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2METHODS
Each treatment group received both an injection and a tablet to reduce treatment group variability .
400
2METHODS
Patients were evaluated using the Brief Psychiatric Rating Scale ( BPRS ) and the Positive and Negative Syndrome Scale ( PANSS ) before receiving medication and at 30 and 90 minutes after medication was administered .
401
2METHODS
The intergroup mean percent reductions in rating scale scores were compared using ANOVA , chi-square , and Kruskal-Wallis tests .
402
4RESULTS
There were no statistically significant differences among the groups at any point .
403
4RESULTS
The two groups receiving an antipsychotic plus lorazepam showed a trend towards increased symptom reduction compared with the group receiving lorazepam alone , although this trend was not statistically significant .
404
1CONCLUSIONS
Lorazepam alone was as effective as lorazepam plus haloperidol or lorazepam plus risperidone in this small trial .
405
1CONCLUSIONS
While not statistically significant , a trend toward better outcomes with combined treatment warrants further study .
406
3OBJECTIVE
To prospectively evaluate the efficacy of routine ultrasound-guided fine-needle aspiration cytology ( FNAC ) of thyroid nodules in an endemic area and to analyze the factors influencing it .
407
2METHODS
Patients with thyroid nodules were randomly subjected to either conventional palpation-guided fine-needle aspiration cytology ( PFNAC ) or ultrasound-guided fine-needle aspiration cytology ( USFNAC ) .
408
2METHODS
The results of cytology were compared with the final histopathologic diagnosis in 112 patients who had undergone surgery .
409
2METHODS
The performance of both methods was individually analyzed in solid nodules , cystic nodules , and solitary and multinodular goitres .
410
4RESULTS
Overall , USFNAC showed a significantly higher sensitivity ( 83.3 % vs 54.6 % , p < .001 ) , positive predictive value ( 100 % vs 85.7 % , p < .001 ) , and greater diagnostic accuracy ( 96.5 % vs 89.1 % , p = .052 ) compared with PFNAC .
411
4RESULTS
The sensitivity of USFNAC was significantly higher compared with that of PFNAC in cystic and complex nodules ( 75 % vs 50 % , p < .001 ) but not in solid nodules ( 77.8 % vs 75 % , p > .05 ) .
412
4RESULTS
USFNAC was more sensitive and more accurate than PFNAC for detection of malignancy in multinodular goitres ( 66.7 % vs 50 % , p < .05 ; 95.6 % vs 86.2 % , p < .05 , respectively ) .
413
1CONCLUSIONS
The superiority of `` routine '' USFNAC over PFNAC is mainly due to its better performance in cystic nodules and multinodular goitres .
414
1CONCLUSIONS
Hence , routine USFNAC can be recommended in areas where such lesions constitute the majority of thyroid nodules .
415
0BACKGROUND
Dalcetrapib modulates cholesteryl ester transfer protein ( CETP ) activity to raise high-density lipoprotein cholesterol ( HDL-C ) .
416
0BACKGROUND
After the failure of torcetrapib it was unknown if HDL produced by interaction with CETP had pro-atherogenic or pro-inflammatory properties .
417
0BACKGROUND
dal-PLAQUE is the first multicentre study using novel non-invasive multimodality imaging to assess structural and inflammatory indices of atherosclerosis as primary endpoints .
418
2METHODS
In this phase 2b , double-blind , multicentre trial , patients ( aged 18-75 years ) with , or with high risk of , coronary heart disease were randomly assigned ( 1:1 ) to dalcetrapib 600 mg/day or placebo for 24 months .
419
2METHODS
Randomisation was done with a computer-generated randomisation code and was stratified by centre .
420
2METHODS
Patients and investigators were masked to treatment .
421
2METHODS
Coprimary endpoints were MRI-assessed indices ( total vessel area , wall area , wall thickness , and normalised wall index [ average carotid ] ) after 24 months and ( 18 ) F-fluorodeoxyglucose ( ( 18 ) F-FDG ) PET/CT assessment of arterial inflammation within an index vessel ( right carotid , left carotid , or ascending thoracic aorta ) after 6 months , with no-harm boundaries established before unblinding of the trial .
422
2METHODS
Analysis was by intention to treat .
423
2METHODS
This trial is registered at ClinicalTrials.gov , NCT00655473 .
424
4RESULTS
189 patients were screened and 130 randomly assigned to placebo ( 66 patients ) or dalcetrapib ( 64 patients ) .
425
4RESULTS
For the coprimary MRI and PET/CT endpoints , CIs were below the no-harm boundary or the adverse change was numerically lower in the dalcetrapib group than in the placebo group .
426
4RESULTS
MRI-derived change in total vessel area was reduced in patients given dalcetrapib compared with those given placebo after 24 months ; absolute change from baseline relative to placebo was -401 mm ( 2 ) ( 90 % CI -723 to -080 ; nominal p = 004 ) .
427
4RESULTS
The PET/CT measure of index vessel most-diseased-segment target-to-background ratio ( TBR ) was not different between groups , but carotid artery analysis showed a 7 % reduction in most-diseased-segment TBR in the dalcetrapib group compared with the placebo group ( -73 [ 90 % CI -135 to -08 ] ; nominal p = 007 ) .
428
4RESULTS
Dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups .
429
1CONCLUSIONS
Dalcetrapib showed no evidence of a pathological effect related to the arterial wall over 24 months .
430
1CONCLUSIONS
Moreover , this trial suggests possible beneficial vascular effects of dalcetrapib , including the reduction in total vessel enlargement over 24 months , but long-term safety and clinical outcomes efficacy of dalcetrapib need to be analysed .
431
0BACKGROUND
F Hoffmann-La Roche Ltd. .
432
0BACKGROUND
Although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data .
433
3OBJECTIVE
The purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture .
434
2METHODS
In four Dutch hospitals , children aged 16 years with a both-bone forearm fracture were prospectively followed up consecutive children for 6-9 months .
435
2METHODS
At the final follow-up , pronation/supination and angular malunion on radiographs were determined .
436
4RESULTS
Between January 2006 and August 2010 , a total of 410 children were prospectively followed up , of which 393 children were included for analysis in this study .
437
4RESULTS
The mean age of the children was 8.0 ( 3.5 ) years , of which 63 % were male and 40 % fractured their dominant arm .
438
4RESULTS
The mean time to final examination was 219 ( 51 ) days .
439
4RESULTS
Children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of 15 had a 9-13 % chance of developing a clinically relevant limitation ( i.e. , < 50 of pronation and/or supination ) , while children with an angular malalignment of 16 had a 60 % chance .
440
4RESULTS
Children with diaphyseal both-bone forearm fractures with 5 of angular malalignment had a 13 % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment .
441
1CONCLUSIONS
Children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment .
442
0BACKGROUND
Laparoscopic Nissen fundoplication ( LNF ) has become established as the procedure of choice in the surgical management of the majority of patients suffering from gastroesophageal reflux disease ( GERD ) .
443
0BACKGROUND
Postoperative paraesophageal herniation has an incidence range up to 7 % in the immediate postoperative period .
444
3OBJECTIVE
A prospective randomized trial was scheduled to study the role of posterior gastropexy , in combination with LNF , in prevention of paraesophageal herniation and improvement of postoperative results in surgical treatment of GERD .
445
2METHODS
Eighty-two patients with GERD were randomized to LNF combined with ( group A , n = 40 ) or without ( group B , n = 42 ) posterior gastropexy .
446
2METHODS
Subjective evaluation using disease-specific and generic questionnaires and structured interviews , and objective evaluation by endoscopy , esophageal manometry , and 24-h pH monitoring , were performed before operation , at 2 and 12 months after surgery , and then every year .
447
2METHODS
Crura approximation was performed by stitches if the diameter was less than 6 cm , or with a patch to reinforce the conventional crural closure or by tension-free technique to close the hiatus .
448
2METHODS
Posterior gastropexy ( group A ) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament .
449
4RESULTS
Sixteen patients of group A and 15 patients of group B with concomitant abdominal diseases had simultaneous procedures [ cholecystectomy 25 , vagotomy 2 , ventral hernia repair 1 , gastric polypectomy 1 , gastric fundus diverticulectomy 1 , gastrointestinal stromal tumor ( GIST ) wedge resection 1 ] .
450
4RESULTS
In mean follow-up of 48 + / - 26 months ( range 7-94 months ) , one patient of group B presented with paraesophageal herniation in the first postoperative month ( reoperation ) , while recurrent gastroesophageal reflux ( Visick III or IV ) , successfully treated by medication , was noted in three patients of group B and in one patient of group A. Only mild dysphagia , during the first two postoperative months , was noted in nine patients of group A and eight patients of group B. Six patients of each group with Barrett 's esophagus had endoscopic improvement after the second postoperative month .
451
4RESULTS
Visick score in groups A/B was I in 26/11 ( P < 0.0001 ) , II in 13/27 ( P = 0.037 ) , III in 1/2 ( not significant , NS ) , and IV in 0/2 .
452
4RESULTS
Generally , Visick score was I or II in 39/38 in groups A/B ( 97.5 % / 90.5 % , NS ) and III or IV in 1/4 ( 2.5 % / 9.5 % , P < 0.0001 ) .
453
1CONCLUSIONS
LNF combined with posterior gastropexy may prevent postoperative paraesophageal or sliding herniation in surgical treatment of GERD , providing better early and long-term postoperative results .
454
1CONCLUSIONS
( Registered Clinical Trial number : NCT00872755 .
455
1CONCLUSIONS
www.clinicaltrials.gov . )
456
0BACKGROUND
Vitamin D deficiency is common in the general public and athletic populations and may impair skeletal muscle function .
457
0BACKGROUND
We therefore assessed the effects of vitamin D3 supplementation on serum 25 [ OH ] D concentrations and physical performance .
458
2METHODS
30 club-level athletes were block randomised ( using baseline 25 [ OH ] D concentrations ) into one of three groups receiving either a placebo ( PLB ) , 20 000 or 40 000 IU/week oral vitamin D3 for 12 weeks .
459
2METHODS
Serum 25 [ OH ] D and muscle function ( 1-RM bench press and leg press and vertical jump height ) were measured presupplementation , 6 and 12 weeks postsupplementation .
460
2METHODS
Vitamin D deficiency was defined in accordance with the US Institute of Medicine guideline ( < 50 nmol/l ) .
461
4RESULTS
57 % of the subject population were vitamin D deficient at baseline ( meanSD value 5124 nmol/l ) .
462
4RESULTS
Following 6 and 12 weeks supplementation with 20 000 IU ( 7914 and 8510 nmol/l , respectively ) or 40 000 IU vitamin D3 ( 9814 and 9124 nmol/l , respectively ) , serum vitamin D concentrations increased in all participants , with every individual achieving concentrations greater than 50 nmol/l .
463
4RESULTS
In contrast , vitamin D concentration in the PLB group decreased at 6 and 12 weeks ( 3718 and 4122 nmol/l , respectively ) .
464
4RESULTS
Increasing serum 25 [ OH ] D had no significant effect on any physical performance parameter ( p > 0.05 ) .
465
1CONCLUSIONS
Both 20 000 and 40 000 IU vitamin D3 supplementation over a 6-week period elevates serum 25 [ OH ] D concentrations above 50 nmol/l , but neither dose given for 12 weeks improved our chosen measures of physical performance .
466
3OBJECTIVE
To probe into the clinical therapeutic effect of acupuncture on coronary heart disease complicated by type 2 diabetes mellitus ( CDM ) and the mechanism .
467
2METHODS
Using multi-central , randomized , controlled and blind methods , 120 cases of CDM were divided into an observation group and a control group , 60 cases in each group .
468
2METHODS
They were treated by routine therapy for diabetes mellitus , and in the observation group , acupuncture at Quchi ( LI 11 ) , Hegu ( LI 4 ) , Xuehai ( SP 10 ) , Zusanli ( ST 36 ) , Yinlingquan ( SP 9 ) , Fenglong ( ST 40 ) .
469
2METHODS
Diji ( SP 8 ) , Sanyinjiao ( SP 6 ) , etc. were added with the needling method for regulating spleen-stomach ; while in the control group , acupuncture was given at Weiwanxiashu ( EX-B 3 ) , Feishu ( BL 13 ) , Pishu ( BL 20 ) , Shenshu ( BL 23 ) , Yanglingquan ( GB 34 ) , etc. .
470
2METHODS
The treatment was given twice a day in the two groups .
471
2METHODS
Clinical therapeutic effects were assessed according to clinical symptoms and signs , frequency and lasting time of angina pectoris , quantity of taking Glycerol Trinitrate , blood sugar , blood lipids , urinary albumin excretion rate , urinary beta2-microglobulin , urinary monocyte chemotactic protein-1 ( MCP-1 ) , ECG , heart color Doppler , etc. .
472
4RESULTS
The needling method for regulating spleen-stomach not only could improve the symptoms and signs of the patient , but also could improve the degree of ST segment moving down and the function of left artrium relaxation , and had benign regulative effect on glycometabolism , lipids metabolism and urinary albumin level , with significant differences as compared with the control group ( P < 0.05 or P < 0.01 ) .
473
4RESULTS
The markedly effective rate for improvement of ECG was 50.00 % in the observation group and 13.79 % in the control group .
474
1CONCLUSIONS
The needling method for regulating spleen-stomach can improve the damage of heart and blood vessels induced by abnormal sugar and lipids , decrease the level of urinary protein , inhibit MCP-1 excessive expression , relieve myocardial load and raise cardiac output in the patient of coronary heart disease complicated by type 2 diabetes mellitus .
475
0BACKGROUND
Use of blue dye alone as a marker for sentinel lymph node ( SLN ) biopsy is effective , but combining it with isotope marking can improve the success rate .
476
0BACKGROUND
Use of the isotope adds extra cost and there are potential radiation hazards .
477
0BACKGROUND
The two techniques were compared in a randomized trial .
478
2METHODS
Women with early breast cancer ( less than 3 cm ) and no palpable axillary nodes were recruited .
479
2METHODS
Women older than 70 years with multicentric cancers or previous surgery to the breast or axilla were excluded .
480
2METHODS
Patients were randomized to either blue dye alone or combined mapping for SLN biopsy .
481
2METHODS
All women had a level I and II axillary dissection after the SLN biopsy .
482
4RESULTS
A total of 123 patients were recruited , of whom five were excluded from analysis .
483
4RESULTS
Blue dye alone was used in 57 women and 61 had combined mapping .
484
4RESULTS
Baseline demographic data were similar in the two cohorts .
485
4RESULTS
The success rate of SLN biopsy was higher with combined mapping than with blue dye alone ( 100 versus 86 per cent ; P = 0.002 ) .
486
4RESULTS
The accuracy and false-negative rate were similar ( accuracy 100 per cent for combined mapping versus 98 per cent for blue dye ; false-negative rate 0 versus 5 per cent ) .
487
1CONCLUSIONS
Combined mapping was superior to blue dye alone in identification of the SLN , but accuracy and false-negative rates were similar .
488
0BACKGROUND
Knowledge translation ( KT ) research in long-term care ( LTC ) is still in its early stages .
489
0BACKGROUND
This protocol describes the evaluation of a multifaceted , interdisciplinary KT intervention aimed at integrating evidence-based osteoporosis and fracture prevention strategies into LTC care processes .
490
2METHODS
The Vitamin D and Osteoporosis Study ( ViDOS ) is underway in 40 LTC homes ( n = 19 intervention , n = 21 control ) across Ontario , Canada .
491
2METHODS
The primary objectives of this study are to assess the feasibility of delivering the KT intervention , and clinically , to increase the percent of LTC residents prescribed 800 IU of vitamin D daily .
492
2METHODS
Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician .
493
2METHODS
The target audience within each LTC home is the Professional Advisory Committee ( PAC ) , an interdisciplinary team who meets quarterly .
494
2METHODS
The key elements of the intervention are three interactive educational sessions led by an expert opinion leader , action planning using a quality improvement cycle , audit and feedback reports , nominated internal champions , and reminders/point-of-care tools .
495
2METHODS
Control homes do not receive any intervention , however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy .
496
2METHODS
Primary outcomes are feasibility measures ( recruitment , retention , attendance at educational sessions , action plan items identified and initiated , internal champions identified , performance reports provided and reviewed ) , and vitamin D ( 800 IU/daily ) prescribing at 6 and 12 months .
497
2METHODS
Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications , and falls and fractures .
498
2METHODS
Qualitative methods will examine the experience of the LTC team with the KT intervention .
499