pietrolesci/pubmed-200k-rct · Datasets at Hugging Face

labels class label 5 classes	text stringlengths 3 1.81k	uid int64 0 2.21M
4RESULTS	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 .	300
4RESULTS	There was no significant change in LDL subclass distribution .	301
1CONCLUSIONS	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 .	302
1CONCLUSIONS	Garlic may have a greater effect on LDL particle diameter in LDL pattern A compared with pattern B subjects .	303
1CONCLUSIONS	This difference was not reflected in other plasma lipid measurements .	304
0BACKGROUND	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 .	305
3OBJECTIVE	To assess the learning curve and skill-keeping line of ileoscopy .	306
2METHODS	Prospective randomized study .	307
2METHODS	Single GI endoscopy unit .	308
2METHODS	Adult outpatients referred for colonoscopy .	309
2METHODS	Patient randomization to ileocolonoscopy by trainees and seniors .	310
2METHODS	Ileoscopy skill was divided into the following : ileocecal valve ( ICV ) intubation ( success rate , time ) and ileal exploration ( length , time ) .	311
2METHODS	Consecutive blocks of 10 procedures were used to calculate the learning curve and the skill-keeping line .	312
2METHODS	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 .	313
4RESULTS	Learning curve showed that competency in ICV intubation ( 80 % success rate ) and ileal exploration ( 16 cm ) was achieved after 50 procedures .	314
4RESULTS	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 .	315
4RESULTS	Thin-lipped and volcanic ICV are the most difficult and easiest to intubate , respectively .	316
4RESULTS	Crohn 's disease and adenomas of the proximal edge of ICV were diagnosed in 2.2 % .	317
1CONCLUSIONS	Training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing ICV intubation to maintain and increase their skill .	318
1CONCLUSIONS	Ileoscopy can be difficult when the ICV is thin lipped or single bulged , and easy when it has a volcanic morphology .	319
3OBJECTIVE	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 ) .	320
2METHODS	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 .	321
2METHODS	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 .	322
2METHODS	Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved .	323
4RESULTS	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 ) .	324
4RESULTS	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 .	325
1CONCLUSIONS	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 .	326
3OBJECTIVE	Long-term pharmacological glucocorticoid ( GC ) therapy leads to skeletal muscle atrophy and weakness .	327
3OBJECTIVE	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 .	328
2METHODS	This was a prospective , open-label , randomised , crossover study .	329
2METHODS	Twelve men ( age 746 years ) on chronic GC treatment participated .	330
2METHODS	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 .	331
4RESULTS	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 .	332
4RESULTS	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 ) .	333
4RESULTS	The increase in ASMM was larger with combined treatment than either GH or testosterone alone ( P < 0.05 ) .	334
4RESULTS	ECW increased significantly after GH + testosterone by 1.52.6 l ( P = 0.038 ) but not after GH or testosterone alone .	335
4RESULTS	BCM increased slightly after single and combined treatments , but the changes were not significant .	336
4RESULTS	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 .	337
1CONCLUSIONS	GH and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose GC treatment .	338
1CONCLUSIONS	In the doses used , combination therapy increases fasting and postprandial glucose concentration .	339
0BACKGROUND	Utilization rates ( URs ) for implantable cardioverter-defibrillators ( ICDs ) for primary prevention of sudden cardiac death ( PPSCD ) are lacking in the community .	340
3OBJECTIVE	The purpose of this study was to establish the ICD UR in central Indiana .	341
2METHODS	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 .	342
2METHODS	ICD eligibility and utilization were determined from chart review .	343
4RESULTS	We identified 1863 patients with at least 1 low EF study .	344
4RESULTS	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 .	345
4RESULTS	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 .	346
4RESULTS	Eight of 300 ( 2.7 % ) actually had ICD implantation for PPSCD .	347
4RESULTS	Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD .	348
4RESULTS	The ICD UR ( ratio between patients with ICD for PPSCD and all with indication ) was 38 % overall ( 95 % confidence interval [ CI ] 28 % -49 % ) .	349
4RESULTS	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 ) .	350
1CONCLUSIONS	ICD UR is 38 % among patients meeting class I indications , suggesting further opportunities for improving guideline compliance .	351
1CONCLUSIONS	This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review .	352
3OBJECTIVE	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 ) .	353
2METHODS	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 .	354
2METHODS	Left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention .	355
4RESULTS	Exercise tolerance and LVEF increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone .	356
4RESULTS	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 .	357
4RESULTS	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 .	358
4RESULTS	In the remaining patients ( DT > 160 ms ) , exercise training also improved mitral inflow patterns .	359
4RESULTS	Exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of LVEF but not in patients with preserved LVEF .	360
1CONCLUSIONS	These results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction .	361
3OBJECTIVE	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 .	362
2METHODS	Thirty-seven AFH staff-caregivers and 47 residents with comorbid dementia and sleep disturbances .	363
2METHODS	SEP consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans .	364
2METHODS	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 .	365
2METHODS	Resident sleep was assessed by wrist actigraphy at baseline , 1-month posttreatment , and 6-month follow-up .	366
2METHODS	Caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected .	367
4RESULTS	Each key area of treatment fidelity ( SEP delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes .	368
4RESULTS	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 .	369
4RESULTS	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 .	370
1CONCLUSIONS	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 .	371
3OBJECTIVE	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 .	372
2METHODS	This was an open-label , randomized , parallel , three-arm multicenter trial in patients with type 2 diabetes starting insulin treatment .	373
2METHODS	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 .	374
2METHODS	Primary end point was the postprandial glucose excursion 2 h after breakfast at the end of study .	375
2METHODS	Secondary outcomes included HbA1c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction .	376
4RESULTS	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 .	377
4RESULTS	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 ) .	378
4RESULTS	Nevertheless , HbA1c decreased by 1.1 % ( lispro ) and 1.2 % ( MidMix ) , vs. 0.3 % with glargine .	379
4RESULTS	Hypoglycemic episodes were rare with 1-1 .5 self-reported episodes per 100 patient-days .	380
1CONCLUSIONS	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 .	381
1CONCLUSIONS	These results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving HbA1c targets .	382
0BACKGROUND	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 .	383
0BACKGROUND	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 .	384
2METHODS	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 .	385
2METHODS	Due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information .	386
2METHODS	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 .	387
2METHODS	Each condition was a single 60-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention .	388
2METHODS	Women underwent interviewer-administered surveys and testing for HIV , syphilis , gonorrhea , Chlamydia , and Trichomonas at baseline and quarterly for 12 months .	389
2METHODS	Combined HIV/STI incidence will be the primary outcome .	390
2METHODS	Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients .	391
1CONCLUSIONS	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 ) .	392
1CONCLUSIONS	All 584 participants completed the baseline interview , provided biological samples and were randomized to one of the four groups .	393
1CONCLUSIONS	During follow-up , 17 participants ( 2.9 % ) were lost to follow-up , of whom 10 ( 58.8 % ) had died , leaving 567 participants for analysis .	394
1CONCLUSIONS	This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs .	395
1CONCLUSIONS	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 .	396
0BACKGROUND	NCT00840658 .	397
3OBJECTIVE	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 .	398
2METHODS	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 .	399

4RESULTS

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 .

300

4RESULTS

There was no significant change in LDL subclass distribution .

301

1CONCLUSIONS

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 .

302

1CONCLUSIONS

Garlic may have a greater effect on LDL particle diameter in LDL pattern A compared with pattern B subjects .

303

1CONCLUSIONS

This difference was not reflected in other plasma lipid measurements .

304

0BACKGROUND

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 .

305

3OBJECTIVE

To assess the learning curve and skill-keeping line of ileoscopy .

306

2METHODS

Prospective randomized study .

307

2METHODS

Single GI endoscopy unit .

308

2METHODS

Adult outpatients referred for colonoscopy .

309

2METHODS

Patient randomization to ileocolonoscopy by trainees and seniors .

310

2METHODS

Ileoscopy skill was divided into the following : ileocecal valve ( ICV ) intubation ( success rate , time ) and ileal exploration ( length , time ) .

311

2METHODS

Consecutive blocks of 10 procedures were used to calculate the learning curve and the skill-keeping line .

312

2METHODS

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 .

313

4RESULTS

Learning curve showed that competency in ICV intubation ( 80 % success rate ) and ileal exploration ( 16 cm ) was achieved after 50 procedures .

314

4RESULTS

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 .

315

4RESULTS

Thin-lipped and volcanic ICV are the most difficult and easiest to intubate , respectively .

316

4RESULTS

Crohn 's disease and adenomas of the proximal edge of ICV were diagnosed in 2.2 % .

317

1CONCLUSIONS

Training in ileoscopy is recommended to achieve competency , and endoscopists should consider practicing ICV intubation to maintain and increase their skill .

318

1CONCLUSIONS

Ileoscopy can be difficult when the ICV is thin lipped or single bulged , and easy when it has a volcanic morphology .

319

3OBJECTIVE

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 ) .

320

2METHODS

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 .

321

2METHODS

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 .

322

2METHODS

Patients who were rated as slightly improved were defined as the minimally changed subgroup and compared with patients rated as moderately or markedly improved .

323

4RESULTS

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 ) .

324

4RESULTS

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 .

325

1CONCLUSIONS

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 .

326

3OBJECTIVE

Long-term pharmacological glucocorticoid ( GC ) therapy leads to skeletal muscle atrophy and weakness .

327

3OBJECTIVE

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 .

328

2METHODS

This was a prospective , open-label , randomised , crossover study .

329

2METHODS

Twelve men ( age 746 years ) on chronic GC treatment participated .

330

2METHODS

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 .

331

4RESULTS

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 .

332

4RESULTS

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 ) .

333

4RESULTS

The increase in ASMM was larger with combined treatment than either GH or testosterone alone ( P < 0.05 ) .

334

4RESULTS

ECW increased significantly after GH + testosterone by 1.52.6 l ( P = 0.038 ) but not after GH or testosterone alone .

335

4RESULTS

BCM increased slightly after single and combined treatments , but the changes were not significant .

336

4RESULTS

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 .

337

1CONCLUSIONS

GH and testosterone induce favourable and additive body compositional changes in men on chronic , low-dose GC treatment .

338

1CONCLUSIONS

In the doses used , combination therapy increases fasting and postprandial glucose concentration .

339

0BACKGROUND

Utilization rates ( URs ) for implantable cardioverter-defibrillators ( ICDs ) for primary prevention of sudden cardiac death ( PPSCD ) are lacking in the community .

340

3OBJECTIVE

The purpose of this study was to establish the ICD UR in central Indiana .

341

2METHODS

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 .

342

2METHODS

ICD eligibility and utilization were determined from chart review .

343

4RESULTS

We identified 1863 patients with at least 1 low EF study .

344

4RESULTS

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 .

345

4RESULTS

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 .

346

4RESULTS

Eight of 300 ( 2.7 % ) actually had ICD implantation for PPSCD .

347

4RESULTS

Review of all 191 patients in the ICD procedure code cohort identified 70 with ICD implantation for PPSCD .

348

4RESULTS

The ICD UR ( ratio between patients with ICD for PPSCD and all with indication ) was 38 % overall ( 95 % confidence interval [ CI ] 28 % -49 % ) .

349

4RESULTS

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 ) .

350

1CONCLUSIONS

ICD UR is 38 % among patients meeting class I indications , suggesting further opportunities for improving guideline compliance .

351

1CONCLUSIONS

This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review .

352

3OBJECTIVE

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 ) .

353

2METHODS

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 .

354

2METHODS

Left ventricular function , left ventricular dimensions , and exercise tolerance were assessed before and after each intervention .

355

4RESULTS

Exercise tolerance and LVEF increased with exercise training in all patient groups , whereas they remained unchanged after usual care alone .

356

4RESULTS

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 .

357

4RESULTS

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 .

358

4RESULTS

In the remaining patients ( DT > 160 ms ) , exercise training also improved mitral inflow patterns .

359

4RESULTS

Exercise training decreased left ventricular dimensions in patients with mild and moderate to severe reduction of LVEF but not in patients with preserved LVEF .

360

1CONCLUSIONS

These results indicate that exercise training can improve the course of heart failure independent of the degree of baseline left ventricular dysfunction .

361

3OBJECTIVE

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 .

362

2METHODS

Thirty-seven AFH staff-caregivers and 47 residents with comorbid dementia and sleep disturbances .

363

2METHODS

SEP consisted of four training sessions with staff-caregivers to develop and implement individualized resident behavioral sleep plans .

364

2METHODS

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 .

365

2METHODS

Resident sleep was assessed by wrist actigraphy at baseline , 1-month posttreatment , and 6-month follow-up .

366

2METHODS

Caregiver reports of resident daytime sleepiness , depression , and disruptive behaviors were also collected .

367

4RESULTS

Each key area of treatment fidelity ( SEP delivery , receipt , enactment ) was identified , measured , and yielded significant outcomes .

368

4RESULTS

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 .

369

4RESULTS

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 .

370

1CONCLUSIONS

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 .

371

3OBJECTIVE

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 .

372

2METHODS

This was an open-label , randomized , parallel , three-arm multicenter trial in patients with type 2 diabetes starting insulin treatment .

373

2METHODS

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 .

374

2METHODS

Primary end point was the postprandial glucose excursion 2 h after breakfast at the end of study .

375

2METHODS

Secondary outcomes included HbA1c , self-monitored blood glucose profiles , hypoglycemic episodes , body weight , and patient satisfaction .

376

4RESULTS

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 .

377

4RESULTS

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 ) .

378

4RESULTS

Nevertheless , HbA1c decreased by 1.1 % ( lispro ) and 1.2 % ( MidMix ) , vs. 0.3 % with glargine .

379

4RESULTS

Hypoglycemic episodes were rare with 1-1 .5 self-reported episodes per 100 patient-days .

380

1CONCLUSIONS

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 .

381

1CONCLUSIONS

These results support studies suggesting that control of postprandial hyperglycemia plays a key role in achieving HbA1c targets .

382

0BACKGROUND

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 .

383

0BACKGROUND

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 .

384

2METHODS

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 .

385

2METHODS

Due to the extreme vulnerability of this population , we did not include a control group that would deny some women access to preventive information .

386

2METHODS

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 .

387

2METHODS

Each condition was a single 60-minute session , including either an interactive or didactic version of an injection risk intervention and sexual risk intervention .

388

2METHODS

Women underwent interviewer-administered surveys and testing for HIV , syphilis , gonorrhea , Chlamydia , and Trichomonas at baseline and quarterly for 12 months .

389

2METHODS

Combined HIV/STI incidence will be the primary outcome .

390

2METHODS

Secondary outcomes are proportionate reductions in sharing of injection equipment and unprotected sex with clients .

391

1CONCLUSIONS

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 ) .

392

1CONCLUSIONS

All 584 participants completed the baseline interview , provided biological samples and were randomized to one of the four groups .

393

1CONCLUSIONS

During follow-up , 17 participants ( 2.9 % ) were lost to follow-up , of whom 10 ( 58.8 % ) had died , leaving 567 participants for analysis .

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1CONCLUSIONS

This study appears to be the first intervention to attempt to simultaneously reduce injection and sexual risk behaviors among FSW-IDUs .

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1CONCLUSIONS

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 .

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0BACKGROUND

NCT00840658 .

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3OBJECTIVE

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 .

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2METHODS

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 .

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