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RESULTS 189 patients were screened and 130 randomly assigned to placebo ( 66 patients ) or dalcetrapib ( 64 patients ) . |
RESULTS 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 . |
RESULTS 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 ) . |
RESULTS 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 ) . |
RESULTS Dalcetrapib did not increase office blood pressure and the frequency of adverse events was similar between groups . |
CONCLUSIONS Dalcetrapib showed no evidence of a pathological effect related to the arterial wall over 24 months . |
CONCLUSIONS 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 . |
BACKGROUND F Hoffmann-La Roche Ltd. . |
###24629703 |
BACKGROUND 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 . |
OBJECTIVE 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 . |
METHODS In four Dutch hospitals , children aged 16 years with a both-bone forearm fracture were prospectively followed up consecutive children for 6-9 months . |
METHODS At the final follow-up , pronation/supination and angular malunion on radiographs were determined . |
RESULTS 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 . |
RESULTS The mean age of the children was 8.0 ( 3.5 ) years , of which 63 % were male and 40 % fractured their dominant arm . |
RESULTS The mean time to final examination was 219 ( 51 ) days . |
RESULTS 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 . |
RESULTS 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 . |
CONCLUSIONS 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 . |
###19960205 |
BACKGROUND 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 ) . |
BACKGROUND Postoperative paraesophageal herniation has an incidence range up to 7 % in the immediate postoperative period . |
OBJECTIVE 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 . |
METHODS Eighty-two patients with GERD were randomized to LNF combined with ( group A , n = 40 ) or without ( group B , n = 42 ) posterior gastropexy . |
METHODS 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 . |
METHODS 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 . |
METHODS Posterior gastropexy ( group A ) was performed with one stitch between the posterior wall of the wrap and the crura near the arcuate ligament . |
RESULTS 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 ] . |
RESULTS 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 . |
RESULTS 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 . |
RESULTS 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 ) . |
CONCLUSIONS 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 . |
CONCLUSIONS ( Registered Clinical Trial number : NCT00872755 . |
CONCLUSIONS www.clinicaltrials.gov . ) |
###23410885 |
BACKGROUND Vitamin D deficiency is common in the general public and athletic populations and may impair skeletal muscle function . |
BACKGROUND We therefore assessed the effects of vitamin D3 supplementation on serum 25 [ OH ] D concentrations and physical performance . |
METHODS 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 . |
METHODS 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 . |
METHODS Vitamin D deficiency was defined in accordance with the US Institute of Medicine guideline ( < 50 nmol/l ) . |
RESULTS 57 % of the subject population were vitamin D deficient at baseline ( meanSD value 5124 nmol/l ) . |
RESULTS 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 . |
RESULTS In contrast , vitamin D concentration in the PLB group decreased at 6 and 12 weeks ( 3718 and 4122 nmol/l , respectively ) . |
RESULTS Increasing serum 25 [ OH ] D had no significant effect on any physical performance parameter ( p > 0.05 ) . |
CONCLUSIONS 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 . |
###18822974 |
OBJECTIVE To probe into the clinical therapeutic effect of acupuncture on coronary heart disease complicated by type 2 diabetes mellitus ( CDM ) and the mechanism . |
METHODS 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 . |
METHODS 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 ) . |
METHODS 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. . |
METHODS The treatment was given twice a day in the two groups . |
METHODS 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. . |
RESULTS 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 ) . |
RESULTS The markedly effective rate for improvement of ECG was 50.00 % in the observation group and 13.79 % in the control group . |
CONCLUSIONS 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 . |
###16308853 |
BACKGROUND 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 . |
BACKGROUND Use of the isotope adds extra cost and there are potential radiation hazards . |
BACKGROUND The two techniques were compared in a randomized trial . |
METHODS Women with early breast cancer ( less than 3 cm ) and no palpable axillary nodes were recruited . |
METHODS Women older than 70 years with multicentric cancers or previous surgery to the breast or axilla were excluded . |
METHODS Patients were randomized to either blue dye alone or combined mapping for SLN biopsy . |
METHODS All women had a level I and II axillary dissection after the SLN biopsy . |
RESULTS A total of 123 patients were recruited , of whom five were excluded from analysis . |
RESULTS Blue dye alone was used in 57 women and 61 had combined mapping . |
RESULTS Baseline demographic data were similar in the two cohorts . |
RESULTS The success rate of SLN biopsy was higher with combined mapping than with blue dye alone ( 100 versus 86 per cent ; P = 0.002 ) . |
RESULTS 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 ) . |
CONCLUSIONS Combined mapping was superior to blue dye alone in identification of the SLN , but accuracy and false-negative rates were similar . |
###22624776 |
BACKGROUND Knowledge translation ( KT ) research in long-term care ( LTC ) is still in its early stages . |
BACKGROUND 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 . |
METHODS The Vitamin D and Osteoporosis Study ( ViDOS ) is underway in 40 LTC homes ( n = 19 intervention , n = 21 control ) across Ontario , Canada . |
METHODS 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 . |
METHODS Eligibility criteria are LTC homes that are serviced by our partner pharmacy provider and have more than one prescribing physician . |
METHODS The target audience within each LTC home is the Professional Advisory Committee ( PAC ) , an interdisciplinary team who meets quarterly . |
METHODS 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 . |
METHODS Control homes do not receive any intervention , however both intervention and control homes received educational materials as part of the Ontario Osteoporosis Strategy . |
METHODS 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 . |
METHODS Secondary outcomes include the proportion of residents prescribed calcium supplements and osteoporosis medications , and falls and fractures . |
METHODS Qualitative methods will examine the experience of the LTC team with the KT intervention . |
METHODS Homes are centrally randomized to intervention and control groups in blocks of variable size using a computer generated allocation sequence . |
METHODS Randomization is stratified by home size and profit/nonprofit status . |
METHODS Prescribing data retrieval and analysis are performed by blinded personnel . |
CONCLUSIONS Our study will contribute to an improved understanding of the feasibility and acceptability of a multifaceted intervention aimed at translating knowledge to LTC practitioners . |
CONCLUSIONS Lessons learned from this study will be valuable in guiding future research and understanding the complexities of translating knowledge in LTC . |
###24036634 |
OBJECTIVE To describe the psychometric properties and identify the minimally important difference ( MID ) of the hepatitis C virus patient-reported outcomes ( HCV-PRO ) instrument . |
OBJECTIVE Chronic HCV infection and associated treatments negatively affect PROs of function and well-being . |
METHODS In a phase 2 trial , HCV-infected patients received direct-acting antivirals ( DAAs ) for 12weeks with peg-interferon/ribavirin ( peg-IFN/RBV ) for 48weeks , or placebo plus peg-IFN/RBV . |
METHODS The HCV-PRO total score , SF-36 PCS and MCS scores , EQ-5D-3L , and EQ VAS were measured at baseline , week 8 , end of DAA treatment ( EODT ) , end of peg-IFN/RBV treatment ( EOT ) , and posttreatment week 24 ( SVR24 ) . |
METHODS Convergent validity of the HCV-PRO was assessed by Pearson 's correlation coefficients . |
METHODS Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores ( none vs. some ) and presence/absence of depression or fatigue adverse events . |