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Comparison of four continuously administered progestogen plus oestradiol combinations for climacteric complaints . Sixty women with climacteric complaints who had not menstruated for at least 1 year were randomly allocated to receive one of four hormonal replacement regimens . All four formulations were administered daily and continuously and each contained 2 mg of micronized oestradiol-17 beta in combination with either norethisterone acetate 1 mg ( group A ) or 0.5 mg ( group B ) or megestrol acetate 5 mg ( group C ) or 2.5 mg ( group D ) . The clinical efficacy was the same although the alleviation of vasomotor symptoms was somewhat slower in those women receiving preparation A . The endometrium was atrophied in nearly all biopsies . Irregular uterine bleeding was almost entirely confined to the earlier phase of the study and was substantially less with the formulation containing 1 mg norethisterone acetate . It is concluded that a continuous oestradiol-progestogen combination can be used for long-term treatment of climacteric complaints in postmenopausal women and that after 4 months the clinical efficacy is the same irrespective of the type and dose of progestogen administered .
{ "P": [ "Sixty", "not menstruated" ], "I": [ "progestogen plus oestradiol", "micronized oestradiol-17 beta in combination with either norethisterone acetate 1 mg", "or megestrol acetate 5 mg", "norethisterone acetate", "oestradiol-progestogen combination", "progestogen" ], "O": [ "climacteric complaints .", "clinical efficacy", "vasomotor symptoms", "endometrium", "biopsies .", "Irregular", "uterine", "bleeding", "climacteric complaints" ] }
Evaluation of a device to facilitate female urethral catheterization . Urethral catheterization is a skilled procedure that nurses in hospital settings perform routinely . The opening of the female urethra is located within the vulvar vestibule , making insertion of urinary catheters into females a greater technical challenge than in males . Researchers evaluated whether a new device might decrease the time required for catheter insertion , increase the likelihood of inserting the catheter on the first attempt ( improved accuracy ) , and reduce patient discomfort . Comments about the device from both patients and nurses also are reported .
{ "P": [ "female", "females" ], "I": [ "device to facilitate female urethral catheterization", "Urethral catheterization" ], "O": [ "Evaluation", "time required for catheter insertion", "increase the likelihood of inserting the catheter on the first attempt ( improved accuracy )", "reduce patient discomfort" ] }
[ Effects of small needle-knife comprehensive therapy on pain and lumbar flexion range in the chronic nonspecific low back pain patient ] . OBJECTIVE To observe therapeutic effect of small needle-knife comprehensive therapy on pain and lumbar flexion range in the chronic nonspecific low back pain patient . METHODS Three hundred and five cases were randomly divided into a needle-knife group of 153 cases and a physiotherapy group of 152 cases . The needle-knife group were treated with small needle-knife releasing therapy , blocking and functional training . The physiotherapy group were treated with ultra-short wave , modulated medium frequency current , massage and functional training . Pain was assessed by visual analogue scale ( VAS ) and the lumbar flexion range was determined before and after treatment . RESULTS After treatment , the pain and the lumbar flexion range were significantly improved in the two groups ; and after treatment , the VAS score and the lumbar flexion range were ( 1.60 +/- 0.38 ) points and ( 65.76 +/- 15.11 ) cm in the needle-knife group and ( 4.59 +/- 1.09 ) points and ( 53.74 +/- 15.13 ) cm in the physiotherapy group , respectively , the needle-knife group being significantly better than the physiotherapy group ( P < 0.01 ) . Follow-up survey of 6-36 months showed that the VAS score and the lumbar flexion range in the needle-knife group were superior to those in the physiotherapy group . CONCLUSION Small needle-knife comprehensive therapy can significantly improve pain and lumbar flexion range in the chronic nonspecific low back pain patient , with a stable long-term therapeutic effect .
{ "P": [ "chronic nonspecific low back pain", "Three hundred and five" ], "I": [ "small needle-knife comprehensive therapy", "needle-knife", "physiotherapy", "blocking and functional training", "ultra-short wave", "modulated medium frequency current", "massage and functional training", "Small needle-knife comprehensive therapy" ], "O": [ "pain", "lumbar flexion range", "Pain", "visual analogue scale ( VAS", "VAS score" ] }
Biventricular pacing improves cardiac function and prevents further left atrial remodeling in patients with symptomatic atrial fibrillation after atrioventricular node ablation . BACKGROUND Randomized trials have demonstrated benefits of biventricular ( BiV ) pacing in patients with advanced heart failure , intraventricular conduction delay , and atrial fibrillation ( AF ) post-atrioventricular ( AV ) node ablation . The AV Node Ablation with CLS and CRT Pacing Therapies for Treatment of AF trial ( AVAIL CLS/CRT ) was designed to demonstrate superiority of BiV pacing in patients with AF after AV node ablation , to evaluate its effects on cardiac structure and function , and to investigate additional benefits of Closed Loop Stimulation ( CLS ) ( BIOTRONIK , Berlin , Germany ) . METHODS Patients with refractory AF underwent AV node ablation and were randomized ( 2:2:1 ) to BiV pacing with CLS , BiV pacing with accelerometer , or right ventricular ( RV ) pacing . Echocardiography was performed at baseline and 6 months , with paired data available for 108 patients . RESULTS The RV pacing contributed to significant increase in left atrial volume , left ventricular ( LV ) end-systolic volume , and LV mass compared to BiV pacing . Ejection fraction decreased insignificantly with RV pacing compared to significant increase with BiV pacing . Interventricular dyssynchrony significantly decreased with BiV compared with RV pacing . Closed Loop Stimulation did not result in additional echocardiographic changes ; heart rate distribution was significantly wider with CLS . All groups showed significant improvement in 6-minute walk distance , quality-of-life score , and New York Heart Association class . CONCLUSION In conclusion , RV pacing results in significant increase in left atrial volume , LV mass , and worsening of LV contractility compared to patients receiving BiV pacing post-AV node ablation for refractory AF . Closed Loop Stimulation was not associated with additional structural changes but resulted in significantly wider heart rate distribution .
{ "P": [ "symptomatic atrial fibrillation", "advanced heart failure", "intraventricular conduction delay ,", "atrial fibrillation ( AF ) post-atrioventricular ( AV ) node ablation", "AF", "108" ], "I": [ "biventricular ( BiV ) pacing", "BiV pacing with CLS , BiV pacing with accelerometer , or right ventricular ( RV ) pacing" ], "O": [ "cardiac function", "left atrial remodeling", "left atrial volume , left ventricular ( LV ) end-systolic volume , and LV mass", "Ejection fraction", "Interventricular dyssynchrony", "echocardiographic changes", "heart rate distribution", "6-minute walk distance", "quality-of-life score", "New York Heart Association class", "left atrial volume", "worsening of LV contractility", "structural changes", "wider heart rate distribution" ] }
Effects of the cholinomimetic SDZ ENS-163 on scopolamine-induced cognitive impairment in humans . Scopolamine-induced cognitive impairment was used in healthy men to evaluate the central nervous system activity of the new cholinomimetic SDZ ENS-163 . Eighteen subjects were treated in a crossover design with oral placebo/intravenous saline , 50 mg of oral SDZ ENS-163/intravenous saline , oral placebo/0.4 mg of intravenous scopolamine , and 50 mg of oral SDZ ENS-163/0.4 mg of intravenous scopolamine . The administration of placebo with scopolamine caused significant cognitive impairment , as assessed by the Computerized Neuropsychological Test Battery ( CNTB ) , and also decreased salivation and heart rate . In contrast , SDZ ENS-163 with saline had no effect on CNTB scores , increased salivation , and increased heart rate . Despite the observed cholinomimetic effects of SDZ ENS-163 when administered with saline , the changes in CNTB scores , heart rate , and salivation were indistinguishable between placebo/scopolamine and SDZ ENS-163/scopolamine . Thus , 50 mg of oral SDZ ENS-163 has cholinomimetic activity in normal men , but this dose is insufficient to reverse the muscarinic effects of 0.4 mg of intravenous scopolamine .
{ "P": [ "Scopolamine-induced cognitive impairment was used in healthy men" ], "I": [ "cholinomimetic SDZ ENS-163", "new cholinomimetic SDZ ENS-163", "oral placebo/intravenous saline", "50 mg of oral SDZ ENS-163/intravenous saline", "oral placebo/0.4 mg of intravenous scopolamine", "50 mg of oral SDZ ENS-163/0.4 mg of intravenous scopolamine" ], "O": [ "cognitive impairment", "significant cognitive impairment", "Computerized Neuropsychological Test Battery ( CNTB )", "decreased salivation and heart rate", "CNTB scores", "increased salivation", "increased heart rate", "cholinomimetic effects", "changes in CNTB scores", "heart rate", "salivation", "cholinomimetic activity", "muscarinic effects" ] }
Obesity and mortality in men with locally advanced prostate cancer : analysis of RTOG 85-31 . BACKGROUND Greater body mass index ( BMI ) is associated with shorter time to prostate-specific antigen ( PSA ) failure following radical prostatectomy and radiation therapy ( RT ) . Whether BMI is associated with prostate cancer-specific mortality ( PCSM ) was investigated in a large randomized trial of men treated with RT and androgen deprivation therapy ( ADT ) for locally advanced prostate cancer . METHODS Between 1987 and 1992 , 945 eligible men with locally advanced prostate cancer were enrolled in a phase 3 trial ( RTOG 85-31 ) and randomized to RT and immediate goserelin or RT alone followed by goserelin at recurrence . Height and weight data were available at baseline for 788 ( 83 % ) subjects . Cox regression analyses were performed to evaluate the relations between BMI and all-cause mortality , PCSM , and nonprostate cancer mortality . Covariates included age , race , treatment arm , history of prostatectomy , nodal involvement , Gleason score , clinical stage , and BMI . RESULTS The 5-year PCSM rate for men with BMI < 25 kg/m ( 2 ) was 6.5 % , compared with 13.1 % and 12.2 % in men with BMI > or =25 to < 30 and BMI > or =30 , respectively ( Gray 's P = .005 ) . In multivariate analyses , greater BMI was significantly associated with higher PCSM ( for BMI > or =25 to < 30 , hazard ratio [ HR ] 1.52 , 95 % confidence interval [ CI ] , 1.02-2.27 , P = .04 ; for BMI > or =30 , HR 1.64 , 95 % CI , 1.01-2.66 , P = .04 ) . BMI was not associated with nonprostate cancer or all-cause mortality . CONCLUSIONS Greater baseline BMI is independently associated with higher PCSM in men with locally advanced prostate cancer . Further studies are warranted to evaluate the mechanism ( s ) for increased cancer-specific mortality and to assess whether weight loss after prostate cancer diagnosis alters disease course .
{ "P": [ "locally advanced prostate cancer :", "men", "androgen deprivation therapy ( ADT ) for" ], "I": [ "radical prostatectomy", "radiation therapy", "RT and androgen deprivation therapy ( ADT )", "RT and immediate goserelin", "RT alone followed by goserelin" ], "O": [ "body mass index ( BMI )", "BMI", "all-cause mortality", "PCSM", "nonprostate cancer mortality", "5-year PCSM rate", "higher PCSM", "nonprostate cancer", "baseline BMI", "cancer-specific mortality", "weight loss" ] }
Nonnucleoside reverse transcriptase inhibitor-containing regimens are associated with increased satisfaction with sexual life .
{ "P": [], "I": [ "Nonnucleoside reverse transcriptase inhibitor-containing regimens" ], "O": [ "satisfaction with sexual life" ] }
Comparison of the time required to administer three different fluke and worm combination products to commercial beef cattle at housing . Larger livestock units , a decline in the farm labor force , animal welfare concerns , and a trend toward more selective use of drugs have increased the focus on animal handling , time management , convenience , and compliance in administering veterinary therapeutics . This study was undertaken to quantify and compare the time needed to treat commercial beef cattle with three fluke and worm combination products with different administration profiles . Young beef cattle ( n = 270 ) weighing approximately 400 kg were allocated to batches of five , which were randomly assigned to receive ivermectin + clorsulon injection , ivermectin + closantel injection , or levamisole + triclabendazole oral drench . The mean time needed to administer ivermectin + clorsulon ( single injection ) to five cattle was 31 seconds , which was significantly less than the 100 seconds needed for ivermectin + closantel ( two injections ) and the 126 seconds needed for levamisole + triclabendazole ( P < .001 ) . Such quantitative data can allow for better planning and selection of parasiticide treatment approaches at the farm level .
{ "P": [ "commercial beef cattle at housing .", "Young beef cattle", "270" ], "I": [ "fluke and worm combination products", "three fluke and worm combination products", "ivermectin + clorsulon injection", "ivermectin + closantel injection", "levamisole + triclabendazole oral drench", "ivermectin + clorsulon ( single injection )", "ivermectin + closantel", "levamisole + triclabendazole" ], "O": [ "time required", "quantify and compare the time needed to treat commercial beef cattle", "mean time needed", "planning", "selection" ] }
Uterine incision closure at caesarean section : a randomised comparative study of intraperitoneal closure and closure after temporary exteriorisation . BACKGROUND The safety of the technique of uterine exteriorization at caesarean section though popular among obstetricians , remains controversial . OBJECTIVE To evaluate the influence of exteriorization of uterus during uterine repair on caesarean morbidity . METHODS A randomized comparative study of 136 women undergoing primary caesarean delivery at Havana Specialist Hospital Lagos Nigeria . Data on operation time , estimated blood loss , postoperative morbidities were collected and analysed with comparison between the two groups using chi square , Fischer 's exact test and t-test as appropriate . RESULTS The mean operative time , estimated blood loss , transfusion rate and postoperative anemia rate were significantly less in the exteriorized group than the intraperitoneal group ( p = 0.000 , 0.009,0.048 0.038 and 0.028 respectively ) , but not in other outcome measures . CONCLUSION With shorter operative time , less blood loss and similar morbidity profile exteriorization of uterus during caesarean section seems to be preferred except where it is not possible because of adhesions and surgeons inexperience .
{ "P": [ "136", "women", "primary caesarean delivery" ], "I": [ "intraperitoneal closure and closure after temporary exteriorisation .", "technique of uterine exteriorization at caesarean section" ], "O": [ "mean operative time", "estimated blood loss", "transfusion rate", "postoperative anemia rate" ] }
Supportive-expressive group therapy for primary breast cancer patients : a randomized prospective multicenter trial . OBJECTIVE The aim is to evaluate the effectiveness of a manualized 12-week supportive-expressive group therapy program among primary breast cancer patients treated in community settings , to determine whether highly distressed patients were most likely to benefit and whether therapist 's training or experience was related to outcome . METHOD Three hundred and fifty-three women within one year of diagnosis with primary breast cancer were randomly assigned to receive supportive-expressive group therapy or to an education control condition . Participants were recruited from two academic centers and nine oncology practices , which were members of NCI 's Community Clinical Oncology Program ( CCOP ) and were followed over 2 years . RESULTS A 2x2x19 analysis of variance was conducted with main effects of treatment condition , cohort , and baseline distress and their interactions . There was no main effect for treatment condition after removing one subject with an extreme score . Highly distressed women did not derive a greater benefit from treatment . Therapist training and psychotherapy experience were not associated with a treatment effect . CONCLUSIONS This study provides no evidence of reduction in distress as the result of a brief supportive-expressive intervention for women with primary breast cancer . Future studies might productively focus on women with higher initial levels of distress .
{ "P": [ "primary breast cancer patients :", "primary breast cancer patients treated in community settings", "Highly distressed women", "primary", "women with higher initial levels of distress ." ], "I": [ "Supportive-expressive group therapy", "manualized 12-week supportive-expressive group therapy", "supportive-expressive group therapy", "education control condition", "supportive-expressive intervention" ], "O": [ "breast cancer", "effects of treatment condition", ", cohort , and baseline distress and their interactions", "treatment condition", "distressed", "greater benefit", "distress", "distress ." ] }
Covariation of adolescent physical activity and dietary behaviors over 12 months . PURPOSE This study examined covariation among changes in dietary , physical activity , and sedentary behaviors over 12 months among adolescents participating in a health behavior intervention . Evidence of covariation among behaviors would suggest multi-behavior interventions could have synergistic effects . METHODS Prospective analyses were conducted with baseline and 12-month assessments from a randomized controlled trial to promote improved diet , physical activity , and sedentary behaviors ( experimental condition ) or SUN protection behaviors ( comparison condition ) . Participants were adolescent girls and boys ( N = 878 ) aged 11-15 years on entry . The main outcomes were : diet , based on multiple 24-hour recalls ( total fat , grams of fiber , servings of fruit and vegetables , total calories ) ; average daily energy expenditure ( kcals/kg ) based on 7-day physical activity recall interviews ; daily minutes of moderate-vigorous physical activity minutes from accelerometery ; and self-reported daily hours of sedentary behavior . RESULTS Covariation was found between fat and calories ( r = .16 ) , fiber and calories ( r = .53 ) , fiber and fruit/vegetables ( r = .53 ) , calories and fruit/vegetables ( r = .34 ) , and fruit and vegetables and sedentary behavior ( r = -.12 ) for the total sample ( all p values < .01 ) . The pattern of findings was similar for most subgroups defined by gender and study condition . CONCLUSIONS The strongest covariation was observed for diet variables that are inherently related ( calories and fat , fiber , and fruit/vegetables ) . Little covariation was detected within or between other diet , physical activity and sedentary behavior domains suggesting that interventions to improve these behaviors in adolescents need to include specific program components for each target behavior of interest .
{ "P": [ "adolescent", "health behavior intervention", "girls", "boys", "878", "11-15" ], "I": [ "adolescent physical activity", "dietary behaviors", "dietary", "physical activity", "sedentary behaviors", "sedentary behaviors ( experimental condition", "SUN protection behaviors" ], "O": [ "adolescent physical activity", "dietary behaviors", "diet", "physical activity", "sedentary behaviors", "SUN protection behaviors", "average daily energy expenditure", "daily minutes of moderate-vigorous physical activity", "self-reported daily hours of sedentary behavior", "fiber and fruit/vegetables", "calories and fruit/vegetables", "fruit and vegetables", "sedentary behavior", "diet variables" ] }
The benefits of including clinical factors in rectal normal tissue complication probability modeling after radiotherapy for prostate cancer . PURPOSE To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial . METHODS AND MATERIALS Toxicity data of 512 patients ( conformally treated to 68 Gy [ n = 284 ] and 78 Gy [ n = 228 ] ) with complete follow-up at 3 years after radiotherapy were studied . Scored end points were rectal bleeding , high stool frequency , and fecal incontinence . Two traditional dose-based models ( Lyman-Kutcher-Burman ( LKB ) and Relative Seriality ( RS ) and a logistic model were fitted using a maximum likelihood approach . Furthermore , these model fits were improved by including the most significant clinical factors . The area under the receiver operating characteristic curve ( AUC ) was used to compare the discriminating ability of all fits . RESULTS Including clinical factors significantly increased the predictive power of the models for all end points . In the optimal LKB , RS , and logistic models for rectal bleeding and fecal incontinence , the first significant ( p = 0.011-0.013 ) clinical factor was " previous abdominal surgery . " As second significant ( p = 0.012-0.016 ) factor , " cardiac history " was included in all three rectal bleeding fits , whereas including " diabetes " was significant ( p = 0.039-0.048 ) in fecal incontinence modeling but only in the LKB and logistic models . High stool frequency fits only benefitted significantly ( p = 0.003-0.006 ) from the inclusion of the baseline toxicity score . For all models rectal bleeding fits had the highest AUC ( 0.77 ) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence , respectively . LKB and logistic model fits resulted in similar values for the volume parameter . The steepness parameter was somewhat higher in the logistic model , also resulting in a slightly lower D ( 50 ) . Anal wall DVHs were used for fecal incontinence , whereas anorectal wall dose best described the other two endpoints . CONCLUSIONS Comparable prediction models were obtained with LKB , RS , and logistic NTCP models . Including clinical factors improved the predictive power of all models significantly .
{ "P": [ "after radiotherapy", "prostate cancer", "512", "284", "228" ], "I": [ "complication probability modeling", "radiotherapy", "Two traditional dose-based models ( Lyman-Kutcher-Burman ( LKB ) and Relative Seriality ( RS ) and a logistic model" ], "O": [ "High stool frequency" ] }
Comments on " Comparison of gastrointestinal tolerance feeding proctocols in critically ill patients : a prospective , randomized controlled clinical trial " .
{ "P": [ "critically ill patients :", "randomized controlled clinical trial \"" ], "I": [ "tolerance feeding proctocols" ], "O": [ "gastrointestinal tolerance" ] }
A randomized controlled trial assessing the health economics of realtime teledermatology compared with conventional care : an urban versus rural perspective . A randomized controlled trial was carried out to measure the cost-effectiveness of realtime teledermatology compared with conventional outpatient dermatology care for patients from urban and rural areas . One urban and one rural health centre were linked to a regional hospital in Northern Ireland by ISDN at 128 kbit/s . Over two years , 274 patients required a hospital outpatient dermatology referral -- 126 patients ( 46 % ) were randomized to a telemedicine consultation and 148 ( 54 % ) to a conventional hospital outpatient consultation . Of those seen by telemedicine , 61 % were registered with an urban practice , compared with 71 % of those seen conventionally . The clinical outcomes of the two types of consultation were similar -- almost half the patients were managed after a single consultation with the dermatologist . The observed marginal cost per patient of the initial realtime teledermatology consultation was 52.85 Pounds for those in urban areas and 59.93 Pounds per patient for those from rural areas . The observed marginal cost of the initial conventional consultation was 47.13 Pounds for urban patients and 48.77 Pounds for rural patients . The total observed costs of teledermatology were higher than the costs of conventional care in both urban and rural areas , mainly because of the fixed equipment costs . Sensitivity analysis using a real-world scenario showed that in urban areas the average costs of the telemedicine and conventional consultations were about equal , while in rural areas the average cost of the telemedicine consultation was less than that of the conventional consultation .
{ "P": [ "274", "126" ], "I": [ "realtime teledermatology", "conventional care", "conventional outpatient dermatology care", "telemedicine consultation", "conventional hospital outpatient consultation", "telemedicine", "conventionally", "realtime teledermatology consultation", "conventional consultation", "teledermatology", "conventional consultations" ], "O": [ "health economics of realtime teledermatology", "cost-effectiveness of realtime teledermatology", "clinical outcomes", "consultation", "observed marginal cost per patient", "observed marginal cost", "total observed costs", "average costs" ] }
Measuring the impact of patient counseling in the outpatient pharmacy setting : the research design of the Kaiser Permanente/USC patient consultation study . This article describes the research method used to measure the impact of three alternative models of patient counseling in the outpatient pharmacy setting . The study was conducted in pharmacies operated by the Southern California region Kaiser Permanente Medical Care Program . Both random assignment and large-scale geographic area research designs were used . The presentation of the research design includes discussions of data collection and patient sampling methods ; the measurement of patient outcomes , including measures of health care costs and utilization , patient functional status , and quality of life . Demographic data are presented for the study population , including an analysis of potential biased selection of patients electing to participate in random assignment . Data are also presented documenting potential selection bias across geographically determined treatment groups in the geographic area design arm . Finally , the article presents the analysis plan for the study and discusses study limitations .
{ "P": [ "Measuring the impact of patient counseling in the outpatient pharmacy setting : the research design of the Kaiser Permanente/USC patient consultation study ." ], "I": [ "patient counseling" ], "O": [ "patient outcomes", "measures of health care costs and utilization", "patient functional status", "quality of life" ] }
The tolerability of lactated Ringer 's solution and BSS plus for ocular irrigation with and without the Morgan therapeutic lens . OBJECTIVE To evaluate two solutions , lactated Ringer 's ( LR ) and a balanced salt solution ( BSS Plus , Alcon Laboratories , Ft. Worth , TX ) , compared with normal saline solution ( NSS ) , for ocular irrigation in healthy adult volunteers with and without the Morgan therapeutic lens ( MTL ) . METHODS This was a prospective , double-blind , randomized study of healthy volunteers who were at least 18 years of age . Exclusion criteria included the use of analgesics within four hours of the study . A complete ophthalmologic examination was performed at baseline and at the completion of the study . Following randomization and prior to any intervention , baseline discomfort scores were obtained by means of a verbally administered , horizontal , 100-mm , unnumbered analog discomfort scale . Both eyes of each volunteer were irrigated simultaneously for 15 minutes , with additional discomfort scores being recorded every 5 minutes using the same 100-mm , unnumbered analog discomfort scale . A global evaluation to assess the method of irrigation and the solutions used for irrigation was completed by both the physician blinded to the treatment groups and the volunteers . The volunteers were continuously monitored for any adverse effects resulting from the irrigation solutions or MTL . RESULTS Sixty-three volunteers were recruited into the study , with 61 entered in the final analysis . Age and gender were balanced within each group . There was no significant difference in discomfort scores between the two groups ; however , all discomfort scores decreased over time ( p = 0.008 ) . A lens-solution interaction was identified , with LR being the most tolerated when administered with the MTL . A statistically higher ocular pH difference was seen between the pre- and postirrigation readings for the control eye in volunteers irrigated with MTL ( p = 0.046 ) . Analysis of the global evaluations for each group revealed no difference in the distributions of physician and volunteer scores . No adverse event was reported in either group . CONCLUSION There does not appear to be any difference in discomfort scores between the ocular irrigation fluids when used without the MTL . Overall , the use of the MTL appears well tolerated by healthy , adult volunteers . However , there does appear to be a significant lens-solution effect on volunteers ' discomfort scores , with LR having significantly lower discomfort scores when used for ocular irrigation with the MTL . The authors conclude that the use of the MTL for ocular irrigation is well tolerated and recommend using LR as the irrigation solution for maximal patient comfort .
{ "P": [ "healthy adult volunteers with and without the Morgan therapeutic lens ( MTL ) ." ], "I": [ "lactated Ringer 's solution", "BSS plus", "lactated Ringer 's ( LR ) and a balanced salt solution", "saline solution ( NSS )", "eyes of each volunteer were irrigated simultaneously for 15 minutes" ], "O": [ "discomfort scores", "unnumbered analog discomfort scale .", "adverse effects", "tolerated", "ocular pH difference", "physician and volunteer scores .", "adverse event", "lens-solution effect" ] }
Moderate-intensity exercise training with elements of step aerobics in patients with severe chronic heart failure . OBJECTIVE To evaluate whether a specific program of moderate-intensity step aerobics training may be sufficient to improve the exercise tolerance of patients with severe chronic heart failure . PATIENTS Twenty-six patients ( 22 men , 4 women ; mean +/- SD age , 54 +/- 9yrs ) with a history of severe chronic heart failure ( left ventricular ejection fraction of 18 % +/- 8 % ) . STUDY DESIGN Prospective , randomized , controlled trial . Patients were randomized into exercise and control groups . All patients underwent a clinical examination and a ramp pattern cycle exercise test before and after the observation period . The exercise group underwent a moderate-intensity ( 50 % of peak oxygen uptake ) 12-week training program , progressing to 100 minutes per week of step aerobics and 50 minutes per week of cycling . The control group did not perform a training program . MAIN OUTCOME MEASURES Peak oxygen uptake , peak workload , percent of predicted power ability . RESULTS Significant increases in peak oxygen uptake ( 15 +/- 3.4 to 18.5 +/- 2.9mL/kg/min ; p = .001 ) , peak workload ( 77 +/- 26 to 99 +/- 31 watts ; p = .000 ) , and percent of predicted power ability ( 43 % +/- 10 % to 56 % +/- 13 % ; p = .000 ) were observed in the exercise group . No significant changes in baseline parameters occurred in the control group . There were no critical changes in heart rate or blood pressure in either group . CONCLUSION Moderate-intensity step aerobics training significantly increases peak oxygen uptake and peak workloads in patients with severe chronic heart failure .
{ "P": [ "patients with severe chronic heart failure ." ], "I": [ "Moderate-intensity exercise training", "moderate-intensity step aerobics training", "moderate-intensity ( 50 % of peak oxygen uptake ) 12-week training program", "progressing to 100 minutes per week of step aerobics and 50 minutes per week of cycling", "perform a training program" ], "O": [ "Peak oxygen uptake", "peak workload", "percent of predicted power ability", "peak oxygen uptake", "heart rate", "blood pressure", "peak workloads" ] }
Event-related potential indices of auditory selective attention in dependent amphetamine users . BACKGROUND The aim of the present study was to further investigate a previously reported attention-related impairment in dependent amphetamine users using event-related potential ( ERP ) indices of selective attention . METHODS ERPs were recorded during an auditory selective attention task ( SAT ) that involved detecting infrequent long-duration target tones presented among short-duration tones that varied in location ( left vs. right ear ) and pitch ( low vs. high ) . Amphetamine users ( n = 19 ) were divided into two groups , high dependence ( n = 10 ) and low dependence ( n = 10 ) , based on amphetamine Severity of Dependence Scale scores , and compared to an age-matched control group ( n = 9 ) . RESULTS The high-dependence group showed slowed reaction time and reduced early processing negativity and peak N1 amplitude to location-relevant nontarget stimuli . Poor performance on the SAT was highly correlated with deficits in early processing , which were also related to poor performance on the Wechsler Memory Scale Attention/Concentration index . CONCLUSIONS It is suggested that severely dependent users suffer an inability to selectively enhance the sensory processing of relevant auditory information . This may produce poor automatic preferential processing of relevant information and increase load on limited attentional resources .
{ "P": [ "dependent amphetamine", "19", "10", "9" ], "I": [ "auditory selective attention task ( SAT )" ], "O": [ "event-related potential ( ERP ) indices", "slowed reaction time", "reduced early processing negativity", "peak N1 amplitude", "Wechsler Memory Scale Attention/Concentration index" ] }
Psychophysiological outcome of behavioral and pharmacological treatments of agoraphobia .
{ "P": [ "agoraphobia ." ], "I": [ "behavioral", "pharmacological treatments" ], "O": [ "Psychophysiological" ] }
Modulation of oxidant stress in vivo in chronic cigarette smokers . BACKGROUND Free radical-induced oxidative damage is thought to be involved in the pathogenesis of diseases associated with cigarette smoking . We examined the production of 8-epi-prostaglandin ( PG ) F2 alpha , a stable product of lipid peroxidation in vivo , and its modulation by aspirin and antioxidant vitamins in chronic cigarette smokers . METHODS AND RESULTS We performed the following studies : ( 1 ) a cross-sectional comparison of smokers and control subjects , ( 2 ) an examination of the dose-response relationship , ( 3 ) an exploration of the effect of smoking cessation ( 3 weeks ) and nicotine patch supplementation , ( 4 ) the effect of aspirin consumption , and ( 5 ) the effects of 5 days ' dosing with vitamin E ( 100 and 800 U ) , vitamin C ( 2 g ) , and their combination . 8-epi-PGF2 alpha excretion ( in pmol/mmol , mean +/- SEM ) was 176.5+/-30.6 in heavy smokers , 92.7+/-4.8 ( P < .05 ) in moderate smokers , and 54.1+/-2.7 ( P < .005 ) in nonsmokers . Urinary levels fell from 145.5+/-24.9 to 114.6+/-27.1 ( week 2 , P < .05 ) and 112.6+/-24.9 ( week 3 , P < .05 ) on cessation of smoking . Aspirin treatment failed to suppress urinary levels of 8-epi-PGF2 alpha despite a significant reduction in urinary 11-dehydro-TxB2 production and suppression of 8-epi-PGF2 alpha and TxB2 in serum . Vitamin C ( pre , 194.6+/-40.9 ; post , 137.2+/-34.1 ; P < .05 ) and a combination of vitamin C and E ( pre , 171.0+/-39.8 ; post , 133.5+/-29.6 P < .05 ) suppressed urinary 8-epi-PGF2 alpha , whereas vitamin E alone had no effect . CONCLUSIONS Urinary 8-epi-PGF2 alpha may represent a noninvasive , quantitative index of oxidant stress in vivo . Elevated levels of 8-epi-PGF2 alpha in smokers may be modulated by quitting cigarettes and switching to nicotine patches or by antioxidant vitamin therapy .
{ "P": [ "chronic cigarette smokers .", "moderate smokers", "nonsmokers" ], "I": [ "Modulation of oxidant stress in vivo", "8-epi-prostaglandin ( PG ) F2 alpha , a stable product of lipid peroxidation in vivo", "aspirin", "antioxidant vitamins", "smoking cessation", "nicotine patch supplementation", "aspirin consumption", "vitamin E", "vitamin C", "Aspirin treatment", "Vitamin C", "combination of vitamin C and E", "quitting cigarettes", "switching to nicotine patches", "antioxidant vitamin therapy" ], "O": [ "8-epi-PGF2 alpha excretion", "Urinary levels fell", "urinary levels of 8-epi-PGF2 alpha", "urinary 11-dehydro-TxB2 production", "suppression of 8-epi-PGF2 alpha and TxB2 in serum .", "urinary 8-epi-PGF2 alpha", "Urinary 8-epi-PGF2 alpha", "Elevated levels of 8-epi-PGF2 alpha in smokers" ] }
Effects of supervised exercise therapy in patients receiving radiotherapy for breast cancer . PURPOSE Postoperative radiotherapy for breast cancer has a number of associated complications . This study examined whether supervised moderate-intensity exercise could mitigate the complications that occur during radiotherapy . PATIENTS AND METHODS Forty women were randomized before radiotherapy after various operations for breast cancer . Seventeen patients who were assigned to the exercise group performed supervised moderate-intensity exercise therapy for 50 min 3 times per week for 5 weeks . Twenty-three patients in the control group were asked to perform self-shoulder stretching exercise . The World Health Organization Quality of Life-BREF ( WHOQOL-BREF ) , brief fatigue inventory ( BFI ) , range of motion ( ROM ) of the shoulder , and pain score were assessed before and after radiotherapy . RESULTS There were no significant differences noted at baseline between groups . In the exercise group , there was an increase in the WHOQOL-BREF and shoulder ROM and decrease in BFI and pain score after radiotherapy . On the other hand , patients in the control group showed decrease in the WHOQOL-BREF and shoulder ROM and increase in BFI and pain score after radiotherapy . There were statistically significant differences in the changes in the WHOQOL , BFI , shoulder ROM , and pain score between the groups . CONCLUSION Patients receiving radiotherapy for breast cancer may benefit in physical and psychological aspects from supervised moderate-intensity exercise therapy .
{ "P": [ "Forty women were randomized before radiotherapy", "Twenty-three patients", "control group", "patients" ], "I": [ "supervised exercise therapy", "radiotherapy", "moderate-intensity exercise", "exercise group", "supervised moderate-intensity exercise therapy", "control group", "perform self-shoulder stretching exercise .", "control", "supervised moderate-intensity exercise therapy ." ], "O": [ "World Health Organization Quality of Life-BREF ( WHOQOL-BREF )", "brief fatigue inventory ( BFI )", "range of motion ( ROM ) of the shoulder", "pain score", "WHOQOL-BREF and shoulder ROM", "decrease in BFI and pain score", "WHOQOL-BREF", "shoulder ROM", "increase in BFI and pain score", "WHOQOL", "BFI" ] }
Detection rates of cancer , high grade PIN and atypical lesions suspicious for cancer in the European Randomized Study of Screening for Prostate Cancer . THE AIM OF THE STUDY This article presents the incidence of prostate cancer , isolated high grade prostatic intraepithelial neoplasia ( PIN ) and atypical lesions suspicious for prostate cancer ( LSPC ) during subsequent screening rounds in the centres of five of the countries participating in the European Randomized Study of Screening for Prostate Cancer ( ERSPC ) . The incidence and predictive value of high grade PIN and LSPC for prostate cancer in subsequent biopsy following these diagnoses were evaluated . PATIENTS AND METHODS Study group consisted of 56,653 screened men in the ERSPC centres of Finland , Italy , Netherlands , Sweden and Switzerland , who underwent 3-7 screening rounds at 2-4 year interval . Data for prostate cancer were obtained from the ERSPC central database . Data for high grade PIN and LSPC were gathered from each ERSPC centre . Detection rates of subsequent prostate cancer in the first re-biopsy after these diagnoses were determined . RESULTS The average cancer detection rate was 3.5 % , 3.2 % and 3.5 % for the completed rounds 1 , 2 and 3 , respectively , in all five centres . Incidence of high grade PIN increased from 1.5 % in the first round to 5.0 % in the third round , varying among centres in the first round between 0.8 % and 7.6 % . The cancer detection rate in the first re-biopsy after the diagnosis of high grade PIN was 12.9 % . Incidence of LSPC was 2.4 % , 2.7 % , 2.2 % and 2.6 % in the first , second , third and fourth round , respectively . The cancer detection rate at the first re-biopsy after the diagnosis of LSPC was in average 33.8 % . CONCLUSIONS Cancer detection rate was stable during the three screening rounds . The wide variation in frequency in particular of high grade PIN among the ERSPC centres suggests a considerable inter-observer variation . The average comparatively low detection rate of isolated high grade PIN in the first screening round may be screening-related , while its consistent increase during three screening rounds could be the consequence of a.o . previous screening and ageing of the population . The observed low risk of prostate cancer after isolated high grade PIN in this screening setting is in line with the current recommendation to abstain from early repeat biopsies after this diagnosis . The association of LSPC with high incidence of prostate cancer in re-biopsies confirms the need for early repeat biopsies and follow-up of these men . The low percentage of LSPC ( < 3 % of biopsies ) throughout all rounds is reassuring as it limits the biopsy burden in a screening setting .
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Efficacy of intravenous granisetron to control nausea and vomiting during multiple cycles of cisplatin-based chemotherapy . The safety and efficacy of granisetron ( 10 micrograms/kg and 40 micrograms/kg ) were evaluated during a second ( n = 393 ) and third ( n = 200 ) cycle of chemotherapy in this multicenter , double-blind , randomized , parallel-group study . Granisetron was administered as a single intravenous dose before the start of cisplatin chemotherapy ( > or = 60 mg/m2 ) . Total control ( no vomiting , no retching , no nausea , and no use of antiemetic rescue medication ) after the first 24 hr following chemotherapy was achieved in 40 % and 49 % of patients in Cycles 2 and 3 , respectively , for the 10 micrograms/kg group , and in 42 % and 38 % of patients in Cycles 2 and 3 , respectively , for the 40 micrograms/kg group . Both dose levels of granisetron were well tolerated . The results demonstrate comparable efficacy between the 10 micrograms/kg and 40 micrograms/kg doses of granisetron in preventing nausea and vomiting during repeat cycles of high-dose cisplatin-based chemotherapy . The results of this study show that granisetron 10 micrograms/kg is safe and well tolerated , and remains effective with repeat cycle use .
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Promoting imitation in young children with autism : a comparison of reciprocal imitation training and video modeling . The inability to imitate is a salient diagnostic marker for autism . It has been suggested that for children with autism , imitation may be a prerequisite skill that can assist in the development of various skills . Using a multiple baseline design across subjects , the purpose of this research was to determine if two interventions , reciprocal imitation training and video modeling were effective in promoting imitation acquisition in young children with autism . Six boys were matched across various features ( i.e. , age , language , autism severity ) and randomly placed in a treatment condition . Results indicated that all six participants increased their imitation skills to varying degrees in both conditions , and imitation maintained and generalized at higher than baseline levels post treatment .
{ "P": [ "young children", "autism", "autism .", "children", "Six", "boys" ], "I": [ "reciprocal imitation training", "video modeling" ], "O": [ "promoting imitation acquisition", "imitation skills" ] }
Treatment of renal failure associated with multiple myeloma . Plasmapheresis , hemodialysis , and chemotherapy . The aims of this study were to examine in a prospective , randomized trial the efficacy of plasmapheresis in preventing irreversible renal failure in patients with multiple myeloma and to study the renal biopsy tissues from such patients . Twenty-one patients with active myeloma and progressive renal failure were randomized to one of two groups : group 1 , forced diuresis and chemotherapy ( 10 patients ) , and group 2 , forced diuresis , chemotherapy , and plasmapheresis ( 11 patients ) . Plasmapheresis and chemotherapy lowered the serum myeloma protein value much more rapidly than chemotherapy alone . Of 5 patients who were oliguric and undergoing dialysis at presentation , only 3 who were treated by plasmapheresis recovered . Of 16 polyuric patients , 5 in group 1 and 7 in group 2 showed improvement in renal function . The main factor that determined irreversibility of renal failure was the severity of myeloma cast formation .
{ "P": [ "renal failure", "multiple myeloma", "Twenty-one", "myeloma", "5", "16" ], "I": [ "forced", "diuresis", "chemotherapy", "forced diuresis", "plasmapheresis" ], "O": [ "renal failure", "irreversible renal failure", "serum myeloma protein value", "renal function" ] }
Prevalence and treatment outcome of cervicitis of unknown etiology . BACKGROUND Mucopurulent cervicitis ( MPC ) is a clinical syndrome characterized by mucopurulent discharge from the cervix and other signs of inflammation . This was a phase III , multicenter study designed to evaluate the effectiveness of placebo versus empiric antibiotic treatment for clinical cure of MPC of unknown etiology at 2-month follow-up . Unfortunately , enrollment was terminated because of low accrual of women with cervicitis of unknown etiology , but important prevalence and outcome data were obtained . METHODS Five hundred seventy-seven women were screened for MPC . Women with MPC were randomized to the treatment or placebo arm of the study , and the 2 arms were evaluated based on the etiology , clinical cure rates , adverse events ( AEs ) , and rates of pelvic inflammatory disease . RESULTS One hundred thirty-one ( 23 % [ 131/577 ] ) screened women were found to have MPC . Eighty-seven were enrolled and randomized . After excluding women with sexually transmitted infections and other exclusions , 61 % ( 53/87 ) had cervicitis of unknown etiology . The overall clinical failure rate was 30 % ( 10/33 ) , and the clinical cure rate was only 24 % ( 8/33 ) . Rates were not significantly different between the arms . There were 24 gastrointestinal AEs in the treatment arm compared with 1 AE in the placebo arm . CONCLUSIONS More than half of the cases of MPC were of unknown etiology . Clinical cure rates for the placebo and treatment arms were extremely low , with most women concluding the study with a partial response . Gastrointestinal AEs were higher in the treatment arm .
{ "P": [ "cervicitis", "women", "Five hundred seventy-seven", "MPC .", "One hundred thirty-one", "Eighty-seven" ], "I": [ "placebo", "empiric antibiotic treatment" ], "O": [ "cervicitis", "MPC", "clinical cure rates", "adverse events ( AEs )", "rates of pelvic inflammatory disease", "overall clinical failure rate", "clinical cure rate", "gastrointestinal AEs", "Clinical cure rates", "Gastrointestinal AEs" ] }
The cumulative dose response effect of eicosapentaenoic and docosahexaenoic acid on blood pressure , plasma lipid profile and diet pattern in mild to moderate essential hypertensive black patients . In this study eicosapentaenoic acid ( EPA ) and docosahexaenoic acid ( DHA ) were given in a cumulative manner , every 6 weeks , starting with 10 mg , then 100 mg , 1000 mg and 10,000 mg EPA daily to mild to moderate essential hypertensive black patients . The corresponding DHA doses were 3 , 33 , 333 and 3333 mg. A control group was given olive oil as placebo for the entire 24 weeks . The placebo group had lower diastolic and systolic blood pressures after 24 weeks than the EPA and DHA group . No effect was seen on plasma triglycerides , cholesterol , HDL-cholesterol and gamma-glutamyltranspeptidase at any stage of the trial . In the EPA group plasma free-EPA increased significantly from 1000 mg onwards and plasma free-arachidonic acid ( AA ) decreased after 1000 mg EPA . No other plasma free essential fatty acid changed during the trial , although the HDL : cholesterol increased slightly but non-significantly with an increase in EPA and DHA . No significant changes in diet pattern or body mass was observed . It is therefore concluded that EPA and DHA supplementation had no beneficial effects in mild to moderate essential hypertensive black patients except for a lowering of plasma AA .
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Home blood pressure monitoring : advantages and limitations . Home blood pressure monitoring is a useful tool for clinical management of patients with hypertension . Its major advantages are the ease with which the techniques can be learned , reproducibility of values , sensitivity of measurement and availability of normotensive data . In spite of the ability to tell whether a subject has normal or abnormal values , because of the lack of prospective mortality/morbidity data , home blood pressure monitoring can not be used to decide whether treatment is indicated . The treatment decision must be based on repeated clinic blood pressure readings . After that the home blood pressure monitoring can be used to exclude individuals who are at risk for side effects due to low out-of-office blood pressure readings and to precisely monitor the blood pressure response to therapy . Home blood pressure monitoring is frequently used to find subjects with 'white-coat ' hypertension . In our study of borderline hypertension in Tecumseh , white-coat hypertension is present in 7.1 % of the whole population and in 58 % of all subjects with elevated blood pressures in the clinic . Subjects with white-coat hypertension in Tecumseh appear to be at an increased risk for coronary heart disease : they show repeated elevated clinic readings throughout their life time , their parents have higher blood pressure , their high-density lipoprotein is decreased and insulin , cholesterol and triglycerides are elevated . Whereas subjects with white-coat hypertension should not be treated with antihypertensive agents , they must be followed and managed through non-pharmacologic means .
{ "P": [ "hypertension", "borderline hypertension" ], "I": [ "Home blood pressure monitoring", "home blood pressure monitoring", "clinic blood pressure", "non-pharmacologic means" ], "O": [ "blood pressure", "clinical management", "clinic blood pressure readings", "blood pressure response", "'white-coat ' hypertension .", "blood pressures", "coronary heart disease", "clinic readings", "high-density lipoprotein", "insulin", "cholesterol", "triglycerides" ] }
Are PRO discharge screens associated with postdischarge adverse outcomes ? OBJECTIVE We evaluate whether patient outcomes may be affected by possible errors in care at discharge as assessed by Peer Review Organizations ( PROs ) . DATA SOURCES/STUDY SETTING The three data sources for the study were ( 1 ) the generic screen results of a 3 percent random sample of Medicare beneficiaries age 65 years or older who were admitted to California hospitals between 1 July 1987 and 30 June 1988 ( n = 20,136 patients ) ; ( 2 ) the 1987 and 1988 California Medicare Provided Analysis and Review ( MEDPAR ) data files ; and ( 3 ) the American Hospital Association ( AHA ) 1988 Annual Survey of Hospitals . STUDY DESIGN Multivariate logistic regression analysis was used to evaluate the association between the results of generic discharge administered by the PROs and two patient outcomes : mortality and readmission within 30 days . The analysis was adjusted for other patient characteristics recorded on the uniform discharge abstract . PRINCIPAL FINDINGS Four discharge screens indicated an increased risk of an adverse outcome-absence of documentation of discharge planning , elevated temperature , abnormal pulse , and unaddressed abnormal test results at discharge . The other three discharge screens examined-abnormal blood pressure , IV fluids or drugs , and wound drainage before discharge-were unrelated to postdischarge adverse outcomes . CONCLUSIONS Generic discharge screens based on inadequate discharge planning , abnormal pulse , increased temperature , or unaddressed abnormal tests may be important indicators of substandard care . Other discharge screens apparently do not detect errors in care associated with major consequences for patients .
{ "P": [ "The three data sources for the study were ( 1 ) the generic screen results of a 3 percent random sample of Medicare beneficiaries age 65 years or older who were admitted to California hospitals between 1 July 1987 and 30 June 1988 ( n = 20,136 patients ) ; ( 2 ) the 1987 and 1988 California Medicare Provided Analysis and Review ( MEDPAR ) data files ; and ( 3 ) the American Hospital Association ( AHA ) 1988 Annual Survey of Hospitals ." ], "I": [ "PRO discharge screens", "generic screen results", "Analysis and Review ( MEDPAR ) data files ;", "Multivariate logistic regression analysis", "Generic discharge screens" ], "O": [ "risk of an adverse outcome-absence of documentation of discharge planning", "elevated temperature", "abnormal pulse", "unaddressed abnormal test results", "examined-abnormal blood pressure", "IV fluids or drugs", "wound drainage", "increased temperature", "unaddressed abnormal tests" ] }
Effect of laquinimod on MRI-monitored disease activity in patients with relapsing-remitting multiple sclerosis : a multicentre , randomised , double-blind , placebo-controlled phase IIb study . BACKGROUND A 24-week phase II trial has shown that 0.3 mg of laquinimod given daily to patients with relapsing-remitting multiple sclerosis was well tolerated and reduced the formation of active lesions . We assessed the effect of oral daily 0.3 and 0.6 mg laquinimod on MRI-monitored disease activity in a 36-week double-blind , placebo-controlled phase IIb study . METHODS The study was done in 51 centres in nine countries . Inclusion criteria were one or more relapses in the year before entry and at least one gadolinium enhancing ( GdE ) lesion on screening MRI . Of 720 patients screened , 306 eligible patients were enrolled . Patients , aged 18-50 years , were randomly assigned to placebo ( n=102 ) , laquinimod 0.3 mg a day ( n=98 ) , or 0.6 mg a day ( n=106 ) . Brain MRI scans and clinical assessments were done at week -4 , baseline , and monthly from week 12 to week 36 . The primary outcome was the cumulative number of GdE lesions at weeks 24 , 28 , 32 , and 36 . The principal analysis of the primary endpoint was done on the intention-to-treat cohort . This study is registered with ClinicalTrials.gov , number NCT00349193 . FINDINGS Compared with placebo , treatment with laquinimod 0.6 mg per day showed a 40.4 % reduction of the baseline adjusted mean cumulative number of GdE lesions per scan on the last four scans ( simple means 4.2 [ SD 9.2 ] vs 2.6 [ 5.3 ] , p=0.0048 ) ; treatment with 0.3 mg per day showed no significant effects ( 3.9 [ 5.5 ] vs placebo , p=0.6740 ) . Both doses of laquinimod were well tolerated , with some transient and dose-dependent increases in liver enzymes . A case of Budd-Chiari syndrome-ie , a thrombotic venous outflow obstruction of the liver-occurred after 1 month of exposure in a patient with underlying hypercoagulability who received 0.6 mg laquinimod . Anticoagulant treatment resulted in a decline of liver enzymes to normal without any clinical signs of hepatic decompensation . INTERPRETATION In patients with relapsing-remitting multiple sclerosis , 0.6 mg per day laquinimod significantly reduced MRI-measured disease activity and was well tolerated .
{ "P": [ "relapsing-remitting multiple sclerosis", "multicentre", "51 centres in nine countries .", "one or more relapses in the year before entry and at least one gadolinium enhancing ( GdE ) lesion on screening MRI .", "306", "18-50" ], "I": [ "laquinimod", "placebo" ], "O": [ "MRI-monitored disease activity", "active lesions", "MRI-monitored disease", "gadolinium enhancing ( GdE ) lesion", "Brain MRI scans and clinical assessments", "cumulative number of GdE lesions", "cumulative number of GdE lesions per scan", "liver enzymes", "Budd-Chiari syndrome-ie", "thrombotic venous outflow obstruction of the liver-occurred", "hepatic decompensation", "MRI-measured disease activity" ] }
Reducing Sitting Time After Stroke : A Phase II Safety and Feasibility Randomized Controlled Trial . OBJECTIVE To test the safety , feasibility , and effectiveness of reducing sitting time in stroke survivors . DESIGN Randomized controlled trial with attention-matched controls and blinded assessments . SETTING Community . PARTICIPANTS Stroke survivors ( N=35 ; 22 men ; mean age , 66.9±12.7y ) . INTERVENTIONS Four counseling sessions over 7 weeks with a message of sit less and move more ( intervention group ) or calcium for bone health ( attention-matched control group ) . MAIN OUTCOME MEASURES Measures included safety ( adverse events , increases in pain , spasticity , or fatigue ) and feasibility ( adherence to trial protocol ) . Secondary measures included time spent sitting ( including in prolonged bouts ≥30min ) , standing , and stepping as measured by the thigh-worn inclinometer ( 7d , 24h/d protocol ) and time spent in physical activity of at least moderate intensity as measured by a triaxial accelerometer . The Multimedia Activity Recall for Children and Adults was used to describe changes in use of time . RESULTS Thirty-three participants completed the full protocol . Four participants reported falls during the intervention period with no other adverse events . From a baseline average of 640.7±99.6min/d , daily sitting time reduced on average by 30±50.6min/d ( 95 % confidence interval [ CI ] , 5.8-54.6 ) in the intervention group and 40.4±92.5min/d in the control group ( 95 % CI , 13.0-93.8 ) . Participants in both groups also reduced their time spent in prolonged sitting bouts ( ≥30min ) and increased time spent standing and stepping . CONCLUSIONS Our protocol was both safe and feasible . Participants in both groups spent less time sitting and more time standing and stepping postintervention , but outcomes were not superior for intervention participants . Attention matching is desirable in clinical trials and may have contributed to the positive outcomes for control participants .
{ "P": [], "I": [ "reducing sitting time in stroke survivors" ], "O": [ "adverse events", "pain", "spasticity , or fatigue )", "feasibility ( adherence to trial protocol", "spent sitting ( including in prolonged bouts ≥30min )", "standing", "and", "time spent in physical activity", "The Multimedia Activity Recall for Children and Adults", "reported falls", "other adverse events", "sitting time", "time spent in prolonged sitting", "spent standing and stepping" ] }
Milk production in cows with endotoxin-induced mastitis treated with isotonic or hypertonic sodium chloride solution . Milk production was monitored in 16 cows for 6 milkings after intramammary infusion of 1 mg of endotoxin in a single forequarter . The cows were randomly assigned to 1 of 2 treatment groups ; 8 cows were treated with isotonic saline solution and 8 cows were treated with hypertonic saline solution . Saline solutions were administered IV ( 5 ml/kg of body weight ) 4 hours after infusion of endotoxin . Mean cumulative change in milk yield and interval change in milk yield were greater in cows treated with isotonic saline solution than in cows treated with hypertonic saline solution . Significant differences between treatment groups were not detected .
{ "P": [ "endotoxin-induced mastitis", "16", "8", "cows" ], "I": [ "endotoxin-induced mastitis", "isotonic or hypertonic sodium chloride solution", "endotoxin", "isotonic saline solution", "hypertonic saline solution", "Saline", "solution" ], "O": [ "Milk production", "Mean cumulative change in milk yield and interval change in milk yield" ] }
Comparison of the cardiorespiratory effects of a combination of ketamine and propofol , propofol alone , or a combination of ketamine and diazepam before and after induction of anesthesia in dogs sedated with acepromazine and oxymorphone . OBJECTIVE To evaluate the cardiorespiratory effects of IV administration of propofol ( 4 mg/kg ) , ketamine hydrochloride and propofol ( 2 mg/kg each ; K-P ) , or ketamine hydrochloride ( 5 mg/kg ) and diazepam ( 0.2 mg/kg ; K-D ) before and after induction of anesthesia ( IoA ) in dogs sedated with acepromazine maleate and oxymorphone hydrochloride . ANIMALS 10 healthy adult Beagles . PROCEDURES Each dog was randomly allocated to receive 2 of 3 treatments ( 1-week interval ) . For instrumentation prior to each treatment , each dog was anesthetized with isoflurane . After full recovery , acepromazine ( 0.02 mg/kg ) and oxymorphone ( 0.05 mg/kg ) were administered IV . Fifteen minutes later ( before IoA ) , each dog received treatment IV with propofol , K-P , or K-D. Cardiorespiratory and arterial blood gas variables were assessed before , immediately after , and 5 minutes after IoA . RESULTS Compared with findings before IoA , dogs receiving the K-P or K-D treatment had increased cardiac output , oxygen delivery , and heart rate 5 minutes after IoA ; K-P administration did not change mean arterial blood pressure or stroke volume and decreased systemic vascular resistance . Propofol decreased mean arterial blood pressure and systemic vascular resistance immediately after IoA but did not change heart rate , cardiac output , or oxygen delivery . All treatments caused some degree of apnea , hypoventilation , and hypoxemia ( Pao2 < 80 mm Hg ) . CONCLUSIONS AND CLINICAL RELEVANCE In dogs , K-P treatment maintained mean arterial blood pressure better than propofol alone and increased heart rate , cardiac output , or oxygen delivery , as did the K-D treatment . Supplemental 100 % oxygen should be provided during IoA with all 3 treatments .
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Do sheltered workshops enhance employment outcomes for adults with autism spectrum disorder ? This study investigated whether sheltered workshops help prepare individuals with autism spectrum disorder ( ASD ) for competitive employment within the community . Two groups of individuals were compared : ( a ) 215 supported employees who were in sheltered workshops prior to entering supported employment and ( b ) 215 supported employees who were not in sheltered workshops . Individuals from both groups were matched based on their primary diagnosis , secondary diagnosis ( if present ) , and gender . Results showed that there were no differences in rates of employment between these two groups . However , individuals who participated in sheltered workshops earned significantly less ( US $ 129.36 versus US $ 191.42 per week ) , and cost significantly more to serve ( US $ 6,065.08 versus US $ 2,440.60 ) , than their non-sheltered workshop peers . Results presented here suggest that individuals with ASD achieve better vocational outcomes if they do not participate in sheltered workshops prior to enrolling in supported employment .
{ "P": [ "adults with autism spectrum disorder", "( a ) 215 supported employees who were in sheltered workshops prior to entering supported employment and ( b ) 215 supported employees who were not in sheltered workshops ." ], "I": [ "sheltered workshops", "not in sheltered workshops", "non-sheltered workshop" ], "O": [ "employment outcomes", "competitive employment", "rates of employment", "earned significantly less", "cost significantly more", "better vocational outcomes" ] }
Physical activity for patients undergoing an allogeneic hematopoietic stem cell transplantation : benefits of a moderate exercise intervention . UNLABELLED An allogeneic hematopoietic stem cell transplantation ( HSCT ) can have profound and lasting adverse effects on a patient 's physical and psychological well-being . So far , only few studies have investigated the effectiveness of physical activity over the entire inpatient phase of an allogeneic HSCT . PURPOSE We performed a randomized controlled study to examine the influence of a controlled moderate exercise program starting parallel to chemotherapeutic conditioning and total body irradiation on the patient 's physical and psychological constitution . PATIENTS AND METHODS Forty-seven patients undergoing an allogeneic HSCT were randomly assigned to an exercise group ( EG ) or a control group ( CG ) . While the EG took part in an endurance and activity of daily living-training twice a day , the CG received the clinic 's standard physiotherapy program once a day . RESULTS Significant differences and/or trends in favor of the EG were observed regarding the primary endpoint endurance performance ( P=0.002 ) , muscular strength ( P=0.022 ) , fatigue ( P=0.046 ) , and emotional state ( P=0.028 ) without posing an additional risk for the individual . CONCLUSION The results show that the training program is feasible and seems to have positive influences on physical performance and quality of life in patients undergoing an allogeneic HSCT . However , further studies are necessary to confirm these results .
{ "P": [ "allogeneic hematopoietic stem cell transplantation", "Forty-seven", "allogeneic HSCT", "patients undergoing an allogeneic HSCT" ], "I": [ "moderate exercise intervention", "allogeneic hematopoietic stem cell transplantation", "moderate exercise program", "exercise group ( EG )", "control group ( CG )" ], "O": [ "effectiveness", "endurance performance", "muscular strength", "fatigue", "emotional state", "physical performance and quality of life" ] }
Effects of resistance versus endurance training on serum adiponectin and insulin resistance index . PURPOSE The purpose of the present study was to investigate the effects of resistance and endurance training on serum adiponectin and insulin resistance index ( SI ) in healthy men . METHODS Twenty-four healthy males ( age , 35-48 years ) participated in the study . The subjects were randomly assigned to one of three groups : endurance training group ( n=8 ) , resistance training group ( n=8 ) and control group ( n=8 ) . Blood samples were taken in fasting state from all subjects . The experimental groups performed either endurance or resistance training 3 days a week for 12 weeks . The endurance training programme included continuous running at an intensity corresponding to 75-85 % of maximal heart rate , while resistance training consisted of four sets of circuit weight training for 11 stations and at an intensity corresponding to 50-60 % of one-repetition maximum . The maximum numbers of repetitions in each station was 12 . RESULTS There were significant negative correlations between serum adiponectin and body fat percentage , waist-to-hip ratio , body mass index and the insulin resistance index at baseline , whereas changes in response to training were not significantly correlated . Both endurance and resistance training resulted in a significant decrease in the SI in comparison with the control group . However , serum adiponectin did not change significantly in response to resistance and endurance training . CONCLUSION Endurance and resistance training caused an improvement in insulin resistance in healthy men , but this improvement was not accompanied by increased adiponectin levels .
{ "P": [ "healthy", "men", "Twenty-four", "males", "age , 35-48 years" ], "I": [ "resistance versus endurance training", "resistance and endurance training", "endurance training", "group ( n=8 ) ,", "resistance training", "group ( n=8 ) and", "control", "group ( n=8 )", "endurance", "endurance training programme" ], "O": [ "serum adiponectin and insulin resistance index .", "serum adiponectin and insulin resistance index ( SI )", "Blood samples", "serum adiponectin and body fat percentage , waist-to-hip ratio , body mass index and the insulin resistance index at baseline", "SI", "serum adiponectin" ] }
Nimodipine pharmacotherapeutic adjuvant therapy for inpatient treatment of cocaine dependence . Recent preclinical studies suggest utility for voltage-sensitive calcium channel blockers ( VSCCBs ) in the treatment of cocaine addiction . The following double-blind placebo-controlled study examined the role of the VSCCB nimodipine in attenuating cocaine craving in 66 recently abstinent cocaine-dependent patients on an inpatient substance abuse treatment unit utilizing an intensive 12-step milieu-oriented psychosocial therapy . While the medication was well tolerated , the dose of nimodipine used in this study ( 90 mg q.d . ) was not superior to placebo in reducing background or cue-induced cocaine craving over the 3 weeks of the study . There was the suggestion that nimodipine might attenuate the severity of some cocaine-induced brain deficits , as detected by evaluation of smooth pursuit eye movement function . A rationale for evaluating higher doses of nimodipine for the treatment of cocaine addiction is presented . As nimodipine might have anticraving and mood-stabilizing properties and cardio- and neuroprotective properties in the face of cocaine intoxication and might possibly even reverse some cocaine-induced brain deficits , further investigation of the role of nimodipine ( and other VSCCBs ) in cocaine addiction appears an attractive avenue of future medication development .
{ "P": [ "inpatient treatment of cocaine dependence .", "cocaine addiction ." ], "I": [ "Nimodipine", "placebo-controlled", "nimodipine", "placebo" ], "O": [ "smooth pursuit eye movement function ." ] }
Antihypertensive and volume-depleting effects of mild exercise on essential hypertension . After a general clinical observation period of over 4 weeks , 20 essential hypertensive subjects ( Japanese ) were randomly divided into two groups . One group ( n = 10 ; 4 men and 6 women ; 51.4 +/- 2.8 years of age ) agreed to physical training using bicycle ergometer exercise with the intensity at blood lactate threshold for 60 minutes three times a week for 10 weeks , while the other group ( n = 10 ; 4 men and 6 women ; 51.0 +/- 2.9 years of age ) did no particular physical training and was followed once a week as the control . Changes in blood pressure , hemodynamics , and humoral factors of the exercised group were compared with values in the controls . The following significant changes were found only in the exercised group . Blood pressure was significantly ( p less than 0.01 ) reduced . Whole blood and plasma volume indices were significantly reduced ( p less than 0.05 , p less than 0.01 , respectively ) . The change in ratio of serum sodium to potassium positively correlated with the change in systolic blood pressure ( r = 0.76 , p less than 0.02 ) . Plasma norepinephrine concentrations both at rest and at the workload of blood lactate threshold during graded exercise tests were significantly reduced ( p less than 0.05 , p less than 0.02 respectively ) after 10 weeks of exercise training . The change in the resting level of plasma norepinephrine positively correlated with that in the mean blood pressure . No such changes were observed in the control group . In both groups , body weight and urinary sodium excretion showed no statistically significant changes . ( ABSTRACT TRUNCATED AT 250 WORDS )
{ "P": [], "I": [ "mild exercise", "physical training using bicycle ergometer exercise with the intensity at blood lactate threshold for 60 minutes three times a week for 10 weeks", "no particular physical training", "exercise training ." ], "O": [ "blood pressure", "hemodynamics", "humoral factors", "Blood pressure", "Whole blood and plasma volume indices", "systolic blood pressure", "Plasma norepinephrine concentrations", "resting level of plasma norepinephrine", "mean blood pressure ." ] }
Incidence of candida in hospital in-patients and the effects of antibiotic therapy .
{ "P": [], "I": [ "antibiotic therapy" ], "O": [ "Incidence of candida" ] }
Long-term efficacy of subcutaneous sumatriptan using a novel self-injector . An open , multicenter study investigated the long-term efficacy , tolerability , and acceptability to patients of subcutaneous sumatriptan 6 mg , administered using a novel cartridge system self-injector , for the acute treatment of migraine . Eighty patients treated all migraine attacks for 6 months at home with a subcutaneous injection of sumatriptan 6 mg. A second injection could be taken after 1 to 24 hours if relief was inadequate , or if the headache recurred , and rescue medication could be taken 1 hour after the second injection . The primary end point was the percentage of attacks in which headache improved from severe or moderate before treatment to mild or absent at 1 hour after the first injection . A total of 1566 attacks were treated by the 80 patients and 69 patients completed 6 months of treatment . Headache relief was reported 1 hour after the first injection in a mean of 78 % of attacks ( 83 % in the first 3 months and 76 % in the second 3 months ) . A second injection was required in a mean of 40 % of attacks , and headache was mild or absent 1 hour after the second injection in a mean of 77 % of attacks . Rescue medication was required after the second injection in a mean of 14 % of attacks . At the end of the study , 87 % of patients said that they would take the medication again , and at each clinic visit over 80 % said that they found the injector easy to use . Adverse events were similar to those reported previously with sumatriptan and were mostly mild to moderate in intensity , short-lived , and resolved spontaneously . Subcutaneous sumatriptan 6 mg is an effective , well tolerated , and well accepted , long-term , acute treatment for migraine when self-injected by patients using the novel self-injector .
{ "P": [ "migraine", "Eighty", "sumatriptan", "80", "69" ], "I": [ "subcutaneous sumatriptan", "sumatriptan", "injection of sumatriptan 6 mg." ], "O": [ "headache", "Headache relief", "Rescue medication" ] }
Early versus late hCG administration to trigger ovulation in mild stimulated IUI cycles : a randomized clinical trial . OBJECTIVES To verify non-inferiority of the clinical pregnancy rate of Early hCG administration ( leading follicle sizes within 16.0-16.9 mm in diameter ) compared to Late hCG administration ( leading follicle sizes within 18.0-18.9 mm in diameter ) . STUDY DESIGN Prospective randomized trial . Six hundred and twelve infertile women candidates for intrauterine insemination ( IUI ) received HP-hMG 75 IU/day SC from cycle days 4 to 8 and then as per ovarian response . Ovulation was randomly triggered ( hCG 5000 IU , IM ) when the leading follicle diameter ranged between either 16.0 and 16.9 mm ( Early hCG group , n=227 ) or 18.0 and 18.9 mm ( Late hCG group , n=207 ) and IUI was performed approximately 36 h later . RESULTS Whereas population and sperm characteristics were comparable in both groups , the number of follicles ≥ 14 mm in diameter ( P < 0.007 ) and serum estradiol levels ( P < 0.001 ) on the day of hCG were lower in the Early versus the Late hCG groups . Clinical ( 11.9 % versus 12.1 % ) and ongoing ( 11.0 % versus 8.6 % ) pregnancy rates per randomized women were similar in the two groups and statistical non-inferiority of clinical and ongoing pregnancy rates was demonstrated . CONCLUSION These results suggest that hCG administered when the largest follicle size reaches 16.0-16.9 mm leads to similar clinical and ongoing pregnancy rates as when it reaches 18.0-18.9 mm in IUI cycles .
{ "P": [], "I": [ "hCG administration", "Early hCG administration", "Late hCG administration", "HP-hMG", "hCG" ], "O": [ "population and sperm characteristics", "number of follicles", "serum estradiol levels", "pregnancy rates" ] }
Safety , pharmacokinetics and pharmacodynamics of GS-9620 , an oral Toll-like receptor 7 agonist . BACKGROUND GS-9620 is a novel oral agonist of Toll-like receptor 7 ( TLR7 ) in development for the treatment of chronic viral hepatitis . TLR7 is a highly conserved innate immune receptor expressed primarily on plasmacytoid dendritic cells and B lymphocytes . The aim of this double-blind , placebo-controlled , single ascending-dose study was to investigate the safety , tolerability , pharmacokinetics and pharmacodynamics of GS-9620 in healthy volunteers . METHODS In total , 75 healthy volunteers ( 8 subjects in each of the 10 cohorts ; 5 subjects participated in two cohorts ) were randomized ( 6:2 ) to receive a single dose of GS-9620 ( 0.3 , 1 , 2 , 4 , 6 , 8 or 12 mg ) or placebo . RESULTS GS-9620 was well-absorbed and well-tolerated in oral doses up to 12 mg . Minimal treatment-related adverse events were seen at doses up to 8 mg. Serum interferon ( IFN ) -α was only detected in subjects who received 8 or 12 mg doses , and the adverse event profile at 8 and 12 mg doses was generally consistent with that associated with IFN-α exposure ( flu-like symptoms ) , consistent with the mechanism of TLR7 agonism . All adverse events resolved within 72 h. Induction of chemokines/cytokines and IFN-stimulated genes were seen at GS-9620 doses ≥ 2 mg , well below doses that induced serum IFN-α or led to clinical adverse events . CONCLUSIONS GS-9620 demonstrates safety and pharmacodynamic activity at doses up to 12 mg. Pharmacodynamic activity is seen before adverse events , suggesting the potential for induction of an antiviral response without systemic adverse events in subjects with chronic viral hepatitis .
{ "P": [ "healthy volunteers ." ], "I": [ "GS-9620", "placebo-controlled", "single dose of GS-9620 ( 0.3 , 1 , 2 , 4 , 6 , 8 or 12 mg )" ], "O": [ "safety", "tolerability", "pharmacokinetics", "pharmacodynamics", "well-absorbed", "well-tolerated", "Minimal treatment-related adverse events" ] }
In vitro determination of the chromatic effect of a silver nanoparticles solution linked to the gantrez S-97 copolymer on tooth enamel . Silver nanoparticles ( NNPs ) , alone or in combination with the bioadhesive Gantrez S-97 , have demonstrated their efficacy against Streptococcus mutans ; however , it is not known if this combination changes the color of teeth . The aim of this work was to measure the color changes occurring after the use of a Gantrez-NNP combination on enamel tooth blocks . Two study groups were randomly formed : enamel blocks brushed with ( a ) the Gantrez-NNP combination and ( b ) conventional toothpaste , for 1 minute once daily for 4 weeks , then rinsed with distilled water and placed in thymol solution . Color changes in the enamel blocks were measured using a Minolta colorimeter CR300 . Analysis of mixed models was performed with R 2.10.1 at a 95 % confidence level , using the nonlinear mixed effects ( NLME ) package . The results showed that there were no color changes over time , only a high luminosity equal in both groups . Our study showed that the use of the Gantrez-NNP combination is safe with respect to dental esthetics in the control of S. mutans .
{ "P": [ "tooth enamel .", "enamel blocks", "dental esthetics" ], "I": [ "silver nanoparticles solution", "gantrez S-97 copolymer", "Silver nanoparticles ( NNPs )", "Gantrez S-97", "Gantrez-NNP combination", "the Gantrez-NNP combination", "conventional toothpaste", "rinsed with distilled water and placed in thymol solution" ], "O": [ "chromatic effect", "color of teeth", "color changes", "Color changes in the enamel blocks", "Minolta colorimeter CR300", "no color changes over time", "high luminosity equal", "safe" ] }
Characterization of early thermal burns and the effects of hyperbaric oxygen treatment : a pilot study . BACKGROUND AND AIMS Studies investigating hyperbaric oxygen treatment ( HBOT ) to improve outcome in burns have been inconclusive . In this study , we aimed to characterize early thermal burns injury in adult patients with < 40 % total body surface area ( TBSA ) and to determine the effects of HBOT administered within 24 h to 48 h of a burn injury . METHODS Seventeen subjects were randomized into control ( n = 9 ) and HBOT treatment ( n = 8 ) arms . Burn depth , measured by laser Doppler imaging ( LDI ) and histologically , white blood cell ( WBC ) count and plasma cytokine inflammatory markers were assessed at 24 h ( pre HBOT ) and 48 h ( post HBOT ) post burn , as were immunohistochemistry and microbiology of burns tissue samples at 48 h post burn . RESULTS WBC count and serum interleukin ( IL ) -1β , IL-4 , IL-6 , IL-10 and interferon-γ were significantly elevated 24 h after burn , but no significant changes in any of these parameters were found with HBOT . HBOT had no significant effect on burn depth . Two HBOT patients and four control patients developed positive bacterial cultures . CONCLUSIONS Slower than anticipated recruitment resulted in considerably fewer patients than planned being studied . Inflammatory markers were significantly increased at 24 h in patients with < 40 % TBSA burn . Early HBOT had no apparent effects on any of the parameters measured in this small pilot study . HBOT may possibly have a broad-spectrum antimicrobial effect worthy of further study . We report our methodology in detail as a possible model for future burns studies .
{ "P": [ "burns", "early thermal burns injury", "adult", "< 40 % total body surface area ( TBSA", "Seventeen", "9", "8" ], "I": [ "hyperbaric oxygen treatment", "hyperbaric oxygen treatment ( HBOT )", "HBOT", "HBOT treatment", "Doppler imaging" ], "O": [ "Burn depth", "white blood cell ( WBC ) count", "plasma cytokine inflammatory markers" ] }
S-phase kinase-associated protein 2 expression in laryngeal squamous cell carcinomas and its prognostic implications . The F-box protein S-phase kinase-associated protein 2 ( Skp2 ) positively regulates the G1-S transition by controlling the stability of several G1 regulators , such as the cell cycle inhibitor p27kip1 . However , the clinical significance of Skp2 in patients with laryngeal squamous cell carcinoma ( LSCC ) remains unknown . In this study , a potential distribution of Skp2 in LSCC and its clinical implications was investigated by an immunohistochemical study . Overall , Skp2 overexpression was observed in 36.7 % ( 37 of 102 ) patients and was significantly associated with lymph node metastasis ( p=0.002 ) and was inversely associated with p27kip1 expression ( p=0.026 ) . Survival analysis using the Kaplan-Meier method showed that Skp2 overexpression was significantly associated with shorter disease-free and overall survival ( p=0.0051 and p=0.0002 , respectively ) . When Skp2 expression and p27kip1 expression were combined , patients with both Skp2 overexpression and reduced expression of p27kip1 revealed poorest disease-free and overall survival as compared to the other cases ( p=0.0017 and p < 0.0001 , respectively ) . Additionally , in early stage ( I , II ) cases , Skp2 expression was also revealed to possess a significant prognostic factor in overall survival ( p=0.0234 ) , but not in disease-free survival ( p=0.2055 ) . By multivariate analysis using the Cox proportional hazards model , tumor grade , tumor size , clinical stage and Skp2 expression were independent prognostic factors both in disease-free and overall survival . These findings indicated that Skp2 expression was closely associated with tumor progression and represented an independent marker for prognosis of LSCC .
{ "P": [ "laryngeal squamous cell carcinomas", "LSCC", "37", "102" ], "I": [ "S-phase kinase-associated protein", "Skp2", "immunohistochemical study", "." ], "O": [ "Skp2 overexpression", "Survival analysis", "disease-free and overall survival", "Skp2 expression", "p27kip1 expression", "expression of p27kip1", "poorest disease-free", "overall survival", "overall survival ( p=0.0234 )", "disease-free survival", "proportional hazards model , tumor grade , tumor size , clinical stage and Skp2 expression", "disease-free and overall survival ." ] }
Effects of halothane and isoflurane on transient renal dysfunction associated with infrarenal aortic cross-clamping . Aortic cross-clamping for reconstructive aortic surgery is associated with impairment of renal function . Halothane or isoflurane was used to assess the influence of volatile anesthesia on renal hemodynamics during aortic surgery . Nineteen patients with normal preoperative creatinine clearances who were scheduled for reconstructive aortic surgery were randomly divided into two groups : halothane group ( n = 9 ) and isoflurane group ( n = 10 ) . Induction of anesthesia consisted of midazolam , fentanyl , and pancuronium . Anesthesia was maintained with fentanyl and halothane or isoflurane in nitrous oxide and oxygen ( 50/50 ) . Systemic hemodynamics were similar in both groups throughout surgery . Before aortic cross-clamping , effective renal plasma flow ( ERPF ) ( 131I-hippuran clearance ) and glomerular filtration rate ( GFR ) ( 99Tc-DTPA clearance ) were significantly lower in the halothane group ( 118.4 +/- 25.6 and 19.7 +/- 5.2 mL/min , respectively ) than in the isoflurane group ( 253.4 +/- 51.5 and 44.9 +/- 8.4 mL/min ) ( P less than 0.05 for both ) . During cross-clamping , the renal variables were not markedly affected in either group and remained higher in the isoflurane-anesthetized patients ( 232.9 +/- 47.1 and 49.5 +/- 1.2 mL/min for ERPF and GFR , respectively ) than in the halothane-anesthetized patients ( 132.4 +/- 31.6 and 14.8 +/- 3.7 mL/min , respectively ) ( P less than 0.05 ) . After aortic unclamping , ERPF increased markedly in both groups ( 467.8 +/- 122 and 362.5 +/- 57.7 mL/min in the halothane and isoflurane groups , respectively ) , as did GFR ( 74.8 +/- 22 and 71.8 +/- 13.1 mL/min , respectively ) . These results suggest that anesthesia with halothane is associated with transient renal vasoconstriction during abdominal surgery . In contrast , aortic cross-clamping during isoflurane anesthesia was not associated with renal hemodynamic impairment .
{ "P": [ "transient renal dysfunction" ], "I": [ "halothane", "isoflurane", "Halothane", "halothane group", "isoflurane group", "midazolam", "fentanyl", "pancuronium", "isoflurane in nitrous oxide and oxygen", "halothane-anesthetized", "anesthesia" ], "O": [ "transient renal dysfunction", "renal function", "renal hemodynamics", "Systemic hemodynamics", "effective renal plasma flow ( ERPF ) ( 131I-hippuran clearance )", "glomerular filtration rate ( GFR ) ( 99Tc-DTPA clearance )", "renal variables", "ERPF", "GFR", "transient renal vasoconstriction", "renal hemodynamic impairment" ] }
Family education for people with schizophrenia in Beijing , China : randomised controlled trial . BACKGROUND Much of China lacks well-developed services for people with schizophrenia and their families , and most of the existing services focus on hospitals . There is a need for culturally sensitive family treatments offered by nurses . AIMS To conduct a longitudinal experimental study examining the effect of patient and family education in a sample of Chinese people with schizophrenia . METHOD A randomised controlled trial was conducted in a large hospital with a was conducted in a large hospital with a sample of 101 patients with schizophrenia and their families . Data were collected at admission and at discharge , and then at 3 and 9 months after discharge . The intervention group received family education , and data on their knowledge about schizophrenia , symptoms , functioning , psychosocial behaviour , relapse and medication adherence were collected and compared with the control group . RESULTS There was a significant improvement in knowledge about schizophrenia in the experimental group and a significant difference in symptom scores and functioning at 9 months after discharge . Patients who were nonadherent to medication regimens were more likely to relapse . CONCLUSIONS Family education on schizophrenia by nurses in China was effective in improving knowledge and promoting improvement in patients ' symptoms .
{ "P": [ "people with schizophrenia", "schizophrenia", "101 patients" ], "I": [ "Family education", "family treatments", "patient and family education", "family education", "control" ], "O": [ "knowledge about schizophrenia , symptoms , functioning , psychosocial behaviour , relapse and medication adherence", "significant improvement in knowledge about schizophrenia", "significant difference in", "symptom scores and functioning", "relapse ." ] }
Prospective comparison of the value of brushings before and after biopsy in the endoscopic diagnosis of gastroesophageal malignancy . The hypothesis that the cytodiagnostic results on endoscopic brushings obtained before biopsy may be superior to those brushings obtained after biopsy , but with the accuracy of the subsequent biopsy reduced , was examined for 300 consecutive patients , including 256 with esophageal or gastric carcinomas . Following stratification by site and endoscopic appearance of their lesions , the patients were randomized to undergo brushing either before or after forceps biopsy . The accuracy of brushing cytology in patients with carcinoma was significantly higher when the brushing was performed before biopsy than after biopsy ( 93.5 % versus 82.6 % ; P less than .01 ) . The diagnostic yield of the biopsy was not significantly different whether the lesions were brushed before or after the biopsy ( 92.7 % versus 93.2 % ; P less than .5 ) . The diagnostic superiority of brushings obtained before biopsy did not relate to the site or endoscopic appearance of the tumor . There were no false-positive cytologic or histologic reports . For all 256 carcinomas , the cumulative accuracy ( brushing cytology plus biopsy ) reached 98.8 % and was significantly better ( P less than .001 ) than that of biopsy alone ( 93.9 % ) or cytology alone ( 87.9 % ) . Apart from reinforcing the belief that the combined application of brushing and biopsy is mandatory for achieving optimal results , this study indicated that the brushing should be performed before the biopsy .
{ "P": [ "gastroesophageal malignancy .", "300", "256", "esophageal or gastric carcinomas", "carcinoma" ], "I": [ "brushings before and after biopsy", "endoscopic brushings", "brushings", "undergo brushing either before or after forceps biopsy .", "brushing cytology", "brushings obtained before biopsy", "( brushing cytology plus biopsy )", "biopsy alone", "cytology alone", "combined application of brushing and biopsy" ], "O": [ "accuracy", "brushing cytology", "diagnostic yield", "no false-positive cytologic or histologic reports", "cumulative accuracy" ] }
Histopathologic changes of the eyelid skin following trichloroacetic acid chemical peel . The use of trichloroacetic acid ( TCA ) as a periorbital and eyelid peel for skin rejuvenation is gaining significant acceptance among oculoplastic surgeons , dermatologists , and other surgery groups . In spite of the current enthusiasm , there remain potentially serious complications resulting from any periorbital peel . Cases of cicatricial ectropion have been reported in phenol-peeled patients , and lower eyelid ectropion has reportedly occurred in patients undergoing deep eyelid peel in conjunction with a blepharoplasty ( 1,2 ) . To avoid this complication , it is necessary to better understand the depth of the wound produced by different strengths and combinations of peeling agents applied to living eyelid tissue and , more important , to determine the concentrations of TCA that are likely to lead to cicatricial ectropion when applied in a consistent fashion . We chose upper-eyelid skin because it is easier to obtain for histopathologic study than lower-eyelid skin and , in our experience , is more sensitive to hypertrophic changes after chemical peeling or carbon dioxide laser resurfacing . We applied TCA to the preseptal skin of 10 patients 48 h before standard upper-eyelid blepharoplasty . The acid was applied to produce a " frost , " using varying concentrations of acid , ranging from 20 to 50 % . The treated skin removed at the time of blepharoplasty was reviewed in a masked fashion by a dermatopathologist to determine the depth of necrosis . We found that superficial peels with necrosis involving 30 % of the epidermis were produced by the lowest-concentration combination of TCA applied ( 20 % followed by 0 % ) . As the strength increased , so did the depth of peel . The combination of 50 % followed by a second application of 50 % produced the deepest peel , with necrosis into the papillary dermis . This finding would indicate that the chance of developing cicatricial ectropion with any of the tested combinations of TCA should be very remote .
{ "P": [ "eyelid skin", "phenol-peeled", "deep eyelid peel", "10" ], "I": [ "trichloroacetic acid chemical peel", "trichloroacetic acid ( TCA )", "blepharoplasty", "TCA" ], "O": [ "Histopathologic changes of the eyelid skin", "superficial peels with necrosis", "applied", "strength increased", "deepest peel" ] }
A double-blind placebo-controlled pilot study of olanzapine in childhood/adolescent pervasive developmental disorder . Atypical antipsychotics have been shown to improve disruptive and repetitive behaviors in pervasive developmental disorders ( PDDs ) , but they require assessment of potential side effects . This is the first placebo-controlled trial of olanzapine in the treatment of children and adolescents with PDD . Eleven patients with a diagnosis of either autism , Asperger 's syndrome , or PDD not otherwise specified ( PDD-NOS ) and aged 6-14 years were randomized into an 8-week double-blind , placebo-controlled , parallel treatment study with olanzapine . There was a significant linear trend x group interaction on the Clinical Global Impressions- Improvement ( CGI-I ) and 50 % on olanzapine versus 20 % on placebo were responders . Olanzapine was associated with significant weight gain ( 7.5 +/- 4.8 lbs vs. 1.5 +/- 1.5 lbs on placebo ) . Olanzapine may be a promising treatment for improving global functioning of PDDs , but the risk of significant weight gain remains a concern . Additional studies are needed to determine the efficacy and safety of olanzapine in the treatment of children with PDD .
{ "P": [ "childhood/adolescent", "pervasive developmental disorder", "Eleven", "autism", "Asperger 's syndrome", "PDD", "PDD-NOS", "6-14 years" ], "I": [ "placebo-controlled", "olanzapine" ], "O": [ "disruptive and repetitive behaviors", "side effects", "Clinical Global Impressions- Improvement ( CGI-I )", "significant weight gain", "global functioning of PDDs", "weight gain" ] }
Superior efficacy of clopidogrel plus acetylsalicylic acid compared with extended-release dipyridamole plus acetylsalicylic acid in preventing arterial thrombogenesis in healthy volunteers . INTRODUCTION Recent ex vivo platelet aggregometry data indicate that clopidogrel 75 mg/day plus acetylsalicylic acid ( ASA ) 75 mg/day is a more potent antiplatelet regimen than the marketed combination of dipyridamole+ASA . The present study was designed to assess the antithrombotic effect of both dual antiplatelet regimens using a human ex vivo model of arterial thrombosis . MATERIALS AND METHODS This was a randomized , double-blind , placebo-controlled , crossover study . During two 10-day treatment periods separated by a 14-day washout period , 23 healthy male volunteers received once-daily clopidogrel 75 mg plus acetylsalicylic acid 75 mg , or twice-daily extended-release dipyridamole 200 mg plus acetylsalicylic acid 25 mg . Assessments were made at baseline and on Day 10 of each period . Arterial thrombus formation was induced ex vivo by exposing a collagen-coated surface in a parallel-plate perfusion chamber to native blood for 3 min ( arterial wall shear rate 2600 s ( -1 ) ) . Total platelet and fibrin deposition was determined by immunoenzymatic methods . RESULTS Compared with baseline values , the mean inhibition of total platelet deposition was 63.9+/-5.9 % with clopidogrel plus acetylsalicylic acid , compared with 18.4+/-5.6 % for extended-release dipyridamole plus acetylsalicylic acid ( 67 % reduction ; 95 % CI , 49-79 % ; p < 0.0001 ) . Corresponding figures for fibrin deposition were 64.9+/-4.8 % and 18.3+/-9.7 % , respectively ( 58 % reduction ; 95 % CI , 45-67 % ; p < 0.0001 ) . Both treatments were well tolerated . CONCLUSIONS Clopidogrel plus acetylsalicylic acid showed significantly superior antithrombotic efficacy compared with extended-release dipyridamole plus acetylsalicylic acid in preventing arterial thrombogenesis in humans .
{ "P": [ "healthy", "23", "male" ], "I": [ "clopidogrel plus acetylsalicylic acid", "extended-release dipyridamole plus acetylsalicylic acid", "clopidogrel", "plus acetylsalicylic acid ( ASA )", "dipyridamole+ASA", "dual antiplatelet regimens", "clopidogrel 75 mg plus acetylsalicylic acid", "extended-release dipyridamole 200 mg plus acetylsalicylic acid", "acetylsalicylic acid", "extended-release dipyridamole", "Clopidogrel" ], "O": [ "Total platelet", "fibrin deposition", "mean inhibition of total platelet deposition", "tolerated" ] }
Effects of telephone call interventions on patients ' well-being in a radiation therapy department . This study examined the effects of telephone call interventions by a collaborative team on patients ' well-being . Fifty-five subjects undergoing radiation therapy for cure and who were able to communicate by telephone comprised the sample . Subjects were randomly assigned to a control group , who received the usual care or to an experimental group , who received a weekly telephone call intervention in addition to the usual care . Speilberger 's State Trait Inventory , the Side Effects Profile , and the Coping Strategies Profile were used along with a telephone survey to collect data . Analysis of the data showed no significant differences between groups in anxiety , severity of side effects , helpfulness of self-care strategies , and coping strategies . However , the survey indicated that the telephone calls were clinically significant and provided a mechanism for demonstrating that the health care professionals cared about their patients and provided an opportunity for patients to talk about their concerns . The investigators believe that collaboration , caring , and communication are the essence of exemplary health care .
{ "P": [ "patients ' well-being in a radiation therapy department .", "patients ' well-being ." ], "I": [ "telephone call interventions", "control group , who received the usual care", "or to an experimental group , who received a weekly telephone call intervention in addition to the usual care" ], "O": [ "Speilberger 's State Trait Inventory", "the Side Effects Profile", "Coping Strategies Profile", "anxiety", "severity of side effects", "helpfulness of self-care strategies", "coping strategies", "clinically significant" ] }
Effect of cervical spine manipulative therapy on judo athletes ' grip strength . OBJECTIVE The objective of this study was to perform an investigation evaluating if cervical spinal manipulative therapy ( SMT ) can increase grip strength on judo athletes in a top 10 national-ranked team . METHODS A single-blinded , prospective , comparative , pilot , randomized , clinical trial was performed with 18 athletes of both sexes from a judo team currently competing on a national level . The athletes were randomly assigned to 2 groups : chiropractic SMT and sham . Three interventions were performed on each of the athletes at different time points . Force measurements were obtained by a hydraulic dynamometer immediately before and after each intervention at the same period before training up to 3 weeks with at least 36 hours between interventions . RESULTS Analysis of grip strength data revealed a statistically significant increase in strength within the treatment group after the first intervention ( 6.95 % right , 12.61 % left ) as compared with the second ( 11.53 % right , 17.02 % left ) and the third interventions ( 10.53 % right , 16.81 % left ) . No statistically significant differences were found in grip strength comparison within the sham group . Overall differences in strength were consistently significant between the study groups ( P = .0025 ) . CONCLUSION The present study suggests that the grip strength of national level judo athletes receiving chiropractic SMT improved compared to those receiving sham .
{ "P": [ "judo athletes", "18 athletes", "both sexes", "national level" ], "I": [ "cervical spine manipulative therapy", "cervical spinal manipulative therapy ( SMT )", "chiropractic SMT", "sham" ], "O": [ "grip strength", "data", "strength", "differences in" ] }
Comparison of percutaneous transmitral commissurotomy with Inoue balloon technique and metallic commissurotomy : immediate and short-term follow-up results of a randomized study . BACKGROUND The Inoue balloon technique for mitral commissurotomy is well established and carried out worldwide . Metallic commissurotomy is reported to be a cheaper and effective alternative to balloon mitral commissurotomy . METHODS One hundred patients were randomized into 2 groups to undergo percutaneous transmitral commissurotomy ( PTMC ) by means of the Inoue balloon technique ( IBMC , n = 49 ) or metallic commissurotomy ( PMMC , n = 51 ) . Patients were crossed over to the other technique when the initial technique was a failure . Success of valvotomy , procedure-related complications , and follow-up events of the 2 techniques were compared . RESULTS Basal echocardiographic and hemodynamic data were similar in both groups . Procedural success was similar in both groups : 45 of 49 procedures ( 91.8 % ) in the IBMC group , compared with 46 of 51 procedures ( 90.18 % ) in the PMMC group ( P = 1.0 ) . Crossover was also comparable , with 1 occurring in the IBMC group , compared with 3 in the PMMC group . Complications such as cardiac tamponade and mitral regurgitation ( requiring or not requiring mitral valve replacement ) were similar in both groups , with 3 complications in the IBMC group , compared with 4 complications in the PMMC group ( P =.29 ) . After a follow-up period of approximately 4 months , both groups had similar event rates and comparable hemodynamic parameters ( P = not significant ) . CONCLUSIONS Both IBMC and PMMC are successful means of providing relief from severe mitral stenosis with a gain in valve area and reduction in transmitral gradient . Both techniques have similar procedural success , complication rates , and follow-up events .
{ "P": [ "One hundred", "severe mitral stenosis" ], "I": [ "percutaneous transmitral commissurotomy ( PTMC )", "means of the Inoue balloon technique ( IBMC", "metallic commissurotomy ( PMMC", ", n = 51 )", "technique" ], "O": [ "Success of valvotomy", "procedure-related complications", "follow-up events", "Basal echocardiographic", "hemodynamic data", "cardiac tamponade and mitral regurgitation" ] }
Clinical effects of naltrexone on autistic behavior . Eight young adults who were diagnosed with autism were given the opiate antagonist naltrexone to control self-injurious behavior and maladaptive idiosyncratic mannerisms . The drug and placebo were administered in a double-blind crossover design over 17 weeks . Although one subject appeared to have partial decreases in maladaptive behaviors associated with naltrexone use , the drugs , as administered in this study , did not reduce the self-injurious and other maladaptive behaviors of the subjects .
{ "P": [ "autistic behavior .", "Eight young adults who were diagnosed with autism" ], "I": [ "naltrexone", "opiate antagonist naltrexone", "placebo" ], "O": [ "partial decreases in maladaptive behaviors", "reduce the self-injurious and other maladaptive behaviors" ] }
Paraesthesia during the needle-through-needle and the double segment technique for combined spinal epidural anaesthesia . Paraesthesia during regional anaesthesia is an unpleasant sensation for patients and , more importantly , in some cases it is related to neurological injury . Relatively few studies have been conducted on the frequency of paraesthesia during combined spinal epidural anaesthesia . We compared two combined spinal epidural anaesthesia techniques : the needle-through-needle technique and the double segment technique in this respect . We randomly allocated 116 parturients undergoing elective Caesarean section to receive anaesthesia using one of these techniques . Both techniques were performed using a 27G pencil point needle , an 18G Tuohy needle , and a 20G multiport epidural catheter from the same manufacturer . The overall frequency of paraesthesia was higher in the needle-through-needle technique group ( 56.9 % vs. 31.6 % , p = 0.011 ) . The frequency of paraesthesia at spinal needle insertion was 20.7 % in the needle-through-needle technique group and 8.8 % in the double segment technique group ; whereas the frequency of paraesthesia at epidural catheter insertion was 46.6 % in the needle-through-needle technique group and 24.6 % in the double segment technique group .
{ "P": [ "116 parturients undergoing elective Caesarean section to receive anaesthesia using one of these techniques ." ], "I": [ "needle-through-needle", "double segment technique", "spinal epidural anaesthesia", "the needle-through-needle technique and the double segment technique", "anaesthesia", "27G pencil point needle , an 18G Tuohy needle , and a 20G multiport epidural catheter", "needle-through-needle technique", "double segment" ], "O": [ "overall frequency of paraesthesia", "frequency of paraesthesia" ] }
Differential effects on bone density of progestogen-only methods for contraception in premenopausal women . The question of differential effects on bone density by two different types of progestogen-only methods for contraception in premenopausal women was addressed . Data from a prospective randomized clinical trial among 22 premenopausal women , age 32.6 ( range 20-45 years ) , who were randomly assigned to either of two treatments with continuous progestogens for contraception were analyzed ; depot-medroxyprogesterone acetate ( DMPA ) or continuous levonorgestrel treatment with subdermal implants ( Norplant ) , respectively . Forearm bone density ( BMDprox ) increased with 2.94 % ( p = 0.006 ) in women who were prescribed levonorgestrel , which was in contrast to stable values in those prescribed depot-medroxy-progesterone acetate ; group difference at 6 months for BMDprox 3.4 % ( 95 % CI 1.3 , 5.5 ; p = 0.025 ) and BMDdist 4.1 % ( 95 % CI - 1.3 , 9.6 ; p = 0.077 ) . The changes in bone density were consistent with the changes in biochemical indices for bone metabolism ; DMPA users showed signs of increased bone turnover and users of levonorgestrel showed increased bone formation with increased levels of both alkaline phosphatase ( p = 0.004 ) and osteocalcin ( p = 0.007 ) . The findings suggest an increase in bone density during treatment with levonorgestrel and stable values during short-term administration of DMPA , in standard clinical doses for contraception .
{ "P": [ "premenopausal women ." ], "I": [ "progestogen-only", "continuous progestogens", "depot-medroxyprogesterone acetate ( DMPA )", "continuous levonorgestrel treatment with subdermal implants", "depot-medroxy-progesterone acetate", "DMPA", "levonorgestrel" ], "O": [ "bone density", "Forearm bone density ( BMDprox )", "BMDprox", "BMDdist", "biochemical indices for bone metabolism", "bone turnover", "increased bone formation" ] }
Antihistaminics in idiopathic dystonia .
{ "P": [ "idiopathic dystonia ." ], "I": [ "Antihistaminics" ], "O": [] }
A randomized intervention to improve ongoing participation in mammography . OBJECTIVE To test the effectiveness of interventions intended to increase rates of regular breast cancer screening , according to recommended guidelines . STUDY DESIGN A randomized controlled trial of 2 outreach interventions ( a mail reminder and a telephone reminder plus appointment scheduling ) compared with a routine publicity campaign to encourage continued participation in mammography screening . PARTICIPANTS AND METHODS Participants were 1908 women aged 50 to 75 years continuously enrolled in a large group-model HMO during the study who underwent a bilateral mammogram during the first quarter of 1994 and no subsequent mammogram during the next 18 to 21 months . Data were obtained from health plan administrative data files supplemented by medical chart review . Women were randomly assigned to receive ( 1 ) a mail reminder , ( 2 ) a telephone reminder , or ( 3 ) routine publicity on mammography for all women . The outcome measure was a mammogram received after the intervention period and within 2 years of the initial mammogram date . RESULTS Bivariate and multivariate statistical analyses showed that participation was significantly higher for women contacted by telephone than through routine publicity . Mail reminders were no more effective than a routine publicity campaign . Primary care physician and gynecologist visits increased the likelihood of a subsequent mammogram for women in all intervention groups . CONCLUSIONS Telephone contact by regular health plan staff was more successful than publicity in encouraging continued participation in mammography screening in women enrolled in a group-model managed health care plan . Because mailings did not influence participation in mammography screening , health plans should be cautious about investing in member mailings without first evaluating their effectiveness in the context of existing outreach efforts .
{ "P": [], "I": [ "interventions intended", "outreach interventions ( a mail reminder and a telephone reminder plus appointment scheduling )", "routine publicity campaign", "mammography", "a mail reminder , ( 2 ) a telephone reminder , or ( 3 ) routine publicity on mammography for all women .", "routine publicity campaign .", "Telephone contact" ], "O": [ "ongoing participation in mammography", "rates of regular breast cancer screening", "continued participation in mammography screening", "mammogram received after the intervention period and within 2 years of the initial mammogram date", "subsequent mammogram", "mammography screening" ] }
5-fluorouracil plus folinic acid with or without ifosfamide in advanced colorectal cancer : a phase II randomized trial . AIM This phase II trial evaluated the biomodulation of 5-fluorouracil ( 5-FU ) plus folinic acid ( FA ) with or without ifosfamide ( IFO ) in chemotherapy-naive patients with colorectal cancer . PATIENTS AND METHODS Forty-eight patients were randomized to receive : FA ( 25 mg/m2 iv bolus days 1 to 3 ) , followed by 5-FU ( 750 mg/m2 iv bolus days 1 to 3 ) , arm A ; or FA ( 25 mg/m2 iv bolus days 1 to 3 ) , followed by 5-FU ( 750 mg/m2 iv bolus days 1 to 3 ) plus IFO ( 2,000 mg/m2 in 1000 mL 5 % dextrose in a 2-hr infusion , days 1 to 3 ) , arm B. Mesna was added during and after IFO to prevent hemorrhagic cystitis . Treatment was repeated every 21 days in both arms . RESULTS Forty-five patients were assessable for response : in arm A , 5 patients achieved a partial response ( overall response , 25 % ) , and in arm B , 2 patients achieved a complete and 1 a partial response ( overall response , 12 % ) . Time to failure was 3.5 months ( range , 1-38 ) in patients treated with 5-FU plus FA , and 3 months ( range , 1-21 ) in patients treated with the IFO combination . The median survival time was 13.5 months ( range , 1-49 months ) in arm A and 16 months ( range , 1-43 months ) in arm B . Diarrhea , stomatitis and vomiting were the most common nonhematologic toxicities in both arms . The most notable hematologic toxicity was leukopenia ; 15 % and 20 % of patients experienced grade 4 in arm A and arm B , respectively . CONCLUSIONS IFO does not increase the activity of the 5-FU plus FA combination in advanced colorectal cancer .
{ "P": [ "colorectal cancer", "Forty-eight", "Forty-five" ], "I": [ "5-fluorouracil", "folinic acid", "ifosfamide", "5-fluorouracil ( 5-FU )", "folinic acid ( FA", "FA", "5-FU", "IFO" ], "O": [ "partial response", "complete", "Time to failure", "median", "survival time", "Diarrhea", "stomatitis", "vomiting", "nonhematologic toxicities", "hematologic toxicity", "leukopenia", "advanced colorectal cancer" ] }
Computer Decision Support Changes Physician Practice But Not Knowledge Regarding Autism Spectrum Disorders . OBJECTIVE To examine whether adding an autism module promoting adherence to clinical guidelines to an existing computer decision support system ( CDSS ) changed physician knowledge and self-reported clinical practice . METHODS The CHICA ( Child Health Improvement through Computer Automation ) system , a CDSS , was enhanced with a module to improve management of autism in 2 of the 4 community pediatric clinics using the system . We examined the knowledge and beliefs of pediatric users using cross-sectional surveys administered at 3 time points ( baseline , 12 months and 24 months post-implementation ) between November 2010 and January 2013 . Surveys measured knowledge , beliefs and self-reported practice patterns related to autism . RESULTS A total of 45 , 39 , and 42 pediatricians responded at each time point , respectively , a 95-100 % response rate . Respondents ' knowledge of autism and perception of role for diagnosis did not vary between control and intervention groups either at baseline or any of the two post-intervention time points . At baseline , there was no difference between these groups in rates in the routine use of parent-rated screening instruments for autism . However , by 12 and 24 months post-implementation there was a significant difference between intervention and control clinics in terms of the intervention clinics consistently screening eligible patients with a validated autism tool . Physicians at all clinics reported ongoing challenges to community resources for further work-up and treatment related to autism . CONCLUSIONS A CDSS module to improve primary care management of ASD in pediatric practice led to significant improvements in physician-reported use of validated screening tools to screen for ASDs . However it did not lead to corresponding changes in physician knowledge or attitudes .
{ "P": [ "Physician Practice", "Autism Spectrum Disorders .", "CHICA ( Child Health Improvement through Computer Automation", "autism", "pediatric users", "45", "39", "42" ], "I": [ "Computer Decision Support", "computer decision support system", "CHICA ( Child Health Improvement through Computer Automation ) system", "CDSS" ], "O": [ "Practice", "Knowledge", "management of autism", "Surveys", "knowledge", "beliefs and self-reported practice patterns related to autism", "knowledge of autism and perception of role for diagnosis", "rates in the routine use of parent-rated screening instruments", "physician-reported use of validated screening tools", "physician knowledge or attitudes" ] }
Paracervical anesthesia for outpatient hysteroscopy . One hundred seventy-seven women aged 41 +/- 8 ( mean +/- SD ) years , referred for evaluation of excessive uterine bleeding , were enrolled in an open-label randomized trial to evaluate the efficacy of local anesthesia before hysteroscopy in an outpatient population . The patients underwent hysteroscopy and endometrial biopsy with paracervical block by 10 mL of 1 % mepivacaine hydrochloride solution ( n = 87 ) or no local anesthesia ( n = 90 ) and assessed lower abdominal and pelvic pain according to a 10-point linear analog scale . The mean +/- SD pain score was 4.5 +/- 2.0 at hysteroscopy and 5.2 +/- 2.1 at endometrial biopsy in the 87 subjects given a paracervical block versus 4.9 +/- 2.2 and 5.7 +/- 2.4 in the 90 women not given local anesthesia , without statistically significant differences . Paracervical anesthesia for routine outpatient hysteroscopy in premenopausal women may be superfluous .
{ "P": [ "One hundred seventy-seven", "women", "41 +/- 8", "excessive uterine bleeding", "premenopausal" ], "I": [ "local anesthesia", "hysteroscopy and endometrial biopsy", "paracervical block by 10 mL of 1 % mepivacaine hydrochloride solution", "no local anesthesia", "Paracervical anesthesia" ], "O": [ "outpatient hysteroscopy .", "hysteroscopy", "mean +/- SD pain score", "outpatient hysteroscopy" ] }
A randomised double-blind placebo-controlled trial investigating the behavioural effects of vitamin , mineral and n-3 fatty acid supplementation in typically developing adolescent schoolchildren . Nutrient deficiencies have been implicated in anti-social behaviour in schoolchildren ; hence , correcting them may improve sociability . We therefore tested the effects of vitamin , mineral and n-3 supplementation on behaviour in a 12-week double-blind randomised placebo-controlled trial in typically developing UK adolescents aged 13-16 years ( n 196 ) . Changes in erythrocyte n-3 and 6 fatty acids and some mineral and vitamin levels were measured and compared with behavioural changes , using Conners ' teacher ratings and school disciplinary records . At baseline , the children 's PUFA ( n-3 and n-6 ) , vitamin and mineral levels were low , but they improved significantly in the group treated with n-3 , vitamins and minerals ( P=0·0005 ) . On the Conners disruptive behaviour scale , the group given the active supplements improved , whereas the placebo group worsened ( F=5·555 , d=0·35 ; P=0·02 ) . The general level of disciplinary infringements was low , thus making it difficult to obtain improvements . However , throughout the school term school disciplinary infringements increased significantly ( by 25 % ; Bayes factor=115 ) in both the treated and untreated groups . However , when the subjects were split into high and low baseline infringements , the low subset increased their offences , whereas the high-misbehaviour subset appeared to improve after treatment . But it was not possible to determine whether this was merely a statistical artifact . Thus , when assessed using the validated and standardised Conners teacher tests ( but less clearly when using school discipline records in a school where misbehaviour was infrequent ) , supplementary nutrition might have a protective effect against worsening behaviour .
{ "P": [ "adolescent schoolchildren", "adolescents aged 13-16 years", "n 196" ], "I": [ "placebo-controlled", "vitamin , mineral and n-3 fatty acid supplementation", "vitamin , mineral and n-3 supplementation", "vitamin", "mineral", "vitamins and minerals" ], "O": [ "vitamin and mineral levels", "the Conners disruptive behaviour scale", "The general level of disciplinary infringements", "term school disciplinary infringements" ] }
A controlled study comparing patients with and without polycystic ovaries undergoing in-vitro fertilization . The outcome of in-vitro fertilization and embryo transfer ( IVF-ET ) was compared in 76 patients with polycystic ovaries ( PCO ) diagnosed on pre-treatment ultrasound scan , and 76 control patients who had normal ovaries and were matched for age , cause of infertility and stimulation regimen . Despite receiving significantly less human menopausal gonadotrophin ( HMG ) , patients with PCO , as compared with controls , had significantly higher serum oestradiol levels on the day of human chorionic gonadotrophin administration ( 5940 +/- 255 versus 4370 +/- 240 pmol/l , P < 0.001 ) , developed more follicles ( 14.9 +/- 0.7 versus 9.8 +/- 0.6 , P < 0.001 ) and produced more oocytes ( 9.3 +/- 0.6 versus 6.8 +/- 0.5 , P = 0.003 ) . However , fertilization rates were reduced in the PCO patients ( 52.8 +/- 3.4 % versus 66.1 +/- 3.4 % , P = 0.007 ) . There was no significant difference in cleavage rates . The pregnancy rate/embryo transfer was 25.4 % in the PCO group and 23.0 % in the group with normal ovaries . There were three high order multiple pregnancies in the PCO group compared with none in the group with normal ovaries . Of the PCO patients , 10.5 % developed moderate/severe ovarian hyperstimulation syndrome ( OHSS ) compared with none of the controls ( P = 0.006 ) . Patients with and without PCO undergoing IVF have comparable pregnancy and livebirth rates . However , it is important to diagnose PCO before ovarian stimulation is initiated as these patients are more likely to develop moderate or severe OHSS following IVF-ET .
{ "P": [ "polycystic ovaries", "76", "control", "PCO", "group with normal ovaries" ], "I": [ "in-vitro fertilization and embryo transfer ( IVF-ET )", "human menopausal gonadotrophin ( HMG )", "chorionic gonadotrophin" ], "O": [ "in-vitro fertilization .", "serum oestradiol levels", "follicles", "oocytes", "fertilization rates", "cleavage rates .", "pregnancy rate/embryo transfer", "ovarian hyperstimulation syndrome ( OHSS )", "pregnancy and livebirth rates ." ] }
Pharmacokinetics and pharmacodynamics of intravenous diltiazem in patients with atrial fibrillation or atrial flutter . BACKGROUND Diltiazem , a calcium channel blocker , has been shown to be safe and effective in the treatment of patients in atrial fibrillation and/or atrial flutter . However , there have been no pharmacokinetic/pharmacodynamic studies of diltiazem in these patients . METHODS AND RESULTS The pharmacokinetics and pharmacodynamics of intravenous diltiazem were determined in 32 patients with atrial fibrillation or atrial flutter ( mean +/- SD age , 66 +/- 7 years ; mean baseline heart rate , 131 +/- 10 beats per minute ) after 20 mg or 20 mg followed by 25-mg bolus doses and a 10 and 15 mg/hr infusion for 24 hours . After the 10 and 15 mg/hr infusions of diltiazem , mean +/- SD elimination half-life was 6.8 +/- 1.8 and 6.9 +/- 1.5 hours , volume of distribution was 411 +/- 151.8 and 299 +/- 70.8 I , and systemic clearance was 42 +/- 12.4 and 31 +/- 8.3 l/hr , respectively . Percentages of the plasma concentrations of the principal metabolites desacetyldiltiazem and N-desmethyldiltiazem to diltiazem were < 15 % and < 10 % , respectively . Thirty of 32 patients maintained response throughout the 24-hour infusion of diltiazem . Using a sigmoidal Emax pharmacodynamic model , a strong relation ( mean +/- SD r2 , 0.78 +/- 0.2 ) was observed between plasma diltiazem concentration and percent heart rate reduction . Mean +/- SD Emax ( maximum percent reduction in heart rate from baseline ) and EC50 ( plasma diltiazem concentration that achieves half Emax ) were 52 +/- 17 % and 110 +/- 84 ng/ml , respectively . The model predicts that mean plasma diltiazem concentration of 79 , 172 , and 294 ng/ml are required to produce a 20 % , 30 % , and 40 % reduction in heart rate , respectively . A relation between plasma diltiazem concentration and percent change in systolic blood pressure ( SBP ) or diastolic blood pressure ( DBP ) from baseline was not observed ( mean +/- SD r2 , SBP/DBP : 0.35 +/- 0.24/0.36 +/- 0.2 ) . There were no untoward side effects observed . CONCLUSIONS First , the pharmacokinetics of diltiazem in patients with atrial fibrillation or atrial flutter is nonlinear with an apparent dose-dependent decrease in systemic clearance with increasing infusion rate . Second , using a sigmoidal Emax model , there is a strong relation between plasma diltiazem concentration and percent heart rate reduction . Third , the plasma concentrations of the principal metabolites desacetyldiltiazem and N-desmethyldiltiazem are low and are not expected to contribute significantly to the pharmacodynamics of intravenous diltiazem in these patients .
{ "P": [ "patients with atrial fibrillation or atrial flutter .", "patients in atrial fibrillation and/or atrial flutter ." ], "I": [ "diltiazem", "Diltiazem", "intravenous diltiazem" ], "O": [ "Percentages of the plasma concentrations of the principal metabolites desacetyldiltiazem and N-desmethyldiltiazem to diltiazem", "plasma diltiazem concentration", "percent heart rate reduction", "EC50", "heart rate", "systolic blood pressure ( SBP )", "diastolic blood pressure ( DBP )" ] }
Comparison of insulin glargine and liraglutide added to oral agents in patients with poorly controlled type 2 diabetes . AIM To compare safety and efficacy of insulin glargine and liraglutide in patients with type 2 diabetes ( T2DM ) . METHODS This randomized , multinational , open-label trial included subjects treated for T2DM with metformin ± sulphonylurea , who had glycated haemoglobin ( HbA1c ) levels of 7.5-12 % . Subjects were assigned to 24 weeks of insulin glargine , titrated to target fasting plasma glucose of 4.0-5.5 mmol/L or liraglutide , escalated to the highest approved clinical dose of 1.8 mg daily . The trial was powered to detect superiority of glargine over liraglutide in percentage of people reaching HbA1c < 7 % . RESULTS The mean [ standard deviation ( s.d . ) ] age of the participants was 57 ( 9 ) years , the duration of diabetes was 9 ( 6 ) years , body mass index was 31.9 ( 4.2 ) kg/m ( 2 ) and HbA1c level was 9.0 ( 1.1 ) % . Equal numbers ( n = 489 ) were allocated to glargine and liraglutide . Similar numbers of subjects in both groups attained an HbA1c level of < 7 % ( 48.4 vs. 45.9 % ) ; therefore , superiority of glargine over liraglutide was not observed ( p = 0.44 ) . Subjects treated with glargine had greater reductions of HbA1c [ -1.94 % ( 0.05 ) and -1.79 % ( 0.05 ) ; p = 0.019 ] and fasting plasma glucose [ 6.2 ( 1.6 ) and 7.9 ( 2.2 ) mmol/L ; p < 0.001 ] than those receiving liraglutide . The liraglutide group reported a greater number of gastrointestinal treatment-emergent adverse events ( p < 0.001 ) . The mean ( s.d . ) weight change was +2.0 ( 4.0 ) kg for glargine and -3.0 ( 3.6 ) kg for liraglutide ( p < 0.001 ) . Symptomatic hypoglycaemia was more common with glargine ( p < 0.001 ) . A greater number of subjects in the liraglutide arm withdrew as a result of adverse events ( p < 0.001 ) . CONCLUSION Adding either insulin glargine or liraglutide to subjects with poorly controlled T2DM reduces HbA1c substantially , with nearly half of subjects reaching target levels of 7 % .
{ "P": [], "I": [ "insulin glargine", "liraglutide", "glargine" ], "O": [] }
Pre-treatment proliferation and the outcome of conventional and accelerated radiotherapy . This study investigated the influence of pre-treatment proliferation characteristics , assessed by Ki-67 staining , in patients treated in the CHART trial of accelerated radiotherapy in head and neck cancer . Histological material from 402 patients was collected and stained for the presence and pattern of Ki-67 staining . Locoregional control and overall survival were the main clinical endpoints . Increasing Ki-67 positivity was associated with decreasing differentiation ( P < 0.001 ) and increasing N-stage ( P < 0.004 ) . Increasing N-stage was also associated with the progression of proliferation pattern from marginal to random ( P < 0.001 ) . Using a multivariate model , a trend was seen towards a greater benefit from CHART in the lower Ki-67 tumours ( P = 0.08 ) ; this became significant by pooling the low and intermediate Ki-67 groups in comparison with the high Ki-67 group ( P = 0.032 ) . Tumours with marginal proliferation pattern showed a lower hazard ratio with CHART versus conventional for locoregional control ( P = 0.005 ) . The data presented in this study do not support that a high pre-treatment Ki-67 is associated with a therapeutic benefit from accelerated radiotherapy .
{ "P": [], "I": [ "conventional and accelerated radiotherapy", "assessed by Ki-67 staining", "accelerated radiotherapy" ], "O": [ "Locoregional control", "therapeutic benefit" ] }
Injection pain and postinjection pain of the palatal-anterior superior alveolar injection , administered with the Wand Plus system , comparing 2 % lidocaine with 1:100,000 epinephrine to 3 % mepivacaine . PURPOSE The purpose of this prospective , randomized , double-blind study was to compare injection pain and postinjection pain of 2 % lidocaine with 1:100,000 epinephrine and 3 % mepivacaine using the computer-assisted Wand Plus injection system to administer the palatal-anterior superior alveolar ( P-ASA ) injection . Additionally study was done to determine if the use of topical anesthetic decreased the pain of needle insertion with the P-ASA injection . STUDY DESIGN Using a crossover design , 40 subjects randomly received , in a double-blind manner , P-ASA injections of 1.4 mL of 2 % lidocaine with 1:100,000 epinephrine and 1.4 mL of 3 % mepivacaine , at 2 separate appointments . The P-ASA injection was administered , utilizing the Wand Plus system , 6 to 10 mm into the incisive canal located lingual to the central incisors . The pain of needle insertion , needle placement , solution deposition and postinjection pain were recorded on a Heft-Parker visual analog scale for the 2 P-ASA injections . Eighty injections were randomly administered in the study , 40 using topical anesthetic gel and 40 using a placebo gel . RESULTS For needle insertion , 30 % of the subjects reported moderate/severe pain with the lidocaine solution and 43 % reported moderate/severe pain with the mepivacaine solution . There was no significant difference ( P > .05 ) between the topical and placebo groups . For needle placement into the incisive canal , 54 % of the subjects reported moderate/severe pain with the lidocaine solution and 58 % reported moderate/severe pain with the mepivacaine solution . For anesthetic solution deposition , 8 % of the subjects reported moderate pain with the lidocaine solution and 12 % reported moderate pain with the mepivacaine solution . There were no significant differences ( P > .05 ) between the lidocaine and mepivacaine solutions . Regarding postinjection pain , when anesthesia wore off on the day of the injection , 20 % of the subjects reported moderate/severe pain with the lidocaine solution and 14 % reported moderate/severe pain with the mepivacaine solution . Pain ratings decreased over the next 3 days . There were no significant differences ( P > .05 ) between the lidocaine and mepivacaine solutions . Postinjection , 12 % and 18 % of the subjects experienced temporary numbness/paresthesia of the incisive papilla with the lidocaine and mepivacaine solutions , respectively . Twenty percent and 28 % of the subjects had incisive papilla swelling or soreness with the lidocaine and mepivacaine solutions , respectively . There were no significant differences ( P > .05 ) between the lidocaine and mepivacaine solutions . CONCLUSIONS The P-ASA injection of 1.4 mL of 2 % lidocaine with 1:100,000 epinephrine or 3 % mepivacaine , administered with the Wand Plus , has the potential to be a painful injection . The use of topical anesthetic did not significantly reduce pain of needle insertion when compared to a placebo . The incidence of postinjection pain , temporary numbness/paresthesia , and incisive papilla swelling or soreness would indicate that some pain and problems occur with the P-ASA technique , regardless of whether 2 % lidocaine with 1:100,000 epinephrine or 3 % mepivacaine is used .
{ "P": [ "40" ], "I": [ "lidocaine", "epinephrine", "mepivacaine", "topical anesthetic", "P-ASA injections of 1.4 mL of 2 % lidocaine", "topical anesthetic gel", "placebo gel", "placebo", "placebo ." ], "O": [ "Injection pain and postinjection pain", "injection pain", "postinjection pain", "pain", "pain of needle insertion , needle placement , solution deposition and postinjection pain", "moderate/severe pain", "moderate pain", "Pain ratings", "temporary numbness/paresthesia of the incisive papilla", "incisive papilla swelling", "soreness", "temporary numbness/paresthesia" ] }
Double-blind placebo-controlled trial of aprindine and digoxin for the prevention of symptomatic atrial fibrillation . A multicenter , placebo-controlled , randomized , double-blind trial compared the preventive effect of aprindine and digoxin on the recurrence of atrial fibrillation ( AF ) with placebo , and also compare the effectiveness of these 2 drugs in the prevention of AF . Patients with symptomatic paroxysmal or persistent AF who had converted to sinus rhythm ( SR ) were randomly assigned aprindine ( 40 mg/day ) , digoxin ( 0.25 mg/day ) or placebo and followed up on an outpatient basis every 2 weeks for 6 months . Of the 141 patients from 36 participating centers , 47 were given aprindine , 47 digoxin , and 47 were on placebo . After the 6-month follow-up , the Kaplan-Meier estimates of the percentage of patients remaining free of recurrent symptomatic AF on aprindine , digoxin and placebo were 33.3 % , 29.2 % and 21.5 % , respectively . In patients remaining in SR for 15 days after from the start of follow-up , freedom from recurrence was significantly more prevalent in the aprindine group than in the placebo group ( p=0.0414 ) , but there was no significant difference between the digoxin and placebo groups . The rate of adverse events was similar in the 3 groups . In conclusion , neither aprindine nor digoxin had a significant effect on preventing relapse of symptomatic AF ; however , recurrence of AF occurred later with aprindine than with placebo or digoxin .
{ "P": [ "symptomatic atrial fibrillation", "atrial fibrillation ( AF", "symptomatic paroxysmal", "persistent AF", "sinus rhythm ( SR", "141", "36", "47 were given aprindine", "47 digoxin", "47 were on placebo" ], "I": [ "placebo-controlled", "aprindine", "digoxin", "placebo" ], "O": [ "prevention of symptomatic atrial fibrillation .", "preventive effect", "recurrence of atrial fibrillation ( AF )", "effectiveness", "prevention of AF .", "Kaplan-Meier", "recurrent symptomatic AF", "freedom from recurrence", "significant difference", "rate of adverse events", "preventing relapse of symptomatic AF", "recurrence of AF" ] }
7-hexanoyltaxol-eluting stent for prevention of neointimal growth : an intravascular ultrasound analysis from the Study to COmpare REstenosis rate between QueST and QuaDS-QP2 ( SCORE ) . BACKGROUND Inhibition of neointimal tissue growth has been demonstrated in preliminary human feasibility studies with a stent-based polymer sleeve delivering 7-hexanoyltaxol . The Study to COmpare REstenosis rate between QueST and QuaDS-QP2 ( SCORE ) trial is a human , randomized , multicenter trial comparing 7-hexanoyltaxol ( QP2 ) -eluting stents ( qDES ) with bare metal stents ( BMS ) in the treatment of de novo coronary lesions . The purpose of this substudy was to evaluate the acute expansion property and long-term neointimal responses of qDES compared with BMS as assessed by intravascular ultrasound ( IVUS ) . METHODS AND RESULTS A total of 122 ( qDES 66 , BMS 56 ) patients were enrolled into the IVUS substudy . All IVUS images ( immediately after the procedure and at 6-month follow-up ) were analyzed at an independent core laboratory in a blind manner . At baseline , qDES achieved stent expansion similar to BMS . At follow-up , qDES showed reduced neointimal growth by 70 % at the tightest cross section and by 68 % over the stented segment ( P < 0.0001 for both ) , resulting in a significantly larger lumen in qDES than in BMS . Unlike intracoronary brachytherapy , there was no evidence of negative edge effects , unhealed dissections , or late stent-vessel wall malapposition over the stented and adjacent references segments in either group . CONCLUSIONS Detailed IVUS analysis revealed that qDES had comparable acute mechanical and superior long-term biological effects to BMS . Although the long-term benefits and limitations of this technology require further investigation , the reduction in neointimal thickenings demonstrated that local delivery of 7-hexanoyltaxol through polymer sleeves augments conventional mechanical treatment of atherosclerotic disease .
{ "P": [ "treatment of de novo coronary lesions", "122", "qDES 66", "BMS 56", "atherosclerotic disease" ], "I": [ "7-hexanoyltaxol-eluting stent", "stent-based polymer sleeve", "7-hexanoyltaxol", "7-hexanoyltaxol ( QP2 ) -eluting stents ( qDES ) with bare metal stents ( BMS )", "qDES", "BMS" ], "O": [ "acute expansion property", "long-term neointimal responses", "stent expansion", "neointimal growth", "negative edge effects", "unhealed dissections", "late stent-vessel wall malapposition" ] }
Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions : a randomized , double-blind , placebo-controlled , patient-initiated clinical trial . BACKGROUND Prior pilot studies support the use of antiviral medications with topical corticosteroids for herpes simplex labialis ( HSL ) . ME-609 ( Xerese , Xerclear ) is a combination of 5 % acyclovir and 1 % hydrocortisone developed for the topical treatment of HSL . OBJECTIVES The primary study end point was the prevention of ulcerative HSL lesions . METHODS In all , 2437 patients with a history of HSL were randomized to self-initiate treatment with ME-609 , 5 % acyclovir in ME-609 vehicle , or ME-609 vehicle ( placebo ) at the earliest sign of a cold sore recurrence . Cream was applied 5 times/d for 5 days . A total of 1443 patients experienced a recurrence and initiated treatment with ME-609 ( n = 601 ) , acyclovir ( n = 610 ) , or placebo ( n = 232 ) . RESULTS Of patients receiving ME-609 , 42 % did not develop an ulcerative lesion compared with 35 % of patients receiving acyclovir in ME-609 vehicle ( P = .014 ) and 26 % of patients receiving placebo ( P < .0001 ) . In patients with ulcerative lesions , healing times were reduced in the ME-609 and acyclovir groups compared with placebo ( P < .01 for both ) . The cumulative lesion area for all lesions was reduced 50 % in patients receiving ME-609 compared with the placebo group ( P < .0001 ) . There were no differences among groups in the number of patients with positive herpes simplex virus cultures . The side-effect profile was similar among treatments . LIMITATIONS The study did not contain a group treated with a topical corticosteroid alone . CONCLUSIONS ME-609 prevented progression of cold sores to ulcerative lesions and significantly reduced the cumulative lesion area compared with acyclovir and placebo . ME-609 treatment offers additional therapeutic benefit compared with therapy with topical acyclovir alone .
{ "P": [ "herpes simplex labialis", "2437", "history of HSL" ], "I": [ "ME-609", "ME-609 ( Xerese , Xerclear )", "acyclovir", "hydrocortisone", "randomized to self-initiate treatment with ME-609", "5 % acyclovir in ME-609 vehicle", "ME-609 vehicle ( placebo )", "Cream was applied 5 times/d for 5 days", "placebo", "acyclovir in ME-609 vehicle" ], "O": [ "frequency of ulcerative lesions :", "ulcerative HSL lesions .", "a recurrence", "ulcerative lesion", "healing times", "cumulative lesion area", "side-effect profile", "of cold sores to ulcerative lesions" ] }
Engagement with electronic screen media among students with autism spectrum disorders . This study investigated the relative engagement potential of four types of electronic screen media ( ESM ) : animated video , video of self , video of a familiar person engaged with an immersive virtual reality ( VR ) game , and immersion of self in the VR game . Forty-two students with autism , varying in age and expressive communication ability , were randomly assigned to the experimental conditions . Gaze duration and vocalization served as dependent measures of engagement . The results reveal differential responding across ESM , with some variation related to the engagement metric employed . Preferences for seeing themselves on the screen , as well as for viewing the VR scenarios , emerged from the data . While the study did not yield definitive data about the relative engagement potential of ESM alternatives , it does provide a foundation for future research , including guidance related to participant profiles , stimulus characteristics , and data coding challenges .
{ "P": [ "students with autism spectrum disorders ." ], "I": [ "Engagement with electronic screen media", "electronic screen media ( ESM ) : animated video , video of self , video of a familiar person engaged with an immersive virtual reality ( VR ) game , and immersion of self in the VR game .", "ESM", "VR" ], "O": [ "Gaze duration", "vocalization", "seeing themselves on the screen , as well as for viewing the VR scenarios" ] }