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3,829,814 | 24,260,122 |
OBJECTIVE
To determine effects of probiotic consumption on clinical and immunological parameters of seasonal allergic rhinitis (SAR) in an out-of-season single nasal allergen challenge.
METHODS
In a study registered at ClinicalTrials.Gov (NCT01123252), a 16-week dietary intervention was undertaken in 60 patients with allergic rhinitis (>16 years old). Using a double-blinded, placebo-controlled anonymised design, the patients were divided equally into two groups. One group was given a dairy drink containing Lactobacillus casei Shirota to ingest daily while the other consumed a similar drink without bacteria. Participants attended the clinic on two consecutive days before the intervention and then again at the end of the study period. On the first day of each 2-day visit, following clinical examination, assessments were made of total nasal symptoms scores and peak nasal inspiratory flow. Nasal scrapings, nasal lavage and blood were collected for laboratory analyses of cellular phenotypes, soluble mediator release and in vitro responses to pollen allergen. These procedures were repeated 24 hours following nasal allergen challenge.
RESULTS
Prior to and following intervention there were no detectable differences between study groups in measured clinical outcome. After intervention, there were differences between groups in their percentages of CD86+ epithelial cells (p = 0.0148), CD86+CD252+ non-epithelial cells (p = 0.0347), sIL-1RII release (p = 0.0289) and IL-1β (p = 0.0224) levels at the nasal mucosa. Delivery of probiotic also suppressed production of sCD23 (p = 0.0081), TGF-β (p = 0.0283) and induced increased production of IFN-γ (p = 0.0351) in supernatants of cultured peripheral blood.
CONCLUSIONS & CLINICAL RELEVANCE
This study did not show significant probiotic-associated changes with respect to the primary clinical endpoint. An absence of overt clinical benefit may be due to an inability of single nasal challenges to accurately represent natural allergen exposure. Nevertheless, oral delivery of probiotics produced changes of the immunological microenvironment at the nasal mucosa in individuals affected by SAR.
TRIAL REGISTRATION
ClinicalTrials.Gov NCT01123252.
| 1significant effect
|
4,128,609 | 25,114,789 |
OBJECTIVE
To evaluate the non-inferiority of pramipexole extended-release (ER) versus immediate-release (IR) in Chinese patients with Parkinson's disease (PD) in a double-blind, randomized, parallel-group study.
METHODS
Subjects were Chinese patients with idiopathic PD with diagnosis ≥ 2 years prior to trial, age ≥ 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during 'on'-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). Non-inferiority was based on the primary endpoint, the change from baseline to end of maintenance (week 18) in the UPDRS (Parts II + III) total score.
RESULTS
For the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate). The adjusted mean between group difference was 0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 95% CI (-1.047) for treatment difference was higher than the non-inferiority margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm with few severe AEs (ER: 2.1%; IR: 3.8%).
CONCLUSION
Based on the UPDRS II + III score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of pramipexole ER and IR were similar. These results were based on comparable mean daily doses and durations of treatment for both formulations.
| 0no significant effect
|
2,686,715 | 19,439,096 |
BACKGROUND
A previous study showed that a high percentage of children diagnosed with Hyperkinetic Disorder (HKD) displayed a consistent pattern of motor function problems. The purpose of this study was to investigate the effect of methylphenidate (MPH) on such motor performance in children with HKD METHODS: 25 drug-naïve boys, aged 8-12 yr with a HKD-F90.0 diagnosis, were randomly assigned into two groups within a double blind cross-over design, and tested with a motor assessment instrument, during MPH and placebo conditions.
RESULTS
The percentage of MFNU scores in the sample indicating 'severe motor problems' ranged from 44-84%, typically over 60%. Highly significant improvements in motor performance were observed with MPH compared to baseline ratings on all the 17 subtests of the MFNU 1-2 hr after administration of MPH. There were no significant placebo effects. The motor improvement was consistent with improvement of clinical symptoms.
CONCLUSION
The study confirmed our prior clinical observations showing that children with ADHD typically demonstrate marked improvements of motor functions after a single dose of 10 mg MPH. The most pronounced positive MPH response was seen in subtests measuring either neuromotor inhibition, or heightened muscular tone in the gross movement muscles involved in maintaining the alignment and balance of the body. Introduction of MPH generally led to improved balance and a generally more coordinated and controlled body movement.
| 1significant effect
|
3,961,596 | 24,535,625 |
INTRODUCTION
Luseogliflozin, a sodium glucose cotransporter 2 inhibitor, inhibits reabsorption of glucose in the proximal renal tubule. It was developed for the treatment of type 2 diabetes mellitus.
METHODS
For this first human study of luseogliflozin, randomized, single-blind, placebo-controlled, single ascending dose (1-25 mg) and multiple ascending dose (5 or 10 mg/day, 7 days) trials were conducted in healthy male Japanese subjects to investigate safety, pharmacokinetics, and pharmacodynamics.
RESULTS
There were no serious adverse events, adverse events leading to discontinuation, or episodes of hypoglycemia. After administration of a single oral dose of luseogliflozin, its maximum plasma level (C max) and area under the concentration-time curve increased in a dose-dependent manner, and no food effects were observed on pharmacokinetics. The mean time taken to reach C max (T max) ranged from 0.667 to 2.25 h. The mean plasma half-life of luseogliflozin (T 1/2) after multiple dosing for 7 days ranged from 9.14 to 10.7 h, and no detectable accumulation of luseogliflozin was observed. Urinary glucose excretion increased in a dose-dependent manner, ranging from 18.9 to 70.9 g (single-dose study).
CONCLUSION
Luseogliflozin was well tolerated and showed favorable pharmacokinetic and pharmacodynamic profiles in healthy male Japanese subjects.
| 0no significant effect
|
5,697,645 | 28,448,688 |
AIMS
To evaluate the efficacy and safety of evogliptin, a newly developed dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes (T2D) inadequately controlled by diet and exercise.
MATERIALS AND METHODS
In this randomized, double-blind, placebo-controlled, parallel-group, multicentre, phase III study, 160 patients with T2D were assigned to either evogliptin 5 mg or placebo for 24 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to week 24.
RESULTS
The mean baseline HbA1c levels were similar in the evogliptin and the placebo groups (7.20% ± 0.56% vs 7.20% ± 0.63%, respectively). At week 24, evogliptin significantly reduced HbA1c levels from baseline compared with placebo (-0.23% vs 0.05%, respectively, P < .0001). Additionally, the proportion of patients achieving HbA1c <6.5% was significantly higher in the evogliptin group than in the placebo group (33.3% vs 15.2%; P = .008). The overall incidence of adverse events, including hypoglycaemia, was similar in the 2 groups.
CONCLUSIONS
In this 24-week study, once-daily evogliptin monotherapy significantly improved glycaemic control and was well tolerated in patients with T2D.
| 1significant effect
|
3,612,585 | 23,354,552 |
BACKGROUND
Palonosetron (Aloxi(®), Onicit(®)) is a pharmacologically unique 5-HT3 receptor antagonist (RA) approved as a single IV injection for the prevention of nausea and vomiting induced by chemotherapy (CINV) of either moderate or highly emetogenic potential (MEC and HEC, respectively). An oral palonosetron formulation has been developed and compared to the IV formulation.
METHODS
In this multinational, multicenter, double-blind, double-dummy, dose-ranging trial, 651 patients were randomly assigned to receive one of the following as a single dose prior to moderately emetogenic chemotherapy: oral palonosetron 0.25, 0.50, and 0.75 mg or IV palonosetron 0.25 mg. Patients were also randomized (1:1) to receive dexamethasone 8 mg IV or matched placebo on day 1. The primary endpoint was complete response (CR; no emesis, no rescue therapy) during the acute phase (0-24 h).
RESULTS
Acute CR rates were 73.5, 76.3, 74.1, and 70.4 % for all patients receiving the palonosetron 0.25, 0.50, and 0.75 mg oral doses, and for IV palonosetron 0.25 mg, respectively; delayed CR (24-120 h) rates were 59.4, 62.5, 60.1, and 65.4 %, and overall CR (0-120 h) rates were 53.5, 58.8, 53.2, and 59.3 %, respectively. The addition of dexamethasone improved emetic control (acute CR rate) by at least 15 % for all groups except oral palonosetron 0.25 mg, where the acute CR improvement was approximately 7 %. Adverse events were similar in nature, incidence, and intensity for all oral and IV palonosetron groups, and were the expected adverse events for 5-HT3 RAs (primarily headache and constipation).
CONCLUSION
Oral palonosetron has a similar efficacy and safety profile as IV palonosetron 0.25 mg and may be the preferred formulation in certain clinical situations. Among the tested oral treatments, a palonosetron 0.50-mg oral dose has been favored for the prevention of CINV in patients receiving moderately emetogenic chemotherapy due to a numerical gain in efficacy without a side effect disadvantage.
| 0no significant effect
|
3,289,190 | 22,375,213 |
PURPOSE
This study was performed to assess and compare the effects of Pilates exercise on flexibility and lumbo-pelvic movement control between the Pilates training and control groups.
METHODS
A randomized single-blinded controlled design was utilized in the study. Forty healthy male and female volunteers (mean age 31.65±6.21 years) were randomly divided into Pilates-based training (20 subjects) and the control groups (20 subjects). The Pilates group attended 45-minute training sessions, 2 times per week, for a period of 8 weeks. Flexibility and lumbo-pelvic stability tests were determined as outcome measures using a standard "sit and reach test" and "pressure biofeedback" respectively at 0, 4 and 8 weeks of the study.
RESULTS
The results showed that the Pilates training group improved flexibility significantly (P<0.001) during time intervals. This effect was also significantly greater than the control group for both 4 weeks and 8 weeks of the training period (P<0.001). There were 65% and 85% of the subjects from Pilates group passing the lumbo-pelvic stability test at 4 and 8 weeks of training periods respectively. No subjects from the control group passed the test at any stages.
CONCLUSIONS
Pilates can be used as an adjunctive exercise program to improve flexibility, enhance control-mobility of trunk and pelvic segments. It may also prevent and attenuate the predisposition to axial musculoskeletal injury.
| 1significant effect
|
4,450,858 | 26,018,581 |
BACKGROUND
One in four Australian births are induced. If cervical ripening using a prostaglandin is required, a pre-labour overnight hospitalisation and separation from family and support companions is necessary. Recent evidence shows that balloon catheter cervical ripening is just as effective as prostaglandins, but does not cause uterine stimulation. For women with low risk pregnancies, this offers the possibility of undergoing the overnight ripening process in their own home. We conducted a pilot randomised trial to assess the outcomes, clinical pathways and acceptability to both women and clinicians of outpatient balloon catheter ripening compared with usual inpatient care.
METHODS
Forty-eight women with low risk term pregnancies were randomised (2:1) to either outpatient (n = 33) or inpatient double-balloon catheter (n = 15) cervical ripening. Although not powered for statistically significant differences, the study explored potential direction of effect for key clinical outcomes such as oxytocin use, caesarean section and morbidities. Feedback on acceptability was sought from women at catheter insertion and 4 weeks after the birth, and from midwives and doctors, at the end of the study.
RESULTS
Clinical and perinatal outcomes were similar. Most women required oxytocin (77 %). The outpatient group were 24 % less likely to require oxytocin (risk difference -23.6 %, 95 % CI -43.8 to -3.5). There were no failed inductions, infections or uterine hyperstimulation attributable to the catheter in either group. Most women in both groups reported discomfort with insertion and wearing the catheter, but were equally satisfied with their care and felt the baby was safe (91 % both groups). Outpatient women reported feeling less isolated or emotionally alone. Most midwives and doctors (n = 90) agreed that they are more comfortable in sending home a woman with a catheter than prostaglandins and 90 % supported offering outpatient ripening to eligible women.
CONCLUSIONS
Outpatient balloon catheter ripening should be further investigated as an option for women in an adequately powered randomised trial.
TRIAL REGISTRATION
Prospectively registered, Australian New Zealand Clinical Trials Registry ACTRN12612001184864 .
| 1significant effect
|
4,030,092 | 24,595,629 |
OBJECTIVE
To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial.
RESEARCH DESIGN AND METHODS
ACCORD enrolled 10,251 type 2 diabetes patients aged 40-79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of <6.0% (<42 mmol/mol; intensive glycemia) or 7.0-7.9% (53-63 mmol/mol; standard glycemia) and then randomized a second time to either 1) systolic BP goals of <120 mmHg (intensive BP) or <140 mmHg (standard BP) or 2) simvastatin plus fenofibrate (intensive lipid) or simvastatin plus placebo (standard lipid). Proportional hazards models were used to assess combinations of treatment assignments on the composite primary (deaths due to CVD, nonfatal myocardial infarction [MI], and nonfatal stroke) and secondary outcomes.
RESULTS
In the BP trial, risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50-0.91), BP (HR 0.74; 95% CI 0.55-1.00), or both (HR 0.71; 95% CI 0.52-0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02-1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group.
CONCLUSIONS
In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality.
| 1significant effect
|
2,689,169 | 19,445,719 |
BACKGROUND
Intubation of the trachea in the pre-hospital setting may be lifesaving in severely ill and injured patients. However, tracheal intubation is frequently difficult to perform in this challenging environment, is associated with a lower success rate, and failed tracheal intubation constitutes an important cause of morbidity. Novel indirect laryngoscopes, such as the Glidescope and the AWS laryngoscopes may reduce this risk.
METHODS
We compared the efficacy of these devices to the Macintosh laryngoscope when used by 25 Advanced Paramedics proficient in direct laryngoscopy, in a randomized, controlled, manikin study. Following brief didactic instruction with the Glidescope and the AWS laryngoscopes, each participant took turns performing laryngoscopy and intubation with each device, in an easy intubation scenario and following placement of a hard cervical collar, in a SimMan manikin.
RESULTS
Both the Glidescope and the AWS performed better than the Macintosh, and demonstrate considerable promise in this context. The AWS had the least number of dental compressions in all three scenarios, and in the cervical spine immobilization scenario it required fewer maneuvers to optimize the view of the glottis.
CONCLUSION
The Glidescope and AWS devices possess advantages over the conventional Macintosh laryngoscope when used by Advanced Paramedics in normal and simulated difficult intubation scenarios in this manikin study. Further studies are required to extend these findings to the clinical setting.
| 1significant effect
|
1,831,486 | 17,359,519 |
BACKGROUND
Tobacco smoking is a serious risk to health: several therapies are available to assist those who wish to stop. Smokers who approach publicly funded stop-smoking clinics in the UK are currently offered nicotine replacement therapy (NRT) or bupropion, and group behaviour therapy, for which there is evidence of effectiveness. Acupuncture and acupressure are also used to help smokers, though a systematic review of the evidence of their effectiveness was inconclusive. The aim of this pilot project was to determine the feasibility of a study to test acupressure as an adjunct to one anti-smoking treatment currently offered, and to inform the design of the study.
METHODS
An open randomised controlled pilot study was conducted within the six week group programme offered by the Smoking Advice Service in Plymouth, UK. All participants received the usual treatment with NRT and group behavioural therapy, and were randomised into three groups: group A with two auricular acupressure beads, group B with one bead, and group C with no additional therapy. Participants were taught to press the beads when they experienced cravings. Beads were worn in one ear for four weeks, being replaced as necessary. The main outcome measures assessed in the pilot were success at quitting (expired CO < or = 9 ppm), the dose of NRT used, and the rating of withdrawal symptoms using the Mood and Symptoms Scale.
RESULTS
From 49 smokers attending four clinics, 24 volunteered to participate, 19 attended at least once after quitting, and seven remained to the final week. Participants who dropped out reported significantly fewer previous quit attempts, but no other significant differences. Participants reported stimulating the beads as expected during the initial days after quitting, but most soon reduced the frequency of stimulation. The discomfort caused by the beads was minor, and there were no significant side effects. There were technical problems with adhesiveness of the dressing. Reporting of NRT consumption was poor, with much missing data, but reporting of ratings of withdrawal symptom scores was nearly complete. However, these showed no significant changes or differences between groups for any week.
CONCLUSION
Any effects of acupressure on smoking withdrawal, as an adjunct to the use of NRT and behavioural intervention, are unlikely to be detectable by the methods used here and further preliminary studies are required before the hypothesis can be tested.
| 0no significant effect
|
2,892,494 | 20,525,183 |
BACKGROUND
The purpose of this analysis was to evaluate relationships between hospital admission or discharge and scores for symptom or functioning in patients with schizophrenia.
METHODS
Data were from three 52-week open-label extensions of the double-blind pivotal trials of paliperidone extended-release (ER). Symptoms and patient function were measured every 4 weeks using the Personal and Social Performance (PSP) scale and the Positive and Negative Syndrome Scale (PANSS). The intent-to-treat analysis set was defined as open-label patients who had at least one post-baseline PSP and PANSS measurement. Time until first hospitalization was evaluated using the Cox proportional hazard model with categorical time-dependent measures for the PSP (1 to 30, 31 to 70, 71 to 100) or PANSS (< 75, >/= 75 to < 95, >/= 95), as well as age, gender, schizophrenia duration, and country. Similar analyses were performed for time to discharge.
RESULTS
Of the 1,077 enrolled patients, 1,028 (95.5%) met study criteria; of these, 382 (37.2%) were hospitalized at open-label baseline. Compared with patients with PSP >/= 71 group, the hazard for new hospitalization was 8.351 times greater (P = 0.0001) for patients with the poorest functioning (PSP 1 to 30) and 1.977 times greater (P = 0.0295) for patients with PSP of 31-70 compared to the >/= 71 group. The hazard for new hospitalization was 5.457 times greater (P < 0.0001) for patients PANSS >/= 95 and 2.316 times greater (P = 0.0027) for the >/= 75 to < 95 group compared with the < 75 group. For patients hospitalized at baseline, the PANSS >/= 95 patients had a discharge hazard that was 0.456 times lower than for the < 75 patients (P < 0.0001). The hazard for discharge was 0.646 times lower (P = 0.0012) for the PANSS >/= 75 to < 95 group compared with the < 75 group. A patient's country was a significant predictor variable, with US patients being admitted and discharged faster.
CONCLUSIONS
Better functioning or being less symptomatic is associated with reduced risk for hospitalization and greater chance for early discharge. Treatments or programs that reduce symptoms or improve function decrease the risk of hospitalization in community patients or increase the chance of discharge for hospitalized patients.
| 1significant effect
|
4,855,961 | 27,186,550 |
INTRODUCTION
Pregnant women represent a typical group susceptible to dietary and mineral deficiencies. This study was sought to assess the efficacy and safety of various doses of 25-hydroxyvitamin D (25[OH]D) supplementation during pregnancy and ratify the inadequacy of the recommended daily allowance for Vitamin D in vulnerable groups.
MATERIALS AND METHODS
A total of 100 pregnant women were included in this open-label, parallel group, prospective, randomized, and controlled trial. Study subjects were assigned to four treatment groups: Group 1 (n = 26), 1000 IU of Vitamin D daily; Group 2 (n = 21), 30,000 IU of Vitamin D monthly; Group 3 (n = 27), 2000 IU of Vitamin D daily; and Group 4 (n = 26), 60,000 IU Vitamin D monthly. Group 1 and 2 were further analyzed together as Group 1K (1000 IU daily and 30,000 IU monthly), and Group 3 and 4 as Group 2K (2000 IU daily and 60,000 IU monthly). The analysis was done on an intention to treat basis.
RESULTS
A total of 87 patients completed the study; 21 in Group 1, 25 in Group 2, 18 in Group 3, and 23 in Group 4. The levels of 25(OH)D at baseline ranged from 1.3 to 58.0 with a mean of 24.2 ± 15.1 ng/ml. Postsupplementation, 25(OH)D levels ranged from 11.5 to 70.3 with a mean of 40.2 ± 12.2 ng/ml. The postsupplementation levels of 25(OH)D were higher in Group 2K (42.86 ± 12.83) than in Group 1K (36.96 ± 10.56) with P value of 0.023.
CONCLUSION
We concluded that Vitamin D supplementation with 2000 IU/day or 60,000 IU/month is very effective and safe in achieving Vitamin D sufficiency in pregnant women.
| 1significant effect
|
4,359,119 | 25,768,735 |
BACKGROUND
Improvement of the long-term effectiveness of multidisciplinary ortho-paedic rehabilitation (MOR) in the management of chronic non-specific low back pain (CLBP) remains a central issue for health care in Germany. We developed an interprofessional and interdisciplinary, biopsychosocial rehabilitation concept named "PASTOR" to promote self-management in adults with CLBP and compared its effectiveness with the current model of MOR.
METHODS
A multicentre quasi-experimental study with three measurement time points was implemented. 680 adults aged 18 to 65 with CLBP were assed for eligibil-ity in three inpatient rehabilitation centres in Germany. At first the effects of the MOR, with a total extent of 48 hours (control group), were assessed. Thereafter, PASTOR was implemented and evaluated in the same centres (intervention group). It consisted of six interprofessional modules, which were provided on 12 days in fixed groups, with a total extent of 48 hours. Participants were assessed with self-report measures at baseline, discharge, and 12 months for functional ability (primary outcome) using the Hannover Functional Ability Questionnaire (FFbH-R) and vari-ous secondary outcomes (e.g. pain, health status, physical activity, pain coping, pain-related cognitions).
RESULTS
In total 536 participants were consecutively assigned to PASTOR (n=266) or MOR (n=270). At 12 months, complete data of 368 participants was available. The adjusted between-group difference in the FFbH-R at 12 months was 6.58 (95% CI 3.38 to 9.78) using complete data and 3.56 (95% CI 0.45 to 6.67) using available da-ta, corresponding to significant small-to-medium effect sizes of d=0.42 (p<0.001) and d=0.10 (p=0.025) in favour of PASTOR. Further improvements in secondary out-comes were also observed in favour of PASTOR.
CONCLUSION
The interprofessional and interdisciplinary, biopsychosocial rehabilita-tion program PASTOR shows some improvements of the long-term effectiveness of inpatient rehabilitation in the management of adults with CLBP. Further insights into mechanisms of action of complex intervention programs are required.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02056951.
| 1significant effect
|
4,941,128 | 26,424,898 |
INTRODUCTION & OBJECTIVES
Adaptive deep brain stimulation (aDBS) uses feedback from brain signals to guide stimulation. A recent acute trial of unilateral aDBS showed that aDBS can lead to substantial improvements in contralateral hemibody Unified Parkinson's Disease Rating Scale (UPDRS) motor scores and may be superior to conventional continuous DBS in Parkinson's disease (PD). We test whether potential benefits are retained with bilateral aDBS and in the face of concurrent medication.
METHODS
We applied bilateral aDBS in 4 patients with PD undergoing DBS of the subthalamic nucleus. aDBS was delivered bilaterally with independent triggering of stimulation according to the amplitude of β activity at the corresponding electrode. Mean stimulation voltage was 3.0±0.1 volts. Motor assessments consisted of double-blinded video-taped motor UPDRS scores that included both limb and axial features.
RESULTS
UPDRS scores were 43% (p=0.04; Cohen's d=1.62) better with aDBS than without stimulation. Motor improvement with aDBS occurred despite an average time on stimulation (ToS) of only 45%. Levodopa was well tolerated during aDBS and led to further reductions in ToS.
CONCLUSION
Bilateral aDBS can improve both axial and limb symptoms and can track the need for stimulation across drug states.
| 1significant effect
|
4,149,239 | 25,074,318 |
BACKGROUND
Alpha glucosidase inhibitor (GI) attenuates postprandial hyperglycemia (PPH) and reduces the risk of cardiovascular events in patients with impaired glucose tolerance or type 2 diabetes. Dipeptidyl peptidase 4 (DPP-4) inhibitors also attenuate PPH. PPH is one of the factors leading to endothelial dysfunction which is an early event in the pathogenesis of atherosclerosis. Furthermore, DPP-4 inhibitors protect endothelial function through a GLP-1-dependent mechanism. However, the impact of these two types of drugs on endothelial dysfunction in patients with type 2 diabetes has not been fully elucidated. We compared the effects of sitagliptin, a DPP-4 inhibitor, and voglibose, an alpha GI, on endothelial function in patients with diabetes.
METHODS
We conducted a randomized prospective multicenter study in 66 patients with type 2 diabetes who did not achieve the treatment goal with sulfonylurea, metformin or pioglitazone treatment; 31 patients received sitagliptin treatment and 35 patients, voglibose treatment. The flow-mediated dilatation (FMD) of the brachial artery was measured in the fasting state at baseline and after 12 weeks of treatment. The primary endpoint was a change in FMD (ΔFMD) from the baseline to the end of follow-up. The effects of sitagliptin and voglibose on FMD were assessed by ANCOVA after adjustment for the baseline FMD, age, sex, current smoking, diabetes duration and body mass index. Secondary efficacy measures included changes in HbA1c, GIP, GLP-1, C-peptide, CD34, lipid profile, oxidative stress markers, inflammatory markers and eGFR and any adverse events.
RESULTS
ΔFMD was significantly improved after 12 weeks of treatment in both groups, and there was no significant difference in ΔFMD between the two groups. There were no significant differences in changes in HbA1c, GIP, GLP-1, C-peptide, lipid profile, oxidative stress marker, inflammatory marker and eGFR between the two groups. Compared with voglibose, sitagliptin significantly increased the circulating CD34, a marker of endothelial progenitor cells. Adverse events were observed in 5 patients in only the voglibose group (diarrhea 1, nausea 1, edema 2 and abdominal fullness 1).
CONCLUSIONS
Sitagliptin improved endothelial dysfunction just as well as voglibose in patients with type 2 diabetes. Sitagliptin had protective effects on endothelial function without adverse events.
TRIAL REGISTRATION
registered at http://www.umin.ac.jp/ctrj/ under UMIN000003951.
| 0no significant effect
|
4,232,010 | 24,819,710 |
BACKGROUND
Pain is frequent and distressing in people with dementia, but no randomized controlled trials have evaluated the effect of analgesic treatment on pain intensity as a key outcome.
METHODS
Three hundred fifty-two people with dementia and significant agitation from 60 nursing home units were included in this study. These units, representing 18 nursing homes in western Norway, were randomized to a stepwise protocol of treating pain (SPTP) or usual care. The SPTP group received acetaminophen, morphine, buprenorphine transdermal patch and pregabalin for 8 weeks, with a 4-week washout period. Medications were governed by the SPTP and each participant's existing prescriptions. We obtained pain intensity scores from 327 patients (intervention n = 164, control n = 163) at five time points assessed by the primary outcome measure, Mobilization-Observation-Behaviour-Intensity-Dementia-2 (MOBID-2) Pain Scale. The secondary outcome was activities of daily living (ADL). We used a linear intercept mixed model in a two-way repeated measures configuration to assess change over time and between groups.
RESULTS
The SPTP conferred significant benefit in MOBID-2 scores compared with the control group [average treatment effect (ATE) -1.388; p < 0.001] at week 8, and MOBID-2 scores worsened during the washout period (ATE = -0.701; p = 0.022). Examining different analgesic treatments, benefit was conferred to patients receiving acetaminophen compared with the controls at week 2 (ATE = -0.663; p = 0.010), continuing to increase until week 8 (ATE = -1.297; p < 0.001). Although there were no overall improvements in ADL, an increase was seen in the group receiving acetaminophen (ATE = +1.0; p = 0.022).
CONCLUSION
Pain medication significantly improved pain in the intervention group, with indications that acetaminophen also improved ADL function.
| 1significant effect
|
4,823,346 | 26,044,353 |
PURPOSE
Functional treatment is the optimal non-surgical treatment for acute lateral ankle ligament injury (ALALI) in favour of immobilization treatment. There is no single most effective functional treatment (tape, semi-rigid brace or lace-up brace) based on currently available randomized trials.
METHODS
This study is designed as a randomized controlled trial to evaluate the difference in functional outcome after treatment with tape versus semi-rigid versus lace-up ankle support (brace) for grades II and III ALALIs. The Karlsson score and the FAOS were evaluated at 6-month follow-up.
RESULTS
One hundred and ninety-three patients (52% males) were randomized, 66 patients were treated with tape, 58 patients with a semi-rigid brace and 62 patients with a lace-up brace. There were no significant differences in any baseline characteristics between the three groups. Mean age of the patients was 37.3 years (35.1-39.5; SD 15.3). Ninety-five males (49%) were included. One hundred and sixty-one (59 + 50 + 52) patients completed the study through final follow-up; 32% lost at follow-up. In two patients treated with tape support, the treatment was changed to a semi-rigid brace because of dermatomal blisters. Except for the difference in Foot and Ankle Outcome Score sport between the lace-up and the semi-rigid brace, there are no differences in any of the outcomes after 6-month follow-up.
CONCLUSION
The most important finding of current study was that there is no difference in outcome 6 months after treatment with tape, semi-rigid brace and a lace-up brace.
LEVEL OF EVIDENCE
I.
| 0no significant effect
|
2,944,304 | 20,809,967 |
BACKGROUND
Acetylcholinesterase inhibitors cannot rapidly reverse profound neuromuscular block. Sugammadex, a selective relaxant binding agent, reverses the effects of rocuronium and vecuronium by encapsulation. This study assessed the efficacy of sugammadex compared with neostigmine in reversal of profound vecuronium-induced neuromuscular block under sevoflurane anesthesia.
METHODS
Patients aged ≥18 years, American Society of Anesthesiologists class 1-4, scheduled to undergo surgery under general anesthesia were enrolled in this phase III, multicenter, randomized, safety-assessor blinded study. Sevoflurane anesthetized patients received vecuronium 0.1 mg/kg for intubation, with maintenance doses of 0.015 mg/kg as required. Patients were randomized to receive sugammadex 4 mg/kg or neostigmine 70 μg/kg with glycopyrrolate 14 μg/kg at 1-2 post-tetanic counts. The primary efficacy variable was time from start of study drug administration to recovery of the train-of-four ratio to 0.9. Safety assessments included physical examination, laboratory data, vital signs, and adverse events.
RESULTS
Eighty three patients were included in the intent-to-treat population (sugammadex, n = 47; neostigmine, n = 36). Geometric mean time to recovery of the train-of-four ratio to 0.9 was 15-fold faster with sugammadex (4.5 minutes) compared with neostigmine (66.2 minutes; p < 0.0001) (median, 3.3 minutes with sugammadex versus 49.9 minutes with neostigmine). No serious drug-related adverse events occurred in either group.
CONCLUSIONS
Recovery from profound vecuronium-induced block is significantly faster with sugammadex, compared with neostigmine. Neostigmine did not rapidly reverse profound neuromuscular block (Trial registration number: NCT00473694).
| 0no significant effect
|
5,721,317 | 29,290,862 |
BACKGROUND
There is ongoing debate about how to obtain correct rotational alignment in total knee arthroplasty (TKA). Two commonly used techniques are the measured resection (MR) and the gap balancing (GB) technique.
OBJECTIVE
The objective of the present study was to analyze which of these two techniques confers a clinical advantage up to 10 years postoperatively.
METHODS
Two hundred patients were randomized to either MR or GB. The primary outcome was the Knee Society Knee Score (KS) 10 years postoperatively. Secondary outcomes were passive range of motion, the Knee Society Function Score (FS), and the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), along with implant survival. We employed a two one-sided test (TOST) and linear mixed models to assess clinical outcomes.
RESULTS
Mean KS was 82 (95% confidence interval (CI), 80 - 83) and 77 (95% CI, 76 - 79) in the GB and MR group, respectively. The TOST test and linear mixed model both revealed statistical significance (p < 0.001). In addition, GB yielded better postoperative FS and WOMAC. However, between-group differences were consistently small. Implant survival rates at 10 years, with survival for any reason as the endpoint of interest, were 93.7% (95% CI, 86.4% and 97.1%) and 89.8% (95% CI, 81.9% - 94.4%) for the GB group and the MR group, respectively ( p = 0.302).
CONCLUSION
Gap-balancing is a safe and reliable technique. KS for the two study groups at 10 years can be considered equivalent, and the small postoperative advantages may not extend beyond clinical relevance.
| 0no significant effect
|
5,884,950 | 29,966,024 |
Background
Atopic dermatitis (AD) is the most common chronic inflammatory skin disease in infancy with a complex pathology. In adults, the clinical severity of AD has been associated with increases in T helper cell type (Th) 2, Th22, and Th17 serum markers, including high levels of CC chemokine ligand (CCL) 17 and CCL22 chemokines.
Objective
To explore the possible association between serum chemokine levels and AD severity in infants with moderate-to-severe AD and elevated immunoglobulin E (IgE).
Subjects and methods
Serum samples ( n = 41) obtained from a randomized, double-blind, and clinical dietary intervention study were used to study biomarkers in infants with AD. Baseline- and post-intervention samples (4 months) were used, six chemokines and nine ratios thereof were analyzed using Luminex and correlated to AD severity. In the initial study, the infants were randomized to receive extensively hydrolyzed whey-based formula without (control) or with short-chain galacto-oligosaccharides/long-chain fructo-oligosaccharides (9:1) and Bifidobacterium breve M-16V (active).
Results
31 Infants up to 11 months of age, with an objective-SCORAD score (oSCORAD) ≥ 20 and elevated total-IgE and/or specific-IgE levels were included. In time, the median oSCORAD decreased in both groups by -8 (control, p < 0.05; active, p < 0.01). Irrespective of dietary intervention, several changes in Th2 chemokines (CCL17 and CCL22), inflammatory chemokine (CCL20), and the Th1 chemokine, CXC chemokine ligand (CXCL) 9, were detected over time. Overall CCL17 correlated to oSCORAD ( r = 0.446, p < 0.01). After 4 months of dietary intervention, CXCL9 was higher ( p < 0.01) in the active group compared with control [active, 2.33 (1.99-2.89); controls, 1.95 (1.77-2.43) log 10 median (range)]. In addition, a reduction in Th2/Th1 chemokine ratios for CCL17/CXCL9, CCL22/CXCL9, CCL20/CXCL10, and CCL20/CXCL11 was detected associated with the active intervention.
Conclusion
While this study is small and exploratory in nature, these data contribute to immune biomarker profiling and understanding of AD in infants.
| 1significant effect
|
3,816,909 | 24,009,303 |
OBJECTIVE
Genetic variants near IRS1 are associated with features of the metabolic syndrome (MetS). We examined whether genetic variants near IRS1 might modulate the effects of diets varying in fat content on the MetS status in a 2-year weight-loss trial.
RESEARCH DESIGN AND METHODS
Two variants near IRS1, rs1522813 and rs2943641, were genotyped in 738 overweight/obese adults (age 60 ± 9 years; BMI 32.7 ± 3.9 kg/m2) randomly assigned to one of four weight-loss diets (a deficit of 750 kcal/day of caloric intake from baseline) varying in macronutrient contents for 2 years. We compared MetS status of high-fat (40% of caloric intake; n = 370) and low-fat (20% caloric intake; n = 368) diet groups differentiated by genotypes (rs1522813 A-allele carriers and noncarriers and rs2943641T-allele carriers and noncarriers).
RESULTS
Among rs1522813 A-allele carriers, the reversion rates of the MetS were higher in the high-fat diet group than those in the low-fat diet group over the 2-year intervention (P = 0.002), while no significant difference between diet groups was observed among noncarriers (P = 0.27). The genetic modulation on dietary effect was independent of weight changes. The odds ratio (OR) for the 2-year reversion of the MetS was 2.88 (95% CI 1.25-6.67) comparing the high-fat and low-fat diets among rs1522813 A-allele carriers, while the corresponding OR was 0.83 (0.36-1.92) in noncarriers. The variant rs2943641 was not observed to modulate dietary effects on the MetS status.
CONCLUSIONS
Our data suggest that high-fat weight-loss diets might be more effective in the management of the MetS compared with low-fat diets among individuals with the A-allele of the rs1522813 variant near IRS1.
| 1significant effect
|
3,214,443 | 22,090,672 |
BACKGROUND
Hypertension is the most prevalent non-communicable disease causing significant morbidity/mortality through cardiovascular, cerebrovascular, and renal complications.
OBJECTIVES
This community-based study tested the efficacy of non-pharmacological interventions in preventing/controlling hypertension.
MATERIALS AND METHODS
This is a cross-over randomized controlled trial (RCT) of the earlier RCT (2007) of non-pharmacological interventions in hypertension, conducted in the urban service area of our Institute. The subjects, prehypertensive and hypertensive young adults (98 subjects: 25, 23, 25, 25 in four groups) were randomly allotted into a group that he/she had not belonged to in the earlier RCT: Control (New Group I), Physical Exercise (NG II)-brisk walking for 50 to 60 minutes, three to four days/week, Salt Intake Reduction (NG III) to at least half of their previous intake, Yoga (NG IV) for 30 to 45 minutes/day, five days/week. Blood pressure was measured before and after eight weeks of intervention. Analysis was by ANOVA with a Games-Howell post hoc test.
RESULTS
Ninety-four participants (25, 23, 21, 25) completed the study. All three intervention groups showed significant reduction in BP (SBP/DBP mmHg: 5.3/6.0 in NG II, 2.5/2.0 in NG III, and 2.3/2.4 in NG IV, respectively), while the Control Group showed no significant difference. Persistence of significant reduction in BP in the three intervention groups after cross-over confirmed the biological plausibility of these non-pharmacological interventions. This study reconfirmed that physical exercise was more effective than Salt Reduction or Yoga. Salt Reduction, and Yoga were equally effective.
CONCLUSION
Physical exercise, salt intake reduction, and yoga are effective non-pharmacological methods for reducing blood pressure in young pre-hypertensive and hypertensive adults.
| 1significant effect
|
5,015,408 | 27,451,467 |
BACKGROUND
Many patients with atrial fibrillation (AF) do not receive oral anticoagulants (OAC) for the prevention of stroke and systemic embolism. We aimed to improve the prescription of (OAC) among hospitalized patients with AF.
METHODS AND RESULTS
We developed a computer-based electronic alert system for identifying hospitalized OAC-naïve patients with AF. The alert system contained a CHA2DS2-VASc score calculation tool and provided recommendations for OAC prescription. The alert system was tested in a 1:1 randomized controlled trial at the University Hospital Bern: Patients with suspected AF without an active prescription order were allocated to an alert group in which an alert was issued in the electronic patient chart and order entry system or to a control group in which no alert was issued. The primary end point was the rate of adequate OAC prescription at hospital discharge, defined as prescription in OAC-naïve men and women with CHA2DS2-VASc score ≥1 and ≥2, respectively. Overall, 889 OAC-naïve patients (455 from the alert group and 434 from the control group) were eligible for analysis. Although the CHA2DS2-VASc score module was used in only 48 (10.5%) patients from the alert group, 100 (22.0%) patients from the alert group versus 69 (15.9%) from the control group received adequate OAC prescription (relative risk 1.38; P=0.021). OAC or antiplatelet therapy was prescribed in 325 (71.4%) patients from the alert group versus 271 (62.4%) from the control group (P=0.004).
CONCLUSIONS
Versus standard care, the alert system modestly improved OAC prescription among consecutive hospitalized AF patients.
CLINICAL TRIAL REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02455102.
| 1significant effect
|
5,471,755 | 28,626,468 |
BACKGROUND AND AIM
Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person's age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients.
METHODS
Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results.
RESULTS
Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were -2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were -2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group ( p < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal.
CONCLUSION
MLC601 has shown promising efficacy and acceptable AEs in MCI patients.
| 1significant effect
|
4,823,408 | 27,066,204 |
BACKGROUND
Neck flexion by head elevation using an 8 to 10 cm thick pillow and head extension has been suggested to align the laryngeal, pharyngeal and oral axis and facilitate tracheal intubation. Presently, the laryngeal view and discomfort for tracheal intubation were evaluated according to two different degrees of head elevation in adult patients.
METHODS
This prospective randomized, controlled study included 50 adult patients aged 18 to 90 years. After induction of anesthesia, the Cormack Lehane grade was evaluated in 25 patients using a direct laryngoscope while the patient's head was elevated with a 4 cm pillow (4 cm group) and then an 8 cm pillow (8 cm group). In the other 25 patients, the grades were evaluated in the opposite sequence and tracheal intubation was performed. The success rate and anesthesiologist's discomfort score for tracheal intubation, and laryngeal, pharyngeal and oral axes were assessed.
RESULTS
There were no differences in the laryngeal view and success rate for tracheal intubation between the two groups. The discomfort score during tracheal intubation was higher in the 8 cm group when the patient's head was elevated 4 cm first and then 8 cm. The alignment of laryngeal, pharyngeal and oral axes were not different between the two degrees of head elevation.
CONCLUSIONS
A pillow of 8 cm height did not improve laryngeal view and alignment of airway axes but increased the anesthesiologist discomfort, compared to a pillow of 4 cm height, during tracheal intubation in adult patients.
| 0no significant effect
|
3,043,099 | 21,364,957 |
BACKGROUND
Young adult Mexican Americans (MA) exhibit lower insulin sensitivity (Si) than nonHispanic whites (NHW), even when controlling for fitness and adiposity. It is unclear if MA are as responsive to the same lifestyle intervention as NHW.
OBJECTIVE
We developed a model to examine cardiometabolic plasticity (i.e., changes in Si and plasma lipids) in MA compared to NHW adults in response to a diet-exercise intervention.
DESIGN
Sedentary subjects (20 NHW: 11F, 9M, 23.0 y, 25.5 kg/m(2); 17 MA: 13F, 4M, 22.7 y, 25.4 kg/m(2)) consumed their habitual diets and remained sedentary for 7 days, after which fasting blood samples were obtained, and a 3-h intravenous glucose tolerance test (IVGTT) was performed with the insulin area under the curve (IAUC) used to estimate Si. Subjects then completed a 7-day diet/exercise intervention (diet: low saturated fat, low added sugar, high fiber; exercise: cycling, six total sessions lasting 40-45 min/session at 65% VO(2) max). Pre-intervention tests were repeated.
RESULTS
Pre intervention IAUC was 28% higher (p<0.05) in MA (IAUC pre = 2298 µU*180 min/mL) than in NHW (IAUC = 1795 µU*180 min/mL). Following the intervention, there was a significant reduction in IAUC in MA (29%) and NHW (32%), however, the IAUC remained higher (p<0.05) for MA (post = 1635 µU*180 min/mL) than for NHW (post = 1211 µU*180 min/mL). Pre test plasma lipids were not different in MA compared to NHW. Plasma cholesterol and TG concentrations significantly improved in both groups, but concentrations of low density lipoprotein-cholesterol and small dense LDL particles significantly improved only in the NHW.
CONCLUSION
With a short-term diet-exercise intervention, the magnitude of improvements in Si and serum cholesterol and TG in Hispanics are similar to those in NHW. However, because at the outset MA were less insulin sensitive compared to NHW, within the short timeframe studied the ethnic gap in insulin sensitivity remained.
| 1significant effect
|
5,588,713 | 28,877,711 |
BACKGROUND
Inhalation of particulate matter, as part of air pollution, is associated with increased morbidity and mortality. Nanoparticles (< 100 nm) are likely candidates for triggering inflammatory responses and activation of coagulation pathways because of their ability to enter lung cells and pass bronchial mucosa. We tested the hypothesis that bronchial segmental instillation of carbon nanoparticles causes inflammation and activation of coagulation pathways in healthy humans in vivo.
METHODS
This was an investigator-initiated, randomized controlled, dose-escalation study in 26 healthy males. Participants received saline (control) in one lung segment and saline (placebo) or carbon nanoparticles 10 μg, 50 μg, or 100 μg in the contra-lateral lung. Six hours later, blood and bronchoalveolar lavage fluid (BALF) was collected for inflammation and coagulation parameters.
RESULTS
There was a significant dose-dependent increase in blood neutrophils (p = 0.046) after challenge with carbon nanoparticles. The individual top-dose of 100 μg showed a significant (p = 0.05) increase in terms of percentage neutrophils in blood as compared to placebo.
CONCLUSIONS
This study shows a dose-dependent effect of bronchial segmental challenge with carbon nanoparticles on circulating neutrophils of healthy volunteers. This suggests that nanoparticles in the respiratory tract induce systemic inflammation.
TRIAL REGISTRATION
Dutch Trial Register no. 2976. 11 July 2011. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2976.
| 1significant effect
|
3,990,364 | 24,748,783 |
BACKGROUND
Aging-related reduced spinal mobility can interfere with the execution of important functional skills and activities in elderly women. Although several studies have shown positive outcomes in response to spinal flexibility training programs, little is known about the management of sets and repetitions in training protocols. The purpose of this study was to investigate the effects of an 8-week specific and standardized flexibility training program on the range of spinal motion in elderly women.
METHODS
PARTICIPANTS WERE RECRUITED IN A SENIOR CENTER OF PALERMO AND RANDOMLY ASSIGNED IN TWO GROUPS: trained group (TG) and control group (CG), which included 19 and 18 women, respectively. TG was trained for 8 weeks at two sessions/week. In particular, every session included three phases: warm up (~10 minutes), central period (~50 minutes), and cool down (~10 minutes). CG did not perform any physical activity during the experimental period. Spinal ranges of motion (ROM) were measured from neutral standing position to maximum bending position and from neutral standing position to maximum extension position before and after the experimental period, using a SpinalMouse® device (Idiag, Volkerswill, Switzerland).
RESULTS
After the training period, TG showed an increase in spinal inclination by 16.4% (P<0.05), in sacral/hip ROM by 29.2% (P<0.05), and in thoracic ROM by 22.5% (P>0.05) compared with CG from maximum extension position to maximum bending position. We did not observe any significant difference in TG's lumbar ROM compared with CG after the training period (P>0.05).
CONCLUSION
We found that an 8-week flexibility training program improved ROMs of the spine in elderly women. The training protocol appeared to be practicable for active elderly people with autonomy and the capability for self-care.
| 0no significant effect
|
3,459,547 | 23,055,763 |
BACKGROUND
The long-term follow-up of chronic urticaria (CU) is important to ensure the adequate treatment of patients. Olopatadine hydrochloride is one of the second-generation nonsedating antihistamines.
METHODS
This study was designed to assess the optimal dose of olopatadine to suppress symptoms of chronic urticarial itch in well-controlled patients. After CU patients were treated with 10 mg olopatadine, patients having a visual analog scale (VAS) itch score of less than 20 were randomly allocated into one of three groups: 10 mg/day (n = 35), 5 mg/day (n = 30), or no medication (n = 32).
RESULTS
The suppressive effects of both the 5 mg and 10 mg olopatadine treatments on the VAS itch score were more significant and longer lasting over a period of 4 weeks than the no-medication treatment. Both the 5-mg group and the 10-mg group showed improved urticarial symptoms and maintained their VAS itch score within normal limits compared to the no-medication group. The differences between the 5-mg and 10-mg groups were not significant.
CONCLUSION
These results demonstrate that treatment with olopatadine at a dose of 5 mg once daily is effective and safe for the management and prevention of CU symptoms for itch in well-controlled patients.
| 1significant effect
|
4,327,560 | 25,479,584 |
OBJECTIVE
The aim of this study was to evaluate efficacy and safety of everolimus in patients with pancreatic neuroendocrine tumors (pNET) by prior chemotherapy use in the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3).
METHODS
Patients with advanced, progressive, low- or intermediate-grade pNET were prospectively stratified by prior chemotherapy use and World Health Organization performance status and were randomly assigned (1:1) to everolimus 10 mg/d (n = 207) or placebo (n = 203).
RESULTS
Of the 410 patients, 204 (50%) were naive to chemotherapy (chemonaive). Baseline characteristics were similar for patients with or without prior chemotherapy. Everolimus significantly prolonged median progression-free survival regardless of prior chemotherapy use (prior chemotherapy: 11.0 vs 3.2 months; hazard ratio, 0.34; 95% confidence interval, 0.25-0.48; P < 0.0001) (chemonaive: 11.4 vs 5.4 months; hazard ratio, 0.42; 95% confidence interval, 0.29-0.60; P < 0.0001). Stable disease was the best overall response in 73% of everolimus-treated patients (151/207). The most common drug-related adverse events included stomatitis (60%-69%), rash (47%-50%), and diarrhea (34%).
CONCLUSIONS
As more treatment options become available, it is important to consider the goals of treatment and to identify patients who would potentially benefit from a specific therapy. Findings from this planned subgroup analysis suggest the potential for first-line use of everolimus in patients with advanced pNET.
| 1significant effect
|
3,293,068 | 22,257,640 |
BACKGROUND
Sport drinks are ubiquitous within the recreational and competitive fitness and sporting world. Most are manufactured and artificially flavored carbohydrate-electrolyte beverages. Recently, attention has been given to coconut water, a natural alternative to manufactured sport drinks, with initial evidence indicating efficacy with regard to maintaining hydration. We compared coconut water and a carbohydrate-electrolyte sport drink on measures of hydration and physical performance in exercise-trained men.
METHODS
Following a 60-minute bout of dehydrating treadmill exercise, 12 exercise-trained men (26.6 ± 5.7 yrs) received bottled water (BW), pure coconut water (VitaCoco®: CW), coconut water from concentrate (CWC), or a carbohydrate-electrolyte sport drink (SD) [a fluid amount based on body mass loss during the dehydrating exercise] on four occasions (separated by at least 5 days) in a random order, single blind (subject and not investigators), cross-over design. Hydration status (body mass, fluid retention, plasma osmolality, urine specific gravity) and performance (treadmill time to exhaustion; assessed after rehydration) were determined during the recovery period. Subjective measures of thirst, bloatedness, refreshed, stomach upset, and tiredness were also determined using a 5-point visual analog scale.
RESULTS
Subjects lost approximately 1.7 kg (~2% of body mass) during the dehydrating exercise and regained this amount in a relatively similar manner following consumption of all conditions. No differences were noted between coconut water (CW or CWC) and SD for any measures of fluid retention (p > 0.05). Regarding exercise performance, no significant difference (p > 0.05) was noted between BW (11.9 ± 5.9 min), CW (12.3 ± 5.8 min), CWC (11.9 ± 6.0 min), and SD (12.8 ± 4.9 min). In general, subjects reported feeling more bloated and experienced greater stomach upset with the CW and CWC conditions.
CONCLUSION
All tested beverages are capable of promoting rehydration and supporting subsequent exercise. Little difference is noted between the four tested conditions with regard to markers of hydration or exercise performance in a sample of young, healthy men. Additional study inclusive of a more demanding dehydration protocol, as well as a time trial test as the measure of exercise performance, may more specifically determine the efficacy of these beverages on enhancing hydration and performance following dehydrating exercise.
| 0no significant effect
|
3,546,025 | 23,231,757 |
BACKGROUND
Excess adipose tissue and sarcopenia presents a multifaceted clinical challenge that promotes morbidity and mortality in the obese, elderly population. Unfortunately, the mortality risks of muscle loss may outweigh the potential benefits of weight loss in the elderly. We have previously demonstrated the effectiveness of whey protein and essential amino acids towards the preservation of lean tissue, even under the conditions of strict bedrest in the elderly.
METHODS
In the context of caloric restriction-based weight loss, we hypothesized that a similar formulation given as a meal replacement (EAAMR) would foster the retention of lean tissue through an increase in the skeletal muscle fractional synthesis rate (FSR). We also proposed that EAAMR would promote the preferential loss of adipose tissue through the increased energy cost of skeletal muscle FSR. We recruited and randomized 12 elderly individuals to an 8 week, caloric restriction diet utilizing equivalent caloric meal replacements (800 kcal/day): 1) EAAMR or a 2) competitive meal replacement (CMR) in conjunction with 400 kcal of solid food that totaled 1200 kcal/day designed to induce 7% weight loss. Combined with weekly measurements of total body weight and body composition, we also measured the acute change in the skeletal muscle FSR to EAAMR and CMR.
RESULTS
By design, both groups lost ~7% of total body weight. While EAAMR did not promote a significant preservation of lean tissue, the reduction in adipose tissue was greater in EAAMR compared to CMR. Interestingly, these results corresponded to an increase in the acute skeletal muscle protein FSR.
CONCLUSION
The provision of EAAMR during caloric restriction-induced weight loss promotes the preferential reduction of adipose tissue and the modest loss of lean tissue in the elderly population.
| 0no significant effect
|
4,129,110 | 25,086,646 |
BACKGROUND
Understanding exercise participation for overweight and obese adults is critical for preventing comorbid conditions. Group-based high-intensity functional training (HIFT) provides time-efficient aerobic and resistance exercise at self-selected intensity levels which can increase adherence; behavioral responses to HIFT are unknown. This study examined effects of HIFT as compared to moderate-intensity aerobic and resistance training (ART) on exercise initiation, enjoyment, adherence, and intentions.
METHODS
A stratified, randomized two-group pre-test posttest intervention was conducted for eight weeks in 2012 with analysis in 2013. Participants (n = 23) were stratified by median age (< or ≥ 28) and body mass index (BMI; < or ≥ 30.5). Participants were physically inactive with an average BMI of 31.1 ± 3.5 kg/m2, body fat percentage of 42.0 ± 7.4%, weight of 89.5 ± 14.2 kg, and ages 26.8 ± 5.9 years. Most participants were white, college educated, female, and married/engaged. Both groups completed 3 training sessions per week. The ART group completed 50 minutes of moderate aerobic exercise each session and full-body resistance training on two sessions per week. The HIFT group completed 60-minute sessions of CrossFit™ with actual workouts ranging from 5-30 minutes. Participants completed baseline and posttest questionnaires indicating reasons for exercise initiation (baseline), exercise enjoyment, and exercise intentions (posttest). Adherence was defined as completing 90% of exercise sessions. Daily workout times were recorded.
RESULTS
Participants provided mostly intrinsic reasons for exercise initiation. Eighteen participants adhered (ART = 9, 81.8%; HIFT = 9, 75%). HIFT dropouts (p = .012) and ART participants (p = .009) reported lower baseline exercise enjoyment than HIFT participants, although ART participants improved enjoyment at posttest (p = .005). More HIFT participants planned to continue the same exercise than ART participants (p = .002). No significant changes in BMI or body composition were found. Workouts were shorter for HIFT than ART (p < .001).
CONCLUSIONS
HIFT participants spent significantly less time exercising per week, yet were able to maintain exercise enjoyment and were more likely to intend to continue. High-intensity exercise options should be included in public health interventions.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: http://NCT02185872. Registered 9 July 2014.
| 1significant effect
|
3,466,131 | 22,748,098 |
BACKGROUND
The aim was to compare two standard chemotherapy regimens combined with bevacizumab as first-line treatment in patients with metastatic colorectal cancer.
METHODS
Patients previously untreated for metastatic disease were randomized in: group A (irinotecan, capecitabine, bevacizumab, every 3 weeks; XELIRI-bevacizumab) and group B (irinotecan, leucovorin, fluorouracil, bevacizumab, every 2 weeks; FOLFIRI-bevacizumab). Primary endpoint was progression-free survival (PFS). Plasma concentrations of nitric oxide, osteopontin, TGF-β1 and VEGF-A were measured at baseline and during treatment.
RESULTS
Among 285 eligible patients, 143 were randomized to group A and 142 to group B. Fifty-five patients (38.5%) in group A and 57 (40.1%) in group B responded (p = 0.81). After a median follow-up of 42 months, median PFS was 10.2 and 10.8 months (p = 0.74), while median OS was 20.0 and 25.3 months (p = 0.099), for groups A and B, respectively. Most frequent grade 3-4 toxicities (group A vs group B) were neutropenia (13% vs 22%, p = 0.053) and diarrhea (19% vs 11%, p = 0.082). Baseline plasma osteopontin concentrations demonstrated prognostic significance for both PFS and OS.
CONCLUSIONS
This trial did not show significant differences in efficacy between the groups. However, the toxicity profile was different. Baseline plasma osteopontin concentrations demonstrated independent prognostic significance. (
REGISTRATION NUMBER
ACTRN12610000270011).
| 0no significant effect
|
4,260,384 | 25,565,752 |
BACKGROUND
The aim of this study is to compare and evaluate the clinical outcome of the envelope-type of coronally advanced flap (CAF) alone versus envelope type of coronally advanced flap plus type I collagen membrane (NEOMEM) in the treatment of multiple buccal gingival recessions, using the split mouth study.
MATERIALS AND METHODS
Ten patients in the age group of 20-50 years showing bilateral gingival recessions were treated. The defects in each patient were randomly assigned as Group A, which were treated with the envelope type of CAF, and those in Group B were treated with envelope type of CAF along with the Type I collagen membrane (NEOMEM). The recession depth (RD), probing depth (PD), clinical attachment level (CAL), and width of the keratinized tissue (KT) were measured at baseline, at three and six month intervals.
RESULTS
Forty-six Miller's class I and II gingival recessions were treated. In the CAF + Type I collagen membrane (NEOMEM)-treated (Group B) sites the baseline gingival recession was 2.34 ± 0.48 mm, while in the CAFtreated (Group A) sites it was 2.52 ± 0.84 mm. Both the treatments resulted in significant recession depth reduction (P < 0.001), but the reduction was significantly greater (P < 0.01) for Group B than Group A. The probing depth changes were significant (P < 0.01) for both groups, but the difference was nonsignificant. Similarly, a significant gain of CAL was seen in Group B (2.23 ± 0.75 mm, P < 0.001) as well as in group A (1.60 ± 0.86 mm, P < 0.001) showing a significant difference (P < 0.01) between the two groups. The width of keratinized tissue was also significantly (P < 0.001) increased in both groups, but the increase was significantly greater (P < 0.001) in group B (2.30 ± 1.06 mm) than in group A (1.21 ± 0.67 mm).
CONCLUSION
The envelope type of CAF along with Type I collagen membrane (NEOMEM) was more effective than envelope type of CAF alone, in producing root coverage in multiple gingival recession defects, associated with gain in CAL as also in the width of KT.
| 0no significant effect
|
2,613,135 | 18,959,779 |
BACKGROUND
This phase I study was designed to determine the bioavailability and bioequivalence of 400 mg Eudorlin extra* (Ibuprofen) in comparison to two reference formulations (400 mg Nurofen forte and 400 mg Migränin after single dose administration under fasting conditions in healthy subjects. Therefore the design of a randomized, open label, multiple sequence cross-over study with a wash-out period of 7-10 days was used.
RESULTS
AUC(0-t)(last) and AUC(0-infinity) (90%CI) were within the 80 to 125% interval required for bioequivalence as stipulated in the current regulations of the EMEA. Cmax (90%CI) was within the EMEA acceptance range of 75 to 133%. Detailed analyses showed that Cmax of Eudorlin extra was higher than that of Nurofen forte (36.62 vs. 32.92 microg/ml; p = 0.0014) and that of Migränin (35.94 vs. 30.87 microg/ml; p < 0.0001). The time to maximum plasma concentration (tmax) was shorter with Eudorlin extra than with Nurofen forte (1.14 vs. 1.82 h; p < 0.0001) and Migränin (1.13 vs. 1.78 h; p = 0.0031). Only 1 patient experienced an adverse with possible relation to the study drug taking Migränin.
CONCLUSION
It is concluded that Eudorlin extra is bioequivalent to the two reference preparations Nurofen forte and Migränin for both, the extent and the rate of absorption, after single dose administration in healthy volunteers according to the guidance of the EMEA. Within this frame, peak plasma concentrations are however reached earlier and peaks are higher compared to the reference products. * Eudorlin extra may have different brand names in different countries.
| 1significant effect
|
4,493,951 | 26,152,218 |
BACKGROUND
Low-dose haloperidol is known to be effective for the prevention of postoperative nausea and vomiting (PONV). However, precise dose-response studies have not been completed, especially in patients at high risk for PONV who require combination therapy. This study sought to identify which dose of haloperidol 1mg or 2mg could be combined with dexamethasone without adverse effects in high-risk patients undergoing gynecological laparoscopic surgery.
METHODS
Female adults (n = 150) with three established PONV risk factors based on Apfel's score were randomized into one of three study groups. At the end of anesthesia, groups H0, H1, and H2 were given intravenous (IV) saline, haloperidol 1 mg, and haloperidol 2 mg, respectively. All patients were given dexamethasone 5 mg during the induction of anesthesia. The overall early (0-2 h) and late (2-24 h) incidences of nausea, vomiting, rescue anti-emetic administration, pain, and adverse effects (cardiac arrhythmias and extrapyramidal effects) were assessed postoperatively. The sedation score was recorded in the postanesthesia care unit (PACU).
RESULTS
The total incidence of PONV over 24 h was significantly lower in groups H1 (29 %) and H2 (24 %) than in group H0 (54 %; P = 0.003), but there was no significant difference between groups H1 and H2. In the PACU, group H2 had a higher sedation score than groups H1 and H0 (P < 0.001).
CONCLUSIONS
For high-risk PONV patients undergoing gynecological laparoscopic surgery, when used with dexamethasone, 1-mg haloperidol was equally effective as 2 mg in terms of preventing PONV with the less sedative effect.
TRIAL REGISTRATION
ClinicalTrials.gov ( NCT01639599 ).
| 1significant effect
|
4,080,584 | 24,966,134 |
BACKGROUND
This study evaluated the effectiveness of a school-community program on Health-Related Quality of Life (HRQoL; the primary outcome), physical activity (PA), and potential mediators of PA among adolescent girls living in low-socioeconomic rural/regional settings.
METHOD
The study was a cluster-randomized controlled trial. Twelve communities with the requisite sports clubs and facilities were paired according to relevant criteria; one of each pair was randomly assigned to the intervention or control condition. Eight schools per condition were randomly selected from these communities and the intervention was conducted over one school year (2011). Female students in grades 7-9 in intervention schools participated in two 6-session PA units - a sport unit (football or tennis) and a recreational unit (leisure centre-based). These were incorporated into physical education (PE) curriculum and linked to PA opportunities for participation outside school. Students were surveyed at baseline and endpoint, self-reporting impact on primary and secondary outcome measures (HRQoL, PA) and PA mediators (e.g. self-efficacy). Linear mixed models for two-group (intervention, control) and three-group (completers, non-completers, control) analyses were conducted with baseline value, age and BMI as covariates, group as a fixed effect and school as random cluster effect.
RESULTS
Participants completing baseline and endpoint measures included: 358 intervention (baseline response rate 33.7%, retention rate 61.3%) and 256 control (14.1% and 84.0%). Adjustment for age and BMI made no substantive difference to outcomes, and there were no cluster effects. For HRQoL, after adjustment for baseline scores, the intervention group showed significantly higher scores on all three PedsQL scores (physical functioning: M ± SE = 83.9 ± 0.7, p = .005; psychosocial: 79.9 ± 0.8, p = .001; total score: 81.3 ± 0.7, p = .001) than the control group (80.9 ± 0.8; 76.1 ± 0.9 and 77.8 ± 0.8). The three-group analysis found intervention non-completers had significantly higher PedsQL scores (84.0 ± 0.8, p = .021; 80.4 ± 0.9, p = .003; 81.7 ± 0.8, p = .002;) than controls (80.9 ± 0.8, 76.1 ± 0.9 and 77.8 ± 0.8). There were no significant differences for any PA measure. Intervention completers had significantly higher scores than non-completers and controls for some mediator variables (e.g. self-efficacy, behavioural control).
CONCLUSION
Positive outcomes were achieved from a modest school-community linked intervention. The school component contributed to maintaining HRQoL; students who completed the community component derived a range of intra-personal and inter-personal benefits.
TRIAL REGISTRATION
ACTRN12614000446662. April 30th 2014.
| 1significant effect
|
4,907,437 | 27,299,859 |
BACKGROUND
Chronic musculoskeletal pain is the leading cause of disability worldwide. The effectiveness of pharmacological treatments for chronic pain is often limited, and there is growing concern about the adverse effects of these treatments, including opioid dependence. Nonpharmacological approaches to chronic pain may be an attractive alternative or adjunctive treatment. We describe the effectiveness of a novel, theoretically based group pain management support intervention for chronic musculoskeletal pain.
METHODS AND FINDINGS
We conducted a multi-centre, pragmatic, randomised, controlled effectiveness and cost-effectiveness (cost-utility) trial across 27 general practices and community musculoskeletal services in the UK. We recruited 703 adults with musculoskeletal pain of at least 3 mo duration between August 1, 2011, and July 31, 2012, and randomised participants 1.33:1 to intervention (403) or control (300). Intervention participants were offered a participative group intervention (COPERS) delivered over three alternate days with a follow-up session at 2 wk. The intervention introduced cognitive behavioural approaches and was designed to promote self-efficacy to manage chronic pain. Controls received usual care and a relaxation CD. The primary outcome was pain-related disability at 12 mo (Chronic Pain Grade [CPG] disability subscale); secondary outcomes included the CPG disability subscale at 6 mo and the following measured at 6 and 12 mo: anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), pain acceptance (Chronic Pain Acceptance Questionnaire), social integration (Health Education Impact Questionnaire social integration and support subscale), pain-related self-efficacy (Pain Self-Efficacy Questionnaire), pain intensity (CPG pain intensity subscale), the census global health question (2011 census for England and Wales), health utility (EQ-5D-3L), and health care resource use. Analyses followed the intention-to-treat principle, accounted for clustering by course in the intervention arm, and used multiple imputation for missing or incomplete primary outcome data. The mean age of participants was 59.9 y, with 81% white, 67% female, 23% employed, 85% with pain for at least 3 y, and 23% on strong opioids. Symptoms of depression and anxiety were common (baseline mean HADS scores 7.4 [standard deviation 4.1] and 9.2 [4.6], respectively). Overall, 282 (70%) intervention participants met the predefined intervention adherence criterion. Primary outcome data were obtained from 88% of participants. There was no significant difference between groups in pain-related disability at 6 or 12 mo (12 mo: difference -1.0, intervention versus control, 95% CI -4.9 to 3.0), pain intensity, or the census global health question. Anxiety, depression, pain-related self-efficacy, pain acceptance, and social integration were better in the intervention group at 6 mo; at 12 mo, these differences remained statistically significant only for depression (-0.7, 95% CI -1.2 to -0.2) and social integration (0.8, 95% CI 0.4 to 1.2). Intervention participants received more analgesics than the controls across the 12 mo. The total cost of the course per person was £145 (US$214). The cost-utility analysis showed there to be a small benefit in terms of quality-adjusted life years (QALYs) (0.0325, 95% CI -0.0074 to 0.0724), and on the cost side the intervention was a little more expensive than usual care (i.e., £188 [US$277], 95% CI -£125 [-US$184] to £501 [US$738]), resulting in an incremental cost-effectiveness ratio of £5,786 (US$8,521) per QALY. Limitations include the fact that the intervention was relatively brief and did not include any physical activity components.
CONCLUSIONS
While the COPERS intervention was brief, safe, and inexpensive, with a low attrition rate, it was not effective for reducing pain-related disability over 12 mo (primary outcome). For secondary outcomes, we found sustained benefits on depression and social integration at 6 and 12 mo, but there was no effect on anxiety, pain-related self-efficacy, pain acceptance, pain intensity, or the census global health question at 12 mo. There was some evidence that the intervention may be cost-effective based on a modest difference in QALYs between groups.
TRIAL REGISTRATION
ISRCTN Registry 24426731.
| 0no significant effect
|
5,124,485 | 27,686,946 |
BACKGROUND
Outcome of low-grade glioma (WHO grade II) is highly variable, reflecting molecular heterogeneity of the disease. We compared two different, single-modality treatment strategies of standard radiotherapy versus primary temozolomide chemotherapy in patients with low-grade glioma, and assessed progression-free survival outcomes and identified predictive molecular factors.
METHODS
For this randomised, open-label, phase 3 intergroup study (EORTC 22033-26033), undertaken in 78 clinical centres in 19 countries, we included patients aged 18 years or older who had a low-grade (WHO grade II) glioma (astrocytoma, oligoastrocytoma, or oligodendroglioma) with at least one high-risk feature (aged >40 years, progressive disease, tumour size >5 cm, tumour crossing the midline, or neurological symptoms), and without known HIV infection, chronic hepatitis B or C virus infection, or any condition that could interfere with oral drug administration. Eligible patients were randomly assigned (1:1) to receive either conformal radiotherapy (up to 50·4 Gy; 28 doses of 1·8 Gy once daily, 5 days per week for up to 6·5 weeks) or dose-dense oral temozolomide (75 mg/m 2 once daily for 21 days, repeated every 28 days [one cycle], for a maximum of 12 cycles). Random treatment allocation was done online by a minimisation technique with prospective stratification by institution, 1p deletion (absent vs present vs undetermined), contrast enhancement (yes vs no), age (<40 vs ≥40 years), and WHO performance status (0 vs ≥1). Patients, treating physicians, and researchers were aware of the assigned intervention. A planned analysis was done after 216 progression events occurred. Our primary clinical endpoint was progression-free survival, analysed by intention-to-treat; secondary outcomes were overall survival, adverse events, neurocognitive function (will be reported separately), health-related quality of life and neurological function (reported separately), and correlative analyses of progression-free survival by molecular markers (1p/19q co-deletion, MGMT promoter methylation status, and IDH1/IDH2 mutations). This trial is closed to accrual but continuing for follow-up, and is registered at the European Trials Registry, EudraCT 2004-002714-11, and at ClinicalTrials.gov, NCT00182819.
FINDINGS
Between Sept 23, 2005, and March 26, 2010, 707 patients were registered for the study. Between Dec 6, 2005, and Dec 21, 2012, we randomly assigned 477 patients to receive either radiotherapy (n=240) or temozolomide chemotherapy (n=237). At a median follow-up of 48 months (IQR 31-56), median progression-free survival was 39 months (95% CI 35-44) in the temozolomide group and 46 months (40-56) in the radiotherapy group (unadjusted hazard ratio [HR] 1·16, 95% CI 0·9-1·5, p=0·22). Median overall survival has not been reached. Exploratory analyses in 318 molecularly-defined patients confirmed the significantly different prognosis for progression-free survival in the three recently defined molecular low-grade glioma subgroups (IDHmt, with or without 1p/19q co-deletion [IDHmt/codel], or IDH wild type [IDHwt]; p=0·013). Patients with IDHmt/non-codel tumours treated with radiotherapy had a longer progression-free survival than those treated with temozolomide (HR 1·86 [95% CI 1·21-2·87], log-rank p=0·0043), whereas there were no significant treatment-dependent differences in progression-free survival for patients with IDHmt/codel and IDHwt tumours. Grade 3-4 haematological adverse events occurred in 32 (14%) of 236 patients treated with temozolomide and in one (<1%) of 228 patients treated with radiotherapy, and grade 3-4 infections occurred in eight (3%) of 236 patients treated with temozolomide and in two (1%) of 228 patients treated with radiotherapy. Moderate to severe fatigue was recorded in eight (3%) patients in the radiotherapy group (grade 2) and 16 (7%) in the temozolomide group. 119 (25%) of all 477 patients had died at database lock. Four patients died due to treatment-related causes: two in the temozolomide group and two in the radiotherapy group.
INTERPRETATION
Overall, there was no significant difference in progression-free survival in patients with low-grade glioma when treated with either radiotherapy alone or temozolomide chemotherapy alone. Further data maturation is needed for overall survival analyses and evaluation of the full predictive effects of different molecular subtypes for future individualised treatment choices.
FUNDING
Merck Sharpe & Dohme-Merck & Co, Canadian Cancer Society, Swiss Cancer League, UK National Institutes of Health, Australian National Health and Medical Research Council, US National Cancer Institute, European Organisation for Research and Treatment of Cancer Cancer Research Fund.
| 0no significant effect
|
2,748,072 | 19,732,431 |
BACKGROUND
After its introduction, laparoscopic cholecystectomy rapidly expanded around the world and was accepted the procedure of choice by consensus. However, analysis of evidence shows no difference regarding primary outcome measures between laparoscopic and small-incision cholecystectomy. In absence of clear clinical benefit it may be interesting to focus on the resource use associated with the available techniques, a secondary outcome measure. This study focuses on a difference in costs between laparoscopic and small-incision cholecystectomy from a societal perspective with emphasis on internal validity and generalisability
METHODS
A blinded randomized single-centre trial was conducted in a general teaching hospital in The Netherlands. Patients with reasonable to good health diagnosed with symptomatic cholecystolithiasis scheduled for cholecystectomy were included. Patients were randomized between laparoscopic and small-incision cholecystectomy. Total costs were analyzed from a societal perspective.
RESULTS
Operative costs were higher in the laparoscopic group using reusable laparoscopic instruments (difference 203 euro; 95% confidence interval 147 to 259 euro). There were no significant differences in the other direct cost categories (outpatient clinic and admittance related costs), indirect costs, and total costs. More than 60% of costs in employed patients were caused by sick leave.
CONCLUSION
Based on differences in costs, small-incision cholecystectomy seems to be the preferred operative technique over the laparoscopic technique both from a hospital and societal cost perspective. Sick leave associated with convalescence after cholecystectomy in employed patients results in considerable costs to society.
TRIAL REGISTRATION
ISRCTN Register, number ISRCTN67485658.
| 0no significant effect
|
3,608,893 | 23,507,967 |
OBJECTIVE
This study examined the efficacy of a commercially available, portion-controlled diet (PCD) on body weight and HbA1c over 6 months in obese patients with type 2 diabetes.
RESEARCH DESIGN AND METHODS
One-hundred participants with a mean±s.d. age of 55.6±10.6 year, body weight of 102.9±18.4 kg and HbA1c of 7.7±1.3% were randomly assigned to a 9-session group lifestyle intervention that included a PCD or to a 9-session group program of diabetes self-management education (DSME). Participants in the two groups were prescribed the same goals for energy intake (1250-1550 kcal per day) and physical activity (200 min per week).
RESULTS
While both groups produced significant improvements in weight and HbA1c after 6 months of treatment, PCD participants lost 7.3 kg [95% confidence interval (CI): -5.8 to -8.8 kg], compared with 2.2 kg (95% CI: -0.7 to -3.7 kg) in the DSME group (P<0.0001). Significantly more PCD than DSME participants lost 5% of initial weight (54.0% vs 14.0%, P<0.0001) and 10% (26.0% vs 6.0%, P<0.0001). HbA1c declined by 0.7% (95% CI: -0.4 to -1.0%) in the PCD group, compared with 0.4% (95% CI: -0.1 to -0.7%) in DSME (P<0.026). Across both groups, larger weight losses were associated with greater reductions in HbA1c (r=0.52, P<0.0001).
CONCLUSIONS
These findings demonstrate that a commercially available portion-controlled meal plan can induce clinically meaningful improvements in weight and glycemic control in obese individuals with type 2 diabetes. These data have implications for the management of obesity in primary care, as now provided by the Centers for Medicare and Medicaid Services.
| 1significant effect
|
4,535,555 | 25,687,748 |
AIMS
To prospectively compare cardiac magnetic resonance late gadolinium enhancement (LGE) findings created by standard vs. robotically assisted catheter ablation lesions and correlate these with clinical outcomes.
METHODS AND RESULTS
Forty paroxysmal atrial fibrillation patients (mean age 54 ± 13.8 years) undergoing first left atrial ablation were randomized to either robotic-assisted navigation (Hansen Sensei(®) X) or standard navigation. Pre-procedural, acute (24 h post-procedure) and late (beyond 3 months) scans were performed with LGE and T2W imaging sequences and percentage circumferential enhancement around the pulmonary vein (PV) antra were quantified. Baseline pre-procedural enhancements were similar in both groups. On acute imaging, mean % encirclements by LGE and T2W signal were 72% and 80% in the robotic group vs. 60% (P = 0.002) and 76%(P = 0.45) for standard ablation. On late imaging, the T2W signal resolved to baseline in both groups. Late gadolinium enhancement remained the predominant signal with 56% encirclement in the robotic group vs. 45% in the standard group (P = 0.04). At 6 months follow-up, arrhythmia-free patients had an almost similar mean LGE encirclement (robotic 64%, standard 60%, P = 0.45) but in recurrences, LGE was higher in the robotic group (43% vs. 30%, P = 0.001). At mean 3 years follow-up, 1.3 procedures were performed in the robotic group compared with 1.9 (P < 0.001) in the standard to achieve a success rate of 80% vs. 75%.
CONCLUSION
Robotically assisted ablation results in greater LGE around the PV antrum. Effective lesions created through improved catheter stability and contact force during initial treatment may have a role in reducing subsequent re-do procedures.
| 1significant effect
|
5,425,769 | 28,553,314 |
BACKGROUND
Strategies to improve communication in people with dementia are warranted. We examined the effect of the Sonas programme on communication ability in persons with moderate to severe dementia.
METHODS
A 24-week 3-armed (Sonas, reading, and control group) randomized controlled trial including 120 nursing home residents with dementia was conducted; 105 completed the follow-up assessments. The main outcome was change in communication abilities measured by the Holden Communication Scale (HCS).
RESULTS
We found no overall significant effect of the Sonas programme with regard to communication ability as measured by the HCS. However, an effect between the Sonas group and the reading group and between the Sonas group and the control group from T0 to T1 and T2 was found, as well as a significant improvement in communication in the Sonas group. Among people with severe dementia, the Sonas group scored significantly better on the HCS compared to the reading group after 12 weeks, but not after 24 weeks.
CONCLUSION
This study failed to document an overall effect of the Sonas programme on communication; however, the findings indicate that the Sonas programme has a significant effect on communication among those with severe dementia.
| 0no significant effect
|
2,885,597 | 20,556,204 |
BACKGROUND
Most patients with primary biliary cirrhosis (PBC) are treated with ursodeoxycholic acid (UDCA); however, some do not respond fully. PBC is also associated with dyslipidemia, but a link with vascular risk has not been confirmed.
METHODS AND RESULTS
In this study we compared UDCA monotherapy with fenofibrate plus UDCA in PBC patients with incomplete biochemical response to UDCA monotherapy for >/= 8 months. Ten patients (57.2+/-13.3 years old) with PBC and persistent elevations of liver enzymes after treatment with UDCA (600 mg/day) were randomized to continue UDCA (4 patients) or to receive micronized fenofibrate (200 mg/day) plus UDCA (6 patients) for 8 weeks. Significant reductions in total cholesterol, triglycerides and non-high density lipoprotein cholesterol were observed in the combination treatment group. The serum activities of alkaline phosphatase, gamma-glutamyl transpeptidase and alanine aminotranferase also decreased in this group compared with baseline (-32.6%; p=0.012, -44%; p=0.031 and -16.9%; p=0.029, respectively). In contrast, no significant alterations in liver enzymes or lipid profile were observed in patients who continued UDCA monotherapy. The changes in the lipid and enzyme variables differed significantly (p<0.03) between the 2 groups. Fenofibrate was well tolerated.
CONCLUSIONS
The administration of fenofibrate plus UDCA seems to be safe and may improve lipid and liver indices in patients with PBC who do not respond fully to UDCA monotherapy. Whether the improved lipid profile translates into a decreased risk of vascular events remains to be established.
| 1significant effect
|
5,009,836 | 27,625,478 |
BACKGROUND AND AIMS
Patients undergoing elective cesarean delivery (CD) have a high-risk of spinal-induced hypotension (SIH). We hypothesized that a colloid preload would further reduce SIH when compared with a crystalloid preload.
MATERIAL AND METHODS
Eighty-two healthy parturients undergoing elective CD were included in the study. Patients were randomly assigned to two groups (41 patients in each group) to receive either Lactated Ringer's solution (1500 ml) or hydroxyethyl starch (6% in normal saline, 500 ml) 30 min prior to placement of spinal anesthesia. All patients were treated with a phenylephrine infusion (100 mcg/min), titrated during the study.
RESULTS
There was no statistical difference between groups with regards to the incidence of hypotension (10.8% in the colloid group vs. 27.0% in the crystalloid group, P = 0.12). There was also no difference between groups with respect to bradycardia, APGAR scores, and nausea and vomiting. Significantly less phenylephrine (1077.5 ± 514 mcg) was used in the colloid group than the crystalloid group (1477 ± 591 mcg, P = 0.003).
CONCLUSION
The preload with 6% of hydroxyethyl starch before CD might be beneficial for the prevention of SIH.
| 1significant effect
|
2,630,316 | 19,036,149 |
BACKGROUND
International studies report that nurse clinics improve healing rates for the leg ulcer population. However, these studies did not necessarily deliver similar standards of care based on evidence in the treatment venues (home and clinic). A rigorous evaluation of home versus clinic care is required to determine healing rates with equivalent care and establish the acceptability of clinic-delivered care.
METHODS
Health Services RCT was conducted where mobile individuals were allocated to either home or nurse clinic for leg ulcer management. In both arms, care was delivered by specially trained nurses, following an evidence protocol.
PRIMARY OUTCOME
3-month healing rates.
SECONDARY OUTCOMES
durability of healing (recurrence), time free of ulcers, HRQL, satisfaction, resource use. Data were collected at base-line, every 3 months until healing occurred, with 1 year follow-up. Analysis was by intention to treat.
RESULTS
126 participants, 65 randomized to receive care in their homes, 61 to nurse-run clinics. No differences found between groups at baseline on socio-demographic, HRQL or clinical characteristics. mean age 69 years, 68% females, 84% English-speaking, half with previous episode of ulceration, 60% ulcers at inclusion < 5 cm2 for < 6 months. No differences in 3-month healing rates: clinic 58.3% compared to home care at 56.7% (p = 0.5) or in secondary outcomes.
CONCLUSION
Our findings indicate that organization of care not the setting where care is delivered influences healing rates. Key factors are a system that supports delivery of evidence-based recommendations with care being provided by a trained nursing team resulting in equivalent healing rates, HRQL whether care is delivered in the home or in a community nurse-led clinic.
TRIAL REGISTRATION
ClinicalTrials.gov Protocol Registration System: NCT00656383.
| 0no significant effect
|
3,693,661 | 23,825,979 |
BACKGROUND
So far, there have been a few and incoherent results about the effects of physical activities. Fasting in Ramadan has an effect on the level of osmolarity and the concentration of serum electrolytes both in active and inactive females.
OBJECTIVES
The aim of this study was to observe the changes of serum electrolytes and osmolarity levels according to regular exercise during fasting.
PATIENTS AND METHODS
TWENTY TWO HEALTHY FEMALES WHO WERE ELECTED BY CONVENIENCE SAMPLING METHOD WERE DIVIDED INTO TWO GROUPS: 1) fasting + exercise (FE; n = 11) and 2) fasting + non exercise (FNE; n = 15). The FE group participated in aerobic training for four sessions per week during the fasting. All measurements were done once before the first day, on the second week, on the fourth week and two weeks after fasting month and these measures were used to analyze test results.
RESULTS
THE MEAN DIFFERENCES WERE AS FOLLOWS: significant weight loss, BMI, WHR, in two groups at the end of Ramadan (P < 0.05). The mean of weight, BMI, WHR, body fat, protein, mineral and total water showed no difference between groups (P > 0.05). Potassium, creatinine, urea and uric acid had been decreased significantly in both groups (P < 0.05). Variance between groups was significant only in variable urea (P < 0.05). Variations within group had been changed in FBS; sodium, phosphorus and osmolarity levels were not changed significantly.
CONCLUSIONS
According to this result, regular exercise in case of fasting in Ramadan led to some changes in serum osmolarity index, electrolytes and water. Therefore, it is important for female athletes to consider applying a suitable nutritious diet and sufficient water consumption during Ramadan.
| 0no significant effect
|
3,591,547 | 23,493,245 |
BACKGROUND AND OBJECTIVE
With consideration the daily increased development of outpatient surgeries and high rate of these surgeries in elderly patients, rapid and safe recovery of patients is necessary. In this clinical trial study, recovery time and nausea and vomiting after the use of two rapid-onset narcotics, Alfentanil and Remifentanil, in elderly patients were evaluated.
METHODS
In this double-blind prospective clinical trial, 40 elderly patients (age above 65 years) candidate to cataract surgery with general anesthesia were studied. The patients were divided randomly into two groups and for first group, 10 μg/kg of Alfentanil was injected and for second group Remifentanil 0.5 μg/kg was injected intravenously during 30 seconds one minute before induction. Both two groups were under general anesthesia with same method and during the anesthesia, first group took infusion of Alfentanil 1 μg/kg/min and second group took Remifentanil 0.1 μg/kg/min. In the end of surgery, the time intervals between end of anesthesia drug administration and spontaneous respiration, eyes opening with stimulation, verbal response and discharge of recovery room, also the incidence of complications related to narcotic drugs, especially nausea and vomiting, was recorded. The data were analyzed in SPSS software using descriptive and analytical statistics such as T-test and chi square test.
RESULTS
The time of spontaneous respiration in Alfentanil group was 2 minutes and in Remifentanil group was 3.3 minutes, the difference was not statistically significant (P=0.08). The time of eyes opening with stimulation, verbal response, and discharge of recovery room were not significantly different. During recovery, incidence of nausea and vomiting in Remifentanil group (30% of patients) was significantly more than Alfentanil group (5% of patients) (P=0.045).
CONCLUSIONS
Recovery time between Alfentanil and Remifentanil group was not significantly different, but incidence of nausea and vomiting in Remifentanil group was higher than Alfentanil group significantly. It seems that using Alfentanil in the anesthesia for surgical treatment of the elderly people can be preferred.
| 0no significant effect
|
5,080,766 | 27,799,945 |
BACKGROUND
Long-term growth hormone (GH) treatments in short children born small for gestational age (SGA) restore lipid metabolism, but also increase insulin resistance. The aim of this study was to evaluate the influence of long-term GH therapy on lipid and glucose metabolism as well as its dose dependency in short Japanese children born SGA.
METHODS
Eighty Japanese children with a short stature who were born SGA participated in this study; 65 were treated with fixed GH doses of 0.033 (low) or 0.067 (high) mg/kg/day for 260 weeks; 15 were untreated controls in the first year and were randomized to one of the two treatment groups at week 52. Serum cholesterol, glucose and insulin levels were regularly measured. An oral glucose tolerance test (OGTT) was conducted annually.
RESULTS
The mean age at the start of GH therapy was approximately 5.3 years. Serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in the high dose group significantly decreased over time during GH therapy. In both dose groups for TC, and in the high dose group for LDL-C, the higher the baseline values, the greater the decrease after 260 weeks. The rate of the decrease observed after 260 weeks in patients with high LDL-C levels was greater in the high dose group. Based on the results of OGTT, no patient was classified as being diabetic; however, annual increases were observed in post-OGTT insulin levels. After 260 weeks, the homeostasis model assessment as an index of insulin resistance (HOMA-IR) increased, suggesting that insulin resistance developed over time with the GH treatment, while 36.6 % of the subjects entered puberty.
CONCLUSIONS
Long-term continuous GH treatment for children born SGA may have a potentially beneficial effect on several parameters in lipid metabolism and does not adversely affect glucose metabolism.
TRIAL REGISTRATION
GHLIQUID-1516, GHLIQUID-1517, Japan Pharmaceutical Information Center Clinical trial registration: JapicCTI-050132. Registered 13 September 2005. Retrospectively registered. JapicCTI-050137. Registered 13 September 2005. Retrospectively registered. ClinicalTrials.gov trial registration: NCT00184717. Registered 13 September 2005. Retrospectively registered.
| 1significant effect
|
3,692,346 | 23,818,758 |
BACKGROUND
Uncontrolled asthma is characterized by considerable variability. Well controlled asthma is associated with less unplanned use of health care resources and fewer acute exacerbations. In this study, we attempted to increase inhaled corticosteroid (ICS) doses initially in suboptimally controlled asthmatics, hypothesizing that early achievement of asthma control using this strategy would be associated positively with a higher level of stability.
METHODS
This was a randomized, open-label, prospective study including patients with uncontrolled asthma who were randomized to receive higher-dose (HD) ICS in combination with a long-acting beta-agonist (LABA) for one month and then shifted to doses suggested in the practice guidelines (GD) or to receive GD therapy alone. Lung function, ie, forced expiratory volume in one second (FEV(1)), peak expiratory flow, Asthma Control Test scores, and frequency of acute exacerbations, was followed up for one year.
RESULTS
Seventy-six patients were treated with the HD strategy and 80 with the GD strategy. The increase in FEV(1) from baseline was greater in the HD group than in the GD group, especially during the first month of treatment (304 ± 49 mL versus 148 ± 39 mL, respectively, P = 0.01). Numbers of patients with completely or well controlled asthma were higher in the HD group than in the GD group (92.1% versus 81.1%, respectively, P = 0.03). Further, there was a significant difference between the groups with regard to frequency of acute exacerbations (9.2% in the HD group versus 21.3% in the GD group, P = 0.02); this effect was more pronounced for patients in the HD group with partially controlled or uncontrolled asthma.
CONCLUSION
Patients receiving HD therapy achieved asthma control more rapidly and maintained greater stability than those receiving GD therapy. This represents a novel strategy for gaining disease control in patients with uncontrolled asthma.
| 1significant effect
|
2,974,661 | 20,958,972 |
BACKGROUND
Breathlessness is common and distressing in advanced disease. This phase II study aimed to determine the use and acceptance of a hand-held fan (HHF) to relieve breathlessness, to test the effectiveness of the HHF and to evaluate the recruitment into the study.
METHODS
RCT embedded within a longitudinal study testing a HHF over time compared to a wristband. Patients were included in the longitudinal study when suffering from breathlessness due to advanced cancer or COPD III/IV and could opt in the RCT. Primary outcome was use of the HHF and the wristband after two months. Secondary outcomes were recruitment into the trial and change of breathlessness severity after two months, measured on the modified Borg scale. Baseline data were collected in a personal interview and follow-up data by monthly postal questionnaires.
RESULTS
109 patients were recruited in the longitudinal study of which 70 patients (64%) participated in the RCT. Non-participants had statistically significant less breathlessness (Borg mean 2.6 (SD 1.48) versus 3.7 (SD 1.83); p = 0.003) and a better functional status (Karnofsky status mean 61.9 (SD 11.2) versus 66.7 (SD 11.0); p = 0.03). Attrition due to drop out or death was high in both groups. After two months, about half of the patients used the HHF but only 20% the wristband without a statistical difference (Fisher's exact test p = 0.2). 9/16 patients judged the HHF as helpful after two months and 4/5 patients the wristband. There was no difference in mean breathlessness change scores between the HHF (Borg change score: mean 0.6 (SD 2.10)) and the wristband (mean 0.8 (SD 2.67)) after two months (p = 0.90).
CONCLUSIONS
Symptom burden and low functional status did not restrain patients from participation in the study. Finding a control for a visible intervention is challenging and needs careful consideration to what is acceptable to patients. The preliminary evidence of effectiveness of the HHF could not be proved. Patients often stopped using the HHF but a small group seemed to benefit which was not necessarily related to a relief in breathlessness. Therefore, more work is necessary on selecting and identifying those who might benefit from the HHF.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01123902.
| 0no significant effect
|
3,774,725 | 24,066,145 |
OBJECTIVES
The objective of this study was to evaluate a patient navigation (PN) program that attempts to reduce the time between a breast cancer screening abnormality and definitive diagnosis among medically underserved populations of Tampa Bay, Florida.
METHODS
The Moffitt Patient Navigation Research Program conducted a cluster randomized design with 10 primary care clinics. Patients were navigated from time of a breast screening abnormality to diagnostic resolution. This paper examined the length of time between breast abnormality and definitive diagnosis, using a shared frailty Cox proportional hazard model to assess PN program effect.
RESULTS
1,039 patients were eligible for the study because of an abnormal breast cancer screening/clinical abnormality (494 navigated; 545 control). Analysis of PN effect by two time periods of resolution (0-3 months and > 3 months) showed a lagged effect of PN. For patients resolving in the first three months, the adjusted Hazard Ratio (aHR) was 0.85 (95% Confidence Interval [CI]: 0.64-1.13) suggesting that PN had no effect on resolution time during this period. Beyond three months, however, navigated patients resolved more quickly to diagnostic resolution compared with the control group (aHR 2.8, 95%CI: 1.30-6.13). The predicted aHR at 3 months was 1.2, which was not statistically significant, while PN had a significant positive effect beyond 4.7 months.
CONCLUSIONS
PN programs may increase the timeliness of diagnostic resolution for patients with a breast cancer-related abnormality. PN did not speed diagnostic resolution during the initial three months of follow up but started to reduce time to diagnostic resolution after three months and showed a significant effect after 4.7 months.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00375024.
| 0no significant effect
|
1,175,929 | 15,774,049 |
INTRODUCTION
Septic shock is associated with increased microvascular permeability. As a model for study of the pathophysiology of sepsis, endotoxin administration to humans has facilitated research into inflammation, coagulation and cardiovascular effects. The present study was undertaken to determine whether endotoxin administration to human volunteers can be used as a model to study the sepsis-associated increase in microvascular permeability.
METHODS
In an open intervention study conducted in a university medical centre, 16 healthy volunteers were evaluated in the research unit of the intensive care unit. Eight were administered endotoxin intravenously (2 ng/kg Escherichia coli O113) and eight served as control individuals. Microvascular permeability was assessed before and 5 hours after the administration of endotoxin (n = 8) or placebo (n = 8) by three different methods: transcapillary escape rate of I(125)-albumin; venous occlusion strain-gauge plethysmography to determine the filtration capacity; and bioelectrical impedance analysis to determine the extracellular and total body water.
RESULTS
Administration of endotoxin resulted in the expected increases in proinflammatory cytokines, temperature, flu-like symptoms and cardiovascular changes. All changes were significantly different from those in the control group. In the endotoxin group all microvascular permeability parameters remained unchanged from baseline: transcapillary escape rate of I(125)-albumin changed from 7.2 +/- 0.6 to 7.7 +/- 0.9%/hour; filtration capacity changed from 5.0 +/- 0.3 to 4.2 +/- 0.4 ml/min per 100 ml mmHg x 10(-3); and extracellular/total body water changed from 0.42 +/- 0.01 to 0.40 +/- 0.01 l/l (all differences not significant).
CONCLUSION
Although experimental human endotoxaemia is frequently used as a model to study sepsis-associated pathophysiology, an endotoxin-induced increase in microvascular permeability in vivo could not be detected using three different methods. Endotoxin administration to human volunteers is not suitable as a model in which to study changes in microvascular permeability.
| 0no significant effect
|
3,339,723 | 22,557,741 |
OBJECTIVE
Headache is not an uncommon complication of spinal anesthesia. The efficacy of intravenous (IV) hydrocortisone in treating the patients with postdural puncture headache was observed in this study.
MATERIALS AND METHODS
Sixty patients with headache following spinal anesthesia were randomly allocated into two groups. Thirty patients received only conventional therapy (recumbent positioning, IV or oral hydration, analgesics with caffeine, stool softeners, and soft diet) plus 2 ml of normal saline IV (placebo) 8 hourly for 48 h. Thirty other patients received conventional therapy plus hydrocortisone IV (100 mg in 2 ml 8 hourly for 48 h). Headache intensity was measured using visual analogue scale.
RESULTS
No significant difference was observed in baseline headache intensity between the two groups (P = 0.6642) before beginning of treatment. After 6 h, the mean headache intensity in patients treated conventionally was 6.02 ± 2.46, while it was 2.06 ± 1.98 in other patients who received additional hydrocortisone IV (P < 0.0001). After 24 h, headache intensity was 3.77 ± 1.85 in conventionally treated group versus 0.94 ± 2.67 in hydrocortisone group (P < 0.0001), while it was 1.95 ± 1.12 in conventionally treated group versus 0.69 ± 1.64 in hydrocortisone group (P = 0.001) after 48 h.
CONCLUSIONS
Very short-term use of IV hydrocortisone was found effective in reducing headache following spinal anesthesia. However, its clear mechanism of action is yet to be determined. Large-scale studies are recommended to consider the steroid therapy as a standard treatment for postdural puncture headache.
| 1significant effect
|
3,537,701 | 23,031,570 |
BACKGROUND
Non-specific chronic low back pain (NSCLBP) is one of the most common musculoskeletal disorders around the world including Iran. One of the most widely used modalities in the field of physiotherapy is therapeutic ultrasound (US). Despite its common use, there is still inconclusive evidence to support its effectiveness in patients with NSCLBP. The objective of this study was to evaluate the effect of continuous US compared with placebo US additional to exercise therapy for patients with NSCLBP.
METHODS
In this single blind placebo controlled study, 50 patients with NSCLBP were randomized into two treatment groups: 1) continuous US (1 MHz &1.5 W/cm2) plus exercise 2) placebo US plus exercise. Patients received treatments for 4 weeks, 10 treatment sessions, 3 times per week, every other day. Treatment effects were assessed in terms of primary outcome measures: 1) functional disability, measured by Functional Rating Index, and 2) global pain, measured by a visual analog scale. Secondary outcome measures were lumbar flexion and extension range of motion (ROM), endurance time and rate of decline in median frequency of electromyography spectrum during a Biering Sorensen test. All outcome variables were measured before, after treatment, and after one-month follow-up. An intention to treat analysis was performed. Main effects of Time and Group as well as their interaction effect on outcome measures were investigated using repeated measure ANOVA.
RESULTS
Analysis showed that both groups had improved regarding function (FRI) and global pain (VAS) (P < .001). Lumbar ROM as well as holding time during the Sorensen test and median frequency slope of all measured paravertebral muscles did not change significantly in either group (P > .05). Improvement in function and lumbar ROM as well as endurance time were significantly greater in the group receiving continuous US (P < .05).
CONCLUSIONS
The study showed that adding continuous US to a semi supervised exercise program significantly improved function, lumbar ROM and endurance time. Further studies including a third group of only exercise and no US can establish the possible effects of placebo US.
TRIAL REGISTRATION
NTR2251.
| 1significant effect
|
3,262,135 | 21,630,047 |
PURPOSE
In this double-blinded, randomised clinical trial, the aim was to compare the analgesic effects of low doses of intra-articular Bupivacaine and Ropivacaine against placebo after knee arthroscopy performed under general anaesthesia.
METHODS
A total of 282 patients were randomised to 10 cc NaCl 0.9%, 10 cc Bupivacaine 0.5% or 10 cc Ropivacaine 0.75%. Patients received the assigned therapy by intra-articular injection after closure of the portal. Pain and satisfaction were measured at one, 4 h and 5-7 days after arthroscopy with Numerical Rating Scale (NRS) -scores. NSAID consumption was also recorded.
RESULTS
One-h NRS-scores at rest were higher in the NaCl group compared with the Bupivacaine group (P < 0.01), 1 h NRS-scores in flexion were higher in the NaCl group compared with the Bupivacaine (P < 0.01) and Ropivacaine (P < 0.01) groups. NRS-satisfaction at 4 h was higher for the Bupivacaine group compared with the NaCl group (P = 0.01). Differences in NRS-scores were significant but low in magnitude. NSAID consumption was lower in the Bupivacaine group compared with the NaCl group (P < 0.01).
CONCLUSIONS
The results of this randomised clinical trial demonstrate improved analgesia after administration of low doses of intra-articular Bupivacaine and Ropivacaine after arthroscopy of the knee. Considering reports of Bupivacaine and Ropivacaine being chondrotoxic agents and the relatively small improvement on patient comfort found in this trial, it is advised to use systemic anaesthetic instead of intra-articular Bupivacaine or Ropivacaine for pain relief after knee arthroscopy.
| 1significant effect
|
4,269,914 | 25,525,417 |
BACKGROUND
Previous animal study has shown that supplementation with silk amino acid hydrolysate (SAA) increases stamina in mice. The presented study was the first formal evaluation of the influence of SAA supplementation on parameters defining physiological fitness level in humans.
METHODS
It was a randomized controlled trial with a parallel-group design on elite male fin-swimmers. The experimental group was supplemented with 500 mg of SAA per kg of body mass, dissolved in 250 ml of a Carborade Drink®; the control group with Carborade Drink® alone; 3 times a day, 30 minutes prior to the training session.
RESULTS
Changes discerned in the experimental group were more pronounced than those observed in the control group. For example, the change in the serum lactic acid concentration observed in the experimental group was sevenfold less than in the control group [21.8 vs. -3.7 L% for the control and experimental groups, respectively]. An analysis of a lactate profile as a function of a maximal swimming velocity exposed a statistically significant positive shift in the swimming velocity of 0.05 m/s, at the lactate concentration of 4 mmol/L in the experimental group. There was also a positive, although statistically insignificant, increase of 2.6 L% in serum testosterone levels in the experimental group.
CONCLUSIONS
This study showed that a 12-day SAA supplementation combined with an extensive and rigorous training schedule was sufficient to increase an aerobic stamina. However, this phenomenon was associated with an augmented level of muscular damage (an increased level of creatine phosphokinase in the experimental group).
| 1significant effect
|
4,759,860 | 26,900,386 |
BACKGROUND
Many human studies report that nitric oxide (NO) improves sport performance. This is because NO is a potential modulator of blood flow, muscle energy metabolism, and mitochondrial respiration during exercise. L-Citrulline is an amino acid present in the body and is a potent endogenous precursor of L-arginine, which is a substrate for NO synthase. Here, we investigated the effect of oral L-citrulline supplementation on cycling time trial performance in humans.
METHODS
A double-blind randomized placebo-controlled 2-way crossover study was employed. Twenty-two trained males consumed 2.4 g/day of L-citrulline or placebo orally for 7 days. On Day 8 they took 2.4 g of L-citrulline or placebo 1 h before a 4-km cycling time trial. Time taken to complete the 4 km cycle, along with power output/VO2 ratio (PO/VO2), plasma nitrite and nitrate (NOx) and amino acid levels, and visual analog scale (VAS) scores, was evaluated.
RESULTS
L-Citrulline supplementation significantly increased plasma L-arginine levels and reduced completion time by 1.5 % (p < 0.05) compared with placebo. Moreover, L-citrulline significantly improved subjective feelings of muscle fatigue and concentration immediately after exercise.
CONCLUSIONS
Oral L-citrulline supplementation reduced the time take to complete a cycle ergometer exercise trial.
TRIAL REGISTRATION
Current Controlled Trials UMIN000014278.
| 1significant effect
|
4,227,298 | 24,993,581 |
BACKGROUND
External pilot or feasibility studies can be used to estimate key unknown parameters to inform the design of the definitive randomised controlled trial (RCT). However, there is little consensus on how large pilot studies need to be, and some suggest inflating estimates to adjust for the lack of precision when planning the definitive RCT.
METHODS
We use a simulation approach to illustrate the sampling distribution of the standard deviation for continuous outcomes and the event rate for binary outcomes. We present the impact of increasing the pilot sample size on the precision and bias of these estimates, and predicted power under three realistic scenarios. We also illustrate the consequences of using a confidence interval argument to inflate estimates so the required power is achieved with a pre-specified level of confidence. We limit our attention to external pilot and feasibility studies prior to a two-parallel-balanced-group superiority RCT.
RESULTS
For normally distributed outcomes, the relative gain in precision of the pooled standard deviation (SDp) is less than 10% (for each five subjects added per group) once the total sample size is 70. For true proportions between 0.1 and 0.5, we find the gain in precision for each five subjects added to the pilot sample is less than 5% once the sample size is 60. Adjusting the required sample sizes for the imprecision in the pilot study estimates can result in excessively large definitive RCTs and also requires a pilot sample size of 60 to 90 for the true effect sizes considered here.
CONCLUSIONS
We recommend that an external pilot study has at least 70 measured subjects (35 per group) when estimating the SDp for a continuous outcome. If the event rate in an intervention group needs to be estimated by the pilot then a total of 60 to 100 subjects is required. Hence if the primary outcome is binary a total of at least 120 subjects (60 in each group) may be required in the pilot trial. It is very much more efficient to use a larger pilot study, than to guard against the lack of precision by using inflated estimates.
| 1significant effect
|
5,106,769 | 27,857,944 |
BACKGROUND
The so-called macular carotenoids (MC) lutein (L), zeaxanthin (Z), and meso-zeaxanthin (MZ) comprise the diet-derived macular pigment (MP). The purpose of this study was to determine effects of MC supplementation on the optical density of MP (MPOD), repeated-exposure photostress recovery (PSR), and disability glare (DG) thresholds.
METHODS
This was a double-blind, placebo-controlled trial. Fifty-nine young (mean age = 21.7), healthy volunteers participated in this study. Subjects supplemented their daily diet with either 10 mg L + 2 mg total Z (1 mg Z + 1 mg MZ; n = 24), 20 mg L + 4 mg total Z (2 mg Z + 2 mg MZ; n = 25), or placebo ( n = 10) for 12 months. The primary outcome was a composite measure of visual performance in glare, defined by change in DG and PSR. Secondary outcomes included MPOD and visual fatigue. The primary endpoint for outcomes was 12 months. MPOD was assessed with customized heterochromatic flicker photometry. PSR times for an 8 cycle /degree, 15 % contrast Gabor patch target were determined after each of five successive exposures to intense LED lights. DG threshold was defined as the intensity of a ring of lights through which subjects were able to maintain visibility of the aforementioned target. Measures of all parameters were conducted at baseline, 6 months, and 12 months. Repeated-measures ANOVA, and Pearson product-moment correlations were used to determine statistically significant correlations, and changes within and between groups.
RESULTS
MPOD for subjects in both supplementation groups increased significantly versus placebo at both 6- and 12-month visits ( p < 0.001 for all). Additionally, PSR times and DG thresholds improved significantly from baseline compared to placebo at 6- and 12-month visits ( p < 0.001 for all). At baseline, MPOD was significantly related to both DG thresholds ( r = 0.444; p = 0.0021) and PSR times ( r = -0.56; p < 0.001). As a function of MPOD, the repeated-exposure PSR curves became more asymptotic, as opposed to linear. The change in subjects' DG thresholds were significantly related to changes in PSR times across the study period ( r = -0.534; p < 0.001).
CONCLUSIONS
Increases in MPOD lead to significant improvements in PSR times and DG thresholds. The asymptotic shape of the repeated-exposure PSR curves suggests that increases in MPOD produce more consistent steady-state visual performance in bright light conditions. The mechanism for this effect may involve both the optical filtering and biochemical (antioxidant) properties of MP.
TRIAL REGISTRATION
ISRCTN trial registration number: ISRCTN54990825. Data reported in this manuscript represent secondary outcome measures from the registered trial.
| 1significant effect
|
5,741,844 | 29,302,283 |
BACKGROUND
The aim of the present study was to compare the amount of the smear layer remaining in prepared root canals with different protocols of Bio RaCe files and XP-endo Finisher file (XPF) in association with 17% EDTA and sodium hypochlorite solution.
MATERIAL AND METHODS
A total of 68 extracted single-rooted teeth were randomly divided into 4 experimental groups (n=14) and two control groups (n=6). The root canals were prepared with Bio RaCe files (FKG Dentaire, Switzerland) using the crown-down technique based on manufacturer's instructions and irrigated according to the following irrigation techniques: Group 1: XPF with 2 mL of 2.5% NaOCl for 1 minute. Group 2:, XPF with 1 mL of 17% EDTA for one minute. Group 3: XPF was used for 1 minute in association with normal saline solution. Group 4: XP-endo Finisher file for 30 seconds in association with 2.5% NaOCl and 17% EDTA for 30 seconds. The negative control group: NaOCl (2.5%) was used during root canal preparation, followed by irrigation with 17% EDTA at the end of root canal preparation. The positive control group: Normal saline solution was used for irrigation during root canal preparation. In all the groups, during preparation of the root canals with Bio RaCe file, 20 mL of 2.5% NaOCl was used for root canal irrigation and at the end of the procedural steps 20 mL of normal saline solution was used as a final irrigant. The samples were analyzed under SEM at ×1000‒2000 magnification and evaluated using Torabinejad scoring system. Data were analyzed with non-parametric Kruskal-Wallis test and post hoc Mann-Whitney U test, using SPSS. Statistical significant was defined at P <0.05.
RESULTS
The results of the study showed the least amount of the smear layer at coronal, middle and apical thirds of the root canals in groups 2, which was not significantly different from the negative control group ( P <0.5).
CONCLUSIONS
Under the limitations of the present study, use of a combination of NaOCl and EDTA in association with XPF exhibited the best efficacy for the removal of the smear layer. Key words: Smear layer, XP-endo Finisher file, EDTA, Sodium hypochlorite.
| 0no significant effect
|
5,309,308 | 28,050,795 |
PURPOSE
Bladder cancer (BC) is one of the most common cancers worldwide. BC diagnosis and surveillance is based on cystoscopy (CS). CS impact on patient's depression, anxiety, and sexual satisfaction (SS) is not sufficiently studied. There are no data on patient's comfort with flexible or rigid CS.
METHODS
We prospectively evaluated pain perception (PP), depression, anxiety, and SS of 100 male patients who previously underwent at least one rigid CS in our department as surveillance after TURB procedure due to non-muscle-invasive BC and were scheduled for the next CS examination. The patients were randomized for flexible or rigid CS. Before CS, patients described their recalled rigid CS-related pain by NRS and fulfilled HADS and SS questionnaires. After CS, PP was re-evaluated immediately and HADS and SS within 7-10 days following the CS.
RESULTS
The baseline scores include 5.2 ± 2.6 points for rigid CS recalled pain, 7.2 ± 3.0 points for HADS anxiety, 5.8 ± 3.5 for depression, and 27.8 ± 5.1 for SS. The flexible CS-related pain was approximately three times lower than the recalled pain level and also than the current rigid CS related (p < 0.001). Mean SS score was two points lowered after rigid CS (p < 0.001). One point decrease in anxiety level was observed after flexible CS (p < 0.001). Multivariate analysis supported the hypothesis of patients benefiting from flexible CS in terms of pain perception, anxiety symptoms, and SS.
CONCLUSIONS
Our study demonstrates the superiority of flexible CS in terms of pain alleviation, and shifts in SS and anxiety levels.
| 1significant effect
|
4,461,930 | 26,064,192 |
INTRODUCTION
The negative efficacy study examining the γ-secretase inhibitor semagacestat in mild to moderate Alzheimer's disease (AD) included a number of biomarkers of the disease as well as safety outcomes. We analyzed these data to explore relationships between drug exposure and pharmacodynamic effects and to examine the correlations among outcome measures.
METHODS
The study was a multicenter, randomized, placebo-controlled trial of two dose regimens of semagacestat and a placebo administered for 18 months to individuals with mild to moderate AD. Changes in measures of central and peripheral drug activity were compared between the three treatment groups using one-way analysis of variance. The relationship between changes in each of the outcome measures and measures of drug exposure and peripheral pharmacodynamic effect were assessed using Spearman's correlation coefficient.
RESULTS
Assignment to the active treatment arms was associated with reduction in plasma amyloid-β (Aβ) peptides, increase in ventricular volume, decrease in cerebrospinal fluid phosphorylated tau (p-tau) and several other laboratory measures and adverse event categories. Within the active arms, exposure to drug, as indicated by area under the concentration curve (AUC) of blood concentration, was associated with reduction in plasma Aβ peptides and a subset of laboratory changes and adverse event rates. Ventricular volume increase, right hippocampal volume loss and gastrointestinal symptoms were related to change in plasma Aβ peptide but not AUC, supporting a link to inhibition of γ-secretase cleavage of the amyloid precursor protein. Cognitive decline correlated with ventricular expansion and reduction in p-tau.
CONCLUSION
These findings may inform future studies of drugs targeting secretases involved in Aβ generation.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00594568. Registered 11 January 2008.
| 1significant effect
|
4,148,632 | 25,177,521 |
PURPOSE
THE PURPOSE OF THIS STUDY WAS TO ASSESS AND COMPARE THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF GUIDED TISSUE REGENERATION THERAPY FOR HUMAN PERIODONTAL INTRABONY DEFECTS USING TWO DIFFERENT COLLAGEN MEMBRANES: a porous nonchemical cross-linking collagen membrane (NC) and a bilayer collagen membrane (BC).
METHODS
Thirty subjects were randomly assigned and divided into the following 3 groups: a test group (NC+BM), in which a NC was used with xenograft bone mineral (BM), a positive control group (BC+BM), in which a BC was used with xenograft BM, and a negative control group (BM), in which only xenograft BM was used. The following clinical measurements were taken at baseline and 3 months after surgery: plaque index, gingival index, probing pocket depth, gingival recession, and clinical attachment level. Radiographic analysis was performed at baseline, 1 week and 3 months after surgery.
RESULTS
Membrane exposure was not observed in any cases. Significant probing depth reduction, attachment-level gain and bone fill were observed for both test and control groups compared to baseline at 3 months after surgery (P<0.05). However, there were no statistically significant differences in clinical improvement and radiographic bone fill between treatment protocols (P>0.05).
CONCLUSIONS
Within the limitations of this study, the results suggest that both NC and BC were comparable in terms of clinical and radiographic outcomes for the treatment of periodontal intrabony defects in human subjects.
| 0no significant effect
|
4,545,550 | 26,286,137 |
BACKGROUND
Yoga can reduce blood pressure and has also been suggested to reduce inflammatory biomarkers and metabolic risk factors for cardiovascular diseases (CVDs). We aimed to assess the benefit of two yoga interventions on inflammatory biomarkers and metabolic risk factors in a high risk population in primary care.
METHODS
Adult patients from a health care center in Sweden, with diagnosed hypertension, were invited to undergo a baseline check at the health care center. Baseline check included standardized blood pressure measurement, BMI and weight circumference measurements, blood sampling (hs-CRP, IL-6, FP-glucose, HbA1c, cholesterol, TG, LDL and HDL) and a questionnaire on self-rated quality of life (WHOQOL-BREF). There were three groups: 1) yoga class with yoga instructor; 2) yoga at home; and 3) a control group. In total, 83 patients were included and matched at the group level for systolic blood pressure. A majority of the patients (92 %) were on antihypertensive medication, which they were requested not to change during the study. After 12 weeks of intervention, the assessments were performed again.
RESULTS
We recorded no evidence that yoga altered inflammatory biomarkers or metabolic risk factors in our study population. A total of 49 participants (59 %) met the criteria for metabolic syndrome.
CONCLUSION
The yoga interventions performed in our study did not affect inflammatory biomarkers or metabolic risk factors associated with CVD in the study population of primary care patients with hypertension. Further randomized trials are needed to elucidate the effects of yoga on CVD risk factors in this particular group.
TRAIL REGISTRATION
NCT01302535 , February 22, 2011.
| 0no significant effect
|
3,785,902 | 24,083,001 |
BACKGROUND
Hemodynamic changes and respiratory tract complications are often followed by tracheal extubation. These events may be dangerous in neurosurgical patients and those with cardiovascular disease or at an old age.
OBJECTIVES
The aim of this study is to investigate the attenuation of cardiovascular responses and upper airway events resulting from tracheal extubation by low dose propofol.
MATERIALS AND METHODS
80 patients with ASA physical status I, undergoing an elective surgery in a double blind manner received 0.5mg/kg propofol or normal saline 2 minutes before extubation. Heart rate and blood pressure and quality of tracheal extubation were recorded.
RESULTS
Heart rate and blood pressure in patients receiving propofol were less than the control group (P < 0.05) at the time of injection of propofol, but there were no differences between the two groups at the time of extubation.
CONCLUSIONS
We concluded that propofol can reduce SBP, DBP, MAP, HR & cough production at the time of injection but there were no significant changes in these parameters after extubation.
| 0no significant effect
|
5,091,022 | 27,818,976 |
OBJECTIVES
To evaluate bleeding and the estimated blood loss in patients who underwent total knee replacement (TKR) with different closed suction drains (3.2-mm and 4.8-mm gauge).
METHODS
This was a randomized controlled trial with 22 patients who underwent TKR and were divided into two groups: Group I, with 11 patients in whom the 3.2-mm suction drain was used, and Group II, with 11 patients in whom the 4.8-mm suction drain was used. The hematocrit was measured after 24, 48 and 72 h after surgery in order to calculate the estimated blood loss. The drained volume was measured 3, 6, 12, 24, and 48 h after TKR, and thereafter both groups were compared.
RESULTS
Regarding the hematocrit, there were no differences between groups in measured periods (24, 48, and 72 h after surgery). The total bleeding measured at the suction drains within 48 h was higher in Group II, with a statistically significant difference ( p = 0.005); in the first 24 h, there was major bleeding in Group II (mean 893 mL), with a significant difference ( p = 0.004). Between 24 and 48 h, there was no statistically significant difference in both groups ( p = 0.710). The total estimated bleeding was higher in Group I, with mean of 463 mL, versus 409 mL in Group II, with no statistical significance ( p = 0.394).
CONCLUSIONS
Bleeding was higher in the group that used the 4.8 mm gauge suction drain, with no differences in hematocrit and estimated blood loss.
| 0no significant effect
|
4,009,088 | 24,868,432 |
PURPOSE
L-glutamine is the most abundant amino acid found in human muscle and plays an important role in protein synthesis and can reduce the levels of inflammation biomarkers and creatine kinase (CK) after training sessions. Delayed onset muscle soreness (DOMS) develops after intense exercise and is associated with an inflammatory response. The purpose of this study was to investigate the effect of glutamine supplementation on surface electromyography activity of the vastus medialis muscle (VMM) and rectus femoris muscle (RFM) and levels of creatine kinase after an eccentric contraction.
METHODS
SEVENTEEN HEALTHY MEN (AGE: 22.35±2.27yr; body mass: 69.91± 9.78kg; height: 177.08±4.32cm) were randomly assigned to experimental (n=9) and control groups (n=8) in a double-blind manner. In both groups, subjects were given L-glutamine supplementation (0.1g.kg(-1)) or placebo three times a week for 4 weeks. Median frequency (MDF) and mean power frequency (MPF) for VMM and RFM muscles and also CK measurements were performed before, 24h and 48 h after a resistance training session. The resistance training included 6 sets of eccentric leg extensions to exhaustion with 75% of 1RM.
RESULTS
There was no significant difference between groups for MDF or MPF in VMM and RFM. The difference of CK level between the groups was also not significant.
CONCLUSION
The results of this study indicate that glutamine supplementation has no positive effect on muscle injury markers after a resistance training session.
| 0no significant effect
|
3,781,502 | 23,698,396 |
OBJECTIVE
To compare efficacy and safety of lixisenatide once daily versus exenatide twice daily in type 2 diabetes inadequately controlled with metformin.
RESEARCH DESIGN AND METHODS
Adults with diabetes inadequately controlled (HbA1c 7-10%) with metformin were randomized to lixisenatide 20 μg once daily (n=318) or exenatide 10 μg twice daily (n=316) in a 24-week (main period), open-label, parallel-group, multicenter study. The primary objective was a noninferiority assessment of lixisenatide versus exenatide in HbA1c change from baseline to week 24.
RESULTS
Lixisenatide once daily demonstrated noninferiority in HbA1c reduction versus exenatide twice daily. The least squares mean change was -0.79% (mean decrease 7.97 to 7.17%) for lixisenatide versus -0.96% (mean decrease 7.96 to 7.01%) for exenatide, and treatment difference was 0.17% (95% CI, 0.033-0.297), meeting a predefined noninferiority upper CI margin of 0.4%. Responder rate (HbA1c<7.0%) and improvements in fasting plasma glucose were comparable. Both agents induced weight loss (from 94.5 to 91.7 kg and from 96.7 to 92.9 kg with lixisenatide and exenatide, respectively). Incidence of adverse events (AEs) was similar for lixisenatide and exenatide, as was incidence of serious AEs (2.8 and 2.2%, respectively). Discontinuations attributable to AEs occurred in 33 lixisenatide (10.4%) and 41 exenatide (13.0%) patients. In the lixisenatide group, fewer participants experienced symptomatic hypoglycemia (2.5 vs. 7.9%; P<0.05), with fewer gastrointestinal events (especially nausea; 24.5 vs. 35.1%; P<0.05).
CONCLUSIONS
Add-on lixisenatide once daily in type 2 diabetes inadequately controlled with metformin demonstrated noninferior improvements in HbA1c, with slightly lower mean weight loss, lower incidence of hypoglycemia, and better gastrointestinal tolerability compared with exenatide twice daily.
| 1significant effect
|
4,311,411 | 25,519,680 |
BACKGROUND
Charcot-Marie-Tooth type 1A disease (CMT1A) is a rare orphan inherited neuropathy caused by an autosomal dominant duplication of a gene encoding for the structural myelin protein PMP22, which induces abnormal Schwann cell differentiation and dysmyelination, eventually leading to axonal suffering then loss and muscle wasting. We favour the idea that diseases can be more efficiently treated when targeting multiple disease-relevant pathways. In CMT1A patients, we therefore tested the potential of PXT3003, a low-dose combination of three already approved compounds (baclofen, naltrexone and sorbitol). Our study conceptually builds on preclinical experiments highlighting a pleiotropic mechanism of action that includes downregulation of PMP22. The primary objective was to assess safety and tolerability of PXT3003. The secondary objective aimed at an exploratory analysis of efficacy of PXT3003 in CMT1A, to be used for designing next clinical development stages (Phase 2b/3).
METHODS
80 adult patients with mild-to-moderate CMT1A received in double-blind for 1 year Placebo or one of the three increasing doses of PXT3003 tested, in four equal groups. Safety and tolerability were assessed with the incidence of related adverse events. Efficacy was assessed using the Charcot-Marie-Tooth Neuropathy Score (CMTNS) and the Overall Neuropathy Limitations Scale (ONLS) as main endpoints, as well as various clinical and electrophysiological outcomes.
RESULTS
This trial confirmed the safety and tolerability of PXT3003. The highest dose (HD) showed consistent evidence of improvement beyond stabilization. CMTNS and ONLS, with a significant improvement of respectively of 8% (0.4% - 16.2%) and 12.1% (2% - 23.2%) in the HD group versus the pool of all other groups, appear to be the most sensitive clinical endpoints to treatment despite their quasi-stability over one year under Placebo. Patients who did not deteriorate over one year were significantly more frequent in the HD group.
CONCLUSIONS
These results confirm that PXT3003 deserves further investigation in adults and could greatly benefit CMT1A-diagnosed children, usually less affected than adults.
TRIAL REGISTRATION
EudraCT Number: 2010-023097-40. ClinicalTrials.gov Identifier: NCT01401257. The Committee for Orphan Medicinal Products issued in February 2014 a positive opinion on the application for orphan designation for PXT3003 (EMA/OD/193/13).
| 1significant effect
|
5,856,907 | 29,607,334 |
INTRODUCTION
Student-generated questions can be a very helpful tool in medical education. The use of this activity can allow the students to feel more involved in the subjects covered and may improve their knowledge and learning. The aim of this study was to identify the effect of question-writing activity as a stimulus factor on learning in midwifery students and determine their perception about this activity.
METHODS
This quasi-experimental study with two groups of pre- and post-tests was conducted on two groups of midwifery students who had taken the immunology course. Two classes of midwifery students (N=62) participated and were randomly assigned to two different groups. One class was selected as the experimental group (n=32) and the other class was considered as the control group (n=30). The experimental group's students were asked to write questions covering different topics of the syllabus components taught during 15 weeks from February 2016 to May 2016. They were asked to write, answer and explain their multiple-choice questions (MCQs). The students' performance in immunology course was compared between the two groups at the end of the semester. After their final exam, we asked them to fill in a questionnaire on their views about this activity. The data were analyzed by independent t- test using SPSS software, version 18.
RESULTS
The differences between pre- and post-test mean scores of the experimental and control groups were 24.53±5.74 and 20.63±5.58, respectively. The results of independent t-test showed that these differences in the two groups were significant (p=0.009). Nevertheless, most of the students stated that question-writing activity as a learning tool is an unfamiliar exercise and unpopular learning strategy.
CONCLUSION
Results showed that question writing by students has been found to promote learning when it is implemented as a part of the teaching curriculum in immunology course; therefore, this activity could be effective in improving the students' learning.
| 1significant effect
|
5,215,525 | 27,550,386 |
AIMS
To explore the effects of dual therapy with dapagliflozin and exenatide on body weight, body composition, glycaemic variables and systolic blood pressure (SBP) in obese adults without diabetes.
MATERIALS AND METHODS
In this single-centre, double-blind trial, we randomized 50 obese adults without diabetes (aged 18-70 years; body mass index 30-45 kg/m 2 ) to oral dapagliflozin 10 mg once daily plus subcutaneous long-acting exenatide 2 mg once weekly or placebo. MRI was used to assess change in body composition. Participants were instructed to follow a balanced diet and exercise moderately.
RESULTS
Of 25 dapagliflozin/exenatide- and 25 placebo-treated participants, 23 (92.0%) and 20 (80.0%) completed 24 weeks of treatment, respectively. At baseline, the mean participant age was 52 years, 61% were female, the mean body weight was 104.6 kg, and 73.5% of participants had prediabetes (impaired fasting glucose or impaired glucose tolerance). After 24 weeks, for dapagliflozin/exenatide versus placebo: the difference in body weight change was -4.13 kg (95% confidence interval -6.44, -1.81; P < .001), which was mostly attributable to adipose tissue reduction without lean tissue change; 36.0% versus 4.2% of participants achieved ≥5% body weight loss, respectively; and prediabetes was less frequent with active treatment (34.8% vs 85.0%, respectively; P < .01). The difference in SBP change for dapagliflozin/exenatide versus placebo was -6.7 mm Hg. As expected, nausea and injection-site reactions were more frequent with dapagliflozin/exenatide than with placebo. Only two and three participants, respectively, discontinued because of adverse events.
CONCLUSIONS
Compared with placebo, dapagliflozin/exenatide dual therapy reduced body weight, frequency of prediabetes and SBP over 24 weeks and was well tolerated in obese adults without diabetes.
| 1significant effect
|
4,609,664 | 26,523,141 |
INTRODUCTION
The aim of this study was to compare the formation of dentinal crack and craze lines in the root dentin during root canal preparation with three different NiTi endodontic systems, naming Reciproc (RCP), ProTaper Universal (PTU) and Mtwo.
METHODS AND MATERIALS
One hundred extracted mandibular premolars with single canals were selected and decoronated. The teeth were randomly divided into four groups of 25 each (n=25). In groups 1, 2 and 3 the teeth were prepared using Mtwo, PTU and RCP, respectively. While in group 4 (control group) the samples were left unprepared. After preparation, all specimens were sectioned perpendicular to the long axis of root at 3, 5 and 9-mm distances from the apex. The sections were then individually observed under 12× magnification using stereomicroscope. The data was analyzed using the chi-square and Fisher's exact tests. The level of significance was set at 0.05.
RESULTS
No cracks were observed in the control group. All engine-driven systems caused dentinal cracks. Mtwo and PTU caused cracks significantly more than RCP (P<0.05). There was no significant difference between RCP and control group (P>0.05).
CONCLUSION
All three engine-driven systems created dentinal defects. Reciproc caused less cracks than Mtwo and ProTaper Universal.
| 0no significant effect
|
3,898,240 | 24,423,117 |
BACKGROUND
High density lipoproteins (HDL) have many cardioprotective roles; however, in subjects with type 2 diabetes (T2D) these cardioprotective properties are diminished. Conversely, increased fruit and vegetable (F&V) intake may reduce cardiovascular disease risk, although direct trial evidence of a mechanism by which this occurs in subjects with T2D is lacking. Therefore, the aim of this study was to examine if increased F&V consumption influenced the carotenoid content and enzymes associated with the antioxidant properties of HDL in subjects with T2D.
METHODS
Eighty obese subjects with T2D were randomised to a 1- or ≥6-portion/day F&V diet for 8-weeks. Fasting serum was collected pre- and post-intervention. HDL was subfractionated into HDL2 and HDL3 by rapid ultracentrifugation. Carotenoids were measured in serum, HDL2 and HDL3 by high performance liquid chromatography. The activity of paraoxonase-1 (PON-1) was measured in serum, HDL2 and HDL3 by a spectrophotometric assay, while the activity of lecithin cholesterol acyltransferase (LCAT) was measured in serum, HDL2 and HDL3 by a fluorometric assay.
RESULTS
In the ≥6- vs. 1-portion post-intervention comparisons, carotenoids increased in serum, HDL2 and particularly HDL3, (α-carotene, p = 0.008; β-cryptoxanthin, p = 0.042; lutein, p = 0.012; lycopene, p = 0.016), as did the activities of PON-1 and LCAT in HDL3 (p = 0.006 and 0.044, respectively).
CONCLUSION
To our knowledge, this is the first study in subjects with T2D to demonstrate that increased F&V intake augmented the carotenoid content and influenced enzymes associated with the antioxidant properties of HDL. We suggest that these changes would enhance the cardioprotective properties of this lipoprotein.
CLINICAL TRIAL REGISTRATION
ISRCTN21676269.
| 1significant effect
|
4,731,528 | 26,843,872 |
INTRODUCTION
This in vitro study assessed and compared the cytotoxicity of mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM) cement, Biodentine (BD) and octacalcium phosphate (OCP) on stem cells of the human apical papilla (SCAP).
METHODS AND MATERIALS
SCAPs were isolated from two semi-impacted third molars. The cells were cultured in wells of an insert 24-well plate and were then incubated. The plates were then removed from the incubator and randomly divided into four experimental groups that were exposed to 1-mm discs of set MTA, CEM, BD or OCP, and one untreated control group. After 24, 48 and 168 h, the plates were removed from the incubator and 3-[4, 5-dimethylthiazol-2-yl]-2, 5-diphenyl tetrazolium bromide (MTT) solution was added to each well. Data were analyzed at different time points using the repeated measures ANOVA followed by Bonferroni test and the level of significance was set at 0.05.
RESULTS
Cytotoxicity of the four materials was not significantly different from that of the control group at 24, 48 and 168 h (P>0.05). Two-by-two comparison revealed that cytotoxicity of MTA and CEM cement was significantly different from each other at 168 h (P<0.05) although the cytotoxicity of CEM was less than MTA. Cytotoxicity of OCP and MTA was also significantly different from each other at 48 h and OCP had more favorable biocompatibility than MTA (P<0.05).
CONCLUSION
CEM, OCP, BD and MTA showed acceptable biocompatibility when exposed to SCAP. Over time, CEM showed the least cytotoxicity among the materials under study.
| 0no significant effect
|
5,868,223 | 29,619,388 |
INTRODUCTION
Undiagnosed and uncorrected refractive errors in childhood can negatively affect the development of vision and cause students to have low academic success and even quit school before graduation. This study aims to determine the effects of an eye health promotion program on the health protective behaviors of primary school students.
MATERIALS AND METHODS
This experimental study using a pretest-posttest design with a control group was conducted in three public primary schools in Aydın, a city in the Western Anatolia Region of Turkey, between April and November 2014. The eye health promotion program was provided by the researchers to the experimental Group 2 days in 4 weeks. The data were analyzed using the t -test, Chi-square analysis, the Mann-Whitney U-test, the Wilcoxon signed-rank test, and the McNemar test.
RESULTS
The average age of the students was identified as 9.0 ± 3.64 years. The students wearing glasses all in the experimental group and 53.3% in the control group were found to always wear their glasses after the education program was completed ( P < 0.05). These students, 97.9% in the experimental group and 58.1% in the control group underwent eye examinations from an ophthalmologist ( P < 0.05). The eye health protective behaviors of the experimental group were found to have positively changed in the final follow-up, compared to the control group ( P < 0.05).
CONCLUSION
The eye health promotion program was found to be effective in improving eye health protective behaviors within the experimental group.
| 1significant effect
|
5,911,298 | 29,707,019 |
INTRODUCTION
The aim of the present ex vivo research was to compare the remaining filling material and the volumes of dentine removed after retreatment of curved canals with two rotary systems naming ProTaper Universal Retreatment and Mani NRT-GPR using micro-computed tomography (micro-CT).
METHODS AND MATERIAL
Forty mandibular molars containing two completely separated canals, with curvature angle of 25-35 ° and a curvature radius <10 mm were prepared to the Mtwo instrument 35/0.04 and filled with warm gutta-percha and AH-Plus sealer. The teeth were randomly divided into 2 groups ( n =20), according to the retreatment system evaluated: ProTaper Universal Retreatment (PR group) or Mani NRT-GPR (MR group). Retreatment was considered complete when the working length was reached and when smooth dentinal walls were observed, with no evidence of filling material adhered to instruments or in the irrigating solution. Preoperative and postoperative micro-CT images were obtained with an isotropic voxel size of 11.88 µm to observe the volume of residual filling material in the canals and dentine removed after retreatment. Statistical analysis was performed by Student's t -test ( P <0.05).
RESULTS
The mean percentage of remaining filling material was 12.96% for PR group and 24.26% for MR group ( P =0.0056). The percentage of dentin removal was greater in the PR group (5.02%) than MR group (1.36%) ( P =0.0028). Both systems failed to completely remove the filling material from the canals.
CONCLUSION
ProTaper Universal Retreatment system was more effective than Mani NRT-GPR system regarding removal of root filling material and also removed significantly more dentine after retreatment of curved mesial root canals of mandibular molars.
| 1significant effect
|
5,119,624 | 27,895,500 |
OBJECTIVES
Talimogene laherparepvec is the first oncolytic immunotherapy to receive approval in Europe, the USA and Australia. In the randomized, open-label Phase III OPTiM trial (NCT00769704), talimogene laherparepvec significantly improved durable response rate (DRR) versus granulocyte-macrophage colony-stimulating factor (GM-CSF) in 436 patients with unresectable stage IIIB-IVM1c melanoma. The median overall survival (OS) was longer versus GM-CSF in patients with earlier-stage melanoma (IIIB-IVM1a). Here, we report a detailed subgroup analysis of the OPTiM study in patients with IIIB-IVM1a disease.
PATIENTS AND METHODS
The patients were randomized (2:1 ratio) to intralesional talimogene laherparepvec or subcutaneous GM-CSF and were evaluated for DRR, overall response rate (ORR), OS, safety, benefit-risk and numbers needed to treat. Descriptive statistics were used for subgroup comparisons.
RESULTS
Among 249 evaluated patients with stage IIIB-IVM1a melanoma, DRR was higher with talimogene laherparepvec compared with GM-CSF (25.2% versus 1.2%; P <0.0001). ORR was also higher in the talimogene laherparepvec arm (40.5% versus 2.3%; P <0.0001), and 27 patients in the talimogene laherparepvec arm had a complete response, compared with none in GM-CSF-treated patients. The incidence rates of exposure-adjusted adverse events (AE) and serious AEs were similar with both treatments.
CONCLUSION
The subgroup of patients with stage IIIB, IIIC and IVM1a melanoma (57.1% of the OPTiM intent-to-treat population) derived greater benefit in DRR and ORR from talimogene laherparepvec compared with GM-CSF. Talimogene laherparepvec was well tolerated.
| 1significant effect
|
5,331,731 | 28,245,877 |
BACKGROUND
Performance-based financing (PBF) has been implemented in a number of countries with the aim of transforming health systems and improving maternal and child health. This paper examines the effect of PBF on health workers' job satisfaction, motivation, and attrition in Zambia. It uses a randomized intervention/control design to evaluate before-after changes for three groups: intervention (PBF) group, control 1 (C1; enhanced financing) group, and control 2 (C2; pure control) group.
METHODS
Mixed methods are employed. The quantitative portion comprises of a baseline and an endline survey. The survey and sampling scheme were designed to allow for a rigorous impact evaluation of PBF or C1 on several key performance indicators. The qualitative portion seeks to explain the pathways underlying the observed differences through interviews conducted at the beginning and at the three-year mark of the PBF program.
RESULTS
Econometric analysis shows that PBF led to increased job satisfaction and decreased attrition on a subset of measures, with little effect on motivation. The C1 group also experienced some positive effects on job satisfaction. The null results of the quantitative assessment of motivation cohere with those of the qualitative assessment, which revealed that workers remain motivated by their dedication to the profession and to provide health care to the community rather than by financial incentives. The qualitative evidence also provides two explanations for higher overall job satisfaction in the C1 than in the PBF group: better working conditions and more effective supervision from the District Medical Office. The PBF group had higher satisfaction with compensation than both control groups because they have higher compensation and financial autonomy, which was intended to be part of the PBF intervention. While PBF could not address all the reasons for attrition, it did lower turnover because those health centers were staffed with qualified personnel and the personnel had role clarity.
CONCLUSIONS
In Zambia, the implementation of PBF schemes brought about a significant increase in job satisfaction and a decrease in attrition, but had no significant effect on motivation. Enhanced health financing also increased stated job satisfaction.
| 1significant effect
|
4,667,406 | 26,628,263 |
BACKGROUND
Chronic pelvic pain is a common condition among women, and 10 to 30 % of causes originate from the abdominal wall, and are associated with trigger points. Although little is known about their pathophysiology, variable methods have been practiced clinically. The purpose of this study was to evaluate the efficacy of local anaesthetic injections versus ischemic compression via physical therapy for pain relief of abdominal wall trigger points in women with chronic pelvic pain.
METHODS
We conducted a parallel group randomized trial including 30 women with chronic pelvic pain with abdominal wall trigger points. Subjects were randomly assigned to one of two intervention groups. One group received an injection of 2 mL 0.5 % lidocaine without a vasoconstrictor into a trigger point. In the other group, ischemic compression via physical therapy was administered at the trigger points three times, with each session lasting for 60 s, and a rest period of 30 s between applications. Both treatments were administered during one weekly session for four weeks. Our primary outcomes were satisfactory clinical response rates and percentages of pain relief. Our secondary outcomes are pain threshold and tolerance at the trigger points. All subjects were evaluated at baseline and 1, 4, and 12 weeks after the interventions. The study was conducted at a tertiary hospital that was associated with a university providing assistance predominantly to working class women who were treated by the public health system.
RESULTS
Clinical response rates and pain relief were significantly better at 1, 4, and 12 weeks for those receiving local anaesthetic injections than ischemic compression via physical therapy. The pain relief of women treated with local anaesthetic injections progressively improved at 1, 4, and 12 weeks after intervention. In contrast, women treated with ischemic compression did not show considerable changes in pain relief after intervention. In the local anaesthetic injection group, pain threshold and tolerance improved with time in the absence of significant differences between groups.
CONCLUSION
Lidocaine injection seems to be better for reducing the severity of chronic pelvic pain secondary to abdominal wall trigger points compared to ischemic compression via physical therapy.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00628355. Date of registration: February 25, 2008.
| 1significant effect
|
3,894,078 | 24,478,949 |
BACKGROUND
Toothbrushes are rapidly contaminated with different microorganisms representing a possible cause of infection or reinfection especially in the periodontal patients under therapy. The purpose of this study was to evaluate the sanitization of toothbrushes previously contaminated by various oral microorganisms using a domestic microwave oven and commercial ultraviolet (UV) light toothbrush sanitizer.
MATERIALS AND METHODS
Thirty male dental graduates were randomly assigned to control or experimental groups and received standardized toothbrushes for home use. Each subject was instructed to use it with the standardized modified Bass technique for 1 week and submit it to the investigator after use. Collected toothbrushes were cultured and analyzed for the number of colony-forming units (CFUs). In the next phase, once again a new set of toothbrush was given to each subject and instructed to use it for one more week and follow the same instructions as given earlier. Subsequently, the used toothbrushes were again collected and were sanitized by microwave irradiation, UV radiation, or were not sanitized (control group). After the sanitization procedure, toothbrushes were again cultured for the number of CFUs. The collected data of the presanitized and postsanitized CFU count were log transformed to normalize their distributions prior to analysis. Furthermore, log CFU data were compared and analyzed by one-way ANOVA, Tukey's post hoc procedure, and paired t-test for the difference in the mean at P<0.05.
RESULTS
Result showed that after the sanitization procedure, there was a significant (P<0.001) reduction in microbial contamination in both microwave and UV group toothbrushes compared to control group toothbrushes whereas the microbial count in the microwave group was significantly less (P<0.001) compared to the UV group.
CONCLUSIONS
The evidence presented in this study suggests that microwave irradiation is an effective disinfectant agent for bacteria and fungi on toothbrushes.
| 1significant effect
|
4,399,299 | 25,664,602 |
CONTEXT
Although dipeptidyl-peptidase-4 inhibitors exert their major action via an incretin mechanism, a favorable effect of vildagliptin on lipid metabolism remains unexplained.
OBJECTIVE
The objective was to examine hepatic triglyceride levels and insulin sensitivity on vildagliptin.
DESIGN
This was a 6-month, randomized, double-blind, placebo-controlled trial.
SETTING
This was an outpatient study at a university clinical research center.
PATIENTS
Individuals with type 2 diabetes (n = 44) and glycated hemoglobin ≤ 7.6% on stable metformin therapy were included.
INTERVENTION
Intervention was vildagliptin 50 mg twice a day or placebo over 6 months.
MAIN OUTCOME MEASURES
Main outcome measures were hepatic triglyceride levels and insulin sensitivity.
RESULTS
Mean fasting liver triglyceride content decreased by 27% with vildagliptin, from 7.3 ± 1.0% (baseline) to 5.3 ± 0.9% (endpoint). There was no change in the placebo group. The between-group difference in change from baseline was significant (P = .013). Mean fasting plasma glucose concentration decreased over the study period with vildagliptin vs placebo by -1.0 mmol/L (P = .018), and there was a positive correlation between these decrements and liver triglyceride in the vildagliptin group at 3 months (r = 0.47; P = .02) and 6 months (r = 0.44; P = .03). Plasma alanine aminotransferase fell from 27.2 ± 2.8 to 20.3 ± 1.4 IU/L in the vildagliptin group (P = .0007), and there was a correlation between the decrements in alanine aminotransferase and liver triglyceride (r = 0.83; P < .0001). Insulin sensitivity during the euglycemic clamp was similar in each group at baseline (3.24 ± 0.30 vs 3.19 ± 0.38 mg/kg/min) and did not change (adjusted mean change of 0.26 ± 0.22 vs 0.32 ± 0.22 mg/kg/min; P = .86). Mean body weight decreased by 1.6 ± 0.5 vs 0.4 ± 0.5 kg in the vildagliptin and placebo groups, respectively (P = .08).
CONCLUSIONS
This study demonstrates that the dipeptidyl-peptidase-4 inhibitor vildagliptin brings about a clinically significant decrease in hepatic triglyceride levels during 6 months of therapy unrelated to change in body weight. There was no change in peripheral insulin sensitivity.
| 1significant effect
|
3,685,524 | 23,742,058 |
BACKGROUND
Emissions from biomass combustion are a major source of indoor and outdoor air pollution, and are estimated to cause millions of premature deaths worldwide annually. Whilst adverse respiratory health effects of biomass exposure are well established, less is known about its effects on the cardiovascular system. In this study we assessed the effect of exposure to wood smoke on heart rate, blood pressure, central arterial stiffness and heart rate variability in otherwise healthy persons.
METHODS
Fourteen healthy non-smoking subjects participated in a randomized, double-blind crossover study. Subjects were exposed to dilute wood smoke (mean particle concentration of 314±38 μg/m3) or filtered air for three hours during intermittent exercise. Heart rate, blood pressure, central arterial stiffness and heart rate variability were measured at baseline and for one hour post-exposure.
RESULTS
Central arterial stiffness, measured as augmentation index, augmentation pressure and pulse wave velocity, was higher after wood smoke exposure as compared to filtered air (p < 0.01 for all), and heart rate was increased (p < 0.01) although there was no effect on blood pressure. Heart rate variability (SDNN, RMSSD and pNN50; p = 0.003, p < 0.001 and p < 0.001 respectively) was decreased one hour following exposure to wood smoke compared to filtered air.
CONCLUSIONS
Acute exposure to wood smoke as a model of exposure to biomass combustion is associated with an immediate increase in central arterial stiffness and a simultaneous reduction in heart rate variability. As biomass is used for cooking and heating by a large fraction of the global population and is currently advocated as a sustainable alternative energy source, further studies are required to establish its likely impact on cardiovascular disease.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT01488500.
| 1significant effect
|
5,434,591 | 28,287,004 |
Background and purpose - Aseptic loosening is a main cause of late revision in total knee replacement (TKR). Migration of implants as measured by radiostereometric analysis (RSA) can predict future loosening. This migration is associated with bone resorption. Denosumab is a human monoclonal antibody that binds to receptors on osteoclast precursors and osteoclasts. This prevents osteoclast formation, resulting in less bone resorption in cortical and trabecular bone. We investigated whether denosumab can reduce migration of TKR, as measured with RSA. Patients and methods - In this 2-center, randomized, double-blind placebo-controlled trial, 50 patients with osteoarthritis of the knee were treated with an injection of either denosumab (60 mg) or placebo 1 day after knee replacement surgery and again after 6 months. RSA was performed postoperatively and after 6, 12, and 24 months. The primary effect variable was RSA maximal total point motion (MTPM) after 12 months. We also measured other RSA variables and the knee osteoarthritis outcome score (KOOS). Results - The primary effect variable, MTPM after 12 months, showed that migration in the denosumab group was statistically significantly less than in the controls. Denosumab MTPM 12 months was reduced by one-third (denosumab: median 0.24 mm, 10% and 90% percentiles: 0.15 and 0.41; placebo: median 0.36 mm, 10% and 90% percentiles: 0.20 and 0.62). The secondary MTPM variables (6 and 24 months) also showed a statistically significant reduction in migration. There was no significant difference in MTPM for the period 12-24 months. KOOS sub-variables were similiar between denosumab and placebo after 12 and 24 months. Interpretation - Denosumab reduces early migration in total knee replacement, as in previous trials using bisphosphonates. As migration is related to the risk of late loosening, denosumab may be beneficial for long-term results.
| 1significant effect
|
3,263,438 | 22,267,687 |
Background Fluticasone furoate/vilanterol (FF/VI) is a novel once-daily (OD) inhaled corticosteroid/long-acting β(2) agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma. Trial design A multicentre, randomised, double-blind, parallel-group, placebo-controlled study. Methods Participants were patients with moderate-to-severe COPD treated with placebo or FF/VI 400/25 μg OD for 4 weeks. Study objectives were to assess the safety and efficacy of FF/VI 400/25 μg OD administered for 4 weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0-4 h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV(1)) (23-24 h postdose; day 29) and wm FEV(1) (0-4 h postdose; day 28). Patients were randomised to receive FF/VI 400/25 μg or placebo in a 2:1 ratio; all patients and investigators were blinded to active or placebo treatment. Results 60 patients (mean age 64 years) were randomised (FF/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV(1) per cent predicted was comparable between groups (FF/VI: 58.5%; placebo: 60.1%). The wm heart rate 0-4 h postdose was similar between groups (difference: 0.6 beats per minute; 95% CI -3.9 to 5.1). More on-treatment AEs were reported in the FF/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs/Holters. The FF/VI group had statistically greater improvements compared with placebo in trough FEV(1) (mean difference 183 ml) and 0-4 h postdose wm FEV(1) (mean difference 236 ml). Conclusion FF/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD. Trial registration number clinical trials.gov-NCT00731822.
| 0no significant effect
|
3,417,877 | 22,915,933 |
BACKGROUND
Cellulose masks obtained from natural sources such as bacteria are of interest as cosmetic devices for the treatment of dry skin because they not only improve hydration of the skin, but have low toxicity and are biodegradable. The aims of this study were to determine the in vivo effects of a cellulose mask obtained from Acetobacter xylinum on skin characteristics and to evaluate user satisfaction with the product.
METHODS
Thirty healthy Thai volunteers aged 21-40 years participated in the study. The volunteers were randomly separated into a control group and an experimental group. For the control group, volunteers were assigned to apply moist towels to the face for 25 minutes. For the experimental group, the volunteers were assigned to apply the masks, ie, translucent patches which could be fitted onto the face for the same period. The following week, the groups were changed over to the alternative treatment. Skin moisture, sebum, elasticity, texture, dullness, and desquamation levels were assessed using a system used for routine skin counseling before applying the trial product and five minutes after its removal. Degree of satisfaction with use of the cellulose mask was investigated using a five-point rating scale.
RESULTS
The cellulose mask increased moisture levels in the skin significantly more than moist towels (P < 0.05) after a single application. No obvious effects on other skin characteristics were found. The cellulose mask product rated around 4/5 on the satisfaction rating scale.
CONCLUSIONS
A single application of the trial cellulose mask enhanced moisture uptake by facial skin. Users also reported being satisfied with the trial product.
| 0no significant effect
|
2,949,642 | 20,649,975 |
INTRODUCTION
The HOXB13:IL17BR index has been identified to predict clinical outcome in the setting of adjuvant tamoxifen monotherapy of breast cancer. Further studies have shown that HOXB13 in particular can indicate benefit of prolonged tamoxifen treatment. Patients with high-expressing tumors did not benefit from prolonged treatment, suggesting that HOXB13 might be involved in tamoxifen resistance. No studies have been made regarding the HOXB13 protein levels in breast cancer. The aim of our study was to investigate whether tamoxifen benefit can be correlated to different levels of HOXB13 protein expression.
METHODS
We used immunohistochemistry to analyze protein levels of HOXB13 in tumor samples from 912 postmenopausal node-negative breast cancer patients randomized to adjuvant tamoxifen therapy or no endocrine treatment.
RESULTS
Tamoxifen-treated patients with estrogen receptor-positive tumors expressing none or low levels of HOXB13 had a clear benefit from tamoxifen in terms of longer distant recurrence-free survival (DRFS) (hazard ratio = 0.38, 95% confidence interval = 0.23 to 0.60, P = 0.000048). However, for patients with a high or intermediate HOXB13 tumor expression, tamoxifen did not prolong the DRFS compared with the untreated patients (hazard ratio = 0.88, 95% confidence interval = 0.47 to 1.65, P = 0.69). Interaction between HOXB13 expression and benefit from tamoxifen was statistically significant for DRFS (P = 0.035). No prognostic value could be ascribed to HOXB13 among systemically untreated patients.
CONCLUSIONS
A high HOXB13 expression was associated with decreased benefit from tamoxifen, which indicates that HOXB13 protein level may be used as a predictive marker for tamoxifen treatment.
| 1significant effect
|
3,219,771 | 22,110,878 |
BACKGROUND
Carbon dioxide (CO(2)) has different biophysical properties under different thermal conditions, which may affect its rate of absorption in the blood and the related adverse events. The present study was aimed to investigate the effects of heating of CO(2) on acid-base balance using Stewart's physiochemical approach, and body temperature during laparoscopy.
METHODS
Thirty adult patients undergoing laparoscopic major abdominal surgery were randomized to receive either room temperature CO(2) (control group, n = 15) or heated CO(2) (heated group, n = 15). The acid-base parameters were measured 10 min after the induction of anesthesia (T1), 40 min after pneumoperitoneum (T2), at the end of surgery (T3) and 1 h after surgery (T4). Body temperature was measured at 15-min intervals until the end of the surgery.
RESULTS
There were no significant differences in pH, PaCO(2), the apparent strong ion difference, the strong ion gap, bicarbonate ion, or lactate between two groups throughout the whole investigation period. At T2, pH was decreased whereas PaCO(2) was increased in both groups compared with T1 but these changes were not significantly different. Body temperatures in the heated group were significantly higher than those in the control group from 30 to 90 min after pneumoperitoneum.
CONCLUSIONS
The heating of insufflating CO(2) did not affect changes in the acid-base status and PaCO(2) in patients undergoing laparoscopic abdominal surgery when the ventilator was set to maintain constant end-tidal CO(2). However, the heated CO(2) reduced the decrease in the core body temperature 30 min after the pneumoperitoneum.
| 0no significant effect
|
5,103,135 | 27,882,023 |
OBJECTIVE
To evaluate the effects of bisoprolol combined with trimetazidine on the treatment of heart failure patients having concomitant chronic obstructive pulmonary disease (COPD); in comparison with control group treated with standard therapy only.
METHODS
A total of 120 heart failure patients having concomitant COPD were selected and randomly divided into a control group and a treatment group according to different treatment methods (n=60). The control group was given continuous low flow oxygen inhalation and inotropic agents, and their cardiac stress was also reduced. The treatment group was treated with bisoprolol fumarate and trimetazidine in addition to treatment for COPD. For all patients, blood gas analysis and parameters reflecting cardiac function were measured respectively before and after treatment. The respiratory symptoms (cough, sputum, polypnea, gasp, dyspnea), limitation of motion (daily life, household duties, entertainment, sports), disease impacts (social contact, emotion, anxiety) and St. George's Respiratory Questionnaire (SGRQ) total scores were observed using SGRQ.
RESULTS
The oxygen partial pressure (PaO 2 ) and partial pressure of carbon dioxide (PaCO 2 ) of the treatment group after treatment were significantly different from those before treatment. After treatment, peak E, E/A and IVEF were increased by 41%, 44% and 16% respectively, but peak A, LVPWT/mm and IVST/mm were significantly reduced. The differences in the respiratory symptoms, limitation of motion, disease impacts and SGRQ total scores were statistically significant compared with those before treatment (P<0.05) and those of the control group (P<0.05).
CONCLUSION
Combining bisoprolol with trimetazidine in the treatment of heart failure complicating COPD can effectively improve blood gas indices, left ventricular systolic and diastolic functions and the quality of life, thereby alleviating clinical symptoms.
| 1significant effect
|
3,682,900 | 23,731,573 |
BACKGROUND
Patients admitted to the emergency room with renal impairment and undergoing a contrast computed tomography (CT) are at high risk of developing contrast nephropathy as emergency precludes sufficient hydration prior to contrast use. The value of an ultra-high dose of intravenous N-acetylcysteine in this setting is unknown.
METHODS
From 2008 to 2010, we randomized 120 consecutive patients admitted to the emergency room with an estimated clearance lower than 60 ml/min/1.73 m2 by MDRD (mean GFR 42 ml/min/1.73 m2) to either placebo or 6000 mg N-acetylcysteine iv one hour before contrast CT in addition to iv saline. Serum cystatin C and creatinine were measured one hour prior to and at day 2, 4 and 10 after contrast injection. Nephrotoxicity was defined either as 25% or 44 μmol/l increase in serum creatinine or cystatin C levels compared to baseline values.
RESULTS
Contrast nephrotoxicity occurred in 22% of patients who received placebo (13/58) and 27% of patients who received N-acetylcysteine (14/52, p = 0.66). Ultra-high dose intravenous N-acetylcysteine did not alter creatinine or cystatin C levels. No secondary effects were noted within the 2 groups during follow-up.
CONCLUSIONS
An ultra-high dose of intravenous N-acetylcysteine is ineffective at preventing nephrotoxicity in patients with renal impairment undergoing emergency contrast CT.
TRIAL REGISTRATION
The study was registered as Clinical trial (NCT01467154).
| 0no significant effect
|
3,980,039 | 24,585,202 |
AIMS/HYPOTHESIS
In rodent models of diabetes, treatment with sodium glucose co-transporter 2 (SGLT2) inhibitors improves beta cell function. This analysis assessed the effects of the SGLT2 inhibitor, canagliflozin, on model-based measures of beta cell function in patients with type 2 diabetes.
METHODS
Data from three Phase 3 studies were analysed, in which: (Study 1) canagliflozin 100 and 300 mg were compared with placebo as monotherapy for 26 weeks; (Study 2) canagliflozin 100 and 300 mg were compared with placebo as add-on to metformin + sulfonylurea for 26 weeks; or (Study 3) canagliflozin 300 mg was compared with sitagliptin 100 mg as add-on to metformin + sulfonylurea for 52 weeks. In each study, a subset of patients was given mixed-meal tolerance tests at baseline and study endpoint, and model-based beta cell function parameters were calculated from plasma glucose and C-peptide.
RESULTS
In Studies 1 and 2, both canagliflozin doses increased beta cell glucose sensitivity compared with placebo. Placebo-subtracted least squares mean (LSM) (SEM) changes were 23 (9) and 18 (9) pmol min(-1) m(-2) (mmol/l)(-1) with canagliflozin 100 and 300 mg, respectively (p < 0.002, Study 1), and 16 (8) and 10 (9) pmol min(-1) m(-2) (mmol/l)(-1) (p < 0.02, Study 2). In Study 3, beta cell glucose sensitivity was minimally affected, but the insulin secretion rate at 9 mmol/l glucose increased to similar degrees from baseline with canagliflozin and sitagliptin [LSM (SEM) changes 38 (8) and 28 (9) pmol min(-1) m(-2), respectively; p < 0.05 for both].
CONCLUSIONS/INTERPRETATION
Treatment with canagliflozin for 6 to 12 months improved model-based measures of beta cell function in three separate Phase 3 studies.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01081834 (Study 1); NCT01106625 (Study 2); NCT01137812 (Study 3).
| 1significant effect
|
3,669,111 | 23,705,925 |
BACKGROUND
Elevated serum level of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients.
OBJECTIVES
The CUPID study compared the efficacy of a cinacalcet-based regimen with conventional care (vitamin D and P binders) for achieving the stringent NKF-K/DOQI targets for peritoneal dialysis (PD) patients. Additionally, we analyzed change in FGF23 levels between two treatments to explore the cinacalcet effect in lowering FGF23.
DESIGN
Multicenter, open-labeled, randomized controlled study.
SETTING
Seven university-affiliated hospitals in Korea.
PARTICIPANTS
Overall, 66 peritoneal dialysis patients were enrolled.
INTERVENTION
Sixty six patients were randomly assigned to treatment with either cinacalcet + oral vitamin D (cinacalcet group, n = 33) or oral vitamin D alone (control group, n = 33) to achieve K/DOQI targets. CUPID included a 4-week screening for vitamin D washout, a 12-week dose-titration, and a 4-week assessment phases. We calculated mean values of iPTH, Ca, P, Ca x P, during assessment phase and final FGF23 to assess the outcome.
MAIN OUTCOME MEASURES
Achievement of >30% reduction of iPTH from baseline (primary) and FGF23 reduction (secondary).
RESULTS
72.7% (n = 24) of the cinacalcet group and 93.9% (n = 31) of the control group completed the study. Cinacalcet group received 30.2 ± 18.0 mg/day of cinacalcet and 0.13 ± 0.32 μg/d oral vitamin D (P < 0.001 vs. control with 0.27 ± 0.18 μg/d vitamin D). The proportion of patients who reached the primary endpoint was not statistically different (48.5% vs. 51.5%, cinacalcet vs. control, P = 1.000). After treatment, cinacalcet group experienced a significant reduction in FGF23 levels (median value from 3,960 to 2,325 RU/ml, P = 0.002), while an insignificant change was shown for control group (from 2,085 to 2,415 RU/ml). The percent change of FGF23 after treatment was also significantly different between the two groups (- 42.54% vs. 15.83%, P = 0.008). After adjustment, cinacalcet treatment was independently associated with the serum FGF23 reduction.
CONCLUSION
Cinacalcet treatment was independently associated with the reduction of FGF23 in our PD patients.
TRIAL REGISTRATION
Controlled trials NCT01101113.
| 0no significant effect
|
5,718,865 | 29,238,501 |
BACKGROUND
Childbirth and puerperium are of the most important periods in women's lives and can affect different aspects of their lives.
OBJECTIVE
To determine the effect of perineal massage in the second stage of labor on perineal lacerations, episiotomy, and perineal pain in nulliparous women.
METHODS
This randomization clinical trial was conducted at Be'sat Hospital in Sanandaj, Iran, from 2013 to 2014. A total of 195 nulliparous women were included in the study. The participants were selected through convenience sampling, and randomly assigned to two groups: intervention and control groups. The intervention group received 30-minute perineal massage during second stage of labor. Subsequently, we analyzed perineal laceration, episiotomy, and perineal pain among the two groups. All of them were taught about postpartum perineal pain and its severity, and the researcher followed them up 3 days, 10 days, and 3 months after childbirth by telephone. The data were analyzed using SPSS version 18. We used descriptive statistics and analytical statistics, including t test, Chi-square test, and Fisher's test.
RESULTS
Frequency of episiotomy was 69.47% in the intervention group and 92.31% in the control group, and the difference was statistically significant (p<0.05). The results revealed 23.16% of first-degree perineal laceration and 2.11% of second-degree perineal laceration in the intervention group, and no vestibular laceration or third- and fourth-degree lacerations in the intervention group. However, there were 5.13% of vestibular laceration, 7.69% of first-degree laceration, 2.56% of second-degree laceration, and 1.05% of third-degree laceration (one woman) in the control group. Based on the results, the postpartum perineal pain was significantly different in both groups.
CONCLUSION
Regarding the results of this study and those of other studies, perineal massage during the second stage of labor can reduce the need to episiotomy, perineal injuries, and perineal pain.
TRIAL REGISTRATION
The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct.ID: IRCT2013090314556N1.
FUNDING
This study received by financial support of Kurdistan University of Medical Sciences, Sanandaj, Iran.
| 1significant effect
|
5,530,360 | 27,799,159 |
OBJECTIVES
To assess baricitinib on patient-reported outcomes (PROs) in patients with moderately to severely active rheumatoid arthritis, who had insufficient response or intolerance to ≥1 tumour necrosis factor inhibitors (TNFis) or other biological disease-modifying antirheumatic drugs (bDMARDs).
METHODS
In this double-blind phase III study, patients were randomised to once-daily placebo or baricitinib 2 or 4 mg for 24 weeks. PROs included the Short Form-36, EuroQol 5-D, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient's Global Assessment of Disease Activity (PtGA), patient's assessment of pain, duration of morning joint stiffness (MJS) and Work Productivity and Activity Impairment Questionnaire-Rheumatoid Arthritis. Treatment comparisons were performed with logistic regression for categorical measures or analysis of covariance for continuous variables.
RESULTS
527 patients were randomised (placebo, 176; baricitinib 2 mg, 174; baricitinib 4 mg, 177). Both baricitinib-treated groups showed statistically significant improvements versus placebo in most PROs. Improvements were generally more rapid and of greater magnitude for patients receiving baricitinib 4 mg than 2 mg and were maintained to week 24. At week 24, more baricitinib-treated patients versus placebo-treated patients reported normal physical functioning (HAQ-DI <0.5; p≤0.001), reductions in fatigue (FACIT-F ≥3.56; p≤0.05), improvements in PtGA (p≤0.001) and pain (p≤0.001) and reductions in duration of MJS (p<0.01).
CONCLUSIONS
Baricitinib improved most PROs through 24 weeks compared with placebo in this study of treatment-refractory patients with previously inadequate responses to bDMARDs, including at least one TNFi. PRO results aligned with clinical efficacy data for baricitinib.
TRIAL REGISTRATION NUMBER
NCT01721044; Results.
| 1significant effect
|
4,183,888 | 24,854,326 |
PURPOSE
Recent years have seen remarkable progress in cancer therapy, although treatment-induced adverse reactions and complications are not uncommon. Approximately 40 % of patients undergoing chemotherapy for cancer experience adverse reactions in the oral cavity, with nearly half of them developing severe oral mucositis that necessitates postponing therapy and/or changing the drug dosage. The objective of this study was to assess the usefulness of prophylactic professional oral health care (POHC) for preventing mucositis in patients undergoing chemotherapy.
METHODS
Twenty-six female patients scheduled for chemotherapy for breast cancer were included in this study and randomized to the self-care or POHC groups. Assessment parameters included oral cavity photographs, plaque control records, Saxon test scores, Oral Assessment Guide scores, and grading using the Common Terminology Criteria for Adverse Events. Beginning before surgery and continuing through the completion of chemotherapy, the POHC patient group received weekly professional oral health care, including scaling, professional cleaning of the tooth surfaces, brushing instructions, and nutritional and lifestyle guidance.
RESULTS
More patients in the self-care group developed oral mucositis than in the POHC group. The Oral Assessment Guide score, which was used as an index of oral mucositis, was also significantly lower in the POHC group. Based on the Oral Assessment Guide and plaque control records, there was almost no deterioration of the oral environment in the POHC group, whereas deterioration was observed in the self-care group.
CONCLUSIONS
These findings demonstrate the efficacy of regular POHC in reducing the risk of oral mucositis in breast cancer patients undergoing chemotherapy.
| 1significant effect
|
4,676,931 | 25,962,410 |
BACKGROUND AND PURPOSE
Depressed mood is a common psychiatric problem associated with Parkinson's disease (PD), and studies have suggested a benefit of rasagiline treatment.
METHODS
ACCORDO (see the ) was a 12-week, double-blind, placebo-controlled trial to evaluate the effects of rasagiline 1 mg/day on depressive symptoms and cognition in non-demented PD patients with depressive symptoms. The primary efficacy variable was the change from baseline to week 12 in depressive symptoms measured by the Beck Depression Inventory (BDI-IA) total score. Secondary outcomes included change from baseline to week 12 in cognitive function as assessed by a comprehensive neuropsychological battery; Parkinson's disease quality of life questionnaire (PDQ-39) scores; Apathy Scale scores; and Unified Parkinson's Disease Rating Scale (UPDRS) subscores.
RESULTS
One hundred and twenty-three patients were randomized. At week 12 there was no significant difference between groups for the reduction in total BDI-IA score (primary efficacy variable). However, analysis at week 4 did show a significant difference in favour of rasagiline (marginal means difference ± SE: rasagiline -5.46 ± 0.73 vs. placebo -3.22 ± 0.67; P = 0.026). There were no significant differences between groups on any cognitive test. Rasagiline significantly improved UPDRS Parts I (P = 0.03) and II (P = 0.003) scores versus placebo at week 12. Post hoc analyses showed the statistical superiority of rasagiline versus placebo in the UPDRS Part I depression item (P = 0.04) and PDQ-39 mobility (P = 0.007) and cognition domains (P = 0.026).
CONCLUSIONS
Treatment with rasagiline did not have significant effects versus placebo on depressive symptoms or cognition in PD patients with moderate depressive symptoms. Although limited by lack of correction for multiple comparisons, post hoc analyses signalled some improvement in patient-rated cognitive and depression outcomes.
| 0no significant effect
|
5,559,992 | 28,852,238 |
OBJECTIVE
The objective of this study is to examine the impact of vary doses of buprenorphine on anxiety symptoms in opioid-dependent inpatients over a 7 days period, using a randomized controlled trial design.
DESIGN
Patients were randomized to three groups.
PATIENTS AND METHODS
Fourteen men who met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for both opioid use disorder and generalized anxiety disorder and were seeking for treatment.
INTERVENTION
Patients obtain dosages of 32 mg or 64 mg or 96 mg of buprenorphine as a single dose only and were treated in a psychiatric inpatient unit. Of 14 subjects; 5 (35.7%) obtained 32 mg, 4 (28.6%) obtained 64 mg, and 5 (35.7%) obtained 96 mg of buprenorphine.
MEASUREMENTS
Administering daily Hamilton Anxiety Rating Scale and interview.
RESULTS
All the patients ended the 7-day treatment time. The results showed a significant reduction in anxiety symptoms within each of the three groups ( P = 0.00), but no difference in outcome between the groups ( P = 0.605).
CONCLUSIONS
The outcome suggests a single high dose of buprenorphine can supply a speedy, safe, simple, and suitable means of anxiety treatment. The single high dose of buprenorphine could be a novel mechanism medication that provides a rapid and sustained improvement for generalized anxiety disorder in opioid dependent patients. Placebo-controlled trials of longer duration are needed to evaluate ability, safety, and psychological and physiological influence of extended exposure to this medication.
| 0no significant effect
|
4,478,821 | 26,240,547 |
BACKGROUND
Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children.
MATERIALS AND METHODS
After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group.
RESULTS
The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766).
CONCLUSION
We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for cataract procedures in children. The surgical condition improved with increasing dose of atracurium from 25% to 100% ED95 dose.
| 0no significant effect
|
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