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Clinical NLP Lab 30

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In the evaluation of a diagnostic imaging test for the diagnosis of a particular illness in a particular category of patients , the test should be construed as leading to a test result in the sense of a set of descriptive readings from the image(s ) , not interpretation of these ; and in the evaluation of the test , therefore , the first challenge is the translation of each test result ( set of readings ) into the corresponding probability that the illness is present . This interpretive translation should not be subjective , nor should it be based on an objective algorithm founded on clinical judgments . Instead , a suitable diagnostic probability function ( of the elements in the test result ) should be derived empirically by logistic regression analysis of suitable data . We illustrate this alternative outlook by re analysis of the data from the Prospect i ve Investigation of Pulmonary Embolism Diagnosis 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 Abstract Objective : To assess the extent to which different forms of summarising diagnostic test information influence general practitioners ' ability to estimate disease probabilities . Design : Controlled question naire study . Setting : Three Swiss conferences in continuous medical education . Participants : 263 general practitioners . Intervention : Question naire with multiple choice questions about terms of test accuracy and a clinical vignette with the results of a diagnostic test described in three different ways ( test result only , test result plus test sensitivity and specificity , test result plus the positive likelihood ratio presented in plain language ) . Main outcome measures : Doctors ' knowledge and application of terms of test accuracy and estimation of disease probability in the clinical vignette . Results : The correct definitions for sensitivity and predictive value were chosen by 76 % and 61 % of the doctors respectively , but only 22 % chose the correct answer for the post-test probability of a positive screening test . In the clinical vignette doctors given the test result only overestimated its diagnostic value ( median attributed likelihood ratio (aLR)=9.0 , against 2.54 reported in the literature ) . Providing the scan 's sensitivity and specificity reduced the overestimation ( median aLR=6.0 ) but to a lesser extent than simple wording of the likelihood ratio ( median aLR=3.0 ) . Conclusion : Most general practitioners recognised the correct definitions for sensitivity and positive predictive value but did not apply them correctly . Conveying test accuracy information in simple , non-technical language improved their ability to estimate disease probabilities accurately . What is already known on this topic Many doctors confuse the sensitivity of clinical tests and their positive predictive value Doctors tend to overestimate information derived from such tests and underestimate information from a patient 's clinical history Most primary research on diagnostic accuracy is reported using sensitivity and specificity or likelihood ratios What this study adds In a cohort of experienced Swiss general practitioners most were unable to interpret correctly numerical information on the diagnostic accuracy of a screening test When presented with a positive result alone they grossly overestimated its value Adding information on the test 's sensitivity and specificity moderated these overestimates , and expressing the same numerical information as a positive likelihood ratio in simple , non-technical language brought the estimates still closer to their true Each year 1.5 million patients are admitted to coronary-care units ( CCUs ) for suspected acute ischemic heart disease ; for half of these , the diagnosis is ultimately \" ruled out . \" In this study , conducted in the emergency rooms of six New Engl and hospitals ranging in type from urban teaching centers to rural nonteaching hospitals , we sought to develop a diagnostic aid to help emergency room physicians reduce the number of their CCU admissions of patients without acute cardiac ischemia . From data on 2801 patients , we developed a predictive instrument for use in a h and -held programmable calculator , which requires only 20 seconds to compute a patient 's probability of having acute cardiac ischemia . In a prospect i ve trial that included 2320 patients in the six hospitals , physicians ' diagnostic specificity for acute ischemia increased when the probability value determined by the instrument was made available to them . Rates of false-positive diagnosis decreased without any increase in rates of false-negative diagnosis . Among study patients with a final diagnosis of \" not acute ischemia , \" the number of CCU admissions decreased 30 per cent , without any increase in missed diagnoses of ischemia . The proportion of CCU admissions that represented patients without acute ischemia dropped from 44 to 33 per cent . Widespread use of this predictive instrument could reduce the number of CCU admissions in this country by more than 250,000 per year OBJECTIVE To determine the accuracy of ultrasound scan in the diagnosis of endometrial hyperplasia and cancer in postmenopausal bleeding . DESIGN A prospect i ve diagnostic accuracy study ( 1996 - 97 ) . SETTING Minimal access surgical training centers in two large teaching hospitals . METHODS Ultrasound scan and outpatient endometrial sampling were performed on 96 patients with postmenopausal bleeding . Patients unable to have these outpatient procedures had a formal inpatient hysteroscopy and curettage . Test performance characteristics were computed for ultrasound scan comparing its estimate of endometrial thickness with histologic diagnosis that served as a ' gold ' st and ard . OUTCOME MEASURES Accuracy of the ultrasonic endometrial thickness was estimated using sensitivity , specificity and predictive values for binary data . For multilevel data , the diagnostic accuracy was computed using likelihood ratios ( LRs ) . An LR < decreased the probability that endometrial hyperplasia/cancer was present , whereas an LR > 1 increased the probability that such lesion was present . RESULTS Using endometrial thickness > or = 4 mm , the sensitivity of ultrasound to detect the endometrial malignancy was 92.9 % , the specificity was 500 % , and the positive and negative predictive values were 24.1 % and 97.6 % respectively . Analysis using likelihood ratio ( LR ) revealed that LR was 0.14 for endometrial thickness > or = 4.0 mm , 0.94 for endometrial thickness 4.1 - 9.0 mm , and 3.3 for endometrial thickness > 9.0 mm . CONCLUSION In women with postmenopausal bleeding , malignancy can probably be safely excluded if sonographic endometrial thickness is < or = 4.0 mm . However , the probability of endometrial hyperplasia/cancer is not particularly altered by the knowledge that endometrial thickness on scan is > 4.0 mm BACKGROUND Systematic review s that \" compare \" the accuracy of 2 or more tests often include different sets of studies for each test . PURPOSE To investigate the availability of direct comparative studies of test accuracy and to assess whether summary estimates of accuracy differ between meta-analyses of noncomparative and comparative studies . DATA SOURCES Systematic review s in any language from the Data base of Abstract s of Review s of Effects and the Cochrane Data base of Systematic Review s from 1994 to October 2012 . STUDY SELECTION 1 of 2 assessors selected review s that evaluated at least 2 tests and identified meta-analyses that included both noncomparative studies and comparative studies . DATA EXTRACTION 1 of 3 assessors extracted data about review and study characteristics and test performance . DATA SYNTHESIS 248 review s compared test accuracy ; of the 6915 studies , 2113 ( 31 % ) were comparative . Thirty-six review s ( with 52 meta-analyses ) had adequate studies to compare results of noncomparative and comparative studies by using a hierarchical summary receiver-operating characteristic meta-regression model for each test comparison . In 10 meta-analyses , noncomparative studies ranked tests in the opposite order of comparative studies . A total of 25 meta-analyses showed more than a 2-fold discrepancy in the relative diagnostic odds ratio between noncomparative and comparative studies . Differences in accuracy estimates between noncomparative and comparative studies were greater than expected by chance ( P < 0.001 ) . LIMITATION A paucity of comparative studies limited exploration of direction in bias . CONCLUSION Evidence derived from noncomparative studies often differs from that derived from comparative studies . Robustly design ed studies in which all patients receive all tests or are r and omly assigned to receive one or other of the tests should be more routinely undertaken and are preferred for evidence to guide test selection . PRIMARY FUNDING SOURCE National Institute for Health Research ( United Kingdom ) \n Output:\n " }, { "from": "agent", "value": "Most primary accuracy studies lack statistical power to do this , particularly because of the small absolute number of disease events per test included in the diagnostic work .\nSynthesis using their raw data can overcome this problem , but meta-analysts will have limited success if there are difficulties in obtaining the large majority of valid studies , without ' missing ' data on the tests relevant in clinical decision-making ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: INTRODUCTION The purpose s of the study were to evaluate the immediate damage to roots and periodontal structures after initial miniscrew implant ( MSI ) placement and the short- and long-term damage after MSIs were left in situ . METHODS The roots of the maxillary second , third , and fourth premolars of 7 mature beagle dogs were r and omly assigned to undergo immediate , short-term ( left for 6 weeks ) , or long-term ( left for 12 weeks ) damage . Intentional damage was inflicted with self-tapping screws ( 1.8 x 8 mm ) placed with a stent . Alternating tetracycline and calcein labels were administered at 6-week intervals . Undecalcified sections were stained and evaluated histologically to determine the extent of damage ; healing was evaluated by using fluorescence labels . RESULTS Histology showed damage to 73.8 % of the teeth , ranging from displacement of bone into the periodontal ligament to invasion of the pulp chamber . Displacement of bone into the periodontal ligament and direct damage to the periodontal ligament occurred in 3 ( 7.2 % ) instances . Damage was isolated to the cementum of 8 ( 19.0 % ) teeth , whereas damage occurred in the dentin of 11 ( 26.2 % ) teeth . Loss of bone in the furcation was evident in 3 ( 7.2 % ) teeth , and severe damage into the pulp occurred in 6 ( 14.2 % ) teeth . No differences in the amounts of damage were evident between the immediate , short- , and long-term groups . Healing often occurred with cementum around the unloaded MSIs . CONCLUSIONS Extensive damage can be caused by MSIs , with little to no differences evident over time . Unloaded MSIs that remain in contact with roots of teeth can show varying degrees of healing PURPOSE The aim of this prospect i ve clinical study was to assess the risk factors associated with failure of mini-implants used for orthodontic anchorage . MATERIAL S AND METHODS A total of 140 mini-implants in 44 patients , including 48 miniplates and 92 freest and ing miniscrews , were examined in the study . A variety of orthodontic loads were applied . The majority of implants were placed in the posterior maxilla ( 104/140 ) , and the next most common location was the posterior m and ible ( 34/140 ) . RESULTS A cumulative survival rate of 89 % ( 125/140 ) was found by Kaplan-Meier analysis . There was no significant difference in the survival rate between miniplates and freest and ing miniscrews , but miniplates were used in more hazardous situations . The Cox proportional-hazards regression model identified anatomic location and peri-implant soft tissue character as 2 independent prognostic indicators . The estimated relative risk of implant failure in the posterior m and ible was 1.101 ( 95 % confidence interval , 0.942 to 1.301 ; P = .046 ) . The risk ratio of failure for implants surrounded by nonkeratinized mucosa was 1.117 ( 95 % confidence interval , 0.899 to 1.405 ; P = .026 ) . DISCUSSION AND CONCLUSION The results confirmed the effectiveness of orthodontic mini-implants , but in certain situations adjustment of the treatment plan or modifications in the technique of implant placement may lead to improved success rates INTRODUCTION The purpose of this study was to investigate the effects of the diameter and shape of orthodontic mini-implants ( OMIs ) on microdamage to the cortical bone during implant placement . METHODS Twenty-eight self-drilling OMIs ( Bio material s Korea , Seoul , Korea ; length , 6 mm ; diameters , 1.5 and 2 mm ; cylindrical and tapered shapes ; classified as 1.5C , 2C , 1.5 T , and 2 T ) were placed with a surgical device in the tibias of 7 New Zeal and white rabbits ( mature males ; mean age , 6 months ; mean weight , 3.1 kg ) . Four OMIs of each type per rabbit were placed r and omly . Maximum insertion torque ( MIT ) was measured . Immediately after placement of the OMIs , the block of bone with the OMI was harvested . Cortical bone thickness was measured by using microcomputed tomography , and histomorphometric analyses of the number of cracks ( NC ) , accumulated crack length ( ACL ) , maximum radius of the crack ( MRC ) , and longest crack ( LC ) were performed . Kruskal-Wallis and Mann-Whitney U tests with the Bonferroni adjustment were done for statistical analyses . RESULTS Increased diameter ( 1.5C<2C and 1.5T<2 T ) and tapering ( 1.5C<2 T ) result ed in increased values of MIT , NC , and LC ( P < 0.01 , respectively ) . Similarly , with increased diameters ( 1.5C and 1.5T<2C and 2 T ) , there were increases of ACL and MRC ( P < 0.001 , respectively ) . However , there were no differences in the values of MIT , NC , ACL , MRC , and LC between the cylindrical and tapered OMIs with the same diameters ( 1.5C and 1.5 T , 2C and 2 T ) . CONCLUSIONS OMIs with larger diameters and tapered shapes caused greater microdamage to the cortical bone ; this might affect bone remodeling and the stability of the OMIs PURPOSE This study evaluated the survival parameters of single-tooth implants through clinical and radiographic analysis . MATERIAL S AND METHODS Implants were restored within a 24-hour period with a provisional crown design ed to receive an occlusal masticatory load . This approach was compared to implants restored after a healing period ( the control group ) . Forty-six implants were placed in 23 patients who were each treated with 2 Frialit-2 implants placed in sites between the second premolar in the maxilla or m and ible . The manufacturer 's recommended formal surgical procedure was followed , and primary stability was st and ardized with a minimum insertion torque of 20 Ncm . The sites were r and omly selected , and the clinical and radiographic parameters were st and ardized with individual templates . RESULTS Data were collected at 24 h , and at 1 , 3 , 6 , 12 , 18 , and 24 months . The experimental group included 10 failed implants ; 9 of the failed implants had been placed with an insertion torque of 20 Ncm . One implant from the control group failed during the 24-month follow-up period . The survival rate was independent of implant length , site position , and bone quality and quantity . Relative risk for implant failure was associated with insertion torque ( relative risk 0.79 [ CI : 0.66 - 0.930 ] ; Cox regression ) ( P < or = .007 ) , in the experimental group but was not significant for those in the control group ( ie , implants placed after a healing period ; relative risk 0.78 [ CI : 0.34 - 1.78 ] ; Cox regression ) ( P < or = .057 ) . To achieve osseointegration , it was found that an insertion torque above 32 Ncm was necessary ( chi2= 15.68 ; P < or = .004 ) . DISCUSSION A careful evaluation is necessary for a better underst and ing of the survival rates of immediately loaded implants . In this study , insertion torque was associated with the potential for risk , which can be decreased by 20 % per 9.8 Ncm added . CONCLUSION Given these results , and considering the number of patients treated , immediate provisional crowns should only be proposed with early loading if an appropriate initial insertion torque has been applied INTRODUCTION We compared the stability of 3- and 6-mm long miniscrew implants ( MSIs ) loaded with orthopedic force levels . METHODS Using a split-mouth experimental design , we placed MSIs into the jaws of 5 mature beagle dogs and immediately loaded them for 6 weeks . Continuous forces were applied by reciprocally loading pairs of MSIs with nickel-titanium coil springs . The m and ibles had the 3-mm MSIs r and omly loaded with forces of 600 or 900 g. In the maxilla , the 3- and 6-mm MSIs were r and omly assigned and loaded with 600 g of force . An unloaded , control MSI was placed in each quadrant . Overall success was defined as MSIs that remained intact ; net success rates excluded MSIs that had sheared off and all implants placed in a dog that frequently chewed his run bars and food bowl . RESULTS The overall success rates of the loaded and the control 6-mm MSIs were 100 % . Overall and net success rates for the 3-mm experimental MSIs were 66.7 % and 95.2 % , respectively . Similarly , the overall and net success rates of the 3-mm control MSIs were 66.7 % and 81.8 % , respectively . The overall success rates of the 3-mm m and ibular MSIs loaded with 900 and 600 g of force were both 60 % ; their net success rates were 100 % with 900 g and 85.7 % with 600 g. Overall success rates of the 3-mm experimental MSIs in the maxilla and the m and ible were 80 % and 60 % , repectively . The net success rates were 100 % ( maxilla ) and 85.7 % ( m and ible ) . There were no significant ( P > 0.05 ) differences in stability associated with force or location . The loaded 3- and 6-mm MSI pairs demonstrated significant decreases in interimplant distance , averaging 2.2 and 1.8 mm , respectively ; the 3-mm MSIs loaded with 900 g showed significantly more displacement than those loaded with 600 g. CONCLUSIONS Success rates of immediately loaded 3-mm MSIs were significantly lower than those of immediately loaded 6-mm MSIs . Neither force nor location explained differences in the success rates . The linear displacements of the MSIs were associated with load amount rather than implant length Miniscrews have been used in recent years for anchorage in orthodontic treatment . However , it is not clear whether the miniscrews are absolutely stationary or move when force is applied . Sixteen adult patients with miniscrews ( diameter = 2 mm , length = 17 mm ) as the maxillary anchorage were included in this study . Miniscrews were inserted on the maxillary zygomatic buttress as a direct anchorage for en masse anterior retraction . Nickel-titanium closed-coil springs were placed for the retraction 2 weeks after insertion of the miniscrews . Cephalometric radiographs were taken immediately before force application ( T1 ) and 9 months later ( T2 ) . The cephalometric tracings at T1 and T2 were superimposed for the overall best fit on the structures of the maxilla , cranial base , and cranial vault to determine any movement of the miniscrews . The miniscrews were also evaluated clinical ly for their mobility ( 0 : no movement , 1 : < or = 0.5 mm , 2 : 0.5 - 1.0 mm , 3 : > 1.0 mm ) . The mobility of all miniscrews was 0 at T1 and T2 . On average , the miniscrews tipped forward significantly , by 0.4 mm at the screw head . The miniscrews were extruded and tipped forward ( -1.0 to 1.5 mm ) in 7 of the 16 patients . Miniscrews are a stable anchorage but do not remain absolutely stationary throughout orthodontic loading . They might move according to the orthodontic loading in some patients . To prevent miniscrews hitting any vital organs because of displacement , it is recommended that they be placed in a non-tooth-bearing area that has no foramen , major nerves , or blood vessel pathways , or in a tooth-bearing area allowing 2 mm of safety clearance between the miniscrew and dental root The possibility of using osseointegrated implants for orthodontic anchorage is well known . When absolute orthodontic anchorage is needed , mini-implants can be inserted in the non-alveolar bone area ( e.g. palatal process or retromolar areas of the m and ible ) . However , what happens to these implants at the end of treatment can be a problem as neither trephine explantation nor simply leaving the subgingival part of the implant in the bone permanently are acceptable solutions . In this investigation , 16 Exacta small screw titanium implants ( Exacta MS series conical profile , with a diameter of 3.3 mm and a length of 7.0 mm ) were used as indirect orthodontic anchorage in 16 adult patients . The site of implant placement was established based on radiological investigations . There were eight palatal and eight retromolar implants inserted in seven males and nine females ( mean age 30.3 years ) . On completion of treatment , the implants were unscrewed to the maximum limits of their removal torque values ( RTVs ) and the obtained data were analysed using a t-test . An in vitro study before the clinical trial was also undertaken to determine the maximum mechanical resistance of the unscrewing system . The clinical procedure and average RTV ( 67.91 + /- 12.47 N/cm ) were considered compatible with safe , non-invasive removal of the implant followed by rapid anatomical reconstruction of the area involved OBJECTIVE To test the hypothesis that there is no difference in the stability and resistance to rotational moments of early loaded s and blasted and acid-etched ( SLA ) mini-implants and those of machined-surface implants of the same size and shape . MATERIAL S AND METHODS A r and omized complete block design was used in 12 skeletally mature \n Output:\n " }, { "from": "agent", "value": "Currently , no evidence indicates that specific maximum insertion torque levels are associated with higher success rates for orthodontic mini-implants ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The contribution of acute respiratory infection control project within the framework of micro-credit-based development intervention in promoting maternal knowledge of ARIs in children was assessed . Data came from a cross-sectional survey of 2814 mothers of under 5-y-old children residing in 200 r and omly selected villages in five districts in Bangladesh . Findings revealed that the ARI control project had significant positive effects in raising knowledge of clinical signs and preventive measures . When ARI control project activities were integrated with the credit-based development initiative , maternal knowledge improved even further . The study concludes that the micro-credit programme can be a catalytic agent in raising health knowledge among poor women in developing countries BACKGROUND The Integrated Management of Childhood Illness ( IMCI ) strategy is design ed to address major causes of child mortality at the levels of community , health facility , and health system . We assessed the effectiveness of facility-based IMCI in rural Tanzania . METHODS We compared two districts with facility-based IMCI and two neighbouring comparison districts without IMCI , from 1997 to 2002 , in a non-r and omised study . We assessed quality of case-management for children 's illness , drug and vaccine availability , and supervision involving case-management , through a health-facility survey in 2000 . Household surveys were used to assess child-health indicators in 1999 and 2002 . Survival of children was tracked through demographic surveillance over a predefined 2-year period from mid 2000 . Further information on context ual factors was gathered through interviews and record review . The economic cost of health care for children in IMCI and comparison districts was estimated through interviews and record review at national , district , facility , and household levels . FINDINGS During the IMCI phase-in period , mortality rates in children under 5 years old were almost identical in IMCI and comparison districts . Over the next 2 years , the mortality rate was 13 % lower in IMCI than in comparison districts ( 95 % CI -7 to 30 or 5 to 21 , depending on how adjustment is made for district-level clustering ) , with a rate difference of 3.8 fewer deaths per 1000 child-years . Context ual factors , such as use of mosquito nets , all favoured the comparison districts . Costs of children 's health care with IMCI were similar to or lower than those for case-management without IMCI . INTERPRETATION Our findings indicate that facility-based IMCI is good value for money , and support widespread implementation in the context of health-sector reform , basket funding , good facility access , and high utilisation of health facilities OBJECTIVES To characterize community health worker ( CHW ) performance using an algorithm for managing common childhood illnesses in Siaya District , Kenya , we conducted CHW evaluations in 1998 , 1999 , and 2001 . METHODS R and omly selected CHWs were observed managing sick outpatient and inpatient children at a hospital , and their management was compared with that of an expert clinician who used the algorithm . RESULTS One hundred , 108 , and 114 CHWs participated in the evaluations in 1998 , 1999 , and 2001 , respectively . The proportions of children treated \" adequately \" ( with an antibiotic , antimalarial , oral rehydration solution , or referral , depending on the child 's disease classifications ) were 57.8 % , 35.5 % , and 38.9 % , respectively , for children with a severe classification and 27.7 % , 77.3 % , and 74.3 % , respectively , for children with a moderate ( but not severe ) classification . CHWs adequately treated 90.5 % of malaria cases ( the most commonly encountered classification ) . CHWs often made mistakes assessing symptoms , classifying illnesses , and prescribing correct doses of medications . CONCLUSIONS Deficiencies were found in the management of sick children by CHWs , although care was not consistently poor . Key reasons for the deficiencies appear to be guideline complexity and inadequate clinical supervision ; other possible causes are discussed OBJECTIVE The objective of this study was to assess the effect of Integrated Management of Childhood Illness ( IMCI ) case management training on the use of antimicrobial drugs among health-care workers treating young children at first-level facilities . Antimicrobial drugs are an essential child-survival intervention . Ensuring that children younger than five who need these drugs receive them promptly and correctly can save their lives . Prescribing these drugs only when necessary and ensuring that those who receive them complete the full course can slow the development of antimicrobial resistance . METHODS Data collected through observation-based surveys in r and omly selected first-level health facilities in Brazil , Ug and a and the United Republic of Tanzania were statistically analysed . The surveys were carried out as part of the multi-country evaluation of IMCI effectiveness , cost and impact ( MCE ) . FINDINGS Results from three MCE sites show that children receiving care from health workers trained in IMCI are significantly more likely to receive correct prescriptions for antimicrobial drugs than those receiving care from workers not trained in IMCI . They are also more likely to receive the first dose of the drug before leaving the health facility , to have their caregiver advised how to administer the drug , and to have caregivers who are able to describe correctly how to give the drug at home as they leave the health facility . CONCLUSIONS IMCI case management training is an effective intervention to improve the rational use of antimicrobial drugs for sick children visiting first-level health facilities in low-income and middle-income countries BACKGROUND No satisfactory strategy for reducing high child mortality from malaria has yet been established in tropical Africa . We compared the effect on under-5 mortality of teaching mothers to promptly provide antimalarials to their sick children at home , with the present community health worker approach . METHODS Of 37 tabias ( cluster of villages ) in two districts with hyperendemic to holoendemic malaria , tabias reported to have the highest malaria morbidity were selected . A census was done which included a maternity history to determine under-5 mortality . Tabias ( population 70,506 ) were paired according to under-5 mortality rates . One tabia from each pair was allocated by r and om number to an intervention group and the other was allocated to the control group . In the intervention tabias , mother coordinators were trained to teach other local mothers to recognise symptoms of malaria in their children and to promptly give chloroquine . In both intervention and control tabias , all births and deaths of under-5s were recorded monthly . FINDINGS From January to December 1997 , 190 of 6383 ( 29.8 per 1000 ) children under-5 died in the intervention tabias compared with 366 of 7294 ( 50.2 per 1000 ) in the control tabias . Under-5 mortality was reduced by 40 % in the intervention localities ( 95 % CI from 29.2 - 50.6 ; paired t test , p<0.003 ) . For every third child who died , a structured verbal autopsy was undertaken to ascribe cause of mortality as consistent with malaria or possible malaria , or not consistent with malaria . Of the 190 verbal autopsies , 13 ( 19 % ) of 70 in the intervention tabias were consistent with possible malaria compared with 68 ( 57 % ) of 120 in the control tabias . INTERPRETATION A major reduction in under-5 mortality can be achieved in holoendemic malaria areas through training local mother coordinators to teach mothers to give under-5 children antimalarial drugs A survey was done in June 1983 in Saradidi , Kenya , one year after the inception of a community-based malaria control programme to determine if people were obtaining malaria treatment from volunteer village health helpers ( VHH 's ) chosen by the community . Ten of 36 villages were r and omly chosen . From these ten villages , 100 households were r and omly selected and 222 people ten years of age or more were interviewed ; 113 ( 50.9 % ) had a history of malaria in the previous two weeks and 82 ( 72.6 % of 113 ) had taken medicine for malaria in that period . Of these 82 , 51.2 % obtained drug from the VHH , 28 % purchased it from a shop , 12.2 % from a health facility , 4.9 % from family members and 3.7 % from a private practitioner or a shop outside Saradidi . Reasons given for not obtaining treatment from the VHH 's among the 40 people who went elsewhere for treatment included : the VHH was not at home when needed ( 35 % ) ; the VHH had no drugs ( 22.5 % ) ; the patient was too sick for the VHH to treat ( 10 % ) ; had drugs already in the home ( 10 % ) ; ' not registered ' with VHH ( 10 % ) ; VHH ' no good ' ( 7.5 % ) ; and more ' convenient ' to go elsewhere ( 5 % ) . Similar results found on question ing the mother were obtained for 103 children under nine years old in these households ; 67 ( 65.0 % ) children had a history of malaria in the previous two weeks and 59 ( 88.1 % ) of these 67 children had received antimalarial treatment . The VHH was the principal source of treatment ( 50.8 % of 59 ) , followed by health facilities ( 20.3 % ) and shops ( 18.6 % ) . ( ABSTRACT TRUNCATED AT 250 WORDS Save the Children/USA in collaboration with the Ministry of Health of Mali has established over 300 village drug kits in southern Mali since 1996 . A cluster-r and omized trial was conducted between November 2001 and February 2002 in 10 health zones of Bougouni District to evaluate an intervention to ( i ) improve the skills of the village drug kit managers to counsel parents on correct home administration of chloroquine ( CQ ) , and ( ii ) increase the referral of sick children to community health centres ( CHC ) . Children 's carers were interviewed 5 d after the sale of CQ about knowledge of danger signs requiring referral , quality of counselling , administration of CQ , and referral . The intervention was associated with significant increases in knowledge of danger signs requiring referral , reported quality of counselling by the manger of the drug kit , and correct administration of CQ in the home . Parents reported that 42.1 % of children in the intervention group were referred to the CHC by the drug kit manager compared with 11.2 % in the comparison group ( odds ratio = 7.12 , 95 % CI 2.62 - 19.38 ) . CHC registers indicated that 87.0 % of referrals recorded in drug kit referral notebooks arrived at the health centre . Further research is needed to increase the effectiveness of the counselling and the community referral mechanism tested in this study In rural , malaria-endemic Burkina Faso , we evaluated the impact of the use of pre-packaged antimalarial drugs ( PPAM ) , by mothers in the home , on the progression of disease in children from uncomplicated fever to severe malaria . In each village of one province , a core group of opinion leaders ( mainly older mothers ) was trained in the management of uncomplicated malaria , including the administration of PPAM . Full courses of antimalarial ( chloroquine ) and antipyretic ( aspirin ) drugs were packaged in age-specific bags and made widely available through community health workers who were supplied through the existing drug distribution system . Drugs were sold under a cost-recovery scheme . Local schoolteachers conducted surveys in a r and om sample of 32 villages at the end of the high transmission seasons in 1998 and 1999 . Disease history and the treatment received were investigated for all children under the age of 6 years having suffered from a fever episode in the previous 4 weeks . ' Uncomplicated malaria ' was defined as every episode of fever and ' severe malaria ' as every episode of fever followed by convulsions or loss of consciousness . During the study period , 56%[95 % confidence interval ( CI ) 50 - 62 % ] of 3202 fever episodes in children under 6 years of age were treated promptly by mothers with the pre-packaged drugs made available by the study . A total of 59 % of children receiving PPAM were reported to have received the drugs over the prescribed 3-day period , while 52 % received the correct age-specific dose . PPAM use was similar among literate ( 61 % ) and non-literate mothers ( 55 % ) ( P = 0.08 ) . The overall reported risk of developing severe malaria was 8 % . This risk was lower in children treated with PPAM ( 5 % ) than in children not treated with PPAM ( 11 % ) ( risk ratio = 0.47 ; 95 % CI 0.37 , 0.60 ; P < 0.0001 ) . This estimate of the impact of PPAM was largely unchanged when account was taken of potential confounding by age , sex , maternal literacy status , year or village . Our findings support the view that , after appropriate training and with adequately packaged drugs made available , mothers can recognize and treat promptly and correctly malarial episodes in their children and , by doing so , reduce the incidence of severe disease BACKGROUND We report the preliminary findings from a continuing cluster r and omised evaluation of the Integrated Management of Childhood Illness ( IMCI ) strategy in Bangladesh . METHODS 20 first-level outpatient facilities in the Matlab sub-district and their catchment areas were r and omised to either IMCI or st and ard care . Surveys were done in households and in health facilities at baseline and were repeated about 2 years after implementation . Data on use of health facilities were recorded . IMCI implementation included health worker training , health systems support , and community level activities guided by formative research . F \n Output:\n " }, { "from": "agent", "value": "Of the seven models , that of CHW pneumonia case management ( Model 6 ) has the strongest evidence for an impact on mortality ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In preterm infants receiving supplemental oxygen , manual control of the inspired oxygen fraction is often time-consuming and inappropriate . We developed a system for automatic oxygen control and hypothesized that this system is more effective than routine manual oxygen control in maintaining target arterial oxygen saturation levels . We performed a r and omized controlled crossover clinical trial in 12 preterm infants receiving nasal continuous positive airway pressure and supplemental oxygen . Periods with automatic and routine manual oxygen control were compared with periods of optimal control by a fully dedicated person . The median ( range ) percentage of time with arterial oxygen saturation levels within target range ( 87 - 96 % ) was 81.7 % ( 39.0 - 99.8 ) for routine manual oxygen control , 91.0 % ( 41.4 - 99.3 ) for optimal control , and 90.5 % ( 59.0 - 99.4 ) for automatic control ( ANOVA : p = 0.01 ) . Pairwise post hoc comparisons revealed a statistically significant difference between automatic and routine manual oxygen control ( Dunnett 's test : p = 0.02 ) . The frequency of manual oxygen adjustments was lowest in automatic control ( Friedman 's test : p < 0.001 ) . Automatic oxygen control may optimize oxygen administration to preterm infants receiving nasal continuous positive airway pressure and reduce nursing time spent with oxygen control Background It is possible that cross-over studies included in current systematic review s are being inadequately assessed , because the current risk of bias tools do not consider possible biases specific to cross-over design . We performed this study to evaluate whether this was being done in cross-over studies included in Cochrane Systematic Review s ( CSRs ) . Methods We search ed the Cochrane Library ( up to 2013 issue 5 ) for CSRs that included at least one cross-over trial . Two authors independently undertook the study selection and data extraction . A r and om sample of the CSRs was selected and we evaluated whether the cross-over trials in these CSRs were assessed according to criteria suggested by the Cochrane h and book . In addition we reassessed the risk of bias of these cross-over trials by a checklist developed form the Cochrane h and book . Results We identified 688 CSRs that included one or more cross-over studies . We chose a r and om sample of 60 CSRs and these included 139 cross-over studies . None of these CSRs undertook a risk of bias assessment specific for cross-over studies . In fact items specific for cross-over studies were seldom considered anywhere in quality assessment of these CSRs . When we reassessed the risk of bias , including the 3 items specific to cross-over trials , of these 139 studies , a low risk of bias was judged for appropriate cross-over design in 110(79 % ) , carry-over effects in 48(34 % ) and for reporting data in all stages of the trial in 114(82 % ) . Assessment of biases in cross-over trials could affect the GRADE assessment of a review ’s findings . Conclusion The current Cochrane risk of bias tool is not adequate to assess cross-over studies . Items specific to cross-over trials leading to potential risk of bias are generally neglected in CSRs . A proposed check list for the evaluation of cross-over trials is provided OBJECTIVE To assess the effect of automated adjustment of the inspired oxygen fraction ( FiO2 ) on arterial oxygen saturation ( SpO2 ) and cerebral tissue oxygen saturation ( SctO2 ) in very low birth weight infants with frequent fluctuations in oxygenation . STUDY DESIGN Fifteen infants ( median gestational age , 25 weeks [ range , 23 - 28 weeks ] ; median age , 34 days [ range , 19 - 74 days ] ) were assigned in r and om sequence to 24 hours of automated adjustment of FiO2 or manual adjustment of FiO2 . Primary outcome measurements were time within the SpO2 target range and the area under the curve above and below a defined SctO2 range . RESULTS Percentage of time within the SpO2 target range increased during automated FiO2 control ( 76.3 % ± 9.2 % vs 69.1 % ± 8.2 % for manual ; P < .01 ) . Prolonged episodes with SpO2 < 88 % of > 60 seconds duration ( median , 115 episodes [ range , 67 - 240 ] vs 54 episodes [ range , 7 - 184 ] ; P < .01 ) and of > 180 seconds duration ( median , 13 episodes [ range , 6 - 39 ] vs 2 episodes [ range , 0 - 5 ] ; P < .01 ) decreased significantly during the automated period . Percentage of time with SpO2 > 96 % decreased during automated control ( 6.6 % ± 4.4 % vs 10.4 % ± 3.3 % ; P < .02 ) . There was no significant difference in FiO2 exposure . The area ( deviation × time ) below and above the defined SctO2 threshold did not differ between the 2 periods ( median , 59.7%*seconds [ range , 17.2%-208.3 % ] for manual vs 49.0%*seconds [ range , 4.3%-193.7 % ] for automated ; P = .36 ) . CONCLUSION Automated FiO2 control in preterm infants with frequent SpO2 fluctuations significantly increased the time within the SpO2 target range and reduced the incidence of prolonged hypoxemic events compared with manual FiO2 adjustment , but did not significantly affect cerebral tissue oxygenation BACKGROUND AND OBJECTIVE : In preterm infants receiving supplemental oxygen , routine manual control ( RMC ) of the fraction of inspired oxygen ( FIO2 ) is often difficult and time consuming . We developed a system for closed-loop automatic control ( CLAC ) of the FIO2 and demonstrated its short-term safety and efficacy in a single-center study . The objective of this study was to test the hypothesis that this system is more effective than RMC alone in maintaining arterial oxygen saturation within target levels when evaluated over 24 hours under routine conditions and with different target levels . METHODS : We performed a multicenter , r and omized controlled , crossover clinical trial in 34 preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure and supplemental oxygen . Twenty-four – hour periods with RMC were compared with 24-hour periods of RMC supported by CLAC . RESULTS : The median ( range ) percentage of time with arterial oxygen saturation levels within target range was 61.4 ( 31.5–99.5 ) for RMC and 71.2 ( 44.0–95.4 ) for CLAC ( P < .001 ) . The median ( range ) number of manual FIO2 adjustments was reduced from 77.0 ( 0.0–224.0 ) for RMC to 52.0 ( 10.0–317.0 ) for CLAC ( P = .007 ) . CONCLUSIONS : CLAC may improve oxygen administration to preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure while reducing workload related to RMC OBJECTIVE To determine the efficacy and safety of automated adjustment of the fraction of inspired oxygen ( FiO2 ) in maintaining arterial oxygen saturation ( SpO2 ) within a higher ( 91%-95 % ) and a lower ( 89%-93 % ) target range in preterm infants . STUDY DESIGN Eighty preterm infants ( gestational age [ median ] : 26 weeks , age [ median ] 18 days ) on noninvasive ( n = 50 ) and invasive ( n = 30 ) respiratory support with supplemental oxygen , were first r and omized to one of the SpO2 target ranges and then treated with automated FiO2 ( A-FiO2 ) and manual FiO2 ( M-FiO2 ) oxygen control for 24 hours each , in r and om sequence . RESULTS The percent time within the target range was higher during A-FiO2 compared with M-FiO2 control . This effect was more pronounced in the lower SpO2 target range ( 62 ± 17 % vs 54 ± 16 % , P < .001 ) than in the higher SpO2 target range ( 62 ± 17 % vs 58 ± 15 % , P < .001 ) . The percent time spent below the target or in hypoxemia ( SpO2 < 80 % ) was consistently reduced during A-FiO2 , independent of the target range . The time spent above the target range or at extreme hyperoxemia ( SpO2 > 98 % ) was only reduced during A-FiO2 when targeting the lower SpO2 range ( 89%-93 % ) . These outcomes did not differ between infants on noninvasive and invasive respiratory support . Manual adjustments were significantly reduced during A-FiO2 control . CONCLUSIONS A-FiO2 control improved SpO2 targeting across different SpO2 ranges and reduced hypoxemia in preterm infants on noninvasive and invasive respiratory support . TRIAL REGISTRATION IS RCT N 56626482 Objective To evaluate the performance of a novel rapidly responsive proportional-integral-derivative ( PID ) algorithm for automated oxygen control in preterm infants with respiratory insufficiency . Design Interventional study of a 4-hour period of automated oxygen control compared with combined data from two flanking periods of manual control ( 4 hours each ) . Setting Neonatal intensive care unit . Participants Preterm infants ( n=20 ) on non-invasive respiratory support and supplemental oxygen , with oxygen saturation ( SpO2 ) target range 90%–94 % ( manual control ) and 91%–95 % ( automated control ) . Median gestation at birth 27.5 weeks ( IQR 26–30 weeks ) , postnatal age 8.0 ( 1.8–34 ) days . Intervention Automated oxygen control using a st and alone device , receiving SpO2 input from a st and ard oximeter and computing alterations to oxygen concentration that were actuated with a modified blender . The PID algorithm was enhanced to avoid iatrogenic hyperoxaemia and adapt to the severity of lung dysfunction . Main outcome measure Proportion of time in the SpO2 target range , or above target range when in air . Results Automated oxygen control result ed in more time in the target range or above in air ( manual 56 (48–63)% vs automated 81 (76–90)% , p<0.001 ) and less time at both extremes of oxygenation . Prolonged episodes of hypoxaemia and hyperoxaemia were virtually eliminated . The control algorithm showed benefit in every infant . Manual changes to oxygen therapy were infrequent during automated control ( 0.24/hour vs 2.3/hour during manual control ) , and oxygen requirements were unchanged ( automated control period 27 % , manual 27 % and 26 % , p>0.05 ) . Conclusions The novel PID algorithm was very effective for automated oxygen control in preterm infants , and deserves further investigation OBJECTIVE : The goal was to reduce adverse pulmonary adverse outcomes , oxidative stress , and inflammation in neonates of 24 to 28 weeks of gestation initially resuscitated with fractions of inspired oxygen of 30 % or 90 % . METHODS : R and omized assignment to receive 30 % ( N = 37 ) or 90 % ( N = 41 ) oxygen was performed . Targeted oxygen saturation values were 75 % at 5 minutes and 85 % at 10 minutes . Blood oxidized glutathione (GSSG)/reduced glutathione ratio and urinary o-tyrosine , 8-oxo-dihydroxyguanosine , and isoprostane levels , isofuran elimination , and plasma interleukin 8 and tumor necrosis factor α levels were determined . RESULTS : The low-oxygen group needed fewer days of oxygen supplementation ( 6 vs 22 days ; P < .01 ) and fewer days of mechanical ventilation ( 13 vs 27 days ; P < .01 ) and had a lower incidence of bronchopulmonary dysplasia at discharge ( 15.4 % vs 31.7 % ; P < .05 ) . GSSG/reduced glutathione × 100 ratios at day 1 and 3 were significantly higher in the high-oxygen group ( day 1 : high-oxygen group : 13.36 ± 5.25 ; low-oxygen group : 8.46 ± 3.87 ; P < .01 ; day 3 : high-oxygen group : 8.87 ± 4.40 ; low-oxygen group : 6.97 ± 3.11 ; P < .05 ) . Urinary markers of oxidative stress were increased significantly in the high-oxygen group , compared with the low-oxygen group , in the first week after birth . GSSG levels on day 3 and urinary isofuran , o-tyrosine , and 8-hydroxy-2′-deoxyguanosine levels on day 7 were correlated significantly with development of chronic lung disease . CONCLUSIONS : Resuscitation of preterm neonates with 30 % oxygen causes less oxidative stress , inflammation , need for oxygen , and risk of bronchopulmonary dysplasia BACKGROUND Mechanically ventilated very low birth weight infants often present with frequent episodes of hypoxemia , and maintaining arterial oxygen saturation by pulse oximetry ( SpO(2 ) ) within a normal range by manual fraction \n Output:\n " }, { "from": "agent", "value": "Conclusion Automated FiO2 adjustment provides significant improvement of time in target saturations , reduces periods of hyperoxia , and severe hypoxia in preterm infants on positive pressure respiratory support" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aims /hypothesisObservational and mechanistic studies have suggested a possible relationship between treatment with metformin and decreased incidence of cancer in participants with type 2 diabetes . We extracted data for malignancies from the ADOPT ( A Diabetes Outcome Progression Trial ) and RECORD ( Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycaemia in Diabetes ) r and omised controlled clinical trials , in which the efficacy and /or safety of metformin was assessed in comparison with sulfonylureas and rosiglitazone . Methods Neoplasm occurrences were collected as adverse events in these studies . We review ed and re-analysed the individual participant data in both studies for serious adverse events , malignancies reported as adverse events and related neoplasms of special interest . Results In ADOPT , 50 participants ( 3.4 % ) on metformin and 55 ( 3.8 % ) on each of rosiglitazone and glibenclamide ( known as glyburide in the USA and Canada ) developed serious adverse event malignancies ( excluding non-melanoma skin cancers ) . This corresponds to 1.03 , 1.12 and 1.31 per 100 person-years , giving hazard ratios for metformin of 0.92 ( 95 % CI 0.63–1.35 ) vs rosiglitazone and 0.78 ( 0.53–1.14 ) vs glibenclamide . In RECORD , on a background of sulfonylurea , 69 ( 6.1 % ) participants developed malignant neoplasms in the metformin group , compared with 56 ( 5.1 % ) in the rosiglitazone group ( HR 1.22 [ 0.86–1.74 ] ) . On a background of metformin , 74 ( 6.7 % ) participants in the sulfonylurea group developed malignant neoplasms , compared with 57 ( 5.1 % ) in the rosiglitazone group ( HR 1.33 [ 0.94–1.88 ] ) . Conclusions /interpretationThe malignancy rates in these two r and omised controlled clinical trials do not support a view that metformin offers any particular protection against malignancy compared with rosiglitazone . However , they do not refute the possibility of a difference compared with sulfonylureas There is growing evidence that patients with type 2 diabetes mellitus have increased cancer risk . We examined the association between diabetes , cancer , and cancer-related mortality and hypothesized that insulin sensitizers lower cancer-related mortality . Participants in the Diabetes Cardiovascular Risk and Evaluation : Targets and Essential Data for Commitment of Treatment study , a nationwide cross-sectional and prospect i ve epidemiological study , were recruited from German primary care practice s. In the cross-sectional study , subjects with type 2 diabetes mellitus had a higher prevalence of malignancies ( 66/1308 , 5.1 % ) compared to nondiabetic subjects ( 185/6211 , 3.0 % ) ( odds ratio , 1.64 ; 95 % confidence interval , 1.12 - 2.41 ) before and after adjustment for age , sex , hemoglobin A(1c ) , smoking status , and body mass index . Patients on metformin had a lower prevalence of malignancies , comparable with that among nondiabetic patients , whereas those on any other oral combination treatment had a 2-fold higher risk for malignancies even after adjusting for possible confounders ; inclusion of metformin in these regimens decreased the prevalence of malignancies . In the prospect i ve analyses , diabetic patients in general and diabetic patients treated with insulin ( either as monotherapy or in combination with other treatments ) had a 2- and 4-fold , respectively , higher mortality rate than nondiabetic patients , even after adjustment for potential confounders ( incidence of cancer deaths in patients with type 2 diabetes mellitus [ 2.6 % ] vs the incidence of cancer deaths in patients without type 2 diabetes mellitus [ 1.2 % ] ) . Our results suggest that diabetes and medications for diabetes , with the exception of the insulin sensitizer metformin , increase cancer risk and mortality \n Output:\n " }, { "from": "agent", "value": "Conclusions Our findings demonstrate that use of metformin was significantly associated with a lower incidence and a better prognosis of ovarian cancer in patients with diabetes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIMS We examined the effects of physical activity with or without dietary restriction for 3 months on regional fat and insulin sensitivity and compared the effect of total energy expenditure from all levels of physical activity with that of physical activity energy expenditure from moderate-to-vigorous exercise in obese women with Type 2 diabetes . METHODS In this r and omized , controlled trial , we assessed change of body weight , abdominal visceral fat area , subcutaneous fat area and insulin sensitivity , expressed as K(ITT ) , and monitored total energy expenditure and physical activity energy expenditure using an accelerometer during a 12-week intervention in four groups : control , diet , exercise and diet plus exercise . RESULTS The mean body mass index was 28.0 + /- 2.7 kg/m(2 ) and the mean duration of diabetes was 8 + /- 6 years . Both the diet and diet plus exercise groups showed significant body weight loss compared with the control group ( P < 0.05 ) . However , the visceral fat area was reduced only in the diet and exercise group ( P = 0.017 ) and the subcutaneous fat area was reduced only in the diet group ( P = 0.009 ) . Mean energy intake was an independent determinant of the change in subcutaneous fat area ( P = 0.020 ) and mean total anergy expenditure was an independent determinant of visceral fat area ( P = 0.002 ) . Insulin sensitivity K(ITT ) was associated with physical activity energy expenditure ( P = 0.006 ) , energy intake ( P = 0.047 ) and the change in fructosamine level ( P = 0.016 ) but not with changes in body weight , subcutaneous fat area , visceral fat area or adipokine level . CONCLUSIONS Exercise had an additive effect to dietary restriction on visceral fat reduction . Visceral fat area was associated with total energy expenditure , but insulin sensitivity was associated with physical activity energy expenditure BACKGROUND Increased blood pressure ( BP ) in type 2 diabetes ( T2DM ) markedly increases cardiovascular disease morbidity and mortality risk compared to having increased BP alone . OBJECTIVE To investigate whether exercise reduces suboptimal levels of untreated suboptimal BP or treated hypertension . DESIGN Prospect i ve , r and omized controlled trial for 6 months . SETTING Single center in Baltimore , MD , USA . PATIENTS 140 participants with T2DM not requiring insulin and untreated SBP of 120–159 or DBP of 85–99 mmHg , or , if being treated for hypertension , any SBP < 159 mmHg or DBP < 99 mmHg ; 114 completed the study . INTERVENTIONS upervised exercise , 3 times per week for 6 months compared with general advice about physical activity . MEASUREMENTS Resting SBP and DBP ( primary outcome ) ; diabetes status , arterial stiffness assessed as carotid-femoral pulse-wave velocity ( PWV ) , body composition and fitness ( secondary outcomes ) . RESULTS Overall baseline BP was 126.8 ± 13.5 / 71.7 ± 9.0 mmHg , with no group differences . At 6 months , BP was unchanged from baseline in either group , BP 125.8 ± 13.2 / 70.7 ± 8.8 mmHg in controls ; and 126.0 ± 14.2 / 70.3 ± 9.0 mmHg in exercisers , despite attaining a training effects as evidence d by increased aerobic and strength fitness and lean mass and reduced fat mass ( all p < 0.05 ) , Overall baseline PWV was 959.9 ± 333.1 cm/s , with no group difference . At 6-months , PWV did not change and was not different between group ; exercisers , 923.7 ± 319.8 cm/s , 905.5 ± 344.7 , controls . LIMITATIONS A completion rate of 81 % . CONCLUSIONS Though exercisers improve fitness and body composition , there were no reductions in BP . The lack of change in arterial stiffness suggests a resistance to exercise-induced BP reduction in persons with T2DM OBJECTIVE To evaluate the feasibility of free-living walking training in type 2 diabetic patients and to investigate the effects of interval-walking training versus continuous-walking training upon physical fitness , body composition , and glycemic control . RESEARCH DESIGN AND METHODS Subjects with type 2 diabetes were r and omized to a control ( n = 8) , continuous-walking ( n = 12 ) , or interval-walking group ( n = 12 ) . Training groups were prescribed five sessions per week ( 60 min/session ) and were controlled with an accelerometer and a heart-rate monitor . Continuous walkers performed all training at moderate intensity , whereas interval walkers alternated 3-min repetitions at low and high intensity . Before and after the 4-month intervention , the following variables were measured : VO2max , body composition , and glycemic control ( fasting glucose , HbA1c , oral glucose tolerance test , and continuous glucose monitoring [ CGM ] ) . RESULTS Training adherence was high ( 89 ± 4 % ) , and training energy expenditure and mean intensity were comparable . VO2max increased 16.1 ± 3.7 % in the interval-walking group ( P < 0.05 ) , whereas no changes were observed in the continuous-walking or control group . Body mass and adiposity ( fat mass and visceral fat ) decreased in the interval-walking group only ( P < 0.05 ) . Glycemic control ( elevated mean CGM glucose levels and increased fasting insulin ) worsened in the control group ( P < 0.05 ) , whereas mean ( P = 0.05 ) and maximum ( P < 0.05 ) CGM glucose levels decreased in the interval-walking group . The continuous walkers showed no changes in glycemic control . CONCLUSIONS Free-living walking training is feasible in type 2 diabetic patients . Continuous walking offsets the deterioration in glycemia seen in the control group , and interval walking is superior to energy expenditure – matched continuous walking for improving physical fitness , body composition , and glycemic control This study examined the effects of aerobic exercise without weight loss , a hypocaloric high monounsaturated fat diet , and diet plus exercise ( D+E ) on total abdominal and visceral fat loss in obese postmenopausal women with type 2 diabetes . Thirty-three postmenopausal women ( body mass index , 34.6 + /- 1.9 kg/m(2 ) ) were assigned to one of three interventions : a hypocaloric high monounsaturated fat diet alone , exercise alone ( EX ) , and D+E for 14 wk . Aerobic capacity , body composition , abdominal fat distribution ( magnetic resonance imaging ) , glucose tolerance , and insulin sensitivity were measured pre- and postintervention . Body weight ( approximately 4.5 kg ) and percent body fat ( approximately 5 % ) were decreased ( P < 0.05 ) with the D and D+E intervention , whereas only percent body fat ( approximately 2.3 % ) decreased with EX . Total abdominal fat and sc adipose tissue ( SAT ) were reduced with the D and D+E interventions ( P < 0.05 ) , whereas visceral adipose tissue ( VAT ) decreased with the D+E and EX intervention , but not with the D intervention . EX result ed in a reduction in total abdominal fat , VAT , and SAT ( P < 0.05 ) despite the lack of weight loss . The reductions in total abdominal fat and SAT explained 32.7 % and 9.7 % , respectively , of the variability in the changes in fasting glucose levels , whereas the reductions in VAT explained 15.9 % of the changes in fasting insulin levels ( P < 0.05 ) . In conclusion , modest weight loss , through either D or D+E , result ed in similar improvements in total abdominal fat , SAT , and glycemic status in postmenopausal women with type 2 diabetes ; however , the addition of exercise to diet is necessary for VAT loss . These data demonstrate the importance of exercise in the treatment of women with type 2 diabetes OBJECTIVE To investigate the effect of an exercise intervention on flow-mediated dilation ( FMD ) and circulating endothelial biomarkers in adults with type 2 diabetes ( T2DM ) . METHODS Sedentary adults ( n = 140 ) , aged 40 - 65 , with T2DM and untreated pre or Stage I hypertension or treated hypertension were r and omized to a 6-month , supervised , exercise program ( 3 × week ) or a sedentary control . Assessment s included BMI , body and visceral fat , blood pressure , lipids , HbA1c , insulin sensitivity ( QUICKI ) , fitness , FMD , E-selectin , P-selectin , intracellular and vascular cellular adhesion molecules ( ICAM , VCAM ) , and tissue plasminogen activator ( tPA ) . Intervention effects were compared by t-tests . Pearson 's correlations were calculated between changes in cardiovascular risk factors and endothelial outcomes . RESULTS Exercisers significantly improved BMI ( -0.6 kg/m(2 ) ) , body fat % ( -1.4 % ) , HbA1c ( -0.5 % ) , and fitness ( 2.9 mL/kg min ) vs. controls ( p < 0.05 ) . However , there were no differences between groups in changes in FMD , E-selectin , P-selectin , ICAM , VCAM , or tPA . Among exercisers , changes in cardiovascular risk factors correlated with several biomarkers . Decreased P-selectin correlated with decreased BMI ( r = 0.29 , p = 0.04 ) and increased HDL cholesterol ( r = -0.36 , p = 0.01 ) . Decreased ICAM correlated with decreased triglycerides and HbA1c ( r = 0.30 , p = 0.04 ; r = 0.31 , p = 0.03 ) and increased QUICKI ( r = - 0.28 , p = 0.05 ) . Decreased tPA correlated with decreased total body and visceral fat ( r = 0.28 , p = 0.05 ; r = 0.38 , p = 0.008 ) and increased QUICKI ( r = -0.38 , p = 0.007 ) . CONCLUSIONS While exercise result ed in improved fitness , body composition , and glycemic control , there were no changes in FMD or circulating endothelial biomarkers . The associations of changes in cardiovascular risk factors and endothelial biomarkers suggest that improvement in risk factors could mediate the exercise-induced improvements in endothelial function seen in prior studies Background Our goal was to investigate the effects of low intensity resistance training on body fat , muscle mass and strength , cardiovascular fitness , and insulin sensitivity in type 2 diabetes . Methods Twenty-eight overweight women with type 2 diabetes were r and omly assigned to a resistance training group ( RG , n = 13 ) or a control group ( CG , n = 15 ) . RG performed resistance training using elastic b and s , of which strength was equal to 40 to 50 % of one repetition maximum ( 1RM ) , for three days per week . Each exercise consisted of three sets for 60 minutes . We assessed abdominal fat using computed tomography , muscle mass using dual-energy X-ray absorptiometry , and muscle strength using Keiser 's chest and leg press . Insulin sensitivity was measured using the insulin tolerance test , and aerobic capacity was expressed as oxygen uptake at the anaerobic threshold ( AT-VO2 ) before and after the 12-week exercise program . Results The age of participants was 56.4 ± 7.1 years , duration of diabetes was 5.9 ± 5.5 years , and BMI was 27.4 ± 2.5 kg/m2 , without significant differences between two groups . During intervention , a greater increase in muscle mass and greater decreases in both total fat mass and abdominal fat were observed in RG compared to those of CG ( P = 0.015 , P = 0.011 , P = 0.010 , respectively ) . Increase in 1RM of upper and lower extremities was observed in the RG ( P = 0.004 , P = 0.040 , respectively ) , without changes in AT-VO2 and insulin resistance in either group . Conclusion In conclusion , the low intensity resistance training was effective in increasing muscle mass and strength and reducing total fat mass without change of insulin sensitivity in type 2 diabetic patients Aims /hypothesisType 2 diabetes is regarded as inevitably progressive , with irreversible beta cell failure . The hypothesis was tested that both beta cell failure and insulin resistance can be reversed by dietary restriction of energy intake . Methods Eleven people with type 2 diabetes ( 49.5 ± 2.5 years , BMI 33.6 ± 1.2 kg/m2 , nine male and two female ) were studied before and after 1 , 4 and 8 weeks of a 2.5 MJ ( 600 kcal)/day diet . Basal hepatic glucose output , hepatic and peripheral insulin sensitivity and beta cell function were measured \n Output:\n " }, { "from": "agent", "value": "Aerobic exercise ( ES=-0.23 , 95 % CI : -0.44 to -0.03 ; P=0.025 ) but not resistance training exercise ( ES=-0.13 , 95 % CI : -0.37 to 0.12 ; P=0.307 ) was effective for reducing visceral fat in overweight/obese adults with type 2 diabetes .\nThese data suggest that exercise effectively reduces visceral and perhaps liver adipose tissue and that aerobic exercise should be a key feature of exercise programs aim ed at reducing visceral fat in obesity-related type 2 diabetes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES Joint hypermobility ( JH ) or \" ligamentous laxity \" is felt to be an underlying risk factor for many types of musculoskeletal presentation in paediatrics , and joint hypermobility syndrome ( JHS ) describes such disorders where symptoms become chronic , often more generalized and associated with functional impairment . Clinical features are felt to have much in common with more severe disorders , including Ehlers-Danlos syndrome ( EDS ) , osteogenesis imperfecta and Marfan syndrome , although this has not been formally studied in children . We defined the clinical characteristics of all patients with joint hypermobility-related presentations seen from 1999 to 2002 in a tertiary referral paediatric rheumatology unit . METHODS Patients were identified and recruited from paediatric rheumatology clinic and ward , and a dedicated paediatric rheumatology hypermobility clinic at Great Ormond Street Hospital . Data were collected retrospectively on the patients from the paediatric rheumatology clinics ( 1999 - 2002 ) and prospect ively on patients seen in the hypermobility clinic ( 2000 - 2002 ) . Specifically , historical details of developmental milestones , musculoskeletal or soft tissue diagnoses and symptoms , and significant past medical history were recorded . Examination features sought included measurements of joint and soft tissue laxity , and associated conditions such as scoliosis , dysmorphic features , cardiac murmurs and eye problems . RESULTS One hundred and twenty-five children ( 64 females ) were included on whom sufficient clinical data could be identified and who had clinical problems ascribed to JH present for longer than 3 months . Sixty-four were from the paediatric rheumatology clinic and 61 from the hypermobility clinic . No differences were found in any of the measures between the two population s and results are presented in a combined fashion . Three-quarters of referrals came from paediatricians and general practitioners but in only 10 % was hypermobility recognized as a possible cause of joint complaint . The average age at onset of symptoms was 6.2 yr and age at diagnosis 9.0 yr , indicating a 2- to 3-yr delay in diagnosis . The major presenting complaint was arthralgia in 74 % , abnormal gait in 10 % , apparent joint deformity in 10 % and back pain in 6 % . Mean age at first walking was 15.0 months ; 48 % were considered \" clumsy \" and 36 % as having poor coordination in early childhood . Twelve per cent had \" clicky \" hips at birth and 4 % actual congenital dislocatable hip . Urinary tract infections were present in 13 and 6 % of the female and male cases , respectively . Thirteen and 14 % , respectively , had speech and learning difficulties diagnosed . A history of recurrent joint sprains was seen in 20 % and actual subluxation/dislocation of joints in 10 % . Forty per cent had experienced problems with h and writing tasks , 48 % had major limitations of school-based physical education activities , 67 % other physical activities and 41 % had missed significant periods of schooling because of symptoms . Forty-three per cent described a history of easy bruising . Examination revealed that 94 % scored > or = 4/9 on the Beighton scale for generalized hypermobility , with knees ( 92 % ) , elbows ( 87 % ) , wrists ( 82 % ) , h and metacarpophalangeal joints ( 79 % ) , and ankles ( 75 % ) being most frequently involved . CONCLUSIONS JHS is poorly recognized in children with a long delay in the time to diagnosis . Although there is a referral bias towards joint symptoms , a surprisingly large proportion is associated with significant neuromuscular and motor development problems . Our patients with JHS also show many overlap features with genetic disorders such as EDS and Marfan syndrome . The delay in diagnosis results in poor control of pain and disruption of normal home life , schooling and physical activities . Knowledge of the diagnosis and simple interventions are likely to be highly effective in reducing the morbidity and cost to the health and social services In 30 healthy volunteers with clinical ly inconspicuous knee joints and nine patients with posttraumatic recurrent patella dislocation , the proprioceptive abilities of the knee joint were evaluated by an angle reproduction test . The results of the control goup showed no gender-or dominant-specific difference . The patient group showed a significant deterioration of proprioceptive capability in the injured knee joint . Even in the contralateral , uninjured knee joint , the angle reproduction test result was significantly reduced compared with the control group . After applying an elastic knee b and age , the control group and the patients with patella dislocation showed a significant improvement of the proprioceptive capability The objective of the present study is to compare and quantify the postural differences and joint pain distribution between subjects with benign joint hypermobility syndrome ( BJHS ) and the normal population . This observational , non-r and omized , and controlled study was conducted at Rheumatology and Physical Medicine and Rehabilitation Medicine Departments of a tertiary care teaching hospital . Subjects comprise 35 persons with diagnosis of BJHS , and the control group was matched for age and sex . Reedco ’s Posture score ( RPS ) and visual analogue scale ( VAS ) were the outcome measures . The subjects were assessed for pain in ten major joints and rated on a VAS . A st and ard posture assessment was conducted using the Reedco ’s Posture score . The same procedure was executed for an age- and sex-matched control group . Mean RPS for the BJHS group was 55.29 ± 8.15 and for the normal group it was 67 ± 11.94 . The most common postural deviances in subjects with BJHS were identified in the following areas of head , hip ( Sagittal plane ) , upper back , trunk , and lower back ( Coronal plane ) . Intensity of pain was found to be more in BJHS persons than that of the normal persons , and the knee joints were the most affected . The present study compared and quantified the postural abnormalities and the pain in BJHS persons . The need for postural re-education and specific assessment and training for the most affected joints are discussed . There is a significant difference in posture between subjects with BJHS and the normal population . BJHS persons need special attention to their posture re-education during physiotherapy sessions to reduce long-term detrimental effects on the musculoskeletal system We carried out a prospect i ve study to determine the validity of different sets of criteria to define the hypermobility syndrome ( HMS ) , as well as the frequency , reliability and clinical features of HMS items . All consecutive cases of HMS attending the rheumatological outpatient clinic of Hospital del Mar ( Barcelona , Spain ) constituted the index group ( n = 114 ) . A control group of non-HMS rheumatological patients ( n = 59 ) was r and omly selected to assess suitable cutoff points and particular HMS item prevalences . Beighton 's , Carter 's and Rotés ' HMS scores correlated very highly among them . Both the correlation coefficients obtained between each pair of sets of HMS criteria and the predictive efficiencies were uniformly high , suggesting high concurrent and predictive validity . All but 2 of the major items were more frequent among women . A basic set of criteria to define HMS is proposed . In relation to previous criteria the new scale shows better internal reliability and homogeneity . Results suggest that it may be suitable for screening studies and in clinical rheumatological setting OBJECTIVE To determine differences between hypermobile subjects and controls in terms of maximum strength , rate of force development , and balance . METHODS We recruited 13 subjects with hypermobility and 18 controls . Rate of force development and maximal voluntary contraction ( MVC ) during single leg knee extension of the right knee were measured isometrically for each subject . Balance was tested twice on a force plate with 15-second single-leg st and s on the right leg . Rate of force development ( N/second ) and MVC ( N ) were extracted from the force-time curve as maximal rate of force development (= limit Deltaforce/Deltatime ) and the absolute maximal value , respectively . RESULTS The hypermobile subjects showed a significantly higher value for rate of force development ( 15.2 % higher ; P = 0.038 , P = 0.453 , epsilon = 0.693 ) and rate of force development related to body weight ( 16.4 % higher ; P = 0.018 , P = 0.601 , epsilon = 0.834 ) than the controls . The groups did not differ significantly in MVC ( P = 0.767 , P = 0.136 , epsilon = 0.065 ) , and MVC related to body weight varied r and omly between the groups ( P = 0.921 , P = 0.050 , epsilon = 0.000 ) . In balance testing , the mediolateral sway of the hypermobile subjects showed significantly higher values ( 11.6 % higher ; P = 0.034 , P = 0.050 , epsilon = 0.000 ) than that of controls , but there was no significant difference ( 4.9 % difference ; P = 0.953 , P = 0.050 , epsilon = 0.000 ) in anteroposterior sway between the 2 groups . CONCLUSION Hypermobile women without acute symptoms or limitations in activities of daily life have a higher rate of force development in the knee extensors and a higher mediolateral sway than controls with normal joint mobility Quantification of dynamic balance is often necessary to assess a patient 's level of injury or ability to function in order to initiate an appropriate plan of care . Some therapists use the star-excursion test in an attempt to quantify dynamic balance . This test requires the patient to balance on one leg while reaching with the other leg . For the purpose of this study , the reach was performed in four directions . No previous research ers have attempted to evaluate the reliability of this test . Twenty healthy subjects between the ages of 18 and 35 years participated in this study . During two testing sessions , each subject was required to perform five reaching trials in four directions . Reliability estimates , calculated using the intraclass correlation coefficient ( 2 , 1 ) , ranged from 0.67 to 0.87 . Six duplicate practice sessions were suggested to increase this range above 0.86 . Task complexity may account for the moderate reliability estimates . Subjects should engage in a learning period before being evaluated on the star-excursion test \n Output:\n " }, { "from": "agent", "value": "To conclude , lower limb joint proprioception is reduced in those with BJHS compared to non-BJHS cohorts , whilst unclear in the upper limb" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Based on experimental and clinical evidence indicating that the anti-oxidant agent liposomal Cu/Zn superoxide dismutase ( Lipsod ) is an effective anti-inflammatory drug and possibly might be effective in reducing late radiation-induced tissue injury , a clinical trial using Lipsod to treat long-st and ing radiation-induced fibrosis ( RIF ) was begun at the Necker Hospital , Paris in May 1984 . Thirty-four patients presenting 42 distinct palpable zones of RIF involving the skin and underlying tissues were treated from May 1984 to January 1986 and followed for an average of 5 years ( range , 14 - 89 months ) . Lipsod was administered over 3 weeks in twice weekly i.m . injections of 5 mg for a total of 30 mg . Patients underwent two physical examinations by independent physicians at each check-up . Parameters noted included determination of the density of the palpated fibrotic block and the dimensions of the projected cutaneous surface . The extent of change in the fibrotic zone was expressed as the ratio of the sum of the dimensions ( L + W ) and the ratio of the uncorrected areas ( L x W ) of the projected cutaneous surface before and after treatment . Changes in density were noted and scored . All patients showed some clinical regression of fibrosis . In most patients , clinical ly assessable regression begun during the third week of treatment and was maximum by 2 months . The mean decreases in the linear dimensions ( L + W ) and in the area ( L x W ) of the projected cutaneous surface were 41 + /- 30 % and 57 + /- 26 % , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS PURPOSE Radiation-induced fibrosis ( RIF ) is a rare morbid complication of radiotherapy , without an established method of management . RIF treatment with a combination of pentoxifylline ( PTX ) and alpha-tocopherol ( vitamin E ; Vit E ) was recently prompted by the good results of a clinical trial and an animal study . The present double-blind , placebo-controlled , monocentric study was design ed to assess the efficacy of this combination in treating RIF sequelae . PATIENTS AND METHODS Twenty-four eligible women with 29 RIF areas involving the skin and underlying tissues were enrolled from December 1998 to April 2000 . These patients , previously irradiated for breast cancer , were r and omly assigned to four balanced treatment groups : ( A ) 800 mg/d of PTX and 1,000 U/d of Vit E ; ( B ) PTX plus placebo ; ( C ) placebo plus Vit E ; and ( D ) placebo-placebo . The main end point measure was the relative regression of measurable RIF surface after 6 months of treatment . Assessment was completed by depth ( with ultrasonography ) and associated symptom measures . RESULTS Twenty-two patients with 27 RIF areas were analyzed at 6 months . Mean RIF surface regression was significant with combined PTX/Vit E versus double placebo ( 60 % + /- 10 % v 43 % + /- 17 % ; P = .038 ) . The median slope for the speed of RIF surface area and volume regression was significantly higher for group A than groups B , C , and D. All treatments were well tolerated . CONCLUSION Six months ' treatment of combined PTX/Vit E can significantly reduce superficial RIF . Synergism between PTX and Vit E is likely , as treatment with each drug alone is ineffective , but these results require confirmation in larger series BACKGROUND / PURPOSE Quantitative measurement of skin biomechanical properties has been used effectively in the investigation of physiological changes in tissue structure and function and to determine treatment efficacy . As the methods are applied to new questions , tissue characteristics that may influence the result ant biomechanical properties are important considerations in the research design . For certain applications , variables such as dermal thickness and subdermal tissue composition , as well as age and /or solar exposure , may influence the skin biomechanics . METHODS We determined the influence of dermal thickness , tissue composition , and age on the skin biomechanical properties at the shoulder , thigh , and calf among 30 healthy females . We compared two devices , the Biomechanical Tissue Characterization System and the Cutometer SEM 575 Skin Elasticity Meter , to determine the effect of tissue sampling size . Dermal thickness was measured with 20 MHz ultrasound ( Dermascan C ) and tissue composition was inferred from anthropomorphic data . RESULTS Skin thickness was significantly correlated with stiffness , energy absorption , and U(r)/U(f ) for the shoulder . Body mass index ( BMI ) was significantly correlated with stiffness ( negative correlation ) , energy absorption ( positive ) , and skin thickness ( negative ) for the shoulder . Significant differences across body sites were observed . The calf was significantly different from the thigh and shoulders for all parameters ( P<0.05 , one-way anova ) . The calf had significantly lower laxity , laxity% , elastic deformation , energy absorption , elasticity , elasticity % , U(r ) , U(f ) , and U(r)/U(f ) and significantly higher stiffness compared with the thighs and shoulders . sites . The thigh and shoulder sites were significantly different for all parameters except U(r)/U(f ) , elasticity % , laxity% , and stiffness . The dominant and non-dominant sides were significantly different . The dominant side ( right for 90 % of the subjects ) had increased stiffness and decreased energy absorption ( tissue softness , compliance ) compared with the left side . A significant ( P < or = 0.02 ) negative relationship with age was seen for all biomechanical measures except stiffness at the shoulder . For the thigh and calf sites , significant negative correlations with age were found for elasticity % , U(r ) , and U(r)/U(f ) . Age and skin thickness were not correlated in this population . Skin thickness and age influenced the energy absorption at the shoulder site . The biological elasticity at the calf site could be predicted by age and BMI . The biological activity at the thigh site could be predicted by skin thickness and BMI . CONCLUSIONS Significant regional variations in biomechanical properties and dominant side effects were observed . The biomechanical properties were significantly influenced by age . Certain properties varied with dermal thickness and tissue composition . The parameters were well correlated between the two instruments . The Cutometer , with its smaller aperture , was found to be more sensitive to age relationships Intraoperative evaluation of skin flap viability has primarily been dependent on clinical judgment . The purpose of this study was to determine whether an orthogonal polarization spectral imaging device could be used to accurately predict viability of r and om-pattern skin flaps . Orthogonal polarization spectral imaging is a newly developed technique that visualizes the microcirculation using reflected light without the use of fluorescent dyes and allows for noninvasive real-time observation of functional microvascular networks . In Sprague-Dawley rats ( n = 24 ) , three types of r and om skin flaps were design ed with unknown zones of viability ( n = 8 per group ) . After flap elevation , the skin flaps were evaluated by both clinical examination and orthogonal polarization spectral imaging . Areas of the flap determined to be nonviable by clinical examination were measured and marked . Orthogonal polarization spectral imaging was subsequently performed , and areas of the skin flap with stasis ( i.e. , cessation of red blood cell movement ) in the dermal microcirculation on orthogonal polarization spectral imaging were measured and marked . The skin flaps were then secured in place . Flaps were evaluated on a daily basis for clinical signs of ischemia and necrosis . On postoperative day 7 , the total amount of r and om skin flap necrosis was measured and recorded . Clinical examination of the r and om skin flaps significantly underestimated the actual amount of eventual flap necrosis , and as result was a very poor predictor of flap necrosis . By contrast , assessment of microcirculatory stasis using the orthogonal polarization spectral imaging device correlated well with the subsequent development of necrosis in all groups . In the three groups , the average amount of flap necrosis predicted by clinical examination deviated from actual necrosis by approximately 2 to 4 cm . However , the amount that orthogonal polarization spectral imaging differed from actual necrosis was 0.1 to 0.3 cm . Therefore , orthogonal polarization spectral imaging was an excellent predictor of eventual flap necrosis and much more accurate than clinical observation ( p < 0.001 ) . Intraoperative evaluation of axial and r and om pattern flap viability has traditionally been based on clinical examination as no other reliable , convenient test currently exists . The authors demonstrated that an orthogonal polarization spectral imaging device accurately predicts zones of necrosis in r and om pattern flaps by directly visualizing cessation of microcirculatory flow . Intraoperative stasis in the dermal microcirculation correlated precisely with subsequent flap necrosis . Orthogonal polarization spectral imaging was significantly more accurate than clinical examination , which consistently underestimated flap necrosis . The orthogonal polarization spectral imaging technique may have value in the intraoperative assessment of skin flap perfusion such as that required after skin-sparing mastectomy PURPOSE Significant regression of radiation ( RT ) -induced fibrosis ( RIF ) has been achieved after treatment combining pentoxifylline ( PTX ) and alpha-tocopherol ( vitE ) . In this study , we focus on the maximum response , how long it takes to achieve response , and changes after treatment discontinuation . PATIENTS AND METHODS Measurable superficial RIF was assessed in patients treated by RT for breast cancer in a long-treatment ( 24 to 48 months ) PTX-vitE ( LPE ) group of 37 patients ( 47 RIFs ) and in a short-treatment ( 6 to 12 months ) PTX-vitE ( SPE ) group of seven patients ( eight RIFs ) . Between April 1995 and April 2000 , women were treated with a daily combination of PTX ( 800 mg ) and VitE ( 1,000 IU ) . RESULTS Combined PTX-vitE was continuously effective and result ed in exponential RIF surface area regression ( -46 % for LPE and -68 % for SPE at 6 months , -58 % for LPE and -69 % for SPE at 12 months , -63 % for LPE and -62 % for SPE at 18 months , and -68 % for LPE at 24 and 36 months ) . The mean estimated maximal treatment effect was 68 % RIF surface area regression . The mean time to this effect was 24 months and was shorter ( 16 months ) in more recent RIF ( < 6 years since RT ) than in older RIF ( 28 months ; P = .0003 ) . Symptom severity ( Subjective Objective Medical Management and Analytic Evaluation score ) was halved in both groups . After treatment discontinuation , mean RIF surface area at 1 year had increased by + 40 % in the SPE group ( rebound ) and + 8.5 % in the LPE group . CONCLUSION Under combined PTX-vitE treatment , RIF regression was exponential , with a two-thirds maximum response after a mean of 2 years . There was a risk of a rebound effect if treatment was too short . Long treatment ( > /= 3 years ) is recommended in patients with severe RIF This is the first report of an evaluation of the use of a laser Doppler imager ( LDI ) scanner in the assessment of burn depth in patients . It is based on a 6-month , prospect i ve audit of 76 burns of intermediate depth . Clinical and LDI assessment s of burn wound depth were recorded at 48 - 72 h post-injury . Histological confirmation of depth was obtained from those burns requiring surgery . A healing time of less than 21 days was taken as confirmation of the injury being an superficial dermal burn . The accuracy of LDI in the assessment of burn depth was 97 % , compared with 60 - 80 % for established clinical methods . This audit confirms that LDI is a very accurate measurement tool for the assessment of burn wound depth . We recommend that all burns of intermediate depth should be analysed in this way in order to ensure appropriate management of the burn , to avoid unnecessary surgery and to reduce hospital stay and costs OBJECTIVE Microcirculatory visualization has already been used to investigate buccal and cutaneous microcirculatory alterations in neonates . Still , the reproducibility of these microvascular measurements has never been studied in ( premature ) neonates . This study aim ed to determine the reproducibility of microvascular vessel density in cutaneous and buccal SDF clips in one-day-old term newborns . METHODS Buccal and cutaneous microcirculations were measured using SDF imaging . Vessel density was independently assessed by two investigators . Reproducibility was assessed from the ICC and Bl and -Altman analysis . RESULTS Reproducibility of vessel density assessment in the buccal area was good , with ICCs for total and PVD of 0.93 ( 0.88 - 0.97 ) and 0.93 ( 95 % CI 0.85 - 0.97 ) , respectively , and a near zero bias and acceptable limits of agreement in the Bl and -Altman analysis . Reproducibility of assessment of the cutaneous microcirculation was poor with ICCs for total and PVD of 0.31 ( 0 - 0.70 ) and 0.37 ( 0 - 0.74 ) , respectively , and large biases ( 3.09 and 2.53 ) in the Bl and -Altman analysis . CONCLUSIONS Evaluation of buccal microvascular vessel density in SDF-derived images in term newborns is reproducible in contrary to the cutaneous vessel density BACKGROUND Autologous fat grafting is increasingly used in reconstructive surgery . However , res \n Output:\n " }, { "from": "agent", "value": "Purified autologous fat grafts contain cellular and non-cellular properties that potentially interact with these processes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : To examine demographic , behavioral and dietary correlates of frequency of fast food restaurant use in a community-based sample of 891 adult women . DESIGN : A survey was administered at baseline and 3 y later as part of a r and omized , prospect i ve intervention trial on weight gain prevention . SUBJECTS : Women ( n=891 ) aged 20–45 y who enrolled in the Pound of Prevention study . MEASUREMENTS : Frequency of fast food restaurant use , dietary intake , demographic and behavioral measures were self-reported . Dietary intake was measured using the 60-item Block Food Frequency Question naire . Body weight and height were directly measured . RESULTS : Twenty-one percent of the sample reported eating ≥3 fast food meals per week . Frequency of fast food restaurant use was associated with higher total energy intake , higher percentage fat energy , more frequent consumption of hamburgers , French fries and soft drinks , and less frequent consumption of fiber and fruit . Frequency of fast food restaurant use was higher among younger women , those with lower income , non-White ethnicity , greater body weight , lower dietary restraint , fewer low-fat eating behaviors , and greater television viewing . Over 3 y , increases in frequency of fast food restaurant use were associated with increases in body weight , total energy intake , percentage fat intake , intake of hamburgers , French fries and soft drinks , and with decreases in physical activity , dietary restraint and low-fat eating behaviors . Intake of several other foods , including fruits and vegetables , did not differ by frequency of fast food restaurant use . CONCLUSION : Frequency of fast food restaurant use is associated with higher energy and fat intake and greater body weight , and could be an important risk factor for excess weight gain in the population 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 who did not complete the study were imputed . RESULTS The z score for the body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) increased on average by 0.02 SD units in the sugar-free group and by 0.15 SD units in the sugar group ; the 95 % confidence interval ( CI ) of the difference was -0.21 to -0.05 . Weight increased by 6.35 kg in the sugar-free group as compared with 7.37 kg in the sugar group ( 95 % CI for the difference , -1.54 to -0.48 ) . The skinfold-thickness measurements , waist-to-height ratio , and fat mass also increased significantly less in the sugar-free group . Adverse events were minor . When we combined measurements at 18 months in 136 children who had discontinued the study with those in 477 children who completed the study , the BMI z score increased by 0.06 SD units in the sugar-free group and by 0.12 SD units in the sugar group ( P=0.06 ) . CONCLUSIONS Masked replacement of sugar-containing beverages with noncaloric beverages reduced weight gain and fat accumulation in normal-weight children . ( Funded by the Netherl and s Organization for Health Research and Development and others ; DRINK Clinical Trials.gov number , NCT00893529 . ) BACKGROUND Increased intake of sugar-sweetened beverages and fruit juice has been associated with overweight in children . OBJECTIVE This study prospect ively assessed beverage consumption patterns and their relationship with weight status in a cohort of children born at different risk for obesity . METHODS AND PROCEDURES Participants were children born at low risk ( n = 27 ) or high risk ( n = 22 ) for obesity based on maternal prepregnancy BMI ( kg/m(2 ) ) . Daily beverage consumption was generated from 3-day food records from children aged 3 - 6 years and coded into seven beverage categories ( milk , fruit juice , fruit drinks , caloric and non-caloric soda , soft drinks including and excluding fruit juice ) . Child anthropometric measures were assessed yearly . RESULTS High-risk children consumed a greater percentage of daily calories from beverages at age 3 , more fruit juice at ages 3 and 4 , more soft drinks ( including fruit juice ) at ages 3 - 5 , and more soda at age 6 compared to low-risk children . Longitudinal analyses showed that a greater 3-year increase in soda intake was associated with an increased change in waist circumference , whereas a greater increase in milk intake was associated with a reduced change in waist circumference . There was no significant association between change in intake from any of the beverage categories and change in BMI z-score across analyses . DISCUSSION Children 's familial predisposition to obesity may differentially affect their beverage consumption patterns . Future research should examine the extent to which dietary factors may play a role in pediatric body fat deposition over time Background — Sugar-sweetened beverage consumption is associated with weight gain and risk of type 2 diabetes mellitus . Few studies have tested for a relationship with coronary heart disease ( CHD ) or intermediate biomarkers . The role of artificially sweetened beverages is also unclear . Methods and Results — We performed an analysis of the Health Professionals Follow-Up Study , a prospect i ve cohort study including 42 883 men . Associations of cumulatively averaged sugar-sweetened ( eg , sodas ) and artificially sweetened ( eg , diet sodas ) beverage intake with incident fatal and nonfatal CHD ( myocardial infa rct ion ) were examined with proportional hazard models . There were 3683 CHD cases over 22 years of follow-up . Participants in the top quartile of sugar-sweetened beverage intake had a 20 % higher relative risk of CHD than those in the bottom quartile ( relative risk=1.20 ; 95 % confidence interval , 1.09–1.33 ; P for trend < 0.01 ) after adjustment for age , smoking , physical activity , alcohol , multivitamins , family history , diet quality , energy intake , body mass index , pre-enrollment weight change , and dieting . Artificially sweetened beverage consumption was not significantly associated with CHD ( multivariate relative risk=1.02 ; 95 % confidence interval , 0.93–1.12 ; P for trend=0.28 ) . Adjustment for self-reported high cholesterol , high triglycerides , high blood pressure , and diagnosed type 2 diabetes mellitus slightly attenuated these associations . Intake of sugar-sweetened but not artificially sweetened beverages was significantly associated with increased plasma triglycerides , C-reactive protein , interleukin-6 , and tumor necrosis factor receptors 1 and 2 and decreased high-density lipoprotein , lipoprotein(a ) , and leptin ( P<0.02 ) . Conclusions — Consumption of sugar-sweetened beverages was associated with increased risk of CHD and some adverse changes in lipids , inflammatory factors , and leptin . Artificially sweetened beverage intake was not associated with CHD risk or biomarkers BACKGROUND During the nutrition transition in Chile , dietary changes were marked by increased consumption of high-energy , nutrient-poor products , including sugar-sweetened beverages ( SSBs ) . Obesity is now the primary nutritional problem in posttransitional Chile . OBJECTIVE We conducted a r and omized controlled trial to examine the effects on body composition of delivering milk beverages to the homes of overweight and obese children to displace SSBs . DESIGN We r and omly assigned 98 children aged 8 - 10 y who regularly consumed SSBs to intervention and control groups . During a 16-wk intervention , children were instructed to drink 3 servings/d ( approximately 200 g per serving ) of the milk delivered to their homes and to not consume SSBs . Body composition was measured by dual-energy X-ray absorptiometry . Data were analyzed by multiple regression analysis according to the intention-to-treat principle . RESULTS For the intervention group , milk consumption increased by a mean ( + /- SEM ) of 452.5 + /- 37.7 g/d ( P < 0.0001 ) , and consumption of SSBs decreased by -711.0 + /- 33.7 g/d ( P < 0.0001 ) . For the control group , milk consumption did not change , and consumption of SSBs increased by 71.9 + /- 33.6 g/d ( P = 0.04 ) . Changes in percentage body fat , the primary endpoint , did not differ between groups . Nevertheless , the mean ( + /- SE ) accretion of lean body mass was greater ( P = 0.04 ) in the intervention ( 0.92 + /- 0.10 kg ) than in the control ( 0.62 + /- 0.11 kg ) group . The increase in height was also greater ( P = 0.01 ) in the intervention group ( 2.50 + /- 0.21 cm ) than in the control group ( 1.77 + /- 0.20 cm ) for boys but not for girls . CONCLUSION Replacing habitual consumption of SSBs with milk may have beneficial effects on lean body mass and growth in children , despite no changes in percentage body fat . This trial was registered at clinical trials.gov as NCT00149695 This study examined the effect of food group intake on subsequent 2-y weight change . Food-frequency question naire-based food intake data of 17,369 nonsmoking subjects of the European Prospect i ve Investigation into Cancer and Nutrition (EPIC)-Potsdam cohort were examined in their relation to a subsequent weight change . Dietary data , collected from 1994 to 1998 , were grouped into 24 food groups . Weight change per year follow-up was the outcome of interest ; large weight gain was defined as > or = 2 kg ; small weight gain as > or = 1 kg to < 2 kg ; large weight loss as < or = -2 kg ; small weight loss as < or = -1 kg to > -2 kg and weight maintenance as + /- 1 kg . For each food group , a separate polytomous logistic regression model with stable weight as the reference group was constructed , controlling for age , body mass index , previous weight change , and behavioral and lifestyle factors . Odds ratios ( OR ) and 95 % confidence intervals ( CI ) estimated the increase in risk associated with each 100 g/d increment in food group intake . In women , consumption of high energy , high fat food groups significantly predicted large weight gain , e.g. , fats ( OR = 1.75 ; 95 % CI , 1.01 - 3.06 ) , sauces ( OR = 2.12 ; 95 % CI , 1.17 - 3.82 ) and meat ( OR = 1.36 ; 95 % CI , 1.04 - 1.79 ) , and the consumption of cereals predicted large weight loss ( OR = 1.43 ; 95 % CI , 1.09 - 1.8 \n Output:\n " }, { "from": "agent", "value": "Establishing field st and ards in the study of SSB intake and health outcomes would facilitate interpretation across research studies and thereby increase the utility of systematic review s/meta-analyses and ultimately the efficiency of research efforts ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: 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 OBJECTIVE This study tested the efficacy of an 8-week culturally targeted nutrition and physical activity intervention on body composition . METHODS A r and omized , attention-controlled , two-group trial was conducted in a blackowned commercial gym with a sample of 366 predominantly healthy , obese African American women . A free 1-year membership to the study site gym was provided to participants in both groups . Data were collected at baseline , 2 , 6 , and 12 months . RESULTS Sample retention at 1 year was 71 % . Between-group longitudinal analysis including only participants with complete data revealed a trend toward weight stability in the intervention group at 2 months compared with controls ( + 0.05 kg/m(2 ) , p = 0.75 ; + 0.32 kg/m(2 ) , p = 0.08 , respectively ) , disappearing at 12 months ( + 1.37 kg/m(2 ) , p = 0.0001 ; + 1.02 kg/m(2 ) , p = 0.001 , respectively ) . Within-group analysis demonstrated that intervention and control participants ' fitness ( 1-mile run-walk ) improved by 1.9 minutes ( p = 0.0001 ) and 2.3 minutes ( p = 0.0001 ) , respectively , at 12 months . Mixed model regression analyses demonstrated a significant main effect of the intervention on fitness ( p = 0.0185 ) and a marginally significant effect on body mass index ( BMI ) ( p = 0.057 ) , at 2 months , disappearing by 6 months . By 12 months , however , the controls exhibited a significant advantage in waist circumference stability compared with intervention participants ( + 1.1 cm , p = 0.2763 ; + 2.1 cm , p = 0.0002 , respectively ) . CONCLUSIONS The intervention produced modest short-term improvements in body composition , but the economic incentive of a free 1-year gym membership provided to all participants was a more potent intervention than the education and social support intervention tested . However , longer-term fitness enhancement remains elusive and dem and s research and policy attention . These findings have policy implication s in that employer-/insurer-subsidized gym memberships may require interventions targeting other levels of change ( e.g. , physical or social/environmental ) to foster sustainable fitness improvements The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice Background Latinos comprise the largest racial/ethnic group in the United States and have 2–3 times the prevalence of type 2 diabetes mellitus as Caucasians . Methods and design The Lawrence Latino Diabetes Prevention Project ( LLDPP ) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a ≥ 30 % probability of developing diabetes in the next 7.5 years per a predictive equation . The project was conducted in Lawrence , Massachusetts , a predominantly Caribbean-origin urban Latino community . Individuals were identified primarily from a community health center 's patient panel , screened for study eligibility , r and omized to either a usual care or a lifestyle intervention condition , and followed for one year . Like the efficacious Diabetes Prevention Program ( DPP ) , the LLDPP intervention targeted weight loss through dietary change and increased physical activity . However , unlike the DPP , the LLDPP intervention was less intensive , tailored to literacy needs and cultural preferences , and delivered in Spanish . The group format of the intervention ( 13 group sessions over 1 year ) was complemented by 3 individual home visits and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist . Study measures included demographics , Stern predictive equation components ( age , gender , ethnicity , fasting glucose , systolic blood pressure , HDL-cholesterol , body mass index , and family history of diabetes ) , glycosylated hemoglobin , dietary intake , physical activity , depressive symptoms , social support , quality of life , and medication use . Body weight was measured at baseline , 6-months , and one-year ; all other measures were assessed at baseline and one-year . All surveys were orally administered in Spanish . Results A community-academic partnership enabled the successful recruitment , intervention , and assessment of Latinos at risk of diabetes with a one-year study retention rate of 93%.Trial registration BACKGROUND Many patients in primary care setting s present with multiple behavioral risk factors for cardiovascular disease . Research has provided little information on the most effective ways to approach multiple behavior change counseling in clinical setting s. METHODS We implemented a r and omized trial in a publicly funded primary care setting to test whether a sequential presentation of stage of change-based counseling to stop smoking , reduce dietary sodium level to less than 100 mEq/L per day , and increase physical activity by at least 10,000 pedometer steps per week would be more effective than simultaneous counseling . African Americans with hypertension , aged 45 to 64 years , initially nonadherent to the 3 behavioral goals , were r and omized to the following conditions : ( 1 ) 1 in-clinic counseling session on all 3 behaviors every 6 months , supplemented by motivational interviewing by telephone for 18 months ; ( 2 ) a similar protocol that addressed a new behavior every 6 months ; or ( 3 ) 1-time referral to existing group classes ( \" usual care \" ) . The primary end point was the proportion in each arm that met at least 2 behavioral criteria after 18 months . RESULTS A total of 289 individuals ( 67.3 % female ) were r and omized , and 230 ( 79.6 % ) completed the study . At 18 months , only 6.5 % in the simultaneous arm , 5.2 % in the sequential arm , and 6.5 % in the usual-care arm met the primary end point . However , results for single behavioral goals consistently favored the simultaneous group . At 6 months , 29.6 % in the simultaneous , 16.5 % in the sequential , and 13.4 % in the usual-care arms had reached the urine sodium goal ( P = .01 ) . At 18 months , 20.3 % in the simultaneous , 16.9 % in the sequential , and 10.1 % in the usual-care arms were urine cotinine negative ( P = .08 ) . CONCLUSIONS Long-term multiple behavior change is difficult in primary care . This study provides strong evidence that addressing multiple behaviors sequentially is not superior to , and may be inferior to , a simultaneous approach Background The purpose of this study was to demonstrate how formative program process evaluation was used to improve dose and fidelity of implementation , as well as reach of the intervention into the target population , in the \" Active by Choice Today \" ( ACT ) r and omized school-based trial from years 1 to 3 of implementation . Methods The intervention integrated constructs from Self-Determination Theory and Social Cognitive Theory to enhance intrinsic motivation and behavioral skills for increasing long-term physical activity ( PA ) behavior in underserved adolescents ( low income , minorities ) . ACT formative process data were examined at the end of each year to provide timely , corrective feedback to keep the intervention \" on track \" . Results Between years 1 and 2 and years 2 and 3 , three significant changes were made to attempt to increase dose and fidelity rates in the program delivery and participant attendance ( reach ) . These changes included exp and ing the staff training , reformatting the intervention manual , and developing a tracking system for contacting parents of students who were not attending the after-school programs regularly . Process outcomes suggest that these efforts result ed in notable improvements in attendance , dose , and fidelity of intervention implementation from years 1 to 2 and 2 to 3 of the ACT trial . Conclusion Process evaluation methods , particularly implementation monitoring , are useful tools to ensure fidelity in intervention trials and for identifying key best practice s for intervention delivery OBJECTIVE To assess the feasibility , acceptability , and outcomes of 2 versions of a culturally relevant , family-based intervention to prevent excess weight gain in pre-adolescent African-American girls . DESIGN Three-arm , 12-week parallel group r and omized controlled pilot trial . SETTING Community centers in Memphis , Tennessee . PARTICIPANTS Sixty African-American girls , aged 8 to 10 years , with a body mass index ( BMI ) > or = 25th percentile of the CDC growth charts , along with their parents/caregivers . INTERVENTIONS The active interventions involved highly interactive weekly group sessions with either girls ( child-targeted program ) or parents/caregivers ( parent-targeted program ) . Content focused on knowledge and behavior change skills to promote healthy eating and increased physical activity . The comparison intervention focused on global self-esteem . MAIN OUTCOME MEASURES Given the lack of power and the limited time frame of the pilot study , outcomes were evaluated on the basis of implementation measures and changes in physical activity ( accelerometer data ) , and in consumption of sweetened beverages and water , as estimated from question naires . Changes in body mass index , waist circumference , and body composition were also examined . RESULTS The Memphis GEMS pilot intervention met all recruitment , retention , implementation , and participation goals , and was given high rating by both participants and interventionists . With respect to the comparison intervention , girls in both the child-targeted and parent-targeted interventions demonstrated a trend toward reduced body mass index and waist circumference . In addition , girls in the active intervention groups reduced their consumption of sweetened beverages by 34 % , increased their level of moderate-to-vigorous activity by 12 % , and increased their serving ; of water by 1.5 % . CONCLUSIONS The findings from this pilot study demonstrated the feasibility , perceived acceptability , and efficacy of culturally relevant , obesity prevention interventions for pre-adolescent African-American girls and their parents/caregivers BACKGROUND Prevention efforts to reduce the morbidity and mortality disparity between blacks and whites in the United States present a national health priority . However , participation of blacks in prevention trials has been low . The present study reports successful recruitment processes from two economically diverse black population s. METHODS The two studies were independent projects , but both were part of a nationally funded collaboration on cardiovascular health . \" Hip Hop to Health \" is a 4-year r and omized controlled trial aim ed at di \n Output:\n " }, { "from": "agent", "value": "Successful retention strategies included efficient administrative tracking of participants , persistence , skillful teamwork , and demonstrating a positive , caring attitude towards participants ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Compression anastomotic ring-locking procedure ( CARP ) is a novel procedure for creating colonic anastomoses . The surgical procedure allows perioperative quantification of the compression pressure between the intestinal ends within the anastomosis and postoperative monitoring of the anastomotic integrity . We have recently shown that CARP is a safe and effective method for colonic anastomoses in pigs , and the purpose of the present study was to evaluate CARP for colonic anastomoses in humans . Material s and methods This is a prospect i ve study on 25 patients undergoing elective left-sided colonic resection . Time for evacuation of the anastomotic rings , perioperative compression pressure , and adverse effects were recorded . Postoperative blood sample s were collected daily , and flexible sigmoidoscopy was performed 8–12 weeks after surgery to examine the anastomoses . Results Fourteen out of 25 patients underwent CARP . CARP was not used in 11 patients due to advanced tumor disease ( two cases ) and size restrictions ( nine cases ) . No case of anastomotic leakage , bowel obstruction , or stenosis formation was observed . No device-related perioperative adverse events were noted . The surgical device evacuated spontaneously in all patients by the natural route after a median of 10 days . Perioperative compression pressure ranged between 85 and 280 mBar ( median 130 mBar ) . Flexible sigmoidoscopy revealed smooth anastomoses without signs of pathological inflammation or stenosis in all cases . Conclusion Our results indicate that the novel suture-less CARP is a safe and effective method for creating colonic anastomoses . Further studies are warranted in larger patient population s to compare CARP head-on-head with stapled and /or h and -sewn colonic anastomoses The purpose of this study was to determine whether the characteristics of compression anastomoses created by a new device are comparable to existing stapler technology . A total of 18 pigs were studied , and each served as its own control using a 27-mm compression device and a 29-mm stapler . Anastomoses were r and omized to proximal and distal positions along the rectum and were separated by 10 cm . Six nonsurvival pigs were sacrificed at zero time to failure test the anastomoses . Twelve pigs were sacrificed at 14 days . Failure pressures , circumferences , and radiographic leak rates were determined . Anastomotic tissue was processed for matrix metalloproteinase , collagen , and elastin levels . The compression anastomoses had higher mean failure pressures than stapled anastomoses at zero time ( 103 vs 29.9 mm Hg ) . At 2 weeks , there was no difference between failure pressures ( 256 vs 250 mm Hg ) . During burst testing , 3 of the compression anastomoses failed at the anastomosis at 2 weeks , whereas none of the stapled anastomoses failed . The mean anastomotic circumference of the compression anastomoses was narrower than the stapled anastomoses ( 9.63 vs 11.25 cm , P = .001 ) . There were no clinical leaks or radiographic leaks by barium enema at 2 weeks . There was no difference between matrix metalloproteinase , collagen , or elastin content based on tissue analysis . There were dense adhesions to 7 of 12 ( 58.3 % ) of the stapled anastomoses , whereas only 1 of 12 ( 8.3 % ) of the compression anastomoses had flimsy adhesions . A new compression anastomosis technique using a nickel-titanium alloy may be an advance in technology by reducing leaks and eliminating foreign material in the anastomosis CONTEXT Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected , but direct evidence of such bias is currently limited to case reports . OBJECTIVE To study empirically the extent and nature of outcome reporting bias in a cohort of r and omized trials . DESIGN Cohort study using protocol s and published reports of r and omized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg , Denmark , in 1994 - 1995 . The number and characteristics of reported and unreported trial outcomes were recorded from protocol s , journal articles , and a survey of trialists . An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta- analysis . Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias . Protocol s and published articles were also compared to identify discrepancies in primary outcomes . MAIN OUTCOME MEASURES Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes ; consistency between primary outcomes defined in the most recent protocol s and those defined in published articles . RESULTS One hundred two trials with 122 published journal articles and 3736 outcomes were identified . Overall , 50 % of efficacy and 65 % of harm outcomes per trial were incompletely reported . Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy ( pooled odds ratio , 2.4 ; 95 % confidence interval [ CI ] , 1.4 - 4.0 ) and harm ( pooled odds ratio , 4.7 ; 95 % CI , 1.8 - 12.0 ) data . In comparing published articles with protocol s , 62 % of trials had at least 1 primary outcome that was changed , introduced , or omitted . Eighty-six percent of survey responders ( 42/49 ) denied the existence of unreported outcomes despite clear evidence to the contrary . CONCLUSIONS The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocol s. Published articles , as well as review s that incorporate them , may therefore be unreliable and overestimate the benefits of an intervention . To ensure transparency , planned trials should be registered and protocol s should be made publicly available prior to trial completion Background Shape-memory compression bowel anastomosis using a nickel and titanium alloy may reduce leak rates and eliminate foreign anastomotic material . Its safety and efficacy had been demonstrated by animal studies . We conducted the first prospect i ve multi-center clinical evaluation of the safety and effectiveness of BioDynamix anastomosis with ColonRing ™ for large-bowel end-to-end or side-to-end anastomosis . Material s and methods The ColonRing ™ was compared to the st and ard double-stapled colorectal/colocolonic anastomosis . Intraoperative and immediate postoperative and 1- and 3-month postoperative follow-up data were recorded . Results Ten study patients ( four males , median age 62 years , range 35–75 ) were compared to 13 demographically matched controls ( six males , median age 62 years , range 47–82 ) . Colorectal neoplasia was the most frequent indication for surgery ( 21/23 patients , 91 % ) . The median anastomotic distance from the anal verge for both groups was 10 cm ( 6–20 cm ) . The first postoperative bowel movement was on day 5 ±2.2 ( study group ) and on day 4 ±1.8 ( controls ) , and the median hospital stay was 8 days ( 6–14 days ) and 7 days ( 6–13 days ) , respectively . There were no anastomotic leaks . There were three minor complications in each group , unrelated to the device in the study group . Two patients required transanal digital extraction of the ring which was detached but not expelled ( one had a soft anastomotic stricture ) . Conclusions Our preliminary results in this first study on humans indicate that the safety and efficacy of BioDynamix anastomosis with ColonRing ™ in colorectal anastomosis in human is comparable to st and ard staples technology and warrant larger studies for further validation The recent development of a compression device using shape memory Nitinol technogy to create an end‐to‐end anastomosis has renewed the interest in sutureless anastomotic techniques . A phase II , prospect i ve open label clinical trial was started in May 2007 to evaluate the feasibility and safety of this new anastomotic device . Fourty patients who need left colectomy or high anterior resection for either diverticular disease or adenocarcinoma will be recruited in two academic hospitals ( Uppsala , Sweden and Leuven , Belgium ) . Clinical leakage is the primary endpoint . Only preliminary results are available to date as the recruitment is ongoing . The median age of the first ten patients is 57.5 years ( 44–72 ) . No anastomotic leakage occurred . The median hospital stay was 4.0 days . Only three patients noticed the passage of the ring through the anal canal . By three weeks no ring was sustained in the gastrointestinal tract as was objectified by plain X‐ray . First clinical use of this new anastomotic device seems promising . Final results for the total phase II trial are awaited . A prospect i ve r and omized trial to compare the efficacy of the EndoCar 28 with conventional stapling should be the next step Purpose The present study was performed to get a better insight in the incidence of anastomotic leakage leading to reintervention when using the C-seal : a biodegradable sheath that protects the stapled colorectal anastomosis from leakage . Methods The C-seal is a thin walled tube-like sheath that forms a protective sheath within the bowel lumen . Thirty-seven patients undergoing surgery with creation of a stapled colorectal anastomosis with C-seal were analyzed . Follow-up was completed until 3 months after surgery . Results One patient ( 3 % ) developed anastomotic leakage leading to reintervention . None of the 37 anastomoses was dismantled . One patient was diagnosed with a rectovaginal fistula . In three patients ( 8 % ) , a perianastomotic abscess spontaneously drained . Conclusion The incidence of anastomotic leakage leading to reintervention when using the C-seal ( 3 % ) is lower than expected based on the literature ( 11 % ) . We have currently set-up a multicenter r and omized trial to confirm the efficiency of the C-seal ( www.csealtrial.nl ) Objective : The purpose of this study was to identify patient , clinical , and surgical factors that may predispose patients to anastomotic leak ( AL ) after large bowel surgery . Background : Anastomotic leak is still one of the most devastating complications following colorectal surgery . Knowledge about factors predisposing patients to AL is vital to its early detection , decision making for surgical time , managing preoperative risk factors , and postoperative complications . Methods : This was a prospect i ve observational , quality improvement study in a cohort of 616 patients undergoing colorectal resection in a single institution with the main outcome being AL within 30 days postoperatively . Some of the predictor variables were age , sex , Charlson Comorbidity Index ( CCI ) , radiation and chemotherapy , immunomodulator medications , albumin , preoperative diagnoses , surgical procedure(s ) , surgical technique ( laparoscopic vs open ) , anastomotic technique ( staple vs h and sewn ) , number of major arteries ligated at surgery , surgeon 's experience , presence of infectious condition at surgery , intraoperative adverse events , and functional status using 36-Item Short Form General Health Survey . Results : Of the 616 patients , 53.4 % were female . The median age of the patients was 63 years and the mean body mass index was 25.9 kg/m2 . Of them , 80.3 % patients had laparoscopic surgery and 19.5 % had open surgery . AL occurred in 5.7 % ( 35 ) patients . In multivariate analysis , significant independent predictors for leak were anastomoses less than 10 cm from the anal verge , CCI of 3 or more , high inferior mesenteric artery ligation ( above left colic artery ) , intraoperative complications , and being of the male sex . Conclusions : Multiple risk factors exist that predispose patients to ALs . These risk factors should be considered before and during the surgical care of colorectal patients Objective To analyze total mesorectal excision ( TME ) for rectal cancer by the laparoscopic approach during a prospect i ve nonr and omized trial . Summary Background Data Improved local control and survival rates in the treatment of rectal cancer have been reported after TME . Methods The authors conducted a prospect i ve consecutive series of 100 laparoscopic TMEs for low and mid-rectal tumors . All patients had a sphincter-saving procedure . Case selection , surgical technique , and clinical and oncologic results were review ed . Results The distal limit of rectal neoplasm was on average 6.1 ( range 3–12 ) cm from the anal verge . The mean operative time was 250 ( range 110–540 ) minutes . The conversion rate was 12 % . Excluding the patient who stayed 104 days after a severe fistula and reoperation , the mean postoperative stay was 12.05 ( range 5–53 ) days . The 30-day mortality was 2 % and the overall postoperative morbidity was 36 % , including 17 anastomotic leaks . Of 87 malignant cases , 70 ( 80.4 % ) had a minimum follow-up of 12 months , with a median follow-up of 45.7 ( range 12–72 ) months . During this period 18.5 % ( 13/70 ) died of cancer and 8.5 % ( 6/70 ) are alive with metastatic disease . The port-site metastasis rate was 1.4 % ( 1/70 ) : a rectal cancer \n Output:\n " }, { "from": "agent", "value": "There were no statistically significant differences between compression and conventional anastomoses in any of the secondary outcomes .\nThis review was unable to demonstrate any statistically significant differences in favor of the compression anastomosis technique over conventional manual or stapled mechanical anastomoses" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Mortality in people in Africa with HIV infection starting antiretroviral therapy ( ART ) is high , particularly in those with advanced disease . We assessed the effect of a short period of community support to supplement clinic-based services combined with serum cryptococcal antigen screening . METHODS We did an open-label , r and omised controlled trial in six urban clinics in Dar es Salaam , Tanzania , and Lusaka , Zambia . From February , 2012 , we enrolled eligible individuals with HIV infection ( age ≥18 years , CD4 count of < 200 cells per μL , ART naive ) and r and omly assigned them to either the st and ard clinic-based care supplemented with community support or st and ard clinic-based care alone , stratified by country and clinic , in permuted block sizes of ten . Clinic plus community support consisted of screening for serum cryptococcal antigen combined with antifungal therapy for patients testing antigen positive , weekly home visits for the first 4 weeks on ART by lay workers to provide support , and in Tanzania alone , re-screening for tuberculosis at 6 - 8 weeks after ART initiation . The primary endpoint was all-cause mortality at 12 months , analysed by intention to treat . This trial is registered with the International St and ard R and omised Controlled Trial Number registry , number ISCRTN 20410413 . FINDINGS Between Feb 9 , 2012 , and Sept 30 , 2013 , 1001 patients were r and omly assigned to clinic plus community support and 998 to st and ard care . 89 ( 9 % ) of 1001 participants in the clinic plus community support group did not receive their assigned intervention , and 11 ( 1 % ) of 998 participants in the st and ard care group received a home visit or a cryptococcal antigen screen rather than only st and ard care . At 12 months , 25 ( 2 % ) of 1001 participants in the clinic plus community support group and 24 ( 2 % ) of 998 participants in the st and ard care group had been lost to follow-up , and were censored at their last visit for the primary analysis . At 12 months , 134 ( 13 % ) of 1001 participants in the clinic plus community support group had died compared with 180 ( 18 % ) of 998 in the st and ard care group . Mortality was 28 % ( 95 % CI 10 - 43 ) lower in the clinic plus community support group than in st and ard care group ( p=0·004 ) . INTERPRETATION Screening and pre-emptive treatment for cryptococcal infection combined with a short initial period of adherence support after initiation of ART could substantially reduce mortality in HIV programmes in Africa . FUNDING European and Developing Countries Clinical Trials Partnership Background Cryptococcus is the most common cause of adult meningitis in Africa . We evaluated the activity of adjunctive sertraline , previously demonstrated to have in vitro and in vivo activity against Cryptococcus . Methods We enrolled 172 HIV-infected Ug and ans with cryptococcal meningitis from August 2013 through August 2014 into an open-label dose-finding study to assess safety and microbiologic efficacy . Sertraline 100–400mg/day was added to st and ard therapy of amphotericin + fluconazole 800mg/day . We evaluated early fungicidal activity via Cryptococcus cerebrospinal fluid ( CSF ) clearance rate , sertraline pharmacokinetics , and in vitro susceptibility . Findings Participants receiving any sertraline dose averaged a CSF clearance rate of −0·37 ( 95%CI : −0·41 , −0·33 ) colony forming units (CFU)/mL/day . Incidence of paradoxical immune reconstitution inflammatory syndrome ( IRIS ) was 5 % ( 2/43 ) and relapse was 0 % through 12-weeks . Sertraline reached steady state concentrations in plasma by day 7 , with median steady-state concentrations of 201 ng/mL ( IQR , 90–300 ; n=49 ) with 200mg/day and 399 ng/mL ( IQR , 279–560 ; n=30 ) with 400mg/day . Plasma concentrations reached 83 % of steady state levels by day 3 . The median projected steady state brain tissue concentration at 200mg/day was 3·7 ( IQR , 2·0–5·7 ) mcg/mL and 6·8 ( IQR , 4·6–9·7 ) mcg/mL at 400mg/day . Minimum inhibitory concentrations were ≤2 mcg/mL for 27 % ( 35/128 ) , ≤4 mcg/mL for 84 % ( 108/128 ) , ≤6 mcg/mL for 91 % ( 117/128 ) , and ≤8 mcg/mL for 100 % of 128 Cryptococcus isolates . Interpretation Sertraline had faster cryptococcal CSF clearance , decreased IRIS , and decreased relapse compared with historical experiences . Sertraline reaches therapeutic levels in a clinical setting . This inexpensive and off-patent oral medication is a promising adjunctive antifungal therapy . Funding National Institutes of Health , Gr and Challenges Canada BACKGROUND Cryptococcal disease remains an important cause of morbidity and mortality in HIV-infected individuals in sub-Saharan Africa , despite the introduction of antiretroviral therapy . We studied fluconazole as primary prophylaxis against cryptococcal disease in patients awaiting or starting antiretroviral therapy in Ug and a. METHODS In this prospect i ve , double-blind r and omised controlled trial , we enrolled HIV-positive adults with CD4 counts less than 200 cells per μL , cryptococcal antigen (CrAg)-negative , naive for antiretroviral therapy , and coming from five local AIDS organisations in Masaka district , Ug and a. Enrolment took place between Sept 14 , 2004 , and Feb 1 , 2008 . Participants were r and omly allocated to placebo or 200 mg fluconazole three times per week ( 1:1 ) in blocks of 40 . R and omisation was done with ralloc procedure in Stata . Participants were review ed after 4 weeks and referred for antiretroviral therapy , then seen every 8 weeks . Participants discontinued trial treatment when CD4 counts reached 200 cells per μL ( median 197 days ) . Primary endpoints were invasive cryptococcal disease and all-cause mortality . Secondary endpoints were time to first episode and incidence of oesophageal c and idosis , time to first episode and incidence of oropharyngeal or vaginal c and idosis , and time to first hospital admission or death . The primary safety endpoint was cessation of trial drug because of transaminase concentrations higher than five times the upper limit of normal ( ULN ) , or other major adverse events . Analyses were done by intention to treat and included all participants enrolled in the trial . Participants and research ers were masked to group assignment . This trial is registered with controlled-trials.com , number IS RCT N 76481529 . RESULTS Of 1519 individuals enrolled , 760 participants received fluconazole and 759 received placebo . 19 developed cryptococcal disease , one in the fluconazole group and 18 in the placebo group ( p=0·0001 ) ; adjusted HR ( aHR ) 18·7 ( 95 % CI 2·5 - 140·7 ) . One case of cryptococcal disease could be prevented by treating 44·6 patients with baseline CD4 counts lower than 200 cells per μL. Fluconazole was effective against cryptococcal disease both before ( aHR=11·0 [ 1·4 - 85·3 ] ) and after start of antiretroviral therapy ( no cases in fluconazole vs seven cases on placebo ) . Seven participants died from cryptococcal disease , none in the fluconazole group . All-cause mortality ( n=189 ) did not differ between the two groups ( p=0·46 ) . Fluconazole reduced the time to first episode of oesophageal , and oropharyngeal and vaginal c and idosis , as well as the incidence of all c and idosis ( p<0·0001 ) , but had no effect on hospital admission or death . The frequency of elevated transaminases ( > 5 × ULN ) was similar between groups ( aHR=0·94 [ 0·65 - 1·35 ] ) . CONCLUSIONS Fluconazole was safe and effective as primary prophylaxis against cryptococcal disease , both before and during early antiretroviral treatment . Cryptococcal infection was less common than anticipated because of the rapid commencement of antiretroviral therapy and exclusion of those with positive CrAg . In patients with negative CrAg on screening , fluconazole prophylaxis can prevent cryptococcal disease while waiting for and in the early weeks of antiretroviral therapy , particularly in those with CD4 counts of less than 100 cells per μL. FUNDING Medical Research Council , UK , and Rockefeller Foundation The effect of fluconazole prophylaxis on the vaginal flora of 323 human immunodeficiency virus-infected women was evaluated in a multicenter , r and omized , double-blind , placebo-controlled trial . Women with CD4 cell counts of < or = 300/mm3 received either 200 mg of fluconazole per week or placebo . Vaginal surveillance cultures were performed every 3 months . After a follow-up of 29 months , C and ida albicans was recovered from 53 % of patients receiving fluconazole and 68 % of patients assigned placebo . Fluconazole was associated with a 50 % reduction in the odds of being colonized with C. albicans but with higher rates for non-albicans C and ida species . C and ida glabrata was recovered from 40 women assigned fluconazole and 29 assigned placebo ( relative odds , 1.96 ; 95 % confidence interval , 0.98 - 3.94 ) . Fluconazole had an early and persistent effect on the vaginal mycoflora , with the emergence of C. glabrata vaginal colonization within the first 6 months . The effect of fluconazole prophylaxis can be attributed to the reduction in vaginal C. albicans colonization ; however , C. glabrata colonization rapidly supervened PURPOSE The effects of continuous or intermittent therapy with fluconazole on the recurrence of and the development of fluconazole resistance are not known . PATIENTS AND METHODS We studied human immunodeficiency virus (HIV)-positive patients with CD4 cell count < 350 x 10(6)/L and oropharyngeal c and idiasis in a prospect i ve , r and omized study . After initial treatment , 20 patients ( 16 of whom completed 3 months of follow-up ) received continuous fluconazole at 200 mg/day , and 48 patients ( 28 of whom completed follow-up ) received intermittent therapy at the time of symptomatic relapses . Oral sample s were obtained weekly during episodes of infection and quarterly as surveillance cultures . Development of resistance was defined as a fourfold rise in minimum inhibitory concentration ( MIC ) to at least 16 microg/mL from the initial culture in the same species , the emergence of new , resistant ( MIC > or = 16 microg/mL ) species , or a significant increase in the proportion of resistant isolates . RESULTS During a mean follow-up of 11 months , median annual relapse rates were lower in patients on continuous therapy ( 0 episodes/year ) than in patients on intermittent therapy ( 4.1 episodes/year ; P < 0.001 ) . Sterile cultures were seen in 6 of 16 ( 38 % ) patients on continuous therapy compared with 3 of 28 ( 11 % ) on intermittent therapy ( P = 0.04 ) . Microbiological resistance developed in 9 of 16 ( 56 % ) patients on continuous treatment , compared with 13 of 28 ( 46 % ) on intermittent treatment ( P = 0.75 ) . However , despite isolates with increased MICs , 42 of 44 patients responded to fluconazole in doses up to 800 mg/day . CONCLUSIONS In patients with frequent recurrences , continuous suppressive therapy significantly reduced relapses and colonization . Resistance occurred with both continuous and intermittent therapy ; however , therapeutic responses were excellent BACKGROUND In human immunodeficiency virus (HIV)-infected patients , fluconazole prophylaxis is associated with reductions in the rate of fungal infection . However , concerns exist with regard to the use of fluconazole prophylaxis and the risk of development of fluconazole treatment-refractory infections . METHODS We performed a r and omized , open-label trial that compared oral fluconazole given continuously ( 200 mg 3 times weekly ; the \" continuous fluconazole arm \" ) with fluconazole that was provided only for episodes of orophaynge \n Output:\n " }, { "from": "agent", "value": "Authors ' conclusions Antifungal prophylaxis reduced the risk of developing and dying from cryptococcal disease .\nTherefore , where CrAG screening is not available , antifungal prophylaxis may be used in patients with low CD4 counts at diagnosis and who are at risk of developing cryptococcal disease" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Considering formocresol 's toxicity , Ca(OH)(2 ) partial pulpotomy ( PP ) was studied as a treatment alternative . AIM To compare success rates of Ca(OH)(2 ) PP versus formocresol pulpotomy ( FP ) treatment of pulpally exposed lower primary molars . DESIGN A total of 84 lower primary molars , which met study criteria , from 56 child patients were r and omly assigned for each treatment . After treatment , blinded clinical and radiographic evaluation with 96.9 % and 90 % reliability was performed at 6-month intervals to determine treatment success/failure . Chi-squared test was used to compare success rates between the two treatments . RESULTS The success rates from 6 to 36 months for PP ranged from 95.03 % to 75 % , whereas for FP , it was 92.7 - 74.2 % . The success rates for the two treatments at each 6-month interval were not different ( P ≥ 0.05 ) . The most frequent failure was internal resorption , affecting five FP teeth and three PP teeth . The resorption was arrested in five of the teeth and was replaced by a radiopaque calcified tissue in one case . CONCLUSION Considering the favourable clinical and radiographic success rate of PP and the potentially toxic effects of formocresol leads us to recommend the use of PP instead of FP in primary teeth with deep carious lesions Aim To compare the clinical and radiographic success rates of three different pulpotomy agents in primary molars after 18 months . Methods The study was carried out with 51 primary molars of children aged 5–9 years old . The teeth were r and omly assigned to the experimental or control groups . After coronal pulp removal and haemostasis , the remaining pulp tissue was covered with Biodentine ® or mineral trioxide aggregate in the experimental groups . In the control group , formocresol was placed with a cotton pellet over the pulp tissue for 5 min and after removal the pulp tissue was covered with zinc oxide – eugenol ( ZOE ) paste . All teeth were immediately restored with reinforced ZOE base and resin modified glass-ionomer cement , and later with pre-formed metal crowns . Follow-up assessment s were carried out after 3 , 6 , 12 and 18 months . Results Forty-five teeth were available for follow up at the end of 18 months . All of the available teeth for mineral trioxide aggregate and Biodentine ® were clinical ly successful , as were 73.3 % of the FC group . Radiographic success rate for the formocresol group at 18 months follow up was 73.3 , 100 % for mineral trioxide aggregate and 86.6 % for Biodentine ® group . Conclusion Mineral Trioxide aggregate and Biodentine ® showed more favourable results than formocresol PURPOSE The purpose of this study was to investigate the outcomes of vital primary molar pulpotomy when there is no direct contact between eugenol and the vital pulp . Four pulpotomy techniques were compared : ( 1 ) ferric sulfate ( FS ) pulpotomy ; ( 2 ) eugenol-free FS pulpotomy ; ( 3 ) mineral trioxide aggregate ( MTA ) pulpotomy ; and ( 4 ) FS/MTA pulpotomy . METHODS The pulpotomy technique assigned to each molar was determined by r and om selection . Two blinded , disinterested raters classified each molar into 1 of 3 radiographic outcomes : ( 1 ) N = normal molar without pathologic change ; ( 2 ) Po = pathologic change present , follow-up recommended ; ( 3 ) Px = pathologic change present , extract . RESULTS A total of 92 patients with 227 pulpotomy-treated molars returned for at least 1 recall examination . Median follow-up for molars was 24 months ( range=12 - 38 months ) . MTA molars demonstrated significantly fewer Px radiographic outcomes than FS molars ( P=.002 , chi-square test ) . Eugenol-free FS molars demonstrated significantly more Px radiographic outcomes than MTA ( P<.001 , chi-square test ) or FS/MTA ( P=.002 , chi-square test ) molars . Significantly lower survival was demonstrated for eugenol-free FS molars compared to MTA molars ( P=.02 , log-rank test ) over 6 to 38 months . CONCLUSIONS Outcomes for mineral trioxide aggregate pulpotomy were superior to ferric sulfate and eugenol-free ferric sulfate pulpotomy after a median follow-up of 2 years Introduction : This trial was design ed to evaluate the clinical and radiographic success rates of calcium-enriched mixture ( CEM ) cement with and without low level laser therapy ( LLLT ) and compare them to that of formocresol ( FC ) and ferric sulfate ( FS ) in primary molar pulpotomies . Methods and Material s : This r and omized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3 - 9 years . Patients with at least four primary molars needing pulpotomy , were included in order to have each tooth assigned r and omly in one of the four following groups ; FC , FS , CEM , and LLLT/CEM . Six- and twelve-month follow-up periods were conducted in order to enable a clinical and radiographic evaluation of the treated teeth . Collected data were analyzed using Cochran Q Tests . Results : The 12-month clinical success rate for each technique was : FC=100 % , FS=95 % , CEM=97.5 % and LLLT/CEM=100 % with no significant differences ( P>0.05 ) . Furthermore , 12-month radiographic success rate for each technique was : FC=100 % , FS=92.5 % , CEM=95 % and LLLT/CEM=100 % with no significant differences ( P>0.05 ) . Conclusion : Favorable outcomes of four treatment techniques in pulpotomy of primary molar teeth were comparable . CEM with/without LLLT may be considered as a safe and successful pulpotomy treatment modality compared to current conventional methods Introduction : Pulpotomy technique is most widely accepted clinical procedure for treating primary teeth with coronal pulp inflammation caused by caries with no involvement of the radicular pulp . Aim and Objective : The aim of the study was to evaluate the success and efficacy of mineral trioxide aggregate ( MTA ) and antioxidant mix as pulpotomy agents both clinical ly and radiographically . Material s and Methods : A total of forty primary molars in children aged between 6 and 9 years , requiring for pulpotomy procedures , were selected . R and om sample s distribution was done , antioxidant mix ( n = 20 ) and MTA ( n = 20 ) both were used as pulpotomy agent . Under rubber dam isolation , pulpotomy procedure was performed in all sample s followed by restoration with stainless steel crowns . Later , the patients were recalled after 6 and 12 months for clinical and radiographic evaluation . The data were evaluated using Fisher 's exact test . Results : Statistically analysis shows no significant difference between the two groups ( P > 0.05 ) with respect to clinical and radiographic success rate , but antioxidant mix showed more efficient result than MTA . Conclusion : Antioxidant mix pulpotomy is more biocompatible and cost effective than any other commercially available medicament Purpose The aim of this study was to compare the effect of white mineral trioxide aggregate ( MTA ) to that of formocresol ( FC ) as pulp dressing agents in pulpotomised primary molars . Methods In this clinical trial study , 60 lower second primary molars of 46 children were treated by a conventional pulpotomy technique . The teeth were r and omly assigned to the MTA ( experimental ) and FC ( control ) groups by r and om numbered table . Following removal of the coronal pulp and haemostasis , the pulp stumps were covered with an MTA paste in the experimental group . In the control group , FC was placed with a cotton pellet over the pulp stumps . The teeth of both groups were restored with stainless steel crowns . Children arrived for clinical and radiographic follow-up evaluation after 6 , 12 and 24 months . Results The treated teeth in FC group ( n = 18 ) were clinical ly and radiographically successful after 24 months . The radiographic follow-up evaluation revealed one failure ( furcation involvement ) in 18 molars treated with MTA after 24 months . The treated teeth in MTA group were clinical ly successful 24 months postoperatively . Pulp canal obliteration was observed in one of the teeth treated with MTA and four of the teeth treated with FC . Conclusion MTA could be used as a safe medicament for pulpotomy in cariously exposed primary molars and could be a substitute for FC The aim of this study was to compare the effect of ferric sulfate ( FS ) to that of dilute formocresol ( DFC ) as pulp dressing agents in pulpotomized primary molars . Ninety-six primary molars in 72 children were treated by a conventional pulpotomy technique . Fifty-eight teeth were treated by a FS solution for 15 sec , rinsed , and covered by zinc oxide-eugenol paste ( ZOE ) . In another 38 teeth , a cotton pellet moistened with 20 % DFC was placed for 5 min , removed , and the pulp stumps were covered by ZOE paste . The teeth of both groups were sealed by a second layer of intermediate restorative material ( IRM ) and restored with a stainless steel crown . This is a report of the clinical and radiographic examination of 55 teeth dressed with FS and 37 teeth fixed with DFC , that have been treated 6 to 34 months previously ( mean 20.5 months ) . Four teeth were excluded from the study due to failure of the patient to present for recall . Success rates of 92.7 % for the FS , and of 83.8 % for the DFC were not significantly different . Four teeth ( 7.2 % ) of the FS group and two ( 5.4 % ) of the DFC group presented internal resorption . Inter-radicular radiolucencies were observed in two teeth of the FS group and three teeth of the DFC group . The latter also presented periapical lesions . Success rates of both groups were similar to those of previous studies utilizing the traditional Buckley 's formocresol OBJECTIVES The aim of the present study was to conduct a clinical and radiographic long-term evaluation of pulpotomy in temporary molars performed with Grey and White Mineral Trioxide Aggregate ( MTA ) and compare the results of Grey and White MTA pulpotomies in a sample of 233 primary molars with a maximum follow-up period of 84 months . METHODS The sample was selected from patients treated at the Department of Pediatric Dentistry , Faculty of Dentistry , Complutense University of Madrid , Spain . This prospect i ve study included first and second primary molars treated with pulpotomy with Grey or White MTA , controlled for a maximum follow-up period of 84 months . Statistical analysis of clinical and radiographic findings was completed using ANOVA ( P<0.05 ) . RESULTS Follow-up evaluations , performed every 6 months , revealed that only 2 molars treated with White MTA presented abscess and pathological mobility . Radiographic examination of the 210 molars revealed unfavourable pulp response in only 6 molars ( internal or furcation root resorption ) , without statistically significant differences between Grey and White MTA . Two radiological findings were noticed : dentine bridge formation and partial or total root canal stenosis . Grey MTA induced a higher percentage of dentine bridges with statistically significant differences ( P<0.05 ) , and a higher percentage of pulp canal stenosis , without a statistically significant difference . CONCLUSIONS Grey and White MTA presented high levels of clinical and radiographic success . Although the present study showed evidence of a very good biologic response with both types of MTA , Grey MTA showed significantly higher number of dentine bridge formation than White MTA AIM To compare the treatment outcomes of calcium-enriched mixture ( CEM ) cement and mineral trioxide aggregate ( MTA ) as pulp dressing bio material s in vital pulpotomy of carious primary molars . STUDY DESIGN split-mouth r and omised clinical trial . MATERIAL S AND METHODS Forty children aged 4 - 8 years with 2 carious teeth requiring pulpotomy were selected and r and omly assigned to MTA ( n = 40 ) or CEM ( n = 40 ) groups . After coronal pulp removal , the remaining radicular pulp was covered with an appropriate bio material ; the teeth were then permanently restored . Clinical /radiographic success/failures were blindly evaluated at 6- , 12- and 24-month follow-ups . STATISTICS the recorded data were analyzed with McNemar test and GEE . RESULTS A total of 36 , 33 and 35 patients were available for 6- , 12- and 24-month follow-ups , respectively . At the 12-month follow-up only one and three teeth in the CEM and MTA groups had pathologic external root resorption , respectively . The resorbed teeth were then missed due to extraction /exfoliation at the 24-month follow-up ; all other treated teeth were sign/symptom-free . Overall , clinical and radiographic outcomes in both MTA/CEM groups were comparable at the three follow-ups without significant differences . Time had no significant effect on the success . CONCLUSION MTA and CEM demonstrated favourable treatment outcomes for pulpotomy of carious primary molars ; CEM may be an effective pulp dressing bio material PURPOSE The objective of this study was to assess the effect of mineral trioxide aggregate ( MTA ) as pulp dressing material following pulpotomy in primary molars with carious pulp exposure and compare them to those of formocresol ( FC ) . METHODS Of 33 children , primary molars treated via a conventional pulpotomy technique were r and omly assigned to the MTA group ( 33 teeth ) or FC group ( 29 teeth ) . Clinical and radiographic \n Output:\n " }, { "from": "agent", "value": "Mineral trioxide aggregate ( MTA ) , Biodentine and ferric sulphate yielded good clinical results over time and might be safely used in the pulpotomies of primary molars .\nAmong agents , MTA seemed to be the material of choice .\nOn the contrary , calcium hydroxide showed the worst clinical performance .\nAlthough clinical ly successful , formocreosol should be replaced by other material s , due to its potential cytotoxicity and carcinogenicity .\nConclusion : MTA seemed to be the gold st and ard material in the pulpotomy of primary teeth .\nPromising results were also provided by calcium silicate-based cements ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Of 22 r and omized trials of rehabilitation with exercise after myocardial infa rct ion ( MI ) , one trial had results that achieved conventional statistical significance . To determine whether or not these studies , in the aggregate , show a significant benefit of rehabilitation after myocardial infa rct ion , we performed an overview of all r and omized trials , involving 4,554 patients ; we evaluated total and cardiovascular mortality , sudden death , and fatal and nonfatal reinfa rct ion . For each endpoint , we calculated an odds ratio ( OR ) and 95 % confidence interval ( 95 % CI ) for the trials combined . After an average of 3 years of follow-up , the ORs were significantly lower in the rehabilitation than in the comparison group : specifically , total mortality ( OR = 0.80 [ 0.66 , 0.96 ] ) , cardiovascular mortality ( OR = 0.78 [ 0.63 , 0.96 ] ) , and fatal reinfa rct ion ( OR = 0.75 [ 0.59 , 0.95 ] ) . The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year ( OR = 0.63 [ 0.41 , 0.97 ] ) . The data were compatible with a benefit at 2 ( OR = 0.76 [ 0.54 , 1.06 ] ) and 3 years ( OR = 0.92 [ 0.69 , 1.23 ] ) , but these findings were not statistically significant . For nonfatal reinfa rct ion , there were no significant differences between the two groups after 1 ( OR = 1.09 [ 0.76 , 1.57 ] ) , 2 ( OR = 1.10 [ 0.82 , 1.47 ] ) , or 3 years ( OR = 1.09 [ 0.88 , 1.34 ] ) of follow-up . The observed 20 % reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfa rct ion throughout at least 3 years and a reduction in sudden death during the 1st year after infa rct ion and possibly for 2 - 3 years . With respect to the independent effects of the physical exercise component of cardiac rehabilitation , the relatively small number of \" exercise only \" trials , combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion . To do so would require a r and omized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview BACKGROUND Recent clinical trials have shown that modification of plasma lipoprotein concentrations can favorably alter progression of coronary atherosclerosis , but no data exist on the effects of a comprehensive program of risk reduction involving both changes in lifestyle and medications . This study tested the hypothesis that intensive multiple risk factor reduction over 4 years would significantly reduce the rate of progression of atherosclerosis in the coronary arteries of men and women compared with subjects r and omly assigned to the usual care of their physician . METHODS AND RESULTS Three hundred men ( n = 259 ) and women ( n = 41 ) ( mean age , 56 + /- 7.4 years ) with angiographically defined coronary atherosclerosis were r and omly assigned to usual care ( n = 155 ) or multifactor risk reduction ( n = 145 ) . Patients assigned to risk reduction were provided individualized programs involving a low-fat and -cholesterol diet , exercise , weight loss , smoking cessation , and medications to favorably alter lipoprotein profiles . Computer-assisted quantitative coronary arteriography was performed at baseline and after 4 years . The main angiographic outcome was the rate of change in the minimal diameter of diseased segments . All subjects underwent medical and risk factor evaluations at baseline and yearly for 4 years , and reasons for all hospitalizations and deaths were documented . Of the 300 subjects r and omized , 274 ( 91.3 % ) completed a follow-up arteriogram , and 246 ( 82 % ) had comparative measurements of segments with visible disease at baseline and follow-up . Intensive risk reduction result ed in highly significant improvements in various risk factors , including low-density lipoprotein cholesterol and apolipoprotein B ( both , 22 % ) , high-density lipoprotein cholesterol ( + 12 % ) , plasma triglycerides ( -20 % ) , body weight ( -4 % ) , exercise capacity ( + 20 % ) , and intake of dietary fat ( -24 % ) and cholesterol ( -40 % ) compared with relatively small changes in the usual-care group . No change was observed in lipoprotein(a ) in either group . The risk-reduction group showed a rate of narrowing of diseased coronary artery segments that was 47 % less than that for subjects in the usual-care group ( change in minimal diameter , -0.024 + /- 0.066 mm/y versus -0.045 + /- 0.073 mm/y ; P < .02 , two-tailed ) . Three deaths occurred in each group . There were 25 hospitalizations in the risk-reduction group initiated by clinical cardiac events compared with 44 in the usual-care group ( rate ratio , 0.61 ; P = .05 ; 95 % confidence interval , 0.4 to 0.9 ) . CONCLUSIONS Intensive multifactor risk reduction conducted over 4 years favorably altered the rate of luminal narrowing in coronary arteries of men and women with coronary artery disease and decreased hospitalizations for clinical cardiac events Background Significant regression of coronary and femoral atherosclerotic lesions has been documented by angiographic studies using aggressive lipid-lowering treatment . This study tested the applicability and effects of intensive physical exercise and low-fat diet on coronary morphology and myocardial perfusion in nonselected patients with stable angina pectoris . Methods and Results Patients were recruited after routine coronary angiography for stable angina pectoris ; they were r and omized to an intervention group ( n = 56 ) and a control group on “ usual care ” ( n = 57 ) . Treatment comprised intensive physical exercise in group training sessions ( minimum , 2 hr/wk ) , daily home exercise periods ( 20 min/d ) , and low-fat , low-cholesterol diet ( American Heart Association recommendation , phase 3 ) . No lipid-lowering agents were prescribed . After 12 months of participation , repeat coronary angiography was performed ; relative and minimal diameter reductions of coronary lesions were measured by digital image processing . Change in myocardial perfusion was assessed by 201TI scintigraphy . In patients participating in the intervention group , body weight decreased by 5 % ( p<0.001 ) , total cholesterol by 10 % ( p<0.001 ) , and triglycerides by 24 % ( p<0.001 ) ; high density lipoproteins increased by 3 % ( p = NS ) . Physical work capacity improved by 23 % ( p<0.0001 ) , and myocardial oxygen consumption , as estimated from maximal rate-pressure product , by 10 % , ( p<0.05 ) . Stress-induced myocardial ischemia decreased concurrently , indicating improvement of myocardial perfusion . Based on minimal lesion diameter , progression of coronary lesions was noted in nine patients ( 23 % ) , no change in 18 patients ( 45 % ) , and regression in 13 patients ( 32 % ) . In the control group , metabolic and hemodynamic variables remained essentially unchanged , whereas progression of coronary lesions was noted in 25 patients ( 48 % ) , no change in 18 patients ( 35 % ) , and regression in nine patients ( 17 % ) . These changes were significantly different from the intervention group ( p<0.05 ) . Conclusions In patients participating in regular physical exercise and low-fat diet , coronary artery disease progresses at a slower pace compared with a control group on usual care Background —Whether cardiac rehabilitation ( CR ) is effective in patients older than 75 years , who have been excluded from most trials , remains unclear . We enrolled patients 46 to 86 years old in a r and omized trial and assessed the effects of 2 months of post-myocardial infa rct ion ( MI ) CR on total work capacity ( TWC , in kilograms per meter ) and health-related quality of life ( HRQL ) . Methods and Results —Of 773 screened patients , 270 without cardiac failure , dementia , disability , or contraindications to exercise were r and omized to outpatient , hospital-based CR ( Hosp-CR ) , home-based CR ( Home-CR ) , or no CR within 3 predefined age groups ( middle-aged , 45 to 65 years ; old , 66 to 75 years ; and very old , > 75 years ) of 90 patients each . TWC and HRQL were determined with cycle ergometry and Sickness Impact Profile at baseline , after CR , and 6 and 12 months later . Within each age group , TWC improved with Hosp-CR and Home-CR and was unchanged with no CR . The improvement was similar in middle-aged and old persons but smaller , although still significant , in very old patients . TWC reverted toward baseline by 12 months with Hosp-CR but not with Home-CR . HRQL improved in middle-aged and old CR and control patients but only with CR in very old patients . Complications were similar across treatment and age groups . Costs were lower for Home-CR than for Hosp-CR . Conclusions —Post-MI Hosp-CR and Home-CR are similarly effective in the short term and improve TWC and HRQL in each age group . However , with lower costs and more prolonged positive effects , Home-CR may be the treatment of choice in low-risk older patients BACKGROUND Increases in life stress have been linked to poor prognosis , after myocardial infa rct ion ( MI ) . Previous research suggested that a programme of monthly screening for psychological distress , combined with supportive and educational home nursing interventions for distressed patients , may improve post-MI survival among men . Our study assessed this approach for both men and women . We aim ed to find out whether the programme would reduce 1-year cardiac mortality for women and men . METHODS We carried out a r and omised , controlled trial of 1376 post-MI patients ( 903 men , 473 women ) assigned to the intervention programme ( n = 692 ) or usual care ( n = 684 ) for 1 year . All patients completed a baseline interview that included assessment of depression and anxiety . Survivors were also interviewed at 1 year . FINDINGS The programme had no overall survival impact . Preplanned analyses showed higher cardiac ( 9.4 vs 5.0 % , p = 0.064 ) and all-cause mortality ( 10.3 vs 5.4 % , p = 0.051 ) among women in the intervention group . There was no evidence of either benefit or harm among men ( cardiac mortality 2.4 vs 2.5 % , p = 0.94 ; all-cause mortality 3.1 vs 3.1 % , p = 0.93 ) . The programme 's impact on depression and anxiety among survivors was small . INTERPRETATION Our results do not warrant the routine implementation of programmes that involve psychological-distress screening and home nursing intervention for patients recovering from MI . The poorer overall outcome for women , and the possible harmful impact of the intervention on women , underline the need for further research and the inclusion of adequate numbers of women in future post-MI trials Abstract Objective : To evaluate the effects of secondary prevention clinics run by nurses in general practice on the health of patients with coronary heart disease . Design : R and omised controlled trial of clinics over one year with assessment by self completed postal question naires and audit of medical records at the start and end of the trial . Setting : R and om sample of 19 general practice s in northeast Scotl and . Subjects : 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease who did not have terminal illness or dementia and were not housebound . Intervention : Clinic staff promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures : Health status measured by the SF-36 question naire , chest pain by the angina type specification , and anxiety and depression by the hospital anxiety and depression scale . Use of health services before and during the study . Results : There were significant improvements in six of eight health status domains ( all functioning scales , pain , and general health ) among patients attending the clinic . Role limitations attributed to physical problems improved most ( adjusted difference 8.52 , 95 % confidence interval 4.16 to 12.9 ) . Fewer patients reported worsening chest pain ( odds ratio 0.59 , 95 % confidence interval 0.37 to 0.94 ) . There were no significant effects on anxiety or depression . Fewer intervention group patients required hospital admissions ( 0.64 , 0.48 to 0.86 ) , but general practitioner consultation rates did not alter . Conclusions : Within their first year secondary prevention clinics improved patients ' health and reduced hospital admissions . Key messages Nurse led clinics in general practice were used to promote secondary prevention to patients with coronary heart disease Within the first year the health of patients invited to the clinics improved Most benefit was in functional status , but chest pain improved too There was no effects on anxiety or depression There were significant reductions in hospital admissions in the first The Women ’s Lifestyle Heart Trial was a small ( N=28 ) r and omized controlled trial to evaluate the effects of a comprehensive lifestyle self-management program ( very low-fat vegetarian \n Output:\n " }, { "from": "agent", "value": "Since exercise training confers substantial physiologic and clinical benefits and activity levels are inversely proportional to cardiovascular mortality ( 9 ) , it is not surprising that trials of exercise programs found positive effects on survival ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Tobacco Dependence among smokers with psychiatric disorders has been under-addressed by the mental health , addictions , and tobacco control communities . This study examined depressed smokers ' readiness to quit and the applicability of the Stages of Change framework to a psychiatric sample . Currently depressed smokers ( N=322 ) were recruited from four outpatient psychiatric clinics . Participants averaged 16 cigarettes per day ( S.D.=10 ) and 24 years ( S.D.=13 ) of smoking . The majority ( 79 % ) reported intention to quit smoking with 24 % ready to take action in the next 30 days . Individuals in the preparation stage reported more prior quit attempts , a greater commitment to abstinence , increased recognition of the cons of smoking , and greater use of the processes of change . Precontemplators were least likely to identify a goal related to their smoking behavior . Depressive symptom severity and history of recurrent depressive episodes were unrelated to readiness to quit . This study is one of the first to examine the smoking behaviors of currently depressed psychiatric out patients . The level and longevity of their tobacco use underscore the need for cessation interventions . The consistency in hypothesized patterns among theoretical constructs of the Stages of Change model supports the transfer of stage-tailored interventions to this clinical population BACKGROUND R and omized efficacy clinical trials conducted in research setting s may not accurately reflect the benefits of tobacco dependence treatments when used in real-world clinical setting s. Effectiveness trials ( eg , in primary care setting s ) are needed to estimate the benefits of cessation treatments in real-world use . METHODS A total of 1346 primary care patients attending routine appointments were recruited by medical assistants in 12 primary care clinics . Patients were r and omly assigned to 5 active pharmacotherapies : 3 monotherapies ( nicotine patch , nicotine lozenge , and bupropion hydrochloride sustained release [ SR ] ) and 2 combination therapies ( patch + lozenge and bupropion SR + lozenge ) . Patients were referred to a telephone quit line for cessation counseling . Primary outcomes included 7-day point prevalence abstinence at 1 week , 8 weeks , and 6 months after quitting and number of days to relapse . RESULTS Among 7128 eligible smokers ( > or = 10 cigarettes per day ) attending routine primary care appointments , 1346 ( 18.9 % ) were enrolled in the study . Six-month abstinence rates for the 5 active pharmacotherapies were the following : bupropion SR , 16.8 % ; lozenge , 19.9 % ; patch , 17.7 % ; patch + lozenge , 26.9 % ; and bupropion SR + lozenge , 29.9 % . Bupropion SR + lozenge was superior to all of the monotherapies ( odds ratio , 0.46 - 0.56 ) ; patch + lozenge was superior to patch and bupropion monotherapies ( odds ratio , 0.56 and 0.54 , respectively ) . CONCLUSIONS One in 5 smokers attending a routine primary care appointment was willing to make a serious quit attempt that included evidence -based counseling and medication . In this comparative effectiveness study of 5 tobacco dependence treatments , combination pharmacotherapy significantly increased abstinence compared with monotherapies . Provision of free cessation medications plus quit line counseling arranged in the primary care setting holds promise for assisting large numbers of smokers to quit . Trial Registration clinical trials.gov Identifier : NCT00296647 BACKGROUND People with psychiatric disorders are more likely to smoke and smoke more heavily than the general population , and they suffer disproportionally from smoking-related illnesses . However , little is known about how quitting versus continuing to smoke affects mental health and the likelihood of developing a psychiatric diagnosis . This study used data from a large prospect i ve clinical trial to examine the relations of smoking cessation success with psychiatric diagnoses 1 and 3 years after the target quit day . METHODS This study enrolled 1504 smokers ( 83.9 % white ; 58.2 % female ) in a cessation trial that involved the completion of the Composite International Diagnostic Interview to assess psychiatric diagnoses and biochemical confirmation of point-prevalence abstinence at Baseline and Years 1 and 3 . RESULTS Regression analyses showed that , after controlling for pre-quit ( past-year ) diagnoses , participants who were smoking at the Year 3 follow-up were more likely to have developed and maintained a substance use or major depressive disorder by that time than were individuals who were abstinent at Year 3 . CONCLUSIONS Quitting smoking does not appear to negatively influence mental health in the long-term and may be protective with respect to depression and substance use diagnoses ; this should encourage smokers to make quit attempts and encourage clinicians to provide cessation treatment It was hypothesized that smoking 's calming effects are cognitively mediated and depend on the presence of a benign distractor , smoking narrows the focus of attention , thereby reducing anxiety by facilitating distraction from stressful cognitions ( cf . C. M. Steele & R. A. Josephs 's [ 1988 ] attention-allocation model of alcohol reinforcement ) . This notion was tested by examining the effect of smoking ( vs. not smoking ) on anxiety with and without a concurrent distraction in 82 smokers ; distraction effects were also assessed in 42 nonsmokers . As predicted , smoking reduced anxiety only when paired with a distractor . Further , these findings could not be explained by direct nicotine effects or nicotine withdrawal . Several measures of attention allocation failed to confirm the hypothesized cognitive mechanisms , however . Implication s of the findings are discussed The effects of exposure to two classes of smoking-relevant cues ( environmental ; negative affect ) on desire to smoke and smoking topography were evaluated . Sixty chronic smokers were r and omly assigned to one of six groups in a two-way ANOVA design in which the salience of environmental cues and presence of negative affective cues were manipulated . This was followed by a 20-minute interval during which ad libitum smoking was videotaped in an unobtrusive manner . Results indicated that the experimental manipulations differentially influenced ratings of desire and topographical components of smoking behavior . Implication s are raised regarding the role of cue reactivity in the maintenance of smoking behavior This study is a r and omized , double-blind , placebo-controlled clinical trial examining the effects of an intensive cognitive-behavioral mood management treatment ( CBTD ) and of bupropion , both singularly and in combination , on smoking cessation in adult smokers . As an extension of our previous work , we planned to examine the synergistic effects of CBTD and bupropion on smoking cessation outcomes in general and among smokers with depression vulnerability factors . Participants were 524 smokers ( 47.5 % female , M ( age ) = 44.27 years ) who were r and omized to one of four 12-week treatments : ( a ) st and ard , cognitive-behavioral smoking cessation treatment ( ST ) plus bupropion ( BUP ) , ( b ) ST plus placebo ( PLAC ) , ( c ) st and ard cessation treatment combined with cognitive-behavioral treatment for depression ( CBTD ) plus BUP , and ( d ) CBTD plus PLAC . Follow-up assessment s were conducted 2 , 6 , and 12 months after treatment , and self-reported abstinence was verified biochemically . Consistent with previous studies , bupropion , in comparison with placebo , result ed in better smoking outcomes in both intensive group treatments . Adding CBTD to st and ard intensive group treatment did not result in improved smoking cessation outcomes . In addition , neither CBTD nor bupropion , either alone or in combination , was differentially effective for smokers with single-past-episode major depressive disorder ( MDD ) , recurrent MDD , or elevated depressive symptoms . However , findings with regard to recurrent MDD and elevated depressive symptoms should be interpreted with caution given the low rate of recurrent MDD and the low level of depressive symptoms in our sample . An a priori test of treatment effects in smokers with these depression vulnerability factors is warranted in future clinical trials BACKGROUND Nosological boundaries for depressive disorders as well as the prevalence and impact of ' subsyndromal ' depression remain unclear . AIMS To examine the impact of subsyndromal depressive disorders on health status and to assess if depressive disorders lie on a continuum of severity . METHOD The sample was composed of r and omly selected respondents from the general population in 68 countries from across the world participating in the World Health Organization 's World Health Survey . RESULTS The pattern of risk factors for depressive disorders was consistent across all types of depression ( subsyndromal , brief depressive episode and depressive episode ) : odds ratios for females ranged between 1.49 and 1.80 , and for the unemployed from 1.19 to 1.25 . All types of depression produced a significant decrement in health status compared with no depression after controlling for demographic variables , income and country . CONCLUSIONS Subthreshold depressive disorders occur commonly all across the world and are associated with the same risk factors everywhere . They produce significant decrements in health and do not qualitatively differ from full-blown episodes of depression as currently defined , and lie on a continuum with more severe forms of depressive episodes but are distinct from normal mood changes IMPORTANCE Reward-related disturbances after withdrawal from nicotine are hypothesized to contribute to relapse to tobacco smoking but mechanisms underlying and linking such processes remain largely unknown . OBJECTIVE To determine whether withdrawal from nicotine affects reward responsiveness ( ie , the propensity to modulate behavior as a function of prior reinforcement experience ) across species using translational behavioral assessment s in humans and rats . DESIGN , SETTING , PARTICIPANTS Experimental studies used analogous reward responsiveness tasks in both humans and rats to examine whether reward responsiveness varied in ( 1 ) an ad libitum smoking condition compared with a 24-hour acute nicotine abstinence condition in 31 human smokers with ( n = 17 ) or without ( n = 14 ) a history of depression ; ( 2 ) rats 24 hours after withdrawal from chronic nicotine ( n = 19 ) or saline ( n = 20 ) ; and ( 3 ) rats following acute nicotine exposure after withdrawal from either chronic nicotine or saline administration . MAIN OUTCOMES AND MEASURES Performance on a reward responsiveness task under nicotine and nonnicotine conditions . RESULTS In both human smokers and nicotine-treated rats , reward responsiveness was significantly reduced after 24-hour withdrawal from nicotine ( P < .05 ) . In humans , withdrawal-induced deficits in reward responsiveness were greater in those with a history of depression . In rats previously exposed to chronic nicotine , acute nicotine reexposure long after withdrawal potentiated reward responsiveness ( P < .05 ) . CONCLUSIONS AND RELEVANCE These findings across species converge in suggesting that organisms have diminished ability to modulate behavior as a function of reward during withdrawal of nicotine . This blunting may contribute to relapse to tobacco smoking , particularly in depression-vulnerable individuals , to reinstate responsiveness to natural rewards and to experience potentiated nicotine-induced reward responsiveness . Moreover , demonstration of behavioral homology across humans and rodents provides a strong translational framework for the investigation and development of clinical treatments targeting reward responsiveness deficits during early withdrawal of nicotine Two notions strongly held by many smokers are that negative mood increases smoking behavior and that this increase is due to the ability of smoking to alleviate negative affect . This study used a modified mood induction procedure to examine both the impact of smoking on induced mood , as well as the effect of induced mood on actual smoking behavior . Forty-eight smokers were r and omly assigned to a smoking or a water-drinking comparison group . Each participant attended 3 sessions during which 1 of 3 mood states ( positive , negative , or neutral ) was induced . Contrary to expectation , smoking did not attenuate negative affect . However , negative mood induction subsequently quickened latency to smoke and increased number of puffs consumed ad lib INTRODUCTION A growing literature suggests that anhedonia-an affective dimension related to the inability to experience pleasure-is associated with poor smoking cessation outcomes . Despite these findings , research of the motivational mechanisms linking anhedonia and smoking has been limited . Accordingly , the present study examined ( a ) relationships between anhedonia and motivationally relevant smoking characteristics and ( b ) whether anhedonia moderated the effects of tobacco deprivation on appetitive and aversive aspects of smoking urges . METHODS Smokers ( N = 212 ; > or=5 cigarettes/day ) first attended a baseline session during which measures of anhedonia and smoking characteristics were completed . Prior to a subsequent experimental session , a portion of participants were r and omized to one of two groups : ( a ) 12-hr tobacco deprivation before the session ( n = 51 ) and ( b ) ad libitum smoking ( n = 69 ) . RESULTS Smokers with higher levels of anhedonia reported a greater number of past failed quit attempts and a higher proportion of quit attempts that ended in rapid relapse within 24 hr , rs > .20 , ps < .05 . Anhedonia did not consistently correlate with smoking heaviness , chronicity , and dependence motives . Anhedonia significantly moderated the influence of tobacco deprivation on appetitive smoking urges , such that deprivation \n Output:\n " }, { "from": "agent", "value": "RESULTS Our review identified three primary mechanisms that underlie persistent smoking among depressed smokers : low positive affect , high negative affect and cognitive impairment .\nWe propose a novel application of incentive learning theory which posits that depressed smokers experience greater increases in the expected value of smoking in the face of these three motivational states , which promotes goal -directed choice of smoking behavior over alternative actions .\nThe incentive learning theory accounts for current evidence on how depression primes smoking behavior and provides a unique framework for conceptualizing psychological mechanisms of smoking maintenance among depressed smokers .\nTreatment should focus upon correcting adverse internal states and beliefs about the high value of smoking in those states to improve cessation outcomes for depressed smokers" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The objective of this study was to investigate the relation between the peripheral concentrations of the adrenal steroid hormones cortisol and dehydroepi and rosterone sulfate ( DHEAS ) and cognitive impairment and decline . A prospect i ve study design was used . The setting was a suburb of Rotterdam , The Netherl and s. The study population consisted of a sample of 189 healthy participants from the population -based Rotterdam Study , aged 55 - 80 yr , who were invited for an additional examination . Follow-up examinations took place 1.9 yr after baseline , on the average . We determined fasting blood levels of DHEAS before dexamethasone administration and of cortisol and corticosteroid-binding globulin before and after the administration of 1 mg dexamethasone overnight . The 30-point Mini-Mental State Examination ( MMSE ) was used to assess cognition . The associations with cognitive impairment ( MMSE score of < 26 ; 6 % of the sample ) and cognitive decline ( drop in MMSE score of > 1 point/yr ; 24 % ) were estimated using logistic regression , with adjustment for age , sex , education , and depressive symptoms . An increase of 1 SD in the estimate of free cortisol ( SD = 30.3 ) was associated with cognitive impairment , although not significantly [ odds ratio ( OR ) = 1.5 ; 95 % confidence interval ( CI ) , 0.9 - 2.4 ] . A 1 SD increase in the natural logarithm of cortisol after the administration of 1 mg dexamethasone ( SD = 0.68 ) was associated with an OR for cognitive decline of 1.5 ( 95 % CI , 1.0 - 2.3 ) . A 1 SD increase in DHEAS ( SD = 2.10 micromol/L ) was inversely , but nonsignificantly , related to cognitive impairment ( OR = 0.5 ; 95 % CI , 0.2 - 1.1 ) and cognitive decline ( OR = 0.6 ; 95 % CI , 0.4 - 1.1 ) . The ratio of free cortisol over DHEAS was significantly related to cognitive impairment ( OR = 1.8 ; 95 % CI , 1.0 - 3.2 ) . This prospect i ve study among healthy elderly subjects suggested that basal free cortisol levels were positively related to cognitive impairment , and cortisol levels after dexamethasone treatment were related to cognitive decline . There was an inverse , but nonsignificant , association between DHEAS and cognitive impairment and decline BACKGROUND In humans , concentrations of the adrenal steroid hormone dehydroepi and rosterone ( DHEA ) and its sulfate ester ( DHEAS ) decline with age . Results from studies in rodents have suggested that DHEA administration can improve memory performance as well as neuronal plasticity . However , a first study from our laboratory could not demonstrate beneficial effects of DHEA substitution on cognitive performance and well-being in elderly subjects . To further evaluate whether DHEA replacement has effects on the central nervous system , an experiment using event-related potentials ( ERPs ) was conducted . METHODS In this placebo-controlled crossover study , 17 elderly men ( mean age , 71.1 + /- 1.7 yr ; range 59 - 81 yr ) took placebo or DHEA ( 50 mg/day ) for 2 weeks ( double blind ) . After each treatment period subjects participated in an auditory oddball paradigm with three oddball blocks . In the first two blocks subjects had to count the rare tone silently , whereas , in the third block they had to press a button . In addition , memory tests assessing visual , spatial , and semantic memory as well as question naires on psychological and physical well-being were presented . RESULTS Baseline DHEAS levels were lower compared with young adults . After 2-week DHEA replacement , DHEAS levels rose 5-fold to levels observed in young men . DHEA substitution modulated the P3 component of the ERPs , which reflects information updating in short-term memory . P3 amplitude was increased after DHEA administration , and only selectively in the second oddball block . DHEA did not influence P3 latency . Moreover , DHEA did not enhance memory or mood . CONCLUSIONS A 2-week DHEA replacement in elderly men results in changes in electrophysiological indices of central nervous system stimulus processing if the task is performed repeatedly . However , these effects do not appear to be strong enough to improve memory or mood Dehydroepi and rosterone ( DHEA ) and its sulfate form ( DHEAS ) have been the focus of considerable publicity because of their demonstrated associations with a broad range of health outcomes . Yet , knowledge about the effects of endogenous DHEA(S ) on health in humans is limited and often inconclusive , largely because few of the studies have been based on prospect i ve surveys of population -representative sample s. This analysis uses a national longitudinal survey in Taiwan to investigate whether DHEAS is associated with subsequent changes ( 2000 - 2003 ) in functional limitations , cognitive impairment , depressive symptoms , and global self-rated health . Regression models based on this older Taiwanese sample show that among men , lower levels of DHEAS are related to declines in mobility and self-assessed health status and increases in depressive symptoms , while both low and very high levels of DHEAS are associated with poor cognitive function . There are no significant associations among women . These findings differ from those in a previous cross-sectional analysis based on the Taiwan study and underscore the importance of using prospect i ve data to examine the effects of DHEAS on health . The evidence based on this and other longitudinal studies suggests that endogenous DHEAS is related to health outcomes for men , but not women , in both Western and non-Western population This study explores the potential relationship between a series of cognitive abilities and testosterone , dehydroepi and rosterone ( DHEA ) , and rostenedione , and body mass index ( BMI ) measurements in 5-year-old children . 60 boys and 69 girls were administered a test ( K-BIT ) which provided measurements of fluid intelligence ( Matrices subtest ) , crystallized intelligence ( Vocabulary subtest ) , and IQ composite ( the combination of the two subtests ) ; a sub- sample of 48 boys and 61 girls was also subjected to diverse tests related to theory of mind ( affective labeling , appearance-reality distinction , display rules , and false belief ) . Testosterone , DHEA , and and rostenedione levels were measured using an enzyme immunoassay technique in saliva sample s. An analysis of variance failed to reveal any significant differences between boys and girls in any of the cognitive abilities assessed . The correlation analysis revealed a positive relationship between fluid intelligence and testosterone levels in boys , a negative relationship between crystallized intelligence and and rostenedione levels in girls , and between affective labeling and and rostenedione levels in boys . A multiple regression analysis indicated that and rostenedione and BMI were the best predictors for some of the cognitive abilities assessed The levels of dehydroepi and rosterone ( DHEA ) and its sulfate ester DHEAS decrease with age after a peak around 25 yr . Animal studies as well as the first studies in humans have generated the idea that DHEA replacement in elderly subjects may have beneficial effects on well-being and cognitive functions . In the present experiment 40 healthy elderly men and women ( mean age , 69 yr ) participated in a double blind , placebo-controlled DHEA substitution study . For 2 weeks subjects took 50 mg DHEA daily , followed by a 2-week wash-out period and a 2-week placebo period . The treatment sequence was r and omized in a cross-over design . After 2 weeks of DHEA or placebo , psychological and physical well-being as well as cognitive performance were assessed using several question naires and neuropsychological tests . All subjects had low DHEAS baseline levels . DHEA substitution lead to a 5-fold increase in DHEAS levels in women ( from 0.67 + /- 0.1 to 4.1 + /- 0.4 micrograms/mL ; P < 0.001 ) and men ( from 0.85 + /- 0.1 to 4.5 + /- 0.4 micrograms/mL ; P < 0.001 ) . DHEA , and rostenedione , and testosterone levels also increased significantly in both sexes ( all P < 0.001 ) . No significant changes were observed in insulin-like growth factor I or insulin-like growth factor-binding protein-3 levels . DHEA replacement had no strong beneficial effect on any of the measured psychological or cognitive parameters . Only women tended to report an increase in well-being ( P = 0.11 ) and mood ( P = 0.10 ) , as assessed with question naires . They also showed better performance in one of six cognitive tests ( picture memory ) after DHEA . However , after Bonferroni alpha adjustment , this difference was no longer significant . No such trend was observed in men ( P > 0.20 ) . Likewise , no beneficial effects of DHEA substitution could be observed in any of the other tests of the neuropsychological test battery in either sex ( all P > 0.20 ) . In conclusion , the present data do not support the idea of strong beneficial effects of a physiological DHEA substitution on well-being or cognitive performance in healthy elderly individuals BACKGROUND The observation that dehydroepi and rosterone ( DHEA ) concentrations decrease markedly with age has led to the hypothesis that declining DHEA concentrations may contribute to age-related changes in cognition . In the United States , DHEA is widely available as an over-the-counter supplement that individuals are using in an effort to ameliorate age-related cognitive and physical changes . OBJECTIVE To investigate the relationship between age-associated decreases in endogenous DHEA sulfate ( DHEA-S ) concentrations and declines in neuropsychological performance in a prospect i ve , longitudinal study . METHODS The subjects were 883 men from a community-dwelling volunteer sample in the Baltimore Longitudinal Study of Aging . The men were aged 22 to 91 years at the initial visit , and they were followed up for as long as 31 years ( mean , 11 . 55 years ) , with biennial re assessment s of multiple cognitive domains and contemporaneous measurement of serum DHEA-S concentrations . Outcome measures were the results of cognitive tests of verbal and visual memory , 2 tests of mental status , phonemic and semantic word fluency tests , and measures of visuomotor scanning and attention . Serum DHEA-S concentrations were determined by st and ard radioimmunoassay . RESULTS Neither the rates of decline in mean DHEA-S concentrations nor the mean DHEA-S concentrations within individuals were related to cognitive status or cognitive decline . A comparison between the highest and lowest DHEA-S quartiles revealed no cognitive differences , despite the fact that these groups differed in endogenous DHEA-S concentration by more than a factor of 4 for a mean duration of 12 years . CONCLUSION Our longitudinal results augment those of previous prospect i ve studies by suggesting that the decline in endogenous DHEA-S concentration is independent of cognitive status and cognitive decline in healthy aging men Dehydroepi and rosterone ( DHEA ) and its sulfate , DHEA-S , are plentiful adrenal steroid hormones that decrease with aging and may have significant neuropsychiatric effects . In this study , six middle-aged and elderly patients with major depression and low basal plasma DHEA f1p4or DHEA-S levels were openly administered DHEA ( 30 - 90 mg/d x 4 weeks ) in doses sufficient to achieve circulating plasma levels observed in younger healthy individuals . Depression ratings , as well as aspects of memory performance significantly improved . One treatment-resistant patient received extended treatment with DHEA for 6 months : her depression ratings improved 48 - 72 % and her semantic memory performance improved 63 % . These measures returned to baseline after treatment ended . In both studies , improvements in depression ratings and memory performance were directly related to increases in plasma levels of DHEA and DHEA-S and to increases in their ratios with plasma cortisol levels . These preliminary data suggest DHEA may have antidepressant and promemory effects and should encourage double-blind trials in depressed patients There are few reported data on biochemical and functional correlates of and rogen levels in African-American men . This study aim ed at reporting physical and biochemical correlates of serum total testosterone ( total T ) , bioavailable testosterone ( BT ) and dehydroepi and rosterone-sulphate ( DHEAS ) levels in community-dwelling , African-American men aged 50 - 65 years . Home-based physical examinations and health status question naires were administered to r and omly sample d men . Body composition ( dual-energy X-ray absorptiometry ) , lower limb and h and -grip muscle strength , and neuropsychological functions were assessed . Levels of serum total T , BT , DHEAS , oestradiol ( E2 ) , adiponectin , leptin , triglycerides and glucose were measured . Multiple linear regression models were constructed to identify factors independently associated with and rogen levels . DHEAS levels declined from age 50 to 65 years ( p < 0.0001 ) , but total T and BT levels remained constant . Independent of other associated factors , higher total T levels were associated with lower serum triglyceride levels ( beta = -0.142 , p = 0.049 ) ; higher BT was associated with better performance on the trail-making tests ( TMT-B : TMT-A ratio : beta = -0.118 , p = 0.024 ) and higher DHEAS levels were associated with lower adiponectin ( beta = -0.293 , \n Output:\n " }, { "from": "agent", "value": "Other positive correlations between DHEA-S and working memory , attention and verbal fluency were found only in women .\nThe DHEA effect on cognition is limited to one study conducted among young men with high-doses" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: We here report nine liver cirrhosis ( LC ) patients that underwent autologous bone marrow cell infusion ( A BMI ) from the peripheral vein . Subjects were patients with LC with total bilirubin of less than 3.0 mg/dl , platelet count of more than 5 ( 10(10)/l ) , and no viable hepatocellular carcinoma on diagnostic imaging . Autologous bone marrow ( BM ; 400 ml ) was isolated from the ilium under general anesthesia . Mononuclear cells ( MNCs ) were separated by cell washing and were infused via the peripheral vein . MNC characteristics were confirmed by fluorescence-activated cell sorting analysis ( CD34 , CD45 , and c-kit ) . After A BMI therapy , liver function was monitored by blood examination for 24 weeks . From 400 ml of BM , we obtained 7.81 + /- 0.98 x 10(9 ) MNCs . After washing , 5.20 + /- 0.63 x 10(9 ) MNCs were infused into patients with LC . Significant improvements in serum albumin levels and total protein were observed at 24 weeks after A BMI therapy ( p < .05 ) . Significantly improved Child-Pugh scores were seen at 4 and 24 weeks ( p < .05 ) . alpha-Fetoprotein and proliferating cell nuclear antigen ( PCNA ) expression in liver biopsy tissue was significantly elevated after A BMI therapy ( p < .05 ) . No major adverse effects were noted . In conclusion , A BMI therapy should be considered as a novel treatment for patients with decompensated LC OBJECTIVES : Severe alcoholic hepatitis has high short-term mortality . The aim of this study was to test the hypothesis that treatment of patients with alcoholic hepatitis with granulocyte colony-stimulating factor ( G-CSF ) might mobilize bone marrow – derived stem cells and promote hepatic regeneration and thus improve survival . METHODS : Forty-six patients with severe alcoholic hepatitis were prospect ively r and omized in an open study to st and ard medical therapy ( SMT ) plus G-CSF ( group A ; n=23 ) at a dose of 5 μg/kg subcutaneously every 12 h for 5 consecutive days or to SMT alone ( group B ; n=23 ) at a tertiary care center . We assessed the mobilization of CD34 + cells on day 6 , Child-Turcotte-Pugh ( CTP ) , model for end-stage liver disease ( MELD ) , and modified Maddrey ’s discriminant function ( mDF ) scores , and survival until day 90 . RESULTS : There was a statistically significant increase in the number of CD34 + cells in peripheral blood in group A as compared with group B ( P=0.019 ) after 5 days of G-GSF therapy . There was a significant reduction in median Δ change% in CTP , MELD , and mDF at 1 , 2 , and 3 months in group A as compared with group B ( P<0.05 ) . There was marked improvement in survival in group A as compared with group B ( 78.3 % vs. 30.4 % ; P=0.001 ) at 90 days . CONCLUSIONS : G-CSF is safe and effective in the mobilization of hematopoietic stem cells and improves liver function as well as survival in patients with severe alcoholic hepatitis BACKGROUND Cirrhosis , the end stage of progressive hepatic fibrosis , is characterized by distortion of the hepatic architecture and the formation of regenerative nodules . Liver transplantation is one of the few available therapies for such patients . However , due to a severe shortage of organ donors , surgical complications , transplant rejection and the high cost of this procedure much interest has focused on research to find new treatment modalities for this disease . There is accumulating evidence for the contribution of bone marrow stem cells to participate in liver regeneration . METHODS Here we report on six patients with end stage liver disease who were subjected to intraportal administration of autologous bone marrow-derived CD133(+ ) in comparison to mononuclear cells in short-term ( 6 months ) and long-term ( 24 months ) follow up . RESULTS There were no adverse effects in any of the patients during the short- and long-term follow up period . Moreover , there were no significant alterations of liver function parameters , liver enzymes , serum albumin , creatinine , serum bilirubin and /or liver volume after transplantation of both types of autologous cells in these patients . CONCLUSION Our study has shown both the safety and feasibility of this type of liver cell therapy and may be a bridge to liver transplantation . The trial was registered with NIH clinical trials ( www . clinical trials.gov ) as identifier : NCT00713934 OBJECTIVES : Recent advances in regenerative medicine , including hematopoietic stem cell ( HSC ) transplantation , have brought hope for patients with severe alcoholic liver cirrhosis ( ALC ) . The aim of this study was to assess the safety and efficacy of administering autologous exp and ed mobilized adult progenitor CD34 + cells into the hepatic artery of ALC patients and the potential improvement in the liver function . METHODS : Nine patients with biopsy-proven ALC , who had abstained from alcohol for at least 6 months , were recruited into the study . Following granulocyte colony-stimulating factor ( G-CSF ) mobilization and leukapheresis , the autologous CD34 + cells were exp and ed in vitro and injected into the hepatic artery . All patients were monitored for side effects , toxicities , and changes in the clinical , hematological , and biochemical parameters . RESULTS : On average , a five-fold expansion in cell number was achieved in vitro , with a mean total nucleated cell count ( TNCC ) of 2.3 × 108 pre infusion . All patients tolerated the procedure well , and there were no treatment-related side effects or toxicities observed . There were significant decreases in serum bilirubin ( P < 0.05 ) 4 , 8 , and 12 wk post infusion . The levels of alanine transaminase ( ALT ) and aspartate transaminase ( AST ) showed improvement through the study period and were significant ( P < 0.05 ) 1 wk post infusion . The Child-Pugh score improved in 7 out of 9 patients , while 5 patients had improvement in ascites on imaging . CONCLUSION : It is safe to mobilize , exp and , and reinfuse autologous CD34 + cells in patients with ALC . The clinical and biochemical improvement in the study group is encouraging and warrants further clinical trials AIM To assess the utility of an autologous CD34(+ ) and CD133(+ ) stem cells infusion as a possible therapeutic modality in patients with end-stage liver diseases . METHODS One hundred and forty patients with end-stage liver diseases were r and omized into two groups . Group 1 , comprising 90 patients , received granulocyte colony stimulating factor for five days followed by autologous CD34(+ ) and CD133(+ ) stem cell infusion in the portal vein . Group 2 , comprising 50 patients , received regular liver treatment only and served as a control group . RESULTS Near normalization of liver enzymes and improvement in synthetic function were observed in 54.5 % of the group 1 patients ; 13.6 % of the patients showed stable states in the infused group . None of the patients in the control group showed improvement . No adverse effects were noted . CONCLUSION Our data showed that a CD34(+ ) and CD133(+ ) stem cells infusion can be used as supportive treatment for end-stage liver disease with satisfactory tolerability BACKGROUND / AIMS To evaluate feasibility , safety and pattern of bone marrow-derived cells ( BMC ) mobilization in patients with end stage liver cirrhosis following granulocyte-colony stimulating factor ( G-CSF ) administration . METHODS Eight patients with severe liver cirrhosis ( Child-Pugh score B-C , spleen diameter less than 170 mm ) were included . They were treated with G-CSF ( 5 microg/kg b.i.d for three consecutive days ) to mobilize BMC , evaluated as circulating CD34+ve cells ( flow cytometry ) and myeloid CFU-GM progenitors ( in vitro colony growth assay ) . Co-expression in CD34+ve cells markers of differentiation ( Thy1 , CD133 , CXCR4 , c1qRp ) were investigated on CD34+ve cells by double direct immunofluorescence . Data from 40 healthy haematopoietic stem cell donors were used as controls . RESULTS Mobilization of CD34+ve cells occurred in all patients . It was paralleled by expansion of circulating CFU-GM progenitors . Circulating CD34+ve cells co-expressed epithelial and stem cell markers in both cirrhotics and volunteer stem cell donors . G-CSF was well tolerated , no adverse event occurred , a significant reversible increase of splenic longitudinal diameter was observed . CONCLUSIONS ( i ) G-CSF mobilization of BMC co-expressing epithelial and stem markers occurred in all cirrhotic patients ; ( ii ) splenomegaly up to 170 mm does not prevent safe BMC mobilization following G-CSF in patients with end stage liver disease ; ( iii ) mobilized BMC may represent an easy immature cell source potentially useful for novel approaches for liver regeneration BACKGROUND & AIMS A consensus has been reached that liver donor allocation should be based primarily on liver disease severity and that waiting time should not be a major determining factor . Our aim was to assess the capability of the Model for End-Stage Liver Disease ( MELD ) score to correctly rank potential liver recipients according to their severity of liver disease and mortality risk on the OPTN liver waiting list . METHODS The MELD model predicts liver disease severity based on serum creatinine , serum total bilirubin , and INR and has been shown to be useful in predicting mortality in patients with compensated and decompensated cirrhosis . In this study , we prospect ively applied the MELD score to estimate 3-month mortality to 3437 adult liver transplant c and i date s with chronic liver disease who were added to the OPTN waiting list at 2A or 2B status between November , 1999 , and December , 2001 . RESULTS In this study cohort with chronic liver disease , 412 ( 12 % ) died during the 3-month follow-up period . Waiting list mortality increased directly in proportion to the listing MELD score . Patients having a MELD score < 9 experienced a 1.9 % mortality , whereas patients having a MELD score > or = 40 had a mortality rate of 71.3 % . Using the c-statistic with 3-month mortality as the end point , the area under the receiver operating characteristic ( ROC ) curve for the MELD score was 0.83 compared with 0.76 for the Child-Turcotte-Pugh ( CTP ) score ( P < 0.001 ) . CONCLUSIONS These data suggest that the MELD score is able to accurately predict 3-month mortality among patients with chronic liver disease on the liver waiting list and can be applied for allocation of donor livers AIM To evaluate safety and feasibility of autologous bone marrow-enriched CD34 + hematopoietic stem cell Tx through the hepatic artery in patients with decompensated cirrhosis . METHODS Four patients with decompensated cirrhosis were included . Approximately 200 mL of the bone marrow of the patients was aspirated , and CD34 + stem cells were selected . Between 3 to 10 million CD34 + cells were isolated . The cells were slowly infused through the hepatic artery of the patients . RESULTS Patient 1 showed marginal improvement in serum albumin and no significant changes in other test results . In patient 2 prothrombin time was decreased ; however , her total bilirubin , serum creatinine , and Model of End-Stage Liver Disease ( MELD ) score worsened at the end of follow up . In patient 3 there was improvement in serum albumin , porthrombin time ( PT ) , and MELD score . Patient 4 developed radiocontrast nephropathy after the procedure , and progressed to type 1 hepatorenal syndrome and died of liver failure a few days later . Because of the major side effects seen in the last patient , the trial was prematurely stopped . CONCLUSION Infusion of CD34 + stem cells through the hepatic artery is not safe in decompensated cirrhosis . Radiocontrast nephropathy and hepatorenal syndrome could be major side effects . However , this study does not preclude infusion of CD34 + stem cells through other routes \n Output:\n " }, { "from": "agent", "value": "Discussion This systematic review will identify the available evidence on the effectiveness of cell therapies in patients with CLD and in ACLF subgroup ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIM To evaluate the feasibility , safety , and tolerance of early removing gastrointestinal decompression and early oral feeding in the patients undergoing surgery for colorectal carcinoma . METHODS Three hundred and sixteen patients su bmi tted to operations associated with colorectostomy from January 2004 to September 2005 were r and omized to two groups : In experimental group ( n=161 ) , the nasogastric tube was removed after the operation from 12 to 24 h and was promised immediately oral feeding ; In control group ( n=155 ) , the nasogastric tube was maintained until the passage of flatus per rectum . Variables assessed included the time to first passage of flatus , the time to first passage of stool , the time elapsed postoperative stay , and postoperative complications such as anastomotic leakage , acute dilation of stomach , wound infection and dehiscense , fever , pulmonary infection and pharyngolaryngitis . RESULTS The median and average days to the first passage of flatus ( 3.0+/-0.9 vs 3.6+/-1.2 , P<0.001 ) , the first passage of stool ( 4.1+/-1.1 vs 4.8+/-1.4 , P<0.001 ) and the length of postoperative stay ( 8.4+/-3.4 vs 9.6+/-5.0 , P<0.05 ) were shorter in the experimental group than in the control group . The postoperative complications such as anastomotic leakage ( 1.24 % vs 2.58 % ) , acute dilation of stomach ( 1.86 % vs 0.06 % ) and wound complications ( 2.48 % vs 1.94 % ) were similar in the groups , but fever ( 3.73 % vs 9.68 % , P<0.05 ) , pulmonary infection ( 0.62 % vs 4.52 % , P<0.05 ) and pharyngolaryngitis ( 3.11 % vs 23.23 % , P<0.001 ) were much more in the control group than in the experimental group . CONCLUSION The present study shows that application of gastrointestinal decompression after colorectostomy can not effectively reduce postoperative complications . On the contrary , it may increase the incidence rate of fever , pharyngolaryngitis and pulmonary infection . These strategies of early removing gastrointestinal decompression and early oral feeding in the patients undergoing colorectostomy are feasible and safe and associated with reduced postoperative discomfort and can accelerate the return of bowel function and improve rehabilitation Background Postoperative nausea and vomiting is one of the most common complications affecting patients after surgery and causes significant morbidity and increased length of hospital stay . It is accepted that patients undergoing surgery on the bowel are at a higher risk . In the current era of minimally invasive colorectal surgery combined with enhanced recovery , reducing the incidence and severity of postoperative nausea and vomiting is particularly important . Dexamethasone is widely , but not universally used . It is known to improve appetite and gastric emptying , thus reduce vomiting . However , this benefit is not established in patients undergoing bowel surgery , and dexamethasone has possible side effects such as increased risk of wound infection and anastomotic leak that could adversely affect recovery . Design DREAMS is a phase III , double-blind , multicenter , r and omized controlled trial with the primary objective of determining if preoperative dexamethasone reduces postoperative nausea and vomiting in patients undergoing elective gastrointestinal resections . DREAMS aims to r and omize 1,350 patients over 2.5 years . Patients undergoing laparoscopic or open colorectal resections for malignant or benign pathology are r and omized between 8 mg intravenous dexamethasone and control ( no dexamethasone ) . All patients are given one additional antiemetic at the time of induction , prior to r and omization . Both the patient and their surgeon are blinded as to the treatment arm . Secondary objectives of the DREAMS trial are to determine whether there are other measurable benefits during recovery from surgery with the use of dexamethasone , including quicker return to oral diet and reduced length of stay . Health-related quality of life , fatigue and risks of infections will be investigated . Trial registration IS RCT OBJECTIVE : This prospect i ve r and omized clinical study was conducted to evaluate the safety and tolerability of early oral feeding after colorectal operations . METHODS : A total of 199 patients underwent colorectal surgery and were r and omly assigned to early feeding ( n = 99 ) or a regular diet ( n = 100 ) . Patients ' characteristics , diagnoses , surgical procedures , comorbidity , bowel movements , defecation , nasogastric tube reinsertion , time of tolerance of solid diet , complications , and length of hospitalization were assessed . RESULTS : The two groups were similar in terms of gender , age , diagnosis , surgical procedures , and comorbidity . In the early feeding group , 85.9 % of patients tolerated the early feeding schedule . Bowel movements ( 1.7±0.89 vs. 3.27±1.3 ) , defecation ( 3.4±0.77 vs. 4.38±1.18 ) and time of tolerance of solid diet ( 2.48±0.85 vs. 4.77±1.81 ) were significantly earlier in the early feeding group . There was no change between the groups in terms of nasogastric tube reinsertion , overall complication or anastomotic leakage . Hospitalization ( 5.55±2.35 vs. 9.0±6.5 ) was shorter in the early feeding group . CONCLUSIONS : The present study indicated that early oral feeding after elective colorectal surgery was not only well tolerated by patients but also affected the postoperative outcomes positively . Early postoperative feeding is safe and leads to the early recovery of gastrointestinal functions Background : The current trend in postoperative nutrition is to promote a normal oral diet as early as possible . However , postoperative ileus is a frequent and common problem after major abdominal surgery . This study was design ed to investigate whether early enteral nutrition ( EEN ) , as a bridge to a normal diet , can reduce postoperative ileus . Methods : Patients undergoing major rectal surgery for locally advanced primary or recurrent rectal carcinoma ( after neoadjuvant (chemo)-radiation , with or without intraoperative radiotherapy ) were r and omly assigned to EEN ( n = 61 ) or early parenteral nutrition ( EPN , n = 62 ) in addition to an oral diet . Early nutrition was started 8 hours after surgery . Early parenteral nutrition was given as control nutrition to obtain caloric equivalence and minimize confounding . The primary endpoint was time to first defecation ; secondary outcomes were morbidity , other ileus symptoms , and length of hospital stay . Results : Baseline characteristics were similar for both groups . In intention-to-treat analysis , the time to first defecation was significantly shorter in the enteral nutrition arm than in the control arm ( P = 0.04 ) . Moreover , anastomotic leakage occurred significantly less frequently in the enteral group ( 1 patient ) compared with parenteral supplementation ( 9 patients , P = 0.009 ) . Mean length of stay in the enteral group was 13.4 ± 2.2 days versus 16.7 ± 2.3 days in the parenteral group ( P = 0.007 ) . Conclusions : Early enteral nutrition is safe and associated with significantly less ileus . Early enteral nutrition is associated with less anastomotic leakage in patients undergoing extensive rectal surgery BACKGROUND This study assesses the safety outcome of early oral feeding and reports on the factors affecting early postoperative feeding after colorectal procedures . PATIENTS AND METHODS Between June 2005 and April 2008 , 120 consecutive patients underwent elective colonic anastomosis and were then r and omized into two groups . The early feeding group began fluids on the first postoperative day while the regular feeding group was managed in the traditional way - nothing by mouth until the resolution of ileus . RESULTS The majority of patients ( 75 % ) tolerated the early feeding . The times to first passage of flatus ( 3.3+/-0.9 days vs 4.2+/-1.2 days ) and stool ( 4.1+/-1.2 days vs 4.9+/-1.2 days ) were significantly quicker in group 1 . Hospital stay was also significantly shorter in the early feeding group ( 6.2+/-0.2 days vs 6.9+/-0.5 days ) . Operative time and amount of blood loss had an impact on the tolerability of early feeding while age , gender , type of operation and previous abdominal operation had no such impact . CONCLUSION Early oral feeding after colorectal surgery is safe and tolerated by the majority of patients . Operative time and amount of blood loss do , however , have an impact on the tolerability of early feeding Background : Nasogastric ( NG ) intubation is widely used following elective abdominal operations although it is associated with morbidity and discomfort . The present study is a r and omised controlled trial on the effect of early oral feeding without NG decompression following elective colorectal resection for cancer Background We have proposed a simplified perioperative rehabilitation program for elective colonic surgery that is focused on early oral nutrition and that could reduce hospital stay and postoperative ileus time without raising complications and readmission rates . Patients and methods Fifty-four patients admitted for elective colonic surgery were prospect ively r and omized into two groups : ( 1 ) an early feeding group (EFG)—on the first postoperative day , patients initially received a oral liquid diet and were advanced to a regular diet within the next 24 h as tolerated and at their discretion ; ( 2 ) a traditional care group— patients were managed by nothing per orus until the elimination of the first flatus and then su bmi tted to an oral liquid diet , followed by a regular diet within the next 24 h as described for the EFG . All patients followed a well-defined , simplified rehabilitation program . Results Patients ' baseline characteristics were similar in the two groups . Hospital stay was significantly lower in the EFG ( 4.0 [ ±3.7 ] versus 7.6 [ ±8.1 ] days ; p = 0.000 ) . Diet tolerance and progression were similar between groups . Time to first flatus after surgery was significantly lower in the EFG ( 1.5 [ ±0.5 ] versus 2.0 [ ±0.7 ] days ; p = 0.019 ) . Complication and readmission rates were similar in both groups . Conclusions Early oral nutrition associated with a simplified perioperative rehabilitation program reduces postoperative length of hospital stay and ileus time after elective colonic resection without increasing rates of complications or readmissions Postoperative convalescence is mainly determined by the extent and duration of postoperative ileus . This r and omized clinical trial evaluated the effects of early oral feeding on functional gastrointestinal recovery and quality of life BACKGROUND AND AIMS Early enteral nutrition ( EEN ) after surgery should be preferred to parenteral feeding , but its clinical use is limited for concerns about possible gastrointestinal ( GI ) adverse effects and feeding tube-related complications . Thus we evaluated our experience focusing on safety and tolerance of early postoperative jejunal feeding and possible risk factors for gastrointestinal adverse effects . METHODS 650 subjects treated with EEN after major digestive surgery for cancer were prospect ively studied . EEN was started within 12 hours after operation via a naso-jejunal ( NJ ) feeding tube or a catheter-feeding jejunostomy . The rate of infusion was progressively increased to reach the nutritional goal ( 25 kcal/kg/day ) within the 4th postoperative day . Rigorous treatment protocol s for diet delivery and EEN-related GI adverse effects were applied . RESULTS 402 patients had a jejunostomy and 248 patients a NJ tube . EEN-related GI adverse effects were observed in 194/650 patients ( 29.8 % ) . In 136/194 patients , these events were successfully h and led by treatment protocol s. Overall the nutritional goal was achieved in 592/650 patients ( 91.1 % ) . Fifty-eight ( 8.9 % ) subjects had to be switched to parenteral feeding because of refractory intolerance to EEN . Intra-abdominal surgical complications and low serum albumin ( < 30 g/L ) were the two major factors affecting tolerance . Severe jejunostomy-related complications occurred in 7/402 ( 1.7 % ) patients . EEN-related mortality was 0.1 % ( 1/650 ) . CONCLUSIONS The use of the gut early after surgery is safe and well-tolerated and it should represent the first choice for nutritional support in this type of patients Abstract Background Postoperative bowel paralysis is common after abdominal operations , including colectomy . As a result , hospitalization may be prolonged , thereby leading to increased cost . A recent r and omized controlled trial showed that the consumption of regular black coffee after colectomy is associated with a significantly faster resumption of intestinal motility . The mechanism by which coffee stimulates intestinal motility is unknown , but caffeine seems to be the most likely stimulating agent . Thus , the effect of caffeine on postoperative bowel activity after colon surgery will be analyzed in this trial , herein referred to as CaCo . Methods / design Pat \n Output:\n " }, { "from": "agent", "value": "Any form of early postoperative diet provided into the GIT early after colorectal surgery is likely to stimulate gut motility , result ing in earlier return of bowel function and shorter length of stay" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Tissue damage during surgery induces coagulation factors and activates platelets . Surgical pain may provoke release of catecholamines , leading to hypercoagulability . We have investigated the effect of surgical pain on blood coagulability and fibrinolysis in orthopaedic operations using tourniquets in 22 patients undergoing total knee replacement . Patients were allocated to one of two groups to receive extradural anaesthesia ( EA ; n = 11 ) or general anaesthesia ( GA ; n = 11 ) . The EA group received lumbar extradural block with lidocaine . The GA group received only general anaesthesia , maintained with 1.5 - 2.5 % sevoflurane and 66 % nitrous oxide in oxygen . Using a thrombelastogram technique , blood coagulability and fibrinolysis were measured . Mean maximum amplitude ( MA ) , which reflects coagulability , increased after tourniquet inflation ( 11 % ) in group GA whereas MA in group EA did not change . After tourniquet deflation , MA values in both GA and EA groups increased significantly ( 10 % and 20 % , respectively ) ( P < 0.05 ) , and there was also a significant difference in MA between groups ( P < 0.05 ) . The fibrinolytic rate did not change in either group during tourniquet inflation , but increased significantly ( 160 % ) after tourniquet deflation . There was no significant difference in fibrinolytic rate between the groups . We conclude that the hypercoagulability seen in group GA could have been caused by surgical or tourniquet pain , or both , and that extradural anaesthesia is a useful technique to prevent hypercoagulability This study compared the effects of general and regional anesthesia on cognitive and psychosocial functioning in elderly persons . Sixty-four patients between 60 and 86 yr of age undergoing knee arthroplasty were r and omly assigned to receive either general or regional anesthesia . A battery of psychometric tests , including the Satz-Mogel form of the Wechsler Adult Intelligence Scale-Revised , the Wechsler Memory Scale-Revised and the Sickness Impact Profile , and various neuropsychological measures were administered by a blinded observer just before surgery and again 3 months later . Analyses of covariance revealed improvements in most measures that were equivalent between groups . The results indicated that there were no cognitive or psychosocial effects of general or regional anesthesia after 3 months in elderly persons undergoing knee arthroplasty . In this patient population , general anesthesia poses no more risk to long-term mental function than regional anesthesia We have studied the effect of extradural analgesia on postoperative venous thrombosis in patients undergoing knee arthroplasty . Forty-eight patients were allocated r and omly to receive either general anaesthesia or extradural analgesia with local anaesthetics for 3 days . All patients wore compressive elastic stockings and no anticoagulant drugs were administered . Bilateral venography was performed 10 days after surgery . Continuous extradural analgesia did not impede mobilization of the patients . One case of nonfatal pulmonary embolism occurred in a patient who received general anaesthesia . The use of continuous extradural analgesia result ed in a significant difference in the total incidence of deep vein thrombosis ( 18 % compared with 59 % after general anaesthesia ( P = 0.02 ] . The incidence of calf vein thrombosis was 12 % compared with 45 % after general anaesthesia ( P = 0.05 ) Seventy-two patients were r and omized into a prospect i ve clinical trial to evaluate the effects of epidural ( EA ) versus general anesthesia ( GA ) on the incidence of thromboembolic disease ( TED ) following total knee arthroplasty ( TKA ) . Males received aspirin 650 mg po bid and females low-dose warfarin daily to maintain the prothrombin time at 15 to 16 seconds for pharmacologic prophylaxis against TED . Thirty-four patients had EA and 38 GA for their primary TKA . Contrast venography and ventilation-perfusion scanning were performed on the sixth , seventh , and eighth postoperative days , and these were interpreted in a blinded fashion . The mean age of the 45 males and 27 females was 64 years ( range , 42 - 84 years ) . There were no significant differences between the two groups with respect to hematocrit , operative time , blood loss , number of units transfused , or hospital stay . Twelve of the 34 patients ( 35 % ) receiving an EA and 10 of the 38 patients ( 26 % ) receiving GA developed TED , an overall incidence of 31 % ( p greater than 0.05 ) Fifty-three percent of the clots were located in the popliteal vein above the trifurcation or more proximal . However , the incidence of proximal vein thrombosis was significantly less in patients receiving an EA ( 46 % ) rather than a GA ( 64 % ) . The incidence and distribution of clots was not affected by the type of pharmacologic prophylaxis , gender , or use of methylmethacrylate . Ten percent of the patients had a positive scan by strict criteria and were thought to have a pulmonary embolism ( PE ) . In patients with a femoral vein clot , the incidence of PE was 67 % . One bleeding complication occurred in a patient who took double the appropriate warfarin dose . ( ABSTRACT TRUNCATED AT 250 WORDS Background Mood states during epidural opioids are not known . The authors studied the change in mood during the 48‐h period of epidural morphine and epidural fentanyl in 47 patients after elective hip or knee joint arthroplasty . Methods An epidural catheter was inserted at the L2‐L3 or L3‐L4 interspace . Anesthesia was induced with thiopenthal and maintained with isoflurane and nitrous oxide . One hour before the conclusion of the operation , patients received an epidural bolus injection of 2 mg morphine ( n = 23 ) or 100 micro gram fentanyl ( n = 24 ) , followed by the same opiate ( 125 micro gram/ml morphine or 25 micro gram/ml fentanyl ) epidurally delivered by a patient‐controlled analgesia ( PCA ) pump in the postoperative period for 48 h. Mood was assessed using the bipolar form of the Profile of Mood States before operation and 24 h , 48 h , and 72 h after operation . Results There was no significant difference in pain intensity between the groups during epidural PCA . Mood states became more positive over time in the patients who received morphine ( P < 0.01 at 48 h ) and negative in those who were given fentanyl ( P < 0.01 at 24 and 48 h , respectively ) compared with those before the operation , and they were more positive in the morphine than in the fentanyl group at 24 h , 48 h ( P < 0.05 ) , and 72 h ( P < 0.01 ) . Patients in the morphine group were more composed , agreeable , elated , confident , energetic , and clearheaded than were those in the fentanyl group ( P < 0.05 ) . There was no correlation between mood scores and pain scores in either group . There was an inverse correlation at 48 h between mood scores and plasma fentanyl concentrations ( r = ‐0.58 , P < 0.05 ) . Conclusion Mood states are significantly more positive during epidural morphine PCA than they are during epidural fentanyl PCA Background : Both epidural analgesia and intravenous patient‐controlled analgesia ( PCA ) have been found efficacious after various types of surgery . We compared the efficacy , safety , side effects and patient satisfaction of these methods in a r and omized double‐blind fashion after elective anterior cruciate ligament reconstruction of the knee The purpose of this study was to determine if intra-articular injection of morphine or bupivacaine significantly decreased postoperative pain as well as the use of intravenous narcotics for pain relief in patients undergoing total knee arthroplasty ( TKA ) . In a prospect i ve , double-blind , r and omized fashion , 105 patients undergoing TKA were divided into the following 4 groups defined by the intra-articular injection they received : group 1 ( n = 27 ) received saline solution , group 2 ( n = 26 ) received morphine sulfate ( 5 mg ) , group 3 ( n = 24 ) received bupivacaine ( 50 mg ) , and group 4 ( n = 28 ) received a combination of morphine sulfate and bupivacaine . The injections were administered immediately after wound closure by the Hemovac drainage tubing that remained clamped for 45 minutes after surgery to allow for absorption . Before surgery and at 2 , 4 , 6 , 24 , and 48 hours after surgery , pain intensity was recorded using a visual analog scale . Postoperative supplemental intravenous morphine and /or meperidine was administered via a patient-controlled analgesia device , and 24-hour drug usage was tabulated . Results were suggestive of a modest short-term reduction in pain scores in the morphine and bupivacaine treatment groups compared with placebo ( saline ) ; however , results were statistically significant only at 4 hours because of the great variability in the pain score data . The total amount of postoperative pain medication used in the first 24 hours after surgery was not statistically significant between the 4 treatment groups . Thus , the results put into question the benefit of postoperative intra-articular administration of morphine or bupivacaine in patients undergoing TKA Postoperative analgesia after two extradural tramadol regimens was compared with that obtained using a st and ard extradural morphine regimen in patients undergoing total knee replacement . Extradural anaesthesia with light general anaesthesia was used . Patients received extradurally either : tramadol 50 mg by bolus injection followed by infusion ( 5mg.h‐1 for 12 h and 2.5mg.h‐1 for a further 12 h ) ( group T50 ) , tramadol 100 mg by bolus injection followed by infusion ( 10 mg.h‐1 for 12 h and 5mg.h‐1 for a further 12 h ) ( group T100 ) or morphine sulphate 2 mg by bolus injection followed by infusion ( 0.2 mg.h‐1 for 12 h and at 0.1 mg.h‐1 for a further 12 h ) ( group M ) . Analgesia was allocated according to a controlled double‐blind design . Visual analogue pain scores were markedly poorer ( p < 0.05 ) and patient‐controlled analgesic consumption was significantly greater ( p < 0.01 ) in the two tramadol groups when compared with the morphine group . The study was discontinued after recruitment of 12 patients , as analgesia was deemed inadequate in those receiving tramadol extradurally . However , further study of this drug may be warranted to examine its effectiveness where postoperative pain is expected to be less severe , and to assess the effect of larger extradural doses and of co‐administration of tramadol and morphine by this route OBJECTIVE --To evaluate the efficacy and safety of two subcutaneous prophylactic regimens for postoperative deep vein thrombosis after total hip replacement . DESIGN -- Prospect i ve open r and omised multicentre trial . SETTING --28 European departments of orthopaedic surgery . INTERVENTION -- All patients had bilateral phlebography 10 days after surgery . 31 patients receiving low molecular weight heparin and 29 receiving unfractionated heparin were excluded from the efficacy analysis for various reasons . PATIENTS --349 patients undergoing total hip replacement between September 1988 and May 1989 . 174 patients received subcutaneously a low molecular weight heparin ( Fraxiparine ) with anti-factor Xa activity of 41 IU/kg/day for three days , then 62 IU/kg/day from day 4 to day 10 . 175 patients received subcutaneous unfractionated heparin at intervals of eight hours ; doses were adjusted to maintain the activated thromboplastin time at two to five seconds above control values . MAIN OUTCOME MEASURE -- Total incidence of deep vein thrombosis and incidence of proximal deep vein thrombosis on bilateral phlebography . RESULTS --The total incidence of deep vein thrombosis was 16 % in patients receiving unfractionated heparin and 12.6 % in patients receiving low molecular weight heparin ( p = 0.45 ) , and the incidence of thrombosis of the proximal veins was 13.1 % and 2.9 % respectively ( p less than 0.001 ) . Four patients receiving unfractionated heparin and one receiving low molecular weight heparin developed pulmonary embolism . The incidence of bleeding complications was low and comparable in the two groups . CONCLUSION --Low molecular weight heparin is at least as effective as unfractionated heparin in preventing deep vein thrombosis and is more effective at preventing thrombosis of the proximal veins in patients undergoing hip replacement . Low molecular weight heparin is not more likely to cause bleeding complications and is simpler to give than unfractionated heparin This prospect i ve , r and omized , double-blind trial evaluated the efficacy of rectal indomethac \n Output:\n " }, { "from": "agent", "value": "The choice of epidural agents may also influence the extent to which epidural analgesia differs from systemic analgesia .\nREVIEW ER 'S CONCLUSIONS Epidural analgesia may be useful for postoperative pain relief following major lower limb joint replacements .\nHowever , the benefits may be limited to the early ( four to six hours ) postoperative period .\nAn epidural infusion of local anesthetic or local anesthetic-narcotic mixture may be better than epidural narcotic alone .\nThe current evidence is insufficient to draw conclusions on the frequency of rare complications from epidural analgesia , postoperative morbidity or mortality , functional outcomes , or length of hospital stay" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract Objectives : To examine the cost of providing hospital at home in place of some forms of inpatient hospital care . Design : Cost minimisation study within a r and omised controlled trial . Setting : District general hospital and catchment area of neighbouring community trust . Subjects : Patients recovering from hip replacement ( n=86 ) , knee replacement ( n=86 ) , and hysterectomy ( n=238 ) ; elderly medical patients ( n=96 ) ; and patients with chronic obstructive airways disease ( n=32 ) . Interventions : Hospital at home or inpatient hospital care . Main outcome measures : Cost of hospital at home scheme to health service , to general practitioners , and to patients and their families compared with hospital care . Results : No difference was detected in total healthcare costs between hospital at home and hospital care for patients recovering from a hip or knee replacement , or elderly medical patients . Hospital at home significantly increased healthcare costs for patients recovering from a hysterectomy ( ratio of geometrical means 1.15 , 95 % confidence interval 1.04 to 1.29 , P=0.009 ) and for those with chronic obstructive airways disease ( Mann-Whitney U test , P=0.01 ) . Hospital at home significantly increased general practitioners ' costs for elderly medical patients ( Mann-Whitney U test , P<0.01 ) and for those with chronic obstructive airways disease ( P=0.02 ) . Patient and carer expenditure made up a small proportion of total costs . Conclusion : Hospital at home care did not reduce total healthcare costs for the conditions studied in this trial , and costs were significantly increased for patients recovering from a hysterectomy and those with chronic obstructive airways disease . There was some evidence that costs were shifted to primary care for elderly medical patients and those with chronic obstructive airways disease . Key messages Hospital at home schemes are a popular alternative to st and ard hospital care , but there is uncertainty about their cost effectiveness In our r and omised controlled trial we compared the cost of hospital at home care with that of inpatient hospital care for patients recovering from hip replacement , knee replacement , and hysterectomy ; elderly medical patients ; and those with chronic obstructive airways disease There were no major differences in health service costs between the two arms of the trial for patients recovering from hip or knee replacement and elderly medical patients Hospital at home care increased healthcare costs for patients recovering from hysterectomy and for those with chronic obstructive airways disease Hospital at home care result ed in some costs shifting to general practitioners for elderly medical patients and those with chronic obstructive airways OBJECTIVE : To test the cost effectiveness of Hospital in the Home compared to hospital admission for acute medical conditions BACKGROUND We have previously reported the use of a hospital based respiratory nurse service ( Acute Respiratory Assessment Service , ARAS ) to support home treatment of patients with exacerbations of chronic obstructive pulmonary disease ( COPD ) . A controlled trial was undertaken to compare early discharge with home treatment supported by respiratory nurses with conventional hospital management of patients admitted with exacerbations of COPD . METHODS Patients with COPD admitted as emergencies were identified the next working day . They were eligible for inclusion in the study if the differential diagnosis included an exacerbation of COPD , but were excluded if other medical conditions or acidotic respiratory failure required inpatient investigation or management . Of 360 patients review ed , 209 were being assessed for other active medical problems and were excluded , 33 potential participants were already involved in research studies and so were ineligible , and 37 did not wish to participate in the study . Eighty one patients were r and omised to receive conventional inpatient care ( n=40 ) or to planned early discharge the next working day ( n=41 ) . Those discharged early continued treatment at home under the supervision of specialist respiratory nurses . Outcome measures were readmission , additional hospital days , and deaths within 60 days of initial admission . Process measures included number of visits , duration of follow up by the respiratory nurse , and additional treatment provided to support early discharge . RESULTS On an intention to treat basis , a policy of early discharge reduced inpatient stay from a mean of 6.1 ( range 1–13 ) days with conventional management to 3.2 ( 1–16 ) days with an early discharge policy . Twelve patients ( 30 % conventional management , 29.3 % early discharge ) were readmitted in each group giving a mean difference in readmission of 0.7 % ( 95 % CI of the difference –19.2 to 20.6 ) . In the conventional management group readmitted patients spent a mean of 8.75 additional days in hospital compared with 7.83 days in the early discharge group , giving a mean difference of 0.92 days ( 95 % CI of the difference –6.5 to 8.3 ) . There were two deaths ( 5 % ) in the conventional management group and one ( 2.4 % ) in the early discharge group , a mean difference of 2.6 % ( 95 % CI of the difference –5.7 to 10.8 ) . CONCLUSIONS Patients with acute exacerbations of COPD uncomplicated by acidotic respiratory failure or other medical problems can be discharged home earlier than is current practice with support by visiting respiratory nurses . No difference was found in the subsequent need for readmission BACKGROUND Patients with acute proximal deep-vein thrombosis are usually treated first in the hospital with intravenous st and ard ( unfractionated ) heparin . However , the longer plasma half-life , better bioavailability after subcutaneous administration , and more predictable anticoagulant response of low-molecular-weight heparins make them attractive for possible home use . We compared these two approaches . METHODS Patients with acute proximal deep-vein thrombosis were r and omly assigned to receive either intravenous st and ard heparin in the hospital ( 253 patients ) or low-molecular-weight heparin ( 1 mg of enoxaparin per kilogram of body weight subcutaneously twice daily ) administered primarily at home ( 247 patients ) . The study design allowed out patients taking low-molecular-weight heparin to go home immediately and hospitalized patients taking low-molecular-weight heparin to be discharged early . All the patients received warfarin starting on the second day . RESULTS Thirteen of the 247 patients receiving low-molecular-weight heparin ( 5.3 percent ) had recurrent thromboembolism , as compared with 17 of the 253 patients receiving st and ard heparin ( 6.7 percent ; P=0.57 ; absolute difference , 1.4 percentage points ; 95 percent confidence interval , -3.0 to 5.7 ) . Five patients receiving low-molecular-weight heparin had major bleeding , as compared with three patients receiving st and ard heparin . After r and omization , the patients who received low-molecular-weight heparin spent a mean of 1.1 days in the hospital , as compared with 6.5 days for the st and ard-heparin group ; 120 patients in the low-molecular-weight- heparin group did not need to be hospitalized at all . CONCLUSIONS Low-molecular-weight heparin can be used safely and effectively to treat patients with proximal deep-vein thrombosis at home A r and omised controlled trial has been conducted into the effects of discharging patients from hospital either 48 hours or six to seven days after operations for inguinal hernia and varicose veins . There was no statistically significant difference in major postoperative complications between the two lengths of stay for either of the two conditions . Similarly there was no difference between the two groups of hernia patients in relation to eventual recurrences . There was no significant difference in length of convalescence between long-stay and short-stay patients in full-time occupations . The savings to the statutory services of discharging patients early were estimated at 25.72 pounds per patient . Patients appeared to approve of the type of care they experienced , regardless of length of stay . However , the families of short-stay patients were significantly less enthusiastic in their attitudes towards the policy of early discharge than the families of long-stay patients BACKGROUND AND PURPOSE This study describes the methodology , patient outcome , and use of hospital and rehabilitation services at 3 months of a population -based r and omized controlled trial . The purpose was to evaluate rehabilitation at home after early supported discharge from the Department of Neurology , Huddinge Hospital , for moderately disabled stroke patients in southwest Stockholm . METHODS The patients were eligible if they were continent , independent in feeding , had mental function within normal limits , and had impaired motor function and /or aphasia 1 week after stroke . Patients were r and omized either to early supported discharge with continuity of rehabilitation at home for 3 to 4 months or to routine rehabilitation service in a hospital , day care , and /or outpatient care . The home rehabilitation team consisted of two physical therapists , two occupational therapists , and one speech therapist ; one of the therapists was assigned as case manager for the patient . The rehabilitation program at home emphasized a task- and context -oriented approach . The activities were chosen on the basis of the patient 's personal interests . Spouses were offered education and individual counseling . A total of 81 patients were followed up for a minimum of 3 months . Patient outcome was assessed by the Frenchay Social Activity Index , Extended Katz Index , Barthel Index , Lindmark Motor Capacity Assessment , Nine-Hole Peg Test , walking speed over 10 m , reported falls , and subjective dysfunction according to the Sickness Impact Profile . Patient use of hospital and home rehabilitation service and patient satisfaction with care were studied . RESULTS Overall there were no statistical significant differences in outcome . Multivariate logistic regression analysis suggested a systematic positive effect for the home rehabilitation group in social activity , activities of daily living , motor capacity , manual dexterity , and walking . A considerable difference in re source use during such a 3-month period was seen . A 52 % reduction in hospitalization was observed : from 29 days in the routine rehabilitation group to 14 days in the home rehabilitation group . Patient satisfaction was in favor of the latter group . CONCLUSIONS Early supported discharge with continuity of home rehabilitation services for the majority of moderately disabled stroke patients during the first 3-month period after acute stroke is not less beneficial than routine rehabilitation and can be a rehabilitation service of choice if follow-up at 6 and 12 months confirms the suggested effectiveness and considerable reduction in use of health care It was postulated that home hospitalisation ( HH ) of selected chronic obstructive pulmonary disease ( COPD ) exacerbations admitted at the emergency room ( ER ) could facilitate a better outcome than conventional hospitalisation . To this end , 222 COPD patients ( 3.2 % female ; 71±10 yrs ( mean±sd ) ) were r and omly assigned to HH ( n=121 ) or conventional care ( n=101 ) . During HH , integrated care was delivered by a specialised nurse with the patient 's free-phone access to the nurse ensured for an 8‐week follow-up period . Mortality ( HH : 4.1 % ; controls : 6.9 % ) and hospital readmissions ( HH : 0.24±0.57 ; controls : 0.38±0.70 ) were similar in both groups . However , at the end of the follow-up period , HH patients showed : 1 ) a lower rate of ER visits ( 0.13±0.43 versus 0.31±0.62 ) ; and 2 ) a noticeable improvement of quality of life ( Δ St George 's Respiratory Question naire ( SGRQ ) , −6.9 versus −2.4 ) . Furthermore , a higher percentage of patients had a better knowledge of the disease ( 58 % versus 27 % ) , a better self-management of their condition ( 81 % versus 48 % ) , and the patient 's satisfaction was greater . The average overall direct cost per HH patient was 62 % of the costs of conventional care , essentially due to fewer days of inpatient hospitalisation ( 1.7±2.3 versus 4.2±4.1 days ) . A comprehensive home care intervention in selected chronic obstructive pulmonary disease exacerbations appears as cost effective . The home hospitalisation intervention generates better outcomes at lower costs than conventional care To compare the results of home and hospital treatment in men aged under 70 years who had suffered acute myocardial infa rct ion within 48 hours 1895 patients were considered for study in four centres in south-west Engl and . Four-hundred- and -fifty patients were r and omly allocated to receive care either at home by their family doctor or in hospital , initially in an intensive care unit . The r and omised treatment groups were similar in age , history of cardiovascular disease , and incidence of hypotension when first examined . They were followed up for up to a year after onset . The mortality rate at 28 days was 12 % for the r and om home group and 14 % for the r and om hospital group ; the corresponding figures at 330 days were 20 % and 27 % . On average , older patients and those without initial hypotension fared rather better under home care . The patients who underwent r and omisation were similar to those whose place of care was not r and omised , except that the non-r and omised group contained a higher proportion of initially hypotensive patients , whose prognosis was poor wherever treated . These results confirm and extend our preliminary findings . Home care is a proper form of treatment for many patients with acute myocardial infa rct ion , particularly those over 60 years and those with an uncomplicated attack seen by general practitioners BACKGROUND An intravenous course of st and ard ( unfractionated ) heparin with the dose adjusted to prolong the activated partial-thromboplastin time to a desired length is the st and ard initial in-hospital treatment for patients with deep-vein thrombosis , but fixed \n Output:\n " }, { "from": "agent", "value": "Allocation to hospital at home result ed in a small reduction in hospital length of stay , but hospital at home increased overall length of care .\nPatients allocated to hospital at home expressed greater satisfaction with care than those in hospital , while the view of carers was mixed .\nEarly discharge schemes for patients recovering from elective surgery and elderly patients with a medical condition may have a place in reducing the pressure on acute hospital beds , providing the views of the carers are taken into account .\nFor these clinical groups hospital length of stay is reduced , although this is offset by the provision of hospital at home ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : To compare the results of pancreaticogastrostomy versus pancreaticojejunostomy following pancreaticoduodenectomy in a prospect i ve and r and omized setting . Summary Background Data : While several techniques have been proposed for reconstructing pancreatico-digestive continuity , only a limited number of r and omized studies have been carried out . Methods : A total of 151 patients undergoing pancreaticoduodenectomy with soft residual tissue were r and omized to receive either pancreaticogastrostomy ( group PG ) or end-to-side pancreaticojejunostomy ( group PJ ) . Results : The 2 treatment groups showed no differences in vital statistics or underlying disease , mean duration of surgery , and need for intraoperative blood transfusion . Overall , the incidence of surgical complications was 34 % ( 29 % in PG , 39 % in PJ , P = not significant ) . Patients receiving PG showed a significantly lower rate of multiple surgical complications ( P = 0.002 ) . Pancreatic fistula was the most frequent complication , occurring in 14.5 % of patients ( 13 % in PG and 16 % in PJ , P = not significant ) . Five patients in each treatment arm required a second surgical intervention ; the postoperative mortality rate was 0.6 % . PG was favored over PJ due to significant differences in postoperative collection s ( P = 0.01 ) , delayed gastric emptying ( P = 0.03 ) , and biliary fistula ( P = 0.01 ) . The mean postoperative hospitalization period stay was comparable in both groups . Conclusions : When compared with PJ , PG did not show any significant differences in the overall postoperative complication rate or incidence of pancreatic fistula . However , biliary fistula , postoperative collection s and delayed gastric emptying are significantly reduced in patients treated by PG . In addition , pancreaticogastrostomy is associated with a significantly lower frequency of multiple surgical complications OBJECTIVE Pancreatic fistula is a leading cause of morbidity and mortality after pancreaticoduodenectomy . External drainage of pancreatic duct with a stent has been shown to reduce pancreatic fistula rate of pancreaticojejunostomy in a few retrospective or prospect i ve nonr and omized studies , but no r and omized controlled trial has been reported thus far . This single-center prospect i ve r and omized trial compared the results of pancreaticoduodenectomy with external drainage stent versus no stent for pancreaticojejunal anastomosis . METHODS A total of 120 patients undergoing pancreaticoduodenectomy with end-to-side pancreaticojejunal anastomosis were r and omized to have either an external stent inserted across the anastomosis to drain the pancreatic duct ( n = 60 ) or no stent ( n = 60 ) . Duct-to-mucosa anastomosis was performed in all cases . RESULTS The 2 groups were comparable in demographic data , underlying pathologies , pancreatic consistency , and duct diameter . Stented group had a significantly lower pancreatic fistula rate compared with nonstented group ( 6.7 % vs. 20 % , P = 0.032 ) . Radiologic or surgical intervention for pancreatic fistula was required in 1 patient in the stented group and 4 patients in the nonstented group . There were no significant differences in overall morbidity ( 31.7 % vs. 38.3 % , P = 0.444 ) and hospital mortality ( 1.7 % vs. 5 % , P = 0.309 ) . Two patients in the nonstented group and none in the stented group died of pancreatic fistula . Hospital stay was significantly shorter in the stented group ( mean 17 vs. 23 days , P = 0.039 ) . On multivariate analysis , no stenting and pancreatic duct diameter <3 mm were significant risk factors of pancreatic fistula . CONCLUSION External drainage of pancreatic duct with a stent reduced leakage rate of pancreaticojejunostomy after pancreaticoduodenectomy The aim of this prospect i ve study was to clarify differences in postoperative changes of serum or drainage fluid pancreatic amylase levels and serum C-reactive protein ( CRP ) levels between patients with a soft pancreatic texture and those with a hard pancreatic texture undergoing pancreatoduodenectomy ( PD ) with pancreaticogastrostomy . A total of 61 consecutive patients with resectable periampullary tumors undergoing PD were recruited . This population was divided into 27 patients with a hard pancreatic texture and 34 patients with a soft pancreatic texture . Drainage fluid total amylase or pancreatic amylase levels , serum total amylase or pancreatic amylase levels , and serum CRP levels were measured postoperatively . Clinicopathological data were also compared between two groups . Postoperative complications more frequently occurred in patients with a soft pancreatic texture compared with those with a hard pancreatic texture ( P = 0.029 ) . Serum or drainage fluid pancreatic amylase levels and serum CRP levels of patients with a soft pancreatic texture were significantly higher than those of patients with a hard pancreatic texture after PD on postoperative days 1 and 2 ( P < 0.05 ) . A soft pancreatic texture was identified as an only independent predictive factor of increased drainage fluid pancreatic amylase levels ( P = 0.006 ) and serum CRP levels ( P = 0.047 ) . A soft pancreatic texture is closely associated with increased drainage fluid pancreatic amylase and serum CRP levels after PD . More careful post-PD management is needed for patients with a soft pancreatic texture Pancreatic duct stenting remains an attractive strategy to reduce the incidence of pancreatic fistulas following pancreaticoduodenectomy ( PD ) with encouraging results in both retrospective and prospect i ve studies . We performed a prospect i ve r and omized trial to test the hypothesis that internal pancreatic duct stenting reduces the development of pancreatic fistulas following PD . Two hundred thirty-eight patients were r and omized to either receive a pancreatic stent ( S ) or no stent ( NS ) , and stratified according to the texture of the pancreatic remnant ( soft/normal versus hard ) . Four patients were excluded from the study ; in three instances due to a pancreatic duct that was too small to cannulate and in the other instance because a total pancreatectomy was performed . Patients who r and omized to the S group had a 6-cm-long segment of a plastic pediatric feeding tube used to stent the pancreaticojejunostomy anastomosis . In patients with a soft pancreas , 57 r and omized to the S group and 56 r and omized to the NS group . In patients with a hard pancreas , 58 r and omized to the S group and 63 r and omized to the NS group . The S and NS groups for the entire study population , as well as for the subgroup of high-risk patients with soft pancreata , were similar as regard to demographics , past medical history , preoperative symptoms , preoperative procedures , and intraoperative data . The pancreatic fistula rate for the entire study population was 9.4 % . The fistula rates in the S and NS subgroups with hard pancreata were similar , at 1.7 % and 4.8 % ( P=0.4 ) , respectively . The fistula rates in the S and NS subgroups with soft pancreata were also similar , at 21.1 % and 10.7 % ( P=0.1 ) , respectively . A nonstatistically significant increase in the pancreatic fistula rate in the S group persisted after adjusting for the operating surgeon and technical details of the operation ( e.g. , anastomotic technique , anastomotic orientation , pancreatic duct size , and number of intra-abdominal drains placed ) . In patients with soft pancreata , 63 % percent of the pancreatic fistulas in stented patients required adjustment to the clinical pathway ( including two deaths ) , compared to 47 % of the pancreatic fistulas in patients in the NS group ( P=0.3 ) . Internal pancreatic duct stenting does not decrease the frequency or the severity of postoperative pancreatic fistulas Background The aim of this single-center r and omized trial was to compare the perioperative outcome of pancreatoduodenectomy with pancreatogastrostomy ( PG ) vs pancreaticojejunostomy ( PJ ) . Methods R and omization was done intraoperatively . PG was performed via anterior and posterior gastrotomy with pursestring and inverting seromuscular suture ; control intervention was PJ with duct – mucosa anastomosis . The primary endpoint was postoperative pancreatic fistula ( POPF ) . Results From 2006 to 2011 , n = 268 patients were screened and n = 116 were r and omized to n = 59 PG and n = 57 PJ . There was no statistically significant difference regarding the primary endpoint ( PG vs PJ , 10 % vs 12 % , p = 0.775 ) . The subgroup of high-risk patients with a soft pancreas had a non-significantly lower pancreatic fistula rate with PG ( PG vs PJ , 14 vs 24 % , p = 0.352 ) . Analysis of secondary endpoints demonstrated a shorter operation time ( 404 vs 443 min , p = 0.005 ) and reduced hospital stay for PG ( 15 vs 17 days , p = 0.155 ) . Delayed gastric emptying ( DGE ; PG vs PJ , 27 vs 17 % , p = 0.246 ) and intraluminal bleeding ( PG vs PJ , 7 vs 2 % , p = 0.364 ) were more frequent with PG . Mortality was low in both groups ( < 2 % ) . Conclusions Our r and omized controlled trial shows no difference between PG and PJ as reconstruction techniques after partial pancreatoduodenectomy . POPF rate , DGE , and bleeding were not statistically different . Operation time was significantly shorter in the PG group Objective The authors hypothesized that pancreaticogastrostomy is safer than pancreaticojejunostomy after pancreaticoduodenectomy and less likely to be associated with a postoperative pancreatic fistula . Summary Background Data Pancreatic fistula is a leading cause of morbidity and mortality after pancreaticoduodenectomy , occurring in 10 % to 20 % of patients . Nonr and omized reports have suggested that pancreaticogastrostomy is less likely than pancreaticojejunostomy to be associated with postoperative complications . Methods Between May 1993 and January 1995 , the findings for 145 patients were analyzed in this prospect i ve trial at The Johns Hopkins Hospital . After giving their appropriate preoperative informed consent , patients were r and omly assigned to pancreaticogastrostomy or pancreaticojejunostomy after completion of the pancreaticoduodenal resection . All pancreatic anastomoses were performed in two layers without pancreatic duct stents and with closed suction drainage . Pancreatic fistula was defined as drainage of greater than 50 mL of amylase‐rich fluid on or after postoperative day 10 . Results The pancreaticogastrostomy ( n = 73 ) and pancreaticojejunostomy ( n = 72 ) groups were comparable with regard to multiple parameters , including demographics , medical history , preoperative laboratory values , and intraoperative factors , such as operative time , blood transfusions , pancreatic texture , length of pancreatic remnant mobilized , and pancreatic duct diameter . The overall incidence of pancreatic fistula after pancreaticoduodenectomy was 11.7 % ( 17/145 ) . The incidence of pancreatic fistula was similar for the pancreaticogastrostomy ( 12.3 % ) and pancreaticojejunostomy ( 11.1 % ) groups . Pancreatic fistula was associated with a significant prolongation of postoperative hospital stay ( 36 ± 5 vs. 15 ± 1 days ) ( p < 0.001 ) . Factors significantly increasing the risk of pancreatic fistula by univariate logistic regression analysis included ampullary or duodenal disease , soft pancreatic texture , longer operative time , greater intraoperative red blood cell transfusions , and lower surgical volume ( p < 0.05 ) . A multivariate logistic regression analysis revealed the factors most highly associated with pancreatic fistula to be lower surgical volume and ampullary or duodenal disease in the resected specimen . Conclusions Pancreatic fistula is a common complication after pancreaticoduodenectomy , with an incidence most strongly associated with surgical volume and underlying disease . These data do not support the hypothesis that pancreaticogastrostomy is safer than pancreaticojejunostomy or is associated with a lower incidence of pancreatic fistula BACKGROUND Anastomotic failure is still a significant problem that affects the outcome of pancreaticoduodenectomy . There have been many techniques proposed for the reconstruction of pancreatic digestive continuity , but there have been few prospect i ve and r and omized studies that compare their efficacy . METHODS In the current work , 144 patients who underwent a pancreaticoduodenectomy with soft residual tissue were assigned r and omly to receive either a duct-to-mucosa anastomosis ( group A ) or a 1-layer end-to-side pancreaticojejunostomy ( group B ) . RESULTS The 2 treatment groups were found not to have any differences in regards to vital statistics , underlying disease , or operative techniques . The postoper \n Output:\n " }, { "from": "agent", "value": "This meta- analysis suggests that the most effective treatment for reconstruction of pancreatic continuity after pancreatoduodenectomy is pancreaticogastrostomy ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To determine whether macrophage colony-stimulating factor ( M-CSF ) reduces the incidence and duration of febrile neutropenia during three courses of intensive consolidation therapy and whether it shortens time to complete consolidation therapy . PATIENTS AND METHODS In 198 adult patients with acute myeloid leukemia ( AML ) in complete remission ( CR ) , M-CSF ( 8 x 10(6 ) U/d ) or placebo was administered from 1 day after the end of each consolidation chemotherapy for 14 days . RESULTS The duration and incidence of febrile neutropenia was significantly reduced by 34 % ( P = .00285 ) and 17 % ( P = .02065 ) , respectively , in 88 assessable patients in the M-CSF group compared with those in 94 assessable patients in the placebo group . Patients in the M-CSF group had 565 days and 133 episodes of febrile neutropenia during 7,901 days at risk , while patients in the placebo group had 977 days and 185 episodes during 9,077 days at risk . The median period required to finish the three courses of consolidation therapy was 93 days in the M-CSF group , which was significantly shorter than 110 days in placebo group ( P = .0050 ) . In the M-CSF group , the recovery of neutrophils and platelets was significantly faster ( P = .0348 and P = 0.0364 , respectively ) , the administration of systemic antimicrobial agents tended to be less ( P = .0839 ) , and the frequency of platelet transfusion ( P = .0259 ) and the total volume of transfused platelets ( P = .0292 ) were significantly less . However , there was no significant difference in the disease-free survival . CONCLUSION M-CSF significantly reduced the incidence and duration of febrile neutropenia during the intensive consolidation therapy , and shortened the time to complete consolidation chemotherapy in AML Sepsis associated with neutropenia remains a major cause of morbidity and mortality from many chemotherapy regimens . In a recent tabulation of commonly used chemotherapy agents [ 1 ] , 29 of 37 are listed as causing marked or moderate leukopenia . A known correlation exists between the degree and duration of neutropenia and the risk for sepsis [ 2 ] . In conjunction with neutropenia , infections with gram-negative organisms such as Pseudomonas spp . occur relatively frequently and have high morbidity and mortality rates if antibiotic therapy is not begun until infection is microbiologically confirmed [ 3 , 4 ] . Current recommended practice is to initiate empiric , broad-spectrum intravenous antibiotic therapy in all patients with febrile neutropenia at the onset of fever , despite clinical and microbiological evidence of infection being found in only 40 % to 60 % of cases [ 5 ] . In addition to antibiotic therapy , neutrophil recovery is an important factor for a successful treatment outcome in these patients [ 6 , 7 ] and has been identified as the most favorable prognostic factor in a recent multivariate logistic regression analysis of 14 variables analyzed in a study of antibiotic efficacy [ 7 ] . Granulocyte transfusions are logistically difficult , are associated with substantial toxicity , and are of uncertain efficacy [ 8 , 9 ] ; before the availability of the colony-stimulating factors , few pharmacologic agents had clinical utility in increasing neutrophil levels [ 10 ] . Filgrastim ( previously known as recombinant methionyl human granulocyte colony-stimulating factor [ r-metHuG-CSF ] ) is a hematopoietic growth factor that promotes the survival , proliferation , differentiation , and function of progenitor and mature cells of the neutrophil granulocyte lineage [ 11 ] . It has potent granulopoietic effects in vivo [ 12 - 14 ] , and its clinical pharmacology has been defined [ 15 ] . In two phase III studies [ 16 , 17 ] , filgrastim therapy that was started 1 day after chemotherapy reduced the severity and duration of neutropenia and decreased by nearly half the incidence of febrile neutropenic episodes and the average duration of hospitalization and antibiotic use per patient . The use of filgrastim to prevent febrile neutropenic episodes in patients with cancer who receive chemotherapy is now an approved indication in many countries . Not all patients with cancer who have had chemotherapy and who have been treated with filgrastim receive it to reduce the risk for neutropenic sepsis . Approximately 14 % of filgrastim in the United States has been used to treat episodes of postchemotherapy febrile neutropenia after they occur rather than to prevent them ( unpublished market research data , Amgen , Inc. ) . To determine if filgrastim administered in addition to st and ard empiric inpatient antibiotic therapy was also beneficial in patients presenting with established fever and neutropenia , we conducted a multicenter , r and omized , double-blind , placebo-controlled study . This is the first report of a study assessing therapeutic intervention with filgrastim in this clinical setting . Methods We present the analysis of findings from 218 patients enrolled at four centers between October 1988 and February 1992 . The study drug was filgrastim , a recombinant human protein produced in Escherichia coli [ 18 ] and supplied by Amgen , Inc. , Thous and Oaks , California . Patients Eligible patients with febrile neutropenia were adults ( age 16 years ) receiving chemotherapy for histologically confirmed cancer other than myeloid leukemia who had an oral temperature of greater than 38.2 C and a neutrophil count less than 1.0 109/L. The neutrophil count included the number of b and s and polymorphonuclear forms counted in manual differentials from blood smears . Patients were ineligible if they were already receiving antibiotic therapy , if they had septic shock ( a systolic blood pressure of < 90 mm Hg , poor peripheral perfusion , and abnormal mentation ) , if they were receiving myeloablative chemotherapy with marrow transplantation support , if they had severe renal impairment ( serum creatinine level > 0.7 mM ) , abnormal liver function ( bilirubin > 5 times the upper limit of normal ) , were pregnant or breast-feeding , or had a history of allergic reactions to the study antibiotics . Patients could enter the r and omized trial only once . If subsequent episodes of fever and neutropenia developed , patients were offered open-label filgrastim therapy according to the same procedures described in the protocol . Data from these episodes are not included in this report . The study was approved by the relevant institutional review boards of each treatment center , and all patients gave signed informed consent . Study Design Our study was a r and omized , double-blind , placebo-controlled trial . Patients were r and omly assigned to receive either filgrastim or placebo from identically labeled vials . Stratification was not done before r and omization . The r and omization code was maintained by the Biostatistical Department of Amgen , Inc. , and was not broken until all collected data had been verified by Amgen and its design ee , Biomedicus ( Boronia , Australia ) , and had been audited by a separate department at Amgen . Enrolled patients were admitted to the hospital , and a full medical history was taken and physical examination done . Baseline investigations included full blood counts with differential leukocyte counts and chest radiographs . Cultures of blood ( in duplicate ) , urine , and other clinical ly suspicious sites were done . Empiric treatment was started with piperacillin ( 4 g intravenously every 6 hours ) and tobramycin ( 2 mg/kg of body weight intravenously for the loading dose and 80 mg intravenously every 8 hours thereafter ) . Antibiotic dose was adjusted for patient size , renal and hepatic impairment , and drug serum levels according to st and ard criteria . Therapy with filgrastim or placebo was initiated within 12 hours of the start of antibiotic therapy at a dose of 12 g/kg per day by continuous subcutaneous infusion with the use of a portable pump . Filgrastim ( supplied in 5- or 10-mL vials as a clear , colorless solution of 300 g/mL ) or placebo ( supplied in matching vials for double-blinding ) was diluted in a sterile solution of 5 % glucose in water to a volume of 50 mL. Patients remained in the study until 4 consecutive afebrile days ( peak daily temperature , < 37.5 C ) had passed and the blood neutrophil count was greater than 0.5 109/L or until 28 days had elapsed . Filgrastim or placebo doses were reduced or the drugs were withdrawn before study completion if the blood neutrophil count exceeded 10.0 109/L ( dose reduced to 6 g/kg per day ) , 15.0 109/L ( dose reduced to 3 g/kg per day ) , or 20.0 109/L ( drug withdrawn ) . Intravenous antibiotics were administered until study completion , although the actual drugs or doses could be altered at the investigators ' discretion within broad protocol guidelines . Study End Points Our study evaluated the effect of filgrastim on the number of days of fever and on the number of days of neutropenia associated with presumed or documented infection that was treated with antibiotics . Blood counts were done daily , and oral temperatures were recorded at least four times per day . Two end points were defined for days of neutropenia and are specified here as the number of days on which the neutrophil count was less than 0.5 109/L and less than 1.0 109/L. The days of fever end point was defined as the number of consecutive days ( after and including the day of presentation ) on which the maximum oral temperature was 37.5 C or greater , plus any subsequent periods beginning with a day of temperature peak of greater than 38.2 C and ensuing days with peaks of 37.5 C or greater . We also analyzed several related end points . The time to resolution of fever was defined as the number of days elapsed before the first complete day with a temperature less than 37.5 C ( subsequent fevers were not included in this definition ) . Late fever was defined as a temperature greater than 38.2 C occurring after the fever had initially resolved . The time to resolution of febrile neutropenia was defined as the number of days elapsed before the first day with both a temperature less than 37.5 C and a neutrophil count of 1.0 109/L or less ( subsequent days of fever or neutropenia were not included in this definition ) . The prospect ively defined secondary end points of the study were days on study ( hospitalization ) and the incidence of the change of antibiotics . This was an inpatient study ; therefore , all days on study were spent in the hospital . Although some patients were in patients when fever and neutropenia developed and some remained in the hospital after completing the study , the days on study equalled the period of hospitalization for most patients . Patients who remained in the hospital after completing the study did so for reasons other than continued morbidity related to fever and neutropenia . Safety All adverse events were grade d according to World Health Organization criteria [ 19 ] . Data collected included daily clinical evaluation , toxicity grading , and blood examinations ; and urea , electrolytes , creatinine , liver function tests , clotting tests , and urinalysis , all of which were done every fifth day . The numbers of red blood cell and platelet transfusions were also recorded . Deaths that occurred during the study and within 30 days of study completion were recorded , and a blinded assessment was made of any possible contribution to the death by the study drug . Statistical Analyses We used a 1:1 ratio of patients treated with filgrastim to patients receiving placebo . The sample size was chosen to detect a 25 % difference in the protocol -specified primary end points of days of fever and days of neutropenia with 80 % power at a significance level of 0.05 . However , an unplanned interim analysis was done for administrative purpose s , rather than with the intent of early study termination , when 87 patients had completed the study . Therefore , the A Phase I trial was conducted to determine the safety , biological activity , and hematopoietic recovery by the combination of interleukin 6 ( IL-6 ) and granulocyte-colony stimulating factor ( G-CSF ) after myelosuppressive chemotherapy in children . Patients < 22 years of age at diagnosis with either recurrent or refractory solid tumors received ifosfamide 1,800 mg/m2/day x 5 days , carboplatin 400 mg/m2/ day x 2 days , and etoposide 100 mg/m2/day x 5 days , followed by daily s.c . G-CSF ( 5 microg/kg/day ) and IL-6 ( 2.5 , 3.75 , or 5.0 microg/kg/day ) . Pharmacokinetic , proinflammatory mediator levels , hematopoietic colony assays , and cytokine receptor expression studies were performed during course one . Nineteen patients were evaluable for toxicity and received IL-6 at doses of 2.5 ( n = 8) , 3.75 ( n = 5 ) , or 5.0 ( n = 6 ) microg/kg/day . Dose-limiting constitutional toxicity occurred in two of six patients at 5.0 microg/kg/day , two of five patients at 3.75 microg/kg/day , and two of eight patients at 2.5 microg/kg/day . The maximum tolerated dose ( MTD ) exceeded the lowest dose tested . \n Output:\n " }, { "from": "agent", "value": "Prophylactic CSFs significantly decrease the incidence of FN and the duration s of severe neutropenia , hospitalization , and antibiotic use in pediatric cancer patients , but they do not significantly decrease documented infections" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Sleep habits and circadian preference ( morningness/eveningness , M/E ) have been extensively analyzed in adolescents and young adults , while few studies were conducted on children and early adolescents . Aim of the present study was to investigate the developmental changes of circadian preference and to analyze its relationship with sleep habits , sleep problems and circadian preference in a large sample by means of a school-based survey . One thous and seventy-three participants ( 50.8 % boys and 49.2 % girls ; mean age = 10.6 ; range = 8 - 14 years ) , recruited from four schools r and omly extracted within the district of Rome , completed a modified version of School Sleep Habits Survey developed by Carskadon et al. The question naire included items about sleep habits during schooldays and weekends ; a Sleepiness Scale ; a Sleep-Wake Problems Behaviour Scale ; a Morningness/Eveningness scale . The results show a consistent age-related change in sleep habits , particularly in the weekends . The difference in sleep duration between schooldays and weekends increases linearly with age . No gender difference was observed in morningness/eveningness , while a significant linear increase in evening preference was found with increasing ages . M/E total scores correlated significantly with both self-reported sleep/wake problems and daytime sleepiness indicating a higher prevalence of sleep complaints in evening-type subjects . Overall , the present results support the existence of consistent age-related changes in sleep habits and M/E dimension in the 8- to 14-year age range Objective To examine whether behavioural strategies design ed to improve children ’s sleep problems could also improve the symptoms , behaviour , daily functioning , and working memory of children with attention deficit hyperactivity disorder ( ADHD ) and the mental health of their parents . Design R and omised controlled trial . Setting 21 general paediatric practice s in Victoria , Australia . Participants 244 children aged 5 - 12 years with ADHD attending the practice s between 2010 and 2012 . Intervention Sleep hygiene practice s and st and ardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call . Children in the control group received usual clinical care . Main outcome measures At three and six months after r and omisation : severity of ADHD symptoms ( parent and teacher ADHD rating scale IV— primary outcome ) , sleep problems ( parent reported severity , children ’s sleep habits question naire , actigraphy ) , behaviour ( strengths and difficulties question naire ) , quality of life ( pediatric quality of life inventory 4.0 ) , daily functioning ( daily parent rating of evening and morning behavior ) , working memory ( working memory test battery for children , six months only ) , and parent mental health ( depression anxiety stress scales ) . Results Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months ( adjusted mean difference for change in symptom severity −2.9 , 95 % confidence interval −5.5 to −0.3 , P=0.03 , effect size −0.3 , and −3.7 , −6.1 to −1.2 , P=0.004 , effect size −0.4 , respectively ) . Compared with control children , intervention children had fewer moderate-severe sleep problems at three months ( 56 % v 30 % ; adjusted odds ratio 0.30 , 95 % confidence interval 0.16 to 0.59 ; P<0.001 ) and six months ( 46 % v 34 % ; 0.58 , 0.32 to 1.0 ; P=0.07 ) . At three months this equated to a reduction in absolute risk of 25.7 % ( 95 % confidence interval 14.1 % to 37.3 % ) and an estimated number needed to treat of 3.9 . At six months the number needed to treat was 7.8 . Approximately a half to one third of the beneficial effect of the intervention on ADHD symptoms was mediated through improved sleep , at three and six months , respectively . Intervention families reported greater improvements in all other child and family outcomes except parental mental health . Teachers reported improved behaviour of the children at three and six months . Working memory ( backwards digit recall ) was higher in the intervention children compared with control children at six months . Daily sleep duration measured by actigraphy tended to be higher in the intervention children at three months ( mean difference 10.9 minutes , 95 % confidence interval −19.0 to 40.8 minutes , effect size 0.2 ) and six months ( 9.9 minutes , −16.3 to 36.1 minutes , effect size 0.3 ) ; however , this measure was only completed by a subset of children ( n=54 at three months and n=37 at six months ) . Conclusions A brief behavioural sleep intervention modestly improves the severity of ADHD symptoms in a community sample of children with ADHD , most of whom were taking stimulant medications . The intervention also improved the children ’s sleep , behaviour , quality of life , and functioning , with most benefits sustained to six months post-intervention . The intervention may be suitable for use in primary and secondary care . Trial registration Current Controlled Trials IS RCT N68819261 OBJECTIVE . Our goal was to identify characteristics associated with inadequate sleep for a national r and om sample of elementary school – aged children ( 6–11 years ) and adolescents ( 12–17 years ) . METHODS . Data from 68418 participants in the 2003 National Survey of Children 's Health were analyzed by using weighted bivariate and multivariate regression models . The dependent variable was report of not getting enough sleep for a child of his or her age ≥1 night of the past week . Independent variables included demographic characteristics , child health , school and other activities , and family life . RESULTS . Parents of elementary school – aged children with inadequate sleep were more likely to report that their child was having problems at school or had a father with fair or poor health . Parents of adolescents with inadequate sleep were more likely to report that their child had an atopic condition , frequent or severe headaches , a parent with less-than-excellent emotional health , or experienced frequent parental anger . Inadequate sleep in both age groups was associated with parental report that their child usually or always displayed depressive symptomatology , family disagreements involved heated arguing , or parental concern that the child was not always safe at home , at school , or in their neighborhood . CONCLUSIONS . Approximately 15 million American children are affected by inadequate sleep . Primary care providers should routinely identify and address inadequate sleep and its associated health , school , and family factors OBJECTIVES This study examined the hypothesis that domains of neurobehavioral function would be selectively affected by sleep-disordered breathing ( SDB ) . Therefore , we assessed potential relationships between objective ly measured sleep disturbances and neurobehavioral function in children with reported symptoms of attention-deficit/hyperactivity disorder ( ADHD ) and also determined the incidence of snoring and other sleep problems in 5- to 7-year-old children in the local community and potential relationships to parental snoring and passive smoking . METHODS Parents of 5- to 7-year-old children in public schools were surveyed about their child 's sleeping habits using a vali date d question naire . The question naire also asked whether they believed their child to be hyperactive or have ADHD . Children with reported symptoms of ADHD and control children were r and omly selected and invited to the Sleep Medicine Center for an overnight polysomnographic assessment and a battery of neurocognitive tests . RESULTS The question naire response rate was 47.6 % ( n = 5728 ) . Frequent and loud snoring was reported for 673 children ( 11.7 % ) . Similarly , 418 ( 7.3 % ) children were reported to have hyperactivity/ADHD , 313 ( 76.5 % ) of which were boys . Eighty-three children with parentally reported symptoms of ADHD were invited for full evaluation at the Sleep Medicine Center together with 34 control children . After assessment with the Conners ' Parent Rating Scale , 44 children were design ated as having \" significant \" symptoms of ADHD , 27 as \" mild , \" and 39 design ated as \" none \" ( controls ) . Overnight polysomnography indicated that obstructive sleep apnea was present in 5 % of those with significant ADHD symptoms , 26 % of those with mild symptoms , and 5 % of those with no symptoms . In the cohort , no sleep variable accounted for more than a negligible proportion of the variance in domains of neurobehavioral function . CONCLUSIONS An unusually high prevalence of snoring was identified among a group of children design ated as showing mild symptoms of ADHD based on the Conners ' ADHD index identified from a community sample . However , whereas SDB is not more likely to occur among children with significant ADHD symptoms , it is significantly highly prevalent among children with mild hyperactive behaviors . Sleep studies further revealed that rapid eye movement disturbances are more likely to occur in children with significant symptoms , and they seem to impose significant but mild effects on daytime neurobehavioral functioning . We conclude that in children with significant symptoms of ADHD , the prevalence of SDB is not different from that of the general pediatric population and that rapid eye movement sleep in these children is disturbed and may contribute to the severity of their behavioral manifestations . Furthermore , SDB can lead to mild ADHD-like behaviors that can be readily misperceived and potentially delay the diagnosis and appropriate treatment Children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) experience high rates of sleep problems and are also at increased risk for experiencing comorbid mental health problems . This study provides an initial examination of the 1-year prospect i ve association between sleep problems and comorbid symptoms in youth diagnosed with ADHD . Participants were 81 young adolescents ( 75 % male ) carefully diagnosed with ADHD and their parents . Parents completed measures of their child ’s sleep problems and ADHD symptoms , oppositional defiant disorder ( ODD ) symptoms , and general externalizing behavior problems at baseline ( Mage = 12.2 ) and externalizing behaviors were assessed again 1 year later . Adolescents completed measures of anxiety and depression at both time-points . Medication use was not associated with sleep problems or comorbid psychopathology symptoms . Regression analyses indicated that , above and beyond demographic characteristics , ADHD symptom severity , and initial levels of comorbidity , sleep problems significantly predicted greater ODD symptoms , general externalizing behavior problems , and depressive symptoms 1 year later . Sleep problems were not concurrently or prospect ively associated with anxiety . Although this study precludes making causal inferences , it does nonetheless provide initial evidence of sleep problems predicting later comorbid externalizing behaviors and depression symptoms in youth with ADHD . Additional research is needed with larger sample s and multiple time-points to further examine the interrelations of sleep problems and comorbidity This study evaluated the efficacy and safety of lisdexamfetamine dimesylate ( LDX ) compared with placebo in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) in Europe . Osmotic-release oral system methylpheni date ( OROS-MPH ) was included as a reference arm . Patients ( 6 - 17 years old ) with a baseline ADHD Rating Scale version IV ( ADHD-RS-IV ) total score ≥ 28 were r and omized ( 1:1:1 ) to dose-optimized LDX ( 30 , 50 , or 70 mg/day ) , OROS-MPH ( 18 , 36 , or 54 mg/day ) or placebo for 7 weeks . Primary and key secondary efficacy measures were the investigator-rated ADHD-RS-IV and the Clinical Global Impressions-Improvement ( CGI-I ) rating , respectively . Safety assessment s included treatment-emergent adverse events ( TEAEs ) , electrocardiograms , and vital signs . Of 336 patients r and omized , 196 completed the study . The difference between LDX and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -18.6 ( 95 % confidence interval [ CI ] : -21.5 to -15.7 ) ( p<0.001 ; effect size , 1.80 ) . The difference between OROS-MPH and placebo in least squares mean change in ADHD-RS-IV total score from baseline to endpoint was -13.0 ( 95 % CI : -15.9 to -10.2 ) ( p<0.001 ; effect size , 1.26 ) . The proportions ( 95 % CI ) of patients showing improvement ( CGI-I of 1 or 2 ) at endpoint were 78 % ( 70 - 86 ) , 14 % ( 8 - 21 ) , and 61 % ( 51 - 70 ) for LDX , placebo , and OROS-MPH . The most common TEAEs for LDX were decreased appetite , headache , and insomnia . Mean changes in vital signs were modest and consistent with the known profile of LDX . LDX was effective and generally well tolerated in children and adolescents with ADHD This prospect i ve longitudinal study evaluated the impact of daytime sleepiness on the school performance of 62 college students diagnosed comprehensively with attention deficit hyperactivity disorder . The primary goal of the study was to determine if self-reported daytime sleepiness rated at the beginning of the academic year could predict academic and overall functioning at the end of the academic year while also considering potentially important covariates , including symptoms of inattention , hyperactivity and impulsivity , medication status and whether or not students lived at home or on-campus . Self-reported daytime sleepiness predicted longitudinally school maladjustment , overall functional impairment and the number of D and F grade s ( i.e. poor and failing ) students received in courses above and beyond both self- and parent-report of symptoms , but \n Output:\n " }, { "from": "agent", "value": "Findings are mixed but overall suggest associations between sleep disturbances and 1 ) ADHD symptoms in the population and 2 ) poorer clinical , neurocognitive , and functional outcomes among adolescents with ADHD ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The role of folic acid ( 5mg/day ) in combination with oral hygiene measures ( group II ) vis-a-vis oral hygiene measures alone ( group I ) in prevention of phenytoin-induced gingival overgrowth was investigated in a one-year follow-up study on sixty , 8 - 13-year-old epileptic children receiving phenytoin . The allocation of the children to the two groups was done alternately . In these children , at baseline , plaque ( Silness & Löe ) , gingivitis ( Löe & Silness ) and probing depths of gingival sulcus were recorded . These parameters were re-evaluated at 3-monthly intervals when gingival overgrowth was also recorded ( Modified Harris & Ewalt Index ) . It was seen that , after a period of one year , gingival overgrowth occurred in 60 and 50 percent children of groups I & II respectively and its development , too , was delayed in group II . More cases ( 93 percent ) in group II exhibited minimal overgrowth as against 78 percent in group I. The study concluded that systemic folic acid prescribed along with phenytoin delays the onset and reduces the incidence and severity of gingival overgrowth induced by phenytoin Summary Fifty-four out- patients with epilepsy who had been taking phenytoin for more than one year were examined for gingival hyperplasia . Approximately 76 % of patients showed either mild or no gingival hyperplasia . Lesion severity was then compared statistically to phenytoin dosage and drug concentrations as well as to other clinical and laboratory parameters . There was a tendency for gingival hypertrophy to be associated with both increasing dosage of phenytoin per unit of body weight and the duration of phenytoin administration . All patients followed had a statistically significant progressive trend to increasing gingival hyperplasia with higher total and free phenytoin concentration BACKGROUND More than 30 percent of patients with epilepsy have inadequate control of seizures with drug therapy , but why this happens and whether it can be predicted are unknown . We studied the response to antiepileptic drugs in patients with newly diagnosed epilepsy to identify factors associated with subsequent poor control of seizures . METHODS We prospect ively studied 525 patients ( age , 9 to 93 years ) who were given a diagnosis , treated , and followed up at a single center between 1984 and 1997 . Epilepsy was classified as idiopathic ( with a presumed genetic basis ) , symptomatic ( result ing from a structural abnormality ) , or cryptogenic ( result ing from an unknown underlying cause ) . Patients were considered to be seizure-free if they had not had any seizures for at least one year . RESULTS Among the 525 patients , 333 ( 63 percent ) remained seizure-free during antiepileptic-drug treatment or after treatment was stopped . The prevalence of persistent seizures was higher in patients with symptomatic or cryptogenic epilepsy than in those with idiopathic epilepsy ( 40 percent vs. 26 percent , P=0.004 ) and in patients who had had more than 20 seizures before starting treatment than in those who had had fewer ( 51 percent vs. 29 percent , P<0.001 ) . The seizure-free rate was similar in patients who were treated with a single established drug ( 67 percent ) and patients who were treated with a single new drug ( 69 percent ) . Among 470 previously untreated patients , 222 ( 47 percent ) became seizure-free during treatment with their first antiepileptic drug and 67 ( 14 percent ) became seizure-free during treatment with a second or third drug . In 12 patients ( 3 percent ) epilepsy was controlled by treatment with two drugs . Among patients who had no response to the first drug , the percentage who subsequently became seizure-free was smaller ( 11 percent ) when treatment failure was due to lack of efficacy than when it was due to intolerable side effects ( 41 percent ) or an idiosyncratic reaction ( 55 percent ) . CONCLUSIONS Patients who have many seizures before therapy or who have an inadequate response to initial treatment with antiepileptic drugs are likely to have refractory epilepsy \n Output:\n " }, { "from": "agent", "value": "Although several studies examined the effects of PHT on oral health , none have studied those of the newer generation of AEDs ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Malignant pleural mesothelioma is a mainly asbestos-related neoplasm that occurs with increasing frequency and is associated with a poor prognosis . Extrapleural pneumonectomy which was initially performed as a st and -alone treatment in patients with resectable disease is now currently almost uniformly applied as part of a multi-modal approach . Its value and advantage over other therapeutic strategies remain points of discussion . We therefore analysed our experience with extrapleural pneumonectomy in the treatment of malignant pleural mesothelioma . METHODS We retrospectively review ed our institutional experience with all consecutive patients undergoing extrapleural pneumonectomy for malignant pleural mesothelioma from 1994 to 2005 . Patients were analysed with regard to hospital mortality and morbidity and long-term outcome . RESULTS Forty-nine patients ( 10 female/39 male , mean age 58 + 12 years ) underwent extrapleural pneumonectomy during the observation period . Median ICU stay was 1 day , median postoperative length of hospital stay was 13 days . After a mean follow-up of 2573 days , median survival was 376 days ( mean 672 + 121 days , range 9 - 3384 ) . One-year survival was 53 % , 3-year survival 27 % and 5-year survival 19 % . CONCLUSION Extrapleural pneumonectomy as part of a multi-modality treatment regimen is a good treatment option for selected patients with malignant pleural mesothelioma . The long-term results of this limited series compare favourably to non-surgical treatment regimens . Larger r and omised prospect i ve multi-centre trials are warranted to establish clear guidelines BACKGROUND Trimodality therapy seems to be the best treatment for malignant pleural mesothelioma ( MPM ) . A large experience served to evaluate the efficacy of surgery followed by adjuvant chemo-radiotherapy . Trimodality therapy results have led us to test induction chemotherapy followed by EPP and adjuvant radiotherapy in stages I-III of MPM . The aim of our study was to evaluate the feasibility of this protocol and to estimate survival . METHODS From 2000 to 2003 , 21 patients with MPM ( 14 males and 7 females , median age 59 years ) were enrolled in the prospect i ve study . Induction chemotherapy consisted of Carboplatin ( AUC 5mg/mL/min on Day 1 ) and Gemcitabine ( 1000mg/m(2 ) on Days 1 , 8 , 15 ) for three to four cycles . EPP was performed 3 - 5 weeks after induction therapy , while post-operative RT was given 4 - 6 weeks after operation . RESULTS Ten patients received three cycles of chemotherapy , 10 patients received four cycles and 1 patient had two cycles . Grade s 3 - 4 haematological toxicity occurred in eight ( 38.1 % ) patients . Chemotherapy response rate was : complete 0 % , partial 33.3 % and stable disease 66.7 % . Seventeen ( 80.9 % ) out of 21 patients underwent EPP with no intra or post-operative mortality with an overall major and minor morbidity rate at 52.4 % . Median survival was 25.5 months , with an overall 1 , 3 and 5-year survival rate of 71 , 33 and 19 % , respectively . CONCLUSIONS In MPM , the combined modality approach using the Carboplatin/Gemcitabine combination as induction chemotherapy is feasible , with good results in terms of survival and morbidity . Our results are similar to those of other studies using a heavier modality treatment Aprotinin has been used to decrease blood loss with complicated cardiac surgery but has not been investigated in extrapleural pneumonectomy , an operation that does not use cardiopulmonary bypass . In this prospect i ve , r and omized , placebo‐controlled , double‐blind trial , the authors investigated whether aprotinin decreased blood loss in patients who underwent this operation Abstract Background : We analyzed morbidity and mortality , sites of recurrence , and possible prognostic factors in 95 ( 78 male , 17 female ) patients with MPM on phase I – III trials since 1990 . A debulking resection to a requisite , residual tumor thickness of ≤ 5 mm was required for inclusion . Methods : Preoperative tumor volumes were determined by three-dimensional reconstruction of chest computerized tomograms . Pleurectomy ( n=39 ) or extrapleural pneumonectomy ( EPP ; n=39 ) was performed . Seventeen patients could not be debulked . Preoperative EPP platelet counts ( 404,000 ) and mean tumor volume ( 491 cm3 ) were greater than that seen for pleurectomy ( 344,000 , 114 cm3 ) . Results : Median survival for all patients was 11.2 months , with that for pleurectomy 14.5 months , that for EPP 9.4 months , and that for unresectable patients 5.0 months . Arrhythmia ( n=14 ; 15 % ) was the most common complication , and there were two deaths related to surgery ( 2.0 % ) . Tumor volume of > 100 ml , biphasic histology , male sex , and elevated platelet count were associated with decreased survival ( p<0.05 ) . Both EPP and pleurectomy had equivalent recurrence rates ( 27 of 39 [ 69 % ] and 31 of 39 [ 79 % ] , respectively ) ; however , 17 of 27 EPP recurrences as opposed to 28 of 31 pleurectomy recurrences were locoregional ( p2=0.013 ) . Conclusions : Debulking resections for MPM can be performed with low operative mortality . Size and platelet count are important preoperative prognostic parameters for MPM . Patients with poor prognostic indicators should probably enter nonsurgical , innovative trials where toxicity or response to therapy can be evaluated BACKGROUND The factors influencing outcome after resection of malignant pleural mesothelioma ( MPM ) are controversial . This analysis of a prospect i ve surgical data base identifies important prognostic factors . METHODS Tumors were staged by the International Mesothelioma Interest Group staging system , and patients were followed until death . Prognostic factors were analyzed by log rank and Cox regression , and were considered significant if p was less than 0.05 . RESULTS From Oct 1983 to May 1998 , 231 patients underwent thoracotomy , 115 had extrapleural pneumonectomy ( EPP ) , and 59 pleurectomy/decortication ( P/D ) . Among patients having EPP or P/D , 142 received adjuvant therapy . The median survival for stage I tumors was 29.9 months , for stage II 19 months , for stage III 10.4 months , and for stage IV 8 months . By multivariate analysis , stage , histology , gender , adjuvant therapy , but not the type of surgical resection , were significant . CONCLUSIONS The better survival previously reported for P/D compared with EPP is not seen in a large data base with long follow-up . Stages I and II have better survival rates than generally assumed for MPM . Locally advanced T and N status , and nonepithelial histology , identify poor prognosis patients who should be considered for novel treatment regimens OBJECTIVE The authors examine the feasibility and efficacy of trimodality therapy in the treatment of malignant pleural mesothelioma and identify prognostic factors . BACKGROUND Mesothelioma is a rare , uniformly fatal disease that has increased in incidence in recent decades . Single and bimodality therapies do not improve survival . METHODS From 1980 to 1995 , 120 patients underwent treatment for pathologically confirmed malignant mesothelioma at Brigham and Women 's Hospital and Dana-Farber Cancer Institute ( Boston , MA ) . Initial patient evaluation was performed by a multimodality team . Patients meeting selection criteria and with resectable disease identified by computed tomography scan or magnetic resonance imaging underwent extrapleural pneumonectomy followed by combination chemotherapy and radiotherapy . RESULTS The cohort included 27 women and 93 men with a mean age of 56 years . Operative mortality rate was 5.0 % , with a major morbidity rate of 22 % . Overall survival rates were 45 % at 2 years and 22 % at 5 years . Two and 5-year survival rates were 65 % and 27 % , respectively , for patients with epithelial cell type , and 20 % and 0 % , respectively , for patients with sarcomatous or mixed histology tumors . Nodal involvement was a significant negative prognostic factor . Patients who were node negative with epithelial histology had 2- and 5-year survival rates of 74 % and 39 % , respectively . Involvement of margins at time of resection did not affect survival , except in the case of full-thickness , transdiaphragmatic invasion . Classification on the basis of a revised staging system stratified median survivals , which were 22 , 17 , and 11 months for stages I , II , and III , respectively ( p = 0.04 ) . CONCLUSIONS Extrapleural pneumonectomy with adjuvant therapy is appropriate treatment for selected patients with malignant mesothelioma selected using a revised staging system PURPOSE Patients with malignant pleural mesothelioma , a rapidly progressing malignancy with a median survival time of 6 to 9 months , have previously responded poorly to chemotherapy . We conducted a phase III trial to determine whether treatment with pemetrexed and cisplatin results in survival time superior to that achieved with cisplatin alone . PATIENTS AND METHODS Chemotherapy-naive patients who were not eligible for curative surgery were r and omly assigned to receive pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 on day 1 , or cisplatin 75 mg/m2 on day 1 . Both regimens were given intravenously every 21 days . RESULTS A total of 456 patients were assigned : 226 received pemetrexed and cisplatin , 222 received cisplatin alone , and eight never received therapy . Median survival time in the pemetrexed/cisplatin arm was 12.1 months versus 9.3 months in the control arm ( P = .020 , two-sided log-rank test ) . The hazard ratio for death of patients in the pemetrexed/cisplatin arm versus those in the control arm was 0.77 . Median time to progression was significantly longer in the pemetrexed/cisplatin arm : 5.7 months versus 3.9 months ( P = .001 ) . Response rates were 41.3 % in the pemetrexed/cisplatin arm versus 16.7 % in the control arm ( P < .0001 ) . After 117 patients had enrolled , folic acid and vitamin B12 were added to reduce toxicity , result ing in a significant reduction in toxicities in the pemetrexed/cisplatin arm . CONCLUSION Treatment with pemetrexed plus cisplatin and vitamin supplementation result ed in superior survival time , time to progression , and response rates compared with treatment with cisplatin alone in patients with malignant pleural mesothelioma . Addition of folic acid and vitamin B12 significantly reduced toxicity without adversely affecting survival time BACKGROUND The aim of this multicenter trial was to prospect ively evaluate neo-adjuvant chemotherapy followed by extrapleural pneumonectomy ( EPP ) and radiotherapy , including quality of life as outcome . PATIENTS AND METHODS Eligible patients had malignant pleural mesothelioma of all histological types , World Health Organization performance status of zero to two and clinical stage T1-T3 , N0 - 2 , M0 disease considered completely resectable . Neo-adjuvant chemotherapy consisted of three cycles of cisplatin and gemcitabine followed by EPP . Postoperative radiotherapy was considered for all patients . RESULTS In all , 58 of 61 patients completed three cycles of neo-adjuvant chemotherapy . Forty-five patients ( 74 % ) underwent EPP and in 37 patients ( 61 % ) the resection was complete . Postoperative radiotherapy was initiated in 36 patients . The median survival of all patients was 19.8 months [ 95 % confidence interval ( CI ) 14.6 - 24.5 ] . For the 45 patients undergoing EPP , the median survival was 23 months ( 95 % CI 16.6 - 32.9 ) . Psychological distress showed minor variations over time with distress above the cut-off score indicating no morbidity with 82 % ( N = 36 ) at baseline and 76 % ( N = 26 ) at 3 months after surgery ( P = 0.5 ) . CONCLUSIONS The observed rate of operability is promising . A median survival of 23 months for patients undergoing EPP compares favourably with the survival reported from single center studies of upfront surgery . This approach was not associated with an increase in psychological distress OBJECTIVE To report on the experience with radical surgery , with emphasis on the long-term outcome , for malignant pleural mesothelioma ( MPM ) at a single institution . METHODS From our prospect i ve data base over a \n Output:\n " }, { "from": "agent", "value": "DISCUSSION S The current evidence suggests that selected patients with malignant pleural mesothelioma may benefit from EPP , especially when combined with neoadjuvant or adjuvant chemotherapy and adjuvant radiotherapy" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Hepatitis C virus ( HCV ) infection , especially genotypes 1 and 4 , is associated with wide metabolic disarrangements . AIM To assess whether host metabolic factors influence sustained virological response ( SVR ) in patients with chronic hepatitis C genotype 4 ( HCV-4 ) treated with peginterferon / ribavirin and to evaluate the impact of antiviral therapy on insulin resistance ( IR ) and serum levels of adipocytokines . METHODS Changes in levels of adiponectin , leptin , TNF-α and the homeostasis model assessment for insulin resistance ( HOMA-IR ) on antiviral combination in patients with HCV-4 were analyzed and effect on response was studied . RESULTS 107 patients were included ( M/F 86/21 ; mean age 41.4±5.6 years ) . Neither serum adipocytokines nor HOMA-IR was correlated with viral load . SVR was achieved by 57 % of patients and was associated with fibrosis score ( odds ratio : 6.5 ; P = 0.001 ) and adiponectin level ( odds ratio : 1.3 ; P = 0.01 ) . At the end of follow-up , HOMA-IR , adiponectin , leptin and TNF-α were reduced , all these changes unrelated to predicting the outcome of treatment . At follow-up , HOMA-IR and adiponectin continued to decrease in patients with SVR , but remained unchanged significantly in patients who did not response or relapse . CONCLUSIONS Serum adiponectin at baseline appears to be an independent predictor for the achievement of SVR and can be utilized as an additional predictive marker . Changes of IR and adipocytokines occur under treatment which is more evident with the resolution of HCV infection , suggesting that HCV could have a direct role in these metabolic changes ABSTRACT Background : The evolution of the relationship between adiponectin and insulin sensitivity in hepatitis C virus ( HCV ) patients during viral clearance is unclear and warrants investigation . Methods : A prospect i ve study including 747 consecutive chronic hepatitis C ( CHC ) patients , of whom 546 had completed a course of anti-HCV therapy and underwent pre- , peri- and post-therapy surveys for anthropomorphic , viral , metabolic and hepatic profiles and adiponectin levels , was conducted in a tertiary care center . Results : Multivariate analyses indicated associations of sex , triglyceride levels and hepatic steatosis with adiponectin levels and of triglyceride levels and interferon λ3 ( IFNL3 ) genotype with homeostasis model assessment -estimated insulin resistance ( HOMA-IR ) levels before anti-HCV therapy . In patients with a sustained virological response ( SVR ; n = 455 ) , at 24 weeks post-therapy , sex , BMI , aspartate aminotransferase to platelet ratio index ( APRI ) , HOMA-IR and steatosis were associated with adiponectin levels , and IFNL3 genotype was associated with HOMA-IR levels . GEE analysis demonstrated that SVR affected longitudinal trends in adiponectin levels . Compared with pre-therapy levels , adiponectin and APRI levels decreased 24 weeks post-therapy in SVR patients , regardless of baseline insulin resistance ( IR ) . However , HOMA-IR levels decreased in SVR patients with baseline IR but increased in those without baseline IR . Compared with controls , immunohistochemical studies showed that pre-therapy CHC patients had higher hepatic adiponectin expression associated with hepatic fibrosis . Conclusions : During HCV infection , adiponectin may affect insulin sensitivity through triglycerides . After viral clearance , adiponectin levels were directly associated with insulin sensitivity and decreased upon improved hepatic fibrosis ; with a link to the IFNL3 genotype , insulin sensitivity improved only in patients with baseline IR Many studies showed insulin resistance amelioration in HCV- patients achieving Sustained Virologic Response ( SVR ) but results on glycemic control in diabetic patients are unclear . This study aim ed to assess fasting glucose ( FG ) and glycated hemoglobin ( HbA1c ) values before and after therapy with direct-acting antivirals ( DAAs ) in HCV- patients with type 2 diabetes mellitus ( T2DM ) . Of the 122 consecutively recruited patients with chronic hepatitis C and T2DM , 110 patients were treated with DAAs and 12 remained untreated . Clinical , biochemical , virological , and metabolic features were collected both at baseline and at 12 weeks after the end of therapy ( EOT ) or after a comparable period of time in untreated patients . A total of 101 patients obtained a SVR ( Group 1 ) , while nine were relapsers . Group 2 ( 21 patients ) was composed by the nine relapsers and the 12 untreated patients . A significant reduction of mean FG ( 134.3 ± 41.32 mg/dL vs 152.4 ± 56.40 mg/dL , P = 0.002 ) and HbA1c values ( 46.51 ± 16.15 mmoL/moL vs 52.15 ± 15.43 mmoL/moL , P < 0.001 ) was found in Group 1 but not in Group 2 ( 140.6 ± 47.87 mg/dL vs. 145.31 ± 30.18 mg/dL , P = 0.707 , and 55.31 ± 20.58 mmoL/moL vs. 53.38 ± 9.49 mmoL/moL , P = 0.780 ) . In Group 1 , 20.7 % of patients could reduce or suspend their antidiabetic therapy compared to none in Group 2 ( P = 0.03 ) , despite the significant weight increase observed in Group 1 . SVR induced a significant amelioration of glycemic control in diabetic HCV- patients , despite a significant weight increase ; larger prospect i ve studies are needed to verify whether these results are maintained over the long-term Objectives Genotype-specific associations between hepatitis C virus ( HCV ) and insulin resistance ( IR ) have been described , but a causal relationship remains unclear . This study investigated the association between a sustained virological response ( SVR ) and IR after chronic HCV therapy . Methods 2255 treatment-naive patients with chronic HCV genotype 1 or 2/3 were enrolled in two phase 3 trials of albinterferon alpha-2b versus pegylated interferon alpha-2a for 48 or 24 weeks , respectively . IR was measured before treatment and 12 weeks after treatment using homeostasis model assessment (HOMA)-IR . Results Paired HOMA-IR measurements were available in 1038 non-diabetic patients ( 497 with genotype 1 ; 541 with genotype 2/3 ) . At baseline the prevalence of HOMA-IR > 3 was greater in patients with genotype 1 than 2/3 ( 33 % vs 27 % ; p=0.048 ) . There was a significant reduction in the prevalence of IR in patients with genotype 1 achieving SVR ( δ 10 % ; p<0.001 ) , but not in genotype 1 non-responders or those with genotype 2/3 . Multivariate analysis indicated that SVR was associated with a significant reduction in mean HOMA-IR in patients with genotype 1 ( p=0.004 ) , but not in those with genotype 2/3 , which was independent of body mass index , alanine transaminase , γ-glutamyl transpeptidase and lipid level changes . Conclusions SVR is associated with a reduction in HOMA-IR in patients with HCV genotype 1 but not in those with genotype 2/3 . Genotype 1 may have a direct effect on the development of IR , independent of host metabolic factors , and may be partially reversed by viral eradication BACKGROUND & AIMS Our study was design ed to test the association between insulin resistance ( IR ) and hepatitis C virus ( HCV ) genotypes , serum HCV RNA level and liver fibrosis stage in a large prospect i ve cohort of chronic hepatitis C ( CHC ) patients . METHODS Six hundred consecutive patients ( CHC , n = 500 ; chronic hepatitis B ( CHB ) , n = 100 ) were evaluated on the day of liver biopsy . IR ( Homeostasis Model for Assessment of Insulin Resistance ) and all components of the metabolic syndrome were assessed . By logistic regression , independent factors associated with IR and those associated with significant fibrosis were assessed in nondiabetic and noncirrhotic CHC , respectively . Parameters of IR were compared between hepatitis B and 240 CHC matched by epidemiologic , metabolic , and histologic features . RESULTS IR was present in 32.4 % of the 462 nondiabetic CHC and associated with the metabolic syndrome , genotypes 1 and 4 , significant fibrosis , and severe steatosis . IR was diagnosed in 15 % of 145 CHC without metabolic syndrome or significant fibrosis , and associated with genotypes 1 and 4 , high serum HCV RNA level , and moderate-severe necroinflammation . Significant fibrosis was present in 51.1 % of the 454 noncirrhotic CHC patients and associated with male sex , age > 40 years , IR , moderate-severe necroinflammation , and severe steatosis . IR was less frequent in CHB than in matched CHC ( 5 % vs 35 % , respectively , P < .001 ) . CONCLUSIONS IR is a specific feature of CHC , associated with genotypes 1 and 4 and high serum HCV RNA level . Significant fibrosis is associated with IR independent from steatosis UNLABELLED Treatment response remains suboptimal for many patients with chronic hepatitis C , particularly those with genotype 1 and high levels of viremia . The efficacy of high-dose regimens of peginterferon alfa-2a and ribavirin was compared with conventional dose regimens in patients with features predicting poor treatment responses . Eligible treatment-naïve adults with genotype 1 infection , hepatitis C virus ( HCV ) RNA > 800,000 IU/mL and body weight > 85 kg were r and omized to double-blind treatment with peginterferon alfa-2a at 180 or 270 microg/week plus ribavirin at 1200 or 1600 mg/day for 48 weeks ( four regimens were evaluated ) . The primary endpoint was viral kinetics during the first 24 weeks of therapy . Among patients receiving peginterferon alfa-2a ( 270 microg/week ) the magnitude of HCV RNA reduction was significantly greater than for patients r and omized to the conventional dose of peginterferon alfa-2a ( 180 microg/week ) for the pairwise comparison for ribavirin at 1600 mg/day ( P = 0.036 ) and numerically greater for the pairwise comparison for ribavirin at 1200 mg/day ( P = 0.060 ) . Patients r and omized to the highest doses of peginterferon alfa-2a ( 270 microg/week ) and ribavirin ( 1600 mg/day ) experienced the numerically highest rates of sustained virologic response ( HCV RNA < 50 IU/mL ) and the lowest relapse rate ( 47 % and 19 % , respectively ) . The arm with the higher doses of both drugs was less well-tolerated than the other regimens . CONCLUSION Higher fixed doses of peginterferon alfa-2a ( 270 microg/week ) and ribavirin ( 1600 mg/day ) may increase sustained virologic response rates compared with lower doses of both drugs in patients with a cluster of difficult-to-treat characteristics BACKGROUND Insulin resistance ( IR ) is a key factor in the development of hepatic steatosis and fibrosis in chronic hepatitis C virus infection . Little is known about the impact of viral clearance on IR . AIM The aim of this study was to determine the impact of viral clearance on IR . METHODS Eighty-six patients treated according to st and ard clinical practice at an Australian teaching hospital between 2003 and 2007 were prospect ively studied . Demographic , biochemical and histological data were collected . RESULTS The mean pretreatment homeostatic model assessment -IR ( HOMA-IR ) was similar in the sustained virological response ( SVR ) and non-SVR groups ( 2.7 ± 0.5 and 2.8 ± 0.4 , respectively ) , and both values were consistent with significant IR . There was a significant improvement in HOMA-IR ( from 3.0 ± 1.0 to 2.2 ± 0.5 , P = 0.04 ) at the end of treatment in the SVR group only . This trended towards significance at 6 months post-treatment . Multiple regression analysis found improvement in both gamma-glutamyl transpeptidase and alanine aminotransferase predicted improvement in HOMA-IR when controlled for other potential factors ( P = 0.01 ) . CONCLUSIONS Hepatitis C virus clearance is associated with improvement in IR . Although baseline hepatic \n Output:\n " }, { "from": "agent", "value": "In conclusion , HCV patients who achieved SVR after IFN-based therapy exhibited improvement in HOMA-IR and HOMA-β .\nThe present results suggest that clinical management of IR and serum glucose levels may be an important way to impact the therapeutic response in HCV patients" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study was design ed to evaluate the effects of enriching an essential amino acid ( EAA ) mixture with leucine on muscle protein metabolism in elderly and young individuals . Four ( 2 elderly and 2 young ) groups were studied before and after ingestion of 6.7 g of EAAs . EAAs were based on the composition of whey protein [ 26 % leucine ( 26 % Leu ) ] or were enriched in leucine [ 41 % leucine ( 41 % Leu ) ] . A primed , continuous infusion of L-[ring-2H5]phenylalanine was used together with vastus lateralis muscle biopsies and leg arteriovenous blood sample s for the determinations of fractional synthetic rate ( FSR ) and balance of muscle protein . FSR increased following amino acid ingestion in both the 26 % ( basal : 0.048 + /- 0.005%/h ; post-EAA : 0.063 + /- 0.007%/h ) and the 41 % ( basal : 0.036 + /- 0.004%/h ; post-EAA : 0.051 + /- 0.007%/h ) Leu young groups ( P < 0.05 ) . In contrast , in the elderly , FSR did not increase following ingestion of 26 % Leu EAA ( basal : 0.044 + /- 0.003%/h ; post-EAA : 0.049 + /- 0.006%/h ; P > 0.05 ) but did increase following ingestion of 41 % Leu EAA ( basal : 0.038 + /- 0.007%/h ; post-EAA : 0.056 + /- 0.008%/h ; P < 0.05 ) . Similar to the FSR responses , the mean response of muscle phenylalanine net balance , a reflection of muscle protein balance , was improved ( P < 0.05 ) in all groups , with the exception of the 26 % Leu elderly group . We conclude that increasing the proportion of leucine in a mixture of EAA can reverse an attenuated response of muscle protein synthesis in elderly but does not result in further stimulation of muscle protein synthesis in young subjects Background Protein energy malnutrition ( PEM ) predisposes individuals to disease , delays recovery from illness and reduces quality of life . Care home residents in the United Kingdom are especially vulnerable , with an estimated 30 to 42 % at risk . Evidence for nutritional interventions to address PEM in the care home setting is lacking . Widely used techniques include food-based intervention and /or the use of prescribed oral nutritional supplements . To define outcomes and optimise the design for an adequately powered definitive trial to compare the efficacy of established nutritional interventions in this setting , a cluster r and omised feasibility trial with a 6-month intervention was undertaken . Methods Care home residents with or at risk of malnutrition were identified across six UK care home sites from September to December 2013 . Homes were cluster r and omised to st and ard care ( SC ) , food-based intervention ( FB ) or oral nutritional supplement intervention ( ONS ) , for 6 months . Key outcomes were trial feasibility and the acceptability of design , allocated interventions and outcome assessment s. Anthropometry , dietary intake , healthcare re source usage and participant-reported outcome measures were assessed at baseline and at 3 and 6 months . Results All six care homes approached were recruited and retained . Of the 110 residents at risk of malnutrition , 85 % entered the trial , and 68 % completed the 6-month intervention . Pre-specified success criteria for feasibility were met for recruitment and retention , intervention acceptability ( resident compliance ≥60 % ) and measurement of weight , body mass index ( BMI ) , mid-upper arm circumference and dietary intake ( data completeness > 80 % ) . Measurement of h and grip strength and triceps skinfold thickness was not found to be feasible in this population . The 95 % confidence interval ( CI ) data suggested sensitivity to change in dietary intake for weight , BMI and energy intake between baseline and 3 months when each intervention ( FB and ONS ) was compared with SC . Conclusions A definitive trial comparing the efficacy of nutritional support interventions in increasing weight and BMI in malnourished care home residents can be conducted . However , whilst the design was feasible , this trial has highlighted the lack of clinical ly and patient-relevant outcome measures that are appropriate for use in this setting for both research and clinical practice . In particular , this trial identified a need for a more simple measure of functional status , which considers the limitations of functional tests in the care home population .Trial registration Current Controlled Trials IS RCT N38047922 , Date assigned : 22 April 2014 The aims of this r and omised controlled trial were to determine if a high-intensity functional exercise program improves balance , gait ability , and lower-limb strength in older persons dependent in activities of daily living and if an intake of protein-enriched energy supplement immediately after the exercises increases the effects of the training . One hundred and ninety-one older persons dependent in activities of daily living , living in residential care facilities , and with a Mini-Mental State Examination ( MMSE ) score of ? 10 participated . They were r and omised to a high-intensity functional exercise program or a control activity , which included 29 sessions over 3 months , as well as to protein-enriched energy supplement or placebo . Berg Balance Scale , self-paced and maximum gait speed , and one-repetition maximum in lower-limb strength were followed-up at three and six months and analysed by 2 x 2 factorial ANCOVA , using the intention-to-treat principle . At three months , the exercise group had improved significantly in self-paced gait speed compared with the control group ( mean difference 0.04 m/s , p = 0.02 ) . At six months , there were significant improvements favouring the exercise group for Berg Balance Scale ( 1.9 points , p = 0.05 ) , self-paced gait speed ( 0.05 m/s , p = 0.009 ) , and lower-limb strength ( 10.8 kg , p = 0.03 ) . No interaction effects were seen between the exercise and nutrition interventions . In conclusion , a high-intensity functional exercise program has positive long-term effects in balance , gait ability , and lower-limb strength for older persons dependent in activities of daily living . An intake of protein-enriched energy supplement immediately after the exercises does not appear to increase the effects of the training OBJECTIVES Although oral nutritional supplements ( ONS ) are known to be effective to treat malnutrition in the elderly , evidence from nursing home population s , including individuals with dementia , is rare , especially with regard to functionality and well-being . A known barrier for ONS use among elderly is the volume that needs to be consumed , result ing in low compliance and thus reduced effectiveness . This study aim ed to investigate the effects of a low-volume , energy- and nutrient-dense ONS on nutritional status , functionality , and quality of life ( QoL ) of nursing home residents . DESIGN R and omized controlled intervention trial . SETTING Six nursing homes in Nürnberg and Fuerth , Germany . PARTICIPANTS Nursing home residents affected by malnutrition or at risk of malnutrition . INTERVENTION R and om assignment to intervention ( IG ) and control group ( CG ) , receiving 2 × 125 mL ONS ( 600 kcal , 24 g protein ) per day and routine care , respectively , for 12 weeks . MEASUREMENTS Nutritional ( weight , body mass index [ BMI ] , upper arm and calf circumferences , MNA-SF ) and functional parameters ( h and grip strength , gait speed , depressive mood [ GDS ] , cognition [ MMSE ] , activities of daily living [ Barthel ADL ] ) as well as QoL ( QUALIDEM ) were assessed at baseline ( T1 ) and after 12 weeks ( T2 ) . ONS intake was registered daily and compliance calculated . RESULTS A total of 77 residents ( 87 ± 6 y , 91 % female ) completed the study ; 78 % had dementia ( MMSE < 17 ) and 55 % were fully dependent ( ADL ≤30 ) . Median compliance was 73 % ( IQR 23.5%-86.5 % ) with median intake of 438 ( 141 - 519 ) kcal per day . Body weight , BMI , and arm and calf circumferences increased in the IG ( n = 42 ) and did not change in the CG ( n = 35 ) . Changes of all nutritional parameters except MNA-SF significantly differed between groups in favor of the IG ( P < .05 ) . GDS , h and grip strength , and gait speed could not be assessed in 46 % , 38 % , and 49 % of participants at T1 and /or T2 , because of immobility and cognitive impairment . In residents able to perform the test at both times , functionality remained stable in IG and CG , except for ADLs , deteriorating in both groups . From 10 QoL categories , \" positive self-perception \" increased in IG ( 78 [ 33 - 100 ] to 83 [ 56 - 100 ] ; P < .05 ) and tended to decrease in CG ( 100 [ 78 - 100 ] to 89 [ 56 - 100 ] ; P = .06 ) , \" being busy \" significantly dropped in CG ( 33 [ 0 - 50 ] to 0 [ 0 - 50 ] ; P < .05 ) . CONCLUSION Low-volume , nutrient- and energy-dense ONS were well accepted among elderly nursing home residents with high functional impairment and result ed in significant improvements of nutritional status and , thus , were effective to support treatment of malnutrition . Assessment of function was hampered by dementia and immobility , limiting the assessment of functionality , and highlighting the need for better tools for elderly with functional impairments . ONS may positively affect QoL but this requires further research Objectives To determine whether in the current study the supply of a nutrient dense drink has a positive effect on mental and physical function of institutionalized elderly people . Design A 24-week , r and omized , double-blind , placebo-controlled , parallel-group , intervention trial . Setting Homes for the elderly and nursing homes in the Netherl and s. Participants Institutionalized elderly people older than 60 years , with a BMI ≤ 30 kg/m2 , and a Mini-Mental State Examination score of at least 10 points . InterventionIn addition to their usual diet the participants ( n=176 ) received either a nutrient dense drink or a placebo drink twice a day during 24 weeks . Measurements The functionality measures included cognitive function , mood , physical performance and the ability to perform activities of daily living . Results In the supplement group a favorable effect of the intervention drink on body weight ( 1.6 kg difference in change ; P = .035 ) , calf circumference ( 0.9 cm difference in change ; P = .048 ) , and blood values ( e.g. Hcy decreased from 16.8 to 11.2 µmol/L in the supplement group ) was found . In the total group no significant effect was found on functionality outcomes . However , a subgroup of participants with BMI at baseline below 24.4 kg/m2 performed better on the cognitive subscale of Alzheimer ’s Disease Assessment Scale ( P = .09 ) , and its language sub score ( P = .01 ) after 24 weeks of intervention . Conclusion The results in the total group of this trial suggest that the nutritional supplement used in this study improves nutritional status . Furthermore , the results of this trial suggest that it is effective as treatment for decreasing function in a subgroup of institutionalized elderly people with low BMI The purpose was to test the hypothesis that a multifaceted 11 weeks r and omized controlled intervention would have a significant influence of functional abilities in old nursing home residents . Participants were 121 old ( > 65 years ) residents in seven Danish nursing homes . The intervention consisted of nutrition ( chocolate , homemade oral supplements ) , group exercise ( moderate intensity ) and oral care . Measurements taken were weight , body mass index ( BMI ) , energy and protein intake , and functional abilities ( activities of daily living = ADL , cognitive performance , and social engagement ) . The results showed that the nutrition and exercise were well accepted . After 11 weeks the change in % weight ( 1.3 vs. -0.6 % , p=0.005 ) , % BMI ( 0.4 vs. -0.2 % , p=0.003 ) , energy intake ( 0.7 vs. -0.3 MJ/day , p=0.084 ) and protein intake ( 5 vs. -2g/day , p=0.012 ) was higher in the intervention group than in the control group . Also , after 11 weeks , social and physical function had decreased in the control group but was unchanged in the intervention group . The difference between groups was significant in relation to social engagement ( p=0.009 ) . After the end of the intervention both groups had lost weight and physical function . Cognitive performance did not change , at any time . In conclusion , it seems possible to maintain social ( and physical ) functional abilities in old nursing home residents by means of a multifaceted intervention BACKGROUND Nutritional status is associated with physical functioning in older people . Protein-energy malnutrition can limit functional performance . OBJECTIVES This study examined the effectiveness of a \" need- \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Nutritional intervention with older people in residential facilities was effective in improving h and grip strength , but did not significantly improve scores for activities of daily living , balance , gait velocity or preventing death ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose Poor medication adherence in adolescents with asthma results in poorly controlled disease and increased morbidity . The aim of the ADolescent Adherence Patient Tool ( ADAPT ) study is to develop an mHealth intervention to support self-management and to evaluate the effectiveness in improving medication adherence and asthma control . Intervention The ADAPT intervention consists of an interactive smartphone application ( app ) connected to a desktop application for health care providers , in this study , the community pharmacist . The app contains several functions to improve adherence as follows : 1 ) a question naire function to rate asthma symptoms and monitor these over time ; 2 ) short movie clips with medication and disease information ; 3 ) a medication reminder ; 4 ) a chat function with peers ; and 5 ) a chat function with the pharmacist . The pharmacist receives data from the patient ’s app through the desktop application , which enables the pharmacist to send information and feedback to the patient . Study design The ADAPT intervention is tested in a community pharmacy-based cluster r and omized controlled trial in the Netherl and s , aim ing to include 352 adolescents with asthma . The main outcome is adherence , measured by patient ’s self-report and refill adherence calculated from pharmacy dispensing records . In addition , asthma control , illness perceptions , medication beliefs , and asthma-related quality of life are measured . Conclusion This study will provide in-depth knowledge on the effectiveness of an mHealth intervention to support asthma self-management in adolescents . These insights will also be useful for adolescents with other chronic diseases OBJECTIVE To test the efficacy of a weight loss mobile app based on recommender systems and developed by experts in health promotion and computer science to target social support and self-monitoring of diet , physical activity ( PA ) , and weight ( Social POD app ) , compared to a commercially available diet and PA tracking app ( st and ard ) . MATERIAL S AND METHODS Overweight adults [ N=51 ] were recruited and r and omly assigned to either the experimental group [ n=26 ; theory-based podcasts (TBP)+Social POD app ] or the comparison group ( n=25 ; TBP+st and ard app ) . The Social POD app issued notifications to encourage users to self-monitor and send theory-based messages to support users who had not self-monitored in the previous 48h . Independent sample s t-test were used to examine group differences in kilograms lost and change in BMI . Analysis of covariance was used to analyze secondary outcomes while controlling for baseline values . RESULTS Participant attrition was 12 % ( n=3 experimental and n=3 comparison ) . Experimental group participants lost significantly more weight ( -5.3 kg , CI : -7.5 , -3.0 ) than comparison group ( -2.23 kg , CI : -3.6 , -1.0 ; d=0.8 , r=0.4 , p=0.02 ) and had a greater reduction in BMI ( p=0.02 ) . While there were significant differences in positive outcome expectations between groups ( p=0.04 ) other secondary outcomes ( e.g. , caloric intake and social support ) were not significant . DISCUSSION Use of the Social POD app result ed in significantly greater weight loss than use of a commercially available tracking app . This mobile health intervention has the potential to be widely disseminated to reduce the risk of chronic disease associated with overweight and obesity Background Chronic diseases , including diabetes mellitus , are the leading cause of mortality and disability in the United States . Current solutions focus primarily on diagnosis and pharmacological treatment , yet there is increasing evidence that patient-centered models of care are more successful in improving and addressing chronic disease outcomes . Objective The objective of this clinical trial is to evaluate the impact of a mobile health ( mHealth ) enabled nurse health coaching intervention on self-efficacy among adults with type-2 diabetes mellitus . Methods A r and omized controlled trial was conducted at an academic health system in Northern California . A total of 300 participants with type-2 diabetes were scheduled to be enrolled through three primary care clinics . Participants were r and omized to either usual care or intervention . All participants received training on use of the health system patient portal . Participants in the intervention arm received six scheduled health-coaching telephone calls with a registered nurse and were provided with an activity tracker and mobile application that integrated data into the electronic health record ( EHR ) to track their daily activity and health behavior decisions . All participants completed a baseline survey and follow-up surveys at 3 and 9 months . Primary and secondary outcomes include diabetes self-efficacy , hemoglobin A1c ( HbA1c ) , and quality of life measures . Results Data collection for this trial , funded by the Patient-Centered Outcomes Research Institute , will be completed by December 2017 . Results from the trial will be available mid-2018 . Conclusions This protocol details a patient-centered intervention using nurse health coaching , mHealth technologies , and integration of patient-generated data into the EHR . The aim of the intervention is to enhance self-efficacy and health outcomes by providing participants with a mechanism to track daily activity by offering coaching support to set reasonable and attainable health goals , and by creating a complete feedback loop by bringing patient-generated data into the EHR . Trial Registration Clinical Trials.gov NCT02672176 ; https:// clinical trials.gov/ct2/show/NCT02672176 ( Archived by WebCite at http://www.webcitation.org/6xEQXe1M5 Background The use of web-based monitoring for lung cancer patients is growing in interest because of promising recent results suggesting improvement in cancer and re source utilization outcomes . It remains an open question whether the overall survival ( OS ) in these patients could be improved by using a web-mediated follow-up rather than classical scheduled follow-up and imaging . Methods Advanced-stage lung cancer patients without evidence of disease progression after or during initial treatment were r and omly assigned in a multicenter phase III trial to compare a web-mediated follow-up algorithm ( experimental arm ) , based on weekly self-scored patient symptoms , with routine follow-up with CT scans scheduled every three to six months according to the disease stage ( control arm ) . In the experimental arm , an alert email was automatically sent to the oncologist when self-scored symptoms matched predefined criteria . The primary outcome was OS . Results From June 2014 to January 2016 , 133 patients were enrolled and 121 were retained in the intent-to-treat analysis ; 12 deemed ineligible after r and om assignment were not subsequently followed . Most of the patients ( 95.1 % ) had stage III or IV disease . The median follow-up was nine months . The median OS was 19.0 months ( 95 % confidence interval [ CI ] = 12.5 to noncalculable ) in the experimental and 12.0 months ( 95 % CI = 8.6 to 16.4 ) in the control arm ( one-sided P = .001 ) ( hazard ratio = 0.32 , 95 % CI = 0.15 to 0.67 , one-sided P = .002 ) . The performance status at first detected relapse was 0 to 1 for 75.9 % of the patients in the experimental arm and for 32.5 % of those in the control arm ( two-sided P < .001 ) . Optimal treatment was initiated in 72.4 % of the patients in the experimental arm and in 32.5 % of those in the control arm ( two-sided P < .001 ) . Conclusions A web-mediated follow-up algorithm based on self-reported symptoms improved OS due to early relapse detection and better performance status at relapse Background Chronic kidney disease ( CKD ) is a growing global problem affecting around 10 % of many countries ’ population s. Providing appropriate palliative care services ( PCS ) to those with advanced kidney disease is becoming paramount . Palliative/supportive care alongside usual CKD clinical treatment is gaining acceptance in nephrology services although the collaboration with and use of PCS is not consistent . Methods The goal of this study was to track and quantify the health service utilisation of people with CKD stages 3 - 5 over the last 12 months of life . Patients were recruited from a kidney health service ( Queensl and , Australia ) for this prospect i ve , longitudinal study . Data were collected for 12 months ( or until death , whichever was sooner ) during 2015 - 17 from administrative health sources . Emergency department presentations ( EDP ) and inpatient admissions ( IPA ) ( collectively referred to as critical events ) were review ed by two Nephrologists to gauge if the events were avoidable . Results Participants ( n = 19 ) with a median age of 78 years ( range 42 - 90 ) , were mostly male ( 63 % ) , 79 % had CKD stage 5 , and were heavy users of health services during the study period . Fifteen patients ( 79 % ) collectively recorded 44 EDP ; 61 % occurred after-hours , 91 % were triaged as imminently and potentially life-threatening and 73 % were admitted . Seventy-four IPA were collectively recorded across 16 patients ( 84 % ) ; 14 % occurred on weekends or public holidays . Median length of stay was 3 days ( range 1 - 29 ) . The median number of EDP and IPA per patient was 1 and 2 ( range 0 - 12 and 0 - 20 ) respectively . The most common trigger to both EDP ( 30 % ) and IPA ( 15 % ) was respiratory distress . By study end 37 % of patients died , 63 % were known to PCS and 11 % rejected a referral to a PCS . All critical events were deemed unavoidable . Conclusions Few patients avoided using acute health care services in a 12 month period , highlighting the high service needs of this cohort throughout the long , slow decline of CKD . Proactive end-of-life care earlier in the disease trajectory through integrating renal and palliative care teams may avoid acute presentations to hospital through better symptom management and planned care pathways OBJECTIVES This study evaluated the effectiveness ( changes in health behaviors , health status , and health service utilization ) of a self-management program for chronic disease design ed for use with a heterogeneous group of chronic disease patients . It also explored the differential effectiveness of the intervention for subjects with specific diseases and comorbidities . METHODS The study was a six-month r and omized , controlled trial at community-based sites comparing treatment subjects with wait-list control subjects . Participants were 952 patients 40 years of age or older with a physician-confirmed diagnosis of heart disease , lung disease , stroke , or arthritis . Health behaviors , health status , and health service utilization , as determined by mailed , self-administered question naires , were measured . RESULTS Treatment subjects , when compared with control subjects , demonstrated improvements at 6 months in weekly minutes of exercise , frequency of cognitive symptom management , communication with physicians , self-reported health , health distress , fatigue , disability , and social/role activities limitations . They also had fewer hospitalizations and days in the hospital . No differences were found in pain/physical discomfort , shortness of breath , or psychological well-being . CONCLUSIONS An intervention design ed specifically to meet the needs of a heterogeneous group of chronic disease patients , including those with comorbid conditions , was feasible and beneficial beyond usual care in terms of improved health behaviors and health status . It also result ed in fewer hospitalizations and days of hospitalization BACKGROUND Diabetes is a chronic disease , with high prevalence across many nations , which is characterized by elevated level of blood glucose and risk of acute and chronic complication . The Kingdom of Saudi Arabia ( KSA ) has one of the highest levels of diabetes prevalence globally . It is well-known that the treatment of diabetes is complex process and requires both lifestyle change and clear pharmacologic treatment plan . To avoid the complication from diabetes , the effective behavioural change and extensive education and self-management is one of the key approaches to alleviate such complications . However , this process is lengthy and expensive . The recent studies on the user of smart phone technologies for diabetes self-management have proven to be an effective tool in controlling hemoglobin ( HbA1c ) levels especially in type-2 diabetic ( T2D ) patients . However , to date no reported study addressed the effectiveness of this approach in the in Saudi patients . This study investigates the impact of using mobile health technologies for the self-management of diabetes in Saudi Arabia . METHODS In this study , an intelligent mobile diabetes management system ( SAED ) , tailored for T2D patients in KSA was developed . A pilot study of the SAED system was conducted in Saudi Arabia with 20 diabetic patients for 6 months duration . The patients were r and omly categorized into a control group who did not use the SAED system and an intervention group whom used the SAED system for their diabetes management during this period . At the end of the follow-up period , the HbA1c levels in the patients in both groups were measure together with a diabetes knowledge test was also conducted to test the diabetes awareness of the patients . RESULTS The results of SAED pilot study showed that the patients in the intervention group were able to significantly decrease their HbA1c levels compared to the control group . The SAED system also enhanced the diabetes awareness amongst the patients in the intervention group during the trial period . These outcomes confirm the global studies on the effectiveness of smart phone technologies in diabetes management . The significance of the study is that this was one of the first such studies conducted on Saudi patients and of their acceptance for such technology in their diabetes self-management treatment plans . CONCLUSIONS The pilot study of the SAED system showed that a mobile health technology can significantly improve the HbA1C levels among Saudi diabetic and improve their disease management plans . The SAED system can also be an effective and low-cost solution in improving the quality of life of diabetic patients in \n Output:\n " }, { "from": "agent", "value": "Conclusions : The development of an m-Health application could become a complementary monitoring tool during palliative care .\nHowever , it seems important to question the impact of technique in the professional – patient relationship and avoid the pitfalls of st and ardizing palliative care and reducing the patient to a “ sick ” health technician ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To determine perioperative morbidity , survival , and local failure rates in a large group of consecutive patients with rectal cancer undergoing low anterior resection by multiple surgeons on a specialty service . The primary objective was to assess the surgical complications associated with preoperative radiation sequencing . SUMMARY BACKGROUND DATA The goals in the treatment of rectal cancer are cure , local control , and preservation of sphincter , sexual , and bladder function . Surgical resection using sharp perimesorectal dissection is important for achieving these goals . The complications and mortality rate of this surgical strategy , particularly in the setting of preoperative chemoradiation , have not been well defined . METHODS There were 1233 patients with primary rectal cancer treated at the authors ' cancer center from 1987 to 1995 . Of these , 681 underwent low anterior resection and /or coloanal anastomosis for primary rectal cancer . The surgical technique used the principles of sharp perimesorectal excision . Morbidity and mortality rates were compared between patients receiving preoperative chemoradiation ( Preop RT , n = 150 ) and those not receiving preoperative chemoradiation ( No Preop RT , n = 531 ) . Recurrence and survival data were determined in patients undergoing curative resection ( n = 583 , 86 % ) among three groups of patients : those receiving Preop RT ( n = 131 ) , those receiving postoperative chemoradiation ( Postop RT , n = 110 ) , and those receiving no radiation therapy ( No RT , n = 342 ) . RESULTS The perioperative mortality rate was 0.6 % ( 4/681 ) . Postoperative complications occurred in 22 % ( 153/681 ) . The operative time , estimated blood loss , and rate of pelvic abscess formation without associated leak were higher in the Preop RT group than the No Preop RT group . However , the overall complication rate , rate of wound infection , anastomotic leak , and length of hospital stay were no different between Preop RT and No Preop RT patients . With a median follow-up of 45.6 months , the overall actuarial 5-year recurrence rate for patients undergoing curative resection ( n = 583 ) was 19 % , with 4 % having local recurrence only , 12 % having distant recurrence , and 3 % having both local and distant recurrence , for an overall local recurrence rate of 7 % . The actuarial 5-year overall survival rate was 81 % ; the disease-free survival rate was 75 % and the local recurrence rate was 10 % . The overall survival rate was similar between Preop RT ( 85 % ) , Postop RT ( 72 % ) , and No RT ( 83 % ) patients ( p = 0.10 ) , whereas the disease-free survival rate was significantly worse for Postop RT ( 65 % ) patients compared with Preop RT ( 79 % ) and No RT ( 77 % ) patients ( p = 0.04 ) . CONCLUSION The use of preoperative chemoradiation results in increased operative time , blood loss , and pelvic abscess formation but does not increase the rate of anastomotic leaks or the length of hospital stay after low anterior resection for rectal cancer . The 5-year actuarial overall survival rate for patients undergoing curative resection exceeded 80 % , with a local recurrence rate of 10 % Aim The st and ard treatment for patients with clinical ly resectable rectal cancer is surgery . Postoperative radiochemotherapy ( RCT ) is recommended for advanced disease ( pT3/4 or pN+ ) . In recent years , encouraging results of pre‐operative radiotherapy have been reported . This prospect i ve r and omized phase‐III‐trial ( CAO/ARO/AIO‐94 ) compares the efficacy of neoadjuvant RCT to st and ard postoperative RCT . We report on the design of the study and first results with regard to toxicity of RCT and postoperative morbidity Introduction Total mesorectal excision ( TME ) with preoperative chemoradiation therapy is an accepted st and ard treatment for low rectal cancer . Although the laparoscopic approach is accepted for the treatment of colon cancer , its value for low rectal cancer is unknown . The purpose of this study was to evaluate whether preoperative chemoradiation therapy exerted an adverse influence on laparoscopic TME for low rectal cancer . Methods We studied 125 consecutive patients who underwent laparoscopic TME for low rectal cancer . Twenty patients with preoperative chemoradiation therapy ( CRT-Lap group ) were compared with 105 patients without chemoradiation therapy ( non-CRT-Lap group ) . Results Operating time in the CRT-Lap group ( 276 min , range 160–390 min ) was no different from that in the non-CRT-Lap group ( 263 min , range 143–456 min ) . The CRT-Lap group had more blood loss during the operation ( 70 vs. 37 ml ) , but mean blood loss was < 100 ml . The distal tumor margin was longer in the CRT-Lap group ( 25.8 vs. 18.6 mm ) . The number of lymph node harvested did not differ between the groups ( 14.5 vs. 15.4 ) . Conversion to open surgery was necessary only in one case in the non-CRT-Lap group . There was no anastomotic leakage in the CRT-Lap group , whereas three patients ( 3.1 % ) had anastomotic leakage in the non-CRT-Lap group . Conclusion Laparoscopic TME with preoperative chemoradiation therapy is a safe procedure with reasonable operating time and does not appear to pose any threat to the surgical and oncologic outcomes Summary Background Preoperative or postoperative radiotherapy reduces the risk of local recurrence in patients with operable rectal cancer . However , improvements in surgery and histopathological assessment mean that the role of radiotherapy needs to be reassessed . We compared short-course preoperative radiotherapy versus initial surgery with selective postoperative chemoradiotherapy . Methods We undertook a r and omised trial in 80 centres in four countries . 1350 patients with operable adenocarcinoma of the rectum were r and omly assigned , by a minimisation procedure , to short-course preoperative radiotherapy ( 25 Gy in five fractions ; n=674 ) or to initial surgery with selective postoperative chemoradiotherapy ( 45 Gy in 25 fractions with concurrent 5-fluorouracil ) restricted to patients with involvement of the circumferential resection margin ( n=676 ) . The primary outcome measure was local recurrence . Analysis was by intention to treat . This study is registered , number IS RCT N 28785842 . Findings At the time of analysis , which included all participants , 330 patients had died ( 157 preoperative radiotherapy group vs 173 selective postoperative chemoradiotherapy ) , and median follow-up of surviving patients was 4 years . 99 patients had developed local recurrence ( 27 preoperative radiotherapy vs 72 selective postoperative chemoradiotherapy ) . We noted a reduction of 61 % in the relative risk of local recurrence for patients receiving preoperative radiotherapy ( hazard ratio [ HR ] 0·39 , 95 % CI 0·27–0·58 , p<0·0001 ) , and an absolute difference at 3 years of 6·2 % ( 95 % CI 5·3–7·1 ) ( 4·4 % preoperative radiotherapy vs 10·6 % selective postoperative chemoradiotherapy ) . We recorded a relative improvement in disease-free survival of 24 % for patients receiving preoperative radiotherapy ( HR 0·76 , 95 % CI 0·62–0·94 , p=0·013 ) , and an absolute difference at 3 years of 6·0 % ( 95 % CI 5·3–6·8 ) ( 77·5 % vs 71·5 % ) . Overall survival did not differ between the groups ( HR 0·91 , 95 % CI 0·73–1·13 , p=0·40 ) . Interpretation Taken with results from other r and omised trials , our findings provide convincing and consistent evidence that short-course preoperative radiotherapy is an effective treatment for patients with operable rectal cancer . Funding Medical Research Council ( UK ) and the National Cancer Institute of Canada BACKGROUND In many patients with rectal cancer , defunctioning stomas are created to limit the consequences of anastomotic leakage . Although intended to be temporary , a substantial proportion of these stomas might never be reversed for various reasons . We aim ed to describe stoma policy by use of data from the total mesorectal excision ( TME ) trial in patients with rectal cancer and to identify factors that limit stoma reversal . METHODS 924 Dutch patients with rectal cancer who underwent a low anterior resection were selected from the TME trial , a prospect i ve , r and omised multicentre trial study ing the effects of short-term preoperative radiotherapy in 1861 patients who underwent TME . Creation of stomas and time to stoma reversal were analysed retrospectively by use of multivariate analysis . FINDINGS In 523 of 924 ( 57 % ) patients , a primary stoma ( defined as a stoma created at the time of TME ) was constructed after a low anterior resection . Geographical differences in the number of primary stomas constructed were reported throughout the Netherl and s. 19 % of stomas that were created were never reversed . Postoperative complications and secondary constructed stomas ( defined as a stoma created during a second or subsequent procedure after TME ) were associated with a high likelihood of a permanent stoma . However , perioperative complications were not a limiting factor for stoma closure . INTERPRETATION Postoperative complications are an important limiting factor for stoma reversal because , after occurrence of these complications , patients and surgeons might be reluctant to reverse the stoma , so a substantial proportion of these stomas are never closed . Future guidelines for stoma creation and closure should consider these factors BACKGROUND We and others have shown that angiogenesis and leukocyte infiltration are important prognostic factors in rectal cancer . However , little is known about its possible changes in response to radiotherapy ( RTX ) , which is frequently given to rectal tumors as a neoadjuvant treatment to improve the prognosis . We therefore investigated the biologic effects of RTX on these parameters using fresh-frozen biopsy sample s of tumor and normal mucosa tissue before and after RTX . METHODS Biopsy sample s were taken from a total of 34 patients before and after either a short course or long course of RTX combined with chemotherapy . The following parameters were analyzed by immunohistochemistry , flow cytometry , or quantitative real-time polymerase chain reaction : Microvessel density , leukocyte infiltration , proliferating epithelial and tumor cells , proliferating endothelial cells , adhesion molecule expression on endothelial cells , and the angiogenic mRNA profile . RESULTS The tumor biopsy sample s taken after RTX treatment demonstrated a significant decrease in microvessel density and the number of proliferating tumor cells and proliferating endothelial cells ( p < 0.001 ) . In contrast , the leukocyte infiltration , the levels of basic fibroblast growth factor in carcinoma tissue , and the adhesion molecule expression on endothelial cells in normal as well as carcinoma tissue increased significantly ( p < 0.05 ) . CONCLUSION Our data show that together with an overall decrease in tumor cell and endothelial cell proliferation , RTX results in an increase in the expression of adhesion molecules that stimulate leukocyte infiltration . This suggests the possibility that , in addition to its direct cytotoxic effect , radiation may also stimulate an immunologic tumor response that could contribute to the documented improvement in local tumor control and distal failure rate of rectal cancers Although many trials have shown the efficacy of preoperative chemoradiotherapy ( CRT ) or postoperative CRT compared with surgery alone , the optimal sequence of radiotherapy and surgery is unclear . The authors reported the final results of this single institution prospect i ve r and omized phase 3 trial comparing preoperative CRT with postoperative CRT using capecitabine in survival , local control , sphincter preservation , and toxicity for the treatment of locally advanced rectal cancer Purpose This study was undertaken to determine whether neoadjuvant radiotherapy is associated with an increased risk of anastomotic leak for rectal cancer patients undergoing restorative resection . Methods From 1980 to 2010 , patients who underwent restorative resection for rectal cancer ( tumors within 15 cm of anal verge ) were identified from a prospect i ve institutional data base and grouped based on whether they received neoadjuvant radiotherapy ( + RT ) or not ( −RT ) . The main outcome was anastomotic leak documented by imaging ( contrast leak ) , intra-operative or clinical ( signs of peritonitis ) findings and confirmed by staff surgeon assessment . Using multivariate ( MV ) analysis risk factors for leak were identified , presented as OR ( 95 % CI ) . Results One thous and eight hundred sixty-two patients were included in the analysis , 28 % in the + RT group . Eighty-six percent of + RT patients received neoadjuvant chemoradiotherapy . The overall leak rate was 6.3 % , with no significant difference in + RT and −RT groups ( 8 % vs 5.7 % , p = 0.06 ) . The + RT group had a lower mean age at surgery ( 58 vs 63 year , p < 0.001 ) \n Output:\n " }, { "from": "agent", "value": "The interval to surgery after neoadjuvant therapy and preoperative radiotherapy ( short or long course ) was not associated with an increased incidence of postoperative AL .\nConclusion Neoadjuvant therapy does not appear to increase the incidence of postoperative AL after anterior resection for mid and low rectal cancer .\nIn addition , neither the interval to surgery after neoadjuvant therapy nor the radiotherapy regimen increases the rate of postoperative AL" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The proximal femoral nail ( PFN ) is a recently introduced intramedullary system , design ed to improve treatment of unstable trochanteric fractures of the hip . In a multicentre prospect i ve clinical study , the intra-operative use , complications and outcome of treatment using the PFN ( n = 211 ) were compared with those using the gamma nail ( GN ) ( n = 213 ) . The intra-operative blood loss was lower with the PFN ( 220 ml v 287 ml , p = 0.001 ) . Post-operatively , more lateral protrusion of the hip screws of the PFN ( 7.6 % ) was documented , compared with the gamma nail ( 1.6 % , p = 0.02 ) . Most local complications were related to suboptimal reduction of the fracture and /or positioning of the implant . Functional outcome and consolidation were equal for both implants . Generally , the results of treatment of unstable trochanteric fractures were comparable for the PFN and GN . The pitfalls and complications were similar , and mainly surgeon- or fracture-related , rather than implant-related Objective To determine the mortality risk following hip fracture and identify factors predictive of increased mortality . Design Retrospective review of prospect ively collected data . Setting Tertiary care orthopaedic hospital . Background Approximately 250,000 hip fractures occur annually in the United States . The greatest mortality risk following hip fracture has been demonstrated to be within the first 6 months of fracture , and some studies report that the risk approaches expected mortality after 6 months . However , more recent studies have demonstrated that an increased risk of mortality may persist for several years postfracture . The purpose of this study was to assess the excess mortality associated with hip fracture at up to 2 years postinjury . Methods All patients with a hip fracture who were admitted to our institution over a 10-year period were evaluated . Criteria for inclusion included : Caucasian , age 65 or older , previously ambulatory , and home dwelling . Patients were followed prospect ively to determine the mortality risk associated with hip fracture over a 2-year follow-up period . Mortality was compared to a st and ardized population and st and ardized mortality ratios were calculated . Results Eight hundred thirty-six patients met the inclusion criteria and were included . The mortality risk was highest within the first 3 months following fracture , with st and ardized mortality ratios approaching that of the control population by two years . Patients age 65–84 had higher mortality risk when compared with patients age ≥85 . American Society of Anesthesiologists classification was predictive of increased mortality risk in younger patients , with these patients having triple the mortality risk when compared to the reference population at 2-year follow-up . More elderly patients had minimal excess mortality associated with hip fracture at 1- and 2-year follow-up , regardless of ASA classification . Conclusion The data demonstrate that hip fracture is not associated with significant excess mortality amongst patients older than age 85 . Amongst younger patients , however , those with ASA classifications of 3 or 4 have significant excess mortality following hip fracture that persists up to 2 years after injury Objectives : We sought to examine the relationship between functional outcome and process of care for patients with hip fracture . Research Design and Participants : We undertook a prospect i ve cohort study in 4 hospitals of 554 patients treated with surgery for hip fracture . Measurements : Information on patient characteristics and processes of hospital care collected from the medical record , interviews , and bedside observations . Follow-up information obtained at 6 months on function ( using the Functional Independence Measure [ FIM ] ) , survival , and readmission . Results : Individual processes of care were generally not associated with adjusted outcomes . A scale of 9 processes related to mobilization was associated with improved adjusted locomotion ( P = 0.006 ) , self care ( P = 0.022 ) , and transferring ( P = 0.007 ) at 2 months , but the benefits were smaller and not significant by 6 months . These processes were not associated with mortality . The predicted value for the FIM locomotion measure ( range , 2–14 ) at 2 months was 5.9 ( 95 % confidence interval 5.4–6.4 ) for patients at the 10th percentile of performance on these processes compared with 7.1 ( 95 % confidence interval 6.6 , 7.6 ) at the 90th percentile . Patients who experienced no hospital complications and no readmissions retained the benefits in locomotion at 6 months . Anticoagulation processes were associated with improved transferring at 2 months ( P = 0.046 ) but anticoagulation and other processes of care were not otherwise associated with improved function . Discussion : Our findings indicate the need to attend to all steps in the care of patients with hip fracture . Additionally , functional outcomes were more sensitive markers of improved process of care , compared with 6-month mortality , in the case of hip fracture OBJECTIVES To identify determinants of mortality and institutionalization after hip fracture and to identify those older hip fracture patients at high risk of death or institutionalization after hip fracture . DESIGN Population -based prospect i ve inception cohort study of hip fracture patients ; patients were assessed in the hospital and at 3 months following the hip fracture . SETTING Edmonton area hip fracture patients admitted to one of two Edmonton , Alberta , Canada , acute care centers between July 10 , 1996 , and August 31 , 1997 . PARTICIPANTS Patients were residents of the Edmonton area and over the age of 64 . Those who had previously fractured the same hip within the past 5 years or had some pathological condition underlying the hip fracture were excluded . Of 610 eligible patients , 558 contributed some baseline information and were included in the mortality analysis ; the institutionalization analysis was restricted to the 338 patients who lived in the community before fracture , survived the 3-month period postfracture , and had completed a 3-month follow-up interview . MEASUREMENTS The baseline interview was done in the hospital to assess mental status , prefracture physical function , prefracture health perception , and prefracture social support . The 3-month follow-up interview was done by phone to assess physical function , health perception , and social support 3 months postfracture . Demographic and comorbidity information was collected from medical records . RESULTS Low mental status in hospital was found to increase the chances of mortality and institutionalization , and male gender was found to increase mortality risk fourfold . Each additional 10 years of age increased the risk of institutionalization approximately 2.5 times . Patients with lower postfracture physical function had at least five times the risk of institutionalization compared to patients with high postfracture physical function . CONCLUSIONS Cognitive impairment , older age , and gender were associated with increased risk of poor outcome following hip fracture . The socioeconomic variables -- social support and health perception -- did not contribute significant additional information in explaining mortality or institutionalization risk . While demographic factors can not be modified , physical function 3 months postfracture may be amenable to intervention and may reduce the risk of institutionalization . Intervening to increase postfracture physical function may be particularly beneficial to older patients , or to those who are cognitively impaired This prospect i ve r and omized trial compared the efficacy of unipolar versus bipolar hemiarthroplasty in elderly patients ( ≥ 65 years ) with displaced femoral neck fractures in terms of quality of life and functional outcomes . One hundred fifteen patients with a mean age of 82.1 years were enrolled in this study and r and omized to either unipolar or bipolar hemiarthroplasty . Quality of life and functional outcomes were assessed using the Musculoskeletal Functional Assessment instrument and Short Form-36 health survey . Seventy-eight patients completed 1 year of followup . There were no differences between the groups in estimated blood loss , length of hospital stay , mortality rate , number of dislocations , postoperative complications , or ambulatory status at 1 year . There also were no significant differences between the two groups at either point in postoperative Short Form-36 or Musculoskeletal Functional Assessment instrument scores . Results of this prospect i ve r and omized study suggest that the bipolar endoprosthesis provides no advantage in the treatment of displaced femoral neck fractures in elderly patients regarding quality of life and functional outcomes A prospect i ve , r and omized trial of 104 consecutive patients with displaced fractures of the femoral neck treated with either a sliding screw plate or four AO cancellous bone screws was performed to study the influence of the fixation device and the fixation procedure on the vascularity of the femoral head . The vitality of the femoral head was determined by 99mTc-MDP scintigraphy performed 2 - 3 months after the operation . Eighty-seven patients ( 84 per cent ) were available for assessment . The two treatment groups were comparable with regard to age , degree of primary displacement and quality of reduction . There were significantly more ( P less than 0.01 ) avascular femoral heads or femoral heads with reduced vascularity in the sliding screw plate group ( 14/40 , 35 per cent ) than in the four AO cancellous bone screw group ( 5/47 , 11 per cent ) 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 surgery . Interventions Routine care for hip fractures . Main outcome measures Postoperative complications and mortality at 30 days and one year . Results Mortality was 9.6 % at 30 days and 33 % at one year . The most common postoperative complications were chest infection ( 9 % ) and heart failure ( 5 % ) . In patients who developed postoperative heart failure mortality was 65 % at 30 days ( hazard ratio 16.1 , 95 % confidence interval 12.2 to 21.3 ) . Of these patients , 92 % were dead by one year ( 11.3 , 9.1 to 14.0 ) . In patients who developed a postoperative chest infection mortality at 30 days was 43 % ( 8.5 , 6.6 to 11.1 ) . Significant preoperative variables for increased mortality at 30 days included the presence of three or more comorbidities ( 2.5 , 1.6 to 3.9 ) , respiratory disease ( 1.8 , 1.3 to 2.5 ) , and malignancy ( 1.5 , 1.01 to 2.3 ) . Conclusions In elderly people with hip fracture , the presence of three or more comorbidities is the strongest preoperative risk factor . Chest infection and heart failure are the most common postoperative complications and lead to increased mortality . These groups offer a clear target for specialist medical assessment We analysed the time-dependent mean changes in the femoral neck length , neck-shaft angle and hip offset in a r and omised study comprising 48 patients who were treated with the dynamic hip screw ( DHS ) or the proximal femoral nail ( PFN ) for an unstable intertrochanteric femoral fracture . As a consequence of fracture compression , the mean post-operative neck length was significantly shorter in patients treated with the DHS . During the first 6 weeks after the operation , a mean decrease of 4.6 ° was observed in the neck-shaft angle , but there was not a significant difference between the treatment groups . The radiographic measures remained virtually unaffected during the interval from 6 weeks to 4 months in both groups . When the operated hip was compared to the opposite hip , patients who had received the DHS showed significantly greater medialisation of the femoral shaft at 4 months than those treated with the PFN . We thus recommend that unstable intertrochanteric fractures should be initially reduced in a slight valgus position in order to achieve an outcome after healing that is as normal as possible . As a result of differences in operative technique and implant stability , the PFN may be superior to the DHS in retaining the anatomical relations in the hip region in unstable intertrochanteric fractures . RésuméNous avons analysé les modifications , en fonction du temps , des valeurs moyennes de la longueur du col fémoral , de l’angle cervico-diaphysaire et du bras de levier de la hanche dans une étude r and omisée qui comprenait 48 malades traités avec une Vis Dynamique ( DHS ) ou un Clou Fémoral Proximal ( PFN ) aprés une fracture intertrochantérienne instable . Par suite de la compression de la fracture , la longueur du col était nettement plus courte chez les malades traités avec une DHS . Pendant les premières six semaines après l’opération , une baisse moyenne de 4.6 ° de l’angle cervico-diaphysaire a été observée mais il n’y avait pas de différence notable entre les groupes de traitement . Les mesures radiographiques sont restées pratiquement non affectées pendant l’intervalle de six semaines à quatre mois dans les deux groupes . Comparé à la hanche opposée , les malades qui avaient reçu une DHS ont montré à 4 mois une nettement plus gr and e médialisation de la diaphyse que ceux traités avec le PFN . Nous recomm and ons que ces fractures intertrochantériennes instables soient réduites en léger valgus pour avoir une situation aussi norm \n Output:\n " }, { "from": "agent", "value": "Fracture type does not appear to be independently related to patient outcomes .\nMortality , pain , function , and quality of life did not differ by surgical implant class , or by implants within a class ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: More effective therapeutic strategies are required for patients with poor-prognosis systemic sclerosis ( SSc ) . A phase 2 single-arm study of high-dose immunosuppressive therapy ( HDIT ) and autologous CD34-selected hematopoietic cell transplantation ( HCT ) was conducted in 34 patients with diffuse cutaneous SSc . HDIT included total body irradiation ( 800 cGy ) with lung shielding , cyclophosphamide ( 120 mg/kg ) , and equine antithymocyte globulin ( 90 mg/kg ) . Neutrophil and platelet counts were recovered by 9 ( range , 7 to 13 ) and 11 ( range , 7 to 25 ) days after HCT , respectively . Seventeen of 27 ( 63 % ) evaluable patients who survived at least 1 year after HDIT had sustained responses at a median follow-up of 4 ( range , 1 to 8) years . There was a major improvement in skin ( modified Rodnan skin score , -22.08 ; P < .001 ) and overall function ( modified Health Assessment Question naire Disability Index , -1.03 ; P < .001 ) at final evaluation . Importantly , for the first time , biopsies confirmed a statistically significant decrease of dermal fibrosis compared with baseline ( P < .001 ) . Lung , heart , and kidney function , in general , remained clinical ly stable . There were 12 deaths during the study ( transplantation-related , 8 ; SSc-related , 4 ) . The estimated progression-free survival was 64 % at 5 years . Sustained responses including a decrease in dermal fibrosis were observed exceeding those previously reported with other therapies . HDIT and autologous HCT for SSc should be evaluated in a r and omized clinical trial Autologous hematopoietic stem cell transplantation ( HSCT ) utilizing a myeloablative regimen containing total body irradiation has been performed in patients with systemic sclerosis ( SSc ) , but with substantial toxicity . We , therefore , conducted a phase I non-myeloablative autologous HSCT study in 10 patients with SSc and poor prognostic features . PBSC were mobilized with CY and G-CSF . The PBSC graft was cryopreserved without manipulation and re-infused after the patient was treated with a non-myeloablative conditioning regimen of 200 mg/kg CY and 7.5 mg/kg rabbit antithymocyte globulin . There was a statistically significant improvement of modified Rodnan skin score whereas cardiac ( ejection fraction , pulmonary arterial pressure ) , pulmonary function ( DLCO ) and renal function ( creatinine ) remained stable without significant change . One patient with advanced disease died 2 years after the transplant from progressive disease . After median follow-up of 25.5 months , the overall and progression-free survival rates are 90 and 70 % respectively . Autologous HSCT utilizing a non-myeloablative conditioning regimen appears to result in improved skin flexibility similar to a myeloablative TBI containing regimen , but without the toxicity and risks associated with TBI BACKGROUND Non-r and omised studies of haemopoietic stem-cell transplantation ( HSCT ) in systemic sclerosis have shown improvements in lung function and skin flexibility but high treatment-related mortality . We aim ed to assess safety and efficacy of autologous non-myeloablative HSCT in a phase 2 trial compared with the st and ard of care , cyclophosphamide . METHODS In our open-label , r and omised , controlled phase 2 trial , we consecutively enrolled patients at Northwestern Memorial Hospital ( Chicago , IL , USA ) who were aged younger than 60 years with diffuse systemic sclerosis , modified Rodnan skin scores ( mRSS ) of more than 14 , and internal organ involvement or restricted skin involvement ( mRSS < 14 ) but coexistent pulmonary involvement . We r and omly allocated patients 1:1 by use of a computer-generated sequence with a mixed block design ( blocks of ten and four ) to receive HSCT , 200 mg/kg intravenous cyclophosphamide , and 6·5 mg/kg intravenous rabbit antithymocyte globulin or to receive 1·0 g/m(2 ) intravenous cyclophosphamide once per month for 6 months . The primary outcome for all enrolled patients was improvement at 12 months ' follow-up , defined as a decrease in mRSS ( > 25 % for those with initial mRSS > 14 ) or an increase in forced vital capacity by more than 10 % . Patients in the control group with disease progression ( > 25 % increase in mRSS or decrease of > 10 % in forced vital capacity ) despite treatment with cyclophosphamide could switch to HSCT 12 months after enrolment . This study is registered with Clinical Trials.gov , number NCT00278525 . FINDINGS Between Jan 18 , 2006 , and Nov 10 , 2009 we enrolled 19 patients . All ten patients r and omly allocated to receive HSCT improved at or before 12 months ' follow-up , compared with none of nine allocated to cyclophosphamide ( odds ratio 110 , 95 % CI 14·04-∞ ; p=0·00001 ) . Eight of nine controls had disease progression ( without interval improvement ) compared with no patients treated by HSCT ( p=0·0001 ) , and seven patients switched to HSCT . Compared with baseline , data for 11 patients with follow-up to 2 years after HSCT suggested that improvements in mRSS ( p<0·0001 ) and forced vital capacity ( p<0·03 ) persisted . INTERPRETATION Non-myeloablative autologous HSCT improves skin and pulmonary function in patients with systemic sclerosis for up to 2 years and is preferable to the current st and ard of care , but longer follow-up is needed . FUNDING None OBJECTIVE The aim of this study was to find a new and less cardiotoxic conditioning regimen for high-dose chemotherapy and autologous stem cell transplantation ( aSCT ) in patients with severe SSc and pre-existing cardiac involvement . METHODS Six patients with cardiac involvement were treated for SSc with a conditioning regimen including reduced-dose CYC plus the non-cardiotoxic alkylant thiotepa . All patients received an implantable cardioverter defibrillator ( ICD ) before aSCT . The response at months 6 and 12 was measured according to reduction of the modified Rodnan skin score ( mRSS ) . CT histography was used to monitor pulmonary manifestations , as were echocardiography , N-terminal pro-brain natriuretic peptide ( NT-proBNP ) and troponin for the cardiac involvement . Cardiac events were defined as death or hospitalisation due to heart failure or appropriate discharge of the ICD . RESULTS Between December 2008 and May 2012 , four male and two female patients with a median age of 41 years received aSCT . The median mRSS significantly decreased from 26.5 to 18 and 17.5 at month 6 and 12 , respectively . The total lung volume also significantly improved . Within the median follow-up of 1.6 years ( range 1 - 3.8 ) two patients experienced a relapse of SSc , which results in a progression-free survival rate of 66.6 % . Three patients experienced ICD discharge . CONCLUSION For patients with SSc and cardiac involvement , the use of thiotepa and reduced-dose CYC is feasible and effective . The rate of ICD discharge underlines the need for protection in these endangered patients . This preliminary experience allowed us to use this regimen for our currently recruiting prospect i ve trial ( NCT01895244 ) Objective : Systemic sclerosis ( SSc ) is a generalised autoimmune disease , causing morbidity and a reduced life expectancy , especially in patients with rapidly progressive diffuse cutaneous SSc . As no proven treatment exists , autologous haematopoietic stem cell transplantation ( HSCT ) is employed as a new therapeutic strategy in patients with a poor prognosis . This study reports the effects on survival , skin and major organ function of HSCT in patients with severe diffuse cutaneous SSc . Patients and methods : A total of 26 patients were evaluated . Peripheral blood stem cells were collected using cyclophosphamide ( 4 g/m2 ) and rHu G-CSF ( 5 to 10 μg/kg/day ) and were reinfused after positive CD34 + selection . For conditioning , cyclophosphamide 200 mg/kg was used . Results : After a median follow-up of 5.3 ( 1–7.5 ) years , 81 % ( n = 21/26 ) of the patients demonstrated a clinical ly beneficial response . The Kaplan – Meier estimated survival at 5 years was 96.2 % ( 95 % CI 89–100 % ) and at 7 years 84.8 % ( 95 % CI 70.2–100 % ) and event-free survival , defined as survival without mortality , relapse or progression of SSc , result ing in major organ dysfunction was 64.3 % ( 95 % CI 47.9–86 % ) at 5 years and 57.1 % ( 95 % CI 39.3–83 % ) at 7 years . Conclusion : This study confirms that autologous HSCT in selected patients with severe diffuse cutaneous SSc results in sustained improvement of skin thickening and stabilisation of organ function up to 7 years after transplantation \n Output:\n " }, { "from": "agent", "value": "All the studies showed an improvement in mRSS .\nWe conclude that ASCT is beneficial in some patients with SSc and that patient selection and conditioning regimens are critical determinants of prognosis and mortality post-ASCT" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose To establish whether bipolar transurethral resection of tumours ( bTURB ) on the lateral bladder wall is superior to monopolar transurethral resection ( mTURB ) of such tumours . To our knowledge , this is the first prospect i ve r and omised study , which defines complete resection depending on obturator jerk as primary endpoint . Methods In a prospect i ve , r and omised , single centre study , 52 patients with newly diagnosed or recurrent bladder tumour on the lateral bladder wall were enrolled and r and omised to undergo mTURB or bTURB ; 44 patients were eligible for analysis , of whom 21 underwent mTURB and 23 bTURB . Any differences between the two techniques related to the incidence of unwanted stimulation of the obturator nerve and subsequent adductor spasms were evaluated . All procedures were carried out under laryngeal mask anaesthesia without obturator nerve block ( ONB ) and without drug-induced relaxation . Results Baseline characteristics of the two study groups did not differ statistically significantly . The success rate defined as complete resection of the bladder tumour without any clinical ly relevant adductor spasm was 61.9 % in the monopolar group and 82.6 % in the bipolar group ( p = 0.18 ) . Conclusions Complete , undisturbed resection of tumours of the lateral bladder wall is feasible with mTURB and bTURB . Adductor spasms due to obturator jerk can occur suddenly with the risk of bladder perforation . We therefore support ONB when using spinal anaesthesia and drug-induced relaxation when using general anaesthesia when performing TURB on the lateral bladder wall ABSTRACT Introduction : To compare the perioperative outcomes and complications of monopolar and bipolar transurethral resection of bladder tumors ( TURBT ) in patients with coronary artery disease ( CAD ) . Material s and Methods : A total of 90 CAD patients with newly diagnosed bladder cancer who underwent TURBT were r and omized into monopolar TURBT ( M-TURBT ) and bipolar TURBT ( B-TURBT ) groups . Primary outcome was safety of the procedures including obturator jerk , bladder perforation , clot retention , febrile urinary tract infection and TUR syndrome . The secondary outcome was the efficacy of TURBT procedures , including complete tumor resection , sampling of the deep muscle tissue and sampling of the qualified tissues without any thermal damage . Results : Mean ages of the patients in M-TURBT and B-TURBT groups were 71.36±7.49 and 73.71±8.15 years , respectively ( p=0.157 ) . No significant differences were found between M-TURBT and B-TURBT groups regarding complete tumor resection ( 76.2 % vs. 87.5 % , p=0.162 ) and muscle tissue sampling rates ( 71.4 % vs. 64.6%,p=0.252 ) . Obturator jerk was detected in 16.7 % of the patients in M-TURBT group and 2.1 % in B-TURBT group ( p=0.007 ) . No statistically significant differences were found between the groups regarding intraoperative and postoperative complications . Conclusions : Both monopolar and bipolar systems can be used safely and effectively during TURBT procedure in CAD patients . Due to the more frequently seen obturator jerk in M-TURBT than B-TURBT , careful surgical approach is needed during M-TURBT 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 Abstract Objective : To compare the safety and efficacy of bipolar vs monopolar transurethral resection of bladder tumour ( TURBT ) in patients maintained on low-dose aspirin with tumours > 3 cm . Patients and methods : A prospect i ve r and omised single-centre study was performed including 200 patients with bladder tumours of > 3 cm , as measured by ultrasonography . All patients were using low-dose aspirin ( 81 mg/day ) , which was not stopped in the perioperative period . Patients were r and omised into two groups : Group A , monopolar TURBT ( M-TURBT ) ; Group B , bipolar TURBT ( B-TURBT ) . The primary endpoint of the study was the decrease in postoperative haemoglobin ( Hb ) concentration measured using an automated cell counter . The secondary endpoints of the study were intraoperative blood transfusion or the occurrence of urethral trauma during cystoscopy and the need for re-coagulation . Results : The postoperative reduction in Hb concentration , was significantly lower in the B-TURBT group [ mean ( SD ) 0.55 ( 0.26 ) g/dL ] compared with the M-TURBT group [ mean ( SD ) 1.24 ( 0.61 ) g/dL ] ( P < 0.001 ) . There was also a significant difference ( in favour of B-TURBT ) between the groups in the mean postoperative reduction in haematocrit and the mean postoperative hospital stay . There was no significant difference between the groups for the occurrence of obturator jerk , bladder perforation , and the need for blood transfusion . Conclusion : B-TURBT in patients maintained on low-dose aspirin is better than M-TURBT for minimising postoperative drop in Hb concentration PURPOSE We compared the safety and efficacy of bipolar transurethral resection and monopolar resection for bladder tumors . MATERIAL S AND METHODS A single center , parallel arm , r and omized , controlled trial was performed from May 2011 to August 2012 . All patients with suspected bladder tumors were eligible for study inclusion . Those who refused consent and those undergoing routine restaging transurethral resection of bladder tumor were excluded from analysis . The primary end point was the incidence of obturator jerk . Secondary study outcomes included the decrease in hematocrit , rates of recoagulation and transfusion , bladder perforation , decrease in sodium , resection syndrome and resection time . Pathological quality was assessed by comparing deep muscle and the degree of severe cautery artifact in the 2 arms . RESULTS A total of 257 transurethral resections were performed during the study period . After exclusion 147 patients were r and omized , including 75 in the monopolar arm and 72 in the bipolar arm . There were 6 and 4 protocol violations in the monopolar and bipolar arms , respectively . Intent to treat and per protocol analyses were performed . The incidence of obturator jerk was greater in the bipolar arm ( 60 % vs 49.2 % , p=0.27 ) . There was no significant difference between secondary outcomes . The only significant difference was a significantly lower incidence of severe cautery artifact in the bipolar arm ( 25 % vs 46.7 % , p=0.0096 ) . CONCLUSIONS Bipolar transurethral resection of bladder tumor was not superior to monopolar resection with respect to obturator jerk , bladder perforation and hemostasis . There was a significantly lower incidence of severe cautery artifact after bipolar resection OBJECTIVES To compare the safety and the efficacy of plasmakinetic bipolar resectoscope versus conventional monopolar in the transurethral resection of primary non-muscle invasive bladder cancer . METHODS From January 2007 to December 2009 , 132 patients underwent endoscopic resection for primary non-muscle invasive bladder cancer . They were r and omly assigned to two groups : 67 patients underwent a transurethral resection of the bladder with bipolar plasmakinetic energy transurethral resection of the bladder and 65 were treated with conventional monopolar transurethral resection . RESULTS The mean operative time was 27 min for bipolar plasmakinetic energy transurethral resection of the bladder and 31 min for monopolar transurethral resection of the bladder . No significant differences in the mean change of hemoglobin and serum sodium level were observed . Mean catheterization time was 1.3 days and 2.3 days for bipolar plasmakinetic energy transurethral resection of the bladder and monopolar transurethral resection of the bladder , respectively . The mean hospital stay was shorter in the bipolar plasmakinetic energy transurethral resection of the bladder . Bladder perforation was reported in two cases for the monopolar transurethral resection of the bladder group and obturator nerve reflex occurred in a single case for both procedures . None of the patients experienced transurethral resection syndrome . The median time of bladder tumor recurrence after initial transurethral resection of the bladder was 12.4 months and 11.9 months for bipolar plasmakinetic energy transurethral resection of the bladder and monopolar transurethral resection of the bladder , respectively . No significant differences in the overall recurrence-free survival rate were observed comparing the two procedures . CONCLUSIONS Plasmakinetic bipolar transurethral resection represents a safe and effective procedure in the management of non-muscle invasive bladder cancer BACKGROUND AND PURPOSE Bipolar transurethral resection of bladder tumors ( TURBTs ) has been cl aim ed to have lesser complications and better specimen quality , but recent studies have contradictory results , and hence , we conducted this study to compare the clinical efficacy and safety of monopolar and bipolar electrosurgical modalities in TURBTs . MATERIAL S AND METHODS A total of 287 patients were enrolled in the study and underwent TURBTs between July 2015 and September 2016 . Patients undergoing surgery under general anesthesia and restage procedure were excluded from the study . Patient demographic profile , tumor characteristics , and complications of the procedures such as obturator jerk , bladder perforation , blood loss , need for resurgery , and transurethral resection syndrome were recorded . Tumor specimens were analyzed for stage , grade , deep muscle invasion , and quantity and quality of thermal artifacts . RESULTS A total of 160 patients were block r and omized and analyzed with 80 patients in either group . Patient demographics and tumor characteristics were comparable between the groups . Change in hemoglobin levels and incidence of bladder perforation were comparable between the groups . A higher proportion of patients in bipolar group had obturator jerk compared with those in monopolar group , however , it was not statistically significant ( 24 % vs 14 % ; p = 0.23 ) . A higher proportion of patients in bipolar group did not have thermal artifacts when compared with monopolar group ( 27.5 % vs 5 % ; p < 0.0001 ) . CONCLUSIONS The operative risks of bipolar TURBT such as obturator jerk , bladder perforation , and blood loss are comparable with monopolar resection . However , less thermal artifacts in tissue sample s obtained with bipolar resection may be helpful to the pathologist in interpretation of histopathologic findings \n Output:\n " }, { "from": "agent", "value": "Bipolar and monopolar devices are equally safe in terms of obturator jerk and bladder perforation ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Few medical therapies improve lower extremity functioning in people with lower extremity peripheral artery disease ( PAD ) . Among people with PAD , we studied whether a group-mediated cognitive behavioral intervention promoting home-based unsupervised exercise prevented mobility loss and improved functional performance compared to control . Methods and Results One hundred ninety-four PAD participants were r and omized . During months 1 to 6 , the intervention group met weekly with other PAD participants and a facilitator . Group support and self-regulatory skills were used to help participants adhere to walking exercise . Ninety-percent of exercise was conducted at or near home . The control group attended weekly lectures . During months 6 to 12 , each group received telephone contact only . Primary outcomes have been reported . Here we compare changes in exploratory outcomes of mobility loss ( the inability to climb a flight of stairs or walk one-quarter mile without assistance ) , walking velocity , and the Short Physical Performance Battery . Compared to controls , fewer participants r and omized to the intervention experienced mobility loss at 6-month follow-up : 6.3 % versus 26.5 % , P=0.002 , odds ratio=0.19 ( 95 % CI=0.06 to 0.58 ) and at 12-month follow-up : 5.2 % versus 18.5 % , P=0.029 , odds ratio=0.24 ( 95 % CI=0.06 to 0.97 ) . The intervention improved fast-paced 4-m walking velocity at 6-month follow-up ( P=0.005 ) and the Short Physical Performance Battery at 12-month follow-up ( P=0.027 ) , compared to controls . Conclusions In exploratory analyses , a group-mediated cognitive behavioral intervention promoting unsupervised walking exercise prevented mobility loss and improved functioning at 6- and 12-month follow-up in PAD patients . Clinical Trial Registration URL : http:// clinical trials.gov . Unique identifier : NCT00693940 We estimated minimal clinical ly important differences ( MCIDs ) for small , moderate , and large changes in measures obtained from a st and ardized treadmill test , a 6-minute walk test , and patient-based outcomes following supervised and home-based exercise programs in symptomatic patients with peripheral artery disease ( PAD ) . Patients were r and omized to either 12 weeks of a supervised exercise program ( n=60 ) , a home-based exercise program ( n=60 ) , or an attention-control group ( n=60 ) . Using the distribution-based method to determine MCIDs , the MCIDs for small , moderate , and large changes in peak walking time ( PWT ) in the supervised exercise group were 38 , 95 , and 152 seconds , respectively , and the changes in claudication onset time ( COT ) were 35 , 87 , and 138 seconds . Similar MCID scores were noted for the home-based exercise group . An anchor-based method to determine MCIDs yielded similar patterns of small , moderate , and large change scores in PWT and COT , but values were 1–2 minutes longer than the distribution approach . In conclusion , 3 months of supervised and home-based exercise programs for symptomatic patients with PAD results in distribution-based MCID small , moderate , and large changes ranging from 0.5 and 2.5 minutes for PWT and COT . An anchor-based approach yields higher MCID values , ranging from a minimum of 73 seconds for COT to a maximum of 4 minutes for PWT . The clinical implication is that a goal for eliciting MCIDs in symptomatic PAD patients through a walking exercise intervention is to increase PWT and COT by up to 4 minutes , which corresponds to two work stages during the st and ardized progressive treadmill test The aim of this study was to develop and pilot a group education programme for promoting walking in people with intermittent claudication . Patient focus groups ( n=24 ) and literature review s were conducted to inform the development of the education programme , which involves a three-hour group-based education workshop and follow-up telephone support . A pilot study was subsequently conducted in which 23 new patients ( Rutherford category 1–3 ) were r and omly assigned to usual care ( control ) or usual care plus the education programme . Outcomes were assessed at baseline and six weeks including daily steps ( tri-axial accelerometer ) , walking capacity ( six-minute walk test and Gardner treadmill test ) , and quality of life ( Intermittent Claudication Question naire [ ICQ ] ) . Exit interviews were conducted to assess the acceptability and usefulness of the programme . Compared with controls , the intervention group had superior walking capacity and quality of life at six weeks . Mean differences in six-minute walk distance , treadmill maximum walking distance and ICQ score were 44.9 m ( 95 % confidence interval [ CI ] , 6.9 to 82.9 ) , 173 m ( 95 % CI , 23 to 322 ) , and −10.6 ( 95 % CI , −18.9 to −2.3 ) , respectively . The daily step count did not differ between groups . The exit interviews indicated that participants valued attending the programme , that it gave them a greater underst and ing of their condition , and that they had been walking more for exercise since attending . The results suggest that the education programme is feasible , acceptable , and potentially useful for improving walking capacity and quality of life . A fully-powered trial exploring clinical and cost effectiveness is needed . TRIAL REGISTRATION NUMBER : IS RCT N06733130 ( http://www.controlled-trials.com ) The aims of the study were to determine whether heart rate variability ( HRV ) measured at rest and during exercise could be altered by an exercise training programme design ed to increase walking performance in patients with peripheral arterial disease . Forty-four volunteers were r and omised into 12 weeks of either : supervised walking training twice weekly for 30 min at 75 % VO2peak ( SU ) , home-based walking training sessions : twice weekly , 30 min per week ( HB ) or no exercise ( CT ) . HRV measures were calculated from a 5-min resting ECG . Each patient then underwent maximal , grade d exercise treadmill testing . All measures were repeated after 12 weeks . The SU group showed significantly ( p < 0.001 ) increased maximal walking time ( MWT ) but no change in VO2peak . There were no statistically significant changes in any of the measures of HRV in any group . Effect sizes for change in HRV measures were all very small and in some cases negative . Improved walking performance was not accompanied by central cardiorespiratory or neuroregulatory adaptations in the present study . The lack of any change in HRV was possibly due to either the low intensity or discontinuous nature of exercise undertaken . Key pointsIt is known that exercise can positively influence heart rate variability in some cardiac patients .It is known that exercise can increase walking performance in peripheral vascular disease patients .Exercise training improved walking performance in peripheral vascular disease patients but HRV was unaltered . This may be due to low overall physiological dem and s on the cardiovascular system or the intermittent nature of the exercise OBJECTIVE Determine the efficacy of a home-based walking intervention to improve walking ability and quality of life in people with diabetes and peripheral arterial disease ( PAD ) . RESEARCH DESIGN AND METHODS We conducted a r and omized , controlled , single-blind trial within university-affiliated clinics in our local community . We r and omized 145 participants ( 45 women ) with diabetes and PAD to our intervention — a 6-month behavioral intervention targeting levels of readiness to engage in routine walking for exercise — versus attention control . Our primary outcome was 6-month change in maximal treadmill walking distance . Secondary outcomes included 3-month change in maximal walking distance , lower limb function ( i.e. , walking impairment scores ) , quality of life ( Medical Outcomes Short Form Survey ) , exercise behaviors , depressive symptoms , and self-efficacy at 3 and 6 months . RESULTS The mean age of participants was 66.5 ( SD 10.1 ) years . Intervention and control groups did not differ significantly in 6-month change in maximal treadmill walking distance ( average [ SE ] 24.5 [ 19.6 ] meters vs. 39.2 [ 19.6 ] meters ; P = 0.60 ) . Among secondary outcomes , for the intervention and control groups , respectively , average walking speed scores increased by 5.7 [ 2.2 ] units and decreased by 1.9 [ 2.8 ] units ( P = 0.03 ) ; the mental health quality of life subscale score increased by 3.2 [ 1.5 ] and decreased by 2.4 [ 1.5 ] units ( P = 0.01 ) . CONCLUSIONS A home-based walking intervention did not improve walking distance but did improve walking speed and quality of life in people with diabetes and PAD . Clinicians should consider recommending home-based walking therapy for such patients Background This prospect i ve , r and omized , controlled clinical trial compared changes in primary outcome measures of claudication onset time ( COT ) and peak walking time ( PWT ) , and secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle hemoglobin oxygen saturation ( StO2 ) in patients with symptomatic peripheral artery disease ( PAD ) following new exercise training using a step watch ( NEXT Step ) home‐exercise program , a supervised exercise program , and an attention‐control group . Methods and Results One hundred eighty patients were r and omized . The NEXT Step program and the supervised exercise program consisted of intermittent walking to mild‐to‐moderate claudication pain for 12 weeks , whereas the controls performed light resistance training . Change scores for COT ( P<0.001 ) , PWT ( P<0.001 ) , 6‐minute walk distance ( P=0.028 ) , daily average cadence ( P=0.011 ) , time to minimum calf muscle StO2 during exercise ( P=0.025 ) , large‐artery elasticity index ( LAEI ) ( P=0.012 ) , and high‐sensitivity C‐reactive protein ( hsCRP ) ( P=0.041 ) were significantly different among the 3 groups . Both the NEXT Step home program and the supervised exercise program demonstrated a significant increase from baseline in COT , PWT , 6‐minute walk distance , daily average cadence , and time to minimum calf StO2 . Only the NEXT Step home group had improvements from baseline in LAEI , and hsCRP ( P<0.05 ) . Conclusions NEXT Step home exercise utilizing minimal staff supervision has low attrition , high adherence , and is efficacious in improving COT and PWT , as well as secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle StO2 in symptomatic patients with PAD . Clinical Trial Registration URL : Clinical Trials.gov . Unique Identifier : NCT00618670 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 Background We studied whether a 6‐month group‐mediated cognitive behavioral ( GMCB ) intervention for peripheral artery disease ( PAD ) participants , which promoted home‐based walking exercise , improved 6‐minute walk and other outcomes at 12‐month follow‐up , 6 months after completing the intervention , compared to a control group . Methods and Results We r and omized PAD participants to a GMCB intervention or a control group . During phase I ( months 1 to 6 ) , the intervention used group support and self‐regulatory skills during weekly on‐site meetings to help participants adhere to home‐based exercise . The control group received weekly on‐site lectures on topics unrelated to exercise . Primary outcomes were measured at the end of phase I. During phase II ( months 7 to 12 ) , each group received telephone contact . Compared to controls , participants r and omized to the intervention increased their 6‐minute walk distance from baseline to 12‐month follow‐up , ( from 355.4 to 381.9 m in the intervention versus 353.1 to 345.6 m in the control group ; mean difference=+34.1 m ; 95 % confidence interval [CI]=+14.6 , + 53.5 ; P<0.001 ) and their Walking Impairment Question naire ( WIQ ) speed score ( from 36.1 to 46.5 in the intervention group versus 34.9 to 36.5 in the control group ; mean difference = + 8.8 ; 95 % CI=+1.6 , + 16.1 ; P=0.018 ) . Change in the WIQ distance score was not different between the 2 groups at 12‐month follow‐up ( P=0.139 ) . Conclusions A weekly on‐site GMCB intervention that promoted home‐based walking exercise intervention for people with PAD demonstrated continued benefit at 12‐month follow‐up , 6 months after the GMCB intervention was completed . Clinical Trial Registration URL : Clinical Trials.gov . Unique identifier : NCT00693940 Supervised walking exercise is an effective treatment to improve walking ability of patients with peripheral artery disease ( PAD ) , but few exercise programs in community setting s have been effective . The aim of this study was to determine the efficacy of a community-based walking exercise program with training , monitoring and coaching ( TMC ) components to improve exercise performance and patient-reported outcomes in PAD patients . This was a r and omized , controlled trial including PAD patients ( n=25 ) who previously received peripheral endovascular therapy or presented with stable claudic \n Output:\n " }, { "from": "agent", "value": "This meta- analysis suggests that structured home exercise programmes are effective at improving walking performance and physical activity in the short term for patients with PAD" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: INTRODUCTION Contrast-enhanced spectral mammography ( CESM ) may have similar diagnostic performance to Contrast-enhanced MRI ( CEMRI ) in the diagnosis and staging of breast cancer . To date , research has focused exclusively on diagnostic performance when comparing these two techniques . Patient experience is also an important factor when comparing and deciding on which of these modalities is preferable . The aim of this study is to compare patient experience of CESM against CEMRI during preoperative breast cancer staging . METHODS Forty-nine participants who underwent both CESM and CEMRI , as part of a larger trial , completed a Likert question naire about their preference for each modality according to the following criteria : comfort of breast compression , comfort of intravenous ( IV ) contrast injection , anxiety and overall preference . Participants also reported reasons for preferring one modality to the other . Quantitative data were analysed using a Wilcoxon sign-rank test and chi-squared test . Qualitative data are reported descriptively . RESULTS A significantly higher overall preference towards CESM was demonstrated ( n = 49 , P < 0.001 ) , with faster procedure time , greater comfort and lower noise level cited as the commonest reasons . Participants also reported significantly lower rates of anxiety during CESM compared with CEMRI ( n = 36 , P = 0.009 ) . A significantly higher rate of comfort was reported during CEMRI for measures of breast compression ( n = 49 , P = 0.001 ) and the sensation of IV contrast injection ( n = 49 , P = 0.003 ) . CONCLUSION Our data suggest that overall , patients prefer the experience of CESM to CEMRI , adding support for the role of CESM as a possible alternative to CEMRI for breast cancer staging Background Although guidelines recommend that clinicians consider life expectancy before screening older women for breast cancer , many older women with limited life expectancies are screened . We aim ed to identify factors important to mammography screening decisions among women aged 80 and older compared to women aged 65–79 . Methods Telephone surveys of 107 women aged 80 + and 93 women aged 65–79 r and omly selected from one academic primary care practice who were able to communicate in English ( 60 % response rate ) . The survey addressed the following factors in regards to older women 's mammography screening decisions : perceived importance of a history of breast disease , family history of breast cancer , doctor 's recommendations , habit , reassurance , previous experience , mailed reminder cards , family/friend 's recommendations or experience with breast cancer , age , health , and media . The survey also assessed older women 's preferred role in decision making around mammography screening . Results Of the 200 women , 65.5 % were non-Hispanic white and 82.8 % were in good to excellent health . Most ( 81.3 % ) had undergone mammography in the past 2 years . Regardless of age , older women ranked doctor 's recommendations as the most important factor influencing their decision to get screened . Habit and reassurance were the next two highly ranked factors influencing older women to get screened . Among women who did not get screened , women aged 80 and older ranked age and doctor 's counseling as the most influential factors and women aged 65–79 ranked a previous negative experience with mammography as the most important factor . There were no significant differences in preferred role in decision-making around mammography screening by age , however , most women in both age groups preferred to make the final decision on their own ( 46.6 % of women aged 80 + and 50.5 % of women aged 65–79 ) . Conclusion While a doctor 's recommendation is the most important factor influencing elderly women 's mammography screening decisions , habit and reassurance also strongly influence decision-making . Interventions aim ed at improving clinician counseling about mammography , which include discussion s around habit and reassurance , may result in better decision-making BACKGROUND The relative benefits and risks of screening programs for breast cancer have been extensively debated . OBJECTIVES To quantify and investigate heterogeneity in women 's preferences for the benefits and risks of a national breast screening program ( NBSP ) and to underst and the effect of risk communication format on these preferences . METHODS An online discrete choice experiment survey was design ed to elicit preferences from female members of the public for an NBSP described by three attributes ( probability of detecting a cancer , risk of unnecessary follow-up , and out-of-pocket screening costs ) . Survey respondents were r and omized to one of two surveys , presenting risk either as percentages only or as icon arrays and percentages . Respondents were required to choose between two hypothetical NBSPs or no screening in 11 choice sets generated using a Bayesian D-efficient design . The trade-offs women made were analyzed using heteroskedastic conditional logit and scale-adjusted latent class models . RESULTS A total of 1018 women completed the discrete choice experiment ( percentages-only version = 507 ; icon arrays and percentages version = 511 ) . The results of the heteroskedastic conditional logit model suggested that , on average , women were willing-to-accept 1.72 ( confidence interval 1.47 - 1.97 ) additional unnecessary follow-ups and willing-to-pay £ 79.17 ( confidence interval £ 66.98-£91.35 ) for an additional cancer detected per 100 women screened . Latent class analysis indicated substantial heterogeneity in preferences with six latent classes and three scale classes providing the best fit . The risk communication format received was not a predictor of scale class or preference class membership . CONCLUSIONS Most women were willing to trade-off the benefits and risks of screening , but decision makers seeking to improve uptake should consider the disparate needs of women when configuring services IMPORTANCE False-positive mammograms , a common occurrence in breast cancer screening programs , represent a potential screening harm that is currently being evaluated by the US Preventive Services Task Force . OBJECTIVE To measure the effect of false-positive mammograms on quality of life by measuring personal anxiety , health utility , and attitudes toward future screening . DESIGN , SETTING , AND PARTICIPANTS The Digital Mammographic Imaging Screening Trial ( DMIST ) quality -of-life sub study telephone survey was performed shortly after screening and 1 year later at 22 DMIST sites and included r and omly selected DMIST participants with positive and negative mammograms . EXPOSURE Mammogram requiring follow-up testing or referral without a cancer diagnosis . MAIN OUTCOMES AND MEASURES The 6- question short form of the Spielberger State-Trait Anxiety Inventory state scale ( STAI-6 ) and the EuroQol EQ-5D instrument with US scoring . Attitudes toward future screening as measured by women 's self-report of future intention to undergo mammographic screening and willingness to travel and stay overnight to undergo a hypothetical new type of mammography that would identify as many cancers with half the false-positive results . RESULTS Among 1450 eligible women invited to participate , 1226 ( 84.6 % ) were enrolled , with follow-up interviews obtained in 1028 ( 83.8 % ) . Anxiety was significantly higher for women with false-positive mammograms ( STAI-6 , 35.2 vs 32.7 ) , but health utility scores did not differ and there were no significant differences between groups at 1 year . Future screening intentions differed by group ( 25.7 % vs 14.2 % more likely in false-positive vs negative groups ) ; willingness to travel and stay overnight did not ( 9.9 % vs 10.5 % in false-positive vs negative groups ) . Future screening intention was significantly increased among women with false-positive mammograms ( odds ratio , 2.12 ; 95 % CI , 1.54 - 2.93 ) , younger age ( 2.78 ; 1.5 - 5.0 ) , and poorer health ( 1.63 ; 1.09 - 2.43 ) . Women 's anticipated high-level anxiety regarding future false-positive mammograms was associated with willingness to travel overnight ( odds ratio , 1.94 ; 95 % CI , 1.28 - 2.95 ) . CONCLUSIONS AND RELEVANCE False-positive mammograms were associated with increased short-term anxiety but not long-term anxiety , and there was no measurable health utility decrement . False-positive mammograms increased women 's intention to undergo future breast cancer screening and did not increase their stated willingness to travel to avoid a false-positive result . Our finding of time-limited harm after false-positive screening mammograms is relevant for clinicians who counsel women on mammographic screening and for screening guideline development groups To determine if older women with early stage breast cancer have sufficient decisional support during their breast cancer journey , a question naire-based study was conducted at the Sunnybrook Odette Cancer Centre , in Toronto , Ontario , Canada . Women with stages I and II breast cancer , ≥60 years , were contacted upon completion of their adjuvant treatment . A question naire was developed based on focus groups , the literature , and consultation with patients and a multidisciplinary team of experts . The question naire was divided into six domains as follows : ( 1 ) information support surrounding diagnosis , ( 2 ) impact of cancer diagnosis on the patient , ( 3 ) quality of interaction with healthcare team , ( 4 ) decisional support from the healthcare team , ( 5 ) additional information needs surrounding treatment decision , and ( 6 ) information support during radiation treatment . Ninety-two of 137 patients approached were included in the analysis . Ninety percent were > 60 years at the time of diagnosis and 65 % had stage I invasive breast cancer . The majority of women received adequate decisional support during their cancer journey . Approximately 90 % of women indicated that they received a high level of support during their cancer diagnosis . We found no significant differences in overall decisional support based on age at diagnosis , education level , ethnicity , or the presence of co-morbidities . However , participants desired additional educational re sources such as a worksheet , consultation summary , or workbook to assist in making a treatment decision . The majority of participants felt that they had sufficient support while making a treatment decision for breast cancer PURPOSE The aim of this study was to evaluate patient anxiety and its association with perceived radiologist-patient communication in the setting of imaging-guided breast biopsy . METHODS After informed consent was obtained , 138 women recommended for imaging-guided breast procedures completed question naires immediately before and after biopsies , measuring state anxiety using the State-Trait Anxiety Inventory ( range , 20 - 80 ) . Before biopsies , women also completed question naires regarding their perceived communication with the radiologists recommending the procedures ( modified Question naire on the Quality of Physician-Patient Interaction ) , demographic characteristics , and medical history ; immediately after the biopsies , they completed a measure of perceived communication with the radiologists performing the biopsies . Experience levels ( eg , attending radiologist , fellow ) of the radiologists recommending and performing the biopsies were recorded . Data were analyzed using paired and independent t tests , one-way analysis of variance , Pearson 's correlations , and multiple linear regression analyses . RESULTS Average prebiopsy anxiety was 44.5 ± 12.4 ( range , 20 - 77 ) on a scale ranging from 20 to 80 points . Perceived communication with radiologists recommending biopsies averaged 52.4 ± 11.5 ( range , 18 - 65 ) . Better communication with radiologists recommending biopsies was significantly associated with lower levels of prebiopsy anxiety ( r = -0.22 , P = .01 ) . After the biopsies , women 's anxiety significantly decreased ( paired t = -7.32 , P < .001 ) . Better communication with radiologists performing biopsies ( mean , 57.8 ± 8.4 ; range , 32 - 65 ) was associated with lower postbiopsy anxiety after accounting for patients ' baseline anxiety levels ( β = -0.17 , P = .04 ) . White women reported higher prebiopsy and postbiopsy anxiety ; nonwhite women reported poorer communication with recommending radiologists . CONCLUSIONS Patients ' perceptions of better communication with radiologists were associated with lower levels of anxiety before and after biopsies . These results have implication s for radiologist training and adherence to mammographic screening Five community- design ed pilot projects were undertaken to reduce the time to diagnosis following an abnormal mammogram . One thous and five hundred and seventy-eight women with abnormal mammograms completed a self-administered question naire ( 71 % response ) which inquired about experiences and satisfaction with time delay from screening to diagnosis , the information received and support given by health professionals , and measures of anxiety and stress during this time interval . Four of the five pilot project initiatives shortened the time interval from screening to diagnosis , the greatest improvement occurring with facilitated referral from screening to diagnostic breast imaging . There was little difference among the pilot projects and control for most measures of client satisfaction and anxiety . Differences were found between biopsied and nonbiopsied women for several of these measures . Shortening the time to diagnosis positively influenced the client 's perception of unnecessary delay OBJECTIVE The purpose of this study was to assess patient preferences about receiving radiology results and review ing the images and findings directly with a radiologist after completion of an examination . SUBJECTS AND METHODS A prospect i ve survey of English-speaking out patients undergoing either nononcologic CT of the chest , abdomen , and pelvis or nonobstetric ultrasound examinations was completed between December 2010 and June 2011 . Responses to survey items such as preferences regarding communication of results , knowledge of a radiologist , and anxiety level before and after radiologist-patient consultation were recorded . The average wait time between the end of the imaging examination and the consultation and the duration of consultation were documented . RESULTS Eighty-six patients ( 43 men , 4 \n Output:\n " }, { "from": "agent", "value": "Women were willing to accept the psychological and physical burden of breast cancer screening and a significant risk of overdiagnosis and false-positive mammography findings , in return for the benefit of earlier diagnosis .\nThe anxiety engendered by the delay in getting results of diagnostic tests was highlighted as a significant burden , emphasising the need for rapid and efficient screening services , and clear and efficient communication .\nWomen value more the possibility of an earlier diagnosis over the risks of a false-positive result or overdiagnosis .\nConcerns remain that women may not underst and the concept of overdiagnosis .\nWomen highly value time efficient screening processes and rapid result delivery and will accept some discomfort for the peace of mind screening may provide" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To assess the potential benefit of preimplantation aneuploidy testing on the outcome of in vitro fertilization ( IVF ) for women of advanced maternal age ( AMA ) . DESIGN Prospect i ve r and omized clinical trial . SETTING Private IVF clinic . PATIENT(S ) Sixty-two infertile AMA couples undergoing fertility treatment . INTERVENTION(S ) Fluorescent in situ hybridization ( FISH ) for chromosomes X , Y , 13 , 15 , 16 , 17 , 18 , 21 , and 22 . MAIN OUTCOME MEASURE(S ) Preimplantation aneuploidy testing of biopsied blastomeres on day 3 of development . RESULT ( S ) Fertilization and blastocyst developmental rates were similar for the test and control groups : 80 % versus 77.4 % and 49 % versus 48.2 % , respectively . The average number of embryos transferred was comparable at 2.2 for the test group and 2.7 for the control group . Implantation rates were also equivalent across the two groups : 37.3 % in the control group versus 36.5 % in the test group . Nevertheless , the spontaneous abortion rate was observed to be lower for the test group : 25.9 % versus 32.26 % in the control group . This result ed in an observed increase in delivery rates for the test group : 78 % versus 67.74 % in the control group . CONCLUSION ( S ) Preimplantation aneuploidy testing does not appear to statistically significantly improve outcome parameters in infertile AMA patients ; however , a trend toward a decrease in the spontaneous abortion rate with a subsequent higher delivery rate was observed BACKGROUND Single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies in an assisted reproductive technology ( ART ) programme . Besides the morphological quality and embryo kinetics up to the blastocyst stage , preimplantation genetic screening ( PGS ) of aneuploidy has been advocated as an adjuvant approach to select the embryo . METHODS Couples with a female partner younger than 36 were r and omly assigned to undergo transfer of a single blastocyst in a cycle with or without PGS using FISH for the chromosomes X , Y , 13 , 16 , 18 , 21 , 22 . RESULTS After the enrolment of 120 of the projected 447 patients in each group , study recruitment was terminated prematurely on the basis of futility . The observed live birth delivery rates after ART were 30.8 versus 30.8 % per r and omized patient , 34.6 versus 34.6 % per cycle initiated , 37.8 versus 37.0 % per aspirated cycle and 41.6 versus 43.5 % per embryo transfer for the control versus the PGS group , respectively , with absolute between-group differences ( 95 % CI ; P value ) of 0 % ( -11.7 to 11.7 ; P = 1.00 ) , 0 % ( -12.7 to 12.7 ; P = 1.00 ) , -0.8 % ( -14.2 to 12.7 ; P = 0.91 ) and 2.1 % ( -12.7 to 16.7 ; P = 0.79 ) , respectively . Even in this younger age group , only 61 % of the embryos had a normal diploid status . CONCLUSIONS The absence of a beneficial treatment effect in this r and omized clinical trial provides no arguments in favour of PGS to improve live birth delivery rate following single-embryo transfer in women under the age 36 . Clinical Trials.gov : NCT00670059 Meiotic errors during oocyte maturation are considered the major contributors to embryonic aneuploidy and failures in human IVF treatment . Various technologies have been developed to screen polar bodies , blastomeres and trophectoderm cells for chromosomal aberrations . Array-CGH analysis using bacterial artificial chromosome ( BAC ) arrays is widely applied for preimplantation genetic diagnosis ( PGD ) using single cells . Recently , an increase in the pregnancy rate has been demonstrated using array-CGH to evaluate trophectoderm cells . However , in some countries , the analysis of embryonic cells is restricted by law . Therefore , we used BAC array-CGH to assess the impact of polar body analysis on the live birth rate . A disadvantage of polar body aneuploidy screening is the necessity of the analysis of both the first and second polar bodies , result ing in increases in costs for the patient and complex data interpretation . Aneuploidy screening results may sometimes be ambiguous if the first and second polar bodies show reciprocal chromosomal aberrations . To overcome this disadvantage , we tested a strategy involving the pooling of DNA from both polar bodies before DNA amplification . We retrospectively studied 351 patients , of whom 111 underwent polar body array-CGH before embryo transfer . In the group receiving pooled polar body array-CGH ( aCGH ) analysis , 110 embryos were transferred , and 29 babies were born , corresponding to live birth rates of 26.4 % per embryo and 35.7 % per patient . In contrast , in the control group , the IVF treatment was performed without preimplantation genetic screening ( PGS ) . For this group , 403 embryos were transferred , and 60 babies were born , result ing in live birth rates of 14.9 % per embryo and 22.7 % per patient . In conclusion , our data show that in the aCGH group , the use of aneuploidy screening result ed in a significantly higher live birth rate compared with the control group , supporting the benefit of PGS for IVF couples in addition to the suitability and effectiveness of our polar body pooling strategy BACKGROUND It is generally accepted that the age-related increased aneuploidy rate is correlated with reduced implantation and a higher abortion rate . Therefore , advanced maternal age ( AMA ) couples are a good target group to assess the possible benefit of preimplantation genetic diagnosis for aneuploidy screening ( PGD-AS ) on the outcome after assisted reproductive technology ( ART ) . METHODS A prospect i ve r and omized controlled clinical trial ( RCT ) was carried out comparing the outcome after blastocyst transfer combined with PGD-AS using fluorescence in situ hybridization ( FISH ) for the chromosomes X , Y , 13 , 16 , 18 , 21 and 22 in AMA couples ( aged > or = 37 years ) with a control group without PGD-AS . From the 400 ( 200 for PGD-AS and 200 controls ) couples that were allocated to the trial , an oocyte pick-up was performed effectively in 289 cycles ( 148 PGD-AS cycles and 141 control cycles ) . RESULTS Positive serum HCG rates per transfer and per cycle were the same for PGD-AS and controls : 35.8 % ( 19.6 % ) [ % /per embryo transfer ( per cycle ) ] and 32.2 % ( 27.7 % ) , respectively ( NS ) . Significantly fewer embryos were transferred in the PGD-AS group than in the control group ( P<0.001 ) . The implantation rate ( with fetal heart beat ) was 17.1 % in the PGD-AS group versus 11.5 % in the control group ( not significant ; P=0.09 ) . We observed a normal diploid status in 36.8 % of the embryos . CONCLUSIONS This RCT provides no arguments in favour of PGD-AS for improving clinical outcome per initiated cycle in patients with AMA when there are no restrictions in the number of embryos to be transferred STUDY QUESTION Do preimplantation genetic diagnosis ( PGD ) couples experience higher levels of stress during pregnancy and the perinatal period compared with couples who conceive spontaneously ( SC ) or with ICSI ? SUMMARY ANSWER PGD couples did not experience more psychological stress during pregnancy and beyond than ICSI or SC couples . WHAT IS ALREADY KNOWN Previous studies have shown that assisted reproduction technology ( ART ) couples are more prone to pregnancy-related anxieties than SC couples , but display depressed feelings to an equal or lesser extent . However , only one study has focused on a female PGD sample , which may be a more vulnerable group than other ART groups , due to the potentially complex hereditary background , adverse childhood experiences and losses . In that study , PGD women experienced a reduction in state anxiety , and maternal-antenatal attachment did not differ from normative data . Unfortunately , no data exist on pregnancy-related anxiety , depression and parental-antenatal attachment . Valuable information from both parents ( e.g. : couples ) is also lacking . STUDY DESIGN , SIZE , DURATION For this longitudinal prospect i ve study question naire , data from 185 women and 157 men ( 157 couples ) were collected between February 2012 until April 2014 . Data were analysed using multilevel analysis . The couples conceiving after PGD , ICSI or SC were followed from the first trimester of the pregnancy until the third month post-partum . PARTICIPANTS / MATERIAL S , SETTING , METHODS A total of 60 PGD , 58 ICSI and 69 SC couples were initially recruited by various departments of Universitair Ziekenhuis Brussel ( UZ Brussel ) . At each trimester ( T1 : 12 - 14 weeks , T2 : 20 - 22 weeks , T3 : 30 - 32 weeks ) of pregnancy , depression ( EPDS ) , pregnancy-related anxieties ( PRAQ ) and parental-antenatal attachment ( M/PAAS ) were recorded . At T4 ( 3 months post-partum ) , depression ( EPDS ) was assessed again . In the first trimester ( T1 ) broad socio-demographic data and at T4 perinatal health data of both mother and child were recorded . Differences between conception groups over time were analysed using multilevel analyses , taking into account covariation between measurements and within couples . Several perinatal covariates as well as social desirability , coping and adult attachment style were controlled for . MAIN RESULTS AND THE ROLE OF CHANCE All three conception groups had similar scores for depression during pregnancy and beyond . Also , pregnancy-related anxiety scales did not differ among the three groups . All groups also followed a similar trajectory in time regarding their scores for anxiety , depression and parental-antenatal attachment . ART groups did not give more socially desirable answers than SC controls . The subsequent moderators : coping and adult attachment style did not add any relevant information . No interaction effects occurred between gender and conception groups . LIMITATIONS , REASONS FOR CAUTION The participants were Caucasian , Dutch-speaking couples , with medium to high socio-economic status , from a single centre . Our data should be replicated by multicultural and multicentre studies . Furthermore , the inclusion of an additional control group of couples who did not opt for PGD but for prenatal diagnosis may point to the most beneficial strategy for the couple . WIDER IMPLICATION S OF THE FINDINGS PGD parents invest a similar amount of time and emotion in their future children compared with controls . This implies that successful PGD treatment makes an important psychological contribution towards the well-being of couples given their complex hereditary and family background s. STUDY FUNDING /COMPETING INTERESTS This research project was funded by grants from the internal research council of the Vrije Universiteit Brussel ( OZR ) , the Flemish Fonds Wetenschappelijk Onderzoek ( FWO ) and the Wetenschappelijk Fonds Willy Gepts ( WGFG ) . UZ Brussel and the Centre for Medical Genetics have received several educational grants for organizing the data collection , from IBSA , Ferring , Organon , Shering-Plough , Merck and Merck Belgium . M.B. has received consultancy and speaker 's fees from Organon , Serono Symposia and Merck STUDY QUESTION Does embryo biopsy inherent to preimplantation genetic screening ( PGS ) affect neurological , cognitive and behavioural development of 4-year-old children ? SUMMARY ANSWER PGS does not seem to affect neurological , cognitive and behavioural development of 4-year-old singletons ; however , our data suggest that it may be associated with altered neurodevelopment in twins . WHAT IS KNOWN ALREADY Evidence concerning the safety of PGS on neurodevelopmental outcome in offspring is scarce . The present study provides information on neurodevelopmental , cognitive and behavioural outcome of 4-year-old PGS offspring . STUDY DESIGN , SIZE , DURATION A prospect i ve , assessor-blinded follow-up study of children born to women who participated in a multi-centre RCT on the effect of IVF with or without PGS . PARTICIPANTS / MATERIAL S , SETTING , METHODS At 4 years , 49 children ( 31 singletons , 9 sets of twins ) born following IVF with PGS and 64 children ( 42 singletons , 11 sets of twins ) born following IVF without PGS ( controls ) were assessed ( post-natal attrition 18 % ) . Neurological development was evaluated with the st and ardized , age-specific and sensitive neurological examination according to Hempel , result ing in a neurological optimality score ( NOS ) , a fluency score and the rate of adverse neurological outcome . Primary outcome was the fluency score , as fluency of movements is easily reduced by subtle dysfunction of the brain . C \n Output:\n " }, { "from": "agent", "value": "Conclusions Comprehensive chromosome screening-based PGD/S can improve clinical pregnancy and live birth rates without adversely affecting functioning in childhood at least up to age 9 ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Although idiopathic membranous nephropathy ( IMN ) is the most common cause of adult-onset nephrotic syndrome , the management of IMN remains controversial . The aim of this prospect i ve study was to compare the efficacy and drug safety of tacrolimus with that of cyclophosphamide ( CTX ; control group ) in IMN patients receiving corticosteroid therapy . A total of 100 IMN patients with nephrotic syndrome were r and omly assigned to receive a combination of corticosteroid therapy and either CTX or tacrolimus . During a follow-up period of at least 18 months , the remission rate after 2 months in the tacrolimus group was 65.1 % , which was higher than that of the CTX group ( 44.2 % ) ( p = 0.02 ) . The mean time to partial or complete remission was 2.20 months in the tacrolimus group and 3.92 months in the CTX group ( p < 0.001 ) . We also found significantly greater improvements in the serum albumin levels in the tacrolimus group compared with the CTX group at the 2-month ( p = 0.003 ) and 3-month time points ( p = 0.01 ) . The serum creatinine levels remained stable in both groups . Although remission was quicker and more common in the tacrolimus group ( compared with the CTX group ) before 3 months , there was no superiority of tacrolimus after 6 months . Glucose intolerance , urinary tract infections , and pneumonia were the major side effects observed in this study . All of the side effects were mild and controlled , and there were fewer side effects in the tacrolimus group compared with the CTX group , indicating a better treatment tolerance in the tacrolimus group To assess whether chlorambucil or cyclophosphamide may have a better therapeutic index in patients with idiopathic membranous nephropathy , we compared two regimens based on a 6-mo treatment , alternating every other month methylprednisolone with chlorambucil or methylprednisolone with cyclophosphamide . Patients with biopsy-proven membranous nephropathy and with a nephrotic syndrome were r and omized to be given methylprednisolone ( 1 g intravenously for 3 consecutive days followed by oral methylprednisolone , 0.4 mg/kg per d for 27 d ) alternated every other month either with chlorambucil ( 0.2 mg/kg per d for 30 d ) or cyclophosphamide ( 2.5 mg/kg per d for 30 d ) . The whole treatment lasted 6 mo ; 3 mo with corticosteroids and 3 mo with one cytotoxic drug . Among 87 patients followed for at least 1 yr , 36 of 44 ( 82 % ; 95 % confidence interval [ CI ] , 67.3 to 91.8 % ) assigned to methylprednisolone and chlorambucil entered complete or partial remission of the nephrotic syndrome , versus 40 of 43 ( 93 % ; 95 % CI , 80.9 to 98.5 % ) assigned to methylprednisolone and cyclophosphamide ( P = 0.116 ) . Of patients who attained remission of the nephrotic syndrome , 11 of 36 in the chlorambucil group ( 30.5 % ) and 10 of 40 in the cyclophosphamide group ( 25 % ) had a relapse of the nephrotic syndrome between 6 and 30 mo . The reciprocal of plasma creatinine improved in the cohort groups followed for 1 yr for both treatment groups ( P < 0.01 ) and remained unchanged when compared with basal values in the cohort groups followed for 2 and 3 yr . Six patients in the chlorambucil group and two in the cyclophosphamide group did not complete the treatment because of side effects . Four patients in the chlorambucil group but none in the cyclophosphamide group suffered from herpes zoster . One patient per group developed cancer . It is concluded that in nephrotic patients with idiopathic membranous nephropathy both treatments may be effective in favoring remission and in preserving renal function for at least 3 yr BACKGROUND Evidence regarding the optimal dose of tacrolimus ( TAC ) in treatment of idiopathic membranous nephropathy ( IMN ) remains inconclusive . The objective of this study was to evaluate the efficacy and safety of low-dose TAC combined with prednisone for patients with IMN . METHODS We conducted a r and omized prospect i ve cohort study in IMN patients : 28 patients received oral TAC ( target whole blood concentration of 2 - 4 ng/mL ) plus prednisone for 12 months , and 28 patients received prednisone combined with intravenous cyclophosphamide ( CYC ) ( 750 mg/m2 body surface ) once every 4 weeks for 24 weeks . RESULTS Of the 56 patients who completed the 12-month treatment , complete remission ( CR ) occurred in 8 ( 28.6 % ) of the CYC group and 18 ( 64.3 % ) of the TAC group ; partial remission ( PR ) occurred in 10 ( 35.7 % ) of the CYC group and 7 ( 25.0 % ) of the TAC group . The probability of remission ( either CR or PR ) was higher in the TAC group than in the CYC group ( p = 0.0439 , by log-rank test ) . Furthermore , a significantly greater improvement in proteinuria and serum albumin levels was observed in the TAC group compared with the CYC group . Patients treated with TAC can often show a rapid increase in their serum albumin levels before any obvious reduction of urinary protein excretion . Side effects were mild and transitory in both groups . CONCLUSION The results demonstrated that the combined therapy of low-dose TAC and prednisone is an effective and safe therapeutic method for Chinese adults with IMN . Low-dose TAC accompanied by prednisone is enough to induce remission in the majority of patients with IMN BACKGROUND We conducted a pilot trial to compare the effectiveness and safety of 2 different treatments in patients with membranous nephropathy and nephrotic syndrome . METHODS To vali date the hypothesis that the 2 treatments were equivalent , patients with biopsy-proven membranous nephropathy and nephrotic syndrome were r and omly assigned to methylprednisolone alternated with a cytotoxic drug every other month for 6 months ( group A ) or to intramuscular synthetic adrenocorticotropic hormone administered twice a week for 1 year ( group B ) . RESULTS The primary outcome measure is cumulative number of remissions as a first event . Fifteen of 16 patients in group A and 14 of 16 patients in group B entered complete or partial remission as a first event . After a median follow-up of 24 months ( interquartile range , 15 to 25 months ) , there were 4 complete remissions and 8 partial remissions in group A versus 8 complete remissions and 6 partial remissions in group B. Median proteinuria decreased from protein of 5.1 g/d ( interquartile range , 4.0 to 7.3 g/d ) to 2.1 g/d ( interquartile range , 0.4 to 3.8 g/d ; P = 0.004 ) in group A and 6.0 g/d ( interquartile range , 4.4 to 8.5 g/d ) to 0.3 g/d ( interquartile range , 0.2 to 1.9 g/d ; P = 0.049 ) in group B. Two patients from each group interrupted treatment because of side effects or inefficacy . CONCLUSION Most nephrotic patients with membranous nephropathy responded to either treatment . Proteinuria was significantly decreased with both methylprednisolone and cytotoxic agents or prolonged administration of synthetic adrenocorticotropic hormone , without significant differences between these 2 therapies Background Appropriate immunosuppressive therapy for patients with idiopathic membranous nephropathy ( MN ) remains controversial . The effect of mycophenolate mofetil ( MMF ) versus cyclosporine ( CsA ) combined with low-dose corticosteroids was evaluated in patients with idiopathic MN in a multi-center r and omized trial ( NCT01282073 ) . Methods A total of 39 biopsy-proven idiopathic MN patients with severe proteinuria were r and omly assigned to receive MMF combined with low-dose corticosteroids ( MMF group ) versus CsA combined with low-dose corticosteroids ( CsA group ) , respectively , and followed up for 48 weeks . Complete or partial remission rate of proteinuria and estimated glomerular filtration rate ( eGFR ) at 48 weeks were compared . Results The level of proteinuria at baseline and at 48 weeks was 8.9 ± 5.9 and 2.1 ± 3.1 g/day , respectively , in the MMF group compared to 8.4 ± 3.5 and 3.2 ± 5.7 g/day , respectively , in the CsA group . In total , 76.1 % of the MMF group and 66.7 % of the CsA group achieved remission at 48 weeks ( 95 % confidence interval , −0.18 to 0.38 ) . There was no difference in eGFR between the two groups . Anti-phospholipase A2 receptor Ab levels at baseline decreased at 48 weeks in the complete or partial remission group ( P = 0.001 ) , but were unchanged in the no-response group . There were no significant differences between the two groups in changes in the Gastrointestinal Symptom Rating Scale and Gastrointestinal Quality of Life Index scores from baseline to 48 weeks . Conclusion In combination with low-dose corticosteroids , the effect of MMF may not be inferior to that of CsA in patients with idiopathic MN , with similar adverse effects including gastrointestinal symptoms . Trial Registration Clinical Trials.gov Identifier : R and omized trials of rituximab in primary membranous nephropathy ( PMN ) have not been conducted . We undertook a multicenter , r and omized , controlled trial at 31 French hospitals ( NCT01508468 ) . Patients with biopsy-proven PMN and nephrotic syndrome after 6 months of nonimmunosuppressive antiproteinuric treatment ( NIAT ) were r and omly assigned to 6-month therapy with NIAT and 375 mg/m2 intravenous rituximab on days 1 and 8 ( n=37 ) or NIAT alone ( n=38 ) . Median times to last follow-up were 17.0 ( interquartile range , 12.5 - 24.0 ) months and 17.0 ( interquartile range , 13.0 - 23.0 ) months in NIAT-rituximab and NIAT groups , respectively . Primary outcome was a combined end point of complete or partial remission of proteinuria at 6 months . At month 6 , 13 ( 35.1 % ; 95 % confidence interval [ 95 % CI ] , 19.7 to 50.5 ) patients in the NIAT-rituximab group and eight ( 21.1 % ; 95 % CI , 8.1 to 34.0 ) patients in the NIAT group achieved remission ( P=0.21 ) . Rates of antiphospholipase A2 receptor antibody ( anti-PLA2R-Ab ) depletion in NIAT-rituximab and NIAT groups were 14 of 25 ( 56 % ) and one of 23 ( 4.3 % ) patients at month 3 ( P<0.001 ) and 13 of 26 ( 50 % ) and three of 25 ( 12 % ) patients at month 6 ( P=0.004 ) , respectively . Eight serious adverse events occurred in each group . During the observational phase , remission rates before change of assigned treatment were 24 of 37 ( 64.9 % ) and 13 of 38 ( 34.2 % ) patients in NIAT-rituximab and NIAT groups , respectively ( P<0.01 ) . Positive effect of rituximab on proteinuria remission occurred after 6 months . These data suggest that PLA2R-Ab levels are early markers of rituximab effect and that addition of rituximab to NIAT does not affect safety Idiopathic membranous nephropathy is a common cause of nephrotic syndrome whose pathogenesis may involve B-cell functions . Rituximab is a monoclonal antibody that binds to the CD20 antigen on B cells thereby deleting them . We conducted an open-label pilot trial of rituximab treatment in 15 severely nephrotic patients with proteinuria refractory to angiotensin-converting enzyme inhibition and /or receptor blockade but with adequately controlled blood pressure . Rituximab was given 2 weeks apart and , at 6 months , patients who remained proteinuric but had recovered B-cell counts were given a second course of treatment . Proteinuria was significantly decreased by about half at 12 months . Of the 14 patients who completed follow-up , full remission was achieved in two and partial remission in six patients based upon the degree of proteinuria . Side effects were minor ; however , we found no relationship between the response and number of B cells in the blood , CD20 cells in the kidney biopsy , degree of \n Output:\n " }, { "from": "agent", "value": "Thechanges of serum creatinine ( Scr ) was not significantly different between eachtreatments of immunosuppressive agents and the control , except for STE whichhas the possibility of increasing Scr ( SMD , 1.00 ( 95 % CI 0.36 to 1.64)).Comparisons among all treatments of immunosuppressive agents showed nostatistical significance in the outcome of relapse .\nInfection , gastrointestinal symptoms , and bone marrow suppression were the common adverseevents associated with most of the immunosuppressive therapies .\nThis study demonstrates that TAC+TW , TAC and CTX are superior to other immunosuppressive agents in terms of TR and 24 hours UTP .\nMoreover , they are all at risk of infection , gastrointestinal symptoms , and myelosuppression .\nFurthermore , TAC could increase the risk of glucose intolerance or new-onset diabetes mellitus .\nConversely , STE alone , LEF and MZB seem to have little advantage in clinical treatment of IMN ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE : To compare the neurodevelopmental outcome of premature infants treated with recombinant human erythropoietin with that of control infants . STUDY DESIGN : A total of 20 treated infants and 20 control infants who had completed r and omized , double-blind , placebo-controlled studies of recombinant human erythropoietin as treatment for anemia of prematurity were followed for growth and developmental outcome in an intensive care nursery follow-up program . Infants were assessed by st and ard developmental tests . RESULTS : No differences were found between groups for neurologic outcome , cognitive outcome , or growth patterns . All infants treated with recombinant human erythropoietin were neurologically normal . The rate of cognitive deficits was similar in the two groups . CONCLUSION : In this small sample we did not see differences in neurodevelopmental outcome between infants treated with recombinant human erythropoietin and control infants Backgroud : The aim of the study was to evaluate the effect of early parenteral iron supplementation combined erythropoietin for prevention of anemia in preterm infants . Methods : In total , 96 preterm infants were r and omly assigned to 3 groups : a control group receiving st and ard parenteral nutrition ( group 1 : n = 31 ) , an iron-supplemented group ( group 2 : IS , n = 33 ) , and an iron-supplemented combined erythropoietin group ( group 3 : IS+EPO , n = 32 ) . The primary objective was to assess hemoglobin ( Hb ) levels . The secondary objectives included assessment of red blood cell counts ( RBC ) , mean cell volume ( MCV ) , serum iron , ferritin , percentages of reticulocyte ( RET ) , total iron binding capacity ( TIBC ) and oxidative stress , which was assessed by measuring plasma levels of malondialdehyde and superoxide dismutase at baseline and at 2 weeks . The blood routine indices including Hb , RBC , MCV , and percentages of RET were measured at corrected age of 1 and 3 months . Results : At 2 weeks of life , the percentages of reticulocyte in group 2 and group 3 were significantly higher than those in group 1 ( 2.1±0.4 , 2.5±0.3 , and 1.7±0.3 , respectively , P < 0.001 , P<0.001 ) , whereas TIBC were significantly lower than those in group 1 ( 36.7±4.6 , 36.0±4.7 , and 41.6 ± 5.2 respectively , P = 0.011 , P = 0.006 ) . There were no significant differences in RBC counts , the levels of hemoglobin , ferritin , malondialdehyde , and superoxide dismutase among the 3 groups at 2weeks of life . RBC , Hb , MCV , body weight , body length , and head circumference at a corrected age of 1 month did not differ among 3 groups . At corrected age of 3months , more infants in the control group had abnormal Hb and MCV levels ( Hb levels : 114.3 ± 21.3 , 123.7 ± 31.6 , and 125.1 ± 21.2 , P = 0.021 , P = 0.034 , respectively ; MCV : 74.1 ± 3.5 , 78.3 ± 4.7 and 79.1 ± 5.2 , P = 0.017 , P = 0.012 , respectively ) , whereas cases of oral iron , cases of breastfeeding , RBC , body weight , body length , and head circumference were not different among 3 groups . Conclusion : Early parenteral iron supplementation combined erythropoietin in preterm infants improved the percentages of reticulocyte , decreased total iron binding capacity , and improved the Hb and MCV levels at 3 months of age . Early parenteral iron supplementations with EPO were beneficial for the preterm infants In vitro and animal studies suggest that high concentrations of recombinant human erythropoietin ( rHuEPO ) might divert multipotent progenitors into erythroid maturation at the expense of granulocyte production . We determined whether changes of number and lineage commitment of peripheral blood progenitor cells occur in premature infants during therapy with rHuEPO . Thirty preterm infants were r and omly assigned either to receive 300 IU of eopoetin alpha s.c . per kilogram body weight three times a week for four weeks or to a control group . At study entry and after two weeks of treatment the numbers of circulating BFU-E , granulocyte-macrophage colony-forming units ( CFU-GM ) and granulocyte-erythrocyte-macrophage-megakaryocyte CFU ( CFU-GEMM ) were analyzed by semisolid culture technique , CD34 + cells and early myeloid CD34+CD45RA- progenitors by flow cytometry . As compared with the control group , rHuEPO treatment did not exert any significant modulatory effect on numbers of CFU-GM , nor was there a significant change in numbers of BFU-E , CFU-GEMM , total-CFU , percentage of CD34 + or CD34+CD45RA- cells . Mean neutrophil count was not significantly reduced at any period during the study . Compared with the control group , the infants receiving rHuEPO had higher hematocrit values ( p = 0.003 ) and absolute reticulocyte counts ( p < 0.001 ) . The median cumulative volume of blood transfused per kilogram per day was 0.86 ml ( first quartile 0.5 ml ; third quartile 1.1 ml ) in the control group and 0 ml ( first quartile 0 ml ; third quartile 0.47 ml ) in the rHuEPO group ( p = 0.038 ) . We conclude using a relatively high dose of rHuEPO in premature infants , no significant in vivo effect on circulating peripheral blood progenitor or neutrophil count could be detected Despite improved survival , many preterm infants undergo subsequent neurodevelopmental impairment . To date , no neuroprotective therapies have been implemented into clinical practice . Erythropoietin , a haematopoietic cytokine used for treatment of anaemia of prematurity , has been shown to have neuroprotective and neuroregenerative effects on the brain in many experimental studies . The aim of the study was to assess the effect of recombinant human erythropoietin on the microstructural development of the cerebral white matter using tract-based spatial statistics performed at term equivalent age . A r and omized , double-blind placebo-controlled , prospect i ve multicentre study applying recombinant human erythropoietin in the first 42 h after preterm birth entitled ' Does erythropoietin improve outcome in preterm infant ' was conducted in Switzerl and ( NCT00413946 ) . Preterm infants were given recombinant human erythropoietin ( 3000 IU ) or an equivalent volume of placebo ( NaCl 0.9 % ) intravenously before 3 h of age after birth , at 12 - 18 h and at 36 - 42 h after birth . High resolution diffusion tensor imaging was obtained at 3 T in 58 preterm infants with mean ( st and ard deviation ) gestational age at birth 29.75 ( 1.44 ) weeks , and at scanning at 41.1 ( 2.09 ) weeks . Imaging was performed at a single centre . Voxel-wise statistical analysis of the fractional anisotropy data was carried out using tract-based spatial statistics to test for differences in fractional anisotropy between infants treated with recombinant human erythropoietin and placebo using a general linear model , covarying for the gestational age at birth and the corrected gestational age at the time of the scan . Preterm infants treated with recombinant human erythropoietin demonstrated increased fractional anisotropy in the genu and splenium of the corpus callosum , the anterior and posterior limbs of the internal capsule , and the corticospinal tract bilaterally . Mean fractional anisotropy was significantly higher in preterm infants treated with recombinant human erythropoietin than in those treated with placebo ( P < 0.001 ) . We conclude that early recombinant human erythropoietin administration improves white matter development in preterm infants assessed by diffusion tensor imaging and tract-based spatial statistics OBJECTIVE To evaluate the efficacy and safety of enteral recombinant human granulocyte colony-stimulating factor ( rhG-CSF ) and recombinant human erythropoietin ( rhEPO ) in preventing feeding intolerance . STUDY DESIGN An interventional r and omized control trial was conducted in 90 preterm infants born at ≤33 weeks gestational age . The neonates were assigned to 4 groups ; 20 received rhG-CSF , 20 received rhEPO , 20 received both , and 30 received distilled water ( placebo control ) . The test solution was given at the beginning of enteral feeding and was discontinued when enteral intake reached 100 mL/kg/day or after a maximum of 7 days , whichever came first . Feeding tolerance and adverse effects of treatment were assessed . Serum granulocyte colony-stimulating factor and erythropoietin levels were measured on days 0 and 7 of treatment . RESULTS All neonates tolerated the treatment without side effects . Neonates who received rhG-CSF and /or rhEPO had better feeding tolerance , as reflected by earlier achievement of 75 mL/kg/day , 100 mL/kg/day , and full enteral feeding of 150 mL/kg/day with earlier weight gain and a shorter hospital stay ( P < .05 ) . The risk of necrotizing enterocolitis was reduced from 10 % to 0 % in all treatment groups ( P < .05 ) . There was a shorter duration of withholding of feeding secondary to feeding intolerance among neonates receiving both rhG-CSF and rhEPO compared with those receiving placebo ( P < .05 ) . Serum levels of granulocyte colony-stimulating factor and erythropoietin at 0 and 7 days did not differ across the treatment groups . CONCLUSIONS Enteral administration of rhG-CSF and /or rhEPO improves feeding outcome and decreases the risk of necrotizing enterocolitis in preterm neonates . The mechanism may involve the prevention of villous atrophy BACKGROUND : We previously reported decreased transfusions and donor exposures in preterm infants r and omized to Darbepoetin ( Darbe ) or erythropoietin ( Epo ) compared with placebo . As these erythropoiesis-stimulating agents ( ESAs ) have shown promise as neuroprotective agents , we hypothesized improved neurodevelopmental outcomes at 18 to 22 months among infants r and omized to receive ESAs . METHODS : We performed a r and omized , masked , multicenter study comparing Darbe ( 10 μg/kg , 1 × /week subcutaneously ) , Epo ( 400 U/kg , 3 × /week subcutaneously ) , and placebo ( sham dosing 3 × /week ) given through 35 weeks ’ postconceptual age , with transfusions administered according to a st and ardized protocol . Surviving infants were evaluated at 18 to 22 months ’ corrected age using the Bayley Scales of Infant Development III . The primary outcome was composite cognitive score . Assessment s of object permanence , anthropometrics , cerebral palsy , vision , and hearing were performed . RESULTS : Of the original 102 infants ( 946 ± 196 g , 27.7 ± 1.8 weeks ’ gestation ) , 80 ( 29 Epo , 27 Darbe , 24 placebo ) returned for follow-up . The 3 groups were comparable for age at testing , birth weight , and gestational age . After adjustment for gender , analysis of covariance revealed significantly higher cognitive scores among Darbe ( 96.2 ± 7.3 ; mean ± SD ) and Epo recipients ( 97.9 ± 14.3 ) compared with placebo recipients ( 88.7 ± 13.5 ; P = .01 vs ESA recipients ) as was object permanence ( P = .05 ) . No ESA recipients had cerebral palsy , compared with 5 in the placebo group ( P < .001 ) . No differences among groups were found in visual or hearing impairment . CONCLUSIONS : Infants r and omized to receive ESAs had better cognitive outcomes , compared with placebo recipients , at 18 to 22 months . Darbe and Epo may prove beneficial in improving long-term cognitive outcomes of preterm infants ABSTRACT : To assess whether erythropoietin ( EPO ) treatment is safe and reduces the need for transfusion , we r and omized 44 preterm infants to an EPO group and a comparable control ( CON ) group . EPO 150 U/kg was given s.c . twice weekly for 6 wk from the 1st wk of life . Hematologic parameters , transfusion requirements , and growth were followed during therapy and for 6 mo thereafter . To better assess in which neonates EPO treatment was effective , we classified retrospectively the EPO and CON groups into uncomplicated neonates ( EPO A : n = 9 , birth weight = 1247 ± 126 g , gestational age = 29.8 ± 1.5 wk ; CON A : n = 7 , birth weight = 1217 ± 145 g , gestational age = 29.9 ± 1. \n Output:\n " }, { "from": "agent", "value": "The number of RBC transfusions per infant was minimally reduced , but the number of donors to whom infants who were transfused were exposed was not significantly reduced .\nEarly administration of ESAs reduces the use of red blood cell ( RBC ) transfusions , the volume of RBCs transfused , and donor exposure after study entry .\nSmall reductions are likely to be of limited clinical importance .\nThis up date found no significant difference in the rate of ROP ( stage ≥ 3 ) for studies that initiated EPO treatment at less than eight days of age , which has been a topic of concern in earlier versions of this review .\nEarly EPO treatment significantly decreased rates of IVH , PVL , and NEC ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND --Tuberculous pleurisy can result in pleural fibrosis , calcification and thickening . To prevent these complications , corticosteroids are frequently used in addition to antituberculous drugs ; however , new therapeutic regimens can control the disease and minimise the sequelae , and there is no convincing evidence of the benefit of the use of corticosteroids as adjuvant therapy . METHODS -- Patients received isoniazid 5 mg/kg and rifampicin 10 mg/kg daily for six months . Additionally , they were r and omly assigned to a double blind treatment with either prednisone ( 1 mg/kg/day for 15 days and then tapering off ) or placebo during the first month of treatment . Different clinical , radiological , and functional parameters were evaluated to assess the effect of corticosteroids . RESULTS --Fifty seven patients received prednisone and 60 placebo . At the end of the treatment the clinical outcome , the rate of reabsorption of the pleural fluid , the pleural sequelae , as well as lung capacity were similar in both groups . CONCLUSIONS --Corticosteroids do not influence the clinical outcome or the development of long term pleural sequelae in tuberculous pleurisy To determine the effect of adjunct therapy , we carried out a prospect i ve cohort study on 190 patients with tuberculous pleural effusion during May 2003-April 2004 . Patients were divided into 3 groups . All groups were treated with anti-tuberculosis ( TB ) drugs for 6 months ; in group 2 ( n = 46 ) prednisolone , 30 mg/day for 10 days , was added ; group 3 ( n = 78 ) were given paracentesis to remove fluid . Fever and constitutional symptoms disappeared faster in group 2 ( P > 0.05 ) . After 10 days , there was a significantly greater reduction in the size of pleural effusion in group 2 , but after 6 months the difference was not statistically significant . We found corticosteroids and therapeutic paracentesis are not necessary in the management of TB pleural effusion BACKGROUND Active tuberculosis may accelerate progression of human immunodeficiency virus ( HIV ) infection by promoting viral replication in activated lymphocytes . Glucocorticoids are used in pleural tuberculosis to reduce inflammation-induced pathology , and their use also might reduce progression of HIV by suppressing immune activation . We examined the effect that prednisolone has on survival in HIV-1-associated pleural tuberculosis . METHODS We conducted a r and omized , double-blind , placebo-controlled trial of prednisolone as an adjunct to tuberculosis treatment , in adults with HIV-1-associated pleural tuberculosis . The primary outcome was death . Analysis was by intention to treat . RESULTS Of 197 participants , 99 were assigned to the prednisolone group and 98 to the placebo group . The mortality rate was 21 deaths/100 person-years ( pyr ) in the prednisolone group and 25 deaths/100 pyr in the placebo group ( age- , sex- , and initial CD4 + T cell count-adjusted mortality rate ratio , 0.99 [ 95 % confidence interval , 0.62 - 1.56 ] [ P = .95 ] ) . Resolution of tuberculosis was faster in the prednisolone group , but recurrence rates were slightly ( though not significantly ) higher , and use of prednisolone was associated with a significantly higher incidence of Kaposi sarcoma ( 4.2 cases/100 pyr , compared with 0 cases/100 pyr [ P = .02 ] ) . CONCLUSIONS In view of the lack of survival benefit and the increased risk of Kaposi sarcoma , the use of prednisolone in HIV-associated tuberculous pleurisy is not recommended Although several studies on tuberculous ( TB ) pleurisy suggest that the addition of corticosteroids to anti-TB therapy may have beneficial effects , these agents are not used routinely . To assess the effects of short-term oral prednisone therapy in TB pleurisy , 74 patients were r and omly assigned in a double-blind fashion to treatment with either placebo or prednisone at a dose of 0.75 mg/kg/d for up to 4 weeks with gradual reduction over an additional 2 weeks . All subjects received a st and ard 3-drug anti-TB chemotherapy regimen for 6 months . TB pleurisy was diagnosed by histologic study and /or culture of pleural biopsy specimens obtained at thoracoscopy . Complete drainage of the effusion was performed simultaneously . Outcome measures were assessed periodically for 24 weeks , including indexes of morbidity and pleural thickening . After r and omization , four patients were excluded from the final analysis . Of the 70 patients analyzed , 34 received prednisone and 36 received placebo . Demographic and clinical characteristics of the treatment groups were comparable at the time of hospital admission . Although a statistically significant improvement in symptoms occurred earlier in the prednisone group ( 8 weeks ) than in the placebo group ( 12 weeks ) , between-group comparison showed no significant differences at any of the follow-up evaluations . The proportion of subjects in the prednisone group ( 53.1 % ) with residual pleural thickening at 6 months did not differ significantly from that of the placebo group ( 60 % ) . Pleural effusions did not recur in any of the patients . Initial complete drainage of the effusion was associated with greater symptomatic improvement than any subsequent therapy . We conclude that st and ard anti-TB therapy and early complete drainage is adequate for the treatment of TB pleurisy . The addition of short-term oral prednisone therapy neither results in clinical ly relevant earlier symptom relief nor confers a beneficial effect on residual pleural thickening \n Output:\n " }, { "from": "agent", "value": "Compared to the controls ( placebos or non-steroids ) , adjunctive corticosteroid use reduced the risk of residual pleural fluid after 4 weeks and the number of days to symptom improvement ; however , there was no convincing evidence to support the positive effects of corticosteroids over the long term ( 8 weeks ) on residual pleural fluid , pleural thickening , or pleural adhesions , and there was no statistical difference between the corticosteroid group and control group with respect to 7-days relief of the clinical symptoms or death from any cause .\nIn addition , more adverse events were observed in patients who received corticosteroids than in those in the control group .\nOur results suggest that adjunctive corticosteroid use did not improve long-term efficacy and might induce more adverse events , although the risk of residual pleural fluid at 4 weeks and the number of days to symptom improvement were reduced" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The stimulation of insulin vs. inhibition of glucagon secretion in relation to the antidiabetic action of glucagon-like peptide-1 ( GLP-1 ) is not established . Here , the influence of a 4-wk increase in circulating GLP-1 by inhibition of dipeptidyl peptidase-4 ( DPP-4 ) on 24-h glucose and insulin and glucagon responses to breakfast was studied in subjects with dietary controlled diabetes [ age : 65 + /- 8 yr ( SD ) , body mass index : 27.3 + /- 3.3 kg/m(2 ) , fasting plasma glucose : 9.0 + /- 1.3 mmol/liter ] . Compared with placebo ( n = 19 ) , a specific DPP-4 inhibitor [ ( 1-[[(3-hydroxy-1-adamantyl ) amino ] acetyl]-2-cyano-(S)-pyrrolidine ) ( LAF237 ) ; 100 mg daily , n = 18 ] reduced fasting glucose by 0.70 mmol/liter ( P = 0.037 ) , 4-h pr and ial glucose excursion by 1.45 mmol/liter ( P < 0.001 ) , and mean 24-h glucose by 0.93 mmol/liter ( P < 0.001 ) . Baseline and postpr and ial active GLP-1 were increased by LAF237 . The glucagon response to breakfast was reduced by LAF237 ( glucagon levels at 60 min were 88 + /- 8 pg/ml before treatment vs. 77 + /- 5 pg/ml after ; P = 0.001 ) . In contrast , the overall insulin levels were not altered . The 4-wk reduction in glucagon correlated with the reduction in 2-h glucose ( r = 0.61 ; P = 0.008 ) . No such association was observed for insulin . Thus , improved metabolic control by DPP-4 inhibition in type 2 diabetes is seen in association with reduced glucagon levels and , despite the lower glycemia , unaltered insulin levels Introduction Saxagliptin , sitagliptin , and vildagliptin are dipeptidyl peptidase-4 ( DPP-4 ) inhibitors widely approved for use in patients with type 2 diabetes . Using a crossover design , the present study compared trough levels of DPP-4 inhibition provided by these agents in a single cohort of patients with type 2 diabetes . Methods This was a r and omized , placebo-controlled , open-label , five-period crossover study . Eligible patients were 18–65 years of age , either treatment-naïve or off prior antihyperglycemic agent therapy for at least 6 or 12 weeks ( depending on the prior therapy ) , and had glycated hemoglobin ( HbA1C ) ≥6.5 % and ≤10.0 % . In separate study periods , patients received 5 mg saxagliptin q.d . ( saxa-5 ) , 100 mg sitagliptin q.d . ( sita-100 ) , 50 mg vildagliptin q.d . ( vilda-50-q.d . ) , 50 mg vildagliptin b.i.d . ( vilda-50-b.i.d . ) , or placebo for 5 days . The primary endpoint was trough % DPP-4 inhibition , derived by comparing DPP-4 activity 24 h after the Day-5 morning dose with predose activity in the same period and analyzed using a linear mixed-effects model with fixed-effects terms for treatment and period . Results Mean ( range ) baseline HbA1C was 7.4 % ( 6.4–9.0 % ; N = 22 ) . Least-squares ( LS ) mean trough % DPP-4 inhibition was 73.5 % , 91.7 % , 28.9 % , 90.6 % , and 3.5 % after saxa-5 , sita-100 , vilda-50-q.d . , vilda-50-b.i.d . , and placebo , respectively . In patients treated with sita-100 , the LS-mean difference in trough % DPP-4 inhibition was 18.2 % greater than with saxa-5 ( p < 0.001 ) , 62.9 % greater than with vilda-50-q.d . ( p < 0.001 ) , 1.1 % greater than with vilda-50-b.i.d . ( p = 0.128 ) , and 87.8 % greater than with placebo ( p < 0.001 ) . Mean % DPP-4 inhibition was nearly maximal at 12 h postdose regardless of active treatment . Thus , these between-group comparisons at trough primarily reflected differences in duration of action . Adverse events reported during the study were transient and mild or moderate in intensity . Conclusion Once daily treatment with sitagliptin provided trough DPP-4 inhibition significantly greater than saxagliptin or vildagliptin administered once daily , and similar to that provided by vildagliptin administered twice daily Aim : To investigate the safety , tolerability , pharmacokinetics and pharmacodynamics of linagliptin in patients with type 2 diabetes mellitus ( T2DM ) \n Output:\n " }, { "from": "agent", "value": "Our study indicated that DPP-4 inhibitors show greater efficacy in Japanese patients than in non-Japanese patients , which may be an important consideration in the global development strategy of new diabetic medications" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Increasing evidence suggests an important role of carbohydrate quality in the development of type 2 diabetes . OBJECTIVE Our objective was to prospect ively examine the association between glycemic index , glycemic load , and dietary fiber and the risk of type 2 diabetes in a large cohort of young women . DESIGN In 1991 , 91249 women completed a semiquantitative food-frequency question naire that assessed dietary intake . The women were followed for 8 y for the development of incident type 2 diabetes , and dietary information was up date d in 1995 . RESULTS We identified 741 incident cases of confirmed type 2 diabetes during 8 y ( 716 300 person-years ) of follow-up . After adjustment for age , body mass index , family history of diabetes , and other potential confounders , glycemic index was significantly associated with an increased risk of diabetes ( multivariate relative risks for quintiles 1 - 5 , respectively : 1 , 1.15 , 1.07 , 1.27 , and 1.59 ; 95 % CI : 1.21 , 2.10 ; P for trend = 0.001 ) . Conversely , cereal fiber intake was associated with a decreased risk of diabetes ( multivariate relative risks for quintiles 1 - 5 , respectively : 1 , 0.85 , 0.87 , 0.82 , and 0.64 ; 95 % CI : 0.48 , 0.86 ; P for trend = 0.004 ) . Glycemic load was not significantly associated with risk in the overall cohort ( multivariate relative risks for quintiles 1 - 5 , respectively : 1 , 1.31 , 1.20 , 1.14 , and 1.33 ; 95 % CI : 0.92 , 1.91 ; P for trend = 0.21 ) . CONCLUSIONS A diet high in rapidly absorbed carbohydrates and low in cereal fiber is associated with an increased risk of type 2 diabetes Previous studies suggest that a low-glycaemic index ( LGI ) diet may improve insulin sensitivity ( IS ) . As IS has been shown to decrease during refeeding , we hypothesised that an LGI- v. high-GI ( HGI ) diet might have favourable effects during this phase . In a controlled nutritional intervention study , sixteen healthy men ( aged 26·8 ( SD 4·1 ) years , BMI 23·0 ( SD 1·7 ) kg/m2 ) followed 1 week of overfeeding , 3 weeks of energy restriction and of 2 weeks refeeding at ^50 % energy requirement ( 50 % carbohydrates , 35 % fat and 15 % protein ) . During refeeding , subjects were divided into two matched groups receiving either high-fibre LGI or lower-fibre HGI foods ( GI 40 v. 74 , fibre intake 65 ( SD 6 ) v. 27 ( SD 4 ) g/d ) . Body weight was equally regained in both groups with refeeding ( mean regain 70·5 ( SD 28·0)% of loss ) . IS was improved by energy restriction and decreased with refeeding . The decreases in IS were greater in the HGI than in the LGIgroup ( group £ time interactions for insulin , homeostasis model assessment of insulin resistance ( HOMAIR ) , Matsuda IS index (MatsudaISI);all P,0·05 ) . Mean interstitial glucose profiles during the day were also higher in the HGI group ( DAUCHGI-LGI of continuous interstitial glucose monitoring : 6·6 mmol/l per 14 h , P¼0·04 ) . At the end of refeeding , parameters of IS did not differ from baseline values in either diet group ( adiponectin , insulin , HOMAIR , Matsuda ISI , M-value ; all P.0·05 ) . In conclusion , nutritional stress imposed by dietary restriction and refeeding reveals a GI/fibre effect in healthy non-obese subjects . LGI foods rich in fibre may improve glucose metabolism during the vulnerable refeeding phase of a weight cycle BACKGROUND Insulin sensitivity ( Si ) is improved by weight loss and exercise , but the effects of the replacement of saturated fatty acids ( SFAs ) with monounsaturated fatty acids ( MUFAs ) or carbohydrates of high glycemic index ( HGI ) or low glycemic index ( LGI ) are uncertain . OBJECTIVE We conducted a dietary intervention trial to study these effects in participants at risk of developing metabolic syndrome . DESIGN We conducted a 5-center , parallel design , r and omized controlled trial [ RISCK ( Reading , Imperial , Surrey , Cambridge , and Kings ) ] . The primary and secondary outcomes were changes in Si ( measured by using an intravenous glucose tolerance test ) and cardiovascular risk factors . Measurements were made after 4 wk of a high-SFA and HGI ( HS/HGI ) diet and after a 24-wk intervention with HS/HGI ( reference ) , high-MUFA and HGI ( HM/HGI ) , HM and LGI ( HM/LGI ) , low-fat and HGI ( LF/HGI ) , and LF and LGI ( LF/LGI ) diets . RESULTS We analyzed data for 548 of 720 participants who were r and omly assigned to treatment . The median Si was 2.7 × 10(-4 ) mL · μU(-1 ) · min(-1 ) ( interquartile range : 2.0 , 4.2 × 10(-4 ) mL · μU(-1 ) · min(-1 ) ) , and unadjusted mean percentage changes ( 95 % CIs ) after 24 wk treatment ( P = 0.13 ) were as follows : for the HS/HGI group , -4 % ( -12.7 % , 5.3 % ) ; for the HM/HGI group , 2.1 % ( -5.8 % , 10.7 % ) ; for the HM/LGI group , -3.5 % ( -10.6 % , 4.3 % ) ; for the LF/HGI group , -8.6 % ( -15.4 % , -1.1 % ) ; and for the LF/LGI group , 9.9 % ( 2.4 % , 18.0 % ) . Total cholesterol ( TC ) , LDL cholesterol , and apolipoprotein B concentrations decreased with SFA reduction . Decreases in TC and LDL-cholesterol concentrations were greater with LGI . Fat reduction lowered HDL cholesterol and apolipoprotein A1 and B concentrations . CONCLUSIONS This study did not support the hypothesis that isoenergetic replacement of SFAs with MUFAs or carbohydrates has a favorable effect on Si . Lowering GI enhanced reductions in TC and LDL-cholesterol concentrations in subjects , with tentative evidence of improvements in Si in the LF-treatment group . This trial was registered at clinical trials.gov as IS RCT N29111298 OBJECTIVE To examine the relation between weight change and weight fluctuation ( cycling ) and mortality in middle-aged men . METHODS A prospect i ve study of 5608 men aged 40 to 59 years at screening , drawn from one general practice in each of 24 British towns . Changes in weight observed during a 12- to 14-year period were related to mortality during the subsequent 8 years . RESULTS There were 943 deaths from all causes : 458 cardiovascular disease ( CVD ) and 485 non-CVD deaths . Those with stable weight or weight gain had the lowest total , CVD , and non-CVD mortality . Sustained weight loss or weight fluctuation ( loss-gain or gain-loss ) showed a significantly higher mortality risk than stable weight even after adjustment for lifestyle variables ( relative risk [ 95 % confidence interval ] , 1.60 [ 1.32 - 1.95 ] , 1.50 [ 1.17 - 1.91 ] , and 1.63 [ 1.24 - 2.14 ] , respectively ) . Adjustment or exclusion of men with preexisting disease markedly attenuated the increased risk of CVD and total mortality associated with sustained weight loss and weight gain-weight loss . In long-term nonsmokers , any weight loss since screening was associated with an increased risk of mortality , but this was markedly attenuated by adjustment for preexisting disease . Recent ex-smokers showed the most marked increase in mortality associated with sustained weight loss . CONCLUSIONS The increased mortality in middle-aged men with sustained weight loss and weight fluctuation ( cycling ) is determined to a major extent by disadvantageous lifestyle factors and preexisting disease . The evidence suggests that weight loss and weight fluctuation ( cycling ) in these men does not directly increase the risk of death OBJECTIVE Intake of carbohydrates that provide a large glycemic response has been hypothesized to increase the risk of NIDDM , whereas dietary fiber is suspected to reduce incidence . These hypotheses have not been evaluated prospect ively . RESEARCH DESIGN AND METHODS We examined the relationship between diet and risk of NIDDM in a cohort of 42,759 men without NIDDM or cardiovascular disease , who were 40–75 years of age in 1986 . Diet was assessed at baseline by a vali date d semiquantitative food frequency question naire . During 6-years of follow-up , 523 incident cases of NIDDM were documented . RESULTS The dietary glycemic index ( an indicator of carbohydrate 's ability to raise blood glucose levels ) was positively associated with risk of NIDDM after adjustment for age , BMI , smoking , physical activity , family history of diabetes , alcohol consumption , cereal fiber , and total energy intake . Comparing the highest and lowest quintiles , the relative risk ( RR ) of NIDDM was 1.37 ( 95 % CI , 1.02–1.83 , P trend = 0.03 ) . Cereal fiber was inversely associated with risk of NIDDM ( RR = 0.70 ; 95 % CI , 0.51–0.96 , P trend = 0.007 ; for > 8.1 g/day vs. < 3.2 g/day ) . The combination of a high glycemic load and a low cereal fiber intake further increased the risk of NIDDM ( RR = 2.17 , 95 % CI , 1.04–4.54 ) when compared with a low glycemic load and high cereal fiber intake . CONCLUSIONS These findings support the hypothesis that diets with a high glycemic load and a low cereal fiber content increase risk of NIDDM in men . Further , they suggest that grains should be consumed in a minimally refined form to reduce the incidence of NIDDM The risk of coronary heart disease ( CHD ) is influenced by family history , insulin sensitivity ( IS ) , and diet . Adiposity affects CHD and IS . The cellular mechanism of IS is thought to involve the adipocyte cytokine tumor necrosis factor-alpha ( TNF-alpha ) . Insulin-stimulated glucose uptake in isolated subcutaneous and omental adipocytes obtained during elective surgery was measured in 61 premenopausal women , 24 with a parental history ( PH ) of CHD . In vivo IS was measured using the short insulin tolerance test ( SITT ) in 28 women , 16 with PH-CHD , before and 3 weeks after r and omization to a low glycemic index ( LGI ) or high glycemic index ( HGI ) diet . In vitro adipocyte IS and TNF-alpha production was measured following dietary modification . On the habitual diet , in vitro insulin-stimulated glucose uptake in adipocytes as a percentage increase over basal was less in women with PH-CHD than in those without it ( presented as the median with 95 % confidence limits : subcutaneous , 28 % ( 17 % to 39 % ) v 96 % ( 70 % to 120 % ) , P < .01 ) ; omental , 40 % ( 28 % to 52 % ) v 113 % ( 83 % to 143 % ) , P < .01 ) . In vivo IS in 16 PH-CHD subjects and 12 controls before dietary r and omization was similar , and increased in both groups consuming a LGI versus HGI diet ( PH-CHD , 0.31 ( 0.26 to 0.37 ) v 0.14 ( 0.10 to 0.24 ) mmol/L/min , P < .01 ; controls , 0.31 ( 0.1 to 0.53 ) v 0.15 ( 0.06 to 0.23 ) mmol/L/min , P < .05 ) . Adipocyte IS was greater in PH-CHD women on a LGI versus HGI diet ( subcutaneous , 50 % ( 20 % to 98 % ) v 13 % ( 1 % to 29 % ) ; omental , \n Output:\n " }, { "from": "agent", "value": "There is also a Cochrane systematic review which suggests that the GI may play a role in promoting weight loss .\nTherefore , the literature , as it currently st and s , presents a convincing case for the clinical application of the GI in the management of body weight and glucose homeostasis .\nIn this issue of the British Journal of Nutrition , Lagerpusch et al. observed that in the dynamic phase of weight gain , a high-fibre , low-GI diet reduced daytime measurements of interstitial glucose when compared with an energy-matched lowfibre , high-GI diet .\nFurthermore , the deterioration in insulin sensitivity induced by refeeding was attenuated , though the effects of the two dietary interventions were resolved at the end of the refeeding phase .\nThe authors do not offer any suggestions as to which specific dietary manipulation they believe may be driving their observed improvements in glucose metabolism and insulin sensitivity .\nIn two large-scale epidemiological studies ( the Nurses ’ Health Study and Health Professionals Follow-up Study ) , it has been demonstrated that the risk of developing type 2 diabetes increases with a concomitant increase in dietary glycaemic load ( the GI multiplied by the amount of carbohydrate consumed ) and a reduction in fibre consumption .\nThe uncoupling of these two aspects of the diet meant that the relationship disappeared or was significantly weaker .\nFurthermore , the Reading , Imperial , Surrey , Cambridge , and Kings ( RISCK ) study , a large multicentre dietary intervention in over 500 adults at risk of CVD , aim ed to eluci date how dietary changes may influence insulin sensitivity and other CVD risk factors .\nA surprising finding of the study was the absence of an improvement in insulin sensitivity following a lowv .\nhigh-GI diet .\nThis raises the intriguing question of whether the dietary deconstruction seen in most nutritional interventions , in line with the current reductionist scientific approach , is actually detrimental .\nBy controlling for every aspect of the diet , could we actually be missing important physiological effects that occur from dietary manipulations which often go h and -in-h and , like GI and dietary fibre ?\nIn the gastrointestinal tract , low-GI diets with a high fibre content slow gastric emptying , reduce digesta transit rate and alter the luminal environment , all of which will ultimately delay glucose absorption and result in an ameliorated insulin response .\nFor example , high-fibre , low-GI diets may promote insulin sensitivity by improving metabolic flexibility , i.e. the ability of an organism to modify fuel oxidation in response to changes in nutrient availability .\nMetabolic flexibility enables an efficient transition from lipid oxidation and high rates of fatty acid uptake during the fasted state , to suppression of lipid oxidation and increased glucose uptake and utilisation in response to insulin stimulation ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Accumulated evidence shows that biology and the environment can mediate self-injurious behavior ( SIB ) in persons with mental retardation . Whether pharmacological treatment alters the environmental mediation of self-injury is unclear . Opioid antagonist effects on sequential dependencies for self-injury were studied in the context of experimental single-subject double-blind placebo-controlled design s. Direct observational data were collected for 4 adult subjects in real time on daily rate of SIB and staff interactions . Clinical ly significant reductions ( i.e. , > or = 33 % ) in SIB rate were observed for 3 of the 4 subjects . For all subjects , the magnitude of the sequential dependency between staff behavior and self-injury was significantly greater during treatment with naltrexone than during treatment with a placebo . Results are discussed in relation to behavioral mechanisms of action regulating medication effects for self-injury The author describes and emphasizes the value of a symptom and behavior rating checklist for teachers ' use in drug studies with children . Factor analysis of the scale produced five factors that gave reliable subscales over a one-month period . A treatment study of dextroamphetamine with a group of children having learning and /or behavior disorders showed significant changes in all factors compared with a placebo group in a double-blind study BACKGROUND It is hypothesized that self-injurious behavior ( SIB ) and symptoms of autism may be due to overactivity in some opioid systems in the brain . We examined the efficacy and safety of naltrexone hydrochloride , an opioid antagonist , in the treatment of SIB and autism in mentally retarded adults . METHOD Thirty-three mentally retarded adults with autism and /or SIB participated in double-blind , placebo-controlled crossover studies . Active treatment was first a single 100-mg dose of naltrexone hydrochloride . Subsequently , 19 subjects were treated with 50 mg/d and 14 with 150 mg/d of naltrexone hydrochloride for 4 weeks . The outcome was assessed by means of direct observations ( n = 11 ) and on the basis of scores on a list of target behaviors , the Aberrant Behavior Checklist , and the Clinical Global Impression Scale . RESULTS Thirty-two subjects ( seven with autism , 16 with autism and SIB , and nine with SIB ) completed the trial . Naltrexone treatment failed to have therapeutic effects on SIB and autism . On the contrary , naltrexone increased the incidence of stereotypic behavior on the Aberrant Behavior Checklist , and the care staff evaluated the effect of the 50-mg/d treatment as being significantly worse than that of the placebo treatment as measured by the Clinical Global Impression Scale . CONCLUSION Our findings suggest that naltrexone has no clinical value for a broad group of mentally retarded subjects with SIB and /or autism The efficacy of the serotonin ( 5-HT ) uptake inhibitor clomipramine in the treatment of self-injurious behavior ( SIB ) was tested in individuals with severe and profound mental retardation . Six of the 8 subjects who completed a double-blind , placebo-controlled crossover trial exhibited a clinical ly significant improvement ( 50 % or greater reduction from placebo ) in the frequency of SIB . Clomipramine treatment was also associated with improvement in SIB intensity , frequency of stereotypy and compulsions , teacher ratings of stereotypy and social withdrawal , and frequency of staff intervention required for problem behaviors . Adverse effects ( seizure and tachycardia/agitation ) occurred in 2 of the 8 subjects . These results represent the first controlled trial of a 5-HT uptake inhibitor in the treatment of SIB in mental retardation BACKGROUND Self-injurious behaviour ( SIB ) is a serious condition , with implication s for the person , their family and financial costs to the state providing care . The previously reported prevalence of SIB has ranged from 1.7 % to 41 % , or 1.7%-23.7 % in community studies . There has been little study of remission rate , and incidence has not previously been reported . SIB has been reported to be individually associated with lower ability , autism and communication impairments , but given the inter-relationships between these three factors , it is not known whether they are independently associated with SIB . This study investigates the point prevalence , incidence and remission rates of SIB among the adult population with intellectual disabilities ( ID ) , and explores which factors are independently associated with SIB . METHOD A prospect i ve cohort study design was used in a general community setting . The participants were all adults ( 16 years and over ) with ID in a defined geographical area . Individual assessment s were conducted with all participants . RESULTS The point prevalence of SIB ( as defined by DC-LD ) was 4.9 % , the two-year incidence was 0.6 % , and two-year remission rate was 38.2 % . Independently related to SIB were : lower ability level , not living with a family carer , having attention deficit hyperactivity disorder , visual impairment , and not having Down syndrome . Other factors , including communication impairment , autism , and level of deprivation of the area resided within , were not related . CONCLUSIONS SIB is not as enduring and persistent as previously thought ; a significant proportion gains remission in this time period . This should provide hope for families , paid carers and professionals , and reduce therapeutic nihilism . Our study is a first tentative step towards identifying risk-markers for SIB , and developing aetiological hypotheses for subsequent testing . The extent to which SIB may be a relapsing-remitting ( episodic ) condition requires further investigation , so does further hypothesis-based investigation of factors that might be predictive of incidence of , and remission from , SIB This article outlines the initial stages of an ongoing experiment to evaluate the comparative efficacy of two different therapeutic interventions --behaviour modification and gentle teaching -- in the management of challenging behaviour in children who have learning disabilities . Using a workshop approach , parents are taught the principles and practice of one of these two interventions to enable better management of their child 's challenging behaviour . A range of intervention outcomes are then compared with those of a control group . Preliminary analysis of data has been conducted on information gathered from those parents ( n = 24 ) who attended the gentle teaching workshop only . The results indicate that brief intervention training in gentle teaching can have a positive impact upon the challenging behaviour of the child That 's it , a book to wait for in this month . Even you have wanted for long time for releasing this book rating scales and assessment instruments for use in pediatric psychopharmacology research ; you may not be able to get in some stress . Should you go around and seek fro the book until you really get it ? Are you sure ? Are you that free ? This condition will force you to always end up to get a book . But now , we are coming to give you excellent solution Several recent reports have indicated that opioid blockers are effective in attenuating self-injurious behavior ( SIB ) . In the present study , four patients with SIB were challenged with four fixed doses ( 0 , 25 , 50 , 100 mg ) of naltrexone . In a double-blind procedure , all patients received each dose on a different week as determined by latin square design . Naltrexone was given on Monday and Wednesday of each week , and patients were videotaped daily for 10 minutes in the morning and afternoon . The tapes were scored for incidents of SIB , stereotypy , and activity , with interrater reliability of 0.93 . The Conners Teacher Rating Scale was administered by staff in the morning and afternoon each day . The Vinel and was completed each week ( Thursday ) . All patients had decreased SIB when treated with naltrexone . Three patients decreased their SIB as dose of naltrexone increased . There were no consistent effects of naltrexone on stereotypy , activity , or performance on the Conners or the Vinel and . These results suggest that endogenous opioids are implicated in SIB and that naltrexone is a powerful tool for examination of this treatment-resistant behavior The opioid antagonist naltrexone was administered to 8 adults with severe or profound mental retardation and extensive histories of self-injurious behavior . Five-minute behavioral sample s were observed r and omly out of every hour from 8 a.m. through 3 p.m. , Monday through Friday , for four 2-week phases ( baseline , placebo , 50 mg , and 100 mg ) . During naltrexone administration , there were fewer days with frequent head-banging and self-biting , whereas there were more days on which blows to the head or self-biting were infrequent . Self-injurious participants slept 1.38 hours less per night during baseline , which was unaffected by naltrexone \n Output:\n " }, { "from": "agent", "value": "Due to sparse data , an absence of power and statistical significance , and high risk of bias for four of the included trials , we are unable to reach any definite conclusions about the relative benefits of naltrexone or clomipramine compared to placebo" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The aim of this study was to assess symptoms and health-related quality of life ( HRQL ) during (neo)adjuvant radiotherapy for rectal cancer . Patients receiving pelvic radiotherapy 50 Gy for rectal cancer , were studied prospect ively ( n=42 ) . The European Organization for Research and Treatment of Cancer ( EORTC ) question naires quality of life-core 30 QLQ-C30 and QLQ-CR38 and a 5-day symptom diary were completed at the start and end of radiotherapy and 4 - 6 weeks later . At the end of radiotherapy , mean scores of diarrhoea , fatigue and appetite loss had significantly increased ( P<0.01 ) compared with pretreatment scores , but this was not observed for scores for nausea or pain . At the end of radiotherapy , diarrhoea , fatigue , appetite loss , physical function , social function and global quality of life ( QL ) were significantly worse than the population -based norms . 64 % of the patients reported an increase in fatigue and 52 % an increase in diarrhoea during radiotherapy . HRQL scores had returned to pre-treatment levels 4 - 6 weeks after radiotherapy . Thus , diarrhoea , fatigue and appetite loss increased transiently during pelvic radiotherapy Abstract Objective : To compare chemotherapy given at home with outpatient treatment in terms of colorectal cancer patients ' safety , compliance , use of health services , quality of life , and satisfaction with treatment . Design : R and omised controlled trial . Setting : Large teaching hospital . Participants : 87 patients receiving adjuvant or palliative chemotherapy for colorectal cancer . Interventions : Treatment with fluorouracil ( with or without folinic acid or levamisole ) at outpatient clinic or at home . Main outcome measures : Treatment toxicity ; patients ' compliance with treatment , quality of life , satisfaction with care , and use of health re sources . Results : 42 patients were treated at outpatient clinic and 45 at home . The two groups were balanced in terms of age , sex , site of cancer , and disease stage . Treatment related toxicity was similar in the two groups ( difference 7 % ( 95 % confidence interval −12 % to 26 % ) ) , but there were more voluntary withdrawals from treatment in the outpatient group than in the home group ( 14 % v 2 % , difference 12 % ( 1 % to 24 % ) ) . There were no differences between groups in terms of quality of life scores during and after treatment . Levels of patient satisfaction were higher in the home treatment group , specifically with regard to information received and nursing care . There were no significant differences in use of health services . Conclusions : Home chemotherapy seemed an acceptable and safe alternative to hospital treatment for patients with colorectal cancer that may improve compliance and satisfaction with treatment . What is already known on this topic Home chemotherapy programmes have been proposed as an alternative to hospital treatment However , they are more costly , and there is little evidence on their impact on outcomes such as compliance , quality of life , or use of other health services What this study adds Home chemotherapy was not associated with an increased use of health services such as primary care or emergency departments Home chemotherapy had no effect on patients ' quality of life but increased their compliance with treatment and satisfaction , particularly with regard to nursing care Home chemotherapy seems an acceptable and safe alternative to outpatient treatment that may improve compliance with The aims of our study were to assess the effect of follow-up on the quality of life of colorectal cancer patients and to assess the attitudes of patients towards follow-up as a function of patient characteristics . Patients who had been treated with curative intent were selected from four types of hospitals . Eighty-two patients were interviewed using a structured question naire , whereas 130 patients received the question naire by mail . To assess the effect of follow-up on the quality of life , the interviewed patients were r and omly allocated to three groups and interviewed at different times in relation to the follow-up visit . Analysis did not show an effect of the follow-up visit on quality of life . Patients reported a positive attitude towards follow-up : it reassured them , they judged the communication with the physician to be positive , and they experienced only slight nervous anticipation and few other disadvantages . Patients reported a strong preference for follow-up , and a large majority would prefer follow-up even if it would not lead to earlier detection of a recurrence . Apart from living situation , no patient characteristics were clearly associated with the attitude towards follow-up . Implication s for clinical practice are discussed BACKGROUND Heterogeneous results for research investigating health-related quality of life ( HRQL ) in patients undergoing sphincter-ablating procedures for rectal cancer are likely due to single institution experiences and measurement of HRQL . To address this heterogeneity , we evaluated HRQL in patients with rectal cancer by type of surgery , location of tumor , and receipt of adjuvant therapy using an HRQL instrument that has not been used to address rectal cancer patients in a population -based sample over time . METHODS The Functional Assessment of Cancer Therapy-Colorectal instrument was administered at 9 and 19 months after diagnosis to a consecutive sample of 160 patients in Northern California identified by the California Cancer Registry . A broad multidimensional interpretation of HRQL was used to examine the impact of tumor location and treatment status , stage of disease , age , and gender . RESULTS In general , men had lower social well-being scores , and younger patients had lower physical and emotional well-being scores and colorectal concerns scores . We found no differences in HRQL by either tumor location or type of surgery , at either 9 or 19 months after diagnosis . Lower physical well-being and greater adverse colorectal concerns were reported at 9 months among patients who received adjuvant therapy ; however , only adverse colorectal concerns persisted over time . CONCLUSIONS This study provides additional evidence that sphincter-ablating procedures do not necessarily reduce quality of life in patients with rectal cancer . Distinctive features of this study include a broad multidimensional interpretation of HRQL , the 19 months of longitudinal follow-up , and a prospect i ve population -based study design Objective : The purpose of this study was to define the association between pretreatment health-related quality of life ( HRQL ) and surgical complications for patients with colorectal cancer . Summary Background Data : For patients with colorectal cancer , surgical complications arise from an interaction between underlying medical comorbidity , colorectal cancer severity , and quality and type of treatment provided . Measurement of HRQL provides a summarization of well-being in the context of medical comorbidity and colorectal cancer severity . The summarization of these factors may be useful in prospect i ve risk assessment of patients about to undergo surgery for colorectal cancer . Methods : A single-institution , prospect i ve , cohort study of patients with colorectal adenocarcinoma was performed from August 1 , 1999 , to March 31 , 2002 . Before treatment , all participants completed Medical Outcomes Survey SF-36 ( SF-36 ) ; after the first year of the study , patients also completed the colorectal cancer module of the Functional Assessment of Cancer Therapy survey ( FACT-C ) . Information was collected on demographics , treatment , tumor variables , and complications . Results : Ninety-seven patients have undergone open resection of their colorectal cancer . All patients completed SF-36 ; 65 completed FACT-C. Thirty patients ( 31 % ) experienced complications , including 4 ( 4 % ) deaths . Age , race , albumin level , American Society of Anesthesia class , specialty surgical training , tumor location , and stage were not associated with complications in univariate analysis . Patients experiencing surgical complications had significantly lower HRQL scores on SF-36 Social Functioning , General Health Perception , and Mental Health Index scales as well as the Mental Health Component summary score . FACT-C Social/Family , Emotional , Functional Well-Being scores , and the Colorectal Cancer Concerns score were also significantly lower for patients sustaining complications . When these HRQL scales were examined in a multivariate model including albumin level , tumor location , and ASA class , SF-36 Social Functioning ( Odds Ratio [ OR ] = 0.98 ; 95 % Confidence Interval [ CI ] = 0.97–0.99 ) and FACT-C Colorectal Cancer Concerns ( OR = 0.89 ; 95 % CI = 0.79–0.99 ) scales retained a significant association with complications . Conclusions : Pretreatment HRQL scores as measured by several scales of SF-36 and FACT-C were significantly associated with complications . Future studies should concentrate on defining the predictive role of HRQL in determining surgical outcome for patients with colorectal cancer Background The relationship between colorectal cancer ( CRC ) risk and physical activity and dietary habits has been well-established , but less is known about the relationship between these behaviours and quality of life ( QOL ) post-diagnosis . Moreover , it is unknown whether this relationship is consistent across cancer stage or treatment setting . Thus , the purpose of this study was to assess current diet and physical activity behaviour in CRC survivors receiving systemic chemotherapy , and to examine potential associations between these behaviours and quality of life . A secondary purpose was to examine the association between social support , diet , and physical activity behaviour in this population . Methods Using a cross-sectional survey , 67 CRC survivors currently receiving chemotherapy in Calgary , Alberta completed the survey package . Measures included demographic and medical data , physical activity levels , diet behaviour , QOL , and social support . Results In a largely metastatic sample ( 63 % ) , approximately half were meeting national dietary guidelines ( 58 % ) , less were meeting national physical activity guidelines ( 26 % ) , and a small number were meeting both ( 17 % ) . However , only 12.3 % ( n = 8) reported completely sedentary behaviour , and 7 of these 8 participants were receiving metastatic treatment . Neither behaviour was significantly associated with QOL or perceived social support . Furthermore , there were no significant QOL differences between those treated with palliative intent or adjuvant therapy . Important group differences emerged between those meeting and not meeting the guidelines , and associations between QOL , age , BMI , and provisions of social support . Conclusion These findings provide insight into lifestyle behaviours of CRC survivors currently receiving systemic chemotherapy , and the differences in perceived QOL as affected by severity of disease and treatment setting . Prospect i ve studies in a larger sample of CRC survivors on chemotherapy are needed to confirm lifestyle behaviour patterns and identify factors related to QOL that are unique to this population , especially during metastatic treatment Effects of variations in agent , dose , and route of treatment administration on patient reported quality of life ( QOL ) were examined for 279 patients enrolled on a seven-arm r and omized clinical trial ( S8905 ) of 5-FU and its modulation for advanced colorectal cancer . Patients completed QOL question naires at r and omization and weeks 6 , 11 , and 21 post-r and omization with five QOL endpoints considered primary : three treatment-specific symptoms ( stomatitis , diarrhea , and h and /foot sensitivity ) ; physical functioning ; and emotional functioning . Patient compliance with the QOL assessment schedule was good , supporting the feasibility of including QOL measures in cooperative group trials . However , death and deteriorating health produced substantial missing data . Cross-sectional analyses indicated that the seven therapeutic arms did not differ in their impact on QOL . Unfortunately , longitudinal analyses of the QOL data were inappropriate given non-r and om missing data . Graphical presentation of non-r and om missing data identified the seriousness of this problem and its effect on potential conclusions about QOL during treatment . This problem appears to be particularly challenging in the context of advanced-stage disease . Failure to recognize the presence of non-r and om missing data can lead to serious overestimates of patient QOL over time The aim of the study was to evaluate the effects of the use of progressive muscle relaxation training ( PMRT ) on anxiety and quality of life in colorectal cancer patients after stoma surgery . A r and omised controlled trial was used with repeated measures assessment over 10 weeks post-stoma surgery . Fifty-nine patients participated in the study and were r and omised to a control group receiving routine care ( n=30 ) and an experimental group receiving routine care and PMRT through two teaching sessions and practice at home for the first 10 weeks . The State-Trait Anxiety Inventory and two Quality of Life Scales were used to collect the data of interest in three occasions , namely during hospitalisation , at week 5 and at week 10 post-surgery . The use of PMRT significantly decreased state anxiety and improved generic quality of life in the experimental group ( P<0.05 ) , especially in the domains of physical health , psychological health , social concerns and environment . Social relationships decreased in both groups . In relation to the disease-specific quality of life measure , differences were observed only in the 10-week assessment , with the experimental group reporting better quality of life at 10 weeks , but not over time as compared to the control group . The use of PMRT should be incorporated in the long-term care of colorectal cancer patients , as it can improve their psychological health and quality of life . This may be a cost-effective intervention that needs minimal training and could easily be offered to those patients that they would like to use it as part of the specialist care provided to stoma patients PURPOSE AND BACKGROUND We examined whether patients with colon cancer undergoing surgery with or without adjuvant chemotherapy change the internal st and ards on which they base their quality -of-life ( QL ) estimation , and , if they do so , whether this reframing alters interpretation of QL findings . These questions were addressed within a r and omized clinical trial of the Swiss Group for Clinical Cancer Research ( SAKK 40/93 ) . PATIENTS AND METHODS After radical resection of adenocarcinoma of the colon ( pT1 - 4pN > 0M0 and pT3 - 4pN0M0 ) and perioperative chemotherapy , \n Output:\n " }, { "from": "agent", "value": "The findings indicated that patients with colorectal cancer continue to suffer from depression , distress and bowel related problems such as constipation and diarrhoea which impacted their quality of life .\nEuropean Organisation for Research and Treatment of Cancer ( EORTC ) Quality of Life Question naire , Core Module ( QLQ-C30 ) , European Organisation for Research and Treatment of Cancer ( EORTC ) Colorectal Cancer-Specific Quality of Life Question naire Module ( QLQ-CR38 ) and Short Form 36 were the commonly used instruments to assess QoL in this review and most of the instruments included psychological , physical , social and functional aspects .\nYounger colorectal cancer patients had poorer quality of life when compared to elderly patients .\nColorectal cancer also had a greater impact on quality of life outcomes in women when compared to men .\nPsychosocial factors have a great impact on patients ' perceived quality of life ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: With the growing number of patients surviving cancer , there has been an increasing concern with their long-term adaptation . Given the large number of Hodgkin 's disease survivors , it was possible to conduct a study of their psychosocial adaptation . Two hundred seventy-three survivors of advanced Hodgkin 's disease were interviewed over the telephone concerning the impact of cancer upon their lives , in terms of their psychological , social , and sexual functioning . The level of psychological distress was elevated by one st and ard deviation above normal on the Brief Symptom Inventory ( BSI ) , for both men and women . Survivors in greater distress reported more problems in other areas of functioning , including sexual , social , vocational , and persistent conditioned nausea We evaluated 4 different health‐related quality of life ( HRQL ) measures prospect ively to determine their ability to detect change over time : the Health Utilities Index Mark 2 and Mark 3 , the Pediatric Quality of Life Inventory ( PedsQL ) 4.0 Generic Core and Cancer Module , the EuroQol EQ‐5D visual analogue scale ( EuroQol ) , and the Lansky Play‐Performance Scale PURPOSE To evaluate late psychosocial sequelae in long-term survivors of Hodgkin 's disease ( HD ) in the population of Calvados , France . PATIENTS AND METHODS Ninety-three patients issued from the Calvados General Tumor Registry , treated from 1978 to 1990 , free of relapse and second malignancy since January 1991 , were enrolled onto cross-sectional case-control study . One hundred eighty-six healthy controls , matched for sex , age , and residency , were selected at r and om from electoral rolls . Two self-administered question naires were mailed in the spring of 1995 . RESULTS Compared with controls , HD patients reported ( 1 ) more physical ( P < .001 ) , role ( P < .001 ) , and cognitive ( P = .015 ) functioning impairments , as well as dyspnea ( P < .001 ) and chronic fatigue ( P = .025 ) , while no statistical difference was found in global health status ; ( 2 ) to be more often childless ( P = .04 ) , fewer divorces or separations ( P = .013 ) , fewer changes in relationships with friends ( P = .012 ) , similar proportions at work but less ambitious professional plans ( P < .001 ) , and greater difficulties in borrowing from banks ( P < .001 ) ; ( 3 ) a slight increase in the number of visits to a general practitioner ( P = .05 ) and greater consumption of medical re sources ( mainly thyroid extracts , P = .05 ) . CONCLUSION The study demonstrated that French long-term HD survivors have good global health status and good psychologic , familial , and professional status , although difficulties in borrowing from banks remain a major limitation in daily life . Although physical , role , and cognitive functioning impairments persist that might limit their activities , HD survivors seem to have learned to cope with problems related to their disease and its treatment BACKGROUND Little is known about the longitudinal course of health-related quality of life ( HRQoL ) in patients with Hodgkin 's lymphoma during their post-treatment follow-up and re-adaptation to normal life . We report on the HRQoL of patients treated in the r and omised H8 trial of the European Organisation for Research and Treatment of Cancer ( EORTC ) Lymphoma Group and the Groupe d'Etudes des Lymphomes de l'Adulte ( GELA ) . We aim ed to assess HRQoL and fatigue following treatment , to analyse relations with treatment , and to identify factors that predict persistent fatigue . METHODS Patients received HRQoL question naires at the end of primary therapy and during follow-up . The EORTC QLQ-C30 was used to assess HRQoL , and the Multidimensional Fatigue Inventory ( MFI-20 ) was used to assess fatigue . Changes of mean HRQoL scores over time were analysed with mixed models . Multiple polytomic nominal logistic regression was done to identify independent baseline predictors of fatigue within MFI-20 dimensions . Analyses were done on an intention-to-treat basis . This study is registered with www . Clinical Trials.gov , number NCT00379041 . FINDINGS 2666 assessment s from 935 patients were analysed . Mean follow-up was 90 months ( range 52 - 118 ) . Age affected all functioning and symptom scores except emotional functioning , with younger age associated with higher functioning and lower severity of symptoms ; improvement with time showed similar patterns between age groups . Women reported lower HRQoL and higher symptom scores than did men . Overall , 3.2 % ( 14/439 for role functioning ) to 9.7 % ( 43/442 for social functioning ) and 5.8 % ( 29/498 for reduced motivation ) to 9.9 % ( 49/498 for general fatigue ) of patients reported impairments of 10 points or more ( on a 0 - 100 scale ) in QLQ-C30 and MFI-20 scores , respectively , independent of age and sex . Emotional domains were more affected than physical ones . There was no relation between HRQoL outcome and type of treatment . Fatigue ( MFI-20 scores ) at the end of treatment was the only predictive variable for persistent fatigue , with odds ratios varying from 2.58 ( 95 % CI 1.00 - 6.67 ) to 41.51 ( 12.02 - 143.33 ; p</=0.0001 ) . Sensitivity analyses adjusting for missing data were much the same as the main results . INTERPRETATION HRQoL data after treatment for early-stage Hodgkin 's lymphoma show that patients experience strain and limitations in all subdomains apart from cognitive functioning ( QLQ-C30 ) , and also have reduced motivation ( MFI-20 ) . Differences in HRQoL improvement with time were linked to age and sex , but not type of treatment . Fatigue status at the end of treatment seems to predict subsequent HRQoL. FUNDING French Ministry of Health , Programme Hospitalier de Recherche Clinique 1994 , and French National League Against Cancer The objective of this study was to evaluate the health-related quality of life ( HRQOL ) of lymphoma survivors , to compare it with that of the general population , and to identify its predictors in lymphoma survivors . We enrolled 837 participants ( mean age , 54.6 years ; mean time since diagnosis , 6.3 years ) with a history of Hodgkin ’s lymphoma ( HL ) ( n = 58 ) or non-Hodgkin ’s lymphoma ( NHL ) ( n = 779 ) who had been treated at any of three Korean hospitals from 1989 through 2010 . For controls , we selected 1,000 subjects r and omly from a representative Korean population . We administered the European Organization for Research and Treatment of Cancer Quality of Life Question naire Core 30 and the Hospital Anxiety and Depression Scale . Overall , the HRQOL in both groups of survivors and the general population were comparable , but we observed clinical ly meaningful worse social functioning in NHL survivors ( p < 0.001 ) and more severe fatigue in HL survivors ( p < 0.001 ) than in the general population . Analysis of covariance revealed no clinical ly meaningful difference in HRQOL associated with age or sex . Survivors who received peripheral blood stem cell transplants showed clinical ly meaningful worse role ( p = 0.001 ) and social ( p < 0.001 ) functioning than those who were treated with first-line chemotherapy alone . In multivariate analyses , fatigue , depression , and financial difficulties emerged as the strongest predictors for almost all subscales of functioning and global quality of life . Interventions for alleviating fatigue , depression , and financial difficulties are needed to enhance the HRQOL of Korean lymphoma survivors PURPOSE We describe the short and intermediate-term quality -of-life ( QOL ) outcomes in patients treated on a r and omized clinical trial in early-stage Hodgkin 's disease ( Southwest Oncology Group [ SWOG ] 9133 ) comparing subtotal lymphoid irradiation ( STLI ) with combined-modality treatment ( CMT ) . PATIENTS AND METHODS Two hundred forty-seven patients participated in the QOL study ( SWOG 9208 ) , completing several st and ardized instruments ( Symptom Distress Scale ; Cancer Rehabilitation Evaluation System - Short Form ; Medical Outcomes Study 36-Item Short-Form Health Survey Vitality Scale ; and a health perception item ) , as well as questions about work , marital status , and concerns about having children . This article reports on results from baseline before r and om assignment , at 6 months , and at 1 and 2 years after r and om assignment . RESULTS Patients receiving CMT experienced significantly greater symptom distress ( P = .0001 ) , [ corrected ] fatigue ( P = .0001 ) , [ corrected ] and poorer QOL ( P = .015 ) at 6 months than the STLI patients , reflecting a shorter time since completion of therapy in the CMT arm . Importantly , patients in the two groups did not differ on any outcomes at the 1- and 2-year assessment s. The study cohort at r and omization exhibited more fatigue [ corrected ] than healthy reference population s. Fatigue levels did not exceed baseline estimates by the end of the study . [ corrected ] . CONCLUSION This study demonstrated that patients with early-stage Hodgkin 's disease experience a short-term decrease in QOL and an increase in symptoms and fatigue with treatment , which is more severe with CMT ; by 1 year , however , CMT and STLI patients report similar outcomes . Fatigue scores for both arms were lower at baseline than scores for the general population and did not return to normal levels 2 years after r and om assignment . The mechanisms responsible for this lingering problem warrant further investigation BACKGROUND AND METHODS MOPP ( mechlorethamine , vincristine , procarbazine , and prednisone ) has been the st and ard treatment for Hodgkin 's disease for almost 20 years . In a r and omized , multicenter trial , we compared three regimens of primary systemic therapy for newly diagnosed advanced Hodgkin 's disease in Stages IIIA2 , IIIB , and IVA or IVB : ( 1 ) MOPP alone given for 6 to 8 cycles , ( 2 ) MOPP alternating with ABVD ( doxorubicin , bleomycin , vinblastine , and dacarbazine ) for 12 cycles , and ( 3 ) ABVD alone for 6 to 8 cycles . Patients in a first relapse after radiation therapy were eligible . No additional radiation therapy was given . Patients who did not have a complete response or who had a relapse with either MOPP alone or ABVD alone were switched to the opposite regimen . RESULTS Of 361 eligible patients , 123 received MOPP , 123 received MOPP alternating with ABVD , and 115 received ABVD alone . The patients were stratified according to age , stage , previous radiation , histologic features , and performance status . The overall response rate was 93 percent , with complete responses in 77 percent : 67 percent in the MOPP group , 82 percent in the ABVD group , and 83 percent in the MOPP-ABVD group ( P = 0.006 for the comparison of MOPP with the other two regimens , both of which contained doxorubicin ) . The rates of failure-free survival at five years were 50 percent for MOPP , 61 percent for ABVD , and 65 percent for MOPP-ABVD . Age , stage ( III vs. IV ) , and regimen influenced failure-free survival significantly . Overall survival at five years was 66 percent for MOPP , 73 percent for ABVD , and 75 percent for MOPP-ABVD ( P = 0.28 for the comparison of MOPP with the doxorubicin regimens ) . MOPP had more severe toxic effects on bone marrow than ABVD and was associated with greater reductions in the prescribed dose . CONCLUSIONS In this trial , ABVD therapy for 6 to 8 months was as effective as 12 months of MOPP alternating with ABVD , and both were superior to MOPP alone in the treatment of advanced Hodgkin 's disease . ABVD was less myelotoxic than MOPP or ABVD alternating with MOPP In this study health-related quality of life ( HRQL ) in long-term survivors of Hodgkin 's lymphoma ( HL ) was evaluated and the findings were analyzed using a conceptual model developed by Wilson and Cleary . A better underst and ing of the relationships between the variables explaining HRQL may improve care and rehabilitation of HL patients . The population s were long-term survivors of HL ( n=121 ) and a control group ( n = 236 ) . Participants were approached with one semi-structured interview , an extended version of the Schedule for the Evaluation of Individual Quality of Life – Direct Weighting ( SEIQoL-DW ) and three st and ardized question naires : Hospital Anxiety and Depression ( HAD ) scale , Short Form 12 health survey question naire ( SF-12 ) and Sense of Coherence ( SOC ) scale . No differences regarding the mean scores were found between the HL survivors and the controls except for the SF-12 , where the patients considered themselves to be in poorer physical health than the controls ( p < 0.01 ) . Even though physical health was diminished , patients did not \n Output:\n " }, { "from": "agent", "value": "Emphasis on HRQL following therapy may inform initial treatment decisions and long-term survivorship goals ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To compare patterns of uterine activity from low-dose oxytocin begun immediately or six hours after intracervical placement of prostagl and in E2 ( PGE2 ) gel for the induction of labor . STUDY DESIGN A total of 50 nonlaboring women at term with an unfavorable cervix ( Bishop score < or = 4 ) were given a 0.5-mg dose of PGE2 gel . Each was then r and omized either to be observed or to receive a low dose of oxytocin ( 2 mU/min , increased by 2 mU/min at 30-minute intervals , as necessary ) . After the six-hour observation , the patient was reexamined , and a low dose of oxytocin was either begun or continued . An adequate sample size ( 21 per group ) was calculated for evaluating uterine activity changes . Comparisons were made using chi 2 testing , Student 's t test and analysis of variance , as appropriate . RESULTS There were no differences between the two groups in maternal race , gestational age , predose Bishop score , predose uterine activity or indication for induction . Uterine contractions became more frequent ( P < .01 ) and were judged to be more intense ( P < .02 ) and earlier when oxytocin was used immediately after PGE2 placement . No uterine hyperstimulation or abnormal fetal heart rate pattern was observed that required discontinuation of the oxytocin . The percentages of cases delivering vaginally within 24 , 36 and 48 hours were greater when oxytocin was begun immediately in nullipara ( P < .01 ) . CONCLUSION Low-dose oxytocin may be started immediately after instilling intracervical PGE2 , with shortened time until the onset of adequate contractions A r and omized double-blind trial was conducted over 48 hours comparing the effectiveness of prostagl and in E2 gel administered intracervically with that of demoxytocin buccal tablets for induction of labor in 103 patients with unripe cervical status ( Bishop score 5 or less ) . A statistically significant difference was found in success frequency between the two groups , both on the first day ( 54.7 and 34.0 % , respectively ) and on the second day ( 82.0 and 61.9 % , respectively ; P < .05 ) . Without being matched , variables influencing the course of labor in the two groups were comparable . There was no statistically significant difference in the induction-delivery interval between the two groups during the first and second days of the trial . In both the prostagl and in E2 and the demoxytocin groups , patients who had not gone into labor during the first day showed a statistically significant increment in the Bishop score on the morning of the second day ( 2.4 and 1.3 , respectively ; P < .01 ) . The frequency of instrumental deliveries and cesarean section was the same in both groups ; neither hypertonic uterine contractions nor side effects were observed in any patient . It is concluded that prostagl and in E2 gel administered intracervically is particularly well suited for the induction of labor in patients with unripe cervical status because of its combined contraction-inducing and cervical-ripening properties Fifty-two women undergoing labor induction and vaginal delivery at term were r and omized between two oxytocin infusion protocol s , involving hourly versus quarter-hourly increases in dose . Potential differences were sought for duration of labor , amount of uterine activity generated , and amount of oxytocin required . Starting at 0.5 mU/minute , oxytocin infusion was increased regularly in small increments every hour or every 15 minutes , according to group assignment . No differences were observed in potentially confounding clinical and demographic factors between the groups , including time to ruptured membranes . There were no clinical ly or statistically significant differences found for the duration of any phase or stage of labor , quantitative assessment of uterine activity , incidence of hyperstimulation , or neonatal outcome . The average dose of oxytocin used was lower in the hourly than in the quarter-hourly protocol ( 4.4 versus 6.7 mU/minute ; P<.005 ) . Significantly fewer patients on the hourly protocol required a maximum infusion rate exceeding 8 mU/minute ( P<.05 ) . More patients on the hourly protocol either had oxytocin discontinued completely or were maintained at 4 mU/minute or less during the active phase of labor ( P<.05 and P<.001 , respectively ) . We conclude that a slower rate of increase in oxytocin administration via continuous infusion results in no prolongation of any phase of induced labor , while permitting lower infusion rates of the drug One hundred thirty-four indigent patients at term who had premature rupture of membranes and a cervix unfavorable for induction of labor ( 80 % effacement or less , 2 cm dilation or less ) were r and omized to compare expectant with intervention management . Women with any medical or obstetric condition warranting immediate intervention were excluded from the study . Patients treated expectantly were placed at bed rest and observed for labor or infection . Patients managed by intervention were given oxytocin if labor did not ensue within 12 hours of rupture of the membranes . Patients in the intervention protocol had longer labor ( P<.02 ) and a higher incidence of both cesarean delivery ( P<.05 ) and intraamniotic infection ( P<.05 ) . There was only one case of proven neonatal sepsis , and this occurred in a patient managed by induction of labor . There was no statistically significant difference between groups in mean length of maternal hospitalization THE best way to administer oxytocin for the induction of labour is a matter of dispute . In spite of criticism because of high dosages and unknown rates of absorption the buccal route has its proponents ( Chalmers , Ng and Moorhouse , 1966 ) . Oxytocin is also easily absorbed through the nasal mucosa , and in 1962 Borglin introduced grade d polyethylene tubes through which the patient could blow the solution into the nostril . This method of administration appeared to reduce the risks of overdosage by employing fairly low doses , given at short intervals . In Rorglin ’s ( 1962 ) first report the results of the nasal courses were comparable to those of the intravenous drip . The effectiveness of nasal oxytocin for the induction of labour has been confirmed by others ( Ovlisen , 1965 ; Miiller and Osler , 1967 ) . The latter authors compared intravenous , nasal and buccaI administration in consecutive series of 100 patients each , and found a slightly lower success rate for the nasal than for the two other methods . Complications were few and harmless . In our department buccal oxytocin has been the method of choice for a number of years . As the new nasal administration might offer some advantages , and as no r and omized series had been presented previously , a clinical trial was design ed to compare the two methods . The results of a pilot study , in which we utilized the sequential method , were presented in a preliminary communication ( Bergsjo and Jenssen , 1969 ) , which concluded that there was no difference between the effectiveness of the two methods . However , the possibility of not discovering a true difference by the sequential approach is fairly high ( Bross , 1952 ) . In the present report the number of patients has been increased , and a more appropriate statistical method has been employed in the evaluation of the results A clinical trial was carried out to compare the efficacy and tolerance of two modes of induction of labour : vaginally administered prostagl and in E2 gel vs intravenous perfusion of synthetic oxytocin . Fifty women with pregnancy at or near term in whom prompt vaginal delivery was clinical ly indicated were divided at r and om into sub-groups of 25 each . Initial dose of PGE2 gel was 1 mg followed by another application of 1 mg or 2 mg 6 hours later in case active labour stage has not been reached . Progressive oxytocin perfusion began with 1 mU/min . , being increased gradually every 20 minutes until efficacious uterine dynamics were attained . Data were recorded on entry of age , parity , gestation age , cervical dilatation , Bishop score , indication for induction . Continuous materno-foetal monitoring was carried out during the induction period . Results were evaluated from induction/delivery time , type of delivery , maternal and foetal condition , and any side-effects which developed . Apart from a higher number of instrumental deliveries in the PGE2 gel series , which was not related to the induction method , there was no significant difference between any of the variables evaluated , both methods producing active labour in approximately 70 % of the patients within 12 hours . The authors stress , however , the convenience , both for patients and hospital staff , of the administration of an intravaginal induction agent over a systemic therapeutic method of induction Summary : We performed a prospect i ve r and omized study to compare maternal and fetal outcomes in pregnancies with prelabour rupture of the membranes ( PROM ) at term with early induction of labour or expectant management , 126 women with singleton pregnancy , cephalic presentation and gestational duration > 37 weeks , were r and omized either to immediate induction of labour with oxytocin ( Group 1 ) ( n= 52 ) , or conservative management ( Group 2 ) ( n=74 ) . Women who constituted Group 2 were divided into 2 groups . The first group ( Group 2A ) ( n=25 ) included women in whom spontaneous labour did not begin after a waiting period of 24 hours , in which case labour was induced with oxytocin i.e. expectant management . The second group consisted of women ( Group 2B ) ( n=49 ) in whom labour began spontaneously within 24 hours . The base Caesarean section rate was significantly higher in Group 2 ( 28.4 % ) ( p<0.05 ) . The rates of Caesarean section in the Groups 1–2A‐2B were 19.2 % , 60 % , and 12.2 % , respectively for nulliparous and parous women together . The rate of fetal distress was significantly higher in Group 2 ( p<0.05 ) . For determining maternal outcomes , the other parameters such as clinical chorioamnionitis , fever before or during labour , receiving antibiotics before or during labour , postpartum fever , analgesia , anaesthesia did not differ in Groups 1 and 2 . Women in Group 1 went into active labour sooner , had fewer digital vaginal examinations , had a shorter interval between membrane rapture and delivery , and spent less time in the hospital before delivery than those in Group 2 ( p<0.05 ) . Babies in Group 2 were more likely to receive antibiotics , and more likely to stay in an intensive care nursery for more than 24 hours , and more likely to receive ventilation after initial resuscitation than those babies in Group 1 . For developing apnoea and hypotonia , there was no significant difference between Groups 1 and 2 . However , for babies in Group 2A there was a significant difference . We conclude that immediate induction of labour with oxytocin does not increase the risk of Caesarean section , compared with a practice of expectant management . Women at term with prelabour rupture of the membranes should therefore be reassured that immediate induction with oxytocin currently appears to be the best policy with respect to maternal and neonatal morbidity Labor characteristics after intracervical application of 0.5 mg prostagl and in ( PG ) E2 gel ( n = 83 ) versus intravenous administration of oxytocin ( n = 82 ) for labor induction were investigated in uncomplicated prolonged pregnancies with unripe cervix . The induction to delivery time as well as the total oxytocin dose were significantly reduced in the PGE2 group ( p < 0.001 ) . Cesarean sections , instrumental deliveries and fetal distress had the same frequency , but the failures of trial were significantly higher in the oxytocin group than in the PGE2 group ( 20.7 vs. 6 % , p < 0.01 ) . Twenty-four percent of women needed a second PGE2 dose , and almost half of the women in the PGE2 group experienced ' spontaneous ' labor . More neonates in the oxytocin group had 5-min Apgar scores < 7 ( p < 0.05 ) . Intracervical PGE2 gel application is superior to intravenous oxytocin in terms of shortening the induction-delivery interval and increasing the frequency of successful vaginal delivery . In addition , it is safe for mother and fetus Premature rupture of the membranes ( PROM ) in otherwise uncomplicated full-term single pregnancies was studied in a prospect i ve r and omized study . Ninety-three women were r and omized to either induction with oxytocin infusion ( n = 43 ) or expectant management ( n = 50 ) . Twenty-four and 26 respectively were nulliparas . In the induction group , all but 3 were delivered within 24 h from PROM . There were 3 vacuum extraction s ( VE ) , all in nulliparous women . No cesarean section ( CS ) was performed . In the expectancy group , 23 of 50 were delivered within 24 h. There were 5 VE and 3 CS in nulliparas and 1 VE and 1 CS in paras . The instrumental actions were mainly due to arrest of 1st or 2nd stage labor . The only clinical infections occurred in nulliparas in the expectancy group . Our conclusion is that parous women with PROM can be treated by either induction or expectancy while in nulliparas , induction after some hours ' expectation seems preferable Ninety-one pregnant women with unfavourable cervix ( Bishop score no higher than 6 ) were r and omly allocated to induction of labour with either prostagl and in E2 suppositories 2.5 mg 1 - 2 a day or i.v . oxytocin 4 - 32 mU/min . The induction procedure was carried on for 2 days . For statistical comparison of efficacy , life table \n Output:\n " }, { "from": "agent", "value": "Comparison of oxytocin with either intravaginal or intracervical PGE2 reveals that the prostagl and in agents probably increase the chances of achieving vaginal birth within 24 hours .\nOxytocin induction may increase the rate of interventions in labour ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Characterising responders to neoadjuvant chemotherapy ( NAC ) is important to minimise overtreatment and the unnecessary delay of definitive treatment of urothelial urinary bladder cancer . OBJECTIVE To assess the effect of NAC on tumour downstaging and overall survival . DESIGN , SETTING , AND PARTICIPANTS A total of 449 patients from the r and omised prospect i ve Nordic Cystectomy Trials 1 and 2 were analysed retrospectively . Eligible patients were defined as T2-T4aNXM0 preoperatively and pT0-pT4aN0-N+M0 postoperatively . The median follow-up time was 5 yr . INTERVENTION The experimental arm consisted of cisplatin-based NAC ; the control arm consisted of cystectomy only . MEASUREMENTS The primary outcome was tumour downstaging defined as pathologic TNM less than clinical TNM . Different downstaging thresholds were applied : complete downstaging ( CD ) ( pT0N0 ) , noninvasive downstaging ( NID ) ( pT0/pTis/pTaN0 ) , and organ confinement ( OC ) ( ≤ pT3aN0 ) . Downstaging rates and nodal status were compared between the study arms using the chi-square test . Secondary outcome was overall survival ( OS ) stratified by treatment arm , downstaging categories , and clinical stages , analysed by the Kaplan-Meier method . The following covariates were tested as prognostic factors in univariate and multivariate analyses using the Cox regression method : age , sex , clinical stage , pN status , NAC , CD , NID , and OC . RESULTS AND LIMITATIONS Downstaging rates increased significantly in the NAC arm independent of the downstaging threshold . The impact was more prominent in clinical T3 tumours , with a near threefold increase in CD tumours . The combination of CD and NAC showed an absolute risk reduction of 31.1 % in OS at 5 yr compared with CD controls . The combination of NAC and CD revealed a hazard ratio of 0.32 compared with 1.0 for the combination of no NAC and no CD . Limitations were the retrospective approach and uncertain clinical TNM staging . CONCLUSIONS Survival benefits of NAC are reflected in downstaging of the primary tumour . Chemo-induced downstaging might be a potential surrogate marker for OS Background Increasing evidence suggests that cancer-associated inflammation is associated with poorer outcomes . The neutrophil-to-lymphocyte ratio ( NLR ) , considered as a systemic inflammation marker , is thought to predict prognoses in colorectal cancer . In this study , we explored the association between the NLR and prognoses following neoadjuvant chemoradiotherapy ( CRT ) for locally advanced rectal cancer ( LARC ) . Material / Methods From February 2002 to December 2012 , a group of 202 patients diagnosed with LARC and receiving neoadjuvant CRT followed by radical surgery was included in our retrospective study . The associations between the pre-CRT NLR and clinicopathological characteristics , as well as the predictive value of pre-CRT NLR against survival outcomes , were analyzed . Results The average NLR was 2.7±1.5 ( median 2.4 , range 0.6–12.8 ) . There were 63 ( 31.2 % ) patients with NLR ≥3.0 , and 139 ( 68.8 % ) patients with NLR < 3.0 . Correlation analyses showed that no clinicopathological characteristics except age were associated with NLR . We did not find an association between NLR and survival outcomes . In multivariate Cox model analyses , the R1/R2 resection , lymph node ratio ≥0.1 , and perineural/lymphovascular invasion were independently associated with worse disease-free survival and overall survival . Conclusions In our cohort , the NLR did not correlate with survival outcomes in LARC patients undergoing neoadjuvant CRT . The prognostic value of NLR should be vali date d in large-scale prospect i ve studies Background : The ability of pretreatment laboratory markers of acute-phase inflammatory reactions like serum albumin level ( SAL ) , hemoglobin ( Hb ) , and absolute blood cell counts to predict complete pathological response ( CPR ) to neoadjuvant chemoradiotherapy ( NACRT ) in patients with locally advanced rectal cancer ( LARC ) has not yet been fully studied . Methods : We retrospectively examined the relation between SAL , Hb and absolute blood cell counts , and CPR rates in 140 LARC patients treated with NACRT . Results : Univariate analysis showed a significantly higher probability of CPR to NACRT in patients with clinical stage ( CS ) III LARC who had SAL > 3.5 mg/dl ( OR = 2.39 ; p = 0.04 ) and a neutrophil-to-lymphocyte ratio ( NLR ) value < 5 ( OR = 2.86 ; p = 0.03 ) . The relation of CPR with SAL ( OR = 2.11 ; p = 0.048 ) and NLR ( OR = 2.54 ; p = 0.04 ) was confirmed by multivariate analysis in the same subset of patients . None of the parameters studied predicted CPR in patients with CS II disease . Patients who achieved CPR to NACRT had a higher probability of 5-year overall survival ( HR 0.48 ; p = 0.01 ) and 5-year disease-free survival ( HR 0.33 ; p = 0.003 ) . Conclusions : Our data indicate that SAL > 3.5 mg/dl and NLR < 5 may be positively related to CPR after NACRT in patients with CS III LARC . Hypoalbuminemia and a high NLR may be considered an indication for a more aggressive approach to NACRT and postoperative adjuvant chemotherapy in this subset of patients . This hypothesis requires confirmation in a r and omized study Background : Inflammation contributes to the pathogenesis of colorectal cancer ( CRC ) , and cytokine levels are altered during colorectal carcinogenesis . Methods : The serum levels of 13 cytokines and their relation to clinical and pathological parameters , and systemic inflammatory response ( mGPS , CRP and neutrophil – lymphocyte ratio ) , were analysed from a prospect i ve series of 148 CRC patients and 86 healthy age- and sex-matched controls . Results : CRC patients had higher serum platelet-derived growth factor , interleukin (IL)-6 , IL-7 , and IL-8 levels and lower monocyte chemotactic protein-1 ( MCP-1 ) levels than the controls . A logistic regression model for discriminating the patients from the controls – including the five most predictive cytokines ( high IL-8 , high IL-6 , low MCP-1 , low IL-1ra , and low IP-10 ) – yielded an area under curve value of 0.890 in receiver operating characteristics analysis . Serum cytokines showed distinct correlation with other markers of systemic inflammatory response , and advanced CRCs were associated with higher levels of IL-8 , IL-1ra , and IL-6 . A metastasised disease was accompanied by an orientation towards Th2 cytokine milieu . Conclusion : CRC is associated with extensive alterations in serum cytokine environment , highlighting the importance of study ing relative cytokine level alterations . Serum cytokine profile shows promise in separating CRC patients from healthy controls but its clinical value is yet to be confirmed Summary Background Observational studies report reduced colorectal cancer in regular aspirin consumers . R and omised controlled trials have shown reduced risk of adenomas but none have employed prevention of colorectal cancer as a primary endpoint . The CAPP2 trial aim ed to investigate the antineoplastic effects of aspirin and a resistant starch in carriers of Lynch syndrome , the major form of hereditary colorectal cancer ; we now report long-term follow-up of participants r and omly assigned to aspirin or placebo . Methods In the CAPP2 r and omised trial , carriers of Lynch syndrome were r and omly assigned in a two-by-two factorial design to 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo , for up to 4 years . R and omisation was in blocks of 16 with provision for optional single-agent r and omisation and extended postintervention double-blind follow-up ; participants and investigators were masked to treatment allocation . The primary endpoint was development of colorectal cancer . Analysis was by intention to treat and per protocol . This trial is registered , IS RCT N59521990 . Results 861 participants were r and omly assigned to aspirin or aspirin placebo . At a mean follow-up of 55·7 months , 48 participants had developed 53 primary colorectal cancers ( 18 of 427 r and omly assigned to aspirin , 30 of 434 to aspirin placebo ) . Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio ( HR ) of 0·63 ( 95 % CI 0·35–1·13 , p=0·12 ) . Poisson regression taking account of multiple primary events gave an incidence rate ratio ( IRR ) of 0·56 ( 95 % CI 0·32–0·99 , p=0·05 ) . For participants completing 2 years of intervention ( 258 aspirin , 250 aspirin placebo ) , per- protocol analysis yielded an HR of 0·41 ( 0·19–0·86 , p=0·02 ) and an IRR of 0·37 ( 0·18–0·78 , p=0·008 ) . No data for adverse events were available postintervention ; during the intervention , adverse events did not differ between aspirin and placebo groups . Interpretation 600 mg aspirin per day for a mean of 25 months substantially reduced cancer incidence after 55·7 months in carriers of hereditary colorectal cancer . Further studies are needed to establish the optimum dose and duration of aspirin treatment . Funding European Union ; Cancer Research UK ; Bayer Corporation ; National Starch and Chemical Co ; UK Medical Research Council ; Newcastle Hospitals trustees ; Cancer Council of Victoria Australia ; THRIPP South Africa ; The Finnish Cancer Foundation ; SIAK Switzerl and ; Bayer Pharma National Surgical Adjuvant Breast and Bowel Project ( NSABP ) Protocol B-18 was initiated in 1988 to determine whether four cycles of doxorubicin/cyclophosphamide given preoperatively improve survival and disease-free survival ( DFS ) when compared with the same chemotherapy given postoperatively . Secondary aims included the evaluation of preoperative chemotherapy in downstaging the primary breast tumor and involved axillary lymph nodes , the comparison of lumpectomy rates and rates of ipsilateral breast tumor recurrence ( IBTR ) in the two treatment groups , and the assessment of the correlation between primary tumor response and outcome . Initially published findings were based on a follow-up of 5 years ; this report up date s results through 9 years of follow-up . There continue to be no statistically significant overall differences in survival or DFS between the two treatment groups . Survival at 9 years is 70 % in the postoperative group and 69 % in the preoperative group ( P = .80 ) . DFS is 53 % in postoperative patients and 55 % in preoperative patients ( P = .50 ) . A statistically significant correlation persists between primary tumor response and outcome , and this correlation has become statistically stronger with longer follow-up . Patients assigned to preoperative chemotherapy received notably more lumpectomies than postoperative patients , especially among patients with tumors greater than 5 cm at study entry . Although the rate of IBTR was slightly higher in the preoperative group ( 10.7 % versus 7.6 % ) , this difference was not statistically significant . Marginally statistically significant treatment-by-age interactions appear to be emerging for survival and DFS , suggesting that younger patients may benefit from preoperative therapy , whereas the reverse may be true for older patients Abstract Background The neutrophil/lymphocyte ratio ( NLR ) has been reportedly associated with prognosis in cancer patients by influencing both cancer progression and chemosensitivity . However , the correlation between NLR and the outcome of neoadjuvant chemotherapy ( NAC ) in breast cancer patients remains unclear . Methods NLR was evaluated in 177 patients with breast cancer treated with NAC with 5-fluorouracil , epirubicin , and cyclophosphamide , followed by weekly paclitaxel and subsequent curative surgery . The correlation between NLR and prognosis , including the efficacy of NAC , was evaluated retrospectively . Results NLR ranged from 0.5 to 10.6 . Fifty-eight patients with low NLR ( < 3.0 ) had a higher pathological complete response ( pCR ) rate ( p < 0.001 ) and were more frequently diagnosed with ER-negative/progesterone receptor (PR)-negative/HER2-negative ( triple-negative ) breast cancer ( TNBC ; p < 0.001 ) compared with patients with high NLR ( ≥3.0 ) . Among TNBC patients who achieved pCR , disease-free survival ( p = 0.006 ) and overall survival ( p < 0.001 ) were significantly longer in patients with low NLR than in those with high NLR . Low NLR was associated with a significantly favorable prognosis in TNBC patients who achieved pCR , according to univariate analysis ( p = 0.044 , hazard ratio = 0.06 ) . Conclusions Low NLR may indicate high efficacy and favorable outcome after NAC in patients with TNBC Background In \n Output:\n " }, { "from": "agent", "value": "Conclusion : Overall , an NLR lower than the cut-off value indicated a greater chance for pCR and may predict good survival outcomes after NAC for patients with solid tumours ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The efficacy of post-percutaneous coronary intervention ( PCI ) intracoronary injection with bone marrow mesenchymal stem cells ( BMSCs ) in patients with acute myocardial infa rct ion ( AMI ) remains controversial . Here , 58 patients with AMI undergoing PCI were r and omly divided into two groups : BMSC and control groups . Autologous BSMCs were then generated in vitro from the BMSC patients . After transplantation , left ventricular ejection fraction ( LVEF ) , left ventricular end-diastolic dimensions ( LVDd ) , and infa rct size ( IS ) were evaluated in both groups . LVEF , LVDd , and IS improved after BMSC transplantation but the changes were not significantly different from those in the controls . The number of adverse events and rehospitalization rates after 1 month were significantly higher in the control group than in the BMSC group . BMSC transplantation thus benefits patients by decreasing the number of adverse events and reducing the rehospitalization rate in the early stages following PCI BACKGROUND Fractional flow reserve ( FFR ) measured on catheterization is now widely used for the diagnosis of functional myocardial ischemia in patients with coronary artery disease ( CAD ) . FFR , however , is invasive and carries potential procedural complications . Therefore , the aim of this study was to compare the diagnostic capability in functionally significant stenosis identified on FFR , between cardiac magnetic resonance myocardial perfusion imaging ( CMR-MPI ) , single-photon emission computed tomography MPI ( SPECT-MPI ) , and dobutamine stress echocardiography ( DSE ) in patients with CAD . METHODS AND RESULTS A total of 25 patients who had at least 1 angiographic stenosis ≥50 % on coronary angiography was studied . CMR-MPI , SPECT-MPI and DSE were done before FFR measurement . FFR was measured in all 3 major epicardial coronary arteries . Out of 71 vascular territories excluding 4 territories due to inadequate imaging , 29 ( 41 % ) had FFR < 0.80 . The sensitivity of CMR-MPI was significantly higher than that of SPECT-MPI and DSE ( P=0.02 and P=0.001 , respectively ) . The area under the receiver operating characteristic curve ( AUC ) for CMR-MPI ( AUC , 0.92 ) was significantly greater than for SPECT-MPI ( AUC , 0.73 ; P=0.006 ) and DSE ( AUC , 0.69 ; P<0.001 ) . CONCLUSIONS CMR-MPI performed well in the detection of functionally significant stenosis defined according to FFR , and had the highest diagnostic sensitivity among the 3 modalities tested in patients with CAD Rationale : Mesenchymal precursor cells ( MPCs ) are a specific Stro-3 + sub population of mesenchymal stem cells isolated from bone marrow . MPCs exert extensive cardioprotective effects , and are considered to be immune privileged . Objective : This study assessed the safety , feasibility , and efficacy of intracoronary delivery of allogeneic MPCs directly after acute myocardial infa rct ion in sheep . Methods and Results : Initially , intracoronary delivery conditions were optimized in 20 sheep . These conditions were applied in a r and omized study of 68 sheep with an anterior acute myocardial infa rct ion . Coronary flow was monitored during MPC infusion , and cardiac function was assessed using invasive hemodynamics and echocardiography at baseline and during 8 weeks follow-up . Coronary flow remained within thrombolysis in myocardial infa rct ion III definitions in all sheep during MPC infusion . Global left ventricular ejection fraction as measured by pressure – volume loop analysis deteriorated in controls to 40.7±2.6 % after 8 weeks . In contrast , MPC treatment improved cardiac function to 52.8±0.7 % . Echocardiography revealed significant improvement of both global and regional cardiac functions . Infa rct size decreased by 40 % in treated sheep , whereas infa rct and border zone thickness were enhanced . Left ventricular adverse remodeling was abrogated by MPC therapy , result ing in a marked reduction of left ventricular volumes . Blood vessel density increased by > 50 % in the infa rct and border areas . Compensatory cardiomyocyte hypertrophy was reduced in border and remote segments , accompanied by reduced collagen deposition and apoptosis . No microinfa rct ions in remote myocardial segments or histological abnormalities in unrelated organs were found . Conclusions : Intracoronary infusion of allogeneic MPCs is safe , feasible , and markedly effective in a large animal model of acute myocardial infa rct ion BACKGROUND Pilot trials suggest that the intracoronary administration of autologous progenitor cells may improve left ventricular function after acute myocardial infa rct ion . METHODS In a multicenter trial , we r and omly assigned 204 patients with acute myocardial infa rct ion to receive an intracoronary infusion of progenitor cells derived from bone marrow ( BMC ) or placebo medium into the infa rct artery 3 to 7 days after successful reperfusion therapy . RESULTS At 4 months , the absolute improvement in the global left ventricular ejection fraction ( LVEF ) was significantly greater in the BMC group than in the placebo group ( mean [ + /-SD ] increase , 5.5+/-7.3 % vs. 3.0+/-6.5 % ; P=0.01 ) . Patients with a baseline LVEF at or below the median value of 48.9 % derived the most benefit ( absolute improvement in LVEF , 5.0 % ; 95 % confidence interval , 2.0 to 8.1 ) . At 1 year , intracoronary infusion of BMC was associated with a reduction in the prespecified combined clinical end point of death , recurrence of myocardial infa rct ion , and any revascularization procedure ( P=0.01 ) . CONCLUSIONS Intracoronary administration of BMC is associated with improved recovery of left ventricular contractile function in patients with acute myocardial infa rct ion . Large-scale studies are warranted to examine the potential effects of progenitor-cell administration on morbidity and mortality Background The use of adult stem cells is limited by the quality and quantity of host stem cells . It has been demonstrated that Wharton ’s jelly – derived mesenchymal stem cells ( WJMSCs ) , a primitive stromal population , could integrate into ischemic cardiac tissues and significantly improve heart function . In this r and omized , controlled trial , our aim was to assess the safety and efficacy of intracoronary WJMSCs in patients with ST-elevation acute myocardial infa rct ion ( AMI ) . Methods In a multicenter trial , 116 patients with acute ST-elevation MI were r and omly assigned to receive an intracoronary infusion of WJMSCs or placebo into the infa rct artery at five to seven days after successful reperfusion therapy . The primary endpoint of safety : the incidence of adverse events ( AEs ) within 18 months , was monitored and quantified . The endpoint of efficacy : the absolute changes in myocardial viability and perfusion of the infa rct ed region from baseline to four months , global left ventricular ejection fraction ( LVEF ) from baseline to 18 months were measured using F-18-fluorodeoxyglucose positron emission computed tomography ( F-18-FDG-PET ) and 99mTc-sestamibi single-photon emission computed tomography ( 99mTc-SPECT ) , and two-dimensional echocardiography , respectively . Results During 18 months follow-up , AEs rates and laboratory tests including tumor , immune , and hematologic indexes were not different between the two groups . The absolute increase in the myocardial viability ( PET ) and perfusion within the infa rct ed territory ( SPECT ) was significantly greater in the WJMSC group [ 6.9 ± 0.6 % ( 95 % CI , 5.7 to 8.2 ) ] and [ 7.1 ± 0.8 % ( 95 % CI , 5.4 to 8.8 ) than in the placebo group [ 3.3 ± 0.7 % ( 95 % CI , 1.8 to 4.7 ) , P < 0.0001 ] and 3.9 ± 0.6(95 % CI , 2.8 to 5.0 ) , P = 0.002 ] at four months . The absolute increase in the LVEF at 18 months in the WJMSC group was significantly greater than that in the placebo group [ 7.8 ± 0.9 ( 6.0 to approximately 9.7 ) vs. 2.8 ± 1.2 ( 0.4 to approximately 5.1 ) , P = 0.001 ] . Concomitantly , the absolute decreases in LV end-systolic volumes and end-diastolic volumes at 18 months in the WJMSC group were significantly greater than those in the placebo group ( P = 0.0004 , P = 0.004 , respectively ) . Conclusions Intracoronary infusion of WJMSCs is safe and effective in patients with AMI , providing clinical ly relevant therapy within a favorable time window . This study encourages additional clinical trials to determine whether WJMSCs may serve as a novel alternative to BMSCs for cardiac stem cell-based therapy . Trial registration Clinical Trials NCT01291329 ( 02/05/2011 ) Recent studies suggest that the intracoronary administration of bone marrow (BM)-derived mesenchymal stem cells ( MSCs ) may improve left ventricular function in patients with acute myocardial infa rct ion ( AMI ) . However , there is still argumentative for the safety and efficacy of MSCs in the AMI setting . We thus performed a r and omized pilot study to investigate the safety and efficacy of MSCs in patients with AMI . Eighty patients with AMI after successful reperfusion therapy were r and omly assigned and received an intracoronary administration of autologous BM-derived MSCs into the infa rct related artery at 1 month . During follow-up period , 58 patients completed the trial . The primary endpoint was changes in left ventricular ejection fraction ( LVEF ) by single-photon emission computed tomography ( SPECT ) at 6 month . We also evaluated treatment-related adverse events . The absolute improvement in the LVEF by SPECT at 6 month was greater in the BM-derived MSCs group than in the control group ( 5.9%±8.5 % vs 1.6%±7.0 % ; P=0.037 ) . There was no treatment-related toxicity during intracoronary administration of MSCs . No significant adverse cardiovascular events occurred during follow-up . In conclusion , the intracoronary infusion of human BM-derived MSCs at 1 month is tolerable and safe with modest improvement in LVEF at 6-month follow-up by SPECT . ( Clinical Trials.gov registration number : NCT01392105 BACKGROUND There are only few data on long-term effectiveness of the stem cell therapy . AIM We studied the time course of global and regional left ventricular function in patients with acute myocardial infa rct ion within 1 year after the autologous mononuclear bone marrow cell transplantation . METHODS Sixty patients with a first acute myocardial infa rct ion , who had been r and omized into 3 groups , completed a 12-month protocol . Two groups were intracoronarily given bone marrow cells in either higher ( 10(8 ) cells , HD group , n=20 ) or lower ( 10(7 ) cells , LD group , n=20 ) doses . Twenty patients without cell transplantation served as a control ( C ) group . Doppler tissue imaging and the gated technetium-99 m sestamibi single photon emission computed tomography were performed before cell transplantation and at 3 , 6 , and 12 months later . RESULTS The baseline peak systolic velocities of longitudinal contraction of the infa rct ed wall ( S(infa rct ) ) of 5.2 cm/s , 4.6 cm/s , and 4.4 cm/s in C , LD , and HD groups increased by 0.0 cm/s , 0.3 cm/s ( p = NS vs. C group ) , and by 0.7 cm/s ( p<0.05 vs. C group ) , respectively , at 3 months . At 12 months , however , the corresponding changes from baseline values of 0.1 cm/s , 0.2 cm/s , and 0.6 cm/s did not differ significantly ( all p = NS ) . In contrast , the post-transplant improvements in the left ventricular ejection fraction by 6 % , 7 % , and 7 % at months 3 , 6 , and 12 , respectively , were preserved in HD group patients during the whole 12-month follow-up and remained significantly better as compared to controls . CONCLUSIONS In our study , the autologous mononuclear bone marrow cell transplantation provided sustained improvement in global left ventricular systolic function in patients with acute myocardial infa rct ion . However , when evaluating regional systolic function of the infa rct ed wall , the short-term benefit was partially lost during the 12-month follow-up Objectives : Intracoronary cell transplantation during catheter balloon inflations may be associated with \n Output:\n " }, { "from": "agent", "value": "Conclusions Transplantation time and injected cell dose are key factors that determine the therapeutic effect of stem cell therapy .\nThe injection of no more than 107 MSCs within 1 week for AMI after percutaneous coronary intervention might improve left ventricular systolic function ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND There is little in the literature to guide clinicians in advising patients regarding their return to work following a primary total knee arthroplasty . In this study , we aim ed to identify which factors are important in estimating a patient 's time to return to work following primary total knee arthroplasty , how long patients can anticipate being off from work , and the types of jobs to which patients are able to return following primary total knee arthroplasty . METHODS A prospect i ve cohort study was performed in which patients scheduled for a primary total knee arthroplasty completed a vali date d question naire preoperatively and at four to six weeks , three months , and six months postoperatively . The question naire assessed the patient 's occupational physical dem and s , ability to perform job responsibilities , physical status , and motivation to return to work as well as factors that may impact his or her recovery and other workplace characteristics . Two survival analysis models were constructed to evaluate the time to return to work either at least part-time or full-time . Acceleration factors were calculated to indicate the relative percentage of time until the patient returned to work . RESULTS The median time to return to work was 8.9 weeks . Patients who reported a sense of urgency about returning to work were found to return in half the time taken by other employees ( acceleration factor = 0.468 ; p < 0.001 ) . Other preoperative factors associated with a faster return to work included being female ( acceleration factor = 0.783 ) , self-employment ( acceleration factor = 0.792 ) , higher mental health scores ( acceleration factor = 0.891 ) , higher physical function scores ( acceleration factor = 0.809 ) , higher Functional Comorbidity Index scores ( acceleration factor = 0.914 ) , and a h and icap accessible workplace ( acceleration factor = 0.736 ) . A slower return to work was associated with having less pain preoperatively ( acceleration factor = 1.132 ) , having a more physically dem and ing job ( acceleration factor = 1.116 ) , and receiving Workers ' Compensation ( acceleration factor = 4.360 ) . CONCLUSIONS Although the physical dem and s of a patient 's job have a moderate influence on the patient 's ability to return to work following a primary total knee arthroplasty , the patient 's characteristics , particularly motivation , play a more important role Background Prior investigations have suggested that physician-related factors may contribute to differential use of TKA among women and ethnic minorities . We sought to evaluate the effect of surgeon bias on recommendations for TKA . Questions / purpose Using an experimental approach with st and ardized patient scenarios , we sought to evaluate surgeon recommendations regarding TKA , specifically to determine whether recommendations for TKA are influenced by ( 1 ) patient race , and ( 2 ) patient sex . Methods We developed four computerized scenarios for all combinations of race ( white or black ) and sex ( male or female ) for otherwise similar patients with end-stage knee osteoarthritis . Patients gave an orthopaedic history of 2 years worsening pain with decreased functional status and failure of oral antiinflammatory medications and corticosteroid intraarticular injections . Orthopaedic surgeons attending the 2012 annual meetings of the New York State Society of Orthopaedic Surgeons and American Association of Hip and Knee Surgeons were recruited for the study . Surgeons passing an open recruitment table at each meeting were asked to participate . Of the 1111 surgeons in attendance at either meeting , 113 ( 10.2 % ) participated in the study . All participants viewed the “ control ” patient ’s story ( white male ) and were r and omized to view one of the three “ experimental ” scenarios ( white female , black male , black female ) . After viewing each scenario , the participants were anonymously asked whether they would recommend TKA . An a priori power analysis showed that 112 participants were needed to detect a 15 % difference in the likelihood of recommending surgery for white versus nonwhite patients in the test scenarios evaluated with 90 % power at a level of significance of 0.05 . Results Of the 39 surgeons who viewed the white male plus black female scenario , there were 33 ( 85 % ) concordant responses ( TKA offered to both patients ) and six discordant responses ( TKA offered to only one of the patients ) , with no effect of patient race and sex ( p = 0.99 ) . Of the 37 surgeons who viewed the white male plus black male scenario , there were 33 ( 89 % ) concordant responses and four discordant responses , with no effect of patient race ( p = 0.32 ) . Of the 37 surgeons who viewed the white male plus white female scenario , there were 30 ( 77 % ) concordant responses and seven discordant responses , with no effect of patient sex ( p = 0.71 ) . Conclusion After orthopaedic surgeons viewed video scenarios of patients with end-stage knee osteoarthritis , patient race and sex were not associated with a different likelihood of a surgical recommendation . Our findings support the notion that patient race and sex may be less influential on decision making when there are strong clinical data to support a decision . Physician bias may have a greater effect on decision making in situations where the indications for surgery are less clear The purpose of this study was to compare patient demographics and factors recorded at the time of surgery between patients that were either satisfied or dissatisfied with their TKA at mid-term follow-up . From our prospect i ve outcomes data base , 989 primary TKAs with complete preoperative and intraoperative data were identified . At mean follow-up of 3.5 years , 94/989 TKAs ( 9.5 % ) were not satisfied with their TKA . African American patients were 3.0 times more likely to be dissatisfied than Caucasians ( 95 % CI = 1.5 - 6.0 , P = .003 ) . Patients with less severe degenerative changes were 2.1 times more likely to be dissatisfied ( 95 % CI = 1.3 - 3.2 , P = .001 ) Total knee arthroplasty has provided dramatic improvements in function and pain for the majority of patients with knee arthritis , yet a significant proportion of patients remain dissatisfied with their results . We performed a prospect i ve analysis of 215 patients undergoing TKA who underwent a comprehensive array of evaluations to discover whether any preoperative assessment could predict high pain scores and functional limitations postoperatively . Patients with severe pain with a simple knee range-of-motion test prior to TKA had a 10 times higher likelihood of moderate to severe pain at 6 months . A simple test of pain intensity with active flexion and extension preoperatively was a significant predictor of postoperative pain at 6 months after surgery . Strategies to address this particular patient group may improve satisfaction rates of TKA \n Output:\n " }, { "from": "agent", "value": "US blacks may derive less benefit from TKA than whites as measured by HRQOL , pain , function , and satisfaction ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The ventral tegmental area ( VTA ) has been primarily implicated in reward-motivated behavior . Recently , aberrant dopaminergic VTA signaling has also been implicated in anxiety-like behaviors in animal models . These findings , however , have yet to be extended to anxiety in humans . Here we hypothesized that clinical anxiety is linked to dysfunction of the mesocorticolimbic circuit during threat processing in humans ; specifically , excessive or dysregulated activity of the mesocorticolimbic aversion circuit may be etiologically related to errors in distinguishing cues of threat versus safety , also known as “ overgeneralization of fear . ” To test this , we recruited 32 females with generalized anxiety disorder and 25 age-matched healthy control females . We measured brain activity using fMRI while participants underwent a fear generalization task consisting of pseudo-r and omly presented rectangles with systematic ally varying widths . A mid-sized rectangle served as a conditioned stimulus ( CS ; 50 % electric shock probability ) and rectangles with widths of CS ±20 % , ±40 % , and ±60 % served as generalization stimuli ( GS ; never paired with electric shock ) . Healthy controls showed VTA reactivity proportional to the cue 's perceptual similarity to CS ( threat ) . In contrast , patients with generalized anxiety disorder showed heightened and less discriminating VTA reactivity to GS , a feature that was positively correlated with trait anxiety , as well as increased mesocortical and decreased mesohippocampal coupling . Our results suggest that the human VTA and the mesocorticolimbic system play a crucial role in threat processing , and that abnormalities in this system are implicated in maladaptive threat processing in clinical anxiety The role of worry in generalized anxiety disorder ( GAD ) has been posited to serve as an avoidance of emotional experience , and emotion regulation deficits in GAD have been found in several previous studies . It remains unclear whether those with GAD experience more dysregulated emotions during periods of euthymia and positive affect or whether these deficits occur only during periods of worry . Individuals with GAD ( with and without co-occurring dysphoria ) and non-anxious controls were r and omly assigned to receive a worry , neutral , or relaxation induction . Following the induction , all participants viewed a film clip documented to elicit sadness . Intensity of emotions and emotion regulation were examined following the induction period and film clip . The results revealed that , regardless of co-occurring dysphoria , individuals with GAD in the worry condition experienced more intense depressed affect than GAD participants in the other conditions and controls participants . In contrast , presence of worry appeared to have less impact on indices of emotion dysregulation , which were greater in participants with GAD compared to controls , but largely insensitive to context ual effects of worry or of relaxation . Following film viewing , both GAD participants with and without dysphoria displayed poorer underst and ing , acceptance , and management of emotions than did controls . However , acceptance and management deficits were most pronounced in individuals with both GAD and co-occurring dysphoria . Implication s for the role of emotions in conceptualization and treatment of GAD are discussed Theory of Mind ( ToM ) , the ability to attribute mental states to others , and empathy , the ability to infer emotional experiences , are important processes in social cognition . Brain imaging studies in healthy subjects have described a brain system involving medial prefrontal cortex , superior temporal sulcus and temporal pole in ToM processing . Studies investigating networks associated with empathic responding also suggest involvement of temporal and frontal lobe regions . In this fMRI study , we used a cartoon task derived from Sarfati et al. ( 1997 ) [ Sarfati , Y. , Hardy-Bayle , M.C. , Besche , C. , Widlocher , D. 1997 . Attribution of intentions to others in people with schizophrenia : a non-verbal exploration with comic strips . Schizophrenia Research 25 , 199 - 209.]with both ToM and empathy stimuli in order to allow comparison of brain activations in these two processes . Results of 13 right-h and ed , healthy , male volunteers were included . Functional images were acquired using a 1.5 T Phillips Gyroscan . Our results confirmed that ToM and empathy stimuli are associated with overlapping but distinct neuronal networks . Common areas of activation included the medial prefrontal cortex , temporoparietal junction and temporal poles . Compared to the empathy condition , ToM stimuli revealed increased activations in lateral orbitofrontal cortex , middle frontal gyrus , cuneus and superior temporal gyrus . Empathy , on the other h and , was associated with enhanced activations of paracingulate , anterior and posterior cingulate and amygdala . We therefore suggest that ToM and empathy both rely on networks associated with making inferences about mental states of others . However , empathic responding requires the additional recruitment of networks involved in emotional processing . These results have implication s for our underst and ing of disorders characterized by impairments of social cognition , such as autism and psychopathy As a central fear processor of the brain , the amygdala initiates a cascade of critical physiological and behavioral responses . Neuroimaging studies have shown that the human amygdala responds not only to fearful and angry facial expressions but also to fearful and threatening scenes such as attacks , explosions , and mutilations . Given the relative importance of facial expressions in adaptive social behavior , we hypothesized that the human amygdala would exhibit a stronger response to angry and fearful facial expressions in comparison to other fearful and threatening stimuli . Twelve subjects completed two tasks while undergoing fMRI : matching angry or fearful facial expressions , and matching scenes depicting fearful or threatening situations derived from the International Affective Picture System ( IAPS ) . While there was an amygdala response to both facial expressions and IAPS stimuli , direct comparison revealed that the amygdala response to facial expressions was significantly greater than that to IAPS stimuli . Autonomic reactivity , measured by skin conductance responses , was also greater to facial expressions . These results suggest that the human amygdala shows a stronger response to affective facial expressions than to scenes , a bias that should be considered in the design of experimental paradigms interested in probing amygdala function Mindfulness training aims to impact emotion regulation . Generalized anxiety disorder ( GAD ) symptoms can be successfully addressed through mindfulness-based interventions . This preliminary study is the first to investigate neural mechanisms of symptom improvements in GAD following mindfulness training . Furthermore , we compared brain activation between GAD patients and healthy participants at baseline . 26 patients with a current DSM-IV GAD diagnosis were r and omized to an 8-week Mindfulness Based Stress Reduction ( MBSR , N = 15 ) or a stress management education ( SME , N = 11 ) active control program . 26 healthy participants were included for baseline comparisons . BOLD response was assessed with fMRI during affect labeling of angry and neutral facial expressions . At baseline , GAD patients showed higher amygdala activation than healthy participants in response to neutral , but not angry faces , suggesting that ambiguous stimuli reveal stronger reactivity in GAD patients . In patients , amygdala activation in response to neutral faces decreased following both interventions . BOLD response in ventrolateral prefrontal regions ( VLPFC ) showed greater increase in MBSR than SME participants . Functional connectivity between amygdala and PFC regions increased significantly pre- to post-intervention within the MBSR , but not SME group . Both , change in VLPFC activation and amygdala – prefrontal connectivity were correlated with change in Beck Anxiety Inventory ( BAI ) scores , suggesting clinical relevance of these changes . Amygdala – prefrontal connectivity turned from negative coupling ( typically seen in down-regulation of emotions ) , to positive coupling ; potentially suggesting a unique mechanism of mindfulness . Findings suggest that in GAD , mindfulness training leads to changes in fronto-limbic areas crucial for the regulation of emotion ; these changes correspond with reported symptom improvements BACKGROUND Functional magnetic resonance imaging ( fMRI ) holds promise as a noninvasive means of identifying neural responses that can be used to predict treatment response before beginning a drug trial . Imaging paradigms employing facial expressions as presented stimuli have been shown to activate the amygdala and anterior cingulate cortex ( ACC ) . Here , we sought to determine whether pretreatment amygdala and rostral ACC ( rACC ) reactivity to facial expressions could predict treatment outcomes in patients with generalized anxiety disorder ( GAD ) . METHODS Fifteen subjects ( 12 female subjects ) with GAD participated in an open-label venlafaxine treatment trial . Functional magnetic resonance imaging responses to facial expressions of emotion collected before subjects began treatment were compared with changes in anxiety following 8 weeks of venlafaxine administration . In addition , the magnitude of fMRI responses of subjects with GAD were compared with that of 15 control subjects ( 12 female subjects ) who did not have GAD and did not receive venlafaxine treatment . RESULTS The magnitude of treatment response was predicted by greater pretreatment reactivity to fearful faces in rACC and lesser reactivity in the amygdala . These individual differences in pretreatment rACC and amygdala reactivity within the GAD group were observed despite the fact that 1 ) the overall magnitude of pretreatment rACC and amygdala reactivity did not differ between subjects with GAD and control subjects and 2 ) there was no main effect of treatment on rACC-amygdala reactivity in the GAD group . CONCLUSIONS These findings show that this pattern of rACC-amygdala responsivity could prove useful as a predictor of venlafaxine treatment response in patients with GAD Although the role of emotion in socioeconomic decision making is increasingly recognised , the impact of specific emotional disorders , such as anxiety disorders , on these decisions has been surprisingly neglected . Twenty anxious patients and twenty matched controls completed a commonly used socioeconomic task ( the Ultimatum Game ) , in which they had to accept or reject monetary offers from other players . Anxious patients accepted significantly more unfair offers than controls . We discuss the implication s of these findings in light of recent models of anxiety , in particular the importance of interpersonal factors and assertiveness in an integrated model of decision making . Finally , we were able to show that pharmacological serotonin used to treat anxious symptomatology tended to normalise decision making , further confirming and extending the role of serotonin in co-operation , prosocial behaviour , and social decision making . These results show , for the first time , a different pattern of socioeconomic behaviour in anxiety disordered patients , in addition to the known memory , attentional and emotional biases that are part of this pathological condition More than half of anxiety and depression patients treated with an adequate course of antidepressants fail to fully improve . We retrospectively examined whether treatment-resistant depression and anxiety disorder patients responded to and tolerated augmentation with the atypical antipsychotic , aripiprazole . We report on patients with depression and anxiety disorders , including panic disorder , generalized anxiety disorder , social anxiety and post-traumatic stress disorder , who had an incomplete response to a variety of selective serotonin reuptake inhibitors ( SSRIs ) and who received augmentation with aripiprazole . The primary outcome measure was the Clinical Global Impression of Improvement ( CGI-I ) . In the intent-to-treat analysis , the mean±SD CGI-S was 3.8±1.3 at endpoint . Fifty-nine percent of subjects received CGI-I ratings of 1 or 2 , ‘ much improved ’ or ‘ very much improved , ’ in terms of their depression and anxiety symptoms at the end of 12 weeks . Several patients showed an early ( weeks 1–5 ) , as well as sustained , response to augmentation with doses of aripiprazole between 15 and 30 mg/day . The results suggest that aripiprazole may be effective as an augmentation for patients with persistent depressive and anxiety disorders despite initial SSRI treatment . Because this is a retrospective case review , further prospect i ve studies are required to confirm these findings This study investigated the temporal pattern of brain response to emotional stimuli during 28 days of alprazolam treatment among patients with generalized anxiety disorder ( GAD ) r and omized 2:1 to drug or placebo in a double-blind design . Functional magnetic resonance imaging scans obtained during an emotion face matching task ( EFMT ) and an affective stimulus expectancy task ( STIMEX ) were performed at baseline , one hour after initial drug administration and 28 days later . Alprazolam significantly reduced scores on the Hamilton Anxiety Scale and the Penn State Worry Question naire after one week and 28 days of treatment . Brain activation in the amygdala during the EFMT and in the insula during the STIMEX was reduced one hour after alprazolam administration but returned to baseline levels at Day 28 . Exploratory analyses revealed significant treatment differences in brain activity during the STIMEX on Day 28 in frontal lobe , cau date nucleus , middle temporal gyrus , secondary visual cortex , and supramarginal gyrus . These results are consistent with the notion that the neural mechanisms supporting sustained treatment effects of benzodiazepines in GAD differ from those underlying their acute effects Some research ers have recently suggested that antidepressants may be superior to benzodiazepines in the alleviation of generalized anxiety . In a 6-week , double-blind , parallel- design study with flexible dosage scheduling , the authors compared the effects of alprazolam with those of imipramine in 60 patients who had generalized anxiety disorder . On rating scales that contained both psychic and somatic symptoms , patients in both treatment groups improved to a similar degree after 2 weeks . However , alprazolam was more effective in attenuating somatic symptoms , and imipramine was more effective in attenuating psychic symptoms such as dysphoria and negative anticipatory thinking . The authors ' results suggest that , in generalized anxiety , somatic symptoms and hyperarousal selectively respond to drugs acting on the gamma \n Output:\n " }, { "from": "agent", "value": "RESULTS The available studies have shown impairments in ventrolateral and dorsolateral prefrontal cortex , anterior cingulate , posterior parietal regions , and amygdala in both pediatric and adult GAD patients , mostly in the right hemisphere ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The purpose of this study is to assess cardiovascular responses to lower body positive pressure ( LBPP ) and to examine the effects of LBPP unloading on gait mechanics during treadmill ambulation . We hypothesized that LBPP allows comfortable unloading of the body with minimal impact on the cardiovascular system and gait parameters . Fifteen healthy male and female subjects ( 22 - 55 yr ) volunteered for the study . Nine underwent noninvasive cardiovascular studies while st and ing and ambulating upright in LBPP , and six completed a gait analysis protocol . During stance , heart rate decreased significantly from 83 + /- 3 beats/min in ambient pressure to 73 + /- 3 beats/min at 50 mmHg LBPP ( P < 0.05 ) . During ambulation in LBPP at 3 mph ( 1.34 m/s ) , heart rate decreased significantly from 99 + /- 4 beats/min in ambient pressure to 84 + /- 2 beats/min at 50 mmHg LBPP ( P < 0.009 ) . Blood pressure , brain oxygenation , blood flow velocity through the middle cerebral artery , and head skin microvascular blood flow did not change significantly with LBPP . As allowed by LBPP , ambulating at 60 and 20 % body weight decreased ground reaction force ( P < 0.05 ) , whereas knee and ankle sagittal ranges of motion remained unaffected . In conclusion , ambulating in LBPP has no adverse impact on the systemic and head cardiovascular parameters while producing significant unweighting and minimal alterations in gait kinematics . Therefore , ambulating within LBPP is potentially a new and safe rehabilitation tool for patients to reduce loads on lower body musculoskeletal structures while preserving gait mechanics Walking humans conserve mechanical and , presumably , metabolic energy with an inverted pendulum-like exchange of gravitational potential energy and horizontal kinetic energy . Walking in simulated reduced gravity involves a relatively high metabolic cost , suggesting that the inverted-pendulum mechanism is disrupted because of a mismatch of potential and kinetic energy . We tested this hypothesis by measuring the fluctuations and exchange of mechanical energy of the center of mass at different combinations of velocity and simulated reduced gravity . Subjects walked with smaller fluctuations in horizontal velocity in lower gravity , such that the ratio of horizontal kinetic to gravitational potential energy fluctuations remained constant over a fourfold change in gravity . The amount of exchange , or percent recovery , at 1.00 m/s was not significantly different at 1.00 , 0.75 , and 0.50 G ( average 64.4 % ) , although it decreased to 48 % at 0.25 G. As a result , the amount of work performed on the center of mass does not explain the relatively high metabolic cost of walking in simulated reduced gravity The Hoffmann ( H- ) reflex is an electrical analogue of the monosynaptic stretch reflex , elicited by bypassing the muscle spindle and directly stimulating the afferent nerve . Study ing H-reflex modulation provides insight into how the nervous system central ly modulates stretch reflex responses . A common measure of H-reflex gain is the slope of the relationship between H-reflex amplitude and EMG amplitude . To examine soleus H-reflex gain across a range of EMG levels during human locomotion , we used simulated reduced gravity to reduce muscle activity . We hypothesised that H-reflex gain would be independent of gravity level . We recorded EMG from eight subjects walking ( 1.25 m s-1 ) and running ( 3.0 m s-1 ) at four gravity levels ( 1.0 , 0.75 , 0.5 and 0.25 G ( Earth gravity ) ) . We normalised the stimulus M-wave and result ing H-reflex to the maximal M-wave amplitude ( Mmax ) elicited throughout the stride to correct for movement of stimulus and recording electrodes relative to nerve and muscle fibres . Peak soleus EMG amplitude decreased by ~30 % for walking and for running over the fourfold change in gravity . As hypothesised , slopes of linear regressions fitted to H-reflex versus EMG data were independent of gravity for walking and running ( ANOVA , P > 0.8 ) . The slopes were also independent of gait ( P > 0.6 ) , contrary to previous studies . Walking had a greater y-intercept ( 19.9 % Mmax ) than running ( -2.5 % Mmax ; P < 0.001 ) . At all levels of EMG , walking H-reflex amplitudes were higher than running H-reflex amplitudes by a constant amount . We conclude that the nervous system adjusts H-reflex threshold but not H-reflex gain between walking and running . These findings provide insight into potential neural mechanisms responsible for spinal modulation of the stretch reflex during human locomotion \n Output:\n " }, { "from": "agent", "value": "Studies investigating the immediate effects of partial gravity exposure reveal that cardiopulmonary parameters such as heart rate , oxygen consumption , metabolic rate , and cost of transport are reduced compared to 1 g , whereas stroke volume seems to increase with decreasing gravity levels .\nBiomechanical studies reveal that ground reaction forces , mechanical work , stance phase duration , stride frequency , duty factor and preferred walk-to-run transition speed are reduced compared to 1 g. Partial gravity exposure below 0.4 g seems to be insufficient to maintain musculoskeletal and cardiopulmonary properties in the long-term .\nTo compensate for the anticipated lack of mechanical and metabolic stimuli some form of exercise countermeasure appears to be necessary in order to maintain reasonable astronauts ' health , and thus ensure both sufficient work performance and mission safety" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To examine the rate of success and complications of Doppler-guided subclavian vein catheter insertion compared with st and ard insertion in patients considered at high risk for failure . DESIGN Prospect i ve , r and omized , crossover trial . SETTING University-affiliated tertiary care medical center . PATIENTS Two hundred forty patients were enrolled in the study . Patients were stratified for 3 known risk factors : ( 1 ) prior surgery in the subclavian vein region , ( 2 ) prior radiotherapy at the attempted catheterization site , and ( 3 ) an abnormal weight-height ratio . INTERVENTIONS Subclavian vein catheterization was performed either in st and ard or Doppler-guided fashion using the Smart Needle ( Peripheral Systems Group , Mountain View , Calif ) , which is a Doppler probe at the tip of a cannulating needle . If subclavian vein catheterization was unsuccessful after 2 attempts , patients were crossed over to the other technique . MAIN OUTCOME MEASURE Successful cannulation of the subclavian vein . RESULTS The success rate , either as an initial technique or as a salvage technique , and complication rate were not significantly different with use of the Smart Needle . A subgroup of physicians had a significantly lower success rate using the Smart Needle . CONCLUSIONS Doppler guidance did not increase the success rate or decrease the complication rate of subclavian vein catheterization when compared with the st and ard technique in high-risk patients . Doppler guidance was not more useful than the st and ard technique as a salvage technique following a previous failure of catheterization . Furthermore , real-time Doppler guidance of subclavian vein catheterization is a technique that is highly operator dependent STUDY OBJECTIVE To compare the use of real-time-ultrasound guidance with the st and ard l and mark-oriented approach for obtaining femoral vein catheterization in patients requiring intravenous access during CPR . METHODS Prospect i ve , r and omized , paired subject-controlled clinical trial in the setting of an urban teaching county hospital emergency department . The study comprised a convenience sample of 20 patients presenting with apnea and pulselessness in the ED . Each patient received bilateral femoral lines , one by ultrasound guidance and one by the l and mark approach ( control ) . R and omization determined which technique and which side would be attempted first . The following parameters were recorded : time to initial flash of blood , time to completion of catheterization , number of needle passes , and rate of arterial catheterization . CPR and Advanced Cardiac Life Support protocol s were continued during both procedures . RESULTS Real-time ultrasound-guided catheterization had a higher success rate ( 90 % versus 65 % , P = .058 ) , a lower number of needle passes ( 2.3 + /- 3 versus 5.0 + /- 5 , P = .0057 ) , and a lower rate of arterial catheterization ( 0 % versus 20 % , P = .025 ) than the st and ard l and mark-oriented approach . Ultrasound was also slightly faster in time to blood flash and in time to catheterization . An incidental finding of interest was that real-time ultrasound demonstrated the presence of femoral vein pulsations during CPR . CONCLUSION Real-time ultrasound-guided femoral vein catheterization was faster and produced a lower rate of inadvertent arterial catheterization and a higher rate of success during CPR than the st and ard l and mark-oriented approach . Also , ultrasound demonstrated that palpable femoral pulsation during CPR is venous rather than arterial BACKGROUND Central venous access is a m and atory part of patient management in many clinical setting s and is usually achieved with a blind , external l and mark-guided technique . The purpose of this study is to evaluate whether an ultrasound technique can improve on the external l and mark method . METHODS We prospect ively evaluated an ultrasound-guided method in 28 patients undergoing femoral vein cannulation for acute haemodialysis access and compared the results with 38 patients in whom an external l and mark-guided technique was used . External l and mark-guided technique was done by manual localization of the femoral artery in the femoral triangle inferior to the inguinal ligament with needle insertion medial to the artery . Ultrasound-guided cannulation was performed in the same location with the aid of an ultrasound device ( Site-Rite , Dymax Corp. , USA ) with a 7.5 MHz transducer covered by a sterile sheath . RESULTS Cannulation of the femoral vein was achieved in all patients ( 100 % ) using ultrasound and in 34 patients ( 89.5 % ) using the l and mark-guided technique . The vein was entered on the first attempt in 92.9 % of patients using ultrasound and in 55.3 % using the l and mark technique ( P < 0.05 ) . Average access time ( skin to vein ) was similar but total procedure time was 45.1 + /- 18.8 s by the ultrasound approach and 79.4 + /- 61.7 s by the l and mark approach ( P < 0.05 ) . Using ultrasound , puncture of the femoral artery occurred in 7.1 % of patients , and haematoma in 0 % . Using external l and mark technique , puncture of the femoral artery occurred in 15.8 % of patients , and haematoma in 2.6 % . CONCLUSIONS Ultrasound-guided cannulation of the femoral vein reduces the time required for the procedure , reduces the number of passes needed to puncture the vein , and minimizes complications such as arterial puncture or haematoma BACKGROUND : Percutaneous cannulation of the femoral vein , in the pediatric age group , can be technically challenging , especially when performed by residents in training . We examined whether the use of real-time ultrasound guidance is superior to a l and mark technique for femoral vein catheterization in children undergoing heart surgery . METHODS : Patients were prospect ively r and omized into 2 groups . In group LM , the femoral vein was cannulated using the traditional method of palpation of arterial pulse . In group US , cannulation was guided by real-time scanning with an ultrasound probe . The time to complete cannulation ( primary outcome ) , success rate , number of needle passes , number of successful cannulations on first needle pass , and incidence of complications were compared between the 2 groups . RESULTS : Forty-eight pediatric patients were studied . The time to complete cannulation was significantly shorter ( 155 [ 46–690 ] vs 370 [ 45–1620 ] seconds ; P = 0.02 ) in group US versus group LM . The success rate was similar in both groups ( 95.8 % ) . The number of needle passes was smaller ( 1 [ 1–8 ] vs 3 [ 1–21 ] ; P = 0.001 ) and the number of successful cannulations on first needle pass higher ( 18 vs 6 ; P = 0.001 ) in group US compared with group LM . The incidence of femoral artery puncture was comparable between the 2 groups . CONCLUSIONS : Ultrasound-guided cannulation of the femoral vein , in pediatric patients , when performed by senior anesthesia residents , is superior to the l and mark technique in terms of speed and number of needle passes , with remarkable improvement in first attempt success Central venous cannulation allows accurate monitoring of right atrial pressure and infusion of drugs during the anaesthetic management of infants undergoing cardiopulmonary bypass . In this prospect i ve , r and omized study , we compared the success and speed of cannulation of the internal jugular vein in 45 infants weighing less than 10 kg using three modes of identification : auditory signals from internal ultrasound ( SmartNeedle , SM ) , external ultrasound imaging ( Imaging Method , IM ) and the traditional palpation of the carotid pulsation and other l and marks ( L and marks Method , LM ) . The cannulation time , number of attempts with LM and SM techniques were greater than those with IM technique . The incidence of carotid artery puncture and the success rate were not significantly different among the three groups . In infants , a method based on visual ultrasound identification ( IM ) of the internal jugular vein is more precise and efficient than methods based on auditory ( SM ) and tactile perception ( LM ) Objective : To determine whether ultrasound ( US ) increases successful central venous catheter ( CVC ) placement , decreases site attempts , and decreases CVC placement complications . Design and Setting : A prospect i ve observational cohort study evaluating a transition by the Pediatric Critical Care Medicine service to US-guided CVC placement . Medical and surgical patients in a 21-bed quaternary multidisciplinary pediatric intensive care unit had CVCs placed by attendings , fellows , residents , and a nurse practitioner . Patients : Ninety-three patients were prospect ively enrolled into the l and mark ( LM ) group and 119 into the US group . Interventions : After collection of prospect i ve LM data , training with US guidance was provided . CVCs were subsequently placed with US guidance . Measurements and Main Results : Operator information , disease process , emergent/routine , sites attempted , and complications were recorded . Procedure time was from initial skin puncture to guidewire placement . There was no difference overall in success rates ( 88.2 % LM vs. 90.8 % US , p = 0.54 ) or time to successful placement ( median seconds 269 LM vs. 150 US , p = 0.14 ) between the two groups . Median number of attempts were fewer with US for all CVCs attempted ( 3 vs. 1 , p < 0.001 ) as were attempts at > 1 anatomical site ( 20.7 % LM vs. 5.9 % US , p = 0.001 ) . Use of US was associated with fewer inadvertent artery punctures ( 8.5 % vs. 19.4 % , p = 0.03 ) . Time to successful placement by residents was decreased with US ( median 919 seconds vs. 405 seconds , p = 0.02 ) . More internal jugular CVCs were placed during the US period than during the LM period ( 13.4 % vs. 2.1 % ) . Conclusions : US-guided CVC placement in children is associated with decreased number of anatomical sites attempted and decreased number of attempts to gain placement . Time to placement by residents was decreased with US , but not the time to placement by other operators . US guidance increased the use of internal jugular catheter placement and decreased artery punctures . US guidance did not improve success rates Objective : Subclavian vein catheterization may cause various complications . We compared the real-time ultrasound-guided subclavian vein cannulation vs. the l and mark method in critical care patients . Design : Prospect i ve r and omized study . Setting : Medical intensive care unit of a tertiary medical center . Patients : Four hundred sixty-three mechanically ventilated patients enrolled in a r and omized controlled IS RCT N-registered trial ( IS RCT N-61258470 ) . Interventions : We compared the ultrasound-guided subclavian vein cannulation ( 200 patients ) vs. the l and mark method ( 201 patients ) using an infraclavicular needle insertion point in all cases . Catheterization was performed under nonemergency conditions in the intensive care unit . R and omization was performed by means of a computer-generated r and om-numbers table and patients were stratified with regard to age , gender , and body mass index . Measurements and Main Results : No significant differences in the presence of risk factors for difficult cannulation between the two groups of patients were recorded . Subclavian vein cannulation was achieved in 100 % of patients in the ultrasound group as compared with 87.5 % in the l and mark one ( p < .05 ) . Average access time and number of attempts were significantly reduced in the ultrasound group of patients compared with the l and mark group ( p < .05 ) . In the l and mark group , artery puncture and hematoma occurred in 5.4 % of patients , respectively , hemothorax in 4.4 % , pneumothorax in 4.9 % , brachial plexus injury in 2.9 % , phrenic nerve injury in 1.5 % , and cardiac tamponade in 0.5 % , which were all increased compared with the ultrasound group ( p < .05 ) . Catheter misplacements did not differ between groups . In this study , the real-time ultrasound method was rated on a semiquantitative scale as technically difficult by the participating physicians . Conclusions : The present data suggested that ultrasound-guided cannulation of the subclavian vein in critical care patients is superior to the l and mark method and should be the method of choice in these patients OBJECTIVE To compare ultrasound (US)-guided vs. l and mark-guided techniques for central venous access ( CVA ) in the emergency department . METHODS This was a prospect i ve study of consecutive patients enrolled at a university teaching hospital with an annual census of approximately 100,000 . On even days patients had CVA with ultrasonic assistance ; patients presenting on odd days had CVA via traditional l and mark techniques . Ultrasound users were emergency medicine faculty or residents who completed a one-hour training session . A data collection tool with 17 variables was completed for each central line placed . Variables were compared using the independent t-test , Fisher 's exact test , and the non-parametric Mann-Whitney U test . RESULTS Between August 1 , 2000 , and February 1 , 2001 , data for 122 subjects ( n = 51 for US , and n \n Output:\n " }, { "from": "agent", "value": "No evidence was found of a difference in inadvertent arterial puncture or other complications .\nOn the basis of available data , we conclude that two-dimensional ultrasound offers small gains in safety and quality when compared with an anatomical l and mark technique for subclavian ( arterial puncture , haematoma formation ) or femoral vein ( success on the first attempt ) cannulation for central vein catheterization ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: To compare the short-term effects of postural drainage with clapping ( PD ) and autogenic drainage ( AD ) on oxygen saturation , pulmonary function , and sputum recovery , we studied ten patients with cystic fibrosis ( CF ) r and omly treated with PD or AD on separate days . Pulse oximetry was monitored and sputum was collected during and for 1 h following each treatment . Pulmonary function was measured before and then 1 , 15 , and 60 min after each treatment . There was no significant difference in the amount of sputum recovered with AD ( 14.0 + /- 3.5 g ) vs PD ( 10.4 + /- 3.0 g ) and no significant differences in pulmonary function occurred . Oxygen saturation during PD fell from 93.3 + /- 0.7 % to 91.2 + /- 0.8 % ( p < 0.01 ) and required 15 min following treatment to return to baseline . Oxygen saturation did not fall during AD and increased to 94.5 + /- 0.7 % by 1 h following treatment ( baseline , 93.3 + /- 0.8 % ; p < 0.01 ) . We conclude that AD is less likely to produce oxygen desaturation and may be better tolerated by patients with CF , while producing similar benefits in sputum clearance Background High frequency chest wall oscillation ( HFCWO ) is st and ard treatment for airway clearance in the USA and has recently been introduced in the UK and Europe . There is little published research comparing HFCWO with airway clearance techniques ( ACTs ) frequently used in the UK and Europe . The aim of this study was to compare the short-term effects of HFCWO with usual ACTs in patients with cystic fibrosis hospitalised with an infective pulmonary exacerbation . Methods A 4-day r and omised crossover design was used . Patients received either HFCWO on days 1 and 3 and usual ACTs on days 2 and 4 or vice versa . Wet weight of sputum , spirometry and oxygen saturation were measured . Perceived efficacy , comfort , incidence of urinary leakage and preference were assessed . Data were analysed by mixed model analysis . Results 29 patients ( 72 % male ) of mean ( SD ) age 29.4 ( 8.4 ) years and mean ( SD ) forced expiratory volume in 1 s ( FEV1 ) percentage predicted ( FEV1 % ) 38 ( 16.7 ) completed the study . Significantly more sputum was expectorated during a single treatment session and over a 24 h period ( mean difference 4.4 g and 6.9 g , respectively ) with usual ACTs than with HFCWO ( p<0.001 ) . No statistically significant change in FEV1 % or oxygen saturation was observed after either HFCWO or usual ACTs compared with baseline . 17 patients ( 55 % ) expressed a preference for their usual ACT . Conclusions During both a finite treatment period and over 24 h , less sputum was cleared using HFCWO than usual ACT . HFCWO does not appear to cause any adverse physiological effects and may influence adherence Fourteen patients with cystic fibrosis were trained in 2 self-administered chest physiotherapy ( PT ) techniques : high-pressure PEP-mask physiotherapy ( PEP ) , and autogenic drainage ( AD ) . They then visited the clinic on 5 consecutive days , and , in a r and om order , performed 1 of the following : PEP , AD , PEP followed by AD ( PEP-AD ) , AD followed by PEP ( AD-PEP ) , and , no PT except for spontaneous coughing . Lung function was measured repeatedly before , during , and after PT ; time needed for and sputum produced by each form of PT was recorded . PEP produced the highest amount of sputum , followed by PEP-AD , AD-PEP , and AD ; all 4 forms of PT produced significantly more sputum than coughing . Lung function improved significantly after PEP , AD , and PEP-AD , but PEP-induced changes did not exceed those after AD . Within the investigated group , the PEP-induced lung function improvement per milliliter of sputum produced was significantly lower for those patients with airway hyperreactivity . The fact that the highest sputum yield with PEP was not reflected in higher PEP-effected lung function changes might thus be explained by PEP-induced bronchospasm in patients with airway hyperreactivity . PEP clears more sputum than AD or combined techniques ; patients with airway hyperreactivity , however , should either prefer AD or should take a bronchodilator premedication before PEP OBJECTIVE The aim of the present study was to investigate the efficacy of two frequently used physiotherapies ( PTs ) for the removal of bronchial secretions in cystic fibrosis ( CF ) lung disease : autogenic drainage ( AD ) and the Flutter ( Desitin in Germany ) . AD is believed to improve mucus clearance from peripheral to central airways due to airway caliber changes in combination with a special breathing technique . The Flutter is an easy-to-use physiotherapy device based on oscillations of a steel ball during expiration through a pipe-type device . MATERIAL S AND METHODS To evaluate the acute and chronic physiotherapy effects of these two techniques , 14 CF patients underwent either twice daily AD or Flutter treatment for 4 consecutive weeks in a r and omized crossover design . Prior to each therapy interval , for a 1-week wash-out period , no PT was administered , but patients continued regular medication . At the beginning and end of each 4-week interval , pulmonary function was measured before and after an acute 30-min therapy . At the end of the PT session , sputum was collected , weighed , and deep frozen until analyzed . The viscoelasticity of the sputum was evaluated using a magnetic microrheometer . RESULTS No significant changes were noted for FVC , FEV1 , or sputum volume throughout the study . Sputum viscoelasticity ( rigidity index ) , however , was significantly lower ( p<0.01 ) after therapy with the Flutter in comparison with AD , predicting improvements in mucociliary and cough clearability of the secretions . In a companion in vitro experiment , oscillations generated by passing humidified air over CF sputum lining an acrylic tube connected to a Flutter de-ice were found to decrease sputum elasticity , as measured by a filancemeter . These findings suggest that applied oscillations are capable of decreasing mucus viscoelasticity within the airways at frequencies and amplitudes achievable with the Flutter device , and provide direct evidence that PT can reduce the viscoelasticity of sputum QUESTION : Can a session of exercise with incorporated expiratory manoeuvres substitute for a session of breathing techniques for airway clearance in children with cystic fibrosis ? Are children with cystic fibrosis as co-operative and satisfied with the exercise regimen as with the breathing techniques ? . DESIGN R and omised , cross-over trial with concealed allocation and intention-to-treat analysis . PARTICIPANTS 34 children with cystic fibrosis in a stable clinical state . INTERVENTIONS Participants underwent two 20-min airway clearance interventions on two scheduled clinic days : one involving three bouts of various whole-body exercise modalities each followed by independent expiratory manoeuvres , and the other involving breathing control , thoracic expansions with manual expiratory compressions , and the forced expiratory technique . OUTCOME MEASURES Wet weight of expectorated sputum , change in lung function , co-operation with treatment , perceived treatment quality , and satisfaction with treatment were all assessed after each intervention . RESULTS The wet weight of sputum after exercise was 0.6 g higher after the exercise intervention , which was not statistically or clinical ly significant ( 95 % CI -0.2 to 1.4 ) . However , lung function and participant satisfaction with the treatment were both significantly better after the exercise intervention . Co-operation with treatment and perceived treatment quality were equally high for each intervention . CONCLUSION A session of various whole-body exercises interspersed with independent expiratory manoeuvres could be an acceptable substitute for a session of breathing control , thoracic expansions with manual expiratory compressions , and the forced expiratory technique in children with mild cystic fibrosis lung disease ABSTRACT Purpose : To determine the effects of short- and long-term use of autogenic drainage ( AD ) on pulmonary function and sputum recovery in people with cystic fibrosis ( CF ) . Methods : The authors conducted a systematic review of r and omized and quasi-r and omized clinical trials in which participants were people with CF who use AD as their sole airway clearance technique . Results : Search es in 4 data bases and secondary sources using 5 key terms yielded 735 articles , of which 58 contained the terms autogenic drainage and cystic fibrosis . Ultimately , 4 studies , 2 of which were long term , were included . All measured forced expiratory volume in 1 second ( FEV1 ) and found no change . The long-term studies were underpowered to detect change in FEV1 ; however , the short-term studies found a clinical ly significant sputum yield ( ≥4 g ) . Conclusion : AD has been shown to produce clinical ly significant sputum yields in a limited number of investigations . The effect of AD on the function of the pulmonary system remains uncertain , and questions have emerged regarding the appropriateness of FEV1 as a valid measure of airway clearance from peripheral lung regions . Further consideration should be given to the use of FEV1 as a primary measure of the effect of AD Background : Chest physiotherapy has been used for many years to assist in the removal of abnormal viscid bronchial secretions in cystic fibrosis ( CF ) patients . Objectives : This study compared the short-term effects of two physiotherapy regimens in patients with CF : autogenic drainage ( AD ) preceded by either saline inhalation ( ‘ salineNEB + AD ’ ) or by intrapulmonary percussive ventilation ( IPV ) with saline ( ‘ salineIPV + AD ’ ) . Methods : In a r and omized crossover design , 20 clinical ly stable CF patients with similar pulmonary function at baseline received either ‘ salineNEB + AD ’ or ‘ salineIPV + AD ’ on 2 consecutive days . Transcutaneous oxygen saturation , heart rate , Borg dyspnea score and mucus wet weight were evaluated after 15 min of either salineNEB or salineIPV , and after a subsequent 30 min of AD . Results : There were no significant changes in oxygen saturation , heart rate or Borg score at any point of either physiotherapy intervention . There was no significant difference in sputum wet weight recovered with either salineNEB ( 2.2 ± 1.8 g , mean ± SD ) or salineIPV ( 1.7 ± 1.9 g ) alone . Subsequent AD did produce significantly greater amounts of sputum wet weight ( p < 0.0001 for both ) than in the initial saline delivery period , yet the amount of wet weight was similar irrespective of whether AD was preceded by salineNEB ( 9.7 ± 6.5 g ) or salineIPV ( 11.6 ± 7.3 g ) . Conclusions : Recovered sputum weight is similar whether AD is preceded by salineNEB or salineIPV . The much greater amount of mucus obtained during the AD period than during the saline delivery period warrants further investigation Impaired mucociliary clearance due to defective ion and water transport and the effects of chronic airway infections lead to stasis of secretions and progressive pulmonary damage in patients with cystic fibrosis ( CF ) . Methods to improve removal of tenacious lung secretions in CF patients contribute to slowing the decline in respiratory function . We have evaluated an intrapulmonary percussive ventilator ( IPV ) , which is a device design ed to enhance airway clearance and preserve lung function . A previous pilot study by us had determined that the device was acceptable to patients and is safe . We undertook a 6 month parallel comparative trial of the IPV versus st and ard , manual chest physiotherapy in 16 CF children and adults . No significant differences in spirometric measures , numbers of hospitalizations , use of oral or IV antibiotics , or anthropometric measurements were detected between the st and ard aerosol/chest physiotherapy group and the IPV group over the duration of the trial . Patient acceptance , as determined by participant survey , was good . The device appeared to be safe and durable . It was concluded that the IPV is as effective as st and ard aerosol and chest physiotherapy in preserving lung function and anthropometric measures , and there was no difference in the use of antibiotics and hospitalizations UNLABELLED Preliminary examinations with an innovative device for physiotherapy , VRP 1-Desitin ( \" Flutter \" ) , in patients suffering from chronic mucus retention and bronchial collapse gave encouraging results . Therefore , we tried to confirm these findings and to evaluate the use of this new physiotherapy . It is based on oscillations of air in the respiratory tract during expiration ( rate about 2 to 32 Hertz ) diminishing adhesiveness of bronchial mucus and bronchial collapse . Pressure and flow changing depend on the position of mouth-piece and effort of breathing . In order to establish the efficiency of the VRP 1 a comparing investigation was initiated . 20 patients with cystic fibrosis , aged 7 to 28 years , performed physiotherapy with VRP 1 and autogenic drainage ( AD ) , respectively , in a r and omized order one after another , each physiotherapy taking twenty minutes . The expectorated sputum was weighed by means of a precision balance . Mean values during VRP 1 treatment were 5.0 g ( range 0 to 12.0 g ) , during AD 4.8 g ( range 0 to 11.7 g \n Output:\n " }, { "from": "agent", "value": "From the studies assessed , autogenic drainage was not found to be superior to any other form of airway clearance technique ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVES To examine the short-term effects of light pressure effleurage on circulating lymphocytes by study ing the number and activity of peripheral blood natural killer ( NK ) cells in patients with breast cancer compared to a control group . Furthermore , the effect of light pressure effleurage on salivary cortisol levels , heart rate and blood pressure was studied . DESIGN Single centre , prospect i ve , r and omized and controlled study . METHODS Thirty women , aged 50 to 75 years ( mean 61 sd=7.2 ) with breast cancer undergoing radiation therapy in a hospital in southwestern Sweden were enrolled in the study . They were allocated to either receive massage in the form of a full-body light pressure effleurage treatment , or a control visit where they were given an equal amount of attention . Blood sample s , saliva , notation of heart rate and blood pressure were collected before and after massage/control visit . Differences in change over time between groups were analyzed by Student 's t-test . RESULTS Light pressure effleurage massage decreased the deterioration of NK cell activity occurring during radiation therapy . Furthermore it lowered heart rate and systolic blood pressure . No effects were demonstrated on cortisol and diastolic pressure . CONCLUSIONS A single full-body light pressure effleurage massage has a short-term effect on NK cell activity , systolic blood pressure and heart rate in patients with breast cancer . However , the long-term clinical importance of these findings needs to be further investigated A r and omised controlled pilot study was carried out to examine the effects of adjunctive aromatherapy massage on mood , quality of life and physical symptoms in patients with cancer attending a specialist unit . Participants were r and omised to conventional day care alone or day care plus weekly aromatherapy massage using a st and ardised blend of oils for four weeks . At baseline and at weekly intervals , patients rated their mood , quality of life and the intensity and bother of two symptoms most important to them . Forty-six patients were recruited to the study . Due to a large number of withdrawals , only 11 of 23 ( 48 % ) patients in the aromatherapy group and 18 of 23 ( 78 % ) in the control group completed all four weeks . Mood , physical symptoms and quality of life improved in both groups . There was no statistically significant difference between groups in any of the outcome measures . Despite a lack of measurable benefit , all patients were satisfied with the aromatherapy and wished to continue . Whilst this pilot study has shown that a r and omised controlled trial of complementary therapy is feasible , it has also identified several areas that would require further consideration when design ing future studies , e.g. , the recruitment and retention of appropriate numbers of patients and the outcome measures used BACKGROUND Patients with colorectal cancer are usually treated with chemotherapy , which reduces the number of blood cells , especially white blood cells , and consequently increases the risk of infections . Some research studies have reported that aromatherapy massage affects the immune system and improves immune function by , for example , increasing the numbers of natural killer cells and peripheral blood lymphocytes . However , there has been no report of any study which provided good evidence as to whether aromatherapy with Thai massage could improve the immune system in patients with colorectal cancer . The objectives of this study were to determine whether the use of aromatherapy with light Thai massage in patients with colorectal cancer , who have received chemotherapy , can result in improvement of the cellular immunity and reduce the severity of the common symptoms of side effects . MATERIAL S AND METHODS Sixty-six patients with colorectal cancer in Phichit Hospital , Thail and , were enrolled in a single-blind , r and omised-controlled trial . The intervention consisted of three massage sessions with ginger and coconut oil over a 1-week period . The control group received st and ard supportive care only . Assessment s were conducted at pre- assessment and at the end of one week of massage or st and ard care . Changes from pre- assessment to the end of treatment were measured in terms of white blood cells , neutrophils , lymphocytes , CD4 and CD8 cells and the CD4/CD8 ratio and also the severity of self-rated symptom scores . RESULTS The main finding was that after adjusting for pre- assessment values the mean lymphocyte count at the post- assessment was significantly higher ( P=0.04 ) in the treatment group than in the controls . The size of this difference suggested that aromatherapy with Thai massage could boost lymphocyte numbers by 11 % . The secondary outcomes were that at the post assessment the symptom severity scores for fatigue , presenting symptom , pain and stress were significantly lower in the massage group than in the st and ard care controls . CONCLUSIONS Aromatherapy with light Thai massage can be beneficial for the immune systems of cancer patients who are undergoing chemotherapy by increasing the number of lymphocytes and can help to reduce the severity of common symptoms AIM To test whether reflexology was inferior to aromatherapy massage for ameliorating self-selected problems or concerns . DESIGN Non-blinded , r and omised study with a 1:1 allocation . Adult out patients recruited from a UK cancer centre , r and omised by the minimisation method to either four aromatherapy massage or four reflexology sessions . OUTCOME MEASURES MYCaW scores at baseline and completion ; VAS ( relaxation ) pre and post-sessions . ANALYSIS Unpaired t-test for the primary outcome ; analysis of variance tests for repeated measures for VAS ( relaxation ) ; descriptive statistics ( means and 95 % confidence intervals ) and content analysis for patient comments . RESULTS 115 subjects ( 58 aromatherapy massage , 57 reflexology ) recruited . Reflexology was found to be no less effective than aromatherapy massage for MYCaW first concerns ( p = 0.046 ) . There was no statistical difference between groups for MYCaW second concerns or overall well-being scores , proportions of patients gaining clinical benefit , VAS scores over time ( p = 0.489 ) or between groups ( p = 0.408 ) or in the written responses Women diagnosed with breast cancer received massage therapy or practice d progressive muscle relaxation ( PMR ) for 30-min sessions 3 times a week for 5 weeks or received st and ard treatment . The massage therapy and relaxation groups reported less depressed mood , anxiety , and pain immediately after their first and last sessions . By the end of the study , however , only the massage therapy group reported being less depressed and less angry and having more vigor . Dopamine levels , Natural Killer cells , and lymphocytes also increased from the first to the last day of the study for the massage therapy group . These findings highlight the benefit of these complementary therapies , most particularly massage therapy , for women with breast cancer OBJECTIVES massage can help relieve pain , although empirical evidence is scarce and contradictory . This study aims to assess the effectiveness of a massage protocol in relieving pain in children hospitalized with cancer . METHODS a r and omized , controlled , and single-blind trial was performed in a sample of 52 children aged between 10 and 18 years who were hospitalized in a pediatric cancer ward . The intervention consisted of the implementation of a massage protocol with three sessions of 20 to 30minutes on alternate days over a one-week period . The effectiveness of the protocol was evaluated by assessing pain using the Brief Pain Inventory ( BPI ) , while the effectiveness of each massage session was measured using the Visual Analogue Scale ( VAS ) . RESULTS the massage protocol was only effective in reducing the interference of pain in walking ( p<0.05 ) , although it also contributed to relieve pain and its impact on the children 's activities . After each massage session , the intensity of the pain experienced by the child decreased ( p<0.001 ) . CONCLUSIONS despite the small sample size , massage therapy appears to be a useful intervention in reducing pain in children with cancer . However , there are still questions regarding the effectiveness of this massage protocol . The authors recommend its use due to its contribution to the promotion of the child 's well-being and quality of life The objective of this study was to assess the impact of a Swedish massage intervention on oncology patients ' perceived level of distress . Each patient 's distress level was measured using 4 distinct dimensions : pain , physical discomfort , emotional discomfort , and fatigue . A total of 251 oncology patients volunteered to participate in this nonr and omized single-group pre- and post design study for over a 3-year period at a university hospital setting in southeastern Georgia . The analysis found a statistically significant reduction in patient-reported distress for all 4 measures : pain ( F = 638.208 , P = .000 ) , physical discomfort ( F = 742.575 , P = .000 ) , emotional discomfort ( F = 512.000 , P = .000 ) , and fatigue ( F = 597.976 , P = .000 ) . This reduction in patient distress was observed regardless of gender , age , ethnicity , or cancer type . These results lend support for the inclusion of a complementary massage therapy program for hospitalized oncology patients as a means of enhancing their course of treatment Research suggests that patients with cancer , particularly in the palliative care setting , are increasingly using aromatherapy and massage . There is good evidence that these therapies may be helpful for anxiety reduction for short periods , but few studies have looked at the longer term effects . This study was design ed to compare the effects of four-week courses of aromatherapy massage and massage alone on physical and psychological symptoms in patients with advanced cancer . Forty-two patients were r and omly allocated to receive weekly massages with lavender essential oil and an inert carrier oil ( aromatherapy group ) , an inert carrier oil only ( massage group ) or no intervention . Outcome measures included a Visual Analogue Scale ( VAS ) of pain intensity , the Verran and Snyder-Halpern ( VSH ) sleep scale , the Hospital Anxiety and Depression ( HAD ) scale and the Rotterdam Symptom Checklist ( RSCL ) . We were unable to demonstrate any significant long-term benefits of aromatherapy or massage in terms of improving pain control , anxiety or quality of life . However , sleep scores improved significantly in both the massage and the combined massage ( aromatherapy and massage ) groups . There were also statistically significant reductions in depression scores in the massage group . In this study of patients with advanced cancer , the addition of lavender essential oil did not appear to increase the beneficial effects of massage . Our results do suggest , however , that patients with high levels of psychological distress respond best to these therapies PURPOSE The aim of this feasibility study was to examine the use of reflexology lymphatic drainage ( RLD ) in the treatment of breast-cancer related lymphoedema ( BCRL ) with a view to further research . METHODS An uncontrolled trial was conducted with 26 women who had developed lymphoedema in one arm following treatment for breast cancer . Changes in upper-limb volumes and in participant concerns and wellbeing were measured . Qualitative data were also collected . RESULTS A significant reduction in the volume of the affected arm was identified at follow-up compared to baseline . This reduction in volume appeared to be maintained for more than six months . Participant concerns were significantly reduced and their wellbeing significantly increased . No serious adverse effects were reported . CONCLUSIONS RLD may be a useful intervention for BCRL although the results could not be attributed to the reflexology intervention because of research design limitations . The main conclusion was , however , that there was sufficient evidence for further research using a r and omized controlled trial Purpose Cancer patients frequently suffer from psychological comorbidities such as depression and elevated stress . Previous studies could demonstrate that cancer patients benefit from massage therapy on the physical and psychological level . This pilot study investigates the effects of massage on depression , mood , perceived stress , and the Th1/Th2 ratio in breast cancer patients . Methods Thirty-four breast cancer patients were r and omly assigned to a massage group ( n = 17 ) and a control group ( n = 17 ) . Patients of the massage group received two 30-min classical massages per week for 5 weeks . At baseline , at the end of the intervention period , and 6 weeks after the end of intervention , patients of both groups completed the Perceived Stress Question naire ( PSQ ) , the Patient Health Question naire ( PHQ ) , and the Berlin Mood Question naire ( BFS ) and blood was withdrawn for determining cytokine concentrations and the Th1/Th2 ratio . Results Twenty-nine patients were included in the statistical analysis . Depression ( PHQ ) and anxious depression ( BSF ) were significantly reduced immediately after massage compared to the control group . Stress ( PSQ ) and elevated mood ( BSF ) did not show significant alterations after massage therapy . Changes of cytokine concentrations and Th1/Th2 ratio were insignificant as well , although there was a slight shift towards Th1 in the massage group over time . Conclusions Massage therapy is an efficient treatment for reducing depression in breast cancer patients . Insignificant results concerning immunological parameters , stress , and mood indicate that further research is needed to determine psychological and immunological changes under massage therapy OBJECTIVES The aim of the present study was to examine the effect of massage on nausea , anxiety , and depression in patients with breast cancer undergoing chemotherapy . DESIGN This work was a single-center , prospect i ve , r and omized , controlled trial . SETTING S/LOCATION This study was conducted in an oncology clinic , in a hospital in southwestern Sweden . SUBJECTS Thirty-nine ( 39 ) women ( mean age = 51.8 ) with breast cancer undergoing chemotherapy were enrolled . INTERVENTIONS The patients were r and omly assigned to a massage therapy group ( 20 minutes of massage on five occasions ) or a control group ( five 20-minute visits ) . OUTCOME MEASURES All patients recorded nausea and anxiety on the Visual Analogue Scale before and after each intervention . They also completed the Hospital Anxiety and Depression \n Output:\n " }, { "from": "agent", "value": "Furthermore , this review demonstrated no differences in effects of massage on depression , mood disturbance , psychological distress , nausea , fatigue , physical symptom distress , or quality of life when compared with no massage .\nThere was some indication of benefit in the aromatherapy-massage group but this benefit is unlikely to translate into clinical benefit .\nMassage with aromatherapy versus massage without aromatherapy groupsFrom the limited evidence available , we were unable to assess the effect of adding aromatherapy to massage on the relief of pain , psychological symptoms including anxiety and depression , physical symptom distress , or quality of life .\nAUTHORS ' CONCLUSIONS There was a lack of evidence on the clinical effectiveness of massage for symptom relief in people with cancer ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Seeking screening and treatment for chlamydia ( CT ) and gonorrhea ( GC ) by young women is critical to reduction of asymptomatic cervicitis and its complications . OBJECTIVES To evaluate the efficacy of a client-centered motivational behavioral intervention ( MBI ) , to promote seeking of sexually tranmitted infection ( STI ) checkups by young women . METHODS Three hundred seventy-six of 770 eligible sexually active , nonpregnant , English-speaking women ( mean age 18.5 years ) were recruited from an urban reproductive health clinic and r and omized to two groups : intervention plus st and ard care ( MBI ) or st and ard care alone ( SC ) . MBI ( two sessions plus booster ) was based on the Transtheoretical Model of Change and employed motivational interviewing . Outcome measures monitored for 12 months included : client-initiated clinic visits for STI checkups in response to seven high-risk sexual behaviors by self-report ( primary ) , consistent condom use , number of CT and GC episodes , and movement along the stages of change obtained at baseline and 6- and 12-month follow-up assessment s ( secondary ) . Analyses included chi-square , logistic regression , and generalized estimating equations . RESULTS At baseline , more than 70 % endorsed the action stage of change for seeking STI checkups for three of seven high-risk sexual behaviors . No significant differences were noted between the two groups for the primary or secondary outcomes . Across groups , having multiple partners and being pregnant or thinking one might be pregnant were associated with STI checkups . CONCLUSIONS This is the first known client-centered clinical trial to promote STI screening . Risk-taking and health-seeking behaviors are complex and interrelated with STI and pregnancy concerns . The intervention may have an effect if it is targeted to women in a less medically connected community-based sample BACKGROUND The ability of specific behaviour-change interventions to reduce HIV infection in young people remains question able . Since January 1999 , an adolescent sexual and reproductive health ( SRH ) intervention has been implemented in ten r and omly chosen intervention communities in rural Tanzania , within a community r and omised trial ( see below ; NCT00248469 ) . The intervention consisted of teacher-led , peer-assisted in-school education , youth-friendly health services , community activities , and youth condom promotion and distribution . Process evaluation in 1999 - 2002 showed high intervention quality and coverage . A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 ( HSV-2 ) seroprevalence but found substantial improvements in SRH knowledge , reported attitudes , and some reported sexual behaviours . It was postulated that the impact on \" upstream \" knowledge , attitude , and reported behaviour outcomes seen at the 3-year follow-up would , in the longer term , lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes . A further impact evaluation survey in 2007/8 ( approximately 9 years post-intervention ) tested this hypothesis . METHODS AND FINDINGS This is a cross-sectional survey ( June 2007 through July 2008 ) of 13,814 young people aged 15 - 30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial ( 1999 - 2002 ) . Prevalences of the primary outcomes HIV and HSV-2 were 1.8 % and 25.9 % in males and 4.0 % and 41.4 % in females , respectively . The intervention did not significantly reduce risk of HIV ( males adjusted prevalence ratio [ aPR ] 0.91 , 95%CI 0.50 - 1.65 ; females aPR 1.07 , 95%CI 0.68 - 1.67 ) or HSV-2 ( males aPR 0.94 , 95%CI 0.77 - 1.15 ; females aPR 0.96 , 95%CI 0.87 - 1.06 ) . The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime ( aPR 0.87 , 95%CI 0.78 - 0.97 ) and an increase in reported condom use at last sex with a non-regular partner among females ( aPR 1.34 , 95%CI 1.07 - 1.69 ) . There was a clear and consistent beneficial impact on knowledge , but no significant impact on reported attitudes to sexual risk , reported pregnancies , or other reported sexual behaviours . The study population was likely to have been , on average , at lower risk of HIV and other sexually transmitted infections compared to other rural population s , as only youth who had reached year five of primary school were eligible . CONCLUSIONS SRH knowledge can be improved and retained long-term , but this intervention had only a limited effect on reported behaviour and no significant effect on HIV/STI prevalence . Youth interventions integrated within intensive , community-wide risk reduction programmes may be more successful and should be evaluated . TRIAL REGISTRATION Clinical Trials.gov CONTEXT Adolescent females often have questions or concerns about their contraceptive methods , and they may discontinue use if these questions are not answered . Little evidence exists on whether follow-up phone calls to address young women 's concerns can help sustain contraceptive use . METHODS Between 2005 and 2007 , a total of 805 females aged 14 - 18 attending a reproductive health clinic in San Francisco were r and omly assigned to receive either regular clinic services or regular clinic services plus nine follow-up phone calls over 12 months . The young women were surveyed at baseline and roughly six , 12 and 18 months later to measure condom and contraceptive use , rates of pregnancy and STDs , and other outcomes and mediators . Multiple linear and logistic regression repeated measures analyses were used to assess the program 's effects . RESULTS Clinic counselors completed only 2.7 calls per patient , and made 7.8 attempts for every completed call . Although contraceptive use increased from baseline to follow-up at six months in both groups , levels of condom and contraceptive use , and rates of pregnancy and STDs , did not differ between the intervention and control groups at any of the follow-up assessment s. Moreover , the intervention did not improve clinic utilization or satisfaction or have consistent positive effects on participants ' attitudes . CONCLUSIONS Reaching young women by phone after a clinic visit for contraception is challenging and does not appear to provide significant benefits beyond those provided by basic clinic services . More intensive interventions may be needed to markedly change adolescent sexual and contraceptive behavior OBJECTIVE To determine whether condom use among high-risk female adolescents could be increased by a behavioral intervention , with the use of infection with Chlamydia trachomatis as a biomarker of condom practice s. DESIGN Prospect i ve , r and omized , controlled intervention . SETTING Urban family planning and sexually transmitted disease clinics . PARTICIPANTS Two hundred nine female adolescents , aged 15 through 19 years , who were treated for C. trachomatis genitourinary infection , were r and omly assigned to st and ard ( control ) or experimental ( behavioral intervention ) groups . One hundred twelve subjects returned for follow-up 5 to 7 months after enrollment and comprise the study subjects . MEASUREMENTS Subjects completed a multiinstrument question naire measuring sexual behavior , condom practice s , attitudes and beliefs , cognitive complexity , sociodemographics , and motivation at enrollment and follow-up . Endourethral and endocervical sites were sample d for C. trachomatis . RESULTS Among the 112 subjects who returned for repeated examination , those who had received the experimental intervention reported increased use of condoms by their sexual partners for protection against sexually transmitted diseases ( odds ratio = 2.4 ; p = 0.02 ) and for vaginal intercourse ( odds ratio = 3.1 ; p = 0.005 ) at the 6-month follow-up . Multivariable logistic regression analysis controlling for condom use at enrollment demonstrated that the experimental intervention ( odds ratio = 2.8 ; p = 0.03 ) and the higher cognitive complexity ( odds ratio = 4.6 ; p = 0.02 ) independently contributed to greater condom use at follow-up . Despite greater use of condoms among the group who had received the intervention , use remained inconsistent and rates of reinfection with C. trachomatis were not significantly different ( 26 % vs 17 % ; p = 0.3 ) . CONCLUSION Although a brief behavioral intervention among high-risk female adolescents can increase condom use by their sexual partners , incident infection does not appear to be reduced , because condom use remained inconsistent PURPOSE To evaluate an intervention ( based on one which had previously been successful in reducing adolescent human immunodeficiency virus ( HIV ) risk behaviors in the United States ) among adolescents residing in Namibia , a country located in sub-Saharan Africa . METHODS A r and omized trial of a 14-session face-to-face intervention emphasizing abstinence and safer sex was conducted among 515 youth ( median age 17 years ; median grade 11 ) attending 10 secondary schools located in two districts in Namibia . Knowledge , attitudes , intentions , and HIV risk behaviors were assessed at baseline and in the immediate postintervention period . RESULTS Knowledge increased significantly among intervention compared to control youth ( 88 % vs. 82 % ; correct responses , p < .0001 ) . At postintervention follow-up , more intervention than control youth believed that they could be intimate without having sex , could have a girlfriend or boyfriend for a long time without having sex , could explain the process of impregnation , knew how to use a condom , and could ask for condoms in a clinic . Fewer intervention than control youth believed that if a girl refused to have sex with her boyfriend it was permissible for him to strike her , and that condoms took away a boy 's pleasure . More intervention than control youth anticipated using a condom when they did have sex , and fewer expected to drink alcohol . Finally , after intervention , there was a trend for increased condom use . There were significant gender-related differences at baseline , although intervention impact was generally equivalent . CONCLUSIONS These findings provide support for the judicious adaptation of successful Western HIV prevention programs in other cultural setting s. A single intervention approach appears to be effective in short-term follow-up with both genders BACKGROUND The American Academy of Pediatrics , the Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) , and the World Health Organization recommend that infants receive only breast milk or formula for the first 4 to 6 months of life , followed by the introduction of complementary foods . Despite these recommendations , many infants , particularly those with adolescent mothers , receive solid foods ( often cereal mixed with formula in a bottle ) and liquids other than formula or breast milk in the first few weeks of life . Decisions on early feeding are often guided by gr and mothers and influenced by beliefs that infants need complementary food to counteract signals of hunger , reduce crying , and sleep through the night . OBJECTIVE This investigation evaluated the efficacy of an intervention to delay the early introduction of complementary feeding among first-time , black , adolescent mothers living in multigenerational households . The intervention focused on reducing the cultural barriers to the acceptance of the recommendations of the American Academy of Pediatrics , WIC , and World Health Organization on complementary feeding by highlighting 3 topics : 1 ) recognition of infants ' cues ; 2 ) nonfood strategies for managing infant behavior ; and 3 ) mother-gr and mother negotiation strategies . The intervention was delivered through a mentorship model in which a videotape made by an advisory group of black adolescent mothers was incorporated into a home-visiting program and evaluated through a r and omized , controlled trial . METHODS One hundred eighty-one first-time , low-income , black mothers < 18 years old , living in multigenerational households were recruited from 3 urban hospitals . Infants were born at term , with birth weight appropriate for gestational age and no congenital problems . Shortly after delivery , mothers and gr and mothers completed a baseline assessment and mothers were r and omized into an intervention or control group . Intervention group mothers received home visitation every other week for 1 year . At 3 months , a subset of 121 adolescent mothers reported on their infant 's intake through a food frequency question naire . Mothers who fed their infant only breast milk , formula , or water were classified as optimal feeders . Mothers who provided complementary foods other than breast milk , formula , or water were classified as less optimal feeders . RESULTS Sixty-one percent of the infants received complementary foods before 3 months old . Multivariate hierarchical logistic regression was used to evaluate the determinants of being in the optimal versus less optimal feeders group . After controlling for infant age and family income , mothers of infants in the optimal feeders group were more likely to report accurate messages from WIC regarding the timing of complementary food and nearly 4 times more likely to be in the intervention group . The most common complementary food was cereal mixed with formula in the bottle . CONCLUSIONS The success of this relatively brief intervention demonstrates the importance of using ecological theory and ethnographic research to design interventions that enable participants to alter their behavior in the face of contradictory cultural norms . The intervention focused on interpreting infants ' cues , nonfood methods of managing infant behavior , and mother-gr and mother negotiations . It was delivered through methods that were familiar and acceptable to adolescent mothers-a mentorship model incorporating home visits and videotape . The skill-oriented aspects of the intervention delivered in a culturally sensitive context may have enabled the young mothers to follow the guidelines that they received from WIC and from their pediat \n Output:\n " }, { "from": "agent", "value": "The trials showed or reported no significant difference between study groups for pregnancy or HIV , but favorable effects were evident for some STI .\nWe found few studies and little clinical evidence of effectiveness for interventions promoting condom use for dual protection .\nWe did not find favorable results for pregnancy or HIV , and only found some for other STI .\nEffective interventions for improving condom use are needed to prevent pregnancy and HIV/STI transmission ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Summary Background We design ed the EURAMOS-1 trial to investigate whether intensified postoperative chemotherapy for patients whose tumour showed a poor response to preoperative chemotherapy ( ≥10 % viable tumour ) improved event-free survival in patients with high- grade osteosarcoma . Methods EURAMOS-1 was an open-label , international , phase 3 r and omised , controlled trial . Consenting patients with newly diagnosed , resectable , high- grade osteosarcoma aged 40 years or younger were eligible for r and omisation . Patients were r and omly assigned ( 1:1 ) to receive either postoperative cisplatin , doxorubicin , and methotrexate ( MAP ) or MAP plus ifosfamide and etoposide ( MAPIE ) using concealed permuted blocks with three stratification factors : trial group ; location of tumour ( proximal femur or proximal humerus vs other limb vs axial skeleton ) ; and presence of metastases ( no vs yes or possible ) . The MAP regimen consisted of cisplatin 120 mg/m2 , doxorubicin 37·5 mg/m2 per day on days 1 and 2 ( on weeks 1 and 6 ) followed 3 weeks later by high-dose methotrexate 12 g/m2 over 4 h. The MAPIE regimen consisted of MAP as a base regimen , with the addition of high-dose ifosfamide ( 14 g/m2 ) at 2·8 g/m2 per day with equidose mesna uroprotection , followed by etoposide 100 mg/m2 per day over 1 h on days 1–5 . The primary outcome measure was event-free survival measured in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT00134030 . Findings Between April 14 , 2005 , and June 30 , 2011 , 2260 patients were registered from 325 sites in 17 countries . 618 patients with poor response were r and omly assigned ; 310 to receive MAP and 308 to receive MAPIE . Median follow-up was 62·1 months ( IQR 46·6–76·6 ) ; 62·3 months ( IQR 46·9–77·1 ) for the MAP group and 61·1 months ( IQR 46·5–75·3 ) for the MAPIE group . 307 event-free survival events were reported ( 153 in the MAP group vs 154 in the MAPIE group ) . 193 deaths were reported ( 101 in the MAP group vs 92 in the MAPIE group ) . Event-free survival did not differ between treatment groups ( hazard ratio [ HR ] 0·98 [ 95 % CI 0·78–1·23 ] ) ; hazards were non-proportional ( p=0·0003 ) . The most common grade 3–4 adverse events were neutropenia ( 268 [ 89 % ] patients in MAP vs 268 [ 90 % ] in MAPIE ) , thrombocytopenia ( 231 [ 78 % in MAP vs 248 [ 83 % ] in MAPIE ) , and febrile neutropenia without documented infection ( 149 [ 50 % ] in MAP vs 217 [ 73 % ] in MAPIE ) . MAPIE was associated with more frequent grade 4 non-haematological toxicity than MAP ( 35 [ 12 % ] of 301 in the MAP group vs 71 [ 24 % ] of 298 in the MAPIE group ) . Two patients died during postoperative therapy , one from infection ( although their absolute neutrophil count was normal ) , which was definitely related to their MAP treatment ( specifically doxorubicin and cisplatin ) , and one from left ventricular systolic dysfunction , which was probably related to MAPIE treatment ( specifically doxorubicin ) . One suspected unexpected serious adverse reaction was reported in the MAP group : bone marrow infa rct ion due to methotrexate . Interpretation EURAMOS-1 results do not support the addition of ifosfamide and etoposide to postoperative chemotherapy in patients with poorly responding osteosarcoma because its administration was associated with increased toxicity without improving event-free survival . The results define st and ard of care for this population . New strategies are required to improve outcomes in this setting . Funding UK Medical Research Council , National Cancer Institute , European Science Foundation , St Anna Kinderkrebsforschung , Fonds National de la Recherche Scientifique , Fonds voor Wetenschappelijk Onderzoek-Vla and eren , Parents Organization , Danish Medical Research Council , Academy of Finl and , Deutsche Forschungsgemeinschaft , Deutsche Krebshilfe , Federal Ministry of Education and Research , Semmelweis Foundation , ZonMw ( Council for Medical Research ) , Research Council of Norway , Sc and inavian Sarcoma Group , Swiss Paediatric Oncology Group , Cancer Research UK , National Institute for Health Research , University College London Hospitals , and Biomedical Research Centre The case histories of all patients with osteosarcoma of the trunk entered into the consecutive studies COSS 80 through COSS 86 of the Cooperative German/Austrian Osteosarcoma Study Group ( COSS ) were analyzed in order to evaluate their clinical characteristics and the impact of modern neoadjuvant therapy on prognosis . They were compared to those of all patients with extremity osteosarcoma treated according to the same protocol s. While tumors of the trunk comprised only 32 ( 4.8 % ) of 665 primary classical osteosarcomas , secondary osteosarcomas were much more likely to be located in bones of the axial skeleton ( 6 of 18 , 33 % ) . Patients with primary osteosarcoma of the axial skeleton were older ( mean : 20.8 vs. 15.2 years , P < 0.01 ) and were more likely to present with metastases at diagnosis ( 34 % vs 12 % , P < 0.001 ) than those with primary extremity osteosarcoma . In contrast to extremity tumors , local surgical treatment failure was very common in osteosarcomas of the trunk . Complete tumor removal was achieved in less than half of all evaluable cases . The prognosis of eight patients with localized primary axial osteosarcoma and effective surgical local control was not inferior to that of 483 equally evaluable patients with extremity tumors . In conclusion , while secondary systemic spread of axial osteosarcoma may be avoided in patients treated with multiagent chemotherapy , successful treatment is often barred by primary metastatic disease and inability to control the local tumor site PURPOSE To determine whether the addition of ifosfamide and /or muramyl tripeptide ( MTP ) encapsulated in liposomes to cisplatin , doxorubicin , and high-dose methotrexate ( HDMTX ) could improve the probability for event-free survival ( EFS ) in newly diagnosed patients with osteosarcoma ( OS ) . PATIENTS AND METHODS Six hundred seventy-seven patients with OS without clinical ly detectable metastatic disease were treated with one of four prospect ively r and omized treatments . All patients received identical cumulative doses of cisplatin , doxorubicin , and HDMTX and underwent definitive surgical resection of the primary tumor . Patients were r and omly assigned to receive or not to receive ifosfamide and /or MTP in a 2 double dagger 2 factorial design . The primary end point for analysis was EFS . RESULTS Patients treated with the st and ard arm of therapy had a 3-year EFS of 71 % . We could not analyze the results by factorial design because we observed an interaction between the addition of ifosfamide and the addition of MTP . The addition of MTP to st and ard chemotherapy achieved a 3-year EFS rate of 68 % . The addition of ifosfamide to st and ard chemotherapy achieved a 3-year EFS rate of 61 % . The addition of both ifosfamide and MTP result ed in a 3-year EFS rate of 78 % . CONCLUSION The addition of ifosfamide in this dose schedule to st and ard chemotherapy did not enhance EFS . The addition of MTP to chemotherapy might improve EFS , but additional clinical and laboratory investigation will be necessary to explain the interaction between ifosfamide and MTP We conducted a r and omized controlled trial to determine whether intensive multi-agent adjuvant chemotherapy improves the chances of relapse-free survival in patients with nonmetastatic high- grade osteosarcoma of the extremity , as compared with concurrent controls . After undergoing definitive surgery , 36 patients were r and omly assigned to adjuvant chemotherapy or to observation without adjuvant treatment . At two years the actuarial relapse-free survival was 17 percent in the control group , similar to that found in studies before 1970 , and 66 percent in the adjuvant-chemotherapy group ( P less than 0.001 ) . Similar results were observed among 77 additional patients who declined to undergo r and omization but who elected observation or chemotherapy . We conclude that the natural history of osteosarcoma of the extremity has remained stable over the past two decades , that adjuvant chemotherapy increases the chances of relapse-free survival of patients with high- grade osteosarcoma , and that it should be given to all such patients PURPOSE To define prognostic factors for response and long-term outcome for a wide spectrum of osteosarcomas , extending well beyond those of the typical young patient with seemingly localized extremity disease . PATIENTS AND METHODS A total of 1,702 consecutive newly diagnosed patients with high- grade osteosarcoma of the trunk or limbs registered into the neoadjuvant studies of the Cooperative Osteosarcoma Study Group before July 1998 were entered into an analysis of demographic , tumor-related , and treatment-related variables , response , and survival . The intended therapeutic strategy included preoperative and postoperative chemotherapy with multiple agents as well as surgery of all operable lesions . RESULTS Axial tumor site , male sex , and a long history of symptoms were associated with poor response to chemotherapy in univariate and multivariate analysis . Actuarial 10-year overall and event-free survival rates were 59.8 % and 48.9 % . Among the variables assessable at diagnosis , patient age ( actuarial 10-year survival > or = 40 , 41.6 % ; < 40 , 60.2 % ; P = .012 ) , tumor site ( axial , 29.2 % ; limb , 61.7 % ; P < .0001 ) , and primary metastases ( yes , 26.7 % ; no , 64.4 % ; P < .0001 ) , and for extremity osteosarcomas , also size ( > or = one third , 52.5 % ; < one third , 66.7 % ; P < .0001 ) and location within the limb ( proximal , 49.3 % ; other , 63.9 % ; P < .0001 ) , had significant influence on outcome . Two additional important prognostic factors were treatment related : response to chemotherapy ( poor , 47.2 % ; good , 73.4 % ; P < .0001 ) and the extent of surgery ( incomplete , 14.6 % ; macroscopically complete , 64.8 % ; P < .0001 ) . All factors except age maintained their significance in multivariate testing , with surgical remission and histologic response emerging as the key prognostic factors . CONCLUSION Tumor site and size , primary metastases , response to chemotherapy , and surgical remission are of independent prognostic value in osteosarcoma Background High- grade osteosarcoma is a primary malignant bone tumour mainly affecting children and young adults . The European and American Osteosarcoma Study (EURAMOS)-1 is a collaboration of four study groups aim ing to improve outcomes of this rare disease by facilitating r and omised controlled trials . Methods Patients eligible for EURAMOS-1 were aged ≤40 years with M0 or M1 skeletal high- grade osteosarcoma in which case complete surgical resection at all sites was deemed to be possible . A three-drug combination with methotrexate , doxorubicin and cisplatin was defined as st and ard chemotherapy , and between April 2005 and June 2011 , 2260 patients were registered . We report survival outcomes and prognostic factors in the full cohort of registered patients . Results For all registered patients at a median follow-up of 54 months ( interquartile range : 38–73 ) from biopsy , 3-year and 5-year event-free survival were 59 % ( 95 % confidence interval [ CI ] : 57–61 % ) and 54 % ( 95 % CI : 52–56 % ) , respectively . Multivariate analyses showed that the most adverse factors at diagnosis were pulmonary metastases ( hazard ratio [ HR ] = 2.34 , 95 % CI : 1.95–2.81 ) , non-pulmonary metastases ( HR = 1.94 , 95 % CI : 1.38–2.73 ) or an axial skeleton tumour site ( HR = 1.53 , 95 % CI : 1.10–2.13 ) . The histological subtypes telangiectatic ( HR \n Output:\n " }, { "from": "agent", "value": "Age , tumor location , tumor size/volume , and histologic response carried independent prognostic value in the majority of the studies ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The behavioral processes of weight reduction are poorly understood , and responses to treatments based primarily on caloric restriction have been unfavorable . A theory-based path derived from proposed relations of physical activity , changes in psychological factors , and weight loss was separately tested with women with Class I and Class II obesity ( body mass index [ BMI ] from 30 to 39.9 kg/m2 ; n = 116 ) , and Class III ( BMI ≥ 40.0 kg/m2 ; n = 57 ) obesity . Participation in a cognitive-behavioral exercise support treatment along with nutrition education was significantly associated with changes in measures of self-efficacy , body satisfaction , and mood . Changes did not significantly differ by BMI group . Multiple regression analyses indicated that changes in the psychological factors explained 14 % ( Class I/II obesity group ) and 22 % ( Class III obesity group ) of the variance in exercise session attendance , and attendance was strongly related to weight loss . Implication s for weight loss theory and treatment are discussed Background Despite a growing literature on the efficacy of behavioral weight loss interventions , we still know relatively little about the long terms effects they have on HRQL . Therefore , we conducted a study to investigate the immediate post-intervention ( 6 months ) and long-term ( 12 and 24 months ) effects of clinical ly based weight management programs on HRQL . Methods We conducted a r and omized clinical trial in which all participants completed a 6 month clinical weight loss program and were r and omized into two 6-month extended care groups . Participants then returned at 12 and 24 months for follow-up assessment s. A total of 144 individuals ( 78 % women , M age = 50.2 ( 9.2 ) yrs , M BMI = 32.5 ( 3.8 ) kg/m2 ) completed the 6 month intervention and 104 returned at 24 months . Primary outcomes of weight and HRQL using the SF-36 were analyzed using multivariate repeated measures analyses . Results There was complete data on 91 participants through the 24 months of the study . At baseline the participants scored lower than U.S. age-specific population norms for bodily pain , vitality , and mental health . At the completion of the 6 month clinical intervention there were increases in the physical and mental composite measures as well as physical functioning , general health , vitality , and mental health subscales of the SF-36 . Despite some weight regain , the improvements in the mental composite scale as well as the physical functioning , vitality , and mental health subscales were maintained at 24 months . There were no significant main effects or interactions by extended care treatment group or weight loss group ( whether or not they maintained 5 % loss at 24 months ) . Conclusion A clinical weight management program focused on behavior change was successful in improving several factors of HRQL at the completion of the program and many of those improvements were maintained at 24 months . Maintaining a significant weight loss ( > 5 % ) was not necessary to have and maintain improvements in HRQL Background Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventing unhealthy weight gain and chronic diseases than intervening on a single behavior , few studies have compared individual and combined effects of diet and /or exercise interventions on health-related quality of life ( HRQOL ) . In addition , the mechanisms of how these lifestyle interventions affect HRQOL are unknown . The primary aim of this study was to examine the individual and combined effects of dietary weight loss and /or exercise interventions on HRQOL and psychosocial factors ( depression , anxiety , stress , social support ) . The secondary aim was to investigate predictors of changes in HRQOL . Methods This study was a r and omized controlled trial . Overweight/obese postmenopausal women were r and omly assigned to 12 months of dietary weight loss ( n = 118 ) , moderate-to-vigorous aerobic exercise ( 225 minutes/week , n = 117 ) , combined diet and exercise ( n = 117 ) , or control ( n = 87 ) . Demographic , health and anthropometric information , aerobic fitness , HRQOL ( SF-36 ) , stress ( Perceived Stress Scale ) , depression [ Brief Symptom Inventory (BSI)-18 ] , anxiety ( BSI-18 ) and social support ( Medical Outcome Study Social Support Survey ) were assessed at baseline and 12 months . The 12-month changes in HRQOL and psychosocial factors were compared using analysis of covariance , adjusting for baseline scores . Multiple regression was used to assess predictors of changes in HRQOL . Results Twelve-month changes in HRQOL and psychosocial factors differed by intervention group . The combined diet + exercise group improved 4 aspects of HRQOL ( physical functioning , role-physical , vitality , and mental health ) , and stress ( p ≤ 0.01 vs. controls ) . The diet group increased vitality score ( p < 0.01 vs. control ) , while HRQOL did not change differently in the exercise group compared with controls . However , regardless of intervention group , weight loss predicted increased physical functioning , role-physical , vitality , and mental health , while increased aerobic fitness predicted improved physical functioning . Positive changes in depression , stress , and social support were independently associated with increased HRQOL , after adjusting for changes in weight and aerobic fitness . Conclusions A combined diet and exercise intervention has positive effects on HRQOL and psychological health , which may be greater than that from exercise or diet alone . Improvements in weight , aerobic fitness and psychosocial factors may mediate intervention effects on HRQOL.Trial Registration Clinical Trials , Clinical Trials.gov register , To examine the effect of treatment-induced weight loss on Health-Related Quality of Life ( HRQL ) , 38 mildly-to-moderately overweight persons recruited to participate in a study to examine the efficacy of a lifestyle modification treatment program completed a sociodemographic question naire , the Beck Depression Inventory ( BDI ) , the Medical Outcomes Study Short-Form Health Survey ( SF-36 , as an assessment of HRQL ) , and underwent a series of clinical evaluations prior to treatment . After baseline evaluations , participants were r and omly assigned to either a program of lifestyle physical activity or a program of traditional aerobic activity . Participants again completed the SF-36 and BDI after the 13-week treatment program had ended . Weight loss averaged 8.6 ± 2.8 kg over the 13-week study . We found that weight loss was associated with significantly higher scores ( enhanced HRQL ) , relative to baseline , on the physical functioning , role-physical , general health , vitality and mental health domains of the SF-36 . The largest improvements were with respect to the vitality , general health perception and role-physical domains . There were no significant differences between the lifestyle and aerobic activity groups on any of the study measures . These data indicate that , at least in the short-term , weight loss appears to profoundly enhance HRQL Abstract The aim of this study was to examine the effects of the addition of a resistance training programme to a caloric restriction weight loss intervention on psychosocial profile . The study sample consisted of 137 overweight and obese post-menopausal women . Participants were r and omized to a caloric restriction group and caloric restriction + resistance training group . Psychosocial , anthropometric , and metabolic variables were measured before and after the 6-month weight loss intervention . Both groups presented similar weight loss and there were no significant differences between the caloric restriction group and caloric restriction + resistance training group for changes in psychosocial profile . Thereafter , all participants were classified into quintiles based on the amount of weight loss . In all quintiles , women markedly improved body esteem and self-esteem , and decreased hunger and perceived risk for diabetes mellitus ( P < 0.05 ) . However , significant increases in dietary restraint were observed in quintiles 2–5 ( ≥2.4 % body weight loss ) , decreases in disinhibition in quintiles 3–5 ( ≥4.9 % ) , increases in self-efficacy in quintiles 3–5 ( ≥4.9 % ) , and increases in health perceptions in quintile 5 ( ≥11.1 % ) . The results of this study do not support the hypothesis that the addition of a resistance training programme to a caloric restriction weight loss intervention has additional benefits on psychosocial profile . Overall , the significant improvements in the psychosocial profile observed were mostly accounted for by the degree of weight loss Weight loss improves health-related quality of life ( HRQoL ) . However , regain after loss is common ; little is known about the impact of weight regain on HRQoL in postmenopausal women . Woman on the Move through Activity and Nutrition ( WOMAN ) is a r and omized lifestyle intervention trial of diet , physical activity , and weight loss in 508 postmenopausal women aged 52 - 62 years . This analysis focused on the women who lost > or = 5 lb during the initial phase of the study , baseline to 6 months ( n = 248 ) . This cohort was divided into three groups based on subsequent weight change between 6 and 18 months : weight loss ( WL ; > or = 5 lb loss ) , weight stable ( WS ; < + /-5 lb change ) , and weight regain ( WR ; > or = 5 lb gain ) . HRQoL was measured at baseline , 6 , and 18 months using the Short Form-36 . Of the 248 women studied , 51 ( 21 % ) continued to lose weight after initial weight loss , while 127 ( 51 % ) maintained a stable weight , and 70 ( 28 % ) regained weight . Between baseline and 6 months , women in WR group had decreased mental health and social-functioning scores , while the WL and WS groups improved in these subscales . Between baseline and 18 months , energy improved most significantly in those with continued weight loss ( P = 0.0003 ) . Weight loss was correlated with a small to moderate improvement in perceived general health and energy , which was reversed by weight gain . Further study is needed to investigate the impact of a decline in mental health and social functioning on future weight regain Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials . Design Trial protocol s were compared with subsequent publication(s ) to identify any discrepancies in the outcomes reported , and telephone interviews were conducted with the respective trialists to investigate more extensively the reporting of the research and the issue of unreported outcomes . Participants Chief investigators , or lead or co authors of trials , were identified from two sources : trials published since 2002 covered in Cochrane systematic review s where at least one trial analysed was suspected of being at risk of outcome reporting bias ( issue 4 , 2006 ; issue 1 , 2007 , and issue 2 , 2007 of the Cochrane library ) ; and a r and om sample of trial reports indexed on PubMed between August 2007 and July 2008 . Setting Australia , Canada , Germany , the Netherl and s , New Zeal and , the United Kingdom , and the United States . Main outcome measures Frequency of incomplete outcome reporting — signified by outcomes that were specified in a trial ’s protocol but not fully reported in subsequent publications— and trialists ’ reasons for incomplete reporting of outcomes . Results 268 trials were identified for inclusion ( 183 from the cohort of Cochrane systematic review s and 85 from PubMed ) . Initially , 161 respective investigators responded to our requests for interview , 130 ( 81 % ) of whom agreed to be interviewed . However , failure to achieve subsequent contact , obtain a copy of the study protocol , or both meant that final interviews were conducted with 59 ( 37 % ) of the 161 trialists . Sixteen trial investigators failed to report analysed outcomes at the time of the primary publication , 17 trialists collected outcome data that were subsequently not analysed , and five trialists did not measure a prespecified outcome over the course of the trial . In almost all trials in which prespecified outcomes had been analysed but not reported ( 15/16 , 94 % ) , this under-reporting result ed in bias . In nearly a quarter of trials in which prespecified outcomes had been measured but not analysed ( 4/17 , 24 % ) , the “ direction ” of the main findings influenced the investigators ’ decision not to analyse the remaining data collected . In 14 ( 67 % ) of the 21 r and omly selected PubMed trials , there was at least one unreported efficacy or harm outcome . More than a quarter ( 6/21 , 29 % ) of these trials were found to have displayed outcome reporting bias . Conclusion The prevalence of incomplete outcome reporting is high . Trialists seemed generally unaware of the implication s for the evidence base of not reporting all outcomes and protocol changes . A general lack of consensus regarding the choice of outcomes in particular clinical setting s was evident and affects trial design , conduct , analysis , and reporting Long-term behavioral self-regulation is the hallmark of successful weight control . We tested mediators of weight loss and weight loss maintenance in middle-aged women who participated in a r and omized controlled 12-month weight management intervention . Overweight and obese women ( N = 225 , BMI = 31.3 + /- 4.1 kg/m(2 ) ) were r and omly assigned to a control or a 1-year group intervention design ed to promote autonomous self-regulation of body weight . Key exercise , eating behavior , and body image variables were assessed before and after the program , and tested as mediators of weight loss ( 12 months , 86 % retention ) and weight loss maintenance ( 24 months , 81 % retention ) . Multiple mediation was employed and an intention-to-treat analysis conducted . Treatment effects were observed for all putative mediators ( Effect size : 0.32 - 0.79 , P < 0.01 vs. controls ) . Weight change was -7.3 + /- 5.9 % ( 12-month ) and -5.5 + /- 5 \n Output:\n " }, { "from": "agent", "value": "The results demonstrated consistent improvements in psychological outcomes concurrent with and sometimes without weight loss .\nImprovements in body image and HRQoL ( especially vitality ) were closely related to changes in weight ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Evidence suggests that ingesting lactic acid bacteria exerts a suppressive effect on Helicobacter pylori infection in both animals and humans . Supplementing with Lactobacillus- and Bifidobacterium-containing yogurt ( AB-yogurt ) was shown to improve the rates of eradication of H. pylori in humans . OBJECTIVE We administered AB-yogurt to subjects with asymptomatic H. pylori to test whether the yogurt could inhibit H. pylori growth . DESIGN The in vitro inhibition of H. pylori growth was determined by inoculating Lactobacillus acidophilus La5 or Bifidobacterium lactis Bb12 on plates that were inoculated with H. pylori . Assessment of the viability of H. pylori was performed by the mixed culture method with La5 or Bb12 . In an intervention study , 59 adult volunteers infected with H. pylori were given AB-yogurt ( 10(7 ) colony-forming units of both La5 and Bb12/mL ) twice daily after a meal for 6 wk . Eleven subjects positive for H. pylori infection were treated with milk placebo as control subjects . H. pylori bacterial loads were determined with use of the (13)C-urea breath test , which was performed before and 4 and 8 wk after the start of AB-yogurt supplementation . RESULTS Bb12 exerted an in vitro inhibitory effect against H. pylori , whereas La5 did not show an effect . Administration of AB-yogurt decreased the urease activity of H. pylori after 6 wk of therapy ( P < 0.0001 ) . CONCLUSION Regular intake of yogurt containing Bb12 and La5 effectively suppressed H. pylori infection in humans Probiotics have proven to be useful in the treatment of a number of gastrointestinal diseases . Probiotics may compete directly with Helicobacterpylori , possibly by interference with adherence or by the production of antimicrobial molecules . Lactobacillusreuteri has been shown to inhibit H. pylori in vitro and in vivo , and theoretically may play a role in eradication therapy . The aim of this study was to examine the efficacy of L. reuteri in H. pylori eradication therapy . This was an open label single center study . H. pylori infection was defined as positive gastric histopathology and 13C-UBT . Intervention consisted of L. reuteri ( DSM 17938 ) 108 cfu plus pantoprazole 20 mg twice a day for 8 weeks . Eradication was defined as a negative 13C-UBT , 4–6 weeks post therapy . Compliance was considered good if at least 90 % of the total number of the pills were taken . 21 of 22 subjects completed the study without protocol violation ( mean age 52 years ; 36 % men ) . L. reuteri plus pantoprazole twice a day cured 13.6 % ( 3/22 ; 95 % CI 2.9–34.9 % ) of patients with H. pylori infection by ITT analysis and 14.2 % ( 3/21 ; 95 % CI 3.0–36 % ) by PP analysis . Overall urease activity assessed before and 4–6 weeks post therapy showed a significant reduction with a difference of mean of 38.8 vs. 25.4 by one-tailed test ( P = 0.002 ) . In conclusion , L. reuteri may have a potential role in H. pylori eradication therapy if the cure rate can be improved by changes in dose , dosing interval , or duration of therapy Background : Helicobacter pylori infects around 50 % of the human population and is asymptomatic in 70 % of the cases . H. pylori eradication in childhood will not only result in peptic symptoms relief , but will also prevent late-term complications such as cancer . Today , probiotics are being increasingly studied in the treatment of gastrointestinal infections as an alternative or complement to antibiotics . Objectives : In this study we aim ed to assess the effect of S. boulardii supplementation on H. pylori eradication among children in our region . Patients and Methods : In this r and omized double-blind placebo-controlled clinical trial 28 asymptomatic primary school children with a positive H. pylori stool antigen ( HpSA ) exam were r and omly allocated into the study group , receiving Saccharomyces boulardii , and the control group receiving placebo capsules matched by shape and size , for one month . The children were followed up weekly and were reinvestigated four to eight weeks after accomplished treatment by HpSA testing . The significance level was set at P < 0.05 . Results : 24 children completed the study . The mean HpSA reduced from 0.40 ± 0.32 to 0.21 ± 0.27 in the study group , indicating a significant difference ( P = 0.005 ) . However , such difference was not observed in the control group ( P = 0.89 ) . Moreover , the HpSA titer showed a 0.019 ± 0.19 decrease in the study group whereas the same value was 0.0048 ± 0.12 for the controls , again stating a significant difference ( P = 0.01 ) . Conclusions : Saccharomyces boulardii has a positive effect on reducing the colonization of H. pylori in the human gastrointestinal system but is not capable of its eradication when used as single therapy Abstract Reducing the amount of Helicobacter pylori in the stomach by selective bacterial – bacterial cell interaction was sought as an effective and novel method for combating the stomach pathogen . Lactobacillus reuteri DSM17648 was identified as a highly specific binding antagonist to H. pylori among more than 700 wild-type strains of Lactobacillus species . Applying a stringent screening procedure , the strain DSM17648 was identified as selective binder to H. pylori cells under in vivo gastric conditions . The strain DSM17648 co-aggregates the pathogen in vivo and in vitro . The specific co-aggregation occurs between Lact . reuteri DSM17648 and different H. pylori strains and serotypes , as well as H. heilmannii , but not with Campylobacter jejuni or other commensal oral and intestinal bacteria . Lact . reuteri DSM17648 was shown in a proof-of-concept single-blinded , r and omized , placebo-controlled pilot study to significantly reduce the load of H. pylori in healthy yet infected adults . Reducing the amount of H. pylori in the stomach by selective bacterial – bacterial cell interaction might be an effective and novel method for combating the stomach pathogen . Lact . reuteri DSM17648 might prove useful as an adhesion blocker in antibiotic-free H. pylori therapies To examine the efficacy of Lactobacillus gasseri OLL2716 ( LG21 ) as a probiotic for Helicobacter pylori in humans , 31 subjects infected with the bacterium ingested yogurt containing LG21 daily for an 8 week period . The [(13)C]urea breath test and assays of serum pepsinogens revealed a significant improvement following LG21 treatment . LG21 was thus determined to be effective in both suppressing H. pylori and reducing gastric mucosal inflammation Background : Lactobacillus johnsonii ( Lj1 ) had an in vitro and in vivo inhibitory effect on Helicobacter pylori . Fermented milk containing Lj1 ( LC1 ) , coadministered with antibiotics had a favourable effect on H. pylori gastritis BACKGROUND The role of probiotics in the armamentarium remains to be defined . The aims of this study were to investigate whether the long-time administration of Lactobacillus gasseri OLL2716 ( LG21 ) strain can eradicate H. pylori in asymptomatic pre-school children and /or prevent H. pylori infection . METHODS A total of 440 children , from 5 - 7 years of age , attending a kindergarten in Thail and were screened by the Helicobacter pylori stool antigen ( HpSA ) test . Thereafter 132 H. pylori positive and 308 H. pylori negative children were recruited to eradication and r and omized prevention arms , respectively . Children in the active and placebo treatment groups received Lactobacillus gasseri OLL2716 ( LG21 ) containing cheese and ordinary cheese , respectively , for 12 months . Eradication was defined as reversion by HpSA at 12 months . Prevention was defined as persistently HpSA negative at 12 months . RESULTS Eighty-two of 132 H. pylori positive ( 62 % ) completed the eradication arm , of which 24 ( 29.3 % ) were negative at 12 months according to the HpSA test . In the r and omized prevention arm , 123 of 156 ( 79 % ) and 99 of 122 ( 81 % ) completed active and placebo arms , respectively , of which 4.1 % and 8.1 % , respectively , were HpSA positive at 12 months based on a per- protocol analysis ( p = .21 ) . CONCLUSION Further trials are needed Goals : The goals of this study were to investigate the role of a new probiotic preparation ( Lactobacillus reuteri DSM 17938 and L. reuteri ATCC PTA 6475 ) in Helicobacter pylori infection . Background : Specific probiotic strains play a role in H. pylori infection for their ability to decrease bacterial load and gastritis , prevent antibiotic-associated side effects , and increase the eradication rate . Study : This is a prospect i ve , double-blind , r and omized , placebo-controlled study in a tertiary care setting . A total of 100 H. pylori – positive naive patients received either L. reuteri combination ( 2 × 108 Colony Forming Units ) or placebo during a 3-phase study ( pre-eradication , eradication , and follow-up ) . All underwent 13C urea breath test ( 13C-UBT ) , blood assessment s of gastrin-17 ( G17 ) , endoscopy , and the Gastrointestinal Symptom Rating Scale . Eradication was confirmed by 13C-UBT 8 weeks after the completion of therapy . Results : Fifty patients were allocated in each group . During pre-eradication period , 13C-UBT & dgr ; decreased by 13 % in L. reuteri combination as compared with a 4 % increase in placebo ( −13.2±34 % vs. 4.3±27 % ; P<0.03 ) . During eradication , GSRS increased significantly in placebo as compared with L. reuteri combination ( 6.8±2.9 vs. 4±3.1 ; P<0.01 ) . Significantly less patients in L. reuteri combination as compared with placebo-reported side effects ( 40.9 % vs. 62.8 % ; P<0.04 ) . An abnormal G17 value was found in patients receiving placebo as compared with L. reuteri combination ( 28 % vs. 12 % ; P<0.02 ) . Eradication rate was 75 % in L. reuteri combination and 65.9 % in placebo ( P = NS ) . L. reuteri combination increased eradication rate by 9.1 % ( odds ratio : 1.5 ) . Conclusions : L. reuteri combination alone is able to exert an inhibitory effect on H. pylori growth , and when administered with eradication therapy , it determines a significant reduction in antibiotic-associated side effects . Moreover , L. reuteri combination was able to decrease serum G17 levels and to ( not significantly ) increase the H. pylori – eradication rate BACKGROUND Functional probiotics may prevent Helicobacter pylori infection , and some evidence suggests that they also possess antitumor properties . Lactobacillus brevis ( CD2 ) is a functional Lactobacillus strain with peculiar biochemical features , essentially related to the activity of arginine deiminase . This enzyme catalyzes the catabolism of arginine and affects the bio synthesis of polyamines ( putrescine , spermidine , and spermine ) . Polyamines are polycations found in high concentrations in both normal and neoplastic cells . Our aims were : 1 , to assess whether oral administration of L. brevis ( CD2 ) affects H. pylori survival in the human gastric mucosa ; 2 , to evaluate the effects of L. brevis ( CD2 ) on polyamine bio synthesis in gastric biopsies from H. pylori-positive patients . MATERIAL S AND METHODS For 3 weeks before endoscopy , 22 H. pylori-positive dyspeptic patients r and omly received ( ratio 1 : 1 ) high oral doses of L. brevis ( CD2 ) or placebo . Before and after treatment , H. pylori infection was determined by urea breath test ( UBT ) . In gastric biopsies , ornithine decarboxylase activity and polyamine levels were , respectively , evaluated by a radiometric technique and high-pressure liquid chromatography ( H \n Output:\n " }, { "from": "agent", "value": "Probiotics alone show a minimal effect on H. pylori clearance , thus suggesting a likely direct role" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background — Experimental studies suggest that deferoxamine ( DFO ) limits the generation of reactive oxygen species by chelating redox-active iron and thereby may reduce ischemia-reperfusion injury and myocardial infa rct ( MI ) size . We investigated whether DFO administered before reperfusion by primary percutaneous coronary intervention ( PPCI ) would ameliorate oxidative stress and MI size . Methods and Results — We r and omly assigned 60 patients with ST-elevation – MI to receive an intravenous bolus of DFO ( 500 mg ) immediately before PPCI followed by a 12-hour infusion ( 50 mg/kg of body weight ) ( n=28 ) or normal saline bolus and infusion ( placebo group , n=32 ) . MI size was measured by contrast-enhanced cardiac MRI ( CMRI ; day 3±1 ) , creatine kinase and troponin I area-under-the-curve , and severity of wall motion abnormality on echocardiography . Clinical follow-up including repeat CMRI and echocardiography were performed at 3 months ( 100±17 days ) . Oxidative stress was assessed by plasma F2-isoprostane levels . DFO and placebo groups were well balanced with respect to baseline characteristics , symptom- and door-to-balloon times , pre-PPCI coronary patency , and infa rct -related artery location . Serum iron levels were decreased with DFO treatment after PPCI compared with placebo ( 3.0±2.5 versus 12.6±5.5 & mgr;mol/L , P<0.0001 ) , which persisted until the end of the infusion . In DFO-treated patients , there was a significant reduction in plasma F2-isoprostane levels immediately after PPCI ( 2878±1461 versus 2213±579 pmol/L , P=0.04 ) . However , there was no difference in CMRI-determined infa rct size ( DFO , 17.4±10.8 % , versus placebo , 18.6±10.2 % ; P=0.73 ) , myocardial salvage index at 3 days or at 3 months , or the area-under-the-curve for creatine kinase or troponin I. Conclusions — Adjunctive DFO treatment after the onset of ischemia and continued periprocedurally ameliorates oxidative stress without limiting infa rct size . Clinical Trial Registration — URL : http://www.anzctr.org.au/. Unique identifier : ACTRN12608000308392 OBJECTIVES The aim of this r and omized , single-blind , controlled trial was to assess N-acetylcysteine effects on contrast-induced nephropathy and reperfusion injury in ST-segment elevation myocardial infa rct ion patients undergoing primary angioplasty with moderate contrast volumes . BACKGROUND High-dose N-acetylcysteine reduced the incidence of contrast-induced nephropathy in patients with high contrast volumes and reduced reperfusion injury in animal trials . METHODS Patients undergoing primary angioplasty were r and omized to either high-dose N-acetylcysteine ( 2 x 1,200 mg/day for 48 h ; n = 126 ) or placebo plus optimal hydration ( n = 125 ) . The 2 primary end points were : 1 ) the occurrence of > 25 % increase in serum creatinine level < 72 h after r and omization ; and 2 ) a reduction in reperfusion injury measured as myocardial salvage index by magnetic resonance imaging . RESULTS The median volume of an iso-osmolar contrast agent during angiography was 180 ml ( interquartile range [ IQR ] 140 to 230 ml ) in the N-acetylcysteine and 160 ml ( IQR 120 to 220 ml ) in the placebo group ( p = 0.20 ) . The primary end point contrast-induced nephropathy occurred in 14 % of the N-acetylcysteine group and in 20 % of the placebo group ( p = 0.28 ) . The myocardial salvage index was also not different between both treatment groups ( 43.5 ; IQR 25.4 to 71.9 vs. 51.5 ; IQR 29.5 to 75.3 ; p = 0.36 ) . Activated oxygen protein products and oxidized low-density lipoprotein as markers for oxidative stress were reduced by as much as 20 % in the N-acetylcysteine group ( p < 0.05 ) , whereas no change was evident in the placebo group . CONCLUSIONS High-dose intravenous N-acetylcysteine reduces oxidative stress . However , it does not provide an additional clinical benefit to placebo with respect to CIN and myocardial reperfusion injury in nonselected patients undergoing angioplasty with moderate doses of contrast medium and optimal hydration . ( Myocardial Salvage and Contrast Dye Induced Nephropathy Reduction by N-Acetylcysteine [ LIPSIA-N-ACC ] ; NCT00463749 ) Objective To evaluate the oxidative stress status and the modification with glucose-insulin-potassium ( GIK ) therapy in patients with acute myocardial infa rct ion undergoing primary percutaneous transluminal coronary angioplasty . Design Prospect i ve , r and omized , double-blinded , placebo-controlled study . Setting Cardiac intensive care unit at the university hospital . Patients Twenty patients were r and omized to GIK solution ( 30 % glucose in water with insulin 50 IU/L , and KCl 40 mM ) vs. placebo ( normal saline ) at 1.5 mL/kg/hr for 24 hrs . The control group was 15 healthy volunteers with no heart disease . Interventions Eligible patients were r and omized by a blinded pharmacist , patients with acute myocardial infa rct ion were treated by primary percutaneous transluminal coronary angioplasty and r and omized to GIK or placebo ( saline solution ) . Primary angioplasty was successful in nine of ten patients ( 90 % ) and ten of ten patients ( 100 % ) in the GIK and placebo groups , respectively . Nine ( 100 % ) and six ( 60 % ) patients from GIK and placebo groups , respectively , underwent stent implantation . Measurements and Main Results We determined plasma levels of lipid peroxidation estimated by the malondialdehyde assay , superoxide dismutase , glutathione peroxidase , and catalase erythrocyte activities at admission and 0.5 and 24 hrs after angioplasty . Baseline determinations were compared with a control group ( n = 15 ) . Baseline clinical characteristics and time to treatment ( 4.5 ± 3.5 hrs ) were similar between groups . Angioplasty success rate ( Thrombolysis in Myocardial Infa rct ion [ TIMI ] 3 flow with residual stenosis ≤30 % ) was 90 % and 100 % in GIK and placebo groups , respectively . Patients with acute myocardial infa rct ion had an increase of malondialdehyde at baseline ( 2.9 ± 1.7 vs. 1.1 ± 0.3 & mgr;M , p < .01 ) and lower enzymatic activities of superoxide dismutase ( 0.5 ± 0.5 vs. 1.3 ± 0.4 U/mg hemoglobin , p < .01 ) and catalase ( 147 ± 73 vs. 198 ± 31 U/g hemoglobin , p < .01 ) . These measurements did not change significantly after angioplasty and no differences were observed between GIK and placebo groups . Conclusion Patients with acute myocardial infa rct ion had increased levels of oxidative stress associated with a reduction in enzymatic antioxidant reserve . Administration of GIK solution did not improve these abnormalities among patients undergoing primary angioplasty Background —Accurate models to predict mortality are needed for risk stratification in patients with ST-segment elevation myocardial infa rct ion ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) . Methods and Results —We examined 5745 patients with STEMI undergoing primary PCI in the Assessment of Pexelizumab in Acute Myocardial Infa rct ion Trial within 6 hours of symptom onset . A Cox proportional hazards model incorporating regression splines to accommo date nonlinearity in the log hazard ratio ( HR ) scale was used to determine baseline independent predictors of 90-day mortality . At 90 days , 271 ( 4.7 % ) of 5745 patients died . Independent correlates of 90-day mortality were ( in descending order of statistical significance ) age ( HR , 2.03/10-y increments ; 95 % CI , 1.80 to 2.29 ) , systolic blood pressure ( HR , 0.86/10-mm Hg increments ; 95 % CI , 0.82 to 0.90 ) , Killip class ( class 3 or 4 versus 1 or 2 ) ( HR , 4.24 ; 95 % CI , 2.97 to 6.08 ) , heart rate ( > 70 beats per minute ) ( HR , 1.45/10-beat increments ; 95 % CI , 1.31 to 1.59 ) , creatinine ( HR , 1.23/10-&mgr;mol/L increments > 90 & mgr;mol/L ; 95 % CI , 1.13 to 1.34 ) , sum of ST-segment deviations ( HR , 1.25/10-mm increments ; 95 % CI , 1.11 to 1.40 ) , and anterior STEMI location ( HR , 1.47 ; 95 % CI , 1.12 to 1.93 ) ( c-index , 0.82 ) . Internal validation with bootstrapping confirmed minimal overoptimism ( c-index , 0.81 ) . Conclusions —Our study provides a practical method to assess intermediate-term prognosis of patients with STEMI undergoing primary PCI , using baseline clinical and ECG variables . This model identifies key factors affecting prognosis and enables quantitative risk stratification that may be helpful in guiding clinical care and for risk adjustment for observational analyses Objectives : The aims of this study were to investigate the effects of atorvastatin pretreatment on the oxygen free radicals and its protective role on the myocardial cell during the ischemic reperfusion injury . Methods : One hundred fifty-six patients with ST elevation myocardial infa rct ion undergoing percutaneous coronary interventions , aged from 29 to 85 years , were selected . Eighty patients were r and omly assigned to placebo group and 76 to statin treatment ( 80-mg loading dose given a mean of 1.5 hours before percutaneous coronary intervention ) . The nitrogen monoxidum , malondialdehyde , and superoxide dismutase ( SOD ) were assayed before and after reperfusion . Thrombolysis in myocardial infa rct ion ( TIMI ) grade and corrected TIMI frame count were measured after reperfusion . The creatine kinase-MB and troponin T peak levels after myocardial infa rct ion were recorded . Results : There was no significant difference in the nitrogen monoxidum , malondialdehyde , and SOD levels ( P > 0.05 ) between the 2 groups before intervention . After the reperfusion , significantly lower creatine kinase-MB ( 289.9 ± 180.8 U/L vs. 360.5 ± 206.4 U/L , P = 0.025 ) and troponin T ( 4.60 ± 3.13 ng/mL vs. 6.01 ± 4.98 ng/mL , P = 0.035 ) peak levels can be observed in the statin versus the placebo group , and the SOD level of the statin group is higher than that of the placebo group ( 34.14 ± 15.07 U/mL vs. 29.06 ± 12.76 U/mL , P = 0.024 ) . Conclusions : Atorvastatin can reduce oxygen free radicals developed in reperfusion , imposing protective effect on the myocardial cell during ischemic reperfusion injury This clinical pilot study was a r and omized , controlled , open-label study in 80 patients with acute myocardial infa rct ion and was design ed to examine the effects of a novel free radical scavenger , edaravone . Administration of edaravone before myocardial reperfusion was associated with smaller enzymatic infa rcts and better clinical outcome Background : In acute myocardial infa rct ion ( AMI ) treated with percutaneous coronary intervention ( PCI ) , myocardial injury results from complex processes during both ischemia and reperfusion . Release of reactive oxygen species ( ROS ) may contribute to the accumulated myocardial damage . Aims : To examine by frequent sampling of peripheral blood oxidative stress and early inflammation in patients under \n Output:\n " }, { "from": "agent", "value": "Results Administration of edaravone , allopurinol , atorvastatin and nicor and il as a supplement to primary PCI significantly reduced oxidative stress and myocardial damage as well as improved cardiac function and clinical outcomes ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : The aim of this study is to evaluate the effectiveness of life review ( LR ) based on specific positive events in non-depressed older adults taking part in an active aging program . Method : Fifty-five older adults were r and omly assigned to an experimental group or an active control ( AC ) group . A six-session individual training of LR based on specific positive events was carried out with the experimental group . The AC group undertook a “ media workshop ” of six sessions focused on learning journalistic techniques . Pre-test and post-test measures included life satisfaction , depressive symptoms , experiencing the environment as rewarding , and autobiographical memory ( AM ) scales . Results : LR intervention decreased depressive symptomatology , improved life satisfaction , and increased specific memories . Discussion : The findings suggest that practice in AM for specific events is an effective component of LR that could be a useful tool in enhancing emotional well-being in active aging programs , thus reducing depressive symptoms Surviving events that have posed a serious threat to life can result in major psychological problems during the recovery period . Younger patients , with years of life ahead of them , are at risk of depression and loss of self-esteem following their ordeal , despite their physical recovery . Traditional forms of counselling and psychotherapy following traumatic events can sometimes carry a stigma and be viewed as ' disease centred ' . Reminiscence and life review therapies , used until now , with the elderly , appear to have valuable transferable benefits to younger survivors of critical illness . Life review and reminiscent interventions are holistic and person centred , techniques resonating with the essence of critical care nursing . Life review and reminiscence can be used therapeutically from an early stage to help minimize the negative psychological effects of being critically ill The purpose of this r and omized , controlled trial was to test the efficacy of a community-based intervention , the Life Story Workshop , on depressive symptoms , operationalized as depression subscale scores on the Brief Symptom Inventory 18 , in adults age 60 and older . Thirty-three men and women were r and omly assigned to one of two groups : an intervention group that attended 2-hour workshops once a week for 10 weeks or a wait-list control group . The intervention provided an opportunity for older participants to reflect on , write , and share stories about their lived and current lives . The depression subscale of the Brief Symptom Inventory 18 was administered before and after the workshops . Mean depression scores were compared using Welch 's t test . A significant improvement was measured for the intervention group compared with the control group ( p = .03 ) . This research supports the Life Story Workshop as an effective intervention for improving depressive symptoms in older adults OBJECTIVE This study was aim ed at evaluating whether a Life Review Group Program ( LRGP ) improved the self-esteem and life satisfaction in the elderly . METHODS This r and omized , controlled trial consisted of 75 elderly males from a Veterans ' Home in Northern Taiwan , 36 of whom were in the experimental group and 39 of whom were in the control group . The subjects in the experimental group participated in an 8-week LRGP . Data were collected before and after the LRGP and again 1 month after the end of the program . RESULTS The study subjects had a mean age of 78.13 years . The generalized estimating equation was used to compare alterations in the self-esteem and life satisfaction of the elderly before and after the intervention . The alterations in self-esteem and life satisfaction in the experimental group after the LRGP were significantly improved compared to the control group . One month after the LRGP was completed , the self-esteem and life satisfaction of the experimental group continued to improve when compared with pre-intervention levels . CONCLUSIONS Based on these results , the LRGP can potentially improve the self-affirmation , confidence , and self-esteem of the elderly and promote short-term life satisfaction . The results of this study provide a model for clinical evidence -based therapy , serving as a reference for related studies and evaluation of health-promoting programs , as well as improving the health and quality of care of the elderly BACKGROUND France has high rates of psychotropic drug consumption and suicide in the elderly population , but it has not yet been possible to determine whether this is due to exceptionally high morbidity rates . AIMS To describe the first longitudinal population study of psychiatric disorder undertaken in France , and to estimate current and lifetime prevalences and age of onset of psychiatric disorder . METHOD A study group of 1873 non-institutionalised persons aged 65 years and over was r and omly recruited from the Montpellier district electoral rolls . The Mini International Neuropsychiatric Interview was used to assess current and lifetime symptoms . Cases identified by the application of DSM-IV criteria were re-examined by a clinical panel . RESULTS Forty-six per cent of the study population had experienced a mental disorder in their lifetime , and 3.7 % had made a suicide attempt . Lifetime prevalence of major depression was 26.5 % and 30 % for anxiety disorders . Current prevalence rates were 14.2 % for anxiety disorders , 10.7 % for phobia , 3 % for major depression and 1.7 % for psychosis . CONCLUSIONS Results show very high rates of lifetime but not current major depression . Rates of current phobia and suicidal ideation in the very elderly are also high compared with other studies . The rates reported are likely to be underestimates This study examined the underlying variables of selected reminiscing processes to determine those that contributed to well-being . Two hundred and forty subjects r and omly selected from nursing homes and high-rises participated in one of 10 different reminiscing modalities for eight weeks . Measures of life satisfaction ( LSI-A ) , psychological well being ( ABS ) , self-esteem ( SES ) , and depression ( BDI ) were given pre- and postintervention to determine the most therapeutic treatment modalities . Results showed the most therapeutic way to reminisce was through a structured , evaluative life review performed on an individual basis . Thus , three variables contributed to successful reminiscing : individuality ( one-to-one reminiscing ) , evaluation ( a personal valuing of events ) , and structure ( covering the whole life span ) People living with AIDS ( PLWA ) are confronted with uncertainty and their own mortality at an earlier than expected age . Life review , an intervention that has the potential to increase life satisfaction in the elderly experiencing transition points in their lives , may have a similar effect when used with PLWA . Therefore , the purpose of this feasibility study was to explore the use of life review in a sample of 20 PLWA through a r and omized controlled trial of its effectiveness in decreasing depressive symptoms and in increasing self esteem , quality of life , and purpose in life . Compared to the control group , the treatment group had an improved overall quality of life and self-esteem over 12 months , less depressive symptoms over 12 months , and a greater purpose in life at 3 months . The effects that were seen were mainly small to medium effects . The findings from this feasibility study suggest the potential value of life review to enhance quality of life , purpose in life , and self-esteem , and to decrease depressive symptoms in PLWA . Further research is needed with a larger sample and with other groups such as PLWA experiencing virologic failure Background : The objective of this study was to evaluate the mid-term efficacy of life review activities on the quality of life ( QOL ) of the elderly by conducting a r and omized controlled trial , and to identify the factors that should be taken into consideration when conducting life review activities . Methods : Written consent was obtained from 80 of the 97 eligible elderly persons . After r and omly assigning them to two groups , an intervention group and a control group , group life review activities were conducted in the intervention group and discussion activities about health were conducted in the control group . In both the intervention group and the control group , life satisfaction , self-esteem , depression , and hopelessness were evaluated using self-rating scales at three points : at baseline , immediately after completion of the 8 weeks of sessions , and 3 months after completion of the intervention . Results : Repeated measures analysis of covariance showed significant differences between the two groups in the changes in scores for depression ( p = 0.04 ) and hopelessness ( p = 0.04 ) . Regarding the factors that were associated with depression and hopelessness , 3 months after completion of the intervention , depression and hopelessness of a more severe nature at baseline and having greater unresolved conflicts in the past were extracted by multiple regression analysis . Conclusions : The results suggested that group life review activities have a role in assisting the developmental stage of old age and supporting mental health , and have mid- to long-term effectiveness in maintaining and improving the QOL of the elderly Background and aims : As life expectancy rises worldwide and the population grows older , psychopathology in older adults becomes a significant public health concern and intervention methods acquire renewed importance . The aim of the present study was to assess the efficacy of Life Review as an intervention strategy in working with older women with depressive symptoms , specifically through promotion of the specificity of autobiographical memories . Methods : Twenty-two participants were r and omly assigned to experimental or control conditions . Intervention consisted of four individual sessions of Life Review , structured along 14 questions aim ed at prompting autobiographical memory specificity . Participants in the control condition did not receive intervention . Results : Results indicated a significant change in the experimental group , appearing as the reduction of depressive symptoms ( t(20)=3.58 , p<0.05 ) and an increase in life satisfaction ( t(20)=−3.83 , p<0.05 ) , as well as a significant increase in the specificity ( t(20)=−3.46 , p<0.05 ) and positivity ( t(20)=−4.23 , p<0.05 ) of autobiographical memories . All variables reached high effect sizes , with an effect size of r=0.64 regarding depressive symptoms . Conclusions : Results suggest that Life Review is a valuable tool for use with older adults , and that promotion of specific autobiographical memories is a mechanism through which the strategy attains its effectiveness OBJECTIVE We examined the effects of engaging in the occupation-based intervention of life review through writing on expressed depressive symptoms as measured with the Geriatric Depression Scale in older adults residing in senior residences . METHOD The study design was a r and omized controlled trial that took place in four senior residences in New York City . Forty-five participants ( 23 treatment , 22 wait-list control ) ≥ 65 yr old participated in the 8-wk , once-weekly autobiographical writing workshop , Share Your Life Story ( Sierpina , 2002 ) . RESULTS Depressive symptoms were significantly less prevalent for the treatment group than for the control group after the 8-wk life review program ( repeated- measures analysis of variance p = .03 ) . CONCLUSION The results suggest that the Share Your Life Story writing workshop is an effective occupation-based intervention for occupational therapists to use with older adults who reside in senior residences This pilot study sought to determine if the use of Life Review Therapy would result in lower levels of depression and higher degrees of life satisfaction in individuals with right hemisphere cerebral vascular accidents ( CVAs ) . Fourteen subjects in a southern rehabilitation center were r and omly assigned to either an experimental or control group . The experimental group received three one-hour sessions of Life Review Therapy and the control group viewed three one-hour sessions of neutral video with a follow-up discussion . Following the third session of each group , subjects were administered the Zung Scale for Depression and the Life Satisfaction Index — Form Z. A one-way ANOVA revealed a significantly lower level of depression ( p < .01 ) and a significantly higher degree of life satisfaction ( p < .01 ) in the Life Review Therapy group The aim of this study was to examine the efficacy of life review based on autobiographical retrieval practice for treating depressed older adults . Forty-three adults aged 65 - 93 with clinical ly significant depressive symptomatology and no dementia were r and omly assigned to treatment or to no treatment . The results indicated significant differences between experimental and control groups after 4 weeks of autobiographical retrieval practice . At posttest , those in the treatment condition showed fewer depressive symptoms , less hopelessness , improved life satisfaction , and retrieval of more specific events . The findings suggest that practice in autobiographical memory for specific events may be among the components of life review that account for its effectiveness and could be a useful tool in psychotherapy with older adults OBJECTIVES To study the onset and compare risk factors for pure depression ( DEP ) , pure anxiety ( ANX ) , and comorbid anxiety-depression ( ANXDEP ) in the aging population . DESIGN Prospect i ve study with 3-year intervals over a 9-year period . SETTING Data of the Longitudinal Aging Study Amsterdam were used , which is a population -based study among older adults ( 55 - 85 years at baseline ) . PARTICIPANTS Older adults free of depression and anxiety at baseline ( N = 1,712 ) . MEASUREMENTS Clinical ly relevant levels of depression and anxiety were measured with the Center for Epidemiologic Studies Depression scale > or = 16 and Hospital Anxiety and Depression Scale > or = 7 , respectively . A broad range of potential sociodemographic , health , and psychosocial risk factors for anxiety and /or depression were examined by using polytomous logistic regression analyses . RESULTS Within 9 years , 184 subjects ( 10.8 % ) developed DEP , 93 ( 5.4 % ) ANX , and 103 ( 6.0 % ) ANXDEP . Concerning sociodemographics , higher age and lower educational level were predictors for DEP . Health indicators were predictive for DEP and ANXDEP but not for ANX . Depressive symptoms at baseline were predictive for DEP , whereas initial anxiety symptoms were predictive for ANX and ANXDEP . Neuroticism increased the risk of DEP and ANXDEP . Mixed effects of psychosocial variables were found : DEP was associated with recent widowhood , whereas ANX and ANXDEP were associated with \n Output:\n " }, { "from": "agent", "value": "Life review is a worthwhile intervention for reducing depression and hopelessness , and improving quality of life , well-being and specific memory in older adults ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n 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 Abstract . The aim of this r and omized in vivo study was to compare antimicrobial chemotherapies in primary carious dentin . Thirty-two participants ages 5 to 7 years underwent partial caries removal from deep carious dentin lesions in primary molars and were subsequently divided into three groups : control [ chlorhexidine and resin-modified glass ionomer cement ( RMGIC ) ] , LEDTB [ photodynamic antimicrobial chemotherapy ( PACT ) with light-emitting diode associated with toluidine blue solution and RMGIC ] , and LMB [ PACT with laser associated with methylene blue solution and RMGIC ] . The participants were su bmi tted to initial clinical and radiographic examinations . Demographic features and biofilm , gingival , and DMFT/DMFS indexes were evaluated , in addition to clinical and radiographic followups at 6 and 12 months after treatments . Carious dentin was collected before and after each treatment , and the number of Streptococcus mutans , Streptococcus sobrinus , Lactobacillus casei , Fusobacterium nucleatum , Atopobium rimae , and total bacteria was established by quantitative polymerase chain reaction . No signs of pain or restoration failure were observed . All therapies were effective in reducing the number of microorganisms , except for S. sobrinus . No statistical differences were observed among the protocol s used . All therapies may be considered as effective modern approaches to minimal intervention for the management of deep primary caries treatment OBJECTIVES : The aim of the present study was to analyze the efficacy of Papacarie ® gel compared with the traditional method ( low-speed bur ) in reducing the counts of total bacteria , Lactobacillus , total Streptococcus and Streptococcus mutans group . METHODS : A r and omized , controlled clinical trial with a split-mouth design was performed . The sample comprised 40 deciduous teeth in 20 children ( 10 males and 10 females ) aged four to seven years . The teeth were r and omly allocated to two groups : G1 , or chemomechanical caries removal with Papacarie Duo ® , and G2 , or the removal of carious dentin tissue with a low-speed bur . Infected dentin was collected prior to the procedure , and the remaining dentin was collected immediately following the removal of the carious tissue . Initial and final counts of bacterial colonies were performed to determine whether there was a reduction in the number of colony-forming units ( CFUs ) of each microorganism studied . Clinical Trials.gov : NCT01811420 . RESULTS : Reductions were found in the numbers of total bacteria , total Streptococcus and Streptococcus mutans group following either of the caries removal methods ( p<0.05 ) . A reduction was also noted in the number of Lactobacillus CFUs ; however , this difference did not achieve statistical significance ( p>0.05 ) . CONCLUSION : Papacarie ® is an excellent option for the minimally invasive removal of carious tissue , achieving significant reductions in total bacteria , total Streptococcus and S. mutans with the same effectiveness as the traditional caries removal method BACKGROUND Ultraconservative removal of carious tissue is becoming increasingly highlighted for management of deep caries lesions , and combined with an antimicrobial photochemistry-based treatment modality ( PACT ) , this approach can be enhanced favoring dental tissue repair and preservation . The aim was to investigate the effectiveness of PACT using a light emitting diode ( LED ) associated with a photosensitizer toluidine blue ortho ( TBO ) on deep caries lesions . METHODS For that , a single blind , r and omized , controlled , split-mouth clinical trial where 45 patients with at least two deep carious lesions on permanent posterior teeth was performed . The primary intervention was deep caries lesion management with disinfection of remaining dentin tissue using PACT . Bacterial counts were measured following treatments as the main outcome . The remaining dentinal sample s of each lesion were treated with either non-PACT-control or PACT . The PACT procedure were characterized by 100 μg mL(-1 ) TBO followed by 94J cm(-2 ) LED irradiation . Sample s of dentin were collected before and immediately after treatments for microbiological analysis of total viable bacteria , mutans streptococci and Lactobacillus spp . counts . Microbial reduction was data were su bmi tted to unpaired t test ( α=5 % ) . RESULTS PACT led to statistically significant reductions in mutans streptococci ( 1.08 ± 1.20 log ) , Lactobacillus spp . ( 1.69 ± 1.37 log ) , and total viable bacteria ( 1.07 ± 1.01 log ) compared to the control , which showed log reductions respectively of 0.05 ± 0.49 , 0.52 ± 0.89 , and 0.47 ± 0.77 for the same microorganisms . CONCLUSION Dentin from deep carious lesions treated with PACT showed a decrease in cariogenic microbial load \n Output:\n " }, { "from": "agent", "value": "All results from the selected studies showed a significant reduction of microorganisms in deep carious lesions for both primary and permanent teeth .\nBased on these findings , there is scientific evidence emphasizing the effectiveness of aPDT in reducing microorganisms in deep carious lesions" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE this study was conducted to evaluate the feasibility and acceptability of a managed-care approach ( group visits ) on delivering care to uninsured or inadequately insured patients with type 2 diabetes . METHODS One hundred twenty patients with uncontrolled type 2 diabetes were r and omly assigned to receive care in group visits or usual care for 6 months . At baseline , 3 months , and 6 months , the feasibility and acceptability of this model of healthcare delivery were assessed through the patients ' responses to the Primary Care Assessment Tool and the Trust in Physician Scale . Attendance records were kept for each group . RESULTS Patients who received care in group visits showed an improved sense of trust in their physician compared with patients who continued to receive usual care . There was a tendency for patients in groups to report better coordination of their care , better community orientation , and more culturally competent care . Patient attendance at the groups also indicated good acceptance of this form of healthcare delivery . CONCLUSIONS Group visits were feasible and acceptable to these uninsured and inadequately insured patients with uncontrolled type 2 diabetes and fostered an improved sense of trust in their physician PURPOSE The purpose of the study was to evaluate perceptions of care delivered through group visits to disadvantaged patients with type 2 diabetes . METHODS One hundred eighty-six patients with uncontrolled type 2 diabetes were r and omly assigned to receive care in group visits or usual care for 12 months . Their perceptions of the care they received were measured at baseline and 6 and 12 months by the Primary Care Assessment Tool ( PCAT ) , the Diabetes-Specific Locus of Control ( DLC ) survey , and the Trust in Physician Scale ( TPS ) . RESULTS Compared to patients in usual care , group visit patients ' PCAT scores were higher in the domains of ongoing care ( P = .001 ) , community orientation ( P < .0001 ) , and cultural competence ( P = .022 ) . In addition , group patients had higher scores for the Powerful-Other Health Professional subscale of the DLC survey ( P = .010 ) . CONCLUSIONS Patients assigned to group visits had generally more positive perceptions about their care in the areas of ongoing care , community orientation of care , and cultural competence of care than did those in usual care . The perception that one 's health professional is powerful , however , has been associated with a reluctance of patients to make medication changes on their own in previous studies . These findings suggest the need for modification in the way that group visits are conducted to empower and activate patients while still delivering continuous , culturally competent , and community-oriented care BACKGROUND Poor quality of information transfer about the benefits and risks of statin drug use may result in patients not making informed decisions that they can act on in a timely fashion . METHODS The effect of a decision aid about statin drugs on treatment decision making in 98 patients with diabetes was determined in a cluster r and omized trial of decision aid vs control pamphlet , with concealed allocation , blinding of participants to study goals , and adherence to the intention-to-treat principle . Twenty-one endocrinologists conducted specialty outpatient metabolic consultations . Patients in the intervention group received Statin Choice , a tailored decision aid that presents the estimated 10-year cardiovascular risk , the absolute risk reduction with use of statin drugs , and the disadvantages of using statin drugs . Patients in the control group received the institution 's pamphlet about cholesterol management . We measured acceptability , knowledge about options and cardiovascular risk , and decisional conflict immediately after the visit , and adherence to pill taking was measured 3 months later . RESULTS Patients favored using the decision aid ( odds ratio [ OR ] , 2.8 ; 95 % confidence interval [ CI ] , 1.2 - 6.9 ) ; patients who received the decision aid ( n = 52 ) knew more ( difference , 2.4 of 9 points ; 95 % CI , 1.5 - 3.3 ) , had better estimated cardiovascular risk ( OR , 22.4 ; 95 % CI , 5.9 - 85.6 ) and potential absolute risk reduction with statin drugs ( OR , 6.7 ; 95 % CI , 2.2 - 19.7 ) , and had less decisional conflict ( difference , -10.6 ; 95 % CI , -15.4 to -5.9 on a 100-point scale ) than did patients in the control group ( n = 46 ) . Of 33 patients in the intervention group taking statin drugs at 3 months , 2 reported missing 1 dose or more in the last week compared with 6 of 29 patients in the control group taking statin drugs ( OR , 3.4 ; 95 % CI , 1.5 - 7.5 ) . CONCLUSIONS A decision aid enhanced decision making about statin drugs and may have favorably affected drug adherence OBJECTIVE Assess use of and reactions to an interactive , tailored CD-ROM to enhance oncologist-patient communication . METHODS Participating oncologists ( n=48 ) agreed to have patient interactions audio recorded , be r and omly assigned to receive/not receive a CD-ROM , have CD-ROM usage monitored ( intervention group ) and complete a follow-up survey . RESULTS Twenty-one of 24 in the intervention group reported using the CD-ROM . Median usage minutes were 63.8 . At follow-up , oncologists rated the CD-ROM from 1 ( \" none \" or \" not at all helpful \" ) to 5 ( \" a great deal \" or \" very helpful \" ) . Mean responses were : 3.1 and 3.0 for 2 items assessing perceived impact on communications , 3.8 - 4.0 for 6 items assessing perceived helpfulness , 3.0 and 3.10 for 2 items assessing impact on affecting oncologists ' communication with patients and assistance with challenging conversations , respectively , and 3.6 for whether using the CD-ROM was worth their time . Self-report of how much oncologists had used the covered skills before and after intervention showed a perceived increase ( 2.8 before and 3.2 after ) . CONCLUSIONS Findings suggest the tailored interactive CD-ROM has promise for use and acceptance among oncologists . PRACTICE IMPLICATION S If ultimately found effective in changing oncologist 's communication with patients , the CD-ROM 's widespread dissemination should be explored Abstract BACKGROUND : Disclosure of medical errors is encouraged , but research on how patients respond to specific practice s is limited . OBJECTIVE : This study sought to determine whether full disclosure , an existing positive physician-patient relationship , an offer to waive associated costs , and the severity of the clinical outcome influenced patients ’ responses to medical errors . PARTICIPANTS : Four hundred and seven health plan members participated in a r and omized experiment in which they viewed video depictions of medical error and disclosure . DESIGN : Subjects were r and omly assigned to experimental condition . Conditions varied in type of medication error , level of disclosure , reference to a prior positive physician-patient relationship , an offer to waive costs , and clinical outcome . MEASURES : Self-reported likelihood of changing physicians and of seeking legal advice ; satisfaction , trust , and emotional response . RESULTS : Nondisclosure increased the likelihood of changing physicians , and reduced satisfaction and trust in both error conditions . Nondisclosure increased the likelihood of seeking legal advice and was associated with a more negative emotional response in the missed allergy error condition , but did not have a statistically significant impact on seeking legal advice or emotional response in the monitoring error condition . Neither the existence of a positive relationship nor an offer to waive costs had a statistically significant impact . CONCLUSIONS : This study provides evidence that full disclosure is likely to have a positive effect or no effect on how patients respond to medical errors . The clinical outcome also influences patients ’ responses . The impact of an existing positive physician-patient relationship , or of waiving costs associated with the error remains uncertain BACKGROUND Concern regarding financial conflict of interest for physicians has led to calls for disclosure of financial incentives to patients . However , limited data on the outcomes of disclosure exist to guide policy . METHODS This r and omized trial was conducted among 8000 adult patients at 2 multispecialty group practice s based in the Boston , Mass , and Los Angeles , Calif , areas . Intervention patients were mailed a compensation disclosure letter written by the chief medical officer of their physician group , and all patients were surveyed approximately 3 months later . RESULTS Disclosure patients were significantly more able to identify correctly the compensation model of their primary care physician , in Boston ( adjusted odds ratio , 2.30 ; 95 % confidence interval , 1.92 - 2.75 ) and in Los Angeles ( adjusted odds ratio , 1.37 ; 95 % confidence interval , 1.03 - 1.82 ) . Disclosure patients also had more confidence in their ability to judge the possible influence of incentives on their health care : in Boston , 32.5 % vs 17.8 % ( P<.001 ) ; and in Los Angeles , 31.8 % vs 26.4 % ( P = .20 ) . The disclosure intervention did not change trust in primary care physicians overall . However , of patients who remembered receiving the disclosure , 21.4 % in Boston and 24.4 % in Los Angeles responded that the disclosure had increased trust either greatly or somewhat , while in both cities less than 5 % of patients responded that the information decreased trust . Patients ' loyalty to their physician group was higher among disclosure patients in Boston ( 73.4 % vs 70.2 % ; P = .03 ) and Los Angeles ( 74.1 % vs 66.9 % ; P = .08 ) . CONCLUSIONS Among diverse patient population s , a single mailed disclosure letter from physician groups was associated with improved knowledge of physicians ' compensation models . Patients ' trust in their physicians was unharmed , and their loyalty to their physician group was strengthened . For physician groups with similar compensation programs , disclosure to patients should be considered an effective method to enhance the patient-physician relationship BACKGROUND Many physicians receive financial incentives to limit their ordering of expensive tests and procedures . While Medicare m and ates disclosure of incentives , it is not clear how to inform patients without undermining trust . METHODS Our objective was to determine public opinion about physician disclosure of financial incentives and how this might be best communicated to patients . The 2002 General Social Survey included 2765 interviews from a probability sample of English-speaking US households . The interview included questions about financial incentives and an audiotaped scenario of a physician discussing the impact of financial incentives on ordering a magnetic resonance image . Respondents heard 1 of 6 r and omly selected disclosure strategies . The measurements included ratings of trust , satisfaction , agreement with the physician 's decision , and likelihood of remaining with the physician/health plan or seeking a second opinion . RESULTS Nearly half ( 48.8 % ) of respondents had previously heard of financial incentives to limit test ordering . Of the respondents , 94.8 % wanted to be told about incentives , at the time of enrollment in a health plan ( 80.5 % ) , by a health plan representative ( 44.8 % ) , their physician ( 17.1 % ) , or both ( 38.1 % ) . Of the 6 different disclosure strategies , \" addressing emotions \" and \" negotiation \" were associated with the best outcomes , while \" common enemy \" and \" denying influences \" were most negatively perceived . Black and Hispanic subjects were less likely to express satisfaction or trust and more likely to disenroll or seek a second opinion . CONCLUSIONS The public wants information about physician financial incentives . Specific communication styles enhance how this information is conveyed to patients , increasing trust and supporting the physician-patient relationship OBJECTIVE To assess the impact of patient-centered communication ( PCC ) behaviors on patients ' evaluations of physicians and acceptance of clinical recommendations . METHODS We r and omized 248 patients to view video-recorded , st and ardized vignettes , depicting a cardiologist using a high vs. low degree of PCC while recommending bypass surgery to a patient with angina and 3-vessel coronary artery disease . We compared patients ' ratings of the physician and their decision making in response to the physician 's recommendation , for high vs. low PCC vignettes . RESULTS Patients viewing high PCC vignettes rated the video physician more favorably overall ( 3.01 vs. 2.12 , p<0.001 ) and as more competent ( 3.22 vs. 2.66 , p<0.001 ) and trustworthy ( 2.93 vs. 2.28 , p<0.001 ) than those viewing the low PCC version ( 0 - 4 range for all scales ) . Patients viewing the high PCC version more frequently said they would undergo bypass surgery ( 96 % vs. 74 % , p<0.001 ) if they were the patient in the video . CONCLUSION Patients expressed greater confidence in physicians who used more PCC behaviors , and greater willingness to accept an evidence -based recommendation . PRACTICE IMPLICATION S PCC may make physicians more effective in the delivery of evidence -based care Existing scales to measure trust in physicians have differing content and limited testing . To improve on these measures , a large item pool ( n = 78 ) was generated following a detailed conceptual model and expert review . After pilot testing , the best-performing items were vali date d with a r and om national sample ( n = 9 ) and a regional sample of HMO members ( n = 99 ) . Various psychometric tests produced a 10-item unidimensional scale consistent with most aspects of the conceptual model . Compared with previous scales , the Wake Forest physician trust scale has a somewhat improved combination of internal consistency , variability , and discriminability . The scale is more strongly correlated with satisfaction , desire to remain with a physician , willingness to recommend to friends , and not seeking second opinions ; it is less correlated with insurer trust , membership in managed \n Output:\n " }, { "from": "agent", "value": "Overall , there remains insufficient evidence to conclude that any intervention may increase or decrease trust in doctors .\nThis may be due in part to the sensitivity of trust instruments , and a ceiling effect , as trust in doctors is generally high ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: 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 The influence of the source of dietary fat on postpr and ial thermogenesis and substrate oxidation rates , was examined in twelve postmenopausal women aged 57 - 73 years , with BMI 21.9 - 38.3 kg/m(2 ) . A single blind , r and omised , paired comparison of two high-fat , isoenergetic , mixed test meals was conducted . The major source of fat was either cream ( CREAM ) or extra virgin olive oil ( EVOO ) . RMR , diet-induced thermogenesis ( DIT ) and substrate oxidation rates over 5 h were measured by indirect calorimetry . There were no differences in body weight , RMR , fasting carbohydrate or fat oxidation rates between the two occasions . DIT ( EVOO 97 ( SD 46 ) v. CREAM 76 ( SD 69 ) kJ/5 h and EVOO 5.2 ( SD 2.5 ) v. CREAM 4.1 ( SD 3.7)% energy ) did not differ between the two test meals . The postpr and ial increase in carbohydrate oxidation rates , relative to their respective fasting values ( DeltaCOX ) , was significantly lower following the EVOO meal ( EVOO 10.6 ( SD 8.3 ) v. CREAM 17.5 ( SD 10 ) g/5 h ; paired t test , P=0.023 ) , while postpr and ial fat oxidation rates ( DeltaFOX ) were significantly higher ( EVOO 0.0 ( SD 4.4 ) v. CREAM -3.6 ( sd 4.0 ) g/5 h ; P=0.028 ) . In the eight obese subjects , however , DIT was significantly higher following the EVOO meal ( EVOO 5.1 ( SD 2.0 ) v. CREAM 2.5 ( sd 2.9 ) % ; P=0.01 ) . This was accompanied by a significantly lower DeltaCOX ( EVOO 10.9 ( SD 9.9 ) v. CREAM 17.3 ( SD 10.5 ) g/5 h ; P=0.03 ) and significantly higher DeltaFOX ( EVOO 0.11 ( SD 4.4 ) v. CREAM -4.1 ( SD 4.5 ) g/5 h , P=0.034 ) . The present study showed that olive oil significantly promoted postpr and ial fat oxidation and stimulated DIT in abdominally obese postmenopausal women The aim of this dynamic prospect i ve follow-up study was to assess the association between olive oil consumption and the likelihood of weight gain or the incidence of overweight or obesity in a large Mediterranean cohort of 7,368 male and female Spanish university graduates ( the SUN Project ) who were followed for a median period of 28.5 mon . A vali date d Food Frequency Question naire was administered at baseline , and respondents also completed a follow-up question naire after 28.5 mon . Changes in participants ' consumption of olive oil and their weight were assessed during follow-up . A higher baseline consumption of olive oil was associated with a lower likelihood of weight gain , although the differences were not statistically significant . The adjusted difference in weight gain ( kg ) was −0.16 [ 95 % confidence interval ( C1 ) : −0.42 to + 0.11 ] for participants in the upper quintile of olive oil consumption ( median : 46 g/d ) compared with those in the lowest quintile ( median : 6 g/d ) . For participants with a high baseline consumption of olive oil whose olive oil consumption also increased during follow-up , we found a slightly increased but nonsignificant risk of incidence of over-weight or obesity ( adjusted odds ratio=1.19 , 95 % C1 : 0.73 to 1.95 ) . Our study , carried out in a sample of free-living people , shows that a high amount of olive oil consumption is not associated with higher weight gain or a significantly higher risk of developing overweight or obesity in the context of the Mediterranean food pattern Six healthy adult males were fed four different diets to determine the effects of the quantity of fat ( 30 % or 40 % of energy as fat ) and type of fat ( polyunsaturated or saturated ) on utilization of fatty acids . Each diet was fed for 15 d. The ratio of dietary polyunsaturated to saturated fat ( P : S ) was formulated at either 0.2 or 1.0 at both fat intakes . Subjects provided breath tests to measure background 13C and response to [1 - 13C]10:0 and [1 - 13C]16:0 fed with a test meal . Increasing the P : S increased whole-body oxidation of labeled 10:0 by 30 % after consumption of both low- and high-fat diets . When labeled 16:0 was fed , the amount of 13C excreted in breath increased by a factor of 2.4 after the low-fat diet with a high P : S compared with the diet with a low P : S. The results suggest that the amount and type of fat in the diet affect utilization of individual fatty acids in normal subjects A r and omised crossover study of eight overweight or obese men ( aged 24 - 49 years , BMI 25.5 - 31.3 kg/m(2 ) ) , who followed two diets for 4 weeks each , was performed to determine whether substitution of saturated fat with monounsaturated fat affects body weight and composition . Subjects were provided with all food and beverages as modules ( selected ad libitum ) of constant macronutrient composition , but differing energy content . The % total energy from saturated fat , monounsaturated fat and polyunsaturated fat was 24 , 13 and 3 % respectively on the saturated fatty acid (SFA)-rich diet and 11 , 22 and 7 % respectively on the monounsaturated fatty acid (MUFA)-rich diet . MUFA accounted for about 80 % of the unsaturated fats consumed on both diets . Body composition , blood pressure , energy expenditure ( resting and postpr and ial metabolic rates , substrate oxidation rate , physical activity ) , serum lipids , the fatty acid profile of serum cholesteryl esters and plasma glucose and insulin concentrations were measured before and after each diet period . Significant ( P < or = 0.05 ) differences in total cholesterol and the fatty acid composition of serum cholesteryl esters provided evidence of dietary adherence . The men had a lower weight ( -2.1 ( SE 0.4 ) kg , P=0.0015 ) and fat mass ( -2.6 ( SE 0.6 ) kg , P=0.0034 ) at the end of the MUFA-rich diet as compared with values at the end of the SFA-rich diet . No significant differences were detected in energy or fat intake , energy expenditure , substrate oxidation rates or self-reported physical activity . Substituting dietary saturated with unsaturated fat , predominantly MUFA , can induce a small but significant loss of body weight and fat mass without a significant change in total energy or fat intake OBJECTIVE We examined associations between two Mediterranean diet ( MD ) adherence indexes ( the MD index , MDI , and the MD score , MDS ) and several blood biomarkers of diet and disease . SUBJECTS We studied 328 individuals from Catalonia ( Northeastern Spain ) , ages 18 - 75 , who provided fasting blood sample s , a subset of the 2346 individuals as part of a larger representative and r and om sample from the 1992 - 1993 Catalan Nutritional Survey . DESIGN AND METHOD Diet was measured using 24-h recalls . Biomarkers studied were plasma levels of beta-carotene , alpha-tocopherol , retinol , vitamins B12 , C and folates as well as serum total cholesterol , HDL cholesterol , LDL cholesterol and triglycerides . Multivariate linear regression was used to analyse associations of the nutrient biomarkers with the dietary pattern indexes , adjusting for potential confounders . RESULTS AND CONCLUSIONS Subjects with higher MD adherence , as measured by the two dietary indexes , had significantly higher plasma concentrations of beta-carotene , folates , vitamin C , alpha-tocopherol and HDL cholesterol . The most highly significant relationship was that between folates and the adherence to the MD Pattern , as determined by both indexes . These research findings suggest the potential usefulness of biomarkers as complementary tools for assessing adherence to a dietary pattern . This type of data not only informs the development of robust dietary adherence indexes , but it also provides specific clues about the potential physiological mechanisms that explain the beneficial effects of the MD pattern on chronic disease risk BACKGROUND Several studies have shown that adherence to the Mediterranean Diet measured by using the Mediterranean diet score ( MDS ) is associated with lower obesity risk . The newly proposed Nordic Diet could hold similar beneficial effects . Because of the increasing focus on the interaction between diet and genetic predisposition to adiposity , studies should consider both diet and genetics . OBJECTIVE We investigated whether FTO rs9939609 and TCF7L2 rs7903146 modified the association between the MDS and Nordic diet score ( NDS ) and changes in weight ( Δweight ) , waist circumference ( ΔWC ) , and waist circumference adjusted for body mass index ( BMI ) ( ΔWC BMI ) . DESIGN We conducted a case-cohort study with a median follow-up of 6.8 y that included 11,048 participants from 5 European countries ; 5552 of these subjects were cases defined as individuals with the greatest degree of unexplained weight gain during follow-up . A r and omly selected subcohort included 6548 participants , including 5496 noncases . Cases and noncases were compared in analyses by using logistic regression . Continuous traits ( ie , Δweight , ΔWC , and ΔWC BMI ) were analyzed by using linear regression models in the r and om subcohort . Interactions were tested by including interaction terms in models . RESULTS A higher MDS was significantly inversely associated with case status ( OR : 0.98 ; 95 % CI : 0.96 , 1.00 ) , ΔWC ( β = -0.010 cm/y ; 95 % CI : -0.020 , -0.001 cm/y ) , and ΔWC BMI ( β = -0.008 ; 95 % CI:-0.015 , -0.001 ) per 1-point increment but not Δweight ( P = 0.53 ) . The NDS was not significantly associated with any outcome . There was a borderline significant interaction between the MDS and TCF7L2 rs7903146 on weight gain ( P = 0.05 ) , which suggested a beneficial effect of the MDS only in subjects who carried 1 or 2 risk alleles . FTO did not modify observed associations . CONCLUSIONS A high MDS is associated with a lower ΔWC and ΔWC BMI , regardless of FTO and TCF7L2 risk alleles . For Δweight , findings were less clear , but the effect may depend on the TCF7L2 rs7903146 variant . The NDS was not associated with anthropometric changes during follow-up BACKGROUND AND AIMS Diets high in monounsaturated fatty acids ( MUFA ) such as a Mediterranean diet may reduce the risk of cardiovascular diseases by improving insulin sensitivity and serum lipids . Besides being high in MUFA , a Mediter \n Output:\n " }, { "from": "agent", "value": "This systematic review highlights the potential for a Mediterranean diet intervention to reduce central obesity and in turn reduce obesity-related chronic disease risk and associated public health burden" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Despite its effectiveness , methadone maintenance is rarely provided in American correctional facilities . This study is the first r and omized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction . METHODS A three-group r and omized controlled trial was conducted between September 2003 and June 2005 . Two hundred eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study . Participants were r and omly assigned to the following : counseling only : counseling in prison , with passive referral to treatment upon release ( n=70 ) ; counseling+transfer : counseling in prison with transfer to methadone maintenance treatment upon release ( n=70 ) ; and counseling+methadone : methadone maintenance and counseling in prison , continued in a community-based methadone maintenance program upon release ( n=71 ) . RESULTS Two hundred participants were located for follow-up interviews and included in the current analysis . The percentages of participants in each condition that entered community-based treatment were , respectively , counseling only 7.8 % , counseling+transfer 50.0 % , and counseling+methadone 68.6 % , p<.05 . All pairwise comparisons were statistically significant ( all ps<.05 ) . The percentage of participants in each condition that tested positive for opioids at 1-month post-release were , respectively , counseling only 62.9 % , counseling+transfer 41.0 % , and counseling+methadone 27.6 % , p<.05 , with the counseling only group significantly more likely to test positive than the counseling+methadone group . CONCLUSIONS Methadone maintenance initiated prior to or immediately after release from prison appears to have beneficial short-term impact on community treatment entry and heroin use . This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories Aim To test the efficacy and safety of osmotic release oral system ( OROS ) methylpheni date ( MPH ) in doses up to 180 mg/day to treat attention deficit hyperactivity disorder ( ADHD ) and prevent any drug relapse in individuals with a co-diagnosis of ADHD and amphetamine dependence . Design R and omized placebo-controlled 24-week double-blind trial with parallel groups design . Setting Participants were recruited from medium security prisons in Sweden . The medication started within 2 weeks before release from prison and continued in out-patient care with twice-weekly visits , including once-weekly cognitive behavioural therapy . Participants Fifty-four men with a mean age of 42 years , currently incarcerated , meeting DSM-IV criteria for ADHD and amphetamine dependence . Measurements Change in self-reported ADHD symptoms , relapse to any drug use ( amphetamine and other drugs ) measured by urine toxicology , retention to treatment , craving and time to relapse . Findings The MPH-treated group reduced their ADHD symptoms during the trial ( P = 0.011 ) and had a significantly higher proportion of drug-negative urines compared with the placebo group ( P = 0.047 ) , including more amphetamine-negative urines ( P = 0.019 ) and better retention to treatment ( P = 0.032 ) . Conclusions Methylpheni date treatment reduces attention deficit hyperactivity disorder symptoms and the risk for relapse to substance use in criminal offenders with attention deficit hyperactivity disorder and substance dependence BACKGROUND Screening , brief intervention , and referral to treatment ( SBIRT ) is an evidence -based practice that has been shown to reduce alcohol and drug use in healthcare , educational , and other setting s , but research on the effectiveness of SBIRT with population s involved in the criminal justice system is limited . These population s have high rates of substance use but have limited access to interventions . METHODS The study r and omized 732 jail inmates from a large urban jail to the SBIRT intervention or to the control group . Using the Alcohol , Smoking , and Substance Involvement Screening Test ( ASSIST ) , the intervention assessed the risk level for drug and alcohol misuse by inmates and provided those who were at low or medium risk with a brief intervention in jail and referred those at high risk to community treatment following release , including the opportunity to participate in a brief treatment ( eight sessions ) protocol . Using interview and records data from a 12-month follow-up , analyses compared the two groups with respect to the primary study outcomes of reductions in drug and alcohol use and the secondary outcomes of participation in treatment , rearrest , reduction in HIV risk behaviors , and quality of life . In addition , the costs of delivering the SBIRT intervention were calculated . RESULTS When baseline differences were controlled , the groups did not differ at follow-up on any of the primary or secondary outcomes . CONCLUSIONS Future research should develop and evaluate SBIRT models that are specifically adapted to the characteristics and needs of the jail population . Until more favorable results emerge , attempts to use SBIRT with jail inmates should be implemented with caution , if at all . TRIAL REGISTRATION NUMBER NCT01683643 This r and omized controlled pilot study compared a cognitive-behavioral therapy ( Seeking Safety ; SS ) plus treatment-as-usual ( TAU ) to TAU-alone in 49 incarcerated women with substance use disorder ( SUD ) and posttraumatic stress disorder ( PTSD ; full or subthreshold ) . Seeking Safety consisted of a voluntary group treatment during incarceration and individual treatment after prison release . TAU was required in the prison and comprised 180 to 240 hours of individual and group treatment over 6 to 8 weeks . Assessment s occurred at intake , 12 weeks after intake , and 3 and 6 months after release from prison . There were no significant differences between conditions on all key domains ( PTSD , SUD , psychopathology , and legal problems ) ; but both conditions showed significant improvements from intake to later time points on all of these outcomes across time . Secondary analyses at follow-up found trends for SS participants improving on clinician-rated PTSD symptoms and TAU participants worsening on self-reported PTSD symptoms . Also , SS demonstrated continued improvement on psychopathology at 3 and 6 months , whereas TAU did not . However , alcohol use improved more for TAU during follow-up . Satisfaction with SS was high , and a greater number of SS sessions was associated with greater improvement on PTSD and drug use . Six months after release from prison , 53 % of the women in both conditions reported a remission in PTSD . Study limitations include lack of assessment of SS outcomes at end of group treatment ; lack of blind assessment ; omission of the SS case management component ; and possible contamination between the two conditions . The complex needs of this population are discussed OBJECTIVES To describe and evaluate a pilot methadone maintenance program for heroin-dependent inmates of Las Malvinas men 's prison in San Juan , Puerto Rico . METHODS Data from self-report of inmates ' drug use before and during incarceration , attitudes about drug treatment in general and methadone maintenance in particular , and expectations about behaviors upon release from prison and from testing inmates ' urine were analyzed comparing program patients ( n=20 ) and inmates selected at r and om from the prison population ( n=40 ) . Qualitative data obtained by interviewing program staff , the correctional officers and superintendent , and commonwealth officials responsible for establishing and operating the program were analyzed to identify attitudes about methadone and program effectiveness . RESULTS Heroin use among prisoners not in treatment was common ; 58 % reported any use while incarcerated and 38 % reported use in past 30 days . All patients in the treatment program had used heroin in prison in the 30 days prior to enrolling in treatment . While in treatment , the percentage of patients not using heroin was reduced , according to both self-report and urine testing , to one in 18 ( 94 % reduction ) and one in 20 ( 95 % reduction ) , respectively . Participation in treatment was associated with an increased acceptance of methadone maintenance . Prison personnel and commonwealth officials were supportive of the program . CONCLUSIONS The program appears to be a success , and prison officials have begun an expansion from the current ceiling of 24 inmates to treat 300 or more inmates AIMS To examine the long-term impact of methadone maintenance treatment ( MMT ) on mortality , re-incarceration and hepatitis C seroconversion in imprisoned male heroin users . DESIGN , SETTING AND PARTICIPANTS The study cohort comprised 382 imprisoned male heroin users who had participated in a r and omized controlled trial of prison-based MMT in 1997/98 . Subjects were followed-up between 1998 and 2002 either in the general community or in prison . MEASUREMENTS All-cause mortality , re-incarceration , hepatitis C and HIV serostatus and MMT retention . FINDINGS There were no deaths recorded while subjects were enrolled in MMT . Seventeen subjects died while out of MMT , representing an untreated mortality rate of 2.0 per 100 person-years ( 95 % CI , 1.2 - 3.2 ) . Re-incarceration risk was lowest during MMT episodes of 8 months or longer ( adjusted hazard ratio 0.3 ( 95 % CI , 0.2 - 0.5 ; P < 0.001 ) , although MMT periods 2 months or less were associated with greatest risk of re-incarceration ( P < 0.001 ) . Increased risk of hepatitis C seroconversion was significantly associated with prison sentences of less than 2 months [ adjusted hazard ratio 20 ( 95 % CI , 5 - 76 ; < P = 0.001 ) ] and MMT episodes less than 5 months [ adjusted hazard ratio 4.2 ( 95 % CI , 1.4 - 12.6 ; P = 0.01 ) ] . Subjects were at greatest risk of MMT dropout during short prison sentences of 1 month or less ( adjusted hazard ratio 10.4 ( 95 % CI , 7.0 - 15.7 ; P < 0.001 ) . HIV incidence was 0.3 per 100 person-years ( 95 % CI , 0.03 - 0.99 ) . CONCLUSIONS Retention in MMT was associated with reduced mortality , re-incarceration rates and hepatitis C infection . Prison-based MMT programmes are integral to the continuity of treatment needed to ensure optimal outcomes for individual and public health This study examined benefits of methadone maintenance among prerelease prison inmates . Incarcerated males with preincarceration heroin dependence ( n = 197 ) were r and omly assigned to ( a ) group educational counseling ( counseling only ) ; ( b ) counseling , with opportunity to begin methadone maintenance on release ( counseling + transfer ) ; or ( c ) counseling and methadone maintenance in prison , with opportunity to continue methadone maintenance on release ( counseling + methadone ) . At 90-day follow-up , counseling + methadone participants were significantly more likely than counseling-only and counseling + transfer participants to attend drug treatment ( p = .0001 ) and less likely to be reincarcerated ( p = .019 ) . Counseling + methadone and counseling + transfer participants were significantly less likely ( all ps < .05 ) to report heroin use , cocaine use , and criminal involvement than counseling-only participants . Follow-up is needed to determine whether these findings hold over a longer period AIMS Recent studies have demonstrated the efficacy of both methadone and buprenorphine when used with opioid dependent men transitioning from prison to the community , but no studies have been conducted with women in the criminal justice ( CJ ) system . The aim of this study was to determine the efficacy of buprenorphine for relapse prevention among opioid dependent women in the CJ system transitioning back to the community . METHODS 36 women under CJ supervision were recruited from an inpatient drug treatment facility that treats CJ individuals returning back to the community . Nine were enrolled in an open label buprenorphine arm then 27 were r and omized to buprenorphine ( n=15 ) or placebo ( n=12 ; double-blind ) . All women completed baseline measures and started study medication prior to release . Participants were followed weekly , provided urine drug screens ( UDS ) , received study medication for 12 weeks , and returned for a 3-month follow-up . Intent-to-treat analyses were performed for all time points through 3 month follow-up . RESULTS The majority of participants were Caucasian ( 88.9 % ) , young ( M±SD=31.8±8.4 years ) , divorced/separated ( 59.2 % ) women with at least a high school/GED education ( M±SD=12±1.7 years ) . GEE analyses showed that buprenorphine was efficacious in maintaining abstinence across time compared to placebo . At end of treatment , 92 % of placebo and 33 % of active medication participants were positive for opiates on urine drug screen ( Chi-Square=10.9 , df=1 ; p<0.001 ) . However , by the three month follow-up point , no differences were found between the two groups , with 83 % of participants at follow-up positive for opiates . CONCLUSIONS Women in the CJ system who received buprenorphine prior to release from a treatment facility had fewer opiate positive UDS through the 12 weeks of treatment compared to women receiving placebo . Initiating buprenorphine in a controlled environment prior to release appears to be a viable strategy to reduce opiate \n Output:\n " }, { "from": "agent", "value": "Results suggest therapeutic communities are effective in reducing recidivism and , to a lesser extent substance use after release .\nThere is also evidence to suggest that opioid maintenance treatment is effective in reducing the risk of drug use after release from prison for opioid users .\nFurthermore , care after release from prison appears to enhance treatment effects for both types of interventions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND PURPOSE The efficacy of stroke units has been extensively examined . It is unknown , however , whether the superiority of the stroke unit will remain after the increased focus on stroke treatment in general medicine . This study of patients admitted to the hospital early and with a short length of stay determines the effect and identifies certain important components of a stroke unit . METHODS Five hundred fifty patients aged 60 years or older with acute stroke were allocated by a quasi-r and omized design to a stroke unit or a general medical ward based on date of birth in the month . Patients admitted within 24 hours of onset were enrolled . Outcomes after 7 months were death , proportion needing long-term care , and change in neurological and functional state assessed by the Sc and inavian Stroke Scale and Barthel Index . RESULTS Seven months after admission there was a trend in favor of the stroke unit in all outcome measures , but no significant differences in clinical outcomes were found except for change in the Sc and inavian Stroke Scale score . Recurrent stroke during hospitalization occurred more often in the general medical ward ( P = .03 ) . The stroke unit was significantly more aggressive in mobilization out of bed ( P<.01 ) and use of parenteral fluid ( P<.0001 ) , aspirin ( P<.0001 ) , antipyretics ( P<.0001 ) , and antibiotics ( P<.0001 ) . CONCLUSIONS Our study confirms the benefit of the stroke unit , but the effects on the most reliable clinical outcomes were modest and insignificant . Treatment in this stroke unit hastened recovery . More aggressive rehabilitation and use of parenteral fluid , aspirin , antipyretics , and antibiotics appeared in the stroke unit In a r and omized controlled trial we compared the clinical outcome of acute stroke patients , 110 of whom were allocated to treatment in a stroke unit and 110 to treatment in general medical wards . No significant difference existed between these groups with regard to sex , age , marital status , medical history , or functional impairment on admission . Outcome was measured at 6 and 52 weeks after the stroke by the proportion of patients at home , the proportion of patients in an institution , the mortality , and the functional state . After 6 weeks 56.4 % of the patients r and omized to the stroke unit and 32.7 % of the patients r and omized to the general medical wards were at home ( p = 0.0004 ) , and after 52 weeks 62.7 % and 44.6 % , respectively , were at home ( p = 0.002 ) . After 6 weeks 36.3 % of the patients from the stroke unit and 50.0 % from the general medical wards were in an institution ( p = 0.02 ) ; after 52 weeks 12.7 % and 22.7 % , respectively , were institutionalized ( p = 0.016 ) . After 6 weeks mortality was 7.3 % for the stroke unit group and 17.3 % for the general medical wards group ( p = 0.027 ) . After 52 weeks mortality was 24.6 % for the stroke unit group and 32.7 % for the general medical wards group ( difference not significant ) . Functional state was significantly better for patients treated in the stroke unit after both 6 and 52 weeks . We conclude that care of patients with acute stroke in a stroke unit improves clinical outcome compared with treatment in general medical wards Background and Purpose — Although several studies have demonstrated the effectiveness of specialist Stroke Unit ( SU ) care of stroke patients , there is still disagreement over how these units are best organized . We sought to clarify the role of continuous monitoring of physiological parameters in acute ischemic stroke . Methods — We conducted a prospect i ve study of 268 first-ever ischemic stroke patients admitted to our Cerebrovascular Department and allocated , according to the availability of beds , to the SU or Cerebrovascular Unit ( CU ) . Statistical analysis compared mortality and outcome at discharge , medical and neurological complications , and length of hospitalization in the 2 care setting s. Results — Two hundred sixty-eight patients were enrolled . A good outcome at discharge , observed in 114 SU patients ( 85 % ) and 78 CU patients ( 58 % ) ( odds ratio , 2.63 ; 95 % CI , 1.4 to 4.8 ; P < 0.02 ) , was found , on multivariate analysis , to be significantly related to type of care ( SU versus CU ) . A significantly greater proportion of SU patients showed adverse changes in monitored parameters , which required acute medical treatment ( SU : 64 % ; CU : 19 % ; P < 0.0001 ) . The mean duration of these complications was significantly shorter in the SU patients ( SU : 1.0 day ; CU : 2.4 days ; P < 0.02 ) , and the outcome in patients experiencing complications covered by the monitoring protocol was significantly better in the SU ( 66 % ) than in the CU ( 35 % ) group ( P < 0.0001 ) . Conclusions — Admission of acute stroke patients to a monitoring SU may positively influence their outcome at discharge . Confirmation of our findings in larger trials will indicate the need for a revision of the minimum requirements of SUs , with the addition of monitoring as a new requirement Abstract Hemiplegic patients with an average age of 65 years , were r and omly assigned to a rehabilitation center ( the control group ) and to a general hospital under the management of a nurse trained in rehabilitation procedures ( the experimental group ) . Patients with severe impairment and aphasia were excluded . The two groups were similar in age , sex , residence accommodation prior to rehabilitation , duration of disability , degree of proficiency in self-care , intelligence , degree of perceptual motor deterioration , and available ‘ ego energy . ’ Minor differences between the two groups are discusssed in detail with reference to their effect on outcome . Improvement in living arrangements and self-care were effected equally by the rehabilitation team and rehabilitation nurse . In locomotion the experimental group did not do as well as the control group . The rehabilitation nurse demonstrated ability to manage the restorative care of hemiplegic patients , but severe grade s of disability require the rehabilitation center . The problems are discussed in respect to rating functional capacity in disability Background and Purpose — Pathophysiological considerations and observational studies indicate that elevated body temperature , hypoxia , hypotension , and cardiac arrhythmias in the acute phase of ischemic stroke may aggravate brain damage and worsen outcome . Methods — Both units were organized with the same st and ard care and multidisciplinary approach to nursing and rehabilitation . A blinded observer assessed functional outcome at 3 months with the modified Rankin scale ( mRS ) and Barthel Index ( BI ) . End points were ( 1 ) poor outcome , defined as either mRS ≥4 or BI < 60 or the need for institutional care and ( 2 ) mortality . Results — Fifty-four patients meeting the inclusion criteria were r and omized . The groups were well matched for baseline characteristics , stroke subtype , stroke severity , vascular risk factors , and prognostic factors . Poor outcome was seen in 7 ( 25.9 % ) patients in the SCMU group and in 13 ( 48.1 % ) in the SU group ( P = 0.16 ) . Mortality was lower in the SCMU group than in the SU group ( 1 [ 3.7 % ] vs 7 [ 25.9 % ] ; odds ratio , 0.11 [ 95 % CI , 0.02 to 0.96 ] , P = 0.05 ) . Conclusions — This pilot study suggests that admission of acute stroke patients to an SCMU may reduce mortality and poor outcome . A larger trial is required to confirm these findings Of the 373 stroke patients 95 were admitted to the feasibility study of stroke rehabilitation . The patients were divided into two groups , an intensive and a normal treatment group . In this study , the functional recovery of stroke , measured by ADL and motor function was significantly better in the intensive treatment group . There was no difference in institutionalization or incidence of death between the groups . The gain of ADL and motor function was greatest during the first three months after stroke in the intensive treatment group . The conclusion is that intensified physiotherapy seems to improve the functional recovery of stroke patients A r and omized controlled trial was conducted to examine the effects of interdisciplinary team care on acute hospitalized stroke patients . After obtaining baseline information on 42 stroke victims receiving conventional care in a general hospital , 130 stroke patients were stratified and r and omly assigned either to Traditional or Team care . Assessment s by independent evaluators permitted comparisons between Team and Traditional groups with reference to patient survival , motor performance and functional abili- ties . Data obtained prospect ively from charts and treatment logs allowed the care process across groups to be compared . Results demonstrated that Team and Traditional patients fared similarly in survival . How- ever there was an unexpected difference in survival depending upon sex . For motor performance , male survivors performed better with Team care and female survivors with the Traditional method . In terms of functional abilities , male patients receiving Team care again performed better than their Traditional counterparts , whereas in women there was no difference between the treatment groups . Stroke Vol 15 , No 5 , Background and Purpose Assessment of stroke rehabilitation is complicated by the heterogeneity of patients and setting s and by difficulties in disentangling effects of organization from effects of types and amounts of treatment input . Methods A prospect i ve controlled study was undertaken in 245 stroke patients stratified into three groups according to prognosis and managed on a stroke rehabilitation unit ( n=124 ) or general medical wards ( n=121 ) . Patients were r and omly allocated to either setting 2 weeks after stroke and were comparable for baseline characteristics . Results Patients on general medical wards received more physiotherapy on average ( 16.2 ± 7.2 versus 14.3 ± 3.2 hours ; P < .05 ) but similar amounts of occupational therapy ( 9.3 ± 2.8 versus 9.5 ± 3.2 hours ) compared with stroke unit patients . More time was spent on individual rehabilitation on the stroke unit compared with general wards ( P < .001 ) . Functional abilities at discharge , destination of discharge , and length of hospital stay in patients with good prognosis were comparable in both setting s. Patients with poor prognosis managed on general wards showed higher mortality ( P < .05 ) and longer hospital stay ( 123.2 ± 48.2 versus 52.3 ± 19.8 days ; P < .001 ) , but functional abilities at discharge in survivors were comparable with those of stroke unit patients . Patients with intermediate prognosis had significantly better outcome on the stroke unit , with more patients being discharged home ( 75 % versus 52 % ; P < .001 ) , shorter average length of hospital stay ( 48.7 ± 17.2 versus 104.6 ± 28.6 days ; P < .001 ) , and better functional abilities at discharge ( P < .05 ) . Conclusions Stroke units improve outcome and reduce hospital stay without increasing therapy time . Their effectiveness may be enhanced by patient selection In S.E. Kent , during 1978 and 1979 , 225 patients , representing 228 occurrences of hemiplegia , were referred to a new 20-bed stroke rehabilitation ward . These patients were r and omly allocated to treatment in the special ward ( group A 112 strokes ) or to remain in conventional treatment locations ( group C 116 strokes ) ; the two groups were closely similar , except for the initial level of consciousness . Survivors were observed at four-month intervals to one year . There are indications of benefit for patients in group A by comparison with Group C in terms of treatment received ( number treated by remedial therapists , the extent of treatment , and the arrangements for after-care ) , and in outcome ( survival and the proportion returned to the community ) . The direction of the trend of advantage is consistent with another recent controlled trial , although not all modes of improvement are identical in the two trials . It is suggested that every health district should develop a comprehensive policy of stroke management Follow-up of a controlled trial of the management of acute stroke in the elderly showed that the improvement in functional outcome at the time of discharge from hospital that had been achieved through establishing a stroke unit had disappeared by one year . Factors that might have contributed to this included overprotection by the families of patients who had been treated in the stroke unit , who were not permitted to carry out activities of daily living in which they were independent , and the early discharge from medical units of patients whose full rehabilitation potential had not been realised . Prolonging the benefits of short-term gains in functional outcome through the intervention of a stroke unit requires that all the links in the chain of stroke rehabilitation are maintained , including the proper orientation of patients ' families before discharge from hospital BACKGROUND Stroke unit is the most effective treatment method to benefit stroke patients . Our study is to evaluate the early effectiveness of a hospital stroke unit ( SU ) . METHODS Three hundred and ninety-two patients who had suffered from acute strokes and who were admitted to our hospital between December 2001 and January 2003 were recruited for this controlled study . All patients were sent at r and om to either the SU or the general ward ( GW ) for treatment . The following indices were measured by : Barthel Index ( BI ) , National Institute of Health Stroke Scale ( NIHSS ) , Oxford H and icap Scale ( OHS ) . RESULTS The mean change in BI score between the day of admission and the day of discharge was 20.00 + /- 24.36 for the SU group and 10.63 + /- 23.59 for the GW group . A difference that is statistically significant ( P = 0.000 ) . The mean change in NIHSS score was -2.01 + /- 6.61 for the SU group and 0.55 + /- 7.44 for the GW group . A difference that is also statistically significant ( P = 0. \n Output:\n " }, { "from": "agent", "value": "There were no significant differences in cardiovascular , physiological , or other complications .\nCONCLUSIONS Organized inpatient ( stroke unit ) care appears to reduce the risk of death after stroke through the prevention and treatment of complications , in particular infections" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Analyzing drop out rates and when they occur may give important information about the patient characteristics and trial characteristics that affect the overall uptake of an intervention . Methods We search ed Medline and the Cochrane library from the beginning of the data bases to May 2006 for published systematic review s that compared the effects of self-monitoring ( self-testing ) or self-management ( self-testing and self-dosage ) of oral anticoagulation or self-monitored blood glucose in type 2 diabetics who were not using insulin . We assessed all study withdrawals pre-r and omization and post r and omization and sought information on the reasons for discontinuation of all participants .To measure the differential between groups in attrition we used the relative attrition ( RA ) , which is equivalent to relative risk but uses attrition as the outcome ( i.e. attrition in intervention group/attrition in control group ) . We determined the percentage drop outs for control and intervention groups and used DerSimonian and Laird r and om effects models to estimate a pooled relative attrition . L'abbe type plots created in R ( version 2.0.2 ) were used to represent the difference in the relative attrition among the trials with 95 % confidence areas and weights derived from the r and om effects model . Results With self-monitoring of blood glucose in type 2 diabetes , attrition ranged from 2.3 % to 50.0 % in the intervention groups and 0 % to 40.4 % in the control groups . There was no significant difference between the intervention and control , with an overall RA of 1.18 [ 95 % CI , 0.70–2.01 ] . With self-monitoring of oral anticoagulation attrition ranged from 0 % to 43.2 % in the intervention groups and 0 % to 21.4 % in the control group . The RA was significantly greater in the intervention group , combined RA , 6.05 [ 95 % CI , 2.53–14.49 ] . Conclusion This paper demonstrates the use of relative attrition as a new tool in systematic review methodology which has the potential to identify patient , intervention and trial characteristics which influences attrition in trials The CONSORT ( Consoli date d St and ards of Reporting Trials ) statement is used worldwide to improve the reporting of r and omized , controlled trials . Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . R and omised trials are at the heart of evidence -based healthcare , but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free . Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and , in doing so , to improve trial efficiency . This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative . We first outline the problem of inefficiency in r and omised trials and go on to describe Trial Forge . We present participants ’ views on the processes in the life of a r and omised trial that should be covered by Trial Forge . General support existed at the workshop for the Trial Forge approach to increase the evidence base for making r and omised trial decisions and for improving trial efficiency . Agreed upon key processes included choosing the right research question ; logistical planning for delivery , training of staff , recruitment , and retention ; data management and dissemination ; and close down . The process of linking to existing initiatives where possible was considered crucial . Trial Forge will not be a guideline or a checklist but a ‘ go to ’ website for research on r and omised trials methods , with a linked programme of applied methodology research , coupled to an effective evidence -dissemination process . Moreover , it will support an informal network of interested trialists who meet virtually ( online ) and occasionally in person to build capacity and knowledge in the design and conduct of efficient r and omised trials . Some of the re sources invested in r and omised trials are wasted because of limited evidence upon which to base many aspects of design , conduct , analysis , and reporting of clinical trials . Trial Forge will help to address this lack of evidence PURPOSE / OBJECTIVES To develop the Meaning of Life Intervention in response to the need for brief and meaning-focused interventions in palliative care and to establish potential effect sizes for future full-scale r and omized , controlled trials . DESIGN A r and omized , controlled trial conducted to pilot test the Meaning of Life Intervention . SETTING A 68-bed oncology inpatient ward in an urban acute general hospital in Hong Kong . SAMPLE 84 patients with advanced-stage cancer . Fifty-eight completed the study . METHODS Assessment s of outcome variables were conducted at baseline and one day and two weeks after the intervention . Patients were r and omly allocated to the intervention group or the control group . Repeated measures analysis of covariance were conducted to assess the impact of the Meaning of Life Intervention on participants ' quality of life . MAIN RESEARCH VARIABLES The primary outcome was quality of life and was measured by the Quality -of-Life Concerns in the End-of-Life ( QOLC-E ) question naire and with a single-item scale on global quality of life . The eight subscales of the QOLC-E served as secondary outcomes . FINDINGS Statistically significant main effects were noted for the group in the QOLC-E question naire total score , the single-item scale on global quality of life , and the existential distress subscale of the QOLC-E question naire . The effects represented a medium effect size . CONCLUSIONS The results of this pilot study show that the Meaning of Life Intervention can improve quality of life , particularly existential distress . IMPLICATION S FOR NURSING The Meaning of Life Intervention represents a potentially effective and efficient intervention that is feasible for implementation by nursing staff for patients with advanced-stage cancer in a palliative care setting Diverse analysis approaches have been proposed to distinguish data missing due to death from nonresponse , and to summarize trajectories of longitudinal data truncated by death . We demonstrate how these analysis approaches arise from factorizations of the distribution of longitudinal data and survival information . Models are illustrated using cognitive functioning data for older adults . For unconditional models , deaths do not occur , deaths are independent of the longitudinal response , or the unconditional longitudinal response is averaged over the survival distribution . Unconditional models , such as r and om effects models fit to unbalanced data , may implicitly impute data beyond the time of death . Fully conditional models stratify the longitudinal response trajectory by time of death . Fully conditional models are effective for describing individual trajectories , in terms of either aging ( age , or years from baseline ) or dying ( years from death ) . Causal models ( principal stratification ) as currently applied are fully conditional models , since group differences at one timepoint are described for a cohort that will survive past a later timepoint . Partly conditional models summarize the longitudinal response in the dynamic cohort of survivors . Partly conditional models are serial cross-sectional snapshots of the response , reflecting the average response in survivors at a given timepoint rather than individual trajectories . Joint models of survival and longitudinal response describe the evolving health status of the entire cohort . Research ers using longitudinal data should consider which method of accommodating deaths is consistent with research aims , and use analysis methods accordingly An innovative non-pharmacological intervention called Voix d'Or ( ® ) ( Golden Voice ) was proposed in the Cognitive behavioral unit ( CBU ) of the Memory center at the Hospices civils in Lyon . Voix d'Or ( ® ) offers eight sound activities disseminated via an audio device based on different approaches sociotherapeutic ( music therapy , reminiscence , relaxation , reorientation in reality ) . The aim of this study was to test the effects of the Voix d'Or ( ® ) program on behavioral and psychological symptoms of dementia ( BPSD ) in patients with Alzheimer 's disease hospitalized in the CBU . Twenty four patients with agitation and /or apathy and /or anxiety and /or depression were included . Patients were r and omly selected in the intervention group exposed to Voix d'Or versus a control group exposed to usual occupational activities . Patients were assessed before ( T0 ) and after ( T1 ) the intervention period . Several variables were measured : frequency and severity of behavioral disorders , anxiety , depression , agitation and apathy . A significant improvement of anxiety level between T0 and T1was observed in the group with Voix d'Or ( ® ) compared to the control group . This study suggests that this non-pharmacological intervention may be beneficial on anxiety in patients with Alzheimer 's disease BACKGROUND AND OBJECTIVE R and omization does not protect against bias due to missing observations . In addition , different reasons for missing observations may lead to different invalid results . The purpose of this study was to illustrate how r and omized intervention studies can be threatened by bias due to missing observations because of death or nonresponse . METHODS A r and omized clinical trial of the effect of psychosocial intervention on well-being after an operation for colorectal cancer was conducted in Denmark . Patients were interviewed 3 , 6 , 12 , and 24 months after discharge from hospital . RESULTS We found that the probability of nonresponse decreased with increasing anxiety score in the intervention group , but it increased with increasing anxiety score in the control group . This could lead to severe bias in an analysis of the effect of intervention on anxiety . Low physical functioning and low global health status and quality of life were related to an increased probability of dying before the next follow-up , and this association could explain the associations between anxiety and depression , respectively , and the probability of dying observed in crude analyses . CONCLUSION Our study emphasizes the importance of performing specific missing data analyses in any study of well-being variables Intention-to-treat ( ITT ) analyses are the st and ard way to evaluate r and omized controlled trials ( RCTs ) to minimize Type I errors related to differential rates of noncompletion from one study arm . People in palliative care often die sooner than predicted as a direct result of disease progression , some of whom will be participating in RCTs and who will , therefore , withdraw or die after r and omization for reasons unrelated to the intervention . This proportion of withdrawals is statistically negligible in other clinical disciplines , but commonplace in hospice/palliative care , creating a systematic bias away from the true effect . ITT analyses in hospice/palliative care that deem all withdrawals to be treatment failures or that impute data from deteriorating participants systematic ally underestimate the benefits of interventions , reducing the power of these studies . Equally unacceptable would be a per protocol analysis that excludes all withdrawals after r and omization as this will underestimate toxicity . A modified analytic approach is needed on a continuum between ITT and per protocol analyses . To address data after r and omization where there is a high rate of withdrawals because of death or deterioration , criteria need to include being : 1 ) prespecified in the original protocol ; 2 ) clinical ly absolutely the result of disease progression ; 3 ) identified by the blinded Independent Data Monitoring Committee as being unrelated to the intervention(s ) ; and 4 ) accounted for in the study 's CONSORT diagram . Such data should not be included in the analysis of the primary outcome . This article aims to define a better way of balancing Type I and Type II errors in hospice/palliative care RCT analyses using the palliative-modified ITT analysis . Arguably , the palliative-modified ITT analysis should be the primary evaluation of hospice/palliative care Phase III studies but , as a minimum , should routinely be the key sensitivity analysis BACKGROUND AND STUDY AIMS There are limited data on the role of antireflux biliary stents . This single-center r and omized trial compared the endoscopic use of partly covered antireflux metal stents ( pcARMS ) with that of st and ard uncovered self-exp and able metal stents ( ucSEMS ) for the palliation of nonhilar malignant biliary obstruction . PATIENTS AND METHODS Between August 2007 and February 2012 , patients with nonhilar malignant biliary obstruction were r and omly assigned to treatment with either pcARMS or ucSEMS . Subsequent follow-up was conducted in clinic or by phone . The primary outcome was onset of cholangitis within 12 months of stenting . Secondary outcomes included other morbidities , stent dysfunctions , and survival . RESULTS Altogether 112 patients were included , 56 in each group . The stents were successfully deployed in all patients . Satisfactory jaundice control was achieved in 49 cases in the pcARMS group , compared with 47 in the ucSEMS group ( P = 0.135 ) . Fewer patients experienced cholangitis in the pcARMS group than in the ucSEMS group ( 10 vs. 21 patients ; P = 0.035 ) , and the frequency of episodes was less ( P = 0.022 ) . Respectively , 17 and 29 stent dysfunctions before death were observed in the pcARMS and ucSEMS groups ( P = 0.051 ) and the median stent patency was 13.0 ( st and ard deviation [ SD ] 3.4 ) and 10.0 ( 1.2 ) months , respectively ( P = 0.044 ) . At final follow-up , in January 2013 , 50 /52 and 52 /55 patients had died and no difference in median survival was seen between the two groups ( 8.0 vs. 9.0 months , P = 0.56 ) . CONCLUSIONS Stenting with pcARMS compared with st and ard ucSEMS reduces risk of ascending cholangitis and has longer stent patency , but does not increase patient survival . Chictr.org . number , ChiCTR-TRC-11001800 Background and Goals : Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction ( MBDO ) . However , it can cause complications and requires periodic stent exchanges \n Output:\n " }, { "from": "agent", "value": "Conclusion The overall proportion and differential rates and reasons for MD reduce the power and potentially introduce bias to palliative care trials" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Whether asthma morbidity in minority groups can be reduced by preventative health care measures delivered in the relevant ethnic dialects requires further evaluation . This study reports clinical outcomes and quality of life from a community based project investigating white European ( W/E ) and Indian subcontinent ( ISC ) ethnic groups with asthma living in deprived inner city areas of Birmingham , UK . METHODS Six hundred and eighty nine asthmatic subjects ( 345 W/E , 344 ISC ) of mean ( SD ) age 34.5 ( 15 ) years ( range 11–59 ) and mean forced expiratory volume in one second ( FEV1 ) of 80 % predicted were interviewed in English , Punjabi , Hindi , or Urdu . Subjects r and omised to the active limb of a prospect i ve , open , r and omised , controlled , parallel group , 12 month follow up study underwent individually based asthma education and optimisation of drug therapy with four monthly follow up ( active intervention ) . Control groups were seen only at the beginning and end of the study . Urgent or emergency interactions with primary and secondary health care ( clinical outcomes ) and both cross sectional and longitudinal data from an Asthma Quality of Life Question naire ( AQLQ ) were analysed . RESULTS Clinical outcomes were available for 593 subjects . Fewer of the active intervention group consulted their GP ( 41.8 % versus 57.8 % , odds ratio ( OR ) 0.52 ( 95 % CI 0.37 to 0.74 ) ) or were prescribed antibiotics ( 34.9 % versus 51.2 % , OR 0.51 ( 95 % CI 0.36 to 0.72 ) ) , but by ethnicity statistically significant changes occurred only in the W/E group with fewer also attending A&E departments and requiring urgent home visits . Active intervention reduced the number of hospital admissions ( 10 versus 30 ) , GP consultations ( 341 versus 476 ) , prescriptions of rescue oral steroids ( 92 versus 177 ) , and antibiotics ( 220 versus 340 ) , but again significant improvements by ethnicity only occurred in the active W/E group . AQLQ scores were negatively skewed to the higher values ; regression analysis showed that lower values were associated with ISC ethnicity . Longitudinal changes ( for 522 subjects ) in the mean AQLQ scores were small but statistically significant for both ethnic groups , with scores improving in the active and worsening in the control groups . CONCLUSIONS Active intervention only improved clinical outcomes in the W/E group . AQLQ scores , although lower in the ISC group , were improved by active intervention in both ethnic groups A prospect i ve r and omised trial was performed to evaluate the effectiveness of an asthma education programme administered by an asthma nurse specialist in an out-patient setting . Sixty asthmatic patients ( mean age 28.5 years ) were enrolled , 30 to a usual care control group and 30 to an education group . The education group underwent an individual education programme lasting at least one hour . The following variables were measured at baseline , one month after the education programme and at one year follow-up : asthma knowledge by MCQ ( 36 point question naire ) , inhaler technique ( 7 point scale ) , peak expiratory flow rate ( PEFR ) and symptomatology by visual analogue score ( 0 to 10 score ) . The education group 's inhaler technique and MCQ score both improved significantly at one month , from 5.4 ( 0.3 ) ( mean [ SEM ] ) to 6.5 ( 0.3 ) , p < 0.001 , and from 7.5 ( 2.4 ) to 22 ( 1.8 ) , p < 0.0001 respectively . Both of these improvements were significantly greater than in the control group , and both were maintained at one year follow-up . The symptom score improved over one year in the education group , from 5.4 ( 0.6 ) to 7.6 ( 0.5 ) , p < 0.05 , and was unchanged in the control group . There was no change in the PEFR in either group . This study shows clear objective benefits to an out-patient asthma education programme conducted by an asthma nurse specialist The purpose was to compare the short-term cost-effectiveness of intensive vs conventional education and supervision for the self-management of mild asthmatic patients . Consecutive newly diagnosed asthmatic patients ( n = 162 ) were r and omized into an intervention group ( IG ) and a control group ( CG ) with 1 yr of treatment and follow-up . Intensive education was given to 77 patients at visits every third month in the outpatient clinic . Eighty CG patients received conventional education and advice at the baseline visit only . All patients received similar inhaled anti-inflammatory treatment . At baseline and at 12 months st and ard clinical lung functions and health-related quality of life ( HRQOL ) were measured , the latter by the disease-specific St George 's Respiratory Question naire and the generic 15D . Furthermore , the use of extra health care services , medication and sickness days were recorded . The IG experienced a significant improvement in all clinical and HRQOL outcome variables . The same applied to the CG except spirometric values . The groups differed significantly only in terms of FEV1 ( P < 0.05 ) in favour of the IG . There was a significant difference between the groups in extra costs . The mean cost was FIM 2351 per patient ( 294 Pounds sterling ) in the CG and FIM 2757 per patient ( 345 Pounds ) in the IG , of which the intervention cost was FIM 1978 per patient ( 247 Pounds ) . In 1 yr follow-up the intensive education programme did not prove to be cost effective but was dominated by the conventional one regardless of what effectiveness measure was used . Also , a purely monetary cost-benefit calculation showed that the intervention result ed in a negative net benefit ( loss ) of FIM 406 per patient ( 51 Pounds ) . A longer follow-up may be needed before definitive conclusions about the cost-effectiveness of this kind of intervention can be drawn The effects on self management of asthma of a specially prepared book and audiocassette tape with similar contents were observed in a controlled study of 177 patients with asthma in general practice . After a run in period of six months patients were r and omly given the book , the tape , both the book and tape , or neither . Patients ' knowledge of the use of drugs , perceptions of their disability , skill in using an inhaler , consumption of drugs , consultations with their general practitioners , morbidity ( from patients ' entries on diary cards ) , and use of the educational material were measured . Knowledge about the use of drugs was significantly increased in the groups who received the material after three months and persisted after 12 months . Patients who had been given the tape or the book and tape increased their scores of knowledge of drugs more than patients given the book alone . Patients in all groups given the material considered that their disability was reduced . There were no other significant changes . Patients given both the book and the tape preferred the book . Patients with asthma can obtain useful information from such material . The paradoxical result whereby patients learnt more from the tape but preferred the book suggests that a distinction can be made between information that patients need , which may be acquired better from an audiocassette , and information that they want , which may be acquired better from a book BACKGROUND Many patients with asthma or chronic obstructive pulmonary disease use their medication inhalers incorrectly . General practitioners , pharmacists and other health care providers do not always have the opportunity to instruct patients in correct inhaler technique . OBJECTIVE To find out whether the inhaler technique and respiratory symptoms of patients can be improved after instruction by practice assistants . METHODS Single blind , r and omized intervention study in which 48 patients who had been using a dry powder inhaler for at least one month took part . Their inhaler technique was videotaped on two visits with a two-week interval between visits . The inhaler technique on the videos was subsequently scored by two experts on nine criteria . At both visits the patients completed a question naire about their respiratory symptoms . After the first video , 25 patients were r and omly chosen to receive instruction from one of six practice assistants who had followed a one evening course about inhaler instruction , and who had been issued an instruction-set . RESULTS The patients who received instruction had a significantly greater reduction in number of mistakes at the second visit than the patients who did not ( P = 0.01 ) . The instructed patients also reported less dyspnoea at the second visit ( P = 0.03 ) . No effect of instruction was found on wheezing , cough and sputum production . CONCLUSION The inhaler technique of patients can be improved significantly by the instruction of patients by trained practice assistants , possibly result ing in less dyspnoea Abstract Objectives : To evaluate the effectiveness of an asthma re source centre in improving treatment and quality of life for asthmatic patients Design : Community based r and omised controlled trial Setting : 41 general practice s in Greenwich with a practice nurse Subjects : All registered patients aged 15 - 50 years Intervention : Nurse specialists in asthma who educated and supported practice nurses , who in turn educated patients in the management of asthma according to the British Thoracic Society 's guidelines Main outcome measures : Quality of life of asthmatic patients , attendance at accident and emergency departments , admissions to local hospitals , and steroid prescribing by general practitioners Results : Of 24 400 patients r and omly selected and surveyed in 1993 , 12 238 replied ; 1621 were asthmatic of whom 1291 were sent a repeat question naire in 1996 and 780 replied . Of 24 400 patients newly surveyed in 1996 , 10 783 ( 1616 asthmatic ) replied . No evidence was found for an improvement in asthma related quality of life among newly surveyed patients in intervention practice s compared with control practice s. Neither was there evidence of an improvement in other measures of the quality of asthma care . Weak evidence was found for an improvement in quality of life in intervention practice s among asthmatics registered with study practice s in 1993 and followed up in 1996 . Neither attendances at accident and emergency departments nor admissions for asthma showed any tendency to diverge in intervention and control practice s over the study period . Steroid prescribing rates rose steadily during the study period . The average annual increase in steroid prescribing was 3 % per year higher in intervention than control practice s ( 95 % confidence interval −1 % to 6 % , P=0.10 ) Conclusions : This model of service delivery is not effective in improving the outcome of asthma in the community . Further development is required if cost effective management of asthma is to be BACKGROUND Despite improved underst and ing of the pathophysiology of asthma , morbidity and mortality continue to rise , with disproportionate increases occurring among urban , indigent minorities . New approaches in the management of asthma are therefore necessary to reverse these dramatic and costly trends . OBJECTIVE To determine if patients who are admitted to the hospital with acute asthma and receive inpatient education will have improved outpatient follow-up and clinical outcome measures compared with those receiving conventional care . METHODS Patients enrolled in the study had a primary admission diagnosis of asthma and were between ages 18 and 45 years . Exclusion criteria included comorbid disease , inability to speak English , absence of a telephone in the primary residence , or pregnancy . Seventy-seven patients admitted from the emergency department with asthma were r and omized to either the inpatient educational program ( IEP ) or routine care ( control group ) . Patients in the IEP received asthma education , bedside spirometry , a telephone call 24 hours after discharge , and scheduled follow-up in an outpatient asthma program within 1 week of discharge . Those individuals r and omized to the routine management group received conventional inpatient asthma care and routine follow-up . RESULTS The patients enrolled in the IEP had a markedly higher follow-up rate compared with outpatient appointments ( 60 % vs. 27 % ; P = .01 ) and significantly fewer emergency department visits ( P = .04 ) and hospitalizations ( P = .04 ) for asthma in the 6 months following IEP intervention , as compared with control patients . This represented a substantial cost savings to the managed care organization . CONCLUSION Our study suggests that an IEP in the treatment of indigent , inner-city patients hospitalized with asthma reduces the need for subsequent emergent care and improves outpatient follow-up in a cost-effective manner A prospect i ve controlled trial of home monitoring of peak expiratory flow rate ( PEFR ) was conducted to determine the usefulness of an objective measure of lung function in association with an education program and a medication self-management plan in reducing morbidity in adult patients with asthma . Thirty-five patients managed themselves , using peak flow readings as the basis for the therapeutic plan coupled with educational intervention , whereas 35 control patients used symptoms and spirometric data for following physicians ' treatment plans . After a 6-mo study period , patients in the experimental group showed statistically significant improvements in morbidity parameters ( days lost from work , acute asthma attacks , days on antibiotic therapy , physician consultations , and emergency room admissions for asthma ) , increases in FVC , FEV1 , and FEV1/FVC , mean PEFR and mean morning PEFR , decrease in percentage of the mean PEFR amplitude , and a reduction in the use of inhaled beta-agonists , oral theophylline , and oral prednisone . Although improvements in some of these parameters were also found in the control group , they did not reach the levels of significance obtained in the experimental group . The personal use of an objective measure of lung function in association with a medication self-management plan leads to improvement in the patient 's condition BACKGROUND Although patient education is \n Output:\n " }, { "from": "agent", "value": "Measures of lung function were little changed .\nREVIEW ER 'S CONCLUSIONS Education in asthma self-management which involves self-monitoring by either peak expiratory flow or symptoms , coupled with regular medical review and a written action plan improves health outcomes for adults with asthma .\nTraining programmes that enable people to adjust their medication using a written action plan appear to be more effective than other forms of asthma self-management" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE Athletes often use weight training to prepare for sprint events , but the effectiveness of different types of weight training for sprinting is unclear . We have therefore investigated the effect of slow and explosive weight training on kayak sprint performance . METHODS Twenty-seven male and 11 female experienced sprint kayakers were r and omized to slow weight training , explosive weight training , or control ( usual training ) groups . Weight training consisted of two sessions per week for 6 wk ; in each session the athletes performed 3 - 4 sets of two sport-specific exercises with a load of 80 % 1-repetition-maximum . The two training programs differed only in the time taken to complete the concentric phase of the exercises : slow , 1.7 s ; explosive , < 0.85 s. To determine the effects of training on sprint acceleration and speed maintenance , the athletes performed 15-m kayaking sprints pre- and posttraining ; an electronic timing system provided sprint times at 3.75- , 7.5- , and 15-m marks . RESULTS Relative to control , both types of weight training substantially improved strength and sprint performance . The improvements in mean sprint time over 15 m in each group were : slow , 3.4 % ; explosive , 2.3 % ; control , -0.2 % ( 90 % confidence limits for pairwise differences , approximately + /-1.4 % ) . Over the first 3.75 m , the improvements were : slow , 7.1 % ; explosive , 3.2 % ; control , 1.4 % ( approximately + /-2.6 % ) . Over the last 7.5 m , the improvements were : slow , 2.1 % ; explosive , 3.0 % ; control , -0.8 % ( approximately + /-1.9 % ) . CONCLUSIONS Slow weight training is likely to be more effective than explosive training for improving the acceleration phase of sprinting , when force is high throughout the length of the stroke . Explosive weight training may be more effective in speed maintenance , when forces are developed rapidly over a short period at the start of the stroke Sayers , SP and Gibson , K. A comparison of high-speed power training and traditional slow-speed resistance training in older men and women . J Strength Cond Res 24(12 ) : 3369 - 3380 , 2010-Muscle power , the product of force × velocity , is a critical determinant of function in older adults . Resistance training ( RT ) at high speed has been shown to improve peak muscle power in this population ; however , different functional tasks may benefit from the improvement of power at values other than “ peak ” values , for example , tasks that require a greater velocity component or a greater force component . This study compared the effect of high-speed RT on muscle performance ( peak power [ PP ] and its components [ PP force and PP velocity ] and overall peak velocity [ VEL ] ) across a broad range of external resistances . Thirty-eight older men and women were r and omized to high-speed power training at 40 % of the 1-repetition maximum ( 1RM ) ( n = 13 [ 74.1 ± 6.4 years ] ) ; traditional RT at 80 % 1RM ( n = 13 [ 70.1 ± 7.0 years ] ) ; or control ( n = 12 [ 72.8 ± 4.1 years ] ) . Measures of muscle performance were obtained at baseline and after the 12-week training intervention . Muscle power and 1RM strength improved similarly with both high-speed and traditional slow-speed RT . However , speed-related muscle performance characteristics , PP velocity and overall VEL , were most positively impacted by high-speed power training , especially at lower external resistances . Because gains in speed-related measures with high-speed training compared to traditional RT do not come at the expense of other muscle performance outcomes , we recommend using an RT protocol in older adults that emphasizes high-speed movements at low external resistances OBJECTIVE To determine the effect of training intensity on the contributions of force and velocity to improvements in peak power ( PP ) after explosive resistance training in older adults . METHODS 112 healthy older adults ( 69 + /- 6 yr ) were r and omized to explosive resistance training at 20 % ( G20 ) , 50 % ( G50 ) , or 80 % ( G80 ) maximal strength ( 1-repetition maximum ) for 8 - 12 wk ( twice weekly , 5 exercises , 3 sets of 8 explosive concentric/slow eccentric repetitions ) using pneumatic resistance machines or a nontraining control group ( CON ) . RESULTS Force at peak power ( FPP ) increased significantly and similarly among training groups compared with CON . Velocity at peak power ( VPP ) did not improve significantly and remained similar between all groups . Force contributed significantly more to PP production in G80 and G50 than in CON . The change in PP was independently predicted by changes in fat-free mass in G80 and by changes in both FPP and VPP in G50 and G20 . CONCLUSION Explosive resistance training in older adults results in the ability to produce higher PP outputs with heavier loads without loss of movement velocity . Moderate- to high-intensity training induced a greater relative contribution of force to PP production in this cohort The purpose of this investigation was to examine the effect of an 8-week training program with heavy- vs. light-load jump squats on various physical performance measures and electromyography ( EMG ) . Twenty-six athletic men with varying levels of resistance training experience performed sessions of jump squats with either 30 % ( JS30 , n = 9 ) or 80 % ( JS80 , n = 10 ) of their one repetition maximum in the squat ( 1RM ) or served as a control ( C , n = 7 ) . An agility test , 20-m sprint , and jump squats with 30 % ( 30J ) , 55 % ( 55J ) , and 80 % ( 80J ) of their 1RM were performed before and after training . Peak force , peak velocity ( PV ) , peak power ( PP ) , jump height , and average EMG ( concentric phase ) were calculated for the jumps . There were significant increases in PP and PV in the 30J , 55J , and 80J for the JS30 group ( p < 0.05 ) . The JS30 group also significantly increased in the 1RM with a trend towards improved 20-m sprint times . In contrast , the JS80 group significantly increased both PF and PP in the 55J and 80J and significantly increased in the 1RM but ran significantly slower in the 20-m sprint . In the 30J the JS30 group 's percentage increase in EMG activity was significantly different from the C group . In the 80J the JS80 group 's percentage increase in EMG activity was significantly different from the C group . This investigation indicates that training with light-load jump squats results in increased movement velocity capabilities and that velocity-specific changes in muscle activity may play a key role in this adaptation The authors investigated the effects of low-intensity resistance training on muscle size and strength in older men and women . Thirty-five participants ( age 59 - 76 yr ) were r and omly assigned to 2 groups and performed low-intensity ( 50 % of 1-repetition maximum ) knee-extension and -flexion exercises with either slow movement and tonic force generation ( LST ; 3-s eccentric , 3-s concentric , and 1-s isometric actions with no rest between repetitions ) or normal speed ( LN ; 1-s concentric and 1-s eccentric actions with 1-s rests between repetitions ) twice a week for 12 wk ( 2-wk preparation and 10-wk intervention ) . The LST significantly increased thigh-muscle thickness , as well as isometric knee-extension and -flexion strength . The LN significantly improved strength , but its hypertrophic effect was limited . These results indicate that even for older individuals , the LST can be an effective method for gaining muscle mass and strength Initial strength gains were examined in the context of learning a new skill . Forty female volunteers were r and omly assigned to one of four groups : a bench-press training group utilizing heavy loads in its training , a bench-press training group utilizing almost no load , an alternative training group using different exercises , or a control group that did not train . Training period was 6 wk , with three training sessions per week . Emphasis was put on keeping the coordination and muscular adaptation dem and s in the bench-press groups as invariant as possible . Bench-press training with a light or with a heavy weight was shown to be equally effective in improving the maximal velocity of contraction for a given absolute resistance . Mean velocity with loads of 0.37 , 6.6 , 16.6 , and 20 kg improved by 21.1 , 15.8 , 16.9 , and 19.5 % , respectively . No significant differences in the percent improvement at the four different loads were apparent , indicating that no significant velocity-specific adaptations were present . The bench-press training group , utilizing heavy loads in its training , was the only group with improved one repetition maximum . Overall , findings point to the development of coordination as the determining factor in early velocity-specific strength gains 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 instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity PURPOSE To compare effects on strength in the early phase of resistance training with one or three sets and fast or slow speeds . METHODS A total of 115 healthy , untrained subjects were r and omized to a control group or one of four training groups : one set fast ( approximately 140 degrees.s(-1 ) ) , three sets fast , one set slow ( approximately 50 degrees.s(-1 ) ) , or three sets slow . All subjects attended training 3 x wk(-1 ) for 6 wk . Subjects in the training groups performed unilateral elbow flexion contractions with a target six- to eight-repetition maximum load . Control subjects sat at the training bench but did not train . One repetition maximum strength , arm circumference , and biceps skinfold thickness were measured before and after training . RESULTS One slow set increased strength by 25 % ( 95 % CI 13 - 36 % , P < 0.001 ) . Three sets of training produced greater increases in strength than one set ( difference = 23 % of initial strength , 95 % CI 12 - 34 % , P < 0.001 ) and fast training result ed in a greater increase in strength than slow training ( difference = 11 % , 95 % CI 0.2 - 23 % , P = 0.046 ) . The interaction between sets and speed was negative ( -15 % ) and of borderline significance ( P = 0.052 ) , suggesting there is a benefit of training with three sets or fast speeds , but there is not an additive benefit of training with both . CONCLUSIONS Three sets of exercise produce twice the strength increase of one set in the early phase of resistance training . Training fast produces greater strength increases than training slow ; however , there does not appear to be any additional benefit of training with both three sets and fast contractions We previously reported that low‐intensity [ 50 % of one repetition maximum ( 1RM ) ] resistance training with slow movement and tonic force generation ( LST ) causes muscle hypertrophy and strength gain in older participants . The aim of this study was to determine whether resistance training with slow movement and much more reduced intensity ( 30%1RM ) increases muscle size and strength in older adults . Eighteen participants ( 60–77 years ) were r and omly assigned to two groups . One group performed very low‐intensity ( 30 % 1RM ) knee extension exercise with continuous muscle contraction ( LST : 3‐s eccentric , 3‐s concentric , and 1‐s isometric actions with no rest between each repetition ) twice a week for 12 weeks . The other group underwent intermitted muscle contraction ( CON : 1‐s concentric and 1‐s eccentric actions with 1‐ \n Output:\n " }, { "from": "agent", "value": "Strength gains between conditions were not influenced by training status and age .\nConclusions Overall , the results suggest that fast and moderate-slow resistance training improve dynamic muscular strength similarly in individuals within a wide range of training statuses and ages .\nResistance training performed at fast movement velocities using moderate intensities showed a trend for superior muscular strength gains as compared to moderate-slow resistance training ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Complications of axillary surgery occur due to severance of the intercostobrachial nerve ( ICBN ) . The feasibility and benefit of preserving the ICBN to prevent sensory loss was studied prospect ively Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose HYPOTHESIS Axillary relapse in node-negative patients staged with sentinel lymph node ( SLN ) biopsy alone is no more frequent than in patients treated with st and ard axillary dissection . Morbidity is less for patients who had SLN biopsy . DESIGN , SETTING , AND PATIENTS Between October 14 , 1997 , and August 31 , 2001 , 1253 consecutive women with primary invasive breast cancer were prospect ively entered into an SLN biopsy data base . Completion axillary dissection was performed in 164 patients after SLN biopsy as part of a training protocol . INTERVENTIONS Patients were contacted by question naire or telephone to determine breast cancer relapse ; presence of arm lymphedema , arm pain , axillary infection , or seroma formation ; and tumor recurrence or death . MAIN OUTCOME MEASURES chi2 or Fisher exact tests and Wilcoxon rank sum tests were used to analyze categorical and continuous variables . Logistic regression was used to analyze morbidity . RESULTS Of 1253 women , 894 ( 71 % ) were node negative by SLN biopsy alone ( n = 730 [ 82 % ] ) or SLN biopsy and completion axillary dissection ( n = 164 [ 18 % ] ) . Question naires were completed by 776 patients ( 87 % ) . Mean + /- SD follow-up was 2.4 + /- 0.9 years . Patients with axillary dissections reported a significantly higher occurrence of arm lymphedema ( 34 % ) , arm pain ( 38 % ) , seroma formation ( 24 % ) , and infection ( 9 % ) vs SLN biopsy-only patients ( 6 % , 14 % , 7 % , and 3 % , respectively ) . One axillary relapse ( 0.1 % ) occurred during follow-up of 685 women who underwent SLN biopsy only . CONCLUSIONS With intermediate-term follow-up , there was 1 axillary recurrence in 685 SLN node-negative women , supporting use of SLN biopsy as an accurate method for staging breast cancer . Biopsy of the SLN was associated with significantly less morbidity than completion axillary dissection BACKGROUND Sentinel lymph node biopsy in women with operable breast cancer is routinely used in some countries for staging the axilla despite limited data from r and omized trials on morbidity and mortality outcomes . We conducted a multicenter r and omized trial to compare quality -of-life outcomes between patients with clinical ly node-negative invasive breast cancer who received sentinel lymph node biopsy and patients who received st and ard axillary treatment . METHODS The primary outcome measures were arm and shoulder morbidity and quality of life . From November 1999 to October 2003 , 1031 patients were r and omly assigned to undergo sentinel lymph node biopsy ( n = 515 ) or st and ard axillary surgery ( n = 516 ) . Patients with sentinel lymph node metastases proceeded to delayed axillary clearance or received axillary radiotherapy ( depending on the protocol at the treating institution ) . Intention-to-treat analyses of data at 1 , 3 , 6 , and 12 months after surgery are presented . All statistical tests were two-sided . RESULTS The relative risks of any lymphedema and sensory loss for the sentinel lymph node biopsy group compared with the st and ard axillary treatment group at 12 months were 0.37 ( 95 % confidence interval [ CI ] = 0.23 to 0.60 ; absolute rates : 5 % versus 13 % ) and 0.37 ( 95 % CI = 0.27 to 0.50 ; absolute rates : 11 % versus 31 % ) , respectively . Drain usage , length of hospital stay , and time to resumption of normal day-to-day activities after surgery were statistically significantly lower in the sentinel lymph node biopsy group ( all P < .001 ) , and axillary operative time was reduced ( P = .055 ) . Overall patient-recorded quality of life and arm functioning scores were statistically significantly better in the sentinel lymph node biopsy group throughout ( all P < or = .003 ) . These benefits were seen with no increase in anxiety levels in the sentinel lymph node biopsy group ( P > .05 ) . CONCLUSION Sentinel lymph node biopsy is associated with reduced arm morbidity and better quality of life than st and ard axillary treatment and should be the treatment of choice for patients who have early-stage breast cancer with clinical ly negative nodes PURPOSE To provide evidence -based recommendations to practicing oncologists , surgeons , and radiation therapy clinicians to up date the 2005 clinical practice guideline on the use of sentinel node biopsy ( SNB ) for patients with early-stage breast cancer . METHODS The American Society of Clinical Oncology convened an Up date Committee of experts in medical oncology , pathology , radiation oncology , surgical oncology , guideline implementation , and advocacy . A systematic review of the literature was conducted from February 2004 to January 2013 in Medline . Guideline recommendations were based on the review of the evidence by Up date Committee . RESULTS This guideline up date reflects changes in practice since the 2005 guideline . Nine r and omized clinical trials ( RCTs ) met systematic review criteria for clinical questions 1 and 2 ; 13 cohort studies informed clinical question 3 . RECOMMENDATIONS Women without sentinel lymph node ( SLN ) metastases should not receive axillary lymph node dissection ( ALND ) . Women with one to two metastatic SLNs planning to undergo breast-conserving surgery with whole-breast radiotherapy should not undergo ALND ( in most cases ) . Women with SLN metastases who will undergo mastectomy should be offered ALND . These three recommendation are based on RCTs . Women with operable breast cancer and multicentric tumors , with ductal carcinoma in situ ( DCIS ) who will undergo mastectomy , who previously underwent breast and /or axillary surgery , or who received preoperative/neoadjuvant systemic therapy may be offered SNB . Women who have large or locally advanced invasive breast cancer ( tumor size T3/T4 ) , inflammatory breast cancer , or DCIS ( when breast-conserving surgery is planned ) or are pregnant should not undergo SNB . These recommendations are based on cohort studies and /or informal consensus . In some cases , up date d evidence was insufficient to up date previous recommendations UNLABELLED Chronic pain following breast cancer surgery is associated with decreased health-related quality of life and is a source of additional psychosocial distress in women who are already confronting the multiple stresses of cancer . Few prospect i ve studies have identified risk factors for chronic pain following breast cancer surgery . Putative demographic , clinical , and psychosocial risk factors for chronic pain were evaluated prospect ively in 95 women scheduled for breast cancer surgery . In a multivariate analysis of the presence of chronic pain , only younger age was associated with a significantly increased risk of developing chronic pain 3 months after surgery . In an analysis of the intensity of chronic pain , however , more invasive surgery , radiation therapy after surgery , and clinical ly meaningful acute postoperative pain each independently predicted more intense chronic pain 3 months after surgery . Preoperative emotional functioning variables did not independently contribute to the prediction of either the presence or the intensity of chronic pain after breast cancer surgery . These findings not only increase underst and ing of risk factors for chronic pain following breast cancer surgery and the processes that may contribute to its development but also provide a basis for the development of preventive interventions . PERSPECTIVE Clinical variables and severe acute pain were risk factors for chronic pain following breast cancer surgery , but psychosocial distress was not , which provides a basis for hypothesizing that aggressive management of acute postoperative pain may reduce chronic pain BACKGROUND Post-mastectomy pain syndrome is defined as a chronic pain that persists beyond the normal healing time of 3 months . It is considered a neuropathic condition that arises after surgery for breast cancer . AIM To evaluate the incidence and risk factors of pain syndromes in patients undergoing surgical treatment of breast cancer in the National Cancer Institute . METHODS This study is a prospect i ve cohort of women undergoing surgical treatment for breast cancer from September 2008 to June 2009 , followed up until 6 months postoperatively . RESULTS AND CONCLUSIONS One hundred seventy-four women were examined . The mean age was 58 years . The incidence of pain syndrome was 52 % . Younger women ( < 40 years ) and those who were su bmi tted to axillary lymph node dissection ( with more than 15 lymph nodes excised ) have shown a significantly increased risk of pain syndrome after surgery for breast cancer ( relative risk ( RR ) = 5.23 95 % confidence interval ( CI ) : 1.11 - 24.64 ) and ( RR=2.01 95 % CI : 1.08 - 3.75 ) Background A sound underst and ing of the benefits of different treatment options and their health-related quality of life ( HRQoL ) impacts is required for optimal breast cancer care . Methods A cross-sectional cohort study was conducted to determine the prevalence and severity of persistent functional decrements and symptoms and identify demographic , clinical and treatment variables associated with poorer outcomes . Four hundred English-speaking women treated for ductal carcinoma-in-situ or stage I to III breast cancer between 1999 and 2009 , at least 12 months after surgery and currently disease free , were r and omly selected and invited to complete ( 1 ) the Breast Cancer Treatment Outcome Scale and ( 2 ) the EORTC core Quality of Life Question naire , version 3 . Results The response rate was 85.60 % . Many participants reported moderate to severe decrements in a number of HRQoL domains , including functional well-being ( 15 % ) , cosmetic status ( 32 % ) and overall quality of life ( 21 % ) . There were significant associations ( p < .05 ) between younger age and poorer HRQoL but none between time since surgery and morbidity ( p > .05 ) . Different treatments were associated with different HRQoL impacts . Poorer functional status was predicted by axillary dissection ( p = .011 ) , and adjuvant radiotherapy was a significant predictor of breast-specific pain ( p < .05 ) . Conclusions Many breast cancer survivors report long-term morbidity that is unaffected by time since surgery . The significant associations between the extent of locoregional therapies and poorer HRQoL outcomes emphasize the importance of the safe tailoring of these treatments PURPOSE To evaluate toxicity and cosmetic outcome ( CO ) in breast cancer survivors treated with three-dimensional conformal radiotherapy with a hypofractionated , simultaneous integrated boost ( 3D-CRT-SIB ) and to identify risk factors for toxicity , with special focus on the impact of age . METHODS AND MATERIAL S Included were 940 consecutive disease-free patients treated for breast cancer ( Stage 0-III ) with 3D-CRT-SIB , after breast-conserving surgery , from 2005 to 2010 . Physician-rated toxicity ( Common Terminology Criteria for Adverse Events version 3.0 ) and CO were prospect ively assessed during yearly follow-up , up to 5 years after radiotherapy . Multivariate logistic regression analyses using a bootstrapping method were performed . RESULTS At 3 years , toxicity scores of 436 patients were available . Grade ≥ 2 fibrosis in the boost area was observed in 8.5 % , non-boost fibrosis \n Output:\n " }, { "from": "agent", "value": "High- quality evidence showed no association with body mass index , type of breast surgery , chemotherapy or endocrine therapy .\nINTERPRETATION Development of persistent pain after breast cancer surgery was associated with younger age , radiotherapy , axillary lymph node dissection , greater acute postoperative pain and preoperative pain .\nAxillary lymph node dissection provides the only high-yield target for a modifiable risk factor to prevent the development of persistent pain after breast cancer surgery" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Studies in nonhuman primates documented that appropriate stimulation of dopamine ( DA ) D1 receptors in the dorsolateral prefrontal cortex ( DLPFC ) is critical for working memory processing . The defective ability of patients with schizophrenia at working memory tasks is a core feature of this illness . It has been postulated that this impairment relates to a deficiency in mesocortical DA function . In this study , D1 receptor availability was measured with positron emission tomography and the selective D1 receptor antagonist [11C]NNC 112 in 16 patients with schizophrenia ( seven drug-naive and nine drug-free patients ) and 16 matched healthy controls . [11C]NNC 112 binding potential ( BP ) was significantly elevated in the DLPFC of patients with schizophrenia ( 1.63 ± 0.39 ml/gm ) compared with control subjects ( 1.27 ± 0.44 ml/gm ; p = 0.02 ) . In patients with schizophrenia , increased DLPFC [11C]NNC 112 BP was a strong predictor of poor performance at the n-back task , a test of working memory . These findings confirm that alteration of DLPFC D1 receptor transmission is involved in working memory deficits presented by patients with schizophrenia . Increased D1 receptor availability observed in patients with schizophrenia might represent a compensatory ( but ineffective ) upregulation secondary to sustained deficiency in mesocortical DA function Molecular imaging has been used to estimate both drug-induced and tonic dopamine release in the striatum and most recently extrastriatal areas of healthy humans . However , to date , studies of drug-induced and tonic dopamine release have not been performed in the same subjects . This study performed positron emission tomography ( PET ) with [18F]fallypride in healthy subjects to assess ( 1 ) the reproducibility of [18F]fallypride and ( 2 ) both D-amphetamine-induced and alpha-methyl-p-tyrosine (AMPT)-induced changes in dopamin release on [(18)F]fallypride binding in striatal and extrastriatal areas . Subjects underwent [18F]fallypride PET studies at baseline and following oral D-amphetamine administration ( 0.5 mg/kg ) and oral AMPT administration ( 3 g/70 kg/day over 44 h ) . Binding potential ( BP ) ( BP(ND ) ) of [18F]fallypride was calculated in striatal and extrastriatal areas using a reference region method . Percent change in regional BP(ND ) was computed and correlated with change in cognition and mood . Test-retest variability of [18F]fallypride was low in both striatal and extrastriatal regions . D-Amphetamine significantly decreased BP(ND ) by 8 - 14 % in striatal subdivisions , cau date , putamen , substantia nigra , medial orbitofrontal cortex , and medial temporal cortex . Correlation between change in BP(ND ) and verbal fluency was seen in the thalamus and substantia nigra . In contrast , depletion of endogenous dopamine with AMPT did not effect [18F]fallypride BP(ND ) in both striatum and extrastriatal regions . These findings indicate that [18F]fallypride is useful for measuring amphetamine-induced dopamine release , but may be unreliable for estimating tonic dopamine levels , in striatum and extrastriatal regions of healthy humans [11C]PE2I is a novel positron emission tomography ( PET ) radiotracer for the dopamine transporter ( DAT ) . The reproducibility and reliability of [11C]PE2I measurements , especially in the small DAT-rich brain regions , is unknown and of critical importance to the interpretation of the data . Five healthy volunteers were scanned twice during the same day using [11C]PE2I and the HRRT PET scanner . Methods based on metabolite-corrected arterial plasma curve and reference region were used to estimate distribution volumes ( VT ) and binding potential ( BP ) . Within-subject and between-subject variabilities were compared . [11C]PE2I accumulated in the DAT-rich striatum and the midbrain . Equilibrium of specific binding appeared late in the striatum , whereas it was reached earlier in the midbrain . Plasma metabolite analysis showed that the potentially brain-penetrant 4-hydroxymethyl metabolite represented 15 % to 20 % of total plasma radioactivity . VT and BP measurements were associated with low within-subject variability . Measurement of DAT binding in small brain regions , including the substantia nigra , is reproducible and reliable using [11C]PE2I and high-resolution research tomograph . A scanning time of more than 70 mins is required for the striatum , while less is sufficient for DAT quantification in the midbrain . The previously suggested involvement of the potentially brain-penetrant radioactive metabolite in the quantification should be further studied \n Output:\n " }, { "from": "agent", "value": "Evidence for other measures /regions is limited because of the small number of studies and in some instances inconsistent findings , although significant differences were reported for D2/D3 receptors in the cingulate and uncus , for D1 receptors in the prefrontal cortex and for dopamine transporter availability in the thalamus .\nThere is a relative paucity of direct evidence for cortical dopaminergic alterations in schizophrenia , and findings are inconclusive ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Timely risk stratification is the key strategy to improve prognosis of patients with sepsis . Previous study has proposed to develop a powerful risk assessment rule by the combination of Acute Physiology and Chronic Health Evaluation II ( APACHE II ) score and plasma soluble urokinase plasminogen activator receptor ( suPAR ) . That reaffirmation of suPAR as a prognostic marker in Chinese patients with severe sepsis is the aim of the study . Methods A total of 137 consecutive Chinese patients with sepsis were enrolled in a prospect i ve study cohort . Demographic and clinical characteristics , conventional risk factors and important laboratory data were prospect ively recorded . Sequential plasma suPAR concentrations were measured by an enzymeimmunoabsorbent assay on days 1 , 3 , and 7 after admission to the intensive care unit ( ICU ) . Receiver operating characteristic ( ROC ) curves and Cox regression analysis were used to examine the performance of suPAR in developing a rule for risk stratification . Results The results showed that plasma suPAR concentrations remained relatively stable within survivors and non-survivors during the first week of disease course . Regression analysis indicated that APACHE II ≥15 and suPAR ≥10.82 ng/mL were independently associated with unfavorable outcome . With the above cutoffs of APACHE II and suPAR , strata of disease severity were determined . The mortality of each stratum differed significantly from the others . Conclusions Combination of APACHE II score and suPAR may supply the powerful prognostic utility for the mortality of sepsis In systemic inflammation and sepsis , endothelial activation and microvascular dysfunction are characteristic features that promote multiorgan failure . As symmetric dimethylarginine ( SDMA ) impacts vascular tension and integrity via modulating nitric oxide ( NO ) pathways , we investigated circulating SDMA in critical illness and sepsis . 247 critically ill patients ( 160 with sepsis , 87 without sepsis ) were studied prospect ively upon admission to the medical intensive care unit ( ICU ) and on day 7 , in comparison to 84 healthy controls . SDMA serum levels were significantly elevated in critically ill patients at admission to ICU compared to controls and remained stably elevated during the first week of ICU treatment . The highest SDMA levels were found in patients with sepsis . SDMA levels closely correlated with disease severity scores , biomarkers of inflammation , and organ failure ( renal , hepatic , and circulatory ) . We identified SDMA serum concentrations at admission as an independent prognostic biomarker in critically ill patients not only for short-term mortality at the ICU but also for unfavourable long-term survival . Thus , the significant increase of circulating SDMA in critically ill patients indicates a potential pathogenic involvement in endothelial dysfunction during sepsis and may be useful for mortality risk stratification at the ICU ABSTRACT Systemic inflammation often leads to complications in critically ill patients . Activation of the receptor for advanced glycation end-products ( RAGE ) generates inflammatory cytokines , proteases , and oxidative stress and may link inflammation to subsequent organ damage . Furthermore , hyperglycemia-induced oxidative stress increases RAGE lig and s and RAGE expression . We hypothesized that preventing hyperglycemia during critical illness reduces the risk of excessively enhanced RAGE signaling , which could relate to clinical outcomes and risk of death . In 405 long-stay surgical intensive care unit patients r and omized to intensive or conventional insulin treatment , serum concentrations of soluble RAGE ( decoy receptor ) and the RAGE lig and s high-mobility group box 1 ( HMGB1 ) and S100A12 were measured on admission , day 7 , and last day . These were compared with levels in 71 matched control subjects and with C-reactive protein ( CRP ) as a routinely monitored inflammation marker . On admission , soluble RAGE , HMGB1 , S100A12 , and CRP were higher in patients than in controls . The HMGB1 , S100A12 , and CRP remained elevated throughout intensive care unit stay , whereas soluble RAGE decreased to levels lower than in controls by day 7 . Unexpectedly , insulin treatment did not affect the circulating levels of these markers . In univariable analysis , elevated levels of soluble RAGE on admission were associated with adverse outcome , including circulatory failure , kidney failure , liver dysfunction , and mortality . The associations with circulatory and kidney failure remained significant in multivariable logistic regression analysis corrected for baseline risk factors . Critical illness affects components of RAGE signaling , unaffected by insulin treatment . Elevated on-admission soluble RAGE was associated with adverse outcomes BACKGROUND Endothelial injury is recognized to trigger organ failures during the first 48h of septic shock . We evaluate endothelial biomarkers at ICU admission in their ability to predict severity , outcome , and organ failures in septic shock patients . METHODS This prospect i ve observational pilot study was conducted in a medical intensive care unit of a university hospital . Plasma levels of endothelial biomarkers as angiopoietin-2 , sE-selectin or endocan were measured at ICU admission of 20 patients presenting with septic shock . Clinical and biological data were recorded at inclusion and each day during the first week . RESULTS Significant correlations were found between angiopoietin-2 and severity scores at Day 1 : SAPS2 ( r(2)=0.620 ; p=0.004 ) and LOD score ( r(2)=0.681 ; p=0.001 ) . The angiopoietin-2 level was significantly higher in patients presenting with organ failure such as hemodynamic , renal or hepatic failure . It correlated with catecholamine infusion dose and was higher in non survivors compared with survivors ( 33.5 [ 28.9 - 51.4 ] vs. 12.4 [6.4 - 14.7]ng/ml ; p=0.001 ) . In contrast , in that population presenting with septic shock , endocan level at inclusion was not related to any organ failure at inclusion or Day 1 but appeared lower in patients presenting with respiratory failure at Day 3 compared to those who do not ( 1.9 [ 0.99 - 3.1 ] vs 5.2 [3.1 - 17.2]ng/ml ; p=0.032 ) . The endocan level at inclusion was correlated with the decrease in PaO2/FiO2 ratio at Day 2 ( r(2)=0.628 ; p=0.0004 ) and Day 3 ( r(2)=0.645 ; p=0.005 ) . Endocan level < 2.54ng/ml at admission is predictive of a respiratory failure presence at Day 3 . CONCLUSION In septic shock patients , angiopoietine-2 is related with clinical severity during the first 24h but only endocan is able to predict the presence of respiratory failure at Day 3 Introduction The endothelial specific angiopoietin (Ang)-Tie2 lig and -receptor system has been identified as a non-redundant mediator of endothelial activation in experimental sepsis . Binding of circulating Ang-1 to the Tie2 receptor protects the vasculature from inflammation and leakage , whereas binding of Ang-2 antagonises Tie2 signalling and disrupts endothelial barrier function . Here , we examine whether circulating Ang-1 and /or Ang-2 independently predict mortality in a cohort of critically ill medical patients . Methods Circulating vascular endothelial growth factor ( VEGF ) , Ang-1 and Ang-2 were prospect ively measured in sera from 29 healthy controls and 43 medical ICU patients by immunoradiometric assay ( IRMA ) and ELISA , respectively . Survival after 30 days was the primary outcome studied . Results Median serum Ang-2 concentrations were increasingly higher across the following groups : healthy controls , patients without sepsis , patients with sepsis and patients with septic shock . In contrast , Ang-1 and VEGF concentrations were significantly lower in all patient groups compared with healthy controls . Ang-2 correlated with partial pressure of oxygen in arterial blood (PaO2)/fraction of inspired oxygen ( FiO2 ) , tissue hypoxia , Sequential Organ Failure Assessment ( SOFA ) and Physiology and Chronic Health Evaluation II ( APACHE II ) score . Multivariate Cox regression analyses confirmed a strong independent prognostic impact of high Ang-2 as a novel marker of 30-day survival . Conclusions A marked imbalance of the Ang-Tie system in favour of Ang-2 is present in critically ill medical patients . Our findings highlight the independent prognostic impact of circulating Ang-2 in critical illness . Ang-2 may be used as a readily available powerful predictor of outcome and may open new perspectives to individualise treatment in the ICU Introduction High-mobility group box-1 protein ( HMGB1 ) has been known as a chromosomal protein for many years . HMGB1 has recently been shown to be a proinflammatory cytokine with a role in the immunopathogenesis of sepsis . Lipopolysaccharide-binding protein ( LBP ) has a central role in the innate immune response when the host is challenged by bacterial pathogens . Procalcitonin ( PCT ) has been suggested as a marker of severe bacterial infections and sepsis . The aim of the present study was to investigate levels of HMGB1 , LBP and PCT in a well-characterised sepsis cohort . The study plan included analysis of the levels of the inflammatory markers in relation to the severity of infection , to the prognosis and to the ability to identify patients with bacteraemia . Methods Patients suspected of having severe infections and admitted to a department of internal medicine were included in a prospect i ve manner . Demographic data , comorbidity , routine biochemistry , microbiological data , infection focus , severity score and mortality on day 28 were recorded . Plasma and serum were sample d within 24 hours after admission . Levels of all studied markers ( HMGB1 , LBP , PCT , IL-6 , C-reactive protein , white blood cell count and neutrophils ) were measured with commercially available laboratory techniques . Results A total of 185 adult patients were included in the study ; 154 patients fulfilled our definition of infection . Levels of HMGB1 , LBP and PCT were higher in infected patients compared with a healthy control group ( P < 0.0001 ) . Levels of HMGB1 , LBP and PCT were higher in the severe sepsis group compared with the sepsis group ( P < 0.01 ) . No differences were observed in levels of the inflammatory markers in fatal cases compared with survivors . Levels of all studied markers were higher in bacteraemic patients compared with nonbacteraemic patients ( P < 0.05 ) . PCT performed best in a receiver – operator curve analysis discriminating between bacteraemic and nonbacteraemic patients ( P < 0.05 ) . HMGB1 correlated to LBP , IL-6 , C-reactive protein , white blood cell count and neutrophils ( P < 0.001 ) . LBP correlated to PCT , IL-6 and C-reactive protein ( P < 0.001 ) . Conclusion Levels of HMGB1 , PCT and LBP were higher in infected patients compared with those in healthy controls , and levels were higher in severe sepsis patients compared with those in sepsis patients . Levels of all studied inflammatory markers ( HMGB1 , LBP , PCT , IL-6 ) and infection markers ( C-reactive protein , white blood cell count , neutrophils ) were elevated among bacteraemic patients . PCT performed best as a diagnostic test marker for bacteraemia Purpose Sepsis is a major health burden worldwide . Pre clinical investigations in animals and retrospective studies in patients have suggested that inhibition of platelets may improve the outcome of sepsis . In this study we investigated whether chronic antiplatelet therapy impacts on the presentation and outcome of sepsis , and the host response . Methods We performed a prospect i ve observational study in 972 patients admitted with sepsis to the mixed intensive care units ( ICUs ) of two hospitals in the Netherl and s between January 2011 and July 2013 . Of them , 267 patients ( 27.5 % ) were on antiplatelet therapy ( 95.9 % acetylsalicylic acid ) before admission . To account for differential likelihoods of receiving antiplatelet therapy , a propensity score was constructed , including variables associated with use of antiplatelet therapy . Cox proportional hazards regression was used to estimate the association of antiplatelet therapy with mortality . Results Antiplatelet therapy was not associated with sepsis severity at presentation , the primary source of infection , causative pathogens , the development of organ failure or shock during ICU stay , or mortality up to 90 days after admission , in either unmatched or propensity-matched analyses . Antiplatelet therapy did not modify the values of 19 biomarkers providing insight into hallmark host responses to sepsis , including activation of the coagulation system , the vascular endothelium , the cytokine network , and renal function , during the first 4 days after ICU admission . Conclusions Pre-existing antiplatelet therapy is not associated with alterations in the presentation or outcome of sepsis , or the host response Purpose : Sclerostin is a negative regulator of bone metabolism and associated with chronic morbidities . We investigated circulating sclerostin in critically ill patients . Methods : A total of 264 patients ( 170 with sepsis ) were studied prospect ively upon admission to the medical intensive care unit ( ICU ) and on day 7 . Patients ' survival was followed for up to \n Output:\n " }, { "from": "agent", "value": "Conclusions Ang-1 , Ang-2 , and suPAR provide beneficial prognostic information about mortality in adult patients with sepsis ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Hydration with topical emollients forms the backbone of treatment for mild atopic dermatitis ( AD ) , but few r and omized controlled trials have assessed their efficacy in young children . OBJECTIVES Assess the efficacy and tolerability of long-term emollient therapy in the treatment of moderate to severe xerosis in young children with AD . METHODS This was a phase III , multicentre , double-blind , r and omized , vehicle-controlled trial . Children ( n = 251 ) aged 2 - 6 years with AD-associated xerosis were r and omized 1 : 1 to a 28-day treatment with an emollient combining glycerol and paraffin or its vehicle . Non-responders at the end of the double-blind period were treated open label with emollient until day 84 . Responders stopped treatment until re assessment on day 56 . Those who relapsed after stopping treatment were treated open label with emollient until day 84 . RESULTS During the double-blind period , xerosis score ( XS ) of the scoring atopic dermatitis ( SCORAD ) index , objective SCORAD and visual analogue score decreased and skin hydration increased more in the emollient group than in the vehicle group ( P < 0.001 for all measures ) . More patients were responders with emollient than with vehicle ( 66.1 % vs. 45.6 % , P < 0.001 ) . During the open-label period , stopping emollient treatment led to relapse but improvement returned if treatment was restarted with emollient . Regular use of the emollient also yielded improvement in children who did not initially respond . Adverse events were similar in the two groups , and no treatment-related severe adverse events were reported . CONCLUSIONS Long-term therapy with emollient is effective and well tolerated for the treatment of xerosis in children with atopic dermatitis Background : Atopic dermatitis ( AD ) is characterized by barrier abnormalities , including insufficient ceramides in the stratum corneum ( SC ) . Objective : To measure the effects of a new moisturizer ( CRM ) containing a ceramide precursor in improving skin barrier function in patients with controlled atopic dermatitis . Methods : In this r and omized , intra-individual comparison , investigator-blinded study , CRM was applied to the test area of one lower leg for 27 days ( the other leg remained as untreated control ) . Evaluations at baseline and day 28 included transepidermal water loss ( TEWL ) , skin hydration by corneometry , dryness severity , Raman spectroscopy , and collection of adverse events . Results : After 4 weeks of treatment , results showed a significantly greater reduction of TEWL and clinical dryness scores , and increased skin hydration ( all p < 01 ) in the CRM-treated than untreated area . A significantly higher level of ceramide ( p < 05 ) and a trend toward increased water content was observed with Raman in the SC for CRM than for the control . There were no related AEs . Conclusion : Skin barrier function and hydration were significantly improved after CRM treatment New treatment modalities are needed in atopic dermatitis . We evaluated the pharmacokinetics , safety , tolerability , and efficacy of topical cis-urocanic acid ( cis-UCA ) cream in r and omised vehicle-controlled double-blinded clinical trials . The subjects received 5 % cis-UCA emulsion cream and control vehicle on volar forearms after right-left r and omisation . Study 1 : 16 healthy subjects received one dose on the skin and , a week later , on DMSO-irritated skin . Study 2 : 16 healthy subjects received 2 daily doses for 10 days . Study 3 : 13 patients with mild to moderate disease were treated on selected skin lesions twice daily for 28 days . Study treatments were well tolerated . cis-UCA remained close to endogenous levels in plasma and urine . cis-UCA reduced transepidermal water loss ( TEWL ) both in healthy subjects and in the patients . Eczema area severity index and physician 's global assessment improved from baseline with both treatments . cis-UCA cream improved skin barrier function and suppressed inflammation in the human skin Patients with atopic dermatitis ( AD ) have an epidermal barrier dysfunction , which allows invasion of allergens to occur . Stratum corneum skin barrier is formed by corneocytes and extracellular lipids extruded from the epidermal lamellar bodies . In a controlled , r and omized , double-blinded , right-left comparison study we investigated the effect of pimecrolimus ( PIM ) cream compared with triamcinolone acetonide cream ( TA ) on the skin barrier in 15 patients with symmetrical elbow lesions of AD . In punch biopsies , before and after treatment , skin lipid bilayer and lamellar body structure were examined by transmission electron microscopy ( TEM ) . Partial Eczema Area and Severity Index ( pEASi ) , stratum corneum hydration , and transepidermal water loss ( TEWL ) were monitored on days 1 , 8 and 22 . The pEASi was significantly more improved with TA compared with PIM , whereas stratum corneum hydration was slightly more improved after treatment with PIM . The TEM revealed a strong reduction in lamellar bodies in lesional skin of AD ; only 32 % of the lamellar bodies were normal . A significantly higher number of normal lamellar bodies was found after 3 weeks of treatment with PIM ( 58 % ; p < 0.005 ) . An increase in lamellar bodies also occurred with TA treatment ( 46 % ; p < 0.05 ) ; however , significantly less than with PIM ( p < 0.05 ) . Clinical score and TEWL were more improved after treatment with TA , whereas the lamellar bodies were more normal after treatment with PIM Background : Pruritus ani ( PA ) is defined as intense chronic itching affecting perianal skin . Objective : We aim ed to determine the efficacy of topical tacrolimus treatment in atopic dermatitis ( AD ) patients who have PA . Methods : The study included 32 patients with AD who were suffering PA . Patients were r and omized into two groups . In total , 16 patients used 0.03 % tacrolimus ointment and 16 patients used vaseline as placebo . All groups applied topical treatments to their perianal area twice daily for 4 weeks . The treatments were then reversed for 4 weeks after a 2 weeks wash out period . Results : In total , 32 patients with AD who had refractory anal itching were enrolled in this study . None of the patients had obtained successful results with previous treatments . There was a statistically significant decrease in the recorded EASI , DLQI and itching scores for the tacrolimus group compared to the placebo group at weeks 4 and 6 of treatment ( p < 0.05 ) . Conclusion : Topical tacrolimus treatment was well tolerated and effective in controlling persistent PA in AD patients Background : No study has clearly demonstrated the steroid-sparing effect of emollients in the treatment of atopic dermatitis ( AD ) . Aim : Evaluating the effect of an emollient containing oat extracts on the amount of topical corticosteroids used in infants with moderate to severe AD . Study Design : During 6 weeks , 173 infants under 12 months old treated for inflammatory lesions by moderate- and /or high-potency topical corticosteroids r and omly received the emollient or not ( control group ) . Methods : Evaluation of corticosteroid consumption by weighing the tubes , disease severity by the Scoring Atopic Dermatitis Index ( SCORAD ) , and infants ’ and parents ’ quality of life by Infant ’s Dermatitis Quality of Life Index and Dermatitis Family Impact scores at D0 , D21 and D42 . Results : Compared to the control group , the amount of moderate- and high-potency corticosteroids used in 6 weeks decreased by 7.5 % ( not significant ) and 42 % ( p < 0.05 ) , respectively , in the emollient group . The SCORAD index , and infants ’ and parents ’ quality of life significantly improved ( p < 0.0001 ) in both groups . Conclusion : The emollient treatment significantly reduced the high-potency topical corticosteroid consumption in infants with AD Parental education is important in managing childhood atopic dermatitis ( AD ) . We evaluated the long-term effects of a 2-day parental education program ( PEP ) on childhood AD . In an investigator-blinded , r and omized controlled trial , 59 children age 6 months to 6 years with moderate to severe AD and their mothers were recruited in Japan . Participants were given a booklet about AD and received conventional treatment alone or in combination with a 2-day PEP comprising three lectures , three practical sessions , and a group discussion . The primary outcome was evaluation of eczema severity using SCORing Atopic Dermatitis ( SCORAD ) at 6 months . Secondary outcomes included changes in symptom scores , amount of corticosteroid used , parental quality of life as determined according to the Dermatitis Family Impact question naire , and change in parental anxiety regarding the use of corticosteroids in their children . Participants in the PEP group had a significantly lower SCORAD score than those in the control group at 6 months ( mean difference 10.0 , 95 % confidence interval [ CI ] = 2.3 - 17.7 , p = 0.01 ) and objective SCORAD score ( mean difference 7.1 , 95 % CI = 0.8 - 13.5 , p = 0.03 ) . The sleeplessness symptom score ( mean difference 1.6 , 95 % CI = 0.0 - 3.1 , p = 0.048 ) and corticosteroid anxiety score ( p = 0.02 ) in the PEP group were significantly better than in the control group at 6 months . There was no significant difference between groups in the amount of corticosteroid used or quality of life . The PEP had positive long-term effects on eczema severity and parental anxiety about corticosteroid usage Abstract Background : Atopic dermatitis ( AD ) is a disease with multifactorial etiology . Staphylococcus aureus is one of the predominant environmental factors acting on the course and intensity of the disease . Objectives : The aims of the study were to evaluate the efficacy and safety of clothing made of cellulose fibers with seaweed enriched with silver ions in the treatment of children with AD . Methods : A prospect i ve , r and omized and double-blinded controlled selection was done to recruit 19 children with diagnosis of AD . This sample was divided in two groups with similar demographic and clinical characteristics ( the “ control ” group of seven children who wore placebo clothing and the “ trial textile ” group of 12 children who wore clothing with the new textile ) . The severity of AD and clinical response were assessed by the SCORAD index , the intensity of pruritus and the changes in sleep characteristics , at the start of the study and after 7 and 90 d. Results : The SCORAD index improvement in the group with the fiber under study was statistically significant after the first 7 d of treatment ( p < 0.001 ) and was reduced by about 45 % after 90 d. There was also a statistically relevant reduction of the intensity of pruritus and an improvement in the sleep quality after the initial 7 d and at day 90 . Conclusion : The results showed that the textile clothing with seaweed enriched with silver ions brings a quicker improvement of the patients in the first days in opposition to the use of st and ard all-cotton clothes . The results also reinforce the importance of non-pharmacological measures , like clothing , in the management of patients with a diagnosis of AD Introduction : The natural cyclic tetrahydropyrimidine , ectoine , is a low-molecular , water-binding , organic osmolyte . Previously , topical application of ectoine to healthy human skin was shown to improve skin hydration as well as skin barrier function . Objectives : We therefore speculated that topical application of ectoine would be beneficial for patients with atopic dermatitis ( AD ) , in which a genetically defined defect in skin barrier function is of major pathogenetic relevance . We assessed the efficacy of an ectoine-containing cream ( EHK02 - 01 ) in the management of 65 patients with mild to moderate AD in a r and omized , intra-individual , double-blind , multi-center trial , in which the efficacy of ectoine was compared to a nonsteroidal anti-inflammatory cream previously found to primarily act on skin barrier function and therefore with a comparable mode of action . Methods : Sixty-five patients with mild to moderate AD aged 18 - 65 years were enrolled . The patients applied EHK02 - 01 and the control cream on two symmetrical lesions twice daily for 28 days . At the beginning , after 7 and after 28 days , treated skin areas were assessed by modified , objective local SCORAD ( Scoring Atopic Dermatitis ) and IGA ( Investigator 's Global Assessment ) as well as the patients ' judgment of efficacy and their assessment of pruritus . Results : EHK02 - 01 was found to be very well tolerated . Even more important , efficacy of EHK02 - 01 treatment was equivalent to that achieved with the reference product . Conclusion : These results indicate that topical treatment with EHK02 - 01 may represent a novel option for the treatment of patients with AD Natural oils are advocated and used throughout the world as part of neonatal skin care , but there is an absence of evidence to support this practice . The goal of the current study was to ascertain the effect of olive oil and sunflower seed oil on the biophys \n Output:\n " }, { "from": "agent", "value": "Studies on the topical treatment of atopic dermatitis largely supported the recommended use of topical corticosteroids and topical calcineurin inhibitors .\nLipoxin A4 , an eicosanoid with anti-inflammatory properties , and a 5 % cis-urocanic acid emulsion cream were effective in the treatment of atopic dermatitis , although studies were small .\nAdjunct therapy with bleach baths , natural oils , and textiles all showed some benefit ; however , studies are limited .\nSUMMARY There is strong evidence for the use of topical anti-inflammatory therapies in the treatment of atopic dermatitis .\nThere is little evidence to suggest that one emollient is better than others" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n 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 ( 4 occlusal sealant applications ) groups with peak levels of 3.98 ng/ml and 9.08 ng/ml , respectively . The blood serum did not contain BPA at any point in this investigation . CONCLUSIONS Exposure to BPA from sources other than dental resins contributes to salivary baseline concentration levels and indicates environmental exposure and use of products containing BPA . Use of specific molecular formulations of dental sealant material determines the release of BPA , therefore , dental sealant material s should be review ed independently when question ing the release of BPA from dental sealants . In addition , dosage amounts of the dental sealant material used in this study do not influence the serum concentration levels of BPA . Further research is needed to examine the cumulative estrogenic effects of BPA from dental sealants The hypotheses tested were : survival rate of fully and partially retained glass-carbomer sealants is higher than those of high-viscosity glass-ionomer , with and without energy supplied , and that of resin composite ; survival rate of fully and partially retained sealants of high-viscosity glass-ionomer with energy supplied is higher than those without energy supplied . The r and omized clinical trial covered 407 children , with a mean age of 8 years . The evaluation took place after 0.5 , 1 and 2 years . Survival of sealant material in occlusal and in smooth surfaces , using the traditional categorization ( fully and partially retained versus completely lost sealants ) and the modified categorization ( fully and more than 2/3 of the sealant retained versus completely lost sealants ) , were dependent variables . The Kaplan – Meier survival method was used . According to both categorizations of partially retained sealants , the survival of completely and partially retained resin composite sealants in occlusal and in smooth tooth surfaces was statistically significantly higher , and those of glass-carbomer sealants lower , than those of sealants of the other three groups . There was no statistically significant difference in the survival rates of completely and partially retained high-viscosity glass-ionomer sealants with and without energy supplied in occlusal and in smooth surfaces . After 2 years , glass-carbomer sealant retention was the poorest , adding energy to high-viscosity glass-ionomer sealant did not increase the retention rate and resin composite sealants were retained the longest . We suggest the use of the modified categorization of partially retained sealants in future studies . It seems not necessary to cure high-viscosity glass-ionomer sealants . The use of glass-carbomer sealants can not be recommended yet To investigate the effectiveness of topical fluorides in preventing fissure caries , we conducted a r and omized controlled trial with parallel groups . In total , 501 children ( 1,539 molars , 3,078 sites ) , mean age 9.1 years , who had at least one sound permanent first molar with deep fissures or fissures with signs of early caries were recruited . They were r and omly allocated among four groups : ( 1 ) resin sealant , single placement ; ( 2 ) 5 % NaF varnish , semi-annual application ; ( 3 ) 38 % silver diamine fluoride ( SDF ) solution , annual application ; and ( 4 ) placebo control . Follow-up examinations were conducted every 6 months by a masked examiner . After 24 months , 485 children ( 97 % ) were examined . Proportions of pit/fissure sites with dentin caries in the sealant , NaF , SDF , and control groups were 1.6 % , 2.4 % , 2.2 % , and 4.6 % , respectively . A multi-level logistic regression analysis accounting for the effects of data clustering and confounding factors showed that fissures in any of the three treatment groups had significantly lower risks of carious cavity development into dentin than did controls ( p < 0.05 ) . We concluded that placement of resin sealant , semi-annual application of NaF varnish , and annual application of SDF solution are all effective in preventing pit and fissure caries in permanent molars ( Clinical Trials.gov number CT01446107 ) UNLABELLED The objective of the present study provides further data comparing retention , marginal integrity and caries preventive effects of two fissure sealants ( glass ionomer based ; GC Fuji VII Capsule [ Fuji VII ] and ormocer based ; Admira Seal [ AS ] ) in children . This study was design ed as a r and omized single-blind clinical trial . The permanent first molars ( PFMs ) of 50 children , 7 - 13 years of age ( mean age : 8.9 + /- 1.3 years ) , were sealed with a split-mouth design . Fissure sealants applied to the PFMs according to the manufacturer 's recommendations by one pediatric dentist . Clinical evaluation of the sealants was carried out to record retention , marginal integrity and presence of caries at 6 , 12 , 18 and 24 months after placement by the other pediatric dentist . Kaplan-Meier survival analysis and Cox 's regression models were used to estimate the probability of two sealants success . RESULTS Alpha and Bravo retention rates at the end of follow-up were 13 % and 80 % for Fuji VII and 3 % and 83 % for AS , respectively . For retention and marginal integrity between fissure sealants was found similar survival rates ( p > 0.05 ) . After 24 months , presence of caries was 16 % for Fuji VII and 32 % for AS ( p < 0.05 ) . CONCLUSION Fuji VII and AS exhibited similar retention and marginal integrity during 24 months . However Fuji VII was showed better results than AS for caries preventive effect . Consequently , Fuji VII sealants may be a better choice for preventing occlusal caries PURPOSE The aim of this work is to study and compare the retention rate , caries-preventing and antibacterial effects of resin-modified glass ionomer and flowable composite in comparison to conventional fissure sealant . METHODS Forty-five children aged 7 - 10 years with newly erupted lower first permanent molars were r and omly divided into three equal treatment groups . Group I : sealed by a conventional resin sealant ; Group II : sealed by resin modified glass ionomer ( RMGI ) ; and Group III : sealed by flowable composite . Retention and caries status of the sealed teeth were recorded after 1 month , 6 months , year and 2 years . In addition , Streptococcus mutans counts were assessed at baseline , 1 day , 1 month , 6 months , 1 year and 2 years after sealant application . Data were analyzed by Fisher exact , chi-square and ANOVA tests . RESULTS Group III and Group I showed significantly higher retention rates than Group II fissure sealant ( p<0.05 ) . There were no differences of the caries-preventive effects between the tested sealant material s throughout the duration of the study . Streptococcus mutans counts were significantly lower in group II compared to group I or group III up to 6 months of the study ( p<0.05 ) . After 1 year of the study the differences of Streptococcus mutans counts were not significant ( p>0.05 ) . CONCLUSION This study indicated a lower retention of RMGI compared to flowable composite and resin sealant without significant difference in caries prevention or long-term bacterial inhibition BACKGROUND The authors conducted a study to survey the perspectives of dentists regarding the 2010 American Dental Association ( ADA ) recommendation to seal non-cavitated carious lesions ( NCCLs ) in children and young adults . METHODS The authors mailed a question naire to a r and omly selected sample of 2,400 general dentists ( GDs ) and pediatric dentists ( PDs ) in the United States . The sample was chosen by the ADA 's Survey Center . The question naire included two photographs of NCCLs ( permanent first molar and premolar ) in a 12-year-old child . Respondents were provided with \n Output:\n " }, { "from": "agent", "value": "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 .\nFinally , 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 ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: This study explored the equivalence of physical function assessment by physical therapists ( PTs ) during face-to-face and remote administration of the European Stroke Scale ( ESS ) and the Functional Reach Test ( FRT ) to 26 subjects with a history of stroke . Patients were r and omized to remote or face-to-face administration groups . Each patient was simultaneously rated by both the face-to-face and remote PTs . The PTs were blinded to each other 's results . Equivalence was set at the 95 % limits of agreement . When the face-to-face PT directed the patient , the two PTs reported equivalent values in more than 90 % of the patients for the FRT and for all ESS components , with the exception of gait ( 83 % ) and maintaining leg position ( 85 % ) . When the remote PT directed the patient , the two PTs reported equivalent values in more than 90 % of the patients for the FRT and more than 83 % for all ESS components . Televideo assessment of function by PTs is substantially equivalent to a face-to-face encounter BACKGROUND AND PURPOSE Telemedicine can disseminate vascular neurology expertise and optimize recombinant tissue plasminogen activator ( rt-PA ) use for acute ischemic stroke in rural underserved communities . The purpose of this study was to prospect ively assess whether telemedicine or telephone was superior for decision-making . METHODS The study design is a pooled analysis of two identically design ed r and omized controlled trials conducted in a multistate hub and spoke telestroke network setting with acute stroke syndrome patients , comparing telemedicine versus telephone-only consultations . From each trial , common data elements were pooled to assess , principally , for correctness of thrombolysis decision-making . Secondary outcomes included rt-PA use rate , 90-day functional outcome , post-thrombolysis intracranial hemorrhage , and data completeness . RESULTS Two hundred seventy-six pooled patients were evaluated . Correct thrombolysis eligibility decisions were made more often with telemedicine ( 96 % telemedicine , 83 % telephone ; odds ratio [ OR ] 4.2 ; 95 % confidence interval [ CI ] 1.69 - 10.46 ; p=0.002 ) . Intravenous rt-PA usage was 26 % ( 29 % telemedicine , 24 % telephone ; OR 1.27 ; 95 % CI 0.71 - 2.25 ; p=0.41 ) . Ninety-day outcomes were not different for Barthel Index , modified Rankin Scale , or mortality . There was no difference in post-thrombolysis intracranial hemorrhage ( 8 % telemedicine , 6 % telephone ; p>0.999 ) . CONCLUSIONS This pooled analysis supports the hypothesis that stroke telemedicine consultations , compared with telephone-only , result in more accurate decision-making . Together with high rt-PA utilization rate , low post-rt-PA intracranial hemorrhage rate , and acceptable patient outcome , the results confirm that telemedicine is a viable consultative tool for acute stroke . The replication of the hub and spoke network infrastructure supports the generalizability of telemedicine when used in broader setting We conducted a pilot telerehabilitation study with post-stroke patients with arm motor impairment . We compared the degree of satisfaction of patients undergoing a virtual reality ( VR ) therapy programme at home ( Tele-VR group ) to satisfaction experienced by those undergoing the same VR therapy in a hospital setting ( VR-group ) . The rehabilitation equipment used a 3D motion tracking system to create a virtual environment in which the patient 's movement was represented . In tele-therapy , the patient equipment was installed in their homes , connected to the hospital by four ISDN lines at a total b and width of 512 kbit/s . Rehabilitation data were transmitted via one line and videoconferencing via the other three . Ten patients with mild to intermediate arm motor impairment due to an ischaemic stroke , were r and omized into VR or Tele-VR groups . A question naire was used at the end of treatment to measure each patient 's degree of satisfaction . Tele-VR treated patients showed median values equal to or higher than the VR group patients in all 12 items investigated , except one . In motor performance , the Tele-VR group improved significantly ( P ≤ 0.05 ) , while the VR group showed no significant change . Patients assigned to the Tele-VR group were able to engage in therapy at home and the videoconferencing system ensured a good relationship between the patient and the physical therapist whose physical proximity was not required Background and Purpose — Telemedicine techniques can be used to address the rural – metropolitan disparity in acute stroke care . The Stroke Team Remote Evaluation Using a Digital Observation Camera ( STRokE DOC ) trial reported more accurate decision making for telemedicine consultations compared with telephone-only and that the California-based research network facilitated a high rate of thrombolysis use , improved data collection , low risk of complications , low technical complications , and favorable assessment times . The main objective of the STRokE DOC Arizona TIME ( The Initial Mayo Clinic Experience ) trial was to determine the feasibility of establishing , de novo , a single-hub , multirural spoke hospital telestroke research network across a large geographical area in Arizona by replicating the STRokE DOC protocol . Methods — Methods included prospect i ve , single-hub , 2-spoke , r and omized , blinded , controlled trial of a 2-way , site-independent , audiovisual telemedicine system design ed for remote examination of adult patients with acute stroke versus telephone consultation to assess eligibility for treatment with intravenous thrombolysis . The primary outcome measure was whether the decision to give thrombolysis was correct . Secondary outcomes were rate of thrombolytic use , 90-day functional outcomes , incidence of intracerebral hemorrhages , and technical observations . Results — From December 2007 to October 2008 , 54 patients were assessed , 27 of whom were r and omized to each arm . Mean National Institutes of Health Stroke Scale score at presentation was 7.3 ( SD 6.2 ) points . No consultations were aborted ; however , technical problems ( 74 % ) were prevalent in the telemedicine arm . Overall , the correct treatment decision was established in 87 % of the consultations . Both modalities , telephone ( 89 % correct ) and telemedicine ( 85 % correct ) , performed well . Intravenous thrombolytic treatment was used in 30 % of the telemedicine and telephone consultations . Good functional outcomes at 90 days were not significantly different . There were no statistically significant differences in mortality ( 4 % in telemedicine and 11 % in telephone ) or rates of intracerebral hemorrhage ( 4 % in telemedicine and 0 % in telephone ) . Conclusions — It is feasible to extend the original STRokE DOC trial protocol to a new state and establish an operational single-hub , multispoke rural hospital telestroke research network in Arizona . The trial was not design ed to have sufficient power to detect a difference between the 2 consultative modes : telemedicine and telephone-only . Whether by telemedicine or telephone consultative modalities , there were appropriate treatment decisions , high rates of thrombolysis use , improved data collection , low rates of intracerebral hemorrhage , and equally favorable time requirements . The learning curve was steep for the hub and spoke personnel of the new telestroke network , as reflected by frequent technical problems . Overall , the results support the effectiveness of highly organized and structured stroke telemedicine networks for extending expert stroke care into rural remote communities lacking sufficient neurological expertise Background and Purpose — Despite Food and Drug Administration approval of tissue-type plasminogen activator for stroke , obstacles in the US healthcare system prevent its widespread use . The Remote Evaluation for Acute Ischemic Stroke ( REACH ) program was developed to address these issues in rural setting s. A key component of stroke assessment in the REACH system is the National Institutes of Health Stroke Scale ( NIHSS ) evaluation . We sought to determine whether , using the REACH system , NIHSS values of bedside and remote evaluators would correspond . Methods — Twenty patients were recruited . On obtaining consent , a neurologist performed a bedside NIHSS evaluation on each patient . Within 1 hour , using any broadb and -connected workstation — either office or home personal computer and a l and line phone to speak with the patient — a second neurologist remotely evaluated the patient through the REACH system . Paired t tests and Pearson correlation coefficients were used to examine NIHSS reliability performed bedside and remotely . Results — NIHSS ranged from 1 to 24 . Correlations between bedside and remote locations ( r = 0.9552 , P = 0.0001 ) were very strong , and t tests indicate that the means were not different . Conclusions — The NIHSS can be reliably performed over the REACH system . This supports our endeavor to bring stroke expertise to rural community hospitals We conducted a r and omized controlled multicentre trial to investigate the feasibility of a telerehabilitation intervention for arm/h and function ( the Home Care Activity Desk [ HCAD ] training ) in a home setting . Usual care was compared to HCAD training . The hypothesis was that the clinical outcomes of the HCAD intervention would be at least the same as those measured after a period of usual care for patients with stroke , traumatic brain injury ( TBI ) and multiple sclerosis ( MS ) with respect to their arm/h and function . Eighty-one patients with affected arm/h and function result ing from either stroke , MS or TBI were recruited in Italy , Spain and Belgium ; 11 were lost during follow-up ( 14 % ) . The outcome measures were the Action Research Arm Test ( ARAT ) and the Nine Hole Peg Test ( NHPT ) . There were no significant differences between the two groups on the outcome measures ( ARAT and NHPT ) ; in both groups , patients maintained or even improved their arm/h and function . The HCAD training was found to be as feasible as usual care in terms of clinical outcomes , and both therapists and patients were satisfied with the HCAD intervention . A telerehabilitation intervention using HCAD may increase the efficiency of care BACKGROUND To increase the effective use of thrombolytics for acute stroke , the expertise of vascular neurologists must be disseminated more widely . We prospect ively assessed whether telemedicine ( real-time , two-way audio and video , and digital imaging and communications in medicine [ DICOM ] interpretation ) or telephone was superior for decision making in acute telemedicine consultations . METHODS From January , 2004 , to August , 2007 , patients older than 18 years who presented with acute stroke symptoms at one of four remote spoke sites were r and omly assigned , through a web-based , permuted blocks system , to telemedicine or telephone consultation to assess their suitability for treatment with thrombolytics , on the basis of st and ard criteria . The primary outcome measure was whether the decision to give thrombolytic treatment was correct , as determined by central adjudication . Secondary outcomes were the rate of thrombolytic use , 90-day functional outcomes ( Barthel index [ BI ] and modified Rankin scale [ mRS ] ) , the incidence of intracerebral haemorrhages , and technical observations . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00283868 . FINDINGS 234 patients were assessed prospect ively . 111 patients were r and omised to telemedicine , and 111 patients were r and omised to telephone consultation ; 207 completed the study . Mean National Institutes of Health stroke scale score at presentation was 9.5 ( SD 8.1 ) points ( 11.4 [ 8.7 ] points in the telemedicine group versus 7.7 [ 7.0 ] points in the telephone group ; p=0.002 ) . One telemedicine consultation was aborted for technical reasons , although it was included in the analyses . Correct treatment decisions were made more often in the telemedicine group than in the telephone group ( 108 [ 98 % ] vs 91 [ 82 % ] , odds ratio [ OR ] 10.9 , 95 % CI 2.7 - 44.6 ; p=0.0009 ) . Intravenous thrombolytics were used at an overall rate of 25 % ( 31 [ 28 % ] telemedicine vs 25 [ 23 % ] telephone , 1.3 , 0.7 - 2.5 ; p=0.43 ) . 90-day functional outcomes were not different for BI ( 95 - 100 ) ( 0.6 , 0.4 - 1.1 ; p=0.13 ) or for mRS score ( 0.6 , 0.3 - 1.1 ; p=0.09 ) . There was no difference in mortality ( 1.6 , 0.8 - 3.4 ; p=0.27 ) or rates of intracerebral haemorrhage after treatment with thrombolytics ( 2 [ 7 % ] telemedicine vs 2 [ 8 % ] telephone , 0.8 , 0.1 - 6.3 ; p=1.0 ) . However , there were more incomplete data in the telephone group than in the telemedicine group ( 12%vs 3 % , 0.2 , 0.1 - 0.3 ; p=0.0001 ) . INTERPRETATION The authors of this trial report that stroke telemedicine consultations result in more accurate decision making compared with telephone consultations and can serve as a model for the effectiveness of telemedicine in other medical specialties . The more appropriate decisions , high rates of thrombolysis use , improved data collection , low rate of intracerebr \n Output:\n " }, { "from": "agent", "value": "The use of telemedicine for post-stroke care is nascent and is primarily focused on post-stroke rehabilitation" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: GOAL We evaluated the effect of venesections and restricted diet on iron and metabolic indices and liver function tests in patients with insulin-resistance hepatic iron overload ( IR-HIO ) . MATERIAL S AND METHODS Patients were divided in three groups : ( a ) patients without any therapy who were followed-up for 36 + 28 months ; ( b ) patients venesected ; and ( c ) patients on dietary treatment . In each group baseline and end-point levels of serum iron and metabolic indices , and liver function tests were compared by Student 's paired t-test and the relationship between serum ferritin and the other variables during treatment was evaluated by linear regression analysis . FINDINGS AND CONCLUSIONS In the follow-up group , iron and metabolic indices did not change over time . Serum alanine aminotransferase , gamma-glutamyl transferase , cholesterol and triglycerides significantly decreased after iron depletion . Serum glucose , cholesterol , triglyceride , ferritin and liver function tests significantly decreased after dietary treatment . Transferrin saturation decreased below 20 % during phlebotomy treatment in 52 % of the patients . In conclusion , our results show that IR-HIO patients had relatively low amount of iron overload that seems not to increase even after a long follow-up period . Both venesections and diet improved iron , metabolic and hepatic indices . Data suggest a relationship between hepatic iron overload and insulin resistance , and a role for both iron overload and insulin resistance in hepatocellular damage . The behaviour of iron indices during venesections suggests an impaired iron release from hepatic cells Patients with chronic hepatitis C and low serum and hepatic iron stores may have an improved response to interferon ( IFN ) . We tested whether iron reduction before and during IFN therapy would lead to an improved sustained biochemical and virological response compared with IFN alone . Eighty-two previously untreated patients with chronic hepatitis C were r and omized to either : group A IFN-alpha2b 3 MU 3 times per week for 6 months , or group B iron reduction before and during IFN-alpha2b 3 MU 3 times per week for 6 months . Group B patients had lower mean serum alanine transaminase ( ALT ) levels than group A patients during treatment and follow-up . Group B patients had significantly lower mean hepatitis C virus (HCV)-RNA levels at treatment weeks 4 and 12 ( P < .05 ) . Serum HCV RNA was undetectable at the end of treatment in 15 group B patients compared with 7 group A patients ( P = .03 ) ; 7 group B patients and 3 group A patients had persistently undetectable serum HCV RNA 24 weeks after the end of therapy ( P = .20 ) . Paired pre- and posttreatment liver biopsies in 18 group B patients demonstrated significant improvements in 2 of the 3 inflammation scores of the Knodell histological activity index ( P < . 05 ) . No changes occurred in the paired biopsies from 15 group A patients . We conclude that iron reduction via therapeutic phlebotomy improves the end-of-treatment virological and histological response to short-term IFN therapy . Additional studies are needed to determine if iron reduction in combination with higher doses or longer duration of IFN may be of benefit OBJECTIVE : There is considerable evidence that iron is a risk factor for liver injury in chronic hepatitis C. Known as iron reduction therapy , phlebotomy reduces serum ALT activity . This effect might continue with maintenance phlebotomy and result in slower progression of liver fibrosis . METHODS : We examined the biochemical parameters and liver histology of patients with chronic hepatitis C treated by maintenance phlebotomy . For biochemical evaluation , 25 patients were treated by initial phlebotomy to reduce serum ferritin levels to 10 ng/ml or less and then observed for 5 yr with maintenance phlebotomy to maintain the iron-deficient state . For histological evaluation , liver biopsies were performed before and after the study period in 13 of the patients . Thirteen patients who were virological nonresponders to interferon alone and had undergone second liver biopsies after more than 3 yr served as histological controls . RESULTS : Serum aminotransferase levels were decreased significantly by initial phlebotomy and remained at the same levels during the study period ( p < 0.05 ) . The grading scores were improved significantly in the study group ( p < 0.05 ) and unchanged in the controls . The staging scores remained unchanged in the study group but were increased in the controls ( p < 0.005 ) . Disease progression was significantly different between the two groups ( p < 0.05 ) . CONCLUSIONS : These results suggest that phlebotomy with maintenance lowers serum aminotransferase levels , improves liver inflammation , and suppresses the progression of liver fibrosis in chronic hepatitis Iron is implicated in the pathogenesis of liver injury and insulin resistance ( IR ) and thus phlebotomy has been proposed as a treatment for nonalcoholic fatty liver disease ( NAFLD ) . We performed a prospect i ve 6‐month r and omized , controlled trial examining the impact of phlebotomy on the background of lifestyle advice in patients with NAFLD . Primary endpoints were hepatic steatosis ( HS ; quantified by magnetic resonance imaging ) and liver injury ( determined by alanine aminotransaminase [ ALT ] and cytokeratin‐18 [ CK‐18 ] ) . Secondary endpoints included insulin resistance measured by the insulin sensitivity index ( ISI ) and homeostasis model of assessment ( HOMA ) , and systemic lipid peroxidation determined by plasma F2‐isoprostane levels . A total of 74 subjects were r and omized ( 33 phlebotomy and 41 control ) . The phlebotomy group underwent a median ( range ) of 7 ( 1‐19 ) venesection sessions and had a significantly greater reduction in ferritin levels over 6 months , compared to controls ( −148 ± 114 vs. −38 ± 89 ng/mL ; P < 0.001 ) . At 6 months , there was no difference between phlebotomy and control groups in HS ( 17.7 % vs. 15.5 % ; P = 0.4 ) , serum ALT ( 36 vs. 46 IU/L ; P = 0.4 ) , or CK‐18 levels ( 175 vs. 196 U/L ; P = 0.9 ) . Similarly , there was no difference in end‐of‐ study ISI ( 2.5 vs. 2.7 ; P = 0.9 ) , HOMA ( 3.2 vs. 3.2 ; P = 0.6 ) , or F2‐isoprostane levels ( 1,332 vs. 1,190 pmmol/L ; P = 0.6 ) between phlebotomy and control groups . No differences in any endpoint were noted in patients with hyperferritinemia at baseline . Among patients undergoing phlebotomy , there was no correlation between number of phlebotomy sessions and change in HS , liver injury , or IR from baseline to end of study . Conclusion : Reduction in ferritin by phlebotomy does not improve liver enzymes , hepatic fat , or IR in subjects with NAFLD . ( Hepatology 2015;61:1555–1564 Elevated iron indices are described in non‐alcoholic fatty liver disease and iron reduction has been suggested as a potential therapy AIM To compare iron depletion to lifestyle changes alone in patients with severe nonalcoholic fatty liver disease ( NAFLD ) and hyperferritinemia , a frequent feature associated with more severe liver damage , despite at least 6 mo of lifestyle changes . METHODS Eligible subjects had to be 18 - 75 years old who underwent liver biopsy for ultrasonographically detected liver steatosis and hyperferritinemia , ferritin levels ≥ 250 ng/mL , and NAFLD activity score > 1 . Iron depletion had to be achieved by removing 350 cc of blood every 10 - 15 d according to baseline hemoglobin values and venesection tolerance , until ferritin < 30 ng/mL and /or transferrin saturation ( TS ) < 25 % . Thirty-eight patients were r and omized 1:1 to phlebotomy ( n = 21 ) or lifestyle changes alone ( n = 17 ) . The main outcome of the study was improvement in liver damage according to the NAFLD activity score at 2 years , secondary outcomes were improvements in liver enzymes [ alanine aminotransferases ( ALT ) , aspartate aminotransferase ( AST ) , and gamma-glutamyl-transferases ( GGT ) ] . RESULTS Phlebotomy was associated with normalization of iron parameters without adverse events . In the 21 patients compliant to the study protocol , the rate of histological improvement was higher in iron depleted vs control subjects ( 8/12 , 67 % vs 2/9 , 22 % , P = 0.039 ) . There was a better improvement in steatosis grade in iron depleted vs control patients ( P = 0.02 ) . In patients followed-up at two years ( n = 35 ) , ALT , AST , and GGT levels were lower in iron-depleted than in control patients ( P < 0.05 ) . The prevalence of subjects with improvement in histological damage or , in the absence of liver biopsy , ALT decrease ≥ 20 % ( associated with histological improvement in biopsied patients ) was higher in the phlebotomy than in the control arm ( P = 0.022 ) . The effect of iron depletion on liver damage improvement as assessed by histology or ALT decrease ≥ 20 % was independent of baseline AST/ALT ratio and insulin resistance ( P = 0.0001 ) . CONCLUSION Iron depletion by phlebotomy is likely associated with a higher rate of improvement of histological liver damage than lifestyle changes alone in patients with NAFLD and hyperferritinemia , and with amelioration of liver enzymes OBJECTIVE In a recent study , iron chelation with deferoxamine led to improvement of endothelial dysfunction in patients with coronary artery disease . We tested the hypothesis that decreasing circulating iron stores might improve vascular dysfunction in patients with type 2 diabetes and increased serum ferritin concentration . RESEARCH DESIGN AND METHODS A total of 28 type 2 diabetic male patients with serum ferritin levels > 200 ng/ml ( approximately 18 % of consecutive type 2 diabetic men attending our outpatient clinic ) were r and omized to iron depletion ( three extraction s of 500 ml blood at 2-week intervals ; group 1A ) or to observation ( group 1B ) . C282Y mutation was absent in all patients . Vascular reactivity ( high-resolution external ultrasound ) was evaluated at baseline and at 4 and 12 months thereafter . The two groups of patients were matched for age , BMI , pharmacological treatment , and chronic diabetic complications . RESULTS Endothelium-dependent vasodilation remained essentially unchanged in both groups of patients . In contrast , the vasodilation induced by glyceryl trinitrate ( GTN ) improved significantly after iron depletion ( P = 0.006 ) . These changes occurred in parallel to decreases in transferrin saturation index and HbA(1c ) levels ( -0.6 % , P < 0.05 ) only in group 1A patients . The best predictor of the modifications in endothelium-independent vasodilation was the change in HbA(1c ) levels . Changes in endothelium-independent vasodilation also correlated with the change in serum ferritin ( r = -0.45 , P = 0.04 ) . At 12 months , transferrin saturation index and GTN-induced vasodilation returned to values similar to those at baseline in both groups of subjects . CONCLUSIONS Iron depletion improves vascular dysfunction in type 2 diabetic patients with high ferritin concentrations . The mechanisms by which these changes occur should be further investigated BACKGROUND / AIM To test the short-term clinical usefulness of venesection associated with lifestyle counselling as against counselling alone on insulin resistance and liver enzymes in subjects with non-alcoholic fatty liver disease ( NAFLD ) , using a propensity score approach . METHODS We carried out a 6- to 8-month observational analysis of 198 NAFLD patients in three Italian referral centres ( 79 venesection and 119 counselling alone ) . Insulin resistance was measured by the homeostasis model assessment ( HOMA ) method . Logistic regression was used to identify factors associated with normal HOMA and normal alanine aminotransferase ( ALT ) at the end of observation . The results were adjusted for the propensity score to be enrolled in the venesection programme , based on clinical and laboratory data , including common HFE polymorphisms and liver biopsy ( available in 161 cases ) . RESULTS After adjustment for propensity and changes in BMI , venesection was significantly associated with normal HOMA [ all cases : odds ratio ( OR ) 3.00 ; 95 % confidence interval ( CI ) 1.51 - 5.97 ; cases with histology : OR 2.29 ; 95 % CI 1.08 - 4.87 ] and ALT within normal limits ( all cases : OR 2.56 ; 95 % CI 1.29 - 5.10 ; cases with histology : OR 2.81 ; 95 % CI 1.20 - 5 \n Output:\n " }, { "from": "agent", "value": "Even in the subgroup of patients with NAFLD and hyperferritinemia , phlebotomy did not improve the HOMA index , insulin level , ALT , or AST .\nPhlebotomy does not bring about significant improvement in indices of insulin resistance , liver enzymes , or liver histology in patients with DIOS and /or NAFLD compared to lifestyle changes alone .\nCurrent evidence does not support the use of phlebotomy in patients with DIOS or NAFLD" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Aim The aim of this study was to determine whether an educational intervention delivered by a computer aided learning package improved the sensitivity and specificity of dentists ' restorative treatment decisions Method The study was a r and omised controlled study using a Solomon three-group design . Ninety-five dentists were r and omly allocated to the three study groups . One group of dentists read the radiographs pre and post an educational intervention , a second group read the radiographs once , after the intervention , and a third group read the radiographs twice , but received no intervention . On each occasion the dentists read 24 surfaces on each of 15 radiographs and made 360 decisions on how certain they were about restoring the tooth surface . Comparisons of mean sensitivity , specificity and areas under ROC curves were made within and between the study groups . Kappa values were used to assess changes in the level of agreement between dentists . Results There were no significant changes in sensitivity , specificity or area under ROC curves caused by the intervention . There was no evidence that the level of agreement between the dentists improved after the intervention . Conclusion A computer aided learning package had no effect on dentists ' treatment decision-making behaviour The increasing number of geriatric dental patients and the development of treatment plans that require consideration of complex psychosocial , socioeconomic , and medical/medication factors necessitates a change in the traditional teaching of treatment planning . A computer-assisted instructional program was developed to simulate the dentist-geriatric patient interaction and to train students in clinical decision making for the geriatric patient . This study compared the effects of this program with a more traditional approach based on readings from the geriatric dentistry literature . Twenty third-year dental students were matched on grade point average and r and omly assigned to the computer or literature -based groups . They were pretested using a clinical analogue of a geriatric patient and then instructed to use either the computer or literature -based educational units . The students were then post-tested on a second clinical analogue . Students performed similarly at pretest . At post-test , both the computer and literature -based subjects were found to have acquired significantly greater evaluation points , to make fewer errors , and to design more involved treatment plans than at pretest . Comparison of computer and literature -based subjects ' performance revealed no significant main or interaction effects regarding type of educational unit used . Consistent nonsignificant trends were noted with the computer-based subjects out-performing literature -based subjects on each outcome variable . In addition , the computer-based subjects had more positive feelings about the educational unit than the literature -based subjects at a statistically significant level . These findings suggest that the computer program is an effective alternative method for developing clinical decision skills in students treating geriatric patients . ( ABSTRACT TRUNCATED AT 250 WORDS The purpose of this study was to test the hypothesis that CAI used at low cognitive levels is as effective and motivating as conventional teaching , while requiring fewer teacher re sources . Seventy-six chairside-assistant students were r and omly allocated to either a CAI-group or a control group receiving conventional teaching . The subject taught was the clinical armamentarium and its use . A performance and attitude test was given to both groups . Time used for constructing the CAI program and for conventional teaching was registered . The results confirmed the hypothesis PURPOSE Computer programs have been developed for removable partial denture ( RPD ) design , but their educational impact has never been investigated . This study measured the effectiveness of computer-based RPD design simulations in a traditional RPD design course for second-year dental students . MATERIAL S AND METHODS Thirty-six students were r and omly assigned to four groups , two simulation and two control groups , at the beginning of the RPD design module . A cross-over design compared the two strategies during laboratory exercises . First , the simulation group worked with the simulation , while the control group met in small-group seminars with faculty . Post-test 1 was given , and then students switched teaching methods and post-test 2 was given . Each post-test had two parts . Part 1 involved design ing an RPD based on specific patient criteria . Part 2 involved choosing the more correct of the two design s. RESULTS Results showed a significant difference ( p = .0072 ) in two of four test groups . Although it was an initial evaluation , the computer simulation was shown to be equivalent to faculty-led small-group seminars . Students also responded positively to a question naire on their perceived effectiveness of the simulations . CONCLUSIONS The results suggest that RPD design can be taught as effectively with computer-based simulations as with faculty-led seminars New technology may create additional opportunities for learning in dental education . One of these new features is a multimedia approach , courseware combining sound , text , stills and video with interactive learning . A multimedia program was developed to train dental students and dental practitioners in decision making and problem solving in endodontics . This study compared the effects of the multimedia program with a more traditional approach consisting of written information , without interaction . 28 , 4th-year dental students at the University of Kentucky in Lexington , KY , USA were r and omly assigned to the multimedia or the text-based groups . They were given a written pre-test using 2 cases of dental pain and were instructed to study independently using either the multimedia program ( group A ) or the written information ( group B ) . No restrictions were imposed on the amount of time to be invested , and the total study time was recorded for each student . 3 weeks after the pre-test , the students completed the post-test . A total of 18 students completed both the pre-test and the post-test and their scores were included in the final data . Statistical analysis of the average scores using paired t-tests revealed no significant difference between the performance of the students in either group , indicating that the multimedia approach to learning endodontic problem solving may successfully replace traditional learning strategies In a r and omized controlled trial , self-teaching booklets and computer media were evaluated for teaching diagnostic testing to dental students as a foundation for further development of clinical decision making skills . Effectiveness was assessed by pre- and post-tests . Reliability of these test instruments was examined by analyzing the pre- and post-test scores of 49 first year dental students who received no instruction . Forty-one second year dental students were exposed to clinical epidemiological principles applied to endodontic diagnosis through either self-teaching booklets or computer media . No statistically significant difference was found between the mean test scores of the students through self-teaching booklets and computer media . Although first and second year students showed a statistically significant improvement between the pre-test and post-test , the improvement in the second year class was greater . An addendum was later made to the main trial to compare the self-teaching booklet to the traditional lecture format in teaching endodontic diagnosis . Seventy-one third year dental students were exposed to these same material s through either a lecture or the self-teaching booklet and then similarly tested . There was no significant difference between the self-teaching booklet and traditional lecture for the third year students Hypertext is a non-linear method of text presentation . It necessitates the use of a computer to store data as a series of nodes that can be called up in any desired sequence and , as such , is a new form of discovery-based learning . This paper describes a Hypertext tutorial in cephalometrics and its subsequent testing on first-year clinical dental students . Students were divided into two groups : the first received a conventional lecture ; the second used the Hypertext tutorial . Testing was by means of conventional multiple choice questions . The results showed that there was no statistically significant difference between the two groups , although the computer tutor was shown more consistently to improve the knowledge of the students than did the conventional lecture . Most students who used the computer program found it enjoyable , but time consuming ; less than half found it easy to follow \n Output:\n " }, { "from": "agent", "value": "Our study concluded that CAL is as effective as other methods of teaching and can be used as an adjunct to traditional education or as a means of self-instruction" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Shock-absorbing and biomechanic shoe orthoses are frequently used in the prevention and treatment of back and lower extremity problems . One review concludes that the former is clinical ly effective in relation to prevention , whereas the latter has been tested in only 1 r and omized clinical trial , concluding that stress fractures could be prevented . OBJECTIVES To investigate if biomechanic shoe orthoses can prevent problems in the back and lower extremities and if reducing the number of days off-duty because of back or lower extremity problems is possible . DESIGN Prospect i ve , r and omized , controlled intervention trial . STUDY SUBJECTS One female and 145 male military conscripts ( aged 18 to 24 years ) , representing 25 % of all new conscripts in a Danish regiment . METHOD Health data were collected by question naires at initiation of the study and 3 months later . Custom-made biomechanic shoe orthoses to be worn in military boots were provided to all in the study group during the 3-month intervention period . No intervention was provided for the control group . Differences between the 2 groups were tested with the chi-square test , and statistical significance was accepted at P < .05 . Risk ratio ( RR ) , risk difference ( ARR ) , numbers needed to prevent ( NNP ) , and cost per successfully prevented case were calculated . OUTCOME VARIABLES Outcome variables included self-reported back and /or lower extremity problems ; specific problems in the back or knees or shin splints , Achilles tendonitis , sprained ankle , or other problems in the lower extremity ; number of subjects with at least 1 day off-duty because of back or lower extremity problems and total number of days off-duty within the first 3 months of military service because of back or lower extremity problems . RESULTS Results were significantly better in an actual-use analysis in the intervention group for total number of subjects with back or lower extremity problems ( RR 0.7 , ARR 19 % , NNP 5 , cost 98 US dollars ) ; number of subjects with shin splints ( RR 0.2 , ARR 19 % , NNP 5 , cost 101 US dollars ) ; number of off-duty days because of back or lower extremity problems ( RR 0.6 , ARR < 1 % , NNP 200 , cost 3750 US dollars ) . In an intention-to-treat analysis , a significant difference was found for only number of subjects with shin splints ( RR 0.3 , ARR 18 % , NNP 6 cost 105 US dollars ) , whereas a worst-case analysis revealed no significant differences between the study groups . CONCLUSIONS This study shows that it may be possible to prevent certain musculoskeletal problems in the back or lower extremities among military conscripts by using custom-made biomechanic shoe orthoses . However , because care-seeking for lower extremity problems is rare , using this method of prevention in military conscripts would be too costly . We also noted that the choice of statistical approach determined the outcome Orthotic insoles are suggested to prevent low back pain . This r and omized controlled study assessed if customised orthotic insoles prevent low back pain . Healthy military conscripts ( n = 228 ; mean age 19 years , range 18–29 ) were r and omly assigned to use either customised orthotic insoles ( treatment group , n = 73 ) or nothing ( control group , n = 147 ) . The main outcome measure was low back pain requiring a physician visit and result ing in minimum 1 day suspension from military duty . Twenty-four ( 33 % ) treated subjects and 42 ( 27 % ) control subjects were suspended from duty due to low back pain ( p = 0.37 ; risk difference 4.3 % ; 95 % CI : −8.7 to 17.3 % ) . Mean suspension duration was 2 days ( range 1–7 ) in both groups . Four ( 5 % ) treated subjects and eight ( 5 % ) control subjects were released from duty due to persistent low back pain ( p = 0.92 ; risk difference 0 % ; 95 % CI : −6 to 6 % ) . Use of orthotic insoles is therefore not recommended to prevent physical stress-related low back pain Study design : r and omized , double-blinded , clinical trial . Background : Low back pain is one of the commonest disorders affecting the back . The literature reflects how over time excessive pronation of the foot has become to be recognized as linked to chronic low back pain , and how the problem can evolve for the better with the use of compensating foot orthoses . Objectives : The main objective of this study is to answer the question of whether the use of a certain type of custom-made foot orthosis alleviates low back pain . Material and methods : In a sample of 51 participants with excessive subtalar pronation and chronic low back pain ( 43 women and 8 men ) , the effect of custom-made foot orthoses in low back pain was studied . The study design was a r and omized , double-blinded , clinical trial with two groups : experimental , treated with the custom-made foot orthoses , and control , treated with a placebo . Low back pain was evaluated by a visual analog scale for pain and Oswestry ’s Disability Index Question naire for lower back pain at two moments — on the day of inclusion in the study and after 4 weeks of treatment . Results : The evolution of the low back pain showed significant differences in the experimental group , showing a significant reduction of pain and disability ( p < 0.001 , visual analog scale ; p < 0.001 , Oswestry ’s Index ) . Conclusions : In the sample studied , the use of custom-made foot orthoses to control foot pronation had a short-term effect in reduction of perceived low back pain . Clinical relevance If subtalar joint hyperpronation plays a fundamental role in the pathomechanics of lower limb , and this can facilitate the development of low back pain , then controlling the abnormal mobility of subtalar joint by means of foot orthoses should improve this symptom . This article could help solve this controversy 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 Study Design . R and omized controlled trial . Objectives . To determine if the use of custom shoe orthoses can lessen the incidence of weight bearing-induced back pain . Summary of Background Data . The scientific basis for the use of orthoses to prevent back pain is based principally on studies that show that shoe orthoses can attenuate the shock wave generated at heel strike . The repetitive impulsive loading that occurs because of this shock wave can cause wear of the mechanical structures of the back . Previous r and omized studies showed mixed results in preventing back pain , were not blinded , and used orthoses for only short periods of time . Methods . A total of 404 eligible new infantry recruits without a history of prior back pain were r and omly assigned to received either custom soft , semirigid biomechanical , or simple shoe inserts without supportive or shock absorbing qualities . Recruits were review ed biweekly by an orthopaedist for back signs and symptoms during the course of 14 weeks of basic training Results . The overall incidence of back pain was 14 % . By intention-to treat and per- protocol analyses , there was no statistically significant difference between the incidence of either subjective or objective back pain among the 3 treatment groups . Significantly more recruits who received soft custom orthoses finished training in their assigned orthoses ( 67.5 % ) than those who received semirigid biomechanical orthoses ( 45.5 % ) or simple shoe inserts ( 48.6 % ) , P = 0.001 . Conclusions . The results of this study do not support the use of orthoses , either custom soft or semirigid biomechanical , as prophylactic treatment for weight bearing-induced back pain . Custom soft orthoses had a higher utilization rate than the semirigid biomechanical or simple shoe inserts . The pretraining physical fitness and sports participation of recruits were not related to the incidence of weight bearing-induced back pain Objective To compare the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome with flat inserts or physiotherapy , and to investigate the effectiveness of foot orthoses plus physiotherapy . Design Prospect i ve , single blind , r and omised clinical trial . Setting Single centre trial within a community setting in Brisbane , Australia . Participants 179 participants ( 100 women ) aged 18 to 40 years , with a clinical diagnosis of patellofemoral pain syndrome of greater than six weeks ’ duration , who had no previous treatment with foot orthoses or physiotherapy in the preceding 12 months . Interventions Six weeks of physiotherapist intervention with off the shelf foot orthoses , flat inserts , multimodal physiotherapy ( patellofemoral joint mobilisation , patellar taping , quadriceps muscle retraining , and education ) , or foot orthoses plus physiotherapy . Main outcome measures Global improvement , severity of usual and worst pain over the preceding week , anterior knee pain scale , and functional index question naire measured at 6 , 12 , and 52 weeks . Results Foot orthoses produced improvement beyond that of flat inserts in the short term , notably at six weeks ( relative risk reduction 0.66 , 99 % confidence interval 0.05 to 1.17 ; NNT 4 ( 99 % confidence interval 2 to 51 ) . No significant differences were found between foot orthoses and physiotherapy , or between physiotherapy and physiotherapy plus orthoses . All groups showed clinical ly meaningful improvements in primary outcomes over 52 weeks . Conclusion While foot orthoses are superior to flat inserts according to participants ’ overall perception , they are similar to physiotherapy and do not improve outcomes when added to physiotherapy in the short term management of patellofemoral pain . Given the long term improvement observed in all treatment groups , general practitioners may seek to hasten recovery by prescribing prefabricated orthoses . Trial registration Australian Clinical Trials Registry ACTRN012605000463673 and Clinical Trials.gov NCT00118521 OBJECTIVES The purpose of this pilot study was to investigate the feasibility of a r and omized clinical trial of shoe orthotics for chronic low back pain . METHODS The study recruited 50 patients with chronic low back pain through media advertising in a midwestern suburban area . Medical history and a low back examination were completed at a chiropractic clinic . Subjects were r and omized to either a treatment group receiving custom-made shoe orthotics or a wait-list control group . After 6 weeks , the wait-list control group also received custom-made orthotics . This study measured change in perceived pain levels ( Visual Analog Scale ) and functional health status ( Oswestry Disability Index ) in patients with chronic low back pain at the end of 6 weeks of orthotic treatment compared with no treatment and at the end of 12 weeks of orthotic treatment . RESULTS This study showed changes in back pain and disability with the use of shoe orthotics for 6 weeks compared with a wait-list control group . It appears that improvement was maintained through the 12-week visit , but the subjects did not continue to improve during this time . CONCLUSIONS This pilot study showed that the measurement of shoe orthotics to reduce low back pain and discomfort after 6 weeks of use is feasible . A larger clinical trial is needed to verify these results Soccer referees participating in large soccer tournaments may develop overuse injuries . In this study the effect of shock absorbing heel inserts in the incidence of soreness was investigated . Forty-eight referees were r and omly selected to wear shock absorbing heel inserts ( SAH ) in the 5 day-tournament , while 43 referees were the control group . A daily question naire inquiring about complaints from the locomotive system was completed for each referee and in case of any soreness they were examined by doctors to document and classify the anatomical site . Calf , thigh , back , achilles tendon and knee were the most common localizations of overuse symptoms . The incidence of soreness in achilles tendon , calf and back were significantly reduced by the use of ( SAH ) inserts 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 instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological \n Output:\n " }, { "from": "agent", "value": "Conclusions There is insufficient evidence to support the use of insoles or foot orthoses as either a treatment for LBP or in the prevention of LBP .\nFuture research should concentrate on identification of LBP patients most suited to foot orthoses or insole treatment , as there is some evidence that trials structured along these lines have a greater effect on reducing LBP" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE Retrospective studies suggest that laparoscopic excision of endometriomas is associated with a reduced responsiveness to ovarian hyperstimulation . In this study , we prospect ively evaluated ovarian response to hyperstimulation in women selected for in vitro fertilization and intracytoplasmic sperm injection cycles who previously underwent laparoscopic enucleation of a monolateral endometrioma . STUDY DESIGN Operated and contralateral intact ovaries of the same patient were compared in terms of number of follicles , number of oocytes retrieved , fertilization rate , and rate of high- quality embryos . RESULTS Thirty-eight subjects were included . A reduced number of dominant follicles , oocytes , embryos , and high- quality embryos was observed in the operated gonad . The mean percentage of reduction was 60 % ( 95 % confidence interval 38 - 81 % ) , 53 % ( 95 % confidence interval 30 - 75 % ) , 55 % ( 95 % confidence interval 28 - 81 % ) , and 52 % ( 95 % confidence interval 17 - 87 % ) , respectively . Fertilization rate and rate of good- quality embryos were similar . CONCLUSION Laparoscopic excision of endometriomas is associated with a quantitative but not a qualitative damage to ovarian reserve Laparoscopic ovarian cystectomy is recommended for surgical procedure of endometrioma . The negative impact on ovarian reserve following removal had been documented . Little evidence had been reported for nonovarian originated effects . Objective . To evaluate the impact of laparoscopic ovarian cystectomy for endometrioma on ovarian reserve , measured by serum antimullerian hormone ( AMH ) , compared to nonovarian pelvic surgery . Material s and Methods . A prospect i ve study was conducted . Women who underwent laparoscopic ovarian cystectomy ( LOC ) and laparoscopic nonovarian pelvic surgery ( NOS ) were recruited and followed up through 6 months . Clinical baseline data and AMH were evaluated . Results . 39 and 38 participants were enrolled in LOC and NOS groups , respectively . Baseline characteristics ( age , weight , BMI , and height ) and preoperative AMH level between 2 groups were not statistically different . After surgery , AMH of both groups decreased since the first week , at 1 month and at 3 months . However , as compared to the LOC group at 6 months after operation , the mean AMH of the NOS group had regained its value with a highly significant difference . Conclusion . This study demonstrated the negative impact of nonovarian or indirect effects of laparoscopic surgery to ovarian reserve . The possible mechanisms are necessary for more investigations AIM We aim ed to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian endometriotic cyst resection on ovarian reserve by comparing the rates of decrease in anti-Müllerian hormone ( AMH ) . METHODS A r and omized prospect i ve data collection was made on women aged 19 - 45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions ( n = 80 ) , Kangbuk Samsung Hospital , Seoul , Korea or National Health Insurance Service Ilsan Hospital , Goyang , Korea , from January 2014 to April 2016 . Patients were r and omly divided into two groups treated with either a topical hemostatic sealant or bipolar coagulation for hemostasis . The hemostatic group was r and omized to the FloSeal or TachoSil subgroups . Preoperative and 3-month postoperative AMH levels were checked and the rates of decrease of AMH were compared . All patients enrolled were treated with dienogest ( Visanne ) for 6 - 12 months . None were lost to follow-up at postoperative 3 months , but about one-third of the patients had been lost to follow-up by 6 - 12 months . RESULTS AMH was significantly decreased in both groups 3 months postoperatively ; however , the rate of decrease in the bipolar coagulation group was greater than that in the hemostatic sealant group , 41.9 % ( interquartile range [ IQR ] , 22.29 - 65.24 ) versus 18.1 % ( IQR , 10.94 - 29.90 ) , P = 0.007 . Between the two hemostatic subgroups , there was no significant difference in AMH decrease rate , 14.95 % ( IQR , 11.34 - 21.21 ) versus 18.1 % ( IQR 9.76 - 40.70 ) , P = 0.204 . CONCLUSION Hemostatic sealants may be an alternative to bipolar coagulation for preservation of ovarian reserve after laparoscopic ovarian cystectomy for endometriosis STUDY QUESTION Is there an association between the endometriosis phenotype and presentation with infertility ? SUMMARY ANSWER In a population of operated patients with histologically proven endometriosis , ovarian endometrioma ( OMA ) per se is not associated with an increased risk of presentation with infertility , while previous surgery for endometriosis was identified as a risk factor for infertility . WHAT IS KNOWN ALREADY The increased prevalence of endometriosis among subfertile women indicates that endometriosis impairs reproduction for reasons that are not completely understood . STUDY DESIGN , SIZE , DURATION This was an observational , cross-sectional study using data prospect ively collected in all non-pregnant patients aged between 18 and 42 years , who were surgically explored for benign gynaecological conditions at our institution between January 2004 and March 2013 . For each patient , a st and ardized question naire was completed during a face-to-face interview conducted by the surgeon during the month preceding surgery . PARTICIPANTS / MATERIAL S , SETTING , METHODS Surgery was performed in 2208 patients , of which 2066 signed their informed consent . Of the 1059 women with a visual diagnosis of endometriosis , 870 had histologically proven endometriosis and complete treatment for their endometriotic lesions , including 307 who presented with infertility . Univariate analysis and multiple logistic regression analysis were performed to determine factors associated with infertility . MAIN RESULTS AND THE ROLE OF CHANCE The following variables were identified as risk factors for endometriosis-related infertility : age > 32 years ( odds ratio [ OR ] = 1.9 ; 95 % confidence interval [ CI ] : 1.4 - 2.4 ) , previous surgery for endometriosis ( OR = 1.9 ; 95 % CI : 1.3 - 2.2 ) , as well as peritoneal superficial endometriosis ( OR = 3.1 ; 95 % CI : 1.9 - 4.9 ) ; Conversely , previous pregnancy was associated with a lower rate of infertility ( OR = 0.7 ; 95 % CI : 0.6 - 0.9 and OR = 0.6 ; 95 % CI : 0.4 - 0.9 , respectively ) . OMA is not selected as a significant risk factor for infertility . LIMITATIONS , REASON FOR CAUTION The selection of our study population was based on a surgical diagnosis . We can not exclude that infertile women with OMA associated with a diminished ovarian reserve , as assessed during their infertility work-up , were referred less frequently to surgery and might therefore be underrepresented . In addition we can not exclude that our group of infertile women present associated other causes of infertility . WIDER IMPLICATION S OF THE FINDINGS Identification of risk and preventive factors of endometriosis-related infertility can help improve clinical and surgical management of endometriosis in the setting of infertility . STUDY FUNDING /COMPETING INTERESTS None . TRIAL REGISTRATION NUMBER None Objective . To evaluate whether a change takes place in antimullerian hormone ( AMH ) levels reflecting the ovarian reserve after laparoscopic endometrioma stripping surgery and to demonstrate if there is any correlation between AMH levels and the sizes of endometriomas . Method . Fourty-seven women participated as the study group in this prospect i ve controlled trial , 33 of whom ( 70.2 % ) had unilateral and 14 ( 29.7 % ) of whom had bilateral endometriomas . Pre- and post-operative serum AMH levels were measured and compared with 17 normo-ovulatory control cases and also correlated with endometrioma sizes . Result ( s ) . Mean pre-operative AMH levels of the study group and the normo-ovulatory control cases did not reveal a statistically significant difference ( 1.62 ± 1.09 ng/ml and 2.06 ± 0.51 ng/ml , P > 0.05 ) . Mean level of post-operative serum AMH of the study group decreased from 1.62 ± 1.09 to 1.39 ± 1.16 . However , this reduction was not statistically significant . ( P > 0.05 ) . Pre- and post-operative AMH levels do not reveal a correlation with the size of endometrioma in both group of patients with either unilateral or bilateral endometrioma . Conclusion ( s ) . The presence of the endometrioma does not impair the AMH levels . Laparoscopic endometrioma stripping surgery do not appear to cause a damage in the AMH secreting healthy ovarian tissue , in the short-term follow-up . Laparoscopic stripping surgery of endometriomas in experienced h and s is currently a valid approach OBJECTIVE To investigate whether the serum antimüllerian hormone ( AMH ) levels recover within 1 year after cystectomy for endometriomas , and to analyze the pattern of sequential changes in the serum AMH levels . DESIGN Prospect i ve study . SETTING University hospital . PATIENT(S ) Thirty-nine patients undergoing cystectomy for unilateral endometrioma ( n = 22 ) and bilateral endometriomas ( n = 17 ) . INTERVENTION(S ) Serum sample s collected 2 weeks before , and 1 month and 1 year after surgery were assayed for AMH levels . MAIN OUTCOME MEASURE(S ) Assessment of the ovarian reserve damage based on alterations in the serum AMH levels and the association with parameters of endometriosis and surgery for endometriomas . RESULT ( S ) The median AMH levels were 3.56 , 1.90 , and 2.10 ng/mL before , 1 month after , and 1 year after surgery , respectively . Twenty patients showed higher AMH levels 1 year after surgery than 1 month after surgery ( increase group ) ; 19 patients showed lower AMH levels ( decrease group ) . We found a statistically significant difference in the number of follicles removed by surgery between the two groups . CONCLUSION ( S ) The decrease in the serum AMH levels caused by cystectomy can recover . Our results suggest that removal of ovarian cortex might be involved in the decrease of the ovarian reserve just after surgery , and that a continuous decrease of the ovarian reserve after cystectomy might be attributed to other mechanisms Background Endometriosis is a well-known cause of infertility , and the anti-Mullerian hormone ( AMH ) is an accepted biomarker of ovarian reserve and response to artificial reproductive technology procedures . The present study was a prospect i ve analysis of age-dependent AMH serum concentration in women with bilateral and unilateral ovarian endometriomas before therapy onset compared with healthy controls . Methods This prospect i ve cross-sectional study included 384 women aged 18–48 years . AMH serum concentration was assessed between days 3 and 6 of the menstrual cycle in 78 patients with bilateral and 157 patients with unilateral ovarian endometriomas and compared with 149 healthy controls . Ovarian endometriosis was confirmed histopathologically , and data were presented as medians with interquartile range ( IQR ) . Results Stage III endometriosis was diagnosed in 53.2 % , stage IV in 18.3 % , stage V in 23.4 % and stage VI in 5.4 % of the patients . Patients with bilateral ovarian endometriomas showed the lowest median AMH levels compared with patients suffering from unilateral ovarian endometriosis ( 0.55 ; IQR : 0.59 vs. 2.00 ; IQR : 2.80 ; p < 0.001 ) and the control group ( 0.55 ; IQR : 0.59 vs. 2.84 ; IQR : 3.2 ; p < 0.001 ) . Median AMH concentration values were not significantly different between patients with unilateral ovarian endometriosis and the healthy controls ( 2.00 ; IQR : 2.80 vs. 2.84 ; IQR : 3.2 ; p = 0.182 ) . A strongly negative correlation between AMH levels and age was confirmed in healthy individuals ( R = −0.834 ; p < 0.001 ) and women with unilateral ovarian endometriomas ( R = −0.774 ; p < 0.001 ) . Patients with bilateral ovarian endometriosis showed a significantly negative but only moderate correlation between AMH levels and age ( R = −0.633 ; p < 0.001 ) , which was significantly lower than in the healthy controls ( R = −0.633 vs. R = −0.834 ; p = 0.0 \n Output:\n " }, { "from": "agent", "value": "The pre-operative weighted mean difference ( WMD ) showed that serum AMH levels did not differ significantly between the groups .\nWIDER IMPLICATION S Our results challenge the concept that endometrioma per se adversely affects ovarian reserve , whereas endometrioma cystectomy , especially as bilateral operation , has a deleterious and sustained effect on ovarian reserve .\nAMH seems to be a more appropriate biomarker of ovarian reserve than AFC in cases with endometrioma ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Purpose To compare the impact of sustained supplementation using different macular carotenoid formulations on macular pigment ( MP ) and visual function in early age-related macular degeneration ( AMD ) . Patients and methods Sixty-seven subjects with early AMD were r and omly assigned to : Group 1 ( 20 mg per day lutein ( L ) , 0.86 mg per day zeaxanthin ( Z ) ; Ultra Lutein ) , Group 2 ( 10 mg per day meso-zeaxanthin ( MZ ) , 10 mg per day L , 2 mg per day Z ; Macushield ; Macuhealth ) , Group 3 ( 17 mg per day MZ , 3 mg per day L , 2 mg per day Z ) . MP was measured using customised heterochromatic flicker photometry and visual function was assessed by measuring contrast sensitivity ( CS ) and best-corrected visual acuity ( BCVA ) . AMD was grade d using the Wisconsin Age-Related Maculopathy Grading System ( AREDS 11-step severity scale ) . Results At 3 years , a significant increase in MP from baseline was observed in all groups at each eccentricity ( P<0.05 ) , except at 1.75 ° in Group 1 ( P=0.160 ) . Between 24 and 36 months , significant increases in MP at each eccentricity were seen in Group 3 ( P<0.05 for all ) , and at 0.50 ° in Group 2 ( P<0.05 ) , whereas no significant increases were seen in Group 1 ( P>0.05 for all ) . At 36 months , compared with baseline , the following significant improvements ( P<0.05 ) in CS were observed : Group 2—1.2 , 6 , and 9.6 cycles per degree ( c.p.d . ) ; Group 1—15.15 c.p.d . ; and Group 3—6 , 9.6 , and 15.15 c.p.d . No significant changes in BCVA , or progression to advanced AMD , were observed . Conclusion In early AMD , MP can be augmented with a variety of supplements , although the inclusion of MZ may confer benefits in terms of panprofile augmentation and in terms of CS enhancement BACKGROUND The relation between intakes of total fat and specific types of fat and age-related macular degeneration ( AMD ) remains unclear . OBJECTIVE Our objective was to examine prospect ively the association between fat intake and AMD . DESIGN We conducted a prospect i ve follow-up study of participants in the Nurses ' Health Study and the Health Professionals Follow-up Study . At baseline ( 1984 for women and 1986 for men ) , the study included 42743 women and 29746 men aged > or = 50 y with no diagnosis of AMD who were followed until 1996 . Fat intake was assessed with a food-frequency question naire . RESULTS We accrued 567 patients with AMD with a visual loss of 20/30 or worse . The pooled multivariate relative risk ( RR ) for the highest compared with the lowest quintile of total fat intake was 1.54 ( 95 % CI : 1.17 , 2.01 ; P for trend = 0.008 ) . Linolenic acid was positively associated with risk of AMD ( top versus bottom quintile of RR : 1.49 ; 95 % CI : 1.15 , 1.94 ; P for trend = 0.0009 ) . Docosahexaenoic acid had a modest inverse relation with AMD ( top versus bottom quintile of RR : 0.70 ; 95 % CI : 0.52 , 0.93 ; P for trend = 0.05 ) , and > 4 servings of fish/wk was associated with a 35 % lower risk of AMD compared with < or = 3 servings/mo ( RR : 0.65 ; 95 % CI : 0.46 , 0.91 ; P for trend = 0.009 ) . CONCLUSIONS Total fat intake was positively associated with risk of AMD , which may have been due to intakes of individual fatty acids , such as linolenic acid , rather than to total fat intakes per se . A high intake of fish may reduce the risk of AMD Background The primary objective of LUTEGA is to determine the long-term effect of a supplementation with fixed combination of lutein , zeaxanthin , omega-3-longchain-polyunsaturated-fatty-acids ( O-3-LCPUFAs ) and antioxidants on macular pigment optical density ( MPOD ) in patients with non-exudative age-related macular degeneration ( AMD ) . Methods The LUTEGA study is a double-blind , placebo-controlled clinical trial . 172 patients with non-exudative AMD were enrolled and r and omized to three treatment arms . Supplementation included either once ( dosage D1 ) or twice daily ( dosage D2 ) of 10 mg L / 1 mg Z/ O-3-LCPUFAs ( thereof 100 mg DHA , 30 mg EPA)/ antioxidants , or placebo ( P ) . After best-corrected visual acuity ( BCVA ) test , blood sample was collected and MPOD was measured using the 1-wavelength-reflection method and recording reflection images at 480 nm ( modified VisucamNM/FA , Carl Zeiss Meditec , Germany ) . During 1 year of intervention , AMD patients were followed up after 1 , 3 , 6 and 12 months . 145 AMD patients ( D1 = 50 , D2 = 55 , P = 40 ) completed the study . Results After 12 months of intervention , the MPOD parameters ( volume , area , maxOD , meanOD ) increased significantly in treatment arms D1 and D2 ( p < 0.001 ) . Volume of MPOD showed the highest within-group difference and increased significantly in D1 and D2 , and decreased significantly in P ( p = 0.041 ) . Between-group comparison of absolute changes of all MPOD parameters were significantly different between D1 and P as well as D2 and P with p < 0.001 at end point ( t = 12 ) . BCVA , measured in log MAR , improved in D1 and in D2 ( p < 0.001 ) . After 12 months of intervention , the mean improvement in BCVA was significant in D2 ( p = 0.006 ) and D1 ( p = 0.038 ) compared to P. Conclusions The supplementation of L , Z , O-3-LCPUFAs and antioxidants result ed in considerable increase in MPOD . There was no difference in accumulation of MPOD between both dosages . Thus , we believe that the used supplementation with L and Z seems to reach a saturation level in retinal cell structure . Additionally , the constant supplementation of L , Z , O-3-LCPUFAs and antioxidants in AMD patients seems to be useful , because MPOD reduces without supplementation . We conclude that the supplementation caused an increase of MPOD , which results in an improvement and stabilization in BCVA in AMD patients . Thus , a protective effect on the macula in AMD patients is assumed Abstract Purpose : The Central Retinal Enrichment Supplementation Trials ( CREST ) aim to investigate the potential impact of macular pigment ( MP ) enrichment , following supplementation with a formulation containing 10 mg lutein ( L ) , 2 mg zeaxanthin ( Z ) and 10 mg meso-zeaxanthin ( MZ ) , on visual function in normal subjects ( Trial 1 ) and in subjects with early age-related macular degeneration ( AMD ; Trial 2 ) . Methods : CREST is a single center , double-blind , r and omized clinical trial . Trial 1 ( 12-month follow-up ) subjects are r and omly assigned to a formulation containing 10 mg L , 10 mg MZ and 2 mg Z ( n = 60 ) or placebo ( n = 60 ) . Trial 2 ( 24-month follow-up ) subjects are r and omly assigned to a formulation containing 10 mg L , 10 mg MZ , 2 mg Z plus 500 mg vitamin C , 400 IU vitamin E , 25 mg zinc and 2 mg copper ( Intervention A ; n = 75 ) or 10 mg L and 2 mg Z plus 500 mg vitamin C , 400 IU vitamin E , 25 mg zinc and 2 mg copper ( Intervention B ; n = 75 ) . Contrast sensitivity ( CS ) at 6 cycles per degree represents the primary outcome measure in each trial . Secondary outcomes include : CS at other spatial frequencies , MP , best-corrected visual acuity , glare disability , photostress recovery , light scatter , cognitive function , foveal architecture , serum carotenoid concentrations , and subjective visual function . For Trial 2 , AMD morphology , reading speed and reading acuity are also being recorded . Conclusions : CREST is the first study to investigate the impact of supplementation with all three macular carotenoids in the context of a large , double-blind , r and omized clinical trial BACKGROUND Individuals with early or intermediate stages of age-related macular degeneration ( AMD ) make up a large , growing segment of the elderly population . Evidence is sparse regarding modifiable factors that may decrease the risk of progression to the advanced forms of AMD . OBJECTIVE To advise patients with a high risk for advanced forms of AMD about preventive measures through our evaluation of the relationship between dietary fat intake and the progression of early or intermediate AMD to the advanced stages of the disease associated with visual loss . DESIGN A prospect i ve cohort study with an average follow-up time of 4.6 years . SETTING A hospital-based clinical retinal practice specializing in macular degeneration . Patients The 261 participants were aged 60 years and older and had some sign of nonexudative AMD and visual acuity of 20/200 or better in at least 1 eye . Main Outcome Measure Progression to advanced AMD , which was defined as having geographic atrophy or neovascular disease . RESULTS Higher total fat intake increased the risk of progression to the advanced forms of AMD , with a relative risk ( RR ) of 2.90 ( 95 % confidence interval , 1.15 - 7.32 ) for the highest fat-intake quartile relative to the lowest fat-intake quartile , after controlling for other factors ( P trend = .01 ) . Animal fat intake was associated with a 2-fold increased risk of progression ( RR , 2.29 for the highest quartile compared with the lowest quartile ; 95 % confidence interval , 0.91 - 5.72 ) , although the trend for increasing risk with higher animal fat intake was not significant ( P=.09 ) . Higher vegetable fat intake had a stronger relationship with increased risk of AMD progression with an RR of 3.82 ( 95 % confidence interval , 1.58 - 9.28 ) for the highest quartile compared with the lowest quartile ( P trend = .003 ) . Saturated , monounsaturated , polyunsaturated , and transunsaturated fats increased the likelihood of progression ( RR , 2.09 and P trend = .08 ; RR , 2.21 and P trend = .04 ; RR , 2.28 and P trend = .04 ; RR , 2.39 and P trend = .008 , respectively ) . Higher fish intake was associated with a lower risk of AMD progression among subjects with lower linoleic acid intake . Processed baked goods , which are higher in some of these fats , increased the rate of AMD progression approximately 2-fold , and nuts were protective . CONCLUSIONS Among individuals with the early or intermediate stages of AMD , total and specific types of fat intake , as well as some fat-containing food groups , modified the risk of progression to advanced AMD . Fish intake and nuts reduced risk . Since advanced AMD is associated with visual loss and reduced quality of life , these preventive measures deserve additional research and greater emphasis Purpose To evaluate the dynamic remodeling of drusen in subjects with unilateral neovascular age-related macular degeneration ( AMD ) receiving a three-year course of oral docosahexaenoic acid ( DHA ) or placebo . Setting Institutional setting . Methods Three hundred subjects with age-related maculopathy and neovascular AMD in the fellow eye were r and omly assigned to receive either 840 mg/day DHA or placebo for 3 years . Main outcome measures of this post-hoc sub-group analysis were progression of drusen number , total diameter , and total area on fundus photography , and their association with DHA supplementation , socio-demographic and genetic characteristics . Results Drusen progression was analyzed in 167 subjects that did not develop CNV ( 87 that received DHA and 80 that received placebo ) . None of the drusen remodeling outcomes were significantly associated with DHA supplementation . Total drusen diameter reduction in the inner subfield was significantly associated with age ( older patients : r = -0.17 ; p = 0.003 ) . Women showed a tendency to decreased total drusen diameter in the inner subfield with CFH polymorphism ( p = 0.03 ) , where women with TT genotype tended to have a greater reduction in drusen diameter than other genotypes ( CC and CT ) . Drusen area in the inner subfield was more reduced in older patients ( r = -0.17 ) and in women ( p = 0.01 ) . Drusen number showed no significant trends . Conclusions Dynamic drusen remodeling with net reduction in drusen \n Output:\n " }, { "from": "agent", "value": "The results of this meta- analysis demonstrated that fish consumption can reduce AMD risk ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND AND PURPOSE The goal of the present study was to examine the re source and economic implication s of an early hospital discharge and home-based rehabilitation scheme for patients with acute stroke . METHODS A cost minimization analysis in conjunction with a r and omized controlled trial was carried out at 2 affiliated teaching hospitals in the southern metropolitan region of Adelaide , South Australia , between 1997 and 1998 . Eighty-six hospitalized patients with acute stroke who required rehabilitation were r and omized to receive both early hospital discharge and home-based rehabilitation , or conventional in-hospital rehabilitation and community care . Direct and indirect costs related to stroke rehabilitation were calculated , including hospital bed days , home-based intervention program , community services , and personal expenses during the 6 months after r and omization . RESULTS The mean cost per patient was lower for patients r and omized to the early hospital discharge and home-based rehabilitation ( $ 8040 ) compared with those who received conventional care ( $ 10 054 ) . This cost saving was not statistically significant ( P=0.14 ) . However , sensitivity analyses indicated that the cost of home-based rehabilitation was consistently lower than that of conventional care except when hospital costs were assumed to be 50 % less than those used in the main analysis . Multiple regression analysis demonstrated that the cost of the home-based program was significantly related to a patient 's level of disability after adjustment for age , comorbidity , and the presence or absence of a caregiver . CONCLUSIONS The early hospital discharge and home-based rehabilitation scheme was less costly than conventional hospital care for patients with stroke . Limitation of the provision of such services to patients with mild disability is likely to be most cost effective Background and Purpose — Early supported discharge ( ESD ) for stroke has been shown to yield outcomes similar to or better than those of conventional care , but there is less information on the impact on costs and on the caregiver . The purpose of this study is to estimate the costs associated with an ESD program compared with those of usual care . Methods — We conducted a r and omized controlled trial of stroke patients who required rehabilitation services and who had a caregiver at home . Results — Acute-care costs incurred before r and omization when patients were medically ready for discharge averaged $ 3251 per person . The costs for the balance of the acute-care stay , from r and omization to discharge , were $ 1383 for the home group and $ 2220 for the usual care group . The average cost of providing the 4-week home intervention service was $ 943 per person . The total cost generated by persons assigned to the home group averaged $ 7784 per person , significantly lower than the $ 11 065 per person for those assigned to usual care . A large proportion of the cost differential between the 2 groups arose from readmissions , for which the usual care group generated costs more than quadruple those of the home intervention group . Conclusions — Providing care at home was no more ( or less ) expensive for those with greater functional limitation than for those with less . Caregivers in the ESD group scored consistently lower on the Burden Index than caregivers with usual care , even caregivers of persons with major functional limitations . For persons recovering from stroke and their families , ESD provides a cost-effective alternative to usual care BACKGROUND AND PURPOSE In an inner-London teaching hospital , a r and omized trial of \" conventional \" care versus early discharge to community-based therapy found no significant differences in clinical outcomes between patient groups . This report examines the economic consequences of the alternative strategies . METHODS One hundred sixty-seven patients received the early discharge package , and 164 received conventional care . Patient utilization of health and social services was recorded over a 12-month period , and cost was determined using data from provider departments and other published sources . RESULTS Inpatient stay after r and omization was 12 days ( intervention group ) versus 18 days ( controls ) ( P=0.0001 ) . Average units of therapy per patient were as follows : physiotherapy , 22.4 ( early discharge ) versus 15.0 ( conventional ) ( P=0.0006 ) ; occupational therapy , 29.0 versus 23.8 ( P=0.002 ) ; speech therapy , 13 . 7 versus 5.8 ( P=0.0001 ) . The early discharge group had more annual hospital physician contacts ( P=0.015 ) and general practitioner clinic visits ( P=0.019 ) but fewer incidences of day hospital attendance ( P=0.04 ) . Other differences in utilization were nonsignificant . Average annual costs per patient were pound sterling 6800 ( early discharge ) and pound sterling 7432 ( conventional ) . The early discharge group had lower inpatient costs per patient ( pound sterling 4862 [ 71 % of total cost ] versus pound sterling 6343 [ 85 % ] for controls ) but higher non-inpatient costs ( pound sterling 1938 [ 29 % ] versus pound sterling 1089 [ 15 % ] ) . Further analysis demonstrated that early discharge is unlikely to lead to financial savings ; its main benefit is to release capacity for an expansion in stroke caseload . CONCLUSIONS Overall results of this trial indicate that early discharge to community rehabilitation for stroke is cost-effective . It may provide a means of addressing the predicted increase in need for stroke care within existing hospital capacity Background and Purpose The aim of the present study was to examine re source utilization during a 12-month period after acute stroke in elderly patients r and omized to care in an acute stroke unit integrated with a care continuum compared with conventional care in general medical wards . A secondary aim was to describe costs related to the severity of stroke . Methods Two hundred forty-nine consecutive patients aged ≥70 years with acute stroke within 7 days before admission , living in their own homes in Göteborg , Sweden , without recognized need of care were r and omized to 2 groups : 166 patients were assigned to nonintensive stroke unit care with a care continuum , and 83 patients were assigned to conventional care . There was no difference in mortality or the proportion of patients living at home after 1 year . Main outcomes were costs from inpatient care , outpatient care , and informal care . Results Mean annual cost per patient was 170 000 Swedish crowns ( SEK ) ( equivalent to $ 25 373 ) and 191 000 SEK ( $ 28 507 ) in the stroke unit and the general medical ward groups , respectively ( P = NS ) . Seventy percent of the total cost was for inpatient care , and 30 % was for outpatient and informal care . For patients with mild , moderate , and severe stroke , the mean annual costs per patient were 107 000 SEK ( $ 15 970 ) , 263 000 SEK ( $ 39 254 ) , and 220 000 SEK ( $ 32 836 ) , respectively ( P < 0.001 ) . There was no statistical difference in age or nonstroke diagnosis . Conclusions The total costs the first year did not differ significantly between the treatment groups in this prospect i ve study . The total annual cost per patient showed a very large variation , which was related to stroke severity at onset and not to age or nonstroke diagnoses . Costs other than those for hospital care constituted a substantial fraction of total costs and must be taken into account when organizing the management of stroke patients . The high variability in costs necessitates a larger study to assess long-term cost effectiveness Background and Purpose — Although stroke units reduce mortality and institutionalization , their comparative cost-effectiveness is unknown . Methods — Healthcare , social services , and informal care costs were compared for 447 acute stroke patients r and omly assigned to stroke unit , stroke team , or domiciliary stroke care . Prospect i ve and retrospective methods were used to identify re source use over 12 months after stroke onset . Cost-effectiveness and cost-utility analyses were undertaken . Results — Mean healthcare and social care costs over 12 months were £ 11 450 for stroke unit , £ 9527 for stroke team , and £ 6840 for domiciliary care . More than half the costs were for the initial episode of care . Institutionalization was a large proportion of follow-up costs . Inclusion of informal care increased costs considerably . When informal care was excluded , the incremental cost-effectiveness ratio per percentage point in deaths or institutionalizations avoided in the first year was £ 496 for the stroke unit over domiciliary care ; incremental cost per quality -adjusted life year quality -adjusted life year gained was £ 64 097 between these 2 groups . The stroke team was dominated by domiciliary care . Conclusions — Cost perspectives , especially those related to long-term and informal care , are important when stroke services are evaluated . Improved health outcomes in the stroke unit come at a higher cost Background and Purpose — Level I evidence from r and omized controlled trials demonstrates that the model of hospital care influences stroke outcomes ; however , the economic evaluation of such is limited . An economic appraisal of 3 acute stroke care models was facilitated through the Stroke Care Outcomes : Providing Effective Services ( SCOPES ) study in Melbourne , Australia . The aim was to describe re source use up to 28 weeks poststroke for each model and examine the cost-effectiveness of stroke care units ( SCUs ) . Methods — A prospect i ve , multicenter , cohort study design was used . Costs and outcomes of stroke patients receiving 100 % treatment in 1 of 3 inpatient care models ( SCUs , mobile service , conventional care ) were compared . Health-sector re source use up to 28 weeks was measured in 1999 . Outcomes were thorough adherence to a suite of important clinical processes and the number of severe inpatient complications . Results — The sample comprised 395 participants ( mean age 73 [ SD 14 ] , 77 % first-ever strokes , males 53 % ) . When compared with conventional care ( n=84 ) , costs for mobile service ( n=209 ) were significantly higher ( P=0.024 ) , but borderline for SCU ( n=102 , P=0.08 ; $ AUD12 251 ; $ AUD15 903 ; $ AUD15 383 respectively ) . This was primarily explained by the greater use of specialist medical services . The incremental cost-effectiveness of SCUs over conventional care was $ AUD9867 per patient achieving thorough adherence to clinical processes and $ AUD16 372 per patient with severe complications avoided , based on costs to 28 weeks . Conclusions — Although acute SCU costs are generally higher , they are more cost-effective than either mobile service or conventional care BACKGROUND AND PURPOSE Treatment of stroke patients in specialized stroke units has become more frequent , yet the effect of this treatment has not been determined . METHODS In a community-based , prospect i ve , and consecutive study of 1241 unselected acute stroke patients , we compared outcome of stroke treatment between two neighboring communities within Greater Copenhagen : the Bispebjerg community , where all acute stroke patients are treated and rehabilitated on a stroke unit , and Frederiksberg community , where all acute stroke patients are treated and rehabilitated on general neurological and medical wards . Except for the different organization of stroke treatment , the two communities and the two patient groups were comparable . Specifically , age , sex , marital status , prestroke residence , and stroke severity were not statistically different between patients treated on the stroke unit and those treated on the general neurological and medical wards . Multivariate regression analyses were used to estimate the independent influence of stroke unit treatment on outcome . RESULTS Stroke unit treatment significantly reduced in-hospital mortality ( odds ratio [ OR ] , 0.50 ; 95 % confidence interval [ CI ] , 0.34 to 0.74 ; P < .001 ) , case-fatality rate ( OR , 0.45 ; CI , 0.28 to 0.71 ; P < .001 ) , 6-month mortality ( OR , 0.57 ; CI , 0.39 to 0.82 ; P = .002 ) , 1-year mortality ( OR , 0.59 ; CI , 0.42 to 0.84 ; P = .003 ) , and discharge rate to a nursing home ( OR , 0.61 ; CI , 0.38 to 0.98 ; P = .04 ) . Discharge rate to the patient 's own home was significantly increased ( OR , 1.90 ; CI , 1.30 to 2.70 ; P < .001 ) . The length of hospital stay ( including rehabilitation ) was reduced significantly by 30 % in patients treated on the stroke unit despite their lower mortality ( P < .001 ) . The savings due to stroke unit treatment were estimated at 1313 bed-days and three places at a nursing home per 100 stroke patients . CONCLUSIONS Treatment of unselected acute stroke patients on a stroke care unit saved lives , reduced the length of hospital stay , reduced the frequency of discharge to a nursing home , and potentially reduced cost Background and Purpose Several trials have shown that stroke unit care improves outcome for stroke patients . The aim of the present trial was to evaluate the effects of an extended stroke unit service ( ESUS ) , with early supported discharge , cooperation with the primary healthcare system , and more emphasis on rehabilitation at home as essential elements . Methods In a r and omized , controlled trial , 160 patients with acute stroke were allocated to the ESUS and 160 to the ordinary stroke unit service ( OSUS ) . The primary outcome was the proportion of patients who were independent as assessed by the modified Rankin Scale ( RS ) ( RS ≤2=global independence ) and independent in activities of daily living ( ADL ) as assessed by Barthel Index ( BI ) ( BI ≥95=independent in ADL ) after 26 weeks . Secondary outcomes were RS and BI scores after 6 weeks ; the proportion of patients \n Output:\n " }, { "from": "agent", "value": "Home-based rehabilitation is unlikely to lead to cost-savings , but achieves better health outcomes .\nCare in stroke units is more expensive than conventional care , but leads to improved health outcomes .\nThe cost-effectiveness studies on integrated stroke services suggest that they can reduce costs ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: A prospect i ve r and omised trial was performed to evaluate the effectiveness of an asthma education programme administered by an asthma nurse specialist in an out-patient setting . Sixty asthmatic patients ( mean age 28.5 years ) were enrolled , 30 to a usual care control group and 30 to an education group . The education group underwent an individual education programme lasting at least one hour . The following variables were measured at baseline , one month after the education programme and at one year follow-up : asthma knowledge by MCQ ( 36 point question naire ) , inhaler technique ( 7 point scale ) , peak expiratory flow rate ( PEFR ) and symptomatology by visual analogue score ( 0 to 10 score ) . The education group 's inhaler technique and MCQ score both improved significantly at one month , from 5.4 ( 0.3 ) ( mean [ SEM ] ) to 6.5 ( 0.3 ) , p < 0.001 , and from 7.5 ( 2.4 ) to 22 ( 1.8 ) , p < 0.0001 respectively . Both of these improvements were significantly greater than in the control group , and both were maintained at one year follow-up . The symptom score improved over one year in the education group , from 5.4 ( 0.6 ) to 7.6 ( 0.5 ) , p < 0.05 , and was unchanged in the control group . There was no change in the PEFR in either group . This study shows clear objective benefits to an out-patient asthma education programme conducted by an asthma nurse specialist Self-report is a frequently-used method of assessing compliance with prescribed medications in patients with chronic illnesses . Most research ers agree , however , that self-report misrepresents patient adherence to regimen prescription . In this r and omized , controlled study evaluating inhaler medication compliance , diary data was compared to electronic monitoring in 55 adults with asthma . Subjects r and omized to the treatment group received a six-week self-management program . An electronic monitor , the MDI Chronolog , was used in this study to assess inhaler use . The MDI Chronolog records the date and time of each inhaled activation . The self-report measure used was a daily asthma diary . Subjects were asked to use their inhaled medications as usual and record the date and time they administered their medication over a one-week period . Moderate correlations ( rs=.55 , Mdnd=95.8 , Mdnc=91.6 ) were found when comparing the number of administrations calculated using the MDI Chronolog to the number of administrations reported in the subject ’s diary . When the dosing interval was examined , however , the correlation was weaker ( rs=.44 , Mdndiary=92.8 , Mdnchronolog=37.5 ) . In each case , self-reported compliance was higher than monitored adherence A prospect i ve controlled trial of home monitoring of peak expiratory flow rate ( PEFR ) was conducted to determine the usefulness of an objective measure of lung function in association with an education program and a medication self-management plan in reducing morbidity in adult patients with asthma . Thirty-five patients managed themselves , using peak flow readings as the basis for the therapeutic plan coupled with educational intervention , whereas 35 control patients used symptoms and spirometric data for following physicians ' treatment plans . After a 6-mo study period , patients in the experimental group showed statistically significant improvements in morbidity parameters ( days lost from work , acute asthma attacks , days on antibiotic therapy , physician consultations , and emergency room admissions for asthma ) , increases in FVC , FEV1 , and FEV1/FVC , mean PEFR and mean morning PEFR , decrease in percentage of the mean PEFR amplitude , and a reduction in the use of inhaled beta-agonists , oral theophylline , and oral prednisone . Although improvements in some of these parameters were also found in the control group , they did not reach the levels of significance obtained in the experimental group . The personal use of an objective measure of lung function in association with a medication self-management plan leads to improvement in the patient 's condition BACKGROUND --A hospital based , community service asthma education programme for adults to improve asthma knowledge , promote compliance with medication , and reduce morbidity was evaluated . METHODS --The programme was evaluated using a r and omised experimental and control group design with repeated measurements over 12 months . A volunteer community sample of 192 respondents was recruited of whom 116 satisfied the inclusion criteria . At the 12 month follow up some data were obtained for all subjects . Intervention subjects attended four 2.5 hour education sessions at weekly intervals . An asthma knowledge question naire was administered and compliance was assessed from diary records . Morbidity was assessed retrospectively by question naire , prospect ively by diary , and objective ly by spirometry and serial peak expiratory flow rate monitoring . The adequacy of medical treatment was also assessed . Data were collected at baseline , immediately after the intervention , and at three , six , nine , and 12 months after intervention . RESULTS --Improvements occurred in knowledge and compliance in the intervention group but the impact on morbidity was modest ; this was due , at least in part , to the inadequacy of medical treatment . CONCLUSIONS --Treatment of asthma should be review ed and optimised in conjunction with self-management programmes in order to improve health outcomes Abstract Objectives To assess the feasibility and effectiveness of a general practice based , proactive system of asthma care in children . Design R and omised controlled trial with cluster sampling by general practice . Setting General practice s in the northern region of the Australian Capital Territory . Participants 174 children with moderate to severe asthma who attended 24 general practitioners . Intervention System of structured asthma care ( the 3 + visit plan ) , with participating families reminded to attend the general practitioner . Main outcome measures Process measures : rates for asthma consultations with general practitioner , written asthma plans , completion of the 3 + visit plan ; clinical measures : rates for emergency department visits for asthma , days absent from school , symptom-free days , symptoms over the past year , activity limitation over the past year , and asthma drug use over the past year ; spirometric lung function measures before and after cold air challenge . Results Intervention group children had significantly more asthma related consultations ( odds ratio for three or more asthma related consultations 3.8 ( 95 % confidence interval 1.9 to 7.6 ; P = 0.0001 ) , written asthma plans ( 2.2 ( 1.2 to 4.1 ) ; P = 0.01 ) , and completed 3 + visit plans ( 24.2 ( 5.7 to 103.2 ) ; P = 0.0001 ) than control children and a mean reduction in measurements of forced expiratory volume in one second after cold air challenge of 2.6 % ( 1.7 to 3.5 ) ; P = 0.0001 ) less than control children . The number needed to treat ( benefit ) for one additional written asthma action plan was 5 ( 3 to 41 ) children . Intervention group children had lower emergency department attendance rates for asthma ( odds ratio 0.4 ( 0.2 to 1.04 ) ; P = 0.06 ) and less speech limiting wheeze ( 0.2 ( 0.1 to 0.4 ) ; P = 0.0001 ) than control children and were more likely to use a spacer ( 2.8 ( 1.6 to 4.7 ) ; P = 0.0001 ) . No differences occurred in number of days absent from school or symptom-free day scores . Conclusions Proactive care with active recall for children with moderate to severe asthma is feasible in general practice and seems to be beneficial To assess the efficacy of self-management programs it is important to know what behavioural changes take place . This paper assesses whether including self-treatment guidelines ( action plans ) in a self-management program for adult asthmatics , leads to greater behavioural changes than a program without these guidelines . Patients were r and omised into a self-treatment group ( n=123 ) or an active control group ( n=122 ) . All subjects received self-management training . Discussed topics included the pathophysiology of asthma , medication and side-effects , triggers , symptoms , smoking , physical exercise , and compliance . The only difference was that the self-treatment group received instructions about self-treatment of exacerbations and the control group did not . At 1 year of follow-up asthma-specific self-efficacy expectancies , outcome expectancies , and asthma-specific knowledge improved significantly in all patients . Only self-treatment group patients demonstrated favourable changes in generalised self-efficacy , social support , and self-treatment and self-management behaviour , in case of a hypothetical scenario of a slow-onset exacerbation . We conclude that our self-management program is effective in changing the behavioural variables , and including self-treatment guidelines ( action plans ) has added benefit Great emphasis is placed on educating asthmatics to use action plans to achieve better control of symptoms . The use of peak flow meters ( PFM ) has been recommended as an important part of self-management plans . We studied 92 ( 47 F ) adult patients with asthma in a primary care setting to compare the effectiveness of action plans using either peak flow monitoring or symptoms to guide self-management . Each patient was instructed in the use of the action plan in the context of a 6-mo asthma education program taught by a nurse . Patients were already using inhaled corticosteroids or were newly prescribed corticosteroids by their family physician . Forty-four patients were r and omized to the PFM group and 48 to the symptoms group . Spirometry , symptom scores , quality of life , medication use , and measures of health care utilization and morbidity ( emergency department visits , hospitalizations , unscheduled doctor visits , and days lost from work or school ) were recorded at baseline and throughout the study period . PC20 methacholine was measured at the first and at the final visits . There were significant improvements within groups for FEV1 , symptoms score , PC20 methacholine , and quality of life , but no between-group differences . A significant shift from higher to lower daily use of beta-agonists ( p < 0.008 for both groups ) and significant shifts to higher daily doses of inhaled steroids ( p < 0.001 ) occurred in each group . Adherence to the self-management plans was only 65 % in the PFM group and 52 % in the symptoms group . Outcomes for health care utilization were similar except for fewer patients making unscheduled doctor visits within the PFM group . Our findings show that education , regular follow-up , and an action plan are effective in improving asthma control and quality of life , but the routine use of PFM to guide interventions is not the only way to accomplish these objectives The purpose of the AIR/Kaiser-Permanente asthma project is to evaluate various approaches to the education of adults with asthma , identifying those types of patients for whom particular approaches are most cost effective . Critical self-management prac tices for adults with asthma were identified using the critical incident technique . An individualized and a group administered educational program are being developed to teach the identified critical skills , using the instructional models previously employed in AIR WISE and AIR POWER programs for children with asthma . Three hundred patients with moderate to severe asthma from Northern California Kaiser-Permanente Medical Group clinics will participate in a trial of these programs . Patients will be r and omly assigned to one of four conditions : One of two educational programs , an information/attention control , or a data -only control condition . Data will be collected on all patients for 15 months ; health care utilization data covering a two-year period will be available from medical records . Program effectiveness will be evaluated in terms of pre-post changes in the patients ' knowledge , attitudes , self-man agement practice s , medical condition , daily functioning , and utilization of services . Cost effectiveness will be evaluated , paying specific attention to the cost effectiveness of different educational approaches for different types of patients Two different patient education programmes for asthma in general practice were evaluated in a controlled trial . Knowledge , self management , and morbidity due to asthma were assessed in 339 patients by means of a question naire . One group then received a maximum education programme , a second group received a limited education programme , and a third acted as a control group . 274 patients were reassessed after one 1 year . In both the intervention groups , underst and ing of asthma was greater after the trial . Only in the maximum intervention group was a significant improvement in knowledge of asthma shown . Neither group showed any change in self-management ability or asthma morbidity that differed significantly from changes in the control group . These simple informational education programmes were ineffective when applied to a general practice population . Further studies of factors affecting attitudes , beliefs , and actions are needed to improve the advice and support given to asthma patients The purpose of this study was to evaluate the impact of a self-management program for adults with moderate to severe asthma on compliance with inhaled , prescribed , nonemergency medications ; asthma symptoms ; and airway obstruction . In this controlled experimental study , 55 subjects from a rural community were r and omized to one of two groups . Self-efficacy theory served as the framework for this study . Primary measures included the Metered Dose Inhaler ( MDI ) Chronolog , a journal of daily asthma concerns , and a peak-flow meter to appraise airway obstruction . Secondary measures included the Asthma Self-Management Assessment Tool ( ASMAT ) and the Self-Efficacy for Asthma Management Scale ( SEAMS ) . These measures were completed pre- and post-intervention . Data analysis using descriptive and inferential statistics revealed that subjects receiving the self-management program increased compliance with inhaled medications ( U = 271 , p = .043 ) Our aim was to assess the efficacy of budesonide ( Pulmicort Turbohaler Astra ) used as part of a self-management plan in a group of patients with chronic asthma . One hundred and twenty five patients with nocturnal ast \n Output:\n " }, { "from": "agent", "value": "There was no consistent evidence that written plans produced better patient outcomes than no written plan .\nFor some outcomes , there appeared to be an advantage of one type of plan over the other , but there was no consistency - one type of plan was not consistently more effective than another .\nREVIEW ERS ' CONCLUSIONS The available trials are too small and the results too few and inconsistent to form any firm conclusions as to the contribution of written self management plans in the known beneficial effects of a comprehensive asthma care programme" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The efficacy of cephalothin sodium , added to dialysis fluids , as prophylaxis against infection during peritoneal dialysis was tested in a r and om double-blind study of 95 dialyses performed in 36 patients . Although the two cases of clinical peritonitis observed occurred in the placebo group , this observation was not statistically significant . The number of positive cultures obtained from the dialysate returns , however , was significantly greater in the placebo group . The duration of the dialysis did not correlate with the finding of bacteria in the dialysate returns or with the development of clinical peritonitis Infection is the Achilles heel of peritoneal dialysis . Exit site mupirocin prevents Staphylococcus aureus peritoneal dialysis ( PD ) infections but does not reduce Pseudomonas aeruginosa or other Gram-negative infections , which are associated with considerable morbidity and sometimes death . Patients from three centers ( 53 % incident to PD and 47 % prevalent ) were r and omized in a double-blinded manner to daily mupirocin or gentamicin cream to the catheter exit site . Infections were tracked prospect ively by organism and expressed as episodes per dialysis-year at risk . A total of 133 patients were r and omized , 67 to gentamicin and 66 to mupirocin cream . Catheter infection rates were 0.23/yr with gentamicin cream versus 0.54/yr with mupirocin ( P = 0.005 ) . Time to first catheter infection was longer using gentamicin ( P = 0.03 ) . There were no P. aeruginosa catheter infections using gentamicin compared with 0.11/yr using mupirocin ( P < 0.003 ) . S. aureus exit site infections were infrequent in both groups ( 0.06 and 0.08/yr ; P = 0.44 ) . Peritonitis rates were 0.34/yr versus 0.52/yr ( P = 0.03 ) , with a striking decrease in Gram-negative peritonitis ( 0.02/yr versus 0.15/yr ; P = 0.003 ) using gentamicin compared with mupirocin cream , respectively . Gentamicin use was a significant predictor of lower peritonitis rates ( relative risk , 0.52 ; 95 % confidence interval , 0.29 to 0.93 ; P < 0.03 ) , controlling for center and incident versus prevalent patients . Gentamicin cream applied daily to the peritoneal catheter exit site reduced P. aeruginosa and other Gram-negative catheter infections and reduced peritonitis by 35 % , particularly Gram-negative organisms . Gentamicin cream was as effective as mupirocin in preventing S. aureus infections . Daily gentamicin cream at the exit site should be the prophylaxis of choice for PD patients We have studied the efficacy of topical Mupirocin for elimination of Staphylococcus aureus ( Staph . aureus ) nasal carriage in CAPD patients . Staph . aureus nasal carriers in our CAPD program were r and omized to one of two groups : Group 1 , treated with Mupirocin , and Group 2 , treated with neomycin sulphate nasal ointment . The prevalence of Staph . aureus nasal colonization was 44 % for patients ( 24/54 ) and 17 % for dialysis partners ( 5/29 ) . Group 1 included 11 patients and 1 partner , and Group 2 , 8 patients and 2 partners . In Group 1 , the eradication rate was 100 % , and the recolonization rate was 0 , 8 , 41 , 55 and 66 % at 1 , 2 , 3 , 6 and 10 months . In Group 2 , the eradication rate was 40 % , with a recolonization rate of 0.25 and 75 % at 1 , 2 and 3 months . Re-treatment with mupirocin was successful in 66 % of the cases , compared to 20 % for neomycin . The MIC90 of mupirocin for Staph . aureus was 0.5 mcg/mL , with an increase to 4 mcg/mL towards the end of the study . During the study period , there was a very low incidence of Staph . aureus peritonitis or catheter-related infections in patients treated with mupirocin . Secondary effects of mupirocin were negligible . Mupirocin is more effective than neomycin sulphate for the elimination of Staph . aureus nasal colonization in patients undergoing CAPD . Periodic re-treatment is frequently necessary , given the significant recolonization rate This study evaluates the dialysis-related infection rate in children receiving peritoneal dialysis with Staphylococcus aureus nasal carriage . Children with S. aureus nasal carriage were r and omized to treatment with rifampin and bacitracin or no treatment . The children were observed for one month after r and omization for evidence of a S. aureus dialysis-related infection . Individuals with nasal carriage had a higher incidence of S. aureus dialysis-related infection than those patients without carriage ( p < 0.05 ) . Those children treated for nasal carriage had a lower dialysis-related infection rate than those who were untreated ( p < 0.05 ) . We conclude that children receiving peritoneal dialysis with nasal carriage of S. aureus are at a greater risk of developing a S. aureus dialysis-related infection . The treatment of nasal carriage in this population decreased the risk of a S. aureus dialysis-related infection ♦ Background : The HONEYPOT study is a multicenter , open-label , blinded- outcome , r and omized controlled trial design ed to determine whether , compared with st and ard topical application of mupirocin for nasal staphylococcal carriage , exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients . ♦ Objective : To make public the pre-specified statistical analysis principles to be adhered to and the procedures to be performed by statisticians who will analyze the data for the HONEYPOT trial . ♦ Methods : Statisticians and clinical investigators who were blinded to treatment allocation and treatment-related study results and who will remain blinded until the central data base is locked for final data extraction and analysis determined the statistical methods and procedures to be used for analysis and wrote the statistical analysis plan . The plan describes basic analysis principles , methods for dealing with a range of commonly encountered data analysis issues , and the specific statistical procedures for analyzing the primary , secondary , and safety outcomes . ♦ Results : A statistical analysis plan containing the pre-specified principles , methods , and procedures to be adhered to in the analysis of the data from the HONEYPOT trial was developed in accordance with international guidelines . The structure and content of the plan provide sufficient detail to meet the guidelines on statistical principles for clinical trials produced by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use . ♦ Conclusions : Making public the pre-specified statistical analysis plan for the HONEYPOT trial minimizes the potential for bias in the analysis of trial data and the interpretation and reporting of trial results Exit site infection is a major risk factor for the development of peritonitis in continuous ambulatory peritoneal dialysis . The frequency of infection can be reduced by scrupulous exit site care with or without topical antiseptics . A r and omized trial was performed of 149 catheters in 130 patients to assess any additional benefits conferred by the use of povidine iodine dry powder spray at dressing changes over an existing strict protocol of exit care . Exit infections occurred in 14 ( 18 % ) of 77 patients using spray and in 15 ( 21 % ) of 72 patients not using spray . The risk of peritonitis was also similar in each group . The proportion of infections caused by Staphylococcus aureus was reduced in the spray group , but those caused by Pseudomonas aeruginosa were increased . Rash occurred in 6 % of those using the spray . The use of the spray did not therefore seem justified Over a three-year period , 217 episodes of bacterial peritonitis occurred in 183 patient years . Thirty-seven episodes were due to Staphylococcus aureus and 19 ( 51 % ) of these required removal of the catheter to eradicate infection . This compared with catheter loss in 4/63 ( 6.3 % ) coagulase negative staphylococci infections ( p < 0.001 ) ; 7/67 ( 9.5 % ) culture negative peritonitis ( p < 0.001 ) ; and 10/30 ( 33.3 % ) episodes due to gram-negative organisms ( p < 0.05 ) . Over half ( 51.3 % ) the episodes due to S. aureus were associated with exit-site infections , and this rose to 100 % ( 10/10 ) with recurrent peritonitis ( p < 0.01 ) . A prospect i ve analysis of nasal carriage and exit-site infections due to S. aureus was carried out in 87 patients . Exit-site infections were present in 21 ( 24 % ) , almost entirely due to different strains as judged by sensitivity patterns and phage typing . Nasal carriage , defined as two positive swabs within the study period , was present in 20 ( 23 % ) patients . Fourteen ( 70 % ) of these had exit site infections due to the same strain as that isolated from the nose , whereas no patient grew different strains from either site . Nasal carriage increased the risk of infection sixfold ( p < 0.001 ) Background The use of peritoneal dialysis ( PD ) has declined in the United States over the past decade and technique failure is also reportedly higher in PD compared to hemodialysis ( HD ) , but there are little data in the United States addressing the factors and outcomes associated with switching modalities from PD to HD . Methods In a prospect i ve cohort study of 262 PD patients enrolled from 28 peritoneal dialysis clinics in 13 U.S. states , we examined potential predictors of switching from PD to HD ( including demographics , clinical factors , and laboratory values ) and the association of switching with mortality . Cox proportional hazards regression was used to assess relative hazards ( RH ) of switching and of mortality in PD patients who switched to HD . Results Among 262 PD patients , 24.8 % switched to HD ; with more than 70 % switching within the first 2 years . Infectious peritonitis was the leading cause of switching . Patients of black race and with higher body mass index were significantly more likely to switch from PD to HD , RH ( 95 % CI ) of 5.01 ( 1.15–21.8 ) for black versus white and 1.09 ( 1.03–1.16 ) per 1 kg/m2 increase in BMI , respectively . There was no difference in survival between switchers and non-switchers , RH ( 95 % CI ) of 0.89 ( 0.41–1.93 ) . ConclusionS witching from PD to HD occurs early and the rate is high , threatening long-term viability of PD programs . Several patient characteristics were associated with the risk of switching . However , there was no survival difference between switchers and non-switchers , reassuring providers and patients that PD technique failure is not necessarily associated with poor prognosis ♦ Background : One of the most common and severe complications affecting peritoneal dialysis ( PD ) patients is exit-site infection of the peritoneal catheter ; it is therefore of vital importance to prevent it . This complication has a negative impact on the success of the technique . In spite of this , there are no clear guidelines concerning how to take care of the exit site . The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period . ♦ Methods : We design ed a single-center , prospect i ve , open-labeled , r and omized controlled clinical trial with parallel groups . Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study . Patients were r and omized to be daily cured as follows : Group A : traditional care with saline serum and povidone-iodine ; and Group B : polyhexanide solution . Exit sites were evaluated at baseline and every four to six weeks or if any event occurred , according to the Twardowski criteria . ♦ Results : Of the 60 included patients , 46 completed the 12-month follow-up period . Six underwent transplantation , five died and three were transferred to hemodialysis ( HD ) . The treatment was well tolerated , with no side effects nor ab and onments due to such effects . Throughout the study period , six patients ( 20 % ) undergoing traditional care and only two ( 6,7 % ) receiving polyhexanide developed an exit-site infection ( p = 0.032 ) . There were a total number of 12 infections ; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide ( p = 0.037 ) . The germs responsible for the infections were : S. aureus ( six cases ) , Corynebacterium jeikeium ( two cases ) and P. aeruginosa ( one case ) in the saline serum and povidone-iodine group and P. aeruginosa ( three cases ) in the polyhexanide group . The mean rate of exit-site infection was 1 episode/36. \n Output:\n " }, { "from": "agent", "value": "This review demonstrates that pre/peri-operative intravenous vancomycin may reduce the risk of early peritonitis and that antifungal prophylaxis with oral nystatin or fluconazole reduces the risk of fungal peritonitis following an antibiotic course .\nHowever , no other antimicrobial interventions have proven efficacy .\nIn particular , the use of nasal antibiotic to eradicate Staphylococcus aureus , had an uncertain effect on the risk of peritonitis and raises questions about the usefulness of this approach ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To investigate the effect of ice slurry ingestion on thermoregulatory responses and submaximal running time in the heat . METHODS On two separate occasions , in a counterbalanced order , 10 males ingested 7.5 g·kg(-1 ) of either ice slurry ( -1 ° C ) or cold water ( 4 ° C ) before running to exhaustion at their first ventilatory threshold in a hot environment ( 34.0 ° C ± 0.2 ° C , 54.9 % ± 5.9 % relative humidity ) . Rectal and skin temperatures , HR , sweating rate , and ratings of thermal sensation and perceived exertion were measured . RESULTS Running time was longer ( P = 0.001 ) after ice slurry ( 50.2 ± 8.5 min ) versus cold water ( 40.7 ± 7.2 min ) ingestion . Before running , rectal temperature dropped 0.66 ° C ± 0.14 ° C after ice slurry ingestion compared with 0.25 ° C ± 0.09 ° C ( P = 0.001 ) with cold water and remained lower for the first 30 min of exercise . At exhaustion , however , rectal temperature was higher ( P = 0.001 ) with ice slurry ( 39.36 ° C ± 0.41 ° C ) versus cold water ingestion ( 39.05 ° C ± 0.37 ° C ) . During exercise , mean skin temperature was similar between conditions ( P = 0.992 ) , as was HR ( P = 0.122 ) and sweat rate ( P = 0.242 ) . After ice slurry ingestion , subjects stored more heat during exercise ( 100.10 ± 25.00 vs 78.93 ± 20.52 W·m(-2 ) , P = 0.005 ) , and mean ratings of thermal sensation ( P = 0.001 ) and perceived exertion ( P = 0.022 ) were lower . CONCLUSIONS Compared with cold water , ice slurry ingestion lowered preexercise rectal temperature , increased submaximal endurance running time in the heat ( + 19 % ± 6 % ) , and allowed rectal temperature to become higher at exhaustion . As such , ice slurry ingestion may be an effective and practical precooling maneuver for athletes competing in hot environments The present study tested the hypothesis that perceived exertion during prolonged exercise in hot environments is associated with changes in cerebral electrical activity rather than changes in the electromyogram ( EMG ) of the exercising muscles . Therefore , electroencephalogram ( EEG ) in three positions ( frontal , central , and occipital cortex ) , EMG , rating of perceived exertion ( RPE ) , and core temperature were measured in 14 subjects during submaximal exercise in normal ( 18 degrees C , control ) and hot ( 40 degrees C , hyperthermia ) environments . RPE increased from 11 + /- 1 units at 5 min to 20 + /- 0 units at exhaustion ( 50 + /- 3 min ) in the trial with progressive hyperthermia , whereas exercise in the control trial was maintained with a stable core temperature for 1 h without exhausting the subjects . Altered EEG activity was observed in all electrode positions , and stepwise forward-regression analysis identified core temperature and a frequency index of the EEG over the frontal cortex as the best predictors of RPE . In contrast , there were no significant correlations between RPE and any of the measured EMG parameters ( median spectral frequency , root mean square , or amplitude ) , and the EMG parameters were not different in hyperthermia compared with control . Thus hyperthermia does not seem to affect the activation pattern of the muscles . Rather , the linear correlation among core temperature , EEG frequency index , and RPE indicates that alterations in cerebral activity may be associated with the hyperthermia-induced development of fatigue during prolonged exercise in hot environments PURPOSE To develop and investigate the efficacy of a new precooling strategy combining external and internal techniques on the performance of a cycling time trial ( TT ) in a hot and humid environment . METHODS Eleven well-trained male cyclists undertook three trials of a laboratory-based cycling TT simulating the course characteristics of the Beijing Olympic Games event in a controlled hot and humid environment ( 32 ° C-35 ° C at 50%-60 % relative humidity ) . The trials , separated by 3 - 7 d , were undertaken in a r and omized crossover design and consisted of the following : 1 ) CON-no treatment apart from the ad libitum consumption of cold water ( 4 ° C ) , 2 ) STD COOL-whole-body immersion in cold ( 10 ° C ) water for 10 min followed by wearing a cooling jacket , or 3 ) NEW COOL-combination of consumption of 14 g of ice slurry ( \" slushie \" ) per kilogram body mass made from a commercial sports drink while applying iced towels . RESULTS There was an observable effect on rectal temperature ( T(rec ) ) before the commencement of the TT after both precooling techniques ( STD COOL < NEW COOL < CON , P < 0.05 ) , but pacing of the TT result ed in similar T(rec ) , HR , and RPE throughout the cycling protocol in all trials . NEW COOL was associated with a 3.0 % increase in power ( approximately 8 W ) and a 1.3 % improvement in performance time ( approximately 1:06 min ) compared with the CON trial , with the true likely effects ranging from a trivial to a large benefit . The effect of the STD COOL trial compared with the CON trial was \" unclear . \" CONCLUSIONS This new precooling strategy represents a practical and effective technique that could be used by athletes in preparation for endurance events undertaken in hot and humid conditions This study examined the independent and combined importance of aerobic fitness and body fatness on physiological tolerance and exercise time during weight-bearing exercise while wearing a semipermeable protective ensemble . Twenty-four men and women were matched for aerobic fitness and body fatness in one of four groups ( 4 men and 2 women in each group ) . Aerobic fitness was expressed per kilogram of lean body mass ( LBM ) to eliminate the influence of body fatness on the expression of fitness . Subjects were defined as trained ( T ; regularly active with a peak aerobic power of 65 ml x kg LBM(-1 ) x min(-1 ) ) or untrained ( UT ; sedentary with a peak aerobic power of 53 ml x kg LBM(-1 ) x min(-1 ) ) with high ( High ; 20 % ) or low ( Low ; 11 % ) body fatness . Subjects exercised until exhaustion or until rectal temperature reached 39.5 degrees C or heart rate reached 95 % of maximum . Exercise times were significantly greater in T(Low ) ( 116 + /- 6.5 min ) compared with their matched sedentary ( UT(Low ) ; 70 + /- 3.6 min ) or fatness ( T(High ) ; 82 + /- 3.9 min ) counterparts , indicating an advantage for both a high aerobic fitness and low body fatness . However , similar effects were not evident between T(High ) and UT(High ) ( 74 + /- 4.1 min ) or between the UT groups ( UT(Low ) and UT(High ) ) . The major advantage attributed to a higher aerobic fitness was the ability to tolerate a higher core temperature at exhaustion ( the difference being as great as 0.9 degrees C ) , whereas both body fatness and rate of heat storage affected the exercise time as independent factors We investigated whether fatigue during prolonged exercise in uncompensable hot environments occurred at the same critical level of hyperthermia when the initial value and the rate of increase in body temperature are altered . To examine the effect of initial body temperature [ esophageal temperature ( Tes ) = 35.9 + /- 0.2 , 37.4 + /- 0 . 1 , or 38.2 + /- 0.1 ( SE ) degrees C induced by 30 min of water immersion ] , seven cyclists ( maximal O2 uptake = 5.1 + /- 0.1 l/min ) performed three r and omly assigned bouts of cycle ergometer exercise ( 60 % maximal O2 uptake ) in the heat ( 40 degrees C ) until volitional exhaustion . To determine the influence of rate of heat storage ( 0.10 vs. 0.05 degrees C/min induced by a water-perfused jacket ) , four cyclists performed two additional exercise bouts , starting with Tes of 37.0 degrees C. Despite different initial temperatures , all subjects fatigued at an identical level of hyperthermia ( Tes = 40 . 1 - 40.2 degrees C , muscle temperature = 40.7 - 40.9 degrees C , skin temperature = 37.0 - 37.2 degrees C ) and cardiovascular strain ( heart rate = 196 - 198 beats/min , cardiac output = 19.9 - 20.8 l/min ) . Time to exhaustion was inversely related to the initial body temperature : 63 + /- 3 , 46 + /- 3 , and 28 + /- 2 min with initial Tes of approximately 36 , 37 , and 38 degrees C , respectively ( all P < 0.05 ) . Similarly , with different rates of heat storage , all subjects reached exhaustion at similar Tes and muscle temperature ( 40.1 - 40.3 and 40 . 7 - 40.9 degrees C , respectively ) , but with significantly different skin temperature ( 38.4 + /- 0.4 vs. 35.6 + /- 0.2 degrees C during high vs. low rate of heat storage , respectively , P < 0.05 ) . Time to exhaustion was significantly shorter at the high than at the lower rate of heat storage ( 31 + /- 4 vs. 56 + /- 11 min , respectively , P < 0.05 ) . Increases in heart rate and reductions in stroke volume paralleled the rise in core temperature ( 36 - 40 degrees C ) , with skin blood flow plateauing at Tes of approximately 38 degrees C. These results demonstrate that high internal body temperature per se causes fatigue in trained subjects during prolonged exercise in uncompensable hot environments . Furthermore , time to exhaustion in hot environments is inversely related to the initial temperature and directly related to the rate of heat storage The purpose of this study was to examine the effect of environmental temperature on variability in power output , self-selected pacing strategies , and performance during a prolonged cycling time trial . Nine trained male cyclists r and omly completed four 40 km cycling time trials in an environmental chamber at 17 ° C , 22 ° C , 27 ° C , and 32 ° C ( 40 % RH ) . During the time trials , heart rate , core body temperature , and power output were recorded . The variability in power output was assessed with the use of exposure variation analysis . Mean 40 km power output was significantly lower during 32 ° C ( 309 ± 35 W ) compared with 17 ° C ( 329 ± 31 W ) , 22 ° C ( 324 ± 34 W ) , and 27 ° C ( 322 ± 32 W ) . In addition , greater variability in power production was observed at 32 ° C compared with 17 ° C , as evidence d by a lower ( P = .03 ) st and ard deviation of the exposure variation matrix ( 2.9 ± 0.5 vs 3.5 ± 0.4 units , respectively ) . Core temperature was greater ( P < .05 ) at 32 ° C compared with 17 ° C and 22 ° C from 30 to 40 km , and the rate of rise in core temperature throughout the 40 km time trial was greater ( P < .05 ) at 32 ° C ( 0.06 ± 0.04 ° C·km-1 ) compared with 17 ° C ( 0.05 ± 0.05 ° C·km-1 ) . This study showed that time-trial performance is reduced under hot environmental conditions , and is associated with a shift in the composition of power output . These finding provide insight into the control of pacing strategies during exercise in the heat QUESTIONS Does the PEDro scale measure only one construct ie , the method ological quality of clinical trials ? What is the hierarchy of items of the PEDro scale from least to most adhered to ? Is there any effect of year of publication of trials on item adherence ? Are PEDro scale ordinal scores equivalent to interval data ? DESIGN Rasch analysis of two independent sample s of 100 clinical trials from the PEDro data base scored using the PEDro scale . RESULTS Both sample s of PEDro data showed fit to the Rasch model with no item misfit . The PEDro scale item hierarchy was the same in both sample s , ranging from the most adhered to item r and om allocation , to the least adhered to item therapist blinding . There was no differential item functioning by year of publication . Original PEDro ordinal scores were highly correlated with transformed PEDro interval scores ( r = 0.99 ) . CONCLUSION The PEDro scale is a valid measure of the method ological quality of clinical trials . It is valid to sum PEDro scale item scores to obtain a total score that can be treated as interval level measurement and subjected to parametric statistical analysis Abstract In this study we examined the influence of menstrual cycle phase and oral contraceptive use on thermoregulation and tolerance during uncompensable heat stress . Eighteen women ( 18–35 years ) , who differed only with respect to oral contraceptive use ( n = 9 ) or non-use ( n = 9 ) , performed light intermittent exercise at 40 ° C and 30 % relative humidity while wearing nuclear , biological and chemical protective clothing . Their responses were compared during the early fol \n Output:\n " }, { "from": "agent", "value": "Effect size calculations indicated moderate evidence that cold water immersion effectively improved endurance performance , and limited evidence that ice slurry ingestion improved performance .\nCooling garments were ineffective .\nConclusions Current evidence indicates cold water immersion may be the most effective method of pre-cooling to improve endurance performance in hot conditions , although practicality must be considered .\nIce slurry ingestion appears to be the most promising practical alternative .\nInterestingly , cooling garments appear of limited efficacy , despite their frequent use ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background : Exergames ( i.e. , video games that require gross motor activity ) may provide intrinsically motivating experiences that engage youth in sustained physical activity . Method : Thirty-one low-income 15– to 19-year-old overweight and obese African American adolescents were r and omly assigned to a competitive exergame ( n = 17 ) or a cooperative exergame ( n = 14 ) condition . Participants played a preassigned Wii Active exergame routine that took between 30 and 60 min each school day , and sessions occurred during lunch time or an after-school program over a 6 month period . Participation was voluntary , so students decided whether to come or not on a given day . Cooperative exergame players worked together with a peer to expend calories and earn points , while competitive exergame players competed individually against a peer to expend calories and earn points . Motivation was measured through surveys and interviews at the end of the intervention , and energy expenditure was measured by accelerometry during game play . Results : Compared with the competitive group , the cooperative players were significantly more intrinsically motivated to play ( p = .034 , partial eta-squared = 0.366 ) and more psychologically attracted to the design of the exergame ( p = .034 , partial eta-squared = 0.320 ) . Intrinsic motivation was significantly positively correlated with energy expenditure during game play : Individuals who were motivated by control/choice had higher energy expenditure ( p = .026 ) , and those who were more goal motivated ( p = .004 ) and more immersed in game play ( p = .024 ) had lower energy expenditure during game play . Conclusions : Cooperative exergame play produced higher intrinsic motivation to play the exergame than competitive exergame play did . Intrinsic motivation that came from a desire for control/choice was related to higher energy expenditure during game play . Cooperative exergame play holds promise as a method for engaging overweight and obese youth in physical activity Process evaluation is valuable in guiding development of effective intervention programmes but rare in adolescent weight management . This paper presents a process evaluation of the Loozit ( ® ) r and omized controlled trial , a community-based behavioural lifestyle intervention for obese 13 - 16 year olds . Adolescents were r and omized to receive the two-phase Loozit ( ® ) group programme , with ( n = 73 ) or without ( n = 78 ) , additional therapeutic contact ( telephone coaching , short message service and /or emails ) in Phase 2 . Quantitative and qualitative process data were collected . Facilitators used a st and ardized evaluation form to document participant attendance , and comment on lesson adherence and process delivery . Adolescents and parents completed satisfaction question naires at 2- , 12- and 24-month follow-ups . Following the intervention , 14 adolescents who provided informed written consent were interviewed about their experience with additional therapeutic contact . Data were analysed using descriptive statistics , parametric and non-parametric tests to compare group means , and thematic analyses . Group attendance rates averaged 85 and 47 % during Phases 1 ( 0 - 2 months ) and 2 ( 3 - 24 months ) , respectively . Facilitators frequently noted that participants reported making healthy lifestyle changes . Elements enjoyed in the sessions included practical activities , fun active games , resistance training and forming new friendships . Adolescents struggled with setting specific , measurable , achievable , realistic and timely ( SMART ) goals . Overall , participants were satisfied with the help received including the telephone and electronic contact . More than 80 % of participants found the programme changed adolescents ' eating and physical activity habits , and 89 % of parents reported changing parenting strategies . Future adolescent group-based programmes may enhance participant engagement and programme effectiveness by including more interactive and frequent telephone and electronic contact Background : The WATCH IT programme was developed to address the needs of obese children from disadvantaged communities in Leeds and has been running since January 2004 . Results of the pilot phase , prior to a r and omised controlled trial , are presented . Methods : A process evaluation to assess success of implementation was conducted in December 2004 . User views ( parent and child ) were obtained by semi-structured interviews and focus groups . Change in BMI SD score was calculated for children attending between January 2004 and November 2005 . Results : A total of 94 children ( 49 girls , 45 boys ) , mean age ( SD ) 12.2 ( 2.0 ) years attended . They were moderately to severely obese ( mean BMI SDS 3.09 ( 0.45 ) , with low quality of life and self-image scores . There was a significant reduction in overweight at 6 months ( Δ BMI SD −0.07 ) , especially for teenagers ( Δ BMI SD −0.13 ) and girls ( Δ BMI SD −0.07 ) . The programme was successfully implemented . By December 2004 mean attendance was 2.1 ( 0.7 ) clinics per month , and sports sessions 3.3 ( 1.7 ) sessions per month . Fourteen children dropped out and non-attendance was low ( only 7.5 % sessions missed in 12 months ) . Qualitative research indicated significant appreciation of the service , with reported increase in self-confidence and friendships , and reduction in self-harm . Conclusion : WATCH IT offers a model for a community based service for obese children . The programme suggests that effective care can be delivered by health trainers supervised by health professionals , and so potentially provides a cost effective programme within children ’s communities . These findings are encouraging , and need to be substantiated by extension to other locations and evaluation by r and omised controlled trial BACKGROUND Purpose was to examine experiences of obese youth aged 14 to 18 years during their participation in the Healthy Eating , Aerobic , and Resistance Exercise in Youth ( HEARTY ) r and omized controlled exercise trial . METHODS A longitudinal qualitative approach was used to investigate youths ' experiences across time points in the trial : 3-weeks ( run-in phase ; n = 44 , 52 % males ) , 3-months ( midpoint ; n = 25 ) , and 6-months ( end of intervention ; n = 24 ) . Participants completed telephone interviews on perceived exercise facilitators , barriers , outcomes , and program preferences . Responses were subject to content analyses and are reported as frequencies . RESULTS Participants joined the trial initially to lose weight , but focused more on fitness over time . Exercise behavior was influenced by a sense of achieving results , and by family and peers ( ie , supportive comments , transportation ) . At 6-months , the most commonly perceived changes were improved fitness ( 50 % ) and appearance ( 46 % ) . Suggested changes to the HEARTY trial included initial guidance by a trainer , and more varied and group-based activity . CONCLUSIONS Exercise facilitators , barriers and perceived changes in an exercise trial are reported . Access to a gym , initial direction by a trainer , variety , and group-based activities were reported as desired components of an exercise intervention . Findings also point to the importance of involving family and peer supports OBJECTIVES To assess changes in overweight and obesity between adolescence and young adulthood . DESIGN Prospect i ve 8-wave cohort study in Victoria , Australia , with 1,520 adolescents tracked from the age of 14 for a period of 10 years . MAIN OUTCOME MEASURES Participants aged < 18 years were classified as non-overweight , overweight , or obese according to International Obesity Taskforce cutoff points . In those aged > 18 years overweight was defined as a body mass index ( BMI ) ≥ 25 ; and obesity as a BMI ≥ 30 . RESULTS The proportion of overweight individuals increased from 20 % in mid-adolescence to 33 % at the age of 24 years . Obesity increased from 3.6 % to 6.7 % . Approximately 40 % of young adults with a BMI ≥ 25 had been persistently at normal weights during adolescence and approximately 80 % had been at a normal weight at some point . Around half of obese young adults had never been classified as obese as adolescents . No individual with persistent obesity in adolescence had a BMI < 25 at 24 years . A total of 31 % of females and 59 % of males who had been overweight for only one or two waves of adolescent data collection had a BMI ≥ 25 at 24 years . CONCLUSIONS Substantial shifts in overweight and obesity occur between adolescence and young adulthood ; the extent of continuity depends on both the severity and persistence of adiposity in adolescence . Few adolescents who peak into obesity or are persistently overweight achieve a normal weight in young adulthood . Resolution is more common in those who are less persistently overweight as teenagers , suggesting scope for lifestyle interventions in this subgroup BACKGROUND Adolescence is a critical time to intervene and establish healthy long-term behaviors to decrease the impact of adult obesity in the future . The purpose of this study was to identify key intervention strategies and techniques for community interventions by analyzing the short-term and longer-term shared experiences of both adolescents with overweight or obesity and their parents involved in a community-based , healthy lifestyle intervention . METHODS Qualitative interviews and focus groups were conducted with teens ( aged 12 - 16 years with a BMI above the 85th percentile ) and their parents immediately following the 8-week intervention ( n = 37 teens , n = 33 parents ) and at 12 months follow-up ( n = 23 teens , n = 20 parents ) . Results were analyzed thematically . RESULTS Both teens and parents reported high satisfaction with the program . Immediately following the 8-week intervention , teens reported enjoying participating in exercise with similar peers . Parents described inaccurate expectations from the program . After the 12-month follow-up , teens reported struggling with a cyclical pattern of health behaviors , and parents described a sense of loss following the intensive program and improved communication skills with their adolescent . CONCLUSIONS Several practical strategies emerged for use in future community programs for adolescents with overweight or obesity . Future programs should consider management of expectations , perceptions vs. outcomes , and the cyclical nature of behavior change in adolescents . Strategies for future health behavior change interventions with overweight adolescents should address time management , translation of knowledge into behavior change , successful implementation of practical goal - setting strategies , and increasing intrinsic motivation BACKGROUND In an effort to enhance the vividness and personal relevance of a text messaging intervention to promote weight loss among obese adolescents , a modified Photovoice process was evaluated with adolescents in a weight management program . METHODS Photovoice is a method using photography to generate relevant images and stories from users . Participants were recruited from the Michigan Pediatric Outpatient Weight Evaluation and Reduction ( MPOWER ) program , a multidisciplinary weight management program for obese adolescents and their parents . Twenty-three adolescents with a mean BMI of 40 were asked to take pictures on three to five r and omly assigned weight-related topics , such as “ something that reminds you to exercise , ” and to text them to a research assistant . Adolescents then engaged in semistructured interviews about the experience . Detailed notes of the interviews were analyzed to identify themes . RESULTS Participants generally provided high ratings of the process , indicating that ( 1 ) deciding what pictures to take caused them to reflect on their weight loss experience , and ( 2 ) a mobile intervention incorporating personally relevant images ( e.g. , basketball as their favorite sport rather than sports in general ) would increase treatment adherence . The su bmi tted photographs frequently featured family members and friends , and participants indicated that family and friends played a major role in motivating and supporting them . CONCLUSIONS This study suggests that a Photovoice component has the potential to enhance weight management programs for teens as part of a text messaging intervention and as an independent entity . Further work should evaluate the effect of this promising intervention on weight loss A qualitative study nested within a r and omized controlled trial explored obese adolescents ' experiences of participation in an exercise therapy intervention . Semi-structured interviews were conducted with participants assigned to exercise therapy . Participants ' reported feeling more energetic during and after exercise , than before . Many participants reported feeling happy/happier and expressed feeling better about themselves as individuals after the intervention . Most participants felt more confident in their ability to exercise regularly . Greater emphasis needs to be placed upon educating obese adolescents about the wide range of health benefits that exercise can provide , and that weight loss , while important , is only one such benefit INTRODUCTION There has been a paucity of theory-based interventions to improve health outcomes in overweight adolescents . Therefore , two intervention studies were conducted to : ( a ) determine the feasibility of implementing the Creating Opportunities for Personal Empowerment ( COPE ) Healthy Lifestyles Thinking , Emotions , Exercise , and Nutrition ( TEEN ) program with overweight adolescents ; ( b ) obtain feedback that could be used to refine the program ; and ( c ) examine the preliminary efficacy of the COPE program on the adolescents ' weight and body mass index ( BMI ) . METHOD Phase I and Phase II clinical trials were conducted with 23 overweight teens . The Phase 1 trial used a pre-experimental design with one group of 11 urban adolescents . The Phase 2 trial was conducted with 12 suburban teens using a r and omized controlled pilot study . COPE teens received a 15-session cognitive-behavioral skills building program that included physical activity , while the control group received an attention control program . Weight change and BMI were the key outcomes . RESULTS COPE teens experienced a significantly greater reduction in weight and BMI than did teens in \n Output:\n " }, { "from": "agent", "value": "Key themes included ensuring adolescents receive a ' tailored intervention ' that involves ' active engagement ' .\nSupport from professionals , family and peers were valued highly .\nAdolescents expressed ' prior fears of attending interventions ' and wanted ' longer term support ' . '\nEnjoyment of sport and physical activity ' was evident , and adolescents were strongly motivated by improving body image and social desirability .\nDISCUSSION Considering the views of adolescents attending obesity interventions may help to inform policy makers in the development of future interventions .\nThis may lead to an improvement in recruitment and attrition rates" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Many Japanese reports of acupuncture and moxibustion for chronic pain are not listed in medical data bases such as Medline . Therefore , they are not easily accessible to research ers outside of Japan . To complement existing review s of acupuncture and moxibustion for chronic pain and to provide more detailed discussion and analysis , we did a literature search using ‘ Igaku Chuo Zasshi We d ’ ( Japana Centra Revuo Medicina ) and ‘ Citation Information by National Institute of Information ’ covering the period 1978–2006 . Original articles and case reports of acupuncture and moxibustion treatment of chronic pain were included . Animal studies , surveys , and news articles were excluded . Two independent review ers extracted data from located articles in a pre-defined structured way , and assessed the likelihood of causality in each case . We located 57 papers written in Japanese ( 20 full papers , 37 case reports ) . Conditions examined were headache ( 12 trials ) , chronic low back pain ( 9 trials ) , rheumatoid arthritis ( 8 trials ) , temporom and ibular dysfunction ( 8 trials ) , katakori ( 8 trials ) and others ( 12 trials ) . While 23 were described as clinical control trials ( CCTs ) , 11 employed a quasi-r and om method . Applying the 5-point Jadad quality assessment scoring system , the mean score was 1.5 ± 1.3 ( SD ) . Eleven ( 52 % ) of the CCTs were conducted to determine a more effective procedure for acupuncture ; these compared a certain type of acupuncture with another type of acupuncture or specific additional points . In particular , the trigger point acupuncture was widely used to treat chronic low back pain in Japan . Many reports of chronic pain treatment by acupuncture and moxibustion are listed in Japanese data bases . From the data , we conclude that there is limited evidence that acupuncture is more effective than no treatment , and inconclusive evidence that trigger point acupuncture is more effective than placebo , sham acupuncture or st and ard care BACKGROUND Fibromyalgia is a chronic pain syndrome associated with sleep disorders , fatigue and psychological symptoms . Combinations therapies , such as electrotherapy and therapeutic exercises have been used in the clinical practice . AIM To assess the efficacy of high-frequency transcutaneous electrical nerve stimulation ( TENS ) as an adjuvant therapy to aerobic and stretching exercises , for the treatment of fibromyalgia . DESIGN Controlled clinical trial . SETTING Unit of rehabilitation of a public hospital . POPULATION Twenty-eight women aged 52.4±7.5 years , with fibromyalgia . METHODS A visual analogue scale measured pain intensity ; tender points pain threshold , by dolorimetry ; and quality of life , by the Fibromyalgia Impact Question naire . All subjects participated in an eight-week program consisting of aerobic exercises , followed by static stretching of muscle chains . In TENS group , high-frequency ( 150 Hz ) was applied on bilateral tender points of trapezium and supraspinatus . RESULTS TENS group had a greater pain reduction ( mean change score=-2.0±2.9 cm ) compared to Without TENS group ( -0.7±3.7 cm ) . There was a difference between mean change scores of each group for pain threshold ( right trapezium : 0.2±1 kg/cm² in TENS group and -0.2±1.2 kg/cm² in Without TENS group ) . In the evaluation of clinical ly important changes , patients receiving TENS had relevant improvement of pain , work performance , fatigue , stiffness , anxiety and depression compared to those not receiving TENS . CONCLUSION It has suggested that high-frequency TENS as an adjuvant therapy is effective in relieving pain , anxiety , fatigue , stiffness , and in improving ability to work of patients with fibromyalgia . CLINICAL REHABILITATION IMPACT High-frequency TENS may be used as a short-term complementary treatment of fibromyalgia OBJECTIVE To test the hypothesis that acupuncture improves symptoms of fibromyalgia . PATIENTS AND METHODS We conducted a prospect i ve , partially blinded , controlled , r and omized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture . All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture . We measured symptoms with the Fibromyalgia Impact Question naire ( FIQ ) and the Multidimensional Pain Inventory at baseline , immediately after treatment , and at 1 month and 7 months after treatment . The trial was conducted from May 28 , 2002 , to August 18 , 2003 . RESULTS Fifty patients participated in the study : 25 in the acupuncture group and 25 in the control group . Total fibromyalgia symptoms , as measured by the FIQ , were significantly improved in the acupuncture group compared with the control group during the study period ( P = .01 ) . The largest difference in mean FIQ total scores was observed at 1 month ( 42.2 vs 34.8 in the control and acupuncture groups , respectively ; P = .007 ) . Fatigue and anxiety were the most significantly improved symptoms during the follow-up period . However , activity and physical function levels did not change . Acupuncture was well tolerated , with minimal adverse effects . CONCLUSION This study paradigm allows for controlled and blinded clinical trials of acupuncture . We found that acupuncture significantly improved symptoms of fibromyalgia . Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety Summary Pain and fatigue during movement , but not at rest , are reduced by a onetime 30‐m treatment with active transcutaneous electrical nerve stimulation ( TENS ) in individuals with fibromyalgia . Abstract Because transcutaneous electrical nerve stimulation ( TENS ) works by reducing central excitability and activating central inhibition pathways , we tested the hypothesis that TENS would reduce pain and fatigue and improve function and hyperalgesia in people with fibromyalgia who have enhanced central excitability and reduced inhibition . The current study used a double‐blinded r and omized , placebo‐controlled cross‐over design to test the effects of a single treatment of TENS with people with fibromyalgia . Three treatments were assessed in r and om order : active TENS , placebo TENS and no TENS . The following measures were assessed before and after each TENS treatment : pain and fatigue at rest and in movement ; pressure pain thresholds , 6‐m walk test , range of motion ; 5‐time sit‐to‐st and test , and single‐leg stance . Conditioned pain modulation was completed at the end of testing . There was a significant decrease in pain and fatigue with movement for active TENS compared to placebo and no TENS . Pressure pain thresholds increased at the site of TENS ( spine ) and outside the site of TENS ( leg ) when compared to placebo TENS or no TENS . During active TENS , conditioned pain modulation was significantly stronger compared to placebo TENS and no TENS . No changes in functional tasks were observed with TENS . Thus , the current study suggests TENS has short‐term efficacy in relieving symptoms of fibromyalgia while the stimulator is active . Future clinical trials should examine the effects of repeated daily delivery of TENS , similar to the way in which TENS is used clinical ly on pain , fatigue , function , and quality of life in individuals with fibromyalgia OBJECTIVE --To determine the efficacy of electroacupuncture in patients with fibromyalgia , a syndrome of unknown origin causing diffuse musculoskeletal pain . DESIGN --Three weeks ' r and omised study with blinded patients and evaluating physician . SETTING --University divisions of physical medicine and rehabilitation and rheumatology , Geneva . PATIENTS --70 patients ( 54 women ) referred to the division for fibromyalgia as defined by the American College of Rheumatology . INTERVENTIONS -- Patients were r and omised to electroacupuncture ( n = 36 ) or a sham procedure ( n = 34 ) by means of an electronic numbers generator . MAIN OUTCOME MEASURES --Pain threshold , number of analgesic tablets used , regional pain score , pain recorded on visual analogue scale , sleep quality , morning stiffness , and patient 's and evaluating physician 's appreciation . RESULTS --Seven of the eight outcome parameters showed a significant improvement in the active treatment group whereas none were improved in the sham treatment group . Differences between the groups were significant for five of the eight outcome measures after treatment . CONCLUSIONS --Electroacupuncture is effective in relieving symptoms of fibromyalgia . Its potential in long term management should now be studied Fibromyalgia is characterized by a range of symptoms that include muscle pain , fatigue and sleep disorders . Transcutaneous electrical nerve stimulation ( TENS ) is an established method for pain relief . The purpose of the study was to evaluate the effectiveness and safety of the use of two simultaneously new TENS devices for fibromyalgia pain . After Ethics approval and informed consent , 39 patients were prospect ively divided into three groups to evaluate TENS device , applied simultaneously in each patient : ( 1 ) at the lower back ( perpendicular to the vertebrae canal , at the level of the 5th lumbar vertebrae ) and ( 2 ) central ly above and below the space between the C7 and T1 spinous processes . The devices were applied for 20 min at 12-h interval during 7 consecutive days . For the placebo group ( PG ) , the devices did not transmitted electrical stimulus . The single-TENS group ( STG ) ( n = 13 ) had one active and one placebo TENS . The DTG applied both active TENS devices at the low back and cervical areas . Diclofenac was used as rescue analgesic . The efficacy measures were pain relief , reduction in use of daily analgesic tablets , quality of sleep and fatigue . The evaluation within groups revealed that patients from DPG refereed no pain relief when compared to their previous VAS pain score ( 8 cm , p > 0.05 ) , while patients from the STG refereed improvement of 2.5 cm in the pain VAS ( previous 8.5 cm compared to 6 cm after treatment ) ( p < 0.05 ) , and the DPG refereed daily maintained reduction of 4 cm in the VAS pain ( previous 8.5–4.3 cm ) ( p < 0.02 ) . Concurrent daily consumption of analgesic tablets was reduced in both STG ( p < 0.05 ) and DTG ( p < 0.02 ) . Comparison among groups revealed that analgesia , as well as quality of sleep and disposition , was DTG > STG > PG ( p < 0.05 ) . Participants subjectively found the active device useful . While the application of a single active TENS improved pain relief in fibromyalgia pain , pain and fatigue were further improved when two active devices were simultaneously applied at the low back and cervical area , with no side effects Background Acupuncture is often used to treat fibromyalgia ( FM ) , but it remains unclear whether acupuncture is effective . This study aims to evaluate the effects of acupuncture on pain and quality of life ( QoL ) in FM patients . Methods Sixteen patients ( 13 women and 3 men aged 25 - 63 years ) suffering from FM were r and omised into two groups : group A ( n = 8) received five acupuncture treatments after the fifth week and group B received ten acupuncture treatments . Outcome measures used in this study were pain intensity ( visual analogue scale , VAS ) and the fibromyalgia impact question naire ( FIQ ) . Results After the fifth week , pain intensity ( U = 25.0 ; P = 0.022 ) in group B decreased and QoL ( U = 24.5 ; P = 0.026 ) improved compared to group A. Conclusion The present study suggests that acupuncture treatment is effective to relieve pain for FM patients in terms of QoL and FIQ This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence UNLABELLED Despite promising preliminary results in treating fibromyalgia ( FM ) pain , no neuromodulation technique has been adopted in clinical practice because of limited efficacy , low response rate , or poor tolerability . This phase II open-label trial aims to define a methodology for a clinical ly effective treatment of pain in FM by establishing treatment protocol s and screening procedures to maximize efficacy and response rate . High-definition transcranial direct current stimulation ( HD-tDCS ) provides targeted subthreshold brain stimulation , combining tolerability with specificity . We aim ed to establish the number of HD-tDCS sessions required to achieve a 50 % FM pain reduction , and to characterize the biometrics of the response , including brain network activation pain scores of contact heat-evoked potentials . We report a clinical ly significant benefit of a 50 % pain reduction in half ( n = 7 ) of the patients ( N = 14 ) , with responders and nonresponders alike benefiting from a cumulative \n Output:\n " }, { "from": "agent", "value": "This meta- analysis indicates that there is low- quality evidence for the effectiveness of ES for pain relief in patients with FM .\nHowever , moderate- quality evidence for the effectiveness of electroacupuncture ( EA ) , combined or not combined with other types of treatment , was found for pain relief ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND There is increased pressure on primary care physicians to monitor oral anticoagulation . OBJECTIVE To test the null hypothesis that oral anticoagulation care can be provided at least as well in primary care through a nurse-led clinic , involving near-patient testing and computerized decision support software , compared with routine hospital management based on a variety of clinical outcome measures . METHODS A r and omized , controlled trial in 12 primary care practice s in Birmingham , Engl and ( 9 intervention and 3 control ) . Two control population s were used : patients individually r and omly allocated as controls in the intervention practice s ( intra practice controls ) and all patients in control practice s ( inter practice controls ) . Intervention practice s ' patients were r and omized to the intervention ( practice -based anticoagulation clinic ) or control ( hospital clinic ) group . The main outcome measure was therapeutic control of the international normalized ratio . RESULTS Three hundred sixty-seven patients were recruited ( 122 intervention patients , 102 intra practice control patients , and 143 inter practice control patients ) . St and ard measures of control of the international normalized ratio ( point prevalence ) showed no significant difference between the intervention and control groups . Data on proportion of time spent in the international normalized ratio range showed significant improvement for patients in the intervention group ( paired t test , P = .008 ) . CONCLUSIONS Nurse-led anticoagulation clinics can be implemented in novice primary care setting s by means of computerized decision support software and near-patient testing . Care given by this model is at least as good as routine hospital follow-up . The model is generalizable to primary health care centers operating in developed health care systems OBJECTIVE To investigate the effect of meal-related self-monitoring of blood glucose on glycemic control and well-being in non-insulin-treated type 2 diabetic patients . RESEARCH DESIGN AND METHODS This 6-month study , which included 6 months of follow-up , adopted a prospect i ve , multicenter , r and omized controlled design . Subjects were r and omized to two groups : one group used a blood glucose-monitoring device , kept a blood glucose/eating diary , and received st and ardized counseling ; the control group received nonst and ardized counseling on diet and lifestyle . The primary efficacy parameter was the change in HbA(1c ) . Secondary efficacy variables included changes in body weight , lipids , and microalbumin and changes in treatment satisfaction and well-being . RESULTS In the per- protocol analysis , the use of a self-monitoring blood glucose device significantly reduced HbA(1c ) levels by 1.0 + /- 1.08 % compared with 0.54 + /- 1.41 % for the control group ( P = 0.0086 ) ; subgroup analysis showed three types of responders . Body weight , total cholesterol , and microalbumin improved when using a glucometer , but there was no statistically significant difference between the two groups . Treatment satisfaction increased in both groups to a similar extent ( P = 0.9 ) . Self-monitoring result ed in a marked improvement of general well-being with significant improvements in the subitems depression ( P = 0.032 ) and lack of well-being ( P = 0.02 ) . CONCLUSIONS Meal-related self-monitoring of blood glucose within a structured counseling program improved glycemic control in the majority of non-insulin-treated type 2 diabetic patients in this study . The finding of three types of responders will be important for future planning of counseling and educational interventions Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity CONTEXT Control of oral anticoagulation therapy has been reported to often be inadequate . Previous retrospective investigations suggest that patients ' self-adjustment of oral anticoagulants may lead to improved control . OBJECTIVE To investigate the effects of patients ' self-management of oral anticoagulation therapy on accuracy of control and measures of treatment-related quality of life . DESIGN R and omized , single-blind , multicenter trial . SETTING AND PARTICIPANTS A total of 179 patients receiving long-term oral anticoagulation treatment were enrolled at 5 referral centers in Germany . INTERVENTION Patients were r and omized to an oral anticoagulation self-management group based on a structured treatment and teaching program and international normalized ratio ( INR ) self-monitoring . The control group received conventional care as provided by family physicians , including referral to specialists if necessary . MAIN OUTCOME MEASURES Deviation of INR values from the individual INR target range ( squared ) and the 5 categories of treatment-related quality of life . RESULTS Deviation of INR value from the mean of the INR target range was significantly lower in the intervention group at 3-month ( squared INR deviation , 0.59 vs 0.95 ; P<.001 ) and 6-month follow-up ( 0.65 vs 0.83 ; P=.03 ) compared with the control group . Also , the intervention group had INR values within the target range more often ( repeated measurement analysis for categorical data , P=.006 ) . The results were mainly due to less frequent suboptimal INR values in the intervention group ( 32.8 % vs 50.0 % [ P=.03 ] at 3-month , and 33.7 % vs 48.2 % [ P=.08 ] at 6-month follow-up ) . Treatment-related quality -of-life measures , especially treatment satisfaction scores , were significantly higher in the intervention group compared with controls . CONCLUSIONS An anticoagulation education program that includes self-management of anticoagulation therapy results in improved accuracy of anticoagulation control and in treatment-related quality -of-life measures . Further studies are needed to describe whether the program will reduce risk of bleeding or thromboembolism The goal of this study was to compare the relative efficacy and cost of self-monitoring of blood glucose ( SMBG ) with routine urine testing in the management of patients with type II ( non-insulin-dependent ) diabetes mellitus not treated with insulin . Fifty-four patients with type II diabetes mellitus , not treated with insulin , who had inadequate glucose control on diet aloneor diet and oral hypoglycemic agents were studied . Patients performed SMBG or urine glucose testing as part of a st and ardized treatment program that also included diet and exercise counseling . During the 6-mo study , both the urine-testing and SMBG groups showed similar improvement in glycemic control ; within each group , there were significant improvements in fasting plasma glucose ( reduction of 1.4 ± 3.2 mM , P < 0.03 ) and glycosylated hemoglobin ( reduction of 2.0 ± 3.4 % , P < 0.01 ) levels . Seventeen ( 31 % ) of54 patients actually normalized their glycosylated hemoglobin values , 9 in the urine-testing group and 8 in the SMBG group . Comparisons between the urine-testing and SMBG groups showed no significant differences in mean fasting plasma glucose ( P > 0.86 ) , glycosylated hemoglobin ( P > 0.95 ) , or weight ( P < 0.19 ) . In patients with type II diabetes mellitus not treated with insulin , SMBG is no more effective , but is 8–12 times more expensive , thanurine testing in facilitating improved glycemic control . Our results do not support widespread use of SMBG in diabetic patients not treated with insulin BACKGROUND Vitamin K antagonist treatment is effective for prevention and treatment of thromboembolic events but frequent laboratory control and dose-adjustment are essential . Small portable devices have enabled patient self-monitoring of anticoagulation and self-adjustment of the dose . We compared this self-management of oral anticoagulant therapy with conventional management by a specialist anticoagulation clinic in a r and omised cross-over study . METHODS 50 patients on long-term oral anticoagulant treatment were included in a r and omised controlled crossover study . Patients were self-managed or were managed by the anticoagulation clinic for a period of 3 months . After this period the alternative strategy was followed for each patient . Prothrombin time ( expressed as international normalised ratio [ INR ] ) were measured at intervals of 1 - 2 weeks in both periods without knowledge of type of management . The primary endpoint was the number of measurements within the therapeutic range ( therapeutic target value + /-50.5 INR units ) . FINDINGS There was no significant difference in the overall quality of control of anticoagulation between the two study periods . Patients were for 55 % and for 49 % of the treatment period within a range of + /-0.5 from the therapeutic target INR during self-management and anticoagulation clinic management , respectively ( p=0.06 ) . The proportion of patients who spent most time in the therapeutic target range was larger during self-management than during anticoagulation clinic-guided management . The odds ratio for a better control of anticoagulation ( defined as the period of time in the therapeutic target range ) during self-management compared with anticoagulation clinic-guided management was 4.6 ( 95 % CI 2.1 - 10.2 ) . A patient-satisfaction assessment showed superiority of self-management over conventional care . INTERPRETATION Self-management of INR in the population in this study is feasible and appears to result in control of anticoagulation that is at least equivalent to management by a specialist anticoagulation clinic . It is also better appreciated by patients . Larger studies are required to assess the effect of this novel management strategy on the incidence of thromboembolic or bleeding complications BACKGROUND Self-management ( SM ) of warfarin by patients is an attractive strategy , particularly if it improves anticoagulation control and can be done safely under minimal physician supervision . OBJECTIVE To compare the effect of SM with physician-management ( PM ) on the maintenance of therapeutic anticoagulation . METHODS A r and omized , open-label eight-month trial was performed . Patients 18 years of age and older were eligible if they were receiving warfarin for at least one month before enrolment and required anticoagulation for at least one year to a target international normalized ratio ( INR ) of 2.0 to 3.0 or 2.5 to 3.5 . Exclusion criteria were a known hypercoaguable disorder , mental incompetence , a language barrier or an inability to attend training sessions . Patients r and omly assigned to SM tested their INR using a point-of-care device ( Pro Time Microcogulation System , International Technidyne Corporation , USA ) and adjusted their warfarin doses using a nomogram . Patients r and omly assigned to PM received usual care from their general practitioner . The primary outcome was to demonstrate 20 % improvement in anticoagulation control by SM . RESULTS One hundred forty patients were r and omly assigned ( 70 per group ) . Thirteen patients dropped out of SM early due to an inability to self-manage . Based on intention-to-treat analysis , there was no difference in the proportion of INR in range ( SM 64.8 % versus PM 58.7 % , P=0.23 ) or time in target range ( SM 71.8 % versus PM 63.2 % , P=0.14 ) . Patients managing their own therapy spent less time below the therapeutic range ( 15.0 % versus 27.3 % , P=0.04 ) . There were three major complications of thrombosis or bleeding , all occurring in the PM arm . All patients who completed SM preferred to continue with that strategy . CONCLUSIONS SM was not significantly better than PM in maintaining therapeutic anticoagulation . SM was feasible and appeared safe in the present study population A diabetes protocol characterized by self-monitoring of blood glucose was introduced in four general practice s with the aim of making the frequency of consultations dependent on the metabolic regulation and emphasizing body weight reduction . The feasibility of the programme was investigated and the results after 1 year were compared with those of conventional care in four control practice s. In the experimental practice s , 13 patients switched from a medical specialist 's to a general practitioner 's supervision , 20 remained under supervision of their GP and 33 started self-monitoring . The self-monitoring rate , the consultation frequency according to protocol , the low number of dropouts and inadequate referrals and adherence to the therapeutic scheme showed that the protocol \n Output:\n " }, { "from": "agent", "value": "Conclusion This paper demonstrates the use of relative attrition as a new tool in systematic review methodology which has the potential to identify patient , intervention and trial characteristics which influences attrition in trials" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Abstract The evaluation of a 13-month maintenance program ( MP ) for 39 severe COPD patients with FEV1%pred 44(7)% who , as result of two different 8-week leg exercise training ( LET ) programs , one supervised at the hospital ( group S ; n = 20 ) and the other self-monitored ( SM ; n = 19 ) , had achieved different levels of exercise tolerance . After LET , patients in group S had a higher maximal oxygen uptake and endurance time than patients in the SM group [ O2max 1.43(0.30 ) l · min−1 ] vs l.25(0.27 ) l · min−1 and endurance-time 16(4 ) min vs 12 ( 5 ) min , respectively ) . During the MP patients were advised to walk vigorously at least 4 km/day , 4 times/wk . After the MP , while endurance time remained higher than at baseline , it had decreased ( p < 0.01 ) immediately after LET in both groups and no differences were evident between groups ( 11(4 ) min and 10(4 ) , respectively ) . In contrast , Chronic Respiratory Diseases Question naire scores , which had improved significantly after LET in both groups , remained high . Long-term effects of MP were independent of the training strategy or whether physiological improvements had been obtained with the initial LET . SM exercise programs do not seem capable of maintaining physiological improvements in exercise tolerance , though “ quality of life ” can be maintained [ Purpose ] Fragmentary studies on characteristics of respiratory muscles are being done to increase respiratory capacity by classifying exercises into voluntary respiratory exercise which relieves symptoms and prevents COPD and exercise using breathing exercise equipment . But this study found changes on respiratory pattern through changes on the activity pattern of agonist and synergist respiratory muscles and studied what effect they can have on body function improvement . [ Subjects and Methods ] Fifteen subjects in experimental group I that respiratory exercise of diaphragm and 15 subjects in experimental group II that feedback respiratory exercise were r and omly selected among COPD patients to find the effective intervention method for COPD patients . And intervention program was conducted for 5 weeks , three times a week , once a day and 30 minutes a session . They were measured with BODE index using respiratory muscle activity , pulmonary function , the six-minute walking test , dyspnea criteria and BMI Then the results obtained were compared and analyzed . [ Results ] There was a significant difference in sternocleidomastoid muscle and scalene muscle and in 6-minute walk and BODE index for body function . Thus the group performing feedback respiratory had more effective results for mild COPD patients . [ Conclusion ] Therefore , the improvement was significant regarding the activity of respiratory muscles synergists when breathing before doing breathing exercise . Although , it is valuable to reduce too much mobilization of respiratory muscles synergists through the proper intervention it is necessary to study body function regarding improvement of respiratory function for patients with COPD STUDY OBJECTIVES The purpose of this study was to compare the effects of endurance training only to endurance plus strength ( combined ) training in a r and omized trial of patients with COPD . METHODS Twenty-four patients completed the study : 11 patients in the combined training group ( FEV(1 ) 45 + /- 5 % predicted ) , and 13 patients in the endurance training group ( FEV(1 ) 40 + /- 4 % predicted ) [ mean + /- SE ] . Muscle strength , quality of life , exercise performance , and quadriceps fatigability were measured before and after rehabilitation . RESULTS Combined training led to significant improvements in quadriceps ( 23.6 % ) , hamstring ( 26.7 ) , pectoralis major ( 17.5 % ) , and latissimus dorsi ( 20 % ) muscle strength . Endurance training alone did not produce significant improvements in muscle strength : quadriceps ( 1.1 % decrease ) , hamstring ( 12.2 % increase ) , pectoralis major ( 7.8 % increase ) , and latissimus dorsi ( 2.8 % decrease ) . The increase in strength after training was significantly greater in the combined group compared to the endurance group for the quadriceps and latissimus dorsi muscles but not for the hamstring and pectoralis major muscles . Six-minute walk distance , endurance exercise time , and quality of life ( as measured by the Chronic Respiratory Question naire ) significantly increased in both groups after rehabilitation with no significant differences in the extent of improvement between groups . The extent of improvement in quadriceps fatigability after training ( assessed by quadriceps twitch force before and after exercise ) was not significantly different between groups . CONCLUSION Strength training can lead to significant improvement in muscle strength in elderly patients with COPD . However , this improvement in muscle strength does not translate into additional improvement in quality of life , exercise performance or quadriceps fatigability compared to that achieved by endurance exercise alone Background . Data on the use and efficacy of complementary and alternative medicine ( CAM ) in patients with asthma are limited , and there is a lack of studies documenting the use of CAM in patients with chronic obstructive pulmonary disease ( COPD ) in Turkey . Aim . To determine the prevalence of CAM usage in patients with asthma and COPD and to assess the clinical and demographic factors associated with the use of CAM . Material s and methods . A total of 521 patients ( 313 with asthma and 208 with COPD ) were r and omly enrolled into this cross-sectional survey . A face-to-face interview was conducted using a structured question naire . Results . One hundred sixty-three patients ( 52 % ) with asthma and 70 patients ( 33 % ) with COPD were reported to be using some form of CAM ( p < 0.001 ) . The most popular modalities were herbal remedies ( 46 % and 28 % in the two groups , respectively ) and animal products ( 28 % and 5 % in the two groups , respectively ) . CAM-practicing asthma patients were typically younger with longer duration of disease and higher income than the CAM-practicing COPD patients . For the patients , the main source of information on CAM practice s was their relatives and friends . Only a small number of the patients consulted with their physicians about CAM . The main reasons to use CAM for patients with asthma and COPD were harmlessness and symptomatic relief , respectively . CAM-related adverse effects and difficulties to obtain CAM were significantly higher in patients with asthma than in patients with COPD . Conclusion . There is a high prevalence of CAM usage in patients with asthma and COPD in Turkey . Hence , becoming familiar with CAM therapy and inquiring about patient practice of CAM as part of the routine medical history will allow the physicians to provide reliable information to their patients on these medical practice In patients with chronic obstructive pulmonary disease ( COPD ) the intensity of aerobic training is limited by dyspnea . Improving strength of the inspiratory muscles could enhance aerobic exercise training by reducing exercise-related dyspnea . We examined effects of home-based inspiratory muscle training ( IMT ) and cycle ergometry training ( CET ) in 53 patients with moderate to severe COPD ( FEV(1)% pred , 50 + /- 17 [ mean + /- SD ] ) . Patients were r and omly assigned to 4 mo of training in one of four groups : IMT , CET , CET + IMT , or health education ( ED ) . Patients were encouraged to train to the limits of their dyspnea . Inspiratory muscle strength and endurance increased in IMT and CET + IMT groups compared with CET and ED groups ( p < 0 . 01 ) . Peak oxygen uptake increased and heart rate , minute ventilation , dyspnea , and leg fatigue decreased at submaximal work rates in the CET and CET + IMT groups compared with the IMT and ED groups ( p < 0 . 01 ) . There were no differences between the CET and CET + IMT groups . Home-based CET produced a physiological training effect and reduced exercise-related symptoms while IMT increased respiratory muscle strength and endurance . The combination of CET and IMT did not produce additional benefits in exercise performance and exercise-related symptoms . This is the first study to demonstrate a physiological training effect with home-based exercise training Background Hypertension is a risk factor for cardiovascular disease , and the prevalence of hypertension tends to increase with age . Current treatments for hypertension have side effects and poor adherence . Qigong has been studied as an alternative therapy for hypertension ; however , the types of qigong used in those studies were diverse , and there have not been many well- design ed r and omized controlled trials . Our objectives are the following : 1 ) To evaluate the effects of qigong on blood pressure , health status and hormone levels for pre- or mild hypertension . 2 ) To test the method ological appropriateness of this clinical trial and calculate a sample size for future r and omized trials . Methods Forty subjects with pre- or mild hypertension will be r and omized to either the qigong exercise group or the non-treated group . Participants in the qigong group will conduct qigong exercises 5 times per week for 8 weeks , and participants in the non-treated group will maintain their current lifestyle , including diet and exercise . The use of antihypertensive medication is not permitted . The primary endpoint is a change in patient blood pressure . Secondary endpoints are patient health status ( as measured by the SF-36 and the MYMOP2 question naires ) and changes in hormone levels , including norepinephrine , epinephrine , and cortisol . Discussion This study will be the first r and omized trial to investigate the effectiveness of qigong exercises for the treatment of pre- and mild hypertension . The results of this study will help to establish the optimal approach for the care of adults with pre- or mild hypertension . Trial registration Clinical Research Information Service Objectives . To evaluate the sustaining effects of Tai Chi Qigong ( TCQ ) in improving the psychosocial health in chronic obstructive pulmonary disease ( COPD ) patients in the sixth month . Background . COPD affects both physical and emotional aspects of life . Measures to minimize patients ' suffering need to be implemented . Methods . 206 COPD patients were r and omly assigned into three groups : TCQ group , exercise group , and control group . The TCQ group completed a three-month TCQ program , the exercise group practice d breathing and walking exercise , and the control group received usual care . Results . Significant group-by-time interactions in quality of life ( QOL ) using St. George 's respiratory question naire ( P = 0.002 ) and the perceived social support from friends using multidimensional scale of perceived social support ( P = 0.04 ) were noted . Improvements were observed in the TCQ group only . Conclusions . TCQ has sustaining effects in improving psychosocial health ; it is also a useful and appropriate exercise for COPD patients Complementary and alternative medicine ( CAM ) use by Australians is substantial and increasing , but little is known about its use by the elderly . We here present the findings for the elderly cohort in our recently conducted national survey on CAM use by adult Australians . In May and June 2005 , computer-assisted telephone interviews , using r and om-digit telephone dialing , were employed to gather data on CAM use in the last 12 months . Of 1067 adult participants interviewed , 178 were 65 or older . More than half of these ( 57.8 % ; 95 % CI , 50.7%-64.9 % ) had used at least one of 17 common forms of CAM and 60.4 % of the CAM users had consulted CAM practitioners . Clinical nutrition , chiropractic , massage therapy , meditation , and herbal medicine were the most common forms of CAM used by the elderly . A higher proportion of the elderly had always used both CAM and conventional medical treatments ( 37.9 % ) than had those aged 18 - 34 ( 15.7 % ) and 35 - 64 ( 26.9 % ) . Elderly CAM users ( 60.2 % ) were more likely than younger users to discuss their use with their doctors . Of those who did not do so , 24.1 % were not asked by their doctors and 16.0 % considered that their doctor would disapprove . In conclusion , we found that a substantial proportion of older Australians use CAM . The elderly are also more likely than younger adults to discuss their use of CAM with their doctors , but doctors need to play a more active role in initiating such communication Aerobic exercise training is used for rehabilitation in patients with chronic obstructive pulmonary disease ( COPD ) , although it has little effect on muscle weakness and atrophy . Resistance training may be a useful addition to aerobic programs for these patients . The purpose of the present study was to investigate the effects of resistance training in addition to aerobic training on functional outcomes in patients with COPD . Seventeen COPD patients enrolled in an aerobic-based program that met twice a week were assigned to a 12-week control/aerobic [ CON : n=8 ; 63 ( 8) years ; mean ( SD ) ] or a resistance/aerobic group [ RES : n=9 ; 61 ( 7 ) years ] . RES trained an additional twice a week on 12 resistance machines , performing three sets of 8–12 repetitions at 32–64 % of their one-repetition maximum ( 1-RM ) lifts . RES ( P<0.05 ) increased upper ( 36 % ) and lower ( 36 % ) body strength , as well as lean body mass ( 5 % ) , while CON showed little to no change . The 12-min walk distance increased ( P<0.05 ) in only the RES [ 676 ( 219 ) to 875 ( 172 ) m ] . Measurements of three of the eight tasks of activities of daily living improved in RES ( P<0.0 \n Output:\n " }, { "from": "agent", "value": "Results : This systematic review and meta- analysis will provide a high- quality synthesis and evaluate the efficacy and safety based on current relevant literature evidence of Liuzijue Qigong intervention for COPD patient .\nConclusion : Our systematic review will provide evidence to determine whether Liuzijue Qigong is an effective and safe approach to prevention and treatment of COPD patients" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: In this double-blind , parallel-group , multicenter study , 169 patients with symptoms of maxillary sinusitis but without radiographically confirmed empyema ( pus ) were r and omly assigned to receive either 500 mg azithromycin once daily for 3 days ( 87 patients ) or placebo daily for 3 days ( 82 patients ) . Nasal secretion , maxillary tenderness and pain , nasal obstruction , general malaise , and hyposmia were assessed at the start of the study and on days 4 , 11 , and 25 of treatment . After 11 days 58 % of the patients in the azithromycin group were cured versus 31 % in the placebo group ; after 25 days the cure rate was 79 % versus 67 % , respectively . When both cure and improvement were considered , the corresponding figures after day 25 were 90 % and 88 % , respectively . Adverse events , predominantly gastrointestinal , occurred in 24 ( 27 % ) of the azithromycin-treated patients and in 15 ( 18 % ) of those treated with placebo , but the difference was not statistically significant . There was a difference in efficacy in favor of azithromycin in the treatment of rhinitis with symptoms of maxillary sinusitis but without radiological signs of empyema ( pus ) . Antibiotics should only be used to alleviate symptoms in patients with moderate to severe symptoms , as the results after 25 days for both improvement and cure are equal . In the treatment of acute rhinitis with symptoms and signs of maxillary sinusitis but without empyema , treatment with azithromycin seems to result in a better cure rate after 10–12 days when compared with placebo OBJECTIVE To compare the efficacy of amoxicillin vs placebo in patients with an acute upper respiratory tract infection and purulent rhinorrhea . STUDY DESIGN Double-blind r and omized placebo-controlled trial . POPULATION The 416 patients included from 69 family practice s were 12 years or older , presenting with acute upper respiratory complaints , and having a history of purulent rhinorrhea and no signs of complications of sinusitis . OUTCOMES MEASURED Therapy success ( disappearance of symptoms that most greatly affected the patient 's health ) at day 10 and duration of general illness , pain , and purulent rhinorrhea . RESULTS Therapy was successful in 35 % of patients with amoxicillin and in 29 % of patients with placebo ( relative risk [ RR ] 1.14 , 95 % confidence interval [ CI ] , 0.92 - 1.42 ) . There was no effect on duration of general illness or pain . Duration of purulent rhinorrhea was shortened by amoxicillin ( 9 days vs 14 for clearing of purulent rhinorrhea in 75 % of patients ; P = .007 ) . Diarrhea was more frequent with amoxicillin ( 29 % vs 19 % , RR 1.28 , 95 % CI , 1.05 - 1.57 ) . No complications were reported . One patient ( 0.5 % ) receiving amoxicillin and 7 ( 3.4 % ) receiving placebo discontinued trial therapy because of exacerbation of symptoms ( RR 0.25 , 95 % CI 0.04 - 1.56 , P = .07 ) . All 8 patients recovered with antibiotic therapy . CONCLUSIONS Amoxicillin has a beneficial effect on purulent rhinorrhea caused by an acute infection of the nose or sinuses but not on general recovery . The practical implication is that all such patients , whatever the suspected diagnosis , can be safely treated with symptomatic therapy and instructed to return if symptoms worsen In this double-blind study of 60 infants with undifferentiated respiratory diseases , antibiotics seemed of no benefit in shorten ing the median duration of illness or in preventing secondary complications . The conclusion is drawn that the danger of complications from the antibiotics them selves is greater than the good which many physicians believe that antibiotics produce in such diseases preparation , and phenylephrine plus nitrofurazone 0.02 per cent solution t as the test preparation . Each was dispensed in a plastic dropping container marked only with a code number ; neither patient nor physician knew to which group the patient had been assigned . All 100 patients ---541 in each group-were from a general practice in pediatrics and had purulent rhinitis . Each patient was provided A double-blind r and omized controlled trial of amoxycillin , co-trimoxazole , and placebo was conducted on 197 children presenting with presumed viral respiratory infections . Routine throat swabs were taken to exclude streptococcal diseases . The three disease categories studied -- nasopharyngitis , pharyngotonsillitis , and bronchitis ( including laryngotracheobronchitis)--showed a generally similar pattern of resolution irrespective of treatment . Nevertheless , seven out of 66 children receiving placebo were withdrawn from the trial with unremitting symptoms or complications thought to require antimicrobial treatment . Only two of 56 children receiving amoxycillin and none of 75 receiving co-trimoxazole were withdrawn . Three other children receiving amoxycillin and three receiving placebo were seen during the trial but further treatment was not thought to be necessary . Thus the return consultation rate in children receiving placebo therapy was 15 % compared with 4 % for those receiving antimicrobial treatment . Antimicrobial treatment was associated with less nasal discharge on the eighth day of treatment . Placebo treatment allowed an earlier return to normal activity . There was a high incidence of possible side effects on all regimens including placebo . It is concluded that the benefits of antimicrobial treatment in presumed viral respiratory infections are marginal , and they should not be routinely prescribed for these conditions Purulent nasal discharge ( discharge that is thick , opaque and colored ) is a common clinical symptom in pediatrie patients . Although it may occur at any age it is probably most problematic and most common in children between birth and 2 to 3 years of age . This article review s the differential diagnosis , evaluation and management of purulent nasal discharge in children The benefits of antibiotic treatment and a nasopharyngeal culture in children with longst and ing cough were analysed in a prospect i ve r and omized open study . Clinical ly suspected pertussis was excluded . Of 40 children given erythromycin for 7 days , 35 ( 88 % ) recovered in one week , compared with 17/47 ( 36 % ) untreated ( p < 0.0001 ) . Erythromycin eliminated Moraxella catarrhalis from the nasopharynx in 21/31 children ( 68 % ) , compared with spontaneous disappearance in 7/35 ( 20 % ) untreated controls ( p < 0.001 ) . Purulent bronchitis or otitis media occurred in 2 children ( 5 % ) in the treatment group and in 21 ( 45 % ) in the control group ( p < 0.01 ) . To evaluate the clinical role of isolated pathogens , the 47 untreated subjects were studied . Seven of 35 children harbouring M. catarrhalis recovered , compared with 8/12 in whom this bacterium was absent ( p < 0.01 ) . No correlation was found between the isolation of Haemophilus influenzae or Streptococcus pneumoniae and the clinical outcome . Children with persistent cough > 10 days may benefit from erythromycin treatment . M. catarrhalis in the nasopharynx indicates prolonged symptoms and increased risk of bacterial complications Effectiveness and clinical tolerance of the tixocortol-neomycin combination ( Pivalone-Neomycin nasal suspension ) used as monotherapy were evaluated in a double-blind placebo-controlled study ( placebo : vehicle i.e. , N-cetylpyridinium chloride , sodium chloride , sodium hydroxide solution , benzyl alcohol , purified water , monosodium phosphate ) in 211 pediatric patients ( aged 6 months to 8 years ) with uncomplicated acute rhinopharyngitis . After seven days therapy , improvement in symptoms of acute rhinopharyngitis , especially rhinorrhea and nocturnal cough , was greater in the tixocortol-neomycin group . Physical evaluation documented significant improvements in local superinfection with disappearance of mucopurulent nasal secretions and posterior drip . Locoregional outcome , evaluated on severity of infectious complications and antibiotic use , was also more favorable in the tixocortol-neomycin group . These results , together with the good clinical tolerance of the study drug , demonstrate the value of single-drug therapy with this local corticosteroid-neomycin combination in children with uncomplicated acute rhinopharyngitis . They confirm that local administration of corticosteroids to combat inflammatory phenomena is useful not only in the well-recognized lower respiratory tract indications ( asthma , respiratory syncitial virus infections ) but also in nasal diseases ( rhinitis ) AIM To assess General Practice ( GP ) description and management of upper respiratory tract infections ( URTI ) , including conditions under which they prescribe antibiotics . METHOD A telephone survey of a r and omised sample of Auckl and GPs . RESULTS There was a 61 % response rate . 82 of the 100 GPs interviewed agreed that most patients presenting with URTI expected antibiotics . Persistent symptoms and indication of specific infection ( tonsillitis , otitis media , sinusitis , pharyngitis , purulent sputum ) were common reasons for prescribing . Patients travelling overseas , expecting or requesting antibiotics and prior use of over-the-counter ( OTC ) medications increased antibiotic prescribing-rates . Most GPs ( 95 % ) issued as-needed prescriptions on occasion ; 13 % did this often . Amoxicillin and amoxicillin/clavulanic acid were most commonly used . Despite wide-ranging antibiotic use for URTI ( 0 to 90 % ) , only 6 % of GPs felt they prescribed more antibiotics than others . CONCLUSIONS The results suggest over-prescription is common-place , but use of as-needed prescriptions to reduce antibiotic use is encouraging . Exploration of patient expectations in the consultation may assist in decreasing prescribing rates The clinical responses of children with upper respiratory infections to 1 of 3 treatment regimens ( tetracycline , penicillin , and placebo ) were evaluated in relation to the bacterial and viral pathogens cultured from nasopharyngeal swabs . The 3 treatment groups were similar in size and in the frequency and type of pathogens recovered . The groups did not differ in their response to the treatment regimens in terms of mean duration of fever , failure to improve , the development of complications , or the persistance of bacterial pathogens in the nasopharynx This preliminary study evaluated the effectiveness of enteric-coated erythromycin in the treatment of adults with nonstreptococcal pharyngitis . Twenty-six patients , aged 12 or older , with nonstreptococcal pharyngitis were r and omly assigned in a double-blind fashion to receive either enteric-coated erythromycin or placebo for 10 days . Each day the patients rated the soreness of their throats and how sick they felt . The use of erythromycin appeared to decrease the median number of days for the feeling of sickness to improve ( two days versus four days , P less than .01 ) as well as to decrease the median number of days for the feeling of sickness to resolve ( three- and -a-half days versus five days , P less than .05 ) . This apparent improvement in sickness occurred even though there was no significant decrease in the soreness of the throat in patients treated with erythromycin compared to those patients treated with placebo . Treatment with enteric-coated erythromycin appeared to shorten the time until improvement in this group of adults with nonstreptococcal pharyngitis Abstract The recommended treatment for mild acute respiratory infections ( ARI ) in children is supportive care only , but many physicians , especially in developing countries , continue to prescribe antibiotic treatment because they believe it prevents progression to more severe ARI . To find out whether ampicillin treatment conferred any benefit over supportive care alone , a r and omised , controlled trial was carried out among 889 children ( under 5 years ) with mild ARI in Indonesia . 447 were r and omly allocated ampicillin ( 25 - 30 mg/kg body weight three times daily for 5 days ) plus supportive care ( continued breastfeeding , clearing of the nose , and paracetamol to control fever ) ; 442 were allocated supportive care only . The treatment groups were almost identical after r and omisation in terms of age , sex , level of parental education , history of measles immunisation , and fever . After 1 week the percentages cured were nearly identical ( 204 [ 46 % ] ampicillin ; 209 [ 47 % ] control ) , as were the percentages of cases progressing to moderate ARI ( 56 [ 13 % ] vs 53 [ 12 % ] ) . The effect of treatment was not modified by age , sex , measles immunisation status , or the educational level of the parents . At the 2-week follow-up , the percentages cured were 62 % ( 277 ) in the ampicillin group and 58 % ( 256 ) in the control group ; 14 % of both groups had progressed to moderate \n Output:\n " }, { "from": "agent", "value": "There is no evidence of benefit from antibiotics for the common cold or for persisting acute purulent rhinitis in children or adults .\nThere is evidence that antibiotics cause significant adverse effects in adults when given for the common cold and in all ages when given for acute purulent rhinitis ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Primary pulmonary hypertension is a progressive disease for which no treatment has been shown in a prospect i ve , r and omized trial to improve survival . METHODS We conducted a 12-week prospect i ve , r and omized , multicenter open trial comparing the effects of the continuous intravenous infusion of epoprostenol ( formerly called prostacyclin ) plus conventional therapy with those of conventional therapy alone in 81 patients with severe primary pulmonary hypertension ( New York Heart Association functional class III or IV ) . RESULTS Exercise capacity was improved in the 41 patients treated with epoprostenol ( median distance walked in six minutes , 362 m at 12 weeks vs. 315 m at base line ) , but it decreased in the 40 patients treated with conventional therapy alone ( 204 m at 12 weeks vs. 270 m at base line ; P < 0.002 for the comparison of the treatment groups ) . Indexes of the quality of life were improved only in the epoprostenol group ( P < 0.01 ) . Hemodynamics improved at 12 weeks in the epoprostenol-treated patients . The changes in mean pulmonary-artery pressure for the epoprostenol and control groups were -8 percent and + 3 percent , respectively ( difference in mean change , -6.7 mm Hg ; 95 percent confidence interval , -10.7 to -2.6 mm Hg ; P < 0.002 ) , and the mean changes in pulmonary vascular resistance for the epoprostenol and control groups were -21 percent and + 9 percent , respectively ( difference in mean change , -4.9 mm Hg/liter/min ; 95 percent confidence interval , -7.6 to -2.3 mm Hg/liter/min ; P < 0.001 ) . Eight patients died during the study , all of whom had been r and omly assigned to conventional therapy ( P = 0.003 ) . Serious complications included four episodes of catheter-related sepsis and one thrombotic event . CONCLUSIONS As compared with conventional therapy , the continuous intravenous infusion of epoprostenol produced symptomatic and hemodynamic improvement , as well as improved survival in patients with severe primary pulmonary hypertension Background — Eisenmenger syndrome is characterized by the development of pulmonary arterial hypertension with consequent intracardiac right-to-left shunt and hypoxemia in patients with preexisting congenital heart disease . Because Eisenmenger syndrome is associated with increased endothelin expression , patients may benefit from endothelin receptor antagonism . Theoretically , interventions that have some effect on the systemic vascular bed could worsen the shunt and increase hypoxemia . Methods and Results — The Bosentan R and omized Trial of Endothelin Antagonist Therapy-5 ( BREATHE-5 ) was a 16-week , multicenter , r and omized , double-blind , placebo-controlled study evaluating the effect of bosentan , a dual endothelin receptor antagonist , on systemic pulse oximetry ( primary safety end point ) and pulmonary vascular resistance ( primary efficacy end point ) in patients with World Health Organization functional class III Eisenmenger syndrome . Hemodynamics were assessed by right- and left-heart catheterization . Secondary end points included exercise capacity assessed by 6-minute walk distance , additional hemodynamic parameters , functional capacity , and safety . Fifty-four patients were r and omized 2:1 to bosentan ( n=37 ) or placebo ( n=17 ) for 16 weeks . The placebo-corrected effect on systemic pulse oximetry was 1.0 % ( 95 % confidence interval , −0.7 to 2.8 ) , demonstrating that bosentan did not worsen oxygen saturation . Compared with placebo , bosentan reduced pulmonary vascular resistance index ( −472.0 dyne · s · cm−5 ; P=0.0383 ) . The mean pulmonary arterial pressure decreased ( −5.5 mm Hg ; P=0.0363 ) , and the exercise capacity increased ( 53.1 m ; P=0.0079 ) . Four patients discontinued as a result of adverse events , 2 ( 5 % ) in the bosentan group and 2 ( 12 % ) in the placebo group . Conclusions — In this first placebo-controlled trial in patients with Eisenmenger syndrome , bosentan was well tolerated and improved exercise capacity and hemodynamics without compromising peripheral oxygen saturation Background In a previous study , 6-minute walk distance ( 6MWD ) improvement with sildenafil was not dose dependent at the 3 doses tested ( 20 , 40 , and 80 mg 3 times daily [ TID ] ) . This study assessed whether lower doses were less effective than the approved 20-mg TID dosage . Methods Treatment-naive patients with pulmonary arterial hypertension were r and omized to 12 weeks of double-blind sildenafil 1 , 5 , or 20 mg TID ; 12 weeks of open-label sildenafil 20 mg TID followed . Changes from baseline in 6-minute walk distance ( 6MWD ) for sildenafil 1 or 5 mg versus 20 mg TID were compared using a Williams test . Hemodynamics , functional class , and biomarkers were assessed . Results The study was prematurely terminated for non-safety reasons , with 129 of 219 planned patients treated . At week 12 , 6MWD change from baseline was significantly greater for sildenafil 20 versus 1 mg ( P = 0.011 ) but not versus 5 mg . At week 24 , 6MWD increases from baseline were larger in those initially r and omized to 20 versus 5 or 1 mg ( 74 vs 50 and 47 m , respectively ) . At week 12 , changes in hemodynamic parameters were generally small and variable between treatment groups ; odds ratios for improvement in functional class were not statistically significantly different . Improvements in B-type natriuretic peptide levels were significantly greater with sildenafil 20 versus 1 but not 5 mg . Conclusions Sildenafil 20 mg TID appeared to be more effective than 1 mg TID for improving 6MWD ; sildenafil 5 mg TID appeared to have similar clinical and hemodynamic effects as 20 mg TID.Trial registration Clinical Trials.gov NCT00430716 ( Registration date : January 31 , 2007 ) BACKGROUND Pulmonary hypertension ( PH ) is a well-known independent prognostic factor in chronic obstructive pulmonary disease ( COPD ) and a sufficient criterion for lung transplant c and idacy . Limited data are currently available on the hemodynamic and clinical effect of phosphodiesterase 5 inhibitors in patients with severe PH associated with COPD . This study assessed the effect of sildenafil on pulmonary hemodynamics and gas exchange in severe PH associated with COPD . METHODS After screening , this multicenter , r and omized , placebo-controlled double-blind trial r and omized patients to receive 20 mg sildenafil or placebo 3 times a day ( ratio 2:1 ) for 16 weeks . The primary end point was the reduction in pulmonary vascular resistance . Secondary end points included BODE ( body mass index , airflow obstruction , dyspnea , and exercise capacity ) index , 6-minute walk test , and quality of life question naire . Changes in the partial pressure of arterial oxygen were evaluated as a safety parameter . RESULTS The final population included 28 patients , 18 in the sildenafil group and 10 in the placebo group . At 16 week , patients treated with sildenafil had a decrease in pulmonary vascular resistance ( mean difference with placebo -1.4 WU ; 95 % confidence interval , ≤ -0.05 ; p = 0.04 ) . Sildenafil also improved the BODE index , diffusion capacity of the lung for carbon monoxide percentage , and quality of life . Change from baseline in the partial pressure of arterial oxygen was not significantly different between the sildenafil and placebo groups . CONCLUSIONS This pilot study found that treatment with sildenafil reduced pulmonary vascular resistance and improved the BODE index and quality of life , without a significant effect on gas exchange OBJECTIVES The purpose of this study was to assess the safety and efficacy of the oral prostacyclin analogue beraprost sodium during a 12-month double-blind , r and omized , placebo-controlled trial in patients with pulmonary arterial hypertension ( PAH ) . BACKGROUND Pulmonary arterial hypertension is a progressive disease that ultimately causes right heart failure and death . Despite the risks from its delivery system , continuous intravenous epoprostenol remains the most efficacious treatment currently available . METHODS A total of 116 patients with World Health Organization ( WHO ) functional class II or III primary pulmonary hypertension or PAH related to either collagen vascular diseases or congenital systemic to pulmonary shunts were enrolled . Patients were r and omized to receive the maximal tolerated dose of beraprost sodium ( median dose 120 microg four times a day ) or placebo for 12 months . The primary end point was disease progression ; i.e. , death , transplantation , epoprostenol rescue , or > 25 % decrease in peak oxygen consumption ( VO(2 ) ) . Secondary end points included exercise capacity assessed by 6-min walk test and peak VO(2 ) , Borg dyspnea score , hemodynamics , symptoms of PAH , and quality of life . RESULTS Patients treated with beraprost exhibited less evidence of disease progression at six months ( p = 0.002 ) , but this effect was not evident at either shorter or longer follow-up intervals . Similarly , beraprost-treated patients had improved 6-min walk distance at 3 months by 22 m from baseline and at 6 months by 31 m ( p = 0.010 and 0.016 , respectively ) compared with placebo , but not at either 9 or 12 months . Drug-related adverse events were common and were related to the disease and /or expected prostacyclin adverse events . CONCLUSIONS These data suggest that beneficial effects may occur during early phases of treatment with beraprost in WHO functional class II or III patients but that this effect attenuates with time BACKGROUND In a phase 2 trial , selexipag , an oral selective IP prostacyclin-receptor agonist , was shown to be beneficial in the treatment of pulmonary arterial hypertension . METHODS In this event-driven , phase 3 , r and omized , double-blind , placebo-controlled trial , we r and omly assigned 1156 patients with pulmonary arterial hypertension to receive placebo or selexipag in individualized doses ( maximum dose , 1600 μg twice daily ) . Patients were eligible for enrollment if they were not receiving treatment for pulmonary arterial hypertension or if they were receiving a stable dose of an endothelin-receptor antagonist , a phosphodiesterase type 5 inhibitor , or both . The primary end point was a composite of death from any cause or a complication related to pulmonary arterial hypertension up to the end of the treatment period ( defined for each patient as 7 days after the date of the last intake of selexipag or placebo ) . RESULTS A primary end-point event occurred in 397 patients --41.6 % of those in the placebo group and 27.0 % of those in the selexipag group ( hazard ratio in the selexipag group as compared with the placebo group , 0.60 ; 99 % confidence interval , 0.46 to 0.78 ; P<0.001 ) . Disease progression and hospitalization accounted for 81.9 % of the events . The effect of selexipag with respect to the primary end point was similar in the subgroup of patients who were not receiving treatment for the disease at baseline and in the subgroup of patients who were already receiving treatment at baseline ( including those who were receiving a combination of two therapies ) . By the end of the study , 105 patients in the placebo group and 100 patients in the selexipag group had died from any cause . Overall , 7.1 % of patients in the placebo group and 14.3 % of patients in the selexipag group discontinued their assigned regimen prematurely because of adverse events . The most common adverse events in the selexipag group were consistent with the known side effects of prostacyclin , including headache , diarrhea , nausea , and jaw pain . CONCLUSIONS Among patients with pulmonary arterial hypertension , the risk of the primary composite end point of death or a complication related to pulmonary arterial hypertension was significantly lower with selexipag than with placebo . There was no significant difference in mortality between the two study groups . ( Funded by Actelion Pharmaceuticals ; GRIPHON Clinical Trials.gov number , NCT01106014 . ) BACKGROUND Sildenafil inhibits phosphodiesterase type 5 , an enzyme that metabolizes cyclic guanosine monophosphate , thereby enhancing the cyclic guanosine monophosphate-mediated relaxation and growth inhibition of vascular smooth-muscle cells , including those in the lung . METHODS In this double-blind , placebo-controlled study , we r and omly assigned 278 patients with symptomatic pulmonary arterial hypertension ( either idiopathic or associated with connective-tissue disease or with repaired congenital systemic-to-pulmonary shunts ) to placebo or sildenafil \n Output:\n " }, { "from": "agent", "value": "In conclusion , no significant increase in RTI had been found in PAH-specific drug therapy when compared with placebo ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To determine the impact of Maternal and Child Health ( MCH ) services on child survival in a socio-economically backward rural community . SETTING Twelve villages in Pondicherry with a population of 16,803 . DESIGN Prospect i ve study . SUBJECTS A birth cohort of 356 live births ( LB ) born between January 1st and December 31st 1988 . METHODS The live births were followed-up from birth to five years age ( 1988 - 1993 ) . The health care received by this cohort and the antenatal services received by the cohort mothers was review ed . Outcome measures related to child survival were determined and their changing trend since 1967 was examined . RESULTS Fifty-four per cent of the cohort children were from families below the poverty line . Antenatal registration and tetanus immunization coverage of the mothers of the cohort was 100 % . Immunization coverage of the cohort children was more than 98 % for BCG , DPT ( three doses ) and OPV ( three doses ) and 82 % for measles . The infant mortality rate had reduced from 201/1000 LB in 1967 to 64/1000 LB ( 95 % CI 58.9 - 68.1 ) in 1989 . The child death rate decreased from 29.4/1000 children 1 - 4 years of age ( 1970 ) to 18/1000 ( 95 % CI 13.9 - 22.1 ) in 1992 . There were no deaths due to neonatal tetanus or measles . Neonatal mortality ( 35/1000 LB ; 95 % CI 29.9 - 40.1 ) was higher than the post-neonatal mortality ( 29/1000 LB ; 95 % CI 24.1 - 33.9 ) . Fifty eight per cent of the neonatal deaths were due to non-infective causes like prematurity , birth asphyxia , birth injuries and congenital anomalies . Eighty per cent of post neonatal deaths were due to infections . Overall , the child survival index was high ( 91.27 % ; 95 % CI 88.14 - 94.26 ) . This was inspite of the low socio-economic background of the children 's families . CONCLUSIONS Good MCH services can substantially improve child survival inspite of prevailing low socio-economic situations . Inputs for neonatal care need to be strengthened to further enhance child survival To achieve the goal of validity , the r and omized clinical trial has emerged as the scientific \" gold st and ard \" for evaluating therapies in clinical medicine . Regardless of how well r and omized clinical trials are design ed , however , problems often occur during the conduct of the trials that give rise to method ologic challenges in the analysis of results . Primarily two types of problems , changes in intended treatment and the failure to ascertain the study outcomes , occur during the conduct of r and omized clinical trials . We studied the current analytic strategies that are used to deal with these problems and how the use of these analytic strategies can change the focus of the research so that the trial no longer answers the relevant question . To ensure that the right question is answered , new methods of design and analysis are required that balance the goals of validity and clinical pertinence The effects on pregnancy outcome and maternal iron status of powdered milk ( PUR ) and a milk-based fortified product ( V-N ) were compared in a group of underweight gravidas . These take-home products were distributed during regular prenatal visits . Women in the V-N group had greater weight gain ( 12.29 vs 11.31 kg , p less than 0.05 ) and mean birth weights ( 3178 vs 3105 g , p less than 0.05 ) than those in the PUR group . Values for various indicators of maternal Fe status were also higher in the V-N group . Compared with self-selected noncompliers , similar in all control variables to compliers , children of women who consumed powdered milk or the milk-based fortified product had mean birth weights that were higher by 258 and 335 g , respectively . Data indicate a beneficial effect of the fortified product on both maternal nutritional status and fetal growth To estimate the effect of maternal zinc deficiency on pregnancy outcomes , we conducted a zinc supplementation trial in an urban shantytown in Lima , Peru , a population with habitual low zinc intakes . Beginning at 10 - 24 wk gestation , 1295 mothers were r and omly assigned to receive prenatal supplements containing 60 mg iron and 250 ( g folate , with or without 15 mg zinc . Women were followed up monthly during pregnancy . At birth , newborn weight was recorded , and crownheel length , head circumference and other circumferences and skinfold thicknesses were assessed on d 1 . At delivery , 1016 remained in the study ; duration of pregnancy was known for all women , and birth weight information was available for 957 newborns . No differences were noted in duration of pregnancy ( 39.4 + /- 2.2 vs. 39 . 5 + /- 2.0 wk ) or birth weight ( 3267 + /- 461 vs. 3300 + /- 498 g ) by prenatal supplement type ( iron + folate + zinc vs. iron + folate ; P > 0.05 ) , and there were no differences in the rates of preterm ( < 37 wk ) or post-term ( > 42 wk ) delivery , low birth weight ( < 2500 g ) or high birth weight ( > 4000 g ) . Finally , there were no differences by prenatal supplement type in newborn head circumference , crownheel length , chest circumference , mid-upper arm circumference , calf circumference or skinfold thickness at any of three sites . Adjustment for covariates and confounding factors did not alter these results . Adding zinc to prenatal iron and folate tablets did not affect duration of pregnancy or size at birth in this population BACKGROUND Little is known about the benefits of prenatal multivitamin and mineral supplements in reducing low birth weight . OBJECTIVE We conducted a r and omized , double-blind clinical trial in semirural Mexico to compare the effects of multiple micronutrient ( MM ) supplements with those of iron supplements during pregnancy on birth size . DESIGN Pregnant women ( n = 873 ) were recruited before 13 wk of gestation and received supplements 6 d/wk at home , as well as routine antenatal care , until delivery . Both supplements contained 60 mg Fe , but the MM group also received 1 - 1.5 times the recommended dietary allowances of several micronutrients . RESULTS At recruitment , the women in the 2 groups were not significantly different in age , parity , economic status , height , or hemoglobin concentration but differed significantly in marital status ( 4.6 % and 2.0 % of women in the MM and iron-only groups , respectively , were single mothers ) and mean ( + /- SD ) body mass index ( in kg/m(2 ) ; 24.6 + /- 4.3 and 23.8 + /- 3.9 in the iron-only and MM groups , respectively ) . Losses to follow-up ( 25 % ) and compliance ( 95 % ) did not differ significantly between the groups . In intent-to-treat analyses ( MM group : n = 323 ; iron-only group : n = 322 ) , mean ( + /- SD ) birth weight ( 2.981 + /- 0.391 and 2.977 + /- 0.393 kg in the MM and iron-only groups , respectively ) and birth length ( 48.61 + /- 1.82 and 48.66 + /- 1.83 cm in the MM and iron-only groups , respectively ) did not differ significantly between the groups . CONCLUSION These findings suggest that MM supplementation during pregnancy does not lead to greater infant birth size than does iron-only supplementation BACKGROUND Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years . 90 % of deliveries in the poorest quintile of households happen at home . We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates . METHODS We pair-matched 42 geopolitical clusters in Makwanpur district , Nepal , selected 12 pairs r and omly , and r and omly assigned one of each pair to intervention or control . In each intervention cluster ( average population 7000 ) , a female facilitator convened nine women 's group meetings every month . The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them . We monitored birth outcomes in a cohort of 28?931 women , of whom 8 % joined the groups . The primary outcome was neonatal mortality rate . Other outcomes included stillbirths and maternal deaths , uptake of antenatal and delivery services , home care practice s , infant morbidity , and health-care seeking . Analysis was by intention to treat . The study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N31137309 . FINDINGS From 2001 to 2003 , the neonatal mortality rate was 26.2 per 1000 ( 76 deaths per 2899 livebirths ) in intervention clusters compared with 36.9 per 1000 ( 119 deaths per 3226 livebirths ) in controls ( adjusted odds ratio 0.70 [ 95 % CI 0.53 - 0.94 ] ) . Stillbirth rates were similar in both groups . The maternal mortality ratio was 69 per 100000 ( two deaths per 2899 livebirths ) in intervention clusters compared with 341 per 100000 ( 11 deaths per 3226 livebirths ) in control clusters ( 0.22 [ 0.05 - 0.90 ] ) . Women in intervention clusters were more likely to have antenatal care , institutional delivery , trained birth attendance , and hygienic care than were controls . INTERPRETATION Birth outcomes in a poor rural population improved greatly through a low cost , potentially sustainable and scalable , participatory intervention with women 's groups OBJECTIVES In their efforts to reduce maternal and neonatal morbidity and mortality , many national and international agencies make considerable investments in training traditional birth attendants ( TBAs ) . The value of TBA training is controversial , and plausible arguments are made both for and against . Numerous process evaluations are reported in the literature and the results are mixed , though generally positive . Outcome evaluations , however , are scarce . This article describes an outcome evaluation of TBA training conducted in two districts of Brong-Ahafo Region , Ghana , during 1996 . DESIGN AND METHODS Data from a r and om sample survey of 1961 clients of TBAs were subjected to logistic regression modelling to determine the effect of training on maternal outcomes , controlling for other independent variables . RESULTS Of eight outcomes modelled , three were associated with training and five were not . Three additional outcomes were not modelled , primarily due to low prevalence . CONCLUSIONS Despite some inherent design limitations , this study found that the evidence for a beneficial impact of TBA training was not compelling . Training sponsors should consider alternative health investments and , where TBA training remains the intervention of choice , be realistic about expectations of impact BACKGROUND No satisfactory strategy for reducing high child mortality from malaria has yet been established in tropical Africa . We compared the effect on under-5 mortality of teaching mothers to promptly provide antimalarials to their sick children at home , with the present community health worker approach . METHODS Of 37 tabias ( cluster of villages ) in two districts with hyperendemic to holoendemic malaria , tabias reported to have the highest malaria morbidity were selected . A census was done which included a maternity history to determine under-5 mortality . Tabias ( population 70,506 ) were paired according to under-5 mortality rates . One tabia from each pair was allocated by r and om number to an intervention group and the other was allocated to the control group . In the intervention tabias , mother coordinators were trained to teach other local mothers to recognise symptoms of malaria in their children and to promptly give chloroquine . In both intervention and control tabias , all births and deaths of under-5s were recorded monthly . FINDINGS From January to December 1997 , 190 of 6383 ( 29.8 per 1000 ) children under-5 died in the intervention tabias compared with 366 of 7294 ( 50.2 per 1000 ) in the control tabias . Under-5 mortality was reduced by 40 % in the intervention localities ( 95 % CI from 29.2 - 50.6 ; paired t test , p<0.003 ) . For every third child who died , a structured verbal autopsy was undertaken to ascribe cause of mortality as consistent with malaria or possible malaria , or not consistent with malaria . Of the 190 verbal autopsies , 13 ( 19 % ) of 70 in the intervention tabias were consistent with possible malaria compared with 68 ( 57 % ) of 120 in the control tabias . INTERPRETATION A major reduction in under-5 mortality can be achieved in holoendemic malaria areas through training local mother coordinators to teach mothers to give under-5 children antimalarial drugs BACKG \n Output:\n " }, { "from": "agent", "value": "Interventions appeared largely bundled out of convenience or funding requirements , rather than based on anticipated synergistic effects , like service delivery mode or cost-effectiveness ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: AIM AND OBJECTIVES The aim of the research is to determine the effect of cold application on the pain owing to chest tube removal for patients with single pleural chest tube . BACKGROUND Removal of chest tubes causes patients to feel pain and interventions used for reducing the pain owing to the removal of chest tubes are not sufficient . DESIGN Controlled clinical trial with repeated measures . METHODS This study was conducted with 140 patients , of whom 70 patients were in the experimental group and 70 patients were in the control group , in a thoracic hospital in Turkey . Data were collected using a data collection form consisting of patients ' demographic and health history and Visual Analogue Scale . Cold was applied to patients in the experimental group prior to chest tube removal . In the experimental group , skin temperature and pain intensity was measured for each patient at four time points . In the control group , pain intensity was evaluated for each patient at three time points . Data were evaluated using Chi-square and Repeated Measurements two-way anova tests . RESULTS The Visual Analogue Scale score was measured immediately after the chest tube removal in the experimental group was 3·85 , compared with 5·60 in the control group . There were significant differences on pain with cold application between the two groups prior and after the intervention . Age , gender , the number of days the chest tube was inserted and the chest tube insertion indication had no effect on the pain owing to chest tube removal . CONCLUSION Cold application is effective in reducing the pain owing to chest tube removal . RELEVANCE TO CLINICAL PRACTICE Cold application was recommended prior to chest tube removal to reduce the pain owing to removal of chest tube The aim of this study was to investigate the effect of Reiki on pain , anxiety , and hemodynamic parameters on postoperative days 1 and 2 in patients who had undergone cesarean delivery . The design of this study was a r and omized , controlled clinical trial . The study took place between February and July 2011 in the Obstetrical Unit at Odemis Public Hospital in Izmir , Turkey . Ninety patients equalized by age and number of births were r and omly assigned to either a Reiki group or a control group ( a rest without treatment ) . Treatment applied to both groups in the first 24 and 48 hours after delivery for a total of 30 minutes to 10 identified regions of the body for 3 minutes each . Reiki was applied for 2 days once a day ( in the first 24 and 48 hours ) within 4 - 8 hours of the administration of st and ard analgesic , which was administered intravenously by a nurse . A visual analog scale and the State Anxiety Inventory were used to measure pain and anxiety . Hemodynamic parameters , including blood pressure ( systolic and diastolic ) , pulse and breathing rates , and analgesic requirements also were recorded . Statistically significant differences in pain intensity ( p = .000 ) , anxiety value ( p = .000 ) , and breathing rate ( p = .000 ) measured over time were found between the two groups . There was a statistically significant difference between the two groups in the time ( p = .000 ) and number ( p = .000 ) of analgesics needed after Reiki application and a rest without treatment . Results showed that Reiki application reduced the intensity of pain , the value of anxiety , and the breathing rate , as well as the need for and number of analgesics . However , it did not affect blood pressure or pulse rate . Reiki application as a nursing intervention is recommended as a pain and anxiety-relieving method in women after cesarean delivery The aim of this r and omized controlled trial was to determine the effect of jaw relaxation , music and the combination of relaxation and music on postoperative pain after major abdominal surgery during ambulation and rest on postoperative days 1 and 2 . Opioid medication provided for pain , following abdominal surgery , does not always give sufficient relief and can cause undesired side effects . Thus , additional interventions such as music and relaxation may provide more complete relief . Previous studies have found mixed results due to small sample sizes and other method ological problems . In a rigorous experimental design , 500 subjects aged 18 - 70 in five Midwestern hospitals were r and omly assigned by minimization to a relaxation , music , relaxation plus music , or control group . Interventions were taught preoperatively and tested postoperatively . The same amount of time was spent with subjects in the control group . Pain was measured with the visual analogue sensation and distress of pain scales . Demographic and surgical variables , and milligrams of parenteral or oral opioids in effect at the time of testing were not significantly different between the groups , nor did they correlate with pain scores . Controlling for pretest sensation and distress , orthogonal a priori contrasts and multivariate analysis of covariance indicated that the three treatment groups had significantly less pain than the controls , ( P = 0.028 - 0.000 ) which was confirmed by the univariate analysis of covariance ( P = 0.018 - 0.000 ) . Post hoc multivariate analysis revealed that the combination group had significantly less sensation and distress of pain than the control group on all post-tests ( P = 0.035 - 0.000 ) , and the relaxation and music groups had significantly less on all tests ( P = 0.022 - 0.000 ) except after ambulation . At post ambulation those using relaxation did not have significantly less pain than the controls on both days and those using music did not on day 1 , although there were some univariate effects . A corresponding significant decrease in mastery of the interventions from pre to post ambulation suggests the need for reminders to focus on the intervention during this increased activity . Physicians and nurses preparing patients for surgery and caring for them afterward , should encourage patients to use relaxation and music as adjuvants to medication for postoperative pain The purpose of this study was to examine the effects of relaxation techniques and back massage on postoperative pain , anxiety , and vital signs on postoperative days 1 - 3 in patients who had undergone total hip or knee arthroplasty ( THA , TKA ) . Sixty patients having a THA or TKA were r and omly assigned to either a experimental group or a control group . The McGill Pain Question naire Short Form ( MPQ-SF ) and State Anxiety Inventory ( SAI ) were used to measure pain and anxiety , respectively . Vital signs , including blood pressure ( systolic and diastolic ) , pulse , and respiratory rate , were also obtained . Statistically significant differences in pain intensity ( F = 14.50 ; p = .000 ) , anxiety level ( F = 19.13 ; p = .000 ) , and vital signs ( F = 169.61 , 9.14 , 14.23 , 65.64 ; p = .000 ) measured over time were found between the experimental and the control group . Results of this research provide evidence to support the use of relaxation techniques and back massage at bed rest times of patients to decrease pain and anxiety . The interventions helped them to forget about their pain for a while and improved their anxiety state . After an evaluation of the conclusions , use of these interventions should be implemented by nurses into routine plans of care for patients OBJECTIVES In surgery clinics , postoperative pain is a common occurrence and care is needed in its treatment . One form of treatment is various acupuncture techniques . This study investigated the effect of acupuncture on postoperative analgesia in patients undergoing laparoscopic cholecystectomy . METHODS A total of 59 patients undergoing laparoscopic cholecystectomy were included in the study ; 31 comprised the acupuncture group ( Group A ) , and 29 constituted the control group ( group C ) . All patients underwent st and ard anesthesia procedures . Patient-controlled analgesia with tramadol was administered postoperatively . Patients ' postoperative pain scores , results of the satisfaction question naire and amounts of tramadol used were recorded . Postoperative 0 , 1st , 2nd , 6th , 12th and 18th hour controls were performed . RESULTS A comparison of the groups showed Group A pain scores to be significantly lower statistically than those of Group C at all postoperative controls . There was no statistically significant difference for postoperative analgesic consumption and satisfaction level between the groups . CONCLUSION Despite detection of a reduction in postoperative pain scores , the application of acupuncture did not cause any change in the consumption of tramadol The aim of this study was to investigate the effect of cold application on pain and anxiety during chest tube removal ( CTR ) in patients who had undergone cardiac surgery . A single-blinded r and omized design was used in this study . Ninety patients aged 18 - 74 years , hospitalized in the intensive care unit ( ICU ) , who had a chest tube for a duration of at least 24 hours were used for this convenience sample . The application of cold , placebo , or control therapies was r and omized into three different groups . Sixty minutes before CTR was scheduled , an ICU nurse administered 10mg/kg paracetamol intravenously to all study subjects . Cold and warm packs covered with gauze dressing were applied to the area surrounding the chest tubes for 20 minutes . Pain intensity , pain quality and situational anxiety for CTR were measured . Variance analysis and the latent growth model were used in the analysis of the data . Patients in the cold group had significantly lower pain intensity than the placebo group . The perception of pain intensity measured by visual analog scores of patients in the cold group showed the least variation . There was no statistically significant difference in McGill Melzack Pain Question naire scores or in change of anxiety level between the three groups . The application of cold prolonged the length of time until analgesics were needed after CTR . Results showed that cold application reduced patients ' intensity of pain due to CTR but did not affect anxiety levels or the type of pain . Cold application is recommended as a pain-relieving technique during CTR The aim of this study was to investigate the effect of listening to personal choice of music on self-report of pain intensity and the physiologic parameters in patients who have undergone open heart surgery . The study design was quasiexperimental . Patients were selected through convenience sampling in the Cardiovascular Surgery Intensive Care Unit at a university hospital . The study was conducted with a total of 87 patients who underwent open heart surgery : 44 in the music group , 43 in the control group , ages between 18 and 78 years . Through pretest-posttest design , postoperative first-day data were collected . First , physiologic parameters ( blood pressure , heart rate , oxygen saturation , and respiratory rate ) were recorded and a unidimensional verbal pain intensity scale applied to all participants . Later , the control group had a rest in their beds while the music group listened to their choice of music for 30 minutes . Physiologic data were then collected and the pain intensity scale applied once more . In the music group , there was a statistically significant increase in oxygen saturation ( p = .001 ) and a lower pain score ( p = .001 ) than in the control group . There was no difference between the groups in the other physiologic parameters . Results of this research provide evidence to support the use of music . Music might be a simple , safe , and effective method of reducing potentially harmful physiologic responses arising from pain in patients after open heart surgery \n Output:\n " }, { "from": "agent", "value": "Non-pharmacologic pain management is an effective way to reduce pain severity and it can be independently used by nurses .\nResearch ers of dissertations often choose non-pharmacologic practice s that have no side effects , have minimum risk , are not detrimental to patients , are easy to administer , and are cost-efficient ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: 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 In 2007 , the International Agency for Research on Cancer declared shift work that involved circadian disruption to be a \" probable \" carcinogen ( group 2A ) , noting that human evidence was limited . Using data from 2 prospect i ve cohort studies , the Nurses ' Health Study ( 1988 - 2012 ; n = 78,516 ) and Nurses ' Health Study II ( 1989 - 2013 ; n = 114,559 ) , we examined associations between rotating night-shift work and breast cancer risk . In the 2 cohorts , there were a total of 9,541 incident invasive breast malignancies and 24 years of follow-up . In the Nurses ' Health Study , women with 30 years or more of shift work did not have a higher risk of breast cancer ( hazard ratio ( HR ) = 0.95 , 95 % confidence interval ( 95 % CI ) : 0.77 , 1.17 ; P for trend = 0.63 ) compared with those who never did shift work , although follow-up occurred primarily after retirement from shift work . Among participants in the Nurses ' Health Study II , who were younger than participants in the other cohort , the risk of breast cancer was significantly higher in women with 20 years or more of shift work at baseline , reflecting young-adult exposure ( HR = 2.15 , 95 % CI : 1.23 , 3.73 ; P for trend = 0.23 ) , and was marginally significantly higher for women with 20 years or more of cumulative shift work when we used up date d exposure information ( HR = 1.40 , 95 % CI : 1.00 , 1.97 ; P for trend = 0.74 ) . In conclusion , long-term rotating night-shift work was associated with a higher risk of breast cancer , particularly among women who performed shift work during young adulthood . Further studies should explore the role of shift work timing on breast cancer risk CONTEXT Neuroendocrine and immune stresses imposed by chronic sleep restriction are known to be involved in the harmful cardiovascular effects associated with poor sleep . OBJECTIVES Despite a well-known beneficial effect of napping on alertness , its effects on neuroendocrine stress and immune responses after sleep restriction are largely unknown . DESIGN This study was a strictly controlled ( sleep-wake status , light environment , caloric intake ) , crossover , r and omized design in continuously polysomnography-monitored subjects . SETTING The study was conducted in a laboratory-based study . PARTICIPANTS The subjects were 11 healthy young men . INTERVENTION We investigated the effects on neuroendocrine and immune biomarkers of a night of sleep restricted to 2 h followed by a day without naps or with 30 minute morning and afternoon naps , both conditions followed by an ad libitum recovery night starting at 20:00 . MAIN OUTCOME MEASURES Salivary interleukin-6 and urinary catecholamines were assessed throughout the daytime study periods . RESULTS The increase in norepinephrine values seen at the end of the afternoon after the sleep-restricted night was not present when the subjects had the opportunity to take naps . Interleukin-6 changes observed after sleep deprivation were also normalized after napping . During the recovery day in the no-nap condition , there were increased levels of afternoon epinephrine and dopamine , which was not the case in the nap condition . A recovery night after napping was associated with a reduced amount of slow-wave sleep compared to after the no-nap condition . CONCLUSIONS Our data suggest that napping has stress-releasing and immune effects . Napping could be easily applied in real setting s as a countermeasure to the detrimental health consequences of sleep debt 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 Background Shift work has been hypothesized as a risk factor for obesity . In this study , we investigated the association between current shift work and body mass index ( BMI ) among female nurses in Korea . The relationship between duration of shift work and BMI of the participants was also evaluated . Methods This cross-sectional survey evaluated participants in the Korean Nurses ’ Survey , conducted from October to December 2011 , using web-based self-administered question naires . A total of 9,989 nurses were included among 10,000 who registered on the survey web site ( 5,287 shift workers and 4,702 non-shift workers ) . Current shift workers were divided into tertiles of shift work duration ( 0.08–3.00 years , n = 1,732 ; 3.08–6.75 years , n = 1,731 ; and 6.83–38.00 years , n = 1,686 ) . The BMI thresholds of overweight and obesity were ≥23 kg/m2 and ≥25 kg/m2 , respectively . Data were analyzed using SPSS software . Results Mean participant age was 33.2 ± 8.6 years and the mean BMI was 20.9 ± 2.5 kg/m2 . There were statistically significant differences in current smoking status , regular drinking habit , dietary habits , regular exercise , sleep problems and self-perceived health status according to duration of shift work . The overall prevalence of overweight/obesity ( 18.6 % ) and obesity ( 7.4 % ) increased significantly as shift work duration increased from the lowest to highest tertile ( P for trend < 0.001 ) . Multivariate logistic regression analysis revealed no association between current shift work and BMI . However , after adjusting for potential confounders , the participants with the longest duration of shift work were 1.63 ( 95 % CI , 1.22–2.17 ) times more likely to be overweight or obese than those with the shortest duration . There was a significant positive association between obesity and shift work duration in the unadjusted analysis ; however , it was attenuated and no longer significant in the multivariate model . Conclusions The duration of shift work was positively associated with prevalence of overweight/obesity in nurses in Korea . Although these findings need to be confirmed in prospect i ve studies , they suggest that special attention should be paid to female nurses with a long duration of shift work STUDY OBJECTIVES To assess sleep inertia following 10-min and 30-min naps during a simulated night shift . METHODS Thirty-one healthy adults ( aged 21 - 35 y ; 18 females ) participated in a 3-day laboratory study that included one baseline ( BL ) sleep ( 22:00 - 07:00 ) and one experimental night involving r and omization to either : total sleep deprivation ( NO-NAP ) , a 10-min nap ( 10-NAP ) or a 30-min nap ( 30-NAP ) . Nap opportunities ended at 04:00 . A 3-min psychomotor vigilance task ( PVT-B ) , digit-symbol substitution task ( DSST ) , fatigue scale , sleepiness scale , and self-rated performance scale were undertaken pre-nap ( 03:00 ) and at 2 , 17 , 32 , and 47 min post-nap . RESULTS The 30-NAP ( 14.7 ± 5.7 min ) had more slow wave sleep than the 10-NAP ( 0.8 ± 1.5 min ; P < 0.001 ) condition . In the NO-NAP condition , PVT-B performance was worse than pre-nap ( 4.6 ± 0.3 1/sec ) at 47 min post-nap ( 4.1 ± 0.4 1/sec ; P < 0.001 ) . There was no change across time in the 10-NAP condition . In the 30-NAP condition , performance immediately deteriorated from pre-nap ( 4.3 ± 0.3 1/sec ) and was still worse at 47 min post-nap ( 4.0 ± 0.5 1/sec ; P < 0.015 ) . DSST performance deteriorated in the NO-NAP ( worse than pre-nap from 17 to 47 min ; P < 0.008 ) , did not change in the 10-NAP , and was impaired 2 min post-nap in the 30-NAP condition ( P = 0.028 ) . All conditions self-rated performance as better than pre-nap for all post-nap test points ( P < 0.001 ) . CONCLUSIONS This study is the first to show that a 10-min ( but not a 30-min ) nighttime nap had minimal sleep inertia and helped to mitigate short-term performance impairment during a simulated night shift . Self-rated performance did not reflect objective performance following a nap OBJECTIVES To evaluate the effectiveness of a broad , literature -based night shiftwork intervention for enhancement of emergency physicians ' ( EPs ' ) adaptation to night rotations . METHODS A prospect i ve , double-blind , active placebo-controlled study was conducted on 6 attending physicians in a university hospital ED . Three data sets were collected under the following conditions : baseline , after active placebo intervention , and after experimental intervention . In each condition , data were collected when the physicians worked both night and day shifts . Measurements included ambulatory polysomnographic recordings of the main sleep periods , objective performance tests administered several times during the subjects ' shifts , and daily subjective ratings of the subjects ' sleep , moods , and intervention use . RESULTS The subjects slept an average of 5 hr 42 min across all conditions . After night shifts , the subjects slept significantly less than they did after day shifts ( 5 hr 13 min vs 6 hr 20 min ; p < 0.05 ) . The physicians ' vigilance reaction times and times for intubation of a mannequin were significantly slower during night shifts than they were during day shifts ( p = 0.007 and p < 0.04 , respectively ) , but performances on ECG analysis did not significantly differ between night and day shifts . Mood ratings were significantly more negative during night shifts than they were during day shifts ( more sluggish p < 0.04 , less motivated p < 0.03 , and less clear thinking p < 0.04 ) . The strategies in the experimental intervention were used 85 % of the time according to logbook entries . The experimental and active placebo interventions did not significantly improve the physician 's performance , or mood on the night shift , although the subjects slept more after both interventions . CONCLUSIONS Although the experimental intervention was successfully implemented , it failed to significantly improve attending physicians ' sleep , performance , or mood on night shifts . A decrease in speed of intubation , vigilance reaction times , and subjective alertness was evident each time the physicians rotated through the night shift . These findings plus the limited sleep across all conditions and shifts suggest that circadian-mediated disruptions of waking neurobehavioral functions and sleep deprivation are problems in EPs IMPORTANCE Prospect i ve studies linking shift work to coronary heart disease ( CHD ) have been inconsistent and limited by short follow-up . OBJECTIVE To determine whether rotating night shift work is associated with CHD risk . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 189,158 initially healthy women followed up over 24 years in the Nurses ' Health Studies ( NHS [ 1988 - 2012 ] : N = 73,623 and NHS2 [ 1989 - 2013 ] : N = 115,535 ) . EXPOSURES Lifetime history of rotating night shift work ( ≥3 night shifts per month in addition to day and evening shifts ) at baseline ( up date d every 2 to 4 years in the NHS2 ) . MAIN OUTCOMES AND MEASURES Incident CHD ; ie , nonfatal myocardial infa rct ion , CHD death , angiogram-confirmed angina pectoris , coronary artery bypass graft surgery , stents , and angioplasty . RESULTS During follow-up , 7303 incident CHD cases occurred in the NHS ( mean age at baseline , 54.5 years ) and 3519 in the NHS2 ( mean age , 34.8 years ) . In multivariable-adjusted Cox proportional hazards models , increasing years of baseline rotating night shift work was associated with significantly higher CHD risk in both cohorts . In the NHS , the association between duration of shift work and CHD was stronger in the first half of follow-up than in the second half ( P=.02 for interaction ) , suggesting waning risk after cessation of shift work . Longer time since quitting shift work was associated with decreased CHD risk among ever shift workers in the NHS2 ( P<.00 \n Output:\n " }, { "from": "agent", "value": "Many nurses experienced napping during their night-shift although no clear policy emerged .\nNapping is beneficial to the well-being of nurses and could improve their psychomotor vigilance and performance .\nThe evidence on reducing sleepiness and fatigue was also insufficient and napping in nursing still faces challenges .\nAlthough research on this topic has just started , napping during night-shift is beneficial to nurses ' health and performance ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Research suggests that patients with cancer , particularly in the palliative care setting , are increasingly using aromatherapy and massage . There is good evidence that these therapies may be helpful for anxiety reduction for short periods , but few studies have looked at the longer term effects . This study was design ed to compare the effects of four-week courses of aromatherapy massage and massage alone on physical and psychological symptoms in patients with advanced cancer . Forty-two patients were r and omly allocated to receive weekly massages with lavender essential oil and an inert carrier oil ( aromatherapy group ) , an inert carrier oil only ( massage group ) or no intervention . Outcome measures included a Visual Analogue Scale ( VAS ) of pain intensity , the Verran and Snyder-Halpern ( VSH ) sleep scale , the Hospital Anxiety and Depression ( HAD ) scale and the Rotterdam Symptom Checklist ( RSCL ) . We were unable to demonstrate any significant long-term benefits of aromatherapy or massage in terms of improving pain control , anxiety or quality of life . However , sleep scores improved significantly in both the massage and the combined massage ( aromatherapy and massage ) groups . There were also statistically significant reductions in depression scores in the massage group . In this study of patients with advanced cancer , the addition of lavender essential oil did not appear to increase the beneficial effects of massage . Our results do suggest , however , that patients with high levels of psychological distress respond best to these therapies Results of the pilot study of the four counties r and omised controlled trial to evaluate the effectiveness of aromatherapy massage with 1 % Santalum album ( S and alwood ) ( group A ) when compared with massage with Sweet Almond Carrier oil , ( group B ) or S and alwood oil via an aromastone ( group C ) , in reducing levels of anxiety in palliative care . The aims of the pilot study were to evaluate the effectiveness of aromatherapy in reducing anxiety in patients receiving palliative care in four counties . The primary end points of the research were to report a statistically significant difference in anxiety scores between experimental group ( B ) and comparison groups ( A and C ) and to influence the integration of aromatherapy into all aspects of palliative care . The limited data of the pilot study ( N=34 ) tested the logistics of the research , particularly the 25 % attrition rate and the robustness of the data collection tools . The results were not substantial enough to generate coherent statistics . Therefore no assumptions could be drawn from these results due to the inconsistencies that were bound to occur in such a small sample . However , the results do seem to support the notion that S and alwood oil is effective in reducing anxiety The goal of this study was to investigate the impact of the essential oils of orange and lavender on anxiety , mood , alertness and calmness in dental patients . Two hundred patients between the ages of 18 and 77 years ( half women , half men ) were assigned to one of four independent groups . While waiting for dental procedures patients were either stimulated with ambient odor of orange or ambient odor of lavender . These conditions were compared to a music condition and a control condition ( no odor , no music ) . Anxiety , mood , alertness and calmness were assessed while patients waited for dental treatment . Statistical analyses revealed that compared to control condition both ambient odors of orange and lavender reduced anxiety and improved mood in patients waiting for dental treatment . These findings support the previous opinion that odors are capable of altering emotional states and may indicate that the use of odors is helpful in reducing anxiety in dental patients CONTEXT Interest in the use of alternative therapies to reduce anxiety in patients undergoing medical interventions is increasing . We sought to assess the effectiveness of aromatherapy involving essential oils in reducing preoperative anxiety in women undergoing abortions . SETTING An urban , free-st and ing abortion clinic in Vancouver , BC . PATIENTS 66 women waiting for surgical abortions . DESIGN A double blind , r and omized trial . INTERVENTION Ten minutes spent sniffing a numbered container with either a mixture of the essential oils vetivert , bergamot , and geranium ( treatment arm ) or a hair conditioner ( placebo ) . OUTCOME MEASURES Anxiety was measured before and after the intervention by using a verbal anxiety scale from 0 to 10 . RESULTS The anxiety score was reduced by 1.0 point ( 5.0 to 4.0 ) in the aromatherapy group and by 1.1 points ( 6.1 to 5.0 ) in the placebo group ( P = 0.71 ) . The 95 % CI on the 0.1 greater decrease in anxiety for the placebo group extends from 0.55 less ( favors aromatherapy ) to 0.75 greater ( favors placebo ) . CONCLUSION Aromatherapy involving essential oils is no more effective than having patients sniff other pleasant odors in reducing preprocedure anxiety OBJECTIVE Melissa officinalis ( lemon balm ) and Valeriana officinalis ( valerian ) have been used both traditionally and contemporaneously as mild sedatives , anxiolytics and hypnotics . Recent research has suggested that both may attenuate laboratory induced stress . As the two herbs are most often sold in combination with each other the current study assessed the anxiolytic properties of such a combination during laboratory-induced stress . METHODS In this double-blind , placebo-controlled , r and omized , balanced cross-over experiment , 24 healthy volunteers received three separate single doses ( 600 mg , 1200 mg , 1800 mg ) of a st and ardized product containing M. officinalis and V. officinalis extracts , plus a placebo , on separate days separated by a 7 day wash out period . Modulation of mood and anxiety were assessed during pre-dose and 1 h , 3 h and 6 h post-dose completions of a 20 min version of the Defined Intensity Stressor Simulation ( DISS ) battery . Cognitive performance on the four concurrent tasks of the battery was also assessed . RESULTS The results showed that the 600 mg dose of the combination ameliorated the negative effects of the DISS on ratings of anxiety . However , the highest dose ( 1800 mg ) showed an increase in anxiety that was less marked but which reached significance during one testing session . In addition , all three doses led to decrements in performance on the Stroop task module within the battery , and the two lower doses led to decrements on the overall score generated on the DISS battery . CONCLUSIONS These results suggest that a combination of Melissa officinalis and Valeriana officinalis possesses anxiolytic properties that deserve further investigation This study examined the effect of aromatherapy-massage in healthy postpartum mothers . A quasi-experimental between-groups design was used . Mothers who received aromatherapy-massage were compared with a control group who received st and ard postpartum care . Thirty-six healthy , first-time mothers with vaginal delivery of a full-term , healthy infant participated in this study . Sixteen mothers received a 30-minute aromatherapy-massage on the second postpartum day ; 20 mothers were in the control group . All mothers completed the following four st and ardized question naires before and after the intervention : 1 ) Maternity Blues Scale ; 2 ) State-Trait Anxiety Inventory ; 3 ) Profile of Mood States ( POMS ) ; and 4 ) Feeling toward Baby Scale . In the aromatherapy-massage group , posttreatment scores significantly decreased for the Maternity Blues Scale , the State-Anxiety Inventory , and all but one of the Profile of Mood States subscales . Posttreatment scores in the intervention group significantly increased in Profile of Mood States-Vigor subscale and the Approach Feeling toward Baby subscale . Scores in the intervention group significantly decreased in Conflict Index of Avoidance/Approach Feeling toward Baby subscale . Our results suggest that aromatherapy-massage might be an effective intervention for postpartum mothers to improve physical and mental status and to facilitate mother-infant interaction PURPOSE To test the effectiveness of supplementing usual supportive care with aromatherapy massage in the management of anxiety and depression in cancer patients through a pragmatic two-arm r and omized controlled trial in four United Kingdom cancer centers and a hospice . PATIENTS AND METHODS Two hundred eighty-eight cancer patients , referred to complementary therapy services with clinical anxiety and /or depression , were allocated r and omly to a course of aromatherapy massage or usual supportive care alone . RESULTS Patients who received aromatherapy massage had no significant improvement in clinical anxiety and /or depression compared with those receiving usual care at 10 weeks postr and omization ( odds ratio [ OR ] , 1.3 ; 95 % CI , 0.9 to 1.7 ; P = .1 ) , but did at 6 weeks postr and omization ( OR , 1.4 ; 95 % CI , 1.1 to 1.9 ; P = .01 ) . Patients receiving aromatherapy massage also described greater improvement in self-reported anxiety at both 6 and 10 weeks postr and omization ( OR , 3.4 ; 95 % CI , 0.2 to 6.7 ; P = .04 and OR , 3.4 ; 95 % CI , 0.2 to 6.6 ; P = .04 ) , respectively . CONCLUSION Aromatherapy massage does not appear to confer benefit on cancer patients ' anxiety and /or depression in the long-term , but is associated with clinical ly important benefit up to 2 weeks after the intervention The purpose of this study was to assess the effects of water , lavender , or rosemary scent on physiology and mood state following an anxiety-provoking task . The nonsmoking participants , ages 18–30 years , included 42 women and 31 men who reported demographic information and measures of external temperature and heart rate were taken prior to introduction of an anxiety-eliciting task and exposure to lavender , rosemary , or water scents . Following the task , participants completed the Profile of Mood States to assess mood , and temperature and heart rate were reassessed . Participants rated the pleasantness of the scent received . When pleasantness ratings of scent were covaried , physiological changes in temperature and heart rate did not differ based on scent exposure , but mood ratings differed by scent condition . Participants in the rosemary condition scored higher on measures of tension – anxiety and confusion – bewilderment relative to the lavender and control conditions . The lavender and control conditions showed higher mean vigor – activity ratings relative to the rosemary group , while both rosemary and lavender scents were associated with lower mean ratings on the fatigue – inertia subscale , relative to the control group . These results suggest that , when individual perception of scent pleasantness is controlled , scent has the potential to moderate different aspects of mood following an anxiety-provoking task OBJECTIVE The objective is to identify whether single 20 min massage sessions were safe and effective in reducing stress levels of isolated haematological oncology patients . DESIGN Based on a r and omised controlled trial , 39 patients were r and omised to aromatherapy , massage or rest ( control ) arm . MEASURES The measures were serum cortisol and prolactin levels , quality of life ( EORTC QLQ-C30 ) and semi-structured interviews . Primary outcome measure was the fall in serum cortisol levels . RESULTS A significant difference was seen between arms in cortisol ( P=0.002 ) and prolactin ( p=0.031 ) levels from baseline to 30 min post-session . Aromatherapy and massage arms showed a significantly greater drop in cortisol than the rest arm . Only the massage arm had a significantly greater reduction in prolactin then the rest arm . The EORTC QLQ-C30 showed a significant reduction in ' need for rest ' for patients in both experimental arms compared with the control arm , whereas the semi-structured interviews identified a universal feeling of relaxation in patients in the experimental arms . CONCLUSION This pilot study demonstrated that in isolated haematological oncology patients , a significant reduction in cortisol could be safely achieved through massage , with associated improvement in psychological well-being . The implication s are discussed The purpose of this study was to evaluate the use of aromatherapy to reduce anxiety prior to a scheduled colonoscopy or esophagogastroduodenoscopy . A controlled , prospect i ve study was done on a convenience sample of 118 patients . The “ state ” component of the State Trait Anxiety Inventory ( STAI ) was used to evaluate patients ' anxiety levels pre- and postaromatherapy . The control group was given an inert oil ( placebo ) for inhalation , and the experimental group was given the essential oil , lavender , for inhalation . The STAI state anxiety raw score revealed that patients were at the 99th ( women ) and 96th ( men ) percentiles for anxiety . The intervention group and the control group had similar levels of state anxiety prior to the beginning of the study ( t[116 ] = .47 , p = .64 ) . There was no difference in state anxiety levels between pre- and postplacebo inhalation in the control group ( t[112 ] = .48 , p = .63 ) . There was no statistical difference in state anxiety levels between pre- and postlavender inhalation in the experimental group ( t[120 ] = .73 , p = .47 ) . Although this study did not show aromatherapy to be effective based on statistical analysis , patients did generally report the lavender scent to be pleasant . Lavender is an inexpensive and popular technique for relaxation that can be offered to patients as an opportunity to promote preprocedural stress reduction in a hospital setting Benzodiazepines remain widely used for the treatment of anxiety disorders despite prominent , often limiting side effects including sedation , muscle relaxation , and ataxia . A compound producing a robust anxiolytic action comparable to benzodiazepines , but lacking these limiting side effects at therapeutic doses ( an anxioselective agent ) , would represent an important advance in the treatment of generalized anxiety disorder , and perhaps other anxiety disorders . Here we report that the pyrazolo[1,5 \n Output:\n " }, { "from": "agent", "value": "Most of the studies indicated positive effects to quell anxiety .\nIt is recommended that aromatherapy could be applied as a complementary therapy for people with anxiety symptoms ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Objective : For patients in intensive care units , sepsis is a common and potentially deadly complication and prompt initiation of appropriate antimicrobial therapy improves prognosis . The objective of this trial was to determine whether a strategy of antimicrobial spectrum escalation , guided by daily measurements of the biomarker procalcitonin , could reduce the time to appropriate therapy , thus improving survival . Design : R and omized controlled open-label trial . Setting : Nine multidisciplinary intensive care units across Denmark . Patients : A total of 1,200 critically ill patients were included after meeting the following eligibility requirements : expected intensive care unit stay of ≥24 hrs , nonpregnant , judged to not be harmed by blood sampling , bilirubin < 40 mg/dL , and triglycerides < 1000 mg/dL ( not suspensive ) . Interventions : Patients were r and omized either to the “ st and ard-of-care-only arm , ” receiving treatment according to the current international guidelines and blinded to procalcitonin levels , or to the “ procalcitonin arm , ” in which current guidelines were supplemented with a drug-escalation algorithm and intensified diagnostics based on daily procalcitonin measurements . Measurements and Main Results : The primary end point was death from any cause at day 28 ; this occurred for 31.5 % ( 190 of 604 ) patients in the procalcitonin arm and for 32.0 % ( 191 of 596 ) patients in the st and ard-of-care-only arm ( absolute risk reduction , 0.6 % ; 95 % confidence interval [ CI ] −4.7 % to 5.9 % ) . Length of stay in the intensive care unit was increased by one day ( p = .004 ) in the procalcitonin arm , the rate of mechanical ventilation per day in the intensive care unit increased 4.9 % ( 95 % CI , 3.0–6.7 % ) , and the relative risk of days with estimated glomerular filtration rate < 60 mL/min/1.73 m2 was 1.21 ( 95 % CI , 1.15–1.27 ) . Conclusions : Procalcitonin-guided antimicrobial escalation in the intensive care unit did not improve survival and did lead to organ-related harm and prolonged admission to the intensive care unit . The procalcitonin strategy like the one used in this trial can not be recommended IMPORTANCE Sepsis is considered to induce immune suppression , leading to increased susceptibility to secondary infections with associated late mortality . OBJECTIVE To determine the clinical and host genomic characteristics , incidence , and attributable mortality of intensive care unit (ICU)-acquired infections in patients admitted to the ICU with or without sepsis . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve observational study comprising consecutive admissions of more than 48 hours in 2 ICUs in the Netherl and s from January 2011 to July 2013 stratified according to admission diagnosis ( sepsis or noninfectious ) . MAIN OUTCOMES AND MEASURES The primary outcome was ICU-acquired infection ( onset > 48 hours ) . Attributable mortality risk ( fraction of mortality that can be prevented by elimination of the risk factor , acquired infection ) was determined using time-to-event models accounting for competing risk . In a subset of sepsis admissions ( n = 461 ) , blood gene expression ( whole-genome transcriptome in leukocytes ) was analyzed at baseline and at onset of ICU-acquired infectious ( n = 19 ) and noninfectious ( n = 9 ) events . RESULTS The primary cohort included 1719 sepsis admissions ( 1504 patients ; median age , 62 years ; interquartile range [ IQR ] , 51 - 71 years ] ; 924 men [ 61.4 % ] ) . A comparative cohort included 1921 admissions ( 1825 patients , median age , 62 years ; IQR , 49 - 71 years ; 1128 men [ 61.8 % ] in whom infection was not present in the first 48 hours . Intensive care unit-acquired infections occurred in 13.5 % of sepsis ICU admissions ( n = 232 ) and 15.1 % of nonsepsis ICU admissions ( n = 291 ) . Patients with sepsis who developed an ICU-acquired infection had higher disease severity scores on admission than patients with sepsis who did not develop an ICU-acquired infection ( Acute Physiology and Chronic Health Evaluation IV [ APACHE IV ] median score , 90 [ IQR , 72 - 107 ] vs 79 [ IQR , 62 - 98 ] ; P < .001 ) and throughout their ICU stay but did not have differences in baseline gene expression . The population attributable mortality fraction of ICU-acquired infections in patients with sepsis was 10.9 % ( 95 % CI , 0.9%-20.6 % ) by day 60 ; the estimated difference between mortality in all patients with a sepsis admission diagnosis and mortality in those without ICU-acquired infection was 2.0 % ( 95 % CI , 0.2%-3.8 % ; P = .03 ) by day 60 . Among nonsepsis ICU admissions , ICU-acquired infections had a population attributable mortality fraction of 21.1 % ( 95 % CI , 0.6%-41.7 % ) by day 60 . Compared with baseline , blood gene expression at the onset of ICU-acquired infections showed reduced expression of genes involved in gluconeogenesis and glycolysis . CONCLUSIONS AND RELEVANCE Intensive care unit-acquired infections occurred more commonly in patients with sepsis with higher disease severity , but such infections contributed only modestly to overall mortality . The genomic response of patients with sepsis was consistent with immune suppression at the onset of secondary infection Purpose The optimal treatment duration for ventilator-associated pneumonia is based on one study dealing with late-onset of the condition . Shortening the length of antibiotic treatment remains a major prevention factor for the emergence of multiresistant bacteria . Objective To demonstrate that 2 different antibiotic treatment duration s ( 8 versus 15 days ) are equivalent in terms of clinical cure for early-onset ventilator-associated pneumonia . Methods R and omized , prospect i ve , open , multicenter trial carried out from 1998 to 2002 . Measurements The primary endpoint was the clinical cure rate at day 21 . The mortality rate was evaluated on days 21 and 90 . Results 225 patients were included in 13 centers . 191 ( 84.9 % ) patients were cured : 92 out of 109 ( 84.4 % ) in the 15 day cohort and 99 out of 116 ( 85.3 % ) in the 8 day cohort ( difference = 0.9 % , odds ratio = 0.929 ) . 95 % two-sided confidence intervals for difference and odds ratio were [ −8.4 % to 10.3 % ] and [ 0.448 to 1.928 ] respectively . Taking into account the limits of equivalence ( 10 % for difference and 2.25 for odds ratio ) , the objective of demonstrative equivalence between the 2 treatment duration s was fulfilled . Although the rate of secondary infection was greater in the 8 day than the 15 day cohort , the number of days of antibiotic treatment remained lower in the 8 day cohort . There was no difference in mortality rate between the 2 groups on days 21 and 90 . Conclusion Our results suggest that an 8-day course of antibiotic therapy is safe for early-onset ventilator-associated pneumonia in intubated patients . Trial Registration Clinical Trials.gov 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 Introduction The development of resistance by bacterial species is a compelling issue to reconsider indications and administration of antibiotic treatment . Adequate indications and duration of therapy are particularly important for the use of highly potent substances in the intensive care setting . Until recently , no laboratory marker has been available to differentiate bacterial infection from viral or non-infectious inflammatory reaction ; however , over the past years , procalcitonin ( PCT ) is the first among a large array of inflammatory variables that offers this possibility . The present study aim ed to investigate the clinical usefulness of PCT for guiding antibiotic therapy in surgical intensive care patients . Methods All patients requiring antibiotic therapy based on confirmed or highly suspected bacterial infections and at least two concomitant systemic inflammatory response syndrome criteria were eligible . Patients were r and omly assigned to either a PCT-guided ( study group ) or a st and ard ( control group ) antibiotic regimen . Antibiotic therapy in the PCT-guided group was discontinued , if clinical signs and symptoms of infection improved and PCT decreased to < 1 ng/ml or the PCT value was > 1 ng/ml , but had dropped to 25 to 35 % of the initial value over three days . In the control group antibiotic treatment was applied as st and ard regimen over eight days . Results A total of 110 surgical intensive care patients receiving antibiotic therapy after confirmed or high- grade suspected infections were enrolled in this study . In 57 patients antibiotic therapy was guided by daily PCT and clinical assessment and adjusted accordingly . The control group comprised 53 patients with a st and ardized duration of antibiotic therapy over eight days . Demographic and clinical data were comparable in both groups . However , in the PCT group the duration of antibiotic therapy was significantly shorter than compared to controls ( 5.9 + /- 1.7 versus 7.9 + /- 0.5 days , P < 0.001 ) without negative effects on clinical outcome . Conclusions Monitoring of PCT is a helpful tool for guiding antibiotic treatment in surgical intensive care patients . This may contribute to an optimized antibiotic regimen with beneficial effects on microbial resistance and costs in intensive care medicine . Annotation Results were previously published in German in Anaesthesist 2008 ; 57 : 571–577 ( PMID : 18463831).Trial registration IS RCT Objective : We sought to evaluate whether procalcitonin was superior to C-reactive protein in guiding antibiotic therapy in intensive care patients with sepsis . Design : R and omized open clinical trial . Setting : Two university hospitals in Brazil . Patients : Patients with severe sepsis or septic shock . Interventions : Patients were r and omized in two groups : the procalcitonin group and the C-reactive protein group . Antibiotic therapy was discontinued following a protocol based on serum levels of these markers , according to the allocation group . The procalcitonin group was considered superior if the duration of antibiotic therapy was at least 25 % shorter than in the C-reactive protein group . For both groups , at least seven full-days of antibiotic therapy were ensured in patients with Sequential Organ Failure Assessment greater than 10 and /or bacteremia at inclusion , and patients with evident resolution of the infectious process had antibiotics stopped after 7 days , despite biomarkers levels . Measurements and Main Results : Ninety-four patients were r and omized : 49 patients to the procalcitonin group and 45 patients to the C-reactive protein group . The mean age was 59.8 ( SD , 16.8 ) years . The median duration of antibiotic therapy for the first episode of infection was 7.0 ( Q1–Q3 , 6.0–8.5 ) days in the procalcitonin group and 6.0 ( Q1–Q3 , 5.0–7.0 ) days in the C-reactive protein group ( p = 0.13 ) , with a hazard ratio of 1.206 ( 95 % CI , 0.774–1.3 ; p = 0.13 ) . Overall , protocol overruling occurred in only 13 ( 13.8 % ) patients . Twenty-one patients died in each group ( p = 0.836 ) . Conclusions : C-reactive protein was as useful as procalcitonin in reducing antibiotic use in a predominantly medical population of septic patients , causing no apparent Objective Some patients with the phenotype of severe sepsis may have no overt source of infection or identified pathogen . We investigated whether a procalcitonin-based algorithm influenced antibiotic use in patients with non-microbiologically proven apparent severe sepsis . Design This multicentre , r and omised , controlled , single-blind trial was performed in two parallel groups . Setting Eight intensive care units in France . Participants Adults with the phenotype of severe sepsis and no overt source of infection , negative microbial cultures from multiple matrices and no antibiotic exposure shortly before intensive care unit admission . Intervention The initiation and duration of antibiotic therapy was based on procalcitonin levels in the experimental arm and on the intensive care unit physicians ’ clinical judgement without reference to procalcitonin values in the control arm . Main outcome measure The primary outcome was the proportion of patients on antibiotics on day 5 postr and omisation . Results Over a 3-year period \n Output:\n " }, { "from": "agent", "value": "Conclusions : Although the duration of antibiotic therapy is reduced with procalcitonin-guided therapy or prespecified limited duration , meta- analysis and trial sequential analyses are inconclusive for mortality benefit ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background —Transvenous pacemaker and defibrillator implantation is an exp and ing practice in pediatric and congenital heart disease patients , and given the finite longevity of current lead design s , lead extraction is an eventuality for a significant subset of these patients . Data on the safety and efficacy of different lead extraction techniques in this specific patient population are limited . Methods and Results —We report our experience from a single-center cohort study with a retrospective review of prospect ively collected data on all lead extraction s performed between January 2002 and December 2008 . Lead extraction procedures involved a total of 144 patients and 203 leads . Of these , 61 patients ( 42 % ) were female and 86 ( 60 % ) had structural heart disease . Successful simple extraction , requiring the use of only a nonlocking stylet , was achieved in 59 ( 29 % ) leads . Of the remaining leads , 35 were ab and oned and 109 underwent complex extraction techniques , including a radiofrequency-powered sheath used in 78 of 109 leads . Successful extraction was achieved in 80 % ( 162/203 ) of all leads and 94 % ( 103/109 ) of leads undergoing a complex extraction . On multivariable analysis , older lead age ( odds ratio [ OR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.48 to 0.82 ; P<0.0001 ) , ventricular lead position ( OR , 0.40 ; 95 % CI , 0.20 to 0.79 ; P=0.015 ) , and polyurethane insulation ( OR , 0.34 ; 95 % CI , 0.14 to 0.80 ; P=0.017 ) were found to be associated with a decreased likelihood of simple extraction . There were 4 major and 4 minor procedural complications involving 8 patients and no procedure-related deaths . On univariate analysis , lead age ( OR , 1.28 ; 95 % CI , 1.09 to 1.50 ; P=0.002 ) was the only factor associated with procedural complications . Conclusions —The majority of leads implanted in pediatric and congenital heart disease patients can be extracted successfully ; however , the procedure carries a risk of serious complications . Older lead age , ventricular leads , and polyurethane insulation were independent predictors of the decreased likelihood of an extraction by simple traction BACKGROUND The aim of this study was to investigate whether transvenous lead removal is safe and effective in patients with lead vegetations greater than 1 cm in size . METHODS From 1991 to 2005 , a total of 53 patients underwent pacemaker or ICD lead removal for vegetations . Transvenous lead removal using locking stylets and sheaths was performed in 30 patients ( 56.6 % ) and was found to be effective in 29 of those patients . In 1 patient , due to rupture of the lead , open heart removal of the ventricular lead remnant and tricuspid valve repair had to be performed due to persistent infection . In 23 of these patients , transesophageal echocardiography ( TEE ) verified vegetations greater than 1 cm in size . The remaining patients underwent primary lead removal using sternotomy and extracorporeal circulation ( ECC ) . Pacemaker pocket infection was found in 16 patients ( 55.2 % ) of the transvenous study group and in 11 patients ( 45.8 % ) of the ECC group ( P = 0.72 ) . RESULTS Perioperative mortality was 5.7 % ( 3 patients ) ; all of them underwent primary ECC removal and had severe endocarditis of the tricuspid valve . None of the patients who underwent transvenous lead removal died and there were no further complications such as pericardial tamponade or major pulmonary embolism requiring further interventions , even in patients demonstrating large vegetations . CONCLUSIONS This study demonstrates that transvenous lead removal is a safe and highly effective procedure for the removal of infected pacemaker and ICD leads , even in patients with large vegetations . Embolism to the lung proceeds mainly without further complications ; however , patients with vegetations that might obstruct a main stem of the pulmonary artery should undergo ECC removal BACKGROUND Lead extraction is increasingly necessary given the exponential growth in cardiac device implantation . Meanwhile , the tools , indications , and outcomes of this procedure continue to change . OBJECTIVE The purpose of this study was to examine contemporary indications , outcomes , and complications of transvenous lead extraction in a large series of patients at a high-volume lead extraction center . METHODS We performed a retrospective cohort study of consecutive patients undergoing lead extraction at a single , high-volume center . Patient and lead characteristics and the indications , outcomes , and need for laser assistance were analyzed . RESULTS From January 2000 to March 2007 , a total of 975 chronic endovascular leads were removed from 498 patients . Median implant duration was 5.7 years ( range 0.5 - 32.7 years ) . Indications were infection ( 60.3 % ) , mechanical lead failure ( 29.3 % ) , and up grade of device system ( 8.8 % ) . Over the study period , lead malfunction decreased relative to other indications . Laser assistance for extraction was more likely with leads implanted longer than 3.4 years compared to less than 3.4 years ( odds ratio 6.15 , 95 % confidence interval 3.35 - 11.28 ) and with implantable cardioverter-defibrillator leads compared to pacemaker leads ( odds ratio 3.44 , 95 % confidence interval 1.84 - 6.43 ) . Overall , 97.5 % of the leads were completely removed . Major complications occurred in 2 ( 0.4 % ) patients . Only one patient required cardiac surgery . No deaths occurred . CONCLUSION In a high-volume center , lead extraction has a high success rate and low complication rate . Infection was the most common indication overall . Lead failure has decreased in relative proportion . Implantable cardioverter-defibrillator leads and longer lead implant time are associated with a requirement for laser lead extraction OBJECTIVES The purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction . BACKGROUND Fibrotic attachments that develop between chronically implanted pacemaker leads and to the venous , valvular and cardiac structures are the major obstacles to safe and consistent lead extraction . Locking stylets and telescoping sheaths produce a technically dem and ing but effective technique of mechanically disrupting the fibrosis . However , ultraviolet excimer laser light dissolves instead of tearing the tissue attachments . METHODS A r and omized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads . The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath . Success for both groups was defined as complete lead removal with the r and omized therapy without complications . RESULTS Complete lead removal rate was 94 % in the laser group and 64 % in the nonlaser group ( p = 0.001 ) . Failed nonlaser extraction was completed with the laser tools 88 % of the time . The mean time to achieve a successful lead extraction was significantly reduced for patients r and omized to the laser tools , 10.1 + /- 11.5 min compared with 12.9 + /- 19.2 min for patients r and omized to nonlaser techniques ( p < 0.04 ) . Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients , including one death ( p = NS ) . CONCLUSIONS Laser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks BACKGROUND Cardiac resynchronization therapy ( CRT ) device and coronary sinus ( CS ) lead extraction are required due to the occurrence of systemic infection , malfunction , or up grade . Relevant research of CS lead extraction is rare , especially in developing countries because of the high cost and lack of specialized tools . We aim ed to evaluate percutaneous extraction of CS leads by modified conventional techniques . METHODS Of 200 patients referred for lead extraction from January 2007 to June 2011 , 24 ( 12.0 % ) involved CS leads ( 24 CS leads ) . We prospect ively analyzed clinical characteristics , optimized extraction techniques and feasibility of extraction . RESULTS Complete procedural success was achieved in 23 patients ( 95.8 % ) , and the clinical success in 24 patients ( 100.0 % ) . The leading indication for CS lead extraction was infection ( 66.7 % ) . Mean implant duration was ( 29.5 ± 20.2 ) months ( range , 3 - 78 months ) . Sixteen CS leads ( 66.6 % ) were removed with locking stylets plus manual traction by superior transvenous approach . Mechanical dilatation and counter-traction was required to free fibrotic adhesions and extract 4 CS leads ( 16.7 % ) , which had longer implant duration than other leads ( ( 62.5 ± 12.3 ) vs. ( 22.9 ± 14.1 ) months , P < 0.05 ) . Another 4 CS ( 16.7 % ) leads were removed by modified and innovative snare techniques from femoral vein approach . Median extraction time was 11 minutes ( range , 3 - 61 minutes ) per CS lead , which had significant correlation with implant duration ( r = 0.8 , P < 0.001 ) . Sixteen patients ( 66.6 % ) were reimplanted with new devices at a median of 7.5 days after extraction . Median followed-up was 23.5 months ( range , 8 - 61 months ) , three patients died due to sudden cardiac death ( 26 months ) , heart failure ( 45 and 57 months , respectively ) . CONCLUSION The modified procedure was proved to be practical for percutaneous extraction of CS leads , especially in developing countries lacking expensive powered sheaths AIMS The aim of this study is to investigate the safety and effectiveness of Excimer laser-assisted lead extraction in Europe . The final European multi-centre study experience is presented . METHOD AND RESULTS The Excimer is a cool cutting laser ( 50 degrees C ) with a wavelength of 308 nm . The energy is emitted from the tip of a flexible sheath and is absorbed by proteins and lipids , 64 % of the energy is absorbed at a tissue depth of 0.06 mm . The sheath is positioned over the lead , and the fibrosis surrounding the lead is vaporized while advancing the sheath without damaging other leads . From August 1996 to March 2001 , 383 leads ( 170 atrial , 213 ventricular ) in 292 patients ( mean age 61.6 years , range 13 - 96 ) were extracted at 14 European centres . Mean implantation time was 74 months ( 3 - 358 ) . Most frequent indications were pocket infection ( 26 % ) , non-functional leads ( 21 % ) , patient morbidity ( 21 % ) , septicaemia or endocarditis ( 14 % ) , erosion ( 5 % ) , and lead interference ( 8 % ) . Median extraction time was 15 min ( 1 - 300 ) . Complete extraction was achieved in 90.9 % of the leads and partial extraction in 3.4 % . Extraction failed in 5.7 % of the leads . Major complications = perforations caused 10/22 ( 3.4/5.7 % ) of the failures . Most partially extracted patients were considered clinical ly successful , as only minor lead parts without clinical significance were left . Femoral non-laser technique was used to remove 8/12 of the non-complication failures . The total complication rate , including five minor complications ( 1.7 % ) , was 5.1 % . No in-hospital mortality occurred . CONCLUSION Pacing and implantable cardioverter-defibrillator leads can safely , effectively , and predictably be extracted . Open-heart extraction s can be limited to special cases . The results indicate that the traditional policy of ab and oning redundant leads , instead of removing them , may be obsolete in many patients AIMS Both electrosurgical dissection ( EDS ) and laser tools are effective in the extraction of chronic implanted endovascular leads . It is unclear which is superior . We undertook a retrospective single-centre study to assess this . METHODS AND RESULTS In our institution from 2000 to 2004 , all extraction s requiring an ablative sheath were performed using the EDS system . In 2004 , an excimer laser system was acquired , which became the first choice . Consecutive patients undergoing extraction requiring an ablative sheath ( EDS or laser ) were studied . From 2000 to 2007 , 140 leads were extracted from 74 patients ( EDS 31 and laser 43 ) . Procedural success was non-significantly higher in the laser vs. the EDS group ( 95 vs. 87 % ) . In the EDS group , one patient suffered tamponade requiring surgery ; in the laser group , one patient suffered a significant pericardial effusion treated conservatively . There were no deaths . Procedure and fluoroscopy times were similar between groups . More patients were referred for primary surgical extraction in the EDS vs. the laser era ( 7 vs. 0 , P = 0.003 \n Output:\n " }, { "from": "agent", "value": "RESULTS When meta-analyses were carried out separately for the studies with larger and smaller sample sizes , either using EHRA or Lexicon classification criteria , no clear differences emerged in the combined rate of major complications or intraoperative deaths .\nIn contrast , both minor complications and mortality at 30 days decreased as centre volume increased .\nIn our meta- analysis of observational studies , patients who have been treated in higher volume centres have a lower probability of minor complications and death at 30 days regardless of the infection rate , length of lead duration , type of device , and type of extraction" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background . Multiple laser systems are available for the purpose of hair removal . Objective . The purpose of this study was to determine the safety and long‐term efficacy of the 800 nm , pulsed diode laser at reducing hair count . Methods . Fifty volunteers , primarily Fitzpatrick skin types II and III , with dark brown or black hair , were treated with a diode laser ( 800 nm , 10–40 J/cm2 , 5–30 msec , 9 mm 9 mm , 5 ° C chilled h and piece ) . Each subject had eight treatment sites at varying fluences and pulse duration s , as well as a varying number of treatments and pulses . Hair counts were obtained at each site at baseline , 1 , 3 , 6 , 9 , and an average of 20 months after treatment . Results . After one treatment , hair regrowths ranged from 22 to 31 % at the 1‐month follow‐up visit , then remained stable between 65 and 75 % from the 3‐month to the averaged 20‐month follow‐up . After two treatments there were relatively longer growth delays , with hair regrowths plateauing beginning at 6 months after treatment and ranging from 47 to 66 % for the remainder of the follow‐up evaluations . Side effects were limited to pigmentary changes , transient in subjects with skin types II and III . Conclusions . This 800 nm diode laser with a chilled sapphire tip and variable pulse duration is safe and effective for long‐term hair reduction in individuals with skin types II and III Background . The C and ela alex and rite and the Coherent diode laser systems come equipped with built‐in skin cooling systems that are design ed to both protect the epidermis , allowing higher fluences , and to alleviate discomfort . Nevertheless , pain can be a significant problem especially with treatment of larger areas . Scatter of the laser beam is reportedly affected by the spot size . It is cl aim ed that larger spot sizes are more effective at identical fluences . Objective . This study evaluated the effectiveness of a topical 5 % lidocaine cream ( ELA‐Max ) to control pain and compared pain levels at identical fluences between the 8 mm and 12 mm spot size of the alex and rite laser and between the alex and rite and diode laser with its 9 mm spot size . Methods . The study was conducted in the axillae of 12 patients . Each axilla was divided in half for side‐by‐side comparison . Half of the right axilla was treated with the alex and rite 8 mm and the other half with the 12 mm spot size at identical fluences . The left axilla was treated at the maximum tolerated fluences with the alex and rite 12 mm spot size and the diode 9 mm spot size . Results . At identical fluences and other parameters , there was significantly more pain with the alex and rite 12 mm spot size than with the alex and rite 8 mm spot size , both with or without topical anesthesia . The alex and rite laser was significantly less painful than the diode laser both with and without topical anesthetic . The difference was most noticeable between the alex and rite 8 mm spot size and the diode 9 mm spot size . Topical 5 % lidocaine anesthesia was effective in reducing pain , though not completely , for both the alex and rite and the diode lasers . Conclusion . Topical 5 % lidocaine cream is a simple and effective method for reducing patient discomfort during laser hair removal procedures , even when a skin cooling device is being used . A larger spot size causes more pain than a smaller spot size at identical fluences . The 800 nm diode laser causes greater discomfort than the 755 nm alex and rite laser Promising clinical results have been obtained with the normal mode ruby laser for removal of unwanted hair . Melanin within the hair follicles is thought to act as target for the ruby laser pulses , whereas epidermal melanin is thought to be a competitive chromophore , responsible for potential side effects . This study aim ed ( i ) to objectify postoperative changes in skin pigmentation and texture and ( ii ) to evaluate the importance of variations in preoperative skin pigmentation for the development of side effects 12 weeks after 1 treatment with the normal-mode ruby laser . A total of 17 volunteers ( skin types I-IV ) were laser-treated in the hairy pubic region ( n = 51 test areas ) . A shaved test area served as control . Skin reflectance spectroscopical measurements , 3-dimensional surface contour analysis and ultrasonography objectified postoperative changes in skin pigmentation and texture . Blinded clinical assessment s revealed postoperative hyperpigmentation ( 2 % of test areas ) and hypopigmentation ( 10 % ) , whereas no textural changes were seen . Reflectance spectroscopically-determined pigmentary changes depended on the degree of preoperative skin pigmentation , fairly pigmented skin types experiencing sub clinical hyperpigmentation and darkly pigmented skin types experiencing sub clinical hypopigmentation . Three-dimensional surface profilometry documented similar pre- and postoperative surface contour parameters , indicating that the skin surface texture is preserved after laser exposure . Ultrasonography revealed similar skin thicknesses in laser-exposed and untreated control areas . It is concluded that normal-mode ruby laser treatment is safe for hair removal in skin types I-IV BACKGROUND AND OBJECTIVES The aim was to study hair removal efficacy , and possible side effects of two commercially available long pulsed diode lasers . The radiant exposure was selected to a value of 35 J/cm2 , which is frequently used in the clinic in accordance with manufacturer 's recommendations . STUDY DESIGN / MATERIAL S AND METHODS A prospect i ve clinical study was performed on twenty-nine patients with hair color ranging from light brown to black on the upper lip . One half of the upper lip was r and omly selected for treatment with the MedioStar laser ; the contralateral half of the lip was treated with the LightSheer laser . Three treatments were performed at 6 - 8 week intervals . Percent hair reduction and acute- and long-term side effects were evaluated after treatment . RESULTS The average hair reductions 6 months after the first treatment were 49 % with the MedioStar laser and 48 % with the LightSheer laser . No scarring or pigmentary change of the skin was observed after any of the treatments with either laser . However , differences in acute side effects such as degree of erythema and burned hairs were observed . CONCLUSIONS No statistically significant differences in hair removal efficacy were observed . These results agree with mathematical modeling , which also offers a method to estimate hair removal efficacy and adverse effects for a range of hair characteristics and laser parameters BACKGROUND AND OBJECTIVE The aim was to investigate the efficacy , side effects , and the long-term results of a long pulsed Nd : YAG-Laser for hair removal in different hair colors and skin types . STUDY DESIGN / MATERIAL S AND METHODS We performed a prospect i ve clinical study with 29 volunteers . Treatment was performed on the lower leg with a long pulsed Nd : YAG-Laser . Five test areas were treated 1 - 5 times in monthly intervals ; one served as control . Follow-up investigations were performed at each session , and 3 , 6 , and 12 months after the last therapy . No depilatory treatment except shaving was allowed during the time of follow-up . Percentual hair loss , short- and long-term side effects , and pain during the treatment were evaluated . RESULTS After one month , a hair loss of greater than 50 % was found in 44.9 % of the areas treated once . With up to five treatments , this percentage increased up to 71.5 % . One year after therapy , a greater than 50 % hair reduction was still present in 40 % of the five-treatment- areas and in 0 % of the areas treated only once . There were no permanent side effects despite one small scar after a folliculitis . CONCLUSIONS The long pulsed Nd : YAG is suitable to remove hair for more than 12 months effectively , although 4 - 5 sessions are necessary for these results . Blond hair can also be removed , although much less effective . No lasting side effects could be seen . Darker skin types or tanned skin can also be treated without side effects . A cooling may be advisable due to the pain reported by the volunteers OBJECTIVE To determine the safety and effectiveness of a long-pulsed Nd : YAG laser at 1064 nm in effecting long-term hair reduction in patients with darkly pigmented skin . DESIGN Nonr and omized before-after clinical and histological trial . SETTING Private practice , ambulatory care facility . PATIENTS Twenty women with skin phototypes IV through VI and dark brown to black terminal hair on the face , axillae , or legs . INTERVENTION A series of 3 long-pulsed ( 50-millisecond ) 1064-nm Nd : YAG laser treatments at fluences ranging from 40 to 50 J/cm(2 ) were delivered to the identified treatment areas on a monthly basis by a single operator . MAIN OUTCOME MEASURES Global clinical grading scores of comparable before-after treatment photographs were determined by 2 independent medical assessors during each laser session and 1 , 3 , 6 , and 12 months postoperatively . A dermatopathologist review ed unmarked histological specimens obtained at baseline , immediately after the initial laser treatment , and at 1 and 6 months after the final laser session . RESULTS Substantial hair reduction was seen after each of the 3 treatment sessions . Prolonged hair loss was observed 12 months after the final laser treatment ( 70%-90 % hair reduction ) . Axillary hair was substantially more responsive to laser irradiation than was hair located on the legs and face . Adverse effects included mild to moderate treatment pain and rare occurrences of vesiculation and transient pigmentary alteration without fibrosis or scarring . Histological tissue changes mirrored clinical response rates , with evidence of selective follicular injury without epidermal disruption . CONCLUSION The long-pulsed 1064-nm Nd : YAG laser is a safe and effective method of long-term hair reduction in patients with darkly pigmented skin Laser-assisted hair removal has been reported previously with the Nd : YAG laser , the long-pulse ruby laser , the long-pulse Alex and rite laser , and the short-pulse Alex and rite laser . Results with all these lasers have been successful ; however , it has been postulated that the long-pulse Alex and rite laser would have a lower complication rate and greater efficacy at identical fluences than the short-pulse Alex and rite laser . The authors chose to compare directly the pulsed Alex and rite lasers for speed of application , complications , and results . Eighteen patients who desired hair removal were entered into the study . There were 10 female and 8 male patients , with a mean age of 36 years . All skin types from Fitzpatrick classes I through VI were treated . The body areas treated consisted of the face , ears , neck , back , arms , upper thighs , bikini lines , legs , and breasts . One side of the body was treated with the short-pulse ( 2-msec ) Alex and rite laser ( Sharplan Epitouch 5100 ) . The other half was treated with a long-pulse ( 20-msec ) Alex and rite laser . Both lasers were set at the same fluence for each patient . Patients reported a 60 % to 80 % reduction in hair growth at 6 months . Both sides were identical with regard to return of hair growth and complications such as hypopigmentation . Both the long- and short-pulse Alex and rite laser systems yielded an effective method of hair reduction with minimal complications . Equal results and complications were obtained with the two systems . The only exception was that the length of the procedure was shorter with the short-pulse Alex and rite laser OBJECTIVE To determine the most effective treatment parameters for laser-assisted hair removal using a Q-switched neodymium : yttrium-aluminum-garnet ( Nd : YAG ) laser . DESIGN Prospect i ve study to determine the effectiveness of Q-switched ND : YAG laser-assisted hair removal under varying pretreatment protocol s. Hair growth was assessed after laser treatment , and the results were compared with those of wax epilation at 4 , 12 , and 24 weeks . SETTING A private ambulatory laser facility and academic referral center . INTERVENTION Laser-assisted hair removal was performed under 4 different pretreatment conditions . Eighteen areas of unwanted body and facial hair from 12 study subjects were divided into 4 quadrants . Wax epilation followed by application of a carbon-based solution and exposure to Q-switched Nd : YAG laser radiation was performed on 1 quadrant . A second quadrant was wax epilated and exposed to Q-switched Nd : YAG laser radiation without prior carbon solution application . A third quadrant was exposed to laser radiation alone , and a final quadrant was wax epilated to serve as the control . Follow-up evaluations at 1 , 3 , and 6 months consisted of photographic documentation , manual hair counts , and patient hair-density estimates . MAIN OUTCOME MEASURE Percentage of hair regrowth as assessed by objective hair counts and patient subjective evaluations . RESULTS Mean percentage of hair regrowth at 1 month was 39.9 % for the wax-carbon-laser quadrant , 46.7 % for the wax-laser quadrant , 66.1 % for the laser-alone quadrant , and 77.9 % for the wax control quadrant . The percentage of hair regrowth approximately doubled by 3 months but was significantly delayed in all laser-treated quadrants regardless of pretreatment protocol . Full hair regrowth in all anatomic locations was observed by month 6 . Patient subjective evaluations of hair density closely approximated hair count data . No adverse effects or long-term complications were observed . CONCLUSIONS A single hair-removal treatment with the Q-switched Nd : YAG las \n Output:\n " }, { "from": "agent", "value": "There appeared to be a short-term effect of approximately 50 % hair reduction with alex and rite and diode lasers up to six months after treatment , whereas little evidence was obtained for an effect of intense pulsed light , neodymium : YAG or ruby lasers .\nLong-term hair removal was not documented with any treatment .\nPain , skin redness , swelling , burned hairs and pigmentary changes were infrequently reported adverse effects .\nSome treatments lead to temporary short-term hair removal ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE The aim of this follow-up study was to compare 3-dimensional ( 3D ) and st and ard ( Champy 's ) miniplate fixation in the management of m and ibular fractures , and to analyze advantages and disadvantages of one over the other . PATIENTS AND METHODS A prospect i ve r and omized clinical trial was carried out in patients with well-defined inclusion and exclusion criteria . Patients were followed for 2 months for wound dehiscence , infection , segmental mobility , postoperative occlusion , significant period of postoperative complications , and radiological evaluation of reduction and fixation . RESULTS Twenty patients were enrolled in both the groups with no case of wound dehiscence . In group 1 , 2 patients had mild segmental mobility ( P = .07 ) , 2 patients had surgical site infection ( P = .07 ) , and 2 patients involving mental nerve had involved roots of teeth ( P = .07 ) . Radiological evaluation did not show any statistically significant difference in reduction ( P = 1.4 ) , but showed a significant difference ( P = .03 ) in fixation between the 2 groups , especially in cases involving the mental nerve ( ie , fracture near or involving the mental foramen ) and oblique fractures . CONCLUSION Champy 's miniplate system is a better and easier method than the 3D miniplate system for fixation of m and ibular fractures . In comparison , the 3D miniplate system is unfavorable for use in cases of oblique fractures and those involving the mental nerve , and is also difficult to adapt . In most cases , it provides good stability but with excessive implant material because of extra vertical bars incorporated for countering the torque forces . However , operative time is less because of simultaneous stabilization at both superior and inferior borders Introduction The purpose of this study was to compare the outcome of open treatment of m and ibular fracture ( symphysis or parasymphysis ) using lag screw or mini plate clinical ly as well as radiologically in young ( age range 12–45 years ) and healthy individuals of poor socioeconomic status . Method This prospect i ve study was conducted on 30 patients diagnosed as cases of displaced m and ibular anterior fractures treated with open reduction and internal fixation . The patients were then r and omly allocated to either of two groups––Group A : Two 2.5 mm stainless steel lag screws were placed in 15 patients . Group B : Two 2.5 mm stainless steel mini plates were placed in 15 patients for the fixation of fractures . Subsequent follow up was done on 2nd , 4th , 6th and 8th week postoperatively . During every follow up patient was assessed clinical ly for infection , malocclusion , loosening of plate/screw , sensory disturbance , plate fracture , malunion/non-union , devitalisation of associated dentoalveolar segment and masticatory efficiency . Radiographs were taken if necessary and patients were further assessed for any complaint . Pain was objective ly measured using a visual analogue scale , bite force was measured using a bite force transducer at biweekly interval . The data collected was subjected to unpaired t test and paired t test for statistical analysis . Results During follow up period a significant improvement in bite force was present in both the groups , with more improvement seen in the lag screw group ( p < 0.01 ) . There was a significant pain reduction present in the lag screw group ( p < 0.01 ) and also masticatory efficiency showed a steadier improvement in lag screw group while mini plate group patients showed a tendency to masticate only food items of medium hard consistency . Conclusion The sample size is small to conclude lag screws are better than mini plates but the result of our study provides a basis for further studies done to conclude that the application of LAG SCREW is an effective , inexpensive , quick treatment modality to accelerate healing of fresh , displaced m and ibular anterior fracture Objective To compare the efficacy and surgical outcome of treatment of anterior m and ibular fracture using either 2.0 mm titanium miniplate or 2.4 mm titanium lag screw technique . Material s and Methods A total of 30 patients were managed by open reduction and internal fixation utilizing the miniplate and lag screw technique for fractures of anterior m and ible . The patients were r and omly divided into two groups . Group I : ( 15 patients ) were treated with Leibinger , 2.0 mm titanium mini plates system with self-tapping screws and Group II : ( 15 patients ) were treated with 2.4 mm cortical lag screw ( Synthes ) . Intraoperatively duration of surgery was measured from the time incision was placed till the closure of wound . Subsequent follow up was done at 3 , 6 , 12 , 24 weeks , postoperatively . During every follow up , patients were assessed clinical ly for malocclusion , neurosensory deficit , biting efficiency , implant failure , mal-union/non-union . Pre and postoperative radiographs were taken to assess the gap between fracture segments . Results were evaluated using Chi square and the unpaired t test . Results In our study , the mean duration of surgery ( hours ) was 1.97 ± 0.52 for group I and 1.26 ± 0.55 for group II . The difference was found to be statistically significant ( p value 0.001 ) . i.e. more time was taken in case of surgery with mini-plates when compared to the lag screw . Short surgical procedure reduces the incidence of infectious complications , which significantly lowers the financial burden . The mean post-operative radiographic distance between all measuring points were considerably more in case of mini-plate group as compared to lag screw group . Lag screw group showed faster improvement in terms of biting efficiency as compared to mini-plate group which showed a tendency to masticate only medium hard food items by 24 weeks . In both groups , no postoperative malocclusion was noted . In initial weeks , neurosensory deficit was seen more in mini-plate group as compared to lag screw group but after six weeks all patients showed improvement in neurosensory function without any permanent nerve damage . Conclusion According to this prospect i ve study , rigid internal fixation provided by lag screw technique for anterior m and ibular fracture offers several advantages over conventional bone plating . It is an excellent means of achieving rapid and safe fixation which is followed by primary bone healing in anterior m and ibular fractures , without any major complications Aim : To compare and evaluate the treatment outcome and postoperative complications in m and ibular fractures using 2- and 3-dimensional miniplates . Material s and Methods : This study consisted of a sample of 28 patients ( 40 fracture sites ) divided r and omly but equally ( single-blind control trial study ) into two groups . Each group contains 14 patients ( 20 similar fracture sites in each group ) . Group 1 was treated with open reduction and internal fixation using 3-dimensional ( 3-D ) miniplates . Group II was treated using 2-dimensional ( 2-D ) 2-mm miniplates . Results : Out of 14 patients treated by conventional 2-mm miniplates , 2 patients developed occlusal discrepancy , another 2 had postoperative mobility at fracture site , and 1 developed plate failure and subsequent infection , which was treated by removal of the plate under antibiotic coverage . One patient treated by 3-dimensional plates had tooth damage . Statistical Analysis : Chi-square test . Conclusion : The results of this study suggested that the treatment of m and ibular fractures ( symphysis , parasymphysis , and angle ) with 3-dimensional plates provided 3-dimensional stability and carried low morbidity and infection rates . The only probable limitations of 3-dimensional plates were excessive implant material due to the extra vertical bars incorporated for countering the torque forces Purpose To compare the efficacy of the 3D miniplates to st and ard miniplates in the osteo synthesis of m and ibular symphysis and parasymphysis fractures on the basis of clinical parameters and radiographic evaluation . Patients and Methods A prospect i ve r and omized clinical trial was conducted to treat consecutive m and ibular symphysis and parasymphysis fractures . The patients were r and omly divided into 2 groups . The patients underwent osteo synthesis in group A with 3D titanium miniplates and in group B with conventional titanium miniplates . The cause of trauma , the number of days from injury to surgery , average age and gender were all review ed . The assessment of the patients was done at 1 , 3 , and 6 weeks and 3 months using the clinical parameters and radiographic evaluation . Results Eighty patients with isolated symphysis or parasymphysis fracture met the inclusion criteria . In our study , a statistically significant difference was not found in the clinical parameters such as pain , swelling , infection , paresthesia , hardware failure , and mobility between the fracture segments . Similarly Radiological evaluation did not show any statistically significant difference in reduction between the 2 groups . 3D plates are difficult to adapt and use sometimes , but operative time is less with them in treatment of symphysis and parasymphysis fractures . Conclusion The use of 3D miniplates for symphysis and parasymphysis fracture fixation was efficacious enough to bear the masticatory load during osteo synthesis of the fracture . Although 3D miniplate system is difficult to adapt and difficult to use in cases of fractures involving the mental nerve , they provide the advantage of less operative time and less implant material in treatment of symphysis and parasymphysis fracture , with clinical results almost similar to those seen with conventional miniplate osteo synthesis PURPOSE The aim of this study was to compare efficacy between the single non-compression titanium miniplate and single three-dimensional titanium miniplate in m and ibular angle fracture treatment . METHOD AND MATERIAL S A prospect i ve study of 20 patients with m and ibular angle fractures . Patients were r and omly categorized into two groups with 10 patients in each group . Group-I patients were treated with single 2.0 mm conventional titanium miniplate , Group-II patients were treated with single 2.0 mm three-dimensional titanium miniplate according to Champy 's principles . Parameters such as stability of fracture fragments , occlusion , mouth opening , additional fixation required and complications were evaluated at different time intervals . RESULTS In Group-I , about 40 % ( n=4 ) of patients showed unstable fracture fragments on immediate postoperative day whereas in Group-II only 10 % ( n=1 ) of patients with fracture instability . In Group-I , 30 % ( n=3 ) had mild occlusal derangement and 20 % ( n=2 ) had deranged occlusion on immediate postoperative day , where as in Group-II only 20 % ( n=2 ) of patients had mild occlusal derangement . Additional fixation required in 30 % ( n=3 ) of patients in group-I , and 10 % ( n=1 ) in Group-II . 20 % ( n=2 ) of patients in Group-I developed infection . All patients in both the groups had inadequate mouth opening on immediate post operative day , later resumed normal mouth opening . 10 % ( n=1 ) in group-I and 20 % ( n=2 ) of patients in group-II presented with postinjury/preoperative inferior alveolar nerve sensory disturbance with no incidence of postoperative sensory disturbance . None of the patients in both the groups had malunion , nonunion , plate fracture , and loosening of plates and screws . CONCLUSION 3-D titanium miniplates showed more favorable results compared to single conventional titanium miniplate with respect to initial interfragmentary stability and complications \n Output:\n " }, { "from": "agent", "value": "The results of this meta- analysis revealed that the use of both lag screws and 1 plate plus an arch bar were superior to 2 miniplates in reducing the incidence of postoperative complications in the management of AMFs .\nAlso , there were significantly shorter operating times with lag screws and 3-dimensional miniplates over 2 miniplates in the fixation of AMFs" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: OBJECTIVE To observe effect of compound Kushen injection on T-cell subgroups and NK cells in patients with locally advanced non-small-cell lung cancer ( NSCLC ) treated with concomitant radiochemotherapy . METHODS We r and omly divided 60 patients with locally advanced NSCLC who were treated at our hospital between May 2011 and May 2013 into a treatment group and a control group by drawing . The treatment group ( n = 30 ) received concomitant radiochemotherapy plus compound Keshen injection , and the control group ( n = 30 ) received only radiochemotherapy . RESULTS After treatment , levels of CD3 + , CD4 + , CD4+/CD8 + and CD16+/CD56 + cells had significantly increased , and CD8 + cells had significantly decreased , in the treatment group compared with both their pretreatment levels and with levels in the control group . In the control group , post-treatment levels of CD3 + , CD4 + , CD4 + /CD8 + and CD16+/CD56 + cells were not significantly changed from pretreatment levels . The two groups did not significantly differ in their rates of toxicity reactions ( P > 0.05 ) . CONCLUSION Compound Kushen injections can increase immunologic function in patients with locally advanced non-small cell lung cancer who receive concomitant radiochemotherapy The aim of this study was to compare the immune function of patients with cervical cancer and the cancer recurrence rate in patients treated with biological immune therapy combined with chemotherapy or with chemotherapy only . A total of 79 postoperative patients with cervical cancer participated in the present study . They were r and omly divided into a control group and an experimental group . Patients in the control group were treated with cisplatin chemotherapy . Patients in the experimental group were treated with dendritic cell-cytokine-induced killer ( DC-CIK ) cells combined with cisplatin chemotherapy . The CD3 + , CD4 + , CD8 + , CD16 + , CD56 + and CD4+CD25 + cell ratios in peripheral blood , and the expression levels of perforin , granzyme B ( GraB ) and CD107a of peripheral blood mononuclear cells ( P BMC s ) in all patients prior to and following treatment were observed . The changes of immune function and recurrence rate between these two groups prior to and following treatment were compared . Prior to treatment , the lymphocyte ratio had no significant difference between the two groups ( P>0.05 ) . Following treatment , the lymphocyte ratio in the experimental group was significantly higher than that in the control group ( P<0.05 ) . The positive expression levels of perforin , GraB and CD107a of P BMC s in the experimental group following treatment were significantly higher than those prior to treatment and those of the control group ( P<0.05 ) . The cumulative recurrence rate in the experimental group was significantly lower than that in the control group ( P<0.05 ) . In conclusion , in postoperative patients with cervical cancer , treatment with DC-CIK cells combined with cisplatin chemotherapy significantly improved the immune function , reduced the recurrence rate and prolonged the survival time of the patients Background and Objectives : CIK cells are a novel population of efficient immune effector cells with high antitumour activity mainly due to the high proliferation of CD3+CD56 + cells , so may play a role in the development of new forms of adoptive cellular immunotherapy . We started a pilot clinical trial with autologous CIK cells in patients with refractory lymphoma and metastatic solid tumours . This study was aim ed at determining the feasibility of generating a sufficient number of CIK cells in heavily pretreated patients and at assessing treatment toxicity . Design and Methods : CIK cells were generated from peripheral blood mononuclear cells ( MNC ) and incubated in the presence of IFN‐γ followed by OKT3 and IL‐2 . Treatment schedule consisted of three cycles of CIK cells infusions at an interval of 3 weeks . Results : At present 12 patients were enrolled : 6 advanced lymphomas , 5 metastatic kidney carcinoma and 1 hepatocellular carcinoma ( HCC ) . The median number of transferred cells per patient was 28 × 109 ( range , 6–61 ) . Protocol adherence was excellent and the toxicity profile was favourable . After CIK cells infusion , the absolute median count of lymphocytes , CD3 + , CD8 + and CD3+CD56 + cells significantly increased in patient 's peripheral blood . Clinical outcome appeared promising : three patients had complete response ( CR ) and two patients had stabilization of disease with a median follow‐up of 33 months ( range , 9–44 ) . Interpretations and Conclusions : These preliminary data showed that adoptive immunotherapy with CIK cells is a safe therapy with some suggestion of efficacy that significantly enhances immune functions increasing absolute numbers of effector cells without side effects . If confirmed in larger scale studies , these promising results may have a favourable impact on conventional treatment strategy of malignancies . Copyright © 2009 John Wiley & Sons , OBJECTIVE To evaluate the efficacy and safety of autologous cytokine-induced killer ( CIK ) cell t combined with XELOX regimen in treatment of senile advanced gastric cancer . METHODS Forty-six cases of senile advanced gastric cancer patients with a mean age of 70 years were prospect ively divided into two groups according to individual acceptance of CIK cells : 25 patients receiving autologous CIK cell treatment combined with XELOX regimen ( trial group ) and 21 patients receiving simple chemotherapy ( control group ) . Patients in CIK group were matched to those in control group by sex , ages , KPS ranking scores , histological type , pathological grade , and clinical stage . Immune reaction , adverse reaction , time to progression ( TTP ) and overall survival ( OS ) were evaluated . RESULTS Host immune function was increased ( P<0.05 ) and the adverse reaction was decreased in patients of trial group as compared to control group . There were no significant differences in response rate (RR)(33.3 % vs. 23.1 % , P>0.05 ) , disease control rate (DCR)(86.7 % vs. 80.8 % , P>0.05 ) between the two groups . TTP ( 4.8 months vs. 3.1 months , P<0.05 ) and OS ( 7.1 months vs. 5.9 months , P<0.05 ) in trial group were significantly improved as compared to control group . CONCLUSION Autologous CIK cells combined with XELOX regimen can increase immune function , improve clinical efficacy , decrease adverse reaction and prolong OS for senile patients with advanced gastric cancers Purpose To determine the long-term efficacy of adjuvant immunotherapy with autologous cytokine-induced killer ( CIK ) cells for locally advanced gastric cancer patients .Experimental design One hundred and fifty-one patients with stage III/IV gastric cancer who had undergone gastrectomy were enrolled , assigned to two groups ( immunotherapy group versus no immunotherapy group/or control group ) , and followed . Results The 5-year overall survival ( OS ) and 5-year disease-free survival ( DFS ) rates for immunotherapy versus control group were 32.4 versus 23.4 % ( P = 0.071 ) and 28.3 versus 10.4 % ( P = 0.044 ) , respectively . For patients with intestinal-type tumors , the 5-year OS and DFS rates were significantly higher for immunotherapy ( OS , 46.8 vs. 31.4 % and P = 0.045 ; DFS , 42.4 vs. 15.7 % and P = 0.023 ) . In the immunotherapy group , the mean CD3 + level , CD4 + level , and CD4+/CD8 + ratio increased from 50.8 , 26.5 , and 0.9 % , respectively , at baseline to 62.6 , 35.0 , and 1.4 % , respectively , 1 week after the first CIK-cell treatment , returned to baseline after 2 months , and maintained a higher level ( 60.7 ± 8.2 % , 34.2 ± 7.1 % , and 1.3 ± 0.3 % , respectively ) 2 months after 3 cycles of immunotherapy . Conclusions Adjuvant immunotherapy with CIK cells prolongs DFS in patients with locally advanced gastric cancer and significantly improves OS in patients with intestinal-type tumors . Intestinal-type tumors could be selected as an important indication for CIK-cell therapy . This treatment may help improve T-lymphocyte subset distribution and improve the host ’s immune functions , but multiple cycles are necessary for long-term therapeutic efficacy PURPOSE Adoptive cell therapy ( ACT ) with autologous tumor-infiltrating lymphocytes ( TILs ) and high-dose interleukin-2 ( IL-2 ) administered to lymphodepleted patients with melanoma can cause durable tumor regressions . The optimal TIL product for ACT is unknown . PATIENTS AND METHODS Patients with metastatic melanoma were prospect ively assigned to receive unselected young TILs versus CD8(+)-enriched TILs . All patients received lymphodepleting chemotherapy and high-dose IL-2 therapy and were assessed for response , toxicity , survival , and immunologic end points . RESULTS Thirty-four patients received unselected young TILs with a median of 8.0 % CD4(+ ) lymphocytes , and 35 patients received CD8(+)-enriched TILs with a median of 0.3 % CD4(+ ) lymphocytes . One month after TIL infusion , patients who received CD8(+)-enriched TILs had significantly fewer CD4(+ ) peripheral blood lymphocytes ( P = .01 ) . Twelve patients responded to therapy with unselected young TILs ( according to Response Evaluation Criteria in Solid Tumors [ RECIST ] ) , and seven patients responded to CD8(+)-enriched TILs ( 35 % v 20 % ; not significant ) . Retrospective studies showed a significant association between response to treatment and interferon gamma secretion by the infused TILs in response to autologous tumor ( P = .04 ) , and in the subgroup of patients who received TILs from subcutaneous tumors , eight of 15 patients receiving unselected young TILs responded but none of eight patients receiving CD8(+)-enriched TILs responded . CONCLUSION A r and omized selection design trial was feasible for improving individualized TIL therapy . Since the evidence indicates that CD8(+)-enriched TILs are not more potent therapeutically and they are more laborious to prepare , future studies should focus on unselected young TILs Dendritic cells ( DC ) play a crucial role in the induction of an effective antitumor immune response . Cytokine-induced killer ( CIK ) cells , a subset of T lymphocytes , have the capacity to eliminate cancer cells . This study was to evaluate the correlation between the frequency of DC/CIK immunotherapies following regular chemotherapy , the time-to-progression ( TTP ) , and overall survival ( OS ) of advanced non-small lung cancer patients . Sixty patients with IIIB – IV non-small-cell lung carcinoma ( NSCLC ) were enrolled from August 2007 to December 2009 and were r and omized into two groups . All 60 patients received four courses of navelbine – platinum ( NP ) chemotherapy . In one group , 30 patients were treated with adoptive autologous DC/CIK cell transfusion twice every 30 days . In the other group , the patients received immunotherapies more than twice every 30 days . The adverse effects , TTP , and OS were evaluated between the two groups . Median survival time of all 60 patients was 13.80 months . The 1- , 2- , and 3-year overall survival rates were 60.0 , 21.7 , and 15.0 % , respectively . The 1- , 2- , and 3-year overall survival rates of patients receiving more than two immunotherapies were 63.3 , 30.0 , and 23.3 % , and the rates of those receiving two immunotherapies were 56.7 , 13.3 , and 6.7 % , respectively . The difference between the two groups was statistically significant ( P = 0.037 ) . Compared with patients in the fewer immunotherapies group , TTP in the group receiving more immunotherapies significantly prolonged , with the median improving from 6.2 months ( 95 % CI , 5.35–9.24 ) to 7.3 months ( 95 % CI , 5.45–6.95 ; P = 0.034 ) . The adverse effects of chemoimmunotherapy were tolerable . Advanced NSCLC patients can benefit from the combination of DC/CIK immunotherapies following conventional chemotherapy . More than two immunotherapies improved TTP and OS of those patients in this study To compare the efficacy of dendritic and cytokine-induced killer cells ( DC-CIK ) therapy combined with concurrent radiochemotherapy on stage IIIB non-small cell lung cancer . Sixty-three patients with stage IIIB non-small cell lung cancer were r and omly divided into the study and control groups . The study group , comprising 30 patients , was treated with DC-CIK combined with docetaxel-cisplatin chemotherapy and synchronization conformal radiotherapy . The control group including 33 patients was only treated with docetaxel-cisplatin chemotherapy and synchronization conformal radiotherapy . The efficacy , Karnofsky performance score ( KPS ) , tumor markers , 6-month and 12-month survival rate , T cell subsets , and adverse reactions of the two groups were compared . \n Output:\n " }, { "from": "agent", "value": "Further , carbohydrate antigen tumor markers were significantly reduced compared with the pre-therapy levels .\nImmunotherapy with CIK/DC-CIK obviously alleviated the adverse events caused by chemotherapy .\nThe combination of CIK/DC-CIK therapy and chemotherapy was superior in prolonging the survival time , enhancing immune function and alleviating the adverse events caused by chemotherapy" } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Some children allergic to cow 's milk proteins ( CMPs ) experience exceptionally severe reactions after ingesting only trace amounts of antigen . Avoiding the food and carrying self-injectable epinephrine are the current strategies for their management . OBJECTIVE The aim of this study was to evaluate the safety and efficacy of specific oral tolerance induction ( SOTI ) for children with severe CMP-induced systemic reactions . METHODS Ninety-seven children aged 5 years or older with a history of severe allergic reactions and very high CMP-specific IgE levels were selected for a double-blind , placebo-controlled food challenge . Sixty had positive test results to very small amounts of milk and were r and omly divided in 2 different groups . Thirty children ( group A ) immediately began SOTI , whereas the remaining 30 ( group B ) were kept on a milk-free diet and followed for 1 year . RESULTS After 1 year , 11 ( 36 % ) of 30 children in group A had become completely tolerant , 16 ( 54 % ) could take limited amounts of milk ( 5 - 150 mL ) , and 3 ( 10 % ) were not able to complete the protocol because of persistent respiratory or abdominal complaints . In group B the result of the double-blind , placebo-controlled food challenge performed after a year was positive in all 30 cases ( P < .001 ) . CONCLUSIONS In this study SOTI was effective in a significant percentage of cases BACKGROUND Food allergy may be life-threatening , and patients affected need to receive accurate diagnoses and treatment . Hazelnut has often been implicated as responsible for allergic reactions , and trace quantities can induce systemic reactions . OBJECTIVE The aim of this study was to evaluate the efficacy and tolerance of sublingual immunotherapy with a st and ardized hazelnut extract in patients allergic to hazelnut . METHODS This was a r and omized , double-blind , placebo-controlled study . Inclusion criteria were a history of hazelnut allergy and positive skin prick test and double-blind placebo-controlled food challenge results . Patients were then r and omly assigned into 2 treatment groups ( hazelnut immunotherapy or placebo ) . Efficacy was assessed by double-blind , placebo-controlled food challenge after 8 to 12 weeks of treatment . Blood sample s were drawn for measurement of specific IgE , IgG(4 ) , and serum cytokines before and after treatment . RESULTS Twenty-three patients were enrolled and divided into 2 treatment groups . Twenty-two patients reached the planned maximum dose at 4 days . Systemic reactions were observed in only 0.2 % of the total doses administered . Mean hazelnut quantity provoking objective symptoms increased from 2.29 g to 11.56 g ( P = .02 ; active group ) versus 3.49 g to 4.14 g ( placebo ; NS ) . Moreover , almost 50 % of patients who underwent active treatment reached the highest dose ( 20 g ) , but only 9 % in the placebo . Laboratory data showed an increase in IgG(4 ) and IL-10 levels after immunotherapy in only the active group . CONCLUSION Our data confirm significant increases in tolerance to hazelnut after sublingual immunotherapy as assessed by double-blind , placebo-controlled food challenge , and good tolerance to this treatment Background : Oral immunotherapy ( OIT ) is an effective experimental food allergy treatment that is limited by treatment withdrawal and the frequent reversibility of desensitization if interrupted . Newly diagnosed preschool children may have clinical and immunological characteristics more amenable to treatment . Objective : We sought to test the safety , effectiveness , and feasibility of early OIT ( E‐OIT ) in the treatment of peanut allergy . Methods : We enrolled 40 children aged 9 to 36 months with suspected or known peanut allergy . Qualifying subjects reacted to peanut during an entry food challenge and were block‐r and omized 1:1 to receive E‐OIT at goal maintenance doses of 300 or 3000 mg/d in a double‐blinded fashion . The primary end point , sustained unresponsiveness at 4 weeks after stopping early intervention oral immunotherapy ( 4‐SU ) , was assessed by double‐blinded , placebo‐controlled food challenge either upon achieving 4 prespecified criteria , or after 3 maintenance years . Peanut‐specific immune responses were serially analyzed . Outcomes were compared with 154 matched st and ard‐care controls . Results : Of 40 consented subjects , 3 ( 7.5 % ) did not qualify . Overall , 29 of 37 ( 78 % ) in the intent‐to‐treat analysis achieved 4‐SU ( 300‐mg arm , 17 of 20 [ 85 % ] ; 3000 mg , 12 of 17 [ 71 % ] , P = .43 ) over a median of 29 months . Per‐ protocol , the overall proportion achieving 4‐SU was 29 of 32 ( 91 % ) . Peanut‐specific IgE levels significantly declined in E‐OIT‐treated children , who were 19 times more likely to successfully consume dietary peanut than matched st and ard‐care controls , in whom peanut‐specific IgE levels significantly increased ( relative risk , 19.42 ; 95 % CI , 8.7‐43.7 ; P < .001 ) . Allergic side effects during E‐OIT were common but all were mild to moderate . Conclusions : At both doses tested , E‐OIT had an acceptable safety profile and was highly successful in rapidly suppressing allergic immune responses and achieving safe dietary re introduction BACKGROUND The mechanisms contributing to clinical immune tolerance remain incompletely understood . This study provides evidence for specific immune mechanisms that are associated with a model of operationally defined clinical tolerance . OBJECTIVE Our overall objective was to study laboratory changes associated with clinical immune tolerance in antigen-induced T cells , basophils , and antibodies in subjects undergoing oral immunotherapy ( OIT ) for peanut allergy . METHODS In a phase 1 single-site study , we studied participants ( n = 23 ) undergoing peanut OIT and compared them with age-matched allergic control subjects ( n = 20 ) undergoing st and ard of care ( abstaining from peanut ) for 24 months . Participants were operationally defined as clinical ly immune tolerant ( IT ) if they had no detectable allergic reactions to a peanut oral food challenge after 3 months of therapy withdrawal ( IT , n = 7 ) , whereas those who had an allergic reaction were categorized as nontolerant ( NT ; n = 13 ) . RESULTS Antibody and basophil activation measurements did not statistically differentiate between NT versus IT participants . However , T-cell function and demethylation of forkhead box protein 3 ( FOXP3 ) CpG sites in antigen-induced regulatory T cells were significantly different between IT versus NT participants . When IT participants were withdrawn from peanut therapy for an additional 3 months ( total of 6 months ) , only 3 participants remained classified as IT participants , and 4 participants regained sensitivity along with increased methylation of FOXP3 CpG sites in antigen-induced regulatory T cells . CONCLUSION In summary , modifications at the DNA level of antigen-induced T-cell subsets might be predictive of a state of operationally defined clinical immune tolerance during peanut OIT BACKGROUND There are presently no available therapeutic options for patients with peanut allergy . OBJECTIVE We sought to investigate the safety , efficacy , and immunologic effects of peanut sublingual immunotherapy ( SLIT ) . METHODS After a baseline oral food challenge ( OFC ) of up to 2 g of peanut powder ( approximately 50 % protein ; median successfully consumed dose [ SCD ] , 46 mg ) , 40 subjects , aged 12 to 37 years ( median , 15 years ) , were r and omized 1:1 across 5 sites to daily peanut or placebo SLIT . A 5-g OFC was performed after 44 weeks , followed by unblinding ; placebo-treated subjects then crossed over to higher dose peanut SLIT , followed by a subsequent crossover Week 44 5-g OFC . Week 44 OFCs from both groups were compared with baseline OFCs ; subjects successfully consuming 5 g or at least 10-fold more peanut powder than the baseline OFC threshold were considered responders . RESULTS After 44 weeks of SLIT , 14 ( 70 % ) of 20 subjects receiving peanut SLIT were responders compared with 3 ( 15 % ) of 20 subjects receiving placebo ( P < .001 ) . In peanut SLIT responders , median SCD increased from 3.5 to 496 mg . After 68 weeks of SLIT , median SCD significantly increased to 996 mg ( compared with Week 44 , P = .05 ) . The median SCD at the Week 44 Crossover OFC was significantly higher than baseline ( 603 vs 71 mg , P = .02 ) . Seven ( 44 % ) of 16 crossover subjects were responders ; median SCD increased from 21 to 496 mg among responders . Of 10,855 peanut doses through the Week 44 OFCs , 63.1 % were symptom free ; excluding oral-pharyngeal symptoms , 95.2 % were symptom free . CONCLUSIONS Peanut SLIT safely induced a modest level of desensitization in a majority of subjects compared with placebo . Longer duration of therapy showed statistically significant increases in the SCD BACKGROUND Cow 's milk allergy ( CMA ) in children is a important problem in medical practice . Oral desensitization has been proposed as a therapeutic approach , but current protocol s are time-consuming and impractical . OBJECTIVES To establish a patient-friendly desensitization regimen with weekly up-dosing and to evaluate it in a r and omized controlled trial . METHODS Thirty children with IgE-mediated CMA confirmed by double-blind placebo-controlled food challenge were equally r and omized to desensitization with CM or soy milk as control . The weekly up-dosing lasted 18 weeks . The occurrence and severity of reactions after each dose was evaluated , and the desensitization was stopped if severe reactions occurred . Specific IgE and IgG4 levels to CM were measured at baseline , after 8 weeks , and at the end of the study . The double-blind food challenge was repeated once the desensitization was completed or after premature discontinuation . RESULTS Two active and 1 control patient dropped out . Full tolerance to CM ( 200 mL ) was achieved in 10 active patients and partial tolerance in 1 . Two active patients discontinued the desensitization after experiencing severe reactions , whereas no reactions occurred in controls , whose sensitivity to CM remained unchanged . A significant increase in specific IgG4 levels was found only in the active group . CONCLUSIONS This weekly up-dosing desensitization protocol for CMA performed under medical supervision was effective and reasonably safe and induced consistent immunologic changes BACKGROUND Open-label oral immunotherapy ( OIT ) protocol s have been used to treat small numbers of patients with peanut allergy . Peanut OIT has not been evaluated in double-blind , placebo-controlled trials . OBJECTIVE To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind , placebo-controlled study . METHODS In this multicenter study , children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo . Initial escalation , build-up , and maintenance phases were followed by an oral food challenge ( OFC ) at approximately 1 year . Titrated skin prick tests ( SPTs ) and laboratory studies were performed at regular intervals . RESULTS Twenty-eight subjects were enrolled in the study . Three peanut OIT subjects withdrew early in the study because of allergic side effects . During the double-blind , placebo-controlled food challenge , all remaining peanut OIT subjects ( n = 16 ) ingested the maximum cumulative dose of 5000 mg ( approximately 20 peanuts ) , whereas placebo subjects ( n = 9 ) ingested a median cumulative dose of 280 mg ( range , 0 - 1900 mg ; P < .001 ) . In contrast with the placebo group , the peanut OIT group showed reductions in SPT size ( P < .001 ) , IL-5 ( P = .01 ) , and IL-13 ( P = .02 ) and increases in peanut-specific IgG(4 ) ( P < .001 ) . Peanut OIT subjects had initial increases in peanut-specific IgE ( P < .01 ) but did not show significant change from baseline by the time of OFC . The ratio of forkhead box protein 3 (FoxP3)(hi ) : FoxP3(intermediate ) CD4 + CD25 + T cells increased at the time of OFC ( P = .04 ) in peanut OIT subjects . CONCLUSION These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation . The current study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance BACKGROUND There are no treatments currently available for peanut allergy . Sublingual immunotherapy ( SLIT ) is a novel approach to the treatment of peanut allergy . OBJECTIVE We sought to investigate the safety , clinical effectiveness , and immunologic changes with SLIT in children with peanut allergy . METHODS In this double- \n Output:\n " }, { "from": "agent", "value": "Meta-analyses revealed that the risk of experiencing a systemic adverse reaction was higher in those receiving AIT , with a more marked increase in the risk of local adverse reactions .\nSensitivity analysis excluding those studies judged to be at high risk of bias demonstrated the robustness of summary estimates of effectiveness and safety of AIT for food allergy .\nAIT may be effective in raising the threshold of reactivity to a range of foods in children with IgE-mediated food allergy whilst receiving ( i.e. desensitization ) and post-discontinuation of AIT .\nIt is , however , associated with a modest increased risk in serious systemic adverse reactions and a substantial increase in minor local adverse reactions ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE To develop guidance to practicing oncologists about available fertility preservation methods and related issues in people treated for cancer . METHODS An expert panel and a writing committee were formed . The questions to be addressed by the guideline were determined , and a systematic review of the literature from 1987 to 2005 was performed , and included a search of online data bases and consultation with content experts . RESULTS The literature review found many cohort studies , case series , and case reports , but relatively few r and omized or definitive trials examining the success and impact of fertility preservation methods in people with cancer . Fertility preservation methods are used infrequently in people with cancer . RECOMMENDATIONS As part of education and informed consent before cancer therapy , oncologists should address the possibility of infertility with patients treated during their reproductive years and be prepared to discuss possible fertility preservation options or refer appropriate and interested patients to reproductive specialists . Clinician judgment should be employed in the timing of raising this issue , but discussion at the earliest possible opportunity is encouraged . Sperm and embryo cryopreservation are considered st and ard practice and are widely available ; other available fertility preservation methods should be considered investigational and be performed in centers with the necessary expertise . CONCLUSION Fertility preservation is often possible in people undergoing treatment for cancer . To preserve the full range of options , fertility preservation approaches should be considered as early as possible during treatment planning BACKGROUND Use of letrozole , a selective inhibitor of aromatase , reduces the gonadotrophin dose required to induce follicular maturation . We evaluated whether incorporation of letrozole could be an effective low-cost IVF protocol for poor responders . METHODS A r and omized , controlled , single-blind trial was conducted in the Assisted Reproduction Unit , Institute of Reproductive Medicine , Kolkata , India . Thirty-eight women with a history of poor ovarian response to gonadotrophins were recruited . Thirteen women ( Let-FSH group ) received letrozole 2.5 mg daily from day 3 - 7 , and recombinant FSH ( rFSH ) 75 IU/day on days 3 and 8 ; and 25 women ( GnRH-ag-FSH group ) underwent long GnRH agonist protocol and stimulated with rFSH ( 300 - 450 IU/day ) . Ovulation was triggered by 10,000 IU of HCG followed by IVF-embryo transfer . The main outcome measures were total dose of rFSH ( IU/cycle ) , terminal estradiol ( E2 ) ( pg/ml ) , numbers of follicles , oocytes retrieved and transferable embryo , endometrial thickness ( mm ) , and pregnancy rate . RESULTS Compared with the GnRH-ag-FSH group ( 2865 + /- 228 IU ) , the Let-FSH group ( 150 + /- 0 IU ) received a significantly ( P < 0.001 ) lower total dose of FSH . Except for terminal E2 , which was significantly higher ( P < 0.001 ) in the GnRH-ag-FSH group ( 380 + /- 46 pg/ml ) than the Let-FSH group ( 227 + /- 45 pg/ml ) , the treatment outcomes in all other respects , including pregnancy rate , were statistically comparable . CONCLUSIONS Adjunctive use of letrozole may form an effective means of low-cost IVF protocol in poorly responding women BACKGROUND Medical induction of ovulation using clomiphene citrate ( CC ) as first line and exogenous gonadotrophins as second line forms the classical treatment algorithm in normogonadotrophic anovulatory infertility . Because the chances of success following classical ovulation induction are not well established , a shift in first-line therapy can be observed towards alternative treatment . The study aim was to : ( i ) reliably assess the probability of singleton live birth following classical induction of ovulation ; and ( ii ) construct a prediction model , based on individual patient characteristics assessed upon st and ardized initial screening , to help identify patients with poor chances of success . METHODS A total of 240 consecutive women visiting a specialist academic fertility unit with a history of infertility , oligomenorrhoea or amenorrhoea , and normal FSH and estradiol serum concentrations ( WHO group 2 ) was prospect ively followed . The women had not been previously treated with ovulation-inducing agents . All patients commenced with CC . Patients who did not ovulate within three treatment cycles of incremental daily doses up to 150 mg for 5 consecutive days or ovulatory CC patients who did not conceive within six cycles , subsequently underwent gonadotrophin induction of ovulation applying a step-down dose regimen . The main outcome measure was pregnancy result ing in singleton live birth . Cox regression was used to construct a multivariable prediction model . RESULTS Overall , there were 134 pregnancies ending in a singleton live birth ( 56 % of women ) . The cumulative pregnancy rate after 12 and 24 months of follow-up was 50 % and 71 % respectively . Polycystic ovary syndrome ( PCOS ) patients ( 49 % ) , clearly non-PCOS patients ( 13 % ) and the in-between group did not differ in prognosis ( P = 0.9 ) . The multivariable Cox regression model contained the woman 's age , the insulin : glucose ratio and duration of infertility . With a cut-off value of 30 % for low chance , the model predicted probabilities at 12 months lower than this cut-off for 25 out of 240 patients ( 10.4 % ) . CONCLUSIONS Classical ovulation induction produces very good results in normogonadotrophic anovulatory infertility . Alternative treatment options may not be indicated as first-line therapy in these patients , except for subgroups with poor prognosis . These women can be identified by older age , longer duration of infertility and higher insulin : glucose ratio OBJECTIVE To determine the serum concentrations of enclomiphene and zuclomiphene across consecutive cycles of clomiphene citrate treatment in anovulatory infertile women . DESIGN Prospect i ve cohort . SETTING Tertiary institutional infertility clinic . PATIENT(S ) Fourteen consenting anovulatory infertile women receiving st and ardized , cyclic , incremental treatment with clomiphene citrate for ovulation induction . INTERVENTION(S ) Clomiphene citrate treatment ( 50 - 150 mg/d , cycle days 5 - 9 ) , titrated to the minimum effective ovulation-inducing dose , was administered for three to six total cycles . Blood sample s were obtained on cycle days 3 and 10 in each treatment cycle . MAIN OUTCOME MEASURE(S ) Serum concentrations of enclomiphene and zuclomiphene . RESULT ( S ) Cycle day 3 zuclomiphene levels were below assay limits in all initial cycles , increased progressively across three consecutive cycles , and thereafter plateaued . Cycle day 3 enclomiphene concentrations were uniformly undetectable . Cycle day 10 enclomiphene levels increased with dose administered , but these observations were not statistically significant . CONCLUSION ( S ) Clomiphene citrate induction of ovulation results in an isomer-specific systemic accumulation of zuclomiphene across consecutive cycles of treatment . The combined maximum concentration of enclomiphene and zuclomiphene attained in practice approximates 100 nmol/L and is generally well below levels previously demonstrated to have adverse effects in vitro Letrozole was compared with clomiphene citrate ( CC ) as a first-line treatment for ovulation induction in women with polycystic ovaries ( PCOs ) . A total of 106 women with primary infertility and a diagnosis of PCOs were r and omized to receive either 100 mg CC ( n = 55 ) or 2.5 mg letrozole ( n = 51 ) daily for 5 days . Human chorionic gonadotrophin ( hCG ) at a dose of 10 000 IU was administered when at least one follicle with a mean diameter ≥ 18 mm was observed using transvaginal ultrasound . The number of mature follicles was significantly lower , but endometrial thickness and ovulation and pregnancy rates were significantly higher in the letrozole group than in the CC group . In conclusion , letrozole is associated with a higher pregnancy rate than CC in PCO patients and may have a role as a first-line treatment for anovulatory patients with PCOs BACKGROUND To compare the clinical results and the cost-effectiveness of using the aromatase inhibitor , letrozole , in conjunction with FSH and FSH alone for controlled ovarian stimulation ( COS ) in patients undergoing intrauterine insemination ( IUI ) for a variety of indications . METHODS Four hundred and thirty-two consecutive patients who underwent 872 IUI cycles were included . The study population was composed of two groups . Group I included 308 patients who underwent 589 IUI cycles with letrozole and FSH for the following indications : anovulation ( 143 cycles ) , male factor infertility ( 147 cycles ) , unexplained infertility ( 250 cycles ) , endometriosis ( 18 cycles ) and combined indications ( 31 cycles ) . Group II included 124 patients who underwent 283 IUI cycles who received FSH only for the following indications : ovarian factor infertility ( 82 cycles ) , male factor infertility ( 66 cycles ) , unexplained infertility ( 114 cycles ) , endometriosis ( 13 cycles ) and other indications ( 8 cycles ) . Main outcome measures included number of mature follicles > 16 mm in diameter , dose of FSH used per cycle , clinical pregnancy rate and cost-effectiveness ratio per pregnancy . RESULTS FSH dose required for ovarian stimulation was significantly lower when letrozole was used ( P < 0.0001 ) . Although a significantly higher number of follicles > 16 mm and endometrial thickness at the day of hCG administration ( P < 0.0001 ) were observed in Group II , pregnancy rate per started ( 14.4 versus 15.9 % ) and per completed cycles ( 15.77 versus 18.07 % ) was the same in Group I and Group II , respectively . IUI cancellation rate was significantly lower with letrozole treatment ( P = 0.05 % ) . The cost per cycle was significantly lower in Group I versus Group II ( 468.93 Can dollars + /- 418.18 versus 1067.28 + /- 921.43 ; P < 0.0001 ) . The cost-effectiveness ratio was 3249.42 dollars in the letrozole group and 6712.00 dollars in the FSH-only group . CONCLUSION A letrozole-FSH combination could be an effective ovarian stimulation protocol in IUI cycles . Such a protocol may be more cost-effective than FSH alone because of the difference of FSH dose and cost . A r and omized controlled trial is needed to further substantiate this finding OBJECTIVE To study the effects of clomiphene citrate ( CC ) on the endometrium of regularly cycling women . DESIGN Prospect i ve , controlled study . SETTING Department of Obstetrics and Gynaecology , Faculty of Medicine , Chulalongkorn University , Bangkok , Thail and . PATIENT(S ) Thirty healthy , regularly cycling , female volunteers . INTERVENTION(S ) All volunteers were studied for two consecutive cycles , one control cycle and one CC-treated cycle . Clomiphene citrate ( 100 mg/d ) was given on days 3 - 7 of the CC-treated cycles . Ultrasonography was performed daily to assess ovulation . Ultrasonography and endometrial biopsy were performed , and blood sample s were obtained for determination of E2 and progesterone levels 7 days after ovulation in both the control and CC-treated cycles . MAIN OUTCOME MEASURE(S ) Histologic dating , morphometric analysis , and ultrasonographic appearance and thickness of the endometrium . RESULT ( S ) Histologic dating and ultrasonographic appearance and thickness of the endometrium were similar in the control and CC-treated cycles , but morphometric parameters were different . The number of gl and s per square millimeter and the mean diameter of the gl and s were lower in the CC-treated cycles than in the control cycles , but the number of vacuolated cells per 1,000 gl and ular cells was higher . CONCLUSION ( S ) Clomiphene citrate has effects on the endometrium of regularly cycling women , as demonstrated by a reduction in gl and ular density and an increase in the number of vacuolated cells OBJECTIVE To evaluate the ovarian follicular dynamics of cycle modification with the aromatase inhibitor letrozole compared with clomiphene citrate in normal ovulatory women . DESIGN R and omized double-blind controlled trial . SETTING Tertiary care hospital . PATIENT(S ) Nineteen ovulatory female volunteers , ages 18 - 35 years . INTERVENTION(S ) Subjects were monitored in one control cycle . Subjects then received either letrozole 2.5 mg daily or clomiphene citrate 50 mg daily on days 5 - 9 after menses . MAIN OUTCOME MEASURE(S ) Number of mature follicles , endometrial thickness and endometrial pattern at ovulation , and follicular profiles of LH , FSH , and E(2 ) . RESULT ( S ) The number of mature follicles at the LH surge in natural cycles was 1.0 with an exaggerated response seen for treatment both with clomiphene and letrozole . There was no difference in the endometrial thickness at midcycle during either the natural cycles or the medicated cycles . LH surges and \n Output:\n " }, { "from": "agent", "value": "CONCLUSIONS Letrozole is as effective as other methods of ovulation induction ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background Roux-en-Ygastric bypass ( RYGB ) and sleeve gastrectomy ( SG ) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation . A systematic review revealed a similar excess weight loss ( EWL ) 2 years postoperatively between SG and RYGB . However , there is a lack of r and omized controlled multi-centre trials comparing SG and RYGB , not only concerning EWL , but also in terms of remission of obesity-related co-morbidities , gastroesophageal reflux disease ( GERD ) and quality of life ( QoL ) in the mid- and long-term . Methods The BariSurg trial was design ed as a multi-centre , r and omized controlled patient and observer blind trial . The trial protocol was approved by the corresponding ethics committees of the centres . To demonstrate EWL non-inferiority of SG compared to RYGB , power calculation was performed according to a non-inferiority study design . Morbidity , mortality , remission of obesity-related co-morbidities , GERD course and QoL are major secondary endpoints . 248 patients between 18 and 70 years , with a body mass index ( BMI ) between 35–60 kg/m2 and indication for bariatric surgery according to the most recent German S3- guidelines will be r and omized . The primary and secondary endpoints will be assessed prior to surgery and afterwards at discharge and at the time points 3–6 , 12 , 24 , 36 , 48 and 60 months postoperatively . Discussion With its five year follow-up , the BariSurg-trial will provide further evidence based data concerning the impact of SG and RYGB on EWL , remission of obesity-related co-morbidities , the course of GERD and QoL.Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004766 Objective : To present long-term results of a large series of patients su bmi tted to laparoscopic Roux-en-Y gastric bypass ( RYGBP ) for morbid obesity . Background : Reports on long-term results of RYGBP are scarce and focus primarily on weight loss . Our aim is to provide mid- to long-term data of RYGBP , with detailed results on weight loss , evolution of comorbidities and quality of life , also using the BAROS score . Methods : All patients who underwent a primary RYGBP for morbid obesity in our 2 hospitals between 1999 and August 2008 were included . Data were collected prospect ively in a computerized data base , and review ed for the purpose of this study . Results : A total of 379 patients were included in the analysis of long-term results , 282 women , and 97 men , with a mean BMI of 46.3 kg/m2 . After 5 years , 74.9 % of the patients achieved an excess weight loss of at least 50 % , with a mean of 62.7 % and 76.8 % achieved a BMI < 35 kg/m2 . The corresponding figures after 7 years were 64.9 , 58.1 , and 71.9 , respectively . There was a small but significant long-term weight regain . All comorbidities improved markedly in the vast majority of patients , with no significant difference between the 3- and 5-year terms . Quality of life also improved markedly , and more than 95 % of the patients had a good to excellent 5-year overall result according to the BAROS score . Conclusions : Laparoscopic RYGBP for morbid obesity results in good and maintained weight loss up to 7 years in the majority of patients , improves quality of life and markedly improves all the evaluated comorbidities , result ing in good to excellent overall 5-year results in 97 % of the patients according to the BAROS score Background Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) is currently the gold st and ard bariatric procedure for the treatment of morbid obesity . Laparoscopic sleeve gastrectomy ( LSG ) is a relatively innovative procedure which has been increasingly applied lately as a sole bariatric procedure . A r and omized trial was conducted in a Greek population to evaluate perioperative safety and 3-years results . Methods Sixty patients with body mass index ( BMI ) ≤ 50 Kg/m2 were r and omized to LRYGB or LSG . Patients were monitored for 3 years postoperatively and throughout the study period weight loss , in terms of percent excess weight loss ( % EWL ) , early and late complications , improvement of obesity related comorbidities and nutritional deficiencies were compared between groups . Results There was no death in either group and there was no significant difference in early ( 10 % after LRYGB and 13 % after LSG , P > 0.05 ) and late morbidity ( 10 % in each group ) . Weight loss was significantly better after LSG in the first years of the study and at 3 years % EWL reached 62 % after LRYGB and 68 % after LSG ( p = 0.13 ) . There was no significant difference in the overall improvement of comorbidities . Nutritional deficiencies occurred at the same rate in the two groups except to vitamin B12 deficiency which was more common after LRYGB ( P = 0.05 ) . Conclusion LSG and LRYGB are equally safe and effective in the amelioration of comorbidities , while LSG is associated with fewer postoperative metabolic deficiencies , without the need of supplementation . Furthermore , LSG is a promising bariatric procedure , equally effective to LRYGB at 3 years follow up on weight reduction Aims /hypothesisBariatric surgery is gaining acceptance as a ‘ metabolic surgical intervention ’ for patients with type 2 diabetes . The optimal form of surgery and the mechanism of action of these procedures are much debated . We compared two bariatric procedures for obese patients with type 2 diabetes and evaluated their effects on HbA1c and glucose tolerance . Methods We performed a parallel un-blinded r and omised trial of Roux-en-Y gastric bypass ( RYGB ) vs sleeve gastrectomy ( SG ) in 41 obese patients with type 2 diabetes , who were bariatric surgery c and i date s attending the obesity clinic . HbA1c , body composition and glucose tolerance were evaluated at baseline , and at 3 and 12 months . Results Of the 41 patients , 37 completed the follow-up ( 19 RYGB , 18 SG ) . Both groups had similar baseline anthropometric and biochemical measures , and showed comparable weight loss and fat : fat-free mass ratio changes at 12 months . A similar normalisation of HbA1c levels was observed as early as 3 months post-surgery ( 6.37 ± 0.71 % vs 6.23 ± 0.69 % for RYGB vs SG respectively , p < 0.001 in both groups for baseline vs follow-up ) . Conclusions /interpretationIn this study , RYGB did not have a superior effect in comparison to SG with regard to HbA1c levels or weight loss during 12 months of follow-up . Trial registration Clinical Trials.gov NCT00667706 Funding This work was supported by grant no. 3 - 000 - 8480 from the Israel Ministry of Health Chief Scientist , the Stephen Morse Diabetes Research Foundation and by Johnson & Johnson Background Obesity is an increasing disease worldwide . Bariatric surgery is the only effective therapy to induce sufficient long-term weight loss for morbidly obese patients . Laparoscopic Roux-en-Y Gastric Bypass ( LRYGB ) is the gold st and ard surgical technique . Laparoscopic Sleeve Gastrectomy ( LSG ) is a new promising bariatric procedure which has the advantage of maintaining an intact gastrointestinal tract . The aim of this study is to evaluate the efficiency of both techniques . Our hypothesis is that LSG has a similar percentage excess BMI loss ( % E BMI L ) after 5 years compared to LRYGB . Methods / Design The Sleeve Bypass Trial is a r and omized multicentre clinical trial : patients eligible for bariatric surgery are r and omized to either LSG or LRYGB . Patients with a body mass index ( BMI ) ≥ 40 kg/m2 or BMI 35 kg/m2 with obesity related comorbidity ( T2 DM , sleep apnoea , hypertension ) are eligible for r and omization . At r and omization patients are stratified for centre , sex , T2 DM and BMI ≥ 50 kg/m2 . A total number of 620 patients will be enrolled and equally ( 1:1 ) r and omized to both treatment arms . Only surgeons experienced in both operation techniques will participate in the Sleeve Bypass trial . The primary endpoint is the 5-year weight loss ( % E BMI L ) of LSG and LRYGB . Secondary endpoints are resolution of obesity related comorbidity , complications , revision bariatric surgery and quality of life ( QOL ) defined in various question naires . Discussion Long-term % E BMI L between the two treatment strategies used to be in favour of LRYGB , but more recent results throughout the world show similar % E BMI L in both techniques . If weight loss is comparable , obesity-related comorbidity and QOL after bariatric procedures should be taken into account when deciding on which surgical technique is to be preferred for certain subgroups in the future . Trial registration Dutch Trial Register : NTR 4741 Context Observational studies have shown sustained weight loss after surgery for extreme obesity . No r and omized trial of contemporary surgical methods has been performed . Contribution The authors r and omly assigned 80 mildly to moderately obese ( body mass index , 30 to 35 kg/m2 ) adults to laparoscopic placement of an adjustable gastric b and or to an intensive nonsurgical weight loss program . After 2 years , the surgical group had lost 21.6 % of initial weight , and the nonsurgical group had lost 5.5 % of initial weight . Four patients required laparoscopic revision of the gastric b and . Caution s The study was not design ed to detect uncommon adverse events . Implication s Laparoscopic gastric b and ing is effective treatment for mild to moderate obesity . The Editors The development of a safe and effective treatment for obesity is a leading challenge in health care today . Obesity is an increasing health problem across the world with a prevalence of more than 20 % among the adult population in Western countries and more than 30 % in the United States ( 1 , 2 ) . The increasing prevalence is associated with a parallel increase of several obesity-related diseases , in particular , the diseases of the metabolic syndrome ( 3 , 4 ) , which include type 2 diabetes , hypertension , and dyslipidemia , and are linked to nonalcoholic steatohepatitis , obstructive sleep apnea , and the polycystic ovary syndrome . For obese individuals , the options are limited . Behavioral therapies of reduced energy intake , improved eating practice s , and increased exercise and activity , supplemented by pharmacotherapy , generally achieve only modest and often transient effects ( 5 , 6 ) . Observational studies have shown that bariatric surgical therapies involving gastric restriction by various forms of stapling with or without diversion of the gut to generate malabsorption of food are effective in achieving major weight loss and clinical ly significant improvements in health and quality of life ( 7 - 11 ) . Strong direct evidence from r and omized , controlled trials of the relative benefits of nonsurgical and surgical therapies is lacking . We are aware of only a single study , performed in the 1980s , in which 60 morbidly obese patients were r and omly assigned , without informed consent , to diet plus an early form of gastric stapling or to diet alone ( 12 ) . The maximum weight losses did not differ between the groups . However , the weight regain was greater in the diet-only group . The advent of the laparoscopic adjustable gastric b and has provided a new bariatric surgical option , which has proved to be safe , minimally invasive in its application , gentle in its use through its adjustability and easy reversibility , and similarly effective to the other bariatric procedures ( 10 , 13 , 14 ) . Figure 1 shows the LAP-B AND System ( INAMED Health , Santa Barbara , California ) and demonstrates the key feature of adjustability of the area within the b and through which it induces satiety ( 15 ) . Patients require no more than an overnight hospital stay , and the procedure has been shown to be markedly safer than gastric bypass surgery ( 13 ) . Figure 1 . The laparoscopic adjustable gastric b and ( LAP-B AND System , INAMED Health , Santa Barbara , California ) with no added fluid ( top ) and with 2 mL of fluid added ( bottom ) . We hypothesized that surgical therapy would induce more weight loss , health benefit , and improvement in quality of life than nonsurgical therapy and have conducted a r and omized , controlled trial comparing the effectiveness of current nonsurgical therapy with laparoscopic adjustable gastric b and ing in a group of mildly to moderately obese adults ( body mass index , 30 kg/m2 to 35 kg/m2 ) . We did not study patients with a body mass index greater than 35 kg/m2 because current observational data suggest that outcomes after nonsurgical treatment were unlikely to be equal to those after surgical care for these patients . The principal outcome measures were weight change , health , quality of life , and complications of therapy . Methods Patient Recruitment We recruited patients for the study through a newspaper advertisement . All patient assessment s and outpatient treatments were conducted at a \n Output:\n " }, { "from": "agent", "value": "Conclusions This systematic review of RCTs suggests that both LVSG and LRYGB are effective in resolving or improving preoperative type 2 diabetes in obese patients during the reported 3- to 5-year follow-up periods ." } ]

[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: PURPOSE The study assesses potential for improving residents ' evidence -based medicine search ing skills in MEDLINE through real-time librarian instruction . SUBJECTS Ten residents on a rotation in a neonatal intensive care unit participated . METHODOLOGY Residents were r and omized into an instruction and a non-instruction group . Residents generated questions from rounds and search ed MEDLINE for answers . Data were collected through observation , search strategy analysis , and surveys . Librarians observed search es and collected data on questions , search ing skills , search problems , and the test group 's instruction topics . Participants performed st and ardized search es before , after , and six-months after intervention and were scored using a search strategy analysis tool ( 1 representing highest score and 5 representing lowest score ) . Residents completed pre- and post-intervention surveys to measure opinions about MEDLINE and search satisfaction . RESULTS Post-intervention , the test group formulated better questions , used limits more effectively , and reported greater confidence in using MEDLINE . The control group expressed less satisfaction with retrieval and demonstrated more errors when limiting . The test and control groups had the following average search scores respectively : 3.0 and 3.5 ( pre-intervention ) , 3.3 and 3.4 ( post-intervention ) , and 2.0 and 3.8 ( six-month post-intervention ) . CONCLUSION Data suggest that measurable learning outcomes were achieved . Residents receiving instruction improved and retained search ing skills six-months after intervention BACKGROUND AND OBJECTIVES Medical education experts have called for improved training in evidence -based medicine ( EBM ) and the increased use of e-learning technologies in medical education . In response , we developed an interactive , Web-based curriculum on key aspects of EBM in family medicine . METHODS Students participating in a 6-week family medicine clerkship ( n=238 ) were r and omly assigned to intervention ( n=134 ) or control ( n=104 ) groups . Both groups participated in the traditional clerkship experience , but intervention group students received additional training via an on-line curriculum that included learning modules in MEDLINE search ing skills , EBM skills , and the calculation of the number needed to treat ( NNT ) statistic . The on-line curriculum was evaluated using a case-control design with a test case at the clerkship 's end . RESULTS Results suggested that the on-line curriculum was effective , with experimental group students outperforming control group participants on a variety of measures , including the number of MEDLINE search es conducted during the clerkship ( 13 search es versus 3 search es ) and the quality of literature search strategies on an evaluation patient case study ( 2.9 versus 2.1 on a 1=poor to 4=excellent scale ) . Intervention group students reported greater confidence and enjoyment in search ing the biomedical journal literature via MEDLINE and were more likely to identify the best articles ( r and omized controlled trials or meta-analyses ) for the evaluation case from among those retrieved ( 60 % versus 34 % ) . In addition , intervention group students ' abilities to correctly calculate the NNT were significantly higher than those of control group participants ( 73 % versus 27 % ) . Intervention group students were more likely than control subjects to report learning from other students during the clerkship . CONCLUSIONS This study demonstrates that an e-learning approach to educating medical students to effectively search MEDLINE for articles meeting the criteria for evidence -based practice can result in higher- quality literature search strategies , identification of higher- quality evidence , and improved confidence in information retrieval and analysis skills Background Evidence -based medicine ( EBM ) has been widely integrated into residency curricula , although results of r and omized controlled trials and long term outcomes of EBM educational interventions are lacking . We sought to determine if an EBM workshop improved internal medicine residents ' EBM knowledge and skills and use of secondary evidence re sources . Methods This r and omized controlled trial included 48 internal medicine residents at an academic medical center . Twenty-three residents were r and omized to attend a 4-hour interactive workshop in their PGY-2 year . All residents completed a 25-item EBM knowledge and skills test and a self-reported survey of literature search ing and re source usage in their PGY-1 , PGY-2 , and PGY-3 years . Results There was no difference in mean EBM test scores between the workshop and control groups at PGY-2 or PGY-3 . However , mean EBM test scores significantly increased over time for both groups in PGY-2 and PGY-3 . Literature search es , and re source usage also increased significantly in both groups after the PGY-1 year . Conclusions We were unable to detect a difference in EBM knowledge between residents who did and did not participate in our workshop . Significant improvement over time in EBM scores , however , suggests EBM skills were learned during residency . Future rigorous studies should determine the best methods for improving residents ' EBM skills as well as their ability to apply evidence during clinical practice BACKGROUND Librarians at the University of Alberta have been involved with teaching undergraduate medical and dental education for several years . After 1 year of increased librarian involvement at the problem-based learning ( PBL ) , small-group level , informal feedback from faculty and students suggested that librarians ' participation in PBL groups was beneficial . There was , however , no real evidence to support this cl aim or justify the high dem and on librarians ' time . OBJECTIVES The study aim ed to determine whether having a librarian present in the small-group , problem-based learning modules for first-year medical and dental students results in an improved underst and ing of evidence -based medicine concepts , the nature of medical literature , and information access skills . METHODS One hundred and sixty-four first-year medical and dental students participated in the study . There were a total of 18 PBL groups , each with approximately nine students and one faculty tutor . Six librarians participated and were assigned r and omly to the six intervention groups . Students were given pre- and post-tests at the outset and upon completion of the 6-week course . RESULTS Post-test scores showed that there was a small positive librarian impact , but final exam scores showed no impact . There was also no difference in attitudes or comfort levels between students who had a librarian in their group and those who did not . CONCLUSIONS Impact was not sufficient to warrant continued participation of librarians in PBL . In future instruction , librarians at the John W. Scott Health Sciences Library will continue to teach at the larger group level Purpose Many educational programs seek to develop skills in evidence -based medicine ( EBM ) . The authors examined the efficacy of teaching the EBM skill of efficiently search ing the research literature . They compared students who received brief training in EBM search ing skills with those who did not , and assessed the quality of literature search ing one month after that training . Method The authors used a nonr and omized control group study design to quantify the impact of a single , brief ( two-hour ) instructional intervention on EBM-based techniques for search ing Medline for evidence related to a clinical problem provided to the students . Ninety-two fourth-year medical students ( 34 intervention , 58 control ) at the University of Michigan participated in a four-week EBM elective between 2001 and 2003 . The authors conducted a preintervention assessment of search ing skills , followed by a repeat assessment one month after the intervention . Search quality was judged by medical librarians using a structured clinical scenario and scoring algorithm . Results Data for 30 intervention and 40 control students could be analyzed . Intervention students had fewer search errors and correspondingly higher quality search es than did control students . The educational intervention accounted for approximately 8 % of the variance in both of these outcomes . The most common search errors were a lack of Medical Subject Headings ( MeSH ) explosion , missing MeSH terms , lack of appropriate limits , failure to search for best evidence , and inappropriate combination of all search concepts . Conclusions This study provides evidence that a single , brief training session can have a marked beneficial effect on the quality of subsequent , short-term EBM literature search ing performance outcomes OBJECTIVES Constructing an answerable question and effectively search ing the medical literature are key steps in practicing evidence -based medicine ( EBM ) . This study aim ed to identify the effectiveness of delivering a single workshop in EBM literature search ing skills to medical students entering their first clinical years of study . METHODS A r and omized controlled trial was conducted with third-year undergraduate medical students . Participants were r and omized to participate in a formal workshop in EBM literature search ing skills , with EBM literature search ing skills and perceived competency in EBM measured at one-week post-intervention via the Fresno tool and Clinical Effectiveness and Evidence -Based Practice Question naire . RESULTS A total of 121 participants were enrolled in the study , with 97 followed-up post-intervention . There was no statistical mean difference in EBM literature search ing skills between the 2 groups ( mean difference = 0.007 ( P = 0.99 ) ) . Students attending the EBM workshop were significantly more confident in their ability to construct clinical questions and had greater perceived awareness of information re sources . CONCLUSIONS A single EBM workshop did not result in statistically significant changes in literature search ing skills . Teaching and reinforcing EBM literature search ing skills during both pre clinical and clinical years may result in increased student confidence , which may facilitate student use of EBM skills as future clinicians BACKGROUND Considerable barriers still prevent paediatricians from successfully using information retrieval technology . OBJECTIVES To verify whether the assistance of biomedical librarians significantly improves the outcomes of search es performed by paediatricians in biomedical data bases using real-life clinical scenarios . METHODS In a controlled trial at a paediatric teaching hospital , nine residents and interns were r and omly allocated to an assisted search group and nine to a non-assisted ( control ) group . Each participant search ed PubMed and other online sources , performing pre-determined tasks including the formulation of a clinical question , retrieval and selection of bibliographic records . In the assisted group , participants were supported by a librarian with ≥5 years of experience . The primary outcome was the success of search sessions , scored against a specific assessment tool . RESULTS The median score of the assisted group was 73.6 points interquartile range ( IQR = 13.4 ) vs. 50.4 ( IQR = 17.1 ) of the control group . The difference between median values in the results was 23.2 points ( 95 % CI 4.8 - 33.2 ) , in favour of the assisted group ( P-value , Mann-Whitney U test : 0.013 ) . CONCLUSIONS The study has found quantitative evidence of a significant difference in search performance between paediatric residents or interns assisted by a librarian and those search ing the literature alone Background To practice Evidence -Based Medicine ( EBM ) , physicians must quickly retrieve evidence to inform medical decisions . Internal Medicine ( IM ) residents receive little formal education in electronic data base search ing , and have identified poor search ing skills as a barrier to practicing EBM . Objective To design and implement a data base search ing tutorial for IM residents on inpatient rotations and to evaluate its impact on residents ’ skill and comfort search ing MEDLINE and filtered EBM re sources . Design R and omized controlled trial . Residents r and omized to the search ing tutorial met for up to 6 1-hour small group sessions to search for answers to questions about current hospitalized patients . Participants Second- and 3rd-year IM residents . Measurements Residents in both groups completed an Objective Structured Search ing Evaluation ( OSSE ) , search ing for primary evidence to answer 5 clinical questions . OSSE outcomes were the number of successful search es , search times , and techniques utilized . Participants also completed self- assessment surveys measuring frequency and comfort using EBM data bases . Results During the OSSE , residents who participated in the intervention utilized more search ing techniques overall ( p < .01 ) and used PubMed ’s Clinical Queries more often ( p < .001 ) than control residents . Search ing “ success ” and time per completed search did not differ between groups . Compared with controls , intervention residents reported greater comfort using MEDLINE ( p < .05 ) and the Cochrane Library ( p < .05 ) on post-intervention surveys . The groups did not differ in comfort using ACP Journal Club , or in self-reported frequency of use of any data bases . Conclusions An inpatient EBM search ing tutorial improved search ing techniques of IM residents and result ed in increased comfort with MEDLINE and the Cochrane Library , but did not impact overall search ing success OBJECTIVE To examine the evidence that the teaching of critical appraisal ( evidence -based medicine ) skills to undergraduate medical students or residents will result in significant gains in knowledge and increased use of the literature in clinical decision-making . DATA SOURCES Articles published from 1966 to 1995 , retrieved through a MEDLINE search supplemented by manual search es ; review of bibliographies maintained by individuals involved in teaching critical appraisal skills ; and a previous method ological review . STUDY SELECTION Articles were selected if the study involved some form of control group , although strict r and omization was not required , and a measure of performance followed the intervention . Articles were excluded if they simply reported the process of teaching critical appraisal skills or used some form of \" happiness index . \" DATA SYNTHESIS There were 10 studies of the impact of teaching critical appraisal skills , 6 involving medical students and 4 involving residents . Results from 3 of the studies were nearly uninterpretable and thus were excluded ; the remaining 7 were method ologically acceptable . Analysis showed that interventions implemented in undergraduate programs result ed in significant gains in knowledge , as assessed by a written test ( mean gain 17.0 % ; st and ard deviation [ SD ] 4.0 % ) . Conversely , studies at the residency level consistently showed a small change in knowledge ( mean gain 1.3 % ; SD 1.7 % ) . Two studies that examined residents ' use of the literature were unable to demonstrate any positive changes . CONCLUSIONS Studies of the effect of teaching critical appraisal skills on gains in knowledge at the undergraduate level showed consistent improvement . By contrast , changes in knowledge at the residency level were small . Several suggestions from the educational literature are offered to increase effectiveness \n Output:\n " }, { "from": "agent", "value": "DISCUSSION Findings were weakly significant for positive change in search performance for most studies ." } ]