target
stringclasses 5
values | description
stringlengths 2
1.81k
⌀ | description_cln
stringlengths 2
1.77k
⌀ |
|---|---|---|
RESULTS | There was no significant difference in response for the same parameters among subjects classified as LDL pattern A or B with the exception of significantly greater ( p = 0.01 ) reduction in mean peak particle diameter in pattern A subjects treated with either garlic or placebo . | There was no significant difference in response for the same parameters among subjects classified as LDL pattern A or B with the exception of significantly greater (p = 0. 01) reduction in mean peak particle diameter in pattern A subjects treated with either garlic or placebo. |
RESULTS | There was no significant change in LDL subclass distribution . | There was no significant change in LDL subclass distribution. |
CONCLUSIONS | This investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further , that it has no impact on HDL subclasses , Lp ( a ) , apolipoprotein B , postprandial triglycerides or LDL subclass distribution . | This investigation confirms that garlic therapy has no effect on major plasma lipoproteins and further, that it has no impact on HDL subclasses, Lp (a), apolipoprotein B, postprandial triglycerides or LDL subclass distribution. |
CONCLUSIONS | Garlic may have a greater effect on LDL particle diameter in LDL pattern A compared with pattern B subjects . | Garlic may have a greater effect on LDL particle diameter in LDL pattern A compared with pattern B subjects. |
CONCLUSIONS | This difference was not reflected in other plasma lipid measurements . | This difference was not reflected in other plasma lipid measurements. |
BACKGROUND | Ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in 5 % of colonoscopy activity , and the need for training is undefined . | Ileoscopy is the criterion standard for mucosal lesions of terminal ileum but is performed in 5 % of colonoscopy activity, and the need for training is undefined. |
OBJECTIVE | To assess the learning curve and skill-keeping line of ileoscopy . | To assess the learning curve and skill-keeping line of ileoscopy. |
METHODS | Prospective randomized study . | Prospective randomized study. |
METHODS | Single GI endoscopy unit . | Single GI endoscopy unit. |
METHODS | Adult outpatients referred for colonoscopy . | Adult outpatients referred for colonoscopy. |
METHODS | Patient randomization to ileocolonoscopy by trainees and seniors . | Patient randomization to ileocolonoscopy by trainees and seniors. |
METHODS | Ileoscopy skill was divided into the following : ileocecal valve ( ICV ) intubation ( success rate , time ) and ileal exploration ( length , time ) . | Ileoscopy skill was divided into the following : ileocecal valve (ICV) intubation (success rate, time) and ileal exploration (length, time). |
METHODS | Consecutive blocks of 10 procedures were used to calculate the learning curve and the skill-keeping line . | Consecutive blocks of 10 procedures were used to calculate the learning curve and the skill-keeping line. |
METHODS | Variables considered to influence ICV intubation were the following : endoscopist experience , ICV morphology , patient age , gender , body mass index , diverticular disease , and preceding abdominal/pelvic surgery . | Variables considered to influence ICV intubation were the following : endoscopist experience, ICV morphology, patient age, gender, body mass index, diverticular disease, and preceding abdominal/pelvic surgery. |
RESULTS | Learning curve showed that competency in ICV intubation ( 80 % success rate ) and ileal exploration ( 16 cm ) was achieved after 50 procedures . | Learning curve showed that competency in ICV intubation (80 % success rate) and ileal exploration (16 cm) was achieved after 50 procedures. |
RESULTS | The skill-keeping line showed that ileoscopy was easy ( 97 % success rate ) , fast ( 1 minute ) , and well accepted up to 45 cm of the ileum . | The skill-keeping line showed that ileoscopy was easy (97 % success rate), fast (1 minute), and well accepted up to 45 cm of the ileum. |
RESULTS | Thin-lipped and volcanic ICV are the most difficult and easiest to intubate , respectively . | Thin-lipped and volcanic ICV are the most difficult and easiest to intubate, respectively. |
RESULTS | Crohn 's disease and adenomas of the proximal edge of ICV were diagnosed in 2.2 % . | Crohn 's disease and adenomas of the proximal edge of ICV were diagnosed in 2. 2 %. |
CONCLUSIONS | Training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing ICV intubation to maintain and increase their skill . | Training in ileoscopy is recommended to achieve competency, and endoscopists should consider practicing ICV intubation to maintain and increase their skill. |
CONCLUSIONS | Ileoscopy can be difficult when the ICV is thin lipped or single bulged , and easy when it has a volcanic morphology . | Ileoscopy can be difficult when the ICV is thin lipped or single bulged, and easy when it has a volcanic morphology. |
OBJECTIVE | To estimate minimally important differences ( MIDs ) in scores for the modified Rodnan Skin Score ( mRSS ) and Health Assessment Questionnaire-Disability Index ( HAQ-DI ) in a clinical trial on diffuse systemic sclerosis ( SSc ) . | To estimate minimally important differences (MIDs) in scores for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire-Disability Index (HAQ-DI) in a clinical trial on diffuse systemic sclerosis (SSc). |
METHODS | 134 people participated in a 2-year , double-blind , randomised clinical trial comparing efficacy of low-dose and high-dose D-penicillamine in diffuse SSc . | 134 people participated in a 2-year, double-blind, randomised clinical trial comparing efficacy of low-dose and high-dose D-penicillamine in diffuse SSc. |
METHODS | At 6 , 12 , 18 and 24 months , the investigator was asked to rate the change in the patient 's health since entering the study : markedly worsened , moderately worsened , slightly worsened , unchanged , slightly improved , moderately improved or markedly improved . | At 6, 12, 18 and 24 months, the investigator was asked to rate the change in the patient 's health since entering the study : markedly worsened, moderately worsened, slightly worsened, unchanged, slightly improved, moderately improved or markedly improved. |
METHODS | Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved . | Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved. |
RESULTS | The MID estimates for the mRSS improvement ranged from 3.2 to 5.3 ( 0.40-0 .66 effect size ) and for the HAQ-DI from 0.10 to 0.14 ( 0.15-0 .21 effect size ) . | The MID estimates for the mRSS improvement ranged from 3. 2 to 5. 3 (0. 40-0. 66 effect size) and for the HAQ-DI from 0. 10 to 0. 14 (0. 15-0. 21 effect size). |
RESULTS | Patients who were rated to improve more than slightly were found to improve by 6.9-14 .2 ( 0.86-1 .77 effect size ) on the mRSS and 0.21-0 .55 ( 0.32-0 .83 effect size ) on the HAQ-DI score . | Patients who were rated to improve more than slightly were found to improve by 6. 9-14. 2 (0. 86-1. 77 effect size) on the mRSS and 0. 21-0. 55 (0. 32-0. 83 effect size) on the HAQ-DI score. |
CONCLUSIONS | MID estimates are provided for improvement in the mRSS and HAQ-DI scores , which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc . | MID estimates are provided for improvement in the mRSS and HAQ-DI scores, which can help in interpreting clinical trials on patients with SSc and be used for sample size calculation for future clinical trials on diffuse SSc. |
OBJECTIVE | Long-term pharmacological glucocorticoid ( GC ) therapy leads to skeletal muscle atrophy and weakness . | Long-term pharmacological glucocorticoid (GC) therapy leads to skeletal muscle atrophy and weakness. |
OBJECTIVE | The objective of this study was to investigate whether short-term treatment with GH and testosterone ( T ) can increase lean mass without major impairment of glucose homoeostasis in patients on GC therapy . | The objective of this study was to investigate whether short-term treatment with GH and testosterone (T) can increase lean mass without major impairment of glucose homoeostasis in patients on GC therapy. |
METHODS | This was a prospective , open-label , randomised , crossover study . | This was a prospective, open-label, randomised, crossover study. |
METHODS | Twelve men ( age 746 years ) on chronic GC treatment participated . | Twelve men (age 746 years) on chronic GC treatment participated. |
METHODS | The effects of 2 weeks ' treatment with GH , testosterone and the combination of both on lean body mass ( LBM ) , appendicular skeletal muscle mass ( ASMM ) , extracellular water ( ECW ) , body cell mass ( BCM ) and plasma glucose concentrations were investigated . | The effects of 2 weeks'treatment with GH, testosterone and the combination of both on lean body mass (LBM), appendicular skeletal muscle mass (ASMM), extracellular water (ECW), body cell mass (BCM) and plasma glucose concentrations were investigated. |
RESULTS | LBM increased significantly after GH ( 1.71.4 kg ; P = 0.007 ) and GH + testosterone ( 2.41.1 kg ; P = 0.003 ) , but not testosterone alone . | LBM increased significantly after GH (1. 71. 4 kg ; P = 0. 007) and GH + testosterone (2. 41. 1 kg ; P = 0. 003), but not testosterone alone. |
RESULTS | ASMM increased after all three treatment periods ; by 1.00.8 kg after GH ( P = 0.005 ) , 1.70.4 kg after GH + testosterone ( P = 0.002 ) and 0.81.0 kg after testosterone ( P = 0.018 ) . | ASMM increased after all three treatment periods ; by 1. 00. 8 kg after GH (P = 0. 005), 1. 70. 4 kg after GH + testosterone (P = 0. 002) and 0. 81. 0 kg after testosterone (P = 0. 018). |
RESULTS | The increase in ASMM was larger with combined treatment than either GH or testosterone alone ( P < 0.05 ) . | The increase in ASMM was larger with combined treatment than either GH or testosterone alone (P < 0. 05). |
RESULTS | ECW increased significantly after GH + testosterone by 1.52.6 l ( P = 0.038 ) but not after GH or testosterone alone . | ECW increased significantly after GH + testosterone by 1. 52. 6 l (P = 0. 038) but not after GH or testosterone alone. |
RESULTS | BCM increased slightly after single and combined treatments , but the changes were not significant . | BCM increased slightly after single and combined treatments, but the changes were not significant. |
RESULTS | Fasting glucose increased significantly after GH ( 0.40.4 mmol/l , P = 0.006 ) while both fasting ( 0.20.3 mmol/l , P = 0.045 ) and post glucose-load ( 1.82.3 mmol/l , P = 0.023 ) plasma glucose concentrations increased after GH + testosterone . | Fasting glucose increased significantly after GH (0. 40. 4 mmol/l, P = 0. 006) while both fasting (0. 20. 3 mmol/l, P = 0. 045) and post glucose-load (1. 82. 3 mmol/l, P = 0. 023) plasma glucose concentrations increased after GH + testosterone. |
CONCLUSIONS | GH and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose GC treatment . | GH and testosterone induce favourable and additive body compositional changes in men on chronic, low-dose GC treatment. |
CONCLUSIONS | In the doses used , combination therapy increases fasting and postprandial glucose concentration . | In the doses used, combination therapy increases fasting and postprandial glucose concentration. |
BACKGROUND | Utilization rates ( URs ) for implantable cardioverter-defibrillators ( ICDs ) for primary prevention of sudden cardiac death ( PPSCD ) are lacking in the community . | Utilization rates (URs) for implantable cardioverter-defibrillators (ICDs) for primary prevention of sudden cardiac death (PPSCD) are lacking in the community. |
OBJECTIVE | The purpose of this study was to establish the ICD UR in central Indiana . | The purpose of this study was to establish the ICD UR in central Indiana. |
METHODS | A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction ( EF ) 0.35 . | A query run on 2 hospitals in a health information exchange database in Indianapolis identified patients between 2011 and 2012 with left ventricular ejection fraction (EF) 0. 35. |
METHODS | ICD eligibility and utilization were determined from chart review . | ICD eligibility and utilization were determined from chart review. |
RESULTS | We identified 1863 patients with at least 1 low EF study . | We identified 1863 patients with at least 1 low EF study. |
RESULTS | Two cohorts were analyzed : 1672 patients without and 191 patients with International Classification of Diseases , Ninth Revision , Clinical Modification procedure code 37.94 for ICD placement . | Two cohorts were analyzed : 1672 patients without and 191 patients with International Classification of Diseases, Ninth Revision, Clinical Modification procedure code 37. 94 for ICD placement. |
RESULTS | We manually reviewed a stratified ( by hospital ) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 ( 16 % ) had no ICD but had class I indications for ICD . | We manually reviewed a stratified (by hospital) random sample of 300 patients from the no-ICD procedure code cohort and found that 48 (16 %) had no ICD but had class I indications for ICD. |
RESULTS | Eight of 300 ( 2.7 % ) actually had ICD implantation for PPSCD . | Eight of 300 (2. 7 %) actually had ICD implantation for PPSCD. |
RESULTS | Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD . | Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD. |
RESULTS | The ICD UR ( ratio between patients with ICD for PPSCD and all with indication ) was 38 % overall ( 95 % confidence interval [ CI ] 28 % -49 % ) . | The ICD UR (ratio between patients with ICD for PPSCD and all with indication) was 38 % overall (95 % confidence interval [CI] 28 % -49 %). |
RESULTS | URs were 48 % for males ( 95 % CI 34 % -61 % ) , 21 % for females ( 95 % CI 16 % -26 % , P = .0002 vs males ) , 40 % for whites ( 95 % CI 27 % -53 % ) , and 37 % for blacks ( 95 % CI 28 % -46 % , P = .66 vs whites ) . | URs were 48 % for males (95 % CI 34 % -61 %), 21 % for females (95 % CI 16 % -26 %, P =. 0002 vs males), 40 % for whites (95 % CI 27 % -53 %), and 37 % for blacks (95 % CI 28 % -46 %, P =. 66 vs whites). |
CONCLUSIONS | ICD UR is 38 % among patients meeting class I indications , suggesting further opportunities for improving guideline compliance . | ICD UR is 38 % among patients meeting class I indications, suggesting further opportunities for improving guideline compliance. |
CONCLUSIONS | This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review . | This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review. |
OBJECTIVE | The study 's purpose was to analyze the effects of exercise training on exercise tolerance and left ventricular systolic function and structure in heart failure patients with preserved , mild , and moderate to severe reduction of left ventricular ejection fraction ( LVEF ) . | The study 's purpose was to analyze the effects of exercise training on exercise tolerance and left ventricular systolic function and structure in heart failure patients with preserved, mild, and moderate to severe reduction of left ventricular ejection fraction (LVEF). |
METHODS | Ninety-eight patients with moderate to severe ( n = 34 ) , mild ( n = 33 ) , and preserved ( n = 31 ) LVEF were randomly assigned to exercise training plus usual care ( n = 65 ) or usual care alone ( n = 33 ) in a randomization ratio of 2:1 . | Ninety-eight patients with moderate to severe (n = 34), mild (n = 33), and preserved (n = 31) LVEF were randomly assigned to exercise training plus usual care (n = 65) or usual care alone (n = 33) in a randomization ratio of 2:1. |
METHODS | Left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention . | Left ventricular function, left ventricular dimensions, and exercise tolerance were assessed before and after each intervention. |
RESULTS | Exercise tolerance and LVEF increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone . | Exercise tolerance and LVEF increased with exercise training in all patient groups, whereas they remained unchanged after usual care alone. |
RESULTS | Exercise training increased the mean ratio of early to late mitral inflow velocities ( E/A ratio ) and decreased deceleration time ( DT ) of early filling in patients with mild and preserved LVEF . | Exercise training increased the mean ratio of early to late mitral inflow velocities (E/A ratio) and decreased deceleration time (DT) of early filling in patients with mild and preserved LVEF. |
RESULTS | In patients with moderate to severe systolic dysfunction and advanced diastolic dysfunction ( DT < 160 ms ) , exercise training decreased E/A ratio and increased DT , both of which were unchanged after usual care alone . | In patients with moderate to severe systolic dysfunction and advanced diastolic dysfunction (DT < 160 ms), exercise training decreased E/A ratio and increased DT, both of which were unchanged after usual care alone. |
RESULTS | In the remaining patients ( DT > 160 ms ) , exercise training also improved mitral inflow patterns . | In the remaining patients (DT > 160 ms), exercise training also improved mitral inflow patterns. |
RESULTS | Exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of LVEF but not in patients with preserved LVEF . | Exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of LVEF but not in patients with preserved LVEF. |
CONCLUSIONS | These results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction . | These results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction. |
OBJECTIVE | To investigate the feasibility of implementing a Sleep Education Program ( SEP ) for improving sleep in adult family home ( AFH ) residents with dementia , and the relative efficacy of SEP compared with usual care control in a pilot randomized controlled trial . | To investigate the feasibility of implementing a Sleep Education Program (SEP) for improving sleep in adult family home (AFH) residents with dementia, and the relative efficacy of SEP compared with usual care control in a pilot randomized controlled trial. |
METHODS | Thirty-seven AFH staff-caregivers and 47 residents with comorbid dementia and sleep disturbances . | Thirty-seven AFH staff-caregivers and 47 residents with comorbid dementia and sleep disturbances. |
METHODS | SEP consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans . | SEP consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans. |
METHODS | Treatment fidelity to the SEP was assessed following the National Institutes of Health ( NIH ) Behavior Change Consortium model utilizing trainer observations and staff-caregiver reports . | Treatment fidelity to the SEP was assessed following the National Institutes of Health (NIH) Behavior Change Consortium model utilizing trainer observations and staff-caregiver reports. |
METHODS | Resident sleep was assessed by wrist actigraphy at baseline , 1-month posttreatment , and 6-month follow-up . | Resident sleep was assessed by wrist actigraphy at baseline, 1-month posttreatment, and 6-month follow-up. |
METHODS | Caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected . | Caregiver reports of resident daytime sleepiness, depression, and disruptive behaviors were also collected. |
RESULTS | Each key area of treatment fidelity ( SEP delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes . | Each key area of treatment fidelity (SEP delivery, receipt, enactment) was identified, measured, and yielded significant outcomes. |
RESULTS | Staff-caregivers learned how to identify sleep scheduling , daily activity , and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors . | Staff-caregivers learned how to identify sleep scheduling, daily activity, and environmental factors that could contribute to nocturnal disturbances and developed and implemented strategies for modifying these factors. |
RESULTS | SEP decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the 6-month follow-up period compared with the control condition . | SEP decreased the frequency and disturbance level of target resident nocturnal behaviors and improved actigraphically measured sleep percent and total sleep time over the 6-month follow-up period compared with the control condition. |
CONCLUSIONS | Results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with AFH residents with dementia . | Results suggest behavioral interventions to improve sleep are feasible to implement in adult family homes and merit further investigation as a promising intervention for use with AFH residents with dementia. |
OBJECTIVE | To compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type 2 diabetes . | To compare the effects of prandial insulin therapy focusing on postprandial glucose control vs. basal insulin therapy focusing on fasting glucose control in patients with type 2 diabetes. |
METHODS | This was an open-label , randomized , parallel , three-arm multicenter trial in patients with type 2 diabetes starting insulin treatment . | This was an open-label, randomized, parallel, three-arm multicenter trial in patients with type 2 diabetes starting insulin treatment. |
METHODS | Patients ( n = 159 ) were randomly assigned to 24-week treatment with 3x daily insulin lispro , 3x daily lispro mid mixture ( MidMix ; 50 % lispro , 50 % protaminated lispro ) , or 1x daily insulin glargine ; oral antihyperglycemic agents were discontinued . | Patients (n = 159) were randomly assigned to 24-week treatment with 3x daily insulin lispro, 3x daily lispro mid mixture (MidMix ; 50 % lispro, 50 % protaminated lispro), or 1x daily insulin glargine ; oral antihyperglycemic agents were discontinued. |
METHODS | Primary end point was the postprandial glucose excursion 2 h after breakfast at the end of study . | Primary end point was the postprandial glucose excursion 2 h after breakfast at the end of study. |
METHODS | Secondary outcomes included HbA1c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction . | Secondary outcomes included HbA1c, self-monitored blood glucose profiles, hypoglycemic episodes, body weight, and patient satisfaction. |
RESULTS | At the end of study , glucose excursions 2 h after breakfast were significantly lower with lispro and MidMix than with glargine ( P < .001 for each vs. glargine ) : lispro , -0.6 + / -2.0 mmol/l ; MidMix , +0.8 + / -2.4 mmol/l ; glargine , +2.5 + / -2.4 mmol/l . | At the end of study, glucose excursions 2 h after breakfast were significantly lower with lispro and MidMix than with glargine (P <. 001 for each vs. glargine) : lispro, -0. 6 + / -2. 0 mmol/l ; MidMix, +0. 8 + / -2. 4 mmol/l ; glargine, +2. 5 + / -2. 4 mmol/l. |
RESULTS | Fasting glucose decreases were significantly greater with glargine ( -2.6 + / -2.4 mmol/l ) than with lispro or MidMix ( -0.9 + / -2.2 mmol/l ; +0.9 + / -1.8 mmol/l ) . | Fasting glucose decreases were significantly greater with glargine (-2. 6 + / -2. 4 mmol/l) than with lispro or MidMix (-0. 9 + / -2. 2 mmol/l ; +0. 9 + / -1. 8 mmol/l). |
RESULTS | Nevertheless , HbA1c decreased by 1.1 % ( lispro ) and 1.2 % ( MidMix ) , vs. 0.3 % with glargine . | Nevertheless, HbA1c decreased by 1. 1 % (lispro) and 1. 2 % (MidMix), vs. 0. 3 % with glargine. |
RESULTS | Hypoglycemic episodes were rare with 1-1 .5 self-reported episodes per 100 patient-days . | Hypoglycemic episodes were rare with 1-1. 5 self-reported episodes per 100 patient-days. |
CONCLUSIONS | In patients with type 2 diabetes starting insulin , 3x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine , in spite suboptimal fasting glucose levels , which targets fasting glucose values . | In patients with type 2 diabetes starting insulin, 3x daily prandial treatment with a rapid-acting analog focusing on postprandial glucose values enabled better control of postprandial and circadian blood glucose profiles than once-daily glargine, in spite suboptimal fasting glucose levels, which targets fasting glucose values. |
CONCLUSIONS | These results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving HbA1c targets . | These results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving HbA1c targets. |
BACKGROUND | Female sex workers who inject drugs ( FSW-IDUs ) are at risk of acquiring HIV , sexually transmitted infections ( STI ) and blood-borne infections through unprotected sex and sharing injection equipment . | Female sex workers who inject drugs (FSW-IDUs) are at risk of acquiring HIV, sexually transmitted infections (STI) and blood-borne infections through unprotected sex and sharing injection equipment. |
BACKGROUND | We conducted a 22 factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among FSW-IDUs in Tijuana and Ciudad Juarez , Mexico . | We conducted a 22 factorial randomized controlled trial to evaluate combination interventions to simultaneously reduce sexual and injection risks among FSW-IDUs in Tijuana and Ciudad Juarez, Mexico. |
METHODS | FSW-IDUs 18 years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule , blinding interviewer/counselors to assignment . | FSW-IDUs 18 years reporting sharing injection equipment and unprotected sex with clients within the last month were randomized to one of four conditions based on an a priori randomization schedule, blinding interviewer/counselors to assignment. |
METHODS | Due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information . | Due to the extreme vulnerability of this population, we did not include a control group that would deny some women access to preventive information. |
METHODS | All women received similar information regardless of group allocation ; the difference was in the way the information was delivered and the extent to which women had an interactive role . | All women received similar information regardless of group allocation ; the difference was in the way the information was delivered and the extent to which women had an interactive role. |
METHODS | Each condition was a single 60-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention . | Each condition was a single 60-minute session, including either an interactive or didactic version of an injection risk intervention and sexual risk intervention. |
METHODS | Women underwent interviewer-administered surveys and testing for HIV , syphilis , gonorrhea , Chlamydia , and Trichomonas at baseline and quarterly for 12 months . | Women underwent interviewer-administered surveys and testing for HIV, syphilis, gonorrhea, Chlamydia, and Trichomonas at baseline and quarterly for 12 months. |
METHODS | Combined HIV/STI incidence will be the primary outcome . | Combined HIV/STI incidence will be the primary outcome. |
METHODS | Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients . | Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients. |
CONCLUSIONS | Of 1,132 women , 548 ( 48.4 % ) were excluded ( 88.9 % were ineligible ; 11.1 % refused to participate or did not return ) ; 584 eligible women enrolled ( 284 in Tijuana ; 300 in Ciudad Juarez ) . | Of 1, 132 women, 548 (48. 4 %) were excluded (88. 9 % were ineligible ; 11. 1 % refused to participate or did not return) ; 584 eligible women enrolled (284 in Tijuana ; 300 in Ciudad Juarez). |
CONCLUSIONS | All 584 participants completed the baseline interview , provided biological samples and were randomized to one of the four groups . | All 584 participants completed the baseline interview, provided biological samples and were randomized to one of the four groups. |
CONCLUSIONS | During follow-up , 17 participants ( 2.9 % ) were lost to follow-up , of whom 10 ( 58.8 % ) had died , leaving 567 participants for analysis . | During follow-up, 17 participants (2. 9 %) were lost to follow-up, of whom 10 (58. 8 %) had died, leaving 567 participants for analysis. |
CONCLUSIONS | This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs . | This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs. |
CONCLUSIONS | The factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks , which will have direct , tangible policy implications for Mexico and potentially other resource-poor countries . | The factorial design will permit analysis to determine whether the combination of the two interactive interventions and/or its respective components are effective in reducing injection and/or sexual risks, which will have direct, tangible policy implications for Mexico and potentially other resource-poor countries. |
BACKGROUND | NCT00840658 . | NCT00840658. |
OBJECTIVE | To compare oral risperidone and intramuscular ( IM ) haloperidol , both in combination with IM lorazepam , in the management of acute agitation and psychosis in the medical emergency department . | To compare oral risperidone and intramuscular (IM) haloperidol, both in combination with IM lorazepam, in the management of acute agitation and psychosis in the medical emergency department. |
METHODS | In this prospective , randomized , placebo-controlled , double-blind study of 30 patients presenting to the emergency department with acute agitation and/or psychosis , three groups of 10 patients received oral and IM medications : 1 ) 2 mg oral risperidone and 2 mg IM lorazepam ; 2 ) 5 mg oral haloperidol and 2 mg IM lorazepam ; 3 ) oral placebo and 2 mg IM lorazepam . | In this prospective, randomized, placebo-controlled, double-blind study of 30 patients presenting to the emergency department with acute agitation and/or psychosis, three groups of 10 patients received oral and IM medications : 1) 2 mg oral risperidone and 2 mg IM lorazepam ; 2) 5 mg oral haloperidol and 2 mg IM lorazepam ; 3) oral placebo and 2 mg IM lorazepam. |