Seq Labeling Tasks
Collection
PICO stands for the framework is used in evidence-based medicine to frame and answer a clinical question.
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Treatments of preterm premature rupture of the membranes : a meta-analysis . The objective of this overview was to critically evaluate published randomized controlled trials on treatments in preterm premature rupture of the membranes . The Oxford data base on perinatal trials , MEDLINE , Excerpta Medica , and Index Medicus were searched . Through primary and secondary review with preset inclusion criteria , two independent judges identified 27 randomized controlled trials , of which 13 met inclusion criteria . The quality of these randomized controlled trials was scored . Five randomized controlled trials regarding antenatal use of corticosteroids to prevent respiratory distress syndrome could be combined meta-analytically and showed a reduction in respiratory distress syndrome in the treatment group ( p = 0.001 ) . However , no significant reduction in respiratory distress syndrome ( p = 0.286 ) was found after one study , with the lowest quality score , was excluded . A significant increase in endometritis and a trend toward an increase in neonatal infections and cesarean section rates were noted with treatment . Tocolysis , prophylactic antibiotics , and other interventions studied were not found to be of proved benefit and therefore should not be used outside of a randomized controlled trial .
|
{
"P": [
"preterm premature rupture of the membranes :",
"preterm premature rupture of the membranes ."
],
"I": [
"corticosteroids",
"Tocolysis , prophylactic antibiotics"
],
"O": [
"respiratory distress syndrome",
"endometritis",
"neonatal infections and cesarean section rates"
]
}
|
Nicardipine is superior to esmolol for the management of postcraniotomy emergence hypertension : a randomized open-label study . BACKGROUND Emergence hypertension after craniotomy is a well-documented phenomenon for which natural history is poorly understood . Most clinicians attribute this phenomenon to an acute and transient increase in catecholamine release , but other mechanisms such as neurogenic hypertension or activation of the renin-angiotensin-aldosterone system have also been proposed . In this open-label study , we compared the monotherapeutic antihypertensive efficacy of the 2 most titratable drugs used to treat postcraniotomy emergence hypertension : nicardipine and esmolol . We also investigated the effect of preoperative hypertension on postcraniotomy hypertension and the natural history of postcraniotomy hypertension in the early postoperative period . METHODS Fifty-two subjects were prospectively randomized to receive either nicardipine or esmolol as the sole drug for treatment of emergence hypertension at the conclusion of brain tumor resection ( 40 subjects finally analyzed ) . After a uniform anesthetic , standardized protocols of these antihypertensive medications were administered for the treatment of systolic blood pressure ( SBP ) > 130 , with the goal of maintaining SBP < 140 throughout the first postoperative day . In the event of study medication " failure , " a " rescue " antihypertensive ( labetalol or hydralazine ) was used . The O'Brien-Fleming Spending Function was used to calculate the appropriate α value for each interim analysis of the primary outcome ; univariate analysis was performed otherwise , with a 2-sided P < 0.05 considered statistically significant . RESULTS The incidence of nicardipine failure ( 5 % , 95 % confidence interval [ CI ] 0.1 % -24.9 % ) was significantly less than that of esmolol ( 55 % , 95 % CI 31.5 % -76.9 % ) as a sole drug in controlling SBP after brain tumor resection ( difference 99 % CI 13.8 % -75.7 % , P = 0.0012 ) . The presence of preoperative hypertension or the approach to surgery ( open craniotomy versus endonasal transsphenoidal ) had no significant effect on the incidence of failure of the antihypertensive regimen used . We did not observe a difference in the need for opioid therapy for postcraniotomy pain between drug groups ( 99 % CI difference -39.2 % -30.2 % ) . Failure of the study drug predicted the need for rescue drug therapy in the initial 12 hours after discharge from the recovery room ( difference success versus failure = -41.7 % , 99 % CI difference -72.3 % to -1.8 % , P = 0.0336 ) but not during the period 12 to 24 hours after discharge from the recovery room ( difference success versus failure = -27.4 % , 99 % CI difference -63.8 % -9.2 % , P = 0.143 ) . However , in those patients carrying a preoperative diagnosis of hypertension , the need for rescue medication was only different during the period 12 to 24 hours after discharge from the recovery room ( difference normotensive versus hypertensive = -35.4 % , 99 % CI difference -66.9 % to -0.3 % , P = 0.0254 ) . CONCLUSIONS Nicardipine is superior to esmolol for the treatment of postcraniotomy emergence hypertension . This type of hypertension is thought to be a transient phenomenon not solely related to sympathetic activation and catecholamine surge but also possibly encompassing other physiologic factors . For treating postcraniotomy emergence hypertension , nicardipine is a relatively effective sole drug , whereas if esmolol is used , rescue antihypertensive medications should be readily available .
|
{
"P": [
"emergence hypertension",
"hypertension",
"Fifty-two subjects",
"40"
],
"I": [
"Nicardipine",
"esmolol",
"nicardipine and esmolol",
"nicardipine or esmolol",
"( labetalol or hydralazine"
],
"O": [
"hypertension",
"systolic blood pressure ( SBP )",
"SBP",
"The incidence of nicardipine failure",
"of preoperative hypertension",
"the need for rescue drug therapy",
"the need for rescue medication"
]
}
|
[ Total parenteral nutrition in colon surgery ] .
|
{
"P": [
"colon surgery ]"
],
"I": [
"parenteral nutrition",
"colon surgery"
],
"O": [
"parenteral nutrition"
]
}
|
Pacifier as a risk factor for acute otitis media .
|
{
"P": [
"acute otitis media"
],
"I": [
"Pacifier"
],
"O": []
}
|
Effect of sensory stimulation ( acupuncture ) on sympathetic and parasympathetic activities in healthy subjects . UNLABELLED It has been postulated that sensory stimulation ( acupuncture ) affects the cardiovascular system via the autonomic nervous system . Previously , skin temperature , thermography , plethysmography and blood pressure changes have been used in evaluation of sympathetic nerve activity following acupuncture . By using power spectral analysis , the low frequency and high frequency components of heart rate variability can be calculated reflecting the sympathetic and parasympathetic activity . The purpose of this study was to investigate to what extent acupuncture applied into the thenar muscle and into the cavum concha of the ear induced changes in the sympathetic and/or parasympathetic nervous system in healthy subjects . MATERIALS AND METHODS Twelve healthy volunteers , six men and six women , mean age 34.4 ( range 23-48 ) participated in three balanced , randomly distributed sessions . At an individual initial visit the 12 volunteers were introduced to the needle sensation by having a needle inserted into the point LI 11 . The needle sensation was evoked and the subject was trained to identify the characteristic needle sensation . The introduction was followed by three test sessions . SESSION A A short acupuncture needle , ( Seirin no 3 , & emptyv ; 0.20x15 mm ) was inserted perpendicular into the earpoint , Lu 1 , in the left inferior hemi-conchae . SESSION B An acupuncture needle ( Hwato , & emptyv ; 0.30x30 mm ) was inserted perpendicular into the Hegu point ( LI 4 ) in the middle of the right dorsal thenar muscle . SESSION C An acupuncture needle ( Hwato , & emptyv ; 0.30x30 mm ) was inserted perpendicular superficially into the skin overlying the Hegu point on the left hand . Results . Stimulation of the ear induced a significant increase in the parasympathetic activity during the stimulation period of 25 min ( P < 0.05 ) and during the post-stimulation period of 60 min ( P < 0.05 ) . No significant changes were observed in either the sympathetic activity , blood pressure or heart rate . Stimulation of the thenar muscle resulted in a significant increase in the sympathetic and the parasympathetic activity during the stimulation period ( P < 0.01 ) and during the post-stimulation period ( P < 0.01 and P < 0.001 , respectively ) . A significant decrease in the heart rate frequency ( P < 0.05 ) at the end of the post-stimulation period was also demonstrated . The superficial needle insertion into the skin overlaying the right thenar muscle caused a pronounced balanced increase in both the sympathetic and parasympathetic activity during the post stimulation period of 60 min ( P < 0.01 ) while no changes were observed during the stimulation period . CONCLUSION It is indicated that sensory stimulation ( acupunctura ) in healthy persons is associated with changed activity in the sympathetic and parasympathetic nervous system depending on site of stimulation and period of observation .
|
{
"P": [
"healthy subjects .",
"Twelve healthy volunteers",
"six",
"men",
"women",
"mean age 34.4 ( range 23-48 )"
],
"I": [
"sensory stimulation",
"sensory stimulation ( acupuncture )",
"needle sensation",
"short acupuncture needle"
],
"O": [
"skin temperature",
"thermography",
"plethysmography",
"blood pressure",
"parasympathetic activity",
"sympathetic activity",
"heart rate",
"sympathetic and the parasympathetic activity",
"heart rate frequency",
"sympathetic",
"parasympathetic nervous"
]
}
|
Baseline distribution of participants with depression and impaired quality of life in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial . BACKGROUND Previous studies have demonstrated the psychosocial effect of heart failure in patients with reduced ejection fraction . However , the effects on patients with preserved ejection fraction have not yet been elucidated . This study aimed to determine the baseline characteristics of participants with heart failure with preserved ejection fraction as it relates to impaired quality of life ( QOL ) and depression , identify predictors of poor QOL and depression , and determine the correlation between QOL and depression . METHODS AND RESULTS Among patients enrolled in the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial ( TOPCAT ) , 3400 patients completed the Kansas City Cardiomyopathy Questionnaire , 3395 patients completed European QOL 5D Visual Analog Scale , and 1431 patients in United States and Canada completed the Patient Health Questionnaire-9 . The mean summary score on the Kansas City Cardiomyopathy Questionnaire was 54.8 , and on European QOL 5D Visual Analog Scale , it was 60.3 ; 27 % of patients had moderate to severe depression . Factors associated with better Kansas City Cardiomyopathy Questionnaire and European QOL 5D Visual Analog Scale via multiple logistic regression analysis were American region , older age , no history of angina pectoris or asthma , no use of hypoglycemic agent , more activity level , and lower New York Heart Association class . Factors associated with depression via multiple logistic regression analysis included younger age , female sex , comorbid angina , chronic obstructive pulmonary disease , use of a hypoglycemic agent , lower activity level , higher New York Heart Association class , and selective serotonin reuptake inhibitor use . There were significant correlations between each of the QOL scores and depression . CONCLUSIONS Patients with heart failure with preserved ejection fraction , who were younger had higher New York Heart Association class or comorbid angina pectoris , had lower activity levels , lived in Eastern Europe or were taking hypoglycemic agents , were more likely to have impaired QOL and depression . CLINICAL TRIAL REGISTRATION URL : http : //www.clinicaltrials.gov . Unique identifier : NCT00094302 .
|
{
"P": [
"depression",
"impaired quality of life",
"patients with reduced ejection fraction .",
"heart failure",
"preserved ejection fraction",
"Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial ( TOPCAT",
"3400 patients",
"younger",
"impaired QOL and depression"
],
"I": [
"Aldosterone Antagonist Trial ( TOPCAT )",
"European QOL 5D Visual Analog Scale"
],
"O": [
"Kansas City Cardiomyopathy Questionnaire",
"European QOL 5D Visual Analog Scale",
"Patient Health Questionnaire-9 .",
"QOL scores",
"depression"
]
}
|
Coping strategies as mediators of the effect of the START ( strategies for RelaTives ) intervention on psychological morbidity for family carers of people with dementia in a randomised controlled trial . BACKGROUND Family carers of people with dementia frequently become depressed or anxious . In observational studies , more emotion-focused and less dysfunctional coping predict fewer psychological symptoms , but no randomised controlled trial ( RCT ) has directly investigated emotion-focused coping as mediator of effectiveness of a successful psychological intervention . We hypothesised that emotion-focused coping would mediate the START psychological intervention׳s effects in an RCT . We tested whether mediated effects were moderated by severity of baseline symptoms . METHODS 260 family carers from NHS dementia services were randomised to START ( manualised coping skills intervention ) , or treatment-as-usual ( TAU ) . Blinded raters administered the Hospital Anxiety and Depression Scale ( HADS-T ) and Brief COPE inventory at baseline , 4 and 8 months . HADS-T improved in the intervention group when compared to TAU at all levels of psychological distress . We tested whether coping was a mediator and for moderated mediation , and ( post-hoc ) subgroup treatment effects on coping . RESULTS Data were available for 187 carers ( 71.9 % ) for the mediation analysis . The reduced HADS-T score in the intervention group was mediated by increased emotion-focused coping only among carers with higher ( 16+ ) baseline HADS-T scores ( mediated effect=-0.63 [ -1.11 , -0.15 ] ; proportion of overall effect=33 % [ 3 % , 64 % ] ) . LIMITATIONS We did not measure plausible psychosocial treatment mechanisms other than coping . CONCLUSIONS START benefited family carers both in preventing and treating psychological morbidity , through different mechanisms of action . The most psychologically distressed carers increased their emotion-focused coping and did not decrease their dysfunctional coping , while others benefited but not through this mechanism .
|
{
"P": [
"dementia",
"Family carers of people with dementia",
"260",
"187"
],
"I": [
"START ( strategies for RelaTives ) intervention",
"START"
],
"O": []
}
|
Transdermal nitroglycerin in angina pectoris : efficacy of intermittent application . Continuous application of transdermal nitroglycerin appears to result in tolerance to the antianginal effect . In a double-blind study the effects of continuous ( 24 h/day ) and intermittent ( 16 h/day ) application of transdermal nitroglycerin in a dosage of 10 mg/day were compared with the effects of placebo in 12 patients with chronic stable angina receiving treatment with beta-adrenergic blocking or calcium channel blocking agents . Exercise performance was assessed 2 to 4 hours after initial application and after 1 week of each treatment given in random order with a 3 day interval between treatments . Exercise time to onset of angina , total exercise duration and time to 1 mm ST segment depression were all significantly increased after initial application during the continuous and intermittent treatment periods . These increases were maintained after 1 week of intermittent but not continuous treatment . Thus the benefit of initial application of transdermal nitroglycerin is maintained with intermittent treatment and a daily nitrate-free interval , whereas tolerance to antianginal effect occurs with continuous treatment .
|
{
"P": [
"angina pectoris",
"12"
],
"I": [
"Transdermal nitroglycerin",
"transdermal nitroglycerin",
"transdermal nitroglycerin in",
"placebo",
"beta-adrenergic blocking",
"calcium channel blocking agents"
],
"O": [
"tolerance to the antianginal effect",
"Exercise performance",
"Exercise time to onset of angina , total exercise duration and time to 1 mm ST segment depression",
"tolerance to antianginal effect"
]
}
|
The safety and efficacy of terazosin in the treatment of essential hypertension in blacks . Terazosin , a new selective alpha 1-adrenergic receptor antagonist , has been found to be an effective antihypertensive agent . In a series of studies , the safety and efficacy of terazosin , alone and in combination with other antihypertensive agents , were evaluated in 1180 black patients with mild to moderate essential hypertension . Terazosin was effective in lowering blood pressure when administered alone ( in dosages of 1 to 80 mg/day ) and when prescribed ( in dosages of 1 to 20 mg/day ) in combination with other antihypertensive agents . In elderly black patients , terazosin , 1 to 10 mg daily , was as effective in lowering blood pressure as propranolol ( 40 to 120 mg twice daily ) . Changes ( mean +/- SE ) in sitting diastolic blood pressure from baseline were -8.1 +/- 1.4 mm Hg for terazosin and -5.0 +/- 1.5 mm Hg for propranolol . Terazosin ( 5 mg ) combined with methyclothiazide ( 2.5 to 5 mg ) produced a significantly greater ( p less than 0.01 ) antihypertensive effect than that of terazosin alone . Changes ( mean +/- SE ) in standing diastolic blood pressure from baseline were -7.9 +/- 2.0 mm Hg for terazosin alone , -15.1 +/- 2.1 mm Hg for terazosin plus 2.5 mg of methyclothiazide , and -15.0 +/- 2.0 mm Hg for terazosin plus 5 mg of methyclothiazide . Terazosin had a favorable effect on serum lipid levels and appeared to compensate for the negative lipid effects associated with diuretics and beta-blockers when used in combination with these agents . Terazosin , alone and combined with other antihypertensive agents , was well tolerated with minimal side effects in black hypertensive patients .
|
{
"P": [
"essential hypertension in blacks .",
"1180",
"mild to moderate essential hypertension",
"elderly",
"hypertensive"
],
"I": [
"terazosin",
"Terazosin",
"antihypertensive agents",
"propranolol",
"2.5 mg of methyclothiazide",
"methyclothiazide"
],
"O": [
"blood pressure",
"sitting diastolic blood pressure from baseline",
"antihypertensive effect",
"standing diastolic blood pressure from baseline",
"serum lipid levels",
"tolerated"
]
}
|
Differential effects of amino acid and ketoacid on protein metabolism in humans . We examined the effects of insulin , amino acid ( AA ) , and branched-chain ketoacid ( KA ) availability on leucine kinetics in eight healthy volunteers ( age = 22 +/- 2 y , body mass index = 24 +/- 1 kg ) by using the euglycemic insulin clamp and [ 1-14C ] leucine turnover techniques . Four experimental conditions were studied : study I , hyperinsulinemia ; study II , hyperinsulinemia with maintenance of basal plasma AA and branched-chain KA concentrations ; study III , hyperinsulinemia with hyperaminoacidemia and basal plasma branched-chain KA concentrations ; and study IV , hyperinsulinemia plus basal plasma AA concentrations and elevated branched-chain KA levels . Basal endogenous leucine flux ( ELF ) averaged 1.20 +/- 0.05 ( mumol.kg-1.min-1 , mean +/- SE ) ; basal leucine oxidation ( LOX ) was 0.25 +/- 0.01 ; and basal non-oxidative leucine disposal ( NOLD ) was 0.95 +/- 0.04 . ELF significantly decreased in study I ( 0.77 +/- 0.06 mumol.kg-1.min-1 , P < 0.01 versus basal ) . When plasma AA and branched-chain KA were either maintained at their basal levels ( study II ) or increased above baseline values ( studies III and IV ) , ELF declined further ( 0.64 +/- 0.05 , 0.66 +/- 0.02 , and 0.66 +/- 0.03 mumol.kg-1.min-1 , respectively ; all Ps < 0.01 versus basal and P < 0.01 versus study I ) . LOX declined in study I ( 0.12 +/- 0.02 mumol.kg-1.min-1 , P < 0.01 versus basal ) but increased significantly in studies II , III , and IV ( 0.31 +/- 0.04 , 0.37 +/- 0.03 , and 0.40 +/- 0.03 mumol.kg-1.min-1 , respectively , all Ps < 0.01 versus basal , P < 0.05 study IV versus study II , and P < 0.05 study III versus study II ) . NOLD declined in study I ( 0.65 +/- 0.05 mumol/kg.min , P < 0.01 versus basal ) , whereas neither the maintenance of basal plasma AA/branched-chain KA levels ( study II ; 0.89 +/- 0.2 mumol.kg-1.min-1 ) nor the elevation of plasma branched-chain KA concentration ( study IV ; 0.96 +/- 0.1 mumol.kg-1.min-1 ) increased NOLD above baseline level . A stimulation of NOLD was observed only when plasma AA levels were increased ( study III ; 1.23 +/- 0.03 mumol/kg.min , P < 0.01 versus basal ) . In conclusion , the present data do not support the concept of a direct anabolic action of ketoanalogs but do provide additional evidence for the pivotal role of AA availability in the stimulation of whole-body protein synthesis .
|
{
"P": [
"healthy volunteers",
"age = 22 +/- 2 y",
"body mass index = 24 +/- 1 kg"
],
"I": [
"euglycemic insulin clamp",
"and [ 1-14C ]",
"leucine turnover",
"techniques"
],
"O": [
"endogenous leucine flux ( ELF )",
"leucine oxidation ( LOX )",
"non-oxidative leucine disposal ( NOLD )",
"ELF",
"LOX",
"NOLD"
]
}
|
Synthetic serum substitute ( SSS ) : a globulin-enriched protein supplement for human embryo culture . OBJECTIVE The purpose of the present study was to evaluate whether an IVF protein supplement prepared from human serum albumin ( HSA ) and human globulins would retain performance characteristics equivalent to those reported for the commercial plasma expanders , Plasmatein ( Alpha Therapeutics , Los Angeles , California ) and Plasmanate ( Cutter Biological , Miles Inc. , Elkhart , Indiana ) . METHODS Pronuclear-stage human embryos were randomly divided and cultured in human tubal fluid medium ( HTF ) supplemented with either HSA ( 5 mg/mL ) or Plasmatein ( 10 % , v/v ; 5 mg/ml ) as a means of indirectly assessing the effect alpha- and beta-globulins have on embryonic development . Those results coupled with the known composition characteristics of Plasmatein were used as the starting basis to formulate test lots of synthetic serum substitute ( SSS ) . RESULTS Significantly ( P < 0.05 ) more of the human embryos cultured in Plasmatein supplemented medium reached the four-cell or greater stage by 40 hr postinsemination than a comparable group cultured in HSA alone . Lot 1 of SSS , formulated with HSA ( 84 % of total protein ) and human globulins ( 16 % of total protein ) and an aqueous lipoprotein fraction derived from human plasma ( Excyte IV ; Miles Diagnostics , Kankakee , Illinois ) , produced accelerated early embryonic growth relative to control murine embryos grown in the presence of Plasmatein , however , the percentage of the embryos reaching the hatched blastocyst stage was decreased ( 45 vs 100 % ) . Human embryos from seven patients , randomized to HTF medium supplemented with Plasmatein or lot 1 of SSS , showed equivalent growth at 36-40 hr postinsemination . A microprecipitate developed in media supplemented with lot 1 after several days of culture . The Excyte IV concentration was reduced and , ultimately , eliminated from the subsequent and final prototype lots of SSS . Murine embryos grown in the presence of lipoprotein free SSS showed significantly accelerated ( P < 0.01 ) growth at 17 hr postthaw compared to Plasmatein and all embryos progressed to hatching by 41 hr . Human embryos , randomized to either Plasmatein or lot 3 of SSS , showed significantly accelerated growth ( P < 0.01 ) when scored at 38 hr following insemination . CONCLUSION Synthetic serum substitute provides a convient , standardized means of adding protein to media used in assisted reproductive technology ( ART ) procedures .
|
{
"P": [
"seven"
],
"I": [
"Synthetic serum substitute ( SSS )",
"Plasmatein",
"Plasmanate",
"human tubal fluid medium ( HTF )",
"HSA ( 5 mg/mL )",
"( 10 % , v/v ; 5 mg/ml )",
"HSA",
"SSS",
"Synthetic serum substitute"
],
"O": [
"performance characteristics",
"four-cell or greater stage",
"early embryonic growth",
"growth",
"Excyte IV concentration",
"accelerated ( P < 0.01 ) growth",
"hatching",
"accelerated growth"
]
}
|
Chronic fatigue syndrome versus neuroendocrineimmune dysfunction syndrome : differential attributions . Since 1988 , when the term chronic fatigue syndrome ( CFS ) was coined , considerable discussion has occurred about stigma associated with this diagnostic term . In particular , patients with CFS have felt that this term trivializes the serious nature of this disorder . A Name Change Work group , appointed by the CFS Coordinating Committee , developed an umbrella term : chronic neuroendocrineimmune dysfunction syndrome ( CNDS ) , and proposed that there would be sub-types under this term , one being CFS . The present study examined attributions of this new umbrella term when compared with CFS . Nurses and physician assistants ( PAs ) were presented a case study of a patient with symptoms of CFS . They were told that the patient had either " chronic fatigue syndrome , " " chronic neuroendocrineimmune dysfunction syndrome , " or " chronic neuroendocrineimmune dysfunction syndrome , which had formerly been called chronic fatigue syndrome . " The different terms led to different attributions , with PA respondents rating the " CNDS " label as more severe . Results suggest that a more medical sounding term ( CNDS ) may lead to attributions that this syndrome is a more serious , disabling illness . The policy implications of these findings are discussed .
|
{
"P": [
"patients with CFS"
],
"I": [
"syndrome : differential attributions",
"case study of a patient with symptoms of CFS",
"medical sounding term ( CNDS )"
],
"O": [
"attributions",
"medical sounding term"
]
}
|
Motion style acupuncture treatment ( MSAT ) for acute low back pain with severe disability : a multicenter , randomized , controlled trial protocol . BACKGROUND Acupuncture is widely-used to treat patients with low back pain , despite insufficient evidence of the technique 's efficacy for acute back pain . Motion style acupuncture treatment ( MSAT ) is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture . In Korea , MSAT is used to reduce musculoskeletal pain and improve functional status . The study aims to evaluate the effect of MSAT on acute low back pain with severe disability . METHODS/DESIGN This study is a multicenter , randomized , active-controlled trial with two parallel arms . Participants with acute low back pain and severe functional disability , defined as an Oswestry Disability Index ( ODI ) value > 60 % , will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug ( NSAID ) injection group . The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac . All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation . The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale ( NRS ) of low back pain while the patient is moving . Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain , ODI , patient global impression of change , range of motion ( ROM ) of the lumbar spine , and degrees of straight leg raising ( SLR ) . Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2 , 4 , and 24 weeks after treatment . DISCUSSION The results of this trial will be discussed . TRIAL REGISTRATION ClinicalTrial.gov NCT01315561 .
|
{
"P": [
"acute low back pain",
"patients with low back pain",
"Korea",
"Participants with acute low back pain and severe functional disability"
],
"I": [
"Motion style acupuncture treatment ( MSAT )",
"acupuncture",
"nonsteroidal anti-inflammatory drug ( NSAID )",
"injection",
"MSAT",
"NSAID",
"diclofenac"
],
"O": [
"numerical rating scale ( NRS ) of low back pain",
"NRS of leg pain",
"ODI",
"patient global impression of change",
"range of motion ( ROM ) of the lumbar spine",
"degrees of straight leg raising ( SLR )",
"ROM",
"SLR"
]
}
|
Translucency of zirconia copings made with different CAD/CAM systems . STATEMENT OF PROBLEM Zirconia cores are reported to be less translucent than glass , lithium disilicate , or alumina cores . This could affect the esthetic appearance and the clinical choices made when using zirconia-based restorations . PURPOSE The purpose of this in vitro study was to evaluate the translucency of zirconia copings for single crowns fabricated using different CAD/CAM systems , using lithium disilicate glass ceramic as a control . MATERIAL AND METHODS Using impressions made from a stainless steel complete-crown master die , 9 stone cast replicas were fabricated , numbered , and distributed into 8 ceramic ZrO ( 2 ) CAD/CAM system groups ( Lava Frame 0.3 and 0.5 , IPS e.max ZirCAD , VITA YZ , Procera AllZircon , Digizon , DC Zircon , and Cercon Base ) and to a lithium disilicate glass-ceramic control group ( IPS e.max Press ) using a simple computer-generated randomization method . From each die , the manufacturer 's authorized milling centers supplied 5 copings per group without applying any dying technique to the ceramic base material . The copings were prepared to allow for a 40-mum cement layer and were of different thicknesses according to system specifications . Translucency was measured by the direct transmission method with a digital photoradiometer mounted in a dark chamber . The light source was a 150-W halogen lamp beam . Measurements were repeated 3 times for each specimen . Data obtained were analyzed using 1-way ANOVA and the Bonferroni multiple comparison test ( alpha=.05 ) . RESULTS Among ZrO ( 2 ) copings , Lava ( 0.3 mm and 0.5 mm thick ) showed the highest ( P < .05 ) values of translucency measured as light flow units ( 3.572 + or - 018 x 10 ( 3 ) lx and 3.181 + or - 0.13 x 10 ( 3 ) lx , respectively ) . These values represent 71.7 % and 63.9 % , respectively , of the glass-ceramic control group ( 4.98 x 10 ( 3 ) lx ) . CONCLUSIONS All ZrO ( 2 ) copings demonstrated different levels of light transmission , with the 2 Lava specimens showing the highest values . Translucency of zirconia copings was significantly lower ( P=.001 ) than that of the lithium disilicate glass-ceramic control .
|
{
"P": [
"zirconia copings",
"9"
],
"I": [
"zirconia copings",
"lithium disilicate glass ceramic"
],
"O": [
"translucency",
"Translucency",
"values of"
]
}
|
Monitoring tumour cells in the peripheral blood of small cell lung cancer patients . BACKGROUND Flow cytometry was used to enumerate tumour cells in longitudinal studies of peripheral blood from small cell lung cancer ( SCLC ) patients , together with magnetic bead selection to isolate and identify these cells . As part of a trial , 11 patients received either standard ( four weekly ) chemotherapy with ifosfamide , carboplatin , and etoposide ( ICE ) or accelerated ( two weekly ) ICE with filgrastim ( granulocyte colony-stimulating factor [ G-CSF ] ) and autologous stem cell support . METHODS Fresh venous blood was taken throughout treatment and follow-up . Aliquots were stained with a " tumour-specific " antibody against epithelial tissue ( Ber EP4 ) , verified as a good marker of SCLC cells by immunohistochemistry . Matched samples labelled with Ber EP4 were separated magnetically by adding a secondary bead-antibody conjugate for confirmation of tumour cell identity . RESULTS Circulating tumour cells were detected and monitored throughout treatment periods . An initial rise in circulating cells after the first cycle was followed by a fall in both treatment arms to baseline levels set by normal controls . This was achieved by week 12 in the accelerated treatment arm and by week 24 in the standard arm . CONCLUSIONS Flow cytometry and magnetic bead isolation can be used to identify changes in numbers of circulating tumour cells in patients undergoing chemotherapy for SCLC and thereafter during follow-up periods . Absence of tumour cells may indicate a more favourable patient group who would benefit from a more intense course of treatment .
|
{
"P": [],
"I": [
"Flow cytometry",
"chemotherapy",
"ifosfamide",
"carboplatin",
"etoposide ( ICE )",
"accelerated ( two weekly ) ICE with filgrastim",
"granulocyte colony-stimulating factor [ G-CSF ]",
"autologous stem cell support"
],
"O": [
"Circulating tumour cells",
"initial rise in circulating cells after the first cycle"
]
}
|
Impact of a 16-community trial to promote judicious antibiotic use in Massachusetts . OBJECTIVES Reducing unnecessary antibiotic use , particularly among children , continues to be a public health priority . Previous intervention studies have been limited by size or design and have shown mixed results . The objective of this study was to determine the impact of a multifaceted , community-wide intervention on overall antibiotic use for young children and on use of broad-spectrum agents . In addition , we sought to compare the intervention 's impact on commercially and Medicaid-insured children . METHODS We conducted a controlled , community-level , cluster-randomized trial in 16 nonoverlapping Massachusetts communities , studied from 1998 to 2003 . During 3 years , we implemented a physician behavior-change strategy that included guideline dissemination , small-group education , frequent updates and educational materials , and prescribing feedback . Parents received educational materials by mail and in primary care practices , pharmacies , and child care settings . Using health-plan data , we measured changes in antibiotics dispensed per person-year of observation among children who were aged 3 to < 72 months , resided in study communities , and were insured by a participating commercial health plan or Medicaid . RESULTS The data include 223,135 person-years of observation . Antibiotic-use rates at baseline were 2.8 , 1.7 , and 1.4 antibiotics per person-year among those aged 3 to < 24 , 24 to < 48 , and 48 to < 72 months , respectively . We observed a substantial downward trend in antibiotic prescribing , even in the absence of intervention . The intervention had no additional effect among children aged 3 to < 24 months but was responsible for a 4.2 % decrease among those aged 24 to < 48 months and a 6.7 % decrease among those aged 48 to < 72 months . The intervention effect was greater among Medicaid-insured children and for broad-spectrum agents . CONCLUSIONS A sustained , multifaceted , community-level intervention was only modestly successful at decreasing overall antibiotic use beyond substantial secular trends . The more robust impact among Medicaid-insured children and for specific medication classes provides an argument for specific targeting of resources for patient and physician behavior change .
|
{
"P": [
"16",
"children who were aged 3 to < 72 months",
"223,135"
],
"I": [
"multifaceted , community-wide intervention on overall antibiotic use",
"physician behavior-change strategy that included guideline dissemination , small-group education , frequent updates and educational materials , and prescribing feedback",
"educational materials by mail and in primary care practices , pharmacies , and child care settings"
],
"O": [
"Antibiotic-use rates",
"antibiotic prescribing",
"overall antibiotic use"
]
}
|
Wavefront-guided versus standard LASIK enhancement for residual refractive errors . OBJECTIVE To assess efficacy , safety , predictability , stability , and changes in higher-order aberrations ( HOAs ) and contrast sensitivity ( CS ) after wavefront-guided and standard LASIK enhancement for the correction of residual refractive errors . DESIGN Prospective , randomized , comparative clinical study . PARTICIPANTS Twenty eyes of 20 consecutive patients ( spherical equivalent [ SE ] , -2.01+/-1.36 diopters [ D ] ) treated with wavefront-guided Zyoptix Ablation Refinement software ( ZAR ) LASIK and 20 eyes of 20 consecutive patients ( SE , -1.81+/-1.21 D ) treated with standard Planoscan LASIK , both for residual refractive error enhancement . MAIN OUTCOME MEASURES Efficacy , safety , predictability , stability , HOAs , and CS were evaluated before and after enhancement at 6 months ' follow-up . METHODS Uncorrected visual acuity ( UCVA ) , best-corrected visual acuity ( BCVA ) , manifest refraction , CS by means of the Functional Acuity Contrast Test , and HOAs by means of Zywave aberrometry were evaluated preoperatively and 6 months after retreatment . RESULTS At 6 months postoperatively , UCVA was 20/25 or better in 100 % of the eyes . Efficacy indexes were 1.09 for ZAR patients and 0.95 for Planoscan patients . No eyes lost > or =1 line of BCVA ; in the ZAR group , 2 eyes gained 1 line and 6 eyes gained > or =2 lines ; in the Planoscan group , 3 eyes gained 1 line . The ZAR group showed a percentage of eyes ( 94.4 % ) within the 0.5-D range in SE higher than that shown by the Planoscan group ( 88.8 % ) . After 6 months , the HOA root mean square ( RMS ) increased on average by a factor of 1.44 for the Planoscan group ( P = 0.003 ) . No change or reduction in HOA RMS was found in the ZAR group ( factor of 0.96 ; P > 0.01 ) . Contrast sensitivity was reduced in the Planoscan group only at the highest spatial frequency ( 18 cycles per degree ; P < 0.01 ) . There was a significant reduction of CS as a function of HOA increase for the Planoscan group ( P < 0.0001 ) . No changes were observed for the ZAR group at any spatial frequency ( 1.5-18 cycles per degree ; P > 0.01 ) . CONCLUSIONS Wavefront-guided LASIK using the ZAR algorithm is an effective and safe procedure for treatment of residual refractive errors . Wavefront-guided LASIK does not increase HOAs and does not modify CS compared with preoperative values . Wavefront-guided LASIK seems to be better than standard LASIK for retreatments .
|
{
"P": [
"Twenty eyes of 20 consecutive patients",
"20 eyes",
"20 consecutive patients",
"residual refractive error enhancement"
],
"I": [
"Wavefront-guided",
"wavefront-guided Zyoptix Ablation Refinement software ( ZAR ) LASIK",
"ZAR",
"Planoscan",
"Wavefront-guided LASIK"
],
"O": [
"efficacy , safety , predictability , stability",
"changes in higher-order aberrations ( HOAs )",
"contrast sensitivity ( CS )",
"Efficacy , safety , predictability , stability",
"HOAs , and CS",
"Uncorrected visual acuity ( UCVA ) , best-corrected visual acuity ( BCVA ) , manifest refraction , CS by means of the Functional Acuity Contrast Test , and HOAs by means of Zywave aberrometry",
"UCVA",
"Efficacy indexes",
"No eyes lost",
"BCVA",
"HOA root mean square ( RMS )",
"reduction in HOA RMS",
"Contrast sensitivity",
"reduction of CS as a function of HOA increase",
"spatial frequency"
]
}
|
The short-term effects of transcranial direct current stimulation on electroencephalography in children with autism : a randomized crossover controlled trial . Abnormal synaptic maturation and connectivity are possible etiologies of autism . Previous studies showed significantly less alpha activity in autism than normal children . Therefore , we studied the effects of anodal tDCS on peak alpha frequency ( PAF ) related to autism treatment evaluation checklist ( ATEC ) . Twenty male children with autism were randomly assigned in a crossover design to receive a single session of both active and sham tDCS stimulation ( 11 mA ) over F3 ( left dorsolateral prefrontal cortex ) . Pre- to postsession changes in a measure of cortical activity impacted by tDCS ( PAF ) and ATEC were compared between groups . We also examined the associations between pre- and postsession changes in the PAF and ATEC . The results show significant pre- to postsession improvements in two domains of ATEC ( social and health/behavior domains ) following active tDCS , relative to sham treatment . PAF also significantly increased at the stimulation site , and an increase in PAF was significantly associated with improvements in the two domains of ATEC impacted by tDCS . The findings suggest that a single session of anodal tDCS over the F3 may have clinical benefits in children with autism and that those benefits may be related to an increase in PAF .
|
{
"P": [
"children",
"autism",
"Twenty",
"male"
],
"I": [
"transcranial direct current stimulation",
"anodal tDCS",
"active and sham tDCS stimulation"
],
"O": [
"changes in a measure of cortical activity",
"tDCS ( PAF )",
"ATEC",
"PAF",
"ATEC .",
"results show significant pre- to postsession improvements",
"two domains of ATEC ( social and health/behavior domains )",
"tDCS",
"increased",
"increase in PAF",
"clinical benefits",
"PAF ."
]
}
|
Tolerance and efficacy of combined diethylcarbamazine and albendazole for treatment of Wuchereria bancrofti and intestinal helminth infections in Haitian children . This randomized , placebo-controlled trial investigated the tolerance , efficacy , and nutritional benefit of combining chemotherapeutic treatment of intestinal helminths and lymphatic filariasis . Children were infected with Ascaris ( 30.7 % ) , Trichuris ( 53.4 % ) , and hookworm ( 9.7 % ) with 69.9 % having more than one of these parasites . A total of 15.8 % of the children had Wuchereria bancrofti microfilariae . Children were randomly assigned treatment with placebo , albendazole ( ALB ) , diethylcarbamazine ( DEC ) , or combined therapy . The combination of DEC/ALB reduced microfilarial density compared with placebo , ALB , or DEC ( P < or = 0.03 ) . Albendazole and DEC/ALB reduced the prevalence of Ascaris , Trichuris , and hookworm more than placebo or DEC ( P < or = 0.03 ) . Among Trichuris-infected children , those receiving ALB and DEC/ALB demonstrated greater gains in weight compared with placebo ( P < or = 0.05 ) . Albendazole and DEC/ALB were equally efficacious in treating intestinal helminths and for children with W. bancrofti microfilaremia , DEC/ALB was more effective than DEC , with no increase in severity of adverse reactions .
|
{
"P": [
"Wuchereria bancrofti and intestinal helminth infections",
"children",
"Children",
"infected with Ascaris ( 30.7 % ) , Trichuris ( 53.4 % ) , and hookworm ( 9.7 % ) with 69.9 % having more than one of these parasites",
"Wuchereria bancrofti microfilariae",
"Trichuris-infected",
"bancrofti microfilaremia"
],
"I": [
"combined diethylcarbamazine and albendazole",
"placebo-controlled",
"placebo",
"albendazole ( ALB )",
"diethylcarbamazine ( DEC ) ,",
"combined therapy",
"Albendazole",
"DEC/ALB",
"ALB",
"DEC"
],
"O": [
"Tolerance and efficacy",
"The combination of DEC/ALB reduced microfilarial density compared with placebo , ALB , or DEC ( P < or = 0.03 ) .",
"Albendazole and DEC/ALB reduced the prevalence of Ascaris , Trichuris , and hookworm more than placebo or DEC ( P < or = 0.03 ) . Among Trichuris-infected children , those receiving ALB and DEC/ALB demonstrated greater gains in weight compared with placebo ( P < or = 0.05 ) .",
"Albendazole and DEC/ALB were equally efficacious in treating intestinal helminths and for children with W.",
"bancrofti microfilaremia , DEC/ALB was more effective than DEC , with no increase in severity of adverse reactions ."
]
}
|
Pharmacodynamic analysis of intravenous recombinant urate oxidase using an indirect pharmacological response model in healthy subjects . AIM Pharmacodynamic analysis of intravenous recombinant urate oxidase produced by Escherichia coli was performed in healthy subjects using a pharmacokinetic/pharmacodynamic ( PK/PD ) model . METHODS A randomized , single-blind , placebo-controlled study was performed in 40 healthy Chinese subjects ( 4 groups of 10 subjects each , placebo 4:1 ratio ) who received infusions of uricase ( single doses of 0.1 , 0.2 , and 0.3 mg/kg ; multiple doses of 0.2 mg·kg ( -1 ) ·d ( -1 ) for 7 d ) . PK profiles were determined through plasma uricase activity , and PD profiles were established using uric acid levels in plasma and urine . The plasma PD parameter was estimated as changes in plasma uric acid levels as the effect in the indirect response model . Adverse events were also monitored . RESULTS A two-compartment PK model with constant iv input and first-order output was used to describe the kinetic process of plasma uricase . The low value ( 2.8 U/L ) of drug concentration that achieved 50 % of maximum effect ( EC50 ) indicated that low plasma uricase concentrations were sufficient to produce pharmacological effects . A strong relationship ( r ( 2 ) =0.9991 ) between the mean uric acid concentration in blood and the mean uric acid excretion rate in urine in the range of 11 to 30 h after single dosing was found . Infusions of uricase were well tolerated in all subjects . CONCLUSION The PK/PD model predicted the effective dose to be 0.1 mg/kg in healthy subjects . The excretion rate of uric acid in urine may be used as a new index for pharmacological effects in further clinical trials .
|
{
"P": [
"indirect pharmacological response model in healthy subjects .",
"healthy",
"pharmacokinetic/pharmacodynamic",
"40"
],
"I": [
"intravenous recombinant urate oxidase",
"placebo-controlled",
"uricase"
],
"O": []
}
|
Perceptual wind-up in the human oesophagus is enhanced by central sensitisation . BACKGROUND Oesophageal acid infusion induces enhanced pain hypersensitivity in non-acid exposed upper oesophagus ( secondary hyperalgesia ) in patients with non-cardiac chest pain , thus suggesting central sensitisation contributes to visceral pain hypersensitivity in functional gut disorders ( FGD ) . Perceptual wind-up ( increased pain perception to constant intensity sensory stimuli at frequencies > or=0.3 Hz ) is used as a proxy for central sensitisation to investigate pain syndromes where pain hypersensitivity is important ( for example , fibromyalgia ) . AIMS Wind-up in central sensitisation induced human visceral pain hypersensitivity has not been explored . We hypothesised that if wind-up is a proxy for central sensitisation induced human visceral pain hypersensitivity , then oesophageal wind-up should be enhanced by secondary hyperalgesia . METHODS In eight healthy volunteers ( seven males ; mean age 32 years ) , perception at pain threshold to a train of 20 electrical stimuli applied to the hand and upper oesophagus ( UO ) at either 0.1 Hz ( control ) or 2 Hz was determined before and one hour after a 30 minute lower oesophageal acid infusion . RESULTS Wind-up occurred only with the 2 Hz train in the UO and hand ( both p=0.01 ) . Following acid infusion , pain threshold decreased ( 17 ( 4 ) % ; p=0.01 ) in the UO , suggesting the presence of secondary hyperalgesia . Wind-up to the 2 Hz train increased in the UO ( wind-up ratio 1.4 ( 0.1 ) to 1.6 ( 0.1 ) ; p=0.03 ) but not in the hand ( wind-up ratio 1.3 ( 0.1 ) and 1.3 ( 0.1 ) ; p=0.3 ) CONCLUSION Enhanced wind-up after secondary oesophageal hyperalgesia suggests that visceral pain hypersensitivity induced by central sensitisation results from increased central neuronal excitability . Wind-up may offer new opportunities to investigate the contribution of central neuronal changes to symptoms in FGD .
|
{
"P": [
"human oesophagus",
"eight",
"healthy",
"seven",
"males",
"mean age 32 years"
],
"I": [
"electrical stimuli",
"2 Hz"
],
"O": [
"Perceptual wind-up",
"Wind-up",
"pain threshold decreased",
"Wind-up to the 2 Hz train",
"UO"
]
}
|
Enhancing antiepileptic drug adherence : a randomized controlled trial . Suboptimal adherence to antiepileptic drug ( AED ) treatment is commonplace , and increases the risk of status epilepticus and sudden unexplained death in epilepsy . This randomized controlled trial was designed to demonstrate whether an implementation intention intervention involving the completion of a simple self-administered questionnaire linking the intention of taking medication with a particular time , place , and other activity can improve AED treatment schedule adherence . Of the 81 patients with epilepsy who were randomized , 69 completed a 1-month monitoring period with an objective measure of tablet taking ( electronic registration of pill bottle openings , Medication Event Monitoring System [ MEMS ] ) . Intervention participants showed improved adherence relative to controls on all three outcomes : doses taken in total ( 93.4 % vs. 79.1 % ) , days on which correct dose was taken ( 88.7 % vs. 65.3 % ) , and doses taken on schedule ( 78.8 % vs. 55.3 % ) ( P < 0.01 ) . The implementation intention intervention may be an easy-to-administer and effective means of promoting AED adherence .
|
{
"P": [],
"I": [
"antiepileptic drug",
"antiepileptic drug ( AED ) treatment",
"self-administered questionnaire",
"AED",
"intention intervention"
],
"O": [
"improved adherence relative to controls",
"doses taken in total",
"correct dose was taken",
"doses taken on schedule"
]
}
|
Anxiety disorders in typically developing youth : autism spectrum symptoms as a predictor of cognitive-behavioral treatment . Symptoms of autism spectrum disorder ( ASD ) were assessed ( Social Responsiveness Scale-Parent ( SRS-P ) ; coded in-session behavior ) in typically-developing , anxiety-disordered children ( N = 50 ) treated with cognitive-behavioral therapy ( CBT ) . Study 1 : children with moderate autistic symptomology ( per SRS-P ) were significantly more likely to improve from family CBT ( FCBT ) than individual CBT ( ICBT ; OR = 8.67 ) . Coded behavior did not predict outcome . Study 2 : CBT components were compared by treatment and ASD symptom status . At-home exposure completion was greater in FCBT and there was an interaction in child involvement for treatment and ASD status . Though both treatments reduced anxiety , FCBT outperformed ICBT for children with moderate ASD symptoms , a benefit potentially linked to more at-home exposures and greater child involvement in FCBT .
|
{
"P": [],
"I": [
"cognitive-behavioral treatment"
],
"O": [
"At-home exposure completion",
"anxiety"
]
}
|
Topical retapamulin ointment ( 1 % , wt/wt ) twice daily for 5 days versus oral cephalexin twice daily for 10 days in the treatment of secondarily infected dermatitis : results of a randomized controlled trial . BACKGROUND New antibacterial agents with activity against pathogenic strains resistant to established antibiotics are needed to treat patients with secondarily infected dermatitis ( SID ) . OBJECTIVE We sought to determine the clinical safety and efficacy of topical retapamulin ointment 1 % versus oral cephalexin for the treatment of SID . METHODS Patients with SID were randomly assigned to retapamulin ointment 1 % ( twice daily [ bid ] ) for 5 days , or oral cephalexin ( 500 mg bid ) for 10 days . The primary efficacy end point was clinical response at follow-up . Secondary outcomes included microbiologic response at follow-up , safety , and compliance . RESULTS Retapamulin was as effective as cephalexin ( clinical success rates at follow-up : 85.9 % and 89.7 % , respectively ) . Microbiologic success rates at follow-up were 87.2 % for retapamulin and 91.8 % for cephalexin . Retapamulin was well tolerated and the topical formulation was preferred over the oral drug . LIMITATIONS An imbalance existed in the number of patients with the clinical outcome " unable to determine " ( 15 retapamulin , 2 cephalexin ) , mainly because of their failure to attend the study visit . If those who failed to attend visits ( who did not withdraw as a result of drug-related events ) are removed from the analysis , the clinical success rates are 89.9 % for retapamulin and 89.7 % for cephalexin . CONCLUSIONS Retapamulin ointment 1 % ( bid ) for 5 days was as effective as oral cephalexin ( bid ) for 10 days in treatment of patients with SID , and was well tolerated .
|
{
"P": [
"secondarily infected dermatitis :",
"patients with secondarily infected dermatitis ( SID ) .",
"Patients with SID",
"patients with SID"
],
"I": [
"Topical retapamulin ointment",
"cephalexin",
"topical retapamulin ointment",
"retapamulin ointment",
"oral cephalexin",
"Retapamulin",
"retapamulin",
"oral drug",
"Retapamulin ointment"
],
"O": [
"clinical response",
"microbiologic response",
"safety",
"compliance .",
"Microbiologic success rates",
"tolerated"
]
}
|
Factors associated with inadequate colorectal cancer screening with flexible sigmoidoscopy . BACKGROUND AND STUDY AIM Inadequate colorectal cancer screening wastes limited endoscopic resources . We examined patients factors associated with inadequate flexible sigmoidoscopy ( FSG ) screening at baseline screening and repeat screening 3-5 years later in 10 geographically-dispersed screening centers participating in the ongoing Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial . METHODS A total of 64,554 participants ( aged 55-74 ) completed baseline questionnaires and underwent FSG at baseline . Of these , 39,385 participants returned for repeat screening . We used logistic regression models to assess factors that are associated with inadequate FSG ( defined as a study in which the depth of insertion of FSG was < 50 cm or visual inspection was limited to < 90 % of the mucosal surface but without detection of a polyp or mass ) . RESULTS Of 7084 ( 11 % ) participants with inadequate FSG at baseline , 6496 ( 91.7 % ) had < 50 cm depth of insertion ( 75.3 % due to patient discomfort ) and 500 ( 7.1 % ) participants had adequate depth of insertion but suboptimal bowel preparation . Compared to 55-59 year age group , advancing age in 5-year increments ( odds ratios ( OR ) from 1.08 to 1.51 ) and female sex ( OR = 2.40 ; 95 % confidence interval ( CI ) : 2.27-2.54 ) were associated with inadequate FSG . Obesity ( BMI > 30 kg/m ( 2 ) ) was associated with reduced odds ( OR = 0.67 ; 95 % CI : 0.62-0.72 ) . Inadequate FSG screening at baseline was associated with inadequate FSG at repeat screening ( OR = 6.24 ; 95 % CI : 5.78-6.75 ) . CONCLUSIONS Sedation should be considered for patients with inadequate FSG or an alternative colorectal cancer screening method should be recommended .
|
{
"P": [
"Prostate , Lung , Colorectal , and Ovarian Cancer",
"64,554 participants",
"aged 55-74 )",
"39,385"
],
"I": [
"colorectal cancer screening with flexible sigmoidoscopy",
"flexible sigmoidoscopy",
"repeat screening",
"FSG",
"inadequate",
"alternative colorectal cancer screening method"
],
"O": [
"Obesity"
]
}
|
BNP-guided vs symptom-guided heart failure therapy : the Trial of Intensified vs Standard Medical Therapy in Elderly Patients With Congestive Heart Failure ( TIME-CHF ) randomized trial . CONTEXT It is uncertain whether intensified heart failure therapy guided by N-terminal brain natriuretic peptide ( BNP ) is superior to symptom-guided therapy . OBJECTIVE To compare 18-month outcomes of N-terminal BNP-guided vs symptom-guided heart failure therapy . DESIGN , SETTING , AND PATIENTS Randomized controlled multicenter Trial of Intensified vs Standard Medical Therapy in Elderly Patients With Congestive Heart Failure ( TIME-CHF ) of 499 patients aged 60 years or older with systolic heart failure ( ejection fraction < or = 45 % ) , New York Heart Association ( NYHA ) class of II or greater , prior hospitalization for heart failure within 1 year , and N-terminal BNP level of 2 or more times the upper limit of normal . The study had an 18-month follow-up and it was conducted at 15 outpatient centers in Switzerland and Germany between January 2003 and June 2008 . INTERVENTION Uptitration of guideline-based treatments to reduce symptoms to NYHA class of II or less ( symptom-guided therapy ) and BNP level of 2 times or less the upper limit of normal and symptoms to NYHA class of II or less ( BNP-guided therapy ) . MAIN OUTCOME MEASURES Primary outcomes were 18-month survival free of all-cause hospitalizations and quality of life as assessed by structured validated questionnaires . RESULTS Heart failure therapy guided by N-terminal BNP and symptom-guided therapy resulted in similar rates of survival free of all-cause hospitalizations ( 41 % vs 40 % , respectively ; hazard ratio [ HR ] , 0.91 [ 95 % CI , 0.72-1.14 ] ; P = .39 ) . Patients ' quality-of-life metrics improved over 18 months of follow-up but these improvements were similar in both the N-terminal BNP-guided and symptom-guided strategies . Compared with the symptom-guided group , survival free of hospitalization for heart failure , a secondary end point , was higher among those in the N-terminal BNP-guided group ( 72 % vs 62 % , respectively ; HR , 0.68 [ 95 % CI , 0.50-0.92 ] ; P = .01 ) . Heart failure therapy guided by N-terminal BNP improved outcomes in patients aged 60 to 75 years but not in those aged 75 years or older ( P < .02 for interaction ) CONCLUSION Heart failure therapy guided by N-terminal BNP did not improve overall clinical outcomes or quality of life compared with symptom-guided treatment . TRIAL REGISTRATION isrctn.org Identifier : ISRCTN43596477 .
|
{
"P": [],
"I": [
"Intensified vs Standard Medical Therapy",
"symptom-guided therapy",
"BNP-guided therapy"
],
"O": [
"18-month survival free of all-cause hospitalizations and quality of life as assessed by structured validated questionnaires .",
"survival free of all-cause hospitalizations",
"Patients ' quality-of-life metrics",
"survival free of hospitalization for heart failure",
"quality of life"
]
}
|
National Surgical Adjuvant Breast and Bowel Project 's Breast Cancer Prevention Trial . The Breast Cancer Prevention Trial is the largest breast cancer prevention study ever undertaken . Administered by the National Surgical Adjuvant Breast and Bowel Project , it is the first trial seeking to demonstrate whether a drug , tamoxifen , can prevent breast cancer in high-risk women . The objectives of this trial are to determine whether tamoxifen is effective in 1 ) reducing the incidence of invasive breast cancer , 2 ) reducing breast cancer mortality , 3 ) reducing deaths from cardiovascular disease , and 4 ) reducing bone fractures . In addition , the study will evaluate side effects , toxicity , and the quality of life of all study participants .
|
{
"P": [
"tamoxifen"
],
"I": [
"tamoxifen"
],
"O": [
"reducing the incidence of invasive breast cancer",
"reducing breast cancer mortality",
"reducing deaths from cardiovascular disease",
"reducing bone fractures",
"side effects ,",
"toxicity",
"quality of life"
]
}
|
Ketorolac versus fentanyl for gynaecological day-case surgery . The effectiveness of fentanyl and ketorolac in providing analgesia for day-case gynaecological procedures was evaluated in 55 healthy volunteers in a single blinded fashion . Fentanyl ( 1 mcg/kg iv ) and ketorolac ( 30 mg im ) were administered immediately following induction of anaesthesia . Anaesthesia was standardized with propofol , nitrous oxide and enflurane . Outcome variables assessed were pain , additional analgesic requirements , and incidence of postoperative nausea and vomiting . All variables were recorded at 15 minutes , 2 hours and 24 hours postoperatively . There was no significant difference between the 2 groups with respect to any of the measured variables . Both drugs were ineffective as sole analgesic agents in half of their respective groups . It may be that a combination of these drugs , providing a multireceptor approach to analgesia , will prove to be more effective .
|
{
"P": [
"gynaecological day-case surgery",
"day-case gynaecological procedures",
"55",
"healthy volunteers"
],
"I": [
"Ketorolac versus fentanyl",
"fentanyl",
"ketorolac",
"Fentanyl",
"propofol",
"nitrous oxide",
"enflurane"
],
"O": [
"pain",
"additional analgesic requirements",
"postoperative nausea and vomiting",
"ineffective",
"analgesic"
]
}
|
Enhancing the application and evaluation of a discrete trial intervention package for eliciting first words in preverbal preschoolers with ASD . This study evaluates the effectiveness of an intervention package including a discrete trial program ( Rapid Motor Imitation Antecedent Training ( Tsiouri and Greer , J Behav Educat 12:185-206 , 2003 ) combined with parent education for eliciting first words in children with ASD who had little or no spoken language . Evaluation of the approach includes specific intervention targets and functional spoken language outcomes ( Tager-Flusberg et al. , J Speech Lang Hear Res 52:643-652 , 2009 ) . Results suggest that RMIA , with parent training , catalyzes development of verbal imitation and production for some children . Three of five participants acquired word production within the DTT framework and achieved milestones of early functional spoken language use ( Tager-Flusberg et al. , J Speech Lang Hear Res 52:643-652 , 2009 ) . The implications of these findings for understanding the role of discrete trial approaches to language intervention are discussed .
|
{
"P": [
"preverbal preschoolers",
"ASD",
"children",
"little or no spoken language",
"Three of five"
],
"I": [
"discrete trial intervention package",
"discrete trial program ( Rapid Motor Imitation Antecedent Training",
"combined with parent education for"
],
"O": [
"functional spoken language outcomes ( Tager-Flusberg et al.",
"J Speech Lang Hear Res 52:643-652 , 2009 )",
"verbal imitation and production",
"word production",
"early functional spoken language use"
]
}
|
Secretin and sleep in children with autism . The objectives of this pilot study were 1 ) to examine possible effects of secretin infusions on sleep-wake state organization in children with autism , and 2 ) to assess the feasibility of home recordings using time-lapse videosomnography in children with autism . Participants were a subset of subjects from two double blind , placebo-control , multi-center clinical trials . One trial , the UC Irvine study , assessed the effects of porcine secretin vs. saline infusions on children 's behavior , language and IQ . The UC Davis trial assessed the effects of synthetic human secretin vs. saline infusions on behavior , language and gastrointestinal function . The sleep study enrolled some of the children from each of the two trials to observe possible secretin effects on sleep . To examine sleep , the UC Irvine trial used the Children 's Sleep Habits Questionnaire and daily sleep diaries , whereas the UC Davis study used home-recorded time-lapse videosomnography . Because of the small sample size , the results from both trials are preliminary . They suggest that secretin , porcine or synthetic , does not improve sleep-wake state organization dramatically .
|
{
"P": [],
"I": [
"Secretin",
"secretin",
"porcine secretin",
"saline infusions",
"synthetic human secretin",
"secretin , porcine or synthetic"
],
"O": [
"behavior , language",
"IQ",
"gastrointestinal function .",
"Children 's Sleep Habits Questionnaire and daily sleep diaries",
"home-recorded time-lapse videosomnography",
"sleep-wake state organization"
]
}
|
Effects of a common variant in the CD38 gene on social processing in an oxytocin challenge study : possible links to autism . The intranasal application of oxytocin ( OT ) has been shown to influence behavioral and neural correlates of social processing . These effects are probably mediated by genetic variations within the OT system . One potential candidate could be the CD38 gene , which codes for a transmembrane protein engaged in OT secretion processes . A common variation in this gene ( rs3796863 ) was recently found to be associated with autism spectrum disorders ( ASD ) . Using an imaging genetics approach , we studied differential effects of an intranasal OT application on neural processing of social stimuli in 55 healthy young men depending on their CD38 gene variant in a double-blind placebo-controlled crossover design . Genotype had a significant influence on both behavioral and neuronal measures of social processing . Homozygotic risk allele carriers showed slower reaction times ( RT ) and higher activation of left fusiform gyrus during visual processing of social stimuli . Under OT activation differences between genotypes were more evident ( though not statistically significantly increased ) and RT were accelerated in homozygotic risk allele carriers . According to our data , rs3796863 mainly influences fusiform gyrus activation , an area which has been widely discussed in ASD research . OT seems to modulate this effect by enhancing activation differences between allele groups , which suggests an interaction between genetic makeup and OT availability on fusiform gyrus activation . These results support recent approaches to apply OT as a pharmacological treatment of ASD symptoms .
|
{
"P": [],
"I": [
"oxytocin",
"oxytocin ( OT )",
"OT application",
"placebo-controlled",
"OT",
"pharmacological treatment"
],
"O": [
"social processing",
"behavioral and neural correlates of social processing .",
"neural processing of social stimuli",
"behavioral and neuronal measures of social processing .",
"slower reaction times ( RT )",
"higher activation of left fusiform gyrus",
"social stimuli",
"activation differences",
"rs3796863 mainly influences fusiform gyrus activation",
"genetic makeup",
"OT availability",
"fusiform gyrus activation"
]
}
|
Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia . OBJECTIVE To assess the efficacy of moderate aerobic physical activity with sleep hygiene education to improve sleep , mood and quality of life in older adults with chronic insomnia . METHODS Seventeen sedentary adults aged > or=55 years with insomnia ( mean age 61.6 [ SD±4.3 ] years ; 16 female ) participated in a randomized controlled trial comparing 16 weeks of aerobic physical activity plus sleep hygiene to non-physical activity plus sleep hygiene . Eligibility included primary insomnia for at least 3 months , habitual sleep duration < 6.5h and a Pittsburgh Sleep Quality Index ( PSQI ) score > 5 . Outcomes included sleep quality , mood and quality of life questionnaires ( PSQI , Epworth Sleepiness Scale [ ESS ] , Short-form 36 [ SF-36 ] , Center for Epidemiological Studies Depression Scale [ CES-D ] ) . RESULTS The physical activity group improved in sleep quality on the global PSQI ( p < .0001 ) , sleep latency ( p=.049 ) , sleep duration ( p=.04 ) , daytime dysfunction ( p=.027 ) , and sleep efficiency ( p=.036 ) PSQI sub-scores compared to the control group . The physical activity group also had reductions in depressive symptoms ( p=.044 ) , daytime sleepiness ( p=.02 ) and improvements in vitality ( p=.017 ) compared to baseline scores . CONCLUSION Aerobic physical activity with sleep hygiene education is an effective treatment approach to improve sleep quality , mood and quality of life in older adults with chronic insomnia .
|
{
"P": [
"older adults",
"insomnia",
"Seventeen",
"adults",
"> or=55 years",
"61.6 [ SD±4.3 ] years",
"female",
"chronic insomnia"
],
"I": [
"Aerobic exercise",
"moderate aerobic physical activity"
],
"O": [
"self-reported sleep",
"quality of life",
"efficacy",
"improve sleep , mood"
]
}
|
Comparison of indicators for a primary care medical home between children with autism or asthma and other special health care needs : National Survey of Children 's Health . OBJECTIVE To assess the extent to which parents of children with autism compared with parents of children with asthma or other special health care needs report receiving primary care for their child consistent with the American Academy of Pediatrics medical home model . DESIGN Population-based cross-sectional study . SETTING National Survey for Children 's Health 2003-2004 telephone interview . PARTICIPANTS Parents of 495 children with autism , parents of 6716 children with asthma , and parents of 11,403 children with other special health care needs without asthma . Main Exposures Autism and other special health care needs including asthma . MAIN OUTCOME MEASURES Medical home score and components of care , as follows : personal provider and preventive ; family-centered , compassionate , and culturally appropriate ; accessible ; comprehensive ; and coordinated . RESULTS The odds of parents reporting care consistent with that in a medical home were less likely for children with autism ( odds ratio , 0.45 ; 95 % confidence interval , 0.30-0.66 ) and more likely for children with asthma ( odds ratio , 1.17 ; 95 % confidence interval , 1.06-1.30 ) compared with children with other special health care needs ( 1 [ reference ] ) . These differences persisted even after controlling for condition severity , personal characteristics , and insurance status . Specific components of a medical home less prevalent among children with autism than among children with other special health care needs included family-centered , comprehensive , and coordinated care . CONCLUSION Although we could not evaluate the reasons why , a large percentage of children with autism do not receive primary care consistent with that in a medical home .
|
{
"P": [
"children",
"autism",
"asthma",
"special health care needs",
"495",
"6716",
"11,403"
],
"I": [
"National Survey for Children 's Health 2003-2004 telephone interview"
],
"O": [
"odds of parents reporting care consistent with that in a medical home",
"less likely for children with autism",
"primary care consistent with that in a medical home"
]
}
|
Effect of soy protein containing isoflavones on blood lipids in moderately hypercholesterolemic adults : a randomized controlled trial . BACKGROUND Dietary intake of soy protein with isoflavones may be associated with reductions in serum cholesterol . OBJECTIVES To compare the effects of a water-washed soy protein concentrate with a milk-protein based control on blood lipid levels in hyperlipidemic men and women . METHODS A randomized , double-blind , controlled clinical trial including 159 subjects . After a 3-week run-in period during which all subjects consumed a milk protein-based supplement , participants were randomized into one of two groups : a control group ( continued milk protein ) and an intervention group ( soy protein ) for a five-week period . Fasting venous blood draws for lipid measurement were obtained at baseline , towards the end of the run-in period and at the end of the intervention . Blood isoflavone concentrations were measured at the end of the study . RESULTS Blood lipid levels were not significantly different between groups at any point in time ; and there were no significant associations between blood isoflavones and lipid levels . Significant decreases in total cholesterol ( 19 mg/dL ) , and LDL-cholesterol ( 11 mg/dL ) , were observed during the run-in period , with no further decreases in lipids during the intervention period in either group . CONCLUSIONS These results do not support the hypothesis that water-washed soy protein has an effect on blood lipids . Several hypotheses are discussed , highlighting the selective nature of the effect of soy consumption in the population . The cholesterol-lowering effect during the run-in period may be explained by the " regression to the mean effect " and by other factors related to study participation , mainly nutrient displacement induced by the protein supplement .
|
{
"P": [
"hypercholesterolemic",
"adults",
"hyperlipidemic",
"men",
"women .",
"159"
],
"I": [
"soy protein containing isoflavones",
"Dietary intake",
"soy protein with isoflavones",
"water-washed soy protein concentrate",
"milk-protein based control",
"milk protein-based supplement",
"continued milk protein",
"soy protein",
"isoflavone",
"isoflavones",
"protein supplement"
],
"O": [
"blood lipids",
"Blood isoflavone concentrations",
"Blood lipid levels",
"blood isoflavones",
"lipid levels",
"decreases",
"total cholesterol",
"LDL-cholesterol"
]
}
|
Effect of thermal stress , restricted feeding and combined stresses ( thermal stress and restricted feeding ) on growth and plasma reproductive hormone levels of Malpura ewes under semi-arid tropical environment . A study was conducted to assess the effect of thermal , nutritional and combined stresses ( thermal and nutritional ) on the growth , oestradiol and progesterone levels during oestrus cycles in Malpura ewes . Twenty-eight adult Malpura ewes were used in the present study . The ewes were randomly allocated into four groups , viz. , GI ( n=7 ; control ) , GII ( n=7 ; thermal stress ) , GIII ( n=7 ; restricted feeding ) and GIV ( n=7 ; combined stress ) . The animals were stall fed with a diet consisting of 60 % roughage and 40 % concentrate . GI and GII ewes were provided with ad libitum feeding while GIII and GIV ewes were provided with restricted feed ( 30 % intake of GI and GII ewes ) to induce nutritional insufficiency . GII and GIV ewes were kept in climatic chamber at 40°C and 55 % RH for 6 h a day between 10:00 and 16:00 hours to induce thermal stress for a period of two oestrous cycles . Parameters studied were body weight , oestrus incidences , plasma oestradiol 17-β , plasma progesterone , conception rate , gestation period , lambing rate , and birth weight of lambs . The results indicate that combined stress significantly ( p < 0.05 ) reduced body weight , oestrus duration , birth weight of lambs , and oestradiol 17-β whereas significantly ( p < 0.05 ) increased oestrus cycle length and progesterone . Furthermore , the results reveal that on comparative basis , ewes were able to better adapt in terms of growth and reproduction to restricted feeding than thermal stress . However , when restricted feeding was coupled with thermal stress it had significant ( p < 0.05 ) influence on body weight , average daily gain , oestradiol 17-β and progesterone concentrations . This showed that combined stress were more detrimental for these reproductive hormones in Malpura ewes under a hot semi-arid environment .
|
{
"P": [
"Twenty-eight",
"adult"
],
"I": [
"restricted feeding",
"combined stresses ( thermal stress and restricted feeding )",
"control )",
"thermal stress )",
"restricted feeding )",
"combined stress )",
"stall fed with a diet consisting of 60 % roughage and 40 % concentrate ."
],
"O": [
"body weight , oestrus incidences , plasma oestradiol 17-β , plasma progesterone , conception rate , gestation period , lambing rate , and birth weight of lambs",
"body weight , oestrus duration , birth weight of lambs , and oestradiol"
]
}
|
Transdermal scopolamine patch in addition to ondansetron for postoperative nausea and vomiting prophylaxis in patients undergoing ambulatory cosmetic surgery . STUDY OBJECTIVE To determine the efficacy of transdermal scopolamine in addition to ondansetron in decreasing the incidence of postoperative nausea and vomiting ( PONV ) . DESIGN Randomized controlled trial . SETTING Academic hospital . PATIENTS 126 ASA physical status I and II patients undergoing outpatient plastic surgery with three or more risk factors for PONV . INTERVENTIONS Patients were randomly assigned to one of two groups to receive ( Group 1 ) a transdermal scopolamine ( TDS ) patch or ( Group 2 ) , a placebo patch two hours before surgery . MEASUREMENTS Occurrence of vomiting , severity of nausea using a visual analog scale ( VAS ) , rescue medication , pain intensity and pain medications , and side effects were recorded every hour until discharge from hospital , then every 4 hours thereafter for a total of 24 hours . MAIN RESULTS A statistically significant reduction in postoperative nausea between 8 and 24 hours in patients receiving TDS was noted . CONCLUSIONS Transdermal scopolamine in addition to ondansetron benefits patients at high risk for PONV undergoing outpatient plastic surgery for up to 20 hours after surgery .
|
{
"P": [
"undergoing ambulatory cosmetic surgery .",
"postoperative nausea and vomiting",
"PONV",
"126",
"ASA physical status I and II patients undergoing outpatient plastic surgery",
"three or more risk factors for PONV"
],
"I": [
"Transdermal scopolamine patch",
"ondansetron",
"transdermal scopolamine",
"transdermal scopolamine ( TDS ) patch",
"placebo patch",
"scopolamine"
],
"O": [
"postoperative nausea and vomiting",
"Occurrence of vomiting",
"severity of nausea",
"visual analog scale ( VAS )",
"rescue medication",
"pain intensity",
"pain medications",
"side effects",
"postoperative nausea"
]
}
|
Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in very platinum-sensitive ovarian cancer patients : results from a subset analysis of the CALYPSO phase III trial . AIM To perform a subset analysis of patients with very platinum-sensitive recurrent ovarian cancer ( ROC ) enrolled in the phase III CALYPSO trial . PATIENTS AND METHODS The international non-inferiority trial enrolled women with ROC that relapsed > 6 months following first- or second-line platinum- and paclitaxel-based therapies . Patients were randomised to CD [ carboplatin-pegylated liposomal doxorubicin ( PLD ) ] or CP ( carboplatin-paclitaxel ) and stratified by treatment-free interval ( TFI ) . In this analysis , patients with a TFI > 24 months were analysed separately for progression free survival ( PFS ) , the primary endpoint of CALYPSO , overall survival ( OS ) and safety . RESULTS A total of 259 very platinum-sensitive patients were included ( n=131 , CD ; n=128 , CP ) . Median PFS was 12.0 months for the CD arm and 12.3 months for CP [ HR=1.05 ( 95 % CI , 0.79-1.40 ) ; P=0.73 for superiority ] and median OS was 40.2 months for CD and 43.9 for CP [ HR=1.18 ( 95 % CI 0.85-1.63 ) ; P=0.33 for superiority ] . Overall response rates were 42 % and 38 % , respectively ( P=0.46 ) . Toxicities were more common with CP versus CD , including grade 3/4 neutropenia ( 40.8 % versus 27.5 % ; P=0.025 ) , nausea ( 4.8 % versus 3.1 % ; P=0.47 ) , allergic reaction ( 8 % versus 3.1 % ; P=0.082 ) sensory neuropathy ( 4.8 % versus 2.3 % ; P=0.27 ) and grade 2 alopecia ( 88 % versus 9.2 % ; P < 0.001 ) . Grade 3/4 thrombocytopenia ( 12.2 % versus 3.2 % ; P=0.007 ) and mucositis ( 2.3 % versus 0 % ; P=0.089 ) were more common with CD . Grade 3/4 hand-foot syndrome occurred rarely with CD ( 3 patients versus 0 in CP arm ; P=0.089 ) . CONCLUSION CP and CD were equally effective treatment regimens for patients with very platinum-sensitive ROC . The favourable risk-benefit profile suggests carboplatin-PLD as treatment of choice for these patients .
|
{
"P": [
"very platinum-sensitive ovarian cancer patients :",
"subset analysis of the CALYPSO phase III trial",
"patients with very platinum-sensitive recurrent ovarian cancer ( ROC ) enrolled in the phase III CALYPSO trial .",
"total of 259",
"platinum-sensitive patients were included (",
", CD ;",
", CP )",
"patients with very platinum-sensitive ROC ."
],
"I": [
"Carboplatin and pegylated liposomal doxorubicin",
"carboplatin and paclitaxel",
"platinum- and paclitaxel-based therapies",
"CD [ carboplatin-pegylated liposomal doxorubicin ( PLD ) ]",
"CP ( carboplatin-paclitaxel )",
"CD",
"CP",
"carboplatin-PLD"
],
"O": [
"Median PFS",
"median OS",
"response rates",
"Toxicities",
"grade 3/4 neutropenia",
"nausea",
"allergic reaction",
"sensory neuropathy",
"grade 2 alopecia",
"Grade 3/4 thrombocytopenia",
"mucositis",
"Grade 3/4 hand-foot syndrome"
]
}
|
Direct and indirect effects of interdental hygiene in a clinical trial . Many randomized controlled trials ( RCTs ) in dental research test the efficacy of interventions on more than one outcome variable . Univariate methods , such as the t test or analysis of covariance , can not evaluate the efficacy of interventions on multiple outcomes simultaneously . The aim of this study was to use structural equation modeling ( SEM ) to re-analyze a RCT , comparing the effects of pre-curved interdental brushes and flossing on probing pocket depth ( PPD ) , plaque indices , and bleeding on probing ( BOP ) measured at baseline , intermediate , and final examinations . Results of SEM showed that the observed greater reduction in PPD and BOP in persons using interdental brushing than in those flossing is due mainly to the greater efficiency in plaque removal with the interdental brushes ( indirect effect ) rather than to the compression of the interdental papillae ( direct effect ) . In contrast , smokers showed less BOP at baseline but also less improvement in BOP through direct effects .
|
{
"P": [
"persons using interdental brushing than in those flossing",
"smokers"
],
"I": [
"interdental hygiene",
"structural equation modeling",
"pre-curved interdental brushes and flossing"
],
"O": [
"PPD",
"BOP",
"efficiency in plaque removal"
]
}
|
Caudal analgesia for perianal surgery . A comparison between bupivacaine and diamorphine . Seventy-three patients undergoing elective perianal surgery were randomly divided into a control group , a group who received a caudal injection of 20 ml bupivacaine 0.5 % plain and a group who received diamorphine 2.5 mg in 10 ml normal saline by caudal injection ; a comparison was then made of postoperative analgesia requirements . The bupivacaine group had better analgesia than the control group for the first 8 hours , after which there was no difference . The diamorphine group had better analgesia than the control group for the first 24 hours postoperatively . Side effects were less in the diamorphine group than the control , or the bupivacaine group . In particular , 41 % of the bupivacaine group complained of some degree of urinary retention and one patient required temporary catheterisation . It is concluded that caudal diamorphine gives good postoperative analgesia for perianal operations , particularly when motor blockade is not wanted by the surgeon .
|
{
"P": [
"Seventy-three",
"elective perianal surgery"
],
"I": [
"bupivacaine",
"diamorphine",
"caudal injection"
],
"O": [
"analgesia",
"Side effects",
"some degree of urinary retention",
"temporary catheterisation",
"."
]
}
|
A double-blind comparison of oral ketoprofen 'controlled release ' and indomethacin suppository in the treatment of rheumatoid arthritis with special regard to morning stiffness and pain on awakening . A double-blind , double-dummy , crossover study was carried out in 8 centres to compare the efficacy and tolerability of 'controlled-release ' ketoprofen tablets ( 200 mg ) with that of indomethacin suppositories ( 100 mg ) in out-patients with definite or classical rheumatoid arthritis . Patients were allocated at random to receive a daily bedtime dose of either 1 ketoprofen tablet or 1 indomethacin suppository plus the dummy of the other formulation for a period of 3 weeks . They were then crossed over to the alternative treatment for a further 3 weeks . Daily diary records were kept by patients of the number of night-time awakenings due to pain , pain severity at awakening in the morning and the duration of early morning stiffness . Treatment efficacy was also assessed at the end of each trial period by means of an articular index and by physician 's and patient 's overall evaluation of response . Adverse effects spontaneously mentioned by the patients or elicited by direct questioning using a symptom check-list were recorded . Statistical analysis of the results from 83 evaluable patients showed that the 'controlled-release ' tablet formulation of 200 mg ketoprofen was equally as effective as the 100 mg indomethacin suppository in the treatment of rheumatoid arthritis , especially with regard to pain at awakening and morning stiffness . Side-effects in both groups were those commonly seen with non-steroidal anti-inflammatory drugs and , as expected , gastro-intestinal and CNS disturbances predominated . Overall , side-effects were fewer with ketoprofen than with indomethacin .
|
{
"P": [
"out-patients with definite or classical rheumatoid arthritis ."
],
"I": [
"oral ketoprofen 'controlled release",
"indomethacin suppository",
"'controlled-release ' ketoprofen tablets",
"indomethacin suppositories",
"ketoprofen",
"indomethacin"
],
"O": [
"'controlled-release ' tablet formulation of 200 mg",
"indomethacin suppository",
"pain at awakening and morning stiffness",
"gastro-intestinal and CNS disturbances",
"side-effects",
"ketoprofen",
"indomethacin"
]
}
|
[ Potentiation of the effect of non-depolarizing muscle relaxants by acylaminopenicillins . Studies on the example of vecuronium ] . In a prospective controlled clinical study interactions between nondepolarizing muscle relaxants and acylaminopenicillins were investigated electromyographically . Six patients in each group received either apalcillin , azlocillin , mezlocillin or piperacillin during the operation . Muscle relaxation was maintained using the short acting nondepolarizing relaxant vecuronium , which shows no cumulative effect within clinical dosages . The intra-individual comparison with the control period ( 100 % ) showed a significant prolongation of the duration of action after a fixed dose of vecuronium . The mean increase was +26 % following apalcillin , +46 % after piperacillin , +38 % following mezlocillin and +55 % following azlocillin . The shortest time of the control periods was 8.6 min and the maximum time was 32.6 min . We also found a significant depression of the EMG-response . No significant differences could be detected between the four antibiotics . The method described here has proven to be sensitive enough to detect clinically relevant interactions with muscle relaxants . As a result of our study , caution seems to be necessary if acylaminopenicillins are administered in the early postoperative period .
|
{
"P": [
"Six"
],
"I": [
"acylaminopenicillins",
"nondepolarizing muscle relaxants",
"apalcillin , azlocillin , mezlocillin or piperacillin"
],
"O": [
"Muscle relaxation",
"prolongation of the duration of action",
"mean increase",
"shortest time",
"depression",
"EMG-response",
"clinically relevant interactions",
"muscle relaxants"
]
}
|
Virtual reality intervention for older women with breast cancer . This study examined the effects of a virtual reality distraction intervention on chemotherapy-related symptom distress levels in 16 women aged 50 and older . A cross-over design was used to answer the following research questions : ( 1 ) Is virtual reality an effective distraction intervention for reducing chemotherapy-related symptom distress levels in older women with breast cancer ? ( 2 ) Does virtual reality have a lasting effect ? Chemotherapy treatments are intensive and difficult to endure . One way to cope with chemotherapy-related symptom distress is through the use of distraction . For this study , a head-mounted display ( Sony PC Glasstron PLM - S700 ) was used to display encompassing images and block competing stimuli during chemotherapy infusions . The Symptom Distress Scale ( SDS ) , Revised Piper Fatigue Scale ( PFS ) , and the State Anxiety Inventory ( SAI ) were used to measure symptom distress . For two matched chemotherapy treatments , one pre-test and two post-test measures were employed . Participants were randomly assigned to receive the VR distraction intervention during one chemotherapy treatment and received no distraction intervention ( control condition ) during an alternate chemotherapy treatment . Analysis using paired t-tests demonstrated a significant decrease in the SAI ( p = 0.10 ) scores immediately following chemotherapy treatments when participants used VR . No significant changes were found in SDS or PFS values . There was a consistent trend toward improved symptoms on all measures 48 h following completion of chemotherapy . Evaluation of the intervention indicated that women thought the head mounted device was easy to use , they experienced no cybersickness , and 100 % would use VR again .
|
{
"P": [
"older",
"women",
"breast cancer",
"16",
"50 and older"
],
"I": [
"Virtual reality intervention",
"virtual reality distraction intervention",
"virtual reality",
"a head-mounted display ( Sony PC Glasstron PLM - S700 ) was used to display encompassing images and block competing stimuli during chemotherapy infusions .",
"VR distraction intervention during one chemotherapy treatment",
"no distraction intervention ( control condition )"
],
"O": [
"symptom distress",
"Symptom Distress Scale ( SDS )",
"Revised Piper Fatigue Scale ( PFS ) ,",
"State Anxiety Inventory ( SAI",
"decrease",
"SAI",
"SDS",
"PFS",
"improved symptoms",
"cybersickness"
]
}
|
Montelukast treatment of moderate to severe atopic dermatitis in adults : a randomized , double-blind , placebo-controlled trial . In a randomized , double-blind , placebo-controlled 4-week trial , 59 patients with moderate to severe atopic dermatitis were treated orally with 10 mg of the leukotriene antagonist montelukast . Forty-seven patients completed the study . No difference in efficacy was seen among patients who received montelukast and the group given a placebo .
|
{
"P": [
"severe atopic dermatitis in adults :"
],
"I": [
"Montelukast treatment",
"placebo-controlled",
"leukotriene antagonist montelukast",
"montelukast",
"placebo"
],
"O": [
"No difference in efficacy"
]
}
|
A comparative study of ofloxacin and cefixime for treatment of typhoid fever in children . The Dong Nai Pediatric Center Typhoid Study Group . BACKGROUND Despite concerns about safety in children , fluoroquinolone antibiotics have become the treatment of choice in patients with multidrug-resistant typhoid fever in Vietnam . However , quinolone-resistant strains of Salmonella typhi have recently been reported from Vietnam ; and if quinolone resistance becomes established , alternative oral treatment options will be needed . OBJECTIVE Cefixime , an orally administered third generation cephalosporin , was compared with ofloxacin for the treatment of uncomplicated typhoid fever in children . METHODS In an open trial children with suspected typhoid fever were randomized to receive either ofloxacin ( 10 mg/kg/day in two divided doses ) for 5 days or cefixime ( 20 mg/kg/day in two divided doses ) for 7 days . RESULTS S. typhi was isolated from 82 patients ( 44 in the cefixime group , 38 in the ofloxacin group ) and 70 ( 85 % ) of the isolates were multidrug-resistant . Median ( 95 % confidence interval , range ) fever clearance times were 4.4 ( 4 to 5.2 , 0.2 to 9.9 ) days for ofloxacin recipients and 8.5 ( 4.2 to 9 , 1.8 to 15.2 ) days for cefixime-treated patients ( P < 0.0001 ) . There were 11 treatment failures ( 10 acute and one relapse ) in the cefixime group and 1 acute treatment failure in the ofloxacin group ( mean difference , 22 % ; 95 % confidence interval , 9 to 36 % ) . CONCLUSION Short course treatment with cefixime may provide a useful alternative treatment in cases of uncomplicated typhoid fever in children , but it is less effective than short course treatment with ofloxacin .
|
{
"P": [
"typhoid fever",
"children",
"multidrug-resistant typhoid fever",
"82",
"70",
"uncomplicated typhoid fever"
],
"I": [
"ofloxacin",
"cefixime",
"fluoroquinolone antibiotics",
"Cefixime",
"cephalosporin",
"cefixime-treated"
],
"O": [
"fever clearance times",
"treatment failures",
"acute treatment failure"
]
}
|
Topical treatment of tinea pedis using 6 % coriander oil in unguentum leniens : a randomized , controlled , comparative pilot study . BACKGROUND The antifungal activity of coriander oil has already been demonstrated in vitro . OBJECTIVE Evaluation of the efficacy and tolerability of 6 % coriander oil in unguentum leniens in the treatment of interdigital tinea pedis . METHODS Half-side comparative pilot study on subjects with symmetric , bilateral interdigital tinea pedis . Active drug and placebo control were applied twice daily on the affected areas , and follow-up visits were performed on days 14 and 28 . RESULTS 40 participants ( mean age 52.5 years , 60 % male ) were included in the study . For 6 % coriander oil in unguentum leniens , a highly significant improvement of the clinical signs ( p < 0.0001 ) was observed during the entire observation period ; the number of positive fungal cultures also tended to decrease ( p = 0.0654 ) . The tolerability of the tested substances was good . CONCLUSION Coriander oil is effective and well tolerated in the treatment of interdigital tinea pedis .
|
{
"P": [],
"I": [
"coriander oil",
"6 % coriander oil",
"placebo",
"Coriander oil"
],
"O": [
"efficacy",
"tolerability",
"clinical signs",
"number of positive fungal cultures"
]
}
|
Randomised Phase I/II trial assessing the safety and efficacy of radiolabelled anti-carcinoembryonic antigen I ( 131 ) KAb201 antibodies given intra-arterially or intravenously in patients with unresectable pancreatic adenocarcinoma . BACKGROUND Advanced pancreatic cancer has a poor prognosis , and the current standard of care ( gemcitabine based chemotherapy ) provides a small survival advantage . However the drawback is the accompanying systemic toxicity , which targeted treatments may overcome . This study aimed to evaluate the safety and tolerability of KAb201 , an anti-carcinoembryonic antigen monoclonal antibody , labelled with I ( 131 ) in pancreatic cancer ( ISRCTN 16857581 ) . METHODS Patients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were randomised to receive KAb 201 via either the intra-arterial or intravenous delivery route . The dose limiting toxicities within each group were determined . Patients were assessed for safety and efficacy and followed up until death . RESULTS Between February 2003 and July 2005 , 25 patients were enrolled . Nineteen patients were randomised , 9 to the intravenous and 10 to the intra-arterial arms . In the intra-arterial arm , dose limiting toxicity was seen in 2/6 ( 33 % ) patients at 50 mCi whereas in the intravenous arm , dose limiting toxicity was noted in 1/6 patients at 50 mCi , but did not occur at 75 mCi ( 0/3 ) .The overall response rate was 6 % ( 1/18 ) . Median overall survival was 5.2 months ( 95 % confidence interval = 3.3 to 9 months ) , with no significant difference between the intravenous and intra-arterial arms ( log rank test p = 0.79 ) . One patient was still alive at the time of this analysis . CONCLUSION Dose limiting toxicity for KAb201 with I ( 131 ) by the intra-arterial route was 50 mCi , while dose limiting toxicity was not reached in the intravenous arm .
|
{
"P": [
"patients with unresectable pancreatic adenocarcinoma .",
"Advanced pancreatic cancer",
"Patients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were randomised to receive KAb 201",
"Between February 2003 and July 2005 , 25 patients were enrolled . Nineteen patients were randomised , 9 to the intravenous and 10 to the intra-arterial arms ."
],
"I": [
"radiolabelled anti-carcinoembryonic antigen I ( 131 ) KAb201",
"gemcitabine based chemotherapy",
"KAb201",
"KAb 201"
],
"O": [
"safety",
"efficacy",
"tolerability",
"dose limiting toxicities",
"safety and efficacy",
"toxicity",
"response rate",
"Median overall survival",
"Dose limiting toxicity",
"dose limiting toxicity"
]
}
|
Multiple risk factor intervention reduces cardiovascular risk in hypertensive patients with echolucent plaques in the carotid artery . OBJECTIVE In a previously published randomized 6-year study we observed that multiple risk factor intervention reduced cardiovascular risk in high-risk hypertensive men , and that this effect was confined to patients with carotid artery plaques . Hypothetically , the underlying mechanism might have been a stabilization of echolucent , instable , rupture-prone plaques . The aim of the present study was to examine plaque characteristics by B-mode ultrasound in the previous intervention study , and also to investigate the relationship between plaque characteristics at baseline and cardiovascular events during the 6-year follow-up in the two randomization groups . METHODS High resolution B-mode ultrasound was used to characterize plaque echogenicity in four subgroups - dominantly echolucent , substantially echolucent , dominantly echogenic , and uniformly echogenic . RESULTS In the usual care group 17 of 32 ( 53 % ) patients with echolucent plaques at baseline suffered from a combined end-point ( any death or nonfatal myocardial infarction or nonfatal stroke ) during follow-up compared with seven of 28 ( 25 % ) patients in the intervention group ( P = 0.036 ) . The corresponding numbers in patients with echogenic plaques were n = 4/13 ( 31 % ) and n = 4/17 ( 24 % ) , respectively ( NS ) . In the usual care group 11 of 33 ( 33 % ) patients with no plaques suffered from a combined end-point during follow-up compared with 11 of 30 ( 37 % ) in the intervention group . CONCLUSION Our data indicate that the beneficial effect of the multiple risk intervention programme was confined to those patients with echolucent plaques . The data have to be confirmed with a large-scale trial .
|
{
"P": [
"high-risk hypertensive men"
],
"I": [
"Multiple risk factor intervention",
"B-mode ultrasound",
"High resolution B-mode ultrasound",
"usual care group",
"intervention group",
"multiple risk intervention programme"
],
"O": [
"plaque characteristics",
"cardiovascular events",
"characterize plaque echogenicity",
"echolucent plaques",
"death",
"nonfatal myocardial infarction or nonfatal stroke",
"echogenic plaques",
"beneficial effect"
]
}
|
REVIVE Trial : Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure . UNLABELLED Cell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy . Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure ( IHF ) or nonischemic heart failure ( NIHF ) . This was a prospective randomized , multicenter , open-label study of the safety and feasibility of bone marrow aspirate concentrate ( BMAC ) infused retrograde into the coronary sinus . Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control ( standard heart failure care ) in a 4:1 ratio . Accordingly , 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group . Similarly , 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group . All 60 patients were successfully enrolled in the study . The treatment groups received BMAC infusion without complications . The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline , from 25.1 % at screening to 31.1 % at 12 months ( p=.007 ) in the NIHF group and from 26.3 % to 31.1 % in the IHF group ( p=.035 ) . The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm ( p=.020 ) . Retrograde BMAC delivery is safe . All patients receiving BMAC experienced improvements in left ventricular ejection fraction , but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide . These results provide the basis for a larger clinical trial in HF patients . SIGNIFICANCE This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure . This was a multinational , multicenter study , and it is novel , translatable , and scalable . On the basis of this trial and the safety of retrograde coronary sinus infusion , there are three other trials under way using this route of delivery .
|
{
"P": [],
"I": [
"Cell therapy",
"bone marrow aspirate concentrate",
"retrograde",
"BMAC infusion",
"control",
"BMAC"
],
"O": [
"left ventricular ejection fraction",
"significant improvement",
"end-systolic diameter decreased significantly",
"delivery is safe .",
"left ventricular end-systolic diameter and B-type natriuretic peptide ."
]
}
|
Effects of weight reduction interventions by community pharmacists . OBJECTIVE To compare a meal replacement ( MR ) program with a conventional reduced-calorie diet ( RCD ) for weight management using the pharmacy as the setting and the pharmacist as the point of contact for dietary advice . DESIGN Randomized , controlled , open-label trial . SETTING Travis Pharmacy in Shenandoah , Iowa . PATIENTS Ninety-five patients from southwestern iowa and southeastern Nebraska were enrolled , of whom 88 were considered eligible for comparison ( by continuing through week 2 of the study ) . INTERVENTION Patients were randomized to an MR plan or a traditional RCD plan . Patients were followed for a 3-month period of active weight loss and a 10-week period of weight maintenance . Patients returned every 3 weeks for follow-up with the pharmacist , for a total of 13 visits . MAIN OUTCOME MEASURE Weight changes . RESULTS During the active weight loss phase , the MR ( n = 45 ) and RCD ( n = 43 ) groups lost a significant amount of weight , although no significant difference was found between the groups ( mean +/- standard error = 4.90 +/- 0.30 kg MR versus 4.30 +/- 0.30 kg RCD ; P = .16 ) . In the weight maintenance phase , the MR group lost 0.70 +/- 0.40 kg and the RCD group lost 0.90 +/- 0.40 kg ( P = .60 ) . Significant improvements were observed in waist circumference , systolic and diastolic blood pressure , and triglyceride levels . No significant changes were seen in high-density lipoprotein cholesterol or low-density lipoprotein cholesterol levels in either group . CONCLUSION Successful weight management can be achieved in a pharmacy setting . Both MR and RCD programs were effective .
|
{
"P": [
"Ninety-five",
"88"
],
"I": [
"weight reduction interventions",
"meal replacement ( MR ) program",
"conventional reduced-calorie diet ( RCD )",
"dietary advice",
"MR",
"RCD"
],
"O": [
"Weight changes .",
"significant amount of weight",
"waist circumference , systolic and diastolic blood pressure , and triglyceride levels .",
"high-density lipoprotein cholesterol or low-density lipoprotein cholesterol levels"
]
}
|
Prediction of metabolic and cardiopulmonary responses to maximum cycle ergometry : a randomised study . All of the most widely-cited studies for the prediction of maximum exercise responses have utilized either volunteers or referred subjects . Therefore , selection bias , with overestimation of the reference values , is a likely consequence . In order to establish a set of predictive equations for the gas exchange , ventilatory and cardiovascular responses to maximum ramp-incremental cycle ergometry , this study prospectively evaluated 120 sedentary individuals ( 60 males , 60 females , aged 20-80 ) , randomly-selected from > 8,000 subjects . Regular physical activity pattern by questionnaire , body composition by anthropometry and dual energy X-ray absorptiometry ( n = 75 ) and knee strength by isokinetic dynamometry were also assessed . Previously reported equations typically overestimated the subjects ' peak oxygen uptake ( p < 0.05 ) . Prediction linear equations for the main variables of clinical interest were established by backward stepwise regression analysis including : sex , age , knee extensor peak torque , bone-free lean leg mass , total and lean body mass , height , and physical activity scores . Reference intervals ( 95 % confidence limits ) were calculated : some of these values differed markedly from those formerly recommended . The results therefore might provide a more appropriate frame of reference for interpretation of the responses to symptom-limited ramp incremental cycle ergometry in sedentary subjects ; i.e . those usually referred for clinical cardiopulmonary exercise tests .
|
{
"P": [
"either volunteers or referred subjects",
"120",
"sedentary individuals",
"60",
"males",
"females",
"aged 20-80",
"randomly-selected from > 8,000 subjects"
],
"I": [
"maximum cycle ergometry",
"maximum ramp-incremental cycle ergometry",
"dual energy X-ray absorptiometry",
"ramp incremental cycle ergometry"
],
"O": [
"maximum exercise responses",
"gas exchange , ventilatory and cardiovascular responses",
"physical activity pattern by questionnaire , body composition by anthropometry and dual energy X-ray absorptiometry ( n = 75 ) and knee strength by isokinetic dynamometry",
"peak oxygen uptake",
"Reference intervals",
"responses to symptom-limited ramp incremental cycle ergometry"
]
}
|
Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation : a randomized trial . To evaluate the effect of the different doses of antithymocyte globulin ( ATG ) on the incidence of acute GVHD among patients receiving hematopoietic SCT without ex vivo T-cell-depletion from haploidentical donors , 224 patients with standard-risk hematological malignancy were randomized in this study . One hundred and twelve patients received 6 mg/kg ATG , whereas the remaining patients received 10 mg/kg ATG . This study was registered at http : //www.chictr.org as No . ChiCTR-TRC-11001761 . The incidence of grade III-IV acute GVHD was higher in the ATG-6 group ( 16.1 % , 95 % confidence interval ( CI ) , 9.1-23.1 % ) than in the ATG-10 group ( 4.5 % , CI , 0.7-8.3 % , P=0.005 , 95 % CI for the difference , -19.4 % to -3.8 % ) . EBV reactivation occurred more frequently in the ATG-10 group ( 25.3 % , 17.1-33.5 % ) than in the ATG-6 group ( 9.6 % ( 4.0-15.2 % ) , P=0.001 ) . The 1-year disease-free survival rates were 84.3 % ( 77.3-91.3 % ) and 86.0 % ( 79.2-92.8 % ) for the ATG-6 group and ATG-10 groups , respectively ( P=0.88 ) . In conclusion , although 6 mg/kg ATG applied in haploidentical transplantation decreased the risk of EBV reactivation compared with 10 mg/kg ATG , this treatment exposes patients to a higher risk for severe acute GVHD .
|
{
"P": [
"standard-risk disease",
"haploidentical transplantation",
"224 patients",
"standard-risk hematological malignancy",
"One hundred and twelve patients"
],
"I": [
"antithymocyte globulin",
"antithymocyte globulin ( ATG )"
],
"O": []
}
|
Step-down approach using either cyclosporin A or methotrexate as maintenance therapy in early rheumatoid arthritis . OBJECTIVE To evaluate the feasibility and outcome of the step-down approach using either cyclosporin A ( CSA ) or methotrexate ( MTX ) as maintenance therapy following 6 months treatment with these 2 agents in combination in early , nonerosive rheumatoid arthritis ( RA ) . METHODS Fifty-seven patients younger than 65 years with early , nonerosive RA were first treated with CSA and MTX in combination for 6 months . They were then randomly stepped down to single-agent maintenance treatment for another 18 months . Safety , clinical efficacy , survival on treatment , and radiographic progression were evaluated . RESULTS When being treated with combination therapy , 7 of the 57 patients ( 12.3 % ) withdrew because of adverse events . Of the remaining 50 patients , 42 ( 84.0 % ) were American College of Rheumatology ( ACR ) 20 % responders , 30 ( 60.0 % ) were ACR 50 % responders , and 23 ( 46.0 % ) were ACR 70 % responders . At month 6 , 22 patients were randomized to CSA and 27 to MTX . During this trial period , the treatment was discontinued by 16 patients taking CSA ( mainly because of loss of efficacy ) and by 4 taking MTX . At month 24 , the probability ( +/- SEM ) of survival on treatment was 0.273 +/- 0.09 for CSA and 0.852 +/- 0.07 for MTX . Of the 6 CSA patients who completed the trial , 4 ( 66.7 % ) were ACR 20 % responders , and 3 ( 50 % ) were both ACR 50 % and ACR 70 % responders . Of the 23 completers in the MTX arm , 21 ( 91.3 % ) were ACR 20 % responders , 18 ( 78.3 % ) were ACR 50 % , and 10 ( 43.5 % ) were ACR 70 % responders . The treatment was not responsible for severe adverse events . Radiography showed a slow progression in the damage score and number of eroded joints in both treatment groups . CONCLUSION Stepping down to single agent maintenance therapy following 6 months of combination treatment with CSA and MTX in early RA was only successful with MTX . Because this treatment did not prevent some radiographic progression , other approaches ( e.g. , step-up approach ) may be more appropriate in early RA .
|
{
"P": [
"rheumatoid arthritis .",
"nonerosive RA",
"7 of the 57 patients",
"early RA"
],
"I": [
"cyclosporin A",
"methotrexate",
"cyclosporin A ( CSA )",
"methotrexate ( MTX )",
"CSA",
"MTX in combination",
"single-agent",
"MTX"
],
"O": [
"feasibility and outcome",
"Safety , clinical efficacy",
"survival on treatment",
"radiographic progression",
"adverse events",
"efficacy",
"survival",
"damage score and number of eroded joints"
]
}
|
Early reperfusion and late clinical outcomes in patients presenting with acute myocardial infarction randomly assigned to primary percutaneous coronary intervention or streptokinase . BACKGROUND Primary percutaneous coronary intervention ( PCI ) has become an alternative to thrombolytic therapy as a reperfusion strategy for ST-elevation acute myocardial infarction ( AMI ) . METHODS The main goal of this study was to determine whether PCI and thrombolytic therapy achieve comparable reperfusion rates , as evidenced by ST-segment resolution . Secondary end points included infarct vessel patency rates before hospital discharge and short- and long-term outcomes . Patients with ischemic chest pain with duration < or =12 hours and no contraindication for thrombolytic therapy were included . RESULTS Between October 1993 and August 1995 , 58 patients were randomly assigned to streptokinase ( SK ) and 54 patients to primary PCI . Baseline clinical characteristics and infarct location were well balanced in both groups . Median age ( interquartile range ) was 68 ( 58 , 75 ) years , 29 % were women , and 78 % of the patients met at least one criterion for " not low risk " AMI ( anterior location , age > 70 years old , previous MI , systolic blood pressure < 100 mm Hg , and/or heart rate > 100 bpm ) . The median time from symptom onset to random assignment was 217 ( 139 , 335 ) minutes in the PCI group and 210 ( 145 , 334 ) minutes in the SK group . Median random assignment to balloon time was 82 ( 55 , 100 ) minutes , and median random assignment to needle time was 15 ( 10 , 26 ) minutes ( P < .0001 ) . TIMI grade 3 flow after primary PCI was obtained in 85 % of patients . The proportion of patients with ST-segment resolution > or =50 % at 120 minutes was 80 % in the PCI group and 50 % in the SK group ( P =.001 ) . The predischarge angiogram showed the presence of TIMI 3 flow in 96 % of patients who received PCI and 65 % of patients who received SK ( P < .001 ) . A composite of in-hospital death , reinfarction , severe heart failure , stroke , and major bleeding occurred in 15 % of patients who received PCI and 21 % of patients who received SK ( P =.4 ) . At 3 years , freedom from the composite end point of AMI , postdischarge revascularization , and death was 61 % in the PCI group and 40 % in the SK group ( P =.025 ) . CONCLUSIONS Our study shows that primary PCI , as compared with SK , is associated with more effective ST-segment resolution , higher patency rates in the infarct vessel at 7 days , and more favorable clinical outcomes at 3 years of follow-up .
|
{
"P": [
"patients presenting with acute myocardial infarction",
"ST-elevation acute myocardial infarction ( AMI ) .",
"ischemic chest pain",
"58",
"54",
"68",
"women",
"> 70 years"
],
"I": [
"primary percutaneous coronary intervention",
"streptokinase",
"Primary percutaneous coronary intervention ( PCI )",
"thrombolytic therapy",
"PCI",
"streptokinase ( SK )",
"primary PCI",
"SK"
],
"O": [
"infarct vessel patency rates",
"blood pressure",
"median time from symptom onset",
"balloon time",
"needle time",
"TIMI grade 3 flow",
"ST-segment resolution",
"presence of TIMI 3 flow",
"in-hospital death",
"reinfarction",
"severe heart failure",
"stroke",
"major bleeding",
"composite end point of AMI",
"postdischarge revascularization",
"patency rates"
]
}
|
Mortality in patients with small choroidal melanoma . COMS report no . 4 . The Collaborative Ocular Melanoma Study Group . OBJECTIVE To describe the clinical characteristics and survival experience of a prospectively followed up group of patients with small choroidal melanoma . METHODS The Collaborative Ocular Melanoma Study ( COMS ) is a set of clinical trials designed to compare the role of radiotherapy and enucleation in the treatment of medium and large-size choroidal melanoma . From December 1986 to August 1989 , patients with small choroidal melanoma , not large enough to be eligible for the COMS clinical trials , were offered participation in a nonrandomized prospective follow-up study . Small choroidal melanomas were defined as 1.0 to 3.0 mm in apical height and at least 5.0 mm in basal diameter . A total of 204 patients were enrolled in the study . Patients were followed up annually through August 1989 . Two additional assessments of treatment status and mortality were conducted in 1993-1994 and 1995-1996 . The median length of follow-up was 92 months . Eight percent of patients were treated at the time of study enrollment and an additional 33 % were treated during follow-up . RESULTS Twenty-seven patients have died ; 6 deaths were reported by the clinical center as due to metastatic melanoma . The Kaplan-Meier estimate of 5-year all-cause mortality was 6.0 % ( 95 % confidence interval , 2.7 % -9.3 % ) and 8-year all-cause mortality was 14.9 % ( 95 % confidence interval , 9.6 % -20.2 % ) . CONCLUSIONS Otherwise healthy patients , average age of 60 years , without a previous diagnosis of malignant disease who have small choroidal lesions judged to be melanoma have a low risk of dying within 5 years .
|
{
"P": [],
"I": [
"radiotherapy",
"enucleation"
],
"O": [
"Mortality",
"mortality",
"median length",
"died",
"deaths",
"metastatic melanoma",
"choroidal lesions"
]
}
|
Comparative effects of pinacidil and nifedipine in the treatment of arterial hypertension .
|
{
"P": [
"arterial hypertension ."
],
"I": [
"pinacidil",
"nifedipine"
],
"O": []
}
|
A comparison between the effect of oxytocin only and oxytocin plus propranolol on the labor ( a double blind randomized trial ) . OBJECTIVE The comparison between the effect of oxytocin alone or in combination with propranolol on labor . METHODS A double blind randomized controlled trial was performed on 150 nulliparas with a gestational age of 39-41 weeks of pregnancy and a Bishop score of < or =5 . In the first group ( oxytocin group = 75 ) , oxytocin alone was used for induction of labor . In the second group ( propranolol group = 75 cases ) , before the beginning of oxytocin , 2 mg propranolol was slowly injected intravenously then the oxytocin was initiated . RESULTS The number of patients who delivered in the first day showed no difference between the two groups . The mean duration for obtaining good contractions was shorter in the propranolol group in both the first and second day of induction The mean interval between the beginning of induction until the beginning of active phase at the first day of induction was shorter in the propranolol group . The mean interval between the beginning of induction until delivery at the first day of induction was shorter in the propranolol group . The amount of necessary oxytocin for the first day of induction was less in the propranolol group . CONCLUSION Propranolol may shorten the induction duration and labor and reduce the amount of necessary oxytocin .
|
{
"P": [
"150",
"nulliparas",
"pregnancy",
"Bishop score of < or =5"
],
"I": [
"oxytocin only",
"oxytocin plus propranolol",
"oxytocin alone",
"in combination with propranolol",
"oxytocin",
"( propranolol",
"propranolol",
"Propranolol"
],
"O": [
"labor",
"labor .",
"induction of labor .",
"number of patients who delivered in the first day",
"duration for obtaining good contractions",
"mean interval between the beginning of induction until delivery at the first day of induction",
"amount of necessary oxytocin",
"induction duration and labor"
]
}
|
Development of a telehealth intervention for head and neck cancer patients . Treatment for head and neck cancer precipitates a myriad of distressing symptoms . Patients may be isolated both physically and socially and may lack the self-efficacy to report problems and participate as partners in their care . The goal of this project was to design a telehealth intervention to address such isolation , develop patient self-efficacy , and improve symptom management during the treatment experience . Participatory action research and a review of the literature were used to develop electronically administered symptom management algorithms addressing all major symptoms experienced by patients undergoing treatment for head and neck cancers . Daily questions and related messages were then programmed into an easy-to-use telehealth messaging device , the Health Buddy ( R ) . Clinician and patient acceptance , feasibility , and technology issues were measured . Using participatory action research is an effective means for developing electronic algorithms acceptable to both clinicians and patients . The use of a simple tele-messaging device as an adjunct to symptom management is feasible , affordable , and acceptable to patients . This telehealth intervention provides support and education to patients undergoing treatment for head and neck cancers .
|
{
"P": [
"head and neck cancer",
"head and neck cancers"
],
"I": [
"telehealth intervention",
"Health Buddy ( R )"
],
"O": [
"Clinician and patient acceptance",
"feasibility",
"technology issues",
"feasible",
"affordable",
"acceptable"
]
}
|
Cardiovascular and behavioral effects of aerobic exercise training in healthy older men and women . The cardiovascular and behavioral adaptations associated with a 4-month program of aerobic exercise training were examined in 101 older men and women ( mean age = 67 years ) . Subjects were randomly assigned to an Aerobic Exercise group , a Yoga and Flexibility control group , or a Waiting List control group . Prior to and following the 4-month program , subjects underwent comprehensive physiological and psychological evaluations . Physiological measures included measurement of blood pressure , lipids , bone density , and cardiorespiratory fitness including direct measurements of peak oxygen consumption ( VO2 ) and anaerobic threshold . Psychological measures included measures of mood , psychiatric symptoms , and neuropsychological functioning . This study demonstrated that 4 months of aerobic exercise training produced an overall 11.6 % improvement in peak VO2 and a 13 % increase in anaerobic threshold . In contrast , the Yoga and Waiting List control groups experienced no change in cardiorespiratory fitness . Other favorable physiological changes observed among aerobic exercise participants included lower cholesterol levels , diastolic blood pressure levels , and for subjects at risk for bone fracture , a trend toward an increase in bone mineral content . Although few significant psychological changes could be attributed to aerobic exercise training , participants in the two active treatment groups perceived themselves as improving on a number of psychological and behavioral dimensions .
|
{
"P": [
"older",
"men and women",
"101"
],
"I": [
"aerobic exercise",
"aerobic exercise training",
"Aerobic Exercise",
"group",
"Yoga",
"and",
"Flexibility control",
"Waiting List control group",
"Waiting List"
],
"O": [
"Physiological measures included measurement of blood pressure , lipids , bone density , and cardiorespiratory fitness including direct measurements of peak oxygen consumption ( VO2 ) and anaerobic threshold .",
"Psychological measures included measures of mood , psychiatric symptoms , and neuropsychological functioning ."
]
}
|
Intravenous lipid emulsion improves recovery time and quality from isoflurane anaesthesia : a double-blind clinical trial . Recovery time and quality after general anaesthesia is important for patient safety . This study aimed to determine whether intravenous lipid emulsion could improve recovery profiles from isoflurane anaesthesia in adult patients undergoing laparoscopic cholecystectomy . Sixty-six patients were enrolled . After anaesthesia induction , inspired isoflurane concentration was adjusted to maintain stable vital signs and the suitable conditions for operation . At the end of the operation , the isoflurane was discontinued , and either 2 ml/kg 30 % lipid emulsions or 0.9 % saline solution was administered intravenously . The time to eye opening , extubation and exit from the operation room was recorded , and the quality of recovery from anaesthesia was assessed . Sixty patients completed the study . The median time to eye opening and exit from the operation room was significantly shorter in the lipid emulsion group than in the saline group [ 15.5 ( interquartile range 9.0 ) versus 20.0 ( 10.0 ) min. , p = 0.01 ; 19.5 ( 8.3 ) versus 23.6 ( 6.3 ) min. , p = 0.04 , respectively ] , whereas the median time to extubation did not show any noticeable difference . The quality of recovery was better in the lipid emulsion group than that of the saline solution group with respect to drowsiness visual analogue scale score ( p < 0.01 ) , Observer 's Assessment of Alertness/Sedation score ( p < 0.01 ) , Mini-Mental State Examination score ( p = 0.04 ) and Modified Aldrete Post Anaesthesia Recovery score ( p = 0.03 ) . No serious adverse events were observed during the study period . In conclusion , intravenous lipid emulsion may effectively improve the recovery time and quality from isoflurane anaesthesia for laparoscopic cholecystectomy .
|
{
"P": [
"adult",
"laparoscopic cholecystectomy",
"Sixty-six",
"Sixty patients"
],
"I": [
"Intravenous lipid emulsion",
"isoflurane anaesthesia :",
"intravenous lipid emulsion",
"isoflurane anaesthesia",
"isoflurane",
"lipid emulsions",
"saline solution",
"lipid emulsion"
],
"O": []
}
|
[ Postlaparoscopic pain syndrome . Results of a prospective , randomized study ] . The so-called post-laparoscopic algesia is a specific impairment of about 63 % of the patients who undergo laparoscopic surgical operations . This impairment takes the form of mild to moderate shoulder pain . Eliminating the causes of pain has a clear advantage over symptomatic treatment using analgetics , a fact worth a good consideration especially with the post-operative sojourn at the hospital becoming shorter and shorter . In a prospective controlled study , involving 42 patients subdivided into four groups namely , higher or lower insufflation pressures , chemically inert insufflation gas and control groups ; the use of analgetics , lung function , operation duration , amount of insufflated gas , intraperitoneal pH-values and post-operative complications in the various subgroups were compared to each other with regard to post-operative pain perception . The results did not show any significant differences among the groups regarding the main parameters like pH-value or different insufflation pressures etc . These results led to the termination of the study based on the raised criteria since we anticipated the actual cause of the shoulder pain to be due to an unknown factor . By the evaluation of the individual data , it became apparent that , the pains increase with increasing gas consumption , a fact which led to assumption that the pains are caused by a physical effect such as the cooling of the peritoneum .
|
{
"P": [
"laparoscopic surgical operations",
"42"
],
"I": [
"laparoscopic surgical operations",
"higher or lower insufflation pressures",
"chemically inert insufflation gas",
"control"
],
"O": [
"analgetics",
"lung function",
"operation duration",
"amount of insufflated gas",
"intraperitoneal pH-values",
"post-operative complications",
"pH-value or different insufflation pressures",
"pains increase",
"pains"
]
}
|
Motion aftereffects with horizontally moving sound sources in the free field . A horizontally moving sound was presented to an observer seated in the center of an anechoic chamber . The sound , either a 500-Hz low-pass noise or a 6300-Hz high-pass noise , repeatedly traversed a semicircular arc in the observer 's front hemifield at ear level ( distance : 1.5 m ) . At 10-sec intervals this adaptor was interrupted , and a 750-msec moving probe ( a 500-Hz low-pass noise ) was presented from a horizontal arc 1.6 m in front of the observer . During a run , the adaptor was presented at a constant velocity ( -200 degrees to +200 degrees/sec ) , while probes with velocities varying from -10 degrees to +10 degrees/sec were presented in a random order . Observers judged the direction of motion ( left or right ) of each probe . As in the case of stimuli presented over headphones ( Grantham & Wightman , 1979 ) , an auditory motion aftereffect ( MAE ) occurred : subjects responded " left " to probes more often when the adaptor moved right than when it moved left . When the adaptor and probe were spectrally the same , the MAE was greater than when they were from different spectral regions ; the magnitude of this difference depended on adaptor speed and was subject-dependent . It is proposed that there are two components underlying the auditory MAE : ( 1 ) a generalized bias to respond that probes move in the direction opposite to that of the adaptor , independent of their spectra ; and ( 2 ) a loss of sensitivity to the velocity of moving sounds after prolonged exposure to moving sounds having the same spectral content .
|
{
"P": [],
"I": [
"horizontally moving sound",
"500-Hz low-pass noise",
"6300-Hz high-pass noise",
"moving probe"
],
"O": [
"auditory motion aftereffect ( MAE )",
"MAE"
]
}
|
Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma ( LUX-Lung 3 and LUX-Lung 6 ) : analysis of overall survival data from two randomised , phase 3 trials . BACKGROUND We aimed to assess the effect of afatinib on overall survival of patients with EGFR mutation-positive lung adenocarcinoma through an analysis of data from two open-label , randomised , phase 3 trials . METHODS Previously untreated patients with EGFR mutation-positive stage IIIB or IV lung adenocarcinoma were enrolled in LUX-Lung 3 ( n=345 ) and LUX-Lung 6 ( n=364 ) . These patients were randomly assigned in a 2:1 ratio to receive afatinib or chemotherapy ( pemetrexed-cisplatin [ LUX-Lung 3 ] or gemcitabine-cisplatin [ LUX-Lung 6 ] ) , stratified by EGFR mutation ( exon 19 deletion [ del19 ] , Leu858Arg , or other ) and ethnic origin ( LUX-Lung 3 only ) . We planned analyses of mature overall survival data in the intention-to-treat population after 209 ( LUX-Lung 3 ) and 237 ( LUX-Lung 6 ) deaths . These ongoing studies are registered with ClinicalTrials.gov , numbers NCT00949650 and NCT01121393 . FINDINGS Median follow-up in LUX-Lung 3 was 41 months ( IQR 35-44 ) ; 213 ( 62 % ) of 345 patients had died . Median follow-up in LUX-Lung 6 was 33 months ( IQR 31-37 ) ; 246 ( 68 % ) of 364 patients had died . In LUX-Lung 3 , median overall survival was 28.2 months ( 95 % CI 24.6-33.6 ) in the afatinib group and 28.2 months ( 20.7-33.2 ) in the pemetrexed-cisplatin group ( HR 0.88 , 95 % CI 0.66-1.17 , p=0.39 ) . In LUX-Lung 6 , median overall survival was 23.1 months ( 95 % CI 20.4-27.3 ) in the afatinib group and 23.5 months ( 18.0-25.6 ) in the gemcitabine-cisplatin group ( HR 0.93 , 95 % CI 0.72-1.22 , p=0.61 ) . However , in preplanned analyses , overall survival was significantly longer for patients with del19-positive tumours in the afatinib group than in the chemotherapy group in both trials : in LUX-Lung 3 , median overall survival was 33.3 months ( 95 % CI 26.8-41.5 ) in the afatinib group versus 21.1 months ( 16.3-30.7 ) in the chemotherapy group ( HR 0.54 , 95 % CI 0.36-0.79 , p=0.0015 ) ; in LUX-Lung 6 , it was 31.4 months ( 95 % CI 24.2-35.3 ) versus 18.4 months ( 14.6-25.6 ) , respectively ( HR 0.64 , 95 % CI 0.44-0.94 , p=0.023 ) . By contrast , there were no significant differences by treatment group for patients with EGFR Leu858Arg-positive tumours in either trial : in LUX-Lung 3 , median overall survival was 27.6 months ( 19.8-41.7 ) in the afatinib group versus 40.3 months ( 24.3-not estimable ) in the chemotherapy group ( HR 1.30 , 95 % CI 0.80-2.11 , p=0.29 ) ; in LUX-Lung 6 , it was 19.6 months ( 95 % CI 17.0-22.1 ) versus 24.3 months ( 19.0-27.0 ) , respectively ( HR 1.22 , 95 % CI 0.81-1.83 , p=0.34 ) . In both trials , the most common afatinib-related grade 3-4 adverse events were rash or acne ( 37 [ 16 % ] of 229 patients in LUX-Lung 3 and 35 [ 15 % ] of 239 patients in LUX-Lung 6 ) , diarrhoea ( 33 [ 14 % ] and 13 [ 5 % ] ) , paronychia ( 26 [ 11 % ] in LUX-Lung 3 only ) , and stomatitis or mucositis ( 13 [ 5 % ] in LUX-Lung 6 only ) . In LUX-Lung 3 , neutropenia ( 20 [ 18 % ] of 111 patients ) , fatigue ( 14 [ 13 % ] ) and leucopenia ( nine [ 8 % ] ) were the most common chemotherapy-related grade 3-4 adverse events , while in LUX-Lung 6 , the most common chemotherapy-related grade 3-4 adverse events were neutropenia ( 30 [ 27 % ] of 113 patients ) , vomiting ( 22 [ 19 % ] ) , and leucopenia ( 17 [ 15 % ] ) . INTERPRETATION Although afatinib did not improve overall survival in the whole population of either trial , overall survival was improved with the drug for patients with del19 EGFR mutations . The absence of an effect in patients with Leu858Arg EGFR mutations suggests that EGFR del19-positive disease might be distinct from Leu858Arg-positive disease and that these subgroups should be analysed separately in future trials . FUNDING Boehringer Ingelheim .
|
{
"P": [
"EGFR mutation-positive lung adenocarcinoma ( LUX-Lung 3",
"LUX-Lung 6",
"patients with EGFR mutation-positive lung adenocarcinoma",
"adenocarcinoma",
"n=345",
"n=364",
"345",
"patients with EGFR",
"229 patients",
"239 patients",
"patients with del19 EGFR mutations",
"patients with Leu858Arg EGFR mutations"
],
"I": [
"Afatinib",
"cisplatin-based chemotherapy",
"afatinib",
"LUX-Lung",
"LUX-Lung 6",
"chemotherapy ( pemetrexed-cisplatin [ LUX-Lung 3 ]",
"gemcitabine-cisplatin [ LUX-Lung 6 ] )"
],
"O": [
"overall survival",
"grade 3-4 adverse events",
"rash or acne",
"diarrhoea",
"paronychia",
"stomatitis or mucositis",
"neutropenia",
"fatigue",
"leucopenia",
"vomiting"
]
}
|
A randomized , double-blind , vehicle-controlled study to assess 5 % imiquimod cream for the treatment of multiple actinic keratoses . BACKGROUND Actinic keratoses ( AKs ) are precancerous epidermal lesions found most frequently on areas of the skin exposed to the sun . Several case studies published recently have indicated that 5 % imiquimod cream , currently licensed for the treatment of genital warts , may be an effective treatment for AK . OBJECTIVE To assess the efficacy and safety of imiquimod for the treatment of AK . DESIGN Patients in this randomized , double-blind , vehicle-controlled study applied 5 % imiquimod cream or vehicle to AK lesions 3 times per week for a maximum of 12 weeks or until lesions had resolved . In the event of an adverse reaction , application of imiquimod was reduced to 1 or 2 times per week . Rest periods were also allowed if necessary . SETTING A specialized outpatient dermatology clinic within a state-funded hospital in Germany . PATIENTS The study population was aged 45 to 85 years . Of 52 patients screened , 36 men and women with AK confirmed by histological diagnosis were enrolled . Patients were excluded from the study if they did not have a histological diagnosis for AK , if they were older than 85 years , or if they did not comply with the protocol . All patients had responded to a notice asking for volunteers . MAIN OUTCOME MEASURES The number and appearance of lesions were evaluated before , during , and after treatment . All adverse effects were recorded . RESULTS Lesions treated with 5 % imiquimod cream were clinically cleared in 21 ( 84 % ) of 25 patients and partially cleared in 2 ( 8 % ) . Clearance was histologically confirmed 2 weeks after the last application of imiquimod in all patients clinically diagnosed as lesion free . Only 10 % of patients treated with imiquimod were clinically diagnosed with recurrence 1 year after treatment . No reduction in the size or number of AK lesions was observed in vehicle-treated patients . Adverse effects reported by patients treated with imiquimod included erythema , edema , induration , vesicles , erosion , ulceration , excoriation , and scabbing . However , imiquimod was well tolerated since all patients completed the 12-week treatment . Only a few , mild adverse reactions to the vehicle cream were reported . CONCLUSION Application of 5 % imiquimod cream for 12 weeks is an effective and well-tolerated treatment for AK .
|
{
"P": [
"multiple actinic keratoses",
"45 to 85",
"52",
"men and women"
],
"I": [
"imiquimod cream",
"imiquimod"
],
"O": [
"multiple actinic keratoses",
"Actinic keratoses ( AKs )",
"AK",
"AK lesions",
"number and appearance of lesions",
"adverse effects",
"clinically cleared",
"partially cleared",
"Clearance",
"reduction in the size or number of AK lesions",
"erythema , edema , induration , vesicles , erosion , ulceration , excoriation , and scabbing",
"tolerated"
]
}
|
Levamisole versus placebo as an adjunct to primary therapy of laryngopharyngeal epidermoid carcinoma . Evaluation of the immune status . Twenty-four patients , with a biopsy-proven laryngeal or hypopharyngeal carcinoma , received as an adjunct to their primary treatment ( surgery and/or radiotherapy ) , levamisole ( 150 mg daily during three consecutive days , every fortnight ) or placebo , following a single-blind , but randomized method . At the end of the follow-up , an investigation of the immune status was done , and compared with that of a healthy control-group . It is concluded that the immunity is disturbed in patients with laryngo-pharyngeal cancer , but that this disturbance does not clearly correlate with the clinical state of the disease . Also , the immunological measures did not appear relevant to the significantly favourable effect of levamisole on the prognosis .
|
{
"P": [],
"I": [
"Levamisole",
"placebo",
"levamisole"
],
"O": [
"immune",
"immunity"
]
}
|
Total anthelmintic failure to control nematode parasites of small ruminants on government breeding farms in Sabah , East Malaysia . Government-owned small-ruminant breeding farms in Malaysia provide the source of sheep and goats to smallholder farmers in the country . In the eastern Malaysian state of Sabah , high-level stock losses have been recorded on these farms for several years , frequently accompanied by clinical signs indicating pathogenic levels of infections with the nematode parasite Haemonchus contortus . This suggests that their dependence on chemotherapy to control parasite infections had failed . Accordingly , tests for anthelmintic efficacy using the faecal egg count reduction test ( FECRT ) on the range of drugs used to control nematode parasites were carried out on the five government small-ruminant breeding farms in Sabah . These tests showed a total failure of the benzimidazole , imidothiazole , macrocyclic lactone and salicylanilide groups of anthelmintics to control H. contortus infections of sheep and goats on all farms . Drastic changes in animal management need to be made in an attempt to deal with this situation , for which suggestions are made .
|
{
"P": [
"nematode parasites",
"nematode parasite Haemonchus contortus"
],
"I": [
"faecal egg count reduction test",
"benzimidazole , imidothiazole , macrocyclic lactone",
"salicylanilide"
],
"O": [
"anthelmintic efficacy",
"faecal egg count reduction test ( FECRT )",
"failure of the benzimidazole , imidothiazole , macrocyclic lactone and salicylanilide groups of anthelmintics",
"H. contortus infections"
]
}
|
Efficacy of outpatient induction with low-dose intravaginal prostaglandin E2 : a randomized , double-blind , placebo-controlled trial . OBJECTIVE Our purpose was to determine whether a protocol for outpatient induction is safe and effective for initiating labor . STUDY DESIGN A randomized , double-blind , placebo-controlled trial was performed with 100 low-risk patients having well-dated pregnancies . Women with a Bishop score < or = 6 at 38 to 40 weeks ' gestation were administered either 2 mg of intravaginal prostaglandin E2 gel or placebo for 5 consecutive days as outpatients while undergoing fetal monitoring . RESULTS The median interval from randomization to delivery was 4 days in the prostaglandin E2 group ( range 0 to 28 days ) versus 10 days in the placebo group ( range 0 to 26 days , p = 0.002 ) . Twenty-seven of 50 patients ( 54 % ) in the prostaglandin E2 group were admitted for labor during the dosing interval compared with 10 placebo-treated patients ( 20 % , p = 0.001 ) . The mean gestational age at delivery was significantly reduced in the treatment group ( 39.9 +/- 1.0 weeks vs 40.5 +/- 0.99 weeks , p = 0.003 ) as was the incidence of postdates pregnancy ( 40 % vs 66 % , p = 0.016 ) . Hyperstimulation was observed in one prostaglandin E2-treated patient , but no intervention was required . CONCLUSIONS Outpatient low-dose prostaglandin E2 gel administration is effective for initiating labor in patients with an unfavorable cervix and appears safe if performed with adequate monitoring .
|
{
"P": [
"100",
"pregnancies",
"Bishop score < or = 6",
"38 to 40 weeks ' gestation",
"50",
"unfavorable cervix"
],
"I": [
"prostaglandin E2 :",
"placebo-controlled",
"intravaginal prostaglandin E2 gel or placebo",
"prostaglandin E2",
"placebo",
"prostaglandin E2-treated",
"prostaglandin E2 gel"
],
"O": [
"Efficacy",
"interval from randomization to delivery",
"admitted for labor during the dosing interval",
"mean gestational age at delivery",
"incidence of postdates pregnancy",
"Hyperstimulation",
"effective",
"initiating labor"
]
}
|
Internet-based program for coping with cancer : a randomized controlled trial with hematologic cancer patients . OBJECTIVE Psychosocial patient care in oncology is no longer limited to the inpatient setting . Outpatient services are in demand . Internet-based interventions could aid in optimizing service delivery across disciplines . The effectiveness of an Internet-based program for hematologic cancer patients was tested in a randomized controlled trial under field experimental conditions . METHODS A 4-week cognitive-behavioral program for coping with cancer was offered to hematologic cancer patients online . One hundred eighty-six registrants were randomly assigned to an intervention group ( n = 105 ) or a waiting list ( n = 81 ) . The outcome measures , 'mental adjustment ' ( MAC ) and 'psychological distress ' ( BSI ) , were assessed at registration and after 4 weeks . Patient satisfaction was assessed ( ZUF-8 ) , and complete-cases and intention-to-treat analyses were performed . RESULTS At registration , the majority of participants displayed clinically significant distress ( BSI ) and lacked alternative access concerning psychosocial care . One hundred eleven patients filled out the post questionnaire at 4 weeks . In contrast to the waiting list , the intervention group displayed a significant increase in fighting spirit ( d = 0.42 ; CI 95 % , 0.04 to 0.80 ) . The effect was confirmed by intention-to-treat analysis ( d = 0.33 ; CI 95 % , 0.04 to 0.62 ) . Otherwise , no effects were observed . Patient satisfaction with the program was high . CONCLUSION The results demonstrate the potential efficacy of Internet-based programs while highlighting their limitations . Future research is needed to clarify and optimize efficacy , taking different program components and patient characteristics into particular consideration .
|
{
"P": [
"hematologic cancer",
"One hundred eighty-six registrants",
"One hundred eleven patients"
],
"I": [
"Internet-based program",
"Internet-based interventions",
"4-week cognitive-behavioral program for coping",
"intervention group",
"waiting list"
],
"O": [
"'mental adjustment ' ( MAC ) and 'psychological distress ' ( BSI )",
"Patient satisfaction",
"( BSI )",
"fighting spirit"
]
}
|
The immunogenicity of three Haemophilus influenzae type B conjugate vaccines after a primary vaccination series in Philippine infants . Serum antibody responses to three Haemophilus influenzae type b ( Hib ) capsular polysaccharide-protein conjugate vaccine ( PRP-OMP , PRP-T , and HbOC ) were evaluated in 174 Philippine infants after a primary vaccination series . Children were randomized to receive one of the Hib vaccines ( Hib groups ) or into a control group . Vaccination was carried out at six , 10 and 14 weeks of age based on the local Expanded Program of Immunization schedule . Sera were collected at six weeks of age for the Hib groups and one month after the third dose for all subjects . Anti-Hib concentrations were determined by the Farr-type radioimmunoassay . There were no significant differences ( P = 0.3626 ) in the prevaccination anti-Hib geometric mean concentration ( GMC ) among the three Hib groups . Differences in the GMC after the primary series of three doses were significant ( P < 0.0001 ) ; GMC was highest for PRP-T ( 6.62 micrograms/ml ) , followed by HbOC ( 1.9 micrograms/ml ) , then PRP-OMP ( 1.06 micrograms/ml ) , and lowest for the control group ( 0.11 microgram/ml ) . We conclude that all three Hib conjugate vaccines ( PRP-T , HbOC , and PRP-OMP ) were immunogenic after three primary doses among Philippine infants .
|
{
"P": [
"infants",
"174",
"primary vaccination"
],
"I": [
"Haemophilus influenzae type B conjugate vaccines",
"Haemophilus influenzae type b ( Hib ) capsular polysaccharide-protein conjugate vaccine ( PRP-OMP , PRP-T , and HbOC )",
"Hib vaccines ( Hib groups )",
"control group",
"Hib conjugate vaccines",
"PRP-T",
"HbOC",
"PRP-OMP"
],
"O": [
"immunogenicity",
"Serum antibody responses",
"Anti-Hib concentrations",
"prevaccination anti-Hib geometric mean concentration ( GMC )",
"GMC",
"immunogenic"
]
}
|
FloSeal hemostatic matrix in persistent epistaxis : prospective clinical trial . OBJECTIVE Although most cases of epistaxis are managed conservatively , occasionally they can progress to significant hemorrhage requiring more involved management or surgery . Endoscopic ligation surgery is the current institutional standard of care for patients who fail conservative management . However , surgical ligation requires availability of surgical resources and patients who are able to withstand an anesthetic . This study 's objective was to determine the efficacy of FloSeal hemostatic matrix ( Baxter Healthcare Corporation , Hayward , CA ) in epistaxis refractory to nasal packing . METHODS A prospective clinical trial was conducted on epistaxis patients whose nasal hemorrhage persisted despite adequate nasal packing by the otolaryngology-head and neck surgery team . Once enrolled , patients are given a trial of intranasal FloSeal hemostatic matrix to abort the epistaxis . Should this fail , patients then proceed with surgical clipping . RESULTS Our prospective cohort demonstrated significant success in 80 % of patients with persistent epistaxis , who would have otherwise been taken to the operating theatre , avoiding the need for further surgical intervention . The majority of enrolled patients with persistent nasal hemorrhage were adequately managed with the hemostatic matrix alone and were discharged from hospital in a timeframe comparable to that of surgical managment . CONCLUSIONS This study revealed a highly effective tool in the otolaryngologist 's management of persistent epistaxis . Given the ease of use , decreased morbidity to the patient , and cost-effectiveness , FloSeal hemostatic matrix could change clinical practice in managing this common condition .
|
{
"P": [
"persistent epistaxis :",
"80 % of patients with persistent epistaxis"
],
"I": [
"FloSeal hemostatic matrix"
],
"O": [
"surgical intervention",
"discharged from hospital"
]
}
|
Components of working memory and visual selective attention . Load theory ( Lavie , N. , Hirst , A. , De Fockert , J. W. , & Viding , E. [ 2004 ] . Load theory of selective attention and cognitive control . Journal of Experimental Psychology : General , 133 , 339-354 . ) proposes that control of attention depends on the amount and type of load that is imposed by current processing . Specifically , perceptual load should lead to efficient distractor rejection , whereas working memory load ( dual-task coordination ) should hinder distractor rejection . Studies support load theory 's prediction that working memory load will lead to larger distractor effects ; however , these studies used secondary tasks that required only verbal working memory and the central executive . The present study examined which other working memory components ( visual , spatial , and phonological ) influence visual selective attention . Subjects completed an attentional capture task alone ( single-task ) or while engaged in a working memory task ( dual-task ) . Results showed that along with the central executive , visual and spatial working memory influenced selective attention , but phonological working memory did not . Specifically , attentional capture was larger when visual or spatial working memory was loaded , but phonological working memory load did not affect attentional capture . The results are consistent with load theory and suggest specific components of working memory influence visual selective attention .
|
{
"P": [
"visual selective attention"
],
"I": [
"attentional capture task alone ( single-task )",
"working memory task ( dual-task )"
],
"O": [
"control of attention",
"amount and type of load",
"distractor rejection .",
"distractor effects ;",
"visual selective attention .",
"attentional capture task",
"selective attention",
"attentional capture",
"visual selective attention"
]
}
|
Dark-phase light contamination disrupts circadian rhythms in plasma measures of endocrine physiology and metabolism in rats . Dark-phase light contamination can significantly disrupt chronobiologic rhythms , thereby potentially altering the endocrine physiology and metabolism of experimental animals and influencing the outcome of scientific investigations . We sought to determine whether exposure to low-level light contamination during the dark phase influenced the normally entrained circadian rhythms of various substances in plasma . Male Sprague-Dawley rats ( n = 6 per group ) were housed in photobiologic light-exposure chambers configured to create 1 ) a 12:12-h light : dark cycle without dark-phase light contamination ( control condition ; 123 μW/cm ( 2 ) , lights on at 0600 ) , 2 ) experimental exposure to a low level of light during the 12-h dark phase ( with 0.02 , 0.05 , 0.06 , or 0.08 μW/cm ( 2 ) light at night ) , or 3 ) constant bright light ( 123 μW/cm ( 2 ) ) . Dietary and water intakes were recorded daily . After 2 wk , rats underwent 6 low-volume blood draws at 4-h intervals ( beginning at 0400 ) during both the light and dark phases . Circadian rhythms in dietary and water intake and levels of plasma total fatty acids and lipid fractions remained entrained during exposure to either control conditions or low-intensity light during the dark phase . However , these patterns were disrupted in rats exposed to constant bright light . Circadian patterns of plasma melatonin , glucose , lactic acid , and corticosterone were maintained in all rats except those exposed to constant bright light or the highest level of light during the dark phase . Therefore even minimal light contamination during the dark phase can disrupt normal circadian rhythms of endocrine metabolism and physiology and may alter the outcome of scientific investigations .
|
{
"P": [
"endocrine physiology and metabolism",
"6 per group"
],
"I": [
"Dark-phase light contamination",
"photobiologic light-exposure chambers",
"light : dark cycle without dark-phase light contamination"
],
"O": [
"plasma",
"physiology",
"metabolism",
"chronobiologic rhythms"
]
}
|
A randomized trial of a behavioral intervention for black MSM : the DiSH study . OBJECTIVE To test a new behavioral intervention for black MSM in reducing sexual risk and increasing social support and intentions to use condoms . DESIGN A single-site , unblinded randomized trial in New York City with 3-month follow-up . METHODS Participants ( n = 283 ) reporting at least two sexual partners and unprotected anal intercourse with a man in the past 3 months were enrolled and randomized to a social-cognitive theory-based intervention or control comparison . Men in the intervention group participated in five 2-h group sessions focused on creating a group environment with sexual risk-reduction information and exercises woven into joint meal preparation and sharing activities , while exploring self-efficacy perceptions and outcome expectancies . Intervention ( n = 142 ) and control ( n = 141 ) groups received standard HIV counseling and testing at baseline . RESULTS No significant differences were found between study arms at 3 months in number of male partners , number of unprotected anal intercourse partners , proportion reporting unprotected sex , number of acts protected by condoms , self-efficacy , condom attitudes , condom intentions , social isolation and psychological distress . In both arms combined , declines from baseline to 3 months were observed in sexual risk behaviors , social isolation and psychological distress , whereas self-efficacy , condom attitudes and condom intentions improved . CONCLUSION As the HIV epidemic continues to have a dramatic impact on black MSM in the USA , the urgency to design innovative interventions continues .
|
{
"P": [
"283"
],
"I": [
"behavioral intervention",
"social-cognitive theory-based intervention",
"or",
"control comparison"
],
"O": [
"number of male partners , number of unprotected anal intercourse partners , proportion reporting unprotected sex , number of acts protected by condoms , self-efficacy , condom attitudes , condom intentions , social isolation and psychological distress",
"sexual risk behaviors , social isolation and psychological distress",
"self-efficacy , condom attitudes and condom"
]
}
|
Oat ingestion reduces systolic and diastolic blood pressure in patients with mild or borderline hypertension : a pilot trial . OBJECTIVES We assessed the short-term antihypertensive effects of soluble fiber-rich whole oat cereals when added to a standard American diet . In addition , multiple assessments of insulin sensitivity were conducted . STUDY DESIGN This was a randomized , controlled , parallel-group pilot study designed to compare an oat cereal group ( standardized to 5.52 g/day beta-glucan ) to a low-fiber cereal control group ( less than 1.0 g/day total fiber ) over 6 weeks . POPULATION A total of 18 hypertensive and hyperinsulinemic ( = 10 U/mL or more ) men and women completed the trial . OUTCOMES MEASURED Primary study outcomes were changes in systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) . Secondary outcomes included blood lipid , fasting glucose , and insulin levels and side effects related to elevated blood pressure and increased dietary fiber intake . RESULTS The oat cereal group experienced a 7.5 mm Hg reduction in SBP ( P & lt.01 ) and a 5.5 mm Hg reduction in DBP ( P & lt.02 ) , while there was virtually no change in either SBP or DBP in the control group . In the oat cereal group , a trend was observed for a lower total insulin response to a glucose load , suggesting improved insulin sensitivity . However , this could not be confirmed using estimates from the Bergman Minimal Model , perhaps because of our small sample size . The oats group experienced a significant reduction in both total cholesterol ( 9 % ) and low-density lipoprotein cholesterol ( 14 % ) . CONCLUSIONS The addition of oat cereals to the normal diet of patients with hypertension significantly reduces both SBP and DBP . Soluble fiber-rich whole oats may be an effective dietary therapy in the prevention and adjunct treatment of hypertension .
|
{
"P": [
"patients with mild or borderline hypertension :"
],
"I": [
"Oat ingestion",
"soluble fiber-rich whole oat cereals",
"oat cereal group ( standardized to 5.52 g/day beta-glucan )",
"a low-fiber cereal control group ( less than 1.0 g/day total fiber )",
"oat cereals",
"Soluble fiber-rich whole oats"
],
"O": [
"systolic blood pressure ( SBP )",
"diastolic blood pressure ( DBP )",
"blood lipid",
"fasting glucose",
"insulin levels",
"side effects related to elevated blood pressure and increased dietary fiber intake",
"SBP",
"DBP",
"total insulin response",
"total cholesterol",
"low-density lipoprotein cholesterol"
]
}
|
Prospective randomized comparison between transperitoneal laparoscopic pyeloplasty and retroperitoneoscopic pyeloplasty for primary ureteropelvic junction obstruction . BACKGROUND AND OBJECTIVES To compare laparoscopic transperitoneal versus retroperitoneoscopic pyeloplasty for primary ureteropelvic junction obstruction in a prospective randomized manner and assess overall results with long-term follow-up . METHODS In this prospective study , from 2008 to 2012 , 112 cases of primary ureteropelvic junction obstruction were randomized in a 1:1 ratio into 2 groups . Group I included patients who underwent transperitoneal laparoscopic pyeloplasty , and group II consisted of patients who underwent retroperitoneoscopic laparoscopic pyeloplasty . Demographic and clinical characteristics and postoperative and operative data were collected and analyzed . The statistical analysis was performed with the Fisher exact test , χ2 test , and Mann-Whitney U test for independent groups , and P < .05 was considered statistically significant . RESULTS The total operative time and intracorporeal suturing time were significantly higher in group II than in group I ( P < .001 ) . The visual analog scale score for pain on postoperative day 1 and the requirement for tramadol were significantly higher in group I than in group II ( P=.004 ) . The hospital stay and the rate of temporary ileus were significantly greater ( P < .036 and P < .02 , respectively ) in group I than in group II . The success rate of transperitoneal laparoscopic pyeloplasty versus retroperitoneoscopic laparoscopic pyeloplasty was 96.4 % versus 96.6 % with a mean follow-up period of 30.75±4.85 months versus 30.99±5.59 months ( P < .88 ) . CONCLUSION Transperitoneal laparoscopic pyeloplasty is associated with significantly greater postoperative pain , a higher tramadol dose , a higher rate of ileus , and a longer hospital stay in comparison with retroperitoneoscopic laparoscopic pyeloplasty . Although the operative time for retroperitoneoscopic laparoscopic pyeloplasty is significantly longer , the success rate remains the same for both procedures .
|
{
"P": [
"primary ureteropelvic junction obstruction",
"transperitoneal laparoscopic pyeloplasty",
"retroperitoneoscopic laparoscopic pyeloplasty"
],
"I": [
"transperitoneal laparoscopic pyeloplasty",
"retroperitoneoscopic pyeloplasty",
"laparoscopic transperitoneal",
"retroperitoneoscopic laparoscopic pyeloplasty"
],
"O": [
"The total operative time",
"intracorporeal suturing time",
"The visual analog scale score for pain",
"hospital stay",
"rate of temporary ileus",
"The success rate"
]
}
|
Immunologic profiles of persons recruited for a randomized , placebo-controlled clinical trial of hookworm infection . Data from epidemiologic studies suggest that hookworm infections , in establishing an immunologic phenotype conducive to parasite survival , may protect against the development of allergic disease . We describe immunologic findings from a clinical study designed to investigate the safety of iatrogenic hookworm infection in participants with allergic rhinitis . The low , relatively safe level of hookworm infection used in this study was immunogenic , inducing eosinophilia and a significant specific IgG response . Importantly , no potentiation of IgE responses to the environmental allergens to which the participants were sensitized was seen . However , no evidence of systemic immune regulation was seen in infected participants . This finding may indicate that the level of infection or the frequency of infection may have to be altered in future trials to induce a therapeutically conducive immunologic phenotype .
|
{
"P": [],
"I": [
"placebo-controlled",
"iatrogenic hookworm infection",
"hookworm infection"
],
"O": [
"eosinophilia",
"specific IgG response .",
"IgE responses to the environmental allergens to which the participants were sensitized",
"systemic immune regulation",
"level of infection",
"frequency of infection"
]
}
|
Predictors of blood pressure change in a series of controlled dietary intervention studies . Three controlled dietary intervention studies were carried out in 1981-1983 in North Karelia , Finland , to asses the impact of dietary fat intake modification on blood pressure ( BP ) . All these studies involved middle-aged men and women in rural or semirural areas and comprised a baseline period , a six week ( or 12 weeks in the third study ) intervention period and a four to six week return to baseline . During the intervention period the total fat intake was reduced from 39 % to 24 % of energy and the polyunsaturated/saturated ( P/S ) ratio increased from 0.2 to 0.4-1.2 . In all groups energy intake was kept constant . For the present report data from the three studies were pooled for a series of stepwise regression analyses to predict changes in BP with different dietary changes . For both systolic ( SBP ) and diastolic ( DBP ) blood pressure , change in polyunsaturated fatty acid intake was the strongest dietary predictor of BP change . Changes in body weight , total fat intake , urinary sodium and potassium did not have significant predictive power in any of the analyses . The findings support the hypothesis that modification of dietary fat intake is a significant predictor of change in BP .
|
{
"P": [
"1981-1983 in North Karelia , Finland",
"middle-aged men and women in rural or semirural areas and comprised a baseline period , a six week ( or 12 weeks in the third study ) intervention period and a four to six week return to baseline ."
],
"I": [
"dietary intervention",
"fat intake",
"polyunsaturated/saturated ( P/S ) ratio"
],
"O": [
"blood pressure change",
"blood pressure ( BP )",
"total fat intake",
"BP",
"systolic ( SBP ) and diastolic ( DBP ) blood pressure",
"BP change",
"body weight , total fat intake , urinary sodium and potassium"
]
}
|
Sodium kinetics in white and black normotensive subjects : possible relevance to salt-sensitive hypertension . The hypothesis that sodium ( Na ) kinetics are not a first order process was tested . Twelve normotensive white and 12 normotensive black men were given 10 , 200 , and 400 mmol/d Na as the chloride salt for 7 days in random order . All urine made was collected . No effect of Na intake on blood pressure was identified in either whites or blacks . The half-life ( T1/2 ) with decreasing Na intake to 10 mmol/d was 1.08 days in whites and 1.65 days in blacks ( p = not significant [ NS ] ) . With increasing Na intake , T1/2 increased in both whites and blacks ; at the 400 mmol/d intake , the T1/2 for whites was 2.88 days and for blacks was 5.81 days ( p < 0.05 ) . At that intake , whites accumulated 385 +/- 153 mmol compared with 909 +/- 153 mmol for blacks ( p < 0.05 ) . The data showed that T1/2 increases with increasing Na intake and is , therefore , dose-dependent or " zero " order . The effect of dose is more prominent in blacks than in whites ; blacks accumulate more Na with increasing Na intake than whites . These data may have relevance for the pathogenesis of salt-sensitive hypertension in blacks .
|
{
"P": [
"Twelve normotensive white",
"12 normotensive black men"
],
"I": [
"sodium",
"Na as the chloride salt",
"Na"
],
"O": [
"blood pressure",
"half-life ( T1/2 )",
"T1/2 increased",
"accumulated",
"T1/2 increases",
"effect",
"accumulate more Na"
]
}
|
Chemotherapy with cyclophosphamide , doxorubicin , vincristine , and prednisone alone or with levamisole or with levamisole plus BCG for malignant lymphoma : a Southwest Oncology Group Study . Between 1977 and 1983 the Southwest Oncology Group ( SWOG ) evaluated chemotherapy alone ( cyclophosphamide , doxorubicin , vincristine , prednisone ; CHOP ) or chemoimmunotherapy ( CHOP-levamisole or CHOP-levamisole-BCG ) in a randomized prospective clinical trial involving 715 eligible patients with all types of malignant lymphoma ( ML ) . Of 281 evaluable patients with favorable histologic types of ML , 171 ( 61 % ) achieved complete remission ( CR ) and there was no difference in CR rate , CR duration , or survival according to the type of initial treatment . Of 388 evaluable patients with unfavorable histologic types of ML , 194 ( 50 % ) achieved CR . Levamisole appeared to adversely affect CR rates in nodular mixed and nodular large-cell lymphoma and CR duration in patients with unfavorable histology ML . Chemoimmunotherapy with levamisole or levamisole-BCG offers no advantage in terms of CR rates , CR duration , or survival compared to CHOP chemotherapy alone , and levamisole may have had an adverse impact on outcome in certain subtypes of ML .
|
{
"P": [
"715",
"malignant lymphoma",
"281",
"ML",
"388"
],
"I": [
"Chemotherapy with cyclophosphamide , doxorubicin , vincristine , and prednisone alone or with levamisole or with levamisole plus BCG for",
"chemotherapy alone ( cyclophosphamide , doxorubicin , vincristine , prednisone ; CHOP )",
"chemoimmunotherapy ( CHOP-levamisole or CHOP-levamisole-BCG )",
"Levamisole",
"Chemoimmunotherapy with levamisole or levamisole-BCG",
"CHOP chemotherapy",
"levamisole"
],
"O": [
"complete remission ( CR )",
"CR rate , CR duration , or survival",
"CR",
".",
"CR rates",
"CR duration",
",",
"CR duration ,",
"or",
"survival"
]
}
|
Multiple sclerosis risk after optic neuritis : final optic neuritis treatment trial follow-up . OBJECTIVE To assess the risk of developing multiple sclerosis ( MS ) after optic neuritis and the factors predictive of high and low risk . DESIGN Subjects in the Optic Neuritis Treatment Trial , who were enrolled between July 1 , 1988 , and June 30 , 1991 , were followed up prospectively for 15 years , with the final examination in 2006 . SETTING Neurologic and ophthalmologic examinations at 13 clinical sites . PARTICIPANTS Three hundred eighty-nine subjects with acute optic neuritis . MAIN OUTCOME MEASURES Development of MS and neurologic disability assessment . RESULTS The cumulative probability of developing MS by 15 years after onset of optic neuritis was 50 % ( 95 % confidence interval , 44 % -56 % ) and strongly related to presence of lesions on a baseline non-contrast-enhanced magnetic resonance imaging ( MRI ) of the brain . Twenty-five percent of patients with no lesions on baseline brain MRI developed MS during follow-up compared with 72 % of patients with 1 or more lesions . After 10 years , the risk of developing MS was very low for patients without baseline lesions but remained substantial for those with lesions . Among patients without lesions on MRI , baseline factors associated with a substantially lower risk for MS included male sex , optic disc swelling , and certain atypical features of optic neuritis . CONCLUSIONS The presence of brain MRI abnormalities at the time of an optic neuritis attack is a strong predictor of the 15-year risk of MS . In the absence of MRI-detected lesions , male sex , optic disc swelling , and atypical clinical features of optic neuritis are associated with a low likelihood of developing MS . This natural history information is important when considering prophylactic treatment for MS at the time of a first acute onset of optic neuritis .
|
{
"P": [
"optic neuritis",
"Three hundred eighty-nine",
"acute optic neuritis"
],
"I": [
"Optic Neuritis Treatment",
"brain MRI"
],
"O": [
"Multiple sclerosis risk",
"risk of developing multiple sclerosis ( MS )",
"Development of MS",
"neurologic disability assessment",
"cumulative probability of developing MS by 15 years after onset of optic neuritis",
"MS",
"risk of developing MS",
"risk for MS",
"the 15-year risk of MS",
"developing MS"
]
}
|
Measuring and supporting language function for children with autism : evidence from a randomized control trial of a social-interaction-based therapy . In a report of the effectiveness of MEHRIT , a social-interaction-based intervention for autism , Casenhiser et al . ( Autism 17 ( 2 ) :220-241 , 2013 ) failed to find a significant advantage for language development in the treatment group using standardized language assessments . We present the results from a re-analysis of their results to illustrate the importance of measuring communicative language acts ( formally called " speech acts " ) . Reanalysis confirmed that children in the MEHRIT group outperformed the community treatment group on measures of MLUm , number of utterances produced , and various speech act categories . The study underscores the importance of functional language measures in guiding and evaluating treatment for children with autism , and suggests that MEHRIT is effective in improving children 's use of language during parent-child interactions .
|
{
"P": [
"children",
"autism"
],
"I": [
"social-interaction-based therapy",
"MEHRIT , a social-interaction-based intervention",
"MEHRIT"
],
"O": [
"effectiveness",
"communicative language acts",
"outperformed",
"MLUm , number of utterances produced , and various speech act categories .",
"functional language measures",
"children 's use of language during parent-child interactions"
]
}
|
Folate and arsenic metabolism : a double-blind , placebo-controlled folic acid-supplementation trial in Bangladesh . BACKGROUND Populations in South and East Asia and many other regions of the world are chronically exposed to arsenic-contaminated drinking water . To various degrees , ingested inorganic arsenic ( InAs ) is methylated to monomethylarsonic acid ( MMA ) and dimethylarsinic acid ( DMA ) via folate-dependent one-carbon metabolism ; impaired methylation is associated with adverse health outcomes . Consequently , folate nutritional status may influence arsenic methylation and toxicity . OBJECTIVE The objective of this study was to test the hypothesis that folic acid supplementation of arsenic-exposed adults would increase arsenic methylation . DESIGN Two hundred adults in a rural region of Bangladesh , previously found to have low plasma concentrations of folate ( < /=9 nmol/L ) were enrolled in a randomized , double-blind , placebo-controlled folic acid-supplementation trial . Plasma concentrations of folate and homocysteine and urinary concentrations of arsenic metabolites were analyzed at baseline and after 12 wk of supplementation with folic acid at a dose of 400 microg/d or placebo . RESULTS The increase in the proportion of total urinary arsenic excreted as DMA in the folic acid group ( 72 % before and 79 % after supplementation ) was significantly ( P < 0.0001 ) greater than that in the placebo group , as was the reduction in the proportions of total urinary arsenic excreted as MMA ( 13 % and 10 % , respectively ; P < 0.0001 ) and as InAs ( 15 % and 11 % , respectively ; P < 0.001 ) . CONCLUSIONS These data indicate that folic acid supplementation to participants with low plasma folate enhances arsenic methylation . Because persons whose urine contains low proportions of DMA and high proportions of MMA and InAs have been reported to be at greater risk of skin and bladder cancers and peripheral vascular disease , these results suggest that folic acid supplementation may reduce the risk of arsenic-related health outcomes .
|
{
"P": [
"chronically exposed to arsenic-contaminated drinking water",
"Two hundred",
"adults",
"low plasma concentrations of folate ( < /=9 nmol/L )",
"low plasma folate"
],
"I": [
"placebo-controlled",
"folic acid-supplementation",
"folic acid supplementation",
"supplementation with folic acid",
"placebo",
"folic acid"
],
"O": [
"arsenic methylation",
"Plasma concentrations of folate and homocysteine and urinary concentrations of arsenic metabolites",
"proportion of total urinary arsenic",
"total urinary arsenic excreted"
]
}
|
Clinical significance and prognostic importance of left ventricular hypertrophy in non-Q-wave acute myocardial infarction . Left ventricular ( LV ) hypertrophy is known to be an independent risk factor for cardiac death , but its significance in non-Q-wave acute myocardial infarction ( AMI ) has not been assessed previously . In a randomized diltiazem-placebo-controlled therapeutic trial of non-Q-wave AMI confirmed by creatine kinase-MB ( CK-MB ) , 126 of 544 patients ( 23 % ) exhibited LV hypertrophy using standard voltage criteria . Compared to patients without LV hypertrophy , patients with LV hypertrophy were significantly older ( 65 vs 60 years , p less than 0.0001 ) and had smaller peak adjusted CK levels ( 490 +/- 376 vs 666 +/- 726 IU/liter , p less than 0.001 ) than patients without LV hypertrophy . Patients with and without LV hypertrophy did not differ significantly in acute mortality during hospitalization , progression to Q waves , reinfarction by CK-MB criteria or angina associated with transient electrocardiographic changes . Compared with patients without LV hypertrophy , those patients with non-Q-wave AMI and LV hypertrophy had a 2-fold higher incidence of reinfarction ( 24 vs 12 % , p less than 0.005 ) and death ( 19 vs 9 % , p = 0.044 ) during the first year of follow-up . Multivariate regression analysis revealed that the relative risk of death and reinfarction during the initial year after AMI was increased by a factor of 1.7 and 2.1 among patients with LV hypertrophy , respectively . It was therefore concluded that , although patients with LV hypertrophy and non-Q-wave AMI have smaller enzymatic infarcts and the same short-term prognosis as do patients without LV hypertrophy , their reinfarction and mortality rates are significantly increased during the first year of follow-up . ( ABSTRACT TRUNCATED AT 250 WORDS )
|
{
"P": [
"non-Q-wave acute myocardial infarction",
"non-Q-wave acute myocardial infarction ( AMI )"
],
"I": [
"diltiazem-placebo-controlled"
],
"O": [
"mortality",
"hospitalization",
"progression to Q waves",
"reinfarction by CK-MB criteria",
"angina",
"reinfarction",
"risk of death"
]
}
|
Custom tray application of peroxide gel as an adjunct to scaling and root planing in the treatment of periodontitis : results of a randomized controlled trial after six months . OBJECTIVE Scaling and root planing ( SRP ) is the primary non-surgical treatment for periodontitis , but its effectiveness is limited . Consequently , various adjunctive therapies have been investigated to improve clinical outcome . This study evaluated the clinical effects of one SRP procedure alone or combined with local administration of hydrogen peroxide gel using customized trays for the treatment of subjects with chronic periodontitis over a period of six months . METHODS An examiner-blind clinical trial was conducted among 30 subjects with moderate to advanced periodontitis who were randomized to SRP alone or SRP combined with prescription custom-tray application ( Perio Tray ) of 1.7 % hydrogen peroxide gel ( Perio Gel ) for a period of three months , then extended to six months . Following impressions for the test group , all subjects brushed twice daily with a regular dentifrice and toothbrush for a four-week acclimation phase to standardize oral conditions ( while trays were fabricated ) prior to initiating the treatment phase . SRP was performed three weeks after baseline , and clinical assessments , i.e. , pocket probing depth ( PPD ) and bleeding index ( BI ) , were conducted at baseline and after two , five , 13 , and 26 weeks of peroxide gel applications . Clinical variables were compared by ANCOVA and paired t-tests after each treatment interval . RESULTS A total of 13 test and 15 control subjects completed the original three-month trial , of whom 10 test and 13 control subjects finished the three-month extension . After two weeks of peroxide gel use prior to SRP , mean PPD for the test group significantly decreased from baseline by 0.21 mm and mean BI significantly dropped by 0.14 ; clinical parameters for the control group were unchanged . Two weeks following SRP , mean PPD significantly decreased from baseline by 0.65 mm for the test group and 0.17 mm for the control ; mean BI significantly dropped by 0.17 for the test group and 0.05 for the control . Ten weeks following SRP , mean PPD decreases were 0.77 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.14 for the test group and 0.00 for the control . For subjects who completed the three-month extension ( i.e. , 23 weeks post-SRP ) , mean PPD decreases were 0.72 mm for the test group and 0.13 mm for the control , and mean BI reductions were 0.05 for the test group and 0.01 for the control . Analysis of deeper pockets ( i.e. , > 5 mm at baseline ) showed the same relationship for PPD , but with larger differences between groups . For example , after two weeks of peroxide gel use prior to SRP , mean PPD decreased by 0.48 mm for the test group compared to 0.04 mm for the control . Two weeks after SRP , mean PPD decreased from baseline by 1.40 mm for the test group and 0.60 mm for the control , and 10 weeks after SRP by 1.57 mm for the test group and 0.58 mm for the control . After the extension ( i.e. , 23 weeks post-SRP ) , mean PPD changed from baseline by 1.50 mm for the test group and 0.55 mm for the control . With the exception of BI at 23 weeks post-SRP , all reductions cited above for the test group were statistically significantly different from the control group for both PPD and BI for all comparisons . CONCLUSION When compared with SRP alone , clinical improvements in PPD ( e.g. , -1.0 mm for pockets > 5 mm at baseline ) were maintained for up to six months after SRP with adjunctive use of 1.7 % hydrogen peroxide gel , locally administered using prescription customized trays in the treatment of subjects with moderate to advanced periodontitis .
|
{
"P": [
"periodontitis",
"chronic periodontitis",
"30",
"13 test",
"15 control"
],
"I": [
"peroxide gel",
"scaling",
"and",
"root planing",
"Scaling and root planing ( SRP )",
"SRP",
"hydrogen peroxide gel",
"combined",
"1.7 % hydrogen peroxide gel ( Perio Gel )",
"brushed twice daily with a regular dentifrice and toothbrush"
],
"O": [
"pocket probing depth ( PPD ) and bleeding index ( BI )",
"mean PPD",
"mean BI"
]
}
|
Central 5-HT4 receptor binding as biomarker of serotonergic tonus in humans : a [ 11C ] SB207145 PET study . Identification of a biomarker that can inform on extracellular serotonin ( 5-HT ) levels in the brains of living humans would enable greater understanding of the way brain circuits are modulated by serotonergic neurotransmission . Substantial evidence from studies in animals and humans indicates an inverse relationship between central 5-HT tonus and 5-HT type 4 receptor ( 5-HT4R ) density , suggesting that 5-HT4R receptor density may be a biomarker marker for 5-HT tonus . Here , we investigated whether a 3-week administration of a selective serotonin reuptake inhibitor , expected to increase brain 5-HT levels , is associated with a decline in brain 5-HT4R binding . A total of 35 healthy men were studied in a placebo-controlled , randomized , double-blind study . Participants were assigned to receive 3 weeks of oral dosing with placebo or fluoxetine , 40 mg per day . Brain 5-HT4R binding was quantified at baseline and at follow-up with [ ( 11 ) C ] SB207145 positron emission tomography ( PET ) . Three weeks of intervention with fluoxetine was associated with a 5.2 % reduction in brain 5-HT4R binding ( P=0.017 ) , whereas placebo intervention did not change 5-HT4R binding ( P=0.52 ) . Our findings are consistent with a model , wherein the 5-HT4R density adjusts to changes in the extracellular 5-HT tonus . Our data demonstrate for the first time in humans that the imaging of central 5-HT4R binding may be used as an in vivo biomarker of the central 5-HT tonus .
|
{
"P": [
"humans :",
"living humans"
],
"I": [
"placebo-controlled",
"oral dosing with placebo",
"fluoxetine , 40 mg per day",
"( 11 ) C ] SB207145 positron emission tomography ( PET )"
],
"O": [
"Brain 5-HT4R binding",
"positron emission tomography",
"brain 5-HT4R binding",
"5-HT4R density"
]
}
|
Efficacy and safety of zidovudine and zalcitabine combined with a combination of herbs in the treatment of HIV-infected Thai patients . A randomized double blind placebo controlled trial to determine the efficacy and safety of combined-herbs ( SH ) given with zidovudine ( ZDV ) and zalcitabine ( ddC ) for the treatment of HIV infection in Thai adults was conducted in 3 hospitals in northern Thailand during 2002 to 2003 . The eligible subjects were HIV-infected Thai adults who had never received anti-retrovirals , had a Karnofski Performance Score ( KPS ) of > or = 70 , and had no opportunistic infections . The subjects were randomized to receive either a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and SH 2.5 g three times per day or a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and placebo 2.5 g three times per day for 24 weeks . The main outcome measures were HIV-RNA , CD4 cells , and blood chemistry profiles prior to the treatment and then every 4 weeks for 24 weeks . The baseline characteristics of 60 evaluable subjects , 40 in the SH group and 20 in the placebo group , were not significantly different . HIV RNA at week 4 and thereafter was significantly decreased from the baseline value in both groups ( p < 0.001 ) . However , the decline in HIV RNA in the SH group was significantly more than that in the placebo group . The CD4 cells in the SH group at week 12 and thereafter were significantly increased from the baseline value . Serious adverse events in the two groups were not observed . It is concluded that an addition of SH herbs to two nucleoside reverse transcriptase inhibitors has greater antiviral activity than antiretrovirals only . The SH herbs may be an alternative for the third anti-retroviral agent in the triple drug regimen for the treatment of HIV infected patients in countries with limited resources .
|
{
"P": [
"HIV-infected Thai patients",
"HIV",
"Thai adults",
"HIV-infected",
"adults",
"infections",
"60 evaluable subjects",
"40",
"20"
],
"I": [
"zidovudine and zalcitabine",
"placebo",
"zidovudine",
"zalcitabine",
"anti-retrovirals",
"ZDV",
"ddC",
"SH",
"a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and"
],
"O": [
"Efficacy",
"safety",
"efficacy",
"HIV-RNA , CD4 cells , and blood chemistry profiles",
"HIV RNA",
"CD4 cells",
"Serious adverse events",
"antiviral activity"
]
}
|
Efficacy of topical azithromycin ophthalmic solution 1 % in the treatment of posterior blepharitis . INTRODUCTION Azithromycin , a broad-spectrum antibiotic with potent anti-inflammatory activities , has the potential to effectively treat blepharitis , an inflammatory disease of the eyelid with abnormal eyelid flora as an etiologic determinant . The present study compared the efficacy of topical azithromycin ophthalmic solution 1 % ( AzaSite ; Inspire Pharmaceuticals , Inc , NC , USA ) combined with warm compresses ( azithromycin group ) to warm compresses alone ( compress group ) in patients with posterior blepharitis . METHODS Twenty-one patients diagnosed with posterior blepharitis were randomized in an open-label study to receive either azithromycin plus warm compresses ( 10 patients ) , or compresses alone ( 11 patients ) . All patients were instructed to apply compresses to each eye for 5-10 minutes twice daily for 14 days . Each eye in the azithromycin group also received azithromycin solution ( 1 drop ) twice daily for the first 2 days followed by once daily for the next 12 days . Patients were evaluated at study initiation ( visit 1 ) and at end of treatment ( visit 2 ) for the severity of five clinical signs : eyelid debris , eyelid redness , eyelid swelling , meibomian gland ( MG ) plugging , and the quality of MG secretion . At visit 2 , patients also rated their degree of overall symptomatic relief . RESULTS Twenty patients completed the study . At visit 2 , patients in the azithromycin group demonstrated significant improvements in MG plugging , MG secretions , and eyelid redness as compared with the compress group . In the azithromycin group , MG plugging resolved completely in three patients and MG secretion returned to normal in two patients ; no such results were seen in the compress group . Furthermore , a higher percentage of patients in the azithromycin group rated overall symptomatic relief as excellent or good . Visual acuity measurements and biomicroscopic evaluation revealed no ocular safety issues . CONCLUSION Azithromycin ophthalmic solution in combination with warm compresses provided a significantly greater clinical benefit than warm compresses alone in treating the signs and symptoms of posterior blepharitis .
|
{
"P": [
"posterior blepharitis",
"blepharitis",
"inflammatory disease",
"Twenty-one",
"Twenty"
],
"I": [
"azithromycin",
"Azithromycin",
"warm compresses"
],
"O": [
"Efficacy",
"blepharitis",
"eyelid debris",
"eyelid redness",
"eyelid swelling",
"meibomian gland ( MG ) plugging",
"quality of MG secretion",
"overall symptomatic relief",
"significant improvements",
"MG plugging",
"MG secretions",
"MG secretion returned to normal",
"signs and symptoms of posterior blepharitis"
]
}
|
Single-agent irinotecan or FOLFIRI as second-line chemotherapy for advanced colorectal cancer ; results of a randomised phase II study ( DaVINCI ) and meta-analysis [ corrected ] . BACKGROUND Second-line treatment with irinotecan for advanced or metastatic colorectal cancer prolongs survival . It is uncertain whether irinotecan is better administered with 5-fluorouracil or alone in patients previously treated with a fluoropyrimidine . We compared toxicity ( particularly diarrhoea ) , quality of life , and efficacy of combination chemotherapy and irinotecan in these patients . METHODS In DaVINCI , a randomised phase II trial , patients with advanced colorectal cancer were randomly allocated to : Combination therapy ( FOLFIRI ) , irinotecan ( 180 mg/m ( 2 ) IV over 90 min , day 1 ) , 5-fluorouracil ( 400mg/m ( 2 ) IV bolus and 2400 mg/m ( 2 ) by 46-hour infusion from day 1 ) and folinic acid ( 20mg/m ( 2 ) IV bolus , day 1 ) , 2-weekly ; or Single-agent , irinotecan ( 350 mg/m ( 2 ) IV over 90 min ) , 3-weekly . Toxicity was evaluated every treatment cycle ; QOL and response 6-weekly . Analysis was by intention to treat . The trial , amended from a larger factorial design , was terminated early due to slow recruitment . Results were also combined with other second-line irinotecan trials . FINDINGS We randomised 44 patients to combination and 45 to single agent . Eight patients in the irinotecan arm and 4 in the combination arm had grade 3/4 diarrhoea ( P=0.24 ) . Treatment groups did not differ significantly in overall QOL changes , response rate or progression free or overall-survival . In a systematic review of 29 trials of second-line irinotecan-based treatment , single-agent irinotecan was associated with more diarrhoea and alopecia than the combination but efficacy was similar . INTERPRETATION Combination treatment compared with single-agent irinotecan reduces alopecia and diarrhoea without compromising efficacy on clinical outcomes . Both regimens remain as reasonable treatment options . FUNDING Research grant ( Pfizer ) .
|
{
"P": [],
"I": [
"irinotecan",
"FOLFIRI",
"chemotherapy",
"5-fluorouracil",
"fluoropyrimidine",
"folinic acid",
"irinotecan-based",
"Combination treatment"
],
"O": [
"advanced colorectal cancer",
"survival .",
"Toxicity",
"grade 3/4 diarrhoea",
"overall QOL changes",
"response rate",
"progression free",
"or overall-survival",
"diarrhoea",
"alopecia",
"alopecia and diarrhoea",
"efficacy on clinical outcomes"
]
}
|
A pilot randomised control trial of a parent training intervention for pre-school children with autism . Preliminary findings and methodological challenges . Few attempts have been made to conduct randomised control trials ( RCTs ) of interventions for pre-school children with autism . We report findings of a pilot RCT for a parent training intervention with a focus on the development of joint attention skills and joint action routines . Twenty-four children meeting ICD-10 criteria for childhood autism ( mean age = 23 months ) were identified using the CHAT screen and randomised to the parent training group or to local services only . A follow-up was conducted 12 months later ( mean age = 35 months ) . There was some evidence that the parent training group made more progress in language development than the local services group . However , the present pilot study was compromised by several factors : a reliance on parental report to measure language , non-matching of the groups on initial IQ , and a lack of systematic checking regarding the implementation of the parent training intervention . Furthermore , three parents in the local services group commenced intensive , home-based behavioural intervention during the course of the study . The difficulties encountered in the conduct of RCTs for pre-school children with autism are discussed . Methodological challenges and strategies for future well-designed RCTs for autism interventions are highlighted .
|
{
"P": [
"pre-school children with autism",
"Twenty-four children",
"meeting ICD-10 criteria for childhood autism",
"( mean age = 23 months )"
],
"I": [
"parent training intervention",
"parent training",
"local services",
"home-based behavioural intervention"
],
"O": [
"language development"
]
}
|
Ebeltoft project : baseline data from a five-year randomized , controlled , prospective health promotion study in a Danish population . BACKGROUND There is increasing political pressure on the medical profession to approach welfare diseases , such as coronary heart disease and diabetes , through prevention . General practitioners are required to offer regular health checks to healthy people , in spite of the lack of scientific evidence for the universal need , usefulness and side effects of such an intervention . Randomized controlled trials are needed . AIM A study was carried out to investigate people 's interest in participating in health checks and in discussions about health with their own general practitioner , participants ' health status , the proportion who received health advice following health checks , and the lifestyle goals they set following discussion with their general practitioner . This study reports the baseline data from a five-year randomized , controlled , prospective , population-based study in general practices in Ebeltoft , Denmark . METHOD All general practitioners from the four practices in Ebeltoft and a random sample of 2000 people aged between 30 and 50 years were invited to participate . Participants were randomly divided into three groups -- one control group and two intervention groups . One intervention group were given a health check which included being screened for cardiovascular risk factors , lung and liver function , fitness , sight and hearing and an optional test for the human immunodeficiency virus ( HIV ) ; this group received written feedback from the general practitioner . The other intervention group were also given a health check and written feedback ; in addition , they were given the opportunity to attend their general practitioner to discuss preventive health . RESULTS A total of 1370 people participated in the study ( 69 % response rate ) . Health advice was given to 76 % of 905 participants following health checks . Almost all of the 456 participants ( 96 % ) who were offered the opportunity of discussing their health with their general practitioner took up the offer ; 64 % of the 456 participants reported that they had decided to undertake lifestyle changes . Eleven of those who discussed their health with the doctor were referred to a specialist ( 2 % ) . CONCLUSION There was considerable interest in participating in health promotion . Three out of four of those having a health check were given health advice . Two out of three of those offered a health talk with the general practitioner appeared willing to make relevant lifestyle changes . Long-term follow up is needed to determine effects and side effects of health checks and health talks .
|
{
"P": [
"healthy",
"2000",
"30 and 50",
"1370",
"456",
"Eleven"
],
"I": [
"regular health checks",
"health checks",
"control",
"health check which included being screened for cardiovascular risk factors , lung and liver function , fitness , sight and hearing and an optional test for the human immunodeficiency virus ( HIV ) ; this group received written feedback from the general practitioner .",
"health check and",
"written feedback",
"; in addition , they were given the opportunity to attend their general practitioner to discuss preventive health ."
],
"O": [
"Health advice",
"undertake lifestyle changes",
"referred to a specialist"
]
}
|
Acute cardiac effects of nicotine in healthy young adults . BACKGROUND Nicotine is known to have many physiologic effects . The influence of nicotine delivered in chewing gum upon cardiac hemodynamics and conduction has not been well-characterized . METHODS We studied the effects of nicotine in nonsmoking adults ( 6 male , 5 female ; ages 23-36 years ) using a double-blind , randomized , cross-over study . Subjects chewed nicotine gum ( 4 mg ) or placebo . After 20 minutes ( approximate time to peak nicotine levels ) , echocardiograms and signal-averaged electrocardiograms ( SAECG ) were obtained . After 40 minutes , subjects were again given nicotine gum or placebo in cross-over fashion . Standard echocardiographic measurements were made from two-dimensional images . We then calculated end-systolic wall stress ( ESWS ) , shortening fraction ( SF ) , systemic vascular resistance ( SVR ) , velocity for circumferential fiber shortening corrected for heart rate ( Vcfc ) , stroke volume , and cardiac output . P wave and QRS duration were measured from SAECG . RESULTS Significant differences ( P < 0.05 ) from control or placebo were found for ESWS , mean blood pressure , cardiac output , SVR , heart rate , and P wave duration . No significant changes were seen in left ventricular ejection time ( LVET ) , LV dimensions , SF , contractility ( Vcfc ) , or QRS duration . CONCLUSIONS These results suggest that nicotine chewing gum increases afterload and cardiac output . Cardiac contractility does not change acutely in response to nicotine gum . Heart rate and P wave duration are increased by chewing nicotine gum .
|
{
"P": [],
"I": [
"nicotine",
"nicotine gum ( 4 mg )",
"placebo",
"echocardiograms and signal-averaged electrocardiograms",
"nicotine gum"
],
"O": [
"end-systolic wall stress ( ESWS ) , shortening fraction ( SF ) , systemic vascular resistance ( SVR ) , velocity for circumferential fiber shortening corrected for heart rate ( Vcfc ) , stroke volume , and cardiac output . P wave and QRS duration",
"ESWS",
"blood pressure",
"cardiac output",
"SVR",
"heart rate",
"P wave duration",
"left ventricular ejection time ( LVET ) , LV dimensions",
"SF",
"contractility ( Vcfc )",
"QRS duration",
"afterload and cardiac output . Cardiac contractility",
"Heart rate"
]
}
|
Carvedilol increases plasma vascular endothelial growth factor ( VEGF ) in patients with chronic heart failure .
|
{
"P": [
"patients with chronic heart failure"
],
"I": [
"Carvedilol"
],
"O": [
"plasma vascular endothelial growth factor ( VEGF )"
]
}
|
JobTIPS : a transition to employment program for individuals with autism spectrum disorders . This study evaluated the effectiveness of an internet accessed training program that included Theory of Mind-based guidance , video models , visual supports , and virtual reality practice sessions in teaching appropriate job interview skills to individuals with high functioning Autism Spectrum Disorders . In a randomized study , twenty-two youth , ages 16-19 , were evaluated during two employment interviews . Half received a training intervention following the initial interview and the half who served as a contrast group did not . Their performance pre and post intervention was assessed by four independent raters using a scale that included evaluation of both Content and Delivery . Results suggest that youth who completed the JobTIPS employment program demonstrated significantly more effective verbal content skills than those who did not .
|
{
"P": [],
"I": [
"internet accessed training program"
],
"O": [
"effectiveness",
"internet accessed training program",
"Content and Delivery",
"effective verbal content skills"
]
}
|
Scaling clinical judgments of symptom pathology by means of the psychophysiological method of magnitude estimation . Summing scores across heterogeneous symptom items without consideration of their differing psychopathological significance has been criticized as producing an inadequate picture of an individual 's clinical status . The purpose of this study was to derive symptom item weights representing clinically judged seriousness of each symptom through the application of Steven 's psychophysical method of magnitude estimation . A nationwide sample of 129 clinicians rated the pathological significance of 221 symptom items in a design such that every rater rated 121 items , 21 of which were rated by all raters and 100 of which were rated only by the A or B subgroup to which each rater was randomly assigned . Each item was rated as to the seriousness of the pathology it would represent if manifested by either a boy child , girl child , boy adolescent , or girl adolescent , with one-fourth of the raters assigned to each condition . The results of 211 two-way analyses of variance revealed that age and age and sex in interaction , but not sex alone , significantly influenced the clinical ratings . The resulting magnitude estimation ratings of symptom pathology ranged from 1.0 to 9.9 . They were demonstrated to have satisfactoy reliability and convergent validity and to have the psychophysical characteristics of a prothetic continuum .
|
{
"P": [],
"I": [
"Steven 's psychophysical method of magnitude estimation ."
],
"O": [
"age and sex",
"magnitude estimation ratings of symptom pathology"
]
}
|
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