaccine coverage among the population residing within 250 m of the household and the occurrence of cholera in that population . RESULTS Among 107 347 eligible residents , 66 990 received 2 doses of either cholera vaccine or placebo . In the cluster design , the 3-year data showed significant total protection ( 66 % protection , 95 % confidence interval [ CI ] , 50%-78 % , P<.01 ) but no evidence of indirect protection . With the GIS approach , the risk of cholera among placebo recipients was inversely related to neighborhood-level vaccine coverage , and the trend was highly significant ( P<.01 ) . This relationship held in multivariable models that also controlled for potentially confounding demographic variables ( hazard ratio , 0.94 [ 95 % CI , .90-.98 ] ; P<.01 ) . CONCLUSIONS Indirect protection was evident in analyses using the GIS approach but not the cluster design approach , likely owing to considerable transmission of cholera between clusters , which would vitiate herd protection in the cluster analyses . CLINICAL TRIALS REGISTRATION NCT00289224 Spatial analyses of the effect of insecticide (permethrin)-treated bed nets ( ITNs ) on nearby households both with and without ITNs was performed in the context of a large-scale , group-r and omized , controlled mortality trial in Asembo , western Kenya . Results illustrate a protective effect of ITNs on compounds lacking ITNs located within 300 meters of compounds with ITNs for child mortality , moderate anemia , high-density parasitemia , and hemoglobin levels . This community effect on nearby compounds without nets is approximately as strong as the effect observed within villages with ITNs . This implies that in areas with intense malaria transmission with high ITN coverage , the primary effect of insecticide-treated nets is via area-wide effects on the mosquito population and not , as commonly supposed , by simple imposition of a physical barrier protecting individuals from biting . The strength of the community effect depended upon the proportion of nearby compounds with treated nets . To maximize their public health impact , high coverage with treated nets is essential Objective To assess the efficacy of modest non-financial incentives on immunisation rates in children aged 1 - 3 and to compare it with the effect of only improving the reliability of the supply of services . Design Clustered r and omised controlled study . Setting Rural Rajasthan , India . Participants 1640 children aged 1 - 3 at end point . Interventions 134 villages were r and omised to one of three groups : a once monthly reliable immunisation camp ( intervention A ; 379 children from 30 villages ) ; a once monthly reliable immunisation camp with small incentives ( raw lentils and metal plates for completed immunisation ; intervention B ; 382 children from 30 villages ) , or control ( no intervention , 860 children in 74 villages ) . Surveys were undertaken in r and omly selected households at baseline and about 18 months after the interventions started ( end point ) . Main outcome measures Proportion of children aged 1 - 3 at the end point who were partially or fully immunised . Results Among children aged 1 - 3 in the end point survey , rates of full immunisation were 39 % ( 148/382 , 95 % confidence interval 30 % to 47 % ) for intervention B villages ( reliable immunisation with incentives ) , 18 % ( 68/379 , 11 % to 23 % ) for intervention A villages ( reliable immunisation without incentives ) , and 6 % ( 50/860 , 3 % to 9 % ) for control villages . The relative risk of complete immunisation for intervention B versus control was 6.7 ( 4.5 to 8.8 ) and for intervention B versus intervention A was 2.2 ( 1.5 to 2.8 ) . Children in areas neighbouring intervention B villages were also more likely to be fully immun OUTPUT:

We identified three primary mechanisms of spillovers : reduced disease transmission , social proximity and substitution of re sources within households . We found the strongest evidence for spillovers through reduced disease transmission , particularly vaccines and mass drug administration . In general , the proportion of a population receiving an intervention was associated with improved health . We found evidence of publication bias for certain spillover estimates but not for total or direct effects . Conclusions We found the strongest evidence for spillovers from vaccines and mass drug administration to control infectious disease . There was little high quality evidence of spillovers for other interventions

MS2_dynamic_1_shot11

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Type 2 diabetes mellitus is a worldwide challenge . Practice guidelines promote structured self-monitoring of blood glucose ( SMBG ) for informing health care providers about glycemic control and providing patient feedback to increase knowledge , self-efficacy , and behavior change . Paired glucose testing — pairs of glucose results obtained before and after a meal or physical activity — is a method of structured SMBG . However , frequent access to glucose data to interpret values and recommend actions is challenging . A complete feedback loop— data collection and interpretation combined with feedback to modify treatment — has been associated with improved outcomes , yet there remains limited integration of SMBG feedback in diabetes management . Incorporating telehealth remote monitoring and asynchronous electronic health record ( EHR ) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management — employ the complete feedback loop to improve outcomes . Objective The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes . The primary aim was change in glycated hemoglobin (A1c)—a measure of overall glucose management — between groups after 6 months . The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities ( SDSCA ) , Diabetes Empowerment Scale , and Diabetes Knowledge Test . Methods A 2-group r and omized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits . Participants were aged 30 - 70 years , not using insulin with A1c levels between 7.5 % and 10.9 % ( 58 - 96 mmol/mol ) . The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants , analyze actionable glucose data , and provide feedback . Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly . CDEs called participants monthly to discuss paired glucose testing trends and treatment changes . Separate mixed-effects models were used to analyze data . Results Participants ( N=90 ) were primarily white ( 64 % , 56/87 ) , mean age 58 ( SD 11 ) years , mean body mass index 34.1 ( SD 6.7 ) kg/m2 , with diabetes for mean 8.2 ( SD 5.4 ) years , and a mean A1c of 8.3 % ( SD 1.1 ; 67 mmol/mol ) . Both groups lowered A1c with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months ( SE 0.08 , t159=–2.87 , P=.005 ) . Change in medication ( SE 0.21 , t157=–3.37 , P=.009 ) was significantly associated with lower A1c level . The treatment group significantly improved on the SDSCA subscales carbohydrate spacing ( P=.04 ) , monitoring glucose ( P=.001 ) , and foot care ( P=.02 ) . Conclusions An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A1c levels compared to usual care . Trial Registration Clinical trials.gov NCT01715649 ; https://www . clinical trials.gov/ct2/show/NCT01715649 ( Archived by WebCite at http://www.webcitation.org/6ZinLl8D0 ) AIM This paper is a report of a study conducted to assess the effectiveness of an educational intervention for people with type 2 diabetes based on self-completed instruments to identify particular areas of self-care needs . BACKGROUND Diabetes is a dem and ing disease which requires self-care . Instruments that identify self-care needs or factors affecting self-care can be helpful to detect level of self-care , distress or knowledge among individuals with diabetes . METHODS Participants were r and omized into intervention ( n = 28 ) or control groups ( n = 25 ) . Both groups answered five vali date d instruments three times , at baseline and after 3 and 6 months , and biological measurements were conducted simultaneously . The intervention was based on an empowerment approach . The study started in November 2005 and lasted until March 2007 . FINDINGS There was no statistically significant difference between groups in level of glycated haemoglobin postintervention as it reduced statistically significantly in both groups between baseline and 3 months but increased again after 6 months . There was no statistically significant difference between groups in body mass index reduction ; the intervention group achieved a statistically significant body mass index reduction but this was unchanged in the control group . No statistically significant differences between groups were found in scores for empowerment , well-being and distress . There was a statistically significant difference between groups in knowledge postintervention . CONCLUSION Use of instruments to identify self-care needs can enable patient-tailored care as it allows direct focusing on issues that are challenging and of relevance for each individual . It seems to be feasible to use the telephone to conduct an empowering educational intervention after one meeting Purpose The purpose of this pilot study was to evaluate the effects of a culturally sensitive , empowerment-based diabetes self-management education program for Spanish-speaking Hispanic/Latinos . Methods A prospect i ve quasi-experimental repeated measures design tested the effectiveness of the ¡ Si , Yo Puedo Controlar Mi Diabetes ! diabetes self-management education program . In sum , 144 persons residing in 2 Texas counties at the Texas-Mexico border ( Starr and Hidalgo ) served as participants . Two groups were formed , an intervention and a control ( wait list ) . Clinical ( A1C ) , cognitive , attitudinal , behavioral , and cultural assessment s were OUTPUT: However , after meta- analysis , no statistically significant improvement was found for HbA1c . CONCLUSION This systematic review showed that individual strategies for DM empowerment were not effective in reducing HbA1c , despite contributing to improvements in psychosocial parameters . INPUT: Sustained improvement in blood glucose control is the only treatment outcome which will reduce or eliminate the long term complications of diabetes mellitus . We have design ed and evaluated an electronic information system which facilitates this task . The system is voice-interactive , physician directed and affords , to remote patients , 24 h access via touch-tone telephone . Accordingly , patients access the system each day to report self-measured blood glucose levels or hypoglycaemic symptoms together with dietary changes , planned exercise , stress , illness or other lifestyle events . In turn they receive immediate advice with respect to medication dosing changes , and other pertinent feedback . Preliminary system beta-testing for safety and efficacy was performed for one year in an open study of 204 patients derived from two independent , health-care environments . Among the two testing centres , over 60,000 telephone cells were received by the computer systems during the start-up year . Safety and efficacy expectations were met . In addition , prevalence of diabetes related crises ( hyperglycaemia or hypoglycaemia ) fell approximately 3-fold . Glycated haemoglobin fell significantly ( 1.0 - 1.3 % ) in patients actively using the system . In control groups of patients not actively using the system , there were no improvements in metabolic control while body weights were stable in all groups . The new system was safe and effective in our h and s and empowered our health professionals to provide improved diabetes care Background Type 2 diabetes mellitus is a worldwide challenge . Practice guidelines promote structured self-monitoring of blood glucose ( SMBG ) for informing health care providers about glycemic control and providing patient feedback to increase knowledge , self-efficacy , and behavior change . Paired glucose testing — pairs of glucose results obtained before and after a meal or physical activity — is a method of structured SMBG . However , frequent access to glucose data to interpret values and recommend actions is challenging . A complete feedback loop— data collection and interpretation combined with feedback to modify treatment — has been associated with improved outcomes , yet there remains limited integration of SMBG feedback in diabetes management . Incorporating telehealth remote monitoring and asynchronous electronic health record ( EHR ) feedback from certified diabetes educators (CDEs)—specialists in glucose pattern management — employ the complete feedback loop to improve outcomes . Objective The purpose of this study was to evaluate a telehealth remote monitoring intervention using paired glucose testing and asynchronous data analysis in adults with type 2 diabetes . The primary aim was change in glycated hemoglobin (A1c)—a measure of overall glucose management — between groups after 6 months . The secondary aims were change in self-reported Summary of Diabetes Self-Care Activities ( SDSCA ) , Diabetes Empowerment Scale , and Diabetes Knowledge Test . Methods A 2-group r and omized clinical trial was conducted comparing usual care to telehealth remote monitoring with paired glucose testing and asynchronous virtual visits . Participants were aged 30 - 70 years , not using insulin with A1c levels between 7.5 % and 10.9 % ( 58 - 96 mmol/mol ) . The telehealth remote monitoring tablet computer transmitted glucose data and facilitated a complete feedback loop to educate participants , analyze actionable glucose data , and provide feedback . Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly . CDEs called participants monthly to discuss paired glucose testing trends and treatment changes . Separate mixed-effects models were used to analyze data . Results Participants ( N=90 ) were primarily white ( 64 % , 56/87 ) , mean age 58 ( SD 11 ) years , mean body mass index 34.1 ( SD 6.7 ) kg/m2 , with diabetes for mean 8.2 ( SD 5.4 ) years , and a mean A1c of 8.3 % ( SD 1.1 ; 67 mmol/mol ) . Both groups lowered A1c with an estimated average decrease of 0.70 percentage points in usual care group and 1.11 percentage points in the treatment group with a significant difference of 0.41 percentage points at 6 months ( SE 0.08 , t159=–2.87 , P=.005 ) . Change in medication ( SE 0.21 , t157=–3.37 , P=.009 ) was significantly associated with lower A1c level . The treatment group significantly improved on the SDSCA subscales carbohydrate spacing ( P=.04 ) , monitoring glucose ( P=.001 ) , and foot care ( P=.02 ) . Conclusions An eHealth model incorporating a complete feedback loop with telehealth remote monitoring and paired glucose testing with asynchronous data analysis significantly improved A1c levels compared to usual care . Trial Registration Clinical trials.gov NCT01715649 ; https://www . clinical trials.gov/ct2/show/NCT01715649 ( Archived by WebCite at http://www.webcitation.org/6ZinLl8D0 ) OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS OUTPUT:

In addition , the more CCM-incorporated the information technology-based interventions were , the more improvements there were in HbA1c levels . CONCLUSIONS Information technology strategies combined with the other elements of chronic care models are associated with improved glycemic control in people with diabetes . No clinical ly relevant impact was observed on low-density lipoprotein levels and blood pressure , but there was evidence that the cost of care was lower

MS2_dynamic_1_shot12

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To better estimate how frequently patients with low serum cobalamin ( Cbl ) levels in current clinical practice are truly deficient in Cbl and to determine the incidence of atypical or nonclassic presentations of Cbl deficiency , we prospect ively studied 300 unselected consecutive patients with serum Cbl concentrations less than 200 pg/mL seen at two medical centers over a 2-year period . Baseline hematologic , neuropsychiatric , and biochemical measurements were obtained , followed by a course of parenteral Cbl therapy and re assessment . A response to Cbl therapy was defined as one or more of the following : ( 1 ) an increase in hematocrit of 0.05 or more ; ( 2 ) a decrease in mean cell volume of 5 fL or more ; ( 3 ) a clearing of hypersegmented neutrophilis and macroovalocytes from the peripheral blood smear ; and ( 4 ) an unequivocal and prompt improvement of neuropsychiatric abnormalities . Of the 300 patients with serum Cbl levels less than 200 pg/mL , 86 had one or more responses to Cbl therapy and 59 had no response . In 155 , insufficient data was available . In the Cbl-responsive patients , normal values were found for the following tests : hematocrit , 44 % ; mean cell volume less than or equal to 100 fL , 36 % ; white blood cell count , 84 % ; platelet count , 79 % ; serum lactic dehydrogenase , 43 % ; and serum bilirubin , 83 % . Peripheral blood smears were nondiagnostic in 6 % when review ed by the investigators , but 33 % as reported by routine laboratories . Serum Cbl levels in the 100 to 199 pg/mL range were present in 38 % . Neuropsychiatric abnormalities were noted in 28 % , often in the absence of anemia , macrocytosis , or both . Serum levels of methylmalonic acid and /or total homocysteine were elevated greater than 3 SDs above the mean for normal subjects in 94 % of the Cbl-responsive patients . We conclude that Cbl deficiency should be considered and investigated in patients with unexplained hematologic or neuropsychiatric abnormalities of the kind seen in Cbl deficiency , even if anemia , an elevated mean cell volume , a marked depression of the serum Cbl , or other classic hematologic or biochemical abnormalities are lacking . Levels of serum methylmalonic acid and total homocysteine are useful as ancillary diagnostic tests in the diagnostis of Cbl deficiency BACKGROUND A self-rating inventory has been developed to measure DSM-IV and ICD-10 diagnoses of major ( moderate to severe ) depression by the patients ' self-reported symptoms . This Major Depression Inventory ( MDI ) can be scored both according to the DSM-IV and the ICD-10 algorithms for depressive symptomatology and according to severity scales by the simple total sum of the items . METHODS The Schedule for Clinical Assessment in Neuropsychiatry ( SCAN ) was used as index of validity for the clinician 's DSM-IV and ICD-10 diagnosis of major ( moderate to severe ) depression . The sensitivity and specificity of MDI was assessed in a sample of 43 subjects covering a spectrum of depressive symptoms . RESULTS The sensitivity of the MDI algorithms for major depression varied between 0.86 and 0.92 . The specificity varied between 0.82 and 0.86 . When using the total score of MDI the optimal cut-off score was estimated 26 and the total score was shown to be a sufficient statistic . LIMITATIONS The sample of subjects was limited . Patients with psychotic depression were not included . CONCLUSION The MDI was found to have a sensitivity and specificity which is acceptable . The question naire is brief and can be scored diagnostically by the DSM-IV and ICD-10 algorithms as well as by its simple total score OBJECTIVE To measure the prevalence of cobalamin ( vitamin B12 ) deficiency in geriatric out patients as documented by both low serum cobalamin levels and elevations of serum methylmalonic acid and homocysteine and to determine the response to cobalamin treatment . DESIGN Prospect i ve study screening elderly subjects for cobalamin deficiency using radiodilution cobalamin assays as well as stable isotope dilution gas chromatography-mass spectrometry methylmalonic acid and homocysteine assays . In patients with serum cobalamin levels < or = 300 pg/mL , the response to cobalamin treatment in the group with levels of methylmalonic acid and /or homocysteine > 3 st and ard deviations ( SD ) above the mean for normals was compared with that of those without such elevations . SETTING Outpatient geriatric clinics at the VA Medical Center and University Health Sciences Center , Denver , CO . PATIENTS One-hundred and fifty-two consecutive out patients , ages 65 to 99 , were screened . Twenty-nine subjects with serum cobalamin levels < or = 300 pg/mL were prospect ively evaluated and treated with cobalamin . MAIN OUTCOME MEASURES Cobalamin , methylmalonic acid , homocysteine , complete blood counts , neurologic examination , and neuropsychological testing . RESULTS The prevalence of cobalamin deficiency as defined by a serum cobalamin level < or = 300 pg/mL and levels of serum methylmalonic acid and /or homocysteine elevated to > 3 SD was 14.5 % of the screened out patients . A similar proportion of patients with low normal serum cobalamin levels ( between 201 and 300 pg/mL ) demonstrated elevated metabolites > OUTPUT: MAIN RESULTS From the two included studies ( Seal 2002 ; Fourniere 1997 ) of people with dementia and low serum vitamin B12 levels , there was no statistically significant evidence of treatment effect , vitamin B12 supplementation compared with placebo , on cognitive function . INPUT: BACKGROUND The st and ard treatment for cobalamin ( vitamin B(12 ) ) deficiency involves regular intramuscular cobalamin injection . It has been suggested that oral cobalamin therapy may be effective for treating patients who have food-cobalamin malabsorption . SUBJECTS AND METHODS We prospect ively studied 10 patients with cobalamin deficiency and well-established food-cobalamin malabsorption who received 3000 microg or 5000 microg of oral crystalline cyanocobalamin once a week for at least 3 months . Complete blood counts and serum cobalamin , homocysteine , and folate levels were determined at baseline and after 3 months of treatment . Patients were reexamined after 6 months . RESULTS After 3 months of treatment , all patients had increased hemoglobin levels ( mean increase , 1.9 g/dL ; 95 % confidence interval : 0.9 to 3.9 g/dL;P < 0.01 compared with baseline ) and decreased erythrocyte cell volume ( mean decrease , 7.8 fL ; 95 % confidence interval : 0.9 to 16.5 fL;P<0.001 ) . However , 2 patients had only minor , if any , responses . Serum cobalamin levels were increased in all 8 patients in whom it was measured . CONCLUSION Our findings suggest that moderate doses of crystalline cyanocobalamin given orally may be an effective treatment for food-cobalamin malabsorption AIMS To investigate the nasal absorption of hydroxocobalamin in 10 healthy elderly adults . METHODS In a cross-over study , blood sample s were collected before administration of the drug and after 10 , 20 , 30 , 40 , 60 , 120 , 180 and 240 min . The plasma cobalamin concentration was determined by competitive radioisotope binding technique . RESULTS The maximal plasma cobalamin concentration ( Cmax ) after nasal administration of 750 microg hydroxocobalamin was 1900 + /- 900 pmol l(-1 ) ( mean + /- s.d . ) . The maximal plasma cobalamin concentration was reached in 35 + /- 13 min ( t[max ] ) . The Cmax after nasal administration of 1500 microg hydroxocobalamin was 3500 + /- 2500 pmol l(-1 ) with a t(max ) of 28 + /- 16 min . Both the AUC(0,240 min ) and AUC(0,00 ) increased significantly with an increase of the dose from 750 microg to 1500 microg ( P = 0.037 and P = 0.028 , respectively ) . The nasal spray was well tolerated . No signs of irritation or local sensitivity were noted . CONCLUSIONS The nasal absorption of hydroxocobalamin in healthy elderly adults is rapid , high and well tolerated Because cobalamin deficiency is routinely treated with parenteral cobalamin , we investigated the efficacy of oral therapy . We r and omly assigned 38 newly diagnosed cobalamin deficient patients to receive cyanocobalamin as either 1 mg intramuscularly on days 1 , 3 , 7 , 10 , 14 , 21 , 30 , 60 , and 90 or 2 mg orally on a daily basis for 120 days . Therapeutic effectiveness was evaluated by measuring hematologic and neurologic improvement and changes in serum levels of cobalamin ( normal , 200 to 900 pg/mL ) methylmalonic acid ( normal , 73 to 271 nmol/L ) , and homocysteine ( normal , 5.1 to 13.9 micromol/L ) . Five patients were subsequently found to have folate deficiency , which left 18 evaluable patients in the oral group and 15 in the parenteral group . Correction of hematologic and neurologic abnormalities was prompt and indistinguishable between the 2 groups . The mean pretreatment values for serum cobalamin , methylmalonic acid , and homocysteine were , respectively , 93 pg/mL , 3,850 nmol/L , and 37 . 2 micromol/L in the oral group and 95 pg/mL , 3,630 nmol/L , and 40.0 micromol/L in the parenteral therapy group . After 4 months of therapy , the respective mean values were 1,005 pg/mL , 169 nmol/L , and 10.6 micromol/L in the oral group and 325 pg/mL , 265 nmol/L , and 12.2 micromol/L in the parenteral group . The higher serum cobalamin and lower serum methylmalonic acid levels at 4 months posttreatment in the oral group versus the parenteral group were significant , with P < .0005 and P < .05 , respectively . In cobalamin deficiency , 2 mg of cyanocobalamin administered orally on a daily basis was as effective as 1 mg administered intramuscularly on a monthly basis and may be superior BACKGROUND Cobalamin ( vitamin B12 ) deficiency , the most common cause of megaloblastic anemia , is treated with intramuscular ( IM ) cobalamin . It has been suggested by some investigators that oral ( p.o . ) cobalamin treatment may be as effective in the treatment of this condition , with the advantages of ease of administration and lower cost . OBJECTIVE This study assessed the effects and cost of p.o . versus i.m . cobalamin treatment OUTPUT:

The efficacy was particularly highlighted when looking at the marked improvement in serum vitamin B12 levels and hematological parameters , for example hemoglobin level , mean erythrocyte cell volume and reticulocyte count . Oral cobalamin treatment avoids the discomfort , inconvenience and cost of monthly injections . TAKE HOME MESSAGE Our experience and the present analysis support the use of oral cobalamin therapy in clinical practice

MS2_dynamic_1_shot13

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias Objectives : Examining the effects of tracheal suctioning on cerebral hemodynamics of normotensive ventilated very low birth weight ( VLBW ) infants with normal cranial ultrasounds ; determining the factor(s ) influencing changes in mean cerebral blood flow velocity ( CBFv ) after suctioning . Methods : Seventy-three VLBW infants had continuous monitoring of mean arterial blood pressure ( MABP ) , PaCO2 , PaO2 and mean CBFv before , during , and after 202 suctioning sessions during the first week of life . Peak ( or nadir ) and relative changes of the four variables for 45 min after suctioning were calculated . Multiple linear regression was used to determine the factor(s ) influencing changes in mean CBFv after suctioning . Result : Birth weight was 928±244 g ; gestational age was 27.0±2.0 weeks . Mean CBFv increased to 31.0±26.4 % after suctioning and remained elevated for 25 min . PaCO2 was highly associated with mean CBFv ( P<0.001 ) , whereas MABP and PaO2 were not . Conclusion : We observed prolonged increases of mean CBFv following suctioning in ventilated VLBW infants that were previously unrecognized . This is concerning since disturbances of CBF may be associated with subsequent brain injury Abstract A numeric scoring system for the assessment of hypoxic ischaemic encephalopathy during the neonatal period was tested . The value of the score in predicting neurodevelopmental outcome at 1 y of age was assessed . Forty‐five infants who developed hypoxic ischaemic encephalopathy after birth were studied prospect ively . In addition to the hypoxic ischaemic encephalopathy score all but two infants had at least one cranial ultrasound examination . Thirty‐five infants were evaluated at 12 months of age by full neurological examination and the Griffiths Scales of Mental Development . Five infants were assessed at an earlier stage , four who died before 6 months of age and one infant who was hospitalized at the time of the 12 month assessment . Twenty‐three ( 58 % ) of the infants were normal and 17 ( 42 % ) were abnormal , 16 with cerebral palsy and one with developmental delay . The hypoxic ischaemic encephalopathy score was highly predictive for outcome . The best correlation with outcome was the peak score ; a peak score of 15 or higher had a positive predictive value of 92 % and a negative predictive value of 82 % for abnormal outcome , with a sensitivity and specificity of 71 % and 96 % , respectively . For the clinician working in areas where sophisticated technology is unavailable this scoring system will be useful for assessment of infants with hypoxic ischaemic encephalopathy and for prognosis of neurodevelopmental outcome The effect of oro-naso-pharyngeal suction at birth on pulmonary mechanics is described in a r and om assigned controlled study of 40 normal term vaginally born infants . Twenty cases had their oro-naso-pharynx suctioned immediately after birth ( S Group ) , whereas 20 were not suctioned in the neonatal period ( NS Group ) . A computerized pneumotachographic system ( MECVENT ) was used for the assessment of respiratory mechanics ( Dynamic Compliance ( C. Dyn . ) and Total Pulmonary Resistance ( R ) in inspiration and expiration at 10 , 30 and 120 minutes after birth . In both groups the C. Dyn increased during the study period whereas the R decreased , mainly in the initial 30 minutes . No significant differences were observed between S and NS groups for any of the parameters of respiratory mechanics . The results obtained in this study provide no physiological basis to recommend routine airway suction at birth in normal , term , vaginally born infants Adverse changes in cerebral hemodynamics during endotracheal suctioning have been reported in conventionally ventilated newborns , whereas observations on the effect of endotracheal suctioning during high-frequency ventilation have not been reported to date . The present study was design ed to investigate the effect of endotracheal suctioning on cerebral hemodynamics in high-frequency and conventionally ventilated infants . Changes in cerebral concentration of oxygenated ( cO(2)Hb ) and deoxygenated hemoglobin ( cHHb ) and oxidized cytochrome aa3 ( cCyt.aa3 ) were measured by noninvasive near-infrared spectroscopy . In an open prospect i ve study , 26 suctioning periods in 9 high-frequency and in 6 conventionally ventilated newborn infants were investigated . Heart rate , arterial oxygen saturation ( SaO(2 ) ) , mean blood pressure ( MABP ) , and transcutaneous carbon dio OUTPUT: The currently available evidence does not support or refute the benefits or harms of routine oro/nasopharyngeal suction over no suction . INPUT: In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias BACKGROUND AND OBJECTIVE : Late-onset sepsis frequently complicates prematurity , contributing to morbidity and mortality . Probiotics may reduce mortality and necrotizing enterocolitis ( NEC ) in preterm infants , with unclear effect on late-onset sepsis . This study aim ed to determine the effect of administering a specific combination of probiotics to very preterm infants on culture-proven late-onset sepsis . METHODS : A prospect i ve multicenter , double-blinded , placebo-controlled , r and omized trial compared daily administration of a probiotic combination ( Bifidobacterium infantis , Streptococcus thermophilus , and Bifidobacterium lactis , containing 1 × 109 total organisms ) with placebo ( maltodextrin ) in infants born before 32 completed weeks ’ gestation weighing < 1500 g. The primary outcome was at least 1 episode of definite late-onset sepsis . RESULTS : Between October 2007 and November 2011 , 1099 very preterm infants from Australia and New Zeal and were r and omized . Rates of definite late-onset sepsis ( 16.2 % ) , NEC of Bell stage 2 or more ( 4.4 % ) , and mortality ( 5.1 % ) were low in controls , with high breast milk feeding rates ( 96.9 % ) . No significant difference in definite late-onset sepsis or all-cause mortality was found , but this probiotic combination reduced NEC of Bell stage 2 or more ( 2.0 % versus 4.4 % ; relative risk 0.46 , 95 % confidence interval 0.23 to 0.93 , P = .03 ; number needed to treat 43 , 95 % confidence interval 23 to 333 ) . CONCLUSIONS : The probiotics B infantis , S thermophilus , and B lactis significantly reduced NEC of Bell stage 2 or more in very preterm infants , but not definite late-onset sepsis or mortality . Treatment with this combination of probiotics appears to be safe The value of prophylactic oral gentamicin sulfate therapy in the prevention of necrotizing enterocolitis ( NEC ) was evaluated in a group of 42 high-risk neonates over a four-month period in a r and omized , double-blind controlled trial . Twenty babies in the treatment group received 2.5 mg/kg of gentamicin sulfate every six hours for one week after birth , and 22 babies received dextrose- and -water placebo in an equivalently small volume . None of the 20 gentamicin-treated babies developed NEC . Four of the control babies did . Two of these babies died , and their diagnosis was pathologically confirmed . This difference in the incidence of NEC between the treatment and control group was significant at the .05 level . These results support the prophylactic use of orally given gentamicin for selected babies at high risk for NEC , particularly those born prematurely and those who have a history of perinatal asphyxia or umbilical artery catheterization or both . Continued surveillance for changes in antimicrobial sensitivity patterns is recommended Small premature infants are often hypochlorhydric , and frequently their stomachs are colonized by enteric , gram-negative bacteria . We tested a hypothesis that gastric pH affected the colonization of the stomach with enteric bacteria and that this colonization was causally related to the risk or severity of necrotizing enterocolitis . A prospect i ve , double-blind study was conducted that compared a group of infants supplemented with 0.01–0.02 ml of 1 N HCl/ml of milk to a group with a similar supplement of water . Gastric pH , gastric enteric bacteria counts , and the incidence and severity of necrotizing enterocolitis were monitored . The median gastric pH of the HCl-supplemented group was lower ( 3.0 ) than controls ( 4.0 ) throughout the study ( p < 0.001 ) . The gastric enteric bacterial colonization rate and the quantitative bacterial counts were strongly correlated with gastric pH over 4 ( p < 0.001 ) . Somatic growth rates in infants in the HCl-supplemented group were equal to , or exceeded , those in the control group . There was 1 case of necrotizing entero-colitis among the 34 infants in the HCl-supplemented group and 8 cases among the 34 in the control group ( p = 0.02 ) . It appears that acidifying the feedings of small premature infants to a pH low enough to inhibit bacterial proliferation in the stomach significantly lowers the risk of OUTPUT:

Based on the available trials , the evidence does not support the administration of oral immunoglobulin for the prevention of NEC . There are no r and omized controlled trials of oral IgA alone for the prevention of NEC

MS2_dynamic_1_shot14

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract : The aim of this placebo-controlled , r and omized , single-masked study was to establish the effects of a 10-week ambulatory exercise programme for osteoporotic patients on pain , use of analgesics , functional status , quality of life , balance and muscle strength . Fifty-three ambulatory postmenopausal women with at least one spinal crush fracture and pains within the last 3 years were r and omized for physiotherapeutic training twice a week for 10 weeks or no training . The training included general training of balance and muscle strength , with stabilization of the lumbar spine . The participants were tested at baseline , week 5 and week 10 with a balance test , muscle strength test and question naires on pain , use of analgesics , functional status and quality of life . Twelve weeks after the supervised training had finished ( week 22 ) they answered the same question naires . The study groups were comparable at baseline . The training group had a significant reduction in use of analgesics ( p= 0.02 ) and pain level ( p= 0.01 ) during the training period . Distribution of functional score improved ; the improvement was reduced at week 22 . Quality of life score improved significantly throughout the study ( p= 0.0008 ) , even after week 22 . Balance improved non-significantly ( p= 0.08 ) . Quadriceps muscle strength improved significantly after 5 weeks ( p= 0.04 ) . Back extensor muscle strength improved almost significantly ( p= 0.09 ) . In conclusion , this training programme for osteoporotic patients improved balance and level of daily function and decreased experience of pain and use of analgesics . Quality of life was improved even beyond the active training period BACKGROUND Physical activity has been related to enhanced bone mass and improved physical functioning and thus may reduce the risk for osteoporotic fracture . OBJECTIVE To determine whether higher levels of physical activity are related to lower incidence of hip , wrist , and vertebral fractures . DESIGN Prospect i ve cohort study . SETTING Four clinical centers in Baltimore , Maryl and ; Portl and , Oregon ; Minneapolis , Minnesota ; and the Monongahela Valley , Pennsylvania . PARTICIPANTS 9704 nonblack women 65 years of age or older . MEASUREMENTS Physical activity was assessed by question naire at baseline . Hip and wrist fractures were followed for an average of 7.6 years . The incidence of vertebral fracture was determined morphometrically by using radiography at baseline and an average of 3.7 years later . RESULTS Higher levels of leisure time , sport activity , and household chores and fewer hours of sitting daily were associated with a significantly reduced relative risk for hip fracture after adjustment for age , dietary factors , falls at baseline , and functional and health status . Very active women ( fourth and fifth quintiles ) had a statistically significant 36 % reduction in hip fractures ( relative risk , 0.64 [ 95 % CI , 0.45 to 0.891 ) compared with the least active women ( lowest quintile ) . The intensity of physical activity was also related to fracture risk : Moderately to vigorously active women had statistically significant reductions of 42 % and 33 % in risk for hip and vertebral fractures , respectively , compared with inactive women . Total physical activity , hours of household chores per day , and hours of sitting per day were not significantly associated with wrist or vertebral fractures . CONCLUSIONS Among older community-dwelling women , physical activity is associated with a reduced risk for hip fracture but not wrist or vertebral fracture Physical exercise has a favorable impact on bones , but optimum training strategies are still under discussion . In this study , we compared the effect of slow and fast resistance exercises on various osteodensitometric parameters . Fifty-three postmenopausal women were r and omly assigned to a strength training ( ST ) or a power training group ( PT ) . Both groups carried out a progressive resistance training , a gymnastics session , and a home training over a period of 12 mo . During the resistance training , the ST group used slow and the PT group fast movements ; otherwise there were no training differences . All subjects were supplemented with Ca and vitamin D. At baseline and after 12 mo , bone mineral density ( BMD ) was measured at the lumbar spine , proximal femur , and distal forearm by dual-energy X-ray absorptiometry . We also measured anthropometric data and maximum static strength . Frequency and grade of pain were assessed by question naire . After 12 mo , significant between-group differences were observed for BMD at the lumbar spine ( P < 0.05 ) and the total hip ( P < 0.05 ) . Whereas the PT group maintained BMD at the spine ( + 0.7 + /- 2.1 % , not significant ) and the total hip ( 0.0 + /- 1.7 % , not significant ) , the ST group lost significantly at both sites ( spine : -0.9 + /- 1.9 % ; P < 0.05 ; total hip : -1.2 + /- 1.5 % ; P < 0.01 ) . No significant between-group differences were observed for anthropometric data , maximum strength , BMD of the forearm , or frequency and grade of pain . These findings suggest that power training is more effective than strength training in reducing bone loss in postmenopausal women Abstract Objectives To evaluate postoperative medical complications and the association between these complications and mortality at 30 days and one year after surgery for hip fracture and to examine the association between preoperative comorbidity and the risk of postoperative complications and mortality . Design Prospect i ve observational cohort study . Setting University teaching hospital . Participants 2448 consecutive patients admitted with an acute hip fracture over a four year period . We excluded 358 patients : all those aged < 60 ; those with periprosthetic fractures , pathological fractures , and fractures treated without surgery ; and patients who died before surg OUTPUT: Interventions with balance exercises reduced falls or fall-related fractures and improved balance in the majority of the studies . Muscle strengthening exercises were effective in improving lower extremity strength and back extensor strength ; however , not all RCT ’s reported positive effects . Bone strength was improved by weight-bearing aerobic exercise with or without muscle strengthening exercise when the duration of the intervention was at least a year . Conclusions Exercise can reduce falls , fall-related fractures , and several risk factors for falls in individuals with low BMD . Exercise interventions for patients with osteoporosis should include weight-bearing activities , balance exercise , and strengthening exercises to reduce fall and fracture risk INPUT: Abstract : The aim of this placebo-controlled , r and omized , single-masked study was to establish the effects of a 10-week ambulatory exercise programme for osteoporotic patients on pain , use of analgesics , functional status , quality of life , balance and muscle strength . Fifty-three ambulatory postmenopausal women with at least one spinal crush fracture and pains within the last 3 years were r and omized for physiotherapeutic training twice a week for 10 weeks or no training . The training included general training of balance and muscle strength , with stabilization of the lumbar spine . The participants were tested at baseline , week 5 and week 10 with a balance test , muscle strength test and question naires on pain , use of analgesics , functional status and quality of life . Twelve weeks after the supervised training had finished ( week 22 ) they answered the same question naires . The study groups were comparable at baseline . The training group had a significant reduction in use of analgesics ( p= 0.02 ) and pain level ( p= 0.01 ) during the training period . Distribution of functional score improved ; the improvement was reduced at week 22 . Quality of life score improved significantly throughout the study ( p= 0.0008 ) , even after week 22 . Balance improved non-significantly ( p= 0.08 ) . Quadriceps muscle strength improved significantly after 5 weeks ( p= 0.04 ) . Back extensor muscle strength improved almost significantly ( p= 0.09 ) . In conclusion , this training programme for osteoporotic patients improved balance and level of daily function and decreased experience of pain and use of analgesics . Quality of life was improved even beyond the active training period Introduction : Specific pharmacological treatment reduces the incidence of fractures significantly in patients with osteoporosis . Unfortunately , compliance with such therapy is low in clinical practice and is inversely related to educational level . We hypothesized that patients ' knowledge of osteoporosis may be increased by a group-based multidisciplinary education programme . Methods : Three hundred patients , aged 45—81 years , recently diagnosed with osteoporosis and started on specific treatment , were r and omized to either the " school ' ' or " control ' ' group . Teaching was performed by nurses , physiotherapists , dieticians , and doctors , and design ed to increase the patient 's empowerment . The patient 's knowledge of osteoporosis was tested at study entry and at 3 months using a vali date d question naire . Results : At study entry , no differences in age or score ( 22 ( 18—24 ) ( median ( 25—75 percentiles ) ) vs. 22 ( 18—24 ) ) were seen between the school and control groups . The change in knowledge during the study , however , differed significantly between the two groups ( p<0.001 ) . In the school group , the increase in knowledge score correlated inversely with the level of education ; that is , the lower the education level , the higher the gain in knowledge during the course ( Rho=-0.25 , p<0.01 ) . Conclusions : A group-based multidisciplinary education programme significantly increases patients ' knowledge of the disease OBJECTIVE To examine the effect of community-based nutrition education intervention on calcium intake and bone mass in Vietnamese postmenopausal women . DESIGN A controlled trial was conducted in two groups as intervention and control . The intervention group was given nutrition education during 18 months to improve calcium intake , while the control subjects had the usual diet . Calcium intake and bone mass were evaluated every 6 months . Bone mass was assessed by speed of sound ( SOS ) at calcaneus , referred to as quantitative ultrasound measurement . Anthropometric indices and serum parathyroid hormone ( PTH ) were determined at baseline and at the end of intervention . SETTING Two rural communes of Hai Duong province located in the Red River Delta in Vietnam . SUBJECTS A total of 140 women aged 55 - 65 years , who were more than 5 years postmenopausal and with low calcium intake ( < 400 mg/d ) , were recruited . After 18 months of intervention , 108 women completed the study . RESULTS Calcium intake in the intervention group had increased significantly ( P < 0.01 ) while it had no significant changes in controls . SOS values were not changed significantly in the intervention subjects while it decreased significantly by 0.5 % in the controls ( P < 0.01 ) . The intervention led to a decrease in serum PTH by 12 % ( P < 0.01 ) . In the controls , there was an increase in serum PTH by 32 % ( P < 0.001 ) . CONCLUSION Nutrition education intervention was effective in improving calcium intake and retarding bone loss in the studied subjects OBJECTIVE : To define the effects of therapeutic exercise on bone density and back complaints . METHODS : A r and omised controlled trial with parallel groups was conducted in an outpatient clinic , Medical School , University of Vienna . Ninety two sedentary post-menopausal women with back problems were r and omly allocated to either exercise ( groups 1 and 2 ) or control ( group 3 , no exercise , n = 31 ) ; the exercise group was retrospectively subdivided into compliant ( group 1 , n = 27 ) and not fully compliant patients ( group 2 , n = 34 ) . Regular , initially supervised therapeutic exercise aim ed at restoring biomechanical function was performed for four years . Bone density in the forearm was measured by single photon absorptiometry at entry and after four years ; subjective back complaints were documented . RESULTS : A significant decrease in bone density was observed in groups 2 and 3 ; no change was noted in group 1 ; back complaints decreased in group 1 only . CONCLUSIONS : Sedentary postmenopausal women may benefit from regular long term therapeutic exercise in terms of subjective back complaints OUTPUT:

Collectively , these studies provided some evidence to show that interventions by healthcare professionals improved the QOL medication compliance and calcium intake of patients but its effects on BMD , medication persistence , knowledge , and other lifestyle modifications were less conclusive .

MS2_dynamic_1_shot15

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format OBJECTIVE To test the feasibility , acceptability , and potential efficacy of after-school dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , among African-American girls . DESIGN Twelve-week , 2-arm parallel group , r and omized controlled trial . SETTING Low-income neighborhoods . PARTICIPANTS Sixty-one 8 - 10-year-old African-American girls and their parents/guardians . INTERVENTIONS The treatment intervention consisted of after-school dance classes at 3 community centers , and a 5-lesson intervention , delivered in participants ' homes , and design ed to reduce television , videotape , and video game use . The active control intervention consisted of disseminating newsletters and delivering health education lectures . MAIN OUTCOME MEASURES Implementation and process measures , body mass index , waist circumference , physical activity measured by accelerometry , self-reported media use , and meals eaten with TV . RESULTS Recruitment and retention goals were exceeded . High rates of participation were achieved for assessment s and intervention activities , except where transportation was lacking . All interventions received high satisfaction ratings . At follow up , girls in the treatment group , as compared to the control group , exhibited trends toward lower body mass index ( adjusted difference = -.32 kg/m2 , 95 % confidence interval [ CI ] -.77 , .12 ; Cohen 's d = .38 st and ard deviation units ) and waist circumference ( adjusted difference = -.63 cm , 95 % CI -1.92 , .67 ; d = .25 ) ; increased after-school physical activity ( adjusted difference = 55.1 counts/minute , 95 % CI -115.6 , 225.8 ; d = .21 ) ; and reduced television , videotape , and video game use ( adjusted difference = -4.96 hours/week , 95 % CI -11.41 , 1.49 ; d = .40 ) . The treatment group reported significantly reduced household television viewing ( d = .73 , P = .007 ) and fewer dinners eaten while watching TV ( adjusted difference = -1.60 meals/week , 95 % CI -2.99 , -.21 ; d = .59 ; P = .03 ) . Treatment group girls also reported less concern about weight ( d = .60 ; P = .03 ) , and a trend toward improved school grade s ( d = .51 ; P = .07 ) . CONCLUSIONS This study confirmed the feasibility , acceptability , and potential efficacy of using dance classes and a family-based intervention to reduce television viewing , thereby reducing weight gain , in African-American girls To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , OUTPUT: Pre-emptive avoidance of RGBs during the initial testing of an intervention may diminish the voltage drop between pilot and larger efficacy/effectiveness trials and enhance the odds of successful translation INPUT: Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format Feasibility and pilot studies play an important role in the preliminary planning of a proposed full-size r and omized clinical trial ( RCT ) . In essence , feasibility studies are used to help develop trial interventions or outcome measures , whereas pilot studies replicate , in miniature , a planned full-size RCT . However , the terms used for these preliminary studies are sometimes considered synonymous , and in practice may overlap considerably or be combined . The important issue is not the distinction between these : the important distinction is between such preliminary studies and a proper RCT . J Orthop Sports Phys Ther 2014;44(8):555–558 . Many factors can affect the successful implementation and validity of intervention studies . A primary purpose of feasibility and pilot studies is to assess the potential for successful implementation of the proposed main intervention studies and to reduce threats to the validity of these studies . This article describes a typology to guide the aims of feasibility and pilot studies design ed to support the development of r and omized controlled trials and provides an example of the studies underlying the development of one rehabilitation trial . The purpose of most feasibility and pilot studies should be to describe information and evidence related to the successful implementation and validity of a planned main trial . Null hypothesis significance testing is not appropriate for these studies unless the sample size is properly powered . The primary tests of the intervention effectiveness hypotheses should occur in the main study , not in the studies that are serving as feasibility or pilot studies BACKGROUND People with Multiple Sclerosis ( PwMS ) are less physically active than the general population and pragmatic approaches design ed to equip them with the skills and confidence to participate in long-term physical activity are required . OBJECTIVE The objective of this study was to determine the feasibility of a pragmatic exercise intervention in PwMS . METHODS A voluntary sample of 30 PwMS ( male n = 4 , female n = 26 ; mean age = 40 years ; range = 24 - 49 years ) , with mild to moderate disability ( EDSS ≤ 5.5 ) , were recruited from eligible participants attending outpatient clinics . A total of 28 participants were r and omised to a 10 week pragmatic exercise intervention ( 2 × supervised and 1 × home-based session per week ) or usual care . Clinical , functional and quality of life ( MSQoL-54 ) outcomes were assessed at baseline , immediately and 3 months after the intervention . RESULTS Attrition was low ( 2 participants lost to immediate follow-up and 4 participants lost to 3 month follow-up ) , with high compliance rates ( > 75 % of all sessions ) . The intervention group achieved progression of exercise volume ( 24.3 ± 7.0 to 30.9 ± 5.5 min per session ) , intensity ( 60.4 ± 8.8 to 67.7 ± 6.9 % HR max ) and training impulse ( min × average HR = training impulse/load [ arbitrary units ; AU ] ) ( 2600 ± 1105 to 3210 ± 1269AU ) during the intervention , whilst significantly increasing(P = 0.050 ) their physical composite score ( MSQOL-54 ) at 10 weeks and readiness to exercise ( P = 0.003 ) at 3 months compared with usual care . CONCLUSION This pragmatic intervention was feasible for PwMS , but further research is needed to assess its long-term impact on physical activity behaviour Background The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame . Despite an increase in research into the benefits of exercise in people with multiple sclerosis ( PwMS ) , no trial has reported detailed data on effective recruitment strategies for large-scale r and omised controlled trials . The main purpose of this report is to provide a detailed outline of recruitment strategies , rates and estimated costs in the Exercise Intervention for Multiple Sclerosis ( ExIMS ) trial to identify best practice s for future trials involving multiple sclerosis ( MS ) patient recruitment . Methods The ExIMS research ers recruited 120 PwMS to participate in a 12-week exercise intervention . Participants were r and omly allocated to either exercise or usual-care control groups . Participants were sedentary , aged 18–65 years and had Exp and ed Disability Status Scale scores of 1.0–6.5 . Recruitment strategies included attendance at MS outpatient clinics , consultant mail-out and trial awareness-raising activities . Results A total of 120 participants were recruited over the course of 34 months . To achieve this target , 369 potentially eligible and interested participants were identified . A total of 60 % of participants OUTPUT:

Our case study successfully enabled us to address the four feasibility metrics , and we provide new information on management feasibility ( i.e. estimate data completeness and estimate data entry ) and scientific outcomes feasibility ( i.e. determining data collection material s appropriateness ) . Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility .

MS2_dynamic_1_shot16

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The aim of this case series was to investigate changes in pain and pressure pain sensitivity after manual treatment of active trigger points ( TrPs ) in the shoulder muscles in individuals with unilateral shoulder impingement . Twelve patients ( 7 men , 5 women , age : 25 ± 9 years ) diagnosed with unilateral shoulder impingement attended 4 sessions for 2 weeks ( 2 sessions/week ) . They received TrP pressure release and neuromuscular interventions over each active TrP that was found . The outcome measures were pain during arm elevation ( visual analogue scale , VAS ) and pressure pain thresholds ( PPT ) over levator scapulae , supraspinatus infraspinatus , pectoralis major , and tibialis anterior muscles . Pain was captured pre-intervention and at a 1-month follow-up , whereas PPT were assessed pre- and post-treatment , and at a 1-month follow-up . Patients experienced a significant ( P < 0.001 ) reduction in pain after treatment ( mean ± SD : 1.3 ± 0.5 ) with a large effect size ( d > 1 ) . In addition , patients also experienced a significant increase in PPT immediate after the treatment ( P < 0.05 ) and one month after discharge ( P < 0.01 ) , with effect sizes ranging from moderate ( d = 0.4 ) to large ( d > 1).A significant negative association ( r(s ) = -0.525 ; P = 0.049 ) between the increase in PPT over the supraspinatus muscle and the decrease in pain was found : the greater the decrease in pain , the greater the increase in PPT . This case series has shown that manual treatment of active muscle TrPs can help to reduce shoulder pain and pressure sensitivity in shoulder impingement . Current findings suggest that active TrPs in the shoulder musculature may contribute directly to shoulder complaint and sensitization in patients with shoulder impingement syndrome , although future r and omized controlled trials are required Background Lack of habituation during repetitive stimulation is the most consistent interictal abnormality of cortical information processing observed in migraine . Preventive migraine treatments might act by stabilizing cortical excitability level and thus the habituation to external stimuli . Methods We examined the effects of preventive treatment with topiramate on migraineur ’s habituation to nociceptive stimulation . Scalp potentials were evoked by Nd-YAP Laser stimulation of the h and dorsum and supraorbital region in 13 patients with migraine without aura ( MO ) and 15 healthy volunteers ( HV ) . The exam was repeated in MO before and after treatment . Results We observed a lack of habituation and lower initial amplitudes in MO compared to HV . These abnormalities reached statistical significance for N1 LEPs component , generated in the secondary somatosensory cortex ( SII ) , but not for N2/P2 complex , generated in the insula and anterior cingulated cortex ( ACC ) . Topiramate normalized the N1 habituation pattern in MO , with a significant correlation between clinical effects and normalization of neurophysiological responses . Conclusions Our results indicate a modulating action of topiramate on cortical processing of sensorial stimuli , mainly regarding the sensory-discriminative component of pain , elaborated by SII , without a significant effect on the affective dimension of pain , in which the ACC has an important role Visually induced analgesia has been correlated with the affective content of pleasant , neutral or unpleasant pictures . The aim of the present study was to assess the effect of affective images vision on laser evoked potentials and pain perception , in a cohort of healthy subjects and migraine patients . Twenty-two healthy subjects and 24 migraine without aura patients ( recorded during the inter-critical phase ) participated in the study . Eighty-four colour slides , arranged in two blocks , each consisting of 14 pleasant , 14 unpleasant and 14 neutral images , in r and om presentation , were chosen from the International Affective Picture System . The CO(2 ) laser stimuli were delivered on the dorsum of the right h and and supra-orbital zone at 7.5-watt intensity and 25-ms duration , in basal condition and during the viewing of affective pictures . Migraine patients expressed higher scores of valence and arousal for pleasant and unpleasant pictures , compared to controls . In both groups , a late positive potential in the 400 - 700 ms time range was clear for pleasant and unpleasant pictures , but its amplitude was significantly reduced in migraine patients . The pain rating and the N2 component were reduced in both groups during the visual task compared to basal condition . In migraineurs and controls the P2 wave was reduced during the vision of pleasant pictures , compared to basal condition . This indicates that stimulation by images with different affective content reduces subjective pain for a cognitive mechanism of attentive engagement , while a special inhibition of later LEPs is produced by a positive emotional impact . In migraine , affective images are able to modulate pain perception and LEPs , differently from other modalities of distraction , suggesting a possible emotive elaboration of painful stimuli Thirty-three migraineurs and 23 healthy controls were su bmi tted to pressure algometry before and after light-induced discomfort was elicited by progressive light stimulation in a monoblind fashion . Pressure algometries were performed on the emergence of the supraorbital , infraorbital , mental and greater occipital nerves , and over the temporal muscles , always throughout the same sequence and from right to left . Measurements were carried out before and immediately after light stimulation and after 10 min of the second algometry . The final result for each site measured at each time-point was the mean of the three measurements . Light stimulation was carried out progressively until light-induced discomfort was reported , to a maximum of 20 000 lux . A heat-blocking glass protected patients ' eyes . Migraineurs presented significant and persistent drops in pain perception thresholds after light stimulation , at all sites tested ( P = 0.002 to < 0.0001 ) . These drops were not seen in controls , in whom , conversely , a OUTPUT: Importantly , lower pressure pain threshold in patients with migraine was found in local areas but not in nonlocal areas . This meta- analysis indicates that the alterations in nociceptive processing of patients with migraine may be modality , measure , and location specific . INPUT: The aim of this case series was to investigate changes in pain and pressure pain sensitivity after manual treatment of active trigger points ( TrPs ) in the shoulder muscles in individuals with unilateral shoulder impingement . Twelve patients ( 7 men , 5 women , age : 25 ± 9 years ) diagnosed with unilateral shoulder impingement attended 4 sessions for 2 weeks ( 2 sessions/week ) . They received TrP pressure release and neuromuscular interventions over each active TrP that was found . The outcome measures were pain during arm elevation ( visual analogue scale , VAS ) and pressure pain thresholds ( PPT ) over levator scapulae , supraspinatus infraspinatus , pectoralis major , and tibialis anterior muscles . Pain was captured pre-intervention and at a 1-month follow-up , whereas PPT were assessed pre- and post-treatment , and at a 1-month follow-up . Patients experienced a significant ( P < 0.001 ) reduction in pain after treatment ( mean ± SD : 1.3 ± 0.5 ) with a large effect size ( d > 1 ) . In addition , patients also experienced a significant increase in PPT immediate after the treatment ( P < 0.05 ) and one month after discharge ( P < 0.01 ) , with effect sizes ranging from moderate ( d = 0.4 ) to large ( d > 1).A significant negative association ( r(s ) = -0.525 ; P = 0.049 ) between the increase in PPT over the supraspinatus muscle and the decrease in pain was found : the greater the decrease in pain , the greater the increase in PPT . This case series has shown that manual treatment of active muscle TrPs can help to reduce shoulder pain and pressure sensitivity in shoulder impingement . Current findings suggest that active TrPs in the shoulder musculature may contribute directly to shoulder complaint and sensitization in patients with shoulder impingement syndrome , although future r and omized controlled trials are required Objectives : To investigate the test-retest reliability of the following clinical diagnostic characteristics of myofascial trigger points : taut b and , spot tenderness , jump sign , pain recognition , referred pain and local twitch responses ( LTRs ) . Design : Test-retest reliability study . Setting : This study was undertaken in an outpatient physiotherapy department . Subjects : Fifty-eight patients ( 31 males and 27 females ) with rotator cuff tendonitis were recruited into this study . Intervention : Rotator cuff muscles were assessed by an expert for the presence or absence of the main clinical diagnostic characteristics of trigger point assessment . The process was then repeated three days later by the same expert . Main measures : Outcomes included the presence or absence of : a taut b and , spot tenderness , jump sign , pain recognition , referred pain and LTRs . Results : Kappa values between testing situations for the taut b and , spot tenderness , jump sign and pain recognition were 1 . Kappa scores for referred pain ranged between 0.79 and 0.88 and for the local twitch response between 0.75 and 1 depending on the muscles under investigation . Conclusions : The presence or absence of the taut b and , spot tenderness , jump sign and pain recognition was highly reliable between sessions . Referred pain and local twitch response reliability varied depending on the muscle being studied BACKGROUND Myofascial trigger points ( MTrPs ) are commonly observed in the neck , parascapular region , and upper back muscles of patients with cervical pathology . AIM To assess the frequency of latent and active myofascial trigger point ( aMTrP ) in the neck and upper back muscles in patients with cervical radiculopathy and healthy subjects . DESIGN Controlled clinical trials . SETTING Out patients and controls . POPULATION Two hundred and forty four patients and 122 controls METHODS The patients clinical ly diagnosed as cervical radiculopathy with positive Spurling 's test and confirmed by MRI , were enrolled in this study . All subjects were examined for active and latent MTrP. In patients with cervical radiculopathy , an aMTrP was distinguished from a latent one when the referred pain elicited by exploration of the MTrP is recognized as familiar . RESULTS The patients comprised of 128 female ( 52.5 % ) and 116 male ( 47.5 % ) patients . Mean age was 44.58(20 - 65 years ) . In 125 ( 51.2 % ) of patients with cervical radiculopathy were found an aMTrP at least one muscle from upper trapezius , multifidus , splenius capitis , levator scapulae , rhomboid major , minor and deep paraspinal muscles . Number and distribution of MTrPs in patients with 244 cervical radiculopathy and in healthy controls . aMTrPs were detected most common in levator scapula ( 16.3 % ) , splenius capitis ( 14.7 % ) , rhomboid minor ( 14.3 % ) , upper part of trapezius ( 13.5 % ) , rhomboid major ( 10.2 % ) and multifidus ( 8.6 % ) muscles . Patients with cervical radiculopathy showed latent MTrP in levator scapula ( 27 % ) , splenius capitis ( 16.8 % ) , rhomboid minor ( 24.6 % ) , upper part of trapezius ( 33.2 % ) , rhomboid major ( 9 % ) and multifidus ( 8.2 % ) muscles . There was significant difference in terms of distribution of active and latent MTrPs in patients with cervical radiculopathy ( P=0.019 ) . Number of latent MTrPs in upper trapezius muscles in patients with cervical radiculopathy was more than the expected distribution . None of the subjects of control group had aMTrP. However , healthy controls showed latent MTrP in levator scapula ( OUTPUT:

Findings revealed that active and latent MTrPs were prevalent throughout all disorders , however , latent MTrPs did not consistently have a higher prevalence compared to healthy controls . Conclusions We found limited evidence supporting the high prevalence of active and latent MTrPs in patients with neck or shoulder disorders .

MS2_dynamic_1_shot17

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Resistant starch ( RS ) , a non-viscous dietary fibre , may have postpr and ial effects on appetite regulation and metabolism , although the exact effects and mechanisms are unknown . An acute r and omised , single-blind crossover study , aim ed to determine the effects of consumption of 48 g RS on appetite compared to energy and available carbohydrate-matched placebo . Twenty young healthy adult males consumed either 48 g RS or the placebo divided equally between two mixed meals on two separate occasions . Effects on appetite were assessed , using an ad libitum test meal and 24-h diet diaries for energy intake , and using visual analogue scales for subjective measures . Changes to postpr and ial glucose , insulin and C-peptide were also assessed . There was a significantly lower energy intake following the RS supplement compared to the placebo supplement at both the ad libitum test meal ( 5241 ( sem 313 ) v. 5606 ( sem 345 ) kJ , P = 0.033 ) and over the 24 h ( 12 603 ( sem 519 ) v. 13 949 ( sem 755 ) kJ , P = 0.044 ) . However , there was no associated effect on subjective appetite measures . Postpr and ial plasma glucose concentrations were not significantly different between supplements , but there was a significantly lower postpr and ial insulin response following the RS supplement ( P = 0.029 ) . The corresponding C-peptide concentrations were not significantly different , although the ratio of C-peptide to insulin was higher following the RS supplement compared to placebo ( P = 0.059 ) . These results suggest that consumption of 48 g RS , over a 24-h period , may be useful in the management of the metabolic syndrome and appetite . Further studies are required to determine the exact mechanisms Fibres which are soluble or insoluble in water have different physiochemical properties and may therefore be expected to exert different effects on post-ingestive satiety signals . This study compared the effects on short-term ( 24 h ) appetite of two equienergetic high ( 22 g ) fibre breakfasts , an equienergetic low fibre breakfast and a low energy , ' light ' breakfast . Psyllium gum ( the soluble fibre ) and wheat bran ( the insoluble fibre ) were incorporated into breakfast cereals and consumed at breakfast by sixteen healthy , normal weight males after an overnight fast using a repeated measures , counterbalanced design . Ad libitum energy intake was assessed at a test snack 1.5 h after breakfast , later in the day using food boxes and the following day using food diaries . Motivation to eat and gastrointestinal sensations were tracked for the next 24 h. Hunger ratings showed a trend towards the subjects being less hungry and they consumed significantly less energy at snack time after the high insoluble than after the high soluble fibre breakfast cereal . The soluble fibre breakfast produced a greater suppression of snack intake than the light breakfast , but smaller suppression than the other breakfasts . Interestingly there was a trend toward reduced hunger and voluntary energy consumption following the soluble fibre compared with the insoluble fibre much later in the day ( 9.5 - 13.5 h after breakfast ) although this was not significant . There was no significant effect of breakfast type on total day energy intake . The results suggest that different types of fibre modulate the timecourse of appetite control and may produce alterations in the experience of motivation and patterns of eating without necessarily effecting total energy intake Objective : To assess whether the addition of viscous fiber at an amount recommended by the US FDA to allow a ‘ low saturated fat , cholesterol , soluble fiber and coronary heart disease ’ , health cl aim label on a food package ( 1.7 g psyllium ) and /or fat ( 30 g sunflower oil and 3 g sodium propionate ) to a pasta meal would affect gastric emptying , postpr and ial glucose , insulin and GLP-1 concentrations . Design : Ten subjects participated in a two-by-two single blind r and omized crossover study . Four meals containing 50 g of available carbohydrate were consumed : pasta with or without psyllium enrichment served with a tomato sauce with ( 520 kcal per meal ) and without ( 240 kcal per meal ) fat . Blood sample s were taken for 240 min following the meal and all subjects consumed a buffet meal at the end of the study . Gastric empting was measured using the paracetamol absorption test . Blood was analysed for glucose , insulin , GLP-1 . Visual analog scales were used to record feelings of hunger , pleasantness and nausea . Results : The psyllium-enriched pasta had no significant effect on gastric emptying or the incremental area under the curve ( IAUC ) for GLP-1 , insulin or glucose compared with the control pasta . The addition of polyunsaturated fat and sodium propionate significantly increased the IAUC for GLP-1 ( P<0.001 ) , delaying gastric emptying ( P<0.002 ) , and decreasing glucose ( P<0.002 ) . Conclusions : A dose of 1.7 g psyllium did not evoke measurable effects on gastric emptying , postpr and ial GLP-1 , insulin or glucose metabolism . However the addition of 30 g of oil and 3 g of sodium propionate to the pasta did reduce gastric emptying , increase GLP-1 and reduce glucose and insulin concentrations . While this short-term study may have implication s in terms of reducing the risk of diabetes and improving coronary risk factor profiles the long term effects of these nutrients need to be studied . OUTPUT: Most fibers do not reduce appetite or energy intake in acute study design s. KEY TEACHING POINTS : • Dietary fiber intake is associated with lower body weight in epidemiologic studies . • Most acute fiber treatments ( 61 % ) did not enhance satiety . • Most acute fiber treatments ( 78 % ) did not reduce food intake . • Neither fiber type nor fiber dose were related to satiety response or food intake INPUT: Background High-amylose maize resistant starch type 2 ( HAM-RS2 ) stimulates gut-derived satiety peptides and reduces adiposity in animals . Human studies have not supported these findings despite improvements in glucose homeostasis and insulin sensitivity after HAM-RS2 intake which can lower adiposity-related disease risk . The primary objective of this study was to evaluate the impact of HAM-RS2 consumption on blood glucose homeostasis in overweight , healthy adults . We also examined changes in biomarkers of satiety ( glucagon-like peptide-1 [ GLP-1 ] , peptide YY [ PYY ] , and leptin ) and body composition determined by anthropometrics and dual-energy x-ray absorptiometry , dietary intake , and subjective satiety measured by a visual analogue scale following HAM-RS2 consumption . Methods Using a r and omized-controlled , parallel-arm , double-blind design , 18 overweight , healthy adults consumed either muffins enriched with 30 g HAM-RS2 ( n = 11 ) or 0 g HAM-RS2 ( control ; n = 7 ) daily for 6 weeks . The HAM-RS2 and control muffins were similar in total calories and available carbohydrate . Results At baseline , total PYY concentrations were significantly higher 120 min following the consumption of study muffins in the HAM-RS2 group than control group ( P = 0.043 ) . Within the HAM-RS2 group , the area under the curve ( AUC ) glucose ( P = 0.028 ) , AUC leptin ( P = 0.022 ) , and postpr and ial 120-min leptin ( P = 0.028 ) decreased independent of changes in body composition or overall energy intake at the end of 6 weeks . Fasting total PYY increased ( P = 0.033 ) in the HAM-RS2 group , but changes in insulin or total GLP-1 were not observed . Mean overall change in subjective satiety score did not correlate with mean AUC biomarker changes suggesting the satiety peptides did not elicit a satiation response or change in overall total caloric intake . The metabolic response from HAM-RS2 occurred despite the habitual intake of a moderate-to-high-fat diet ( mean range 34.5 % to 39.4 % of total calories ) . Conclusion Consuming 30 g HAM-RS2 daily for 6 weeks can improve glucose homeostasis , lower leptin concentrations , and increase fasting PYY in healthy overweight adults without impacting body composition and may aid in the prevention of chronic disease . However , between-group differences in biomarkers were not observed and future research is warranted before specific recommendations can be made . Trial registration None OBJECTIVE To observe the effects of resistant starch ( RS ) on insulin resistance ( IR ) in type 2 diabetes mellitus patients . METHODS All 40 patients with type 2 diabetes mellitus were r and omly divided into two groups : Group A and Group B. Cross- design of two stages ( I , II ) was used during observation . Group A received RS 30 g/d as an intervention group for ahead of 4 weeks ( I stage ) , while group B as a control group . Group B was given RS in late 4 weeks ( II stage ) , while Group A as served control group . Blood was taken the first day and on the latest day in each stage . Fasting blood glucose ( FBG ) , post blood glucose ( PBG ) , fructosamine ( FMN ) , total cholesterol ( TC ) , triglyceridemic ( TG ) , insulin sensitive index ( ISI ) , and body mass index ( BMI ) were measured , respectively . RESULTS As Compared with the control group , ISI was higher and FBG , PBG , TC , TG , FMN and BMI were significantly lower in intervention group ( P < 0.05 ) . CONCLUSION RS should be effective in improving IR of type 2 diabetes mellitus patients Resistant starch ( RS ) has been shown to beneficially affect insulin sensitivity in healthy individuals and those with metabolic syndrome , but its effects on human type 2 diabetes ( T2DM ) are unknown . This study aim ed to determine the effects of increased RS consumption on insulin sensitivity and glucose control and changes in postpr and ial metabolites and body fat in T2DM . Seventeen individuals with well-controlled T2DM ( HbA1c 46.6±2 mmol/mol ) consumed , in a r and om order , either 40 g of type 2 RS ( HAM-RS2 ) or a placebo , daily for 12 weeks with a 12-week washout period in between . At the end of each intervention period , participants attended for three metabolic investigations : a two-step euglycemic – hyperinsulinemic clamp combined with an infusion of [ 6,6 - 2H2 ] glucose , a meal tolerance test ( MTT ) with arterio-venous sampling across the forearm , and whole-body imaging . HAM-RS2 result ed in significantly lower postpr and ial glucose concentrations ( P=0.045 ) and a trend for greater glucose uptake across the forearm muscle ( P=0.077 ) ; however , there was no effect of HAM-RS2 on hepatic or peripheral insulin sensitivity , or on HbA1c . Fasting non-esterified fatty acid ( NEFA ) concentrations were significantly lower ( P=0.004 ) and NEFA suppression was greater during the clamp with HAM-RS2 ( P=0.001 ) . Fasting triglyceride ( TG ) concentrations and soleus intramuscular TG concentrations were significantly higher following the consumption of HAM-RS2 ( P=0.039 and P=0.027 respectively ) . Although OUTPUT:

The results indicated that there was no significant difference in the amelioration of BMI , HOMA-%S and HOMA-%B in T2DM patients between RS and the non-RS supplementation . There was no significant difference between RS and non-RS supplements in patients with simple obesity . Conclusion RS supplementation can ameliorate IR in T2DM , especially for the patients of T2DM with obesity , but not in simple obesity

MS2_dynamic_1_shot18

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective : To examine the effects of iron deficiency and its treatment by iron supplementation or a high iron diet on fatigue and general health measures in women of childbearing age . Design : R and omised controlled trial to compare supplement and dietary treatment of iron deficiency . Subjects : 44 iron deficient ( serum ferritin < 15 μg/L or serum ferritin 15–20 μg/L , plus two of the following : serum iron < 10 μmol/L , total iron binding capacity > 68 μmol/L or transferrin saturation < 15 % ) and 22 iron replete ( hemoglobin ≥120 g/L and serum ferritin > 20 μg/L ) women 18 to 50 years of age were matched for age and parity . Interventions : Iron deficient women were r and omly allocated to either iron supplementation or a high iron diet for 12 weeks . Measures of Outcome : Iron deficient and iron replete participants had iron studies performed and completed the Piper Fatigue Scale ( PFS ) and the SF-36 general health and well-being question naire at baseline ( T0 ) , following the 12 week intervention ( T1 ) and again after a six-month non-intervention phase ( T2 ) . The SF-36 includes measures of physical ( PCS ) and mental ( MCS ) health and vitality ( VT ) . Results : MCS and VT scores were lower and PFS scores were higher for iron deficient women ( diet and supplement groups ) than iron replete women at baseline . Both intervention groups showed similar improvements in MCS , VT and PFS scores during the intervention phase , but mean increases in serum ferritin were greater in the supplement than the diet group . PCS scores were not related to iron status . Conclusions : Treatment of iron deficiency with either supplementation or a high iron diet results in improved mental health and decreased fatigue among women of childbearing age Background Vegetarian diets have been associated with lower risk of chronic disease , but little is known about the health effects of low meat diets and the reliability of self-reported vegetarian status . We aim ed to establish an analytical cohort over-represented with vegetarians , pescetarians and 1 day/week meat consumers , and to describe their lifestyle and dietary characteristics . In addition , we were able to compare self-reported vegetarians with vegetarians whose status has been confirmed by their response on the extensive food frequency question naire ( FFQ ) . Study methods Embedded within the Netherl and s Cohort Study ( n = 120,852 ; including 1150 self-reported vegetarians ) , the NLCS-Meat Investigation Cohort ( NLCS-MIC ) was defined by combining all FFQ-confirmed-vegetarians ( n = 702 ) , pescetarians ( n = 394 ) , and 1 day/week meat consumers ( n = 1,396 ) from the total cohort with a r and om sample of 2–5 days/week- and 6–7 days/week meat consumers ( n = 2,965 and 5,648 , respectively ) . Results Vegetarians , pescetarians , and 1 day/week meat consumers had more favorable dietary intakes ( e.g. higher fiber/vegetables ) and lifestyle characteristics ( e.g. lower smoking rates ) compared to regular meat consumers in both sexes . Vegetarians adhered to their diet longer than pescetarians and 1 day/week meat consumers . 75 % of vegetarians with a prevalent cancer at baseline had changed to this diet after diagnosis . 50 % of self-reported vegetarians reported meat or fish consumption on the FFQ . Although the misclassification that occurred in terms of diet and lifestyle when merely relying on self-reporting was relatively small , the impact on associations with disease risk remains to be studied . Conclusion We established an analytical cohort over-represented with persons at the lower end of the meat consumption spectrum which should facilitate prospect i ve studies of major cancers and causes of death using ≥20.3 years of follow-up BACKGROUND Gene mutations associated with iron overload have been identified . How food and nutrient intakes affect iron status in persons who may be at risk of iron overload because their genetic status is unknown . OBJECTIVE The objective was to determine the relation between food and nutrient intakes , HFE genotype , and iron status . Foods and nutrients associated with iron stores , with adjustment for gene mutations associated with hemochromatosis , were explored . DESIGN A prospect i ve cohort of women aged 35 - 69 y ( the UK Women 's Cohort Study ) provided information on diet through a question naire and food diary ; 6779 women in the cohort provided cheek cell sample s , blood sample s , or both , which were genotyped for C282Y and H63D mutations , and 2489 women also had their iron status assessed . Relations between serum ferritin and iron intake were investigated by using multiple linear regression , with adjustment for potential confounders . RESULTS The strongest dietary association with serum ferritin concentration was a positive association with heme iron and not with nonheme or total iron . Weaker positive associations were seen with red and white meat , and negative associations were seen with total energy and white and brown whole-meal bread , independent of genotype and other potential confounders . The effect of genotype on ferritin concentrations primarily occurred after menopause , at which time a strong interaction between genotype and heme iron intake was observed . Other factors associated with serum ferritin concentrations were age , body mass index , blood donation , menopausal status , and HFE genotype . CONCLUSIONS Postmenopausal women eating a diet rich in heme iron and who were C282Y homozygotes had the highest serum ferritin concentrations The effects of three diets -- high meat ( HM ) , low meat ( OUTPUT: However , the optimum quantity or frequency of flesh intake required to maintain or achieve a healthy iron status remains unclear . INPUT: Our objective was to investigate the effects of iron depletion on adaptation to aerobic exercise , assessed by time to complete a 15-km cycle ergometer test . Forty-two iron-depleted ( serum ferritin < 16 microg/l ) , nonanemic ( Hb > 12 g/dl ) women ( 18 - 33 yr old ) received 100 mg of ferrous sulfate ( S ) or placebo ( P ) per day for 6 wk in a r and omized , double-blind trial . Subjects trained for 30 min/day , 5 days/wk at 75 - 85 % of maximum heart rate for the final 4 wk of the study . There were no group differences in baseline iron status or in 15-km time . Iron supplementation increased serum ferritin and decreased transferrin receptors in the S compared with the P group . The S and P groups decreased 15-km time and respiratory exchange ratio and increased work rate during the 15-km time trial after training . The decrease in 15-km time was greater in the S than in the P group ( P = 0.04 ) and could be partially attributed to increases in serum ferritin and Hb . These results indicate that iron deficiency without anemia impairs favorable adaptation to aerobic exercise BACKGROUND Iron deficiency without anemia has been shown to reduce both muscle-tissue oxidative capacity and endurance in animals . However , the consequences of iron deficiency in humans remain unclear . OBJECTIVE We investigated the effects of iron supplementation on adaptation to aerobic training among marginally iron-depleted women . We hypothesized that iron supplementation for 6 wk would significantly improve iron status and maximal oxygen uptake ( VO(2)max ) after 4 wk of concurrent aerobic training . DESIGN Forty-one untrained , iron-depleted , nonanemic women were r and omly assigned to receive either 50 mg FeSO(4 ) or a placebo twice daily for 6 wk in a double-blind trial . All subjects trained on cycle ergometers 5 d/wk for 4 wk , beginning on week 3 of the study . RESULTS Six weeks of iron supplementation significantly improved serum ferritin and serum transferrin receptor ( sTfR ) concentrations and transferrin saturation without affecting hemoglobin concentrations or hematocrit . Average VO(2)max and maximal respiratory exchange ratio improved in both the placebo and iron groups after training ; however , the iron group experienced significantly greater improvements in VO(2)max . Both iron-status and fitness outcomes were analyzed after stratifying by baseline sTfR concentration ( > and < or = 8.0 mg/L ) , which showed that the previously observed treatment effects were due to iron-status and fitness improvements among subjects with poor baseline iron status . CONCLUSIONS Our findings strongly suggest that iron deficiency without anemia but with elevated sTfR status impairs aerobic adaptation among previously untrained women and that this can be corrected with iron supplementation BACKGROUND We previously showed that iron supplementation significantly improves iron status and maximal work capacity in previously untrained , marginally iron-deficient women with a baseline serum transferrin receptor concentration > 8.0 mg/L. However , the effect of transferrin receptor status on adaptation in endurance capacity after aerobic training in these subjects has not been fully explored . OBJECTIVE Our objective was to examine the effect of baseline serum transferrin receptor status on adaptations in endurance capacity . DESIGN Forty-one untrained , iron-depleted , nonanemic women were r and omly assigned to receive either 100 mg FeSO(4 ) or a placebo for 6 wk in a double-blind trial . All subjects trained on cycle ergometers 5 d/wk for the last 4 wk of the study . Endurance capacity was assessed at baseline and after treatment by using a 15-km time trial conducted on a cycle ergometer . RESULTS Significant treatment effects were observed for time to complete the 15-km time trial , work rate , and percentage of maximal oxygen uptake in subjects with a baseline serum transferrin receptor concentration > 8.0 mg/L. No significant treatment effects were observed in subjects with a normal baseline transferrin receptor concentration . CONCLUSIONS Our findings suggest that , in the presence of overt tissue iron deficiency , iron deficiency without anemia impairs adaptation in endurance capacity after aerobic training in previously untrained women . This impairment can be corrected with iron supplementation Eighty iron-deficient , nonpregnant female workers were r and omly assigned to ferrous sulphate ( 60 or 120 mg Fe/d ) or placebo treatment for 12 wk . Energy expenditure was estimated during 3 d by heart rate ( HR ) recording . Production efficiency ( PE ) was calculated as the ratio of productivity to energy expenditure . In the iron-treated group mean hemoglobin ( Hb ) increased from 114 to 127 g/L ( P < 0.001 ) , mean serum ferritin increased from 9.7 to 30.0 micrograms/L ( P < 0.001 ) , and mean free erythrocyte protoporphyrin decreased from 1.01 to 0.49 mumol/L ( P < 0.001 ) . Mean HR at work decreased from 95.5 to 91.1 beats/min ( P < 0.001 ) , which was inversely correlated with the change in Hb ( r = -0.60 , P < 0.001 ) . PE increased significantly in the iron-treated group ( P < 0.001 ) and its change paralleled the change in Hb ( r = 0.58 , P < 0.001 ) . The results show that iron supplementation enabled these women to do the same work at a lower energy cost Studies in laboratory animals found that iron deficiency without anemia decreased oxidative capacity and increased reliance OUTPUT:

Daily iron supplementation significantly improves maximal and submaximal exercise performance in WRA , providing a rationale to prevent and treat iron deficiency in this group .

MS2_dynamic_1_shot19

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND This study examined the effects of an 8-week stress reduction program based on training in mindfulness meditation . Previous research efforts suggesting this program may be beneficial in terms of reducing stress-related symptomatology and helping patients cope with chronic pain have been limited by a lack of adequate comparison control group . METHODS Twenty-eight individuals who volunteered to participate in the present study were r and omized into either an experimental group or a nonintervention control group . RESULTS Following participation , experimental subjects , when compared with controls , evidence d significantly greater changes in terms of : ( 1 ) reductions in overall psychological symptomatology ; ( 2 ) increase in overall domain-specific sense of control and utilization of an accepting or yielding mode of control in their lives , and ( 3 ) higher scores on a measure of spiritual experiences . CONCLUSIONS The techniques of mindfulness meditation , with their emphasis on developing detached observation and awareness of the contents of consciousness , may represent a powerful cognitive behavioral coping strategy for transforming the ways in which we respond to life events . They may also have potential for relapse prevention in affective disorders Fibromyalgia is a chronic illness characterized by widespread pain , fatigue , sleep disturbance , and resistance to treatment . The purpose of this study was to evaluate the effectiveness of a meditation-based stress reduction program on fibromyalgia . Seventy-seven patients meeting the 1990 criteria of the American College of Rheumatology for fibromyalgia took part in a 10-week group outpatient program . Therapists followed a carefully defined treatment approach and met weekly to further promote uniformity . Patients were evaluated before and after the program . Initial evaluation included a psychiatric structured clinical interview ( SCID ) . Outcome measures included visual analog scales to measure global well-being , pain , sleep , fatigue , and feeling refreshed in the morning . Patients also completed a medical symptom checklist , SCL-90-R , Coping Strategies Question naire , Fibromyalgia Impact Question naire , and the Fibromyalgia Attitude Index . Although the mean scores of all the patients completing the program showed improvement , 51 % showed moderate to marked improvement and only they were counted as " responders . " These preliminary findings suggest that a meditation-based stress reduction program is effective for patients with fibromyalgia Generalized anxiety disorder ( GAD ) is a chronic anxiety disorder , associated with comorbidity and impairment in quality of life , for which improved psychosocial treatments are needed . GAD is also associated with reactivity to and avoidance of internal experiences . The current study examined the efficacy of an acceptance-based behavioral therapy aim ed at increasing acceptance of internal experiences and encouraging action in valued domains for GAD . Clients were r and omly assigned to immediate ( n = 15 ) or delayed ( n = 16 ) treatment . Acceptance-based behavior therapy led to statistically significant reductions in clinician-rated and self-reported GAD symptoms that were maintained at 3- and 9-month follow-up assessment s ; significant reductions in depressive symptoms were also observed . At posttreatment assessment 78 % of treated participants no longer met criteria for GAD and 77 % achieved high end-state functioning ; these proportions stayed constant or increased over time . As predicted , treatment was associated with decreases in experiential avoidance and increases in mindfulness Background : Mindfulness-based stress reduction ( MBSR ) proposes a systematic program for reduction of suffering associated with a wide range of medical conditions . Studies suggest improvements in general aspects of well-being , including quality of life ( QoL ) , coping and positive affect , as well as decreased anxiety and depression . Methods : A quasi-experimental study examined effects of an 8-week MBSR intervention among 58 female patients with fibromyalgia ( mean , 52 ± 8 years ) who underwent MBSR or an active social support procedure . Participants were assigned to groups by date of entry , and 6 subjects dropped out during the study . Self-report measures were vali date d German inventories and included the following scales : visual analog pain , pain perception , coping with pain , a symptom checklist and QoL. Pre- and postintervention measurements were made . Additionally , a 3-year follow-up was carried out on a subgroup of 26 participants . Results : Pre- to postintervention analyses indicated MBSR to provide significantly greater benefits than the control intervention on most dimensions , including visual analog pain , QoL subscales , coping with pain , anxiety , depression and somatic complaints ( Cohen d effect size , 0.40–1.10 ) . Three-year follow-up analyses of MBSR participants indicated sustained benefits for these same measures ( effect size , 0.50–0.65 ) . Conclusions : Based upon a quasi-r and omized trial and long-term observational follow-up , results indicate mindfulness intervention to be of potential long-term benefit for female fibromyalgia patients & NA ; Acceptance of chronic pain is emerging as an important concept in underst and ing ways that chronic pain sufferers can remain engaged with valued aspects of life . Recent studies have relied heavily on cross‐sectional investigations at a single time point . The present study sought to prospect ively investigate relations between acceptance of chronic pain and patient functioning . A sample of adults referred for interdisciplinary treatment of severe and disabling chronic pain was assessed twice , an average of 3.9 months apart . Results showed that pain and acceptance were largely unrelated . Pain at Time 2 was weakly related to measures of functioning at Time 2 . On the other h and , acceptance at Time 1 was consistently related to patient functioning at Time 2 . Those patients who reported greater acceptance at Time 1 reported better emotional , social , and physical functioning , less medication consumption , and better work status at Time 2 . These data suggest that willingness to have pain , and to engage in activity regardless of pain , can lead to healthy functioning for patients with chronic pain . Treatment outcome and process studies may demonstrate the potential for acceptance‐based clinical methods for chronic pain management OBJECTIVE The effectiveness of an attention distracting and an attention focusing OUTPUT: The quality of the studies was not found to moderate the effects of acceptance-based interventions . The results suggest that at present mindfulness-based stress reduction program and acceptance and commitment therapy are not superior to cognitive behavioral therapy but can be good alternatives . Acceptance-based therapies have small to medium effects on physical and mental health in chronic pain patients . These effects are comparable to those of cognitive behavioral therapy INPUT: Objectives : Published preliminary findings from a r and omized-controlled trial suggest that an 8-week Yoga of Awareness intervention may be effective for improving symptoms , functional deficits , and coping abilities in fibromyalgia . The primary aims of this study were to evaluate the same intervention ’s posttreatment effects in a wait-list group and to test the intervention ’s effects at 3-month follow-up in the immediate treatment group . Methods : Unpaired t tests were used to compare data from a per protocol sample of 21 women in the immediate treatment group who had completed treatment and 18 women in the wait-list group who had completed treatment . Within-group paired t tests were performed to compare posttreatment data with 3-month follow-up data in the immediate treatment group . The primary outcome measure was the Fibromyalgia Impact Question naire Revised ( FIQR ) . Multilevel r and om-effects models were also used to examine associations between yoga practice rates and outcomes . Results : Posttreatment results in the wait-list group largely mirrored results seen at posttreatment in the immediate treatment group , with the FIQR Total Score improving by 31.9 % across the 2 groups . Follow-up results showed that patients sustained most of their posttreatment gains , with the FIQR Total Score remaining 21.9 % improved at 3 months . Yoga practice rates were good , and more practice was associated with more benefit for a variety of outcomes . Discussion : These findings indicate that the benefits of Yoga of Awareness in fibromyalgia are replicable and can be maintained Background There is increasing recognition of mindfulness and mindfulness training as a way to decrease stress and increase psychological functioning . Purpose The aims of this study were to examine the effects of mindfulness stress reduction training on perceived stress and psychological well-being and to examine if changes in mindfulness mediate intervention effects on these outcomes . Methods Seventy women and one man with a previous cancer diagnosis ( mean age 51.8 years , st and ard deviation = 9.86 ) were r and omized into an intervention group or a wait-list control group . The intervention consisted of an 8-week mindfulness training course . Results Compared to participants in the control group , participants in the mindfulness training group had significantly decreased perceived stress and posttraumatic avoidance symptoms and increased positive states of mind . Those who participated in the intervention reported a significant increase in scores on the five-facet mindfulness question naire ( FFMQ ) when compared to controls . The increase in FFMQ score mediated the effects of the intervention on perceived stress , posttraumatic avoidance symptoms , and positive states of mind . Conclusions This study indicates that the improvements in psychological well-being result ing from mindfulness stress reduction training can potentially be explained by increased levels of mindfulness as measured with the FFMQ . The importance of these findings for future research in the field of mindfulness is discussed Background : Mindfulness-based stress reduction ( MBSR ) proposes a systematic program for reduction of suffering associated with a wide range of medical conditions . Studies suggest improvements in general aspects of well-being , including quality of life ( QoL ) , coping and positive affect , as well as decreased anxiety and depression . Methods : A quasi-experimental study examined effects of an 8-week MBSR intervention among 58 female patients with fibromyalgia ( mean , 52 ± 8 years ) who underwent MBSR or an active social support procedure . Participants were assigned to groups by date of entry , and 6 subjects dropped out during the study . Self-report measures were vali date d German inventories and included the following scales : visual analog pain , pain perception , coping with pain , a symptom checklist and QoL. Pre- and postintervention measurements were made . Additionally , a 3-year follow-up was carried out on a subgroup of 26 participants . Results : Pre- to postintervention analyses indicated MBSR to provide significantly greater benefits than the control intervention on most dimensions , including visual analog pain , QoL subscales , coping with pain , anxiety , depression and somatic complaints ( Cohen d effect size , 0.40–1.10 ) . Three-year follow-up analyses of MBSR participants indicated sustained benefits for these same measures ( effect size , 0.50–0.65 ) . Conclusions : Based upon a quasi-r and omized trial and long-term observational follow-up , results indicate mindfulness intervention to be of potential long-term benefit for female fibromyalgia patients & NA ; Mindfulness‐based stress reduction ( MBSR ) is a structured 8‐week group program teaching mindfulness meditation and mindful yoga exercises . MBSR aims to help participants develop nonjudgmental awareness of moment‐to‐moment experience . Fibromyalgia is a clinical syndrome with chronic pain , fatigue , and insomnia as major symptoms . Efficacy of MBSR for enhanced well‐being of fibromyalgia patients was investigated in a 3‐armed trial , which was a follow‐up to an earlier quasi‐r and omized investigation . A total of 177 female patients were r and omized to one of the following : ( 1 ) MBSR , ( 2 ) an active control procedure controlling for nonspecific effects of MBSR , or ( 3 ) a wait list . The major outcome was health‐related quality of life ( HRQoL ) 2 months post‐treatment . Secondary outcomes were disorder‐specific quality of life , depression , pain , anxiety , somatic complaints , and a proposed index of mindfulness . Of the patients , 82 % completed the study . There were no significant differences between groups on primary outcome , but patients overall improved in HRQoL at short‐term follow‐up ( P = 0.004 ) . Post hoc analyses showed that only MBSR manifested a significant pre‐to‐post‐intervention improvement in HRQoL ( P = 0.02 ) . Furthermore , multivariate analysis of secondary measures indicated modest benefits for MBSR patients . MBSR yielded significant pre‐to‐post‐intervention improvements in 6 of 8 secondary outcome variables , the OUTPUT:

No clinical or demographics explained as much variance in the FIQR total as any of the mindfulness subscales . Fibromyalgia patients experience symptoms that may be alleviated by mindfulness interventions . Baseline values for the observe subscale of the FFMQ were unexpectedly high .

MS2_dynamic_1_shot20

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To evaluate the short-term efficacy and side effects associated with two methylpheni date hydrochloride ( MPH ) dosing patterns . METHODS Twenty-five boys with attention deficit hyperactivity disorder ( ADHD ) participated in a 5-week , triple-blind , placebo-controlled , crossover evaluation of MPH administered twice ( b.i.d . ) versus thrice ( t.i.d . ) per day ( mean dose = 8.8 + /- 5 mg , .30 + /- .1 mg/kg/dose ) . Four dosing conditions ( placebo , titration [ gradual increase to target dose ] , b.i.d . , and t.i.d . ) were used . Dependent measures obtained on a weekly basis included : parent and teacher ratings of child behavior , parent-child conflicts , parent report of stimulant side effects , child self-report of mood symptoms , a sleep log , laboratory measures of attention , and actigraphic recording of sleep activity . RESULTS All dosing conditions result ed in significant effects on ADHD symptoms when compared with baseline . Relative to placebo , t.i.d . dosing was characterized by improvement on the greatest number of behavioral measures , and both b.i.d . and t.i.d . were generally more effective than titration . Direct comparisons of b.i.d . and t.i.d . dosing revealed that t.i.d . was associated with greater improvement on the Conners Parent Rating Scale Impulsivity/Hyperactivity factor , with a similar marginally significant effect for the ADD-H Teacher Rating Scale Hyperactivity factor . The analysis of clinical ly significant change favored a three-times-a-day dosing schedule over placebo on both parent and teacher ratings of impulsivity/hyperactivity and attention . Compared with placebo , appetite suppression was rated , on average , as more severe in the t.i.d . and titration conditions , but not in the b.i.d . condition . However , the number of subjects who exhibited any or severe appetite suppression did not differ significantly between the b.i.d . and t.i.d . schedules . Although there was no difference in sleep duration for children on b.i.d . and t.i.d . schedules , total sleep time appeared to decrease slightly on t.i.d . relative to placebo according to both parent ratings and actigraphic assessment . There were no significant differences between b.i.d . and t.i.d . on any other side effects or sleep variables . CONCLUSIONS For many children with ADHD , t.i.d . dosing may be optimal . There are few differences in acute side effects between b.i.d . and t.i.d . MPH dosing . The dosing schedule should be selected according to the severity and time course of ADHD symptoms rather than in anticipation of dosing schedule-related side effects Background This study examined augmenting atomoxetine with extended-release methylpheni date in children whose attention-deficit/hyperactivity disorder ( ADHD ) previously failed to respond adequately to stimulant medication . Methods Children with ADHD and prior stimulant treatment ( N = 25 ) received atomoxetine ( 1.2 mg/kg/day ) plus placebo . After 4 weeks , patients who were responders ( n = 4 ) were continued on atomoxetine/placebo while remaining patients were r and omly assigned to either methylpheni date ( ATX/MPH ) ( 1.1 mg/kg/day ) or placebo augmentation ( ATX/PB ) for another 6 weeks . Patients and sites were blind to timing of active augmentation . Safety measures included vital signs , weight , and adverse events . Efficacy was assessed by ADHD rating scales . Results Categorical increases in vital signs occurred for 5 patients ( 3 patients in ATX/MPH , 2 patients in ATX/PBO ) . Sixteen percent discontinued the study due to AE , but no difference between augmentation groups . Atomoxetine treatment was efficacious on outcome measures ( P ≤ .001 ) , but methylpheni date did not enhance response . Conclusion Methylpheni date appears to be safely combined with atomoxetine , but conclusions limited by small sample . With atomoxetine treatment , 43 % of patients achieved normalization on ADHD ratings Abstract Hypotheses concerning unexpected , psychostimulant-related effects reported in previous studies were examined by separating behavioral/physical complaints highly specific to methylpheni date ( MPH ) from those that ( a ) may mimic core/ secondary symptoms of the disorder , or ( b ) are commonly reported by unmedicated children in the general population . Sixty-five children with attention-deficit/hyperactivity disorder ( ADHD ) participated in a double-blind , placebo-controlled , within-subject ( crossover ) experimental design and received a placebo and four MPH doses in counterbalanced order following baseline assessment . Behavioral and physical complaints were significantly higher under baseline relative to placebo and the four immediate-release MPH conditions ( 5 mg , 10 mg , 15 mg , and 20 mg ) across three symptom categories : ADHD core/ secondary symptoms ; symptoms commonly reported in the general population , including unmedicated children with ADHD ; and symptoms highly specific to MPH . No significant differences were found among active drug conditions . Past unexpected findings of psychostimulant effects in ADHD may be due to the inclusion of scale items that reflect core/ secondary features of ADHD and normally occurring behavioral/physical complaints in children OBJECTIVE To evaluate the efficacy and safety of osmotic-release methylpheni date ( OROS-MPH ) compared with placebo for attention-deficit/hyperactivity disorder ( ADHD ) , and the impact on substance treatment outcomes in adolescents concurrently receiving cognitive-behavioral therapy ( CBT ) for substance use disorders ( SUD ) . METHOD This was a 16-week , r and omized , controlled , multi-site trial of OROS-MPH + CBT versus placebo + CBT in 303 adolescents ( aged 13 through OUTPUT: Methylpheni date increases the risks of decreased appetite , weight loss , and abdominal pain in children and adolescents with attention deficit hyperactivity disorder . No differences in the risks of gastrointestinal adverse events according to type , dose , or duration of administration were found INPUT: Objective : Stimulant medications , such as methylpheni date ( MPH ) , improve the academic performance of children with attention-deficit hyperactivity disorder ( ADHD ) . However , the mechanism by which MPH exerts an effect on academic performance is unclear . We examined MPH effects on math performance and investigated possible mediation of MPH effects by changes in time on-task , inhibitory control , selective attention , and reaction time variability . Methods : Children with ADHD aged 7 to 11 years ( N = 93 ) completed a timed math worksheet ( with problems tailored to each individual 's level of proficiency ) and 2 neuropsychological tasks ( Go/No-Go and Child Attention Network Test ) at baseline , then participated in a 4-week , r and omized , controlled , titration trial of MPH . Children were then r and omly assigned to their optimal MPH dose or placebo for 1 week ( administered double-blind ) and repeated the math and neuropsychological tasks ( posttest ) . Baseline and posttest videorecordings of children performing the math task were coded to assess time on-task . Results : Children taking MPH completed 23 more math problems at posttest compared to baseline , whereas the placebo group completed 24 fewer problems on posttest versus baseline , but the effects on math accuracy ( percent correct ) did not differ . Path analyses revealed that only change in time on-task was a significant mediator of MPH 's improvements in math productivity . Conclusions : MPH-derived math productivity improvements may be explained in part by increased time spent on-task , rather than improvements in neurocognitive parameters , such as inhibitory control , selective attention , or reaction time variability OBJECTIVE Methylpheni date ( MPH ) , the most commonly prescribed drug for attention-deficit/hyperactivity disorder ( ADHD ) , has a short half-life , which necessitates multiple daily doses . The need for multiple doses produces problems with medication administration during school and after-school hours , and therefore with compliance . Previous long-acting stimulants and preparations have shown effects equivalent to twice-daily dosing of MPH . This study tests the efficacy and duration of action , in natural and laboratory setting s , of an extended-release MPH preparation design ed to last 12 hours and therefore be equivalent to 3-times-daily dosing . METHODS Sixty-eight children with ADHD , 6 to 12 years old , participated in a within-subject , double-blind comparison of placebo , immediate-release ( IR ) MPH 3 times a day ( tid ) , and Concerta , a once-daily MPH formulation . Three dosing levels of medication were used : 5 mg IR MPH tid/18 mg Concerta once a day ( qd ) ; 10 mg IR MPH tid/36 mg Concerta qd ; and 15 mg IR MPH tid/54 mg Concerta qd . All children were currently medicated with MPH at enrollment , and each child 's dose level was based on that child 's MPH dosing before the study . The doses of Concerta were selected to be comparable to the daily doses of MPH that each child received . To achieve the ascending rate of MPH delivery determined by initial investigations to provide the necessary continuous coverage , Concerta doses were 20 % higher on a daily basis than a comparable tid regimen of IR MPH . Children received each medication condition for 7 days . The investigation was conducted in the context of a background clinical behavioral intervention in both the natural environment and the laboratory setting . Parents received behavioral parent training and teachers were taught to establish a school-home daily report card ( DRC ) . A DRC is a list of individual target behaviors that represent a child 's most salient areas of impairment . Teachers set daily goals for each child 's impairment targets , and parents provided rewards at home for goal attainment . Each weekday , teachers completed the DRC , and it was used as a dependent measure of individualized medication response . Teachers and parents also completed weekly st and ardized ratings of behavior and treatment effectiveness . To evaluate the time course of medication effects , children spent 12 hours in a laboratory setting on Saturdays and medication effects were measured using procedures and methods adapted from our summer treatment program . Measures of classroom behavior and academic productivity/accuracy were taken in a laboratory classroom setting during which children completed independent math and reading worksheets . Measures of social behavior were taken in structured , small-group board game setting s and unstructured recess setting s. Measures included behavior frequency counts , academic problems completed and accuracy , independent observations , teacher and counselor ratings , and individualized behavioral target goals . Reports of adverse events , sleep quality , and appetite were collected . RESULTS On virtually all measures in all setting s , both drug conditions were significantly different from placebo , and the 2 drugs were not different from each other . In children 's regular school setting s , both medications improved behavior as measured by teacher ratings and individualized target behaviors ( the DRC ) ; these effects were seen into the evening as measured by parent ratings . In the laboratory setting , effects of Concerta were equivalent to tid MPH and lasted at least through 12 hours after dosing . Concerta was significantly superior to tid MPH on 2 parent rating scores , and when asked , more parents preferred Concerta than preferred tid IR MPH or placebo . Side effects on children 's sleep and appetite were similar for the 2 preparations . In the lab setting , both medications improved productivity and accuracy on arithmetic seatwork assignments , disruptive and on-task behavior , and classroom rule following . Both medications improved children 's rule following and negative behavior in small group board games , as well as in unstructured recess setting s. Individual target behaviors also showed significant improvement with medication across domains in the laboratory setting . Children 's behavior across setting s deteriorated across the laboratory day , and the primary effect of medication was to prevent this deterioration as the day wore on . Results support the use of background behavioral treatment in clinical trials of stimulant medication , and illustrate the utility of a measure of individualized daily target goals ( ie , the DRC ) as an objective measure of medication response in both the laboratory and OUTPUT:

None of the mediators or moderators tested affected methylpheni date efficacy . Academic improvements were small compared to symptom improvements ; qualitative changes limited to math .

MS2_dynamic_1_shot21

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Falls warrant investigation as a risk factor for nursing home admission because falls are common and are associated with functional disability and because they may be preventable . METHODS We conducted a prospect i ve study of a probability sample of 1103 people over 71 years of age who were living in the community . Data on demographic and medical characteristics , use of health care , and cognitive , functional , psychological , and social functioning were obtained at base line and one year later during assessment s in the participants ' homes . The primary outcome studied was the number of days from the initial assessment to a first long-term admission to a skilled-nursing facility during three years of follow-up . Patients were assigned to four categories during follow-up : those who had no falls , those who had one fall without serious injury , those who had two or more falls without serious injury , and those who had at least one fall causing serious injury . RESULTS A total of 133 participants ( 12.1 percent ) had long-term admissions to nursing homes . In an unadjusted model , the risk of admission increased progressively , as compared with that for the patients with no falls , for those with a single noninjurious fall ( relative risk , 4.9 ; 95 percent confidence interval , 3.2 to 7.5 ) , those with multiple noninjurious falls ( relative risk , 8.5 ; 95 percent confidence interval , 3.4 to 21.2 ) , and those with at least one fall causing serious injury ( relative risk , 19.9 ; 95 percent confidence interval , 12.2 to 32.6 ) . Adjustment for other risk factors lowered these ratios to 3.1 ( 95 percent confidence interval , 1.9 to 4.9 ) for one noninjurious fall , 5.5 ( 95 percent confidence interval , 2.1 to 14.2 ) for two or more noninjurious falls , and 10.2 ( 95 percent confidence interval , 5.8 to 17.9 ) for at least one fall causing serious injury , but the association between falls and admission to a nursing home remained strong and significant . The population attributable risk of long-term admission to a nursing home for these three groups ( the proportion of admissions directly attributable to the three categories of falls ) was 13 percent , 3 percent , and 10 percent , respectively . CONCLUSIONS Among older people living in the community falls are a strong predictor of placement in a skilled-nursing facility ; interventions that prevent falls and their sequelae may therefore delay or reduce the frequency of nursing home admissions BACKGROUND We previously showed that human muscle protein synthesis ( MPS ) increased during infusion of amino acids ( AAs ) and peaked at ≈120 min before returning to baseline rates , despite elevated plasma AA concentrations . OBJECTIVE We tested whether a protein meal elicited a similar response and whether signaling responses that regulate messenger RNA translation matched MPS changes . DESIGN Eight postabsorptive healthy men ( ≈21 y of age ) were studied during 8.5 h of primed continuous infusion of [1,2-¹³C₂]leucine with intermittent quadriceps biopsies for determination of MPS and anabolic signaling . After 2.5 h , subjects consumed 48 g whey protein . RESULTS At 45 - 90 min after oral protein bolus , mean ( ± SEM ) myofibrillar protein synthesis increased from 0.03 ± 0.003 % to 0.10 ± 0.01%/h ; thereafter , myofibrillar protein synthesis returned to baseline rates even though plasma essential AA ( EAA ) concentrations remained elevated ( + 130 % at 120 min , + 80 % at 180 min ) . The activity of protein kinase B ( PKB ) and phosphorylation of eukaryotic initiation factor 4 G preceded the rise of MPS and increases in phosphorylation of ribosomal protein kinase S6 ( S6K1 ) , and 4E-binding protein 1 ( 4EBP1 ) was superimposable with MPS responses until 90 min . However , although MPS decreased thereafter , all signals , with the exception of PKB activity ( which mirrored insulin responses ) , remained elevated , which echoed the slowly declining plasma EAA profile . The phosphorylation of eukaryotic initiation factor 2α increased only at 180 min . Thus , discordance existed between MPS and the mammalian target of rapamycin complex 1 ( mTORC1 ) and signaling ( ie , S6K1 and 4EBP1 phosphorylation ) . CONCLUSIONS We confirm our previous findings that MPS responses to AAs are transient , even with oral protein bolus . However , changes in MPS only reflect elevated mTORC1 signaling during the upswing in MPS Men have more muscle than women , but most studies evaluating sex differences in muscle protein metabolism have been unable to discern sexual dimorphism in basal muscle protein turnover rates in young and middle-aged adults . We hypothesized that the anabolic response to nutritional stimuli ( i.e. , amino acids and insulin ) would be greater in young/middle-aged men than women . We therefore measured the rates of muscle protein synthesis ( MPS ) in 16 healthy individuals [ 8 men and 8 women , matched for age ( mean + /- SE : 37.7 + /- 1.5 yr ) and body mass index ( 25.2 + /- 0.7 kg/m2 ) ] after an overnight fast ( plasma insulin approximately 5 microU/ml and plasma phenylalanine approximately 60 microM ) and during a hyperinsulinemic-hyperaminoacidemic-euglycemic clamp ( plasma insulin approximately 28 microU/ml ; plasma phenylalanine approximately 110 microM ; plasma glucose approximately 5.4 mM ) . The rates of MPS were not different between men OUTPUT: Conclusions /interpretationThis study demonstrates the complex role of insulin in regulating skeletal muscle metabolism . Insulin appears to have a permissive role in MPS in the presence of elevated AAs , and plays a clear role in reducing MPB independent of AA availability INPUT: A population -based cohort study was done to estimate the incidence of different types of injuries and to evaluate certain risk factors in an urban slum ; 4333 slum dwellers in Madras city in India were r and omly selected by cluster sampling , of whom 1.7 per cent were lost during the 12 months of follow up . The cumulative injury incidence for 12 months for all injuries was 127 per 1000 persons ( 95 per cent confidence interval 117 - 137 ) ; for males 137 per 1000 and for females 118 per 1000 . Incidence of unintentional injury was 121 per 1000 persons . The incidence for road traffic injury was 16 per 1000 persons , for household injuries 57 per 1000 persons and for injury at place of work 19 per 1000 persons . The relative risk of males to females for traffic injuries was 3.04 and for household injuries was 0.39 . The relative risk of traffic injuries among adult males who reported daily alcohol consumption was 2.26 . The incidence of injury is high in an urban slum and it is a priority health problem . This study has identified groups of people who are at high risk for injuries and who may need specific protective measures This pilot aims to better underst and the market for childcare in Saudi Arabia – both the supply and dem and sides – and to design a r and omized controlled experiment to test whether access to affordable day care ( in the form of subsidies , for example ) would incentivize Saudi mothers to search actively for employment and to remain employed once they are hired . In addition , the study seeks to underst and the degree to which employment early on in one ’s life impacts employment in later stages . The pilot will provide information on the groups of women the experiment should target , appropriate levels for the childcare subsidy , and the quality and current geographic locations of daycare sites . Expected Impact Determine the effects of facilitating childcare access on Saudi women ’s employment . PRINCIPAL INVESTIGATORS  Boston University Patricia Cortes  Harvard University Claudia Goldin  Swarthmore College Jennifer It is desirable that young women with primary ovarian failure achieve normal peak bone mass to reduce the subsequent risk of osteoporosis , and that there are management strategies to replace bone that is already lost . While estrogen ( E2 ) is generally considered to prevent bone loss by suppressing bone resorption , it is now recognized that estrogen also exerts an anabolic effect on the human skeleton . In this study , we tested whether estrogen could increase bone mass in women with primary ovarian failure . We studied the mechanism underlying this by analyzing biochemical markers of bone turnover and iliac crest biopsy specimens obtained before and 3 years after E2 replacement . Twenty-one women with Turner 's syndrome , aged 20 - 40 years , were studied . The T scores of bone mineral density at lumbar spine and proximal femur at baseline were -1.4 and -1.1 , respectively . Hormone replacement was given as subcutaneous E2 implants ( 50 mg every 6 months ) with oral medroxy progesterone . Serum E2 levels increased incrementally from 87.5 pM at baseline to 323 , 506 , 647 , and 713 pM after 6 months and 1 , 2 , and 3 years of hormone replacement therapy ( HRT ) , respectively . The bone mineral density at the lumbar spine and proximal femur increased after 3 years to T scores of -0.2 and -0.4 , respectively . The cancellous bone volume increased significantly from 13.4 % to 18.8 % . There was a decrease in activation frequency , but the active formation period was increased by HRT . There was a significant increase in the wall thickness from 33.4 microm at baseline to 40.9 microm after 3 years of HRT , reflecting an increase in bone formed at individual remodeling units . Although there was an early increase in biochemical markers of bone formation , these declined thereafter . Our results show that estrogen is capable of exerting an anabolic effect in the skeleton of young women with Turner 's syndrome and low bone mass The aim of the present study was to examine the impact of sequential change in the route of estrogen administration on body composition and insulin resistance in patients with Turner syndrome ( TS ) using cyclical hormone replacement therapy ( HRT ) with conjugated equine estrogens ( CEE ) plus medroxyprogesterone acetate ( MPA ) . We carried out a self-controlled study of nine non-obese patients with TS , with an average age of 23 ± 4.9 years . Body mass index ( BMI ) , waist-to-hip ratio ( WHR ) , fasting glycemia , insulin tolerance ( glucose disappearance constant during an insulin tolerance test , kITT ) and body composition ( dual-energy X-ray absorptiometry ) were studied after 1 year 's use of CEE plus MPA and repeated after 1 year 's use of 17β-estradiol gel with the same schedule of MPA administration . We did not observe any difference between the oral and percutaneous HRT with regard to BMI , WHR and insulin tolerance ( kITT : 4.9 ± 1.5 vs. 5.3 ± 1.5%/min , p = 0.8 ) . During administration of the 17β-estradiol gel a tendency to increased total lean mass ( p = 0.054 ) was observed . We conclude that sequential change in the route of estrogen administration in TS patients using cyclical HRT with CEE and MPA does not affect insulin resistance , although use of percutaneous 17β-estradiol gel seems to exert favorable changes in body composition Background There are limited long-term r and omized controlled trials of growth hormone ( GH ) supplementation to adult height and few published OUTPUT:

Using r and om-effects models , estrogen replacement therapy showed an increase in bone mineral density [ weighted mean change from baseline 0.09 g/cm2 ( 0.04–0.14 ) ] that differed by type of estrogen but not route of administration . Oral estrogen replacement therapy showed a higher increase in high density lipoprotein cholesterol levels when compared to transdermal [ weighted mean difference 9.33 mg/dl ( 4.82–13.85 ) ] with no significant effect on other lipid fractions . The current evidence suggests possible benefit of estrogen replacement therapy on bone mineral density and high density lipoprotein cholesterol .

MS2_dynamic_1_shot22

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Study Design . A question naire was mailed to 3000 r and omly selected 35‐45‐year‐old individuals in three communities in central Sweden . Objectives . To study the 1‐year prevalence of spinal pain and its ramifications in the form of pain , function , sick leave , and health care use . Summary of Background Data . Previous research ers have used a variety of definitions and population s , but primarily have investigated the occurrence of pain . Comprehensive data are needed concerning health care use , the degree of the pain problem , functional disturbances , and sick leave . Method . Participants in the study completed a question naire regarding spinal pain during the past year including the degree of their experienced pain , functional impairment , lost work days , and health care use . Results . A total of 2305 people ( 78.5 % ) responded to the question naire . Nonrespondents had similar characteristics but a slightly lower 1‐year prevalence rate than did respondents . For respondents , the prevalence of spinal pain during the past year was 66.3 % , with women having a slightly higher prevalence than men . Approximately 25 % of the respondents indicated that they had a substantial problem based on ratings of pain , functional impairment , and sick leave . Work absenteeism reported to the Public Social Insurance Office involved 19 % of those with pain , but an additional 15 % indicated unreported absenteeism . On average , those with pain visited health care providers three times during the past year , but a small number of those who experienced pain consumed large amounts of health care and illness benefits . An important gender difference was shown , such that when pain was at its worst , men took sick leave , whereas women sought health care . Conclusions . Taken together , these data indicate that spinal pain is common among 35‐45‐year‐old men and ‐ women , and that it is related to marked problems for approximately one fourth of those who experience pain . Gender differences exist in the pattern of sick leave and health care use , and a small proportion of those with pain consume very large amounts of the re sources . Consequently , there is a need for early , effective , preventive treatments Abstract The inability to predict outcome in patients with low back/neck pain leads to inappropriate or unnecessary treatment . The aims of the study were to identify prognostic factors for disability at 1‐year follow‐up in patients with back pain visiting primary care , and to compare the effect of these in two treatment strategies – chiropractic and physiotherapy . Data were taken from a r and omised trial on patients with back/neck pain visiting the general practitioner , in which patients were allocated to chiropractic and physiotherapy as primary management . Three hundred and twenty‐three patients , aged 18–60 years , who had no contraindications to manipulation and who had not been treated within the previous month were included in the study . Multiple regression analysis was used to identify prognostic factors . Dependent variables were mean Oswestry score and mean change in Oswestry score at 12‐month follow‐up . The multiple regression analysis revealed five significant ( P<0.001–0.01 ) prognostic factors ; duration of current episode , Oswestry score at entry , expectations of treatment , number of localisations , and well‐being . Besides , the regression coefficients for the significant factors were compared between the two treatment strategies . No significant difference in effect or regression coefficients for the prognostic factors were seen between the two treatment strategies . Twelve per cent of the patients had poor prognostic factors ( duration ≥1 month , more than one localisation , low expectations of treatment and low well‐being ) at entry . These patients had a mean Oswestry score above 20 % at 1‐year follow‐up . Clinical decision models for the management of patients with back pain visiting primary care that consider prognostic factors need to be implemented and prospect ively evaluated We have conducted a prospect i ve trial of the management of 135 adult patients who had sustained soft-tissue injuries of the neck in vehicle accidents . Early traction and physiotherapy was compared with rest in a collar and unsupervised mobilisation . No benefit from the active treatment could be identified ; moulded collars in slight flexion gave the best pain relief and are recommended From January 1993 to December 1996 , we treated 482 cases of cervical spondylopathy with a combined method of point-injection and needle-warming via moxibustion . Except for the cases of sympathetic nerve type and spinal cord type , the combined method was superior to traction therapy in the control group and reported as follows . Clinical Data The Criteria of Diagnosis and Curative Effect in TCM issued by the State Administrative Bureau of TCM and Pharmacy in 1994 was adopted for the enrollment of patients of cervical spondylopathy and the pathological typing . Only the patients who had completed the treatment and with complete records were collected for analysis A prospect i ve , controlled clinical trial was undertaken to assess the relative efficacies of physiotherapy and electroacupuncture in the treatment of cervical spondylosis . The results suggested that , while both methods were effective , electroacupuncture produced an earlier symptomatic improvement with increased neck movement , especially in patients with mild degenerative changes of the cervical spine A r and omized clinical trial was conducted to evaluate the efficacy of three commonly employed forms of traction in the treatment of cervical spine disorders . One hundred consenting men and women with disorders of the cervical spine were r and omly assigned to one of four treatment groups , static traction , intermittent traction , manual traction , or no traction . All patients , regardless of group assignment , were seen twice weekly . The four groups were shown to be similar with regard to age , sex , diagnosis , chronicity , and prescores on the seven outcome measures . Although the entire cohort of neck patients , regardless of group assignment , improved significantly on all the outcome variables over the 6-week period , patients receiving intermittent traction performed significantly better than those assigned to the no traction group in terms of pain ( P = 0.03 ) , forward flexion ( P = 0.01 ) , right rotation ( P = 0.004 ) and left rotation ( P = 0.05 ) Method OUTPUT: Our review revealed low- quality trials for mechanical neck disorders , showing evidence of benefit favouring intermittent traction for pain reduction . Continuous traction showed no significant difference for defined outcomes . INPUT: & NA ; A series of health surveys are conducted every sixth to seventh year in Denmark . In the most recent survey of 2000 , a national r and om sample ( > 16 years ) was drawn from the Danish Central Personal Register . Out of the original sample 12,333 ( 74 % ) were interviewed and of these 10,066 returned a completed question naire ( SF‐36 ) . The present study includes only those who both took part in the interview and the postal question naire . Cancer patients were excluded . Persons suffering from chronic pain ( PG ) were identified through the question ‘ Do you have chronic/long lasting pain lasting 6 months or more ’ ? An overall chronic pain prevalence of 19 % was found −16 % for men and 21 % for women . Prevalence of chronic pain increased with increasing age . Persons ≥67 years had 3.9 higher odds of suffering from chronic pain than persons in the age group 16–24 years . Compared with married persons , divorced or separated persons had 1.5 higher odds of chronic pain . Odds for chronic pain were 1.9 higher among those with an education of less than 10 years compared with individuals with an education of 13 years or more . During a 14‐day period reporters of chronic pain had an average of 0.8 days ( range 0–10 ) lost due to illness compared with an average of 0.4 days ( range 0–10 ) for the control group ( CG ) ( Odds Ratio ( OR ) ) 2.0 ) . Persons with a job which required high physical strain were more likely to report chronic pain compared with those with a sedentary job ( OR 2.2 ) . The odds of quitting one 's job because of ill health were seven times higher among people belonging to the PG . A strong association between chronic pain and poor self‐rated health was also demonstrated . The PG had twice as many contacts with various health professionals compared with the CG , and the health care system was , on average , utilised 25 % more ( overall contacts ) by the PG than by the general population . Among the persons in the PG , 33 % were not satisfied with the examinations carried out in connection with their pain condition and 40 % were not satisfied with the treatment offered . Nearly 130,000 adults , corresponding to 3 % of the Danish population , use opioids on a regular basis . Opioids are used by 12 % of the PG Correctable weaknesses in the design , conduct , and analysis of biomedical and public health research studies can produce misleading results and waste valuable re sources . Small effects can be difficult to distinguish from bias introduced by study design and analyses . An absence of detailed written protocol s and poor documentation of research is common . Information obtained might not be useful or important , and statistical precision or power is often too low or used in a misleading way . Insufficient consideration might be given to both previous and continuing studies . Arbitrary choice of analyses and an overemphasis on r and om extremes might affect the reported findings . Several problems relate to the research workforce , including failure to involve experienced statisticians and method ologists , failure to train clinical research ers and laboratory scientists in research methods and design , and the involvement of stakeholders with conflicts of interest . Inadequate emphasis is placed on recording of research decisions and on reproducibility of research . Finally , reward systems incentivise quantity more than quality , and novelty more than reliability . We propose potential solutions for these problems , including improvements in protocol s and documentation , consideration of evidence from studies in progress , st and ardisation of research efforts , optimisation and training of an experienced and non-conflicted scientific workforce , and reconsideration of scientific reward systems Background and Objective : Psychological factors are assumed to predict persistent or recurrent musculoskeletal pain . The influence of psychological factors in patients with low-back pain ( LBP ) or shoulder pain was explored to study whether there is similarity regarding the factors that predict persisting pain and disability . Methods : Patients presenting in primary care with a new episode of shoulder pain or non-specific (sub)acute low back pain ( LBP ) were enrolled in a prospect i ve study . In both patient groups , pain catastrophising , distress , somatisation and fear-avoidance beliefs were measured at baseline . Primary outcome measures at 3 months were ( 1 ) persistent symptoms , and ( 2 ) < 30 % reduction in functional disability . Multivariate logistic regression analysis was used to study the associations between psychological factors and outcome . Results : A total of 587 patients with shoulder pain and 171 patients with LBP were enrolled in the study . In patients with shoulder pain , most associations of psychological factors with outcome were weak and not significant . Only in patients with longer symptom duration at baseline ( ⩾3 months ) were higher scores on catastrophising significantly associated with persistent symptoms ( p = 0.04 ) . In patients with LBP , psychological factors were more strongly associated with poor outcome , although most associations were not significant . Conclusion : Psychological factors , with the exception of fear-avoidance beliefs , are more strongly associated with persistent pain and disability in patients with LBP than in those with shoulder pain . This seems to indicate that in a primary care population the influence of psychological factors on outcome may vary across patients with different types of pain A clinical prediction rule to identify patients most likely to respond to spinal manipulation has been published and widely cited but requires further testing for external validity . We performed a pre-planned secondary analysis of a r and omised controlled trial investigating the efficacy of spinal manipulative therapy in 239 patients presenting to general practice clinics for acute , non-specific , low back pain . Patients were r and omised to receive spinal manipulative therapy or placebo 2 to 3 times per week for up to 4 weeks . All patients received general practitioner care ( advice and paracetamol ) . Outcomes were pain and disability measured at 1 , 2 , 4 and 12 weeks . Status on the clinical prediction rule was measured at baseline . The clinical prediction rule performed no better than chance in identifying patients with acute , non-specific low back pain most likely to respond to spinal manipulative therapy ( pain P = 0. OUTPUT:

Several factors were found to be associated with disability at follow-up for at least two different pain symptoms . However , owing to insufficient studies , no generic risk factors for sick leave were identified . Conclusions Multiple site pain , high pain severity , older age , baseline disability and longer pain duration were identified as potential prognostic factors for disability across pain sites . There was limited evidence that anxiety and depression were associated with disability in patients with subacute pain , indicating that these factors may not play as large a role as expected in developing disability due to a pain condition .

MS2_dynamic_1_shot23

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This study evaluated differences in sitting habits in the classroom between the project " Moving school " and a traditional school in 8-year-old children . Twenty-two children , since 1.5 years involved in the project were compared to 25 children in a traditional school . Making use of the Portable Ergonomic Observation ( PEO ) method , it was observed that children from a traditional school spend an average of 97 % of the lesson time sitting statically , from which one-third with the trunk bend over 45 degrees . In the " Moving school " this posture was replaced by dynamic sitting ( 53 % ) , st and ing ( 31 % ) and walking around ( 10 % ) , while trunk flexion over 45 degrees was nearly not observed . Children from the " Moving school " also showed significantly less neck and trunk rotation . Additionally , accelerometric data showed significantly more physical activity in lessons of the " Moving school " . Rates of self-reported back or neck pain did not differ significantly between both study groups . Results show that sitting habits are more favourable in a " Moving school " . Further research is needed to study the impact of implementing " Moving school " concepts in traditional schools on sitting habits OBJECTIVE To study the relation between neck pain and work related neck flexion , neck rotation , and sitting . METHODS A prospect i ve cohort study was performed with a follow up of 3 years among 1334 workers from 34 companies . Work related physical load was assessed by analysing objective ly measured exposure data ( video recordings ) of neck flexion , neck rotation , and sitting posture . Neck pain was assessed by a question naire . Adjustments were made for various physical factors that were related or not related to work , psychosocial factors , and individual characteristics . RESULTS A significant positive relation was found between the percentage of the working time in a sitting position and neck pain , implying an increased risk of neck pain for workers who were sitting for more than 95 % of the working time ( crude relative risk ( RR ) 2.01 , 95 % confidence interval ( 95 % CI ) 1.04 to 3.88 ; adjusted RR 2.34 , 95 % CI 1.05 to 5.21 ) . A trend for a positive relation between neck flexion and neck pain was found , suggesting an increased risk of neck pain for people working with the neck at a minimum of 20 ° of flexion for more than 70 % of the working time ( crude RR 2.01 , 95 % CI 0.98 to 4.11 ; adjusted RR 1.63 , 95 % CI 0.70 to 3.82 ) . No clear relation was found between neck rotation and neck pain . CONCLUSION Sitting at work for more than 95 % of the working time seems to be a risk factor for neck pain and there is a trend for a positive relation between neck flexion and neck pain . No clear relation was found between neck rotation and neck pain & NA ; Little is known about the epidemiology of widespread pain ( WSP ) in children and adolescents . This study aims to estimate the new‐onset and prognosis of WSP in schoolchildren and investigate factors predicting its development . A prospect i ve study was conducted among 1756 schoolchildren ( age 10–12 years ) in Southern Finl and . At baseline , information was collected on WSP , regional musculoskeletal pain symptoms , depressiveness , fatigue , sleep problems , physical activity and joint hypermobility . These children were contacted again 1 year and 4 years later to determine the outcome and the new‐onset of WSP . A total of 1282 children ( 73 % ) of the baseline study population were found at both follow‐ups . Of the children who had WSP at baseline , 31 % and 30 % reported persistence/recurrence of symptoms at 1‐ and 4‐year follow‐up , respectively . However , only 10 % of these children reported WSP at both 1 and 4 years . Of the children who were free of WSP at baseline , 18 % reported new‐onset WSP at 1‐year follow‐up and 3 % reported these symptoms at both follow‐up times . The independent baseline risk factors of WSP were older age ( OR 1.3 95 % CI 1.0–1.8 ) , female gender ( OR 1.4 , 1.1–1.9 ) , depressiveness ( OR 1.5 , 1.1–2.2 ) and regional back pain symptoms ( Neck pain : OR 1.7 , 1.1–2.4 ; Upper back pain : OR 2.1 , 1.1–4.1 ; Lower back pain : OR 3.0 , 1.6–5.7 ) . Both psychological factors and somatic pain symptoms predict future development of WSP in adolescents & NA ; The aim of this longitudinal study was to assess changes with age regarding prevalence of pain and perceived health in a student population , as well as change over time at grade level . Pain included frequency of headache , abdominal , and musculoskeletal pain and perceived health included problems sleeping and /or if they often felt tired , lonely , and sad . If gender , age ( grade level ) , stress , physically activity were related to pain and health complaints were tested with multivariate logistic regression analysis . The students ( n = 1908 ) came from r and omly selected schools throughout Sweden and attended grade s 3 , 6 and 9 ( ages 9 , 12 and 15 at the onset of the year ) in 2001 . Three years later , 67 % ( n = 1276 ) of the same students answered a question naire that was constructed for the purpose of the studies . The responses given by the same students showed that girls ’ complaints of pain and perceived health increased with age and boys decreased . Over half ( 56 % ) of the girls and two‐thirds ( 67 % ) of the boys reported no frequent complaints either year . At grade level most variables were rated the same as three years earlier by the same age group . Stress was significantly related to pain and health complaints for girls and the risk of complaints , as calculated with odd OUTPUT: CONCLUSION There is unequivocal evidence that sitting and UQMP are related in children and adolescents . INPUT: The chair-side work posture of dental hygienists has long been a concern because of health-related problems potentially caused or exacerbated by poor posture . The purpose of this study was to investigate if using magnification loupes improved dental hygiene students ' posture during provision of treatment . The treatment chosen was h and -scaling , and the effect of the timing of introduction of the loupes to students was also examined . Thirty-five novice dental hygiene students took part in the study . Each student was assessed providing dental hygiene care with and without loupes , thus controlling for innate differences in natural posture . Students were r and omized into two groups . Group one used loupes in the first session and did not use them for the second session . Group two reversed this sequence . At the end of each session , all students were videotaped while performing scaling procedures . Their posture was assessed using an adapted version of Branson et al. 's Posture Assessment Instrument ( PAI ) . Four raters assessed students at three time periods for nine posture components on the PAI . A paired t-test compared scores with and without loupes for each student . Scores showed a significant improvement in posture when using loupes ( p<0.0001 ) , and these improvements were significantly more pronounced for students starting loupes immediately on entering the program compared with students who delayed until the second session ( p<0.1 ) . These results suggest a significant postural benefit is realized by requiring students to master the use of magnification loupes as early as possible within the curriculum Background Synthesis of multiple r and omized controlled trials ( RCTs ) in a systematic review can summarize the effects of individual outcomes and provide numerical answers about the effectiveness of interventions . Filtering of search es is time consuming , and no single method fulfills the principal requirements of speed with accuracy . Automation of systematic review s is driven by a necessity to expedite the availability of current best evidence for policy and clinical decision-making . We developed Rayyan ( http://rayyan.qcri.org ) , a free web and mobile app , that helps expedite the initial screening of abstract s and titles using a process of semi-automation while incorporating a high level of usability . For the beta testing phase , we used two published Cochrane review s in which included studies had been selected manually . Their search es , with 1030 records and 273 records , were uploaded to Rayyan . Different features of Rayyan were tested using these two review s. We also conducted a survey of Rayyan ’s users and collected feedback through a built-in feature . Results Pilot testing of Rayyan focused on usability , accuracy against manual methods , and the added value of the prediction feature . The “ taster ” review ( 273 records ) allowed a quick overview of Rayyan for early comments on usability . The second review ( 1030 records ) required several iterations to identify the previously identified 11 trials . The “ suggestions ” and “ hints , ” based on the “ prediction model , ” appeared as testing progressed beyond five included studies . Post rollout user experiences and a reflexive response by the developers enabled real-time modifications and improvements . The survey respondents reported 40 % average time savings when using Rayyan compared to others tools , with 34 % of the respondents reporting more than 50 % time savings . In addition , around 75 % of the respondents mentioned that screening and labeling studies as well as collaborating on review s to be the two most important features of Rayyan . As of November 2016 , Rayyan users exceed 2000 from over 60 countries conducting hundreds of review s totaling more than 1.6 M citations . Feedback from users , obtained mostly through the app web site and a recent survey , has highlighted the ease in exploration of search es , the time saved , and simplicity in sharing and comparing include-exclude decisions . The strongest features of the app , identified and reported in user feedback , were its ability to help in screening and collaboration as well as the time savings it affords to users . Conclusions Rayyan is responsive and intuitive in use with significant potential to lighten the load of review ers Background Work-related musculoskeletal disorders commonly experienced by dental professionals are one of the main occupational health problem affecting their health and well-being . This study was conducted to evaluate ergonomic factors and profession-related postures and also investigate relationship between demographic factors and work condition with pain in dental students . Material and Methods 60 freshman and sophomore dentistry students were r and omly chosen as the subjects of control group , and 60 of 5th and 6th-year students were selected as the members of exposure group . Data related to the subjects such as sex , doing exercise , severity of musculoskeletal pain were obtained through question naire . Students ’ postures were directly observed while treating patients and they were scored by REBA method . Data were analyzed by SPSS software using Man-Whitney , Kruskal-Wallis , Spearman and Kendall correlation tests . Results 80.8 % of the subjects were not aware of the correct ergonomic postures for dental procedures . Severity of musculoskeletal pain in the exposure group ( 15.9± 4.2 ) was significantly higher than the control group ( 10.5 ±3.2 ) , ( p < 0.001 ) . Risk of the most subjects ( 84 % ) was at the medium level . Students who were more involved in clinical activities experienced more muscular pains . Conclusions The musculoskeletal disorders are probable prolonged in working hours in static positions , incorrect work postures , implying more force and even tools and instruments . Therefore , students who are aware of ergonomic principals of their own profession would be able to maintain their health through activities and lifelong . Key words : Posture , dentistry , students , musculoskeletal pain OBJECTIVE To study the relation between neck pain and work related neck flexion , neck rotation , and sitting . METHODS A prospect i ve cohort study was performed with a follow up of 3 years among 1334 workers from 34 companies . Work related physical load was assessed by analysing objective ly measured exposure data ( video recordings ) of neck flexion , neck rotation , and sitting posture . Neck pain was assessed by a question naire . Adjustments were made OUTPUT:

CONCLUSIONS Based on a limited number of studies , the use of ergonomic saddle seats and dental loupes leads to improved working postures . The use of loupes appears to relieve shoulder , arm and h and pain . However , their effect on neck pain is scarce . None of the studies reported on the effect of the saddle seats on musculoskeletal pain .

MS2_dynamic_1_shot24

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Pain reduction can be achieved by lowering proinflammatory cytokine levels in the blood . Transcutaneous electrical nerve stimulation ( TENS ) is a non-invasive physiotherapeutic re source for pain management , but evidence on the effectiveness of this device at reducing proinflammatory cytokines in the blood is unclear . This study systematic ally review s the literature on the effect of TENS on proinflammatory cytokines . Methods A systematic review protocol was developed based on search es of articles in six electronic data bases and references of retrieved articles , contact with authors , and repositories of clinical trials . Eligibility criteria : publication in peer- review ed journals , r and omized clinical trials , use of TENS in the experimental group , and pre- and post- measurements of proinflammatory cytokines in the blood . Selection of the studies and extraction of the data will be carried out by two review ers independently . Characteristics of the study , participants , interventions and outcomes were extracted and described . Assessment s were performed on the risk of bias , level of evidence and the size of the intervention effect in the studies , according to GRADE guidelines and the Cochrane H and book for Systematic Review s. Clinical and statistical assessment s compared the effects of the interventions ( meta- analysis ) , taking into consideration any influencing characteristics of the studies ( e.g. , methods and application sites ) . Discussion We anticipate that this review will strengthen evidence -based knowledge of the effect of TENS on proinflammatory cytokines and , as a result , direct new studies to benefit patients with specific pathologies . Systematic review registration PROSPERO , CRD42017060379 Background : Chronic pelvic pain is prevalent in 2 % of women population globally . The etiology is multifactorial . Even in the absence of pelvic pathology , there is a subgroup of women who do not respond to analgesic and anti-inflammatory therapy . Chronic pelvic pain can be inhibited by direct inhibition of impulses in the preganglionic afferent neuron by closing the hypothetical gate in the dorsal horn of the spinal cord . Transcutaneous electrical nerve stimulation ( TENS ) is based on the gate control theory of abolishing the painful stimuli by providing simultaneous inputs in larger myelinated nerve fibers . Aims and Objectives : This study was design ed to assess the effectiveness and safety of TENS in idiopathic chronic pelvic pain . Methods : It is a prospect i ve , experimental study to evaluate the effectiveness of TENS versus placebo in reducing pain severity in chronic pelvic pain ( G1 = 30 , G2 = 32 , G3 = 30 , and G0 = 30 ) . Patients with chronic pelvic pain due to benign lesions of genital tract , gastrointestinal , and renal disorders were excluded from the study after performing an ultrasound study of abdomen and pelvis . Ten treatment sessions ( 5 sessions/week ) of 30 min were conducted . Observations and Results : There was a significant improvement in pain scores in TENS group as compared with control group , and two patients were completely pain free following TENS therapy . Conclusion : In women patients with idiopathic chronic pelvic pain , TENS can be a useful intervention . TENS units are safe , economical , and easily commercially available In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVE To observe the effect of transcutaneous acupoint electrical stimulation ( TAES ) on plasma ET , CGRP and serum IL-6 , S100beta during craniotomy . METHODS Fifty patients scheduled for neurosurgery were r and omly divided into TAES group ( n=25 ) and control group ( n=25 ) . TAES ( 2/100 Hz , 8 - 12 mA ) of bilateral Hegu ( LI 4)-Quchi ( LI 11 ) , Zusanli ( ST 36)-Sanyinjiao ( SP 6 ) was administrated for patients of TAES group starting 30 min before anesthesia till the end of the operation . Anesthesia of the patients was maintained with sevoflurane inhalation and intermittent intravenous injection of boluses of sulfenany and vecurnium bromide . Jugular venous blood sample s were taken at preanesthesia ( T0 ) , 1 hour after craniotomy ( T1 ) , closure complete ( T2 ) , 24 hours ( T3 ) and 48 hours ( T4 ) after operation respectively for detecting contents of plasma endothelin ( ET ) , calcitonin gene-related peptide ( CGRP ) and serum interleukin (IL)-6 , S100beta with radioimmunoassay and enzyme linked immunosorbent assay separately . RESULTS Compared with control group , plasma ET at T2 , serum IL-6 at T1 S100beta at T1 and T4 in TAES group all decreased significantly ( P < 0.01 , OUTPUT: It was observed through the meta- analysis synthesis measures that there were statistically significant differences following the use of TENS to reduce the general group of cytokines . When grouped by chronic disease , by postoperative setting s , or by individual studies in the case of IL-6 , it was observed that the significant reduction of cytokines related to the use of TENS was maintained . The use of TENS reduced the blood levels of proinflammatory cytokines ( we observed a protective factor of TENS in relation to inflammation ) . INPUT: Several authors have demonstrated the pivotal role of proinflammatory cytokines in inducing progressive cartilage degradation and secondary inflammation of the synovial membrane in osteoarthritis ( OA ) . It has recently been established that tumor necrosis factor (TNF)-alpha plays a well-defined role in the pathophysiology of inflammatory joint diseases and that binding to circulating soluble TNF-alpha receptors can inactivate it . We investigated the influence of mud pack treatment , which is able to diminish TNF-alpha serum values , on specific TNF receptor ( sTNF-R ) levels . Thirty-six patients with OA were enrolled and r and omized into two groups . Group A underwent mud pack treatment and group B underwent thermal bath treatment . A group of 20 healthy untreated subjects was used as a control . Blood sample s were collected at baseline and after treatment , and assays of sTNF-R55 and sTNF-R75 were performed in both groups . We found small changes in sTNF-Rs serum values but these were not statistically significant . sTNF-R55 serum values decreased by 0.4 % after the therapy in group A , while in group B the decrease was -17.7 % . sTNF-R75 was reduced by -21.17 % in group A and by -10.6 % in group B. In conclusion , through its thermic and ant/inflammatory activity mud pack treatment shows complex interaction with the most common factors of inflammatory and cartilage degradation . Our results suggest that the thermic component of this natural treatment is mainly involved in modulating inflammatory reaction and cartilage damage through binding of the circulating TNF , which controls the activation of the cells responsible for the production of proinflammatory cytokines OBJECTIVES To compare the differences or correlation between the results obtained from a generic and a disease-specific instrument for the study group and to assess the short-term effects of spa therapy on quality of life of patients with knee osteoarthritis . PATIENTS AND METHODS Fifty patients with knee osteoarthritis were r and omly recruited . They underwent a comprehensive spa therapy program for 21 days . Forty-six patients completed the study . The results were evaluated with Medical Outcomes Study 36-Item Short Form-36 ( SF-36 ) and Arthritis Impact Measurement Scale 2 ( AIMS 2 ) . RESULTS Statistically significant improvement was observed in all subscales of SF-36 . All subscales of AIMS 2 improved too , but only half of them were significant . Correlation between matching subscales of each test was also significant , except physical activity . CONCLUSION Comprehensive spa therapy seems to increase the quality of life of patients with knee osteoarthritis for short term Mud-bath therapy plays a primary role in the treatment and prevention of osteoarthritis that has been recognised since antiquity . Numerous studies have demonstrated its clinical benefits and its effects on inflammatory mediators ( interleukins ) , the immune system , cenesthesic factors ( endorphins ) , and the diencephalic – pituitary – adrenal axis . This study was conducted to assess the efficacy of mud-bath therapy with mineral water from the Sillene Spring at Italy ’s Chianciano Spa in patients with osteoarthritis of the knee . Patients ( n = 61 ) were divided into two groups . Group A underwent three cycles of mud-based spa therapy over a year ’s time , whereas group B did not . Clinical conditions , visual analogue scale pain ratings , and Lequesne indexes of the two groups were compared . We also compared these same parameters in the patients of the two groups that were following the therapy with drugs and in the patients of the group A before and after spa treatment . The percentage of patients with no symptoms or mild symptoms was higher in group A than in group B. Within group A , this percentage was higher after treatment than before spa therapy . Even in the comparison between the patients of the two groups that were following the therapy with drug , the results was that in group A the percentage of patients with no symptoms or mild symptoms was higher than in group B. Statistical analyses based on various tests revealed that almost all these differences were highly significant . No adverse effects were observed in any of the patients in group A. In conclusion , the mud-bath therapy performed at Chianciano Spa with Sillene Spring water remarkably improved the clinical conditions of patients with knee arthritis and significantly reduces the frequency and severity of symptoms and the disability they cause Mud pack therapy is an alternative mode of treatment for rheumatic diseases . It is based on the application of heated mud packs to the entire body or to specific areas , such as over joints . The aim of the current study was to evaluate the efficacy of treatment with mud compresses at patients ’ homes for osteoarthritis of the knee . Fifty-eight patients with osteoarthritis of the knee were enrolled in a prospect i ve , double-blinded , controlled study . Forty patients were treated with natural mineral-rich mud compresses and 18 patients were treated with mineral-depleted mud compresses . Mud compresses were applied 5 times each week during 3 weeks for a total of 15 treatments . Patients were assessed at baseline , at completion of the 3-week treatment period , and twice after the conclusion of the treatment period — after 1 month and after 3 months . The main outcome measures were the Lequesne Index of severity of knee osteoarthritis , patient self- assessment of pain , and severity of knee pain on a visual analog scale . A reduction of 20 % or more in the pain scores was considered clinical ly significant . In the group treated with natural mud compresses , a significant reduction in knee pain was observed at all assessment s. Similarly , improvement in the Lequesne Index was seen at the end of therapy and a month after treatment . In the control group , given mineral-depleted mud compresses , no significant change in knee pain was seen at any assessment . Improvement in the Lequesne Index was seen 1 OUTPUT:

CONCLUSION Mud pack therapy is considered an alternative and effective therapy in the clinical management of knee OA .

MS2_dynamic_1_shot25

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Epilepsy arises from an imbalance of inhibitory and excitatory influences in the brain . Vigabatrin ( VIG ) decreases the breakdown of the inhibitory neurotransmitter gamma-aminobutyric acid , whereas lamotrigine ( LTG ) reduces presynaptic excitatory amino acid release . 22 patients with refractory epilepsy , treated with an anticonvulsant regimen containing VIG , entered a balanced , double blind , placebo controlled , crossover trial of additional LTG . Treatment periods of 12 weeks ( 25 mg , 50 mg , 100 mg LTG twice daily for four weeks at each dose , and matched placebo ) were followed by wash out intervals of four weeks . 14 of the 20 patients completing the study improved , result ing in a significant fall in seizure days and numbers . Analysis of seizure type confirmed a beneficial effect on partial and secondary generalised tonic-clonic seizures . At the highest LTG dose ( 200 mg daily ) there was a median fall of 37 % in seizure count with nine ( 45 % ) patients reporting > 50 % reduction . Three of these patients were seizure free during this month of treatment . Side effects were minimal throughout the study . Concentrations of other antiepileptic drugs , including those of carbamazepine 10,11-epoxide , were not modified by LTG . This study suggests a substantial efficacy for a regimen containing VIG and LTG . Combinations of drugs with complementary modes of action may provide a rational pharmacological approach to the management of refractory epilepsy The efficacy of lamotrigine ( LTG ) , a new antiepileptic drug ( AED ) chemically unrelated to drugs in current use , was evaluated in 21 in- patients ( 18 males , 3 females ; mean age 34.6 ; range 23 - 42 years ) with severe refractory epilepsy . An add-on double-blind placebo-controlled crossover design was used , with 12 week treatment periods , and a 6 week washout period . Subjects were allocated to 1 of 2 dosing schedules according to their concomitant AEDs . Doses were increased according to clinical response . Although there was no significant reduction in total seizure count during the lamotrigine treatment period compared to placebo , there appears to be a drug effect as there was a marked reduction in generalized tonic-clonic seizures in favour of lamotrigine in the last 4 weeks of the treatment period . There was no significant difference in volunteered adverse experiences during active and placebo treatment . Concomitant serum AED concentrations , biochemical and haematological parameters were unaffected by lamotrigine treatment A double-blind , placebo-controlled trial is reported of lamotrigine as add-on treatment in therapy-resistant epilepsy . A within- patients serial design was used , with two 3-month treatment periods and an intervening 6-week washout/crossover period . An unblinded investigator adjusted lamotrigine dosage to achieve a plasma concentration within a previously predicted therapeutic range . All patients had therapy-resistant partial seizures , some in combination with other seizure types and were without serious neurological or intellectual deficit . Of 34 patients recruited only one was withdrawn because of an adverse experience ( maculo-papular rash ) probably related to the experimental drug and 30 completed the trial . The other 3 withdrawals were due to default during baseline , dispensing error and cholecystectomy . There was a modest statistically significant reduction in total and partial seizures on lamotrigine compared to placebo treatment . There was no difference in adverse experiences or abnormal biochemical or haematological findings between the lamotrigine and placebo periods . The plasma concentrations of concomitantly administered antiepileptic drugs were not affected by lamotrigine treatment . It is concluded that lamotrigine shows promise as an antiepileptic drug with low toxicity The antiepileptic effect of lamotrigine ( Lamictal ® ) was assessed in a double‐blind , placebo‐controlled , crossover trial in 56 adult patients with refractory partial seizures . Lamotrigine or placebo was added to the patients ' existing antiepileptic drugs ( AEDs ) . The dose of lamotrigine varied from 75 to 400 mg daily . Thirty‐eight patients completed the trial and 7 withdrew because of adverse experiences . There was a statistically significant reduction in seizure counts on lamotrigine compared with placebo for total seizures ( 30.3 % reduction , 95 % CI 8.4 % , 47.0 % ) , complex partial seizures ( 29.2.% reduction , 95 % CI 3.8 % , 47.9 % ) and secondary generalised seizures ( 37.9 % , CI 18.9 % , 52.4 % ) . The analysis of total seizure days showed a similar significant reduction during lamotrigine treatment for the same seizure categories . There was no statistically significant difference in reporting of adverse events between lamotrigine and placebo except for dizziness which was reported more frequently on lamotrigine than on placebo . There were no differences in abnormal haematological or biochemical findings between lamotrigine and placebo , and lamotrigine had no effect on plasma concentrations of concomitant AEDs Remission of seizures is a crucial measure of outcome in epilepsy . The National General Practice Study of Epilepsy ( NGPSE ) aim ed to investigate the remission of patients with epilepsy and the effect of various factors on the likelihood of remission . The NGPSE is a prospect i ve population -based study free from major selection bias . We enrolled 1091 patients with newly diagnosed or suspected epilepsy who attended one of OUTPUT: REVIEW ER 'S CONCLUSIONS Lamotrigine add-on therapy is effective in reducing the seizure frequency , in patients with drug-resistant partial epilepsy . INPUT: There is a pressing need for additional treatment options for refractory mood disorders . This controlled comparative study evaluated the efficacy of lamotrigine ( LTG ) and gabapentin ( GBP ) monotherapy versus placebo ( PLC ) . Thirty-one patients with refractory bipolar and unipolar mood disorders participated in a double-blind , r and omized , crossover series of three 6-week monotherapy evaluations including LTG , GBP , and PLC . There was a st and ardized blinded titration to assess clinical efficacy or to determine the maximum tolerated daily dose ( LTG 500 mg or GBP 4,800 mg ) . The primary outcome measure was the Clinical Global Impressions Scale ( CGI ) for Bipolar Illness as supplemented by other st and ard rating instruments . The mean doses at week 6 were 274 + /- 128 mg for LTG and 3,987 + /- 856 mg for GBP . Response rates ( CGI ratings of much or very much improved ) were the following : LTG , 52 % ( 16/31 ) ; GBP , 26 % ( 8/31 ) ; and PLC , 23 % ( 7/31 ) ( Cochran 's Q = 6.952 , df = 2 , N = 31 , p = 0.031 ) . Post hoc Q differences ( df = 1 , N = 31 ) were the following : LTG versus GBP ( Qdiff = 5.33 , p = 0.011 ) ; LTG versus PLC ( Qdiff = 4.76 , p = 0.022 ) ; and GBP versus PLC ( Qdiff = 0.08 , p = 0.70 ) . With respect to anticonvulsant dose and gender , there was no difference between the responders and the nonresponders . The agents were generally well tolerated . This controlled investigation preliminarily suggests the efficacy of LTG in treatment-refractory affectively ill patients . Further definition of responsive subtypes and the role of these medications in the treatment of mood disorders requires additional study OBJECTIVE To determine the efficacy of divalproex ( extended release ) in the treatment of acute nonrefractory bipolar depression . METHOD In a stratified , double-blind , r and omized , placebo-controlled trial , 18 acutely depressed bipolar out patients ( DSM-IV criteria ) received either divalproex monotherapy ( target dose level , 70 - 90 ng/dL ) ( N = 9 ) or placebo ( N = 9 ) for 6 weeks . Patients were recruited between January 2004 and May 2005 . Clinical assessment on the Montgomery-Asberg Depression Rating Scale ( MADRS ) determined primary efficacy . RESULTS The divalproex treatment group showed significantly greater reduction in MADRS scores compared to placebo ( group x time interaction , p = .0078 ) . Absolute effect size of estimated MADRS total score reduction over time was 13.6 points with divalproex versus 1.4 points with placebo ( p = .003 , linear growth curve model ) . St and ardized effect size was large ( Cohen d = 0.81 ) . MADRS item analyses demonstrated improvement in core mood symptoms more than in anxiety or insomnia symptoms . There was also a modest but significant association between MADRS and Mania Rating Scale scores in the divalproex group ( r = 0.29 , df = 51 , p = .03 ) , but not in the placebo group ( r = -0.15 , df = 35 , p = .36 ) . CONCLUSIONS Divalproex appeared to be an effective treatment for acute nonrefractory bipolar depression , which is consistent with previous small r and omized studies . Some evidence of benefit in the depressive mixed state was observed . Confirmation or refutation with larger r and omized clinical trials is warranted . CLINICAL TRIAL REGISTRATION Clinical Trials.gov identifier NCT00226343 BACKGROUND To our knowledge , this is the first prospect i ve natural history study of weekly symptomatic status of patients with bipolar I disorder ( BP-I ) during long-term follow-up . METHODS Analyses are based on ongoing prospect i ve follow-up of 146 patients with Research Diagnostic Criteria BP-I , who entered the National Institute of Mental Health ( Bethesda , Md ) Collaborative Depression Study from 1978 through 1981 . Weekly affective symptom status ratings were analyzed by polarity and severity , ranging from asymptomatic , to subthreshold levels , to full-blown major depression and mania . Percentages of follow-up weeks at each level as well as number of shifts in symptom status and polarity during the entire follow-up period were examined . Finally , 2 new measures of chronicity were evaluated in relation to previously identified predictors of chronicity for BP-I. RESULTS Patients with BP-I were symptomatically ill 47.3 % of weeks throughout a mean of 12.8 years of follow-up . Depressive symptoms ( 31.9 % of total follow-up weeks ) predominated over manic/hypomanic symptoms ( 8.9 % of weeks ) or cycling/mixed symptoms ( 5.9 % of weeks ) . Subsyndromal , minor depressive , and hypomanic symptoms combined were nearly 3 times more frequent than syndromal-level major depressive and manic symptoms ( 29.9 % vs 11.2 % of weeks , respectively ) . Patients with BP-I changed symptom status an average of 6 times per year and polarity more than 3 times per year . Longer intake episodes and those with depression-only or cycling polarity predicted greater chronicity during long-term follow-up , as did comorbid drug- OUTPUT:

Findings were inconclusive for lamotrigine and carbamazepine although overall lamotrigine may have a beneficial but modest effect . Negative results were found for levetiracetam and gabapentin but the evidence base on these agents is scant . All anticonvulsants were generally well tolerated . No double-blind RCTs were found for the use of other anticonvulsants such as oxcarbazepine , licarbazepine , zonisamide , retigabine , pregabalin , tiagabine , felbamate and vigabatrine in the acute treatment of bipolar depression . To sum up , taking into consideration the efficacy and tolerability profiles of anticonvulsants , current evidence supports the use of divalproex and lamotrigine in the treatment of acute bipolar depression .

MS2_dynamic_1_shot26

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Hypercholesterolemia is a major risk factor for cardiovascular disease . Not all patients respond well to traditional cholesterol lowering medications . Probiotics have been evaluated for their cholesterol-lowering effects in humans with variable results . This study was performed to evaluate the efficacy of two probiotics in lowering the serum cholesterol of hypercholesterolemic patients . MATERIAL S AND METHODS A r and omized double-blind controlled trial was conducted comparing placebo to Lactobacillus acidophilus plus Bifidobacterium bifidum in patients diagnosed with hypercholesterolemia . Placebo or probiotic capsules were taken three times daily for six weeks . Pre- and post-treatment total cholesterol ( TC ) , HDL-cholesterol ( HDL-C ) , LDL-cholesterol ( LDL-C ) and triglyceride ( TG ) levels and demographic parameters of the two groups were compared . From a total of 70 participants , 64 completed the assigned treatment ( 31 in probiotics group and 33 in the control group).The two treatment groups were matched for age , sex , weight , height , BMI , waist and hip circumferences , and blood pressure . RESULTS Baseline evaluation revealed no difference between the probiotics group and control group levels of TC , HDL-C , LDL-C and TG . TC levels in the probiotics group decreased during treatment ( 237.2 vs. 212.7 mg/dL , p<0.05 ) . TC and LDL-C levels in the control group increased significantly from their baseline levels during treatment . TC ( 212.7 vs 252.8 mg/dL , p<0.001 ) , HDL-C ( 52.0 vs 59.1 mg/dL , p=0.04 ) and LDL-C ( 153.9 vs 182.1 mg/dL , p<0.01 ) levels in the probiotics group were significantly lower at the end of treatment than the corresponding levels in the control group . CONCLUSION A combination of Lactobacillus acidophilus and Bifidobacterium bifidum decreased serum total cholesterol , LDL-cholesterol and HDL-cholesterol levels in hypercholesterolemic patients over a six week period . There was no effect on serum triglyceride or fasting blood glucose levels BACKGROUND The short-chain fatty acids formed in the human colon by the bacterial fermentation of fiber may have an antiinflammatory effect , may reduce insulin production , and may improve lipid metabolism . We previously showed in hypercholesterolemic patients that supplementation with the probiotic bacteria Lactobacillus plantarum 299v significantly lowers concentrations of LDL cholesterol and fibrinogen . OBJECTIVE We determined the influence of a functional food product containing L. plantarum 299v on lipid profiles , inflammatory markers , and monocyte function in heavy smokers . DESIGN Thirty-six healthy volunteers ( 18 women and 18 men ) aged 35 - 45 y participated in a controlled , r and omized , double-blind trial . The experimental group drank 400 mL/d of a rose-hip drink containing L. plantarum 299v ( 5 x 10(7 ) colony-forming units/mL ) ; the control group consumed the same volume of product without bacteria . The experiment lasted 6 wk and entailed no changes in lifestyle . RESULTS Significant decreases in systolic blood pressure ( P < 0.000 ) , leptin ( P < 0.000 ) , and fibrinogen ( P < 0.001 ) were recorded in the experimental group . No such changes were observed in the control group . Decreases in F(2)-isoprostanes ( 37 % ) and interleukin 6 ( 42 % ) were also noted in the experimental group in comparison with baseline . Monocytes isolated from subjects treated with L. plantarum showed significantly reduced adhesion ( P < 0.001 ) to native and stimulated human umbilical vein endothelial cells . CONCLUSION L. plantarum administration leads to a reduction in cardiovascular disease risk factors and could be useful as a protective agent in the primary prevention of atherosclerosis in smokers Aim Evidence of a possible connection between gut microbiota and several physiological processes linked to type 2 diabetes is increasing . However , the effect of multi-strain probiotics in people with type 2 diabetes remains unclear . This study investigated the effect of multi-strain microbial cell preparation — also refers to multi-strain probiotics — on glycemic control and other diabetes-related outcomes in people with type 2 diabetes . Design A r and omized , double-blind , parallel-group , controlled clinical trial . Setting Diabetes clinic of a teaching hospital in Kuala Lumpur , Malaysia . Participants A total of 136 participants with type 2 diabetes , aged 30–70 years , were recruited and r and omly assigned to receive either probiotics ( n = 68 ) or placebo ( n = 68 ) for 12 weeks . Outcomes Primary outcomes were glycemic control-related parameters , and secondary outcomes were anthropomorphic variables , lipid profile , blood pressure and high-sensitivity C-reactive protein . The Lactobacillus and Bifidobacterium quantities were measured before and after intervention as an indicator of successful passage of the supplement through gastrointestinal tract . Statistical analysis Intention-to-treat ( ITT ) analysis was performed on all participants , while per- protocol ( PP ) analysis was performed on those participants who had successfully completed the trial with good compliance rate . Results With respect to primary outcomes , glycated hemoglobin decreased by 0.14 % in the probiotics and increased by 0 OUTPUT: Our meta- analysis showed a modest but a significant reduction in SBP and DBP in patients with hypertension , particularly in those with diabetes mellitus , following probiotic supplementation . This effect was associated with treatment duration , dosage , and the age of subject but was not associated with single or multiple strains usage . Additionally , probiotic supplement had a beneficial effect in reducing BMI and blood glucose INPUT: Cassia tora fiber supplement consisting of 2 g of soluble fiber extracted from Cassia semen ( C. tora L. ) , 200 mg of alpha-tocopherol , 500 mg of ascorbic acid , and 300 mg of maltodextrin was formulated in a pack , and given to 15 type II diabetic subjects ( seven men and eight women 57.1 + /- 2.9 years old ) with instructions to take two packs per day for 2 months . Placebo contained maltodextrin only with a little brown caramel color . Lifestyle factors and dietary intakes of the subjects were not altered during the 2-month period . Serum total cholesterol was moderately ( P < .1 ) decreased in the C. tora group compared with the age- and gender-matched placebo group , as was the ratio of apolipoprotein B to apolipoprotein A1 ( P < .1 ) . Levels of serum triglycerides and low-density lipoprotein-cholesterol tended to decrease more in the C. tora-supplemented group than in the placebo group . Serum alpha-tocopherol was increased ( P < .01 ) but lipid peroxides were not significantly lower in the C. tora group . Fasting blood glucose , hemoglobin A1c , blood urea nitrogen , creatinine , and activities of serum aspartate aminotransferase and alanine aminotransferase were not changed by the fiber supplement . We concluded that C. tora supplements can help improve serum lipid status in type II diabetic subjects without serious adverse effects Background : To reach fetal appropriate growth during the third trimester , the requirements for dietary calcium and iron intakes during the pregnancy increases . This study was carried out to determine the effects of daily consumption of probiotic yoghurt on serum calcium and iron levels and liver enzymes among Iranian healthy pregnant women . Methods : In this controlled clinical trial , 70 primigravida pregnant women carrying singleton pregnancy at their third trimester were participated . Participants were r and omly divided into two groups of consuming 200 g/d of conventional ( n = 33 ) or probiotic yogurts ( n = 37 ) for 9 weeks . The probiotic yogurt contained Lactobacillus acidophilus and Bifidobacterium lactis with a total of min 1 × 107 CFU . To measure serum calcium , iron , aspartate aminotransferase ( AST ) and alanine aminotransferase ( ALT ) levels , blood sample s were drawn in a fasting state at baseline and after 9 weeks intervention . Results : Consumption of probiotic yogurt result ed in maintaining serum calcium levels compared with the conventional yogurt ( P = 0.01 ) . Within-group differences in the conventional yogurt group revealed a significant reduction of serum calcium levels ( −1.7 mg/dL , P < 0.0001 ) . No significant differences were found between the two yogurts in terms of their effects on serum iron , AST and ALT levels . Conclusions : Consumption of probiotic yogurt among pregnant women result ed in maintaining serum calcium levels compared with the conventional yogurt ; however , it could not affect serum iron , ALT and AST levels This study aim ed to evaluate the relationship between gut probiotic flora and nonalcoholic fatty liver disease in a diet-induced rat model , and to compare the effects of two different probiotic strains on nonalcoholic fatty liver disease . Forty male Sprague-Dawley rats were r and omized into 4 groups for 12 weeks : control ( st and ard rat chow ) , model ( fat-rich diet ) , Lactobacillus ( fat-rich diet plus Lactobacillus acidophilus ) , and Bifidobacterium ( fat-rich diet plus Bifidobacterium longum ) groups . Probiotics were provided to rats in drinking water ( 1010/ml ) . Gut bifidobacteria and lactobacilli were obviously lower at weeks 8 and 10 , respectively , in the model group compared with the control group . Supplementation with Bifidobacterium significantly attenuated hepatic fat accumulation ( 0.10 ± 0.03 g/g liver tissue ) compared with the model group ( 0.16 ± 0.03 g/g liver tissue ) . However , there was no improvement in intestinal permeability in either the Lactobacillus or the Bifidobacterium group compared with the model group . In all 40 rats , the hepatic total lipid content was negatively correlated with gut Lactobacillus ( r = −0.623 , p = 0.004 ) and Bifidobacterium ( r = −0.591 , p = 0.008 ) . Oral supplementation with probiotics attenuates hepatic fat accumulation . Further , Bifidobacterium longum is superior in terms of attenuating liver fat accumulation than is Lactobacillus acidophilus Background The beneficial effect of probiotics on renal profile and liver function has been reported among patients with chronic kidney disease and fatty liver respectively . However , its effect on renal profile and liver function among type 2 diabetic individuals has not been fully understood . To investigate the effect of microbial cell preparation on renal profile and liver function tests among type 2 diabetic individuals . Methods A r and omized , double-blind , parallel-group , controlled clinical trial was conducted on a total of 136 type 2 diabetics age 30 - 70 years old in a teaching hospital in Kuala Lumpur , Malaysia . Subjects were r and omly assigned to receive microbial cell preparation ( N = 68 ) or a placebo ( N = 68 ) for 12 weeks . The outcomes measured at baseline OUTPUT:

Conclusion This meta- analysis supports the potential use of microbial therapies in the treatment of NAFLD and sheds light on their potential mode of action .

MS2_dynamic_1_shot27

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives . The prevalence of type 2 diabetes in American adolescents has increased markedly during the past generation . Although the factors that contribute to the development of type 2 diabetes are complex and not wholly eluci date d , the triad of severe obesity , hyperinsulinemia , and a family history of type 2 diabetes places a child at an increased risk for development of the disease . Current approaches to the prevention of type 2 diabetes , including dietary counseling and exercise , have had limited success . We reasoned that drugs that increase glucose tolerance in diabetic patients might prove useful in preventing the progression to glucose intolerance in high-risk patients . To that end , we conducted a double-blind , placebo-controlled study of the effects of metformin on body mass index ( BMI ) , serum leptin , glucose tolerance , and serum lipids in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes . Methods . The study population consisted of 29 white and black adolescents aged 12 to 19 years . All had BMI s exceeding 30 kg/m2 . Criteria for enrollment included : 1 ) a fasting insulin concentration exceeding 15 μU/mL ; and 2 ) at least 1 first- or second-degree relative with type 2 diabetes . All patients had fasting plasma glucose concentrations < 110 mg% and hemoglobin A1c concentrations ≤6.0 % . All had normal linear growth and sexual development for age , with no marked hirsutism , severe acne , or menstrual irregularities characteristic of polycystic ovary syndrome . Eight participants had acanthosis nigricans . After baseline laboratory studies including a rapidly sample d intravenous glucose tolerance test , patients were r and omized to receive metformin ( 500 mg twice daily ) or a placebo for a total of 6 months . The effects of metformin on BMI st and ard deviation score , serum leptin , glucose tolerance , and serum lipids were analyzed . The study was double-blinded and included no specific dietary restrictions . Results . Metformin caused a decline of 0.12 st and ard deviation in BMI in study participants ( −1.3 % from baseline ) , and a 5.5 % reduction in serum leptin in girls . In contrast , BMI and serum leptin rose 0.23 st and ard deviation ( 2.3 % ) and 16.2 % , respectively , in the placebo group during the treatment period . Metformin caused a progressive decline in fasting blood glucose ( from a mean of 84.9 to 75.1 mg% ) and a reduction in fasting insulin levels ( from 31.3 to 19.3 μU/mL ) . In contrast , fasting glucose levels in the placebo group rose slightly from 77.2 to 82.3 mg% , and fasting insulin levels did not change . Insulin sensitivity , as assessed by the ratio of fasting insulin to glucose concentrations and the quantitative insulin sensitivity check index ( 1/[log fasting insulin + log fasting glucose ] ) and homeostasis model assessment insulin resistance index ( fasting insulin × fasting glucose/22.5 ) indices , increased slightly in the metformin-treated participants . However , the insulin sensitivity measured using Bergman 's minimal model did not change . There were also no significant changes in glucose effectiveness , hemoglobin A1c , serum lipids , or serum lactate in the metformin or placebo groups . Metformin was tolerated well by the majority of patients . Transient abdominal discomfort or diarrhea occurred in 40 % of treated participants ; there were no episodes of vomiting or lactic acidosis . Conclusions . The treatment of obesity and insulin resistance in adults often proves ineffective because the vicious cycle leading to type 2 diabetes may have become entrenched and , to some extent , may be irreversible . Early detection and therapy of the obese adolescent with a family history of type 2 diabetes may interrupt the cycle of weight gain and insulin resistance that leads to glucose intolerance in adulthood . Through its ability to reduce fasting blood glucose and insulin concentrations and to moderate weight gain , metformin might complement the effects of dietary and exercise counseling and reduce the risk of type 2 diabetes in selected patients Insulin resistance plays an important role in the pathophysiology of diabetes and is associated with obesity and other cardiovascular risk factors . The " gold st and ard " glucose clamp and minimal model analysis are two established methods for determining insulin sensitivity in vivo , but neither is easily implemented in large studies . Thus , it is of interest to develop a simple , accurate method for assessing insulin sensitivity that is useful for clinical investigations . We performed both hyperinsulinemic isoglycemic glucose clamp and insulin-modified frequently sample d iv glucose tolerance tests on 28 nonobese , 13 obese , and 15 type 2 diabetic subjects . We obtained correlations between indexes of insulin sensitivity from glucose clamp studies ( SI(Clamp ) ) and minimal model analysis ( SI(MM ) ) that were comparable to previous reports ( r = 0.57 ) . We performed a sensitivity analysis on our data and discovered that physiological steady state values [ i.e. fasting insulin ( I(0 ) ) and glucose ( G(0 ) ) ] contain critical information about insulin sensitivity . We defined a quantitative insulin sensitivity check index ( QUICKI = 1/[log(I(0 ) ) + log(G(0 ) ) ] ) that has substantially better correlation with SI(Clamp ) ( r = 0.78 ) than the correlation we observed between SI(MM ) and SI(Clamp ) . Moreover , we observed a comparable overall OUTPUT: Conclusions : Short-term metformin treatment appears to moderately affect weight reduction in severely obese children and adolescents , with a concomitant improvement in fasting insulin sensitivity . INPUT: Objectives . The prevalence of type 2 diabetes in American adolescents has increased markedly during the past generation . Although the factors that contribute to the development of type 2 diabetes are complex and not wholly eluci date d , the triad of severe obesity , hyperinsulinemia , and a family history of type 2 diabetes places a child at an increased risk for development of the disease . Current approaches to the prevention of type 2 diabetes , including dietary counseling and exercise , have had limited success . We reasoned that drugs that increase glucose tolerance in diabetic patients might prove useful in preventing the progression to glucose intolerance in high-risk patients . To that end , we conducted a double-blind , placebo-controlled study of the effects of metformin on body mass index ( BMI ) , serum leptin , glucose tolerance , and serum lipids in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes . Methods . The study population consisted of 29 white and black adolescents aged 12 to 19 years . All had BMI s exceeding 30 kg/m2 . Criteria for enrollment included : 1 ) a fasting insulin concentration exceeding 15 μU/mL ; and 2 ) at least 1 first- or second-degree relative with type 2 diabetes . All patients had fasting plasma glucose concentrations < 110 mg% and hemoglobin A1c concentrations ≤6.0 % . All had normal linear growth and sexual development for age , with no marked hirsutism , severe acne , or menstrual irregularities characteristic of polycystic ovary syndrome . Eight participants had acanthosis nigricans . After baseline laboratory studies including a rapidly sample d intravenous glucose tolerance test , patients were r and omized to receive metformin ( 500 mg twice daily ) or a placebo for a total of 6 months . The effects of metformin on BMI st and ard deviation score , serum leptin , glucose tolerance , and serum lipids were analyzed . The study was double-blinded and included no specific dietary restrictions . Results . Metformin caused a decline of 0.12 st and ard deviation in BMI in study participants ( −1.3 % from baseline ) , and a 5.5 % reduction in serum leptin in girls . In contrast , BMI and serum leptin rose 0.23 st and ard deviation ( 2.3 % ) and 16.2 % , respectively , in the placebo group during the treatment period . Metformin caused a progressive decline in fasting blood glucose ( from a mean of 84.9 to 75.1 mg% ) and a reduction in fasting insulin levels ( from 31.3 to 19.3 μU/mL ) . In contrast , fasting glucose levels in the placebo group rose slightly from 77.2 to 82.3 mg% , and fasting insulin levels did not change . Insulin sensitivity , as assessed by the ratio of fasting insulin to glucose concentrations and the quantitative insulin sensitivity check index ( 1/[log fasting insulin + log fasting glucose ] ) and homeostasis model assessment insulin resistance index ( fasting insulin × fasting glucose/22.5 ) indices , increased slightly in the metformin-treated participants . However , the insulin sensitivity measured using Bergman 's minimal model did not change . There were also no significant changes in glucose effectiveness , hemoglobin A1c , serum lipids , or serum lactate in the metformin or placebo groups . Metformin was tolerated well by the majority of patients . Transient abdominal discomfort or diarrhea occurred in 40 % of treated participants ; there were no episodes of vomiting or lactic acidosis . Conclusions . The treatment of obesity and insulin resistance in adults often proves ineffective because the vicious cycle leading to type 2 diabetes may have become entrenched and , to some extent , may be irreversible . Early detection and therapy of the obese adolescent with a family history of type 2 diabetes may interrupt the cycle of weight gain and insulin resistance that leads to glucose intolerance in adulthood . Through its ability to reduce fasting blood glucose and insulin concentrations and to moderate weight gain , metformin might complement the effects of dietary and exercise counseling and reduce the risk of type 2 diabetes in selected patients OBJECTIVE The management of obesity , apart from exercise , mainly involves a calorie restriction regimen . A pharmaceutical treatment is often used to improve patient compliance and diet effectiveness , although several side-effects have previously been described . To improve patient compliance and diet effectiveness without incurring unpleasant side-effects , we evaluated whether a distracting mini-meal can physiologically decrease the absorption of fats and carbohydrates . DESIGN Two minutes before each of the three meals consumed daily , 32 obese patients were treated with a distracting mini-meal , 32 with metformin , and 32 with placebo . At baseline and after 1 , 3 , and 6 months of treatment , body weight , body mass index , waist circumference , fasting/post-pr and ial insulinaemia and glycaemia , homeostasis model assessment -index , triacylglycerols , and total cholesterol were evaluated . RESULTS All patients showed good compliance . With the exception of post-pr and ial glycaemia , a significant reduction in all parameters was documented in every group , albeit the greater variation was observed in patients treated with a distracting mini-meal or metformin . No one showed noteworthy side-effects . CONCLUSIONS Our study focuses on a distracting mini-meal that could become a useful tool in enhancing weight loss . The beneficial effect of a distracting meal on insulin resistance , glucose , and lipid metabolism suggest OUTPUT:

Network meta- analysis revealed that in adolescents , intervention with 2000 mg/day metformin ranked better than other interventions ; however , 1000 mg/day metformin for 3 months may be most suitable for adolescents . For adults , metformin at doses of 3000 and 1000 mg/day ranked the highest , other than minimeal and lifestyle interventions ; moreover , intervention with 3000 mg/day for 6 months and 1000 mg/day for 0.5 months may be suitable for adults . Conclusion When considering the efficacy of interventions for losing weight , metformin offers clear advantages for overweight and obese population

MS2_dynamic_1_shot28

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Abstract Objective To assess the effectiveness of a targeted , multiple intervention falls prevention programme in reducing falls and injuries related to falls in a subacute hospital . Design R and omised controlled trial of a targeted multiple intervention programme implemented in addition to usual care compared with usual care alone . Setting Three subacute wards in a metropolitan hospital specialising in rehabilitation and care of elderly patients . Participants 626 men and women aged 38 to 99 years ( average 80 years ) were recruited from consecutive admissions to subacute hospital wards . Intervention Falls risk alert card with information brochure , exercise programme , education programme , and hip protectors . Main outcome measures Incidence rate of falls , injuries related to falls , and proportion of participants who experienced one or more falls during their stay in hospital . Results Participants in the intervention group ( n = 310 ) experienced 30 % fewer falls than participants in the control group ( n = 316 ) . This difference was significant ( Peto log rank test P = 0.045 ) and was most obvious after 45 days of observation . In the intervention group there was a trend for a reduction in the proportion of participants who experienced falls ( relative risk 0.78 , 95 % confidence interval 0.56 to 1.06 ) and 28 % fewer falls result ed in injury ( log rank test P = 0.20 ) . Conclusions A targeted multiple intervention falls prevention programme reduces the incidence of falls in the subacute hospital setting Objective To determine the efficacy of a targeted multifactorial falls prevention programme in elderly care wards with relatively short lengths of stay . Design Cluster r and omised trial . Setting 24 elderly care wards in 12 hospitals in Sydney , Australia . Participants 3999 patients , mean age 79 years , with a median hospital stay of seven days . Interventions A nurse and physiotherapist each worked for 25 hours a week for three months in all intervention wards . They provided a targeted multifactorial intervention that included a risk assessment of falls , staff and patient education , drug review , modification of bedside and ward environments , an exercise programme , and alarms for selected patients . Main outcome measure Falls during hospital stay . Results Intervention and control wards were similar at baseline for previous rates of falls and individual patient characteristics . Overall , 381 falls occurred during the study . No difference was found in fall rates during follow-up between intervention and control wards : respectively , 9.26 falls per 1000 bed days and 9.20 falls per 1000 bed days ( P=0.96 ) . The incidence rate ratio adjusted for individual lengths of stay and previous fall rates in the ward was 0.96 ( 95 % confidence interval 0.72 to 1.28 ) . Conclusion A targeted multifactorial falls prevention programme was not effective among older people in hospital wards with relatively short lengths of stay . Trial registration Australian New Zeal and Clinical Trials Registry ACTRNO 12605000467639 Background Patients in hospitals and nursing homes are at risk of the development of , often preventable , adverse events ( AEs ) , which threaten patient safety . Guidelines for prevention of many types of AEs are available , however , compliance with these guidelines appears to be lacking . Besides general barriers that inhibit implementation , this non-compliance is associated with the large number of guidelines competing for attention . As implementation of a guideline is time-consuming , it is difficult for organisations to implement all available guidelines . Another problem is lack of feedback about performance using quality indicators of guideline based care and lack of a recognisable , unambiguous system for implementation . A program that allows organisations to implement multiple guidelines simultaneously may facilitate guideline use and thus improve patient safety . The aim of this study is to develop and test such an integral patient safety program that addresses several AEs simultaneously in hospitals and nursing homes . This paper reports the design of this study . Methods and design The patient safety program addresses three AEs : pressure ulcers , falls and urinary tract infections . It consists of bundles and outcome and process indicators based on the existing evidence based guidelines . In addition it includes a multifaceted tailored implementation strategy : education , patient involvement , and a computerized registration and feedback system . The patient safety program was tested in a cluster r and omised trial on ten hospital wards and ten nursing home wards . The baseline period was three months followed by the implementation of the patient safety program for fourteen months . Subsequently the follow-up period was nine months . Primary outcome measure was the incidence of AEs on every ward . Secondary outcome measures were the utilization of preventive interventions and the knowledge of nurses regarding the three topics . R and omisation took place on ward level . The results will be analysed separately for hospitals and nursing homes . Discussion Major challenges were the development of the patient safety program including a digital registration and feedback system and the implementation of the patient safety program . Trial registration Trial registration : Clinical Trials.gov ID [ NCT00365430 Abstract Objectives : To identify clinical characteristics of elderly in patients that predict their chance of falling ( phase 1 ) and to use these characteristics to derive a risk assessment tool and to evaluate its power in predicting falls ( phases 2 and 3 ) . Design : Phase 1 : a prospect i ve case-control study . Phases 2 and 3 : prospect i ve evaluations of the derived risk assessment tool in predicting falls in two cohorts . Setting : Elderly care units of St Thomas 's Hospital ( phase 1 and 2 ) and Kent and Canterbury Hospital ( phase 3 ) . Subjects : Elderly hospital in patients ( aged 65 years ) : 116 cases and 116 controls in phase 1 , 217 patients in phase 2 , and 331 in phase 3 . Main outcome measures : 21 separate clinical characteristics were assessed in phase 1 , including the abbreviated mental test score , modified Barthel index , a transfer and mobility score obtained by combining the transfer and mobility sections of the Barthel index , and several nursing judgments . Results : In phase 1 five factors were independently associated with a higher OUTPUT: Harms were not systematic ally examined , but potential harms included increased use of restraints and sedating drugs and decreased efforts to mobilize patients . INPUT: OBJECTIVES To investigate the predictive validity and reliability of the STRATIFY falls risk assessment tool as applied to patients recovering from acute stroke . DESIGN Prospect i ve cohort study . SETTING Six stroke rehabilitation units in the North of Engl and . SUBJECTS All patients with a diagnosis of acute stroke admitted to the participating stroke units during a 6-month study period . ASSESSMENT on admission , falls risk ( STRATIFY ) , disability ( Barthel index ) , mobility ( Rivermead mobility index ) , cognitive impairment ( abbreviated mental test score ) and visual neglect ( Albert 's test ) were assessed . Then , STRATIFY was completed weekly and within 48 h of anticipated discharge . Consenting patients were contacted at 3 months after discharge to determine falls . OUTCOME MEASURES Occurrence of a fall within 28 days of the baseline STRATIFY ( in-patient study ) , falls in the first 3 months after discharge ( post-discharge study ) and falls during stroke unit stay ( reliability study ) . RESULTS From 387 patients admitted to the participating units during the study period , 225 contributed to the 28 day in-patient study , and 234 were followed up at 3 months after discharge . STRATIFY performed poorly in predicting falls in the first 28 days ( sensitivity 11.3 % and specificity 89.5 % ) and after discharge ( sensitivity 16.3 % and specificity 86.4 % ) . Agreement was ' fair ' between baseline and discharge scores ( kappa = 0.263 ) and ' good ' between the pre-hospital discharge score and that obtained in the week preceding discharge ( kappa = 0.639 ) . CONCLUSION STRATIFY performed poorly as a predictor of falls in a heterogeneous population of stroke patients . There is a need for a disease-specific rather than a generic falls risk assessment tool Abstract Objective To assess the effectiveness of a targeted , multiple intervention falls prevention programme in reducing falls and injuries related to falls in a subacute hospital . Design R and omised controlled trial of a targeted multiple intervention programme implemented in addition to usual care compared with usual care alone . Setting Three subacute wards in a metropolitan hospital specialising in rehabilitation and care of elderly patients . Participants 626 men and women aged 38 to 99 years ( average 80 years ) were recruited from consecutive admissions to subacute hospital wards . Intervention Falls risk alert card with information brochure , exercise programme , education programme , and hip protectors . Main outcome measures Incidence rate of falls , injuries related to falls , and proportion of participants who experienced one or more falls during their stay in hospital . Results Participants in the intervention group ( n = 310 ) experienced 30 % fewer falls than participants in the control group ( n = 316 ) . This difference was significant ( Peto log rank test P = 0.045 ) and was most obvious after 45 days of observation . In the intervention group there was a trend for a reduction in the proportion of participants who experienced falls ( relative risk 0.78 , 95 % confidence interval 0.56 to 1.06 ) and 28 % fewer falls result ed in injury ( log rank test P = 0.20 ) . Conclusions A targeted multiple intervention falls prevention programme reduces the incidence of falls in the subacute hospital setting The performance of a predictive model is overestimated when simply determined on the sample of subjects that was used to construct the model . Several internal validation methods are available that aim to provide a more accurate estimate of model performance in new subjects . We evaluated several variants of split- sample , cross-validation and bootstrapping methods with a logistic regression model that included eight predictors for 30-day mortality after an acute myocardial infa rct ion . R and om sample s with a size between n = 572 and n = 9165 were drawn from a large data set ( GUSTO-I ; n = 40,830 ; 2851 deaths ) to reflect modeling in data sets with between 5 and 80 events per variable . Independent performance was determined on the remaining subjects . Performance measures included discriminative ability , calibration and overall accuracy . We found that split- sample analyses gave overly pessimistic estimates of performance , with large variability . Cross-validation on 10 % of the sample had low bias and low variability , but was not suitable for all performance measures . Internal validity could best be estimated with bootstrapping , which provided stable estimates with low bias . We conclude that split- sample validation is inefficient , and recommend bootstrapping for estimation of internal validity of a predictive logistic regression model Objective : To further assess the validity and inter-rater reliability of the Elderly Mobility Scale ( EMS ) . Also whether the scale reflects elderly people 's perceptions regarding their mobility , and whether it can predict discharge destination , or likelihood of falling . Design : Question naire-based study completed on admission and weekly after this on all patients referred to physiotherapy for mobility problems over the course of one month . Setting : Care of the elderly wards in the Bristol General Hospital . Subjects : Sixty-six patients ( ages 66 - 69 years , 66 % female ) were included in the validity study . Nineteen patients ( ages 71 - 95 years , 47 % female ) were included in the inter-rater reliability study . Interventions : EMS , Barthel and patients ' perceptions of mobility were tested with routine physiotherapy treatment carried out as necessary . Main outcome measures : Concurrent validity was assessed by correlating EMS scores with Barthel scores using Spearman 's test . Inter-rater reliability was also tested using a Spearman 's correlation . EMS scores of patients were also evaluated in conjunction with whether or not they fell and their destination on discharge . Results : A significant correlation between EMS and Barthel scores indicated concurrent validity . Inter-rater reliability was demonstrated on 19 patients with a significant correlation between scores . No predictive validity could be ascribed to EMS in terms of discharge destination or likelihood of falling . OUTPUT:

Heterogeneity between studies indicates that the Morse Falls Scale and STRATIFY may still be useful in particular setting s , but that widespread adoption of either is unlikely to generate benefits significantly greater than that of nursing staff clinical judgment

MS2_dynamic_1_shot29

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Total hip arthroplasty is associated with a better long term outcome and lesser reoperation rates in the elderly but the risk of complications are beleived to be higher in very elderly patients . The study aims to compare the short-term results of cemented and cementless total hip arthroplasty ( THA ) in active patients > 80 years of age with femoral neck fractures . Methods Sixty-two consecutive patients underwent THA during the study period ( cemented—31 and cementless—31 ) . The mean age was 84 years ( 81–94 years ) . Patients in both groups were comparable in their preoperative variables . Functional and radiological assessment s were carried out using vali date d outcome measures . Complications were recorded . Results Fifty-one patients were available for final analysis after accounting for deaths and cases lost in follow-up . Of the 51 patients , 25 ( 49 % ) regained their pre-injury mobility status and 36 ( 70 % ) were community ambulant . Cementless THA was associated with significantly less surgical time , blood loss , transfusion rates and hospital stay . The overall mortality rates , complications , functional and radiological results were similar in both groups though the number of deaths in the perioperative period was significantly high in patients undergoing cemented THA . ConclusionS atisfactory improvement in function with low reoperation rates can be achieved irrespective of the technique used . Complication rates are higher when compared to younger patients undergoing the procedure . Risks and benefits should be carefully assessed and explained before subjecting these patients to THA BACKGROUND More than 220,000 persons 65 years and older fracture a hip every year in the United States . Although hip fractures have been considered as a single , homogeneous condition , there are two major anatomic types of proximal femoral fractures : intertrochanteric and femoral neck . The present study 's objective was to determine if the two types of hip fracture have different patient characteristics and sequelae . METHODS A prospect i ve study of 923 elderly patients admitted to seven Baltimore hospitals for a hip fracture between 1984 and 1986 . RESULTS Patients with intertrochanteric fractures were slightly older , sicker on hospital admission , had longer hospital stays , and were less likely at 2 months postfracture to have recovered activities of daily living than femoral neck fracture patients . Intertrochanteric fracture patients also had higher mortality rates at 2 and 6 months after fracturing . Long-term recovery ( 1 year ) did not differ between fracture type . CONCLUSIONS It appears that intertrochanteric fracture patients have intrinsic factors ( older age , poor health ) impacting upon their risk of fracture and ability to recover . Differences in patient characteristics and sequelae do exist between femoral neck and intertrochanteric hip fracture patients that impact upon recovery Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons . Sixty patients ( 56 % ) had died in the cemented group and 63 ( 60 % ) in the uncemented group . Respectively , three and two patients ( 2.7 % and 1.9 % ) were completely lost to followup . Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group ( 86.2 versus 76.3 ; mean difference 9.9 ; 95 % confidence interval [ CI ] , 1.9–17.9 ) . The prevalence of postoperative periprosthetic femoral fractures was 7.4 % in the uncemented group and 0.9 % in the cemented group ( hazard ratio [ HR ] , 9.3 ; 95 % CI , 1.16–74.5 ) . Barthel Index and EQ-5D scores were not different between the groups . Between 1 and 5 years , we found no additional infections or dislocations . The mortality rate was not different between the groups ( HR , 1.2 ; 95 % CI , 0.82–1.7 ) . Conclusions Both arthroplasties may be used with good medium-term results after displaced femoral neck fractures . The uncemented hemiarthroplasty may result in higher hip scores but appears to carry an unacceptably high risk of later femoral fractures . Level of Evidence Level I , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence Background The treatment of unstable intertrochanteric fractures in elderly is still controversial . The purpose of this study is to present treatment strategies for unstable intertrochanteric fractures with hemiarthroplasty using st and ard uncemented collared femoral st OUTPUT: Conclusion Cemented bipolar hemiarthroplasty and cementless bipolar hemiarthroplasty performed on elderly patients with unstable intertrochanteric fracture revealed similar mortality and complication rates ; however , the rate of LLD greater than 1 cm was significantly higher in the cemented group compared with the cementless group INPUT: We selected r and omly a consecutive series of 162 patients requiring hip replacement to receive either a cementless , hemispherical , modular , titanium acetabular cup or a cemented , all-polyethylene cup . These replacements were performed by two surgeons in four general hospitals . The same surgical technique was used and a 26 mm metal-head femoral component was used in every case . After exclusions , 115 hips were studied for differences in rates of wear and osteolysis . The mean clinical follow-up was eight years and the mean radiological follow-up , 6.5 years . The cementless cups wore at a mean rate of 0.15 mm per year and the cemented cups at 0.07 mm per year . This difference was significant ( p < 0.0001 ) . Our findings in this mid-term study suggest that cementless cups wear more than cemented cups We studied prospect ively the long-term results of the Charnley Elite-Plus femoral stem in 184 consecutive young patients ( 194 hips ) . There were 130 men and 54 women with a mean age of 49.1 years ( 21 to 60 ) . The predominant diagnosis was osteonecrosis of the femoral head ( 63.6 % , 117 patients ) . Clinical and radiological evaluation was undertaken at each follow-up . The mean follow-up was 11.2 years ( 10 to 12 ) . The mean pre-operative Harris hip score was 43.4 ( 12 to 49 ) which improved to 91 ( 59 to 100 ) at the final follow-up . The survival of the femoral stem at 12 years was 99 % with revision as the end-point . The mean annual linear wear of the polyethylene liner was 0.17 mm ( 0.13 to 0.22 ) . The prevalence of acetabular osteolysis was 10.8 % ( 21 hips ) and osteolysis of the calcar femorale 12.9 % ( 25 hips ) . A third-generation cementing technique , accurate alignment of the stem and the use of a 22 mm zirconia head were important factors in the prevention of aseptic loosening of the Elite Plus femoral stem in these high-risk young patients Background : We previously reported our two and five‐year results of arthroplasty with the Porous Coated Anatomic total hip prosthesis . We now report on the performance of this prosthesis at ten to fourteen years . Methods : The results of 311 total hip replacements in which a Porous Coated Anatomic prosthesis was inserted without cement in 279 patients were analyzed prospect ively . The average age of the patients at the time of the replacement was sixty-one years ( range , twenty to eighty‐one years ) . Sixty‐four patients ( seventy-six hips ) died postoperatively . Forty‐five patients ( forty‐seven hips ) were lost to follow‐up , and four were excluded because of their medical condition . One hundred and sixty‐eight patients ( 187 hips ) were followed for ten to fourteen years ( average , twelve years ) . Seventeen of those patients ( seventeen hips ) had a revision . Results : The overall survival rate ( with any revision as the end point ) was 90.0 % ± 5.4 % at fourteen years , with an average Harris hip score of 85 ± 14 points . The prevalence of thigh pain was 36 % ( fifty-six of 157 ) in the late period ( more than ten years postoperatively ) . Radiographs showed stable fixation , with bone ingrowth , of 83 % ( 130 ) of the 156 acetabular components and 88 % ( 137 ) of the 156 femoral components at the latest follow‐up evaluation . Men had a significantly higher rate of femoral osteolysis than did women ( p < 0.001 ) . The rates of acetabular and femoral osteolysis associated with 32‐mm femoral heads ( 49 % [ twenty-three ] of forty-seven and 70 % [ thirty-three ] of forty-seven , respectively ) were significantly higher ( p < 0.01 ) than those associated with 26‐mm heads ( 26 % [ twenty-eight ] of 109 and 30 % [ thirty-three ] of 109 , respectively ) . Despite this , revision ( removal or exchange of components ) was not directly related to head size ; instead , it was related to polyethylene thickness . Conclusions : There have been persistent problems with the Porous Coated Anatomic hip system , including thigh pain and an increasing prevalence of osteolysis with time . Revision because of aseptic loosening was related more to the thickness of the polyethylene liner than to the size of the femoral head . Femoral heads with a 32-mm diameter did not increase the risk for revision provided that an adequate thickness of polyethylene had been used Background Even though there are multiple studies documenting the outcome of the Charnley low-friction arthroplasty as well as abundant studies on uncemented arthroplasties , there is a dearth of comparative studies of the uncemented acetabular component and a cemented component . In this study we aim ed to document the long-term clinical and radiographic outcome as well as component survival in a r and omized controlled trial . Material s and methods Two hundred fifteen patients ( 240 hips ) were r and omly allocated to receive a cemented Charnley cup or uncemented Duraloc 1200 cup . All patients received cemented Charnley stems and were evaluated clinical ly and radiographically after 6 months , and 2 , 5 , and 10 years . Results Harris Hip Scores improved from 48.3 [ 95 % confidence interval ( CI ) 45.0–51.6 ] to 90.2 [ 95 % CI 87.9– OUTPUT:

RESULTS The meta- analysis did not reveal any effect of the type of acetabular component fixation on either survivorship or revision rate . The preference for cementless acetabular components on the basis of improved survivorship is not supported by the published evidence . Although concerns regarding aseptic loosening of cemented acetabular components may have led North American surgeons toward the nearly exclusive use of cementless acetabular components , the available literature suggests that the fixation of cemented acetabular components is more reliable than that of cementless components beyond the first postoperative decade

MS2_dynamic_1_shot30

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Pain reduction can be achieved by lowering proinflammatory cytokine levels in the blood . Transcutaneous electrical nerve stimulation ( TENS ) is a non-invasive physiotherapeutic re source for pain management , but evidence on the effectiveness of this device at reducing proinflammatory cytokines in the blood is unclear . This study systematic ally review s the literature on the effect of TENS on proinflammatory cytokines . Methods A systematic review protocol was developed based on search es of articles in six electronic data bases and references of retrieved articles , contact with authors , and repositories of clinical trials . Eligibility criteria : publication in peer- review ed journals , r and omized clinical trials , use of TENS in the experimental group , and pre- and post- measurements of proinflammatory cytokines in the blood . Selection of the studies and extraction of the data will be carried out by two review ers independently . Characteristics of the study , participants , interventions and outcomes were extracted and described . Assessment s were performed on the risk of bias , level of evidence and the size of the intervention effect in the studies , according to GRADE guidelines and the Cochrane H and book for Systematic Review s. Clinical and statistical assessment s compared the effects of the interventions ( meta- analysis ) , taking into consideration any influencing characteristics of the studies ( e.g. , methods and application sites ) . Discussion We anticipate that this review will strengthen evidence -based knowledge of the effect of TENS on proinflammatory cytokines and , as a result , direct new studies to benefit patients with specific pathologies . Systematic review registration PROSPERO , CRD42017060379 Background : Chronic pelvic pain is prevalent in 2 % of women population globally . The etiology is multifactorial . Even in the absence of pelvic pathology , there is a subgroup of women who do not respond to analgesic and anti-inflammatory therapy . Chronic pelvic pain can be inhibited by direct inhibition of impulses in the preganglionic afferent neuron by closing the hypothetical gate in the dorsal horn of the spinal cord . Transcutaneous electrical nerve stimulation ( TENS ) is based on the gate control theory of abolishing the painful stimuli by providing simultaneous inputs in larger myelinated nerve fibers . Aims and Objectives : This study was design ed to assess the effectiveness and safety of TENS in idiopathic chronic pelvic pain . Methods : It is a prospect i ve , experimental study to evaluate the effectiveness of TENS versus placebo in reducing pain severity in chronic pelvic pain ( G1 = 30 , G2 = 32 , G3 = 30 , and G0 = 30 ) . Patients with chronic pelvic pain due to benign lesions of genital tract , gastrointestinal , and renal disorders were excluded from the study after performing an ultrasound study of abdomen and pelvis . Ten treatment sessions ( 5 sessions/week ) of 30 min were conducted . Observations and Results : There was a significant improvement in pain scores in TENS group as compared with control group , and two patients were completely pain free following TENS therapy . Conclusion : In women patients with idiopathic chronic pelvic pain , TENS can be a useful intervention . TENS units are safe , economical , and easily commercially available In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias OBJECTIVE To observe the effect of transcutaneous acupoint electrical stimulation ( TAES ) on plasma ET , CGRP and serum IL-6 , S100beta during craniotomy . METHODS Fifty patients scheduled for neurosurgery were r and omly divided into TAES group ( n=25 ) and control group ( n=25 ) . TAES ( 2/100 Hz , 8 - 12 mA ) of bilateral Hegu ( LI 4)-Quchi ( LI 11 ) , Zusanli ( ST 36)-Sanyinjiao ( SP 6 ) was administrated for patients of TAES group starting 30 min before anesthesia till the end of the operation . Anesthesia of the patients was maintained with sevoflurane inhalation and intermittent intravenous injection of boluses of sulfenany and vecurnium bromide . Jugular venous blood sample s were taken at preanesthesia ( T0 ) , 1 hour after craniotomy ( T1 ) , closure complete ( T2 ) , 24 hours ( T3 ) and 48 hours ( T4 ) after operation respectively for detecting contents of plasma endothelin ( ET ) , calcitonin gene-related peptide ( CGRP ) and serum interleukin (IL)-6 , S100beta with radioimmunoassay and enzyme linked immunosorbent assay separately . RESULTS Compared with control group , plasma ET at T2 , serum IL-6 at T1 S100beta at T1 and T4 in TAES group all decreased significantly ( P < 0.01 , OUTPUT: It was observed through the meta- analysis synthesis measures that there were statistically significant differences following the use of TENS to reduce the general group of cytokines . When grouped by chronic disease , by postoperative setting s , or by individual studies in the case of IL-6 , it was observed that the significant reduction of cytokines related to the use of TENS was maintained . The use of TENS reduced the blood levels of proinflammatory cytokines ( we observed a protective factor of TENS in relation to inflammation ) . INPUT: Several authors have demonstrated the pivotal role of proinflammatory cytokines in inducing progressive cartilage degradation and secondary inflammation of the synovial membrane in osteoarthritis ( OA ) . It has recently been established that tumor necrosis factor (TNF)-alpha plays a well-defined role in the pathophysiology of inflammatory joint diseases and that binding to circulating soluble TNF-alpha receptors can inactivate it . We investigated the influence of mud pack treatment , which is able to diminish TNF-alpha serum values , on specific TNF receptor ( sTNF-R ) levels . Thirty-six patients with OA were enrolled and r and omized into two groups . Group A underwent mud pack treatment and group B underwent thermal bath treatment . A group of 20 healthy untreated subjects was used as a control . Blood sample s were collected at baseline and after treatment , and assays of sTNF-R55 and sTNF-R75 were performed in both groups . We found small changes in sTNF-Rs serum values but these were not statistically significant . sTNF-R55 serum values decreased by 0.4 % after the therapy in group A , while in group B the decrease was -17.7 % . sTNF-R75 was reduced by -21.17 % in group A and by -10.6 % in group B. In conclusion , through its thermic and ant/inflammatory activity mud pack treatment shows complex interaction with the most common factors of inflammatory and cartilage degradation . Our results suggest that the thermic component of this natural treatment is mainly involved in modulating inflammatory reaction and cartilage damage through binding of the circulating TNF , which controls the activation of the cells responsible for the production of proinflammatory cytokines We aim ed to evaluate the effectiveness of balneotherapy in fibromyalgia management . Fifty women with fibromyalgia under pharmacological treatment were r and omly assigned to either the balneotherapy ( 25 ) or the control ( 25 ) group . Four patients from the balneotherapy group and one patient from the control group left the study after r and omization . The patients in the balneotherapy group ( 21 ) had 2 thermomineral water baths daily for 2 weeks in Tuzla Spa Center . The patients in the control group ( 24 ) continued to have their medical treatment and routine daily life . An investigator who was blinded to the study arms assessed the patients . All patients were assessed four times ; at the beginning of the study , at the end of the 2nd week , the 1st month , and the 3rd month after balneotherapy . Outcome measures of the study were pain intensity , Fibromyalgia Impact Question naire ( FIQ ) , Beck Depression Inventory ( BDI ) , patient ’s global assessment , investigator ’s global assessment , SF-36 scores , and tender point count . Balneotherapy was found to be superior at the end of the cure period in terms of pain intensity , FIQ , Beck Depression Inventory , patient ’s global assessment , investigator ’s global assessment scores , and tender point count as compared to the control group . The superiority of balneotherapy lasted up to the end of the 3rd month , except for the Beck Depression Inventory score and the investigator ’s global assessment score . Significant improvements were observed in PF , GH , and MH subscales of SF-36 during the study period in the balneotherapy group ; however , no such improvement was observed in the control group . Balneotherapy was superior only in VT subscale at the end of therapy and at the end of the third month after the therapy as compared to the controls . It was concluded that balneotherapy provides beneficial effects in patients with fibromyalgia The purpose of this study was to investigate the clinical effects of balneotherapy in the treatment of Fibromyalgia Syndrome ( FMS ) and to determine if balneotherapy influences serum levels of inflammation markers , IL-1 , PGE2 and LTB4 . 24 primary fibromyalgia female patients diagnosed according to American College of Rheumatology criteria were included to the study . Their ages ranged between 33 and 55 years . FMS patients were r and omly assigned in two groups as , group 1 ( n = 12 ) and group 2 ( n = 12 ) . Group 1 received 20-min bathing , once in a day for five days per week . Patients participated in the study for 3 weeks ( total of 15 sessions ) in Denizli . Group 2 did not receive balneotherapy . FMS patients were evaluated by tenderness measurements ( tender point count and algometry ) , Visual Analogue Scale , Beck ’s Depression Index , Fibromyalgia Impact Question naire . Ten healthy women recruited group three as the controls . Serum PGE2 , LTB4 and IL1-α levels were measured in all three groups . The biochemical measurements and clinical assessment s were performed before and at the end of general period of therapy . Statistically significant alterations in algometric score , Visual Analogue score , Beck ’s Depression Index and PGE2 levels ( P < 0.001 ) , numbers of tender points ( P < 0.01 ) and Fibromyalgia Impact Question naire score ( P < 0.05 ) were found after the balneotherapy between group 1 and 2 . Mean PGE2 level of FMS patients were higher compared to healthy control group ( P < 0.0001 ) and decreased after the treatment period , only in group 1 ( P < 0.05 ) . As in the group 2 and 3 , detectable IL-1 and LTB4 measurements were insufficient , statistical analysis was performed , only in group 1 . After balneotherapy IL-1 and LTB4 significantly decreased in group 1 ( P < 0.05 ) . In conclusion , balneotherapy is an effective choice of treatment in patients with FMS relieving the clinical symptoms , and possibly influencing the inflammatory mediators Multidisciplinary treatment has proven to be the best therapeutic option to fibromyalgia ( FM ) and physiotherapy has OUTPUT:

CONCLUSION Study data confirms that spa therapy could improve the symptoms of fibromyalgia including pain , depression and minor symptoms

MS2_dynamic_1_shot31

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design OBJECTIVE To determine whether a multicomponent health promotion intervention for Dutch adolescents ( defined as persons between 12 and 14 years of age ) would be successful in influencing body composition and dietary and physical activity behavior in both the short and long terms . DESIGN R and omized controlled trial . SETTING Ten intervention and 8 control prevocational secondary schools . PARTICIPANTS A total of 1108 adolescents ( mean age , 12.7 years ) . Intervention An interdisciplinary program with an adapted curriculum for 11 lessons in biology and physical education and environmental change options . MAIN OUTCOME MEASURES Body height and weight , waist circumference , 4 skinfold thickness measurements , and dietary and physical activity behavior data . RESULTS Multilevel analyses showed that the intervention remained effective in preventing unfavorable increases in important measures of body composition after 20-month follow-up in girls ( biceps skinfold and sum of 4 skinfolds ) and boys ( triceps , biceps , and subscapular skinfolds ) . Consumption of sugar-containing beverages was significantly lower in intervention schools both after intervention ( boys : -287 mL/d ; 95 % confidence interval [ CI ] , -527 to -47 ; girls : -249 ; -400 to -98 ) and at 12-month follow-up ( boys : -233 ; -371 to -95 ; girls : -271 ; -390 to -153 ) . For boys , screen-viewing behavior was significantly lower in the intervention group after 20 months ( -25 min/d ; 95 % CI , -50 to -0.3 ) . No significant intervention effects on consumption of snacks or active commuting to school were found . CONCLUSION The Dutch Obesity Intervention in Teenagers program result ed in beneficial effects on the sum of skinfold thickness measurements in girls and consumption of sugar-containing beverages in both boys and girls in both the short and long terms Background School-based interventions that target prevention of overweight and obesity in children have been tested with mixed results . Thus , successful interventions are still called for . The aim of the present study was to investigate effects of a multicomponent school-based intervention programme targeting physical activity , sedentary and dietary behaviours on anthropometric outcomes . Methods A 20-month intervention was evaluated in a cluster r and omised , controlled study of 1324 11-year-olds . Outcome variables were body mass index ( BMI ) , BMI -for-age z-score ( BMI z ) , waist circumference ( WC ) , waist-to-height ratio ( WTHR ) and weight status ( International Obesity Task Force 's cut-offs ) . Weight , height and WC were measured objective ly ; pubertal status was self-reported and parental education was self-reported by the parents . Intervention effects were determined by one-way analysis of covariance and logistic regression , after checking for clustering effects of school , and moderating effects of gender , pubertal status and parental education . Results Beneficial effects were found for BMI ( p=0.02 ) and BMI z ( p=0.003 ) in girls , but not in boys . While a beneficial effect was found for BMI ( p=0.03 ) in participants of parents reporting a high level of education , a negative effect was found for WTHR in participants with parents reporting a low level of education ( p=0.003 ) . There were no intervention effects for WC and weight status . Conclusions A multicomponent 20-month school-based intervention had a beneficial effect on BMI and BMI z in adolescent girls , but not in boys . Furthermore , children of higher educated parents seemed to benefit more from the intervention , and this needs attention in future interventions to avoid further increase in social inequalities in overweight and obesity Background Although school-based interventions to promote physical activity in adolescents have been suggested in several recent review s , questions have been raised regarding the effects of the strategies and the methodology applied and for whom the interventions are effective . The aim of the present study was to investigate effects of a school-based intervention program : the HEalth in Adolescents ( HEIA ) study , on change in physical activity , and furthermore , to explore whether potential effects varied by gender , weight status , initial physical activity level and parental education level . Methods This was a cluster r and omized controlled 20 month intervention study which included 700 11-year-olds . Main outcome -variable was mean count per minute ( cpm ) derived from ActiGraph accelerometers ( Model 7164/GT1 M ) . Weight and height were measured objective ly . Adolescents reported their pubertal status in a question naire and parents reported their education level on the consent form . Linear mixed models were used to test intervention effects and to account for the clustering effect of sampling by school . Results The present study showed an intervention effect on overall physical activity at the level of p = 0.05 with a net effect of 50 cpm increase from baseline to post intervention in favour of the intervention group ( 95 % CI −0.4 , 100 ) . Subgroup analyses showed that the effect appeared to be more profound among girls ( Est 65 cpm , CI 5 , 124 , p = 0.03 ) and among participants in the low OUTPUT: The analysis of the interventions using the ALBD Community Action Model showed that Preparation and Promotion were used much more frequently than Policy and Physical projects . Conclusion Noted improvements were an increase in use of objective measures . Lack of theory , weak method ological design and a lack of reliable and valid measurement were observed . INPUT: We develop novel mixed effects models to examine the role of health traits on the status of peoples ' close friendship nominations in the Framingham Heart Study . The health traits considered are both mutable ( body mass index ( BMI ) , smoking , blood pressure , body proportion , muscularity , and depression ) and , for comparison , basically immutable ( height , birth order , personality type , only child , and h and edness ) ; and the traits have varying degrees of observability . We test the hypotheses that existing ties ( i.e. close friendship nominations ) are more likely to dissolve between people with dissimilar ( mutable and observable ) health traits whereas new ties are more likely to form between those with similar ( mutable and observable ) traits while controlling for persons ' age , gender , geographic separation , and education . The mixed effects models contain r and om effects for both the nominator ( ego ) and nominated ( alter ) persons in a tie to account for the fact that people were involved in multiple relationships and contributed observations at multiple exams . Results for BMI support the hypotheses that people of similar BMI are less likely to dissolve existing ties and more likely to form ties , while smoker to non-smoker ties were the least likely to dissolve and smoker to smoker ties were the most likely to form . We also vali date d previously known findings regarding homophily on age and gender , and found evidence that homophily also depends upon geographic separation . Copyright © 2011 John Wiley & Sons , Human population s are both highly cooperative and highly organized . Human interactions are not r and om but rather are structured in social networks . Importantly , ties in these networks often are dynamic , changing in response to the behavior of one 's social partners . This dynamic structure permits an important form of conditional action that has been explored theoretically but has received little empirical attention : People can respond to the cooperation and defection of those around them by making or breaking network links . Here , we present experimental evidence of the power of using strategic link formation and dissolution , and the network modification it entails , to stabilize cooperation in sizable groups . Our experiments explore large-scale cooperation , where subjects ’ cooperative actions are equally beneficial to all those with whom they interact . Consistent with previous research , we find that cooperation decays over time when social networks are shuffled r and omly every round or are fixed across all rounds . We also find that , when networks are dynamic but are up date d only infrequently , cooperation again fails . However , when subjects can up date their network connections frequently , we see a qualitatively different outcome : Cooperation is maintained at a high level through network rewiring . Subjects preferentially break links with defectors and form new links with cooperators , creating an incentive to cooperate and leading to substantial changes in network structure . Our experiments confirm the predictions of a set of evolutionary game theoretic models and demonstrate the important role that dynamic social networks can play in supporting large-scale human cooperation Theoretical models suggest that social networks influence the evolution of cooperation , but to date there have been few experimental studies . Observational data suggest that a wide variety of behaviors may spread in human social networks , but subjects in such studies can choose to befriend people with similar behaviors , posing difficulty for causal inference . Here , we exploit a seminal set of laboratory experiments that originally showed that voluntary costly punishment can help sustain cooperation . In these experiments , subjects were r and omly assigned to a sequence of different groups to play a series of single-shot public goods games with strangers ; this feature allowed us to draw networks of interactions to explore how cooperative and uncooperative behaviors spread from person to person to person . We show that , in both an ordinary public goods game and in a public goods game with punishment , focal individuals are influenced by fellow group members ’ contribution behavior in future interactions with other individuals who were not a party to the initial interaction . Furthermore , this influence persists for multiple periods and spreads up to three degrees of separation ( from person to person to person to person ) . The results suggest that each additional contribution a subject makes to the public good in the first period is tripled over the course of the experiment by other subjects who are directly or indirectly influenced to contribute more as a consequence . These results show experimentally that cooperative behavior cascades in human social networks Exponential r and om graph modeling ( ERGM ) is used here to test hypotheses derived from human behavioral ecology about the adaptive nature of human food sharing . Respondents in all ( n = 317 ) households in the fishing and sea-hunting village of Lamalera , Indonesia , were asked to name those households to whom they had more frequently given ( and from whom they had more frequently received ) food during the preceding sea-hunting season . The responses were used to construct a social network of between-household food-sharing relationships in the village . The results show that kinship , proximity , and reciprocal sharing all strongly increase the probability of giving food to a household . The effects of kinship and distance are relatively independent of each other , although reciprocity is more common among residentially and genealogically close households . The results show support for reciprocal altruism as a motivation for food sharing , while kinship and distance appear to be important partner-choice criteria Information exchanges , debates , and negotiations through community social networks are essential to ensure the sustainability of the development process initiated in participatory research . The authors analyze the structural properties and robustness of a discussion network about mercury issues in a community in the Brazilian Amazon involved in a participatory research aim ed at reducing exposure to the pollutant . Most of the villagers are connected in a large network and are separated from other individuals by few intermediaries . The structure of the discussion network displays resilience to the r and om elimination of villagers but shows vulnerability to the removal of one villager who has been a long-term collaborator of the project . Although the network exhibits a structure likely to favor an efficient flow of information , results show that specific actions should be taken to stimulate the emergence of a pool of opinion leaders and increase the redundancy of discussion channels The health benefits of delaying the introduction of complementary foods to infants ' diets are widely known . Many studies have shown that mothers with the support of close social network members are more compliant with medical recommendations for infant feeding . In our study , we examine the effects of a broader spectrum of network members ( 40 people ) on mothers ' infant feeding decisions . The survey was conducted in Oaxaca , Mexico as part of a follow-up to a nationwide Mexican OUTPUT:

Second , we show that network composition , individual network central ity , and network structure are associated with important health behaviors and health and development outcomes in different context s across multiple levels of analysis and across distinct network types . Lastly , we highlight the opportunities for health research ers and practitioners in LMICs to 1 ) design effective studies and interventions in LMICs that account for the sociocentric network positions of certain individuals and overall network structure , 2 ) measure the spread of outcomes or intervention externalities , and 3 ) enhance the effectiveness and efficiency of aid based on knowledge of social structure .

MS2_dynamic_1_shot32

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The efficacy of clodronate to reduce bone loss around uncemented stems after total hip arthroplasty ( THA ) was evaluated . Ninety-one patients operated with uncemented THA were r and omized to receive either intramuscular clodronate at a dose of 100 mg weekly for 12 months or no treatment . Periprosthetic and contralateral bone mineral density ( BMD ) scans were performed and biochemical markers of bone turnover measured at baseline and at 3 , 6 , and 12 months . At month 12 , with the exception of Gruen zones 4 and 5 , patients treated with clodronate showed less bone loss at all zones , reaching statistical significance ( P < 0.05 ) in Gruen zones 2 and 6 ( difference of 6.6 and 5.9 % , respectively ) . Analysis of data according to gender revealed sex-related differences in bone loss and efficacy of treatment . After 12 months , the difference in bone loss between treated and untreated women in five out of seven Gruen zones ranged from 6.2 to 13.3 % ( SS at zones 2 and 6 ) , whereas comparison between treated and untreated men showed no BMD differences in all zones ( P > 0.05 ) . Median percent changes in serum levels of markers of bone metabolism by gender were consistent with BMD changes . A 1-year treatment with intramuscular clodronate determined a significant reduction of bone loss after THA . This was mainly attributed to its greater efficacy in the female population , which is at higher risk for bone loss . This observation suggests the need for the characterization of high-risk subjects as potential c and i date s for prevention strategies Summary Forty-three patients who had undergone cementless THA were r and omly assigned to receive no osteoactive drug or oral risedronate for 6 months . Postoperative decrease of BMD in the risedronate group was significantly lower than that seen in the control group in zones 1 , 2 , 3 , 6 , and 7 . Introduction Proximal bone resorption around the femoral stem often has been observed after total hip arthroplasty ( THA ) , could lead to late stem loosening . We previously reported the efficacy of etidronate on periprosthetic bone resorption after cementless THA . Recently risedronate is suggested to be effective for the prevention and treatment of for osteoporosis . The purpose of the present study was to evaluate the effects of risedronate on periprosthetic bone loss after cementless THA . Methods Forty-three patients who had undergone cementless THA were r and omly assigned to receive no osteoactive drug ( 21 patients ) or oral risedronate 2.5 mg/day ( 22 patients ) for 6 months . Three patients were eliminated from the risedronate group because of dyspepsia . Periprosthetic bone mineral density ( BMD ) in seven regions of interest based on the zones of Gruen et al. was measured with dual energy X-ray absorptiometry at 3 weeks and 6 months postoperatively . Results At 6 months after surgery , postoperative decrease of BMD in the risedronate group was significantly lower than that seen in the control group in zones 1 , 2 , 3 , 6 , and 7 ( p < 0.05 , p < 0.01 , p < 0.01 , p < 0.05 , and p < 0.05 , respectively ) . Conclusion These outcomes suggested that risedronate might reduce the periprosthetic bone resorption after cementless THA Background and Aims : Periprosthetic bone loss , especially in the proximal part of the femur , is common after cemented and uncemented total hip arthroplasty ( THA ) . Short-term studies suggest that bisphosponates can minimize this bone loss related to stress-shielding phenomenon . The aim of the present r and omized study was to investigate whether the positive effect of a 6 months alendronate treatment postoperatively still exists at five-year follow up . Material s and Methods : Sixteen uncemented primary THA patients were r and omized to receive either 10 mg alendronate + 500 mg calcium ( n = 7 ) or 500 mg calcium only ( n = 9 ) daily for 6 months postoperatively . Periprosthetic bone mineral density ( BMD ) was measured with the dual X-ray absorptiometry ( DXA ) postoperatively and at 6 , 12 , 24 , 36 and 60 months follow-up . Results : At the 5-year follow up , the calcium group showed mean BMD decreases of 23.1 % ( SD 14.6 ) in the proximal part of the femur ( prROI ) and 9.6 % ( SD 14.9 ) in total femoral regions of interest ( totROI ) . In the alendronate group the corresponding BMD decreases were 13.6 % ( SD 19.0 ) and 3.9 % ( SD 7.6 ) respectively . The positive effect of alendronate was already demonstrated during the first six months postoperatively . Subsequently the bone loss was equal in both groups , and the 5-year BMD changes were not significantly different between the groups . Conclusions : Alendronate seems to decrease early periprosthetic bone loss after arthroplasty but this pilot study could not provide enough evidence that the positive effect noted in the early postoperative period is still maintained 5 years after the operation BACKGROUND Bone mineral density decreases after total knee arthroplasty and is believed to affect prosthetic fixation . Treatment with alendronate has been shown to improve short-term bone mineral density after total knee arthroplasty ; however , the long-term effects of this therapy are unknown . The purpose of this study was to evaluate the long-term effects of a six-month course of alendronate on bone mineral density after total knee arthroplasty . METHODS Sixty patients were r and OUTPUT: The efficacy was more potent for the second and the third generation of BPs than the first generation . Conclusions The overall moderate evidence from the RCTs confirmed the significantly short-term and middle-term efficacy of BPs on periprosthetic bone loss after joint arthroplasty . INPUT: Background We have previously reported that 6 months of oral treatment with clodronate reduced the migration of the NexGen total knee prosthesis during the first postoperative year , as measured by radiostereometry ( RSA ) . We now report the 4-year results . Methods This was a double-blind r and omized study , using RSA with maximal total point motion ( MTPM ) . Results With analysis according to the “ intention to treat ” principle , the only remaining difference between the groups at 4 years was reduced rotation around the transverse axis ( a secondary variable ) in the clodronate group . However , 3 patients ( all clodronate ) did not take any tablet after surgery . If they are excluded , there was an almost statistically significant difference between the groups at 4 years regarding MTPM from baseline , with the clodronate group showing 25 % less migration . From 1 to 4 years , there was no difference in migration rate by MTPM , but there was a continuous increase in rotation around the transverse axis in the controls , which differed from the clodronate group . There were no cases of aseptic loosening . 2 patients had migration of more than 1.3 mm from baseline to 4 years ; neither of them had taken clodronate . The others had migration of less than 0.9 mm . Interpretation Because migration was clearly reduced by clodronate during the first postoperative year , and there was still a difference at 4 years when analyzed per protocol , it appears likely that this treatment can diminish the risk of loosening . The difference in the number of outliers also points in this direction , and may be more relevant than mean migration values BACKGROUND High-flexion total knee arthroplasty was introduced to meet the dem and s of daily activity requiring increased knee flexion . However , concerns have been raised regarding the fixation of high-flexion total knee arthroplasty components and increased rates of loosening have been reported . To date , migration , and thus fixation , of high-flexion total knee arthroplasty components has not been analyzed and the preferential bearing type ( mobile or fixed ) is unknown . METHODS Of eighty-six consecutive eligible patients , seventy-four patients ( seventy-eight knees ) scheduled for total knee arthroplasty were r and omized to one of four Legacy Posterior Stabilized ( LPS ) total knee prosthesis design s : ( 1 ) LPS-Flex mobile , ( 2 ) LPS-Flex fixed , ( 3 ) LPS mobile , and ( 4 ) LPS fixed . The primary outcome was component migration measured with use of Roentgen stereophotogrammetric analysis , and secondary outcomes were postoperative knee flexion and extension and Knee Society Score . Patients were evaluated postoperatively at six , twelve , twenty-six , and fifty-two weeks and annually thereafter . At the five-year follow-up , eight patients had died and two patients were lost to follow-up . Seventy-seven tibial and forty-two femoral components were suitable for migration measurements . RESULTS The overall five-year migration of the seventy-seven tibial components was not significantly different among the four total knee prosthesis design s ( compared with the LPS fixed design , the range of overall mean differences for the other three design s was 0.02 to 0.25 mm ) and migration was comparable at the two and five-year follow-up . Migration stabilized in all but three components ( two LPS-Flex mobile and one LPS fixed ) ; one of these components has already been revised and was aseptically loose . The overall five-year migration of the forty-two femoral components was comparable among the four design s ( compared with the LPS fixed design , the range of overall mean differences for the other three design s was 0.01 to 0.18 mm ) and was similar at two and five years postoperatively . One femoral component ( LPS-Flex mobile ) migrated excessively . In patients who had a mean postoperative flexion of ≥ 125 ° or a maximum flexion of ≥ 135 ° during the one to five-year follow-up period , migration of high-flexion components was comparable with that of conventional components and indicative of appropriate fixation . Postoperative flexion , extension , Knee Society Score , and Knee Society Score function were comparable during the five-year follow-up period and at the two and five-year follow-up . CONCLUSIONS The LPS-Flex total knee prosthesis with either a mobile or a fixed bearing had migration comparable that of with its conventional counterpart and is expected to have similar ( excellent ) long-term survival in these patients . LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence Sixty-two knees ( 60 patients ) were r and omized to four noncemented groups . In Groups 1 , 3 , and 4 , the bone cuts were made with a cooled saw blade . In Group 1 , 15 patients were operated on with the porous coated Osteonic 7000 tibial component . In Group 2 , 15 patients were operated on with the same tibial component as in Group 1 but with the use of a st and ard saw blade . In Group 3 , 16 patients were operated on with the hydroxyapatite-coated Osteonic tibial component , and in Group 4 , 16 patients were operated on with the hydroxyapatite Duracon tibial component . All patients were followed up clinical ly and with roentgenstereometric analysis . There were no differences among the groups regarding clinical outcome . One knee was revised ( Group 2 ) after 1 year because of loosening of the tibial component . The maximum migration at 1 year was 1.7 mm in Group 1 , 1.9 mm in Group 2 , 1.3 mm in Group 3 , and 1 mm in Group 4 . At the 2-year followup , the migrations were 1.8 mm , 1.5 mm , 1.4 mm , and 1 mm in Groups 1 , 2 , 3 , and 4 , respectively . The inducible displacement that occurred at 1 year was 0.6 mm in Group 1 , OUTPUT:

Cemented and uncemented tibial components had different migration patterns . For cemented tibial components there was no difference in migration between all-poly and metal-backed components , between mobile bearing and fixed bearing , between cruciate retaining and posterior stabilized . Furthermore , no difference existed between TKR measured with model-based RSA or marker-based RSA methods . For uncemented TKR there was some variation in migration with the highest migration for uncoated TKR . Interpretation - The results from this meta- analysis on RSA migration of TKR are in line with both the survival analyses results from joint registries of these TKRs as well as revision rates results from meta-analyses , thus providing further proof for the association between early migration and late revision for loosening .

MS2_dynamic_1_shot33

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The aim of the study was to evaluate the efficacy of endosurgery for generalized appendiceal peritonitis in children . Laparoscopic appendectomy ( LA ) was used as a procedure of choice in all forms of peritonitis and its complications . Original three-trocar approach and modified Gotz technique were applied . From 1991 to 2002 LA was performed in 4024 children aged from 7 days to 16 years , in 298 ( 5.8 % ) patients generalized peritonitis was diagnosed current . Prospect i ve comparative r and omized study includes 200 patients with generalized appendicular peritonitis . Contraindications were in 7 % cases , rate of conversion to open surgery--2.1 % . Duration of surgery was 61.7 + /- 24 min in laparoscopic group ( LG ) vs 73.2 + /- 31 min in open surgery group ( OG ) . Patients of LG demonstrated earlier repair of many functions . There were no lethal outcomes . Rate of minor surgical complications was 10 % in LG and 21 % in OG ( p < 0.05 ) , major complications--13 and 16 % ( p = 0.55 ) , respectively . There was no difference in rate of abscess formation ( 4 % ) . Rate of pneumonia was 1 % in LG and 3 % in OG ( p < 0.05 ) , rate of critical conditions--2 and 4 % ( p = 0.067 ) . Hospital stay was 15.7 + /- 3.1 days in LG and 21.2 + /- 3.8 days in OG . It is concluded that laparoscopic approach could be successfully used in more than 90 % cases of generalized appendicular peritonitis . Endosurgery has many advantages over open surgery . LA demonstrates the best benefits in generalized peritonitis OBJECTIVE . The role of laparoscopic surgery in pediatric inguinal hernia repair is unclear . We aim ed to compare day-case laparoscopic hernia repair with open repair . METHODS . A prospect i ve , single-blinded r and omized study in children aged 4 months to 16 years with unilateral inguinal hernia was performed . The primary outcome measure was the time to normal daily activities after surgery . Secondary outcome measures included postoperative pain , time in the operation room , results , and complications . RESULTS . Eighty-nine patients were enrolled ( laparoscopic hernia repair : 47 , open repair : 42 ) . The mean number of days to normal activity after laparoscopic hernia repair and open repair was 2.4 and 2.5 , respectively . Thirty-seven ( 79 % ) patients with laparoscopic hernia repair and 20 ( 42 % ) with open repair required rescue analgesia postoperatively . The median pain score in the second postoperative morning was significantly higher after laparoscopic hernia repair . The median times in the operation room for laparoscopic hernia repair and open repair were 63 and 38 minutes , respectively . Surgical and cosmetic results were similar at up to 2 years ' follow-up . CONCLUSIONS . Recovery and outcome were similar after open repair and laparoscopic hernia repair in children . Laparoscopic hernia repair was associated with increased theater time and postoperative pain Although laparoscopic procedures are currently in vogue in general surgery , the role of this approach in children has not been prospect ively evaluated in the United States using the new instrumentation now available to us . To assess the value of laparoscopic appendectomy ( LA ) in childhood , we prospect ively compared 14 LAs with 50 open appendectomies ( OA ) over 6 months in a single children 's hospital . Antibiotic usage was at the discretion of the surgeon regardless of the procedure performed and was not different between groups . LA was performed under the direction of a single laparoscopy-trained surgeon and patient selection was based on parental consent . A three-puncture LA technique was used ; children from this group were allowed to return to full activities as soon as they were comfortable . There were no significant differences between groups for severity of disease , age , weight , hospital cost , or complications . The types of complications that developed were comparable in both groups . The percent of complicated appendicitis ( gangrene or perforation ) was 32 % in the OA group and 36 % in the LA group . Patients in the LA group spent significantly fewer days in the hospital and returned to unrestricted activities ( school , athletics , etc ) faster than patients in the OA group . LA is approximately $ 1,000 more expensive than OA , the differences being easily explainable by the cost of the disposable supplies necessary for the procedure ( laser fibers , trocars , etc ) , but because of the shorter hospital stay in the LA group the mean total cost for each group was comparable . These data suggest that although there appears to be no cost advantage , LA shortens the hospital stay and allows children to return to unrestricted activity sooner than OA . ( ABSTRACT TRUNCATED AT 250 WORDS Background : The aim of this study was to evaluate prospect ively whether laparoscopic ( LA ) and open appendectomy ( OA ) are equally safe and feasible in the treatment of pediatric appendicitis . Methods : A total of 517 children with acute appendicitis were r and omly assigned to undergo LA or OA appendectomy , based on the schedule of the attending surgeon on call . Patient age , sex , postoperative diagnosis , operating time , level of training of surgical resident , length of postoperative hospitalization , and minor and major postoperative complications were recorded . Chi-square analysis and the Student t-test were used for statistical analysis . Results : In all , 376 OA and 141 LA were performed . The two groups were comparable in terms of patient demographics and the incidence of perforated appendicitis . The operative time was also similar ( 47.3 ± 19. OUTPUT: Total hospital costs of the laparoscopic approaches were found to be insignificantly increased compared to the open techniques . This review further supports the use of minimally invasive surgery ( MIS ) in pediatric population s , demonstrating that the three types laparoscopic procedures review ed result ed in better patient outcomes compared to open procedures , in the form of reduced LOS and overall complication rates . Increased utilization of this approach may prove beneficial to pediatric patients INPUT: OBJECTIVE Given the perceived technical dem and s of laparoscopic appendectomy and the expected postoperative morbidity in patients with a well-defined abscess , initial percutaneous drainage has become an attractive option in this patient population . This strategy allows for a laparoscopic appendectomy to be performed in an elective manner at the convenience of the surgeon . However , the medical burden on the patient and on the quality of patient outcomes has not been described in the literature . Therefore , we audited our experience with initial percutaneous drainage followed by laparoscopic interval appendectomy to evaluate the need for a prospect i ve trial . METHODS After institutional review board approval , a retrospective chart review was performed on all children who presented with perforated appendicitis and a well-defined abscess and were treated by initial percutaneous aspiration/drainage followed by interval appendectomy between January 2000 and September 2006 . Continuous variables are listed with st and ard deviation . RESULTS There were 52 patients with a mean age of 9.0 + /- 3.9 years and weight of 34.4 + /- 18.8 kg . The mean duration of symptoms at presentation was 8.4 + /- 7.6 days . Percutaneous aspiration only was performed in 2 patients . The mean volume of fluid on initial aspiration/drain placement was 76.3 + /- 81.1 mL. The mean time to appendectomy was 61.9 + /- 25.2 days . The laparoscopic approach was used in 49 patients ( 94.2 % ) , of which one was converted to an open operation . The mean length of hospitalization after interval appendectomy was 1.4 + /- 1.4 days . A recurrent abscess developed in 17.3 % of the patients . Six patients ( 11.5 % ) required another drainage procedure . The mean total charge to the patients was $ 40,414.02 . There were 4 significant drain complications ( ileal perforation , colon perforation , bladder perforation , and buttock/thigh necrotizing abscess ) . The child with the ileal perforation after drain placement is the only patient who failed initial nonoperative therapy . CONCLUSIONS The use of initial percutaneous aspiration/drainage of periappendiceal abscess followed by interval appendectomy is an effective approach . However , this management poses complication risks and uses considerable re sources . Therefore , this strategy should be compared with early operation in a prospect i ve trial AIM This prospect i ve study was done to evaluate the feasibility and safety of immediate appendicectomy in the presence of appendicular mass . METHODS A prospect i ve , nonr and omized study was conducted over 46 consecutive patients ( mean age : 24 ± 8.76 years ) presenting with an appendicular mass over a 4-year period . They were subjected for immediate appendicectomy within 24 h of admission . RESULTS The appendix was identified and removed in all 46 patients at operation . Peri-appendiceal abscesses were present in 25 % ( 11 of 46 ) . There was difficulty with adhesolysis and localization of the appendix in 10%(4 ) of patients . Superficial wound infection had occurred in 8(17 % ) while deep wound infection had occurred in 9%(4 ) patients . The mean hospital stay was 3 ± 0.25 day . No major complications had occurred . CONCLUSIONS Early surgical intervention in patients with an appendicular mass is feasible , safe and avoids the consequences of the misdiagnosis and mistreatment of other surgical pathologies PURPOSE The aim of of this study was to evaluate prospect ively the long-term outcome of mesocolic and pelvic diverticular abscesses of the left colon . METHODS Between October 1986 and October 1997 , a total of 465 patients urgently admitted to our hospital with a suspected diagnosis of acute left-sided colonic diverticulitis had a CT scan . Of 76 patients ( 17 percent ) who had an associated mesocolic or pelvic abscess , 3 were lost to follow-up . The remaining 73 patients ( 45 with a mesocolic abscess and 28 with a pelvic abscess ) were followed for a median of 43 months . RESULTS of the 45 patients with a mesocolic abscess , 7 ( 15 percent ) required surgery during their first hospitalization versus 11 ( 39 percent ) of the 28 patients with a pelvic abscess ( P = 0.04 ) . At the end of follow-up , 22 ( 58 percent ) of the 38 patients with a mesocolic abscess who had successful conservative treatment during their first hospitalization did not need surgical treatment vs. 8 ( 47 percent ) of the 17 who had a pelvic abscess . Altogether , 51 percent of the patients with a mesocolic abscess had surgical treatment versus 71 percent of those with a pelvic abscess ( P = 0.09 ) . CONCLUSIONS Considering the poor outcome of pelvic abscess associated with acute left-sided colonic diverticulitis , percutaneous drainage followed by secondary colectomy seems justified . Mesocolic abscess by itself is not an absolute indication for colectomy PURPOSE Prospect i ve evaluation was undertaken of surgical findings , complications , morbidity , and hospital stay between initial nonsurgical management versus early surgical intervention of an appendicular mass . METHODS A prospect i ve , nonr and omized study was conducted of 82 consecutive patients ( mean age , 6.9 + /- 3.3 years ) presenting with an appendicular mass over a 5-year period . They were categorized as group 1 , 58.5 % ( 48 of 82 ) nonsurgically managed and an interval appendectomy performed at a mean period of 8.6 + /- 4.6 weeks and group 2 , OUTPUT:

Operation with appendectomy for appendiceal mass carries a high risk of complications compared with conservative treatment or drainage . Drainage may lower the risk of treatment failure but entails a risk of complications .

MS2_dynamic_1_shot34

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Although resveratrol has widely been studied for its potential health benefits , little is known about its metabolic effects in humans . Our aims were to determine whether the polyphenol resveratrol improves insulin sensitivity in type 2 diabetic patients and to gain some insight into the mechanism of its action . After an initial general examination ( including blood chemistry ) , nineteen patients enrolled in the 4-week-long double-blind study were r and omly assigned into two groups : a resveratrol group receiving oral 2 × 5 mg resveratrol and a control group receiving placebo . Before and after the second and fourth weeks of the trial , insulin resistance/sensitivity , creatinine-normalised ortho-tyrosine level in urine sample s ( as a measure of oxidative stress ) , incretin levels and phosphorylated protein kinase B (pAkt):protein kinase B ( Akt ) ratio in platelets were assessed and statistically analysed . After the fourth week , resveratrol significantly decreased insulin resistance ( homeostasis model of assessment for insulin resistance ) and urinary ortho-tyrosine excretion , while it increased the pAkt : Akt ratio in platelets . On the other h and , it had no effect on parameters that relate to β-cell function ( i.e. homeostasis model of assessment of β-cell function ) . The present study shows for the first time that resveratrol improves insulin sensitivity in humans , which might be due to a resveratrol-induced decrease in oxidative stress that leads to a more efficient insulin signalling via the Akt pathway The red grape constituent resveratrol possesses cancer chemopreventive properties in rodents . The hypothesis was tested that , in healthy humans , p.o . administration of resveratrol is safe and results in measurable plasma levels of resveratrol . A phase I study of oral resveratrol ( single doses of 0.5 , 1 , 2.5 , or 5 g ) was conducted in 10 healthy volunteers per dose level . Resveratrol and its metabolites were identified in plasma and urine by high-performance liquid chromatography-t and em mass spectrometry and quantitated by high-performance liquid chromatography-UV . Consumption of resveratrol did not cause serious adverse events . Resveratrol and six metabolites were recovered from plasma and urine . Peak plasma levels of resveratrol at the highest dose were 539 ± 384 ng/mL ( 2.4 μmol/L , mean ± SD ; n = 10 ) , which occurred 1.5 h post-dose . Peak levels of two monoglucuronides and resveratrol-3-sulfate were 3- to 8-fold higher . The area under the plasma concentration curve ( AUC ) values for resveratrol-3-sulfate and resveratrol monoglucuronides were up to 23 times greater than those of resveratrol . Urinary excretion of resveratrol and its metabolites was rapid , with 77 % of all urinary agent-derived species excreted within 4 h after the lowest dose . Cancer chemopreventive effects of resveratrol in cells in vitro require levels of at least 5 μmol/L. The results presented here intimate that consumption of high-dose resveratrol might be insufficient to elicit systemic levels commensurate with cancer chemopreventive efficacy . However , the high systemic levels of resveratrol conjugate metabolites suggest that their cancer chemopreventive properties warrant investigation . ( Cancer Epidemiol Biomarkers Prev 2007;16(6):1246–52 BACKGROUND The many putative beneficial effects of the polyphenol resveratrol include an ability to bolster endogenous antioxidant defenses , modulate nitric oxide synthesis , and promote vasodilation , which thereby improves blood flow . Resveratrol may therefore modulate aspects of brain function in humans . OBJECTIVE The current study assessed the effects of oral resveratrol on cognitive performance and localized cerebral blood flow variables in healthy human adults . DESIGN In this r and omized , double-blind , placebo-controlled , crossover study , 22 healthy adults received placebo and 2 doses ( 250 and 500 mg ) of trans-resveratrol in counterbalanced order on separate days . After a 45-min resting absorption period , the participants performed a selection of cognitive tasks that activate the frontal cortex for an additional 36 min . Cerebral blood flow and hemodynamics , as indexed by concentration changes in oxygenated and deoxygenated hemoglobin , were assessed in the frontal cortex throughout the posttreatment period with the use of near-infrared spectroscopy . The presence of resveratrol and its conjugates in plasma was confirmed by HPLC after the same doses in a separate cohort ( n = 9 ) . RESULTS Resveratrol administration result ed in dose-dependent increases in cerebral blood flow during task performance , as indexed by total concentrations of hemoglobin . There was also an increase in deoxyhemoglobin after both doses of resveratrol , which suggested enhanced oxygen extraction , that became apparent toward the end of the 45-min absorption phase and was sustained throughout task performance . Cognitive function was not affected . Resveratrol metabolites were present in plasma throughout the cognitive task period . CONCLUSION These results showed that single doses of orally administered resveratrol can modulate cerebral blood flow variables Background —The Diabetes Atherosclerosis Intervention Study showed that treatment with fenofibrate decreases progression of coronary atherosclerosis in subjects with type 2 diabetes . We determined whether on-treatment plasma lipid concentrations and LDL particle size contribute to the favorable effect of fenofibrate on the progression of coronary artery disease ( CAD ) . Methods and Results —A total of OUTPUT: Statistically significant ( p < 0.05 ) positive effects , indicating that resveratrol supplementation was more effective than placebo/control , were identified for systolic blood pressure , hemoglobin A1c , and creatinine , but not for fasting glucose , homeostatic model assessment of insulin resistance , diastolic blood pressure , insulin , triglycerides , LDL , or HDL cholesterol . No major adverse events were reported and side effects of resveratrol were not different than placebo/control . Though limitations in sample size and treatment duration preclude definitive changes in clinical practice , significant improvements in multiple cardiometabolic biomarkers and an excellent safety profile support resveratrol as a leading c and i date as an adjunct to pharmacological management of T2DM INPUT: ABSTRACT Objective “ The obesity epidemic ” has led to an increase in obesity-related conditions including non-alcoholic fatty liver disease ( NAFLD ) , for which effective treatments are in dem and . The polyphenol resveratrol prevents the development of experimental NAFLD through modulation of cellular pathways involved in calorie restriction . We aim ed to test the hypothesis that resveratrol alleviates NAFLD in a r and omised , clinical trial . Material s and methods A total of 28 overweight patients with transaminasemia and histological NAFLD were r and omised 1:1 to placebo or resveratrol 1.5 g daily for 6 months . Twenty-six participants completed the trial and underwent repeated clinical investigation , blood work , MR spectroscopy ; and 19 participants agreed to a repeat liver biopsy . Results Resveratrol treatment was generally not superior to placebo in improving plasma markers of liver injury ( primary outcome : alanine transaminase , p = 0.51 ) . Resveratrol-treated patients showed a 3.8 % decrease in liver lipid content ( p = 0.03 ) , with no difference between the two treatment arms ( p = 0.38 ) and no improvement of histological features . Resveratrol treatment was not associated with improvements in insulin sensitivity or markers of the metabolic syndrome , except for a transient decrease in systolic BP . Microarray analysis and qRT-PCR revealed no major changes in expression profile . Also , we report a serious adverse event in a patient who developed fever and bicytopenia . Conclusions In this placebo-controlled , high-dose and long-term study , resveratrol treatment had no consistent therapeutic effect in alleviating clinical or histological NAFLD , though there may be a small ameliorating effect on liver function tests and liver fat accumulation Resveratrol is a naturally occurring polyphenolic compound . Numerous animal studies have been reported on its wide-ranging beneficial effects in the biological system including diabetes mellitus ( DM ) . We hypothesized , therefore , that oral supplementation of resveratrol would improve the glycemic control and the associated risk factors in patients with type 2 diabetes mellitus ( T2DM ) . The present clinical study was therefore carried out to test the hypothesis . Sixty-two patients with T2DM were enrolled from Government Headquarters Hospital , Ootacamund , India , in a prospect i ve , open-label , r and omized , controlled trial . Patients were r and omized into control and intervention groups . The control group received only oral hypoglycemic agents , whereas the intervention group received resveratrol ( 250 mg/d ) along with their oral hypoglycemic agents for a period of 3 months . Hemoglobin A(1c ) , lipid profile , urea nitrogen , creatinine , and protein were measured at the baseline and at the end of 3 months . The results reveal that supplementation of resveratrol for 3 months significantly improves the mean hemoglobin A(1c ) ( means ± SD , 9.99 ± 1.50 vs 9.65 ± 1.54 ; P < .05 ) , systolic blood pressure ( mean ± SD , 139.71 ± 16.10 vs 127.92 ± 15.37 ; P < .05 ) , total cholesterol ( mean ± SD , 4.70 ± 0.90 vs 4.33 ± 0.76 ; P < .05 ) , and total protein ( mean ± SD , 75.6 ± 4.6 vs 72.3 ± 6.2 ; P < .05 ) in T2DM . No significant changes in body weight and high-density lipoprotein and low-density lipoprotein cholesterols were observed . Oral supplementation of resveratrol is thus found to be effective in improving glycemic control and may possibly provide a potential adjuvant for the treatment and management of diabetes Resveratrol has been reported to have potent anti-atherosclerotic effects in animal studies . However , there are few interventional studies in human patients with atherosclerogenic diseases . The cardio-ankle vascular index ( CAVI ) reflects arterial stiffness and is a clinical surrogate marker of atherosclerosis . The aim of the present study was to investigate the effect of resveratrol on arterial stiffness assessed by CAVI in patients with type 2 diabetes mellitus (T2DM).In this double-blind , r and omized , placebo-controlled study , 50 patients with T2DM received supplement of a 100 mg resveratrol tablet ( total resveratrol : oligo-stilbene 27.97 mg/100 mg/day ) or placebo daily for 12 weeks . CAVI was assessed at baseline and the end of study . Body weight ( BW ) , blood pressure ( BP ) , glucose and lipid metabolic parameters , and diacron-reactive oxygen metabolites ( d-ROMs ; an oxidative stress marker ) were also measured . Resveratrol supplementation decreased systolic BP ( -5.5 ± 13.0 mmHg ) , d-ROMs ( -25.6 ± 41.8 U.CARR ) , and CAVI ( -0.4 ± 0.7 ) significantly ( P < 0.05 ) and decreased BW ( -0.8 ± 2.1 kg , P = 0.083 ) and body mass index ( -0.5 ± 0.8 kg/m2 , P = 0.092 ) slightly compared to baseline , while there were no significant changes in the placebo group . Decreases in CAVI and d-ROMs were significantly greater in the resveratrol group than in the placebo group . Multivariate logistic regression analysis identified resveratrol supplement OUTPUT:

Conclusion : The favourable effect of resveratrol emerging from the current meta- analysis suggests the possible use of this nutraceutical as active compound in order to promote cardiovascular health , mostly when used in high daily dose ( ≥300 mg/day ) and in diabetic patients

MS2_dynamic_1_shot35

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective : To determine whether falls can be prevented with minimally supervised exercise targeting potentially remediable fall risk factors , i.e. , poor balance , reduced leg muscle strength , and freezing of gait , in people with Parkinson disease . Methods : Two hundred thirty-one people with Parkinson disease were r and omized into exercise or usual-care control groups . Exercises were practice d for 40 to 60 minutes , 3 times weekly for 6 months . Primary outcomes were fall rates and proportion of fallers during the intervention period . Secondary outcomes were physical ( balance , mobility , freezing of gait , habitual physical activity ) , psychological ( fear of falling , affect ) , and quality -of-life measures . Results : There was no significant difference between groups in the rate of falls ( incidence rate ratio [ IRR ] = 0.73 , 95 % confidence interval [ CI ] 0.45–1.17 , p = 0.18 ) or proportion of fallers ( p = 0.45 ) . Preplanned subgroup analysis revealed a significant interaction for disease severity ( p < 0.001 ) . In the lower disease severity subgroup , there were fewer falls in the exercise group compared with controls ( IRR = 0.31 , 95 % CI 0.15–0.62 , p < 0.001 ) , while in the higher disease severity subgroup , there was a trend toward more falls in the exercise group ( IRR = 1.61 , 95 % CI 0.86–3.03 , p = 0.13 ) . Postintervention , the exercise group scored significantly ( p < 0.05 ) better than controls on the Short Physical Performance Battery , sit-to-st and , fear of falling , affect , and quality of life , after adjusting for baseline performance . Conclusions : An exercise program targeting balance , leg strength , and freezing of gait did not reduce falls but improved physical and psychological health . Falls were reduced in people with milder disease but not in those with more severe Parkinson disease . Classification of evidence : This study provides Class III evidence that for patients with Parkinson disease , a minimally supervised exercise program does not reduce fall risk . This study lacked the precision to exclude a moderate reduction or modest increase in fall risk from exercise . Trial registration : Australian New Zeal and Clinical Trials Registry ( ACTRN12608000303347 ) PURPOSE The purpose of this r and omized trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction for Breast Cancer ( MBSR[BC ] ) program in improving psychological and physical symptoms and quality of life among breast cancer survivors ( BCSs ) who completed treatment . Outcomes were assessed immediately after 6 weeks of MBSR(BC ) training and 6 weeks later to test efficacy over an extended timeframe . PATIENTS AND METHODS A total of 322 BCSs were r and omly assigned to either a 6-week MBSR(BC ) program ( n = 155 ) or a usual care group ( n = 167 ) . Psychological ( depression , anxiety , stress , and fear of recurrence ) and physical symptoms ( fatigue and pain ) and quality of life ( as related to health ) were assessed at baseline and at 6 and 12 weeks . Linear mixed models were used to assess MBSR(BC ) effects over time , and participant characteristics at baseline were also tested as moderators of MBSR(BC ) effects . RESULTS Results demonstrated extended improvement for the MBSR(BC ) group compared with usual care in both psychological symptoms of anxiety , fear of recurrence overall , and fear of recurrence problems and physical symptoms of fatigue severity and fatigue interference ( P < .01 ) . Overall effect sizes were largest for fear of recurrence problems ( d = 0.35 ) and fatigue severity ( d = 0.27 ) . Moderation effects showed BCSs with the highest levels of stress at baseline experienced the greatest benefit from MBSR(BC ) . CONCLUSION The MBSR(BC ) program significantly improved a broad range of symptoms among BCSs up to 6 weeks after MBSR(BC ) training , with generally small to moderate overall effect sizes Objective : To detect the effectiveness of incremental speed-dependent treadmill training on postural instability , dynamic balance and fear of falling in patients with idiopathic Parkinson 's disease . Design : R and omized controlled trial . Setting : Ankara Education and Research Hospital , 2nd PM&R Clinic , Cardiopulmonary Rehabilitation Unit . Subjects : Fifty-four patients with idiopathic Parkinson 's disease in stage 2 or 3 of the Hoehn Yahr staging entered , and 31 patients ( 21 training , 10 control ) had outcome data . Interventions : Postural instability of patients with Parkinson 's disease was assessed using the motor component of the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , Berg Balance Test , Dynamic Gait Index and Falls Efficacy Scale . Twenty-one patients with Parkinson 's disease participated in an eight-week exercise programme using incremental speed-dependent treadmill training . Before and after the training programme , balance , gait , fear of falling and walking distance and speed on treadmill were assessed in both Parkinson 's disease groups . Main measures : Walking distance and speed on treadmill , UPDRS , Berg Balance Test , Dynamic Gait Index and Falls Efficacy Scale . Results : Initial total walking distance of the training group on treadmill was 266.45 ± 82.14 m and this was progressively increased to 726.36 ± 93.1 m after 16 training session ( P < 0.001 ) . Tolerated maximum speed of the training group on treadmill at baseline was 1.9 ± 0.75 km/h and improved to 2.61 ± 0.77 km/h ( P < 0.001 ) . Berg Balance Test , Dynamic Gait Index and Falls Efficacy Scale scores of the training group were improved significantly after the training programme ( P < 0.01 ) . There OUTPUT: Results The data on psychotherapy ( CBT , third-wave CBT , and mindfulness ) , patient education , and rehabilitation programs demonstrated effectiveness in cancer and cardiac patients . Exercise interventions demonstrated effectiveness in patients with Parkinson ’s disease , and medical interventions showed limited effectiveness in reducing HA in diabetes and epilepsy . Conclusions The literature supports that a variety of interventions may be effective in reducing HA in individuals with chronic illness . INPUT: Objective : To determine whether falls can be prevented with minimally supervised exercise targeting potentially remediable fall risk factors , i.e. , poor balance , reduced leg muscle strength , and freezing of gait , in people with Parkinson disease . Methods : Two hundred thirty-one people with Parkinson disease were r and omized into exercise or usual-care control groups . Exercises were practice d for 40 to 60 minutes , 3 times weekly for 6 months . Primary outcomes were fall rates and proportion of fallers during the intervention period . Secondary outcomes were physical ( balance , mobility , freezing of gait , habitual physical activity ) , psychological ( fear of falling , affect ) , and quality -of-life measures . Results : There was no significant difference between groups in the rate of falls ( incidence rate ratio [ IRR ] = 0.73 , 95 % confidence interval [ CI ] 0.45–1.17 , p = 0.18 ) or proportion of fallers ( p = 0.45 ) . Preplanned subgroup analysis revealed a significant interaction for disease severity ( p < 0.001 ) . In the lower disease severity subgroup , there were fewer falls in the exercise group compared with controls ( IRR = 0.31 , 95 % CI 0.15–0.62 , p < 0.001 ) , while in the higher disease severity subgroup , there was a trend toward more falls in the exercise group ( IRR = 1.61 , 95 % CI 0.86–3.03 , p = 0.13 ) . Postintervention , the exercise group scored significantly ( p < 0.05 ) better than controls on the Short Physical Performance Battery , sit-to-st and , fear of falling , affect , and quality of life , after adjusting for baseline performance . Conclusions : An exercise program targeting balance , leg strength , and freezing of gait did not reduce falls but improved physical and psychological health . Falls were reduced in people with milder disease but not in those with more severe Parkinson disease . Classification of evidence : This study provides Class III evidence that for patients with Parkinson disease , a minimally supervised exercise program does not reduce fall risk . This study lacked the precision to exclude a moderate reduction or modest increase in fall risk from exercise . Trial registration : Australian New Zeal and Clinical Trials Registry ( ACTRN12608000303347 ) Purpose . To trial four-week 's physiotherapy targeting chair transfers for people with Parkinson 's disease ( PwPD ) and explore the feasibility of reliance on remote outcome measurement to preserve blinding . Scope . We recruited 47 PwPD and r and omised 24 to a focused home physiotherapy programme ( exercise , movement strategies , and cueing ) and 23 to a control group . We evaluated transfers ( plus mobility , balance , posture , and quality of life ) before and after treatment and at followup ( weeks 0 , 4 , 8 , and 12 ) from video produced by , and question naires distributed by , treating physiotherapists . Participants fed back via end-of- study question naires . Thirty-five participants ( 74 % ) completed the trial . Excluding dropouts , 20 % of question naire data and 9 % of video data were missing or unusable ; we had to evaluate balance in situ . We noted trends to improvement in transfers , mobility , and balance in the physiotherapy group not noted in the control group . Participant feedback was largely positive and assessor blinding was maintained in every case . Conclusions . Intense , focused physiotherapy at home appears acceptable and likely to bring positive change in those who can participate . Remote outcome measurement was successful ; question naire followup and further training in video production would reduce missing data . We advocate a fully powered trial , design ed to minimise dropouts and preserve assessor blinding , to evaluate this intervention Objectives : To determine whether 12-week home-based exergame step training can improve stepping performance , gait and complementary physical and neuropsychological measures associated with falls in Parkinson ’s disease . Design : A single-blinded r and omised controlled trial . Setting : Community ( experimental intervention ) , university laboratory ( outcome measures ) . Subjects : Sixty community-dwelling people with Parkinson ’s disease . Interventions : Home-based step training using videogame technology . Main measures : The primary outcomes were the choice stepping reaction time test and Functional Gait Assessment . Secondary outcomes included physical and neuropsychological measures associated with falls in Parkinson ’s disease , number of falls over six months and self-reported mobility and balance . Results : Post intervention , there were no differences between the intervention ( n = 28 ) and control ( n = 25 ) groups in the primary or secondary outcomes except for the Timed Up and Go test , where there was a significant difference in favour of the control group ( P = 0.02 ) . Intervention participants reported mobility improvement , whereas control participants reported mobility deterioration — between-group difference on an 11-point scale = 0.9 ( 95 % confidence interval : −1.8 to −0.1 , P = 0.03 ) . Interaction effects between intervention and disease severity on physical function measures were observed ( P = 0.01 to P = 0.08 ) with seemingly positive effects for the low-severity group and potentially negative effects for the high-severity group . Conclusion : Overall , home-based exergame step training was not effective in improving the outcomes assessed . However , the improved physical function in the lower disease severity intervention participants as well as the self-reported improved mobility in the intervention group suggest home-based exergame step training may have benefits for some people with Parkinson ’s disease BACKGROUND Poor locomotion and balance in Parkinson 's disease ( PD ) often diminishes independence . Accordingly , gait is considered one of the most relevant rehabilitation outcomes , and home-based balance exercises might be a viable mode of exercise delivery for individuals with PD . However , research on PD interventions rarely indicate best practice s to deliver exercises . Therefore , this study endeavoured to compare the efficacy of a home-based and therapist-supervised balance OUTPUT:

Home-based prescribed exercise improves balance-related activities and gait speed in people with Parkinson 's disease , and these improvements are similar to improvements with equivalent centre-based exercise .

MS2_dynamic_1_shot36

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background : In addition to lipid lowering , further pleotropic effects of statins have been postulated . We aim ed to study if the various pleotropic effects are due indirectly to the modulation of adipocytokines . Material s and methods : We studied the effect of atorvastatin on insulin sensitivity and the plasma adiponectin and leptin concentrations . Our r and omized open labeled study had 29 hyperlipidemic Type 2 diabetic patients ( 14 females , 15 males , mean age 60.0±2.2 yr ) . They were r and omized into three 12-week atorvastatin intervention types . Each day patients were given either 10 mg ( no.=10 ) , 20 mg ( no.=10 ) or 40 mg ( no.=9 ) . Evaluations were performed before and after intervention . Results : All baseline characteristics were statistically identical in the 3 groups . Drop in total cholesterol , LDL-cholesterol , and triglyceride levels were measured at the end . With 10 mg the drop was 30 % , 37 % , and 30 % . The 20 mg group was 43 % , 54 % , and 34 % . The 40 mg group was 42 % , 51 % , and 27 % . Groups had no significant change of body mass index , HDL-cholesterol , and glycated hemoglobin levels . Also , levels of insulin , adiponectin , leptin , homeostasis model assessment index ( HOMA ) and Quantitative Insulin Sensitivity Check Index ( QUICKI ) stayed the same . Pooled parameters of all 29 patients showed no difference in levels of insulin , adiponectin , leptin , HOMA , and QUICKI before and after treatment . Conclusions : Atorvstatin does not affect insulin sensitivity and the adiponectin or leptin levels in hyperlipidemic Type 2 diabetes INTRODUCTION Diabetes is a prothrombotic state involving a more thrombogenic fibrin network . In the present study we investigated the effects of lipid-lowering therapy with atorvastatin on fibrin network structure and platelet-derived microparticles in patients with type 1 diabetes and dyslipidemia . MATERIAL S AND METHODS Twenty patients were treated with atorvastatin ( 80 mg daily ) or placebo during 2 months in a r and omized , double-blind , cross-over study . Fibrin network permeability , expression of glycoprotein IIIa , P-selectin and tissue factor on platelet-derived microparticles , plasma endogenous thrombin potential , plasminogen activator inhibitor-1 and tissue plasminogen activator antigen levels were assessed . Additionally , levels of plasma fibrinogen , high-sensitivity C-reactive protein and glycated haemoglobin were measured . RESULTS During treatment with atorvastatin , fibrin network permeability increased ( p=0.01 ) , while endogenous thrombin potential and expression of glycoprotein IIIa , P-selectin and tissue factor decreased ( p<0.01 ) . In vitro experiments indicated that platelet-derived microparticles influence the fibrin network formation as fibrin network permeability decreased significantly when platelet-derived microparticles were added to normal plasma . Baseline levels of plasminogen activator inhibitor-1 and tissue plasminogen activator antigen as well as plasma fibrinogen and high-sensitivity C-reactive protein were within reference values and not significantly changed during atorvastatin treatment , while glycated haemoglobin increased 0.3 % ( p<0.001 ) . CONCLUSIONS Novel treatment effects were found in patients with type 1 diabetes and dyslipidemia during atorvastatin therapy , i.e. a more porous fibrin network , to which reduced expression of glycoprotein IIIa , P-selectin and tissue factor on platelet-derived microparticles may contribute . The observed impairment of glycemic control during long-term statin treatment deserves attention Summary Background The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome . No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic . Methods Of 19 342 hypertensive patients ( aged 40–79 years with at least three other cardiovascular risk factors ) r and omised to one of two antihypertensive regimens in the Anglo-Sc and inavian Cardiac Outcomes Trial , 10 305 with nonfasting total cholesterol concentrations 6.5 mmol/L or less were r and omly assigned additional atorvastatin 10 mg or placebo . These patients formed the lipid-lowering arm of the study . We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infa rct ion and fatal CHD . Data were analysed by intention to treat . Findings Treatment was stopped after a median follow-up of 3.3 years . By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50–0.83 ] , p = 0.0005 ) . This benefit emerged in the first year of follow-up . There was no significant heterogeneity among prespecified subgroups . Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56–0.96 ] , p = 0.024 ) , total cardiovascular events ( 389 vs 486 , 0.7 OUTPUT: Other studies showed that fasting plasma glucose and HbA1c levels were increased by atorvastatin . The majority of these articles showed that patients who used atorvastatin had a higher dose-dependent risk of developing NOD . Conclusion This systematic review suggests that there is an association between atorvastatin treatment and NOD . Moreover , it showed that atorvastatin in high dose causes worsening of the glycemic control in patients with DM INPUT: Obese AT ( adipose tissue ) exhibits increased macrophage number . Pro-inflammatory CD16 + peripheral monocyte numbers are also reported to increase with obesity . The present study was undertaken to simultaneously investigate obesity-associated changes in CD16 + monocytes and ATMs ( AT macrophages ) . In addition , a pilot r and omized placebo controlled trial using the PPAR ( peroxisome-proliferator-activated receptor ) agonists , pioglitazone and fenofibrate was performed to determine their effects on CD14+/CD16 + monocytes , ATM and cardiometabolic and adipose dysfunction indices . Obese glucose-tolerant men ( n=28 ) were r and omized to placebo , pioglitazone ( 30 mg/day ) and fenofibrate ( 160 mg/day ) for 12 weeks . A blood sample was taken to assess levels of serum inflammatory markers and circulating CD14+/CD16 + monocyte levels via flow cytometry . A subcutaneous AT biopsy was performed to determine adipocyte cell surface and ATM number , the latter was determined via assessment of CD68 expression by IHC ( immunohistochemistry ) and real-time PCR . Subcutaneous AT mRNA expression of CEBPβ ( CCAAT enhancer-binding protein β ) , SREBP1c ( sterol-regulatory-element-binding protein 1c ) , PPARγ2 , IRS-1 ( insulin receptor substrate-1 ) , GLUT4 ( glucose transporter type 4 ) and TNFα ( tumour necrosis factor α ) were also assessed . Comparisons were made between obese and lean controls ( n=16 ) at baseline , and pre- and post-PPAR agonist treatment . Obese individuals had significantly increased adipocyte cell surface , percentage CD14+/CD16 + monocyte numbers and ATM number ( all P=0.0001 ) . Additionally , serum TNF-α levels were significantly elevated ( P=0.017 ) and adiponectin levels reduced ( total : P=0.0001 ; high : P=0.022 ) with obesity . ATM number and percentage of CD14+/CD16 + monocytes correlated significantly ( P=0.05 ) . Pioglitazone improved adiponectin levels significantly ( P=0.0001 ) , and result ed in the further significant enlargement of adipocytes ( P=0.05 ) , without effect on the percentage CD14+/CD16 + or ATM number . Pioglitazone treatment also significantly increased subcutaneous AT expression of CEBPβ mRNA . The finding that improvements in obesity-associated insulin resistance following pioglitazone were associated with increased adipocyte cell surface and systemic adiponectin levels , supports the central ity of AT to the cardiometabolic derangement underlying the development of T2D ( Type 2 diabetes ) and CVD ( cardiovascular disease ) The insulin-sensitizing effects of thiazolidinediones are thought to be mediated through peroxisome proliferator-activated receptor-gamma , a nuclear receptor that is highly abundant in adipose tissue . It has been reported that adipocytes secrete a variety of proteins , including tumor necrosis factor-alpha , resistin , plasminogen activator inhibitor-1 , and adiponectin . Adiponectin is a fat cell-secreted protein that has been reported to increase fat oxidation and improve insulin sensitivity . Our aim was to study the effects of troglitazone on adiponectin levels in lean , obese , and diabetic subjects . Ten diabetic and 17 nondiabetic subjects ( 8 lean , BMI < 27 kg/m(2 ) and 9 obese , BMI > 27 kg/m(2 ) ) participated in the study . All subjects underwent an 80 mU. m(-2 ) . min(-1 ) hyperinsulinemic-euglycemic glucose clamp before and after 3 months ' treatment with the thiazolidinedione ( TZD ) troglitazone ( 600 mg/day ) . Fasting plasma glucose significantly decreased in the diabetic group after 12 weeks of treatment compared with baseline ( 9.1 + /- 0.9 vs. 11.1 + /- 0.9 mmol/l , P < 0.005 ) but was unchanged in the lean and obese subjects . Fasting insulin for the entire group was significantly lower than baseline ( P = 0.02 ) after treatment . At baseline , glucose disposal rate ( R(d ) ) was lower in the diabetic subjects ( 3.4 + /- 0.5 mg . kg(-1 ) . min(-1 ) ) than in the lean ( 12.3 + /- 0.4 ) or obese subjects ( 6.7 + /- 0.7 ) ( P < 0.001 for both ) and was significantly improved in the diabetic and obese groups ( P < 0.05 ) after treatment , and it remained unchanged in the lean subjects . Baseline adiponectin levels were significantly lower in the diabetic than the lean subjects ( 9.0 + /- 1.7 vs. 16.7 + /- 2.7 micro g/ml , P = 0.03 ) and rose uniformly in all subjects ( 12.2 + /- 2.3 vs. 25.7 + /- 2.6 micro g/ml , P < 10(-4 ) ) after treatment , with no significant difference detected among the three groups . During the glucose clamps , adiponectin levels were suppressed below basal levels in all groups ( 10.2 + /- 2.3 vs. 12.2 + /- 2.3 micro g/ml , P < 0.01 ) . Adiponectin levels correlated with R( OUTPUT:

The observed effect was robust in sensitivity analyses and independent of fibrate dose . The present meta- analysis suggests that fibrate therapy increases circulating levels of adiponectin .

MS2_dynamic_1_shot37

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people . Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures , as proved by Decalyos I. Decalyos II is a 2-year , multicenter , r and omized , double-masked , placebo-controlled confirmatory study . The intention-to-treat population consisted of 583 ambulatory institutionalized women ( mean age 85.2 years , SD = 7.1 ) r and omized to the calcium – vitamin D3 fixed combination group ( n= 199 ) ; the calcium plus vitamin D3 separate combination group ( n= 190 ) and the placebo group ( n= 194 ) . Fixed and separate combination groups received the same daily amount of calcium ( 1200 mg ) and vitamin D3 ( 800 IU ) , which had similar pharmacodynamic effects . Both types of calcium-vitamin D3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent , with levels returning within the normal range after 6 months . In a subgroup of 114 patients , femoral neck bone mineral density ( BMD ) decreased in the placebo group ( mean = –2.36 % per year , SD = 4.92 ) , while remaining unchanged in women treated with calcium-vitamin D3 ( mean = 0.29 % per year , SD = 8.63 ) . The difference between the two groups was 2.65 % ( 95 % CI = –0.44 , 5.75 % ) with a trend in favor of the active treatment group . No significant difference between groups was found for changes in distal radius BMD and quantitative ultrasonic parameters at the os calcis . The relative risk ( RR ) of HF in the placebo group compared with the active treatment group was 1.69 ( 95 % CI = 0.96 , 3.0 ) , which is similar to that found in Decalyos I ( RR = 1.7 ; 95 % CI = 1.0 , 2.8 ) . Thus , these data are in agreement with those of Decalyos I and indicate that calcium and vitamin D3 in combination reverse senile secondary hyperparathyroidism and reduce both hip bone loss and the risk of hip fracture in elderly institutionalized women RATIONALE Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis . OBJECTIVES To test whether vitamin D supplementation of patients with tuberculosis ( TB ) improved clinical outcome and reduced mortality . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau . We included 365 adult patients with TB starting antituberculosis treatment ; 281 completed the 12-month follow-up . The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment . MEASUREMENTS AND MAIN RESULTS The primary outcome was reduction in a clinical severity score ( TBscore ) for all patients with pulmonary TB . The secondary outcome was 12-month mortality . No serious adverse effects were reported ; mild hypercalcemia was rare and present in both arms . Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo . Overall mortality was 15 % ( 54 of 365 ) at 1 year of follow-up and similar in both arms ( 30 of 187 for vitamin D treated and 24 of 178 for placebo ; relative risk , 1.19 [ 0.58 - 1.95 ] ) . HIV infection was seen in 36 % ( 131 of 359 ) : 21 % ( 76 of 359 ) HIV-1 , 10 % ( 36 of 359 ) HIV-2 , and 5 % ( 19 of 357 ) HIV-1 + 2 . CONCLUSIONS Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB ; it is possible that the dose used was insufficient . Clinical trial registered with www.controlled-trials.com/is rct n ( IS RCT N35212132 ) BACKGROUND Adequate calcium intake can have a favorable effect on some metabolic variables . OBJECTIVE The objective of the study was to determine the effects of daily calcium intake and of supplementation with calcium and vitamin D ( calcium+D ) during a weight-loss intervention on blood pressures , plasma lipid and lipoprotein concentrations , and glucose and insulin concentrations in low calcium consumers . DESIGN Healthy , overweight or obese women ( n = 63 ) with a daily calcium intake of < 800 mg/d were r and omly assigned in a double-blind manner to 1 of 2 groups : the group consuming 2 tablets/d of a calcium + vitamin D supplement ( 600 mg elemental calcium and 200 IU vitamin D/tablet ) or the group consuming placebo ; both groups observed a 700 kcal/d energy restriction . These 63 women then completed a 15-wk weight-loss intervention . RESULTS Initial daily calcium intake was significantly correlated with plasma HDL cholesterol ( r = 0.41 , P < 0.001 ) and with 2-h postload glycemia ( r = -0.29 , P < 0.05 ) during an oral-glucose-tolerance test , independent of fat mass and waist circumference . After the 15-wk inter OUTPUT: There were no significant changes in the surrogate outcomes of lipid fractions , glucose , or diastolic or systolic blood pressure . INPUT: Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people . Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures , as proved by Decalyos I. Decalyos II is a 2-year , multicenter , r and omized , double-masked , placebo-controlled confirmatory study . The intention-to-treat population consisted of 583 ambulatory institutionalized women ( mean age 85.2 years , SD = 7.1 ) r and omized to the calcium – vitamin D3 fixed combination group ( n= 199 ) ; the calcium plus vitamin D3 separate combination group ( n= 190 ) and the placebo group ( n= 194 ) . Fixed and separate combination groups received the same daily amount of calcium ( 1200 mg ) and vitamin D3 ( 800 IU ) , which had similar pharmacodynamic effects . Both types of calcium-vitamin D3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent , with levels returning within the normal range after 6 months . In a subgroup of 114 patients , femoral neck bone mineral density ( BMD ) decreased in the placebo group ( mean = –2.36 % per year , SD = 4.92 ) , while remaining unchanged in women treated with calcium-vitamin D3 ( mean = 0.29 % per year , SD = 8.63 ) . The difference between the two groups was 2.65 % ( 95 % CI = –0.44 , 5.75 % ) with a trend in favor of the active treatment group . No significant difference between groups was found for changes in distal radius BMD and quantitative ultrasonic parameters at the os calcis . The relative risk ( RR ) of HF in the placebo group compared with the active treatment group was 1.69 ( 95 % CI = 0.96 , 3.0 ) , which is similar to that found in Decalyos I ( RR = 1.7 ; 95 % CI = 1.0 , 2.8 ) . Thus , these data are in agreement with those of Decalyos I and indicate that calcium and vitamin D3 in combination reverse senile secondary hyperparathyroidism and reduce both hip bone loss and the risk of hip fracture in elderly institutionalized women Background —Low 25-hydroxyvitamin D levels , commonly found in older patients with heart failure , may contribute to the chronic inflammation and skeletal myopathy that lead to poor exercise tolerance . We tested whether vitamin D supplementation of patients with heart failure and vitamin D insufficiency can improve physical function and quality of life . Methods and Results —In a r and omized , parallel group , double-blind , placebo-controlled trial , patients with systolic heart failure aged ≥70 years with 25-hydroxyvitamin D levels < 50 nmol/L ( 20 ng/mL ) received 100000 U of oral vitamin D2 or placebo at baseline and 10 weeks . Outcomes measured at baseline , 10 weeks , and 20 weeks were 6-minute walk distance , quality of life ( Minnesota score ) , daily activity measured by accelerometry , Functional Limitations Profile , B-type natriuretic peptide , and tumor necrosis factor-&agr;. Participants in the vitamin D group had an increase in their 25-hydroxyvitamin D levels compared with placebo at 10 weeks ( 22.9 versus 2.3 nmol/L [ 9.2 versus 0.9 ng/mL ] ; P<0.001 ) and maintained this increase at 20 weeks . The 6-minute walk did not improve in the treatment group relative to placebo . No significant benefit was seen on timed up and go testing , subjective measures of function , daily activity , or tumor necrosis factor . Quality of life worsened by a small , but significant amount in the treatment group relative to placebo . B-type natriuretic peptide decreased in the treatment group relative to placebo ( −22 versus + 78 pg/mL at 10 weeks ; P=0.04 ) . Conclusions —Vitamin D supplementation did not improve functional capacity or quality of life in older patients with heart failure with vitamin D insufficiency . Clinical Trial Registration —www.controlled-trials.com . Identifier : IS RCT N51372896 BACKGROUND Despite considerable interest , the relationship between circulating 25-hydroxyvitamin D and the risk of hip fracture is not fully established . OBJECTIVE The objective of the study was to study the association between serum 25-hydroxyvitamin D concentrations [ s-25(OH)D ] and the risk of hip fracture in Norway , a high-latitude country that has some of the highest hip fracture rates worldwide . METHODS A total of 21 774 men and women aged 65 - 79 years attended 4 community-based health studies during 1994 - 2001 . Information on subsequent hip fractures was retrieved from electronic hospital discharge registers , with a maximum follow-up of 10.7 years . Using a stratified case-cohort design , s-25(OH)D was determined by HPLC-atmospheric pressure chemical ionization-mass spectrometry in stored serum sample s in hip fracture cases ( n = 1175 ; 307 men , 868 women ) and in gender-stratified r and om sample s ( n = 1438 ) . Cox proportional hazards regression adapted for the case-cohort design was performed . RESULTS We observed an inverse association between s-25(OH)D and hip fracture ; those with s-25(OH)D in the lowest quartile ( < 42.2 nmol/L ) had OUTPUT:

Conclusions and Relevance In this systematic review and meta- analysis , neither intermittent nor daily dosing with st and ard doses of vitamin D alone was associated with reduced risk of fracture , but daily supplementation with both vitamin D and calcium was a more promising strategy

MS2_dynamic_1_shot38

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: In a prospect i ve trial , 222 adults with low-back pain of at least 2 weeks ' duration in a Health Maintenance Organization ( HMO ) were r and omly assigned to usual care ( UC ) , a 4-hour back school psychoeducational session ( LBS ) , or the same back school plus a 1-year “ compliance package ” program design ed to encourage appropriate self-management for back pain ( CP ) . Sixty-four percent of LBS and CP subjects attended their back school sessions . Follow-up measurement of pain level ( using the Visual Analogue Scale ) , functional status ( using the Sickness Impact Profile ) , and various other indicators of health status showed no measurable effect of either treatment condition ( LBS or CP ) compared with UC at 3 , 6 , 12 , and 18 months after entry into the study . Initial disability resolved by 3 months in most patients , and a minority of subjects ( 10–15 % ) showed residual or recurrent functional Impairment 1 year after entry . Health care utilization tended to be slightly higher after intervention In the CP group . With or without follow-up encouragement , back school instructions given in a single 4-hour session had no measurable impact on the comfort or functional status of the majority of patients with new onset back pain in this HMO Design . R and omized prospect i ve study of the effects of three types of active therapy on back muscle function in chronic low back pain patients . Objectives . To quantify the effects of 3 months active therapy on strength , endurance , activation , and fatigability of the back entensor muscles . Summary of Background Data . Many studies have documented an association between chronic low back pain and diminished muscular performance capacity . Few studies have quantified the changes in these measures following interventions using objective measurement techniques or related them to changes in clinical outcome . Methods . A total of 148 individuals ( 57 % women ) with chronic low back pain ( age , 45.0 ± 10.0 years ; duration of low back pain , 10.9 ± 9.5 years ) were r and omized to a treatment that they attended for 3 months : active physiotherapy , muscle reconditioning on devices , or low-impact aerobics . Before and after therapy , assessment s were made of the following : trunk muscle strength ( in flexion , extension , lateral bending , and axial rotation ) , erector spinae activation ( maximal , and during forward bending movements ) , back extensor endurance ( Biering-S/orensen test ) , and erector spinae fatigability ( determined from changes in the median frequency of the surface electromyographic signal ) during isometric and dynamic tests . Results . A total of 132 of 148 patients ( 89 % ) completed the therapy . Isometric strength in each movement direction increased in all groups post-therapy ( P < 0.0008 ) , most notably in the devices group . Activation of the erector spinae during the extension tests also increased significantly in all groups and showed a weak , but significant , relationship with increased maximal strength ( P = 0.01 ) . Pretherapy 55 % of the subjects showed no relaxation of the back muscles at L5 when in the fully flexed position ; no changes were observed in any group post-therapy . Endurance time during the Biering-S/orensen test increased significantly post-therapy in all groups ( P = 0.0001 ) , but there were no significant changes in EMG-determined fatigability . Fatigability of the lumbar muscles at L5 ( EMG median frequency changes ) during the dynamic test increased post-therapy ( P = 0.0001 ) without group differences . Conclusion . Significant changes in muscle performance were observed in all three active therapy groups post-therapy , which appeared to be mainly due to changes in neural activation of the lumbar muscles and psychological changes concerning , for example , motivation or pain tolerance The purpose of this study was to assess the effects of two different treatment modalities on the rehabilitation process of chronic sacroiliac joint patients . The treatment modalities included spinal manipulative therapy given by a chiropractor and a program of back school therapy given by a physiotherapist . The rehabilitation process was assessed using clinical and biomechanical measures . It was found that back school therapy was a better treatment modality than the spinal manipulative therapy , according to the clinical measures of rehabilitation . Precisely the opposite result was found for the biomechanical measures This study investigated the effect of a back school rehabilitation program on lost work time , lost time cost , medical cost , and number of injuries in municipal employees . Seventy back-injured workers who participated in a 6-week back school were compared on the dependent variables with 70 r and omly selected back-injured city employees who had not participated in a back school . Back school participants demonstrated a significant decrease on all dependent variables . Back school participants had significantly fewer injuries in the 6-month postintervention period . No statistically significant differences were found between groups on the time and cost variables . Actual dollars saved in lost time and medical costs between groups was of practical value to the city . Study findings offer support for the back school as a cost-effective measure A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL OUTPUT: The results indicate that there is moderate evidence that back schools have better short-term effects than other treatments for chronic low back pain , and that there is moderate evidence that back schools in an occupational setting are more effective compared to ' placebo ' or waiting list controls . REVIEW ER 'S CONCLUSIONS Back schools may be effective for patients with recurrent and chronic low back pain in occupational setting s , but little is known about the cost-effectiveness of back schools INPUT: A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL sessions . Further research is needed to answer the question of “ intensity versus type of exercise ” by comparing different intervention programs , with similar intensity The effects of two different prevention programmes on : ( 1 ) reported neck , shoulder and back pain , ( 2 ) perceived physical exertion at work and perceived work-related psychosocial factors , were evaluated by question naires after 12 and 18 months . Female nursing aides and assistant nurses ( n = 282 ) working in the home-care services , were r and omly assigned to one of three groups for : ( 1 ) individually design ed physical training programme , ( 2 ) work-place stress management , ( 3 ) control group . Results revealed no significant differences between the three groups . However , improvements in low back pain were registered within both intervention groups for up to 18 months . Perceived physical exertion at work was reduced in the physical training group . Improvements in neck and shoulder pain did not differ within the three groups . Dissatisfaction with work-related , psychosocial factors was generally increased in all groups . As the aetiology of neck , shoulder and back disorders is multifactorial , a combination of the two intervention programmes might be preferable and should be further studied CONTEXT Low back pain is a frequent and costly health problem . Prevention of low back pain is important both for the individual patient and from an economic perspective . OBJECTIVE To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry . DESIGN A r and omized controlled trial with a factorial design . SETTING The cargo department of an airline company in the Netherl and s. PARTICIPANTS A total of 312 workers were r and omized , of whom 282 were available for the 6-month follow-up . INTERVENTIONS Subjects were r and omly assigned to 4 groups : ( 1 ) education ( lifting instructions ) and lumbar support , ( 2 ) education , ( 3 ) lumbar support , and ( 4 ) no intervention . Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours . Lumbar supports were recommended to be used during working hours for 6 months . MAIN OUTCOME MEASURES Low back pain incidence and sick leave because of back pain during the 6-month intervention period . RESULTS Compliance with wearing the lumbar support at least half the time was 43 % . In the 282 subjects for whom data were available , no statistically significant differences in back pain incidence ( 48 [ 36 % ] of 134 with lumbar support vs 51 [ 34 % ] of 148 without , P=.81 ) or in sick leave because of low back pain ( mean , 0.4 days per month with lumbar support vs 0.4 days without , P=.52 ) were found among the intervention groups . In a subgroup of subjects with low back pain at baseline , lumbar supports reduced the number of days with low back pain per month ( median , 1.2 vs 6.5 days per month ; P=.03 ) . CONCLUSIONS Overall , lumbar supports or education did not lead to a reduction in low back pain incidence or sick leave . The results of the subgroup analysis need to be confirmed by future research . Based on our results , the use of education or lumbar supports can not be recommended in the prevention of low back pain in industry STUDY DESIGN A systematic review of r and omized and nonr and omized controlled trials . SUMMARY OF BACKGROUND DATA Lumbar supports are used in the treatment of low back pain , but also to prevent the onset ( primary prevention ) or recurrences of a low back pain episode ( secondary prevention ) . OBJECTIVES To assess the effects of lumbar sup-ports for prevention and treatment of nonspecific low back pain . METHODS The Medline , Cinahl , and Current Contents data bases ; the Cochrane Controlled Trials Register up to September 1999 ; and the Embase data base up to September 1998 were all search ed . References of identified trials and systematic review s were review ed and the Science Citation Index used to identify additional trials . Method ologic quality assessment and data extraction were performed by two review ers independently . A quantitative analysis was performed in which the strength of evidence was classified as strong , moderate , limited or conflicting , and no evidence . RESULTS Five r and omized and two nonr and omized preventive trials and six r and omized therapeutic trials were included in the review . Only 4 of the 13 studies were of high quality . There was moderate evidence that lumbar supports are not effective for primary prevention . No evidence was found on the effectiveness of lumbar supports for secondary prevention . The systematic review of therapeutic trials showed that there is limited evidence that lumbar supports are more effective than no treatment , whereas it is still unclear whether lumbar supports are more effective than other interventions for treatment of low back pain . CONCLUSIONS There continues to be a need for high quality r and omized trials on the effectiveness of lumbar supports . One of the most essential issues to tackle in these future trials seems to be the realization of adequate compliance This study was funded in part by NIH grant AR36308 The authors thank the employees OUTPUT:

Since three of four RCTs on lumbar supports reported no effect , there is no evidence for the effectiveness of lumbar supports . The four RCTs on exercise consistently reported a positive effect , indicating limited evidence for the effectiveness of exercise . CONCLUSION There is no evidence for the effectiveness of lumbar supports or education in the primary prevention of low back pain at the workplace . There is limited evidence for the efficacy of exercise , and the effect that can be obtained is moderate .

MS2_dynamic_1_shot39

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year OBJECTIVE —The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practice s. RESEARCH DESIGN AND METHODS —This was a group-r and omized , controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention ( TRANSLATE ) in 24 practice s. The intervention included implementation of an electronic diabetes registry , visit reminders , and patient-specific physician alerts . A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion . The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure ( SBP ) < 130 mmHg , LDL cholesterol < 100 mg/dl , and A1C < 7.0 % at baseline and 12 months . Six process measures were also followed . RESULTS —Over 24 months , 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practice s from 17 health systems . Diabetes process measures increased significantly more in intervention than in control practice s , giving net increases as follows : foot examinations 35.0 % ( P < 0.0.001 ) ; annual eye examinations 25.9 % ( P < 0.001 ) ; renal testing 28.5 % ( P < 0.001 ) ; A1C testing 8.1%(P < 0.001 ) ; blood pressure monitoring 3.5 % ( P = 0.05 ) ; and LDL testing 8.6 % ( P < 0.001 ) . Mean A1C adjusted for age , sex , and comorbidity decreased significantly in intervention practice s ( P < 0.02 ) . At 12 months , intervention practice s had significantly greater improvement in achieving recommended clinical values for SBP , A1C , and LDL than control clinics ( P = 0.002 ) . CONCLUSIONS — Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes BACKGROUND Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits . METHODS We conducted a r and omized controlled trial of a 12-month intervention at 2 large community health centers , enrolling 310 patients with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 25 or greater . In the intervention group , self-management goals for nutrition and physical activity were set using a tailored computer program . Goals were then review ed at each clinic visit by physicians . The control group received only printed health education material s. The main outcome measures included change in physical activity and body weight . RESULTS In the intervention group , recommended levels of physical activity increased from 26 % at baseline to 53 % at 12 months ( P < .001 ) compared with controls ( 30 % to 37 % ; P= .27 ) , and 32 % of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9 % of controls ( odds ratio , 2.2 ; P= .006 ) . CONCLUSION A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss Purpose : Physicians and patients frequently miss opportunities to improve the quality of care of diabetes , primarily because of the complexity of managing many risk factors over many years with many other providers . Electronic decision support is a potential way to improve prescribing and quality of care . Shared care , meaning patients and physicians sharing access to the patient ’s status compared to recommended targets , is thought to improve outcomes as are supportive reminders . Our objective was to rigorously evaluate whether an electronic medical record (EMR)-linked , individualized electronic diabetes tracker with automated telephone reminders could improve the quality of di OUTPUT: Triglycerides and practitioner performance tended to favour computerized clinical decision support systems although results were too heterogeneous to pool . INPUT: OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with st and ard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A cluster-r and omized clinical trial , the Mobile Diabetes Intervention Study , r and omly assigned 26 primary care practice s to one of three stepped treatment groups or a control group ( usual care ) . A total of 163 patients were enrolled and included in analysis . The primary outcome was change in glycated hemoglobin levels over a 1-year treatment period . Secondary outcomes were changes in patient-reported diabetes symptoms , diabetes distress , depression , and other clinical ( blood pressure ) and laboratory ( lipid ) values . Maximal treatment was a mobile- and web-based self-management patient coaching system and provider decision support . Patients received automated , real-time educational and behavioral messaging in response to individually analyzed blood glucose values , diabetes medications , and lifestyle behaviors communicated by mobile phone . Providers received quarterly reports summarizing patient ’s glycemic control , diabetes medication management , lifestyle behaviors , and evidence -based treatment options . RESULTS The mean declines in glycated hemoglobin were 1.9 % in the maximal treatment group and 0.7 % in the usual care group , a difference of 1.2 % ( P = 0.001 ) over 12 months . Appreciable differences were not observed between groups for patient-reported diabetes distress , depression , diabetes symptoms , or blood pressure and lipid levels ( all P > 0.05 ) . CONCLUSIONS The combination of behavioral mobile coaching with blood glucose data , lifestyle behaviors , and patient self-management data individually analyzed and presented with evidence -based guidelines to providers substantially reduced glycated hemoglobin levels over 1 year BACKGROUND Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits . METHODS We conducted a r and omized controlled trial of a 12-month intervention at 2 large community health centers , enrolling 310 patients with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 25 or greater . In the intervention group , self-management goals for nutrition and physical activity were set using a tailored computer program . Goals were then review ed at each clinic visit by physicians . The control group received only printed health education material s. The main outcome measures included change in physical activity and body weight . RESULTS In the intervention group , recommended levels of physical activity increased from 26 % at baseline to 53 % at 12 months ( P < .001 ) compared with controls ( 30 % to 37 % ; P= .27 ) , and 32 % of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9 % of controls ( odds ratio , 2.2 ; P= .006 ) . CONCLUSION A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss OBJECTIVE To improve quality and efficiency of care for elderly patients with type 2 diabetes , we introduced elderly-friendly strategies to the clinical decision support system (CDSS)-based ubiquitous healthcare ( u-healthcare ) service , which is an individualized health management system using advanced medical information technology . RESEARCH DESIGN AND METHODS We conducted a 6-month r and omized , controlled clinical trial involving 144 patients aged > 60 years . Participants were r and omly assigned to receive routine care ( control , n = 48 ) , to the self-monitored blood glucose ( SMBG , n = 47 ) group , or to the u-healthcare group ( n = 49 ) . The primary end point was the proportion of patients achieving A1C < 7 % without hypoglycemia at 6 months . U-healthcare system refers to an individualized medical service in which medical instructions are given through the patient ’s mobile phone . Patients receive a glucometer with a public switched telephone network-connected cradle that automatically transfers test results to a hospital-based server . Once the data are transferred to the server , an automated system , the CDSS rule engine , generates and sends patient-specific messages by mobile phone . RESULTS After 6 months of follow-up , the mean A1C level was significantly decreased from 7.8 ± 1.3 % to 7.4 ± 1.0 % ( P < 0.001 ) in the u-healthcare group and from 7.9 ± 1.0 % to 7.7 ± 1.0 % ( P = 0.020 ) in the SMBG group , compared with 7.9 ± 0.8 % to 7.8 ± 1.0 % ( P = 0.274 ) in the control group . The proportion of patients with A1C < 7 % without hypoglycemia was 30.6 % in the u-healthcare group , 23.4 % in the SMBG group ( 23.4 % ) , and 14.0 % in the control group ( P < 0.05 ) . CONCLUSIONS The CDSS-based u-healthcare service achieved better glycemic control with less hypoglycemia than SMBG and routine care and may provide effective and safe diabetes management in the elderly diabetic patients PURPOSE The Women to Women Diabetes Project tested the use of telecommunication technology to deliver diabetes education and social support to rural women with diabetes . The aims were to ( 1 ) test the effects of the computer intervention in providing support , information , and education on selected outcomes , and ( 2 ) evaluate the women 's attitudes toward and satisfaction with the intervention and the support provided . METHODS Thirty women were r and omized into computer and noncomputer groups and participated for 10 months . OUTPUT:

There was no evidence of improvement in depression , quality of life , blood pressure , serum lipids , or weight . There was no evidence of significant adverse effects . CONCLUSIONS Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control , and this effect was larger in the mobile phone subgroup . There was no evidence of benefit for other biological , cognitive , behavioral , or emotional outcomes

MS2_dynamic_1_shot40

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives —To undertake a prospect i ve epidemiological study of the injuries sustained in English professional football over two competitive seasons . Methods —Player injuries were annotated by club medical staff at 91 professional football clubs . A specific injury audit question naire was used together with a weekly form that documented each club 's current injury status . Results —A total of 6030 injuries were reported over the two seasons with an average of 1.3 injuries per player per season . The mean ( SD ) number of days absent for each injury was 24.2 ( 40.2 ) , with 78 % of the injuries leading to a minimum of one competitive match being missed . The injury incidence varied throughout the season , with training injuries peaking during July ( p<0.05 ) and match injuries peaking during August ( p<0.05 ) . Competition injuries represented 63 % of those reported , significantly ( p<0.01 ) more of these injuries occurring towards the end of both halves . Strains ( 37 % ) and sprains ( 19 % ) were the major injury types , the lower extremity being the site of 87 % of the injuries reported . Most injury mechanisms were classified as being non-contact ( 58 % ) . Re-injuries accounted for 7 % of all injuries , 66 % of these being classified as either a strain or a sprain . The severity of re-injuries was greater than the initial injury ( p<0.01 ) . Conclusions —Professional football players are exposed to a high risk of injury and there is a need to investigate ways of reducing this risk . Areas that warrant attention include the training programmes implemented by clubs during various stages of the season , the factors contributing to the pattern of injuries during matches with respect to time , and the rehabilitation protocol s employed by clubs Background The injury risk in football is high , but little is known about causes of injury . Purpose To identify risk factors for football injuries using a multivariate model . Study Design Prospect i ve cohort study . Methods Participants were 306 male football players from the two highest divisions in Icel and . Before the 1999 football season started , the following factors were examined : height , weight , body composition , flexibility , leg extension power , jump height , peak O2 uptake , joint stability , and history of previous injury . Injuries and player exposure were recorded throughout the competitive season . Results Older players were at higher risk of injury in general ( odds ratio [ OR ] = 1.1 per year , P = 0.05 ) . For hamstring strains , the significant risk factors were age ( OR = 1.4 [ 1 year ] , P < 0.001 ) and previous hamstring strains ( OR = 11.6 , P < 0.001 ) . For groin strains , the predictor risk factors were previous groin strains ( OR = 7.3 , P = 0.001 ) and decreased range of motion in hip abduction ( OR = 0.9 [ 1 ° ] , P = 0.05 ) . Previous injury was also identified as a risk factor for knee ( OR = 4.6 ) and ankle sprains ( OR = 5.3 ) . Conclusions Age and previous injury were identified as the main risk factors for injury among elite football players from Icel and Objective To study the injury characteristics in professional football and to follow the variation of injury incidence during a match , during a season and over consecutive seasons . Design Prospect i ve cohort study where teams were followed for seven consecutive seasons . Team medical staff recorded individual player exposure and time-loss injuries from 2001 to 2008 . Setting European professional men 's football . Participants The first team squads of 23 teams selected by the Union of European Football Associations as belonging to the 50 best European teams . Main outcome measurement Injury incidence . Results 4483 injuries occurred during 566 000 h of exposure , giving an injury incidence of 8.0 injuries/1000 h. The injury incidence during matches was higher than in training ( 27.5 vs 4.1 , p<0.0001 ) . A player sustained on average 2.0 injuries per season , and a team with typically 25 players can thus expect about 50 injuries each season . The single most common injury subtype was thigh strain , representing 17 % of all injuries . Re-injuries constituted 12 % of all injuries , and they caused longer absences than non re-injuries ( 24 vs 18 days , p<0.0001 ) . The incidence of match injuries showed an increasing injury tendency over time in both the first and second halves ( p<0.0001 ) . Traumatic injuries and hamstring strains were more frequent during the competitive season , while overuse injuries were common during the preseason . Training and match injury incidences were stable over the period with no significant differences between seasons . Conclusions The training and match injury incidences were stable over seven seasons . The risk of injury increased with time in each half of matches Objectives : To undertake a detailed epidemiological study of training injuries sustained by professional rugby union players in order to define their incidence , nature , severity , and causes . Methods : A two season prospect i ve design was used to study training injuries associated with 502 rugby union players at 11 English Premiership clubs . Team clinicians reported all training injuries on a weekly basis and provided details of the location , diagnosis , severity , and mechanism of each injury . Training exposures for individual players were recorded on a weekly basis . Loss of time from training and match play was used as the definition of an injury . Results : The overall incidence of injury was 2.0 per 1000 player-hours , and each injury result ed on average in 24 days lost time . Recurrences , which accounted for 19 % of injuries , were more severe ( 35 days ) than new injuries ( 21 days ) . Twenty two per cent of all training occurred during the preseason but 34 % of all injuries were sustained in this period . Hamstring , calf , hip flexor/quadriceps , and adductor muscle injuries were the most common for OUTPUT: The conventional hamstring to quadricep strength ratios were also reduced well after return to play ( 60:60 ° /s , d=-0.32 ; 240:240 ° /s , d=-0.43 ) and functional ( 30:240 ° /s , d=-0.88 ) , but these effects were inconsistent across measurement methods . After hamstring strain , acute isometric and passive straight leg raise deficits resolve within 20 - 50 days . Deficits in eccentric and concentric strength and strength ratios persist after return to play , but this effect was inconsistent across measurement methods . INPUT: Objective In this study , the injury incidence and association with type and volume of training in international rowers were described . Design A prospect i ve cohort design was used over a 12-month period . Patients 20 international rowers who were competing as part of the Irish Amateur Rowing Union squad system . Methods The rowers were interviewed monthly , and data were collected regarding their training and competition exposure as well as their injury experience . Results A mean injury rate of 3.67 per 1000 exposure hours was reported with a total of 44 injuries reported in a 12-month period . The mean number of injuries sustained per athlete was 2.2 ( 1.24 ) over the 12-month period . The area where the greatest number of injuries were reported was the lumbar spine ( 31.82 % of total injuries , 95 % CI 20 to 50 ) ( fig 2 ) followed by the knee ( 15.91 % of total injuries , 95 % CI 10 to 30 ) and the cervical spine ( 11.36 % of total injuries , 95 % CI 5 to 24 ) . Half of the injuries ( 22 injuries , 50 % of total reported injuries ) were to the spine ( χ2 = 30.8 , df = 9 , p = 0.0003 ) . Ergometer training load was the most significantly associated with injury risk ( r = 0.68 , p = 0.01 ) . Conclusion International rowers are at higher risk of injury than most non-contact sports and some contact sports . The high risk of lumbar spine injury and the significant association of high volume of ergometer training merit further research to reduce time and competition lost to injury OBJECTIVES This study aim ed to identify modifiable mechanisms associated with low back injury in adolescent cricket fast bowlers . DESIGN A prospect i ve study design examined the association between intrinsic risk factors , workload , bowling kinematics , lumbar load and low back injury incidence . METHODS Twenty-five injury free fast bowlers , aged 14 - 19 years , were assessed prior to the start of a cricket season and observed during the season for low back injuries . RESULTS The twelve bowlers who suffered a low back injury displayed ; decreased hip flexion at front foot contact ( 46±6 ° vs 51±6 ° ) , increased pelvis rotation ( 287±11 ° vs 277±11 ° ) increased thorax lateral flexion ( 50±6 ° vs 40±8 ° ) at ball release , and larger peak lumbar flexion ( 10.5±4.9Nmkg(-1)m(-1 ) vs 6.9±2.5Nmkg(-1)m(-1 ) ) and lateral flexion moments ( 12.5±2.6Nmkg(-1)m(-1 ) vs 10.6±1.9Nmkg(-1)m(-1 ) ) . They also exhibited reduced muscular endurance of the back extensors ( 103±33s vs 132±33s ) and increased knee valgus angle during a single leg decline squat on the dominant ( 9±3 ° vs 5±4 ° ) and non-dominant leg ( 9±4 ° vs 6±3 ° ) in comparison to uninjured bowlers . CONCLUSIONS Bowlers who experience greater lumbar loads during bowling , have reduced back extensor muscle endurance , and demonstrate impaired control of the lumbo-pelvic-hip complex , are at increased risk of low back injury . This combination of strength , control and biomechanical factors may be key mechanical elements of low back injury causation in adolescent fast bowlers OBJECTIVES This study compared sports injury incidence in young high-level athletes from various team and individual sports and investigated if sport participation patterns are linked to injuries . DESIGN Prospect i ve cohort follow-up . METHODS Pupils from a public sports school ( 12 - 19 years ) were recruited over two separate school years ( 2008 - 2009 : 42 weeks , n=199 athletes ; 2009 - 2010 : 40 weeks , n=89 athletes ) . Training and competition volume and intensity were recorded via a personal sports diary . Sports injuries ( time-loss definition ) were registered by medical staff members using a st and ardized question naire . RESULTS Injury incidence was significantly higher in team compared with individual sports ( 6.16 versus 2.88 injuries/1000h , respectively ) , as a result of a higher incidence of both traumatic ( RR=2.17 ; CI95%=1.75 - 2.70 ; p<0.001 ) , and overuse injuries ( RR=2.06 ; CI95%=1.46 - 2.91 ; p<0.001 ) . A Cox proportional hazards regression revealed that team sports participation had a hazard ratio of 2.00 ( CI95%=1.49 - 2.68 ; p<0.001 ) compared to individual sports , with additionally previous injury being a risk and age a protective factor . The number of competitions per 100 days was significantly higher in team sports , whereas the number of intense training sessions per 100 days was significantly lower . In team sports , the number of competitions per 100 days was positively associated with injuries ( HR=1.072 ; CI95 % [ 1.033 ; 1.113 ] ; p<0.001 ) , while in individual sports the number of competitions per 100 days had a protective effect ( HR=0.940 ; CI95 % [ 0.893 ; 0.989 ] ; p=0.017 ) . CONCLUSIONS Team sports participation entailed a higher injury risk , whatever the injury category . Further research should eluci date the role of characteristics related to sport participation in injury causation AIM The aim of this study was to examine injury incidence in professional football players according to the playing positions and with a OUTPUT:

Conclusions Our results demonstrate that the existence of a relationship between training load and injury continues to be well supported in the literature and is strongest for subjective internal training load . The directionality of this relationship appears to depend on the type and timeframe of load measured

MS2_dynamic_1_shot41

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: There have been cl aims that the postoperative course of patients may be improved by presentation during general anesthesia of therapeutic suggestions which predict a rapid and comfortable postoperative recovery . This study evaluated the effectiveness of such therapeutic suggestions under double-blind and r and omized conditions . A tape recording predicting a smooth recovery during a short postoperative stay without pain , nausea , or vomiting was played during anesthesia to about half the patients ( N = 109 ) , while the remaining , control patients were played a blank tape instead ( N = 100 ) . The patients were primarily undergoing operations on the fallopian tubes , total abdominal hysterectomy , vertical b and ing gastroplasty , cholecystectomy , and ovarian cystectomy or myomectomy . The anesthesia methods consisted of either isoflurane with 70 % nitrous oxide in oxygen to produce end-tidal concentrations of 1.0 , 1.3 , or 1.5 MAC ; or 70 % nitrous oxide in oxygen combined with high or low doses of opioids . Assessment s of the efficacy of the therapeutic suggestions in the recovery room and throughout the postoperative hospital stay included : the frequency of administration of analgesic and antiemetic drugs ; opioid doses ; the incidence of fever ; nausea , retching , and vomiting ; other gastrointestinal and urinary symptoms ; ratings of pain ; ratings of anxiety ; global ratings of the patients ' physical and psychological recoveries by the patients and their nurses ; and length of postoperative hospital stay . There were no meaningful , significant differences in postoperative recovery of patients receiving therapeutic suggestions and controls . These negative results were not likely to be due to insensitivity of the assessment s of recovery , as they showed meaningful interrelations among themselves and numerous differences in recovery following different types of surgery . Widespread utilization of therapeutic suggestions as a routine operating room procedure seems premature in the absence of adequate replication of previously published positive studies Immediately before they underwent femoral angiography , 45 patients were given one of three types of audiotapes : a relaxation response tape recorded for this study , a tape of contemporary instrumental music , or a blank tape . All patients were instructed to listen to their audiotape during the entire angiographic procedure . Each audiotape was played through earphones . Radiologists were not told the group assignment or tape contents . The patients given the audiotape with instructions to elicit the relaxation response ( n = 15 ) experienced significantly less anxiety ( P less than .05 ) and pain ( P less than .001 ) during the procedure , were observed by radiology nurses to exhibit significantly less pain ( P less than .001 ) and anxiety ( P less than .001 ) , and requested significantly less fentanyl citrate ( P less than .01 ) and diazepam ( P less than .01 ) than patients given either the music ( n = 14 ) or the blank ( n = 16 ) control audiotapes . Elicitation of the relaxation response is a simple , inexpensive , efficacious , and practical method to reduce pain , anxiety , and medication during femoral angiography and may be useful in other invasive procedures CONTEXT Previous studies on the effect of mindfulness-based stress reduction ( MBSR ) therapy on chronic pain syndromes have been hampered by study design . OBJECTIVE To evaluate short-term efficacy of MBSR therapy for improving quality of life in adults with failed back surgery syndrome ( FBSS ) . DESIGN A single-center , prospect i ve , r and omized , single-blind , parallel-group clinical trial . PATIENTS AND SETTING Participants were recruited from a multidisciplinary spine and rehabilitation center in the greater Portl and , Maine , area . INTERVENTIONS AND MAIN OUTCOME MEASURES Patients were r and omly assigned at baseline to receive either MBSR therapy plus traditional therapy or traditional therapy alone for an 8-week period . Those receiving MBSR therapy completed weekly group sessions , and the control group continued with their traditional care as prescribed by their medical care providers . At study enrollment and at 12-week follow-up , all participants completed question naires on pain , quality of life , functionality , analgesic use , and sleep quality . Patients in the intervention group also completed question naires at 40-week follow-up . RESULTS The final analysis included 25 patients with FBSS ; 15 patients were in the MBSR intervention arm , and 10 in the control group . At 12-week follow-up , patients in the intervention arm had a mean 7.0-point increase ( on an 108-point [ corrected ] scale ) in pain acceptance and quality of life on the Chronic Pain Assessment Question naire , a mean 3.6-point [ corrected ] decrease ( on a 24-point scale ) in functional limitation on the Rol and -Morris Disability Question naire , a mean 6.9-point [ corrected ] reduction ( on a 30-point scale ) in pain level on the Summary Visual Analog Scale for Pain , a mean 1.5-point [ corrected ] reduction ( on a 4-point scale ) in frequency of use and potency of analgesics used for pain and recorded on logs , and a mean 2.0-point [ corrected ] increase ( on a 5-point scale ) in sleep quality on the abridged Pittsburgh Sleep Quality Inventory . These results were statistically and clinical ly significant compared to outcomes for the control group . CONCLUSION The results suggest that MBSR can be a useful clinical intervention for patients with FBSS A prospect i ve study was design ed to compare two psychological support interventions in controlling peri-dressing change pain and anxiety in severely burned patients . Thirty patients with a total burned surface area of 10 - 25 % , requiring a hospital stay of at least 14 days , were r and omised to receive either hypnosis or stress reducing strategies ( SRS ) adjunctively to routine intramuscular pre-dressing OUTPUT: Conclusions and Relevance The findings suggest that MBTs are associated with moderate improvements in pain and small reductions in opioid dose and may be associated with therapeutic benefits for opioid-related problems , such as opioid craving and misuse . INPUT: Abstract Although medical hypnosis has a long history of myriad functional applications ( pain reduction , procedural preparation etc . ) , it has been little tested for site-specific effects on physical healing per se . In this r and omized controlled trial , we compared the relative efficacy of an adjunctive hypnotic intervention , supportive attention , and usual care only on early post-surgical wound healing . Eighteen healthy women presenting consecutively for medically recommended reduction mammaplasty at an ambulatory surgery practice underwent the same surgical protocol and postoperative care following preoperative r and omization ( n = 6 each ) to one of the three treatment conditions : usual care , 8 adjunctive supportive attention sessions , or 8 adjunctive hypnosis sessions targeting accelerated wound healing . The primary outcome data of interest were objective , observational measures of incision healing made at 1,7 weeks postoperatively by medical staff blind to the participants ' group assignments . Data included clinical exams and digitized photographs that were scored using a wound assessment inventory ( WAI ) . Secondary outcome measures included the participants ' subjectively rated pain , perceived incision healing ( VAS Scales ) , and baseline and post-surgical functional health status ( SF-36 ) . Analysis of variance showed the hypnosis group 's objective ly observed wound healing to be significantly greater than the other two groups ' , p < .001 , through 7 postoperative weeks ; st and ard care controls showed the smallest degree of healing . In addition , at both the 1 and 7 week post-surgical observation intervals , one-way analyses showed the hypnosis group to be significantly more healed than the usual care controls , p < 0 . 02 . The mean scores of the subjective assessment s of postoperative pain , incision healing and functional recovery trended similarly . Results of this preliminary trial indicate that use of a targeted hypnotic intervention can accelerate postoperative wound healing and suggest that further tests of using hypnosis to augment physical healing are warranted This study aim ed at testing human skin wound healing improvement by a 21-day supplementation of 1.0 g ascorbic acid ( AA ) and 0.2 g pantothenic acid ( PA ) . 49 patients undergoing surgery for tattoos , by the successive resections procedure , entered a double-blind , prospect i ve and r and omized study . Tests performed on both skin and scars determined : hydroxyproline concentrations , number of fibroblasts , trace element contents and mechanical properties . In the 18 supplemented patients , it was shown that in skin ( day 8) Fe increased ( p < 0.05 ) and Mn decreased ( p < 0.05 ) ; in scars ( day 21 ) , Cu ( p = 0.07 ) and Mn ( p < 0.01 ) decreased , and Mg ( p < 0.05 ) increased ; the mechanical properties of scars in group A were significantly correlated to their contents in Fe , Cu and Zn , whereas no correlation was shown in group B. In blood , AA increased after surgery with supplementation , whereas it decreased in controls . Although no major improvement of the would healing process could be documented in this study , our results suggest that the benefit of AA and PA supplementation could be due to the variations of the trace elements , as they are correlated to mechanical properties of the scars OBJECTIVES Psychological stress is believed to impair wound healing via a down-regulation of the immune system . Since previous research suggests that disclosure of tra-umatic experiences can result in an up-regulation of immune function , the present study aim ed to investigate the impact of a disclosure intervention on the progress of wound healing . DESIGN The study used a prospect i ve , longitudinal design with r and om assignment to the control ( writing about time management ) and experimental group ( writing about a traumatic event ) . METHODS Participants ( N=36 ) completed question naires measuring perceived and emotional distress , loneliness , self-esteem , social support , dispositional optimism , and health-related behaviours . Accurate indication of the healing of a small punch biopsy wound was determined by using a high-resolution ultrasound scanner . RESULTS Repeated measures ANOVA indicated that the disclosure intervention impacted wound healing . Participants who wrote about traumatic events had significantly smaller wounds 14 and 21 days after the biopsy compared with those who wrote about time management . CONCLUSIONS It is concluded that a relatively brief and easy to administer intervention can have beneficial effects on wound healing . The potential for use in patient sample s is indicated Objective : To examine the effect of a brief laboratory stressor and social support before the stressor on cardiovascular and cortisol responses , and skin barrier recovery after skin disruption . Methods : Eighty-five healthy participants ( mean age 22.9 ± 4.4 years ) underwent a “ tape-stripping ” procedure that disrupts normal skin barrier function , and were r and omly assigned to a No Stress ( reading task ) , Stress ( Trier Social Stress Test ) , or Stress + Social Support condition ( support from a confederate before the stressor ) . Skin barrier recovery was assessed by measuring transepidermal water loss from up to 2 hours after skin disruption . Results : Compared with the No Stress condition , the stressor delayed skin barrier recovery by 10 % at 2 hours after skin disruption ( effect size , r = .29 ) , and increased anxiety ( r = .24 ) , negative affect ( r = .22 ) , cardiovascular activity ( r values from .4–.6 ) , and among male participants , cortisol levels ( r = .40 ) . Social support did not influence psychological or physiological responses or skin barrier recovery . Larger physiological responses to the tasks did not predict slower skin barrier recovery . Instead , larger systolic blood pressure responses predicted faster skin barrier recovery ( r = .26 ) . Conclusions : This study replicated the effects of short-term laboratory stressors on skin barrier recovery , further establishing the relevance of skin barrier recovery for future research OUTPUT:

Conclusions This systemic review shows that preoperative interventions can be beneficial in improving wound healing and scar formation . In selected cases , wound healing was found to benefit from a higher preoperative body temperature , topical vitamin E application , and low patient stress levels .

MS2_dynamic_1_shot42

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: AIMS Dapagliflozin , a highly selective inhibitor of sodium-glucose cotransporter 2 ( SGLT2 ) , reduces hyperglycaemia and weight in patients with type 2 diabetes mellitus ( T2DM ) by increasing urinary glucose excretion . Long-term glycaemic control , body composition and bone safety were evaluated in patients with T2DM after 102 weeks of dapagliflozin treatment . METHODS This r and omized , double-blind , placebo-controlled study ( NCT00855166 ) enrolled patients with T2DM [ mean : age 60.7 years ; HbA1c 7.2 % ; body mass index ( BMI ) 31.9 kg/m(2 ) ; body weight 91.5 kg ] inadequately controlled on metformin . Patients ( N = 182 ) were r and omly assigned 1 : 1 to receive dapagliflozin 10 mg/day or placebo added to open-label metformin for a 24-week double-blind treatment period followed by a 78-week site- and patient-blinded extension period . At week 102 , changes from baseline in HbA1c , weight , waist circumference , total body fat mass as measured by dual-energy X-ray absorptiometry ( DXA ) , serum markers of bone turnover , bone mineral density ( BMD ) as measured by DXA , and adverse events were evaluated . RESULTS A total of 140 patients ( 76.9 % ) completed the study . Over 102 weeks , dapagliflozin-treated patients showed reductions in HbA1c by -0.3 % , weight by -4.54 kg , waist circumference by -5.0 cm and fat mass by -2.80 kg without increase in rate of hypoglycaemia . Compared with placebo , no meaningful changes from baseline in markers of bone turnover or BMD were identified over 102 weeks . One fracture occurred in each treatment group . The frequency of urinary tract infection ( UTI ) and genital infection was similar in both treatment groups . CONCLUSIONS Over 102 weeks , dapagliflozin improved glycaemic control , and reduced weight and fat mass , without affecting markers of bone turnover or BMD in patients with T2DM inadequately controlled on metformin OBJECTIVE To determine whether dapagliflozin , which selectively inhibits renal glucose reabsorption , lowers hyperglycemia in patients with type 2 diabetes that is poorly controlled with high insulin doses plus oral antidiabetic agents ( OADs ) . RESEARCH DESIGN AND METHODS This was a r and omized , double-blind , three-arm parallel-group , placebo-controlled , 26-center trial ( U.S. and Canada ) . Based on data from an insulin dose-adjustment setting cohort ( n = 4 ) , patients in the treatment cohort ( n = 71 ) were r and omly assigned 1:1:1 to placebo , 10 mg dapagliflozin , or 20 mg dapagliflozin , plus OAD(s ) and 50 % of their daily insulin dose . The primary outcome was change from baseline in A1C at week 12 ( dapagliflozin vs. placebo , last observation carried forward [ LOCF ] ) . RESULTS At week 12 ( LOCF ) , the 10- and 20-mg dapagliflozin groups demonstrated −0.70 and −0.78 % mean differences in A1C change from baseline versus placebo . In both dapagliflozin groups , 65.2 % of patients achieved a decrease from baseline in A1C ≥0.5 % versus 15.8 % in the placebo group . Mean changes from baseline in fasting plasma glucose ( FPG ) were + 17.8 , + 2.4 , and −9.6 mg/dl ( placebo , 10 mg dapagliflozin , and 20 mg dapagliflozin , respectively ) . Postpr and ial glucose ( PPG ) reductions with dapagliflozin also showed dose dependence . Mean changes in total body weight were −1.9 , −4.5 , and −4.3 kg ( placebo , 10 mg dapagliflozin , and 20 mg dapagliflozin ) . Overall , adverse events were balanced across all groups , although more genital infections occurred in the 20-mg dapagliflozin group than in the placebo group . CONCLUSIONS In patients receiving high insulin doses plus insulin sensitizers who had their baseline insulin reduced by 50 % , dapagliflozin decreased A1C , produced better FPG and PPG levels , and lowered weight more than placebo Sodium – glucose cotransporter 2 ( SGLT2 ) inhibitors are a newly approved class of glucose-lowering medications with a novel mechanism of action . These agents increase glycosuria , which leads to improved glucose control . They also produce an osmotic diuresis that , in part , contributes to blood pressure reduction and calorie loss secondary to glycosuria leading to weight loss ( 1,2 ) . A recent review of SGLT2 inhibitors focuses on the blood pressure – lowering effects of the two approved glucose-lowering agents , dapagliflozin and canagliflozin ( 3 ) . While not approved as antihypertensive agents , they may potentially aid in lowering blood pressure in patients with diabetes . A review of studies in both hypertensive and normotensive patients with type 2 diabetes demonstrates a 4–10 mmHg reduction of systolic blood pressure ( 3 ) . In this issue of Diabetes Care , Tikkanen et al. ( 4 ) investigate the effectiveness and safety OUTPUT: The drug class effect of SUA reduction suggesting SGLT2 inhibitors might be beneficial for diabetic patients with hyperuricemia INPUT: BACKGROUND Excessive energy intake tends to increase circulating levels of insulin and free insulin-like growth factor-1 ( IGF-I ) , which may increase risk of some cancers that are common in Western countries . However , the relative importance of these hormonal factors during pre-adulthood and adulthood is unknown . METHODS We prospect ively examined height , as a marker of pre-adult IGF-I bioactivity , and modifiable adult determinants of insulin secretion , in relation to risk of cancer , particularly Western-related cancers ( colon , pancreas , kidney , and aggressive prostate cancers ) in 47,690 male health professionals . Information about dietary and lifestyle factors for these men was collected at baseline ( 1986 ) and was up date d periodically . A C-peptide score , representing insulin secretion , was created by using body mass , physical activity , and diet in a stepwise linear regression to predict C-peptide level , in a sample of 263 cohort members . RESULTS From 1986 to 1998 , we documented 3270 incident cancers ( excluding the less aggressive prostate cancers ) . Greater body mass index , lower physical activity , and a Western dietary pattern were independent predictors of higher plasma C-peptide levels in the sample . A C-peptide score , based on these variables , was positively related to risk of Western-related cancers , but not to other cancer types in the entire cohort . Height was also only related to Western-related cancers . For Western-related cancers , 29 % ( 95 % CI : 16 % , 48 % ) were attributed to C-peptide scores above the first decile , 30 % ( 95 % CI : 11 % , 58 % ) to heights > or=66 inches , and 49 % ( 95 % CI : 30 % , 69 % ) to both factors combined . For total cancers , 29 % ( 95 % CI : 16 % , 46 % ) were attributable to both factors . CONCLUSIONS Maximal growth in the pre-adult period and hyperinsulinaemia during adulthood may largely underlie the excess risk of some cancers that are common in Western population s. A substantial proportion of these cancers may be modifiable in adulthood , through alterations in body weight , sedentary behaviour , and dietary patterns that stimulate hyperinsulinaemia The effect of dietary fructose ( 20 % of carbohydrate calories , 45 - 65 g day-1 for 4 weeks ) on glycaemic control , serum lipid , lipoprotein and apoprotein A-I and A-II concentrations and on insulin sensitivity was studied in 10 type 2 diabetic patients . The study was done in a r and omized , double-blind fashion with crystalline fructose or placebo administered evenly during 4 meals or snacks per day . The patients were hospitalized throughout the study periods . The fasting plasma glucose concentration decreased during the fructose ( from 10.7 + /- 1.4 mmol l-1 to 8.0 + /- 0.8 mmol l-1 , P < 0.02 ) and the control diet ( from 10.1 + /- 0.9 mmol l-1 to 8.0 + /- 0.7 mmol l-1 , P < 0.05 ) . The mean diurnal blood glucose concentration also fell both during the fructose ( from 10.8 + /- 0.5 mmol l-1 to 8.4 + /- 0.3 mmol l-1 , P < 0.001 ) and the control diet ( from 10.3 + /- 0.3 mmol l-1 to 8.8 + /- 0.9 mmol l-1 , P < 0.01 ) . The HbA1 concentration improved ( P < 0.02 ) only during the fructose diet . Insulin sensitivity increased by 34 % ( P < 0.05 ) during the fructose diet , but remained unchanged during the control period . Serum insulin , triglyceride , apoprotein A-I and A-II concentrations , body weight , blood pressure and blood lactate remained unchanged during both diets . In conclusion , substitution of moderate amounts of fructose for complex carbohydrates can improve glycaemic control and insulin sensitivity in patients with type 2 diabetes OUTPUT:

Fructose consumption did not significantly affect fasting glucose or insulin . A priori subgroup analyses showed no evidence of effect modification on any end point . Isocaloric exchange of fructose for other carbohydrate improves long-term glycemic control , as assessed by glycated blood proteins , without affecting insulin in people with diabetes .

MS2_dynamic_1_shot43

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people . Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures , as proved by Decalyos I. Decalyos II is a 2-year , multicenter , r and omized , double-masked , placebo-controlled confirmatory study . The intention-to-treat population consisted of 583 ambulatory institutionalized women ( mean age 85.2 years , SD = 7.1 ) r and omized to the calcium – vitamin D3 fixed combination group ( n= 199 ) ; the calcium plus vitamin D3 separate combination group ( n= 190 ) and the placebo group ( n= 194 ) . Fixed and separate combination groups received the same daily amount of calcium ( 1200 mg ) and vitamin D3 ( 800 IU ) , which had similar pharmacodynamic effects . Both types of calcium-vitamin D3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent , with levels returning within the normal range after 6 months . In a subgroup of 114 patients , femoral neck bone mineral density ( BMD ) decreased in the placebo group ( mean = –2.36 % per year , SD = 4.92 ) , while remaining unchanged in women treated with calcium-vitamin D3 ( mean = 0.29 % per year , SD = 8.63 ) . The difference between the two groups was 2.65 % ( 95 % CI = –0.44 , 5.75 % ) with a trend in favor of the active treatment group . No significant difference between groups was found for changes in distal radius BMD and quantitative ultrasonic parameters at the os calcis . The relative risk ( RR ) of HF in the placebo group compared with the active treatment group was 1.69 ( 95 % CI = 0.96 , 3.0 ) , which is similar to that found in Decalyos I ( RR = 1.7 ; 95 % CI = 1.0 , 2.8 ) . Thus , these data are in agreement with those of Decalyos I and indicate that calcium and vitamin D3 in combination reverse senile secondary hyperparathyroidism and reduce both hip bone loss and the risk of hip fracture in elderly institutionalized women The aim of this population -based matched case-control study was to evaluate the effect of risk factors for hip fracture in Oslo , Norway , which has some of the highest incidence rates ever reported . The study population comprised all non-institutionalized persons 50 years or older living in the catchment area of two Oslo hospitals , and cases were 246 patients admitted for hip fracture during a 1-year period . The controls were r and omly selected from the study population , matched 1:1 for age and sex . Hip fracture was associated with lean body stature , smoking , low grip strength and decreased levels of physical activity , and inversely with length of education . In addition , hip fracture was inversely related to indicators of total food intake ( number of meals per day , frequency of dinners , and slices of bread per day ) . A relation between hip fracture and low vitamin D intake was also suggested , whereas no association with dietary calcium intake was found . Finally , increased risk of fracture was seen in persons reporting two or more hospital admissions in the previous 2 years , and in those reporting weight reduction due to poor appetite during the previous year . In conclusion , the risk factor pattern for hip fracture was much the same in the elderly population of Oslo as previously described in other population s with a lower incidence of fracture . This study also indicates a relation between hip fracture and low food intake Abstract : Low bone mineral density ( BMD ) is one of the most important elements for the diagnosis of osteoporosis and screening people with higher risk of fractures . To establish the criterion value of BMD for the diagnosis of osteoporosis and to estimate the prevalence rate of osteoporosis in Japanese women , we performed a Japanese population -based osteoporosis ( JPOS ) study . The subjects were 4550 women aged 15 through 79 years r and omly selected from seven municipalities throughout Japan . The sample size was determined to ensure that the observed mean BMD would remain within 2.5 % from the real value with a probability of 0.95 in each of the 5-year age groups . The study comprised bone mass measurements by dual-energy X-ray absorptiometry at the spine ( L2–4 ) , hip and distal forearm , body size measurements and detailed interviews on medical and gynecologic history . After excluding those subjects with apparent or suggested abnormalities affecting bone mass from 3985 women ( 87.6 % ) who completed the study , 3465 women remained and served as the subjects . We present 5-year age-specific mean values of BMD and cut-off values for the diagnosis of osteoporosis according to World Health Organization ( WHO ) and the Japanese Society of Bone and Mineral Research ( JSBMR ) criteria . The cut-off levels at the spine and the distal radius proposed in this study were similar to those proposed by the JSBMR but the cut-off level at the femoral neck in this study was 4.7 % higher than that of the JSBMR . The prevalence rates of osteoporosis according to WHO criteria in the present subjects aged 50 through 79 years were calculated as 38.0 % at the spine , 11.6 % at the femoral neck and 56.8 % at the distal one-third site of the radius , and those in the Japanese female population of the same age were estimated to be 35.1 % , 9.4 % and 51.2 % , respectively . A fivefold difference was observed among the prevalence rates at different skeletal sites , which suggests that the different definitions of osteoporosis should be established for the different skeletal sites . The prevalence OUTPUT: The result of the present systematic review gives the evidence showing that calcium supplementation or optimal dietary calcium intake increases bone density in childhood and adolescence and reduces the risk of fracture due to osteoporosis in the elderly people regardless of the gender . INPUT: Dietary data from a prospect i ve study were used to relate factors influencing calcium balance ( estimates of dietary calcium intake , protein intake from nondairy animal sources ( meat , fish , and eggs ) , and coffee consumption ) to the incidence of hip fracture . During the years 1977 - 1983 , women and men born between 1925 and 1940 and living in one of three Norwegian counties were invited to a cardiovascular screening that included a dietary survey . The attendance rate at screening was 91.1 % , and 90.7 % of these persons ( 19,752 women and 20,035 men ) filled in and returned a semiquantitative dietary question naire . This cohort was followed for an average of 11.4 years ( range , 0.01 - 13.8 years ) with respect to hip fracture , defined as cervical or trochanteric fracture . During follow-up , 213 hip fractures were identified , excluding fractures associated with high-energy trauma and metastatic bone disease . There was no clear association between calcium intake or nondairy animal protein intake and hip fracture in this cohort . However , an elevated risk of fracture was found in women with a high intake of protein from nondairy animal sources in the presence of low calcium intake ( relative risk = 1.96 ( 95 % confidence interval 1.09 - 3.56 ) for the highest quarter of nondairy protein intake and the lowest quarter of calcium intake vs. the three lower quarters of protein intake and the three higher quarters of calcium intake ) . Women who drank nine or more cups of coffee per day also had an increased risk of fracture , while there was no association between coffee consumption and hip fracture in men . Although these findings do not necessarily imply causal relations , they suggest the presence of risk factors for hip fracture that act through a negative calcium balance in this population Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people . Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures , as proved by Decalyos I. Decalyos II is a 2-year , multicenter , r and omized , double-masked , placebo-controlled confirmatory study . The intention-to-treat population consisted of 583 ambulatory institutionalized women ( mean age 85.2 years , SD = 7.1 ) r and omized to the calcium – vitamin D3 fixed combination group ( n= 199 ) ; the calcium plus vitamin D3 separate combination group ( n= 190 ) and the placebo group ( n= 194 ) . Fixed and separate combination groups received the same daily amount of calcium ( 1200 mg ) and vitamin D3 ( 800 IU ) , which had similar pharmacodynamic effects . Both types of calcium-vitamin D3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent , with levels returning within the normal range after 6 months . In a subgroup of 114 patients , femoral neck bone mineral density ( BMD ) decreased in the placebo group ( mean = –2.36 % per year , SD = 4.92 ) , while remaining unchanged in women treated with calcium-vitamin D3 ( mean = 0.29 % per year , SD = 8.63 ) . The difference between the two groups was 2.65 % ( 95 % CI = –0.44 , 5.75 % ) with a trend in favor of the active treatment group . No significant difference between groups was found for changes in distal radius BMD and quantitative ultrasonic parameters at the os calcis . The relative risk ( RR ) of HF in the placebo group compared with the active treatment group was 1.69 ( 95 % CI = 0.96 , 3.0 ) , which is similar to that found in Decalyos I ( RR = 1.7 ; 95 % CI = 1.0 , 2.8 ) . Thus , these data are in agreement with those of Decalyos I and indicate that calcium and vitamin D3 in combination reverse senile secondary hyperparathyroidism and reduce both hip bone loss and the risk of hip fracture in elderly institutionalized women Summary The relationship between osteoporosis risk factors , bone quantitative ultrasound ( QUS ) and non-spinal fracture risk was estimated in a cohort of 5,201 postmenopausal women from Spain who were prospect ively evaluated during three years . Several clinical risk factors and low heel QUS values were independently associated with non-spinal fracture risk . Introduction Low-trauma , non-spinal fractures are a growing source of morbidity and mortality in the elderly . The aim of the present study was to examine the association of heel quantitative ultrasound ( QUS ) and a series of osteoporosis and fracture risk factors , with incident low energy non-spinal fractures in a population of elderly women , and to incorporate them into fracture prediction models . Methods 5,201 women aged 65 or older were enrolled in a three-year cohort study . Participants completed an osteoporosis and fracture risk factors question naire . QUS was measured at the heel with a gel-coupled device . Cox-proportional hazard analyses were performed to evaluate the association with the first incident low-trauma non-spinal fracture . Results Three hundred and eleven women ( 6.0 % ) sustained a total of 363 low-trauma fractures , including 133 forearm/wrist , 54 hip , 50 humerus , 37 leg and 17 pelvic fractures . For every st and ard deviation decrease in the quantitative ultrasound index , the adjusted hazard ratios ( 95 % CI ) for any non OUTPUT:

CONCLUSIONS Dietary calcium intake is not associated with risk of fracture , and there is no clinical trial evidence that increasing calcium intake from dietary sources prevents fractures .

MS2_dynamic_1_shot44

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND AND OBJECTIVE : Relative deficiency of dietary omega 3 polyunsaturated fatty acids ( n-3 PUFA ) has been implicated in the rising allergy prevalence in Westernized countries . Fish oil supplementation may provide an intervention strategy for primary allergy prevention . The objective of this study was to assess the effect of fish oil n-3 PUFA supplementation from birth to 6 months of age on infant allergic disease . METHODS : In a double-blind r and omized controlled trial , 420 infants at high atopic risk received a daily supplement of fish oil containing 280 mg docosahexaenoic acid and 110 mg eicosapentaenoic acid or a control ( olive oil ) , from birth to age 6 months . PUFA levels were measured in 6-month-old infants ’ erythrocytes and plasma and their mothers ’ breast milk . Eczema , food allergy , asthma and sensitization were assessed in 323 infants for whom clinical follow-up was completed at 12 months of age . RESULTS : At 6 months of age , infant docosahexaenoic acid and eicosapentaenoic acid levels were significantly higher ( both P < .05 ) and erythrocyte arachidonic acid levels were lower ( P = .003 ) in the fish oil group . Although n-3 PUFA levels at 6 months were associated with lower risk of eczema ( P = .033 ) and recurrent wheeze ( P = .027 ) , the association with eczema was not significant after multiple comparisons and there was no effect of the intervention per se on the primary study outcomes . Specifically , between-group comparisons revealed no differences in the occurrence of allergic outcomes including sensitization , eczema , asthma , or food allergy . CONCLUSIONS : Postnatal fish oil supplementation improved infant n-3 status but did not prevent childhood allergic disease We have previously reported a protective effect of maternal omega-3 long-chain polyunsaturated fatty acids ( ω-3 LCPUFA ) supplementation in pregnancy and lactation on IgE-associated eczema and food allergy in the infant during the first year of life . Here we investigate whether the effects of the LCPUFA supplementation on IgE-associated diseases last up to 2 yr of age and assess the relationship between plasma proportions of ω-3 PUFAs and the frequency and severity of infant allergic disease . 145 pregnant women , at risk of having an allergic infant , were r and omized to daily supplementation with 1.6 g eicosapentaenoic acid ( EPA ) and 1.1 g docosahexaenoic acid ( DHA ) or placebo starting in the 25th gestational week and continuing through 3.5 months of breastfeeding . Clinical examinations , skin prick tests and analysis of maternal and infant plasma phospholipid fatty acids and infant specific IgE were performed . No difference in the prevalence of allergic symptoms was found between the intervention groups . The cumulative incidence of IgE-associated disease was lower in the ω-3-supplemented group ( 6/54 , 13 % ) compared with the placebo group ( 19/62 , 30 % , p=0.01 ) . Higher maternal and infant proportions of DHA and EPA were associated with lower prevalence of IgE associated disease ( p=0.01 - 0.05 ) in a dose-dependent manner . Higher maternal and infant proportions of DHA and EPA were found if the infants presented none , when compared with multiple allergic symptoms , ( p<0.05 ) regardless of sensitization . In summary , the ω-3 supplementation offered no obvious preventive effect on the prevalence of clinical symptoms of allergic disease , but the decrease in cumulative incidence of IgE-associated disease seen during the first year still remained until 2 yr of age . Furthermore , high proportions of DHA and EPA in maternal and infant plasma phospholipids were associated with less IgE-associated disease and a reduced severity of the allergic phenotype Perinatal administration of the probiotic Lactobacillus rhamnosus strain GG ( ATCC 53103 ) , reduces incidence of atopic eczema in at-risk children during the first 2 years of life ( infancy ) . We have therefore assessed persistence of the potential to prevent atopic eczema at 4 years . Atopic disease was diagnosed on the basis of a question naire and a clinical examination . 14 of 53 children receiving lactobacillus had developed atopic eczema , compared with 25 of 54 receiving placebo ( relative risk 0.57 , 95 % CI 0.33 - 0.97 ) . Skin prick test reactivity was the same in both groups : ten of 50 children previously given lactobacillus compared with nine of 50 given placebo tested positive . Our results suggest that the preventive effect of lactobacillus GG on atopic eczema extends beyond infancy Abstract n−3 PUFA influence immune functioning and may affect the cytokine phenotype during development . To examine whether maternal fish oil supplementation during lactation could modify later immune responses in children , 122 lactating Danish mothers with a fish intake below the population median were r and omized to groups supplemented for the first 4 mon of lactation with 4.5 g/d of fish oil ( equivalent to 1.5 g/d of n−3 long-chain PUFA ) or olive oil . Fifty-three mothers with a fish intake in the highest quartile of the population were also included . The FA composition of erythrocyte membranes was measured at 4 mon and at 2 1/2 yr . Plasma immunoglobulin E ( IgE ) levels and cytokine production in lipopolysaccharide-stimulated whole-blood cultures were determined at OUTPUT: However , there are still many gaps in the evidence of dietary primary prevention of allergic diseases INPUT: BACKGROUND AND OBJECTIVE : Relative deficiency of dietary omega 3 polyunsaturated fatty acids ( n-3 PUFA ) has been implicated in the rising allergy prevalence in Westernized countries . Fish oil supplementation may provide an intervention strategy for primary allergy prevention . The objective of this study was to assess the effect of fish oil n-3 PUFA supplementation from birth to 6 months of age on infant allergic disease . METHODS : In a double-blind r and omized controlled trial , 420 infants at high atopic risk received a daily supplement of fish oil containing 280 mg docosahexaenoic acid and 110 mg eicosapentaenoic acid or a control ( olive oil ) , from birth to age 6 months . PUFA levels were measured in 6-month-old infants ’ erythrocytes and plasma and their mothers ’ breast milk . Eczema , food allergy , asthma and sensitization were assessed in 323 infants for whom clinical follow-up was completed at 12 months of age . RESULTS : At 6 months of age , infant docosahexaenoic acid and eicosapentaenoic acid levels were significantly higher ( both P < .05 ) and erythrocyte arachidonic acid levels were lower ( P = .003 ) in the fish oil group . Although n-3 PUFA levels at 6 months were associated with lower risk of eczema ( P = .033 ) and recurrent wheeze ( P = .027 ) , the association with eczema was not significant after multiple comparisons and there was no effect of the intervention per se on the primary study outcomes . Specifically , between-group comparisons revealed no differences in the occurrence of allergic outcomes including sensitization , eczema , asthma , or food allergy . CONCLUSIONS : Postnatal fish oil supplementation improved infant n-3 status but did not prevent childhood allergic disease Background Observational studies suggest high prenatal vitamin D intake may be associated with reduced childhood wheezing . We examined the effect of prenatal vitamin D on childhood wheezing in an interventional study . Methods We r and omised 180 pregnant women at 27 weeks gestation to either no vitamin D , 800 IU ergocalciferol daily until delivery or single oral bolus of 200,000 IU cholecalciferol , in an ethnically stratified , r and omised controlled trial . Supplementation improved but did not optimise vitamin D status . Research ers blind to allocation assessed offspring at 3 years . Primary outcome was any history of wheeze assessed by vali date d question naire . Secondary outcomes included atopy , respiratory infection , impulse oscillometry and exhaled nitric oxide . Primary analyses used logistic and linear regression . Results We evaluated 158 of 180 ( 88 % ) offspring at age 3 years for the primary outcome . Atopy was assessed by skin test for 95 children ( 53 % ) , serum IgE for 86 ( 48 % ) , exhaled nitric oxide for 62 ( 34 % ) and impulse oscillometry of acceptable quality for 51 ( 28 % ) . We found no difference between supplemented and control groups in risk of wheeze [ no vitamin D : 14/50 ( 28 % ) ; any vitamin D : 26/108 ( 24 % ) ( risk ratio 0.86 ; 95 % confidence interval 0.49 , 1.50 ; P = 0.69 ) ] . There was no significant difference in atopy , eczema risk , lung function or exhaled nitric oxide between supplemented groups and controls . Conclusion Prenatal vitamin D supplementation in late pregnancy that had a modest effect on cord blood vitamin D level , was not associated with decreased wheezing in offspring at age three years . Trial Registration Controlled-Trials.com IS RCT BACKGROUND Some breastfed infants with atopic eczema benefit from elimination of cow milk , egg , or other antigens from their mother 's diet . Maternal dietary antigens are also known to cross the placenta . OBJECTIVES To assess the effects of prescribing an antigen avoidance diet during pregnancy or lactation , or both , on maternal and infant nutrition and on the prevention or treatment of atopic disease in the child . SEARCH METHODS We search ed the Cochrane Pregnancy and Childbirth Group 's Trials Register ( 6 July 2012 ) . SELECTION CRITERIA All r and omized or quasi-r and omized comparisons of maternal dietary antigen avoidance prescribed to pregnant or lactating women . We excluded trials of multimodal interventions that included manipulation of the infant 's diet other than breast milk or of non-dietary aspects of the infant 's environment . DATA COLLECTION AND ANALYSIS We extracted data from published reports , supplemented by additional information received from the trialists we contacted . MAIN RESULTS The evidence from five trials , involving 952 participants , does not suggest a protective effect of maternal dietary antigen avoidance during pregnancy on the incidence of atopic eczema during the first 18 months of life . Data on allergic rhinitis or conjunctivitis , or both , and urticaria are limited to a single trial each and are insufficient to draw meaningful inferences . Longer-term atopic outcomes have not been reported . The restricted diet during pregnancy was associated with a slightly but statistically significantly lower mean gestational weight gain , a non-significantly higher risk of preterm birth , and a non-significant reduction in mean birthweight . The evidence from two trials , involving 523 participants , did not observe a significant protective effect of maternal antigen avoidance during lactation on the incidence of atopic eczema during the first 18 months or on positive skin-prick tests to cow milk , egg , or pe OUTPUT:

Based on the existing information , it is not possible to establish the role of antioxidants and vitamin D supplementation in atopic disease development . There is no evidence of major effects of prenatal use of folic acid on asthma or allergies . The association of some nutritional interventions with less atopic sensitization seems rather speculative even if such an effect has not been found for some other foods . The findings indicate rather a balanced and diverse diet without restrictions than a special dietary protocol . Farming-related exposures may protect against the development of atopic disorders in children . Long-chain polyunsaturated fatty acids and probiotics seem to be promising c and i date s for allergy prevention .

MS2_dynamic_1_shot45

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Pulmonary rehabilitation ( PR ) is an effective intervention for the management of people with chronic obstructive pulmonary disease ( COPD ) . However , available re sources are often limited , and many patients bear with poor availability of programmes . Sustaining PR benefits and regular exercise over the long term is difficult without any exercise maintenance strategy . In contrast to traditional centre-based PR programmes , telerehabilitation may promote more effective integration of exercise routines into daily life over the longer term and broaden its applicability and availability . A few studies showed promising results for telerehabilitation , but mostly with short-term interventions . The aim of this study is to compare long-term telerehabilitation with unsupervised exercise training at home and with st and ard care . Methods / Design An international multicentre r and omised controlled trial conducted across sites in three countries will recruit 120 patients with COPD . Participants will be r and omly assigned to telerehabilitation , treadmill and control , and followed up for 2 years . The telerehabilitation intervention consists of individualised exercise training at home on a treadmill , telemonitoring by a physiotherapist via videoconferencing using a tablet computer , and self-management via a customised website . Patients in the treadmill arm are provided with a treadmill only to perform unsupervised exercise training at home . Patients in the control arm are offered st and ard care . The primary outcome is the combined number of hospitalisations and emergency department presentations . Secondary outcomes include changes in health status , quality of life , anxiety and depression , self-efficacy , subjective impression of change , physical performance , level of physical activity , and personal experiences in telerehabilitation . Discussion This trial will provide evidence on whether long-term telerehabilitation represents a cost-effective strategy for the follow-up of patients with COPD . The delivery of telerehabilitation services will also broaden the availability of PR and maintenance strategies , especially to those living in remote areas and with no access to centre-based exercise programmes . Trial registration Clinical Trials.gov : NCT02258646 In international and national guidelines patient education is recommended as an integral part of an effective management for both , asthma and COPD , respectively . The evaluation of numerous structured education programs for adult asthmatics revealed an increase of quality of life of the educated patients , reduced morbidity with less asthmatic attacks , a decrease of emergency visits , sick leave days and hospitalizations due to asthma . On the basis of cost/benefit analysis cost effectiveness could be demonstrated for education programs for asthmatics . On the basis of education programs in COPD including self-management , in a r and omized controlled study an improvement of the patient 's ability to react to exacerbations could be shown , thus reducing the morbidity by the disease . Further controlled studies of the effects of patient education on morbidity , mortality and cost effectiveness are necessary to establish the role of structured education programs in the treatment of COPD with sufficient validity PURPOSE To examine whether maintenance training ( MT ) for 1 year improved the long-term effects of a 7-week chronic obstructive pulmonary disease ( COPD ) rehabilitation program . METHODS After a 7-week outpatient rehabilitation program , 96 patients with COPD were r and omized to either an MT group ( n = 55 ) or a control group ( n = 41 ) . Both groups were requested to continue unsupervised training at home . The MT group received weekly supervised training the first 6 months , supervised training every second week the next 6 months , and finally no supervised training the last 6 months of the 18-month study period . Primary effect parameters were Endurance Shuttle Walk Test ( ESWT ) time and health status ( St. George 's Respiratory Question naire , SGRQ ) . Secondary effect parameters were adherence to supervised training , dropout rates , and hospitalization . RESULTS Compared with the control group , the MT group had significantly better ESWT times at 3 and 6 months ( + 43.9 seconds ; P= .03 , and + 75.1 seconds ; P= .02 ) and insignificantly higher ESWT time at 12 months ( + 66.6 seconds ; P= .40 ) . SGRQ total score declined gradually after the 7-week program with no difference between the 2 groups , and after 18 months , the score was 1.7 units ( 95 % confidence interval : −0.7 to 4.1 ) worse than at r and omization . There was no difference between the 2 groups regarding dropout rates or hospitalization . DISCUSSION Weekly MT for 12 months improved walking time but had no influence on health-related quality of life or hospital admissions , compared with unsupervised daily training at home . The effect of the MT was closely related to adherence to the program OBJECTIVE To examine the effect of brief disease-specific education delivered in primary care on objective measures of knowledge in individuals recently diagnosed with chronic obstructive pulmonary disease ( COPD ) . METHODS A r and omized control trial was undertaken during which an experimental group received 2h of education delivered by a certified COPD educator and a control group received usual care . The Bristol COPD Knowledge Question naire ( BCKQ ) was self-administered at the time of r and omization and approximately three months later . RESULTS Of the 93 individuals that completed the study , 50 ( forced expiratory volume in 1s [FEV(1)]=60.0+/-14.3 % predicted ; 22 males ) and 43 ( FEV(1)=58.2+/-14.4 % predicted ; 20 males ) participants were r and omized to the experimental and control groups , respectively . The BCKQ increased from 27.6+/-8.7 to 36.5+/-7.7 points ( p<0.001 ) in the experimental group , which was greater than any seen in the control group ( between-group difference 8.3 , 95 % confidence interval 5.5 - 11.2 points ) . CONCLUSION As little as 2h of education delivered in primary care was effective at OUTPUT: The number of behavioural change techniques clusters integrated in the self-management intervention , the duration of the intervention and adaptation of maintenance medication as part of the action plan did not affect HRQoL. Subgroup analyses did not detect any potential variables to explain differences in respiratory-related hospital admissions among studies . Self-management interventions that include a COPD exacerbation action plan are associated with improvements in HRQoL , as measured with the SGRQ , and lower probability of respiratory-related hospital admissions . No excess all-cause mortality risk was observed , but exploratory analysis showed a small , but significantly higher respiratory-related mortality rate for self-management compared to usual care . Although we were unable to evaluate this strategy in this review , it can be expected to further increase the safety of self-management interventions . INPUT: PURPOSE The primary goal of pulmonary rehabilitation ( PR ) is for patients to achieve and maintain their maximum level of independence and functioning in the community . Traditional PR uses a predominantly aerobic/endurance approach to rehabilitation with little or no inclusion of exercises to increase strength . Few studies have investigated the impact of resistance training on PR despite growing evidence supporting its efficacy to improve physical function ( functional fitness ) in both healthy individuals and those with chronic disease . The purpose of this study was to investigate the effect of single-set resistance training on strength and functional fitness outcomes in PR patients . METHODS Twenty PR patients , 60 to 81 years old , were r and omly assigned to an 8-week endurance-based PR program ( ET ) or an ET plus resistance training program ( RT ) . RESULTS Strength increased in RT ( P < .05 ) and decreased in ET for both upper and lower body . Functional fitness improved ( P < .05 ) in 5 of 7 tests for RT compared with 2 tests for ET . CONCLUSIONS Single set RT can elicit significant improvements in both strength and functional fitness , which is not obtained by traditional PR alone . Our results are comparable to other studies with similar outcomes using multiple-set RT protocol s. These findings may have important implication s for program design , application , and adherence in PR & NA ; The purpose of this study was to compare the effects of a strength training‐enhanced program and a traditional pulmonary rehabilitation ( PR ) program on functional fitness ( FF ) in older patients with chronic obstructive pulmonary disease ( COPD ) , using the Senior Fitness Test . Twenty patients were recruited from an outpatient PR program . After completing baseline measures , including muscular strength and the Senior Fitness Test , patients were r and omly assigned to the strength training program ( TR+ST , n = 10 ) or traditional PR program ( TR , n = 10 ) . Patients completed 16 exercise sessions that were conducted twice a week for 8–10 weeks , after which patients repeated outcome measurements . Independent t tests were conducted to determine whether groups differed between measures . Both the TR+ST and TR groups improved on all FF measures . Moderate effect sizes were found for two of the FF measures when the groups were compared . The addition of strength training to PR may have a favorable impact on FF in older patients with COPD Disability and exertional dyspnea associated with chronic obstructive pulmonary disease has led to the development of rehabilitation programmes that aim to increase exercise tolerance and relief of dyspnea . To evaluate whether aerobic training ( training groups P1 and P4 ) , strength training ( P2 and P5 ) or a combination of both ( P4 and P6 ) is useful , 69 patients ( 44 m/25 f ) with moderate to severe COPD were r and omised to a three week inpatient training program . The training consisted of three weekly twenty minute exercise sessions without ( P1 - P3 ) or with supplemental oxygen ( P4 - P6 ) on a calibrated ergocycle ( 70 % W(max ) ) or three weekly sessions of 20 - 25 repetitions of 2 - 4 training series ( 40 % W(max ) ) or a combination of both . In general , the programme failed to demonstrate significant changes in lung function and arterial blood gases . Evaluation of exercise capacity via the six-minute-walking test ( 6MT ) yielded a significant increase of the walking distance in all groups except P2 ( 60 - 83 m ) , The time to finish a test-set of daily activities ( TAF ) was reduced in all groups ( 5 - 58 sec ) and reached significance in P1 , P3 , P5 and P6 . After the 6MT , exertional dyspnea improved in all groups except P4 and was significant in P1 and P3 ; after the TAF , dyspnea again was reduced in all groups with a significant change in P2 and P5 . These data support the hypotheses that a short term inpatient training programme is suitable to improve exercise-capacity and dyspnea . Patients with advanced disease ( P4 - P6 ) show greater benefits with strength training ( alone or in combination with aerobic training ) while for patients with moderate disease ( P1 - P3 ) aerobic training is favourable . These changes may translate into improved performance of daily activities and general well-being The purpose of this study was to evaluate whether strength training is a useful addition to aerobic training in patients with chronic obstructive pulmonary disease ( COPD ) . Forty-five patients with moderate to severe COPD were r and omized to 12 wk of aerobic training alone ( AERO ) or combined with strength training ( AERO + ST ) . The AERO regimen consisted of three weekly 30-min exercise sessions on a calibrated ergocycle , and the ST regimen included three series of eight to 10 repetitions of four weight lifting exercises . Measurements of peripheral muscle strength , thigh muscle cross-sectional area ( MCSA ) by computed tomographic scanning , maximal exercise capacity , 6-min walking distance ( 6MWD ) , and quality of life with the chronic respiratory question naire were obtained at baseline and after training . Thirty-six patients completed the program and constituted the study group . The strength of the quadriceps femoris increased significantly in both groups ( p < 0.05 ) , but the improvement was greater in the AERO + ST group ( 20 + /- 12 % versus 8 + /- 10 % [ mean + /- SD ] in the AERO group , p < 0.005 ) . The thigh MCSA and strength of the pectoralis major muscle increased in the AERO + ST group by 8 + /- 13 % and 15 + /- 9 % , respectively ( p < 0.001 ) , but not in the AERO group ( 3 + /- 6 % and 2 + /- 10 % , respectively , p > 0.05 ) . These changes were significantly different in the two study groups ( p < 0.01 ) . The increase in strength of the latissimus dorsi muscle after OUTPUT:

We included 11 r and omized controlled trials ( 331 participants ) and 2 previous systematic review s. The meta-analyses showed equal improvements in HRQoL , walking distance and exercise capacity . In conclusion , we found significantly increased leg muscle strength favouring a combination of RT with ET compared with ET alone .

MS2_dynamic_1_shot46

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Attention Deficit Hyperactivity Disorder ( ADHD ) is characterized by poor cognitive control/attention and hypofunctioning of the dorsal anterior cingulate cortex ( dACC ) . In the current study , we investigated for the first time whether real-time fMRI neurofeedback ( rt-fMRI ) training targeted at increasing activation levels within dACC in adults with ADHD leads to a reduction of clinical symptoms and improved cognitive functioning . An exploratory r and omized controlled treatment study with blinding of the participants was conducted . Participants with ADHD ( n = 7 in the neurofeedback group , and n = 6 in the control group ) attended four weekly MRI training sessions ( 60-min training time/session ) , during which they performed a mental calculation task at varying levels of difficulty , in order to learn how to up-regulate dACC activation . Only neurofeedback participants received continuous feedback information on actual brain activation levels within dACC . Before and after the training , ADHD symptoms and relevant cognitive functioning was assessed . Results showed that both groups achieved a significant increase in dACC activation levels over sessions . While there was no significant difference between the neurofeedback and control group in clinical outcome , neurofeedback participants showed stronger improvement on cognitive functioning . The current study demonstrates the general feasibility of the suggested rt-fMRI neurofeedback training approach as a potential novel treatment option for ADHD patients . Due to the study ’s small sample size , potential clinical benefits need to be further investigated in future studies . Trial Registration : IS RCT Many patients show no or incomplete responses to current pharmacological or psychological therapies for depression . Here we explored the feasibility of a new brain self-regulation technique that integrates psychological and neurobiological approaches through neurofeedback with functional magnetic resonance imaging ( fMRI ) . In a proof-of-concept study , eight patients with depression learned to upregulate brain areas involved in the generation of positive emotions ( such as the ventrolateral prefrontal cortex ( VLPFC ) and insula ) during four neurofeedback sessions . Their clinical symptoms , as assessed with the 17-item Hamilton Rating Scale for Depression ( HDRS ) , improved significantly . A control group that underwent a training procedure with the same cognitive strategies but without neurofeedback did not improve clinical ly . R and omised blinded clinical trials are now needed to exclude possible placebo effects and to determine whether fMRI-based neurofeedback might become a useful adjunct to current therapies for depression Background : Spider phobics show an exaggerated fear response when encountering spiders . This fear response is aggravated by negative and irrational beliefs about the feared object . Cognitive re appraisal can target these beliefs , and therefore has a fear regulating effect . The presented study investigated if neurofeedback derived from functional magnetic resonance imaging ( fMRI ) would facilitate anxiety regulation by cognitive re appraisal , using spider phobia as a model of anxiety disorders . Feedback was provided based on activation in left dorsolateral prefrontal cortex and right insula , as indicators of engagement and regulation success , respectively . Methods : Eighteen female spider phobics participated in a r and omized , controlled , single-blinded study . All participants completed a training session in the MRI scanner . Participants assigned to the neurofeedback condition were instructed to shape their regulatory strategy based on the provided feedback . Participants assigned to the control condition were asked to adapt their strategy intuitively . Results : Neurofeedback participants exhibited lower anxiety levels than the control group at the end of the training . In addition , only neurofeedback participants achieved down-regulation of insula activation levels by cognitive re appraisal . Group differences became more pronounced over time , supporting learning as a mechanism behind this effect . Importantly , within the neurofeedback group , achieved changes in insula activation levels during training predicted long-term anxiety reduction . Conclusions : The conducted study provides first evidence that fMRI neurofeedback has a facilitating effect on anxiety regulation in spider phobia If an individual can learn to directly control activation of localized regions within the brain , this approach might provide control over the neurophysiological mechanisms that mediate behavior and cognition and could potentially provide a different route for treating disease . Control over the endogenous pain modulatory system is a particularly important target because it could enable a unique mechanism for clinical control over pain . Here , we found that by using real-time functional MRI ( rtfMRI ) to guide training , subjects were able to learn to control activation in the rostral anterior cingulate cortex ( rACC ) , a region putatively involved in pain perception and regulation . When subjects deliberately induced increases or decreases in rACC fMRI activation , there was a corresponding change in the perception of pain caused by an applied noxious thermal stimulus . Control experiments demonstrated that this effect was not observed after similar training conducted without rtfMRI information , or using rtfMRI information derived from a different brain region , or sham rtfMRI information derived previously from a different subject . Chronic pain patients were also trained to control activation in rACC and reported decreases in the ongoing level of chronic pain after training . These findings show that individuals can gain voluntary control over activation in a specific brain region given appropriate training , that voluntary control over activation in rACC leads to control over pain perception , and that these effects were powerful enough to impact severe , chronic clinical pain Abstract Attention Deficit Hyperactivity Disorder ( ADHD ) is associated with poor self‐control , underpinned by inferior fronto‐striatal deficits . Real‐time functional magnetic resonance neurofeedback ( rtfMRI‐NF ) allows participants to gain self‐control over dysregulated brain regions . Despite evidence for beneficial effects of electrophysiological‐NF on ADHD symptoms , no study has applied the spatially superior rtfMRI‐NF neurotherapy to ADHD . A r and omized controlled trial tested the efficacy of rtfMRI‐NF of right inferior prefrontal cortex ( rIFG ) , a key region that is compromised in ADHD and upregulated with psychostimulants , on improvement of ADHD symptoms , cognition , and inhibitory fMRI activation . To control for region‐specificity , an active control group OUTPUT: The vast majority of fMRI‐nf findings suggest that self‐regulation of specific brain signatures seems viable ; however , replication of concomitant behavioral outcomes remains sparse . We can certainly change brain activity with fMRI‐nf . HighlightsWe conducted a systematic review of 99 fMRI neurofeedback ( fMRI‐nf ) experiments.fMRI‐nf successfully drives BOLD regulation and behavioral change . BOLD regulation guarantees neither neural regulation nor clinical improvement . Psychosocial factors may contribute to regulation of BOLD signal and behavior . INPUT: Electroencephalography (EEG)-neurofeedback has been shown to offer therapeutic benefits to patients with attention-deficit/hyperactivity disorder ( ADHD ) in several , mostly uncontrolled studies . This pilot study is design ed to test the feasibility and safety of using a double-blind placebo feedback-controlled design and to explore the initial efficacy of individualized EEG-neurofeedback training in children with ADHD . Fourteen children ( 8–15 years ) with ADHD defined according to the DSM-IV-TR criteria were r and omly allocated to 30 sessions of EEG-neurofeedback ( n = 8) or placebo feedback ( n = 6 ) . Safety measures ( adverse events and sleep problems ) , ADHD symptoms and global improvement were monitored . With respect to feasibility , all children completed the study and attended all study visits and training sessions . No significant adverse effects or sleep problems were reported . Regarding the expectancy , 75 % of children and their parent(s ) in the active neurofeedback group and 50 % of children and their parent(s ) in the placebo feedback group thought they received placebo feedback training . Analyses revealed significant improvements of ADHD symptoms over time , but changes were similar for both groups . This pilot study shows that it is feasible to conduct a rigorous placebo-controlled trial to investigate the efficacy of neurofeedback training in children with ADHD . However , a double-blind design may not be feasible since using automatic adjusted reward thresholds may not work as effective as manually adjusted reward thresholds . Additionally , implementation of active learning strategies may be an important factor for the efficacy of EEG-neurofeedback training . Based on the results of this pilot study , changes are made in the design of the ongoing study Neurofeedback treatment has been demonstrated to reduce inattention , impulsivity and hyperactivity in children with attention deficit/hyperactivity disorder ( ADHD ) . However , previous studies did not adequately control confounding variables or did not employ a r and omized reinforcer-controlled design . This study addresses those method ological shortcomings by comparing the effects of the following two matched biofeedback training variants on the primary symptoms of ADHD : EEG neurofeedback ( NF ) aim ing at theta/beta ratio reduction and EMG biofeedback ( BF ) aim ing at forehead muscle relaxation . Thirty-five children with ADHD ( 26 boys , 9 girls ; 6–14 years old ) were r and omly assigned to either the therapy group ( NF ; n = 18 ) or the control group ( BF ; n = 17 ) . Treatment for both groups consisted of 30 sessions . Pre- and post-treatment assessment consisted of psychophysiological measures , behavioural rating scales completed by parents and teachers , as well as psychometric measures . Training effectively reduced theta/beta ratios and EMG levels in the NF and BF groups , respectively . Parents reported significant reductions in primary ADHD symptoms , and inattention improvements in the NF group were higher compared to the control intervention ( BF , dcorr = −.94 ) . NF training also improved attention and reaction times on the psychometric measures . The results indicate that NF effectively reduced inattention symptoms on parent rating scales and reaction time in neuropsychological tests . However , regarding hyperactivity and impulsivity symptoms , the results imply that non-specific factors , such as behavioural contingencies , self-efficacy , structured learning environment and feed-forward processes , may also contribute to the positive behavioural effects induced by neurofeedback training Objective : Preparing for a definitive r and omized clinical trial ( RCT ) of neurofeedback ( NF ) for ADHD , this pilot trial explored feasibility of a double-blind , sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week . Method : Unmedicated 6- to 12-year-olds with Diagnostic and Statistical Manual of Mental Disorders ( 4th ed . ; DSM-IV ) ADHD were r and omized to active NF versus sham-NF and to 2X versus 3X/week treatment frequency . Frequency switch was allowed after Treatment 24 . Results : In two school years , 39 participants were recruited and 34 ( 87 % ) completed all 40 treatments . Child/parent guesses about assigned treatment were no better than chance . At Treatment 24 , 38 % chose 2X/week and 62 % chose 3X/week . Both active NF and sham yielded large pre – post improvement on parent ratings but NF no more than sham . Conclusion : Blinding appears to work , and sham does not prevent recruitment/retention . Treatment frequency of 3X/week seems preferred over 2X/week and was as effective . A large double-blind RCT is feasible and necessary to test specific NF effectiveness OBJECTIVE : To evaluate sustained improvements 6 months after a 40-session , in-school computer attention training intervention using neurofeedback or cognitive training ( CT ) administered to 7- to 11-year-olds with attention-deficit/hyperactivity disorder ( ADHD ) . METHODS : One hundred four children were r and omly assigned to receive neurofeedback , CT , or a control condition and were evaluated 6 months postintervention . A 3-point growth model assessed change over time across the conditions on the Conners 3–Parent Assessment Report ( Conners 3-P ) , the Behavior Rating Inventory of Executive Function Parent Form ( BRIEF ) , and a systematic double-blinded classroom observation ( Behavioral Observation of Students in Schools ) . Analysis of variance assessed community-initiated changes in stimulant medication . RESULTS : Parent response rates were 90 % at the 6-month follow-up . Six months postintervention , neurofeedback participants maintained significant gains on Conners 3-P ( Inattention effect size [ ES ] = 0.34 , Executive Functioning ES = 0.25 , Hyperactivity/Impulsivity ES = 0.23 ) and BRIEF subscales including the Global Executive Composite ( ES = 0.31 ) , which remained significantly greater than g OUTPUT:

Conclusions : This meta- analysis of EEG-NF in children with ADHD highlights improvement in the inattention dimension of ADHD symptoms .

MS2_dynamic_1_shot47

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Gut microbiota is now known to control glucose metabolism . Previous studies have shown that probiotics and prebiotics may improve glucose metabolism , but their effects have not been studied in combination with drug therapy . The aim of this study was to investigate whether probiotics and prebiotics combined with drug therapy affect diabetic outcomes . Methods Two different study design s were used to test gut microbiota modulating treatments with metformin ( MET ) or sitagliptin ( SITA ) in male C57Bl/6J mice . In Design 1 , diabetes was induced with four-week feeding with a ketogenic , 72 kcal% fat diet with virtually no carbohydrates . Mice were then r and omly divided into four groups ( n = 10 in each group ) : ( 1 ) vehicle , ( 2 ) Bifidobacterium animalis ssp . lactis 420 ( B420 ) ( 109 CFU/day ) , ( 3 ) MET ( 2 mg/mL in drinking water ) , or ( 4 ) MET + B420 ( same doses as in the MET and B420 groups ) . After another 4 weeks , glucose metabolism was assessed with a glucose tolerance test . Fasting glucose , fasting insulin and HOMA-IR were also assessed . In Design 2 , mice were fed the same 72 kcal% fat diet to induce diabetes , but they were simultaneously treated within their respective groups ( n = 8 in each group ) : ( 1 ) non-diabetic healthy control , ( 2 ) vehicle , ( 3 ) SITA [ 3 mg/(kg*day ) ] ( 4 ) SITA with prebiotic polydextrose ( PDX ) ( 0.25 g/day ) , ( 5 ) SITA with B420 ( 109 CFU/day ) , and ( 6 ) SITA + PDX + B420 . Glucose metabolism was assessed at 4 weeks , and weight development was monitored for 6 weeks . Results In Design 1 , with low-dose metformin , mice treated with B420 had a significantly lower glycemic response ( area under the curve ) ( factorial experiment , P = 0.002 ) and plasma glucose concentration ( P = 0.02 ) compared to mice not treated with B420 . In Design 2 , SITA + PDX reduced glycaemia in the oral glucose tolerance test significantly more than SITA only ( area under the curve reduced 28 % , P < 0.0001 ) . In addition , B420 , PDX or B420+PDX , together with SITA , further decreased fasting glucose concentrations compared to SITA only ( −19.5 , −40 and −49 % , respectively , P < 0.01 for each comparison ) . The effect of PDX may be due to its ability to increase portal vein GLP-1 concentrations together with SITA ( P = 0.0001 compared to vehicle ) whereas SITA alone had no statistically significant effect compared to vehicle ( P = 0.14 ) . Conclusions This study proposes that combining probiotics and /or prebiotics with antidiabetic drugs improves glycemic control and insulin sensitivity in mice . Mechanisms could be related to incretin secretion Background Recently , the relationship between gut microbiota and obesity has been highlighted . The present r and omized , double-blind , placebo-controlled study aim ed to evaluate the efficacy of transglucosidase ( TGD ) in modulating blood glucose levels and body weight gain in patients with type 2 diabetes mellitus ( T2DM ) and to clarify the underlying mechanism by analyzing the gut microbiota of T2DM patients . Methods This study included 60 patients who received placebo or TGD orally ( 300 or 900 mg/day ) for 12 weeks , and blood and fecal sample s were collected before and after 12 weeks . Comparisons of fecal bacterial communities were performed before and after the TGD treatment and were performed between T2DM patients and 10 healthy individuals , using the terminal-restriction fragment length polymorphism analysis . Results The Clostridium cluster IV and subcluster XIVa components were significantly decreased , whereas the Lactobacillales and Bifidobacterium population s significantly increased in the T2DM patients compared with the healthy individuals . By dendrogram analysis , most of the healthy individuals ( 6/10 ) and T2DM patients ( 45/60 ) were classified into cluster I , indicating no significant difference in fecal bacterial communities between the healthy individuals and the T2DM patients . In the placebo and TGD groups , the bacterial communities were generally similar before and after the treatment . However , after 12 weeks of TGD therapy , the Bacteroidetes-to-Firmicutes ratio in the TGD groups significantly increased and was significantly higher compared with that in the placebo group , indicating that TGD improved the growth of the fecal bacterial communities in the T2DM patients . Conclusions Therefore , TGD treatment decreased blood glucose levels and prevented body weight gain in the T2DM patients by inducing the production of oligosaccharides in the alimentary tract and modulating gut microbiota composition . Trial registration UMIN-CTR A high-fat diet ( HFD ) induces obesity and the associated increases in blood glucose and inflammation through changes in gut microbiota , endotoxemia , and increased gut permeability . To counteract this , research ers have suggested that the use of probiotics that suppress production of proinflammatory lipopolysaccharide ( LPS ) . Here , we tested whether Lactobacillus sakei OK67 , which inhibits gut microbiota LPS production selected from among the lactic acid bacteria isolated from kimchi , exerted antihypoglycemic or anti-inflammatory effects in HFD-f OUTPUT: Among the commonly reported findings , the genera of Bifidobacterium , Bacteroides , Faecalibacterium , Akkermansia and Roseburia were negatively associated with T2D , while the genera of Ruminococcus , Fusobacterium , and Blautia were positively associated with T2D . INPUT: BACKGROUND According to previous studies , probiotic and prebiotic supplementation have desirable effects on glycemic parameters . Thus far , the effect of supplementation on the glycemic parameters and adipokines in non-alcoholic fatty liver disease ( NAFLD ) has not been assessed . Therefore , the aim of this study was to determine the effects of supplementation with probiotic and prebiotic on adiokines and glycemic parameters in the patients with NAFLD . METHODS In the present r and omized , double-blind , placebo-controlled trial , 89 patients with NAFLD were r and omly divided into three groups to receive one probiotic capsule + 16 g/d maltodextrin ( probiotic group ) or 16 g/d oligofructose powder + one placebo capsule ( prebiotic group ) , and one placebo capsule + 16 g/d maltodextrin ( control group ) for 12 weeks . All the subjects in the study were advised to follow the weight loss diet and physical activity recommendations during the intervention . Fasting blood sample s were taken at baseline and after the intervention to measure leptin , adiponectin , insulin , and fasting blood sugar . RESULTS At the end of the study , serum concentrations of leptin , insulin , and HOMA-IR decreased significantly in the probiotic and prebiotic groups compared with the control group . Despite the changes within the groups , serum concentrations of adiponectin did not change significantly between the three groups . Also , fasting blood sugar did not change between the groups , but decreased in the prebiotic group . Quantitative insulin-sensitivity check index ( QUICKI ) increased significantly in probiotic and prebiotic groups compared with the control group . CONCLUSION Probiotic and prebiotic supplementation along with lifestyle intervention has a favorable impact on glycemic parameters and leptin levels compared with lifestyle intervention alone BACKGROUND Multiple organ dysfunction syndrome ( MODS ) is a major cause of mortality in intensive care units . A breakdown in gut barrier function and immune dysfunction are associated with the onset of MODS . Probiotic bacteria have been shown to modulate intestinal barrier and immune function . OBJECTIVE This study assessed the efficacy of a probiotic compound in a viable and nonviable formulation in modulating intestinal permeability and immune function and preventing the onset of MODS in patients in the intensive care unit . DESIGN A double-blind , r and omized controlled trial was conducted in the intensive care unit of a tertiary care teaching hospital . Twenty-eight critically ill patients admitted to the intensive care unit were r and omly assigned to receive 1 of 3 treatments daily for 7 d : 1 ) placebo , 2 ) viable probiotics , or 3 ) equivalent probiotic sonicates . MODS scores and systemic concentrations of immunoglobulin ( Ig ) A and IgG were measured on days -1 , 4 , and 7 , and intestinal permeability measurements were taken daily . RESULTS The patients responded to viable probiotics with a significantly larger increase in systemic IgA and IgG concentrations than in the patients who received placebo or sonicates ( P < 0.05 ) . MODS scores were not significantly affected by probiotic treatment . Over the study period , intestinal permeability decreased in most patients . CONCLUSION Patients receiving viable probiotics show a greater enhancement in immune activity than do patients receiving either placebo or probiotic bacterial sonicates BACKGROUND & AIMS Probiotics can reduce symptoms of irritable bowel syndrome ( IBS ) , but little is known about their effects on psychiatric comorbidities . We performed a prospect i ve study to evaluate the effects of Bifidobacterium longum NCC3001 ( BL ) on anxiety and depression in patients with IBS . METHODS We performed a r and omized , double-blind , placebo-controlled study of 44 adults with IBS and diarrhea or a mixed-stool pattern ( based on Rome III criteria ) and mild to moderate anxiety and /or depression ( based on the Hospital Anxiety and Depression scale ) at McMaster University in Canada , from March 2011 to May 2014 . At the screening visit , clinical history and symptoms were assessed and blood sample s were collected . Patients were then r and omly assigned to groups and given daily BL ( n = 22 ) or placebo ( n = 22 ) for 6 weeks . At weeks 0 , 6 , and 10 , we determined patients ' levels of anxiety and depression , IBS symptoms , quality of life , and somatization using vali date d question naires . At weeks 0 and 6 , stool , urine and blood sample s were collected , and functional magnetic resonance imaging ( fMRI ) test was performed . We assessed brain activation patterns , fecal microbiota , urine metabolome profiles , serum markers of inflammation , neurotransmitters , and neurotrophin levels . RESULTS At week 6 , 14 of 22 patients in the BL group had reduction in depression scores of 2 points or more on the Hospital Anxiety and Depression scale , vs 7 of 22 patients in the placebo group ( P = .04 ) . BL had no significant effect on anxiety or IBS symptoms . Patients in the BL group had a mean increase in quality of life score compared with the placebo group . The fMRI analysis showed that BL reduced responses to negative emotional stimuli in multiple brain areas , including amygdala and fronto-limbic regions , compared with placebo . The groups had similar fecal microbiota profiles , serum markers of inflammation , and levels of neurotrophins and neurotransmitters , but the BL group had reduced urine levels of methylamines and aromatic amino acids metabolites . At week 10 , depression scores were reduced in patients given BL vs placebo . CONCLUSION In a placebo-control OUTPUT:

Conclusions Probiotic supplementation significantly reduced serum concentrations of pro-inflammatory cytokines including , hs-CRP , TNF-a , IL-6 , IL-12 , and IL-4 , but it did not influence IL-1B , IL-8 , IFN-g , and IL-17 concentrations . A significant increase in serum concentrations of IL-10 , as a anti-inflammatory cytokine was also documented after probiotic supplementation

MS2_dynamic_1_shot48

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Earlier diagnosis followed by multi-factorial cardiovascular risk intervention may improve outcomes in Type 2 Diabetes Mellitus ( T2DM ) . Latent phase identification through screening requires structured , appropriately targeted population -based approaches . Providers responsible for implementing screening policy await evidence of clinical and cost effectiveness from r and omised intervention trials in screen-detected T2DM cases . UK South Asians are at particularly high risk of abnormal glucose tolerance and T2DM . To be effective national screening programmes must achieve good coverage across the population by identifying barriers to the detection of disease and adapting to the delivery of earlier care . Here we describe the rationale and methods of a systematic community screening programme and r and omised controlled trial of cardiovascular risk management within a UK multiethnic setting ( ADDITION-Leicester ) . Design A single-blind cluster r and omised , parallel group trial among people with screen-detected T2DM comparing a protocol driven intensive multi-factorial treatment with conventional care . Methods ADDITION-Leicester consists of community-based screening and intervention phases within 20 general practice s coordinated from a single academic research centre . Screening adopts a universal diagnostic approach via repeated 75g-Oral Glucose Tolerance Tests within an eligible non-diabetic population of 66,320 individuals aged 40 - 75 years ( 25 - 75 years South Asian ) . Volunteers also provide detailed medical and family histories ; complete health question naires , undergo anthropometric measures , lipid profiling and a proteinuria assessment . Primary outcome is reduction in modelled Coronary Heart Disease ( UKPDS CHD ) risk at five years . Seven thous and ( 30 % of South Asian ethnic origin ) volunteers over three years will be recruited to identify a screen-detected T2DM cohort ( n = 285 ) powered to detected a 6 % relative difference ( 80 % power , alpha 0.05 ) between treatment groups at one year . R and omisation will occur at practice -level with newly diagnosed T2DM cases receiving either conventional ( according to current national guidelines ) or intensive ( algorithmic target-driven multi-factorial cardiovascular risk intervention ) treatments . Discussion ADDITION-Leicester is the largest multiethnic ( targeting > 30 % South Asian recruitment ) community T2DM and vascular risk screening programme in the UK . By assessing feasibility and efficacy of T2DM screening , it will inform national disease prevention policy and contribute significantly to our underst and ing of the health care needs of UK South Asians . Trial registration Clinical trial.gov ( NCT00318032 ) Objective To quantify the psychological impact of primary care based stepwise screening for type 2 diabetes . Design Controlled trial and comparative study embedded in a r and omised controlled trial . Setting 15 practice s ( 10 screening , five control ) in the ADDITION ( Cambridge ) trial in the east of Engl and . Participants 7380 adults ( aged 40 - 69 ) in the top fourth for risk of having undiagnosed type 2 diabetes ( 6416 invited for screening , 964 controls ) . Interventions Invited for screening for type 2 diabetes or not invited ( controls ) , incorporating a comparative study of subgroups of screening attenders . Attenders completed question naires after a r and om blood glucose test and at 3 - 6 months and 12 - 15 months later . Controls were sent question naires at corresponding time points . Non-attenders were sent question naires at 3 - 6 months and 12 - 15 months . Main outcome measures State anxiety ( Spielberger state anxiety inventory ) , anxiety and depression ( hospital anxiety and depression scale ) , worry about diabetes , and self rated health . Results No significant differences were found between the screening and control participants at any time — for example , difference in means ( 95 % confidence intervals ) for state anxiety after the initial blood glucose test was −0.53 , −2.60 to 1.54 , at 3 - 6 months was 1.51 ( −0.17 to 3.20 ) , and at 12 - 15 months was 0.57 , −1.11 to 2.24 . After the initial test , compared with participants who screened negative , those who screened positive reported significantly poorer general health ( difference in means −0.19 , −0.25 to −0.13 ) , higher state anxiety ( 0.93 , −0.02 to 1.88 ) , higher depression ( 0.32 , 0.08 to 0.56 ) , and higher worry about diabetes ( 0.25 , 0.09 to 0.41 ) , although effect sizes were small . Small but significant trends were found for self rated health across the screening subgroups at 3 - 6 months ( P=0.047 ) and for worry about diabetes across the screen negative groups at 3 - 6 months and 12 - 15 months ( P=0.001 ) . Conclusions Screening for type 2 diabetes has limited psychological impact on patients . Implementing a national screening programme based on the stepwise screening procedure used in the ADDITION ( Cambridge ) trial is unlikely to have significant consequences for patients ' psychological health . Trial registration Current Controlled Trials IS RCT N99175498 Highlights • We examined individuals with screen-detected diabetes over five years.• Two cardio-protective agents were prescribed at diagnosis , 3 at one year and 4 at five years.• Increases in cardio-protective medication did not impact negatively on Objective To examine the prevalence of outcome reporting bias — the selection for publication of a subset of the original recorded outcome variables on the basis of the results — and its impact on Cochrane review s. Design A nine point classification system for missing outcome data in r and omised trials was developed and applied to the trials assessed in a large , unselected cohort of Cochrane systematic review s. Research ers who conducted the tri OUTPUT: Diabetes-related morbidity and health-related quality of life were only reported in a sub sample and did not show a substantial difference between the screening intervention and control . AUTHORS ' CONCLUSIONS We are uncertain about the effects of screening for type 2 diabetes on all-cause mortality and diabetes-related mortality . We are therefore unable to draw any firm conclusions relating to the health outcomes of early type 2 diabetes mellitus screening . INPUT: Type 2 diabetes ( T2D ) is associated with increased risk of morbidity and premature mortality . Among those at high risk , incidence can be halved through healthy changes in behaviour . Information about genetic and phenotypic risk of T2D is now widely available . Whether such information motivates behaviour change is unknown . We aim to assess the effects of communicating genetic and phenotypic risk of T2D on risk-reducing health behaviours , anxiety , and other cognitive and emotional theory-based antecedents of behaviour change . In a parallel group , open r and omised controlled trial , approximately 580 adults born between 1950 and 1975 will be recruited from the on-going population -based , observational Fenl and Study ( Cambridgeshire , UK ) . Eligible participants will have undergone clinical , anthropometric , and psychosocial measurements , been genotyped for 23 single-nucleotide polymorphisms associated with T2D , and worn a combined heart rate monitor and accelerometer ( Actiheart ® ) continuously for six days and nights to assess physical activity . Participants are r and omised to receive either st and ard lifestyle advice alone ( control group ) , or in combination with a genetic or a phenotypic risk estimate for T2D ( intervention groups ) . The primary outcome is objective ly measured physical activity . Secondary outcomes include self-reported diet , self-reported weight , intention to be physically active and to engage in a healthy diet , anxiety , diabetes-related worry , self-rated health , and other cognitive and emotional outcomes . Follow-up occurs eight weeks post-intervention . Values at follow-up , adjusted for baseline , will be compared between r and omised groups . This study will provide much needed evidence on the effects of providing information about the genetic and phenotypic risk of T2D . Importantly , it will be among the first to examine the impact of genetic risk information using a r and omised controlled trial design , a population -based sample , and an objective ly measured behavioural outcome . Results of this trial , along with recent evidence syntheses of similar studies , should inform policy concerning the availability and use of genetic risk information . Current Controlled Trials IS RCT Background There are few empirical data to inform the debate surrounding the use and regulation of direct-to-consumer ( DTC ) genome-wide disease risk tests . This study aim ed to determine the long term psychological , behavioural , and clinical impacts of genomic risk testing for common disease . Methods The Scripps Genomic Health Initiative is a prospect i ve longitudinal cohort study of adults who purchased the Navigenics Health Compass , a commercially available genomic test . Web based assessment s were administered at baseline , short ( 3 months ) , and long term ( 1 year ) follow-up . Results 2240 participants completed either or both follow-ups and a subset of 1325 completed long term follow-up . There were no significant differences from baseline in anxiety ( p=0.50 ) , fat intake ( p=0.34 ) , or exercise ( p=0.39 ) at long term follow-up , and 96.8 % of the sample had no test related distress . Longitudinal linear mixed model analyses were consistent with results of cross-sectional analyses . Screening test completion was associated with sharing genomic test results with a physician ( 36.0 % shared ; p<0.001 ) and perceived utility of the test ( 61.5 % high perceived utility ; p=0.002 ) , but was not associated with the genomic risk estimate values themselves . Conclusions Over a third of DTC genomic test recipients shared their results with their own physician during an approximate 1 year follow-up period , and this sharing was associated with higher screening test completion . Genomic testing was not associated with long term psychological risks , and most participants reportedly perceived the test to be of high personal utility Objectives To assess the performance of a panel of common single nucleotide polymorphisms ( genotypes ) associated with type 2 diabetes in distinguishing incident cases of future type 2 diabetes ( discrimination ) , and to examine the effect of adding genetic information to previously vali date d non-genetic ( phenotype based ) models developed to estimate the absolute risk of type 2 diabetes . Design Workplace based prospect i ve cohort study with three 5 yearly medical screenings . Participants 5535 initially healthy people ( mean age 49 years ; 33 % women ) , of whom 302 developed new onset type 2 diabetes over 10 years . Outcome measures Non-genetic variables included in two established risk models — the Cambridge type 2 diabetes risk score ( age , sex , drug treatment , family history of type 2 diabetes , body mass index , smoking status ) and the Framingham offspring study type 2 diabetes risk score ( age , sex , parental history of type 2 diabetes , body mass index , high density lipoprotein cholesterol , triglycerides , fasting glucose)— and 20 single nucleotide polymorphisms associated with susceptibility to type 2 diabetes . Cases of incident type 2 diabetes were defined on the basis of a st and ard oral glucose tolerance test , self report of a doctor ’s diagnosis , or the use of anti-diabetic drugs . Results A genetic score based on the number of risk alleles carried ( range 0 - 40 ; area under receiver operating characteristics curve 0.54 , 95 % confidence interval 0.50 to 0.58 ) and a genetic risk function in which carriage of risk alleles was weighted according to the summary odds ratios of their effect from meta-analyses of genetic studies ( area under receiver operating characteristics curve 0.55 , 0.51 to 0.59 ) did not effectively discriminate cases of diabetes . The Cambridge risk score ( area under curve 0.72 , 0.69 to 0.76 ) and the Framingham offspring risk score ( area under curve 0.78 , 0.75 to 0.82 ) led to better discrimination of cases than did genotype based tests . Adding genetic information to OUTPUT:

This review found no clear or consistent evidence that genetic risk communication alone either raises motivation or translates into actual change in dietary intake or physical activity to reduce the risk of cardiometabolic disorders in adults .

MS2_dynamic_1_shot49

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: We examined the effects of citric acid and l-carnitine administration on physical fatigue . In a double-blind , placebo-controlled , 3-way crossover study , 18 healthy volunteers were r and omized to oral citric acid ( 2,700 mg/day ) , l-carnitine ( 1,000 mg/day ) , or placebo for 8 days . The fatigue-inducing physical task consisted of workload trials on a cycle ergometer at fixed workloads for 2 h on 2 occasions . Before the physical load , salivary chromogranin A , measured as a physiological stress marker , was lower in the group given citric acid than in the group given placebo . Also , after the physical load , the subjective feeling of fatigue assessed with a visual analogue scale was lower in the citric acid group than in the placebo group . In contrast , l-carnitine had no effect on chromogranin A or subjective fatigue . These results suggest that citric acid reduces physiological stress and attenuates physical fatigue , whereas l-carnitine does not Background The purpose of this study was to examine the effect of acute and prolonged ( 4-weeks ) ingestion of a supplement design ed to improve reaction time and subjective measures of alertness , energy , fatigue , and focus compared to placebo . Methods Nineteen physically-active subjects ( 17 men and 2 women ) were r and omly assigned to a group that either consumed a supplement ( 21.1 ± 0.6 years ; body mass : 80.6 ± 9.4 kg ) or placebo ( 21.3 ± 0.8 years ; body mass : 83.4 ± 18.5 kg ) . During the initial testing session ( T1 ) , subjects were provided 1.5 g of the supplement ( CRAM ; α-glycerophosphocholine , choline bitartrate , phosphatidylserine , vitamins B3 , B6 , and B12 , folic acid , L-tyrosine , anhydrous caffeine , acetyl-L-carnitine , and naringin ) or a placebo ( PL ) , and rested quietly for 10-minutes before completing a question naire on subjective feelings of energy , fatigue , alertness and focus ( PRE ) . Subjects then performed a 4-minute quickness and reaction test followed by a 10-min bout of exhaustive exercise . The question naire and reaction testing sequence was then repeated ( POST ) . Subjects reported back to the lab ( T2 ) following 4-weeks of supplementation and repeated the testing sequence . Results Reaction time significantly declined ( p = 0.050 ) between PRE and POST at T1 in subjects consuming PL , while subjects under CRAM supplementation were able to maintain ( p = 0.114 ) their performance . Significant performance declines were seen in both groups from PRE to POST at T2 . Elevations in fatigue were seen for CRAM at both T1 and T2 ( p = 0.001 and p = 0.000 , respectively ) , but only at T2 for PL ( p = 0.029 ) . Subjects in CRAM maintained focus between PRE and POST during both T1 and T2 trials ( p = 0.152 and p = 0.082 , respectively ) , whereas significant declines in focus were observed between PRE and POST in PL at both trials ( p = 0.037 and p = 0.014 , respectively ) . No difference in alertness was seen at T1 between PRE and POST for CRAM ( p = 0.083 ) , but a significant decline was recorded at T2 ( p = 0.005 ) . Alertness was significantly lower at POST at both T1 and T2 for PL ( p = 0.040 and p = 0.33 , respectively ) . No differences in any of these subjective measures were seen between the groups at any time point . Conclusion Results indicate that acute ingestion of CRAM can maintain reaction time , and subjective feelings of focus and alertness to both visual and auditory stimuli in healthy college students following exhaustive exercise . However , some habituation may occur following 4-weeks of supplementation BACKGROUND Centenarians are characterized by weakness , decreasing mental health , impaired mobility , and poor endurance . L-Carnitine is an important contributor to cellular energy metabolism . OBJECTIVE This study evaluated the efficacy of L-carnitine on physical and mental fatigue and on cognitive functions of centenarians . DESIGN This was a placebo-controlled , r and omized , double-blind , 2-phase study . Sixty-six centenarians with onset of fatigue after even slight physical activity were recruited to the study . The 2 groups received either 2 g levocarnitine once daily ( n = 32 ) or placebo ( n = 34 ) . Efficacy measures included changes in total fat mass , total muscle mass , serum triacylglycerol , total cholesterol , HDL cholesterol , LDL cholesterol , Mini-Mental State Examination ( MMSE ) , Activities of Daily Living , and a 6-min walking corridor test . RESULTS At the end of the study period , the levocarnitine-treated centenarians , compared with the placebo group , showed significant improvements in the following markers : total fat mass ( -1.80 compared with 0.6 kg ; P < 0.01 ) , total muscle mass ( 3.80 compared with 0.8 kg ; P < 0.01 ) , plasma concentrations of total carnitine ( 12.60 compared with -1.70 mumol ; P < 0.05 ) , plasma long-chain acylcarnitine ( 1.50 compared with -0.1 micromol ; P < 0.001 ) , and plasma short-chain acylcarnitine ( 6.0 compared with -1.50 micromol ; P < 0.001 ) . Sign OUTPUT: Due to the limited number of included trials , short-term treatment , and inadequate reporting , we were unable to draw any conclusions about the efficacy or safety of L-carnitine for cognitive enhancement in healthy adults . INPUT: OBJECTIVE To determine whether acetyl-L-carnitine ( ALC ) , a metabolite necessary for energy metabolism and essential fatty acid anabolism , might help attention-deficit/hyperactivity disorder ( ADHD ) . Trials in Down 's syndrome , migraine , and Alzheimer 's disease showed benefit for attention . A preliminary trial in ADHD using L-carnitine reported significant benefit . METHOD A multi-site 16-week pilot study r and omized 112 children ( 83 boys , 29 girls ) age 5 - 12 with systematic ally diagnosed ADHD to placebo or ALC in weight-based doses from 500 to 1500 mg b.i.d . The 2001 revisions of the Conners ' parent and teacher scales ( including DSM-IV ADHD symptoms ) were administered at baseline , 8 , 12 , and 16 weeks . Analyses were ANOVA of change from baseline to 16 weeks with treatment , center , and treatment-by-center interaction as independent variables . RESULTS The primary intent-to-treat analysis , of 9 DSM-IV teacher-rated inattentive symptoms , was not significant . However , secondary analyses were interesting . There was significant ( p = 0.02 ) moderation by subtype : superiority of ALC over placebo in the inattentive type , with an opposite tendency in combined type . There was also a geographic effect ( p = 0.047 ) . Side effects were negligible ; electrocardiograms , lab work , and physical exam unremarkable . CONCLUSION ALC appears safe , but with no effect on the overall ADHD population ( especially combined type ) . It deserves further exploration for possible benefit specifically in the inattentive type Hyperactivity is a significant problem for almost all young males affected by fragile X syndrome ( FXS ) , the most common inherited disease causing mental retardation . Therapeutical approaches are actually based on Central Nervous System ( CNS ) stimulants lacking a well defined rationale and efficacy while they further decrease the patient 's limited attention span . A pilot study on 17 fragile X male treated with L-acetylcarnitine ( LAC ) over one year , showed a significant reduction of their hyperactivity behaviour tested by the Conners Abbreviated Parent-Teacher Question naire . LAC use in FXS patients derives from the hypothesis that the biochemical and physiological properties this substance has may preserve brain activity . LAC is a small , hydrosoluble molecule that easily diffuses in the extracellular space and enters any cell in the nervous system through specific transporters . Different cerebral areas use this molecule differently to metabolize glucose and lipids to provide for ATP and neurotrasmitters synthesis . The acetyl group LAC carriers represents a key metabolic signaling element possibly mediating its effect in the CNS . The exogenous administration of LAC may affect brain activity in FXS by : I ) modulation of fuel partitioning for energy production , which at the mithocondrial level is associated with the Kreb 's cycle metabolic role in neurotransmitter synthesis ; II ) remodelling of lipid membrane in terms of LAC actively determining the production of polyunsaturated fatty acids ; III ) preferential effect on the attention component of the cholinergic system which relies on its peculiar modality of communication in the CNS . Based on the above premises an explorative , double-blind , placebo controlled , multicenter study is ongoing . A total population of 160 children from nine European centers will be enrolled . The objective of this study is to determine the effect of LAC on the hyperactive behaviour of FXS children as evaluated by the administration of the Conners Abbreviated Parent Question naire To determine safety and the efficacy of carnitine treatment in children with attention-deficit hyperactivity disorder ( ADHD ) . The ADHD behavior was observed by parents completing the Child Behavior Checklist ( CBCL ) and by teachers completing the Conners teacher-rating score , in a r and omized , double-blind , placebo-controlled double-crossover trial . In 13/24 boys receiving carnitine , home behavior improved as assessed with the CBCL total score ( P < 0.02 ) . In 13/24 boys , school behavior improved as assessed with the Conners teacher-rating score ( P < 0.05 ) . Before treatment , the CBCL total and sub-scores were significantly different from those of normal Dutch boys ( P < 0.0001 ) . Responders showed a significant improvement of the CBCL total scores compared to baseline ( P < 0.0001 ) . In the majority of boys no side effects were seen . At baseline and after carnitine treatment , responders showed higher levels of plasma-free carnitine ( P < 0.03 ) and acetylcarnitine ( P < 0.05 ) . Compared to baseline , the carnitine treatment caused in the responsive patients a decrease of 20 - 65 % ( 8 - 48 points ) as assessed by the CBCL total problem rating scale . Treatment with carnitine significantly decreased the attention problems and aggressive behavior in boys with ADHD Fibromyalgia is a chronic condition characterized by widespread pain , fatigue , non-restorative sleep and cognitive difficulties that affects 2 - 4 % of the general population . Recently a possible relationship between the FMR1 premutation and fibromyalgia has been pointed out . In attempt to gather more data we screened for the FMR1 CGG expansion 700 DNA sample s from unrelated fibromyalgia patients . This data might be useful for evaluating the incorporation of this test in rheumatologic procedures for women with fibromyalgia . The observed frequency of FMR1 premutation carriers ( 3 of 700 , 0.4 % ) is not significantly different from the estimated rate in the general female population ( 1/250 - 1/400 ) ( P=0.539 , P=0.716 ) . Clinical exam OUTPUT:

Regarding the primary outcome of psychological and learning capabilities , both studies assessed the effect of interventions on children 's verbal and non-verbal intellectual functioning using the Wechsler Intelligence Scale for Children - Revised . AUTHORS ' CONCLUSIONS Low- quality evidence from two small trials showed that when compared to placebo , LAC may not improve intellectual functioning or hyperactive behaviour in children with FXS

MS2_dynamic_1_shot50

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This multicentre r and omized clinical trial studied how symptoms improved after either stapled anopexy or diathermy excision of haemorrhoids Background The literature indicates higher recurrence rates for stapled hemorrhoidopexy than for conventional techniques . This could be due to inappropriate patient selection . Objective The aim of this study was to evaluate the short- and long-term outcome after stapled hemorrhoidopexy compared with the Milligan – Morgan procedure in a homogeneous patient population with circumferential third-degree hemorrhoids . Design and Patients One hundred thirty patients were enrolled into a r and omized controlled study , of which 122 were clinical ly evaluated at weeks 1 , 2 , and 4 , and thereafter each year for a minimum of 3 years . Patients completed a question naire for symptoms , function , and pain . Pain was assessed using a visual analog scale . Recurrences were determined by anoscopy and self-report . Setting sThe study was performed at the University Hospital Hamburg . Main Outcome Measures Endpoints were pain , recurrence , bleeding , itching/burning , urinary retention , incontinence symptoms , and prolonged rate of wound healing . Results The cumulative recurrence rates after 5 years were 18 % ( n = 11 ) in the stapled hemorrhoidopexy group and 23 % ( n = 14 ) in the Milligan – Morgan group ( p = 0.65 ) . Patients who underwent stapled hemorrhoidopexy had significantly less postoperative pain with mean VAS scores at week 1 : 3.1 vs. 6.2 ; week 2 : 0.5 vs. 3 ; week 4 : 0.05 vs. 0.6 ( p < 0.001 ) , and demonstrated less burning/itching sensation 4 weeks after surgery compared with the Milligan – Morgan group ( 4.9 vs. 19.7 % ; p < 0.001 ) . The postoperative bleeding rate was 4.9 % in both groups and the rate of urinary retention did not differ significantly ( 4.9 % vs. 1.6 % ; p = 0.309 ) . Postoperative incontinence symptoms ( 6.6 % versus 3.3 % ; p = 0.40 ) resolved within the first 6 months . Limitations Detailed measurement of incontinence was not possible because postoperative symptoms resolved between consultations , and pathological results were examined retrospectively . Conclusions The results show a similar rate of recurrence in the long term and suggest increased patient comfort in the early postoperative course after stapled hemorrhoidopexy . In patients with circumferential third-degree hemorrhoids , stapled hemorrhoidopexy is as effective as the Milligan – Morgan procedure Background Milligan-Morgan excision haem-orrhoidectomy remains a very popular treatment modality for third and fourth degree haemorrhoids due to its cost effectiveness and good long-term results . The LigaSure tissue-sealing device is an alternative technique used in haemorrhoidectomy that has been shown to produce favourable results . The aim of this study was to assess the effectiveness of the LigaSure tissue sealing device in comparison with conventional diathermy haemorrhoidectomy Methods A prospect i ve clinical trial was conducted . Patients with newly diagnosed haemorrhoids requiring haemorrhoidectomy were r and omized to either LigaSure haemorrhoidectomy or diathermy haemorrhoidectomy . Surgical technique and postoperative care was st and ardized . Outcome measures were operative time and bleeding , postoperative pain ( measured on a visual analogue scale ) and rate of wound healing Results We r and omized 44 patients , 22 to LigaSure and 22 to diathermy ; 43 patients were evaluated . They were aged between 19 and 71 years . There were no differences in patient demographics or type of haemorrhoid being operated on . LigaSure haemorrhoidectomy had a significantly lower mean operative time and intraoperative bleeding . At 3 weeks after surgery , haemorrhoidectomy performed with LigaSure had an odds ratio for complete epithelialization of 3.1 over diathermy ( 95 % CI 1.2–8.2 ) . There was no difference in postoperative pain Conclusion LigaSure haemorrhoidectomy is superior to diathermy for open PURPOSE It has been shown that for hemorrhoidal surgery both LigaSure ™ and stapler cause less pain than diathermy or scissor dissection . This study has attempted to establish which of the less painful alternatives proves best in an unselected series of patients with hemorrhoidal disease . METHODS Fifty patients were r and omized to undergo stapling hemorrhoidopexy or LigaSure ™ hemorrhoidectomy . Parameters investigated were pain ( primary parameter ) , patient satisfaction with treatment , and recovery of personal activity . Other factors investigated were operative result , ease of h and ling , analgesic requirements , and postoperative course . RESULTS Both methods were found to be equivalent in all major aspects analyzed . Postoperative pain scores ( P = 0.99 ) , patient satisfaction ( P = 1 ) , and self- assessment of activity ( P = 0.99 ) were almost identical in both groups of patients . Significant differences were found in none of the numerous factors investigated . CONCLUSION Both methods can be used safely and without major disadvantage for the patient regardless of stage and extent of hemorrhoidal disease Background and aims Stapled hemorrhoidectomy is a relatively new procedure , and studies on long-term outcomes are few . We present the results of a 5-year follow-up on patients recruited to a r and omized controlled trial comparing stapled and Milligan – Morgan hemorrhoidectomy . Patients and methods We performed telephone interviews and office visits between May and July 2005 on patients who had taken part in a r and omized controlled trial from May 1999 to December 2000 . Results Occasional pain and bleeding were referred by the patients with no difference between the two groups . The patients were also equally satisfied OUTPUT: After stapled , LigaSure ™ and Harmonic ® haemorrhoidectomies patients resumed normal daily activities earlier than after open and closed procedures . THD provided the earliest time to first bowel movement . The stapled and THD groups had significantly higher haemorrhoid recurrence rates than the open , closed and LigaSure ™ groups . Recurrence of haemorrhoidal symptoms was more common after stapled haemorrhoidectomy than after open and LigaSure ™ operations . No significant difference was identified between treatments for anal stenosis , incontinence and perianal skin tags . CONCLUSION Open and closed haemorrhoidectomies result ed in more postoperative complications and slower recovery , but fewer haemorrhoid recurrences . THD and stapled haemorrhoidectomies were associated with decreased postoperative pain and faster recovery , but higher recurrence rates . INPUT: Abstract Background The aim of the study was to compare ligation anopexy ( LA ) and conventional hemorrhoidectomy ( CH ) in treatment of second- and third-degree hemorrhoids . Methods A prospect i ve controlled r and omized clinical trial included 100 patients who underwent CH ( CH group ) and 100 patients who underwent LA ( LA group ) . A detailed history was taken from all the patients . The effectiveness , safety , postoperative complications , operative time , length of hospital stay , time until first bowel movement , time until return to work , and postoperative pain score were assessed . Results There was no significant difference between groups regarding age , sex , and preoperative symptoms . The LA group had significantly shorter operative times , earlier first bowel movement , and an earlier return to work/activities . The postoperative pain score in the LA group was significantly lower than that in the CH group on days 1 , 3 , 7 , and 14 after surgery . There was no significant difference between groups as regards postoperative complications . Conclusions LA is safe , and as effective as CH in the treatment of grade II and grade III hemorrhoids , with shorter operative times , earlier mobilization , and lower postoperative pain scores The CONSORT ( Consoli date d St and ards of Reporting Trials ) Statement aims to improve the reporting of r and omized controlled trials ( RCTs ) ; however , it lacks guidance on the reporting of patient-reported outcomes ( PROs ) , which are often inadequately reported in trials , thus limiting the value of these data . In this article , we describe the development of the CONSORT PRO extension based on the method ological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research ( EQUATOR ) Network . Five CONSORT PRO checklist items are recommended for RCTs in which PROs are primary or important secondary end points . These recommendations urge that the PROs be identified as a primary or secondary outcome in the abstract , that a description of the hypothesis of the PROs and relevant domains be provided ( ie , if a multidimensional PRO tool has been used ) , that evidence of the PRO instrument 's validity and reliability be provided or cited , that the statistical approaches for dealing with missing data be explicitly stated , and that PRO-specific limitations of study findings and generalizability of results to other population s and clinical practice be discussed . Examples and an up date d CONSORT flow diagram with PRO items are provided . It is recommended that the CONSORT PRO guidance supplement the st and ard CONSORT guidelines for reporting RCTs with PROs as primary or secondary outcomes . Improved reporting of PRO data should facilitate robust interpretation of the results from RCTs and inform patient care This multicentre r and omized clinical trial studied how symptoms improved after either stapled anopexy or diathermy excision of haemorrhoids AIM The study aim ed in a multicentric r and omized controlled trial to define the role of a more extensive mucosal resection on recurrence of mucosal prolapse in patients with Stage III haemorrhoids undergoing stapled haemorrhoidopexy . METHOD In all , 135 patients were r and omized to treatment with a PPH-01/03 ( Ethicon EndoSurgery ) or an EEA ( Covidien ) stapler . They were review ed after a minimum follow-up of 4 years to determine the rate of recurrent mucosal prolapse and general condition ( wellness evaluation score ) . Postoperative bowel dysfunction was assessed using the Rome III criteria . RESULTS Eighty-seven ( 65 % ) of the 135 patients ( 48 in the EEA stapler group and 37 in the PPH group ) were available for long-term follow-up . The two groups were comparable for age , gender and duration of follow-up ( mean 49.3 ± 5.4 months and 49.0 ± 5.3 months respectively ) . In the EEA group , 11 ( 23 % ) patients had some degree of recurrent prolapse compared with 12 ( 32 % ) in the PPH group ( P = 0.409 ) . Persistence of anal bleeding was significantly higher in the PPH group ( P = 0.04 ) while the postoperative Haemorrhoid Symptom Score was significantly better in the EEA group ( 1.73 ± 1.65 vs 3.17 ± 1.94 , P < 0.001 ) . The wellness evaluation score was significantly better in the EEA group ( 1.2 ± 1.27 vs 0.6 ± 1.0 , P = 0.028 ) . Furthermore , 7 ( 15 % ) of the patients in the EEA group complained of some evacuation disturbance compared with 13 ( 36 % ) in the PPH group ( P = 0.021 ) . CONCLUSION The study failed to demonstrate any significant difference in the long-term recurrence rate of Stage III haemorrhoids using EEA or PPH . Nevertheless , use of the larger volume EEA provides better symptom resolution compared with PPH Objective : Unlike excisional haemorrhoidectomy , stapled anopexy ( SA ) , which does not involve radical excision , has theoretical advantages , thus offering potential patient benefits . We compared the clinical efficacy , safety and patient acceptability of SA , with closed haemorrhoidectomy ( CH ) . Patients and methods : 182 patients with symptomatic haemorrhoids ( grade s II , III , IV ) were r and omly assigned to receive SA or CH and were followed for up to 1 year ( 6 , 12 , 24 , 48 weeks ) after operation . Postoperative pain , symptom control , complications , re-treatment rates , patient satisfaction , and quality of life were compared on an intention-to-treat basis . Results : Postoperative pain in the SA group ( n = 91 ) was significantly lower ( p = 0.004 , Mann – Whitney U test ) . At 1 year there were no significant differences in the symptom load , symptom severity or the disease severity between the two groups . Overall complication rates were similar OUTPUT:

Scores values tended to decrease postoperatively .

MS2_dynamic_1_shot51

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background : The prevalence of type 2 diabetes and diabetesrelated morbidity and mortality is higher among low-income Hispanics when compared to that of Whites . However , little is known about how to effectively promote self-management in this population . Purpose : The objectives were first to determine the feasibility of conducting a r and omized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects . Methods : Participants for this pilot study were recruited from a community health center , an elder program , and a community-wide data base developed by the community health center , in collaboration with other agencies serving the community , by surveying households in the entire community . Participants were r and omly assigned to an intervention ( n = 15 ) or a control ( n = 10 ) condition . Assessment s were conducted at baseline and at 3 months and 6 months postr and omization . The intervention consisted of 10 group sessions that targeted diabetes knowledge , attitudes , and self-management skills through culturally specific and literacysensitive strategies . The intervention used a cognitivebehavioral theoretical framework . Results : Recruitment rates at the community health center , elder program , and community registry were 48 % , 69 % , and 8 % , respectively . Completion rates for baseline , 3-month , and 6-month assessment s were 100 % , 92 % , and 92 % , respectively . Each intervention participant attended an average of 7.8 out of 10 sessions , and as a group the participants showed high adherence to intervention activities ( 93 % turned in daily logs , and 80 % self-monitored glucose levels at least daily ) . There was an overall Group × Time interaction ( p = .02 ) indicating group differences in glycosylated hemoglobin over time . The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was −0.8 % ( 95 % confidence intervals = −1.1 % , −0.5 % ) compared with the change in the control group ( p = .02 ) . At 6 months , the decrease in the intervention group remained significant , −0.85 % ( 95 % confidence intervals = −1.2 , −0.5 ) , and the decrease was still significantly different from that of the controls ( p = .005 ) . There was a trend toward increased physical activity in the intervention group as compared to that of the control group ( p = .11 ) and some evidence ( nonsignificant ) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants . Adjusting for baseline depressive scores , we oberved a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment ( p = .02 ) . Conclusions : Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research . This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a r and omized clinical trial BACKGROUND Patients with depression and poorly controlled diabetes , coronary heart disease , or both have an increased risk of adverse outcomes and high health care costs . We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients . METHODS We conducted a single-blind , r and omized , controlled trial in 14 primary care clinics in an integrated health care system in Washington State , involving 214 participants with poorly controlled diabetes , coronary heart disease , or both and coexisting depression . Patients were r and omly assigned to the usual-care group or to the intervention group , in which a medically supervised nurse , working with each patient 's primary care physician , provided guideline -based , collaborative care management , with the goal of controlling risk factors associated with multiple diseases . The primary outcome was based on simultaneous modeling of glycated hemoglobin , low-density lipoprotein ( LDL ) cholesterol , and systolic blood-pressure levels and Symptom Checklist-20 ( SCL-20 ) depression outcomes at 12 months ; this modeling allowed estimation of a single overall treatment effect . RESULTS As compared with controls , patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels ( difference , 0.58 % ) , LDL cholesterol levels ( difference , 6.9 mg per deciliter [ 0.2 mmol per liter ] ) , systolic blood pressure ( difference , 5.1 mm Hg ) , and SCL-20 depression scores ( difference , 0.40 points ) ( P<0.001 ) . Patients in the intervention group also were more likely to have one or more adjustments of insulin ( P=0.006 ) , antihypertensive medications ( P<0.001 ) , and antidepressant medications ( P<0.001 ) , and they had better quality of life ( P<0.001 ) and greater satisfaction with care for diabetes , coronary heart disease , or both ( P<0.001 ) and with care for depression ( P<0.001 ) . CONCLUSIONS As compared with usual care , an intervention involving nurses who provided guideline -based , patient-centered management of depression and chronic disease significantly improved control of medical disease and depression . ( Funded by the National Institute of Mental Health ; Clinical Trials.gov number , NCT00468676 . ) BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual OUTPUT: Conclusion Depression was associated with lower adherence to diabetes self-care , as evidence d primarily by descriptive studies ; results of intervention studies were conflicting . INPUT: OBJECTIVE To evaluate associations between psychosocial and social-environmental variables and diabetes self-management , and diabetes control . RESEARCH DESIGN AND METHODS Baseline data from a type 2 diabetes self-management r and omized trial with 463 adults having elevated BMI ( M = 34.8 kg/m2 ) were used to investigate relations among demographic , psychosocial , and social-environmental variables ; dietary , exercise , and medication-taking behaviors ; and biologic outcomes . RESULTS Self-efficacy , problem solving , and social-environmental support were independently associated with diet and exercise , increasing the variance accounted for by 23 and 19 % , respectively . Only diet contributed to explained variance in BMI ( β = −0.17 , P = 0.0003 ) and self-rated health status ( β = 0.25 , P < 0.0001 ) ; and only medication-taking behaviors contributed to lipid ratio ( total – to – HDL ) ( β = −0.20 , P = 0.0001 ) and A1C ( β = −0.21 , P < 0.0001 ) . CONCLUSIONS Interventions should focus on enhancing self-efficacy , problem solving , and social-environmental support to improve self-management of diabetes OBJECTIVE This study examined the impact of a 6-month , empowerment-based diabetes self-management support ( DSMS ) intervention on clinical outcomes , self-care behaviors , and quality of life ( QOL ) compared to a 6-month control period . METHODS This control-intervention cohort study recruited 77 African-American adults with type 2 diabetes . Baseline , 6-month , and 12-month assessment s measured A1C , weight , body mass index ( BMI ) , blood pressure , lipids , self-care behaviors , and QOL . During the control period , participants received weekly educational newsletters . During the intervention period , participants attended weekly DSMS groups as frequently as they needed . Sessions were guided by participants ' self-management questions and concerns , and also emphasized experiential learning , coping , problem-solving , and goal - setting . RESULTS The control period found significant improvements for diastolic BP ( p<0.05 ) , serum cholesterol ( p<0.001 ) , following a healthy diet ( p<0.01 ) , and monitoring blood glucose ( p<0.01 ) . The intervention period found significant additional improvements for A1C ( p<0.001 ) , weight ( p<0.05 ) , BMI ( p<0.05 ) , and LDL ( p<0.001 ) . Compared to the control period , participation in the intervention led to a significant reduction in A1C ( p<0.01 ) . CONCLUSION Findings suggest that an empowerment-based , DSMS intervention is promising for improving and /or maintaining diabetes-related health , particularly A1C . PRACTICAL IMPLICATION S Incorporating empowerment principles in DSMS interventions may be useful for supporting patients ' self-management efforts in " real-world " setting OBJECTIVE To conduct a 1-year r and omized clinical trial to evaluate a remote comprehensive diabetes self-management education ( DSME ) intervention , Diabetes TeleCare , administered by a dietitian and nurse/certified diabetes educator ( CDE ) in the setting of a federally qualified health center ( FQHC ) in rural South Carolina . RESEARCH DESIGN AND METHODS Participants were recruited from three member health centers of an FQHC and were r and omized to either Diabetes TeleCare , a 12-month , 13-session curriculum delivered using telehealth strategies , or usual care . RESULTS Mixed linear regression model results for repeated measures showed a significant reduction in glycated hemoglobin ( GHb ) in the Diabetes TeleCare group from baseline to 6 and 12 months ( 9.4 ± 0.3 , 8.3 ± 0.3 , and 8.2 ± 0.4 , respectively ) compared with usual care ( 8.8 ± 0.3 , 8.6 ± 0.3 , and 8.6 ± 0.3 , respectively ) . LDL cholesterol was reduced at 12 months in the Diabetes TeleCare group compared with usual care . Although not part of the original study design , GHb was reduced from baseline to 12 and 24 months in the Diabetes TeleCare group ( 9.2 ± 0.4 , 7.4 ± 0.5 , and 7.6 ± 0.5 , respectively ) compared with usual care ( 8.7 ± 0.4 , 8.1 ± 0.4 , and 8.1 ± 0.5 , respectively ) in a post hoc analysis of a subset of the r and omized sample who completed a 24-month follow-up visit . CONCLUSIONS Telehealth effectively created access to successfully conduct a 1-year remote DSME by a nurse CDE and dietitian that improved metabolic control and reduced cardiovascular risk in an ethnically diverse and rural population This article describes the design and implementation of an online diabetes self-management intervention for a sample of inner-city African Americans with diabetes . Study participants were r and omly assigned to the treatment ( 26 ) and control ( 21 ) conditions . The results indicate that treatment group participants were more likely to achieve positive outcomes in terms of lowered hemoglobin A1c and body mass index measurements than were control group members . These findings support the development of telehealth interventions to promote effective chronic disease management in medically underserved communities OBJECTIVE The Informatics for Diabetes Education and Telemedicine ( IDEATel ) project r and omized ethnically diverse underserved older adults with diabetes to a telemedicine intervention or usual care . OUTPUT:

Characteristics of successful interventions included using problem solving with the patient , culturally tailoring the intervention , and using a nurse educator .

MS2_dynamic_1_shot52

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Obstructive sleep apnea syndrome ( OSAS ) has been associated with increased morbidity and mortality , principally from cardiovascular disease , but the impact of nasal continuous positive airway pressure ( CPAP ) therapy is unclear . METHODS We performed a long-term follow-up study of 168 patients with OSAS who had begun receiving CPAP therapy at least 5 years previously , most of whom had been prospect ively followed up , having been the subject of an earlier report on cardiovascular risk factors in OSAS patients . The average follow-up period was 7.5 years . We compared the cardiovascular outcomes of those patients who were intolerant of CPAP ( untreated group , 61 patients ) with those continuing CPAP therapy ( 107 patients ) . RESULTS CPAP-treated patients had a higher median apnea-hypopnea index score than the untreated group ( 48.3 [ interquartile range ( IQR ) , 33.6 to 66.4 ] vs 36.7 [ IQR , 27.4 to 55 ] , respectively ; p = 0.02 ) , but age , body mass index , and time since diagnosis were similar . Deaths from cardiovascular disease were more common in the untreated group than in the CPAP-treated group during follow-up ( 14.8 % vs 1.9 % , respectively ; p = 0.009 [ log rank test ] ) , but no significant differences were found in the development of new cases of hypertension , cardiac disorder , or stroke . Total cardiovascular events ( ie , death and new cardiovascular disease combined ) were more common in the untreated group than in the CPAP-treated group ( 31 % vs 18 % , respectively ; p < 0.05 ) . CONCLUSIONS The data support a protective effect of CPAP therapy against death from cardiovascular disease in patients with OSAS STUDY OBJECTIVES A high incidence of nocturnal cardiac rhythm disturbances among patients with obstructive sleep apnea ( OSA ) syndrome has been described in some reports , but not in others . We wished to examine the prevalence of significant cardiac rhythm disturbance in patients with established moderate to severe OSA syndrome and , in particular , to assess the impact of nasal continuous positive airway pressure ( nCPAP ) therapy . DESIGN AND SETTING A prospect i ve study of consecutive eligible patients in a dedicated sleep disorders unit of a university teaching hospital . MEASUREMENTS AND RESULTS Holter monitoring was performed for 18 h in 45 patients with previously diagnosed OSA syndrome ( mean [ SD ] apnea/hypopnea frequency [ AHI ] of 50 [23]/h ) and repeated within 2 to 3 days after institution of nCPAP therapy . Investigators were blinded to the patients ' treatments during data analysis . Thirty-five patients were found to have some cardiac rhythm disturbance , but only 8 had pathologically significant disturbances ( ventricular tachycardia or fibrillation , complex ventricular ectopy , new-onset supraventricular tachycardia other than sinus tachycardia , pauses of > 2 s , and second- or third-degree heart block ) . Significant rhythm disturbances occurred only during the nighttime , and there was a significant correlation between OSA severity and the severity of rhythm disturbance ( p = 0.04 , r = 0.301 ) . No significant correlation was found between OSA severity and any other anthropometric parameter measured . nCPAP therapy result ed in abolition of rhythm disturbance in seven of these eight patients ; the eighth patient was found to have coexisting severe aortic valve disease requiring valve replacement . CONCLUSION The data indicate that OSA syndrome predisposes to clinical ly significant cardiac rhythm disturbances that can be successfully controlled by nCPAP therapy The prevalence and clinical significance of sleep-related breathing disorders ( SRBDs ) in patients with cardiac disease and a history of life-threatening ventricular tachyarrhythmias is unclear . Forty consecutive recipients of implantable cardioverter defibrillators ( ICDs ) with cardiac disease and a documented history of spontaneous , life-threatening , ventricular tachyarrhythmias underwent full night polysomnography . SRBDs were diagnosed if the apnea/hypopnea index was > 10 . SRBD were diagnosed in 16 of 40 patients ( 40 % ) : central sleep apnea ( CSA ) was present in 9 of these 16 patients ( 56 % ) , 8 of whom had associated Cheyne-Stoke respiration . Seven of the 16 patients with SRBD ( 44 % ) had obstructive sleep apnea ( OSA ) . Patients with and without SRBDs were comparable with respect to left ventricular ejection fraction , NYHA classification , underlying heart disease , ICD indications , and concomitant antiarrhythmic drug and beta-blocker therapy . Patients were followed prospect ively for 2 years . ICD-treated ventricular tachyarrhythmias occurred in 10 of 24 patients ( 42 % ) without SRBD , in 4 of 9 patients ( 44 % ) with CSA , and in 3 of 7 patients ( 44 % ) with OSA ( NS ) . The numbers and circadian distributions of episodes recorded during follow-up in patients without SRBD versus with CSA or OSA were not significantly different ( 14 + /- 25 , median = 4 vs 4 + /- 5 , median = 2.5 vs 15 + /- 15 , median = 7 , respectively ) . The 2-year mortality , which was entirely attributable to nonsudden cardiac events , was highest in patients with CSA ( 4/9 [ 44 % ] , vs 0/7 [ 0 % ] with OSA , vs 3/24 patients ( 12.5 % ) without SRBD ; P < 0.05 ) OUTPUT: Patients with OSA were noted to have higher odds of ventricular ectopy , and were at a higher risk for ventricular arrhythmias . Associations included higher QTc dispersion and HR variability . We did not , however , find any clear evidence for a direct correlation between increased apnea hypopnea index and increased VT or VF . In a systemic review of studies , patients with OSA were noted to have higher odds of ventricular ectopy and arrhythmias . A single study showed that CPAP may help lower arrhythmogenicity ; however , it was unclear if CPAP lowered the risk of VT . INPUT: OBJECTIVES Complaints of fatigue are frequent in patients with obstructive sleep apnea ( OSA ) ; however , the impact of continuous positive airway pressure ( CPAP ) on fatigue remains unclear . METHODS Fifty-nine men and women with OSA were r and omly assigned to therapeutic or placebo CPAP in a double-blind fashion for a 3-week intervention period . Four outcome measures were assessed : ( 1 ) fatigue/vigor measured with the Multidimensional Fatigue Symptom Inventory -- Short Form ( MFSI-sf ) , the ( 2 ) fatigue and ( 3 ) vigor subscales of the Profile of Mood States -- Short Form ( POMS ) , and ( 4 ) the Epworth Sleepiness Scale ( ESS ) . Data were analyzed using repeated- measures analysis of variance . RESULTS Compared with patients receiving placebo CPAP , those patients treated with therapeutic CPAP showed significant reductions in the apnea-hypopnea index , as well as decreases in both measures of fatigue and increases in vigor ( P values < 0.05 ) . The beneficial effect of therapeutic treatment was most pronounced in patients with high levels of fatigue at study onset . Significant treatment effects in sleepiness scores were not observed in the entire sample ( P > 0.05 ) ; however , in a subset of patients with excessive sleepiness at the onset of treatment , ESS scores were significantly reduced with use of therapeutic CPAP ( P < 0.05 ) . CONCLUSIONS Results suggest that 3 weeks of therapeutic CPAP significantly reduced fatigue and increased energy in patients with OSA . Therapeutic CPAP significantly reduced daytime sleepiness in patients who reported excessive sleepiness at the onset of treatment BACKGROUND Cognitive complaints are reported frequently after breast cancer treatments . Their association with neuropsychological ( NP ) test performance is not well-established . METHODS Early-stage , posttreatment breast cancer patients were enrolled in a prospect i ve , longitudinal , cohort study prior to starting endocrine therapy . Evaluation included an NP test battery and self-report question naires assessing symptoms , including cognitive complaints . Multivariable regression models assessed associations among cognitive complaints , mood , treatment exposures , and NP test performance . RESULTS One hundred eighty-nine breast cancer patients , aged 21 - 65 years , completed the evaluation ; 23.3 % endorsed higher memory complaints and 19.0 % reported higher executive function complaints ( > 1 SD above the mean for healthy control sample ) . Regression modeling demonstrated a statistically significant association of higher memory complaints with combined chemotherapy and radiation treatments ( P = .01 ) , poorer NP verbal memory performance ( P = .02 ) , and higher depressive symptoms ( P < .001 ) , controlling for age and IQ . For executive functioning complaints , multivariable modeling controlling for age , IQ , and other confounds demonstrated statistically significant associations with better NP visual memory performance ( P = .03 ) and higher depressive symptoms ( P < .001 ) , whereas combined chemotherapy and radiation treatment ( P = .05 ) approached statistical significance . CONCLUSIONS About one in five post-adjuvant treatment breast cancer patients had elevated memory and /or executive function complaints that were statistically significantly associated with domain-specific NP test performances and depressive symptoms ; combined chemotherapy and radiation treatment was also statistically significantly associated with memory complaints . These results and other emerging studies suggest that subjective cognitive complaints in part reflect objective NP performance , although their etiology and biology appear to be multifactorial , motivating further transdisciplinary research This investigation evaluates two common measures of cancer-related fatigue , one multidimensional/retrospective and one unidimensional/same day . Fifty-two African American survivors of diverse cancers completed fatigue visual analogue scales once daily , and the Multidimensional Fatigue Symptom Inventory-Short Form ( MFSI-SF ) once weekly , for four weeks . Zero-order correlations showed retrospective fatigue was significantly related to average , peak , and most recent same-day fatigue . Multilevel r and om coefficient modeling showed unidimensional fatigue shared the most variance with the MFSI-SF 's General subscale for three weeks , and with the Vigor subscale for one week . Research ers and clinicians may wish to prioritize multidimensional measures when assessing cancer-related fatigue , if appropriate OBJECTIVE Insomnia is frequently comorbid with other medical and psychological disorders . This secondary data analysis investigated whether an Internet-delivered cognitive behavioral therapy for insomnia ( CBT-I ) intervention could also reduce comorbid psychological and fatigue symptoms . METHOD Data from a pilot r and omized controlled trial ( RCT ) testing the efficacy of Internet-delivered CBT-I relative to a waitlist control was used to examine changes in symptoms of depression , anxiety , mental health quality of life ( QOL ) , and fatigue . RESULTS Group by time interactions from repeated measures analyses revealed significant post intervention improvements in Internet participants ( n = 22 ) relative to control participants ( n = 22 ) on all psychological symptoms , mental health QOL , and fatigue . A small post hoc sub sample of Internet participants with mild or moderate depression also showed large effect size changes in these constructs ( depression , anxiety , mental health QOL , and fatigue ) . CONCLUSION Internet-delivered CBT-I appears to not only improve sleep but also reduce comorbid psychological and fatigue symptoms Women with breast cancer are one of the largest groups of cancer survivors . This research examined whether breast cancer has a long-term impact on quality of life ( QOL ) by comparing 5-year disease-free survivors to age-matched controls and by comparing women who sustained a recurrence to disease-free survivors . Controls were recruited using the neighborhood control methodology . QOL ( physical , emotional , social , and spiritual ) was assessed during in-person interviews . There were no differences between disease-free survivors ( n = 267 ) and controls ( OUTPUT:

The MFSI-SF demonstrated moderate test-retest reliability in a small number of studies . The MFSI-SF fatigue subscales were positively correlated with measures of distress , depressive , and anxious symptoms .

MS2_dynamic_1_shot53

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background and Purpose — High rates of ischemic stroke and poor adherence to secondary prevention measures are observed in the Chinese population . Methods — We used a national , multicenter , cluster-r and omized controlled trial in which 47 hospitals were r and omized to either a structured care program group ( n=23 ) or a usual care group ( n=24 ) . The structured care program consisted of a specialist-administered , guideline -recommended pharmaceutical treatment and a lifestyle modification algorithm associated with written and Internet-accessed educational material for patients for the secondary prevention of ischemic stroke . The primary efficacy outcome was the proportion of patients who adhered to the recommended measures at 12-month postdischarge . This trial is registered with Clinical Trial.gov ( NCT00664846 ) . Results — At 12 months , 1287 ( 72.1 % ) patients in the St and ard Medical Management in Secondary Prevention of Ischemic Stroke in China ( SMART ) group and 1430 ( 72 % ) patients in the usual care group had completed the 12-month follow-up ( P=0.342 ) . Compared with the usual care group , those in the SMART group showed higher adherence to statins ( 56 % versus 33 % ; P=0.006 ) but no difference in adherence to antiplatelet ( 81 % versus 75 % ; P=0.088 ) , antihypertensive ( 67 % versus 69 % ; P=0.661 ) , or diabetes mellitus drugs ( 73 % versus 67 % ; P=0.297 ) . No significant difference in the composite end point ( new-onset ischemic stroke , hemorrhagic stroke , acute coronary syndrome , and all-cause death ) was observed ( 3.56 % versus 3.59 % ; P=0.921 ) . Conclusions — The implementation of a program to improve adherence to secondary ischemic stroke prevention efforts in China is feasible , but these programs had only a limited impact on adherence and no impact on 1-year outcomes . Further development of a structured program to reduce vascular events after stroke is needed . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00664846 Background Community-based health education programs may be helpful in improving health outcomes in patients with chronic illnesses . This study aim ed to evaluate community-based health education strategies in the management of hypertensive patients with low socioeconomic status in Dongguan City , China . Methods This was a r and omized , non-blinded trial involving 360 hypertensive patients enrolled in the community health service centre of Liaobu Town , Dongguan City , China . Participants were r and omized to receive one of the three community-based health education programs over 2 years : self-learning reading ( Group 1 ) , monthly regular didactic lecture ( Group 2 ) , monthly interactive education workshop ( Group 3 ) . Outcomes included the changes in the proportion of subjects with normalized blood pressure ( BP ) , hypertension-related knowledge score , adherence to antihypertensive treatment , lifestyle , body mass index and serum lipids . Results After the 2-y intervention , the proportion of subjects with normalized BP increased significantly in Group 2 ( from 41.2 % to 63.2 % , p<0.001 ) , and increased more substantially in Group 3 ( from 40.2 % to 86.3 % , p<0.001 ) , but did not change significantly in Group 1 . Improvements in hypertension-related knowledge score , adherence to regular use of medications , appropriate salt intake and regular physical activity were progressively greater from group 1 to group 2 to group 3 . Group 3 had the largest reductions in body mass index and serum LDL cholesterol levels . Conclusion Interactive education workshops may be the most effective strategy in community-based health promotion education programs for hypertensive patients in improving patients ’ knowledge on hypertension and alleviating clinical risk factors for preventing hypertension-related complications Limited data are available on epidemiology and drug use in Chinese hypertensive patients with chronic kidney disease ( CKD ) . We determined the prevalence ; awareness , treatment , and control rates of hypertension ; anti-hypertensive use , expenditure pattern ; and factors associated with hypertension prevalence and control in Chinese patients with CKD . This was one of the largest cross-sectional surveys that enrolled 6079 CKD participants ( mean age , 51.0 ± 16.37 years ) with or without hypertension from 22 centres across China . The prevalence , awareness , and treatment rates were 71.2 % , 95.4 % , and 93.7 % , respectively . Control rates 1 and 2 ( Blood pressure , BP < 140/90 and < 130/80 mmHg ) were 41.1 % and 15.0 % , respectively . Patients were treated mostly with monotherapy ( 37.7 % ) or 2-drug anti-hypertensive combination ( 38.7 % ) . Factors associated with prevalence of hypertension included age ; smoking ; body mass index ; physical exercise ; family history of hypertension ; hyperuricaemia ; and CKD . Control rate was associated with CKD stage , BP monitoring at home , and use of drug combinations . Despite high rates of awareness and treatment , the control rates are low . CKD stages 4 and 5 adversely affect the control rate . The results suggest the immediate need of comprehensive controlling measures to improve the control of hypertension in Chinese patients with CKD This study aims to develop a nurse-led hypertension management model in the community setting and pilot it to an experimental trial . A total of 73 recruited participants were r and omly allocated into two groups . The study group received a home visit and 2 - 4 telephone follow-ups from the trained community OUTPUT: Longer duration of intervention gave better effectiveness . Physician as interventionist , regular follow-up visits and interventions conducted at a hospital were associated with better effectiveness . Adherence interventions improve MA and reduce uncontrolled BP among Chinese patients with hypertension . INPUT: Background Enhanced secondary preventive follow-up after stroke or transient ischemic attack ( TIA ) is necessary for improved adherence to recommendations regarding blood pressure ( BP ) and low-density lipoprotein cholesterol ( LDL-C ) levels . We investigated whether nurse-led , telephone-based follow-up was more efficient than usual care at improving BP and LDL-C levels at 12 months after hospital discharge . Methods We r and omized 537 patients to either nurse-led , telephone-based follow-up ( intervention ) or usual care ( control ) . BP and LDL-C measurements were performed at 1 month ( baseline ) and 12 months post-discharge . Intervention group patients who did not meet target values at baseline received additional follow-up , including titration of medication and lifestyle counselling , to reach treatment goals ( BP < 140/90 mmHg , LDL-C < 2.5 mmol/L ) . Results At 12 months , mean systolic BP , diastolic BP and LDL-C was 3.3 ( 95 % CI 0.3 to 6.3 ) mmHg , 2.3 mmHg ( 95 % CI 0.5 to 4.2 ) and 0.3 mmol/L ( 95 % CI 0.1 to 0.4 ) lower in the intervention group compared to controls . Among participants with values above the treatment goal at baseline , the difference in systolic BP and LDL-C was more pronounced ( 8.0 mmHg , 95 % CI 4.0 to 12.1 , and 0.6 mmol/L , 95 % CI 0.4 to 0.9 ) . A larger proportion of the intervention group reached the treatment goal for systolic BP ( 68.5 vs. 56.8 % , p = 0.008 ) and LDL-C ( 69.7 % vs. 50.4 % , p < 0.001 ) . Conclusions Nurse-led , telephone-based secondary preventive follow-up , including medication adjustment , was significantly more efficient than usual care at improving BP and LDL-C levels by 12 months post-discharge . Trial Registration IS RCT N Registry IS RCT BACKGROUND AND PURPOSE Limited evidence exists on the benefits of organized care for improving risk factor control in patients with stroke or transient ischaemic attack . The effectiveness of an individualized management programme in reducing absolute cardiovascular disease risk in this high-risk population was determined . METHODS This was a prospect i ve , multicentre , cluster-r and omized controlled trial with blinded assessment of outcomes and intention-to-treat analysis . Patients hospitalized for stroke/transient ischaemic attack and aged ≥18 years were recruited from four hospitals . General practice s treating recruited patients were r and omized to provide either usual care or an individualized management programme comprising nurse-led education and review of care plans by stroke specialists in addition to usual care . The primary outcome was a change in cardiovascular Framingham Risk Score between baseline and 12 months . RESULTS From January 2010 to November 2013 , 156 general practice s ( 280 patients ) were r and omly assigned to usual care ( control ) and 159 ( 283 patients ) to the intervention . The median age was 70.1 years ; 65 % were male . Overall , > 80 % of participants were prescribed recommended secondary prevention therapies at baseline . The primary efficacy analysis comprised 533 participants , with 30 either dying or lost to follow-up . In adjusted analyses , no significant between-group difference was found in the cardiovascular risk score at 12 months ( 0.04 , 95 % confidence interval -1.7 , 1.8 ) . CONCLUSIONS The effectiveness of an organized secondary prevention programme for stroke may be limited in patients from high-performing hospitals with regular post-discharge follow-up and communication with general practice Nir Z , Zolotogorsky Z , Sugarman H : Structured nursing intervention versus routine rehabilitation after stroke . Am J Phys Med Rehabil 2004;83:522–529 . Objective : The goal of this study was to examine the effect of a structured , comprehensive nursing intervention on the course of rehabilitation over the first 6 mos after a first-ever stroke . Design : Intervention ( experimental ) study . The participants were 155 elderly stroke survivors who were admitted to a geriatric rehabilitation department . Stratified r and om sampling generated intervention and control groups . The intervention was design ed to work together with the routine rehabilitation program and consisted of 12 consecutive weekly meetings . The control group received only the routine rehabilitation program . Study variables were measured at entry to study and after 3- and 6-mo intervals . Results : Although there were no significant differences between the two groups at entry to study , at 3 and 6 mos after stroke , the intervention group showed better scores than the control group in functional status ( FIM ™ instrument ) , depression ( Geriatric Depression Scale ) , self-perceived health , self-esteem , and dietary adherence . Conclusion : The nursing intervention had both short- and long-term effects on functional , psychological , and emotional variables . Serious consideration should be given to implementing comprehensive nursing interventions during rehabilitation tailored to meet the specific needs of stroke survivors and their caregivers The aim was to study if health outcome and secondary prevention were satisfactory 1 year after stroke and if nurse-led interventions 3 months after stroke could have impact . Design was a r and omized controlled open trial in a 1-year population . Primary outcome was health status 1 year after stroke . One month after stroke , survivors were r and omized into intervention group ( IG ) with follow-up by a specialist nurse ( SN ) after 3 months ( n = 232 ) , and OUTPUT:

Conclusion : We found that interventions in which nurses had a primary role were effective on improving medical and behavioral risk factors , as well as knowledge of risk factors as part of secondary prevention of stroke

MS2_dynamic_1_shot54

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: AIM : The seeds of the Nigella sativa plant have been used to promote health and fight disease for centuries , especially in the Middle East and in Southeast Asia . This plant has been a focus of much research . This clinical study was undertaken to know the adjuvant effect of N. sativa oil on various clinical and biochemical parameters of the insulin resistance syndrome . MATERIAL S AND METHODS : This prospect i ve study was conducted at a tertiary health care center in North India . After confirmation of diagnosis , 60 patients who fulfilled the inclusion and exclusion criteria were enrolled in this study . Written informed consent was taken from all the patients enrolled . Approval from the institutional ethical committee was also obtained . The patients were divided into two groups of 30 each . In group I ( the st and ard group ) , patients were advised tablet atorvastatin 10 mg once a day and tablet metformin 500 mg twice a day for a period of 6 weeks . In group II ( the N. sativa group ) , the patients were advised tablet atorvastatin 10 mg once a day , tablet metformin 500 mg twice a day , and N. sativa oil 2.5 ml twice daily for a period of 6 weeks . Fasting and postpr and ial blood glucose , fasting lipid profile , and waist circumference were recorded before therapy and after completion of therapy . RESULT : The treatment group showed significant ( P < 0.05 ) improvement with reference to total cholesterol , low density lipoprotein cholesterol ( LDL-C ) , and fasting blood glucose ( P < 0.05 ) . CONCLUSION : N. sativa oil was found to be effective as an add-on therapy in patients of insulin resistance syndrome . N. sativa oil has a significant activity in diabetic and dyslipidemic patients Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P < 0.05–0.01 ) . Meanwhile , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P < 0.01 ) when compared with the placebo group . In addition , extract administration reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT Background The risk of cardiovascular diseases ( CVD ) is increased tremendously among menopausal women , and there is an increasing dem and for alternative therapies for managing factors like dyslipidemia that contribute to CVD development . Methods In this study , Nigella sativa was evaluated for its hypolipidemic effects among menopausal women . In a r and omised trial , hyperlipidemic menopausal women were assigned to treatment ( n = 19 ) or placebo groups ( n = 18 ) , and given N. sativa or placebo for two months after their informed consents were sought . At baseline , blood sample s were taken and at one month intervals thereafter until one month after the end of the study . Results The results showed that N. sativa significantly improved lipid profiles of menopausal women ( decreased total cholesterol , low density lipoprotein cholesterol and triglyceride , and increased high density lipoprotein cholesterol ) more than the placebo treatment over 2 months of intervention . One month after cessation of treatment , the lipid profiles in the N. sativa-treated group tended to change towards the pretreatment levels . Conclusions N. sativa is thought to have multiple mechanisms of action and is cost-effective . Therefore , it could be used by menopausal women to remedy hypercholesterolemia , with likely more benefits than with single pharmacological agents that may cause side effects . The use of N. sativa as an alternative therapy for hypercholesterolemia could have profound impact on the management of CVD among menopausal women especially in countries where it is readily available BACKGROUND Natural products are proved to play a good role as an alternative to synthetic chemicals in many clinical conditions . Hypercholesterolemia is the most important risk factor for atherosclerosis . Previous studies showed that Nigella sativa L. has both antioxidant and lipid lowering potentials . THE AIM OF THIS STUDY To evaluate the efficacy of the seeds of Nigella sativa on the treatment of hyperlipidemia . METHODS In this r and omized , placebo controlled clinical trial which was conducted in Isfahan city ( Iran ) , 88 subjects aged > or = 18 years with a total cholesterol concentration > 200 mg/dl were included . According to the patients " profiles number , they were r and omized to receive either N. sativa capsules or the matching placebo . Each N sativa capsule contained 500 + /- 10 mg N. sativa crushed seeds , and patients had to take 2 g N. sativa per day for 4 weeks . Fasting baseline laboratory values ( fasting blood sugar , total cholesterol , low density lipoprotein , high density lipoprotein and triglyceride ) were obtained for all parameters on each subject prior to the start OUTPUT: In addition , N. sativa reduced levels of glycosylated hemoglobin ( HbA1c ) . Our systematic review revealed that N. sativa supplementation might be effective in glycemic control in humans INPUT: Background Adjustment for prognostic covariates can lead to increased power in the analysis of r and omized trials . However , adjusted analyses are not often performed in practice . Methods We used simulation to examine the impact of covariate adjustment on 12 outcomes from 8 studies across a range of therapeutic areas . We assessed ( 1 ) how large an increase in power can be expected in practice ; and ( 2 ) the impact of adjustment for covariates that are not prognostic . Results Adjustment for known prognostic covariates led to large increases in power for most outcomes . When power was set to 80 % based on an unadjusted analysis , covariate adjustment led to a median increase in power to 92.6 % across the 12 outcomes ( range 80.6 to 99.4 % ) . Power was increased to over 85 % for 8 of 12 outcomes , and to over 95 % for 5 of 12 outcomes . Conversely , the largest decrease in power from adjustment for covariates that were not prognostic was from 80 % to 78.5 % . Conclusions Adjustment for known prognostic covariates can lead to substantial increases in power , and should be routinely incorporated into the analysis of r and omized trials . The potential benefits of adjusting for a small number of possibly prognostic covariates in trials with moderate or large sample sizes far outweigh the risks of doing so , and so should also be considered PURPOSE The aim of this study was to determine the toxic effect of Nigella sativa powder on the liver function which was evaluated by measuring liver enzymes and through histopathological examination of liver tissue . METHODS Twenty four male Sprague Dawley rats were allotted r and omly to four groups including : control ( taking normal diet ) ; low dose ( supplemented with 0.01 g/kg/day Nigella sativa ) ; normal dose ( supplemented with 0.1 g/kg/day Nigella sativa ) and high dose ( supplemented with 1 g/kg/day Nigella sativa ) . All of supplements administered in powder form mixed with rats ' pellet for 28 days . To assess liver toxicity , liver enzymes measurement and histological study were done at the end of supplementation . RESULTS The finding revealed that there was no significant change in serum alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) between treatment groups . Histopathological study showed very minimal and mild changes in fatty degeneration in normal and high doses of Nigella sativa treated group . Inflammation and necrosis were absent . CONCLUSION The study showed that supplementation of Nigella sativa up to the dose of 1 g/kg supplemented for a period of 28 days result ed no changes in liver enzymes level and did not cause any toxicity effect on the liver function Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P < 0.05–0.01 ) . Meanwhile , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P < 0.01 ) when compared with the placebo group . In addition , extract administration reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) . DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL OUTPUT:

Our data suggested that N.S supplementation had significant impacts on liver and kidney parameters leading to a decrease in ALP and BUN levels .

MS2_dynamic_1_shot55

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective —To assess whether adding a fibrate to statin therapy reduces residual cardiovascular risk associated with elevated triglycerides and low high-density lipoprotein cholesterol , The Evaluation of Choline Fenofibrate ( ABT-335 ) on Carotid Intima-Media Thickness ( cIMT ) in Subjects with Type IIb Dyslipidemia with Residual Risk in Addition to Atorvastatin Therapy ( FIRST ) trial evaluated the effects of fenofibric acid ( FA ) treatment on cIMT in patients with mixed dyslipidemia on atorvastatin . Approach and Results —This multicenter , double-blind , placebo-controlled study was performed in patients with mixed dyslipidemia ( fasting triglycerides , ≥150 mg/dL ; high-density lipoprotein cholesterol , ⩽45 [ men ] or 55 mg/dL [ women ] ; low-density lipoprotein cholesterol , ⩽100 mg/dL once and averaging ⩽105 mg/dL ) and a history of coronary heart disease or risk equivalent . Patients on background atorvastatin ( continued on starting dose or titrated to 40 mg , if needed ) were r and omized to FA 135 mg or placebo . The primary end point was rate of change from baseline through week 104 of the mean posterior-wall cIMT , measured by ultrasound . In patients with controlled low-density lipoprotein cholesterol while on atorvastatin background therapy , rate of change in posterior-wall cIMT was similar with FA plus atorvastatin ( −0.006 mm/y ) versus atorvastatin monotherapy ( 0.000 mm/y ; P=0.22 ) . FA plus atorvastatin was favored ( P<0.05 ) in 5 of 24 prespecified subgroups : age ≥60 years , history of coronary artery disease , cIMT > 0.795 mm , triglycerides 170 to 235 mg/dL , and statin use at entry . Adverse events were consistent with the known safety profiles of both drugs ; however , FA plus atorvastatin was associated with a greater incidence of renal-related adverse events compared with atorvastatin monotherapy ( 6.5 % versus 0.9 % ) . Conclusions —Compared with atorvastatin monotherapy , FA plus atorvastatin did not further decrease cIMT progression in high-risk patients with mixed dyslipidemia BACKGROUND AND AIMS To assess the efficacy and safety of K-877 ( Pemafibrate ) , a novel selective peroxisome proliferator-activated receptor α modulator ( SPPARMα ) that possesses unique PPARα activity and selectivity , compared with placebo and fenofibrate in dyslipidaemic patients with high triglyceride ( TG ) and low high-density lipoprotein cholesterol ( HDL-C ) levels . METHODS AND RESULTS This study was a double blind , placebo-controlled , parallel-group 12-week clinical trial . The study r and omized 224 patients to K-877 0.025 , 0.05 , 0.1 , 0.2 mg BID , fenofibrate 100 mg QD , or placebo ( 1:1:1:1:1:1 ) groups . Least squares mean percent changes from the baseline TG levels were -30.9 % , -36.4 % , -42.6 % , -42.7 % for the K-877 0.025 , 0.05 , 0.1 , 0.2 mg BID respectively ( p < 0.001 ) , which were greater than that of the fenofibrate 100 mg QD ( -29.7 % , p < 0.001 ) group . Statistically significant improvements from the baseline HDL-C , very-low-density lipoprotein cholesterol , chylomicron cholesterol , remnant lipoprotein cholesterol , apolipoprotein ( apo ) B ( apoB ) , and apoC-III were also observed in the K-877 groups . The incidence of adverse events ( AEs ) in the K-877 groups ( 32.4 - 56.8 % ) was comparable to those in placebo ( 47.2 % ) and fenofibrate 100 mg QD ( 56.8 % ) ; adverse drug reactions ( ADRs ) in the K-877 groups ( 2.7 - 5.4 % ) were less than those in placebo ( 8.3 % ) and fenofibrate 100 mg QD ( 10.8 % ) groups . CONCLUSION In dyslipidaemic patients with high TG and low HDL-C , K-877 improved TG , HDL-C , and other lipid parameters without increasing AEs or ADRs , compared to placebo and fenofibrate . K-877 can be expected to improve atherogenicity and to be a new beneficial treatment for dyslipidaemic patients BACKGROUND AND AIMS Substantial residual cardiovascular risks remain despite intensive statin treatment . Residual risks with high triglyceride and low high-density lipoprotein cholesterol are not the primary targets of statins . K-877 ( pemafibrate ) demonstrated robust efficacy on triglycerides and high-density lipoprotein cholesterol and a good safety profile as a monotherapy . The aim of these studies was to evaluate the efficacy and safety of K-877 add-on therapy to treat residual hypertriglyceridaemia during statin treatment . METHODS The objectives were investigated in two , multicentre , r and omised , double-bl OUTPUT: Conclusions The lipid profile significantly improved in the pemafibrate group than in the placebo group . In addition to the pemafibrate group having an improved lipid profile , which was comparable with that of the fenofibrate group , the AEs were significantly lower than in the fenofibrate group and an improvement in hepatobiliary enzyme activity was also recognized . INPUT: Abstract Background : The lipid-lowering effect of fenofibrate is accompanied by a rise in plasma homocysteine ( HCY ) , a potential risk factor for venous thromboembolism ( VTE ) . This study investigated the relationship between HCY and the risk of VTE in patients treated with fenofibrate . Methods : The relationship between HCY and deep-vein thrombosis or pulmonary embolism was investigated in 9522 participants of the 5-year Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) trial . All subjects received fenofibrate during a 6-week active run-in phase before r and omization . A Cox proportional-hazards model was used to assess the effect of HCY on risk of venous thromboembolic events . Results : During active-drug run-in , HCY rose on average by 6.5 μmol/L , accompanied by a substantial rise in plasma creatinine ( + 12 % ) . Fenofibrate-induced changes in HCY and creatinine were fully reversible in the placebo group but persisted in the treatment group until reversing at the end of therapy . During follow-up , 1.8 % had at least one episode of deep-vein thrombosis or pulmonary embolism : 103 on fenofibrate and 68 on placebo ( log-rank p=0.006 ) . In multivariate analysis , every 5 μmol/L higher baseline HCY was associated with 19 % higher risk of VTE . Fenofibrate treatment was associated with 52 % higher risk , but the change in HCY with fenofibrate was not significantly associated with VTE after adjustment for baseline HCY . Conclusions : Hyperhomocysteinemia is prospect ively associated with VTE . Fenofibrate may predispose individuals with high pretreatment HCY towards VTE . The fenofibrate-induced increase in HCY did not , however , explain the risk associated with fenofibrate therapy This study aim ed to compare the effects of ω-3 fatty acids and fibrate treatment on plasma levels and activities of hemostatic risk factors on glucose and lipid metabolism in subjects with isolated hypertriglyceridemia . Seventy-three subjects with elevated triglyceride levels were allocated into one of the following treatment options : bezafibrate ( 200 mg twice daily ) , ω-3 fatty acids ( 1 g twice daily ) or placebo . Plasma lipids , glucose homeostasis markers ( fasting and 2-h post-glucose load plasma glucose levels and HOMA ) , as well as plasma levels/activities of fibrinogen , factor VII and PAI-1 were determined at baseline , on the day of r and omization , and after 4 and 12 weeks of the treatment . Not only did bezafibrate improve plasma lipids , but it also increased glucose sensitivity and tended to reduce post-glucose loads of plasma glucose . Except for the reduction in plasma triglycerides , ω-3 fatty acids produced no effect on the lipid profile and insulin sensitivity . Both treatment options reduced , to similar extents , plasma levels of fibrinogen and PAI-1 and factor VII coagulant activity . Our study indicates that , although fibrates exhibit more-pronounced metabolic effects than do ω-3 fatty acids , both these treatment options are equipotent in producing a complex beneficial effect on hemostasis in isolated hypertriglyceridemic subjects Summary The effects of bezafibrate 400 mg/day ( slow release formulation ) on plasma lipids/lipoproteins and on selected haemostatic parameters were evaluated in a double blind cross-over study in patients with Type IIb and IV hyperlipoproteinaemia . Placebo treatment did not influence any of those parameters , but the drug significantly reduced plasma triglycerides ( −45 % ) and VLDL cholesterol , as well as causing a 12 % fall in total cholesterol and a 20 % increase in HDL cholesterol . Apo AI levels were significantly increased following bezafibrate and Apo B was reduced by about 20 % . In addition to changes in the plasma lipid profile , bezafibrate reduced the sensitivity of platelets to the aggregatory effect of collagen , with no effect on TXB2 production . Fibrinogen levels after bezafibrate treatment were significantly lowered , the effect being more marked in patients with hyperfibrinogenaemia . Bezafibrate did not influence the plasma fibrinolytic profile . It is concluded that bezafibrate , besides its beneficial effects on the plasma lipoprotein profile , can exert beneficial changes on specific haemostatic parameters Summary Background Amputations in people with type 2 diabetes mellitus substantially impair their quality of life and impose high costs on health-care systems . Our aim was to assess the effect of fenofibrate on amputation events in a large cohort of patients with type 2 diabetes . Methods In the Fenofibrate Intervention and Event Lowering in Diabetes ( FIELD ) study , 9795 patients aged 50–75 years with type 2 diabetes were r and omly assigned by computer-generated r and omisation sequence to receive fenofibrate 200 mg per day ( n=4895 ) or matching placebo ( n=4900 ) for 5 years ' duration . Information about non-traumatic amputation — a prespecified tertiary endpoint of the study —was routinely gathered . Clinicians who were masked to treatment allocation adjudicated amputations as minor or major ( below or above the ankle , respectively ) . Amputations were also classified on the basis of whether or not large-vessel disease was present in the limb , to distinguish those related to large-artery atherosclerosis from those predominantly related to microvascular disease . Analysis was by intention to treat ( ITT ) . The FIELD study is registered as an International St and ard R and omised Controlled Trial , number IS R OUTPUT:

The estimated effects of fibrate therapy on plasma concentration and activity of PAI-1 were independent of treatment duration and changes in plasma triglyceride levels in the meta-regression analysis . This meta- analysis of RCTs suggested that fibrate therapy does not reduce plasma concentration or activity of PAI-I. The putative benefits of fibrate therapy in patients with cardiovascular disease appear to be exerted via mechanisms independent of effects on PAI-1

MS2_dynamic_1_shot56

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective To verify whether the combination of transcutaneous electrical neural stimulation ( TENS ) with oxybutynin in the treatment of women with overactive bladder ( OAB ) would be more effective than isolated treatments . Methods We r and omized 75 women with OAB , in three groups : GI—30 min TENS , twice a week ; GII — daily slow release 10 mg oxybutynin ; and GIII — TENS + oxybutynin ( multimodal ) ; all for 12 weeks . Patients were evaluated with vali date d question naires International Consultation on Incontinence-Short Form ( ICIQ-SF ) , International Consultation on Incontinence-OAB ( ICIQ-OAB ) , Symptom bother , and 3-day Voiding diary at weeks 0 , 12 , and 24 . Results The groups were similar before treatment . After treatment , all groups significantly improved in OAB symptoms and quality of life ( QoL ) . At week 12 , ICIQ-OAB scores were 5.9 , 4.6 , and 2.9 , in groups I , II , and III , respectively , p = 0.01 . At week 24 , GI and GIII kept the scores of the end of treatment ( week 12 ) , while GII increased ICIQ-OAB from 4.6 to 9.2 , p = 0.0001 , ICIQ-SF from 9.8 to 13.3 , p = 0.0006 , and Symptom bother score from 3.4 to 7.0 , p = 0.0001 . Conclusions The multimodal treatment was more effective and TENS alone or in association presented longer lasting results for improvement of clinical symptoms of OAB and Aims : This study compared the effectiveness of solifenacin succinate ( SS ) versus percutaneous tibial nerve stimulation ( PTNS ) in women with overactive bladder syndrome ( OABS ) . Methods : A r and omized controlled crossover study of 40 women with OABS was performed . Patients were r and omized into two groups . In group A , patients received SS and then PTNS . In group B , patients underwent PTNS and then SS . Voiding diaries , quality of life surveys and patient perception of intensity of urgency question naire were performed before and after each treatment . The global impression of improvement question naire was performed at the end of the study . Results : A reduction in the number of daily micturitions , episodes of nocturia and urge incontinence were found with both SS and PTNS in all groups , but PTNS showed a greater effectiveness than SS . There was an increase in voided volume in all groups with both SS and PTNS , but patients treated with PTNS had a greater increase . PTNS showed greater effectiveness in patient perception of urgency and quality of life . Conclusion : This study demonstrates the effectiveness of SS and PTNS In women with overactive bladder symptoms . However , greater improvements were found with PTNS OBJECTIVE In sacral as well as tibial nerve stimulation test stimulation is the main prognostic factor for success . In our study we tried to identify prognostic patient characteristics to improve patient selection for neuromodulation therapy . METHODS PTNS was applied to 132 patients in 8 study centers ( 51 men , 81 women , mean age of 53 years ( range : 21 - 82 ) ) . 83 patients were treated for overactive bladder , 16 for non-obstructive urinary retention and 33 for chronic pelvic pain . All patients had to fill out micturition or pain diaries , as well as quality of life question naires before and after treatment . Patient characteristics were evaluated for their prognostic value for successful outcome of neuromodulation therapy with use of logistic regression . RESULTS Objective success was seen in 32.6 % of patients , subjective success in 51.5 % . Most evaluated clinical parameters proved not to be of prognostic value . A history of sexual and /or physical abuse was found in 12 of 103 interviewed patients , but did not alter PTNS treatment outcome . However , a low total score at baseline in the SF-36 question naire proved to be predictive for not obtaining objective ( OR 0.444 [ 95 % CI : 0.198 - 0.996 ] , p = 0.04 ) or subjective success ( OR 0.424 [ CI : 0.203 - 0.887 ] , p = 0.02 ) . Especially patients with a low SF-36 Mental Component Summary were prone to fail neuromodulation therapy : OR 0.123 ( 95 % CI : 0.273 - 0.552 ) , p = 0.006 for objective success . These patients also scored worse on disease-specific quality of life question naires , although they had no different disease severity compared to patients with good mental health . CONCLUSION Bad mental health as measured with the SF-36 Mental Component Summary does not depend on symptom severity and is a negative predictive factor for success of percutaneous tibial nerve stimulation . It therefore might be used as a tool for better patient selection in neuromodulation therapy Objective To perform Stoller afferent neurostimulation ( SANS ) with and without a low-dose anticholinergic ( oxybutynin hydrochloride ) in patients with detrusor overactivity and compare the results obtained with the two therapeutic approaches . Material and methods A total of 43 patients with symptoms of detrusor overactivity ( frequency , urgency , urge incontinence ) underwent urodynamic studies ( UDS ) . Those in whom UDS revealed phasic detrusor overactivity were evaluated using a quality of life question naire and voiding diaries . Patients were r and omized into two groups : Group 1 received SANS alone ; Group 2 received SANS combined with a low-dose anticholinergic ( 5 mg of oral oxybutyn OUTPUT: there is an evidence of effectiveness of short term PTNS in treatment of non-neurogenic OAB . PTNS is proven significantly better than sham procedure INPUT: Objective To verify whether the combination of transcutaneous electrical neural stimulation ( TENS ) with oxybutynin in the treatment of women with overactive bladder ( OAB ) would be more effective than isolated treatments . Methods We r and omized 75 women with OAB , in three groups : GI—30 min TENS , twice a week ; GII — daily slow release 10 mg oxybutynin ; and GIII — TENS + oxybutynin ( multimodal ) ; all for 12 weeks . Patients were evaluated with vali date d question naires International Consultation on Incontinence-Short Form ( ICIQ-SF ) , International Consultation on Incontinence-OAB ( ICIQ-OAB ) , Symptom bother , and 3-day Voiding diary at weeks 0 , 12 , and 24 . Results The groups were similar before treatment . After treatment , all groups significantly improved in OAB symptoms and quality of life ( QoL ) . At week 12 , ICIQ-OAB scores were 5.9 , 4.6 , and 2.9 , in groups I , II , and III , respectively , p = 0.01 . At week 24 , GI and GIII kept the scores of the end of treatment ( week 12 ) , while GII increased ICIQ-OAB from 4.6 to 9.2 , p = 0.0001 , ICIQ-SF from 9.8 to 13.3 , p = 0.0006 , and Symptom bother score from 3.4 to 7.0 , p = 0.0001 . Conclusions The multimodal treatment was more effective and TENS alone or in association presented longer lasting results for improvement of clinical symptoms of OAB and Purpose This study assessed the benefit of adding behavioural modification to darifenacin treatment for overactive bladder ( OAB ) . Material s and methods The ABLE trial was a r and omised , open-label , parallel-group , multicentre study of 12 weeks of darifenacin treatment [ with voluntary up-titration from 7.5 mg once daily ( qd ) to 15 mg qd at week 2 ] alone or in combination with a Behavioural Modification Programme ( BMP ) for men and women with dry or wet OAB . Efficacy was assessed as the change in the number ( per day ) of micturitions ( primary variable ) , urge urinary incontinence ( UUI ) episodes , urgency episodes , pads used and nocturnal voids . Health-related quality of life ( HRQoL ) was also evaluated . Tolerability and safety assessment s included adverse events and the number of discontinuations . Results Of 592 patients screened , 395 were r and omised , 190 to darifenacin alone and 205 to darifenacin + BMP . At baseline , the majority of subjects were dry ( mean 2.8 and three UUI episodes per day in the darifenacin and darifenacin + BMP groups respectively ) . At study end , darifenacin alone and darifenacin + BMP both produced significant reductions from baseline in median numbers of micturitions , UUI episodes , urgency episodes and nocturnal voids ( all p < 0.05 ) , but not in the number of pads used . HRQoL also improved . There were no significant differences between treatment groups in efficacy or HRQoL variables . Conclusions Darifenacin treatment provides a degree of normalisation of micturition variables and improvement in HRQoL that can not be further enhanced by behavioural therapy of the type used in this study . Whether behavioural modification would add benefit over darifenacin treatment in patients with more pronounced incontinence problems remains to be determined Background To assess the efficacy and safety of the herbal medicine , Weng-li-tong ( WLT ) as monotherapy or combined with tolterodine in women with overactive bladder ( OAB ) . Methods A prospect i ve , r and omized , single-blind multi-center trial was performed which included 182 OAB patients treated with either placebo ( n = 26 ) , WLT ( n = 52 ) , tolterodine ( n = 52 ) or WLT plus tolterodine ( n = 52 ) . The overactive bladder symptom score ( OABSS ) and micturition behavior were measured to evaluate treatment efficacy . Results In total , 146 patients [ placebo ( n = 23 ) , WLT ( n = 39 ) , tolterodine ( n = 41 ) and WLT plus tolterodine ( n = 43 ) ] completed 8 weeks of treatment . Compared to those treated with placebo , patients in three intervention groups showed significant improvements in the OABSS , voiding frequency , average voided volume and urgency incontinence . WLT had a slower onset than tolterodine or combination therapy in reducing urgency incontinence . Compared with tolterodine , WLT had a weaker effect in improving OABSS ( P = 0.022 ) and daily voiding frequency ( P = 0.034 ) . The combination therapy had better efficacy than WLT or tolterodine alone in improving the OABSS , voiding frequency and voided volume . No significant differences in the changes in quality of life scores were observed among the three intervention groups . Residual urine increased significantly in tolterodine group ( P = 0.004 ) , but not in combination group . WLT result ed in fewer adverse effects than tolterodine such as dry mouth ( P = 0.002 ) , weak stream ( P = 0.002 ) and less residual urine ( P < 0.001 ) . Conclusions WLT could improve OAB symptoms in women , while it had slower onset and weaker efficacy but fewer adverse effects than tolterodine . The combination of WLT and tolterodine was more efficacious than tolterodine alone in improving OAB symptoms . Trial registration Chinese Clinical Trial Registry [ ChiCTR- OUTPUT:

Combination therapy studies of third-line treatments were rare and centered on medication with PTNS . Combination therapy , with certain first , second , and third-line OAB therapies , appears to be efficacious .

MS2_dynamic_1_shot57

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The purpose of this study was to compare the rate of gastric emptying of 20 g.l-1 ( 2 G ) , 40 g.l-1 ( 4 G ) , and 60 g.l-1 ( 6 G ) glucose solutions with that of water ( W ) . On separate occasions in r and omized order , a 600-ml test solution was instilled into the stomach of each of six healthy male volunteers . Gastric emptying was measured at 10-min intervals for 1 h by a double sampling gastric aspiration method that allowed the volume of test drink and of the gastric secretion present in the stomach to be measured at each time point . All solutions emptied rapidly and followed an exponential emptying pattern . The 20 g.l-1 glucose solution was emptied at the same rate as water . After the first 10 min of rapid emptying , 4 G and 6 G were emptied slower ( P < 0.05 ) than water . 6 G delivered more ( P < 0.05 ) glucose to the small intestine than 4 G , and 4 G delivered more glucose than 2 G . The results indicate that a 20 g.l-1 glucose solution has no effect on gastric emptying compared with water , but that after the first 10 min of rapid emptying , glucose solutions at a concentration of 40 g.l-1 or more delay gastric emptying To verify the influence of food consistency on satiety mechanisms we evaluated the effects of the same meal in solid-liquid ( SM ) and homogenized ( HM ) form on satiety sensation , gastric emptying rate and plasma cholecystokinin ( CCK ) concentration . Eight healthy men , aged 21 - 28 ( mean 24.5 ) years were given two meals ( cooked vegetables 250 g , cheese 35 g , croutons 50 g and olive oil 25 g , total energy 2573 kJ , with water 300 ml ) differing only in physical state : SM and HM . The subjects consumed the meals in r and omized order on non-consecutive days . The sensations of fullness , satiety and desire to eat were evaluated by means of a question naire , gastric emptying was assessed by ultrasonographic measurement of antral area , and plasma CCK concentration was measured by radioimmunoassay . The vegetable-rich meal was significantly more satiating ( P < 0.05 ) when in the HM form than when eaten in a SM state . Furthermore , the overall gastric emptying time was significantly slowed ( 255 ( SEM 11 ) min after HM v. 214 ( SEM 12 ) min after SM ; P < 0.05 ) and CCK peak occurred later ( 94 ( SEM 12 ) min after HM v. 62 ( SEM 11 ) min after SM ; NS ) when the food was consumed in the HM form . Independently of the type of meal , antral area was significantly related to fullness sensations ( r2 0.46 , P = 0.004 ) . These results demonstrate that meal consistency is an important physical food characteristic which influences both gastric emptying rate and satiety sensation . Moreover , the relationship observed between antral area and fullness sensation confirms that antral distension plays a part in the regulation of eating behaviour Postpr and ial lipaemia may lead to an increase in oxidative stress , inducing endothelial dysfunction . Exercise can slow gastric emptying rates , moderating postpr and ial lipaemia . The purpose of this study was to determine if moderate exercise , prior to fat ingestion , influences gastrointestinal transit , lipaemia , oxidative stress and arterial wall function . Eight apparently healthy males ( age 23.6 ± 2.8 yrs ; height 181.4 ± 8.1 cm ; weight 83.4 ± 16.2 kg ; all data mean ± SD ) participated in the r and omised , crossover design , where ( i ) subjects ingested a high-fat meal alone ( control ) , and ( ii ) ingested a high-fat meal , preceded by 1 h of moderate exercise . Pulse Wave Velocity ( PWV ) was examined at baseline , post-exercise , and in the postpr and ial period . Gastric emptying was measured using the 13C-octanoic acid breath test . Measures of venous blood were obtained prior to and following exercise and at 2 , 4 and 6 hours post-ingestion . PWV increased ( 6.5 ± 1.9 m/sec ) at 2 ( 8.9 ± 1.7 m/sec ) and 4 hrs ( 9.0 ± 1.6 m/sec ) post-ingestion in the control group ( time × group interaction , P < 0.05 ) . PWV was increased at 2 hrs post-ingestion in the control compared to the exercise trial ; 8.9 ± 1.7 vs. 6.2 ± 1.5 m/sec ( time × group interaction , P < 0.05 ) . Lipid hydroperoxides increased over time ( pooled exercise and control data , P < 0.05 ) . Serum triacylglycerols were elevated postpr and ially ( pooled exercise and control data , P < 0.05 ) . There were no changes in gastric emptying , cholesterol , or C-reactive protein levels . These data suggest that acute exercise prior to the consumption of a high-fat meal has the potential to reduce vascular impairments Gastric emptying , as well as intragastric meal distribution , and gastrointestinal hormones , including cholecystokinin ( CCK ) , play an important role in appetite regulation . The evaluation of gastrointestinal factors regulating food intake is commonly performed in healthy , lean , young male participants . It has , however , been suggested that there is a marked interindividual variability in OUTPUT: There was a dose response of exercise intensity ; at lower intensities GE was faster , and at high exercise intensities GE was slower . Walking was associated with faster GE and cycling with slower GE . Greater volume of meal/fluid ingested , higher osmolality of beverage and longer exercise duration were also associated with slower GE with exercise . Conclusions These results suggest that exercise intensity , mode , duration and the nature of meal/fluid ingested all influence GE during and after acute exercise . INPUT: Underst and ing the impact of rheological properties of food on postpr and ial appetite and glycemic response helps to design novel functional products . It has been shown that solid foods have a stronger satiating effect than their liquid equivalent . However , whether a subtle change in viscosity of a semi-solid food would have a similar effect on appetite is unknown . Fifteen healthy males participated in the r and omized cross-over study . Each participant consumed a 1690 kJ portion of a st and ard viscosity ( SV ) and a high viscosity ( HV ) semi-solid meal with 1000 mg acetaminophen in two separate sessions . At regular intervals during the three hours following the meal , subjective appetite ratings were measured and blood sample s collected . The plasma sample s were assayed for insulin , glucose-dependent insulinotropic peptide ( GIP ) , glucose and acetaminophen . After three hours , the participants were provided with an ad libitum pasta meal . Compared with the SV meal , HV was consumed at a slower eating rate ( P = 0.020 ) , with postpr and ial hunger and desire to eat being lower ( P = 0.019 and P<0.001 respectively ) while fullness was higher ( P<0.001 ) . In addition , consuming the HV result ed in lower plasma concentration of GIP ( P<0.001 ) , higher plasma concentration of glucose ( P<0.001 ) and delayed gastric emptying as revealed by the acetaminophen absorption test ( P<0.001 ) . However , there was no effect of food viscosity on insulin or food intake at the subsequent meal . In conclusion , increasing the viscosity of a semi-solid food modulates glycemic response and suppresses postpr and ial satiety , although the effect may be short-lived . A slower eating rate and a delayed gastric emptying rate can partly explain for the stronger satiating properties of high viscous semi-solid foods BACKGROUND Many preoperative fasting guidelines suggest that hot tea or coffee with milk added should be considered similar to solid food , allowing an interval of 6 h before commencing anaesthesia . There is little evidence to support these instructions , with recent guidelines undecided on the issue . This study aim ed to establish whether there was a clinical ly significant delay in gastric emptying associated with adding a modest amount of milk to tea . METHODS This r and omized controlled crossover study was conducted in 10 healthy volunteers . The paracetamol absorption technique and real-time ultrasound measurement of the cross-sectional area of the gastric antrum were used to assess gastric emptying after ingestion of 300 ml of black tea or 300 ml of tea with milk ( 250 ml black tea plus 50 ml of full fat milk ) . RESULTS The mean difference in the time to reach the peak paracetamol concentration ( tmax ) was -8 min [ 95 % confidence interval ( CI ) -23.1 to 7 ] in favour of tea with milk . Ultrasound assessment indicated that the geometric mean of the half-time to gastric emptying ( T₁/₂ ) after tea without milk was 22.7 ( 95 % CI 12.7 - 40.9 ) min and after tea with milk 23.6 ( 95 % CI 13.5 - 41.0 ) min ( ratio 1.04 ) ( 95 % CI 0.47 - 2.29 ) . CONCLUSIONS This study demonstrated no difference in gastric emptying times when a modest amount of milk was added to tea . These findings suggest that it may be acceptable to allow patients to add a small quantity of milk to their tea or coffee and follow the same fasting restrictions applied to clear fluids BACKGROUND In emergency medicine , the gastric tube ( GT ) has many purpose s , however in prehospital setting s , the only indication is gastric decompression . To date , there is lack of recommendation on the diagnostic methods to verify correct GT placement in prehospital . The aim of this study is to estimate diagnostic accuracy of ultrasound in confirming gastric tubes placement in a prehospital setting . METHOD This was a prospect i ve multicentre study conducted in two French towns ( Marseille and Grasse ) over a one-year period from May 2010 to May 2011 . RESULTS One hundred and thirty patients were included in the study with an M/F sex ratio of 77/53 and a mean age of 55.7±19.8 years . The GT position was confirmed by ultrasound , with direct visualization in the gastric area in 116 of the 130 patients . In 14 cases , the ultrasound failed to visualize the tip of the GT ; these results were due in 2 cases to gas interposition and in 12 cases the GT was shown by final X-ray to be located in the end of the oesophagus . Direct visualization by ultrasound thus has a sensitivity of 98.3 % [ 94 - 99.5 ] and a specificity of 100 % [ 75.7 - 100 ] , a positive predictive value of 100 % and a negative predictive value of 85.7 % , Youden 's index of 0.98 . GT size affects ultrasound visualization ; the larger the GT , the easier it is to see . CONCLUSION Bedside ultrasound thus appears to constitute an effective and reliable diagnostic procedure for confirming correct gastric tube placement in prehospital setting 1 . This study examined the effects of caloric content ( caloric density and the nature of calories ) on the rate of gastric emptying using the double-sampling gastric aspiration technique . Four test meals of 600 ml ( glucose , 0.1 kcal ml-1 ; pea and whey peptide hydrolysates , both 0.2 kcal ml-1 ; milk protein OUTPUT:

Taking knee arthroplasty as an example , patients deemed at low risk of experiencing outcomes such as postoperative pain or chronic pain may receive intra-articular local anaesthesia infiltration ; patients at medium risk may obtain additional analgesia via a saphe-nous nerve catheter ; and patients at high risk may also receive nerve blocks and anti-hyperalgesics . pain and function after fast-track hip and knee arthroplasty . catastrophizing , response to experimental heat stimuli , and post-cesarean section pain . In 1946 , Mendelson 1 showed that pulmonary complications and death could arise in pregnant women because of aspiration of gastric contents . Since then , prevention of aspiration of gastric contents has contributed significantly to a decrease in maternal deaths . Warner and colleagues 2 demonstrated in a large series from the Mayo Clinic that no aspiration occurred in pregnant or post-partum women ( probably because of the routine use of prophylactic measures ) , while both its occurrence and severity were significant in emergency procedures .

MS2_dynamic_1_shot58

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Introduction Hypothalamic-pituitary-adrenal ( HPA ) deregulation is commonly observed in cancer patients , but its clinical significance is not well understood . We prospect ively examined the association between HPA activity , tumor-associated inflammation , and survival in ovarian cancer patients prior to treatment . Material s and Methods Participants were 113 women with ovarian cancer who provided salivary cortisol for three days prior to treatment for calculation of cortisol slope , variability , and night cortisol . Cox proportional hazard regression analyses were used to examine associations between cortisol and survival in models adjusting for disease stage , tumor grade , cytoreduction and age . On a sub sample of 41 patients with advanced disease ascites fluid was assayed for levels of interleukin-6 ( IL-6 ) and correlated with cortisol variables . Results Each cortisol measure was associated with decreased survival time , adjusting for covariates ( all p<.041 ) . A one st and ard deviation increase in night cortisol was associated with a 46 % greater likelihood of death . Patients in the high night cortisol group survived an estimated average of 3.3 years compared to 7.3 years for those in the low night cortisol group . Elevated ascites IL-6 was associated with each cortisol measure ( all r > .36 , all p<.017 ) . Discussion Abnormal cortisol rhythms assessed prior to treatment are associated with decreased survival in ovarian cancer and increased inflammation in the vicinity of the tumor . HPA abnormalities may reflect poor endogenous control of inflammation , dysregulation caused by tumor-associated inflammation , broad circadian disruption , or some combination of these factors . Nocturnal cortisol may have utility as a non-invasive measure of HPA function and /or disease severity CONTEXT Changes in and rogen levels across the adult female life span and the effects of natural menopause and oophorectomy have not been clearly established . OBJECTIVE The objective of this study was to document the effects of age on and rogen levels in healthy women and to explore the effects of natural and surgical menopause . DESIGN , SETTING , AND PARTICIPANTS A cross-sectional study was conducted of 1423 non-healthcare-seeking women , aged 18 - 75 yr , r and omly recruited from the community over 15 months . MAIN OUTCOME MEASURES Serum levels by age of total testosterone ( T ) , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione in a reference group of women free of confounding factors . Women in the reference group had no usage of exogenous steroid therapy ; no history of tubal ligation , hysterectomy , or bilateral oophorectomy ; and no hyperprolactinemia or polycystic ovarian syndrome . The effects of natural and surgical menopause on sex steroid levels were also examined . RESULTS In the reference population ( n = 595 ) , total T , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione declined steeply with age ( P < 0.001 ) , with the decline of each being greater in the earlier than the later decades . Examination of serum and rogen levels by year in women aged 45 - 54 yr showed no independent effect of menopausal status on and rogen levels . In women aged 55 yr or older , those who reported bilateral oophorectomy and were not on exogenous steroids had significantly lower total T and free T levels than women 55 yr or older in the reference group . CONCLUSIONS We report that serum and rogen levels decline steeply in the early reproductive years and do not vary because a consequence of natural menopause and that the postmenopausal ovary appears to be an ongoing site of testosterone production . These significant variations in and rogens with age must be taken into account when normal ranges are reported and in studies of the role of and rogens in women Background Current reporting guidelines do not call for st and ardised declaration of follow-up completeness , although study validity depends on the representativeness of measured outcomes . The Follow-Up Index ( FUI ) describes follow-up completeness at a given study end date as ratio between the investigated and the potential follow-up period . The association between FUI and the accuracy of survival-estimates was investigated . Methods FUI and Kaplan-Meier estimates were calculated twice for 1207 consecutive patients undergoing aortic repair during an 11-year period : in a scenario A the population ’s clinical routine follow-up data ( available from a prospect i ve registry ) was analysed conventionally . For the control scenario B , an independent survey was completed at the predefined study end . To determine the relation between FUI and the accuracy of study findings , discrepancies between scenarios regarding FUI , follow-up duration and cumulative survival-estimates were evaluated using multivariate analyses . Results Scenario A noted 89 deaths ( 7.4 % ) during a mean considered follow-up of 30±28months . Scenario B , although analysing the same study period , detected 304 deaths ( 25.2 % , P<0.001 ) as it scrutinized the complete follow-up period ( 49±32months ) . FUI ( 0.57±0.35 versus 1.00±0 , P<0.001 ) and cumulative survival estimates ( 78.7 % versus 50.7 % , P<0.001 ) differed significantly between scenarios , suggesting that incomplete follow-up information led to underestimation of mortality . Degree of follow-up completeness ( i.e. FUI-quartiles and FUI-intervals ) correlated directly with accuracy of study findings : underestimation of long-term mortality increased almost linearly by 30 % with every 0.1 drop in FUI ( adjusted HR 1.30 ; 95%-CI 1.24 OUTPUT: Most studies focused on cancer risk prediction , followed by diagnosis , prognosis , and therapy monitoring . Prostate cancer was the most frequently studied cancer . Estradiol , dehydroepi and rosterone , and cortisol were mostly reported and altered in at least four types of cancer . Estrogen and estrogen metabolites were highly reported to associate with women-related cancers . Pathway enrichment analysis revealed that steroidogenesis ; and rogen and estrogen metabolism ; and and rostenedione metabolism were significantly altered in cancers . Our findings indicated that estradiol , dehydroepi and rosterone , cortisol , and estrogen metabolites , among others , could be considered oncosteroids . INPUT: The hypothalamo-pituitary-adrenal ( HPA ) axis is modulated by sex hormones . Few data exist on the relation between acute estrogen deficit and HPA axis response to corticotropin-releasing hormone ( CRH ) . The effects of a sudden drop in estradiol levels on basal and CRH-stimulated levels of ACTH , cortisol , testosterone , and rostenedione and 17-hydroxyprogesterone ( 17-OHP ) were assessed in nine premenopausal women ( 44 - 48 years of age ) , before and after ovariectomy . The CRH test was performed before and 8 days after ovariectomy . A significant reduction in ACTH and adrenal steroids but not in cortisol response to CRH was observed after ovariectomy . The ratio of deltamax and rostenedione/17-OHP after CRH stimulation was substantially the same before and after ovariectomy , whereas deltamax 17-OHP/cortisol was significantly lower in ovariectomized women showing increased 21- and 11beta-hydroxylase activity . The results show that the acute estrogen deficit induces changes in the HPA axis characterized by reduced stimulated secretion of ACTH and steroids but normal stimulated cortisol production CONTEXT Changes in and rogen levels across the adult female life span and the effects of natural menopause and oophorectomy have not been clearly established . OBJECTIVE The objective of this study was to document the effects of age on and rogen levels in healthy women and to explore the effects of natural and surgical menopause . DESIGN , SETTING , AND PARTICIPANTS A cross-sectional study was conducted of 1423 non-healthcare-seeking women , aged 18 - 75 yr , r and omly recruited from the community over 15 months . MAIN OUTCOME MEASURES Serum levels by age of total testosterone ( T ) , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione in a reference group of women free of confounding factors . Women in the reference group had no usage of exogenous steroid therapy ; no history of tubal ligation , hysterectomy , or bilateral oophorectomy ; and no hyperprolactinemia or polycystic ovarian syndrome . The effects of natural and surgical menopause on sex steroid levels were also examined . RESULTS In the reference population ( n = 595 ) , total T , calculated free T , dehydroepi and rosterone sulfate , and and rostenedione declined steeply with age ( P < 0.001 ) , with the decline of each being greater in the earlier than the later decades . Examination of serum and rogen levels by year in women aged 45 - 54 yr showed no independent effect of menopausal status on and rogen levels . In women aged 55 yr or older , those who reported bilateral oophorectomy and were not on exogenous steroids had significantly lower total T and free T levels than women 55 yr or older in the reference group . CONCLUSIONS We report that serum and rogen levels decline steeply in the early reproductive years and do not vary because a consequence of natural menopause and that the postmenopausal ovary appears to be an ongoing site of testosterone production . These significant variations in and rogens with age must be taken into account when normal ranges are reported and in studies of the role of and rogens in women OBJECTIVE To investigate the cross-sectional associations of hysterectomy and oophorectomy status , chronological age , and body mass index with early postoperative plasma levels of total and free T , DHEAS , and sex hormone-binding globulin ( SHBG ) . DESIGN A cross-sectional study . SETTING University hospital . PATIENT(S ) Ninety-two women age 35 - 47 years who were scheduled for hysterectomy and /or oophorectomy , advocated for benign gynecological pathologies . INTERVENTION(S ) Ninety-two eligible premenopausal women underwent hysterectomy and /or oophorectomy , with plasma T , DHEAS , and SHBG levels assayed before surgery and during the postoperative period . MAIN OUTCOME MEASURE(S ) Effects of time x operation and age x operation interactions between oophorectomized and nonoophorectomized groups and within-subject main effect of time on plasma and rogen levels . RESULT ( S ) Of 92 women , hysterectomy alone was performed in only 49 ( 53.3 % ) cases . Oophorectomy , either unilateral or bilateral , was performed in 35.8 % of cases . Age x within-group interactions exhibited an important difference ( P=.03 ) in total T levels . The time x between- and within-group interaction effects on plasma DHEAS levels of postoperative day 7 , compared with day 1 , were statistically significant ( P<.001 ) . The effect of time x group interaction was remarkable , in terms of SHBG levels during the postoperative period . Age x oophorectomy interaction exhibited a statistically significant change of decline in DHEAS levels on postoperative day 7 ( P=.05 ) . CONCLUSION ( S ) The present study demonstrated a time and operation effect decline in plasma DHEAS levels . In contrast , the time x operation interaction on SHBG levels exhibited an increase toward postoperative day 7 CONTEXT In postmenopausal women , endogenous bioavailable testosterone ( T ) and estradiol ( E2 ) have been positively associated , and SHBG has been negatively associated , with incident type 2 diabetes ( T2DM ) . Previous studies have not explored possible factors explaining these relationships . OBJECTIVE Our objective was to examine the association of endogenous sex hormones with incident T2DM in postmenopausal women and possible explanatory factors OUTPUT:

Subgroup analysis for assay type was statistically significant for spontaneous POI only . Sensitivity analyses of high- quality studies did not change the results , and result ed in a substantial decrease in heterogeneity in spontaneous POI studies . The current meta- analysis demonstrates that total testosterone concentrations are decreased in women with spontaneous POI or iatrogenic menopause .

MS2_dynamic_1_shot59

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: QUESTIONS UNDER STUDY In many countries newer non-benzodiazepines , zolpidem and zopiclone ( " Z-drugs " ) , are prescribed instead of benzodiazepine hypnotics . This is not supported by current evidence and guidelines . The aim of this study was to compare the perceptions of GPs on the benefits and harms of benzodiazepines and Z-drugs . METHODS A question naire was mailed to a r and om sample of 1,350 German GPs between May and June 2012 . GPs were asked to rate their perceptions on a five-point Likert scale for 12 items asked for both benzodiazepines and Z-drugs . Wilcoxon signed rank test for paired observations was used for comparison between groups . Due to multiple testing , only p values ≤0.01 were considered statistically significant . RESULTS A total of 458 question naires were returned ( response 33.9 % ) . The mean age of participants was 53.3 years ( 59.4 % males ) . GPs perceived that Z-drugs were significantly more effective in terms of reduced night-time waking , feelings of being rested on waking and improved daytime functioning than benzodiazepines ( p < 0.0001 for all comparisons ) , but not in terms of reduced time to get to sleep and increased total sleep time . All studied side effects were believed to be less often for patients receiving Z-drugs ( p < 0.0001 for all comparisons ) . A total of 73.4 % and 80.4 % answered that tolerance or withdrawal effects on stopping occur often or very often/always for benzodiazepines , whereas these values were only 30.6 % and 28.7 % for Z-drugs . CONCLUSIONS German GPs perceived that Z-drugs were more effective and safer compared to benzodiazepines , which is not supported by current evidence . The results are quite comparable to a British survey conducted seven years before Computerized symbol-digit substitution tests ( SDSTs ) and ' yes/no ' digit-symbol substitution tests ( YNDSTs ) , together with a digit-digit copying test ( DDCT ) were compared in a double-blind crossover study for hypnosedative and alcohol effects in 12 young healthy subjects . The tests were carried out before and 1 , 3.5 and 5 h after intake of 15 mg diazepam , 30 mg oxazepam , 7.5 mg zopiclone,15 mg zolpidem or 0.65 + 0.35 g/kg ethanol , these impaired performance by varying extents . The drug-induced decrements were similar in the YNDSTs and SDSTs ; the errors were subject-related and increased with alcohol intake in the YNDSTs but not in the SDSTs . Pooled baseline values in YNDSTs correlated well ( Pearson ) with those in the SDSTs . The SDSTs also correlated well with the DDCTs . The same correlations were seen when comparing absolute performances after ethanol and hypnosedatives . When using the Δ-values ( changes from baseline ) , the correlation betweenYNDSTs and SDSTs was high after placebo but low after alcohol and hypnosedatives . When using ANCOVA to measure the responses to drugs ( Δ-drug - Δ-placebo ) , the correlation between YNDSTs and SDSTs was fairly significant after most but not all active drugs . Subjective visual analogue variables did not correlate with objective performances . By comparing absolute performances with hypnosedatives we conclude that YNDSTs and SDSTs are similar , with the Δ-values indicating differences between them Abstract Rationale : The increased prevalence of sleep disturbance in old age is accompanied by a higher prescription rate of hypnotics , predominantly benzodiazepines in the elderly . In young volunteers zopiclone exerts a beneficial effect on sleep continuity without suppression of SWS and REM sleep ; psychomotor performance and vigilance seemed to be less impaired than under classical benzoediazepines . Objective : The present study investigates the effects of zopiclone on sleep EEG and cognitive performance in comparison to temazepam and placebo in the elderly population . Methods : Single oral doses of zopiclone ( 7.5 mg ) , temazepam ( 20 mg ) and placebo were administered in a r and omized double-blind , completely counterbalanced cross-over design to 12 healthy elderly men and women ( 65.9 + 3.6 years , range 60–70 years ) . On each of the 3 study nights a sleep EEG was registered from 10 p.m. to 6.30 a.m. and cognitive performance tests were applied at 8 p.m. , 2 a.m. ( when subjects were awake for 30 min ) , 7 a.m. and 9 a.m. Results : After zopiclone treatment , sleep continuity had significantly improved and sleep stage 4 was increased compared to temazepam and placebo . In addition , both active substances significantly reduced REM density . Neither active compound substantially altered psychomotor and memory performance . Conclusions : Zopiclone and temazepam can be considered as effective hypnotics in elderly subjects when administered in that dosage . The superiority of zopiclone on sleep architecture may be related to a more specific action of zopiclone at the GABA-A benzodiazepine receptor complex . The suppression of REM density by both compounds and their subtle effects on cognition may reflect a GABAergic mediated reduction of cholinergic neurotransmission The sedative , amnestic , and performance disruptive effects of benzodiazepine ( Bz ) receptor selective and non-selective hypnotics were studied in 23 healthy , normal subjects , aged 26.8±1.0 years . Triazolam ( 0.25 and 0.50 mg ) , zolpidem ( 10 and OUTPUT: An additional medium effect size was observed for zolpidem on attention . It is clear from these data that the use of a single dose of the z-drugs in healthy adults as measured in the morning following the exposure does produce a specific rather than a generalized negative effect on cognitive function . INPUT: Abstract Twenty-four volunteers ( 19 women and five men ) with insomnia and a history of chronic use of benzodiazepine hypnotics participated in a r and omized , double blind , controlled clinical trial . The study was design ed to assess the effects of substituting zopiclone ( ZOP ) – as an hypnotic – among chronic users of flunitrazepam ( FLU ) , and to compare the subsequent withdrawal of ZOP with placebo controlled withdrawal of FLU . During the 5 weeks of a withdrawal protocol , sleep and physiological parameters were assessed by polysomnographic measures for 11 nights and by nightly actigraphic recordings for weeks 1 , 3 , and 5 . Subjective effects of the withdrawal process were evaluated with daily sleep diaries , and with various weekly self-report symptom checklists . Paired t-tests performed on differences in objective sleep parameters between baseline and the last weeks of the withdrawal program showed a significant decrease in sleep quality within the FLU group , but not in the ZOP group . Subjective sleep diaries consistently reflected the objective ly measured changes in sleep throughout the withdrawal program , indicating significant changes in sleep parameters only in the FLU group . The results obtained from the self report inventories aim ed at assessing withdrawal symptoms , however , revealed no differences between the baseline week and the termination week of the program in any of the groups . After completing the pharmacological withdrawal , all subjects received a short-term cognitive behavioral intervention focused on improving their coping strategies with symptoms of insomnia ; they were evaluated immediately after concluding the intervention , and at 3 and 12 month follow-ups Eighty-six participants wishing to stop benzodiazepine and who met DSM-IV ( Diagnostic and Statistical Manual of Mental Disorders , 4th ed . American Psychological Association , 1994 ) criteria for anxiety disorder or insomnia were assessed pre- and post-taper on clinical , pharmacological and psychosocial measures . An initial cohort of 41 participants received treatment as usual ( taper only ) plus physician counselling in the same clinic setting . A second cohort of 45 participants were r and omly allocated to group cognitive-behavioural therapy ( CBT ) plus taper , or group support ( GS ) plus taper . At 3 months follow-up , the outcomes in both the CBT and the GS subgroups were equivalent . Intention to treat analysis revealed a slight advantage to the CBT over the GS group and the CBT group showed higher self-efficacy post-taper . Over all 86 participants , a high-baseline level of psychological distress , anxiety and dosage predicted a poor outcome , but increase in self-efficacy contributed to a successful outcome particularly in those with initially poor baseline predictors . Although there was a decrease in positive affect during preliminary stages of tapered discontinuation compared to baseline , there was no significant overall increase in negative affect BACKGROUND Benzodiazepines are extensively used in primary care , but their long-term use is associated with adverse health outcomes and dependence . AIMS To analyse the efficacy of two structured interventions in primary care to enable patients to discontinue long-term benzodiazepine use . METHOD A multicentre three-arm cluster r and omised controlled trial was conducted , with r and omisation at general practitioner level ( trial registration IS RCT N13024375 ) . A total of 532 patients taking benzodiazepines for at least 6 months participated . After all patients were included , general practitioners were r and omly allocated ( 1:1:1 ) to usual care , a structured intervention with follow-up visits ( SIF ) or a structured intervention with written instructions ( SIW ) . The primary end-point was the last month self-declared benzodiazepine discontinuation confirmed by prescription cl aims at 12 months . RESULTS At 12 months , 76 of 168 ( 45 % ) patients in the SIW group and 86 of 191 ( 45 % ) in the SIF group had discontinued benzodiazepine use compared with 26 of 173 ( 15 % ) in the control group . After adjusting by cluster , the relative risks for benzodiazepine discontinuation were 3.01 ( 95 % CI 2.03 - 4.46 , P<0.0001 ) in the SIW and 3.00 ( 95 % CI 2.04 - 4.40 , P<0.0001 ) in the SIF group . The most frequently reported withdrawal symptoms were insomnia , anxiety and irritability . CONCLUSIONS Both interventions led to significant reductions in long-term benzodiazepine use in patients without severe comorbidity . A structured intervention with a written individualised stepped-dose reduction is less time-consuming and as effective in primary care as a more complex intervention involving follow-up visits Withdrawal from hypnotics can produce a variety of problems , especially sleep difficulties , some of which may arise from the multiple actions of most hypnotics , thus producing a range of rebound effects . This study examined whether switching patients to a hypnotic with a narrower range of action and of a different class would reduce these problems . One hundred and thirty-four patients participated ; they were r and omly allocated to one of three methods of switching from " previous hypnotic " to zopiclone ( a cyclopyrrolone ) . The methods were gap ( an interval between taking the two drugs ) ; abuttal ( taking zopiclone immediately on stopping previous drug ) ; and overlap ( gradually reducing previous drug after starting zopiclone ) . The main findings were that zopiclone was associated with better sleep and increased alertness ; the abuttal method was the best method of switching ; and no serious side effects from zopiclone were reported . It was concluded that zopiclone has a useful role in benzodiazepine withdrawal , and that immediate substitution is the best method The Johns Hopkins Precursors Study , a long-term prospect i ve study , was used to study the relation between self-reported sleep disturbances OUTPUT:

This guideline does not apply to those with other sleep disorders or untreated anxiety , depression , or other physical or mental health conditions that might be causing or aggravating insomnia . Benzodiazepine receptor agonists are associated with harms , and therapeutic effects might be short term . Tapering BZRAs improves cessation rates compared with usual care without serious harms . Patients might be more amenable to deprescribing conversations if they underst and the rationale ( potential for harm ) , are involved in developing the tapering plan , and are offered behavioural advice .

MS2_dynamic_1_shot60

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Elevated plasma total homocysteine concentration may be a risk factor for cognitive decline and Alzheimer disease , but data from prospect i ve studies are limited . Further , high homocysteine levels are associated with low vitamin status , and it is unknown whether it is homocysteine toxicity or vitamin insufficiency that is responsible for the observed cognitive dysfunction . METHODS We performed cross-sectional and longitudinal analyses of a cohort of 499 high-functioning community-dwelling persons aged 70 to 79 years to determine the effect of homocysteine and related vitamin plasma concentrations on cognitive function and cognitive decline . Nonfasting plasma concentrations of homocysteine , folate , vitamin B(6 ) , and vitamin B(12 ) were measured at baseline . Summary measures of cognitive function were created from tests of multiple cognitive domains administered at baseline and again after 7 years . RESULTS In cross-sectional analyses investigating each variable separately , subjects with elevated homocysteine levels , or low levels of folate or vitamin B(6 ) , demonstrated worse baseline cognitive function . In longitudinal analyses , after adjusting for multiple covariates , including homocysteine , those in the bottom quartile of folate had a 1.6-fold increased risk ( 95 % confidence interval : 1.01 to 2.31 ; P = 0.04 ) of being in the worst quartile of 7-year cognitive decline . Low folate levels largely accounted for a trend towards greater cognitive decline with elevated homocysteine level . CONCLUSION In high-functioning older adults , low folate levels appear to be a risk factor for cognitive decline . The risk of developing cognitive decline might be reduced through dietary folate intake Based on research demonstrating associations between folate , B-12 and B-6 vitamins and cognition and mood , we investigated the effects of short-term supplementation in 211 healthy younger , middle-aged and older women who took either 750 microg of folate , 15 microg of vitamin B-12 , 75 mg of vitamin B-6 or a placebo daily for 35 d. In addition , we examined associations between dietary intake of these vitamins and cognition and mood . Usual dietary intake status was estimated using a retrospective , self-report , quantified food frequency question naire . Participants completed alternate forms of st and ardized tests of cognitive processing re sources , memory , executive function , verbal ability and self-report mood measures before and after supplementation . Supplementation had a significant positive effect on some measures of memory performance only , and no effect on mood . Dietary intake status was associated with speed of processing , recall and recognition and verbal ability BACKGROUND Deficiencies of vitamin B-12 , folic acid , and vitamin B-6-as defined by laboratory measures -occur in 10 - 20 % of elderly subjects . The clinical significance remains unresolved . OBJECTIVE The objective was to explore any association between vitamin status and vitamin treatment and movement and cognitive performance in elderly subjects . DESIGN Community-dwelling subjects ( n = 209 ) with a median age of 76 y were r and omly assigned to daily oral treatment with 0.5 mg cyanocobalamin , 0.8 mg folic acid , and 3 mg vitamin B-6 or placebo ( double blind ) for 4 mo . Movement and cognitive performance tests were performed before and after treatment . RESULTS A high plasma total homocysteine ( tHcy ) concentration ( > or = 16 micromol/L ) was found in 64 % of men and in 45 % of women , and a high serum methylmalonic acid ( MMA ) concentration ( > or = 0.34 micromol/L ) was found in 11 % of both sexes . Movement time , digit symbol , and block design ( adjusted for age , sex , smoking , and creatinine ) correlated independently with plasma tHcy ( P < 0.01 , < 0.05 , and < 0.01 , respectively ) ; the simultaneity index and block design correlated with serum MMA ( P < 0.05 for both ) . Vitamin therapy significantly decreased plasma tHcy ( 32 % ) and serum MMA ( 14 % ) . No improvements were found in the movement or cognitive tests compared with placebo . Neither vitamin therapy nor changes in plasma tHcy , serum MMA , serum vitamin B-12 , plasma folate , or whole-blood folate correlated with changes in movement or cognitive performance . CONCLUSIONS High plasma tHcy and serum MMA were prevalent and correlated inversely with movement and cognitive performance . Oral B vitamin treatment normalized plasma tHcy and serum MMA concentrations but did not affect movement or cognitive performance . This might have been due to irreversible or vitamin-independent neurocognitive decline or to an insufficient dose or duration of vitamins OBJECTIVE To explore the associations of low serum levels of vitamin B(12 ) and folate with AD occurrence . METHODS A population -based longitudinal study in Sweden , the Kungsholmen PROJECT A r and om sample of 370 nondemented persons , aged 75 years and older and not treated with B(12 ) and folate , was followed for 3 years to detect incident AD cases . Two cut-off points were used to define low levels of vitamin B(12 ) ( < or = 150 and < or = 250 pmol/L ) and folate ( < or = 10 and < or = 12 nmol/L ) , and all analyses were performed using both definitions . AD and other types of dementia were diagnosed by specialists according to DSM-III-R criteria . RESULTS When using B(12 ) < or = 150 pmol/L and folate < or = 10 nmol/L to OUTPUT: Association of dietary intake levels of B vitamins with age-related neurodegenerative diseases and cognitive INPUT: BACKGROUND Depression is common and the efficacy of antidepressants is suboptimal . High plasma homocysteine has been consistently associated with depression , and treatment with certain B vitamins demonstrably reduces its concentration . AIMS To determine whether vitamins B6 , B12 and folic acid enhance response to antidepressant treatment over 52 weeks . METHOD R and omised , double-blind , placebo-controlled trial of citalopram ( 20 - 40 g ) together with 0.5 mg of vitamin B12 , 2 mg of folic acid and 25 mg of vitamin B6 for 52 weeks ( Australian and New Zeal and Clinical Trials Registry : 12609000256279 ) . Participants were community-dwelling adults aged 50 years or over with DSM-IV-TR major depression . We measured severity of symptoms with the Montgomery-Åsberg Depression Rating Scale ( MADRS ) . The primary outcome was remission of the depressive episode after 12 , 26 and 52 weeks . Secondary outcomes included reduction of MADRS scores over time and relapse of major depression after recovery by week 12 . Results In total , 153 people were r and omised ( 76 placebo , 77 vitamins ) . Remission of symptoms was achieved by 78.1 and 79.4 % of participants treated with placebo and vitamins by week 12 ( P = 0.840 ) , by 76.5 and 85.3 % at week 26 and 75.8 and 85.5 % at week 52 ( effect of intervention over 52 weeks : odds ratio ( OR ) = 2.49 , 95 % CI 1.12 - 5.51 ) . Group differences in MADRS scores over time were not significant ( P = 0.739 ) . The risk of subsequent relapse among those who had achieved remission of symptoms at week 12 was lower in the vitamins than placebo group ( OR = 0.33 , 95 % CI 0.12 - 0.94 ) . CONCLUSIONS B vitamins did not increase the 12-week efficacy of antidepressant treatment , but enhanced and sustained antidepressant response over 1 year . Replication of these findings would m and ate that treatment guidelines adopt the adjunctive use of B vitamins as a safe and inexpensive strategy to manage major depression in middle-aged and older adults BACKGROUND B-vitamin deficiencies have been associated with depression ; however , there is very little prospect i ve evidence from population -based studies of older adults . OBJECTIVE We examined whether dietary intakes of vitamins B-6 , folate , or vitamin B-12 were predictive of depressive symptoms over an average of 7.2 y in a community-based population of older adults . DESIGN The study sample consisted of 3503 adults from the Chicago Health and Aging project , an ongoing , population -based , biracial ( 59 % African American ) study in adults aged > or = 65 y. Dietary assessment was made by food-frequency question naire . Incident depression was measured by the presence of > or = 4 depressive symptoms from the 10-item version of the Center for Epidemiologic Studies Depression scale . RESULTS The logistic regression models , which used generalized estimating equations , showed that higher total intakes , which included supplementation , of vitamins B-6 and B-12 were associated with a decreased likelihood of incident depression for up to 12 y of follow-up , after adjustment for age , sex , race , education , income , and antidepressant medication use . For example , each 10 additional milligrams of vitamin B-6 and 10 additional micrograms of vitamin B-12 were associated with 2 % lower odds of depressive symptoms per year . There was no association between depressive symptoms and food intakes of these vitamins or folate . These associations remained after adjustment for smoking , alcohol use , widowhood , caregiving status , cognitive function , physical disability , and medical conditions . CONCLUSION Our results support the hypotheses that high total intakes of vitamins B-6 and B-12 are protective of depressive symptoms over time in community-residing older adults BACKGROUND The role of folate , vitamin B(12 ) and homocysteine levels in depression is not clear . AIMS To investigate cross-sectional and prospect i ve associations between folate , B(12 ) and homocysteine levels and late-life depression . METHOD A total of 732 Korean people aged 65 years or over were evaluated at baseline . Of the 631 persons who were not depressed , 521 ( 83 % ) were followed over a period of 2 - 3 years and incident depression was ascertained with the Geriatric Mental State schedule . Serum folate , serum vitamin B(12 ) and plasma homocysteine levels were assayed at both baseline and follow-up . RESULTS Lower levels of folate and vitamin B(12 ) and higher homocysteine levels at baseline were associated with a higher risk of incident depression at follow-up . Incident depression was associated with a decline in vitamin B(12 ) and an increase in homocysteine levels over the follow-up period . CONCLUSIONS Lower folate , lower vitamin B(12 ) and raised homocysteine levels may be risk factors for late-life depression Objectives : 1 ) To compare serum vitamin B12 , C and folate concentrations in a r and omly selected sample of elderly ( age 65 years or older ) male and female Hispanics and nonHispanic whites ( NHW ) and 2 ) to examine associations between serum B12 , C and folate concentrations compared to measures of cognitive and affective ( depression ) functions . Methods : Equal OUTPUT:

Conclusion : Low folate and B12 serum levels seem to be associated with depression in the aged .

MS2_dynamic_1_shot61

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives To evaluate the efficacy and tolerability of once-daily extended release quetiapine fumarate ( quetiapine XR ) monotherapy in patients with major depressive disorder ( MDD ) . Patients and methods This was a 10-week ( 8-week active treatment/2-week post-treatment ) r and omized , double-blind , placebo- and active-controlled study ( D1448C00004 ) . Patients received quetiapine XR 150 mg/day , escitalopram 10 mg/day , or placebo ; patients with an inadequate response ( < 20 % improvement in Montgomery – Åsberg Depression Rating Scale [ MADRS ] total score ) at week two received double-dose treatment . The primary end point was week eight change from r and omization in MADRS total score . Secondary end points included MADRS response ( ≥50 % improvement ) and remission ( score ≤8 ) ; Hamilton Rating Scale for Depression total and item 1 ; Hamilton Rating Scale for Anxiety total , psychic , and somatic ; Clinical Global Impressions – Severity of Illness total ; Pittsburgh Sleep Quality Index ( PSQI ) global ; and Quality of Life Enjoyment and Satisfaction Question naire – Short Form percentage maximum total scores . Tolerability was assessed throughout . Results A total of 471 patients was r and omized . No significant improvements in MADRS total score were observed at week eight ( last observation carried forward ) with either active treatment ( quetiapine XR , −17.21 [ P=0.174 ] ; escitalopram , −16.73 [ P=0.346 ] ) versus placebo ( −15.61 ) . There were no significant differences in secondary end points versus placebo , with the exception of week-eight change in PSQI global score ( quetiapine XR , −4.96 [ P<0.01 ] versus placebo , −3.37 ) . Mixed-model repeated- measures analysis of observed-case data suggested that the primary analysis may not be robust . Most commonly reported adverse events included dry mouth , somnolence , and dizziness for quetiapine XR , and headache and nausea for escitalopram . Conclusion In this study , neither quetiapine XR ( 150/300 mg/day ) nor escitalopram ( 10/20 mg/day ) showed significant separation from placebo . Both compounds have been shown previously to be effective in the treatment of MDD ; possible reasons for this failed study are discussed . Quetiapine XR was generally well tolerated , with a profile similar to that reported previously OBJECTIVE The authors evaluated the efficacy and safety of lurasidone in the treatment of patients with major depressive episodes associated with bipolar I disorder . METHOD Patients were r and omly assigned to receive double-blind treatment with lurasidone ( 20 - 60 mg/day [ N=166 ] or 80 - 120 mg/day [ N=169 ] ) or placebo ( N=170 ) for 6 weeks . Primary and key secondary endpoints were change from baseline to week 6 on the Montgomery-Åsberg Depression Rating Scale ( MADRS ) and depression severity score on the Clinical Global Impressions scale for use in bipolar illness ( CGI-BP ) , respectively . RESULTS Lurasidone treatment significantly reduced mean MADRS total scores at week 6 for both the 20 - 60 mg/day group ( -15.4 ; effect size=0.51 ) and the 80 - 120 mg/day group ( -15.4 ; effect size=0.51 ) compared with placebo ( -10.7 ) . Similarly , lurasidone treatment result ed in significantly greater endpoint reduction in CGI-BP depression severity scores for both the 20 - 60 mg/day group ( -1.8 ; effect size=0.61 ) and the 80 - 120 mg/day group ( -1.7 ; effect size=0.50 ) compared with placebo ( -1.1 ) . Both lurasidone groups also experienced significant improvements compared with placebo in anxiety symptoms and in patient-reported measures of quality of life and functional impairment . Discontinuation rates due to adverse events were similar in the 20 - 60 mg/day ( 6.6 % ) , 80 - 120 mg/day ( 5.9 % ) , and placebo ( 6.5 % ) groups . The most frequent adverse events associated with lurasidone were nausea , headache , akathisia , and somnolence . Minimal changes in weight , lipids , and measures of glycemic control were observed with lurasidone . CONCLUSION Monotherapy with lurasidone in the dosage range of 20 - 120 mg/day significantly reduced depressive symptoms in patients with bipolar I depression . Lurasidone was well tolerated , with few changes in weight or metabolic parameters OBJECTIVE To evaluate aripiprazole once-monthly ( AOM ) , a long-acting injectable suspension of aripiprazole , as acute treatment in patients with schizophrenia ( DSM-IV-TR ) . METHOD Adults experiencing an acute psychotic episode were r and omized to 12 weeks of double-blind treatment with AOM 400 mg or placebo ( October 2012-August 2013 ) . The primary efficacy outcome was change from baseline to endpoint ( week 10 ) in Positive and Negative Syndrome Scale ( PANSS ) total score . The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale ( CGI-S ) score . Secondary efficacy outcomes included change from baseline in PANSS positive and negative subscale and Personal and Social Performance Scale ( PSP ) scores . The study took place from October 2012 through August 2013 . RESULTS OUTPUT: The results support previous findings that weight-gain occurs quickly . INPUT: Background Open-label quetiapine coadministration with SSRI therapy , in a diagnostically mixed sample of comorbid anxiety patients , offered additional anxiolytic benefit . Therefore , we design ed the following controlled trial to confirm these findings in a comorbid , SSRI-resistant , panic disorder ( PD ) patient sample . Methods This was a single-site , double-blind , placebo-controlled ( PLAC ) , r and omized , parallel group ( 2 groups ) , 8-week , quetiapine extended release ( XR ) coadministration trial . SSRI resistance was determined either historically or prospect ively . Patients were r and omized if they remained moderately ill ( CGI-S score ≥ 4 ) . Change in the PDSS scale total score was the primary efficacy outcome measure . Responders were identified as those with a ≥50 % decrease from their baseline PDSS score . In the early weeks of therapy , XR was flexibly and gradually titrated from 50 to 400 mg/day . Results 43 patients were screened in total , and 26 of these were r and omized and evaluable . 21 patients ( 78 % of the r and omized group ) completed the trial ( 10 XR ; 11 PLAC ) . The endpoint quetiapine XR mean daily dose ± SD was 150 ± 106 mg . While , in the sample as a whole , there was improvement in PDSS scores across the 8-week trial ( ANOVA main effect of time , F = 10.9 , df8,192 , p < 0.0001 ) , the treatment × time interaction effect was not statistically significant ( F = 0.8 , df8,192 , p = 0.61 ) . There was no between-group difference in responder frequency at endpoint . Conclusions This proof-of-concept RCT did not support the efficacy of this treatment strategy for SSRI-resistant PD . Quetiapine XR was generally well-tolerated . Important limitations were the small sample size , and the relatively low average dose of quetiapine XR used . Clinical Trials.gov ID # : Abstract This long-term extension of an 8-week r and omized , naturalistic study in patients with panic disorder with or without agoraphobia compared the efficacy and safety of clonazepam ( n = 47 ) and paroxetine ( n = 37 ) over a 3-year total treatment duration . Target doses for all patients were 2 mg/d clonazepam and 40 mg/d paroxetine ( both taken at bedtime ) . This study reports data from the long-term period ( 34 months ) , following the initial 8-week treatment phase . Thus , total treatment duration was 36 months . Patients with a good primary outcome during acute treatment continued monotherapy with clonazepam or paroxetine , but patients with partial primary treatment success were switched to the combination therapy . At initiation of the long-term study , the mean doses of clonazepam and paroxetine were 1.9 ( SD , 0.30 ) and 38.4 ( SD , 3.74 ) mg/d , respectively . These doses were maintained until month 36 ( clonazepam 1.9 [ SD , 0.29 ] mg/d and paroxetine 38.2 [ SD , 3.87 ] mg/d ) . Long-term treatment with clonazepam led to a small but significantly better Clinical Global Impression (CGI)–Improvement rating than treatment with paroxetine ( mean difference : CGI-Severity scale −3.48 vs −3.24 , respectively , P = 0.02 ; CGI-Improvement scale 1.06 vs 1.11 , respectively , P = 0.04 ) . Both treatments similarly reduced the number of panic attacks and severity of anxiety . Patients treated with clonazepam had significantly fewer adverse events than those treated with paroxetine ( 28.9 % vs 70.6 % , P < 0.001 ) . The efficacy of clonazepam and paroxetine for the treatment of panic disorder was maintained over the long-term course . There was a significant advantage with clonazepam over paroxetine with respect to the frequency and nature of adverse events Paroxetine has been shown to be effective in panic disorder in three 10- to 12-week studies . This trial studied the longer term effects of paroxetine in patients with DSM-III-R defined panic disorder . Patients who satisfactorily completed a 12-week , double-blind , placebo-controlled study of paroxetine and clomipramine could choose to continue receiving their r and omized treatment for a further 36 weeks . Efficacy assessment s included the daily panic attack diary , the Clinical Global Impression Scale , the Hamilton Anxiety Rating Scale , the Marks Sheehan Phobia Scale and the Sheehan Disability Scale . In total , 176 patients were included in the intention-to-treat population . The number of full panic attacks decreased in all three groups during the 12-week study , and improvements continued with long-term therapy . Paroxetine was statistically significantly more effective than placebo throughout the long-term study with respect to reduction from baseline of full panic attacks , and at the end of treatment with respect to the proportion of patients who eventually experienced no panic attacks . There were no significant differences between paroxetine and clomipramine . The proportion of patients who withdrew from the study due to adverse effects was greater in the clomipramine group ( 19 % ) than in either the paroxetine group ( 7 % ) or the placebo group ( 9 % ) . Paroxetine was significantly more effective than placebo and as effective as ( but better tolerated than ) clomipramine in the long-term treatment of panic disorder . Not only was efficacy maintained , but continued improvement was also seen , indicating the importance of long-term treatment in patients with panic disorder Non-response to pharm OUTPUT:

Quetiapine extended-release augmentation has not been found to be beneficial , in comparison to placebo , in non-responders to previously recommended pharmacotherapy . In non-responders to cognitive behavioral therapy ( CBT ) , switching to paroxetine/citalopram has been found to be more effective than continuing CBT . Acceptance and commitment therapy ( ACT ) has shown some improvement in patients ’ resistance to previous psychological/pharmacological interventions compared with a waiting-list condition . Prolonged pharmacotherapy may produce significant improvement in patients with unsatisfactory response to short-term pharmacotherapy , while switching to pharmacotherapy may help non-responders to CBT .

MS2_dynamic_1_shot62

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND St and ard chemotherapy for newly diagnosed ovarian cancer is a platinum-taxane combination . The Gynecologic Oncology Group conducted a r and omized , phase 3 trial that compared intravenous paclitaxel plus cisplatin with intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel in patients with stage III ovarian cancer . METHODS We r and omly assigned patients with stage III ovarian carcinoma or primary peritoneal carcinoma with no residual mass greater than 1.0 cm to receive 135 mg of intravenous paclitaxel per square meter of body-surface area over a 24-hour period followed by either 75 mg of intravenous cisplatin per square meter on day 2 ( intravenous-therapy group ) or 100 mg of intraperitoneal cisplatin per square meter on day 2 and 60 mg of intraperitoneal paclitaxel per square meter on day 8 ( intraperitoneal-therapy group ) . Treatment was given every three weeks for six cycles . Quality of life was assessed . RESULTS Of 429 patients who underwent r and omization , 415 were eligible . Grade 3 and 4 pain , fatigue , and hematologic , gastrointestinal , metabolic , and neurologic toxic effects were more common in the intraperitoneal-therapy group than in the intravenous-therapy group ( P < or = 0.001 ) . Only 42 percent of the patients in the intraperitoneal-therapy group completed six cycles of the assigned therapy , but the median duration of progression-free survival in the intravenous-therapy and intraperitoneal-therapy groups was 18.3 and 23.8 months , respectively ( P=0.05 by the log-rank test ) . The median duration of overall survival in the intravenous-therapy and intraperitoneal-therapy groups was 49.7 and 65.6 months , respectively ( P=0.03 by the log-rank test ) . Quality of life was significantly worse in the intraperitoneal-therapy group before cycle 4 and three to six weeks after treatment but not one year after treatment . CONCLUSIONS As compared with intravenous paclitaxel plus cisplatin , intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel improves survival in patients with optimally debulked stage III ovarian cancer BACKGROUND We aim ed to evaluate the in vitro and in vivo effects of poly [ L-lactic acid ] microsphere containing cisplatin ( CDDP-MS ) for intraperitoneal ( i.p . ) chemotherapy for ovarian cancer . METHODS We initially examined the in vitro and in vivo profile of cisplatin release from the CDDP-MS , then this drug delivery system was evaluated in 15 patients . RESULTS The in vitro study showed that cisplatin was released constantly over a 3-week period . Rats in the CDDP-MS group had a significantly lower peak serum concentration of platinum compared with rats in the aqueous cisplatin solution ( CDDP-S ) group ; the serum concentration of platinum showed a gradual decline . The ascitic fluid concentration of platinum also gradually decreased in the CDDP-MS group . We treated 15 patients with recurrent ovarian cancer with CDDP-MS containing 200 mg of cisplatin ( n = 5 ) or CDDP-S containing 100 mg of cisplatin ( n = 10 ) administered i.p . The peak serum and ascites concentrations of platinum were lower immediately after administration of CDDP-MS than after administration of CDDP-S , but increased over time in the CDDP-MS group , reflecting the slow-release effect of CDDP-MS . Grade 1 to 2 leukopenia and /or neutropenia occurred in 2 of 5 patients . No thrombocytopenia or renal or neurologic toxicity was observed ; CONCLUSION These findings indicate that the i.p . administration of CDDP-MS increased the dose intensity of cisplatin and appeared to be safe and effective for the treatment of ovarian cancer Pegylated liposomal doxorubicin is a new formulation with activity against epithelial ovarian carcinoma ( EOC ) . The authors sought to determine patient characteristics that may predict for response to this treatment and favorable time to failure as well as survival BACKGROUND Cisplatin is a highly effective chemotherapeutic agent against epithelial ovarian cancer but is associated with significant toxicities . SPI-77 is a liposomal pegylated formulation of cisplatin that was developed to reduce systemic toxicity and to better deliver cisplatin to tumors . We assessed the response rates and safety of SPI-77 , in patients with recurrent epithelial ovarian cancer . PATIENTS AND METHODS Patients were selected for having previously achieved a platinum treatment free interval of greater than 6 months ( e.g. platinum-sensitive ) and high potential of achieving responses when rechallenged with a platinum drug . SPI-77 was administered at a dose of 260 mg/m(2 ) every 21 days until disease progression . RESULTS Enrollment was terminated after 5 patients were treated because of concern with the adequacy of the formulation . Four out of the five patients had stable disease as best response . While no serious , unexpected adverse events occurred in spite of large cumulative doses of SPI-77 , there were concerns related to the large lipid load and prolonged persistence of residual platinum in body stores . CONCLUSION The results of this study , although inconclusive regarding its primary endpoints , provide some important lessons for the development of similar liposomal platinum agents PURPOSE The purpose of our studies was to define the maximal-tolerated dose OUTPUT: In the majority of the included studies chemotherapeutics entrapped in a DDS significantly improved efficacy over free chemotherapeutics regarding both survival and tumor growth inhibition . Subgroup analyses , however , revealed that cisplatin entrapped in a DDS did not result in additional tumor growth inhibition compared to free cisplatin , although it did result in improved survival . Micelles did not show a significant tumor growth inhibition compared to free chemotherapeutics , which indicates that micelles may not be a suitable DDS for ovarian cancer treatment . Other subgroup analyses , such as targeted versus non-targeted DDS or IV versus IP administration route , did not identify specific characteristics of DDS that affected treatment efficacy . This systematic review shows the potential , but also the limitations of chemotherapy by drug delivery systems for ovarian cancer treatment . INPUT: A hospital-based case-control study of ovarian cancer was conducted in London and Oxford between October 1978 and February 1983 . Menstrual characteristics , reproductive and contraceptive history and history of exposure to various environmental factors were compared between 235 women with histologically diagnosed epithelial ovarian cancer and 451 controls . High gravidity , hysterectomy , female sterilisation and oral contraceptive use were associated with a reduced risk of ovarian cancer . Infertility and late age at menopause were associated with an increase in risk . While these factors were related , they were each found to be independently associated with ovarian cancer risk after adjusting for the effect of the other factors BACKGROUND Ovarian germ cell tumors ( OGCT ) are highly curable when treated with cytoreductive surgery and platinum-based chemotherapy . We evaluated the safety and activity of a 3-day modified bleomycin , etoposide , and cisplatinum ( mBEP ) regimen in patients with OGCT . PATIENTS AND METHODS Patients with FIGO stages I-IV OGCT were treated with three ( stages I-III complete resection ) or four cycles ( incomplete resection or stage IV ) of bleomycin 15 mg iv , etoposide 120 mg/m(2 ) iv , and cisplatin 40 mg/m(2 ) iv for 3 days every 3 weeks . RESULTS Forty-eight patients ( 14 with dysgerminoma and 34 with non-dysgerminomatous tumors ) were included in our study . Most patients had stage I disease ( 65 % ) and complete resection of their tumor ( 67 % ) . Twenty percent of patients developed grade 3 or 4 neutropenia with 4 episodes of neutropenic fever . During follow-up ( median : 5 years ) , two patients developed progressive disease including one patient who died . All patients with stage I or II disease and all patients with dysgerminoma remain free of disease . However , 20 % of patients with non-dysgerminomatous tumors stage III or IV experienced progressive disease . CONCLUSION The modified 3-day BEP regimen was safe and effective in patients with OGCT . Further improvements are needed for patients with advanced , suboptimally debulked non-dysgerminomatous tumors OBJECTIVES The objectives were to describe the clinical characteristics and prognosis of surgically treated patients with stage II and III serous borderline tumors of the ovary with noninvasive implants . MATERIAL S AND METHODS From 1990 to 2000 , 16 patients with stage II and III ovarian serous borderline tumors and noninvasive implants were diagnosed and prospect ively followed at our center . All patients underwent surgical treatment including staging and their pathology was review ed . Fifteen patients had thorough surgical staging by laparotomy , while one patient was staged laparoscopically . No patient was treated with adjuvant therapy ( radiation or chemotherapy ) after surgical treatment and none were lost to follow-up . RESULTS The mean age at diagnosis was 42 years ( range 26 - 59 ) . Fourteen patients were treated by abdominal hysterectomy , bilateral salpingo-oophorectomy , omentectomy , and multiple peritoneal biopsies , while 2 patients were treated conservatively for fertility preservation . Two patients underwent pelvic and para-aortic lymph node dissection . Fifteen of 16 patients had ovarian surface involvement with tumor . All patients but 2 had clinical evidence of extraovarian disease at the time of surgery . The mean duration of follow-up was 60.7 months ( range 2 - 134 months ) . Thirteen patients ( 81 % ) are alive without evidence of disease . Four patients ( 25 % ) required subsequent surgery for recurrent disease and all are still alive . Two patients have been treated with chemotherapy ( paclitaxel/carboplatin ) for progressive borderline disease , while an additional patient was treated after first relapse with chemotherapy for an invasive recurrence . CONCLUSIONS Carefully staged patients with advanced serous borderline tumors of the ovary and noninvasive implants have a good prognosis without adjuvant therapy PURPOSE This r and omized , multicenter , phase III noninferiority trial was design ed to test the efficacy and safety of the combination of pegylated liposomal doxorubicin ( PLD ) with carboplatin ( CD ) compared with st and ard carboplatin and paclitaxel ( CP ) in patients with platinum-sensitive relapsed/recurrent ovarian cancer ( ROC ) . PATIENTS AND METHODS Patients with histologically proven ovarian cancer with recurrence more than 6 months after first- or second-line platinum and taxane-based therapies were r and omly assigned by stratified blocks to CD ( carboplatin area under the curve [ AUC ] 5 plus PLD 30 mg/m(2 ) ) every 4 weeks or CP ( carboplatin AUC 5 plus paclitaxel 175 mg/m(2 ) ) every 3 weeks for at least 6 cycles . Primary end point was progression-free survival ( PFS ) ; secondary end points were toxicity , quality of life , and overall survival . RESULTS Overall 976 patients were recruited . With median follow-up of 22 months , PFS for the CD arm was statistically superior to the CP arm ( hazard ratio , 0.821 ; 95 % CI , 0.72 to 0.94 ; P = .005 ) ; median PFS was 11.3 versus 9.4 months , respectively . Although overall survival data are immature for final analysis , we report here a total of 334 deaths . Overall severe nonhematologic toxicity ( 36.8 % v 28.4 % ; P < .0 OUTPUT:

In regards to surgery it is recommended to perform total omentectomy since subclinic metastasis have been documented in 10 - 30 % of all cases , and systematic limphadenectomy , necessary to be able to obtain an adequate surgical staging . Minimal invasion surgery is not a recommended procedure for the treatment of advanced ovarian cancer . Radiotherapy can be used to palliate symptoms . In the present , there is not a st and ardized screening method . Diagnosis in early stages means a better survival . Radiotherapy can be indicated to palliate symptoms

MS2_dynamic_1_shot63

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: In this multicentre , prospect i ve , r and omized , open-label , blinded-endpoint ( PROBE ) study , the efficacy of 12 weeks ' treatment with once-daily telmisartan 40–80 mg and enalapril 10–20 mg was evaluated using ambulatory blood pressure monitoring ( ABPM ) in 522 patients with mild-to-moderate essential hypertension . Patients were titrated to the higher dose of study drug at week 6 if mean seated diastolic blood pressure ( DBP ) was ≥ 90 mmHg . The primary endpoint was the change from baseline in ambulatory DBP in the last 6 h of the 24-h dosing interval after 12 weeks ' treatment . Telmisartan and enalapril produced similar reductions from baseline in DBP and systolic blood pressure ( SBP ) over all ABPM periods evaluated ( last 6 h , 24-h , daytime and night-time ) . Telmisartan produced a significantly greater reduction in mean seated trough DBP , measured unblinded with an automated ABPM device in the clinic , amounting to a difference of −2.02 mmHg ( P < 0.01 ) . A significantly greater proportion of patients achieved a seated diastolic response with telmisartan than enalapril ( 59 % versus 50 % ; P < 0.05 ) , also measured with the same ABPM device . Both treatments were well tolerated . Compared with telmisartan , enalapril was associated with a higher incidence of cough ( 8.9 % versus 0.8 % ) and hypotension ( 3.9 % versus 1.1 % ) . Therefore , telmisartan may provide better long-term compliance and , consequently , better blood pressure control than enalapril BACKGROUND Blood pressure ( BP ) has a circadian pattern with a morning surge that is associated with an increased risk of acute coronary and cerebrovascular events . In a prospect i ve , r and omized , open-label , blinded-endpoint , parallel-group , multicenter , forced-titration study of telmisartan and ramipril , the efficacy of both drugs on mean ambulatory diastolic BP ( DBP ) and systolic BP ( SBP ) during the last 6 h of a 24-h dosing interval was evaluated . METHODS After screening and a single-blind run-in phase , 812 adults with mild-to-moderate hypertension ( defined as a mean seated DBP > or = 95 mm Hg and < or = 109 mm Hg and a 24-h ABPM mean DBP 7 > or = 85 mm Hg ) were r and omized to the open-label , 14-week , forced-titration , active-treatment phase as follows : telmisartan 40 mg/80 mg/80 mg ( n = 405 ) or ramipril 2.5 mg/5 mg/10 mg ( n = 407 ) , once daily in the morning . The primary efficacy variable was change from baseline in the last 6-h mean DBP and SBP at 8 and 14 weeks as assessed by ambulatory BP monitoring ( ABPM ) . Secondary efficacy variables were changes from baseline in BP control during each of the 24-h periods and in-clinic trough cuff BP . RESULTS Telmisartan 80 mg was superior to ramipril 5 mg and 10 mg in change from baseline in the last 6-h ABPM mean DBP and SBP at both 8 and 14 weeks ( both P < .0001 ) , respectively . At 14 weeks , the adjusted mean change from baseline in DBP for telmisartan 80 mg was -8.8 mm Hg compared with that for ramipril 10 mg of -5.4 mm Hg ( P < .0001 ) . For SBP , the adjusted mean change from baseline for telmisartan 80 mg was -12.7 mm Hg compared with that for ramipril 10 mg of -7.9 mm Hg ( P < .0001 ) . At 14 weeks , telmisartan 80 mg also yielded superior reductions from baseline in trough cuff BP compared with ramipril 10 mg ( DBP : -11.0 mm Hg v -7.8 mm Hg , respectively ; SBP : -14.3 mm Hg v -9.1 mm Hg , respectively ; both P < .0001 ) . Measures of 24-h BP control favored telmisartan 80 mg versus ramipril 10 mg ( P < .0001 ) , as did other secondary ABPM endpoints during the daytime , night-time , and morning periods . Treatment-related adverse events were uncommon ; patients treated with ramipril had a higher incidence of cough than those treated with telmisartan ( 10.1 % v 1.5 % , respectively ) . CONCLUSIONS Telmisartan 80 mg was consistently more effective than ramipril 10 mg in reducing both DBP and SBP during the last 6 h of the dosing interval , a measure of the early morning period when patients are at greatest risk of life-threatening cardiovascular and cerebrovascular events . Telmisartan 80 mg was also more effective than ramipril 10 mg in reducing BP throughout the entire 24-h dosing interval . Both drugs were well tolerated BACKGROUND This study compared the effects of losartan and perindopril on plasma plasminogen activator inhibitor-1 ( PAI-1 ) and fibrinogen in hypertensive type 2 diabetic patients . METHODS We studied 85 nonsmoking out patients , aged 46 to 64 years , with mild to moderate essential hypertension ( diastolic blood pressure [ OUTPUT: Contribution This systematic review of trials that directly compared ACE inhibitors and ARBs in adults with essential hypertension found good evidence that the agents had similar long-term effects on blood pressure . There were no consistent differential effects for mortality , cardiovascular events , progression to diabetes , left ventricular function , or kidney disease . Cough was more frequent with ACE inhibitors than ARBs . Implication Both ACE inhibitors and ARBs have similar effects on blood pressure and may not have differential effects on other clinical outcomes , although ACE inhibitors do cause cough more often than ARBs . For example , ACE inhibitors do not entirely block production of angiotensin II because of other , unaffected converting enzymes . INPUT: Fourteen patients with mild to moderate essential hypertension were r and omized , after a baseline placebo period of 4 weeks , to receive the angiotensin converting enzyme ( ACE ) inhibitor quinapril or a placebo . During a 12 week , double-blind phase , the dosage of quinapril was increased from 10 to 40 mg twice daily being doubled every 4 weeks . At the end of the baseline period and of each month of the double-blind phase , 12 h overnight urine collection s were made and morning blood sample s were taken about 12 h after the last dose of medication . During the double-blind phase , blood pressure in the quinapril group ( n = 7 ) decreased from 159 ± 3/105 ± 1 to 141 ± 6/94 ± 2 mm Hg ( mean ± SEM ) . Serum ACE activity and plasma angiotensin II concentration were reduced to 4 ± 1 % and 14 ± 1 % of the pretreatment values , respectively . Neither the plasma concentrations nor the urinary excretions of prostagl and in E2 , 6-keto-prostagl and in F1α ( a prostacyclin metabolite ) , or thromboxane B2 ( a metabolite of thromboxane A2 ) were affected by quinapril . In the placebo group , blood pressure tended to decline but the biochemical variables remained essentially unchanged . These results indicate that prostanoids are not involved in the antihypertensive action of quinapril , the principal effect of which seems to be inhibition of the renin-angiotensin system Summary The presence of slightly increased urinary albumin excretion ( UAE ) , even at levels well below levels detectable by an ordinary dipstick , has been suggested as a predictor of cardiovascular morbidity and as a reflection of the degree of overall vascular permeability . The aim of the present investigation was to study the effects of two different antihypertensive drug regimens , an ACE inhibitor and aβ-adrenoceptor antagonist , on the low UAE rate observed in subjects with uncomplicated , mild to moderate primary hypertension . After a 4-week placebo run-in period , 49 patients ( mean age 54 y ) were r and omly assigned in a double blind manner either to further 4 weeks on placebo ( P , n = 15 ) , 8 weeks on lisinopril ( L , n = 17 ; 20 mg/40 mg o. d. ) or 8 weeks on atenolol ( A , n = 17 ; 50 mg/100 mg o. d. ) . The 24-h UAE was measured every second week . At entry and after 4 weeks the glomerular filtration rate and the renal plasma flow were measured . Both drugs lowered blood pressure ( BP ) to a similar extent after 4 and 8 weeks of treatment ; the blood pressures were 160/106 ( P ) , 159/104 ( L ) and 154/103 ( A ) at entry , and 133/83 ( L ) and 134/87 ( A ) at the end of the study after 8 weeks . On entry the 24-h UAE in all patients ranged from 4 to 49 mg ( mean 14.1 mg ) , and it did not differ significantly between groups . After 4 weeks the UAE during 24 h was reduced by approximately one third in the lisinopril-treated group , and by 10 % in the atenolol reated group , whereas it remained unaltered in the group on placebo . After 8 weeks the 24-hour UAE was approximately 20 % lower compared to baseline levels in the lisinopril-treated patients . In the atenolol-treated group the UAE was unaltered compared to baseline . However , none of the changes in the UAE was statistically significant , nor were there any statistically significant differences between the two antihypertensive regimens . Moreover , there were no significant effect of the lisinopril or atenolol treatment on renal function or on renal haemodynamics . It is concluded that in patients with uncomplicated , mild to moderate hypertension both an ACE-inhibitor , such as lisinopril , as well as aβ1-selective adrenoceptor blocking agent , such as In a double-blind , parallel-group study , 260 patients with mild to severe essential hypertension were r and omized to treatment with placebo or spirapril at 6 , 12 or 24 mg once daily for 6 weeks . When blood pressures were measured at the end of the dosing interval ( trough ) , all spirapril regimens had produced similar reductions in sitting systolic and diastolic blood pressures ( siSBP/siDBP ) which were significantly greater than those observed in placebo-treated patients . There were no relevant changes in resting heart rate in any of the study groups . At the study endpoint , the mean reductions in siSBP/siDBP were 14.9/11.5 mmHg with spirapril at 6 mg , 15.4/12.0 mmHg with spirapril at 12 mg and 17.8/12.4 mmHg with spirapril at 24 mg/day vs. 3.1/3.6 mmHg with placebo . In a subgroup of 122 patients , blood pressure was recorded at the end of the dosing interval and during the 8 hours immediately postdose to monitor the peak effects on blood pressure . All spirapril dosages produced similar reductions at peak with a mean decrease of siDBP of approximately 20 mmHg in comparison to baseline values vs 6 - 7 mmHg with placebo . The trough : peak ratios for 6 , 12 and 24 mg all lay between 60 % and 90 % for siSBP and siDBP , indicating that most of the peak effect was maintained at trough . Spirapril was OUTPUT:

The data do not suggest that any one ACE inhibitor is better or worse at lowering BP . ACE inhibitor doses above Max did not significantly lower BP more than Max . There are no clinical ly meaningful BP lowering differences between different ACE inhibitors .

MS2_dynamic_1_shot64

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: CONTEXT The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously in a r and omized trial setting . OBJECTIVE To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of 16 608 postmenopausal women , who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 ( average follow-up , 5.6 years ) . INTERVENTION One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOME MEASURE Incident invasive cancer of the ovary and endometrium . RESULTS In 5.6 years of follow-up , there were 32 cases of invasive ovarian cancer , 58 cases of endometrial cancer , 1 case of nonendometrial uterine cancer , 13 cases of cervical cancer , and 7 cases of other gynecologic cancers . The hazard ratio ( HR ) for invasive ovarian cancer in women assigned to estrogen plus progestin compared with placebo was 1.58 ( 95 % confidence interval [ CI ] , 0.77 - 3.24 ) . The HR for endometrial cancer was 0.81 ( 95 % CI , 0.48 - 1.36 ) . No appreciable differences were found in the distributions of tumor histology , stage , or grade for either cancer site . The incidence of other gynecologic cancers was low and did not differ by r and omization assignment . More women taking estrogen plus progestin required endometrial biopsies ( 33 % vs 6 % ; P<.001 ) . CONCLUSIONS This r and omized trial suggests that continuous combined estrogen plus progestin therapy may increase the risk of ovarian cancer while producing endometrial cancer rates similar to placebo . The increased burden of endometrial biopsies required to assess vaginal bleeding further limits the acceptability of this regimen . These data provide additional support for caution in the use of continuous combined hormones CONTEXT The timing of initiation of hormone therapy may influence its effect on cardiovascular disease . OBJECTIVE To explore whether the effects of hormone therapy on risk of cardiovascular disease vary by age or years since menopause began . DESIGN , SETTING , AND PARTICIPANTS Secondary analysis of the Women 's Health Initiative ( WHI ) r and omized controlled trials of hormone therapy in which 10,739 postmenopausal women who had undergone a hysterectomy were r and omized to conjugated equine estrogens ( CEE ) or placebo and 16,608 postmenopausal women who had not had a hysterectomy were r and omized to CEE plus medroxyprogesterone acetate ( CEE + MPA ) or placebo . Women aged 50 to 79 years were recruited to the study from 40 US clinical centers between September 1993 and October 1998 . MAIN OUTCOME MEASURES Statistical test for trend of the effect of hormone therapy on coronary heart disease ( CHD ) and stroke across categories of age and years since menopause in the combined trials . RESULTS In the combined trials , there were 396 cases of CHD and 327 cases of stroke in the hormone therapy group vs 370 [ corrected ] cases of CHD and 239 cases of stroke in the placebo group . For women with less than 10 years since menopause began , the hazard ratio ( HR ) for CHD was 0.76 ( 95 % confidence interval [ CI ] , 0.50 - 1.16 ) ; 10 to 19 years , 1.10 ( 95 % CI , 0.84 - 1.45 ) ; and 20 or more years , 1.28 ( 95 % CI , 1.03 - 1.58 ) ( P for trend = .02 ) . The estimated absolute excess risk for CHD for women within 10 years of menopause was -6 per 10,000 person-years ; for women 10 to 19 years since menopause began , 4 per 10,000 person-years ; and for women 20 or more years from menopause onset , 17 per 10,000 person-years . For the age group of 50 to 59 years , the HR for CHD was 0.93 ( 95 % CI , 0.65 - 1.33 ) and the absolute excess risk was -2 per 10,000 person-years ; 60 to 69 years , 0.98 ( 95 % CI , 0.79 - 1.21 ) and -1 per 10,000 person-years ; and 70 to 79 years , 1.26 ( 95 % CI , 1.00 - 1.59 ) and 19 per 10,000 person-years ( P for trend = .16 ) . Hormone therapy increased the risk of stroke ( HR , 1.32 ; 95 % CI , 1.12 - 1.56 ) . Risk did not vary significantly by age or time since menopause . There was a nonsignificant tendency for the effects of hormone therapy on total mortality to be more favorable in younger than older women ( HR of 0.70 for 50 - 59 years ; 1.05 for 60 - 69 years , and 1 OUTPUT: Hormone replacement therapy may slightly improve overall survival in women who have undergone surgical treatment for EOC , but the certainty of the evidence is low . There may be little or no effect of HRT use on progression-free survival . Future well- design ed RCTs are required as this is an important area to women experiencing menopausal symptoms following surgical treatment for ovarian cancer , especially as doctors are often reluctant to prescribe HRT in this scenario . The evidence in this review is too limited to support or refute that HRT is very harmful in this population INPUT: Currently raloxifene , a selective estrogen receptor modulator , is being investigated as a potential alternative for postmenopausal hormone replacement to prevent osteoporosis and cardiovascular disease . We compared the 2-year effects of raloxifene on a wide range of cardiovascular risk factors with those of placebo and conjugated equine estrogens ( CEEs ) . Analyses were based on 56 hysterectomized but otherwise healthy postmenopausal women aged 54 . 8+/-3.5 ( mean+/-SD ) years who entered this double-blind study and who were r and omly assigned to raloxifene hydrochloride 60 mg/d ( n=15 ) or 150 mg/d ( n=13 ) , placebo ( n=13 ) , or CEEs 0.625 mg/d ( n=15 ) . At baseline and after 6 , 12 , and 24 months of treatment , we assessed serum lipids , blood pressure , glucose metabolism , C-reactive protein , and various hemostatic parameters . Compared with placebo , both raloxifene and CEEs lowered the level of low density lipoprotein cholesterol by 0.53 to 0.79 mmol/L ( all P<0.04 ) and lowered , at 24 months , the level of fibrinogen by 0.71 to 0.86 g/L ( all P<0.05 ) . The effects of raloxifene and CEEs did not differ significantly . In contrast to raloxifene , from 6 months on CEEs increased high density lipoprotein cholesterol by 0.25 to 0.29 mmol/L and reduced plasminogen activator inhibitor-1 antigen by 30.6 to 48.6 ng/mL ( all P<0.02 versus both placebo and raloxifene ) . CEEs transiently increased C-reactive protein by 1.0 mg/L at 6 months ( P<0.05 versus placebo ) and prothrombin-derived fragment F1 + 2 by 0 . 79 nmol/L at 12 months ( P<0.001 versus placebo ) . Finally , from 12 months on , CEEs increased triglycerides by 0.33 to 0.56 mmol/L ( all P<0.05 versus both placebo and raloxifene ) . Our findings suggest that in healthy postmenopausal women , raloxifene and estrogen monotherapy have similar beneficial effects on low density lipoprotein cholesterol and fibrinogen levels . These treatments differ , however , in their effects on high density lipoprotein cholesterol , triglycerides , and plasminogen activator inhibitor-1 and possibly in their effects on prothrombin fragment F1 + 2 and C-reactive protein CONTEXT The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously in a r and omized trial setting . OBJECTIVE To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial of 16 608 postmenopausal women , who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 ( average follow-up , 5.6 years ) . INTERVENTION One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate ( n = 8506 ) or placebo ( n = 8102 ) . MAIN OUTCOME MEASURE Incident invasive cancer of the ovary and endometrium . RESULTS In 5.6 years of follow-up , there were 32 cases of invasive ovarian cancer , 58 cases of endometrial cancer , 1 case of nonendometrial uterine cancer , 13 cases of cervical cancer , and 7 cases of other gynecologic cancers . The hazard ratio ( HR ) for invasive ovarian cancer in women assigned to estrogen plus progestin compared with placebo was 1.58 ( 95 % confidence interval [ CI ] , 0.77 - 3.24 ) . The HR for endometrial cancer was 0.81 ( 95 % CI , 0.48 - 1.36 ) . No appreciable differences were found in the distributions of tumor histology , stage , or grade for either cancer site . The incidence of other gynecologic cancers was low and did not differ by r and omization assignment . More women taking estrogen plus progestin required endometrial biopsies ( 33 % vs 6 % ; P<.001 ) . CONCLUSIONS This r and omized trial suggests that continuous combined estrogen plus progestin therapy may increase the risk of ovarian cancer while producing endometrial cancer rates similar to placebo . The increased burden of endometrial biopsies required to assess vaginal bleeding further limits the acceptability of this regimen . These data provide additional support for caution in the use of continuous combined hormones Background — The Women ’s Health Initiative ( WHI ) Estrogen Alone trial assessed the balance of benefits and risks of hormone use in healthy postmenopausal women . The trial was stopped prematurely because there was no benefit for coronary heart disease and an increased risk of stroke . This report provides a thorough analysis of the stroke finding using the final results from the completed trial data base . Methods and Results — The WHI Estrogen Alone hormone trial is a multicenter , double-blind , placebo-controlled , r and omized clinical trial in 10 739 women aged 50 to 79 years who were given daily conjugated equine estrogen ( CEE ; 0.625 OUTPUT:

Women taking HT had a significantly decreased incidence of fracture with long-term use . Research ers found no strong evidence that HT has a clinical ly meaningful impact on the incidence of colorectal cancer . AUTHORS ' CONCLUSIONS : Women with intolerable menopausal symptoms may wish to weigh the benefits of symptom relief against the small absolute risk of harm arising from short-term use of low-dose HT , provided they do not have specific contraindications . HT may be unsuitable for some women , including those at increased risk of cardiovascular disease , increased risk of thromboembolic disease ( such as those with obesity or a history of venous thrombosis ) or increased risk of some types of cancer ( such as breast cancer , in women with a uterus ) . The risk of endometrial cancer among women with a uterus taking oestrogen-only HT is well documented . HT is not indicated for primary or secondary prevention of cardiovascular disease or dementia , nor for prevention of deterioration of cognitive function in postmenopausal women . Although HT is considered effective for the prevention of postmenopausal osteoporosis , it is generally recommended as an option only for women at significant risk for whom non-oestrogen therapies are unsuitable .

MS2_dynamic_1_shot65

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Antral biopsy specimens from 89 consecutive patients with nonulcer dyspepsia and erosive prepyloric changes included in a prospect i ve , r and omized , double-blind 4-wk study of the effect of an aluminum-magnesium antacid ( 120 mmol/day ) or pirenzepine ( 50 mg b.i.d . ) vs. placebo were examined histologically . Campylobacter pylori ( CP ) was found by light microscopy of silver-stained sections in 25 patients ( 28 % ) . Campylobacter pylori-positive patients were on average older than CP-negative patients ( p = 0.02 ) . There was a strong association between CP colonization and acute inflammation ( p less than 0.001 ) , both being rare in the absence of chronic inflammation . During treatment with antacids , the density of CP decreased ( p less than 0.001 ) without any improvement of the inflammatory reaction . On the contrary , the number of patients with gastritis tended to increase after antacids as compared with placebo ( p less than 0.10 ) . A separate analysis showed no symptomatic effect of the drugs . Thus , neither nonulcer dyspepsia nor erosive prepyloric changes are strongly associated with antral CP colonization or acute inflammation . Aluminum-magnesium antacids may suppress antral CP infection without healing the gastritis or relieving symptoms The aim of this study was to determine the effect of colloidal bismuth subcitrate ( De Nol ) on symptoms and gastric histology in patients with non-ulcer dyspepsia . In a single centre trial , patients with food related upper abdominal pain not caused by ulcer disease were r and omised to receive one tablet of colloidal bismuth subcitrate or matching placebo four times daily for eight weeks . Seventy three patients were entered and 51 completed the trial : 28 patients in the colloidal bismuth subcitrate group and 23 in the placebo group . Overall there was no difference between the two groups in terms of symptom relief . Among patients with histological gastritis ( n = 23 ) , however , those who took colloidal bismuth subcitrate used fewer antacid tablets ( for three of four fortnightly periods ) and were more likely to become asymptomatic ( eight of 11 v three of 12 , p less than 0.05 ) ; their gastritis was more likely to resolve ( five of 10 v 0 of 12 , p less than 0.025 ) and their gastric biopsies more likely to become negative for Helicobacter like organisms ( eight of nine v 0 of 12 , p less than 0.001 ) when compared with patients taking placebo . In contrast , patients who did not have gastritis in their index biopsies ( n = 28 ) fared similarly whether they received colloidal bismuth subcitrate or placebo . Our results indicate that the administration of colloidal bismuth subcitrate benefited non-ulcer dyspepsia patients with gastritis but had no effect on those without Duodenal biopsy specimens from 471 adults and 47 children were examined to determine the prevalence and distribution of gastric epithelium in the duodenal bulb in relation to age , gender , gastroduodenal inflammation , smoking , alcohol and consumption of nonsteroidal anti-inflammatory drugs ( NSAID ) . Gastric metaplasia was present in the anterior wall duodenal biopsy specimen in 31 % , was significantly less common in patients under 17 than in adults , and was more common in males than females . In sixty two adults who underwent multiple radial duodenal biopsy gastric metaplasia was r and omly distributed around the duodenal circumference ; sixty three per cent of the patients with gastric metaplasia found on multiple biopsy were detected by just the anterior biopsy . Gastric metaplasia was not obviously associated with alcohol , cigarette , or NSAID consumption . While the presence of gastric metaplasia was associated with adulthood , male sex , and low fasting gastric juice pH , its extent was associated with active duodenitis and Helicobacter-associated gastritis . On logistic regression , gastric metaplasia in the duodenum and gastric Helicobacter pylori were independent predictors of active duodenitis , but were not significantly associated with inactive duodenal inflammation . H pylori was observed in duodenal biopsy specimens from 32 patients , all with active duodenitis ; bacteria were present only on foci of gastric metaplasia , and were more likely to be seen when the metaplasia was extensive . It is proposed that inflammatory injury to the duodenal mucosa by H pylori may stimulate the development of further gastric metaplasia , and that the area of duodenum susceptible to colonisation with H pylori may therefore increase progressively until mucosal integrity is compromised and ulceration supervenes BACKGROUND The efficacy of anti-Helicobacter pylori treatment and cytoprotective drugs in H. pylori-positive and -negative non-ulcer dyspepsia ( NUD ) , respectively , is debatable . METHODS In a r and omized study , the efficacy of anti-H. pylori treatment versus sucralphate was tested in patients with NUD . One hundred and twelve patients with NUD , 62 positive and 50 negative for H. pylori were studied . Of 62 patients positive for H. pylori , 32 were treated with triple therapy ( colloidal bismuth subcitrate , tetracycline and metronidazole ) for 2 weeks and the remaining 30 were treated with sucralphate ( 1 g , q.i.d . ) for 4 weeks . Of 50 patients negative for H. pylori , 25 each were treated with either sucralphate ( 1 g , q OUTPUT: These trials were smaller and had a shorter follow-up but suggested H pylori eradication was more effective than either H2 receptor antagonists or sucralfate in treating non-ulcer dyspepsia . H pylori eradication therapy has a small but statistically significant effect in H pylori positive non-ulcer dyspepsia . INPUT: The aim of this study was to determine the effect of colloidal bismuth subcitrate ( De Nol ) on symptoms and gastric histology in patients with non-ulcer dyspepsia . In a single centre trial , patients with food related upper abdominal pain not caused by ulcer disease were r and omised to receive one tablet of colloidal bismuth subcitrate or matching placebo four times daily for eight weeks . Seventy three patients were entered and 51 completed the trial : 28 patients in the colloidal bismuth subcitrate group and 23 in the placebo group . Overall there was no difference between the two groups in terms of symptom relief . Among patients with histological gastritis ( n = 23 ) , however , those who took colloidal bismuth subcitrate used fewer antacid tablets ( for three of four fortnightly periods ) and were more likely to become asymptomatic ( eight of 11 v three of 12 , p less than 0.05 ) ; their gastritis was more likely to resolve ( five of 10 v 0 of 12 , p less than 0.025 ) and their gastric biopsies more likely to become negative for Helicobacter like organisms ( eight of nine v 0 of 12 , p less than 0.001 ) when compared with patients taking placebo . In contrast , patients who did not have gastritis in their index biopsies ( n = 28 ) fared similarly whether they received colloidal bismuth subcitrate or placebo . Our results indicate that the administration of colloidal bismuth subcitrate benefited non-ulcer dyspepsia patients with gastritis but had no effect on those without Background —Helicobacter pylori is a human pathogen that colonises the gastric mucosa and causes permanent gastric inflammation . Aims —To assess the symptoms of H pylori infection in an adult unselected population . Subjects — A r and om sample of 3589 adult Danes who were examined in 1982 and 1987 ( n=2987 ) . Methods —Abdominal symptoms within the preceding year were recorded at both attendances . Circulating IgG antibodies against H pylori in serum sample s drawn in 1982 were measured by using in-house indirect enzyme linked immunosorbent assays ( ELISA ) . Results —People with increased levels of IgG antibodies to H pylori were more likely than uninfected individuals to report heartburn ( odds ratio ( OR ) = 1.26 , 95 % confidence interval ( CI ) 1.03–1.54 ) and abdominal pain characterised by daily length ( OR = 1.33 , 95 % CI 0.92–1.91 ) , nocturnal occurrence ( OR = 1.62 , 95 % CI 1.19–2.19 ) , spring aggravation ( OR = 1.68 , 95 % CI 0.70–4.05 ) , and no relation to meals ( OR = 0.62 , 95 % CI 0.43–0.91 ) or stress ( OR = 0.69 , 95 % CI 0.50–0.95 ) . The inclusion of people with increased levels of IgG antibodies to H pylori , but without upper dyspepsia , at study entry significantly increased the likelihood of reporting upper dyspepsia at follow up ( OR = 1.71 , 95 % CI 1.24–2.36 ) . People with epigastric pain and increased levels of IgM antibodies to H pylori only indicative of acute H pylori infection were more likely to report nocturnal pain , heartburn , nausea , and vomiting . Conclusions —H pylori infection may precede the development of dyspepsia and is associated with a variety of gastrointestinal symptoms in people with no history of peptic ulcer disease This r and omised double blind placebo controlled study evaluated the effectiveness of colloidal bismuth subcitrate ( CBS ) , ampicillin and their combination in the treatment of Helicobacter Pylori in non-ulcer dyspepsia ( NUD ) and assessed if elimination of this organism is associated with improvement of gastritis and the symptoms . Forty-eight NUD patients with H. pylori and histologic gastritis were r and omly allocated to one of the three regimens for 28 days . Symptoms were assessed before and after treatment . Forty-three patients completed the trial . Repeat endoscopy within 48 hours of completing treatment showed suppression of H. pylori in 6 of 7 patients ( 85.7 % ) on combined therapy and one of 8 patients ( 12.5 % ) on CBS therapy ( p = 0.0205 ) . There was no suppression of the bacteria in patients treated with ampicillin . Repeat endoscopy performed 2 weeks after completing treatment showed suppression of H. pylori in 3 of 7 patients ( 42.9 % ) on combined therapy and none in the other two groups . Patients on combined therapy who had suppression of H. pylori , 48 hours or 2 weeks after completing treatment were noted to have historical improvement of their gastritis ( p = 0.0001 and p = 0.05 respectively ) . This was also associated with improvement of symptoms in these patients The aim of this study was to assess the effect of colloidal bismuth subcitrate ( CBS ) and metronidazole on Helicobacter pylori eradication and on the course of symptoms due to functional dyspepsia . Forty-one patients with functional dyspepsia were entered into the study and r and omized to treatment with CBS ( 120 mg four times a day ) for four weeks combined with metronidazole ( 250 mg four times a day ) for one week ( group A , N=21 ) or matching placebo ( group B , N=20 ) . The severity of gastritis and of bacterial colonization and the symptom OUTPUT:

Reports of strong associations in small observational studies without appropriate adjustment for potential confounding factors were not generally confirmed by larger and better- design ed studies . The available evidence indicates that there is no strong association between H pylori and dyspepsia , but there is insufficient evidence to confirm or refute the existence of a modest association

MS2_dynamic_1_shot66

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The purpose of this study was to evaluate the outcomes of patients undergoing subpectoral biceps tenodesis for bicipital tendonitis with a superior labral anterior-posterior ( SLAP ) tear . Patients undergoing primary subpectoral biceps tenodesis for arthroscopically confirmed SLAP tears with signs or findings of bicipital tendonitis were included . An independent observer collected data prospect ively as part of a data repository , which was then analyzed retrospectively . Primary outcome measures were the American Shoulder and Elbow Surgeons ( ASES ) score and pain relief via visual analog scale ( VAS ) . Secondary outcome measures included the Simple Shoulder Test ( SST ) , Constant , Single Assessment Numeric Evaluation ( SANE ) , and Short Form 12 ( SF-12 ) scores . Twenty-eight patients with a mean±SD age of 43.7±13.4 years and a mean±SD follow-up of 2.0±1.0 years met inclusion criteria . Workers ' compensation was involved with 43 % of cases , and 46 % of the included patients were manual laborers . Eight ( 32 % ) patients were athletes , and 88 % of the athletes were overhead athletes . Intraoperatively , 15 ( 54 % ) patients had type I SLAP tears , 10 ( 36 % ) had type II SLAP tears , 1 ( 3 % ) had a type III SLAP tear , and 2 ( 7 % ) had type IV SLAP tears . Significant improvements were seen in the following outcome measures pre- vs postoperatively : ASES score ( 58±23 vs 89±18 ; P=.001 ) , SST score ( 6.3±3.6 vs 10.6±3.3 ; P=.001 ) , SANE score ( 54±24 vs 88±25 ; P=.003 ) , VAS score ( 3.8±2.0 vs 1.1±1.8 ; P=.001 ) , SF-12 overall score ( 35±6 vs 42±6 ; P=.001 ) , and SF-12 physical component score ( 39±6 vs 50±10 ; P=.001 ) . Overall satisfaction was excellent in 80 % of patients . Subpectoral biceps tenodesis demonstrates excellent clinical outcomes in select patients with SLAP tears . [ Orthopedics . 2015 ; 38(1):e48-e53 . ] Background Labral repair and biceps tenodesis are routine operations for superior labrum anterior posterior ( SLAP ) lesion of the shoulder , but evidence of their efficacy is lacking . We evaluated the effect of labral repair , biceps tenodesis and sham surgery on SLAP lesions . Methods A double-blind , sham-controlled trial was conducted with 118 surgical c and i date s ( mean age 40 years ) , with patient history , clinical symptoms and MRI arthrography indicating an isolated type II SLAP lesion . Patients were r and omly assigned to either labral repair ( n=40 ) , biceps tenodesis ( n=39 ) or sham surgery ( n=39 ) if arthroscopy revealed an isolated SLAP II lesion . Primary outcomes at 6 and 24 months were clinical Rowe score ranging from 0 to 100 ( best possible ) and Western Ontario Shoulder Instability Index ( WOSI ) ranging from 0 ( best possible ) to 2100 . Secondary outcomes were Oxford Instability Shoulder Score , change in main symptoms , EuroQol ( EQ-5D and EQ-VAS ) , patient satisfaction and complications . Results There were no significant between-group differences at any follow-up in any outcome . Between-group differences in Rowe scores at 2 years were : biceps tenodesis versus labral repair : 1.0 ( 95 % CI −5.4 to 7.4 ) , p=0.76 ; biceps tenodesis versus sham surgery : 1.6 ( 95 % CI −5.0 to 8.1 ) , p=0.64 ; and labral repair versus sham surgery : 0.6 ( 95 % CI −5.9 to 7.0 ) , p=0.86 . Similar results —no differences between groups — were found for WOSI scores . Postoperative stiffness occurred in five patients after labral repair and in four patients after tenodesis . Conclusion Neither labral repair nor biceps tenodesis had any significant clinical benefit over sham surgery for patients with SLAP II lesions in the population studied . Trial registration number Clinical Trials.gov identifier : This study compared arthroscopic biceps tenodesis with biceps repair for isolated type II superior labrum anterior and posterior ( SLAP ) lesions in patients older than 35 years . The authors identified isolated type II SLAP lesions that were surgically managed over a 5-year period . Minimum 2-year follow-up data were available for 22 patients who underwent biceps repair ( repair group ) and for 15 patients who underwent a primary biceps tenodesis ( tenodesis group ) . Mean age at surgery was 45.2±5.5 years in the repair group and 52.0±8.0 years in the tenodesis group . In the repair group , functional outcome improved from baseline to final follow-up using the American Shoulder and Elbow Surgeons ( ASES ) ( 47.5 to 87.4 , respectively ; P<.0001 ) and University of California , Los Angeles ( UCLA ) scores ( 18.5 to 31.2 , respectively ; P<.0001 ) . In the tenodesis group , similar findings were observed for the ASES ( 43.4 to 89.9 , respectively ; P<.0001 ) and UCLA scores ( 19.0 to 32.7 , respectively ; P<.0001 ) . No difference was found in functional outcome between the groups . Full range of motion recovery was delayed by approximately 3 months in the repair group compared with the tenodesis group OUTPUT: The pooled results of UCLA score , SST score , and complications showed that the differences were not statistically significant between the two interventions . The difference of ASES score and satisfaction rate was statistically significant between arthroscopic repair and biceps tenotomy and tenodesis intervention , and arthroscopic biceps tenotomy and tenodesis treatment was more effective . Conclusions Both arthroscopic repair and biceps tenotomy and tenodesis interventions had benefits in type II SLAP lesions . Arthroscopic biceps tenotomy and tenodesis treatment provides better clinical outcome in ASES score and satisfaction rate and comparable complications compared with arthroscopic repair treatment . INPUT: Purpose To evaluate a new clinical test , the resisted supination external rotation test , for the diagnosis of superior labral anterior posterior lesions of the shoulder . Study Design Cohort study ( diagnosis ) ; Level of evidence , 2 . Methods Forty athletes ( average age , 23.9 years ) with activity-related shoulder pain were enrolled in the study . The patients underwent 3 different tests design ed specifically to detect superior labral anterior posterior lesions ( the resisted supination external rotation test , the crank test , and the active compression test ) ; the tests were performed in a r and om order on the affected shoulder . The results of the tests were compared with arthroscopic findings . Results Out of 40 athletes , 29 ( 72.5 % ) had superior labral anterior posterior tears . The resisted supination external rotation test had the highest sensitivity ( 82.8 % ) , specificity ( 81.8 % ) , positive predictive value ( 92.3 % ) , negative predictive value ( 64.3 % ) , and diagnostic accuracy ( 82.5 % ) of all tests performed . Conclusion By re-creating the peel-back mechanism , the resisted supination external rotation test is more accurate than 2 other commonly used physical examination tests design ed to diagnose superior labral anterior posterior tears in overhead-throwing athletes . By using this test in the context of a thorough clinical history and physical examination , lesions of the superior labrum can be more reliably diagnosed BACKGROUND Chronic refractory spinal pain poses a peculiar diagnostic challenge because of multiple putative pain sources , overlapping clinical features , and nonspecific radiologic findings . Diagnostic injection techniques are employed to isolate the source ( s ) of pain . Facet or zygapophysial joint pain is an example of spinal pain diagnosed by local anesthetic injections of the facet joint or its nerve supply . Diagnostic facet joint injections are expected to meet the cardinal features of a diagnostic test ( i.e. , accuracy , safety and reproducibility ) . Accuracy must be compared with a " gold " or criterion st and ard that can confirm presence or absence of a disease . There is , however , no available gold st and ard , such as biopsy , to measure presence or absence of pain . Hence , there is a degree of uncertainty concerning the accuracy of diagnostic facet joint injections . OBJECTIVES To evaluate accuracy , safety and reproducibility of facet or zygapophysial joint injections in diagnosing chronic spinal pain of facet joint origin . STUDY DESIGN A systematic review of the literature for clinical studies on efficacy and utility of facet joint/nerve injections in diagnosing spinal pain from facet joints . METHODS Relevant literature on diagnostic facet injections was identified through data base search es . Excluded were abstract s , review s , book chapters , case reports and studies based on single blocks or blocks without radiologic control . Prospect i ve studies with placebo control , or controlled comparative local anesthetic blocks , were given priority over retrospective studies . Each study was grade d using AHRQ and QUADAS criteria . The level of evidence was classified as conclusive , strong , moderate , limited , or inconclusive . RESULTS Available literature pointed to strong evidence for controlled comparative local anesthetic facet joint medial branch blocks in the diagnosis of neck and low back pain . There was moderate evidence in the diagnosis of pain arising from thoracic facet joints . CONCLUSION The evidence obtained from literature review suggests that controlled comparative local anesthetic blocks of facet joint nerves ( medial branch or dorsal ramus ) are reproducible , reasonably accurate , and safe . The sensitivity , specificity , false-positive rates , and predictive values of these diagnostic tests for neck and low back pain have been vali date d and reproduced in multiple studies We describe the biceps load test for evaluating the integrity of the superior glenoid labrum in shoulders with recurrent anterior dislocations . With the shoulder in an abducted , externally rotated position and the forearm supinated , active flexion of the elbow against resistance relieves the discomfort of a st and ard apprehension test for anterior shoulder instability . A group of 75 patients with proven unilateral anterior shoulder dislocations were prospect ively examined in a double-blind fashion with arthroscopic examination and the biceps load test . Sixty-three patients had a negative test and 62 of these had an intact biceps tendon-superior labrum complex ; the remaining patient had a type II superior labral anterior and posterior lesion . Twelve patients had positive tests , and 10 had superior labral lesions ; the other 2 patients had intact superior labra . Therefore , the biceps load test revealed a sensitivity of 90.9 % , a specificity of 96.9 % , a positive predictive value of 83 % , a negative predictive value of 98 % , and a kappa coefficient of 0.846 Background Tears of the superior labrum of the shoulder , anterior to posterior , are difficult to diagnose clinical ly . Purpose We examined whether the crank or O'Brien tests were reliable tools for detecting glenoid labral tears . Study Design Nonr and omized prospect i ve study . Methods Results of diagnostic shoulder arthroscopy were compared with those of the preoperative tests and magnetic resonance imaging for 65 patients who had symptoms of shoulder pain . Results The crank test result was positive in 29 patients ( 45 % ) , and the O'Brien test was positive in 41 patients ( 63 % ) . The crank test had a positive predictive value of 41 % , was 56 % specific , 46 % sensitive , and had a negative predictive value of 61 % . The O'Brien test had a positive predictive value of 34 % , was 31 % specific , 54 % sensitive , and had a negative predictive value of 50 % . Magnetic resonance imaging had a positive predictive value of 63 % , was 92 % specific , 42 % sensitive , and had a negative predictive value of 83 % . Conclusions The O'Brien and crank tests were not sensitive clinical indicators for OUTPUT:

No tests for impingement or acromioclavicular ( AC ) joint pathology demonstrated significant diagnostic accuracy . Based on pooled data , the diagnostic accuracy of the Neer test for impingement , the Hawkins-Kennedy test for impingement and the Speed test for labral pathology is limited . Currently , almost without exception , there is a lack of clarity with regard to whether common OSTs used in clinical examination are useful in differentially diagnosing pathologies of the shoulder

MS2_dynamic_1_shot67

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain 512 Background : Obesity is an adverse prognostic factor in early BC . We conducted a r and omized clinical trial ( RCT ) to evaluate a 2-year , central ly delivered , telephone-based weight loss intervention ( WLI ) compared to a mailed educational intervention ( EI ) on recurrence , weight loss and QOL in postmenopausal women receiving adjuvant Letrozole . The trial was terminated after 338 of a planned 2,150 women were enrolled due to loss of funding . METHODS 338 women with stage I-IIIa BC were r and omized to WLI ( n%171 ) or EI alone ( n%167 ) at 20 centers in Canada and USA . Eligibility included BMI ≥24 kg/m2 and <3 years of definitive surgery . WLI involved 19 calls , mailings and a participant manual . Weight loss goal was 10 % of baseline via reduction of caloric and fat intake ( 500 - 1000 kcal/day , 20 % calories fat ) and increased physical activity ( 150 - 200 minutes/week ) . RESULTS Mean age and BMI were 61 years and 31.3 kg/m2 . Baseline BMI , adjuvant chemotherapy , and tumor characteristics were balanced between arms . 87.5 % of protocol m and ated WLI calls took place . Mean weight change is shown in the table . Results were similar for baseline BMI ≥/<30 kg/m2 and adjuvant chemotherapy ( yes/no ) . Mean SF 36 normalized physical component score was improved in WLI vs. EI at 6 ( + 4.1 WLI vs. + 2.1 C , p%0.046 ) and 12 months ( + 3.9 WLI vs. + 2.7 EI , p%0.33 ) . CONCLUSIONS A 2-year , telephone-based WLI result ed in significant weight loss at 6 , 12 , and 18 months in early BC . Results were similar with BMI < 30 or 30 + and with or without adjuvant chemotherapy . Follow-up continues to evaluate longer term effects . Funded by Novartis Pharmaceuticals Inc. Sponsored by the Ontario Clinical Oncology Group . [ Table : see text ] A continuing challenge in weight loss treatment is attaining maintenance of weight loss . The goal of this study was to develop a counseling method that would assist African American breast cancer survivors with weight loss maintenance . In this pilot study , 31 obese breast cancer survivors were recruited . Individualized , dietitian-led counseling by telephone and free Weight Watchers coupons were provided to all participants for 18 months . At the 6-month time point , women were r and omized to receive spirituality counseling or not in addition to the st and ard program . The spirituality counseling was delivered via telephone using an 8-step framework . Subjects were asked to utilize daily meditation or prayer , daily readings , and the recording of thoughts in a journal . Mean weight loss from baseline to 6 months was a modest 2.0 % of baseline weight . From 6 to 18 months , there was no further weight change in the spirituality arm and a gain of 0.7 % in the dietitian-only arm . Despite little effect on weight loss , it did appear that spirituality counseling positively affected spiritual well-being ( FACIT-Sp ) scores and dietary quality . The spirituality counseling framework therefore may be further refined and useful for other health promotion studies with African American population Excess body weight at diagnosis and weight gain after breast cancer are associated OUTPUT: The studies included in this review suggest that weight loss is feasible to achieve and is safe in women following treatment for breast cancer . INPUT: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain Background The SenseWear ™ Armb and ( SWA ) ( BodyMedia , Inc. Pittsburgh , PA ) is a physical activity and lifestyle monitor that objective ly and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake . The real-time feedback of the SWA can improve individual self-monitoring and , therefore , enhance weight loss outcomes . Methods We recruited 197 sedentary overweight or obese adults ( age , 46.8 ± 10.8 y ; body mass index ( BMI ) , 33.3 ± 5.2 kg/m2 ; 81 % women , 32 % African-American ) from the greater Columbia , South Carolina area . Participants were r and omized into 1 of 4 groups , a self-directed weight loss program via an evidence -based weight loss manual ( St and ard Care , n = 50 ) , a group-based behavioral weight loss program ( GWL , n = 49 ) , the armb and alone ( SWA-alone , n = 49 ) , or the GWL plus the armb and ( GWL+SWA , n = 49 ) , during the 9-month intervention . The primary outcome was change in body weight and waist circumference . A mixed-model repeated- measures analysis compared change in the intervention groups to the st and ard care group on weight and waist circumference status after adjusting for age , sex , race , education , energy expenditure , and recruitment wave . Results Body weight was available for 62 % of participants at 9 months ( 52 % st and ard care , 70 % intervention ) . There was significant weight loss in all 3 intervention groups ( GWL , 1.86 kg , P = 0.05 ; SWA-alone , 3.55 kg , P = 0.0002 ; GWL+SWA , 6.59 kg , P < 0.0001 ) but not in the St and ard Care group ( 0.89 kg , P = 0.39 ) at month 9 . Only the GWL+SWA group achieved significant weight loss at month 9 compared to the St and ard Care group ( P = 0.04 ) . Significant waist circumference reductions were achieved in all 4 groups at month 9 ( St and ard Care , 3.49 cm , P = 0.0004 ; GWL , 2.42 cm , P = 0.008 ; SWA-alone , 3.59 cm , P < 0.0001 ; GWL+SWA , 6.77 cm , P < 0.0001 ) , but no intervention group had significantly reduced waist circumference compared to the St and ard Care group . Conclusions Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults . This strategy , combined with a group-based behavioral intervention , may yield optimal weight loss . Trial Registration Clinical Trials.gov : CONTEXT Rapid increases in access to the Internet have made it a viable mode for public health intervention . No controlled studies have evaluated this re source for weight loss . OBJECTIVE To determine whether a structured Internet behavioral weight loss program produces greater initial weight loss and changes in waist circumference than a weight loss education Web site . DESIGN R and omized , controlled trial conducted from April to December 1999 . SETTING AND PARTICIPANTS Ninety-one healthy , overweight adult hospital employees aged 18 to 60 years with a body mass index of 25 to 36 kg/m OUTPUT:

Conclusion These studies provide preliminary evidence suggesting that EAMS can increase physical activity and decrease weight significantly , but their efficacy compared to other interventions has not yet been demonstrated .

MS2_dynamic_1_shot68

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The aim of this study was to investigate the effect of connective tissue massage in the treatment of individuals with fibromyalgia . The results of this r and om study of 48 individuals diagnosed with fibromyalgia ( 23 in the treatment group and 25 in the reference group ) show that a series of 15 treatments with connective tissue massage conveys a pain relieving effect of 37 % , reduces depression and the use of analgesics , and positively effects quality of life . The treatment effects appeared gradually during the 10-week treatment period . Three months after the treatment period about 30 % of the pain relieving effect was gone , and 6 months after the treatment period pain was back to about 90 % of the basic value . As long as there is a lack of effective medical treatment for individuals with fibromyalgia , they ought to be offered treatments with connective tissue massage . However , further studies are needed in the mechanisms behind the treatment effects . Copyright 1999 European Federation of Chapters of the International Association for the Study of Pain Background Massage is increasingly used to manage chronic pain but its benefit has not been clearly established . The aim of the study is to determine the effectiveness of a single session of nurse-administered massage for the short term relief of chronic non-malignant pain and anxiety . Methods A r and omised controlled trial design was used , in which the patients were assigned to a massage or control group . The massage group received a 15 minute manual massage and the control group a 15 minute visit to talk about their pain . Adult patients attending a pain relief unit with a diagnosis of chronic pain whose pain was described as moderate or severe were eligible for the study . An observer blind to the patients ' treatment group carried out assessment s immediately before ( baseline ) , after treatment and 1 , 2 , 3 and 4 hours later . Pain was assessed using 100 mm visual analogue scale and the McGill Pain Question naire . Pain Relief was assessed using a five point verbal rating scale . Anxiety was assessed with the Spielberger short form State-Trait Anxiety Inventory . Results 101 patients were r and omised and evaluated , 50 in the massage and 51 in the control group . There were no statistically significant differences between the groups at baseline interview . Patients in the massage but not the control group had significantly less pain compared to baseline immediately after and one hour post treatment . 95 % confidence interval for the difference in mean pain reduction at one hour post treatment between the massage and control groups is 5.47 mm to 24.70 mm . Patients in the massage but not the control group had a statistically significant reduction in anxiety compared to baseline immediately after and at 1 hour post treatment . Conclusion Massage is effective in the short term for chronic pain of moderate to severe intensity . Trial Registration [ IS RCT N98406653 To evaluate the impact of music on opioid requirements and pain levels during renal lithotripsy using alfentanil patient-controlled analgesia ( PCA ) , we conducted a prospect i ve , blinded , r and omized controlled trial . Patients undergoing lithotripsy were instructed in PCA use and asked to rate their anxiety and select their preferred type of music . They were then premedicated with morphine and ketorolac and r and omly allocated into two groups . Group 1 ( n = 97 ) had music started 10 min before the procedure and maintained until 10 min after its conclusion . Group 2 ( n = 96 ) had music begun at the conclusion of lithotripsy and continued for 10 min . Pain intensity , alfentanil requirement , side effects , quality of analgesia , patient satisfaction , and acceptance of the technique were evaluated . Demographics , alfentanil requirement , pain levels , side effects , quality of analgesia , and patient satisfaction were similar in both groups . The addition of music did not provide any benefit . This result raises the possibility that some nonpharmacologic therapies have minimal impact in setting s where the painful stimulus is moderate to severe and adequate pharmacotherapy is available Objective To determine the effectiveness of lessons in the Alex and er technique , massage therapy , and advice from a doctor to take exercise ( exercise prescription ) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain . Design Factorial r and omised trial . Setting 64 general practice s in Engl and . Participants 579 patients with chronic or recurrent low back pain ; 144 were r and omised to normal care , 147 to massage , 144 to six Alex and er technique lessons , and 144 to 24 Alex and er technique lessons ; half of each of these groups were r and omised to exercise prescription . Interventions Normal care ( control ) , six sessions of massage , six or 24 lessons on the Alex and er technique , and prescription for exercise from a doctor with nurse delivered behavioural counselling . Main outcome measures Rol and Morris disability score ( number of activities impaired by pain ) and number of days in pain . Results Exercise and lessons in the Alex and er technique , but not massage , remained effective at one year ( compared with control Rol and disability score 8.1 : massage −0.58 , 95 % confidence interval −1.94 to 0.77 , six lessons −1.40 , −2.77 to −0.03 , 24 lessons −3.4 , −4.76 to −2.03 , and exercise −1.29 , −2.25 to −0.34 ) . Exercise after six lessons achieved 72 % of the effect of 24 lessons alone ( Rol and disability score −2.98 and −4.14 , respectively ) . Number of days with back pain in the past four weeks was lower after lessons ( compared with control median 21 days : 24 lessons −18 , six lessons −10 , massage −7 ) and quality of life improved significantly . No significant harms were reported . Conclusions One to one lessons in the Alex and er technique from registered teachers have long term benefits for patients with chronic back pain . Six lessons followed by exercise OUTPUT: IMPLICATION S FOR PRACTICE Listening to music , a cognitive-behavioural treatment programme , magnetic therapy , sensorial stimulation , a psychoeducation programme and guided imagery are nursing interventions that helps to reduce the chronic pain in adults and may be used as contributory to the pharmacological treatment . Short exercises for increasing endurance does not reduce pain . INPUT: OBJECTIVES To study the effect of a combination of thalassotherapy , exercise and patient education in people with fibromyalgia . METHODS Patients with fibromyalgia , selected from a rheumatology out-patient department and from members of the Dutch fibromyalgia patient association , were pre-r and omized to receive either 2(1/2 ) weeks of treatment in a Tunisian spa resort , including thalassotherapy , supervised exercise and group education ( active treatment ) or treatment as usual ( control treatment ) . Primary outcome measure was health-related quality of life , measured with the R AND -36 question naire . Secondary measures included the Fibromyalgia Impact Question naire , the McGill Pain Question naire , the Beck Depression Inventory , tender point score and a 6-min treadmill walk test . RESULTS Fifty-eight participants receiving the active treatment reported significant improvement on R AND -36 physical and mental component summary scales . For physical health , differences from the 76 controls were statistically significant after 3 months , but not after 6 and 12 months . A similar pattern of temporary improvement was seen in the self-reported secondary measures . Tender point scores and treadmill walk tests improved more after active treatment , but did not reach significant between-group differences , except for walk tests after 12 months . CONCLUSIONS A combination of thalassotherapy , exercise and patient education may temporarily improve fibromyalgia symptoms and health-related quality of life The aim of this study was to investigate the effect of connective tissue massage in the treatment of individuals with fibromyalgia . The results of this r and om study of 48 individuals diagnosed with fibromyalgia ( 23 in the treatment group and 25 in the reference group ) show that a series of 15 treatments with connective tissue massage conveys a pain relieving effect of 37 % , reduces depression and the use of analgesics , and positively effects quality of life . The treatment effects appeared gradually during the 10-week treatment period . Three months after the treatment period about 30 % of the pain relieving effect was gone , and 6 months after the treatment period pain was back to about 90 % of the basic value . As long as there is a lack of effective medical treatment for individuals with fibromyalgia , they ought to be offered treatments with connective tissue massage . However , further studies are needed in the mechanisms behind the treatment effects . Copyright 1999 European Federation of Chapters of the International Association for the Study of Pain OBJECTIVE To determine the prevalence and characteristics of fibromyalgia in the general population . METHODS A r and om sample of 3,006 persons in Wichita , KS , were characterized according to the presence of no pain , non-widespread pain , and widespread pain . A sub sample of 391 persons , including 193 with widespread pain , were examined and interviewed in detail . RESULTS The prevalence of fibromyalgia was 2.0 % ( 95 % confidence interval [ 95 % CI ] 1.4 , 2.7 ) for both sexes , 3.4 % ( 95 % CI 2.3 , 4.6 ) for women , and 0.5 % ( 95 % CI 0.0 , 1.0 ) for men . The prevalence of the syndrome increased with age , with highest values attained between 60 and 79 years ( > 7.0 % in women ) . Demographic , psychological , dolorimetry , and symptom factors were associated with fibromyalgia . CONCLUSION Fibromyalgia is common in the population , and occurs often in older persons . Characteristic features of fibromyalgia -- pain threshold and symptoms -- are similar in community and clinic population s , but overall severity , pain , and functional disability are more severe in the clinic population OBJECTIVE To compare 2 exercise modalities , aerobic fitness training and stretching exercises , in patients with fibromyalgia ( FM ) in relation to function , pain , quality of life , depression , and anxiety , and to correlate the cardiorespiratory fitness gain with symptom improvement . METHODS Seventy-six women with FM between 18 and 60 years old were r and omized to either an aerobic program or stretching program , for 20 weeks . They were evaluated at the beginning of the program and after 10 and 20 weeks in relation to the improvement of aerobic fitness , flexibility , function , Fibromyalgia Impact Question naire ( FIQ ) , Short-form Health Survey ( SF-36 ) , and depression and anxiety levels . Ventilatory anaerobic threshold ( VT ) and maximum oxygen uptake ( VO2max ) were determined by expired gas analyses . RESULTS Aerobic exercise was superior to stretching in relation to VO2 max , VT , function , depression , pain , and the emotional aspects and mental health domains of SF-36 . Patients in the stretching group showed no improvement in depression , " role emotional , " and " mental health . " No association was noted between improvement in aerobic fitness as measured by VT and the improvement of pain , function , or scores in FIQ and SF-36 . CONCLUSION Our results confirm that aerobic exercise is beneficial to patients with FM , but the cardiorespiratory fitness gain is not related to improvement of FM symptoms Objective : To evaluate the efficacy of a treatment programme for patients with fibromyalgia ( FM ) based on self management , using pool exercises and education . Methods : R and omised controlled trial with a 6 month follow up to evaluate an outpatient multidisciplinary programme ; 164 patients with FM were allocated to an immediate 6 week programme ( n = 84 ) or to a waiting list control group ( n = 80 ) . The main outcomes were changes in quality of life , functional consequences , patient satisfaction and pain , using a combination of patient question naires and clinical examinations . The question naires included the Fibromyalgia Impact Question naire ( FIQ ) , Psychological General Well-Being ( PGWB ) index , regional pain score diagrams , and patient satisfaction measures . Results : 61 participants in the treatment group and 68 controls completed the programme and 6 month follow up exam OUTPUT:

Positive outcomes were reported for pain , health-status and tender point count . There is strong evidence for the use of hydrotherapy in the management of FMS

MS2_dynamic_1_shot69

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Background Atrial fibrillation ( AF ) is a common problem after CABG . Prevention with prophylactic drug therapy has had limited success , therefore alternative approaches are required . This study investigated the role of biatrial pacing compared with no pacing on AF incidence after isolated first-time CABG . Methods and Results During surgery , temporary pacing leads were placed in the lateral wall of the right atrium and at the roof of the left atrium in Bachmann ’s bundle to allow bipolar pacing and sensing at each site . After surgery , all patients were connected to an external pacemaker ( Chorum ELA ) that also acted as a Holter monitor . Patients were consecutively r and omized to either 4 days of biatrial pacing at a base rate of 80 bpm or to no pacing ( control group , base rate 30 bpm ) . End points included an episode of AF lasting > 1 hour on pacemaker Holter , clinical ly detected AF , intensive care unit ( ICU ) and hospital stay , and postoperative complications . One hundred thirty patients were r and omized . Biatrial pacing significantly reduced both monitored ( 13.8 % versus 38.5 % , P = 0.001 ) and clinical ( 10.8 % versus 33.8 % , P = 0.002 ) episodes of AF . Median ICU ( 19 versus 24 hours , P = NS ) and mean hospital stay ( 7.7±6.9 versus 9.7±10 , P = NS ) did not significantly change . The number of postoperative complications was lower in the biatrial group ( 13 versus 35 , P = 0.001 ) . Conclusions Biatrial pacing after CABG significantly decreases the incidence of AF . This is associated with reduced postoperative complications and a trend toward reduced ICU and hospital stay OBJECTIVES The purpose of this study was to investigate the efficacy and safety of amiodarone and propafenone in the conversion of chronic atrial fibrillation in a prospect i ve , r and omized , placebo-controlled study . BACKGROUND The effectiveness of amiodarone and propafenone in the treatment of patients with chronic atrial fibrillation has not been adequately studied . METHODS One hundred one patients ( 48 men , mean age 64 + /- 9 years ) with atrial fibrillation lasting > 3 weeks participated in the study . Thirty-four patients received amiodarone ( 300 mg intravenously over 1 h , followed by 20 mg/kg over the next 24 h plus 600 mg orally , in three doses , for 1 week , then 400 mg/day orally , for three weeks ) , 32 received propafenone ( 2 mg/kg intravenously over 15 min , followed by 10 mg/kg over 24 h and then 450 mg/day orally , for one month ) and the remaining 35 served as control subjects . All patients received digoxin and anticoagulant treatment as indicated ( International Normalized Ratio 2 to 3 ) . RESULTS Conversion to sinus rhythm was achieved in 16 ( 47.05 % ) patients who received amiodarone , in 13 ( 40.62 % ) who received propafenone and in none of the control subjects ( p < 0.001 for both groups vs. control subjects ) . Those who converted had smaller atria than those who did not and atrial fibrillation of shorter duration in both the amiodarone and propafenone groups . Treatment was discontinued in one patient of the propafenone group because of significant QRS widening . CONCLUSIONS Amiodarone and propafenone appear to be safe and equally effective in the termination of chronic atrial fibrillation . Left atrial diameter and arrhythmia duration are independent predictors of conversion OBJECTIVE The purpose of this study was to determine the efficacy of atrial pacing in the prevention of atrial fibrillation following cardiovascular surgery . BACKGROUND Although pharmacologic therapy has been used to help prevent postoperative atrial fibrillation , it suffers from limited efficacy and adverse effects . In the nonoperative setting , novel pacing strategies have been shown to reduce recurrences of atrial fibrillation and prolong arrhythmia-free periods in patients with paroxysmal atrial arrhythmias . METHODS A total of 154 patients ( 115 men ; mean age , 65 + /- 10 years ; ejection fraction , 53 + /- 10 % ) undergoing cardiac surgery ( coronary artery bypass surgery , 88.3 % ; aortic valve replacement , 4.5 % ; coronary bypass + aortic valve replacement , 7.1 % ) had right and left atrial epicardial pacing electrodes placed at the time of surgery . Patients were r and omized to either no pacing , right atrial ( RAP ) , left atrial ( LAP ) or biatrial pacing ( BAP ) for 72 h after surgery . Beta-adrenergic blocking agents were administered concurrently to all patients following surgery . RESULTS There was a reduction in the incidence of postoperative atrial fibrillation from 37.5 % in patients receiving no postoperative pacing to 17 % ( p < 0.005 ) in patients assigned to one of the three pacing strategies . The length of hospital stay was reduced by 22 % from 7.8 + /- 3.7 days to 6.1 + /- 2.3 days ( p = 0.003 ) in patients assigned to postoperative atrial pacing . The incidence of atrial fibrillation was lower in each of the paced groups ( RAP , 8 % ; LAP , 20 % ; BAP , 26 % ) compared with patients who did not receive postoperative pacing ( 37.5 % ) . CONCLUSION Postoperative atrial pacing , in conjunction with beta-blockade , OUTPUT: No significant effect on all-cause or cardiovascular mortality was demonstrated . Prophylaxis to prevent atrial fibrillation after cardiac surgery with any of the studied pharmacological or non-pharmacological interventions may be favored because of its reduction in the rate of atrial fibrillation , decrease in the length of stay and cost of hospital treatment and a possible decrease in the rate of stroke . INPUT: BACKGROUND Amiodarone use was associated with an increased need for pacemaker insertion in a retrospective study of patients with atrial fibrillation ( AF ) and prior myocardial infa rct ion . The aims of this study were to determine prospect ively whether amiodarone increases the need for pacemakers in a general population of patients with AF and whether this effect is modified by sex . METHODS The study included 1005 patients with new-onset AF who were enrolled in the Fibrillation Registry Assessing Costs , Therapies , Adverse events , and Lifestyle ( FRACTAL ) . Multivariable Cox regression models , including time-dependent covariates accounting for medication exposure , were used to evaluate the risk of pacemaker insertion associated with amiodarone use . RESULTS Amiodarone use was associated with an increased risk of pacemaker insertion ( hazard ratio [ HR ] , 2.01 ; 95 % confidence interval [ CI ] , 1.08 - 3.76 ) after adjustment for age , sex , atrial flutter , coronary artery disease , heart failure , and hypertension . The effect of amiodarone use was modified by sex , with a significant risk in women but not in men ( HR , 4.69 ; 95 % CI , 1.99 - 11.05 vs HR , 1.05 ; 95 % CI , 0.42 - 2.58 [ P = .02 ] ) . This interaction remained significant after adjustment for weight , body mass index , weight-adjusted amiodarone dose , and use of other antiarrhythmic or rate control drugs . CONCLUSION The risk of bradyarrhythmia requiring pacemaker insertion associated with amiodarone use for AF is significantly greater in women than in men , independent of weight or body mass index Patients with atrial fibrillation ( AF ) report impaired health-related quality of life ( QOL ) . Differences between men and women with AF have not been described and personality attributes such as somatization ( tendency to amplify benign bodily sensations ) may mediate potential gender differences in QOL . Patients with AF ( n = 264 , 59 % men ) who participated in the Canadian Trial of Atrial Fibrillation ( n = 403 ) completed vali date d QOL question naires at baseline , 3 months , and 12 months after antiarrhythmic drug treatment . Women were significantly older than men and a greater proportion had hypertension , but other cardiac variables did not differ between women and men . At baseline , after controlling for significant clinical and demographic factors , women reported worse physical health ( p = 0.002 ) and functional capacity ( p < 0.001 ) , but not mental health or general well-being . Women also had more frequent and severe cardiac symptoms than men ( both p < 0.001 ) . Physical health improved significantly from baseline to 3 months for women ( p = 0.002 ) , but not for men ( p = 0.066 ) . Conversely , mental health improved for men ( p = 0.007 ) , but not for women . Cardiac symptom frequency and severity improved over time for women and men ( all p < 0.001 ) . Tendency to somatize predicted poor QOL , and women had higher scores than men ( p = 0.023 ) . However , after controlling for somatization , women still had worse physical function , functional capacity , and symptom burden than men . Independent of cardiac disease severity and age , women with AF had significantly more impaired QOL than men , specifically on domains related to physical rather than emotional functioning . Personality attributes may have a role in influencing QOL outcomes BACKGROUND AND PURPOSE Nonvalvular atrial fibrillation ( AF ) is a strong , independent risk factor for stroke , but the absolute rate of stroke varies widely among AF patients , importantly influencing the potential benefit of antithrombotic prophylaxis . We explore factors associated with ischemic stroke in AF patients taking aspirin . METHODS We performed multivariate logistic regression analysis of 2012 participants given aspirin alone or in combination with low , inefficacious doses of warfarin in the Stroke Prevention in Atrial Fibrillation I-III trials followed for a mean of 2.0 years , during which 130 ischemic strokes were observed . RESULTS Age ( relative risk [RR]=1.8 per decade , P<0.001 ) , female sex ( RR=1.6 , P=0.01 ) , history of hypertension ( RR=2.0 , P<0.001 ) , systolic blood pressure > 160 mm Hg ( RR=2.3 , P<0.001 ) , and prior stroke or transient ischemic attack ( RR=2.9 , P<0.001 ) were independently associated with increased stroke risk . Regular consumption of > /=14 alcohol-containing drinks per week was associated with reduced stroke risk ( adjusted RR=0.4 , P=0.04 ) . Among SPAF III participants , estrogen hormone replacement therapy was associated with a higher risk of ischemic stroke ( adjusted RR=3.2 , P=0.007 ) . With the use of these variables , a risk stratification scheme for primary prevention separated participants into those with high ( 7.1%/y , 22 % of the cohort ) , moderate ( 2.6%/y , 37 % of the cohort ) , and low ( 0.9%/y , 41 % of the cohort ) rates of stroke . Ischemic strokes in low-risk participants were less often disabling ( P<0.001 ) . CONCLUSIONS Patients with AF who have high and low rates of stroke during treatment with aspirin can be identified . However , validation of our risk stratification scheme is necessary before it can be applied with confidence to clinical management . Postmenopausal estrogen replacement therapy and moderate alcohol consumption may additionally modify the risk of stroke in AF , but these findings require confirmation B OUTPUT:

In brief , female atrial fibrillation patients more commonly present comorbidities , leading to a higher prevalence of persistent atrial fibrillation ; moreover , they refer to hospital care later and with a longer disease history . Atrial fibrillation symptoms relate to low quality of life in female patients ; in fact , atrial fibrillation paroxysm usually presents higher heart rate , leading to preferentially adopt a rate rather than a rhythm-control strategy . Female atrial fibrillation patients present an increased risk of stroke , worsened by the lower oral anticoagulant prescription rate related to the concomitant higher haemorrhagic risk profile . Trans-catheter ablation is under-used in female patients and , on the contrary , they are more commonly affected by anti-arrhythmic drug side effects

MS2_dynamic_1_shot70

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVES The aim of the present study was to investigate the caries-preventive effect of sealants produced with a high-viscosity glass-ionomer with an elevated powder-liquid ratio ( ART ) , of having energy added to this glass-ionomer , and that of glass-carbomer , in comparison to that of resin composite sealants . METHODS The r and omized controlled trial covered 407 children , with a mean age of 8 years . At a school compound three dentists placed sealants in pits and fissures of high caries-risk children . Evaluation by two independent evaluators was conducted after 0.5 , 1 and 2 years . The Kaplan-Meier survival method , ANOVA and t-test were used in analyzing the data . RESULTS 1352 first permanent molars were sealed . 6.6 % of children and 6.8 % of sealants dropped out within 2 years . 27 re-exposed pits and fissures , 20 in occlusal and 7 in smooth surfaces , in 25 children , developed a dentin carious lesion . The cumulative survival of dentin carious lesion-free pits and fissures in the glass-carbomer sealant group was statistically significantly lower ( 97.4 % ) than those in the high-viscosity glass-ionomer with energy supplied ( 99 % ) and the resin-composite ( 98.9 % ) sealant groups . There was no statistically significant difference in the cumulative survival of dentin carious lesion-free pits and fissures , between the high-viscosity glass-ionomer with ( 99 % ) and without ( 98.3 % ) energy supplied sealant groups , after 2 years . SIGNIFICANCE The survival of dentin carious lesion-free pits and fissures was high in all sealant types . More dentin carious lesions were observed in the glass-carbomer sealant group The present study compares visible-light Delton with Duraphat fluoride varnish for the prevention of occlusal caries in permanent first molars . A clinical trial was carried out in three groups of 6 - 8-yr-old schoolchildren : a sealant group ( 100 children ) , in which Delton light-polymerized fissure sealant was applied to permanent first molars ; a varnish group ( 98 children ) , in which Duraphat was applied to permanent first molars ; and a control group ( 116 children ) . Replacement ( sealant ) and reapplication ( varnish ) was carried out every 6 months . Percent effectiveness at 24 months ( percentage of saving from caries taking molars as analysis unit ) for those molars initially healthy and with complete occlusal eruption was analyzed . 272 , 252 and 238 molars met the inclusion criteria in the control , varnish and sealant groups , respectively . Of these , 45.2 % , 28.2 % and 10.5 % developed caries after 24 months . The effectiveness was greater in the sealed molars than in the varnished molars ( 62.7 % ) In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias PURPOSE This study examined the effects of a widely used ( Delton Pit & Fissure Sealant - Light Cure Opaque , DENTSPLY Professional , York , PA ) pit and fissure sealant material on bisphenol A ( BPA ) levels in blood and saliva , among both low and high-dose groups over time . METHODS A convenience sample of 30 adults from the Old Dominion University population were r and omly and evenly divided into 2 independent variable groups : a low-dose group ( 1 occlusal sealant application ) and high-dose group ( 4 occlusal sealant applications ) . A 2 group , time series design was used to examine the presence and concentration of BPA in serum and saliva after sealant placement . Differences comparing low-dose and high-dose groups were examined 1 hour prior ( baseline ) , 1 hour post , 3 hours post and 24 hours after sealant placement , as measured by a direct-competitive BPA Enzyme Linked ImmunoSorbent Assay ( ELISA ) . Hypothesized outcomes were evaluated by applying a parametric , 2 way ANOVA for repeated measures technique to data on the 30 participants ranging in age from 18 to 40 years , and were of mixed gender and ethnicity . RESULTS BPA was detected in the saliva of all participants prior to sealant placement and ranged from 0.07 to 6.00 ng/ml at baseline . Salivary BPA concentration levels peaked over a 3 hour period following sealant placement and returned to baseline levels within 24 hours . BPA was significantly elevated at all post-sealant placement time periods for both the low-dose ( 1 occlusal sealant application ) and high-dose ( OUTPUT: They also concluded that sealants could minimize the progression of non-cavitated occlusal carious lesions ( also referred to as initial lesions ) that receive a sealant . Finally , based on the available limited evidence , the panel was unable to provide specific recommendations on the relative merits of 1 type of sealant material over the others . INPUT: The aim of the present trial was to ( 1 ) compare the caries-preventive effect of glass ionomer sealants , placed according to the atraumatic restorative treatment ( ART ) procedure , with composite resin sealants over time and ( 2 ) investigate the caries-preventive effect after complete disappearance of sealant material . Forty-six boys and 57 girls , mean age 7.8 years , were r and omly divided into two treatment groups in a parallel-group study design . A light-polymerized composite resin sealant material and a high-viscosity glass ionomer were each placed in 180 fully erupted first molars in their respective treatment groups . Evaluation took place annually for 5 years by calibrated examiners . After 5 years , 86 % composite resin and 88 % glass ionomer sealants did not survive . Three categories of re-exposure periods for caries development in pits and fissures after complete loss of sealants were distinguished : 0–1 , 1–2 and 2–3 years . In the 2- to 3-year group , 13 and 3 % of pits and fissures previously sealed with composite resin and glass ionomer , respectively , were diagnosed as having developed a dentine lesion . The relative risks ( 95 % CI ) of dentine lesion development in surfaces sealed with glass ionomer compared to those sealed with composite resin after 3 , 4 and 5 years were 0.22 ( 0.06–0.82 ) , 0.32 ( 0.14–0.73 ) and 0.28 ( 0.13–0.61 ) , respectively . The relative risks of dentine lesion development in pits and fissures previously sealed with glass ionomer compared with composite resin over re-exposure periods of 1–2 and 2–3 years were 0.26 ( 0.14–0.48 ) and 0.25 ( 0.09–0.68 ) , respectively . We conclude that the caries-preventive effect of high-viscosity glass ionomer sealants , placed using the ART procedure , was between 3.1 and 4.5 times higher than that of composite resin sealants after 3–5 years . Furthermore , high-viscosity ( ART ) glass ionomer sealants appear to have a four times higher chance of preventing caries development in re-exposed pits and fissures of occlusal surfaces in first molars than light-cured composite resin sealant material over a 1- to 3-year period . A well- design ed clinical trial using different types of oral health personnel should be implemented to confirm these initial results Four conventional glass-ionomer cements specifically developed for use with the atraumatic restorative treatment ( ART ) technique were compared with a resin-based sealant for marginal and surface dye penetration , material voids , and completeness of enamel fissure penetration . Thirty sound permanent m and ibular molar teeth were r and omly divided into five groups . After delayed placement of the glass-ionomer cement sealants using st and ardized finger pressure , and conventional placement of the resin-based sealant using a dental probe , the teeth were first thermocycled then the crowns immersed in methylene blue dye before being sectioned . There were no statistically significant differences found between any of the five material s , apart from less marginal dye leakage being present for the resin-based sealant than for one of the glass-ionomer cements . The cements , however , showed better fissure penetration than did the sealant . Despite the delayed placement and higher viscosity , all of the glass-ionomer cements showed satisfactory penetration of the enamel fissures and minimal marginal and surface dye penetration , and material voids , when placed using firm finger pressure . The cements could prove to be useful in the dental treatment of apprehensive children OBJECTIVES To measure the microtensile bond strength to ground enamel of different types of material s used as pit and fissure sealants in combination with different substrate conditioners . METHODS From 40 sound extracted molars , eight groups of five teeth were r and omly formed . The experimental groups were : ( 1 ) ( C ) 37 % phosphoric acid/ClinPro Sealant ( 3 M ESPE ) ; ( 2 ) ( G ) 37 % phosphoric acid/Guardian Seal ( Kerr ) ; ( 3 ) ( E/TF ) 37 % phosphoric acid/Excite/Tetric Flow ( Ivoclar-Vivadent ) ( 4 ) ( OS/UF ) 37 % phosphoric acid/One Step (Bisco)/UniFil Flow ( GC ) ; ( 5 ) ( OS/AE ) 37 % phosphoric acid/One Step/AEliteflo ( Bisco ) ; ( 6 ) ( UB/UF ) UniFil Bond/UniFil Flow ( GC ) ; ( 7 ) ( CC/FVII ) GC Cavity Conditioner/Fuji VII ( GC ) ; ( 8) ( CC/FII ) GC Cavity Conditioner/Fuji II LC Improved ( GC ) . On the buccal of each tooth , a 5 mm high build-up was created by incrementally adding layers of the sealing material on the conditioned enamel . By serially cutting the built-up tooth , multiple beam-shaped specimens about 1 mm x 1 mm in cross section were obtained , and loaded in tensile ( 0.5 mm/min ) until failure occurred . RESULTS The bond strengths measured in MPa were : ( C ) 20.41+/-11.79 ; ( G ) 16.02+/-7.99 ; ( E/TF ) 24.06+/-9.67 ; OS/UF 15.63+/-9.00 ; ( OS/AE ) 9.31+/-6.05 ; ( UB/UF ) 4.96+/-3.46 ; ( CC/FVII ) 1.7 OUTPUT:

This study confirms the likelihood that remnants of high-viscosity glass-ionomer sealant material are retained and block the deeper parts of pits and fissures even after the sealant appears to have disappeared clinical ly , exercising their carious lesion preventive effect

MS2_dynamic_1_shot71

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To evaluate the effects of a rehabilitation brace locked in extension for the first week on the recovery of full extension after ACL reconstruction we compared two groups of subjects who underwent ACL bone-patellar tendon-bone reconstruction . The brace was unlocked twice a day for assisted physiotherapy . In Group A , 18 male subjects wore a post-operative brace locked from 0 ° to 90 ° . In Group B , 18 male subjects wore the same post-op brace locked in full extension for the first week . In both groups the brace was unlocked ( 0 ° -120 ° ) at the beginning of the second postoperative week , and then removed at the beginning of the third week . All the subjects followed the same rigorous , accelerated rehabilitation protocol . Each subject was evaluated pre and post-operatively ( at second , fourth and eighth week ) with bubble-level heel height difference ( HHD ) measurements and KT 1000 arthrometric assessment at the fourth postoperative month . Preoperative bubble-level HHD measurements of the two groups were statistically similar ( Group A 0.6 cm , Group B 1 cm ; not significant , n.s . ) . At the fourth week ( Group A 2.2 cm , Group B 0.6 cm ) and eighth week ( Group A 1.6 cm , Group B 0.1 cm ) follow-ups , bubble-level HHD measurements showed that the extension of the operated knees of Group B was significantly greater than in Group A. KT 1000 arthrometric scores showed no difference between the two groups ( Group A 1.8 mm , Group B 1.5 ; n.s . ) PURPOSE To evaluate the effects an anterior cruciate ligament ( ACL ) brace has on various measures of knee proprioception and postural control . METHODS Thirty subjects ( mean age 27 + /- 11 yr ) having undergone unilateral ACL reconstruction were tested with and without wearing their own custom-fit brace on their involved limb . Proprioception was assessed using joint angle replication tests completed on an isokinetic dynamometer . Postural control was assessed using a series of single-limb st and ing balance tests completed on a force platform . The balance tests included : 1 ) st and ing on the stable platform with eyes open , 2 ) st and ing on a foam mat placed over the platform with eyes open , 3 ) st and ing on the platform with eyes closed , and 4 ) st and ing on the platform after l and ing from a maximal single-limb forward hop . RESULTS The brace provided a small but statistically significant improvement in proprioception ( mean reduction in error scores between target and reproduced angles = 0.64 + /- 1.4 degrees , P = 0.02 ) . For the postural control tests , there was a significant brace condition by test situation interaction ( P = 0.02 ) , with the brace providing a small but statistically significant improvement during the test completed on the stable platform with eyes open ( mean reduction in center of pressure path length = 4.2 + /- 8.4 cm , P = 0.02 ) but not during the other more challenging test situations . Additional post hoc analyses indicated that the relationship between knee proprioception and postural control measures were low and not significant ( r = 0.003 to 0.19 , P > 0.32 ) , consistent with the suggestion that changes in knee proprioception can occur in the absence of substantial changes in postural control . Also , st and ing balance tests that challenged the somatosensory contribution to postural control ( i.e. , those completed on foam , or with eyes closed ) were significantly related to single-limb forward hop distances ( r = -0.4 , P < 0.05 ) , whereas performance during the proprioception test was not ( r = 0.1 , P > 0.50 ) . CONCLUSIONS In general , bracing appears to improve performance during tasks characterized by relatively limited somatosensory input but not during tasks characterized by increased somatosenory input . The small magnitude of the improvements , coupled with their apparent lack of carry over to more difficult and functionally relevant tasks , questions the clinical benefit of the present effects of bracing Abstract Despite changes in rehabilitation protocol s , an extension deficit remains an important potential cause of significant morbidity following anterior cruciate ligament ( ACL ) reconstruction . An extension-assisting brace was design ed using a limited motion brace and an elastic strap across a fulcrum on the anterior aspect of the knee joint . The effects of the brace were investigated in 40 patients undergoing primary ACL reconstruction using an autogenous central third patellar tendon graft . The patients were r and omized either to use the brace in the first 6 weeks postoperatively or to undertake the same accelerated rehabilitation programme but without any brace , and they were review ed at 4 months postoperatively . The following data were recorded : passive and active extension and flexion deficits compared with the non-operated limb , KT-1000 assessment of anterior laxity and isometric quadriceps and hamstring strength . There was no difference between the two groups for any of the recorded variables . This was largely attributed to satisfactory tunnel placement and emphasis on the restoration of extension and quadriceps function during the early postoperative rehabilitation The prospect i ve study examined two different postoperative treatments on 46 patients with acute and isolated disruption of the anterior cruciate ligament ( acl ) , who were treated with reconstruction and augmentation using the semitendinosus-tendon . The patients were r and omised and divided into two groups either to use a postoperative brace ( Donjoy Ind. ) set at full extension ( group A ) or to use the same brace set at a flexion of 20 degrees ( group B ) on the first 3 days after surgery . All patients undertook a st and ard " accelerated " rehabilitation protocol and were evaluated after 3 , 6 and 12 months after surgery . The results were as follow : the patients of group A reached the full extension faster than group B without any loss of knee stability . Postoperative extension even led to an earlier return to work and sport activities . The muscle strength side-to OUTPUT: Although some articles in the literature are in favor of the use of a postoperative brace after anterior cruciate ligament ( ACL ) reconstruction , this review found that several systematic review s and other reports on the topic do not support the use of a postoperative brace after ACL reconstruction . There is no scientific evidence so far to support the routine use of a functional knee brace following a successful ACL reconstruction in the postoperative course . Most authors believe that bracing is not necessary . Postoperative bracing after ACL reconstruction does not seem to help with pain , function , rehabilitation , and stability . INPUT: & NA ; This prospect i ve study was performed to investigate whether postoperative alternate flexion and extension splinting ( daily change in position of immobilization by splinting ) was useful in restoring full range of motion ( ROM ) after total knee arthroplasty as compared with continuous passive motion . The alternate flexion and extension splinting group and the continuous passive motion group were each composed of 34 knees . Final ROM was measured at an average of 3.5 years postoperatively . Squatting was possible in 31 knees ( 45.6 % ) of the alternate flexion and extension splinting group . The postoperative ROM of the osteoarthritic knees ( 131.8 ° ± 12.3 ° ) was significantly greater than that of the rheumatoid knees ( 121.9 ° ± 22.4 ° ) ( p < 0.05 ) . The postoperative ROM of the alternate flexion and extension splinting group ( 135.1 ° ± 11.9 ° ) also was significantly greater than that of the continuous passive motion group ( 120.0 ° ± 19.7 ° ) ( p < 0.01 ) . There was no statistically significant relationship between the posterior slope of tibial cutting and the postoperative ROM . It is suggested that alternate flexion and extension splinting is effective in restoring full ROM after total knee arthroplasty PURPOSE This prospect i ve study aim ed to evaluate radiographically , mechanical or hip-knee-ankle ( HKA ) axis in healthy , asymptomatic , Asian ( Indian and Korean ) adults between 20 and 40 years of age to determine the incidence of inherent varus ( mechanical limb alignment of > 3 ° varus ) and the factors influencing it . METHODS Three hundred and eighty-eight lower limbs were evaluated using full length , st and ing hip-to-ankle radiographs in 198 healthy , asymptomatic , Asian ( Indian and Korean ) adults between 20 and 40 years of age to assess the hip-knee-ankle ( HKA ) angle , medial proximal tibial angle ( MPTA ) , femoral bowing and femoral neck-shaft angle to determine the incidence of inherent varus ( mechanical limb alignment of > 3 ° varus ) and the factors influencing it . RESULTS Overall , the mean HKA angle was 177.6 ° ±2.6 ° with 34.5 % of limbs in inherent varus ( mean HKA angle 174.9 ° ±1.8 ° ) . The incidence of inherent varus was significantly higher ( p=0.01 ) in males ( 40 % ) compared to females ( 28 % ) but similar among Indian ( 34 % ) and Korean subjects ( 35 % ) . The hip-knee-ankle ( HKA ) angle showed significant positive correlation ( r=0.82 , p<0.001 ) with only the medial proximal tibial angle ( MPTA ) . CONCLUSIONS Inherent varus alignment of the lower limb is fairly common among asymptomatic , Asian adults . These results raise several pertinent questions regarding the role of inherent varus in the aetiopathogenesis of knee osteoarthritis and in lower limb realignment procedures We present the peak outcome results of the Oxford medial unicompartmental arthroplasty through a minimally invasive surgical incision . This prospect i ve study included 78 Oxford medial unicompartmental knee replacements in 68 patients . At the 2 year review the patients achieved a mean Oxford Knee Score of 38.3 . This was not significantly different to the 2 year results of the phase 2 Oxford knee carried out using a st and ard parapatellar approach when patients achieved a mean OKS of 36.0 . Four unicompartmental knee replacements required revision for unexplained pain , deep infection , aseptic loosening and bearing dislocation . Minimally invasive joint replacement is attractive to both patients and surgeons , but is technically dem and ing with complications inherent to limited access Aims Approved by the Food and Drug Administration in 2004 , the Phase III Oxford Medial Partial Knee is used to treat anteromedial osteoarthritis ( AMOA ) in patients with an intact anterior cruciate ligament . This unicompartmental knee arthroplasty ( UKA ) is relatively new in the United States , and therefore long-term American results are lacking . Patients and Methods This is a single surgeon , retrospective study based on prospect ively collected data , analysing a consecutive series of primary UKAs using the Phase III mobile-bearing Oxford Knee and Phase III instrumentation . Between July 2004 and December 2006 , the senior author ( RHE ) carried out a medial UKA in 173 patients ( 213 knees ) for anteromedial osteoarthritis or avascular necrosis ( AVN ) . A total of 95 patients were men and 78 were women . Their mean age at surgery was 67 years ( 38 to 89 ) and mean body mass index 29.87 kg/m2 ( 17 to 62 ) . The mean follow-up was ten years ( 4 to 11 ) . Results Survivorship of the Oxford UKA at ten years was 88 % , using life table analysis . Implant survivorship at ten years was 95 % . The most common cause for revision was the progression of osteoarthritis in the lateral compartment . The mean knee score element of the American Knee Society Score ( AKSS ) was 50 pre-operatively and increased to 93 post-operatively . The mean AKSS function score was 56 pre-operatively rising to 78 post-operatively Conclusion This ten-year follow-up study of the Oxford UKA undertaken in the United States shows good survivorship and excellent function in a wide selection of patients with AMOA and AVN . Cite OUTPUT:

Conclusions Although total reoperation rates did not differ in the two population s , reoperation for bearing dislocation was more likely to occur in Asian than in Western patients , whereas reoperation for lateral knee OA progression was more likely to occur in Western than in Asian patients after Oxford Phase III UKA .

MS2_dynamic_1_shot72

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Innovations in periradicular surgery for failed treatment of ortho grade root canal disease have been well-documented . We know of no prospect i ve studies that have compared success rates of conventional methods with these presumed advances . In this prospect i ve r and omised trial we compare the use of an ultrasonic retrotip with a microhead bur in the preparation of a retro grade cavity . Outcome was estimated clinical ly by estimation of pain , swelling , and sinus , and radiographically by looking at infill of bone and retro grade root filling 2 weeks and 6 months postoperatively . Both methods used other surgical techniques including microinstruments to place the retro grade root filling . The success rate of the ultrasonic method was higher ( all patients , n=26 ) than that of the microhead method ( n=19 of 21 ) . A larger study with longer follow up is required to consoli date this evidence OBJECTIVE R and omized clinical prospect i ve study to evaluate the application of MTA and IRM as retro grade sealers in surgical endodontics . STUDY DESIGN One hundred single-rooted teeth were surgically treated . After r and omization , MTA or IRM was used as a retrosealer . Radiographs were taken 1 week , 3 months , and 1 year postoperatively . Assessment was performed by 2 independent assessors 1 year after surgery . Both treatment groups were homogeneous in their composition , and clinical features and radiographic findings were classified according to Rud 's classification . RESULTS Complete healing was observed in 64 % of the MTA-treated teeth vs 50 % of the IRM-treated teeth . Incomplete healing was seen in 28 % ( MTA ) vs 36 % ( IRM ) , and unsatisfactory in 6 % ( MTA ) vs 14 % ( IRM ) . Only 1 failure was seen ( MTA ) . No statistically significant differences were found between the 2 retrofilling material s. CONCLUSION As root-end filling material s in this clinical prospect i ve r and omized design on single rooted teeth , MTA and IRM had the same clinical effectiveness This article covers a 4-year study that reports 320 cases in which endodontic surgery was performed for residual apical lesions or lesions that could not be treated in a conventional way . Four groups of 80 teeth each were formed and they were followed up after a 12-month interval . The first group comprised cases treated with a micro bur , retro grade filling and IRM ; the second , cases treated at the apical and radicular portions with a CO2 laser ; the third , cases in which the retro grade cavity was prepared with an ultrasonic device instead of a micro bur ; and the fourth group comprised cases treated in a similar way to the second group , i.e. , cases treated at the apical and radicular portions , but with a CO2 laser instead of a micro bur . After 12 months , the results showed a better prognosis with ultrasonic treatment . Regardless of technique , the CO2 laser did not improve the healing process OBJECTIVE To evaluate the pain experience following root-end resection and filling with Mineral Trioxide Aggregate or Intermediate Restorative Material . STUDY DESIGN Referred adult patients recruited using strict entry criteria were r and omly allocated to receive either material . A st and ardized surgical technique was employed . Postoperative instructions and a pain question naire were given to each patient to record the severity of their pain at 3 time intervals-3 - 5 hours , 24 hours , and 48 hours after surgery-on a st and ard visual analog scale ( VAS ) . Patients were also asked to record consumption of any self-prescribed analgesics , the type , and dosage . RESULTS At 3 - 5 hours after surgery , regardless of the material used , 90 % of all patients experienced some level of postoperative pain . Twenty-four hours after surgery 82 % of patients experienced pain , as did 72 % after 48 hours . Thirty-seven percent of patients did not take any analgesics at all . In order of popularity , the analgesics taken were ibuprofen , acetaminophen , and acetaminophen plus codeine phosphate . The VAS measurements were reduced over time in both treatment groups ( P < .001 ) . There was no statistically significant difference in the proportion of subjects taking analgesics in each treatment group . Patients who used analgesics showed higher median VAS measurements at all time periods ( P < .05 ) . CONCLUSIONS There was no significant difference in the pain experienced by both treatment groups . The postoperative pain was of a relatively short duration , at its maximum intensity early in the postoperative period but progressively decreased with time . Even if pain relief medication was needed , nonprescription analgesics were adequate and effective OBJECTIVES This prospect i ve r and omized study compared the outcome of retreatment and surgical intervention in root canal treated teeth with nonhealing periradicular pathosis . STUDY DESIGN One such tooth from each of 38 patients was r and omly allotted to retreatment or root-end resection and root-end filling . Treatment outcome after 1 year was evaluated and compared clinical ly and radiographically . RESULTS The success rate for surgery was higher than for conventional retreatment , but the difference was not statistically significant . CONCLUSIONS For management of nonhealing periradicular pathosis associated with root canal treated teeth , surgical intervention should be considered as an alternative to retreatment . In cases with a similar prognosis for both modes of treatment , the choice should be governed by consideration of intrinsic and extrinsic factors INTRODUCTION The purpose of the present study was to evaluate the clinical outcomes of endodontic microsurgery when super ethoxy-benzoic acid ( Super EBA ; Harry J. Bosworth , Skokie , IL ) and mineral trioxide aggregate ( MTA ) were used as root-end filling material s in a prospect i ve r and omized controlled study . METHODS Of the 388 teeth eligible for endodontic microsurgery , 128 teeth were excluded from the study , and 260 teeth were r and omly assigned to either the Super EBA group or the MTA group with OUTPUT: Available evidence does not provide clinicians with reliable guidelines for treating periapical lesions . INPUT: INTRODUCTION Recent meta-analyses of the outcome of apical surgery using modern techniques including microsurgical principles and high-power magnification have yielded higher rates of healing . However , the information is mainly based on 1- to 2-year follow-up data . The present prospect i ve study was design ed to re-examine a large sample of teeth treated with apical surgery after 5 years . METHODS Patients were recalled 5 years after apical surgery , and treated teeth were classified as healed or not healed based on clinical and radiographic examination . ( The latter was performed independently by 3 observers ) . Two different methods of root-end preparation and filling ( primary study parameters ) were to be compared ( mineral trioxide aggregate [ MTA ] vs adhesive resin composite [ COMP ] ) without r and omization . RESULTS A total of 271 patients and teeth from a 1-year follow-up sample of 339 could be re-examined after 5 years ( dropout rate = 20.1 % ) . The overall rate of healed cases was 84.5 % with a significant difference ( P = .0003 ) when comparing MTA ( 92.5 % ) and COMP ( 76.6 % ) . The evaluation of secondary study parameters yielded no significant difference for healing outcome when comparing subcategories ( ie , sex , age , type of tooth treated , post/screw , type of surgery ) . CONCLUSIONS The results from this prospect i ve nonr and omized clinical study with a 5-year follow-up of 271 teeth indicate that MTA exhibited a higher healing rate than COMP in the longitudinal prognosis of root-end sealing OBJECTIVE R and omized clinical prospect i ve study to evaluate the application of MTA and IRM as retro grade sealers in surgical endodontics . STUDY DESIGN One hundred single-rooted teeth were surgically treated . After r and omization , MTA or IRM was used as a retrosealer . Radiographs were taken 1 week , 3 months , and 1 year postoperatively . Assessment was performed by 2 independent assessors 1 year after surgery . Both treatment groups were homogeneous in their composition , and clinical features and radiographic findings were classified according to Rud 's classification . RESULTS Complete healing was observed in 64 % of the MTA-treated teeth vs 50 % of the IRM-treated teeth . Incomplete healing was seen in 28 % ( MTA ) vs 36 % ( IRM ) , and unsatisfactory in 6 % ( MTA ) vs 14 % ( IRM ) . Only 1 failure was seen ( MTA ) . No statistically significant differences were found between the 2 retrofilling material s. CONCLUSION As root-end filling material s in this clinical prospect i ve r and omized design on single rooted teeth , MTA and IRM had the same clinical effectiveness INTRODUCTION This prospect i ve study examined the potential prognostic factors of endodontic microsurgery and compared the predictors of an isolated endodontic lesion with those of both an isolated endodontic lesion and an endodontic-periodontal lesion . METHODS Data were collected from the Microscope Center of the Department of Conservative Dentistry at the Dental College of Yonsei University , Seoul , Korea , between March 2001 and March 2011 . A total number of 584 teeth were included , and all clinical procedures were performed by a single operator ( E.K. ) . The evaluation was performed at least 1 year after surgery . For statistical analysis of the predisposing factors , the chi-square test and logistic regression were performed . RESULTS Of the 584 cases treated , 431 cases came for recall after a period of at least 12 months . Sex ( female ) , tooth position ( anterior ) , arch type ( maxilla ) , and lesion type ( isolated endodontic lesion ) were found to have a positive effect on surgical outcome . With regards to isolated endodontic lesions , the tooth position ( anterior ) , arch type ( maxilla ) , and type of restoration ( single/splinted crown , short bridge , and removable partial denture abutment ) were found to be pure positive predictors . CONCLUSIONS In endodontic microsurgery , it is likely that preoperative factors , particularly the tooth position and arch type , have a greater influence on the healing outcome than intra- and post-operative factors The two objectives of the present study were : to assess the healing after periradicular surgery using the Periotest device , and to compare the recorded Periotest values with the healing category determined after a one-year follow-up using radiographic and clinical criteria . In 43 patients with periradicular surgery , Periotest values could be recorded pre- and postoperatively , as well as after six and twelve months . Cases with a successful healing , as determined at the one-year follow-up , demonstrated a continuous decrease of the Periotest values over time , whereas one-year failures showed increasing Periotest values over the study period . In control teeth , the Periotest values remained unchanged for the whole study period . It appears that the Periotest measurements correlate with the postoperative healing mode following periradicular surgery , and therefore , allow an additional assessment of the healing outcome OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement OUTPUT:

Conclusions : The probability for success for EMS proved to be significantly greater than the probability for success for RES , providing best available evidence on the influence of cavity preparation with ultrasonic tips and /or SuperEBA ( Keystone Industries , Gibbstown , NJ ) , IRM ( Dentsply Sirona , York , PA ) , MTA , or silicate cements as root‐end filling material instead of a shallow cavity preparation and placement of a resin‐based material . HIGHLIGHTSEndodontic microsurgery ( EMS ) with the use of high‐magnification ultrasonic root‐end preparation and root‐end filling with SuperEBA , IRM , MTA , or other calcium silicate cements has a high probability of success . Resin‐based endodontic surgery with the use of high‐magnification preparation of a shallow concave root‐end cavity with bonded resin‐based root‐end filling material performed less favorably than EMS

MS2_dynamic_1_shot73

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Walnuts are rich in polyunsaturated fatty acids and have been shown to improve various cardiometabolic risk factors . We aim ed to investigate the association between walnut intake and incident type 2 diabetes in 2 large cohort studies : the Nurses ’ Health Study ( NHS ) and NHS II . We prospect ively followed 58,063 women aged 52–77 y in NHS ( 1998–2008 ) and 79,893 women aged 35–52 y in NHS II ( 1999–2009 ) without diabetes , cardiovascular disease , or cancer at baseline . Consumption of walnuts and other nuts was assessed every 4 y using vali date d food frequency question naires . Self-reported type 2 diabetes was confirmed by a vali date d supplemental question naire . We documented a total of 5930 incident type 2 diabetes cases during 10 y of follow-up . In the multivariable-adjusted Cox proportional hazards model without body mass index ( BMI ) , walnut consumption was associated with a lower risk of type 2 diabetes , and the HRs ( 95 % CIs ) for participants consuming 1–3 servings/mo ( 1 serving = 28 g ) , 1 serving/wk , and ≥2 servings/wk of walnuts were 0.93 ( 0.88–0.99 ) , 0.81 ( 0.70–0.94 ) , and 0.67 ( 0.54–0.82 ) compared with women who never/rarely consumed walnuts ( P-trend < 0.001 ) . Further adjustment for up date d BMI slightly attenuated the association and the HRs ( 95 % CIs ) were 0.96 ( 0.90–1.02 ) , 0.87 ( 0.75–1.01 ) , and 0.76 ( 0.62–0.94 ) , respectively ( P-trend = 0.002 ) . The consumption of total nuts ( P-trend < 0.001 ) and other tree nuts ( P-trend = 0.03 ) was also inversely associated with risk of type 2 diabetes , and the associations were largely explained by BMI . Our results suggest that higher walnut consumption is associated with a significantly lower risk of type 2 diabetes in women Almonds , together with other nuts , reduce serum cholesterol levels and may reduce the risk of coronary heart disease . There is much current interest in the relation of coronary heart disease to postpr and ial events . We have therefore assessed the effects of varying amounts of almonds on the postpr and ial blood glucose response to a carbohydrate meal . Our aim was to assess the effect of adding almonds to a bread meal . Nine healthy volunteers ( 2 women , 7 men ; mean age , 27.8 years ; mean body mass index , 22.9 kg/m2 ) were r and omly fed with 3 test meals and 2 white bread control meals on separate days . Subjects were fed the meals after a 10- to 12-hour overnight fast . Each meal contained 50 g of available carbohydrate from white bread eaten alone or with 30 , 60 , or 90 g ( approximately 1 , 2 , or 3 oz ) of almonds . Capillary finger-prick blood sample s for glucose analysis were obtained at 0 , 15 , 30 , 45 , 60 , 90 , and 120 minutes . Glycemic responses were assessed by calculating the incremental area under the 2-hour blood glucose curve . The addition of almonds to white bread result ed in a progressive reduction in the glycemic index of the composite meal in a dose-dependent manner for the 30-g ( 105.8 + /- 23.3 ) , 60-g ( 63.0 + /- 9.0 ) , and 90-g ( 45.2 + /- 5.8 ) doses of almonds ( r = -0.524 , n = 36 , P = .001 ) . We conclude that , in addition to lowering serum cholesterol levels , almonds may also reduce the glycemic impact of carbohydrate foods with which they are eaten The etiology of leukemias can not entirely be explained by known risk factors , including ionizing radiation , benzene exposure , and infection with human T cell leukemia virus . A number of studies suggested that diet influences the risk of adult leukemias . However , results have been largely inconsistent . We examined the potential association between dietary factors and risk of leukemias among participants of the European Prospect i ve Investigation into Cancer and Nutrition study . Among the 477,325 participants with mean follow-up of 11.34 yr ( SD = 2.47 ) , 773 leukemias ( 373 and 342 cases of lymphoid and myeloid leukemia , respectively ) were identified . Diet over the previous 12 mo was assessed at baseline using a vali date d country-specific dietary question naire . Cox proportional hazards regression was used to explore the association between dietary factors that have previously been associated with leukemia risk , including red and processed meat , poultry , offal , fish , dairy products , vegetables , fruits , and seeds/nuts , and risk of both lymphoid and myeloid leukemias . No significant associations were observed between dietary measures and total , lymphoid , and myeloid leukemias . Additional subtype analyses showed no dietary association with risk of major subtypes of leukemias . In summary , this study did not support a possible link between selected dietary factors and risk of leukemias OBJECTIVE To test the effects of two Mediterrane OUTPUT: No significant association was found with other cancers or type 2 diabetes . Nut consumption may play a role in reducing cancer risk . INPUT: Walnuts are rich in polyunsaturated fatty acids and have been shown to improve various cardiometabolic risk factors . We aim ed to investigate the association between walnut intake and incident type 2 diabetes in 2 large cohort studies : the Nurses ’ Health Study ( NHS ) and NHS II . We prospect ively followed 58,063 women aged 52–77 y in NHS ( 1998–2008 ) and 79,893 women aged 35–52 y in NHS II ( 1999–2009 ) without diabetes , cardiovascular disease , or cancer at baseline . Consumption of walnuts and other nuts was assessed every 4 y using vali date d food frequency question naires . Self-reported type 2 diabetes was confirmed by a vali date d supplemental question naire . We documented a total of 5930 incident type 2 diabetes cases during 10 y of follow-up . In the multivariable-adjusted Cox proportional hazards model without body mass index ( BMI ) , walnut consumption was associated with a lower risk of type 2 diabetes , and the HRs ( 95 % CIs ) for participants consuming 1–3 servings/mo ( 1 serving = 28 g ) , 1 serving/wk , and ≥2 servings/wk of walnuts were 0.93 ( 0.88–0.99 ) , 0.81 ( 0.70–0.94 ) , and 0.67 ( 0.54–0.82 ) compared with women who never/rarely consumed walnuts ( P-trend < 0.001 ) . Further adjustment for up date d BMI slightly attenuated the association and the HRs ( 95 % CIs ) were 0.96 ( 0.90–1.02 ) , 0.87 ( 0.75–1.01 ) , and 0.76 ( 0.62–0.94 ) , respectively ( P-trend = 0.002 ) . The consumption of total nuts ( P-trend < 0.001 ) and other tree nuts ( P-trend = 0.03 ) was also inversely associated with risk of type 2 diabetes , and the associations were largely explained by BMI . Our results suggest that higher walnut consumption is associated with a significantly lower risk of type 2 diabetes in women BACKGROUND The appropriate dietary intervention for overweight persons with type 2 diabetes mellitus ( DM2 ) is unclear . Trials comparing the effectiveness of diets are frequently limited by short follow-up times and high dropout rates . AIM The effects of a low carbohydrate Mediterranean ( LCM ) , a traditional Mediterranean ( TM ) , and the 2003 American Diabetic Association ( ADA ) diet were compared , on health parameters during a 12-month period . METHODS In this 12-month trial , 259 overweight diabetic patients ( mean age 55 years , mean body mass index 31.4 kg/m(2 ) ) were r and omly assigned to one of the three diets . The primary end-points were reduction of fasting plasma glucose , HbA1c and triglyceride ( TG ) levels . RESULTS 194 patients out of 259 ( 74.9 % ) completed follow-up . After 12 months , the mean weight loss for all patients was 8.3 kg : 7.7 kg for ADA , 7.4 kg for TM and 10.1 kg for LCM diets . The reduction in HbA1c was significantly greater in the LCM diet than in the ADA diet ( -2.0 and -1.6 % , respectively , p < 0.022 ) . HDL cholesterol increased ( 0.1 mmol/l + /- 0.02 ) only on the LCM ( p < 0.002 ) . The reduction in serum TG was greater in the LCM ( -1.3 mmol/l ) and TM ( -1.5 mmol/l ) than in the ADA ( -0.7 mmol/l ) , p = 0.001 . CONCLUSIONS An intensive 12-month dietary intervention in a community-based setting was effective in improving most modifiable cardiovascular risk factors in all the dietary groups . Only the LCM improved HDL levels and was superior to both the ADA and TM in improving glycaemic control Saturated fatty acids ( SFA ) and monounsaturated fatty acids ( MUFA ) show different effects on the development of insulin resistance . In this study , we compared the effect of dietary SFA and MUFA on the insulin signaling pathway in the skeletal muscle of a type 2 diabetic animal model . Twenty-nine-week-old male Otsuka Long-Evans Tokushima fatty ( OLETF ) rats were r and omly divided into three groups and fed one of the following diets for 3 weeks ; a normal chow diet , an SFA ( lard oil ) enriched or a MUFA ( olive oil ) enriched high-fat diet . The vastus lateralis muscle was used for analyses . Insulin tolerance test showed improved insulin sensitivity in rats fed the MUFA diet , as compared to those fed the SFA diet ( p < 0.001 ) . The SFA diet reduced IRS-1 expression and phosphorylated PI3 K levels in skeletal muscle , as compared with a chow diet ( p < 0.001 , respectively ) . On the contrary , muscle IRS-2 expression and phosphorylated ERK1/2 was significantly increased in rats fed the SFA diet ( p < 0.001 , respectively ) . Membrane translocation of glucose transporter type 4 decreased in the skeletal muscle of rats fed the SFA diet , OUTPUT:

No significant treatment effects were observed for fasting insulin and HOMA-IR , however the direction of effect favoured tree nuts . Pooled analyses show that tree nuts improve glycemic control in individuals with type 2 diabetes , supporting their inclusion in a healthy diet .

MS2_dynamic_1_shot74

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objectives —To evaluate the hormonal response to strenuous endurance exercise performed by elite athletes . Methods —Nine professional cyclists ( mean ( SD ) age 28 ( 1 ) years ; mean ( SD ) Vo2max 75.3 ( 2.3 ) ml/kg/min ) who participated in a three week tour race ( Vuelta a España 1999 ) were selected as subjects . Morning urinary levels of 6-sulphatoxymelatonin ( aMT6s ) and morning serum levels of testosterone , follicle stimulating ( FSH ) , luteinising hormone ( LH ) , and cortisol were measured in each subject at t0 ( before the competition ) , t1 ( end of first week ) , t2 ( end of second week ) , and t3 ( end of third week ) . Urine sample s of aMT6s were also evaluated in the evening at t0 , t1 , t2 , and t3 . Results —Mean urinary aMT6s levels had increased significantly ( p<0.01 ) during the day after each stage ( 1091 ( 33 ) v 683 ( 68 ) ng/ml at t1 ; 955 ( 19 ) v 473 ( 53 ) ng/ml at t2 ; 647 ( 61 ) v 337 ( 47 ) ng/ml at t3 ) . Both morning and evening aMT6s levels decreased significantly during the study . A similar pattern was observed for morning serum levels of cortisol and testosterone . Conclusions —The results suggest that the basal activity of the pineal gl and , adrenal gl and s , and testis may be decreased after consecutive days of intense , long term exercise The acute response of free salivary testosterone ( T ) and cortisol ( C ) concentrations to four resistance exercise ( RE ) protocol s in 23 elite men rugby players was investigated . We hypothesized that hormonal responses would differ among individuals after four distinct RE protocol s : four sets of 10 repetitions ( reps ) at 70 % of 1 repetition maximum ( 1RM ) with 2 minutes ' rest between sets ( 4 × 10 - 70 % ) ; three sets of five reps at 85 % 1RM with 3 minutes ' rest ( 3 × 5 - 85 % ) ; five sets of 15 reps at 55 % 1RM with 1 minute 's rest ( 5 × 15 - 55 % ) ; and three sets of five reps at 40 % 1RM with 3 minutes ' rest ( 3 × 5 - 40 % ) . Each athlete completed each of the four RE protocol s in a r and om order on separate days . T and C concentrations were measured before exercise ( PRE ) , immediately after exercise ( POST ) , and 30 minutes post exercise ( 30 POST ) . Each protocol consisted of four exercises : bench press , leg press , seated row , and squats . Pooled T data did not change as a result of RE , whereas C declined significantly . Individual athletes differed in their T response to each of the protocol s , a difference that was masked when examining the pooled group data . When individual data were retrospectively tabulated according to the protocol in which each athlete showed the highest T response , a significant protocol -dependent T increase for all individuals was revealed . Therefore , RE induced significant individual , protocol -dependent hormonal changes lasting up to 30 minutes after exercise . These individual responses may have important ramifications for modulating adaptation to RE and could explain the variability often observed in studies of hormonal response to RE PURPOSE To assess the effects of different modes of morning ( AM ) exercise on afternoon ( PM ) performance and salivary hormone responses in professional rugby union players . METHODS On 4 occasions ( r and omized , crossover design ) , 15 professional rugby players provided AM ( ~8 AM ) and PM ( ~2 PM ) saliva sample s before PM assessment s of countermovement-jump height , reaction time , and repeated-sprint ability . Control ( passive rest ) , weights ( bench press : 5 × 10 repetitions , 75 % 1-repetition maximum , 90-s intraset recovery ) , cycling ( 6 × 6-s maximal sprint cycling , 7.5 % body mass load , 54-s intraset recovery ) , and running ( 6 × 40-m maximal sprints , 20-s intraset recovery ) interventions preceded ( ~5 h ) PM testing . RESULTS PM sprint performance improved ( P < .05 ) after weights ( > 0.15 ± 0.19 s , > 2.04 % ± 2.46 % ) and running ( > 0.15 ± 0.17 s , > 2.12 % ± 2.22 % ) but not cycling ( P > .05 ) . PM jump height increased after cycling ( 0.012 ± 0.009 m , 2.31 % ± 1.76 % , P < .001 ) and running ( 0.020 ± 0.009 m , 3.90 % ± 1.79 % , P < .001 ) but not weights ( P = .936 ) . Reaction time remained unchanged between trials ( P = .379 ) . Relative to control ( 131 ± 21 pg/mL ) , PM testosterone was greater in weights ( 21 ± 23 pg/mL , 17 % ± 18 % , P = .002 ) and running ( 28 ± 26 pg/mL , 22 % ± 20 % , P = .001 ) but not cycling ( P = .072 ) . Salivary cortisol was unaffected by AM exercise ( P = .540 ) . CONCLUSIONS All modes of AM exercise improved at least 1 marker of PM performance , but running appeared the most beneficial to professional rugby union players . A rationale therefore exists for preceding PM competition with AM exercise BACKGROUND AND PUR OUTPUT: This review found that both physical and psychosocial interventions can alter testosterone and cortisol , and physical performance areas important for rugby union are affected by these changes . The limited literature in the field supports the notion that physical interventions of short duration and high intensity , and psychosocial interventions that create a positive environment may elicit a hormonal response that is associated with favorable performance outcomes . Overall , this review identified that when the testosterone responses to an intervention are notably greater than that of cortisol , favorable outcomes are likely . INPUT: The present investigation compared responses in previously identified physiological , biochemical , and psychological markers of overreaching in triathletes . Sixteen experienced male triathletes ( .VO(2max ) [ mean + /- SD ] = 55.7 + /- 4.9 mL . kg ( -1 ) . min ( -1 ) , age = 31.3 + /- 11.7 yr ) were divided into matched groups according to physical and performance characteristics , and were r and omly assigned to either intensified training ( IT ) or normal training ( NT ) groups . Physiological , biochemical , and psychological measures were taken at baseline , following four weeks of overload training and following a two-week taper . The IT group completed 290 % greater physical training load than the NT group during the overload period . The subjects completed a 3-km run time trial ( 3-km RTT ) each week in order to assess the time course of change in endurance performance . 3-km RTT performance was significantly reduced ( 3.7 + /- 7.5 % ; p < 0.05 ) following four weeks of overload training in the IT group confirming a state of overreaching . During the same period , 3-km RTT performance significantly improved in the NT group ( 3.0 + /- 1.1 % ; p < 0.05 ) . Following the two-week taper , 3-km RTT performance significantly improved in the IT group ( 7.0 + /- 5.6 % ; p < 0.05 ) . Hemoglobin concentration significantly decreased and urea increased in both groups during the overload period ( p < 0.05 ) . During the taper hemoglobin normalized with a greater increase in the IT group compared to the NT group ( p < 0.05 ) . A significant increase in free testosterone to cortisol ratio was also observed in the IT group compared to the NT group during the taper ( p < 0.05 ) . No significant changes were observed for any other biochemical variables during the period of investigation . The RESTQ-76 Sport question naire showed an impaired recovery-stress state with increased training load , which improved following the taper in the IT group ( p < 0.05 ) . These present results suggest that none of the physiological and biochemical variables measured in this study were effective for the early identification of overreaching in experienced triathletes . However , the RESTQ-76 Sport question naire may provide a practical tool for recognizing overreaching in its early stages . These findings have implication s for monitoring training status in athletes in a practical training setting The aim of this study was to identify indicators of non-functional overreaching ( NFOR ) in team sport athletes undertaking intensive training loads . Eighteen semi-professional rugby league players were r and omly assigned into two pair matched groups . One group completed 6 weeks of normal training ( NT ) whilst the other group was deliberately overreached through intensified training ( IT ) . Both groups then completed the same 7-day stepwise training load reduction taper . Multistage fitness test ( MSFT ) performance , $ $ \ifmmode\exp and after\dot\else\exp and after\.\fi{V}{\text{O}}_{{2\max } } $ $ , peak aerobic running velocity ( Vmax ) , maximal heart rate , vertical jump , 10-s cycle sprint performance and body mass were measured pre- and post-training period and following the taper . Hormonal , haematological and immunological parameters were also measured pre-training and following weeks 2 , 4 and 6 of training and post-taper . MANOVA for repeated measures with contrast analysis indicated that MSFT performance and $ $ \ifmmode\exp and after\dot\else\exp and after\.\fi{V}{\text{O}}_{{2\max } } $ $ were significantly reduced in the IT group over time and condition , indicating that a state of overreaching was attained . However , the only biochemical measure that was significantly different between the IT and NT group was the glutamine to glutamate ( Gln/Glu ) ratio even though testosterone , testosterone to cortisol ( T/C ) ratio , plasma glutamate , and CK activity were significantly changed after training in both groups . Positive endurance and power performance changes were observed post-taper in the IT group confirming NFOR . These changes were associated with increases in the T/C ratio and the Gln/Glu ratio and decreases in plasma glutamate and CK activity . These results indicate that although there was no single reliable biochemical marker of NFOR in these athletes , the Gln/Glu ratio and MSFT test may be useful measures for monitoring responses to IT in team sport athletes Objective To verify if in male elite junior soccer players a minimum 1-month performance decrease is accompanied by a mood profile and hormone levels typical of non-functional over-reaching ( NFOR ) . Design A prospect i ve case-control study using a monthly performance monitor with a st and ardised field test to detect the performance changes . Players with a performance decrease lasting at least 1 month were compared with control players without a performance decrease on mood scores and pre-exercise and postexercise levels of stress hormones . Setting Sporting field and sports medical laboratory . Participants Ninety-four young elite soccer players were monitored during the 2006–2008 seasons . Twenty-one players were invited to the laboratory , seven of whom showed a significant performance decrease . Main outcome measures Performance change over time , scores on the profile of mood states and premaximal and postmaximal exercise serum levels of adrenocorticotropic hormone ( ACTH ) , growth hormone ( GH ) and cortisol . Results Players with a performance decrease showed psychological and hormonal changes typical of the non-functional state of over-reaching . Scores were higher on depression and anger , whereas the resting GH levels and ACTH levels after maximal exercise were reduced . ACTH and GH were capable of classifying all but one player correctly as either NFOR or control . Conclusions Performance-related criteria in field tests are capable of identifying players with worsened mood and adaptations of the endocrine system that fit the definition of NFOR . Performance , mood and hormone levels may therefore be considered as valid instruments to OUTPUT:

Basal levels of hormones were mostly normal in athletes with OTS/FOR/NFOR compared with healthy athletes . Distinctly , stimulation tests , mainly performed in maximal exercise conditions , showed blunted GH and ACTH responses in OTS/FOR/NFOR athletes , whereas cortisol and plasma catecholamines showed conflicting findings and the other hormones responded normally . Conclusion Basal hormone levels are not good predictor but blunted ACTH and GH responses to stimulation tests may be good predictors of OTS/FOR/NFOR

MS2_dynamic_1_shot75

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Little is known about how the intensity of exercise influences cardiovascular fitness and body composition , especially in obese adolescents . OBJECTIVE Our goal was to determine the effects of physical training intensity on the cardiovascular fitness , percentage of body fat ( % BF ) , and visceral adipose tissue ( VAT ) of obese adolescents . DESIGN Obese 13 - 16-y-olds ( n = 80 ) were assigned to 1 ) biweekly lifestyle education ( LSE ) , 2 ) LSE + moderate-intensity physical training , or 3 ) LSE + high-intensity physical training . The intervention lasted 8 mo . Physical training was offered 5 d/wk , and the target energy expenditure for all subjects in physical training groups was 1047 kJ ( 250 kcal)/session . Cardiovascular fitness was measured with a multistage treadmill test , % BF with dual-energy X-ray absorptiometry , and VAT with magnetic resonance imaging . RESULTS The increase in cardiovascular fitness in the high-intensity physical training group , but not in the moderate-intensity group , was significantly greater than that in the LSE alone group ( P = 0.009 ) ; no other comparisons of the 3 groups were significant . Compared with the LSE alone group , a group composed of subjects in both physical training groups combined who attended training sessions > or=2 d/wk showed favorable changes in cardiovascular fitness ( P < 0.001 ) , % BF ( P = 0.001 ) , and VAT ( P = 0.029 ) . We found no evidence that the high-intensity physical training was more effective than the moderate-intensity physical training in enhancing body composition . CONCLUSIONS The cardiovascular fitness of obese adolescents was significantly improved by physical training , especially high-intensity physical training . The physical training also reduced both visceral and total-body adiposity , but there was no clear effect of the intensity of physical training OBJECTIVE A r and omized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for African-American girls over a 2-year period of intervention . RESEARCH METHODS AND PROCEDURES Fifty-seven overweight ( mean BMI percentile , 98.3 ) African-American girls ( mean age , 13.2 years ) were r and omly assigned to an interactive behavioral internet program or an internet health education program , the control condition . Overweight parents were also participants in the study . Forty adolescent-parent dyads ( 70 % ) completed the 2-year trial . Outcome data including BMI , body weight , body composition , and weight loss behaviors were collected at baseline and at 6-month intervals . A computer server tracked use of the web sites . RESULTS An intention-to-treat statistical approach was used , with the last observation carried forward . In comparison with the control condition , adolescents in the behavioral program lost more mean body fat ( BF ) ( -1.12 + /- 0.47 % vs. 0.43 + /- 0.47 % BF , p < 0.05 ) , and parents in the behavioral program lost significantly more mean body weight ( -2.43 + /- 0.66 vs. -0.35 + /- 0.64 kg , p < 0.05 ) during the first 6 months . This weight loss was regained over the next 18 months . After 2 years , differences in fat for adolescents ( -0.08 + /- 0.71 % vs. 0.84 + /- 0.72 % BF ) and weight for parents ( -1.1 + /- 0.91 vs. -0.60 + /- 0.89 kg ) did not differ between the behavioral and control programs . DISCUSSION An internet-based weight management program for African-American adolescent girls and their parents result ed in weight loss during the first 6 months but did not yield long-term loss due to reduced use of the web site over time Objective : Since peers have such an important influence on adolescents , we evaluated the efficacy of adding peer-based ‘ adventure therapy ’ to a st and ard cognitive-behavioral weight control program for overweight adolescents . Methods : Adolescents ( N=76 ) aged 13–16 years and 20 to 80 % overweight ( M=60.56 % , s.d.=15.17 % ) , were r and omly assigned to one of two treatment conditions : cognitive-behavioral group treatment with ‘ adventure therapy ’ similar to Outward Bound ® ( cognitive-behavioral treatment with peer-enhanced adventure therapy ( CBT+PEAT ) ) or cognitive-behavioral group treatment with aerobic exercise ( CBT+EXER ) . Anthropometric and psychosocial measures were obtained at baseline , at the end of the 16-week intervention , and at 10 months following r and omization . Results : Adolescents assigned to both treatment conditions demonstrated significant weight loss over time , F=29.06 , df=2 , 53 , P<0.01 . Average weight loss did not differ significantly between groups ( −5.31 kg for CBT+PEAT and −3.20 kg for CBT+EXER ) at the end of treatment . There was a significant difference in the percentage of participants maintaining a minimum 4.5 kg ( 10 pounds ) weight loss ( 35 % in the CBT+PEAT condition vs 12 % in the CBT+EXER condition , P=0.042 ) 10 months from r and omization . We also observed a significant age by treatment group interaction , such that older adolescents r and omized to CBT+PEAT demonstrated more than four times the weight loss of older adolescents assigned to CBT+EXER ( M=−7.86 kg vs M=−1.72 kg ) at the end of treatment . Conclusions : Peer-based ‘ OUTPUT: RESULTS Due to a lack of consistency among the studies regarding methods and rigor of the studies , the evidence is not entirely clear on the best multicomponent program for addressing overweight in middle adolescents . The success of an intervention was associated with the dose of the intervention received by the adolescent and parent . A structured program addressing nutrition , physical activity , and behavioral skills appears to be efficacious in reducing weight and cardiovascular risk factors . INPUT: INTRODUCTION The purpose of this study was to test the hypothesis that physical training ( PT ) , especially high-intensity PT , would have a favorable effect on components of the insulin resistance syndrome ( IRS ) in obese adolescents . METHODS Obese 13- to 16-yr-olds ( N = 80 ) were r and omly assigned to one of the following 8-month interventions ; 1 ) lifestyle education (LSE)-alone every 2 wk , 2 ) LSE+moderate-intensity PT , and 3 ) LSE+high-intensity PT . PT was offered 5 d x wk(-1 ) . Plasma triacylglycerol ( TAG ) , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDLC ) , very low-density lipoprotein cholesterol ( VLDLC ) , low-density lipoprotein cholesterol ( LDLC ) , low-density lipoprotein ( low density lipoprotein ( LDL ) ) particle size , apolipoproteins AI and B , glucose , insulin , and blood pressure were measured with st and ardized methods . RESULTS The intent-to-treat analyses for all subjects who completed pre- and post-tests regardless of their adherence to the interventions showed that the LSE+high-intensity PT group had more favorable changes than the LSE-alone group in TAG level ( P = 0.012 ) , TC/HDLC ( P = 0.013 ) , and diastolic blood pressure ( P = 0.031 ) . For efficacy analyses , all PT subjects who attended at least 2 d x wk(-1 ) ( 40 % ) were combined into one group ( LSE+PT ) and compared with the LSE-alone group . These two-group analyses showed significant interactions ( P < 0.001 ) between baseline values and group membership for deltaTAG , deltaVLDLC , and deltaTC/HDLC , such that subjects who had the least favorable baseline values showed the most beneficial impact of the PT . Of particular interest was a favorable effect of the PT on LDL particle size . CONCLUSION PT , especially high-intensity PT , had a favorable effect on several IRS markers in obese adolescents OBJECTIVES The aim of this study was to determine the effects of physical activity on systemic blood pressure ( BP ) and early markers of atherosclerosis in pre-pubertal obese children . BACKGROUND Hypertension and endothelial dysfunction are premature complications of obesity . METHODS We performed a 3-month r and omized controlled trial with a modified crossover design : 44 pre-pubertal obese children ( age 8.9 + or - 1.5 years ) were r and omly assigned ( 1:1 ) to an exercise ( n = 22 ) or a control group ( n = 22 ) . We recruited 22 lean children ( age 8.5 + or - 1.5 years ) for baseline comparison . The exercise group trained 60 min 3 times/week during 3 months , whereas control subjects remained relatively inactive . Then , both groups trained twice/week during 3 months . We assessed changes at 3 and 6 months in office and 24-h BP , arterial intima-media thickness ( IMT ) and stiffness , endothelial function ( flow-mediated dilation ) , body mass index ( BMI ) , body fat , cardiorespiratory fitness ( maximal oxygen consumption [ VO(2)max ] ) , physical activity , and biological markers . RESULTS Obese children had higher BP , arterial stiffness , body weight , BMI , abdominal fat , insulin resistance indexes , and C-reactive protein levels , and lower flow-mediated dilation , VO(2)max , physical activity , and high-density lipoprotein cholesterol levels than lean subjects . At 3 months , we observed significant changes in 24-h systolic BP ( exercise -6.9 + or - 13.5 mm Hg vs. control 3.8 + or - 7.9 mm Hg , -0.8 + or - 1.5 st and ard deviation score [ SDS ] vs. 0.4 + or - 0.8 SDS ) , diastolic BP ( -0.5 + or - 1.0 SDS vs. 0 + or - 1.4 SDS ) , hypertension rate ( -12 % vs. -1 % ) , office BP , BMI z-score , abdominal fat , and VO(2)max . At 6 months , change differences in arterial stiffness and IMT were significant . CONCLUSIONS A regular physical activity program reduces BP , arterial stiffness , and abdominal fat ; increases cardiorespiratory fitness ; and delays arterial wall remodeling in pre-pubertal obese children . ( Effects of Aerobic Exercise Training on Arterial Function and Insulin Resistance Syndrome in Obese Children : A R and omized Controlled Trial ; NCT00801645 ) Aims : To evaluate effects of a low energy diet , with or without strength training , on blood lipid profile in obese children . Methods : Eighty two obese children were enrolled into a six week dietary programme , and were r and omly allocated to a training group or a non-training group . The training group underwent regular exercise sessions with emphasis on strength training . Results : Height increased significantly , with a non-significant reduction in body mass index . Fat free mass increased significantly in the training group . Serum total cholesterol was significantly reduced in both groups . The LDL : HDL ratio significantly decreased in the training group . Conclusion : Results support the potentially beneficial effects of both diet and physical training . Further and longer term evaluation of such programmes is required INTRODUCTION Developing effective exercise programmes for the paediatric population is a strategy for decreasing obesity and is expected to help in eventually limiting obesity-associated long OUTPUT:

The programs based on aerobic exercise ( 60 min , 3 times/week , ≤75 % maximum heart rate ) improve the LDL-C and TG concentrations . Moreover , the programs based on combined exercise ( ≥60 min , > 75 % maximum heart rate ) also improve the HDL-C concentration

MS2_dynamic_1_shot76

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE : To estimate the possibility of long-term effects of sub clinical thyroid dysfunction on hypertension and other cardiovascular-related conditions during pregnancy . METHODS : This is a secondary analysis of a prospect i ve prenatal population -based study in which serum thyroid-function analytes were measured from November 2000 through April 2003 . Women with evidence of overt thyroid disease were excluded . The remaining women were classified as being euthyroid , having sub clinical hyperthyroid , or having sub clinical hypothyroid , and the frequency of pregnancy-associated hypertensive disorders was compared between these groups . RESULTS : Pregnancy outcomes in 24,883 women were analyzed for pregnancy hypertension , classified as gestational hypertension , mild preeclampsia , or severe preeclampsia . The incidence of hypertensive disorders were compared between the three cohorts . The overall incidences of hypertension in pregnancy were 6.2 % , 8.5 % , and 10.9 % in the sub clinical hyperthyroid , euthyroid , and sub clinical hypothyroid groups , respectively , and were found to be significant when unadjusted ( P=.016 ) . After adjusting for confounding factors , there was a significant association between sub clinical hypothyroidism and severe preeclampsia ( adjusted odds ratio 1.6 , 95 % confidence interval 1.1–2.4 ; P=.03 ) . CONCLUSION : Women with sub clinical hypothyroidism identified during pregnancy have an increased risk for severe preeclampsia when compared with euthyroid women . LEVEL OF EVIDENCE : New Zeal and has one of the highest incidence rates of Crohn ’s Disease ( CD ) , whilst the serum selenium status of New Zeal and ers is amongst the lowest in the world . A prospect i ve case-control study in Auckl and , New Zeal and considered serum selenium as a potential CD risk factor . Serum selenium levels were significantly lower in CD patients compared to controls ( 101.8 ± 1.02 vs. 111.1 ± 1.01 ng/mL ) ( p = 5.91 × 10−8 ) . Recent detailed studies in the United Kingdom have suggested an optimal serum level around 122 ng/mL , making the average CD patient in New Zeal and selenium deficient . Of the 29 single nucleotide polymorphisms ( SNPs ) tested , 13 were found to significantly interact with serum selenium on CD . After adjustment for multiple testing , a significant interaction with serum selenium on CD was found for three SNPs , namely rs17529609 and rs7901303 in the gene SEPHS1 , and rs1553153 in the gene SEPSECS . These three SNPs have not been reported elsewhere as being significantly associated with selenium or CD . It is unclear as to whether lower selenium levels are a cause or an effect of the disease Type II deiodinase ( D2 ) is important in the regulation of local thyroid hormone bioactivity in certain tissues . D2 in skeletal muscle may also play a role in serum triiodothyronine ( T(3 ) ) production . In this study , we identified a polymorphism in the 5'-UTR of the D2 gene ( D2-ORFa-Gly3Asp ) . We investigated the association of D2-ORFa-Gly3Asp , and of the previously identified D2-Thr92Ala polymorphism , with serum iodothyronine levels . D2-ORFa-Gly3Asp was identified by sequencing the 5'-UTR of 15 r and omly selected individuals . Genotypes for D2-ORFa-Gly3Asp were determined in 156 healthy blood donors ( age 46.3 + /- 12.2 yr ) and 349 ambulant elderly men ( age 77.7 + /- 3.5 yr ) and related to serum iodothyronine and TSH levels . D2-ORFa-Asp(3 ) had an allele frequency of 33.9 % in blood bank donors and was associated with serum thyroxine ( T(4 ) ; Gly/Gly vs. Gly/Asp vs. Asp/Asp = 7.06 + /- 0.14 vs. 6.74 + /- 0.15 vs. 6.29 + /- 0.27 microg/dl , P = 0.01 ) , free T(4 ) ( 1.22 + /- 0.02 vs. 1.16 + /- 0.02 vs. 1.06 + /- 0.04 ng/dl , P = 0.001 ) , reverse T(3 ) ( P = 0.01 ) , and T(3)/T(4 ) ratio ( P = 0.002 ) in a dose-dependent manner , but not with serum T(3 ) ( P = 0.59 ) . In elderly men , D2-ORFa-Asp(3 ) had a similar frequency but was not associated with serum iodothyronine levels . This new polymorphism in the 5'-UTR of D2 is associated with iodothyronine levels in blood donors but not in elderly men . We hypothesize that this might be explained by the decline in skeletal muscle size during aging , result ing in a relative decrease in the contribution of D2 to serum T(3 ) production Single nucleotide polymorphisms ( SNPs ) in genes involved in thyroid hormone metabolism may affect thyroid hormone bioactivity . We investigated the occurrence and possible effects of SNPs in the deiodinases ( D1-D3 ) , the TSH receptor ( TSHR ) , and the T(3 ) receptor beta ( TR beta ) genes . SNPs were identified in public data bases or by sequencing of genomic DNA from 15 r and omly selected subjects ( 30 alleles ) . Genotypes for the identified SNPs were determined OUTPUT: Deiodinase type 1 ( D1 ) polymorphisms particularly show moderate-to-strong relationships with thyroid hormone parameters , IGF1 production , and risk for depression . D2 variants correlate with thyroid hormone levels , insulin resistance , bipolar mood disorder , psychological well-being , mental retardation , hypertension , and risk for osteoarthritis . D3 polymorphisms showed no relationship with inter-individual variation in serum thyroid hormone parameters . One D3 polymorphism was associated with risk for osteoarthritis . Genetic deiodinase profiles only explain a small proportion of inter-individual variations in serum thyroid hormone levels . Evidence suggests a role of genetic deiodinase variants in certain pathophysiological conditions . INPUT: Reduced maternal thyroid hormone concentrations during pregnancy can adversely affect fetal neurological development . In the context of national iodine supplementation programmes , concern has been expressed over the theoretical possibility that iodine supplementation during pregnancy might adversely affect fetal development as a result of maternal thyroid inhibition from the Wolff-Chaikoff effect . In a double blind controlled trial in five villages in Papua New Guinea , several measures of motor and cognitive function showed no significant differences at either age 11 or 15 years between those children whose mothers had received supplementary iodine during pregnancy and the control children whose mothers had received the placebo Abstract Endemic cretinism is characterised by multiple neurological defects including deaf-mutism , diplegia , squint , and mental deficiency . The condition is widely prevalent in the Highl and s of New Guinea in association with severe iodine deficiency . Previous studies have shown that iodised oil provides a very satisfactory correction of severe iodine deficiency in New Guinea . A controlled trial on the use of intramuscular iodised oil in the prevention of endemic cretinism was carried out in the Western Highl and s of New Guinea and involved a population of approximately 8000 . Subsequent follow-up over four years revealed 26 endemic cretins out of a total of 534 children born to mothers who had not received iodised oil ; the mothers of 5 of these cretins were pregnant at the start of the trial . In comparison , 7 cases of endemic cretinism occurred among 498 children born to mothers who had been treated with iodised oil ; in 6 of these 7 cases , the mother was pregnant when the trial commenced . It is concluded that intramuscular iodised oil is effective in the prevention of endemic cretinism and that , for it to be effective , it should be given prior to conception . This suggests that severe iodine deficiency in the mother produces neurological damage during fetal development One hundred and eighty euthyroid pregnant women were selected at the end of the first trimester of gestation on the basis of biochemical criteria of excessive thyroid stimulation , defined as supranormal serum thyroglobulin ( TG > 20 micrograms/L ) associated with a low normal free T4 index ( < 1.23 ) and /or an increased T3/T4 ratio ( > 25 x 10(-3 ) ) . Women were r and omized in a double blind protocol into three groups and treated until term with a placebo , 100 micrograms potassium iodide (KI)/day , or 100 micrograms iodide plus 100 micrograms L-T4/day . Parameters of thyroid function , urinary iodine excretion , and thyroid volume were monitored sequentially . Neonatal thyroid parameters , including thyroid volume by echography , were also assessed in the newborns from mothers of the three groups . In women receiving a placebo , the indices of excessive thyroid stimulation worsened as gestation progressed , with low free T4 levels , markedly increased serum TG and T3/T4 ratio . Serum TSH doubled , on the average , and was supranormal in 20 % of the cases at term . Urinary iodine excretion levels were low , around 30 micrograms/L at term . The thyroid volume increased , on the average , by 30 % , and 16 % of the women developed a goiter , confirming the goitrogenic stimulus associated with pregnancy . Moreover , the newborns of these mothers had significantly larger thyroid volumes at birth as well as elevated serum TG levels . In both groups of women receiving an active treatment , the alterations in thyroid function associated with pregnancy were markedly improved . The increase in serum TSH was almost suppressed , serum TG decreased significantly , and changes in thyroid volume were minimized ( group receiving KI ) or almost suppressed ( group receiving KI combined with L-T4 ) . Moreover , in the newborns of the mothers in the two groups receiving an active treatment , serum TG was significantly lower , and thyroid volume at birth was normal . The effects of therapy were clearly more rapid and more marked in the group receiving a combination of T4 and KI than in the women receiving KI alone . The differences could be partly attributed to the slightly higher amount of iodine received by women in the combined treatment . However , the main benefits of the combined treatment were almost certainly attributable to the hormonal effects of the addition of L-T4 . Furthermore , the study demonstrated that the administration of T4 did not hamper the beneficial effect of iodine supplementation . In conclusion , the present work emphasizes the potential risk of goitrogenic stimulation in both mother and newborn in the presence of mild iodine deficiency . ( ABSTRACT TRUNCATED AT 400 WORDS The prevalence of iodine deficiency disorders and the thyroid status of the population were studied in an endemic goitre area in Algeria . After oral administration of lipiodol ( 0.5 ml ) , three treated groups of mother-newborn couples were compared to an untreated group : group A , mothers treated 1 - 3 months before conception ; group B , mothers treated during the first month of pregnancy ; group C , mothers treated during the third month of pregnancy . Untreated mothers were used as a control ( group D ) . After lipiodol treatment , all newborn babies and mothers were clinical ly euthyroid . All tested newborn babies were full term and no goitre was observed in the four groups . In the mothers , goitre prevalence and thyrotrophin levels decreased significantly , whereas maternal milk and urinary iodine and serum-free thyroxine levels were significantly higher after treatment . The rate of prematurity , stillbirths and abortions in the treated groups was reduced when compared to the untreated group , whereas placental and birth weights were significantly higher . In group D two cases of neonatal hypothyroidism were detected . Their re-evaluation confirmed that hypothyroidism was transient . Groups A , B and C OUTPUT:

REVIEW ER 'S CONCLUSIONS Iodine supplementation in a population with high levels of endemic cretinism results in an important reduction in the incidence of the condition with no apparent adverse effects

MS2_dynamic_1_shot77

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Epidemiological studies have shown television watching to be a risk factor for the development of obesity in children . The effect of reducing television watching and other sedentary behaviors as a component of a comprehensive obesity treatment program has not been thoroughly tested . OBJECTIVE To compare the influence of targeting decreases in sedentary behavior vs. increases in physical activity in the comprehensive treatment of obesity in 8- to 12-year-old children . DESIGN R and omized , controlled outcome study . SETTING Childhood obesity research clinic . DESIGN Ninety families with obese 8- to 12-year-old children were r and omly assigned to groups that were provided a comprehensive family-based behavioral weight control program that included dietary , and behavior change information but differed in whether sedentary or physically active behaviors were targeted and the degree of behavior change required . RESULTS Results during 2 years showed that targeting either decreased sedentary behaviors or increased physical activity was associated with significant decreases in percent overweight and body fat and improved aerobic fitness . Self-reported activity minutes increased and targeted sedentary time decreased during treatment . Children substituted nontargeted sedentary behaviors for some of their targeted sedentary behaviors . CONCLUSION These results support reducing sedentary behaviors as an adjunct in the treatment of pediatric obesity BACKGROUND Little is known about how the intensity of exercise influences cardiovascular fitness and body composition , especially in obese adolescents . OBJECTIVE Our goal was to determine the effects of physical training intensity on the cardiovascular fitness , percentage of body fat ( % BF ) , and visceral adipose tissue ( VAT ) of obese adolescents . DESIGN Obese 13 - 16-y-olds ( n = 80 ) were assigned to 1 ) biweekly lifestyle education ( LSE ) , 2 ) LSE + moderate-intensity physical training , or 3 ) LSE + high-intensity physical training . The intervention lasted 8 mo . Physical training was offered 5 d/wk , and the target energy expenditure for all subjects in physical training groups was 1047 kJ ( 250 kcal)/session . Cardiovascular fitness was measured with a multistage treadmill test , % BF with dual-energy X-ray absorptiometry , and VAT with magnetic resonance imaging . RESULTS The increase in cardiovascular fitness in the high-intensity physical training group , but not in the moderate-intensity group , was significantly greater than that in the LSE alone group ( P = 0.009 ) ; no other comparisons of the 3 groups were significant . Compared with the LSE alone group , a group composed of subjects in both physical training groups combined who attended training sessions > or=2 d/wk showed favorable changes in cardiovascular fitness ( P < 0.001 ) , % BF ( P = 0.001 ) , and VAT ( P = 0.029 ) . We found no evidence that the high-intensity physical training was more effective than the moderate-intensity physical training in enhancing body composition . CONCLUSIONS The cardiovascular fitness of obese adolescents was significantly improved by physical training , especially high-intensity physical training . The physical training also reduced both visceral and total-body adiposity , but there was no clear effect of the intensity of physical training BACKGROUND Excessive weight in childhood is a serious public health concern because of its costly health consequences and its increasing prevalence . OBJECTIVE Our objective was to compare the efficacy of a family-based approach for the treatment of childhood obesity , in which the parents served as the exclusive agents of change , with that of the conventional approach , in which the children served as the agents of change . DESIGN This study had a r and omized , longitudinal prospect i ve design and lasted 1 y. Sixty obese children aged 6 - 11 y were r and omly allocated to the experimental ( parents as agents of change ) or control ( children as agents of change ) group . Anthropometric and biochemical measurements were determined at the start and end of the study . A sociodemographic question naire and a family eating and activity habits question naire were completed by both parents . Hour-long support and educational sessions were conducted by a clinical dietitian : 14 sessions for the parents in the experimental group and 30 sessions for the children in the control group . RESULTS The dropout rate was nine times greater in the control group ( n = 9 ) than in the experimental group ( n = 1 ) . Mean percentile weight reduction was significantly ( P < 0.03 ) higher in children in the experimental group ( 14.6 % ) than in the control group ( 8.1 % ) . CONCLUSIONS Treatment of childhood obesity with parents as the exclusive agents of change was superior to the conventional approach , as indicated by the dropout rate and the percentage weight loss of the children during the 1-y intervention We report 10-year treatment outcomes for obese children in 4 r and omized treatment studies . At 10 years , 34 % decreased percentage overweight by 20 % or more , and 30 % were not obese . Significant effects were observed when parents and children were targeted and reinforced for weight loss in comparison with nontargeted controls and for children given lifestyle or aerobic exercise in comparison with a calisthenics control . Thirty-four percent of the variance in change in percentage overweight was predicted from sex , baseline percentage overweight , self-monitoring weight , meals eaten at home , and family and friends ' support for eating and exercise . Results show long-term changes in children depend on the treatment , and evidence converges on the importance of the family and other sources of support for eating and activity change OBJECTIVE The goal of this study was to evaluate the effect of a parent-focused behavioral intervention on parent and child eating changes and on percentage of overweight changes in families that contain at least one obese parent and a non-obese child . RESEARCH METHODS AND PROCEDURES Families with obese parents and non-obese children were r and omized OUTPUT: DATA SYNTHESIS The 2 strongly qualified meta-analyses suggest that interventions that include a dietary treatment do achieve relative weight loss . It is not possible to evaluate the effectiveness of dietary treatment for childhood obesity because of the lack of high- quality studies and the heterogeneity of design s , treatment combinations , outcome measures , and follow-up . INPUT: BACKGROUND Epidemiological studies have shown television watching to be a risk factor for the development of obesity in children . The effect of reducing television watching and other sedentary behaviors as a component of a comprehensive obesity treatment program has not been thoroughly tested . OBJECTIVE To compare the influence of targeting decreases in sedentary behavior vs. increases in physical activity in the comprehensive treatment of obesity in 8- to 12-year-old children . DESIGN R and omized , controlled outcome study . SETTING Childhood obesity research clinic . DESIGN Ninety families with obese 8- to 12-year-old children were r and omly assigned to groups that were provided a comprehensive family-based behavioral weight control program that included dietary , and behavior change information but differed in whether sedentary or physically active behaviors were targeted and the degree of behavior change required . RESULTS Results during 2 years showed that targeting either decreased sedentary behaviors or increased physical activity was associated with significant decreases in percent overweight and body fat and improved aerobic fitness . Self-reported activity minutes increased and targeted sedentary time decreased during treatment . Children substituted nontargeted sedentary behaviors for some of their targeted sedentary behaviors . CONCLUSION These results support reducing sedentary behaviors as an adjunct in the treatment of pediatric obesity Background Schools are the most frequent target for intervention programs aim ed at preventing child obesity ; however , the overall effectiveness of these programs has been limited . It has therefore been recommended that interventions target multiple ecological levels ( community , family , school and individual ) to have greater success in changing risk behaviors for obesity . This study examined the immediate and short-term , sustained effects of the Switch program , which targeted three behaviors ( decreasing children 's screen time , increasing fruit and vegetable consumption , and increasing physical activity ) at three ecological levels ( the family , school , and community ) . Methods Participants were 1,323 children and their parents from 10 schools in two states . Schools were matched and r and omly assigned to treatment and control . Measures of the key behaviors and body mass index were collected at baseline , immediately post-intervention , and 6 months post-intervention . Results The effect sizes of the differences between treatment and control groups ranged between small ( Cohen 's d = 0.15 for body mass index at 6 months post-intervention ) to large ( 1.38 ; parent report of screen time at 6 months post-intervention ) , controlling for baseline levels . There was a significant difference in parent-reported screen time at post-intervention in the experimental group , and this effect was maintained at 6 months post-intervention ( a difference of about 2 hours/week ) . The experimental group also showed a significant increase in parent-reported fruit and vegetable consumption while child-reported fruit and vegetable consumption was marginally significant . At the 6-month follow-up , parent-reported screen time was significantly lower , and parent and child-reported fruit and vegetable consumption was significantly increased . There were no significant effects on pedometer measures of physical activity or body mass index in the experimental group . The intervention effects were moderated by child sex ( for fruit and vegetable consumption , physical activity , and weight status ) , family involvement ( for fruit and vegetable consumption ) , and child body mass index ( for screen time ) . The perception of change among the experimental group was generally positive with 23 % to 62 % indicating positive changes in behaviors . Conclusion The results indicate that the Switch program yielded small-to-modest treatment effects for promoting children 's fruit and vegetable consumption and minimizing screen time . The Switch program offers promise for use in youth obesity prevention OBJECTIVE To evaluate the impact of a school-based health behavior intervention known as Planet Health on obesity among boys and girls in grade s 6 to 8 . DESIGN R and omized , controlled field trial with 5 intervention and 5 control schools . Outcomes were assessed using preintervention ( fall 1995 ) and follow-up measures ( spring 1997 ) , including prevalence , incidence , and remission of obesity . PARTICIPANTS A group of 1295 ethnically diverse grade 6 and 7 students from public schools in 4 Massachusetts communities . INTERVENTION Students participated in a school-based interdisciplinary intervention over 2 school years . Planet Health sessions were included within existing curricula using classroom teachers in 4 major subjects and physical education . Sessions focused on decreasing television viewing , decreasing consumption of high-fat foods , increasing fruit and vegetable intake , and increasing moderate and vigorous physical activity . MAIN OUTCOME MEASURES Obesity was defined as a composite indicator based on both a body mass index and a triceps skinfold value greater than or equal to age- and sex-specific 85th percentiles . Because schools were r and omized , rather than students , the generalized estimating equation method was used to adjust for individual-level covariates under cluster r and omization . RESULTS The prevalence of obesity among girls in intervention schools was reduced compared with controls , controlling for baseline obesity ( odds ratio , 0.47 ; 95 % confidence interval , 0.24 - 0.93 ; P = .03 ) , with no differences found among boys . There was greater remission of obesity among intervention girls vs. control girls ( odds ratio , 2.16 ; 95 % confidence interval , 1.07 - 4.35 ; P = .04 ) . The intervention reduced television hours among both girls and boys , and increased fruit and vegetable consumption and result ed in a smaller increment in total energy intake among girls . Reductions in television viewing predicted obesity change and mediated the intervention effect . Among girls , each hour of reduction in television viewing predicted reduced obesity prevalence ( odds ratio , 0.85 ; 95 % confidence interval , 0.75 - 0.97 ; P = .02 ) . CONCLUSION Planet Health decreased obesity among female students , indicating a promising school-based approach to reducing obesity among youth OBJECTIVE To test a 2-year community- and family-based obesity prevention program for low-income African American girls : Stanford G OUTPUT:

Among children , these interventions demonstrated reduced screen time , increased physical activity , and improved diet- and weight-related outcomes .

MS2_dynamic_1_shot78

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Eighty-seven morbidly obese patients were prospect ively r and omized to two operations : gastric bypass was performed on 42 and gastric partition on 45 . Gastric bypass proved to be more effective ; gastric bypass patients lost 15 % more of their original weight at 12 months and 21 % more at 18 months . There were no failures in the gastric bypass group ; 28 of the 45 operations failed in the gastric partition group . An additional 60 patients underwent gastric bypass since the completion of the study . In the total series of 147 patients who underwent gastric bypass or gastric partition , there was no mortality , and the surgical complication rate was 12 % . Because the gastric pouches and the anastomoses were similar in the two operations , the superiority of the gastric bypass may well be due to a heretofore unexplained effect of distal gastric and duodenal exclusion The present status of 38 patients comprising a clinical trial of jejunoileal and gastric bypass for the treatment of morbid obesity , begun four years ago at North Carolina Memorial Hospital , is reported . Weight loss was greater in patients treated by jejunoileal bypass than those treated by gastric bypass . The poorer weight loss noted in the gastric bypass patients is associated with an excessively large proximal gastric pouch , which had characterized the 19 gastric bypass operations done prior to May 1977 . The weight loss achieved with the current version of the gastric bypass , a smaller proximal gastric pouch , is comparable to that achieved with jejunoileal bypass . The objective and subjective sequelae and complications of jejunoileal bypass are more common and more serious than those of gastric bypass . Gastric bypass is the better operation for the treatment of morbid obesity For 2 years , 12 Danish hospitals have conducted a r and omized clinical trial to evaluate the hazards and benefits of jejunoileal bypass operations for severe obesity . At present ( January , 1976 ) , there are 92 operated and 46 unoperated patients . There has been no mortality in the operated group . One control patient has died . Weight loss is significantly better in the operated group , but not always satisfactory . The well-known postoperative complications have not been deterring in frequency or seriousness . On the whole , but not invariably , the operation has been followed by an improvement in psychosocial status Background : The feasibility of laparoscopic Roux-en-Y gastric bypass ( Lap-RYGBP ) for morbid obesity is well documented . In a prospect i ve r and omized trial , we compared laparoscopic and open surgery . Methods : 51 patients ( 48 females , mean ( ± SD ) age 36 ± 9 years and BMI 42 ± 4 kg/m2 ) were r and omly allocated to either laparoscopy ( n=30 ) or open surgery ( n=21 ) . All patients were followed for a minimum of 1 year . Results : In the laparoscopy group , 7 patients ( 23 % ) were converted to open surgery due to various procedural difficulties . In an analysis , with the converted patients excluded , the morphine doses used postoperatively were significantly ( p < 0.005 ) lower in the laparoscopic group compared to the open group . Likewise , postoperative hospital stay was shorter ( 4 vs 6 days , p<0.025 ) . Six patients in the laparoscopy group had to be re-operated due to Roux-limb obstruction in the mesocolic tunnel within 5 weeks . The weight loss expressed in decrease in mean BMI units after year was 14 and 13 after 1 ± 3 ± 3 laparoscopy and open surgery , respectively ( not significant ) . Conclusions : Both laparoscopic and open RYGBP are effective and well received surgical procedures in morbid obesity . Reduced postoperative pain , shorter hospital stay and shorter sick-leave are obvious benefits of laparoscopy but conversions and /or reoperations in 1/4 of the patients indicate that Lap-RYGBP at present must be considered an investigational procedure OBJECTIVE To examine the effect of a large , long st and ing and intentional weight reduction on the incidence of diabetes , hypertension and lipid disturbances in severely obese individuals as compared to weight-stable obese controls . RESEARCH METHODS AND PROCEDURES The ongoing prospect i ve SOS ( Swedish Obese Subjects ) intervention consists of a surgically treated group and a matched control group obtaining conventional obesity treatment . This report is based on 845 surgically treated patients and 845 controls ( BMI 41.0+/-4.6 kg/m2 ( mean+/-st and ard deviation [ S ] ) ) followed for 2 years . RESULTS Surgically treated patients lost 28+/-15 kg and controls 0.5+/-8.9 kg ( p<0.0001 ) . Two-year incidence of hypertension , diabetes , hyperinsulinemia , and lipid disturbances was compared in the two treatment groups . Adjusted odds ratios ( 95 % CI ) for the surgically treated group versus controls were 0.38 ( 0.22 , 0.65 ) for hypertension , 0.02 ( 0.00 , 0.16 ) for diabetes , 0.10 ( 0.03 , 0.28 ) for hyperinsulinemia , 0 . 10 ( 0.04 , 0.25 ) for hypertriglyceridemia , 0.28 ( 0.16 , 0.49 ) for low HDL-cholesterol and 1.24 ( 0.84 , 1.8 ) for hypercholesterolemia . Compared to controls , the 2-year recovery rates from hypertension , diabetes , hypo-HDL , and hypertrig OUTPUT: Surgery result ed in a significantly greater loss of weight ( 23–37 kg more weight ) than nonsurgical treatment , which was maintained to 8 years and led to improvements in quality of life and comorbidities . : Surgery for morbid obesity appears to be clinical ly and cost effective . Because of the nature of the evidence , particularly the uncertainty in the clinical and economic evaluations , it is difficult to distinguish between the different surgical procedures INPUT: Eighty-seven morbidly obese patients were prospect ively r and omized to two operations : gastric bypass was performed on 42 and gastric partition on 45 . Gastric bypass proved to be more effective ; gastric bypass patients lost 15 % more of their original weight at 12 months and 21 % more at 18 months . There were no failures in the gastric bypass group ; 28 of the 45 operations failed in the gastric partition group . An additional 60 patients underwent gastric bypass since the completion of the study . In the total series of 147 patients who underwent gastric bypass or gastric partition , there was no mortality , and the surgical complication rate was 12 % . Because the gastric pouches and the anastomoses were similar in the two operations , the superiority of the gastric bypass may well be due to a heretofore unexplained effect of distal gastric and duodenal exclusion The present status of 38 patients comprising a clinical trial of jejunoileal and gastric bypass for the treatment of morbid obesity , begun four years ago at North Carolina Memorial Hospital , is reported . Weight loss was greater in patients treated by jejunoileal bypass than those treated by gastric bypass . The poorer weight loss noted in the gastric bypass patients is associated with an excessively large proximal gastric pouch , which had characterized the 19 gastric bypass operations done prior to May 1977 . The weight loss achieved with the current version of the gastric bypass , a smaller proximal gastric pouch , is comparable to that achieved with jejunoileal bypass . The objective and subjective sequelae and complications of jejunoileal bypass are more common and more serious than those of gastric bypass . Gastric bypass is the better operation for the treatment of morbid obesity Background : Laparoscopic adjustable gastric b and ing ( LAGB ) and open vertical b and ed gastroplasty ( VBG ) are treatment modalities for morbid obesity . However , few prospect i ve r and omized clinical trials ( RCT ) have been performed to compare both operations . Methods : 100 patients ( 50 per group ) were included in the study . Postoperative outcomes included hospital length of stay ( LOS ) , complications , percent excess weight loss ( % EWL ) , BMI and reduction in total comorbidities . Follow-up in all patients was 2 years . Results : LOS was significantly shorter in the LAGB group . 3 LAGB were converted to open ( 1 to gastric bypass ) . Directly after VBG , 3 patients needed relaparotomies due to leakage , of which one ( 2 % ) died . After 2 years , 100 % follow-up was achieved . BMI and % EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group ( 31.0 kg/m2 and 70.1 % vs 34.6 and 54.9 % respectively ) . Co-morbidities significantly decreased in both groups in time . 2 years after LAGB , 20 patients needed reoperation for pouch dilation/slippage ( n=12 ) , b and leakage ( n=2 ) , b and erosion ( n=2 ) and access-port problems ( n=4 ) . In the VBG group , 18 patients needed revisional surgery due to staple-line disruption ( n=15 ) , narrow outlet ( n=2 ) or insufficient weight loss ( n=1 ) . Furthermore , 8 VBG patients developed an incisional hernia . Conclusion : This RCT demonstrates that , despite the initial better weight loss in the VBG group , based on complication rates and clinical outcome , LAGB is preferred . It had a shorter LOS and less postoperative morbidity A prospect i ve r and omized clinical trial was undertaken to compare the effects of gastric bypass with Roux-en-Y gastro-jejunostomy and a gastric partitioning procedure . Operative groups were comparable , with regard to preoperative weight , age , sex , historic findings and operative complications . Postoperative weight loss was followed for one year . Patients receiving the gastric partitioning procedure showed significantly poorer weight loss as early as three months postoperatively than did those receiving gastric bypass . This poorer performance persisted throughout the study period Background : Bariatric surgery is currently the most effective treatment in morbidly obese patients , leading to durable weight loss . Objective : In this prospect i ve double blind study , we aim to evaluate and compare the effects of laparoscopic Roux-en-Y gastric bypass ( LRYGBP ) with laparoscopic sleeve gastrectomy ( LSG ) on body weight , appetite , fasting , and postpr and ial ghrelin and peptide-YY ( PYY ) levels . Methods : After r and omization , 16 patients were assigned to LRYGBP and 16 patients to LSG . Patients were reevaluated on the 1st , 3rd , 6th , and 12th postoperative month . Blood sample s were collected after an overnight fast and in 6 patients in each group after a st and ard 420 kcal mixed meal . Results : Body weight and body mass index ( BMI ) decreased markedly ( P < 0.0001 ) and comparably after either procedure . Excess weight loss was greater after LSG at 6 months ( 55.5 % ± 7.6 % vs. 50.2 % ± 6.5 % , P = 0.04 ) and 12 months ( 69.7 % ± 14.6 % vs. 60.5 % ± 10.7 % , [ P = 0.05 ] ) . After LRYGBP fasting ghrelin levels did not change significantly compared with baseline ( P = 0.19 ) and did not decrease significantly after the test meal . On the other h and , LSG was followed by a marked reduction in fasting ghrelin levels OUTPUT:

Bariatric surgery appears efficacious compared to st and ard care in reducing BMI . Weight losses are greatest with diversionary procedures , intermediate with diversionary/restrictive procedures , and lowest with those that are purely restrictive . Compared with Roux-en-Y gastric bypass , adjustable gastric b and ing has lower weight loss efficacy , but also leads to fewer serious adverse effects

MS2_dynamic_1_shot79

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This study was done to evaluate the effectiveness of transdermal nitroglycerin in the treatment of erectile dysfunction in males with spinal cord lesions as compared to the treatment with intracavernous injection of papaverine . The study design used was an open , r and omized , cross over trial of intracavernous injection papaverine versus transdermal nitroglycerin . Twenty eight male patients with spinal cord lesions with erectile dysfunction were included in the study , and were subjected to intracavernous injection of papaverine and transdermal nitroglycerin with an interval of 2 weeks as the wash out period . Objective ly , the times taken for the onset and the duration of erection were noted . The length of the penis and its circumference at its base were measured at intervals until the erection subsided . The volume of the penis at the onset and at the peak of erection was calculated . Twenty six patients ( ie 93 % ) who received an injection of papaverine , and 17 ( ie 61 % ) of the patients who received nitroglycerin showed a complete response . The difference was statistically significant ( P=0.004 ) . Nine ( 32 % ) patients had complications with the injection of papaverine . The only complication noted with the application of a nitroglycerin patch was mild headache , experienced by six ( 21 % ) patients . It was concluded from the study that intracavernous injection of papaverine is more effective than transdermal nitroglycerin in the treatment of erectile dysfunction in patients with spinal cord lesions Study design : This was a two-part pilot study in men with erectile dysfunction ( ED ) due to spinal cord injury ( SCI : cord level range T6-L5 ) . Part I was a r and omised , double-blind , two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo . Part II was a r and omised , double-blind , parallel-group evaluation of sildenafil 50 mg or placebo , taken as required ( not more than once daily ) approximately 1 h prior to sexual activity , over a period of 28 days . Objectives : To assay the efficacy and safety of sildenafil 50 mg and placebo . Setting : Clinic- and home-based assessment s in the United Kingdom . Methods : A total of 27 subjects who were able to achieve at least a grade 2 erection ( hard , but not hard enough for penetration ) in response to penile vibratory stimulation ( PVS ) were recruited . In Part I , the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II , the response to treatment was assessed in the home ( global efficacy , question niare , diary ) . Results : In Part I , 17/26 ( 65 % ) subjects had erections of > 60 % rigidity at the penile base ( median duration 3.5 min ) after sildenafil compared with 2/26 ( 8 % ) ( median duration 0 min ) after placebo ( P=0.0003 ) . In Part II , 9/12 ( 75 % ) subjects on sildenafil and 1/14 ( 7 % ) subjects on placebo reported that the treatment had improved their erections ( P<0.005 ) , and 8/12 ( 67 % ) and 2/13 ( 15 % ) men , respectively , indicated that they wished to continue treatment ( P<0.02 ) . An analysis of diary data showed no difference between the groups with respect to the mean number of erections hard enough for penetration ( P=0.08 ) . The mean proportion of attempts at sexual intercourse that were successful was 30 and 15 % , respectively ( P=0.21 ) . Similarly , responses to the end-of-treatment question naire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse ( P=0.47 ) or that lasted as long as the subject would have liked ( P=0.11 ) . No subject discontinued sildenafil due to adverse events . Conclusion : Sildenafil is an effective , well-tolerated oral treatment for ED in SCI subjects . Sponsorship : This study was funded by Pfizer Study design : Multicenter , open , prospect i ve , before-after study . Objective : To assess the efficacy and safety of sildenafil therapy for erectile dysfunction in patients with spinal cord injury , and the association between the response to sildenafil and factors such as causes and levels of spinal cord injury , grade of ASIA deficit , time since injury , orgasmic perception , and degree of baseline erection . Setting : Homes of out patients of 16 spinal cord injury units in Spain . Method : One hundred and seventy patients with erectile dysfunction secondary to spinal cord injury , from whom baseline data were collected on their sexual function , and who started treatment with sildenafil 50 mg . An efficacy assessment was made by the patient and his partner , and the score of the International Index of Erectile Function ( IIEF ) was recorded . Results : It was reported by 88.2 % of the patients and 85.3 % of their partners that treatment with sildenafil had improved their erections , regardless of the baseline characteristics of the spinal cord injury and erectile function . In responders , this improvement was confirmed by an increase from 12.5 to 24.8 points ( P<0.001 ) of the Erectile Function Domain of IIEF . A significant improvement was also seen in patients ' satisfaction with sexual activity and general satisfaction derived from sexual life . Preservation of orgasmic perception and a baseline degree of erection of 3 or 4 ( P=0.006 ) were predictors of therapeutic success . No serious adverse events occurred . Conclusion : Sildenafil is an effective , well-tolerated treatment for erectile dysfunction caused by spinal cord injury , regardless of the cause , neurological level , ASIA grade , and time since injury . Sponsorship : Spanish Society of Paraplegia . Spinal Cord ( 200 OUTPUT: Conclusions : A large body of evidence addressing sexuality in males focuses on erection . Penile injection , sildenafil and vacuum devices generally obviate the need for penile implants to address erectile dysfunction . Interventions may positively affect sexual activity in the short term . INPUT: Abstract Objectives : Approximately one third to one half of the penis is embedded in the pelvis and can be felt through the scrotum and in the perineum . The main arteries and nerves enter the penis through this perineal part of the penis , which seems to represent a highly sensitive area . We investigated the hypothesis that percutaneous perineal stimulation evokes erection in patients with neurogenic erectile dysfunction . Methods : Percutaneous electrostimulation of the perineum ( PESP ) with synchronous intracorporeal pressure ( ICP ) recording was performed in 28 healthy volunteers ( age 36.3 ± 7.4 y ) and 18 patients ( age 36.6 ± 6.8 y ) with complete neurogenic erectile dysfunction ( NED ) . Current was delivered in a sine wave summation fashion . Average maximal voltages and number of stimulations delivered per session were 15 to 18 volts and 15 to 25 stimulations , respectively . Results : PESP of healthy volunteers effected an ICP increase ( P < 0.0001 ) , which returned to the basal value upon stimulation cessation . The latent period recorded was 2.5 ± 0.2 seconds . Results were reproducible on repeated PESP in the same subject but with an increase of the latent period . Patients with NED recorded an ICP increase that was lower ( P < 0.05 ) and a latent period that was longer ( P < 0.0001 ) than those of healthy volunteers . Conclusion : PESP effected ICP increase in the healthy volunteers and patients with NED . The ICP was significantly higher and latent period shorter in the healthy volunteers than in the NED patients . PESP may be of value in the treatment of patients with NED , provided that further studies are performed to reproduce these results Our experience with intracavernous injection of prostagl and in E1 in spinal cord injured patients with neurogenic erectile dysfunction included 15 men . They received testing dosage starting from 5 µg with increasing dosage ( maximum 20 µg ) to achieve a rigid erection of Schramek 's grade 5 and lasting for at least 20 min . All of them had achieved functional erection adequate for coitus after treatment except one patient who had been proved to have venogenic impotence . We found that intracavernous injection of prostagl and in E1 had significantly improved the erectile condition . No systemic side effect or any other complication was noted except that pain at the injection site was complained of in two patients with incomplete lesion Abstract Background / objective : To show the efficacy , safety , and tolerability of sildenafil in men with erectile dysfunction ( ED ) associated with complete or incomplete spinal cord injury ( SCI ) and to assess its effects on quality of life ( Qol ) using the Life-Satisfaction Check List . Methods : This was a placebo-controlled , multicenter , r and omized , double-blind , flexible-dose , 2-way crossover study with a 2-week washout period between each phase . Patients with ED attributable to SCI(Sexual Health Inventory-Male score ≤21 ) received 50 to 100 mg sildenafil ( n = 24 ) or placebo ( n = 26 ) . Results : Compared with placebo , sildenafil produced higher levels of successful sexual stimulation , intercourse success , satisfaction with sexual life and sexual relationship , erectile function , overall sexual satisfaction , and an improved Erectile Dysfunction Inventory of Treatment Satisfaction score , with no clinical ly relevant effects onvital signs . Sildenafil seemed more effective in patients with incomplete SCI than in those with complete SCI , producing significant improvements , compared with placebo , in a number of measures only in patients with incomplete SCI . All patients who expressed a preference selected sildenafil over placebo , although the drug had no effect on patient Qol . Sildenafil was well tolerated , with a profile comparable to that of placebo . Conclusions : Compared with placebo , treatment with oral sildenafil safely and effectively improved erectile function in patients with ED attributable to SCI , especially in those with incomplete injury , and was theagent of choice in those who expressed a preference AIM Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction ( ED ) . Efficacy of vardenafil has been demonstrated in various ED population s , but that in Japanese patients with spinal cord injury ( SCI ) has not been assessed . METHODS This was an open-label , multicenter , flexible dose , 12-week study in patients with ED due to SCI . Following a 4-week observation period , patients received vardenafil 10 mg for 4 weeks , and based on efficacy , tolerability and patient preference , doses for the remaining 8 weeks were decided by investigators . The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function . RESULTS Ten patients took 10 mg all through the study , while 22 patients took 20 mg after completing 4 weeks ' treatment with 10 mg . The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward ( LOCF ) in the former group and from 10.3 to 22.5 in the latter group , respectively . Importantly , there was a 5.0 point increase in erectile function domain score after up-titration in the latter group . Drug-related adverse events were observed in 22 % of patients including hot flushes ( 9 % ) and headache ( 6 % ) , but these were transient and mild in intensity . Serious adverse events and adverse events leading to discontinuation of the study drug were not reported . CONCLUSIONS Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI . Of interest , erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg Sildenafil ( Viagra , UK-9 OUTPUT:

Conclusions : This systematic review and meta- analysis indicate that PDE5 inhibitors are effective and well tolerated to treat ED secondary to SCI compared with placebo , as measured by response to GEQ , SEP2 , SEP3 and incidence of adverse events . PDE5 inhibitors could be considered as the first choice in the treatment of ED patients with SCI

MS2_dynamic_1_shot80

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective : To prospect ively compare the functional outcome associated with cemented and uncemented hemiarthroplasty . Design : Prospect i ve r and omized control trial . Setting : University-affiliated level 1 trauma center . Patients / Participants : All individuals design ated for hemiarthroplasty , older than 55 years , with a nonpathologic displaced femoral neck fracture and the ability to ambulate 10 feet independently before injury [ 269 patients ( 274 hips ) presented with displaced femoral neck fracture , 130 patients ( 48.3 % ) enrolled , and 5 patients ( 3.8 % ) withdrew ] . Intervention : Hip hemiarthroplasty with a cemented femoral prosthesis ( VerSys LD/Fx ; Zimmer , Warsaw , IN ) or an uncemented component ( VerSys Beaded FullCoat ; Zimmer , Warsaw , IN ) . Main Outcome Measures : Instrumental Activities of Daily Living and Physical Activities of Daily Living scales ( Older Americans Re sources and Services Instrument ) and the Energy/Fatigue Scale . Results : No statistically significant differences were present in the groups ' preoperative or intraoperative characteristics , including American Society of Anesthesiologists grade , operative time , anesthesia time , use of perioperative & bgr;-blockers , estimated blood loss , or the rate of intraoperative fracture . Postoperatively , no difference was found in hemoglobin level , transfusion rate , discharge disposition , or acute complication rate . At 30-day , 60-day , and 1-year follow-ups , no clinical ly or statistically significant differences were found in mortality , disposition , need for assistance with ambulation , Older Americans Re sources and Services Activities of Daily Living subscales , or the Energy/Fatigue Scale . Conclusions : In the treatment of nonpathologic displaced femoral neck fractures , the use of cemented and uncemented femoral components is associated with similar functional outcome at 1 year . Practitioners may inform their clinical decisions using these equally good results . Level of Evidence : Therapeutic Level II . See page 128 for a complete description of levels of evidence Hip hemiarthroplasties are frequently performed for displaced femoral neck fractures . The purpose of this study was to identify the costs associated with cementless and cemented hemiarthroplasties , compare operative times , and identify complications . The hypothesis was that cementless hemiarthroplasties cost less than cemented hemiarthroplasties , require less operative time , and have fewer perioperative complications . A retrospective review was conducted of 2 surgeons ' patients admitted for displaced femoral neck fractures between 2006 and 2010 . Group 1 included 45 patients who underwent monopolar hemiarthroplasties with cementless femoral components via a st and ard posterior approach by a single surgeon . Group 2 included 49 patients who underwent monopolar hemiarthroplasties with cemented femoral components via a modified lateral approach by a single surgeon . Surgical and anesthesia times and the cost of implants and accessories were recorded . The cost for cementless components was $ 3275.60 ( femoral stem , $ 2800 ; monopolar head , $ 400 ; sleeve , $ 75.60 ) , whereas the cost of cemented components was $ 3694.47 ( femoral stem , $ 1800 ; monopolar head , $ 400 ; sleeve , $ 75.60 , 3 Simplex with tobramycin cement packets , $ 1221 ; cement mixer/irrigator with tip/ central izer and plug/pressurizer , $ 197.87 ) , a cost savings of 12.7 % ( $ 418.87 ) . Operative time was significantly reduced in group 1 vs group 2 ( mean , 32.9 vs 56.1 minutes , respectively ; P<.01 ) . Anesthesia time was also significantly reduced in group 1 ( mean , 82.3 vs 102.9 minutes , respectively ; P<.01 ) . The difference in mean anesthetic times demonstrates an overall cost savings of 18.6 % , or $ 1161.30 . No difference in complications was noted between the groups perioperatively . Regional cost variances , vendor-hospital contracts , and surgeons ' operative times are factors that may influence cost savings . This study demonstrates significantly lower operative and anesthetic times and observable cost savings with cementless femoral implants Background Displaced femoral neck fractures usually are treated with hemiarthroplasty . However , the degree to which the design of the implant used ( cemented or uncemented ) affects the outcome is not known and may be therapeutically important . Questions / purpose sIn this r and omized controlled trial , we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of ( 1 ) Harris hip scores ; ( 2 ) femoral fractures ; ( 3 ) overall health outcomes using the Barthel Index and EQ-5D scores ; and ( 4 ) complications , reoperations , and mortality since our earlier report on this cohort at 1-year followup . Methods We present followup at a median of 5 years after surgery ( range , 56–65 months ) from a r and omized trial comparing a cemented hemiarthroplasty ( 112 hips ) with an uncemented , hydroxyapatite-coated hemiarthroplasty ( 108 hips ) , both with a bipolar head . Results were previously reported at 1-year followup . Harris hip scores , Barthel Index , and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon . Complications and reoperations were determined by chart review and radiographs examined by OUTPUT: There was no statistically significant difference for any other outcome between the two methods of fixation . Conclusion In hemiarthroplasty of the hip using current generation stems , cemented stems result in fewer implant‐related complications and similar mortality compared with cementless stems INPUT: Background In uncemented total hip arthroplasty with hydroxyapatite coating , early weight bearing is frequently practice d but there is still not much evidence to support this recommendation . Method In a prospect i ve r and omized study we evaluated the effect of partial and full weight bearing after cementless total hip arthroplasty ( ABG ; Stryker-Howmedica ) using radiostereometric analysis ( RSA ) . Between February 1996 and February 2000 , 43 consecutive patients ( mean age 53 ( 41–63 ) years , 23 women ) with hip osteoarthrosis received an uncemented and hydroxyapatite-coated prosthesis with an anteverted stem . All patients were operated in a st and ardized way by three experienced surgeons and they were r and omized to partial ( P ) or full ( F ) weight bearing during the first 6 weeks after surgery . The patients in the partial weight bearing group were equipped with a pressuresensitive insole signaling when their load exceeded the prescribed weight limit . Results At 3-month follow-up , the mean proximal (+)/ distal ( - ) migration of the stem was -0.14 mm ( -1.93– 0.11 ) in group P and -0.31 mm ( -4.30–0.16 ) in group F ( p = 0.6 ) . At 1-year follow-up , the mean migration was –0.17 mm ( -2.18–0.21 ) and -0.28 mm ( -4.31–0.11 ) , respectively ( p = 0.9 ) . There was no significant difference in stem rotations either ( p < 0.2 ) . The cup translations , rotations , and femoral head penetration were similar in the two groups ( p < 0.1 ) . There were no re-operations during the first year . Interpretation We did not find any adverse effect of full weight bearing immediately after operation , which justifies use of this regimen after uncemented total hip arthroplasty of the ABG type We performed this investigation to determine the possible migration starting immediately after surgery and the effect of different weightbearing regimens on the migration pattern of an uncemented hip stem ( CLS ) . Stem migration was determined with radiostereometry analysis with baseline when the patients still were anesthetized . Subsequent examinations were done up to 1 year . Twenty-nine patients ( mean age , 55 years ; range , 26 - 63 years ) were r and omized to either unrestricted weightbearing combined with intensive physiotherapy from the first day after surgery or to partial weightbearing and a conservative training regimen for the first 3 months after surgery . At 1 week , subsidence was −0.03 mm in the unrestricted weightbearing group and 0.01 mm in the partial weightbearing group . At 1 year , subsidence was 1.01 mm in the unrestricted weightbearing group and 0.51 mm in the partial weightbearing group . One patient in the unrestricted weightbearing group had revision surgery because of aseptic loosening at 1.5 years after surgery . The CLS stem did not have any migration from the end the surgery until 1 week , but there was small migration from 1 week to 3 months after which the stem remained stable . The degree of early weightbearing did not affect the migration pattern . Level of Evidence : Level I , therapeutic study ( r and omized study ) . See the Guidelines for Authors for a complete description of levels of evidence Abstract . In a prospect i ve study of cementless total hip arthroplasty , 19 hips in 17 patients ( Group A ) were allowed full weight-bearing immediately after the operation while 18 hips in 16 patients ( Group B ) were first allowed weight-bearing after 6 weeks . Patients were matched for sex , age at surgery , height , weight , and follow-up period and there were no significant differences in hip scores between the two groups . Rehabilitation to gain walking ability with a cane lasted 5.8 days for Group A and 44.8 days for Group B ( P=0.0001 ) . The hospital stay after surgery was 30.1 days for Group A and 46.7 days for Group B ( P=0.006 ) . All patients showed bone ingrowth radiographically . There were no complications in either group . Résumé . Dans une étude prospect i ve d'arthroplastie totale de la hanche non-cimentée , z 17 malades ( 19 hanches ) ( Groupe A ) ont eu l'autorisation de pratiquer un appui complet immédiatement après l'intervention t and is que 16 malades ( 18 hanches ) ( Groupe B ) l'ont fait après 6 semaines . Les malades ont été appariés en regard du sexe , de l'âge à la chirurgie , de la taille , du poids , et de la durée du suivi . Il n'y avait pas de différence significative en ce qui concerne les scores du fonctionnement de la hanche entre les deux groupes . La durée de rééducation nécessaire pour obtenir la capacité de marche à l'aide d'une canne était de 5,8 jours pour le Groupe A et de 44,8 jours pour Groupe B ( P=0.0001 ) . La durée de séjour à l'hôpital après l'intervention était de 30,1 jours pour le Groupe A et de 46,7 jours pour le Groupe B ( P=0.006 ) . Nous avons constaté chez tous les patients une fixation osseuse à la radiographie . Il n'y avait aucune complication dans les deux groupes The vertical migration of four configurations of a proximal femoral prosthesis , followed for up to nine years , was measured on st and ard radiographs . The same implant was used without cement ( group 1 ) and with cement ( group 2 ) . The migration of both groups was linear from six months onwards . The mean migration rate and the incidence of late aseptic OUTPUT:

We found moderate to strong evidence that no adverse effects on subsidence and osseous integration of the femoral stem after uncemented THA occur after immediate UWB .

MS2_dynamic_1_shot81

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND AND PURPOSE Although the efficacy of anticoagulant therapy for primary prevention of stroke in patients with nonvalvular atrial fibrillation ( NVAF ) has been established , efficacy of antiplatelet therapy for low-risk patients is disputable in Japanese patients because of the frequent hemorrhagic complications . We examined the efficacy and safety of aspirin therapy in Japanese patients with NVAF in a prospect i ve r and omized multicenter trial . METHODS Patients with NVAF were r and omized to an aspirin group ( aspirin at 150 to 200 mg per day ) or a control group without antiplatelet or anticoagulant therapy . Primary end points included cardiovascular death , symptomatic brain infa rct ion , or transient ischemic attack . RESULTS A total of 426 patients were r and omized to aspirin group and 445 to no treatment . The trial was stopped earlier because there were 27 primary end point events ( 3.1 % per year ; 95 % CI , 2.1 % to 4.6 % per year ) in the aspirin group versus 23 ( 2.4 % per year ; 95 % CI , 1.5 % to 3.5 % per year ) in the control group , suggesting a low possibility of superiority of the aspirin treatment for prevention of the primary end point . In addition , treatment with aspirin caused a marginally increased risk of major bleeding ( 7 patients ; 1.6 % ) compared with the control group ( 2 patients ; 0.4 % ; Fisher exact test P=0.101 ) . CONCLUSIONS For prevention of stroke in patients with NVAF , aspirin at 150 to 200 mg per day does not seem to be either effective or safe . Further prospect i ve studies are needed to determine the best preventive therapy for cerebrovascular events in Japanese patients with NVAF AIMS The Bleeding Academic Research Consortium ( BARC ) classification has been proposed by consensus to st and ardize bleeding endpoint definition and reporting in cardiovascular clinical trials . There are no prospect i ve studies on its prognostic impact . METHODS AND RESULTS We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two vali date d bleeding scales : the Thrombolysis in Myocardial Infa rct ion ( TIMI ) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries ( GUSTO ) scales . Non-coronary artery bypass graft (CABG)-related bleedings within the PRODIGY trial were prospect ively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling . At 2 years , bleeding occurred in 143 patients ( 7.1 % ) according to BARC Type 2 , 3 , or 5 ; in 50 patients ( 2.5 % ) according to TIMI minor or major ; and in 61 patients ( 3.1 % ) according to GUSTO moderate or severe . One hundred sixty-three patients died ( 8.1 % ) . After multivariable modelling , BARC Type 2 , 3 , or 5 bleeding was associated with increased 2-year mortality [ hazard ratio ( HR ) : 3.77 ; 95 % confidence interval ( CI ) : 2.37 - 5.98 ] . Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years ( adjusted HR : 7.72 ; 95 % CI : 4.75 - 12.54 ) similar to that provided by TIMI ( HR : 7.64 , 95 % CI : 4.53 - 12.87 ) or GUSTO ( HR : 7.36 , 95 % CI : 4.38 - 12.34 ) criteria . CONCLUSIONS In a contemporary , all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales BACKGROUND atrial fibrillation ( AF ) is the commonest chronic arrhythmia with a prevalence of 9 % in octogenarians and accounts for 24 % of the stroke risk in this population . Although trials demonstrate reductions in stroke with warfarin , audit data show that it is still underused . However , anti-coagulation in the very elderly is not without risk . METHODS r and omised open labelled prospect i ve study of primary thromboprophylaxis for AF . Patients aged > 80 and < 90 were r and omised to receive dose-adjusted warfarin ( INR 2.0 - 3.0 ) or aspirin 300 mg . All patients had permanent AF , were ambulant , had Folstein mini mental score > 25 and had no contraindications to either treatment . Follow-up was for 1 year with 3 monthly visits . The primary outcome measure was a comparative frequency of combined endpoints comprising death , thromboembolism , serious bleeding and withdrawal from the study . RESULTS seventy-five patients ( aspirin 39 ; warfarin 36 ) were entered ( mean age 83.9 , 47 % male ) . There were significantly more adverse events with aspirin ( 13/39 ; 33 % ) than warfarin ( 2/36 ; 6 % ) , P = 0.002 . 10/13 aspirin adverse events were caused by side effects and serious bleeding ; there were three deaths ( two aspirin , one warfarin ) . CONCLUSION dose-adjusted warfarin was significantly better tolerated with fewer adverse events than aspirin 300 mg in this elderly population . Although aspirin OUTPUT: Cluster rank plot incorporating stroke and major bleeding outcomes indicates that some warfarin care bundles perform as well as NOACs . Both interventions are therefore viable options to be considered for SPAF . INPUT: BACKGROUND AND PURPOSE Although the efficacy of anticoagulant therapy for primary prevention of stroke in patients with nonvalvular atrial fibrillation ( NVAF ) has been established , efficacy of antiplatelet therapy for low-risk patients is disputable in Japanese patients because of the frequent hemorrhagic complications . We examined the efficacy and safety of aspirin therapy in Japanese patients with NVAF in a prospect i ve r and omized multicenter trial . METHODS Patients with NVAF were r and omized to an aspirin group ( aspirin at 150 to 200 mg per day ) or a control group without antiplatelet or anticoagulant therapy . Primary end points included cardiovascular death , symptomatic brain infa rct ion , or transient ischemic attack . RESULTS A total of 426 patients were r and omized to aspirin group and 445 to no treatment . The trial was stopped earlier because there were 27 primary end point events ( 3.1 % per year ; 95 % CI , 2.1 % to 4.6 % per year ) in the aspirin group versus 23 ( 2.4 % per year ; 95 % CI , 1.5 % to 3.5 % per year ) in the control group , suggesting a low possibility of superiority of the aspirin treatment for prevention of the primary end point . In addition , treatment with aspirin caused a marginally increased risk of major bleeding ( 7 patients ; 1.6 % ) compared with the control group ( 2 patients ; 0.4 % ; Fisher exact test P=0.101 ) . CONCLUSIONS For prevention of stroke in patients with NVAF , aspirin at 150 to 200 mg per day does not seem to be either effective or safe . Further prospect i ve studies are needed to determine the best preventive therapy for cerebrovascular events in Japanese patients with NVAF BACKGROUND To test the use of three lead monitoring as a screening tool for atrial fibrillation ( AF ) in general practice . AF is responsible for up to a quarter of all strokes and is often asymptomatic until a stroke occurs . METHODS 26 r and omly selected general practice s identified 80 r and omly selected patients aged 70 or older from their data base and excluded those known to have AF , those with clinical issues or who had not attended for three years . Up to 40 eligible patients / practice were invited to attend for screening . A 2min three-lead ECG was recorded and collected central ly for expert cardiology assessment . Risk factor data was gathered . OUTCOMES ( i ) point prevalence of AF , ( ii ) proportion of ECG tracings which were adequate for interpretation , ( iii ) uptake rate by patients and ( iv ) acceptability of the screening process to patients and staff ( reported separately ) . RESULTS Of 1447 current patients , 1003 were eligible for inclusion , 639 ( 64 % ) agreed to take part in screening and 566 ( 56 % ) completed screening . The point prevalence rate for AF was 10.3%-2.1 % new cases ( 12 of 566 who were screened ) and 9.5 % existing cases ( 137 of 1447 eligible patients ) . Only four of 570 ( 0.7 % ) screening visits did not record a usable ECG and 11 ( 2.6 % ) three lead ECGs required a clarifying 12 lead ECG . CONCLUSIONS Three lead screening for AF is feasible , effective and offers an alternative to pulse taking or 12 lead ECGs . The availability of this technology may facilitate more effective screening , leading to reduced stroke incidence Objectives To assess whether screening improves the detection of atrial fibrillation ( cluster r and omisation ) and to compare systematic and opportunistic screening . Design Multicentred cluster r and omised controlled trial , with subsidiary trial embedded within the intervention arm . Setting 50 primary care centres in Engl and , with further individual r and omisation of patients in the intervention practice s. Participants 14 802 patients aged 65 or over in 25 intervention and 25 control practice s. Interventions Patients in intervention practice s were r and omly allocated to systematic screening ( invitation for electrocardiography ) or opportunistic screening ( pulse taking and invitation for electrocardiography if the pulse was irregular ) . Screening took place over 12 months in each practice from October 2001 to February 2003 . No active screening took place in control practice s. Main outcome measure Newly identified atrial fibrillation . Results The detection rate of new cases of atrial fibrillation was 1.63 % a year in the intervention practice s and 1.04 % in control practice s ( difference 0.59 % , 95 % confidence interval 0.20 % to 0.98 % ) . Systematic and opportunistic screening detected similar numbers of new cases ( 1.62 % v 1.64 % , difference 0.02 % , −0.5 % to 0.5 % ) . Conclusion Active screening for atrial fibrillation detects additional cases over current practice . The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography . Trial registration Current Controlled Trials IS RCT N19633732 INTRODUCTION AND OBJECTIVES Atrial fibrillation constitutes a serious public health problem because it can lead to complications . Thus , the management of this arrhythmia must include not only its treatment , but antithrombotic therapy as well . The main goal is to determine the proportion of cases of undiagnosed atrial fibrillation and the proportion of patients not being treated with oral anticoagulants . METHODS A multicenter , population -based , retrospective , cross-sectional , observational study . In all , 1043 participants over 60 years of age were r and omly selected to OUTPUT:

Conclusions and Relevance Although screening with ECG can detect previously unknown cases of atrial fibrillation , it has not been shown to detect more cases than screening focused on pulse palpation . Treatments for atrial fibrillation reduce the risk of stroke and all-cause mortality and increase the risk of bleeding , but trials have not assessed whether treatment of screen-detected asymptomatic older adults results in better health outcomes than treatment after detection by usual care or after symptoms develop

MS2_dynamic_1_shot82

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Objective To evaluate the effects of water versus beverages sweetened with non‐nutritive sweeteners ( NNS ) on body weight in subjects enrolled in a year‐long behavioral weight loss treatment program . Methods The study used a r and omized equivalence design with NNS or water beverages as the main factor in a trial among 303 weight‐stable people with overweight and obesity . All participants participated in a weight loss program plus assignment to consume 24 ounces ( 710 ml ) of water or NNS beverages daily for 1 year . Results NNS and water treatments were non‐equivalent , with NNS treatment showing greater weight loss at the end of 1 year . At 1 year subjects receiving water had maintained a 2.45 ± 5.59 kg weight loss while those receiving NNS beverages maintained a loss of 6.21 ± 7.65 kg ( P < 0.001 for difference ) . Conclusions Water and NNS beverages were not equivalent for weight loss and maintenance during a 1‐year behavioral treatment program . NNS beverages were superior for weight loss and weight maintenance in a population consisting of regular users of NNS beverages who either maintained or discontinued consumption of these beverages and consumed water during a structured weight loss program . These results suggest that NNS beverages can be an effective tool for weight loss and maintenance within the context of a weight management program BACKGROUND The rising prevalence of obesity in children has been linked in part to the consumption of sugar-sweetened drinks . Our aim was to examine this relation . METHODS We enrolled 548 ethnically diverse schoolchildren ( age 11.7 years , SD 0.8 ) from public schools in four Massachusetts communities , and studied them prospect ively for 19 months from October , 1995 , to May , 1997 . We examined the association between baseline and change in consumption of sugar-sweetened drinks ( the independent variables ) , and difference in measures of obesity , with linear and logistic regression analyses adjusted for potentially confounding variables and clustering of results within schools . FINDINGS For each additional serving of sugar-sweetened drink consumed , both body mass index ( BMI ) ( mean 0.24 kg/m2 ; 95 % CI 0.10 - 0.39 ; p=0.03 ) and frequency of obesity ( odds ratio 1.60 ; 95 % CI 1.14 - 2.24 ; p=0.02 ) increased after adjustment for anthropometric , demographic , dietary , and lifestyle variables . Baseline consumption of sugar-sweetened drinks was also independently associated with change in BMI ( mean 0.18 kg/m2 for each daily serving ; 95 % CI 0.09 - 0.27 ; p=0.02 ) . INTERPRETATION Consumption of sugar-sweetened drinks is associated with obesity in children Dietary compensation for energy provided as ethanol is reportedly limited . Whether this is a function of the ethanol or other aspect of the medium in which it is ingested is not known . Eight male and eight female adults ingested 1.08 liters of beer ( 5.0 % ethanol w/v , 1891kJ ) , light beer ( 2.9 % ethanol w/v , 1197kJ ) , no-alcohol beer ( 0.1 % ethanol w/v , 816kJ ) , cola ( 1749kJ ) or carbonated water ( 0kJ ) every 3 - 4 days with a midday meal . Diet records were kept the preceding day and day of beverage ingestion . Energy intake was significantly higher each day an energy-bearing beverage was consumed relative to its preceding day . A literature review revealed dietary compensation for modifications of energy intake via fluids is less precise than when solid foods are manipulated . These findings demonstrate dietary adjustment for energy derived from ethanol is imprecise , but also indicate energy from carbohydrate elicits little dietary response when ingested in a beverage Whereas soft drinks are described as primarily thirst-quenching liquids , juices and milk are said to be liquid foods , with a greater satiating power . This study was conducted to compare the effects of orange juice , low-fat milk ( 1 % ) , regular cola , and sparkling water on hunger , thirst , satiety , and energy intakes at the next meal . Thirty-two volunteers ( 14 men and 18 women ) , ages 18 - 35 years , consumed a breakfast preload composed of 590 ml ( 20 oz ) of an energy-containing beverage ( 1036 kJ ) or water ( 0 kJ ) and a slice of toast ( 418 kJ ) on four different occasions . Participants rated hunger , thirst , fullness , and desire to eat at baseline and at 20-min intervals for 2 h following preload ingestion . A tray lunch was presented at 2 h , 15 min and food consumption was measured . Compared to sparkling water , the three energy-containing beverages were associated with higher fullness and reduced hunger rating and desire to eat . However , energy intakes at lunch ( 4511+/-151 kJ for men and 3183+/-203 kJ for women ) were the same across all four beverage conditions and no compensation for breakfast energy was observed . The three beverages of equal energy value were significantly different from sparkling water , but not from each other , in their effects on hunger and satiety ratings . All four beverages satisfied thirst equally well . Whether energy-containing cola , juice , and low-fat milk facilitate a positive energy balance remains a topic for further study Objective The present study evaluated weight loss and compliance outcomes for overweight adolescents assigned to one of two dietary interventions differing in the type of snacks allowed . Methods The study was a 12-week , controlled clinical trial , among otherwise healthy but overweight ( body mass index ≥95th percent OUTPUT: The most effective intervention among the studies was the replacement of caloric beverages with water . In conclusion , despite 5.15 % of weight loss , the low to moderate quality of evidence and the short term of follow-up are limitations to support evidence -based recommendations of water consumption for weight loss INPUT: Objective To evaluate the effects of water versus beverages sweetened with non‐nutritive sweeteners ( NNS ) on body weight in subjects enrolled in a year‐long behavioral weight loss treatment program . Methods The study used a r and omized equivalence design with NNS or water beverages as the main factor in a trial among 303 weight‐stable people with overweight and obesity . All participants participated in a weight loss program plus assignment to consume 24 ounces ( 710 ml ) of water or NNS beverages daily for 1 year . Results NNS and water treatments were non‐equivalent , with NNS treatment showing greater weight loss at the end of 1 year . At 1 year subjects receiving water had maintained a 2.45 ± 5.59 kg weight loss while those receiving NNS beverages maintained a loss of 6.21 ± 7.65 kg ( P < 0.001 for difference ) . Conclusions Water and NNS beverages were not equivalent for weight loss and maintenance during a 1‐year behavioral treatment program . NNS beverages were superior for weight loss and weight maintenance in a population consisting of regular users of NNS beverages who either maintained or discontinued consumption of these beverages and consumed water during a structured weight loss program . These results suggest that NNS beverages can be an effective tool for weight loss and maintenance within the context of a weight management program To investigate whether obese women can compensate for sucrose added to the diet when it is given blind , rather than gaining weight or exhibiting dysfunctional regulation of intake , in the present study , forty-one healthy obese ( BMI 30–35 kg/m2 ) women ( age 20–50 years ) , not currently dieting , were r and omly assigned to consume sucrose ( n 20 ) or aspartame ( n 21 ) drinks over 4 weeks in a parallel single-blind design . Over the 4 weeks , one group consumed 4 × 250 ml sucrose drinks ( total 1800 kJ/d ) and the other group consumed 4 × 250 ml aspartame drinks . During the baseline week and experimental weeks , body weight and other biometric data were measured and steps per day , food intake using 7 d unweighed food diaries , and mood using ten- or seven-point Likert scales four times a day were recorded . At the end of the experiment , the participants weighed 1·72 ( se 0·47 ) kg less than the value predicted by the National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) model ; the predicted body weight accounted for 94·3 % of the variance in the observed body weight and experimental group accounted for a further 1·1 % of the variance in the observed body weight , showing that women consuming sucrose drinks gained significantly less weight than predicted . The reported daily energy intake did not increase significantly , and sucrose supplements significantly reduced the reported voluntary sugar , starch and fat intake compared with aspartame . There were no effects on appetite or mood . Over 4 weeks , as part of everyday eating , sucrose given blind in soft drinks was partially compensated for by obese women , as in previous experiments with healthy and overweight participants The long-term physiological effects of refined carbohydrates on appetite and mood remain unclear . Reported effects when subjects are not blind may be due to expectations and have rarely been studied for more than 24 h. The present study compared the effects of supplementary soft drinks added to the diet over 4 weeks on dietary intake , mood and BMI in normal-weight women ( n 133 ) . Subjects were categorised as ' watchers ' or ' non-watchers ' of what they ate then received sucrose or artificially sweetened drinks ( 4 x 250 ml per d ) . Expectancies were varied by labelling drinks ' sugar ' or ' diet ' in a counter-balanced design . Sucrose supplements provided 1800 kJ per d and sweetener supplements provided 67 kJ per d. Food intake was measured with a 7 d diary and mood with ten single Likert scales . By 4 weeks , sucrose supplements significantly reduced total carbohydrate intake ( F(1,129 ) = 53.81 ; P<0.001 ) , fat ( F(2,250 ) = 33.33 ; P<0.001 ) and protein intake ( F(2,250 ) = 28.04 ; P<0 - 001 ) compared with sweetener supplements . Mean daily energy intake increased by just under 1000 kJ compared with baseline ( t ( 67 df ) = 3.82 ; P < 0.001 ) and was associated with a non-significant trend for those receiving sucrose to gain weight . There were no effects on appetite or mood . Neither dietary restraint status as measured by the Dutch Eating Behaviour Question naire nor the expectancy procedure had effects . Expectancies influenced mood only during baseline week . It is concluded that sucrose satiates , rather than stimulates , appetite or negative mood in normal-weight subjects BACKGROUND The consumption of beverages that contain sugar is associated with overweight , possibly because liquid sugars do not lead to a sense of satiety , so the consumption of other foods is not reduced . However , data are lacking to show that the replacement of sugar-containing beverages with noncaloric beverages diminishes weight gain . METHODS We conducted an 18-month trial involving 641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age . Participants were r and omly assigned to receive 250 ml ( 8 oz ) per day of a sugar-free , artificially sweetened beverage ( sugar-free group ) or a similar sugar-containing beverage that provided 104 kcal ( sugar group ) . Beverages were distributed through schools . At 18 months , 26 % of the children had stopped consuming the beverages ; the data from children OUTPUT:

When comparing NNS vs sucrose , significant weight/ BMI differences appeared favouring NNS . Consumption of NNS led to significantly negative weight/ BMI differences in unrestricted energy diets , but not in weight-reduction diets . Participants with overweight/obesity and adults showed significant favourable weight/ BMI differences with NNS . Data suggest that replacing sugar with NNS leads to weight reduction , particularly in participants with overweight/obesity under an unrestricted diet , information that could be utilized for evidence -based public policy decisions

MS2_dynamic_1_shot83

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain Background It has been suggested that exercise training results in compensatory mechanisms that attenuate weight loss . However , this has only been examined with large doses of exercise . The goal of this analysis was to examine actual weight loss compared to predicted weight loss ( compensation ) across different doses of exercise in a controlled trial of sedentary , overweight or obese postmenopausal women ( n = 411 ) . Methodology /Principal Findings Participants were r and omized to a non-exercise control ( n = 94 ) or 1 of 3 exercise groups ; exercise energy expenditure of 4 ( n = 139 ) , 8 ( n = 85 ) , or 12 ( n = 93 ) kcal/kg/week ( KKW ) . Training intensity was set at the heart rate associated with 50 % of each woman 's peak VO2 and the intervention period was 6 months . All exercise was supervised . The main outcomes were actual weight loss , predicted weight loss ( exercise energy expenditure/ 7700 kcal per kg ) , compensation ( actual minus predicted weight loss ) and waist circumference . The study sample had a mean ( SD ) age 57.2 ( 6.3 ) years , BMI of 31.7 ( 3.8 ) kg/m2 , and was 63.5 % Caucasian . The adherence to the intervention was > 99 % in all exercise groups . The mean ( 95 % CI ) weight loss in the 4 , 8 and 12 KKW groups was −1.4 ( −2.0 , −0.8 ) , −2.1 ( −2.9 , −1.4 ) and −1.5 ( −2.2 , −0.8 ) kg , respectively . In the 4 and 8 KKW groups the actual weight loss closely matched the predicted weight loss of −1.0 and −2.0 kg , respectively , result ing in no significant compensation . In the 12 KKW group the actual weight loss was less than the predicted weight loss ( −2.7 kg ) result ing in 1.2 ( 0.5 , 1.9 ) kg of compensation ( P<0.05 compared to 4 and 8 KKW groups ) . All exercise groups had a significant reduction in waist circumference which was independent of changes in weight . Conclusion In this study of previously sedentary , overweight or obese , postmenopausal women we observed no difference in the actual and predicted weight loss with 4 and 8 KKW of exercise ( 72 and 136 minutes respectively ) , while the 12 KKW ( 194 minutes ) produced only about half of the predicted weight loss . However , all exercise groups had a significant reduction in waist circumference which was independent of changes in weight . Trial Registration Clinical Trials.gov NCT Keeping moderately active is the best way to boost total daily energy expenditure . BACKGROUND It is not clear how decreased activity quantitatively affects energy balance ( EB ) in subjects feeding ad libitum . OBJECTIVE We assessed the effect of an imposed sedentary routine on appetite , energy intake ( EI ) , EB , and nutrient balance in lean men for 7 d. DESIGN Six men with a mean ( + /-SD ) age of 23.0 + /- 2.3 y , weight of 69.2 + /- 11.4 kg , and height of 1.76 + /- 0.07 m were each studied twice during a sedentary [ 1.4 x resting metabolic rate ( RMR ) ] and a moderately active ( 1.8 x RMR ) regimen . During each treatment , they resided in the whole-body indirect calorimeter for the 7 d and had ad libitum access to OUTPUT: We found minimal evidence to support the hypothesis that prescribed physical activity/exercise training results in decreased non-exercise physical activity/energy expenditure in healthy adults . INPUT: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain INTRODUCTION The aims of this prospect i ve cohort study were to examine 16-year trajectories of weight and BMI in young adult women who had a healthy BMI in 1996 and determinants of remaining in the healthy BMI category . METHODS A total of 4,881 women with healthy BMI at baseline and either healthy , overweight , or obese BMI at 16-year follow-up reported their weight , height , health , and health behaviors in six surveys of the Australian Longitudinal Study on Women 's Health between 1996 ( aged 18 - 23 years ) and 2012 ( aged 34 - 39 years ) . Determinants of BMI maintenance were estimated using binary logistic regression and generalized estimating equations in 2015 . RESULTS Almost 60 % remained in the healthy BMI category from 1996 to 2012 , ( mean weight gain , 0.19 kg/year ) , 29 % transitioned to overweight BMI ( 0.83 kg/year ) , and 11.6 % transitioned to obese ( 1.73 kg/year ) . The mean rates of annual weight gain in each group were consistent over time . Only three factors ( low alcohol , moderate/high physical activity , having a university degree ) were positively associated with maintaining a healthy BMI . Additional behavioral factors ( smoking , high sitting time , energy intake , dieting , takeaway food , and use of oral contraceptives ) , as well as blue collar occupation , separation/divorce/widowhood , and major illness were negatively associated with BMI maintenance . CONCLUSIONS To prevent the transition from healthy to overweight/obese BMI , weight gain must be limited to < 0.5 kg/year . Women with healthy BMI , but with higher rates of weight gain in their early 20s , could be identified by health professionals for assistance with prevention of becoming overweight/obese Background / Objectives : Despite considerable research on the association between physical activity ( PA ) and body composition , there remains limited information on the directionality of the relationship . The present study examined the prospect i ve associations among objective ly measured PA , energy intake ( EI ) and body composition . Subjects/ Methods : A convenience sample of 430 adults ( 49 % male ) between 21 and 35 years of age was followed over 1 year with repeated measurements taken every 3 months . BMI ( kg/m2 ) and percent body fat ( % BF ) were calculated based on anthropometric measurements and dual energy X-ray absorptiometry . A multi-sensor device was worn over a period of 10 days to estimate total daily energy expenditure and time spent in different intensities . EI was calculated based on change in body composition and total daily energy expenditure . Results : A total of 379 participants provided valid data . On average , participants experienced a significant weight gain of 1.2±4.3 kg during the 12-month observation period , which was associated with an increase in % BF ( 0.8±3.2 % ) . Average time spent in moderate-to-vigorous PA ( MVPA ) decreased significantly , whereas EI remained constant . Optimal linear mixed models , adjusting for age and sex , showed an inverse effect of MVPA on BMI and % BF , whereas EI only directly affected BMI ( P<0.001 ) . There was also a significant inverse effect of BMI and % BF on MVPA ( P<0.001 ) . Conclusions : Results of this study indicate an inverse reciprocal association between MVPA and measures of adiposity . Thus , primary preventive actions are warranted to avoid excess weight gain , which may result in a vicious cycle of weight gain and low PA BACKG OUTPUT:

Conclusions Meta- analysis of data from prospect i ve cohort studies showed small , inconsistent and non-significant associations between sedentary behavior and body weight

MS2_dynamic_1_shot84

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: This clinical trial evaluated , over a 12-month period , the performance of brackets bonded to teeth etched and primed with Transbond Plus Self-Etching Primer ( SEP ) when compared with a conventional separate two-step etch and primer system . Thirty-nine r and omly selected patients requiring fixed appliance therapy were entered into the study . R and om allocation of each etching system , along with a ' split-mouth cross-quadrant ' design was used . A total of 661 brackets were placed by two operators . The failure and survival rates of the brackets were determined for age and gender of the patients , each etching system , operator , mode of failure , tooth position in the dental arch , and number of manipulations prior to curing the adhesive . Statistical analysis showed that SEP had a significantly higher bond failure rate ( 11.2 per cent ) than the conventional etch and primer system ( 3.9 per cent ) at the P = 0.001 level . Cox 's proportional hazards regression showed the conventional etch and primer system to have a 60 per cent reduced chance of bracket failure over a 12-month observation period , while males had a 2.4 times increased risk compared with females . The predominant mode of failure was at the composite enamel interface for the SEP , while for the conventional etch and primer system , it was within the composite adhesive . No statistically significant differences were found for the failure rate with respect to the age of the patient , operator , tooth location , or the number of manipulations of the bracket . This in vivo study showed that brackets bonded using SEP had an increased clinical bond failure rate compared with the conventional , separate , etch and prime system The split-mouth design is a popular design in oral health research . In the most common split-mouth study , each of two treatments are r and omly assigned to either the right or left halves of the dentition . The attractiveness of the design is that it removes a lot of inter-individual variability from the estimates of the treatment effect . However , already about 20 years ago the pitfalls of the design have been reported in the oral health literature . Yet , many clinicians are not aware of the potential problems with the split-mouth design . Further , it is our experience that most statisticians are not even aware of the existence of this design . Since most of the critical remarks appeared in the oral health literature , we argue that it is necessary to introduce the split-mouth design to a statistical audience , so that both clinicians and statisticians clearly underst and the advantages , limitations , statistical considerations , and implication s of its use in clinical trials and advise them on its use in practice Glass ionomer orthodontic adhesives cause less enamel demineralization during fixed orthodontic appliance treatment than do traditional resin-based products . An in vivo r and omized clinical trial was performed comparing the clinical performance of a resin-modified glass ionomer ( RMGI ) adhesive with a no-mix , resin-based ( the control ) adhesive over a 12-month period . The split-mouth technique was used to analyze bracket retention , bracket failure causes , and mode of failure for both adhesives in 61 patients . Bracket-failure rates were 10 % for the RMGI and 4 % for the resin-based adhesive . Both adhesives had 4 times more bracket failures when opposing occlusion was present . The resin-based product demonstrated a higher proportion of resin-to-enamel adhesive failures than did the RMGI . Compared with the resin-based adhesive , the RMGI-bracketed teeth showed improved clinical performance , no enamel surface loss , less enamel demineralization , and faster adhesive removal . However , the RMGI had a 2.6 times greater bracket-failure rate than did the resin-based product The aim of this study was to evaluate , over an 18-month period , the clinical performance of a self-etch adhesive [ Transbond Plus Self Etching Primer ( SEP ) , 3 M Unitek ] compared with a conventional adhesive that employs the etch- and -rinse approach ( Transbond XT , 3 M Unitek ) . One operator , using the straight-wire technique , bonded 567 metallic brackets to the teeth of 30 patients ( age range 12 - 18 years ) in a way that patients acted as self-control . The brackets were bonded following the manufacturers ' instructions except for the fact that the self-etch system was brushed for a longer time than recommended ( 10 - 15 seconds ) since previous investigations have reported that prolonged application times can improve the bonding efficacy of self-etch systems to enamel . The failure modes were visually classified into : adhesive-enamel , adhesive-bracket , and cohesive failure . The survival rates of the brackets were estimated by Kaplan-Meier and log-rank test ( P < 0.05 ) . The failure rates of the self-etch and conventional adhesives were 15.6 and 17.6 per cent , respectively . No significant differences in the survival rate were observed between the material s ( P > 0.05 ) . Most of the failures were cohesive and at the adhesive-enamel interface . There was no difference in the fracture debonding mode . These findings indicate that Transbond Plus SEP can be safely used for orthodontic brackets since the survival rates are similar to the conventional Transbond XT The aim of this study was to compare the clinical performance of a self-etching primer ( SEP ) with a conventional two-step etch and primer [ conventional method ( CM ) ] . The chair time required for bonding was also evaluated . Thirty-seven patients ( 14 males and 23 females ) with a mean age of 16 years 5 months were included in the study . Six hundred and seventy-two brackets were bonded by one operator using a split-mouth design , with either SEP ( Transbond Plus ) or CM ( Transbond XT ) . Bracket failure rates were estimated with respect to bonding procedure , dental arch , type of tooth ( incisor , canine , and premolar ) , and gender . The results were evaluated using the chi-square test . The survival rate of the brackets OUTPUT: We found low- quality evidence that was insufficient to conclude whether or not there is a difference in bond failure rate between SEPs and conventional etching systems when bonding fixed orthodontic appliances over a 5- to 37-month follow-up . INPUT: Objective To evaluate the shear bond strength of precoated orthodontic brackets bonded with self-etching primer relative to that of noncoated conventionally-bonded brackets at two different time intervals . Methods Twenty-one subjects were selected for r and omized split-mouth bonding of two types of brackets to the maxillary arch . Half of the teeth had precoated brackets bonded using self-etching adhesive , and the other half had regular brackets bonded using Transbond XT adhesive . Nitinol wires were tied to the upper arch and were left until the time of debonding . The patients were r and omly divided into two groups : one debonded after one hour and the other debonded two weeks after the initial wire placement . The shear bond strength was directly recorded from the patients ’ mouths using an in vivo debonding device . Results There were no significant differences in shear bond strength between the precoated and conventional groups or within each group at different time intervals . There were significant differences between anterior and posterior teeth in both the precoated and conventional groups . Conclusion Pre-coated brackets bonded with self-etching adhesive have the same bonding strength as the conventionally bonded brackets The purpose of the present study was to test a new in vivo debonding device and compare in vivo bond strengths recorded by this device with in vitro bond strengths recorded by a universal testing machine such as the Instron . For the in vitro part of the study , 60 extracted premolar teeth were divided into 2 groups of 30 each . Both groups of 30 teeth had 3 M Unitek Victory Twin brackets , precoated with Transbond XT composite resin , bonded to them . Shear bond strength tests were carried out in vitro using the universal testing machine on one group of 30 teeth while the debonding device was used on the other group of 30 teeth . The mean shear bond strength of the group debonded using the universal machine was 11.02 MPa and that of the group debonded with the debonding device was 12.82 MPa . For the in vivo part of the study , 8 patients r and omly assigned to the research clinician from patients in The University of Alabama School of Dentistry , Department of Orthodontics , had a total of 60 premolar teeth bonded with 3 M Unitek Victory Twin brackets . Following comprehensive orthodontic treatment ( average time of 23 months ) , shear bond strength tests were carried out using the debonding device , which can measure debonding forces in vivo . The mean shear bond strength recorded in vivo was 5.47 MPa . Statistically significant differences were found between all 3 groups tested . The results appear to indicate that mean bond strengths recorded in vivo following comprehensive orthodontic treatment are significantly lower than bond strengths recorded in vitro The aim of this study was to evaluate the influence of a self-etching primer ( SEP ) ( Transbond Plus SEP , 3 M Unitek , Monrovia , Calif ) on shear bond strength of adhesive uncoated and precoated Victory brackets ( 3 M Unitek ) . The sample group consisted of 23 patients , with four premolars each , equally divided in four different groups . Brackets were bonded in vivo by the same operator using a split-mouth r and om technique : group 1 , 37 % phosphoric acid + primer + composite + conventional Victory bracket ; group 2 , 37 % phosphoric acid + primer + precoated Victory bracket ; group 3 , SEP + composite + conventional bracket ; group 4 , SEP + precoated bracket . After 30 days , premolars were extracted for orthodontic reasons and a Universal Instron Machine was used to apply an occlusal shear force directly to the enamel-bracket interface at a speed of 0.5 mm/min . The groups were compared using two-way analysis of variance . Mean results and st and ard deviation for the groups were : group 1 = 11.60 + /- 2.65 Mpa , group 2 = 9.79 + /- 2.71 Mpa , group 3 = 10.75 + /- 2.67 Mpa , and group 4 = 10.31+/- 2.70 Mpa . No difference was observed between the conventional etching and primer or SEP ( P = .948 ) . However , significant differences in bond strength were present between the uncoated and precoated brackets ( P = .032 ) . Considering the values required to withst and normal orthodontic forces ( 8 - 9 Mpa ) , it could be concluded that the SEP combined with adhesive precoated brackets showed adequate shear bond strength and may be suitable for clinical use OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established OUTPUT:

The review reached no real conclusion apart from the lack of efforts to clinical ly evaluate the bonding efficiency of a wide range of orthodontic bracket-adhesive systems in terms of debonding force compared to laboratory-based in vitro and ex vivo studies

MS2_dynamic_1_shot85

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: We studied premature atherosclerosis with carotid Doppler ultrasonography in active acromegaly before and after treatment . Patients ( n = 27 ) with active acromegaly and 12 age- , gender- , and body mass index-matched healthy individuals were included in the study . Carotid intima – media thickness was decreased significantly in the inactive group after treatment ( median : 0.6 mm , interquartile range [ IQR ] : 0.55 - 0.80 ] ) when compared with the active group ( median : 0.9 mm [ IQR : 0.75 - 1.15 ] , P < .0001 ) , but there was no significant difference between the inactive and control groups . There was a correlation between homeostasis model of assessment –insulin resistance ( P = .01 , r = .41 ) and growth hormone ( GH ; P < .0001 , r = .46 ) . In conclusion , premature atherosclerosis was demonstrated in active acromegaly patients probably as a consequence of insulin resistance and direct vascular effects of GH and /or insulin-like growth factor 1 BACKGROUND Acromegaly is known to be associated to vascular damage characterized by an increase of vascular wall thickness and an impairment of vascular function . AIM The aim of this study was to evaluate the effect of medical treatment with the GH receptor antagonist pegvisomant on vascular structure and function in acromegalic patients resistant to somatostatin analogues . PATIENTS Ten patients ( 4 males and 6 females , 28 - 58 yr ) and 20 sex- , age- , and body mass index-matched healthy controls entered the study . All patients were treated for 18 months with pegvisomant at doses ranging from 10 to 40 mg/day . OUTCOME MEASURES Primary outcome measures were measurement of carotid arteries intima-media thickness ( IMT ) , and brachial arteries flow mediated dilation ( FMD ) ; secondary outcome measures were blood pressure , blood glucose and lipids levels . RESULTS Carotid arteries maximal IMT was significantly higher in patients than in controls at baseline ( 1.18±0.59 vs 0.69±0.13 , p=0.001 ) and slightly , but not significantly , decreased after treatment ( 0.97±0.17 ) . Brachial arteries FMD was significantly lower in patients than controls at baseline ( 7.5±2.5 vs 13.1±1.4 , p<0.001 ) and significantly increased after treatment ( 8.8±3.7 , p=0.016 ) . Systolic ( SBP ) and diastolic ( DBP ) blood pressure values , serum glucose and insulin levels and homeostasis model assessment ( HOMA ) index were higher , whereas HDL-cholesterol levels were lower in patients than controls at baseline . After treatment , SBP and DBP , as well as serum glucose and insulin levels and HOMA index significantly decreased whereas no significant change was found in serum lipid profile . CONCLUSIONS The results of the current study suggested that long-term treatment with pegvisomant induced a slight reduction of carotid arteries wall thickness and a significant improvement of brachial arteries vascular function in patients with acromegaly resistant to somatostatin analogues UNLABELLED Vascular changes are common in acromegaly ( ACM ) . Current therapies can normalise the levels of both growth hormone ( GH ) and insulin-like growth factor ( IGF1 ) . OBJECTIVE To establish whether the ACM vascular changes in patients with effectively managed disease are different from those in patients with an active condition . METHODS 64 ACM patients were tested for serum GH ( r and om and during an oral glucose tolerance test ) and IGF1 . Ultrasonography of the right common carotid ( RCC ) explored structural ( the carotid diameter and intima-media thickness index ( IMT ) ) and functional ( the augmentation index ( AIx ) , elastic modulus ( Ep ) , and local pulse wave velocity ( PWV ) ) arterial parameters in the ACM patients ( groups A and B ) and an age- and sex-matched control group of 21 patients without acromegaly ( group C ) . RESULTS The ACM patients were divided into 2 subgroups that had similar cardiovascular risk factor profiles : A ( n=10 , with controlled ACM ) , and B ( n=54 , with active ACM ) . The AIx was higher in groups A ( 27.7 % [ 2.2 - 54.3 ] ) and B ( 20.0 % [ - 38.2 - 97.1 ] ) than in group C ( 3.5 % [ - 11.3 - 31.1 ] ) , p=0.01 and 0.002 , respectively . The group B patients presented with poorer functional carotid wall parameters than the control subjects : Ep-95.5 [ 33 - 280 ] KPa vs. 77.5 [ 39 - 146 ] KPa , p=0.01 ; and PWV-6 [ 3.6 - 10.4 ] m/s vs. 5.4 [ 3.9 - 7.2 ] m/s , p=0.03.The ACM patients had greater RCC diameters ( 6.4 ± 0.6 mm vs. 5.7 ± 0.6 mm , p<0.001 ) and IMT values ( 0.72 ± 0.13 mm vs. 0.58 ± 0.08 mm , p<0.001 ) than the subjects in group C. CONCLUSIONS Both the controlled and active ACM patients showed structural arterial changes . After 1 year of disease control , the patients with controlled ACM showed improvements in the functional , but not the structural , OUTPUT: Conclusions IMT , FMD and arterial stiffness are impaired in acromegaly showing that these patients may be at increased risk of atherosclerosis . In patients with active disease these pre clinical markers of atherosclerosis are worse compared to patients with inactive disease but the role of diabetes and hypertension is prevailing on growth hormone excess INPUT: 1 . In adult humans with growth hormone deficiency , treatment with growth hormone has recently been shown to have major anabolic effects and to improve exercise performance . The cardiovascular effects of growth hormone in adults with growth hormone deficiency were examined in 24 patients treated with recombinant human growth hormone ( 0.07 units/kg at night ) in a double-blind , placebo-controlled trial lasting 6 months . 2 . Compared with placebo , resting M-mode echocardiography showed increases in left ventricular end-diastolic dimension and stroke volume in the group treated with recombinant human growth hormone . No differences were noted between the groups with respect to left ventricular end-systolic dimension , fractional shortening , wall thicknesses or mean arterial blood pressure . Left ventricular myocardial mass increased in the group given recombinant human growth hormone . 3 . The supine plasma renin activity was increased and remained elevated over the 6 months , whereas the plasma aldosterone concentration was unchanged , after treatment with recombinant human growth hormone . Clinical signs of sodium retention were evident during the first 3 months of treatment with recombinant human growth hormone . 4 . We conclude that treatment with recombinant human growth hormone in adults with growth hormone deficiency result ed in small increases in left ventricular pre-load , due to the sodium-retaining action of growth hormone . Activation of the renin-aldosterone system was involved in such changes . Myocardial hypertrophy was observed without changes in mean arterial pressure , reflecting the anabolic action of growth hormone OBJECTIVES The goal of this study was to determine the predictive value of pregnancy-associated plasma protein-A ( PAPP-A ) in patients with acute coronary syndromes ( ACS ) . BACKGROUND Pregnancy-associated plasma protein-A is a zinc-binding matrix metalloproteinase abundantly expressed in eroded and ruptured plaques and may serve as a marker of plaque destabilization . METHODS In 547 patients with angiographically vali date d ACS and in a heterogeneous emergency room population of 644 patients with acute chest pain , respectively , PAPP-A as well as markers of myocardial necrosis ( troponin T [ TnT ] ) , ischemia ( vascular endothelial growth factor [ VEGF ] ) , inflammation ( high-sensitivity C-reactive protein [ hsCRP ] ) , anti-inflammatory activity ( interleukin [IL]-10 ) , and platelet activation ( soluble CD40 lig and [ sCD40L ] ) were determined . Patients were followed for the occurrence of death or myocardial infa rct ion . RESULTS In patients with ACS , elevated PAPP-A levels ( > 12.6 mIU/l ) indicated an increased risk ( odds ratio 2.44 [ 95 % confidence interval ( CI ) 1.43 to 4.15 ] ; p = 0.001 ) . When the analysis was restricted to TnT-negative patients , PAPP-A still identified a subgroup of high-risk patients ( odds ratio [ OR ] 2.72 [ 95 % confidence interval ( CI ) 1.25 to 5.89 ] ; p = 0.009 ) . In a multivariable model , PAPP-A ( OR 2.01 ; p = 0.015 ) , sCD40L ( OR 2.37 ; p = 0.003 ) , IL-10 ( OR 0.43 ; p = 0.003 ) , and VEGF ( OR 2.19 ; p = 0.018 ) were independent predictors . Prospect i ve validation in patients with chest pain confirmed that PAPP-A levels reliably identify high-risk patients ( adjusted OR 2.32 [ 95 % CI 1.32 to 4.26 ] ; p = 0.008 ) . Patients negative for all three markers ( TnT , sCD40L , and PAPP-A ) were at very low cardiac risk ( 30 days : 3.0 % event rate ; no death ) . CONCLUSIONS The PAPP-A level as a marker of plaque instability is a strong independent predictor of cardiovascular events in patients with ACS . Simultaneous determination of biomarkers with distinct pathophysiological profiles appears to remarkably improve risk stratification in patients with ACS CONTEXT Data regarding effects of lower-dose GH on cardiopulmonary function in GH-deficient ( GHD ) adults are limited . OBJECTIVES The objective was to assess effects of lower-dose GH on exercise capacity and echocardiographic parameters in GHD adults . DESIGN The study was a 6-month double-blind , placebo-controlled r and omized trial . SETTING The study was conducted at the General Clinical Research Center . PARTICIPANTS Thirty hypopituitary adults with GHD were studied . INTERVENTION Subjects were r and omized to recombinant human GH or placebo for 6 months , followed by open-label recombinant human GH for 12 months . MAIN OUTCOME MEASURES Primary endpoints were exercise duration , maximal oxygen consumption , and left ventricular ejection fraction . Secondary endpoints were echocardiographic indices of systolic and diastolic function , left ventricular mass , lipids , and body composition . RESULTS In the 6-month double-blind phase , mean GH dose was 0.64 mg/d . Mean IGF-I sd score increased from -4.5 to -1.0 . Exercise duration , maximal oxygen consumption , left ventricular ejection fraction , and other echocardiographic parameters were normal at baseline and did not change . GH decreased total and low-density lipoprotein cholesterol by 7.5 % ( P = 0.016 ) and 14.7 % ( OUTPUT:

Emerging cardiovascular risk factors/markers such as proinflammatory cytokines , C-reactive protein , and adipokines are also increased in GHD patients . Increased cardiovascular morbidity and mortality have also been reported in GHD . GH treatment has been shown to improve both traditional and emerging cardiovascular risk factors and markers . The GHD population may be considered at high cardiovascular risk , and GH substitution may be expected to bring an added value to patients with hypopituitarism in terms of cardiovascular protection .

MS2_dynamic_1_shot86

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objective : To evaluate the contribution to peak bone mass of exercise , smoking , and calcium intake in adolescents and young adults . Design : Prospect i ve cohort study with end point measurement ( bone mineral density ) after 11 years'20follow up for lifestyle . Setting : Five university hospital clinics . Subjects : 264 ( 153 females , 111 males ) subjects aged 9 to 18 years at the beginning of the follow up20 and 20 to 29 years at the time of measurement of bone mineral density . Main outcome measure : Bone mineral density of lumbar spine and femoral neck by dual energy x ray absorptiometry ; measures of physical activity and 20smoking and estimates of calcium intake repeated three times during follow up . Results : In the groups with the lowest and highest20levels of exercise the femoral bone mineral densities ( adjusted for age and weight ) were 0.918 and 0.988 g/cm2 for women ( P=0.015 ) , analysis of covariance ) and 0.943 and 1.042 g/cm2 for men ( P=0.005 ) , respectively ; at the lumbar spine the respective20values were 1.045 and 1.131 ( P=0.005 ) for men . In men the femoral bone mineral densities ( adjusted for age , weight , and exercise ) were 1.022 and 0.923 g/cm2 for the groups with the lowest and highest values of smoking index ( P=0.054 , analysis of covariance ) . In women the adjusted femoral bone mineral density increased by 4.7 % together with increasing calcium intake ( P=0.089 , analysis of covariance ) . In multiple regression analysis on bone mineral density of the femoral neck , weight , exercise , age , and smoking were independent predictors for men ; with weight , exercise , and age for women . These predictors together explained 38 % of the variance in bone mineral density in women and 46 % in men . At the lumbar spine , weight , smoking , and exercise were predictors for men ; and only weight for women . Conclusions : Regular exercise and not smoking is important in achieving maximal peak bone mass in adolescents and young adults Adequate nutrition is needed for the accrual of bone mass during the pre- and postpubertal growth periods . This study aim ed to examine the associations between dietary calcium , vitamin D ( calciferol ) , and milk intakes and 25-hydroxyvitamin D [ 25(OH)D ] status and bone mineral content ( BMC ) and bone mineral density ( BMD ) in Spanish adolescents , aged 12.5 - 17.5 years , participating in the Healthy Lifestyle in Europe by Nutrition in Adolescence Cross-Sectional Study ( HELENA-CSS ) . Bone mass was measured with dual-energy X-ray absorptiometry and diet via 2 nonconsecutive 24-h dietary recalls ( n=227 ; 48 % males ) . A r and om sub sample of 101 adolescents ( 46 % males ) had available measures of 25(OH)D. Multiple linear regression was applied . Significant adjusted associations were observed in males , among milk intakes and BMC and BMD . Also in males , whole-body , head , and right arm BMD were positively related to calcium intakes . In females , 25(OH)D was positively related among others to whole-body , subtotal , and left and right arm BMC and BMD . It could be speculated that diet is not a limiting factor of bone mass development in this group of healthy adolescents , and further research on the effect of other factors in addition to diet in a larger sample should be undertaken CONTEXT It is widely believed that fractures result ing from high trauma are not osteoporotic ; however , this assumption has not been studied prospect ively . OBJECTIVE To examine the association between bone mineral density ( BMD ) and high-trauma fracture and between high-trauma fracture and subsequent fracture in older women and men . DESIGN , SETTING , AND PARTICIPANTS Two prospect i ve US cohort studies in community-dwelling adults 65 years or older from geographically diverse sites . The Study of Osteoporotic Fractures followed up 8022 women for 9.1 years ( 1988 - 2006 ) . The Osteoporotic Fractures in Men Study followed up 5995 men for 5.1 years ( 2000 - 2007 ) . MAIN OUTCOME MEASURES Hip and spine BMD were assessed by dual-energy x-ray absorptiometry . Incident nonspine fractures were confirmed by radiographic report . Fractures were classified , without knowledge of BMD , as high trauma ( due to motor vehicle crashes and falls from greater than st and ing height ) or as low trauma ( due to falls from st and ing height and less severe trauma ) . RESULTS Overall , 264 women and 94 men sustained an initial high-trauma fracture and 3211 women and 346 men sustained an initial low-trauma fracture . For women , each 1-SD reduction in total hip BMD was similarly associated with an increased risk of high-trauma fracture ( multivariate relative hazard [ RH ] , 1.45 ; 95 % confidence interval [ CI ] , 1.23 - 1.72 ) and low-trauma fracture ( RH , 1.49 ; 95 % CI , 1.42 - 1.57 ) . Results were consistent in men ( high-trauma fracture OUTPUT: Young adult swimmers present similar BMD values than CG and lower values than HIGH INPUT: Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The bone mineral content ( B.M.C. ) in both forearms ( related to total body calcium ) was measured by photon absorptiometry for a controlled therapeutic trial in a representative sample of epileptic out patients , comprising 226 patients treated with one or two major anticonvulsant drugs ( phenytoin , phenobarbitone , primidone ) . Initially the mean B.M.C. value for all epileptic patients was 87 % of normal . During treatment with 2,000 international units of vitamin D2 daily for three months an average B.M.C. increase of 4 % was found , whereas the B.M.C. values remained unchanged in the placebo group and in the control groups . The incidence of hypocalcaemia and raised serum alkaline phosphatase was 12 % and 43 % respectively . The biochemical indices of osteomalacia were related to B.M.C. These results indicate that epileptic patients should be closely supervised for the occurrence of anticonvulsant osteomalacia , and , possibly , receive prophylactic treatment with vitamin BACKGROUND Care of elderly patients after hip fracture is not well established . METHODS We enrolled 173 patients with acute hip fracture who were 65 years or older ( 79.2 % women ; mean age , 84 years ; 77.4 % living at home ) . Using a factorial design , we r and omly allocated patients to extended physiotherapy ( PT ) ( supervised 60 min/d during acute care plus an unsupervised home program ) vs st and ard PT ( supervised 30 min/d during acute care plus no home program ; single-blinded ) , and to cholecalciferol therapy , 2000 vs 800 IU/d ( double-blinded ) . Primary outcome was rate of falls ; secondary outcome was rate of hospital readmissions during the 12-month follow-up . All analyses included 173 individuals and used multivariate Poisson regression analyses . RESULTS At baseline , 50.9 % of participants had 25-hydroxyvitamin D levels of less than 12 ng/mL and 97.7 % of less than 30 ng/mL. We documented 212 falls and 74 hospital readmissions . Because this was a factorial design trial , all analyses tested the main effect of each treatment while controlling for the other in 173 participants . Extended vs st and ard PT reduced the rate of falls by 25 % ( 95 % confidence interval [ CI ] , -44 % to -1 % ) . Cholecalciferol treatment , 2000 vs 800 IU/d , did not reduce falls ( 28 % ; 95 % CI , -4 % to 68 % ) , but reduced the rate of hospital readmissions by 39 % ( 95 % CI , -62 % to -1 % ) . CONCLUSIONS Extended PT was successful in reducing falls but not hospital readmissions , whereas cholecalciferol treatment , 2000 IU/d , was successful in reducing hospital readmission but not falls . Thus , the 2 strategies may be useful together because they address 2 different and important complications after hip fracture BACKGROUND The objective of the study was to evaluate bone mass status ( as measured by bone ultrasound ) in patients on anticonvulsant therapy , and the influence that Vitamin D administration exerts over it . MATERIAL S AND METHODS We measured and compared the basal serum levels of 25(OH)D3 , parathyroid hormone ( PTH ) , and phalangeal bone ultrasound ( Ad-SOS ) , in 30 adult patients who were taking anticonvulsant drugs , with a control group of similar age and sex . We then gave the patients a large oral dose of 3 mg ( 120.000 UI ) of 25(OH)D3 , and repeated the measurements after one month . RESULTS Basal 25(OH)D3 and Ad-SOS values were significantly lower , and PTH values significantly higher ( P < 0.0001 in all ) , in the patient group . The low Ad-SOS values for the patients were independent of the treatment , but directly related to basal 25(OH)D3 levels ( r = 0.45 , P<0.01 ) . There was a negative association between PTH and 25(OH)D3 ( r = -0.64 , P<0.0001 ) , and no correlation between PTH y Ad-SOS ( r = -0.20 , p NS ) . After ingestion of the large dose of the vitamin D , the patient group registered a significant ( P<0.0001 ) increase in 25(OH)D3 levels , their Ad-SOS values increased ( P<0.0001 ) nearly to the mean basal value of the control group , and PTH decreased significantly ( P<0.0001 ) . CONCLUSIONS These findings justify the need to assure adequate vitamin D intake in patients being treated with anticonvulsants , independently of the treatment , age , sex , and activity status , in order to prevent osteomalacia PURPOSE To evaluate whether use of a bisphosphonate ( risedronate ) in addition to calcium and vitamin D in male veterans with epilepsy who were taking antiepileptic drugs ( AEDs ) long term can prevent the loss of bone mass ( BMD , bone mineral density ) associated with AED use compared to patients who were treated with a placebo plus calcium and vitamin D. As a secondary end point we studied the incidence of new morphometric vertebral and nonvertebral fractures . METHODS Antiepileptic drug and osteoporosis prevention trial OUTPUT:

All 6 studies that investigated bone mineralization had significant findings ; however , due to varying method ologies , the impact of vitamin D on bone mineralization was inconclusive . SIGNIFICANCE Vitamin D does appear to have some benefit to bone health in adults with epilepsy , and therefore supplementation could potentially be a requisite to using some AEDs .

MS2_dynamic_1_shot87

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain 512 Background : Obesity is an adverse prognostic factor in early BC . We conducted a r and omized clinical trial ( RCT ) to evaluate a 2-year , central ly delivered , telephone-based weight loss intervention ( WLI ) compared to a mailed educational intervention ( EI ) on recurrence , weight loss and QOL in postmenopausal women receiving adjuvant Letrozole . The trial was terminated after 338 of a planned 2,150 women were enrolled due to loss of funding . METHODS 338 women with stage I-IIIa BC were r and omized to WLI ( n%171 ) or EI alone ( n%167 ) at 20 centers in Canada and USA . Eligibility included BMI ≥24 kg/m2 and <3 years of definitive surgery . WLI involved 19 calls , mailings and a participant manual . Weight loss goal was 10 % of baseline via reduction of caloric and fat intake ( 500 - 1000 kcal/day , 20 % calories fat ) and increased physical activity ( 150 - 200 minutes/week ) . RESULTS Mean age and BMI were 61 years and 31.3 kg/m2 . Baseline BMI , adjuvant chemotherapy , and tumor characteristics were balanced between arms . 87.5 % of protocol m and ated WLI calls took place . Mean weight change is shown in the table . Results were similar for baseline BMI ≥/<30 kg/m2 and adjuvant chemotherapy ( yes/no ) . Mean SF 36 normalized physical component score was improved in WLI vs. EI at 6 ( + 4.1 WLI vs. + 2.1 C , p%0.046 ) and 12 months ( + 3.9 WLI vs. + 2.7 EI , p%0.33 ) . CONCLUSIONS A 2-year , telephone-based WLI result ed in significant weight loss at 6 , 12 , and 18 months in early BC . Results were similar with BMI < 30 or 30 + and with or without adjuvant chemotherapy . Follow-up continues to evaluate longer term effects . Funded by Novartis Pharmaceuticals Inc. Sponsored by the Ontario Clinical Oncology Group . [ Table : see text ] A continuing challenge in weight loss treatment is attaining maintenance of weight loss . The goal of this study was to develop a counseling method that would assist African American breast cancer survivors with weight loss maintenance . In this pilot study , 31 obese breast cancer survivors were recruited . Individualized , dietitian-led counseling by telephone and free Weight Watchers coupons were provided to all participants for 18 months . At the 6-month time point , women were r and omized to receive spirituality counseling or not in addition to the st and ard program . The spirituality counseling was delivered via telephone using an 8-step framework . Subjects were asked to utilize daily meditation or prayer , daily readings , and the recording of thoughts in a journal . Mean weight loss from baseline to 6 months was a modest 2.0 % of baseline weight . From 6 to 18 months , there was no further weight change in the spirituality arm and a gain of 0.7 % in the dietitian-only arm . Despite little effect on weight loss , it did appear that spirituality counseling positively affected spiritual well-being ( FACIT-Sp ) scores and dietary quality . The spirituality counseling framework therefore may be further refined and useful for other health promotion studies with African American population Excess body weight at diagnosis and weight gain after breast cancer are associated OUTPUT: The studies included in this review suggest that weight loss is feasible to achieve and is safe in women following treatment for breast cancer . INPUT: Overweight and obesity affects more than 66 % of the adult population and is associated with a variety of chronic diseases . Weight reduction reduces health risks associated with chronic diseases and is therefore encouraged by major health agencies . Guidelines of the National Heart , Lung , and Blood Institute ( NHLBI ) encourage a 10 % reduction in weight , although considerable literature indicates reduction in health risk with 3 % to 5 % reduction in weight . Physical activity ( PA ) is recommended as a component of weight management for prevention of weight gain , for weight loss , and for prevention of weight regain after weight loss . In 2001 , the American College of Sports Medicine ( ACSM ) published a Position St and that recommended a minimum of 150 min wk(-1 ) of moderate-intensity PA for overweight and obese adults to improve health ; however , 200 - 300 min wk(-1 ) was recommended for long-term weight loss . More recent evidence has supported this recommendation and has indicated more PA may be necessary to prevent weight regain after weight loss . To this end , we have reexamined the evidence from 1999 to determine whether there is a level at which PA is effective for prevention of weight gain , for weight loss , and prevention of weight regain . Evidence supports moderate-intensity PA between 150 and 250 min wk(-1 ) to be effective to prevent weight gain . Moderate-intensity PA between 150 and 250 min wk(-1 ) will provide only modest weight loss . Greater amounts of PA ( > 250 min wk(-1 ) ) have been associated with clinical ly significant weight loss . Moderate-intensity PA between 150 and 250 min wk(-1 ) will improve weight loss in studies that use moderate diet restriction but not severe diet restriction . Cross-sectional and prospect i ve studies indicate that after weight loss , weight maintenance is improved with PA > 250 min wk(-1 ) . However , no evidence from well- design ed r and omized controlled trials exists to judge the effectiveness of PA for prevention of weight regain after weight loss . Resistance training does not enhance weight loss but may increase fat-free mass and increase loss of fat mass and is associated with reductions in health risk . Existing evidence indicates that endurance PA or resistance training without weight loss improves health risk . There is inadequate evidence to determine whether PA prevents or attenuates detrimental changes in chronic disease risk during weight gain BACKGROUND The proportion of overweight adolescents has increased , but the behavioral risk factors for overweight youth are not well understood . OBJECTIVE To examine how diet , physical activity , and sedentary behaviors relate to overweight status in adolescents . DESIGN AND SETTING Baseline data from the Patient-Centered Assessment and Counseling for Exercise Plus Nutrition Project , a r and omized controlled trial of adolescents to determine the effects of a clinic-based intervention on physical activity and dietary behaviors . PARTICIPANTS A total of 878 adolescents aged 11 to 15 years , 42 % of whom were from minority background s. MAIN OUTCOME MEASURE Centers for Disease Control and Prevention body mass index-for-age percentiles divided into 2 categories : normal weight ( < 85th percentile ) and at risk for overweight plus overweight ( AR + O ) ( > or=85th percentile ) . RESULTS Overall , 45.7 % of the sample was classified as AR + O with a body mass index for age at the 85th percentile or higher . More girls from minority background s ( 54.8 % ) were AR + O compared with non-Hispanic white girls ( 42 % ) ( chi(2)(1 ) = 7.6 ; P = .006 ) . Bivariate analyses indicated that girls and boys in the AR + O group did fewer minutes per day of vigorous physical activity , consumed fewer total kilojoules per day , and had fewer total grams of fiber per day than those in the normal-weight group . Boys in the AR + O group also did fewer minutes per day of moderate physical activity and watched more minutes per day of television on nonschool days than normal-weight boys . Final multivariate models indicated that independent of socioeconomic status ( as assessed by household education level ) , girls had a greater risk of being AR + O if they were Hispanic or from another minority background ( odds ratio [ OR ] = 1.65 ; 95 % confidence interval [ CI ] , 1.09 - 2.49 ) and a reduced risk of being AR + O as minutes per day of vigorous physical activity increased ( OR = 0.93 ; 95 % CI , 0.89 - 0.97 ) . A low level of vigorous physical activity was the only significant risk factor for boys being AR + O ( OR = 0.92 ; 95 % CI , 0.89 - 0.95 ) . Analyses based on meeting behavioral guidelines supported these findings and showed that failing to meet the 60 min/d moderate to vigorous physical activity guideline was associated with overweight status for both girls and boys . In addition , boys who failed to meet sedentary behavior and dietary fiber guidelines were more likely to be overweight . CONCLUSIONS Of the 7 dietary and physical activity variables examined in this cross-sectional study , insufficient vigorous physical activity was the only risk factor for higher body mass index for adolescent boys and girls . Prospect i ve studies are needed to clarify the relative importance of dietary and physical activity behaviors on overweight in adolescence BACKGROUND It is unclear how moderate and vigorous intensities of physical activity ( PA ) are associated with cardiovascular fitness ( CVF ) and percentage of body fat ( % BF ) in adolescents . OBJECTIVE We tested the hypothesis that vigorous PA , to a greater degree than moderate PA , would be associated with better CVF and lower % BF . DESIGN This was a cross-sectional study of 421 black and white high school students ( x age : 16 y ) . PA was measured with 5 d of accelerometry and expressed OUTPUT:

Question naires were the more predominant way to evaluate PA . Most studies showed that PA promotes a protective effect against a higher BF gain . CONCLUSION It was concluded that PA has a protective effect against BF with differences between the genders and according to the BF marker or measurement assessed ; higher intensity PA leads to a greater effect against BF gain in both genders ; and the maintenance or increase of PA level on BF observed through analysis of change in PA level yielded more consistent findings in the relation between PA and BF

MS2_dynamic_1_shot88

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: AIMS Hydrotherapy , i.e. exercise in warm water , as a rehabilitation program has been considered potentially dangerous in patients with chronic heart failure ( CHF ) due to the increased venous return caused by the hydrostatic pressure . However , hydrotherapy has advantages compared to conventional training . We studied the applicability of an exercise programme in a temperature-controlled swimming pool , with specific reference to exercise capacity , muscle function , quality of life and safety . METHODS AND RESULTS Twenty-five patients with CHF ( NYHA II-III , age 72.1+/-6.1 ) were r and omised into either 8 weeks of hydrotherapy ( n=15 ) , or into a control group ( n=10 ) . The training program was well tolerated with no adverse events . Patients in the hydrotherapy group improved their maximal exercise capacity ( + 6.5 vs.-5.9 W , P=0.001 ) , isometric endurance in knee extension ( + 4 vs.-9 s , P=0.01 ) together with an improvement in the performance of heel-lift ( + 4 vs. -3 n.o . , P=<0.01 ) , shoulder abduction ( + 12 vs. -8 s , P=0.01 ) and shoulder flexion ( + 6 vs. + 4 , P=0.01 ) in comparison to patients in the control group . CONCLUSION Physical training in warm water was well tolerated and seems to improve exercise capacity as well as muscle function in small muscle groups in patients with CHF . This new approach broadens the variety of training regimes for older patients with CHF BACKGROUND Peak oxygen uptake ( pVO2 ) is used for risk stratification in chronic heart failure ( CHF ) , but little is known about the prognostic impact of pVO2-changes in patients on chronic beta-blocker ( BBL ) therapy . We therefore prospect ively evaluated individual pVO2-changes at a 6-month interval in patients all receiving BBL . METHODS 194 patients with stable CHF on stable medication were included ( V1 ) and underwent clinical evaluation and exercise testing . Testing was repeated ( V2 ) at 5.7+/-1.5 months after V1 and patients were followed > 12 months after V2 . Death or hospitalisation due to cardiac reasons was the predefined EP ( EPP , end-point positive ; n=62 ; EPN , end-point negative ; n=113 ) . RESULTS Initial characteristics did not differ between EPP and EPN . Multivariate cox regression analysis revealed that change of pVO2 ( EPP : -0.6+/-2.6 ml/kg min ; EPN : + 2.5+/-3.3 ml/kg min ; p<0.001 ) was independent to pVO2 , LVEF , NTproBNP and NYHA at V2 for prediction of the combined end-point during follow-up . An increase of pVO2 by 10 % was identified as an adequate cut-off value for risk stratification and ROC- analysis showed the significant incremental prognostic value of the determination of pVO2 changes in combination with pVO2 . CONCLUSIONS Serial measurements of pVO2 yield additional information for risk stratification in clinical ly homogenous CHF patients receiving BBL . This is the first study demonstrating this fact within a narrow predefined interval with all patients on BBL Background —There is evidence that aerobic exercise improves functional capacity in patients with New York Heart Association ( NYHA ) class II and III chronic heart failure . However , it is unknown whether dancing is safe and able to improve functional capacity in patients with chronic heart failure . Methods and Results —We prospect ively studied 130 patients with stable chronic heart failure ( 107 men ; mean age , 59±11 years ) in New York Heart Association class II and III and left ventricle ejection fraction < 40 % . Patients were r and omized to supervised aerobic exercise training at 70 % of peak & OV0312;o2 3 times a week for 8 weeks ( group E , n=44 ) or to a dance protocol of alternate slow ( 5 minutes ) and fast ( 3 minutes ) waltz lasting 21 minutes ( group D , n=44 ) . A group that did not undergo exercise training served as control ( group C , n=42 ) . On study entry and at 8 weeks , all patients underwent cardiopulmonary exercise testing on a cycle ergometer until volitional fatigue , 2D-echo with Doppler , and endothelium-dependent dilation of the brachial artery . Heart rate was 111±15 bpm during exercise training and 113±19 bpm during dancing ( P=0.59 ) . Peak & OV0312;o2 , anaerobic threshold , & OV0312;e/&OV0312;co2 slope , and & OV0312;o2/W slope were all similarly improved in both E and D groups ( + 16 % and 18 % , 20 % and 21 % , 14 % and 15 % , 18 % and 19 % , respectively ; P not significant for all comparisons ; P<0.001 versus controls ) . Endothelium-dependent relaxation was also similarly improved ( group E , from 2.6±1.3 % to 5.2±1.5 % , P<0.001 versus control ; group D , from 2.2±1.4 % to 5.0±1.5 % , P<0.001 versus control for both E and D ) . The change in peak & OV0312;o2 in E and D groups was correlated with changes in peak velocity of early filling wave/peak velocity of late filling ratio ( r=−0.58 , P<0.001 ) and endothelium-dependent dilation ( r=0.64 , P<0.001 ) . Untoward events were rare in both E and D groups . Conclusions —In patients with stable chronic heart failure , waltz dancing is safe and able to improve functional capacity and endothelium-dependent dilation similar to traditional aer OUTPUT: The results suggested that dance therapy compared with control had a positive impact on peak VO2 and HRQOL . Non-significant difference in VO2 peak and HRQOL for participants in the exercise group compared with dance therapy . Conclusions : Dance therapy may improve peak VO2 and HRQOL in patients with chronic heart failure ( CHF ) and could be considered for inclusion in cardiac rehabilitation programmes INPUT: Background —There is evidence that aerobic exercise improves functional capacity in patients with New York Heart Association ( NYHA ) class II and III chronic heart failure . However , it is unknown whether dancing is safe and able to improve functional capacity in patients with chronic heart failure . Methods and Results —We prospect ively studied 130 patients with stable chronic heart failure ( 107 men ; mean age , 59±11 years ) in New York Heart Association class II and III and left ventricle ejection fraction < 40 % . Patients were r and omized to supervised aerobic exercise training at 70 % of peak & OV0312;o2 3 times a week for 8 weeks ( group E , n=44 ) or to a dance protocol of alternate slow ( 5 minutes ) and fast ( 3 minutes ) waltz lasting 21 minutes ( group D , n=44 ) . A group that did not undergo exercise training served as control ( group C , n=42 ) . On study entry and at 8 weeks , all patients underwent cardiopulmonary exercise testing on a cycle ergometer until volitional fatigue , 2D-echo with Doppler , and endothelium-dependent dilation of the brachial artery . Heart rate was 111±15 bpm during exercise training and 113±19 bpm during dancing ( P=0.59 ) . Peak & OV0312;o2 , anaerobic threshold , & OV0312;e/&OV0312;co2 slope , and & OV0312;o2/W slope were all similarly improved in both E and D groups ( + 16 % and 18 % , 20 % and 21 % , 14 % and 15 % , 18 % and 19 % , respectively ; P not significant for all comparisons ; P<0.001 versus controls ) . Endothelium-dependent relaxation was also similarly improved ( group E , from 2.6±1.3 % to 5.2±1.5 % , P<0.001 versus control ; group D , from 2.2±1.4 % to 5.0±1.5 % , P<0.001 versus control for both E and D ) . The change in peak & OV0312;o2 in E and D groups was correlated with changes in peak velocity of early filling wave/peak velocity of late filling ratio ( r=−0.58 , P<0.001 ) and endothelium-dependent dilation ( r=0.64 , P<0.001 ) . Untoward events were rare in both E and D groups . Conclusions —In patients with stable chronic heart failure , waltz dancing is safe and able to improve functional capacity and endothelium-dependent dilation similar to traditional aerobic exercise training . Waltz dancing may be considered in clinical practice in combination with aerobic exercise training or as an alternative to it OBJECTIVE To determine the level of improvement , as regards pain , impact on fibromyalgia and depression , achieved by patients with fibromyalgia by comparing aquatic biodanza and stretching exercises . DESIGN R and omised controlled trial with two intervention groups . LOCATION Five health centres ( Almeria ) . PATIENTS A total of 82 fibromyalgia patients between 18 and 65 years old , diagnosed by American College of Rheumatology criteria , were included , with 12 patients declining to take part in the study . The 70 remaining patients were r and omly assigned to two groups of 35 patients each : aquatic biodanza and stretching exercises . Those who did not attend in at least 14 sessions or changed their treatment during the studio were excluded . The final sample consisted of 19 patients in aquatic biodanza group and 20 in stretching group . The limitations of the study included , the open evaluation design and a sample size reduced by defaults . MAIN MEASURES The outcome measures were sociodemographic data , quality of life ( Fibromyalgia Impact Question naire ) , pain ( McGill-Melzack question naire ; and Visual Analogue Scale ) , pressure algometry ( Wagner FPI10 algometer ) and depression ( Beck Inventory ) . These were carried out before and after a 12-week therapy . RESULTS The mean age of the sample was 55.41 years . The mean period from diagnosis was 13.44 years . The sample consisted mainly of housewives . There were significant differences ( P<.05 ) between groups , in pain ( P<.01 ) , fibromyalgia impact ( P<.01 ) , and depression ( P<.04 ) after the treatment . CONCLUSIONS The biodanza aquatic exercises improve pain and quality of life in fibromyalgia patients The present study has been carried out to investigate the effects of group-based Turkish folkloric dances on physical performance , balance , depression and quality of life ( QoL ) in 40 healthy adult elderly females over the age of 65 years . Subjects were r and omly allocated into Group 1 ( folkloric dance-based exercise ) and Group 2 ( control ) . A 8-week dance-based exercise program was performed . Outcome measures included a 20-m walk test , a 6-min walk test , stair climbing and chair rise time , Berg balance scale ( BBS ) , the Medical Outcomes Study ( MOS ) 36-item short form health survey ( SF-36 ) , and geriatric depression scale ( GDS ) question naires . In Group 1 statistically significant improvements were found in most of the physical performance tests , BBS and some SF-36 subscales after the exercise ( p<0.05 ) . In the Group 2 there was no clinical ly significant change in the variables . Comparing the groups , significant improvements in favor of Group 1 have emerged in most of the functional performance tests , in some of the SF-36 subscales and BBS score ( p<0.05 ) . We achieved improvements in physical performance , balance and QoL in elderly females . Application of folkloric dance specific to countries as an exercise program for elderly people may be helpful OBJECTIVE To evaluate the effect of a dance-based therapy OUTPUT:

To our knowledge this will be the first attempt to systematic ally identify knowledge of dance as a potential intervention for adults with fibromyalgia . This scoping review offers a feasible means for describing the evidence specific to dance and fibromyalgia ; results will provide unique insights concerning the breadth and depth of literature in the area . An analysis of this body of literature as a whole may reveal new research directions or unknown ways this intervention could strengthen current management approaches of the disease

MS2_dynamic_1_shot89

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Telehome care has been proposed as a solution to the challenges of providing effective and affordable care for patients with diabetes . METHODS A total of 100 adult patients with type 2 diabetes-divided between insulin and noninsulin requiring-was enrolled in a r and omized , controlled trial aim ed at investigating the effects of telehome monitoring . The experimental group ( n = 50 ) received an in-home wireless glucose monitor and transmitter , whereas the control group ( n = 50 ) was instructed to follow the conventional arrangement . RESULTS There was an overall reduction in HbA1c values in both experimental and control groups after 6 months . A significant difference in HbA1c values between the groups was observed only among the noninsulin-requiring patients ( decline from 6.95 % ± 0.82 % to 6.66 % ± 0.86 % in IB vs. 7.21 % ± 2.02 % to 7.2 % ± 1.86 % in IIB ; p = 0.02 ) . The experimental group reported considerably less hyperglycemic and hypoglycemic events . The profile of the patient who benefited the most from telemonitoring consisted of older , more educated patient who had acquired the disease relatively recently , and who spends most of the time at home . The experimental group had higher overall scores on quality of life measures and sense of control over diabetes . There was a positive association between educational attainment and ability to use the telemonitoring system without help ( p = 0.045 ) . CONCLUSIONS Although not conclusive because of the small sample and short observation period , the study suggests that telehome monitoring is an effective tool in controlling type 2 diabetes in a primary care setting OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P < 0.05 ) when compared with education and usual care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P < 0.05 ) . A larger number of website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P < 0.02 ) . Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P < 0.01 ) . HDL cholesterol rose and triglycerides fell in the web-based group ( P < 0.05 ) . CONCLUSIONS Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes Purpose The purpose of this study is to investigate the impact of a 6-month Web-based intervention on the psychosocial well-being of older adults with diabetes . Methods This study was a r and omized controlled trial ( N = 62 ) comparing the effects of a 6-month Web-based intervention plus usual care with usual care alone among adults aged 60 years or older with diabetes . The outcomes included quality of life , depression , social support , and self-efficacy . Results The intervention group showed significant improvement , F(4.48 ) = 4.03 P = .007 , when compared with the control group on measures of depression , quality of life , social support , and self-efficacy when controlling for all baseline outcome variables ( age , gender , and number of years with diabetes ) . Conclusions These findings provide support for the conclusion that a Web-based intervention is effective in improving the psychosocial well-being of participants at a 6-month follow-up . Future research needs to investigate the long-term effectiveness of Web-based interventions for sustaining psychosocial well-being , including factors that may affect quality of life , such as diabetes-specific beliefs , attitudes , social support , and disease-specific coping skills OBJECTIVE —To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a trial of 83 adults with type 2 diabetes r and omized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004 . All patients had GHb ≥7.0 % , had Web access from home , and could use a computer with English language –based programs . Intervention patients received 12 months of Web-based care management . The Web-based program included patient access to electronic medical records , secure e-mail with providers , feedback on blood glucose readings , an educational Web site , and an interactive online diary for entering information about exercise , diet , and medication . The primary outcome was change in GHb . RESULTS —GHb levels declined by 0.7 % ( 95 % CI 0.2−1.3 ) on average among intervention patients compared with usual-care patients . Systolic blood pressure , diastolic blood pressure , total cholesterol levels , and use of in-person health care services did not differ between the two groups . CONCLUSIONS —Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes OBJECTIVE To assess the effect OUTPUT: Internet blood glucose monitoring systems ( IBGMS ) are associated with improved glycemic control in patients with type 2 diabetes ( T2D ) who are pharmacologically managed , using oral agents or insulin . IBGMS improves glycemic levels in patients with type 1 diabetes ( T1D ) . IBGMS has not led to increased hypoglycemia . Mechanisms underlying IBGMS-associated glycemic improvement extend beyond optimizing insulin dose titration . The most important effects seem to be associated with increased patient self-motivation and improved patient-physician communication . IBGMS have been recommended in clinical practice guidelines , and their effectiveness and safety in trials suggest that this approach is appropriate for patients with T1D or T2D INPUT: Background To determine whether an internet-based mentoring program can improve glycemic control in subjects with type 1 diabetes mellitus ( T1DM ) . Methods Subjects with T1DM on intensive insulin therapy and with hemoglobin A1c ( HbA1c ) ≥8.0 % were r and omized to mentored ( glucometer transmission with feedback from mentors ) or control ( glucometer transmission without feedback ) groups and were examined for 12 weeks . Five mentors were interviewed and selected , of which two were T1DM patients themselves and three were parents with at least one child diagnosed with T1DM since more than 5 years ago . Results A total of 57 T1DM adult subjects with a mean duration after being diagnosed with diabetes of 7.4 years were recruited from Samsung Medical Center . Unfortunately , the mentored group failed to show significant improvements in HbA1c levels or other outcomes , including the quality of life , after completion of the study . However , the mentored group monitored their blood glucose ( 1.41 vs. 0.30 ) and logged into our website ( http://ubisens.co.kr/ ) more frequently ( 20.59 times vs. 5.07 times ) than the control group . Conclusion A 12-week internet-based mentoring program for T1DM patients with inadequate glycemic control did not prove to be superior to the usual follow-up . However , the noted increase in the subjects ' frequency of blood glucose monitoring may lead to clinical benefits AIMS To assess Sweet Talk , a text-messaging support system design ed to enhance self-efficacy , facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes . METHODS One hundred and twenty-six patients fulfilled the eligibility criteria ; Type 1 diabetes for > 1 year , on conventional insulin therapy , aged 8 - 18 years . Ninety-two patients were r and omized to conventional insulin therapy ( n = 28 ) , conventional therapy and Sweet Talk ( n = 33 ) or intensive insulin therapy and Sweet Talk ( n = 31 ) . Goal - setting at clinic visits was reinforced by daily text-messages from the Sweet Talk software system , containing personalized goal -specific prompts and messages tailored to patients ' age , sex and insulin regimen . RESULTS HbA(1c ) did not change in patients on conventional therapy without or with Sweet Talk ( 10.3 + /- 1.7 vs. 10.1 + /- 1.7 % ) , but improved in patients r and omized to intensive therapy and Sweet Talk ( 9.2 + /- 2.2 % , 95 % CI -1.9 , -0.5 , P < 0.001 ) . Sweet Talk was associated with improvement in diabetes self-efficacy ( conventional therapy 56.0 + /- 13.7 , conventional therapy plus Sweet Talk 62.1 + /- 6.6 , 95 % CI + 2.6 , + 7.5 , P = 0.003 ) and self-reported adherence ( conventional therapy 70.4 + /- 20.0 , conventional therapy plus Sweet Talk 77.2 + /- 16.1 , 95 % CI + 0.4 , + 17.4 , P = 0.042 ) . When surveyed , 82 % of patients felt that Sweet Talk had improved their diabetes self-management and 90 % wanted to continue receiving messages . CONCLUSIONS Sweet Talk was associated with improved self-efficacy and adherence ; engaging a classically difficult to reach group of young people . While Sweet Talk alone did not improve glycaemic control , it may have had a role in supporting the introduction of intensive insulin therapy . Scheduled , tailored text messaging offers an innovative means of supporting adolescents with diabetes and could be adapted for other health-care setting s and chronic diseases BACKGROUND Telehome care has been proposed as a solution to the challenges of providing effective and affordable care for patients with diabetes . METHODS A total of 100 adult patients with type 2 diabetes-divided between insulin and noninsulin requiring-was enrolled in a r and omized , controlled trial aim ed at investigating the effects of telehome monitoring . The experimental group ( n = 50 ) received an in-home wireless glucose monitor and transmitter , whereas the control group ( n = 50 ) was instructed to follow the conventional arrangement . RESULTS There was an overall reduction in HbA1c values in both experimental and control groups after 6 months . A significant difference in HbA1c values between the groups was observed only among the noninsulin-requiring patients ( decline from 6.95 % ± 0.82 % to 6.66 % ± 0.86 % in IB vs. 7.21 % ± 2.02 % to 7.2 % ± 1.86 % in IIB ; p = 0.02 ) . The experimental group reported considerably less hyperglycemic and hypoglycemic events . The profile of the patient who benefited the most from telemonitoring consisted of older , more educated patient who had acquired the disease relatively recently , and who spends most of the time at home . The experimental group had higher overall scores on quality of life measures and sense of control over diabetes . There was a positive association between educational attainment and ability to use the telemonitoring system without help ( p = 0.045 ) . CONCLUSIONS Although not conclusive because of the small sample and short observation period , the study suggests that telehome monitoring is an effective tool in controlling type 2 diabetes in a primary care setting OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , OUTPUT:

The narrative synthesis provided mixed effects of CHITs on other clinical , psychosocial , behavioral , and knowledge outcomes . Conclusions The use of CHITs appears to be more effective than usual care in improving glycemic control for patients with diabetes . However , their effectiveness did not remain consistent over time and in other patient outcomes .

MS2_dynamic_1_shot90

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The conventional treatment of chronic anal fissure is lateral sphincterotomy ( LAS ) . The alternative options of tailored sphincterotomy ( TS ) and ‘ chemical sphincterotomy ’ using medication such as nifedipine have recently become available The extent of sphincter division by the subcutaneous or the open technique is examined by comparing the change in anal canal pressure after either method of sphincterotomy in twenty‐eight patients with chronic anal fissure r and omly allocated . In all patients the fissures healed at one month with significant reduction ( P < 0.01 ) of anal canal pressures to 52 ( 17–75 ) cmH2O after subcutaneous and 47.5 ( 35–100 ) cmH2O after open sphincterotomy , a 51 ( 22–77 ) and 50 ( 11–68 ) per cent reduction of their respective pre‐operative measurements . Adequate sphincterotomy can be achieved by both techniques BACKGROUND Anal fissure is a frequent proctologic disease . There are many and various treatments adopted to cure this disease . In this study we applied radiofrequencies to the subcutaneous lateral internal sphincterotomy and we compared the techniques in a r and omised trial . METHODS Patients have been r and omized in two groups : in group A 18 patients underwent subcutaneous lateral internal sphincterotomy using radiofrequency bistoury while in group B 17 patients underwent the conventional lateral internal sphincterotomy described by Parks . RESULTS The mean values for operative time were 6.6 min for group A and 9.1 min for group B. According to pain score , patients ' mean values were 1.8 for group A and 1.9 for group B. Healing of the wound was faster in group A than group B , while healing of the anal fissure was approximately the same . CONCLUSION Lateral subcutaneous sphincterotomy is the most advantageous operation for the treatment of the idiopathic anal fissure . The radiofrequency bistoury easies the procedure , lessens operating times and healing process of the surgical wounds Nitric oxide donors , such as isosorbide dinitrate ointment ( ISDN ) , are considered as first‐choice agents in the treatment of chronic anal fissure . Injection with botulinum toxin A in the internal anal sphincter is often used as a second‐line therapy , although it may give better results and fewer side effects than nitric oxide donors . The aim of this r and omized clinical trial was to investigate whether botulinum toxin A ( Dysport ® ) is more effective than ISDN in the primary treatment of chronic anal fissure Background Lateral internal sphincterotomy has been proven highly effective in curing anal fissure but with a high incidence of postoperative incontinence . Objective We compared conventional lateral internal sphincterotomy , V-Y advancement flap , and combined tailored lateral internal sphincterotomy with V-Y advancement flap in treating anal fissure . Patients Consecutive patients treated for anal fissure at our colorectal unit were evaluated for inclusion . Participants were r and omly allocated to receive conventional sphincterotomy ( GI ) , V-Y advancement flap ( GII ) , or combined tailored lateral sphincterotomy with V-Y advancement l flap (GIII).Main Outcome Measures The primary outcome measure was the incontinence rate ; secondary outcomes included healing rate , operative time , anal manometery , and recurrence rate . Results One hundred fifty patients with chronic anal fissure were r and omized . Healing rate after 1 year was 84 % in GI , 48 % in GII , and 94 % in GIII , respectively ( P = 0.001 ) . The recurrence rate was 4 % in G1 , 22 % in GII , and 2 % in GIII ( P = 0.01 ) . Incontinence rate was 14 % in GI , 0 % in GII , and 2 % in GIII ( P = 0.03 ) . Conclusion Although all three procedures are simple and easy to perform , tailored lateral internal sphincterotomy with V-YF appears to produce the greatest healing rate , with the fewest complications and less rate of recurrence Purpose . This study was design ed to evaluate the role of maintenance therapy with partially hydrolyzed guar gum ( PHGG ) after topical application of glyceryl trinitrate ( GTN ) in the conservative treatment of chronic anal fissure ( CAF ) . Methods . From all the patients with CAF observed during the study period , 165 subjects with healed CAF after st and ard therapy with topical GTN 0.4 % ointment were r and omized to receive ( group II ) or not ( group I ) maintenance therapy with PHGG for 10 months . Clinical and manometric followup was carried out 6 and 12 months after treatment . Results . At six-month followup , median visual analogue scale score was significantly higher in group I if compared with group II . The success and recurrence rate at 12-month followup were , respectively , 38.3 % ( 28/73 ) in group I versus 58.5 % ( 41/70 ) in group II ( P = 0.019 ; Fisher 's exact test ) and 30.2 % ( 13/43 ) in group I versus 14.5 % ( 7/48 ) in group II ( P = 0.0047 ; Fisher 's exact test ) . Conclusion . The maintenance therapy with PHGG in patients with healed CAF after chemical sphincterotomy by topical application of GTN 0.4 % ointment seems associated with a significant reduction of recurrence rate and with a significant increase of success rate at 12-month followup PURPOSE : Internal sphincterotomy remains the “ gold st and ard ” for treatment of OUTPUT: Conclusions LIS is superior to non-surgical therapies in achieving sustained cure of fissure . Calcium channel blockers were more effective than GTN and with less risk of headache , but with only a low quality of evidence . Among the surgical studies , manual anal stretch performed worse than LIS in the treatment of chronic anal fissure in adults . For those patients requiring surgery for anal fissure , open LIS and closed LIS appear to be equally efficacious , with a moderate GRADE quality of evidence . INPUT: The extent of sphincter division by the subcutaneous or the open technique is examined by comparing the change in anal canal pressure after either method of sphincterotomy in twenty‐eight patients with chronic anal fissure r and omly allocated . In all patients the fissures healed at one month with significant reduction ( P < 0.01 ) of anal canal pressures to 52 ( 17–75 ) cmH2O after subcutaneous and 47.5 ( 35–100 ) cmH2O after open sphincterotomy , a 51 ( 22–77 ) and 50 ( 11–68 ) per cent reduction of their respective pre‐operative measurements . Adequate sphincterotomy can be achieved by both techniques BACKGROUND Anal fissure is a frequent proctologic disease . There are many and various treatments adopted to cure this disease . In this study we applied radiofrequencies to the subcutaneous lateral internal sphincterotomy and we compared the techniques in a r and omised trial . METHODS Patients have been r and omized in two groups : in group A 18 patients underwent subcutaneous lateral internal sphincterotomy using radiofrequency bistoury while in group B 17 patients underwent the conventional lateral internal sphincterotomy described by Parks . RESULTS The mean values for operative time were 6.6 min for group A and 9.1 min for group B. According to pain score , patients ' mean values were 1.8 for group A and 1.9 for group B. Healing of the wound was faster in group A than group B , while healing of the anal fissure was approximately the same . CONCLUSION Lateral subcutaneous sphincterotomy is the most advantageous operation for the treatment of the idiopathic anal fissure . The radiofrequency bistoury easies the procedure , lessens operating times and healing process of the surgical wounds PURPOSE : Internal sphincterotomy remains the “ gold st and ard ” for treatment of anal fissure but is associated with a risk of imperfect continence . Recent studies have suggested that surgical technique ( open vs. closed ) may influence incontinence rates after sphincterotomy . This study was design ed to assess the short-term and long-term incidence of incontinence after open and closed internal sphincterotomy . METHODS : Seventy-nine patients were r and omly assigned to open or closed internal sphincterotomy , performed in st and ardized fashion by trainee staff . St and ardized question naires assessing continence ( modified Wexner score ) were administered preoperatively and at 1 , 6 , and 52 weeks . Postoperative stay , pain scores , complications , and fissure healing were prospect ively assessed by an independent observer . RESULTS : Three patients were lost to follow-up , leaving 36 closed ( 16 males ; mean age , 45.1 years ) and 40 open ( 21 males ; mean age , 47.9 years ) internal sphincterotomy patients for assessment . All operations were performed as day case procedures with no readmissions . At six weeks postoperative , 96 percent of fissures had healed . There were no significant differences in pain scores between closed and open internal sphincterotomy at Day 1 or Day 3 postoperative . New incontinence of any grade was seen in 6.8 percent of patients at 52-week follow-up . Three patients ( 4.1 percent , 1 closed , 2 open ) suffered major incontinence at 52 weeks . There were no significant differences in continence at 1 , 6 , or 52 weeks , although more open patients experienced minor imperfections at 1 week . CONCLUSIONS : Incontinence after internal sphincterotomy is not insignificant . The technique ( closed vs. open ) does not seem to influence incontinence rates Twenty patients with chronic anal fissure were r and omized into two groups . Ten patients were treated with lateral subcutaneous sphincterotomy and 10 with anal dilatation . Anal dilatation was carried out preoperatively , and at 1 and 3 months after the operation in all patients . Preoperatively there was a significantly increased maximal resting pressure in the 20 fissure patients ( 80 mmHg median ) compared with 20 control subjects ( 50 mmHg median ) . Postoperatively a significant decrease in pressure occurred in the dilated group ( 49 mmHg medianp<0.05 ) , whereas the pressure was not significantly reduced in the group that underwent sphincterotomy ( 65 mmHg medianp<0.05 ) . At 1 year three patients complained of recurrent symptoms of anal fissure in the dilated group compared with one in the sphincterotomy group . Minor continence disturbance was noted in two patients in both groups PURPOSE Conventional practice in colorectal surgery involves stoma education being imparted postoperatively . Proficiency in stoma management often delays patients ’ discharge following colorectal surgery . The aim of this r and omized , controlled trial was to compare preoperative intensive , community-based stoma education with conventional postoperative stoma education after elective colorectal surgery . METHODS Forty-two elective colorectal patients requiring a stoma were r and omized into an intensive preoperative teaching ( study ) or postoperative ( control ) group . Intervention for the study group included two preoperative visits in the community during which patients were taught with audiovisual aids to use and change the stoma pouching system . Goal -directed postoperative stoma education was st and ardized for both groups . Outcomes measured included time to stoma proficiency , postoperative hospital stay , unplanned stoma-related interventions in the community within six weeks of discharge , and preoperative and postoperative hospital anxiety and depression scores . Cost-effectiveness of the intervention was also evaluated . RESULTS All outcomes measured were improved in the study group , including time to stoma proficiency(5.5 vs. 9 days ; OUTPUT:

Anal stretch has a higher risk of fissure persistence than internal sphincterotomy and also a significantly higher risk of minor incontinence than sphincterotomy . The combined results of open versus closed partial lateral internal sphincterotomy show little difference between the two procedures both in fissure persistence and risk of incontinence . AUTHORS ' CONCLUSIONS Anal stretch and posterior midline internal sphincterotomy should probably be ab and oned in the treatment of chronic anal fissure in adults . For those patients requiring surgery for anal fissure , open and closed partial lateral internal sphincterotomy appear to be equally efficacious .

MS2_dynamic_1_shot91

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND The effects of cholesterol-lowering treatment with statins on mortality and risk of cancer beyond the usual 5 - 6-year trial periods are unknown . We extended post-trial follow-up of participants in the Sc and inavian Simvastatin Survival Study ( 4S ) to investigate cause-specific mortality and incidence of cancer 5 years after closure of the trial . METHODS 4S was a r and omised double-blind trial of simvastatin or placebo in patients with coronary heart disease , serum total cholesterol 5.5 - 8.0 mmol/L , and serum triglycerides 2.5 mmol/L or lower . The double-blind period lasted for a median of 5.4 years ( range for survivors 4.9 - 6.3 ) and ended in 1994 . After the trial , most patients in both groups received open-label lipid-lowering treatment . National registers were used to assess mortality and causes of death and cancer incidence in the original treatment groups for a median total follow-up time of 10.4 years ( range for survivors 9.9 - 11.3 ) . Analysis was by intention to treat . FINDINGS 414 patients originally allocated simvastatin and 468 assigned placebo died during the 10.4-year follow-up ( relative risk 0.85 [ 95 % CI 0.74 - 0.97 ] , p=0.02 ) , a difference largely attributable to lower coronary mortality in the simvastatin group ( 238 vs 300 deaths ; 0.76 [ 0.64 - 0.90 ] , p=0.0018 ) . 85 cancer deaths arose in the simvastatin group versus 100 in the placebo group ( 0.81 [ 0.60 - 1.08 ] , p=0.14 ) , and 227 incident cancers were reported in the simvastin group versus 248 in the placebo group ( 0.88 [ 0.73 - 1.05 ] , p=0.15 ) . Incidence of any specific type of cancer did not rise in the simvastatin group . INTERPRETATION Simvastatin treatment for 5 years in a placebo-controlled trial , followed by open-label statin therapy , was associated with survival benefit over 10 years of follow-up compared with open-label statin therapy for the past 5 years only . No difference was noted in mortality from and incidence of cancer between the original simvastatin group and placebo group Background —Therapeutic decisions regarding pharmacological therapy should be based on safety and tolerability as well as efficacy data . Clinical trials design ed to assess efficacy are often insufficiently powered to generate reliable safety data . Methods and Results —The West of Scotl and Coronary Prevention Study ( WOSCOPS ) , the Cholesterol and Recurrent Events ( CARE ) , and Long-term Intervention with Pravastatin in Ischemic Disease ( LIPID ) studies collectively accumulated > 112 000 person-years of exposure in double-blind r and omized trials comparing placebo and pravastatin ( 40 mg once daily ) . During 5 years of exposure , the incidence of fatal and nonfatal cancers was similar between pravastatin and placebo groups . No differences in noncardiovascular serious adverse events were detected . With > 243 000 blood sample analyses , the percentage of patients with any abnormal liver function test after baseline sampling was similar ( > 3 × the upper limit of normal for alanine aminotransferase : 128 [ 1.4 % ] versus 131 [ 1.4 % ] patients for pravastatin versus placebo , respectively ) . Study medication was withdrawn in 3 pravastatin and 7 placebo patients due to creatine phosphokinase elevations ; no cases of mild or severe myopathy were reported . A Cox regression model considering treatment group , age , diabetes , smoking , whether primary or secondary prevention study , and cardiovascular serious adverse events indicates that the likelihood of discontinuing pravastatin was less than placebo . Conclusions —This prospect i ve analysis indicates that during prolonged exposure , 40 mg of pravastatin is well tolerated , with no excess of noncardiovascular serious adverse events , including liver function abnormalities and laboratory and clinical evidence for myositis . These extensive safety and tolerability data provide important information for therapeutic decisions regarding this pharmacological agent The Sc and inavian Simvastatin Survival Study ( 4S ) and other r and omized clinical trials have demonstrated that cholesterol-lowering treatment with statins improves prognosis in patients with coronary atherosclerosis compared with placebo . The effect of therapy with statins beyond the typical 5 to 6 years ' duration of the trials , in particular regarding the risk of cancer , has not been investigated . This study examines the long-term effects of simvastatin for up to 8 years on cause-specific mortality in patients with coronary heart disease ( CHD ) . We performed an observational , government registry-based study of mortality in the groups originally r and omized to simvastatin or placebo in the 4S over an additional 2-year follow-up period , so that the median total follow-up period was 7.4 years ( range 6.9 to 8.3 in surviving patients ) . R and omization took place at outpatient clinics at 94 clinical centers in Denmark , Finl and , Icel and , Norway , and Sweden from 1988 to 1989 . Of 4,444 patients with CHD , 2,223 and 2,221 were r and omized to treatment with placebo or simvastatin therapy , respectively . Patients received treatment with simvastatin , starting at 20 mg/day , with titration to 40 mg/day at 12 or 24 weeks if total OUTPUT: The melanoma outcomes data collected in this review of RCTs of statins and fibrates does not exclude the possibility that these drugs prevent melanoma . Until further evidence is established , limiting exposure to ultraviolet radiation remains the most effective way to reduce the risk of melanoma INPUT: BACKGROUND The effects of cholesterol-lowering treatment with statins on mortality and risk of cancer beyond the usual 5 - 6-year trial periods are unknown . We extended post-trial follow-up of participants in the Sc and inavian Simvastatin Survival Study ( 4S ) to investigate cause-specific mortality and incidence of cancer 5 years after closure of the trial . METHODS 4S was a r and omised double-blind trial of simvastatin or placebo in patients with coronary heart disease , serum total cholesterol 5.5 - 8.0 mmol/L , and serum triglycerides 2.5 mmol/L or lower . The double-blind period lasted for a median of 5.4 years ( range for survivors 4.9 - 6.3 ) and ended in 1994 . After the trial , most patients in both groups received open-label lipid-lowering treatment . National registers were used to assess mortality and causes of death and cancer incidence in the original treatment groups for a median total follow-up time of 10.4 years ( range for survivors 9.9 - 11.3 ) . Analysis was by intention to treat . FINDINGS 414 patients originally allocated simvastatin and 468 assigned placebo died during the 10.4-year follow-up ( relative risk 0.85 [ 95 % CI 0.74 - 0.97 ] , p=0.02 ) , a difference largely attributable to lower coronary mortality in the simvastatin group ( 238 vs 300 deaths ; 0.76 [ 0.64 - 0.90 ] , p=0.0018 ) . 85 cancer deaths arose in the simvastatin group versus 100 in the placebo group ( 0.81 [ 0.60 - 1.08 ] , p=0.14 ) , and 227 incident cancers were reported in the simvastin group versus 248 in the placebo group ( 0.88 [ 0.73 - 1.05 ] , p=0.15 ) . Incidence of any specific type of cancer did not rise in the simvastatin group . INTERPRETATION Simvastatin treatment for 5 years in a placebo-controlled trial , followed by open-label statin therapy , was associated with survival benefit over 10 years of follow-up compared with open-label statin therapy for the past 5 years only . No difference was noted in mortality from and incidence of cancer between the original simvastatin group and placebo group BACKGROUND The PREVEND IT investigated whether treatment targeted at lowering urinary albumin excretion ( UAE ) would reduce adverse cardiovascular events . We obtained extended follow-up data to approximately 10 years to investigate the long-term effects of fosinopril 20 mg and pravastatin 40 mg on cardiovascular outcomes in subjects with UAE > 15 mg per 24 hours . METHODS The original PREVEND IT consisted of 864 participants and 839 survivors after 4 years . For every survivor , the primary end point determined by the combined incidence of cardiovascular mortality and hospitalization for cardiovascular morbidity was registered in several national data bases and electronic hospital systems . RESULTS Mean total follow-up of the extended PREVEND IT was 9.5 years ( range 9.4 - 10.7 years ) . Four years of treatment with fosinopril was not associated with a reduction in the primary end point compared with placebo ( hazard ratio 0.87 , 95 % CI 0.61 - 1.24 [ P = .42 ] ) during long-term follow-up . After 9.5 years , subjects with a baseline UAE in the upper quintile ( > 50 mg/24 hours ) had a total event rate of 29.5 % and were at a higher risk for developing cardiovascular disease compared with less UAE ( hazard ratio 2.03 , 95 % CI 1.38 - 2.97 [ P ≤ .01 ] ) . In addition , 4 years of fosinopril treatment result ed in a risk reduction of 45 % ( 95 % CI 6%-75 % [ P = .04 ] ) in this group compared with placebo . Subjects originally assigned to pravastatin had no overall risk reduction in the primary end point ( P = .99 ) . CONCLUSIONS Elevated UAE is associated with increased cardiovascular mortality and morbidity after 9.5 years of follow-up , with a doubling of the risk if the UAE is > 50 mg per 24 hours . In this group , the benefits of 4-year treatment with fosinopril were sustained during posttrial follow-up for cardiovascular mortality and morbidity . We propose that UAE be used to estimate risk in the general population and that large clinical trials be design ed to confirm the hypothesis that angiotensin-converting enzyme-inhibitor treatment may be beneficial in patients with mildly elevated UAE despite the absence of other comorbidities Background The PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) , a placebo-controlled trial of pravastatin , demonstrated a 19 % reduction in coronary outcomes ( p = 0.006 ) after a mean of 3.2 years , with no impact on stroke outcomes or all-cause mortality . However , there was a suggestion of increased cancer risk . Our aim is to determine the long-term benefits and safety of pravastatin treatment in older people using post-trial follow-up of the PROSPER participants . Methods 5,804 ( 2,520 Scottish ) men and women aged 70–82 years with either pre-existing vascular disease or increased risk of such disease because of smoking , hypertension or diabetes , were r and omised to 40 mg pravastatin or matching placebo . Using record linkage to routin OUTPUT:

Results : BP and lipid levels tended to come together soon in the post-trial period . Conclusion : Benefits of BPL and lipid lowering on all-cause and cardiovascular mortality were persistent , but attenuated , after discontinuation of r and omized treatment , indicating the importance of continuing therapy

MS2_dynamic_1_shot92

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: BACKGROUND Little is known about how the intensity of exercise influences cardiovascular fitness and body composition , especially in obese adolescents . OBJECTIVE Our goal was to determine the effects of physical training intensity on the cardiovascular fitness , percentage of body fat ( % BF ) , and visceral adipose tissue ( VAT ) of obese adolescents . DESIGN Obese 13 - 16-y-olds ( n = 80 ) were assigned to 1 ) biweekly lifestyle education ( LSE ) , 2 ) LSE + moderate-intensity physical training , or 3 ) LSE + high-intensity physical training . The intervention lasted 8 mo . Physical training was offered 5 d/wk , and the target energy expenditure for all subjects in physical training groups was 1047 kJ ( 250 kcal)/session . Cardiovascular fitness was measured with a multistage treadmill test , % BF with dual-energy X-ray absorptiometry , and VAT with magnetic resonance imaging . RESULTS The increase in cardiovascular fitness in the high-intensity physical training group , but not in the moderate-intensity group , was significantly greater than that in the LSE alone group ( P = 0.009 ) ; no other comparisons of the 3 groups were significant . Compared with the LSE alone group , a group composed of subjects in both physical training groups combined who attended training sessions > or=2 d/wk showed favorable changes in cardiovascular fitness ( P < 0.001 ) , % BF ( P = 0.001 ) , and VAT ( P = 0.029 ) . We found no evidence that the high-intensity physical training was more effective than the moderate-intensity physical training in enhancing body composition . CONCLUSIONS The cardiovascular fitness of obese adolescents was significantly improved by physical training , especially high-intensity physical training . The physical training also reduced both visceral and total-body adiposity , but there was no clear effect of the intensity of physical training OBJECTIVE A r and omized controlled trial tested the efficacy of an internet-based lifestyle behavior modification program for African-American girls over a 2-year period of intervention . RESEARCH METHODS AND PROCEDURES Fifty-seven overweight ( mean BMI percentile , 98.3 ) African-American girls ( mean age , 13.2 years ) were r and omly assigned to an interactive behavioral internet program or an internet health education program , the control condition . Overweight parents were also participants in the study . Forty adolescent-parent dyads ( 70 % ) completed the 2-year trial . Outcome data including BMI , body weight , body composition , and weight loss behaviors were collected at baseline and at 6-month intervals . A computer server tracked use of the web sites . RESULTS An intention-to-treat statistical approach was used , with the last observation carried forward . In comparison with the control condition , adolescents in the behavioral program lost more mean body fat ( BF ) ( -1.12 + /- 0.47 % vs. 0.43 + /- 0.47 % BF , p < 0.05 ) , and parents in the behavioral program lost significantly more mean body weight ( -2.43 + /- 0.66 vs. -0.35 + /- 0.64 kg , p < 0.05 ) during the first 6 months . This weight loss was regained over the next 18 months . After 2 years , differences in fat for adolescents ( -0.08 + /- 0.71 % vs. 0.84 + /- 0.72 % BF ) and weight for parents ( -1.1 + /- 0.91 vs. -0.60 + /- 0.89 kg ) did not differ between the behavioral and control programs . DISCUSSION An internet-based weight management program for African-American adolescent girls and their parents result ed in weight loss during the first 6 months but did not yield long-term loss due to reduced use of the web site over time Objective : Since peers have such an important influence on adolescents , we evaluated the efficacy of adding peer-based ‘ adventure therapy ’ to a st and ard cognitive-behavioral weight control program for overweight adolescents . Methods : Adolescents ( N=76 ) aged 13–16 years and 20 to 80 % overweight ( M=60.56 % , s.d.=15.17 % ) , were r and omly assigned to one of two treatment conditions : cognitive-behavioral group treatment with ‘ adventure therapy ’ similar to Outward Bound ® ( cognitive-behavioral treatment with peer-enhanced adventure therapy ( CBT+PEAT ) ) or cognitive-behavioral group treatment with aerobic exercise ( CBT+EXER ) . Anthropometric and psychosocial measures were obtained at baseline , at the end of the 16-week intervention , and at 10 months following r and omization . Results : Adolescents assigned to both treatment conditions demonstrated significant weight loss over time , F=29.06 , df=2 , 53 , P<0.01 . Average weight loss did not differ significantly between groups ( −5.31 kg for CBT+PEAT and −3.20 kg for CBT+EXER ) at the end of treatment . There was a significant difference in the percentage of participants maintaining a minimum 4.5 kg ( 10 pounds ) weight loss ( 35 % in the CBT+PEAT condition vs 12 % in the CBT+EXER condition , P=0.042 ) 10 months from r and omization . We also observed a significant age by treatment group interaction , such that older adolescents r and omized to CBT+PEAT demonstrated more than four times the weight loss of older adolescents assigned to CBT+EXER ( M=−7.86 kg vs M=−1.72 kg ) at the end of treatment . Conclusions : Peer-based ‘ OUTPUT: RESULTS Due to a lack of consistency among the studies regarding methods and rigor of the studies , the evidence is not entirely clear on the best multicomponent program for addressing overweight in middle adolescents . The success of an intervention was associated with the dose of the intervention received by the adolescent and parent . A structured program addressing nutrition , physical activity , and behavioral skills appears to be efficacious in reducing weight and cardiovascular risk factors . INPUT: BACKGROUND Little is known about how the intensity of exercise influences cardiovascular fitness and body composition , especially in obese adolescents . OBJECTIVE Our goal was to determine the effects of physical training intensity on the cardiovascular fitness , percentage of body fat ( % BF ) , and visceral adipose tissue ( VAT ) of obese adolescents . DESIGN Obese 13 - 16-y-olds ( n = 80 ) were assigned to 1 ) biweekly lifestyle education ( LSE ) , 2 ) LSE + moderate-intensity physical training , or 3 ) LSE + high-intensity physical training . The intervention lasted 8 mo . Physical training was offered 5 d/wk , and the target energy expenditure for all subjects in physical training groups was 1047 kJ ( 250 kcal)/session . Cardiovascular fitness was measured with a multistage treadmill test , % BF with dual-energy X-ray absorptiometry , and VAT with magnetic resonance imaging . RESULTS The increase in cardiovascular fitness in the high-intensity physical training group , but not in the moderate-intensity group , was significantly greater than that in the LSE alone group ( P = 0.009 ) ; no other comparisons of the 3 groups were significant . Compared with the LSE alone group , a group composed of subjects in both physical training groups combined who attended training sessions > or=2 d/wk showed favorable changes in cardiovascular fitness ( P < 0.001 ) , % BF ( P = 0.001 ) , and VAT ( P = 0.029 ) . We found no evidence that the high-intensity physical training was more effective than the moderate-intensity physical training in enhancing body composition . CONCLUSIONS The cardiovascular fitness of obese adolescents was significantly improved by physical training , especially high-intensity physical training . The physical training also reduced both visceral and total-body adiposity , but there was no clear effect of the intensity of physical training Exercise during growth has a positive influence on bone mineral accrual , yet little is known about how bone geometry and strength adapt to loading during growth . Our primary objective was to compare changes in proximal femur bone geometry and strength between 31 prepubertal ( Tanner Stage 1 ) boys who participated in a school-based , high-impact circuit intervention ( 12 min , three times a week ) for 20 months and 33 maturity-matched controls . Our secondary objective was to compare changes in total body ( TB ) , proximal femur ( PF ) , and lumbar spine ( LS ) bone mineral content ( BMC ) and bone area ( BA ) in these groups . We assessed geometric variables and bone strength at the narrow neck ( NN ) , intertrochanteric ( TR ) region , and femoral shaft regions by applying the Hip Structure Analysis program to proximal femur dual energy X-ray absorptiometry scans ( DXA , Hologic QDR 4500 ) . Further , we assessed total body , lumbar spine , and proximal femur BMC and BA by DXA and derived total body lean mass and fat mass from total body scans . Intervention ( 10.2 + /- 0.5 years ) and control boys ( 10.1 + /- 0.5 years ) had similar baseline height ( 140.8 vs. 141.3 cm ) and weight ( 36.9 vs. 35.4 kg ) , and average 20-month physical activity scores ( Physical Activity Question naire for Children , PAQ-C ) and calcium intakes ( 861 vs. 852 mg/day , food frequency question naire ) . Twenty-month height and weight changes were not significantly different between groups ; lean mass changed more ( P < 0.05 ) in intervention boys ( 22.8 % ) than control boys ( 18.6 % ) . At the NN region , intervention boys had greater bone expansion on both the periosteal ( + 2.6 % , P = 0.1 ) and endosteal ( + 2.7 % , P = 0.2 ) surfaces , result ing in significantly greater changes in section modulus ( bone bending strength ) ( + 7.5 % , P = 0.02 , ANCOVA , adjusting for height change , final Tanner Stage , and baseline bone values ) . Changes at the intertrochanteric and femoral shaft regions were not significantly different between groups . Femoral neck ( FN ) BMC changes were significantly greater in intervention boys ( + 4.3 % , P < 0.01 ) ; changes in BA and BMC for other regions were not significantly different between groups . In summary , a school-based , high-impact exercise intervention implemented three times a week for 12 min is an effective strategy for site-specific gains in bone strength at the narrow neck region of the proximal femur Background and design Few studies have investigated the association between maximal cardiorespiratory capacity ( fitness ) and the clustered cardiovascular disease ( CVD ) risk in children and youth from culturally diverse countries . This cross-sectional study examined the association between fitness and clustered CVD risk in children and adolescents from three European countries . Methods Participants were 2845 r and omly selected school children aged 9 or 15 years from Portugal ( n = 944 ) , Denmark ( n = 849 ) and Estonia ( n = 1052 ) . Cardiorespiratory fitness was determined during a maximal test on a cycle ergometer . CVD risk factors selected to assess the degree of clustering were the total cholesterol/high-density lipoprotein cholesterol ratio , plasma triglycerides , insulin resistance ( homeostasis model assessment ) , sum of four skinfolds , and systolic blood pressure . Results There was a strong association between cardiorespiratory fitness and the clustering of CVD risk factors . The odds ratios for clustering in each quartile of fitness , using the quartile with the OUTPUT:

Results Physical activity was associated with numerous health benefits . The dose-response relations observed in observational studies indicate that the more physical activity , the greater the health benefit . Results from experimental studies indicate that even modest amounts of physical activity can have health benefits in high-risk youngsters ( e.g. , obese ) . Vigorous intensity activities may provide even greater benefit . Aerobic-based activities had the greatest health benefit , other than for bone health , in which case high-impact weight bearing activities were required . Some of the health benefits can be achieved through an average of 30 minutes per day . [ Level 2 , Grade A ] .

MS2_dynamic_1_shot93

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To examine the effects of beta-adrenergic blockade on neurohormonal activation in patients with congestive heart failure , 15 men had assessment s of hemodynamics and supine peripheral renin and norepinephrine levels before and after 3 months of oral therapy with bucindolol , a nonselective beta antagonist . At baseline , plasma renin activity did not correlate with any hemodynamic parameter . However , norepinephrine levels had a weak correlation with left ventricular end-diastolic pressure ( r = 0.74 , p less than 0.01 ) , stroke volume index ( r = 0.61 , p less than 0.02 ) and pulmonary vascular resistance ( r = 0.54 , p less than 0.05 ) . Plasma renin decreased with bucindolol therapy , from 11.6 + /- 13.4 to 4.3 + /- 4.1 ng/ml/hour ( mean + /- st and ard deviation ; p less than 0.05 ) , whereas plasma norepinephrine was unchanged , from 403 + /- 231 to 408 + /- 217 pg/ml . A wide diversity of the norepinephrine response to bucindolol was observed with reduction of levels in some patients and elevation in others . Although plasma norepinephrine did not decrease , heart rate tended to decrease ( from 82 + /- 20 vs 73 + /- 11 min-1 , p = 0.059 ) with beta-adrenergic blockade , suggesting neurohormonal antagonism at the receptor level . No changes in I-123 metaiodobenzylguanidine uptake occurred after bucindolol therapy , suggesting unchanged adrenergic uptake of norepinephrine with beta-blocker therapy . Despite reductions in plasma renin activity and the presence of beta blockade , the response of renin or norepinephrine levels to long-term bucindolol therapy did not predict which patients had improved in hemodynamic status ( chi-square = 0.37 for renin , 0.82 for norepinephrine ) . ( ABSTRACT TRUNCATED AT 250 WORDS UNLABELLED Plasma brain natriuretic peptide ( BNP ) level and cardiac autonomic function are closely related to prognosis in patients with heart failure . However , their correlation and incremental prognostic values in human heart failure are unclear . We sought to evaluate the correlation between BNP level and cardiac sympathetic innervation assessed by (123)I-metaiodobenzylguanidine ( (123)I-MIBG ) and the prognostic value of combined assessment of risk factors for mortality in patients with heart failure . METHODS After conventional examinations and measurements of plasma BNP level and heart-to-mediastinum ratio ( HMR ) of cardiac (123)I-MIBG activity , 158 patients with heart failure were prospect ively followed with an endpoint of cardiac death for 16 mo . RESULTS Fifteen deaths due to pump failure and 2 sudden cardiac deaths were documented . Plasma BNP level correlated with HMR significantly but not so tightly ( r = 0.330 , P < 0.0001 ) . Univariate analysis identified plasma BNP level , HMR , chronic renal dysfunction , diabetes mellitus , age , and use of nitrates as significant predictors of fatal pump failure , and multivariate Cox analysis showed that plasma BNP level was the most powerful predictor of cardiac death . Patients with both plasma BNP level of > or = 172 pg/mL and late HMR of < or = 1.74 had a greater annual rate of fatal pump failure than did those without ( 17.5%/y vs. 0%-3.9%/y , respectively ) . The hazard ratio of plasma BNP level ( 7.2 ) or cardiac (123)I-MIBG activity ( 10.1 ) increased to 34.4 when both variables were used , and prevalence of fatal pump failure significantly increased from 22 % to 62.5 % when diabetes mellitus and chronic renal dysfunction were present with a higher plasma BNP level and low cardiac (123)I-MIBG activity . CONCLUSION Plasma BNP level is a stronger predictor than other risk factors for mortality in heart failure patients and is statistically significantly , but roughly , related to cardiac sympathetic nerve innervation . Impaired cardiac sympathetic nerve innervation and the presence of diabetes mellitus and chronic renal dysfunction , however , improve risk stratification of patients with heart failure and increased plasma BNP concentration UNLABELLED We evaluated whether spironolactone would improve cardiac sympathetic nerve activity and symptoms in patients with congestive heart failure ( CHF ) . METHODS Thirty patients with CHF ( left ventricular ejection fraction [ LVEF ] < 40 % ; mean , 30 % + /- 9 % ) were treated with an angiotensin-converting enzyme inhibitor , a loop diuretic , and , in most cases , digoxin . Fifteen patients ( group A ) were assigned to additionally receive spironolactone ( 12.5 - 50 mg/day ) , and the remaining 15 patients ( group B ) continued their current regimen . Patients were studied before and 6 mo after treatment . The delayed heart-to-mediastinum count ratio ( H/M ratio ) , delayed total defect score ( TDS ) , and washout rate ( WR ) were determined from (123)I-meta-iodobenzylguanidine ( MIBG ) images . LVEF was determined by echocardiography , and New York Heart Association ( NYHA ) functional class was estimated . RESULTS Before treatment , LVEF , TDS , H/M ratio , WR , and NYHA functional class were similar in both groups . With OUTPUT: Our results indicate that patients with HF and decreased late H/M or increased myocardial MIBG washout have a worse prognosis compared with those with normal semi-quantitative myocardial MIBG parameters INPUT: It has long been proposed that the renin-angiotensin system exerts a stimulatory influence on the sympathetic nervous system , including augmentation of central sympathetic outflow and presynaptic facilitation of norepinephrine release from sympathetic nerves . We tested this proposition in 19 patients with essential hypertension , evaluating whether the angiotensin receptor blockers ( ARBs ) eprosartan and losartan had identifiable antiadrenergic properties . This was done in a prospect i ve , r and omized , three-way placebo-controlled study of crossover design . Patients were r and omized to 600 mg of eprosartan daily , 50 mg of losartan daily , or placebo . The treatment period was 4 wk , with 2-wk washout periods . Multiunit firing rates in efferent sympathetic nerves distributed to skeletal muscle vasculature ( muscle sympathetic nerve activity , MSNA ) were measured with microneurography , testing whether ARBs inhibit central sympathetic outflow . In parallel , isotope dilution methodology was used to measure whole body norepinephrine spillover to plasma . Mean blood pressure on placebo was 151/98 mmHg , with both ARBs causing reductions of approximately 11 mmHg systolic and 6 mmHg diastolic pressure , placebo corrected . Both MSNA [ 35 + /- 12 bursts/min ( mean + /- SD ) on placebo ] and whole body norepinephrine spillover [ 366 + /- 247 ng/min ] were unchanged by ARB administration , indicating that the ARBs did not material ly inhibit central sympathetic outflow or act presynaptically to reduce norepinephrine release at existing rates of nerve firing . These findings contrast with the easily demonstrable reduction in sympathetic nervous activity produced by antihypertensive drugs of the imidazoline-binding class , which are known to act within the brain to inhibit sympathetic nervous outflow . We conclude that sympathetic nervous inhibition is not a major component of the blood pressure-lowering action of ARBs in essential hypertension Impaired nitric oxide ( NO ) vasodilation ( endothelial dysfunction ) is associated with obesity and thought to be a factor in the development of hypertension . We previously found that NO synthesis inhibition had similar pressor effects in obese hypertensives compared with healthy control during autonomic blockade , suggesting that impaired NO vasodilation is secondary to sympathetic activation . We tested this hypothesis by determining the effect of autonomic blockade ( trimethaphan 4 mg/min IV ) on NO-mediated vasodilation ( increase in forearm blood flow to intrabrachial acetylcholine ) compared with endothelial-independent vasodilation ( intrabrachial sodium nitroprusside ) in obese hypertensive subjects ( 30<body mass index<40 kg/m2 ) . Acetylcholine and sodium nitroprusside were given at equipotent doses ( 10 , 30 , and 50 & mgr;g/min and 1 , 2 , and 3 & mgr;g/min , respectively ) to 14 obese subjects ( 49±3.6 years , 34±1 kg/m2 , 165/94±7/6 mm Hg ) , on separate occasions 1 month apart , r and omly assigned . Autonomic blockade increased basal forearm blood flow ( from 3.9±0.7 to 5.2±1.2 mL/100 mL per minute , P=0.078 ) . As expected , NO-mediated vasodilation was blunted on the intact day compared with NO-independent vasodilation ; forearm blood flow increased from 3.6±0.6 to 10.1±1.1 with the highest dose of nitroprusside , but only from 3.7±0.4 to 7.2±0.8 mL/100 mL per minute with the highest dose of acetylcholine , P<0.05 . In contrast , forearm blood flow responses to acetylcholine were restored by autonomic blockade and were no longer different to nitroprusside ( from 6.2±1.1 to 11.4±1.6 mL/100 mL per minute and from 5.2±0.9 to 12.5±0.9 , respectively , P=0.58 ) . Our results support the concept that sympathetic activation contributes to the impairment in NO-mediated vasodilation seen in obesity-associated hypertension and provides further rationale to explore it as a therapeutic target Renal sympathetic denervation ( RDN ) is under investigation as a treatment option in patients with resistant hypertension ( RH ) . Determinants of arterial compliance may , however , help to predict the BP response to therapy . Aortic distensibility ( AD ) is a well-established parameter of aortic stiffness and can reliably be obtained by CMR . This analysis sought to investigate the effects of RDN on AD and to assess the predictive value of pre-treatment AD for BP changes . We analyzed data of 65 patients with RH included in a multicenter trial . RDN was performed in all participants . A st and ardized CMR protocol was utilized at baseline and at 6-month follow-up . AD was determined as the change in cross-sectional aortic area per unit change in BP . Office BP decreased significantly from 173/92 ± 24/16 mmHg at baseline to 151/85 ± 24/17 mmHg ( p < 0.001 ) 6 months after RDN . Maximum aortic areas increased from 604.7 ± 157.7 to 621.1 ± 157.3 mm2 ( p = 0.011 ) . AD improved significantly by 33 % from 1.52 ± 0.82 to OUTPUT:

This indicates that even in the absence of metabolic abnormalities , overweight and obesity are not innocuous , perhaps because the traditional cardiovascular risk factors are either not present early or remain undetected using routine clinical assessment . This raises the concept that early or sub clinical organ damage assessment s may be better at identifying subjects who are more likely to progress to develop cardiovascular disease .

MS2_dynamic_1_shot94

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Tai Chi , a moving meditation , is examined for its efficacy in post-stressor recovery . Forty-eight male and 48 female Tai Chi practitioners were r and omly assigned to four treatment groups : Tai Chi , brisk walking , mediation and neutral reading . Mental arithmetic and other difficult tests were chosen as mental challenges , and a stressful film was used to produce emotional disturbance . Tai Chi and the other treatments were applied after these stressors . After all treatments , the salivary cortisol level dropped significantly , and the mood states were also improved . In general the stress-reduction effect of Tai Chi characterized moderate physical exercise . Heart rate , blood pressure , and urinary catecholamine changes for Tai Chi were found to be similar to those for walking at a speed of 6 km/hr . Although Tai Chi appeared to be superior to neutral reading in the reduction of state anxiety and the enhancement of vigour , this effect could be partially accounted for by the subjects ' high expectations about gains from Tai Chi . Approaches controlling for expectancy level are recommended for further assessment Objective To determine the effect of Tai Chi on oxidative stress in a population of elderly Mexican subjects . Design It was carried out a quasi-experimental study with a sample of 55 healthy subjects r and omly divided into two age-matched groups : ( i ) a control group with 23 subjects and ( ii ) an experimental group with 32 subjects . The experimental group received daily training in Tai Chi for 50 min . Measurements It was measured before and after 6-month of exercise period : thiobarbituric acid reactive substances ( TBARS ) , total antioxidant status ( TAS ) , superoxide dismutase ( SOD ) , and glutathione peroxidase ( GPx ) . Results It was found that the experimental group exhibited a statistically significant decrease in glucose levels , total cholesterol , low-density lipoprotein cholesterol ( LDLC ) , and systolic blood pressure , as well as an increase in SOD and GPx activity and TAS compared with the control group ( p < 0.05 ) . Conclusions Our findings suggest that the daily practice of Tai Chi is useful for reducing OxS in healthy older adults This study was design ed to determine whether a 6-month Tai Chi exercise program can improve self-reported physical functioning limitations among healthy , physically inactive older individuals . Ninety-four community residents ages 65 to 96 ( M age = 72.8 years , SD = 5.1 ) volunteered to participate in the study . Participants were r and omly assigned to either a 6-month experimental ( Tai Chi ) group ( n = 49 ) , which exercised twice per week for 60 min , or a wait-list control group ( n = 45 ) . A 6-item self-report physical functioning scale , assessing the extent of behavioral dysfunction caused by health problems , was used to evaluate change in physical functioning limitations as a result of Tai Chi intervention . Results indicated that compared to the control group , participants in the Tai Chi group experienced significant improvements in all aspects of physical functioning over the course of the 6-month intervention . Overall , the experimental group had 65 % improvement across all 6 functional status measures ranging from daily activities such as walking and lifting to moderate-vigorous activities such as running . It was concluded that the 6-month Tai Chi exercise program was effective for improving functional status in healthy , physically inactive older adults . A self-paced and self-controlled activity such as Tai Chi has the potential to be an effective , low-cost means of improving functional status in older persons OBJECTIVE To evaluate the effects of two exercise approaches , Tai Chi ( TC ) and computerized balance training ( BT ) , on specified primary outcomes ( biomedical , functional , and psychosocial indicators of frailty ) and secondary outcomes ( occurrence of falls ) . DESIGN The Atlanta FICSIT ( Frailty and Injuries : Cooperative Studies of Intervention Techniques ) , a prospect i ve , r and omized , controlled clinical trial with three arms ( TC , BT , and education [ ED ] . Intervention length was 15 weeks , with primary outcomes measured before and after intervention and at 4-month follow-up . Falls were monitored continuously throughout the study . SETTING Persons aged 70 and older living in the community . PARTICIPANTS A total of 200 participants , 162 women and 38 men ; mean age was 76.2 . MEASUREMENTS Biomedical ( strength , flexibility , cardiovascular endurance , body composition ) , functional ( IADL ) , and psychosocial well-being ( CES-D scale , fear of falling question naire , self-perception of present and future health , mastery index , perceived quality of sleep , and intrusiveness ) variables . RESULTS Grip strength declined in all groups , and lower extremity range of motion showed limited but statistically significant changes . Lowered blood pressure before and after a 12-minute walk was seen following TC participation . Fear of falling responses and intrusiveness responses were reduced after the TC intervention compared with the ED group ( P = .046 and P = .058 , respectively ) . After adjusting for fall risk factors , TC was found to reduce the risk of multiple falls by 47.5 % . CONCLUSIONS A moderate TC intervention can impact favorably on defined biomedical and psychosocial indices of frailty . This intervention can also have favorable effects upon the occurrence of falls . Tai Chi warrants further study as an exercise treatment to improve the health of older people BACKGROUND Patients with Parkinson 's disease have substantially impaired balance , leading to diminished functional ability and an increased risk of falling . Although exercise is routinely encouraged by health care providers , few programs have been proven effective . METHODS We conducted a r and omized , controlled trial to determine whether a tailored tai chi program could improve postural control in patients with idiopathic Parkinson 's disease . We r and omly assigned 195 patients with stage 1 to 4 disease on the Hoehn and Yahr staging scale ( which ranges from 1 to 5 , with higher stages indicating more severe disease ) to one of three groups : tai chi , resistance training , or stretching . The OUTPUT: Due to the limited evidence available currently no conclusions can be drawn as to the effectiveness of tai chi on CVD risk factors . There was some suggestion of beneficial effects of tai chi on CVD risk factors but this was not consistent across all studies . INPUT: Background Patients suffering from Multiple Sclerosis ( MS ) experience a wide array of symptoms , including balance problems , mobility impairment , fatigue and depression . Physical exercise has recently been acknowledged as a treatment option complementary to medication . However , information regarding putative effects of structured exercise programs on neurological symptoms is sparse . Tai Chi , a Chinese martial art incorporating physical exercise and mindfulness training , has been shown to yield health benefits in various neurological groups . It seems particularly suitable for patients with motoric deficits as it challenges coordination and balance . The purpose of the current study was to explore the therapeutic value of structured Tai Chi training for coordination , balance , fatigue and depression in mildly disabled MS patients . Methods A sample of 32 MS patients ( Exp and ed Disability Status Scale , EDSS < 5 ) was examined . A structured Tai Chi course was devised and a Tai Chi group participated in two weekly sessions of 90 minutes duration for six months , while a comparison group received treatment as usual ( TAU ) . Both groups were examined prior to and following the six-months interval with regards to balance and coordination performance as well as measures of fatigue , depression and life satisfaction . Results Following the intervention , the Tai Chi group showed significant , consistent improvements in balance , coordination , and depression , relative to the TAU group ( range of effect-sizes : partial η2 = 0.16 – 0.20 ) . Additionally , life satisfaction improved ( partial η2 = 0.31 ) . Fatigue deteriorated in the comparison group , whereas it remained relatively stable in the Tai Chi group ( partial η2 = 0.24 ) . Conclusions The consistent pattern of results confirms that Tai Chi holds therapeutic potential for MS patients . Further research is needed to determine underlying working mechanisms , and to verify the results in a larger sample and different MS subgroups Background Many breast cancer survivors experience fatigue , mood , and sleep disturbances . Purpose This study aims to compare a meditative movement practice , Qigong/Tai Chi Easy ( QG/TCE ) with sham Qigong ( SQG ) , testing effects of meditation/breath aspects of QG/TCE on breast cancer survivors ’ persistent fatigue and other symptoms . Methods This double-blind , r and omized controlled trial tested 12 weeks of QG/TCE versus SQG on fatigue , depression , and sleep among 87 postmenopausal , fatigued breast cancer survivors , stages 0–III , age 40–75 . Results Fatigue decreased significantly in the QG/TCE group compared to control at post-intervention ( p = 0.005 ) and 3 months follow-up ( p = 0.024 ) , but not depression and sleep quality . Improvement occurred over time for both interventions in depression and sleep quality ( all p < 0.05 ) . Conclusions QG/TCE showed significant improvement over time compared to SQG for fatigue , but not depression or sleep . Both QG/TCE and SQG showed improvement for two prevalent symptoms among breast cancer survivors , depression and sleep dysfunction OBJECTIVE Evaluate effectiveness of the Arthritis Foundation Tai Chi Program for community participants with arthritis . METHODS 343 individuals were r and omized to either the intervention or wait-list control group . Performance and self-reported outcome ( SRO ) measures were assessed at baseline and eight weeks . At one year , SROs only were assessed . Adjusted means were determined using regression models adjusting for covariates , and effect sizes ( ES ) were calculated . RESULTS Average participant age was 66 years , 87 % were female , and 87 % were Caucasian . Among 284 ( 83 % ) participants who returned at eight weeks , balance by reach ( ES = 0.30 ) and helplessness , sleep , and role participation satisfaction ( ES = 0.24 - 0.54 ) improved significantly ; pain , fatigue , and stiffness improvement ( ES = 0.15 - 0.23 ) approached significance . No change was noted in mobility , lower extremity strength , or single-leg stance balance . At one year , improvements in pain , fatigue , stiffness , helplessness , and role participation satisfaction at eight weeks were maintained ; 30 % continued tai chi practice . CONCLUSION Moderate effectiveness of the Arthritis Foundation Tai Chi Program was confirmed Background Cancer-related fatigue ( CRF ) is a common and often long-lasting symptom for many breast cancer survivors . Evidence for its management is scarce . However , the Traditional Chinese Medicine ( TCM ) Shu Gan Jian Pi ( SGJP ) granules is an effective and practical therapy for CRF . Methods / Design We will conduct a multicenter , r and omized , double-blind , placebo-controlled clinical trial to determine whether the SGJP granules can effectively manage CRF . Breast cancer survivors experiencing fatigue within 5 years of primary treatment completion will be enrolled and r and omly assigned to Group S ( SGJP ) or Group P ( placebo ) . The primary outcome measures will include Revised Piper Fatigue Scale score . Outcome measures will be collected at baseline and at weeks 2 , 4 , and 8 . Discussion This study ’s findings may contribute to the development of an effective intervention for CRF.Trial registration Current controlled trials IS RCT N12702489 , 14 August , 2013 Background . Multiple sclerosis ( MS ) is a chronic demyelinating neurological disease . Several studies have reported that complementary and alternative therapies can have positive effects against pain in these patients . Objective . The objective was to investigate the effectiveness of an Ai-Chi aquatic exercise program against pain and other symptoms in MS patients . Methods . In this r and omized controlled trial , 73 MS patients were r and omly assigned to an experimental or control group for a 20-week treatment program . The experimental group underwent 40 sessions of Ai-Chi exercise in swimming pool and the control group 40 sessions of abdominal breathing and contraction-relax OUTPUT:

The results suggest that Tai Chi could be an effective alternative and /or complementary approach to existing therapies for people with fatigue . There is still absence of adverse events data to evaluate the safety of Tai Chi .

MS2_dynamic_1_shot95

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: CONTEXT Physical activity can reduce the risk of hip fractures in older women , although the required type and duration of activity have not been determined . Walking is the most common activity among older adults , and evidence suggests that it can increase femoral bone density and reduce fracture risk . OBJECTIVE To assess the relationship of walking , leisure-time activity , and risk of hip fracture among postmenopausal women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve analysis begun in 1986 with 12 years of follow-up in the Nurses ' Health Study cohort of registered nurses within 11 US states . A total of 61,200 postmenopausal women ( aged 40 - 77 years and 98 % white ) without diagnosis of cancer , heart disease , stroke , or osteoporosis at baseline . MAIN OUTCOME MEASURES Incident hip fracture result ing from low or moderate trauma , analyzed by intensity and duration of leisure-time activity and by time spent walking , sitting , and st and ing , measured at baseline and up date d throughout follow-up . RESULTS From 1986 to 1998 , 415 incident hip fracture cases were identified . After controlling for age , body mass index , use of postmenopausal hormones , smoking , and dietary intakes in proportional hazards models , risk of hip fracture was lowered by 6 % ( 95 % confidence interval [ CI ] , 4%-9 % ; P<.001 ) for each increase of 3 metabolic equivalent (MET)-hours per week of activity ( equivalent to 1 h/wk of walking at an average pace ) . Active women with at least 24 MET-h/wk had a 55 % lower risk of hip fracture ( relative risk [ RR ] , 0.45 ; 95 % CI , 0.32 - 0.63 ) compared with sedentary women with less than 3 MET-h/wk . Even women with a lower risk of hip fracture due to higher body weight experienced a further reduction in risk with higher levels of activity . Risk of hip fracture decreased linearly with increasing level of activity among women not taking postmenopausal hormones ( P<.001 ) , but not among women taking hormones ( P = .24 ) . Among women who did no other exercise , walking for at least 4 h/wk was associated with a 41 % lower risk of hip fracture ( RR , 0.59 ; 95 % CI , 0.37 - 0.94 ) compared with less than 1 h/wk . More time spent st and ing was also independently associated with lower risks . CONCLUSION Moderate levels of activity , including walking , are associated with substantially lower risk of hip fracture in postmenopausal women Background . The effect of physical training on bone mineral density ( BMD ) in women with endometriosis treated with gonadotropin‐releasing hormone ( GnRH ) analogs was studied Summary The purpose of this study was to determine the optimal intensity of exercise necessary to prevent the postmenopausal bone loss on the basis of anaerobic threshold ( AT ) . Thirty-three postmenopausal women were r and omized to control ( group C : n=12 ) or two exercise groups ( group H and group M ) . All women performed a treadmill exercise test , and the AT was measured by expired gas analysis . The exercise regimen consisted mainly of walking at a speed that kept the exercise heart rate above the AT ( group H : n=12 ) or below the AT ( group M : n=9 ) . Exercise was performed for 30 minutes , three times a week for 7 months . The bone mineral density ( BMD ) of the lumbar vertebrae was measured using dual energy X-ray absorptiometry . The BMD level in group C decreased by 1.7±2.7 % , but there was a significant increase of 1.1±2.9 % in group H. In group M there was a decrease of 1.0±3.1 % which did not differ from group C. In group C , serum osteocalcin and urinary hydroxyproline excretion were significantly increased , but no changes were seen in either of the exercise groups . Urinary calcium significantly decreased in the exercise groups . We conclude that short-term ( 7 months ) exercise with intensity above the AT is safe and effective in preventing postmenopausal bone loss Abstract . Several meta-analyses confirm that physical exercise can slow down postmenopausal bone loss , but it is not clear whether physical exercise alone can increase bone mass . Our intent was to evaluate high-impact exercises ( including jumping ) and combined balance and leg-strength training , with and without raloxifene treatment , in three healthy elderly women , age 68–71 years . The 40-week study period consisted of two 17-week exercise periods with a 6-week rest period in between . The jumping exercises were performed both vertically and in different directions . Effects were measured in bone mineral density ( BMD ) , balance , maximal gait speed , and leg extensor strength . BMD ( g/cm2 ) was measured with dual-energy X-ray photon absorptiometry ( DXA ) at the proximal femur , lumbar spine , and total body . After the first exercise period , large losses of trochanteric BMD ( 8.1%–10.8 % ) were seen in all subjects . After both 6 weeks of rest and the second exercise period , which included both exercise and raloxifene , BMD increased in all subjects . During both exercise periods , the balance , gait speed , and leg extensor strength increased in all subjects . The results show that this kind of high-impact exercise had limited effects on BMD , but had large positive effects on balance , gait speed , and leg extensor strength . In conclusion , high-impact exercise in elderly women improves their fall risk factors , but , at least without raloxifene treatment , the trochanteric fracture risk might even increase because of reduction in the regional bone mass 1 . This study examined the influence of brisk walking on skeletal status in post OUTPUT: We conclude that regular walking has no significant effect on preservation of BMD at the spine in postmenopausal women , whilst significant positive effects at femoral neck are evident . Other forms of exercise that provide greater targeted skeletal loading may be required to preserve bone mineral density in this population INPUT: CONTEXT Physical activity can reduce the risk of hip fractures in older women , although the required type and duration of activity have not been determined . Walking is the most common activity among older adults , and evidence suggests that it can increase femoral bone density and reduce fracture risk . OBJECTIVE To assess the relationship of walking , leisure-time activity , and risk of hip fracture among postmenopausal women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve analysis begun in 1986 with 12 years of follow-up in the Nurses ' Health Study cohort of registered nurses within 11 US states . A total of 61,200 postmenopausal women ( aged 40 - 77 years and 98 % white ) without diagnosis of cancer , heart disease , stroke , or osteoporosis at baseline . MAIN OUTCOME MEASURES Incident hip fracture result ing from low or moderate trauma , analyzed by intensity and duration of leisure-time activity and by time spent walking , sitting , and st and ing , measured at baseline and up date d throughout follow-up . RESULTS From 1986 to 1998 , 415 incident hip fracture cases were identified . After controlling for age , body mass index , use of postmenopausal hormones , smoking , and dietary intakes in proportional hazards models , risk of hip fracture was lowered by 6 % ( 95 % confidence interval [ CI ] , 4%-9 % ; P<.001 ) for each increase of 3 metabolic equivalent (MET)-hours per week of activity ( equivalent to 1 h/wk of walking at an average pace ) . Active women with at least 24 MET-h/wk had a 55 % lower risk of hip fracture ( relative risk [ RR ] , 0.45 ; 95 % CI , 0.32 - 0.63 ) compared with sedentary women with less than 3 MET-h/wk . Even women with a lower risk of hip fracture due to higher body weight experienced a further reduction in risk with higher levels of activity . Risk of hip fracture decreased linearly with increasing level of activity among women not taking postmenopausal hormones ( P<.001 ) , but not among women taking hormones ( P = .24 ) . Among women who did no other exercise , walking for at least 4 h/wk was associated with a 41 % lower risk of hip fracture ( RR , 0.59 ; 95 % CI , 0.37 - 0.94 ) compared with less than 1 h/wk . More time spent st and ing was also independently associated with lower risks . CONCLUSION Moderate levels of activity , including walking , are associated with substantially lower risk of hip fracture in postmenopausal women Background : Existing data suggest that physical activity reduces colon cancer risk , but the association is not consistently observed in women . One potential explanation for this inconsistency is that hormone therapy , which is associated with lower colon cancer risk , acts as a modifier of the physical activity/colon cancer relationship . Methods : Participants in the California Teachers Study ( N = 120,147 ) , a prospect i ve cohort of female teachers and administrators residing in California , ages 22 to 84 years at baseline and with no prior history of colon cancer were eligible for study . Between 1996 and 2002 , 395 patients were diagnosed with invasive colon cancer . The relative risks ( RR ) associated with lifetime ( high school through age 54 years or current age ) and recent ( past 3 years ) strenuous and moderate recreational physical activity were estimated using Cox proportional hazards regression models . Results : Combined lifetime moderate and strenuous recreational physical activity was only modestly associated with colon cancer risk in the cohort [ ≥4 versus ≤0.5 h/wk/y : RR , 0.75 ; 95 % confidence interval , 0.57 - 1.00 ; Ptrend = 0.23 ] . Lifetime physical activity reduced colon cancer risk among postmenopausal women who had never taken hormone therapy ( ≥4 versus ≤0.5 h/wk/y : RR , 0.51 ; 95 % confidence interval , 0.31 - 0.85 ; Ptrend = 0.02 ) . Postmenopausal women with histories of hormone therapy use had lower colon cancer risk , but their risk was not associated with physical activity . The likelihood ratio test for interaction between hormone use and lifetime moderate plus strenuous physical activity was of borderline statistical significance ( P = 0.05 ) . We observed no effect modification by age , body mass index , smoking status , menopausal status , or folate intake . Conclusions : Lifetime recreational physical activity may protect against colon cancer among postmenopausal women who have never used hormone therapy . Among hormone therapy users , who have lower risk of colon cancer , recreational physical activity does not seem to provide any additional benefit . With declining rates of hormone therapy use , physical activity offers one possible means for reducing women 's colon cancer risk . ( Cancer Epidemiol Biomarkers Prev 2007;16(3):517–25 Background Lifestyle is a well-established risk factor for colorectal cancer ( CRC ) and is also found to be associated with occurrence of adenomas . In the present study we evaluated risk factors for both low-risk adenomas and advanced neoplasia in asymptomatic individuals using a single-paged question naire . Aim ing to see if the question naire was a useful tool in picking up high-risk individuals . Methods A cross-sectional study was carried out within a r and omised controlled colorectal cancer screening trial ( n = 6961 ) . The population comprised men and women born between 1946 and 1950 . Before screening in year 2001 they were asked to fill in a question naire about their present lifestyle . Cases were categorised according to the most OUTPUT:

Overall , the current literature supports clearly the dose-response relationship between physical activity and the seven chronic conditions identified . Moreover , higher levels of physical activity reduce the risk for premature all-cause mortality . The current Canadian guidelines appear to be appropriate to reduce the risk for the seven chronic conditions identified above and all-cause mortality

MS2_dynamic_1_shot96

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: OBJECTIVE The aim of the present prospect i ve clinical study was to compare patient-reported outcomes for maxillary conventional dentures and maxillary implant-supported dentures . MATERIAL AND METHODS Twenty-one patients ( 6 women and 15 men ) being edentulous in the maxilla and encountering problems with their existing dentures were included . Twelve patients ( 4 women and 8 men ) received a new set of conventional dentures , due to insufficient dentures . In nine patients ( 2 women and 7 men ) , the existing dentures were adjusted by means of relining or rebasing . All patients received implant-supported dentures on two retentive anchors . In total , 42 implants were inserted in the anterior maxilla . The participants rated their satisfaction on their existing conventional dentures , 2 months after insertion of new conventional dentures and 2 months after insertion of implant-supported dentures . Thereby , patients responded to question naires capturing the oral health impact profile ( OHIP ) using visual analog scales . Seven domains ( functional limitation , physical pain , psychological discomfort , physical , psychological and social disability and h and icap ) were assessed . Higher scores implied poorer patient satisfaction . In addition , the question naire involved the evaluation of cleaning ability , general satisfaction , speech , comfort , esthetics , stability , and chewing ability . Higher scores implied higher patient satisfaction . RESULTS Patient satisfaction significantly increased for implant-supported dentures compared with old dentures in all seven OHIP subgroups , as well as for cleaning ability , general satisfaction , ability to speak , comfort , esthetics , and stability ( P < 0.05 ) . The comparison of new conventional dentures and implant-supported dentures revealed a statistically significantly increased satisfaction for functional limitation ( difference of 33.2 mm ) , psychological discomfort ( difference of 36.7 mm ) , physical disability ( difference of 36.3 mm ) , and social disability ( difference of 23.5 mm ) , ( P < 0.05 ) . Additionally , general satisfaction , chewing ability , speech , and stability significantly improved in implant-supported dentures ( P < 0.05 ) . CONCLUSIONS Within the limits of this study , maxillary dentures retained by two implants provided some significant short-term improvements over conventional dentures in oral- and health-related quality of life PURPOSE This study evaluated the effects of different implant-based prostheses on swallowing threshold , dietary intake , and oral health-related quality of life ( OHRQoL ) . MATERIAL S AND METHODS This prospect i ve paired controlled clinical trial followed partially edentulous subjects , who sequentially used implant-supported removable partial dentures and implant-supported fixed partial dentures ( IFPDs ) . Swallowing threshold was assessed by counting the masticatory cycles and median particle size ( X₅₀ ) calculation . Nutritional intake was verified by a 3-day food record . OHRQoL was measured with the Oral Health Impact Profile ( OHIP-49 ) . Data were evaluated with repeated- measures analysis of variance . RESULTS Twelve subjects ( mean age 62.6 ± 7.8 years ; range , 55 to 87 ) took part in the study . IFPD treatment significantly reduced X₅₀ values and the number of chewing cycles . Higher intake of fiber , calcium , and iron and lower consumption of cholesterol-rich food were observed after IFPD use . OHIP summary score and OHIP physical pain domain were lower with the IFPD . CONCLUSION IFPD use leads to more efficient mastication and improves dietary intake and OHRQoL. This information will guide dentists to better clinical management of partially edentulous patients BACKGROUND A major reason for the success of modern dental implant systems has been the development of implant design s that enhance direct bone-implant interface . Surface roughness has been a factor in this success and different systems have utilized very different implant surface roughness . The major purpose of this study was to evaluate 2 similar implants with different surface roughness characteristics . METHODS Two similarly design ed , screw-type , commercially pure titanium implants , one dual acid-etched ( DAE ) and the other machined-surfaced ( MS ) , were compared in this prospect i ve , r and omized-controlled , multi-center study , in which a total of 97 patients were enrolled at a private dental practice or a university dental clinic . Both implant types were placed in each patient using a 2-stage approach with a conventional 4- to 6-month healing period . Implants supported fixed prostheses , hybrid prostheses , and overdentures as dictated by the individual patient 's need . All of the cases were followed using clinical and radiographic examinations . Criteria of success were the absence of peri-implant radiolucency , mobility , and persistent signs or symptoms of pain or infection . RESULTS Of the 432 implants ( 247 dual acid-etched , 185 machined-surfaced ) , 36 implants ( 12 dual acid-etched and 24 machined-surfaced ) have failed . The pre-loading integration success rate of the dual acid-etched implants ( 95.0 % ) was statistically higher ( P < 0.01 ) than the success rate of the machined-surfaced implants ( 86.7 % ) . At 36 months , the cumulative success rates ( CSR ) are 95.0 % for the dual acid-etched implants and 86.7 % for the machined-surfaced implants . CONCLUSIONS The difference in success rates is most likely attributed to the acid-etched surface characteristics . The greatest performance difference is observed in the conditions of poor quality or soft bone where the 3-year post-loading CSR are 96.8 % ( dual acid-etched ) and 84.8 % ( machined-surfaced ) PURPOSE The purpose of this study was to compare elderly patients ' satisfaction and oral health-related quality of life with m and ibular two-implant overdentures and conventional dentures . MATERIAL S AND METHODS Sixty ed OUTPUT: Within its limitations , this review suggests that replacement implants have moderate SR . INPUT: INTRODUCTION Up-to- date studies comparing endodontic treatment versus implant-supported prosthesis have shown similar clinical outcome and survival rates . However , no data are available comparing both treatment modalities based on the patient 's perception of quality of life . This study was design ed to qualitatively describe and compare the quality of life of patients with restored , single endodontically treated teeth versus patients with single implant-supported fixed prostheses . METHODS Forty-eight patients agreed to participate in the study ( n = 24 from each treatment modality ) . Of those , 37 actually participated in the study : 17 were endodontically treated and 20 had an implant-supported prosthesis . Patients in each of the two groups were r and omly selected from the Graduate Endodontics and Graduate Periodontics Departments , respectively . Six focus group discussion s ( n = 3 per treatment group ) were held and audio-recorded for subsequent thematic analysis . Data were analyzed to identify common themes within each category and compared to assess any differences in quality of life between the two treatments . Additionally , a quality of life survey , the shortened version of the Oral Health Impact Profile ( OHIP-14 ) , was given before the discussion group and the responses analyzed . RESULTS The results obtained from this study show similar overall OHIP scores and show a high rate of satisfaction with both treatment modalities . Content analysis of the discussion groups revealed several themes and subthemes . The major themes were importance of overall health , financial implication s of the treatments , perception of the treatments and its outcomes , time since treatment , and follow-up dental visits . CONCLUSIONS The results help identify patients ' perception and concerns with each treatment modality and assist the clinician and patient in the selection of an optimal treatment for their given situation . In addition to the prognosis and outcomes , clinicians should consider patients ' perceptions and preferences as well as the influence each therapy may have on their quality of life , both short- and long-term . Overall , all the participants in this study were pleased with the treatment received and expressed a clear message to save their natural dentition whenever possible INTRODUCTION : Pulpectomy of primary teeth is commonly carried out with h and files and broaches ; a tricky and time consuming procedure . The purpose of this in vitro study was to compare the cleaning efficacy and time taken for instrumentation of deciduous molars using h and K-files and Flex Master rotary system . MATERIAL S AND METHODS : In this study , 68 canals of 23 extracted primary molars with at least two third intact roots and 7 - 12 mm length were selected . After preparing an access cavity , K-file size # 15 was introduced into the root canal and India ink was injected with an insulin syringe . Sixty sample s were r and omly divided in to experimental groups in group I ( n=30 ) , root canals were prepared with h and K-files ; in group II ( n=30 ) , rotary Flex Master files were used for instrumentation , and in group III 8 remained sample s were considered as negative controls . After clearing and root sectioning , the removal of India ink from cervical , middle , and apical thirds was scored . Data was analyzed using student 's T-test and Mann-Whitney U test . RESULTS : There was no significant difference between experimental groups cleaning efficacy at the cervical , middle and apical root canal thirds . Only the coronal third scored higher in the h and instrumented group ( P<0.001 ) . Instrumentation with Flex Master rotary files was significantly less time consuming ( P<0.001 ) . CONCLUSION : Although there was no difference in cleanliness efficacy at the apical and middle thirds , the coronal third was more effectively cleaned with h and files . Predictably , time efficiency was a significant advantage with rotary technique AIM To compare in vitro intracanal bacterial reduction using nickel-titanium rotary instruments with and without apical enlargement . METHODOLOGY Thirty-eight palatal roots of maxillary molar teeth , with mature apices were subdivided according to lengths and then r and omly assigned to two experimental and one control groups . The roots were sterilized and then reinfected with Enterococcus faecalis , which served as a bacteriological marker . All roots in the experimental groups were prepared in a step-down sequence with engine-driven GT rotary files at 350 rpm . In experimental group A ( n = 16 ) additional apical enlargement to ISO size 35 was performed . In group B ( n = 16 ) a serial step-back technique was followed with no apical enlargement . This was combined in groups A and B with irrigation with NaOCl and EDTA . In the control group ( group C , n = 6 ) irrigation only was carried out , with no mechanical preparation . Sample s were then taken from the root canals to determine the numbers of remaining bacteria . RESULTS In groups A and B , 15 ( 94 % ) and 13 ( 81 % ) specimens were rendered bacteria-free , respectively . In the control group C none of the specimens were bacteria-free . There was a significant difference ( P < 0.001 ) in the antibacterial effects of experimental and control regimens . There was , however , no significant difference ( P = 0.276 ) between the preparation methods used in the experimental groups . CONCLUSIONS There was no significant difference in intracanal bacterial reduction when Ni-Ti GT rotary preparation with NaOCl and EDTA irrigation was used with or without apical enlargement preparation technique . It may therefore not be necessary to remove dentine in the apical part of the root canal when a suitable coronal taper is achieved to allow satisfactory irrigation of the root canal system with antimicrobial agents OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assess OUTPUT:

Conclusions The results of this systematic review suggested that NiTi rotary instruments were associated with lower canal transportation and apical extrusion when compared to SST h and files , whereas both groups had similar outcomes in terms of success of therapy , amount of residual bacteria , and cleansing ability after treatment .

MS2_dynamic_1_shot97

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: The Infant Health and Development Program is a r and omized clinical trial to test the efficacy of educational and family support services and pediatric follow-up , offered during the first 3 years of life , in reducing the incidence of developmental delay in low birth weight preterm infants at eight clinical sites ( N = 985 ) . It was hypothesized that larger intervention effects would be found for the domains in which low birth weight preterm infants are known to have problems , specifically visual-motor and spatial skills and receptive language skills . These analyses explore the effects of the Infant Health and Development Program on different domains of cognitive functioning . Cognitive domains are identified by means of factor analysis of the intelligence tests used at 12 , 24 , and 36 months ( Bayley Scales of Infant Development ( including the Mental and Motor scales ) at 12 and 24 months ; the Stanford-Binet , Peabody Picture Vocabulary Test , and Beery Test of Visual Motor Intergration at 36 months ) . Our results reveal that , although intervention benefits accrue across cognitive domains at 24 and 36 months , gains are most pronounced for receptive language and visual-motor and spatial skills At a corrected age of 3 months , 80 low birth-weight infants were assigned to normal or at-risk groups on the basis of a neurodevelopmental assessment scale . Both groups were further divided into intervention and non-intervention sub-groups ( 20 infants in each ) . Intervention consisted of monthly hospital-based neurodevelopmental therapy in addition to a home exercise programme . Infants were re-assessed by a physiotherapist at 6 , 9 , and 12 months , and were tested at 12 months by an independent psychologist blinded for infant group . Mean birthweight and gestational age were similar for normal and at-risk groups . At-risk infants had higher mean neurodevelopmental scores throughout the study period and lower 1-year development quotients ( DQ ) than normals . In neither normal nor at-risk groups did neurodevelopmental therapy alter the pattern of development or the outcome OBJECTIVE To determine whether the Infant Behavioral Assessment and Intervention Program ( IBAIP ) , design ed to support and enhance infants ' self-regulatory competence , improved developmental and neurobehavioral outcomes in very low birth weight ( VLBW ) infants . STUDY DESIGN We r and omized 86 infants to 1 intervention before discharge and to 6 to 8 home interventions until 6 months corrected age , and 90 control infants received st and ard care . Developmental and behavioral outcomes were evaluated at 6 months corrected age with the Bayley Scales of Infant Development-II ( BSID-II ) . Neurobehavioral functioning was evaluated with the Infant Behavioral Assessment ( IBA ) at baseline and at 6 months corrected age . RESULTS Despite r and omization , some differences in neonatal characteristics were found between the intervention and control infants . After adjustment , intervention effects of 7.2 points ( + /- st and ard error 3.1 ) on the Mental Developmental Index and 6.4 + /- 2.4 points on the Psychomotor Developmental Index favored the intervention infants . The Behavioral Rating Scale of the BSID-II ( P = .000 ) and the IBA ( more approach [ P = .003 ] and less stress [ P = .001 ] over time ) also favored the intervention infants . CONCLUSIONS The IBAIP improved the mental , motor , and behavioral outcomes of VLBW infants at 6 months corrected age Aims : To test the effectiveness of a home based developmental education intervention in improving outcome at 5 years for very preterm infants . Methods : The Avon Premature Infant Project ( APIP ) is a r and omised controlled trial in which the parents of 284 babies born <33 weeks gestational age received a developmental education programme , a social support intervention , or st and ard care . A term reference population was also recruited . This study reports outcomes at 5 years ( mean age 58 months 15 days ) for 187 ( 66 % ) of these children without disability . Outcomes were assessed using the British Ability Scales II for cognitive development , the Movement ABC for motor impairment , and the Child Behavior Checklist for behavioural problems . Results : Preterm infants showed poorer cognitive performance than their term peers . Mean ( SD ) general conceptual ability ( GCA ) scores were : Portage 99.2 ( 15.7 ) ; parent adviser 100.3 ( 14.8 ) ; preterm control 101.1 ( 15.0 ) ; term reference 107.2 ( 13.4 ) . There were no significant differences between preterm groups in GCA scores indicating no effect of either intervention . Similarly , there was no significant effect of intervention on behavioural or motor outcomes . Further analyses , in which outcome data were adjusted for social factors , did not reveal any differences between the three preterm groups or by subgroups classified by a range of perinatal variables . Conclusion : The small advantage shown at 2 years of age is no longer detectable at 5 years . These results question the effectiveness of early intervention in enhancing cognitive , behavioural , and motor function at 5 years OBJECTIVE . To assess whether improvements in cognitive and behavioral development seen in preschool educational programs persist , we compared those in a multisite r and omized trial of such a program over the first 3 years of life ( INT ) to those with follow-up only ( FUO ) at 18 months of age . METHODS . This was a prospect i ve follow-up of the Infant Health and Development Program at 8 sites heterogeneous for sociodemographic characteristics . Originally 985 children were r and omized to the INT ( n = 377 ) or FUO ( n = 608 ) groups within 2 birth weight strata : heavier low birth weight ( HLBW ; 2001–2499 g ) and lighter low birth weight ( LLBW ; ≤2 OUTPUT: Early intervention had little effect on motor outcome at infant or school age , and there was no study reporting motor outcome at preschool age . INTERPRETATION Current evidence suggests that the benefits of developmental intervention postdischarge are restricted to short-term gains in cognitive outcome INPUT: OBJECTIVES Although most infants born prematurely do not have major developmental problems , those with perinatal medical problems and lengthy stays in the neonatal intensive care unit are at risk for sensory modulation problems and developmental sequelae . This study compared sensory responsiveness in preterm and full-term infants and examined the relationship of sensory responsiveness to temperament and developmental function . METHOD Caregivers of infants with ( n = 45 ) and without ( n = 22 ) prematurity were asked to complete the Sensory Rating Scale . The preterm infants were also evaluated with the Bayley Scales of Infant Development , Second Edition ( BSID-II ) . RESULTS The preterm infants exhibited more frequent behaviors indicating tactile defensiveness and difficult temperament than did the full-term infants . When specific items were examined , the preterm infants displayed sensory-seeking behaviors and high activity levels . As measured by caregivers ' report , sensory responsiveness was significantly related to temperament . It was not related to BSID-II Mental and Psychomotor scale scores . CONCLUSION This study supports the findings of others that preterm infants have mild problems in sensory responsiveness and temperament . Correlational results do not support a definitive relationship between parents ' reports of their infants ' sensory responsiveness and developmental function OBJECTIVE To evaluate the effects of the Infant Behavioral Assessment and Intervention Program ( © ) ( IBAIP ) in very low birth weight infants on sensory processing and daily activities at preschool age . STUDY DESIGN Follow-up of children included in a r and omized controlled trial . Eighty-six infants were enrolled in post-discharge IBAIP until 6 months corrected age , and 90 infants received st and ard care . At 3.5 years of age , the Sensory Profile-Dutch version ( SP-NL ) and Pediatric Evaluation of Disability Inventory-Dutch version ( PEDI-NL ) were administered . For comparison , parents of 41 term-born children also completed the SP-NL . RESULTS Seventy-six children ( 88 % ) in the IBAIP group and 75 children ( 83 % ) children in the control group were examined at 44 months corrected age . After adjustment for pre-r and omization differences in perinatal characteristics , the IBAIP group outperformed the control group significantly on SP-NL domains of oral sensory processing and sensory processing related to endurance/tone and PEDI-NL domains of mobility . The control group only scored significantly lower than the term group on the SP-NL domain endurance/tone . The very low birth weight groups performed significantly below the PEDI-NL 's norm . CONCLUSION In line with the positive developmental effects of the IBAIP until 24 months corrected age , independency in mobility in daily activities was improved at 3.5 years Abstract Alterations in neural activity due to pain and injury in early development may produce long‐term effects on sensory processing and future responses to pain . To investigate persistent alterations in sensory perception , we performed quantitative sensory testing ( QST ) in extremely preterm ( EP ) children ( n = 43 ) recruited from the UK EPICure cohort ( born less than 26 weeks gestation in 1995 ) and in age and sex matched term‐born controls ( TC ; n = 44 ) . EP children had a generalized decreased sensitivity to all thermal modalities , but no difference in mechanical sensitivity at the thenar eminence . EP children who also required neonatal surgery had more marked thermal hypoalgesia , but did not differ from non‐surgical EP children in the measures of neonatal brain injury or current cognitive ability . Adjacent to neonatal thoracotomy scars there was a localized decrease in both thermal and mechanical sensitivity that differed from EP children with scars relating to less invasive procedural interventions or from those without scars . No relationship was found between sensory perception thresholds and current pain experience or pain coping styles in EP or TC children . Neonatal care and surgery in EP children are associated with persistent modality‐specific changes in sensory processing . Decreases in mechanical and thermal sensitivity adjacent to scars may be related to localized tissue injury , whereas generalized decreases in thermal sensitivity but not in mechanical sensitivity suggest central ly mediated alterations in the modulation of C‐fibre nociceptor pathways , which may impact on responses to future pain or surgery Although many perinatal factors have been linked to adverse neurodevelopmental outcomes in very premature infants , much of the variation in outcome remains unexplained . The impact on brain development of 1 potential factor , exposure to stressors in the neonatal intensive care unit , has not yet been studied in a systematic , prospect i ve manner OBJECTIVE To investigate the effects of early experience on brain function and structure . METHODS A r and omized clinical trial tested the neurodevelopmental effectiveness of the Newborn Individualized Developmental Care and Assessment Program ( NIDCAP ) . Thirty preterm infants , 28 to 33 weeks ' gestational age ( GA ) at birth and free of known developmental risk factors , participated in the trial . NIDCAP was initiated within 72 hours of intensive care unit admission and continued to the age of 2 weeks , corrected for prematurity . Control ( 14 ) and experimental ( 16 ) infants were assessed at 2 weeks ' and 9 months ' corrected age on health status , growth , and neurobehavior , and at 2 weeks ' corrected age additionally on electroencephalogram spectral coherence , magnetic resonance diffusion tensor imaging , and measurements of transverse relaxation time . RESULTS The groups were medically and demographically comparable before as well as after the treatment . However , the experimental group showed significantly better neurobehavioral functioning , increased coherence between frontal and a broad spectrum of mainly occipital brain regions , and higher relative anisotropy in left internal capsule , with a trend for right internal capsule and frontal white matter . Transverse relaxation time showed no difference . Behavioral function was improved also at 9 months ' corrected age . The relationship among the 3 neurodevelopmental domains was significant . The OUTPUT:

Results of this review support the presence of sensory modulation problems in preterm children . Sensory modulation problems may play a key role in underst and ing neurocognitive and behavioral sequelae in preterm children . Some support is found for a dose-response relationship between both white matter brain injury and length of NICU stay and sensory modulation problems

MS2_dynamic_1_shot98

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: To address the epidemic of hypertension in blacks born and living in sub-Saharan Africa , we compared in a r and omised clinical trial ( NCT01030458 ) single-pill combinations of old and new antihypertensive drugs in patients ( 30–69 years ) with uncomplicated hypertension ( 140–179/90–109 mm Hg ) . After ⩾4 weeks off treatment , 183 of 294 screened patients were assigned to once daily bisoprolol/hydrochlorothiazide 5/6.25 mg ( n=89 ; R ) or amlodipine/valsartan 5/160 mg ( n=94 ; E ) and followed up for 6 months . To control blood pressure ( < 140/<90 mm Hg ) , bisoprolol and amlodipine could be doubled ( 10 mg per day ) and α-methyldopa ( 0.5–2 g per day ) added . Sitting blood pressure fell by 19.5/12.0 mm Hg in R patients and by 24.8/13.2 mm Hg in E patients and heart rate decreased by 9.7 beats per minute in R patients with no change in E patients ( –0.2 beats per minute ) . The between-group differences ( R minus E ) were 5.2 mm Hg ( P<0.0001 ) systolic , 1.3 mm Hg ( P=0.12 ) diastolic , and 9.6 beats per minute ( P<0.0001 ) . In 57 R and 67 E patients with data available at all visits , these estimates were 5.5 mm Hg ( P<0.0001 ) systolic , 1.8 mm Hg ( P=0.07 ) diastolic and 9.8 beats per minute ( P<0.0001 ) . In R compared with E patients , 45 vs 37 % ( P=0.13 ) proceeded to the higher dose of r and omised treatment and 33 vs 9 % ( P<0.0001 ) had α-methyldopa added . There were no between-group differences in symptoms except for ankle oedema in E patients ( P=0.012 ) . In conclusion , new compared with old drugs lowered systolic blood pressure more and therefore controlled hypertension better in native African black patients Background The efficacy of angiotensin-converting enzyme ( ACE ) inhibitors in decreasing blood pressure in African patients is controversial . Objective We examined the ambulatory blood pressure ( ABP ) response to a diuretic and an ACE inhibitor in hypertensive patients of East African descent and evaluated the individual characteristics that determined treatment efficacy . Design A single-blind r and omized AB/BA crossover design . Setting Hypertensive families of East African descent from the general population in the Seychelles . Participants Fifty-two ( 29 men and 23 women ) out of 62 eligible hypertensive patients were included . Main outcome measures ABP response to 20 mg lisinopril ( LIS ) daily and 25 mg hydrochlorothiazide ( HCT ) daily given for a 4-week period . Results The daytime systolic/diastolic ABP response to HCT was 4.9 [ 95 % confidence interval ( CI ) 1.2–8.6]/3.6 ( 1.0–6.2 ) mmHg for men and 12.9 (9.2–16.6)/6.3 ( 3.7–8.8 ) mmHg for women . With LIS the response was 18.8 (15.0–22.5)/14.6 ( 12.0–17.1 ) mmHg for men and 12.4 (8.7–16.2)/7.7 ( 5.1–10.2 ) mmHg for women . The night-time systolic/diastolic response to HCT was 5.0 (0.6–9.4)/2.7 [ (−0.4)–5.7 ] mmHg for men and 11.5 (7.1–16.0)/5.7 ( 2.6–8.8 ) mmHg for women , and to LIS was 18.7 (14.2–22.1)/15.4 ( 12.4–18.5 ) mmHg for men and 3.5 [(−1.0)–7.9]/2.3 [ (−0.8)–5.4 ] mmHg for women . Linear regression analyses showed that gender is an independent predictor of the ABP responses to HCT and to LIS . Conclusions Hypertensive patients of African descent responded better to LIS than to HCT . Men responded better to LIS than to HCT and women responded similarly to both drugs Objective : To investigate HIV , its treatment , and hypertension as stroke risk factors in Malawian adults . Methods : We performed a case-control study of 222 adults with acute stroke , confirmed by MRI in 86 % , and 503 population controls , frequency-matched for age , sex , and place of residence , using Global Positioning System for r and om selection . Multivariate logistic regression models were used for case-control comparisons . Results : HIV infection ( population attributable fraction [ PAF ] 15 % ) and hypertension ( PAF 46 % ) were strongly linked to stroke . HIV was the predominant risk factor for young stroke ( ≤45 years ) , with a prevalence of 67 % and an adjusted odds ratio ( aOR ) ( 95 % confidence interval ) of 5.57 ( 2.43–12.8 ) ( PAF 42 % ) . There was an increased risk of a stroke in patients with untreated HIV infection ( aOR 4.48 [ 2.44–8.24 ] , p < 0. OUTPUT: Fewer studies assessing combination therapy were available , but there was a trend towards superiority for CCBs plus ACE inhibitors or diuretics compared to other combinations . Evidence broadly supports current guidelines and provides a clear rationale for promoting CCBs as first-line agents and early initiation of combination therapy . INPUT: Recent studies have suggested a differential influence of mean pressure and pulse pressure on myocardial infa rct ion and stroke , and differences among the major drugs in their efficacy at preventing these individual endpoints . We hypothesized that antihypertensive drugs have differing influences upon the pulse wave even when their effects on blood pressure are the same . We studied 30 untreated hypertensive patients , aged 28 - 55 years , who were rotated through six 6-week periods of daily treatment with amlodipine 5 mg , doxazosin 4 mg , lisinopril 10 mg , bisoprolol 5 mg , bendrofluazide 2.5 mg or placebo . The best drug was repeated at the end of the rotation . Blood pressure readings and radial pulse tonometry ( by Sphygmocor ) were performed at each visit , and blood was taken for measurement of levels of atrial natriuretic peptide and brain natriuretic peptide ( BNP ) . The Sphygmocor derivation of the central aortic pulse wave was used to measure time for transmission of the reflected wave ( T(R ) ) and the augmentation index ( AI ) , which is the proportional increase in systolic pressure due to the reflected wave . There was a dissociation between the effects of the drugs on blood pressure and pulse wave analysis . Bisoprolol caused the greatest falls in blood pressure and T(R ) , but was the only drug to increase AI . This paradoxical response to bisoprolol was associated with a 3-fold increase in plasma BNP levels . There was a smaller elevation of BNP in women compared with men , as described previously , and this elevation also was associated with significantly higher values of AI . Other drugs reduced AI , and this was associated with a significant decrease in BNP by amlodipine . In conclusion , antihypertensive drugs differ in their short-term effects on augmentation of the systolic pulse wave and secretion of BNP from the heart , regarded as a sensitive measure of strain on cardiomyocytes . These differences may help to explain cause-specific differences in outcome in recent trials The 24‐h blood pressure control of bisoprolol , a new beta1‐selective , beta‐blocking agent , was studied in 240 mild to moderate hypertensive patients in this 4‐week , r and omized , double‐blind , placebo‐controlled trial . A once‐daily dosing schedule was evaluated by comparing bisoprolol 's antihypertensive effectiveness and safety at 24 h postdose and 3 h postdose , the latter time intended to correspond to peak effectiveness . Results from this trial demonstrated the antihypertensive effectiveness of once‐daily bisoprolol at doses ranging from 5‐20 mg . Mean reductions from baseline diastolic blood pressure , measured 24 h postdose , were 6.3,8.8 , and 10.1 mmHg for patients receiving bisoprolol 5 , 10 , and 20 mg , respectively , compared with 1.6 mmHg for placebo‐treated patients ( p < 0.01 ) ; mean reductions from baseline systolic blood pressure for the bisoprolol groups were 8.6 , 8.6 , and 10.9 mmHg , respectively , versus 3.3 mmHg for placebo ( p≤0.01 ) ; and mean reductions from baseline heart rate for the bisoprolol groups were 5.1,7.1 , and 10.2 beats/min , respectively , compared with a 0.9 beats/min increase in heart rate for the placebo group ( p < 0.01 ) . The response rates for bisoprolol‐treated patients ranged from 47 to 70 % compared with 18 % for patients on placebo ( p < 0.01 ) . Antihypertensive effects were dose‐related and sustained over the 24‐h dosing interval . Near maximal antihypertensive effects were achieved within 1 week of initiation of therapy with bisoprolol and were sustained over the course of the trial Summary Carvedilol 12.5 , 25 and 50 mg was administered once daily for 4 weeks to patients with mild to moderate hypertension . The purpose of the study was to investigate the antihypertensive action of carvedilol when administered once daily and to investigate the pharmacokinetics of carvedilol in patients with mild to moderate hypertension . Measurable decreases in blood pressure ( BP ) occurred within 1 hour after the first dose . Peak decreases in supine diastolic blood pressure ( DBP ) were 9.0 ± 6.8 , 15.5 ± 6.7 , 14.7 ± 10.6 and 22.5 ± 7.6 mm Hg ( ± SD ) for the placebo , 12.5 , 25 and 50 mg carvedilol groups , respectively , and occurred between 3 and 7 hours after the dose . Administration of carvedilol once daily for 4 weeks kept supine DBP below baseline levels for 24 hours . Trough supine DBP after 4 weeks of treatment were 0.6 ± 6.5 , 7.3 ± 7.9 , 8.8 ± 7.4 and 12.1 ± 3.8 mm Hg ( ± SD ) below baseline . Serum levels of carvedilol were proportional to the dose . Peak serum levels were 39 ± 27 , 75 ± 38 and 161 ± 131 μ/L for carvedilol 12.5 , 25 and 50 mg . The kinetics of carvedilol did not change with repeated administration . Carvedilol was well tolerated ; 2 patients experienced dizziness associated with postural hypotension after administration of the 50 mg dose . Carvedilol 12.5 , 25 and 50 mg effectively reduced BP for 24 hours when administered once daily OBJECTIVES To investigate prospect ively the OUTPUT:

SBP-lowering effects were significantly increased for bisoprolol compared with placebo . In conclusion , current evidence does not support carvedilol or bisoprolol as first-line therapy for adult hypertension without compelling indications

MS2_dynamic_1_shot99

***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** INPUT: Generalized anxiety disorder ( GAD ) is a chronic anxiety disorder , associated with comorbidity and impairment in quality of life , for which improved psychosocial treatments are needed . GAD is also associated with reactivity to and avoidance of internal experiences . The current study examined the efficacy of an acceptance-based behavioral therapy aim ed at increasing acceptance of internal experiences and encouraging action in valued domains for GAD . Clients were r and omly assigned to immediate ( n = 15 ) or delayed ( n = 16 ) treatment . Acceptance-based behavior therapy led to statistically significant reductions in clinician-rated and self-reported GAD symptoms that were maintained at 3- and 9-month follow-up assessment s ; significant reductions in depressive symptoms were also observed . At posttreatment assessment 78 % of treated participants no longer met criteria for GAD and 77 % achieved high end-state functioning ; these proportions stayed constant or increased over time . As predicted , treatment was associated with decreases in experiential avoidance and increases in mindfulness Background : Mindfulness-based stress reduction ( MBSR ) proposes a systematic program for reduction of suffering associated with a wide range of medical conditions . Studies suggest improvements in general aspects of well-being , including quality of life ( QoL ) , coping and positive affect , as well as decreased anxiety and depression . Methods : A quasi-experimental study examined effects of an 8-week MBSR intervention among 58 female patients with fibromyalgia ( mean , 52 ± 8 years ) who underwent MBSR or an active social support procedure . Participants were assigned to groups by date of entry , and 6 subjects dropped out during the study . Self-report measures were vali date d German inventories and included the following scales : visual analog pain , pain perception , coping with pain , a symptom checklist and QoL. Pre- and postintervention measurements were made . Additionally , a 3-year follow-up was carried out on a subgroup of 26 participants . Results : Pre- to postintervention analyses indicated MBSR to provide significantly greater benefits than the control intervention on most dimensions , including visual analog pain , QoL subscales , coping with pain , anxiety , depression and somatic complaints ( Cohen d effect size , 0.40–1.10 ) . Three-year follow-up analyses of MBSR participants indicated sustained benefits for these same measures ( effect size , 0.50–0.65 ) . Conclusions : Based upon a quasi-r and omized trial and long-term observational follow-up , results indicate mindfulness intervention to be of potential long-term benefit for female fibromyalgia patients The purpose of this study was to gather data on the efficacy of a newly developed psychosocial group intervention for cancer patients , called mindfulness-based art therapy ( MBAT ) . One hundred and eleven women with a variety of cancer diagnoses were paired by age and r and omized to either an eight-week MBAT intervention group or a wait-list control group . Ninety-three participants ( 84 % ) completed both the pre- and post- study measurements . As compared to the control group , the MBAT group demonstrated a significant decrease in symptoms of distress ( as measured by the Symptoms Checklist-90-Revised ) and significant improvements in key aspects of health-related quality of life ( as measured by the Medical Outcomes Study Short-Form Health Survey ) . This investigation of MBAT provides initial encouraging data that support a possible future role for the intervention as a psychosocial treatment option for cancer patients Recovered recurrently depressed patients were r and omized to treatment as usual ( TAU ) or TAU plus mindfulness-based cognitive therapy ( MBCT ) . Replicating previous findings , MBCT reduced relapse from 78 % to 36 % in 55 patients with 3 or more previous episodes ; but in 18 patients with only 2 ( recent ) episodes corresponding figures were 20 % and 50 % . MBCT was most effective in preventing relapses not preceded by life events . Relapses were more often associated with significant life events in the 2-episode group . This group also reported less childhood adversity and later first depression onset than the 3-or-more-episode group , suggesting that these groups represented distinct population s. MBCT is an effective and efficient way to prevent relapse/recurrence in recovered depressed patients with 3 or more previous episodes This study evaluated mindfulness-based cognitive therapy ( MBCT ) , a group intervention design ed to train recovered recurrently depressed patients to disengage from dysphoria-activated depressogenic thinking that may mediate relapse/recurrence . Recovered recurrently depressed patients ( n = 145 ) were r and omized to continue with treatment as usual or , in addition , to receive MBCT . Relapse/recurrence to major depression was assessed over a 60-week study period . For patients with 3 or more previous episodes of depression ( 77 % of the sample ) , MBCT significantly reduced risk of relapse/recurrence . For patients with only 2 previous episodes , MBCT did not reduce relapse/recurrence . MBCT offers a promising cost-efficient psychological approach to preventing relapse/recurrence in recovered recurrently depressed patients OBJECTIVE To assess the effect of a meditation training program , Mindfulness-Based Stress Reduction ( MBSR ) , on depressive symptoms , psychological status , and disease activity in patients with rheumatoid arthritis ( RA ) through a r and omized , waitlist-controlled pilot study . METHODS Participants were r and omized to either an MBSR group , where they attended an 8-week course and 4-month maintenance program , or to a waitlist control group , where they attended all assessment visits and received MBSR free of charge after study end . Participants received usual care from their rheumatologists throughout the trial . Self-report question naires were used to evaluate depressive symptoms , psychological distress , well-being , and mindfulness . Evaluation of RA disease activity ( by Disease Activity Score in 28 joints ) included examination by a physician masked to treatment status . Adjusted means and mean OUTPUT: It can be concluded that MBSR has small effects on depression , anxiety and psychological distress in people with chronic somatic diseases . Integrating MBSR in behavioral therapy may enhance the efficacy of mindfulness based interventions INPUT: Nondirective ( ND ) , applied relaxation ( AR ) , and cognitive behavioral ( CBT ) therapies for generalized anxiety disorder ( GAD ) were compared . The latter 2 conditions were generally equivalent in outcome but superior to ND at post assessment . The 3 conditions did not differ on several process measures , and ND created the greatest depth of emotional processing . Follow-up results indicated losses in gains in ND , maintained gains in the other 2 conditions , especially CBT , and highest endstate functioning for CBT . AR and CBT thus contain active ingredients in the treatment of GAD ; support exists for further development of imagery exposure methods or cognitive therapy because of their likely role in promoting maintenance of change with this disorder . Expectancy for improvement was also associated with outcome , suggesting the need for further research on this construct for underst and ing the nature of GAD and its amelioration OBJECTIVE This report examines the impact of panic disorder and /or generalized anxiety disorder on quality of life and the implication s of these findings on nosological categories . METHOD A total of 357 subjects with a current episode of panic disorder and /or generalized anxiety disorder were diagnosed according to DSM-III-R criteria , using structured clinical interviews , as part of a prospect i ve , naturalistic , longitudinal , multicenter study of a clinical population with anxiety disorders . RESULTS There was a high degree of coexistence of anxiety disorders and major depressive disorder . Subjects with generalized anxiety disorder almost universally had other disorders , were the most likely to have at least one other anxiety disorder or major depressive disorder at intake , had the earliest age at onset , and had the worst emotional health rating . Subjects with panic disorder without agoraphobia had the most likelihood of a history of alcohol abuse . Nine percent of the subjects had a history of suicide attempts or gestures . CONCLUSIONS The subjects showed significant impairment in quality of life . The highly frequent coexistence of other anxiety disorders with generalized anxiety disorder and the overall lack of differences on many quality of life measures raise questions of nosology , particularly for generalized anxiety disorder A previous paper , Butler and Anastasiades ( Behaviour Research and Therapy 26 , 531 - 534 , 1988 ) presented evidence for three reliable predictors of response to Anxiety Management in patients with generalised anxiety disorder . It was argued there that these reflected severity of anxiety , demoralisation and depression . A second study ( Butler , Fennell , Robson & Gelder , Journal of Consulting and Clinical Psychology , 59 , 167 - 175 , 1991 ) has compared two treatments for GAD : Behaviour Therapy and Cognitive Behaviour Therapy . Data from this study is used here to answer two questions : ( i ) do the same three variables predict outcome in the second study ? The answer to this question is ' no ' ; and ( ii ) which variables contribute to prediction of outcome when these two treatments are compared ? Information presented here suggests that this depends partly on the nature of the treatment given . Outcome after behaviour therapy is predicted by initial levels of anxiety only , but the gains made are also relatively modest . Outcome after cognitive behaviour therapy is predicted by the degree to which ambiguous ( external ) information is interpreted as threatening . Thus a cognitive variable contributes reliably to the prediction of outcome after a cognitive treatment , but does not predict in the same way to outcome after a behavioural treatment Among a sample of 767 high utilizers of health care , 51 % were identified as distressed by an elevated score on the SCL anxiety and depression scales , the SCL somatization scale , or by their primary -care physician . These distressed high utilizers were found to have a high prevalence of chronic medical problems and significant limitation of activities caused by illness . In the prior year , they made an average of 15 medical visits and 15 telephone calls to the clinic . The Diagnostic Interview Schedule was completed on 119 distressed high utilizers r and omly assigned to an intervention group in a controlled trial of psychiatric consultation . The following DSM-III-R disorders were most common : major depression 23.5 % , dysthymic disorder 16.8 % , generalized anxiety disorder 21.8 % , and somatization disorder 20.2 % . Two thirds had a lifetime history of major depression . The examination result ed in an improved diagnostic assessment for 40 % of intervention patients and a revised treatment plan for 67 % OBJECTIVE The authors present data from a pilot research program initiated to develop , refine , and test the outcomes of CBT-GAD/PC , a version of cognitive-behavior therapy ( CBT ) that targets the needs of older adults with generalized anxiety disorder ( GAD ) in primary care ( PC ) . METHODS The study involved a small , r and omized clinical trial comparing the impact of CBT-GAD/PC to usual care ( UC ) in a sample of 12 older medical patients with GAD . RESULTS Outcome data suggested significant improvements in worry and depression after CBT-GAD/PC , relative to UC . CONCLUSION Authors discuss results in terms of the " real-world " applicability of this treatment for late-life GAD , and present implication s for future research Cognitive therapy ( CT ) and applied relaxation ( AR ) as treatments of generalized anxiety disorder ( GAD ) were compared in a sample of 45 patients of a community mental health center , r and omly allocated to condition . Patients were assessed before and after a 12-session treatment , and at one and six months follow-ups . There was a 20 % drop out from CT and 15 % from AR ( NS ) , with some drop outs being considerably improved . Both completers and intention-to-treat analyses revealed that both treatments were effective ( ESs of composite and specific measures ranging from 0.53 to 1.14 ) . At one-month follow-up AR tended to do better than CT , with CT catching up with AR at six months . Recovery rates and proportions of patients showing reliable change OUTPUT:

Psychological therapy based on CBT principles is effective in reducing anxiety symptoms for short-term treatment of GAD . The body of evidence comparing CBT with other psychological therapies is small and heterogeneous , which precludes drawing conclusions about which psychological therapy is more effective .