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3,329,225 | 22,121,130 |
BACKGROUND
Treatment with tumour necrosis factor inhibitors (TNF-i) plus methotrexate (MTX), but not MTX monotherapy alone, inhibits joint damage progression even at higher levels of disease activity. Such disassociation of disease activity and structural damage has not been shown for biological agents other than TNF-i.
OBJECTIVES
To evaluate whether interleukin 6 (IL-6) inhibition with tocilizumab (TCZ) interferes with joint destruction beyond its effects on disease activity.
METHODS
A random 90% sample of data from the (The Tocilizumab Safety and the Prevention of Structural Joint Damage Study) LITHE trial on active rheumatoid arthritis (RA) despite MTX was used, which compared addition of placebo (n=117) with addition of TCZ (n=414) every 4 weeks. Baseline and 1-year values of clinical and serological variables were correlated with changes to 1 year of the total Genant-modified Sharp score (TGSS) using a Spearman test, and the progression of TGSS, erosion and joint space narrowing (JSN) scores in groups with low and high disease activity were compared for placebo and TCZ (Kruskal-Wallis).
RESULTS
Baseline variables were similar among the groups. Change of TGSS was lower in patients receiving TCZ than placebo (TCZ: 0.29 ± 0.96; placebo: 0.90 ± 1.92; p=0.0007). In patients receiving placebo, the correlation with TGSS change was significant for baseline scores of the simplified disease activity index (SDAI; r=0.18, p=0.047) and swollen joint count 28 (r=0.22, p=0.019), with similar trends for C-reactive protein. Similar correlations were seen for SDAI, clinical disease activity index, disease activity score 28 at 1 year with x-ray change during that year (r=0.26-0.28, p=0.002-0.006). In contrast, none of the baseline or 1-year variables showed significant correlation with x-ray changes in patients receiving TCZ+MTX, suggesting a disassociation of the link between disease activity and damage by TCZ. Finally, for patients in remission or with low disease activity, progression of TGSS, erosion and JSN was similar among treatment groups (TGSS: placebo, 0.4±1.1; TCZ, 0.2 ± 0.7; p=NS), while for patients with moderate or high disease activity placebo-treated patients progression was significantly greater (TGSS: 1.2 ± 2.2 vs 0.4 ± 1.2; p=0.0009).
CONCLUSIONS
IL-6 inhibition with TCZ plus MTX retards joint damage progression independently of its impact on disease activity. Similar effects have hitherto been reported only for TNF-i. This indicates that the effects of IL-6 inhibition on progression of joint damage in RA are among the most profound currently attainable.
| 1significant effect
|
5,712,123 | 29,197,345 |
BACKGROUND
Duloxetine, Etoricoxib and opioid are of the commonly administered drugs in Lumbar laminectomy. The aim of this study is to assess the effect of perioperative use of Duloxetine in combination with Etoricoxib on postoperative pain and opioid requirements.
METHODS
One hundred twenty patients with ASA physical status were enrolled with age between 18 and 70 years. Patients were divided randomly into four groups of 30 patients: group P received placebo, group E received etoricoxib 120 mg, group D received duloxetine 60 mg and group D/E received duloxetine 60 mg capsules and etoricoxib 120 mg; 1 h before surgery and 24 h after.
RESULTS
Neither Duloxetine nor etoricoxib individually had effect on pain with movement, while their combination revealed a significant reduction in pain scores over the entire postoperative period at rest and on movement. Etoricoxib showed a significant decrease in pain at all times at rest when compared with group P, while it showed significant pain decrease only at 0, 2 and 4 h when compared with group D. On the other hand duloxetine alone showed significant decrease in pain at rest at 24 h and 48 h when compared with group P. ConcerningMorphine requirement after 24 h.; it wassignificantly lower in the D/E group in comparison with groups P, E and D. It should be noted also that there was a significant decrease morphine requirement in both groups E and D.
CONCLUSION
The perioperative administration of the combination of etoricoxib and duloxetine improved analgesia and reduced opioid consumption without significant side effects.
TRIAL REGISTRATION
ISRCTN48329522 . 17 June 2017.
| 1significant effect
|
4,307,639 | 25,539,637 |
BACKGROUND
Trials aimed at preventing cognitive decline through cognitive stimulation among those with normal cognition or mild cognitive impairment are of significant importance in delaying the onset of dementia and reducing dementia prevalence. One challenge in these prevention trials is sample recruitment bias. Those willing to volunteer for these trials could be socially active, in relatively good health, and have high educational levels and cognitive function. These participants' characteristics could reduce the generalizability of study results and, more importantly, mask trial effects. We developed a randomized controlled trial to examine whether conversation-based cognitive stimulation delivered through personal computers, a webcam and the internet would have a positive effect on cognitive function among older adults with normal cognition or mild cognitive impairment. To examine the selectivity of samples, we conducted a mass mail-in survey distribution among community-dwelling older adults, assessing factors associated with a willingness to participate in the trial.
METHODS
Two thousand mail-in surveys were distributed to retirement communities in order to collect data on demographics, the nature and frequency of social activities, personal computer use and additional health-related variables, and interest in the prevention study. We also asked for their contact information if they were interested in being contacted as potential participants in the trial.
RESULTS
Of 1,102 surveys returned (55.1% response rate), 983 surveys had complete data for all the variables of interest. Among them, 309 showed interest in the study and provided their contact information (operationally defined as the committed with interest group), 74 provided contact information without interest in the study (committed without interest group), 66 showed interest, but provided no contact information (interest only group), and 534 showed no interest and provided no contact information (no interest group). Compared with the no interest group, the committed with interest group were more likely to be personal computer users (odds ratio (OR) = 2.78), physically active (OR = 1.03) and had higher levels of loneliness (OR = 1.16).
CONCLUSION
Increasing potential participants' familiarity with a personal computer and the internet before trial recruitment could increase participation rates and improve the generalizability of future studies of this type.
TRIAL REGISTRATION
The trial was registered on 29 March 2012 at ClinicalTirals.gov (ID number NCT01571427).
| 1significant effect
|
3,176,493 | 21,888,656 |
BACKGROUND
Offspring of women with schistosomiasis may exhibit immune responsiveness to schistosomes due to in utero sensitisation or trans-placental transfer of antibodies. Praziquantel treatment during pregnancy boosts maternal immune responses to schistosome antigens and reduces worm burden. Effects of praziquantel treatment during pregnancy on responses among offspring are unknown.
METHODS
In a trial of anthelminthic treatment during pregnancy in Uganda (ISRCTN32849447; http://www.controlled-trials.com/ISRCTN32849447/elliott), offspring of women with Schistosoma mansoni were examined for cytokine and antibody responses to schistosome worm (SWA) and egg (SEA) antigen, in cord blood and at age one year. Relationships to maternal responses and pre-treatment infection intensities were examined, and responses were compared between the offspring of women who did, or did not receive praziquantel treatment during pregnancy.
RESULTS
Of 388 S. mansoni-infected women studied, samples were obtained at age one year from 215 of their infants. Stool examination for S. mansoni eggs was negative for all infants. Cord and infant samples were characterised by very low cytokine production in response to schistosome antigens with the exception of cord IL-10 responses, which were substantial. Cord and infant cytokine responses showed no association with maternal responses. As expected, cord blood levels of immunoglobulin (Ig) G to SWA and SEA were high and correlated with maternal antibodies. However, by age one year IgG levels had waned and were hardly detectable. Praziquantel treatment during pregnancy showed no effect on cytokine responses or antibodies levels to SWA or SEA either in cord blood or at age one year, except for IgG1 to SWA, which was elevated in infants of treated mothers, reflecting maternal levels. There was some evidence that maternal infection intensity was positively associated with cord blood IL-5 and IL-13 responses to SWA, and IL-5 responses to SEA, and that this association was modified by treatment with praziquantel.
CONCLUSIONS
Despite strong effects on maternal infection intensity and maternal immune responses, praziquantel treatment of infected women during pregnancy had no effect on anti-schistosome immune responses among offspring by age one year. Whether the treatment will impact upon the offspring's responses on exposure to primary schistosome infection remains to be elucidated.
TRIAL REGISTRATION
ISRCTN: ISRCTN32849447.
| 0no significant effect
|
2,759,629 | 19,826,528 |
BACKGROUND
Extra-articular fractures of lower end radius are conventionally immobilized in palmar flexion and ulnar deviation. In view of poor functional results, the conventional method of immobilization is giving way to dorsiflexed-immobilized method. The aim of our study is to evaluate and compare the radiological and functional outcome in extra-articular fractures of lower end radius treated conservatively with respect to its position of immobilization.
MATERIALS AND METHODS
Sixty-four patients, all above 20 years of age with closed extra-articular fractures of lower end radius who were treated conservatively by close reduction and below elbow cast application constitute the clinical material. Irrespective of fracture geometry the patients were randomly allocated to dorsal or palmar flexed immobilized position of wrist. Patients were followed up for a minimum six-month period. The radial tilt, palmar tilt and ulnar variance are measured at prereduction, postreduction and at 6 month followup. The results were scored by Demerit Scoring System of Saito.
RESULTS
All fractures united. Individual movement of dorsiflexion, palmar flexion, supination, pronation and radial-ulnar deviation were all significantly better in the dorsiflexed-immobilized group as compared with the palmar flexed immobilized group. Grip strength recovery with subjective assessment was better in the dorsiflexed group (77%) as compared to the palmar flexed group (23%). Radiological parameters were markedly better in the dorsiflexed group. Ninety-one per cent of patients in the dorsiflexed group had excellent to good results as compared to 66% in the palmar flexed group.
CONCLUSION
Functional results of extra-articular fractures of lower end radius are superior if the fractures after reduction are immobilized in dorsiflexion of wrist rather than in conventional palmar flexion position.
| 1significant effect
|
4,392,433 | 25,792,124 |
BACKGROUND
Vorapaxar is a protease-activated receptor-1 antagonist approved by the U.S. Food and Drug Administration (FDA) for the reduction of thrombotic cardiovascular (CV) events in patients with a history of myocardial infarction (MI) and peripheral artery disease (PAD), without a previous stroke or transient ischemic attack (TIA).
METHODS AND RESULTS
We examined the efficacy and safety of vorapaxar in the intended use population, considering 20,170 patients randomized in the multinational, double-blinded, placebo-controlled TRA 2°P-TIMI 50 trial. Of these, 16,897 qualified with a history of MI in the prior 2 weeks to 1 year and 3273 with PAD. At baseline 97% of the patients were treated with aspirin, 71% with a thienopyridine, and 93% a statin. At 3 years, the endpoint of CV death, MI, or stroke was significantly reduced with vorapaxar compared with placebo (7.9% versus 9.5%, HR, 0.80; 95% CI 0.73 to 0.89; P<0.001). Vorapaxar also significantly reduced the composite of CV death, MI, stroke, and urgent coronary revascularization (10.1% versus 11.8%, HR, 0.83; 95% CI 0.76 to 0.90; P<0.001), as well as the rate of CV death or MI (P<0.001). The safety endpoint of GUSTO moderate or severe bleeding, was increased in the vorapaxar group (3.7 versus 2.4, HR, 1.55; 95% CI 1.30 to 1.86, P<0.001). Intracranial bleeding (ICH) was 0.6% versus 0.4%, P=0.10 with vorapaxar versus placebo, with fatal bleeding 0.2% versus 0.2%; P=0.70.
CONCLUSIONS
In patients with prior MI or PAD who have not had a previous stroke or TIA, vorapaxar added to standard therapy is effective for long-term secondary prevention of thrombotic CV events, while increasing moderate or severe bleeding.
CLINICAL TRIAL REGISTRATION
URL: clinicaltrials.gov Unique Identifier: NCT00526474.
| 1significant effect
|
4,329,409 | 25,302,624 |
OBJECTIVE
To investigate clinical efficacy and safety of 2 certolizumab pegol (CZP) maintenance dosing regimens plus methotrexate (MTX) in active rheumatoid arthritis (RA) patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) after the CZP 200 mg every 2 weeks open-label run-in period.
METHODS
DOSEFLEX (dosing flexibility) was a double-blind, placebo-controlled randomized study with an open-label run-in phase. During the run-in phase, all patients received CZP 400 mg (weeks 0, 2, and 4) and 200 mg every 2 weeks to week 16. Week 16 ACR20 responders were randomized 1:1:1 at week 18 to CZP 200 mg every 2 weeks, 400 mg every 4 weeks, or placebo.
RESULTS
A total of 209 (of 333) patients were randomized at week 18 (CZP: 200 mg, n = 70; 400 mg, n = 70; placebo, n = 69). Groups had similar baseline characteristics (week 0). Week 34 ACR20 response rates were comparable between the CZP 200 mg every 2 weeks and the 400 mg every 4 weeks groups (67.1% versus 65.2%), which was significantly higher than placebo (44.9%; P = 0.009 and P = 0.017). ACR50/70 and remission criteria were met more frequently in CZP groups than placebo at week 34, with similar responses between anti-tumor necrosis factor-experienced and naive patients. Improvements from baseline Disease Activity Score in 28 joints using the erythrocyte sedimentation rate and Health Assessment Questionnaire disability index scores were maintained in CZP groups from week 16 to 34 while worsening on placebo. Adverse event (AE) rates in the double-blind phase were 62.9% versus 60.9% versus 62.3%; serious AE rates were 7.1% versus 2.9% versus 0.0% (CZP 200 mg, 400 mg, and placebo groups).
CONCLUSION
In active RA patients with an incomplete MTX response, CZP 200 mg every 2 weeks and 400 mg every 4 weeks were comparable and better than placebo for maintaining clinical response to week 4 following a 16-week, open-label run-in phase.
| 1significant effect
|
5,019,971 | 27,300,170 |
BACKGROUND
The increased risk of abacavir in cardiovascular disease (CVD) in HIV-infected patients is still being debated. Maraviroc, a CCR5 blocker, has been shown to decrease immune activation and monocyte infiltration in atherosclerotic plaques in murine experiments. Therefore, we examined the effect of maraviroc intensification on flow-mediated dilatation (FMD) in abacavir-treated HIV-infected patients and its effect on immunological and inflammatory parameters.
METHODS
A open-label prospective crossover study with a duration of 16 weeks: 8 weeks of intervention (maraviroc intensification) and 8 weeks of control (unchanged cART regimen). FMD, HIV-specific variables, expression of HIV co-receptors, markers of inflammation and coagulation and cellular markers of immune activation were measured at weeks 0, 8 and 16. The changes (Δ) in these variables were compared between intervention and control periods using non-parametric tests. To evaluate the relation with the change in FMD, linear regression modeling was used.
RESULTS
Twenty-one male patients with suppressed plasma HIV-RNA, on cART, had a known HIV infection for 9.2 years (IQR 6.9-13.5) with abacavir use for 6.5 years (2.8-9.3). A significantly increased FMD of 0.73% (IQR -0.25 to 1.70) was seen after maraviroc intensification compared to a decrease of -0.42% (IQR -1.89 to 0.25; p = 0.049) in the control period. There was a negative relation between ΔFMD with ΔD-dimer (β -22.70, 95% CI -39.27; -6.13, p = 0.011) and ΔCD95+ CD4+ T cells (β -0.16, 95% CI -0.28; -0.04, p = 0.013), adjusted for age and duration of HIV.
CONCLUSION
Maraviroc intensification modestly improves endothelial function in HIV-infected patients on an abacavir-containing regimen.
TRIAL REGISTRATION
NCT01389063.
| 1significant effect
|
3,750,766 | 23,819,466 |
BACKGROUND
Repetitive transcranial magnetic stimulation (rTMS) has shown promise in the alleviation of acute and chronic pain by altering the activity of cortical areas involved in pain sensation. However, current single-coil rTMS technology only allows for effects in surface cortical structures. The ability to affect activity in certain deep brain structures may however, allow for a better efficacy, safety, and tolerability. This study used PET imaging to determine whether a novel multi-coil rTMS would allow for preferential targeting of the dorsal anterior cingulate cortex (dACC), an area always activated with pain, and to provide preliminary evidence as to whether this targeted approach would allow for efficacious, safe, and tolerable analgesia both in a volunteer/acute pain model as well as in fibromyalgia chronic pain patients.
METHODS
Part 1: Different coil configurations were tested in a placebo-controlled crossover design in volunteers (N = 16). Tonic pain was induced using a capsaicin/thermal pain model and functional brain imaging was performed by means of H2(15)O positron emission tomography - computed tomography (PET/CT) scans. Differences in NRS pain ratings between TMS and sham treatment (NRS(TMS)-NRS(placebo)) which were recorded each minute during the 10 minute PET scans. Part 2: 16 fibromyalgia patients were subjected to 20 multi-coil rTMS treatments over 4 weeks and effects on standard pain scales (Brief Pain Inventory, item 5, i.e. average pain NRS over the last 24 hours) were recorded.
RESULTS
A single 30 minute session using one of 3 tested rTMS coil configurations operated at 1 Hz consistently produced robust reduction (mean 70% on NRS scale) in evoked pain in volunteers. In fibromyalgia patients, the 20 rTMS sessions also produced a significant pain inhibition (43% reduction in NRS pain over last 24 hours), but only when operated at 10 Hz. This degree of pain control was maintained for at least 4 weeks after the final session.
CONCLUSION
Multi-coil rTMS may be a safe and effective treatment option for acute as well as for chronic pain, such as that accompanying fibromyalgia. Further studies are necessary to optimize configurations and settings as well as to elucidate the mechanisms that lead to the long-lasting pain control produced by these treatments.
| 1significant effect
|
5,524,701 | 28,765,717 |
BACKGROUND
Conducting simulations of rapidly decompensating patients are a key part of internal medicine (IM) residency training. Traditionally, mannequins have been the simulation tool used in these scenarios.
OBJECTIVE
To compare IM residents' performance and assess realism in specific-simulated decompensating patient scenarios using standardized patients (SPs) as compared to mannequin.
METHODS
Nineteen IM residents were randomized to undergo simulations using either a mannequin or an SP. Each resident in the two groups underwent four different simulation scenarios (calcium channel blocker overdose, severe sepsis, severe asthma exacerbation, and acute bacterial meningitis). Residents completed pretest and post-test evaluations as well as a questionnaire to assess the reality perception (realism score).
RESULTS
Nine residents completed mannequin-based scenarios, whereas 10 completed SP-based scenarios. Improvement in the post-test scores was seen in both groups. However, there were significantly higher post-test scores achieved with SP simulations in three out of the four scenarios ( P =0.01). When compared with the mannequin group, the SP simulation group showed a significantly higher average realism score ( P =0.002).
CONCLUSIONS
Applying SP-based specific-simulation scenarios in IM residency training may result in better performance and a higher sense of a realistic experience by medical residents.
| 1significant effect
|
3,281,341 | 22,371,748 |
INTRODUCTION
The proton pump inhibitor empirical trial, besides the analysis of symptoms, is the main method in the diagnosis of gastro-oesophageal reflux disease-related chest pain. β-Endorphin acts as an endogenous analgesia system. The aim of the study was verify whether β-endorphin plasma level is affected by omeprazole administration and influences the severity of anginal symptoms and outcome of the "omeprazole test" in patients with coronary artery disease (CAD) and chest pain of suspected non-cardiac origin.
MATERIAL AND METHODS
Omeprazole was administered to 48 patients with CAD in a randomized, placebo-controlled, crossover study design. At the beginning of the study, and again after the 14-day omeprazole and placebo treatment, the β-endorphin plasma concentration was determined.
RESULTS
The level of plasma β-endorphin after the administration of omeprazole was significantly greater than at the start of the study and following the placebo. Responders to omeprazole had an average lower β-endorphin plasma concentration than subjects who failed to respond to this therapy. Subjects with symptoms in class III (according to the Canadian Cardiovascular Society classification) after omeprazole administration had a greater β-endorphin plasma level than subjects in class II for anginal symptom severity.
CONCLUSIONS
Fourteen-day therapy with a double omeprazole dose significantly increases the β-endorphin plasma concentration in patients with CAD. Circulating β-endorphin does not seem to be involved in the mechanism for the "omeprazole test" outcome, although an individually different effect on pain threshold cannot be excluded.
| 1significant effect
|
4,237,982 | 25,336,745 |
OBJECTIVE
We aim to characterize the effects on total body fat and distribution of a 1-year intensive lifestyle intervention (ILI) for weight loss in overweight and obese adults with type 2 diabetes and to examine whether changes in adipose tissue (AT) depots were associated with changes in metabolic biomarkers.
RESEARCH DESIGN AND METHODS
Participants were 54 females and 38 males (age 57.8 ± 6.7 years [mean ± SD]; BMI 31.7 ± 3.5 kg/m(2)) enrolled in the Look AHEAD (Action for Health in Diabetes) trial randomized to ILI or diabetes support and education (DSE) from whom baseline and 1-year MRI measures of total AT (TAT) and regional (arm, trunk, leg) AT, including subcutaneous AT (SAT), visceral AT (VAT), and intermuscular AT (IMAT), were acquired. We tested whether mean changes in ILI and DSE were equal and, within groups, whether changes were different from zero. Regression models tested whether changes in AT compartments were associated with metabolic variable changes.
RESULTS
Body weight changed -0.52 ± 3.62 kg (P = 0.31) in DSE and -7.24 ± 5.40 kg (P < 0.0001) in ILI. Mean ILI changes were different from DSE (P < 0.001 for TAT, SAT, and IMAT and P < 0.01 for VAT in females). Within ILI, SAT and VAT decreased in males and females (P < 0.0001), but IMAT was unchanged (0.00 ± 0.54 kg; P = 0.99). In DSE, SAT and VAT did not change, but IMAT increased by 0.46 ± 0.55 kg (P < 0.001). Controlling for weight loss, reduction of specific AT depots was associated with improvement in metabolic biomarkers.
CONCLUSIONS
Weight loss of 7-10% from an ILI over 1 year reduced SAT and VAT and prevented an increase in IMAT. Reductions in AT depots were associated with improvements in biomarkers.
| 1significant effect
|
4,007,144 | 24,716,478 |
BACKGROUND
Evidence from armed conflict settings points to high levels of intimate partner violence (IPV) against women. Current knowledge on how to prevent IPV is limited-especially within war-affected settings. To inform prevention programming on gender-based violence in settings affected by conflict, we evaluated the impact of adding a targeted men's intervention to a community-based prevention programme in Côte d'Ivoire.
METHODS
We conducted a two-armed, non-blinded cluster randomized trial in Côte d'Ivoire among 12 pair-matched communities spanning government-controlled, UN buffer, and rebel-controlled zones. The intervention communities received a 16-week IPV prevention intervention using a men's discussion group format. All communities received community-based prevention programmes. Baseline data were collected from couples in September 2010 (pre-intervention) and follow-up in March 2012 (one year post-intervention). The primary trial outcome was women's reported experiences of physical and/or sexual IPV in the last 12 months. We also assessed men's reported intention to use physical IPV, attitudes towards sexual IPV, use of hostility and conflict management skills, and participation in gendered household tasks. An adjusted cluster-level intention to treat analysis was used to compare outcomes between intervention and control communities at follow-up.
RESULTS
At follow-up, reported levels of physical and/or sexual IPV in the intervention arm had decreased compared to the control arm (ARR 0.52, 95% CI 0.18-1.51, not significant). Men participating in the intervention reported decreased intentions to use physical IPV (ARR 0.83, 95% CI 0.66-1.06) and improved attitudes toward sexual IPV (ARR 1.21, 95% CI 0.77-1.91). Significant differences were found between men in the intervention and control arms' reported ability to control their hostility and manage conflict (ARR 1.3, 95% CI 1.06-1.58), and participation in gendered household tasks (ARR 2.47, 95% CI 1.24-4.90).
CONCLUSIONS
This trial points to the value of adding interventions working with men alongside community activities to reduce levels of IPV in conflict-affected settings. The intervention significantly influenced men's reported behaviours related to hostility and conflict management and gender equitable behaviours. The decreased mean level of IPV and the differences between intervention and control arms, while not statistically significant, suggest that IPV in conflict-affected areas can be reduced through concerted efforts to include men directly in violence prevention programming. A larger-scale trial is needed to replicate these findings and further understand the mechanisms of change.
TRIAL REGISTRATION
clinicaltrials.gov NCT01803932.
| 0no significant effect
|
3,506,492 | 23,033,926 |
BACKGROUND
Experimentally, erythropoietin (EPO) has nephroprotective as well as immunomodulatory properties when administered after ischemic renal injury. We tested the hypothesis that different doses of recombinant human EPO administered to patients after cardiac surgery would minimize kidney lesions and the systemic inflammatory response, thereby decreasing acute kidney injury (AKI) incidence.
METHODS
In this double-blinded randomized control study, 80 patients admitted to the ICU post-cardiac surgery were randomized by computer to receive intravenously isotonic saline (n = 40) versus α-Epoetin (n = 40): either 40000 IU (n = 20) or 20000 IU (n = 20). The study lasted one year. The primary outcome was the change in urinary NGAL concentration from baseline and 48 h after EPO injection. Creatinine, cystatine C and urinary NGAL levels were measured on the day of randomization and 2-4 days after EPO injection. To assess acute inflammatory response, serum cytokines (IL6 and IL8) were measured at randomization and four days after r-HuEPO injection. Patients and care-takers were blinded for the assignment.
RESULTS
No patient was excluded after randomization. Patient groups did not differ in terms of age, gender, comorbidities and renal function at randomization. The rate of AKI assessed by AKIN criteria was 22.5% in our population. EPO treatment did not significantly modify the difference in uNGAl between 48 hours and randomization compared to placebo [2.5 ng/ml (-17.3; 22.5) vs 0.7 ng/ml (-31.77; 25.15), p = 0.77] and the incidence of AKI was similar. Inflammatory cytokines levels were not influenced by EPO treatment. Mortality and hospital stays were similar between the groups and no adverse event was recorded.
CONCLUSION
In this randomized-controlled trial, α-Epoetin administrated after cardiac surgery, although safe, demonstrated neither nephroprotective nor anti-inflammatory properties.
TRIAL REGISTRATION NUMBER
NCT00676234.
| 0no significant effect
|
3,283,075 | 22,384,447 |
OBJECTIVE
To investigate the effectiveness of GnRH antagonist multiple-dose protocol (MDP) with oral contraceptive pill (OCP) pretreatment in poor responders undergoing IVF/ICSI, compared with GnRH antagonist MDP without OCP pretreatment and GnRH agonist low-dose long protocol (LP).
METHODS
A total of 120 poor responders were randomized into three groups according to controlled ovarian stimulation (COS) options; GnRH antagonist MDP after OCP pretreatment (group 1), GnRH antagonist MDP without OCP pretreatment (group 2) or GnRH agonist luteal low-dose LP without OCP pretreatment (group 3). Patients allocated in group 1 were pretreated with OCP for 21days in the cycle preceding COS, and ovarian stimulation using recombinant human FSH (rhFSH) was started 5 days after discontinuation of OCP.
RESULTS
There were no differences in patients' characteristics among three groups. Total dose and days of rhFSH used for COS were significantly higher in group 3 than in group 1 or 2. The numbers of mature oocytes, fertilized oocytes and grade I, II embryos were significantly lower in group 2 than in group 1 or 3. There were no significant differences in the clinical pregnancy rate and implantation rate among three groups.
CONCLUSION
GnRH antagonist MDP with OCP pretreatment is at least as effective as GnRH agonist low-dose LP in poor responders and can benefit the poor responders by reducing the amount and duration of FSH required for follicular maturation.
| 1significant effect
|
5,013,640 | 27,599,544 |
BACKGROUND
We hypothesized that pretreatment serum levels of insulin and other serum markers would predict Progression-free survival (PFS), defined as time to castration-resistant progression or death, in metastatic androgen-dependent prostate cancer (mADPC).
METHODS
Serum samples from treatment-naïve men participating in a randomized phase 3 trial of ADT +/- chemotherapy were retrospectively analyzed using multiplex assays for insulin and multiple other soluble factors. Cox proportional hazards regression models were used to identify associations between individual factor levels and PFS.
RESULTS
Sixty six patients were evaluable (median age = 72 years; median prostate surface antigen [PSA] = 31.5 ng/mL; Caucasian = 86 %; Gleason score ≥8 = 77 %). In the univariable analysis, higher insulin (HR = 0.81 [0.67, 0.98] p = 0.03) and C-peptide (HR = 0.62 [0.39, 1.00]; p = 0.05) levels were associated with a longer PFS, while higher Hepatocyte Growth Factor (HGF; HR = 1.63 [1.06, 2.51] p = 0.03) and Osteopontin (OPN; HR = 1.56 [1.13, 2.15]; p = 0.01) levels were associated with a shorter PFS. In multivariable analysis, insulin below 2.1 (ln scale; HR = 2.55 [1.24, 5.23]; p = 0.011) and HGF above 8.9 (ln scale; HR = 2.67 [1.08, 3.70]; p = 0.027) levels were associated with longer PFS, while adjusted by OPN, C-peptide, trial therapy and metastatic volume. Four distinct risk groups were identified by counting the number of risk factors (RF) including low insulin, high HGF, high OPN levels, and low C-peptide levels (0, 1, 2, and 3). Median PFS was 9.8, 2.0, 1.6, and 0.7 years for each, respectively (p < 0.001).
CONCLUSION
Pretreatment serum insulin, HGF, OPN, and C-peptide levels can predict PFS in men with mADPC treated with ADT. Risk groups based on these factors are superior predictors of PFS than each marker alone.
| 1significant effect
|
270,049 | 14,531,932 |
BACKGROUND
For older adults, hospitalization frequently results in deterioration of mobility and function. Nevertheless, there are little data about how older adults exercise in the hospital and definitive studies are not yet available to determine what type of physical activity will prevent hospital related decline. Strengthening exercise may prevent deconditioning and Pilates exercise, which focuses on proper body mechanics and posture, may promote safety.
METHODS
A hospital-based resistance exercise program, which incorporates principles of resistance training and Pilates exercise, was developed and administered to intervention subjects to determine whether acutely-ill older patients can perform resistance exercise while in the hospital. Exercises were designed to be reproducible and easily performed in bed. The primary outcome measures were adherence and participation.
RESULTS
Thirty-nine ill patients, recently admitted to an acute care hospital, who were over age 70 [mean age of 82.0 (SD= 7.3)] and ambulatory prior to admission, were randomized to the resistance exercise group (19) or passive range of motion (ROM) group (20). For the resistance exercise group, participation was 71% (p = 0.004) and adherence was 63% (p = 0.020). Participation and adherence for ROM exercises was 96% and 95%, respectively.
CONCLUSION
Using a standardized and simple exercise regimen, selected, ill, older adults in the hospital are able to comply with resistance exercise. Further studies are needed to determine if resistance exercise can prevent or treat hospital-related deterioration in mobility and function.
| 1significant effect
|
4,916,104 | 27,390,634 |
OBJECTIVE
Exergaming has been introduced in safe and beneficial intervention for the elderly. However, no study has examined exergaming-based interventions for the elderly that last several years. Therefore, we investigated the effectiveness and safety of a 12-week intervention using step training with exergaming for the elderly (12-week study). Moreover, we conducted an exergaming-based intervention for 3 years (3-year study).
MATERIALS AND METHODS
12-week study: Forty-two elderly persons participated in this study. Using an in-house developed exergaming protocol, a step training was performed for 15 min/session twice a week for 12 weeks. We investigated post-intervention changes in motor functions, successful step-rate, the intensity of exercise, which was evaluated using Borg scale (Rating of Perceived Exertion). 3-year study: An intervention using exergaming was conducted for 12 weeks by 20 elderly participants. Two courses/year of exercise were performed at 3-month intervals. This was continued for 3 years. The exercise continuation rate, its influence on motor functions were investigated.
RESULTS
12-week study: Lower-limb muscle strength, balancing capacity, and whole body reaction time significantly improved in the exercise group. The mean score on Borg scale was 12 ± 2 on the first day of the step exercise and 9 ± 2 on the final day. 3-year study: Exercise was continued in 16 out of the 20 subjects. The Timed Up and Go Test, duration of one-footed standing, and quadriceps strength significantly improved.
CONCLUSION
The results of the present study showed that exergaming provided an appropriate exercise intensity for the elderly and safely improved motor functions. The exercise continuation rate in the 3-year study was high. Improvements in motor functions may contribute to the prevention of falls.
| 1significant effect
|
4,065,280 | 24,831,048 |
INTRODUCTION
The purpose of this study was to determine the safety, tolerability and effectiveness of daily administration of an orally administered pantothenic acid-based dietary supplement in men and women with facial acne lesions.
METHODS
A randomized, double-blind, placebo-controlled study of adults previously diagnosed with mild to moderate acne vulgaris was performed. Subjects were randomized to the study agent, a pantothenic acid-based dietary supplement, or a placebo for 12 weeks (endpoint). The primary outcome of the study was the difference in total lesion count between the study agent group versus the placebo group from baseline to endpoint. Secondary measurements included differences in mean non-inflammatory and inflammatory lesions, Investigators Global Assessment and Dermatology Life Quality Index (DLQI) scores between the two groups. Investigator assessment of overall improvement and skin photographs were also taken. Safety and tolerability endpoints were the assessment of adverse events and measurement of serum complete blood count and hepatic function.
RESULTS
Forty-eight subjects were enrolled and 41 were evaluable. There was a significant mean reduction in total lesion count in the pantothenic acid group versus placebo at week 12 (P = 0.0197). Mean reduction in inflammatory lesions was also significantly reduced and DLQI scores were significantly lower at week 12 in the pantothenic acid group versus placebo. The study agent was safe and well tolerated.
CONCLUSIONS
The results from this study indicate that the administration of a pantothenic acid-based dietary supplement in healthy adults with facial acne lesions is safe, well tolerated and reduced total facial lesion count versus placebo after 12 weeks of administration. Secondary analysis shows that the study agent significantly reduced area-specific and inflammatory blemishes. Further randomized, placebo-controlled trials are warranted.
| 1significant effect
|
3,821,116 | 24,223,341 |
BACKGROUND
Postoperative pain of dacryocystorhinostomy (DCA) surgery is one of the serious issues to be considered. Administrating opioids to relieve postoperative pain and facing their increasing side effects in eye surgeries, make the use of non-opioid drugs inevitable.
OBJECTIVES
The present study examined the efficacy of pregabalin in alleviating the postoperative pain of DCA surgery.
PATIENTS AND METHODS
The present study has been carried out as a double-blind, randomized clinical trial on the patient candidates for DCR. The patients were randomly divided in to two groups of pregabalin and placebo. Patients in pregabalin group received 300 mg of pregabalin, an hour before the operation in the morning of the surgery. Pain intensity on visual analog scale (VAS) was recorded until 24 hours after the operation; also the rate of administrated opioids and nausea/vomiting frequency were recorded during the first 24-hour period after the operation and the resultsof the two groups were compared.
RESULTS
Postoperative pain intensity in the pregabalin group at the time of recovery was significantly lower than that of the placebo group (P = 0.001) until 24 hours after the surgery. In the pregabalin group 17.5% of the patients received opioids while in the placebo group the figure was 52.5% (P = 0.001). Nausea frequency was also higher in the placebo group than the pregabalin group (P = 0.003).
CONCLUSIONS
A single 300 mg dose of pregabalin, an hour before DCA can effectively reduce pain intensity and also reduce opioid dose and nausea/vomiting.
| 1significant effect
|
3,327,628 | 22,397,624 |
BACKGROUND
Achieving a high response rate in a physician survey is challenging. Monetary incentives increase response rates but obviously add cost to a survey project. We wondered whether an offer of a free continuing medical education (CME) activity would be effective in improving survey response rate.
RESULTS
As part of a survey of a national sample of physicians, we randomized half to an offer for a free on-line CME activity upon completion of a web-based survey and the other half to no such offer. We compared response rates between the groups. A total of 1214 out of 8477 potentially eligible physicians responded to our survey, for an overall response rate of 14.3%. The response rate among the control group (no offer of CME credit) was 16.6%, while among those offered the CME opportunity, the response rate was 12.0% (p < 0.0001).
CONCLUSIONS
An offer for a free on-line CME activity did not improve physician survey response rate. On the contrary, the offer for a free CME activity actually appeared to worsen the response rate.
| 1significant effect
|
5,427,603 | 28,499,363 |
BACKGROUND
Osteoarthritis of the first metatarsophalangeal joint (1st MTPJ OA) is a common and disabling condition commonly managed with footwear and orthotic interventions. The objective of this study was to identify factors associated with a successful treatment response in people with 1st MTPJ OA provided with prefabricated orthoses or rocker-sole footwear as part of a randomised clinical trial.
METHODS
People with 1st MTPJ OA (n = 88) who participated in a randomised trial were allocated to receive prefabricated foot orthoses (n = 47) or rocker-sole footwear (n = 41) and completed a baseline questionnaire including information on demographics, anthropometrics, general health, pain characteristics (including the Foot Health Status Questionnaire [FHSQ] and Foot Function Index [FFI]) and perceptions of the interventions, and a clinical assessment of foot posture, range of motion, radiographic severity and in-shoe plantar pressures. Adherence was documented using diaries. At 12 weeks, participants documented their perception of improvement on a 15-point scale. Those reporting at least moderate improvement on this scale were classified as 'responders'.
RESULTS
There were 29 responders (62%) in the orthoses group and 16 responders (39%) in the rocker-sole group. In the orthoses group, responders had greater baseline pain severity while walking, a higher FFI difficulty score, and wore their orthoses more frequently. In the rocker-sole group, responders had a higher FFI stiffness score and greater radiographic severity. However, the accuracy of these variables in identifying responders in each group was modest (62 and 53%, respectively).
CONCLUSION
The response to prefabricated orthoses or rocker-sole footwear in people with 1st MTPJ OA is related to measures of increased pain and disease severity. However, the overall classification accuracy associated with these factors is not sufficient for identifying individuals who are most likely to benefit from these interventions.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry: ACTRN12613001245785.
| 0no significant effect
|
3,411,720 | 22,870,238 |
BACKGROUND
The efficacy of preventive zinc supplementation against diarrhea and respiratory illness may depend on simultaneous supplementation with other micronutrients. We aimed to assess the effect of supplementation with zinc and multiple micronutrients on diarrhea and other causes of non-malarial morbidity.
METHODS AND FINDINGS
Rural Tanzanian children (n = 612) aged 6-60 months and with height-for-age z-score < -1.5 SD were randomized to daily supplementation with zinc (10 mg) alone, multi-nutrients without zinc, multi-nutrients with zinc, or placebo. Children were followed for an average of 45 weeks. During follow-up, we recorded morbidity episodes. We found no evidence that concurrent supplementation with multi-nutrients influenced the magnitude of the effect of zinc on rates of diarrhea, respiratory illness, fever without localizing signs, or other illness (guardian-reported illness with symptoms involving skin, ears, eyes and abscesses, but excluding trauma or burns). Zinc supplementation reduced the hazard rate of diarrhea by 24% (4%-40%). By contrast, multi-nutrients seemed to increase this rate (HR; 95% CI: 1.19; 0.94-1.50), particularly in children with asymptomatic Giardia infection at baseline (2.03; 1.24-3.32). Zinc also protected against episodes of fever without localizing signs (0.75; 0.57-0.96), but we found no evidence that it reduced the overall number of clinic visits.
CONCLUSIONS
We found no evidence that the efficacy of zinc supplements in reducing diarrhea rates is enhanced by concurrent supplementation with other micronutrients. By reducing rates of fever without localizing signs, supplementation with zinc may reduce inappropriate drug use with anti-malarial medications and antibiotics.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00623857.
| 0no significant effect
|
3,751,685 | 23,497,404 |
BACKGROUND
Frailty is a well known and accepted term to clinicians working with older people. The study aim was to determine whether an intervention could reduce frailty and improve mobility.
METHODS
We conducted a single center, randomized, controlled trial among older people who were frail in Sydney, Australia. One group received an intervention targeting the identified characteristics of frailty, whereas the comparison group received the usual health care and support services. Outcomes were assessed by raters masked to treatment allocation at 3 and 12 months after study entry. The primary outcomes were frailty as assessed by the Cardiovascular Health Study criteria, and mobility as assessed by the Short Physical Performance Battery. Secondary outcome measures included disability, depressive symptoms and health-related quality of life.
RESULTS
A total of 216 participants (90%) completed the study. Overall, 68% of participants were women and the mean age was 83.3 years (standard deviation, 5.9). In the intention-to-treat analysis, the between-group difference in frailty was 14.7% at 12 months (95% confidence interval: 2.4%, 27.0%; P = 0.02). The score on the Short Physical Performance Battery, in which higher scores indicate better physical status, was stable in the intervention group and had declined in the control group; with the mean difference between groups being 1.44 (95% confidence interval, 0.80, 2.07; P <0.001) at 12 months. There were no major differences between the groups with respect to secondary outcomes. The few adverse events that occurred were exercise-associated musculoskeletal symptoms.
CONCLUSIONS
Frailty and mobility disability can be successfully treated using an interdisciplinary multifaceted treatment program.
TRIAL REGISTRATION
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12608000250336.
| 1significant effect
|
4,731,919 | 26,822,537 |
BACKGROUND
Periodontal disease is a significant public health issue worldwide. Motivational techniques in combination with financial incentives are shown to lead to effective behavior change. The current study sought to examine whether a brief oral health promotion program (self-management cues that were based on self-efficacy and self-regulatory skills) in combination with an incentive (free dental treatment) would make a difference in the adoption of regular dental flossing in a population of Indian periodontal disease outpatients.
METHODS
One hundred and twelve participants (n = 55 oral health promotion intervention group; n = 57 control group) were assigned to the intervention (self-management cues + incentive) or control groups, and follow-up assessments were performed three weeks later. Flossing frequency, behavioral intentions, and perceived self-efficacy served as dependent variables. Data were analyzed with mixed models, ANCOVAs, and path analyses.
RESULTS
The intervention yielded effects on flossing frequency (p < 0.01) and flossing intentions (p < 0.01) at follow-up. Women developed stronger intentions than men. Moreover, by path analysis a sequential mediation chain was found that demonstrated an indirect effect of the intervention on flossing via self-efficacy and intentions: the intervention predicted changes in self-efficacy which, in turn, were associated with changes in intentions, predicting flossing frequency at follow up, while controlling for baseline behavior, gender, and age.
CONCLUSIONS
Combining incentives with minimal self-management cues has been found effective in improving interdental cleaning intentions and habits in periodontal disease patients, and the facilitating role of dental self-efficacy has been demonstrated.
| 1significant effect
|
4,608,626 | 26,483,829 |
BACKGROUND/AIMS
To investigate the effect of singing training on the cognitive function in Alzheimer's disease (AD) patients.
METHODS
Ten AD patients (mean age 78.1 years) participated in music therapy using singing training once a week for 6 months (music therapy group). Each session was performed with professional musicians using karaoke and a unique voice training method (the YUBA Method). Before and after the intervention period, each patient was assessed by neuropsychological batteries, and functional magnetic resonance imaging (fMRI) was performed while the patients sang familiar songs with a karaoke device. As the control group, another 10 AD patients were recruited (mean age 77.0 years), and neuropsychological assessments were performed twice with an interval of 6 months.
RESULTS
In the music therapy group, the time for completion of the Japanese Raven's Colored Progressive Matrices was significantly reduced (p = 0.026), and the results obtained from interviewing the patients' caregivers revealed a significant decrease in the Neuropsychiatric Inventory score (p = 0.042) and a prolongation of the patients' sleep time (p = 0.039). The fMRI study revealed increased activity in the right angular gyrus and the left lingual gyrus in the before-minus-after subtraction analysis of the music therapy intervention.
CONCLUSION
Music therapy intervention using singing training may be useful for dementia patients by improving the neural efficacy of cognitive processing.
| 1significant effect
|
2,876,942 | 20,532,105 |
BACKGROUND AND OBJECTIVES
The use of sevoflurane in pediatric anesthesia, which could enable a more rapid emergence and recovery, is complicated by the frequent occurrence of post-anesthesia agitation. This study aims to test the efficacy of adding a low dose of ketamine orally, as a supplement to the midazolam-based oral premedication for reducing sevoflurane-related emergence agitation.
MATERIALS AND METHODS
Ninety-two preschool children, aged between two and six years, with an American Society of Anesthesiologists physical status I or II, scheduled for elective dental filling and extractions under general anesthesia were included. The patients were allocated into two groups: Group M (46 patients) received oral midazolam 0.5 mg/kg, mixed with ibuprofen 10 mg/kg, while group KM (46 patients) received a similar premedication mixture, in addition to ketamine 2 mg/kg. The acceptance of the drug mixture, the onset of action, and the occurrence of vomiting were monitored over the next 30 minutes. Induction of anesthesia was carried out using sevoflurane 8 Vol% in 100% oxygen via face mask. Anesthesia was maintained with sevoflurane 1.5-2 Vol% in an oxygen-nitrous oxide mixture. After extubation, the standard scoring scale was used for assessing the quality of emergence. Agitation parameters were measured using a five-point scale. Agitated children were managed by giving intravenous increments of fentanyl 1 mug/ kg. The time of hospital discharge allowance was recorded.
RESULTS
Drug palatability, vomiting, and onset of action of premedication; showed no significant differences between both groups. Time of eye opening after discontinuation of sevoflurane showed no significant differences between both groups. Postoperative agitation score and rescue fentanyl consumption were higher in group M than in group KM on admission to the PACU (P < 0.01). The time of hospital discharge allowance in group M was longer than in group KM (P < 0.05).
CONCLUSION
Adding a low dose of oral ketamine to midazolam-based oral premedication in preschool children undergoing dental surgery reduced sevoflurane-related emergence agitation without delaying discharge.
| 0no significant effect
|
5,133,227 | 27,924,196 |
BACKGROUND
A nasogastric tube (NGT) is commonly inserted into patients undergoing abdominal surgery to decompress the stomach during or after surgery. However, for anatomic reasons, the insertion of NGTs into anesthetized and intubated patients may be challenging. We hypothesized that the use of a tube exchanger for NGT insertion could increase the success rate and reduce complications.
METHODS
One hundred adult patients, aged 20-70 years, who were scheduled for gastrointestinal surgeries with general anesthesia and NGT insertion were enrolled in our study. The patients were randomly allocated to the tube-exchanger group or the control group. The number of attempts, the time required for successful NGT insertion, and the complications were noted for each patient.
RESULTS
In the tube-exchanger group, the success rate of NGT insertion on the first attempt was 92%, which is significantly higher than 68%, the rate in the control group (P = 0.007). The time required for successful NGT insertion in the tube-exchanger group was 18.5 ± 8.2 seconds, which is significantly shorter than the control group, 75.1 ± 9.8 seconds (P < 0.001). Complications such as laryngeal bleeding and the kinking and knotting of the NGT occurred less often in the tube-exchanger group.
CONCLUSIONS
There were many advantages in using a tube-exchanger as a guide to inserting NGTs in anesthetized and intubated patients. Compared to the conventional technique, the use of a tube-exchanger resulted in a higher the success rate of insertion on the first attempt, a shorter procedure time, and fewer complications.
| 1significant effect
|
5,104,394 | 27,832,121 |
BACKGROUND AND OBJECTIVES
A sizeable proportion of patients experiencing binge eating do not respond to cognitive behavioral therapy (CBT). We present the sequential binge (SB), a new behavioral intervention that complements CBT, and preliminary results of its effects. SB breaks up the binge into repeated identical sequences of eating separated by incremental pauses. This pattern of ingestion aims at facilitating boredom toward the ingested foods and at turning cognitive control away from binge food restriction. SB is hypothesized to reduce food intake during the binge and the number of daily binges.
METHODS
Prospective pilot study. Fifteen binging patients with previous unsuccessful intensive CBT were given SB as an adjunct to their treatment and were followed up for 16 weeks from admission. All patients were reassessed 47 weeks on average after discharge.
RESULTS
SB was associated with a 44% relative reduction in the planned food intake (p<0.001), a longer consecutive binge refractory period compared to regular binges (median: 48 hours versus 4 hours, p = 0.002) and an average relative reduction by 26% of binge number the day after each SB (p = 0.004). 47% of patients reached binge abstinence for four consecutive weeks 16 weeks after the first SB.
CONCLUSION
This case series shows promising evidence for the use of SB in patients with refractory binge eating. Further evaluation in a prospective randomized controlled trial would be justified.
| 1significant effect
|
3,337,377 | 22,558,497 |
BACKGROUND
Epidrum® is a recently developed, air operated, loss of resistance (LOR) device for identifying the epidural space. We investigated the usefulness of Epidrum® by comparing it with the conventional LOR technique for identifying the epidural space.
METHODS
One hundred eight American Society of Anesthesiologists (ASA) physical status I or II patients between the ages of 17 and 68 years old and who were scheduled for elective surgery under combined spinal-epidural anesthesia were enrolled in this study. The patients were randomized into two groups: one group received epidural anesthesia by the conventional LOR technique (C group) and the second group received epidural anesthesia using Epidrum® (ED group). While performing epidural anesthesia, the values of variables were recorded, including the number of failures, more than 2 attempts, the incidence of dural puncture, the time needed to locate the epidural space, the distance from the skin to the epidural space and ease of performance, and the satisfaction scores.
RESULTS
The ED group showed a lower failure rate, fewer cases of more than 2 attempts, a lesser time to identify the epidural space, and better ease and satisfaction scores of procedure than the C group, with statistical significance.
CONCLUSIONS
Using Epidrum® compared to the conventional LOR technique is an easy, rapid, and reliable method for identifying the epidural space.
| 1significant effect
|
4,355,974 | 25,885,418 |
BACKGROUND
Asthma is the most common chronic condition of childhood and disproportionately affects inner-city minority children. Low rates of asthma preventer medication adherence is a major contributor to poor asthma control in these patients. Web-based methods have potential to improve patient knowledge and medication adherence by providing interactive patient education, monitoring of symptoms and medication use, and by facilitation of communication and teamwork among patients and health care providers. Few studies have evaluated web-based asthma support environments using all of these potentially beneficial interventions. The multidimensional website created for this study, BostonBreathes, was designed to intervene on multiple levels, and was evaluated in a pilot trial.
METHODS
An interactive, engaging website for children with asthma was developed to promote adherence to asthma medications, provide a platform for teamwork between caregivers and patients, and to provide primary care providers with up-to-date symptom information and data on medication use. Fifty-eight (58) children primarily from inner city Boston with persistent-level asthma were randomised to either usual care or use of BostonBreathes. Subjects completed asthma education activities, and reported their symptoms and medication use. Primary care providers used a separate interface to monitor their patients' website use, their reported symptoms and medication use, and were able to communicate online via a discussion board with their patients and with an asthma specialist.
RESULTS
After 6-months, reported wheezing improved significantly in both intervention and control groups, and there were significant improvements in the intervention group only in night-time awakening and parental loss of sleep, but there were no significant differences between intervention and control groups in these measures. Emergency room or acute visits to a physician for asthma did not significantly change in either group. Among the subgroup of subjects with low controller medication adherence at baseline, adherence improved significantly only in the intervention group. Knowledge of the purpose of controller medicine increased significantly in the intervention group, a statistically significant improvement over the control group.
CONCLUSIONS
This pilot study suggests that a multidimensional web-based educational, monitoring, and communication platform may have positive influences on pediatric patients' asthma-related knowledge and use of asthma preventer medications.
| 0no significant effect
|
5,506,697 | 28,706,563 |
BACKGROUND
We examined the efficacy of olanzapine/fluoxetine combination (OFC) in improving health-related quality of life (QoL) in the treatment of bipolar depression in children and adolescents.
METHODS
Patients aged 10-17 years with bipolar I disorder, depressed episode, baseline children's depression rating scale-revised (CDRS-R) total score ≥40, Young Mania Rating Scale (YMRS) total score ≤15, and YMRS-item 1 ≤ 2 were randomized to OFC (6/25-12/50 mg/day olanzapine/fluoxetine; n = 170) or placebo (n = 85) for up to 8 weeks of double-blind treatment. Patients and parents completed the revised KINDL questionnaire for measuring health-related QoL in children and adolescents (KINDL-R) at baseline and endpoint. The mean change in CDRS-R total and item scores were used to compare improvement in symptomatology in patients taking OFC and placebo. Tests were 2-sided using a Type I error cutoff of 0.05, and no adjustments for multiple comparisons were made.
RESULTS
Baseline QoL as measured by the KINDL-R was substantially impaired relative to published norms for a healthy school-based sample. OFC-treated patients demonstrated an improvement over placebo at endpoint with respect to mean change from baseline in the patient-rated KINDL-R Self-esteem subscale score ( p = 0.028), and in the parent KINDL-R ratings of emotional well-being ( p = 0.020), Self-esteem ( p = 0.030), and Family ( p = 0.006). At endpoint, OFC-treated patients still had a lower QoL compared to the normative population. OFC showed significant improvement ( p ≤ 0.05) versus placebo on the CDRS-R total score and on 7 of the 17 CDRS-R items.
CONCLUSIONS
Patients aged 10-17 years with an acute episode of bipolar depression and their parents reported greater improvements (parents noticed improvements in more areas than did their offspring) on some aspects of QoL when treated with OFC compared with placebo. However, after 8 weeks of treatment, KINDL-R endpoint scores remained lower than those of the, presumably healthy, control population. Clinical trial registration information A Study for Assessing Treatment of Patients Ages 10-17 with Bipolar Depression; http://www.clinicaltrials.gov; NCT00844857.
| 1significant effect
|
3,487,501 | 23,130,032 |
INTRODUCTION
Root canal obturation seals the root canal system to prevent re-entry and/or growth of microorganisms. The provision of an appropriate restoration to coronally seal the access cavity affects the success of endodontic treatment. The purpose of this study was to evaluate the coronal microbial leakage in root canals that were either filled by lateral compaction, GuttaFlow or warm vertical compaction.
MATERIALS AND METHODS
In this ex vivo study, 80 single-rooted human extracted teeth were randomly divided into three experimental groups (n=20) and two positive and negative control groups (n=10). The teeth in experimental groups were obturated with cold lateral compaction, GuttaFlow system or warm vertical compaction techniques. After sterilization of the whole system with gamma-ray, saliva leakage was tested using a split-chamber model. Specimens were monitored every 24 hours for 30 days. The data were analyzed using log-rank and Kaplan-Meier survival analysis tests.
RESULTS
There were no significant differences in impeding saliva leakage between the three experimental groups (P>0.05).
CONCLUSION
Under the conditions of this ex vivo study, it can be concluded that the sealing ability of cold lateral compaction, warm vertical compaction and GuttaFlow system was comparable.
| 0no significant effect
|
4,598,910 | 26,457,101 |
BACKGROUND
Chronic obstructive pulmonary disease (COPD) is currently the fourth cause of mortality worldwide. Patients with COPD experience periods of dyspnea, fatigue, and disability, which impact on their life. The objective of this study was to investigate the effect of short-term inspiratory muscle training on exercise capacity, exertional dyspnea, and pulmonary lung function.
MATERIALS AND METHODS
A randomized, controlled trial was performed. Thirty patients (27 males, 3 females) with mild to very severe COPD were randomly assigned to a training group (group T) or to a control group (group C). Patients in group T received training for 8 weeks (15 min/day for 6 days/week) with flow-volumetric inspiratory exerciser named (Respivol). Each patient was assessed before and after 8 weeks of training for the following clinical parameters: exercise capacity by 6-min walking test (6MWT), exertional dyspnea by Borg scale, and pulmonary lung function by spirometry. Patients used training together with medical treatment. The data were analyzed using paired t-test and independent t-test.
RESULTS
Results showed statistically significant increase in 6MWT at the end of the training from 445.6 ± 22.99 to 491.06 ± 17.67 meters? (P < 0.001) and statistically significant decrease in dyspnea from 3.76 ± 0.64 to 1.13 ± 0.36 (P = 0.0001) in the training group but not in the control group. The values for exercise capacity and dyspnea improved after 8 weeks in group T in comparison with group C (P = 0.001 and P = 0.0001, respectively). No changes were observed in any measure of pulmonary function in both groups.
CONCLUSIONS
Short-term inspiratory muscle training has beneficial effects on exercise capacity and exertional dyspnea in COPD patients.
| 1significant effect
|
2,678,276 | 19,386,096 |
BACKGROUND
Phase II studies have shown that the combination of capecitabine and irinotecan (the XELIRI regimen) is active in metastatic colorectal cancer (MCRC). There are, however, no data about the use of the XELIRI regimen in the neoadjuvant treatment.
METHODS
Patients with unresectable liver-only metastases of MCRC with < or = 75 years of age were randomised to either the XELIRI (irinotecan 250 mg/m(2) given on day one and capecitabine 1000 mg/m(2) twice daily from day 2-15, every 21 days) or the FOLFIRI arm (irinotecan 180 mg/m(2), 5-FU 400 mg/m(2), LV 200 mg/m(2), 5-FU 2400 mg/m(2) (46-h infusion)--all given on day one, every 14 days). Primary end points were objective response rate (ORR) and rate of radical (R0) surgical resection. Secondary end points were progression-free survival (PFS), overall survival (OS) and safety.
RESULTS
Altogether 87 patients were enrolled (41 pts in the XELIRI and 46 pts in the FOLFIRI arm). The median age was 63 years (63 years in the XELIRI and 62 years in the FOLFIRI arm) (p = 0.33). ORR was 49% in the XELIRI and 48% in the FOLFIRI arm (p = 0.76). The rate of radical R0 resection was 24% in both arms of patients. At the end of treatment, 37% of patients in the XELIRI and 26% of patients in the FOLFIRI arm were without evidence of the disease (CR+R0 resection) (p = 0.56). There were no statistical differences in grade 3 or 4 adverse events between both arms: diarrhoea 7% vs. 6%, neutropenia 5% vs. 13%, ischemic stroke 0 vs. 2%, acute coronary syndrome 2% vs. 4%, respectively. At the median follow up of 17 (range 1-39) months, the median PFS was 10.3 months in the XELIRI and 9.3 months in the FOLFIRI arm (p = 0.78), the median OS was 30.7 months in the XELIRI arm and 16.6 months in the FOLFIRI arm (p = 0.16).
CONCLUSION
The XELIRI regimen showed similar ORR as the FOLFIRI regimen in the neoadjuvant treatment of patients with MCRC. In addition, the XELIRI regimen showed similar PFS and OS with acceptable toxicity compared to the FOLFIRI regimen.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN19912492.
| 0no significant effect
|
3,425,748 | 23,012,033 |
OBJECTIVE
To measure changes in the attitude of Primary Health Care (PHC) physicians towards mental illnesses after a short-term training course. In addition, to ascertain if this change would persist 6 months after the training course.
METHOD
This is an intervention type study. Out of 296 PHC physicians working in Eastern Saudi Arabia, 191 were randomly selected and divided randomly into two groups. The Study groups were tested for pre and post exposure (immediate and 6months later), to the psychiatric training course. The Control group was not involved in the intervention. The course was run over a 4-day period in June 1999. A 26-item self-administered questionnaire to assess the PHC physicians' attitudes was used.
RESULTS
The study group consisted of 45 trainees, 24 (53%) of whom were men. The control group, 121 out of 166 physicians, responded to the questionnaire, with an 83% response rate, men forming 49%. The data analysis indicated a significant improvement in the PHC physicians' attitude after the course (P<0.0001). Six months later, as compared with their immediate post-test, the positive attitudes persisted within the study group (p-value=0.274). Multiple regressions indicated that the duration of undergraduate psychiatric training was the only contributor factor.
CONCLUSION
This training course resulted in a positive change in the trainees' attitudes. Besides, it showed that the undergraduate psychiatric training had a favourable effect on the PHC physicians' attitude. Therefore, there should be frequent mental health training programs for PHC physicians. Moreover, physicians who spent longer period in undergraduate psychiatric training should be given the priority to work in PHC settings.
| 1significant effect
|
3,511,948 | 23,225,931 |
BACKGROUND
Epidural analgesia with opioid provides good control of postoperative pain in cesarean section, thereby improving the mother's ability to mobilize and interact with her newborn infant.
AIM
The aim of this study is to evaluate and compare the analgesic actions and side effects of epidural analgesia with sufentanil, morphine or combination of the two after cesarean section.
MATERIALS AND METHODS
60 women undergoing elective cesarean section were allocated into three groups of 20 each in a randomized blinded fashion. Epidural analgesia was administered with sufentanil 50 mcg in Group S; morphine 4 mg in Group M; and, a combination of sufentanil 25 mcg and morphine 2 mg was used in Group SM. Analgesic efficacy in terms of onset of action and duration of analgesia was assessed by using the Visual Analog Scale (0 to 10 cm) for 24 hours. Number of opioid doses needed in 24 hours was noted. Side effects like respiratory depression /excessive sedation, pruritus and nausea were recorded.
RESULTS
Onset of action were at 7.6 ± 1.5 minutes in group S, 67.6 ± 1.5 minutes in group M and 12.2 ± 2.6 minutes in group SM. Duration of analgesia was longer in group M 17.5 ± 1.9 hours and SM 13.8 ± 1.6 hours than in group S 5.2 ± 1.2 hours. More doses of analgesia were required in group S compared to group M and SM. Side effects were comparable in the three groups.
CONCLUSION
Epidural administration of a combination of sufentanil and morphine offered the advantage of faster onset of action and longer duration of analgesia as compared to the two drugs administered alone.
| 1significant effect
|
5,520,118 | 28,425,778 |
Background and aims Workaholism is a form of behavioral addiction that can lead to reduced life and job satisfaction, anxiety, depression, burnout, work-family conflict, and impaired productivity. Given the number of people affected, there is a need for more targeted workaholism treatments. Findings from previous case studies successfully utilizing second-generation mindfulness-based interventions (SG-MBIs) for treating behavioral addiction suggest that SG-MBIs may be suitable for treating workaholism. This study conducted a controlled trial to investigate the effects of an SG-MBI known as meditation awareness training (MAT) on workaholism. Methods Male and female adults suffering from workaholism (n = 73) were allocated to MAT or a waiting-list control group. Assessments were performed at pre-, post-, and 3-month follow-up phases. Results MAT participants demonstrated significant and sustained improvements over control-group participants in workaholism symptomatology, job satisfaction, work engagement, work duration, and psychological distress. Furthermore, compared to the control group, MAT participants demonstrated a significant reduction in hours spent working but without a decline in job performance. Discussion and conclusions MAT may be a suitable intervention for treating workaholism. Further controlled intervention studies investigating the effects of SG-MBIs on workaholism are warranted.
| 1significant effect
|
5,122,106 | 27,904,608 |
BACKGROUND
Obesity is a worldwide health problem which is associated with a lot of complications. One of these comorbidities is the metabolic syndrome that is in correlation with abdominal fat thickness and waist circumference. Various methods were used to reduce abdominal fat thickness such as liposuction. A noninvasive method is the topical agent. In this study, we investigated the effectiveness of Arnebia euchroma (AE) ointment on the abdominal fat thickness.
MATERIALS AND METHODS
This study was a double-blind clinical trial which was done at the endocrinology clinic in Khorshid Hospital, Isfahan, Iran, in 2014. After explaining the procedure and obtaining informed consent, the candidates were randomly divided into the case and control groups. The participants of the case and control groups applied AE ointment or placebo for 6 weeks on their abdominal area. Body mass index, waist and buttock circumference, and abdominal fat thickness were measured in both case and control groups at their first visit and then at the next 2, 4, and 6 weeks. We used t -test for comparing parametric variables between groups, paired t -test for changes from baseline to final, and repeated measure ANOVA for changes at different steps.
RESULTS
Sixty female candidates participated in this study (thirty in each group). Ten patients left the study and fifty participants finished the trial. At the end of the study, participants had a significant weight loss (2.96 ± 1.6 kg, P < 0.001) that was slightly more in the case group (3.15 ± 1.5 kg vs. 2.75 ± 1.7, P = 0.375). Abdominal circumference also decreased significantly in the participants (11.3 ± 6.7 cm, P < 0.001), but the changes were more significant in the case group (13.9 vs. 6.5 cm, P = 0.004). Similarly, abdominal fat thickness decreased significantly in the participants (2.3 ± 1.1 cm, P < 0.001), although changes were not significantly different between two groups (2.53 vs. 2.04 cm, P = 0.139).
CONCLUSION
Topical AE ointment can reduce the abdominal fat thickness as well as the waist circumference without causing any side effect.
| 0no significant effect
|
3,515,338 | 23,052,105 |
BACKGROUND
Mental health problems are common and are associated with increased disability and health care costs. Problem-Solving Treatment (PST) delivered to these patients by nurses in primary care might be efficient. The aim of this study was to evaluate the cost-effectiveness of PST by mental health nurses compared with usual care (UC) by the general practitioner for primary care patients with mental health problems.
METHODS
An economic evaluation from a societal perspective was performed alongside a randomized clinical trial. Patients with a positive General Health Questionnaire score (score ≥ 4) and who visited their general practitioner at least three times during the past 6 months were eligible. Outcome measures were improvement on the Hospital Anxiety and Depression Scale and QALYs based on the EQ-5D. Resource use was measured using a validated questionnaire. Missing cost and effect data were imputed using multiple imputation techniques. Bootstrapping was used to analyze costs and cost-effectiveness of PST compared with UC.
RESULTS
There were no statistically significant differences in clinical outcomes at 9 months. Mean total costs were €4795 in the PST group and €6857 in the UC group. Costs were not statistically significantly different between the two groups (95% CI -4698;359). The cost-effectiveness analysis showed that PST was cost-effective in comparison with UC. Sensitivity analyses confirmed these findings.
CONCLUSIONS
PST delivered by nurses seems cost-effective in comparison with UC. However, these results should be interpreted with caution, since the difference in total costs was mainly caused by 3 outliers with extremely high indirect costs in the UC group.
TRIAL REGISTRATION
Nederlands Trial Register ISRCTN51021015.
| 0no significant effect
|
5,598,124 | 28,932,498 |
BACKGROUND
Dissection of aorta is a rare, but fatal complication of aortic cannulation in cardiac surgery can be caused by the sudden rise in blood pressure and hemodynamic variations.
METHODS
In this study, 90 patients aged 18 years or older undergoing cardiac surgery were divided into two equal groups. Under similar conditions, trial group received 1.5 mg/kg of lidocaine for 90 s before cannulation and control group received normal saline. Hemodynamic parameters of patients including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), and central venous pressure before cannulation and 1, 3, and 5 min after cannulation were recorded in a form. Consumed nitroglycerin (TNG) rate was also measured and recorded.
RESULTS
In the lidocaine group, compared with the placebo group, mean SBP, DBP, and MAP significantly reduced after cannulation ( P < 0.05). During the follow-up period, mean HR ( P = 0.649) and TNG usage ( P = 0.527) were similar in two groups.
CONCLUSION
Intravenous lidocaine, 1.5 mg/kg, 90 s before cannulation leads to a reduction in SBP, DBP, and MAP, up to 5 min after cannulation, so it can decrease risk of aortic dissection.
| 0no significant effect
|
5,289,138 | 28,179,966 |
BACKGROUND
The aim of this study was to investigate the efficacy and safety of vildagliptin as an add-on therapy for patients with type 2 diabetes mellitus inadequately controlled with basal insulin.
METHODS
Twenty-four patients treated with basal insulin and oral anti-diabetes drugs were randomly allocated into two groups: the control group (did not receive any add-on drugs) and vildagliptin group (received vildagliptin 100 mg/day for 6 months). The primary outcome was changes in hemoglobin A1c (HbA1c) from baseline to end of study.
RESULTS
Treatment with vildagliptin significantly reduced HbA1c from 8.1±0.7% at baseline to 7.1±0.7% (P < 0.01), while there was no significant change of HbA1c in the control group. Vildagliptin group showed significant reduction of HbA1c compared with control group (-1.0±0.3% vs. 0.2±0.8%, P < 0.01). In addition, vildagliptin group showed a significant increase in 1,5-anhydroglucitol compared with the control group (4.5 ± 3.4 vs. 0.5 ± 4.1 μg/mL, P < 0.05). Mild hypoglycemia was reported in one patient of the vildagliptin group and two patients of the control group.
CONCLUSION
Vildagliptin improved glycemic control without increasing hypoglycemia in Japanese type 2 diabetes inadequately controlled with basal insulin treatment and other oral anti-diabetes drugs. This study was registered with UMIN (University Hospital Medical Information Network ID#000010849).
| 1significant effect
|
4,517,637 | 26,215,396 |
BACKGROUND
Infants undergoing cardiac surgery are at risk of a negative protein balance, due to increased proteolysis in response to surgery and the cardiopulmonary bypass circuit, and limited intake. The aim of the study was to quantify the effect on protein kinetics of a short-term high-protein (HP) diet in infants following cardiac surgery.
METHODS
In a prospective, double-blinded, randomized trial we compared the effects of a HP (5 g · kg(-1) · d(-1)) versus normal protein (NP, 2 g · kg(-1) · d(-1)) enteral diet on protein kinetics in children <24 months, on day 2 following surgical repair of congenital heart disease. Valine kinetics and fractional albumin synthesis rate (FSRalb) were measured with mass spectrometry using [1-(13)C]valine infusion. The Mann-Whitney U test was used to investigate differences between group medians. Additionally, the Hodges-Lehmann procedure was used to create a confidence interval with a point estimate of median differences between groups.
RESULTS
Twenty-eight children (median age 9 months, median weight 7 kg) participated in the study, of whom in only 20 subjects isotopic data could be used for final calculations. Due to underpowering of our study, we could not draw conclusions on the primary outcome parameters. We observed valine synthesis rate of 2.73 (range: 0.94 to 3.36) and 2.26 (1.85 to 2.73) μmol · kg(-1) · min(-1) in the HP and NP diet, respectively. The net valine balance was 0.54 (-0.73 to 1.75) and 0.24 (-0.20 to 0.63) μmol · kg(-1) · min(-1) in the HP and NP group. Between groups, there was no difference in FSRalb. We observed increased oxidation and BUN in the HP diet, compared to the NP diet, as a plausible explanation of the metabolic fate of surplus protein.
CONCLUSIONS
It is plausible that the surplus protein in the HP group has caused the increase of valine oxidation and ureagenesis, compared to the NP group. Because too few patients had completed the study, we were unable to draw conclusions on the effect of a HP diet on protein synthesis and balance. We present our results as new hypothesis generating data.
TRIAL REGISTRATION
Dutch Trial Register NTR2334.
| 0no significant effect
|
4,282,128 | 23,859,696 |
BACKGROUND AND AIMS
Bupropion was introduced for smoking cessation following a pivotal trial showing that it gave improved efficacy over the nicotine patch and also suggesting combination treatment was beneficial. We tested in clinical practice for an effectiveness difference between bupropion and nicotine replacement therapy (NRT), whether the combination improves effectiveness and whether either treatment might be more beneficial for certain subgroups of smokers.
DESIGN
Open-label randomized controlled trial with 6-month follow-up.
SETTING
Four UK National Health Service (NHS) smoking cessation clinics.
PARTICIPANTS
Smokers (n = 1071) received seven weekly behavioural support sessions and were randomized to an NRT product of their choice (n = 418), bupropion (n = 409) or NRT plus bupropion (n = 244).
MEASURES
The primary outcome was self-reported cessation over 6 months, with biochemical verification at 1 and 6 months. Also measured were baseline demographics, health history, smoking characteristics and unwanted events during treatment.
FINDINGS
Abstinence rates for bupropion (27.9%) and NRT (24.2%) were not significantly different (odds ratio = 1.21, 95% confidence interval = 0.883-1.67), and the combination rate (24.2%) was similar to that for either treatment alone. There was some evidence that the relative effectiveness of bupropion and NRT differed according to depression (χ(2) = 2.86, P = 0.091), with bupropion appearing more beneficial than NRT in those with a history of depression (29.8 versus 18.5%). Several unwanted symptoms were more common with bupropion.
CONCLUSION
There is no difference in smoking cessation effectiveness among bupropion, nicotine replacement therapy and their combination when used with behavioural support in clinical practice. There is some evidence that bupropion is more beneficial than nicotine replacement therapy for smokers with a history of depression.
| 0no significant effect
|
4,222,010 | 25,389,484 |
BACKGROUND
Headache is one of the most prevalent investigated complaints in the neurology clinics and is the most common pain-related complaint worldwide. Stress is a significant factor that causes and triggers headaches. Since healthcare practitioners experience a lot of stress in their careers, they are more prone to headaches.
OBJECTIVES
This study was designed to evaluate and compares the efficacy of neurofeedback behavioural therapy (NFB) and transcutaneous electrical nerve stimulation (TENS) in the treatment of primary headaches in healthcare providers.
PATIENTS AND METHODS
The current study was a clinical trial, performed in Teheran, IR Iran, with two experimental groups and a control group. Convenient sampling method was used to recruit patients. Independent variables were NFB and TENS and dependent variables were frequency, severity, and duration of headache. Blanchard headache diary was used for assessment. Hence, 45 healthcare providers with primary headache were selected and randomly allocated to one of the NFB, TENS, and control groups by block random assignment method. All three groups completed the headache diary during one week before and after the treatment period as pretest and posttests, respectively. The NFB group was treated in the period between pretest and posttest with fifteen 30-minute treatment sessions three times a week and the TENS group was treated with fifteen 20-minute daily sessions. The control group received none of these treatments.
RESULTS
The results from the analysis of covariance showed that treatment with NFB and TENS had caused significant decrease in the frequency, severity, and duration of headache in experimental groups. The results of the LSD post-hoc test indicated that there were significant differences in the frequency, severity, and duration of pain among experimental groups and the control group. Moreover, there were significant differences between pain frequencies in experimental groups.
CONCLUSIONS
According to the results and given the significant reductions in the frequency, severity, and duration of headaches, it seems that NFB and TENS might have an effective role in reducing primary headaches of healthcare providers. In addition, comparing the two methods, treatment with NFB was more effective in reducing headache frequency and severity.
| 1significant effect
|
4,223,972 | 25,400,683 |
BACKGROUND
Diabetes mellitus is considered as the most common metabolic disorder. The patients with diabetes are likely to be affected by mental distress, especially depression. Nurses should pay attention to the psychological needs of depressive patients by participating in an application of non-pharmacological treatment such as cognitive-behavioral therapy. This study aimed to assess the effect of cognitive-behavioral group therapy on depression in patients with diabetes.
MATERIALS AND METHODS
This randomized controlled trial was performed in 2010 in the diabetes clinics affiliated to Shiraz University of Medical Sciences, Shiraz, southern Iran. In this study, 60 eligible patients suffering from depression were randomly divided into two groups by convenience sampling method, using random block allocation. The experimental group was randomly subdivided into three groups of 10 each and received eight sessions of cognitive-behavioral group therapy. The level of depression was checked before as well as 2 weeks, 4 weeks, and 2 months after the intervention in both groups. Glycosylated hemoglobin (HbA1c) level was also checked before and 2 months after the intervention.
RESULTS
Both groups were demographically homogeneous with no statistically significant difference. The trend in depression scores before as well as 2 weeks, 4 weeks, and 2 months after the intervention was statistically significant in the experimental group (P ≤ 0.001), but not in the control group (P = 0.087). The results showed that HbA1c variation was statistically significant before and after the intervention in both groups (P ≤ 0.001). However, the mean variation of HbA1c was not statistically significant between the groups (P = 0.473).
CONCLUSIONS
Cognitive-behavioral group therapy was effective in reducing depression in patients with diabetes. Therefore, this method can be recommended for such patients.
| 0no significant effect
|
5,168,897 | 28,003,696 |
BACKGROUND AND AIMS
Awake flexible fibre-optic bronchoscope (FFS) is the standard method of intubation in difficult airway in oral cancer patients. We decided to evaluate GlideScope ® video laryngoscope (GL) for intubation as compared to the standard FFS for nasal intubation in such patients.
METHODS
After the ethical committee approval, we included 54 oropharyngeal cancer patients divided randomly into two equal groups: Group G and Group F. After pre-medication and pre-oxygenation, awake nasal intubation was performed using GL in Group G and FFS in Group F. In both groups, we compared intubation time in seconds (mean ± standard deviation) (primary outcome), success rate of the first intubation attempt, percentage of Cormack and Lehane glottic score and incidence of complications. We assumed that GL could be a suitable alternative for the standard FFS in nasal intubation of patients with oropharyngeal cancer. Success rate of the first attempt and Cormack and Lehane glottic score were compared using Chi-square test.
RESULTS
Intubation time in seconds was significantly shorter in Group G (70.85 ± 8.88 S) than in Group F (90.26 ± 9.41 S) with ( P < 0.001). The success rate of the first attempt intubation was slightly higher in Group G (81.5%) than Group F (78.8%). Cormack and Lehane glottic Score I and II showed insignificant difference between both Group G (92.6%) and Group F (96.3%). We detected three cases of sore throat in each group.
CONCLUSION
GlideScope ® could be a suitable alternative to FFS in nasal intubation of oropharyngeal cancer patients.
| 1significant effect
|
5,747,224 | 29,296,600 |
BACKGROUND
Studies have found that nearly 90% of the first use of tobacco takes place before high school graduation (teenagers) and training discussion due to prevention can be useful, therefore, here, we aimed to determine the effects of training on awareness of cigarette outcomes (physical and psychological) in male teenagers.
MATERIALS AND METHODS
We conducted an interventional study using Solomon's four-group plan, which used a two-stage cluster sampling in four groups (two experimental groups and two control groups). The three sessions of at least 2 h of education intervention including visual displaying using photo, film, and short scientific texts were held for the interventional group. After 1 month, all four groups took posttest, and research groups were followed up after 8 months of intervention. All data were analyzed using one-way analysis of variance and covariance in SPSS.
RESULTS
According to the results, the mean of posttest scores had increased rather than pretest scores, and generally, a significant difference was observed ( P ≤ 0.001). These results were significant in the aspect of both physical and psychological outcomes awareness. The difference between the mean of scores in follow-up period and posttest was not statistically significant, and it shows training retention after 8 months ( P < 0.666).
CONCLUSIONS
It can be concluded that through the training, it is possible to increase the awareness of teenagers about physical and psychological outcomes of cigarette smoking that this can have an important role in smoking prevention.
| 1significant effect
|
2,671,107 | 19,196,886 |
OBJECTIVE
This study tested the hypothesis that phosphodiesterase 5 inhibition alone or in combination with ACE inhibition improves glucose homeostasis and fibrinolysis in individuals with metabolic syndrome.
RESEARCH DESIGN AND METHODS
Insulin sensitivity, beta-cell function, and fibrinolytic parameters were measured in 18 adults with metabolic syndrome on 4 separate days after a randomized, crossover, double-blind, 3-week treatment with placebo, ramipril (10 mg/day), tadalafil (10 mg o.d.), and ramipril plus tadalafil.
RESULTS
Ramipril decreased systolic and diastolic blood pressure, ACE activity, and angiotensin II and increased plasma renin activity. Ramipril did not affect insulin sensitivity or beta-cell function. In contrast, tadalafil improved beta-cell function (P = 0.01). This effect was observed in women (331.9 +/- 209.3 vs. 154.4 +/- 48.0 32 micro x mmol(-1) x l(-1), respectively, for tadalafil treatment vs. placebo; P = 0.01) but not in men. There was no effect of any treatment on fibrinolysis. CONCLUSIONS Phosphodiesterase 5 inhibition may represent a novel strategy for improving beta-cell function in metabolic syndrome.
| 0no significant effect
|
5,440,538 | 28,332,096 |
BACKGROUND
Elevated intact parathyroid hormone (iPTH) levels can contribute to morbidity and mortality in children with chronic kidney disease (CKD). We evaluated the pharmacokinetics, efficacy, and safety of oral paricalcitol in reducing iPTH levels in children with stages 3-5 CKD.
METHODS
Children aged 10-16 years with stages 3-5 CKD were enrolled in two phase 3 studies. The stage 3/4 CKD study characterized paricalcitol pharmacokinetics and compared the efficacy and safety of paricalcitol with placebo followed by an open-label period. The stage 5 CKD study evaluated the efficacy and safety of paricalcitol (no comparator) in children with stage 5 CKD undergoing dialysis.
RESULTS
In the stage 3/4 CKD study, mean peak plasma concentration and area under the time curve from zero to infinity were 0.13 ng/mL and 2.87 ng•h/((or ng×h/))mL, respectively, for 12 children who received 3 μg paricalcitol. Thirty-six children were randomized to paricalcitol or placebo; 27.8% of the paricalcitol group achieved two consecutive iPTH reductions of ≥30% from baseline versus none of the placebo group (P = 0.045). Adverse events were higher in children who received placebo than in those administered paricalcitol during the double-blind treatment (88.9 vs. 38.9%; P = 0.005). In the stage 5 CKD study, eight children (61.5%) had two consecutive iPTH reductions of ≥30% from baseline, and five (38.5%) had two consecutive iPTH values of between 150 and 300 pg/mL. Clinically meaningful hypercalcemia occurred in 21% of children.
CONCLUSIONS
Oral paricalcitol in children aged 10-16 years with stages 3-5 CKD reduced iPTH levels and the treatment was well tolerated. Results support an initiating dose of 1 μg paricalcitol 3 times weekly in children aged 10-16 years.
| 1significant effect
|
4,805,129 | 26,250,435 |
BACKGROUND
Iron deficiency anaemia is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer®) and oral iron in NDD-CKD patients with renal-related anaemia.
METHODS
The trial was a Phase III open-label, comparative, multicentre, non-inferiority trial conducted in 351 iron-deficient NDD-CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B). The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min). A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4.
RESULTS
Iron isomaltoside 1000 was both non-inferior to oral iron at Week 4 (P < 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P = 0.009 at Week 3). The haemoglobin response was more pronounced with iron isomaltoside 1000 doses ≥1000 mg (P < 0.05). Serum-ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9%, P = 0.2).
CONCLUSIONS
Iron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD-CKD patients.
| 1significant effect
|
2,841,147 | 20,193,079 |
UNLABELLED
GSK256066 is a selective phosphodiesterase 4 inhibitor that can be given by inhalation, minimising the potential for side effects. We evaluated the effects of GSK256066 on airway responses to allergen challenge in mild asthmatics.
METHODS
In a randomised, double blind, cross-over study, 24 steroid naive atopic asthmatics with both early (EAR) and late (LAR) responses to inhaled allergen received inhaled GSK256066 87.5 mcg once per day and placebo for 7 days, followed by allergen challenge. Methacholine reactivity was measured 24 h post-allergen. Plasma pharmacokinetics were measured. The primary endpoint was the effect on LAR.
RESULTS
GSK256066 significantly reduced the LAR, attenuating the fall in minimum and weighted mean FEV1 by 26.2% (p = 0.007) and 34.3% (p = 0.005) respectively compared to placebo. GSK256066 significantly reduced the EAR, inhibiting the fall in minimum and weighted mean FEV1 by 40.9% (p = 0.014) and 57.2% (p = 0.014) respectively compared to placebo. There was no effect on pre-allergen FEV1 or methacholine reactivity post allergen. GSK256066 was well tolerated, with low systemic exposure; plasma levels were not measurable after 4 hours in the majority of subjects.
CONCLUSIONS
GSK256066 demonstrated a protective effect on the EAR and LAR. This is the first inhaled PDE4 inhibitor to show therapeutic potential in asthma.
| 1significant effect
|
4,319,300 | 25,713,485 |
OBJECTIVE
Generalized aggressive periodontitis (GAgP) is a complex periodontal disease affecting the entire dentition with a rapid destruction of the periodontium and resulting in loss of teeth. We hypothesized that better clinical healing of adjunctive use of amoxicillin plus metronidazole combination may be related to the effect of this combination therapy to restore imbalance between matrix metalloproteinases (MMP) and their tissue inhibitors (TIMP) which is associated with connective tissue and alveolar bone destruction in patients with GAgP.
MATERIALS AND METHODS
Twenty-eight subjects diagnosed with GAgP were recruited. Patients were randomly assigned to test or control groups. MMP-1/TIMP-1 ratio was compared between groups receiving scaling and root planning (SRP) alone (control) or in combination with amoxicillin plus metronidazole (test). Clinical periodontal variables were measured. Gingival crevicular fluid samples were obtained and analyzed for MMP-1 and TIMP-1. Measurements were taken at baseline and repeated at 3 and 6 months after therapy.
RESULTS
Total MMP-1 levels were significantly decreased in both groups (P < 0.05) at 3 and 6 months. MMP-1 concentration levels showed a similar pattern to MMP-1 total levels decreasing significantly at 3 months (P < 0.05). TIMP-1 concentration levels increased in the test group throughout the study period, while the difference did not reach statistical significance (P > 0.05). TIMP-1/MMP-1 balance was restored in test group at 6 months significantly better than the control group (P < 0.05).
CONCLUSION
The results of this study suggest that metronidazole and amoxicillin combination as an adjunct to SRP results in better clinical healing through restoring TIMP-1/MMP-1 balance.
| 1significant effect
|
5,415,292 | 28,516,127 |
CONTEXT
The American Academy of Pediatrics and professional guidelines recommend intervening with adolescents about avoiding tobacco use in the health-care setting. Barriers in the clinical setting limit consistent provision of this critical service.
OBJECTIVES
This pilot study compared 2 approaches for referring adolescents to an evidence-based tobacco prevention and cessation program in the outpatient setting. Secondary aims assessed tobacco use, knowledge, and program evaluation.
DESIGN SETTING AND PARTICIPANTS
The study setting was a medical and dental clinic. Participants aged 13 to 18 received tobacco advice and instructions to work through "A Smoking Prevention Interactive Experience." The program addresses health concerns of adolescents about tobacco use and is founded on behavioral change theories. The link to access it is featured on the website of the National Cancer Institute's Research-Tested Interventions. Participants (N = 197) were randomized to 1 of 2 approaches (ie, a program link via e-mail or referral by a printed card).
RESULTS
The program was accessed by 57% (112 of 197) of participants. Both referral approaches were equally effective. Non-Hispanics were twice as likely to access the program as Hispanics (adjusted odds ratio = 2.1, 95% confidence interval = 1.2-3.8, P < .05). Over 95% of participants identified themselves as nonusers of tobacco and evaluated the program as beneficial in increasing knowledge and motivation to remain tobacco-free.
CONCLUSION
Linking adolescent patients to an evidence-based tobacco prevention/cessation program at a community health clinic was highly promising and feasible. We present conclusions for future research.
| 1significant effect
|
4,682,219 | 26,674,353 |
BACKGROUND
HPV FOCAL is a randomized trial (ISRCTN79347302, registered 20 Apr 2007) comparing high-risk (hr) HPV testing vs. liquid-based cytology (LBC) for cervical cancer screening of women aged 25-65. We compared the Digene Hybrid Capture® 2 High-Risk HPV DNA Test® (HC2) and the Roche cobas® 4800 HPV Test (COBAS) for primary screening.
METHODS
Women (n=6,172) were screened at baseline by HC2 and COBAS and by LBC 24 months later. We assessed HPV genotyping and reflex LBC for colposcopy triage of baseline HPV positive women.
RESULTS
Overall HC2/COBAS agreement was 96.1% (kappa 0.75) and positive agreement was 77.5%. Baseline CIN2 and CIN3+ rates based on HPV screening were 8.6/1,000 and 6.6/1,000 respectively; 24 month rates were 0.7/1,000 and 0.4/1,000 (LBC screening). HC2 and COBAS were concordant positive for 91% of round 1 CIN2 and 98% of CIN3+. CIN3+ was significantly associated with HPV 16 (Odds Ratio [OR] 5.11; 95% confidence interval [CI] 2.30, 11.37), but not HPV 18 (OR 2.62; 95% CI 0.73, 9.49), vs. non-HPV 16/18 HPV at baseline. There was no significant association between HPV genotype and CIN2. CIN3+ was significantly more likely for high-grade (OR 5.99; 95% CI 2.53, 14.18), but not low-grade (OR 0.54; 95% CI 0.20, 1.49), vs. negative LBC. No significant association was observed between LBC grade and CIN2. HPV 16 and 18 were associated with 33% of CIN2 and 68% of CIN3+ identified at baseline.
CONCLUSIONS
For hrHPV positive women, abnormal reflex LBC is appropriate for colposcopy triage. In addition, immediate referral of women with HPV 16/18 and normal cytology may allow for earlier detection of CIN2+ lesions which would not be detected until after follow-up testing.
| 1significant effect
|
1,618,957 | 16,918,950 |
OBJECTIVE AND DESIGN
Depot somatostatin analogues are well accepted as either adjuvant or primary therapy for acromegaly, and their long dosage intervals facilitate adherence to treatment. Our objective was to evaluate whether lanreotide Autogel 120 mg, every 4-8 weeks, was as effective in controlling acromegaly as lanreotide microparticles 30 mg, every 1-2 weeks. PATIENTS DESIGN AND MEASUREMENTS: Patients who had used lanreotide microparticles 30 mg, >or= 2 months prestudy, and had responded to treatment were recruited to this open, prospective, multicentre phase III trial. Three to five injections of lanreotide Autogel 120 mg were administered. Lanreotide Autogel 120 mg was injected every 4, 6 or 8 weeks in patients previously receiving lanreotide microparticles every 7, 10 or 14 days, respectively. GH and insulin-like growth factor (IGF)-1 levels were assessed one dosing interval after the final injections.
RESULTS
Ninety-eight patients were enrolled and 93 completed. Steady-state GH concentrations demonstrated similar efficacy between the formulations (upper 95% confidence interval of the quotient, 77.7%). Mean (SE) GH levels were lower with lanreotide Autogel than with lanreotide microparticles (3.8 (0.5) vs 4.3 (0.5) ng/ml; P < 0.001). GH levels < 2.5 ng/ml were observed in 54% and 46% of patients; 40% and 35% having GH < 2.5 ng/ml and normalized IGF-1 with lanreotide Autogel and microparticles, respectively. Symptoms were controlled better with lanreotide Autogel and treatment was well accepted.
CONCLUSIONS
Lanreotide Autogel 120 mg every 4-8 weeks, is at least as effective and as well tolerated in acromegaly as lanreotide microparticles 30 mg injected every 7-14 days.
| 1significant effect
|
4,477,769 | 26,120,418 |
BACKGROUND
Family-centered care (FCC) involves holistic care and requires cooperation with the family in planning, intervention, and the evolution of the care that is being provided. Many previous studies have provided results that indicate the importance of the family's involvement in pediatric care, but there is still resistance in doing so within the organizational culture of the hospitals in Iran. The aim of this study was to determine the effects of FCC on the satisfaction of parents of children hospitalized in 2012 in the pediatric ward at Razi Hospital in Chaloos, Iran.
METHODS
This Quasi-experimental study was conducted in 2012 in the pediatric ward at Razi Hospital in Chaloos, Iran. Seventy hospitalized children between the ages of 1 and 3 who suffered from diarrhea, vomiting, or pneumonia were selected through convenience sampling. They were divided randomly into two equal groups, a control group (routine care) and an experimental group (family-centered care). SPSS Statistics 14 software was used to analyze the data, and p<0.05 was considered to be significant.
RESULTS
In the FCC group, the mean score of satisfaction among the parents of the children was 20 out of 90 before the intervention, but, after the FCC method was used, it increased to 83.2 out of 90. In addition, a significant difference was found between the scores of satisfaction for the control and experimental groups (p<0.001), and all parents of children in the experimental group expressed high satisfaction.
CONCLUSION
Our findings showed that the practice of FCC in caring for the sick children can increase the satisfaction of their parents significantly. The role of the family's involvement is critical in every component of the intervention efforts, as shown by the constructs of participatory support, educational support, and psychological support. Thus, a notable implication here is that FCC may lead to increased quality of care and should be included in the educational programs of the nursing staff in pediatric ward.
| 1significant effect
|
4,090,726 | 24,874,483 |
BACKGROUND
Stratification of patients for treatment of ductal carcinoma in situ (DCIS) is suboptimal, with high systemic overtreatment rates.
METHODS
A training set of 95 tumours from women with pure DCIS were immunostained for proteins involved in cell survival, hypoxia, growth factor and hormone signalling. A generalised linear regression with regularisation and variable selection was applied to a multiple covariate Cox survival analysis with recurrence-free survival 10-fold cross-validation and leave-one-out iterative approach were used to build and test the model that was validated using an independent cohort of 58 patients with pure DCIS. The clinical role of a COX-2-targeting agent was then tested in a proof-of-concept neoadjuvant randomised trial in ER-positive DCIS treated with exemestane 25 mg day(-1)± celecoxib 800 mg day(-1).
RESULTS
The COX-2 expression was an independent prognostic factor for early relapse in the training (HR 37.47 (95% CI: 5.56-252.74) P=0.0001) and independent validation cohort (HR 3.9 (95% CI: 1.8-8.3) P=0.002). There was no significant interaction with other clinicopathological variables. A statistically significant reduction of Ki-67 expression after treatment with exemestane ± celecoxib was observed (P<0.02) with greater reduction in the combination arm (P<0.004). Concomitant reduction in COX-2 expression was statistically significant in the exemestane and celecoxib arm (P<0.03) only.
CONCLUSIONS
In patients with DCIS, COX-2 may predict recurrence, aiding clinical decision making. A combination of an aromatase inhibitor and celecoxib has significant biological effect and may be integrated into treatment of COX2-positive DCIS at high risk of recurrence.
| 1significant effect
|
3,954,418 | 24,127,265 |
INTRODUCTION
Previous studies have found partners' smoking status, multiparity, and nicotine dependence to be associated with smoking cessation in pregnancy. However, no studies have investigated influences on cessation among women using nicotine replacement therapy (NRT). We analyzed data from a trial of NRT in pregnancy to determine factors associated with shorter- and longer-term cessation.
METHODS
Data were collected at baseline, 1 month, and delivery from 1,050 pregnant women. Two multivariable logistic models for validated cessation at 1 month and delivery were created with a systematic strategy for selection of included factors.
RESULTS
All findings are from multivariable analyses. At 1 month, odds of cessation were greater among those who completed full time education at >16 years of age (odds ratio [OR] = 1.82, 95% confidence interval CI = 1.24-2.67, p = .002) but they were lower in women with higher baseline cotinine levels (OR = 0.93, 95% CI = 0.90-0.95, p < .001). At delivery, the odds of cessation were greater among those who completed full time education at >16 years of age (OR = 1.89, 95% CI = 1.16-3.07, p = 0.010) but were inversely associated with higher baseline cotinine levels (OR = 0.96, 95% CI = 0.92-0.99, p = .010).
CONCLUSIONS
Women who are better educated and have lower pretreatment cotinine concentrations had higher odds of stopping smoking and factors associated with shorter and longer term cessation were similar.
| 1significant effect
|
4,883,760 | 27,233,041 |
PURPOSE
To compare the effectiveness of an educational board game with interactive didactic instruction for teaching optometry students elements of the core optometric curriculum.
METHODS
Forty-two optometry students were divided into two GPA-matched groups and assigned to either 12 hours of game play (game group) or 12 hours of interactive didactic instruction (lecture group). The same material from the core optometric curriculum was delivered to both groups. Game play was accomplished via an original board game. Written examinations assessed change in knowledge level. A post-intervention opinion survey assessed student attitudes.
RESULTS
There was no significant difference in pre- or post-intervention test scores between the lecture and game groups (Pre-test: p = 0.9; Post-test: p = 0.5). Post-intervention test scores increased significantly from baseline (Game group: 29.3% gain, Didactic group: 31.5% gain; p<0.001 for each). The score increase difference between groups was not statistically significant (p = 0.6). The post-intervention attitude survey did not reveal any significant between group differences (p = 0.5).
CONCLUSIONS
Our results indicate that an educational game and interactive didactic instruction can be equally effective in teaching optometry students basic and applied science. Furthermore, both modes of instruction have the potential to be equally engaging and enjoyable experiences.
| 1significant effect
|
3,267,522 | 22,291,473 |
BACKGROUND
Adult weight gain and obesity have become worldwide problems. Issues of cost and potential side effects of prescription weight loss drugs have led overweight and obese adults to try nutraceuticals that may aid weight loss. One promising nutraceutical is green coffee extract, which contains high concentrations of chlorogenic acids that are known to have health benefits and to influence glucose and fat metabolism. A 22-week crossover study was conducted to examine the efficacy and safety of a commercial green coffee extract product GCA™ at reducing weight and body mass in 16 overweight adults.
METHODS
Subjects received high-dose GCA (1050 mg), low-dose GCA (700 mg), or placebo in separate six-week treatment periods followed by two-week washout periods to reduce any influence of preceding treatment. Treatments were counterbalanced between subjects. Primary measurements were body weight, body mass index, and percent body fat. Heart rate and blood pressure were also measured.
RESULTS
Significant reductions were observed in body weight (-8.04 ± 2.31 kg), body mass index (-2.92 ± 0.85 kg/m(2)), and percent body fat (-4.44% ± 2.00%), as well as a small decrease in heart rate (-2.56 ± 2.85 beats per minute), but with no significant changes to diet over the course of the study. Importantly, the decreases occurred when subjects were taking GCA. Body mass index for six subjects shifted from preobesity to the normal weight range (<25.00 kg/m(2)).
CONCLUSION
The results are consistent with human and animal studies and a meta-analysis of the efficacy of green coffee extract in weight loss. The results suggest that GCA may be an effective nutraceutical in reducing weight in preobese adults, and may be an inexpensive means of preventing obesity in overweight adults.
| 1significant effect
|
1,489,930 | 16,709,243 |
BACKGROUND
Epidemiologic data have shown that the prevalence of Type 2 diabetes varies with ethnic origin. Type 2 diabetes is up to four times more common in British South Asians than in the indigenous white population. The aim of this study was to develop a culturally appropriate educational intervention programme for South Asians with Type 2 diabetes. We then investigated whether this intervention could produce an improvement, and finally whether any improvement was greater than background changes in knowledge in comparison groups.
METHODS
A multi-site prospective, randomised controlled study was conducted in all day care centres and three general practice registers with high proportion patients from different ethnic minority groups in Glasgow, Scotland. The intervention consisted of 18 educational sessions in 6 separate programmes. A modified questionnaire was used to measure the knowledge, attitudes, and practice of diabetes before and after intervention.
RESULTS
Baseline assessment showed that Indian and Pakistani subjects had less knowledge about diabetes, regarded the disease less seriously, and had a lesser understanding of the relationship between control and complications than the white population. No differences in initial responses were found between those who completed the second assessment and those who did not. The intervention group showed significant improvements in scores for Knowledge (+12.5%); Attitudes toward seriousness (+13.5%), complications (+8.1%), Practice (+20.0%). However there were also changes in the ethnic control group scores; respectively +5.0%, +16.3% (significant P < 0.001), +1.5%, +1.7%. The single white control group also showed some improvements; respectively +12.2%, +12.4% (P = 0.04), +6.0%, +25.0% (P = 0.007), but the differences in improvement between these two control groups were not significant. Overall, the improvement seen was similar in both intervention and ethnic control groups and there was no significant difference in the amount of change (P = 0.36 CI -0.9 to +2.6).
CONCLUSION
This study has shown that conducting a culturally-competent educational intervention in patients with Type 2 diabetes from ethnic minority groups is feasible and can improve their knowledge and attitudes and practice. However there was no net benefit compared with the control group.
| 1significant effect
|
3,961,877 | 24,665,438 |
BACKGROUND
Oral mucositis is the most frequently occurring painful and dose-limiting side-effect of radiation of the head and neck region. Few studies demonstrated that oral glutamine suspension may significantly reduce the duration and severity of objective oral mucositis during radiotherapy.
MATERIALS AND METHODS
A randomized, prospective single institutional case control study was performed between April 2012 and November 2012 comparing the influence of oral glutamine on radiation induced mucositis in head and neck malignancy patients. Seventy biopsy proven patients with head and neck cancer receiving primary or adjuvant radiation therapy were randomized to receive either oral glutamine suspension daily 2h before radiation in the study arm (10 g in 1000 ml of water) (n = 35) or nothing before radiation; control arm (n = 35).
RESULTS AND ANALYSIS
Total 32 patients (91.43%) in the glutamine arm and total 34 patients (97.15%) developed mucositis. Grade 3 mucositis (14.29%) and grade 4 mucositis (2.86%) in the study arm (who received oral glutamine) were significantly less (P = 0.02 and P = 0.04, respectively) in the glutamine arm. The mean duration of grade 3 or worse mucositis (grade 3 and grade 4) was significantly less (6.6 days vs. 9.2 days) in study arm with P < 0.001. Mean time of onset of mucositis was significantly delayed in patients who took glutamine in comparison to control arm with P < 0.001.
CONCLUSION
Glutamine delays oral mucositis in the head neck cancer patients. Moreover, it reduces the frequency and duration of grade 3 and grade 4 mucositis.
| 1significant effect
|
5,450,266 | 28,558,833 |
BACKGROUND
'Clinically important deterioration' (CID) is a composite endpoint measuring worsening of the key clinical features of chronic obstructive pulmonary disease (COPD), namely lung function, patient-reported outcomes, and exacerbations. ACLIFORM and AUGMENT were two 24-week, randomized, double-blind, phase III studies assessing twice-daily (BID) aclidinium bromide (AB) 400 μg/formoterol fumarate (FF) 12 μg. This pooled post-hoc analysis assessed the effects of AB/FF 400/12 μg on both first and sustained CID events versus placebo and monotherapies in patients with moderate to severe COPD.
METHODS
A first CID event was defined as the occurrence of a moderate/severe exacerbation or the worsening from baseline in ≥1 of the following: trough forced expiratory volume in 1 second (FEV 1 ; ≥100 mL), Transition Dyspnea Index (TDI) focal score (≥1 unit), or St George's Respiratory Questionnaire (SGRQ) total score (≥4 units). A 'sustained' CID was defined as a worsening maintained at all subsequent visits from appearance to week 24 or a moderate/severe exacerbation at any time. CID events were assessed at three visits (weeks 4, 12, and 24); trough FEV 1 was also measured at weeks 1 and 18.
RESULTS
AB/FF 400/12 μg reduced the risk of a first CID event by 45% versus placebo (hazard ratio [HR] 0.55, p < 0.001), 18% versus FF 12 μg (HR 0.82, p < 0.01), and 15% versus AB 400 μg (HR 0.85, p < 0.05). Similarly, AB/FF 400/12 μg reduced the risk of a sustained CID event by 48% versus placebo (HR 0.52, p < 0.001) and 22% versus FF 12 μg (HR 0.78, p < 0.01). AB/FF 400/12 μg reduced the risk of a first or sustained CID event for all four components versus placebo (trough FEV 1 and TDI, first and sustained CID, all p < 0.001; SGRQ first CID p < 0.001; SGRQ sustained CID, p < 0.01; exacerbations first and sustained CID, both p < 0.05) and TDI and SGRQ versus FF 12 μg (TDI, first and sustained CID both p < 0.05; SGRQ first CID p < 0.01), and SGRQ versus AB 400 μg (first CID, p < 0.05).
CONCLUSIONS
AB/FF 400/12 μg BID may provide greater airway stability and fewer exacerbations or deteriorations in lung function, health status, or dyspnea compared with placebo or monotherapies.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01462942 (ACLIFORM); registered 26 October 2011. Clinicaltrials.gov NCT01437397 (AUGMENT); registered 19 September 2011.
| 1significant effect
|
5,568,359 | 28,830,474 |
BACKGROUND
The total number of cardiovascular (CVD) deaths accounted for almost a third of all deaths globally in 2013. Population based randomised controlled trials, managed within primary care, on CVD risk factor interventions are scarce. The aim of the study was to evaluate the effects of a health dialogue intervention in a primary care setting offered to a population at the age of 55 years, focusing on CVD risk factors.
METHODS
The study was performed in five primary health care centres in the county of Västmanland, Sweden between April 2011 and December 2012. Men and women were randomly assigned to intervention (n = 440) and control groups (n = 440). At baseline, both groups filled in a health questionnaire and serum cholesterol, fasting plasma glucose, glycated haemoglobin (HbA1c), weight, height, waist (WC) and hip circumference, waist hip ratio (WHR) and systolic/diastolic blood pressure were measured. Intervention group attended a health dialogue, supported by a visualised health profile, with a possibility for further activities. Participation rates at baseline were 53% and 52% respectively. A 1-year follow-up was carried out.
RESULTS
The intervention group (n = 165) showed reductions compared to the control group (n = 177) concerning body mass index (BMI) (0.3 kg/m 2 , p = .031), WC (2.1 cm, p ≤ .001) and WHR (.002, p ≤ .001) at the 1-year follow-up. No differences between the intervention and control groups were found in other variables. Intervention group, compared to baseline, had reduced weight, BMI, WC, WHR, HbA1c, and diet, while the men in the control group had reduced their alcohol consumption.
CONCLUSIONS
A health dialogue intervention at the age of 55 years, conducted in ordinary primary care, showed a moderate effect on CVD risk factor levels, in terms of BMI, WC and WHR.
TRIAL REGISTRATION NUMBER
BioMed Central, ISRCTN22586871 , date assigned; 10/12/2015.
| 1significant effect
|
5,874,977 | 29,736,280 |
PURPOSE
Visual loss is a devastating perioperative complication that can result from elevated intraocular pressure (IOP). The Trendelenburg position during surgery increases IOP. The purpose of this study was to quantify IOP changes in patients undergoing laparoscopic hysterectomy, at different time points and body positions throughout the procedure, and to compare fluctuations of IOP during the perioperative period according to two fluid management protocols.
METHODS
Thirty women scheduled to undergo elective gynecologic laparoscopic pelvic surgery were randomly allocated to receive a liberal or restrictive fluid management protocol. IOP, mean arterial pressure, heart rate, exhaled tidal volume, end-tidal CO 2 , and ocular perfusion pressure were assessed prior, during, and postsurgery, at 8 time points altogether.
RESULTS
Mean changes in IOP were similar for the two protocols; the peak IOP was at the steep (peak) Trendelenburg position. For each protocol, IOP correlated positively with mean arterial pressure, and mean blood pressure correlated with ocular perfusion pressure.
CONCLUSION
IOP was elevated during laparoscopic pelvic surgery and particularly at the steep Trendelenburg position. No differences were found in any of the parameters examined according to a liberal or restrictive fluid management protocol.
| 0no significant effect
|
5,433,398 | 28,607,706 |
BACKGROUND
Disabled multiple sclerosis (MS) patients often need intervention of multiple specialists, resulting in a complex organization of care. How this multidisciplinary care should be organized and structured has not been studied.
OBJECTIVE
The objective of this article is to address the effectiveness of an integrated multidisciplinary approach versus usual care in MS patients.
METHODS
This is a prospective, randomized, controlled, monocentric clinical trial in MS patients. Two treatment strategies were compared: (i) an integrated multidisciplinary (IMD) approach, consisting of a half-day individually tailored comprehensive assessment in the MS clinic; and (ii) a standard care. The primary outcome was the impact of the strategy on quality of life (QoL) measured using the MSIS-29 scale at inclusion and after six months.
RESULTS
Fifty MS patients were included. Median MSIS 29 score decreased over six months in the control group (-4.89) and increased in the IMD group (+2.00), with a significant difference between the two groups ( p = 0.03). However, in the multivariate analysis, after adjustment of HAD-D and INTERMED score, this difference was no longer significant.
CONCLUSIONS
This prospective, randomized study is the first attempt to evaluate the multidisciplinary approach in MS patients. The results show that, contrary to our expectations, an integrated multidisciplinary approach is not superior to usual care on QoL.
| 1significant effect
|
3,161,280 | 21,775,756 |
OBJECTIVE
Insulin secretion is often diminished in hyperglycemic patients with type 2 diabetes. We examined whether chronic basal insulin treatment with insulin glargine improves glucose-induced insulin secretion.
RESEARCH DESIGN AND METHODS
Fourteen patients with type 2 diabetes on metformin monotherapy received an add-on therapy with insulin glargine over 8 weeks. Intravenous glucose tolerance tests (IVGTTs) were performed before and after the intervention, with and without previous adjustment of fasting glucose levels using a 3-h intravenous insulin infusion.
RESULTS
Fasting glycemia was lowered from 179.6 ± 7.5 to 117.6 ± 6.5 mg/dL (P < 0.001), and HbA(1c) levels declined from 8.4 ± 0.5 to 7.1 ± 0.2% (P = 0.0046). The final insulin dose was 59.3 ± 10.2 IU. Acute normalization of fasting glycemia by intravenous insulin reduced C-peptide levels during the IVGTT (P < 0.0001). In contrast, insulin and C-peptide responses to intravenous glucose administration were significantly greater after the glargine treatment period (P < 0.0001, respectively). Both first- and second-phase insulin secretion increased significantly after the glargine treatment period (P < 0.05, respectively). These improvements in insulin secretion were observed during both the experiments with and without acute adjustment of fasting glycemia.
CONCLUSIONS
Chronic supplementation of long-acting basal insulin improves glucose-induced insulin secretion in hyperglycemic patients with type 2 diabetes, whereas acute exogenous insulin administration reduces the β-cell response to glucose administration. These data provide a rationale for basal insulin treatment regiments to improve postprandial endogenous insulin secretion in hyperglycemic patients with type 2 diabetes.
| 1significant effect
|
3,144,604 | 21,829,278 |
OBJECTIVE
To study the efficacy of yoga on Guna (yogic personality measure) and general health in normal adults.
METHODS
Of the 1228 persons who attended introductory lectures, 226 subjects aged 18-71 years, of both sexes, who satisfied the inclusion and exclusion criteria and who consented to participate in the study were randomly allocated into two groups. The Yoga(Y) group practised an integrated yoga module that included asanas, pranayama, meditation, notional correction and devotional sessions. The control group practised mild to moderate physical exercises (PE). Both groups had supervised practice sessions (by trained experts) for one hour daily, six days a week for eight weeks. Guna (yogic personality) was assessed before and after eight weeks using the self-administered Vedic Personality Inventory (VPI) which assesses Sattva (gentle and controlled), Rajas (violent and uncontrolled) and Tamas (dull and uncontrolled). The general health status (total health), which includes four domains namely somatic symptoms (SS), anxiety and insomnia (AI), social dysfunction (SF) and severe depression (SP), was assessed using a General Health Questionnaire (GHQ).
RESULTS
Baseline scores for all the domains for both the groups did not differ significantly (P > 0.05, independent samples t test). Sattva showed a significant difference within the groups and the effect size was more in the Y than in the PE group. Rajas showed a significant decrease within and between the groups with a higher effect size in the PE group. Tamas showed significant reduction within the PE group only. The GHQ revealed that there was significant decrease in SS, AI, SF and SP in both Y and PE groups (Wilcoxcon Singed Rank t test). SS showed a significant difference between the groups (Mann Whitney U Test).
CONCLUSIONS
There was an improvement in Sattva in both the Yoga and control groups with a trend of higher effect size in Yoga; Rajas reduced in both but significantly better in PE than in Yoga and Tamas reduced in PE. The general health status improved in both the Yoga and control groups.
| 1significant effect
|
5,282,794 | 28,143,599 |
BACKGROUND
Vaginal delivery, especially operative assisted vaginal delivery, seems to be a major stressor for the neonate. The objective of this study was to evaluate the stress response after metal cup versus Kiwi Omnicup® ventouse delivery.
METHODS
The study was a secondary observational analysis of data from a former prospective randomised placebo controlled multicentre study on the analgesic effect of acetaminophen in neonates after operative vaginal delivery and took place at three Swiss tertiary hospitals. Healthy pregnant women ≥35 weeks of gestation with an estimated fetal birth weight above 2000 g were recruited after admission to the labour ward. Pain reaction was analysed by pain expression score EDIN scale (Échelle Douleur Inconfort Nouveau-Né, neonatal pain and discomfort scale) directly after delivery. For measurement of the biochemical stress response, salivary cortisol as well as the Bernese Pain Scale of Newborns (BPSN) were evaluated before and after an acute pain stimulus (the standard heel prick for metabolic testing (Guthrie test)) at 48-72 h.
RESULTS
Infants born by vaginal operative delivery displayed a lower pain response after plastic cup than metal cup ventouse delivery (p < 0.001), but the pain response was generally lower than expected and they recovered fully within 72 h.
CONCLUSIONS
Neonatal pain response is slightly reduced after use of Kiwi OmniCup® versus metal cup ventouse.
TRIAL REGISTRATION
Trial was registered under under NCT00488540 on 19th June 2007.
| 1significant effect
|
5,927,490 | 29,731,927 |
BACKGROUND
Matrix metalloproteinase-9 (MMP9) expression due to ischemic cause spreading of brain damage. Previous studies have reported that Bromelin was beneficial as anti-inflammation and prevent brain tissue damage.
AIM
This study aimed to determine the alteration of plasma MMP9 level after addition of Bromelin 500 mg to Standard therapy and its correlation with outcome in acute ischemic stroke.
METHODS
This was a preliminary report of a prospective randomised, double-blind study with pre and post-test design, forty-six acute ischemic stroke patients were randomly allocated with Bromelin and Standard groups. Measurement of MMP9 and outcome were performed before and after 14-days treatment.
RESULT
The Bromelin group showed a significant decrement of MMP9 level, from 6.02 ± 0.32 ng/ml before treatment to 5.50 ± 0.94 ng/ml after treatment (p = 0.028). There was a negative correlation between MMP9 level and mRS (r= -0.03; p = 0.905) and a positive correlation toward BI (r = 0.039; p = 0.859), while the Standard group showed increased MMP9 level from 5.82 ± 0.71 ng/ml to 5.91 ± 0.83 ng/ml (p = 0.616) which was correlated insignificantly to outcome.
CONCLUSION
We concluded that the addition of 500 mg Bromelin to standard ischemic stroke therapy reduced MMP9 level significantly and correlated to outcome improvement. However, there is a tight statistical correlation.
| 1significant effect
|
4,298,088 | 25,586,372 |
OBJECTIVE
This study aimed to test the hypothesis that the i-gel supraglottic airway device would fit the larynx and provide better sealing pressure if prewarmed to 42°C relative to the device kept at room temperature in non-paralysed, sedated patients.
METHODS
A total of 74 adult patients were assigned to the warm (i-gel prewarmed to 42°C; W group; 37 patients) or the control (i-gel kept at room temperature; C group; 37 patients) groups. Anaesthesia was induced with propofol and fentanyl. The i-gel was prewarmed to 42°C for 30 min before insertion in the W group, but kept at room temperature (approximately 23°C) for the C group. The number of attempts made until successful insertion and sealing pressure were compared between the two groups.
RESULTS
Insertion was successful with one attempt in 35 cases each for the W and C groups. Two attempts were needed in two cases for the W group and one case for the C group. There was one failed attempt in the C group, but none in the W group. None of the differences between the two groups were significant (p=0.51). Sealing pressure was slightly, but not significantly, higher in the W group than in the C group (W group 22.6±6.1 cm H2O; C group 20.7±6.1 cm H2O; p=0.15).
CONCLUSIONS
Prewarming of the i-gel to 42°C did not increase the success rate of insertion, nor did it significantly increase sealing pressure in anaesthetised, non-paralysed patients. Our data suggest that we can keep the i-gel at room temperature for emergency airway management for non-paralysed, sedated patients.
TRIAL REGISTRATION NUMBER
University Medical Information Network, Japan 000012287.
| 0no significant effect
|
5,168,495 | 27,903,564 |
OBJECTIVE
To determine if a targeted and tailored intervention based on a discussion informed by validated adherence scales will improve medication adherence.
DESIGN
Prospective randomised trial.
SETTING
2 community pharmacies in Brisbane, Australia.
METHODS
Patients recently initiated on a cardiovascular or oral hypoglycaemic medication within the past 4-12 weeks were recruited from two community pharmacies. Participants identified as non-adherent using the Medication Adherence Questionnaire (MAQ) were randomised into the intervention or control group. The intervention group received a tailored intervention based on a discussion informed by responses to the MAQ, Beliefs about Medicines Questionnaire-Specific and Brief Illness Perception Questionnaire. Adherence was measured using the MAQ at 3 and 6 months following the intervention.
RESULTS
A total of 408 patients were assessed for eligibility, from which 152 participants were enrolled into the study. 120 participants were identified as non-adherent using the MAQ and randomised to the 'intervention' or 'control' group. The mean MAQ score at baseline in the intervention and control were similar (1.58: 95% CI (1.38 to 1.78) and 1.60: 95% CI (1.43 to 1.77), respectively). There was a statistically significant improvement in adherence in the intervention group compared to control at 3 months (mean MAQ score 0.42: 95% CI (0.27 to 0.57) vs 1.58: 95% CI (1.42 to 1.75); p<0.001). The significant improvement in MAQ score in the intervention group compared to control was sustained at 6 months (0.48: 95% CI (0.31 to 0.65) vs 1.48: 95% CI (1.27 to 1.69); p<0.001).
CONCLUSIONS
An intervention that targeted non-adherent participants and tailored to participant-specific reasons for non-adherence was successful at improving medication adherence.
TRIAL REGISTRATION NUMBER
ACTRN12613000162718; Results.
| 1significant effect
|
4,300,351 | 25,653,731 |
INTRODUCTION
Peptic ulcer remains the most frequent cause of upper gastrointestinal bleeding. Treatment of bleeding with simultaneous combination of two endoscopic techniques has proved to be more efficient than monotherapy. None of the published comparative studies of various contact coagulation modalities have confirmed the superiority of one of these techniques over the others.
AIM
To compare the therapeutic outcomes of the use of a device enabling both injection of adrenaline solution and bipolar electrocoagulation (A + BE) to those of combined adrenaline injection with mechanical therapy (haemostatic clips) (A + HC) in the treatment of peptic ulcer bleeding.
MATERIAL AND METHODS
Fifty-two subjects with bleeding ulcers were assigned to the A + BE group, and 55 patients were treated with A + HC.
RESULTS
Overall, treatment failed in 20 patients (20/107, 18.7%): in 10 individuals from the A + BE group (10/52; 18.2%) and in 10 individuals from the A + HC group (10/55; 19.2%) (p > 0.05). Primary haemostasis was not obtained in 7 patients (6.5%): in 4 patients in the A + BE group and in 3 patients in the A + HC group (p > 0.05). Ten individuals (9.3%) experienced recurrent bleeding during hospitalisation: 4 patients from the A + BE group and 6 patients from the A + HC group (p > 0.05). Finally, in 96.3% of the patients (n = 103) the endoscopic treatment proved efficient with regards to obtaining haemostasis during hospitalisation. Surgical intervention was required in 4 individuals (3.7%): 2 patients in the A + BE group and 2 patients treated with A + HC (p > 0.05). Three patients (2.8%) - all from the A + HC group - died during hospitalisation. No significant intergroup differences were documented with regards to the mean number of transfused blood units and the mean length of hospital stay.
CONCLUSIONS
The efficacy of combined endoscopic treatment of ulcer bleeding with a probe enabling simultaneous bipolar electrocoagulation and adrenaline injection seems comparable to the widely used dual technique of adrenaline injection and haemostatic clipping.
| 0no significant effect
|
3,391,000 | 23,238,266 |
OBJECTIVES
We assessed the safety, efficacy, and tolerability of a new preparation of Gatorade and polyethylene glycol (PEG) for colonoscopy with or without bisacodyl compared with NuLYTELY.
METHODS
We performed an investigator-blinded, placebo-controlled, randomized trial of 64 oz of Gatorade and 306 g of PEG (G/PEG) with or without 10 mg of bisacodyl and NuLYTELY. A total of 600 outpatients consumed their preparation the day before a morning colonoscopy. The primary endpoint was colon cleanliness assessed by the Boston Bowel Preparation Scale (BBPS). Tolerability was assessed using a subject questionnaire, and safety was assessed from a basic metabolic profile drawn before the colonoscopy.
RESULTS
Adding bisacodyl to G/PEG caused more abdominal bloating/cramps (P<0.01) and did not result in a cleaner colon (P=0.66) compared with G/PEG without bisacodyl. The BBPS scores in both the G/PEG arms and NuLYTELY arm were not significantly different (P=0.19). Compared with subjects in the NuLYTELY arm, subjects in the G/PEG without bisacodyl arm had less nausea (P<0.04), vomiting (P<0.02), abdominal pain (P<0.02), bloating (P<0.005), difficulty drinking the liquid (P<0.0001), and found the overall preparation easier to tolerate (P<0.0001). Subjects in the combined G/PEG arms had a lower serum sodium (P<0.0007), chloride (P<0.007), and BUN (P<0.0001) levels than those in the NuLYTELY arm, but this did not cause any clinical symptoms.
CONCLUSIONS
Bisacodyl added to G/PEG for colon lavage caused more side effects and did not result in a cleaner colon. The G/PEG preparations cleansed the colon as well as NuLYTELY, were far better tolerated, and were equally safe.
| 0no significant effect
|
3,726,585 | 23,901,280 |
OBJECTIVE
This randomized crossover trial assessed the effects of 5 weeks of consuming low-fat dairy (one serving/day each of 1% fluid milk, low-fat cheese, and low-fat yogurt) versus nondairy products (one serving/day each of apple juice, pretzels, and cereal bar) on systolic and diastolic blood pressures (SBP and DBP), vascular function (reactive hyperemia index [RHI] and augmentation index), and plasma lipids.
METHODS
Patients were 62 men and women (mean age 54.5 years, body mass index 29.2 kg/m(2)) with prehypertension or stage 1 hypertension (mean resting SBP/DBP 129.8 mmHg/80.8 mmHg) while not receiving antihypertensive medications. A standard breakfast meal challenge including two servings of study products was administered at the end of each treatment period.
RESULTS
Dairy and nondairy treatments did not produce significantly different mean SBP or DBP in the resting postprandial state or from premeal to 3.5 hours postmeal (SBP, 126.3 mmHg versus 124.9 mmHg; DBP, 76.5 mmHg versus 75.7 mmHg), premeal (2.35 versus 2.20) or 2 hours postmeal (2.33 versus 2.30) RHI, and premeal (22.5 versus 23.8) or 2 hours postmeal (12.4 versus 13.2) augmentation index. Among subjects with endothelial dysfunction (RHI ≤ 1.67; n = 14) during the control treatment, premeal RHI was significantly higher in the dairy versus nondairy condition (2.32 versus 1.50, P = 0.002). Fasting lipoprotein lipid values were not significantly different between treatments overall, or in subgroup analyses.
CONCLUSION
No significant effects of consuming low-fat dairy products, compared with low-fat nondairy products, were observed for blood pressures, measures of vascular function, or lipid variables in the overall sample, but results from subgroup analyses were consistent with the hypothesis that dairy foods might improve RHI in those with endothelial dysfunction.
| 0no significant effect
|
3,381,083 | 22,737,365 |
PURPOSE
To compare the outcomes and complications of alcohol-assisted versus mechanical corneal epithelial debridement for photorefractive keratectomy (PRK).
METHODS
This randomized controlled trial included 1,250 eyes of 625 patients undergoing PRK for correction of myopia and myopic astigmatism. Each patient was randomly assigned to alcohol-assisted or mechanical epithelial removal.
RESULTS
A total of 658 eyes underwent alcohol-assisted epithelial removal while the epithelium was removed mechanically in 592 eyes. Mean spherical equivalent was -4.37±2.3 D in the alcohol group and -3.8±1.3 D in the mechanical group (P = 0.78). There was no significant difference in postoperative pain between the study groups (P = 0.22). Uncorrected visual acuity ≥ 20/20 and ≥ 20/40 was achieved in 90.9% versus 93.4% (P = 0.08), and 98.9% versus 99.5% (P = 0.36) of eyes in the alcohol and mechanical groups, respectively. Final refractive error within 1D of emmetropia was achieved in 90% versus 92.2% of eyes in the alcohol and mechanical groups, respectively (P = 0.23). Alcohol-assisted debridement required less time than mechanical debridement (96±18 vs. 118±26 seconds, P=0.035). There was no significant difference between the two groups in terms of early and late postoperative complications.
CONCLUSION
Alcohol-assisted and mechanical epithelium removal are comparable in terms of efficacy and side effects. The method of epithelial debridement in PRK may be left to the surgeon's choice.
| 0no significant effect
|
4,069,731 | 24,820,831 |
BACKGROUND & OBJECTIVES
Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India.
METHODS
In this open labelled, randomized controlled trial 2000 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools.
RESULTS
Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; P<0.001]. Also, there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; P<0.001]. There was significant reduction in average number of stools per day in LGG group (P<0.001) compared to the control group. These benefits were seen irrespective of rotavirus positivity in stool tests.
INTERPRETATION & CONCLUSIONS
Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group.
| 1significant effect
|
3,304,380 | 22,615,671 |
BACKGROUND AND THE PURPOSE OF THE STUDY
Extract of Boswellia Serrata species has been used in the Indian traditional medicine in the treatment of various inflammatory diseases. The present study was designed to evaluate anti-inflammatory effects of Frankincense in the treatment of gingivitis, which is a periodontal tissue inflammatory disease.
METHODS
This double blind randomized placebo controlled trial was carried out among high school female students with moderate plaque-induced gingivitis. Based on either administration of 0.1 gram of Frankincense extract or 0.2 gram of its powder or placebo and whether the patients undergone scaling and root planning (SRP) or not, they were randomly assigned to 6 groups. The primary efficacy outcome was changes in Gingival Index (Loe & Sillness) and the secondary outcomes were alteration in plaque index (Sillness & Loe), bleeding index (Cowell) and probing pocket depth (WHO probe). All indices were measured in the 0, 7th and 14th days of the study.
RESULTS
Seventy five patients ranged of 15-18 years old were enrolled. At the end of the study, the indices in all groups showed significant decreases in comparison to the first day (p< 0.05), except for the bleeding index in the group without SRP and drug therapy (p=0.111). More precise analysis of data revealed that SRP in association with Frankincense application (either extract or powder) can lead to remarkable decrease in inflammatory indices in comparison to the groups without SRP and drug therapy (p<0.001). In addition, no significant difference was observed between powder or extract therapy (p >0.05) and between patients received either SRP or treatment alone (p=0.169).
CONCLUSION
Frankincense, a safe and low-cost herbal medicine, may be feasibly applied to improve inflammation based disease of gingival as an adjunct to the conventional mechanical therapy.
| 1significant effect
|
3,790,036 | 24,101,959 |
BACKGROUND
Increased intra-abdominal pressure during laparoscopic surgery causes cephalad displacement of the diaphragm, resulting in the formation of atelectasis, which can be overcome by positive end-expiratory pressure (PEEP). The aim of this prospective study was to investigate the level of optimal PEEP to maintain adequate arterial oxygenation and hemodynamics during robot-assisted laparoscopic radical prostatectomy (RLRP).
METHODS
One hundred patients undergoing RLRP were randomly allocated to one of five groups (n = 20) (0, 3, 5, 7 and 10 cmH2O of PEEP). Hemodynamic variables and respiratory parameters were measured at baseline with the patient in the supine position; at 30 min, 1, 2, 3 and 4 h during CO2 insufflation with the patient in the post-Trendelenburg position; and after deflation in the supine position with increasing PEEP.
RESULTS
The PaO2 levels and alveolar-arterial difference in oxygen tension (AaDO2) were improved in patients with PEEPs compared with patients in whom PEEP was not used. The application of PEEP (10 cmH2O) resulted in higher PaO2 levels compared to those with lower PEEP levels, but excessive peak airway pressure (PAP) was sometimes observed. The application of a PEEP of 7 cmH2O resulted in similar PaO2 levels without causing excessive PAP. There was a significant difference in central venous pressure between the groups, but there were no significant differences in heart rate, mean arterial pressure or minute ventilation between the groups.
CONCLUSIONS
A PEEP of 7 cmH2O is associated with the greater improvement of PaO2 and AaDO2 without causing excessive PAP during RLRP.
| 1significant effect
|
3,170,595 | 21,819,556 |
BACKGROUND
Long-term immunosuppression is often required in myasthenia gravis (MG). There are no published trials using methotrexate (MTX) in MG. The steroid-sparing efficacy of azathioprine (AZA) has been demonstrated after 18-months of starting therapy. However, AZA is considered expensive in Africa. We evaluated the steroid-sparing efficacy of MTX (17.5 mg weekly) compared with AZA (2.5 mg/kg daily) in subjects recently diagnosed with generalized MG by assessing their average monthly prednisone requirements.
METHODS
The primary outcome was the average daily prednisone requirement by month between the two groups. Prednisone was given at the lowest dose to manage MG symptoms and adjusted as required according to protocol. Single-blinded assessments were performed 3-monthly for 2-years to determine the quantitative MG score and the MG activities of daily living score in order to determine those with minimal manifestations of MG.
RESULTS
Thirty-one subjects (AZA n = 15; MTX n = 16) satisfied the inclusion criteria but only 24 were randomized. Baseline characteristics were similar. There was no difference between the AZA- and MTX-groups in respect of prednisone dosing (apart from months 10 and 12), in quantitative MG Score improvement, proportions in sustained remission, frequencies of MG relapses, or adverse reactions and/or withdrawals. The MTX-group received lower prednisone doses between month 10 (p = 0.047) and month 12 (p = 0.039). At month 12 the prednisone dose per kilogram bodyweight in the MTX-group (0.15 mg/kg) was half that of the AZA-group (0.31 mg/kg)(p = 0.019).
CONCLUSIONS
This study provides evidence that in patients with generalized MG methotrexate is an effective steroid-sparing agent 10 months after treatment initiation. Our data suggests that in generalized MG methotrexate has similar efficacy and tolerability to azathioprine and may be the drug of choice in financially constrained health systems.
TRIAL REGISTRATION
SANCTR:DOH-27-0411-2436.
| 0no significant effect
|
4,270,681 | 25,593,710 |
BACKGROUND
Awareness during general anesthesia in different types of surgery is an important described adverse event. Bispectral (BIS) monitoring is one of the recent techniques proposed to monitor the depth of anesthesia.
OBJECTIVES
The present study tested the hypothesis that the awareness rate and changes in hemodynamic parameters within anesthesia would be lower in patients allocated to BIS-guided management than those allocated to routine monitoring.
MATERIALS AND METHODS
In total, 333 adult patients with the American Society of Anesthesiologists (ASA) physical status I-III, aged between 18 and 65 years scheduled for elective abdominal surgery under general anesthesia were included in this randomized double-blind placebo controlled trial. Patients were randomly allocated to BIS monitoring (n = 163) or routine monitoring (n = 170). BIS values and hemodynamic parameters including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and SPO2 were marked before induction (control value), after intubation and laryngoscopy, at intubation, after incision, and also during the operation every 15 minutes until extubation.
RESULTS
The overall incidence of awareness in the BIS and routine monitoring groups were 5.5% and 4.1%, which was not significantly different. There were no significant differences in hemodynamic indices including SBP, DBP, HR, and SPO2 before induction of anesthesia between the two groups. These between-group differences in the studied indices remained insignificant at different time points after anesthesia induction as well as post ICU hospitalization. Furthermore, the trend of changes in hemodynamic parameters was comparable in the two groups.
CONCLUSIONS
BIS-guided management may not be superior to routine monitoring protocols to prevent awareness as well as hemodynamic changes during general anesthesia in patients undergoing abdominal surgeries.
| 0no significant effect
|
5,419,060 | 28,470,073 |
BACKGROUND
There is an increasing amount of blood sample rejection at primary health care facilities (PHCFs), impacting negatively the staff, facility, patient and laboratory costs.
AIM
The primary objective was to determine the rejection rate and reasons for blood sample rejection at four PHCFs before and after a phlebotomy training programme. The secondary objective was to determine whether phlebotomy training improved knowledge among primary health care providers (HCPs) and to develop a tool for blood sample acceptability.
STUDY SETTING
Two community health centres (CHCs) and two community day centres (CDCs) in Cape Town.
METHODS
A quasi-experimental study design (before and after a phlebotomy training programme).
RESULTS
The sample rejection rate was 0.79% (n = 60) at CHC A, 1.13% (n = 45) at CHC B, 1.64% (n = 38) at CDC C and 1.36% (n = 8) at CDC D pre-training. The rejection rate remained approximately the same post-training (p > 0.05). The same phlebotomy questionnaire was administered pre- and post-training to HCPs. The average score increased from 63% (95% CI 6.97‒17.03) to 96% (95% CI 16.91‒20.09) at CHC A (p = 0.039), 58% (95% CI 9.09‒14.91) to 93% (95% CI 17.64‒18.76) at CHC B (p = 0.006), 60% (95% CI 8.84‒13.13) to 97% (95% CI 16.14‒19.29) at CDC C (p = 0.001) and 63% (95% CI 9.81‒13.33) to 97% (95% CI 18.08‒19.07) at CDC D (p = 0.001).
CONCLUSION
There is no statistically significant improvement in the rejection rate of blood samples (p > 0.05) post-training despite knowledge improving in all HCPs (p < 0.05).
| 0no significant effect
|
4,293,505 | 25,589,945 |
BACKGROUND
Postoperative nausea and vomiting (PONV), postanesthetic shivering and pain are common postoperative patient complaints that can result in adverse physical and psychological outcomes. Some antiemetics are reported to be effective in the management of postoperative pain and shivering, as well as PONV. We evaluated the efficacy of dexamethasone added to ramosetron on PONV, shivering and pain after thyroid surgery.
METHODS
One hundred and eight patients scheduled for thyroid surgery were randomly allocated to three different groups: the control group (group C, n = 36), the ramosetron group (group R, n = 36), or the ramosetron plus dexamethasone group (group RD, n = 36). The patients were treated intravenously with 1 and 2 ml of 0.9% NaCl (group C); or 2 ml of 0.15 mg/ml ramosetron plus 1 ml of 0.9% NaCl (group R); or 2 ml of 0.15 mg/ml ramosetron plus 1 ml of 5 mg/ml dexamethasone (group RD) immediately after anesthesia.
RESULTS
Incidence of nausea and the need for rescue antiemetics, verbal rating scale (VRS) 1 hour pain value, ketorolac consumption, and incidence of shivering were significantly lower in group R and group RD, than in group C (P < 0.05). Moreover, these parameters were significantly lower in group RD than in group R (P < 0.05).
CONCLUSIONS
Combination of ramosetron and dexamethasone significantly reduced not only the incidence of nausea and need for rescue antiemetics, but also the VRS 1 hour pain value, ketorolac consumption, and the incidence of shivering compared to ramosetron alone in patients undergoing thyroid surgery.
| 1significant effect
|
3,788,226 | 24,106,352 |
BACKGROUND
Truview laryngoscope provides an indirect view of the glottis and will cause less cervical spine movement since a ventral lifting force will not be required to visualize the glottis compared to Macintosh laryngoscope.
MATERIALS AND METHODS
A randomized crossover study to assess the degree of movement of cervical spine during endotracheal intubation with Truview laryngoscope was conducted in 25 adult ASA-I patients. After a standard anesthetic technique laryngoscopy was performed twice in each patient using in turn both the Macintosh and Truview laryngoscopes. A baseline radiograph with the head and neck in a neutral position was followed by a second radiograph taken during each laryngoscopy. An experienced radiologist analyzed and measured the cervical movement.
RESULTS
Significant cervical spine movement occurred at all segments when compared to the baseline with both the Macintosh and Truview laryngoscopes (P < 0.001). However, the movement was significantly less with Truview compared to the Macintosh laryngoscope at C0-C1 (21%; P = 0.005) and C1-C2 levels (32%; P = 0.009). The atlantooccipital distance (AOD) traversed while using Truview laryngoscope was significantly less than with Macintosh blade (26%; P = 0.001). Truview blade produced a better laryngoscopic view (P = 0.005) than Macintosh blade, but had a longer time to laryngoscopy (P = 0.04).
CONCLUSION
Truview laryngoscope produced a better laryngoscopic view of glottis as compared with Macintosh laryngoscopy. It also produced significantly less cervical spine movement at C0-C1 and C1-C2 levels than with Macintosh laryngoscope in patients without cervical spine injury and without manual in-line stabilization (MILS). Further studies are warranted with Truview laryngoscope using MILS.
| 1significant effect
|
3,302,141 | 23,455,021 |
BACKGROUND
Behavioral lifestyle intervention, combined with parental involvement, is preferred over standard care or self-help in childhood obesity. The short-term results of such interventions are promising, but long-term follow-up results are equivocal.
OBJECTIVE
The objective of the present study was the short (3 months) and long-term (1 and 2 years follow-up) effect evaluation of a family-based multidisciplinary cognitive behavioral lifestyle intervention on markers of adiposity, metabolism, inflammation and physical fitness compared with standard care in children with obesity. Also the association between these outcome variables was determined.
METHODS
In this prospective longitudinal clinical trial, obese children were randomly assigned to a 3-month family-based cognitive behavioral multidisciplinary lifestyle treatment (n=40; body mass index-standard deviation score (BMI-SDS) 4.2±0.7; age; 13.3±2.0 years) or to a control group receiving an initial advice on physical activity and nutrition (n=39; BMI-SDS 4.3±0.6; age 13.1±1.9 years). Anthropometric data, physical fitness, metabolic parameters and inflammatory state were evaluated at baseline, after intervention (at 3 months) and at 1-year follow-up. At 2-year follow-up, anthropometric data and physical fitness were measured in the intervention group.
RESULTS
An intervention effect after 1 year was found for adiposity (P=0.02 for BMI-SDS, P=0.03 for waist circumference (WC)-SDS), physical fitness (absolute measured peak value of oxygen uptake (ml min(-1)), standardized for age and gender (VO2peak-SDS), P<0.01) and insulin resistance (HOMA-SDS, P=0.04). No significant intervention effect was found for serum lipid profile, high-sensitive C-reactive protein or for adiponectin. At 2-year follow-up, BMI-SDS in the intervention group (n=31) was 3.8±1.2 SDS, significantly less than at baseline (P=0.02).
CONCLUSION
A positive 1-year follow-up treatment effect was found for adiposity, physical fitness and glucose homeostasis, but not for inflammatory markers. There was a significant long-term treatment effect on adiposity, although almost all children remained obese.
| 1significant effect
|
5,033,379 | 27,658,215 |
BACKGROUND
In India, although the proportion of institutional births is increasing, there are concerns regarding quality of care. We assessed the effectiveness of a nurse-led onsite mentoring program in improving quality of care of institutional births in 24/7 primary health centres (PHCs that are open 24 hours a day, 7 days a week) of two high priority districts in Karnataka state, South India. Primary outcomes were improved facility readiness and provider preparedness in managing institutional births and associated complications during child birth.
METHODS
All functional 24/7 PHCs in the two districts were included in the study. We used a parallel, cluster randomized trial design in which 54 of 108 facilities received six onsite mentoring visits, along with an initial training update and specially designed case sheets for providers; the control arm received just the initial training update and the case sheets. Pre- and post-intervention surveys were administered in April-2012 and August-2013 using facility audits, provider interviews and case sheet audits. The provider interviews were administered to all staff nurses available at the PHCs and audits were done of all the filled case sheets during the month prior to data collection. In addition, a cost analysis of the intervention was undertaken.
RESULTS
Between the surveys, we achieved coverage of 100% of facilities and 91.2% of staff nurse interviews. Since the case sheets were newly designed, case-sheet audit data were available only from the end line survey for about 80.2% of all women in the intervention facilities and 57.3% in the control facilities. A higher number of facilities in the intervention arm had all appropriate drugs, equipment and supplies to deal with gestational hypertension (19 vs.3, OR (odds ratio) 9.2, 95% C.I 2.5 to33.6), postpartum haemorrhage (29 vs. 12, OR 3.7, 95% C.I 1.6 to8.3); and obstructed labour (25 vs.9, OR 3.4, 95% CI 1.6 to8.3). The providers in the intervention arm had better knowledge of active management of the third stage of labour (82.4% vs.35.8%, AOR (adjusted odds ratio) 10, 95% C.I 5.5 to 18.2); management of maternal sepsis (73.5% vs. 10.9%, AOR 36.1, 95% C.I 13.6 to 95.9); neonatal resuscitation (48.5% vs.11.7%, AOR 10.7, 95% C.I 4.6 to 25.0) and low birth weight newborn care (58.1% vs. 40.9%, AOR 2.4, 95% C.I 1.2 to 4.7). The case sheet audits revealed that providers in the intervention arm showed greater compliance with the protocols during labour monitoring (77.3% vs. 32.1%, AOR 25.8, 95% C.I 9.6 to 69.4); delivery and immediate post-partum care for mothers (78.6% vs. 31.8%, AOR 22.1, 95% C.I 8.0 to 61.4) and for newborns (73.9% vs. 32.8%, AOR 24.1, 95% C.I 8.1 to 72.0). The cost analysis showed that the intervention cost an additional $5.60 overall per delivery.
CONCLUSIONS
The mentoring program successfully improved provider preparedness and facility readiness to deal with institutional births and associated complications. It is feasible to improve the quality of institutional births at a large operational scale, without substantial incremental costs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02004912.
| 1significant effect
|
3,551,224 | 22,562,973 |
OBJECTIVE
To assess the efficacy and safety of adalimumab plus methotrexate (ADA+MTX) compared with methotrexate monotherapy in achieving stable low disease activity (LDA; disease activity score (DAS28(CRP)) <3.2 at weeks 22 and 26) and clinical, radiographic and functional outcomes in methotrexate-naive patients with early rheumatoid arthritis (RA).
METHODS
1032 patients with active RA were randomly assigned 1:1 to ADA+MTX or placebo plus methotrexate (PBO+MTX) for 26 weeks. Treatment modifications were to be made in a subsequent study period based on the achievement of DAS28(CRP) <3.2 at weeks 22 and 26. Post-hoc analyses compared patients achieving stable remission using DAS28 and 2010 ACR/EULAR criteria with those achieving LDA but not remission.
RESULTS
Among patients completing 6 months, 44% (207/466) ADA+MTX versus 24% (112/460) PBO+MTX patients achieved stable LDA at weeks 22 and 26 (p<0.001). Combination therapy was statistically superior to methotrexate in obtaining higher ACR20/50/70 responses, more clinical remissions, greater mean reductions in DAS28(CRP), no radiographic progression, and normal functional status at week 26 (p<0.001 for all). The only factor predicting stable LDA was disease activity at week 12. Patients achieving ACR/EULAR remission, particularly in the PBO+MTX group, had some advantage in radiographic outcomes compared with patients who only achieved LDA (but not remission). The overall frequency of adverse events was comparable between groups. There were more serious infections and deaths in the ADA+MTX group, with a possible age effect.
CONCLUSIONS
Treatment with ADA+MTX was significantly superior to methotrexate alone with respect to clinical, radiographic and functional outcomes in patients with early active RA. Before initiating treatment with adalimumab, individual patient evaluation of the benefit/risk ratio should be carefully considered.
| 1significant effect
|
4,355,443 | 25,373,796 |
PURPOSE
To prospectively compare SIRT and DEB-TACE for treating hepatocellular carcinoma (HCC).
METHODS
From 04/2010-07/2012, 24 patients with histologically proven unresectable N0, M0 HCCs were randomized 1:1 to receive SIRT or DEB-TACE. SIRT could be repeated once in case of recurrence; while, TACE was repeated every 6 weeks until no viable tumor tissue was detected by MRI or contraindications prohibited further treatment. Patients were followed-up by MRI every 3 months; the final evaluation was 05/2013.
RESULTS
Both groups were comparable in demographics (SIRT: 8males/4females, mean age 72 ± 7 years; TACE: 10males/2females, mean age 71 ± 9 years), initial tumor load (1 patient ≥25 % in each group), and BCLC (Barcelona Clinic Liver Cancer) stage (SIRT: 12×B; TACE 1×A, 11×B). Median progression-free survival (PFS) was 180 days for SIRT versus 216 days for TACE patients (p = 0.6193) with a median TTP of 371 days versus 336 days, respectively (p = 0.5764). Median OS was 592 days for SIRT versus 788 days for TACE patients (p = 0.9271). Seven patients died in each group. Causes of death were liver failure (n = 4 SIRT group), tumor progression (n = 4 TACE group), cardiovascular events, and inconclusive (n = 1 in each group).
CONCLUSIONS
No significant differences were found in median PFS, OS, and TTP. The lower rate of tumor progression in the SIRT group was nullified by a greater incidence of liver failure. This pilot study is the first prospective randomized trial comparing SIRT and TACE for treating HCC, and results can be used for sample size calculations of future studies.
| 0no significant effect
|
4,734,818 | 26,869,754 |
PURPOSE
To compare the effect of two ocular viscosurgical devices (OVDs) on intraocular pressure (IOP) and surgical time in immediate postoperative period after bilateral implantable collamer lens (using the V4c model) implantation.
METHODS
A total of 20 eligible patients were randomized to receive 2% hydroxypropylmethylcellulose (HPMC) in one eye and 1% hyaluronic acid in fellow eye. Time taken for complete removal of OVD and total surgical time were recorded. At the end of surgery, IOP was adjusted between 15 and 20 mmHg in both the eyes.
RESULTS
Mean time for complete OVD evacuation and total surgical time were significantly higher in the HPMC group (P=0.00). Four eyes in the HPMC group had IOP spike, requiring treatment. IOP values with noncontact tonometry at 1, 2, 4, 24, and 48 hours were not statistically significant (P>0.05) for both the groups.
CONCLUSION
The study concluded that 1% hyaluronic acid significantly reduces total surgical time, and incidence of acute spikes may be lower compared to 2% HPMC when used for implantable collamer lens (V4c model).
| 0no significant effect
|
3,326,921 | 22,529,484 |
OBJECTIVE
To compare the cure rates of oral single dose of metronidazole (2 g), tinidazole (2 g), secnidazole (2 g), and ornidazole (1.5 g) in cases of bacterial vaginosis.
MATERIALS AND METHODS
This was a prospective, comparative, randomized clinical trial on 344 Indian women (86 women in each group) who attended a gynecology outpatient department with complaint of abnormal vaginal discharge or who had abnormal vaginal discharge on Gynecological examination but they did not complaint of it. For diagnosis and cure rate of bacterial vaginosis, Amsel's criteria were used. Statistical analysis was done by Chi-square test of proportions. The cure rate was compared considering metronidazole cure rate as gold standard.
RESULTS
At 1 week, the cure rate of tinidazole and ornidazole was 100% and at 4 weeks, it was 97.7% for both drugs (P<0.001). Secnidazole had cure rate of 80.2% at 4 weeks (P=NS). Metronidazole showed a cure rate of 77.9% at 4 weeks, which is the lowest of all four drugs.
CONCLUSION
Tinidazole and ornidazole have better cure rate as compared to metronidazole in cases of bacterial vaginosis.
| 0no significant effect
|
5,129,050 | 27,836,873 |
OBJECTIVES
Assess the feasibility of implementing the GoActive intervention in secondary schools, to identify improvements, test study procedures, determine preliminary effectiveness to increase moderate-to-vigorous physical activity (MVPA), and inform power calculations to establish programme effectiveness.
SETTING
Feasibility study (1 school) and pilot cluster-randomised controlled trial (CRCT; 2 intervention; 1 control school(s)).
PARTICIPANTS
460 participants (46.6% female; 13.2 (0.4) years old).
INTERVENTIONS
8-week intervention (2013) involved: classes choosing weekly activities encouraged by mentors (older adolescents) and in-class peer leaders. Students gain points for trying activities which are entered into an intramural competition.
PRIMARY AND SECONDARY OUTCOME MEASURES
Planned quantitative (questionnaire) and qualitative (focus groups) process evaluation addressed enjoyment, confidence, participation, suggested improvements. Outcomes were assessed at baseline and follow-up (week 8) in pilot CRCT and included accelerometer-assessed MVPA; adolescent-reported activity type, well-being, peer support, shyness, sociability. Analysis of covariance was used to assess preliminary effectiveness as change in MVPA adjusted for baseline.
RESULTS
All year 9 students in intervention schools were exposed to the intervention; over all schools 77% of eligible students were measured. 71% boys and 74% girls found GoActive 'fun'; 38% boys and 32% girls said it increased confidence, and 64% boys and 59% girls said they would continue with a GoActive activity. Suggested improvements included more mentorship; improved training; streamlined points recording. Pilot results indicated potential effectiveness ((adjusted mean difference (95% CI) p value; MVPA mins; 5.1 (1.1 to 9.2) p=0.014)) and suggest recruitment of 16 schools (2400 adolescents) for a full trial. Compared with control, intervention students reported greater peer support 0.5 (0.1 to 0.9) p=0.03, well-being 1.8 (0.1 to 3.4) p=0.04 but no difference in shyness/sociability. Participation in activity types approached significance (intervention group 2.3 (-0.2 to 4.7) p=0.07 more activity types).
CONCLUSIONS
Results suggest feasibility and indicate potential effectiveness of GoActive to increase MVPA and support a fully powered evaluation of effectiveness and cost-effectiveness. Process evaluation data were used to refine GoActive prior to a full trial.
TRIAL REGISTRATION NUMBER
ISRCTN31583496; pre-results.
| 1significant effect
|
4,751,474 | 25,315,207 |
OBJECTIVE
Medication nonadherence is a major obstacle to better control of glucose, blood pressure (BP), and LDL cholesterol in adults with diabetes. Inexpensive effective strategies to increase medication adherence are needed.
RESEARCH DESIGN AND METHODS
In a pragmatic randomized trial, we randomly assigned 2,378 adults with diabetes mellitus who had recently been prescribed a new class of medication for treating elevated levels of glycated hemoglobin (A1C) ≥8% (64 mmol/mol), BP ≥140/90 mmHg, or LDL cholesterol ≥100 mg/dL, to receive 1) one scripted telephone call from a diabetes educator or clinical pharmacist to identify and address nonadherence to the new medication or 2) usual care. Hierarchical linear and logistic regression models were used to assess the impact on 1) the first medication fill within 60 days of the prescription; 2) two or more medication fills within 180 days of the prescription; and 3) clinically significant improvement in levels of A1C, BP, or LDL cholesterol.
RESULTS
Of the 2,378 subjects, 89.3% in the intervention group and 87.4% in the usual-care group had sufficient data to analyze study outcomes. In intent-to-treat analyses, intervention was not associated with significant improvement in primary adherence, medication persistence, or intermediate outcomes of care. Results were similar across subgroups of patients defined by age, sex, race/ethnicity, and study site, and when limiting the analysis to those who completed the intended intervention.
CONCLUSIONS
This low-intensity intervention did not significantly improve medication adherence or control of glucose, BP, or LDL cholesterol. Wide use of this strategy does not appear to be warranted; alternative approaches to identify and improve medication adherence and persistence are needed.
| 0no significant effect
|
4,282,314 | 24,147,918 |
BACKGROUND
Effective approaches are needed to address the increasing prevalence of overweight and obesity. The present study investigated whether all meal provision was a more effective and acceptable method for weight loss than a self-directed diet.
METHODS
This randomised controlled trial recruited 112 men and women with a body mass index in the range 27-35 kg m(-2), who had no comorbidities, from the local area of Hull. Participants were randomised to receive either meal provision or follow a self-directed diet for a 12-week period that resulted in an estimated 2928 kJ day(-1) (700 kcal day(-1)) deficit. A dietitian supervised both dietary interventions.
RESULTS
At 12 weeks [mean (SEM)], percentage weight loss in the meal provision group was 6.6% (0.5%) compared to 4.3% (0.6%) for those on the self-directed diet. In terms of clinically relevant weight loss, 61% of participants lost 5% or more of their body weight with meal provision compared to 22% on the self-directed diet (P < 0.001). Weight loss was associated with wellbeing in both groups. Attrition was less apparent with 7% of those participants receiving meal provision withdrawing from the study compared to 41% of those following the self-directed diet (P < 0.001).
CONCLUSIONS
Meal provision was a more effective and accepted method for weight loss over a 12-week period compared to a self-directed diet. This may in part represent the difference between being given the meal provision food free of charge. However, longer-term maintenance studies need to be undertaken to ascertain their effects on the maintenance of weight loss.
| 1significant effect
|
5,754,420 | 29,119,246 |
PURPOSE
To examine the skeletal muscle and performance responses across two different exercise training modalities which are highly applied in soccer training.
METHODS
Using an RCT design, 39 well-trained male soccer players were randomized into either a speed endurance training (SET; n = 21) or a small-sided game group (SSG; n = 18). Over 4 weeks, thrice weekly, SET performed 6-10 × 30-s all-out runs with 3-min recovery, while SSG completed 2 × 7-9-min small-sided games with 2-min recovery. Muscle biopsies were obtained from m. vastus lateralis pre and post intervention and were subsequently analysed for metabolic enzyme activity and muscle protein expression. Moreover, the Yo-Yo Intermittent Recovery level 2 test (Yo-Yo IR2) was performed.
RESULTS
Muscle CS maximal activity increased (P < 0.05) by 18% in SET only, demonstrating larger (P < 0.05) improvement than SSG, while HAD activity increased (P < 0.05) by 24% in both groups. Na + -K + ATPase α 1 subunit protein expression increased (P < 0.05) in SET and SSG (19 and 37%, respectively), while MCT4 protein expression rose (P < 0.05) by 30 and 61% in SET and SSG, respectively. SOD2 protein expression increased (P < 0.05) by 28 and 37% in SET and SSG, respectively, while GLUT-4 protein expression increased (P < 0.05) by 40% in SSG only. Finally, SET displayed 39% greater improvement (P < 0.05) in Yo-Yo IR2 performance than SSG.
CONCLUSION
Speed endurance training improved muscle oxidative capacity and exercise performance more pronouncedly than small-sided game training, but comparable responses were in muscle ion transporters and antioxidative capacity in well-trained male soccer players.
| 1significant effect
|
4,876,157 | 27,218,026 |
BACKGROUND
One-per-mil tumescent solution, which contains 0.2% lidocaine with 1:1,000,000 epinephrine, has been reported to be clinically effective for hand surgery under local anesthesia. However, it was lacking in its basic pharmacokinetics profile in regard to the onset of action (OOA) and duration of action (DOA).
METHODS
A randomized, double-blind study was conducted on 12 volunteers who met the inclusion criteria from October to November 2014. All volunteers had their right and left ring finger pulps injected with either one-per-mil solution or 2% lidocaine. Semmes-Weinstein and two-point discrimination tests were used to test sensation. Visual analogue scale was recorded at the time when the finger lost its sensation and when it regained normal sensation to measure the OOA and DOA. The data were then analyzed with a paired t-test and a Wilcoxon signed-rank test.
RESULTS
The OOA and DOA of 2% plain lidocaine were 1 minute and 99.67 minutes, respectively. Meanwhile, 0.2% lidocaine in a one-per-mil tumescent solution showed an OOA of 5 minutes and a DOA of 186.83 minutes. The OOA of 0.2% lidocaine in a one-per-mil tumescent solution is statistically shorter than 2% plain lidocaine (P=0.04); while its DOA is statistically longer than 2% plain lidocaine (P<0.001).
CONCLUSIONS
The 0.2% lidocaine in a one-per-mil tumescent solution is statistically and clinically superior to 2% plain lidocaine in achieving longer duration of local anesthesia.
| 1significant effect
|
5,655,938 | 29,065,875 |
BACKGROUND
Asian medical students and doctors receive lower scores on average than their white counterparts in examinations in the UK and internationally (a phenomenon known as "differential attainment"). This could be due to examiner bias or to social, psychological or cultural influences on learning or performance. We investigated whether students' scores or feedback show influence of ethnicity-related bias; whether examiners unconsciously bring to mind (activate) stereotypes when judging Asian students' performance; whether activation depends on the stereotypicality of students' performances; and whether stereotypes influence examiner memories of performances.
METHODS
This is a randomised, double-blinded, controlled, Internet-based trial. We created near-identical videos of medical student performances on a simulated Objective Structured Clinical Exam using British Asian and white British actors. Examiners were randomly assigned to watch performances from white and Asian students that were either consistent or inconsistent with a previously described stereotype of Asian students' performance. We compared the two examiner groups in terms of the following: the scores and feedback they gave white and Asian students; how much the Asian stereotype was activated in their minds (response times to Asian-stereotypical vs neutral words in a lexical decision task); and whether the stereotype influenced memories of student performances (recognition rates for real vs invented stereotype-consistent vs stereotype-inconsistent phrases from one of the videos).
RESULTS
Examiners responded to Asian-stereotypical words (716 ms, 95% confidence interval (CI) 702-731 ms) faster than neutral words (769 ms, 95% CI 753-786 ms, p < 0.001), suggesting Asian stereotypes were activated (or at least active) in examiners' minds. This occurred regardless of whether examiners observed stereotype-consistent or stereotype-inconsistent performances. Despite this stereotype activation, student ethnicity had no influence on examiners' scores; on the feedback examiners gave; or on examiners' memories for one performance.
CONCLUSIONS
Examiner bias does not appear to explain the differential attainment of Asian students in UK medical schools. Efforts to ensure equality should focus on social, psychological and cultural factors that may disadvantage learning or performance in Asian and other minority ethnic students.
| 0no significant effect
|
3,882,495 | 24,364,899 |
BACKGROUND
There are wide variations in the physical designs and attributes between different brands of intravenous cannulae that makes product selection and purchasing difficult. In a systematic assessment to guide purchasing, we assessed two cannulae - Cannula P and I. We proposed that the results of in-vitro performance testing of the cannulae would be associated with preference after clinical comparison.
METHODS
We designed an observer-blinded randomised head-to-head trial between the 18, 20 and 22 gauge versions of Cannula P and I. Our primary end-point was pressure (mmHg) generated during various flow rates and our secondary end-point was the force (Newton) required to slide the catheter away from the needle. This was followed by a prospective electronic survey following a two-week clinical trial period.
RESULTS
The mean difference in resistance between Cannula P and I was: 307 mmHg.L-1.hr-1 (95% CI: 289-325, p < 0.001) for 22G; 135 mmHg.L-1.hr-1 (95% CI: 125-144, p < 0.001) for 20G; and 27 mmHg.L-1.hr-1 (95% CI: 26-28, p < 0.001) for 18G. The mean difference in the force needed to displace the catheter away from its needle was: 1.41 N (95% CI: 1.09-1.73, p < 0.001) for 22G; 0.19 N (95% CI: -0.04-0.41, p = 0.12) for 20G; and 1.96 N (95% CI: 1.40-2.52, p < 0.001) for 18G. After a trial period, all 16 anaesthetist who had used both cannulae preferred Cannula I to P.
CONCLUSIONS
The evaluation process described here could help hospitals improve efficient product selection and purchasing decisions for intravenous cannulae.
| 1significant effect
|
3,816,860 | 24,026,560 |
OBJECTIVE
Preclinical data suggest that linagliptin, a dipeptidyl peptidase-4 inhibitor, may lower urinary albumin excretion. The ability of linagliptin to lower albuminuria on top of renin-angiotensin-aldosterone system (RAAS) inhibition in humans was analyzed by pooling data from four similarly designed, 24-week, randomized, double-blind, placebo-controlled, phase III trials.
RESEARCH DESIGN AND METHODS
A pooled analysis of four completed studies identified 217 subjects with type 2 diabetes and prevalent albuminuria (defined as a urinary albumin-to-creatinine ratio [UACR] of 30-3,000 mg/g creatinine) while receiving stable doses of RAAS inhibitors. Participants were randomized to either linagliptin 5 mg/day (n = 162) or placebo (n= 55). The primary end point was the percentage change in geometric mean UACR from baseline to week 24.
RESULTS
UACR at week 24 was reduced by 32% (95% CI -42 to -21; P < 0.05) with linagliptin compared with 6% (95% CI -27 to +23) with placebo, with a between-group difference of 28% (95% CI -47 to -2; P = 0.0357). The between-group difference in the change in HbA1c from baseline to week 24 was -0.61% (-6.7 mmol/mol) in favor of linagliptin (95% CI -0.88 to -0.34% [-9.6 to -3.7 mmol/mol]; P < 0.0001). The albuminuria-lowering effect of linagliptin, however, was not influenced by race or HbA1c and systolic blood pressure (SBP) values at baseline or after treatment.
CONCLUSIONS
Linagliptin administered in addition to stable RAAS inhibitors led to a significant reduction in albuminuria in patients with type 2 diabetes and renal dysfunction. This observation was independent of changes in glucose level or SBP. Further research to prospectively investigate the renal effects of linagliptin is underway.
| 1significant effect
|
5,154,016 | 27,955,644 |
BACKGROUND
Spinal fusion surgery is associated with significant blood loss, which may result in potential clinical complications, it is necessary to take safe and effective measures to reduce blood loss in surgery. We perform this study to assess the impact of three different hemostatic materials on perioperative blood loss.
METHODS
We performed a Randomized Controlled Trial research and recruited patients with lumbar disease into the study between November 2013 and March 2015. All the participants were randomly assigned to 3 groups using a simple equal probability randomization scheme: Group A (Stypro hemostatic sponge), Group B (Collagen hemostatic sponge) and Group C (gelatin sponge). We compared postoperative blood loss between these 3 groups.
RESULTS
In our study, drainage volume in the first 24 h of patients in Group A and B is significantly smaller, as well as total postoperative volumes of drainage (p < 0.05) during their hospital stay. The drainage volumes in the second 24 h were similar in the 3 groups. We also found that the average drainage Hematocrit (HCT) reduced over time, the average HCT of drainage is 18.04% and 11.72% on the first day and on the second day respectively.
CONCLUSIONS
Hemostatic collagen sponge demonstrated better hemostasis effects than gelatin sponge with lower volume of postoperative drainage volume and blood loss in posterior spinal fusion surgery.
TRIAL REGISTRATION
The trial registration number (TRN) of the study is ISRCTN29254316 and date of registration is 25/10/2016. Our trial was registered retrospectively.
| 1significant effect
|
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